T34 Functional Test Procedures Rev 2.4 July 2011

Contents: Introduction: ...page 3

Technical Specifications: ...page 4

Warnings and Cautions: ...page 5 Functional Test procedures...:………………………………..page 8

Main self test:...page 7

Occlusion Pressure testing:...page 8

Volume Testing:... ... ...page 9

Alarm Tests:...page 10

Data sheet:...page 11

Service Information:...page 12

Cleaning: ...page 13

Service and Maintenance:...page 14 Manufacturer:-

Distributor (UK & Ireland):-

Caesarea Medical Electronics Staufenburgstr. 23 72805 Lichtenstein/Germany

CME Medical UK Limited Kincraig Business Park, Kincraig Rd Blackpool, Lancashire.FY2 0PJ

Tel. 49 (0) 7129 92550 Fax 49 (0) 7129 925520 e-mail: [email protected]

Tel: 01253 894646 Fax: 01253 896648 e-mail: [email protected] 2

Rev 2.4 07/07/11

Introduction.

This document describes the functional test procedures for the T34 syring pump

Included in the document is a Functional test Procedure, a Volume test, an Occlusion Alarm Test procedure for the pumps.

It is recommended that all tests are performed at least every twelve months by a qualified biomedical equipment technician.

If a pump does not pass any of the test listed herein, the pump must be returned for servicing, to a certified technician whose has undertaken training provided by CME Medical UK Ltd. Training can be provided for biomedical engineers. When completed engineers can carry out a much more extensive range of testing and work on the devices.

Warning:

Before use, the user must become thoroughly familiar with the information contained in the device operating instructions.

Caution:

Do not attempt to disassemble or repair the T34 Syringe pump. Refer all service to personnel authorized by CME Medical (UK) Ltd.

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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 to 650ml/hr in 1ml increments(1000ml/hr available)

Actuator stroke:

67 mm available

Syringe sizes:

2 ml to 50 ml (most commonly used manufactures).

Pump Accuracy:

± 5 %.(pump and set combined)

Occlusion pressure:

Configurable to 150-1500mmHg, (10mmHg increments). Maximum actuator force 50N (5 Kgf).

Battery:

9V, primary alkaline, IEC 6LR61 (or 6LF22) type or Lithium rechargeable (not supplied)

Battery Operation:

7 Full 24 hour deliveries depending on infusion and setup parameters.

Indicators:

4 line LCD display (128x32 pixel) , Dual colour operation LED

Alarms:

Occlusion/Syringe empty End Program Low battery End battery

T34 Dimensions:

169 x 53 x 23mm.

Classification:

Type CF Equipment (degree of protection against electrical shock)

Housing:

ABS (fire retardant) IPX3

Weight:

210 gr. (without battery)

Electrical Safety:

Standards:

EMC:

Pump paused to long Syringe displaced Pump unattended

Complies with IEC 60601-1 (Medical Electrical Equipment Safety), IEC 601-2-24 (Infusion pumps and controllers), IEC 601-1-4 (Programmable Electrical Medical Sys-tems).

Manufactured in accordance to ISO 9001:2008 and ISO 13485:2003. CE marked in accordance with the Medical Devices Directive 93/42/EEC Devices Directive 93/42/EEC) The T34 syringe pump is designed to be in compliance with EN60601-1 (Safety) and IEC 601-1-2 (EMC)

Environmental Specifications:

Operating Conditions:

Transportation and Storage conditions: Temperature: Humidity: Air pressure:

o

o

o

Performance specifications may not be met if operated outside of the following conditions: o o o o Temperature: +15 C to +45 C (+59 F to + 113 F) Humidity: Air pressure:

o

20 % to 85% R.H. at +40 C, non-condensing 70kPa to 110kPa

4 Rev 2.4 07/07/11

o

-25 C to 50 C (-13 F to + 122 F) 5% to 100% R.H., non-condensing 48kPa to 110kPa

Warnings & Cautions

Warnings: advise you of circumstances that could result in injury or death to the patient or operator. Read and understand this manual and the Operations Manual heeding all warnings before operating or performing maintenance on the T34 syringe pump.

Cautions: advise you of circumstances that could result in damage to the device. Read and understand this manual and the Operations Manual heeding all cautions before operating or performing maintenance on the T34 syringe pump. 

NOTES: indicate that the information that follows is additional important information or a tip that will help you when operating or performing maintenance on the T34 syringe pump. Warnings To avoid possible personal injury or loss of life, always observe the following:

Read the entire Operation Manual before using the pump.

Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the T34 syringe pump and/or the accuracy of the infusion. Authorized skilled technicians should perform any adjustments, maintenance, or repair of the uncovered pump. Any adjustments, maintenance, or repair of the uncovered pump while connected to the power should be avoided. The T34 syringe pump should be operated within a temperature range of 15 C (50 F) to 45 C (115 F) and at up to 85% humidity. Operating the pump at temperatures and/or humidity other than within that range may affect accuracy. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system.

Dropping the T34 Syringe pump could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel. Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterizing equipment, and cellular telephones. False alarm signals may occur. Cautions To avoid possible damage to the equipment, observe the following:

Immersing the T34 Syringe pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid. 0

Battery damage could occur if left in a temperature warmer than 50 C

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Preventive Maintenance & Functional Test Procedures. Access codes: Technician code =123 Change user set up = 99 1. Print Pump Settings. Using Bodycomm and a docking station (if available) „Print pump setting‟ on to a copy of „CME T34 PPM Data Sheet‟ (a copy of this form is located at the rear of this procedure document). 2. Visual Check. Check the pump housing for physical damage. Using a brass pencil brush, clean the drive screw and the slide rails to ensure no debris or contaminates remain. 3. Syringe Recognition and volume detection test. Equipment required: T34 Syringe Pump Selection of Luer Lok syringes used in the Hospital or Trust. Method Switch the pump on and allow Pre-loading to complete. The position of the carriage should not be important except possibly for some smaller syringes where the actuator may have moved beyond the fully extended size of the syringe. Use the FF key to move the actuator to the desired position. FF key movement is limited for safety reasons so repeated presses may be necessary to position. For each of the syringes: 1. Lift the barrel clamp arm and place the syringe on the pump as described in the Operations manual ensuring the collar/flange and plunger are position correctly. Place the barrel clamp arm down on top of the syringe barrel. 2. The LCD screen should show the LOAD SYRINGE message and after a few seconds a volume and brand. If this screen remains with parts of the syringe graphic flashing (or a message is shown) check the loading of the corresponding syringe part or follow the message to complete correct placement of the syringe. 3. The pump should ALWAYS display the correct volume but may not always immediately give the correct brand. Use the arrow keys to scroll through the list of syringe brands (pump shows those within +/-3% diameter of the one loaded). Select the correct syringe brand and Press Yes to confirm selection. 4. Read the actual volume on the syringe and compare it with what the pump reads the volume as, these results should be within +/-2%. If the result does not fall within the expected range: a. Check that there is no slack in the system (visible space in the seating of the plunger or the collar/flange. In such cases purge may be required before repeating the test (refer to Operations Manual) b. Re-check that the syringe loaded is the same brand as confirmed at step 4 c.

If the error remains outside of specification after checking point a & b then the pump has failed the test and corrective action is required, refer to syringe travel calibration in the service manual. 5. Remove the syringe, turn the pump off, place the arm down and repeat steps 1-

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4. Main Self Test

Switch the pump on in to Technicians menu by pressing the

and switch on the unit

pressing the keeping the info pressed release your finger off the on/off button software version will be displayed followed by “ Enter Tech Code” enter technician code 123. Scroll down to „Main Self Test‟ routine, as this will verify all the systems are functioning correctly, if the any of these test fail the pump will need to be repaired or calibrated. Main Self test cycles through the following tests: 1. Keypad Test – each key displayed needs to be pressed

2. Display Test – The LCD will flash, press „Yes‟ to continue 3. Acoustic Alarm Test – Buzzer will sound 4. Syringe Sensors Test – Follow instructions on pump display 5. Syringe Diameter test – Insert a known Diameter tolerance ±0.2mm 6. Syringe Travel Test – The actuator will run to the front of the pump then to back of the pump and then to the front. 7. Battery Voltage – Measure Battery voltage across the battery terminals tolerance ±0.1V

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5. Occlusion Test Equipment needed: New 5ml & 50ml Luer Lok Syringe filled with Water for Injection Pressure gauge Set Occlusion alarm to 540mmhg in change user setup. 1. Prepare the syringe and infusion set by attaching set to the syringe and manually priming the infusion set to eliminate ALL air from the system. 2. Switch the pump on in Technicians Menu. Scroll down to „Pressure Test‟ 3. Connect the syringe to the pressure gauge assembly (as shown below). 4. Position the carriage to fit the syringe using the FF or Back key 5. Lift the barrel clamp arm and Load the syringe. Use the arrow/scroll keys to select the correct make from the list (as described in the Operations Manual). Press „YES‟ to confirm selection 6. Press „YES‟ to confirm and start the test, with tap open let a few drops out, then close the 3way tap.

7. The Pressure will be displayed on the LCD and can be seen rising. 8. The pump will display the pressure that it has alarmed at on the LCD; check Occlusion alarm operates within a ±160mmHg tolerance range.

Repeat the above procedure for the 50ml syringe Setup for T34 Occlusion Pressure Testing 3Way Stop Cock Test Syringe McKinley T34 Syringe Pump

Digital Pressure Indicator

i

YES

NO

ON

INFO

START

STOP

OFF

If the unit is out of specification, please refer to the service manual for calibration.

Please note when doing a occlusion pressure test, use a new syringe every time. There are many variants that need to be taken into consideration when doing an occlusion test, Like old syringes, line restrictions, viscous fluids and high flow rates. We recommend not using IDA devices to test our syringe pumps as results can be erratic.

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6. Volume Test Equipment needed:Linear Accuracy Test Method: Dry Testing Equipment needed:New 5mL BD Plastipak Luer Lok Syringe Digital Vernier Calliper 1. 2. 3. 4. 5. 6. 7. 8. 9.

Switch the pump on in technician mode Scroll through options to Volume Test Load a 5ml BD Plastipak Luer Lok syringe with 4.5ml of air onto the pump Before selecting the syringe use the FF key to advance the syringe to the 4ml mark Select 5ml BD Plastipak Using vernier callipers measure the distance between Point A and Point B (see photo below) Set the rate to 10ml/h Set the volume to 2ml Allow the pump to deliver the 2ml

10. When the pump has stopped (12minutes) measure the distance between Point A and Point B again. 11. Subtract the second measurement from the first measurement 12. To pass the test the result should be 17.4mm ±2% (17.05mm and 17.75mm)

A B

Please note when doing a volume test to take in to consideration the tolerance of the syringe pump which is ±2% and for the syringes, an example BD syringes have a ±4% tolerance. Only use Luer Lok syringes, using luer slip will result in volume delivery error. st nd Example result to give a percentage error, 1 measurement 36.95mm after 2ml volume delivery 2 st nd measurement 19.45mm minus the 1 reading from the 2 = 17.50mm ÷ this by 17.4mm x by 100 then 100 gives us a percentage error of + 0.57%.

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7. Alarms T34 has the following alarms: Syringe displaced – To test while the T34 is pumping take the syringe off the pump, the alarm is activated and a screen message describes the cause. Occlusion/Syringe Empty – Pump has sensed a pressure above the alarm level. Possible occlusion or actuator has reached end of travel/syringe empty. Tested during Occlusion Test Pump Paused to Long – Leave the pump on a setting screen and do not press any key for 2 minutes, the pump should alarm after two minutes. Low Battery – Alarms when the pump detects a Low Battery voltage End Battery - Alarms when the Battery is exhausted. Near End or Program Nearly Complete - Alarms when the current program, is due to finish. End Program – Volume to be infused set during programming has been infused.

8. Battery Operation The T34 Syringe pump operates on battery power. Note: User should verify that the battery is in good condition, by pressing the info key during program set up or operation, pressing twice the info key to display the battery status. There are two battery alarm conditions: 1. The pump will warn „Low battery‟ before the “End battery” alarm activates. 2. When the battery is depleted, the pump will cease operation and the "End battery" alarm will be activated. If the battery runs out, End Battery appears on the display. The pump stops the infusion. From the "End battery" state the user cannot restart the pump, until the battery has been replaced with a new one.

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1.

CME T34 PPM Data Sheet vr1

Customer or Serial number Accessories included

Box Pouch

2. Visual Inspection

Pass

Ops Man. Lockbox

Fail Give details

Initials

3. Syringe Recognition and Volume Detection Test Initials

4. Main Self Test

Pass/Fail

Key Pad Test Display Test Acoustic Alarm Test Syringe Sensors Test Syringe Diameter Test Syringe Travel Test Battery Voltage

v v

Displayed Measured

Initials

5. Occlusion Pressure

mmHg

(Displayed Pressure ±160mmHg)

6. Volume Test

%

Error

7. Alarm Test

Initials

Reset Factory Settings (if required)

Initials

BodyComm Load Global Macro (if required)

Initials

Clean Casing

Initials

Attach Labels

Completed By …………………………Date…………………..

Ensure All Accessories are included when returned with pump 11 Rev 2.4 07/07/11

Service Information While under warranty or a service agreement, the equipment should only be opened by CME Medical service personnel or on the instruction and agreement of the company or the warranty/contract will be invalidated. The customer will pay all shipping costs (returned for service or under warranty). Unless otherwise agreed. The unit must be packed in its original packaging or in another container that will provide adequate protection during shipping. To assure prompt return, the CME Medical Service department must be notified before shipping any unit for repair on 01253 894646 and reference made to appropriate warranty or service agreement or an order number provided. Please provide the serial number of the device. A brief written description of the problem or reason for return (e.g. „Routine annual service‟) should be included with the pump.

Failure Identification In „Change Set up‟ (on the main menu) users can access the Event Log of the last 512 events on the pump, to help identify the conditions and settings at the time of pump failure. User can scroll through the last 512 events. Press on the arrow up key to show the next event. The events are displayed from the last to the first. Pressing the

key on a specific event will display further information on pump settings at the time of the event.

This information may help to determine the nature of the failure and could be useful in troubleshooting its cause or excluding user error.

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Cleaning Cleaning Before connecting the pump to a patient, and periodically during use, clean the unit using a lint-free cloth lightly dampened with warm water and a mild detergent or 10% bleach solution.

Warning: Always turn the pump off, and remove the battery before cleaning.

Warning: Always unplug the charger from mains power before cleaning.

Caution:

Xylene, Acetone or similar solvents could cause damage to components. Do not clean the pump with these chemicals. Clean solution spills on the pump immediately. Use a damp cloth or sponge. A mild detergent or a 10% bleach solution may be used. Wipe thoroughly with a dry cloth.

Caution:

Do not soak or immerse any part of the pump or charger in water.

Storage If the pump is to be stored for an extended period it should be cleaned and the battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packaging for protection.

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Service and Maintenance •

Return-to-base (14 day turnaround). 4 levels of Service Contracts... Bronze, Silver, Gold & Platinum.

•

Loaner equipment available(on Platinum contracts only)

•

Technical training 1st line and 2nd line courses.

•

Spare parts can be provided to medical engineers who have been technical trained by CME, so they can maintain equipment on-site.

•

Parts held at CME Medical UK facility (next day delivery).

Contact information: Service Tel: 01253894646 Email: [email protected] Website: http://www.cmemedical.co.uk

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