BodyGuard 575 Color Vision Operator Manual Ref 1000-095XCV Dec 2013

Table of Content 1 – Introduction Keypad Descriptions and Functions Pump with Open Door The Charger System Safety Checks Pump Accuracy 2 – Symbols, Warnings and Cautions System Symbols Terms Used In Manual Intended Use Warnings 3 – Installation and Set up Unpacking Charging the Pump 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 Dedicated Administration Sets The BodyValveTM Straight-Line PCA MicroSetTM Loading the Administration Set Priming the Set Modify Protocol Select Protocol (Start an Infusion) Titrating Basal Rate During Infusion Patient Activated Bolus Clinician Activated Bolus Interpreting the Display Screen During Infusion MediGuardTM Option Using History Functions Events Log 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 Alarm Condition Troubleshooting 6 – Specifications 7 – Service and Maintenance Cleaning Storage Battery Operation LIMITED WARRANTY BodyGuard 575 Color Vision™ Operator Manual

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1 – Introduction

1 – Introduction The BodyGuard Color Vision 575 TM PCA System provides the following features: 

Small, light and compact pump.



Multiple Programs:  Basal Only  Basal & Bolus  Bolus Only  Auto Bolus

 Highly accurate fluid delivery  Operated with a custom safe administration set  Large multi-color display for enhanced visibility  Wi-Fi capability (802.11) – upload/download real time data from the pumpmanipulate pump from distance (optional)  Rechargeable internal lithium-ion battery  Battery charged in a pole mount charging cradle or with an A/C adaptor  Free flow protection valve standard on every CME administration set  Quiet operation  Used for ambulatory care in a carrying pouch or mounted on an IV pole  2000 event 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 a PCA catheter by automatically varying bolus delivery rate.  Post-Occlusion Bolus Prevention System  Uses color coding system to enhance safety  MediGuardTM protection ensures protocol is appropriate to patients weight

BodyGuard 575 Color Vision™ Operator Manual

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1 – Introduction

Keypad Descriptions and Functions Front of BodyGuard 575 Color VisionTM PCA infusion pump:

1 5 6

2

7 3

8 9

4

10

1. Operation LED  Green Indicator  Lights during system Self-Test  An intermittent green light indicates infusion delivery  Red Indicator  Indicates an alarm state with a continuous red light  Lights when the pump is in a stand-by mode during programming 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 generated.

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1 – Introduction

3. INFO  Supplies information 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. 4. Numeric Keys  Enters numeric parameters during programming

BodyGuard Color Vision 575 PC Pump Serial Number: V123456 Production Date: 1-Jan-2000

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

Software Version: CVPCA30F_1

Protocol Sample

6. 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 7. START/ OK  Starts infusion  Confirms selection and setting 8. BOLUS  Administers bolus dose during PCA regimes (this function is normally performed using the remote bolus cable). Can be disabled under Change Set Up.  Activates clinician (CA) bolus when pump in STOP mode. 9. Up Arrow  Scrolls up through options 10. Down Arrow  Scrolls down through options

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1 – Introduction

Pump with Open Door

4 5 6 7

1 2

8

3

9

#

Area

Function Locates the tube in the correct length from the key (Optional). Ultrasonic air detector, which is mounted on the front housing.

1.

Anti-Stretch locator

2.

Air sensor – Front

3.

Air sensor - Door

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 Guides needs. the ADMINISTRATION line.

8.

Pressing Plate

Connected to the door by two springs.

9.

Pump Door

Covers the pressing plate.

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1 – Introduction

The Charger

1

2

#

Area

1.

Charger Display

2.

Release Handle

BodyGuard 575 Color Vision™ Operator Manual

Function Displays major 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 575 Color VisionTM pump 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 BodyGuard 575 Color VisionTM 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 line can build up to 21psi (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).

Air-in-Line Detection BodyGuard 575 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 575 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, 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 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. BodyGuard 575 Color Vision™ Operator Manual

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1 – Introduction

Pump Accuracy The following graphs and curves were derived from testing described in IEC60601-224. 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 575 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. BodyGuard 575 Color Vision™ Operator Manual

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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 575 Color Vision™ Operator Manual

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1 – Introduction

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2 – Symbols, Warnings and Cautions

2 – Symbols, Warnings and Cautions System Symbols The following symbols are used on the BodyGuard 575 Color VisionTM PCA 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

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 reuse single-use disposable components.

Type CF applied part Date of Manufacture Serial Number Expiry Date of disposable LOT STERILE EO

Lot Number 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 575 Color VisionTM PCA 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 BodyGuardTM Infusion System.



NOTE: Indicates that the information that follows is additional important information or a tip that will help you operating the BodyGuard 575 Color VisionTM PCA System.

Intended Use The BodyGuard 575 Color VisionTM PCA Infusion Pump is designed for patients who require PCA pain management, requiring continuous and /or intermittent (bolus) delivery at precisely-controlled infusion rates through clinically acceptable routes of administration. The BodyGuard 575 Color VisionTM PCA Infusion Pump is available in a blue colorcoded PCA format. We recommend dedicated pumps for differentiation between PCA administration & other IV drug administration to prevent medication errors. The BodyGuard 575 Color VisionTM PCA therapy 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 575 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 an IV pole. 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 line is not kinked or occluded. The BodyGuard 575 Color VisionTM should be operated only with the MicroSetTM administration lines. Use of administration lines 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. 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 MicroSetTM only. Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the BodyGuard 575 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 575 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.

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2 – Symbols, Warnings and Cautions

Dropping the BodyGuard 575 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 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. 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. 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 575 Color VisionTM Infusion Pump



Charging Cradle with Power Cord or Battery Charging Cable



Rechargeable Battery Pack



Operation Manual



Disposable Battery Pack (optional)



PCA bolus cable



9V Alkaline Battery compartment (optional)



External charger (optional)



Extended life battery Li-Ion Polymer

If any items are missing or damaged, contact your BodyGuard 575 Color VisionTM 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, pls. 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. BodyGuard 575 Color Vision™ Operator Manual

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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:     

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 Operation Test 1.

Click the pump into a Charger connected to AC power. Verify that the CHARGE indicator is on, red or green light (on charger).

2.

Insert a MicroSetTM 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” & “Priming the Line”.

3.

Press confirm.

4.

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.

5.

Prime the set according to the priming instructions following later in this manual.

6.

When priming is completed, wait 2 minutes without pressing any key. After two minutes the screen displays “Pump Paused Too Long” and

until the Self-Test screen appears. If air sensor is off, press

an alarm will sound. Press alarm again or

to silence the

PCA

10:00

-

to

70% ███■

Pump Paused Too Long

to exit alarm condition. Press

BodyGuard 575 Color Vision™ Operator Manual

key

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4 – Operation

Air in Line – Alarm Test 1.

Insert a MicroSetTM 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” & “Priming the Line”.

2.

Insert air into the administration line to allow an air bubble greater than 10 mm to enter into the administration set.

3.

Start infusion as instructed in the "Select protocol" section.

4.

Air in line alarm will be activated as soon as the air bubble enters the set segment located behind the pump door. Press

to turn the alarm off.

PCA

10:00

-

70% ███■

Air/Up Occlusion Check for air / occlusion Press

key to mute

Down Occlusion – Alarm Test 1.

Insert a MicroSetTM into the pump and close the door. Press the door until a click is heard.

2.

Make sure room temperature is 21-23 oC



NOTE: For instructions on how to load and prime an administration set refer to sections “Loading the Administration Set” & “Priming the Line”.

3.

Start infusion as instructed in the "Select protocol" section.

4.

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)

5.

Wait another 5 minutes and occlude the ADMINISTRATION line downstream of the pump (between the pump and the pressure gauge).

6.

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%):  500 ml/h up to 20 seconds  60 ml/hr up to 1 minute  1 ml/hr up to 80 minutes  0.1 ml/hr up to 11 hours



NOTE: The pressure threshold can be changed to suit patient need (refer to section on changing the current default Pressure Limit).

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