NIKI T34L Service Manual March 2007

Service & Repair Manual

03/11/2008

T34L Syringe pump 3

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2

1

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1. 2. 3. 4. 5. 6.

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5

11

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Barrel Clamp arm (detects Syringe size/width of barrel) Syringe ear/collar sensor (detects correct loading of syringe collar) Plunger Sensor (detects correct loading of syringe plunger) LCD display (back-light (can be disabled) when any key pressed) Operation LED (green shows infusing (can be disabled), red when Stop or alarm) Info key (a. shows Event Log, Volume Infused, Volume To Be Infused and Battery

status b. Long press will Lock/Unlock Keypad) 7. Plus key (a. increase infusion parameters during programming/use. b. scrolls between options) 8. Minus arrow key (a. decreases infusion parameters. b. scroll s between options) 9. YES/START key (confirms choices during programming) 10. NO/STOP key (takes user back a step during programming, stops pump) 11. FF (Forward) key (moves actuator forward when no syringe present) 12. Back (Reverse) key (moves actuator backward when no syringe present)

13. ON/OFF key 14. Infra Red led 15. Syringe actuator cover 2

Service & Repair Manual

03/11/2008

Table of contents Introduction... 4 Terms used in manual ... 4 Alarms Conditions ... 5 Info Mode... 6 Access Code List... 7 Technician Menu... 9 Maintenance Flow Chart... 10 Operational Checklist ... 11 Trouble shooting ... 14 Battery Operation ... 24 Service Information ... 25 Failure Identification ... 25 Corrective Actions... 25 Volume Test ... 29 Occlusion pressure calibration ... 30 Syringe travel Calibration... 32 Syringe Diameter Calibration... 33 Change Set-up ... 34 Lock Mode ... 36 Service and Maintenance ... 38 Symbols, Warnings and Cautions ... 39 Intended Use ... 40 Warnings... 40 Service Centre Recommended Part List... 42 T34L Syringe pump Default Settings... 43 LIMITED WARRANTY... 45 Drawings ... 46

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Service & Repair Manual

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Introduction • • • • • • •

The T34L Syringe pump provides the following features: Small, light and compact pump. Accuracy +/-5% Ability to download current patient history & last 500 events Post-occlusion bolus prevention Free flow protection built into sets 3 secure lock levels of keys and program

Infusion Rate: 0.1 to 1000 ml/hr.

Operated with a customized safe administration set

Can be pole mounted

Silent operation

BEFORE ATTEMPTING TO CARRY OUT ANY PROCEDURES DETAILED IN THIS SERVICE MANUAL YOU MUST HAVE BEEN TRAINED & CERTIFED BY EITHER CME PERSONNEL OR AUTHORISED TRAINER. YOU WILL ALSO NEED A COPY OF THE USER OPERATIONS MANUAL AT HAND FOR REFERENCE.

Terms used in manual Warning: Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand this manual and all warnings completely before operating the T34L Syringe pump. Caution: Indicates that the information is a caution. Cautions advise you of circumstances that could result in damage to the device. Read and understand this manual and all cautions completely before operating the T34L Syringe pump. 

NOTE: Indicates that the information that follows is additional important information or a tip that will help you operating the T34L Syringe pump.

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Service & Repair Manual

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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. The operation LED will light Red. • An audible alarm sounds. • The infusion stops.

Alarms • Down Occlusion • Pump Unattended • Low Battery • End Battery • Internal Malfunction • End Program • End Travel • Syringe Displaced • Near End 15 minutes before completion. The “Troubleshooting Table” describes the pump’s alarm conditions and remedies.

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Service & Repair Manual

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Info Mode Pressing on the INFO key during operation will display Volume Infused the total Volume To Be Infused and the Infused Volume. The screen will be displayed for 7 seconds. VTBI 3.8 Pressing twice on the INFO key during operation will display the battery status.The screen will be displayed for 7 seconds.

Battery Level 98%

Empty



VI 1.3

Full

Note: Exit from the INFO mode is automatic after 10 sec, or can be achieved by pressing the INFO key.

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Access Code List The T34L Syringe pump has 2 access codes & a Key lock feature to control user access to authorized personnel only and prevent tampering. Service technicians will need to be familiar with these codes to access all areas of the pump to effect service and repair. Code ‘99’ – Access to pump “Change set up”, Allows locking program parameters. Code123– Allows authorised technicians to access testing & service menu. Key lock – enables user to lock all but the info & Stop keys to prevent tampering with the pump.

Before performing any maintenance procedure:a. You must have training & certification from either the manufacturer or distributor and have the recommended equipment and authorised spare parts at hand to perform the required maintenance or repair. b. Check the History events to define the frequency & nature of the complaint, and record program and calibration settings at the time of the event.

c. Enter the technicians menu (power up the pump by holding down the INFO & POWER key simultaneously until the Technician Code prompt appears). Enter code 123. Press YES key to confirm.

Scroll to and perform ‘Main Self-Test’ and record any failures or issues identified during the test.

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Service Decision Pathway When a T34L Syringe pump is returned for service or repair after a ‘fault’ is reported by a user always request a full explanation and description of the fault experienced by the user and, if possible and appropriate, ask for the return of the administration set in use at the time of the fault. Be mindful of the following factors as part of the service/repair procedure: 1.

Has the user operated the pump correctly? Cross reference their report with the Operations manual to ensure the steps they took prior to the alarm did not cause or result in the alarm state or error cause.

2.

Was the faults in one of the pump sensors (identify which one and replace it) or one of circuit boards (identify which PCB failed and replace the board). Use on the technician mode, either "main self test" to pass all the testable option or "manual test" to select a specific function.

Possible Issues: -

Corrective Action: -

1. User error

Refer issues back to department lead and suggest training/alerting all users to prevent the same error being repeated. Check correct Syringe used. Is it on the approved list of syringes?

2. Fault with Syringe or administration set 3. Failure of pump 3. Mechanical failure 4. Electronic failure 5. Failure of sensors: Syringe detection, sensors 1-3.

Perform Main-Self test on Tech menu Change the defective part Change the relevant PCB Replace the module.

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Technician Menu To access the technician menu, press and hold the INFO key and POWER button at the same time until “Technician code” prompt appears. The display will show the software version for 2 seconds before the access code prompt. Enter code 123 to access the technical menu. The pump will display all the parameters that can be set, calibrated or tested. The technician can scroll through all parameters using the ARROW keys . Menu Item 1 2 3

Setting Exit from Technician Serial Number Main Self-Test

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Manual Test

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Syringe Set-up

6 7 8 9 10 11 12 13

Pressure Calibration Factory Press. Test Pressure Test Syringe Travel Diameter calibration Syringe Dead Space Volume Test Factory Setting

14 15 16 17

Operation Hours Service Interval Purge Volume Maximum Rate

Screen Exit Technician Mode Displays serial number & production date Runs through keypad, display, alarm sound, Syringe sensors test, Syringe diameter test, syringe travel test,Battery voltage test, exit. Same As main self test but with a menu to focus the user on individual tests. Adjust default diameter on the list of approved syringes. Allows calibration and pressure settings Fine tuning of pressure calibrations Tests actual pressure Calibration of syringe movement about 68 mm. Tests the syringe barrel sensor The actuator limitation to deliver all volume Performing flow rate test Caution – pressing START/YES will restore factory defaults and delete all pre-set protocols and set-up changes. Hours from last service. Number of hrs before Send for Service message Set Maximum volume user can purge. Set Rate Limit

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Maintenance Flow Chart Pump returned for service or repair Power up the pump, note serial number & software version & access technical menu

Log receipt, pump serial number & physical appearance (i.e. damage, signs of tampering)

Check history events and note type & frequency of alarms / alerts. Check the IV-SET and the liquid type that was infused (make a note of the set that was used. Note serial number.

Perform all tests in the Operational Checklist

Does device pass all tests on the Operational Checklist?

NO

YES

Recalibrate, if any repairs or disassembly has been undertaken.

Troubleshoot

Repair Record that the pump has passed service. Clean & return to user group.

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Operational Checklist Introduction The operational checklist detailed in this section determines if the device is operating correctly and should be carried out before and after any service or repair work. If the device fails any test in the checklist, the fault must be recorded & corrected prior to placing the device back into clinical use. Please become familiar with all checklist procedures prior to carrying out any tests. The following test equipment is required to perform the tests in the Operational Checklist: • Syringe 50/60 ml filled with tap water • Pressure gauge • Electronic Balance or burette or Infusion tester • Leakage Current testing device (for safety tests) • Connecting flat cable between the front and rear housing Once a problem has been identified and isolated to a single assembly, the assembly should be replaced in accordance with the disassembly procedures provided in this manual. After all repairs are completed, the operational checklist should be repeated and the device should be re-calibrated.

Pump Set-Up for testing Please ensure you have, & are familiar with, the device Operation Manual before performing these tests. The procedures in this section are designed to check that the Syringe pump is infusing correctly prior to testing the effectiveness of the alarms. If the pump fails to perform as described or displays an error cause – troubleshoot and repair before repeating the test. The pump will display Restart pump message, press the info key for more details. 1. Switch the pump on; allow preloading procedure to be completed. Verify that the syringe holder is set down. 2. Verify that all sensors (syringe holder, barrel ear and plunger ear) are blinking. 3. Load a syringe, verify that the pump detects the syringe size and brand; the pump may detect a different brand but never a different size. (see operations manual) 4. Select the correct brand and press yes to confirm. 5. The pump will display the calculated volume. Verify that the detection is correct, if not return to step 1. 6. Confirm or change data of time default, calculated rate, and the accumulation screen, start infusion. 7. Verify the operation LED colour does change from red to flashing green, . . 11

Service & Repair Manual

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INFUSION TEST The following test checks that the pump does not exhibit alarms or error causes during normal operation: -

1.

Switch the pump on using the on/off key. Allow preloading procedure to be completed.

2.

Load a syringe (refer to operation manual for approved list of syringes)

3.

Verify the pump will detect the syringe correctly, to confirm syringe type press the YES key or use arrow keys to select another brand.

4.

Verify the displayed volume, confirm with YES key.

5.

Change the calculated rate to 5ml/h and press YES, verify the warning screen will appear.

6.

Press YES key to confirm calculated/set rate.

7.

Check accumulated data on the screen and confirm.

8.

Press the YES key to start infusion.

9.

If the pump stops infusing and reports an alarm troubleshoot using the table on pg37

10.

Below is a list of events and alarms that can appear in the Event Log

Alarms

Operation events

1.Timer communication fail

a. event No

2. External EEPROM fail

b. Date & Time

3. Timer battery fail

c. Switch on

4. Internal EEPROM fail

d. info: Volume infused

4. Hardware reset

e. Volume to be infused

5. Setting test fail

f. Rate

6. Startup motor stop fail

g. Type of Syringe

7. Watchdog current

f. Length in ml/mm

8. Watchdog time error

g. Pressure settings: 0 - 10 psi

9. CPU test error

h. Pressure actual

10.Shadow compare error

i. Battery voltage

11.ADC converter fail

j. Rate Titration

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Service & Repair Manual 12.Oscillators fail

03/11/2008 k. Stop

13.STAC overflow

l. Low Battery

14.UPD counter overflow

M .Pump Unattended

15.External light fail

n. Down Occlusion

16.Revolution enc. Fail

o. End travel

17.No motor steps- 20 min

q. Syringe displaced

18.Motor voltage overflow 19.Long revolution time 20 Short Rev. time 21. Over Rev. in minutes 22. Less Rev .in minutes 21.No rotation detected 24. Actual Rate test err. 22.Startup motor move fail 23.Ends sensors fail 24.Current sensor fail 25.Syringe type diameter 26.Wrong volume leng 27.Long stop mode int. 29.Reset by COP counter 11.

To restart infusion, press the START/YES key.

12.

When the pump has delivered the selected volume, an audible alarm will be activated while the display will show “Program End” and default to ‘KVO’ if enabled. To stop the alarm, press the STOP/NO key.

13.

Check that the pump is infusing the KVO rate.

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Trouble shooting Alarms or Complaints Volume Accuracy is not accurate

Pressure Accuracy is not accurate -Pump does not switch on

Pump will not perform preloading The FF & BACK keys will not function

Purge disabled Volume can not be increased Syringe holder sensor not sliding Operation LED malfunction Maximal basal rate limited Rate Titration disabled

Possible cause

Action

Wrong detection of syringe, or incorrect setting of hard height.

1. Check that the correct syringe was selected. 2. Perform Syringe Travel Calibration (tech menu) 3. Check Hard Height measurement in Tech menu Recalibrate pressure accuracy as described in pressure calibration section. Change Battery

If during maintenance the pressure readings are faulty Battery depleted On/off key malfunction 1. External interrupt or electronic malfunction (electrostatic discharge) 2. Encoder plate not mounted properly. 3. Encoder LEDs or phototransistors are damaged 4. In case motor can’t turn 5. If the problem consist The syringe holder is located in the upper position. 1. A syringe is loaded 2. Syringe holder is up 3. Syringe sensor malfunction

The pump was switched on, while a syringe was loaded. The pump will not allow to increase volume above the volume in the syringe Syringe detection sensor malfunction Operation LED is not working during operation The maximal rate setting was set to a lower value 1. In the Change set up the rate titration setting was disabled 2. Program is in lock state

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Replace the main PCB 1. Restart the pump.

2. Remount the encoder plate. 3. Replace Encoder PCB 4. Replace motor 5. Replace main PCB Set syringe holder to the down position. 1. 2. 3. 4.

Remove Syringe Place syringe holder down Replace syringe sensor. Check connection on the front pumping block. If it has no fault, replace slide potentiometer. Remove syringe, switch off and on again. Software protection.

Replace syringe holder Check set up, if enable or Change the main PCB Change the maximal rate to higher limit in ‘Change Set Up’ 1. Enable titration mode 2. Unlock program.

Service & Repair Manual Alarms or Complaints Down Occlusion Hardware Reset or Reset by external pin

Setting Test fail

03/11/2008

Possible cause

Action

Occlusion detection malfunction 1. External noise 2. 9V battery low or depleted 3. Battery contacts dirty 4.Mechanical malfunction 5. Motor PCB malfunction 6. Main PCB malfunction

Recalibrate pressure accuracy as described in pressure calibration section, replace main PCB. 1. Turn the pump off and on again and if problem continue send to manufacturer. 2. Replace battery 3. Clean battery contacts 4. Check motor and replace 5. Replace motor PCB 6. Replace main PCB 1. Turn the pump off and on again using the same syringe, and if problem continue send to manufacturer. 2. Enter technician mode and check the data for the current syringe 3. Restore data by performing Factory Setting 4. Perform calibration of : Syringe travel, syringe diameter and pressure calibration with 50 ml syringe 5. Enter those parameters and confirm 1. Turn the pump off and on again if problem continue send to manufacturer. 2. Check lithium battery or replace motor PCB 3. Replace main PCB. 1. Restart the pump. If problem continue sent to service. 2. Replace motor PCB 3. Replace main PCB 1. Check syringe, the pump is calibrated to operate with new syringes or replace pumping assy.

1. Ram corruption 2. Syringe data out of range 3, Data setting corrupted 4. Device not calibrated after main PCB replacement 5. Corruption of s/n, production date and dead space.

Long Stopmode int or Timer communication fail Reset by COP counter Startup mot or stop fail

1. Failure during switch on test 2. Motor PCB malfunction 3. Malfunction of Main PCB

Actual rate test error or Long revolution time or over revolution in minutes or less revolution in minutes Watch Dog Current

1. Mechanical Malfunction or High friction of syringe 2. End of travel, forcing against housing 3. See revolution encoder fail

1. External noise during switch on 2. Motor PCB malfunction 3. Main PCB malfunction Watch Dog time error Main PCB malfunction

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1. Turn the pump off and on again , and if problem continue send to manufacturer. 2. Replace Motor PCB 3. Replace Main PCB Replace main PCB

Service & Repair Manual

Alarms or Complaints Shadow compare error

Oscillator fail

Stack Overflow UPD counter overflow or Motor current overflow ADC converter fail

External light fail

03/11/2008

Possible cause

Action

1. Curruption Ram 2. MAIN PCB malfunction

1. Turn the pump off and on again , and if problem continue send to manufacturer. 2. Replace main PCB.

1. External noise due to electrostatic discharge 2. Water ingress 3. The connector between PCB –pins dirty 4. Lithium battery less than 3V 5. Motor PCB malfunction 6. Main PCB malfunction Microprocessor malfunction

1. Turn the pump off and on again , and if problem continue send to manufacturer. 2, Dry the device 3. Clean pins of connector between main and motor PCB's 4. Check and replace lithium battery. 5. Replace motor PCB. 6. Replace main PCB.

1. Mechanical malfunction 2. Motor PCB or connection to main PCB 3. Encoder PCB malfunction 4. Encoder plate loose External interrupt or electronic malfunction (electrostatic discharge) Electronic malfunction 1. Encoder detects external light 2. External noise 3. Malfunction of encoder PCB 4. Connecting cable between encoder and main PCB damaged 5. Main PCB malfunction

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Replace main PCB 1. Perform Syringe Travel calibration 2. Replace pumping block 3. Replace motor PCB and clean connectors. 4. Replace encoder PCB. 5. Fasten encoder plate Turn the pump off and on again. If problem continue replace main PCB. Replace main PCB 1. Make sure pump case is closed with 6 screw and not broken 2. Turn the pump off and on again , and if problem continue send to manufacturer. 3. Replace encoder PCB. 4. Check or replace 5. Replace main PCB.

Service & Repair Manual

Alarms or Complaints Internal EEPROM fail

Revolution encoder fail

No motor steps 20 minutes No rotation detected

03/11/2008

Possible cause

Action

Microprocessor malfunction

Replace main PCB

Memory malfunction

Turn the pump off and on again. If problem continued: 1. Perform factory setting, from the technician mode. If problem continued: 2. Perform reset calibration and calibrate the pump again. If problem continued: 3. Burn software again (refer to instructions. Do not save previous calibrations).Calibrate the pump again. If problem continued: 4. Replace main PCB. 1. Turn the pump off and on again. If problem continued send to Manufacturer. 2. Replace magnet on motor adaptor 3. Replace motor PCB. 4. Tighten encoder plate Replace main PCB

1. External noise 2. Magnet on motor adaptor, weak or disconnected 3. READ switch 1, 2 broken 4. Encoder plate loose Main PCB malfunction Encoder malfunction Motor malfunction

1. Turn the pump off and on again. 2. Replace block assembly. 3. Replace main PCB 4. If problem continues, send to manufacturer. Start up motor move 1. Lock at end travel 1. Move manually out of looking. fail 2. Mechanical or motor 2. Turn the pump off and on again. If problem malfunction continued replace pump mechanics. 3. Motor PCB malfunction 3. Replace motor PCB and check pins of 4. Malfunction of Main PCB connector to main PCB. 5. Encoder plates loose 4. Replace main PCB 6. Encoder or connecting flat 5. Tight encoder plates. malfunction 6. Check and replace encoder PCB and flat to main PCB. Ends sensor fail 1. Limit sensors malfunction, 1. Check or replace read switches 2. Magnet on actuator weak 2. Replace encoder magnet. 3. Flat cable malfunction 3. Check or replace flat cable Current sensor fail 1. Motor PCB Malfunction 1. Replace motor PCB 2. Main PCB malfunction 2. Replace main PCB Syringe type diameter Syringe diameter not calibrated Enter manual test and perform syringe diameter test , recalibrate if necessary. Wrong Vol. lengths Wrong data entered mm/ml Recalibrate syringe CPU test error Microprocessor malfunction Replace main PCB Timer 1. External noise during 1. Turn the pump off and on again and set communication Fail communication pump to operate on 0.1 ml/hr rate, if 2. Timer battery – low problem continue send to manufacturer. 3. Motor PCB malfunction 2. Check voltage on lithium battery, if less 4. Main PCB malfunction than 3v , replace battery 3. Replace motor PCB 4. Replace main PCB 17

Service & Repair Manual Alarms or Complaints Timer's battery Fail

External e-eprom fail

03/11/2008

Possible cause

Action

1. It is the first pump operation after service 2. 3V battery damaged 1. External noise during communication 2. Motor PCB malfunction 3. Main PCB malfunction

1. Turn the pump off and on again. 2. Replace 3V battery 1. Turn the pump off and on again and set pump to operate on 0.1 ml/hr rate, if problem continue send to manufacturer. 2. Replace motor PCB 3. Replace main PCB

Note: in order to prevent the possibility of wrong detection of syringes, we recommend using only approved brands. Avoid using brands that their external diameter is close, less than 0.5 mm. The medical institution will have to decide on one of them.

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Maintenance Introduction This section contains a table describing preventive maintenance, which should be performed on the T34L Syringe pump. The maintenance procedures outlined in this section may be performed in the hospital, by qualified and certified biomedical engineers. If an abnormal condition occurs, which is not correctable by performing the following procedures, remove the device from service and troubleshoot in accordance with the troubleshooting table, or return to manufacturer or distributor for service.

Maintenance Procedures Preventive Maintenance The following table presents a list of problems, tests 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 user service and troubleshoot in accordance to troubleshooting table, or return to service to manufacturer.

Schedule: at least once a month or as required Clean pump housing with a suitable cleaning agent, as described on next page. Check housing for damage and replace any labels that are damaged.

Schedule: at least every 12 month or as required Perform all above tests, and perform the following Functional Test Procedure

Functional Test Procedures Remove Program lock. To perform the following tests, the program lock should be disabled. To do so: 1. Switch the pump on allow Pre-Loading to complete. 2. Press the blue Info (i) key, then scroll down (using UP/DOWN arrow keys) to ‘Change Setup’ enter code 99 by using the arrow keys. Then press ‘YES’ to confirm code. 3. Scroll up the menu to ‘Program Lock’ press ‘YES’ to confirm selection. 4. Use either arrow key to change the Program Lock status from ON (default) to OFF. Press YES to confirm change. 5. Scroll down to ‘Exit’ Press ‘Yes’ to exit set up menu. By removing the program lock, this enables you to change the default duration so that the infusion rate available for these tests is anything up to the 5ml/hr maximum set under the Technician Menu. 19

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Syringe Recognition and volume detection test. Equipment needed: • •

T34L Syringe Pump Selection of syringes used in the Hospital or Trust.

Method 1. Switch the pump on and allow Pre-loading to complete. Position of the carriage should not be important except possibly for some smaller syringes where the actuator may have moved beyond the fully extended size of the syringe. Use the FF key to move the actuator to the desired position. FF key movement is limited for safety reasons so repeated presses may be necessary to position. For each of the syringes: 2. Lift the barrel clamp arm and place the syringe on the pump as described in the Operations manual ensuring the collar/flange and plunger are position correctly. Place the barrel clamp arm down on top of the syringe barrel. 3. The LCD screen should show the LOAD SYRINGE message and after a few seconds a volume and brand. If this screen remains with parts of the syringe graphic flashing (or a message is shown) check the loading of the corresponding syringe part or follow the message to complete correct placement of the syringe. 4. The pump should ALWAYS display the correct volume but may not always immediately give the correct brand. Use the arrow keys to scroll through the list of syringe brands (pump shows those within +/-3% diameter of the one loaded). Select the correct syringe brand and Press Yes to confirm selection. 5. Read the actual volume on the syringe and compare it with what the pump reads the volume as, these results should be within +/-3%. If the result does not fall within the expected range: a. Check that there is no slack in the system (visible space in the seating of the plunger or the collar/flange. In such cases purge may be required before repeating the test (refer to Operations Manual) b. Re-check that the syringe loaded is the same brand as confirmed at step 4 i. If the error remains outside of specification after checking point a & b then the pump has failed the test and corrective action is required. 6. Remove the syringe, turn the pump off, place the arm down and repeat steps 1-5

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