BodyGuardTM 323. BodyGuard 323 Multi-Therapy Ambulatory Infusion Pump. Patient Guide

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1 BodyGuardTM 323 BodyGuard 323 Multi-Therapy Ambulatory Infusion Pump Patient Guide

2 How to Use This Booklet This booklet gives you information about how to use your BodyGuard 323 infusion pump. It supplements the instructions given to you by your healthcare provider. Some of the information may not apply to your treatment or the pump you are using. Your healthcare provider will explain the information you need to know for your specific treatment and the way your pump is set up. Your healthcare provider may write down additional instructions about your treatment, including who to call if you have a question or problem. 1 Table of Contents Section Page Warnings and Precautions 2 About Your BodyGuard 323 Pump 4 Pump Overview 4 Pump Carrying Pouch 5 Keypad Control Buttons 5 Pump Display Screen 6 Starting and Stopping the Pump 7 Recharging the Battery 8 Changing Disposable 9-Volt Batteries 11 Delivering a Bolus Dose 13 Changing the Bag/Tubing Set 13 Pump Cleaning and Care 19 Alarm Signals and What to Do 21 Who to Call for Help Back Cover

3 Warnings and Precautions Please observe the following warnings, precautions and instructions. Failure to do so could result in damage to the pump, or death or serious injury.! WARNING Do not drop the pump, knock it against hard objects or put heavy weight on top of it. If any of these things happen, inspect the pump for damage. If the pump is damaged or is not functioning properly, turn off the pump power and contact your healthcare provider immediately. Do not try to open the pump casing, take the pump apart or fix the pump yourself. Voltage present on the internal components may cause severe electrical shock resulting in death or serious injury. If a problem occurs or the pump is not functioning properly, turn off the pump power and contact your healthcare provider immediately. Before starting medication infusion, check the tubing for a pinched or twisted tube, a closed clamp or other occlusions (blockages) and for any air bubbles. Correct any occlusion and remove any air bubble as instructed by your healthcare provider. 2 Before removing the medication bag/tubing set, close the tubing with the clamp to prevent uncontrolled infusion of medication. Before connecting the pump tubing to your IV catheter, check all tubing for air bubbles. Remove any air bubbles as instructed by your healthcare provider. Air bubbles in the tubing can cause an air embolism. Do not prime the tubing set with the tubing connected to your IV catheter. This can cause over-infusion of medication or an air embolism. Operate or store the pump only in temperatures between 59 and 113 F, and at a humidity level no higher than 85%. Do not use the pump in the presence of flammable anesthetics or explosive gases. The pump presents a possible explosion hazard if used in the presence of such materials.

4 ! CAUTION Do not use the pump if you think it might be damaged or is not working properly. Turn off the pump power and contact your healthcare provider immediately. If the pump alarms, follow the instructions in this booklet or the instructions given to you by your healthcare provider. Do not leave the rechargeable battery empty for more than several hours. This may damage the battery. Recharge a low or empty battery as soon as possible by connecting the pump to the wall charger plugged into a wall outlet or other AC power source. Do not store the pump with the rechargeable battery empty. This may damage the battery. Recharge a low or empty battery as soon as possible by connecting the pump to the wall charger plugged into a wall outlet or other AC power source. 3 Do not use the pump near high-energy radio-frequency sources, such as cell phones. Exposure to these sources may trigger false alarm signals in the pump. Do not allow water or other fluids to get inside the pump. Fluids getting into the pump may damage it. If the pump gets wet, turn off the pump power and contact your healthcare provider immediately. Do not clean the pump with acetone, other plastic solvents or abrasive cleaners. These chemicals can damage the pump s components. Use the pump only as directed by your healthcare provider. Failure to use the pump according to your healthcare provider s instructions may interfere with your treatment. Patients using the pump on their own, or individuals responsible for helping patients to use it, must be instructed in its proper use. Patients must not use the pump on their own if they have not been properly instructed. This pump has been prescribed for you only, as part of your treatment. Do not let others use it. Federal (USA) law restricts this device to sale by or on the order of a physician.

5 About Your BodyGuard 323 Pump You have been prescribed the BodyGuard 323 ambulatory infusion pump as part of your treatment. Infusion means that the pump delivers (or infuses ) medication from a medication bag through a set of tubing and your IV catheter into your bloodstream. The healthcare provider can program the BodyGuard 323 pump to operate in a variety of automatic modes to control how it infuses medication. Once your pump is started, it may infuse medication continuously or in a stop and go pattern, depending on the treatment you require. Your healthcare provider will explain your treatment and what to expect. 4 If your pump is programmed to infuse Patient Controlled Analgesia (PCA), you may be permitted to give yourself additional bolus doses of medication when needed for pain relief. Your healthcare provider will explain how to do this. Pump Overview Display Screen Shows information about pump operation Keypad Control buttons to operate the pump Tubing Door Open to change tubing set Status Light Blinks green when pump is operating. Shows red when pump is stopped or alarming.

6 Pump Carrying Pouch The carrying pouch provides an easy way for you to wear and protect the pump and medication bag during your daily activities. Keypad Control Buttons 5 Note: Your healthcare provider will explain which buttons you can use. ON OFF Press and hold to turn pump power on or off. Before turning power off, stop infusion. NO Stops infusion. Silences alarm. START OK PRIME PIGGY Info Starts infusion. Primes tubing set. Starts bolus dose. Press during infusion to view current level of battery power and check pump operating status. 2 0 Press up and down arrow keys to scroll through menu options on display screen.

7 Pump Display Screen Infusion Mode Battery Level Indicator Shows current battery life. Full black means a full battery. No black means battery is empty. C O N T Rate 50 ml/hr Infusion Rate Operating Indicator Symbols ( drips ) moving down the screen mean pump is operating. 6 Pump Display Screen (PCA mode only) Infusion Mode Infusion Rate Battery Level Indicator Rate Bolus PCA 4.5 ml/hr 2 ml Operating Indicator Bolus Volume Note: The information on your pump s display screen will be different depending on your treatment. Your healthcare provider will explain the information you will see on your pump s display screen.

8 Starting and Stopping the Pump To Start the Pump ON 1. Turn the power on by pressing the button. 2. The display screen will show self-testing information for a few seconds as the pump powers up. The information on your pump s screen will be different from the illustration given here. 3. When the self-test information is replaced by a new display, follow the directions on the screen or the instructions given to you by your healthcare provider. OFF CME BodyGuard 323 Version XXXXX S.N. XXXXX 7 Instructions from your healthcare provider:! WARNING Before starting medication infusion, check the tubing for a pinched or twisted tube, a closed clamp or other occlusions (blockages) and for any air bubbles. Correct any occlusion and remove any air bubble as instructed by your healthcare provider. An uncorrected occlusion of the tubing can cause under- or non-delivery of medication that may result in death or serious injury. Air bubbles in the tubing can cause an air embolism that may result in death or serious injury.

9 To Stop the Pump 1. Stop infusion by pressing the button. NO Press OK to Start 2 min ON 2. Turn the power off by pressing and holding the OFF button until the bar on the screen turns completely black. WAIT FOR BEEP OFF Note: After pressing the NO button, you have 2 minutes to turn off the power. At the end of 2 minutes without turning off the power, the pump will alarm to remind you to take action. Recharging the Battery 8 When to Recharge Your healthcare provider will explain if your pump uses a rechargeable battery. Follow your healthcare provider s instructions for checking the battery level and recharging the battery. The battery does not need to be empty to recharge. The battery will charge while the pump is operating, and even when it is not operating, as long as the pump is connected to the wall charger and the charger is connected to a wall outlet or other AC power source. That means the battery can recharge while you are sitting or resting.! CAUTION Do not leave the rechargeable battery empty for more than several hours. This may damage the battery. Recharge a low or empty battery as soon as possible by connecting the pump to the wall charger plugged into a wall outlet or other AC power source.

10 To Check Battery Level While the pump is operating, press the button 2 times. The Battery Level screen displays a black bar showing the current level of battery power. If less than one-third of the black bar is left, follow the below instructions to recharge the battery. Battery Level Info Empty Full If Low Battery Alarm Occurs 9 The pump s Low Battery alarm comes on when the battery has about 30 minutes before total loss of power. The audio alarm beeps every minute and the status light alternates between flashing green and red. The pump screen alternates between the Low Battery display and the Rate display. If this alarm occurs, follow the below instructions to recharge the battery. Low Battery Connect to Charger To Recharge the Battery Important: Do not remove the rechargeable battery for any reason. If you experience a problem with it, contact your healthcare provider. 1. Plug the charger into a wall or other AC outlet.

11 2. Connect the charger cable to the pump s DC port. To connect, match the clip on the cable plug to the slot located on the inside upper right of the DC port. Then push the plug all the way into the port. DC Port START OK 3. Wait two minutes. Then restart infusion by pressing the button. The battery will charge while the pump is operating. 4. During charging, the charger light shows red until the battery is fully charged. Then the light turns green When charging is complete, disconnect the charger cable from the pump. To disconnect, press and hold the black button on the cable plug while pulling the plug straight out. Additional instructions:

12 Changing 9-Volt Disposable Batteries If your pump uses disposable 9-volt alkaline batteries, follow the instructions below to remove and replace low batteries before they become empty. When Low Battery Alarm Occurs The pump s Low Battery alarm comes on when the batteries have about 30 minutes before total loss of power. The audio alarm beeps every minute and the status light alternates between flashing green and red. The pump screen alternates between the Low Battery display and the Rate display. Low Battery Connect to Charger 11 If the low battery alarm occurs, follow these 7 steps to change the batteries: To Change the Batteries 1. Stop infusion by pressing the button. NO Press OK to Start 2 min ON 2. Turn the power off by pressing and holding the OFF button until the bar on the screen turns completely black. WAIT FOR BEEP OFF Note: After pressing the NO button, you have 2 minutes to turn off the power. At the end of 2 minutes without turning off the power, the pump will alarm to remind you to take action.

13 3. Locate the pump battery case on the back of the pump. Pull up on the battery case release tab. Lift up the right side of the battery case to remove it from the pump. 4. Remove the batteries from the battery case. Replace them with 2 new 9-volt alkaline batteries. Insert them so that the + and - terminals on the batteries match the + and - slots of the battery case Insert the battery case back into the pump. Insert the left side of the case first. Then push down on the right side until the release tab clicks into place. Push the tab down to ensure that the case is secure. ON 6. Turn the power on by pressing the button. OFF 7. Restart infusion by pressing the START button and following the OK instructions on the display screen.

14 Delivering a Bolus Dose If you are receiving Patient-Controlled Analgesia (PCA) infusion for pain relief, your healthcare provider will explain when and how to give yourself a bolus dose of additional medication to relieve your pain. Use either of these 2 ways to give yourself a bolus dose, as instructed by your healthcare provider: PRIME 1. Press the button on the pump keypad. OR PIGGY 2. Insert the bolus dose cable plug into the jack labeled BOLUS on the side of the pump. Then press the button at the end of the cable to activate a bolus dose. 13 To stop a bolus dose, press the NO button. When to give yourself a bolus dose: Additional instructions: Changing the Bag/Tubing Set If appropriate for your treatment, your healthcare provider will explain when and how to remove an empty medication bag with attached tubing set and replace it with a full bag/tubing set. Change an empty medication bag/tubing set as instructed here:. Important: Handle the new medication bag/tubing set carefully to prevent contamination of the set and your medication: Before handling, wash your hands thoroughly with soap and running warm water for about 20 seconds.

15 Do not touch the open tubing ends with your fingers. Also, do not let the open ends touch your body or any other object. Use protective gloves if instructed by your healthcare provider. Other instructions: To Remove Old Bag/Tubing Set 1. Stop infusion by pressing the button.! WARNING Before removing the medication bag/tubing set, close the tubing with the clamp to prevent uncontrolled infusion of medication, which could result in death or serious injury. NO 2. Close the clamp on the old tubing set. To close the clamp, pull the tubing down into the narrow part of the clamp. 3. Close the clamp on your IV catheter as instructed by your healthcare provider Open the pump door by pulling down on the door latch located on the right side of the pump. 5. Remove the old tubing set from the pump by pulling it out gently with your fingers. 6. Disconnect the old tubing set from your infusion line. 7. Dispose of the old bag/tubing set as instructed by your healthcare provider:.

16 To Install New Bag/Tubing Set 1. Close the clamp on the new medication bag/tubing set. To close the clamp, pull the tubing down into the narrow part of the clamp. 2. Orient the new bag/tubing set so that the medication bag is to the left of the pump Locate the pumping segment of the new bag/tubing set. It is softer than the rest of the tubing. It is about 4 ½ inches long starting from the black set key. The set key fits into a slot that has the same shape and is located in the tubing channel of the pump. Set Key Pumping Segment 4. Match the set key to the slot. Then push the key all the way in. Tubing Channel Set Key Slot

17 5. Press the rest of the pumping segment into the tubing channel. Important: While inserting into the tubing channel, keep the pumping segment straight but do not stretch it. 6. Close the pump tubing door until you hear it click shut. 7. You are now ready to prime the new tubing set. Do not connect the new tubing set to your IV catheter and restart infusion yet. Wait until after you have primed the new tubing set.! WARNING Do not prime the tubing set with the tubing connected to your IV catheter. This can cause over-infusion of medication or an air embolism, which may result in death or serious injury. 16 To Prime the New Tubing Set Prime the new tubing set as instructed by your healthcare provider:. Or follow these 12 steps: Note: If you are receiving PCA infusion, your priming procedure will be different from this one. Prime the new tubing set as instructed by your healthcare provider. 1. Make sure you are NOT connected to the tubing set. The tubing set should not be connected to your IV catheter until after the tubing set has been primed.

18 2. Stop infusion by pressing the button. NO PRIME 3. Press the button. The Prime screen is displayed. PIGGY PRIME Disconnect Patient Press OK to Start 4. Press the START button. OK 5. Use the keypad buttons to enter the amount of priming fluid volume. This is usually 5 ml, or as specified by your healthcare provider: ml. 17 Prime Vol ml 5 Press OK to Continue START 6. Press the button to start priming the tubing set. OK The pump screen displays the progress of priming. The pump stops automatically when priming is complete. You can stop priming at any time by pressing the button. NO Prime 5 ml Repeat steps 3-6 above to infuse additional priming fluid.

19 ! WARNING Before connecting the pump tubing to your IV catheter, check all tubing for air bubbles. Remove any air bubbles as instructed by your healthcare provider. Air bubbles in the tubing can cause an air embolism that may result in death or serious injury. 8. When you are done priming the new tubing set, check all of the tubing for air bubbles. Follow your healthcare provider s instructions to remove any air bubbles from the tubing. 9. Connect the new tubing set to your IV catheter. Turn the connector until it is snug. Do not overtighten. 10. Open the clamps on the new tubing set and on your IV catheter Before starting infusion, check the new medication bag and tubing set to make sure they are: Properly connected Tubing is not twisted, pinched or clamped All air has been eliminated START 12. Press the button to restart medication infusion. OK Additional instructions:

20 Pump Cleaning and Care Your pump will require little routine maintenance if you use it in its protective carrying pouch. Inspect the pump from time to time. If it requires cleaning, or if a problem or alarm signal occurs, please observe the warnings, precautions and instructions listed below. Always turn the pump power off and unplug the wall charger from the outlet or other AC power source before cleaning the pump. Clean the outside of the pump from time to time using a lint-free cloth dampened with warm water and a mild detergent or disinfectant. Do not use caustic solvents like paint thinner or lacquer remover to clean the pump or wall charger. 19 Do not try to clean the inside of the pump. Do not immerse the pump or wall charger in water. If water or debris gets into the pump, turn the pump power off and contact your healthcare provider immediately. The pump is not waterproof so be sure to keep it dry. When showering, place the pump outside of the shower or in a waterproof bag. The pump carrying pouch is not waterproof. If the pump alarms, follow the instructions in this booklet or the instructions given to you by your healthcare provider to correct the problem. If you cannot correct a problem indicated by an alarm signal, contact your healthcare provider. If the pump appears damaged or is not functioning properly, turn off the pump power and contact your healthcare provider immediately.! WARNING Do not try to open the pump casing, take the pump apart or fix the pump yourself. Voltage present on the internal components may cause severe electrical shock resulting in death or serious injury. If a problem occurs or the pump is not functioning properly, turn off the pump power and contact your healthcare provider immediately.

21 ! CAUTION Do not use the pump if you think it might be damaged or is not working properly. Turn off the pump power and contact your healthcare provider immediately. If the pump alarms, follow the instructions in this booklet or the instructions given to you by your healthcare provider. Do not allow water or other fluids to get inside the pump. Fluids getting into the pump may damage it. If the pump gets wet, turn off the pump power and contact your healthcare provider immediately. Do not clean the pump with acetone, other plastic solvents or abrasive cleaners. These chemicals can damage the pump s components. 20

22 Alarm Signals and What to Do 21 Alarm Message What It Means What to Do Air/Up Occlusion Press to Mute Down Occlusion Check Line Press to Mute Low Battery Connect to Charger Occlusion (blockage) of tubing between medication bag and pump. Large air bubble in tubing. Medication bag is empty. Occlusion (blockage) of tubing between you and pump. Battery power is low. Pump will lose all power and stop in about 30 minutes. 1. Press NO to silence alarm. 2. Check for cause of blockage (clamp is closed, tubing is pinched, etc.) and correct it as instructed by healthcare provider. START 3. Press OK to restart infusion. 4. If alarm returns, press NO and check for large amount of air in tubing or for empty bag. Correct problem as instructed by healthcare provider. 5. If you can t correct problem, call your healthcare provider. 1. Press NO to silence alarm. 2. Check for cause of blockage (clamp is closed, tubing is pinched, etc.) and correct it as instructed by healthcare provider. START 3. Press to restart OK infusion. 4. If you can t correct blockage, call your healthcare provider. 1. If using rechargeable battery, connect pump to charger and plug charger into AC power outlet. Wait 2 minutes before restarting infusion. 2. If using disposable 9-volt alkaline batteries, remove and replace with fresh batteries. START 3. Press OK to restart infusion.

23 Alarm Message What It Means What to Do End Battery Connect to Charger Battery empty (total loss of power). Pump has stopped. 1. If using rechargeable battery, connect pump to charger and plug charger into AC power outlet. Wait 2 minutes before restarting infusion. 2. If using disposable 9-volt alkaline batteries, remove and replace with fresh batteries. START 3. Press to restart OK infusion. Pump Unattended Press Start Key During pump programming, 2 minutes have passed without control button being pressed. START Press to OK continue pump programming. Door Open Close Door Pump door is open. 1. Close pump door. START 2. Press to restart OK infusion. 22 End Program Infusion program is complete. If pump is not stopped, KVO will start (only if programmed by healthcare provider). Pump will repeat alarm until KVO stops. 1. Press NO to silence alarm. 2. Follow your healthcare provider s instructions or call your healthcare provider. 3. If no need to start another infusion program, ON press OFF to turn power off. Error XX (Number) Send for Service Pump malfunction. 1. Press Info to display 2-digit error number. 2. Write down number. 3. Press NO to silence alarm. ON 4. Press OFF to turn power off. 5. Call your healthcare provider.

24 Your Medication: When to Start the Pump: When to Stop the Pump: Additional Instructions: Who to Call for Help Healthcare Provider/Physician name: Daytime phone: After hours phone: Questions to Ask: CMEAmericaTM Drug Delivery Designed for the Way You Deliver CareTM CME America, LLC W. 6th Ave., Suite 830 Golden, CO USA 2008 by CME America, LLC. All rights reserved. The following are trademarks of CME America, LLC: BodyGuard, BodyComm, TSyringePump, the CME America logotype with swirl logomark and the tag line Drug Delivery Designed for the Way You Deliver Care. SM /2008

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