BodyGuard 545 Color Vision Quick Reference Guide Rev 00

Infusion Setup STEP 1

BodyGuard 545 Color Vision Epidural

Pump Serial Number: V123456 Production Date: 1-Jan-2000 Software Version BGCV545_02B

• Ensure the pump is secured in the pump charger. Ensure the pump and charger are fastened to the pole (if using pole) using the roller wheel at the back of pump charger. • Switch on the pump by pressing screen appears for few seconds.

. Start-up

• Plug the bolus cable into the side of the pump labeled “Bolus”. Refer to the BodyGuard 545 Color Vision Directions for Use for more information on how to use the bolus cable.

Protocol Sample

• If applicable, Protocol (drug library) is displayed at bottom of screen. Verify it is correct. Contact a clinical supervisor or biomed engineer, if needed.

STEP 2

• Different operations may require a code. Enter the code and press

Level One Code

• Consult your clinical supervisor as necessary.

**********

Enter and Press

.

Key

• A lockbox may be used to lock the device/ medication. Ensure that the key is secured by authorized personnel.

For safety reasons, security codes should only be given to the appropriate personnel.

STEP 3

2

1

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• Ensure the appropriate infusion set has been selected. Only use dedicated BodyGuard sets. • Check that the sterilized infusion set package is not damaged. • Follow the instructions supplied with the infusion set. • If door is difficult to close, open door fully to verify correct loading of infusion set. • Left figure - 1: black key; 2: blue ring (anti-stretch locator).

Loading Infusion Set STEP 4

• Insert the bag spike into the fluid container. • If a drip chamber is present, fill the drip chamber halfway.

A drip chamber may not be part of the set. Use the available spike to pierce the reservoir.

STEP 5

• Pull down the door latch to open the door. • Securely fit the black key into the pressure sensor fitment on the right side. • Locate the black key into the pressure sensor. • The two protrusions must face up. The key can only be loaded in this direction. • Ensure that the flow direction is in line with the flow direction arrows inside the pump. The arrows indicate the direction to the patient.

STEP 6

• Locate the blue ring (anti-stretch locator) in the left side of the tubing channel around the air sensors. • Close the door fully until a click is heard.

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Infusion Set Priming STEP 1 EPIDURAL

• To prime and eliminate the air from the set, select the automatic prime function on the main menu. 10:00

Prime

-

70%

█■

Select Protocol Change Bag View Protocol Settings View Shift Totals View Patient History View Event Log Clinician Bolus

Select

,

and press

• Ensure that the patient is disconnected prior to starting the prime function.

STEP 2 EPIDURAL

10:00

-

70%

█■

Warning !

• Follow the instructions on the screen to proceed.

Disconnect Patient Press

key to Prime

The prime function must not be performed while the set is connected to the patient. Infusion of air can lead to air embolism which may result in serious injury or death. Prime function must be performed before any change in infusion.

STEP 3 EPIDURAL

• The screen displays the priming progress. 10:00

-

70%

Priming ██████████████ 1 5mL (Press

█■

• On completion, the screen will return to the main menu. • You can stop priming by pressing the

key to Stop)

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key.

Start New Infusion STEP 1 EPIDURAL

10:00

Prime

-

70%

█■

• Press

Select Protocol

Change Bag View Protocol Settings View Shift Totals View Patient History View Event Log

Press

- Exit Menu

Select

,

• Follow the instructions on the screen to proceed.

and press

• For a new patient, enter a numeric patient ID

EPIDURAL

10:00

-

70%

█■

. If you do not have

• For an existing patient, press

Patient ID:

.

.

• The ID number will be stored in the pump’s event log.

or

STEP 3

• Select the appropriate drug. In case of doubt, contact a clinical supervisor or biomed engineer.

EPIDURAL 10:00 A: Levobupivacaine

-

B: Bupivacaine

,

number and press

a patient ID, skip that step and press

New Patient?

Select

to select Select Protocol.

• Enter the level one access code.

STEP 2

Answer

• From the main menu, scroll to Select Protocol using the arrow keys.

70%

█■

. .

and press

If no drug is available, return to the main menu and select “Modify Protocols”. In order to add and edit the drug library, consult a clinical supervisor.

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Start New Infusion STEP 4 EPIDURAL

• Enter patient weight in kg and confirm. 10:00

A: Levobupivacaine

-

70%

█■

Patient weight

• Weight must be within the protocol limits.

55 kg Enter and Press

• Re-enter if necessary and confirm. Key

STEP 5 EPIDURAL

• Wait until flashing is complete before moving to the next step.

10:00

A: Levobupivacaine

-

70%

█■

• Optional: auto-bolus alert is displayed only when this function is enabled.

Warning ! Patient will Periodically receive an automatic bolus. Press

to Confirm

STEP 6

• On the Summary screen, review the infusion parameters and confirm.

A: Levobupivacaine

Bag Volume Vol. Remaining Rate Patient Bolus Lockout Time Protocol Limit Patient Weight

to Confirm or

10 mL 10 mL 2ml/hr 3 ml 15min Off 60 kg

• To make changes, press the

to Change

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key.

Start New Infusion STEP 7 EPIDURAL

• Press 10:00

-

70%

█■

key to begin your infusion.

• If this is not confirmed, pump will alert after 2 minutes.

Start Infusion ? Press key to start for Loading Dose & Start

To stop the infusion at any time: • Press the key, recommended action. Or, • Close the roller clamp and then open the door.

STEP 8 EPIDURAL

10:00

-

70%

█■

Start Auto-Bolus? Press

key to start

Press

to Delay Auto-Bolus

for Loading Dose & Start

• Optional: if auto-bolus is enabled, choose whether to start with auto-bolus or to delay auto-bolus and begin the infusion program. • Press the key to begin with a loading dose (clinician bolus). • Loading Dose is optional. To bypass Loading Dose, press Start. To initiate Loading Dose, press

.

Infusion Screen Protocol & Protocol Letter

EPIDURAL

A: Levobupivacaine air

Basal Rate (ml/hr or mg/ml) Patient bolus volume )When applicable( Auto bolus volume )When applicable(

Rate:

2

10:00

-

70%

█■

mL/hr

Patient Bolus Dose Lockout Time Auto-Bolus Dose Auto-Bolus interval

10 mL 30 Minutes 2 mL 15 Minutes

██████ █████████ ████████ █

█

110 of 350 mmHg

Title bar - type of treatment, time, battery status indicator

Time between two patient boluses (When applicable) Time between two auto boluses (When applicable) Actual Pressure Bar

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Clinician Bolus Delivery STEP 1

To deliver a clinician bolus during infusion:

EPIDURAL

10:00

-

70%

Clinician Bolus Dose

5 mL

(Maximum

Press

█■

• Press the

key

• Press the

key.

• Enter the level two code and press

.

• Enter the clinician bolus dose within the protocol limits.

20mL)

Key to Start

Clinician Bolus may be disabled in the protocol.

STEP 2 EPIDURAL

• Bolus progress is displayed on the screen.

Bolusing

10:00

-

70%

█■

• You may stop the bolus at any time.

███████████████████

Bolus Dose

5 mL

Bolus Rate

2 mL/hr

████████████████████████

20 of 400 mmHg

If the VTBI is reached during a bolus, an End of Infusion alarm will sound.

STEP 3 EPIDURAL

• If a bolus is stopped, the remainder will be available. 10:00

-

70%

Pump Stopped

███████████████████ 2 min

Bolus Interrupted

0.078 mL of 20 mL Delivered Patient Bolus available in 1 Minutes

█■

• Select whether to resume the bolus infusion or return to the main infusion. • Follow the onscreen instructions.

to Deliver Remaining Bolus to Cancel Remaining Bolus

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Rate Titration, Keypad Lock, Resume/Repeat Rate Titration EPIDURAL

10:00

-

A: Levobupivacaine air

Rate:

70%

To change rate during infusion: █■

• Enter level one code and press

2 mL/hr

Patient Bolus Dose 10 mL Lockout Time 30 Minutes Auto-Bolus Dose 2 mL Auto-Bolus interval 15 Minutes ████████ ████████████ ██████████ 110 of 350 mmHg █

key. .

• Single alarm sounds as confirmation. • Make sure the new rate is displayed on the screen.

█

Keypad Lock EPIDURAL

• Enter a new rate and confirm with

10:00

Keypad Lock Mode

-

Keypad lock prevents unauthorized changes: 70%

█■

• Press and hold the keypad.

key to lock or unlock the

• During lock mode you may:

████████████████ Off On

◊ Stop/start the infusion ◊ Mute an alarm/alert ◊ Switch off the pump

Resume/Repeat Continuous

Resume – Press Repeat – Press

10:00

-

80% ███■

• Pump was switched off before the last infusion has ended. ◊ Select Resume to continue from the last stopped position. ◊ Select Repeat to start a new infusion.

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Change Bag STEP 1 EPIDURAL

At end of an infusion: 10:00

-

70%

█■

End of Infusion

• Follow the instructions on the screen to proceed.

Key to Menu

STEP 2 EPIDURAL Prime Select Protocol

If a bag change is required at end of an infusion: 10:00

-

70%

█■

Change Bag

View Protocol Settings View Shift Totals View Patient History View Event Log Clinician Bolus

Select

,

• An alarm sounds. • If applicable, a KVO rate will start automatically unless interrupted.

Keep Vein Open Rate 2.5 mL/hr Press

• The infusion stops.

• Select the feature from the menu. • Continue to next screen. If a bag change is required prior to end of an infusion:

and press

• Press EPIDURAL

10:00

-

Change Bag Press

70%

█■

to record the VTBI / VI.

• Stop the infusion. • Go to menu and select Change Bag – follow instructions on screen.

when done

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Alarms Low Battery EPIDURAL

10:00

• Approximately 30 minutes of battery operation remaining. -

20% ██■

• Verify that a power supply is accessible.

Low Battery Connect to Charger

End of Infusion EPIDURAL

10:00

-

70%

• The infusion has ended. The screen may show a KVO rate if it was set up. █■

End of Infusion Keep Vein Open Rate 2.5 mL/hr Press

Key to Menu

Near End EPIDURAL

10:00

• Bag/infusion nearly finished. Prepare new bag if applicable. -

70%

█■

Near End

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Alarms End Battery EPIDURAL

10:00

-

2%███■

• Battery depleted. Connect to mains or replace the battery immediately.

End Battery Connect to Charger

Pump Paused Too Long EPIDURAL

10:00

-

70%

█■

70%

█■

Pump Paused Too Long Press

• If the pump is turned off, you will have the option to resume from the last position.

key

Missing Key EPIDURAL

• Pump “Stopped” or unattended for 2 minutes or more. Resume infusion or turn off the pump.

10:00

-

• The set is loaded incorrectly or a non-proprietary set has been loaded. Reload set according to the infusion set directions for use.

Missing Set Key Load Set Key & Close Door Press key to mute

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Alarms Door Open EPIDURAL

10:00

• The pump door has opened during infusion. Check set, close door, and resume infusion. -

70%

█■

Door Open Close door

Error EPIDURAL

10:00

-

70%

█■

• A system error occurred. Follow instructions on the screen. If error persists, contact service personnel.

Restart Pump Switch off & on ERROR XX

Air/Up Occlusion EPIDURAL

10:00

-

70%

█■

• Air in the set or occlusion above the pump. Disconnect patient and prime the air out of set. Check for occlusion.

Air/Up Occlusion Check for air / occlusion Press

key to mute

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Alarms Down Occlusion EPIDURAL

10:00

Down Occlusion Check Set / Access Press

key to mute

-

70%

█■

• Patient side occlusion occurred. Auto resume feature monitoring back-pressure to determine if infusion can continue. ◊ Press

to mute

◊ Clear occlusion in the set or infusion site - check catheter for occlussion or for closed clamps ◊ Press

key to resume infusion

Despite the benefits provided by early detection of occlusions and reduced time to alarm, the pump is not designed to provide protection or detection of extravasation nor infiltration, therefore, the clinician must also check the infusion site on a regular basis and follow hospital protocols when infusion complications occur.

When an alarm activates: • Infusion stops. • Infusion status indicator illuminates flashing red, flashing yellow, or solid yellow. • Alarm sound continuously until either pump is paused or problem rectified. • Always note the condition before stopping the pump.

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Cleaning & Maintenance Before connecting the pump to a patient, and periodically during use, clean the unit as instructed below.

• Always turn the pump off and remove the battery before cleaning. • Always unplug the charger from AC power before cleaning. • Do not clean the pump or charger with chemicals such as Xylene, Acetone, or similar solvents. These chemicals can cause damage to plastic components and paint. Use a lintfree cloth with hydrogen peroxide 10% or isopropyl alcohol 70%. • Do not steam autoclave, ethylene oxide sterilize or immerse any part of the pump or charger in any fluid

Periodic maintenance is recommended every 1 year. Periodic maintenance is designed to ensure the pump’s accuracy and detect and repair any potential pump inconsistencies prior to their occurrence in the field. Refer to the directions for use for information about periodic maintenance. There is no additional time required for the unit to equilibrate once removed from minimum to maximum storage temperatures. Ensure to operate the pump within the specified operating range. The expected service life of the pump and charger is 3 years. The rating of the pump is IP33. This is the moisture protection rating and indicates the degree of particle and water ingress protection.

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Intended Use The BodyGuard 545 Color Vision™ infusion pump system is designed for patients who require epidural pain management, requiring continuous and/ or intermittent (bolus) delivery at precisely-controlled infusion rates through clinically acceptable routes of administration such as epidural and intrathecal routes. The BodyGuard 545 Color Vision™ infusion system is for use by, or under the supervision of trained medical staff in the hospital or home care environments. • Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterizing equipment. False alarms may occur. • Do not operate pump in an MRI environment or in the presence of strong magnetic field. Serious injury or damage to the pump may occur.

Ambulance Use Pumps may be used in road ambulances by paramedics and ambulance emergency medical technicians. Pumps must be 30 cm away from other devices that may create Radio Frequency Interference.

Hazards Potential strangulation may occur if cables/tubing are of excessive length. Potential choking may occur if small parts are inhaled or swallowed. Potential allergic reactions may occur due to materials used in the pump. Children, pets, fireplaces, dust, lint, direct sunlight all may affect the pump operation.

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Place Contact Information Here

BodyGuard 545 Color Vision™ is a registered trademark of Caesarea Medical Electronics Ltd. or one of its subsidiaries.

Caesarea Medical Electronics Ltd. 16 Shacham Street, Industrial Park Caesarea North, P.O.BOX 3009 Caesarea 3088900, Israel www.cme-infusion.com

MedNet GmbH Brokstrasse 10 48163 Muenster, Germany +49 251 32266 0