T34L, NeoFeed, SP300 and T34L-PCA Technical Service Manual Edition Rev 01

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.

0344 T34L™ 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 ...7 Overview ... 7 Intended Use ... 7 Purpose of This Manual ... 7 Introduction to the T34L™ Syringe Pump ... 8 Technical Overview ... 9 Occlusion Detection in the T34L™ Syringe Pump ... 9 Motor Control in the T34L™ Syringe Pump ... 10 Performance Verification ... 10 Safety ... 11 System Symbols ... 11 Warnings and Cautions ... 12 Electrical Safety Compliance ... 14 Electromagnetic Compatibility (EMC) ... 14 Alarms ... 14 Alarm Conditions ... 14 Alarm Types... 14

2

Configuration and Calibration ...15 Battery Operation ... 15 Locking ... 15 Keypad Locking ... 15 Program Locking ... 16 Maximum Rate Locking ... 16 Configuration and Calibration ... 17 Technician Menu ... 17 Change Setup ... 19 Occlusion Pressure Calibration ... 21 Syringe Travel Calibration ... 22 Syringe Diameter Calibration ... 22 Communication (Between the PC and the Syringe Pump) Via the Infrared Communication Port ... 23 Required Equipment ... 23 Installing and Configuring BodyComm™ on a PC ... 23 Event Log ... 34

3

Preventative Maintenance ...35 Introduction ... 35 Recommended Cleaning and Storage ... 35 Cleaning ... 35 Storage ... 35 Routine Preventive Maintenance ... 36 Tools and Test Equipment ... 36 Performance Verification and Calibration Tests ... 37 Introduction ... 37 Pre-service Checklist ... 37 Setting Up the Pump for Testing ... 38

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Table of Contents

Infusion Test ... 39 Volume Test... 40 Factory Press. Test ... 40 Pressure Test ... 41 Performance Verification Workflow ... 42 Remove Program Lock ... 42 Syringe Recognition and Volume Detection Test ... 43 Volume Delivery Test ... 44 Occlusion Test ... 44 Alarms Test ... 45 Restore Program Lock ... 46 Visual Inspection... 46 Service Decision Route ... 46 Service Process Flow Chart ... 48 Service Information ... 49

4

Troubleshooting...51 List of Events and Alarms ... 56 Failure Identification ... 57

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Corrective Maintenance ...59 Introduction ... 59 Access Code List ... 59 Software Burning Instructions ... 60 EQUIPMENT ... 60 Burning Station Connections ... 61 Procedure ... 63 Disassembly ... 69 Tools and Test Equipment ... 70 Pump Disassembly/Assembly ... 70 T34L™ Syringe Pump Default Settings ... 82

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Service Center Recommended Part List ...87

A

PVP – T34L™ ...93

B

Drawings and BOM ...95 Front Housing Assembly ... 95 Block Assembly ... 96 Actuator Assembly... 97 Rear Assembly ... 98 Pump Assembly (PCA Version) ... 99 Main PCB Wiring Schematic ...100 Rear PCB Wiring Schematic ...105 Keypad PCB Schematic ...106 Main PCB ...107 Rear PCB ...109 Keypad PCB ...110

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Table of Contents

BOMs ...111 Syringe Pump Main PCB Version 5 – Bill of Material ...111 Syringe Pump Rear PCB – Bill of Material ...113 Syringe Pump Keypad PCB – Bill of Material ...113

C Limited Warranty ...115 D

Specifications ...117

List of Figures Figure 1: T34™ Syringe Pump Block Diagram ... 11 Figure 2: BodyComm™ Connections Setting Window ... 25 Figure 3: BodyComm™ Initial Connection Message ... 25 Figure 4: Dongle Installation ... 26 Figure 5: Syringe Pump Connected Window (Main Window) ... 27 Figure 6: Syringe Data – Syringe Brands Window ... 28 Figure 7: Pump Setting Window ... 29 Figure 8: Technician Settings Window ... 30 Figure 9: Global Macro Commands Window ... 31 Figure 10: Global Macro Window – New Macro... 32 Figure 11: Actual State – Syringe Pump Connected Window ... 33 Figure 12: Events Window ... 34 Figure 13: Checking the Sensors ... 38 Figure 14: Service Process ... 48 Figure 15: RS-232 Burning Station Connector ... 61 Figure 16: RS-232 Connector Connected to Burning Station... 61 Figure 17: DC Cable with Wall Charger Connected to Burning Station ... 61 Figure 18: Burning Station Cable 5P Connector Connected to Burning Station ... 62 Figure 19: Burning Station Cable Connected to PCB ... 62 Figure 20: Main PCB Connected to Burning Station ... 63 Figure 21: Attempting to Contact Target and Pass Security Window ... 64 Figure 22: Specifying Programming Algorithm to Use Window ... 65 Figure 23: Choose Programming Function – Window 1 ... 65 Figure 24: Choose Programming Function – Window 2 ... 66 Figure 25: Choose Programming Function – Window 3 ... 67 Figure 26: Specify S19 File to Load Window ... 67 Figure 27: Choose Programming Function – Window 4 ... 68 Figure 28: Choose Programming Function – Window 5 ... 69 Figure 29: Rear Housing Screw Assignments ... 71 Figure 30: Separating the Front and Rear Housing ... 72 Figure 31: Upper Label – Uncovered Fixing Screw ... 73 Figure 32: Disconnecting the Motor Connector ... 73 Figure 33: Pulling Out the Block Assembly ... 73 Figure 34: Releasing the Spacer Fixing Screws ... 74 Figure 35: Disconnecting the Display from the Main PCB ... 75 Figure 36: Removing the Protective Seal from the Buzzer ... 75 Figure 37: Required tools (left) and Releasing the Wire Connectors (Right) ... 76

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Table of Contents

Figure 38: Releasing the Motor from the Block ... 76 Figure 39: Separated Motor and Front Block ... 77 Figure 40: Wiring Placements ... 77 Figure 41: Soldered Contacts... 78 Figure 42: Collar Sensor with Spring Locker (Left) and Removal of Collar Sensor (Right) ... 78 Figure 43: Rear PCB Fixing Screws with Washers ... 79 Figure 44: Rear PCB Positioning ... 79 Figure 45: Treating the Rear PCB's Potentiometer Part ... 79 Figure 46: Sealing the Gap Between the Rear PCB and the Housing ... 80 Figure 47: Collar Sensor Insertion – 1 ... 80 Figure 48: Collar Sensor Insertion – 2 ... 81 Figure 49: Metric Feeler Gauge (Right) and Measuring 0.9 mm (Left and Bottom) ... 81 Figure 50: Adjusting the Collar Sensor Contact ... 82 Figure 51: Front Housing Assembly ... 95 Figure 52: Block Assembly ... 96 Figure 53: Actuator Assembly ... 97 Figure 54: Rear Assembly ... 98 Figure 55: Pump Assembly – PCA Version... 99 Figure 56: Main PCB Wiring Schematic – 1 ...100 Figure 57: Main PCB Wiring Schematic – 2 ...101 Figure 58: Main PCB Wiring Schematic – 3 ...102 Figure 59: Main PCB Wiring Schematic – 4 ...103 Figure 60: Main PCB Wiring Schematic – 5 ...104 Figure 61: Rear PCB Wiring Schematic ...105 Figure 62:Keypad PCB Schematic ...106 Figure 63: Syringe Main Version 5A – Assembly Bottom ...107 Figure 64: Syringe Main Version 6 – Assembly Top ...108 Figure 65: T34L™ Rear – Version 3 – Assembly Top ...109 Figure 66: T34L™ Rear – Version 3 – Assembly Bottom ...109 Figure 67: T34L™ Keypad – Version 3 – Assembly Top ...110 Figure 68: T34L™ Keypad – Version 3 – Assembly Bottom ...110

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1 General Information Overview The T34L™ is a lightweight, battery-powered, advanced syringe infusion pump with a space-saving design. Its many programming, safety and convenience features make it the T34L™ easy to manage for any infusion protocol, wherever the patient requires care. The pump contains a rechargeable Li-Polymer battery, enabling complete autonomy. The T34L™ has an automatic syringe detection system by which it can identify all commonly used syringe brands using three independent sensors. Other safety features include three-level access-code protection, keypad lock, event log and full alarm protection.

Intended Use The T34L™ Syringe Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural or enteral, 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, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

Purpose of This Manual 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 the 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 the BodyComm™ Operation Manual 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 T34L™ Syringe Pump 1

23

4

5

6

7 8

9

15

14 13 12 11

10

1

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

2

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

3

Operation LED:

4

o

Green while infusing.

o

Red when stopped or when there is an alarm. An alarm can be disabled.

Plus Key: o

Increases infusion parameters during programming/use.

o

Scrolls between options.

5

STOP/NO Key: Moves back one step during programming or stops the pump.

6

Back Key: Moves the actuator backward when no syringe is present.

7

Plunger Sensor: Detects correct loading of the syringe plunger.

8

Actuator: Drives the syringe plunger to deliver syringe contents.

9

Graphic LCD Display: o

128 pixels x 32 pixels.

o

The backlight duration is configurable.

o

When any key is pressed, the backlight turns on.

10 INFO Key: o

Shows the event log, volume infused, volume to be infused and battery status.

o

A long press locks/unlocks the keypad.

8

General Information

11 Minus Key: Drives the syringe plunger to deliver syringe contents: o

Decreases infusion parameters.

o

Scrolls between options.

12 START/YES Key: Confirms selections during programming. 13 FF (Forward) Key: Moves the actuator forward when no syringe is loaded. 14 ON/OFF Key: Turns the pump on or off while in the Stop state. 15 Infrared Communication Port

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 permanent magnet motor with a gearbox. The T34L™ 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 T34L™ Syringe Pump To minimize the battery size in the T34L™ Syringe Pump, the T34L™ 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 380–700 mmHg. Variations in friction of the syringe affect the occlusion pressure. Therefore, it is important to use a new syringe when verifying performance. Syringe friction rapidly increases after only a few occlusion measurements.

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General Information

Motor Control in the T34L™ 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). 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.

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 component’s alarms and functions.

10

General Information

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.

Figure 1: T34™ Syringe Pump Block Diagram Only three actual physical measurements need to be made: Volume Occlusion pressure Syringe barrel clamp arm

Safety System Symbols The following symbols are used on the T34L™ 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. Caution.

Refer to operating instructions. 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.

11

General Information

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 number. Sterilized with Ethylene Oxide.

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 T34L™ Syringe Pump Operation Manual, taking note of all warnings before operating or performing service on the T34L™ Syringe Pump. Caution: Cautions advise you of circumstances that could result in damage to the device. Read and understand this manual and the T34L™ Syringe Pump Operation Manual, taking note of all cautions before operating or performing service on the T34™ Syringe Pump. Note: Indicates that the information that follows is additional important information or a tip to help you when operating or performing service on the T34L™ Syringe Pump.

Warnings To avoid possible personal injury or death, observe the following warnings: Warning: Read the entire T34™ Syringe Pump Operation Manual before using the pump, since the text includes important precautions. Warning: The T34L™ syringe brand detection is based on the 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 that 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 ensure that the visual volume in the syringe matches the actual volume on the T34L™ display.

12

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 depends on syringe size and brand and is equivalent to three motor revolutions. 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 T34L™ 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 non-sterile 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. Warning: Do not open the pump if connected to mains. It may cause severe injury.

Cautions To avoid possible damage to the equipment, observe the following cautions: Caution: Do not store the pump with battery for more than six months. Charge the pump periodically at least every three months. 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.

13

General Information

Caution: Immersing the T34L™ 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.

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

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 occur: An alarm message appears on the display, stating the cause of the alarm and indicates instructions for continued use. The operation LED lights red. An audible alarm sounds. The infusion stops.

Alarm Types Down Occlusion Pump Unattended Low Battery End Battery Internal Malfunction End Program End Travel Syringe Displaced Near End: The first of 15 minutes before completion or 15 mm, whichever occurs first. Refer to Troubleshooting on page 51 for the alarm causes and corrective actions. Refer to Alarms Test on page 45 for instructions on testing the alarms.

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2 Configuration and Calibration Battery Operation The T34L™ Syringe Pump operates on a rechargeable 7.4V Li-Ion-Polymer battery. Note: Verify that the battery is loaded by pressing the INFO key during program setup or operation. Press the INFO key twice to display the battery status. There are two battery alarm conditions: 1

The pump warns that the battery is low before the End Battery alarm activates.

2

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.

Low Battery

End Battery

From the End Battery state, the user cannot restart the pump until the battery is charged.

Locking The T34L™ Syringe Pump provides three types of locking: Keypad Locking, below Program Locking, page 16 Maximum Rate Locking, page 16

Keypad Locking During operation, all keys are disabled, excluding the STOP/NO and INFO keys. During programming, all keys are disabled, excluding the START/YES and INFO keys.

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.

15

Configuration and Calibration

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.

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, if there is a 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 twice.

2

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

Info Menu Change Setup Select ↑↓, Press YES

3

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

4

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

Change Setup Program Lock Select ↑↓, Press YES

5

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 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. Note: Program locking is not available for all versions.

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.

16

Configuration and Calibration

To set the Maximum Locking Rate: 1

Enter Technician Mode by pressing INFO key and the power ON/OFF key down simultaneously until the software version is displayed. Then, release the ON/OFF key. After several seconds, the access code prompt appears.

2

Using the arrow keys, set code 123 and confirm by pressing the YES/START key.

Enter Tech Code 123 Change ↑↓, Press YES

3

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

Technician Options: Maximum Rate Select ↑↓, Press YES

4

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

Configuration and Calibration The T34L™ 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 operation manual for instructions.

Technician Menu To access the Technician menu: 1

To access the Technician menu, press and hold the INFO key and POWER button at the same time until the Technician code prompt appears. The display shows the software version for two seconds before the access code prompt.

2

Enter code 123 and press OK. The pump displays all the parameters that can be set, calibrated or tested. The technician can scroll through all parameters using the arrow keys.

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Configuration and Calibration

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.

Main Self-Test

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

Manual Test

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

Syringe Setup

Adjusts the default diameter for the list of approved syringes.

6

Pressure Calibration

Enables calibration and pressure settings.

7

Factory Press. Test

Fine-tunes pressure calibrations.

8

Pressure Test

Tests the actual pressure.

9

Syringe Travel

Calibrates syringe movement of about 68 mm.

10

Diameter calibration

Tests the syringe barrel sensor.

11

Syringe Dead Space

Sets the actuator limitation for delivering the entire volume.

12

Volume Test

Performs a flow rate test.

Factory Setting

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

Operation Hours

Indicates the hours from the last service.

Service Interval

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

16

Purge Volume

Sets the maximum volume that the user can purge.

17

Maximum Rate

Sets the Rate Limit (0.05 ml/h650 ml/h).

3

4 5

13 14 15

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

Enter Technician mode, as described on page 17.

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 brand of the syringe needed. Press YES/START to confirm.

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

18

Configuration and Calibration

5a

5b

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? prompt.

50/60 BD Plastipack 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

Change Setup To change setup options: 1

Press the ON/OFF key to turn on the pump. Press the INFO key twice.

2

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

Info Menu Change Setup Select ↑↓, Press YES

3

The access code for Change Setup 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 through the setup options (see Table 2) and change where necessary.

Change Set up Exit Select ↑↓, Press YES

Table 2: Change Setup Options Change Setup Option

Functional Description

Exit

Select to exit Change Setup.

Set Time and Date

Enables you to adjust the date and time to ensure that all logged events are stamped with the correct date and time.

FF Key Operation

Defines the actuator’s forward movement distance when the FF key is pressed during syringe loading.

Range

0.1 mm–100 mm.

19

Configuration and Calibration

Change Setup Option

Functional Description

Range

Backlight Duration

Defines the duration that the backlight lights up to help preserve battery life.

0–60 seconds up to ON. ON never turns off the display backlight.

Info Duration

Defines the duration that the Info screen displays.

120 seconds,

Operation LED

Enables the green LED flashing operation to be disabled or enabled (from 2–64 seconds). This setting option helps preserve battery life. The red warning LED is not affected.

Disable (0) to 64 seconds.

*Bolus Maximum Volume

*Availability of this option depends on the software version. Enables you to set the bolus maximum volume value. Setting zero (0) disables bolus administration.

020 ml.

Titration Option

Enables or disables titration functionality.

Enabled/Disable.

Default Duration

Defines the program’s default duration. If you set zero (0:00), the pump skips the duration step during programming. When the Program Lock is ON (see below), the default duration cannot be set to zero.

0:01–99:00.

Occlusion Pressure

Enables you to set the pressure at which the occlusion alarm is activated.

100 mmHg– 1,500 mmHg

KVO Operation Rate

Enables you to set the Keep Vein Open infusion rate to be administered when the program ends.

0 (KVO off) to a maximum of 2 ml/h.

Program Lock

Enables you to set a lock on the program to prevent tampering with either the program duration or rate during setup (when the Program Lock is ON, the Default Duration cannot be set to zero).

ON/OFF

Info Mode During Operation Volume Infused

VTBI 3.8

VI

1.3

Battery Level Empty

98% Full

Pressing the INFO key during operation displays the total Volume To Be Infused and the Infused Volume. The screen displays for seven seconds. Pressing the INFO key twice during operation displays the battery status. The screen displays for seven seconds.

Note: To exit Info mode, press the INFO key or wait 10 seconds.

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