BodyGuard 545 CV 05A Operator Manual 100-094XCV Rev 2 Jan 2016

1 - Introduction

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NOTE: To assure proper use of the BodyGuard 545 Color VisionTM Epidural System, Caesarea Medical Electronics Ltd. urges all users to read this manual carefully, become familiar with the procedures and system functions and follow all recommendations. 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.

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

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1 - Introduction

Table of Contents 1- Introduction

Overview Keypad Features Tubing Chamber Description System Safety Checks Pump Accuracy 2- Symbols, Warnings and Cautions

System Symbols Terms Used In Manual Intended Use Warnings

4

4 5 7 10 12 15

15 16 16 16

3 – Installation and Set Up

19

Unpacking Charging the Pump

19 20

4 – Operation

Before Operating the Pump Pump Operation Test Air in Line – Alarm Test Down Occlusion – Alarm Test Door Open – Alarm Test Battery Test Charger Indicator Test 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 Modify Protocol Select Protocol (Start an Infusion) Titrating Basal Rate During Infusion Patient Activated Bolus Residual Patient Bolus Patient Activated Bolus Titration Auto Bolus Auto Bolus Titration Clinician Activated Bolus Interpreting the Display Screen During Infusion MediGuardTM Option Using History Functions End of Program/Infusion and Bag Change Eliminating Air During Operation Down Occlusion Alarm View Set Up Change Set Up Default Settings 5 – Alarm Conditions and Troubleshooting

Alert Condition Alarm Condition Troubleshooting 6 – Specifications 7 – Service and Maintenance

23

23 23 24 24 25 26 26 27 27 28 29 29 30 31 32 34 47 51 51 52 52 54 56 58 63 64 66 68 70 71 72 72 73 74

74 74 75 78 80

Cleaning Storage Battery Operation

80 80 81

LIMITED WARRANTY

82

BodyGuard 545 Color Vision™ Operator Manual

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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 Programs:   

Basal only Basal & Bolus Bolus only

Bolus can be one of the following:  Patient Bolus (PCEA)  Auto Bolus (AB)  Clinician Activated Bolus (CAB)           

Highly accurate fluid delivery Operated with a custom safe administration set Large multi-color display for continuous enhanced visibility Wi-Fi capability (802.11) – upload/download real time data from the pump and/or manipulate pump from distance (optional) Rechargeable 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 pole mounted 2000 events log plus detailed patient history Ability to output history to PC (printer or file) using BodyCommTM software (optional)  Utilize Wi-Fi technology (optional)

 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  Residual patient bolus feature

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1 - Introduction

Keypad Features Front of BodyGuard 545 Color VisionTM Epidural System:

1

3 4

6 7 8 9

5

10

2

1. Operation LED  Green Indicator  Lights during system self-test  An intermittent green light indicates infusion delivery  Red Indicator  Indicates an alarm status  Indicates stand-by status 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  Locks and unlocks the keypad 4. INFO  Repeated presses during infusion will display current protocol infusion information.  Repeated presses with the infusion stopped/paused will display protocol history in data and graphical formats.

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1 - Introduction

BodyGuard 545 Color Vision Epidural Pump Serial Number: V123456 Production Date: 1-Jan-2000 Software Version BGCV545_02B

5. Numeric Keys  Numeric keys (0 to 9): enters numeric parameters and Access Codes.  Decimal point: to separate the whole number from the fractional part of a number.  6. Display Screen  Displays pump and infusion status  Displays programming choices and instructions  Color fonts to distinguish text

Protocol Sample

7. STOP/NO  Pause infusion  Silences an alarm condition  Pause priming  Zeroes the displayed value during programming  Erases the last digit during programming  Returns to previous screen 8. START/ OK  Starts infusion  Confirms selection and setting 9. PRIME/BOLUS  Accesses bolus titration and lockout time titration during infusion  Activates clinician bolus (CAB) when pump is in STOP mode. 10. Arrows  Scrolls up, down, right and left through options

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1 - Introduction

Tubing Chamber Description 4 5 6 7

1 2 3

8 9

# 1. 2.

Area Anti-Stretch locator (round) Air sensor – Front

3.

Air sensor - Door

Function Locates the tube in the correct length from the keyway (optional). Ultrasonic air detector, which is mounted on the front housing. Mounted on the door.

4.

Latch Holder

Holds the door closed when latch is in vertical position.

5.

Flow Direction

Shows direction of pump operation.

6.

Pressure Sensor

7.

Keyway

Detects downstream tubing restriction and occlusion. Alarm level can be adjusted to suit patient needs. Guides the administration set.

8.

Pressing Plate

Connected to the door by two springs.

9.

Pump Door

Covers the pressing plate and tubing chamber.

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1 - Introduction

Pump Sides

1 2

3

# Area 1. DC port 2. Bolus port 3. Door latch

Function Charger cable connects here. PCEA bolus button cable connects here. Pull down to open door. Opens the door and holds it closed when latch is in vertical position.

Pump Rear panel 1

2

3

3 4

# Area 1. Pump battery 2. Battery release tab 3. Charger insertion grooves (pump to charger connector) 4. Charger locking slot

BodyGuard 545 Color Vision™ Operator Manual

Function Rechargeable battery or disposable battery pack fits into battery compartment. Pull up to unfasten. Connects the pump to the charger for pump charging. Pole mount charger locking pin inserts here to secure pump to charger.

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1 - Introduction

The Charger

1

3

2 4

# 1.

Area Charger display

2.

Release handle

3.

Pump to charger connector Connects the pump to the charger for pump charging. Mains power port and Connects charging unit to mains power supply. cable connector

4.

BodyGuard 545 Color Vision™ Operator Manual

Function Displays main pump messages and operation values. Push to release the pump from the Charger.

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1 - Introduction

System Safety Checks The following details outline the safety checks designed into the BodyGuard 545 Color VisionTM Infusion System to minimize the possibility of under or over infusions.

Free Flow Protection When the set is installed in the pump and the door close two ridges on the door clamp the set so only the movement of the motor pistons can allow fluid to pass. With the door open protection is afforded by a check valve, present in all MicroSetTM Sets, that prevents free flow towards the patient when the set is not attached to the pump. When the pump is attached to the set and delivering fluid, the pressure delivered by the pump opens the valve. The check valve also prevents reflux. The design of the check valve means that although a pressure of 2-3psi can open the check valve in the direction of the patient reflux cannot occur regardless of the pressure that builds up in the set.

Post Occlusion Bolus Reduction System During an occlusion, pressure in the downstream section of the administration set can build up to 1100mmHg (depending on user defined settings). When the pump alarms the user will check the administration set 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 downstream is returned to neutral (usually within 15 seconds).

Air-in-Line Detection BodyGuard 545 Color VisionTM utilizes two modalities to detect air-in-line. The ultrasonic detector can be configured between 0.0 (OFF) & 1.0mL on the BodyGuard 545 Color VisionTM pump for single bubble detection whilst a cumulative check triggers the alarm if an accumulation of smaller bubbles totals 1.0mL (non-configurable) in any 15 minute period. Although a single bubble may not exceed the user defined threshold (e.g. 0.5mL) if the cumulative volume of smaller bubbles exceeds 1mL (e.g. if three 0.4mL bubbles pass the sensor within a 15 minute period) an ‘Air/Up Occlusion’ alarm is activated. This accumulation feature is particularly useful when infusing products that create a significant number of small air bubbles (out-gas) to a patient who is highly sensitive to air (i.e. infants, neonates and children).

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 limits on drugs infused. When the MediGuardTM feature is set to ON users are asked to set the patient weight (kg) and a toxicity limit 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 limit. Level One users will not be able to change the protocol or limit 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.

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1 - Introduction

Hard limits It is important to understand that the Hard Limits can be exceeded by Clinician boluses unless the MediGuardTM option is activated. When the Hard Limit has been reached the pump will alarm and screen will read “OVER xx hr, LIMIT REACHED”. Users should acknowledge the alarm by pressing STOP. The program can then be resumed but basal infusion and patient bolus will be locked out until the end of the limit period set (1, 4 or 24 hours). Clinician Bolus may still be activated. During this inactive period 3 beeps every 3 minutes will alert the user to this Limit Reached until the limit time-set has expired. If there was a basal rate running when the Hard Limit (volume) was reached the basal rate will go to KVO rate (default setting KVO 0mL) the basal rate will continue at 0mL/per/hour until Hard limit time-set has expired and then the basal rate returns to the rate it was running at prior to LIMIT REACHED alarm.

Soft limits The BodyGuard 545 Color VisionTM enables the configuration, within each protocol, of titration limits on all aspects of the infusion profile. These “Soft Limits” allow the institution to configure not only the limits allowable but also the level of user access required for each function. Soft limits are generally well within the toxicity levels for the prescribed regime and act as a “guiding hand” to practitioners across your institution ensuring safe use at ward/clinic level by authorized users. Soft limits can be over-ridden by authorized personnel performing Clinician bolus top-ups over and above the soft limits.

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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 0 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.

Trumpet and Flow Rate 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.

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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.

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1 - Introduction

BodyGuard 545 Color Vision™ Operator Manual

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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.

Attention, consult accompanying Instructions

Refer to operating instructions

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.

IPX3

Device protected against spraying water.

Type CF applied part Date of Manufacture Serial Number The use of single-use disposable components on more than one patient is a biological hazard. Do not reuse single-use disposable components. Expiry Date of disposable LOT

Lot Number

STERILE EO

Sterilized with Ethylene Oxide

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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.

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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. The BodyGuard 545 Color VisionTM Infusion System is available in a yellow color-coded epidural format. We recommend dedicated pumps for differentiation between epidural administration & other IV drug administrations to prevent medication errors. The BodyGuard 545 Color VisionTM Infusion System is for use by, or under the supervision of trained medical staff in the hospital and the home care environments. Please ask your local representative or contact us direct for further details.

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 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. BodyGuard 545 Color Vision™ Operator Manual

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2 – Symbols, Warnings and Cautions

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). Boluses will be infused up to the full volume that is requested unless the user stops the bolus manually by pressing . 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. Make sure the pump is attached securely to the charger, which is connected snugly to a pole stand. A kinked or occluded administration line may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the administration set is not kinked or occluded. The BodyGuard 545 Color VisionTM Infusion System should be operated only with the MicroSetTM administration sets. Use of administration sets other than the MicroSetTM 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 manufacture’s package. Administration of drugs other than those indicated for epidural use could result in serious injury to the patient. For epidural administration of drugs use MicroSetTM only. Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the BodyGuard 545 Color VisionTM 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 VisionTM 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. 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, remove it from the charger. BodyGuard 545 Color Vision™ Operator Manual

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2 – Symbols, Warnings and Cautions

Pump should be stored with the battery connected, otherwise the internal rechargeable battery may lose track of actual time. Dropping the BodyGuard 545 Color VisionTM Infusion System could cause damage to components. If the pump is 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 administration sets. Watch your fingers and nails when opening the pump door. When operating the pump on PCEA 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. When operating the pump on PCEA program, the program will not enter KVO, even if the limit volume is acceded. The program will complete the bolus and then enter KVO. In a clinical setting, bolus cables can be damaged by crushing (under foot or in the bed frames) or cutting (trapped in the bed-frame or cut by scissors when removing dressings, etc.)

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3 – Installation and Set Up

3 – Installation and Set Up Unpacking 1.

Carefully remove the pump and Charger from the box.

2.

Make sure no items were damaged during shipment

3.

Make sure you have the following items: 

BodyGuard 545 Color VisionTM Infusion System



Charging cradle with power cord or battery charging cable



Rechargeable battery pack



Operation manual



Disposable battery pack (optional)



Bolus cable



9V alkaline battery compartment (optional)



External charger (optional)



Extended life battery Li-Polymer

If any items are missing or damaged, contact your BodyGuard 545 Color VisionTM Infusion System supplier.

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3 – Installation and Set Up

Charging the Pump 

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.

2. Put the pump into the charger (top first) until it clicks into place.

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 6 hours, replace battery. 4. Remove the pump from the charger by pressing the release button (located next to the LED indicators on the charger), Lift the pump out of the charger bottom first. Caution: Leaving the battery discharged for a long period of time may damage the battery. The pump is powered by an AC (mains) power source. The pump uses one external rechargeable 1800mAh Li-Polymer battery or two disposable 9v alkaline batteries in a battery pack as alternate power sources. To assure continuous operation, the pump will switch from AC to battery power automatically in the event of AC power interruption. The pump also switches to battery power when disconnected from AC power. For example, if the patient needs to ambulate, you can disconnect the pump from AC power and it will automatically continue operating on battery power until reconnected to AC power. BodyGuard 545 Color Vision™ Operator Manual

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