CME BodyGuard 121 Twins Operator's Manual

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October 2014

Ref.: 100-090TO Rev. 1.0

BodyGuard 121

Twins

Infusion System

Operator Manual

MedNet GmbH.

Borkstrasse 10 48163 Muenster Germany

T: +49 251 32266 0

Caesarea Medical Electronics Ltd.

16 Shacham street Industrial Park Caesarea North P.O.Box 4294 Caesarea 38900, Israel E: sales@cme-infusion.com W: www.cme-infusion.com

0344



NOTE: To assure proper use of the , 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.

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 – - 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 ....................................................................................................... 25

The BodySet ............................................................................................................ 26

Loading the Administration Set ........................................................................... 27

Priming the Line (same for both channels) ......................................................... 28

Priming Operation – before starting a program ................................................. 28

Prime Operation – after air in line alarm ............................................................ 29

Operation steps ....................................................................................................... 30

Pump Mounted on IV Pole .................................................................................... 30

Portable Connection .............................................................................................. 30

Programming .......................................................................................................... 31

Changing Current Program .................................................................................. 33

Changing Current Program – short way ............................................................. 33

Continuous Infusion............................................................................................... 34

TPN Infusion .......................................................................................................... 39

Setting Down Occlusion .................................................................................... 42

Program Delay .................................................................................................. 43

Dose Program ......................................................................................................... 44

Intermittent Infusion (Optional) .......................................................................... 47

Program Delay .................................................................................................. 51

25 Steps Protocol (Optional) ................................................................................ 54

PCA Infusion (Optional) ....................................................................................... 56

Lock Mode .............................................................................................................. 64

How To Lock .......................................................................................................... 64

Info Mode ................................................................................................................ 65

View set up .............................................................................................................. 67

Change set up ......................................................................................................... 67

5 – Alarm Conditions and Troubleshooting ............................................................ 71

Alarm Condition .................................................................................................... 71

Troubleshooting (relevant channel) ..................................................................... 72

6 – Specifications ........................................................................................................ 75

7 – Service and Maintenance .................................................................................... 79

Cleaning .................................................................................................................. 79

Storage .................................................................................................................... 79

Battery Operation .................................................................................................. 80

LIMITED WARRANTY ........................................................................................... 81

1- Introduction

Overview

The BodyGuard 121 Twins provides the following features:



2 Channels pump



Small, light, and compact pump.



Multi Program:

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

Rate taper program, with programmable up and down time.

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

Optional

Patient controlled analgesia: Continuous delivery plus/or programmable boluses. Bolus volume: 0-25.5ml Clinician bolus volume: 0.1-100ml Bolus rate: 0.1-1200ml/hr

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

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

Continuous

TPN

Dose

PCA

Intermittent

25 Steps



Highly accurate fluid delivery on either or both channels.



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 CME administration sets (optional).



A.B.S. Anti-Bolus System



Silent operation



Drop sensor control (optional on both channels)



RS232 data collection



Bolus Cable (optional)

Keypad Description and Functions

Front of BodyGuard Infusion Pump

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

1 3 2 5 6

4 8 10

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

BodyGuard 121 Twins with Door Open

Area

Function

1. Latch holder

Holds the door closed when latch is in vertical position.

2. Pressure sensor

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

Keyway (Optional)

Guides the IV line

4. Pressing Plate

Connected to the door by two springs.

Pump door

Covers the pressing plate.

Air sensor  front

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

7. Air sensor door

Mounted on the door.

Flow Direction

Shows direction of pump operation.

1 6 7 2 3 8 5

The Charger

Led

Description

Pump channel one led

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

Battery charging led

Red when the battery is empty and being charged

Battery charged led

Red when the battery is fully charged

Channel one charger display

Displays channel I data

Channel two charger display

Displays channel II data

Mains led

Red when the pump is connected to mains

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.

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.

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.

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 (720 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.

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.

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 Number

Sterilized with Ethylene Oxide

LOT

STERILE EO

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 121 Twins™ infusion pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents, blood or blood products infusion, and general fluids 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.

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 IV lines approved for use by the manufacturer and distributor. Use of IV lines other than the approved type 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.

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.

Battery damage could occur if left in a temperature higher than 500C (122F).

3 – Installation and Setup

Unpacking

Carefully remove the pump and Charger from the box.

Make sure no items were damaged during shipment

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.

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



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.

Pump Operation Test (Channel 1)

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

Red LED on

the charger

Insert an 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 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.

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 to confirm.

Press to prime the IV line.

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

Press to start priming. The screen shows the progress bar of the priming operation.

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

Press to silence the alarm.



NOTE: Same tests should be performed for channel 2.

PRIME DISCONNECT PATIENT

Pump Unattended

PRIME 10ml

Air in Line – Alarm Test ( Channel 1)

Insert an 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”.

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 to show the last rate

setting. If air sensor is off, Press to confirm.

Set/change the infusion rate at 500ml/hr, using the numeric keypad and press to confirm setting. Verify that

the charger’s display shows 500.

5. Set Volume at 20 ml. press key.

The pump display will show the accumulation screen where all set data is shown, check the settings, if correct, press

to start operation

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

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.



NOTE: Same tests should be performed for channel 2.

Down Occlusion – Alarm Test (Channel 1)

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

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”.

Rate 500 ml/h

Volume 20 ml

Rate 500 ml/h Volume left 20 ml Infused 0 ml Press Ok to Start

Press until the self-test screen appears. The pump displays Channel 1 and the program selected. Press the Start/OK key to display the last rate setting. If air sensor is off, press

to confirm.

Set the infusion rate at 500ml/hr, using the numeric keypad and press to display last volume set.

Set Volume at 20 ml.

The pump display will show the accumulation screen where all set data is shown, check the setting, if correct, press

to start operation.

Wait 5 minutes and 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)

Wait 5 more minutes and occlude the IV line downstream of the pump (between the pump and the patient).

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



NOTE: The pressure threshold can be changed to suit patient need (refer to section on

changing the current Default Pressure Limit).

Depending upon the set flow rate and pressure threshold, the Down Occlusion alarm will be activated.

11.

Press key to mute the alarm.



NOTE: Same tests should be performed for channel 2.

Door Open – Alarm Test (Channel 1)

Insert an administration set in channel 1 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”.

2. Press until the self-test screen appears.

Rate 500 ml/h Volume 20 ml

DOWN OCCLUSION

Rate 500 ml/h

Volume left 20 ml

3. The pump displays Channel 1 and the program selected. Press to change the display to

show the last rate setting. If air sensor is off, press to confirm.

Set the infusion rate at 500ml/hr, using the numeric keypad and press to display the last set volume.

5. Set Volume at 20 ml. Press the key.

The pump display will show the accumulation screen where all set data is shown, check the setting, if correct, press

to start operation.

Open the pump door.

“Door Open” alarm will be activated at once.

Close the door. The display will show STOP.



NOTE: Same tests should be performed for channel 2

Battery Test

Insert an administration set in both channels and close both doors. Press the doors until a click is heard in both channels.



NOTE: For instructions on how to load and prime an administration set refer to sections

“Loading the Administration Set” & “Priming the Line”.

Take the pump out of the charger.

Press until the self-test screen appears.

4. The pump displays Channel 1 and the program selected. Press to display the last rate

setting. If air sensor is off, press to confirm.

Set the infusion rate at 1200ml/hr, using the numeric keypad and press for volume.

6. Set Volume at 9999 ml.

Rate 500 ml/h

Volume 20 ml

Rate 1200 ml/h

Volume 9999 ml

Rate 500 ml/h

Volume left 20 ml

DOOR OPEN



The pump display will show the accumulation screen where all set data is shown, check the setting, if correct, press

to start operation.

Wait untill pump displays the “low battery” message

Press to turn the pump off.

Connect the pump to a charger.

10.

Verify that the red LED indicating an empty battery lights on (lower left side of the charger above channel one).

11.

Verify that the full battery LED lights red after 4-6 hours of charging (upper left side of the charger above channel one).

Charger Indicator Test

Click the pump into the charger and connect the charger to mains. Disconnect the power cord from the AC power outlet.

Verify that the CHARGE LED indicator (in the charger right side above channel II) is off.

Connect the power cord to the AC power outlet. Verify that the CHARGE LED indicator is on.

Administration Sets

The BodyGuard 121 Twins infusion System should only be operated with Infusion sets approved for use by the manufacturer and distributor.

Warning: Do not operate the BodyGuard 121 Twins Infusion system with any

administration set, other than that recommended by the manufacturer or its distributor. The optional BodySet/MicroSet Infusion Sets are equipped with a free flow protection valve, to prevent a gravitational free flow hazard. Using a different set may essentially change the administration rate and expose the patient to free-flow.

Low Battery

Rate 500 ml/h Volume left 20 ml Infused 0 ml Press Ok to Start

Set Based Anti Free-Flow Valve

The Anti free flow valve, BodyValve, enhances pump functioning by:

 Preventing free-flow in the event the set is detached from the pump.  Preventing back-flow (reflux) in the event several infusion pumps are connected simultaneously

to the same patient.

 Preventing free-flow in the event of a mechanical malfunction.  Preventing pump operation if the set has been loaded incorrectly.

Warning: Replace the administration set every 72 hours to lessen the incidence of bacteria

formation.

Warning: Disposables must be compatible with the medicine delivered.

Warning: Patient or operator injury may result if package is opened or damaged, or if

damaged components are used. Visually inspect contents and package before each use.

Warning: Air embolism can cause serious injury or death to the patient. Do not connect a

patient to the BodyGuard Infusion Pump until all trapped air has been cleared from the fluid path. Carefully read the instruction for loading an administration set. Punctured set components may cause air embolism as well.

Warning: Drugs must not be administered to the epidural space unless the drugs are

specifically indicated for this purpose and are administered in accordance with the indications included in the manufacture’s package insert accompanying the drugs. Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

Warning: For epidural administration of drugs use MicroSet only.

Caution: Component damage may occur if not installed properly. Assure all connections

are secure; do not over tighten. This will help minimize leaks, disconnection and component damage.

Loading the Administration Set



NOTE: Follow the Instructions supplied with the individual administration set.

Prepare the administration set by remove it from the sterile packaging leaving the end caps on the line.

Pull the door latch down (on the door’s bottom surface) to open the BodyGuard 121 Twins pump door.

Make sure the flow direction corresponds to the flow direction arrows inside the pump door.

Insert the IV tubing into the pumping canal. Insert the tubing from top down, and avoid stretching or pulling the tubing.

Ensure that the distal flow valve is on the right hand side of the pump if using a CME set or one that contains an anti-siphon valve.

Close the pump door until the latch clicks.

Warning: Use of any administration set, other than that recommended by the manufacturer

or its distributor, may impair the operation of the pump and the accuracy of infusion.



NOTE: Ensure that the tubing is inserted completely into the pumping channel. Same

procedure should be applied to both channels.

Warning: Use aseptic technique. Patient infection may result from the use of non-sterile

components. Maintain sterility of all disposable components and only use single use consumables marked once.

Priming the Line (same for both channels)



NOTE: the optional BodySet and MicroSet administration sets contain a one-way Anti-Siphon

valve also called Free-Flow valve. Therefore, the lines cannot be primed using gravity and must be primed using the BodyGuard 121 Twins priming function.

Prime function must be used:

Before starting a program

After air in line alarm

Warning: Always disconnect IV tubing from patient before starting priming procedure.



NOTE:

 The priming flow rate is performed at a rate of 600 ml/hr. During priming the air in line alarm

is disabled.

 The priming volume is adjustable from 0-60 ml (see “Change set up” section) with an initial

default setting at 20 ml.

Priming Operation – before starting a program

Insert an administration set in Channel 1 and close the pump door. Press the door until a click is heard. Switch 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 program selected. Press the key to confirm

channel 1 or press the channel key to enter channel 2 data.

The pump displays Channel 1 and the program selected. The display will automatically change

and display the last rate setting. If air sensor is off, Press to confirm.

When the display screen shows the existing program press

key to prime the administration set.

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

5. Press to start priming. You may stop priming at any time by pressing .

The display screen will show a progress bar indicating the priming operation.

Once the priming has completed, the display will change back to the previous screen the pump was in before priming.



Make certain that all air is removed from the IV line before connecting to the patient. To perform another priming operation, in case all air was not cleared from the set, open a door and close it,

Prime Operation – After Air in Line Alarm

Press to mute the alarm.

Disconnect IV tubing from patient.

3. Press once.

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

Press to start priming. You may stop priming at any time by pressing .

The display screen will show a progress bar indicating the priming operation.

When priming has completed make certain that all air is removed from the IV line.

7. Connect IV line to the patient and press to resume program.



NOTE: Same tests should be performed for channel 2. To change the display

to channel 2, use the Channel select key . User may prime channel one while setting program data on channel two.

PRIME DISCONNECTPATIENT

PRIME 10ml

PRIME

DISCONNECTPATIENT

Operation steps

As follows are the steps for starting infusion procedure. For detailed instructions regarding each step refer to the relevant sections in the Operation chapter.

Pump Mounted on IV Pole

Connect the administration set to medication bag; for each channel a bag (if necessary). Mount the bag on an IV pole.

Attach the pump into the charger. Mount the charger on an IV pole.

Connect the charger via a standard power cord to a grounded AC outlet.

Open channel 1 pump door and load the administration set into the pump’s tubing canal. Repeat, same operation, if necessary, for channel 2.

5. Turn on the BodyGuard 121 Twins pump, by pressing key until the self-test screen

appears.

6. The display will show Channel 1 and the program selected. Press the key to display

the last rate setting.

Prime the administration set.

Warning: Make sure patient is not connected to the pump during priming!!! Repeat the

same operation for channel 2 if necessary.

Set the required program and continue as described for every program setting.

Warning: Verify that infusion proceeds normally before leaving the pump unattended.

Portable Connection

Connect the administration set to the medication bag, for each channel, if necessary.

Open the door of channel one and load the administration set into the pump’s tubing canal. Do the same for channel two.

3. Turn on the BodyGuard 121 Twins, by pressing until the self-test screen appears.

4. The display will show channel 1 and the selected program. Press the to display the last

program, rate setting. If air sensor is off, Press to confirm.

Prime the administration set.

Warning: Make sure patient is not connected to the pump during priming!!! Perform the

same procedure for channel 2, if necessary.

Set the required program and continue as described for every program setting.

Warning: Verify that infusion proceeds normally before inserting the infusion bag and

pump into the carrying bag.

Programming

The BodyGuard 121 Twins infusion system features two different programming options:

 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  Dose: 0.1 to 1000 µg/kg/min in 0.1 µg/kg/min units

Continuous Program

 Rate: 0.1 to 100 ml/hr in 0.1 ml increments, and 100 to 1200 ml/hr in 1 ml increments  Total Volume to be Infused: 0.1 to 9999 ml  Program as Rate Over Volume or Volume Over Time  Secondary Infusion (Piggy) Rate: 0.1 to 100 ml/hr in 0.1 ml increments, and 100 to 1200 ml/hr

in 1 ml increments

 Secondary Infusion (Piggy) Volume: 0.1 to 9999 ml

TPN Program

 Used for Total Parenteral Nutrition  Volume: 1 to 9999 ml  The program has a taper up/taper down pattern. The parameters to be set are: Total Volume,

Time Up, Time Down and Total Time. The pump will calculate the ramping infusion rates.

Intermittent Program (optional)

 Used for setting a dose protocol at set intervals from 0.1 to 100 ml/hr in 0.1 ml increments,

and 100 to 1200 ml/hr in 1 ml increments

 Volume: 0.1 to 9999 ml  Interval Time: 0:01 minute to 20:00 hours

25 Steps Program (optional)

 Used for setting specific protocol that contains up to 25 steps  Rate: 0.1 to 100 ml/hr in 0.1 ml increments, and 100 to 1200 ml/hr in 1 ml increments  Volume: 0.1 to 9999 ml for each step  Accumulated volume for all steps is up to ten liters

PCA Program (optional)

 Used for PCA applications. Combines basal rate and pre-programmed boluses  Rate: 0.0 to 100 ml/hr in 0.1 ml increments  Volume: 0.1 to 1000 ml  Bolus Volume: 0 to 100 ml  Bolus Rate: 0.1 to 100 ml/hr in 0.1 ml increments, and 100 to 1200 ml/hr in 1 ml increments

Keep Vein Open Mode

The BodyGuard 121 Twins Infusion pump uses a Keep Vein Open (KVO) mode that runs automatically at the end of a program, if desired. KVO can also be set to run during a delay at the start of a program. The KVO rate can be set from 1-5 ml/hr with an initial default setting of five ml/hr. The KVO rate is adjustable through the “change setup” mode. To disable the KVO mode – set the KVO rate at 0ml/hr. If the programmed infusion rate is lower than the KVO rate, the KVO will run at the programmed infusion rate. KVO during End Program is limited to a volume of 5 ml.



NOTE: To use the automatic KVO at the end of a protocol, make sure that the IV bag

contains an additional dose over the volume to be infused.

End Program Mode

When a protocol has completed, an audible alarm will sound continuously and the display will indicate END PROGRAM – KVO (assuming KVO is enabled). To stop the alarm and enter a new program, press . If

the stop key is not pressed before the first 4 beep have sounded, KVO will begin automatically. KVO will run for four minutes. The pump screen then displays it is in KVO mode and continues into 4 more minutes of KVO administration at the set preset rate.

Changing Current Program

1. Turn on the BodyGuard Pump, by pressing until the self-test screen appears and the

screen will change to channel 1 and the set program. Press to enter channel 1 and display the last set mode.

2. When the Rate screen is displayed, press twice.

3. Scroll to "Change set up" option. Press .

4. Scroll to "More" and press .

Enter code 901, using the numeric keyboard and press .

6. Scroll to "Select Program" option. Press .

7. Scroll to the required program and press .

8. Press to restart the pump.



NOTE: The selected program will remain in the pump’s memory until changed by the

operator.

Changing Current Program – Shortcut

Volume Infused

View set up

Buzzer Level

> More …

Code

Technician

901

Pressure Default

> Select Program

Select Program

> CONTINUOUS

History

> Restart Pump

1. Turn on the BodyGuard Pump, by pressing until the self-test screen appears. Press

key to enter channel 1 and display the program selected.

Immediately press and hold for two seconds.

Scroll to the required program and press .

Continuous Infusion

Rate over Volume (Channel 1)



NOTE: Before operating the pump in Rate Over Volume, make sure that you are in the

Continuous Program and that the IV bag contains an additional 5 ml of volume. This ensures

adequate volume for KVO during End Program. If Delay Before Start is set, you must include enough volume for the delay period, in addition to the 5 ml KVO volume.

1. Turn the pump on by pressing and holding the until the self-test screen appears.

Pump displays Channel 1 and the program selected. Press . Wait for the rate screen to display.



NOTE: If pump is not already in Continuous program refer to changing program section for

instructions on how to change the program.



NOTE: Whenever you decide to set a new program, follow instructions at the bottom of each

screen.

Do one of the following:

 Press to confirm the existing parameters.

 Enter the desired rate using the numeric keypad and

Press .



NOTE: The screen will be blank upon initial setup.

Select Program

> CONTINUOUS

Channel l Continuous

Rate 500 ml/h

The screen displays the last set volume. Do one of the following:

 Press to confirm the existing parameters.

 Enter the desired volume using the numeric keypad and

press .

Enter delay time, if applicable. For further information regarding delay option – refer to delay program section.

Pump displays program accumulation screen. Do one of the following:

 Press to confirm the existing parameters

and start infusion.

 Press to go back to rate setting screen.

During program operation the charger displays the rate in which the program is operating. The pump displays the volume to be infused (vtbi) of each channel.



NOTE: -If one of the values is changed during the programming mode, the pump will not

recall the new value, unless changes are confirmed by pressing within 10 seconds. If prime procedure is activated during data setting, the pump will return to the original (previous) screen, once priming has completed.

Changing the Rate

The pump allows rate adjusting during the Rate Over Volume Program.

To change the rate during the infusion:

Use numeric keypad to enter the new desired rate, during operation and press within ten seconds to

confirm. The pump will bip once and the infusion will resume at the adjusted rate.



NOTE: If the rate change is not confirmed within ten seconds, the pump will continue

operation at the original rate and the display will return to the previous setting.

To stop the infusion press

Volume 456 ml

Rate 500 ml/h

Rate 500 ml/h Volume 456 ml Press OK to start

To change the rate while in Stop mode:

Press first during infusion.

Press any number on the keypad to return to the Continuous screen.

3. Press to proceed to the rate screen.

Adjust the rate and press .

Adjust the volume and press .



NOTE: During programming you may backspace by using :

Pressing STOP/NO once clears the last entered digit. Pressing STOP/NO again clears the next number. Pressing STOP/NO when the value is empty displays the original value or the previous screen.

Volume over Time



NOTE: Before operating the pump in Volume Over Time, make sure that you are in the

Continuous Program and that the IV bag contains an additional 5 ml of volume to be infused.

This ensures adequate volume for KVO during End Program. If Delay Before Start is set, you must include enough volume for the delay period, in addition to the 5 ml KVO volume.

To set Volume Over Time enable the time function by following the steps below (while pump is “stopped”:

1. Press twice.

2. Scroll to "Change set up", then press .

3. Scroll to "More" and press .

4. Enter code 901, using the numeric keypad and press .

Volume Infused

View set up

> Change set up

Buzzer Level

> More

Change set up

Technician

Code

XXX

5. Scroll to "Time Option" and press .

6. Press or , to turn Time Option ON.

7. Press twice.

If the previous program was not completed, the pump disaplys the following screen:

Do one of the following:  To resume this program, press . The accumulation screen will dispaly the remaining

Volume.

 To restart the program and /or set new parameters press and continue as follows:

10.

The screen displays the last set volume. Do one of the following:

 Press to confirm the existing parameters.  Enter the desired volume using the numeric keypad and

press .



NOTE: The screen will be blank upon initial setup.

11.

The screen displays the last set total time. Do one of the following:

 Press to confirm the existing parameters.  Enter the desired total time using the numeric keypad

using the format HH:MM (for example, enter 0-2-0-0 for two hours) and press .



NOTE: First two digits represent hours and last two digits represent minutes. Use digital

point to move from hours to minutes.

12.

The pump calculates the rate based on the time and volume entered, the accumulation screen is then displayed. Do one of the following:

 Press to confirm the existing parameters and start infusion or enter delay time, if applicable. For further information regarding delay option – refer to delay program section.

 Press to go back to volume setting screen.

Operation Led

> Time Option

Delay Before Start

Volume 500 ml

Total Time 2:00

Resume Press OK

Repeat Press NO

13.

During program operation pump displays the time left for the current program in each channel. The charger will display operation rate on each channel.



NOTE: If one of the values is changed during the programming mode, the pump will not recall

the new value, unless changes are confirmed by pressing .

If prime procedure is activated during data setting, the pump will return to the original (previous) screen, once priming has completed.



NOTE: Whenever required to stop infusion, press . Stop displayed on screen. Stop

mode is limited for two minutes. After two minutes alarm is sounded. Press to mute.

The specific channel will show the rate on the charger’s display.

Bolus During Continuous Operation

The pump allows additional Bolus dose during Continuous operation.

1. Press on .

2. Set Bolus volume and press to start Bolus infusion.

3. After bolus is completed, the pump will return to Basic program.

4. User can stop the bolus infusion at any time by pressing

Clinical Bolus

Volume 5 ml Press OK to start

Volume 5ml

2.5

4-Operation – Intermittent Infusion

TPN Infusion

Total Parenteral Nutrition - This mode delivers an infusion while automatically tapering up and down. The pattern of the program is a trapezoid.

Rate TPN Trapezoid Program

Time

On a TPN Program the operator may set the total volume which corresponds to the size of the bag to be infused, the total time, and the up and down time. Program operation will start from 2 ml/h and will increase to the maximal rate. During the flat session (T2) the rate will not change. During the last part of the program (T3), the program will start to decrease the infusion rate according to the set taper down time.

Up and down time can be set to zero. A TPN program with up and down time set to zero, is a continuous program.



NOTE: Before operating the pump in TPN program, make sure that the IV bag contains an

additional 5 ml to total volume to be infused. This ensures adequate volume for KVO during End Program. If Delay Before Start is set, you must include enough volume for the delay period in addition to the 5 ml KVO volume.

1. Turn the pump on by pressing and holding the until the self-test screen appears. The

pump display will show channel 1 and the selected program. Press to display the first TPN screen – “Total Volume”.

T1 T2 T3

Max Rate

T1 = Time UP T2= Time FLAT

4-Operation – Intermittent Infusion

2. Press . Wait for the Volume screen to display.



NOTE: If pump is not already in TPN Program refer to changing program section for

instructions.



NOTE: Whenever you decide to set a new program, follow instructions at the bottom of each

screen.

If the previous program was not completed, the pump disaplys the following screen:

Do one of the following:  To resume this program, press . The accumulation screen dispalys. The Volume

remaining will be infused.

 To restart the program and /or set new parameters press and continue as follows:

Pump displays the last set volume (volume for the TPN bag). Do one of the following:

 Press to confirm the existing parameters.

 Enter the desired volume using the numeric keypad and

press .



NOTE: The screen will be blank upon initial setup.

The screen displays the last set time (total time for the program to run). Press to confirm the existing

parameters or enter the desired time using the numeric keys and press .



NOTE: First two digits represent hours and last two digits represent minutes in the format

HH:MM (for example, enter 0-2-0-0 for 2 hr.). Use digital point to move from hours to minutes.

The screen displays the time for rate to taper up. Press to confirm the existing parameters or enter the desired value (up to 4:15 h) and press .

Channel 1

TPN PROGRAM

Total volume

__ml

Resume Press OK

Repeat Press NO

Volume 1500 ml

Total Time 12:30

Up Time 01:00

4-Operation – Intermittent Infusion

The screen displays the time for rate to taper down. Press to confirm the existing parameters or enter the desired value (up to 4:15 h) and press .

The pump calculates the set data and displays the accumulation screen, including the maximal rate for the program (to be infused during flat period). Do one of the following:

 Press to confirm the existing parameters and

start infusion or enter delay time, ifapplicable. For further information regarding delay option – refer to delay program

10.

During program operation pump displays the time left for the current program and program direction (Up/Flat/Down).

Early Taper Down

If the program must be interrupted early, and the planned taper down time must commence immediately, do as follows:

During TPN program press Stop/NO key the display will show STOP.

Press continually (2 sec) to stop the pump operation and display Taper Down screen.

Do one of the following:

 Press to start the taper down process immediately with the existing parameters.

 Set time for taper down, using numeric keys and press to start the taper down process.



NOTE: Pressing from taper down screen will start the taper down process

immediately.



NOTE: If one of the values is changed during the programming mode, the pump will not recall

the new value, unless changes are confirmed by pressing . If prime procedure is activated during data setting, the pump will return to the original (previous) screen, once priming has completed.

Down Time 0:30

Volume 1500 ml Maximal Rate: 127 ml/h Press OK to start

U Rate P

Taper Down: 0:30

Press OK key

4-Operation – Intermittent Infusion



NOTE: Whenever required to stop infusion, press . Stop message is then displayed

on the screen. Stop mode is limited for two minutes. After two minutes an audible alarm sounds. Press again to mute the alarm.



NOTE: During programming you may backspace by using :

Pressing STOP/NO once clears the last entered digit. Pressing STOP/NO again clears the next number. Pressing STOP/NO when the value is empty displays the original value or the previous screnn.

NOTE: user may set TPN PROGRAMS on both channels.

Setting Down Occlusion

1. Turn the pump on by pressing and holding the until the self-test screen appears.

Pump displays channel 1 and the program selected. Press . Wait for the Rate screen to display.

3. Press twice.

4. Scroll to "Change set up", then press .

5. Scroll to "Pressure Level" and press .

6. Press or to adjust the level (high, normal,

low).

7. Press to store the parameter in memory.

Volume Infused

View set up

> Change set up

Change set up:

> Pressure Level

Buzzer Level

Pressure Setting

High 10 psi

Adjust ↑↓ & press OK

4-Operation – Intermittent Infusion



NOTE:

 The following pressure parameters can be set:

 Low - 5 psi (0.3 bar)  Normal - 7.5 psi (0.5 bar)  High - 10 psi (0.7 bar)

 The selected pressure level will remain in memory until it is changed or the pump is

turned off.

 In the event a down occlusion situation occurs, the patient is protected by an anti-bolus

feature, which prevents bolus delivery to the patient when the downstream occlusion is released.

 When turning the pump on, the pressure default will be recalled and not the pressure

level.

 After down stream occlusion, infusion will restart from the stop point.

Program Delay

The option to delay the program before start can be set in Continuous program, TPN and 25 steps programs.

Turning the delay option ON:

1. Press twice from STOP or settings mode.

2. Scroll to "Change set up" option. Press .

3. Scroll to "More" and press .

4. Enter code 901, using the numeric keypad and press .

Volume Infused

View set up

Change set up

Buzzer Level

> More

Change set up

Technician

Code

901

4-Operation – Intermittent Infusion

5. Scroll to select “delay before start” and press .

6. Turn delay option ON by pressing or .

7. Press and the screen displays Restart Pump

8. Press to continue.

Setting delay befor start

After setting the program data pump enables setting the delay (if applicable).

Use numeric kepad to set delay time (up to 20 hours).



NOTE: pressing without setting delay time will start infusion immediately.

During delay time, pump will operate in KVO mode. Time left will count down until 00:00.



NOTE: After delay time infusion will start automatically.

Dose Program

The Dose program is the second program in the BodyGuard software, behind the Continuous program. Programming the pump using ml/hr in Continuous mode is a standard default setting, yet an operator is able to quickly select the Dose program in the event that this mode is desired.

The ability to program and adjust medication administration based on dose (mcg/kg/min), and not only flow rate, provides flexibility for the medical staff and a higher level of safety and care for the patient.

Operating the Dose Program

After power on and Self Test the following screen is appears:

Time option

> Delay before start

Language

Volume 456 ml Press OK for delay

C Continuous O Program N Press No to Change

4-Operation – Intermittent Infusion

Press and hold the Stop/No key to enable the program

selection menu. Use one of the arrow keys to scroll to Dose option and press Start/OK.

In the following four screens the user will have to set the

patient’s weight, the concentration of the drug, the actual

dose, and the volume to be delivered. The first three are the parameters required to calculate the flow rate in ml/hr. Use



NOTE: Patient Weight is configurable from 0.1 to 250 kg

in 0.1 kg increments.



NOTE: Concentration is configurable from 0.1 to 1000

mg/ml.:



NOTE: Dose is configurable from 0.1 to 999 mcg/kg/min.

To program in mg/kg/min, press Stop/No while the cursor is blank, and the screen will display the following:



NOTE: At this point, if the rate calculated by the pump is outside the pump’s flow rate range,

which will be .1 to 1200 ml/hr, the pump will deny the user from proceeding to the next screen.



NOTE: As a safety feature, especially in pediatric care, the pump can be configured to have

a Flow Rate Limit option in the Adjust Settings menu. The operator can set the rate so that under no circumstances can any infusion be programmed over 100 ml/hr, for example.

NOTE: Volume is configurable from 0.1 to 9999 ml (0.1

increments to 99.9 ml, and 1 ml increments from 100 to 9999 ml.)

After inserting the patient’s weight, drug concentration, dose, and volume to be delivered, two confirmation screens are displayed. The rate, displayed on the second screen, is a confirmation number, which is a result of all data parameters (Note: 6ml/hr is the flow rate calculated by the

pump based on the input parameters).

Press Start/OK to confirm and start the infusion, or Stop/No to return to the previous screens and change the

input parameters.

Continuous

 Dose

D Patient weight? O 10 kg S E Press OK for Conc.

D Weight 10 kg O Conc 10 mg/ml

S Dose 100 mcg/kg/min

E Press OK to Continue

D Volume 60 ml O Rate 6 ml/hr S E Press OK to Start Infusion

D Volume? O 60 ml S E Press OK to Review

D Concentration?

O 10 mg/ml

S E Press OK for Dose

D Dose? O 100 mcg/kg/min S E Press OK for Volume

4-Operation – Intermittent Infusion

After pressing Start/OK, the pump would begin the infusion

and would display the screen below. The LED would blink green and the battery icon would be displayed on the right side of the display screen.



NOTE: Pressing the “Info” key during the infusion will display the following:

 Volume Infused (in ml)  Battery Level  Concentration (in mg/ml)  Tube Temperature  Time Left  Actual pressure in psi, that is a bar starting from 0 to 10 showing the actual pressure

Dose Adjustment: The pump allows dose changing during infusion. Use numeric keys to set

the new dose value and press Start/OK within 10 seconds. The pump will briefly alarm and the infusion will resume at the adjusted dose. For example, the infusion below is running at 100 mcg/kg/min. If the operator wishes to change to 200 mcg/kg/min, he would press “200”, and press Start/OK within 10 seconds. The second screen below would then be displayed. Note that the pump displays the new dose and the new flow rate.

Before Change:

After Change:

Bolus operation: In order to program a bolus during the infusion, perform the following steps:

o Press the orange key containing a syringe (this key operates the priming function prior

to programming an infusion and when the pump activates the “Air in Line” alarm).

o The screen will appear as indicated below. Use numeric keys to set the volume of the

bolus.



NOTE: Bolus volume is configurable from 0.1 to 99.9 ml in

0.1 increments

Dose 100 mcg/kg/min

Weight 10 kg

Rate 6 ml/hr

Dose 200 mcg/kg/min

Weight 10 kg

Bolus Volume?

____ ml

Dose 100 mcg/kg/min

Weight 10 kg

4-Operation – Intermittent Infusion



NOTE: As a safety feature, especially in pediatric hospitals, the pump can be configured to

have a Max. Bolus Limit option in the Adjust Settings menu.

NOTE: The rate at which the bolus is infused is configurable in the Adjust Settings menu –

it will not be adjustable every time a bolus is initiated.

o After programming the Bolus Volume, press Start/OK

within ten seconds to initiate the bolus. (If the Start/OK is not pressed the infusion will remain at the normal rate.) Upon pressing Start/OK within ten seconds, an audible alarm would sound and the following screen would be presented, which shows the progression of the bolus injection. After the bolus is completed, the screen would revert back to the normal infusion screen (see Step 5). At any time, user can press Stop/No to stop the bolus injection.

Intermittent Infusion (Optional)

The Intermittent Infusion program is a special program which enables the design of a dose delivery protocol at set intervals. Each dose is given at a set time. The pump will “Keep Vein Open” between the doses. The infusion program continues until the total volume to be infused is delivered.

Rate over Volume

1. Turn the pump on by pressing and holding the until the Self-Test screen appears.

If air sensor is off, please contact your technician in order to enable the air sensor. 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.

Pump displays program name.



NOTE: When pump is in lock out mode, parameters can be viewed, but cannot be changed.



NOTE: If pump is not already in Intermittent Program, refer to Changing Program section.



NOTE: Whenever you decide to set a new program, follow instructions at the bottom of screen.

Channel I

Intermit

Bolus Running

Press No to Stop

4-Operation – Intermittent Infusion



NOTE: When returning to a program, the screen will display the last set program.

Bag Volume Screen

Do one of the following:

 Press to confirm the existing parameters.  Enter the Bag Volume and press .

Dose Volume Screen

Do one of the following:

 Press to confirm the existing parameters.  Enter the Dose Volume and press .

Dose Rate Screen

Do one of the following:

 Press to confirm the existing parameters  Enter the Dose Rate and press .



Interval Time Screen

Do one of the following:

 Press to confirm the existing parameters  Enter the time between the each dose and press .

NOTE: Interval time is counted from starting time of

KVO Rate Screen

Do one of the following:

 Press to confirm the existing parameters  Enter desired KVO rate (from .1 to 5 ml/h), press .

Accumulation Screen

Do one of the following:  Press to confirm the existing parameters and

start infusion.

 Press to go back and adjust program parameters.

Interval Time: __:__

Enter & press OK

Dose Vol: 200 ml/h Dose Rate 200 ml/h Interval Time 1:00 KVO Rate 0.2ml/h

KVO Rate: __ ml/h

Enter & press OK

Dose Rate: ___ ml/h

Enter & press OK

Dose Vol: ___ ml

Enter & press OK

Bag Vol: 200 ml/h VolumeLeft 200 ml/h Infused 1:00 Press OK to continue

Bag Vol: ___ ml

Enter & press OK

4-Operation – Intermittent Infusion



NOTE: If pump is in Delay Mode, enter Start Time (24 Hour Clock) and Start Date. For further

information regarding the Delay Option, refer to Delay Program section.

9. Press to Start Infusion. Delay time option is

disablde, screen will show start time as “Immediate”.

10.

During program operation, the pump displays the rate in which the program is operating.



NOTE: If one of the values is changed during the programming mode, the pump will not recall

the new value unless changes are confirmed by pressing .

NOTE: If prime procedure is activated during data setting, the pump will return to the original

(previous) screen once priming has completed.



NOTE: Whenever required to stop infusion, press . Stop displays on the screen. Stop

mode is limited to two minutes. After two minutes an audible alarm sounds. Press

again to mute the alarm or press STOP/NO until the pump powers off.

Rate Adjustment

It is necessary to stop infusion in order to change any or all parameters of the current infusion program

To change the rate while in Stop mode:

1. Press any number on the keypad and then press .

2. Adjust the rate and press .

3. Adjust all other parameters and press to restart infusion.

Next Dose Start Time: Immediate Press OK to start

Rate

25 ml/h

4-Operation – Intermittent Infusion



NOTE: During programming, you may backspace by using :

Pressing once clears the last entered digit. Pressing again clears the next number. Pressing when the value is empty displays the original value or the previous screen.

Resume Infusion, Start New Bag, or Reprogram Infusion

When an Intermittent infusion is stopped and the pump is re-started, the operator has the following options:

(1) Resume: Resume the original infusion exactly where it left off (2) New Bag: Resume the original infusion with a new bag (3) Repeat: Repeat or re-program the infusion

Intermittent Stop Screen

Press or to scroll to the appropriate selection and press .

Resume – New Bag – Reprogram Screen

Display shows a summary of the current infusion to be started. User can scroll through the details by pressing

or . Press to start infusion.

R E S

Resume New Bag Repeat

Dose Rate 100 ml/h Dose Vol. 100 ml Pause 5:00 Press OK to start

I N T R

4-Operation – Intermittent Infusion

Program Delay

The option to Delay Program Before Start can only be used in the Intermittent Mode.

Turning the Delay Option ON

Press twice from STOP or setting mode.

Warning: If air sensor is off, please contact your technician in order to enable the air sensor. 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.

Scroll to "Change Set up" option and press .

Scroll to "More …" and press .

Enter Change Set up level 1 code, using the numeric keyboard and press .

Volume Infused Review Set up

Change Set up

Buzzer Level

More …

Change Set up:

Code Technician

XXX

4-Operation – Intermittent Infusion

Scroll to "Delay Before Start" option and press .

Turn delay option ON by pressing or .

Press and the screen displays Restart Pump

Press to continue.

Setting the Time for “Delay Before Start”

After entering the program data, the pump enables setting the Delay Before Start time (when Delay Before Start is turned ON).



NOTE: The delay time format is a 24 hour clock. This means that hours are viewed as follows

10:00, 11:00, 12:00, 13:00, 14:00, 15:00 etc.



NOTE: The pump automatically displays the current time and date. To start pump

immediately, press to confirm the existing time and date and start infusion.



NOTE: If the time and/or date automatically displayed by the pump are incorrect, go to the

Settings Menu and select “Set Time & Date” to reset the clock in the pump.

Start Time Screen

To change the Start Time, type the desired start time using the numeric keypad and press . To start pump immediately, do not change the time and press .



NOTE: To start pump at 9:30 AM, enter 0-9-3-0. To start the pump at 9:30 PM, enter 2-1-3-0.

Start Date Screen

To change the Start Date, type the desired start date using the numeric keypad and press . To start pump on

the same day, do not change the date and press .

Start Date __/__/__

Press OK key

D E

Start Time __:__

Press OK key

Time Option

Delay Before Start

Language

D E

4-Operation – Intermittent Infusion

KVO During Delay Screen

During delay time, pump will operate in KVO mode. Time left will count down until 00:00 and will then automatically start the progrmamed infusion. During the delay, this screen will be displayed showing when the infusion will start.



NOTE: After delay time, pump will beep once then infusion will start automatically.

Turning Pump Off During an Intermittent Infusion

When the pump is turned off during an intermittent infusion, the internal clock in the pump will continue to monitor the timing of the infusion. If the pump is stopped during a dose, the operator will be able to resume the dose if the infusion is resumed before one third of the interval time has elapsed. For example, if the interval is 3 hours, then the operator can restart the infusion within 1 hour, the remainder of the dose will be administered as well as the future scheduled doses. If the operator restarts the infusion after one third of the interval time has elapsed, the operator will not receive the remainder of the dose. The pump will automatically begin KVO until the next scheduled dose. The purpose of this “One Third” rule is to allow the operator to turn their pump off during a dose without changing the scheduled dose times.

If the pump is turned off during a dose and restarted after the next scheduled dose time has passed, then the pump will start that the next dose immediately from the beginning followed by a

complete interval as set by the operator. For example, if the patient restarts the infusion an hour past the scheduled dose time, then the patient will receive a complete dose followed by a complete interval.

If the pump is turned off during the interval period, the patient can restart the pump anytime before the next scheduled dose without impacting the timing of the delivery of the next dose. If the pump is not restarted until after the next scheduled dose was scheduled, then the pump will start the next dose immediately followed by a complete interval.

4/ 8/2005 12:05 Start Time 18:30 Start Date 04/08/05 Press OK to Start

D E L A

25 Steps Protocol (Optional)

This protocol permits programming of up to twenty-five different steps. Each step has its own rate and volume. Step accumulation is limited to a Volume of ten (10) liters. Protocol steps are delivered sequentially until all steps are completed.



NOTE: Before operating the pump in 25 Steps Protocol, make sure that the IV bag contains an

additional 5 ml of total volume to be infused. This assures adequate volume for KVO during End Program. If Delay Before Start is set, you must include enough volume for the delay period, as well as the post program period.

1. Turn the pump on by pressing and holding the until the Self-Test screen appears.

Warning: If air sensor is OFF, please contact your technician in order to enable the air sensor. 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.

Pump displays program name.



NOTE: If pump is not already in 25 Steps Protocol, refer to changing program section for

instructions.



NOTE: Whenever you decide to set a new program, follow instructions at the bottom of screen.



NOTE: The screen will be blank upon initial setup.

Rate Screen – Step 1

Do one of the following:

 Press to confirm the existing parameters.

 Enter the desired rate and press .

Volume Screen – Step 1

Do one of the following:

 Press to confirm the existing parameters.  Enter the desired volume and press .

Step 1 Volume

___ ml

Step 1 Rate

___ ml/h

25 - Steps

Program

Press NO to Change

Rate Screen – Step 2

Pump displays the rate for step 2. Repeat the same instructions for step 1 and repeat until the required number

After entering the last required step, press without entering a rate.

This indicates that all required data has been set. All



NOTE: If pump is in Delay Mode, enter KVO rate.

Accumulation Screen

Do one of the following:

 Press to confirm the existing parameters.  Press to go back to rate setting screen.



NOTE: If pump is in Delay Mode, enter Start Time (24 Hour Clock) and Start Date. For further

information regarding the Delay Option, refer to Delay Program section.

8. Press to Start Infusion.

During program operation, the display identifies which step is currently running, as well as the rate.



NOTE: If one of the values is changed during the programming mode, the pump will not recall

the new value unless changes are confirmed by pressing .

If prime procedure is activated during data setting, the pump will return to the original (previous) screen once priming has completed.



NOTE: Whenever required to stop infusion, press . Stop displays on the screen. Stop

mode is limited to two minutes. After two minutes an audible alarm sounds. Press again to mute the alarm.



NOTE: During programming you may backspace by using

Pressing once clears the last entered digit. Pressing again clears the next number. Pressing when the value is empty displays the original value or the previous screen.

Rate Step 1 of 5

25 ml/h

Start Infusion?

Steps Total 5

Volume Total 500 ml

Step 5 Rate

___ ml/h

Step 2 Rate

___ ml/h

PCA Infusion (Optional)

Patient Control Analgesia is a program used for patients who require IV pain management or epidural analgesia. Pain management is administered through a continuous basal rate, in combination with preprogrammed boluses. The pump will deliver only the boluses corresponding to the preset time intervals. All bolus features are stored in the pump memory. The physician can read these statistics and adjust the settings as needed.

Warning: 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.

PCA Menu

Due to the sensitive nature of PCA infusion, the BodyGuard 323 offers a specific menu to enhance the operator’s experience while programming PCA infusions. The menu organizes the infusion information

centrally while maintaining the same programming format as the other infusion modes of the pump.

Turn the pump on by pressing the until the Self-Test screen appears.

Warning: If air sensor is off, please contact your technician in order to enable the air sensor.

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.

Pump displays program name. Press . If the pump is unlocked, the PCA Menu will

display. If the pump is locked, enter the “Unlock Program Code



NOTE: The PCA program automatically locks upon completion of programming.



NOTE: If pump is not already in PCA Program refer to Changing Program section for instructions.



NOTE: Whenever you decide to set a new program, follow instructions at the bottom of each

screen.

Channel I

PCA

P C A

Unlock Program Code

Enter & press OK

Priming



NOTE: Priming is disabled during PCA operation. Always prime the set before starting a

program.

Warning: Always disconnect IV tubing from patient before starting the priming procedure.

Selecting the Prime option from the PCA menu, the screen will show the priming screen.

Press OK to program priming procedure.

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

3. Enter the volume to prime the set and press to

begin priming procedure. You may stop priming at any time by pressing .

The display screen will show a graph indicating the prime operation.

Once the priming has completed, the display will change back to the previous screen the pump

Program Infusion

Volume Screen

Enter the infusion Volume and press .

Rate Screen Enter the Rate in ml/hr and press or follow

step 3 to change to concentration format.

Rate/Concentration Selection Screen  To program Concentration in Milligrams per Milliliter

(mg/ml), press once.

 To program Concentration in Micrograms per Milliliter

(mµ/ml), press once again.

ml/hr

Press OK to Continue

Volume ml





Prime Vol __ ml

PRIME 5 ml

Prime

Program Infusion Clinician Bolus

Rate ml

Rate or Concentration Screen Do one of the following:

 Press to confirm the existing parameters.  Enter the desired rate or concentration and press .



NOTE: To change from Concentration back to Rate, enter 0 (zero) for Concentration and

press .

Concentration Rate Screen

(Only When using Concentration Format)

Do one of the following:

 Press to confirm the existing parameters.  Enter the desired rate or concentration and press .

Bolus Screen

Do one of the following (Bolus can be ml, mg, or mcg depending on the program selected):

 Press to confirm the existing parameters.  Enter the desired bolus dose and press .

Lock Time Screen

The lock time is the amount of time between patient boluses. Do one of the following:

 Press to confirm the existing parameters.  Enter the desired lock time in minutes and press .

Limit in XXX Hours

To enable this feature go to the Change Set up menu and set a time limit (window), then press . In the

following screen choose either the amount of max “Dose at

Time Window” or the max Boluses Number during the time

limit. Once Limit has been set, the screen on the right will appear while programming a PCA program. Set the limit (in volume) to be administered during the preset timeframe.

P C A

Rate ___ mg/h

Adjust & press OK

Concentration ___ micrograms/ml

Lock Out __ min

Enter & press OK

P C A

Bolus Vol. __ ml

Press OK to Continue

Concentration

___ mg/ml

Rate ___ ml/h

Adjust & press OK

Limit in 2 Hours

__ml

Enter & press OK

Locking Screen

The pump automatically locks before a PCA infusion program can be completed. Do one of the following:

 Press to lock the PCA program and proceed.  Press to scroll through and review the program or

10.

Accumulation Screens

The pump displays the accumulation screen with a summary the program entered. User can scroll through the entire

program by pressing or . Do one of the following:

 Press to confirm parameters and proceed..  Press to go back and adjust parameters.



NOTE: Operator can confirm that pump is infusing by checking that the LED light is blinking

green on the pump and that a spinning logo is showing on the charger display.



NOTE: LED indicator can be turned off in the main settings menu to save battery power.



NOTE: The BodyGuard is capable of continuous infusion (basal) rates of up to 100 ml/h.

However you may use the pump for the delivery of only one drug protocol and the maximum safe ceiling for this regime could be, for example, 30ml/h. operators can set a maximum rate in ‘Change Set Up’ using the Technician Access Code to assure other operators do not accidentally program the pump to deliver above a preset ceiling. See section for ‘Change Set Up’.



NOTE: The BodyGuard is capable of delivering the bolus dose at up to 1000ml/h. The default

setting of 600ml/h is designed to deliver any bolus at an optimal speed. The operator can adjust the bolus to be delivered over a shorter/longer period in ‘Change Set Up’ using the Technician Access code.

P C

Bag Vol: 200 ml Vol. Left 200 ml Infused 0ml Press OK to start

Rate ml/hr Bolus Vol: ml

Bolus Rate ml/hr Lock Out: Min

Lock: Press OK

Review: Press NO

Interpreting the Display Screen During PCA Infusion

Infusion Rate

The first line of the display shows the current infusion rate. Depending if the operator programmed the current protocol in ml/hr, mg/ml/hr or mcg/ml/hr this line will display the current format being used.

Bolus Volume

When administering a bolus dose using Prime/Bolus button, the bolus volume is displayed in place of the infusion rate screen until the bolus is completed. As with infusion rate, the bolus format will be displayed in ml/hr, mg/hr or mcg/hr depending on how the current program is set up.

Battery Status

In the right hand margin, you can see the battery and infusion status indicator. The battery symbol will be visible when the pump is not connected to the mains charger. Operator can check the charge level by monitoring the black fill inside the symbol (i.e. completely black symbol indicates a fully charged battery).

Patient Activated Bolus

A PCA infusion can (optionally) be programmed to allow the patient to request boluses of a specified volume within predetermined time intervals. The patient can request the bolus by one of the following two methods:

Using Bolus Cable – Assuming Pump is Equipped with Bolus Connection + Cable

Press the button on the end of the bolus cable. The bolus cable plugs into the side of the pump

where a label reads “Bolus”



NOTE: Administering boluses via a bolus cable is dependent on a bolus connection and cable.

Not all BodyGuard 121 Twins are equipped with such devices.

Using Keypad

Press the button on the keypad.

Rate 2.5 ml/h

Bolus 5 ml

Programmed

Infusion Rate

(ml/hr or mg/ml)

Patient

Controlled

Bolus Volume



NOTE: User can stop a bolus at any time by pressing



NOTE: If patient requests more boluses than are allowed, the pump will display “Bolus Locked”

and will continue to track the amount of boluses requested by the operator. The bolus history can be reviewed by a physician/clinician by scrolling the Info Menu. See “Using History Functions” section of the manual.

Clinician Activated Bolus

A Clinician Activated Bolus can be performed before starting the PCA infusion or during the PCA infusion.

To infuse a Clinician Activated Bolus before starting the PCA infusion, perform the following steps:

1. From one of the program parameter screens, Press the button.

2. Enter Priming Code and press .

3. Enter the volume of the Clinician Bolus and press to begin priming procedure. You may

stop the bolus at any time by pressing .

The Volume for the Bolus will be in ml, mg or µg depending on the settings of the existing protocol entered for the PCA infusion. To change, go to Program Infusion in the PCA menu and follow the steps until the selection can be made for ml, mg or µg.

The display screen will show a bar indicating the Bolus is being infused. The progress bar displays the amount of the bolus to be infused (clear) and the amount infused (dark).



Once the bolus is completed, the display will change back to the PCA menu.



User can stop a bolus at any time by pressing

Warning: Boluses will be infused up to the full volume that is requested unless the operator

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.

Priming Code

XXX

Volume 5 ml

0 4.1 5

B O

L U S

To infuse a Clinician Activated Bolus during a PCA infusion, perform the following steps:

1. During operation, press and then press to

stop the current infusion and initiate the Clinician Bolus.

2. Enter Level 2 Technician Code and press .

3. Enter the volume of the Clinician Bolus and press

to begin priming procedure. You may stop the bolus at any time by pressing .

The Volume for the Bolus will be in ml, mg or µg depending on the settings of the existing protocol set up for the PCA infusion.

The display screen will show a graph indicating the Bolus is being infused. The graphical bar displays the amount of the bolus to be infused (clear) and the amount infused (dark).



Once the bolus is completed, the pump will resume the original PCA infusion.



operator can stop bolus at any time by pressing

End of Infusion, Restart Infusion, or Bag Change

End Infusion Screen

Once infusion has reached its end (pre-set volume was infused), an alarm sounds and the display will show:

KVO Display The alarm will stop after 4 beeps. The pump will show the pre-set KVO rate. The alarm will sound again every 4 minutes until the user changes the bag or stops the pump.

KVO 5 ml/h

End Infusion

Clinician Bolus

Volume ___ mcg

Clinician Bolus

Volume ___ ml

Clinician Bolus

Volume ___ mg

CA Bolus Code

XXX

Volume 5 ml

PCA Restart Menu This screen displays when: (1) The pump is turned OFF and back ON in PCA mode.

(2) Infusion is stopped by pressing and holding .

User can scroll through the following options by pressing

or .

 Restart – Starts infusion exactly where it left off

previously.

 New Bag – Restarts infusion exactly where it left

off previously and updates bag volume to be equal to the bag volume originally programmed.

 Unlock Program – Brings operator back to the

PCA Menu. When asked for a code, enter the Unlock Code.



NOTE: If using an infusion set with drip chamber, change to a new infusion bag, but make sure

that the drip chamber is half filled and there is no air in the administration set. If using an ambulatory IV, PCA or Epidural set without a drip chamber, priming the line may be needed.

Disconnect the set from patient before priming!!!

Return to PCA Programming Screens

PCA Restart Menu Scroll to “Menu” using and press .

2. Enter Level 1 Technician Code and press .

Unlock Program Code

XXX

P C

P C A

Resume New Bag => Unlock Program Select and press OK

=> Resume New Bag Unlock Program Select and press OK

P C A

Lock Mode

The BodyGuard provides two different levels of locking:

 Level 1: Keypad Locking

During operation all keys are disabled excluding the STOP/NO and the INFO key. During programming all keys are disabled excluding the START/OK and the INFO key.

 Level 2: Maximal Rate Locking

This feature enables the operator to set a maximal rate for the pump to accept. The program rate then can be adjusted only up to a preset limit.

How To Lock

Level 1 – Keypad locking

Press and hold until the entire bar is black and a beep is heard. The beep indicates that the locking program is turned ON.

 The keys are locked in memory until they are unlocked or

until entering Change set up mode.

To unlock the keys Press and hold until the entire graph is cleared and a beep is heard. The beep indicates that the locking program is OFF. The number one is no longer displayed in the upperright corner of the screen and the keys are unlocked.

Level 2 – Maximal Rate locking

1. Press twice from STOP or setting mode.

2. Scroll to "Change set up" option. Press .

3. Scroll to "More" and press .

Enter code 901, using the numeric keypad and press

5. Scroll to "Maximum Rate " option. Press .

Use numeric keys to set desired rate and press .

Volume Infused

View set up

Buzzer Level

> More

Technician

Code

902

Bolus Rate

> Maximum Rate

LOCK Mode

Info Mode

Access the info mode by pressing during operation, data setting or while in the Stop mode.

Pressing during program operation will display the following:

Number of

button presses

Infusion Mode

Information

Screen

All programs

Infused Volume

Total Volume to Be Infused

All programs

Battery Status

TPN

Program Status in a graphic illustration

Continuous/ Dose/PCA

Time remaining for the end of the program

3 25 Steps

Time and Date

Cont/TPN/ Dose/PCA

Time and Date

25 Steps

Actual Pressure

Cont/TPN/ Dose/PCA

Actual Pressure

Pressing during data setting or in the stop mode, will display the following:

Infused Battery Level

Time

Time Left XXX ml/h

Time HH:MM Date DD.MM.YY

Number of

button presses

Information

Screen

One

Infused Volume

Total Volume to Be Infused

Pressing STOP/NO will clear Volume Infused.

Two

Option Selection screen

To change parameters, select Change set up, press Start/OK anf follow instructions in the Change set up section.

To view current pump settings, select Review set up, press Start/OK and follow instruction in View set up section.



NOTE:

 If no selection is made within ten seconds after pressing , the screen will exit the

information mode and display the previous screen.

 To exit the information mode after making a selection in Review set up, press once

to return to the original screen.

 To exit the information mode after making a selection in Change set up, press .  Depending on software version, Info button may display slightly different data.

Volume Infused

Review set up

Infused

Review set up

The Review set up feature is designed to allow you to view the programmable options and other important information about the pump. In View set up, the current setting can be viewed, but cannot be changed.

Press twice.

Press to scroll to "Review set up" option. Press and the current settings are displayed, but cannot be changed.

To view the setting for a particular option, select the desired

option and press .

Screen No.

Screen Display

Information

Battery Level

Current battery level (Empty >>> Full)

Display Time and Date

Time and date

Show Power Voltage

Battery and power specifications

Buzzer Level

Current buzzer volume setting

Pressure Level

Current pressure level setting

Pressure Defaults

Current pressure default setting

Select Program

Current Slected Program

Volume Option

Option currently ON or OFF

Priming Volume

Current Priming volume setting

Priming Rate

Current rate of priming procedure

Maximum Bolus Volume

Maximal Bolus Volume

Bolus Rate

Current bolus rate setting

Maximal Rate

Current maximal rate setting

KVO Rate

Current KVO rate setting

Flow Control

View set up:

> Battery Level

Volume Infused

> Review set up

Air-in-Line-Limit

Current air bubble size setting

Operation LED

Option currently ON or OFF

Time option

Option currently ON or OFF

Delay before start

Option currently ON or OFF

Language

Current pump messages language

Serial Number

Pump Serial Number

Production Date

Pump production date

Operation time

Hours since last Service Calibration

Software Version

Pump Software Version

Volume Calibration

Volumetric Calibration value

Pressure Delta

Pressure Calibration – Delta value

Pressure CAP

Pressure Calibration – Cap value

EXIT

Change Set up

The “Change Set up” mode allows you to make changes to various parameters.

To access Change Set up:

1. Press twice.

2. Scroll to "Change set up" option. Press .

To adjust Pressure Level or Buzzer Level:

1. Press or to select an option and press

2. Make adjustment by pressing or and press .

To adjust other parameters:

. Scroll to select "More" and press .

2. Use numeric keypad to enter Code 901 and press .

3. Scroll to select a desired parameter and press .

4. Adjust the parameter by pressing or or by using the numeric keypad.

5. Press and the screen displays Restart Pump.

6. Press to continue.

Volume Infused

Review set up

Buzzer Level

> More

Change set up:

> Pressure Level

The table below indicates the adjustable parameters

Screen No.

Screen Information

Action

Pressure Level

Choose pressure level (High 10 psi, Normal 7.5 psi, Low 5 psi).

Buzzer Level

Adjust the buzzer level. Note: the buzzer cannot be muted for safety reasons.

3 Code 901

Restart pump

Pressure Default

Select pressure default (High 10 psi, Normal 7.5 psi, Low 5 psi).

Select Program

Select the infusion program

Volume Option

ON by Default. Can be turned OFF in some modes to enable operator to work indefinitely until operator stops or changes the it.

Priming Volume

Set the priming volume from 0-60 ml.

Priming Rate

Optimal: 600ml/h (adjustable up to 1200ml/h)

Max. Bolus Volume

Set the Max. bolus volume from 0-100 ml.

BOLUS rate

Set the bolus rate from 0-1200 ml/hr.

Maximal Rate

Set the maximal rate from 0.1-1200 ml/hr

KVO rate

Set the KVO rate from 0.1-5.0 ml/hr

PCA Limit Setting

Set a time window in which a limit of drug administration can be set.

Flow Control

0-20 drops per ml.

Air-in-Line Limit

Set detectable air bubble size from 0.1-1.0 ml.

Operation led

Turn operation led ON/OFF

Time option

Turn time option ON/OFF. While time option is ON, continuous program will be set to Volume over Time.

Delay before start

Turn option ON/OFF

Language

Enable changing the language of pump messages (only for models, in which the softwae includes more than one language).

Set Time & Date

Set actual time and date.

Event Log Channel I

Indicates injection history.

Event Log Channel II

Indicates injection history.

Restart Pump

Reboots the Pump and returns to openning screen.



NOTE: While the pump is in programmable mode, all parameters can be set, or parameters

used in last program can be confirmed. The memory hold capability is available for the life of the internal battery.

5 – Alarm State and Troubleshooting

Alarm State

When the infusion pump detects a problem, the following occurs:

 The infusion stops.

 An audible alarm sounds.

 A message appears on the display screen indicating the cause of the alarm, and:

 The LED indicator will change from green to red.



NOTE: Pressing during an alarm, mutes the alarm for two minutes.

The conditions listed in the following table activate an alarm:

Troubleshooting (on the relevant channel)

Description

Result

Possible Cause

Required Action

Air in Line

Infusion stops and an alarm is activated.

The operation led for the relevant channel will blink red.

The Charger display will show: “AIR”

Air is present in administration set.

The roller or clip on the administration set is closed upstream of the pump.

The line was not loaded correctly.

Disconnect line from patient, press STOP/NO. Remove the air, as described on priming section.

Open clamp/clip.

Re-load the IV line.

Down occlusion

Infusion stops and an alarm is activated.

The operation led for the relevant channel will blink red.

The charger display will show:

“PRES” for Pressure

The roller or clip on the administration set is closed downstream of the pump.

Administration set is kinked

Cannula is blocked

Administration set loaded incorrectly

NOTE: operator may change pressure setting.

Open clamp/clip.

Straighten the Set.

Change or clear the Cannula

Re-load the IV line

Refer to Setting Down Occlusion

Pump Unattended

Alarm is activated

The operation led for the relevant channel will blink red.

Two minutes had elapsed without pressing a button

Pump left in STOP state for more than two minutes

Press START/OK to resume

Air in Line

Down Occlusion

Pump Unattended

Door Open

Infusion stops and an alarm is activated.

The operation led for the relevant channel will blink red.

The door of the pump was not closed properly prior to operation.

The door has accidentally opened during operation.

Close the Door of the pump.

Low Bttery

Pump will only run for another 30 minutes if it will not be connected to mains.

30 Minutes of battery life remaining.

Place the pump in charger and connect to mains.

End Bttery

Pump operation stops. The pump cannot be used unless connected to mains.

Battery is depleted.

Place the pump in charger and connect to mains. Wait at least 2

Fatal Error

Infusion stops.

The operation led for the relevant channel will blink red.

Fatal internal error has occurred.

Restart the pump. If the alarm does not stop press Info and record the error number (if

End Program

Program ends, pump will start KVO mode automatically if enabled in settings menu.

Current infusion program has completed.

Press STOP/NO to restart a new program or turn the pump OFF.

Missing Key

Pump will not start

The operation led for the relevant channel will blink red.

Administration set loaded incorrectly.

Attempt was made to operate the pump/channel without an administration set.

Reload the set into the pump as per as instructions.

Load a set in the desired channel.

Door Open

Low Battery

End Battery

Error xx (number)

Missing Key

End Program KVO

Lock Out

Setting cannot be changed.

The operation led for the relevant channel will blink red.

Lock Out mode is turned on.

No action required. If changing program is required

– unlock the pump – refer to lock

section for further

Lock mode

Kepad does not function

The operation led for the relevant channel will blink red.

Lock mode is turned on.

No action required. If changing parameters is required – unlock the keys using Info button– refer to

Wrong TPN data

Program will not start operating.

The operation led for the relevant channel will blink red.

The set parameters are impossible to perform. Volume or time parameters are incorrect

Check data and change accordingly.

Locked

Lock Mode

Wrong TPN data

6 – Specifications

Channels

Pumping Mechanism:

Two independent channels.

Piston Pump

Flow Rate:

0.1 to 100 ml/hr in 0.1ml , 100 to 1200ml/hr in 1 ml increments.

Priming Rate:

600 ml/hr

Total Infused Volume:

0.1-9999 ml

Total Time Setting:

100 hours

Accuracy:

± 5 %.

KVO rate:

0.1 to 5 ml/hr. (to be set)

Air Sensor:

Ultrasonic, adjustable air bubble size

Maximum Pressure:

0.7 bar or 10 psi Adjustable (high/normal/low)

Power Supply:

110-240 VAC, 50/60 Hz. 0.3A max.

Battery:

Rechargeable Li-ion Polymer 7.4V, 1800mAh. (Typical)

Battery Operation at 125 ml/hr:

.5 hours

Battery Charging:

Automatic when clicked into the Charger that is connected to an AC power source. Four hours needed to charge a fully-depleted battery.

Alarms:

When a problem is detected, the BodyGuard displays the following alarms:

 Air in line  Down Occlusion  Pump Unattended  End Program  Low Battery  End Battery  Door Open  Fatal Error  Lock Mode  Lock Out Mode  Missing Key



NOTE: When this symbol is seen, consult accompanying documents.

BodyGuard Dimensions:

146 x 84 x 40mm. (L x w x h).

Classification

Type CF Equipment (degree of protection against electrical shock)

Housing:

ABS (fire retardant)

Weight

 435 gr. without battery  545 gr. with battery  460 gr pump charger

Electrical Safety

Complies with: EN 60601-1 (Medical Electrical Equipment Safety), IEC 60601-2-24 (Infusion pumps and controllers), IEC 60601-1-4 (Programmable Electrical Medical System), UL 2601- 1 and CAN/CSA C22.2 No 601.1.

Standards

Manufacture in accordance to ISO 13485. CE marked (In accordance with the Medical Devices Directive 93/42/EEC)

EMC

The BodyGuard Infusion System is designed to be in compliance with EN 60601-1 (safety) and IEC 601-1-2 (EMC).

Environmental Specifications

Non Operating Conditions (Transportation and Storage):

Temperature: -25oC to 50 oC (-13 oF to + 122 oF) Humidity: 5 % to 100% R.H., non-condensing Air pressure: 48kPa to 110kPa

Operating Conditions:

(The system may not meet all performance specifications if operated outside of the following conditions) Temperature: +15oC to +40 oC (+59 oF to + 113 oF) Humidity: 20 % to 90% R.H. at +40 oC, non-condensing Air pressure: 70kPa to 110kPa

Accessories (optional)

 Bolus cable  Charging cable  Small bag  Large back bag

7 – Service and Maintenance

Cleaning

Before connecting the pump to a patient, and periodically during use, clean the unit using a lint-free cloth lightly dampened with warm water and a mild detergent or disinfectant.

Warning: Always turn the pump off, and remove the battery before cleaning.

Warning: Always unplug the charger from AC power before cleaning.

Caution: 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 dampened with warm water and a mild detergent or disinfectant.

Caution: Do not soak or immerse any part of the pump or charger in water.

Storage

If the pump is to be stored for an extended period it should be cleaned and the battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, in its original packaging for protection.

Perform functional tests and ensure that battery is fully charged once every three months.

Battery Operation

The BodyGuard pump can operate on battery power, enabling operation when the patient is being moved or during electrical power failure. When the pump operates on battery power, the AC icon is off. At full charge, the battery provides 7.5 hours of operation at an infusion rate of 125 ml/hr.

Warning: Do not operate the pump on AC power if the battery is not loaded in the pump

for back up.



Note: When the pump is not in use, click the pump into the Charger and plug the system

into an AC wall outlet (if possible) to charge battery.



Note: After the end battery“ signal has been activated or following long periods of storage,

wait 2 minutes after the pump has been connected to an AC power supply before operating.

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

the battery.



Note: Whenever possible, use the pump connected to an AC power supply via the charging

unit. This preserves the battery power supply for emergency use or for situations where the AC power is not available.



Note: Replace the battery once every two years.

LIMITED WARRANTY

The BodyGuard Infusion Pump has been carefully manufactured from the highest quality components.

Caesarea Medical Electronics Ltd. (CME) guarantees the pump against defects in material and workmanship for twelve (12) months from date of purchase by the original purchaser.

CME’s obligation, or that of its designated representative under this Limited Warranty, shall

be limited, at CME’s option, or that of its designated representative, to repairing or replacing pumps, which upon examination, are found to be defective in material or workmanship. The repair or replacement of any product under this Limited Warranty shall not extend the abovementioned Warranty period.

All repairs under this Limited Warranty should be undertaken only by qualified, trained service personnel. In the event that a pump is found to be defective during the warranty period, the purchaser shall notify CME or its designated representative within thirty (30) days after such defect is discovered.

The defective pump should be sent immediately to CME or its designated representative for inspection, repair or replacement. Shipping costs are the purchaser’s responsibility.

Material returned to CME or its designated representative should be properly packaged using CME shipping cartons and inserts. Inadequate packaging may result in severe pump damage.

This Limited Warranty shall not apply to defects or damage caused, wholly or in part, by negligence, spilt fluids, dropping of the pump, misuse, abuse, improper installation or alteration by anyone other than qualified, trained personnel; or to damage resulting from inadequate packaging in shipping the pump to CME or its designated representative.

If, after inspection, CME or its designated representative is unable to identify a problem, CME or its designated representative reserves the right to invoice purchaser for such inspection.

This Limited Warranty is the sole and entire warranty pertaining to CME’s products and is in lieu of and excludes all other warranties of any nature whatsoever, whether stated, or implied or arising by operation of law, trade, usage or course of dealing, including but not limited to, warranties of merchantability and warranties of fitness for a particular purpose. Purchaser expressly agrees that the remedies granted to it under this limited warranty are purchaser’s sole and exclusive remedies with respect to any claim of purchaser arising under this Limited Warranty.

Managing Director

CME BodyGuard 121 Twins Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual