C-me BodyGuard 121 Twins User manual

October 2014
Ref.: 100-090TO Rev. 1.0
BodyGuard 121
Twins
Infusion System
Operator Manual
MedNet GmbH.
Borkstrasse 10
48163 Muenster
Germany
T: [phone]
Caesarea Medical Electronics Ltd.
16 Shacham street
Industrial Park Caesarea North
P.O.Box 4294 Caesarea 38900, Israel
E: [email protected]
W: www.cme-infusion.com
0344

2

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.

3
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

4
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

5
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
Infusion Rate: 0.1 to 1200 ml/hr.
Volume: 0.1 to 9999 ml.
Bolus Volume: 0-100ml
Bolus Rate: 0.1-1200 ml/hr
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

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
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)

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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
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1
3
2
5
6
4
9
8
10
7

8
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

9
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.
3.
Keyway
(Optional)
Guides the IV line
4.
Pressing
Plate
Connected to the door by two
springs.
5.
Pump door
Covers the pressing plate.
6.
Air sensor
front
Ultrasonic air detector, which is
mounted on the front housing.
7.
Air sensor -
door
Mounted on the door.
8.
Flow
Direction
Shows direction of pump
operation.
1
6
7
2
3
8
5
4

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The Charger
Led
Description
1.
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.
2.
Battery charging led
Red when the battery is empty and being charged
3.
Battery charged led
Red when the battery is fully charged
4.
Channel one charger display
Displays channel I data
5.
Channel two charger display
Displays channel II data
6.
Mains led
Red when the pump is connected to mains
7.
Channel two pump led
Green when channel II is on display, Red when channel II is
being programmed or under alarm, idle when channel I is on
display.
6
7
2
1
3
4
5

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

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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 (720F). 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.

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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.

14

15

16
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

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Warning: Indicates that the information is a warning. Warnings advise you of
circumstances that could result in injury or death to the patient or operator. Read and
understand this manual and all warnings completely before operating the BodyGuard Infusion
System.
Caution: Indicates that the information is a caution. Cautions advise you of circumstances
that could result in damage to the device. Read and understand this manual and all cautions
completely before operating the BodyGuard Infusion System.

NOTE: Indicates that the information that follows is additional important information or a tip
that will help you operating the BodyGuard Infusion System.
Intended Use
The BodyGuard 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

18
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 anesthetic-
air/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.

19
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
1.
Carefully remove the pump and Charger from the box.
2.
Make sure no items were damaged during shipment
3.
Make sure you have the following items:

BodyGuard 121 Twins Infusion Pump

Charger

Operation Manual
If any items are missing or damaged, contact your BodyGuard 121 Twins dealer.

20
Charging the Pump

NOTE: The pump is protected against overcharging. Connect the pump to the mains via the
charger whenever possible to be sure that the battery is fully charged at all times.
Warning: If the battery is damaged during operation, while pump and charger are
disconnected from mains, the pump will turn off.
1. Connect the charger unit to AC power, and verify that the AC indicator is lit (charger right side above
channel II).
2. Put the pump into the charger and tighten the safety screw. Please see drawing on the charger.
3. The battery is charging when the red battery LED on the front of the charger is lit. (charger lower left
side above channel I) The battery is fully charged when the full battery LED symbol turns red
(charger upper left side above channel I).
4. Remove the pump from the charger by releasing the safety screw and lifting the pump out of the
charger.
Caution:Leaving the battery discharged for a long period of time may damage the battery.
4 –Operation
Before Operating the Pump
Before attaching the system to a patient, run the following tests to verify that all indicators and
alarms work properly. Perform the test on both channels.
When an alarm is activated the following occurs:

An alarm message appears on the pump and charger display. Each channel has its own display.
The alarm message will be shown on the display relevant to the channel in which the alarm
occurred.

An audible alarm sounds.

Infusion ceases.

The operation LED changes from green to red.

NOTE: All tests should be performed in the Continuous program on both channels.