T34 Syringe Pump Technical Service Manual (3rd ed) Rev. 00

This manual has been prepared for use by qualified service personnel only. Caesarea Medical Electronics Ltd. (CME) cannot accept any liability for any breakdown or deterioration in performance of parts or equipment resulting from unauthorized repair or modification.

The information in this document is subject to change and does not represent a commitment on the part of BD to provide additional services or enhancements. The screens and images illustrated in this document are for reference purposes only and might be different than the screens displayed on your pump and pc. Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area.

0344 T34™ is a registered trademarks of Caesarea Medical Electronics Ltd. or one of its subsidiaries. All other trademarks belong to their respective owners.

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Table of Contents

Table of Contents 1

General Information ...5 Overview ... 5 Introduction to the T34™ Syringe Pump ... 7 Technical Overview ... 8 Warnings and Cautions ... 10 Safety ... 12 Alarms ... 13

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Configuration and Calibration ... 16 Batteries ... 16 Locking ... 17 Configuration and Calibration ... 18 Communication (Between PC and Syringe Pump) via BodyComm™ ... 25 Event Log ... 25

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Preventative Maintenance... 26 Introduction ... 26 Recommended Cleaning and Storage ... 26 Routine Preventive Maintenance ... 26 Tools and Test Equipment ... 27 Performance Verification and Calibration Tests ... 28 Visual Inspection... 34 Service Decision Route ... 35 Service Process Flow Chart ... 36

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Troubleshooting... 38 List of Events and Alarms ... 44 Failure Identification ... 45

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Corrective Maintenance ... 46 Introduction ... 46 Access Code List ... 46 Software Burning Instructions ... 47 Disassembly ... 54 Restore Software Default Settings ... 68 T34™ Syringe Pump Default Settings ... 70

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Service Center Recommended Part List ... 74

A

PVP – T34™ ... 80

B

Drawings ... 82 Front Assembly ... 82 Block Assembly ... 82 Actuator Assembly ... 83 Rear Assembly ... 83 Pump Assembly ... 84

C

Limited Warranty ... 86

D

Specifications ... 88

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Table of Contents

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1 General Information 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 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 three-level access-code protection, keypad lock, event log and full alarm protection.

Figure 1: T34™ Syringe Pump in lock box

Modes of Operation The T34™ 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, preprogrammed duration (the pump default is 24 hours). The pump automatically calculates the ml/hr 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/hr 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/hr. The pump detects the volume of the syringe and calculates the duration of the infusion accordingly.

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General Information

Intended Use The T34™ syringe pump is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, Immunoglobulins, biosimilar, chemotherapeutic agents and general fluids therapy in hospital and homecare environments. Contraindications: Infusion of blood and blood products Infusion of insulin Infusion of critical medications whose stoppage or interruption could cause serious injury or death Use in ambulatory regimens by patients who do not possess the mental, physical, or emotional capability to self-administer their therapy; or who are not under the care of a responsible individual

Purpose of This Manual This manual provides instructions for servicing the T34™ syringe pump and its software. The following requirements and conditions apply while servicing CME products. Failure to follow these instructions invalidates the warranty and causes unacceptable risks: Servicing T34™ syringe pumps and accessories must only be performed by CME-authorized service personnel. Service must only be performed using the recommended equipment and CME-approved parts. This manual is intended to support CME-authorized service technicians who are servicing the T34™ syringe pump. Clinical personnel, patients and other users are advised to return syringe pumps to an authorized service center for service. Refer to the T34™ Syringe Pump DFU for pump operation instructions, cautions and warnings. Refer to the BodyComm™ DFU for BodyComm™ software operation instructions. Document the service performed in accordance with the service provider’s prevailing procedures.

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General Information

Introduction to the T34™ Syringe Pump 1 2

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Figure 2: T34™ Syringe Pump 1

Syringe Holder Arm: Detects syringe size/width of barrel based on barrel diameter.

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Syringe Collar Sensor: Detects that the syringe collar is loaded correctly.

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Operation LED: o

Blinking green while infusing.

o

Yellow; blinking – medium priority alarm. Continuous – low priority alarm

o

Red; high priority alarm and pump stops.

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Plunger Sensor: Detects that the syringe plunger is loaded correctly.

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Actuator: Drives the syringe plunger in order to deliver syringe contents.

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Graphic LCD Display:

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o

128 pixels x 32 pixels.

o

The backlight duration is configurable.

o

When any key is pressed, the backlight turns on.

Info Key: o

Shows the Event Log, Volume Infused, Volume to be Infused and battery status.

o

A long press locks/unlocks the keypad.

Up Arrow Key: o

Increases infusion parameters during programming/use.

o

Scrolls between options.

Down Arrow Key: o

Decreases infusion parameters during programming/use.

o

Scrolls between options.

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General Information

10 YES/START Key: Confirms selections during programming. 11 NO/STOP Key: Moves back one step during programming or stops the infusion. 12  (FF - Forward) Key: Moves the actuator forward when no syringe is loaded. 13  (BACK - Reverse) Key: Moves the actuator backward when no syringe is present. 14 ON/OFF Key: Turns the pump on or off while in the STOP state. 15 Instructions for infusion setup.

Technical Overview Syringe pumps are ideal for low-volume applications where accuracy is important. A syringe pump is often called a piston pump or syringe driver, as the fluid is moved by the syringe piston. The accuracy of the pump is determined in conjunction with the syringe used, and should only be used with syringes approved by the pump manufacturer. The driving mechanism is a lead screw, rotated either by a stepper motor or by a permanentmagnet 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, as 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™ Syringe Pump includes a Technician menu, which speeds up this process. Because the displacement rate is determined by the lead screw pitch and the rate of the optical shaft encoder pulses as well as the syringe data in the pump database, the need to adjust the device is eliminated.

Occlusion Detection in the T34™ Syringe Pump To minimize the battery size in the T34™ Syringe Pump, the T34™ pump 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 540 mmHg is ±160 mmHg (380 mmHg – 700 mmHg). Variations in friction of the syringe affect the occlusion pressure. Therefore, 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™ Syringe Pump 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 the 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 (also referred to as the End of Travel).

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General Information

The motor can be stopped, started or reversed by means of an H-Bridge driving circuit.1 With a large syringe size and a high occlusion setting, the motor current can easily exceed 100 mA, so it is important that an alkaline battery be used. A zinc carbon-type battery cannot provide the high current required as occlusion occurs. 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 must 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.

Figure 3: T34™ Syringe Pump Block Diagram Only three actual physical measurements need to be made: Volume Occlusion pressure Syringe barrel clamp arm

1 An H-Bridge is an electronic circuit that enables a voltage to be applied across a load in either direction, in order 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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General Information

All of these measurements can be made using built-in test routines that are accessed via the Technician menu.

Warnings and Cautions Document Notices Warning: Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand this manual and the T34™ Syringe Pump DFU, taking note of all warnings before operating or performing service on the T34™ Syringe Pump. Caution: Cautions advise you of circumstances that could result in damage to the device. Read and understand this manual and the T34™ Syringe Pump DFU, taking note of all cautions before operating or performing service on the T34™ Syringe Pump. This pump contains static-sensitive components. Observe strict precautions for the protection of static-sensitive components when attempting to repair and service the pump. An explosion hazard exists if the pump is used in the presence of flammable anesthetics. Exercise care to locate the pump away from any such hazardous sources. Dangerous Voltage. An electrical shock hazard exists if the casing of the pump is opened or removed. Refer all servicing to qualified service personnel. If the pump is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified service personnel. Note: Indicates that the information that follows is additional important information or a tip to help you when operating or performing service on the T34™ Syringe Pump.

Warnings To avoid possible personal injury or death, observe the following warnings: Warning: Read the entire T34™ Syringe Pump DFU before using the pump, since the text includes important precautions. Warning: T34™ syringe brand detection is based on the physical dimensions of the syringes programmed into the pump database by the manufacturer. However, the same-brand syringes may be manufactured at different sites bearing small differences that are beyond the control of the T34™ manufacturer. Therefore, do not use the T34™ if the correct syringe brand is not detected and promptly notify the T34™ manufacturer. Always ensure that the visual volume in the syringe matches the actual volume on the T34™ display.

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General Information

Warning: Before starting an infusion, check that all parameters that are set, especially calculated parameters, are correct. Visually check that the volume in the syringe matches the actual volume on the pump display and the calculated rate. In case the default duration is set to zero, apply the required rate of infusion. Warning: The maximum volume that may be infused under a SINGLE FAULT CONDITION is 1.6 ml in a large size syringe and varies based on syringe size and brand. Warning: A kinked or occluded infusion line may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the line is not kinked or occluded. Warning: 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. Warning: Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. Warning: The T34™ Syringe Pump should be operated within a temperature range of 5C (41F) to 45C (113F) and up to 85% humidity. Operating the pump at temperatures and/or humidity outside this range may affect accuracy. Warning: Unsafe operation may result from using inappropriate accessories. Only use accessories and options designed for this system and supplied by the manufacturer. Warning: Dropping the T34™ Syringe Pump could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel. Warning: Use an aseptic technique. Patient infection may result from the use of nonsterile components. Maintain sterility of all disposable components and do not re-use single-use infusion sets or syringes. Warning: Ensure that the syringe brands used (at the medical provider) are enabled in the software. All other syringes should be disabled. Warning: When starting a new program, allow the pump to perform a preloading procedure, as this procedure ensures correct detection of the volume in the syringe.

Cautions To avoid possible damage to the equipment, observe the following cautions: Caution: Do not store the pump with the battery in it. Caution: Xylene, acetone or similar solvents may 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. Caution: Immersing the T34™ Syringe Pump into liquid may cause damage to components. Do not immerse the pump into any type of liquid. Caution: Battery damage may occur if left in a temperature warmer than 50C.

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General Information

Safety System Symbols The following symbols are used on the T34™ Syringe Pump Infusion System 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. Refer to DFU: Read the entire DFU before using the pump. 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 the battery in municipal waste. Symbol indicates separate collection for battery is required.

IP22

Symbol for degree of protection against ingress of water and solid objects. Class II Medical Electrical Equipment providing double insulation for operator and patient safety. 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. Manufacture By. Serial Number. Expiry date (consumables). Lot number (consumables). Sterilized with Ethylene Oxide (applies to administration sets). Battery. Alternating current. Direct current. Reference number. Indicates the manufacturer's catalogue number so that the medical device can be identified. Indicates the acceptable upper and lower limits of atmospheric pressure (altitude). Indicates the acceptable upper and lower limits of relative humidity. Indicates the range of temperatures to which the medical device can safely be exposed. Indicates a medical device that should not be used if its packaging has been damaged or opened. Indicates the number of drops per millilitre.

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General Information

Electrical Safety and Standard Compliance The T34™ complies with the following standards: IEC 60601: Programmable Electrical Medical System IEC 60601-1, Ed. 3.1:2012: Medical Electrical Equipment Safety IEC 60601-1-8: 2006, +A1:2012: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-6, Ed. 3.1:2013: General requirements for basic safety and essential performance – Collateral Standard: Usability IEC 60601-1-11, Ed. 2.0: 2015: Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-2-24, Ed. 2.0:2014: Safety of Infusion Pumps and Controllers IEC 62304, Ed. 1.1: 2015: Medical device software - Software life cycle processes

Electromagnetic Compatibility (EMC) IEC 60601-1-2, Ed. 4.0:2014, : Electromagnetic Compatibility

Alarms Alarm Conditions At any time, when the pump detects a problem, an alarm is activated and the following occurs: The infusion stops. An audible alarm sounds. An alarm message appears on the display, stating the cause of the alarm and indicates instructions for continued use. The operation LED lights red or yellow depending on alarm priority.

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General Information

Description

Alarm Type

Audio Signal as per 60601-1-8

Visual Signal as per 60601-1-8 Operational LED

Down Occlusion End Battery End Of Infusion Syringe displaced during infusion

High Priority alarm Requires immediate user response

High Priority Volume=~ 58 dBA

RED Flashing visual Operation LED Flashes RED.

Restart Pump Switch off & On ERROR XX End Of Infusion (Keep Vein Open)

Pump Paused too long Low Battery

Medium Priority Alarm Requires prompt user response

Low Priority Alarm Requires user awareness

3 tones Volume=~58 dBA

YELLOW flashing signal Operation LED Flashes Yellow Yellow solid visual

Low Priority 3 tones Volume=~ 55 dBA

Near End

Operation LED is solid Yellow (Not flashing)

Bolus Started/Completed Keypad Lock/Unlock Syringe plunger hit the limit Syringe loaded Purge started/End Power On/Off

Informational signal Provides information that may, or may not requires action from clinicians

1 or 2 pulses

No visual

Infusion started/ resumed/ Stopped by user KVO stopped by user Service interval alert

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General Information

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2 Configuration and Calibration Batteries The T34™ has a lithium CR1220 3V battery on the motor PCB, which keeps the time and date data on the event log. The battery should be replaced every four years, and should be checked annually. If the battery is found to be rated at less than 3V, it should be replaced.

Battery Operation The T34™ Syringe Pump operates on battery power. Note: Only use 9 V alkaline, IEC 6LR61 type. Do not use batteries marked 6LP3 with the T34™. 6LP3 batteries can cause issues with the operation of the syringe driver, as the physical construction and internal resistance of this type of battery are different to the 6LR61 battery. Issues arising from use of the 6LP3 battery can include End Battery messages during Pre-Load, volume test fails, pressure test/calibration issues and reduced amount of infusions from a battery. Note: Verify that the battery is in good condition by pressing the INFO key during program setup or operation. Press the INFO key to display the battery status. There are two battery alarm conditions: The pump warns that the battery is low before the End Battery alarm activates.

Low Battery

When the battery is depleted, the pump ceases operation and the End Battery alarm is activated: If the battery runs out, End Battery appears on the display. The pump stops the infusion. The pump may shut down immediately.

End Battery

From the End Battery state, the user cannot restart the pump until the battery is replaced with a new one.

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Configuration and Calibration

Locking The T34™ Syringe Pump provides three types of locking: Keypad Locking, below Program Locking, page 18 Maximum Rate Locking, page 18

Keypad Locking During operation, all keys are disabled except the STOP/NO and the INFO key. During programming, all keys are disabled except the START/YES and the INFO key. This feature enables the operator to lock the keypad. This option is important, as locking prevents users from tampering with the pump parameters.

To lock the keypad: Press and hold the INFO key until the keypad lock bar graph is filled and a beep is heard. The beep indicates that locking is turned 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. Some earlier software versions require code 99 to unlock the keypad.

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Configuration and Calibration

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 users from tampering with the pump parameters. This is especially important, for example, if there is the risk that a child may play with the pump and unknowingly change the program, or for home-care patients who need to repeat the same program daily.

To lock or unlock the program: 1

Press the INFO key.

2

Use the arrow keys to scroll to Change Setup. Press YES/START to select this option.

Info Menu Change Setup Select ↑↓, Press YES

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The access code for Change Setup is 99. Use the arrow keys to set this code. Press YES/START to enter.

Enter Setup Code 99 Change ↑↓, Press YES

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Use the arrow keys to scroll to Program Lock. Press YES/START to select this option.

Change Setup Program Lock Select ↑↓, Press YES

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To lock: The default setting is OFF. Use the arrow keys to change the setting to ON.

Program Lock OFF Select ↑↓, Press YES

To unlock: If the program lock was ON, use the arrow keys to change it to OFF and unlock.

Note: For program locking when the pump is set to Volume over Rate, press the INFO key while the program is in Setting mode or Stop mode, scroll to the Rate option and set the required rate to lock.

Maximum Rate Locking This feature enables the operator to set a maximum infusion rate for the pump. The program rate can then be adjusted only up to the preset limit.

To set Maximum Rate Locking: 1

Enter Technician mode, as described on page 19.

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Use the arrow keys to scroll to Maximum Rate. Press YES/START to select this option.

Technician Options: Maximum Rate Select ↑↓, Press YES

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The pump displays 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.

Maximum Rate 5ml/h Change ↑↓, Press YES

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Configuration and Calibration

Configuration and Calibration The T34TM Syringe Pump has adjustable operating parameters. These operating parameters and options may be viewed and adjusted to modify the operation of the pump. The operating parameters and options available are described below in the Technician Menu, Change Set Up Menu, Program Lock, and Keypad Lock sections. If access to a specific mode of operation is required, refer to the DFU for instructions.

Technician Menu To access the Technician menu: 1

Enter Technician mode by holding down the INFO key and then pressing the ON/OFF key simultaneously until the software version is displayed. Then, release the ON/OFF key. After several seconds, the access-code prompt displays. The display shows the software version for two seconds before the access-code prompt.

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Using the arrow keys, set code 123 and confirm by pressing the YES/START key. The pump displays all the parameters that can be set, calibrated or tested. The technician can scroll through all parameters using the arrow keys.

Table 1: Technician Menu Parameters Menu Item

Parameter/Option

Description

1

Exit from Technician

Exits Technician mode.

2

Serial Number

Displays the serial number and production date.

3

Main Self-Test

Runs through keypad, display, alarm sound, syringe sensors test, syringe diameter test, syringe travel test, battery voltage test and exit checks.

4

Manual Test

Same as Main Self-Test, but with a menu to focus the user on individual tests.

5

Syringe Setup

Adjusts the default diameter for the list of approved syringes.

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Pressure Calibration

Enables calibration and pressure settings.

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Factory Press. Test

Fine-tunes pressure calibrations.

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Pressure Test

Tests the actual pressure. (540mmHg ±160mmHg)

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Syringe Travel

Calibrates syringe movement of approximately 68 mm.

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Diameter calibration

Tests the syringe barrel sensor.

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Syringe Dead Space

Sets the actuator limitation for delivering the entire volume.

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Configuration and Calibration

Menu Item

Parameter/Option

Description

12

Volume Test

Performs a flow rate test.

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Factory Setting

Caution: Pressing START/YES restores factory defaults and deletes all pre-set protocols and setup changes.

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Operation Hours

Indicates the hours that have passed since the last service.

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Service Interval

Sets the number of hours before a Send for Service message appears.

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Purge Volume

Sets the maximum volume that a user can purge.

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Maximum Rate

Sets the Rate Limit (0.05 ml/h - 650 ml/h).

Enabling and Disabling a Syringe Type in the Pump Menu To enable/disable the syringe type: 1

Enter Technician mode, as described on page 19.

2

Use the arrow keys to scroll to Syringe Setup. Press YES/START to select this option.

3

The pump displays a syringe default size. Scroll up or down to the correct syringe size needed. Press YES/START to confirm.

Syringe size 2 ml Select ↑↓, Press YES

4

Use the arrow keys to scroll through the list of brands to the required syringe brand. Press YES/START to confirm.

Syringe Brand 50/60 Monoject Select ↑↓, Press YES

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Enabling: If the syringe has been disabled, Syringe Disabled-Refer to Ops Manual appears. To re-enable this syringe, press NO and then YES/START to confirm at the Enable this syringe?

50/60 Monoject Syringe Disabled Refer to Operations Manual

The display then shows a summary of the manufacturer’s data for that syringe. Press YES/START to confirm and exit Syringe Setup.

50/60 Monoject Enable this Syringe?

Disabling: To disable the selected syringe, from the screen in which the summary of the manufacturer’s data for the syringe is displayed, press NO. When prompted to disable the syringe, press YES/START. The Syringe Disabled screen displays.

6 ml Monoject Disable this Syringe

Press YES/START to exit Syringe Setup.

6 ml Monoject Syringe Disabled Refer to Ops Manual

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