BodyGuard 545 Epidural Infusion System Directions For Use Rev 00

BodyGuard 545 Color Vision™ Directions For Use

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BodyGuard 545 Color Vision™ Directions For Use

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BodyGuard 545 Color Vision™ Directions For Use

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Table of Contents 1- Introduction Overview Keypad Features BodyGuard 545 Color Vision™ Pump with Open Door BodyGuard 545 Color Vision™ Charger System Safety Checks Pump Accuracy 2- Symbols, Warnings, and Cautions System Symbols Terms Used In Manual Intended Use Warnings Cautions 3 – Installation and Set Up Unpacking Charging the Pump 4 – Operation Operating the Pump Access Codes & Keypad Lock Keypad Lock Dedicated Administration Sets The BodyValveTM Straight-Line Epidural MicroSetTM Loading the Administration Set Priming the Set Priming the Line Modify Protocol Select Protocol (Start an Infusion) Titrating Basal Rate During Infusion Patient Activated Bolus Auto Bolus Bolus Menu Clinician Activated Bolus Interpreting the Display Screen During Infusion MediGuardTM Option Automatic Bolus Rate Adjustment Using History Functions End of Program/Infusion and Bag Change Eliminating Air During Operation Down Occlusion Alarm 5 – Alarm Conditions and Troubleshooting Alarm Condition Alarm Definitions Definition of Alarm Types Sound Pressure Level (SPL) for Alarm Signals Troubleshooting View Set Up Change Set Up Pump Parameters 6 – Specifications 7 – Service and Maintenance Cleaning Storage Periodic Maintenance Battery Replacement Battery Operation LIMITED WARRANTY

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7 7 8 10 11 12 13 16 16 18 18 18 20 21 21 22 24 24 24 24 25 26 27 27 28 30 30 41 44 45 45 46 47 49 50 51 52 53 55 56 57 57 57 58 58 59 61 62 63 65 71 71 71 71 72 72 74

Ref.: DFU999-683EN Rev.00

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

1- Introduction Overview The BodyGuard 545 Color VisionTM Epidural System provides the following features:  Small, light, and compact pump  Multiple Delivery Methods:  Basal Only  Basal & Bolus  Bolus Only Multiple Bolus Types:    

Patient Bolus Auto Bolus Patient Bolus combined with Auto Bolus Programmed Intermittent Auto-Bolus (PIAB)

 Accurate fluid delivery  Operated with a custom safe administration set  Large multi-color display for continuous enhanced visibility  Rechargeable internal Lithium-Polymer battery  Battery charged in a pole mount charging cradle or with an A/C adaptor  Free flow protection valve as standard on all CME administration set  Quiet operation  Used for ambulatory care in a carrying pouch or mounted on an IV pole  2000 events log plus detailed patient history  Prevents false occlusion alarms when delivering boluses through an EPIDURAL catheter by automatically adjusting the bolus delivery rate  Post-Occlusion Bolus Reduction System  Uses color coding system to enhance safety (yellow striped or clear yellow tubing available)  MediGuardTM protection ensures drug protocols are suitable with patient weight

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

Keypad Features Front of BodyGuard 545 Color VisionTM Epidural infusion pump:

1

6 7 8

2 3 4

9

5

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1. Operation LED  Green Indicator  Lights during system self-test  An intermittent green light indicates infusion delivery  Red Indicator  Indicates a High Priority alarm state with a flashing red light  Yellow Indicator  Indicates a Medium Priority alarm state with a flashing yellow light  Indicates a Low Priority alarm state with a solid yellow light 2. 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 heard. 3. Lock Mode  Will lock keys to prevent settings changes.  Unlocks the pump.  Press continuously to lock/unlock the keypad to prevent accidental change to pump operation. 

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

4. INFO  Provides information about the pump and its programs (see Info Mode chapter).

5. Numeric Keys  Enter numeric values during programming BodyGuard 545 Color Vision Epidural

Pump Serial Number: V123456 Production Date: 1-Jan-2000

6. Display Screen  Displays pump and infusion status  Displays programming choices and instructions

Software Version BGCV545_02B Protocol Sample

7. STOP/NO  Stops infusion  Mutes the alarm condition  Stops priming  Clears the displayed value during programming  Navigates to the previous screen during programming

8. START/ OK  Starts infusion  Confirms selection and setting 9. BOLUS  Change bolus parameters during infusion.  Can be enabled/disabled under Change Set Up.  Activates clinician (CA) bolus when pump is in STOP mode. 10. Arrows  Scrolls up, down, right, and left through options.

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

BodyGuard 545 Color Vision™ Pump with Open Door 4 5 6 7

1 2 3

8 9

# 1.

Area Anti-Stretch locator

2.

Air sensor – Front

3.

Air sensor – Door

4.

Latch Holder

5.

Flow Direction Arrows

6.

Pressure Sensor

7.

Set Key

Holds the door closed when latch is in vertical position. Shows direction of pump operation indicating the flow to patient. Detects downstream tubing restriction and occlusion. Downstream occlusion alarm level can be adjusted to suit patient needs. Ensures the correct loading in the pump.

8.

Pressing Plate

Connected to the door by two springs.

9.

Pump Door

Covers the pressing plate.

BodyGuard 545 Color Vision™ Directions For Use

Assists user in administration set.

Function the correct

loading

of

the

Ultrasonic air detector, which is mounted on the front housing. Mounted on the door.

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1 - Introduction

BodyGuard 545 Color Vision™ Charger 1

3 4



2

# 1.

Area Charger Display

2.

Release Handle

Function Displays major pump messages and operation values. Push to release the pump from the charger.

3.

Charger LED (orange)

Indicates connections to supply mains.

4.

Pump Battery LED (red/green)

Indicates battery charge status.

NOTE: 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. The plug is the main isolation device for the pump. Do not position the pump in such a way to make it difficult to disconnect from the mains.

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

System Safety Checks The following details outline the safety checks designed into the BodyGuard 545 Color VisionTM pump 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 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.

Post Occlusion Bolus Reduction System

During an occlusion, pressure in the downstream section of the line can build up to 1100mmHg (depending on user defined settings). When the pump alarms the user will check the line and attempt to clear the occlusion. In the absence of Post Occlusion Bolus Reduction System the pressure build up could cause a surge of fluid into the patient. This feature works by reversing the operation of the motor until pressure in the downstream line is returned to neutral (usually within 15 seconds).

Unintended Bolus An unintended bolus is the volume of fluid that can be potentially delivered to the patient once an occlusion blockage in the administration line is resolved. The following table shows the potential unintended bolus volume under the specified conditions. Intermediate Rate 25ml/h

Occlusion Pressure 250mmHg (minimum) 1100mmHg (maximum)

Unintended Bolus Volume ≤0.5ml

An occlusion may pressurize the infusion tubing, which can result in an unintended bolus of drug when the occlusion is cleared. In order to prevent this potentiall bolus, disconnect the tubing or relieve the excess pressure through a stopcock, if present. The clinician should weigh the relative risks of disconnection with the risks of an unintended bolus of drug.

Air-in-Line Detection To improve the detection of air in the IV line, the BodyGuard 545 Color Vision™ 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 within a 15 minute 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 (+/- 50%) within a 15 minute period an air-in-line alarm is initiated. This accumulation feature is particularly useful with infusions for patients who are highly sensitive to air (i.e. infants, neonates, children) or when infusing products that create significant volumes of small air bubbles. BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

Program Limits (including MediGuardTM toxicity settings)

Under ‘Change Set Up’ users can choose from a number of options to limit protocol parameters and set safe ceilings on drugs infused. When the MediGuardTM feature is on users are asked to set the patients weight (kg) and a toxicity ceiling in ml, mg or mcg per hour per kilo bodyweight. If users try to set a protocol where the component elements (basal rate and boluses) exceeds the MediGuardTM limit the pump will alert the user to this and request they re-confirm their intentions, amend or revise the toxicity ceiling. Level One users will not be able to change the protocol or ceiling under Select Protocol and will have to select an alternative appropriate protocol or consult senior clinical staff with Level 3 authority. Alternatively you can choose to simply limit either the rate or number of boluses delivered over either a 1, 4, or 24 hour period according to local practice.

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 or 22° C). 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.

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

Trumpet Curves With the BodyGuard 545 Color VisionTM, 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 windows, 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.

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.

BodyGuard 545 Color Vision™ Directions For Use

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1 - Introduction

BodyGuard 545 Color Vision™ Directions For Use

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2 – Symbols, Warnings and Cautions

2- Symbols, Warnings, and Cautions System Symbols The following symbols are used on the BodyGuard 545 Color VisionTM 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. Caution

Warning

Refer to DFU Read the entire DFU before using the pump. Appears on the display after operator presses

to mute the alarm condition. Pump is

not infusing.

0344

CE mark indicates conformance to Medical Device Directive 93/42/EEC

Do not dispose of in municipal waste. Symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2002/96/EEC). NOTE: Does not apply to the battery. Do not dispose of battery in municipal waste. Symbol indicates separate collection for battery is required.

The use of single-use disposable components on more than one patient is a biological hazard. Do not re-use single-use disposable components. Type CF applied part Date of Manufacture Battery Serial Number Direct current BodyGuard 545 Color Vision™ Directions For Use

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2 – Symbols, Warnings and Cautions

Expiry Date of disposable Alternating current LOT

Lot Number (applicable to administration sets)

STERILE EO Sterilized with Ethylene Oxide (applicable to administration sets) Degree of particle and water ingress protection.

IP33

Definition of code: I = Ingress P = Protection 3 = Protection from solid objects ≥2.5 mm 3 = Protection from spraying water Class II Medical Electrical Equipment providing double insulation for operator and patient safety. Identifies the manufacturer of a product.

Indicates the authorized representative in the European Community.

Indicates the acceptable upper and lower limits of atmospheric pressure (altitude)..

Indicates the acceptable upper and lower limits of relative humidity.

Indicates the temperature limits to which the medical device can be safely exposed.

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

Indicates a medical device that should not be used if the package has been damaged or open.

Indicates the number of drops per milliliter.

BodyGuard 545 Color Vision™ Directions For Use

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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 warnings completely before operating the BodyGuard 545 Color VisionTM 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 545 Color VisionTM Infusion System.



NOTE: Indicates that the information that follows is additional important information or a tip that will help you operating the BodyGuard 545 Color VisionTM Infusion System.

Intended Use The BodyGuard 545 Color VisionTM Infusion System is designed for patients who require epidural pain management, requiring continuous and /or intermittent (bolus) delivery at precisely-controlled infusion rates through clinically acceptable routes of administration such as epidural and intrathecal routes. The BodyGuard 545 Color VisionTM Infusion System is for use by, or under the supervision of trained medical staff in the hospital.

Warnings To avoid possible personal injury or loss of life, observe the following

Read the entire DFU 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. Make sure the pump is attached securely to the Charger, which is connected firmly to an IV pole. 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 545 Color Vision™ should be operated only with the MicroSet™ IV lines. Use of IV lines other than the MicroSet™ may impair the operation of the pump and the accuracy of an infusion. 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 the manufacturer’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. BodyGuard 545 Color Vision™ Directions For Use

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2 – Symbols, Warnings and Cautions

Any adjustments, maintenance, or repair of the pump may impair the operation of the BodyGuard 545 Color Vision™ 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. The BodyGuard 545 Color Vision™ infusion system should be operated within the recommended environmental operating range. 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.

The plug is the main isolation device for the pump. No modification to this equipment is allowed. Do not use this equipment with other infusion systems or accessories that are not approved to be used with this pump system. Dropping the BodyGuard 545 Color Vision™ infusion system could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel. Do not operate the pump near high-energy radio-frequency emitting equipment, such as electrosurgical cauterizing equipment, or within 1800 ft of a transmitting television broadcast antenna. False alarm signals may occur. Do not let the pump operate when battery is fully depleted. Pump may turn off during operation on fully depleted battery. Before beginning infusion, ensure that the pump battery is fully charged. Prior to first use, technical service personnel shall verify functionality of pump per the Technical Service Manual.

Pump should be stored with the battery connected, otherwise the internal rechargeable battery may lose track of actual time. Do not use the BodyGuard Infusion Pump in close proximity to high energy medical equipment (e.g., Imaging equipment (i.e., X-Ray, MRI, CT Scan, etc.), High Frequency (RF) Surgical Equipment, Defibrillator, etc.) as this may cause degradation in performance of the Infusion Pump, which may affect proper infusate delivery. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BodyGuard Infusion Pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Lithium Metal Batteries – Forbidden for transport aboard passenger aircraft.

BodyGuard 545 Color Vision™ Directions For Use

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2 – Symbols, Warnings and Cautions

Infusion of blood or blood products should be retricted to a maximum rate of 600 ml/h.

Cautions To avoid possible damage to the equipment, observe the following: Leaving the battery in a depleted state for a long period of time may damage the battery. Connect the pump to the mains via the charger whenever possible to recharge the battery. Do not clean the pump or charger with chemicals such as Xylene, Acetone or similar solvents.These chemicals can cause damage to plastic components and paint. Use a lint-free cloth with hydrogen peroxide 10% or isopropyl alcohol 70%. Immersing the BodyGuard 545 Color Vision™ infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid. The BodyGuard 545 Color Vision™ infusion pump is not certified for use in oxygen-enriched environments. Battery damage could occur if left in a temperature warmer than 50C (122F). Potential strangulation may occur if the cables/tubing are of excessive length. Potential choking may occur if small parts are inhaled or swallowed. Potential allergic reactions may occur due to materials used in the pump. The front panel push buttons may become hot to the touch when the pump is operated in an elevated temperature environment up to 45 °C (i.e., outdoors or in a hot automobile).

BodyGuard 545 Color Vision™ Directions For Use

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