T34 Operation Manual Rev 1.4 Oct 2011

Section 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 Section 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 Section 3 3.1 3.2 3.3 3.4 3.5 3.6

INTRODUCTION

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Pump Overview ... 3 Modes Of Operation ... 3 Intended Use ... 3 Contraindications ... 3 About This Manual ... 4 Warnings And Notes ... 4 Operating Precautions ... 4-5 System Symbols ... 6 Pump Inspection And Unpacking ... 7 Lockbox ... 7 Carry Pouches ... 7 BodyComm Communications Software ... 8 Disposable and Rechargeable Batteries ... 8 FEATURES AND FUNCTIONS

9-21

Pump Feature Recognition ... 9 Access Codes ... 10 Keypad Lock ... 10 Event Log ... 11 Post Occlusion Bolus ... 11 Syringe Brands And Sizes ... 12 Administration Sets ... 12-13 Battery Fitting ... 14 Battery Life ... 14 Powering On, Pump Paused/Stopped and Powering Off ... 14 Pump Info Menu ... 15 Pump And BodyComm Configuration ... 15 Pre-Loading, Programme Protection And “Resume/New Syringe ... 16-17 Syringe Loading, Detection And Confirmation ... 18 Lock ON, Lock OFF And Rate Modes Of Operation ... 19 Rate Change (Titration) during Infusion ... 19 Recommended Safety Checks During Infusion ... 20 Alerts, Alarms And Troubleshooting ... 20-21 KVO (keep vein open) ... 22 Purge function ... 22 MAINTENANCE, CLEANING AND SERVICE

23-24

Pump Cleaning ... 23 Lockbox Cleaning ... 23 Re-Usable Pouch Cleaning ... 23 Pump Storage ... 23 Servicing ... 24 Disposal/Decommissioning ... 24

Section 4

USER GUIDES

24-34

4.1-4.10 User Guides ... 25-34 Section 5 5.1 5.2 5.3 5.4

APPENDICES

35-36

T34 Syringe Pump Specifications ... Limited Warranty ... Contact Details ... Index ...

35 36 37 38

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SECTION 1 INTRODUCTION 1.1 PUMP OVERVIEW

The T34 is a small, lightweight, robust, battery powered infusion pump. The size and weight of the T34 makes it ideal for ambulatory use in a hospital or alternate site / homecare setting. It is equally suitable for adults or paediatric use. Safety features include access code protected areas, keypad lock and event log. The T34 syringe pump may be used to deliver indicated medications via any common infusion routes including intravenous and subcutaneous. The T34 offers 3 point syringe detection enabling the pump to identify all commonly used (or programmed) syringe brands. This feature also enables the pump to calculate the syringe volume and, depending on the mode of operation, deliver the contents over a specified duration or as mls per hour infusion therefore minimising the risk of programming errors. The sensors also activate an alarm if the syringe is removed or partially displaced during infusion.

1.2 MODES OF OPERATION

The pump can be configured (and locked) to one of three modes of operation, the default mode of operation is Lock on. The mode of operation options are: Lock on is delivering the contents of a syringe over a fixed duration (pump default 24 hours). The pump automatically calculates the ml/hour rate based on the fixed duration (lock on) and the confirmed deliverable volume. Lock off is delivering the contents of a syringe over the default duration or a duration inputted by the user. The pump automatically calculates the ml/hour rate based on the confirmed duration and the confirmed deliverable volume. Rate mode is delivering the contents of a syringe by ml/hr as inputted by the user. The pump calculates the duration from the entered ml/hour rate and the syringe volume detected by the pump.

1.3 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.

1.4 CONTRAINDICATIONS    

Infusion of blood and blood products where appropriate, consult with pump manufacturer. 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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1.5 ABOUT THIS MANUAL 

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The operator must be thoroughly familiar with the T34 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.

1.6 WARNINGS 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. 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.

1.7 OPERATING PRECAUTIONS 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 Medical 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 and 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.

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CME Medical T34 Operations Manual Rev 1.4

  

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 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. 

GENERAL PRECAUTIONS Do not use hard or sharp objects on the keypad.  Do not bathe 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. 

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1.8 SYSTEM SYMBOLS SYMBOLS

The following following symbols symbols are are used usedon onthe theT34 T34syringe syringepump pumpand andcomponents. components.Labels Labelsononthe thepump pumpororstatestatements in this manual manual preceded precededby byany anyof ofthe thefollowing followingwords wordsand/or and/orsymbols symbolsare areofofspecial specialsignificance significance and/or are intended intended to to help help you youto tooperate operatethe thepump pumpininaasafe safeand andsuccessful successfulmanner. manner. SYMBOL SYMBOL

DESCRIPTION DESCRIPTION Type Type of ofprotection protectionagainst againstelectric electricshock-Class shock-Class1111equipment equipment

Attention, Attention,consult consult accompanying accompanyinginstructions instructions

C

US

0344 0344

CSA CSA mark mark

CE CE mark markindicates indicatesconformance conformancetotoMedical MedicalDevice DeviceDirective Directive93/42/EEC 93/42/EEC Do not dispose of in municipal waste. Symbol indicates separate collection for Do not dispose of in municipal waste. Symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2002/96/EEC) NOTE: Does electrical and electronic not apply to the battery. 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 Do battery not dispose of battery in municipal waste. Symbol indicates separate collection for is required. for battery is required. The use of single-use disposable components on more than one patient is a The use ofhazard. single-use disposable components on more than one patient is a biological Do not reuse single-use disposable components. biological hazard. Do not reuse single-use disposable components. Type CF applied part Type CF applied part Date of Manufacture Date of Manufacture

SN SN SN

Serial Number Serial Number Expiry Date (consumables) Expiry Date (consumables)

LOT LOT

Lot Number (consumables) Lot Number (consumables)

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1.9 PUMP INSPECTION AND UNPACKING

Remove the T34 syringe pump and accessories from the packaging and inspect for damage during shipment or storage. WARNING: Do not use the T34 syringe pump if there are any obvious signs of damage. Return for inspection by authorised service personnel. Make sure you have the following items: T34 syringe pump (the packing box will include information on how to access the operation manual electronically). Accessories (if purchased): Alkaline 9V batteries Lockbox (supplied with two keys) Carry Pouch Rechargeable batteries and charger If any items are missing or damaged, contact your supplies department. WARNING: Visually inspect packaging and contents before each use. Do not use consumables if the packaging is in any way damaged as sterility may have been compromised. WARNING: Unsafe operation may result from using improper accessories. Only use accessories designed for the system.

1.10 LOCKBOX

The lockbox will fit most commonly used syringe brands and sizes up to 30ml. 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 lock box ensures that they are fit for their intended purpose of protecting the T34 syringe driver from damage caused through normal daily use and drops within the accepted normal range of one meter. NOTE: lockboxes are designed for the use with CME Medical 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 Medical website for information on types, codes and costs.

1.11 CARRY POUCHES

Disposable and re-useable (washable) pouches are available for optional use. Refer to your local sales representative or CME Medical website for information on types, codes and costs.

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1.121.12 BODYCOMM BODYCOMM COMMUNICATIONS COMMUNICATIONS SOFTWARE SOFTWARE BodyComm BodyComm is a PC is abased PC based software software package package which which enables enables the engineer the engineer to programme to programme youryour pumps pumps via RS232 via RS232 communication communication charger/docking charger/docking station. station. The software The software allows allows you to you save to save the setup the setup and syringe and syringe datadata and replay and replay thesethese files files on toon subsequent to subsequent pumps. pumps. BodyComm BodyComm also also enables enables the user the user to download, to download, savesave and print and print the events the events log. log. Use of Use this of programme this programme can aid canthe aidinvestigation the investigation of clinical of clinical incidents incidents and help and help ensure ensure that that all pumps all pumps are configured are configured the same the same way way without without error.error.

1.131.13 BATTERIES BATTERIES Always Always use ause 9 volt a 9 alkaline volt alkaline battery. battery. These These batteries batteries can easily can easily be identified be identified by the byinternational the international marking marking codecode 6LR61 6LR61 (a recommended (a recommended battery battery of this of type this type is theisDuracell the Duracell Plus Plus MN1604). MN1604). Zinc-carbon Zinc-carbon batteries batteries (marked (marked 6F226F22 or 6R61 or 6R61 (for example (for example a PP3) a PP3) are not are recommended not recommended for use for with use with the the T34. T34. These These batteries batteries perform perform poorly poorly and need and need to betoreplaced be replaced moremore often. often. Do not Douse notnon-alkaline use non-alkaline batteries. batteries. There There is some is some variation variation in size in between size between different different brands brands of batteries. of batteries. Never Never try totry force to force a battery a battery into into the the battery battery compartment compartment as this as may this may damage damage the battery the battery contacts. contacts. Incorrectly Incorrectly aligning aligning the battery the battery contacts contacts will not willcause not cause any harm any harm to the tobattery the battery or the orpump. the pump. Remove Remove the battery the battery and re-align and re-align the contacts. the contacts. NOTE: NOTE: Rechargeable Rechargeable batteries batteries can be canused be used with with the pump. the pump. However, However, usingusing rechargeable rechargeable batteries batteries may may slightly slightly affectaffect the accuracy the accuracy of the ofbattery the battery levellevel percentage percentage displayed displayed on the onpump the pump screen screen and may and may influence influence the syringe the syringe traveltravel calibration calibration due to duevoltage to voltage differences differences between between disposable disposable and rechargeable and rechargeable batteries. batteries.

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SECTION 2 FEATURES AND FUNCTIONS 2.1 PUMP FEATURE RECOGNITION 1. BARREL CLAMP ARM secures syringe and detects brand and size

2. COLLAR SENSOR detects correct loading of the syringe collar

3. PLUNGER SENSOR detects correct loading of the syringe plunger

4. ACTUATOR drives the syringe plunger to deliver syringe contents LCD display screen

5 FEATURE 5. INFO key 6. UP arrow key 7. DOWN arrow key 8. YES/START key 9. NO/STOP key 10. FF (Forward) key

6

7

8

9

10 11

12

13 DESCRIPTION (a) whilst infusing shows infusion summary, protocol parameters and battery level (b) when pump paused, access the main 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)

11. BACK Reverse) key Moves actuator backward when no syringe is in place and barrel clamp arm is down 12. ON/OFF key

Switches the pump on and off

13. 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 pump paused/on stand-by mode

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p”,

2.2 ACCESS CODES

The T34 has two levels of healthcare provider access code protection to prevent unauthorised changes to set up, configuration or programming. Although no access code is required to turn the pump on and run an infusion, certain settings and features may be configured and locked based on patient need. In normal use the pump user will not see these fields or be prompted for access codes. NOTE: Codes will only be provided by CME Medical to designated and authorised clinical or technical staff when they have been trained and certified in their use. No access codes are contained in this manual. A level one access code allows access to “change set up” in the pump info menu. This code is provided to fully trained (by CME Medical) and authorised healthcare professionals. A level two access code allows access to the pump technician menu. This code is provided to fully trained (by CME Medical) and authorised electrical biomedical engineering personnel. WARNING: Do not attempt to access code protected areas if you are not trained or authorised to do so. Authorised personnel should not share codes with un-authorised personnel and only give the level of code access to the designated provider for the functions they will use in their clinical practise. NOTE: Technical staff must refer to CME Medical Technical services department for access codes and information on pump configuration and training.

2.3 KEYPAD LOCK

The keypad has a locking feature that prevents unintentional powering off of the unit. As well as the ability to lock or limit certain infusion parameters or pump settings, the T34 pump allows users to lock the operation of the keypad if concerned about patients, relatives or un-trained personnel tampering with the pump. To activate the keypad lock: With the pump infusing, press and hold the INFO key down until the black graphic moving from left (OFF) to right (ON) fills completely. A beep is heard, confirming that the lock has been activated. To deactivate the keypad lock: Repeat the above procedure. The graphic will now move from right (ON) to left (OFF). A beep is heard, confirming that the lock has been deactivated.

Lock Mode OFF

ON

For safety reasons the keypad lock does not affect the operation of the START or STOP keys as users or patients unaware of how to deactivate the lock may need to STOP an infusion in an emergency and/or re-start the infusion (e.g. after clearing an alarm). The keypad lock does not affect the INFO key for infusion monitoring purposes.

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2.4 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. Events recorded are hourly self-testing when an infusion is running and key presses. 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 recently treated with that particular pump. Each event is assigned a new number and the pump stores the last 512 in memory. 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. To view the event log: Info Menu A. With no infusion running, press INFO key to access the Info menu:

Battery Level Select ↓↑, Press YES Info Menu

Event Log

B, Scroll down using the ↓ arrow to “Event Log”, press YES

Select ↓↑, Press YES C. The most recent event displays: Event No: 2635 08.10.2009 16:12 Stop Infusion Press INFO - Details

Line 1: Assigned event number Line 2: Date and time of the event Line 3: Pump event (key press) Line 4: Option to view further information on this event Use ↑/↓ arrow keys to scroll up and down to view different events

NOTE: Re: date and time stamped events, 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. D. If you want to view further technical information on a specific event press the INFO key to display the pump status at the time of this event. Use ↑/↓ arrow keys to scroll up and down to view further pump status/settings To return to the previous screen press NO

VI 0.1ml VTBI 14.50ml Rate 0.6ml/h 20 ml BD Plastipak

NOTE: Technical information for each event will vary depending on the particular event recorded.

2.5 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. If the pump is resumed/restarted following the backward movement of the actuator the user will notice that time is added to the time remaining to protect the original calculated rate. CME Medical T34 Operation Manual Rev 1.4

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2.6 SYRINGES

DEFAULT SYRINGE BRANDS AND SIZES The T34 ambulatory syringe pump 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 ml. 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. DEFAULT SYRINGE BRANDS CONFIGURED FOR USE WITH THE T34 Braun Omnifix 2, 5, 10, 20, 30 and 50ml BD Plastipak 3, 5,10, 20, 30ml and 50ml Monoject 6, 12, 20, 35 and 50ml Codan/Once 2.5, 5, 10, 20 and 50ml Terumo 5, 10, 20, 30 and 50ml 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 programme the T34 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 Medical Technical Services. 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. 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 T34 as failing to do so could result in an under or over infusion. WARNING: Braun 2ml, Codan 2.5ml and Monoject 6ml syringes exhibit a slight undeliverable volume of 0.1ml due to their design. The T34 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: Use good aseptic technique when filling the syringe and priming the giving 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.

2.7 ADMINISTRATION SETS

The T34 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 Medical are used. All sets have siphon/free flow protection.

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ADMINISTRATION LINE CODES AND FEATURES PRODUCT CODE

FEATURES

Micro set 100-172S

Syringe extension set- clear DEHP, latex free Anti kink tubing with anti-siphon valve, female luer lock Length approx 100cm, priming volume approx 0.5ml

Micro set 100-170S

Syringe extension set- clear, with 25g butterfly needle DEHP, latex free Anti kink tubing with anti-siphon valve, female luer lock Length approx 100cm, priming volume approx 0.5ml

Micro set 100-172SB

Syringe extension set – blue stripe DEHP, latex free Anti kink tubing with anti-siphon valve, female luer lock Length approx 200cm, priming volume approx 0.5ml

Micro set 100-172SE

Syringe extension set – yellow stripe DEHP, latex free Anti kink tubing with anti-siphon valve, female luer lock Length approx 200cm, priming volume approx 0.5ml

Refer to company website for the most current list of codes and prices. WARNING: Disposables must be compatible with the medicine delivered. Please check with the manufacturer of the administration set before use. WARNING: Replace the set in accordance with local guidelines. 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. 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.

2.8 BATTERY FITTING

To insert the battery into the pump: A. Slide the compartment cover off at the back of the pump. B. Push the battery into the compartment taking care to ensure that the battery + / - contacts are aligned on the label inside the compartment. C. Slide the cover back on.

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2.9 BATTERY LIFE

Depending on the infusion rate, number of key presses and pump interactions the battery life is approximately three to five days. The battery meter displays as a percentage. When the battery is near empty a pump alert will activate and at the end of the battery an alarm activates until no power remains and the pump will switch off. Refer to pages 20-21 for information on alert and alarm activation. To view the battery meter either during an infusion or when the pump is paused press the INFO key twice.

Battery Level 80%

Empty

Full

NOTE: Do not use objects such as pens, scissors or the battery cover to remove the battery.

2.10 POWERING ON, PUMP PAUSED/STOPPED AND POWERING OFF TO POWER ON A. With no syringe in place and barrel clamp arm down, press and hold down the ON/OFF key until the screen displays: B. Check and ensure that the automatic actuator movement commences (refer to page 16 for further information on Pre-Loading and screen sequences).

T34 Version XXXXXX ID: Syringe Pump

PUMP PAUSED If the user presses NO during an infusion the pump is paused (stopped) for two minutes, the LED light changes from green to red and the screen message displays: A. Either press YES to restart the infusion or No to continue pause state

Pump Paused Press YES to Start

POWERING OFF If the pump is no longer required: A. Remove keypad lock if necessary and stop/pause the infusion if running. B. Press and hold down the ON/OFF key until the graphic (moving from left to right) fills completely black , a beep is heard and the display screen power is removed.

Off Wait For Beep

C. Remove battery if the pump is no longer required. D. Remove syringe and place the barrel clamp arm down. WARNING: Before removing a syringe from a pump ensure the line is disconnected from the patient to prevent unintended drug delivery to the patient. CME T34 Operation ManualManual Rev 1.4Rev 1.4 14 Medical CME Medical T34 Operations

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2.11 PUMP INFO MENU 2.11 PUMP INFO MENU OPTION OPTION

Battery Level Battery Level Event Log Event Log Rate Setting (access code protected) Rate Setting (access code protected) Change set up (access code protected) Change set up (access code protected) Exit Exit

INFO MENU OPTIONS INFO MENU OPTIONS DESCRIPTION DESCRIPTION View battery life percentage (graph) View life percentage (graph) View battery pump event log View event logml/hr rate Lockspump the rate mode Locks the rate mode ml/hr rate Change and configure programming functions Change configure programming functions Exits Infoand menu Exits Info menu

TO ACCESS THE INFO MENU: Info Menu TO ACCESS THE INFOrunning, MENU:press INFO key to display: A. With no infusion Info Menu A. With no infusion running, press INFO key to display: B. Use the ↓/↑ arrow keys to scroll to the option required and press YES to Select ↑↓, Press YES B. Usethe theoption ↓/↑ required. arrow keys to scroll to the option required and press YES to Select ↑↓, Press YES view view the option required.

=> Battery Level => Battery Level

2.12 PUMP AND BODYCOMM CONFIGURATION 2.12 PUMP ANDofBODYCOMM A limited number settings can beCONFIGURATION configured via the pump in ”Change Set Up”, “Rate Setting” and

A limited number of Full settings be configured thebe pump in ”Change SetBodyComm Up”, “Rate Setting” and “Technician” menu. pumpcan configuration canvia only carried out via the communications “Technician” menu. Fullsoftware. pump configuration can only be carried out via the BodyComm communications docking station and PC docking station and PC Pump configuration cansoftware. be carried out via the Change Set Up and Rate Setting menus Pump configuration can be carried out via the Change Set Up and Rate Setting menus PUMP CHANGE SET UP MENU PUMP CHANGE SET UP MENU Parameter Application Range Parameter Application Range Ensures all events in log are correctly date and time stamped month/year Set Time and date (change required for daylight saving). minute/hour Ensures all events in log are correctly date and time stamped month/year Set Time and date (change required daylight saving). minute/hour Limits the forwardfor movement of actuator caused by pressing FF Key Operation 0.1 – 100mm the FF the key forward during syringe loading. Limits movement of actuator caused by pressing FF Key Operation 0.1 – 100mm the FF key during syringe loading. Backlight Duration Limits backlight duration to preserve battery life. 0 – 60 seconds. Backlight Duration Limits backlight duration to preserve battery life. 0 – 60 seconds. Info Duration Sets time info screens are displayed. 1 – 20 seconds. Info Duration Sets time info screens are displayed. 1 – 20 seconds. Turns off the green operation LED to preserve battery life. 0 (Disabled) to Operation LED Red stilloperation operates.LED to preserve battery life. secondsto Turnswarning off the LED green 0 64 (Disabled) Operation LED Red warning LED still operates. 64 seconds Titration Option Enables setting a titration limit (≤ max. rate). Enable/Disable Titration Option Enables setting a titration limit (≤ max. rate). Enable/Disable When entering a new program pump resets to this default 00:00 (OFF) to Default Duration (setting to zero askips during 99:00(OFF) hoursto When entering newduration programstep pump resetsprogramming). to this default 00:00 Default Duration (setting to zero skips duration step during programming). 99:00 hours Occlusion Pressure Sets pressure level at which occlusion alarm will activate. 100-1500mmHg Occlusion Pressure Sets pressure level at which occlusion alarm will activate. 100-1500mmHg 0 (KVO OFF) to KVO Operation Activates Keep Vein Open infusion at End Program. 2.0ml/h 0 (KVO OFF) to KVO Operation Activates Keep Vein Open infusion at End Program. 2.0ml/h Prevents alteration of default duration and infusion rate Program Lock during setalteration up (with Program ON default duration ON/OFF Prevents of defaultLock duration and infusion rate cannot be set to zero). Program Lock during set up (with Program Lock ON default duration ON/OFF cannot be set to zero). Exit Exit Change Set Up menu. Exit Exit Change Set Up menu. Rate Setting Menu Rate Setting Menu Locks the rate mode ml/hr rate each time a new programme Rate Setting 0 - 650ml/h Locks the rate mode ml/hr rate each time a new programme is commenced/syringe is loaded Rate Setting 0 - 650ml/h commenced/syringe is loaded CME Medical T34 OperationisManual Rev 1.4 15 CME Medical T34 Operation Manual Rev 1.4

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2.13 PRE-LOADING, PROGRAMME PROTECTION AND “RESUME” 2.13 PRE-LOADING, PROGRAMME PROTECTION AND “RESUME” NOTE: Sections 13 and 14 describe Pre-Loading, syringe placement and confirmation, these initial NOTE: Sections 13 and 14 describe confirmation, initial sequence are common to all modesPre-Loading, of operationsyringe up untilplacement the correctand syringe has beenthese confirmed. sequence common modes ofvaries operation up untilon thethe correct has been confirmed. From this are point the settoupallsequence depending modesyringe of operation being used and the From this enabled point the up sequence varies depending on the mode operation being used functions orset disabled for the specific clinical application of theof pump. For complete userand the functions enabled or disabled foroperation the specific clinical application the pump. For complete user instructions for specific mode of sequences refer to theofuser guide section. instructions for specific mode of operation sequences refer to the user guide section. PRE-LOADING PRE-LOADING Pre-Loading is a simultaneous sequence of screen information and automatic actuator movement and Pre-Loading is several a simultaneous these performs functions:sequence of screen information and automatic actuator movement and these  performs Self-test several of pumpfunctions: settings  Self-test ofimportant pump settings Displaying pump information  Displaying pump information Automatic important actuator movement deletes any previous programme in the pump memory.  Automatic actuator movement deletes any previous programme in the pump memory. WARNING: The actuator can only be moved as described above. Do not use force to try to move the WARNING: The actuator only be moved asto described above. Doaffect not use force to try to move the actuator manually as thiscan could cause damage the device and/or calibration. actuator manually as this could cause damage to the device and/or affect calibration. When the pump is powered on with the barrel clamp arm down, no syringe in place and during the When the pump is powered on the withfollowing the barrel clampdisplay arm down, no syringe in place and during the automatic actuator movement screens in sequence: automatic actuator movement the following screens display in sequence: A. Pump information A. Pump information Line 1 - Pump model name T34 Line 1 - Pump model name T34 XXXXXX Line 2 - Software version number Version NCAT Line 2 - Software version number Version NCAT XXXXXX ID Syringe Pump Line 3 - Pump identification ID Syringe Pump Line 3 - Pump identification (Default is “syringe pump”, this can be configured to e.g. asset no. (Default is “syringe thisofcan configured to e.g. asset no. or user site, up to a pump”, maximum 17 be digits. or user site, up to a maximum of 17 digits. B. Advisory notice: B. Advisory notice: Pre-Loading It is advisable not to interrupt the automatic actuator movement to Pre-Loading It is advisable not to interrupt the automatic ensure that a previous programme is deletedactuator movement to Use NO to Interrupt ensure that a previous programme is deleted Use NO to Interrupt C. Device settings C. Device Linesettings 1 - Occlusion pressure Line Line 1 2 -- Occlusion Maximum pressure Rate Line Maximum Rate Line 2 3 -- Programme lock status Line lock statusactuator movement this value Line 3 4 -- Programme Battery status (during Line 4 - Battery status actuator movement this value fluctuates, do not rely (during on this as the true battery percentage) fluctuates, do not rely on this as the true battery percentage) D. Load syringe prompt D. LoadThe syringe “Loadprompt Syringe” screen displays and flashes until a syringe is The “LoadinSyringe” detected all threescreen pump displays sensors.and flashes until a syringe is detected in all three pump sensors.

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Occlusion xxx mmHg Occlusion xxx mmHg Max Rate 5ml/h Max RateLock 5ml/h Program ON Program Lock ON Battery Status 99% Battery Status 99%

Load Syringe Load Syringe

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At the end of the pre-loading sequence the actuator returns to the start position of the last infusion. If the user regularly uses the same syringe brand, size and fills to the same volume, powering off and on allows automatic actuator movement which returns the actuator to the correct position each time and should not require adjustment for a new programme/syringe.

T34 PROGRAMME PROTECTION Depending on clinical and infusion requirements the pump can be configured and locked to deliver an infusion by one of three modes of operation, lock on, lock off or rate mode. The programming specifically protects (and resumes) the rate. For example, if an infusion is resumed and the syringe volume has changed the delivery duration will change accordingly: If you increase the syringe volume and resume a programme the duration of delivery will increase. If you decrease the syringe volume and resume a programme the duration of delivery will decrease. RESUME OR NEW SYRINGE? There is only the current “programme” available in the pump memory at any one time. The screen prompt “YES to Resume, NO for New Syringe” displays when any of the following occurs: 

After an alarm activation e.g. syringe displacement WARNING: When this prompt screen displays, before pressing any of the keys be sure you select the right option for the situation. When you press “NO” the current programme is immediately deleted and cannot be retrieved.

 

The pump is powered off (for any reason) and power is restored with a syringe in place. Completion of system purge.

Press YES to Resume

NO for New Syringe Effect on pump programming by key presses:  If the user presses “YES to Resume” – the current programme is resumed (fixed rate).  If the user presses “NO for New Syringe” the current programme is immediately deleted.

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2.14 SYRINGE LOADING, DETECTION AND CONFIRMATION 2.14 SYRINGE LOADING, DETECTION AND CONFIRMATION WARNING: Do not over-label the syringe or apply anything that changes its external diameter at the WARNING: Do not over-label the syringe or apply anything that changes its external diameter at the point where the barrel clamp is applied as incorrect syringe detection may result leading to the pump point where the barrel clamp is applied as incorrect syringe detection may result leading to the pump running at an inappropriate speed for the syringe loaded. running at an inappropriate speed for the syringe loaded. A. On completion of the Pre-Loading sequence and when the “Load Syringe” screen displays, check if A. On completion of the Pre-Loading sequence and when the “Load Syringe” screen displays, check if manual adjustment of the actuator is required by holding the syringe above the device to align the collar manual adjustment of the actuator is required by holding the syringe above the device to align the collar sensor and plunger sensor to the syringe collar and plunger. sensor and plunger sensor to the syringe collar and plunger. BD Plastipak B. Lift the barrel clamp arm fully and turn the arm 90° B. Lift the barrel clamp arm fully and turn the arm 90°

BD Plastipak

C. Place the syringe collar vertically into the pump collar slot, the C. Place the syringe collar vertically into the pump collar slot, the Load Syringe syringe plunger into the pump actuator slot fully, (the syringe Load Syringe syringe plunger into the pump actuator slot fully, (the syringe should click into position) and lower the barrel clamp arm down on should click into position) and lower the barrel clamp arm down on to the barrel of the syringe. As you correctly seat each point of the syringe the flashing indicator for that to the barrel of the syringe. As you correctly seat each point of the syringe the flashing indicator for that sensor becomes solid on the screen display. sensor becomes solid on the screen display. NOTE: If the actuator is not in the required position to accommodate the syringe leave the barrel clamp NOTE: If the actuator is not in the required position to accommodate the syringe leave the barrel clamp arm down and use the FF or BACK keys to move the actuator to the required position. Forward arm down and use the FF or BACK keys to move the actuator to the required position. Forward movement of the actuator is limited, therefore repeated presses of the FF key may be required when movement of the actuator is limited, therefore repeated presses of the FF key may be required when moving the actuator forward. Backwards movement is not restricted. moving the actuator forward. Backwards movement is not restricted. D. When all three sensors have detected the syringe the screen displays the D. When all three sensors have detected the syringe the screen displays the size and brand of the syringe detected: size and brand of the syringe detected:

20ml 20ml BD BD Plastipak Plastipak Select ↑↓, Press YES Select ↑↓, Press YES

E. Check that the syringe brand and size inserted into the pump matches the syringe detected, if they E. Check that the brand match confirm bysyringe pressing YES. and size inserted into the pump matches the syringe detected, if they match confirm by pressing YES. NOTE: If the syringe brand displayed is not correct, use the ↑ or ↓ arrow keys to scroll between NOTE: If the syringe brand displayed is not correct, use the ↑ or ↓ arrow keys to scroll between brands of similar dimensions, then press YES to confirm. This will only happen if the syringe selected brands of similar dimensions, then press YES to confirm. This will only happen if the syringe selected has dimensions within +/- 1% of another commonly used brand. has dimensions within +/- 1% of another commonly used brand. The subsequent screens that display following syringe confirmation are dependant on pump set up and The subsequent screens that display following syringe confirmation are dependant on pump set up and pump configuration, refer over the page for examples of common modes of operation. pump configuration, refer over the page for examples of common modes of operation. NOTE: If the pump fails to recognise any syringe, it may be positioned incorrectly/fully. To rectify, try NOTE: If the pump fails to recognise any syringe, it may be positioned incorrectly/fully. To rectify, try reseating the syringe. If the problem persists, the syringe brand/size being fitted may not be configured reseating the syringe. If the problem persists, the syringe brand/size being fitted may not be configured to the pump. Either use a compatible syringe make/brand or arrange for the new type of syringe to be to the pump. Either use a compatible syringe make/brand or arrange for the new type of syringe to be configured into the pump by authorised personnel. configured into the pump by authorised personnel. WARNING: Never take a syringe that is not empty off the pump if it is still connected to the patient. WARNING: Never take a syringe that is not empty off the pump if it is still connected to the patient. The infusion line must be disconnected or clamped before removing the syringe to prevent free flow The infusion line must be disconnected or clamped before removing the syringe to prevent free flow and the risk of serious injury or death to the patient. and the risk of serious injury or death to the patient. WARNING: If the Volume to be Infused displayed on the pump LCD after confirming the syringe varies by WARNING: If the Volume to be Infused displayed on the pump LCD after confirming the syringe varies by more than 5% of the actual syringe volume visually confirmed on the syringe scale, remove the syringe, more than 5% of the actual syringe volume visually confirmed on the syringe scale, remove the syringe, turn off the pump and, with the barrel clamp arm down, turn the pump on to allow pre-loading to occur. turn off the pump and, with the barrel clamp arm down, turn the pump on to allow pre-loading to occur. Repeat the Syringe placement and detection steps and ensure the correct syringe size and brand are Repeat the Syringe placement and detection steps and ensure the correct syringe size and brand are confirmed. If the calculated volume reading is still significantly different from the visually confirmed confirmed. If the calculated volume reading is still significantly different from the visually confirmed contents, remove the pump from use and return to an authorized service centre for inspection, testing contents, remove the pump from use and return to an authorized service centre for inspection, testing and calibration. Using a syringe not approved by the pump manufacturer could affect device and calibration. Using a syringe not approved by the pump manufacturer could affect device performance, resulting in over-delivery or under-delivery of medication to the patient. performance, resulting in over-delivery or under-delivery of medication to the patient.

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2.15 LOCK ON, LOCK OFF AND RATE MODES OF OPERATION

Up until the point of syringe confirmation, the sequences and screen prompts are common to all modes of operation, subsequent steps, until the infusion is started, will take different paths depending on whether the pump has been configured to Lock ON , Lock OFF or Rate mode of operation and pump configuration. The table below provides examples of screen sequences and information for common pump configurations. Lock OFF (rate) Titration disabled

LOCK OFF (duration) Titration disabled

LOCK ON

The sequences below, display following confirmation of syringe brand and size

20ml BD Plastipak

Select ↑↓, Press YES

Volume 12.0ml Occlusion x mmHg Programme Duration 24:00 Max Rate xml/h Default settings summary Rate 0.50ml/h Program Lock OFF Confirm, Press YES Battery Status xx%

Occlusion x mmHg Max Rate xml/h Default settings Program Lock OFF Battery Status xx%

Start infusion when ready to do so

Confirm or 20ml BD Plastipak Volume 12 ml change volume Change ↑↓ Press YES

Confirm or 20ml BD Plastipak 12 ml change volume Volume Change ↑↓ Press YES

Confirm or 20ml BD Plastipak change default Duration 24:00 duration Change ↑↓ Press YES

Enter ml/hour 20ml BD Plastipak 0ml/h rate required Rate Change ↑↓ Press YES

Confirm 20ml BD Plastipak 0.5 ml/h ml/hr rate Rate Confirm, Press YES

Volume 12.0ml Programme Duration 24:00 summary Rate 0.50ml/h

Volume 12.0ml Programme Duration 24:00 summary Rate 0.50ml/h

Start infusion when ready to do so

START INFUSION?

Confirm, Press YES

Start infusion when ready to do so

Confirm, Press YES

START INFUSION?

If titration is enabled additional screen prompts will display

START INFUSION?

If the default duration is changed and/or titration is enabled additional screen prompts will display

2.16 RATE CHANGE (TITRATION) DURING INFUSION

Rate titration can be enabled so that the rate can be changed during infusion within pre-set titration maximum (max.) limits and titration minimum (min.) limits.   

The rate cannot be titrated in Lock ON mode. The rate can be titrated in Lock OFF only when rate titration is enabled. The rate can be titrated in Rate Mode only when rate titration is enabled. NOTE: The rate cannot be titrated with the keypad locked.

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2.17 RECOMMENDED SAFETY CHECKS DURING INFUSION

It is recommended that procedures are established for regular checks on the progress of the infusion. A. To confirm the infusion is running: 1. Ensure the infusion running screen displays: Line 1 - displays infusion time remaining Line 2 - displays the ml/hr infusion rate Line 3 - alternates between syringe size and brand confirmed by the user during set up (as shown) and “<<<< Pump Delivering” 2. Check the LED light is intermittently flashing green B. To check volume infused (VI) and volume to be infused (VTBI), press the INFO key once:

Time Remaining 23:42

Rate 0.71 ml/hr 20ml BD Plastipak

Infusion Summary VTBI 11.00

VI 0.8

Battery Level C. To check battery life, press the INFO key twice:

80% Empty

Full

NOTE: After pressing the INFO key either a third press or waiting a few seconds returns the display to the base display screen. Excessive key presses or usage of the INFO feature will reduce battery life. Use only as required to optimize battery performance.

2.18 ALERTS, ALARMS AND TROUBLESHOOTING ALERT CONDITIONS The pump will activate an alert for:  Program Nearly Complete  Low Battery

ALERT ACTIVATION When the alert activates :  The infusion continues  Three beeps are heard approximately every three/four minutes  A screen message alternates with the infusion running screen until the end of the battery/infusion The alert activates approximately 15-30 minutes prior to an alarm state. ALARM CONDITION The pump will activate an alarm for:  End of Infusion  Pump paused too long  End Battery  Syringe displaced  Occlusion/Empty Syringe  Occlusion/Check line  System Error CME T34 Operation Manual Manual Rev 1.4 Rev 1.4 20 Medical CME Medical T34 Operations

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