T34L-PCA (TPCA) PCA Operator Manual SW Ver PCAEU March 2015 Rev 00

TABLE OF CONTENT SECTION 1: GENERAL INFORMATION ... 4 1.1 Preface ... 4 1.2 About this manual ... 4 1.3 Advisory terms and operating precautions... 4 1.4 Intended use ... 6 1.5 Contraindications ... 6 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 Lockbox ... 13 2.4 Carry pouches ... 13 ... 14 SECTION 3: PUMP SYSTEM FEATURES AND DESCRIPTION ... 14 3.1 What is the T34L-PCATM Pain Management Syringe Pump? ... 14 3.2 Pump description ... 14 3.3 Event log... 17 3.4 Post Occlusion Bolus Reduction System (POBRS) ... 19 3.5 Mains power supply and internal battery... 20 4.1 T34L-PCATM software description ... 21 4.3 Bolus functionality ... 25 4.4 Keep vein open (KVO) ... 27 4.5 Purge ... 28 SECTION 5: PUMP CONFIGURATION ... 29 5.1 User access codes ... 29 5.2 Pump configuration ... 30 5.3 Pump menu`s ... 30 5.4 Instructions for reconfiguring protocols via the pump ... 32 SECTION 6: STARTING A NEW INFUSION ... 37 6.1 User instructions for starting a new infusion... 37

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SECTION 7 MONITORING AND MANAGING INFUSIONS ... 46 7.1 Pump and infusion safety checks ... 46 7.2 Stopping/pausing the infusion and powering off ... 47 7.3 Keypad lock ... 48 7.4 Program protection and “Resume” ... 49 7.5 Basal rate titration during delivery ... 49 7.6 Patient bolus lockout time titration ... 50 7.7 Patient bolus dose titration during delivery ... 51 7.8 Delivering a clinician activated bolus ... 51 7.9 Alerts, alarms and troubleshooting ... 52

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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

TM

The operator must be thoroughly familiar with the T34L-PCA Pain Management 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 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 TM operating T34L-PCA Pain Management 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 TM before operating the T34L-PCA Pain Management Syringe Pump.

Operating precautions and warnings 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.

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TM

o

Although the T34L-PCA Pain Management Syringe Pump has been designed and manufactured to exact specifications, it is not intended to replace trained personnel in the supervision of infusions. o 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. o 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. o 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. o 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. o 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. o 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. o 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. TM The T34L-PCA Pain Management Syringe Pump system should be operated within a temperature range o o o o of +15 C to +45 C (+59 F to + 113 F). Operation at temperatures outside this range may affect accuracy.

Infusion precautions and warnings Carefully read and follow accompanying set instructions for priming the set and the recommended set change interval. o 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. o 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. o 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. o 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. o 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.

General precautions and warnings TM

o

The T34L-PCA Pain Management 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

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o

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.

1.4 Intended use TM

The T34L-PCA Pain Management Syringe Pump is intended to be used for any common infusion route including central/peripheral venous or subcutaneous. To minimize risk when administering infusions, dedicated administration sets are available. Colour coded sets are available to denote the intended route of drug administration. Please ask your local representative or contact us direct for further details. Please ensure the pumps are only used by, or under the supervision of trained medical staff. WARNING: Administration of drugs other than those indicated for IV use could result in serious injury to the patient.

1.5 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

1.6 System symbols

TM

The following symbols are used on the T34L-PCA Pain Management 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. Symbols

IPX1

Description Degree of protection against ingress of water.

Type of protection against electric shock - Class II equipment.

Attention, consult the accompanying 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 battery in municipal waste. Symbol indicates separate collection for battery is required.

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Type CF applied part.

Date of manufacture.

SN

Serial number.

Manufacturer.

Expiry date (consumables).

LOT

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

STERILE EO

Sterilized with Ethylene Oxide. (Consumables).

1.7 Syringe pump specifications TM

Type

T34L-PCA Pain Management Syringe Pump Syringe Pump with motor driven linear actuator, pulsed motion (60 pulses per mm).

Basal Rate

0.1 to 650mL/h.

Actuator travel

c. 107mm available.

Syringe sizes

2mL to 60mL (most commonly used manufacturers).

Pump Accuracy

± 2 %.

Occlusion Pressure

100 - 1500mmHg. Max actuator force 50N (5Kgf).

Battery

Rechargeable Li-Polymer 7.4V, 1800mAh.

Battery Life

100 full deliveries depending on infusion and set up parameters.

Indicators

Graphic LCD display (128x 64 pixels with backlight), dual colour operation LED to denote infusion and alarm status and keypad.

Alarms

When a problem is detected, the pump displays the following alarm messages, sounds an audible alarm and the red LED lights:  Occlusion or Syringe Empty  Syringe Empty  Near End (alert)  End Battery  Locking Cover Open

Dimensions

 Low Battery (alert)  Pump Paused Too Long  Syringe Displaced  Syringe Error

38X55X190mm (6.5 x 0.9 x 1.8 inches).

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Classification

Type CF Equipment.

Housing

Polycarbonate ABS (fire retardant).

Weight

400 gr with battery.

Electrical Safety

Complies with: EN 60601-1 (Medical Electrical Equipment Safety) IEC 60601-2-24 (Infusion pumps and controllers) IEC 62304 (Medical Device Software – Software Life Cycle Processes)

Standards

Manufacture in accordance to ISO 9001 and ISO 13485. CE marked (In accordance with the Medical Devices Directive 93/42/EEC).

EMC

IEC 60601-1-2 (EMC).

Environmental Specifications

Non-Operating Conditions (Transportation and Storage): o o o o  Temperature: -25 C to 50 C (-13 F to + 122 F)  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: o o o o  Temperature: +15 C to +45 C (+59 F to + 113 F) o  Humidity: 20 % to 85% R.H. at +40 C, non-condensing  Air pressure: 70kPa to 110kPa

1.8 Limited warranty TM

The T34L-PCA Pain Management Syringe Pump has been carefully manufactured from the highest quality components. Caesarea Medical Electronics Ltd (CME Ltd.) guarantees the pump against defects in material and workmanship for twelve (12) months from date of purchase. CME Ltd.`s obligation, or that of its designated representative under this Limited Warranty, shall be limited, at CME Ltd.`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 above-mentioned 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 Ltd. or its designated representative within thirty (30) days after such defect is discovered. The defective pump should be sent immediately to CME Ltd. or its designated representative for inspection, repair or replacement. Shipping costs are the purchaser’s responsibility. Material returned to CME Ltd. or its designated representative should be properly packaged using CME Ltd. 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 Ltd. or its designated representative. If, after inspection, CME Ltd. or its designated representative is unable to identify a problem, CME Ltd. or its designated representative reserves the right to invoice purchaser for said inspection.

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This Warranty is the sole and entire warranty pertaining to CME Ltd.’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 Warranty.

Caesarea Medical Electronics Ltd 16 Shacham street Industrial Park Caesarea North P.O.Box 4294 Caesarea 38900, Israel Email: [email protected] www.cme-infusion.com

0344

1.9 Pump inspection and unpacking Inspecting the pump before use TM

Remove the T34L-PCA Pain Management Syringe Pump and accessories from the packaging and inspect for damage during shipment or storage. Make sure you have the following items in the pump box: TM T34L-PCA pump Pump mains power charger Patient Bolus handset Pole mount clamp Operation manual If any items are missing or damaged, contact your supplies department. TM

WARNING: Do not use T34L-PCA Pain Management Syringe Pump if there are any obvious signs of damage. Return for inspection by authorised service personnel.

Optional accessories may include (if purchased): o Lockbox o Disposable (single patient use) pouches o Reusable (washable) pouches

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SECTION 2: DISPOSABLES AND ACCESSORIES 2.1 Syringe brands and sizes TM

The T34L-PCA is calibrated to operate with the most commonly used Luer lock syringe brands and programmed to recognise most commonly used syringe sizes ranging from 2 mL to 50/60 mL. 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. TM

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. TM Should the need arise to programme the T34L-PCA 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 Syringe brand Monoject Braun Omnifix BD Plastipak Terumo Codan Custom brand

2mL

2.5mL

3mL

5mL

6mL



10mL





12mL

20mL





30mL

35mL

50mL



















































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 TM to their design. The T34L-PCA 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 TM Perfusor). Only use the brands named above with the T34L-PCA as failing to do so could result in an under or over infusion.

Time to alarm from occlusion

TM

The Time to Alarm from Occlusions for the T34L-PCA syringe pump are in accordance to the table below. All the tests were performed using a CME Ltd. extension set, 100-172S and a BD Plastipak syringes filled with water.

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Time to Alarm from Occlusion Manufacturer

Size 5ml 10ml

BD Plastipak 20ml 50/60ml

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'

100ml/h

28"

34"

36"

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 Administration sets TM

The T34L-PCA can be operated with any extension set licensed for a range of infusion routes that will connect to a Luer Lock syringe. However, it is recommended, to optimise system accuracy and performance, that proprietary sets from CME Ltd. are used. All CME Ltd. syringe sets have siphon/free flow protection.

Features and characteristics Refer to local policy for the specific brand of administration set and cannula to use with the pump. CME Ltd. administration sets incorporate the following features: o Latex-free o Micro bore anti-kink tubing to prevent occlusion o Colour-coded to aid identification of administration route o Small priming volume Feature Materials Tubing

Slide Clamp

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 tube lengths are available. Clamps are used to prevent fluid flow to patient (optional on some sets).

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Antisiphon/Back check valve

Luer Lock end connector

All CME Ltd. syringe extension sets contain a combination anti-siphon and back check valve. 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 siphonage (free-flow) in the event the set is detached from the syringe/pump or mechanical malfunction  Preventing reflux (back-flow) in the event several infusion pumps are connected simultaneously to the same patient. The administration set is designed to be connected to Luer Lock syringes only. 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.

Colour-coded sets

Colour 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 Refer to company website for the most current list of codes and prices. 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. 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. 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.

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2.3 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 TM and construction of the T34L-PCA syringe pump lock box ensures that they are fit for their intended purpose of TM protecting the T34L-PCA 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 50/60mL o Lockboxes are available in clear polycarbonate o A clear lockbox can be used with any drug delivery route o The lockbox can be placed in a disposable (single patient use) and re-useable (washable) pouch o The pump and lockbox can be attached to a pole mount if required. 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: TM 1) Open the lockbox using the standard key that operates all T34L-PCA syringe pump 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 front 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.

2.4 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.

Use of pouches for protection of pumps during transportation TM

WARNING: The T34L-PCA Pain Management 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 SYSTEM FEATURES AND DESCRIPTION 3.1 What is the T34L-PCATM Pain Management Syringe Pump? TM

The T34L-PCA Pain Management Syringe Pump is a small light and compact ambulatory syringe pump, which can be operated from mains power or rechargeable battery. The size and weight of the pump makes it ideal for ambulatory or pole mounted use in either a hospital, homecare or out-patient setting. It is equally suitable for adults or for paediatric use. Key features include: o Authorised user access code protection to prevent accidental or unauthorised protocol changes. o Up to 6 protocols can be configured into the pump, with soft and hard limits to suit the drug delivery. o Weight-based protocols can be configured. o Lockbox and lockable keypad to prevent tampering. o The Event log which automatically records accurate and reliable data on pump use. o Three-point syringe detection enabling the pump to identify all commonly used (or programmed) syringe brands and size. o Automatic bolus rate adjustment feature (patient bolus and clinician bolus). o Residual patient bolus feature. o Post Occlusion Bolus Reduction System (POBRS).

3.2 Pump description Top of pump: syringe fitting

No. 1. 2. 3.

Area Barrel clamp arm sensor Collar sensor Plunger sensor and actuator

4. 5.

Lead screw Guide rails

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Function Detects and secures syringe barrel. Detects correct loading of the syringe collar. Plunger sensor detects and secures syringe plunger Actuator drives the plunger sensor to deliver syringe contents. Moves actuator forward and backwards. The two guide rails support the actuator position.

Ref.: OPR00087Rev. 00

Front of pump

5

7

6

9 4

10

2 8 11

1

3

No. Area Function 1. ON/OFF key Powers the pump on and off 2. Operation LED light 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 the pump is in stand-by mode 3. FF (Forward) key a) Moves actuator forward b) Accesses purge function (if enabled) 4. BACK (Reverse) key Moves actuator backward 5. UP (+) key 6. DOWN (-) key 7. STOP/NO key 8. START/YES key 9. INFO key

10. 6 line LCD screen 11. Infra-red port

a) Scrolls between options Scrolls between options a) Stops infusion b) Takes user back to previous screen a) Confirms selections b) Starts infusion 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 Displays pump and infusion status, programming choices and instructions TM For connecting dongle to Bodycomm communications software

Back of pump: battery area and pump markings

No. 1. Pump label

Area

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Function Label includes universal symbols, device identity, manufacturer, and communicates information on using the pump safely. Ref.: OPR00087Rev. 00

2. 3.

DC mains power lead connector Pump locator pins

Power lead connection (diagram shows power lead in position). For fixing pump pins to pole mount.

Side of pump

1

No. Area 1. Patient bolus cable connector

Function Connects patient bolus cable to the pump

Pole mounting unit

No. 1. 2. 3. 4.

Area Locator holes Pole mount locking catch Adjusting screw Adjusting screw location area

Function To fix pole mount to pump pins. To lock and release the pole mounting unit to the pump. For fixing the pole mount unit to the drip stand (vertical position). The adjusting screw can be moved here for horizontal pump positioning.

Attaching the pole mounting unit to the drip stand a. Position the pole mounting unit onto the pole as shown. b. Turn the adjusting screw to fix the mount securely.

Adjusting screw

Attaching the pole mounting unit to the pump A. Pull up the locking catch (1) on the pole mounting unit and keep it held up. B. Insert the pump locator pins (2) into the pole mount locator holes (3) and position the pump into place. c. Release the locking catch (1).

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Attaching the mains power lead to the pump a. Insert the mains power lead into the pump as shown.

Patient bolus cable The user action required to deliver a bolus dose is by pressing and releasing the bolus button, actual delivery of the bolus dose commences on release of the bolus button. The coded hand switch has default settings for minimum and maximum pressing times and minimal pressing interval. These can TM be changed via BodyComm Communication software. Patients can easily identify when a bolus is available or not available and when a bolus is being delivered. The patient bolus cable connects to the pump bolus cable connector on the side of the pump.

Equipment safety checks In clinical settings handsets/cables over time can be damaged by excessive force. As such handsets, and the attached cables, are part of the system most exposed and susceptible to damage. All CME Ltd. infusion pumps feature software protection to mitigate the impact of bolus handset damage, thereby reducing the incidence of unrequested activation when a handset or cable is damaged. It is good practice to inspect medical equipment and related accessories between patients and certainly immediately before use (e.g. whilst setting it up on the patient). One of the issues with damage to cables or internal electrical components is that visual inspection alone will not always be able to identify this type of failure. Equipment safety checks for healthcare professionals Prior to connecting the remote bolus handset cable to the pump, press the handset button - you should feel a click. If no click is felt when the button is pressed remove the remote bolus handset from use and return it to your medical engineering department or its authorised service provider for inspection. When instructing patients If, during use, the patient experiences or sees any of the following, they should inform their clinician immediately: o They press and release the button to request a bolus (or register an attempted bolus depending on local policy) and feel no click and the pump does not deliver a bolus dose and/or emit a beep. o They hear the pump emitting beeps (indicating bolus delivery or attempt) when they are not holding the handset and/or pressing the button. o They see the handset exposed to anything that may have damaged it (stood on by a relative, trapped in bedframe, cable “tugged” violently, etc.) o They notice any part of the system damaged (e.g. wires exposed, housing cracked, etc.)

3.3 Event log The event log shows a complete time and date stamped record of the last 512 pump events along with a SW Version PCAEU_010315

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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. Events recorded include hourly self-testing when an infusion is running and key presses. When the pump is infusing, the pump will record pump status every hour irrespective of any key presses. NOTE: 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. The event log can be viewed via the pump or BodyComm™ Communications Software and a print out of events can be obtained using BodyComm™.

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. 1. Press the INFO key: Info Menu

Info Menu

Battery Level

2. Use +/- to scroll to “Event Log”

Event Log

3. Press START/YES

Select +/-, Press YES

Select +/-, Press YES The most recent event displays: Event No: 1854 27.07.2011 16:01 Start Infusion Press INFO - Details

Line 1: Event Number Line 2: Date and time of event Line 3: Operating state Line 4: View details on this event

Use +/- to scroll up or down events of interest or, press INFO to display detailed information for the event

VI 1.03ml VTBI 14.35ml Rate 0.64ml/h 30ml BD Plastipak

VI = Volume infused VTBI = Volume to be infused Rate = mL/hour rate 30mL BD Plastipak = Syringe brand and size confirmed

Travel 2.73mm/ml 1N (0mmHg) =18mA 28N (540mmHg) =83mA Motor Current 0 mA Occlusion 720mmHg Battery 7.8V

Travel = Distance of actuator travel (mm) to deliver 1mL (for the syringe size and brand confirmed) 1N = Minimum actuator travel force (related to start up motor movement) 28N = Maximum actuator travel force (related to start up motor movement) Motor Current = motor current level in mA Occlusion = pump occlusion alarm setting Battery = battery voltage

Use + or – key to display further information

To return to the previous screen, press NO. NOTE: The information that displays when INFO is pressed will vary depending on the operational status of the pump. Some events may only record one or two parameters; other events record numerous parameters. Other event examples are: Switched ON

Syringe Removed

Anti-bolus Reverse

Keypad Lock ON

Switched OFF

Occlusion / End

Stop Infusion

Keypad Lock OFF

Purge

Pump Operating

System Error

Volume Change When INFO is pressed: SW Version PCAEU_010315

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NOTE: Other events may be recorded relating to technical information, refer to the technical service Manual. NOTE: The pump does not automatically change for daylight saving, the date and time can be updated manually via the pump Change Set Up Menu or via the BodyComm™ Communications Software.

3.4 Post Occlusion Bolus Reduction System (POBRS) What is the Post Occlusion Bolus Reduction system? During an occlusion, the pressure in the downstream section of the line and/or inside the syringe can increase above the occlusion pressure defined in pump settings. When the pump alarms the user must check the line and attempt to clear the occlusion. During an occlusion the pump’s Post Occlusion Bolus Reduction System feature will reverse the operation of the motor and drive the actuator backwards otherwise the pressure build up could cause a surge of fluid into the patient’ on release of the occlusion. When the infusion is resumed, the user will notice that the volume to be infused (VTBI) increases and the volume infused (VI) decreases to indicate the pump back off feature and the infusion time remaining increases; this protects the mL/hour infusion rate. Following activation of the POBRS and if the user presses “YES to Resume” the infusion VTBI increases and the VI decreases to indicate the pump back off feature.

Occlusion pressure The occlusion pressure of a pump is the pressure in the system, registered at the pump, when the pump is still operating but cannot sustain the flow rate. The resultant build-up of pressure sets off the occlusion alarm. (Device Bulletin, 2010).

Occlusion and response An occlusion alarm can be activated by:  A blockage in the delivery tubing - often inadvertently caused by kinking or leaving a roller clamp or a tap closed.  A clotted-off cannula.  A partially occluded cannula - if it causes the required driving pressure to rise above the occlusion alarm level.  A very long or narrow bore cannula or/with extension line. Occlusion response is characterised in terms of three measurable parameters: 1. Pressure to alarm 2. Time to alarm 3. Bolus release when occlusion is resolved 1. Pressure to alarm If an occlusion occurs the pump attempts to maintain sufficient pressure on the fluid to cause it to flow through all restrictions and overcome any additional resistance. Although fluid is incompressible, the administration set and other components of the system have some ‘give’ (compliance) and the tubing can expand under the increasing pressure. Other components of the system, such as the bung of the syringe, become compressed. This expansion and compression takes some time to occur. 2. Time to alarm If the occlusion is present from the beginning of the infusion, the time to alarm will increase. The pressure in the pumping chamber increases from zero at the start of the infusion up to the alarm level. This is the most likely situation, as leaving clamps closed is the most usual cause of occlusions. If the occlusion occurs after the pump has stabilised at its set flow rate, the alarm time will not be unusually long as the pressure in the pumping chamber increases from the already high running pressure up to the alarm level. For example, a time to alarm with an infusion rate of 1mL/h is 16 minutes 7 seconds (PASA, 2006) SW Version PCAEU_010315

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Generally, shorter time to occlusion alarm occur with high flow rates, small syringes and good quality syringes. 3. Bolus release In the case of a complete occlusion, there is no flow to the patient whilst pressure in the system is increasing. When the occlusion is released, the build-up of fluid in the tubing can result in a bolus being delivered to the patient.

3.5 Mains power supply and internal battery Mains Power Pump operates on AC (mains) or backup battery power. Connection to wall power is recommended whenever possible.

Battery use When fully charged, batteries can provide up to 100 full deliveries depending on infusion and set up parameters. Battery life may vary depending on settings, infusion rate, and the number of times the information options/screen backlight are used. Using the pump on mains power will extend the battery life. Leaving the battery in an uncharged state for long periods will shorten its life. After the End Battery signal appears, or following long periods of storage, wait two minutes after the pump has been connected to a mains power supply before operating.

Safety checks It is good practice to inspect medical equipment and accessories between patients and certainly immediately before use (e.g. whilst setting it up on the patient). One of the issues with damage to cables or internal electrical components is that visual inspection will not always be able to identify this type of failure.

Battery and charging precautions      

Replace the battery once every two years. After the “End Battery” signal has been activated or following long periods of storage, wait 2 minutes after the pump has been connected to an AC power supply before operating. Whenever possible, use the pump connected to an AC power. This preserves the battery power supply for emergency use or for situations where the AC power is not available. The pump is protected against overcharging. In order to keep your battery fully charged connect the pump to mains power whenever possible. Blown fuses could cause a fire hazard. Replace blown fuses on the charger only with fuses of the same type and rating (see fuse values on the charger PCB). Battery charging is enabled as long as the charger cord is connected to the mains and the pump. Switching the pump off does not disconnect it from the mains. To disconnect from the mains, remove the charger cord from the mains.

WARNING: Unsafe operation may result from using improper accessories. Only use accessories designed for the system. Unsafe operation may result from using improper accessories. Use only accessories and options TM designed for this system and supplied or recommended by the T34L-PCA Pain Management Syringe Pump distributor.

Battery level checks When setting up the pump on a patient always check the battery level. To check the battery, follow one of the procedures below: o Press INFO key when the pump is stopped to access the main menu and scroll to select Battery Level, press YES to view battery meter. o During infusion press the INFO key to check Battery Level. Sufficient battery charge may vary depending on your setting, infusion rate, number of times the information options/screen backlight are used.

SW Version PCAEU_010315

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