Home
CME BodyGuard 323 - User manual
Contents
1. 2 Buzzer Level Adjust the buzzer level 3 Technician code level two Lock Out Turn lock out ON OFF 4 Technician code level one Restart pump Restart pump 5 Pressure Defa lt Select pressure default High 21 psi Normal 14 psi Low 7 psi 6 Select Program Select the infusion program 7 Priming Volume Set the priming volume from 0 60 ml 8 Max Bolus Volume Set the Max bolus volume from 0 100 9 Bolus Rate Set the bolus rate from 0 1200 ml hr 10 Maximal Rate Set the max rate from 0 1 1200 ml hr 11 KVO rate Set the KVO rate from 0 1 5 0 ml hr 12 Flow Control 0 20 drops per ml 13 Air bubble size Set detectable size from OFF to 1 0 ml Turn on to clear all program parameters upon system shut off Turn off to save all 14 Store last program program parameters upon system shut off 15 Operation LED Turn operation LED ON OFF Turn time option ON OFF While time 16 Tim option option is ON Continuous Intermittent P and 25 Steps program will be set to Volume over Time 17 Delay before start Turn option ON OFF Enable changing the language of pump 18 Language messages only for models in which the Software includes more than one language 19 Time Date Set actual time and date 20 History Indicates injection history cg NOTE while the pump is in programmable mode all parameters can be set and parameters used in last program can be confirmed The memory retention capability is available for the life
2. 4 Dose Volume Screen Ro EIN e Press to confirm the existing parameters e Enter the Dose Volume and press Can 5 Dose Rate Screen Do one of the following e Press to confirm the existing parameters e Enter the Dose Rate and press CH BodyGuard Operator Manual 41 4 Operation Intermittent Infusion 6 Interval Time Screen Do one of the following e Press CH to confirm the existing parameters e Enter the time between the start of 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 e Press to confirm the existing parameters e Enter the desired KVO rate from 0 1 to 5 ml h and press CD 8 Accumulation Screen Do one of the following e Press to confirm the existing parameters and start infusion e Press M go back and adjust program parameters c 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 Eu Press to Start Infusion 10 During program operation the pump displays the rate in which the program is operating ee 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 CD y gt NOTE If prime procedure is activated during data setting the pump will r
3. BodyGuard 323 Infusion Pump System Operator Manual C Es Manufacturer Caesarea Medical Electronics Ltd European address Staufenburgstr 23 Lichtenstein P O B 1248 T Lichtenstein 72805 Germany dem International Toll Free 800 323 575 00 www cme infusion com Contact e mail Sales cme infusion com EDITION July 2009 Ref 100 090X e NOTE To assure proper use of the BodyGuard Caesarea Medical Electronics Ltd urges all users to read this manual carefully become familiar with the procedures and system functions and follow all recommendations N 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 Please contact your technician in order to enable the air sensor if disabled with no need 1 U S A federal law restricts this device to sale by or on the order of a physician BodyGuard Operator Manual 2 Table of Contents 1 Introduction an 5 OVETVIEW A 5 Button Descriptions and Functions uuuussssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 5 BodyGuard Pump with Door Open nnnnnnnnnnnnnnnn 8 The Chatger ceoooeesseescieDeDeesseppeepDeHUPHPDI ODE 9 System Safety Ch cks tester ee 10 Pump ACCUFdCY iiec cce isses sees
4. Overview The BodyGuard System provides the following features e Small light and compact pump e Multiple Programs Highly accurate fluid delivery Quiet operation mounted on an IV pole e AEA Suitable to be used in ambulances BodyGuard Operator Manual Operated with a custom safe administration set Used for ambulatory care in a carrying pouch or 1 Introduction Infusion Rate 0 1 to 1200 ml hr Volume 0 1 to 99 9 ml in 0 1ml increments or 1 to 9999 ml in 1ml increments Secondary Infusion Piggy programmable with the same infusion rate and volume capabilities as the primary continuous infusion A set dose delivered in set intervals Between Intervals the pump will keep vain open KVO Mode Total Parenteral Nutrition Rate Taper program with programmable up and down times Patient Control Analgesia Continuous delivery plus or programmed boluses Bolus Volume 0 25 5 ml Clinician Bolus Volume 0 1 100ml Bolus Rate 0 1 1200 ml h Operator can design a specific protocol for drug delivery which contains up to 25 steps Infusion Rate 0 1 to 1200 ml hr Volume up to 9999ml for each step Accumulated Volume for all steps up to 10 liters Rechargeable internal lithium ion battery or alkaline 2X9V batteries Battery charged in a pole mount charging cradle or with an A C adaptor Free flow protection valve standard on every CME administration set 1 Introduction Front of BodyGuard Infusion P
5. Enter time for taper down using the numeric keys and press to start the taper down process Taper down time should be lower than the ongoing taper down time 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 CH NOTE If prime procedure is activated during data setting the pump will return to the original previous screen once priming is completed NOTE Whenever required to stop infusion press Cu Stop displays on the screen Stop mode is limited for two minutes After two minutes an audible alarm is sounded Press again to mute the alarm NOTE During programming you may backspace by using gt Pressing Once clears the last entered digit Pressing again clears the next number 90 Pressing when the value is empty displays the original value or the previous screen Resume or Repeat Infusion 1 When the pump is turned OFF during infusion this screen will appear when the pump is turned back ON Do one of the following Resume To resume this program exactly where it stopped press Cu The accumulation screen is displayed The volume remaining will be infused Repeat To restart the program at the beginning and or to set new parameters press CD and follow the instructions on the pump BodyGuard Operator Manual 52 4 Operation PCA infusion PCA Infusion Patient Control Analgesia is a program used f
6. Press Cu 3 Scroll to More and press Cu 4 Enter Change Set up Level 2 code using the numeric keyboard and press Cu BodyGuard Operator Manual 65 5 q C 1 2 Press Q or A to change from OFF to ON and press to approve NOTE The default setting is OFF NOTE Unlock using the same procedure Maximal Rate locking Press O twice from STOP or setting mode Scroll to Change Set up option Press CH Scroll to More and press Cu Enter Change Set up Level 1 code using the numeric keyboard and press Scroll to Maximal Rate option and press Cu Use numeric keys to set desired rate and press Cu BodyGuard Operator Manual 4 Operation Info Mode 4 Operation 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 One All programs Infused Volume Infused Total Volume to Be Infused HEN 1 500 ml 1000 Two All programs Battery Status Battery Level Battery time 5 48 Three Continuous Tubing Temperature Intermittent Three PCA Boluses History for current P Bo oluses program C Attempted 3 Given 1 A Delay 60Min Four Continuous Time remaining for the end Intermittent of the program Time Left 1 00 Four TPN Program Status i
7. Whenever you decide to set a new program follow instructions at the bottom of screen e NOTE The screen will be blank upon initial setup When returning to a program the screen will display the last set program 3 Rate Screen Do one of the following y e Press to confirm the existing parameters e Enter the desired Rate and press 4 Volume Screen Do one of the following y e Press to confirm the existing parameters e Enter the desired Volume and press CH 5 Accumulation Screen Do one of the following y e Press start infusion to confirm the existing parameters and E e Press to go back to Rate screen Bu Press 3 to Start Infusion BodyGuard Operator Manual 36 4 Operation Continuous Infusion 7 During program operation the pump displays the rate in which the program is operating e 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 Cae NOTE If prime procedure is activated during data setting the pump will return to the original previous screen once priming is completed Rate Titration The pump allows rate titration during the Rate Over Volume Program To change the rate during the infusion 1 Use numeric keypad to enter the new desired rate during operation and press D within five seconds The pump will briefly alarm and the infusion will resume at the adjus
8. line with the flow direction arrows inside the pump door 4 Insert the IV tubing into the pump by placing the key into the keyway as shown by the arrow in diagram 1 Insert the tubing from left to right with the shorter end connected to the medication bag on the left and avoid stretching or pulling the tubing Check that the key located on the tube is located in its correct position in the tubing guide 9 NOTE The IV key can only be fitted into the key space one way If you are having trouble fitting it do not force it in Try to turn the line around to ensure you have correctly lined up with the direction of flow Locate the Anti Stretch locator in the round space on the left side Verify that the distal flow valve is on the right hand side of the pump Close the pump door until the catch clicks a noo NOTE Ensure that the tubing is inserted completely into the pumping channel Warning Use aseptic technique Patient infection may result from the use of non sterile components Maintain sterility of all disposable components and use only once single use consumables marked BodyGuard Operator Manual 29 4 Operation Priming the Line NOTE The BodySet administration set contains a one way check valve Therefore the lines cannot be primed using gravity and must be primed either using the BodyGuard pump priming function or by pressing on the manual priming valve In case manual priming is required use an administration s
9. the manufacture s package insert accompanying the drugs Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient N Warning For epidural administration of drugs use BodySet microbore with yellow stripes N onthe tubing N Caution Component damage may occur if not installed properly Assure all connections X are secure do not overtighten This will help minimize leaks disconnection and component damage BodyGuard Operator Manual 2 4 Operation The BodySet Macrobore Luer Female Cap Keeps the set sterile Connects the administration set to solution bag Slide Clamp Can be used to occlude the tube Locates the tube in the correct flow direction Administration Tubing PVC 3 x 4 1 mm Transfers the solution 6 Y Connector Used to add drugs by syringe BodyValve With Cap Anti free flow valve 8 Valve Cap Keeps the set sterile BodyGuardOperatorManual 9G 4 Operation BodySet Macrobore with Drip Chamber Function Spike With Cap Connects the administration set to solution bag 2 Drip Chamber Displays infused drops from administration bag to the patient Slide Clamp Can be used to occlude the tube Locates the tube in the correct flow direction Administration Tubing 3 x 4 1 mm Transfers the solution BodyValve With Cap Anti free flow valve The set can be configured without the Y connector BodyGuard Operator Manual 27 4 Operat
10. 1 i oo 4 Operation 25 Steps Protocol O After entering the last required step press without entering a rate This indicates that all data required for the protocol has been set All programs following the last set program will be automatically cleared Sa NOTE If pump is in Delay Mode enter KVO rate T Accumulation Screen Do one of the following e Press to confirm the existing parameters e Press 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 Eu Press gt to Start Infusion to go back to rate setting screen 9 During program operation the display identifies which step is currently running and the rate e 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 CD If prime procedure is activated during data setting the pump will return to the original previous screen once priming is completed P gt NOTE Whenever required to stop infusion press Stop displays on the screen Stop mode is limited for two minutes After two minutes an audible alarm is sounded Press E again to mute the alarm e NOTE During programming you may backspace by using Ge Pressing gt once clears the last entered digit Pressing gt again clears the next number Pressing when the value
11. Loading the Administration Set amp Priming the Line 2 Press e until the Self Test screen appears If air sensor is off press to confirm Please contact your technician in order to enable the air sensor if disabled with no need 3 The pump displays the program selected and its status The display will automatically change to display the last rate setting 4 Change the infusion mode to Continuous See Change Set up Section for instructions Set the infusion rate at 500ml hr using the Numeric keypad and press Cu 5 Set Volume at 20 ml press to start operation 6 Open the pump door T Door Open alarm will be activated at once 8 Close the door and press Cu BodyGuard Operator Manual 4 Operation Battery Test 1 Insert a BodySet in the pump and close the door Press the door until a click is heard gg NOTE For instructions on how to load and prime an administration set refer to sections Loading the Administration Set amp Priming the Line 2 Take the pump out of the charger 3 Press e until the Self Test screen appears If air sensor is off press to confirm Please contact your technician in order to enable the air sensor if disabled with no need 4 The pump displays the program selected and its status The display will automatically change to display the last rate setting 5 Change the infusion mode to Continuous See Change Set up Section for instructions Set the infusion ra
12. aana aaea aane ues LE is eue 11 2 Symbols Warnings and CautionS cccccccccccccccccccccnnncnnnnnnnnnnnininnn 15 System SYMDOlS ec 15 Terms Used In Manual cccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeseeeeeees 16 o deut UNUM adhe IE IM DI IEEE LII D CIE 16 WarTIlligS siii 16 A M HR 18 3 Installation and Set UP oooooocccccccccccccccocccccnonnncncnonnnonnnnnnnnnnnnnnnnnnnnnnnnnn 19 Uripacking Beaters age arte moe ee i ED DL DL D LIRE 19 Charging the Pump sis 20 4 Operation arena o aed AE Ia a ed 21 Before Operating the Pump ccccooonnnnnnncccncncncnonannnnnnnncnnnnnnnananannnnennnnnns 21 Pump Operation Test cn 21 Air in Line Alarm Test eeeeeeeeeeesesseeeeeene nennen 22 Down Occlusion Alarm Test cccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 22 Door Open Alarm Test uuseeeeeeesseseeeeeeeen nennen 23 Battery Testi 24 Charger Indicator Test Leere 24 Dedicated BodyGuard Administration Sets 25 The BouyValve oet eee atte 25 Loading the Administration Set nennen nenn 29 Priming Ihe LO ascot ee see Stet e er ihre 30 Prime In Continuous Intermittent TPN and 25 Steps Modes 30 Prime In PCA Made a na 31 Prime Operation After Air In Line Alarm 32 Manual Prime OperatiON cccccccconnnnncncnnccc
13. allow the user to turn their pump off during a dose without changing the scheduled dose times If the pump is turned off during a dose and not restarted until after the next scheduled does was scheduled then the pump will start the next dose immediately followed by a complete interval For example if the patient restarts the infusion an hour past the scheduled dose time then will receive a complete dose followed by a complete interval If the pump is turned off during the interval period the patient can restart the pump anytime before the next scheduled dose without impacting the timing of the delivery of the next dose If the pump is not restarted until after the next scheduled does was scheduled then the pump will start the next dose immediately followed by a complete interval BodyGuard Operator Manual 47 4 Operation 25 Steps Protocol 25 Steps Protocol 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 Se IN BodyGuard Operator Manual NOTE Before operating the pump in 25 Steps Protocol make sure that the IV bag contains an additional 5 ml of total 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
14. and Volume Infused Hour by Hour for the Last 24 Hours use the arrow keys to navigate through the hours e Chart of Bolus Delivery During the Last 24 Hours Hour by Hour e Chart of Volume Including Boluses Delivered During the Last 24 Hours Hour by Hour NOTE press CD to resume infusion when you return to the STOP screen Events Log To access the history of events you need to access Change Set Up using the Level 1 Technician Access Code The events history carries the last 500 user events i e changes to programs pump started stopped etc and the status of the pump i e battery charge pressure levels etc It is not patient specific i e the 500 events are likely to span multiple patients recently treated with that particular pump To access the events history 1 From the main menu scroll to Change Set up and ress ED 2 From the main menu scroll to More and press CH 3 Enter the Level 1 Technician Access Code and press CH 4 Scroll down to History and press 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 This means there have been 754 events in this pumps life and events 255 754 are stored in this history The pump deletes the oldest event in the log each time a new e
15. of the internal battery BodyGuard Operator Manual 5 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 and The LED indicator will change from green to red NOTE Pressing E during an alarm mutes the alarm for two minutes BodyGuardOperatorManual A 5 Alarm conditions and troubleshooting Troubleshooting Description Result Possible Cause Required Action Air in Line Infusion stops Air is present in administration Disconnect line from patient press Air in Line Press Stop to mute and an alarm is activated Set The roller or clip on the administration set is closed upstream of the pump The line was not loaded correctly STOP NO Remove the air as described on priming section Open clamp clip Re load the IV line Down Occlusion Down Occlusion Infusion stops and an alarm is The roller or clip on the administration set is closed Open clamp clip Press Start key programming activated downstream of the pump Press Stopio MUIE Administration set is kinked Straighten the set Cannula is blocked Change the Cannula Administration set loaded Re load the IV line incorrectly NOTE Operator may change Refer to Setting Down Occlusion
16. paralysis Switching the air detector off is not recommended and should be used only amp when absolutely necessary Please contact your technician in order to enable the air sensor if disabled with no need The BodyValve The Anti Free Flow valve BodyValve enhances pump functioning by e Preventing free flow in the event the set is detached from the pump e Preventing back flow reflux in the event several infusion pumps are connected simultaneously to the same patient e Preventing free flow in the event of a mechanical malfunction e Preventing pump operation if the set has been loaded incorrectly N Warning Replace the administration set every 72 hours to lessen the incidence of bacteria X formation N Warning Disposables must be compatible with the medicine delivered N Warning Patient or operator injury may result if package is opened or damaged or if X damaged components are used Visually inspect contents and package before each use Warning Air embolization can cause death or serious injury to the patient Do not connect X a patient to the BodyGuard Infusion Pump until all trapped air has been cleared from the fluid path Carefully read the instructions for loading Puncturing set components may cause air embolism Warning Drugs must not be administered to the epidural space unless the drugs are indicated for this purpose and are administered in accordance with the indications included in
17. patient when the IV line is not attached to the pump When the pump is attached to the IV line and delivering fluid the pressure delivered by the pump opens the valve The valve is also one way valve preventing fluids flow from the patient to the administration line Air in Line Accumulation To improve the detection of air in the IV line the BodyGuard 323 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 over any 15 minutes period This limit is not configurable Although an individual bubble may not exceed the pre programmed threshold if the cumulative volume of smaller bubbles exceeds 1ml over a period of 15 minutes an air in line alarm is initiated This accumulation feature is particularly useful with infusions or patients who are highly sensitive to air i e infants neonates children or when infusing products that create significant volumes of small air bubbles Anti Bolus Function The anti bolus function is designed to reduce the bolus that may occur upon the release of an occlusion following a downstream occlusion alarm Upon the detection of a downstream occlusion the alarm is activated and the pump returns the IV line pressure to neutral within 15 seconds Neutral line pressure is achieved by the reverse operation of the pumping mechanism and measur
18. pressure setting section Pump Unattended An alarm is Two minutes has elapsed Press START OK to resume Pump Unattended activated without a button press during Door Open Close Door Infusion stops and an alarm is activated The door of the pump was not closed prior to operation The door has accidentally opened during operation Close the door of the pump Send the pump for service Low Battery Low Battery Connect To Charger Pump will only run for another 30 minutes if it is not connected to mains 30 Minutes of battery life are remaining Place the pump connect to mains End Battery End Battery Connect To Charger Pump operation stops The pump cannot be used before being connected to mains BodyGuard Operator Manual Battery is depleted Place the pump before operating 73 in charger and in charger and connect to mains Wait 2 minutes Description Fatal Error Error xx number Send for service Result Infusion stops 5 Alarm conditions and troubleshooting Possible Cause Fatal internal error has occurred Required Action Restart the pump If the alarm does not stop pack the pump properly in its original packaging and send it for service End Program End Program Press stop to mute Program ends pump will turn to KVO mode Current infusion program has been completed Press STOP NO to restart a new
19. program or turn the pump OFF Missing Key Missing Key Set key amp Close Door Pump will not start Administration set loaded incorrectly the key was not located in its place correctly A set different than the Bodyset Microset was loaded in the pump Reload the set into the pump as pen the instructions Change the set to a BodySet Microset and load it according to instructions Lock Out Setting cannot be Lock Out mode is turned on No action required If changing changed program is required unlock the pump and refer to lock section for further Locked instructions Lock mode Setting keys do Lock Out mode is turned on No action required If changing not function parameters is required unlock the keys and refer to lock section for Lock Mode 1 further instructions Wrong TPN data Wrong TPN data Check Data Program will not start operating The set parameters are impossible to perform Volume or time parameters are incorrect Check data and change accordingly BodyGuard Operator Manual 74 6 Specifications 6 Specifications Pumping Mechanism Flow Rate Priming Rate Total Infused Volume Total Time Setting Accuracy KVO rate Air Sensor Maximum Pressure Power Supply Battery Battery Operation at 125 ml hr Battery Charging Alarms e NOTE x j X BodyGuard Operator Manual Piston Pump PCA 0 to 100 ml h
20. 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 amp Priming the Line Press e until the Self Test Screen appears If air sensor is off press to confirm Please contact your technician in order to enable the air sensor if disabled with no need The pump displays the program selected and its status The display will automatically change to display the last rate setting Change the infusion mode to Continuous See Change Set up Section for instructions Set the wap rate at confirm setting Set Volume at 20 ml and press to start operation 500ml hr using the Numeric keypad and press GD DE Insert air into the IV line to allow an air bubble greater than 10 mm to enter into the administration set Air in line alarm will be activated as soon as the air bubble enters the set segment located behind the pump door Press gt to turn the alarm off Down Occlusion Alarm Test N Insert a BodySet into the pump and close the door Press the door until a click is heard Make sure room temperature is 21 23 C NOTE For instructions on how to load and prime an administration set refer to sections Loading the Administration Set amp Priming the Line Press e until the Self Test screen appears If air sensor is off press to confirm Please contact your technician in order to enable the air sensor if disa
21. 44 46 53 55 57 62 66 68 70 71 Start new Bag 45 STOP NO 6 65 68 74 75 T Time Delay 46 Time option 38 44 46 70 72 Total Infused Volume 76 TPN Program 34 50 U Up Arrow 6 V Valve 5 10 25 28 29 30 76 Volume Over Time34 38 44 72 Ww Warnings 15 16 80
22. 5 36 41 46 48 50 53 64 Alarm 6 7 8 10 17 21 23 30 32 34 37 39 42 43 49 52 60 72 75 B Battery 5 17 20 24 57 62 63 67 69 71 73 75 78 Bolus 5 7 17 19 31 34 53 59 61 62 66 67 69 71 C Cautions 15 16 18 Changing the Program 35 Changing fluid container 45 60 Charger 9 16 21 24 33 57 72 74 76 77 Charging the Pump 20 D Delay Program 42 45 46 49 51 Display screen 6 7 21 30 32 54 57 59 72 Down Occlusion 22 23 64 73 75 E Early Taper Down 52 End Program 34 38 48 50 75 76 F Fatal Error 75 76 Flow Direction 8 28 29 Flow Rate 11 23 25 30 75 Free Flow Protection 5 10 25 H History 53 58 62 67 71 I Info 7 16 42 45 49 51 53 58 61 63 64 65 67 68 69 71 Infused Volume 67 68 75 Intended Use 16 Intermittent Program 34 41 43 IV pole 5 17 33 K Keep Vein Open Mode 34 Keypad Locking 8 29 Keyway 8 29 KVO rate 34 42 45 49 51 70 72 76 BodyGuard Operator Manual L Lock Mode 36 41 65 73 74 Lock Out 36 41 48 50 61 65 70 71 74 75 M Maximal Rate Locking 65 66 Missing Key 74 75 N Numeric Keys 7 22 24 35 37 39 43 44 46 47 52 65 66 70 0 Operating Conditions 76 Operation LED 7 38 44 69 71 P PCA Program 7 17 34 53 56 63 Power Supply 75 78 Pressure Level 62 64 69 71 Priming 6 7 21 24 30 33 35 37 39 42 49 52 54 58 60 69 71 73 75 76 R Rate Over Volume 34 36 37 41 Rate Titration 37 43 55 S Safe Container 58 Select Program 35 54 64 70 74 Service 1 16 17 70 75 78 80 Set up 19 22 24 35 38
23. KVO volume Turn the pump on by pressing and holding the e until the Self Test screen appears Warning If air sensor is OFF please contact your technician in order to enable the air sensor if disabled 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 Pump displays program name and status The status is either Lock out or program for instruction regarding locking and unlocking the pump refer to locking section When the pump is unlocked press to continue e Z NOTE When pump is in Program mode all parameters can be adjusted When pump is in lock out mode parameters can be viewed but cannot be changed NOTE If pump is not already in 25 Steps Protocol refer to changing program section for instructions NOTE Whenever you decide to set a new program follow instructions at the bottom of screen NOTE The screen will be blank upon initial setup Rate Screen Step 1 Do one of the following e Press to confirm the existing parameters e Enter the desired rate and press Cu Volume Screen Step 1 Do one of the following e Press CH to confirm the existing parameters CD e Enter the desired volume and press Rate Screen Step 2 Pump displays the rate for step 2 Repeat directions as for step 1 and repeat until the required number of steps are entered D
24. air sensor if disabled with no need Read the entire Operation Manual before using the pump since the text includes important precautions The maximum volume that may be infused under SINGLE FAULT CONDITION is 0 1 ml 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 BodyGuard Operator Manual 16 2 Symbols Warnings and Cautions 75 Boluses will be infused up to the full volume that is requested unless the user stops the bolus IN manually by pressing ED This is true even when the volume infused is less than the specified Hour Limit for Volume e g 4 Hr Limit at the beginning of a bolus and goes over the limit during the bolus to complete it Make sure the pump is attached securely to the Charger which is connected firmly to an IV pole a A kinked or occluded IV line may impair the operation of the pump and the accuracy of the infusion Before operation verify that the IV line is not kinked or occluded The BodyGuard should be operated only with the Bodyset IV lines Use of IV lines other than the x Bodyset may impair the operation of the pump and the accuracy of an infusion Drugs must not be administ
25. ameters e Enter the desired hours for the limit and press CH 11 Hour Limit Screen 2 If an hour limit is entered in previous step the next step will propt user to enter the maximum amount of volume to be infused over that timeframe In the screen to the right 4 four was entered in the previous step for the hour limit Do one of the following Limit can be ml mg or ug depending on the program selected e Press to confirm the existing parameters e Enter the desired hours for the limit and press 12 Bag Volume Screen Do one of the following e Press to confirm the existing parameters e Enter the desired bolus volume and press CH 13 Locking Screen The pump automatically locks before a PCA infusion program can be completed Do one of the following e Press to lock the PCA program and proceed e Press to scroll through the programming again and review or adjust the program 14 Accumulation Screen The pump displays the accumulation screen with a summary the program entered User can scroll through the entire program by MAC or Do one of the following e Press to confirm parameters and proceed e Press to go back and adjust parameters nN BodyGuard Operator Manual 4 Operation PCA infusion es Press CO to start infusion cg NOTE User can confirm that pump is infusing by checking that the drips are displayed on the right side of the screen and that the LED light is blinking g
26. an the specified Hour Limit for Volume e g 4 Hr Limit at the beginning of a bolus and goes over the limit during the bolus To infuse a Clinician Activated Bolus during a PCA infusion perform the following steps 1 stop the current infusion and initiate the Clinician Bolus Enter Level 2 Technician Code and press ED 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 ug depending on the settings of the existing protocol entered for the PCA infusion The display screen will show a graph indicating the Bolus is being infused The graphical bar displays the amount 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 User can stop bolus at any time by pressing gt BodyGuard Operator Manual 59 4 Operation PCA infusion End of Infusion Restart Infusion or Bag Change 1 End Infusion Screen Once the infusion had reached an end pre set volume was infused an alarm sounds and display will show 2 KVO Display The alarm will stop after 4 beeps The pump will show the pre set KVO rat The alarm will sound again every 4 minutes until the user changes the bag or stops the pump 3 PCA Restart Menu This screen displays when 1 The pump is turned OFF and back ON in PCA mode 2 Infusion is
27. ation Test 1 5 Click the pump into a Charger connected to AC power Verify that the CHARGE CH indicator is on Red or Green light on charger 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 amp Priming the Line Press e until the Self Test screen appears If air sensor is off press to confirm The program selected and its status are displayed 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 self test is completed the display will show the last rate setting PRIME BOLUS Press to prime the IV line i Warning Ensure the set is not connected to a patient 6 Enter the Volume of fluid required to prime the set and press to begin priming procedure You may stop priming at any time by pressing The display screen will show a graph indicating the prime operation BodyGuard Operator Manual 01 4 Operation When priming is completed wait 2 minutes without pressing any key After two minutes the screen displays Pump Unattended and an alarm will sound Press Cu to silence the alarm again or t to exit alarm condition Air in Line Alarm Test 1 Insert a BodySet administration set and close the pump door Press
28. aution Do not soak or immerse any part of the pump or charger in water ZEN Storage If the pump is to be stored for an extended period it should be cleaned and the battery fully charged Store in a clean dry atmosphere at room temperature and if available employ the original packaging for protection Perform functional tests and ensure that battery is fully charged once every three months BodyGuard Operator Manual 77 7 Service and Maintenance Battery Operation The BodyGuard pump can operate on battery power which enables 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 standard battery provides 15 17 hours of operation at an infusion rate of 125 ml hr N Warning Do not operate the pump on AC power if the battery is not loaded in the pump 4 for back up r Note When the pump is not in 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 A Caution Leaving the battery in an uncharged state for a long period of time may damage X the battery r Note Whenever possible use the pump connected to an AC power supply via the charging unit This preserves the batter
29. ays the time for rate to taper up Press CH to confirm the existing parameters or enter the desired value from 00 00 to 04 15 hours Press CD T Down Time Screen The screen displays the time for rate to taper down Press CH to confirm the existing parameters or enter the desired value from 00 00 to 04 15 hours Press CH 8 KVO Rate Screen Do one of the following e Press to confirm the existing parameters e Enter the desired Interval Time and press 9 Accumulation Screen The pump calculates the set data and displays the accumulation screen with the maximal rate for the program to be infused during flat period Do one of the following e Press Can to confirm parameters and start infusion or enter delay time if applicable For further information regarding delay option refer to delay program section e Press Ce to go back to volume setting screen n Press e to start infusion 11 During program operation pump displays the rate in which the program is operating and program direction Up Flat Down BodyGuard Operator Manual 4 Operation T PN infusion Early Taper Down If the program must be interrupted early and the planned taper down time must commence immediately do as follows Press CD 2 seconds to stop the pump operation and display Taper Down screen Do one of the following Press CD to start the taper down process immediately with the existing parameters
30. be reviewed by scrolling the Info Menu See Using History Functions section of the manual Clinician Activated Bolus A Clinician Activated Bolus can be performed before starting the PCA infusion or during the PCA infusion To infuse a Clinician Activated Bolus before starting the PCA infusion perform the following steps T Selecting the Prime option from the PCA menu the screen will show the priming screen Select Clinician bolus option Enter Level 2 Technician Code and press CH i C amp D Enter the volume of the Clinician Bolus and press to begin priming procedure You may stop the bolus at any time by pressing C The Volume for the Bolus will be in ml mg or ug 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 ug 4 The display screen will show a graph indicating the Bolus is being infused The graphical bar displays the amount of the bolus to be infused clear and the amount infused dark E Once the bolus is completed the display will change back to the PCA menu BodyGuard Operator Manual SB User can stop bolus at any time by pressing CD 4 Operation PCA infusion Warning Boluses will be infused up to the full volume that is requested unless the user stops the bolus manually by pressing C This is true even when the volume infused is less th
31. bled with no need The pump displays the program selected and its status The display will automatically change to display the last rate setting BodyGuard Operator Manual 22 4 Operation 5 Change the infusion mode to Continuous See Change Set up Section for instructions Set the infusion rate at 500 ml hr using the Numeric keypad and press Cu 6 Set Volume at 20 ml and press to start operation T Wait 5 minutes and than connect a pressure gauge at a distance of 1 meter from the exit of the pump Place both the pump and the pressure gauge at the same level on a table 8 Wait another 5 minutes and occlude the IV line downstream of the pump between the pump and the pressure gauge 9 The Down Occlusion alarm occurs at the time and rates listed below time is measured from actual occlusion time to alarm with accuracy of 30 20 e 500 ml h up to 20 seconds e 60 ml hr up to 1 minute e 1 ml hr up to 80 minutes e 0 1 ml hr up to 11 hours cg 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 will be activated 11 Press E to mute the alarm Door Open Alarm Test 1 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
32. by pressing e until the Self Test screen appears If air sensor is off press y to confirm When the PCA menu displays select Prime and press to confirm Press OK to program priming procedure Enter the volume to prime the set and press to begin priming procedure You may stop priming at any time by pressing Cu The display screen will show a graph indicating the prime operation Once the priming is completed the display will change back to the previous screen the pump was in before priming If more priming is needed repeat procedure jj Make sure that all air is removed from the IV line before connecting to the patient BodyGuard Operator Manual 31 4 Operation Prime Operation After Air In Line Alarm 1 Press E to mute the alarm 2 Disconnect IV tubing from patient BOLUS Press once f l Warning Ensure the set is not connected to the patient i Cu Enter the volume to prime the set and press CH to begin priming procedure You may stop priming at any time by pressing gt 5 The display screen will show a graph indicating the prime operation 6 When priming is completed make certain that all air is removed from the IV line T Connect IV line to the patient and press to resume program Manual Prime Operation 1 In any case before operation or after air in line alarm a prime operation is needed the user can prime the set manually by using the manual priming valv
33. 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 and status The status is either Lock out or Program for instruction regarding locking and unlocking the pump refer to Lock Out section When pump unlocked press CD continue cg NOTE When pump is in Program mode all parameters can be adjusted When pump is in lock out mode parameters can be viewed but cannot be changed cg NOTE If pump is not already in TPN Program refer to changing program section for instructions E NOTE Whenever you decide to set a new program follow instructions at the bottom of screen 3 Bag Volume Screen Do one of the following e Press CD to confirm the existing parameters e Enter the desired volume and press D BodyGuard Operator Manual SN 4 Operation TPN infusion 4 Volume To Be Infused TBI Screen Do one of the following e Press to confirm the existing parameters e Enter the desired volume and press CH 5 Total Time Screen 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 and press CH cg NOTE First two digits represent hours and last two digits represent minutes for example enter 0 2 0 0 for 2 hours Use a point to move from hours to minutes 6 Up Time Screen The screen displ
34. d for the amount infused prior to turning off the pump To reset the volume use the numeric keypad to enter new volume Locked 1 When the pump is turned OFF in the middle of an infusion this screen will appear when the pump is turned back ON 2 Do one of the following e Resume To resume this program exactly where it stopped press Cu The accumulation screen is displayed The volume remaining will be infused e Repeat Torestart the program at the beginning and or to set new parameters press E and follow the instructions on the pump BodyGuard Operator Manual 8g 4 Operation Continuous Infusion Secondary Infusion PIGGY During Continuous Operation To perform a secondary infusion during Continuous operation complete the following steps PRIME 1 BOLUS Press once 2 Enter Secondary Infusion Rate and press Cu 3 Enter Secondary Infusion Volume and press lem 4 Pump will beep once and resume the Primary Infusion when the Secondary Infusion is completed NOTE User can stop the Secondary Infusion at any time by pressing and turning the pump off When the pump is turned back on the pump will resume the Primary Infusion NOTE User can titrate the Secondary Infusion with the same method that is used for a primary continuous infusion BodyGuard Operator Manual 40 4 Operation Intermittent Infusion Intermittent Infusion The Intermittent Infusion program is a special program which enabl
35. e if assembled in the administration set in use at that moment 2 Disconnect IV tubing from patient 3 Hold the tubing in a vertical position to maintain gravitation pressure Press the priming valve button continuously until all trapped air is primed Real ease the priming valve button to continue the anti free flow protection while infusing BodyGuardOperatorManual 8 4 Operation Operation steps The following are the steps for starting the infusion procedure For detailed instructions regarding each step refer to the relevant sections in the Operation chapter Pump Mounted on IV Pole 1 Connect the Bodyset to the medication bag Hang the bag on an IV pole 2 Click the pump into the Charger Mount the Charger on an IV pole 3 Connect the Charger via a standard power cord to a grounded AC outlet 4 Open the door of the pump and load the administration set into the pump s tubing guide 9 Turn on the BodyGuard Pump by pressing O the Self Test screen appears AN 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 death or paralysis Switching the air detector off is not recommended and should be used only when absolutely necessary 6 The program and status will appear on the display followed by the last rate setting T Prime the administration set N Warning Make sure patient is not c
36. ed infusion rate is lower than the KVO rate the KVO will run at the programmed infusion rate KVO during End Program is limited to a volume of 5 ml c NOTE To use the automatic KVO at the end of a protocol make sure that the IV bag contains overfill beyond the volume to be infused End Program When a protocol has completed an audible alarm will beep 4 times To stop the alarm and enter a new program press gt If the stop key is not pressed before the 4 beep have concluded KVO will begin when it is programmed to do so BodyGuard Operator Manual 34 4 Operation Changing Current Program Using Level 1 Code 1 Turn on the BodyGuard Pump by pressing the Self Test screen appears If air sensor is OFF please contact your technician in order to enable the air sensor if disabled 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 When a programming screen or infusion summary is displayed press twice d Scroll to Change Set up option Press Cu 4 Scroll to More and press Cu 5 Enter Change Set up Level 1 code using the numeric keyboard and press 6 Scroll down to Select Program option and press Cu E T Scroll to the required program and press 8 Press to restart the pump sI NOTE The selected program will remain in the pump s memory unti
37. ement of the IV line pressure through the in line pressure detection system BodyGuard Operator Manual 10 1 Introduction 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 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 Start up Graph at 1 ml h Initial Period Trumpet and Flow Rate With the BodyGuard 323 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 The accuracy of fluid delivery over various time periods is measured trumpet curves 2 The delay in onset of fluid flow when infusion commences start up curves Trumpet curves are named for their characteristic shape They display discrete data averaged over particular time periods or Observation windows not continuous data versus operating time Over long observation window
38. enu will display If the pump is locked the PCA Restart Menu will display See Restart Infusion section if pump is locked NOTE The PCA program automatically locks upon completion of programming NOTE If pump is not already in PCA Program refer to Changing Program section for instructions NOTE Whenever you decide to set a new program follow instructions at the bottom of screen PCA Menu Screen The user interface in PCA centers around the PCA menu From the PCA menu the user can select 4 3g i Prime Prime Administration Set Patient History ii Program Infusion Enter infusion details Review Set up Change Set up iii Clinician Bolus Infuse extra bolus iv Patient History View infusion history of patient v Review Set up View pump settings s i Change Set up Enables user to change pump settings and switch to other infusion modes Use m or to scroll through options Select the required option by pressing BodyGuardOperatorManual a 53 or 4 Operation PCA infusion Priming cg NOTE Priming is disabled during PCA operation Always prime the set before starting a program Warning Always disconnect IV tubing from patient before starting priming procedure 1 Selecting the Prime option from the PCA menu the screen will show the priming screen 2 Press OK to program priming procedure Warning Ensure the set is not connected to the patient i amp Enter the volu
39. er the desired volume using the numeric keypad and E press NOTE The screen will be blank upon initial setup Infusion Time Screen e Enter the desired total time using the numeric keypad for example enter 0 2 0 0 for two hours and press Cu NOTE First two digits represent hours and last two digits represent minutes Rate Screen The pump calculates the rate based on the time and volume entered and displays the rate on the screen Do one of the following e Press to confirm the existing parameters 96 e Press to go back to volume setting screen BodyGuard Operator Manual 3 oo 4 Operation Continuous Infusion 11 During program operation pump displays the rate at which the program is operating ee 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 CH i d NOTE If prime procedure is activated during data setting the pump will return to the original previous screen once priming is completed NOTE When required to stop infusion press gt Stop will be displayed on the screen Stop mode is limited for two minutes After two minutes alarm will sound Press gt to mute or Cu to continue Resume or Repeat Infusion Unlocked When the pump is restarted in Continuous mode and is not locked the pump will allow the user to confirm each of the parameters of the infusion The Volume will be adjuste
40. ered to the epidural space unless the drugs are indicated for this X purpose and are administered in accordance with the indications included in the manufacture s package Epidural 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 a BodyGuard Infusion System and or the accuracy of the infusion Any adjustments maintenance or repair of the uncovered pump or charger should be performed by authorized skilled technicians Any adjustments maintenance or repair of the uncovered pump or charger while connected to the power should be avoided Ix The BodyGuard Infusion System should be operated within a temperature range of 18 C 59 F to 45 C 113 F and up to 85 humidity Operating the pump at temperatures and or humidity other than within that range may affect accuracy Unsafe operation may result from using improper accessories Use only accessories and options designed for this system Disposables must be compatible with the medicine delivered N Battery charging is enabled as long as the charger cord is connected to the mains and the pump is in the charger Switching the pump off does not disconnect it from the mains To disconnect from mains remove the charger cord from mains To disconnect pump from mains re
41. es 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 Turn the pump ON by pressing and holding the until the Self Test screen appears If air sensor is OFF please contact your technician in order to enable the air sensor if disabled 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 and status The status is either Program or Locked for instruction regarding locking and unlocking the pump refer to lock mode section or If pump is unocked the Bag Volume screen will display after 2 seconds NOTE When pump is in Program mode all parameters can be adjusted When pump is in lock out mode parameters can be viewed but cannot be changed e NOTE If pump is not already in Intermittent Program refer to Changing Program section for instructions e NOTE Whenever you decide to set a new program follow instructions at the bottom of screen E NOTE When returning to a program the screen will display the last set program 3 Bag Volume Screen Do one of the following e Press to confirm the existing parameters e Enter the Bag Volume and press
42. et with special manual priming valve Prime function is used 1 2 Before starting a program After air in line alarm Warning Always disconnect IV tubing from patient before starting priming procedure Se NOTE The default priming flow rate is 600 ml hr During priming the air in line alarm is disabled Prime In Continuous Intermittent TPN and 25 Steps Modes se NOTE Access to the priming procedure in PCA mode is different from all other programs For detailed instructions refer to PCA Operation section Turn on the BodyGuard Pump by pressing e until the Self Test screen appears If air sensor is off press cs to confirm When the display screen shows the existing programmed PRIME BOLUS rate press once Warning Ensure the set is not connected to the patient 3 Enter the Volume of fluid required to prime the set and press CH to begin priming procedure You may stop priming at any time by pressing Ge The display screen will show a graph indicating the prime operation Once the priming is completed the display will change back to the previous screen the pump was in before priming If more priming is needed repeat procedure Make sure that all air is removed from the IV line before connecting to the patient BodyGuard Operator Manual 8 4 Operation Prime In PCA Mode Warning Ensure the set is not connected to the patient 4 Turn on the BodyGuard Pump
43. eturn to the original previous screen once priming is completed NOTE Whenever required to stop infusion press gt Stop displays on the screen Stop mode is limited for two minutes After two minutes an audible alarm is sounded Press gt again to mute the alarm BodyGuard Operator Manual 4 N 4 Operation Intermittent Infusion Rate Titration The pump allows rate titration during the Intermittent Program To change the rate during the infusion 1 2 Use numeric keypad to enter the new desired rate during operation and press Can within five seconds The pump will briefly alarm and the infusion will resume at the adjusted rate NOTE If pump is LOCKED the Level 1 technician code must be entered to confirm the rate change NOTE Rate titration is allowed only during dose delivery and not during KVO between doses NOTE If the rate change is not confirmed within ten seconds the pump will continue operation at the original rate and the display will return to the previous setting To stop the infusion press gt To change the rate while in Stop mode 1 2 3 Press any number on the keypad twice to return to the rate screen Adiust the rate and press CD Adjust all other parameters and press to restart infusion NOTE During programming you may backspace by using Cas Pressing C once clears the last entered digit Pressing ED again clears the next number Pressing 45 ien the value i
44. g parameters e Enter the desired rate or concentration and press D Rate Titration Limit Screen Enter the maximum rate of titration that can be used in the current protocol and press Rate can be ml h mg h or mcg h depending on program selected Bolus Screen Do one of the following Bolus can be ml mg or mcg depending on the program selected e Press to confirm the existing parameters e Enter the desired bolus dose and press Bolus Titration Limit Screen Enter the maximum bolus dose that can be used in the current protocol and press A Bolus dose can be ml h mg h or mcg h depending on program selected NOTE If the Maximum Bolus Dose screen does not appear on the pump during programming go to the Change Set up menu to activate Titration Bolus BodyGuard Operator Manual 55 4 Operation PCA infusion 9 Lock Time Screen The lock time is the amount of time between patient boluses Do one of the following e Press to confirm the existing parameters e Enter the desired lock time in minutes and press CH 10 Hour Limit Screen 1 As an additional safety precaution user can program a volume limit over a certain amount of hours User can set this limit for any amount of time between 1 One and 24 Twenty Four hours or can continue without setting a limit The default setting is OFF meaning there is no limit Do one of the following e Press to confirm the existing par
45. gs completely before operating the BodyGuard Infusion System Caution Indicates that the information is a caution Cautions advise you of circumstances that could result in damage to the device Read and understand this manual and all cautions completely before operating the BodyGuard Infusion System NOTE Indicates that the information that follows is additional important information or a tip that will help you operating the BodyGuard Infusion System Intended Use The BodyGuard 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 The system is intended for patients who require maintenance medications analgesics PCA therapy parenteral and enteral nutrition fluids chemotherapeutic agents and general fluids therapy in hospital and home care environments Warnings To avoid possible personal injury or loss of life observe the following 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 Please contact your technician in order to enable the
46. he new Bolus by entering the Level 1 Code The Bolus can be increased up to the Maximum Bolus Dose programmed into the specific infusion Changing Lock Out Time During The Infusion 1 Stop the infusion by pressing gt 2 Then press and hold gt until the screen appears allowing you to access the PCA Menu 3 Select Menu and enter the Level 2 code 4 Once in the PCA Menu select Program Infusion and follow the programming instructions to adjust the program Be sure to tell the pump that there is NOT a New Patient and the Bag Volume should NOT be reset BodyGuard Operator Manual 61 4 Operation Using History Functions The BodyGuard keeps a rolling 24 hour history of the current patient s infusion delivery This section addresses 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 While the pump is delivering medication pressing the O repeatedly will scroll through Volume Infused vs Volume to be Infused Battery Level Boluses Attempted Boluses Given amp Lock Time Review for the duration of the current delivery Program Review Screen Allows user to check current program parameters without having to stop the infusion Date amp Time e Actual Pressure Press E to stop infusion delivery and then press the button repeatedly to scroll through e Volume and Boluses Given in the Last 24 hours e Bolus Attempts Given
47. ing 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 other than qualified trained personnel or to damage resulting from inadequate packaging in shipping the pump to CME or its designated representative If after inspection CME or its designated representative is unable to identify a problem CME or its designated representative reserves the right to invoice purchaser for such inspection 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 Purchaser expressly agrees that the remedies granted to it under this limited warranty are purchaser s sole and exclusive remedies with respect to any claim of purchaser arising under this Limited Warranty Managing Director BodyGuardOperatorManual a INDEX A Accuracy 11 12 17 23 29 75 Administration Sets 2 5 16 17 21 30 33 35 36 41 46 48 50 53 60 73 74 76 Air in Line 2 16 22 25 30 32 33 35 36 41 46 48 50 53 75 Air Sensor 2 8 16 21 22 25 30 31 33 3
48. ion The BodySet Microbore EE Spike Cap Keeps the set sterile 2 BodySet Spike Connects the administration set to solution 1 2 3 Administration Tubing 1 5 x 3 mm Transfers the solution 4 5 MEN Filter 1 2 micron Filters the fluid path from air and particles Male luer lock Connects the administration set to the patient access device 6 Male luer lock Cap Keeps the set sterile Administration Tubing 3x 4 1 mm Transfers the solution pumping segement Slide clamp Can be used to occlude the tube Prime valve Anti free flow valve with manual priming button Locates the tube in the correct flow direction 12 Anti Stretch locator Prevents incorrect tube stretching and locates the administration set correctly BodyGuard Operator Manual 8 4 Operation Loading the Administration Set cg NOTE Follow the instructions supplied with the individual administration set Warning Use of any administration set other than the BodySet may impair the operation of the pump and the accuracy of the Infusion Connect the administration set to the medication bag 2 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 Connect the administration set to the medication bag 3 Hold the section of tubing with the key small plastic block and make sure the flow direction is in
49. is empty displays the original value or the previous screen BodyGuard Operator Manual 49 4 Operation 1 PN 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 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 infused the total time and the up and down time Program operation will start from 2 ml h and will increase to the maximal rate During the flat session T2 the rate will not change During the last part of the program T3 the 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 E NOTE Before operating the pump in TPN program make sure that the IV bag contains an additional 5 ml of total volume to be infused This ensures adequate volume for KVO during End Program f Delay Before Start is set you must include enough volume for the delay period in addition to the 5 ml KVO volume Turn the pump on by pressing and holding the e until the Self Test screen appears l Warning If air sensor is off please contact your technician in order to enable the air sensor if disabled Using the pump with air in line detector off may
50. l 13 1 Introduction BodyGuard Operator Manual 14 2 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 EN Attention consult accompanying Instructions x IN C 4 CE mark indicates conformance to Medical Device Directive 93 42 EEC 0344 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 i Do not dispose of battery in municipal waste Symbol indicates separate collection Y for battery is required The use of single use disposable components on more than one patient is a biological hazard Do not reuse single use disposable components Type CF applied part Date of Manufacture Serial Number Expiry Date of disposable Lot Number STERILE Sterilized with Ethylene Oxide BodyGuard Operator Manual 15 2 Symbols Warnings and Cautions 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 warnin
51. l changed by the operator Changing Current Program Short Way 1 Turn on the BodyGuard Pump by pressing e until the Self Test screen appears If air sensor is OFF press to confirm 2 Once the Self Test is completed immediately press and hold E for two seconds The Program selection mode will be displayed 3 Scroll to the required program and press Cu E NOTE If the current selected program is PCA the Short Cut option is not available BodyGuard Operator Manual 35 4 Operation Continuous Infusion Continuous Infusion Rate Over Volume 1 Turn the pump ON by pressing and holding the e until the Self Test screen appears If air sensor is OFF please contact your technician in order to enable the air sensor if disabled 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 and status The status is either Program or Locked for instruction regarding locking and unlocking the pump refer to Lock Mode section When unlocked press Cu Wait for the rate screen to display amp NOTE When pump is in Program mode all parameters can be adjusted When pump is in lock out mode parameters can be viewed but cannot be changed e NOTE If pump is not in Continuous Program refer to changing program section for instructions 9 NOTE
52. l hr in 0 1 ml increments and 100 to 1200 ml hr in 1 ml increments Secondary Infusion Piggy Volume 0 1 to 9999 ml Intermittent Program e Used for setting a dose protocol at set intervals from 0 1 to 100 ml hr in 0 1 ml increments and 100 to 1200 ml hr in 1 ml increments Volume 0 1 to 9999 ml Interval Time 0 01 minute to 20 00 hours 25 Steps Program e Used for setting specific protocol that contains up to 25 steps Rate 0 1 to 100 ml hr in 0 1 ml increments and 100 to 1200 ml hr in 1 ml increments Volume 0 1 to 9999 ml for each step e Accumulated volume for all steps is up to ten liters TPN Program e Used for Total Parenteral Nutrition Volume 1 to 9999 ml e The program has a taper up taper down pattern The parameters to be set are Total Volume Time Up Time Down and Total Time The pump will calculate the ramping infusion rates PCA Program Used for 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 KVO The BodyGuard Infusion System uses a Keep Vein Open KVO mode that can run at the end of every program if desired KVO also runs during a delay before an Intermittent program and during Interval Time in the Intermittent program The KVO rate can be set from 0 1 to 5 ml hr If the programm
53. leted state for a long period of time may damage the battery 2X Connect the pump to the mains via the Charger whenever possible to recharge the battery AN Do not store the pump with the battery fully depleted AN Xylene Acetone or similar solvents could cause damage to components Do not clean the 21 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 Infusion pump into liquid could cause damage to components Do IN not immerse the pump into any type of liquid Battery damage could occur if left in a temperature warmer than 50 C 122 F BodyGuard Operator Manual 18 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 If any items are missing or damaged contact your BodyGuard supplier BodyGuard Infusion Pump Charging Cradle with Power Cord or Battery Charging Cable Rechargeable Battery Pack Operation Manual PCA bolus cable optional 9V Alkaline Battery compartment optional Disposable Battery Pack optional External charger optional Extended life battery Li Ion Polymer 3600 mAh optional External wall charger Optional BodyGuard Operator Manual 3 Installation and Set up 19 3 Installatio
54. ll display the rate in either ml h mg h or mcg h Bolus Volume The third line of the display shows the bolus volume for the current protocol As with infusion rate this will be displayed in mls mgs or mcgs depending on how the current program is set up Battery Status In the right hand margin you can see the battery and infusion status indicator The battery symbol will be visible when the pump is not connected to the mains charger User can check the charge level by monitoring the black fill inside the symbol i e completely black symbol indicates a fully charged battery Infusion Status In the right hand margin infusion status indicator shows drips moving down the screen when the pump is in operation BodyGuard Operator Manual 57 4 Operation PCA infusion Patient Activated Bolus A PCA infusion can 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 following two methods 1 Using Bolus Cable 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 2 Using Keypad PRIME BOLUS Press the button on the keypad E NOTE User can stop bolus at any time by pressing E E NOTE If patient requests more boluses than are allowed the pump will display Bolus Locked and will track the amount of boluses have been requested The bolus history can
55. mation about the pump and its programs see Info Mode chapter Pressing continuously locks and unlocks the keypad to prevent accidental or deliberate change to pump operation If needed 9 Down Arrow Scrolls down through options 10 Numeric Keys Enters numeric parameters during programming 1 Introduction BodyGuard Pump with Door Open Are SE Anton nction Fee Latch Holder nn the door closed when latch is in vertical position Pressure Sensor Detects downstream tubing restriction and occlusion Alarm level can be adjusted to suit patient needs Keyway Guides the IV line Pressing Plate Connected to the door by two springs Pump Door Covers the pressing plate eee A Direction Shows direction of pump poesi l a Anti Stretch locator Optional a the tube in the correct length from the key Air sensor Front Ultrasonic air detector which is mounted on the front housing BodyGuard Operator Manual 8 1 Introduction The Charger 1 Charger Display Displays major pump messages and operation values Release Handle Push to release the pump from the Charger BodyGuard Operator Manual 9 1 Introduction System Safety Checks The following details outline the safety checks designed into the BodyGuard infusion system to minimize the possibility of under or over infusions Free Flow Protection The system s customized IV lines are equipped with a check valve that prevents free flow towards the
56. me to prime the set and press CH to begin priming procedure You may stop priming at any time CD 4 The display screen will show a graph indicating the prime operation by pressing 5 Once the priming is 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 PCA Menu Screen Select Program Infusion and ress ED View History Review Set up Change Set up 2 New Patient Screen If programming a protocol for a new patient select New Patient by pressing If the protocol is not for a new patient press gt Pressing gt will clear the volume that has been infused to the current patient BodyGuard Operator Manual 54 se 4 Operation PCA infusion Rate Concentration Selection Screen e To program Rate in Milliliters per Hour ml hr press e To program Concentration in Milligrams per Milliliter mg ml press Once e To program Concentration in Micrograms per Milliliter mp ml press CR twice Rate or Concentration Screen Do one of the following e Press CH to confirm the existing parameters or e Enter the desired rate or concentration and press CH or NOTE To change from Concentration back to Rate enter 0 zero for Concentration and Concentration Rate Screen Only When Programming by Concentration Do one of the following press e Press to confirm the existin
57. move it from the charger Dropping the BodyGuard Infusion System could cause damage to components If the pump is X dropped return the pump for inspection by qualified service personnel 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 IV sets N 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 FAX forming Connect saline infusion in parallel to avoid this problem When operating the pump on PCA program the program will not enter KVO even if the limit volume is acceded The program will complete the bolus and than enter KVO Do not operate the pump near high energy radio frequency emitting equipment such as electro surgical cauterizing equipment False alarm signals may occur BodyGuard Operator Manual 000000000000 DA 2 Symbols Warnings and Cautions Do not let the pump operate when battery is fully depleted Pump may turn off during operation N on fully depleted battery without alarm Never operate the pump without performing the battery test as described in chapter 4 in this IN N manual Do not use the BodyGuard 323 for infusion of Insulin or for infusion of blood Cautions To avoid possible damage to the equipment observe the following Leaving the battery in a dep
58. n a graphic gt mas 0 6 30 12 Four PCA Data of current protocol P Rate 50 ml h Bolus 5 ML Lock Time 60Min A 4HLimit 100mi Five All programs Time and Date 7 Time 12 55 Date 15 11 02 Six All programs Actual Pressure Actual Pressure ENEN 1 0 7 21 BodyGuard Operator Manual 67 Pressing during data setting or in the stop mode will display the following Number of Information Screen button presses One Infused Volume Infused Total Volume to Be Infused A 1 500 ml 1000 Pressing STOP NO will clear Volume Infused T ti lecti wo Option Selection screen Velum nad Review setup gt Change setup To change parameters select Change setup press Start OK anf follow instructions in the Change setup section To view current pump settings select Review setup press Start OK and follow instruction in Review setup section NOTE 4 Operation e If no selection is made within ten seconds after pressing the screen will exit the information mode and display the previous screen e To exit the information mode after making a selection in Review Set up O once to return to the original screen e To exit the information mode after making a selection in Change Set up press Cu BodyGuard Operator Manual 68 4 Operation 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 Revie
59. n and Set up Charging the Pump s 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 off 1 Connect the charger unit to AC power and verify that the AC indicator is lit 3 The battery is charging when the red battery LED on the front of the charger is lit The battery is fully charged when the battery LED symbol turns green If the led does not light or does not turn green after more than 8 hours pls replace battery 4 Remove the pump from the charger by pressing the release button located next to the LED indicators on the charger and lift the pump out of the charger bottom first Caution Leaving the battery fully depleted for a long period of time may damage the battery BodyGuard Operator Manual 20 4 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 se An alarm message appears on the display An audible alarm sounds Infusion ceases The LED changes from green to red NOTE All tests should be performed in the Continuous program Pump Oper
60. ncnnnnnnnnnnnnnnnnnnnnnnnnannnnnnenennnnns 32 Operation Steps anne nennen 33 Pump Mounted on IV Pole cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeeeeees 33 Portable Gonnettion zn 33 Misc mc 34 Changing Current Program Using Level 1 Code 35 Changing Current Program Short Way eee 35 Continuous Infusion soe oe re E pet ede ibtd adosado a 36 Intermittent Infusion oooooooococooconoccccccnonononononononononnncnnnnnnnnnnnnnnnnnnnnnnns 41 Program Delay nnnnnnnnnnnnenn een 46 25 Steps Protocol a cero erre pH E Re DEDERE e EE ERES ERES 48 TPN lnfusion A a a 50 PGA Infusion et al a e a Ea Ea Ea 53 Setting Pressure Default For Down Occlusion 64 BodyGuard Operator Manual Lock Mode ira 65 HOW TO L06K iii oa 65 Inf6 Mode soo S EROR RU EDD KR RE NRI MM RAM DE E EE 67 REVIEW Sef Ups C 69 Change SeL UP AAPP A Lenna SESA koniino 70 5 Alarm Conditions and Troubleshooting 442 gt 72 Alarm Condition sosise aena aaa oaaae eaa aaa oaa aaa inaapi Sai 72 TROUDIGS NO OCG ida elek entre 73 6 SPEEIEAHONS an aeo as ex nt E anne Ad 75 7 Service and Maintenance 0 ccccccccccccceeeeeeeeeeeeeeeeseeaeeeeeeeeeeeees 77 CIC ANIOS 77 SIOrAgE run ee o oA 77 Battery Operation e 2 2 eat 78 LIMITED WARRANTY e eno el 79 BodyGuard Operator Manual 1 Introduction
61. onnected to the pump during priming 8 Set the required program and continue as described for every program setting I Warning Verify that infusion is proceeding normally before leaving the pump unattended Portable Connection 1 Connect the Bodyset MicroSet to the medication bag 2 Open the door of the pump and load the administration set into the pump s tubing guide 3 Turn on the BodyGuard Pump by pressing until the Self Test screen appears N 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 death or paralysis Switching the air detector off is not recommended and should be used only when absolutely necessary 4 Prime the administration set N Warning Make sure patient is not connected to the pump during priming 5 Set the required program and continue as described for every program setting AN Warning Verify that infusion is proceeding normally before inserting the bag and pump into X the carrying bag BodyGuard Operator Manual 8 4 Operation Programming The BodyGuard infusion System features five different programming options Continuous Program e Rate 0 1 to 100 ml hr in 0 1 ml increments and 100 to 1200 ml hr in 1 ml increments e Total Volume to be Infused 0 1 to 9999 ml e Program as Rate Over Volume or Volume Over Time Secondary Infusion Piggy Rate 0 1 to 100 m
62. or patients who require IV pain management or epidural analgesia Pain management is undertaken by delivering a continuous basal rate in combination with pre programmed boluses The pump will deliver only the boluses corresponding to the preset time intervals All attempts to obtain a bolus are stored in the pump memory The physician can read these statistics and adjust the settings as required Warning When operating the pump on PCA program with a rate of 0 0 ml h there is a hazard of blood clot forming Connect saline infusion in parallel to avoid this problem PCA Menu Due to the sensitive nature of PCA infusions the BodyGuard 323 has a specific menu to enhance the user experience while programming PCA infusions The menu organizes the infusion information centrally while maintaining the same programming format as the other infusion modes on the pump i 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 death or paralysis Switching the air detector off is not recommended and should be used only when absolutely necessary 2 Pump displays program name and status The status is either PROGRAM or LOCKED for instruction regarding locking and unlocking the pump refer to Unlocking PCA section Press CD If the pump is unlocked the PCA M
63. pump at 9 30 PM enter 2 1 3 0 Start Date Screen To change the Start Date type the desired start date using N the numeric keypad and press CH To start ED on 3 KVO During Delay Screen During delay time pump will operate in KVO mode Time left will count down until 00 00 and will then automatically start the progrmamed infusion During the delay this screen will be displayed showing when the infusion will start the same day do not change the date and ress CD e NOTE After delay time pump will beep once and infusion will start automatically Turning Pump Off In The Middle Of An Intermittent Infusion When the pump is turned OFF during an intermittent infusion the internal clock in the pump will continue to monitor the timing of the infusion If the pump is stopped during a dose the user will be able to resume the dose if the infusion is resumed before one third of the interval time has elapsed For example if the interval is 4 hours then the user can restart the infusion within 1 hour and 20 minutes of the interval time to receive the remainder of the dose In this case the pump will still resume the following dose at the scheduled time If the user restarts the infusion after one third of the interval time has elapsed then the user will not be receive the remainder of the dose The pump will resume in the middle of the interval and receive KVO until the next dose is due The purpose of this One Third rule is to
64. r in 0 1ml increments All other programs 0 1 to 100 ml hr in 0 1ml 100 to 1200 ml hr in 1 ml increments 600 ml hr PCA 0 1 to 1 000 ml Continuous TPN Intermittent 0 1 to 9999 ml 25 Steps 0 1 to 9999 ml for each step Accumulated volume for all steps up to 10 liters 100 hours 3 0 1 to 5 ml hr Ultrasonic adjustable air bubble size 21 psi Adjustable High 21 Normal 14 Low 7 110 240 VAC 50 60 Hz 0 3A max Rechargeable Li lon 7 2V 1800mAh Typical 20 hours Rechargeable Automatic when clicked into the Charger that is connected to an AC power source Six hours needed to charge a fully depleted battery 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 Lock Out Mode Missing Key When this symbol is seen consult accompanying documents 75 BodyGuard Dimensions Classification Housing Weight Electrical Safety Standards EMC Environmental Specifications IV Administration set BodyGuard Operator Manual 6 Specifications 112 x 89 x 32mm L x W x H Type CF Equipment degree of protection against electrical shock ABS fire retardant e 280 grams without battery e 390 grams with battery Complies with EN 60601 1 Medical Electrical Equipment Safety IEC 60601 2 24 Infusion pumps and controllers IEC 60601 1 4 Programmable Elect
65. ration Volumetric Calibration Value 26 Pressure Delta Pressure Calibration Delta Value 27 Pressure CAP Pressure Calibration Cap Value 28 EXIT EXIT BodyGuard Operator Manual 69 4 Operation Change Set up The Change setup mode allows you to make changes to the adjustable parameters To Access Change Set up 1 Press twice 2 Scroll to Change Set up option Press E To Adjust Pressure Level or Buzzer Level 1 D D Press G amp D to select an option and press 1 Y 2 Make adjustment by pressing or and press To Adjust Lock Out Option 1 Scroll to More and press Cu 2 Enter Level 2 Technician Code using the numeric keyboard and press Cu 3 Press m or A to change from OFF to ON and To Adjust Other Parameters 1 Scroll to More and press Cu press to approve 2 Enter Level 1 Technician Code using the numeric keyboard and press Cu 3 Press m or C select an option and press 4 Adjust the parameter by pressing Sw or or by using the numeric keypad BodyGuard Operator Manual 70 5 6 y 4 Operation Press CD to confirm selection and the screen displays Restart Pump d Press CD to continue The table below indicates the adjustable parameters Screen No Screen Information Pressure Level Action Choose pressure level High 21 psi Normal 14 psi Low 7 psi
66. reen gt Ge NOTE To access the PCA menu during operation press CD and then hold gt for 3 seconds NOTE LED indicator can be turned off in the main settings menu to save battery power 9 9 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 30mlh Users can fix a maximum rate that the pump can be set to in Change Set Up using the Technician Access Code to ensure other users cannot accidentally program the pump to deliver above this safe ceiling See later section for Change Set Up NOTE The BodyGuard is capable of delivering the bolus dose at up to 1000ml h The default setting is 600ml h designed to deliver any bolus as quickly as possible Users can adjust this if they want the bolus to be delivered over a longer period in Change Set Up using the Technician Access code Interpreting the Display Screen During PCA Infusion Programmed Infusion Rate ml hr or mg ml Infusion Mode Battery Status Patient Indicator Controlled Bolus Volume Infusion Status Indicator Infusion Mode The first line of the display indicates that the pump is in the PCA infusion mode Infusion Rate The second line of the display shows the current infusion rate Depending on whether the user programmed the current protocol in mls or mgs this wi
67. rical Medical System Manufactured in accordance to ISO 9001 2000 and ISO 13485 2003 CE marked In accordance with the Medical Devices Directive 93 42 EEC The BodyGuard Infusion System is designed to be in compliance with EN 60601 1 safety and IEC 601 1 2 EMC Non Operating Conditions Transportation and Storage Temperature 25 C to 50 C 13 F to 122 F Humidity 5 to 100 R H non condensing Air pressure 48kPa to 110kPa Operating Conditions The system may not meet all performance specifications if operated outside of the following conditions Temperature 18 C to 45 C 59 F to 113 F Humidity 20 to 90 R H at 40 C non condensing Air pressure 70kPa to 110kPa Dedicated IV administration sets with anti siphon valve 76 7 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 N Warning Always turn the pump off and remove the battery before cleaning foe Warning Always unplug the charger from AC power before cleaning 1 T N Caution Do not clean the pump or charger with chemicals such as Xylene Acetone or X 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 N C
68. ring operation e After a down stream occlusion infusion will restart from the stop point BodyGuard Operator Manual 4 Operation Lock Mode The BodyGuard provides three different level of locking e A Keypad Locking During operation all keys are disabled excluding the STOP NO and INFO key B Program Locking This feature enables the operator to lock out the setting keys so that entered parameters and set programs cannot be changed once they are set This option is important for example with children as users when there is a danger that the child might play with the pump and unknowingly change the program or for home care patients who repeat the same program every day Locking the program prevents mistakes in setting e C Maximal Rate Locking This feature enables the operator to set a maximal rate for the pump to accept The program rate then can be adjusted only up to a preset limit How To Lock A Keypad Locking 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 E NOTE The keys are locked in memory until they are unlocked or until entering Change setup mode To Unlock Keypad Press and hold until the entire graph is clear and a beep is heard The beep indicates that the locking program is turned OFF B Program Locking Press twice from STOP or setting mode 2 Scroll to Change Set up option
69. s short term fluctuation has little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the trumpet BodyGuard Operator Manual 1 1 Introduction Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered 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 Trumpet Graph at 1 ml h 2nd hour of delivery 50 40 2nd Hour Q Flow Rate 1 00 A Accuracy 0 3 30 20 Es ii i 10 20 30 40 50 2 5 1 19 3 Observation Window min Trumpet Graph at 1 ml h 4th hour of delivery 50 40 4th Hour Q Flow Rate 1 03 A Accuracy 2 9 30 Lm tw bu b 20 30 40 a ONEONE es 2 5 19 31 Observation Window min 9 E Max E Min dr Overall Mean Error BodyGuard Operator Manual 12 1 Introduction Start up Graph at 25 ml h Initial Period Flow ml hr 538858858548 vu o Trumpet Graph at 25 mi h 2nd hour of delivery 2nd Hour Q Fiow Rate 24 64 A Accuracy 1 4494 cemeterio norm een IN 2 5 11 19 31 Obsorvation Window min E Max it EMn de Overall Mean Error BodyGuard Operator Manua
70. s empty displays the original value or the previous screen BodyGuard Operator Manual 43 Volume Over Time 4 Operation Intermittent Infusion To program with Time and Volume instead of Rate and Volume enable the Time Option function by following the steps below 10 11 Press twice Scroll to Change Set up option Press Cu Scroll to More and press Cu Enter Change Set up Level 1 code using the numeric keyboard and press Cu Scroll to Time Option option Press Cu Press m or 4 to turn Time Option ON Press CH twice Bag Volume Screen Do one of the following y I e Press to confirm the existing parameters e Enter the Bag Volume and press CH Dose Volume Screen Do one of the following y e Press to confirm the existing parameters e Enter the Dose Volume and press Dose Time Screen Do one of the following e Enter the Dose Time and press Cu To enter 30 minutes press 0 0 3 0 Interval Time Screen Do one of the following e Press CD to confirm the existing parameters e Enter the time between the start of each dose and press CD BodyGuard Operator Manual 12 13 14 15 4 Operation Intermittent Infusion KVO Rate Screen Do one of the following e Press to confirm the existing parameters e Enter the KVO Rate from 0 1 to 5 ml h and press CD Accumulation Screen Do one of the following e Press CH to confirm the existing parame
71. stopped by pressing and holding Cae User can scroll through the following options by pressing D C e Restart Starts infusion exactly where it left off previously e New Bag Restarts infusion exactly where it left off previously and updates bag volume to be equal to the bag volume originally programmed e Menu Brings user back to the PCA Menu When asked for a code enter the Unlock L2 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 Menu 1 PCA Restart Menu Scroll to Menu using Q and press ED Enter Level 1 Technician Code and press BodyGuard Operator Manual 6 4 Operation PCA infusion Titrating Basal Rate During The Infusion To change Rate during the infusion enter the new rate using the keypad and confirm the new rate by entering the Level 1 Code The Rate can be increased up to the Max Titration Rate programmed into the specific infusion Titrating Bolus During The Infusion To change the Bolus during the infusion press the INFO button seven times until you reach a screen showing the currently programmed Bolus in ml or mg Use the keypad to enter the new Bolus and confirm t
72. te at 1200 ml hr using the Numeric keypad and press Cu 6 Set Volume at 9999 ml and press to start operation T Wait untill pump displays low battery message 8 Press e to turn the pump off 9 Connect the pump to a charger 10 Verify the red icon of battery is lit on the charger 11 Verify the red battery turns green after a minimum of 2 hours WARNING Do not let the pump operate when battery is fully depleted Pump may turn off during h operation on fully depleted battery without alarm Charger Indicator Test 1 Click the pump into the charger and connect the Charger to mains Disconnect the power cord from the AC power outlet 2 Verify that the CHARGE indicator is OFF m 3 Connect the power cord to the AC power outlet Verify that the CHARGE indicator is ON BodyGuard Operator Manual 24 4 Operation Dedicated BodyGuard Administration Sets The BodyGuard Infusion System should be operated only with BodySet dedicated Infusion sets N Warning Do not operate the BodyGuard Infusion System with any administration set FAIR other than the BodySet The BodySet Infusion Sets are equipped with a free flow protection valve to prevent a gravity free flow hazard Using a different set may essentially change the delivering rate and expose the patient to a free flow which can cause serious injury or even death Warning Using the pump with air in line detector off may cause an embolism resulting w death or
73. ted rate a NOTE If the rate change is not confirmed within ten seconds the pump will continue operation at the original rate and the display will return to the previous setting 2 To stop the infusion press D To change the rate while in Stop mode 1 Press any number on the keypad twice to return to the rate screen 2 Adjust the rate and press Cu 3 Adiust the volume and press NM times to restart infusion se NOTE During programming you may backspace by using Ge Pressing CF once clears the last entered digit Pressing C gain clears the next number Pressing when the value is empty displays the original value or the previous screen BodyGuardOperatorManual 37 Volume Over Time ee 4 Operation Continuous Infusion 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 To set Volume Over Time enable the time function by following the steps below 1 Press twice Scroll to Change Set up option Press Cu Scroll to More and press Cu Enter Change Set up Level 1 code using the numeric keyboard and press Cu Scroll to Time Option option Press ay twice Press to turn Time Option ON 98 Press Volume Screen Do one of the following 8 e Press to confirm the existing parameters e Ent
74. ters and start infusion e Press UM go back and adjust program parameters 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 During program operation the pump displays the rate in which the program is operating Resume Infusion Start New Bag or Restart Infusion When an Intermittent infusion is unlocked and stopped and the pump is re started the user has the following options BodyGuard Operator Manual 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 Intermittent Restart Screen Press m or to scroll to the appropriate selection and press Cu NOTE If pump is Locked the user will only have the Resume and New Bag options available Resume New Bag Restart Screen Display shows a summary of the current infusion to be started User can scroll through the details by pressing m DD Press to start infusion A E Nn 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 1 AN Press O twice from STOP or setting mode Warning If air sensor is off please contact your technician in order to enable the air sensor if disabled Using the pump
75. ump 10 1 Display Screen e Displays pump and infusion status e Displays programming choices and instructions 2 Up Arrow e Scrolls up through options 3 START OK e Starts infusion e Confirms selection and setting QD 4 STOP NO Stops infusion Silences an alarm condition Pause priming Zeroes the displayed value during programming Erases the last digit during programming Returns to previous screen BodyGuard Operator Manual 6 PRIME BOLUS c 0688 9 9668 3899 BodyGuard Operator Manual 1 Introduction 5 PRIME BOLUS Pressing Prime Bolus key during data setting Enables Priming procedure A graph appears on the display screen showing the priming volume with the current value increasing until reaching the set volume Pressing Prime Bolus key during Continuous program operation Enables Secondary Piggy Infusion Pressing Prime Bolus key during PCA program operation Enables bolus procedure 6 Power ON OFF Turn the system ON by pressing and holding the button until the Self Test Screen appears Turn the system OFF by pressing and holding the button until the graph is black and a beep is generated 7 Operation LED Green Indicator e Lights during system Self Test e Anintermittent green light indicates infusion delivery Red Indicator e Indicates an alarm state with a continuous red light e Lights when the pump is in a stand by mode during programming 8 INFO Supplies infor
76. vent occurs BodyGuard Operator Manual 62 4 Operation Press 2 and A to scroll through events When you find one of interest press O display further data relevant to this event on the status of the program and pump at the time of this event The user can scroll through the information shown here to check what the pump was set up for whether it was operating on battery or mains whether it was locked out and what the pressure settings and readings were at that time PCA Program Battery Operation Normal Level Battery Pressure Level Taken Pump Unlocked Vol Cal 540 Pressure Setting High Pressure DELTA 15 Pressure CAP 255 Pressure Baseline 88 Actual Pressure 88 BodyGuard Operator Manual a 68 4 Operation Setting Pressure Default For Down Occlusion se Turn the pump on by pressing and holding the until the Self Test screen appears If air sensor is OFF press D to confirm Pump displays program name and status Press Wait for the Rate screen to display Press twice Scroll to Change set up and press Cu Scroll to Pressure Default and press Cu Press Q or to adjust the level high normal low Press EN store the parameter in memory NOTE e The following pressure parameters can be set Low 7 psi Normal 14 psi High 21 psi e The selected pressure level will remain in memory until it is changed e The actual pressure can be viewed at any time by scrolling with the info button du
77. w Set up settings can be viewed but not changed Press twice 2 Press to scroll to Review Set up option Press Er CD a the current settings are displayed 3 To view the setting for a particular option select the desired option and press Cu pProgam Look Screen No Screen Display Information 1 Battery Level Current Battery Level Empty gt gt gt Full 2 Program Lock Option Currently ON or OFF 3 Time Date Time and Date 4 Tube Temperature Tube Temperature 5 Buzzer Level Current Buzzer Volume Setting 6 Pressure Level Current Pressure Level Setting 7 Pressure Default Current Pressure Default Setting 8 Select Program Current Selected Program 9 Priming Rate Current Priming Rate Setting 10 Maximal Bolus Volume Maximal Bolus Volume 11 Bolus Rate Current Bolus Rate Setting 12 Maximal Rate Current Maximal Rate Setting 13 KVO Rate Current KVO Rate Setting 14 Flow Control Flow Control 15 Air Bubble Size Current Air Bubble Size Setting 16 Store Last Program Option Currently ON or OFF 17 Operation LED Option Currently ON or OFF 18 Time Option Option Currently ON or OFF 19 Delay Before Start Option Currently ON 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 Calib
78. 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 Scroll to Change Set up option and press Cu Scroll to More and press Cu Enter Change Set up level 1 code using the numeric keyboard and press Cu Scroll to Delay Before Start option and press CH Turn delay option ON by pressing Q or EN Press GD the screen displays Restart Pump Press to continue Setting Delay Before Start After entering the program data the pump enables delay setting when Delay Before Start is turned ON se se NOTE The delay time is set according to a 24 hour clock This means that hours are viewed as follows 10 00 11 00 12 00 13 00 14 00 15 00 etc NOTE The pump automatically displays the current time and date To start pump immediately press CH to confirm the existing time and date and start infusion NOTE If the time and or date automatically displayed by the pump are not correct go to the Settings Menu and select Set Time amp Date to reset the clock in the pump BodyGuard Operator Manual 46 4 Operation Intermittent Infusion 1 Start Time Screen To change the Start Time type the desired start time using E Satine the numeric keypad and press To start Car immediately do not change the time and ress CD cg NOTE To start pump at 9 30 AM enter 0 9 3 0 To start the
79. y power supply for emergency use or for situations where the AC power is not available Note Replace the battery once every two years BodyGuard Operator Manual TR 7 Service and Maintenance LIMITED WARRANTY The BodyGuard Infusion Pump has been carefully manufactured from the highest quality components Caesarea Medical Electronics Ltd CME guarantees the pump against defects in material and workmanship for twelve 12 months from date of purchase by the original purchaser 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 The repair or replacement of any product under this Limited Warranty shall not extend the above mentioned Warranty period All repairs under this Limited Warranty should be undertaken only by qualified trained service personnel In the event that a pump is found to be defective during the warranty period the purchaser shall notify CME or its designated representative within thirty 30 days after such defect is discovered The defective pump should be sent immediately to CME or its designated representative for inspection repair or replacement Shipping costs are the purchaser s responsibility Material returned to CME or its designated representative should be properly packaged us
Download Pdf Manuals
Related Search
Related Contents
Télécharger le manuel d`utilisation BenQ MP510 Untitled Fiche technique Canon Pixma Pro 1 Scarica il catalogo 7. BUSCAR REVISTA-E - Universidad de Navarra Tech air Z0711 now to see HP ENVY Phoenix details. PAD-5035e Benutzerhandbuch “X80XX”H.264 Digital Video Recorder User Manual Copyright © All rights reserved.
Failed to retrieve file