t34 operation manual - sussex community · 2.19 kvo (keep vein open) ... remove the t34 syringe...

CME McKinley T34 Operation Manual Rev 1.2

T34 Operation Manual

CME UK T34 Operation Manual Rev 1.2

CME McKinley T34 Operation Manual Rev 1.2 2

Section 1 INTRODUCTION 3-8

1.1 Pump Overview ............................................................................................................. 3 1.2 Modes Of Operation ...................................................................................................... 3 1.3 Intended Use ................................................................................................................. 3 1.4 Contraindications ........................................................................................................... 3 1.5 About This Manual ......................................................................................................... 4 1.6 Warnings And Notes ...................................................................................................... 4 1.7 Operating Precautions ................................................................................................... 4-5 1.8 System Symbols ............................................................................................................. 6 1.9 Pump Inspection And Unpacking ................................................................................... 7 1.10 Lockbox .......................................................................................................................... 7 1.11 Carry Pouches ................................................................................................................ 7 1.12 BodyComm Communications Software ......................................................................... 8 1.13 Disposable and Rechargeable Batteries ........................................................................ 8

Section 2 FEATURES AND FUNCTIONS 9-21

2.1 Pump Feature Recognition ............................................................................................... 9 2.2 Access Codes .................................................................................................................... 10 2.3 Keypad Lock ..................................................................................................................... 10 2.4 Event Log .......................................................................................................................... 11 2.5 Post Occlusion Bolus ........................................................................................................ 11 2.6 Syringe Brands And Sizes ................................................................................................. 12 2.7 Administration Sets .......................................................................................................... 12-13 2.8 Battery Fitting .................................................................................................................. 14 2.9 Battery Life ....................................................................................................................... 14 2.10 Powering On, Pump Paused/Stopped and Powering Off ................................................. 14 2.11 Pump Info Menu .............................................................................................................. 15 2.12 Pump And BodyComm Configuration .............................................................................. 15 2.13 Pre-Loading, Programme Protection And “Resume/New Syringe ................................... 16-17 2.14 Syringe Loading, Detection And Confirmation ................................................................. 18 2.15 Lock ON, Lock OFF And Rate Modes Of Operation .......................................................... 19 2.16 Rate Change (Titration) during Infusion ........................................................................... 19 2.17 Recommended Safety Checks During Infusion ................................................................ 20 2.18 Alerts, Alarms And Troubleshooting ................................................................................ 20-21 2.19 KVO (keep vein open) ....................................................................................................... 22 2.20 Purge function .................................................................................................................. 22

Section 3 MAINTENANCE, CLEANING AND SERVICE 23-24

3.1 Pump Cleaning ................................................................................................................. 23 3.2 Lockbox Cleaning .............................................................................................................. 23 3.3 Re-Usable Pouch Cleaning ............................................................................................... 23 3.4 Pump Storage ................................................................................................................... 23 3.5 Servicing ........................................................................................................................... 24 3.6 Disposal/Decommissioning .............................................................................................. 24

Section 4 USER GUIDES 24-34

4.1-4.10 User Guides ....................................................................................................................... 25-34

Section 5 APPENDICES 35-36

5.1 T34 Syringe Pump Specifications ..................................................................................... 35 5.2 Limited Warranty ............................................................................................................. 36 5.3 Contact Details ................................................................................................................. 37 5.4 Index ................................................................................................................................ 38


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 in-cluding intravenous and subcutaneous. The T34 offers 3 point syringe detection enabling the pump to identify all commonly used (or pro-grammed) syringe brands. This feature also enables the pump to calculate the syringe volume and, de-pending on the mode of operation, deliver the contents over a specified duration or as mls per hour infu-sion 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 opera-tion 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 deliver-able 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 in-cluding intravenous, subcutaneous, percutaneous, epidural in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who re-quire maintenance medications, analgesics, chemotherapeutic agents and general fluids therapy in hospi-tal and homecare environments.

1.4 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 capabil-ity to self-administer their therapy; or who are not under the care of a responsible individual.

1.5 ABOUT THIS MANUAL 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 op-erating 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 rele-vant Harmonised Standards. Data presented in the technical specifications reflect specific test condi-tions 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 re-sult 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 warn-ings 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 condi-tions: (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 McKinley 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 ser-viced in accordance with the instructions given in this manual. If the pump has failed to calibrate dur-ing 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. Unauthor-ised modifications or the use of any spare parts, other than those supplied by the manufacturer or their distributor, will void any warranty.


If the pump is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified personnel. The pump has been designed to be as safe as possible to handle; however, care should be exercised to avoid trapping of fingers or other body parts in the mechanism. The T34 syringe pump system should be operated within a temperature range of 15°C (59°F) to 45°C (113°F). Operation at temperatures outside this range may affect accuracy.

INFUSION PRECAUTIONS

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 practition-er. Caution must be exercised in the selection of drugs and the amount and rate intended to be deliv-ered 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 expo-sure. As with all automatic infusion devices, whenever a toxic or dangerous level of drug is stored in the res-ervoir, 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 dis-played.


1.8 SYSTEM SYMBOLS The following symbols are used on the T34 syringe pump and components. Labels on the pump or state-ments 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.

SYMBOL DESCRIPTION

IPX3 Degree of protection against ingress of water

Type of protection against electric shock—Class 11 equipment

Attention, consult accompanying instructions

CSA mark

0344 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.

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

Type CF applied part

Date of Manufacture

SN Serial Number

Expiry Date (consumables)

LOT Lot Number (consumables)

STERILE EO


1.9 PUMP INSPECTION AND UNPACKING Remove the T34 syringe pump and accessories from the packaging and inspect for damage during ship-ment or storage.

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.

1.10 LOCKBOX The lockbox will fit syringe 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 en-sures 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 metre.

Refer to your local sales representative or CME McKinley 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 McKinley website for information on types, codes and costs.

WARNING: Do not use the T34 syringe pump if there are any obvious signs of damage. Return for in-spection by authorised service personnel.

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.

NOTE: lockboxes are designed for the use with CME McKinley administration sets. If using an alternate brand of administration set with a 30ml syringe the set design may prevent the lockbox from fully closing and locking.

WARNING: Unsafe operation may result from usingimproper accessories. Only use accessories designed for the system.


1.12 BODYCOMM COMMUNICATIONS SOFTWARE BodyComm is a PC based software package which enables the engineer to programme your pumps via RS232 communication charger/docking station. The software allows you

to save the setup and syringe data and replay these files on to subsequent pumps. BodyComm also enables the user to down-load, save and print the events log. Use of this programme can aid the investigation of clinical incidents and help ensure that all pumps are configured the same way without error.

1.13 BATTERIES DISPOSABLE BATTERIES Always use a 9 volt alkaline battery. These batteries can easily be identified by the international marking code 6LR61 (a recommended battery of this type is the Duracell Plus MN1604). Zinc-carbon batteries (marked 6F22 or 6R61 (for example a PP3) are not recommended for use with the T34. These batteries perform poorly and need to be replaced more often. Do not use non-alkaline batter-ies. There is some variation in size between different brands of batteries. Never try to force a battery into the battery compartment as this may damage the battery contacts. Incorrectly aligning the battery contacts will not cause any harm to the battery or the pump. Remove the battery and re-align the contacts. RECHARGABLE BATTERIES PowerBank 9V Ni-Cad/Ni-MH Plug-In Battery Charger FEATURES

Charges 1-2pcs Ni-Cad or Ni-MH 9V batteries Supplied with 2x9V 170mAh Ni-MH rechargeable batteries Dual LED charging indicators Innovative design High drain performance Up to 1,000 cycles

TECHNICAL DATA

Input Power 2.5W

Input Voltage 220V ac 50Hz

Output Voltage 2x9.8V dc

Charge Time 8hrs (150mAh), 10hrs (170mAh)

Charging Current 24mA ±12%

Dimensions (WxHxD) 66 x 97 x 66mm

NOTE: Using rechargeable batteries may slightly affect the accuracy of the battery level percentage dis-played on the pump screen and may influence the syringe travel calibration due to voltage differences between disposable and rechargeable batteries.


SECTION 2 FEATURES AND FUNCTIONS 2.1 PUMP FEATURE RECOGNITION

5 6 7 8 9 10 11 12 13

FEATURE DESCRIPTION

5. INFO key (a) whilst infusing shows infusion summary, protocol parameters and battery level (b) when pump paused, access the main menu (c) activates/deactivates keypad lock

6. UP arrow key (a) scrolls between options (b) increases infusion parameters during programming/titration

7. DOWN arrow key (a) scrolls between options (b) decreases infusion parameters during programming/titration

8. YES/START key Confirms selection and starts infusion

9. NO/STOP key (a) stops infusion (b) takes user back a step during programming

10. FF (Forward) key (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

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


14.0 INFO MENU Information and pump configurable settings are available via the Info menu. Pressing the INFO key when no infusion running displays: (To identify the option referred to, an arrow appears and the font size is larger than the other options in the menu) Use scroll keys ↓/↑ to move down/up through the menu, press YES to View selection. Battery Level – displays the battery level as a percentage. The battery level can also be viewed via INFO button during infusion checks. Rate Setting – access code protected area. The pump can be configured to allow........ Event Log - date and time stamped record of key presses and pump status (see below). Change Set Up – a access code protected area. Several pump settings can be set via “change set up”, and should only be accessed by staff who are trained and authorised to do so. Exit - to exit the Info menu

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.

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 McKinley) 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 McKinley) and authorised electrical biomedical engineering personnel.

2.3 KEYPAD LOCK The keypad has a locking feature that prevents unintentional powering off of the unit. As well as the abil-ity 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. 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.

NOTE: Codes will only be provided by CME McKinley 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 man-ual.

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 McKinley Technical services department for access codes and information on pump configuration and training.

Lock Mode

OFF ON


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 de-letes the oldest event in the log each time a new event occurs. To view the event log: A. With no infusion running, press NO to access the Info menu: B, Scroll down using the ↓ arrow to “Event Log”, press YES C. The most recent event displays: 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

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

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 in-crease 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.

Info Menu

Battery Level Select ↓↑, Press YES

Info Menu

Event Log Select ↓↑, Press YES

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

Event No: 2635 08.10.2009 16:12 Stop Infusion

Press INFO - Details

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

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.


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 com-munication 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 McKinley Technical Services.

2.7 ADMINISTRATION SETS The T34 pump can be operated with any extension set with a luer connection. However, it is recom-mended, to optimise system accuracy and performance, that proprietary sets from CME McKinley are used. All sets have siphon/free flow protection.

WARNING: DO NOT use slip-tip syringes. Luer lock syringes must always be used to ensure secure con-nection 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 in-fection may result from the use of non-sterile components. Maintain sterility of all disposable compo-nenets and do not re-use singe use sets.


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

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.

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

WARNING: Disposables must be compatible with the medicine delivered. Please check with the manu-facturer of the administration set before use.

WARNING: A kinked/occluded infusion line may impair the operation oand accuracy of the pump. Be-fore 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 compo-nent damage.

WARNING: Replace the set in accordance with local guidelines.


2.9 BATTERY LIFE Depending on the infusion rate, number of key presses and pump interactions the battery life is approxi-mately 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.

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). 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 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 pow-er is removed.

C. Remove battery if the pump is no longer required. D. Remove syringe and place the barrel clamp arm down.

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

Pump Paused Press YES to Start

Battery Level

80%

Empty Full

Off

Wait For Beep

T34 Version XXXXXX ID: Syringe Pump

WARNING: Before removing a syringe from a pump ensure the line is disconnected from the patient to prevent unintended drug delivery to the patient.


Info Menu

=> Battery Level Select ↑↓, Press YES

2.11 PUMP INFO MENU

TO ACCESS THE INFO MENU: A. With no infusion running, press NO to display: B. Use the ↓/↑ arrow keys to scroll to the option required and press YES to view the option required.

2.12 PUMP AND BODYCOMM CONFIGURATION A limited number of settings can be configured via the pump in ”Change Set Up”, “Rate Setting” and “Technician” menu. Full pump configuration can only be carried out via the BodyComm communications docking station and PC software. Pump configuration can be carried out via the Change Set Up and Rate Setting menus

INFO MENU OPTIONS

OPTION DESCRIPTION

Battery Level View battery life percentage (graph)

Event Log View pump event log

Rate Setting (access code protected) Locks the rate mode ml/hr rate

Change set up (access code protected) Change and configure programming functions

Exit Exits Info menu

PUMP CHANGE SET UP MENU

Parameter Application Range

Set Time and date Ensures all events in log are correctly date and time stamped (change required for daylight saving). month/year

minute/hour

FF Key Operation Limits the forward movement of actuator caused by pressing the FF key during syringe loading. 0.1 – 100mm

Backlight Duration Limits backlight duration to preserve battery life. 0 – 60 seconds.

Info Duration Sets time info screens are displayed. 1 – 20 seconds.

Operation LED Turns off the green operation LED to preserve battery life. Red warning LED still operates. 0 (Disabled) to

64 seconds

Titration Option Enables setting a titration limit (≤ max. rate). Enable/Disable

Default Duration When entering a new program pump resets to this default (setting to zero skips duration step during programming). 00:00 (OFF) to

99:00 hours

Occlusion Pressure Sets pressure level at which occlusion alarm will activate. 100-1500mmHg

KVO Operation Activates Keep Vein Open infusion at End Program. 0 (KVO OFF) to 2.0ml/h

Program Lock Prevents alteration of default duration and infusion rate during set up (with Program Lock ON default duration cannot be set to zero).

ON/OFF

Exit Exit Change Set Up menu.

Rate Setting Menu

Rate Setting Locks the rate mode ml/hr rate each time a new programme is commenced/syringe is loaded

0 - 650ml/h


2.13 PRE-LOADING, PROGRAMME PROTECTION AND “RESUME”

PRE-LOADING Pre-Loading is a simultaneous sequence of screen information and automatic actuator movement and these performs several functions:

Self-test of pump settings Displaying important pump information Automatic actuator movement deletes any previous programme in the pump memory.

When the pump is powered on with the barrel clamp arm down, no syringe in place and during the auto-matic actuator movement the following screens display in sequence: A. Pump information

Line 1 - Pump model name

Line 2 - Software version number

Line 3 - Pump identification

(Default is “syringe pump”, this can be configured to e.g. asset no. or user site, up to a maximum of 17 digits.

B. Advisory notice: It is advisable not to interrupt the automatic actuator movement to ensure that a previous programme is deleted C. Device settings

Line 1 - Occlusion pressure Line 2 - Maximum Rate Line 3 - Programme lock status Line 4 - Battery status (during actuator movement this value fluctuates, do not rely on this as the true battery percentage)

D. Load syringe prompt

The “Load Syringe” screen displays and flashes until a syringe is detected in all three pump sensors.

WARNING: The actuator can only be moved as described above. Do not use force to try to move the actuator manually as this could cause damage to the device and/or affect calibration.

T34 Version NCAT XXXXXX

ID Syringe Pump

Pre-Loading

Use NO to Interrupt

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

Load Syringe

WARNING: If any foreign object is trapped behind the actuator during the Pre-Loading sequence, the user must immediately press the STOP key and then press the FF key in order to release the trapped object. If the End Battery alarm is activated, press YES to confirm the alarm then press FF to release the trapped object.

NOTE: Sections 13 and 14 describe Pre-Loading, syringe placement and confirmation, these initial se-quence are common to all modes of operation up until the correct syringe has been confirmed. From this point the set up sequence varies depending on the mode of operation being used and the functions enabled or disabled for the specific clinical application of the pump. For complete user in-structions for specific mode of operation sequences refer to the user guide section.


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

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.

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.

Press YES to Resume NO for New Syringe


2.14 SYRINGE LOADING, DETECTION AND CONFIRMATION

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 sensor and plunger sensor to the syringe collar and plunger. B. Lift the barrel clamp arm fully and turn the arm 90° C. Place the syringe collar vertically into the pump collar slot, the syringe plunger into the pump actuator slot fully, (the syringe 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 sensor becomes solid on the screen display.

D. When all three sensors have detected the syringe the screen displays the size and brand of the syringe detected: E. Check that the syringe brand and size inserted into the pump matches the syringe detected, if they match confirm by pressing YES.

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.

20ml BD Plastipak

Select ↑↓, Press YES

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 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.

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 has dimensions within +/- 1% of another commonly used brand.

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 move-ment 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.

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 running at an inappropriate speed for the syringe loaded.

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 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 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. 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 con-tents, 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 performance, resulting in over-delivery or under-delivery of medication to the patient.

Load Syringe

BD Plastipak


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 configura-tions.

LOCK ON LOCK OFF (duration)

Titration disabled

Lock OFF (rate) Titration disabled

The sequences below, display following confirmation of syringe brand and size 20ml BD Plastipak Select ↑↓, Press YES

Programme summary

Volume 12.0ml Duration 24:00 Rate 0.50ml/h Confirm, Press YES

Default settings

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

Default settings

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

Start infusion when ready

to do so START INFUSION? Confirm or change volume

20ml BD Plastipak Volume 12 ml Change ↑↓ Press YES

Confirm or change volume

20ml BD Plastipak Volume 12 ml Change ↑↓ Press YES

Confirm or

change default duration

20ml BD Plastipak Duration 24:00 Change ↑↓ Press YES

Enter ml/hour rate required

20ml BD Plastipak Rate 0ml/h Change ↑↓ Press YES

Confirm ml/hr rate

20ml BD Plastipak Rate 0.5 ml/h

Confirm, Press YES

Programme summary

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

Confirm, Press YES

Programme summary


Confirm, Press YES


to do so START INFUSION?

If titration is enabled additional screen prompts will display


to do so 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.


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 “


ALARM ACTIVATION

When the alarm activates:

The infusion stops.

The LED indicator light turns from green to red.

The alarm sound continuously until either the pump is paused or the problem is rectified.

An error message appears on the display indicating the alarm cause.

TROUBLESHOOTING SCREEN INFORMATION RESULT/CAUSE POSSIBLE ACTIONS

Pump Paused Too Long

Prompt: The pump has been paused on stand-by for more than 2 minutes

Either press YES to restart infusion, press NO to continue pause or turn the power off

Keypad Locked

Prompt: Only the STOP, START and INFO keys are accessible.

Disengage keypad lock if further access required

Press YES to Resume, NO for New Syringe

Prompt: The current programme has been interrupted and two options are available for programming

Pressing YES resumes the current infusion. Pressing NO deletes the current programme

Low Battery Alert: Battery is almost depleted Prepare to charge pump

End Battery Alarm: Battery will fail imminently Charge pump

Program nearly complete Alert: Syringe is almost empty.

Prepare to change syringe or turn pump off

Syringe Empty Remove Syringe

Alarm: Current infusion programme has completed

Power the pump off or change the syringe to start a new infusion

Syringe Displaced, Check Syringe

Alarm: One or more of the syringe detection sensors is not detecting

Check the syringe and re-seat as necessary. Check screen messages for assistance

Occlusion/ Empty Syringe/Check Line

Alarm: Clamp on line, tubing occluded or kinked. Pump has reached the minimum travel position

Release the clamp, flush/replace the access device or clear the occlusion

System Error. Press and hold INFO

Alarm: An internal system error has occurred

The user may be prompted to pow-er off and restart, which may recti-fy the error. If error recurs: Take pump out of use. Press INFO to obtain error message. Record error code and summary of fault and return pump to designated service centre.

Error No xxx

NOTE: The screen information shown is representative only.


2.19 KVO (Keep Vein Open) OPERATION The T34 can be configured to deliver a KVO infusion to commence at END PROGRAM to keep the pa-tients access device patent. With KVO enabled T34 applies the KVO rate set until the syringe is empty. After three/four beeps the End Program alarm stops and the pump switches to the configured KVO infusion rate. Every three/four minutes three/ four beeps will be heard to confirm the pump is still running/infusing. When the syringe is empty the end program alarm activates and the screen reads “End Program, Press YES to confirm”. When the screen displays confirmation of syringe brand and size, press NO and power the pump off.

2.20 PURGE OPTION In order to eliminate/reduce mechanical slack (visible spaces at the syringe collar and plunger loading points) and ensure a faster start up time (time to start delivering the fluid to the patient/reach the pro-grammed infusion rate) the user can purge the system. This facility is available (if enabled) once only, prior to commencing an infusion. When the system is purged, the volume will reflect in the total deliv-erable volume. The purge volume default is 0.2ml and the maximum deliverable is 2.0 ml. To disable purge function set default to 0.0ml. The purge function is configured via the Technician menu or the BodyComm communi-cations software.

Purge System Slack?

Purge completed

Press NO when done

Hold FF key to purge

Purge 0.00ml

WARNING! Disconnect patient from

the pump PRESS YES TO CONFIRM

0.5ml/h


Confirm, Press YES

TO PURGE SYSTEM SLACK (any mode of operation) During infusion set up, when the infusion summary displays: A. Press the FF key B. Press YES to commence purge function C. ENSURE LINE IS DISCONNECTED FROM THE PATIENT BEFORE PURGING, press YES to confirm D. Press and hold the FF key to purge the volume required or until the slack is removed and/or purge is completed. If the full pre-set amount is purged the next screen will display automatically.

E. Press NO to confirm completion, alternately wait a few seconds and the next screen displays automatically then follow screen prompts.


SECTION 3 MAINTENANCE, CLEANING AND SERVICE T34 syringe pump requires annual maintenance and calibration. In between maintenance the pump Requires cleaning only between patients (or as necessary). It is recommended that the performance of the pump is checked periodically.

3.1 PUMP CLEANING Before connecting the pump to a patient, and periodically during use, clean the unit using a lint-free cloth lightly dampened with warm water and a mild detergent, disinfectant or a bleach solution up to concentra-tion of 10%. Once a month (or as required) clean the main pump screw thread and guiding rods with a small dry brush to remove debris or other particles.

3.2 LOCKBOX CLEANING CME McKinley recommends the use of alcohol sprays and wipes to decontaminate the lockbox. Other products may be used but users should be aware that extended usage could result in the lock box becom-ing brittle and susceptible to damage. The substances listed below may adversely impact products constructed from polycarbonate:

3.3 RE-USABLE POUCH CLEANING Clean fabric made products according to need with wet wipes containing water or alcohol. When thorough cleaning is required, use machine laundry at 30°c.

Do not spin wash.

Do not bleach.

Do not heat dry.

Do not iron.

3.4 PUMP STORAGE If the pump is to be stored for an extended period it should be cleaned and the battery removed. Store in a clean, dry atmosphere at room temperature and, if available, use the original packaging or a suitable alter-native, for protection.

Alkali bleaches such as sodium hypochlorite Butyl acetate Methanol Acetone Sodium hydroxide Methyl ethyl ketone Acrylonitrile Chloroform Styrene Ammonia Dimethylformamide Tetrachloroethylene Amyl acetate Concentrated hydrochloric acid Toluene Benzene Concentrated hydrofluoric acid Concentrated sulfuric acid Bromine Iodine Xylene

WARNING: Do not clean the syringe pump with chemicals such as Xylene, Acetone or similar solvents. These chemicals can cause damage to components and labels.

WARNING: Always turn the syringe pump off before cleaning.

WARNING: Do not soak or immerse any part of the T34 in water or any other solution, immersing the pump in liquid could cause damage to components.

http://en.wikipedia.org/wiki/Sodium_hypochloritehttp://en.wikipedia.org/wiki/Butyl_acetatehttp://en.wikipedia.org/wiki/Methanolhttp://en.wikipedia.org/wiki/Acetonehttp://en.wikipedia.org/wiki/Sodium_hydroxidehttp://en.wikipedia.org/wiki/Methyl_ethyl_ketonehttp://en.wikipedia.org/wiki/Acrylonitrilehttp://en.wikipedia.org/wiki/Chloroformhttp://en.wikipedia.org/wiki/Styrenehttp://en.wikipedia.org/wiki/Ammoniahttp://en.wikipedia.org/wiki/Dimethylformamidehttp://en.wikipedia.org/wiki/Tetrachloroethylenehttp://en.wikipedia.org/wiki/Amyl_acetatehttp://en.wikipedia.org/wiki/Hydrochloric_acidhttp://en.wikipedia.org/wiki/Toluenehttp://en.wikipedia.org/wiki/Benzenehttp://en.wikipedia.org/wiki/Hydrofluoric_acidhttp://en.wikipedia.org/wiki/Sulfuric_acidhttp://en.wikipedia.org/wiki/Brominehttp://en.wikipedia.org/wiki/Iodinehttp://en.wikipedia.org/wiki/Xylene


3.5 SERVICING The Pump must only be serviced or repaired by either CME McKinley service centre, its approved service representative or a qualified biomedical technician trained and certified by CME McKinley. Refer to pages 4-5 for operating precautions.

3.6 DISPOSAL/DECOMISSIONING When the time comes to dispose of the pump, accessories or packaging do so in the best way to minimise any negative impact on the environment. You may be able to use special recycling or disposal schemes. To find out about these contact your local waste disposal service. Existing national or local regulations concerning waste disposal must take precedence over the above advice.

SECTION 4 USER GUIDES All guides contained in this manual demonstrate commonly-used sequences and features and are provid-ed for the purpose of illustration and general guidance only. You must refer to local policy for specific use of the T34 syringe pump and the use of accessories for your clinical area and organisation. If the pump has been configured to local requirements screen sequences and screen information may vary from these shown in this manual.

USER GUIDE CONTENT 4.1 LOCK ON Prime and Load .................................................................................................................. 25 4.2 LOCK ON Prime and Load (with purge enabled)................................................................................. 26 4.3 LOCK ON Load and Prime .................................................................................................................. 27 4.4 LOCK OFF Prime and Load ................................................................................................................. 28 4.5 LOCK OFF Load and Prime ................................................................................................................. 29 4.6 LOCK OFF with maximum and minimum titration limits and rate change during infusion ............... 30 4.7 RATE Mode ........................................................................................................................................ 31 4.8 RATE Mode with maximum and minimum titration limits and rate change during infusion ............ 32 4.9 Change Pump Configuration via Change Set Up Menu....................................................................... 33 4.10 Change Program Lock ON (Fixed Duration) to Lock OFF (Change Duration)...................................... 34


4.1 LOCK ON Prime and Load 1. PREPARE THE SYRINGE AND INFUSION LINE a. Prepare syringe with drug (s) as per prescription and local policy, attach drug label.

When applying the drug label, ensure the label lies flat on the syringe. 2. MANUALLY PRIME THE LINE a. Attach prepared syringe to the infusion set and manually prime the line 3. CHECK THE PUMP a. Ensure that the device is clean, visually intact and appropriate for the intended use 4. INSERT THE BATTERY a. b. c.

Slide the compartment cover off the back of the pump. Push the battery into the compartment taking care to ensure that the battery and pump + / - contacts icons align. Slide the cover back on.

5. POWER ON AND PRE-LOADING

a. b.

BEFORE POWERING ON ENSURE THE BARREL CLAMP ARM IS DOWN AND NO SYRINGE IN PLACE Press and hold down the ON/OFF key - the LCD display will show “Pre-Loading” and the actuator will start to move. Wait until it stops moving and the syringe sensor detection screen (Load Syringe) appears.

The automatic actuator movement will delete any previous programme in the pump memory. At the end of Pre-Loading the actuator returns to the start position of the last infusion programmed. The screen prompt “Load Syringe” will continue to flash until the syringe is correctly seated.

6. CHECK BATTERY LEVEL (%) a. b.

Press the INFO key to display “Battery Level”, press YES to view battery meter. Wait a few seconds for the “Load Syringe” screen to display.

7. SYRINGE LOADING, DETECTION AND CONFIRMATION a. b. c. d. e.

Check if manual adjustment of the actuator is required by holding the syringe above the device to align the collar sensor to the syringe collar and plunger sensor to the syringe plunger. Use the FF/Back keys to move the actuator forward/back as necessary so the syringe will fit. Lift the barrel clamp arm as far as it will go and turn it (left or right) 90°. Place the prepared syringe and set into the pump collar and plunger slots fully and return the barrel clamp arm to the down position to secure it on the top of the syringe. View the display screen to check that the syringe brand and size displayed matches the one placed into the pump. If they match confirm by pressing ‘YES’.

The syringe brand and size displayed must match the one being used, if not, use the up/down arrow keys to scroll to the syringe brand to match then press YES to confirm. If no syringe brand and size displays, re-adjust the syringe in the sensors.

8. REVIEW AND CONFIRM INFUSION PROGRAMME a. b.

Review the infusion summery to check that the parameters displayed match the prescription. - Visibly check if the volume in the syringe matches the volume displayed. - Check duration displayed is the duration required for the infusion. - Check that the rate displayed is the syringe volume confirmed divided by the duration.

To confirm infusion parameters, press YES 9. CONNECT LINE TO PATIENT a. Site/connect the infusion line to the patient. (Follow local policy for the recommended cannula and line to use). 10. START INFUSION a. Press YES to commence the infusion when ready to do so. 11. CHECK AND CONFIRM THE INFUSION IS RUNNING a. Visually check that: The infusion running screen is visible and the green light flashes intermittently.

Place pump in lockbox and activate keypad lock if required, according to local policy.


4.2 LOCK ON Prime and Load (with purge enabled)

1. PREPARE THE SYRINGE AND INFUSION LINE a. Prepare syringe with drug (s) as per prescription and local policy, attach drug label.

When applying the drug label, ensure the label lies flat on the syringe. 2. MANUALLY PRIME THE LINE

a. Attach prepared syringe to the infusion set and manually prime the line 3. CHECK THE PUMP

a. Ensure that the device is clean, visually intact and appropriate for the intended use 4. INSERT THE BATTERY

a. b. c.



a. b.

BEFORE POWERING ON ENSURE THE BARREL CLAMP ARM IS DOWN AND NO SYRINGE IN PLACE Press and hold down the ON/OFF key—the LCD display will show “Pre-Loading” and the actuator will start to move. Wait until it stops moving and the syringe sensor detection screen (Load Syringe) appears.

The automatic actuator movement will delete any previous programme in the pump memory. At the end of Pre-Loading the actuator returns to the start position of the last infusion programmed. The screen prompt “Load Syringe” will continue to flash until the syringe is correctly seated.



7. SYRINGE LOADING, DETECTION AND CONFIRMATION a.

b. c. d.

e.



8. ACTIVATE PURGE FUNCTION a. b. c.

d.

Press the FF key. Press YES to confirm purge function is required. Press and down the FF key until the slack is removed or delivery of default purge volume is complete and wait until the next screen displays. Press the option required according to local policy:

Press “YES to Resume” (the delivery duration decreases). Press “NO for New Syringe” (the delivery will remain at the default duration (e.g. 24 hours).

9. REVIEW AND CONFIRM INFUSION PROGRAMME a.

b.


To confirm infusion parameters, press YES 10. CONNECT LINE TO PATIENT

a. Site/connect the infusion line to the patient. (Follow local policy for the recommended cannula and line to use). 11. START INFUSION

a. Press YES to commence the infusion when ready to do so. 12. CHECK AND CONFIRM THE INFUSION IS RUNNING

a. Visually check that: The infusion running screen is visible and the green light flashes intermittently. Place pump in lockbox and activate keypad lock if required, according to local policy.


4.3 LOCK ON Load and Prime

1. PREPARE THE SYRINGE a. Prepare syringe with drug (s) as per prescription and local policy, attach drug label.

When applying the drug label, ensure the label lies flat on the syringe. 2. CHECK THE PUMP a. Ensure that the device is clean, visually intact and appropriate for the intended use 3. INSERT THE BATTERY a. b. c.



a. b.


The automatic actuator movement will delete any previous programme in the pump memory. At the end of Pre-Loading the actuator returns to the start position of the last infusion programmed. The screen prompt “Load Syringe” will continue to flash until the syringe is correctly seated and detected.






7. REMOVE SYRINGE AND MANUALLY PRIME THE LINE a. Attach prepared syringe to the infusion set and manually prime the line 8. RE-LOAD SYRINGE a. Repeat section 6 9. RESUME OR NEW SYRINGE PROMPT a. Press the option required according to local policy:

Press “YES to Resume” (the delivery duration decreases). Press “NO for New Syringe” (the delivery will remain at the default duration (e.g. 24 hours).



To confirm infusion parameters, press YES 11. CONNECT LINE TO PATIENT a. Site/connect the infusion line to the patient. (Follow local policy for the recommended cannula and line to use). 12. START INFUSION? a. Press YES to commence the infusion when ready to do so. 13. CHECK AND CONFIRM THE INFUSION IS RUNNING a. Visually check that: The infusion running screen is visible and the green light flashes intermittently.


If purge required, press the FF key when the review infusion summary screen displays (step 10a) and before confirming parameters. Follow on-screen prompts.


4.4 LOCK OFF Prime and Load

1. PREPARE THE SYRINGE AND INFUSION LINE

a. Prepare syringe with drug (s) as per prescription and local policy, attach drug label.

When applying the drug label, ensure the label lies flat on the syringe. 2. MANUALLY PRIME THE LINE a. Attach prepared syringe to the infusion set and manually prime to remove all air from the syringe, set and cannula. 3. CHECK THE PUMP

a. Ensure that the device is clean, visually intact and appropriate for the intended use to ensure the device is working proper-ly before it is used on a patient.

4. INSERT THE BATTERY a. b.

c.



a. b.








8. REVIEW AND CONFIRM INFUSION PROGRAMME a. b. c. d. e.

Review pump configuration settings and wait for next screen prompt Volume: change if necessary, confirm by pressing YES Duration: change default duration if necessary, confirm by pressing YES (If the default duration is changed the screen prompt “Duration changed, please check rate” displays for a few seconds) Rate: displays the rate calculated from the syringe volume divided by the duration, check and confirm by pressing YES Review the infusion summary screen, press YES to confirm

9. CONNECT LINE TO PATIENT a. Site/connect the infusion line to the patient. (Follow local policy for the recommended cannula and line to use). 10. START INFUSION? a. Press YES to commence the infusion when ready to do so.

11. CHECK AND CONFIRM THE INFUSION IS RUNNING

a. Visually check that: The infusion running screen is visible and the green light flashes intermittently. Place pump in lockbox and activate keypad lock if required, according to local policy.

If purge required, press the FF key when the review infusion summary screen displays (at step 8e) and before confirming parameters. Follow on-screen prompts.


4.5 LOCK OFF Load and Prime

1. PREPARE THE SYRINGE AND INFUSION LINE a. Prepare syringe with drug (s) as per prescription and local policy, attach drug label.

When applying the drug label, ensure the label lies flat on the syringe. 2. CHECK THE PUMP

a. Ensure that the device is clean, visually intact and appropriate for the intended use to ensure the device is working properly before it is used on a patient.

3. INSERT THE BATTERY a. b. c.



a. b.






b. c. d.

e.




c. d.

Volume: change if necessary, confirm by pressing YES Duration: change default duration if necessary, confirm by pressing YES (If the default duration is changed the screen prompt “Duration changed, please check rate” displays for a few seconds) Rate: displays the rate calculated from the syringe volume divided by the duration, check and confirm by pressing YES Review the infusion summary screen DO NOT CONFIRM

8. REMOVE SYRINGE AND MANUALLY PRIME THE LINE a. Attach prepared syringe to the infusion set and manually prime to remove all air from the syringe, set (+/-) cannula.

9. RE-LOAD SYRINGE a. Repeat section 6

10. SELECT RESUME OR NEW SYRINGE a. From the 2 options available, either: (Press the option according to local policy)

Press YES to resume and the delivery duration decreases Press NO for new syringe and the delivery will remain at the default duration (e.g. 24 hours)

11. REVIEW AND CONFIRM INFUSION PROGRAMME a. Review the infusion summary screen, press YES to confirm

12. CONNECT LINE TO PATIENT a. Site/connect the infusion line to the patient. (Follow local policy for the recommended cannula and line to use).

13. START INFUSION? a. Press YES to commence the infusion when ready to do so.

14. CHECK AND CONFIRM THE INFUSION IS RUNNING a. Visually check that: The infusion running screen is visible and the green light flashes intermittently.


If purge required, press the FF key when the review infusion summary screen displays (at step 11) and before confirming parameters. Follow on-screen prompts.


4.6 LOCK OFF with maximum and minimum titration limits enabled

1. PREPARE THE SYRINGE







a. b.






b. c. d.

e.



7. REVIEW/ENTER INFUSION PROGRAMME Observe programme settings screen and wait for next screen to display

a. Volume: change if necessary, confirm by pressing YES b. Duration: change if necessary, confirm by pressing YES c. Rate: confirm by pressing YES d. Titration Maximum Limit: change if necessary, confirm by pressing YES e. Titration Minimum Limit: change if necessary, confirm by pressing YES f. Review the infusion summary screen (volume/duration/rate), confirm by pressing YES

8. CONNECT LINE TO PATIENT

a. Site/connect the infusion line to the patient.

Follow local policy for the recommended cannula and line to use. 9. START INFUSION?

a. Press YES to commence the infusion when ready to do so. 10. CHECK AND CONFIRM THE INFUSION IS RUNNING

a. Visually check that: The infusion running screen is visible and the green light flashes intermittently.

Place pump in lockbox and activate keypad lock if required, according to local policy. If purge required, press the FF key when the review infusion summary screen displays (step 7f)

and before confirming parameters. Follow on-screen prompts.

RATE CHANGE (TITRATION) DURING INFUSION

Remember to activate/de-activate keypad lock as necessary

1. With the infusion running, press and hold down the ↑ arrow key to increase the rate, press YES to confirm

2. Confirm that the rate entered displays and that the infusion time remaining corresponds to the rate change


4.7 RATE MODE

1. PREPARE THE SYRINGE



a. Ensure that the device is clean, visually intact and appropriate for the intended use to ensure the device is working properly before it is used on a patient.




a. b.






b. c. d.

e.



7. REVIEW/ENTER INFUSION PROGRAMME a. b. c.

Volume: change if necessary, confirm by pressing YES Rate: enter the rate required, confirm by pressing YES Review the infusion summary screen (volume/duration/rate), press YES to confirm

8. CONNECT LINE TO PATIENT

a. Site/connect the infusion line to the patient.

Follow local policy for the recommended cannula and line to use. 9. START INFUSION?

a. Press YES to commence the infusion when ready to do so.

10. CHECK AND CONFIRM THE INFUSION IS RUNNING

a. Visually check that: The infusion running screen is visible and the green light flashes intermittently.


If purge required, press the FF key when the review infusion summary screen displays (at step 7c) and before confirming parameters. Follow on-screen prompts.


4.8 RATE MODE with maximum and minimum titration limits enabled

1. PREPARE THE SYRINGE a. Prepare syringe with drug (s) as per prescription and local policy, attach drug label.



3. INSERT THE BATTER

t34 operation manual - sussex community · 2.19 kvo (keep vein open) ... remove the t34 syringe...

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