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Noa III Infusion System

SERVICE MANUAL

0344 Manufacturer: Caesarea Medical Electronics GmbH 23 Staufenburg st. 72805 Lichtenstein, Germany International Toll Free: +800-323-575-00 Contact e-mail: [email protected] www.cme-infusion.com

EDITION 2 November 2009

Ref.: 100-092XN

The Noa III Infusion Pump

2

Table of Contents Introduction ……………………………………………………………………………. Glossary ……………………………………………………………………………………. Specifications ………………………………………………………………………..……. Noa III Front view ……………………………………………………………………. Noa III with Open Door ………………………………………………………….……. The Charger ………………………………………………………………………….……. Safety Precautions …………………………………………………………………………. Alarm Conditions……………………………………………………………………..……. Troubleshooting ……………………………………………………………………..……. Info Mode …………………………………………………………………………………. Stopping Pump Operation …………………………………………………………………. Changing Fluid Container …………………………………………………………………. Setting “Down Occlusion” ………………………………………………………..….……. Locking ……………………………………………………………………………..……. How to Lock ………………………………………………………………………………. “Show Setting” ……………………………………………………………………………. “Adjust Setting” ……………………………………………………………………..……. “Technician Mode” ………………………………………………………………………… Automatic calibration ……………………………………………………………………… Volume calibration ………………………………………………………………………… Automatic pressure calibration ……………………………………………………….……. Pressure Setting ………………………………………………………..…………………… Changing Current Program ………………………………………………………………… Unpacking …………………………………………………………………………..……… Loading the Administration Set ……………………………………………………………. IV set Requirements – NoaSet ……………………………………………………….…… NoaValve …………………………………………………………………………..……. Priming Function. ……………………………………………………………….…….. .. Noa III Operating ………………………………………………………………..……. Pump Operation Test. ………………………………………………………….…………. Air in Line Alarm Test. ……………………………………………………………..……. Door Open Alarm Test. ……………………………………………………………..……. Down Occlusion Alarm Test. ……………………………………………………………. Charge Indicator Test. ……………………………………………………………………. Basic Operation …………………………………………………………………..….……. Hospital Service Procedures ………………………………………………………………. Replacement of power fuses ………………………………………………………………. Battery Protection fuse….. ………………………………………………………………. Fuse Nominal (charger) ………………………………………………………………….. Preventing Maintenance ………………………………………………………………….. Cleaning and Storage ………………………………………………………………………. Battery Operation. …………………………………………………………………………. Testing Procedures …………………………………………………………………………. Maintenance Flow Chart …………………………………………………………………. Service Information ………………………………………………………………………. Failure Identification ………………………………………………………………………. Corrective actions ………………………………………………………………………. Operational Checkout ……………………………………………………………………. Limited Warranty …………………………………………………………………………. Appendixes : A. Electronic Drawing B. Mechanical Drawing C. Pump – testing form

3

4 5 6-7 8-9 10 11 12-13 14 15-17 18 19 20 21 22 23-24 25-26 27-28 29 30 30 31 31 32-33 34 34 35 36 37 38 38 39 40 41 41 42-44 45 45 45 46 47-49 50 51 52 53 54 54 55-60 61-63 64

Introduction This Manual Provides directions for setup and operation of the Noa III Pump

Noa III Features The NOA III enteral pump is intended to control application of enteral nutrition. The pump can be used for mobile patient with an integrated rechargeable battery, or stationary with connection to main by a charger. This Manual Provides directions for setup and operation of the NOA III Pump 

Small, light and compact pump.



Multi Programs:

RATE

Rate Program Infusion Rate: 1 to 500 ml/hr.

RATE/VOLUME

Rate Over Volume Program Infusion Rate: 1 to 500 ml/hr. Volume: 1 to 9999 ml.

BOLUS

25 STEPS

Bolus Program A set Dose delivered in set intervals. Between Intervals the pump will keep the tube open (KTO). User can design a specific protocol, for drug Delivery, which contains up to 25 steps. Infusion Rate: 1 to 500 ml/hr. Volume: 9999ml., For each step. Accumulated Volume for all steps – up to 10 liters.



Highly accurate fluid delivery. The piston mechanism ensures accurate volume delivery over more than 24 hours using the same administration set segment



Operated with a customized safe administration set (optional)



Rechargeable internal battery



Can be clicked into a Charger, which is mounted on an IV pole



Charger enables monitoring operation via telephone line (optional)



Anti-free flow protection valve on the administration set (Optional)



Silent operation 4

Glossary Terms used in manual: 

Note:

Essential operating procedure or condition.



Caution:

A precaution which, if not followed, could result in extensive damage to the equipment.



Warning

A precaution, which, if not followed, can result in personal injury or loss of life.

5

Specifications Pumping Mechanism:

Piston Mechanism

Flow Rate:

1 to 500 ml/hr in 1ml increments

Total Infused Volume:

1 to 10,000 ml.

Total Time Setting

100 hours

Accuracy:

± 5%.

KTO rate:

1 to 5 ml/hr. (to be set)

Air Sensor:

Ultrasonic, adjustable air bubble size

Maximum Pressure:

15 psi Adjustable (high/normal/low)

Power Supply:

110-240 VAC, 50/60 Hz.

Battery:

Li-Ion 7.2V, 1450 mA. (Rechargeable)

0.12A

Battery Operation at 125 ml/hr 15 hours Battery Charging:

Automatic when clicked into the Charger connected to an AC power source (4 hours)

Language:

English or German

Alarms:

Mechanical Error Low & End Battery Pump Unattended Air in line Down Occlusion Door Open Program End Locking state

Acoustic buzzer level:

Low to high – adjustable.

Dimensions:

112 x 89 x 32mm. (L x w x h).

Symbol

Attention (Consult accompanying documents)

Surrounding

Min. +150C Max. 350C. Humidity 85%.

6

Specifications Classification

Housing:

Type CF Equipment (degree of protection against electrical shock) Class IIb device (according to 93/42/EEC Medical devices directive) ABS (fire retardant)

Weight

280 gr.

Electrical Safety

Complies with: IEC 601-1 (Medical Electrical Equipment Safety), IEC601-2-24 (Infusion pumps and controllers), IEC 601-1-4 (Programmable Electrical Medical System), UL 2601- 1 and CAN/CSA C22.2 No 601.1.

Standards

Manufacture in accordance to ISO 9001 and

(without battery)

EN 46001 CE marked (In accordance with the Medical

Devices Directive 93/42/EEC) Special Information:

Service reminder after 5000 hours. Call off the last 256 events. Nurse call with wire or wireless – LPS (optional)

7

Noa III Front View

1 2

5

3 4 7

9

5

6

10 8

No. 1.

Description Display

Function Displays: Selected Infusion Rate, Total Time, Volume To Be Infused and Volume Infused.

Rate 125 ml /h Press OK for Volume 2.

Arrow keys

Increases / Decreases the infusion RATE, TIME limit and VTBI. Press the arrows keys consecutively for individual unit changing. Press the arrow keys continuously for sustain unit changing.

8

3.

Syringe key

Pressing Syringe key automatically primes administration set. Priming volume: 20 ml. PRIME

10 ml

0

20

4.

Info key

Pressing Info key supplies information about the pump and its programs.

5.

START/ OK Key

Starts pump operation and delivery. Confirms selection and setting.

6.

STOP/NO key

7

On/Off key

8.

Operation Led

 Silences an alarm condition and pauses priming.  Zeroes the displayed value during setting  Press twice to return to previous screen Turn the pump on and off.  To turn the pump on press until the self-test screen appears  To turn the pump off press until the OFF graph is all black and a beep is sounded. Flashing of the Led in green indicates that the  set program is running. Red light indicates that the pump stopped.

9.

Door Latch

Opens the pump door. Lift to open the door.

9

Noa III–with open door

1

2 6

3 4

7 5

No.

Description

Function

1.

Latch holder

Holds the door closed when latch is in vertical position.

2.

Pressure sensor

Detects downstream tubing restriction and occlusion. Alarm level can be adjusted to suit patient needs.

3.

Tubing Guide

Guide the administration set

4. 5. 6.

Pressing Plate Pump door Air sensor – front

7

Air sensor - door

Connected to the door by 2 springs. Covers the pressing plate. Ultrasonic air detector, which is mounted on the front housing. Mounted on the door. 10

The Charger

1 Noa III with drop sensor No. Description 1.

Release Handle

2

Function

Push to release the pump from the Charger.

11

Safety Precautions 

!

Warning

To avoid possible personal injury or loss of life, observe the following:  Note: Read the entire Operation Manual before using the pump, since the text includes important precautions. 

Disconnect the Charger from the mains, prior to opening the casing. Voltage present on internal components may cause severe shock or death on contact. Only trained service personnel should open the pump cover.



Before servicing pumps connected to mains via the Charger - remove rings, watches, and other jewelry, which may present a shock / burn hazard.



To prevent a fire hazard, replace blown fuses on the Charger only with fuses of the same type and rating (see fuse values on the Charger PCB).



The equipment is not suitable for use in the presence of flammable anaesthetic-air/ oxygen/nitrous oxide mixture.



Watch your fingers / nails when opening the pump door.

To avoid possible injury to patient, observe the following:  Warning Battery charging is enabled as long as the charger cord is connected to the mains and the pump is in the charger. Switching the pump off doesn’t disconnect it from the mains. In order to disconnect from the mains, take the charger cable out of the mains. In order to disconnect pump from the mains, take it out of the charger. 

Note:

To avoid battery damage do not leave the pump battery in a temperature more than 500C



Make sure the pump is attached securely to the Charger, which is connected snugly to an IV pole.



If the pump is dropped, return the pump for inspection by qualified service personnel.



Before operation, verify that administration set tubing is not kinked or 12

occluded. 

This pump should be operated only with the NoaSet. Use of administration sets other than the NoaSet may impair the operation of the pump and the accuracy of the infusion.

Warning: The NoaSet is not suitable to use with Taxol. 

Note:

The maximum volume that may be infused under SINGLE FAULT CONDITION is 0.1 ml

 CAUTION To avoid possible damage to the equipment, observe the following: 

Do not immerse the pump in liquids.



Clean solution spills on the pump immediately. Use a damp cloth or sponge. A cleaning disinfectant may be used. Wipe thoroughly with a dry cloth.



Do not clean pump with chemicals such as Xylene, Acetone or similar solvents. These chemicals cause damage to plastic components and paint.

Warning: Any adjustments, maintenance, or repair of the uncovered pump while connected to the power should be avoided. If necessary, these repairs should be carried out by skilled technicians who are aware of the hazards involved. Warning: The pump should be operated within a temperature range of 15C to 35C. and at up to 85% humidity Warning: Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterizing equipment, and cellular telephones. False alarm signals may occur.

13

Alarms Conditions At any time, when the pump detects a problem, an alarm is activated and the following will occur:  An alarm message appears on the display, stating the cause of the alarm and indicates instructions for continued use.  An audible alarm sounds.  The infusion stops.

Alarms  Air in Line  Door Open  Down Occlusion  Pump Unattended  Low Battery  End Battery  Internal Malfunction  End Program  Missing Key The “Troubleshooting Table” (on the next pages) describes the pump’s alarm conditions and remedies.

14

Troubleshooting Description Air in Line

Air in Line

Result Infusion ceases

Possible Cause Air is present in administration set

Clean air

The roller clamp above the pump is closed.

Door Open

Door Open

Infusion ceases

Pump Unattended

The door of the pump was Close Door not closed prior to operation

Infusion ceases

Roller clamp closed Open the Roller clamp Set kinked Straight out the set Administration set loaded Reload administration incorrectly set, as described on page 21 Cannula blocked Change Cannula **User may change Adjust pressure setting, pressure setting as described on page 31

Pump operation has been stopped

No key was pressed for 2 Press the START/OK key minutes.

Press STOP to mute

No key has been pressed for 2 minutes, during setting

Disconnect patient, press the STOP/NO key and remove the air from Administration set, as described on page 23. After flushing, press the START/OK key to resume the program. Open Roler clamp

The door has accidentally opened during operation.

Close door

Down stream occlusion causing pressure on Downhigh Occlusion pressure sensor

Remedy

Press start key

15

Troubleshooting Description Message displayed showing  30 minutes left of battery operation

Low Battery

Result

Possible Cause

Remedy

If pump Message will be displayed as Connect to Mains won’t be connected long as the internal battery voltage is less than 7.1v. to mains, battery will be depleted

Connect to charger End Battery

End Battery

Infusion ceases

Connect to Mains and Battery is depleted. The pump cannot be used wait 2 minutes before before being connected to operating. mains.

Program parameters can not be changed

The program is set in No action required. second-level locking, which enables daily operation of the set program, without the ability to change parameters.

Infusion ceases

The pump will advise the user to send the pump for service. See list of error at the end of this chart.

Connect to charger Pump is in lock-mode

Lock out A fatal error is detected

Error XXX Send for Service Program completed

End PROGRAM

Pump will The program was completed Press the STOP/NO turn to key to restart KTO mode

Press STOP to mute

KTO

5 ml/h

Press STOP to renew

Restart the pump. If the alarm does not stop pack the pump properly, in its original packaging, and send it for service.

KVO (Keep Vein Open) program starts.

16

Error code 10 11 12 13 15 16 17 18 19 20 21 23 24 25 29 30 31 32 34 40 52 72

Error Description Motor did not move for more than 120 seconds. Pump can not operate at requested rate Error on encoder channel 3 Encoder rotation time error. Stack overflow External timer communication error Internal eeprom error Thermometer communication error Watch dog 2 failed test. Rotating encoder channel 1error. Rotating encoder channel 2 error. Timer error. Time comparison error. AC power error. Key pressed during power up test. Error data reading from external memory – double check. Error data reading from external memory – full check sum. Processor hardware reset. ADC error. Check sum error – data or processor. 60-minutes event in pumping mode Antibolus reverse rotation

17

Info Mode The info Mode is divided into two groups. a. The info key is pressed during operation. b. The info key is pressed during data setting or stop.

info during operation Display the total Volume To Be Infused and the Infused Volume by pressing the info key once during operation. The screen will be displayed for 10 seconds.

VI

1

Press the info key twice to display battery status.The screen will be displayed for 10 seconds.

ml

VTBI

715

1111

Battery Level Empty

Press the info key 3 times to display IV nutrition set temperature. The screen will be displayed for 10 seconds.

Full

Temperature

o

+ 28 C

info during setting or STOP VI Display the total Volume To Be Infused and the Infused Volume by pressing the info key once The screen will be displayed for 10 seconds. 1



Note:

ml

VTBI

715

1111

 INFUSED Volume will automatically reset to zero when pump is switched OFF.

18

STOPING PUMP OPERATION Press the STOP/NO key to stop the pump. This ceases pump operation and the display showes STOP: Stop mode is limited to 5 min. After 5 min. an audiable alarm is sounded. Press STOP/NO key again, to mute the alarm.

STOP 2 min Press OK to start

Pump Unattended Press start key

From STOP switch the pump off by pressing the ON/OFF key (continuously until the OFF graph is all black and a beep is sounded). 

Note:

OFF

The pump cannot be switched off during operation.

19

Changing The Fluid Container Important: Use the technique dictated by the homecare provider 1. Ensure that pump is not infusing by placing pump in STOP mode or turning pump OFF. 2. Remove empty bag / used container. Discard empty/used bag/container according to manufacturer instructions. 3. Prepare new container as per homecare provider instructions and insert spike into new container. 4. Squeeze drip chamber (if applicable) to fill approximately halfway with fluid. 5. Restart infusion.

20

Down Occlusion Setting: 1.

Switch the pump on, by pressing ON/OFF key ON OFF

2. When the screen of Rate appears, press info key twice. 3. Use ARROW keys (2↑, 0↓) to scroll to "Adjust Setting" option.

Volume Infused Show Setting

=> Adjust Setting 4. Choose "Adjust Setting" with START/ OK key. 5. The option selected is “pressure level”.

Adjust setting:

=> Pressure Level Buzzer Level

6. Confirm with START/OK key. 7. Choose the desired pressure level, using the arrow keys (2↑, 0↓).

Pressure setting

High

10 psi

Adjust ↑↓ & press OK

8. Press the START/OK key to store the parameter in the pump’s memory. 

Note:

The following pressure parameters can be set: Low

= 7 psi

Normal = 14 psi High 

Note:

= 21 psi

The selected pressure setting will remain in the pump’s memory only until turning off (and then return to the default).

21

Locking The Noa III enables the user to lock the programs, on three different levels. Level 1 (keys locking) Level 2 (lock out program) Level 3 (presetting maximal rates) Level 1 – key locking The Noa III keys locking function disables all but the info key, START/OK (during setting mode) and STOP/NO (during operation mode) keys. Level 2 – program locking The Noa III has a unique option, which enables the user to lock out the numeric keys, so that entered parameters, or set programs cannot be changed once they are set. This option is important, for example, when children are users, when there is a danger that the child might play with the pump and unknowingly change the program; or for home-care patients whom repeating the same program every day, it's important to have a lock-out program, to prevent mistakes in setting. Level 3 – maximal rate locking The Noa III provides the option of setting a maximal rate in the technician mode. The program rate can be adjusted up to a preset limit. For home patient (mainly for TPN or PCA treatments), who must repeat the same program daily, the option of adjusting the delivery regiment is very important.

22

How to Lock ? Level 1 – key locking Pressing continuously on the info key, untill the LOCK Mode graph is all black and a beep is sounded will lock the program. OFF

ON

A key will be shown on the right side of the display, indicating that the program is first level locked. Pressing continuously on the info key, untill the LOCK Mode graph is all empty and a beep is sounded will unlock the program. OFF

ON

Level 2 – program locking Press info key twice, from stop or setting mode. Use ARROW keys to scroll to "Adjust Setting" option.

Volume Infused Show Setting

=> Adjust Setting Choose "Adjust Setting" with START/OK key. Use ARROW keys to scroll to "More" and confirm with START/OK key.

Buzzer level

=> More … Show Setting

Set technician Code (Code 13), and confirm with START/OK key.

Technician

13

Code Use one of ARROW keys to change from OFF to ON. Confirm with START/OK key.

Lock Out

ON Adjust ↑↓ & press OK

The default setting is “Lock Out - NO”. Unlock in the same procedure.

23

Level 3 – maximal rate locking Set a maximal rates in the technician mode. 1

Press info key twice. Use ARROW keys to scroll to "Adjust Setting" option.

Volume Infused Show Setting

=> Adjust Setting 2

Choose "Adjust Setting" with OK/START key. Use ARROW keys to scroll to "More".

Buzzer level

=> More … Show Setting

3

Confirm with START/OK key.

4

Set technician Code (Code 21), using the ARROW keys and confirm with START/OK key.

5

Scroll through the setting parameters, using the ARROW keys, until the "Maximal Rate " option. Confirm with START/OK key.

Technician Code

2008

Bolus Times/hour

=> Maximal Rate KTO Rate

6

Set the maximal rate, using the ARROW keys and confirm with START/OK key.

Maximal Rate

500.0 ml/h Adjust ↑↓ & press OK



Note:

The default setting for maximal rate is 500 ml/h.



Note:

The selected Locking Option will remain in the pump’s memory until changed by user.

24

o.

Show Setting The program was designed to disable unauthourised user access to technician settings. Press info key twice. Choose "Show Setting" to display all software adjustable parameters. User may inspect all settings, but not change them. Scroll down the followung parameters on the Show Setting mode:

Volume Infused

=>Show Setting Adjust setting Show Setting:

=>Battery Level Lock Out

Show Setting Options Setting Battery Level (Empty ↔ Full) Lock Out Option (ON/OFF) Time & Date display Tube Temperature Buzzer Level Pressure level (High/Normal/Low) Pressure Default Selected Program Display priming volume (different than the 20 ml.default- up to 20 ml) Display BOLUS rate (different than default) Display no. of BOLUSES per Hour Maximal Rate setting Display KTO rate Air bubbles size Program Language Prime Test – future option Pump Serial Number Pump Production Date Operation Time (in full hours)

Screen Battery Level Lock Out Time, Date Tube Temperature Buzzer Level Pressure level Pressure Default Select Program Priming Volume Bolus Rate Bolus Times/hour Maximal Rate KTO Rate Air bubble Size Language Prime Test Option Serial Number Production Date Operation Time 25

o.

Setting Software Version Volumetric Calibration Pressure Calibration - Delta Pressure Calibration - Cap EXIT

Screen Software Version Volume Calibration Pressure Delta Pressure CAp EXIT

26

Adjust Setting Choose "Adjust Setting" to display all software adjustable parameters.

Volume Infused Show Setting

=>Adjust Setting Confirm with OK/START key. See list of parameters that can be set on "Adjust Setting" selection on the next page.

Adjust Setting:

=> Pressure Level Buzzer Level

The first 2 parameters, Pressure level and Buzzer level, can be adjusted using the arrow keys. Access to “More…” will required a code. Use ARROW keys to scroll to "More".

Buzzer level

=> More … Show Setting

Confirm with START/OK key. Set technician Code (Code 21), using the ARROW keys and confirm with START/OK key.

Technician Code

2008

** For program locking (lock level 2) – set code 13 Scroll through the setting parameters, using the ARROW keys and change them if necessary.

27

Adjust Setting Options Screen no. A B C D 1 2 3 4 5 6 7 8 9 10 11 12 13

Adjust Lock Out Option (use Code 13 ) Buzzer Level (use code 19) Pressure level (use code 19) More… Use code 2008 to enter Restart Pump Pressure Default Select Program Setting priming volume (up to 20 ml) Setting BOLUS rate (different than default) Settng no. of BOLUSES per Hour Maximal Rate setting Setting KTO rate Air bubble size Language Prime Test – future option Set Time & Date History

28

Screen Lock Out Buzzer Level Pressure level More… Restart Pump Pressure Default Select Program Priming Volume Bolus Rate Bolus Times/hour Maximal Rate KTO Rate Air bubble Size Language Prime Test Option Set Time & Date History

Technician Mode To acess the technician mode, press the info key continuouslly while switching the pump on (until “technitian code” screen is displayed). The display will show the software version for 2 seconds and than the technitian code screen. Use code #19150 to enter technitian mode. The pump will display all the parameters that can be set, calibrated or tested. The technician can scroll down all these parameters using the ARROWS keys. no. 1. 2.

Testing Input s/n and service date Display Volume & Pressure calibrations 3. Perform self test 4. Volumetric accuracy test 5. Functions tests 5.1 Keypad Test 5.2 Display 5.3 Buzzer 5.4 Door 5.5 Air Sensor 5.6 Temperature 5.7 Motor 5.8 5.9

Pressure Exit 6. Pressure Calibration 7. Volume Calibration

8. Factory default 9. Reset c/s 10. Display total operation time 11. Restart Pump

29

Screen Serial Number Manual Calibration Main Self-test Volume Test Manual Tests Keypad Test Display Test Sound Alarm Test Door Sensor Test Air Sensor Test Temperature Test Motor&Encoder Test Pressure Sensor Test Exit Pressure Cal. Pressure Calibration Factory Setting Reset Calibrations Hour Counter Restart Pump

Automatic Calibration The Noa III pump has many functions that allow the biomedical department to specify the device to every department. To access those functions a code is required (911).

Volume Calibration 1. Press continuously on the info key while switching the pump on. Hold pressed

the (i) info key until display will show the software version. After 5 sec. the message on the display will change to code. 2.

3.

4.

5.

6.

7.

Using the numeric key set code 19150 and confirm by pressing START/OK key.

Technician Code

19150

Use the arrow keys to scroll to “volume calibration” option and choose this option, using the START/OK key. The display will instruct to prime the set. Load a NoaSet and prime it (by pressing the syringe key and confirming with start/ok.

STOP Prime tube Press OK to continue.

Use a bag with desalinate water. Prepare a Vol Autocalibration container to infuse about 20 ml. Press the START/OK key to start infusion. The display will show rate and actual calibration, use the arrow 8.5 ml 21 keys to modify, press ok key when the calibration figure is ok. Repeat this procedure for all rates dispplayed. Calibration equipment: We recomd using a analytical scale , pc computer with Infuscal (tuv) software..

INFUSCAL (TUV) DATA COLLECTION SYSTEM

The pump will use the information of the actual delivery, and will calibrate itsself automatically. User may check the volume calibration by choosing volume test option. 30

1.

Automatic pressure calibration 1. Same as volume calibration select “Pressure Calibration “. 2. Load a NoaSet and primed it, with an “y” connection. 3. Connect a pressure gage, to one end of the “Y”. The display will show the actual pressure. 4. With the pump’s door open allow the pump to set the pressure value to 100, press ok key. 5. Close the pump’s door; press OK to confirm the zero level pressure. 6. Increase the pressure level up to 14 PSI, pressing arrow up. 7. Press the OK once the pressure gage will show 14 PSI. 8. Increase pressure to 30 PSI, and confirm with OK key. 9. The pump will use these values to automatically calibrate

pressure. User may check setting by selecting pressure test option.

Pressure Setting On the adjust setting option user can select 3 pressure levels (see p. 21).

31

Changing Current Program: 1.

Switch the pump on (press until the self-test screen appears).

2. When the screen of Rate appears, press info key twice. 3. Use ARROW keys to scroll to "Adjust Setting" option.

Volume Infused Show Setting

=> Adjust Setting 4. Choose "Adjust Setting" with START/OK key. 5. Use ARROW keys to scroll to "More".

Buzzer level

=> More … Show Setting

6. Confirm with START/OK key. 7. Set technician Code (Code 2008), using the ARROW keys and confirm with START/OK key. 8. Scroll through the setting parameters, using the ARROW keys, until the "Select Program " option. Confirm with START/OK key.

Technician Code

2008

Pressure Default

=> Select Program Priming Volume

9. Choose the required program, using the ARROW keys, and confirm with the START/OK key. 10. Chose “Restart Pump” Option and confirm with

Select program:

=> RATE RATE/VOLUME History

=> Restart Pump

the START/OK key.

Pressure Default



Note:

The selected program will remain in the pump’s memory until changed by user.

32



Note:

User may change programs using the Short Way:

1. When switching the pump on, after a short Self Test, the pump will display the last selected program for 5 seconds. During this time press STOP/NO key continuously for 10 seconds (Pressing any other key will elapse the pump to the Rate screen).

R A T E

2. The screen will show the “Program Select” menu.

Select program:

RATE PROGRAM

=> RATE RATE/VOLUME

3. Choose the required program, using the ARROW keys, and confirm with the START/OK key.

33

Unpacking: 1.

Carefully remove the pump and Charger from the box.

2.

Make sure no items were damaged during shipment

3.

Make sure you have the following items: 

Noa III enteral nutrition Pump



Charger



Battery Pack



Power cord



Operator’s Manual



Carrying Bags (small / large, optional)

If any items are missing or damaged, contact your Noa III dealer.

Loading the Administration Set 

Note:

1.

Lift the door latch to open the pump’s door.

2.

Insert the IV tubing into the tubing guide, following the direction flow label located above the tubing slot. Insert the tubing from left to right, and avoid stretching or pulling the tubing. Check key is located in correct position.

3.

Ensure that the distal set is on the right hand side of the pump.

4.

Close the pump’s door. Press on the door to close firmly, ensure that the latch is correctly applied.



Note:

Follow the Instructions supplied with the individual administration set. Use of any administration set, other than the NoaSet, may impair the operation of the pump and the accuracy of the Infusion.

Ensure that the tubing is inserted completely into the pumping channel.

34

IV Set Requirements The Noa III pump should be operated only with the Noaset. The Noaset administration set is supplied with an integrated valve (see drawings below).

No 1 2 3 4



Description

Function

NOAset Spike

Connects the administration set to solution bag NOAset drip chamber Displays infused drops, from the administration bag to the patient Administration Tubing 3x4.1 PVC free tubing Valve luer lock male Connects the set to the administration set connector cannula

Warning:

Do not operate the pump with any administration set, other than the NoaSet. Using a different set may essentially change the delivering rate.

35

NoaValve (Optional) The NoaValve enhances pump functioning by: 1. Preventing free-flow in the event the set is detached from the pump,

2. Preventing free-flow in the event of a mechanical malfunction. 

Note:

It is recommended to change the administration set every 24 hours to lessen incidence of bacteria formation. The Piston mechanism of the pump maintains optimal accuracy even if the same section of the administration set tubing (along the inner door side of the pump) is used continuously for 24 hours.

36

Priming Function Only the NOA III enteral Pump can prime the NOASet nutrition set. Priming Function is used: 1.

Before starting a program (see instruction below);

2.

After air in line alarm, as follows:  Press STOP/NO key to mute the alarm.  Press the SYRINGE key to push air bubbles through.  When priming completed press START/OK key to resume program.

NOTE:

When switched on and loading an unprimed administration set, The pump automatically enters prime option .

Priming operation 1.

Switch on the pump using ON/OFF key. (Press until the self-test screen appears). After a short self-test, the pump will display the program setting and status followed by the last setting rate.

2.

Press the SYRINGE key to prime the nutrition set.

PRIME Press OK to start

3.

Press the START/OK key to start priming.

4.

The display will show a graph indicating the PRIME priming operation. 0

10 ml

20

5.

Once the priming is completed, the display will change back to the previous screen the pump was in, before priming.

5.

Press the START/OK key to display the volume; Pressing again the START/OK key will start the program.

 Note:

The priming program is performed at maximum rate (no less than 600 ml/h). During priming the air in line alarm is disabled. 37

Noa III-Operating Before attaching the Noa III to a patient, run the following tests to verify that all indicators and alarms work properly. When an alarm is activated the following will occur: 1.

An alarm message will appear on the display.

2.

An audible alarm will be sounded.

3.

Infusion will cease.

Pump Operation Test: 1.

Click the pump into a Charger connected to AC power. Verify that the CHARGE indicator is on (on charger).

2.

Load an administration set in the pump (as described on page 21).

3.

Switch on the pump using the ON/OFF key (press until the self-test screen appears).

ON OFF

4.

The pump will display "Self Test" followed by the program selected and its status. During the self-test a long beep will be performed. This procedure verifies that the pump’s acoustic and visual features are working properly. After overview, the display will show the last rate setting.

5.

Press the SYRINGE key to flush the administration set.

Prime Press OK to start

6.

Press the START/OK key to start flushing.

7.

The display will show a graph indicating the FLUSH flushing operation. 0

2 ml

4

8.

When flushing is completed, wait without Pump Unattended pressing any key. Verify that when two minutes have passed without any key being pressed an audible alarm is activated and a Press start key “Pump Unattended” message appears on the display.

9.

Press the START/OK key to silence the alarm. 38

Air in Line - Alarm Test: 1.

Lift the door latch to open the pump door. Insert a NoaSet in the tubing guide of the pump.

2.

Close the door. Press the door until a click is heard.

3.

Set the infusion rate at 500ml/hr, using the arrow keys.

Rate

500 ml/h

Press OK for Volume 4.

Set Volume at 20 ml.

Volume

20 ml

Press OK to start 5.

Press the START/OK key to start operation. Turn the drip chamber (applicable to NoaSet only) upside down, to allow an air bubble greater than 5 mm to enter into the administration set.

6.

AIR alarm will be activated as soon as the air bubble enters the set segment located behind the pump door.

7.

Press the STOP/NO key to turn the alarm off.

8.

STOP appears on the display.

Air in Line Clean air

STOP 2 min Press OK to start

39

Door Open - Alarm Test: 1.

Insert an administration set into the pump and flush it.

2.

Set the infusion rate at 500ml/hr.

Rate

500 ml/h

Press OK for Volume 3.

Set Volume at 20 ml.

Volume

20 ml

Press OK to start 3.

Press the START/OK key to start operation.

4. Open the pump door. 5

Door Open alarm will be activated at once.

Door Open Close door

6.

Close the door.

7.

STOP appears on the display.

STOP 2 min Press OK to start

40

Down Occlusion - Alarm Test: 1.

Insert an administration set into the pump and flush it.

2.

Set the infusion rate at 500ml/hr.

Rate

500 ml/h

Press OK for Volume 3.

Set Volume at 20 ml using the numeric keyboard.

Volume

20 ml

Press OK to start 4.

Occlude the administration set (between the pump and the patient).

5.

After 10 seconds Down Occlusion alarm will be Down Occlusion activated (At a rate of 60 ml/hr the Down Occlusion alarm will occur after 60 sec. at a rate Press STOP to mute of 1 ml/hr after 13 min.)

6.

Press STOP/NO key to silence the alarm.

7.

STOP appears on the display.

STOP 2 min Press OK to start



Note:

The pressure threshold can be changed to suit patient need (see Changing the current default Pressure Limit, page 31)

Charge Indicator Test: 1.

Click the pump into the Charger, connect the Charger to the mains and check on the Charger that the pump's battery is being charged (red led for charging and green led if the battery is full). Disconnect the power cord from the AC power outlet.

2.

Verify that the CHARGE indicator is off.

3.

Connect the power cord to the AC power outlet. Verify that the CHARGE indicator on the Charger is on.

41

Basic Operation The Noa III pump was designed for the Alternate Site market. The pump can be used in a carrying bag or on an IV pole in the patient’s home.

Carrying bag:

Using IV pole (connected to a charger):

42

Connection of Pump to IV Pole 1.

Connect the NOAset to the feeding bag. Mount the bag on an IV pole.

2.

Click the pump into the Charger. Mount the Charger on an IV pole.

3.

Connect the Charger via a standard power cord to a grounded AC outlet.

4.

Open the door of the pump and insert the nutrition set into the pump’s tubing guide (as described on page 18)

5.

Switch the pump ON using the ON/OFF key (press until the self-test screen appears).

6.

The program and status will appear on the V O display for a few seconds.

RATE/VOLUME

L U

7.

The first screen shows the last rate setting in ml/h.

Rate

PROGRAM 500 ml/h

Press OK for Volume 

Note:

Press the ARROW UP key

to increase the units or the

ARROW DOWN key decreases the units. Press the ARROW keys consecutively for individual unit changing. Press the ARROW keys continuously for sustain unit changing.

8.

Prime the nutrition set, using the SYRINGE key.



NOTE:

9.

Continue according to the relevant instructions for every program.



Note:

10.

Verify that infusion is proceeding normally before leaving the pump unattended.



Note:

 “9999” can be changed to “0” by pressing the up arrow key.

If the START/OK key is not pressed within two minute, a “Pump Unattended” alarm appears on display. Press STOP/NO key to stop the alarm. The display will show STOP.

To change any parameter during operation, first press the STOP/NO key. STOP appears on display. Use the ARROWS keys to Scroll down the various settings. Set the desired Rate or VTBI and press START/OK key to start operation. The pump’s memory retains all parameters even if turned off. 43

Portable Connection: 1.

Connect the NOAset to the feeding bag.

2.

Open the door of the pump and insert the nutrition set into the pump’s tubing guide (as described in page 18)

3

Switch the pump ON using the ON/OFF key (press until the self-test screen appears).

4.

The program and status will appear on the V O display for a few seconds.

RATE/VOLUME

L U

5.

The first screen shows the last rate setting in ml/h.

Rate

PROGRAM 500 ml/h

Press OK for Volume 

Note:

Press the ARROW UP key

to increase the units or the

ARROW DOWN key decreases the units. Press the ARROW keys consecutively for individual unit changing. Press the ARROW keys continuously for sustain unit changing.

6.  7.



Prime the nutrition set, using the SYRINGE key. NOTE:

 “9999” can be changed to “0” by pressing the up arrow key.

Continue according to the relevant instructions for every program.

Note:

If the START/OK key is not pressed within two minute, a “Pump Unattended” alarm appears on display. Press STOP/NO key to stop the alarm. The display will show STOP.

8.

Verify that infusion is proceeding normally before inserting the pump into the carrying bag.

9.

Insert the bag and pump into the carrying bag.



Note:

To change any parameter during operation, first press the STOP/NO key. STOP appears on display. Use the ARROWS keys to Scroll down the various settings. Set the desired Rate or VTBI and press START/OK key to start operation. The pump’s memory retains all parameters even if turned off.

44

Hospital Service Procedures Introduction This section contains a table describing preventing maintenance, which should be performed on the Noa III Pump. The maintenance procedures outline in this section may be performed in the hospital, or home care provider, by the Biomedical department. If an abnormal condition occurs, which is not correctable by performing the following procedures, remove the device from service and troubleshoot in accordance to troubleshooting table on p. 15-17, or return to service.

Replacement of power fuses 1. 2. 3. 4. 5. 6.

Remove the pump from charger. Connect the charger to mains. Check that the AC icon is displayed. Remove the power cord from AC power outlet. Separate the front and rear charger housing. Remove the fuses from the fuse socket on the charger PCB, and check, using an Ohmmeter, electrical continuity. 7. If necessary, replace with a new fuse of same value, type and voltage. 8. Replace and tight fuses in the fuses housing, mount the fuses housing cover.

Battery protection fuse The battery protection fuse is located on the motor PCB of the pump (F1). The nominal of the battery protection fuse is 1.2 A (slow blow). 1. Check electrical continuity of F1. 2. Replace if necessary with a new fuse of same value, type and voltage.

45

Fuse –nominal (charger) 2 safety fuses, protecting the AC/DC converter are located on the charger PCB. The nominal requested values of the fuses are as follows: F1 = 1A F2 = 1A The AC to DC Converter is suitable for 220v and 110v as well.

46

Preventing Maintenance The following table presents a list of problems, check and correction to aid the diagnostic of possible pump malfunction. Review this list whenever a condition exist that does not appear to be normal. Perform the specified checks and corrections. If the problem cannot be corrected, remove the pump from service and troubleshoot in accordance to troubleshooting table, or return to service. Function The charging led does not illuminate when the charger is connected to AC. The red battery indication does not illuminate while the pump is connected to charger AC connected The green battery indication does not illuminate while the pump is connected to charger AC connected after more than 5 hours Missing Key

Battery output below 7.2V

Air alarm

Battery charging led does not lit

Test Remedy Check the tightness of Press the power plug power plug into the firmly into the AC outlet. AC outlet. Check F1 on Replace fuse if required BGMotor Replace battery if Check battery output required Check output of Replace battery if battery required

Check set loading in the pump Check pressure calibration Check the charging voltage. Check the device for continuity. Check administration set location

Replace set if required. Recalibrate pump pressure if required. If voltage below 8.4V connect the pump to a correct charger.

Position the tubing properly in the pump.

Check roller clamp open

Open roller clamp

Check correct type of administration set Check battery voltage > 8.1V

Replace with a correct administration set. Calibrate charger voltage to output 8.1.

47

Schedule: at least every 12 month or as required Check Check pressure sensor operation

Pressure Setting

Pressure calibration Check air sensor

Main Self Test

Batteries Li-Ion 7.2V

Display 122X32 Graphics

Action Access technician mode, as described on p. 29 and select pressure test option. Test pressure sensor accordance with instruction. If delta is less than 13, replace it. Access “Adjust setting”, as described on p. 27-28 and check pressure setting. Confirm or change it. Refer to P. 31. Check the air sensor output on UP, if pulse from pick to pick is less than 360 mV replace it. Access technician mode, as described on p. 29 and select “Main Self Test”. The pump will self test the following features: a. pump keys – pass/fail b. display – visual check of pick cells. c. buzzer – all level setting d. air sensor – pass/fail e. door – open/closed f. motor operation – pass/fail Check backup battery pack voltage. Check battery output after 4 hours of charging. If the backup battery is not within specification, replace it. Battery capacity are 1450 mH should operate more than 12 hours on a rate of 125 ml/h. Switch the pump ON, check all pick cells illuminate.

Note: User may perform all pump functional testing in the “Adjust setting” mode, selecting “main test”.

48

Schedule: at least once a month or as required Check Pump Housing

Pressing plate Battery time

Power cord Safety (CF)

Action Clean with an agent, as described on next page. Replace any labels that are damaged. Check that the plastic housing is completed. If the pressing plate does not operate smoothly, clean or replace. Connect the pump to charger, connect charger to AC outlet for 4 hours. Check that after less than 4 hours the battery red indication will change to green. When charging battery (battery led is red) Check that charging time is longer than 2 hours. Charging time indicates the battery capacity. When charging time (from low battery indication) to green led is shorter than 2 hours, replace battery. Replace the power cord if the pins are bent or the isolation is damaged. Check ground resistance measures on the charger clamp. If it is grater than 0.1 Ohm check tightness of grounding screws. It should be 100 micro amps or less using UL2601 specified test methods (CF classification).

49

Cleaning and Storage Before the transfer of a pump to a new patient and periodically during use, clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution. Warning: Before cleaning always switch off and disconnect from the AC power supply.  CAUTION Do not clean pump with chemicals such as Xylene, Acetone or similar solvents. These chemicals cause damage to plastic components and paint.

If the pump is to be stored for an extended period it should be first cleaned and the battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packaging for protection. Once every 3 months during storage, carry out functional tests and ensure that the battery is fully charged.

50

Battery Operation The Noa III can operate on battery power, enabling operation when the patient is being moved or during electrical power failure. When the pump runs on the battery power, the AC icon is off. At full charge, the battery provides 9 hours of operation at an infusion rate of 250ml/hr. 

Warning



Note:

Don’t operate the pump on AC power if the battery is not loaded in the pump for back up.

When the pump is not in use, click the pump into the Charger and plug the system into an AC wall outlet (if possible) to charge battery.

After the “end battery“ signal has been activated or following long periods of storage, wait 2 minutes after the pump has been connected to an AC power supply before operating. There are two battery alarm conditions: 

Note:

1. The pump will warn that the battery is low a

minimum of 30 minutes before the “end battery” alarm activates (when the battery power reaches less than 7.1v). 2. After the “battery low” warnings, when the

battery power reaches less than 6.05v, the pump will cease operation and the "end battery" alarm will be activated.

Low Battery Connect to charger

End Battery Connect to charger

 If the battery runs out, End Battery appears on the display. The pump stops

the infusion.  From the "end battery" state the user cannot restart the pump, unless it has

been connected to mains. 

Caution:

Leaving the battery in a discharged state for a long period of time may damage the battery.



Note:

Whenever possible, use the pump connected to an AC power supply via the charging unit. This preserves the battery power supply for emergency use or for situations where the AC power is not available.



Note:

Replace the battery once every four years. 51

Testing Procedures Function

Pump housing Display and led test

Air sensor

Test

Check that all parts are in place. Clean dirty area with an agent, as specified on page 51. Switch the pump on, check that all pick cells and operation led light. Check distance between sonsor door and front, should be 2.2 mm (plus minus 0.1 mm). Check pick to pick on JP4 – pin 1. Value should be greater than 400 mV.

Perform air sensor test – on technician mode , use stiff set; when unprimed set is in the pump – pump should display air massage and when the set is primed pump should display liquid massage. Motor sensor Check using an oscilloscope motor maximal reading value channel l on JP2 – pin 3. Rotate manually the encoder and check sensor position l (should be >4.5v) and zero (