CME BodyGuard 545 Color Vision Directions For Use Manual
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CME BodyGuard 545 Color Vision Directions For Use Manual

Epidural infusion system
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BodyGuard 545
Color Vision
Epidural Infusion System
Directions For Use
Caesarea Medical Electronics Ltd.
16 Shacham Street
Industrial Park Caesarea North
P.O.Box 3009
Caesarea 3088900, Israel
www.cme-infusion.com
W:
™
0344
MedNet GmbH.
Borkstrasse 10
48163 Muenster
Germany
T: +49 251 32266 0
Ref.: DFU999-683EN Rev.00

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  • Page 1 ™ Epidural Infusion System Directions For Use 0344 Caesarea Medical Electronics Ltd. MedNet GmbH. 16 Shacham Street Borkstrasse 10 Industrial Park Caesarea North 48163 Muenster P.O.Box 3009 Germany Caesarea 3088900, Israel T: +49 251 32266 0 www.cme-infusion.com Ref.: DFU999-683EN Rev.00...
  • Page 2 BodyGuard 545 Color Vision™ Directions For Use...
  • Page 3 BodyGuard 545 Color Vision™ Directions For Use...
  • Page 4 BodyGuard 545 Color Vision™ Directions For Use...

  • Page 5: Table Of Contents

    Table of Contents 1- Introduction Overview Keypad Features BodyGuard 545 Color Vision™ Pump with Open Door BodyGuard 545 Color Vision™ Charger System Safety Checks Pump Accuracy 2- Symbols, Warnings, and Cautions System Symbols Terms Used In Manual Intended Use Warnings Cautions 3 –...
  • Page 6 BodyGuard 545 Color Vision™ Directions For Use...

  • Page 7: 1- Introduction

     Rechargeable internal Lithium-Polymer battery  Battery charged in a pole mount charging cradle or with an A/C adaptor  Free flow protection valve as standard on all CME administration set  Quiet operation  Used for ambulatory care in a carrying pouch or mounted on an IV pole ...

  • Page 8: Keypad Features

    3. Lock Mode  Will lock keys to prevent settings changes.  Unlocks the pump.  Press continuously to lock/unlock the keypad to prevent accidental change to pump operation.  BodyGuard 545 Color Vision™ Directions For Use...
  • Page 9 Change bolus parameters during infusion.  Can be enabled/disabled under Change Set Up.  Activates clinician (CA) bolus when pump is in STOP mode. 10. Arrows  Scrolls up, down, right, and left through options. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 10: Bodyguard 545 Color Vision™ Pump With Open Door

    1 - Introduction BodyGuard 545 Color Vision™ Pump with Open Door Area Function Anti-Stretch locator Assists user correct loading administration set. Air sensor – Front Ultrasonic air detector, which is mounted on the front housing. Air sensor – Door Mounted on the door.

  • Page 11: Bodyguard 545 Color Vision™ Charger

    To disconnect from mains, remove the charger cord from mains. The plug is the main isolation device for the pump. Do not position the pump in such a way to make it difficult to disconnect from the mains. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 12: System Safety Checks

    Air-in-Line Detection To improve the detection of air in the IV line, the BodyGuard 545 Color Vision™ system utilizes an air-in-line accumulation system in addition to the standard single bubble detection. This feature monitors the volume of air that passes through the IV line by accumulating the volume of individual bubbles within a 15 minute period.

  • Page 13: Pump Accuracy

    They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed according to IEC 60601-2-24 standard. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 14 Short-term fluctuations in rate accuracy may have clinical impact depending on the shelf life of the drug being infused and the degree of inter-vascular integration. The clinical effect cannot be determined from the trumpet curves alone. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 15 1 - Introduction BodyGuard 545 Color Vision™ Directions For Use...

  • Page 16: 2- Symbols, Warnings, And Cautions

    2 – Symbols, Warnings and Cautions 2- Symbols, Warnings, and Cautions System Symbols The following symbols are used on the BodyGuard 545 Color Vision Infusion System and components. Labels on the system or statements in this manual proceeded by any of the following words and/or symbols are of special significance and are intended to help you to operate the pump in a safe and successful manner.
  • Page 17 Indicates the manufacturer’s catalogue number so that the medical device can be identified. Indicates a medical device that should not be used if the package has been damaged or open. Indicates the number of drops per milliliter. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 18: Terms Used In Manual

    Before operation, verify that the IV line is not kinked or occluded. The BodyGuard 545 Color Vision™ should be operated only with the MicroSet™ IV lines. Use of IV lines other than the MicroSet™ may impair the operation of the pump and the accuracy of an infusion.
  • Page 19 Any adjustments, maintenance, or repair of the uncovered pump or charger while connected to the power should be avoided. The BodyGuard 545 Color Vision™ infusion system should be operated within the recommended environmental operating range. Operating the pump at temperatures and/or humidity other than within that range may affect accuracy.

  • Page 20: Cautions

    Use a lint-free cloth with hydrogen peroxide 10% or isopropyl alcohol 70%. Immersing the BodyGuard 545 Color Vision™ infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid.

  • Page 21: Installation And Set Up

     External wall charger (optional) (cable length: 2.0 meters) NOTE: If any items are missing or damaged, contact your BodyGuard 545 Color  Vision™ supplier. NOTE: In certain locales, Power Cord may come as a separate item.  BodyGuard 545 Color Vision™ Directions For Use...

  • Page 22: Charging The Pump

    6 hours,. replace the battery. 4. Remove the pump from the charger by pressing the release button (located next to the LED indicators on the charger), Lift the pump out of the charger bottom first. Release Button BodyGuard 545 Color Vision™ Directions For Use...
  • Page 23 3 – Installation and Set Up Caution: Leaving the battery discharged for a long period of time may damage the battery. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 24: Operation

    Access Codes & Keypad Lock To operate, program and configure the BodyGuard 545 Color Vision Epidural Infusion pump three Access Codes are required.

  • Page 25: Dedicated Administration Sets

    Dedicated Administration Sets The BodyGuard 545 Color Vision Infusion System should be operated only with dedicated Infusion sets. MicroSet Warning: Do not operate the BodyGuard 545 Color Vision Infusion System with any administration set, other than the MicroSet . The MicroSet Infusion Sets are equipped with a free flow protection valve, to prevent a gravity free flow hazard.

  • Page 26: The Bodyvalve Tm

    Warning: Air embolization can cause death or serious injury to the patient. Do not connect a patient to the BodyGuard 545 Color Vision Infusion Pump until all trapped air has been cleared from the fluid path. Carefully read the instructions for loading.

  • Page 27: Straight-Line Epidural Microset

    NOTE: Follow the instructions supplied with the individual administration set.  Warning: Use of any administration set, other than the MicroSet , may impair the operation of the pump and the accuracy of the Infusion. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 28: Priming The Set

    545 Color Vision Color Vision Epidural Pump Serial Number: V123456 Production Date: 1-Jan-2000 Software Version BGCV545_02B Protocol Sample The screen than will prompt for level one code. Enter code 700 and press BodyGuard 545 Color Vision™ Directions For Use...
  • Page 29 NOTE: The priming volume is selectable depending on the capacity of the  administration sets in regular use in your service. NOTE: The priming volume can be changed in “Change Set Up” (see later  section). BodyGuard 545 Color Vision™ Directions For Use...

  • Page 30: Priming The Line

     Therefore, the line cannot be primed using gravity and must be primed either using the BodyGuard 545 Color Vision™ pump priming function or by pressing on the manual priming valve if one exists on the set. In case manual priming is required, use an administration set with special manual priming valve.
  • Page 31 View Shift Totals View Patient History pressing View Event Log Clinician Bolus View Set up Modify Protocol Library Change Set up Press - Exit Menu Select and press The pump will prompt for code. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 32 Even if the name appears ABCDEFGH1234+- empty you must still perform this step as the IJKLMNOPQ5678%& line is full of blank spaces. RSTUVWXYZ90.,:/ Abcdefghijklmno pqrstuvwxyz@() to Edit BodyGuard 545 Color Vision™ Directions For Use...
  • Page 33 15. Enter patient maximum weight for this EPIDURAL 10:00 █ ■ protocol. A: Levobupivacaine When MediGuard is Off you may set to 0 kg Maximum Patient weight (no maximum). Press to confirm. Enter and Press BodyGuard 545 Color Vision™ Directions For Use...
  • Page 34 30ml/hr. User can enter a maximum basal rate in "Change Set Up" using the level three access-code to ensure other users can not accidentally program the pump to deliver above the safe ceiling for your commonly used drugs. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 35 Auto Bolus ? Answer EPIDURAL 10:00 █ ■ A: Levobupivacaine Patient Bolus Combined with Auto-Bolus ? Answer NOTE: Auto bolus option can be enabled or disabled from the Technician  menu. See Auto Bolus section. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 36 10:00 █ ■ periodically receive an automatic bolus until A: Levobupivacaine the hour limit or VTBI have been reached. Warning ! Patient will Press key. Periodically receive an automatic bolus. Press to Confirm BodyGuard 545 Color Vision™ Directions For Use...
  • Page 37 A: Levobupivacaine an automatic bolus until the hour limit or VTBI Warning ! Patient will have been reached. Press key. Periodically receive an automatic bolus. Press to Confirm BodyGuard 545 Color Vision™ Directions For Use...
  • Page 38 Auto-Bolus interval Minutes Enter and Press 37. Set the lockout time from patient bolus and EPIDURAL 10:00 █ ■ A: Levobupivacaine auto bolus and press Patient Bolus To Auto-Bolus Minutes Enter and Press BodyGuard 545 Color Vision™ Directions For Use...
  • Page 39 A: Levobupivacaine Limits Setting 1 Hours 4 Hours 24 Hours Select and press 42. Enter volume per hour limit and press EPIDURAL 10:00 █ ■ A: Levobupivacaine 1 Hour Limit Enter and Press BodyGuard 545 Color Vision™ Directions For Use...
  • Page 40 OFF in the  Change Set Up menu this screen will not be Select and press displayed. EPIDURAL 10:00 █ ■ A: Levobupivacaine Max MediGuard Rate mg/kg/hr Enter and Press BodyGuard 545 Color Vision™ Directions For Use...

  • Page 41: Select Protocol (Start An Infusion)

    Confirm: Press Review: Press NOTE: BodyGuard 545 Color Vision™ is capable of delivering the bolus  dose at up to 1200 ml/hr. The user can adjust bolus delivery down to a minimum of 40 ml/hr in "Change set up mode" using the level three access code.
  • Page 42 EPIDURAL 10:00 █ ■ Prime the arrow keys and pressing Select Protocol Change Bag View Protocol Settings View Shift Totals View Patient History View Event Log Press - Exit Menu Select and press BodyGuard 545 Color Vision™ Directions For Use...
  • Page 43 11. If auto-bolus, the following screen appears: EPIDURAL 10:00 █ ■ make sure that auto bolus is in fact required. To A: Levobupivacaine confirm press Warning ! Patient will Periodically receive an automatic bolus. Press to Confirm BodyGuard 545 Color Vision™ Directions For Use...

  • Page 44: Titrating Basal Rate During Infusion

    The pump will beep to confirm acceptance of the change and the new rate will be displayed. NOTE: If the desired rate is above the protocol maximum range the pump will not  accept the entry and will display a message notifying the maximum rate allowed. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 45: Patient Activated Bolus

    NOTE: When a protocol is selected with the auto bolus feature activated the  pump will deliver the predetermined dose at a predetermined time without the need for a remote bolus request by the patient/operator of the device. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 46: Bolus Menu

    Change Bolus Dose: set a new bolus volume EPIDURAL 10:00 █ ■ A: Levobupivacaine and press . To confirm the change enter Change Bolus Dose code level one and press Press to Cancel Enter and Press BodyGuard 545 Color Vision™ Directions For Use...

  • Page 47: Clinician Activated Bolus

    Next autobolus due - If you wish to delay the auto-bolus press In 10 Minutes Press key to Confirm to Go Back Enter code level 2 and press BodyGuard 545 Color Vision™ Directions For Use...
  • Page 48 To infuse a Clinician Activated Bolus during an infusion, perform the following steps: During operation, press and then press to stop the current infusion and initiate the Clinician Bolus. Enter relevant Code and press BodyGuard 545 Color Vision™ Directions For Use...

  • Page 49: Interpreting The Display Screen During Infusion

    Time between two auto Auto-Bolus Dose 2 mL (When applicable) boluses (When applicable) Auto-Bolus interval 15 Minutes Auto bolus volume ██████ █████████ ████████ (When applicable) █ █ 110 of 350 mmHg Actual Pressure Bar BodyGuard 545 Color Vision™ Directions For Use...

  • Page 50: Mediguard Tm Option

    (multiplied by the maximal MediGuard rate). The calculated values will be displayed as 'Drug Limit' in program accumulation screen and during program operation. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 51: Automatic Bolus Rate Adjustment

    Automatic Bolus Rate Adjustment The BodyGuard 545 Color Vision™ has a special feature which optimizes bolus rate during infusion through narrow catheters such as Epidural catheters. The pump will attempt to deliver the bolus at the pre-set bolus delivery rate. If the pump senses back...

  • Page 52: Using History Functions

    It is not patient specific (i.e. the 2000 events are likely to span many patients recently treated with that particular pump). To access the events history: From the main menu scroll to ‘View Event Log’ and press BodyGuard 545 Color Vision™ Directions For Use...

  • Page 53: End Of Program/Infusion And Bag Change

    KVO rate (see “Change Set Up). The alarm will sound again every 4 End of Infusion minutes, until the user changes bag or stops the pump. Keep Vein Open Rate 2.5 mL/hr Press Key to Menu BodyGuard 545 Color Vision™ Directions For Use...
  • Page 54 NOTE: If using an infusion set with drip chamber, change to a new infusion bag,  but make sure that the drip chamber is half filled and there is no air in the administration set. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 55: Eliminating Air During Operation

    Press to resume the current infusion. Check the Infusion Summary if screen which shows: bag volume, volume left and infused, is correct then press again to restart delivery. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 56: Down Occlusion Alarm

    Down Occlusion Alarm After Down Occlusion Alarm press EPIDURAL 10:00 █ ■ Down Occlusion Check Set / Access Press key to mute Fix the obstruction in the I.V. line and press to continue. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 57: Alarm Conditions And Troubleshooting

    Alarms notify the clinician and/or patient of a potential or an actual hazardous condition. Terms Definitions High Priority A high-priority alarm is initiated by any alarm condition requiring BodyGuard 545 Color Vision™ Directions For Use...

  • Page 58: Definition Of Alarm Types

    Sound Pressure Level (SPL) for Alarm Signals Alarm Priority Min. Volume (dBA) Max. Volume (dBA) (Volume 1) (Volume 5) High Priority Alarm 53.0 61.4 Medium Priority Alarm 46.5 54.7 Low Priority Alarm 46.1 54.6 BodyGuard 545 Color Vision™ Directions For Use...

  • Page 59: Troubleshooting

    Cannula is blocked. Change the Cannula. Press key to mute activated Administration set Re-load the IV line. loaded incorrectly. NOTE: Operator may Refer to “Setting Down change pressure Occlusion” section. setting. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 60 Pump will Alarm not start Change the set to a A set different than MicroSet™ and load it the MicroSet™ was according to loaded in the pump. Load Set Key & Close Door instructions. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 61: View Set Up

    Simply scroll to a parameter you wish to view and press In this mode you can only view the parameters but cannot change any of the values which users can configure. BodyGuard 545 Color Vision™ Directions For Use...

  • Page 62: Change Set Up

    Once the user has changed or confirmed a parameter the pump returns to the ‘Exit’ choice. Press _to exit or scroll down to view/change another parameter (repeating step 3 above). BodyGuard 545 Color Vision™ Directions For Use...

  • Page 63: Pump Parameters

    Automatically test all pumps Main Self-test hardware features prime volume, continuous Volume Test Test the volume calibration rate, bolus dose, bolus rate, bolus lock-out Manual Test Manually test the pumps hardware Keypad test, display test, BodyGuard 545 Color Vision™ Directions For Use...
  • Page 64 & encoder test, pressure sensor test, electrical measurements of key components (voltages test) Exit Returning to previous menu NOTE: Only highlighted parameters can be changed (see ‘Change Set Up’).  BodyGuard 545 Color Vision™ Directions For Use...

  • Page 65: Specifications

    3. At low flow rates of 0.1 – 1 ml/hr this accuracy may not be achieved for short periods. During the total infusion time, the accuracy stabilizes. 4. Accuracy calculated with 90% probability at a 90% confidence level BodyGuard 545 Color Vision™ Directions For Use...
  • Page 66 Figure x2: The programmed vs actual cumulative volume for consecutive 0.1ml bolus deliveries. KVO rate: 0.1 to 5 ml/hr Air Sensor: Ultrasonic, adjustable air bubble size detection 0.04-1ml Occlusion Pressure Adjustable 250-1100mmHg Range: BodyGuard 545 Color Vision™ Directions For Use...
  • Page 67 Automatic when the pump is docked into the charger if connected to an AC power source. Eight hours needed to charge a fully-depleted battery. When a problem is detected, the BodyGuard 545 Color Vision Alarms: displays the following alarms: ...
  • Page 68 Relative Humidity: 15% to 90%, non-condensing Air Pressure: 70kPa (10000 ft, 3050 m) to 106kPa (-1260 ft, -384 m) *The system may not meet all performance specifications if operated outside of the conditions above. BodyGuard 545 Color Vision™ Directions For Use...
  • Page 69 Electrical Safety/EMC: The BodyGuard 545 Color Vision™ infusion system is designed to be in compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-24 (infusion pump). The BodyGuard Infusion pumps have been tested and found to comply with the limits for a Class B digital device.
  • Page 70 Complies, No degradation Interruptions cycle 135°, 180°, of performance 225°, 270° and 315° 0% for 1 cycle at 0° 70% for 0.5 at 0° sec. 0% for 5 sec. at any phase angle BodyGuard 545 Color Vision™ Directions For Use...

  • Page 71: Service And Maintenance

     NOTE: It is the CME technician's responsibility to repair any faults found during the Periodic Maintenance.  NOTE: Do not service the pump while it is in use and/or attached to patient.

  • Page 72: Battery Replacement

    AC icon is off. Warning: Do not operate the pump on AC power if the battery is not loaded in the pump for back up. Do not store the pump with the battery fully depleted. Warning: BodyGuard 545 Color Vision™ Directions For Use...
  • Page 73 NOTE: When 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. NOTE: Replace the battery once every two years.  BodyGuard 545 Color Vision™ Directions For Use...

  • Page 74: Limited Warranty

    CME’s obligation, or that of its designated representative under this Limited Warranty, shall be limited, at CME’s option, or that of its designated representative, to repairing or replacing pumps, which upon examination, are found to be defective in material or workmanship.
  • Page 75 BodyGuard 545 Color Vision™ Directions For Use...

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