BodyGuard Twins 121 Operator Manual Feb 2011



NOTE: To assure proper use of the BodyGuard 121 Twins, C.M.E urges all users to read this manual carefully, become familiar with the procedures and system functions, and follow all recommendations herein.

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

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Table of Contents 1- Introduction ... 5 Overview ... 5 Button Descriptions and Functions ... 7 BodyGuard Pump with Door Open... 9 The Charger ... 10 System Safety Checks ... 11 Pump Accuracy ... 12 2 – Symbols, Warnings and Cautions ... 16 System Symbols ... 16 Intended Use ... 17 Warnings ... 17 Cautions ... 19 3 – Bodyguard 121 Twins - Installation and Setup ... 19 Unpacking ... 19 Charging the Pump ... 20 4 – Operation ... 20 Before Operating the Pump ... 20 Pump Operation Test (Channel 1) ... 21 Air in Line – Alarm Test ( Channel 1) ... 22 Down Occlusion – Alarm Test (Channel 1) ... 22 Door Open – Alarm Test (Channel 1) ... 23 Battery Test ... 24 Charger Indicator Test ... 25 Dedicated BodyGuard 121 Twins Administration Sets ... 25 The BodyValve ... 26 The BodySet ... 27 Loading the Administration Set ... 29 Priming the Line (same for both channels) ... 30 Priming Operation – before starting a program ... 30 Prime Operation – after air in line alarm ... 31 Operation steps... 32 Pump Mounted on IV Pole ... 32 Portable Connection ... 32 Programming... 33 Changing Current Program... 35 Changing Current Program – short way ... 36 3

Continuous Infusion... 36 TPN Infusion ... 41 Setting Down Occlusion ... 44 Program Delay ... 45 Dose Program ... 46 Intermittent Infusion (Optional) ... 49 Program Delay ... 53 25 Steps Protocol (Optional) ... 56 PCA Infusion (Optional) ... 58 Lock Mode ... 66 How To Lock ... 66 Info Mode... 67 View set up ... 69 Change set up ... 69 5 – Alarm Conditions and Troubleshooting ... 73 Alarm Condition ... 73 Troubleshooting (relevant channel) ... 74 6 – Specifications ... 77 7 – Service and Maintenance ... 81 Cleaning ... 81 Storage ... 81 Battery Operation ... 82 LIMITED WARRANTY ... 83

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1- Introduction Overview The BodyGuard 121 Twins provides the following features:



2 Channels pump



Small, light, and compact pump.



Multi Program: Continuous

Continuous program. Infusion Rate: 0.1 to 1200 ml/hr. Volume: 0.1 to 9999 ml. Bolus Volume: 0-100ml

TPN

BolusTaper Rate: 0.1-1200 Rate program, ml/hr with programmable up and down times.

DOSE

Dose program Dose: 0.1 to 250 kg in 0.1kg units. Volume: 0.1 to 99.9 ml in 0.1ml units 100 to 9999 ml in 1 ml units Concentration: 0.1 to 1000 mg/ml in 0.1 mg/ml units

Optional PCA

Dose: 0.1 to 1000 µg/kg/min in 0.1 µg/kg/min units Patient Control Analgesia: Continuous delivery plus /or programmed boluses. Bolus Volume: 0-25.5 ml Clinician Bolus Volume: 0.1-100ml Bolus Rate: 0.1-1200 ml/h

Optional Intermittent

A set dose delivered in set intervals. Between Intervals the pump will keep vain open (KVO Mode).

Optional 25 Steps

Operator can design a specific protocol for drug delivery which contains up to 25 steps. Infusion Rate: 0.1 to 1200 ml/hr Volume: up to 9999ml, for each step Accumulated Volume for all steps – up to 10 liters.



Highly accurate fluid delivery on either or both channels.

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

Operated with a customized safe administration set



Rechargeable internal lit-on battery.



Can be latched into a Charger, which is mounted on an IV pole



Anti-free flow protection valve on the administration set.



A.B.S. Anti-Bolus System



Silent operation



Drop sensor control (optional on both channels)



RS232 data collection



Bolus Cable (optional)

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Keypad Description and Functions Front of BodyGuard Infusion Pump

1 8

2 3 4

11

5 9 6 7

10

1. Display Screen 

Displays pump/infusion status



Displays programming choices & instructions

2. Up Arrow 

Scrolls up through options

3. START/ OK 

Starts infusion.



Confirms selection and setting.

4. STOP/NO 

Stops infusion.



Silences an alarm condition.



Pauses priming.



Zeroes the displayed value during programming



Erases the last digit during programming.



Returns to previous screen

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5. Prime Bolus 

Pressing Prime/Bolus key followed by Start/OK key during data setting: Enable Priming procedure. A graph appears on the display screen showing the priming volume with the current value increasing until reaching the set volume. Priming default volume: 20 ml.



Pressing Prime/Bolus key during operation enables the user to se an infusion of a piggyback bag.

6. Power ON/OFF 

Turn the system on, by pressing and holding the button until the self-test screen appears.

Turn the system off, by pressing and holding the button until the graph is black and a beep is generated. 7. Select Channels key Allows the user to move between channels 8. Two Operation LED ( one for each channel) 

Green Indicator 

Lights RED during system self-test



An intermittent green light indicates infusion delivery on the selected channel and lights continuously on the other channel.



Red Indicator 

Indicates an alarm state with a continuous red light



Blinks when the pump is in a stand-by mode during programming, on the selected channel or when the pump indicts low battery.

9. 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.

10. Down Arrow 

Scrolls down through options

11. Numeric Keys 

Enters numeric parameters during programming

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BodyGuard Pump with Door Open 7 6

# 1.

2.

Area

Function

Latch

Holds the door closed when

holder

latch is in vertical position.

Pressure

Detects

downstream

sensor

restriction

and

tubing

occlusion.

Alarm level can be adjusted to suit patient needs.

8

5

2

3.

Keyway

Guides the IV line

4.

Pressing

Connected to the door by two

Plate

springs.

5.

Pump door

Covers the pressing plate.

6.

Air

Ultrasonic air detector, which is

7.

3 4

– front

mounted on the front housing.

Air sensor -

Mounted on the door.

door 8.

1

sensor

Flow

Shows

direction

Direction

operation.

of

pump

9

The Charger 4

3

5

2 6

1 7

Led 1.

Pump channel one led

Description Green when channel I is infusing, Red when channel I is being programmed or under alarm, idle when channel II is on display.

2.

Battery charging led

Red when the battery is empty and being charged

3.

Battery charged led

Red when the battery is fully charged

4.

Channel one charger display

Displays channel I data

5.

Channel two charger display

Displays channel II data

6.

Mains led

Red when the pump is connected to mains

7.

Channel two pump led

Green when channel II is on display, Red when channel II is being programmed or under alarm, idle when channel I is on display.

01

System Safety Checks The following details outline the safety checks designed into the BodyGuard 121 Twins infusion system in order to minimize the possibility of under or over infusions.

Free Flow Protection The system‟s customized IV lines (on each channel) are equipped with an anti-siphon 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 one way valve also prevents one channel infusing in the other channel.

Anti-Bolus Function

The anti-bolus function is designed to reduce the bolus that may occur upon the release of an occlusion following a downstream occlusion alarm. Upon the detection of a downstream occlusion, the alarm is activated and the pump returns the IV line pressure to neutral within 15 seconds. Neutral line pressure is achieved by the reverse operation of the pumping mechanism, and measurement of the IV line pressure through the in-line pressure detection system.

Air-in-Line Accumulation

To improve the detection of air in the IV line, the BodyGuard 121 Twins Infusion system utilizes an air-in-line accumulation system in addition to the standard single bubble detection. This feature monitors the volume of air that passes through the IV line by accumulating the volume of individual bubbles of 1 ml over a moving window of 15 minutes. The limit is not configurable. Although an individual bubble may not exceed the pre-programmed threshold, the cumulative volume of bubbles of 1-milliliter volume may exceed the limit during the 15 minutes window and initiate an air-in-line alarm. 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.

00

Pump Accuracy The following graphs and curves were derived from testing described in IEC60601-2-24. Testing was 0

performed under normal conditions at room temperature (72 F). Any deviations from normal conditions and room temperature may cause changes in the accuracy of the pump.

Start-up Curves

The Start-up curves represent continuous flow versus operating time for two hours from the start of the infusion. They exhibit the delay in onset of delivery due to mechanical complexity 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.

02

Trumpet and Flow Rate With the BodyGuard 121 Twins, 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 is measured (start up curves).

Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods, “Observation windows”, as opposed to continuous data versus operating time. Over long observation windows, short-term fluctuations have little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short-term fluctuations have greater effect 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.

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2 – Symbols, Warnings, and Cautions System Symbols The following symbols are used with the BodyGuard Infusion System and components. Labels on the system or statements in this manual preceded by any of the following words and/or symbols are of special significance intended to help you operate the pump in a safe and successful manner.

Attention, consult accompanying Instructions.

CSA mark 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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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 Infusion System.

Caution: Indicates that the information is a caution. Cautions advise you of circumstances that could result in damage to the device. Read and understand this manual and all cautions completely before operating the BodyGuard Infusion System.



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

Intended Use The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, nutritional fluids and general I.V. fluid therapy in hospital and home care environments.

Warnings To avoid possible personal injury or loss of life, observe the following: When Air Sensor is OFF – Use administration set with hydrophobic filter (which expels air from the administration set). The use of any other set can cause severe damage to the patient and is strictly forbidden. Using the pump with air-in-line detector off may cause an embolism resulting in 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 Voltage present in 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.

07

Blown fuses could pose 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). The equipment is not suitable for use in the presence of flammable anestheticair/oxygen/nitrous oxide mixture. Do not use the system in the presence of theses gases. Make sure the pump is securely attached 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 121 Twins should be operated only with the BodySet/MicroSet IV lines. Use of IV lines other than the BodySet/MicroSet may impair the operation of the pump and the accuracy of 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 MicroSet only. Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the BodyGuard 121 Twins Infusion System and/or the accuracy of infusion. Any adjustments, maintenance, or repair of the uncovered pump should be performed by authorized skilled technicians. Any adjustments, maintenance, or repair of the uncovered pump while connected to mains should be avoided. The BodyGuard 121 Twins Infusion System should be operated within a temperature range of 15C (59F) to 45C (113F) and up to 85% humidity. Operating the pump at temperatures and/or humidity outside that range may affect accuracy. Use of improper accessories represents unsafe operation. 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 the power outlet. To disconnect pump from mains, remove it from the charger. Dropping the BodyGuard 121 Twins 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 IV sets. Watch your fingers / nails when opening the pump door.

08

Do not operate the pump near high-energy radio-frequency emitting equipment, such as electro-surgical cauterizing equipment, and cellular telephones. False alarm signals may occur.

Cautions To avoid possible damage to the equipment, observe the following: Leaving the battery in a discharged 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 store the pump with the battery fully depleted. Xylene, Acetone, or similar solvents could cause damage to components. Do not clean the pump with these chemicals. Clean solution spills on the pump immediately. Use a damp cloth or sponge. A mild detergent may be used. Wipe thoroughly with a dry cloth. Immersing the BodyGuard 121 Twins Infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid. 0

Battery damage could occur if left in a temperature higher than 50 C (122F).

3 – Bodyguard 121 Twins-Installation and Setup 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 121 Twins Infusion Pump



Charger



Operation Manual

If any items are missing or damaged, contact your BodyGuard 121 Twins dealer.

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Charging the Pump 

NOTE: The pump is protected against overcharging. Connect the pump to the mains via the charger whenever possible to be sure that the battery is fully charged at all times.

Warning: If the battery is damaged during operation, while pump and charger are disconnected from mains, the pump will turn off.

1. Connect the charger unit to AC power, and verify that the AC indicator is lit (charger right side above channel II). 2. Put the pump into the charger and tighten the safety screw. Please see drawing on the charger. 3. The battery is charging when the red battery LED on the front of the charger is lit. (charger lower left side above channel I) The battery is fully charged when the full battery LED symbol turns red (charger upper left side above channel I). 4. Remove the pump from the charger by releasing the safety screw and lifting the pump out of the charger.

Caution: Leaving the battery discharged for a long period of time may damage the battery.

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. Perform the test on both channels.

When an alarm is activated the following occurs: 

An alarm message appears on the pump and charger display. Each channel has its own display. The alarm message will be shown on the display relevant to the channel in which the alarm



occurred. An audible alarm sounds.



Infusion ceases.



The operation LED changes from green to red.



NOTE: All tests should be performed in the Continuous program on both channels.

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Pump Operation Test (Channel 1) 1.

2.

Click the pump into a Charger connected to AC power. Verify that the CHARGE

Red LED on

indicator is on (on charger).

the charger

Insert a BodySet / MicroSet administration set, on left (green) channel, and close the pump 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”. Press

3.

key until the self-test screen appears. The pump will enable setting data of

channel 1. Press the Start/Ok key to confirm channel 1 or press Channel key to enter channel 2 data.

4.

After switching the pump on, Channel 1 and the program selected will be displayed on the screen. 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 overview, press Start/Ok key to display the last set rate. If air sensor is off, Press Press

to confirm.

to prime the IV line.

PRIME DISCONNECT PATIENT

5.

Warning: Ensure the set is not connected to a patient!! Press

to start priming. The screen shows the

6.

progress bar of the priming operation.

7.

When priming has completed, wait 2 minutes without pressing any key. After two minutes the screen displays “Pump Unattended” and an alarm will sound.

8.



Press

Press OK to Start

PRIME

10ml

Pump Unattended 0

20

Press Start key

to silence the alarm.

NOTE: Same tests should be performed for channel 2.

20

Air in Line – Alarm Test ( Channel 1) 1.

Insert a BodySet administration set in Channel 1 and close the pump door. Press the door until a click is heard. Switch the pump on.



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

2.

The pump will display channel 1 and the program selected. In order to edit channel 2 press the CHANNEL key once.

3.

The pump displays Channel 1 and the program selected. Press setting. If air sensor is off, Press

4.

to confirm.

Set/change the infusion rate at 500ml/hr, using the numeric keypad and press

6.

Rate 500 ml/h

to confirm setting. Verify that

the charger‟s display shows 500. 5.

to show the last rate

Set Volume at 20 ml. press

Press OK for Volume key.

Volume 20 ml

The pump display will show the accumulation screen where

Press OK Key Rate

500 ml/h

all set data is shown, check the settings, if correct, press

Volume left

20 ml

Infused

to start operation

0 ml

Press Ok to Start 6.

Disconnect the IV line from the IV bag or turn the drip chamber upside down (applicable to the BodySet only) to allow an air bubble greater than 5 mm to enter into the administration set.

7.

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

8.

Press

to turn the alarm off.

 NOTE: Same tests should be performed for channel 2.

Down Occlusion – Alarm Test (Channel 1) 1.

Insert a BodySet administration set in channel 1 and close the pump door. Press the door until a click is heard.

2.



o

Make sure room temperature is 21-23 c.

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

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