BodyGuard 545 Operation Manual Rev 2.3 Oct 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™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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1.0 BODYGUARD PUMP OVERVIEW The BodyGuard™ 545 Epidural Infusion Pump provides the following

 Multiple programmes

- Bolus only (Patient Controlled (PCEA)) - Continuous (basal) plus patient controlled bolus - Continuous only epidural 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 an epidural catheter 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™ communication software (optional)

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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2.0 PUMP DESCRIPTION AND FUNCTIONS FRONT OF BODYGUARD PUMP

10

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™ 545 Epidural 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 and then 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 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™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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BODYGUARD PUMP WITH DOOR OPEN 1 8

2

6

3

7

4 5

No.

Area

Function

1

Door latch

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

2

Pressure sensor (behind keyway)

Detects downstream tubing restriction and occlusion alarm level adjustable to suit patient/infusion type

3

Keyway

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

4

Pressing plate

Connected to the door by two springs

5

Pump door

Covers the pressing plate

6

Air sensor - front

Ultrasonic air detector mounted on the front housing

7

Air sensor- door

Mounted on the door

8

Flow direction

Shows direction of fluid flow

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™ 545 Epidural 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™ 545 Epidural 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

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 Serial number

Expiry date of disposable

LOT STERILE

Lot number

EO

Sterilised with Ethylene Oxide

CME Medical BodyGuard™ 545 Epidural 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™ 545 Epidural Infusion Pump is intended to be used only for administration via the epidural or intrathecal route (collectively referred to as neuraxial). BodyGuard™ pump fully complies with the recommendations of the NHS National Patient Safety Agency (NPSA) that colour-coded epidural administration sets and dedicated epidural pumps should be used for application via this route so as to clearly distinguish them from equipment used for delivery via other routes (e.g. I.V.). To minimise risk when administering neuraxial infusions the BodyGuard™ 545 Epidural Infusion Pump and the dedicated administration sets are yellow colour-coded to clearly denote the intended route of 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: Drugs must not be administered to the epidural space unless the drugs are indicated for this purpose and are administered in accordance with the indications included in the manufacture’s package. Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. For epidural administration of drugs use the BodyGuard dedicated micro set only.

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 545 Epidural 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 545 Epidural 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™ 545 Epidural 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 epidural 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™ 545 Epidural 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™ 545 Epidural 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 for a patient.  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™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.0 OPERATING THE BODYGUARD PUMP 7.1 SECURITY Before performing any of the set-up and period tests or to operate, programme or configure the pump you will need to access the pump using the security codes. As the BodyGuard pump is designed for pain management therapies the pump has several levels of security to ensure safe set up and administration of pain protocols and to prevent idle or malicious tampering.

ACCESS CODES To operate, programme and configure the BodyGuard pump three access codes are required. Level One

700

Allows user to run pre-set protocols and titrate infusion rate (within pre-set protocol 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 in ‘Change Set Up’ * / ** refer to senior clinical or lead service personnel for relevant code A further code is used to access the technicians menu but this is only provided to fully trained (by CME Medical) and authorised Electro-Biomedical Engineering departments. Changes of pump set up and configuration are changed via the BodyComm™ communications software. Code numerals can be changed and the code level applied to certain functions can be changed if required. KEYPAD LOCK As a further, simple security feature you can also lock the keypad. 1. Whilst the pump is infusing press and hold displays goes from OFF to ON

until the Lock Mode chart which the pump

2. This now prevents the operation of all keys except 3. To unlock the keypad press and hold

and

again until the chart goes from ON to OFF

NOTE: To prevent unauthorised individuals accessing the main menu a technique is required to return to the menu code screen when the pump is in STOP mode. To return to the menu during infusion: press STOP (to stop delivery and enter the STOP state). Press and hold STOP until the ‘Resume or Menu’ choice prompt appears. NOTE: When keypad lock is on, entering the stop state and holding down STOP will not return you to the main menu. Press START (to restart the infusion), press and hold INFO (to remove keypad lock), then press and hold STOP until prompted for the access code to return to the main menu.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.2 SETTING UP AND MODIFYING PROTOCOLS When you receive your BodyGuard pump and go to ‘Modify Protocol’ on the main menu for the first time you will see that all protocols are blank. You can edit, add or delete up to a maximum of 26 infusion protocols to tailor the protocols to your service (CME Medical can pre-programme if requested). From the main menu you access “Review Set up” and “Change set-up” to view and set local preferences for device configuration from the options available. Some initial settings may need to be activated from the Technicians menu or BodyComm™ communications software. This section is probably the most complex of the manual but remember you should only have to perform this function once for each protocol with each pump whilst you are setting it up for use on the first few patients. You may also ask CME Medical representatives or service personnel to assist with the set up of the pump which can be done prior to delivery.

Each protocol requires the following data (depending on initial set up): A. Drug/Protocol name (up to 18 characters) B. Volume to be infused (VTBI) C. Initial infusion rate in ml, mg or mcg per hour. This step and the protocol maximum rate step will be hidden if the pump has been set to 0ml maximum basal rate by the technical staff. D. Protocol Maximum rate (to allow titration within protocol) E. Bolus volume (if applicable) F. Maximum bolus G. Lock Out between boluses (if applicable) Drug concentration (optional) H. Programme Limits: MediGuard and volume/bolus limit (choice of 0, 1, 4 or 24h limit of either volume boluses set up) Set under “Change Set Up” as applicable. NOTE: You can use protocols to set up several commonly used treatment regimes in your service i.e. same bag, drug name, basal rate but different bolus volumes or lockout times. NOTE: Each protocols parameters are unique to that protocol. For example if you use both Ropivacaine and Bupivacaine in your service and one commonly comes in a 100ml bag whilst the other is in a 250ml bag then you can set these bag sizes as standard for each. NOTE: After setting up your most common regimes as a protocol set up the next or last protocol letter as a ‘Tailored’ or one off regime that you can modify for individual patients who don’t fall within the pre-set protocols. Once the infusion has been administered for a particular patient you can go back in and change this for the next or a future patient. NOTE: Entry of all parameters is via the numeric keypad. Only the protocol selection is a scroll option menu using the UP and DOWN arrows. The previous value will be displayed. Enter the new value, which will automatically delete the previous value. If you make an error whilst entering, pressing STOP will delete the previous digit. Repeat as necessary. NOTE: At certain screens, if you delay for a period of time between key presses the pump will revert to the previous screen. CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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PROGRAMMING DRUG/REGIME PROTOCOLS NOTE: The BodyGuard pump has a system called MediGuard which can be activated under ‘Change Set Up’, Program Limits’. When this feature is set to ‘ON’ the pump will ask for the patients weight at the stage of entering the protocol. If disabled you will skip this stage. Refer to Appendices for instructions for setting up protocols with MediGuard enabled.

1. From the main menu select “Modify Protocol” and press

E Change Bag P =>Modify Protocol Event Log I

2. Enter Access Code and press

E Level Three Code P ... I Enter and Press OK

3. Scroll to select the protocol for adding/modifying, (A to Z) press If setting up protocols for the first time, the protocol initial only will be visible.

A: B: C: D:

A. DRUG/PROTOCOL NAME P

Protocol A 4. To enter the edit mode and add a protocol name press If you need to delete a protocol name previously entered press A continuously until the cursor is at the left side of the display. Even if the name appears empty you must still perform this step as the line is full of blank spaces. 5. Use numeric keys 2 (up), 4 (left), 6 (right) and 0 (down) as cursor keys to navigate around the letter, number and symbol choices. To select a character, position the white cursor over the target letter/number/symbol, press Repeat the last step as required to build your protocol name. To add a space, position the cursor in the top left blank space of the grid and press The maximum name size is 18 letters/digits including spaces. 6. When you have finished building your protocol name position the cursor in the top right side, press

to confirm your new Protocol name:

P A

Then either:

7. Press

to accept your new name and return to protocol selection or

8. Press

to return to edit mode

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

Protocol A Bupiv + Fent

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9. By returning to edit the protocol list (A to Z) displays:

A: Bupiv + Fent B: C: D:

Select the protocol to edit, press

B. VTBI 10. Enter bag volume in ml, press To change any numeric programme parameter just enter the numbers which will replace the previous value and this will overwrite the previous value.

11. If you make a mistake whilst entering, press Press

to delete the last digit entered

when correct value is entered

C. INITIAL INFUSION RATE (ml/h) 12. Enter the initial rate using the numeric keypad, press If the rate step does not appear then the Maximal Rate under ‘Change Set Up’ has been set to 0ml/h to prevent users from delivering regimes with a continuous element. If you have the authority to change this go to ‘Change Set Up’ (see later section).

D. PROTOCOL MAXIMUM RATE 13. This will have defaulted to the initial rate you have just set. Enter the maximum rate you will allow for this protocol, press For example, you may wish to start an epidural with 6ml/h but allow users to titrate up to12ml/h.

NOTE: To programme in mg/h or mcg/h: Press STOP 4 times respectively (first press clears the previous rate, second asks if you want to accept “ml only” and third takes you to concentration mg/ml screen. A further press takes you to mcg/ml). To specify the concentration in mg or mcg/ml of the drug regime you are programming, use the numeric keypad to enter the value (i.e. 1mg/ml). Press START/OK when done. NOTE: BodyGuard pump is capable of continuous (basal) rates of up to 30ml/h. Users can fix a maximum basal rate in ‘Change Set Up’ using the Level Three access code to ensure other users cannot accidentally programme the pump to deliver above the safe ceiling for your commonly used drugs.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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E. BOLUS VOLUME (if applicable)

14. Change or accept the bolus volume using the numeric keypad, press

F. MAXIMUM BOLUS 15. Enter the maximum bolus, press

G. LOCK OUT BETWEEN BOLUSES

16. Change or accept the Lock Out (bolus lockout interval) in minutes, press

H. PROGRAMME LIMITS NOTE: If the screen does not appear, then the option is set to off in "Change set up" (zero hour limit is the default).

17. Change or accept the 0, 1, 4 or 24 hour limit. To turn the limit off enter ‘0’, press Depending on how this has been configured under ‘Change Set Up’ in ‘Programme Limits’ the pump will ask you to set the limit in either volume (ml), concentration (mg or mcg) or number of boluses. If MediGuard is enabled, refer to Appendices for MediGuard Set Up.

18. You can now confirm or review the settings entered: If satisfied with protocol settings, press This will return you to the main menu screen, “Select Protocol”

Confirm: Press OK Review: Press NO

If you wish to review or change your settings, press This will return you to the Protocol list (A to Z) selection screen to continuously run through and check/change your entries before arriving back at the ‘Confirm’ or ‘Review’ screen. WARNING: Before the pump is put into use check the defaults (by selecting ‘Review Set Up’ from the main menu) are appropriate for your intended use. Settings can be changed in ‘Change Set Up’ using the relevant code. CME Medical recommend this is done only by the lead clinical person or your local electronic engineering department. Please see the later section on ‘Change Set Up’ for further information. CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.3 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 (yellow-epidural) 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 (yellow), epidural 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 epidural 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 agents such as morphine. 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™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.4 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 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.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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7.5 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

2. During power up these screens display automatically to confirm pump software version and pre-set limits

3. Press Press

BodyGuard XXXXX

to resume a previous infusion (retain patient history) or to take you to the main menu

4. Enter Level One access code, press

5 Ensure the cursor is pointing to ”Prime”, or scroll to if necessary (the

Limit OFF Air Alarm 0.5 ml Occlusion XX psi E Press OK to Resume P Press NO for Menu I E Level Three Code P ... I Enter and Press OK

E =>Prime P Select Protocol Change Bag I

text appears in a larger font), press

6. The screen prompts you to check and ensure the pump is disconnected

WARNING !! Disconnect Patient Press OK to Prime

from the patient, to commence priming press

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.

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

0 (Press NO to Stop)

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E Prime P =>Select Protocol Change Bag I

NOTE: Priming volume is user configurable depending on the capacity of the administration sets in regular use in your service. For epidural 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. CME Medical BodyGuard™ 545 Epidural Infusion Pump Operation Manual/Rev 2.3/October 2013

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