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CME BodyGuard 121 Twins Operator'S Manual Download Page 75

 

 

 

 

75

 

6 – Specifications

 

Channels 

 

Pumping Mechanism: 

Two independent channels. 

 

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: 

± 5 %. 

 

 

KVO rate: 

0.1 to 5 ml/hr. (to be set) 

 

 

Air Sensor: 

Ultrasonic, adjustable air bubble size 

 

 

Maximum Pressure: 

0.7 bar or 10 psi Adjustable (high/normal/low) 

 

 

Power Supply: 

110-240 VAC, 50/60 Hz.   0.3A max. 

 

 

Battery: 

Rechargeable Li-ion Polymer 7.4V, 1800mAh. (Typical) 

 

 

 Battery Operation at 125 ml/hr: 

7.5 hours  

 

 

Battery Charging: 

 

Automatic  when  clicked  into  the  Charger  that  is  connected  to  an  AC 

power source. Four hours needed to charge a fully-depleted battery.    

Summary of Contents for BodyGuard 121 Twins

Page 1: ...on System Operator Manual MedNet GmbH Borkstrasse 10 48163 Muenster Germany T 49 251 32266 0 Caesarea Medical Electronics Ltd 16 Shacham street Industrial Park Caesarea North P O Box 4294 Caesarea 38900 Israel E sales cme infusion com W www cme infusion com 0344 ...

Page 2: ...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 U S A federal law restricts this device to sale by or on the order of a physician ...

Page 3: ...peration Test Channel 1 21 Air in Line Alarm Test Channel 1 22 Down Occlusion Alarm Test Channel 1 22 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 28 Priming Operation before starting a program 28 Prime Operati...

Page 4: ...elay 51 25 Steps Protocol Optional 54 PCA Infusion Optional 56 Lock Mode 64 How To Lock 64 Info Mode 65 View set up 67 Change set up 67 5 Alarm Conditions and Troubleshooting 71 Alarm Condition 71 Troubleshooting relevant channel 72 6 Specifications 75 7 Service and Maintenance 79 Cleaning 79 Storage 79 Battery Operation 80 LIMITED WARRANTY 81 ...

Page 5: ... to 250kg in 0 1kg units Volume 0 1 to 99 9ml in 0 1ml units 100 to 9999ml in 1ml units Optional Patient controlled analgesia Continuous delivery plus or programmable boluses Bolus volume 0 25 5ml Clinician bolus volume 0 1 100ml Bolus rate 0 1 1200ml hr Optional A set dose delivered in set intervals Between intervals the pump will keep vain open KVO mode Optional Operator can design a specific pr...

Page 6: ...tion 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 A B S Anti Bolus System Silent operation Drop sensor control optional on both channels RS232 data collection Bolus Cable optional ...

Page 7: ...ramming choices instructions 2 Up Arrow Scrolls up through options 3 START OK Starts infusion Confirms selection and setting 4 STOP NO Stops infusion Silences an alarm condition Pauses priming Zeroes the displayed value during programming Erases the last digit during programming Returns to previous screen 11 1 3 2 5 6 4 9 8 10 7 ...

Page 8: ...ted 7 Select Channels key Allows the user to move between channels 8 Two Operation LED one for each channel Green Indicator Lights RED during system self test An intermittent green light indicates infusion delivery on the selected channel and lights continuously on the other channel Red Indicator Indicates an alarm state with a continuous red light Blinks when the pump is in a stand by mode during...

Page 9: ... and occlusion Alarm level can be adjusted to suit patient needs 3 Keyway Optional Guides the IV line 4 Pressing Plate Connected to the door by two springs 5 Pump door Covers the pressing plate 6 Air sensor front Ultrasonic air detector which is mounted on the front housing 7 Air sensor door Mounted on the door 8 Flow Direction Shows direction of pump operation 1 6 7 2 3 8 5 4 ...

Page 10: ...ttery is empty and being charged 3 Battery charged led Red when the battery is fully charged 4 Channel one charger display Displays channel I data 5 Channel two charger display Displays channel II data 6 Mains led Red when the pump is connected to mains 7 Channel two pump led Green when channel II is on display Red when channel II is being programmed or under alarm idle when channel I is on displa...

Page 11: ...tection 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 The limit is ...

Page 12: ...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 They exhibit the delay in onset of delivery due to mechanical complexity and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Tests performed according to ...

Page 13: ...ed over particular time periods Observation windows as opposed to continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various ...

Page 14: ...14 ...

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Page 16: ...onformance 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 ...

Page 17: ...s intra arterial epidural enteral in close proximity to nerves and into an intraoperative site soft tissue body cavity surgical wound site The system is intended for patients who require maintenance medications analgesics PCA therapy parenteral and enteral nutrition fluids chemotherapeutic agents blood or blood products infusion and general fluids therapy in hospital and home care environments War...

Page 18: ...ral administration of drugs other than those indicated for epidural use could result in serious injury to the patient For epidural administration of drugs use MicroSet only Any adjustments maintenance or repair of the uncovered pump may impair the operation of the BodyGuard 121 Twins Infusion System and or the accuracy of infusion Any adjustments maintenance or repair of the uncovered pump should ...

Page 19: ...ge the battery Do not store the pump with the battery fully depleted Xylene Acetone or similar solvents could cause damage to components Do not clean the pump with these chemicals 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 com...

Page 20: ...charged when the full battery LED symbol turns red charger upper left side above channel I 4 Remove the pump from the charger by releasing the safety screw and lifting the pump out of the charger Caution Leaving the battery discharged for a long period of time may damage the battery 4 Operation Before Operating the Pump Before attaching the system to a patient run the following tests to verify tha...

Page 21: ...tching the pump on Channel 1 and the program selected will be displayed on the screen During the self test a long beep will be heard This procedure verifies that the pump s acoustic and visual features are working properly After overview press Start Ok key to display the last set rate If air sensor is off Press to confirm 5 Press to prime the IV line Warning Ensure the set is not connected to a pa...

Page 22: ...mp display will show the accumulation screen where all set data is shown check the settings if correct press to start operation 6 Disconnect the IV line from the IV bag or turn the drip chamber upside down to allow an air bubble greater than 5 mm to enter into the administration set 7 Air in line alarm will be activated as soon as the air bubble enters the set segment located behind the pump door ...

Page 23: ...listed below time is measured from actual occlusion time to alarm with accuracy of 30 20 500 ml h up to 20 seconds 60 ml hr up to 1 minute 1 ml hr up to 80 minutes 0 1 ml hr up to 11 hours NOTE The pressure threshold can be changed to suit patient need refer to section on changing the current Default Pressure Limit 10 Depending upon the set flow rate and pressure threshold the Down Occlusion alarm...

Page 24: ...ery Test 1 Insert an administration set in both channels and close both doors Press the doors until a click is heard in both channels NOTE For instructions on how to load and prime an administration set refer to sections Loading the Administration Set Priming the Line 2 Take the pump out of the charger 3 Press until the self test screen appears 4 The pump displays Channel 1 and the program selecte...

Page 25: ... 2 Verify that the CHARGE LED indicator in the charger right side above channel II is off 3 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 Warning Do not operate the BodyGuard 121 Twins Infusion system ...

Page 26: ...re each use Warning Air embolism can cause serious injury or death to the patient Do not connect a patient to the BodyGuard Infusion Pump until all trapped air has been cleared from the fluid path Carefully read the instruction for loading an administration set Punctured set components may cause air embolism as well Warning Drugs must not be administered to the epidural space unless the drugs are ...

Page 27: ...ection corresponds to the flow direction arrows inside the pump door 4 Insert the IV tubing into the pumping canal Insert the tubing from top down and avoid stretching or pulling the tubing 5 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 6 Close the pump door until the latch clicks Warning Use of any administrat...

Page 28: ...ys disconnect IV tubing from patient before starting priming procedure NOTE The priming flow rate is performed at a rate of 600 ml hr During priming the air in line alarm is disabled The priming volume is adjustable from 0 60 ml see Change set up section with an initial default setting at 20 ml Priming Operation before starting a program 1 Insert an administration set in Channel 1 and close the pu...

Page 29: ... instructions to prime the set once more until no air is left in the set Prime Operation After Air in Line Alarm 1 Press to mute the alarm 2 Disconnect IV tubing from patient 3 Press once Warning Ensure the set is not connected to the patient 4 Press to start priming You may stop priming at any time by pressing 5 The display screen will show a progress bar indicating the priming operation 6 When p...

Page 30: ...tration set into the pump s tubing canal Repeat same operation if necessary for channel 2 5 Turn on the BodyGuard 121 Twins pump by pressing key until the self test screen appears 6 The display will show Channel 1 and the program selected Press the key to display the last rate setting 7 Prime the administration set Warning Make sure patient is not connected to the pump during priming Repeat the sa...

Page 31: ...ng 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 Volume 0 1 to 99 9 ml in 0 1ml units 100 to 9999 ml in 1 ml units Concentration 0 1 to 1000 mg ml in 0 1 mg ml units Dose 0 1 to 1000 µg kg min...

Page 32: ...PCA applications Combines basal rate and pre programmed boluses Rate 0 0 to 100 ml hr in 0 1 ml increments Volume 0 1 to 1000 ml Bolus Volume 0 to 100 ml Bolus Rate 0 1 to 100 ml hr in 0 1 ml increments and 100 to 1200 ml hr in 1 ml increments 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 ...

Page 33: ... test screen appears and the screen will change to channel 1 and the set program Press to enter channel 1 and display the last set mode 2 When the Rate screen is displayed press twice 3 Scroll to Change set up option Press 4 Scroll to More and press 5 Enter code 901 using the numeric keyboard and press 6 Scroll to Select Program option Press 7 Scroll to the required program and press 8 Press to re...

Page 34: ...lude enough volume for the delay period in addition to the 5 ml KVO volume 1 Turn the pump on by pressing and holding the until the self test screen appears 2 Pump displays Channel 1 and the program selected Press Wait for the rate screen to display NOTE If pump is not already in Continuous program refer to changing program section for instructions on how to change the program NOTE Whenever you de...

Page 35: ...ming mode the pump will not recall the new value unless changes are confirmed by pressing within 10 seconds If prime procedure is activated during data setting the pump will return to the original previous screen once priming has completed Changing the Rate The pump allows rate adjusting during the Rate Over Volume Program To change the rate during the infusion 1 Use numeric keypad to enter the ne...

Page 36: ...ume over Time NOTE Before operating the pump in Volume Over Time make sure that you are in the Continuous Program and that the IV bag contains an additional 5 ml of volume to be infused This ensures adequate volume for KVO during End Program If Delay Before Start is set you must include enough volume for the delay period in addition to the 5 ml KVO volume To set Volume Over Time enable the time fu...

Page 37: ...et total time Do one of the following Press to confirm the existing parameters Enter the desired total time using the numeric keypad using the format HH MM for example enter 0 2 0 0 for two hours and press NOTE First two digits represent hours and last two digits represent minutes Use digital point to move from hours to minutes 12 The pump calculates the rate based on the time and volume entered t...

Page 38: ...en once priming has completed NOTE Whenever required to stop infusion press Stop displayed on screen Stop mode is limited for two minutes After two minutes alarm is sounded Press to mute The specific channel will show the rate on the charger s display Bolus During Continuous Operation The pump allows additional Bolus dose during Continuous operation 1 Press on 2 Set Bolus volume and press to start...

Page 39: ...e program will start to decrease the infusion rate according to the set taper down time Up and down time can be set to zero A TPN program with up and down time set to zero is a continuous program NOTE Before operating the pump in TPN program make sure that the IV bag contains an additional 5 ml to total volume to be infused This ensures adequate volume for KVO during End Program If Delay Before St...

Page 40: ...one of the following Press to confirm the existing parameters Enter the desired volume using the numeric keypad and press NOTE The screen will be blank upon initial setup 6 The screen displays the last set time total time for the program to run Press to confirm the existing parameters or enter the desired time using the numeric keys and press NOTE First two digits represent hours and last two digi...

Page 41: ... be interrupted early and the planned taper down time must commence immediately do as follows 1 During TPN program press Stop NO key the display will show STOP 2 Press continually 2 sec to stop the pump operation and display Taper Down screen 3 Do one of the following Press to start the taper down process immediately with the existing parameters Set time for taper down using numeric keys and press...

Page 42: ...alue is empty displays the original value or the previous screnn NOTE user may set TPN PROGRAMS on both channels Setting Down Occlusion 1 Turn the pump on by pressing and holding the until the self test screen appears 2 Pump displays channel 1 and the program selected Press Wait for the Rate screen to display 3 Press twice 4 Scroll to Change set up then press 5 Scroll to Pressure Level and press 6...

Page 43: ...he downstream occlusion is released When turning the pump on the pressure default will be recalled and not the pressure level After down stream occlusion infusion will restart from the stop point Program Delay The option to delay the program before start can be set in Continuous program TPN and 25 steps programs Turning the delay option ON 1 Press twice from STOP or settings mode 2 Scroll to Chang...

Page 44: ...usion will start automatically Dose Program The Dose program is the second program in the BodyGuard software behind the Continuous program Programming the pump using ml hr in Continuous mode is a standard default setting yet an operator is able to quickly select the Dose program in the event that this mode is desired The ability to program and adjust medication administration based on dose mcg kg ...

Page 45: ...next screen NOTE As a safety feature especially in pediatric care the pump can be configured to have a Flow Rate Limit option in the Adjust Settings menu The operator can set the rate so that under no circumstances can any infusion be programmed over 100 ml hr for example NOTE Volume is configurable from 0 1 to 9999 ml 0 1 increments to 99 9 ml and 1 ml increments from 100 to 9999 ml 4 After inser...

Page 46: ... For example the infusion below is running at 100 mcg kg min If the operator wishes to change to 200 mcg kg min he would press 200 and press Start OK within 10 seconds The second screen below would then be displayed Note that the pump displays the new dose and the new flow rate Before Change After Change 7 Bolus operation In order to program a bolus during the infusion perform the following steps ...

Page 47: ...mittent Infusion Optional The Intermittent Infusion program is a special program which enables the design of a dose delivery protocol at set intervals Each dose is given at a set time The pump will Keep Vein Open between the doses The infusion program continues until the total volume to be infused is delivered Rate over Volume 1 Turn the pump on by pressing and holding the until the Self Test scre...

Page 48: ...meters Enter the time between the each dose and press NOTE Interval time is counted from starting time of one bolus until starting time of the following bolus 7 KVO Rate Screen Do one of the following Press to confirm the existing parameters Enter desired KVO rate from 1 to 5 ml h press 8 Accumulation Screen Do one of the following Press to confirm the existing parameters and start infusion Press ...

Page 49: ...ing NOTE If prime procedure is activated during data setting the pump will return to the original previous screen once priming has completed NOTE Whenever required to stop infusion press Stop displays on the screen Stop mode is limited to two minutes After two minutes an audible alarm sounds Press again to mute the alarm or press STOP NO until the pump powers off Rate Adjustment It is necessary to...

Page 50: ...ed the operator has the following options 1 Resume Resume the original infusion exactly where it left off 2 New Bag Resume the original infusion with a new bag 3 Repeat Repeat or re program the infusion 1 Intermittent Stop Screen Press or to scroll to the appropriate selection and press 2 Resume New Bag Reprogram Screen Display shows a summary of the current infusion to be started User can scroll ...

Page 51: ...order to enable the air sensor Using the pump with air in line detector off may cause an embolism resulting in death or paralysis Switching the air detector off is not recommended and should be used only when absolutely necessary 3 Scroll to Change Set up option and press 4 Scroll to More and press 5 Enter Change Set up level 1 code using the numeric keyboard and press Volume Infused Review Set up...

Page 52: ...ly press to confirm the existing time and date and start infusion NOTE If the time and or date automatically displayed by the pump are incorrect go to the Settings Menu and select Set Time Date to reset the clock in the pump 1 Start Time Screen To change the Start Time type the desired start time using the numeric keypad and press To start pump immediately do not change the time and press NOTE To ...

Page 53: ...usion after one third of the interval time has elapsed the operator will not receive the remainder of the dose The pump will automatically begin KVO until the next scheduled dose The purpose of this One Third rule is to allow the operator to turn their pump off during a dose without changing the scheduled dose times If the pump is turned off during a dose and restarted after the next scheduled dos...

Page 54: ...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 death or paralysis Switching the air detector off is not recommended and should be used only when absolutely necessary 2 Pump displays program name NOTE If pump is not already in 25 Steps Protocol refer to changing program section for instructions NOTE Whene...

Page 55: ...tion the display identifies which step is currently running as well as the rate 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 NOTE Whenever required to stop infusion pre...

Page 56: ...fusions The menu organizes the infusion information centrally while maintaining the same programming format as the other infusion modes of the pump 1 Turn the pump on by pressing the until the Self Test screen appears 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...

Page 57: ...ration 5 Once the priming has completed the display will change back to the previous screen the pump was in before priming If more priming is needed repeat procedure Program Infusion 1 Volume Screen Enter the infusion Volume and press 2 Rate Screen Enter the Rate in ml hr and press or follow step 3 to change to concentration format 3 Rate Concentration Selection Screen To program Concentration in ...

Page 58: ...en The lock time is the amount of time between patient boluses Do one of the following Press to confirm the existing parameters Enter the desired lock time in minutes and press 8 Limit in XXX Hours To enable this feature go to the Change Set up menu and set a time limit window then press In the following screen choose either the amount of max Dose at Time Window or the max Boluses Number during th...

Page 59: ...battery power NOTE The BodyGuard is capable of continuous infusion basal rates of up to 100 ml h However you may use the pump for the delivery of only one drug protocol and the maximum safe ceiling for this regime could be for example 30ml h operators can set a maximum rate in Change Set Up using the Technician Access Code to assure other operators do not accidentally program the pump to deliver a...

Page 60: ...ump is not connected to the mains charger Operator can check the charge level by monitoring the black fill inside the symbol i e completely black symbol indicates a fully charged battery Patient Activated Bolus A PCA infusion can optionally be programmed to allow the patient to request boluses of a specified volume within predetermined time intervals The patient can request the bolus by one of the...

Page 61: ...re 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 To change go to Program Infusion in the PCA menu and follow the steps until the selection can be made for ml mg or µg 4 The display screen will show a bar indicating the Bolus is being infused The progress bar displays the...

Page 62: ... of the bolus to be infused clear and the amount infused dark Once the bolus is completed the pump will resume the original PCA infusion operator can stop bolus at any time by pressing End of Infusion Restart Infusion or Bag Change 1 End Infusion Screen Once infusion has reached its end pre set volume was infused an alarm sounds and the display will show 2 KVO Display The alarm will stop after 4 b...

Page 63: ...Menu When asked for a code enter the Unlock Code 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 If using an ambulatory IV PCA or Epidural set without a drip chamber priming the line may be needed Disconnect the set from patient before priming Return to PCA Programming Scre...

Page 64: ...am is turned ON The keys are locked in memory until they are unlocked or until entering Change set up mode To unlock the keys Press and hold until the entire graph is cleared and a beep is heard The beep indicates that the locking program is OFF The number one is no longer displayed in the upper right corner of the screen and the keys are unlocked Level 2 Maximal Rate locking 1 Press twice from ST...

Page 65: ...ograms Battery Status 3 TPN Program Status in a graphic illustration 3 Continuous Dose PCA Time remaining for the end of the program 3 25 Steps Time and Date 4 Cont TPN Dose PCA Time and Date 4 25 Steps Actual Pressure Actual Pressure 5 Cont TPN Dose PCA Actual Pressure Actual Pressure Pressing during data setting or in the stop mode will display the following Infused 500 ml 1000 Battery Level Bat...

Page 66: ...ess Start OK and follow instruction in View set up section NOTE If no selection is made within ten seconds after pressing the screen will exit the information mode and display the previous screen To exit the information mode after making a selection in Review set up press once to return to the original screen To exit the information mode after making a selection in Change set up press Depending on...

Page 67: ...pty Full 2 Display Time and Date Time and date 3 Show Power Voltage Battery and power specifications 4 Buzzer Level Current buzzer volume setting 5 Pressure Level Current pressure level setting 6 Pressure Defaults Current pressure default setting 7 Select Program Current Slected Program 8 Volume Option Option currently ON or OFF 9 Priming Volume Current Priming volume setting 10 Priming Rate Curre...

Page 68: ... or OFF 20 Language Current pump messages language 21 Serial Number Pump Serial Number 22 Production Date Pump production date 23 Operation time Hours since last Service Calibration 24 Software Version Pump Software Version 25 Volume Calibration Volumetric Calibration value 26 Pressure Delta Pressure Calibration Delta value 27 Pressure CAP Pressure Calibration Cap value 28 EXIT EXIT ...

Page 69: ... Make adjustment by pressing or and press To adjust other parameters 1 Scroll to select More and press 2 Use numeric keypad to enter Code 901 and press 3 Scroll to select a desired parameter and press 4 Adjust the parameter by pressing or or by using the numeric keypad 5 Press and the screen displays Restart Pump 6 Press to continue Volume Infused Review set up Change set up Buzzer Level More Chan...

Page 70: ...stops or changes the it 7 Priming Volume Set the priming volume from 0 60 ml 8 Priming Rate Optimal 600ml h adjustable up to 1200ml h 9 Max Bolus Volume Set the Max bolus volume from 0 100 ml 10 BOLUS rate Set the bolus rate from 0 1200 ml hr 11 Maximal Rate Set the maximal rate from 0 1 1200 ml hr 12 KVO rate Set the KVO rate from 0 1 5 0 ml hr 13 PCA Limit Setting Set a time window in which a li...

Page 71: ...n NOTE While the pump is in programmable mode all parameters can be set or parameters used in last program can be confirmed The memory hold capability is available for the life of the internal battery 5 Alarm State and Troubleshooting Alarm State When the infusion pump detects a problem the following occurs The infusion stops An audible alarm sounds A message appears on the display screen indicati...

Page 72: ...Infusion stops and an alarm is activated The operation led for the relevant channel will blink red The charger display will show PRES for Pressure The roller or clip on the administration set is closed downstream of the pump Administration set is kinked Cannula is blocked Administration set loaded incorrectly NOTE operator may change pressure setting Open clamp clip Straighten the Set Change or cl...

Page 73: ...led for the relevant channel will blink red Fatal internal error has occurred Restart the pump If the alarm does not stop press Info and record the error number if possible Pack the pump properly in its original packaging and contact your service provider End Program Program ends pump will start KVO mode automatically if enabled in settings menu The operation led for the relevant channel will blin...

Page 74: ...peration led for the relevant channel will blink red Lock mode is turned on No action required If changing parameters is required unlock the keys using Info button refer to lock section for further instructions Wrong TPN data Program will not start operating The operation led for the relevant channel will blink red The set parameters are impossible to perform Volume or time parameters are incorrec...

Page 75: ...curacy 5 KVO rate 0 1 to 5 ml hr to be set Air Sensor Ultrasonic adjustable air bubble size Maximum Pressure 0 7 bar or 10 psi Adjustable high normal low Power Supply 110 240 VAC 50 60 Hz 0 3A max Battery Rechargeable Li ion Polymer 7 4V 1800mAh Typical Battery Operation at 125 ml hr 7 5 hours Battery Charging Automatic when clicked into the Charger that is connected to an AC power source Four hou...

Page 76: ...he BodyGuard displays the following alarms Air in line Down Occlusion Pump Unattended End Program Low Battery End Battery Door Open Fatal Error Lock Mode Lock Out Mode Missing Key NOTE When this symbol is seen consult accompanying documents ...

Page 77: ...nufacture in accordance to ISO 13485 CE marked In accordance with the Medical Devices Directive 93 42 EEC EMC The BodyGuard Infusion System is designed to be in compliance with EN 60601 1 safety and IEC 601 1 2 EMC Environmental Specifications Non Operating Conditions Transportation and Storage Temperature 25 o C to 50 o C 13 o F to 122 o F Humidity 5 to 100 R H non condensing Air pressure 48kPa t...

Page 78: ...78 Accessories optional Bolus cable Charging cable Small bag Large back bag ...

Page 79: ...er with chemicals such as Xylene Acetone or similar solvents These chemicals can cause damage to plastic components and paint Use a lint free cloth dampened with warm water and a mild detergent or disinfectant Caution Do not soak or immerse any part of the pump or charger in water Storage If the pump is to be stored for an extended period it should be cleaned and the battery fully charged Store in...

Page 80: ...use click the pump into the Charger and plug the system into an AC wall outlet if possible to charge battery 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 a discharged state for a long period of time may damage the battery Note Whenever ...

Page 81: ...the purchaser s responsibility Material returned to CME or its designated representative should be properly packaged using CME shipping cartons and inserts Inadequate packaging may result in severe pump damage This Limited Warranty shall not apply to defects or damage caused wholly or in part by negligence spilt fluids dropping of the pump misuse abuse improper installation or alteration by anyone...

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