BodyGuard 595 Operation Manual Rev 2.3 October 2013

CONTENTS NO

DESCRIPTION

PAGE

1.0

BODYGUARD PUMP OVERVIEW

3

2.0

PUMP DESCRIPTION AND FUNCTIONS

4-6

3.0

SYSTEM SAFETY CHECKS

7

4.0

SYMBOLS AND LABELS

8

5.0

INTENDED USE, WARNINGS, NOTES AND PRECAUTIONS

9-10

6.0

INSTALLATION AND SET-UP (Including Battery Charging and Powering Up)

11-12

7.0

OPERATING THE BODYGUARD PUMP

13-32

7.1

Security: Access Codes and Keypad Lock

13

7.2

Setting Up and Modifying Protocols

14-17

7.3

Administration Sets

18

7.4

Loading the Administration Set

19

7.5

Powering Up and Priming a Set

20

7.6

Selecting a Protocol

21

7.7

Interpreting Display Screen Whilst Infusing

22

7.8

Rate Change During Delivery (Rate Titration)

22

7.9

Bolus Dose Delivery: Patient Controlled/Clinician Activated

23-25

7.10

End of Infusion and Bag Change

26

7.11

Using History Functions: Current Patient and 512 Event log

27-28

7.12

Eliminating Air During Operation

29

7.13

Alarms, Alerts and Troubleshooting

30-31

7.14

Review Pump Set Up

32

7.15

Change Pump Set Up

32

7.16

Keep Vein Open (KVO)

32

7.17

MAINTENANCE AND SERVICE

33

8.0

APPENDICES

34-44

10.0

INDEX

45

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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1.0 BODYGUARD PUMP OVERVIEW The BodyGuard™ 595 Regional Analgesia Infusion Pump provides the following:

Multiple programmes 

Bolus only (Patient Controlled (PCA))



Continuous (basal) plus patient controlled bolus



Continuous only analgesia

Used for ambulatory care, can be pole mounted or used with a carrying pouch

A small, light and compact pump with quiet operation

+/- 5% accuracy, even at low infusion rates

Rechargeable Li-Polymer internal battery and mains operations

Battery charged in a pole mount charging cradle or with an A/C adaptor

Free-flow protection integral to all administration sets (anti-siphon/reflux)

Prevents false occlusion alarms when delivering boluses through narrow catheters by automatically varying bolus delivery rate

Post-occlusion bolus prevention system

MediGuard™ protection ensures protocol is appropriate to patients weight

512 Event Log plus detailed patient history (1024 events log is optional)

Ability to output history to PC (printer or file) using BodyComm™ communications software (optional)

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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2.0 PUMP DESCRIPTION AND FUNCTIONS FRONT OF BODYGUARD PUMP

1

2

3 4 5

10 6 7 8

9

1. DISPLAY SCREEN a. Displays pump/infusion status b. Displays programming choices and instructions 2. UP ARROW a. Scrolls up through options on menu screens 3. START/OK a. Confirms parameter selection b. Starts infusion 4. STOP/NO a. Stops infusion/bolus b. Silences an alarm condition c. Stops priming d. Zeroes the displayed value during programming e. Erases the last digit during programming f. Returns to previous screen g. Returns to main menu when held down for 2 seconds after stopping infusion delivery 5. BOLUS a. Administers bolus dose during PCA regimes (this function is normally performed using the remote bolus cable) b. Activates clinician (CA) bolus when pump in STOP mode. (Can only be activated under code conditions)

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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6. POWER ON/OFF a. Turns the pump on by pressing and holding the key until the software version confirmation screen appears and a beep is heard b. Turns the system off by pressing and holding the key until the graph is black and a beep is generated

7. LED window (beneath the bolus and on/off keys) a. Green indicator - Lights during system self-test - Intermittent green light indicates infusion delivery b. Red indicator - Indicates an alarm state with a continuous red light - Lights when the pump is in a stand-by mode during programming 8. INFO a. When pressed during infusion displays: - Infused volume and total to be infused - Battery status - Bolus attempts, given and Clinician Bolus volume - Protocol review screen - Date and time b. Press STOP/NO and then INFO to access: - Volume and boluses given in the last 24 hours - Hour-by-hour utilisation data - Hour-by-hour chart of bolus demand in last 24 hours - Hour-by-hour chart of volume infused in last 24 hours c. Holding the INFO key down whilst the pump is infusing (until the graph displayed turns black), locks and unlocks the keypad to prevent accidental or deliberate changes to pump operation

9. DOWN ARROW a. Scrolls down through options on menu screens

10. NUMERICAL KEYS a. Enters numeric parameters during programming b. Enter access code

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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BODYGUARD PUMP WITH DOOR OPEN 1 6 2 7

3 4 5

No.

Area

Function

1.

Door latch

Opens the door and holds it closed when latch is in vertical position

2.

Pressure sensor

Detects downstream tubing restriction and occlusion (behind keyway)

3.

Keyway

Guides the administration set into correct position and ensures only dedicated administration sets are used

4.

Pressing plate

Helps keep tubing in place in tubing chamber. Connected to the door by two springs

5.

Pump door

Covers the pressing plate

6.

Flow direction

Shows direction of fluid flow

7.

Ultrasonic air sensor

Detects air bubbles in tubing

BODYGUARD PUMP IN CHARGING UNIT Charger display Displays major pump messages and operation values

Release handle Push to release the pump from the charging unit

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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3.0 SYSTEM SAFETY CHECKS The following details outline the safety checks designed into the BodyGuard™ pump to minimise the possibility of under or over infusions.

FREE FLOW PROTECTION When the set is installed in the pump and the door closed, two ridges on the door clamp the set so only the movement of the motor pistons can allow fluid to pass. With the door open, protection is afforded by a check valve, present in all BodyGuard™ sets, that prevents free flow towards the patient when the set is not attached to the pump. When the pump is attached to the set and delivering fluid, the pressure delivered by the pump opens the valve. The check valve also prevents reflux. The design of the check valve means that although a pressure of 2-3psi can open the check valve in the direction of the patient, reflux cannot occur regardless of the pressure that builds up in the set.

POST OCCLUSION BOLUS REDUCTION SYSTEM During an occlusion, pressure in the downstream section of the line can build up to 21psi (depending on user defined settings). When the pump alarms the user will check the line and attempt to clear the occlusion. In the absence of Post Occlusion Bolus Reduction System the pressure build up could cause a surge of fluid into the patient. This feature works by reversing the operation of the motor until pressure in the downstream line is returned to neutral (usually within 15 seconds).

AIR-IN-LINE DETECTION The BodyGuard™ pump utilises two modalities to detect air-in-line. The ultrasonic detector can be configured between 0.0 (OFF) and 1.0ml on the BodyGuard™ pump for single bubble detection whilst a cumulative check triggers the alarm if an accumulation of smaller bubbles totals 1.0ml (non-configurable) in any 15 minute period. Although a single bubble may not exceed the user defined threshold (e.g. 0.5ml) if the cumulative volume of smaller bubbles exceeds 1ml (e.g. if three 0.4ml bubbles pass the sensor within a 15 minute period) an ‘Air/Up Occlusion’ alarm is activated. This accumulation feature is particularly useful when infusing products that create a significant number of small air bubbles (out-gas) to a patient who is highly sensitive to air i.e. infants, neonates, children. If OFF (0.0ml) there is a 3ml volume for air in line detection.

PROGRAMME LIMITS (including MediGuard™ toxicity settings) Under ‘Change Set Up’ users can choose from a number of options to limit protocol parameters and set safe ceilings on drugs infused. When the MediGuard™ feature is on users are asked to set the patients weight (kg) and a toxicity ceiling in either ml, mg or mcg (depending on pump configuration) per kilogram bodyweight per hour. If users try to set a protocol where the component elements (basal rate and boluses) exceeds the MediGuard™ limit the pump will alert the user to this and request they re-confirm their intentions, amend or revise the toxicity ceiling. Level One 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 Level Three authority. Alternatively you can choose to simply limit either the rate or number of boluses delivered over either a 0, 1, 4, or 24 hour period according to local practice.

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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4.0 SYMBOLS AND LABELS The following symbols are used on the BodyGuard pump, accessories and consumables. Labels on the pump or statements in this manual preceded by any of the following words and/or symbols are of special significance, intended to help you to operate the pump in a safe and successful manner.

IPX3

Symbol for degree of protection against ingress of water

Symbol for type of protection against electric shock - Class II equipment

Attention, consult accompanying instructions

CE mark indicates conformance to Medical Device Directive 93/42/EEC 0344 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 Serial number

Expiry date of disposable

LOT STERILE

Lot number

EO

Sterilised with Ethylene Oxide

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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5.0 INTENDED USE, WARNINGS, NOTES AND OPERATING PRECAUTIONS INTENDED USE The BodyGuard™ 595 Regional Analgesia Infusion Pump is designed for patients who require nerve block or wound infiltration pain management. CME Medical recommends dedicated pumps for differentiation between nerve block, epidural and IV administration to prevent medication errors. The BodyGuard™ pump is also available in both a PCA and colour-coded epidural format. 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.

WARNINGS AND NOTES Warnings and notes will be seen throughout this manual. These are described as:

WARNING: Warnings advise of circumstances that could result in injury or death to the user/operator or circumstances that could result in damage to the device. Read and understand this manual and all warnings before operating the BodyGuard 595 Regional Analgesia Infusion Pump .

NOTE: Indicates that the information that follows is additional important information or a tip that will help you recover from an error.

PRECAUTIONS ABOUT THIS MANUAL •

•

The operator must be thoroughly familiar with the BodyGuard™ 595 Regional Analgesia Infusion 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 operating 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.

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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OPERATING PRECAUTIONS  Although the BodyGuard pump has been designed and manufactured to exact specifications, it is not intended to replace trained personnel in the supervision of pain management 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 or immerse into liquid. 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. • The BodyGuard pump should be operated within a temperature range of +18ºC (+59ºF) to +45ºC (+113ºF) and up to 85% humidity. Operating the pump at temperatures and/or humidity other than within that range may affect accuracy.  Do not operate the pump near high-energy radio-frequency emitting equipment, such as electrosurgical cauterising equipment. False alarm signals may occur.

INFUSION PRECAUTIONS  Always read and follow the instructions which accompany the administration sets. Carefully follow the instructions for priming the set, as well as the recommended set change interval.  The fluid bag 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.  Drugs for infusion by use of the pump may only be prescribed by a qualified medical practitioner.  Caution must be exercised in the selection of drugs and the amount and rate intended to be delivered via any infusion pump.  If the drug contained in the fluid bag 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 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.  Disposables must be compatible with the medicine delivered.  When operating the pump on patient controlled programme with a rate of 0.00ml/h there is a hazard of blood clot forming. Connecting a clear fluid infusion in parallel will avoid this problem.

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.

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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6.0 INSTALLATION AND SET-UP PLACING AND REMOVING THE PUMP FROM THE CHARGING UNIT NOTE: Before using the BodyGuard pump ensure the battery is fully charged PLACING THE PUMP INTO THE CHARGING UNIT

Put the pump into the charger top first until it clicks into place

REMOVING THE PUMP FROM THE CHARGING UNIT

Press the pump release button to lift the pump out of the charger bottom first

CHARGING THE PUMP Connect the charger unit to AC power, the AC power indicator will be amber Battery charging status Indicator Verify that the indicator is lit: Green light = fully charged battery Red light = battery charging

BATTERY AND CHARGING PRECAUTIONS Be sure that the battery is fully charged at all times. Replace the battery once every two years. When the pump is not in use store the pump in the charger. 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.  Do not operate the pump on AC power if the battery is not loaded in the pump for back up.  Whenever possible, use the pump connected to an AC power supply via the charging unit. 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 the mains via the charger 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 is in the charger unit. Switching the pump off does not disconnect it from the mains. To disconnect from the mains, remove the charger cord from the mains. 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.    •

CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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MAINS POWER AND BATTERIES The BodyGuard pump is powered by an AC (mains) power source. The pump uses external rechargeable 1800mAh Li-Polymer/Li-ion battery as an alternate power source. To assure continuous operation, the pump will switch from AC to battery power automatically in the event of AC power interruption. The pump also switches to battery power when disconnected from AC power. For example, if the patient needs to ambulate, you can disconnect the pump from AC power and it will automatically continue operating on battery power until reconnected to AC power. MAINS POWER AND BATTERY USAGE  Do not operate the pump on AC power if the battery is not loaded in the pump for back up.  The pump is protected against overcharging. In order to keep your battery fully charged, connect the pump to the mains via the charger whenever possible.  Switching the pump off does not disconnect it from the mains. To disconnect from the mains, remove the charger cord from the mains.  Whenever possible, use the pump connected to an AC power supply via the charging unit. This preserves the battery power supply for emergency use or for situations where the AC power is not available.  Battery charging is enabled as long as the charger cord is connected to the mains and the pump is in the charger unit.  Replace the battery once every two years.  Always make sure that the pump’s rechargeable battery is fully charged before using the pump.  A fully-depleted external rechargeable 1800mAg Li-Polymer/Li-ion battery takes about six hours to recharge. The battery level does not have to be empty for the battery to be recharged.  To avoid complete loss of power, check the battery level frequently and recharge the battery if needed using a BodyGuard pump battery charger.  When the Low Battery alert condition occurs, connect the pump to the charger as soon as possible. You have about 30 minutes before total loss of battery power.  When the End Battery alarm condition occurs, connect the pump to the charger immediately otherwise the battery will fail imminently.  When the pump is not in use store the pump in the charger.  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.

FACTORS THAT AFFECT BATTERY LIFE The actual battery life you experience depends on many factors. These factors vary among pump users, according to how and under what conditions they use the pump. Factors that affect battery life include:  Age of battery  Infusion flow rate  Other programmed infusion parameters  Which pump features are used  Ambient temperature in which pump is used  How often the pump display screen backlight is used  How long the pump is left on, in Standby mode  How long the battery is left uncharged before recharging 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: 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. CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.0 OPERATING THE BODYGUARD PUMP 7.1 DEDICATED BODYGUARD ADMINISTRATION SETS Only dedicated BodyGuard administration sets should be used with BodyGuard pumps. All BodyGuard micro sets incorporate the following features:   

 

Latex-free, micro bore anti-kink tubing to prevent occlusion particularly in ambulatory configuration. Colour-coded to aid identification of administration route. Pumping segment non-colour coded, section containing the key block, visible on the pumping segment ensures set can only be installed correctly (for direction of flow) and that only dedicated sets (calibrated to the pump to ensure accuracy) are used Check valve (anti-siphon/anti-reflux) at the distal end of the set Choice of straight or angled spikes

Straight spike

Angled spike 230cm, colour coded, intravenous administration spike set with approximate 5ml priming capacity. ANTI-FREE FLOW VALVE The Anti-Free Flow valve enhances pump functioning by: ° Preventing free-flow in the event the set is detached from the pump ° Preventing back-flow (reflux) in the event several infusion pumps are connected simultaneously to the same patient ° Preventing free-flow in the event of a mechanical malfunction ° The mechanism along the inner door side of the pump maintains optimal accuracy even if the line is used over several days WARNING: BodyGuard sets are designed specifically for ambulatory use. They have a set capacity of c.5ml for safety reasons. Normal hospital lines can hold up to 16ml of fluid which is not appropriate when administering potent drug agents. Non-colour coded sets are available on request. WARNING: Use of administration sets other than dedicated sets may impair the operation of the pump and accuracy of infusion. Do not operate the BodyGuard pump with any set other than those supplied by CME Medical or through their distribution partners. WARNING: All BodyGuard dedicated administration sets incorporate sections of PVC tubing and the pumping segment is polyurethane/silicone. Do not use pharmaceuticals with this device that are not compatible with either PVC or polyurethane administration sets.

NOTE: A kinked/occluded administration set may impair operation of the pump and the accuracy of the infusion. Before operation, verify that the set is not kinked or occluded. BodyGuard sets are manufactured from kink resistant tubing. CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.2 LOADING THE ADMINISTRATION SET

1. Prepare fluid bag and attach to administration set. 2. Open the BodyGuard pump door (using latch on right side of door). 3. The clear, silicone section of the administration line fits into the pump. Hold this section of tubing with the key (small plastic block) on the right and make sure the flow direction is in line with the flow direction arrows inside the pump door. 4. Insert the BodyGuard administration set into the pump by placing the black key into the keyway making sure the protrusions face upwards. Close the pump door until the catch clicks. WARNING: Use aseptic technique. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components and use single use consumables marked once only.

WARNING: Do not attach the set to the patient’s access device before priming the administration set.

WARNING: The key can only be fitted into the keyway one way. If you are having trouble fitting it do not force it in. Check to ensure you have correctly lined up the tubing with the direction of flow.

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7.3 POWERING UP AND PRIMING A SET WARNING: Do not attach the set to the patient’s access device before priming the administration set. 1. Once the set is loaded turn on the BodyGuard pump by pressing ON/OFF 2. During power up these screens display automatically to confirm pump software version and pre-set limits

BodyGuard XXXXX

Limit OFF Air Alarm 0.5 ml Occlusion XX psi

3. Press START/OK to resume a previous infusion (retain patient history) or Press OK to Resume Press NO for Menu

Press STOP/NO to take you to the main menu

4. Enter Level One access code, press START/OK

Level One Code ... Enter and Press OK

5 Ensure the cursor is pointing to ”Prime”, or scroll to if necessary (the text appears in a larger font), press START/OK

Prime Select Protocol Change Bag

6. The screen prompts you to check and ensure the pump is disconnected from the patient, to commence priming press START/OK

WARNING !! Disconnect Patient Press OK to Prime

7. The chart now displays the progress versus total pre-set priming volume. You may stop priming at any time or repeat the last two steps if the line is not completely primed after first priming function.

PRIME

8. On completion of priming the screen displays the main menu

=>Select Protocol

0 6 Prime Change Bag

NOTE: Priming volume is user configurable depending on the capacity of the administration sets in regular use in your service. For pain management sets, a 6ml prime volume is suggested. NOTE: All BodyGuard administration sets contain a check valve which means the line cannot be primed using gravity. Sets must be primed using the infusion pumps priming function. NOTE: The priming volume and rate can be changed in via the “Change Set Up” option in the main menu. Increasing the priming rate may cause excessive turbulence in the set on priming and make it difficult to purge all air from the system. CME Medical recommend a priming rate of <425ml/h.

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7.4 SELECTING A PROTOCOL 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. For example, in pain management it is common for patients to be on a regime consisting of bolus only delivery of a set concentration supplied by pharmacy in a fixed infusion bag volume. 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, using the Level Three access code in ‘Modify Protocol’ as described in the previous section, Level One code users can then 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. To select a protocol for a new patient: 1. Load an administration set, close the pump door and turn the power on (refer to page 18 “Powering up and priming” for full instructions) following completion of priming, the pump returns to the main menu. 2. Ensure the curser points to “Select Protocol”, (larger font denotes the option selected), press START/OK

Prime

=> Select Protocol Change Bag

3. To confirm set up is for a new patient, press START/OK To resume press STOP/NO (this carries forward patient totals)

New Patient? Answer OK or NO

4. Select the Protocol required by using ↑/↓ (larger font denotes the option selected), press START/OK

A: BOLUS

5. The infusion summary screens displays, to confirm press START/OK

VTBI Initial 480 ml VTBI Current 480 ml Volume Infused 0 Press OK to Continue

6. The protocol summary screen displays, to confirm press START/OK Review the summary screen carefully to ensure the parameters match the prescription

Rate 0ml/h Max. Rate 0ml/h PCA 1ml/ 5min OH Limit OFF

7. Start the infusion when ready to do so by pressing START/OK

8. The infusion summary screen now displays (See over the page for interpretation of this screen)

B: CONT + BOLUS C: D:

Start Infusion? P BOLUS

Bolus 1ml A Lock Out 5 min

NOTE: If MediGuard feature is turned on the user is prompted for patients weight. Enter in kilograms then press START. Refer to Appendices for MediGuard set up. CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.5 INTERPRETING THE SCREEN WHILST INFUSING 1 2 3 6

4

P BOLUS

Bolus 1ml A Lock Out 5 min

5 air

7

1.

“P”= Protocol.

2.

The title assigned to the protocol selected.

3.

The currently selected protocol letter displays in the left hand margin of the display.

4.

Programmed infusion rate (mg or ml/hour) - displays the current infusion rate in the units configured for that protocol, (i.e. ml/h, mg/h or mcg/h). If the maximum basal rate has been set to 0ml/h in ‘Change Set Up’, or the protocol does not contain a continuous infusion element, the infusion rate line will be replaced with bolus volume.

5.

Battery Status indicator-the battery symbol will be visible if the pump is not connected to the mains charger and the level of charge can be checked by monitoring the black fill inside the symbol (i.e. A completely black symbol indicates a fully charged battery).

6.

Displays the bolus volume for the current protocol. As with infusion rate this will be displayed in mls, mgs or mcg depending on how the current protocol is set up. If the maximum basal rate has been set to 0ml/h in ‘Change Set Up’ then this line is replaced with the bolus lock out time in minutes.

7.

Air detector indicator: if the single bubble air detection has been disabled then the display will indicate this with the word “air” (scored through) to warn the user. NOTE: Users can also confirm the pump is infusing by checking the LED is blinking green. The LED can be

7.6 RATE CHANGE DURING DELIVERY (Rate Titration) If the protocol selected contains an initial infusion rate and a maximal rate that allows titration then this rate can be titrated as follows: (example shown is changing rate to 2ml/h)

Rate 1 ml/h

1. Whilst the infusion is running, enter the new infusion rate using the numerical keypad, press START/OK (change not available if keypad Enter and Press locked) NOTE: If the rate selected is above the protocol maximum range the pump will not accept the entry and will display a message notifying the maximum rate allowed. Level One Code ...

2. Enter the relevant access code, press START/OK

Enter and Press OK

3. The pump beeps to confirm acceptance of the change and the new rate is confirmed on the display

P CONT + BOLUS

Rate 2 ml

B CME Medical BodyGuard ™ 595 Regional Analgesia Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.7 BOLUS DOSE DELIVERY The BodyGuard pump can be configured to deliver a patient-controlled bolus or an auto-bolus. In addition there is the option of a Clinician Activated Bolus. BodyGuard has a feature which optimises bolus delivery speed and prevents false occlusion alarms when infusing through narrow catheters. 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 catheters. NOTE: BodyGuard is capable of delivering the bolus dose up to a maximum rate of 1000ml/h and down to a minimum of 100ml/h in ‘Change Set Up’ Mode. The default setting is 300ml/h. A Level Three access code user can adjust bolus delivery rate as required. NOTE: Patient-controlled bolus and Clinician Activated Bolus will be covered in the following sections. For information on auto-bolus refer to Appendices, page 42.

PATIENT CONTROLLED BOLUS The BodyGuard pump can be programmed to allow the patient to administer bolus doses of medication on demand, either with or without a continuous background (basal) infusion. A patient-controlled bolus can only be activated via the remote bolus button. If a bolus has been programmed into the current regime 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 bar chart 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 chart is displayed and the pump continues with the back ground Infusion (if programmed). Users can check the time until the next bolus dose will be available for the patient by using the INFO key to view the Bolus Summary screen where the countdown is shown beside the boluses given count. Every minute, the infusion running screen will display when the next bolus is available. If an occlusion is experienced or the pump is stopped during bolus administration the pump will allow the remainder of the partially delivered bolus dose to be requested and delivered, once the occlusion has been cleared and/or the pump restarted, without the patient having to wait another full lockout period. If the patient does not take the residual within the lockout time the amount available resets to the programmed dose. NOTE: Every press of the bolus button, whether a dose is given or just attempted, enters a record in the patient history and 512 event log. Using the information key (see next section). It allows the user to check boluses given vs. attempts in order to check patient’s current regime is sufficient for their pain status.

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CLINICIAN ACTIVATED (CA) BOLUS During certain pain management protocols it may be necessary for the clinician to administer loading or top up bolus outside of the parameters of the standard protocol. A Clinician Activated Bolus can be given prior to, or during an infusion. A loading dose delivered before the user goes to ‘Select Protocol’, using the Clinician Bolus’ option from the main menu, will not show in the patient history as all counters are cleared when you select ‘New Patient?’ during protocol selection. If you wish the loading dose to be recorded then deliver it immediately after the infusion has commenced using the steps described over the page. CA boluses delivered after the start of a protocol are recorded in the current patient history and the number of doses and total volume can be seen on the Bolus Summary screen. WARNING: CA Bolus overrides programme limits. Take care to ensure only trained, authorised personnel have the relevant code and understand the function of this feature. NOTE: Lead personnel can limit the maximum clinician dose under ‘Change Set Up’ to prevent accidental overdosing. Default setting is 0ml for a single dose but this can be configured between 0ml (disabled) to 20ml (maximum). NOTE: If an occlusion occurs or the pump is stopped during clinician bolus delivery the user will have to repeat steps to deliver the balance of the CA bolus.

TO ADMINISTER A CLINICIAN ACTIVATED BOLUS/LOADING DOSE BEFORE THERAPY COMMENCES (i.e. immediately after the set has been primed and connected to the patient but before selecting a protocol): 1. Scroll down the main menu to ‘Clinician Bolus’, press START/OK

2. Enter the relevant access code (if authorised), press START/OK

3. Enter the desired volume of the bolus required, press START/OK 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. 4. To commence bolus delivery, press START/OK Bolus delivery status displays: On completion of bolus delivery the screen reverts to the main menu

Volume 2 ml

0

1.3

2

5. In the main menu, scroll to Select Protocol and proceed with set up

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TO ADMINISTER A CLINICIAN ACTIVATED BOLUS DURING AN INFUSION: 1. To stop infusion delivery, press STOP/NO

2. Press the bolus key (syringe icon)

3. Enter Clinician access code, press START/OK

4. Enter the desired volume of the bolus required, press START/OK 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. Volume 2 ml Bolus delivery status displays: 0

1.3

2

Once BodyGuard has delivered the CA Bolus the infusion continues running the current protocol.

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