C-me BodyGuard 595 Color Vision User manual

Ref: 100-099XCV
Edition Jan 2014
BodyGuard 595
Color Vision
TM
Pain Manager Infusion System
Operator Manual
0344
Manufacturer:
Caesarea Medical Electronics Ltd.
23 Staufenburg st.
72805 Lichtenstein, Germany
T: [phone]
E: [e-mail]
W: www.cme-infusion.com

BodyGuard 595™Color Vision Operator Manual
2

NOTE: to assure proper use of the BodyGuard 595 Color Vision™, Caesarea
Medical Electronics Ltd. urges all users to read this manual carefully, become
familiar with the procedures and system functions and follow all
recommendations.
U.S.A. federal law restricts this device to sale by or on the order of a
physician.

BodyGuard 595™Color Vision Operator Manual
3
Table of Contents
1 - Introduction 5
Overview 5
Keypad Descriptions and Functions 6
System Safety Checks 10
Pump Accuracy 11
2 –Symbols, Warnings and Cautions 15
System Symbols 15
Terms Used In Manual 16
Intended Use 16
Warnings 16
3 –Installation and Set Up 19
Unpacking 19
Charging the Pump 20
4 –Operation 22
Before Operating the Pump 22
Pump Operation Test 22
Air inLine –Alarm Test 23
Down Occlusion–Alarm Test 23
Door Open –Alarm Test 24
Battery Test 24
Charger Indicator Test 25
Operating the Pain Manager InfusionPump 25
Access Codes & Keypad Lock 26
Keypad Lock 26
Dedicated AdministrationSets 27
The BodyValve™ 28
MicroSet™ with 0.2mic Filter 29
Loading the AdministrationSet 29
Priming the Set 30
Modify Protocol 32
Select Protocol (start aninfusion) 43
Titrating Basal Rate During Infusion 47
Patient Activated Bolus 47
ClinicianActivated Bolus 48
Automatic Bolus Rate Adjustment 52
Interpreting the DisplayScreenDuring Infusion 52
MediGuardTM Option 53
Using History Functions 54
End of Program/Infusionand Bag Change 56
Eliminating Air During Operation 57
Down OcclusionAlarm 58
View Set Up 59
Change Set Up 59
Default Settings 60
5 –Alarm Conditions and Troubleshooting 62
Alarm Condition 62
Troubleshooting 63
6 –Specifications 65
7 –Service and Maintenance 67
Cleaning 67

BodyGuard 595™Color Vision Operator Manual
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Storage 67
Battery Operation 67
LIMITED WARRANTY 69

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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1 - Introduction
Overview
The BodyGuard 595 Color Vision™Pain Manager System provides the following
features:

Compact design, lightweight pump.

Infusion Programs:
Basal only
Basal & bolus
Bolus
Bolus can be one of the following:
Patient bolus
Auto bolus
Patient bolus combined with auto bolus
Program Modes:
PCA
Epidural
Regional

Highly accurate fluid delivery

Operated witha custom safe administrationset

Large multi-color display for enhanced visibility

Wi-Fi capability(802.11) –upload/download real time data from the pump
- manipulate pump from distance (optional)

Rechargeable internal lithium-ionbattery

Batterycharged ina pole mount charging cradle or with anA/C adaptor

Free flow protection valve standard on everyCME administration set

Quiet operation

Used for ambulatory care ina carrying pouch or mounted on an IV pole

2000 event log plus detailed patient history.

Ability to output history to PC (printer or file) using BodyCommTM software
(optional)

Utilize Wi-Fi technology (optional)

Prevents false occlusion alarms when delivering boluses through a EPIDURAL or
PCA catheter byautomatically varying bolus delivery rate.

Post-OcclusionBolus Prevention System

Uses color coding system (on the set and pump display) to enhance safety

MediGuardTM protectionensures protocol is appropriate to patients weight

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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Keypad Descriptions and Functions
Front of BodyGuard 595 Color Vision™Pain Manager
1. Operation LED
Green Indicator
Lights during system Self-Test
An intermittent green light indicates infusiondelivery
Red Indicator
Indicates an alarm state witha continuous red light
Lights when the pump is in a stand-by mode during
programming
2. Display Screen
Displays pump and infusionstatus
Displays programming choices and instructions
Deferent title bar color for each program (Blue- PCA,
Yellow- EPIDURAL, Green- REGIONAL)
3. 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.

Pause priming
Zeroes the displayed value during programming
Erases the last digit during programming
Returns to previous screen
4. Lock Operation
Will lock keys to prevent settings changes.
1
2
3
1
4
5
6
7
8
9
10

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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5. 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.
6. Numeric Keys
Enters numeric parameters during programming
7. STOP/NO
Stops infusion
Silences analarm condition
Pause priming
Zeroes the displayed value during programming
Erases the last digit during programming
Returns to previous screen
8. START/ OK
Starts infusion
Confirms selectionand setting
9. BOLUS
Change bolus parameters during operation (this function is
normally performed using the remote bolus cable). Can
be disabled under Change Set Up.
Activates clinician (CA) bolus when pump inSTOP mode.
10. Arrows
Scrolls up, down, right and left through options

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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BodyGuard 595 Color Vision™Pain Manager with Door Open
#
Area
Function
1.
Latch Holder
Holds the door closed when latchis in vertical
position.
2.
Flow Direction
Shows direction of pump operation.
3.
Pressure Sensor
Detects downstream tubing restrictionand
occlusion. Alarm level canbe adjusted to suit
patient needs.
4.
Keyway
Guides the administration line.
5.
Pressing Plate
Connected to the door by two springs.
6.
Pump Door
Covers the pressing plate.
7.
Anti-Stretch locator
Locates the tube in the correct length from the
key (Optional).
8.
Air sensor –Front
Ultrasonic air detector, whichis mounted onthe
front housing.
9.
Air sensor - Door
Mounted on the door.
9
7
8
1
2
3
4
5
6

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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BodyGuard 595 Color Vision™ Pain Manager Charger
#
Area
Function
1.
Charger Display
Displays major pump messages and operation
values.
2.
Release Handle
Push to release the pump from the Charger.
1
2

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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System Safety Checks
The following details outline the safety checks designed into the BodyGuard 595 Color
Vision™pump to minimize the possibility of under or over infusions.
Free Flow Protection
When the set is installed in the pump and the door close two ridges on the door clamp
the set so only the movement of the motor pistons can allow fluid to pass. With the door
open protection is afforded by a check valve, present in all BodyGuard 595 Color
Vision™sets, that prevents free flow towards the patient when the set is not attached to
the pump. When the pump is attached to the set and delivering fluid, the pressure
delivered by the pump opens the valve. The check valve also prevents reflux. The design
of the check valve means that although a pressure of 2-3psi can open the check valve in
the directionof the patient reflux cannot occur regardless of the pressure that builds up in
the set.
Post Occlusion Bolus Reduction System
During an occlusion, pressure in the downstream section of the line can build up to
1100mmHg (depending on user defined settings). When the pump alarms the user will
check the line and attempt to clear the occlusion. In the absence of Post Occlusion
Bolus Reduction System the pressure build up could cause a surge of fluid into the
patient. This feature works by reversing the operation of the motor until pressure in the
downstream line is returned to neutral (usually within 15 seconds).
Air-in-Line Detection
BodyGuard 595 Color Vision™utilizes two modalities to detect air-in-line. The ultrasonic
detector can be configured between 0.0 (OFF in epidural mode only) & 1.0ml on the
BodyGuard 595 Color Vision™pump for single bubble detection whilst a cumulative
check triggers the alarm if an accumulation of smaller bubbles totals 1.0ml (non-
configurable) in any 15 minute period. Although a single bubble may not exceed the user
defined threshold (e.g. 0.5ml) if the cumulative volume of smaller bubbles exceeds 1ml
(e.g. if three 0.4ml bubbles pass the sensor within a 15 minute period) an ‘Air or Up
Occlusion’ alarm is activated. This accumulation feature is particularly useful when
infusing products that create a significant number of small air bubbles (out-gas) to a
patient who is highly sensitive to air (i.e. infants, neonates, children).
Program Limits (including MediGuardTM toxicity settings)
Under ‘Change Set Up’ users can choose from a number of options to limit protocol
parameters and set safe ceilings on drugs infused. When the MediGuardTM feature is on
users are asked to set the patients weight (kg) and a toxicityceiling in ml, mg or mcg per
hour per kilogram bodyweight. If users try to set a protocol where the component
elements (basal rate and boluses) exceeds the MediGuardTM limit the pump will alert the
user to this and request they re-confirm their intentions, amend or revise the toxicity
ceiling. Level One user will not be able to change the protocol or ceiling under Select
Protocol and will have to select an alternative appropriate protocol or consult senior
clinical staff with Level 3 authorization. Under Program Limits you can choose to limit
the bolus volume over either a 1, 4,or 24 hour period according to local practice.

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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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/220C). Any
deviations from normal conditions and room temperature may cause changes in the
accuracy of the pump.
Start-up Curves
The Start-up curves represent continuous flow versus operating time for two hours from
the start of the infusion. They exhibit the delay in onset of delivery due to mechanical
compliance and provide a visual representation of uniformity. Trumpet curves are
derived from the second hour of this data. Tests performed according to IEC 60601-2-
24 standard.
Trumpet and Flow Rate
With the BodyGuard 595 Color Vision™, as with all infusion systems, the action of the
pumping mechanism and variations cause short term fluctuations in rate accuracy.
The following curves show typicalperformance of the system in two ways:
The accuracy of fluid delivery over various time periods is measured (trumpet curves).
The delay in onset of fluid flow when infusioncommences (start up curves).
Trumpet curves are named for their characteristic shape. They display discrete data
averaged over particular time periods or “Observation windows”, not continuous data
versus operating time. Over long observation windows, short-term fluctuation has little
effect on accuracy as represented by the flat part of the curve. As the observation
window is reduced, short-term fluctuations have greater effects as represented by the
“mouth” of the trumpet.
Knowledge of system accuracy over various observation windows may be of interest
when certain drugs are being administered. Short-term fluctuations in rate accuracy

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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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.

1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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1 –Introduction
BodyGuard 595™Color Vision Operator Manual
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Trumpet Graph at 25 ml/h (2nd hour of delivery)

2 –Symbols, Warnings and Cautions
BodyGuard 595™Color Vision Operator Manual
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2 –Symbols, Warnings and Cautions
System Symbols
The following symbols are used on the BodyGuard 595 Color Vision™Pain Manager
and components. Labels on the system or statements in this manual proceeded by any
of the following words and/or symbols are of special significance and are intended to
help youto operate the pump in a safe and successfulmanner.
Caution, consult accompanying Instructions
Attention,refer to operating instructions
0344
CE mark indicates conformance to Medical Device Directive
93/42/EEC
Do not dispose ofin 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 ofbatteryin municipal waste. Symbol indicates
separate collection for batteryis 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 withEthylene Oxide
LOT
STERILE EO

2 –Symbols, Warnings and Cautions
BodyGuard 595™Color Vision Operator Manual
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Terms Used In Manual
Warning:indicates that the information is a warning. Warnings advise you of
circumstances that could result in injury or deathto the patient or operator.
Read and understand this manual and all warnings completely before
operating the BodyGuard 595 Color Vision™PainManager.
Caution:indicates that the information is a caution. Cautions advise you of
circumstances that could result indamage to the device.
Read and understand this manual and all cautions completely before operating
the BodyGuard 595 Color Vision™PainManager.

NOTE: indicates that the information that follows is additional important
information or a tip that will help you operating the BodyGuard 595 Color
Vision™PainManager.
Intended Use
The BodyGuard 595 Color Vision™Pain Manager 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 and general fluids therapyin hospital and home care environments.
The BodyGuard 595 Color Vision™Pain Manager Infusion Pump is designed for
patients who require Epidural, Regional or PCA pain management. Please ask your
local representative or contact us direct for further details. Please ensure the pumps are
only used by, or under the supervisionof, trained medical staff.
Warnings
To avoid possible personal injury or loss of life, observe the following:
Using the pump with air in line detector off may cause an embolism resulting
death or paralysis. Switching the air detector off is not recommended and should
be used only when absolutely necessary. Please contact your technician in order
to enable the air sensor if disabled with no need.
Read the entire Operation Manual before using the pump, since the text includes
important precautions.
The maximum volume that may be infused under SINGLE FAULT CONDITION
is 0.1 ml
Voltage present on internal components may cause severe shock or death upon
contact. Disconnect the Charger from the mains, prior to opening the casing.
Only trained service personnel should open the pump cover.

2 –Symbols, Warnings and Cautions
BodyGuard 595™Color Vision Operator Manual
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Blown fuses could cause a fire hazard. Replace blown fuses on the Charger only
with fuses of the same type and rating (see fuse values on the Charger PCB).
Boluses will be infused up to the full volume that is requested unless the user
stops the bolus manually by pressing . This is true even when the volume
infused is less than the specified Hour Limit for Volume (e.g. 4 Hr Limit) at the
beginning of a bolus and goes over the limit during the bolus.
Make sure the pump is attached securely to the Charger, which is connected
snugly to an IV pole.
A kinked or occluded administration line may impair the operation of the pump
and the accuracy of the infusion. Before operation, verify that the administration
line is not kinked or occluded.
The BodyGuard 595 Color Vision™should be operated only with the MicroSetTM
administration lines. Use of administration lines other than the MicroSetTM may
impair the operation of the pump and the accuracyofaninfusion.
Drugs must not be administered to the Epidural space unless the drugs are
indicated for this purpose and are administered in accordance with the
indications included in the manufacture’s package. Epidural administration of
drugs other than those indicated for Epidural use could result in serious injury to
the patient. For Epidural administration of drugs use MicroSetTM only.
Any adjustments, maintenance, or repair of the uncovered pump may impair the
operation of the BodyGuard 595 Color Vision™Pain Manager and/or the
accuracy of the infusion. Any adjustments, maintenance, or repair of the
uncovered pump or charger should be performed by authorized skilled
technicians. Any adjustments, maintenance, or repair of the uncovered pump or
charger while connected to the power should be avoided.
The BodyGuard 595 Color Vision™Pain Manager should be operated within a
temperature range of 10C (50F) to 45C (113F) and up to 85% humidity.
Operating the pump at temperatures and/or humidity other than within that range
may affect accuracy.
Unsafe operation may result from using improper accessories. Use only
accessories and options designed for this system.
Disposables must be compatible with the medicine delivered.
Battery charging is enabled as long as the charger cord is connected to the
mains and the pump is in the charger. Switching the pump off does not
disconnect it from the mains. To disconnect from mains, remove the charger
cord from mains. To disconnect pump from mains, remove it from the charger.
Dropping the BodyGuard 595 Color Vision™Pain Manager could cause damage
to components. If the pump is dropped, return the pump for inspection by
qualified service personnel.
Use aseptic technique. Patient infection may result from the use of non-sterile
components. Maintain sterility of all disposable components and do not re-use
single use administration sets.

2 –Symbols, Warnings and Cautions
BodyGuard 595™Color Vision Operator Manual
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Watch your fingers and nails whenopening the pump door.
When operating the pump on PCA program with a rate of 0.0 ml/h there is a
hazard of blood clot forming. Connect saline infusion in parallel to avoid this
problem.
When operating the pump on PCA program, the program will not enter KVO,
even if the limit volume is acceded. The program will complete the bolus and
than enter KVO.
In a clinical setting, bolus cables can be damaged by crushing (under foot or in
the bed frames) or cutting (trapped in the bed-frame or cut by scissors when
removing dressings, etc.)

3 –Installation and Set Up
BodyGuard 595™Color Vision Operator Manual
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3 –Installation and Set Up
Unpacking
1.
Carefully remove the pump and Charger from the box.
2.
Make sure no items were damaged during shipment
3.
Make sure you have the following items:

BodyGuard 595 Color Vision™Infusion Pump

Charging Cradle with Power Cord or Battery Charging Cable

Rechargeable Battery Pack

Operation Manual

Bolus cable

9V Alkaline Battery compartment (optional)

Disposable Battery Pack (optional)

External charger (optional)

Extended life batteryLi-Ion Polymer
If any items are missing or damaged, contact your BodyGuard 595 Color Vision™
supplier.

3 –Installation and Set Up
BodyGuard 595™Color Vision Operator Manual
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Charging the Pump

NOTE: the pump is protected against overcharging. In order to keep your
battery fully charged, connect the pump to the mains via the Charger whenever
possible. Be sure that the batteryis fullycharged at all times.
Warning: if the battery is removed during operation while pump is not
connected to a charger connected to mains, the pump will turn off.
1.
Connect the charger unit to AC power and verify that the AC indicator is lit.
2.
Put the pump into the charger (top first) until it clicks into place.
3.
The battery is charging when the red battery LED on the front of the charger is
lit. The battery is fully charged when the battery LED symbol turns green. If the
led does not light or does not turn green after more than 6 hours, pls. replace
battery.
4.
Remove the pump from the charger by pressing the release button (located next
to the LED indicators on the charger), Lift the pump out of the charger bottom
first.