Service Manual
107 Pages
Preview
Page 1
T34L Syringe Pump Infusion System
SERVICE MANUAL Including T34L, NeoFeed, SP3000, PCA models
0344
Manufacturer: Caesarea Medical Electronics Ltd. International Toll Free. +800-323-575-00 European address:
Staufenburgstr. 23 Lichtenstein P.o.b. 1248 Lichtenstein 72805 Germany
E-mail: [email protected] www.cme-infusion.com
Ref: 100-091SL February 2010
T34L Syringe pump
1 3 6
2 5 4 15
14
12
8
10
9
11
13
7
Figure 1 T34L syringe pump
1. Syringe holder arm (detects Syringe size/width of barrel) based on barrel diameter 2. Syringe ear/collar sensor (detects correct loading of syringe collar) 3. Plunger Sensor (detects correct loading of syringe plunger) 4. Graphic LCD display (128 pixels x 32 pixels, the backlight duration is settable; when any key is pressed the backlight turns on).
5. Operation LED (green shows infusing, red when Stop or alarm, can be disabled) 6. Actuator (drives the syringe plunger to deliver syringe contents) 7. Info key (a. shows Event Log, Volume Infused, Volume To Be Infused and Battery status b. Long press will Lock/Unlock Keypad)
8. Plus key (a. increase infusion parameters during programming/use. b. scrolls between options)
9. Minus key (a. decreases infusion parameters. b. scrolls between options) 10.YES/START key (confirms choices during programming) 11.NO/STOP key (takes user back a step during programming, stops pump) 12.FF (Forward) key (moves actuator forward when no syringe loaded) 13.Back (Reverse) key (moves actuator backward when no syringe present) 14. ON/OFF key (turns the pump on and allows turning it off from Stop) 15. Infra Red Communication Port.
Page 2 of 107
Table of Contents T34L Syringe pump ...2 Figure 1 T34L syringe pump ... 2
INTRODUCTION...6 GENERAL...6 SAFETY ... 6 SYSTEM SYMBOLS ...6 DOCUMENT NOTICES...7 WARNINGS ...8 CAUTIONS ...9 ELECTRICAL SAFETY COMPLIANCE ...9 ELECTROMAGNETIC COMPATIBILITY (EMC) ...9 ALARMS ...9 Alarm conditions ...9 Alarm types ...9 PRE-SERVICE ... 10 PRE-SERVICE CHECKLIST...10 SERVICE DECISION ROUTE...10 SERVICE PROCESS FLOW CHART ...12 SERVICE INFORMATION ...13 FAILURE IDENTIFICATION ... 13 T34L SYRINGE PUMP DEFAULT SETTINGS ... 14 ACCESS CODE LIST ... 17 LOCKING ... 17 KEYPAD LOCKING ...17 PROGRAM LOCKING ...18 MAXIMAL RATE LOCKING ...18 OPERATIONAL CHECKLIST AND CALIBRATION TESTS ... 19 INTRODUCTION...19 CHECKLIST ...20 SETTING UP THE PUMP FOR TESTING ...21 INFUSION TEST ...22 VOLUME TEST ...22 OCCLUSION PRESSURE CALIBRATION ...23 FACTORY PRESS. TEST ...24 PRESSURE TEST ...26 SYRINGE TRAVEL CALIBRATION ...27 SYRINGE DIAMETER CALIBRATION ...27 DISASSEMBLY ... 29 TOOLS AND TEST EQUIPMENT ...29 PUMP DISASSEMBLY / ASSEMBLY ...30 A. Separation of front and rear housing ...30 Figure 2 Back housing screw assignments ... 30 Figure 3 Separating front and rear housing ... 31
B. Replacement of motor and pumping block ...32 Figure 3 Upper label uncovered fixing screw ... 32
Page 3 of 107
Figure 4 Disconnecting the motor connector ... 32 Figure 5 Pulling out the block assembly ... 32
C. Replacement of PCBs – motor and main ...33 Figure 6 Releasing the spacer fixing screws ... 33 Figure 7 Disconnecting display from main PCB ... 34 Figure 8 Removing protective seal from buzzer ... 34
D. Replacement of pump motor ...35 Figure 9 Required tools (left), releasing the wire connectors (right) ... 35 Figure 10 Releasing the motor from the block ... 36 Figure 11 Separated motor and front block ... 36 Figure 12 Wiring placements ... 37
E. Replacement of rear PCB ...38 Figure 13 Soldered contacts ... 38 Figure 14 Collar sensor w/spring locker (left), removal of collar sensor (right) ... 38 Figure 15 Rear PCB fixing screws with washers ... 39 Figure 16 Rear PCB positioning ... 39 Figure 17 Treating rear PCB's potentiometer part ... 40 Figure 18 Sealing gap between rear PCB and housing ... 40 Figure 19 Collar sensor insertion ... 41 Figure 20 Metric feeler gauge (right), measuring 0.9 mm (left and bottom) ... 42 Figure 21 Adjusting the collar sensor contact ... 43
TECHNICIAN MENU ... 43 ENABLING AND DISABLING A SYRINGE TYPE IN THE PUMP MENU...44 INFO MODE DURING OPERATION ... 46 CHANGE SET UP ... 46 MAINTENANCE ... 48 MAINTENANCE PROCEDURES ...48 ROUTINE PREVENTIVE MAINTENANCE ...48 FUNCTIONAL TEST PROCEDURES ...48 Remove program lock ...48 Syringe Recognition and volume detection test ...48 Volume Delivery test. ...49 Occlusion Test ...50 Alarms Test...51 Restore Program lock. ...51 BATTERY OPERATION ...51 CLEANING ...52 STORAGE...53 COMMUNICATION (BETWEEN PC AND SYRINGE PUMP) VIA INFRA RED COMMUNICATION PORT ... 54 REQUIRED EQUIPMENT ...54 APPLICATION ...54 INSTALLING AND CONFIGURING BODYCOMM ON A PC ...54 Desktop shortcut ...54 Using RS232 communication for T34L models ...55 Figure 22 BodyComm Connections Setting screen ... 55 Figure 23 BodyComm initial connection message ... 55
Using BodyComm for setting/retrieving data ...55 Figure 24 Installing of Dongel... 56 Figure 25 Syringe Pump Connected screen (main screen) ... 56 Print Pump Settings... 57 Syringe Data ... 57 Figure 26 Syringe Data–Syringe Brands screen ... 58 Pump Setting ... 58 Figure 27 Pump Setting screen ... 58 Event Log... 59 Figure 28 Events screen ... 59
Page 4 of 107
Technician ... 60 Figure 29 Technician–Calibrations screen ... 60 Global Macro... 61 Figure 30 Global Macro Commands screen ... 61 Figure 31 Global Macro screen, new macro ... 62 Actual State ... 63 Figure 32 Actual State–Pump Connected screen ... 63
SERVICE CENTRE RECOMMENDED PART LIST ... 64 TROUBLESHOOTING... 65 DRAWINGS AND BOM ... 70 FRONT HOUSING ASSEMBLY ...70 BLOCK ASSEMBLY ...72 ACTUATOR ASSEMBLY...73 REAR ASSEMBLY ...74 PUMP ASSEMBLY ...76 MAIN PCB WIRING SCHEMATIC ...78 REAR PCB WIRING SCHEMATIC ...83 KEYPAD PCB SCHEMATIC...84 MAIN PCB ...85 Figure 33 Syringe main ver. 5A, assembly bottom ... 85 Figure 34 Syringe main ver. 6, assembly top ... 86
REAR PCB ...87 Figure 35 T34L rear, ver.3, assembly top ... 87 Figure 36 T34L rear, ver.3, assembly bottom ... 87
KEYPAD PCB...88 Figure 37 T34L Keypad, ver.3, assembly top ... 88 Figure 38 T34L rear, ver.3, assembly bottom ... 88
BOMS...89 APPENDIX A: LIST OF EVENTS AND ALARMS ... 93 APPENDIX B: SOFTWARE BURNING INSTRUCTIONS ... 94 EQUIPMENT ...94 BURNING STATION CONNECTIONS ...94 Figure 37 RS-232 burning station connector ... 94 Figure 38 RS-232 connector connected to burning station... 95 Figure 39 DC cable with wall charger connected to burning station ... 95 Figure 40 Burning station cable 5P connector connected to burning station ... 96 Figure 41 Burning station cable connected to PCB ... 96 Figure 42 Main PCB connected to burning station ... 97
PROCEDURE ...97 LIMITED WARRANTY ... 104 SPECIFICATIONS ...105
Page 5 of 107
Introduction General This manual provides instructions for the service of the T34L syringe pump and its software. The following requirements and conditions apply when performing service on CME products, failure to follow these instructions will invalidate warranty and creates unacceptable risk:
Service of T34L syringe pumps and accessories may only be performed by CME authorized service personnel. Service can only be performed with the recommended equipment and CME approved parts.
This manual is intended to support CME authorized service technicians performing service.
Clinical personnel, patients, and other users are advised to return syringe pumps to an authorized service center for service.
Refer to the operation manual for pump operation instructions, cautions and warnings.
Refer to BodyComm operations manual for BodyComm operation instructions.
Document the service performed in accordance with the service provider‘s prevailing procedures.
Safety System Symbols The following symbols are used on the T34L Syringe pump Infusion System and components. Labels on the system or statements in this manual preceded by any of the following words and/or symbols are of special significance, and are intended to help you operate the pump safely and efficiently. Attention, consult accompanying instructions.
CSA Mark
CE mark indicates conformance to Medical Device Directive 93/42/EEC. Do not dispose of in municipal waste. Symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2002/96/EEC). NOTE: Does not apply to the battery.
Page 6 of 107
Do not dispose of battery in municipal waste. Symbol indicates separate collection for battery is required. IPX1
Level of protection against fluid ingress The use of single-use disposable components on more than one patient is a biological hazard. Do not reuse single-use disposable components.
Type CF applied part.
Date of Manufacture Serial Number Expiry Date of disposable LOT ______
Lot Number
STERILE EO
Sterilized with Ethylene Oxide
Document Notices 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 operate the T34L Syringe pump.
Page 7 of 107
Warnings To avoid possible personal injury or loss of life, observe the following: Read the entire Operation‘s Manual before using the pump, since the text includes important precautions. The T34L syringe brand detection is based on physical dimensions of syringes used in the UK during the year 2006. However, same brand syringes may be manufactured at different sites bearing small differences which are beyond the control of the T34L manufacturer. Therefore, do not use the T34L if the correct syringe brand is not detected and promptly notify the T34L manufacturer. Always assure that the visual volume in the syringe matches the actual volume on the T34L screen. Before starting an infusion, check that all parameters set, especially calculated parameters, are correct. Visually Check that the volume in the syringe matches the actual volume on the pump screen and the calculated rate. In case the default duration is set to zero, set the required rate. The maximum volume that may be infused under SINGLE FAULT CONDITION depends on syringe size and brand and is equivalent to 3 motor revolutions. A kinked or occluded IV line may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the IV line is not kinked or occluded. Drugs must not be administered to the epidural space unless the drugs are indicated for this purpose and are administered in accordance with the indications included in the manufacturer‘s package insert accompanying the drugs. Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. The T34L Syringe Pump should be operated within a temperature range of 5C (41F) to 45C (113F) and at up to 85% humidity. Operating the pump at temperatures and/or humidity other than within this range may affect accuracy. Unsafe operation may result from using inappropriate accessories. Use only accessories and options designed for this system and supplied by manufacturer. Dropping the T34L Syringe Pump could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel. Use aseptic technique. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components and do not re-use single use IV sets or syringes. Make sure that the syringe brands used (at the medical provider) are enabled in the software, and all other syringes are disabled. When starting a new program allow the pump to perform preloading procedure as this procedure will assure correct detection of the volume in the syringe. Do not open the pump if connected to mains. It may cause severe injury.
Page 8 of 107
Cautions To avoid possible damage to the equipment, observe the following: Do not store the pump with battery for more than six months. Charge the pump periodically at least every three months. Xylene, acetone or similar solvents could cause damage to components. Do not clean the pump with these chemicals. Clean solution spills on the pump immediately. Use a damp cloth or sponge. A mild detergent may be used. Wipe thoroughly with a dry cloth. Immersing the T34L Syringe Pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid. Battery damage could occur if left in a temperature warmer than 50C.
Electrical Safety Compliance The T34L Complies with the following standards:
EN 60601-1 (Medical Electrical Equipment Safety)
EN 60601-2-24 (Safety of Infusion pumps and controllers)
IEC 60601-1-4 (Programmable Electrical Medical System)
UL 60601- 1 and CAN/CSA C22.2 No 601.1 (Medical Electrical Equipment Safety)
Electromagnetic Compatibility (EMC)
IEC 60601-1-2 (Electromagnetic Compatibility)
Alarms Alarm 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.
Alarm types
Down Occlusion
Pump Unattended
Low Battery
End Battery
Page 9 of 107
Internal Malfunction
End Program
End Travel
Syringe Displaced
Near End: The first of 15 minutes before completion or 15mm.
Syringe displaced Refer to the Troubleshooting section on page 65 for the alarm causes and corrective actions. Refer to Alarms Test on page 51 for instructions on testing the alarms.
Pre-service Pre-service checklist Before performing any service procedure: Authorized service personnel You must have training & certification from either the manufacturer or manufacturer-authorized personnel and have the recommended equipment and authorized spare parts on hand to perform the required maintenance procedures or repairs. Disinfection Disinfect the pump according to cleaning instructions as described in the user manual. Confirm Customer Information Confirm proper document record has been completed for Log receipt, pump serial number & physical appearance (i.e. damage, signs of tampering). Event log Check the History events to define the frequency and nature of the complaint, record program and calibration settings at the time of the event. It is recommended to download the event log and file a copy at the product history file. Manual review of pump settings Enter the Technician menu (power up the pump by holding down the INFO and POWER keys simultaneously until the Technician Code prompt appears). Enter the technician code: 123. Press YES/START to confirm. Scroll to and perform ‗Main Self-Test‘. Record any failures or issues identified during the test.
Service Decision Route When a T34L Syringe pump is returned for service, always request a full description of the service cause, and if possible and appropriate, ask for the return of the administration set in use at the time. Be mindful of the following factors as part of the service/repair procedure: Use the event log to determine last occurrences to challenge service cause. 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.
Page 10 of 107
Was the fault in one of the pump sensors? (identify which one and replace it) or was the fault in one of circuit boards? (identify which PCB failed and replace the board). Using Technician mode, select either ‗Main Self Test‘ to pass all the testable options, or select ‗Manual Test‘ to test 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.
2. Fault with syringe or administration set
- Check that correct syringe was used. Is the syringe on the list of approved syringes? - Is the administration set occluded?
3. Pump failure
Perform Main Self-test from Tech menu. See page 21
4. Mechanical failure
Change the defective part
5. Electronic failure
Change the relevant PCB
6. Failure of sensors: Syringe detection, sensors 1-3.
Replace the sensor module.
Page 11 of 107
Service Process Flow Chart Pump returned for service or repair
Power up the pump, note serial number & software version & access Technician menu
Log receipt, pump serial number & physical appearance (i.e. damage, signs of tampering)
Check history events and note the type & frequency of alarms / alerts. Check the IV-SET and syringe type that was used. Note serial number.
Does device pass all tests on the Operational Checklist?
Perform all tests in the Operational Checklist
YES
Check evenl tol for alarms and
NO Recalibrate, if any repairs or disassembly was performed on pump.
Troubleshoot Check evenl tol for alarms Repair and
Check evenl tol for alarms and Record that the pump has passed service. Clean & return to customer
Page 12 of 107
Service Information While under warranty, the device must not be opened by unauthorized personnel. The unit must be packed in its original packing, or in another container that will provide adequate protection during shipment. When calling the manufacturer, please be prepared to provide the serial number of the device and the service cause. In order to assure efficient service, always receive a Return Material Authorization Number (RMA) before you send a device to the Manufacturer for service.
Failure Identification Specific errors, which may occur in the operation of T34L Syringe pump, and the remedy for each problem are presented in the Troubleshooting section on page 65. Through the INFO mode, technicians can display the pump‘s history to help identify the cause for failure and its nature. Use the arrow keys to scroll through the last 512 events in the event log. The events are displayed from the most recent to the least current. Press the INFO key to display the full details of all data relevant to the displayed event.
Page 13 of 107
T34L Syringe Pump Default Settings The pump is programmed with a number of default parameters that can be changed using ‗Change Set Up‘ (and if applicable to the specific version, ‗Rate‘ setting) from the Info menu, and using the Technician menu. Changing these default parameters requires using access codes. Some default parameters may be software dependant. Whenever a software dependent parameter is indicated, the applicable range of software versions will be indicated. Generally, the software version sequence is indicated by the software numbers. For example, software version NCAT010110 should be the first version change (01) accepted on January (01) year 2010 (10). The T34L manufacturer should be referred to on any doubt regarding the applicable software version(s). PARAMETER
PURPOSE
Default
RANGE
Info Menu, accessed by pressing the INFO key. The display will show Info Menu and allow selection of the following parameters: Battery Level
Current battery level
Empty >> Full - %
Exit
Exit the Info Mode
Press YES/START key
Event Log
Last 512 events
Press Info for full disclosure
Rate Setting
In case the pump is set Volume over Rate*. Using this setting the rate can be locked.
Change Set up
access code ‗5‘
On software version LCATBOL3 and upwards
Can be modified when necessary
Change default parameters
Enter access code
Change Setup mode, access with code 99 Set Time & Date
Ensures all events in log are correctly date and time stamped.
FF Key Operation
Limits the forward movement of actuator caused by pressing the FF key during syringe loading
*
day, month, year, hours, minutes
0.1 – 100mm (out of total 2mm
Applicable to certain software versions, not to all.
Page 14 of 107
~ 106 mm travel)
PARAMETER
PURPOSE
Backlight Duration
Limits backlight duration to help preserve battery life
Info Duration
Limits the length of time the Info screen is displayed
Operation LED Titration Option On/Off
Default
RANGE
5 sec
0 – 60secs up to ON
5 sec
1 – 20secs.
Turns off the green flashing operation LED to preserve battery life
32 sec.
Disable, 2, 4, 8, 16, 32, 64sec
Allows user to change the operation rate during program .
Off
In case default duration is set to zero
*Bolus Maximum Volume
*availability depends on pump version. Allows setting the bolus max. volume.
Default Duration
When a new program is confirmed Pump resets to this default (setting to zero skips duration step during programming). When Program Lock ON (see below) cannot be set 24 Hours to zero.
00:01 to 99:00 hours
Occlusion Pressure
setting at which occlusion alarm will activate
540mmHg
100 – 1500mmHg
KVO Operation Rate
Activates Keep Vein Open infusion at End of Infusion
Disabled
Enabled/Disabled
Program Lock
Prevents alteration of either duration or rate during set up (with Program Lock ON Default Duration cannot be set to zero)
ON
ON/OFF
Exit
Enables user to exit Set up mode
Technician Mode, access with code 123 Serial Number / Production Date
Pump serial number and production date pump . (Week No., Month, and Year.)
Main Self-test
Automatically sequences through the following tests. Keypad, Display,
Page 15 of 107
PARAMETER
PURPOSE
Default
RANGE
Acoustic Alarm, Syringe Sensors, Diameter, Power Voltage, Manual Tests
Allows manual selection of the above tests
Syringe Set Up
Add or Delete syringes from the default list
Pressure Calibration
Pressure Calibration routine using the calibrated force gauges
See Pressure Calibration
Factory Press. Test
Test routine to fine tune the pressure calibrations, using a 5ml and 50ml syringe.
See Pressure Calibration
Pressure Test
Test routine to ensure pressure calibration is within specifications
Syringe Travel
Sets up the Volume sensing system by ensuring the CPU knows the position of the actuator
See Syringe Travel Calibration in this manual
Sets up the syringe recognition system.
See Diameter Calibration in this manual is for 2 points 8 mm and 30 mm in the newer versions, starting from LCATBOL4 , Software requires 3 calibration points.
Diameter Calibration
Syringe dead space
See ADDING/DELETING a Syringe procedure.
11 mm
Volume Test
Can be set to any volume at any flow rate, the Test is done by visual comparison between actual volume in the syringe and volume displayed on the pump screen.
Factory Settings
Reset all settings to default. Number of hours in use
Can be reset by pressing the NO key
Service Interval
Warning can be set when a preset number of operating hours has been reached
0 – 50000 hrs
Access Codes
Setting the three access codes of the pump for Technician, Change Set up, and Rate (defaults: 123, 99, 5 respectively).
The codes can be changed by the user.
Operating Hours
Purge Vol.
Reduce the start up time
Maximum Rate
Maximum flow rate the pump will operate at.
0.2 ml
0 – 0.5 ml (from software version LCATBOL3 the maximum purge volume was increased to 2 ml.
5ml/h
0.05 – 650ml/h
Page 16 of 107
Access Code List The T34L Syringe pump has three access codes and a Key lock feature to prevent tampering with settings and to control user access to authorized personnel only. Service technicians need to be familiar with these codes in order to access all areas of the pump for servicing and repairs. Code '99'
Access to pump ―Change set up‖ options, Allows locking program parameters.
Code '123'
Allows authorized technicians to access the Technician testing and service menu.
Code ‗5‘
Allows authorized personnel to change the Rate Setting via the Info Menu.
Key lock
Enables users to lock all keys except the INFO and Stop keys, to prevent tampering with the pump.
NOTE: The above mentioned codes are default numbers, and can be changed via Technician mode, under Access Codes, whenever required. NOTE:
Locking The T34L Syringe pump provides three types of locking:
Keypad Locking
Program Locking
Maximal Rate Locking
Keypad Locking During operation all keys are disabled excluding the STOP/NO and the INFO key. During programming all keys are disabled excluding the START/YES and the INFO key. To lock the keypad: Press and hold the INFO key until the keypad lock bar graph Keypad Lock is filled and a beep is heard. The beep indicates that locking is turned ON. OFF
ON
To unlock the keypad: Press and hold the INFO key until the keypad lock bar graph is depleted and a beep is heard. The beep indicates that locking is turned OFF.
Page 17 of 107
Keypad Lock
OFF
ON
Program Locking This feature enables the operator to lock out the setting keys, so that entered parameters, or set programs cannot be changed once they are set. This option is important as locking the program prevents user tampering with the pump parameters. For example, with children users there is danger that the child might play with the pump and unknowingly change the program; or for home-care patients who need to daily repeat the same program. To lock or unlock the program: 1
Press the INFO key twice.
2
Use the arrow keys to scroll to ‗Change Set up‘. Press YES/START to select this option.
Info Menu
Change Set up Select ↑↓, Press YES
3
The access code for ‗Change Set up‘ is 99. Use the arrow keys to set this code. Press YES/START to enter.
Enter Set up Code
99 Change ↑↓, Press YES
4
Use the arrow keys to scroll to ‗Program Lock‘. Press YES/START to select this option.
Change Set up
Program Lock Select ↑↓, Press YES
5
To lock: The default setting is OFF. Use the arrow keys to change the setting to ON. To unlock: If the program lock was ON, use the arrow keys to change to OFF and unlock.
Program Lock
OFF Select ↑↓, Press YES
NOTE: For program locking when the pump is set to Volume over Rate, press the INFO key while the program is on setting mode or stop mode, scroll to the ‗Rate‘ option and set the required rate to lock in. NOTE: Not available on all versions.
Maximal Rate Locking This feature enables the operator to set a maximal infusion rate for the pump. The program rate can then be adjusted only up to a preset limit. Maximum Rate locking 1
Enter Technician Mode by pressing INFO key and the power ON/OFF key down simultaneously until the software version is displayed and then releasing the ON/OFF key. After a few seconds the access code prompt will appear.
Page 18 of 107
2
Using the arrow keys, set code 123 and confirm by pressing the YES/START key.
Enter Tech Code 123 Change ↑↓, Press YES
3
4
Use the arrow keys to scroll to ‗Maximum Rate‘. Press YES/START to select this option. The pump will display the default maximum rate; use the arrow keys to change the maximum rate setting. Press YES/START to confirm and to exit. Press NO to exit without saving changes in the rate setting.
Technician Options: Maximum Rate Select ↑↓, Press YES Maximum Rate
5ml/h Change ↑↓, Press YES
Operational Checklist and Calibration Tests Introduction The Operational Checklist and Performance Acceptance Test detailed in this section determines if the device is operating correctly. The Operational Checklist and Performance Acceptance Test should be carried out before any service work is performed. If the device fails any test in the checklist, the fault must be recorded and corrected prior to placing the device back into clinical use. Any test failures should be analyzed using the troubleshooting procedure that follows to determine service action. After all service is completed, the Operational Checklist and Performance Acceptance Test should be repeated and the device should be re-calibrated if required. If the returned device is a complaint, the device should be tested with any associated products (i.e. sets, etc). Devices subject to complaint evaluation should be tested to try to duplicate the customer‘s complaint. Once the complaint evaluation with the associated product has been completed the device should be retested without the associated product in the normal service process. If the problem cannot be resolved, withdraw the pump from user service and troubleshoot according to the troubleshooting table (p. 65), or return the device to the manufacturer for service. 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. The following test equipment is required to perform the tests in the operational checklist:
Force gauge
Calibrated stop watch
Leakage Current testing device (for safety tests)
Connecting flat cable between the front and rear housing will allow the technician to test the pump while the front and rear housing are separated.
Page 19 of 107
Checklist Test No.
Description
Pass criteria
1. Main Self Test (in technician mode to access with code 123) a
Keypad test - Tests operation of all keypad keys
Test passes if all keys work
b
Display Test - Tests all pixels back light
Test passes if all backlight pixels work
c
Acoustic alarm test - Tests volume of alarm
Test passes if alarm volume can be heard from 20 feet
d
Syringe Sensors Test (load syringe, remove syringe)
Loaded syringe detected, PASS displayed. Removal of syringe detected, PASS displayed.
e
Syringe Diameter Test
Test correct detection of syringe diameter
f
Syringe Travel Test
PASS displayed when successful auto travel completed.
DC Voltage
Between 9-10V ±0.3V
Power Voltage Test
reading to be between 7 to 8.4 v
g
To be compared with the actual voltage on the battery (to measure on the DC connector)
Should not be more than 0.2V.
2. Battery Operation Test 1. When a fully charged battery is loaded in the pump, under the Info mode the pump should detect 100%.
95%-100%
3. Restore Software Default Settings In case the Syringe main PCB was replaced, verify that the same software version and settings was restored. See Appendix B for new software burning
Verify that the correct Macro are restored/
5. Volume Delivery (p. 22, p. 49) Load any syringe into the pump. Verify the correct syringe was detected. Perform visual comparison between actual volumes in syringe and the volume detected by the pump.(if fails, let the pump complete preloading and test again).
Page 20 of 107
Volume delivery test passes if volume delivered is setting +/2%.