• Author / Uploaded
• Olesea Rîhlea

Citation preview

0 Table of Contents

1 Introduction

2 Theory of Operation

3 Post-Service Checkout 4 Tests and Calibrations

1.1 What this manual includes 1.1.1 Software and hardware revision 1.2 Standard service procedures 1.2.1 User Manual 1.2.2 Ventilator tests 1.3 Symbols used for this manual or the equipment 1.4 Abbreviations used for this manual or the equipment

1-2 1-2 1-3 1-3 1-3 1-4 1-6

2.1 General description 2.2 elisa ventilator features 2.2.1 Safety features 2.3 elisa ventilator main assemblies 2.4 Electrical components 2.5 Pneumatic components

2-2 2-3 2-3 2-4 2-5 2-12

3.1 Post-service checkout

3-2

4.1 Self tests 4.1.1 Power-up test 4.1.2 System test 4.1.3 In-operation test See next page for more

4-2 4-2 4-3 4-6

TM, elisa, CM-922280, rev. 3.03.a

0-1

0 Table of Content

4 Tests and Calibrations (continued)

5 Troubleshooting

6 Maintenance

7 Repair procedures

0-2

4.2 Test lung test 4.3 Service mode 4.4 Service mode check 4.5 Software and hardware revision 4.6 Ventilator “on-time” 4.7 Calibrations 4.7.1 O2 sensor calibration 4.7.2 Location of calibration points 4.7.3 AIR flow calibration 4.7.4 O2 flow calibration 4.7.5 Expiratory flow sensor calibration 4.7.6 Airway pressure sensor calibration 4.7.7 Overpressure relief valve calibration 4.8 Battery test 4.9 Free breathing valve test 4.10 Diagnostic test 4.11 Eventlog and trend download (service log)

4-7 4-10 4-12 4-14 4-15 4-16 4-17 4-19 4-20 4-22 4-24 4-28 4-30 4-32 4-34 4-35 4-37

5.1 Troubleshooting instructions 5.2 Alarms 5.3 Messages 5.3.1 Messages during power-up test 5.3.2 Messages during system test 5.3.3 Messages during O2 sensor calibration 5.3.4 Messages during operation 5.3.5 System shut down messages

5-2 5-4 5-11 5-11 5-16 5-27 5-28 5-32

6.1 General instructions 6.2 Maintenance schedule 6.2.1 Every twelve (12) months 6.2.2 Every twenty-four (24) months 6.2.3 Every sixty (60) month

6-2 6-3 6-3 6-4 6-4

7.1 General instructions 7.2 Open the system 7.2.1 Remove the exp. valve 7.2.2 Remove the control panel 7.2.3 Open the control panel 7.2.4 Control panel assemblies 7.2.5 Open the main engine 7.2.6 Remove the control panel mounting plate 7.2.7 Main engine assemblies 7.3 Service assemblies 7.4 Change the line voltage 7.5 Software replacement 7.5.1 Change the (A) EPROM See next page for more

7-3 7-4 7-5 7-8 7-9 7-10 7-11 7-12 7-13 7-15 7-16 7-17 7-18

TM, elisa, CM-922280, rev. 3.03.a

1 Table of Content

7 Repair procedures (continued)

8 Illustrated Parts

7.5.2 Change the main (B) EPROM 7.6 Change the unit of pressure 7.7 Change fuses 7.7.1 Line fuses 7.7.2 Control panel fuses 7.7.3 Main engine fuses 7.8 Repair control panel components 7.8.1 Replace Selector encoder 7.8.2 Replace PC board A 7.8.3 Replace Li-battery on PC board A 7.8.4 Replace PC board DCU 7.8.5 Replace LCD screen 7.8.6 Replace front housing with touch screen 7.8.7 Replace back cover 7.9 Repair main engine components 7.9.1 Remove back-up battery 7.9.2 Repair expiratory valve 7.9.3 Replace expiratory valve locking assembly 7.9.4 Replace expiratory valve locking spring 7.9.5 Repair inspiratory connection 7.9.6 Replace O2 sensor 7.9.7 Repair ON-Off switch 7.9.8 Replace or install On/Off switch interface PC board 7.9.9 Replace gas inlet connectors 7.9.10 Replace gas inlet filters 7.9.11 Replace pneumatic assembly 7.9.12 Replace free breathing valve 7.9.13 Replace PC board B 7.9.14 Replace alarm speaker B 7.9.15 Remove sub chassis 7.9.16 Replace transformer 7.9.17 Replace fan 7.9.18 Replace line connector 7.9.19 Replace DC mains connector 7.9.20 Replace ground connector 7.9.21 Replace serial data connector 8.1 Special instructions 8.2 Service tools 8.2.1 Calibration accessories kit, ST 2 8.2.2 Test lung kit, ST 3 8.2.3 “Service” flow screen ST5 8.2.4 Tool kit, ST 4 8.2.5 Test equipment specifications 8.2.6 Service cable 8.2.7 Service kit See next page for more

TM, elisa, CM-922280, rev. 3.03.a

7-19 7-20 7-21 7-21 7-22 7-23 7-24 7-24 7-25 7-27 7-28 7-29 7-30 7-31 7-32 7-32 7-33 7-34 7-35 7-36 7-37 7-38 7-39 7-40 7-41 7-42 7-43 7-44 7-45 7-46 7-47 7-48 7-49 7-50 7-51 7-52 8-2 8-2 8-2 8-2 8-2 8-3 8-3 8-4 8-4

0-3

0 Table of Content

8 Illustrated Parts

8.3 Software 8.3.1 Software kit 8.4 Control panel spare parts 8.5 Expiration valve spare parts 8.6 Main engine spare parts

8-5 8-5 8-6 8-12 8-14

9 Schematics and Diagrams

9.1 Pneumatic diagram 9.2 Electrical diagram 9.3 Component layout, PC board B 9.4 Component layout, PC board A 9.5 Tubes and connectors 9.6 Cable Routing 9.6.1 Cable routing for PC board B 9.6.2 Cable harness fixing routing 9.6.3 Pneumatic hose routing 9.7 List of fuses 9.8 Screw connectors 9.9 Accepted ranges 9.10 Sensor data ranges 9.11 DIP switch settings 9.12 Serial data transfer

9-2 9-4 9-6 9-7 9-8 9-11 9-11 9-14 9-14 9-15 9-16 9-17 9-18 9-18 9-19

10.1 elisa configuration mode 10.1.1 Access to configuration mode 10.1.2 Configuration modality 10.1.3 Exit configuration mode 10.1.4 Configuration parameters 10.2 Optionalization mode 10.2.1 Access to optionalization mode 10.2.2 Optionalization modality 10.2.3 Exit optionalization mode

10-2 10-3 10-5 10-6 10-7 10-9 10-10 10-11 10-13

11.1 External battery pack 11.1.1 Replace battery 11.1.2 Replace battery pack connector cable 11.1.3 Replace fuse 0.8 A 11.1.4 Replace fuse 3.15 A 11.1.5 Spare parts for external battery pack 11.2 Cart 11.3 Compressor 11.4 Support arm

11-2 11-2 11-3 11-4 11-4 11-5 11-8 11-9 11-10

A 1.1 Service Log Downloader

A1-2

10 Configuration and optionalization

11 Optional accessories

A1 Appendix

0-4

TM, elisa, CM-922280, rev. 3.03.a

1 Introduction

In this section

1.1 What this manual includes 1.1.1 Software and hardware revision 1.2 Standard service procedures 1.2.1 User Manual 1.2.2 Ventilator tests 1.3 Symbols used for this manual or the equipment 1.4 Abbreviations used for this manual or the equipment

TM, elisa, CM-922280, rev. 3.03.a

1-2 1-2 1-3 1-3 1-3 1-4 1-6

1-1

1 Introduction

1.1 What this manual includes This manual covers the service information for the elisa CC ventilator

1.1.1 Software and hardware revision

This manual includes test and calibration procedures for software revision 3.nn.p. and hardware revision 3/4, including options -

“Newborn”

The software (SW) and the hardware (HW) revision code are displayed during the ventilator power-up test and during the system test in the upper left corner in the screen.

The software revision code “3.nn.p” identifies: - 3. = elisa - nn. = current base software release - p = current patch number of software release (bug fixing level) The hardware revision code “o / r” identifies: - o = front panel hardware revision - r = main engine hardware revision.

1-2

TM, elisa, CM-922280, rev. 3.03.a

1 Introduction

1.2 Standard service procedures 1.2.1 User Manual

1.2.2 Ventilator tests

You must have, and be familiar with, the User Manual for this product. Study the elisa CC ventilator User Manual if you need further information about the operation of the system. Service calibration functions let trained service personnel perform ventilator setup functions, tests, measurements and calibrations from the front panel display. Normal operational tests, calibrations and troubleshooting can be performed on the elisa without opening the system’s cabinet. Repair will require opening the system’s cabinet. Calibration of the following parameters requires opening the system’s cabinet: • Inspiratory O2 flow • Inspiratory AIR flow • Expiratory flow • Airway pressure • Battery charging voltage

WARNING

After the elisa has been serviced, you must perform “Post Service Checkout” to verify the system is properly functioning before the system can be returned to clinical use.

WARNING

Do not perform tests or maintenance on this instrument while it is being used to ventilate a patient, possible injury may result.

Special notice

Some information in this manual can possibly point the reader to electronic troubleshooting and component repair/replacement level of service. This information, when supplied, is only supplied to add clarity to service or troubleshooting statements. Heinen + Löwenstein Service Personnel are mandated by Company Policy to service electronic equipment to a board replacement level only. • Read completely through each step in every procedure before starting the procedure; any exceptions can result in a failure to complete the attempted procedure properly and safely. • Unless otherwise specified, values in this manual are nominal. • Sections in this manual begin on odd numbered or right-hand pages. If there is no text on the preceding, backup even numbered page, it is labeled “Notes” for your use if you wish. • Figures that require more than one page have the title and main text on the left (even numbered) page. Additional figure information is on the facing (odd numbered) page. The elisa CC ventilator may be used together with additional accessories, such as trolleys, compressors etc. These accessories come with a separate service manual. Use this manual together with the manuals for additional accessories.

TM, elisa, CM-922280, rev. 3.03.a

1-3

1 Introduction

1.3 Symbols used for this manual or the equipment Warnings and Cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual.

WARNING CAUTION

Warnings indicate a condition that can cause injury to the operator or the patient. Cautions indicate a condition that can cause damage to the equipment. Read and follow all warnings and cautions. Alarm silence touch key Menu touch key Normal screen touch key

Left turn Selector to decrease value Right turn Selector to increase value Rotate Selector to change value Push Selector to confirm selection (ENTER)

AC line supply active +

-

Battery: 23 min.

DC supply active Internal battery supply active Nebulizer active Blue frame selection White frame selection

1-4

TM, elisa, CM-922280, rev. 3.03.a

1 Introduction

On (power) Off (power) Earth ground Protective earth ground Equipotential Type B equipment Input (Expiratory port) Output (Inspiratory port) Nebulizer gas supply

10101

Serial data transfer connection This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

0123

Systems with this mark comply with the European Council Directive (93/42/EEC) for Medical Devices when they are used as specified in their Operation and Maintenance Manuals. The “0123” is the certification number of the Notified Body used by the manufacturer’s Quality Systems. Attention, refer to product instructions, EN/IEC 60601-1

TM, elisa, CM-922280, rev. 3.03.a

1-5

1 Introduction

1.4 Abbreviation for in this manual or the equipment Vent. mode VCV a-VCV SIMV - VC BiLevel Dyn-BiLevel PSV CPAP CPAP/PSV APD ASR NEB NIV OCV Endot.tube Trach.tube NB Newborn Pmax Plimit Pinsp PS PEEP Ppeak Pplat Pmean Pmin Ppeep PEEPi Paw Rate Ratesp I:E Ramp PSramp Time window TInsp I E P t

1-6

Ventilation mode Volume constant controlled Ventilation Assisted Volume controlled Ventilation Synchronized Intermittent Controlled Ventilation- volume constant Bi Level pressure controlled ventilation Bi Level pressure controlled, volume guarantee ventilation Pressure Support Ventilation Continuous positive airway pressure CPAP with apnea BiLevel back up ventilation Automatic patient detection Automatic suction routine Nebulizer Non Invasive Ventilation Online oxygen calibration during ventilation Endotracheal tube Tracheal tube Newborn extension (optional) Newborn (optional) Safety pressure, setting Pressure limit, setting Inspiratory pressure, setting Pressure Support pressure, setting Positive End Expiratory Pressure, setting Highest airway pressure, measured within last breath, measured Plateau pressure, measured Mean airway pressure, measured Lowest airway pressure, measured within last breath Positive End Expiratory Pressure, measured Intrinsic positive End Expiratory Pressure, measured Airway pressure in general Total number of breaths per minute, measured and setting Number of spontaneous breaths per minute, measured Inspiratory to Expiratory time ratio, setting Ramp time between lower and upper BiLevel, setting Ramp time between PEEP level and PS pressure level, setting Trigger time window, setting Inspiration time, setting Inspiration time, calculated Expiration time, calculated Inspiratory pause time in % of inspiration time, calculated Time in general

TM, elisa, CM-922280, rev. 3.03.a

1 Introduction

R C Vt TV MV MVsp MVsp % I-Flow Trigg. Byflow PS endflow Flow Fi-O2 O2-I Spiro Loop V/P Loop F/V Ref. loop I O or AC or DC Ref SN Rev. x.nn.p O2 40 … 90 PSI AIR 40 … 90 PSI 24V/3A DC Serial Port

Resistance of breathing system plus patient, measured Compliance of breathing system plus patient, measured Tidal volume, setting Tidal volume, measured Total minute volume, measured Spontaneous minute volume, measured Percentage of spontaneous minute volume in total minute volume, calculated Inspiratory flow, setting Trigger flow required to trigger an assisted breath, setting Bias flow, setting End-of-flow criteria for PS pressure support, setting Flow in general Inspiratory O2 concentration, setting Inspiratory O2 concentration, measured Spirometry function Volume versus Pressure loop Flow versus Volume loop Reference loop On (power), line supply Off (power), line supply Alternating current Direct current Stock number Serial number Software revision number, nn = version, p = patch O2 gas supply input with a pressure range of 40 … 90 PSI AIR gas supply input with a pressure range of 40 … 90 PSI DC supply input with a voltage of 24 V and a max. current of 3 A Connection for serial data transfer

TM, elisa, CM-922280, rev. 3.03.a

1-7

2 Theory of operation

In this section

2.1 General description 2.2 elisa ventilator features 2.2.1 Safety features 2.3 elisa ventilator main assemblies 2.4 Electrical components 2.5 Pneumatic components

TM, elisa, CM-922280, rev. 3.03.a

2-2 2-3 2-3 2-4 2-5 2-12

2-1

2 Theory of operation

2.1 General description The elisa ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator with built-in monitoring capabilities for • Inspired oxygen concentration • Airway pressure • Airway flow • Exhaled volume.

The ventilator is intended to be used: • To ventilate patients, adults and children with 5 kg body weight and up • To ventilate newborn patients with 2 kg body weight and up (optional) • In intensive care, recovery room, intra clinical patient relocation, general ventilation

The ventilator compensates for • System compliance • Inspiratory and expiratory resistance • Leakage

The ventilator allows • Invasive ventilation • Non-invasive ventilation • Nebulizer operation

The ventilator is capable of the following ventilation modes (English name) (language specific name, if different) • VCV, (a-VCV) VCV, CMV • SIMV-VC SIMV/ASB, VACI/AI • Dyn-BiLevel • BiLevel BiLevel/ASB • CPAP/PSV CPAP/AI, CPAP/ASB

2-2

TM, elisa, CM-922280, rev. 3.03.a

2 Theory of operation

2.2 elisa ventilator features • • • • • • •

• •

•

• • • •

2.2.1 Safety features

• • • • • •

TM, elisa, CM-922280, rev. 3.03.a

On-board diagnostic software to ease servicing. Ventilator hardware is tested during the initial power-up system test. PEEP is generated electronically An exhalation valve modulates the patient’s pressure pattern. The exhalation valve assembly is electronically locked and can be autoclaved. Double stage inspiration valves per gas modulate the patient’s flow pattern. Sensors in the breathing circuit are used to control and monitor patient ventilation and measure inspired oxygen concentration. User settings and microprocessor calculations control breathing patterns. Main engine RS 232 serial digital communication port connects to and communicates with external devices, using the Ohmeda Com 1.0 and Com 1.3 protocol. Front panel RS 232 serial digital communication port connects to and communicates with external devices, such as: • PC or Laptop for downloading trend and event data • Additional hardware components for future options Configuration screen to customize elisa to customer needs Multilanguage onboard software Touch screen capability Optionalization by serialized codes

Dual redundant airway overpressure protection Electronically controlled (active) overpressure protection linked to Pmax. Passive overpressure relief valve, set at fixed value (75 cmH2O) Sub atmospheric pressure relief valve (free breathing valve) Single gas operation capability Back-up battery supply for minimum 30 minutes operation

2-3

2 Theory of operation

2.3 elisa ventilator main assemblies The elisa ventilator has three (3) user accessible main assemblies • • •

The main engine The control panel The expiration valve

The user can separate these three assemblies without using any tools.

Main engine

Control panel

Expiration valve

Standard

2-4

Newborn (optional)

TM, elisa, CM-922280, rev. 3.03.a

2 Theory of operation

2.4 Electrical components The elisa electrical components are described in the following order - Power supply - Main engine - Control panel. On the next page an overview diagram shows all electrical components in one diagram. Most of the components are located on the two main boards - Main board A (control panel) - Main board B (main engine) The following components are not located on the main boards - EC 01, EC 02, EC 03, EC 04, EC 05, EB S10, EB S15 are located within the mains engine’s cabinet - EB S20 is located within the inspiratory connection - EB M00, EB M03, EB M04, EB M08, EB M09, are located within the pneumatic assembly - EB M20, EB M21, EB M22 are located within the nebulizer add on of the pneumatic assembly - EA S05, EA S10, EA S11, EA S12, EA S13 are located within the control panel’s cabinet. - EA S15, EA S16, EA S20 are located within the front panel of the control panel.

TM, elisa, CM-922280, rev. 3.03.a

2-5

2 Theory of operation

2-6

TM, elisa, CM-922280, rev. 3.03.a

2 Theory of operation

AC line supply

Line supply gets via line inlet and fuse SI 0 (EC 01) to the integrated line main switch (EC 02) and from there to the transformer (EC 03). The transformer is designed to be switched between 115 V and 230 V line voltages. For details see section 4. “Change the line voltage”. From the secondary side of the transformer the supply voltage gets to the secondary transformer fuses (SI21/22) and from there to the base supply (EB P14) via a relay switch (EB P01) that is controlled by the power management of micro B.

DC mains supply

The 24 V DC mains supply gets via external DC inlet (EC 04) to the DC line fuses (SI 23) and from there to the base supply (EB P14) via a relay switch (EB P02), controlled by the power management of micro B.

Back up battery supply

The internal battery supply (EC 05) gets via the battery fuse (SI 24) to the base supply (EB P14) via a relay switch (EB P03), controlled by the power management of micro B. To enable the recharging of the battery when necessary, a charger (EB P05) feeds the battery via a fuse (SI 25), when the FET switch (EB P04) disconnects the internal battery from the base supply (EB P14). This way, the battery can be charged by both main supplies, but only when the power management of micro B is active. A deep discharge control (EB P06) cares for the internal battery’s life by prohibiting deep discharging.

Power management

Voltage sensors deliver information to the micro B about the current line voltage (EB P11), the current external DC voltage (EB P12) and the internal battery voltage (EB P13). With the ON/OFF button (EB P00) signal micro B turns system on or off. The micro B manages the three power sources. Line supply and DC main supply are treated as priority mains supply. A ventilation mode can only be started, if one of these two supplies is available. When one of these supply lines is active micro B checks charging status of the internal battery and recharges it if necessary. If the main supply line fails the system turns to supply via internal battery, reduces power consumption by turning off the expiratory valve heater and reducing the screen’s back light brightness.

Power supply priorities

The priority in power supply is defined as - # 1, AC line supply - # 2, DC mains supply - # 3, back up battery supply

TM, elisa, CM-922280, rev. 3.03.a

2-7

2 Theory of operation

On board power supply micro B

Input micro B

2-8

The main board B creates three bus supplies by a +13 V bus (EB P07) via a bus fuse (SI 26), a +15V bus (EB P08) via a bus fuse (SI 27) and a +5 V bus (EB P09) via a bus fuse (SI 28). For analog OP Amps a symmetrical +- 12 V supply is created by EB P08. The alarm system (EB S15), the fan (EB S10) and the control panel are supplied by an OR from both +13V and +15V supply lines. The watchdog (EB S02) controls the +13V (EBP30) and +15V (EBP31) power supply of the safety functions of valve supply etc. In case of a detected malfunction of one or both of the microprocessors the watchdog is able to move the system into a fail-safe status by turning off the bus supplies. The following control sensors talk to the micro B. - EB P11, EB P12, EBP13 - EB M00, EB P00, EB P10 - EB S11, EB S16, EB S20 - EB E11, EB E12 - EB M01, EB M06, EB E01, EB M11 - Data input from micro A is received via the internal serial port (EB S01, EB S03

Output micro B

Micro B talks to the following actors - EB M02, EB M07, EB E02, EB M12, EB S25 - EB M03, EB M08, EB E03, EB E05 - EB M20, EB M21, EB M22 - Data output to micro A is made via the internal serial port (EB S01, EB S03, EB S04) - Data output to a serial communication ports is made via galvanic isolators EB S30, EB P25 und SI 29. - Data output to a nurse call system port is made via galvanic isolators EB S35. - Data output to the watchdog EB204.

Safety

Micro B talks to the watchdog system (EB S02 on PC board B, enabling micro A to react in case of a malfunction of micro B and to allow the watchdog to shut down the system. The watchdog has access to the audible alarm too.

TM, elisa, CM-922280, rev. 3.03.a

2 Theory of operation

On board power supply micro A

The control panel supply voltage with +13V/15V is delivered from the main engine to the panel supply fuse (SI 1), the inverter supply fuse (SI 2) and the alarm supply fuse (SI 4). From SI 1 the +13V/15V (EA P08) is supplied to the +5V supply (EA P01), the 5.0V reference (EA P03) and the alarm LED’s (EA S20). Beyond the fuse SI 3, the 5 V bus EA P02 is distributed to the micro A (EA S00), the DCU Graphics board (EA S12), the VGA display (EA S13), the buttons (EA S15) and the Com wheel (EA S16). From SI 2 the +13V/15V is supplied to the back light inverter (EA S11), that supplies the Display back lights (EA S10). From SI 4 the +13V/15V is supplied to the alarm horn system (EA S05).

Input

The interface components Selector (EA S16) and buttons (EA S15) talk to micro A directly. Data input from micro B is received via the internal serial port (EA S01). The alarm horn control (EA S06) talks to micro A.

Output

Micro A controls output signals to the alarm LED’s (EA S20), the audible alarm (EA S05) the back light inverter (EA S11) and the VGA display via the graphic DCU board (EA S12). Data output to micro B is made via the internal serial port (EA S01).

Safety

Micro A talks to the watchdog system (EA S02) on PC board B, enabling micro B to react in case of a malfunction of micro A. The watchdog has access to the audible alarm, too.

Microprocessor A

The micro A handles all data displayed in the screen, as well as audible and visual alarm indicators within the control panel. The A EPROM is loaded with the language specific issues. The A EEPROM allows storing a “shadow” data set. Disconnection of the control panel during operation will cause the watchdog system to activate and micro B to shut down the system.

Graphic display

Graphic display of data in the VGA screen (EA 9) is performed via a DCU graphic board (EA 8).

Exp. valve heater

To prevent the expiratory flow sensor from condensing water the expiratory valve assembly is heated by the Exp. valve heater (EB E10), supplied by the base supply via the fuse SI 41. The temperature is controlled by micro B and the heater monitor (EB E12).

TM, elisa, CM-922280, rev. 3.03.a

2-9

2 Theory of operation

AIR flow

A pressure sensor for AIR supply (EB M04) tells the micro B about the pressure status of the AIR gas supply. Micro B generates AIR flow by opening the proportional, double staged AIR flow valve (EB M03). The AIR flow sensor (EB M01) measures the generated AIR flow and reports this to micro B. To prevent the AIR flow pressure sensor from drifting, the pressure sensor is periodically zeroed (pneumatically) by use of an offset valve (EB M02).

O2 flow

A pressure sensor for O2 supply (EB M09) tells the micro B about the pressure status of the O2 gas supply. Micro B generates O2 flow by opening the proportional, double staged O2 flow valve (EB M08). The O2 flow sensor (EB M06) measures the generated O2 flow and reports this to micro B. To prevent the O2 flow pressure sensor from drifting, the pressure sensor is periodically zeroed (pneumatically) by use of an offset valve (EB M07).

Exp. Valve (PEEP)

The expiratory valve is a magnetic proportional valve system (EB E03) that is controlled by micro B. Built in the expiratory assembly, the expiratory flow sensor (EB E01) measures the expiratory flow via a stainless steel flow screen and a pressure sensor. To prevent the exp. flow pressure sensor from drifting, the pressure sensor is periodically zeroed (pneumatically) by use of an offset valve (EB E02).

P airway

The airway pressure is measured by the airway pressure sensor (EB M11). To prevent the airway pressure sensor from drifting, the pressure sensor is periodically zeroed (pneumatically) by use of an offset valve (EB M12).

O2 sensor

A fuel cell type O2 sensor (EB S20) measures the inspiratory O2 concentration and reports to micro B. Calibration is semi automatic.

Over pressure relief valve Exp. valve locking motor system Nebulizer valves Watchdog

2-10

A solenoid valve operates as an over pressure relief valve (EB S25) controlled by micro B. The expiration valve locking motor system (EB E05) is controlled by micro B in current limiting and movement direction. The micro B controls the nebulizer valves (EB M20, EB M21 and EB M22) in gas selection between O2 and Air and duration of opening. The watchdog (EB S02) controls both microprocessors A and B and turns off the + 15V WD and +13 V WD supply line, in case of detected malfunction of program or micros. Thus the system is able to shut down in a fail-safe mode.

TM, elisa, CM-922280, rev. 3.03.a

2 Theory of operation

Fan

To avoid possible O2 concentration increase within the housing, caused by leaks, a fan (EB S10) exchanges the gas within the housing. The fan supply is fused by SI11. The fan’s proper operation is monitored by a rotation monitor (EB S11) that reports to the micro B.

Microprocessor B

The micro B handles all controls and sensors, as well as the audible alarm indicator within the main engine and the serial port communication. The B EPROM is loaded with the control software. The B EEPROM allows storing a “shadow” data set.

A and B EEPROM

Both micros store data, such as calibration and “learned” values into the according EEPROM in a “father” and “grandfather” sequence. For safety reasons this sequence is doubled, which results in total in four data store sequences. That is why successfully performing five (5) system test is necessary for rewriting of all storage levels after replacing PC board A or B.

TM, elisa, CM-922280, rev. 3.03.a

2-11

2 Theory of operation

2.5 Pneumatic components The elisa’s pneumatic components are described in the following. On the next page an overview diagram shows all pneumatic components in one diagram. Most of the components are located on the pneumatic assembly. The following components are not located on the pneumatic assembly - EB M01, EB M06, EB M11, EB E01, P05, P15, P22, P28 are located within the PC board B - EB 20, P23 are located within the inspiratory connector - P26, P27, P29 are located within the expiratory valve system

2-12

TM, elisa, CM-922280, rev. 3.03.a

TM, elisa, CM-922280, rev. 3.03.a

270 - 620 kPa

Air input

P 11

O2 input 270 - 620 kPa

P 01

P 32

AIR supply monitor

P 12

P 31

O2 supply monitor

P 02

270 kPa

270 kPa

P 14

Prop. Valves AIR

P 13

P 04

Prop. Valves O2

P 03

P 35

Nebulizer valves

Offset valve

Offset valve

EB M01

Diaphragma AIR

P 16

P 15

EB M06

P 22

Internal tubing

P 07

Sensor O2 flow

Nebulizer connector

P 36

Sensor AIR flow

Diaphragma O2

P 06

P 05

P 33

P 21

Overpress. Valve105 mbar

Underpress. Valve

P 19

O2 Sensor

Insp. Flow connector

P 23

. Valve Electrical Overpress

P 20

EB S20

Offset valve

EB M11

Sensor Pressure

Exp. Flow grid

P 29

EB E01

Sensor Exp. flow

Offset valve

Exp. Valve

P 27

P 28

Pneumatic overview Revision 3.04.X A.Schober 11.05.09

Elisa

Exp. Flow connector

P 26

P 24

Patient flow humidifier

P 25

2 Theory of operation

2-13

2 Theory of operation

Gas supply

Pressure reducer

Pressure reducers for O2 (P 31) and AIR (P 32) regulate the input pressure to a stabilized level of approx. 2.7 bar (38,8 PSI).

Pressure sensor

Pressure sensors for O2 (P 02) and AIR (P 12) monitor the gas pressure input to be above a minimum operating pressure of 1.9 bar (27 PSI).

O2 flow control

Two proportional flow valves control the O2 flow, operating as double staged valves. The first stage valve (P 03) controls the flow between 0 and approx. 43 l/min. Flow demands beyond this level will cause the second stage valve (P 04) to open. A flow screen (P 06) generates a differential pressure from the generated flow, which is measured by the O2 flow pressure sensor (EB M06). The offset valve (P 05) allows zeroing the pressure sensor (pneumatically) for online offset calibration.

AIR flow control

Two proportional flow valves control the AIR flow, operating as double staged valves. The first stage valve (P 13) controls the flow between 0 and approx. 43 L/Min. Flow demands beyond this level will cause the second stage valve (P 14) to open. A flow screen (P 16) generates a differential pressure from the generated flow, which is measured by the AIR flow pressure sensor (EB M01). The offset valve (P 15) allows zeroing the pressure sensor (pneumatically) for online offset calibration.

Airway pressure

The airway pressure within the breathing system is measured by the airway pressure sensor (EB M11). The offset valve (P 22) allows zeroing the pressure sensor (pneumatically) for online offset calibration.

Free breathing valve Overpressure relief valves

O2 sensor

2-14

The gas supply connectors for O2 (P 01) and AIR (P 11) are screw connectors that can be localized to country specific needs (NIST; DISS etc.). Within the gas connectors there are easy to remove sinter filters for each gas, to protect the system from particles.

To avoid sub atmospheric pressure a free breathing valve (P 19) allows ambient air intake in case of a gas supply problem. To avoid airway pressures beyond a level of 105 cmH2O a passive over pressure relief valve (P 20) is provided. To avoid airway pressures beyond an adjustable level, set by the Pmax setting, an active over pressure relief valve (P 21) is provided. The inspiratory O2 sensor (EB S20) is located within the inspiratory port.

TM, elisa, CM-922280, rev. 3.03.a

2 Theory of operation

Patient connection Expiratory valve Expiratory flow

The breathing circuit (P 24) connects the machine via the inspiratory port (P 23) and the expiratory port (P 26) to the patient. The airway pressure within the system is controlled by the expiration pressure valve (P 27). A flow screen (P 29) is built into the expiratory valve assembly and generates a differential pressure from the generated flow, which is measured by the Exp. flow pressure sensor (EB E01. The offset valve (P 28) allows zeroing the pressure sensor (pneumatically) for online offset calibration. The second port of the differential pressure is ambient.

TM, elisa, CM-922280, rev. 3.03.a

2-15

3 Post-service Checkout

In this section

TM, elisa, CM-922280, rev. 3.03.a

3.1 Post-service checkout

3-2

3-1

3 Post service check out

3.1 Post-service checkout After servicing the elisa CC ventilator, perform the following test sequence: • • • •

Power-up test (section 4.1.1) O2 sensor calibration (section 4.7.1) System test (section 4.1.2) Test lung test (section 4.2)

WARNING You must perform all post-service checks after maintenance or service of the elisa CC ventilator. Failure to do so may result in patient injury. WARNING All components and accessories must be connected correctly. All hoses and cables must be properly connected before returning the ventilator to clinical use. Failure to do so may result in patient injury.

After servicing the elisa CC ventilator, perform a device safety check and record the results in a protocol. A proposal for a elisa device safety check protocol is attached on the following page.

3-2

TM, elisa, CM-922280, rev. 3.03.a

3 Post service check out

elisa

Device Safety Testing Protocol

Maintenance check every 12 months

Product description:

CC Ventilator S/N: SW:

HW:

OPT:

Location:

Specs not fulfilled ID/INV.-No.:

Specs fulfilled

Remarks/ measured values

1 Outside appearance 1.1 Housing, marking and buttons without damage 1.2 Power cord and appliance inlet without damage 1.3 O2 and Air hoses without damage 1.4 Expiration valve assembly without damage, flow screen clean 1.5 Accessories, rubber and silicone parts without damage 2 Functional tests (for details refer to the current TM) 2.1 Power up and System test shall be performed without error message 2.2 Perform O2-Sensor calibration 2.3 Service mode values are within the specified ranges 2.4 Perform test lung test according to TM section 4.2 2.5 Perform Service mode check according to TM section 4.4 2.6 Verify measured O2- (O2-I) 2.7 Verify gas failure alarm for O2 and Air 2.8 Verify line power failure alarm and proper function of back up supply 2.9 Verify battery condition according to TM 3 Test of electrical safety 3.1 Protective earth resistance

< 0.2 Ω

Value:

3.2 Enclosure leakage current

< 0.1 mA

Value:

3.3 Earth leakage current

< 0.5 mA

Value:

3.4 Insulation resistance

>2MΩ

Value:

3.5 Verify line power supply fuse to match with selected voltage Remarks:

Recharge back up battery after test !!

Device meets requirements Ser. No.:

Test equipment used:

Repair required Test facility:

Date:

Tester:

TM, elisa, CM-922280, rev. 3.03.a

3-3

3 Post service check out

3-4

TM, elisa, CM-922280, rev. 3.03.a

4 Tests and Calibration

In this section

4.1 Self tests 4.1.1 Power-up test 4.1.2 System test 4.1.3 In-operation test 4.2 Test lung test 4.3 Service mode 4.4 Service mode check 4.5 Software and hardware revision 4.6 Ventilator “on-time” 4.7 Calibrations 4.7.1 O2 sensor calibration 4.7.2 Location of calibration points 4.7.3 AIR flow calibration 4.7.4 O2 flow calibration 4.7.5 Expiratory flow sensor calibration 4.7.6 Airway pressure sensor calibration 4.7.7 Overpressure relief valve calibration 4.8 Battery test 4.9 Free breathing valve test 4.10 Diagnostic test 4.11 Eventlog and trend download (service log)

TM, elisa, CM-922280, rev. 3.03.a

4-2 4-2 4-3 4-6 4-7 4-10 4-12 4-14 4-15 4-16 4-17 4-19 4-20 4-22 4-24 4-28 4-30 4-32 4-34 4-35 4-37

4-1

4 Test and calibration

4.1 Self tests The elisa CC ventilator software includes self tests that determine if the operating software is functioning properly and if the electronic and pneumatic circuits are functional. The self test includes: • Power-up test • System test • In-operation test

4.1.1 Power-up test

The power-up test is started automatically when the system is turned ON and takes at least 7 sec. The remaining test time counts down in the screen. During this power-up test, elisa will check proper function of • • • • • • • • • • •

Microprocessor A and B Watchdog RAM and ROM Matching software versions in EPROM A and B External power supply, AC and DC (if applicable) Internal battery back-up Fan Heater Expiration valve locking system Audible alarm system Back up battery capacity

If a malfunction is identified during this power up test, the corresponding message appears in the screen, including the according failure code. For details of error messages refer to section 5.3.1 “Messages during power up test”.

4-2

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

4.1.2 System test

After having passed the power-up test, the elisa ventilator prompts with a short audible sound and moves to the “Start system test” screen: Connect the elisa ventilator to a breathing circuit and seal the open end of the Y-piece by pushing it onto the sealer located on the expiratory valve block. Select the type of patient, appropriate to the breathing circuit attached. The system test parameter will vary with the patient type selected to match the breathing circuit’s specifications.

Note

Push the Selector to start the system test. This system test takes at least 45 sec. The remaining test time counts down in the screen. During the system test, the system will check proper function of: • O2 gas supply • O2 flow valves • O2 flow sensor • AIR gas supply • AIR flow valves • AIR flow sensor • Nebulizer gas supply • Pressure sensors • Expiration valve • Safety valves • Exp. flow sensor • O2 sensor • Back up battery capacity

TM, elisa, CM-922280, rev. 3.03.a

4-3

4 Test and calibration

If a malfunction is identified during this system test, the corresponding message appears in the screen, including the according failure code. For details of error messages refer to section 5.3.2 “Messages during system test”. After having passed the system test, the system prompts the user to open the Y-piece, to allow testing for inspiratory resistance. Disconnect the Y-piece from the sealer. The system will recognize opening the Y- piece automatically and then proceeds with the test. After calculating the inspiratory resistance, the elisa CC ventilator will display the measured data in the screen.

4-4

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

Special note

To interpret deviation of measured data, be aware that: • Values for compliance, resistance and leakage depend upon the breathing circuit used. • The compliance and leakage values represent the entire system (breathing circuit, nebulizer (if applicable) and ventilator). • The resistance value represents the inspiratory resistance of breathing circuit and ventilator up to the y-piece. • Filters and HME may significantly increase the resistance values. • Other breathing circuit designs, such as co-axial systems, may significantly increase the resistance values. The nebulizer test will be performed every time, though the system detects automatically, if a nebulizer is connected to the breathing circuit or not. • If so, the particular nebulizer flow of this type of jet nebulizer is measured, displayed and stored within the EEPROM. • If not, the nebulizer flow test is bypassed and the last measured flow data (stored in the EEPROM) is used for compensation, if the user activates the nebulizer function later. Because of this measurement capability elisa is able to learn the particular jet nebulizer type, used by this user or hospital.

4.1.3 In-operation test

During operation the elisa CC Ventilator continuously checks the following safety relevant functions and parameters: • Inspiratory flow sensors • Expiratory flow sensor • Inspiratory pressure sensor • O2 sensor • AIR gas supply • O2 gas supply • Line power supply • Battery charging status • Internal power supply • Fan • Heater • Buttons and Selector • Microprocessor A and B • Watchdog • Checksums of all safety relevant data If a malfunction is identified, the system will display alarms or messages on the screen. For details of error messages refer to section 5.3.4 “Messages during operation”.

TM, elisa, CM-922280, rev. 3.03.a

4-5

4 Test and calibration

4.2 Test lung test The Test lung test is used to verify the overall functionality of the ventilator and to observe the results of the continuous in-operation tests. The power-up test and the system test of the elisa CC ventilator verify all safety relevant functions. Perform the power-up test and the system test with a standard disposable breathing circuit with: • 22 mm corrugated dual lumen tube • 70” length At the end of the system test 1. Connect the test lung (ST 3) to the Y-piece. 2. Select patient type “Adult”. 3. Push the Selector or the button to start ventilation. The following screen will appear with the “Adult” default settings:

Test lung graphics

4-6

The graphical data will vary with the breathing circuit and test lung used. Verify that the quality of the graphics is comparable to that shown on the screen above:

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

Default ventilator settings

Default alarm settings

Test lung alarm

Verify the following ventilator settings: • Ventilation mode = BiLevel • Patient type = Adult • Soft key FiO2 = 50 % • Soft key Rate = 10 /min • Soft key I:E = 1 : 2 • Soft key Ramp = 0.2sec • Soft key P-Insp. = 10 cm H2O • Soft key PEEP = 3 cm H2O • Soft key PS = 5 cm H2O • Soft key Trigg. = 6.0 L/Min • Parameter menu PS Ramp = 0.2sec • Parameter menu ByFlow = 3.0 L/Min • Parameter menu Time window = 60% • Parameter menu PS endflow = 25% • Parameter menu Buzzer = 100% • Parameter menu Brightness = 100%

Verify the following alarm settings (red figures) • Alarm limits MV-E max = 12.0 L • Alarm limits MV-E min = 2.5 L • Alarm limits Leakage = 25 % • Alarm limits Pmax =23 cmH2O • Alarm limits Apn.del. = 20 sec • Alarm limits Ratemax = 40 /Min • Alarm limits Ratemin = 8 /Min • Patient data O2-Imax = 55 % • Patient data O2-Imin = 45 % Using the default ventilator and alarm settings will automatically cause an MVmin alarm. Thus, the visual and audible alarm system will be checked.

TM, elisa, CM-922280, rev. 3.03.a

4-7

4 Test and calibration

Test lung numeric data

Test lung test mode change

Note

4-8

The measured data will vary with the breathing circuit and test lung used. Verify the data to be in the following range of values: • MV-E = 1.5 to 2.5 L • TV-E = 130 to 230 mL • Ppeak = 12 to 15 cmH2O • Pmin = 2 to 5 cmH2Or • O2-I = 45 – 55 % • Rate = 9 – 11 /Min To verify proper mode changing and volume accuracy: 1. Note the measured tidal volume (TV) in Bi Level mode. 2. Change the ventilation mode to VCV. 3. Verify the noted tidal volume (TV) to be the set VT in VCV. 4. Allow the ventilator to cycle for five (5) breaths to stabilize. 5. Verify that the quality of the graphics is comparable to that shown on the screen below. 6. Verify that averaged measured tidal volume (TV) is within the tolerance: TV = VT ± (15 ml + 10%). This software revision has BTPS correction. Using a test lung will cause a constant deviation of the measured volume of –2 %. To ease servicing this BTPS correction is not active when in service mode.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

4.3 Service mode The Service Mode is used to test or troubleshoot the major components of the elisa CC ventilator. For safety reasons the service mode is not accessible during the regular operation mode. The service mode is only accessible during and at the end of the power-up test or the system test. Note

Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature. No repair should ever be undertaken or attempted by anyone not having such qualifications. To enter the service mode, push the following sequence of buttons within a time frame of 1 second: 1. ”Adult” left side 2. “Adult” right side 3. “Selector”.

1

TM, elisa, CM-922280, rev. 3.03.a

2

3

4-9

4 Test and calibration

The system will prompt with the following service screen:

Note

Pushing the “EXIT” button returns the system to normal operation. Software revision 3.nn.p has BTPS correction. To ease servicing this BTPS correction is not active when in service mode. The service mode allows verifying the proper operation of the following functions: 1. Pat. Pressure = airway pressure measurement 2. Exp. flow = expiratory flow measurement a. Exp. Flow Adu = Silver exp. Valve detected at the last system test b. Exp. Flow Nbo = Blue (NB) exp. Valve detected at the last system test 3. Air flow = inspiratory AIR flow setting a. Air flow ON = AIR supply pressure OK b. Air flow OFF = Air supply pressure below 2.2 bar (32 PSI) 4. O2 flow = inspiratory O2 flow setting a. O2 flow ON = O2 supply pressure OK b. O2 flow OFF = O2 supply pressure below 2.2 bar (32 PSI) 5. O2 concentr. = inspiratory O2 concentration measurement.

4-10

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

The service mode allows verifying the following internal values of the system: 6. Line voltage = main bus supply voltage a. Line voltage AC = AC line supply detected b. Line voltage DC = DC line supply detected 7. Panel voltage = control panel supply voltage 8. Valve voltage = valve supply voltage 9. Battery voltage = internal back-up battery voltage 10. Controller A/B = microprocessor A/B supply voltage 11. Heater power = expiratory valve heater power dissipation 12. Temper. I/E = Inspiratory / expiratory temperature. The service mode allows verifying of proper operation of the expiratory valve locking mechanism. 13. Open = unlock the expiratory valve assembly 14. Close = lock the expiratory valve assembly 15. Drawer = detected status of locking mechanism a. Drawer< - -> = exp. valve assembly removed b. Drawer OK = exp. valve assembly position for lock in properly detected The service mode allows verifying of proper operation of the Nebulizer. 16. Nebul. OFF = turn nebulizer supply off 17. Nebul. ON = turn nebulizer supply on The service mode allows the following calibration to be initialized: 18. O2 cal = O2 sensor calibration. The service mode displays the following elapsed times: 19. Power-on time = total time, device was supplied with mains supply. 20. Operation time = total time, device was in a ventilation mode. The service mode displays the following PEEP valve data (Exp. valve): 21. G = gain value 22. GR = gain value corrected 23. O = offset value 24. OR = offset value corrected 25. K = correction factor

TM, elisa, CM-922280, rev. 3.03.a

4-11

4 Test and calibration

4.4 Service mode check To identify possible malfunctions displayed as a result of the system test, the following sequence should be used to verify proper gas supply and operation of the inspiratory and expiratory valves. 1. Ensure proper O2, AIR and line supplies are connected before turning ON the system. 2. Wait for the power-up test to complete, and then start the service mode according to 4.3. 3. Check the actual sensor offset values for Pat. Pressure, Exp. flow, AIR flow and O2 flow to be in the “no re-adjustment necessary” range according to section 9.9 “Sensor data ranges”. 4. Connect the inspiratory and expiratory ports with one tube. 5. Verify proper AIR supply pressure and proper function of the AIR pressure switch by AIR flow “ON”. 6. Verify proper AIR flow function by selecting “AIR” and “x 10” and increasing the flow by use of the Selector. 7. Use the Selector to verify that the AIR flow can be returned to zero. 8. Verify proper O2 supply pressure and proper function of the O2 pressure switch by O2 flow “ON”. 9. Verify proper O2 flow function by selecting “O2” and “x 10” and increasing the flow by using the Selector. 10. Use the Selector to verify that the O2 flow can be returned to zero. 11. Verify proper expiratory flow function by comparing the data displayed with the set O2 flow. 12. Select “AIR”, “x 1” and adjust the Selector for an AIR flow of 20 L/Min. 13. Verify proper Airway pressure function by selecting “Pressure” and increasing the pressure setting by use of the Selector. 14. Verify proper O2 concentration while changing Air and O2 flows.

4-12

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

4.5 Software and hardware revision The elisa CC Ventilator’s software is stored in two (2) independent EPROM: • The A EPROM is located on the control panel board (PC board A) • The B EPROM is located on the main board (PC board B). Note

Both EPROM’s must have the same revision level. During the power-up test, the system compares the software revisions in both EPROM. If they do not match, an error message is displayed in the message box. In normal operation mode during power-up and system test the current software and hardware revision is displayed at the top left in the screen. See chapter 1.1.1. In service mode the current software and hardware revision is displayed at the top left of the service menu.

The software revision code “3.nn.p” identifies: - 3. = elisa - nn. = current base software release - p = current patch number of software release (bug fixing level) The hardware revision code “o / r” identifies: - o = front panel hardware revision - r = main engine hardware revision.

TM, elisa, CM-922280, rev. 3.03.a

4-13

4 Test and calibration

4.6 Ventilator “on-time” The elisa CC ventilator’s software stores two “on times”. • Power-on time • Operation time. The power-on time recognizes the total time that the system is connected to line power supply AND is switched ON, no matter in what mode. The operation time only counts the time in total, the system is in a (any) ventilation mode. Both time information are displayed in the Service mode screen.

4-14

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

4.7 Calibrations In the elisa CC Ventilator the following components may be calibrated during service: 1. O2 concentration sensor 2. AIR flow sensor 3. O2 flow sensor 4. Expiratory flow sensor 5. Airway pressure sensor 6. Battery charging end voltage. These procedures may be performed in any order. However, the procedures are presented in a logical sequence to minimize the amount of disassembly and reassembly required. This sequence also ensures best matching of inspiratory and expiratory flow and volume data. When performing the O2 calibration you do not need to open the system’s housing. For all other calibrations open the main engine housing first, according to section 7.2.4. Important note

The expiratory flow sensor calibration is performed anytime, the system test is performed. That replaces the routine calibration of the expiratory flow sensor. Only in case of a B-Board change (requiring a basic calibration of the system), or if the expiratory flow sensor has problematic identified, a re-calibration procedure necessary.

Important note

Rated values may vary with software revisions.

Important note

Always allow the elisa to warm up for at least 15 minutes prior to any calibration procedure.

BTPS correction note

All software revisions have BTPS correction in operation mode. To ease servicing this BTPS correction is not active when in service mode.

AIR – O2 mixing

To ensure consistent O2 – AIR mixture over a variety of flow settings always calibrate both, the AIR flow sensor and the O2 flow sensor, when having the need to calibrate one of the two flow sensor lines.

TM, elisa, CM-922280, rev. 3.03.a

4-15

4 Test and calibration

4.7.1 O2 sensor calibration

Special notice

The elisa CC Ventilator performs an automatic calibration of the O2 sensor during the O2 calibration routine. This routine requires an O2 gas supply. The calibration routine performs the 100% (gain) calibration only. To ensure proper gas mixture at the O2 sensor, connect a tube to the inspiratory connector. There are two ways to access the O2 calibration routine: • In the user system test menu. • In the service mode. The calibration routines are identical.

Access in user system test menu

Push the menu button after completion of the power-up test to access the user system test menu. The system will prompt with the following screen: 1. Use the Selector to select “Calibrate O2 sensor” 2. Push the Selector to confirm selection. 3. O2 calibration starts

Access in service mode

4-16

From the service mode the O2 calibration is started by pushing the “O2cal” button.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

O2 calibration procedure

The procedure starts with the following screen: This calibration procedure takes at least 60 seconds. The remaining test time counts down on the screen. During this time the measured concentration is displayed. If any malfunction is identified during this procedure, the corresponding message appears in the message box area. For details of error messages refer to section 5.3.3 “Messages during O2 sensor calibration”. Pushing the “Stop” button stops the calibration procedure and retains the former calibration data. The system returns to the menu it started from.

Special notice

After performing an O2 calibration, flush the system with AIR. This will avoid possible misinterpretations of the FiO2 measurement, caused by high concentrations of O2 within the internal tubes and pneumatic components. The calibration for

4.7.2 Location of calibration points

1. 2. 3. 4. 5.

AIR flow sensor (AIR O2 flow sensor (O2) Airway pressure (Paw) Expiratory flow sensor (Exp.) Battery changing end voltage (Ubat)

is performed with the main engine opened. The calibration adjustments are located on PC board B. Removing the internal battery makes the calibration points easy to reach. The calibration points for the pressure/flow transducers are located right above the corresponding pressure transducer and always with the offset to the left and the gain to the right. The calibration point for the charger voltage is located below the relays.

TM, elisa, CM-922280, rev. 3.03.a

4-17

4 Test and calibration

4.7.3 AIR flow calibration

The calibration points are circled on the following sketch: The AIR flow calibration is divided into two parts • •

Offset calibration

The offset calibration The gain calibration

The Offset calibration is performed with the use of the service mode only. The gain calibration is performed by using an external flow measurement device. To calibrate the AIR flow sensor follow this preparation sequence: 1. Ensure that the system is turned OFF and line power is disconnected. 2. Open main engine according to section 7.2.4. 3. Remove internal back-up battery according to section 7.9.1. 4. Re-insert exp. valve assembly. 5. Connect line power and gas supply and turn ON the system. 6. Verify that the system performs the power-up test.

4-18

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

Gain calibration

7. Start the service mode according to section 4.3. 8. Use a 10” 22 mm tube ACTUAL RATED to connect the external Pat.Pressure 0 mbar 0 mbar Exp.flow 513 Digit 500 Digit flow measurement 254 Digit AIR flow ON 250 Digit 251 Digit O2 flow ON device to the inspiratory 250 Digit connection. 9. Verify that the direction of flow is correct for the measurement device. 10. Turn on the flow measurement device and let it warm up according to manufacturers instructions 11. Select AIR for the measured gas on the flow measurement device. 12. Select the “AIR” and “x 1” button. 13. Verify the flow to be 0 L/Min on the external flow measurement device. 14. Check the “AIR flow” “Actual” to be at the “Rated” value ± 50 digits. 15. If not, readjust the “Zero” for the AIR flow sensor with R 316 on the main board B to read “Rated” value ± 10 digits. 16. Use the Selector to increase the AIR flow to read 30.0 L/min on the “AIR flow” “Rated”. The units in the service menu change from Digits to L/Min. 17. Verify that the external flow meter device reads 30 ± 1.5L/Min. 18. If not readjust the “Gain” for the AIR flow sensor with R 313 on the main board to read 30 ± 1.5 L/Min. 19. Use the Selector to decrease the AIR flow to read 0 L/min. 20. Check the “AIR flow” “Actual” to be at the “Rated” value ± 50 digits. 21. If not, readjust the “Zero” for the AIR flow sensor with R 316 on the main board to read the “rated” value ± 10 digits. 22. Use the Selector to increase the AIR flow to read 10.0 L/min on the “AIR flow” “Rated” The units in the service menu change from Digits to L/Min”. ACTUAL RATED 23. Verify that the external Pat.Pressure 0 mbar 0 mbar flow meter device reads Exp.flow 513 Digit 500 Digit 350 Digit AIR flow ON 10 L/Min 10 ± 0.5 L/Min. 251 Digit O2 flow ON 250 Digit 24. If not, go back to step 16. Change setting for 30 l/min within the tolerance in the desired direction to match the 10 ± 0.5 L/Min.

TM, elisa, CM-922280, rev. 3.03.a

4-19

4 Test and calibration 25. Use the Selector to increase the AIR flow to read 60.0 L/Min on the “AIR flow” “Rated”. 26. Verify that the external flow meter device reads 60 ± 3.0 L/Min. 27. If not, go back to step 16. Change setting for 30 L/Min within the tolerance in the desired direction to match the 60 ± 3.0 L/Min. 28. If the AIR flow cannot be calibrated within the three flow specifications, check AIR gas filter. Note

4.7.4 O2 flow calibration

Best results for linearity match with all three test flows are received when the “Gain” is adjusted initially at 30 L/Min value in step 16. to read 29.8 L/Min on the external flow meter device.

The O2 flow calibration is divided into two parts • •

Offset calibration

The offset calibration The gain calibration

The Offset calibration can only be performed in service mode. The gain calibration is performed by using an external flow measurement device. To calibrate the O2 flow sensor follow this preparation sequence: 1.

Ensure that the system is turned OFF and line power is disconnected. 2. Open main engine according to section 7.2.4. 3. Remove internal back-up battery according to section 7.9.1. 4. Re-insert exp. valve assembly. 5. Connect line power and gas supply and turn ON the system. 6. Verify that the system ACTUAL RATED performs the powerPat.Pressure 0 mbar 0 mbar up test. Exp.flow 513 Digit 500 Digit 254 Digit AIR flow ON 250 Digit 7. Start the service 251 Digit O2 flow ON 250 Digit mode according to section 4.3. 8. Use a 10” 22 mm tube to connect the external flow measurement device to the inspiratory connection. 9. Verify that the direction of flow is correct for the measurement device. 10. Turn on the flow measurement device and let it warm up according to manufacturers instructions. 11. Select O2 for the measured gas on the flow measurement device.

4-20

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

Gain correction

Note

12. Select the “O2” and “x 1” button. 13. Verify the flow to be 0 L/Min on the external flow measurement device. 14. Check the “O2 flow” “Actual” to be at the “Rated” value ± 50 digits. 15. If not, readjust the “Zero” for the O2 flow sensor with R 306 on the main board B to read the “Rated” value ± 10 digits. 16. Use the Selector to increase the O2 flow to read 30.0 L/Min on the “O2 flow” “Rated” The units in the service menu change from Digits to L/Min. 17. Verify that the external flow meter device reads 30 ± 1.5 L/Min. 18. If not, readjust the “Gain” for the O2 flow sensor with R 303 on the main board to read 30 ± 1.5 L/Min. 19. Use the Selector to decrease the O2 flow to read 0 L/Min. 20. Check the “O2 flow” ACTUAL RATED Pat.Pressure 0 mbar “Actual” to be at the 0 mbar Exp.flow 513 Digit 500 Digit “Rated” value ± 50 254 Digit AIR flow ON 250 Digit 351 Digit O2 flow ON 10 L/Min digits. 21. If not, readjust the “Zero” for the O2 flow sensor with R 306 on the main board to read the “Rated” value ± 10 digits. 22. Use the Selector to increase the O2 flow to read 10.0 L/Min on the “O2 flow” “Rated”. 23. Verify that the external flow meter device reads 10 ± 0.5 L/Min. 24. If not, go back to step 16. Change setting for 30 L/Min within the tolerance in the desired direction to match the 10 ± 0.5 L/Min. 25. Use the Selector to increase the O2 flow to read 60.0 L/Min on the “O2 flow” “Rated”. 26. Verify that the external flow meter device reads 60 ± 3.0 L/Min. 27. If not, go back to step 16. Change setting for 30 l/min within the tolerance in the desired direction to match the 60± 3.0 L/Min. 28. If the O2 flow cannot be calibrated within the three flow specifications, check O2 gas filter. Best results for linearity match with all three test flows are received when the “Gain” is adjusted initially at 30 L/Min value of step 16. to read 29.8 L/Min on the external flow meter device.

TM, elisa, CM-922280, rev. 3.03.a

4-21

4 Test and calibration

4.7.5 Expiratory flow sensor calibration Offset correction

The Expiratory flow sensor calibration is divided into two parts • •

The offset calibration The gain calibration

The Offset calibration can only be performed in service mode. The gain calibration is performed by using the calibrated AIR flow system (refer to section 4.7.3.). To calibrate the expiratory flow sensor follow this preparation sequence: 1.

Ensure that the system is turned OFF and line power is disconnected. 2. Open main engine according to section 7.2.4. 3. Remove internal back-up battery according to section 7.9.1. 4. Reinsert exp. valve ACTUAL RATED assembly. Pat.Pressure 0 mbar 0 mbar Exp.flow 513 Digit 500 Digit 5. Connect line power 254 Digit AIR flow ON 250 Digit 251 Digit O2 flow ON 250 Digit and gas supply and turn ON the system. 6. Verify that the system performs the power-up test. 7. Start the service mode according to section 4.3. 8. Use a 10” 22 mm tube to connect the inspiratory and expiratory ports. 9. Select the “AIR” and “x 1” button. 10. Verify the flow to be 0 L/Min on the “AIR flow” ” Actual” line. 11. Check the “Exp. flow” “Actual” to be at the “Rated” value ± 100 digits. 12. If not, readjust the “Zero” for the Exp. flow sensor with R 336 on the main board to read the “Rated” value ± 10 digits.

Note

4-22

Verify the AIR flow has been calibrated according to 4.7.3 before performing the expiratory flow gain calibration.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

Gain correction

Note

13. Leave the expiration valve assembly inserted in the elisa. Unscrew the flow screen retainer in the exp. valve assembly. For flow retainer with a visible slot use the stainless steel plate of the PEEP valve to unscrew. For other flow retainer use the inspiration connection nut from the tool kit ST4. 14. Carefully remove the flow screen and store it in a safe place so that it can be re-installed in an undamaged condition for regular operation. 15. For calibration purpose insert the “Service” Flow screen ST5 (zero tolerance), p/n M1063267 and screw flow screen retainer. If “Service” Flow screen ST5 is not available, reference step 35 for calibration procedure using existing flow screen. 16. Select the “Press” button and use the Selector to increase the “Pat. Pressure” “Rated“ to read to 10 cmH2O. 17. Select the “AIR” and “x1” button. 18. Use the Selector to increase the “AIR flow” “Rated” to read 30 L/Min. The units in the ACTUAL RATED service menu change Pat.Pressure 0 mbar 0 mbar from Digits to L/Min. Exp.flow 29,8 l/min 500 Digit 730 Digit AIR flow ON 30 l/min 19. Check the “Exp. flow” 251 Digit O2 flow ON 250 Digit “Actual” to read “Cal30” ± 0.5 L/Min. 20. If not, readjust the “Gain” for the exp. flow sensor with R 333 on the main board to read “Cal30” ± 0.5 L/Min. 21. Use the Selector to decrease the Exp. flow to read 0 L/Min. 22. Check the “Exp. flow” “Actual” to be at the “Rated” value ± 100 digits. 23. If not, readjust the “Zero” for the Exp. flow sensor with R 336 on the main board to read the “Rated” value ± 10 digits. 24. Use the Selector to increase the AIR flow to read 10 L/Min on the “AIR flow” “rated” line.

TM, elisa, CM-922280, rev. 3.03.a

4-23

4 Test and calibration

25. Check the “Exp. flow” “Actual” to read “Cal10” ± 0.5 L/Min. 26. If not, go back to step 18. Change setting for 30 L/Min within the tolerance in the desired direction to match the “Cal10” ± 0.5 L/Min. 27. Use the Selector to increase the AIR flow to read 60 L/Min on the “AIR flow” “Rated” line. 28. Check the “Exp. flow” “Actual” to read “Cal60” ± 3.0 L/Min. 29. If not, go back to step 18. Change setting for 30 L/Min within the tolerance in the desired direction to match the “Cal60” ± 3.0 L/Min. 30. When all three values match, calibration is performed properly. 31. Now unscrew flow screen retainer in the exp. valve assembly. For flow retainer with a visible slot use the stainless steel plate of the PEEP valve to unscrew. For other flow retainer use the inspiration connection nut from the tool kit ST4. 32. Remove “Service” Flow screen and insert the original flow screen (customer flow screen). 33. Screw the flow retainer. 34. Perform a system test to verify proper operation of the valve assembly. Note

Calibration without “Service” flow screen ST5 Offset correction Gain correction

4-24

For elisa NB (newborn extension) use always the silver Adult / Pediatric (standard) expiration valve with the according “Service “ flow screen to perform expiration flow sensor calibration In case expiration flow sensor calibration must be performed without a “service” flow screen, follow this sequence

35. Perform offset calibration as described in steps 1 to 12 in chapter 4.7.5. 36. For the gain correction without using a “service” flow screen you need to know the current flow screen’s tolerance. This tolerance is visible on the rim of the flow screen. 37. For gain correction start with step 13 in chapter 4.7.5.and remove the built-in flow screen according to step 14. 38. Read and note the “Insp” % tolerance in the flow screen correction table below. 39. Insert the flow screen again into the expiration valve assembly and screw the flow screen retainer. 40. Perform gain correction as described in step 16 to 30 in chapter 4.7.5.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

41. At step 19 use, the new value from the flow screen correction table for step 19 that matches with the noted flow screen tolerance. (Example: Tolerance = + 4.5 %, calibration value for step 19 is 28.7 L/Min) 42. At step 25 use, the new value from the flow screen correction table for step 25 that matches with the noted flow screen tolerance. (Example: Tolerance = + 4.5 %, calibration value for step 25. is 9.6 L/Min) 43. At step 28 use, the new value from the flow screen correction table for step 28 that matches with the noted flow screen tolerance. (Example: Tolerance = + 4.5 %, calibration value for step 28 is 57.3 L/Min). Flow screen correction data table

Flow screen tolerance “Insp”

New value for step 19.

+ 9.99 % to + 9.00 % + 8,99 % to + 8.00 % + 7.99 % to + 7.00 % + 6.99 % to + 6,00 % + 5.99 % to + 5.00 % + 4.99 % to + 4.00 % + 3.99 % to + 3.00 % + 2.99 % to + 2.00 % + 1.99 % to + 1.00 % + 0.99 % to + 0.50 % ± 0.49 % (Service flow screen) - 0.50 % to – 0.99 % - 1.00 % to – 1.99 % - 2.00 % to – 2.99 % - 3.00 % to – 3.99 % - 4.00 % to – 4.99 % - 5.00 % to – 5.99 % - 6.00 % to – 6.99 % - 7.00 % to – 7.99 % - 8.00 % to – 8.99 % - 9.00 % to – 9.99 %

TM, elisa, CM-922280, rev. 3.03.a

New value for step 28.

27.2 27.5 27.8 28.1 28.4 28.7 28.9 29.3 29.6 29.8 30.0

New value for step 25. 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.9 10.0

30.2 30.5 30.8 31.1 31.4 31.7 32.0 32.3 32.6 32.9

10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.9 11.0

60.3 60.9 61.5 62.1 62.7 63.3 63.9 64.5 65.1 65.7

54.3 54.9 55.5 56.1 56.7 57.3 57.9 58.5 59.1 59.7 60.0

4-25

4 Test and calibration

4.7.6 Airway pressure sensor calibration

The Airway pressure sensor calibration is divided into two parts • •

The offset calibration The gain calibration

The Offset calibration is performed with the use of the service mode only. The gain calibration is performed by using an external pressure measurement device. To calibrate the airway pressure sensor:

Gain correction

4-26

1. Ensure that the system is turned OFF and line power is disconnected 2. Open main engine according to section 7.2.4: 3. Remove internal back-up battery according to section 7.9.1: 4. Re-insert exp. valve assembly: 5. Connect line power and gas supply and turn ON the system: 6. Verify that the system performs the power-up test: 7. Start the service mode according to section 4.3.: 8. Connect the standard breathing system to the inspiratory and expiratory port. Connect a standard 15 male/female Y-piece elbow with a LUER lock gas sample port to the Y-piece: 9. Seal the open end of the Y-piece elbow using the seal port on the exp. valve assembly: 10. Connect the external pressure measurement device to the LUER lock connection of the Y-piece elbow: 11. Turn on the pressure measurement device and let it warm up according to manufacturers instructions: 12. Select the “PRESS” button and verify no flow is activated: 13. Verify the pressure to be 0 cmH2O on the ext. pressure meter. 14. Check the “Pat. Pressure” “Actual” to be at 0 ± 0.5 cmH2O: 15. If not, readjust the “Zero” for the Airway pressure sensor with R326 on the main board to read 0 ± 0.1 cmH2O. 16. Select the “Press” button and use the selector to increase the “Pat. Pressure” “Rated” to read to 60 cmH2O. 17. Select the “AIR” and “x1” button and use the selector to increase the “AIR flow” ”Rated” to read 1 L/min. The units in the service menu change from Digits to L/min. 18. Check the “Pat. Pressure” “Actual” to read the “external pressure measurement device” value ± 0.6 cmH2O.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

19. If not, readjust the “Gain” for the Airway pressure sensor with R323 on the main board to read “external pressure measurement device value” ± 0.6 cmH2O. 20. Reduce the test pressure to 0 cmH2O by reducing the “Patpressure” rated to 0 cmH2O and the AIR flow to 0 L/min. Open the seal at the y-piece. 21. Verify the pressure to be 0 cmH2O on the ext. pressure meter. 22. Check the “Pat. Pressure” “Actual” to be at 0 ± 0.5 cmH2O. 23. If not, readjust the “Zero” for the Airway pressure sensor with R 326 on the main board to read 0 ± 0.1 cmH2O.

4.7.7 Overpressure relief valve calibration

The overpressure relief valve calibration is performed with the use of the service mode. To calibrate the overpressure relief valve: 1. Ensure that the system is turned OFF and line power is disconnected. 2. Open main engine according to section 7.2.4. 3. Re-insert exp. valve assembly. 4. Connect line power and gas supply and turn ON the system. 5. Verify that the system performs the power-up test. 6. Start the service mode according to section 4.3. 7. Connect one tube to the inspiratory port. 8. Seal the open end of the tube with a 22 mm stopper plug. 9. Select the “Air” and “x 1” button. 10. Use the Selector to increase the AIR flow to read 20 L/Min.

Note

Increase flow slowly by small steps to avoid oscillation of the over pressure relief valve. 11. Watch the “Pat. Pressure” increase and stabilize at a certain pressure level. 12. Check the “Pat. Pressure” “Actual” to be at 105 ± 2 cmH2O. 13. If not, readjust the overpressure relief valve by turning the valve cap until “Pat. Pressure” “Actual“ reads 75 ± 2 cmH2O. Turning clockwise increases pressure, counterclockwise lowers pressure.

TM, elisa, CM-922280, rev. 3.03.a

4-27

4 Test and calibration

4.8 Battery test The elisa internal back up battery has an expected life time of 24 months under standard operation conditions (10 to 35°C). After 24 months this battery needs replacement. Note

When system is operated in extended temperature areas (10 to 40°C), such as burn units, the expected battery life is reduced and battery replacement is recommended every 12 months. If in the meantime battery’s capacity is doubted, perform the following test to verify proper battery capacity. A stop watch is needed. 1. Connect AC line supply to elisa. 2. Turn ON elisa and wait for the power up test to terminate. 3. Set up elisa with a breathing system and perform the system test. 4. Start ventilation in default settings (Adult, BiLevel) with a test lung (according to section 4.2) connected. 5. elisa shows the operational screen. Check the battery status line to be OFF as an indicator for a fully charged battery. If battery status line is active wait until the battery is fully charged and the battery status indicator is OFF. 6. Turn OFF the AC line supply main switch to disconnect AC supply and start the stop watch. 7. elisa operates now on battery only. Be aware that during operation and discharging the battery a high priority alarm for an empty battery can appear. 8. Wait until either. a. operation time is > 30 min b. or a permanent alarm indicates a watchdog system failure “0036” “battery empty and no line supply” c. or elisa automatically shuts down with a completely discharged battery and then stop the stop swatch. 9. The operation time shown in the stop watch shall exceed 30 minutes. a. If battery operation time is > 30 minutes, the battery is OK and can remain installed within the elisa until scheduled replacement has to take place during standard maintenance. b. If battery operation time is < 30 minutes perform battery refreshing process as described below.

4-28

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

Battery refreshing

A battery with a capacity of less then 30 minutes can be refreshed to gain capacity again by completely discharging and completely recharging. The main aspect in that refreshing process is to empty the battery down to its lowest accepted level, which is controlled by the elisa´s power management, and fully charge afterwards. 10. Perform the discharging and recharging process as described in the battery test procedure above, for three times in a row. 11. After the third charging and discharging process the operation time, measured by the stop watch should exceed 30 minutes. a. If battery operation time is > 30 minutes, the battery is OK and can remain installed within the elisa until scheduled replacement has to take place during standard maintenance (24 months). b. If battery operation time is < 30 minutes battery needs replacement. Please note serial number of the elisa on top of the battery.

Special notice

It is important that the discharging process and the recharging process are not interrupted.

TM, elisa, CM-922280, rev. 3.03.a

4-29

4 Test and calibration

4.9 Free breathing valve test The elisa CC Ventilator allows a spontaneous breathing patient to breath room air in case of a total gas supply fail. In this case the free breathing valve allows draining in room air during inspiration and the PEEP valve allows expiration. To check proper operation of the free breathing valve: 1. 2. 3. 4. 5. 6. 7. 8. 9.

4-30

Turn ON elisa. Wait for the power up test to terminate. Start the service mode according to 4.3. Verify that O2 flow and AIR flow are set to “zero” (no inspiratory flow). Set up elisa with a breathing system. Set up the breathing system with a bacterial filter at Y-piece. Breathe normally through the bacterial filter at the Y-piece. Verify proper room air intake through the free breathing valve. In case of high resistance or blocked free breathing valve replace free breathing valve according to section 7.9.10.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

4.10 Diagnostic tests The elisa CC Ventilator software has diagnostic tests built-in to ease servicing. When in service mode these diagnostic routines are active. Start the service mode and the system will display the following screen:

Pat. Pressure AIR flow ON

O2 flow ON

O2 concentration Line voltage AC

The actual airway pressure is displayed here. The ON / OFF flag behind the AIR flow indicates the status of the pressure switch. The flag is “ON” when an AIR supply pressure is detected with > 1.9 kPa (27 PSI). The actual AIR flow data is displayed here. The ON / OFF flag behind the O2 flow indicates the status of the pressure switch. The flag is “ON” when an O2 supply pressure is detected with > 1.9 kPa (27 PSI). The actual O2 flow data is displayed here. The actual O2 concentration is displayed here. The AC / DC flag behind the line voltage indicates the source of the mains supply. The flag is “AC” when line supply is detected, the flag is “DC” when 24 V DC supply is detected. The line voltage is measured at the base supply line and represents • the secondary transformer voltage, when connected to AC line supply. Accepted voltage range is 19 to 29 V, which represents the following line supply voltages - 98 to 132 VAC at 115 VAC (50-60 Hz) - 198 to 263 VAC at 230 VAC (50-60 Hz) • the external DC voltage, when powered by DC line supply. Accepted voltage range is 22.5 to 28 VDC .

TM, elisa, CM-922280, rev. 3.03.a

4-31

4 Test and calibration

Panel voltage

The panel voltage measures the +13/15V control panel supply. Accepted voltage range is 12.5 to 17.0 V.

Valve voltage

The valve voltage is measured at the main bus 13 V WD (WD = watchdog controlled bus). Accepted voltage range is 11.5 to 15.0 V.

Battery voltage

The battery voltage measures the internal back-up battery voltage. Accepted voltage range is 22.5 to 29 V. Additional data: • • •

Control. A/B

Heater power

Temperature I/E

Drawer ExpValve

4-32

Ubatt > 29.0 V = Battery failure alarm Ubatt < 22.5 V = Battery low alarm Ubatt < 22.0 V = Battery depleted alarm

The controller voltage is measured for each microprocessor, the micro A and micro B supply bus. Accepted voltage range is 4.5 to 5.5 V. The heater power measures the power dissipation of the expiratory flow sensor heating system. Accepted power dissipation is < 12.0 W. The temperature for the inspiratory engine (I) and the expiratory flow sensor (E) is displayed here. Accepted temperature is 5 to 48 °C. “OK” indicates proper locking of the expiratory valve. “< -- >” indicates removed expiratory valve. These data are used for manufacturing QM only.

TM, elisa, CM-922280, rev. 3.03.a

4 Test and calibration

4.11 Event log and trend download (service log) elisa has a built in trend and event log book (service log). This data is stored in a ring buffer and has a maximum capacity of 5,172 positions. In normal use that represents about 2 weeks continuous trend data and about 1,000 event log topics. In case of unclear anomalies or function issues this event log and trend download can help to identify problems. There are two ways to access the event log and trend data. - trend option is available and trend data is retained - trend option is not available or trend data was not retained Trend option available

Important note

Trend option not available

When the option “Trend” is available on this elisa start the system and perform a power up test. To see the event and trend data push the “Retain trend data” button and verify it has confirmed by changing color into green before you start performing a system test. Apply a breathing system and a test lung and go into normal default ventilation operation after system test. Follow UM elisa chapter 6.3.7 Read event and trend data to see the requested information. If the system has been started without activating the “Retain trend data “ button the elisa internal trend viewer has been reset to the current date and time and older data is no longer visible to the user. Internally older data are still stored and available for service purpose. In this case follow the instruction for elisa without trend option. In case no trend option is available or the retain data button has not been activated and elisa internal viewer is reset, the internal service log can be downloaded through the front side serial port at the control panel to a PC or laptop.

TM, elisa, CM-922280, rev. 3.03.a

4-33

4 Test and calibration

The download requires - a service cable P/N BE-126081 to connect elisa and a PC. The Lemosa plug matches the socket at the elisa front panel (lower side), the D-Sub 9 matches a standard serial port of the PC. - a standard Serial-To-USB converter to connect the service cable to a Laptop with USB sockets. The D-Sub 9 plug of the service cable is connected with the serial side of the Serial-To-USB converter, the USB plug connects to the Laptop. - a dedicated software for serial data transfer.

Hardware connection

To download trend data from elisa service log to a Laptop or PC follow this instruction: 1. Turn OFF elisa. 2. Turn OFF PC or laptop 3. Connect the service cable with its Lemosa plug to the elisa serial port at the control panel. 4. Connect the service cable with its D-Sub 9 plug to the serial port of the PC. In case of using a laptop with USB connections only, use a standard Serial-to-USB converter to connect the DSub 9 to the USB connection. 5. Turn ON the PC or Laptop 6. Turn ON the elisa. 7. Wait for the power up test to terminate. 8. For downloading the service log stay either in system test screen mode or move into service mode. Download in operation mode is not enabled. 9. For downloading the service log use the “elisa service log downloader”. For more details refer to Appendix A 1.

WARNING

4-34

Although the front side Lemosa port of the elisa is galvanically isolated and allows connecting PC or laptop, always perform a service log download when no patient is connected and device is not in operation mode.

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting WARNING Post-Service checkout is required after you have completed this section. You must perform Section “3/Post-Service Checkout” after performing maintenance, service or repair. Failure to do so may result in patient injury.

In this section 5.1 Troubleshooting instructions 5.2 Alarms 5.3 Messages 5.3.1 Messages during power-up test 5.3.2 Messages during system test 5.3.3 Messages during O2 sensor calibration 5.3.4 Messages during operation 5.3.5 System shut down messages

TM, elisa, CM-922280, rev. 3.03.a

5-2 5-4 5-11 5-11 5-16 5-27 5-28 5-32

5-1

5 Troubleshooting

5.1 Troubleshooting instructions The elisa CC Ventilator software includes self test capability to identify problems or malfunctions of the system. However, some ventilator problems may not generate any message or alarm, even though the ventilator is not be functioning correctly. The self tests include: • Power-up-test • System test • In-operation test Additional self test capabilities are within the: • O2 sensor calibration User related alarms and messages will be displayed in the user selected language to allow the operator to react, either by correcting the problem or by calling an authorized service specialist. The identified problem, malfunction or advice will be displayed with either an alarm or a message on the screen.

While in power-up test, system test and O2 calibration the messages will appear in the screen, showed above. Be aware that system test messages may appear because of artifacts during the system test sequence. These artifacts could be moving, manipulating and handling of accessories and breathing circuit components while performing the tests. In this case no malfunction of elisa has created the message performing the system test again will allow to pass the system test successfully.

5-2

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

While in operation, the messages will appear in the operation screen.

TM, elisa, CM-922280, rev. 3.03.a

5-3

5 Troubleshooting

5.2 Alarms No Alarm 1 “Pressure high”

Priority High

Set condition In all modes: If Ppeak ≥ Pmax Sequence #2 to follow: If Ppeak > (Pmax + 2 cmH2O)

Action User alarm. Check vent. settings AND check breathing system, PEEP valve for blockage or kinked tubes

2

“Pressure low”

High

User alarm. Check vent. settings AND check breathing system, PEEP valve for leaks AND check LuerLock port covers of HME, HMEF and filters for leaks

3

“Pressure sustained”

High

VCV, SIMV, DynBiLevel mode: If Ppeak < (PPEEP + 2 cmH2O) after 15 sec from start of insp. BiLevel mode: If Ppeak < ((Pinsp + PPEEP) /2 ) – 0.5 cmH2O after 15 sec from start of insp. CPAP mode: If Ppeak < ((PS + PPEEP) /2 ) – 0.5 cmH2O after 15 sec from start of insp. In all modes: If Pairway < -1 cmH2O for more than 0.5 sec In all modes: If Pmin > (PPEEP + 2 cmH2O) within one breath In all modes: If Pairway > (Pset + 5 cmH2O) within 0.5 sec

5-4

User alarm. Check vent. settings AND check breathing system, PEEP valve for blockage or kinked tubes

Reset condition In all modes: Within the following breath If Ppeak< (Pmax–2 cmH2O) and Inspiratory safety valve is closed. VCV, SIMV, DynBiLevel mode: If Ppeak ≥ (PPEEP + 2 cmH2O) within the following breath BiLevel mode: If Ppeak ≥ ((Pinsp + PPEEP) /2) – 0.5 cmH2O within the following breath. CPAP mode: If Ppeak ≥ ((PS + PPEEP) /2) – 0.5 cmH2O within the following breath. And for all modes: If Pairway ≥ 0 cmH2O In all modes: If Pmin < (PPEEP + 2 cmH2O) within the following breath and Inspiratory safety valve is closed

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

No Alarm 4 “Apnea”

Priority Set condition High VCV, SIMV-VC, BiLevel, mode: System open (see messages) for longer than Apnea time

Action User alarm. Check for apnetic patient AND Check breathing system, PEEP valve for leaks CPAP/PSV mode: User alarm. Since the last BiLevel back up expiration no breath is mode is started. detected in set apnea Check for apnetic time patient. or measured rate < 4 bpm

5

“Leakage”

High

In all modes: If measured leakage (((Vinsp-Vexp) / Vinsp) * 100) > set leakage alarm (5% - 95%)

6

“Vt not constant”

High

VCV, SIMV-VC modes: If Ppeak ≥ Plimit And Vt measured ≤ Vt set * 0.8

User alarm. Check leakage alarm setting AND Check breathing system, PEEP valve for leaks User alarm. Check vent. setting AND check breathing system, PEEP valve for blockage or kinked tubes

Dyn-BiLevel mode: If Vt measured ≤ Vt set * 0.8 7

“MV low”

High

8

“MV high”

High

TM, elisa, CM-922280, rev. 3.03.a

In all modes: If calculated MV over 61 seconds or over 10 breaths (which ever is smaller) < set MV limit (0.5 – 50 L/min) In all modes: If calculated MV over 61 seconds or over 10 breaths (which ever is greater) > set MV limit (0.5 – 50 L/min)

User alarm. Check MV min alarm setting AND MV E User alarm. Check MV max alarm setting AND MV E

Reset condition VCV, SIMV-VC, BiLevel, CPAP/PSV mode: Next expiration is detected and Rate > 3 bpm CPAP/PSV mode: Restart CPAP/PSV mode or start any other mode AND next expiration is detected and Rate > 3 bpm. In all modes: If measured leakage ≤ set leakage alarm (5% - 95%) within one breath VCV, SIMV-VC modes: If Ppeak < Plimit AND Vt measured > Vt set x 0.8 at the end of inspiratory time Dyn-BiLevel mode: Vt measured > Vt set x 0.8 at the end of inspiratory time In all modes: If calculated MV > set MV limit (0.5 – 50 L/min)

In all modes: If calculated MV < set MV limit (0.5 – 50 L/min)

5-5

5 Troubleshooting

No Alarm 9 “Sensor mismatch”

Priority High

Set condition In all modes: If any of the three flow sensor delivers implausible data OR If the insp. pressure sensor delivers implausible data OR If the insp. pressure sensor reads ≤ –9 cmH2O for more than 500 ms OR If the insp. pressure sensor reads > 110 cmH2O for more than 500 ms OR If an additional external flow is detected

Action Check O2 flow sensor, AIR flow sensor, exp flow sensor AND recalibrate all sensors AND verify proper tubing between flow sensors and PC board B AND Replace PC board B if calibration does not remove the problem

10

“Battery failure”

High

In all modes: If sensed battery voltage > 29 V for more than 1 sec.

11

“Battery low” High

Replace defective battery OR replace PC board B if battery was not defective Recharge battery In all modes: OR If sensed battery replace battery if voltage > 24 V not rechargeable

5-6

In all modes: If sensed battery voltage < 22.5 V for more than 1 sec.

Reset condition In all modes: All of the three flow sensors reaches zero range AND the inspiratory flow sensor reads > 5 L/Min and < 120 L/min for more than 0.5 sec AND the expiratory flow sensor reads > - 5 L/Min and ≤ 140 L/min for more than 0.5 sec AND the inspiratory pressure sensor reaches zero range AND the inspiratory pressure sensor reads > -9 cmH2O for more than 0.5 sec AND the inspiratory pressure sensor reads < 110 cmH2O for more than 0.5 sec AND [(Vinsp- Vexp)/Vinsp]* 100 > -25% Battery voltage between 24 and 28 V

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

No Alarm 12 “Line supply fail”

13

14

15

Priority Set condition Low In all modes: If DC supply < 22 V AND line supply voltage < 95 VAC (200 VAC) for more than 100 msec OR If line supply voltage > 135 VAC (255 VAC) “Fan failure” High In all modes : If sensed fan rotation < 2,820 rpm OR If sensed fan rotation > 5,160 rpm “Temperatur Low In all modes: e error” If the heater temp < 5° C OR If the heater temp > 60 °C OR If the heater current > 700 mA OR If heater power > 14,4 VA OR if the heater temp. is between 42 and 48°C and PWM out of range (all for more than 60 sec) “O2 supply High In all modes: fail” If PWM signal reaches 0 at O2 flow >0 OR if PWM signal reaches maximum at O2 flow < 90 l/min OR O2 pressure switch permanently inactive (Po2< 29 PSI) OR ADC values of O2 flow sensor < 2/1024 or > 1022/1024

TM, elisa, CM-922280, rev. 3.03.a

Action Check AC power supply line, AC main switch, AC fuses, primary and secondary transformer connection and PC board fuses and replace if necessary Check fan and replace if necessary

Reset condition In all modes: If 95 VAC (200 VAC) ≤ line supply voltage ≤ 135 VAC ( 255 VAC) AND Internal main bus 13v > 12.2 V In all modes: If 2,820 rpm ≤ sensed fan rotation ≤ 5,160 rpm

Check AIR Gas intake temperature when using a compressor (> 48°C) OR Check heater system and replace , if necessary OR replace PC board B if replacing heater system does not solve the problem

In all modes: If 5°C < heater temp. < 60 °C AND if the heater current is < 700 mA And if heater power is 0 OR if PWM signal reaches maximum at AIR flow < 90 l/min OR AIR pressure switch permanently inactive (Po2< 29 PSI) OR ADC values of AIR flow sensor < 2/1024 or > 1022/1024 In all modes: If measured rate < set rate low limit

Action Check AIR supply, filter, pressure reducer and pressure switch. Check AIR prop valves, AIR flow sense tubes to PC board B Replace pneumatic assembly. Replace PC board B if replacing the pneumatic assembly does not solve the problem User alarm. Check vent settings and patient spontaneous breathing In all modes: User alarm. If measured rate > set Check vent settings rate high limit and patient spontaneous breathing In all modes: Power supply If Main 5V A>5.5 V or problem Main 5 V < 4.5 V (SS code A, check fuses, 30xx) replace PC board OR A. if Main 5V B > 5.5 V or Power supply < 4.5 V (SS code problem Main 5 V xx30) B, OR Main 13 V, Main 15 If Main 13V > 15.0 V or V, check fuses, < 11.5 V (SS code replace PC board B xx32) OR If Main 15V > 17.0 V or < 12.5 V (SS code xx33) In all modes: Check display If connection between connection, replace control panel and main DCU PC board. engine is defective Replace PC board OR A if DCU PC board if display back light is is not defective defective

Reset condition In all modes: If FiO2 set = 1.0 OR if the AIR pressure control switch (2 bar, 29 PSI) is closed AND if 0.5V < valve AIR < 11.5 V

In all modes: If measured rate ≥ set rate low limit In all modes: If measured rate ≤ set rate high limit In all modes: If 4.5 V< Main 5 V A < 5.5 V If 4.5 V < Main 5 V B < 5.5 V If 11.5 V < Main 13 V < 15 V If 12.5 V < Main 15 V < 17 V

In all modes: If CPU handshake is OK AND If display back light supply ≥ 12 V

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

No Alarm 21 “O2 sensor fail”

Priority High

Set condition In all modes: If O2 measured value ≤ 10 % OR If O2 measured value ≥ 120 %

22

“O2 concentr. low”

High

In all modes: If O2 measured value < set O2 low limit

23

“O2 concentr. high”

High

In all modes: If O2 measured value > set O2 high limit

24

“P limit reached”

Low

VCV, SIMV-VC modes: If Ppeak ≥ Plimit

25

“Button Failure”

Low

In all modes: If a button is active for more than 5 sec

26

“DC supply fail”

High

In all modes: If no AC supply active AND external DC supply connected AND external DC supply fails OR If external battery voltage < 22 V

TM, elisa, CM-922280, rev. 3.03.a

Action Check O2 sensor calibration. Check O2 sensor and replace, if necessary. Replace PC board B , if O2 sensor was not defective Check O2 sensor calibration. Check O2 sensor and replace, if necessary. Replace PC board B , if O2 sensor was not defective Check O2 sensor calibration. Check O2 sensor and replace, if necessary. Replace PC board B , if O2 sensor was not defective User alarm. Check vent. setting AND check breathing system, PEEP valve for blockage or kinked tubes Check ON/OFF switch, Selector and touch screen. Replace if necessary. Check external battery pack for charging status and recharge, if necessary, or replace if not rechargeable. Replace PC board B, if problem remains with proper working external DC supply

Reset condition In all modes: If 10% < O2 measured value < 120 %

In all modes: If O2 measured value ≥ set O2 low limit

In all modes: If O2 measured value ≤ set O2 high limit

VCV, SIMV-VC modes: If Ppeak < Plimit at the end of inspiratory time

Release button or replace touch screen

Restore 24 V DC supply OR restore external battery pack with fully charged one OR supply system by AC line supply

5-9

5 Troubleshooting No Alarm 27 “Tube occluded ?”

28

5-10

“Exp. flow sensor?”

Priority Set condition High Dyn-BiLevel mode: If measured VT-E is < 10% of set VT OR If measured VT-E is < 20 ml (adult mode) 10 ml (Pediatric mode) Low In all modes: If dirty exp. flow screen causes implausible values by e.g. nebulisation or back pressure to flow screen exit by positioning failures.

Action User alarm. Check tube for kinking or occlusion

Reset condition Measured applied volume is > 10% of set VT OR > 20 ml (Adult) / 10 ml (Pediatric)

User alarm. Check expiratory flow screen for dirt and clean, if necessary.

Measured expiratory flow data is within the tolerances.

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

5.3 Messages 5.3.1 Messages during power-up test Code Message No line supply.

00-1

00_2

Type Set condition Advice Line power supply fails OR external DC power supply fails

Battery depleted.

Advice Internal back up battery empty

Action Check line power supply, socket, power cord, plug, primary fuses and line switch. Check external battery charging level, power cord and plug. Recharge battery or replace, if necessary.

“DC mains supply”

Advice External DC supply is active

No service action necessary

Test active, Advice System is in test wait for xx secs. procedure for at least xx seconds

No service action necessary

Controller B no function.

Check SIO and B board functions and replace B board, if necessary Do not operate system on patient. Turn off the unit without pressing "Service reset" to prevent unknowing use of the system from another shift

Syste m shut down error “System error Syste during previous m shut ventilation or down front panel error battery discharged or defective. (System shutdown 4040) Do not operate system on patient. Switch off device and contact authorized service specialist.

TM, elisa, CM-922280, rev. 3.03.a

Controller problems are identified Battery on PC board A defective or Start up after a “System error” during previous ventilation

Reset condition If line power supply is restored OR If external DC power supply is reconnected

If internal back up batter is recharged If line power supply is restored Or If external DC power supply is disconnected If test is successfully finished Or If test has identified any system shutdown errors If communication between PC board A and B is OK Call authorized service specialist. The “Service reset” button is to be used by the service specialist only.

5-11

5 Troubleshooting

Code Message 01-1 Watchdog controller A does not open. 01-2

01-3

01-4

02-1

02-2

02-3

03-1

5-12

Type Syste m shut down error Watchdog Syste controller A m shut does not close. down error Watchdog Syste controller B m shut does not open. down error Watchdog Syste controller B m shut does not close. down error No line supply, Syste check line m shut power cord and down fuse. error External power supply failure, voltage too high, check external power supply. Internal power supply failure. System may not be operated. Repeat test by turning OFF and ON again Battery depleted (voltage < 22.0V) System not ready for operation. If this message appears for more than 10 min, battery needs replacement.

Set condition Watchdog problems are identified

Action Check SIO and A board functions and replace A-uC board if necessary Watchdog Check SIO and A problems are board functions and identified replace A –uC board, if necessary Watchdog Check SIO and B problems are board functions and identified replace B board, if necessary Watchdog Check SIO and B problems are board functions and identified replace B board, if necessary Line power supply Check line power fails supply, socket, power cord, plug, primary fuses, line switch and fuses on B board Syste External power Check external m shut supply voltage is supply voltage down too high error

Reset condition If communication between PC board A and B is OK If communication between PC board A and B is OK If communication between PC board A and B is OK If communication between PC board A and B is OK If line power supply is restored

If external power supply voltage is in the proper voltage range

Syste Internal power m shut supply fails. down error

Check B board Repeat test or functions and replace Check power B board, if supply system necessary.

Syste The internal back m shut up battery is down depleted. error

Recharge battery while system is supplied with line power or external DC power. If not successful, replace battery

Battery has reached sufficient voltage level within 10 minutes of recharging. Repeat test by turning elisa OFF and ON again.

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

Code Message 03-2 Battery is empty (voltage < 23.5V) If 24.0 V is not reached in 20 min, battery needs replacement. 03-3 Battery or recharger defective. Repeat test by turning OFF and ON again.

03-4

04-1

04-2

05-1

05-2

Type Syste m shut down error

Action Recharge battery while system is supplied with line power or external DC power prior to operation. If not successful replace battery Syste The internal back Check power supply m shut up battery is function or replace B down depleted board error OR Readjust charger The recharger for voltage the internal back Check battery and up battery is replace battery, if defective. necessary Battery cannot Syste The internal back Check battery fuse be switched on! m shut up battery is not and replace battery, if Repeat test by down operable. necessary. turning OFF error If not successful, and ON again. check battery and replace, if necessary Fan failure. Syste The internal fan is Check fan and Repeat test by m shut not operable. replace fan; if turning OFF down necessary and ON again. error Temperature Syste The inspiratory Check inspiratory sensor insp. m shut temperature temp sensor and Flow down sensor is not connector and malfunctions. error operable. replace pneumatic Repeat test by assembly, if turning OFF necessary and ON again. Watchdog does Syste The heater is not Check expiration not turn off m shut operable. valve control system heater. Repeat down for proper test by turning error connections, if OFF and ON necessary replace again. exp. valve control assembly or B board Exp. Flow Syste Expiratory flow Check expiration sensor heater m shut sensor heater valve control system cannot be down fails. for proper switched on. error connections, if Repeat test by necessary replace turning OFF exp. valve control assembly or B board and ON again.

TM, elisa, CM-922280, rev. 3.03.a

Set condition The internal back up battery is empty. The battery voltage is x V.

Reset condition Battery has reached 24.0 V within 20 minutes. If not: Repeat test by turning elisa OFF and ON again Battery and charger are working properly

Battery works OK

Fan works OK

Temperature sensor delivers proper signal

Heater can be turned off

Heater can be turned on

5-13

5 Troubleshooting Code Message 05-3 Heater or heater current limiter failure. Repeat test by turning OFF and ON again.

Type Syste m shut down error

Set condition Expiratory flow sensor heater current limiter fails.

05-4

Heater temperature sensor malfunction. Repeat test by turning OFF and ON again.

Syste m shut down error

Expiratory flow sensor heater temperature sensor malfunction or defective.

Expiration valve missing or not in proper position.

Syste m shut down error

06-3

07-1

08-1

5-14

Expiration valve is not inserted OR Expiration valve is not properly assembled OR Expiration valve is not properly inserted Expiration valve Cautio Expiration valve unlocked. n locking mechanism was Ready to be removed from operated to device” unlock the expiration valve Malfunction of Syste Expiratory flow locking m shut sensor valve lock mechanism of down malfunction or expiration error defective. valve. Unlock exp. valve again via system test menu. EPROM Syste Panel EPROM versions do not m shut version and match. down internal main Check software error board EPROM rev. no. of versions do not panel and main match. engine. Controller or Syste Controller or RAM RAM on main m shut problems are PCB defective. down identified on main Repeat test by error PC board turning OFF and ON again.

Action Check expiration valve control system for proper connections, if necessary replace exp. valve control assembly or B board Check expiration valve control system for proper connections, if necessary replace exp. valve control assembly or B board

Reset condition Heater current limiter works OK

Insert expiration valve assembly and let lock

Insert expiration valve into valve lock OR assemble expiration valve properly and reinsert into valve lock

Heater temperature sensor works OK

Remove expiration Unlock, remove valve from valve lock and reinsert expiration valve

User may try to activate the locking mechanism by system test menu. If not successful, replace expiration valve locking system

Insert expiration valve into valve lock OR assemble expiration valve properly and reinsert into valve lock

Check EPROM versions between A and B board. Verify that the EPROM are properly inserted

Exchange entire panel with a matching version

Repeat system test Controller or for 5 times to load RAM is identified new data into to be OK. EEPROM or replace B board, if necessary TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

Code Message 08-2 Controller or RAM on front PCB defective. Repeat test by turning OFF and ON again. 09-1 EPROM on main PCB defective. Repeat test by turning OFF and ON again. 09-2 EPROM on front PCB defective. Repeat test by turning OFF and ON again. 09-3 EEPROM on main PCB defective. Repeat test by turning OFF and ON again. 09-4 EEPROM on front PCB defective. Repeat test by turning OFF and ON again. 10-1 Button defective or permanently pressed. Release button or repeat test by turning OFF and ON again. 10-2 Buzzer on main PCB defective. Repeat test by turning OFF and ON again. 10-3 Buzzer on front PCB defective. Repeat test by turning ON and Off again.

Type Syste m shut down error

Set condition Controller or RAM problems are identified on panel PC board

Action Repeat system test for 5 times to load new data into EEPROM or replace A board, if necessary

Reset condition Controller or RAM is identified to be OK.

Syste EPROM problems m shut are identified on down main PC board error

Check proper seating EPROM is of EPROM in socket identified to be and replace B OK. EPROM, if necessary

Syste EPROM problems m shut are identified on down panel PC board error

Check proper seating EPROM is of EPROM in socket identified to be and replace A OK. EPROM, if necessary

Syste m shut down error

EEPROM problems are identified on main PC board

Repeat system test EEPROM is for 5 times to load identified to be new data into OK. EEPROM or replace B board, if necessary

Syste m shut down error

EEPROM problems are identified on panel PC board

Repeat system test EEPROM is for 5 times to load identified to be new data into OK. EEPROM or replace A board, if necessary

Syste m shut down error

Any front panel button or the ON/OFF button is defective Or any button is permanently active

Check button connection within control panel, if necessary replace front label with buttons

Check for permanently activated button on front panel OR repeat test by turning OFF and ON again

Check connection PC board B and Alarm system, if necessary replace main alarm system Check connection PC board A and Alarm system, if necessary replace front alarm system

Buzzer is identified to be OK.

Syste Buzzer problems m shut are identified on down main PC board error Syste Buzzer problems m shut are identified on down panel PC board error

TM, elisa, CM-922280, rev. 3.03.a

Buzzer is identified to be OK.

5-15

5 Troubleshooting

5.3.2.Messages during system test Code Message “Make sure no patient is connected while performing the system test. Complete system set up, seal Y-piece. Start system test by pressing

12-1 No O2 gas supply. Check O2 gas supply or for single gas AIRsupply press

13-1 No AIR gas supply. Check AIR gas supply or for single O2supply press

14-1 Oxygen flow sensor miscalibrated or defective, measured offset out of range. Repeat test by pressing .

5-16

Type Set condition Advice System has successfully passed power up test and is ready to start system test

Action Complete system set up with breathing system and airway management components intended to be used upon following breathing mode. Seal y-piece by plugging y-piece onto the sealer at the expiration valve block

Advice Insufficient O2 supply pressure

Check for proper O2 O2 supply gas supply and for pressure clean inlet gas filters. exceeding 2 bar (28 PSI) OR repeat test by pushing Check for proper AIR AIR supply gas supply and for pressure clean inlet gas filters. exceeding 2 bar (28 PSI) OR repeat test by pushing Recalibrate O2 flow O2 flow sensor line signal within proper offset range OR repeat test by pushing

Advice Insufficient AIR supply pressure

Advice O2 flow sensor is miscalibrated OR O2 flow sensor is defective

Reset condition Proceed with system test by pushing

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

Code Message 14-2 Oxygen flow valves do not open or no signal from oxygen flow sensor. Check O2 gas supply and press .” 14-3 Oxygen flow offset valve does not react. Repeat test by pressing . 15-1 Oxygen valves do not properly close. Check O2 gas supply or repeat test by pressing . 15-2 2nd oxygen flow valve does not react. Repeat test by pressing .

Type Set condition Advice Insufficient O2 supply pressure

15-3

Advice O2 flow valve Check O2 valve and problem identified replace pneumatic assembly, if necessary

15-4

Malfunction in oxygen valve testing. Test takes too long, repeat test by pressing . Limited flow in oxygen gas supply. Check gas supply for sufficient flow delivery” Repeat test by pressing .

Action Check for proper O2 gas supply

Advice O2 flow sensor Replace B board offset valve problem identified

Advice O2 valves do not properly close OR O2 gas supply pressure too high Or O2 valve seat dirty.

Check O2 valve and replace pneumatic assembly, if necessary

Advice O2 flow valve Check O2 valve and problem identified replace pneumatic assembly, if necessary

Advice O2 flow sensor detects a max flow of < 110 L/Min, when 120 L/Min flow is tested

TM, elisa, CM-922280, rev. 3.03.a

Check gas supply hose, plug, line and filters for flow restrictions.

Reset condition O2 supply pressure exceeding 2 bar (28 PSI) OR repeat test by pushing

O2 flow offset valve operates properly OR repeat test by pushing O2 valves operate properly OR repeat test by pushing

2nd O2 valve operates properly oR Proceed with system test by pushing Repeat test by pushing

O2 flow sensor detects > 110 L/Min at 120 L/Min test OR repeat test by pushing

5-17

5 Troubleshooting

Code Message 16-1 AIR flow sensor miscalibrated or defective, measured offset out of range. Repeat test by pressing . 16-2 AIR flow valves do not open or no signal from AIR flow sensor. Check AIR gas supply Repeat test by pressing . 16-3 “AIR flow offset valve does not react. Repeat test by pressing . 17-1 AIR valves do not properly close. Check AIR gas supply or repeat test by pressing . 17-2

17-3

5-18

Type Set condition Action Advice AIR flow sensor is Recalibrate AIR flow miscalibrated line OR AIR flow sensor is defective

Advice Insufficient AIR supply pressure

Reset condition AIR flow sensor signal within proper offset range OR repeat test by pushing

Check for proper AIR AIR supply gas supply pressure exceeding 2 bar (28 PSI) OR repeat test by pushing

Advice AIR flow sensor Replace B board offset valve problem identified

AIR flow offset valve operates properly Or repeat test by pushing Check AIR valve and AIR valves replace pneumatic operate properly assembly, if OR necessary repeat test by pushing

Advice AIR valves do not properly close OR AIR gas supply pressure too high OR AIR valve seat dirty. 2nd Air flow Advice Air flow valve Check AIR valve and Repeat test by problem identified replace pneumatic pushing valve does not react. Repeat assembly, if test by pressing necessary . Malfunction in Advice AIR flow valve Check AIR valve and Repeat test by AIR valve problem identified replace pneumatic pushing testing. Test assembly, if takes too long. necessary Repeat test by pressing .

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

Code Message 17-4 Limited flow in AIR gas supply. Check gas supply for sufficient flow delivery. Repeat test by pressing . 18-1 Pressure sensor miscalibrated or defective, measured offset out of range. Repeat test by pressing . 18-2 No pressure increase in breathing circuit. Check breathing circuit and expiration valve for leaks. Press .

18-3

19-1

Type Set condition Advice Air flow sensor detects a max flow of < 110 L/Min, when 120 L/Min flow is tested

Action Check gas supply hose, plug, line and filters for flow restrictions.

Reset condition Air flow sensor detects > 110 L/Min at 120 L/Min test or repeat test by pushing

Advice Pressure sensor is miscalibrated OR Pressure sensor is defective

Recalibrate pressure sensor

Pressure sensor signal within proper offset range OR repeat test by pushing

Advice No pressure increase measured up to 30 cmH2O within 1 secs caused by a non-sealed ypiece OR A leak in the breathing circuit OR A leak in the expiration valve Advice Pressure sensor offset valve problem identified

Check PEEP membrane for proper assembly and positioning and replace PEEP membrane, if necessary

Pressure increase is measured in the breathing circuit OR repeat test by pushing

Pressure Replace B board sensor offset valve does not react. Repeat test by pressing . Pressure Advice Low pressure Check the breathing sensor increase circuit for leaks and malfunction. measured caused check the expiration Leakage, check by a pressure valve for proper expiration sensor function and restart valve. Repeat malfunction OR the system test. test by pressing a leak in the . breathing circuit OR A leak in the expiration valve

TM, elisa, CM-922280, rev. 3.03.a

Pressure sensor offset valve operates properly OR repeat test by pushing

Pressure increase is measured in the breathing circuit OR repeat test by pushing

5-19

5 Troubleshooting

Code Message Type 19-2 Electronic Advice pressure safety valve in inspiratory line does not open. Repeat test by pressing . 20-1 No pressure Advice increase in system. Leakage xxx mL/min. Check y-piece, breathing circuit and expiratory valve for leaks. Press .

20-2

20-3

20-4

5-20

Action Check pressure safety valve and replace pneumatic assembly, if necessary

Reset condition Electronic pressure safety valve opens properly OR repeat test by pushing

Check the breathing circuit for leaks and seal y-piece

Pressure increase is measured in the breathing circuit OR repeat test by pushing

Leakage in Advice Leakage in Check the breathing circuit for leaks breathing circuit breathing circuit exceeds 1.000 too high. Leakage xxx mL/min. mL/min. Check y-piece, breathing circuit and expiration valve for leaks Press . Operational Advice Pressure increase Do not squeeze valve measured with breathing circuit malfunction. sealed valves components while in Repeat test by system test pressing .

Seal leaks OR repeat test by pushing

Proportional or nebulizer valve does not properly close. Repeat test by pressing .

Set condition Electronic overpressure relief valve in inspiration line does not react OR Pressure release too slow No pressure increase measured above 50 cmH2O within 5 secs caused by a non-sealed ypiece OR A leak in the breathing exceeding 1.000 mL/min circuit

Proper pressure increase is measured in the breathing circuit OR repeat test by pushing Advice Pressure increase Do not squeeze Proper pressure measured with breathing circuit increase is sealed valves components while in measured in the system test or breathing circuit check valves for OR leaks and replace repeat test by pneumatic assembly, pushing if necessary

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting Code Message 21-1 Total resistance too high. Check breathing circuit and expiratory valve for resistance. Accept by pressing Alarm Silence Button or repeat test by pressing .” 21-2 n/a 21-3 Expiratory valve data not matching. Check breathing circuit. Press . 21-4 Expiration valve cannot control P < 4 cmH2O. Check proper assembly of expiration valve or repeat test by pressing . 22-1 Overpressure relief valve P < 95 cmH2O. Repeat test by pressing .

22-2

Overpressure relief valve P > 110 cmH2O. Repeat test by pressing .

Type Set condition Advice Total resistance exceeding 15 cmH2O /L/s

Action Check breathing circuit for kinked hoses or components causing high resistance and check expiratory valve assembly

Reset condition Total resistance below 15 cmH2O /L/s OR Accept high resistance by pressing alarm silence button or repeat test by pushing

Advice Expiratory valve data do not match with resistance and compliance data

Check breathing circuit for kinked hoses or components causing high resistance

Expiratory valve data in proper range OR repeat test by pushing

Advice Expiration valve cannot control pressure < 4 cmH2O.

Check breathing circuit for leaks and check expiratory valve for proper assembly and check breathing circuit for kinked hoses or components causing high resistance Check pressure safety valve and recalibrate or replace pneumatic assembly, if necessary

Expiration valve can control pressure < 4 cmH2O OR Proceed with system test by pushing

Advice Overpressure relief valve reacts on pressure < 95 cmH2O

Overpressure relief valve operates between 95 and 110 cmH2O OR Proceed with system test by pushing Advice Overpressure Check pressure Overpressure relief valve reacts safety valve and relief valve on pressure > 110 recalibrate or replace operates cmH2O pneumatic assembly, between 65 and if necessary 110 cmH2O Or Proceed with system test by pushing

TM, elisa, CM-922280, rev. 3.03.a

5-21

5 Troubleshooting

Code Message 23-1 Exp. flow sensor miscalibrated or defective, measured offset out of range. Repeat test by pressing . 23-2 Expiration flow offset valve does not react or wrong signal from expiration flow sensor. System may not be operated. Repeat test by pressing . 23-3 Expiration flow offset valve does not react Repeat test by pressing . 24-1

5-22

Type Set condition Advice Expiratory flow sensor is miscalibrated OR Flow sensor is defective Or flow screen is dirty or blocked

Action Recalibrate expiration flow sensor or clean or replace expiratory flow screen, if necessary

Reset condition Expiratory flow sensor signal within proper offset range OR Proceed with system test by pushing

Caution

Expiration flow sensor offset valve problem identified OR flow sensor is defective Or flow screen is dirty or blocked

Check tube from exp. flow sensor port on valve assembly to B board and replace B board, if necessary

Expiration flow offset valve operates properly OR Proceed with system test by pushing

Caution

Expiration flow sensor offset valve problem identified

Replace B board

Expiration flow offset valve operates properly OR Proceed with system test by pushing Expiration flow sensor signal in proper range Or Proceed with system test by pushing

Exp. flow Advice Expiration flow sensor value sensor value too too high with high with AIR AIR flow. flow. Check oxygen OR sensor flow screen is calibration. dirty or blocked Check OR expiration valve oxygen value for resistance, incorrect ensure valve OR matches blue Newborn selected patient valve assembly type or repeat inserted but test by pressing Adult/Pedia mode . selected

Check proper expiration valve type is inserted (silver for adult/pediatric and blue for newborn) or remove expiration valve from lock, reassemble and reinsert prior to restart the system test or recalibrate O2 cell or recalibrate Air flow line or replace pneumatic assembly

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

Code Message Type Advice 24-2 Exp. flow sensor value too low with AIR flow. Check oxygen sensor calibration. Check expiration valve for resistance, ensure valve matches selected patient type or repeat test by pressing . Advice 24-3 Exp. flow sensor value too high with O2 flow. Check oxygen sensor calibration. Check expiration valve for resistance, ensure valve matches selected patient type or repeat test by pressing .

TM, elisa, CM-922280, rev. 3.03.a

Set condition Expiration flow sensor value too low with AIR flow. OR Oxygen value incorrect OR silver Adult/Pedia valve assembly inserted but Newborn mode selected

Action Check proper expiration valve type is inserted (silver for adult/pediatric and blue for neonate) or remove expiration valve from lock, reassemble and reinsert prior to restart the system test or recalibrate O2 cell or recalibrate Air flow line or replace pneumatic assembly Expiration flow Check proper sensor value too expiration valve type high with O2 flow. is inserted (silver for OR adult/pediatric and flow screen is dirty blue for neonate) or blocked Or check proper OR expiration valve type oxygen value is inserted (silver for incorrect adult/pediatric and OR blue for newborn) blue Newborn Or remove expiration valve assembly valve from lock, inserted but reassemble and Adult/Pedia mode reinsert prior to selected restart the system test or recalibrate O2 cell or recalibrate Air flow line or replace pneumatic assembly

Reset condition Expiration flow sensor signal in proper range OR Proceed with system test by pushing

Expiration flow sensor signal in proper range OR Proceed with system test by pushing

5-23

5 Troubleshooting

Code Message Type Advice 24-4 Exp. flow sensor value too low with O2 flow. Check oxygen sensor calibration. Check expiration valve for resistance, ensure valve matches selected patient type or repeat test by pressing .

Set condition Expiration flow sensor value too low with O2 flow. OR Oxygen value incorrect OR silver Adult/Pedia valve assembly inserted but Newborn mode selected

25-1

Nebulizer flow Advice Expiration flow with AIR out of sensor value too low with AIR range. Repeat test by pressing Nebulizer flow. .

25-2

Nebulizer flow Advice Expiration flow with O2 out of sensor value too range. Repeat low with O2 test by pressing Nebulizer flow. .

25-3

Nebulizer flow Advice Nebulizer flow data does not data incorrect match. Repeat test by pressing .

5-24

Action Check proper expiration valve type is inserted (silver for adult/pediatric and blue for neonate) Or check proper expiration valve type is inserted (silver for adult/pediatric and blue for newborn) or remove expiration valve from lock, reassemble and reinsert prior to restart the system test or recalibrate O2 cell or recalibrate Air flow line or replace pneumatic assembly Check nebulizer to match specs and for proper operation and leak tightness

Reset condition Expiration flow sensor signal in proper range OR Proceed with system test by pushing

Expiration flow sensor signal in proper range OR Proceed with system test by pushing Or call authorized service specialist Check nebulizer to Expiration flow match specs and for sensor signal in proper operation and proper range OR leak tightness Proceed with system test by pushing Or call authorized service specialist Check nebulizer to Nebulizer flow match specs and for data in proper proper operation and range or proceed leak tightness and with system test range of 4 – 12 l/min by pushing at given pressure

OR call authorized service specialist

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting Code Message Type 26-1 Oxygen sensor Advice value too low. Re-calibrate O2 sensor. Press .” 26-2

Oxygen sensor Advice Oxygen sensor value too high. above 24% at Re-calibrate O2 21% setting. sensor. Press .” Open y –piece.

27-2

27-3

n/a

Set condition Oxygen sensor value below 19% at 21% setting.

Advice The test sequence requires opening the y-piece to measure the inspiratory resistance Advice Inspiratory resistance exceeding 6 cmH2O /L/s.

Action Verify proper O2 supply and recalibrate the oxygen sensor Or replace O2 cell Verify proper Air supply and recalibrate the oxygen sensor OR replace O2 cell Open y-piece or remove y-piece from sealer of expiration block

Reset condition Oxygen sensor values in proper range OR proceed with system test by pushing Oxygen sensor values in proper range OR Proceed with system test by pushing Opened y-piece.

Measured inspiratory resistance too high. Check breathing circuit. Accept by pressing Alarm Silence Button or repeat test by pressing . Measured Advice Breathing circuit resistance out resistance above of range. Check 30 cmH2O /L/s breathing circuit OR Press .” Resistance could not be detected properly

Check breathing circuit for kinked hoses or components causing high resistance

Inspiratory resistance in proper range OR accept high resistance by pressing Alarm Silence Button or repeat test by pushing

Check breathing circuit for kinked hoses or components causing high resistance and check expiration valve for proper assembly and do not manipulate breathing system while in test

“Low battery Advice Battery capacity capacity not sufficient to identified, either support at least 2 battery is minutes of device discharged or operation in back defective” up mode

Allow battery to recharge for at least 30 minutes and repeat test OR replace battery

Breathing circuit resistance below 30 cmH2O /L/s OR resistance could be detected properly OR Proceed with system test by pushing Battery capacity sufficient to supply device for a minimum of 2 minutes in back up mode

TM, elisa, CM-922280, rev. 3.03.a

5-25

5 Troubleshooting

Code Message Type Advice System test OK. To start ventilation . Compliance xx mL/cmH2O Resistance xx cmH2O/L/s Leakage x mL/min Nebulizer flow x l/min (last value) Exp. flow sensor data readjusted“

5-26

Set condition System test is finished. Total Compliance, insp. Resistance, total leakage, nebulizer flow data of used breathing circuit are identified and will be used for compensation during following ventilation. Flow of adapted nebulizer is measured or last measured value is used. Expiration flow sensor was readjusted

Action Reset condition Connect y-piece to n/a patient and start ventilation by pushing

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

5.3.3 Messages during O2 sensor calibration Code Message No signal: wrong gas or sensor defective. Signal low: sensor used-up or sensor failure.

Signal high: sensor failure or PCB failure.

Calibration successfully finished.

Type Set condition Advice If sensor signal does not exceed 40% at calibration with 99% O2 Advice If sensor signal does not reach minimum data sheet value at 99% OR 21% O2 Advice If sensor signal exceeds maximum data sheet value at 99% OR 21% O2

Action Ensure proper O2 gas supply OR Replace O2 sensor Ensure proper O2 gas supply OR Ensure proper AIR gas supply OR Replace O2 sensor

Ensure proper O2 gas supply OR Ensure proper AIR supply OR Replace O2 sensor Or B board Advice If calibration Finish the calibration settles properly at procedure 21% with AIR AND 99% with O2

TM, elisa, CM-922280, rev. 3.03.a

Reset condition Sensor signal exceeds 40%at calibration with 99% O2 If sensor signal is in between minimum and maximum data sheet values at 21% with AIR AND 99% with O2 If sensor signal is in between minimum and maximum data sheet values at 21% with AIR AND 99% with O2 n/a

5-27

5 Troubleshooting

5.3.4 Messages during operation No. Message 1 Battery xx Min.

Type Set condition Advice In all modes: If line power supply fails OR If external DC power supply fails OR If internal battery is charging

Meaning System power supply from internal back up battery. Remaining operating time on battery is “xx Min”

2 Tube: a, xx, yy%

Advice In all modes: If Tube Compensation is used

3 No test

Advice In all modes: If system test had not been performed

4 Only O2

Advice In all modes: If during system test single gas operation for O2 only was confirmed Advice In all modes: If during system test single gas operation for AIR only was confirmed Advice In all modes: System is in “adult mode”

Tube Compensation is active for a type of tube with xx mm diameter and yy % compensation System test to identify breathing circuits compliance, resistance and leakage was not performed. System uses default data to compensate. Only O2 gas supply with setting FiO2 default to 100% in all modes

5 Only AIR

6 Adult

7 Pedia

5-28

Advice In all modes: System is in “pediatric mode”

Reset condition In all modes: If line power is reconnected OR If external DC power supply is reconnected OR If internal battery is fully charged In all modes: If Tube Compensation is turned off Perform system test

Perform system test with AIR gas supply

Only AIR gas supply with setting FiO2 default to 21% in all modes

Perform system test with O2 gas supply

For all system settings adult mode default values are used For all system settings pediatric mode default values are used

Select “pediatric” to change

Select “Adult” to change

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting No. Message 8 “Newborn”

9 Standby

Type Set condition Advice In all modes: System is in “Newborn mode” (Optional) Advice System was moved into standby mode

10 Apnea vent.

Caution

11 Pre oxygen xx.

Advice Automatic suction routine ASR activated. 1st phase

12 Suction xx.

Advice Automatic suction routine ASR activated. 2nd. phase

13 Post oxygen xx.

Advice Automatic suction routine ASR activated. 3rd phase

14 Freeze

Advice Graphic freeze function was activated

15 System open?

Advice Pressure below PEEP OR patient disconnected OR system disconnected

TM, elisa, CM-922280, rev. 3.03.a

No breathing action is detected within the last apnea time delay.

Meaning For all system settings Newborn mode default values are used System starts By-flow after 15 secs to identify reconnection of a patient (APD). All alarms are silenced

Reset condition Select Newborn to change

Connect a patient to the y-piece OR activate the On/Off Button for more than 3 secs to turn off the system Patient has stopped Activate any breathing for more ventilation mode than the apnea delay in the vent. mode time. System has menu started apnea back up ventilation mode Pre oxygenation Deactivate phase of automatic automatic suction suction routine is in routine ASR operation Or Disconnect patient Suction is in process Deactivate for at least xx automatic suction routine ASR Or reconnect patient Post oxygenation Deactivate phase of automatic automatic suction suction routine is in routine ASR operation for at least xx . Graphics in screen Deactivate freeze are frozen free zed in function place for better analysis. System cannot detect Reconnect sufficient pressure patient OR increase. Activate the On/Off button for more than 3 secs to turn off the system

5-29

5 Troubleshooting No. Message 16

17

18

+

-

19 I=xx s, P=yy %, E=zz s

20 Apnea xx

21 “I:E =xx:yy, E=z.zz s” (In Option Newborn)

22 “Switch off device? Yes: Enter, No: any button”

5-30

Type Set condition Advice The nebulizer function was activated Advice The AC supply was activated.

Meaning Nebulizer function is active.

Reset condition Turn OFF nebulizer function. System is supplied Turn OFF or by AC line power disconnect AC supply. line supply OR turn on DC mains line supply. Advice The external DC System is supplied Turn OFF or supply was by external DC power disconnect activated. supply. external power supply OR turn on AC mains line supply. Advice A soft key with a Information about the Push Selector to direct influence to absolute timing: I= xx confirm displayed data the ventilator s timing was inspiration time = xx activated secs P= yy % inspiratory pause = yy % of inspiration time, E= zz s expiration time = zz secs Caut- No breathing Patient has stopped Perform ion action is detected breathing for more breathing within the last than the apnea delay activities and apnea time delay. time. Elapsed time is start ventilation xx secs support Advice A parameter with Information about the Push any blue a direct influence I:E Ratio as a result parameter to to the ventilator of Tinsp and rate return to normal timing was setting: I:E xx:yy operation activated, e.g. (inspiratory : Tinsp, rate. expiratory ratio) E=zz.z s (expiration time = z.zz secs) Caut- System in Software switch off of Push any button ion Standby elisa by activating the to return to Or system open? button normal operation And On/Off button activated for more than 3 secs

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting No. Message 23 “Battery not fully charged. Switch off: ”

Set condition System in Standby Or system open ? And On/Off button activated for more than 3 secs AND internal back up battery not fully charged 24 “System error # ” Caut- Any system error ion detected during permanent system check 25 “Cross limits? Advice Cross limit for e.g. Confirm ” Pinsp, T-Insp, (In Option Peep or PS is Newborn) reached. 26 “CPAP/PSV Advice In Dyn-BiLevel the reached since automatic setting hh:mm:ss ” of Pinsp has (In Dyn-BiLevel) reached the lower limit and is identical to PS. . 27v “Use exp. filter ”

Type Caution

Meaning Battery is not yet fully charged and system denies being turned off. If necessary Software switch off of elisa by activating the

button

Reset condition Push any button to return to normal operation

Refer to section 5.3.5 “System shut down messages”

The system prevents Accept to pass to pass the cross the cross limits limit. by pushing the Selector Patient is virtually in In Dyn-BiLevel CPAP mode the automatic practicing a setting of Pinsp is spontaneous greater than PS. breathing trial. A stop watch starts to indicate duration of this status. Advice In all modes: The system starts the Turn the When nebulizer is nebulizer function. nebulizer function activated, appears off for 15 seconds Or after start. the 15 seconds have expired

TM, elisa, CM-922280, rev. 3.03.a

5-31

5 Troubleshooting

5.3.5 System shut down messages

Error code 11yy

The system shut down message displays in the format “System shutdown error xxyy” and is intended to be a help for complex failure analysis. The message consist of a 4 digit code “ xxyy”, that represents the last information status prior to the microprocessor systems turn down. • The “xx” represents the last “safe” status of micro controller A • The “yy” represents the last “safe” status of micro controller B Alarming Set condition Possible failure Action uC A Timer 3 system Improper connection of Check cable from front problem internal SIO cable panel bracket to X 14 on B board and replace, if necessary Improper connection of external SIO cable (Control panel cable) Or Connection problem with external SIO cable connector (Lemosa plug) Defective uC controller A or Defective safety diode on PC board A Defective Fuse SI 21, SI 22

13yy

A

14yy

A

15yy

A

17yy

A

SIO cannot send

18yy

A

AD converter defective

5-32

Timer 6 system problem Front side routine without function SIO data non plausible

Defective uC controller A Defective uC controller A ESD or EMI problem

Check front panel cable and plug (Lemosa) and replace, if necessary

Replace PC board A

Check fuse SI 21 and SI 22 and replace, if necessary Replace PC board A Replace PC board A

Check environment for ESD or EMI source Improper connection of Check front panel cable external SIO cable and plug (Lemosa) and (Control panel cable) Or replace, if necessary Connection problem with external SIO cable connector (Lemosa plug) Defective uC controller Replace PC board A A Defective uC controller Replace PC board A A Defective uC controller Replace PC board A A TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting Error code 19yy

Alarming Set condition uC A Improper communication between uC A and DCU board

A

20yy to 23yy 30yy

A

33yy

A

xx10

B

xx11

B

xx12

B

xx13

B

xx14

B

xx15

B

Possible failure

Action

Cable problem between PC board A and DCU board Defective uC controller A Defective PC board A Defective DCU board Defective uC controller A

Check cable and plug

Safety relevant data non plausible 5 V bus A out of Fuse SI 3 defective range Defective PC board A Defective uC controller A Panel supply Fuse SI 1 defective voltage out of range Defective PC board A Defective safety diode on PC board B AD converter Defective uC controller B defective Timer 3 system Improper connection of problem internal SIO cable

Timer 5 system problem Timer 6 system problem Front side routine without function SIO data non plausible

Check fuse SI 3 and replace, if necessary Replace PC board A Replace PC board A Check fuse SI 1 and replace, if necessary Replace PC board A Replace PC board B Replace PC board B Check cable from front panel bracket to X 14 on B board and replace, if necessary Check front panel cable and plug (Lemosa) and replace, if necessary

Improper connection of external SIO cable (Control panel cable) Or Connection problem with external SIO cable connector (Lemosa plug) Defective uC controller B Defective uC controller B

Replace PC board B Replace PC board B

Defective uC controller B

Replace PC board B

Defective uC controller B Software down ESD or EMI problems

Replace PC board B Restart and check Check environment for ESD or EMI source Check front panel cable and plug (Lemosa) and replace, if necessary

Improper connection of external SIO cable (Control panel cable) Or Connection problem with external SIO cable connector (Lemosa plug) Defective uC controller B

TM, elisa, CM-922280, rev. 3.03.a

Replace PC board A Replace PC board A Replace DCU board Replace PC board A

Replace PC board B

5-33

5 Troubleshooting

Error code xx16

Alarming uC B

xx17

B

xx20 to xx29 and xx50 Xx27

B

B

xx30

B

xx32

B

xx33

B

xx35

B

xx36

B

xx40

-

5-34

Set condition

Possible failure

Action

SIO data not received

ESD or EMI problems

Check sum for pressure sensor data incorrect 5 V bus B out of range

Defective PC board B Calibration does not match Fuse SI 28defective

Check environment for ESD or EMI source Improper connection of Check front panel cable external SIO cable and plug (Lemosa) and (Control panel cable) Or replace, if necessary Connection problem with external SIO cable connector (Lemosa plug) Defective uC controller Replace PC board B B SIO cannot send Defective uC controller Replace PC board B B Safety relevant Defective uC controller Replace PC board B data non plausible B

13 V bus (valve voltage) out of range 15 V bus (panel voltage) out of range

Internal battery empty and fan too slow Internal battery depleted

Watchdog relay turned off

Replace PC board B Recalibrate all sensors Check fuse SI 28 and replace, if necessary Replace PC board B Replace PC board B

Defective PC board B Defective uC controller B Defective power supply Replace PC board B system Defective power supply system Improper connection of external SIO cable (Control panel cable) Or Connection problem with external SIO cable connector (Lemosa plug) Battery empty

Battery empty

Defective PC board B Defective PC board A

Replace PC board B Check front panel cable and plug (Lemosa) and replace, if necessary

Recharge internal battery

Recharge internal battery and check, if battery gets proper recharged and replace if necessary Replace PC board B Replace PC board A

TM, elisa, CM-922280, rev. 3.03.a

5 Troubleshooting

Error code 4040

Alarming Set condition status Message Content of 4040 appears key was incorrect upon power up test

Device was shut down during previous ventilation.

Message Micro A has appears initiated a reset. upon shut down during ventilation .

TM, elisa, CM-922280, rev. 3.03.a

Possible failure

Action

Battery on PC board A Replace battery on PC discharged or defective board A. When having replaced battery on PC board A, message returns upon first power up and needs acceptance by pressing the button. Power supply failure on Replace PC board A. PC board A When having replaced PC board A, message returns upon first power up and needs acceptance by pressing the button. Power supply failure on Replace PC board A. PC board A When having replaced PC board A, message returns upon first power up and needs acceptance by pressing the button.

5-35

5 Troubleshooting

Notes

5-36

TM, elisa, CM-922280, rev. 3.03.a

6 Maintenance

In this section

6.1 General instructions 6.2 Maintenance schedule 6.2.1 Every twelve (12) months 6.2.2 Every twenty-four (24) months 6.2.3 Every sixty (60) months

TM, elisa, CM-922280, rev. 3.03.a

6-2 6-3 6-3 6-4 6-4

6-1

6 Maintenance

6.1 General instructions

6-2

WARNING

Do not perform testing or maintenance on the elisa CC ventilator while it is being used to ventilate a patient. Possible injury can result.

WARNING

Items can be contaminated due to infectious patients. Wear sterile rubber gloves to protect against the spread of infectious agents to you and others.

WARNING

Obey infection control and safety procedures. Used equipment may contain blood and other body fluids.

WARNING

The internal back up battery is a sealed lead acid type battery and contains toxic material. - Do not open the battery. - Do not short circuit battery terminals. - Do not dispose the battery into open fire. - Do not charge in a sealed box. - Do not apply mechanical shock. - If exposed to electrolyte (acid) wash immediately with plenty of water. The battery must be disposed of in accordance with applicable regulatory requirements in effect at the time and place of disposal.

WARNING

The oxygen sensor is a fuel cell type sensor and contains toxic material. - Do not open the oxygen sensor. - Do not dispose the oxygen sensor into open fire. - Do not apply mechanical shock. - If exposed to electrolyte (acid) wash immediately with plenty of water. The oxygen sensor must be disposed of in accordance with applicable regulatory requirements in effect at the time and place of disposal.

TM, elisa, CM-922280, rev. 3.03.a

6 Maintenance

6.2 Maintenance schedule Perform the user maintenance from the procedures and schedules in the elisa CC ventilator User manual.

6.2.1. Every twelve (12) months

Perform the following every twelve months: 1.

Remove all user level breathing system assemblies and components from the breathing system.

2.

Remove the expiration valve from the main engine.

3.

Open the main engine according to section 7.2.5.

4.

Inspect the elisa CC ventilator and the removed components for distortion, deterioration and/or cracks.

5.

Inspect and replace the expiration valve components according to section 7.9.2.

6.

Ensure that the UBD (use before date) of the O2 cell is at least 6 months. Replace the O2 sensor, if necessary, according to section 7.9.6.

7.

Replace sinter filter and O-ring at NIST connector according to section 7.9.10 for AIR and O2.

8.

Perform AIR flow sensor calibration according to section 4.7.3.

9.

Perform O2 flow sensor calibration according to section 4.7.4.

10. Perform expiratory flow sensor calibration according to section 4.7.5. 11. Perform Airway pressure sensor calibration according to section 4.7.6. 12. Perform Overpressure relief valve calibration according to section 4.7.7. 13. Perform Battery test according to section 4.8. 14. Reassemble and close the main engine. 15. Perform the Post-service checkout according to section 3.1.

TM, elisa, CM-922280, rev. 3.03.a

6-3

6 Maintenance

16. Perform the electrical safety test for • Ground resistance

(< 0.2 Ω)

• Leakage current

(< 500 uA)

• Insulation resistance (> 10 M Ω) (according to VDE 751). 17. When device is operated in elevated temperature area replace the internal back up battery according to section 7.9.1.

6.2.2. Every twenty four (24) months

In addition to the 12 month requirements, perform the following every twenty-four months: 1.

Replace the internal back up battery according to section 7.9.1.

2.

Replace the free breathing valve, according to section 7.9.12..

3.

Replace the batteries(2) of the external battery pack according to section 11.1.1 and charge installed batteries according to UM section 5.1.2

6.2.3 Every sixty (60) months

6-4

In addition to the 24 month requirements, perform the following every sixty months: 1. Replace Li-battery on PC board A according to section 7.8.3

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

In this section

7.1 General instructions 7.2 Open the system 7.2.1 Remove the exp. valve 7.2.2 Remove the control panel 7.2.3 Open the control panel 7.2.4 Control panel assemblies 7.2.5 Open the main engine 7.2.6 Remove the control panel mounting plate 7.2.7 Main engine assemblies 7.3 Service assemblies 7.4 Change the line voltage 7.5 Software replacement 7.5.1 Change the (A) EPROM 7.5.2 Change the main (B) EPROM 7.6 Change the unit of pressure 7.7 Change fuses 7.7.1 Line fuses 7.7.2 Control panel fuses 7.7.3 Main engine fuses 7.8 Repair control panel components 7.8.1 Replace Selector encoder 7.8.2 Replace PC board A 7.8.3 Replace Li-battery on PC board A See next page for more

TM, elisa, CM-922280, rev. 3.03.a

7-3 7-4 7-5 7-8 7-9 7-10 7-11 7-12 7-13 7-15 7-16 7-17 7-18 7-19 7-20 7-21 7-21 7-22 7-23 7-24 7-24 7-25 7-27

7-1

7 Repair procedures

In this section (continued)

7-2

7.8.4 Replace PC board DCU 7.8.5 Replace LCD screen 7.8.6 Replace front housing with touch screen 7.8.7 Replace back cover 7.9 Repair main engine components 7.9.1 Remove back-up battery 7.9.2 Repair expiratory valve 7.9.3 Replace expiratory valve locking assembly 7.9.4 Replace expiratory valve locking spring 7.9.5 Repair inspiratory connection 7.9.6 Replace O2 sensor 7.9.7 Repair ON-Off switch 7.9.8 Replace or install On/Off switch interface PC board 7.9.9 Replace gas inlet connectors 7.9.10 Replace gas inlet filters 7.9.11 Replace pneumatic assembly 7.9.12 Replace free breathing valve 7.9.13 Replace PC board B 7.9.14 Replace alarm speaker B 7.9.15 Remove sub chassis 7.9.16 Replace transformer 7.9.17 Replace fan 7.9.18 Replace line connector 7.9.19 Replace DC mains connector 7.9.20 Replace ground connector 7.9.21 Replace serial data connector

7-28 7-29 7-30 7-31 7-32 7-32 7-33 7-34 7-35 7-36 7-37 7-38 7-39 7-40 7-41 7-42 7-43 7-44 7-45 7-46 7-47 7-48 7-49 7-50 7-51 7-52

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.1 General instructions WARNING

Post-Service Checkout is required after you complete this section. You must perform Section 3, “Post-Service Checkout”, after performing any maintenance, service or repair. Failure to do so may result in patient injury.

WARNING

When servicing the elisa CC Ventilator, extreme care must be taken to avoid introducing foreign debris, particularly metal chips generated by screw threads, into the pneumatic flow passages of the ventilator. Failure to do so may result in patient injury and damage to the flow valve.

CAUTION

Electrostatic discharge through circuit boards may damage the components on them. Wear a static control wrist wrap before touching the circuit boards

CAUTION

Handle all circuit boards by their non-conductive edges. Use anti-static containers when transporting them.

CAUTION

To avoid damaging the pressure sensors on PC board B by overpressure, caused by squeezed silicone pneumatic hoses, do not squeeze the hoses during mounting or dismounting hoses at the port of a transducer, or offset valve or hose connection.

Always touch the silicone hoses at a rigid part of the connection, such as the pressure transducer port, the offset valve port, the hose connector port.

TM, elisa, CM-922280, rev. 3.03.a

7-3

7 Repair procedures

7.2 Open the System The elisa CC Ventilator has three (3) user accessible main assemblies

The main engine

•

•

•

The control panel

The expiration valve - for Adult/Pediatric

-

for Newborn (optional)

These three assemblies can be separated by the user without using any tools. To be able to open the system remove the expiration valve assembly first, to gain access to all the three body screws. Removing the control panel is necessary to gain access to the main engine from the front side.

7-4

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.2.1 Remove the exp. valve

a) Ext. power supply is available and exp. valve control is working

The following procedures describe how to remove the expiration valve assembly of the elisa CC Ventilator when: a. external power supply is available and the ventilator is able to control the expiration valve locking mechanism. b. no external power supply is available, but the ventilator is still able to control the expiration valve locking mechanism. c. there is no power available or the ventilator is no longer able to control the expiration valve locking mechanism.

Operate the system with the external power supply.

1. 2. 3. 4. 5.

TM, elisa, CM-922280, rev. 3.03.a

Connect the system to line power. Turn ON the system. Wait for the automatic power-up test to finish. Activate button “unlock expiration valve”. Push the Selector to confirm selection.

7-5

7 Repair procedures

Note

6.

The locking mechanism releases the expiration valve assembly and the screen prompts with the following message

7.

The expiration valve can be removed from the system.

8.

When re-inserting the expiration valve, the system automatically locks the valve assembly upon proper insertion and performs a power-up test.

The re-locking of the expiration valve after re-insertion only works with an appropriate external power supply (line or DC) connected.

7-6

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

b) Ext. power supply is not available, but exp. valve control is working

c) No power available or exp. valve control does not work

Operate the system with the internal back-up battery. 1. Turn ON the system. 2. The system will prompt with an alarm message indicating that line supply is missing. 3. Activate button “unlock expiration valve” 4. Push the Selector to confirm selection. 5. The locking mechanism releases the expiration valve assembly. 6. The expiration valve can be removed from the system.

Under normal conditions, the expiratory valve assembly can be removed by selecting an option in the service menu or the system test menu. If this software function is no longer available or the locking mechanism is not functioning properly, use the following procedure to remove the expiratory valve assembly and gain access to the one housing screw. (Emergency case) 1. Remove the panel according to section 7.2.2. 2. Remove control panel mounting plate according to section 7.2.6. 3. Use a screwdriver to move up the locking mechanism of the expiratory valve by inserting it into the screw hole of the motor assembly and rotating upward. Be careful not to damage the motor or the gearbox. 4. Remove the expiratory valve.

TM, elisa, CM-922280, rev. 3.03.a

7-7

7 Repair procedures

7.2.2 Remove the control panel

To remove the control panel assembly of the elisa CC Ventilator, follow this sequence

1. Turn OFF the elisa. 2. Move the control panel to a full angled position. 3. Push down the two stainless steel rods to disengage the control panel upper locking mechanism and move the control panel forward. The upper locking mechanism is now disengaged. Hold the control panel tight. 4. Press the two locking pins of the lower locking mechanism together to release the lower locking mechanism and move the control panel forward. The lower locking mechanism is now disengaged. Hold the control panel tight. 5. Disconnect the control panel connector from the main engine and remove the control panel completely. 6. Place the control panel on the backside to not damage or scratch the touch screen. 7. To reassemble follow instruction above in reverse.

7-8

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.2.3 Open the control panel

To open the control panel of the elisa CC Ventilator, follow this sequence 1. Remove the control panel from the main engine according to section 7.2.2. 2. Remove the five screws securing the back cover and carefully remove the back cover. 3. Pay attention to the serial cable in the back cover. 4. Upon reassembly pay attention to the position of serial cable to prevent kinking of cables when mounting the back cover. 5. To reassemble follow instruction above in reverse.

TM, elisa, CM-922280, rev. 3.03.a

7-9

7 Repair procedures

7.2.4 Control panel assemblies

The open control panel of the elisa CC Ventilator.

1) 2) 3) 4) 5) 6) 7) 8) 9)

7-10

Encoder for Selector Internal serial communication port PC board, inverter, back light supply Battery for real time clock Alarm speaker A DCU board A EPROM Control panel external serial port PC board A

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.2.5. Open the main engine

To open the main engine of the elisa CC Ventilator follow this sequence: 1. 2. 3. 4. 5. 6. 7.

Turn ON the system. Remove the expiration valve according to section 7.2.1. Turn OFF the system. Disconnect the line power supply. Disconnect the gas supplies. Turn the main engine upside down. Use a 3 mm hex wrench to remove the three (3) screws in the bottom. 8. Turn main engine back on its feet. 9. Remove upper housing cover by lifting it up and back. 10. To reassemble follow instruction above in reverse.

TM, elisa, CM-922280, rev. 3.03.a

7-11

7 Repair procedures

7.2.6. Remove the control panel mounting plate

7-12

To gain access from the front side of the main engine of the elisa CC Ventilator follow this sequence: 1. Open the main engine according to section 7.2.5. 2. Remove the front panel according to section 7.2.2. 3. Remove control panel mounting plate on main engine by removing the two (2) screws in front. 4. Disconnect ground connection at the expiration valve locking assembly. 5. Disconnect the serial connection “X14” at the PC board B. 6. To reassemble follow instruction above in reverse.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.2.7 Main engine assemblies

The open main engine of the elisa CC Ventilator:

13)

1)

12)

3) 11) 4) 10)

5) 6) 7)

TM, elisa, CM-922280, rev. 3.03.a

8) 9)

7-13

7 Repair procedures

Main engine

The main engine assemblies: 1) PC board B. 2) Pneumatic assembly (below battery assembly). 3) Passive over pressure relief valve. 4) Expiration valve control assembly. 5) “Patient” tube. 6) Nebulizer port. 7) Patient connection assembly. 8) O2 sensor. 9) ON / OFF switch. 10) Line voltage selector. 11) Transformer. 12) Internal battery 13) B EPROM

Sub chassis

7-14

The sub chassis assemblies 14) Sub chassis 15) Alarm speaker B 16) Fan

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.3 Service assemblies The following are the service assemblies of the elisa CC ventilator: 1. Software service kit (A&B EPROM) 2. Control panel. a. Encoder for Selector b. Selector button (grey) c. PC board, inverter, back light supply d. Li Battery for real time clock e. Alarm speaker A f. DCU board g. PC board A h. TFT display i. Front housing with touch screen j. Rear housing with mounting system 3. Main engine a. Control panel mount. b. Expiratory valve assembly. c. Expiratory valve control assembly. d. Patient connection assembly. e. O2 sensor. f. Internal battery assembly. g. Transformer. h. PC Board “B”, w/o B EPROM. i. Pneumatic assembly. j. Fan assembly. k. Alarm speaker B. l. Line connector assembly. m. ON /OFF switch assembly. n. DC main connector assembly. o. Ground stud assembly. p. Serial data connection assembly. q. Tubing kits. r. Lower housing. s. Upper housing. For more details refer to section 8. “Illustrated Parts”.

TM, elisa, CM-922280, rev. 3.03.a

7-15

7 Repair procedures

7.4 Change the line voltage The elisa CC Ventilator is designed to run at both 230 VAC and at 115VAC, but requires internal switching to the appropriate line voltage. To change the line voltage, follow this sequence: 1. Open the main engine according to section 7.2.5. 2. Ensure that the line power supply is disconnected. 3. Ensure that the line switch is turned OFF. 4. Disconnect the main tube at the pneumatic assembly and carefully pull it forward through the space under the expiratory valve locking assembly. 5. Pull the three-position line power connector forward to disconnect it from the transformer. 6. Change the line supply connector to the desired voltage according to the following connection diagram and then reconnect it to the transformer. Be sure to align the connector so that all three pins are engaged. 230 V

115 V

7. Change the line supply fuses SI 0 a & b inside the line connector according to the line supply voltage used: - 2 x 1.6 A slow blow at 115 VAC line voltage - 2 x 0.8 A slow blow at 230 VAC line voltage For details refer to section 7.7.1. 8. Verify proper insertion of fuses and installation of the internal connector to the transformer prior to re-assembly. 9. Verify proper labeling for fuse and supply voltage.

7-16

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.5 Software replacement The elisa CC Ventilator’s software is stored in two independent EPROM’s that come together in one software service kit: • The A EPROM is located on the control panel board (PC board A). • The B EPROM is located on the main board (PC board B). When installing a new software version, verify that both EPROM’s, the A and the B, are from the same version. During the power-up test, the system compares the software revisions in both EPROM’s. If they do not match, an according message is displayed in the message box. When installing a new software version or replacing EPROM, follow these general instructions: • Always exercise proper electro static discharge (ESD) process prior and during handling of EPROM. • Always use special EPROM removing tools. • Use caution to prevent bending the EPROM pins • For the “A” EPROM mark must match the mark in PC print. • For the “B” EPROM mark must match mark of the socket. • Seat EPROM in socket properly by pushing the EPROM into the socket as deep as possible. Correct!

Wrong!

TM, elisa, CM-922280, rev. 3.03.a

7-17

7 Repair procedures

7.5.1 Change the (A) EPROM

Following languages are available in the software of the elisa CC ventilator. a) b) c) d) e) f) g) h) i)

English German Polish Spanish French Italian Portuguese Dutch Turkish

The language part of the software is stored in the A EPROM. There is one A EPROM for all languages, because language selection is made via the configuration menu. See chapter 10 for more details To replace the A EPROM: 1. Ensure that the system is turned OFF and line power is disconnected. 2. Remove control panel from main engine according to section 7.2.2. 3. Open control panel according to section 7.2.3. 4. Use a chip extractor to remove the current A EPROM. 5. Insert the new A EPROM (mark facing the panel housing). 6. Verify that the EPROM is properly inserted. To verify proper function, turn ON the system and perform the power-up test. To configure desired language see chapter 10 for more details.

7-18

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.5.2 Change the main (B) EPROM

To replace the B EPROM follow the instruction below: 1. Ensure that the system is turned OFF and line power is disconnected. 2. Open main engine according to section 7.2.5. 3. Use a chip extractor to remove the current B EPROM. 4. Insert the new B EPROM (mark toward the left side). 5. Verify that the EPROM is properly inserted.

To verify proper function, turn ON the system and perform the power-up test. .

TM, elisa, CM-922280, rev. 3.03.a

7-19

7 Repair procedures

7.6 Change the units of pressure The elisa CC ventilator allows changing the units of pressure via the configuration menu. For more details see chapter 10.

7-20

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.7 Change fuses The elisa CC ventilator’s electronic system is protected by several fuses, indicated in the overview diagrams (see section 9). The fuses are located: • • •

in the line connector (SI O a and b) on PC board A ( SI 1 - SI 4) on PC board B (SI 10 - SI 41).

Always use the identical type and rating when replacing a fuse. For details see list of fuses in section 9.7.

7.7.1 Line fuses

To replace the line fuses inside the line connector, located on the back side of the main engine, follow this sequence: 1. Ensure that the system is turned OFF and line power is disconnected. 2. Remove line power cord from line connector. 3. Using a small screwdriver open the two clamps of the fuse compartment and pull it out carefully. The fuses are located in a spring loaded mechanism for easy replacement. 4. Replace fuses according to the line voltage used - 2 x 1.6 A slow blow at 115 VAC line voltage. - 2 x 0.8 A slow blow at 230 VAC line voltage. 5. Reinsert fuse compartment with the black nose facing downwards and apply gentle pressure until both clamps lock in place. 6. Verify proper function by connecting the system to line supply, turning the mains switch to ON, and confirming that the green ON-OFF button on the front of the unit is illuminated. 7. If the fuse blows again, analyze the reason prior to another replacement of fuses.

TM, elisa, CM-922280, rev. 3.03.a

7-21

7 Repair procedures

7.7.2 Control panel fuses

The elisa CC ventilator’s control panel is protected by the following fuses: (in order from left to right) a) b) c) d) e)

Caution

Important note

SI 381 = + 5V controller voltage = 1.6 A slow blow. SI 380 = control panel voltage input = 0.8 A slow blow. SI 300 = LCD Backlight supply = 0.8 A slow blow. SI 2 = Alarm horn supply = 0.315 A slow blow. SI 1 = battery supply = 0.032 A fast blow. (Resistor)

Do not replace a blown fuse. For safety reasons in case of a blown fuse always replace the PC board A.

These fuses care for a fail safe mode of the micro A device in case of a malfunction. In all known cases of a blown fuse parts of the electronic of PC board A were causing it. These defective parts on PC board A needs to be evaluated prior to re-activating the board into operation. In case of replacing the fuse without investigating the cause of the over current it must be estimated that a defective electronic part of PC board A either may cause the fuse to blown again or may cause a malfunction of the device later again. With PC board A HW versions g and up these fuses are of a nonchangeable type. To replace the PC board A follow the sequence described in section 7.8.2.

7-22

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.7.3 Main engine fuses

Note

The elisa CC ventilator’s main engine is protected by the following fuses that are all located on the PC board B: • SI 10 = Alarm speaker B = 0.315 A slow blow. • SI 11 = Fan = 0.315 A slow blow. • SI 21 = Transformer secondary 1 = 3.15 A slow blow. • SI 22 = Transformer secondary 2 = 3.15 A slow blow. • SI 23 = Line 24 V DC inlet = 3.15 A slow blow. • SI 24 = Back-up battery = 3.15 A slow blow. • SI 25 = Battery charger = 0.5 A slow blow. • SI 26 = + 13 V bus = 3.15 A slow blow. • SI 27 = + 15 V bus = 3.15 A slow blow. • SI 28 = + 5 V bus = 0.5 A slow blow. • SI 29 = isolated power supply (serial) = 0.315 A slow blow. • SI 41 = Exp. Valve heater = 1.0 A slow blow. Always use the identical type and rating when replacing a fuse. For details see list of fuses in section 9.7. To replace the fuses on the PC board B inside the main engine follow this sequence: 1. Open the main engine according to section 7.2.5. 2. Disconnect the back-up battery connector X23. 3. Replace fuse. 4. Verify proper function after reassembly by performing a power-up test. 5. If the fuse blows again, analyze the reason prior to another replacement of fuses. For location details of fuses refer to the component print of PC board B in section 9.

Note

It is necessary to remove the battery according to section 7.9.1 to access SI 10, SI 11, SI 25, SI 28 and SI 29. Replacement of these fuses requires the use of long nose pliers.

TM, elisa, CM-922280, rev. 3.03.a

7-23

7 Repair procedures

7.8 Repair control panel components 7.8.1 Replace Selector encoder

To replace the elisa´s control panels Selector follow this sequence: Remove the control panel according to section 7.2.2. Open the panel according to section 7.2.3. Remove the Selector knob. Unplug the Selector encoder connector. Use a 14 mm wrench to remove the Selector nut. Remove the Selector encoder from the panel. Insert the new Selector encoder and reassemble as shown in the picture with the washer on the inner side of the control panel front housing. 8. Place the spring washer below the encoder nut on the outside of the control panel front housing and carefully fix the nut using the 14 mm wrench. 9. Reconnect the encoder connection. 10. Close the panel according to section 7.2.3. 11. Place the Selector button onto the encoder. Pay attention that the cut in the Selector button matches the cut on encoder axis. 12. Verify proper function after reassembly by performing a power-up test. 1. 2. 3. 4. 5. 6. 7.

7-24

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.8.2 Replace PC board A

Option menu Serial number Option key

19000000 12345678

Option menu Serial number Option key

190xxxxxx 12345678

Important Note

Option menu Serial number Option key

190xxxxxx

To replace the PC board A, follow this sequence: 1) Remove the control panel according to section 7.2.2. 2) Open the panel according to section 7.2.3. 3) Disconnect main engine connector and remove rear housing. 4) Disconnect encoder connector, screen back light connector and touch screen connector, TFT screen connector. 5) Unscrew the serial connector and remove plug carefully from front housing. 6) Unscrew the three metal screws at the PC board’s corners. 7) Unscrew the one nylon screw to loosen the PC board A. 8) Remove the PC board A. 9) Note that BE-121052 (PC board A) comes w/o A EPROM, w/o PC board DCU, w/o PC board inverter, w/o inverter cable, w/o alarm speaker A and w/o lithium battery. Remove those components from old PC board A and insert into new PC board A, if applicable. 10) Remove the sticker with the service clearance key for later serialization from the PC board A prior to mounting and keep it in a safe place. 11) Insert the new PC board A, and fix the three metal screws. 12) Fix the one nylon screw at the encoder. 13) Reconnect encoder, back light, touch screen, TFT screen. 14) Reconnect main engine connector and mount the rear housing with the six screws. 15) Turn ON the elisa. 16) During Power up test the system will recognize the fact, that the lithium battery was replaced and an alarm will notify the user with the following message. 17) Accept the message by pressing the accept button. 18) Watch the system now performing the standard power-up test. 19) Run a complete system test and verify proper operation of the system. 20) Perform five (5) system tests successfully to rewrite all storage levels in the A EEPROM.

12345678

TM, elisa, CM-922280, rev. 3.03.a

7-25

7 Repair procedures

21) A spare part PC board A comes without a specific serial number on the EEPROM and allows for one time to be serialized after installation. This one time serialization needs no additional codes etc, but only works for one time per service PC board A. 22) Serialize the new PC board A according to the following sequence: a) Start elisa and wait for the power-up test to finalize. b) Start the optionalization mode according to section 10.2.1. c) Move the frame to the serial number area. Note that the serial number is “19000000”. Carefully enter the elisa serial number (serial plate, rear side of main engine) according to the procedure described in section 10.2.2. 23) Verify proper serial number entering prior to activating the “Save” button. a) Move the frame to the option key area and enter the elisa released options (option key sticker, rear side of control panel) according to section 10.2.2, if applicable. b) Verify proper optionalization according to section 10.2.

Special notice

7-26

Note that when pressing the “Save” button once the serial number cannot be changed anymore.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.8.3 Replace Li-battery on PC board A

The Lithium battery buffering the flash RAM and the real time clock on PC board A needs to be replaced every 5 years. To replace the Lithium battery on PC board A, follow this sequence: 1) Remove the control panel according to section 7.2.2. 2) Open the panel according to section 7.2.3. 3) Disconnect main engine connector and remove rear housing. 4) Cut tie wrap of Lithium battery and carefully remove tie wrap from PC board A. 5) Remove Lithium battery from battery bracket. 6) Insert new Lithium battery into battery bracket. Watch for correct polarity prior to inserting! 7) Fix battery with a tie wrap. To ease inserting the tie wrap into the two wholes on PC board A bend the end of the tie wrap as shown in the picture. 8) Reconnect main engine connector and mount the rear housing with the six screws. 9) Mount control panel to main engine according to section 7.2.2. 10) Turn ON the elisa. 11) During Power up test the system will recognize the fact, that the lithium battery was replaced and an alarm will notify the user with the following message. 12) Accept the message by pressing the accept button. 13) Watch the system now performing the standard power-up test. 14) Run a complete system test and verify proper operation of the system.

TM, elisa, CM-922280, rev. 3.03.a

7-27

7 Repair procedures

7.8.4 Replace PC board DCU

To replace the PC board DCU, follow this sequence:

1. 2. 3. 4. 5. 6. 7. 8. 9.

7-28

Remove the control panel according to section 7.2.2. Open the panel according to section 7.2.3. Disconnect main engine connector and remove rear housing Carefully lift PC board DCU from its two PC connectors. Squeeze the nylon board secure lock to allow removing the CDU board Insert the new PC board DCU into the nylon board secure lock and onto the two PC connectors Push DCU board carefully to secure PC connection. Close panel. Verify proper function after reassembly by performing a power-up test.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.8.5 Replace LCD screen

To replace the LCD screen with integrated back lights, follow this sequence:

1. 2. 3. 4. 5. 6. 7. 8. 9.

TM, elisa, CM-922280, rev. 3.03.a

Remove the control panel according to section 7.2.2. Open the panel according to section 7.2.3. Remove PC board A according to section 7.8.2. Unscrew the four chassis bolds, using a 5 mm wrench. Carefully remove the TFT screen. Insert a new TFT LCD screen. Carefully adjust the bolds. Reassemble the PC board A according to section 7.8.2. Verify proper function after reassembly by performing a power-up test.

7-29

7 Repair procedures

7.8.6 Replace front housing with touch screen

To replace the front housing with integrated touch screen and EMI screen, follow this sequence:

1. 2. 3. 4. 5. 6. 7. 8.

7-30

Remove the control panel according to section 7.2.2. Open the panel according to section 7.2.3. Remove PC board A according to section 7.8.2. Remove TFT screen according to section 7.8.4. Replace front housing with touch screen and EMV screen. Reassemble TFT screen according to section 7.8.4. Reassemble the PC board A according to section 7.8.2. Verify proper function after reassembly by performing a power-up test.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.8.7 Replace back cover

To replace the back cover of the control panel of the elisa CC Ventilator, follow this sequence 1. Remove the control panel from the main engine. according to section 7.2.2 2. Remove the five screws securing the back cover and carefully remove the back cover. 3. Disconnect the serial cable in the back cover. 4. Remove serial plate from old cover and place it to the new back cover. 5. Replace back cover with serial cable. 6. Upon reassembly pay attention to the position of serial cable to prevent kinking of cables when mounting the back cover. 7. To reassemble follow instruction above in reverse. 8. Verify proper function after reassembly by performing a power-up test.

TM, elisa, CM-922280, rev. 3.03.a

7-31

7 Repair procedures

7.9 Repair main engine components 7.9.1 Remove back-up battery

The elisa CC Ventilator is equipped with a built-in back-up battery that is designed to provide a minimum of 30 minutes of battery operation. To remove or replace the battery assembly MA-630020 follow this sequence: 1. Open the main engine according to section 7.2.5. 2. Remove the control panel mounting plate according to section 7.2.6. 3. Use a 7 mm nut driver to remove the two stop nuts left and right of the battery. 4. Remove the battery from the battery bracket. If replacing the back-up battery, disconnect X 23. 5. Use a 7 mm nut driver to loosen the two stop nuts mounting the battery bracket to the transformer assembly. Do not remove the nuts from the bolts. 6. Shift the battery bracket backwards to center the stop nuts with the large bore. 7. Lift the battery bracket up to remove. 8. For some calibration procedures, the back-up battery assembly is removed to allow better access to PC board B. In those cases, the back-up battery must stay connected to PC board B. 9. If replacing the entire assembly screw the two stop nuts M4 to the transformer bolts with several turns. 10. Insert the new battery bracket with the stop nuts facing the large bore in the bottom of the bracket. 11. Move the battery bracket forward to center the stop nuts with the small bore. 12. Use a 7 mm nut driver to fix the stop nuts to the battery bracket while carefully pulling the bracket forward to center the stop nuts properly with the small bore while fastening. 13. Insert the battery block onto the battery bracket with its cable and connectors facing the PC board B. 14. Fix the battery to the battery bracket with the two stop nuts by using a 7 mm nut driver. 15. Connect the battery connector X 23 to the PC board B. 16. Mount the control panel plate. 17. Close the main engine. 18. Verify proper function after reassembly by performing a power-up test.

Note

7-32

Pay attention not to pinch or damage cables or tubes when reassembling the battery. TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.2 Repair expiratory valve

The elisa CC Ventilator is equipped with an expiration valve locking mechanism that uses a motor driven locking system to properly fix the expiration valve inside the system. To repair and inspect expiration valve: 1. Remove the expiration valve according to section 7.2.1. 2. Remove membrane plate (1) to gain access to the PEEP membrane assembly (2). 3. Remove the PEEP membrane assembly (2) from the base of valve (3) and replace membrane. 4. In case the PEEP membrane assembly (2) is apart, lock the PEEP membrane assembly together by inserting the silicon lock at the PEEP top seal membrane (2a) through the PEEP PSU plate (2b) (cut edge facing 2c) and then through the PEEP silicone membrane (2c). Pull on the lock until the locking lip is fully engaged. 5. Insert the PEEP membrane assembly into the expiration valve with the sealing membrane (2c) facing down. The side of the top seal (2a) marked “top” should be facing the top. 6. Inspect and clean flow measurement port. 7. Replace and grease o-ring (5) at flow measurement port. 8. Remove the flow screen retainer (8) by turning the retainer counterclockwise; retainers with visible slot can be removed by using steel membrane plate (1); retainers without visible slot can be removed using the inspiration connection tool included in tool kit ST 4 ( see page 8-3) 9. Carefully remove the flow screen (7) and o-ring (6). 10. Insert o-ring (6) and the flow screen (7). 11. Reinstall the flow screen retainer (8) by turning retainer clockwise. 12. Verify proper function after reassembly by performing a system test.

TM, elisa, CM-922280, rev. 3.03.a

7-33

7 Repair procedures

7.9.3 Repair expiratory valve locking assembly

The elisa CC Ventilator is equipped with an expiration valve locking mechanism that uses a motor driven locking system to properly fix the expiration valve inside the system. To remove the expiration valve locking assembly: 1. Remove the expiration valve according to section 7.2.1. 2. Remove the control panel according to section 7.2.2. 3. Remove the control panel mounting plate according to section 7.2.6. 4. Open the main engine according to section 7.2.5. 5. Remove back-up battery according to section 7.9.1. 6. Disconnect X 42 on PC board B. 7. Disconnect the ground connection at the front of the assembly. 8. Disconnect tube A from the expiration valve locking assembly (left side). NOTE: Check caution note in section 7.1. ! 9. Disconnect “patient” tube at the inspiratory connection. 10. Unscrew three screws at the bottom of the assembly, one on the left side, two on the right side. 11. Remove the entire assembly by lifting it up and to the right. 12. When inserting the assembly, place the three screws into the assembly before placing it into the system. 13. Fix the three screws at the bottom of the assembly. 14. Reconnect “patient” tube at the inspiratory connection. 15. Reconnect tube A to the expiration valve locking assembly. NOTE: Check caution note in section 7.1. ! 16. Reconnect the ground connection at the front of the assembly. 17. Reconnect X 42 on PC board B. 18. Insert back-up battery according to section 7.9.1. 19. Close the main engine; add the control panel and expiratory valve. 20. Verify proper function after reassembly by performing a power-up test.

7-34

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.4 Replace expiratory valve locking spring

The elisa expiration valve locking mechanism uses a spring to secure the valve mechanism position. To remove the expiration valve locking spring: 1. 2. 3. 4.

Remove the expiration valve according to section 7.2.1. Remove the control panel according to section 7.2.2. Open the main engine according to section 7.2.5 Remove the control panel mounting plate according to section 7.2.6 5. Move down the locking mechanism of the expiratory valve using a screwdriver inserted into the screw hole of the motor assembly 6. Carefully rotate downwards. Important note

Be careful not to damage the motor or the gearbox! 7. Remove the screws and then the mounting plate. 8. Replace the flat spring.

Important note

Ensure that the cables are placed correctly in the cable run! 9. Re-assemble the control panel mounting plate according to section 7.2.6 10. Close the main engine according to section 7.2.5 11. Re-assemble the control panel according to section 7.2.2. 12. Re-insert the expiration valve. The re-locking of the expiration valve after re-insertion only works on condition that an appropriate external power supply (line or DC) is connected

Verify proper function after re-assembly by performing a power-up and system test. Perform “Post service checkout” according to section 3

TM, elisa, CM-922280, rev. 3.03.a

7-35

7 Repair procedures

7.9.5 Repair inspiratory connection

The inspiratory connection assembly includes the O2 sensor, the connection to the pneumatic assembly and the connection to the pressure measuring port. To replace the inspiratory connection assembly: 1. Remove the expiration valve according to section 7.2.1. 2. Remove the control panel according to section 7.2.2. 3. Remove the control panel mounting plate according to section 7.2.6. 4. Open the main engine according to section 7.2.5. 5. Disconnect cable X 31 at the O2 sensor connection. 6. Disconnect “patient” tube of pneumatic assembly at the inspiratory connection. 7. Use the “inspiratory connection nut” from ST 5 to unscrew the black front nut of the inspiratory connection. 8. Remove the inspiratory connection from the housing. 9. Disconnect tube B (patient pressure line) from the inspiratory connection. NOTE: Check caution note in section 7.1. ! 10. Upon re-inserting the inspiratory connection, pay attention to match the inner housing of the inspiratory connection with the anti-turn of the lower cabinet. 11. Reconnect tube B from the inspiratory connection. NOTE: Check caution note in section 7.1. ! 12. Use the “inspiratory connection nut” from ST 5 to fix the black front nut of the inspiratory connection. 13. Reconnect cable X 31 at the O2 sensor connection. 14. Close the main engine; add the control panel and expiratory valve. 15. Verify proper function after reassembly by performing a power-up test.

7-36

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.6 Replace O2 sensor

The O2 sensor is located within the inspiratory connection assembly. To replace the O2 sensor: 1. Remove the control panel according to section 7.2.2. 2. Remove the control panel mounting plate according to section 7.2.6. 3. Disconnect X 31 at the O2 sensor connection. 4. Remove the O2 sensor from the inspiratory connection assembly by turning it counterclockwise. 5. Replace the O2 sensor and verify that the red seal is properly positioned between the O2 sensor and the inspiratory connection. Do not use a tool; fasten with medium hand power only. 6. Reconnect X 31 at the O2 sensor connection. 7. Insert the panel mounting plate according to section 7.2.6. 8. Insert the control panel according to section 7.2.2. 9. Allow the new O2 sensor to stabilize for approximately 5 minutes in room air prior to calibration. 10. After reassembly, perform an O2 calibration according to section 4.7.1.

CAUTION

Use only genuine spare parts when replacing O2 sensor.

TM, elisa, CM-922280, rev. 3.03.a

7-37

7 Repair procedures

7.9.7 Repair ONOFF switch

The ON-OFF switch is located on the right lower side of the front. The ON-OFF switch is illuminated whenever the system is supplied by main supply and the line switch on the back of the unit is turned ON. To repair the light or the cover: 1. Turn OFF the system. 2. Remove the green cover (1) by inserting a small screwdriver into the cover slot and pulling forward. 3. Remove the white diffuser (2) with a small screwdriver. 4. Remove the bulb/LED (3) from switch body (4) with a 2 mm silicon tube or small pliers. 5. Replace bulb/LED and reinsert white diffuser (3) and green cover (2). To replace the entire ON-OFF switch: 1. Remove the expiration valve according to section 7.2.1. 2. Remove the control panel according to section 7.2.2. 3. Remove the panel mounting plate according to section 7.2.6. 4. Open the main engine according to section 7.2.5. 5. Disconnect X 24 at PC board B. 6. Unscrew the plastic nut (5) on the inside of the housing. 7. Slide the nut over the switch body (4), cable and connector. 8. Pull the ON-OFF switch out from the front and replace. 9. Slide the nut over the switch body (4), cable and connector. 10. Fix the plastic nut (5) on the inside of the housing. Note that the slotted end of the nut is toward the front. 11. Reconnect X 24 at PC board B. 12. Close the main engine; add the control panel and expiratory valve. 13. Verify proper function after reassembly by performing a power-up test.

CAUTION

7-38

elisa must be disconnected from AC- main supply. Possible risk of short-circuit when using metal tools when replacing bulb/LED. Switch OFF the main switch on the rear side and unplug the AC power cable.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.8 Replace or install On/Off switch interface

The On/Off switch interface PC board is an additional control system for the On/Off switch and is placed between B board and back up battery:. 1. 2. 3. 4. 5. 6.

PC board

Turn OFF the system Remove the expiration valve according to section 7.2.1. Open the main engine according to section 7.2.5 Disconnect cables X15 and X24 Remove and discard nut. Take the washer out of the kit and put it on the thread of the B-board mounting stud. 7. Take the hex standoff out of the kit and screw it on to the Bboard mounting stud. 8. Insert the On/Off switch interface PC board on to the hex standoff in a position, that cable X15 is on the right side. 9. Secure the On/Off switch interface PC board with the nylok nut. 10. Connect cables X15 and X24 from the elisa cable set to the On/Off switch interface PC board. 11. Connect the cables X15 and X24 of the On/Off switch interface PC board to the according connectors on the PC board B of elisa. 12. Close the main engine according to section 7.2.5. 13. Re-assemble the control panel according to section 7.2.2. 14. Re-insert the expiration valve. 15. Verify proper function after reassembly by performing a power-up and a system test.

TM, elisa, CM-922280, rev. 3.03.a

7-39

7 Repair procedures

7.9.9 Replace gas inlet connectors

The pneumatic inlet has two gas connections, one for AIR and one for O2. To match connector needs of different standards these gas connections can be exchanged without opening the main engine. To replace the gas inlet connectors: 1. Turn the unit upside down. 2. Use a 22 mm wrench to unscrew the gas connector for AIR first. 3. Use a 22 mm wrench to unscrew the gas connector for O2. 4. Replace gas connector and first screw connector for O2.

Note

Caution

7-40

Check that the gas inlet filters are properly seated. There are different gas inlet connector standards available (NIST, DISS f, DISS m, S90-116, G 3/8 BSPP)

Ensure that gas connector type matches correct gas inlet type. (AIR – AIR, O2 – O2) The gas connector type is marked accordingly.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.10 Replace gas inlet filters

Each of the gas inlets has a sinter filter to protect the pneumatic assembly from foreign material. If the filter's resistance is increased due to debris, the system will alarm with a message during system test to clean the filter element. To replace the filter: 1. Remove the gas inlet connector according to section 7.9.9. 2. Remove and replace the gas filter from the gas connector.

Note

Note that the filter for AIR and O2 are identical.

TM, elisa, CM-922280, rev. 3.03.a

7-41

7 Repair procedures

7.9.11 Replace pneumatic assembly

The pneumatic assembly contains the four inspiratory valves, the flow control for O2 and AIR, the gas supply pressure sensors, the passive and the active overpressure relieve valve, the free breathing valve and the pneumatic PC board with temperature sensor. To remove the pneumatic assembly: 1. 2. 3. 4.

Remove the gas inlet connector according to section 7.9.9. Remove the expiration valve according to section 7.2.1. Remove the control panel according to section 7.2.2. Remove the control panel mounting plate according to section 7.2.6. 5. Remove the expiratory valve locking assembly according to section 7.9.3. 6. Remove battery assembly according to section 7.9.1. 7. Remove the “patient” tube from the pneumatic assembly. 8. Disconnect the nebulizer tube at the nebulizer front connection. 9. Disconnect the flow measurement tubes C/C’ and D/D’ at the tube connectors. NOTE Check caution note in section 7.1. ! 10. Disconnect the common “ambient” tube of pressure sensors on the pneumatic assembly. NOTE: Check caution note in section 7.1. ! 11. Disconnect the flat cable X 44 on PC board B. 12. Disconnect ground connection at common ground on sub chassis. 13. Disconnect the transformer connector according to section 7.4. 14. Unscrew the one mounting screw of the pneumatic assembly. 15. Remove the pneumatic assembly by lifting it up about 4 mm and then pull gently forward. 16. Reassemble by following the instructions above in reverse. The pneumatic assembly is tightly fitted within the assemblies. Remove it carefully. To ease lifting either unscrew the transformer power connector from the sub chassis or carefully bend the transformer power connector 2 mm to the right. Reassembly of the common ground connection requires a contact washer between sub chassis and first connector and a spring washer between the last connector and the nut.

7-42

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.12 Replace free breathing valve

The free breathing valve is mounted on the pneumatic assembly. To remove the free breathing valve: 1. Remove the pneumatic assembly according to section 7.9.11. 2. Disconnect the active pressure relief valve connector X8 from the pneumatic assembly PC board. 3. Unscrew the two screws to remove the passive overpressure relief valve solenoid. 4. Remove the solenoid moving core from the rod. 5. Turn the pneumatic assembly upside down. 6. Unscrew the four screws of the free breathing valve retainer. 7. Remove the free breathing valve retainer and the free breathing valve from the pneumatic assembly. 8. While inserting the free breathing valve pay attention to proper seating. Incorrect seating (e.g. with incorrect tension on the valve’s silicon springs) can cause leaks. 9. Insert the free breathing valve retainer and fix it with the four screws. 10. Add the solenoid moving core to the rod. 11. Fix the two screws of the passive over pressure relief valve solenoid. 12. Reconnect the active pressure relief valve connector X8 to the pneumatic assembly PC board.

Note

The stainless steel rod, that is connects with the over pressure relief valve, opens the free breathing valve when activated. Ensure free moving of the rod after reassembly of the over pressure relief valve.

TM, elisa, CM-922280, rev. 3.03.a

7-43

7 Repair procedures

7.9.13 Replace PC board B

The PC board B is located on the sub chassis. To replace the PC board B: 1. Remove the control panel according to section 7.2.2. 2. Remove the control panel mounting plate according to section 7.2.6. 3. Open the main engine according to section 7.2.5. 4. Remove back-up battery according to section 7.9.1. 5. Disconnect electrical connectors X 21, X 22, X23, X 10, X15, X16, X 24, X 31, X 42 and X 44. 6. Disconnect exp. flow measuring tube A at the expiratory valve control assembly. 7. Disconnect pressure measuring tube B at the tube connector. 8. Disconnect flow measurement tubes C/C’ and D/D’ at the tube connectors. 9. Disconnect “ambient” tube for the pressure transducers at the T-piece towards the pneumatic assembly. 10. Unscrew the three nuts (top left, top middle and top right), fixing the PC board B to the sub chassis with a 5.5 mm wrench. 11. Remove the PC board B by lifting it forward and up. 12. Replace the PC board B and fix the three nuts. 13. Reconnect “ambient” tube, flow measurement tubes C/C’ and D/D’, pressure measuring tube B and exp. flow measuring tube A. 14. Reconnect electrical connectors X 21, X 22, X23, X 10, X15, X16, X 24, X 31, X 42 and X 44. 15. Perform all calibrations according to section 4.7.1 to 4.7.8 16. Insert back-up battery according to section 7.9.2. 17. Close the main engine; add the control panel and expiratory valve. 18. Perform five (5) system tests successfully to rewrite all storage levels in the B EEPROM.

Important note

7-44

Check caution note in section 7.1.!

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.14 Replace alarm speaker B

The alarm speaker B is located on the rear of the sub chassis. To replace the alarm speaker: 1. Open the main engine according to section 7.2.5. 2. Unplug alarm speaker connector X 16. 3. Remove the two mounting screws of the alarm speaker on the back panel. 4. Replace the alarm speaker. 5. Mount the alarm speaker with a spacer per screw between sub chassis and alarm speaker, the cable towards the middle of the sub chassis. 6. Connect the alarm speaker connector X 16. 7. Close the main engine, add expiratory valve. 8. Verify proper function after reassembly by performing a power-up test.

TM, elisa, CM-922280, rev. 3.03.a

7-45

7 Repair procedures

7.9.15 Remove sub chassis

The sub chassis contains the PC board B, the alarm speaker B, the transformer assembly and the fan. To replace fan or transformer the sub chassis must be removed. The sub chassis must also be removed to gain access to the rear connectors (AC mains connector, DC mains connector, ground connector, serial connector). To remove the sub chassis: 1. Remove the control panel according to section 7.2.2. 2. Remove the control panel mounting plate according to section 7.2.6. 3. Open the main engine according to section 7.2.5. 4. Remove back-up battery according to section 7.9.1. 5. Remove the expiratory valve locking assembly according to section 7.9.3. 6. Disconnect electrical connectors X 21, X 22, (X23), X 10, X15, X16, X 24, X 31, (X 42) and X 44. 7. Loose tape fixing of cable X 10 on rear side of sub chassis. 8. Use a 7 mm nut driver to remove the common ground and disconnect all ground lines from the sub chassis. 9. Disconnect the transformer connector according to section 7.4. 10. Disconnect pressure measuring tube B at the tube connector. 11. Disconnect flow measurement tubes C/C’ and D/D’ at the tube connectors. 12. Disconnect “ambient” tube for the pressure transducers at the T-piece towards the pneumatic assembly. 13. Disconnect the “patient” tube at the inspiratory connection to gain better access to the front left sub chassis fixing nut. 14. Use a 7 mm nut driver to remove the two nuts left and right in front of the transformer and the two nuts left and right behind the transformer. 15. Lift the back of the sub chassis and move it up and forward. 16. Reassemble by following the instructions above in reverse.

Note

7-46

Reassembly of the common ground connection requires a contact washer between sub chassis and first connector and a spring washer between the last connector and the nut.

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.16 Replace transformer

The transformer is mounted on the sub chassis. To remove the transformer: 1. 2. 3. 4. 5. 6. 7. 8. 9.

TM, elisa, CM-922280, rev. 3.03.a

Remove the sub chassis according to section 7.9.15. Disconnect the three primary wires at the line connector. Use a 7 mm wrench to unscrew the two nuts in front. Use a 7 mm nut driver to unscrew the one nut in the back of the transformer. Replace the transformer. When mounting the transformer keep the cables on the proper side (left side seen from the front). Fix the three nuts. Reconnect the three primary wires at the line connector. Connect the primary wires with the black lead in the center position.

7-47

7 Repair procedures

7.9.17 Replace fan

The fan is located on the sub chassis. To remove the fan: 1. 2. 3. 4.

Remove the sub chassis according to section 7.9.15. Unscrew the four screws with stop nuts. Replace the fan. When mounting the fan keep the cable on the proper side (towards the inside) and the airflow indicator arrow on the fan pointing down. 5. Fix the fan screws with stop nuts.

7-48

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.18 Replace line connector

The line connector is located on the rear of the main engine. To replace the line connector: 1. 2. 3. 4. 5.

Note

Remove the sub chassis according to section 7.9.15. Bend the top and bottom plastic locks together. Remove the line connector to the outside. Replace the line connector. When replacing the line connector, be sure to have the switch at the top and remember to insert the proper line fuses according to the selected line voltage.

The line cable ferrite needs to be placed according to the photo to allow the sub chassis to be mounted properly.

TM, elisa, CM-922280, rev. 3.03.a

7-49

7 Repair procedures

7.9.19 Replace DC main connector

The DC main connector is located on the rear of the main engine. To replace the DC mains connector: 1. Remove the sub chassis according to section 7.9.15. 2. Disconnect the wires from connector X 22. 3. Use a 17 mm wrench to remove the nut from the connector on the inside of the housing. 4. Remove the DC mains connector to the outside. 5. Replace the DC mains connector. 6. When replacing the DC mains connector be sure to reconnect the wires to connector X 22 in the proper order.

4

orange

5

red

6

7-50

X 22

blue

TM, elisa, CM-922280, rev. 3.03.a

7 Repair procedures

7.9.20 Replace ground connector

The ground connector is located on the rear of the main engine. To replace the ground connector: 1. 2. 3. 4. 5.

TM, elisa, CM-922280, rev. 3.03.a

Remove the sub chassis according to section 7.9.15. Use a 10 mm wrench to remove the nut from the connector. Remove the ground connector to the outside. Replace the ground connector. When replacing the ground connector, be sure to mount the outside label prior to reinsertion properly.

7-51

7 Repair procedures

7.9.21 Replace serial data connector

Important note

7-52

The serial data connector is located on the rear of the main engine. To replace the serial data connector: 1. Remove the sub chassis according to section 7.9.15. 2. Use a 5 mm nut driver to remove the nuts from the serial data connector. 3. Remove the serial data connector to the outside. 4. Replace the serial data connector.

Upon reinstallation, pay attention to have the small side of the D sub 9 facing down.

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated Parts

In this section

8.1 Special instructions 8.2 Service tools 8.2.1 Calibration accessories kit, ST 2 8.2.2 Test lung kit, ST 3 8.2.3 “Service” flow screen ST5 8.2.4 Tool kit, ST 4 8.2.5 Test equipment specifications 8.2.6 Service cable 8.2.7 Service kit 8.3 Software 8.3.1 Software kit 8.4 Control panel spare parts 8.5 Expiration valve spare parts 8.6 Main engine spare parts

TM, elisa, CM-922280, rev. 3.03.a

8-2 8-2 8-2 8-2 8-2 8-3 8-3 8-4 8-4 8-5 8-5 8-6 8-12 8-14

8-1

8 Illustrated parts

8.1 Special instructions Apply a thin coat of oxygen-use-approved lubricant to o-rings prior to installation (unless otherwise noted). When replacing fittings, position the barb end in the same direction as the original fitting to make the routing and connection of tubing easier.

8.2 Service tools 8.2.1 Calibration accessories kit, ST 2

8.2.2 Test lung kit ST 3

Note Note

8.2.3 “Service” flow screen ST 5

8-2

The calibration accessories kit (P/N MA-640008) consists of • 2 x 22 mm corrugated tube, 15” • 22 mm sealer.

The test lung kit (P/N AZ-381501) consist of • Test lung with built in resistor, Vt range = 50 – 500 ml R approx. 15 – 25 cmH2O/l/s, , C approx. 10 - 30 ml/cmH2O • Filter This test lung kit is used for servicing the elisa ventilator. Test lungs with different compliance and resistance characteristics may not match test lung related data in this service manual. A minimum resistance of 5 cmH2O/l/s is required.

The “Service” flow screen is a flow screen with tolerance “± 0.49%”, used for calibration of the expiratory flow sensor according to chapter 4.7.5.The flow screen comes in a plastic protection case.

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

8.2.4 Tool kit ST 4

The tool kit (P/N MA-640007) consist of • Pozidrive, screw driver, PH L1 • Inspiration connection nut • Nut driver, size M 7 • Allen wrench, size M 3 • Nut driver, size M 5.5 • Nut driver, size M 20/22 • Tightening key • Calibration screw driver • EPROM grip • Tool bag This tool kit is designed for field service. Other tools can be used as long as their sizes match the above.

8.2.5 Test equipment specifications

Instrumentation used to service the elisa Ventilator must meet or exceed the following specifications: • Pressure meter • Pressure range 0 – 90 cmH2O • Accuracy ± 0.1 cmH2O • Flow meter • Flow range 0 – 150 L/Min • Accuracy ± 0.05 L/Min or 2% of reading, • Calibrated for AIR and O2 • Multi meter • Type Standard multi meter • Parameter VAC, VDC, AAC, ADC, Ohm • Accuracy ± 1%

TM, elisa, CM-922280, rev. 3.03.a

8-3

8 Illustrated parts

8.2.6 Service cable

8.2.7 Service kit

8-4

To download the service log (event log and trend data) the service cable (P/N BE-126081) has to be connected between the front panel and the PC or Laptop.

Pos 1 2 3

Order Number MA-640020 MA-640021 MA-640022

Description elisa Service kit 12 months elisa Service kit 24 months elisa Service kit 60 months

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

8.3 Software 8.3.1 Software service kit

Pos Order Number Description 1 BZ-529351 elisa EPROM kit The software service kit provides the latest released software revision and contains one set of A & B EPROM’s.

TM, elisa, CM-922280, rev. 3.03.a

8-5

8 Illustrated parts

8.4 Control panel spare parts Mounting bracket

Front housing

8-6

Pos Order Number Description 1 BM-352435 Control panel mounting bracket 2 DB-449133 Screw M5 x 10 (not shown, 2 required)

Pos Order Number Description 1 MA-352416 Front housing with mounted front folio with mounted touch screen with mounted EMV shield without encoder

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Selector

PC board DCU

Pos Order Number 1 CW-769174 CW-769175 2 ES-760290 3 4 5 CE-126187

Description Selector button (grey) for Encoder Cap for Selector Encoder for Selector with nut and washer Cable to Selector

Pos Order Number Description 1 EB-720740 DCU board C+, multi language 2 DI-502921 PC board locker pin

TM, elisa, CM-922280, rev. 3.03.a

8-7

8 Illustrated parts

PC board A

Note

8-8

Pos Order Number Description 1 BE-121052 PC board A, C+, in transport frame with neutral serial number for one time serialization without EPROM without PC board DCU without PC board inverter without alarm speaker A.

To protect flex connectors keep PC board A in transport frame until use.

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

PC board A LI battery

PC board Inverter

Pos Order Number Description 1 ES-759159 3 V Lithium - battery 2 EY-799130 Tie wrap for lithium battery

Pos Order Number Description 1 EB-720735 PC board, inverter, back light supply 2 BE-120091 Cable to inverter PC board 3 DI-502702 Locker pin, 2 required

TM, elisa, CM-922280, rev. 3.03.a

8-9

8 Illustrated parts

8-10

Display

Pos 1 2 3

Order Number EB-720734 DB-452322 DI-502810

Description TFT display, 12”, with back light Screw, M3 x 8, 4 required Spacer, 3.6, 4 required

Alarm speaker A

Pos 1 2 3

Order Number ES-754809 DI-501702 DC-482804

Description Alarm speaker C+ Locker pin, 2 required Washer , plastic, 3,2 mm, 2 required

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Control panel connecting cable

Back cover

Pos Order Number Description 1 MA-120019 Control panel connecting cable kit

Pos Order Number Description 1 MA-352401 Back cover for control panel

TM, elisa, CM-922280, rev. 3.03.a

8-11

8 Illustrated parts

8.5 Expiration valve spare parts Expiration valve assembly - Standard

Pos Order Number Description 1 BM-352399 Standard expiration valve assembly, (silver) complete

Pos Order Number Description 2 BM-352398 PEEP membrane assembly, complete 2a) CM-525531 PEEP TOP seal membrane 2b) CM-510130 PEEP PSU plate 2c) CM-510129 PEEP Silicone membrane 3 CM-510111 Stainless steel plate for PEEP membrane 4 DO-628232 O-ring 30 x 2 5 DO-628204 O-ring 6 x 1.5, for flow measurement port 6 CM-523034 Flow screen, Standard 7 CM-510133 Retainer for flow screen MA-640012 PEEP valve PM kit, consisting of Pos. 2, 4, 5

8-12

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Expiration valve assembly - Newborn

Pos Order Number Description 1 BM-352400 Newborn expiration valve assembly, (blue) complete

Pos Order Number Description 2 BM-352398 PEEP membrane assembly, complete 2a) CM-525531 PEEP TOP seal membrane 2b) CM-510130 PEEP PSU plate 2c) CM-510129 PEEP Silicone membrane 3 CM-510111 Stainless steel plate for PEEP membrane 4 DO-628232 O-ring 30 x 2 5 DO-628204 O-ring 6 x 1.5, for flow measurement port 6 CM-523035 Flow screen, Newborn 7 CM-510133 Retainer for flow screen MA-640012 PEEP valve PM kit, consisting of Pos. 2, 4, 5

TM, elisa, CM-922280, rev. 3.03.a

8-13

8 Illustrated parts

8.6 Main engine spare parts Expiratory valve control assembly

Locking spring

8-14

Pos Order Number Description 1 BM-352411 Expiration valve control assembly (without expiration valve assembly) 2 DB-452322 Screw M3 x 8, 2 required 3 DH-473704 Washer, 3.2, 2 required 4 DA-444201 Screw M3 x 6, 1 required 5 CE-126092 Cable to B board

Pos Order Number Description 1 CM-510123 Locking spring in expiration valve assembly

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Patient connection assembly

O2 sensor

Patient tube

Pos Order Number Description 1 BM-352210 Patient connection assembly, without O2 sensor, without patient tube 2 CM-510137 Front cone

Pos Order Number Description 1 EB-758196 O2 sensor 2 CE-126096 Cable to O2 sensor

Pos Order Number Description 1 CS-615042 Patient tube, 22mm x 250 mm

TM, elisa, CM-922280, rev. 3.03.a

8-15

8 Illustrated parts

Back-up battery assembly

Transformer

8-16

Pos Order Number Description 1 MA-630020 Battery pack, 24 V 2 DE-490460 Nut, M4 with washer, 2 required

Pos 1 2 3

Order Number BE-120088 EX-744350 DE-490460

Description Transformer Connector, line power (not shown) Nut, M4 with washer, 3 required

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

PC board B assembly

Pos Order Number Description 1 BE-120120 PC Board B, without B EPROM 2 EF-761080 Fuse 0.5 A slow blow, 5 x 20 mm (not shown) 3 EF-761079 Fuse 0.8 A slow blow, 5 x 20 mm (not shown) 4 EF-761083 Fuse 1.0 A slow blow, 5 x 20 mm (not shown) 5 EF-761090 Fuse 3.15 A slow blow, 5 x 20 mm (not shown) 6 DG-463004 Nut, M3, 3 required 7 DI-502810 Spacer, 3.6, 3 required

TM, elisa, CM-922280, rev. 3.03.a

8-17

8 Illustrated parts

Pneumatic assembly

Pos Order Number Description 1 BM-352409 Pneumatic assembly, complete 2 DG-460460 Screw M4 x 35

Free breathing valve

Pos Order Number Description 1 DO-626000 Free breathing valve

8-18

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Gas connectors

Pos. Order Number 1 CM-530043 2 CM-530044 3 CM-530045 4 CM-530046 5 CM-530047 6 CM-530048 7 CM-530049 8 CM-530050 9 CM-530051 10 CM-530052 11 CM-530053 12 CM-530054 13 DO-628208

Description

Pos. Order Number 1 CM-525764 2 DO-628203

Description

NIST connector AIR NIST connector O2 DISS connector AIR DISS connector O2 BSBP G ¼ connector AIR BSBP G ¼ connector O2 BSBP G 3/8 connector AIR BSBP G 3/8 connector O2 S90/116 connector AIR S90/116 connector O2 DISS FEMALE connector AIR DISS FEMALE connector O2 O-ring 8,3 x 2,4, fits all connectors

Gas connector filters

TM, elisa, CM-922280, rev. 3.03.a

Sinter filter universal O-ring 5x1 to sinter filter

8-19

8 Illustrated parts

Fan assembly

Alarm speaker B

8-20

Pos 1 2 3

Order Number EM-777213 DA-444224 DG-463013

Description Fan, complete Screw, M4 x 12, 4 required Nut, M4 self secure, 4 required

Pos Order Number Description 1 BE-120101 Alarm system for PC board B, complete 2 DB-452322 Screw, M3 x 8, 2 required 3 DH-473704 Washer, 3.2, 8 required 4 DG-463004 Nut, M3, 2 required

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Line connector assembly

ON / OFF switch assembly

Pos Order Number Description 1 BE-133434 Line connector assembly, complete 2 EF-761079 Fuse 0.8 A slow blow, 5 x 20 mm, (for 230 V line voltage) (not shown, 2 required) 3 EF-761085 Fuse 1.6 A slow blow, 5 x 20 mm, (for 115 V line voltage) (not shown, 2 required)

Pos Order Number Description 1 BE-120114 ON / OFF switch assembly, complete 2 ES-754476 Green cap 3 ES-754477 White inlay 4 EU-748295 LED light, green, 24 V

1)

TM, elisa, CM-922280, rev. 3.03.a

4)

3)

2)

8-21

8 Illustrated parts

On/Off switch interface PC board kit

Pos Order Number Description 1 ME-510207 On/Off switch interface PC board kit with 1) On/Off switch interface PC board including fixed cables 2) Washer 3) Hex Standoff 4) Nylok Nut

1)

8-22

2)

3)

4)

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

DC main connector assembly

Ground stud assembly

Pos Order Number Description 1 BE-120095 DC Main connector assembly, complete

Pos 1 2 3 4 5

Order Number EY-750840 EY-750842 CM-919026 DG-463008 BE-120112

6 7

DH-473763 DH-473707

4)

TM, elisa, CM-922280, rev. 3.03.a

6)

Description Ground stud Color code plate Label (not shown) Nut M6 Cable to common ground (not shown, 1 required) Washer, contact M6/8 2-A4 Washer, spring A 6.5 (not shown, 1 required)

2)

1)

8-23

8 Illustrated parts

Serial data connector assembly

Sub chassis

Tubing kit

Upper housing

8-24

Pos Order Number Description 1 BE-120094 Serial data connection assembly, complete with nuts and bolts

Pos Order Number Description 1 DE-490460 Nut M4 with washer (not shown, 4 required)

Pos Order Number Description 1 MA-640002 Tubing kit, consisting of - tube set A - tube set B - tube set C - tube set D Pos Order Number Description 1 BM-352410 Upper housing

TM, elisa, CM-922280, rev. 3.03.a

8 Illustrated parts

Lower housing

Pos Order Number Description 1 CM-510194 Lower housing without assemblies 2 BM-352211 Housing feet (not shown, 4 required) 3 DG-460336 Screw, M4 x 70 mm (not shown, 1 required) 4 DG-460337 Screw, M4 x 110 mm (not shown, 2 required) 5 CX-526323 Locker pole (not shown, 1 required)

Labels

Pos 1 2 3

Order Number CM-919029 MA-640003 MA-640005

Description Serial number plate, without s/n Labeling kit, 115V Labeling kit, 230 V

Nebulizer parts

Pos 1 2 3

Order Number CM-522200 DE-490708 CS-615052

Description Nebulizer connection Nut to nebulizer connection M8 PVC tube nebulizer, 4x1, 200 mm

TM, elisa, CM-922280, rev. 3.03.a

8-25

8 Illustrated parts

Hardware kit

Pos Order Number Description 1 MA-640006 Hardware kit elisa, consists of - different nuts - different bolds - different washers - different spacers - etc. to build a elisa

Service tools

Pos 1 2 3

Line plug locking spring

8-26

Order Number AZ-381501 MA-640007 BE-126081

Description Test lung kit, ST3 Tool kit. ST4 Service cable

Pos Order Number Description 1 EY-750691 Line plug locking spring

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

In this section

9.1 Pneumatic diagram 9.2 Electrical diagram 9.3 Component layout, PC board B 9.4 Component layout, PC board A 9.5 Tubes and connectors 9.6 Cable Routing 9.6.1 Cable routing for PC board B 9.6.2 Cable harness fixing routing 9.6.3 Pneumatic hose routing 9.7 List of fuses 9.8 Screw connectors 9.9 Accepted ranges 9.10 Sensor data ranges 9.11 DIP switch settings 9.12 Serial data transfer

TM, elisa, CM-922280, rev. 3.03.a

9-2 9-4 9-6 9-7 9-8 9-11 9-11 9-14 9-14 9-15 9-16 9-17 9-18 9-18 9-19

9-1

9-2

270 - 620 kPa

Air input

P 11

O2 input 270 - 620 kPa

P 01

P 32

AIR supply monitor

P 12

P 31

O2 supply monitor

P 02

270 kPa

270 kPa

P 14

Prop. Valves AIR

P 13

P 04

Prop. Valves O2

P 03

P 35

Nebulizer valves

Offset valve

Offset valve

EB M01

Diaphragma AIR

P 16

P 15

EB M06

P 22

Internal tubing

P 07

Sensor O2 flow

Nebulizer connector

P 36

Sensor AIR flow

Diaphragma O2

P 06

P 05

P 33

P 21

Overpress. Valve105 mbar

Underpress. Valve

P 19

O2 Sensor

Insp. Flow connector

P 23

. Valve Electrical Overpress

P 20

EB S20

Offset valve

EB M11

Sensor Pressure

Exp. Flow grid

P 29

EB E01

Sensor Exp. flow

Offset valve

Exp. Valve

P 27

P 28

Pneumatic overview Revision 3.04.X A.Schober 11.05.09

Elisa

Exp. Flow connector

P 26

P 24

Patient flow humidifier

P 25

9 Schematics and Diagrams

9.1 Pneumatic diagram

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

Legend to pneumatic diagram Identifier P01 P02 P03 P04 P05 P06 P07 P11 P12 P13 P14 P15 P16 P19 P20 P21 P22 P23 P24 P25 P26 P27 P28 P29 P31 P32 P33 P34 P35 P36 EB M01 EB M06 EB M11 EB E01 EB S20 P 08, P 09, P 10, P17, P 18, P 30

Description O2 input O2 supply pressure sensor Proportional solenoid, O2, flow # 1 Proportional solenoid, O2, flow # 2 Offset solenoid O2 flow Flow screen O2 flow Internal hoses AIR input AIR supply pressure sensor Proportional solenoid, AIR, flow # 1 Proportional solenoid, AIR, flow # 2 Offset solenoid, AIR flow Flow screen, AIR flow Spontaneous breathing valve (free breathing valve) Overpressure relief vale (passive) Pressure limiting solenoid (active) Offset solenoid airway pressure Inspiratory connector (patient connection) Breathing circuit Y-piece Expiratory connector (exp. valve) Expiratory (PEEP) valve Offset solenoid expiratory flow Flow screen, expiratory flow Pressure reducer O2 Pressure reducer AIR Nebulizer gas selection solenoid Nebulizer O2 solenoid Nebulizer AIR solenoid Nebulizer connection AIR flow sensor O2 flow sensor Airway pressure sensor Expiratory flow sensor O2 sensor Not applicable Not applicable

TM, elisa, CM-922280, rev. 3.03.a

9-3

9 Schematics and Diagrams

9.2 Electrical diagram

9-4

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

elisa Electrical overview Revision 3.x A.Schober 27.12.05 Salvia Lifetec

TM, elisa, CM-922280, rev. 3.03.a

9-5

9 Schematics and Diagrams

9.3 Component layout, PC board B

9-6

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

9.4 Component layout, PC board A

TM, elisa, CM-922280, rev. 3.03.a

9-7

9 Schematics and Diagrams

9.5 Tubes and connectors Main board B with offset valves “Fluid automation”

9-8

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

Connectors on PC board A (control panel) Identifier Where located

To connect

X1 ST1, ST4 X3 X5 X 12 X 14 X30

Alarm speaker, control panel DCU board Back light inverter Selector TFT screen SIO, to main engine Touch screen

Control Panel PC board A Control Panel PC board A Control Panel PC board A Control Panel PC board A Control Panel PC board A Control Panel PC board A Control Panel PC board A

No. of pins 2 16 8 6 24 4 5

Connectors on PC board B (main engine)

Identifier X10 X12 X14 X15 X16 X21

Where located Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B

X22 X23 X24 X31 X41 X42 X43 X44

Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B Main engine PC board B

TM, elisa, CM-922280, rev. 3.03.a

To connect Serial com port N/A SIO, to control panel Fan Alarm speaker, main engine Mains, line supply, transformer Mains, external DC supply Internal battery On- Off switch O2 sensor N/A PEEP valve assembly N/A Pneumatic assembly

No. of pins 5 4 4 3 2 3 3 2 4 3 8 10 2 16

9-9

9 Schematics and Diagrams

Tubes Identifier From

To

Type

Within PC board B A Transducer A B Transducer B C Transducer C D Transducer D

Offset valve A Offset valve B Offset valve C Offset valve D

Silicon, 5 mm φ Silicon, 5 mm φ Silicon, 5 mm φ Silicon, 5 mm φ

From PEEP valve control assembly to PC board B A Expiratory flow port Offset valve A From inspiratory connection assembly to PC board B B Patient (Airway) Offset valve B pressure port From pneumatic assembly to PC board B C AIR flow, upper port Offset valve C C’ AIR flow, lower port Transducer C – T piece -Offset valve C D O2 flow, upper port Offset valve D D’ O2 flow, lower port Transducer D – T piece -Offset valve D n/a Ambient port T-piece - transducer A, T-piece - transducer B, T-piece - offset valve A, T-piece - offset valve B

Silicon, 5 mm φ

Silicon, 5 mm φ

Silicon, 5 mm φ Silicon, 5 mm φ, T piece Silicon, 5 mm φ Silicon, 5 mm φ, T piece Silicon, 5 mm φ, T piece

From inspiratory connection assembly to pneumatic assembly n/a Inspiratory port Exit of pneumatic “white” patient tube, 22 assembly mm φ

9-10

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

9.6 Cable routing 9.6.1 Cable routing PC board B

The following picture shows the correct order of the cable routing in PC board B.

1.

2.

3.

4.

TM, elisa, CM-922280, rev. 3.03.a

9-11

9 Schematics and Diagrams

5.

6.

7.

8.

9-12

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

9.

10.

11.

TM, elisa, CM-922280, rev. 3.03.a

9-13

9 Schematics and Diagrams

9.6.2 Cable harness fixing routing

The following pictures show the correct order for the fixation of the cable harness.

1.

2.

9.6.3 Pneumatic hose routing

9-14

The following picture shows the routing of the pneumatic hoses

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

9.7 List of fuses 230 V line voltage Identifier Where located SI 0 a Line inlet connector SI 0 b Line inlet connector

To secure Line supply Line supply

Type 5 x 20 mm 5 x 20 mm

Value 0.8 A slow blow 0.8 A slow blow

To secure Line supply Line supply

Type 5 x 20 mm 5 x 20 mm

Value 1.6 A slow blow 1.6 A slow blow

115 V line voltage Identifie Where located SI 0 a Line inlet connector SI 0 b Line inlet connector

Internal fuses Identifier SI 1 SI 2 SI 300 SI 380 SI 381 SI 10 SI 11 SI 21 SI 22 SI 23 SI 24 SI 25 SI 26 SI 27 SI 28 SI 41

Where located Control Panel PC board A Control Panel PC board A Control Panel PC board A Control Panel PC board A

To secure Battery supply Buzzer supply LCD back light Control panel supply Control Panel PC board A 5 V controller supply Main engine PC board B Buzzer supply Main engine PC board B Fan Main engine PC board B Transformer sec. 1 Main engine PC board B Transformer sec. 2 Main engine PC board B Line DC inlet Main engine PC board B Back-up battery Main engine PC board B Battery charger Main engine PC board B + 13 V bus Main engine PC board B + 15 V bus Main engine PC board B + 5 V bus Main engine PC board B Exp. Valve heater

TM, elisa, CM-922280, rev. 3.03.a

Type 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm

Value 0.032 A fast blow 0.315 A slow blow 0.8 A slow blow 0.8 A slow blow

5 x 20 mm

1.6 A slow blow

5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm 5 x 20 mm

0.315 A slow blow 0.5 A slow blow 3.15 A slow blow 3.15 A slow blow 3.15 A slow blow 3.15 A slow blow 0.5 A slow blow 3.15 A slow blow 3.15 A slow blow 0.5 A slow blow 1.0 A slow blow

9-15

9 Schematics and Diagrams

9.8 Screw Connectors Line connector 230 V

115 V

Transformer connector

X 21

1

grey

2

orange

3

grey

4

orange

5

red

6

blue

External DC connector

X 22

Internal battery connector X 23

9-16

7

red

8

blue

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

9.8 Accepted ranges Mains line supply AC line voltage 115 V AC line voltage 230 V DC mains voltage Power consumption Breathing circuit Total compliance Insp. resistance Total resistance Resistance test flow Total leakage Nebulizer supply pressure Nebulizer flow range Nebulizer gas source Service menu Line voltage AC Line voltage DC Panel voltage Valve voltage (Back up) Battery voltage Controller A voltage Controller B voltage Heater power Exp. temperature Insp. temperature Gas supply AIR supply pressure O2 supply pressure AIR pressure reducer setting O2 pressure reducer setting AIR supply pressure low signal O2 supply pressure low signal AIR supply flow O2 supply flow AIR supply flow low signal O2 supply flow low signal AIR 2nd stage flow valve turn on O2 2nd stage flow valve turn on

Accepted range 98.0 to 132 V AC, 50 to 60 Hz 198 to 263 V AC, 50 to 60 Hz 22.5 to 28.0 V DC < 50 W Accepted range 0.5 to 5.0 mL/cmH2O < 6.0 cmH2O/L/s (SW rev. 2.21 +) < 15 cmH2O /L/s (SW rev. 2.21 +) 60L/min in Adult mode, 30 L/min in Pediatric mode < 1,000 mL/min 16 to 20 kPa, 22.5 to 28.2 PSI (at given flow range) 4.0 to 12.0 L/min AIR at FiO2 < 60%, O2 at FiO2 >= 60 % Accepted range 19.0 to 29.0 V DC 22.5 to 28.0 V DC 12.5 to 17.0 V 11.5 to 15.0 V 22.5 – 29.0 V DC 4.50 to 5.50 V DC 4.50 to 5.50 V DC 0.0 to 12.0 W 5.0 to 48.0 °C 5.0 to 48.0 °C Accepted range 270 to 620 kPa, 40 to 90 PSI 270 to 620 kPa, 40 to 90 PSI 2.7 kPa, 38.0 to 39.0 PSI 2.7 kPa, 38.0 to 39.0 PSI 1.6 to 2.2 kPa, 23 to 31 PSI 1.6 to 2.2 kPa, 23 to 31 PSI Minimum 110 L/min Minimum 110 L/min 106 to 108 L/min 106 to 108 L/min 42 to 45 L/min 42 to 45 L/min

TM, elisa, CM-922280, rev. 3.03.a

9-17

9 Schematics and Diagrams

9.9 Sensor data ranges The following data ranges deal with the four pressure sensors, used to measure • Pat. pressure = Airway pressure • Exp. flow = Expiration flow, measured via differential pressure • AIR flow = Inspiration flow AIR, measured via differential pressure • O2 flow = Inspiration flow O2, measured via differential pressure The sensor offset values are defined in different accepted ranges • No readjust range = Offset value is within an area where re-adjustment is not necessary. • Max. auto correct range = Offset values are automatically corrected by the software during auto zeroing For sensor offset values that are outside the “No readjust” offset readjustment is necessary. According to the sensor’s warm-up drift always allow the elisa to warm up for at least 15 minutes, before taking data or performing any calibration. Rated values vary with software revisions. Type of sensor Pat. pressure Exp. flow AIR flow O2 flow

Rated No readjustment necessary (Center) range 0.00 cmH2O - 0.8 to + 0.8 cmH2O

Max. automatic correction range - 3.0 to + 3.0 cmH2O

500 digits 250 digits 250 digits

25 to 975 digits 25 to 475 digits 25 to 475 digits

375 to 625 digits 175 to 325 digits 175 to 325 digits

9.10 DIP Switch settings PC Board A does not carry any DIP switches. PC board B (P/N BE-120120) is equipped with a DIP switch for factory setting and testing. No setting is required in service. Leave DIP switch setting as made during factory setting. If factory setting is in doubt set all DIP switch (1 – 8) to OFF.

9-18

TM, elisa, CM-922280, rev. 3.03.a

9 Schematics and Diagrams

9.11 Serial data transfer elisa provides capabilities to transfer ventilation parameter, pressure - and flow waveform, all measured values and alarms to an external data management system via a serial data protocol. elisa provides three protocols on demand to a data management system: - Ohmeda Com 1.0 - Ohmeda Com 1.3 Without any request from an external data management on the serial port, elisa disables the serial data transfer. With a request from an external data management on the serial port, elisa activates the Ohmeda Com 1.0 protocol as the default. On request from an external data management on the serial port elisa activates either the Ohmeda Com 1.3 or the protocol. Connection

Protocol Ohmeda Com 1.0 and Com 1.3

Connect a RS 232 data cable at the rear side of elisa at the serial data connection (D-Sub 9 female) with the following Pin constellation: - Pin 2 receive data - Pin 3 transmit data - Pin 5 signal ground Correct connection is provided with serial cable P/N BE-120116. elisa uses the Ohmeda Com 1.0 and Com 1.3 serial protocols as default. This allows connecting elisa to all data management systems using this protocol. When connecting to an elisa system use the DIS 7900 Non-Aestiva connection box. This box provides the correct D-Sub 9 connector to connect to the elisa. Do not use the DIS 7900 AESTIVA with a DSub 15. Proper communication with the DEIO Clinisoft data management system is tested. For more details refer to information provided by the data management distributor.

TM, elisa, CM-922280, rev. 3.03.a

9-19

9 Schematics and Diagrams

Transferred Information

Waveforms Paw Flow

real Time real time

Numerical Data Ventilation mode -

Ventilator settings Vt Rate I-Flow I:E Plimit

-

Alarm Settings MV min O2-I max O2-I min

-

Measured Data Vt E MV E O2 – I Rate Ppeak Pplat Pmin Vt-I

-

Alarms O2 Max O2 Min Apnea MV E min Pressure high Pressure low Pressure sustained Sub atmospheric pressure AC line supply fail Low battery O2 limit set error Vent setting range error

9-20

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

In this section

10.1 elisa configuration mode 10.1.1 Access to configuration mode 10.1.2 Configuration modality 10.1.3 Exit configuration mode 10.1.4 Configuration parameters 10.2 Optionalization mode 10.2.1 Access to optionalization mode 10.2.2 Optionalization modality 10.2.3 Exit optionalization mode

TM, elisa, CM-922280, rev. 3.03.a

10-2 10-3 10-5 10-6 10-7 10-9 10-10 10-11 10-13

10-1

10 Configuration and optionalization

10.1 elisa configuration mode elisa allows user specific configuration of the default machine settings according to hospital’s needs for the following parameters: 1. 2. 3. 4. 5. 6. 7. 8. 9.

Language Date format Units of pressure Units CO2 (not applicable) Unit of ideal body weight Patient type Cross over weight Start ventilation mode VC Type

For safety reasons (and with respect to ergonomic and user interface safety theory) all elisa within one particular application or operation area (e.g. within one CC station) should be set to the identical configuration, so that all machines within one operation area behave identical in terms of user surface and default start. Note

10-2

This configuration is not accessible to the user to avoid misssettings of default configuration settings. It is only accessible for authorized service personnel.

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

10.1.1 Access to configuration mode

For safety reasons the elisa configuration mode is not accessible during regular operation mode. The configuration mode is only accessible during and at the end of the power-up test or the system test via the service mode. To access the configuration screen, first go into the service screen: For legal reasons the service mode is not accessible on a user level. Only trained service technicians should have access to the service mode. To enter the service mode, push the following sequence of buttons within a time frame of 1 second: 1. ”Adult” left side 2. “Adult” right side 3. “Selector”.

1

TM, elisa, CM-922280, rev. 3.03.a

2

3

10-3

10 Configuration and optionalization

Now, to enter the configuration mode push, the following sequence of buttons within a time frame of 1 second: 1. ”x 10” 2. “OPEN” 3. “Selector”.

Configuration mode now is activated and the system prompts with the following screen:

10-4

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

10.1.2 Configuration modality

All configurations operate on the same principle: 1. Rotating the Selector moves a frame to any parameter on the screen. 2. The selected parameter’s last value is framed. E.g. selected parameter “Patient type”, last value “Adult”.

3. Confirm your selection by pushing the Selector.

4. The frame inverts colors to identify that the parameter can be changed now.

5. Rotate the Selector to select from different settings. 6. A new setting for this parameter is selected. E.g. selected parameter “Patient type”, new value “Pediatric”. 7. Confirm selection by pushing the Selector.

TM, elisa, CM-922280, rev. 3.03.a

10-5

10 Configuration and optionalization

8. Confirmed change is displayed. E.g. selected parameter “Patient type”, confirmed new value “Pediatric”.

10.1.3 Exit configuration mode

After having made all desired changes to default settings exit the configuration mode with pushing the “Save” button to save all made changes to the system.

The system immediately returns to the power up test screen allowing normal operation. Pushing the “Abort” button makes the system load the previous settings, delete all made changes and return immediately to the power up test screen.

10-6

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

10.1.4 Configuration parameters

elisa allows user specific configuration of the default machine settings according to hospital’s needs for the following parameters: 1. Language User language for screen information, messages and alarms with the following selections: a. English b. German c. French d. Dutch e. Spanish f. Polish g. Portuguese h. Italian i. Türkisch 2. Date format Date and time format in trend and event views with the following selections: a. MM-DD hh:mm (ISO time and date format) b. MM/DD hh:mm (US time and date format) 3. Unit of Meas. Unit of pressure for all pressure related information and parameter with the following selections: a. cmH2O b. hPa c. cmH2O 4. Unit CO2 5. Unit IBW Unit of ideal body weight with the following selections: a. kg b. lbs 6. Patient type Default type of patient upon start up with the following selections: a. Adult b. Pediatric c. Newborn (if newborn option is activated)

TM, elisa, CM-922280, rev. 3.03.a

10-7

10 Configuration and optionalization

7. Cross over weight Weight to determine between patient Adult or Pediatric with the following selections: a. kg b. lbs 8. Start ventilation mode Default ventilation mode upon start up in patient type selection Adult/Pediatric with the following selections: a. VCV b. SIMV-VC c. Dyn-BiLevel (if Dyn-BiLevel option is activated) d. BiLevel e. CPAP 9. VC Type Default upper pressure limit performance in volume with the following selections: controlled ventilation modes: a. PLV b. PC Note

For safety reasons default ventilation mode upon start up in patient type Newborn is always BiLevel.

10.2 elisa optionalization mode elisa allows for optionalization several already on board available software options by activating a particular option code. This optionalization is only possible for one particular serial number and for one particular software version and for the desired options. The option key consists of information about 1. serial number of the device to optionalize 2. software version this option is valid for 3. options desired Software options come with a serialized 10 digit option key. This option key is printed on a small sticker. Place this sticker after optionalization onto the rear side of the Control Panel of the elisa, so that in case it needs to be re-optionalized, the option key is available at the machine.

10-8

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

Note

When ordering an option note the elisa serial number, displayed in the optionalization mode and in the service screen.

Note

If several options have to be optionalized on one machine only one option key is necessary and one optionalization clears all desired options at once,

Note

This optionalization mode configuration is not accessible to the user. It is accessible for authorized service personal only. With the current software release 3.04.p the following options can be cleared for operation: 1. Newborn This option allows to ventilate patients with a body weight from 2 to 6 kg. This option requires a dedicated (blue) newborn expiration valve assembly that comes with the option. 2. Dyn-BiLevel This option is a lung protective, automatic compliance compensating pressure controlled ventilation mode with a volume guarantee. 3. Trend and event This option allows to store, to display and to download all measured data, ventilator settings, alarm settings over a period of 30 days and up to 5000 events (e.g. alarms system messages etc). 4. Spirometry This option allows to display lung mechanics information, such as P/V and F/V loops.

TM, elisa, CM-922280, rev. 3.03.a

10-9

10 Configuration and optionalization

10.2.1 Access to optionalization mode

10-10

The access to the optionalization mode is identical with the access to the configuration mode. For details refer to section 10.1.1. Now the option menu is available and the system prompts with the following screen

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

10.2.2 Optionalization modality

To optionalize a received option key follow this sequence: 1. Rotate the Selector to select the option key by moving a frame. 2. The option key’s last value is framed.

3. Confirm made selection by pushing the Selector.

4. The last digit of the option key no is framed. E.g. “9”. 5. Confirm made selection by pushing the Selector.

6. The frame inverts colors.

7. Rotate the Selector to select the according number for this digit. 8. A new setting for the selected digit of the option key is made. E.g. “1”. 9. Confirm made selection by pushing the Selector.

TM, elisa, CM-922280, rev. 3.03.a

10-11

10 Configuration and optionalization

10. New setting for the selected digit is made. 11. Rotate the Selector to select the next digit to change. 12. The next digit of the option key no is framed. E.g. “8”. 13. Repeat steps 4. to 11. until all digits are changed according to the given option key. Note

Do not push the Selector twice to jump between digits. That will activate the main frame and deletes all changes made so fare. 14. When done with all digits push Selector again to return to the main frame.

15. The main frame surrounds the option key and at the same time the released option is displayed in the upper (+) area for options.

10-12

TM, elisa, CM-922280, rev. 3.03.a

10 Configuration and optionalization

10.2.3 Exit optionalization mode

After having released the desired options exit the optionalization mode as you exit the configuration mode with pushing the “Save” button to save all made changes to the system.

The system immediately returns to the power up test screen allowing normal operation. Pushing the “Abort” button makes the system load the previous settings, delete all made changes and return immediately to the power up test screen.

TM, elisa, CM-922280, rev. 3.03.a

10-13

10 Configuration and optionalization

Notes

10-14

TM, elisa, CM-922280, rev. 3.03.a

11 Optional accessories

In this section

11.1 External battery pack 11.1.1 Replace battery 11.1.2 Replace battery pack connector cable 11.1.3 Replace fuse 0.8 A 11.1.4 Replace fuse 3.15 A 11.1.5 Spare parts for external battery pack 11.2 Cart 11.3 Compressor 11.4 Support arm

TM, elisa, CM-922280, rev. 3.03.a

11-2 11-2 11-3 11-4 11-4 11-5 11-8 11-9 11-10

11-1

11 Optional accessories

11.1 External battery pack 11.1.1 Replace battery

The elisa external battery pack needs replacement of the batteries every 24 months. To replace the batteries follow this sequence:

1. Disconnect the external battery pack from elisa and lift the elisa from the external battery pack. 2. Disconnect the external battery pack from the charger, if connected. 3. Open the external battery pack by remove the screws on top of the aluminum plate. 4. Disconnect batteries from the relays and the connectors inside. 5. Remove the batteries from the housing. 6. Insert the new batteries. 7. Connect batteries to each other, to the relay and connector as seen in the wiring diagram

Note

Connect the connector cables in a correct way.

8. Close the external battery pack 9. Connect the charger to the charging port of the external battery pack. 10. Allow the battery pack to be charged at least 12 hours and verify proper charging.

Note

11-2

Always replace both batteries at the same time.

TM, elisa, CM-922280, rev. 3.03.a

11 Optional accessories

11.1.2 Replace battery pack connector cable

Note Note

To replace the connector cable from the external battery pack, follow this sequence: 1. Disconnect the external battery pack from elisa according to section 11.1.1. 2. Open the external battery pack by removing the screws on top of the aluminum plate according to section 11.1.1. 3. Disconnect the connector cables inside by lifting the plugs from the sockets. 4. Remove the battery pack connector cable using a 15 mm flat spanner to unscrew the cable from the housing. 5. Insert the new battery pack connector cable through the case and reconnect the connector cable inside. Connect the large connector to the large terminal and small connector to small terminal - reference pictures below. 6. Tighten the connector cable to the external battery pack housing by using a 15 mm flat spanner.

The terminals on the control board are different sizes, is a one small terminal and one is a large terminal. When connecting the battery pack connector cable, connect the large connector to the large terminal and small connector to small terminal. 7. Close the external battery pack.

TM, elisa, CM-922280, rev. 3.03.a

11-3

11 Optional accessories

11.1.3 Replace fuse 0.8 A

To replace the 0.8 A fuse in the external battery pack, follow this sequence: 1. Disconnect the external battery pack from elisa according to section 11.1.1. 2. Open the external battery pack by unscrewing the screws on top of the aluminum plate according to section 11.1.1. 3. Replace the fuse. 4. Close the external battery pack. 5. Connect the battery pack to the elisa.

11.1.4 Replace fuse 3.1 A

To replace the 3.1 A fuse in the external battery pack, follow this sequence: 1. Remove the fuse holder by using a screwdriver. 2. Replace the fuse. 3. Insert the new fuse.

11-4

TM, elisa, CM-922280, rev. 3.03.a

11 Optional accessories

11.1.5 Spare parts for external battery pack External Battery Pack

Pos 1 2 3

Order Number AZ-391975 BM-352211 KE-749293

4

EY-752151

5

EY-752152

6

EY-752153

3) Battery

2)

Description Battery Pack Feet (4 pcs) Power Supply for the External Battery Pack 230/115 V, 50/60 Hz Power supply line adapter for EU ( no picture) Power supply line adapter for UK (no picture) Power supply line adapter for USA (no picture)

1)

Pos Order Number Description 1 ES-759153 Lead acid battery, one, (two needed)

TM, elisa, CM-922280, rev. 3.03.a

11-5

11 Optional accessories

Fuses

Pos Order Number Description 1 EF-761079 Fuse 0,8 A slow blow 2 EF-761090 Fuse 3,15 A slow blow

1)

Battery pack connector cable

Control board

11-6

2)

Pos Order Number Description 1 BE-120151 Battery pack connector cable

Pos Order Number Description 1 BE-121056 Control board external battery-pack

TM, elisa, CM-922280, rev. 3.03.a

11 Optional accessories

Housing

Hardware kit

Pos 1 2 3 4 5

Order Number CX-526250 CX-526251 CX-526253 CX-526254 DO-627181

Description Housing of the external battery-pack Cover plate of the external battery-pack Swivel plate Slider Foam pad (no picture)

1)

2)

3)

4)

Pos Order Number Description 1 MA-640011 Hardware kit elisa external battery pack, consists of: different nuts different pins different screws different washer different b ect. to build an elisa external battery pack.

TM, elisa, CM-922280, rev. 3.03.a

11-7

11 Optional accessories

11.2 Cart Replace castor

This replacement instruction deals with the following carts - P/N AZ-383110 - P/N AZ 383125. The elisa cart has in total four castors, two with brakes in the front and two without brakes in the rear. To replace a castor follow this sequence: 1. Remove elisa from the cart. 2. Remove an active humidifier from the cart, if applied. 3. Remove the support arm from the cart. 4. Remove any additional parts mounted to the cart. 5. Carefully lay down the cart. 6. Remove castor by loosening upper castor bold using a 10 mm wrench. 7. Remove castor. 8. Mount the new castor. Remember that front castors have brakes and rear castors don’t. 9. Tighten 10 mm bold. 10. Verify proper function of castor and brake, if applied.

Spare parts

11-8

Pos 1 2 3

Order Number CW-768443 CW-768442 DE-495467

Description Castor for cart with brake Castor for cart without brake Cart “star” button for fixation

TM, elisa, CM-922280, rev. 3.03.a

11 Optional accessories

11.3 Compressor Compressor A40

For detailed repair instruction see compressor service instruction, supplied by the manufacturer.

TM, elisa, CM-922280, rev. 3.03.a

11-9

11 Optional accessories

11.4 Support arm Replace tube holder

Replacement of the tube holder does not require any tools. To replace a tube holder follow this sequence: 1. Loosen the handle crimping the ball joint of the tube holder. 2. Remove the tube holder out of the ball joint. 3. Replace tube holder. 4. Fix ball joint with handle.

Spare parts

11-10

Pos Order Number Description 1 AZ-389127 elisa support arm 2 AZ-389130 Tube holder for support arm for breathing system with 2 x 22 mm with ball joint 3 AZ-389131 Tube holder for support arm for breathing system with 2 x 22 mm 4 AZ-389132 Tube holder for support arm for breathing system with 1 x 22 mm

TM, elisa, CM-922280, rev. 3.03.a

A1 Appendix

In this section

A 1.1 Service Log Downloader A1-2

TM, elisa, CM-922280, rev. 3.03.a

A1-1

A1 Appendix 1

Service log downloader The “Service log downloader” is a software download tool that is intended to download the service log of elisa onto a PC or Laptop. This downloaded service log file can be either analyzed by separate Parser programs or emailed to service help desk for further analysis.

WARNING

Computer requirements:

Although the front side Lemosa port of the elisa is galvanically isolated and allows connecting PC or laptop, always perform a service log download when no patient is connected and device is not in operation mode. Operating system: • Microsoft Windows 2000 or • Microsoft Windows XP Professional or • Microsoft Windows XP Home Edition Hardware: • RS-232 serial port • USB port, when using a standard Serial-To-USB converter • If your computer does not have an RS-232 port it is possible to source locally a USB to RS-232 converter to allow this connection

Installing and uninstalling the software

The "elisa Service Log Downloader" is a stand alone executable (elisa.exe) and does not require installation. Simply copy it to the desired location on your hard disk. To uninstall delete the program file elisaLog.exe Double click on the icon to start the service log downloader.

Using of the elisa service log downloader

The screen will show the service log downloader as follows:

1.

A1-2

Use the „Com Port“ drop down to select the computer’s communication port that is connected with the service cable to the elisa. In this example COM 3 is selected. TM, elisa, CM-922280, rev. 3.03.a

A1 Appendix

2.

Prior to downloading you need to tell the service log downloader where to store the service log to download. Open „Select file“, to select the folder where to store the service log.

Give the file a name that identifies: Name of device Serial number Date and time of download Now the screen looks like this:

Notice the “Start” button is now activated. 3.

Press the “Start” button to start the download.

During the process a progress bar and text prompts will provide feedback.

TM, elisa, CM-922280, rev. 3.03.a

A1-3

A1 Appendix 1

Please note that the complete download process may take up to 5 minutes. When the download completes successfully the prompt “FINISHED” is displayed. The service log has been downloaded and stored in the file selected in step 2.

Failure message

When the connection is not properly working the service log downloader will prompt with the message “ERROR”.

In this case check: the com port of the PC/laptop to be the correct one the connection of the service cable to the PC the connection between service cable and USB–RS 232 converter, if applicable the connection of the service cable to the elisa

A1-4

TM, elisa, CM-922280, rev. 3.03.a

A1 Appendix

Close the service log downloader

What to do with the service log file?

Manufacturer and owner of the copyright is

After downloading close the program with the windows X on the right top corner.

For further analysis use special excel templates, provided by Heinen + Löwenstein or Salvia Lifetec.

Salvia Lifetec Geräte für Medizintechnik GmbH & CO KG Niederhöchstädterstr. 62 61476 Kronberg Germany Fon: +49 617393330 Fax: +49 6173933329

Notes

TM, elisa, CM-922280, rev. 3.03.a

A1-5