Operation Manual
36 Pages
Preview
Page 1
Operation Manual
TM CME TPCA Pain Management Syringe Pump Operation TM CMEMedical Medical TPCA Pain Management Syringe Pump Operation Manual Rev 1.2 May 2014 Manual Rev 1.2 May 2014
INDEX 1.0 INTENDED USE
3
2.0 WARNINGS, NOTES AND OPERATING PRECAUTIONS 3.0 SYMBOLS
3-4 5
TM
4.0 OVERVIEW OF THE TPCA PAIN MANAGEMENT SYRINGE PUMP
6
5.0 SYSTEM SAFETY CHECKS
7
6.0 PUMP INSPECTION AND ASSEMBLY (mains and battery power/bolus cable)
8-10
7.0 DESCRIPTION AND FUNCTIONS OF THE TPCATM PAIN MANAGEMENT SYRINGE PUMP
11-24
7.1 Pump Feature Recognition
11
7.2 Keypad Feature Recognition
11
7.3 Pump Programming
12
7.4 Security (Access codes)
12
7.5 Setting Up Protocols
13
7.6 Pump Main (Info) Menu
13
7.7 Change Set Up
14
7.8 View Set Up
14
7.9 Event Log
14
7.10 Bolus and Rate Delivery. Clinician Activated Bolus Facility
15
7.11 Bolus Dose Delivery
16
7.12 Rate Change (Titration) and Bolus Dose Change (Titration)
16
7.13 Purge Option
16
7.14 Syringes 7.15 Administration Sets
16-17 18
8.0 USER GUIDE
19-22
8.1 Starting a Protocol
19-22
8.2 Recommended Safety Checks During Infusion
22
8.3 Alarms and Alerts
23
8.4 Pump Stopped/Pause/Resuming a Protocol/Power Off
23-24
8.5 Troubleshooting
24
8.6 Changing a Syringe
25
8.7 Rate Change During Delivery (Rate Titration)
25
8.8 Bolus Dose Change During Delivery (Bolus Titration)
26
8.9 Delivering a Clinician Activated Bolus
26
9.0 Service and Maintenance
27
10.0 APPENDICES LIST
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1.0 INTENDED USE The TPCATM Pain Management Syringe Pump is intended to be used for any common infusion route including central/peripheral venous or subcutaneous. To minimise risk when administering infusions, dedicated administration sets are available. Colour coded sets are available to denote the intended route of drug administration. Please ask your local representative or contact us direct for further details. Please ensure the pumps are only used by, or under the supervision of trained medical staff. WARNING: Administration of drugs other than those indicated for IV use could result in serious injury to the patient.
2.0 WARNINGS, NOTES AND OPERATING PRECAUTIONS 2.1 WARNINGS AND NOTES Warnings and notes will be seen throughout this manual. These are described as: WARNING: Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to patient or operator. Read and understand this manual and all warnings completely before operating the TPCATM Pain Management Syringe Pump. NOTE: Indicates that the information that follows is additional important information or a tip that will help you when operating the TPCATM Pain Management Syringe Pump.
2.2 PRECAUTIONS ABOUT THIS MANUAL The operator must be thoroughly familiar with the TPCATM Pain Management Syringe Pump described in this manual prior to use, and in particular must read and understand any 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 specified 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.
OPERATING PRECAUTIONS This device complies with Part 15 of the FCC Rules. Operation is subject to the following 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 TPCATM Pain Management Syringe Pump has been designed and manufactured to exact specifications, it is not intended to replace trained personnel in the supervision of IV 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 infusion 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. 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. Drugs for infusion to be used with the pump may only be prescribed by a qualified medical practitioner.
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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, in accordance with the hospital/homecare provider’s disposal practices. 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. 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. 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.
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.0 SYMBOLS 3.1 SYSTEM SYMBOLS The following symbols are used on the TPCATM Pain Management Syringe Pump and components. Labels on the pump or statements in this manual preceded by any of the following words and/or symbols are of special significance and/or are intended to help you to operate the pump in a safe and successful manner.
PUMPSYMBOL IPX1
DESCRIPTION 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. Manufacturer.
SN
Serial Number.
Expiry Date (consumables).
LOT
Lot Number (consumables).
STERILE EO
Sterilized with Ethylene Oxide.
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.0 OVERVIEW This manual will assist the user to be able to: Identify the key features of the TPCATM Pain Management Syringe Pump and understand their functions Correctly load, detect and confirm a syringe is in place Programme the pump to deliver the contents of the syringe Be able to access and interpret patient history and event log data Be able to troubleshoot and resolve alarm conditions
4.1 WHAT IS THE TPCATM PAIN MANAGEMENT SYRINGE PUMP?
The TPCATM Pain Management Syringe Pump is a small protocol driven, lightweight, robust ambulatory syringe pump, operated from mains or using internal rechargeable Li-polymer battery giving up to 2 weeks ambulatory therapy on bolus only regimes. The pump incorporates active and passive safety features (configurable to local practice) and lockable protocols to prevent use or change by unauthorised personnel. Up to 6 protocols can be configured on the pump. Protocol settings and limits can only be changed by authorised personnel with pump connected to a computer. The settings can be configured in ml, mg/ml or mcg/ml to match the prescription ordered. Key features include three levels of security access codes (ensuring only authorised personnel can use the device and only senior personnel can change the pump set up or the pre-set clinical protocols), keypad can be locked to prevent tampering, down loadable patient and event history and automatic detection of a wide range of syringes from 2 to 60ml. The TPCATM Pain Management Syringe Pump can be pole mounted or ambulatory. A screw drives the pump actuator and syringe plunger forward at a controlled rate. This rate is adjustable from 0.1 to 650 ml/ h in increments of 0.1 ml/h up to 100 ml and 1 ml from 100 to 650 ml/h. The size and weight of the TPCATM Pain Management Syringe Pump makes it ideal for ambulatory use in either a hospital/ homecare/out-patient setting. It is equally suitable for adults or for paediatric use. The syringe pump can be easily concealed beneath clothing in a pouch fitted at either the chest (inside a jacket) or on the waist. It can also be pole mounted. The pump has a locking cover to protect against damage to or tampering with the pump or displacement of the syringe. The TPCATM Pain Management Syringe Pump offers three point syringe detection enabling the pump to identify all commonly used (or programmed) syringe brands and size. The sensors also activate an alarm if the syringe is removed or partially displaced during infusion. The pump may be used to deliver via any common infusion routes including central/peripheral venous and subcutaneous providing the medicines being administered are licensed for such use.
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5.0 SYSTEM SAFETY CHECKS The following details outline the safety checks designed into the pump to minimise the possibility of under or over infusions.
5.1 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 will check the line and attempt to clear the occlusion. During the occlusion the pump’s Post Occlusion Bolus Reduction System feature will reverse the operation of the motor and drive the actuator backwards to neutralise the pressure otherwise the pressure build up could cause a surge of fluid into the patient’ on release of the occlusion. When the protocol is resumed the user will notice that the volume to be infused (VTBI) increases and the volume infused (VI) decreases to indicate the pump back off feature. Therefore, the number of boluses (given) may not equal the volume infused.
5.2 PROTOCOL PROGRAMME LIMITS Protocols programme limits (basal rate or bolus dose) are configured via the BodyCommTM communications software. Users can choose from a number of options to limit protocol parameters and set safe ceilings on drugs infused. Authorised users will not be able to change the protocol or ceiling under Select Protocol and will have to select an alternative appropriate protocol or consult senior clinical staff with relevant authority. Alternatively you can choose to simply limit the number of boluses delivered over either a 1, 4, or 24 hour period according to local practice. After the senior clinical/lead service personnel programmes the protocols, they can be locked with the protocol lock. The TPCATM Pain Management Syringe Pump infusion protocols cannot be changed unless the healthcare provider re-enters the code and changes the protocols.
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6.0 PUMP INSPECTION AND ASSEMBLY 6.1 UNPACKING Remove the TPCATM Pain Management Syringe Pump and accessories from the packaging and inspect for damage during shipment or storage. Make sure you have the following items: TM TPCA Pain Management Syringe Pump Locking cover key Pump charger Operation manual Bolus cable Pole mount clamp Carry pouch (if purchased) WARNING: Do not use TPCATM Pain Management Syringe Pump if there are any obvious signs of damage. Return for inspection by authorised service personnel. If any items are missing or damaged, contact your supplies department.
6.2 POWER SUPPLY AND CHARGING The TPCATM Pain Management Syringe Pump can operate on mains or battery power. The battery is Li-Polymer 7.4V, 1800mAh, rechargeable. Battery power enables operation when the patient is being moved or during electrical power failure. When the pump operates on battery power, battery life of up to 2 weeks on bolus only regimes are possible.
6.3 MAINS POWER Pump operates on AC (mains) or backup battery power. Connection to AC (mains) power is recommended whenever possible.
6.4 BATTERY USE When fully charged, batteries can provide up to 100 full deliveries depending on infusion and set up parameters. Battery life may vary depending on settings, infusion rate, and the number of times the information options/screen backlight are used. Using the pump on mains power will extend the battery life. Leaving the battery in an uncharged state for long periods will shorten its life. After the End Battery signal appears, or following long periods of storage, wait two minutes after the pump has been connected to a mains power supply before operating.
6.5 SAFETY CHECKS It is good practice to inspect medical equipment and accessories between patients and certainly immediately before use (e.g. whilst setting it up on the patient). One of the issues with damage to cables or internal electrical components is that visual inspection will not always be able to identify this type of failure.
6.6 BATTERY AND CHARGING PRECAUTIONS
Replace the battery once every two years. After the “End Battery” signal has been activated or following long periods of storage, wait 2 minutes after the pump has been connected to an AC power supply before operating. Whenever possible, use the pump connected to an AC power. This preserves the battery power supply for emergency use or for situations where the AC power is not available. The pump is protected against overcharging. In order to keep your battery fully charged connect the pump to mains power whenever possible. Blown fuses could cause a fire hazard. Replace blown fuses on the charger only with fuses of the same type and rating (see fuse values on the charger PCB). Battery charging is enabled as long as the charger cord is connected to the mains and the pump. Switching the pump off does not disconnect it from the mains. To disconnect from the mains, remove the charger cord from the mains. WARNING: Only use accessories designed for the system. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the syringe pump distributor.
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6.7 TO CHARGE THE BATTERY Connect the charger plug into the mains and the DC connector into the pump DC port on the back of the pump.
CHECKING BATTERY LEVEL Checking Battery Level with no infusion running (LED light is red)
Load Syringe
Info Menu Press INFO key
Battery Level
Press YES:
Select +/-, Press YES
Battery Level
Load Syringe 80%
Empty
Full
Wait a few seconds for the screen to display:
Checking Battery Level with infusion running (LED light is green) A: Morphine 1mg Rate 0 ml/h Bolus 1 mg Lock out 5 mins Last bolus - mins Pump Operating
Battery Level 80%
Press INFO key twice: Empty
Full
Wait a few seconds for the infusion running screen to display.
NOTE: Last line alternates between “Pump Operating” and the syringe brand/size confirmed for the protocol. NOTE: Repeated key presses on the INFO key cycles through infusion running screen, volume history, battery level and infusion running screen.
6.8 BATTERY TEST When setting up the pump on a patient always check that there is enough battery charge remaining to cover the infusion duration. To do so follow one of the procedures below: Press INFO key when the pump is stopped to access the main menu and scroll to select Battery Level, press YES to view battery meter. During infusion press the INFO key twice to check Battery Level, in all cases verify sufficient battery charge is available to complete the current programme. If not, charge the battery. Sufficient battery charge may vary depending on your setting, infusion rate, number of times the information options/screen backlight are used. WARNING: Battery charging is enabled as long as the charger cord is connected to the mains and the pump is connected to the charger. Switching the pump off does not disconnect it from the mains. To disconnect from mains, remove the charger cord from mains. To disconnect pump from mains, disconnect it from the charger. WARNING: Voltage present on internal components may cause severe shock or death upon contact. Disconnect the charger from the mains, prior to opening the casing. Only trained service personnel should open the pump cover. WARNING: Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterizing equipment as this may result in false alarm signals or error messages being displayed. WARNING: Blown fuses could cause a fire hazard. Replace blown fuses on the charger only with fuses of the same type and rating (see fuse values on the charger PCB). WARNING: Leaving the battery in an uncharged state for a long period of time may damage the battery. NOTE: After the “End Battery“ signal has been activated or following long periods of storage, wait 2 minutes after the pump has been connected to an AC power supply before operating.
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6.9 ATTACHING THE PUMP TO THE POLE MOUNTING UNIT 1. Attach the pole mounting unit to a drip stand
2. Pull down the locking catch on the pole mounting unit and keep it held down
3. Insert the pump locator pins into the pole mounting locator holes
4. Release the locking catch The pump will now be securely locked into the pole mount
6.10 PATIENT BOLUS CABLE Connect the bolus cable connector to the pump bolus cable connector on the side of the pump. To deliver a bolus press the bolus cable button. Bolus delivery will commence on release. Coded hand switch with default settings for minimum and maximum pressing times and minimal pressing interval. Patient`s can easily identify when, bolus available, bolus is being delivered or bolus not available. The user action required to deliver a bolus dose is by pressing and releasing the bolus button, actual delivery of the bolus dose commences on release of the bolus button.
6.11 EQUIPMENT SAFETY CHECKS In clinical settings handsets/cables over time can be damaged by excessive force. As such handsets, and the attached cables, are part of the system most exposed and susceptible to damage. All CME infusion pumps feature software protection to mitigate the impact of bolus handset damage, thereby reducing the incidence of unrequested activation when a handset or cable is damaged. It is good practice to inspect medical equipment and related accessories between patients and certainly immediately before use (e.g. whilst setting it up on the patient). One of the issues with damage to cables or internal electrical components is that visual inspection alone will not always be able to identify this type of failure.
FOR HEALTHCARE PROFESSIONALS Prior to connecting the remote bolus handset cable to the pump, press the handset button - you should feel a click. If no click is felt when the button is pressed remove the remote bolus handset from use and return it to your medical engineering department or its authorised service provider for inspection. WHEN INSTRUCTING PATIENTS If, during use, the patient experiences or sees any of the following, they should inform their clinician immediately: They press and release the button to request a bolus (or register an attempted bolus depending on local policy) and feel no click and the pump does not deliver a bolus dose and/or emit a beep. They hear the pump emitting beeps (indicating bolus delivery or attempt) when they are not holding the handset and/or pressing the button. They see the handset exposed to anything that may have damaged it (stood on by a relative, trapped in bedframe, cable “tugged” violently, etc.) They notice any part of the system damaged (e.g. wires exposed, housing cracked, etc.) CME Medical TPCATM Pain Management Syringe Pump Operation Manual Rev 1.2 May 2014
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.0 DESCRIPTION AND FUNCTIONS OF THE TPCATM PAIN MANAGEMENT SYRINGE PUMP 7.1 PUMP FEATURE RECOGNITION 1
4 5
6
3 FEATURE
7
2
8
9 DESCRIPTION Protects against damage/tampering/displacement Protects against damage/tampering/displacement For connecting to BodycommTM communications software Secures syringe and detects brand and size Detects correct loading of syringe collar and measures volume in the syringe Drives the syringe plunger to deliver syringe contents Displays infusion and information data To unlock the locking cover Connects patient bolus cable to the pump
1. Nose cone 2. Locking cover 3. Infra-red 4. Barrel clamp arm 5. Collar sensor/syringe flange 6. Actuator 7. Six-line LCD screen 8. Key lock 9. Handset/bolus cable and connection
7.2 KEYPAD FEATURE RECOGNITION 2
8 5
3 7 1
4 6 9
FEATURE 1. ON/OFF 2. LED light
3. FF key (Forward)
4. BACK key (Reverse) 5. PLUS (+) 6. MINUS (-) 7. YES/START 8. NO/STOP 9. INFO
DESCRIPTION Switches the pump on and off A green indicator lights: (a) during system self-test (b) intermittently to indicate infusion delivery A red indicator lights: (a) continuously to indicate an alarm state (b) when on stand-by mode (a) moves actuator forward when no syringe in place and the barrel clamp arm is down (b) accesses purge function (if enabled) (c) accesses Clinician Bolus facility Moves actuator backward when no syringe is in place and barrel clamp arm is down (a) scrolls between options (b) increases infusion parameters during programming/titration (a) scrolls between options (b) decreases infusion parameters during programming/titration Confirms selection and starts infusion (a) stops infusion (b) takes user back a step during programming (a) repeated presses during infusion provides protocol information and battery level (b) when pump paused access the main menu (c) activates/deactivates keypad lock
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7.3 PUMP PROGRAMMING The TPCATM Pain Management Syringe Pump has several security features to ensure that unintended programming and key presses do not occur. Under normal, everyday circumstances most users of dedicated infusion pumps use the pumps to perform the same or a limited number of infusion protocols for the majority of patients. These pumps also have common default settings and parameters configured. For example, in pain management it is common for patients to be on a morphine regime consisting of bolus only delivery of a concentration of 1-2mg/ml morphine. The service may occasionally use different bolus volumes or lockout times depending on individual patient needs. This means once you have set up these protocols, Level One code users can access the pump and run the standard protocols for a patient without having to enter or change any infusion parameters. This reduces the risk of inadvertent changes of key parameters during set up.
7.4 SECURITY USER ACCESS CODES The TPCATM Pain Management Syringe Pump employs three levels of user access protection to prevent unauthorised changes to the set up or configuration. Once the pump has been switched on a Level One access code is required to select protocols, allow preloading, load the syringe and operate the pump. Settings and features may have been configured and locked as appropriate to the clinical application the pump is being used for in your practice. To programme and configure the TPCATM pump, a Level Three access code is required. Level One*
Allows user to run pre-set protocols and titrate infusion rate and bolus volume (if enabled and within pre-set pro tocol limits).
Level Two*
Allows authorised users to deliver Clinician Activated Bolus or loading dose.
Level Three * Allows users to set up or modify standard infusion protocols and change pump configuration parameters. * refer to senior clinical or lead service personnel for relevant codes.
A further technique and code is used to access the technicians menu but this is only provided to fully trained (by CME Medical) and authorised electrical biomedical engineering personnel. These authorised personnel can change the access code and the level of access. In normal use the nurse will not see these fields or be prompted for the technician code. Placing these settings in a secure area of the pumps menus also simplifies operation of the pump as everyday users are not required to repeatedly confirm or change common set up parameters whilst setting up a simple infusion regime. WARNING: Set up parameters should only be changed by clinical or technical staff with user code access rights only. If you are unsure about your authority to change these settings lease consult your clinical lead personnel or the local biomedical engineering staff. WARNING: Do not attempt to access code protected areas if you are not trained or authorised to do so. If authorised do not share the codes with un-authorised personnel. NOTE: A security access code must be keyed in to access the programming functions. This code is designed to allow access to the provider only. Only give the level of code access to the designated provider for the functions they will use in their clinical practise. To prevent a patient from tampering with programmed settings, this security code should not be given to the patient. NOTE: No access codes are contained in this manual. Please refer to senior clinical or technical staff for these codes ONLY if you have been trained and authorised to use them.
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KEYPAD LOCK The keypad has a locking feature that prevents unintentional power off of the unit. As well as the ability to lock or limit certain infusion parameters or pump settings, the TPCATM Pain Management Syringe Pump allows users to lock the operation of the keypad if concerned about patients, relatives or un-trained personnel tampering with the pump. To active the keypad Lock: 1. With the pump infusing, press and hold the INFO key until a graphic is displayed showing a bar moving from left (OFF) to right (ON). 2. Hold the key until the bar has moved completely across the screen and a beep is heard to confirm the lock has been activated. To turn the lock off repeat this procedure. The bar will now move from right (ON) to left (OFF) and a beep will be heard to confirm de-activation. NOTE: 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.
7.5 SETTING UP PROTOCOLS Full pump programming and setting up of protocols can only be carried out via the Bodycomm TM communications software either by CME Medical authorised personnel or designated, trained company/organisation staff. Up to a maximum of 6 infusion protocols can be set up for your service (CME Medical can pre-programme if requested). Only a limited number of device parameters can be changed via the pump in the change set-up option, a Level Three access code is required. Please refer to Appendices for pump and Bodycomm menus and data required to set up protocols. WARNING: Set up parameters should only be changed by clinical or technical staff with user code access rights only. If you are unsure about your authority to change these settings consult your clinical lead personnel or the local biomedical engineering staff.
7.6 PUMP MAIN (INFO) MENU To access the pump main menu, with pump stopped, press the INFO key to display these options: Use the + or - keys to scroll up/down the menu. The current selection is indicated by an arrow and the text is slightly larger than the other choices. Press YES to view the selected option.
BATTERY LEVEL Shows the battery level as a percentage. The battery level can also be viewed via the INFO key during infusion checks. Refer to pages 8 to 10 for further information on mains power and battery use.
=> Battery Level Protocol Lock Change Set-Up
PROTOCOL LOCK If enabled, this prevents alteration of protocol. If disabled in pump set up, this option will not be visible.
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7.7 CHANGE SET UP Several pump settings can be set via “change set up”, this area is accessed by entering the Level Three access code and should only be accessed by staff who are trained and authorised to do so. This is only available by accessing the extended menu (see over). (Refer to page 30 for Change Set Up options). WARNING: The following instructions will affect the operation/functionality of the TPCA TM Pain Management Syringe Pump for all infusions. Set up parameters should only be changed by clinical or technical staff with user code access rights only. If you are unsure about your authority to change these settings please consult your clinical lead personnel or the local WARNING: Do not change any parameters unless you clearly understand the significance of that parameter and the effect your change will have on the operation and/or functionality of the pump.
TO CHANGE DEFAULT PARAMETERS: 1. Select Change Set Up from the extended menu, press YES to confirm. 2. The user will be prompted for an access code, enter the access code required. 3. Scroll to select a desired parameter and press YES to view. 4. Adjust the parameter by using the +/- keys, press YES to confirm changes 5. Repeat steps 3 and 4 as necessary. NOTE: Only a limited number of pumps settings can be changed via the pump. To fully programme the pump with configurable settings and protocols, the BodyCommTM communications software must be used. NOTE: When the UP arrow is held down the pump will count up in single digits to ten, then in tens to one hundred and then in hundreds thereafter. Scroll to the nearest point in tens and then release the key. Press the key again, (UP or DOWN arrow) depending on digit displayed on the screen, to select the final correct code. Press YES to confirm the code. NOTE: If you enter the wrong code wait for a few seconds and the pump will default back to enter code screen. NOTE: Access codes are not given in this manual, please consult your senior clinical personnel or biomedical engineers.
7.8 VIEW SET UP This screen displays the pump parameters activated in the main menu: This screen also displays as part of infusion running safety checks during an infusion. 1.
When a protocol/infusion is running, press the INFO key repeatedly until this screen displays.
01. Feb. 2009 10:15 Occlusion 540 mmHg Titration Enabled Battery Status 88% ID: ……………………….
7.9 EVENT LOG The Event Log shows a complete time and date stamped record of the last 512 pump events along with a record of pump status (volume infused, rate, etc) at the time of the event. Event log data cannot be deleted or altered.
TO VIEW THE EVENT LOG: 1.
Press STOP to temporarily interrupt the infusion (if running)
2.
Press the INFO key to access the main menu, use the +/- keys to scroll to ‘Event Log’. Press YES to confirm selection.
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3.
Screen displays the most current event, alarm, date, time, etc. Use the Up and Down arrow keys to scroll through events to find the event of interest (e.g. an alarm or programming change).
4.
Press INFO when on any chosen event to display further data regarding this event. The user can scroll through the information using the Up and Down arrow keys to check, for example, how the pump was set up, whether keypad lock was ON and the pressure settings. NOTE: Each event is assigned a number and the pump stores the last 512 in the memory. The event log “loops” adding the newest and deleting the oldest event.
7.10 BOLUS AND RATE DELIVERY. CLINICIAN ACTIVATED BOLUS FACILITY The TPCATM Pain Management Syringe Pump can be configured to deliver a patient controlled bolus, a continuous (basal) rate or a combination of both. These different protocols will be set by your Lead Clinician as appropriate to your clinical setting and the pump programmed by either CME Medical or designated local staff. The clinician activated bolus facility can be enabled in any mode of operation.
PATIENT CONTROLLED BOLUS This mode is used to deliver a pre-set patient bolus dose. The dose is activated by the patient pressing and releasing the bolus button. A patient-controlled bolus can only be activated via the remote bolus button. There is also a facility to limit amount of boluses within a 24 hour period. If a bolus has been programmed into a regimen it will always include the following parameters: 1. Bolus volume – the volume of drug to be delivered in each bolus event. When the bolus button is pressed the pump will beep to confirm acceptance and a syringe graphic will appear on the display confirming bolus volume to be delivered and progress as the pump delivers it. 2.
Lock Out – the lockout time which must elapse after a bolus dose has been delivered before the pump will allow another bolus dose. If the patient presses the bolus button during the Lock Out the pump will beep to confirm the press but no syringe graphic is displayed and the pump continues with the back ground Infusion (if programmed). Users can check the bolus summary for the patient by pressing the INFO key to view the Bolus Summary screen. On the running screen last bolus (in minutes) is displayed.
CONTINUOUS (BASAL) RATE This allows rate parameters to be set in the protocol and only an authorised user can titrate within these parameters. Maximum default basal rate is 99ml/h (Range 0.1-650ml).
RATE PLUS PATIENT CONTROLLED BOLUS This mode allows both a rate and patient bolus activation at the same time with pre-set parameters.
CLINICIAN ACTIVATED (CA) BOLUS During certain pain management protocols it may be necessary for the clinician to administer loading dose or top up bolus outside of the parameters of a standard protocol. A Clinician activated bolus can be given prior to, or during an infusion. Lead personnel can limit the maximum clinician dose under Change Set Up to prevent accidental overdosing. Default setting is 1ml for a single dose but this can be configured between 0ml (disabled) to 25ml maximum. If an initial Clinician activated loading dose needs to be given, deliver the loading dose immediately after the pump has been set up for that patient. This will then be recorded in the current patient history. The number of doses and total volume can be seen NOTE: If the user requests a dose above the default or configured maximum clinician dose the pump will display the maximum single dose available and the user should then re-enter within this limit. WARNING: Clinician Activated Bolus overrides programme limits. Take care to ensure only trained, authorised personnel have the required code and understand the function of this feature. WARNING: If an occlusion occurs or the pump is stopped during clinician bolus delivery the user will have to repeat the above steps to deliver the balance of the Clinician Activated Bolus. WARNING: Make sure you fully understand all of the possible modes especially the one your pump is configured to before operating the TPCATM Pain Management Syringe Pump. CME Medical TPCATM Pain Management Syringe Pump Operation Manual Rev 1.2 May 2014
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7.11 BOLUS DOSE DELIVERY The TPCA syringe pump has a feature which optimises bolus delivery speed and prevents false occlusion alarms when infusing through infusion sets. The pump attempts the bolus at the pre-set bolus rate. If a back pressure above the pre-set occlusion pressure level is detected during delivery it reduces the delivery speed until a pressure below the occlusion alarm level is achieved. If it cannot achieve this even at the minimum bolus delivery rate the pump will then alarm ‘Down Occlusion’. This feature prevents false occlusion alarms during bolus delivery through narrow bore infusion sets. The patient bolus can be interrupted i.e. by an authorised user or if the pump has gone into an alarm status, when the pump is restarted the patient bolus is not automatically reactivated. If the patient presses and releases the bolus button within the lockout time the remaining amount of the interrupted bolus is delivered. NOTE: The TPCATM Pain Management Syringe Pump is capable of delivering the bolus dose at a rate of up to 1000ml. Bolus delivery set up is via the BodyCommTM communications software. NOTE: Titration requires two separate, distinct actions, this helps to protect against accidental titration if the keys are nudged or tampered with during infusion.
7.12 RATE TITRATION AND BOLUS DOSE TITRATION RATE TITRATION Rate titration can be enabled so that the authorised user can adjust the continuous rate within a protocol. Pre-set maximum (max.) and minimum (min.) limits can be set in the protocol. The programming of these parameters can only be set up via BodyCommTM communications software but can be enabled or disabled via the pump, via the Change Set Up option by authorised users with level three access code.
BOLUS DOSE TITRATION Bolus titration can be enabled so that the authorised user can adjust the continuous bolus dose within a protocol. Pre-set maximum (max.) and minimum (min.) limits can be set in the protocol. The programming of these parameters can only be set up via BodyCommTM communications software but can be enabled or disabled via the pump, via the Change Set Up option by authorised users with level three access code.
7.13 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 programmed infusion rate) the user can purge the system (once only prior to commencing a protocol) up to a volume limit configured via the BodyCommTM communications software (max 0.5 ml). When the system is purged, this will reflect in the total deliverable volume. The Purge option is only visible to the user if enabled in the protocol. The programming of these parameters can only be set up via BodyCommTM communications software but can be enabled or disabled via the pump, in the Change Set Up option by authorised users with level three access code.
7.14 SYRINGES DEFAULT SYRINGE BRANDS AND SIZES The TPCA syringe pump is calibrated to operate with most commonly used LUER LOCK syringes and programmed to recognise most commonly used syringes from 2 ml to 60 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.
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Pump default syringes are: BD Plastipak Braun Omnifix Codan/ONCE Monoject Terumo It is recommended that all but the brand of syringe in regular use are disabled per the BodyCommTM communications software to prevent accidental selection of the incorrect brand during set up. Should the need arise to programme the TPCATM Pain Management Syringe Pump to operate with a manufacturer and/or brand other than one of those listed above you should consult either your local, certified service centre or the distributor for further information. 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: Standard pre-filled PCA preparations are commonly supplied in 50/60ml syringes so the locking cover is configured primarily for these syringes sizes. Although smaller syringes may be used they may not be protected by the locking cover and could more easily be removed. WARNING: Some manufacturers have several brand names within their ranges (e.g. Braun Omnifix and Braun Perfusor). Please only use the brands named above with the TPCATM Pain Management Syringe Pump as failing to do so could result in an under or over infusion. NOTE: If the pump fails to recognise a syringe it may be that it has not been positioned correctly/fully. Reseat the syringe. If the problem persists, the syringe brand/size being fitted is not 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: Braun 2ml, Codan 2.5ml and Monoject 6ml syringes exhibit a slight undeliverable volume of 0.1ml due to their design. The TPCATM Pain Management Syringe Pump will display the volume as “VOLUME 2.4 (of 2.5ml)”. In this example the pump can only deliver 2.4ml of the 2.5ml in the syringe and when the pump has driven as far forward as possible 0.1ml will WARNING: Never connect to the patient before loading the syringe into the pump. WARNING: Component damage may occur if the set is not correctly attached to the syringe. Assure all connections are secure; do not over tighten. This will help minimise leaks, disconnection and component damage. WARNING: Air embolism during an IV infusion can cause death or serious injury to the patient. Do not connect a patient to the TPCATM Pain Management Syringe Pump until all air has been cleared from the fluid path and syringe. Puncturing set components could result in air embolism. Completely prime the administration set before loading the syringe into the pump. 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: 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: Disposables must be compatible with the medicine delivered. Please check with the manufacturer of the giving set before use. WARNING: Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied by CME Medical. 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 single use sets.
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7.15 ADMINISTRATION SETS The TPCATM Pain Management Syringe Pump can be operated with any extension set with a Luer connection however, it is recommended, to optimise system accuracy and performance, that proprietary sets from CME Medical are used. Please refer to page 33 for ordering contact details. Please refer to pages 17 (section 7.14) for additional Warnings, Cautions and Notes relating to consumables. PRODUCT CODE Micro set 100-172SB Micro set 100-172S
Micro set 100-172-SC
FEATURES Syringe extension set – blue stripe DEHP, latex free Anti kink tubing with check valve, female luer lock Length approx 2m, priming volume approx 0.7ml Syringe extension set- clear DEHP, latex free Anti kink tubing with check valve, female luer lock Length approx 1m, priming volume approx 0.5ml Syringe extension set with blue stripe and needle-free access port DEHP, latex free Anti kink tubing with check valve, female Luer lock Length approx 1m, priming volume approx 1m
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: Replace the administration set in accordance with local guidelines to reduce the possibility of infection.
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0 USER GUIDE 8.1 STARTING A PROTOCOL The sequence for starting a protocol is: Syringe selection and priming the giving set Power up and select a protocol Review syringe sizes enabled Pre-Loading Syringe loading, detection and confirmation Purge system slack (if enabled) Confirmation of deliverable volume Verification of protocol selection Confirmation of infusion running NOTE: For the purposes of illustration all operating modes and features/functions, (using pump default settings) are covered in the following guides. When the pump has been set-up and protocols have been configured to local requirements the start up sequence and functions/facilities available will vary. If a protocol is selected which has not been programmed with any of these features and facilities, they will not be available or appear during operation.
Syringe selection and priming the giving set 1. After filling the syringe and attaching the drug label, attach the giving set and prime the line manually. 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 connect the syringe/line to the patient before loading the syringe into the pump.
Power up and select a protocol 2. Press ON/OFF key to power the pump up. Open the locking cover with the key. NOTE: Before powering up, ensure the locking cover is open, no syringe is loaded and the barrel clamp arm is down. Screen during pump self test displays: a) Pump model name b) Software version c) Pump ID
PAIN MANAGER SYRINGE PUMP SV: PCAUK:011008 ID: Syringe Pump
(This screen displays for a few seconds and moves automatically) NOTE: Pump ID can be configured to local requirements e.g. asset no. or user site, up to a maximum of 17 digits.
3. To confirm authorisation of the user, enter the relevant code by using the +/- keys, press YES to confirm. (If the wrong code is entered, wait a few seconds and the pump will return to enter code screen).
Enter Level 1 Code
0 Set +/- and Press YES
4. The pump is prompting the user to their intention:
Pressing YES to Resume will retain previous infusion history
Pressing NO for New Therapy will delete infusion history
Press YES to Resume NO for New Therapy
For the purposes of this example, press NO for New Therapy. 5. To access the protocols menu screen, the user must take the Protocol Lock OFF: Use either the +/- key, to display “Lock OFF”, press YES to confirm.
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Protocol Lock ON Select +/- , Press YES
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6. To select the protocol required: Using the + or - keys scroll through the menu to select the protocol that matches the prescription ordered, press YES to confirm. (user has a selection from A to F, if enabled). 7. Read and confirm the Protocol summary screen: ENSURE THE PROTOCOL DISPLAYED MATCHES THE PRESCRIPTION, press YES to confirm.
8. Read and confirm the Bolus summary screen: ENSURE THE PROTOCOL DISPLAYED MATCHES THE PRESCRIPTION, press YES to confirm.
Review syringe sizes enabled
SELECT PROTOCOL
A: Morphine 1mg B: Morphine 2mg
A: Morphine 1 mg Conc. 1mg/ml Rate 0 mg/h Min 0 mg/h Max. 0 mg/h Bolus rate 400ml/h Lock out 5mins Bolus dose 1mg (0-2mg) PRESS YES TO CONFIRM
Syringes sizes enabled for the protocol will display: 9. From the selection available, ensure the syringe size you are using is displayed on the screen, press YES to confirm.
Syringe Sizes Enabled 50-60 ml PRESS YES TO CONFIRM
Pre-Loading 10. Observe automatic actuator movement (pre-Loading) and wait until the actuator stops moving:
Pre-Loading PRESS NO TO STOP
NOTE: Once the syringe sizes enabled have been confirmed the pump will automatically pre-load. During Pre-loading the actuator returns to the start position of the last infusion programmed. If the healthcare provider regularly uses the same syringe brand, size and fills to the same volume the actuator should return to the correct position and not require adjustment. During pre-loading (automatic actuator movement) two screens display automatically: 26/11/2008 16:45 The settings summary screen displays locked parameters to restrict the programming of the pump.
This screen confirms completion of automatic actuator movement and prompts the user to load the syringe. The “Load Syringe” screen displays and flashes in three places until syringe loading is complete.
Occlusion 540mmHg Titration Enabled Battery Status 79%
Load Syringe
WARNING: The actuator can only be moved as described above. Do not use force to try to move the actuator manually as this could damage the device and/or affect calibration. 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.
Syringe loading, detection and confirmation 10. To align and fit syringe: Ensure the barrel clamp arm is down, hold the syringe above the sensor fitting areas matching syringe collar to collar sensor and syringe plunger to the plunger sensor Use FF/back key as necessary to move the actuator to the required position (forward movement of the actuator is limited for safety reasons so repeated presses of the FF key may be required. Backward movement is not restricted) Lift the barrel clamp arm and position the syringe into the flange/collar sensor and the plunger sensor simultaneously. Lower the barrel clamp arm to sit on top of the syringe barrel As you correctly seat each point of the syringe the flashing indicator for that sensor becomes solid on the screen display, when all three sensors have detected the screen displays the size and brand of the syringe. CME Medical TPCATM Pain Management Syringe Pump Operation Manual Rev 1.2 May 2014
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