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G30/G40 Patient Monitors Service Guide

May 2009

English Part Number 13304001000

1

Product Information Product models: G30/G40 Product name: Patient Monitor

Standard The product is made under the ISO9001 and ISO13485 quality system certified by TUVPS. The product has passed the CE certification.

Manufacturer Information Shenzhen Goldway Industrial Inc. Goldway Building, No. 3 Road, North Section, Shenzhen High-Tech Industrial Park, Shenzhen, P.R. China 518057 Tel: +86 755 26980999 Fax: +86 755 26980222

Version The content of this manual can change without notice due to software upgrades. ■ Edition date: May 2009

Shenzhen Goldway Industrial Inc. All Rights Reserved.

Safety Conventions The guide uses the following conventions for Notes, Cautions, and Warnings.

Note

A Note calls attention to an important point in the text.

Caution

A Caution calls attention to a condition or possible situation that could damage or destroy the product or the user’s work.

Warning

A Warning calls attention to a condition or possible situation that could cause injury to the user and/or patient.

2

Explanation of Symbols The following symbols appear on the monitor and its packaging.

Table 1 Monitor Symbols Symbol

Description CE Mark

Symbol

Description Fragile, handle with care

Recyclable

Keep upright

Recovery

Maximum stacking

Humidity

Caution

Temperature

CF applied part: Including F applied part (float/insulation) and defibrillation-proof function. BF applied part: including F applied part (float/insulation) and defibrillation-proof function. CO2 Connector

Atmospheric pressure

Keep dry SpO2 probe connector

Waveform freeze key

ECG connector

Alarm silence key

IBP1 connector

Print key

IBP2 connector

NIBP key

NIBP cuff connector

Main Menu key

TEMP1 connector TEMP2 connector

AC power LED

On/Standby button

Equipotential grounding post

Charging LED

3

Table 1 Monitor Symbols(Continued) Symbol

Description Param Menu button

Symbol

Description Dangerous Voltage

Manufacturer address

Display output

EU representatives

Serial Number

Nurse call connector

Date of manufacture

ECG analog output port

Protective grade

Consult Instructions for Use

Gas input

Caution: USA Federal Law restricts this device to sale by or on the order of a clinician. Fuse

Gas output

Ethernet port

USB port

Protective grounding

Regulatory and Safety Specifications Declaration

The G30 and G40 monitors are Class IIb devices and comply with the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and carry CE-marking accordingly.

Authorized EU Representative Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537

Hamburg, Germany

Tel: +49 40 2513175 Fax: +49 40 255726 4

Product Support and Warranty Information Warranty period for the G30/G40 monitor is one year from the date of shipment. Warranty is “parts only” and does not include any labor. Shipping of replacement parts is included in the warranty. Warranty claims for parts require the return of the defective materials to Goldway.

Accessories that are included with the product are warranted for 6 months from the date of shipment of the original product. Warranty for accessories is “replacement”.

Keep the packaging in case you need it for transport, storage, or maintenance. Goldway is responsible for the safety, reliability and performance of the monitor when the: • Product is assembled, upgraded, altered, or maintained by authorized service representatives. • Electric facilities where the monitor is placed are in conformity with the national standard. • Product is used according to this guide. Goldway is not responsible for damage to the monitor when the: • Damage is caused by: – Improper operation. – Improper connection of the monitor to other devices. – Accident. • Monitor is altered without written authorization from Goldway. • Serial number of the monitor is removed or becomes illegible.

After Sales Service Customer Service Department of Shenzhen Goldway Industrial Inc. Goldway Building, No. 3 Road, North Section, Shenzhen High-Tech Industrial Park, Shenzhen, P. R. China 518057 The international call center can be reached during the following times: Monday – Friday (Except Chinese statutory holidays) BJT 08:30~12:00, 13:30~18:00 (GMT+8) Tel: +86 755 86278308 Fax: +86 755 86278392 5

E-mail: [email protected] (English and Chinese ONLY)

Primary repair strategy：assembly/component replacement Secondary repair strategy：return for repair (to International bench repair)

When you need product support: • Contact our agent or distributor • Contact our nearest office Before calling for service, note the following information: • Model and serial number of the monitor • Monitor problem

Safety Standards Table 2 Safety Standards Parameter Specification Protection Class Class I, anti-shock, externally and internally powered equipment, per IEC 60601-1 Degree of Protection • Type CF defibrillator-proof: per IEC 60601-1 • Degree of noxious-liquid proof as IPX1 • Anti-shock degree as combination of BF and CF applied part • According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Sterilization and disinfection As recommended by manufacturer Mode of Operation

Continuous

6

Contents

Table of Contents

Chapter 1 General Introduction

1-1

1.1 About the Guide......................................................................................................1-2 1.1.1 Brief Introduction .................................................................................................1-2 1.2 Product Information................................................................................................1-2 1.2.1 General..........................................................................................................1-2 1.2.2 Main Components .........................................................................................1-2 1.2.3 Intended Use .................................................................................................1-3 1.2.4 Audience .......................................................................................................1-3 1.2.5 Networking Capabilities ...............................................................................1-3 1.3 Before You Begin ...................................................................................................1-4 1.4 Monitor and Accessories Inspection.......................................................................1-4 1.5 Cleaning..................................................................................................................1-5 1.6 Returning the Monitor For Service .........................................................................1-5 1.7 Setting up the Monitor ............................................................................................1-6 1.8 Before Powering On ...............................................................................................1-6 1.9 Setting Demo Mode ................................................................................................1-7 1.10 Setting the Networking .........................................................................................1-8

Chapter 2 Maintenance

2-1

2.1 Testing and Inspection Guidelines ..........................................................................2-3 2.2 Maintenance Plan....................................................................................................2-4 2.2.1 Visual Inspection...........................................................................................2-4 2.2.2 Cleaning ........................................................................................................2-4 2.2.3 Performance Verification ..............................................................................2-4 2.2.4 Leakage Current Test ....................................................................................2-4 2.2.5 NIBP Calibration...........................................................................................2-4 2.2.6 CO2 Gas Measurement Calibration Check....................................................2-5 2.2.7 IBP Calibration..............................................................................................2-5 2.3 Visual Inspection.....................................................................................................2-6 Contents-1

Contents

2.4 Cleaning..................................................................................................................2-6 2.4.1 General Guidelines........................................................................................2-6 2.4.2 Cleaning and Disinfecting.............................................................................2-7 2.4.3 Cleaning the Cables ......................................................................................2-7 2.4.3.1 Cleaning the Accessories ...........................................................................2-7 2.4.3.2 SpO2 Accessories .......................................................................................2-8 2.4.3.3 NIBP Cuffs.................................................................................................2-9 2.4.3.4 Temperature Accessories............................................................................2-9 2.4.3.5 Cleaning the Recorder................................................................................2-9 2.4.3.6 Disinfecting Guidelines............................................................................2-10 2.5 Performance Verification Testing..........................................................................2-11 2.5.1 Manufacturer’s Responsibility ....................................................................2-11 2.5.2 Recommended Frequency...........................................................................2-11 2.5.3 Required Test Equipment............................................................................2-12 2.5.4 Testing Record ............................................................................................2-13 2.5.5 Power Supply and Battery Test ...................................................................2-13 2.5.6 ECG Test .....................................................................................................2-14 2.5.7 Respiration Test...........................................................................................2-14 2.5.8 Temperature Test .........................................................................................2-14 2.5.9 IBP Test.......................................................................................................2-15 2.5.10 Pulse SpO2 Test .........................................................................................2-15 2.5.11 NIBP Test ..................................................................................................2-15 2.5.12 Speaker Test ..............................................................................................2-17 2.5.13 Networking Test ........................................................................................2-17 2.6 Electrical Safety Test ............................................................................................2-17

Chapter 3 Troubleshooting

3-1

3.1 Power Problems ......................................................................................................3-2 3.2 Display Problems....................................................................................................3-9 3.3 Alarm Problems ....................................................................................................3-10 3.4 NIBP Problems .....................................................................................................3-10 3.6 Temperature Problems ..........................................................................................3-11 3.7 SpO2 Problems......................................................................................................3-11 3.8 etCO2 Problems ....................................................................................................3-11 3.9 ECG/Respiration Problems...................................................................................3-12 Contents-2

Contents

3.10 Recorder Problems..............................................................................................3-13 3.11 Performance Verification Testing........................................................................3-14

Chapter 4 Theory of Operation

4-1

4.1 System Configuration .............................................................................................4-2 4.2 Theory of Operation................................................................................................4-3 4.2.1 System Overview ..........................................................................................4-3 4.2.2 Block Diagram Components .........................................................................4-3 4.2.3 ARM Module.................................................................................................4-4 4.2.4 Main Board Assembly ...................................................................................4-4 4.2.5 I/O Module Assembly ...................................................................................4-4 4.2.6 Speaker ..........................................................................................................4-5 4.2.7 Recorder ........................................................................................................4-5 4.2.8 AC/DC Power Module ..................................................................................4-5 4.2.9 Keys and Navigation Wheel ..........................................................................4-5 4.2.10 NIBP Processing..........................................................................................4-5 4.2.11 SpO2 Processing ..........................................................................................4-6 4.2.12 ECG Processing...........................................................................................4-6 4.2.13 IBP Processing.............................................................................................4-7 4.2.14 Temperature Processing...............................................................................4-7 4.2.15 etCO2 ...........................................................................................................4-7 4.2.16 Power Management .....................................................................................4-8 4.2.17 Nurse Call Contacts.....................................................................................4-9

Chapter 5 G40 System Disassembly

5-1

5.1 Service tools ............................................................................................................5-2 5.2 To remove batteries..................................................................................................5-2 5.3 To remove the AC power connector fuse.................................................................5-3 5.4 To remove the recorder............................................................................................5-3 5.5 To remove the front case assembly..........................................................................5-4 5.6 Front case disassembly procedure ...........................................................................5-6 5.7 Main frame disassembly procedure .........................................................................5-8 5.8 Rear case disassembly procedure ..........................................................................5-17

Contents-3

Contents

Chapter 6 G30 System Disassembly

6-1

6.1 To remove battery ....................................................................................................6-2  6.2 To remove the AC power connector fuse.................................................................6-3  6.3 To remove the recorder............................................................................................6-3  6.4 To remove the front case assembly..........................................................................6-4  6.5 Front case disassembly procedure ...........................................................................6-5  6.6 The main frame disassembly procedure ..................................................................6-7  6.7 The rear case disassembly procedure.....................................................................6-15 

Chapter 7 Assembly Diagrams and Service Parts

7-1

7.1 G40 main assembly exploded diagram ...................................................................7-2 7.2 G40 Front Case assembly and parts........................................................................7-4 7.3 G40 rear case assembly and parts ...........................................................................7-6 7.4 G40 main frame assembly and parts.......................................................................7-7 7.5 G30 main assembly exploded diagram .................................................................7-10 7.6 G30 front case assembly and parts........................................................................7-12 7.7 G30 rear case assembly and parts .........................................................................7-14 7.8 G30 main frame assembly and parts.....................................................................7-15

Appendix A Electromagnetic Compatibility

A-1

A.1 Instructions for use................................................................................................A-2 A.2 Guidance and Manufacturer's EMC Declaration ..................................................A-3 A.2.1 Electromagnetic Emissions for all Equipment and Systems ......................A-3 A.2.2 Electromagnetic Immunity for all Equipment and Systems .......................A-3 A.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting .............................................................................................................................A-5 A.2.4 Recommended Separation Distances..........................................................A-6

Contents-4

General Introduction

Chapter 1 General Introduction This chapter briefly introduces the monitor and related product support information.

1.1 About the Guide.......................................................................................1-2 1.1.1 Brief Introduction ...........................................................................1-2 1.2 Product Information.................................................................................1-2 1.2.1 General ...........................................................................................1-2 1.2.2 Main Components ..........................................................................1-2 1.2.3 Intended Use...................................................................................1-3 1.2.4 Audience.........................................................................................1-3 1.2.5 Networking Capabilities.................................................................1-3 1.3 Before You Begin....................................................................................1-4 1.4 Monitor and Accessories Inspection........................................................1-4 1.5 Cleaning...................................................................................................1-5 1.6 Returning the Monitor For Service..........................................................1-5 1.7 Setting up the Monitor.............................................................................1-6 1.8 Before Powering On ................................................................................1-6 1.9 Setting Demo Mode.................................................................................1-7 1.10 Setting the Networking..........................................................................1-8

1-1

General Introduction

1.1 About the Guide 1.1.1 Brief Introduction This guide gives a brief introduction on maintenance of the G30/G40 patient monitors, which is to be used by professionals responsible for servicing and maintaining the patient monitors. This document and the information contained in it is proprietary and confidential information of Goldway and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Goldway.

1.2 Product Information 1.2.1

General The monitor collects the physiological signals of ECG, RESP, TEMP, NIBP, SpO2, IBP, and CO2, and converts the above into digital data which is analyzed and displayed. You may not have all of these functions, depending on the monitor configuration purchased.

1.2.2

Main Components The monitor can contain these components: • Main unit • ECG • RESP • NIBP • SpO2 • TEMP • CO2 • IBP • Recorder

1-2

General Introduction

Table 1-2 Monitor Configurations G30

G40

●

●

●

●

RESP

●

●

NIBP

●

●

SpO2

●

●

CO2

○

○

IBP1 IBP2

○

○

Arrhythmia analysis

●

●

ST segment analysis

●

●

Recorder

○

○

ECG (3, 5 leads) TEMP1 TEMP2

Display Screen, Resolution Max. Number of Batteries Maximum Waveform Channels

10.4 inches, 800×600

12.1 inches,800×600

1

2

8

8

● indicates standard configuration; ○ indicates optional configuration

1.2.3

Intended Use For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations and for connectivity to clinical networks.

1.2.4

Audience This guide is for biomedical engineers or technicians responsible for troubleshooting, repair and maintenance of Goldway patient monitors.

1.2.5

Networking Capabilities You can use the G30/G40 Patient Monitors along with other Goldway equipment to create a central monitoring system that allows remote monitoring. The monitor communicates with the UT4800 Central Monitoring System via an RJ45 port on the back of the monitor. 1-3

General Introduction

1.3 Before You Begin Before you start using the monitor: 1. Unpack the equipment and make sure that you have the following: – 1 patient monitor – Instructions for Use – Service Guide CD – AC power cord (country-specific) – Set of accessories If anything from the packing list is missing, immediately contact Goldway or a Goldway agent.

2. Keep the packaging for future transport or storage. If it is damaged, immediately contact the courier company.

3. Examine the monitor for cleanliness and general physical condition. Make sure that the: – Housing is not cracked or broken. – Power plugs and cords are in good condition and plug prongs are not bent. – External cables and accessories are in good condition and that the insulation is intact.

Caution

If the equipment or packaging show signs of damage, do not use the equipment.

1.4 Monitor and Accessories Inspection 1. Before turning on the power, check the monitor and accessories to make sure there is no damage and the extension cables are correctly connected to the fittings. 2. Plug one end of the power cord into an AC power supply with a protective grounding wire. Plug the other end into the power connector on the monitor. If the monitor is powered by batteries, make sure enough power remains. 3. Power on the monitor and enter the main screen after the start-up screen. 4. Ensure that the patient cable and sensors are correctly connected. 5. Ensure that all settings like patient type, alarm limits, and so on, are correct. 6. Test the measurements and verify that the monitor is working correctly.

1-4

General Introduction

Warning

Never attempt to open the monitor case. Only qualified personnel should service the monitor. Only use the instructions in this guide to install and use the monitor.

Caution

To maintain normal operation of the monitor, develop a good maintenance plan for periodic cleaning, maintenance and service. For more information, see Chapter 2 Maintenance.

1.5 Cleaning Caution

Do not immerse the monitor or its accessories in liquid or clean it with caustic or abrasive cleaners. Do not spray or pour any liquid on the monitor or its accessories. To clean the monitor: 1. Dampen a cloth with a commercial, nonabrasive cleaner, and wipe the exterior surfaces lightly. 2. Do not allow liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the monitor. 3. For cables, sensors, and cuffs, follow the cleaning instructions in Section 2.5 Cleaning. For more detailed information, see the Maintenance chapter.

1.6 Returning the Monitor for Service If it is necessary to return the monitor for service, call the Goldway Service Department. Have all equipment serial numbers available before calling.

Before returning any equipment to Goldway, decontaminate it first. To pack the monitor for return, disconnect all cables. It is not necessary to return sensors, the temperature probe, NIBP tubing and cuff, or power cord. If available, use the original packaging materials.

Ensure that the monitor transports within the following specifications: Table 1-3 Environmental Specifications Parameter Temperature - working Temperature - storage and transportation Relative humidity - operating Relative humidity - storage and transportation Barometric pressure - working Barometric pressure - storage and transportation

1-5

Specification 10°C – 40°C (50°F – 104°F) -20°C – 55°C (-4°F – 131°F) ≤ 80% ≤ 95% 70 kPa – 106 kPa 50 kPa – 106 kPa

General Introduction

1.7 Setting up the Monitor Place and use the monitor in any appropriate location that conforms to the environmental specifications in the G30/G40 Patient Monitors Instructions for Use.

Locate the monitor in an area that: • Is convenient for observation and operation • Is free from movement, dust, corrosive or explosive gases • Has a five centimeter space around to ensure good ventilation and smooth heat dissipation

Caution

Only install the monitor as outlined in this Service Guide. Never block the monitor’s air vent during operation. Always keep the monitor free from condensation and temperature changes when transporting it from one location to another. You can put the monitor on a flat surface or mount it using the bedrail hooks. To mount, place the monitor bedrail hooks over a secure horizontal bedrail.

Warning

Never place the monitor in a location where the patient might inadvertently knock it off the bed.

1.8 Before Powering On Warning

Never disassemble the monitor before unplugging the power cable from the AC power source or from the AC power connector on the side of the monitor. After connecting the monitor to an AC power source, it can be put into operation. Before turning on the monitor: 1. Ensure that the AC power source complies to any AC power regulations.

Note — Only connect the monitor to a power outlet with correct protective grounding. If no grounded power is available, only use the monitor with internal batteries. 2. Connect the power cord to the monitor and to a single-phase AC power source. 3. Check that the power light on the front panel is yellow.

This means that the AC power is correctly connected.

1-6

General Introduction

Warning

Personnel connecting additional devices to input and output connectors are responsible for system compliance with the IEC 60601-1-1 standard. If you cannot determine the safety of the monitor when combining it with another medical device, contact Goldway to ensure that the combined devices are safe and will not cause electric shock or other hazards. When safety (for example an electrical shock caused by the sum of current leakage) can not be determined from the specific combination of the monitor and other medical devices, please contact service representative, to ensure necessary safety.

1.9 Setting Demo Mode Demo mode lets you demonstrate the monitor without monitoring parameters. Demo mode does NOT generates alarms when alarm settings are exceeded. To set the Demo mode: 1. Press the Main Menu key on the front panel. 2. Rotate the navigation wheel to System menu and press the navigation wheel. 3. The System menu appears, and then rotate the navigation wheel to Demo then press the navigation wheel. 4. The Logging On menu appears and rotate the navigation wheel to the Password, press the navigation wheel. A password window appears. Enter the password (8727) by turning the wheel to select the digit, and then press the wheel to save the first digit. Repeat this for the next three digits of the password. 5. Press OK.

1-7

General Introduction

1.10 Setting the Networking To set the Networking: 1. Press the Main Menu key, the Main Menu window appears. 2. Rotate the navigation wheel to the System button, press the wheel, the System menu window appears. 3. Rotate the wheel to the Networking Connection button, press the wheel, the Networking Connection window appears. 4. Rotate the wheel to the Network Port button, and press the wheel to select it. 5. Rotate the wheel to the Networking Setup button, press the wheel, the Networking Setup window appears. 6. Rotate the wheel to the Host IP button, press the wheel, and rotate the wheel to enter the Host IP. Repeat this to enter the Service IP, Netmask, Gateway. 7. Rotate the wheel to the Port button. Enter the Port number for service. The default value is 8010. 8. The Wireless selection NO. 9. The DHCP selection YES is to get the Service IP automatically; No is to enter the Service IP manually. 10. The Broadcast IP and the Mac ID is for Factory Setting. 11. Rotate the wheel to the OK press the wheel to save the setting.

1-8

Maintenance

Chapter 2 Maintenance This chapter describes how to inspect and maintain the G30/40 Patient Monitors.

2.1 Testing and Inspection Guidelines......................................................................2-3 2.2 Maintenance Plan ...............................................................................................2-4 2.2.1 Visual Inspection .......................................................................................2-4 2.2.2 Cleaning.....................................................................................................2-4 2.2.3 Performance Verification...........................................................................2-4 2.2.4 Leakage Current Test.................................................................................2-4 2.2.5 NIBP Calibration .......................................................................................2-4 2.2.6 CO2 Gas Measurement Calibration Check ................................................2-5 2.2.7 IBP Calibration ..........................................................................................2-5 2.3 Visual Inspection ................................................................................................2-6 2.4 Cleaning..............................................................................................................2-6 2.4.1 General Guidelines ....................................................................................2-6 2.4.2 Cleaning and Disinfecting .........................................................................2-7 2.4.3 Cleaning the Cables...................................................................................2-7 2.4.3.1 Cleaning the Accessories ........................................................................2-7 2.4.3.2 SpO2 Accessories....................................................................................2-8 2.4.3.3 NIBP Cuffs .............................................................................................2-9 2.4.3.4 Temperature Accessories ........................................................................2-9 2.4.3.5 Cleaning the Recorder ............................................................................2-9 2.4.3.6 Disinfecting Guidelines ........................................................................2-10 2.5 Performance Verification Testing ..................................................................... 2-11 2.5.1 Manufacturer’s Responsibility ................................................................ 2-11 2.5.2 Recommended Frequency ....................................................................... 2-11 2.5.3 Required Test Equipment ........................................................................2-12 2.5.4 Testing Record.........................................................................................2-13 2.5.5 Power Supply and Battery Test................................................................2-13 2.5.6 ECG Test .................................................................................................2-14 2.5.7 Respiration Test .......................................................................................2-14

2-1

Maintenance

2.5.8 Temperature Test .....................................................................................2-14 2.5.9 IBP Test ...................................................................................................2-15 2.5.10 Pulse SpO2 Test .....................................................................................2-15 2.5.11 NIBP Test...............................................................................................2-15 2.5.12 Speaker Test...........................................................................................2-17 2.5.13 Networking Test ....................................................................................2-17 2.6 Electrical Safety Test ........................................................................................2-18

2-2

Maintenance

2.1 Testing and Inspection Guidelines The following table lists the tests that Goldway requires to be completed after performing monitor installations, repairs, or software upgrades. Table 2-1 Testing and Inspection Guidelines

After …

Complete These Tests …

Installing

Visual inspection

Upgrading the software

Power Supply and Battery Test

Opening the monitor for any

Speaker Test

reason

Power Supply and Battery Test NIBP Test All safety tests

Replacing any internal parts

Power Supply and Battery Test

(except SpO2, CO2, ECG,

NIBP Test

TEMP, IBP/TEMP module)

Speaker Test All safety tests

Replacing the ECG module

Power Supply and Battery Test ECG test Speaker Test Respiration Test All safety tests

Replacing the SpO2 module

Power Supply and Battery Test Pulse SpO2 Test All safety tests

Replacing the IBP/TEMP

Power Supply and Battery Test

module

IBP Test IBP Calibration Temperature Test All safety tests

Replacing the TEMP module

Power Supply and Battery Test Temperature Test All safety tests

Replacing the CO2 module

Power Supply and Battery Test Speaker Test All safety tests 2-3

Maintenance

2.2 Maintenance Plan To maintain proper performance of the monitor, a good maintenance plan must be made. We recommend the following:

2.2.1 Visual Inspection Before use, operator shall first inspect the outside appearance of the equipment. Service personnel shall first inspect the outside appearance of the equipment before maintenance.

2.2.2 Cleaning Maintenance personnel shall clean the equipment after maintenance.

2.2.3 Performance Verification When monitor is received, a qualified person must inspect the monitor thoroughly and verify its performance. Service personnel shall inspect the monitor thoroughly and verify performance every time maintenance is done or every 12 months.

2.2.4 Leakage Current Test Service personnel shall inspect the monitor thoroughly every time when maintenance is done or every 12 months.

2.2.5 NIBP Calibration An authorized service representative must perform pressure tests and parameter calibration every 12 months or whenever you suspect incorrect blood pressure readings. Always check to see if the cuff or hose has a leak.

Replace the cuff or hose as necessary. If a pressure reading, when compared with a precise blood pressure meter, differs by more than 3% (beyond the range of ±3mmHg), the monitor needs pressure calibration. Authorized personnel can perform the required calibrations.

2-4

Maintenance

2.2.6 CO2 Gas Measurement Calibration Check To check the calibration of the CO2 gas measurement: 1. Press the Param Menu key, rotate the navigation wheel to CO2 Setup, press the wheel, the CO2 Setup menu appears. 2. Rotate the wheel to the Work Mode button, press the wheel. The Work Mode menu appears. 3. Rotate the wheel to select the Work Mode, and then exit. 4. Rotate the wheel to the CO2 Calibration button, press the wheel, the CO2 Calibration window appears. 5. Connect one end of the Filter Line tubing to the CO2 inlet on the monitor; leave the other end unconnected. 6. Connect the other end of the Filter Line tubing to the gas controller equipment inlet with a 5% gas concentration. 7. Open the valve on the gas controller equipment to allow 5% CO2 gas to flow into the monitor. 8. In the CO2 Calibration window, rotate the wheel to the Two-Point Calibration, press the wheel to start calibration. The calibration message is displayed in the CO2 Calibration window. Note —

The calibration may take up three minutes to complete. 9. If calibration is successful, rotate the wheel to the Exit to leave the test.

2.2.7 IBP Calibration To calibrate the IBP: 1. Connect one end of the IBP accessory to the IBP inlet on the monitor; leave the other end unconnected. 2. Press the Param Menu key, rotate the navigation wheel to IBP1 Setup, press the wheel, the IBP1 Setup menu appears. 3. Rotate the wheel to the IBP Calibration, press the wheel to start calibration to the atmospheric pressure. Note —

The IBP calibration can take up several seconds to complete. 4. Repeat the above steps to calibrate the IBP2.

2-5

Maintenance

2.3 Visual Inspection Before using the monitor, make sure to inspect the monitor carefully:

1. Carefully inspect the outside of the monitor, display and control parts to see if there is any apparent physical damage. If yes, do not use the monitor. Please contact an authorized service personnel and reflect the damage until problems are settled before connect the monitor to patients.

2. Inspect all cables, connecting wires and external connectors. If there is any damage, do not use the monitor. Please contact authorized service personnel and reflect he damage until the problems are settled before connecting the monitor to patients.

3. Inspect to see if the safety marks on the equipment are faded.

2.4 Cleaning This chapter gives general guidelines on the cleaning and care of your monitor and accessories. Use only the approved cleaning methods and agents listed in this chapter. The warranty does not cover damage caused by using unapproved substances. Cleaning methods described in this chapter have been tested by Goldway. Other methods and cleaning agents may contaminate or damage the monitor. In addition, qualified professionals should perform calibration and maintenance of the monitor periodically.

2.4.1 General Guidelines Keep the monitor, cables and accessories free of dust and dirt. After cleaning and disinfecting, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Goldway, decontaminate it first.

Follow these general precautions: • Always dilute cleaning agents according to the instructions in this chapter or use the lowest possible concentration. • Never let liquid enter the monitor case. 2-6

Maintenance

• Never immerse any part of the equipment in liquid or allow any liquid to enter electrical contacts. • Never use abrasive material (such as steel wool or silver polish). • Never use bleach, strong solvents, or acetone on any part of the monitor • Never autoclave, steam sterilize, or ultrasonically clean the monitor or cables • Never use alcohol on the patient cables. Alcohol can cause the plastic to become brittle and fail prematurely.

Caution

If you see any sign of deterioration or damage on any accessory, do not use it, and replace it with a new one. Use the equipment according to instructions accompanied with the sensors. The manufacturer information might be more current. If you spill liquid on the exterior of the monitor, use a clean cloth to dry the monitor. If you believe the liquid may be inside the monitor, power off the monitor and contact your service representative.

2.4.2 Cleaning and Disinfecting To clean the monitor: 1. Turn off the patient monitor and unplug the power cord. 2. Clean the monitor casing and screen with a cloth moistened with liquid detergent or one of the following cleaning agents: – Mild soap – Alconox dish washing detergent – Ammonia, 3% and window detergent – Ethanol 70%, 70% isopropyl alcohol, window detergent. 3. Air dry the cleaned parts or use a cloth.

2.4.3 Cleaning the Cables To keep the cables free from dust: 1. Use a lint-free cloth dampened with warm water (maximum 40°C/104°F) and soap or a diluted non-caustic detergent. 2. Dry the equipment with a soft cloth. 2.4.3.1 Cleaning the Accessories When possible, clean the accessories according to the manufacturer’s instructions. Use the general guidelines in this chapter if you do not have specific product cleaning instructions. 2-7

Maintenance

2.4.3.2 SpO2 Accessories SpO2 reusable sensors should be cleaned and disinfected, but never sterilized. Warning

Use only the validated cleaning agents and disinfectants listed below. Using other agents may damage the sensor or its connecting wires, shorten product lifetime, or cause safety hazards. Select disinfectants carefully as some have very similar names but very different compositions. Never immerse the sensor connector in any of the cleaning solutions, disinfectants, or other liquids. The sensor and cable housing may be immersed, however. Never soak sensors in disinfectants longer than specified by the disinfectant manufacturer. Never sterilize or autoclave the sensors.

Validated Cleaning Agents • Mild detergent • Salt solution (1%) Validated Disinfectants • Metricide® 28 • Cidex® Formula 7 • Kohrsolin® (2%) • Metricide® Plus 30 • Cidex® OPA • Mucapur®-CD (1%) • Terralin® Liquid • Cidex® Plus • Isopropanol (70%) or Isopropanol Wipes (70%) • Incidin® Liquid • Omnicide® 28

To clean and disinfect the sensor: 1. Clean the sensor according to the instructions supplied with the cleaning agent. 2. Disinfect the sensor according to the instructions supplied with the disinfectant. 3. Wipe the exterior surfaces lightly. Do not allow liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the monitor. 4. Dispose of any sensor showing signs of deterioration or damage.

2-8

Maintenance

2.4.3.3 NIBP Cuffs To clean the cuff: 1. Remove the bag from inside the cuff. 2. Clean the cuff in detergent (mild soap water) and air dry it. 3. Check the cuff and tube. To sterilize the cuff to avoid cross-infection: 4. Disinfect the cuff in an autoclave or immerse it into one of the following detergents: 70% isopropanol or 70% ethanol To put the rubber inflation bag back into the cuff: 1. Roll the bag from both ends in the direction of the tube. 2. Insert the rolled bag from the tube side into the opening on the short side of the cuff. 3. Push the tube through to the other side of the cuff. 4. Hold the tube together with the cuff and shake the whole cuff until it reaches the bag. Note — Never dry-clean the cuff.

2.4.3.4 Temperature Accessories Clean the temperature sensor after each use. To clean the temperature sensor: 1. Hold the probe with one hand and clean the sensor from the top with a wet lint- free cloth dampened with isopropanol. 2. In addition, regularly disinfect the sensor with ethylene oxide. 3. Use a dry cloth to clean the surface of the temperature sensor. 4. Check the temperature sensor and do not use it if you see any signs of damage or deterioration.

Caution

Never heat the sensor to over 100°C (212°F). Only heat it to 80°C (176°F) - 100°C (212°F) for a short time.

2.4.3.5 Cleaning the Recorder After extended use, deposits of paper debris may collect on the print head making recordings uneven and faint, shortening the life of the print head and the roll shaft. 2-9

Maintenance

To clean the print head: 1. Apply an anti-static agent to the recorder door, and then open the door. 2. Remove the paper roll from the recorder. 3. Thread a cloth cleaning strip around the roller until the strip comes out of the top of the roller. 4. Pull the strip through the roller. 5. Clean the roller housing gently with a soft cloth. 6. Soak a cotton swab in alcohol and gently wipe the surface of the thermal printer head. 7. Reload the paper roller after the alcohol is dried and close the recorder door. Caution

Always apply an anti-static agent to protect against ESD damage.

2.4.3.6 Disinfecting Guidelines To avoid long-term damage to cables, do not disinfect a cable unless directed by the hospital. Always shut off the monitor and clean it before performing any disinfection.

Do not use strong solvents for disinfection. Always dilute cleaning agents according to the manufacturer’s instructions or use the lowest possible concentration. Disinfect the equipment with a cloth moistened with these materials. – 70% ethanol, 70% isopropyl alcohol – Acetaldehyde: Cidex

Caution

When disinfecting any accessories, follow the manufacturer’s instructions; otherwise, use the disinfection agents listed in this chapter.

2-10

Maintenance

2.5 Performance Verification Testing 2.5.1 Manufacturer’s Responsibility If hospital staff did not observe the maintenance plan, which leads to inaccurate measurement of the monitor or potential hazards to operators or patients, unless otherwise agreed by both parties, manufacturer shall not undertake any responsibilities. All responsibilities shall be undertaken by the user of the monitor.

2.5.2 Recommended Frequency Perform the test procedures at the recommended frequency outlined in the following table. Caution

The frequency recommendations in the following table do not supersede local requirements. Always perform locally required testing in addition to the testing outlined in the table. Table 2-2 Recommended Frequency

Suggested Testing

Frequency

Preventive Maintenance NIBP calibration

Once a year, or more often if specified by local laws.

CO2 Gas Measurement Calibration

First calibration at 1,200 hours of continuous use. After first calibration, once a year or after 4,000 hours — whichever comes first. Perform following any instrument repairs or the replacement of any instrument parts. Replace entire CO2 module after 20,000 hours continuous use.

Performance IBP Test

Once a year, or if you suspect the measurement is

NIBP accuracy test

incorrect.

Pulse SpO2 Test

CO2 accuracy

Once a year.

Safety

Once every two years and after repairs where the unit

In accordance with IEC 60601-1

has been opened (front and back separated) or the

• System enclosure leakage current

monitor has been damaged by impact.

• Ground integrity • Patient leakage current

2-11

Maintenance

2.5.3 Required Test Equipment The following table lists the additional test equipment that you need to perform each of the tests in this chapter. Many of these tests also use the standard accessories that are shipped with the monitor. Multi-functional simulator, ECG trunk cable, 5-lead ECG lead set, blood pressure cuff, TEMP probe, digital pressure meter, SpO2 simulator and SpO2 sensor. Table 2-3 Required Test Equipment To Perform This Test …

You Need This Test Equipment …

Visual Test

None

Power Supply and Battery Test

None

Speaker Test

None

Pulse SpO2 Test

• Adult SpO2 sensor

ECG Test / Respiration Test

• Patient simulator • ECG trunk cable and lead set

NIBP Test

• Reference manometer (includes hand pump and valve), accuracy 0.2% of reading • Expansion chamber (volume 500 ml +/10%) • Appropriate tubing

NIBP Calibration

None

IBP Test

• Patient simulator

IBP Calibration

None

CO2 Gas Measurement Calibration

• Standard tools • Electronic flow meter • Gas calibration equipment: – Cal gas (5% CO2) – Cal gas flow regulator – Cal tube Patient simulator (with 0.1oC or 0.2oF) or

Temperature Test

measurement server extension Safety Tests

• Multimeter

2-12

Maintenance

2.5.4 Testing Record Authorized Goldway personnel report test results back to Goldway to add to the product development database. Hospital personnel, however, do not need to report results. The following table describes what to record on the service record after you complete the tests in this chapter. Table 2-4 Testing Record

Test

What to record

Visual

V:P or V:F

Power

PO:P or PO:F

NIBP

NIBP:P/X1/X2/X3 or NIBP:F/X1/X2/X3

CO2

CO2 cal: P or CO2 cal: F

Safety

S(1):P/X1/X2 or S(1):F/X1/X2 S(2): P/X1 or S(2): F/X1 S(3): P/X1 or S(3): F/X1

Note: P = pass, F = fail, X = measured value as defined in tests in this chapter

2.5.5 Power Supply and Battery Test 1.

Connect power cable between the wall outlet and monitor power connector and power the monitor up.

2.

Check if the power indicator lights up and the indicator color.

3.

Green: The monitor is powered on and in normal working status.

4.

Yellow: The monitor is connected to AC power but not turned on. It is under internal battery charging status.

5.

Press the stand-by key of the monitor to turn on the monitor and unplug the power cable. Inspect if the power indicator is green and if a battery mark displaying in the status box on the screen, showing that the monitor is powered by batteries.

2-13

Maintenance

2.5.6 ECG Test 1.

Set the ECG simulator as follows:

2.

Heart rate: 80bpm; ECG gain: 1mV

3.

Connect one end of the ECG cable to the ECG connector of the monitor and the other end to the simulator.

4.

Confirm if patient simulator has been connected properly to the monitor.

5.

Observation: ECG lead II is displayed in the ECG channel, without noise. Heart rate display: 80±2bpm. When R wave appears, you can hear a “beep”.

6.

Check every ECG lead to see if there is any ECG waveform and noise interference.

7.

Adjusting ECG gain to 2mV, observe if there is any change in ECG waveform.

8.

Unplug the RA from simulator, and then observe if the screen prompts “lead off”.

9.

Reconnect RA lead.

10.

Set 1mV calibration in the ECG setting menu, and observe if a 1mV calibration square wave is overlapped over the ECG waveform.

11.

ECG test is complete.

2.5.7 Respiration Test 1.

Connect ECG cable to the ECG socket properly.

2.

Set the simulator as follows: respiration baseline resistance: 500 Ohm, Respiration Delta R: 0.5 Ohm, Respiration lead: I or II. Respiration rate: 30bpm

3.

Set monitor respiration lead to be RA-LA or LL-RL and set respiration waveform channel.

4.

Observe if respiration parameter area displays reading 30±2rpm, waveform channel displays respiration waveform.

5.

Change monitor respiration lead and observe the above parameter and waveform.

6.

Unplug ECG cable and respiration test is complete.

2.5.8 Temperature Test 1. Connect the patient simulator to the temperature connector on the monitor. 2. Configure the patient simulator to 40 oC (100 oF). 3. Wait for the monitor to display the static temperature value. 4. The value should be 40 oC ± 0.2 oC (100 oF ± 0.4 oF).

2-14

Maintenance

2.5.9 IBP Test IBP test is suitable for monitors with IBP function 1.

Set the simulator to: IBP output ATM;

2.

Connect the IBP cable to the IBP1 socket on the simulator and the other one to IBP1 socket on the monitor.

3.

Reset the monitor by resetting the IBP setting.

4.

Select ART. Check if there is IBP measurement in the IBP area of the monitor, and also check if the IBP waveform is shown in the relevant channel (the channel should be set in settings)

5.

Change the IBP output of the simulator to 200mmHg;

6.

Verify that the number on the screen is 200 ± 5mmHg;

7.

Unplug the cable between the monitor and the simulator to finish the IBP test.

2.5.10 Pulse SpO2 Test 1. Connect an adult SpO2 transducer that you know to be working correctly to the SpO2 connector on the monitor. Ensure that the red LED in the sensor in the transducer is lit. 2. Connect the other end of the transducer to your finger (this assumes that you are healthy). 3. Verify that the SpO2 value displayed on the monitor is between 95% and 100%. If it is not, try the test again with a patient simulator.

2.5.11 NIBP Test Before you start, see Required Test Equipment for a list of the equipment that you need to perform this test. These tests check the performance of the non-invasive blood pressure measurement. Perform each of these NIBP checks and procedures when checking the NIBP unit: • NIBP accuracy • NIBP calibration procedure (if required) • NIBP overpressure valve

2-15

Maintenance

To test NIBP accuracy: 1. Connect the manometer and the pump with tubing to the NIBP connector on the G30/G40 Patient monitor. 2. Connect the tubing to the expansion chamber (500ml cylinder).

Figure 2-1 Connect the Tubing

3. Press the Main menu key, the Main Menu window appears. Rotate the wheel to the System button, press the wheel. 4. Rotate the wheel to the System Maintenance ..., enter this menu. 5. Rotate the wheel to the Pressure Test, press the wheel to start test. 6. Squeeze the manometer pump and apply a pressure of 50mmHg. 7. Note the pressure displayed in the NIBP Test window and record this result as X1 (see Test Recording). It should be 50mmHg +/- 3mmHg. 8. Squeeze the manometer pump to apply a pressure of 250mmHg to the monitor. 9. Note the pressure displayed in the NIBP Test window and record this result as X2. The pressure in the NIBP Test window should be 250mmHg +/- 3mmHg. 10. Press the NIBP button to stop the test. 11. If the difference between the manometer and displayed values is greater than 3mmHg, calculate the difference by the following formula, and then calibrate the monitor. Vadj = [(X1 – 50) + (X2 – 250)] / 2 Note: You need to round up the result.

12. If the difference between the manometer and displayed values is not greater than 3mmHg, skip to the “To Test the Overpressure”.

2-16

Maintenance

To Calibrate the NIBP: 1. Press the Main menu key, the Main Menu window appears. Rotate the wheel to the System button, press the wheel. 2. Rotate the wheel to the System Maintenance ..., enter this menu. 3. Rotate the wheel to the Pressure Compensation. Press the wheel, the Pressure Compensation window appears. 4. Rotate the wheel to select the appropriate value (Vadj). 5. Exit.

To Test the Overpressure: 1. Press the Main menu key, the Main Menu window appears. Rotate the wheel to the System button, press the wheel. 2. Rotate the wheel to the System Maintenance ..., enter this menu. 3. Rotate the wheel to the Pressure Test, press the wheel to start test. 4. In the Adult, squeeze the manometer pump and apply a pressure of 290mmHg. 5. Verify the valves open, releasing the pressure on the manometer. 6. In the Neo., squeeze the manometer pump and apply a pressure of 150mmHg. 7. Verify the valves open, releasing the pressure on the manometer.

2.5.12 Speaker Test 1. Turn on alarm sound and set Heart Rate alarm limits. Test if the monitor would make alarm sound when heart rate is out of the alarm limits. 2. Silence alarm sound and test if the monitor will make alarm sound when heart rate is out of the alarm limits. 3. Turn on the alarm sound. Speaker test is complete.

2.5.13 Networking Test After monitor is networked with the UT 4800 Central Monitoring System, inspect if the ECG waveform and its parameters are correctly displayed at the Central Monitoring System display.

2-17

Maintenance

2.6 Electrical Safety Test Electrical safety test inspects whether the monitor has potential hazards to patients or operators.

In order to establish a systematic maintenance plan, we recommend all safety tests and records shall be made under the following circumstances: every year, and the monitor is opened for repair.

Use the following safety test procedures for verifying safe installation or service of the monitor. The setups used for these tests and the acceptable ranges of values are derived from local and international standards but may not be equivalent. These tests are not a substitute for local safety testing where it is required for an installation or a service event. If using the Metron Safety tester, perform the tests in accordance with your local regulations, for example in Europe use IEC60601-1/IEC60601-1-1. The Metron Report should print results with the names listed below, together with other data.

The monitor safety tests include: • System Enclosure Leakage • Ground integrity • Patient leakage current with mains voltage

System Enclosure Leakage S(1) Part 1: System Enclosure Leakage Current - NC (normal condition)

2-18

Maintenance

Expected Test Results Normal condition maximum leakage current x1 ≤ 100µA This measures leakage current of exposed metal parts of Instrument under Test (IUT) and between parts of the system within the patient environment; normal and reversed polarity using S2. Safety test according IEC 60601-1 / UL2601-1

S(1) Part 2: System Enclosure Leakage current - Single Fault (open earth)

Expected Test Results Single Fault maximum leakage current x2 ≤ 500µA (IEC 60601-1)≤ 300µA (UL2601-1) This measures leakage current of exposed metal parts of Instrument under Test (IUT) with Protective Earth (PE) open circuit (S4 = open) and between parts of the system within the patient environment; normal and reversed polarity using S2.

S(2) Protective Earth Continuity

2-19

Maintenance

Expected Test Results With mains cable, maximum impedance x = 100 mOhms (IEC 60601-1 and UL2601-1) This measures impedance of Protective Earth (PE) terminal to all exposed metal parts of Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth (PE). Test current 25 Amp applied for 5 to 10 seconds.

Patient Leakage Current with Mains Voltage S(3) Patient Leakage current - Single Fault Condition (S.F.C.) mains on applied part

Expected Test Results Maximum leakage current, x = 50µA @ 250V (IEC60601-1 and UL2601-1) Measures patient leakage current from applied Part to earth caused by external main voltage on applied Part with switch S5 open and closed. Each polarity combination possible is tested using S2 and S6. This test is applicable for every measurement input.

2-20

Troubleshooting

Chapter 3 Troubleshooting This chapter describes how to troubleshoot monitor problems. After using this chapter to diagnose a problem, see Chapter 5(G40) or Chapter 6(G30) to repair the monitor or to remove and replace a part or assembly. 3.1 Power Problems ................................................................................ 3-2 3.2 Display Problems .............................................................................. 3-9 3.3 Alarm Problems............................................................................... 3-10 3.4 NIBP Problems................................................................................ 3-10 3.6 Temperature Problems......................................................................3-11 3.7 SpO2 Problems .................................................................................3-11 3.8 etCO2 Problems ................................................................................3-11 3.9 ECG/Respiration Problems ............................................................. 3-12 3.10 Recorder Problems ........................................................................ 3-13 3.11 Performance Verification Testing .................................................. 3-14

3-1

Troubleshooting

3.1 Power Problems Symptom I can’t turn on the monitor with AC Power, but can with battery power.

Possible cause The cord is unplugged or broken. The fuse is blown.

The AC/DC Power Module cable has malfunctioned.

The AC/DC Power Module has malfunctioned.

The AC power connector has malfunctioned.

The monitor front case assembly is worn.

The Main board module has malfunctioned.

I can turn on the monitor with AC Power, but not battery power.

The battery has run out.

The battery or connector is loose. The battery does not have a connection to the Main board module. The Main board module has malfunctioned.

I can’t get the monitor to turn on with either AC or battery power.

The LCD, cables, battery, AC/DC Power Module, or main PCB has malfunctioned.

3-2

Action Ensure that the AC power cord is plugged into an outlet. Replace the fuse. See “To remove a Power Connector Fuse” in Chapter 5 (G40) or Chapter 6 (G30). Replace the DC cable. See “To remove the AC/DC Power Module” in Chapter 5 (G40) or Chapter 6 (G30). Check output voltage on AC/DC Power Module. If you do not capture 15 V, replace the AC/DC Power Module. See “To remove the AC/DC Power Module” in Chapter 5 (G40) or Chapter 6 (G30). Replace the AC connector. See “To remove the Front Case” in Chapter 5 (G40) or Chapter 6 (G30). Replace the front panel. See “Front case disassembly procedure” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Main board module. See “To remove the Main board module” in Chapter 5 (G40) or Chapter 6 (G30). Charge the battery. For more information, see “To remove Batteries” in Chapter 5 (G40) or Chapter 6 (G30). Reseat both the battery and battery cable. Replace the battery board. See “To remove the Battery Board” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Main board module. See “To remove the Main board module” in Chapter 5 (G40) or Chapter 6 (G30). Follow the steps in the decision trees in the following power problem processing.

Troubleshooting

Preparation before troubleshooting: 1. One good battery with enough charge (not fully charged) and a good fuse 2. Battery’s voltage: must be above 11V 3. Standard tools 4. Verify that supply mains is OK (measure by Multimeter) Figure 3-1 Diagram for Power Problem Processing (1)

3-3

Troubleshooting

Figure 3-2 Diagram for Power Problem Processing (2) Can power on by AC, but can not by batteries

Replace a good battery and try again without AC.

Can the monitor be power on?

No

Measure the good battery’s voltage and record; then replace the battery.

Yes

Measure the good battery’s voltage and record; then replace the battery.

Plug in AC and wait about 10 minutes without power on monitor

Remove good battery and measure its voltage again

Figure 3-5 No

Does the voltage increase?

Open the monitor and check the battery board connector J200’s voltage T2/T3

Yes plug in the original batteries with AC in, wait 10 minutes, then try to power on the monitor

Is the voltage of T2/T3 the same as the good battery’s Yes

Can the monitor be powered on? No

Replace main module assembly

Replace the battery board

Yes The problem is only that the batteries did not charge- no fault.

3-4

No The battery has malfunctioned

Troubleshooting

Figure 3-3 Diagram for Power Problem Processing (3)

Can power on by batteries, but can not by AC

Figure 3-6

Check AC Power cable and fuse

No

Are they ok?

Yes

Open monitor and plug in AC, measure J200's voltage T1

Replace

Yes

Is there a voltage about 15V? No

Replace main module assembly

Measure voltage of AC/ DC module’s input

Yes

Is the AC voltage the same as the Supply mains? No Replace AC power assembly

Replace AC/DC module

3-5

Figure 3-5

Troubleshooting

Figure 3-4 Diagram for Power Problem Processing (4) Can not power on by batteries or AC

Try to power on the monitor and listen

Yes

Is there a tone or any sound from the fan?

No

The screen is black. Power off the monitor and open monitor.

Is the power LED on? Yes

Figure 3-7 Plug out J503 and measure the voltages

Open monitor, check connection between key board and main board

Is it normal?

No

Figure 3-5

Open monitor, plug in AC and good battery check the battery board connector J200’s voltage T1/T2/T3

Yes Replace inverter first and try to power on the monitor again No

Is it ok?

Are any normal?

YES If the problem still exists, replace Display assembly.

Replace Main Board assembly

No

Replace Main Board assembly

Fix it

3-6

Yes No/no one ok

Replace battery board

Troubleshooting

Figure 3-5 Power Connector of the Main Board module.

Table 3-1 Pin definition of J200 T1

T2

T3

Pin1

Pin2

Pin3

Pin4

Pin5

Pin6

Pin7

Pin8

NA

NA

GND

5V

GND

Battery’s

GND

Battery’s

Figure 3-6 Fuse in the AC power assembly

Measure Resistance (Ohm) Measure the resistance value across the fuse. If the value is about zero: The fuse is intact; If the value is much larger than zero: The fuse is defective.

3-7

Troubleshooting

Figure 3-7 The LCD driver connector

Table 3-2 Pin Definition of J503 Pin1

Pin2

Pin3

Pin4

Pin5

Pin6

GND

GND

5V

(signal)

15V

15V

4-8

Troubleshooting

3.2 Display Problems Symptom

Possible Cause

Action

Power is on, but the monitor

There is a bad connection with the backlight LCD

Ensure that there is a proper connection between the cable, LCD, backlight and Main board module. Replace the Display assembly. See “To remove the Display assembly” in Chapter 5 (G40) or Chapter 6 (G30). Replace the inverter. See “To remove the Inverter” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Main board module. See “To remove the Main board module” in Chapter 5 (G40) or Chapter 6 (G30). Open the monitor and reseat the LCD signal cable. See “Front Case Disassembly Procedures” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Display assembly. See “To remove the Display assembly” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Main board module. See “To remove the Main board module” in Chapter 5 (G40) or Chapter 6 (G30). Replace the ARM MODULE. See “To remove the ARM module” in Chapter 5 (G40) or Chapter 6 (G30).

screen is Blank There is a bad LCD.

There is a bad inverter.

The Main board module has malfunctioned.

The monitor displays random/

The LCD cable is not attached correctly

distorted graphics with a white background. The LCD is bad

The Main board module has malfunctioned.

I turn on the monitor and the

The ARM module has malfunctioned.

opening screen and/or color bar starts, but then just hangs. The monitor does not respond to

There is a bad connection to the Main board module.

the navigation wheel or front panel buttons

The monitor keypad or navigation wheel is broken.

The Main board module has malfunctioned.

4-9

Ensure that all connectors to the Main board module are seated correctly. Replace the front case, See “Front Case Disassembly Procedures” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Main board module. See “To remove the Main board module” in Chapter 5 (G40) or Chapter 6 (G30).

Troubleshooting

3.3 Alarm Problems Symptom

Possible Cause

Action

Audible alarms do not sound

There is a bad connection to the speaker. The speaker is bad.

Ensure that the connection to speaker is correct. Replace the speaker. See “Rear case disassembly procedure” in Chapter 5 (G40) or Chapter 6 (G30). Replace the Main board module. See “To remove the Main board module” in Chapter 5 (G40) or Chapter 6 (G30).

The Main board module has malfunctioned.

3.4 NIBP Problems Symptom

Possible Cause

Action

The NIBP cuff does not inflate

The tube or cuff is kinked. There is an air leak in the air tube or cuff.

Straighten the tube or cuff. Replace the cuff and ensure that there is no air leakage in the tube. Replace the NIBP pump module. See “To remove the NIBP Module” in Chapter 5 (G40) or Chapter 6 (G30). Use proper cuff size, ensure proper cuff placement. Ensure that the tube is straight and not kinked. Replace the cuff and ensure that there is no air leakage in tube. Ensure that all external blood pressure reading requirements are met and that the patient is not moving excessively. Replace the NIBP pump module. See “To remove the NIBP Module” in Chapter 5 (G40) or Chapter 6 (G30). Replace the ARM module. See “To remove the ARM module” in Chapter 5 (G40) or Chapter 6 (G30). Use proper cuff size, ensure proper cuff placement. Ensure that all external blood pressure reading requirements are met and that the patient is not moving excessively.

The NIBP module has malfunctioned.

There are no NIBP readings

Wrong cuff size or incorrect cuff placement. The tube is kinked or there is air leakage in the air tube or cuff.

There has been some external problem.

There is an NIBP module error.

The ARM module has malfunctioned.

I’m getting unreliable NIBP readings

Wrong cuff size or incorrect cuff placement. There have been some external problems.

4-10

Troubleshooting

3.6 Temperature Problems Symptom

Possible Cause

Action

There are no temperature

The probe lead is off.

readings

The temperature is over range.

Ensure that the temperature probe is connected. Ensure that temperature readings are in the range of 15oC-45oC. Replace the temperature probe. Replace the IBP and TEMP board. See “To remove the IBP and TEMP module” in Chapter 5 (G40) or Chapter 6 (G30). Replace the temperature probe. Replace the IBP and TEMP Module board. See “To remove the IBP and TEMP module” in Chapter 5 (G40) or Chapter 6 (G30).

The probe has malfunctioned. The IBP and TEMP module board has malfunctioned.

I’m getting unreliable temperature readings

The probe has malfunctioned. The IBP and TEMP module board has malfunctioned.

3.7 SpO2 Problems Symptom

Possible Cause

Action

There are no SpO2 readings

The SpO2 sensor has malfunctioned. The SpO2 board has malfunctioned.

Replace the SpO2 sensor.

The ARM module has malfunctioned.

The SpO2 readings are

There has been some external problem.

unreliable

Replace the SpO2 board. See “To remove the SpO2 Board” in Chapter 5 (G40) or Chapter 6 (G30). Replace the ARM MODULE. See “To remove the ARM module” in Chapter 5 (G40) or Chapter 6 (G30). Ensure that all external SpO2 reading requirements are met and that the patient is not moving excessively.

3.8 etCO2 Problems Symptom

Possible Cause

Action

There are no CO2

The CO2 module is initializing.

Wait until initialization is complete. Check the tube to ensure that it is straight. Replace the CO2 module. See “Remove the CO2 module” in Chapter 5 (G40) or Chapter 6 (G30). Replace the ARM module. See “To remove the ARM module” in Chapter 5 (G40) or Chapter 6 (G30).

readings

The CO2 tube is kinked. The CO2 module has malfunctioned.

The ARM module has malfunctioned.

4-11

Troubleshooting Symptom

The

CO2

readings

area

unreliable

Possible Cause

Action

The CO2 tube is kinked.

Check the tube and make sure that it is straight. Ensure that all external CO2 reading requirements are met and that the patient is not moving excessively.

There have been some external problems.

3.9 ECG/Respiration Problems Symptom

Possible Cause

Action

There are no ECG readings

The ECG leads are off.

Ensure that the leads are connected. Ensure that the cable is in good working order. Correct the ECG configuration. Replace the ARM module. See “To remove the ARM module” in Chapter 5 (G40) or Chapter 6 (G30). Replace the ECG board. See “Remove ECG board” in Chapter 5 (G40) or Chapter 6 (G30). Ensure that the ECG leads are connected. Ensure that all external ECG reading requirements are met and that the patient is not moving excessively. Ensure proper skin preparation has been performed. Ensure that the respiration leads are connected. Replace the ECG board. See “Remove ECG board” in Chapter 5 (G40) or Chapter 6 (G30). Ensure that all respiration reading requirements are met and that the patient is not moving excessively. Ensure that the correct ECG lead set is being used.

The ECG cable is broken. The ECG 3/5 lead set is not configured correctly. The ARM module has malfunctioned.

The ECG module has malfunctioned.

I’m getting unreliable ECG

The ECG leads are off.

readings

There has been some external problem.

There

are

no

respiration

The respiration leads are off.

readings

The ECG module has malfunctioned.

The respiration readings are

There has been some external interference.

unreliable

4-12

Troubleshooting

3.10 Recorder Problems Symptom

Possible Cause

Action

The recorder paper is

The paper is not installed correctly. The recorder is using improper paper. The recorder has a mechanical problem.

Remove paper and reinstall correctly. Use only the recommend recorder paper. Replace the recorder module. See “To remove the recorder” in Chapter 5 (G40) or Chapter 6 (G30). Install a new paper supply. Open the recorder door, and then close it again. Check the recorder’s physical connections. See “To remove the recorder” in Chapter 5 (G40) or Chapter 6 (G30). Replace the recorder module. See “To remove the recorder” in Chapter 5 (G40) or Chapter 6 (G30). Replace the ARM module. See “To remove ARM module” in Chapter 5 (G40) or Chapter 6 (G30).

jamming

The recorder does not print

The paper is out and/or the recorder door is open. The system does not recognize the recorder.

The recorder module has malfunctioned.

The ARM module has malfunctioned.

4-13

Troubleshooting

3.11 Performance Verification Testing After repairing the monitor, Performance Verification Testing is recommended. See 2.5 Performance Verification Testing and 2.6 Electrical Safety Test.

4-14

Theory of operation

Chapter 4 Theory of Operation This chapter introduces system theory of operation of G30/G40. 4.1 System Configuration.............................................................................................4-2 4.2 Theory of Operation ...............................................................................................4-3 4.2.1 System Overview.........................................................................................4-3 4.2.2 Block Diagram Components .......................................................................4-3 4.2.3 ARM Module...............................................................................................4-4 4.2.4 Main Board Assembly .................................................................................4-4 4.2.5 I/O Module Assembly..................................................................................4-4 4.2.6 Speaker ........................................................................................................4-5 4.2.7 Recorder ......................................................................................................4-5 4.2.8 AC/DC Power Module ................................................................................4-5 4.2.9 Keys and Navigation Wheel ........................................................................4-5 4.2.10 NIBP Processing........................................................................................4-5 4.2.11 SpO2 Processing ........................................................................................4-6 4.2.12 ECG Processing.........................................................................................4-6 4.2.13 IBP Processing...........................................................................................4-7 4.2.14 Temperature Processing.............................................................................4-7 4.2.15 etCO2 .........................................................................................................4-7 4.2.16 Power Management ...................................................................................4-8 4.2.17 Nurse Call Contacts...................................................................................4-9

4-1

Theory of operation

4.1 System Configuration Display output port

USB Port Only for update

Ethernet port (RJ45 connector)

Nurse call port

ECG analog output port

ARM Module I/O module assembly

Fan

Main CPU Display driver and control

Speaker assembly

Display assembly

Inverter Batteries Main Board assembly AC/DC power module AC power assembly AC socket

Keys Speaker Driver Charge control Inverter control Keys control Power supply to other modules Signals interface

Navigation wheel Front case assembly

Battery LED

Supply mains Power LED

ECG Module

SPO2 Module

NIBP Module

IBP and Temp Module (optional) /Temp Module

4-2

CO2 module (optional)

Recorder (optional)

Theory of operation

4.2 Theory of Operation This chapter contains a high-level overview of the theory of operation of some major functional components of the G30/G40 Patient Monitors.

4.2.1 System Overview This chapter contains a system overview for the G30/G40 Patient Monitors, including a high-level block diagram. This block diagram shows major components of the monitor, including the power supply, NIBP control, SpO2 and CO2 processing, and microcontroller. The monitor is a full function monitor for use on adult, pediatric, and neonatal patients. The functions performed by the system include: • Monitoring patient ECG, heart rate and respiration rate • Blood pressure • Blood oxygen saturation • Carbon dioxide • Temperature In addition to monitoring and displaying the status of physiological parameters, the monitor performs various microprocessor-programmed analytical functions, including • Creating both visual and audible alarm signals when settings are violated • Creating and displaying warning messages when conditions are detected that would degrade or prevent valid measurements • Creating and displaying trend waveforms or tabular data • Providing a synchronizing pulse for defibrillator operation • Providing input to an optional recorder for printout of current or trend waveforms or tabular data The G30/G40 Patient Monitors operate from either an AC power source or battery power. The monitor charges the battery when powered by AC.

4.2.2 Block Diagram Components The G30/G40 Patient Monitors contain several major blocks, including: • Functional module (including ECG, SpO2, NIBP, IBP/TEMP, CO2, Recorder) • ARM Module • Main Board assembly • I/O module assembly • AC/DC power module

4-3

Theory of operation

4.2.3 ARM Module The ARM Module contains these components: • ARM9 microprocessor • Flash memory • SDRAM • Silicon Motion Multimedia Processor • Connectors –Display assembly –Main Board assembly (wire to Main Board assembly) –I/O module assembly (wire to I/O module assembly) • USB • Voltage regulator

4.2.4 Main Board Assembly The system board contains a DC/DC voltage converter, which provides power and communication to: • IBP • ECG • SpO2 • NIBP • IBP/Temp • CO2 • Recorder • ARM board • Inverter • AC/DC power module • Speaker • Keys • Battery charging module

4.2.5 I/O Module Assembly The output interface board provides the connector socket for the following applications: • Display output port • Nurse call port • USB Port • Ethernet port • ECG analog output port 4-4

Theory of operation

• Connection to the ARM Module

4.2.6 Speaker The speaker is driven by an amplifier. The speaker provides the monitor’s audio during alarm conditions. The microprocessor outputs different audio tones specified by different alarm priorities and conditions.

4.2.7 Recorder The recorder contains the following functions: • Motor (paper drive) and driver circuitry • Selectable print speed –12.5mm/s, 25mm/s, Auto • Selectable channel waves to print Print head control logic is implemented on the Main Board. The microprocessor sends data to the recorder via a serial port.

4.2.8 AC/DC Power Module The G30/G40 Patient Monitors contain a medical grade power supply module and circuitry that converts AC (100-240V) to DC (15V). Power consumption is 115 VA.

4.2.9 Keys and Navigation Wheel The keys and navigation wheel generate pulses to the Main Board assembly during use, and the Main Board assembly encodes the message to the ARM module, so the patient monitor can respond to all kinds of operations.

4.2.10 NIBP Processing The NIBP assembly and circuitry contain these elements: • Pump • Valves (2-valve system of dump and safety valve) • Pressure measurement and control circuitry Pressure data is converted to digital format and conveyed to the processor. The NIBP pump uses an oscillometric method that employs stepwise pressure deflation. Pump software eliminates most ambient noise and motion interference. Applications are neonatal, pediatric and adult patients. The blood pressure range is: Systolic, 30-254 mmHg and Diastolic, 10-220 mmHg. Accuracy is Maximum Mean Error ±5 mmHg 4-5

Theory of operation

with Max. Standard Deviation 8 mmHg. NIBP processing uses an oscillometric technique to provide needed measurements at selected intervals. This technique uses an inflatable sphygmomanometer cuff similar to those used by clinicians in routine measurements. A motorized pump inflates the cuff to approximately 170 mmHg (adult mode) initially, at which point the pressure effectively stops the flow of blood. Then, under monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer detects the pressure and transmits the parameter signal to the NIBP input circuitry. As the pressure is reduced, blood flows in the previously occluded artery, and changes the measurements made by the transducer. The point at which oscillation increases sharply is defined as systolic pressure. As the cuff continues to deflate, the oscillation amplitude increases to a maximum, and then decreases. The peak oscillation amplitude is defined as the mean arterial pressure. The point at which the system detects a rapid decrease in oscillation is defined as the diastolic pressure.

4.2.11 SpO2 Processing SpO2 is a measurement of oxygen saturation in the blood that uses an optical spectrophotometry technique. It is based on the differences in the absorption of red and Infrared light by oxygenated and de-oxygenated Hemoglobin. A pulse oximeter passes red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle. The light sources are red and infrared light emitting diodes (LEDs). A photo diode provides detection. To identify the oxygen saturation of arterial hemoglobin, the G30/G40 Patient Monitors use the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular bed, and both blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The measurement is based on the difference between maximum and minimum absorption, focusing on the pulsatile arterial blood. In addition to the oximetry function, the measurement can also provide the heart rate.

4.2.12 ECG Processing The monitor measures the patient's ECG signals by sensing the varying potential difference between several points at the skin surface which respond to the electro-chemical actions of the muscular activity of the heart. Up to five electrodes are attached to the patient’s body. The varying potentials at these locations are sent to the ECG circuitry. These signals are amplified and filtered and then digitized before being transmitted to the microprocessor. The microprocessor executes algorithms to: • Calculate the ECG data 4-6

Theory of operation

• Compute the heart rate • Detect a lead-off condition if one of the electrode connections is disrupted • Detect the presence of pacemaker signals within the QRS waveform complex of the ECG • Generate an analog output for external use with defibrillators Note —

The ECG analog output is available at a connector

on the back of the monitor.

4.2.13 IBP Processing The invasive blood pressure (IBP) measurement produces real-time waveforms and numeric values for systolic, diastolic, and mean arterial blood pressure. IBP measurements use an A/D converter. An isolation transformer and opto-coupler provide the required isolation between isolated and grounded chapters of the monitor. Software algorithms filter typical artifacts like respiratory variation and pressure changes caused by flushing the line or drawing blood samples.

4.2.14 Temperature Processing Resistance temperature detectors (RTDs) measure temperatures using the physical principle of the positive temperature coefficient of electrical resistance of metals. The hotter they become, the larger – or higher –the value of their electrical resistance. The advantage is stable outputs for long periods of time, ease of recalibration, and accurate readings over relatively narrow temperature spans. The monitor’s input circuitry conditions and processes the signal to drive the numeric display.

4.2.15 etCO2 The etCO2 module contains a: • CO2 sensor assembly • Flow system, including pump • Signal processing PCB and peripherals • Serial interface • Power supply • FRS (FilterLine Recognition Safeguard) to identify correct usage of a MicroStream FilterLine® • Input gas connector with FRS interface The G30/G40 Patient Monitors use the Microstream® sidestream etCO2 method to measure carbon dioxide (CO2). The sidestream measurement method samples the respiratory gas with a constant flow from the patient’s airway and analyzes it with a 4-7

Theory of operation

remote CO2 sensor built into the monitor. The CO2 measurement produces: • A CO2 waveform • An end tidal (etCO2) value: the CO2 value measured at the end of the expiration phase • An inspired minimum CO2 (InCO2) value: the smallest value measured during inspiration • An airway respiration rate (awRR): the number of breaths per minute, calculated from the CO2 waveform All infrared gas measuring instruments, including the CO2 module, consist of a radiation source, a cell through which samples of gas flow and a detector that transmits a signal related to the intensity of the radiation that is detected. The quantitative aspects of photometric measurement are stated by the Beer-Lambert law: A = Log (Io/I) = εlc Under carefully controlled conditions at a select absorption band, the absorbency of a sample (A) is proportional both to the concentration of the sample (c) and the depth of the absorbing layer (l). The molar extinction coefficient (ε) is a wavelength dependent constant characterizing the sample. (Io) is the light intensity at zero absorbency and (I) is the light intensity after some of the light is absorbed by the sample. The CO2 module, as most continuous monitors of carbon dioxide, uses a non dispersive infrared (NDIR) light source. All CO2 monitoring instruments, except those manufactured by Oridion, that use a NDIR infrared light source, use the broad band energy from a black-body source. A mechanical chopper modulates the light beam and makes possible the monitoring of the sample, reference and dark signals from which the concentration of carbon dioxide can be determined. The CO2 module uses the energy generated by an infrared source that includes a proprietary gas filled lamp and driver circuit. This energy contains only specific wavelengths which match the absorption bands of the CO2. The CO2 module's infrared source is electronically modulated by the driver circuit.

4.2.16 Power Management The G30/G40 Patient Monitors contain a medical grade power supply module and circuitry that converts AC (100-240V) to DC (15V). Power consumption is 115 VA. The power management module contains: • Lead-acid batteries – 12 V, 2.3 AH • Battery charger 4-8

Theory of operation

• DC/DC converter The power management circuitry charges the battery through a battery charger(s). Both the battery(s) and the AC/DC power module can power the system through several DC/DC converters that provide various voltage outputs required by various chips. Isolated transformers provide the power to the front ends floating area.

4.2.17 Nurse Call Contacts The nurse call alarm contacts are available through a 3.5mm, miniature insulated phone jack on the back of the unit. The alarm contacts close (open) for any alarm condition detected by the monitor. The alarm contacts are the three switching signals associated with a single pole, double throw relay. These are the: • Normally open contact (NO) • Common contact • Normally closed contact (NC) Contact Rating of: NO = 1A @ < 25Vac Common contact = 1A @ < 60Vdc Isolation of 1.5kV

4-9

Theory of operation

(Blank)

4-10

G40 System Disassembly

Chapter 5 G40 System Disassembly 5.1 Service tools ................................................................................................. 5-2 5.2 To remove batteries ...................................................................................... 5-2 5.3 To remove the AC power connector fuse...................................................... 5-3 5.4 To remove the recorder................................................................................. 5-3 5.5 To remove the front case assembly............................................................... 5-4 5.6 Front case disassembly procedure ................................................................ 5-6 5.7 Main frame disassembly procedure.............................................................. 5-8 5.8 Rear case disassembly procedure ............................................................... 5-17

5-1

G40 System Disassembly

5.1 Service tools Only standard tools are required to perform service on this product. Following tools are recommended: ·One Cross-head screw driver Φ5mm (at least 100mm long) ·One Cross-head screw driver Φ3mm ·One Flat-Head screw driver Φ5mm ·One Wire cutter ·One Long flat nose plier ·One Hexagon Nut driver Φ5.5mm

5.2 To remove batteries Caution

Before removing the battery, perform a monitor shutdown and remove from AC power. To remove the batteries: 1. Push the battery cover, the pushing direction masked on the cover.

2. One thumb pushing the batteries and the other rotating the battery holder, to let the batteries out.

5-2

G40 System Disassembly

5.3 To remove the AC power connector fuse To remove a fuse in AC power connector: 1. Use a flat-head screwdriver to lift the fuse holder away from AC power connector.

2. Replace the fuse as the showing. Then push the fuse holder back into the power connector until it snaps into place.

5.4 To remove the recorder To remove the recorder: 1. Push up the plastic piece to open the recorder door. 5-3

G40 System Disassembly

2. Remove the two M3×6 screws holding the recorder to the monitor case.

3. Place your two thumbs on either side of the recorder case and pull it straight out of the assembly and remove the recorder connector cable.

5.5 To remove the front case assembly To remove the front case: 1. Turn the monitor over; remove five M4×8 screws in the button case.

5-4

G40 System Disassembly

2. Remove two M4×12 screws, then turn the monitor upright, the front case and the rear case are held by the buckle, gently open the monitor.

5-5

G40 System Disassembly

5.6 Front case disassembly procedure To remove ARM Module, Inverter and Display

To remove ARM Module: Remove the six M3×6 screws and the connector cables. Then remove the ARM Module.

To remove the Display assembly: Remove the seven M3×8 screws. Then remove the LCD gently.

5-6

G40 System Disassembly

To remove the inverter: 1. Remove the two M3×6 screws to remove the inverter shield.

2. Pull out the inverter control cable.

5-7

G40 System Disassembly

3. Pull out the two LCD driver cables

4. Remove the two M3 nuts by hexagon nut driver Φ5.5mm, and then remove the inverter.

5.7 Main frame disassembly procedure To remove the SpO2 module: 1. Remove the two M3×6 screws and the connector cable.

2. Pull up the SpO2 module gently.

5-8

G40 System Disassembly

To remove the IBP/Temp Module: 1. Remove the four M3×6 screws and the TEMP/IBP connector.

2. Pull up the IBP/ TEMP module gently.

To remove the main board module: 1. Remove the seven M3×6 screws and the power cable inverter cable, fan and speaker cable, recorder cable, ECG, NIBP, CO2 cables.

2. Remove the Main Board Assembly gently.

5-9

G40 System Disassembly

To remove the main frame from the rear frame: 1. Remove the five M3×6 screws then pull the main frame out gently.

5-10

G40 System Disassembly

To remove the ECG module: 1. Remove the three M3×6 screws and two connector cables.

2. Remove the ECG module gently.

5-11

G40 System Disassembly

To remove the CO2 module: 1. Remove the four M3×6 screws and the two cables.

2. Remove the CO2 tube and socket.

3. Remove the CO2 module gently.

Note —

See the To install the CO2 socket.

5-12

G40 System Disassembly

To install the CO2 socket: 1. Install the tube to the outlet.

2. Install the fixed socket.

3. Set the socket into the connector panel, and rotate it as showing direction 90°.

5-13

G40 System Disassembly

4. Install the screws.

To remove the NIBP module: 1. Remove the four M3×6 screws.

2. Remove the connector cables carefully, and then remove the NIBP module gently.

5-14

G40 System Disassembly

To remove the AC/DC power module: 1. Remove the four M3×6 screws.

2. Remove the power module gently.

To remove the Battery board: 1. Remove the four M3×6 screws.

2. Remove the battery board gently.

5-15

G40 System Disassembly

To remove the AC power connector: 1. Remove the two M3×6 screws.

2. Unplug the cable, cut the cable tie, and remove the yellow-green wire.

3. Remove the AC power connector gently.

To remove the I/O module: 1. Unplug the cables; remove the three M3×6 screws.

2. Remove the module gently. 5-16

G40 System Disassembly

5.8 Rear case disassembly procedure To remove the fan and the speaker assembly: 1. Remove the M3×6 screw and cut the black fixed tie.

2. Remove the fan’s screws, remove the fan gently.

5-17

G40 System Disassembly

3. Remove the speaker’s M3×6 screws then remove the speaker gently.

5-18

G30 System Disassembly

Chapter 6 G30 System Disassembly 6.1 To remove battery......................................................................................... 6-2  6.2 To remove the AC power connector fuse...................................................... 6-3  6.3 To remove the recorder................................................................................. 6-3  6.4 To remove the front case assembly............................................................... 6-4  6.5 Front case disassembly procedure ................................................................ 6-5  6.6 The main frame disassembly procedure ....................................................... 6-7  6.7 The rear case disassembly procedure ......................................................... 6-15 

6-1

G30 System Disassembly

6.1 To remove battery Caution

Before removing the battery, perform a monitor shutdown. To remove the battery: 1. Push up the battery cover as showing below.

2. Rotate the battery holder to let the battery out.

6-2

G30 System Disassembly

6.2 To remove the AC power connector fuse To remove a fuse in AC power connector: 1. Use a flat-head screwdriver to lift the fuse holder away from AC power connector.

2. Replace the fuse, remove the fuse as shown. Then push the fuse holder back into the power connector until it snaps into place.

6.3 To remove the recorder To remove the recorder: 1. Push up the plastic piece to open the recorder door.

6-3

G30 System Disassembly

2. Remove the two M3×6 screws holding the recorder to the monitor case.

3. Place your two thumbs on either side of the recorder case and pull it straight out assembly and remove the recorder connector cable gently.

6.4 To remove the front case assembly To remove the front case: 1. Turn the monitor over; remove the two M4×8 screws in the rear case as showing.

2. Remove the two M4×8 screws, then turn the monitor upright, the front case and the rear case are held by the buckle, gently open the monitor, and disconnect the

6-4

G30 System Disassembly

cables as shown.

6.5 Front case disassembly procedure This section describes how to remove items in the front case. To remove ARM module: 1. Remove the six M3×6 screws and the connector cables.

6-5

G30 System Disassembly

To remove the display assembly: 1. Remove the six M3×8 screws. Then remove the display assembly gently.

To remove the inverter: 1. Remove the two M3×6 screws to remove the inverter shield.

2. Pull out the inverter control cable and the LCD driver cable.

6-6

G30 System Disassembly

3. Remove the two M2×4 screws, and then remove the inverter.

6.6 The main frame disassembly procedure This section describes how to remove items in the main frame.

To remove the main frame from the rear case: 1. Remove the four M3×6 screws and remove the Speaker cable, Fan cable and the SpO2 cable.

2. Turn the monitor over, remove the three M4×6 screws, and then pull the main frame out gently.

6-7

G30 System Disassembly

To remove the Connector panel: 1. Remove the IBP/TEMP cables and the SpO2 cable

2. Remove the ECG cable and NIBP tube.

6-8

G30 System Disassembly

3. Remove the CO2 tube and socket.

Note —

See the To install the CO2 socket.

To remove the SpO2 module: 1. Remove the two M3×6 screws and the connector cable.

2. Pull up the SpO2 module gently.

6-9

G30 System Disassembly

To install the CO2 socket: 1. Install the tube to the outlet.

2. Install the fixed socket.

3. Set the socket into the connector panel, and rotate it as showing direction 90°.

4. Install the screws.

6-10

G30 System Disassembly

To remove the IBP/TEMP module: 1. Remove the four M3×6 screws and the IBP/TEMP connector.

2. Pull up the IBP/TEMP module gently.

6-11

G30 System Disassembly

To remove the ECG module: 1. Remove the three M3×6 screws and the ECG cable connected with System module.

2. Remove the ECG module gently.

To remove the CO2 module: 1. Remove the four M3×6 screws.

2. Remove the CO2 module gently.

To remove the NIBP module: 1. Remove the four M3×6 screws and the cable connected with the Main Board.

6-12

G30 System Disassembly

2. Remove the NIBP module gently.

To remove the Main Board assembly: 1. Remove the seven M3×6 screws, the power cable, inverter cable, fan and speaker cable, recorder cable, ECG, NIBP, CO2 cable.

2. Remove the Main Board module gently.

To remove the AC/DC power module: 1. Remove the four M3×6 screws.

2. Remove the power module assembly gently.

6-13

G30 System Disassembly

To remove the Battery Board: 1. Remove the four M3×6 screws.

2. Remove the Battery Board gently.

To remove the AC power assembly: 1. Remove the cable. 2. Remove the two M3×6 screws.

3. Remove the AC power assembly gently.

6-14

G30 System Disassembly

To remove the I/O module assembly: 1. Unplug the cables, remove the three M3×6 screws.

2. Remove the I/O module assembly gently.

6.7 The rear case disassembly procedure To remove the fan and the speaker assembly: 1. Remove the M3×6 screw and the four screws.

6-15

G30 System Disassembly

6-16

Drawing Document

Chapter 7 Assembly Diagrams and Service Parts

7.1 G40 main assembly exploded diagram...................................................................7-2 7.2 G40 Front Case assembly and parts .......................................................................7-4 7.3 G40 rear case assembly and parts...........................................................................7-6 7.4 G40 main frame assembly and parts.......................................................................7-7 7.5 G30 main assembly exploded diagram.................................................................7-10 7.6 G30 front case assembly and parts .......................................................................7-12 7.7 G30 rear case assembly and parts.........................................................................7-14 7.8 G30 main frame assembly and parts.....................................................................7-15

7-1

Drawing Document

7.1 G40 main assembly exploded diagram Figure 7-1 G40 main assembly exploded diagram

1

2-M4X8 5-M3X6 2 3 4

3-M4X8 2-M4X12

5

2-M3X6 7-2

Drawing Document

Table 7-1 G40 main assembly exploded diagram list Reference Number

1 2

3 4 5

Description

Front case Main frame Connectors panel (standard+IBP+CO2) Connectors panel (standard + IBP) Connectors panel (standard + CO2) Connectors panel (standard) Rear case Recorder

7-3

Part Number

NA NA 83801021000 83801022000 83801023000 83801024000 NA 83801015000

Drawing Document

7.2 G40 Front Case assembly and parts Figure 7-2 G40 front case assembly exploded diagram 2-M3X6 6-M3X6 1

2

Nut2-M3

3

7-M3X8 4

5

7-4

Drawing Document

Table 7-2 G40 front case assembly parts list Reference Number

1 2 3 4 5

Description

Inverter TPI-02-0426-K ARM Module Front case and display assembly Display assembly G40 Front case assembly G40

Part Number

G40

7-5

83801016000 83801007000 83801020000 83801019000 83801018000

Drawing Document

7.3 G40 rear case assembly and parts Figure 7-3 G40 rear case assembly exploded diagram 2-M3X6 2-M3X6

1 2 M3X6

3

Table 7-3 G40 rear case assembly parts list Reference Number

1 2 3

Description

Part Number

Speaker assembly Fan Rear case assembly G40

83801014000 83801013000 83801017000

7-6

Drawing Document

7.4 G40 main frame assembly and parts Figure 7-4 G40 main frame assembly exploded diagram, view 1

1 2-M3X5 2

4-M3X5 3

7-M3X6

Table 7-4 G40 main frame assembly parts Reference Description Number 1 SpO2 Module 2 IBP/Temp Module 3 Main Board assembly G30/G40

7-7

Part Number 83801002000 83801003000 83801001000

Drawing Document

Figure 7-5 G40 main frame assembly exploded diagram, view 2

1 2-M3X6

2

3

5

3-M3X6 11-M3X6

Table 7-5 G40 main frame assembly parts Reference Number 1 2 3 4 5

Description AC power assembly G40 ECG Module NIBP Module CO2 module I/O module assembly G30/G40

Part Number 83801011000 83801005000 83801006000 83801009000 83801010000

7-8

Drawing Document

Figure 7-6 G40 main frame assembly exploded diagram, view 3

4-M3X8 1

2

4-M3X8

Table 7-6 G40 main frame assembly parts Reference Description Number 1 AC/DC power module 2 Battery Board

7-9

Part Number 83801008000 83801012000

Drawing Document

7.5 G30 main assembly exploded diagram Figure 7-7 G30 main assembly exploded diagram

1 5-M3X6 2 3

3-M4X8 5 4

4-M4X8

2-M3X6 7-10

Drawing Document

Table 7-7 G30 main assembly exploded diagram list Reference Number

1 2 3

4 5

Description

Front case Main frame Connectors panel（standard +IBP+CO2） Connectors panel（standard +IBP） Connectors panel（standard +CO2） Connectors panel（standard） Rear case Recorder

7-11

Part Number

NA NA 83801021000 83801022000 83801023000 83801024000 NA 83801015000

Drawing Document

7.6 G30 front case assembly and parts Figure 7-8 G30 front case assembly exploded diagram 6-M3X6 2 2-M3X6

1

2-M3X6

3

4

5

7-12

Drawing Document

Table 7-8 G30 front case assembly parts list Reference Number 1 2 3 4 5

Description

Front case and display assembly ARM Module Inverter BSFI#1011-44B Display assembly G30 Front case assembly G30

Part Number

G30

7-13

83801031000 83801007000 83801027000 83801030000 83801029000

Drawing Document

7.7 G30 rear case assembly and parts Figure 7-9 G30 rear case assembly exploded diagram 2-M3X6

2-M3X6

1 2

M3X6

3

Table 7-9 G30 rear case assembly parts list Reference Number 1 2 3

Description

Part Number

Speaker assembly Fan Rear case assembly G30

83801014000 83801013000 83801028000 7-14

Drawing Document

7.8 G30 main frame assembly and parts Figure 7-10 G30 main frame assembly exploded diagram view 1

1 2

2-M3X6

4-M3X6

3

7-M3X6

Table 7-10 G30 main frame assembly parts Reference Description Part Number Number 1 SPO2 Module 83801002000 2 IBP/ Temp Module 83801003000 3 Main Board assembly G30/G40 83801001000

7-15

Drawing Document

Figure 7-11 G30 main frame assembly exploded diagram, view 2

1 2

3

5 5-M3X6 11-M3X6

4

Table 7-11 G30 main frame assembly parts Reference Number 1 2 3 4 5

Description I/O module assembly G30/G40 ECG Module NIBP Module CO2 module AC power assembly G30

Part Number 83801010000 83801005000 83801006000 83801009000 83801025000

7-16

Drawing Document

Figure 7-12 G30 main frame assembly exploded diagram, view 3

1

2

Table 7-12 G30 main frame assembly parts Reference Description Number 1 AC/DC power module 2 Battery Board G30

7-17

Part Number 83801008000 83801026000

Drawing Document

(Blank)

7-18

Appendix A Electromagnetic Compatibility A.1 Instructions for use .................................................................................A-2  A.2 Guidance and Manufacturer's EMC Declaration....................................A-3  A.2.1 Electromagnetic Emissions for all Equipment and Systems ...............A-3 A.2.2 Electromagnetic Immunity for all Equipment and Systems ................A-3 A.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting .............................................................................................A-5  A.2.4 Recommended Separation Distances ..................................................A-6 

A-1

A.1 Instructions for use Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC60601-1-2:2004, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1- 2:2004. Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product. Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your service provider for assistance with the minimum recommended separation distance between RF communications equipment and the product. The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in this manual. Warning

Use of accessories, transducers, and cables other than those specified may result in increased emissions and/or decreased immunity of the G30/G40 Patient monitors. G30/G40 Patient monitors should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor should be observed to verify normal operation in the configuration in which it is used.

Caution

The following ports on G30/G40 Patient monitors are sensitive to electrostatic discharge during patient monitoring: • SpO2 • ECG Follow these guidelines to reduce electrostatic discharge: • Do not touch the connector pins of the port. • When connecting and disconnecting cables to the ports, use ESD precautionary measures. Precautionary measures may include the following: – Make sure you are grounded prior to connection. Touch grounded metal. – Wear an ESD grounding strap and an ESD protective garment.

–

Provide ESD training to all users. Users should understand what electrostatic discharge is, how damage can occur, and how to prevent ESD.

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A.2 Guidance and Manufacturer's EMC Declaration The G30/G40 Patient Monitors are intended for use in the electromagnetic environment specified below. The customer or the user of the G30/G40 Patient Monitors should assure that it is used in such an environment.

A.2.1 Electromagnetic Emissions for all Equipment and Systems Table A-1 Electromagnetic emissions-for all EQUIPMENT and SYSTEMS Emission test RF emissions CISPR 11

Compliance

Electromagnetic environment – guidance

Group 1

The G30/G40 Patient Monitors use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

The G30/G40 Patient Monitors are suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

A.2.2 Electromagnetic Immunity for all Equipment and Systems Table A-2 Electromagnetic immunity –for all Equipment and Systems IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines

±1kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment. It recommends the use of filters on power input lines.

Immunity test

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Immunity test Surge IEC 61000-4-5

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

±1 kV Differential mode

±1 kV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

±2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60Hz) magnetic field IEC61000-4-8

±2 kV common mode

95% dip in UT) for 0.5 cycle

95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT)for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

95% dip in UT) for 5 sec

95% dip in UT) for 5 sec

3A/m

3A/m

Mains power quality should be that of a typical commercial or hospital environment. If the user of the G30/G40 Patient Monitors requires continued operation during power mains interruptions. It is recommended that the G30/G40 Patient Monitors be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields Should be at levels characteristic of a typical location in a typical commercial or hospital environment.

1. UT is the AC mains voltage prior to application of the test level.

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A.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting Table A-3 Electromagnetic immunity –for Equipment and Systems not Life-Supporting Immunity test

IEC60601 test level

Compliance level

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the G30/G40 Patient Monitors, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ V1 ⎦

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ E1 ⎦ ⎡7⎤ d =⎢ ⎥ P ⎣ E1 ⎦ Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

1. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field A-5

strength in the location in which the G30/G40 Patient Monitors are used exceeds the applicable RF compliance level above, the G30/G40 Patient Monitors should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the G30/G40 Patient Monitors. 2. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

A.2.4 Recommended Separation Distances The G30/G40 Patient Monitors are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the G30/G40 Patient Monitors can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the G30/G40 Patient Monitors as recommended below, according to the maximum output power of the communications equipment. Table A-4 Recommended separation distances between portable and mobile RF communications equipment and G30/G40 Patient Monitors Separation distance according to frequency of transmitter(m)1 Rated maximum

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

output power of

(W)

⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ V1 ⎦

⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ E1 ⎦

⎡7⎤ d =⎢ ⎥ P ⎣ E1 ⎦

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

transmitter

1. For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note —

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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The following interference test results do not affect patient diagnoses.

Immunity test

Electrical fast transient/burst IEC 61000-4-4

Table A-5 Interference phenomena IEC 60601 test level Compliance level Phenomena

±2 kV for power Supply lines

1kV for power supply lines

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Adding ±2KV interference to the power supply line heavily interfered with the ECG waveform. Decreasing interference to ±1KV slightly interfered with the waveform. Removing the interference returned the waveform to the previous operating mode within 10 seconds with no loss of stored data.

(Blank)

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