T34 Operator Manual Sw Ver NCAT - NCATBOL Rev 04

Contents SECTION 1: GENERAL INFORMATION ... 3 1.1 Preface ... 3 1.2 About this manual ... 3 1.3 Advisory terms and operating precautions and warnings ... 3 1.4 Intended use ... 5 1.5 Contraindications... 5 1.6 System symbols ... 6 1.7 Syringe pump specifications ... 7 1.8 Limited Warranty ... 8 1.9 Pump inspection and unpacking ... 9

SECTION 2: DISPOSABLES AND ACCESSORIES ... 10 2.1 Syringe brands and sizes ... 10 2.2 Administration sets ... 11 2.3 Battery power supply ... 13 2.4 Lockbox ... 16 2.5 Carry Pouches ... 16

SECTION 3: PUMP FEATURES AND DESCRIPTION ... 18 3.1 Overview ... 18 3.2 Pump description ... 18 3.5 Event Log ... 20 3.6 Post Occlusion Bolus Reduction System (POBRS) ... 21

SECTION 4: MODES OF OPERATION ... 23 4.1 Modes of operation ... 23

SECTION 5: PUMP CONFIGURATION ... 26 5.1 Pump configuration ... 26 5.2 Pump access codes ... 27 5.3 Pump INFO and configuration menus ... 27 5.4 Pump Configurable settings for modes of operation ... 29 5.5 Optional configurable settings ... 30 5.6 Practise scenarios for changing pump configuration ... 31

SECTION 6: STARTING A NEW INFUSION ... 34 6.1 Sequence for starting an infusion ... 34

SECTION 7: MONITORING AND MANAGING INFUSIONS ... 43 7.1. Pump and infusion safety checks... 43 7.2 Keypad lock ... 45 7.3 Program protection and “Resume” ... 46 7.4 Stopping/pausing the infusion and powering off ... 47 7.5 Alerts, alarms and troubleshooting ... 47 7.6 Changing syringes/administration sets ... 49 7.7 Servicing and maintenance ... 50

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SECTION 1: GENERAL INFORMATION 1.1 Preface Duplication or distribution of this manual and any information contained within is strictly prohibited without the express written permission of CME Ltd. This manual and any information contained within, may not be reproduced, distributed, or transmitted in any form, or by any means, for any purpose, without the express written permission of CME Ltd. To order additional copies of this manual, or other related manuals, contact CME Ltd. Head Office. The information in this document has been carefully compiled, and is believed to be entirely reliable. However, no responsibility is assumed for inaccuracies. Furthermore, CME Ltd. reserves the right to make changes to any products herein to improve readability, function, or design. CME Ltd. does not assume any liability arising out of the application or use of any product described herein; neither does it cover any license under its patent rights nor the rights of others.

1.2 About this manual The operator must be thoroughly familiar with the T34™ ambulatory syringe pump described in this manual prior to use, and in particular must read and understand any warnings and precautions stated herein. If a software change occurs and the operation/specification for the pump changes, new or additional operating instructions will be issued, if needed. All illustrations used in this manual show typical settings and values that may be used in setting up the functions of the pump. These settings and values are for illustrative use only. The complete range of settings and values are listed in the specifications section of this manual. This operation manual document has been developed with consideration to the requirements in relevant Harmonised Standards. Data presented in the technical specifications reflect specific test conditions defined in this standard. Other external factors such as varying back pressure, temperature, head height, set usage, fluid restrictions, solution viscosity or combinations of these factors, may result in deviations from the performance data enclosed.

1.3 Advisory terms and operating precautions and warnings Warnings, precautions and notes Warnings and notes will be seen throughout this manual. These are described as: NOTE: Indicate that the information that follows is additional important information, a tip that will help you recover from an error or point you to related information within the manual. PRECAUTION: Indicates that the information is a precaution. Precautions advise you of circumstances that could result in damage to the device. Read and understand this manual and all precautions completely before operating T34™ ambulatory syringe pump. WARNING: Warnings advise of circumstances that could result in injury or death to the user/operator or circumstances that could result in damage to the device. Read and understand this manual and all warnings before operating the T34™ syringe pump. Software Version NCAT / NCATBOL

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Operating precautions and warnings o

o o

o

o

o

o

o o o

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation. Although the T34™ syringe pump has been designed and manufactured to exact specifications, it is not intended to replace trained personnel in the supervision of infusions. CME Ltd. will assume no responsibility for incidents which may occur if the product is not used, stored or transported in accordance with the environmental conditions stipulated in this document or on the package labelling. This syringe pump is designed for ambulatory use and should withstand everyday handling. If the pump is dropped onto a hard surface, or is suspected of being dropped, the operation and calibration should be checked by a qualified technician. The specified accuracy of the pump can only be maintained if the pump is used, maintained and serviced in accordance with the instructions given in this manual. If the pump has failed to calibrate during the servicing procedure, it must be returned for repair or disposal. Adjustments, maintenance, or repair made by un-certified service personnel may impair the operation of the pump and/or the accuracy of the infusion. Make sure any adjustments, maintenance, or repair of the device are carried out only by authorised and skilled technicians. Refer all service, repair and adjustments only to qualified and certified technical personnel. Unauthorised modifications or the use of any spare parts, other than those supplied by the manufacturer or their distributor, will void any warranty. 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 personnel. The pump has been designed to be as safe as possible to handle; however, care should be exercised to avoid trapping of fingers or other body parts in the mechanism. The T34™ syringe pump system should be operated within a temperature range of -15°C (-59°F) to +45°C (+113°F). Operation at temperatures outside this range may affect accuracy.

Infusion precautions and warnings o o

o

o o o

Carefully read and follow accompanying set instructions for priming the set and the recommended set change interval. The syringe and administration set should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within and in accordance with the hospital/homecare provider’s disposal practices. Drugs for infusion to be used with the pump may only be prescribed by a qualified medical practitioner. Caution must be exercised in the selection of drugs and the amount and rate intended to be delivered via any infusion pump. If the drug contained in the syringe will be exposed to extreme environmental conditions for prolonged time periods, it is important to select drugs that will not change pharmacologically upon such exposure. As with all automatic infusion devices, whenever a toxic or dangerous level of drug is stored in the reservoir, constant/frequent monitoring of the infusion is required. In all applications, time to alarm under occlusion or other fault conditions will depend on the infusion rate and levels of alarm settings. It is recommended to consider these parameters when using drugs requiring infusion stability or low flow rates and therefore a quick time to alarm.

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General precautions and warnings o

The T34™ syringe pump must always be used in a CME Ltd pouch or similar receptacle if used in direct sunlight. If the pump is exposed to direct sunlight, it may affect functionality.

o o

Do not use hard or sharp objects on the keypad. Do not bath or shower whilst using the pump. The pump is resistant to a limited amount of splashing, but its construction does not make it resistant to large amounts of spraying or immersion in liquids. Damage to the internal components may result. 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 personnel. Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterising equipment as this may result in false alarm signals or error messages being displayed.

o o

1.4 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, epidural 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, chemotherapeutic agents and general fluids therapy in hospital and homecare environments.

1.5 Contraindications o o o o

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

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1.6 System symbols The following symbols are used on the T34™ syringe pump and components. Labels on the pump or statements in this manual preceded by any of the following words and/or symbols are of special significance and/or are intended to help you to operate the pump in a safe and successful manner.

System symbol identification and description Symbols

Description

Pump Attention, consult the accompanying instructions.

Attention, refer to operating instructions.

CSA mark.

CE mark indicates conformance to Medical Device Directive 93/42/EEC.

IPX3

Symbol for degree of protection against ingress of water.

Do not dispose of battery in municipal waste. Symbol indicates separate collection for battery is required. Type CF applied part. Date of manufacture.

Manufacturer.

SN

Serial number. Disposables The use of single-use disposable components on more than one patient is a biological hazard. Do not reuse single-use disposable components. Expiry date (consumables).

LOT

Lot number (consumables).

STERILE EO

Sterilized with Ethylene Oxide.

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1.7 Syringe pump specifications T34™ syringe pump specifications Type: Flow Rate: Actuator Travel: Syringe Sizes: Accuracy: Occlusion Pressure: Battery: Battery Operation: Indicators:

Syringe Pump with motor driven linear actuator, pulsed motion (540 pulses per mm). 0.05- 10mL/h in 0.01mL increments, 10 to 650mL/h in 1 mL increments (1000 mL/hr available). c.67 mm available. 2 mL to 50 mL (most commonly used manufacturers). ± 5 % system accuracy (pump and set combined). 100-1500mmHg configurable (10mmHG increments). Max. actuator force 50N (5 Kgf). 9V alkaline, IEC 6LR61 type (or Lithium for extended life). 7 full deliveries depending on infusion and set up parameters. 4 Line LCD display (122 x 32 pixels) , Dual color operation LED When a problem is detected, the T34™ displays the following alarm messages, sounds an audible alarm and the LED lights red:

Alarms:

T34™ Dimensions: Classification: Housing: Weight: Electrical Safety: Standards: EMC:

Environmental Specifications:

Occlusion or Syringe Empty End Program End Battery

Pump Paused Too Long Syringe Displaced Syringe Empty

169 x 53 x 23mm. Type CF Equipment, degree of protection against electrical shock, IPX3 protection against ingress of water. ABS (fire retardant). 210 gr. Without battery. Complies with IEC 60601-1 (Medical Electrical Equipment Safety), IEC 601-2-24 (Infusion pumps and controllers), IEC 60601-1-4 (Programmable Electrical Medical Systems). Manufactured in accordance to ISO 9001:2008 and ISO 13485:2003. CE marked in accordance with the Medical Devices Directive 93/42/EEC. CME Ltd. T34™ syringe pump is designed to be in compliance with EN60601-1 (Safety) and IEC 601-1-2 (EMC). Non-Operating Conditions (Transportation and Storage): Temperature: -25oC to 55 oC (-13 oF to +131 oF) Humidity: 5 % to 100% R.H., non-condensing Air pressure: 48kPa to 110kPa Operating Conditions: The system may not meet all performance specifications if operated outside of the following conditions: Temperature: +15oC to +45 oC (+59 oF to +113 o Humidity: 20 % to 85% R.H. at +40 oC, non-condensing Air pressure: 70kPa to 110kPa

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1.8 Limited Warranty The T34™ syringe pump has been carefully manufactured from the highest quality components. Caesarea Medical Electronics Ltd. (CME) guarantees the pump against defects in material and workmanship for twelve (12) months from date of purchase. CME’s obligation, or that of its designated representative under this Limited Warranty, shall be limited, at CME’s option, or that of its designated representative, to repairing or replacing pumps, which upon examination, are found to be defective in material or workmanship. The repair or replacement of any product under this Limited Warranty shall not extend the abovementioned Warranty period. All repairs under this Limited Warranty should be undertaken only by qualified, trained service personnel. In the event that a pump is found to be defective during the warranty period, the purchaser shall notify CME or its designated representative within thirty (30) days after such defect is discovered. The defective pump should be sent immediately to CME or its designated representative for inspection, repair or replacement. Shipping costs are the purchaser’s responsibility. Material returned to CME or its designated representative should be properly packaged using CME shipping cartons and inserts. Inadequate packaging may result in damage to the pump. This Limited Warranty shall not apply to defects or damage caused, wholly or in part, by negligence, spilt fluids, dropping of the pump, misuse, abuse, improper installation or alteration by anyone other than qualified, trained personnel; or to damage resulting from inadequate packaging in shipping the pump to CME or its designated representative. If, after inspection, CME or its designated representative is unable to identify a problem, CME or its designated representative reserves the right to invoice purchaser for said inspection. This Limited Warranty is the sole and entire warranty pertaining to CME’s products and is in lieu of and excludes all other warranties of any nature whatsoever, whether stated, or implied or arising by operation of law, trade, usage or course of dealing, including but not limited to, warranties of merchantability and warranties of fitness for a particular purpose. Purchaser expressly agrees that the remedies granted to it under this limited warranty are purchaser’s sole and exclusive remedies with respect to any claim of purchaser arising under this Limited Warranty. Managing Director Caesarea Medical Electronics Ltd.

0344

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1.9 Pump inspection and unpacking Inspecting the pump before use Remove the T34™ syringe pump and accessories from the packaging and inspect for damage during shipment or storage. Make sure you have the following items: o T34™ syringe pump o Operations Manual (hard/electronic copy) If any items are missing or damaged, contact your supplies department. WARNING: Visually inspect packaging and contents before each use. WARNING: Do not use the T34™ syringe pump and accessories if there are any obvious signs of damage. Return for inspection by authorised service personnel.

Accessories (if purchased) o Alkaline 9V batteries o Lockbox (supplied with two keys) o Carry Pouch (re-usable or disposable) If any items are missing or damaged, contact your supplies department. WARNING: Only use accessories designed for the system. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the T34™ syringe pump distributor.

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SECTION 2: DISPOSABLES AND ACCESSORIES 2.1 Syringe brands and sizes The T34™ syringe pump is programmed to recognize most commonly used syringes from 2 mL to 50 mL. Luer lock syringes should always be used to ensure secure connection of the infusion set and syringe. For homecare applications it is recommended that all but the brand of syringe in regular use are disabled per the technician menu to prevent accidental selection of the incorrect brand during set up . WARNING: DO NOT USE Slip-tip syringes. Luer Lock syringes must always be used to ensure secure connection of the infusion set and the pump is calibrated to Luer Lock. Failure to do so may result in under or over infusion as the dimension of some manufacturers slip-tip syringes differ from their own Luer Lock variants. It is recommended that all but the brand of syringe in regular use are disabled via the BodyComm™ Communication Software to prevent accidental selection of the incorrect brand during set up. Should the need arise to program the T34™ syringe pump to operate with a manufacturer and/or brand other than one of those listed above you should consult either your local medical engineering department or CME Ltd. Technical Services.

Default syringe brands configured for use • • • • •

Braun Omnifix 2, 5, 10, 20, 30 & 50mL BD Plastipak 3, 5,10, 20, 30l & 50mL Monoject 6, 12, 20, 35 & 50mL Codan/Once 2.5, 5, 10, 20, 30 & 50mL Terumo 5, 10, 20, 30 & 50mL

It is possible to disable default syringes from the memory or replace them with one not listed above. This procedure is not detailed in this manual as it should only be undertaken by trained, certified service centres or biomedical engineers. Please consult a biomed engineer or your local T34™ syringe pump distributor should this need arise.

Syringe volumes Due to the physical length of the screw that drives the syringe plunger forward there are limits to the maximum amount that can be delivered from larger syringes and on some smaller syringes there is an undeliverable volume that will be left in the syringe once the actuator has driven to the zero position. NOTE: Braun 2mL, Codan 2.5mL and Monoject 6mL syringes exhibit a slight undeliverable volume of 0.1mL due to their design. The T60 will display the volume as “VOLUME 2.4 (of 2.5mL)”. In this example the pump can only deliver 2.4 of the 2.5mL in the syringe and when the pump has driven as far forward as possible 0.1mL will be left in the syringe. WARNING: Some manufacturers have several brand names within their ranges (e.g. Braun Omnifix and Braun Perfusor). Only use the brands named above with the T60 as failing to do so could result in an under or over infusion.

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Maximum fill volume for syringes 20mL to 50/60mL Syringe brand Monoject

20mL 18.7mL

Syringe size 30mL -

50/60mL 33.6mL

Braun Omnifix

20mL

24.4mL

37.7mL

BD Plastipak

18mL

23.5mL

34.9mL

Terumo

18.6mL

24.5mL

38.0mL

Codan

20mL

22.5mL

35.9mL

Time to alarm from occlusion The occlusion times to alarm for the T34™ syringe pump are in accordance to the table below. All the tests were performed using a CME extension set, 100-172S and a BD Plastipak syringes filled with water.

Manufacturer

Size 5ml 10ml

BD Plastipak 20ml 50/60ml

Time to alarm from occlusion Rate 300mmHg

600mmHg

900mmHg

1ml/h

11'

11'50"

14'30"

100ml/h

7"

10"

10"

1ml/h

17'30"

20'25"

31'30"

100ml/h

8"

11"

13"

1ml/h

29'30"

42'30"

58'45"

100ml/h

19"

20"

23"

1ml/h

46'

54'30"

117'

34"

36"

100ml/h 28" The tolerance for the BD Plastipak 50/60mll syringe is ±25% or ± 100mmHg The tolerance of the BD Plastipak 5ml syringe is ±25% ±200mmHg

2.2 Administration sets Introduction The T34™ syringe pump can be operated with any extension set with a Luer connection. However, it is recommended, to optimise system accuracy and performance, that proprietary sets from CME Ltd. are used. All CME Ltd. sets have siphon/free flow protection.

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Features and characteristics Feature Materials Tubing

Slide Clamp Check valve (one-way valve)

Description The administration sets are manufactured using PVC materials that do not contain latex or Di (2-ethylhexyl) phthalate (DEHP). Micro-bore: require small priming volumes. Anti-kink: to prevent kinking or occlusion particularly in ambulatory configuration. Various lengths available. Clamps: to prevent fluid flow to patient (optional on some sets). All CME Ltd. syringe extension sets contain a combination check valve to prevent uncontrolled flow of fluid either towards or from the patient. The syringe extension set with pressure activated anti-siphon/anti-reflux valve reduces the potential for gravity flow and backflow (backtracking). The pressure-activated anti-siphon valve requires pressure to open. The pump occlusion pressure setting may require adjustment to prevent occlusion alarms. The combination check valve enhances pump functioning by:  Preventing siphoning (free-flow) in the event the set is detached from the pump or mechanical malfunction  Preventing reflux (back-flow) in the event several infusion pumps are connected simultaneously to the same patient.

Luer Lock end connector

The administration set is designed to be connected to Luer Lock syringes. Luer Lock syringe allows a needle to be twisted onto the tip and then locked in place. This provides a secure connection and prevents accidental removal.

Color-coded sets

Color coded sets are available as a visual aid to assist users in identifying a drug delivery route: o Clear sets may be used for any drug delivery route o Blue sets normally indicate intravenous drug delivery route o Yellow sets indicate epidural or intrathecal drug delivery route

WARNING: Ensure the administration set is NOT connected to the patient during priming. WARNING: A kinked/occluded infusion line may impair the operation and accuracy of the pump. Before operation, verify that the infusion line is not kinked or occluded. NOTE: Manufacturing data for set durability and accuracy of proprietary sets is up to 72 hours. Follow local guidelines for set use.

Advisory warnings and notes for syringes and administration sets: WARNING: Never prime or purge a set with the extension set attached to the patient. WARNING: Component damage may occur if the set is not correctly attached to the syringe. Assure all connections are secure: DO NOT over-tighten. This will help minimise leaks, disconnection and component damage. WARNING: Disposables (as with any infusion) used with the syringe pump must be compatible with the drug/fluid being delivered. Check with the manufacturer of the disposables before use. Consult the fluid or drug manufacturer’s information for precautions, guidelines, and instructions for preparation and use of disposables. WARNING: Replace the syringe and/or set in accordance with local guidelines. Software Version NCAT / NCATBOL

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WARNING: Use good aseptic technique when filling the syringe and priming the administration set. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components and do not re-use singe use sets. WARNING: Syringes and administration sets should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within, in accordance with the hospital/homecare provider’s disposal practices.

2.3 Battery power supply Battery types and use WARNING: Ensure you use the appropriate batteries for the T34TM Ambulatory Syringe Pump Always use a 9-volt alkaline disposable battery. CME Ltd. recommends to always use a battery carrying the international marking code 6LR61. Batteries from different manufacturers can vary by 2mm in length, and shorter batteries may be at risk of losing connection. Therefore, to minimize the risk of losing battery connection, CME Medical recommends using the Duracell® brand 9-volt (6LR61) battery in your T34TM pump, as this was the battery validated for use with the pump WARNING: Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the T34™ syringe pump distributor. Batteries marked 6LP3 are not recommended for use with the T34™ syringe pump. 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. WARNING: There is some variation in size between different brands of batteries. Never try to force a battery into the battery compartment as this may damage the battery contacts. Incorrectly aligning the battery contacts will not cause any harm to the battery or the pump. Remove the battery and re-align the contacts.

Battery dimensions and battery fitting Disposable battery dimensions can vary between different brands of batteries (either larger or smaller than the standard size). Some brands of battery will not fit into the battery compartment area as the dimensions are too large and other battery brands may be smaller and appear loose in the battery area, which can result in movement within the battery housing with possible loss of connection/power. If a battery is too large to fit, use a different battery brand. If a battery within the T34™ housing appears loose careful adjustment of the battery connections may be needed to move them back to the correct position. Return the pump to your service department for adjustment of the connections.

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Battery compartment connectors in correct position

WARNING: Check that the battery fits securely into the battery housing. Never try to force a battery into the T34TM pump as this may damage the contacts. If you feel the battery is loose, you should not use the pump. If you have concerns about battery fit, arrange for the syringe pump to have a maintenance check by your own maintenance team or your third-party provider.

Battery life Factors that affect battery life include: o Pump settings o Infusion rate o The number of interventions that occur (e.g. stopping/starting infusions, manual movement of actuator and backlight activation) o The number of key presses that occur o Frequency of LED green light flashing o Battery chemical and constructive compositions The pump battery meter displays battery life remaining as a percentage (%) o When the battery power is low a low battery alert will activate o When the battery power is almost depleted, an end of battery alarm will activate o The end of battery alarm will continue until the user presses YES to confirm or the battery power if fully depleted. Refer to alerts, alarms and troubleshooting section for further information.

Indications to change a battery Average battery life is approximately three to five days. Based on five days of normal pump use, for a battery with 100% power, battery power consumption would average 20% per day. Guidance for battery changing may vary for different areas according to local policy and where the pump is to be used and who is managing the pump (healthcare professional or patient as end user). If the pump is being managed in an environment where designated personnel are available at all times to change a battery if necessary, the low battery alert can be used as an indication to change a battery. If the pump is being managed in an environment where designated personnel are unavailable to change a battery if necessary, the following rule applies: To ensure delivery of a 24-hour infusion, ensure that there is a minimum percentage available at the start of the infusion.

Battery fitting and removal Inserting and removing a battery The battery should fit securely to prevent loss of battery to pump electrode contact. WARNING: DO NOT use scissors or metal objects to remove a battery.

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Inserting and removing a battery The battery should fit securely to prevent loss of battery to pump electrode contact. WARNING: DO NOT use scissors or metal objects to remove a battery.

To insert the battery into the pump: 1. Slide the compartment cover off at the back of the pump.

2. Ensure that the battery and the battery +/- contacts are aligned with the label inside the compartment

3. Start by inserting the battery into the compartment by placing the bottom of the battery in the compartment first. Ensure the bottom of the battery rests on the foam pad.

4. Complete insertion by pushing the top of the battery down and ensure it is correctly inserted in the compartment. 5. Slide the cover back on.

WARNING: Check that the battery fits securely into the battery housing. Never try to force a battery into the T34TM pump as this may damage the contacts. If you feel the battery is loose, you should not use the pump. If you have concerns about battery fit, arrange for the syringe pump to have a maintenance check by your own maintenance team, your third-party provider or CME Medical. Do not remove the foam pad. If the foam pad falls out, please follow the instructions provided in the technical service bulletin and replace the foam pad. The T34 pump should not be used without a foam pad. If you have any questions or concerns, please contact your healthcare provider.

To remove the battery from the pump: a. Slide the compartment cover off at the back of the pump. b. Remove the battery c. Slide the cover back on.

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2.4 Lockbox Uses and features Lockboxes are designed to help protect the syringe from displacement and/or tampering. Lock boxes are made from Polycarbonate due to its high impact, temperature resistance and optical properties, durability tests confirm that the overall design and construction of the T34™ syringe pump lock box ensures that they are fit for their intended purpose of protecting the T34™ syringe pump from damage caused through normal daily use and drops within the accepted normal range of one meter.

Types and sizes Lockbox for commonly used syringes up to 30mL

o o o

Lockbox for commonly used syringes up to 50/60mL

Lockboxes are available in clear polycarbonate and with a yellow transparent tinge. A clear lockbox can be used with any drug delivery route A yellow tinged lockbox denotes epidural or intrathecal drug delivery route

NOTE: lockboxes are designed for the use with CME Ltd. administration sets. If using an alternate brand of administration set with a commonly used 30mL syringe the set design may prevent the lockbox from fully closing and locking. Refer to your local sales representative or CME Ltd. website for information on lockbox types, codes and costs.

Using the lockbox When ready, place the pump into the lockbox +/- carry pouch: 1) Open the lockbox using the standard key that operates all T34™ lockboxes. 2) Place the pump into the lockbox so that the LCD display and keypad line up with the cut out opening. 3) Close the lockbox, guiding the administration set out of the slot at the side of the top section of the box. 4) Place the lockbox (or syringe pump if the security of the lockbox is not required for your practice) into the carry pouch and secure to the patient.

2.5 Carry Pouches Pouch use and types Disposable (single patient use) and re-useable (washable) pouches are available. Refer to your local sales representative or CME Ltd. website for information on types, codes and costs. Refer to Section 7 for re-usable pouch cleaning instructions.

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Use of pouches for protection of pumps during transportation WARNING: The T34™ syringe pump must always be used in a CME Ltd pouch or similar receptacle if used in direct sunlight. If the pump is exposed to direct sunlight, it may affect functionality.

Using the pump with a CME Ltd. pouch or similar receptacle during transportation or patient ambulation whilst the pump is infusing protects the pump functionality and the medication in the syringe from exposure to direct sunlight. The pouch will also protect the pump from damage or syringe displacement. When using the CME Ltd re-useable (washable) pouch, it is possible to access the screen and keypad of the device during infusion by lifting the velcro flap of the pouch whilst the pump remains in the pouch. When using either a CME Ltd re-useable (washable) or disposable (single patient use) pouch it is possible to remove the forward part of the device during infusion from the pouch to inspect the syringe without removing the rear section of the device. CME Ltd pouches can be carried on the shoulder or around the waist for convenience.

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SECTION 3: PUMP FEATURES AND DESCRIPTION 3.1 Overview The T34™ syringe pump is a small, lightweight, robust, battery powered infusion pump. It is equally suitable for adults or paediatric use. The T34™ syringe pump may be used for a variety of clinical applications to deliver indicated medications via common infusion routes, including intravenous and subcutaneous.

Safety features o o o o o o

o o o o

o o o

Accommodates a range of commonly used syringe brand and sizes Three-point syringe detection system Access code protected areas for pump configuration Lockable infusion program Capable of small mL/hour rate delivery Post Occlusion Bolus Reduction System Configurable occlusion pressure setting LCD display screen with backlight Green LED indicator light to indicate if infusion is in progress Comprehensive range of alerts and alarms Keypad lock Event Log Lockable lockbox

3.2 Pump description Top of pump: syringe fitting

No.

Area

1. 2. 3. 4. 5. 6.

Barrel clamp arm sensor Collar sensor Plunger sensor Lead screw Actuator Guide rails

Function Detects syringe barrel loading and secures syringe in place Detects correct loading of the syringe collar Detects correct loading of the syringe plunger Moves actuator Drives the syringe plunger to deliver syringe contents The two guide rails support the actuator position

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Front of pump: keys and display screen

No.

Area

Function

1.

INFO key

2.

UP arrow key

3.

DOWN arrow key

4.

YES/START key

5.

NO/STOP key

6.

FF (Forward key

7.

BACK (Reverse) key Moves actuator backward when no syringe is in place and barrel clamp arm is down

8. 9.

ON/OFF key LED light

10. LCD display screen

a) repeated presses during infusion will display infusion summary and battery level b) when pump paused, accesses the main (Info) menu c) activates/deactivates keypad lock a) scrolls between options b) increases infusion parameters during programming/titration a) scrolls between options b) decreases infusion parameters during programming/titration a) Confirms selection b) Starts infusion a) stops infusion b) takes user back a step during programming a) moves actuator forward when no syringe in place and the barrel clamp arm is down b) accesses purge function (if enabled)

Powers the pump on and off A green indicator lights: (a) during system self-test (b) intermittently to indicate infusion delivery A red indicator lights: (a) continuously to indicate an alarm state (b) when pump paused/on stand-by mode Displays pump and infusion status, programming choices and instructions

Software Version NCAT / NCATBOL

100-090SM Rev.04

19

Back of pump: battery area and pump markings

No.

Area

Function

1.

Pump information and symbols

Labelling (including universal symbols) identify a device, its manufacturer, and communicates information on safety, use and performance.

2.

Battery fitting area

Includes instructions for inserting the battery into the correct position.

3.

Docking station communication connector

When the pump is placed into a docking station, provides connection to PC/ BodyComm™ Communication Software

3.5 Event Log What is the event log? The event log shows a complete time and date stamped record of the last 512 pump events along with a record of pump status (volume infused, rate, etc.) at the time of the event. Event log data cannot be deleted or altered and it is not patient specific i.e. the 512 events are likely to span multiple patients treated with that particular pump. Each event is assigned a new number and the pump stores the last 512 in memory. For event s over 512, the pump deletes the oldest event in the log each time a new event occurs. For example, after some time, the first event to appear when you enter the events history may be number 754. This means there have been 754 events in this pumps life and events 242-754 are stored in this history. The pump deletes the oldest event in the log each time a new event occurs. Events recorded include hourly self-testing when an infusion is running and certain key presses. When the pump is infusing, the pump will record pump status every hour irrespective of any key presses. The event log can be viewed via the pump or BodyComm™ Communication Software and a print out of events can be obtained using BodyComm™ Communication Software.

Event Log access and navigation The event log cannot be accessed whilst an infusion is running, if necessary, stop the infusion and remove keypad lock. Press the INFO key: Info Menu

Battery Level

2. Use ↓/↑ keys to scroll to “Event Log”

Info Menu

3. Press YES

Event Log

Select ↓/↑, Press YES

Select ↓/↑, Press YES

The most recent event displays:

Software Version NCAT / NCATBOL

100-090SM Rev.04

20