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CME BodyGuard 575 Color Vision Operator's Manual

Pca infusion system, pain manager
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BodyGuard® 575
Color Vision
PCA Infusion System
Operator Manual
0344
Manufacturer:
Caesarea Medical Electronics GmbH.
23 Staufenburg st.
72805 Lichtenstein, Germany
International Toll Free: +800-323-575-00
www.cme-infusion.com
Contact e-mail: Sales@cme-infusion.com
EDITION February 2013
Ref.: 100-095XCV
Software ver. CVPCA30E_1
1

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Summary of Contents for CME BodyGuard 575 Color Vision

  • Page 1 BodyGuard® 575 Color Vision PCA Infusion System Operator Manual 0344 Manufacturer: Caesarea Medical Electronics GmbH. 23 Staufenburg st. 72805 Lichtenstein, Germany International Toll Free: +800-323-575-00 www.cme-infusion.com Contact e-mail: Sales@cme-infusion.com EDITION February 2013 Ref.: 100-095XCV Software ver. CVPCA30E_1...

  • Page 2: Table Of Contents

    Contents 1- Introduction Overview Keypad Descriptions and Functions The Charger System Safety Checks 2 – Symbols, Warnings and Cautions System Symbols Terms Used In Manual Intended Use Warnings 3 – Installation and Set up Unpacking Charging the Pump 4 – Operation Before Operating the Pump Pump Operation Test Air in Line –...
  • Page 3 Loading the Administration Set Priming the Set Modify Protocol Select Protocol (start an infusion) Titrating Basal Rate During The Infusion Patient Activated Bolus Clinician Activated Bolus Interpreting the Display Screen During Infusion MediGuard® Option Using History Functions End of Program/Infusion and Bag Change Eliminating Air During Operation Down Occlusion Alarm Review Set Up...

  • Page 4: 1- Introduction

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

  • Page 5: Keypad Descriptions And Functions

    Keypad Descriptions and Functions Front of BodyGuard® PCA infusion pump: 1. Display Screen  Displays pump and infusion status  Displays programming choices and instructions 2. Up Arrow  Scrolls up through options 3. START/ OK  Starts infusion  Confirms selection and setting 4.
  • Page 6 5. BOLUS  Administers bolus dose during PCA regimes (this function is normally performed using the remote bolus cable). Can be disabled under Change Set Up.  Activates clinician (CA) bolus when pump in STOP mode. 6. Power ON/OFF  Turn the system ON by pressing and holding the button until the Self-Test screen appears.
  • Page 7 BodyGuard® Infusion Pump with Door open Area Function Latch Holder Holds the door closed when latch is in vertical position. Pressure Sensor Detects downstream tubing restriction occlusion. Alarm level can be adjusted to suit patient needs. Keyway Guides the ADMINISTRATION line. Pressing Plate Connected to the door by two springs.

  • Page 8: The Charger

    The Charger Area Function Charger Display Displays major pump messages and operation values. Release Handle Push to release the pump from the Charger. Software ver. CVPCA30E_1...

  • Page 9: System Safety Checks

    System Safety Checks The following details outline the safety checks designed into the BodyGuard® pump to minimize the possibility of under or over infusions. Free Flow Protection When the set is installed in the pump and the door close two ridges on the door clamp the set so only the movement of the motor pistons can allow fluid to pass.

  • Page 10: Symbols, Warnings And Cautions

    2 – Symbols, Warnings and Cautions System Symbols The following symbols are used on the BodyGuard® 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 11: Terms Used In Manual

    Terms Used In Manual Warning: Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand this manual and all warnings completely before operating the BodyGuard® Infusion System. Caution: Indicates that the information is a caution.
  • Page 12 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. 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).
  • Page 13 Use aseptic technique. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components and do not re-use single use administration sets. Watch your fingers and nails when opening the pump door. When operating the pump on PCA program with a rate of 0.0 ml/h there is a hazard of blood clot forming.

  • Page 14: Installation And Set Up

    3 – Installation and Set up Unpacking Carefully remove the pump and Charger from the box. Make sure no items were damaged during shipment Make sure you have the following items:  BodyGuard® Infusion Pump  Charging Cradle with Power Cord or Battery Charging Cable ...

  • Page 15: Charging The Pump

    Charging the Pump  NOTE: 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. Be sure that the battery is fully charged at all times. Warning: If the battery is removed during operation while pump is not connected to a charger connected to mains, the pump will turn...

  • Page 16: Operation

    4 – Operation Before Operating the Pump Before attaching the system to a patient, run the following tests to verify that all indicators and alarms work properly. When an alarm is activated the following occurs:  An alarm message appears on the display ...

  • Page 17: Air In Line - Alarm Test

    Air in Line – Alarm Test Insert a BodySet® administration set and close the door. Press the door until a click is heard.  NOTE: For instructions on how to load and prime an administration set refer to sections “Loading the Administration Set” & “Priming the Line”. Insert air into the ADMINISTRATION line to allow an air bubble greater than 10 mm to enter into the administration set.

  • Page 18: Door Open - Alarm Test

    Door Open – Alarm Test Insert a BodySet® in the pump and close the door. Press the door until a click is heard.  NOTE: For instructions on how to load and prime an administration set refer to sections “Loading the Administration Set” & “Priming the Line”. Press until the Self-Test screen appears.

  • Page 19: Charger Indicator Test

    Wait untill pump displays “low battery” message Press to turn the pump off. Connect the pump to a charger. Verify the red icon of battery is lit (on the charger). Verify the red battery turns green after a minimum of 2 hours. WARNING: Do not let the pump operate when battery is fully discharged.

  • Page 20: Operating The Bodyguard® Pca Pump

    Operating the BodyGuard® PCA Pump  NOTE: Before using the BodyGuard® for the first time please ensure you have carried out the 'pump operation tests’ as detailed in the previous chapter. These tests should be carried out periodically to ensure all systems are functioning correctly.
  • Page 21 Keypad Lock To Lock Keypad Press and hold until the entire graph is black and a beep is heard. The beep indicates that the locking program is turned ON.  NOTE: The keys are locked in memory until they are unlocked or until entering Change setup mode.

  • Page 22: Dedicated Bodyguard® Administration Sets

    Dedicated BodyGuard® Administration Sets The BodyGuard® Infusion System should be operated only with BodySet® dedicated Infusion sets. Warning: Do not operate the BodyGuard® Infusion System with any administration set, other than the BodySet®/MicroSet®. The BodySet®/MicroSet® Infusion Sets are equipped with a free flow protection valve, to prevent a gravity free flow hazard.
  • Page 23 Warning: Drugs must not be administered to the Epiduralspace unless the drugs are indicated for this purpose and are administered in accordance with the indications included in the manufacture’s package insert accompanying the drugs. PCA administration of drugs other than those indicated for Epidural use could result in serious injury to the patient.

  • Page 24: Loading The Administration Set

    Loading the Administration Set  NOTE: Follow the instructions supplied with the individual administration set. Warning: Use of any administration set, other than the BodySe/MicroSet®, may impair the operation of the pump and the accuracy of the Infusion. Lift the door latch (on the right side of the door) to open the BodyGuard® pump door and remove the administration set from the sterile packaging leaving the end caps on the line.

  • Page 25: Priming The Set

    Priming the Set Once the set is loaded turn on the BodyGuard® pump, by pressing The screen than will prompt for level one code. Enter code 700 and press From the menu select "Prime" by pressing Make sure patient is disconnected from the I.V. line BodyGuard®...

  • Page 26: Modify Protocol

     NOTE: In case of setting the pump for another user, after priming is completed the following must be done to prevent uncontrolled priming by the user:  In the menu scroll to “select protocol” and start a new protocol (see instructions in next pages).
  • Page 27  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.
  • Page 28 Enter relevant code using the numerical keypad.  NOTE: The BodyGuard® has a system called MediGuard® which can be activated under "Change Set Up" menu. When this feature is set to ON the pump will prompt for the patient's weight at this stage of entering the protocol.
  • Page 29 Repeat the last step as required in order to edit the protocol name. To insert a space in text position the cursor in the top left blank space of the grid and press . The maximum name size is 40 letters (20 on the upper row and 20 on the lower row) including spaces.
  • Page 30 To confirm concentration of mg/ml Enter the correct value and press . To confirm concentration of mcg/ml press Enter the correct value and confirm with . The rate now will be set in the relevant units. Use the numeric keypad to enter the value/ Press when done.
  • Page 31 Set the Lockout time and confirm with Change or accept the 1,4 or 24 hour limit. If the lock out screen would not appear, than the lock out option is set to OFF. This can be changed under the "Change set up" option. To turn the limit OFF enter 0, then press Depending on how this has been configured under "Change set up"...
  • Page 32 Confirm the protocol data by pressing or review by pressing Once you confirm your protocol changes you will see the infusion summary screen which details the bag volume set up, volume left in the bag, volume infused (will read 0 if you selected ‘New Patient - OK’ when entering ‘Modify Program’...

  • Page 33: Select Protocol (Start An Infusion)

    Select Protocol (start an infusion) Under normal, everyday circumstances most users of dedicated infusion pumps use the pumps to perform the same or limited number of infusion protocols for the majority of patients. For example, in pain management it is common for patients to be on a morphine regime consisting of bolus only delivery of a concentration of 1- 2mg/ml morphine supplied by pharmacy in a fixed infusion bag volume.
  • Page 34 To prime the set select "Prime" and confirm with . Prime as explained in the priming section of this manual. WARNING: Do not attach the set to the patient’s access device before priming the administration set. From the menu select "Protocol" by scrolling with the arrow keys and pressing The display will show: ‘New Patient’.

  • Page 35: Titrating Basal Rate During The Infusion

    Press_ to confirm. Scroll to select Protocol required then press Review screen is displayed showing infusion parameters for the protocol you selected. Check infusion rate, bolus volume, lockout time and 4 hour limit are correct before proceeding.  NOTE: When MediGuard® is enabled and the max. rate allowable for the current patients weight has been exceeded than the pump wil alert "MediGuard®...

  • Page 36: Clinician Activated Bolus

    Using a Bolus Cable for PCA SAFETY CHECK: Prior to connecting the bolus cable to the pump test the bolus cable. Press and release the handset button – you should feel and hear an audible click each time. If you do not then the probability is that the handset is damaged and should be removed from use.
  • Page 37 Enter Relevant Code and press Enter the volume of the Clinician Bolus and press to begin priming procedure. You may stop the bolus at any time by pressing The Volume for the Bolus will be in ml, mg or µg depending on the settings of the existing protocol entered for the PCA infusion.
  • Page 38 Enter the volume of the Clinician Bolus and press begin priming procedure. You may stop the bolus at any time by pressing The Volume for the Bolus will be in ml, mg or µg depending on the settings of the existing protocol entered for the PCA infusion.

  • Page 39: Interpreting The Display Screen During Infusion

    Interpreting the Display Screen During Infusion Battery Status Indicator Protocol & Protocol Letter Basal Rate (ml/hr or mg/ml) Preset Bolus Patient Controlled Limits Bolus Volume Actual Pressure Protocol The currently selected protocol letter (A-Z) appears in the left hand margin of the display.

  • Page 40: Mediguard® Option

    MediGuard® Option MediGuard® option enables the medical staff to control the maximal rate of drugs approved to a specific patient based on the patient’s weight. To enable this option, enter “Change Set Up” option and scroll to Program Limits. Press start/ok to access and set MediGuard® on. Press key to approve.
  • Page 41 Setting a protocol based on a combination of boluses and basal rate (or only boluses) Pump will enable program operation only if the basal rate set is equal or less than maximal MediGuard® rate (If rate is out of limits, pressing start/ok from accumulation screen will display “drug limit overflow”...

  • Page 42: Using History Functions

    Using History Functions The BodyGuard® keeps a rolling 24 hour history of the current patient’s infusion delivery. In this section we will address how this can be used. There is also a 500 event history log keeping track of the last 500 user actions in a date and time stamped record.
  • Page 43 The screen will now show the most current user event, date, time, etc. For example:  NOTE: Each event is assigned a new number and the pump stores the last 500 in memory. After some time the first event to appear when you enter the events history may be number 754.

  • Page 44: End Of Program/Infusion And Bag Change

    End of Program/Infusion and Bag Change Once the infusion had reached to an end (Pre-set volume was infused), an alarm sounds and display will show: The alarm will stop after 4 beeps. The pump will show the pre-set KVO rate (see “Change Set Up). The alarm will sound again every 4 minutes, until the user changes bag or stops the pump.

  • Page 45: Eliminating Air During Operation

    If using an ambulatory administration set without a drip chamber, priming the line might be needed. Disconnect the set from patient before priming. Eliminating Air During Operation When air is detected in the line, the pump gives an audible alarm, the screen shows AIR IN LINE, and the LED indicator turns from green to red.

  • Page 46: Review Set Up

    Fix the obstruction in the I.V. line and press to continue. Review Set Up Selecting ‘Review Set Up’ from the main menu and pressing allows you to scroll through, select and view any of the default parameters or events history. 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.

  • Page 47: Bodyguard® Default Settings

    BodyGuard® Default Settings The pump comes programmed with a number of default parameters that can be viewed using ‘Review Set Up’ from the main menu and changed using the technician Access Code in ‘Change Set Up’ mode. PARAMETER PURPOSE RANGE Battery Level Current battery charge Empty >>...

  • Page 48: Alarm Conditions And Troubleshooting

    5 – Alarm Conditions and Troubleshooting Alarm Condition When the infusion pump detects a problem, four things occur:  The infusion stops  An audible alarm is activated  A message appears on the display screen indicating the cause of the alarm ...
  • Page 49 Troubleshooting Description Result Possible Cause Required Action Infusion stops Air is present in administration Disconnect line from patient and and an alarm is Set. press STOP/NO key to move to activated Pump stopped screen. A long press (3sec) on the STOP/NO key The roller or clip on the followed by a normal press on administration set is closed...
  • Page 50 Description Result Possible Cause Required Action Infusion stops Fatal internal error has occurred Restart the pump. If the alarm does not stop pack the pump properly, in its original packaging, and send it for service. Program ends, Current infusion program has Press STOP/NO to restart a new pump will turn to been completed.

  • Page 51: Specifications

    6-Specifications 6 – Specifications Pumping Mechanism: Piston Pump Flow Rate: 0 to 100 ml/hr in 0.1ml increments Priming Rate: 300ml/h to 425ml/h (default 400ml/h) Total Infused Volume: 0.1 to 1,000 ml. Total Time Setting: 100 hours Accuracy: ±5% KVO rate: 0.1 to 5 ml/hr Air Sensor: Ultrasonic, adjustable air bubble size...
  • Page 52 6-Specifications  Pump unattended NOTE: When this symbol is seen, consult accompanying documents. BodyGuard® 112 x 89 x 32mm. (L x W x H). Dimensions: Classification Type CF Equipment (degree of protection against electrical shock) Housing: PCABS (fire retardant)  280 grams without battery Weight ...

  • Page 53: Service And Maintenance

    7 – Service and Maintenance Cleaning Before connecting the pump to a patient, and periodically during use, clean the unit using a lint-free cloth lightly dampened with warm water and a mild detergent or disinfectant. Warning: Always turn the pump off and remove the battery before cleaning. Warning: Always unplug the charger from AC power before cleaning.
  • Page 54  Note: After the “End Battery“ signal has been activated or following long periods of storage, wait 2 minutes after the pump has been connected to an AC power supply before operating. Caution: Leaving the battery in an uncharged state for a long period of time may damage the battery.

  • Page 55: Pump Accuracy

    Pump Accuracy The following graphs and curves were derived from testing described in IEC60601-2-24. Testing was performed under normal conditions at room temperature (72 F). Any deviations from normal conditions and room temperature may cause changes in the accuracy of the pump. Start-up Curves The Start-up curves represent continuous flow versus operating time for two hours from the start of the infusion.
  • Page 56 Software ver. CVPCA30E_1...
  • Page 57 Software ver. CVPCA30E_1...

  • Page 58: 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.

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