Bodyguard 545 Manual

.Infusion System Operator Manual 0344 Caesarea Medical Electronics Ltd. 16 Shacham street Borkstrasse 10 Industrial Park Caesarea North 48163 Muenster P.O.Box 4294 Caesarea 38900, Israel Germany sales@cme-infusion.com T: +49 251 32266 0 www.cme-infusion.com October 2014 Ref.: 100-090TO Rev. 1.0. NOTE: To assure proper use of the, C.M.E urges all users to read this manual carefully, become familiar with the procedures and system functions, and follow all recommendations herein. Federal law restricts this device to sale by or on the order of a physician.Door Open – Alarm Test (Channel 1).23 Battery Test.24 Charger Indicator Test.25 Dedicated BodyGuard 121 Twins Administration Sets.25 The BodyValve. 25 The BodySet.26 Loading the Administration Set.27 Priming the Line (same for both channels).Continuous Infusion.34 TPN Infusion.39 Setting Down Occlusion.42 Program Delay.43 Dose Program.44 Intermittent Infusion (Optional).47 Program Delay.51 25 Steps Protocol (Optional).54 PCA Infusion (Optional).56 Lock Mode.Introduction Overview The BodyGuard 121 Twins provides the following features: 2 Channels pump  Small, light, and compact pump.

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 Multi Program:  Continuous program. Continuous Infusion Rate: 0.1 to 1200ml/hr. Volume: 0.1 to 9999ml. Bolus Volume: 0-100ml Rate taper program, with programmable up and down time.Operated with a customized safe administration set  Rechargeable internal lit-on battery.  Can be latched into a Charger, which is mounted on an IV pole  Anti-free flow protection valve on CME administration sets (optional). Anti-Bolus System  Silent operation .Keypad Description and Functions Front of BodyGuard Infusion Pump 1. Display Screen  Displays pump/infusion status  Displays programming choices & instructions 2.

Up Arrow  Scrolls up through options 3. START/ OK  Starts infusion.  Confirms selection and setting. Prime Bolus  Pressing Prime/Bolus key followed by Start/OK key during data setting: Enable Priming procedure. A graph appears on the display screen showing the priming volume with the current value increasing until reaching the set volume. Priming default volume: 20 ml. .BodyGuard 121 Twins with Door Open Area Function Latch Holds the door closed when holder latch is in vertical position.

Pressure Detects downstream tubing sensor restriction occlusion. Alarm level can be adjusted to suit patient needs. Keyway Guides the IV line.The Charger Description Pump channel one led Green when channel I is infusing, Red when channel I is being programmed or under alarm, idle when channel II is on display. Battery charging led Red when the battery is empty and being charged Battery charged led Red when the battery is fully charged Channel one charger display.IV line pressure through the in-line pressure detection system.

Air-in-Line Accumulation To improve the detection of air in the IV line, the BodyGuard 121 Twins Infusion 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 of 1 ml over a moving window of 15 minutes.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.Trumpet and Flow Rate With the BodyGuard 121 Twins, as with all infusion systems, the action of the pumping mechanism and variations cause short – term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1.2 – Symbols, Warnings, and Cautions System Symbols The following symbols are used with the BodyGuard Infusion System and components. Labels on the system or statements in this manual preceded by any of the following words and/or symbols are of special significance intended to help you operate the pump in a safe and successful manner.BodyGuard Infusion System. Intended Use The BodyGuard 121 Twins™ infusion pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site).Before operation, verify that the IV line is not kinked or occluded. The BodyGuard 121 Twins should be operated only with IV lines approved for use by the manufacturer and distributor.

Use of IV lines other than the approved type may impair the operation of the pump and the accuracy of infusion.Clean solution spills on the pump immediately. Use a damp cloth or sponge. A mild detergent may be used.

Wipe thoroughly with a dry cloth. Immersing the BodyGuard 121 Twins Infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid.Charging the Pump  NOTE: The pump is protected against overcharging.

Connect the pump to the mains via the charger whenever possible to be sure that the battery is fully charged at all times. Warning: If the battery is damaged during operation, while pump and charger are disconnected from mains, the pump will turn off.Pump Operation Test (Channel 1) Click the pump into a Charger connected to AC power. Verify that the CHARGE Red LED on indicator is on (on charger). The charger Insert an administration set, on left (green) channel, and close the pump door.

Press the door until a click is heard.Air in Line – Alarm Test ( Channel 1) Insert an administration set in Channel 1 and close the pump door. Press the door until a click is heard. Switch the pump on.  NOTE: For instructions on how to load and prime an administration set refer to sections “Loading the Administration Set”.Press until the self-test screen appears. The pump displays Channel 1 and the program selected. Press the Start/OK key to display the last rate setting.

If air sensor is off, press to confirm. Set the infusion rate at 500ml/hr, using the numeric keypad Rate 500 ml/h and press to display last volume set.The pump displays Channel 1 and the program selected. Press to change the display to show the last rate setting. If air sensor is off, press to confirm. Set the infusion rate at 500ml/hr, using the numeric keypad Rate 500 ml/h and press to display the last set volume.Connect the power cord to the AC power outlet.

Verify that the CHARGE LED indicator is on. Administration Sets The BodyGuard 121 Twins infusion System should only be operated with Infusion sets approved for use by the manufacturer and distributor.Set Based Anti Free-Flow Valve The Anti free flow valve, BodyValve, 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.Insert the IV tubing into the pumping canal. Insert the tubing from top down, and avoid stretching or pulling the tubing.

Ensure that the distal flow valve is on the right hand side of the pump if using a CME set or one that contains an anti-siphon valve.BodySet and MicroSet administration sets contain a one-way Anti-Siphon valve also called Free-Flow valve. Therefore, the lines cannot be primed using gravity and must be primed using the BodyGuard 121 Twins priming function.

Prime function must be used.When the display screen shows the existing program press PRIME DISCONNECT PATIENT key to prime the administration set. Press OK to Start Warning: Ensure the set is not connected to the patient!!! Press to start priming. You may stop priming at any time by pressing The display screen will show a progress bar indicating the PRIME 10ml.Connect the charger via a standard power cord to a grounded AC outlet.

Open channel 1 pump door and load the administration set into the pump’s tubing canal. Repeat, same operation, if necessary, for channel 2. Turn on the BodyGuard 121 Twins pump, by pressing key until the self-test screen appears.Warning: Verify that infusion proceeds normally before inserting the infusion bag and pump into the carrying bag.

Programming The BodyGuard 121 Twins infusion system features two different programming options:  Dose Program  Dose: 0.1 to 250 kg in 0.1kg units.Keep Vein Open Mode The BodyGuard 121 Twins Infusion pump uses a Keep Vein Open (KVO) mode that runs automatically at the end of a program, if desired. KVO can also be set to run during a delay at the start of a program. The KVO rate can be set from 1-5 ml/hr with an initial default setting of five ml/hr.End Program Mode When a protocol has completed, an audible alarm will sound continuously and the display will indicate END PROGRAM – KVO (assuming KVO is enabled).

To stop the alarm and enter a new program, press. If the stop key is not pressed before the first 4 beep have sounded, KVO will begin automatically. KVO will run for four minutes.Turn on the BodyGuard Pump, by pressing until the self-test screen appears. Press key to enter channel 1 and display the program selected. Immediately press and hold for two seconds. Scroll to the required program and press Select Program CONTINUOUS.The screen displays the last set volume.

Volume 456 ml Do one of the following:  Press to confirm the existing parameters. Press OK Key  Enter the desired volume using the numeric keypad and press Enter delay time, if applicable. For further information regarding delay option – refer to delay program section.To change the rate while in Stop mode: Press first during infusion. Press any number on the keypad to return to the Continuous screen. Press to proceed to the rate screen. Adjust the rate and press Adjust the volume and press .Operation Led Scroll to 'Time Option' and press Time Option Delay Before Start Resume Press OK Press, to turn Time Option ON. Repeat Press NO Press twice.

If the previous program was not completed, the pump disaplys the following screen: Do one of the following: .During program operation pump displays the time left for the current program in each channel. The charger will display operation rate on each channel.  NOTE: If one of the values is changed during the programming mode, the pump will not recall the new value, unless changes are confirmed by pressing If prime procedure is activated during data setting, the pump will return to the original (previous) screen, once priming has completed.4-Operation – Intermittent Infusion TPN Infusion Total Parenteral Nutrition - This mode delivers an infusion while automatically tapering up and down.

The pattern of the program is a trapezoid. Rate TPN Trapezoid Program Max Rate T1 = Time UP T2= Time FLAT T3= Time DOWN Time On a TPN Program the operator may set the total volume which corresponds to the size of the bag to be.4-Operation – Intermittent Infusion Channel 1 Press. Wait for the Volume screen to display. TPN PROGRAM Total volume ml  NOTE: If pump is not already in TPN Program refer to changing program section for instructions.  NOTE: Whenever you decide to set a new program, follow instructions at the bottom of each screen.4-Operation – Intermittent Infusion The screen displays the time for rate to taper down.

Press Down Time 0:30 to confirm the existing parameters or enter the Press OK key desired value (up to 4:15 h) and press The pump calculates the set data and displays the Volume 1500 ml accumulation screen, including the maximal rate for the Maximal Rate: 127 ml/h.4-Operation – Intermittent Infusion  NOTE: Whenever required to stop infusion, press. Stop message is then displayed on the screen.

Stop mode is limited for two minutes. After two minutes an audible alarm sounds. Press again to mute the alarm. .4-Operation – Intermittent Infusion  NOTE:  The following pressure parameters can be set:  Low - 5 psi (0.3 bar)  Normal - 7.5 psi (0.5 bar)  High - 10 psi (0.7 bar)  The selected pressure level will remain in memory until it is changed or the pump is turned off.4-Operation – Intermittent Infusion Scroll to select “delay before start” and press Time option Delay before start Language Turn delay option ON by pressing Press and the screen displays Restart Pump Press to continue.

Setting delay befor start Volume 456 ml After setting the program data pump enables setting the delay (if applicable).4-Operation – Intermittent Infusion Continuous Press and hold the Stop/No key to enable the program  Dose selection menu. Use one of the arrow keys to scroll to Dose option and press Start/OK. In the following four screens the user will have to set the patient’s weight, the concentration of the drug, the actual dose, and the volume to be delivered.4-Operation – Intermittent Infusion After pressing Start/OK, the pump would begin the infusion Dose 100 mcg/kg/min and would display the screen below. The LED would blink Weight 10 kg green and the battery icon would be displayed on the right Rate 6 ml/hr side of the display screen.4-Operation – Intermittent Infusion  NOTE: As a safety feature, especially in pediatric hospitals, the pump can be configured to have a Max. Bolus Limit option in the Adjust Settings menu. The rate at which the bolus is infused is configurable in the Adjust Settings menu – NOTE: it will not be adjustable every time a bolus is initiated.4-Operation – Intermittent Infusion  NOTE: When returning to a program, the screen will display the last set program. Bag Volume Screen Bag Vol: ml Do one of the following: Enter & press OK  Press to confirm the existing parameters.

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.4-Operation – Intermittent Infusion  NOTE: If pump is in Delay Mode, enter Start Time (24 Hour Clock) and Start Date. For further information regarding the Delay Option, refer to Delay Program section. Press to Start Infusion. Delay time option is Next Dose disablde, screen will show start time as “Immediate”.4-Operation – Intermittent Infusion  NOTE: During programming, you may backspace by using Pressing once clears the last entered digit. Pressing again clears the next number. Pressing when the value is empty displays the original value or the previous screen. Resume Infusion, Start New Bag, or Reprogram Infusion When an Intermittent infusion is stopped and the pump is re-started, the operator has the following options.4-Operation – Intermittent Infusion Program Delay The option to Delay Program Before Start can only be used in the Intermittent Mode.

Turning the Delay Option ON Press twice from STOP or setting mode. Warning: If air sensor is off, please contact your technician in order to enable the air sensor. Using the pump with air in line detector off may cause an embolism resulting in death or paralysis.4-Operation – Intermittent Infusion Time Option Scroll to 'Delay Before Start' option and press Delay Before Start Language Turn delay option ON by pressing Press and the screen displays Restart Pump Press to continue. Setting the Time for “Delay Before Start” After entering the program data, the pump enables setting the Delay Before Start time (when Delay Before Start is turned ON).4-Operation – Intermittent Infusion KVO During Delay Screen 4/ 8/2005 12:05 During delay time, pump will operate in KVO mode. Time left Start Time 18:30 will count down until 00:00 and will then automatically start Start Date 04/08/05 the progrmamed infusion. During the delay, this screen will Press OK to Start be displayed showing when the infusion will start.25 Steps Protocol (Optional) This protocol permits programming of up to twenty-five different steps. Each step has its own rate and volume.

Step accumulation is limited to a Volume of ten (10) liters. Protocol steps are delivered sequentially until all steps are completed. .Rate Screen – Step 2 Step 2 Rate Pump displays the rate for step 2. Repeat the same ml/h instructions for step 1 and repeat until the required number Press OK for Volume of steps is entered.

Step 5 Rate After entering the last required step, press without ml/h.PCA Infusion (Optional) Patient Control Analgesia is a program used for patients who require IV pain management or epidural analgesia. Pain management is administered through a continuous basal rate, in combination with pre- programmed boluses. The pump will deliver only the boluses corresponding to the preset time intervals. All bolus features are stored in the pump memory.Priming  NOTE: Priming is disabled during PCA operation. Always prime the set before starting a program. Warning: Always disconnect IV tubing from patient before starting the priming procedure. Selecting the Prime option from the PCA menu, the screen Prime will show the priming screen.Rate ml/h Rate or Concentration Screen Do one of the following: Adjust & press OK  Press to confirm the existing parameters.

Concentration  Enter the desired rate or concentration and press mg/ml Concentration micrograms/ml  NOTE: To change from Concentration back to Rate, enter 0 (zero) for Concentration and press Rate mg/h.Lock: Press OK Locking Screen Review: Press NO The pump automatically locks before a PCA infusion program can be completed. Do one of the following:  Press to lock the PCA program and proceed.  Press to scroll through and review the program or adjust parameters.Press the button on the end of the bolus cable. The bolus cable plugs into the side of the pump where a label reads “Bolus”  NOTE: Administering boluses via a bolus cable is dependent on a bolus connection and cable. Not all BodyGuard 121 Twins are equipped with such devices.

Using Keypad Press the button on the keypad. NOTE: User can stop a bolus at any time by pressing  If patient requests more boluses than are allowed, the pump will display “Bolus Locked” NOTE: and will continue to track the amount of boluses requested by the operator. The bolus history can be reviewed by a physician/clinician by scrolling the Info Menu.during To infuse a Clinician Activated Bolus a PCA infusion, perform the following steps: During operation, press and then press stop the current infusion and initiate the Clinician Bolus. CA Bolus Code Enter Level 2 Technician Code and press Enter & press OK Enter the volume of the Clinician Bolus and press Clinician Bolus Volume.PCA Restart Menu = Resume This screen displays when: New Bag (1) The pump is turned OFF and back ON in PCA mode. Unlock Program Select and press OK (2) Infusion is stopped by pressing and holding User can scroll through the following options by pressing .Lock Mode The BodyGuard provides two different levels of locking:  Level 1: Keypad Locking During operation all keys are disabled excluding the STOP/NO and the INFO key. During programming all keys are disabled excluding the START/OK and the INFO key.

.Info Mode Access the info mode by pressing during operation, data setting or while in the Stop mode. Pressing during program operation will display the following: Number of Infusion Mode Information Screen button presses All programs Infused Volume Infused Total Volume to Be Infused 500 ml 1000 All programs.Number of Information Screen button presses Infused Volume Infused Total Volume to Be Infused Pressing STOP/NO will clear Volume Infused. Option Selection screen Volume Infused 500 ml 1000 Review set up Change set up To change parameters, select Change set up, press Start/OK anf follow instructions in the Change set up section.Review set up The Review set up feature is designed to allow you to view the programmable options and other important information about the pump. In View set up, the current setting can be viewed, but cannot be changed.

Press twice.Air-in-Line-Limit Current air bubble size setting Operation LED Option currently ON or OFF Time option Option currently ON or OFF Delay before start Option currently ON or OFF Language Current pump messages language Serial Number Pump Serial Number Production Date Pump production date Operation time Hours since last Service Calibration.Change Set up The “Change Set up” mode allows you to make changes to various parameters. To access Change Set up: Press twice. Volume Infused Scroll to 'Change set up' option. Press Review set up Change set up To adjust Pressure Level or Buzzer Level: Change set up: Press to select an option and press.The table below indicates the adjustable parameters Screen No.

Screen Information Action Pressure Level Choose pressure level (High 10 psi, Normal 7.5 psi, Low 5 psi). Adjust the buzzer level. Note: the buzzer cannot be muted for Buzzer Level safety reasons.

Code 901 Restart pump Restart pump Select pressure default (High 10 psi, Normal 7.5 psi, Low 5 psi).Enable changing the language of pump messages (only for Language models, in which the softwae includes more than one language). Set Time & Date Set actual time and date. Event Log Channel I Indicates injection history.

Event Log Channel II Indicates injection history. Restart Pump Reboots the Pump and returns to openning screen.The conditions listed in the following table activate an alarm: Troubleshooting (on the relevant channel) Description Result Possible Cause Required Action Air in Line Infusion stops and an alarm is Air is present in administration Disconnect line activated. From patient, press Air in Line STOP/NO.Door Open Infusion stops and an alarm is The door of the pump was not Close the Door of activated. Closed properly prior to the pump. Door Open operation. The operation led for the relevant channel will blink red. The door has accidentally Close Door opened during operation.Lock Out Setting cannot be changed.

Lock Out mode is turned on. No action required. If changing The operation led for the program is required Locked – unlock the pump relevant channel will blink red. – refer to lock section for further instructions.6 – Specifications Channels Two independent channels. Pumping Mechanism: Piston Pump Flow Rate: 0.1 to 100 ml/hr in 0.1ml, 100 to 1200ml/hr in 1 ml increments. Priming Rate: 600 ml/hr Total Infused Volume: 0.1-9999 ml Total Time Setting: 100 hours Accuracy: ±.Alarms: When a problem is detected, the BodyGuard displays the following alarms:  Air in line  Down Occlusion  Pump Unattended  End Program  Low Battery  End Battery  Door Open  Fatal Error  Lock Mode .BodyGuard Dimensions: 146 x 84 x 40mm.

Classification Type CF Equipment (degree of protection against electrical shock) Housing: (fire retardant)  Weight 435 gr. Without battery  545 gr.

With battery  460 gr pump charger Complies with: EN 60601-1 (Medical Electrical Equipment Safety), Electrical Safety IEC 60601-2-24 (Infusion pumps and controllers), IEC 60601-1-4. Accessories (optional) Bolus cable  Charging cable  Small bag  Large back bag.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.Battery Operation The BodyGuard pump can operate on battery power, enabling operation when the patient is being moved or during electrical power failure. When the pump operates on battery power, the AC icon is off.

At full charge, the battery provides 7.5 hours of operation at an infusion rate of 125 ml/hr. Warning: Do not operate the pump on AC power if the battery is not loaded in the pump for back up.This Limited Warranty is the sole and entire warranty pertaining to CME’s products and is in lieu of and excludes all other warranties of any nature whatsoever, whether stated, or implied or arising by operation of law, trade, usage or course of dealing, including but not limited to, warranties of merchantability and warranties of fitness for a particular purpose.