T34 Service Manual Rev 04

Contents 1 INTRODUCTION

5

Overview Technical overview Service overview Technical specification Safety Document notices

7 8 10 11 12 13

2 Set Up And Testing

16

Services information failure identification pre-service checklist Service process flow chart Default settings Change Set Up Technician menu enabling and disabling a syringe type Operational checklist and calibration tests Maintenance preventive maintenance & functional test procedures Calibrations Battery operation User Mode functional testing Sample service sheet

3 Pump Assembly Introduction pump assembly and disassembly

4 Software

17 17 18 20 21 25 26 28 29 30 31 35 39 40 45

46 47 48

62

BodyComm communication software list of events and alarms

63 75

5 Troubleshooting and Manufacturer Notices

76

Troubleshooting frequently asked questions

6 Appendices assembly overview

77 82

84 85 T34 Service Manual REV.04

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front assembly Motor block assembly and electronics Rear case and electronics Rear and front housing labels and screw locations front housing assembly Block assembly actuator assembly Rear assembly pump assembly Main PCB wiring schematic Main syringe PCB encoder PCB wiring schematic Main PCB layout encoder PCB layout T34 motor PCB Motor PCB layout Rear PCB Rear PCB layout Bills of material Software versions device history

86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 107

Manufacturer

Distributor (UK & Ireland)

Caesarea Medical Electronics 16 Shacham street Industrial Park Caesarea North P.O.Box 3009 Caesarea 3088900 E: [email protected] W: www.cme-infusion.com

CME Medical UK Limited Kincraig Business Park Kincraig Rd, Blackpool Lancashire FY2 0PJ Tel 01253 894646 Fax 01253 896648 [email protected]

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1 Introduction

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Introduction to the T34 3 1

2

4

15

14

13

6

12 8

7

1

Syringe holder arm (detects syringe size 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

Actuator (drives the syringe plunger to deliver syringe contents)

5

Instructions for infusion set up

6

Operation LED (green when infusing, red when stop or alarm. Can be disabled)

7

On/Off key (turns the pump on and enables the user to turn it off from stop)

8

Back (reverse) key (moves actuator backward when no syringe present)

9

FF (forward) key (moves actuator forward when no syringe loaded)

10 No/Stop key (takes user back a step during programming; stops pump) 11 Yes/Start key (confirms choices during programming) 12 Down arrow key (decreases infusion parameters; scrolls between options) 13 Up arrow key (increases infusion parameters during programming and use; scrolls between options) 14 Info key (shows event log, volume infused, volume to be infused and battery status; long press will lock/unlock keypad) 15 Graphic LCD (128 pixels x 32 pixels with programmable backlight duration; when any key is pressed the backlight turns on) T34 Service Manual REV.04

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Overview The T34 is a lightweight, battery-powered infusion pump, designed for ambulatory use in a hospital or homecare setting. It can deliver indicated medications via any common infusion route, including intravenous and subcutaneous. It is suitable for adult or pediatric use. The T34 has a three-point syringe detection, by which it can identify all commonly used syringe brands. It may also be programmed to detect other syringes. This feature enables the pump to calculate the syringe volume and, depending on the mode of operation, to deliver the contents over a specified duration or at a specified rate, in milliliters per hour, therefore minimizing the risk of programming errors. Sensors activate an alarm if the syringe is removed or displaced during infusion. Other safety features include access-code protection, keypad lock and event log.

MODES OF OPERATION The pump can be configured and locked to one of three modes of operation (the default mode of operation is Lock On). The mode-of-operation options are: lock on: Delivers the contents of the syringe over a fixed, pre-programmed duration (the pump default is 24 hours). The pump automatically calculates the ml/h infusion rate for the confirmed deliverable volume. lock off: This mode permits the user to set a custom duration for delivery of the infusion. The pump automatically calculates the ml/h infusion rate based on the selected duration of delivery and the confirmed deliverable volume. rate mode: Permits the user to set the required flow rate, in ml/h. The pump detects the volume of the syringe and calculates the duration of the infusion accordingly.

INTENDED USE The T34 syringe pump is designed for the infusion of medications or fluids that require continuous or intermittent delivery at precisely controlled infusion rates. It can deliver these medications through all clinically acceptable routes of administration, including intravenous; subcutaneous; percutaneous; epidural, in close proximity to nerves; and directly into an intra-operative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, chemotherapeutic agents, or general fluids therapy. It is suitable for use in both the hospital and homecare environment.

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Technical overview Syringe pumps are ideal for low-volume applications where accuracy is important. A syringe pump is often called a piston pump, as the fluid is moved by the syringe piston. The accuracy of the pump is determined mainly by the syringe used, and to a much lesser extent is determined also by the accuracy of the pump itself. The driving mechanism is always a lead screw, rotated either by a stepper motor or by a permanent-magnet motor with a gearbox. The T34 uses a permanent-magnet motor, which can deliver the same torque as a stepper motor but from a much smaller unit, and because it draws much less current than a stepper motor of comparable rating. Both of these factors are significant in a pump for which size and battery life are important. When testing a syringe pump at low rates it is important to let the unit run long enough to take up the system backlash before attempting to measure volumetric accuracy. The T34 includes a Technician menu which speeds up this process: as the displacement rate is determined by the lead screw pitch and the rate of the optical shaft encoder pulses, the need to adjust the device is eliminated.

OCCLUSION DETECTION IN THE T34 To keep battery size down the T34 does not use a strain gauge to measure occlusion force; instead, the motor current is monitored by a linear amplifier. The resulting voltage is roughly proportional to force. While this system is not as accurate as a strain gauge in a bridge configuration, it is adequate for the intended application of the pump. The system specification for a nominal occlusion alarm of 540mmHg is 380mmHg - 700mmHg. Variations in friction of the syringe will affect the occlusion pressure, so it is important to use a new syringe when verifying performance. A syringe friction rapidly increases after only a few occlusion measurements.

MOTOR CONTROL IN The T34 Motor rotation is monitored by an optical shaft encoder and a rotating magnet. The microprocessor uses data from both to confirm the motor speed. The rotating magnet on the motor shaft operates a reed switch positioned just below the shaft end of the motor. A slotted disc on the end of the lead screw, together with an IR LED and photodiode, form a shaft encoder to monitor lead screw position. Two more reed switches, one at each end of the lead screw, slow the motor as the actuator approaches the end stop. The motor can be stopped, started or reversed by means of an H Bridge driving circuit. * With a large syringe size and a high occlusion setting the motor current can easily exceed 100mA, so it important that an alkaline battery is used. The zinc carbon type cannot provide the high current required as occlusion occurs.

* An H-bridge is an electronic circuit that enables a voltage to be applied across a load in either direction, to allow a DC motor to run forward and backward. H-bridges are available as integrated circuits, or they can be built from discrete components.

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As with most modern products, all functions are controlled by a microprocessor. The main crystal clock for the processor is checked against the RTC clock source to ensure correct timing; a watchdog timer is also employed to shut down the motor and keypad in the event that the micro program stops executing. The motor speed is locked via the encoder to the checked crystal source and confirmed by the motor reed switch pulses. There is no provision for speed adjustment as there is no need for it. On power, up the microprocessor carries out a self-test on most subsystems, including the motor and encoders.

PERFORMANCE VERIFICATION There are a number of items that the microprocessor cannot test without human intervention. These are the display and LEDs, acoustic alarm, keypad matrix, syringe size potentiometer, collar micro switch, plunger micro switch and accuracy of occlusion detection. These items need to be manually tested, by entering Technician Mode and scrolling to the Main Self-Test Menu, where several automated test routines allow rapid confirmation of all system alarms and functions.

Collar

Plunger

Syringe size

Simplified

Main xtal

Ceramic resonator

RH end LH end

Dog

Matrix

H Bridge

Only three actual physical measurements need be made: •

Volume

•

Occlusion pressure

•

Syringe barrel clamp arm

All of these measurements can be made using inbuilt test routines accessed via the Technician Mode menu. Non-technical staff who do not have the Technician Mode access code will need to carry out these tests in real time. T34 Service Manual REV.04

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Service overview This manual provides instructions for the service of the T34 syringe pump and its software. It is intended to support CME Medical-authorized service technicians.

The following requirements and conditions apply when performing service on CME Medical products. Failure to follow these instructions will invalidate the warranty and may also create unacceptable risk: •

Service of T34 syringe pumps and accessories may only be performed by CME Medical authorized service personnel. Service may only be performed with the recommended equipment and CME Medical approved parts.

•

Clinical personnel, patients, and other users are advised to return syringe pumps to an authorized service centre for service.

•

Refer to the operation manual for pump operation instructions, cautions and warnings.

•

Refer to the BodyComm operations manual for BodyComm operation instructions.

•

Document the service performed in accordance with the service provider’s maintenance test procedures.

CME Medical recommends that the T34 is serviced every 12 months. The unit can be programmed via the pump or the BodyComm software to alert the user when it is due for service or calibration. When the programmed time is reached the message below will be displayed each time the device is powered up (the T34 is not disabled but can continue to be used after the alert has been triggered). The unit can only be reset after it has been fully serviced. Please refer to the procedure after User Mode Functional Testing (Normal Operation Mode) in this service manual.

Calibration Due Message displayed:

Send for service Press YES - continue

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T34 technical specifications Device type

Syringe pump with motor-driven linear actuator, pulsed motion (540 pulses per mm)

flow rate

0.05–10ml/h in 0.01ml increments, 10–650ml/h in 1ml increments

actuator stroke

67mm available

Syringe sizes

2–50ml (most commonly used)

System accuracy

±5%

Occlusion pressure

Configurable to 150–1500mmHg (10mmHg increments). Maximum actuator force 50N (5kgf)

Battery

9V, primary alkaline, IEC 6LR61

Indicators

Four-line LCD display (128 x 32 pixel); dual-colour LED

alarms

Occlusion/ syringe empty

Pump paused too long

End program

Low battery

End battery

Syringe displaced

Pump unattended Dimensions

169 x 53 x 23mm

Classification

Type CF Equipment (degree of protection against electrical shock)

housing

ABS (fire retardant) IPX3

Weight

210g (without battery)

electrical safety

Complies with EN 60601-1 (Medical Electrical Equipment Safety); IEC 60601-2-24 (Infusion Pumps and Controllers); IEC 62304 (Software life cycle processes)

Standards

Manufactured in accordance with ISO 13485:2016. CE Marked in accordance with Medical Devices Directive 93/42/EEC

electromagnetic compatibility (EMC)

In compliance with EN 60601-1 (Safety) and IEC 60601-1-2

Transportation and storage conditions

Temperature

-25°C to +50°C (-13°F to +122°F)

Humidity

5% to 100% RH, non-condensing

Air pressure

48kPa to 110kPa

(EMC)

Operating conditions Performance specifications may not be met if operated outside of the following conditions: Temperature

+15°C to +45°C (+59°F to +113°F)

Humidity

20% to 85% RH at +40°C, non-condensing

Air pressure

70kPa to 110kPa

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Safety SYSTEM SYMBOLS The following symbols are used on the T34 syringe pump and its 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 Do not dispose of battery in municipal waste. Symbol indicates separate collection of battery is required

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

SN

Serial number

Expiry date of disposable part

6

Lot number

Sterile eo

Sterilized with ethylene oxide

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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 T34 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 T34 syringe pump.

note notes presented in this format highlight additional information or a tip that will help you operate the t34 syringe pump

WRNINGS To avoid possible personal injury or loss of life, observe the following: Read the entire Operation Manual before using the pump. The text includes important precautions that should be observed. The T34 syringe brand detection is based on the physical dimensions of syringes used in the UK during 2006. Some branded syringes are made at multiple sites, however, and may in practice show slight variations. If the T34 does not correctly identify the syringe DO NOT use that syringe, and please promptly notify the T34 manufacturer. Use a visual check to ensure that the volume in the syringe matches the volume indicated on the T34 screen. Before starting an infusion check that all parameters are set, and especially ensure that calculated parameters are correct. Visually check that the volume in the syringe matches the volume shown on the pump screen and the calculated rate. In the event that the default duration is set to zero, fix the required rate. The maximum volume that may be infused under single-fault conditions depends on syringe size and brand and is equivalent to three 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. The drugs must be administered in accordance with the manufacturer’s instructions. Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

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The T34 syringe pump should be operated within a temperature range of +5°C (41°F) to +45°C (113°F) 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 the manufacturer. Dropping the T34 syringe pump could cause damage to components. If the pump is dropped, return it for inspection by qualified service personnel. Use aseptic technique. Patient infection may result from the use of nonsterile components. Maintain the sterility of all disposable components and do not re-use single use IV sets or syringes. Make sure that only syringe brands that are recognized by the software are used. When starting a new infusion allow the pump to complete the preloading procedure, as this procedure will assure the correct calculation of the volume in the syringe.

CAUTIONS To avoid possible damage to the equipment, observe the following: Do not store the pump with the battery installed.

Should any liquids be spilled on the pump, clean these immediately using a damp cloth or sponge. A mild detergent may be used. Do not use Xylene, acetone or any similar solvent as these could damage the pump. Wipe thoroughly with a dry cloth. Do not immerse the T34 in any type of liquid, as this could damage the internal components. Battery damage could occur if the pump is left in a temperature warmer than 50°C.

ELECTRICAL SAFETY COMPLIANCE The T34 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)

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ELECTROMAGNRTIC COMPATIBILITY (EMC) •

IEC 60601-1-2 (Electromagnetic Compatibility)

ALARMS Alarm conditions Should the pump detect a problem an alarm will be activated, and the following will occur: •

An alarm message appears on the display, stating the cause of the alarm and indicating instructions for continued use. The operation LED will light red

•

An alarm sounds

•

If the unit is infusing the pump will stop the infusion when an alarm is activated.

Alarm types •

Occlusion / Syringe Empty

•

Pump Paused Too Long

•

End Program

•

Low Battery

•

End Battery

•

Syringe Displaced

•

System Error

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2 Set Up and Testing

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Service information While under warranty or a service agreement, the T34 syringe pump should only be opened by CME Medical service personnel or on the instruction and agreement of the company. In the event this condition is breached the warranty or contract will be invalidated. Unless otherwise agreed, the customer is responsible for all shipping costs when returning the pump for service, including times when the pump is under warranty. The unit must be packed in its original packaging or otherwise in a container that will provide adequate protection during shipping. To assure its prompt service and return, the CME Medical service department must be notified on 01253 894646 before any unit is sent for repair. Reference should be made to any relevant warranty or service agreement or an order number provided, and the serial number of the device should also be provided. A brief written description of the problem or reason for return should be included with the pump.

failure identification To help identify the conditions and settings at the time of pump failure, users can view a log of the last 512 actions undertaken by the pump. This Event Log is accessible via Change Set Up on the main menu. The events are displayed in order, beginning with the most recent. The user can scroll through the list by using the Arrow Up key and can select a specific event to display further information on the pump settings at the time of that event. This information may help to determine the nature of the failure and could be useful in troubleshooting its cause or excluding user error.

SYSTEM FAILURE If the device fails, the unit will be inoperative, and the following message will be displayed:

System Error Press and hold INFO for details Pressing the Info key will display the error on the device, for example, as follows:

ERROR Start Up Mot Mov Fail If the problem persists send the pump for service.

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pre-service checklist Before performing any service procedure, the following checks and procedures should be undertaken.

SERVICE PERSONNEL Service personnel must have training and certification from either the manufacturer or from trainers who are fully authorized by the manufacturer. All service personnel must have the recommended equipment and authorized spare parts on hand to perform the required maintenance procedures or repairs.

DISINFECTION All pumps must be properly disinfected according to the instructions in the user manual.

CUSTOMER INFORMATION The document record for each pump should be examined, and it should be confirmed that the pump bears the correct log receipt and serial number. The pump should also be checked for damage or signs of tampering.

EVENT LOG In cases where a problem has been reported, check the History events to define the frequency and nature of the complaint, and note the program and calibration settings at the times of each recorded event. Undertake a manual review of pump settings and record the syringe pump settings before beginning service of the unit. Access the Technician menu and press and hold the Info key and Power button; keeping the Info button pressed release the Power button to display the software version number. This will be followed by the prompt to enter the Technician Code. Enter the code ‘123’ and press Yes/Start to confirm. Scroll to and perform Main Self-Test. Record any failures or issues identified during the test.

SERVICE DECISIONROUTE When a T34 syringe pump is returned for service, always ask for a full description of the reasons why the service is being requested. If possible and appropriate, ask for the return also of the administration set in use at the time. Be mindful of the following factors as part of the service/repair procedure: Cross-reference the user’s reasons for requesting the service with the event log. Has the user operated the pump correctly? Cross-reference their report with the Operations Manual to

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ensure that the steps taken prior to the alarm did not in fact cause the alarm or trigger an error. Was the fault in one of the pump sensors (identify which one and replace it), or was the fault in one of the circuit boards (identify which PCB failed and replace the board)? Access Technician mode and select either Main Self-Test to run all of the testable options or select Manual Test to test a specific function.

Possible issues

corrective action

User error

Refer issues back to department lead and suggest training/ alerting all users, to prevent the same error being repeated

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?

Pump failure

Perform Main Self-Test from Tech menu

Mechanical failure

Change the defective part

Electronic failure

Change the relevant PCB

Failure of sensors: Syringe detection, sensors 1–3

Replace the sensor module

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Service process flow chart

Log receipt, pump serial number and physical or signs of tampering)

IV-SET and syringe type that was used.

operational checklist?

Troubleshoot the pump

Repair

passed service Clean and return to customer

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Default settings The T34 pump is programmed with a number of default parameters that can be changed using Change Set Up and, if applicable to the specific version, the Rate setting. These are accessible via the Info menu and Technician menu. Changing them requires the use of an access code. Some default parameters may be software-dependent. Where a software-dependent parameter is indicated, the applicable range of software versions will also be shown. Generally, the software version sequence is indicated by the software numbers. For example, software version NCAT010110 refers to the first version change (01) accepted on January (01) 2010 (10).

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 (shown as percentage)

Exit

Exit the Info Mode

Press Yes/Start key

Event Log

Last 512 events

Press Info for full disclosure

Rate Setting

Enables the flow rate to be locked in cases where the pump setting gives priority to volume over rate

Change Set Up

Change default parameters

Access code ‘5’

On software version NCAT11009C and upwards Enter access code

change set up mode (access with code 99) Set Time and Date

Ensures all events in log are correctly date and time stamped

Day, month, year; hours, minutes

FF Key Operation

Limits the forward movement of the actuator that results from pressing the FF key during syringe loading

5mm

0.1–100mm

Backlight Duration

Limits backlight duration, to help preserve battery life

5 seconds

0–60 seconds

Info Duration

Limits the length of time the Info screen is displayed

5 seconds

1–20 seconds

Operation LED

Turns off the green flashing operation LED to preserve battery life

32 seconds Disable; 2, 4, 8, 16, 32, and 64 seconds

Titration Option (on/off)

Allows user to change the operation rate during program

Off

In case default duration is set to zero

Default Duration

When a new program is confirmed the pump resets to this default (setting to zero skips the duration step during programming). When Program Lock is on (see below) this cannot be set to zero

24 Hours

00:01 to 99:00 hours

Occlusion Pressure

Setting at which occlusion alarm will activate

720mmHg 100–1,500mmHg

KVO Operation Rate Activates Keep Vein Open at end of infusion

Disabled

Enabled/disabled

Program Lock

Prevents alteration of duration or rate during Set Up (with Program Lock on, the default duration cannot be set to zero)

On

On/off

Exit

Enables user to exit Set Up mode

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