C-me Color Vision BodyGuard 595 Manual

Ref.: DFU999-803EN Rev.01
BodyGuard 595
Color Vision
TM
Pain Manager Infusion System
Directions For Use
MedNet GmbH.
Borkstrasse 10
48163 Muenster
Germany
T: [phone]
Caesarea Medical Electronics Ltd.
16 Shacham Street
Industrial Park Caesarea North
P.O.Box 3009
Caesarea 3088900, Israel
E: [e-mail]
W: www.cme-infusion.com
0344

BodyGuard 595 Color Vision™Directions For Use
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BodyGuard 595 Color Vision™Directions For Use
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 14
System Symbols 14
Terms Used In Manual 16
Intended Use 16
Warnings 16
Cautions 18
3 – Installation and Set Up 19
Unpacking 19
Charging the Pump 19
4 – Operation 21
Operating the Pain Manager Infusion Pump 21
Access Codes and Keypad Lock 21
Keypad Lock 21
Dedicated Administration Sets 22
The BodyValve™ 23
MicroSet™ with 0.2mic Filter 24
Loading the Administration Set 24
Priming the Set 25
Modify Protocol 27
Select Protocol (start an infusion) 38
Titrating Basal Rate During Infusion 41
Patient Activated Bolus 42
Auto Bolus 43
Bolus Menu 43
Clinician Activated Bolus 44
Automatic Bolus Rate Adjustment 46
Interpreting the Display Screen During Infusion 47
MediGuardTM Option 48
Using History Functions 49
End of Program/Infusion and Bag Change 50
Eliminating Air During Operation 52
Down Occlusion Alarm 53
View Set Up 53
Change Set Up 53
Pump Parameters 55
5 – Alarm Conditions and Troubleshooting 57
Alarm Condition 57
Alarm Definitions 58
Definition of Alarm Types 58
Sound Pressure Level (SPL) for Alarm Signals 58
Troubleshooting 59
6 – Specifications 63
7 – Service and Maintenance 69
Cleaning 69
Storage 69
Periodic Maintenance 69
Battery Replacement 70
Battery Operation 70
LIMITED WARRANTY 72

BodyGuard 595 Color Vision™Directions For Use
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1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
5
1 - Introduction
Overview
The BodyGuard 595 Color Vision™ Pain Manager System provides the following features:

Compact design, lightweight pump.

Ambulatory pump

Multiple Delivery Methods:
Basal only
Basal & bolus
Bolus only
Multiple Bolus Types:
Patient bolus
Auto bolus
Patient bolus combined with auto bolus
Infusion Modes:
PCA
Epidural
Regional

Accurate fluid delivery

Operated with a custom safe administration set

Large multi-color display for enhanced visibility

Rechargeable internal Lithium-Polymer battery

Battery charged in a BodyGuard Color Vision Charger or with an A/C adapter

Free flow protection Anti-Siphon valve standard on every CME administration set

Quiet operation

2000 event log plus detailed patient history

Prevents false occlusion alarms when delivering boluses through an EPIDURAL
or PCA catheter by automatically varying bolus delivery rate

Post-Occlusion Bolus Reduction System

Uses color coding system on the set and pump display

MediGuardTM protection ensures drug protocols are suitable with patient weight

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
6
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 infusion delivery
Red Indicator
Indicates a High Priority alarm state with a continuous red
light
Yellow Indicator
Indicates a Medium Priority alarm state with a flashing
yellow light
Indicates a Low Priority alarm state with a solid yellow
alarm state
1
1
2
3
4
5
6
7
8
9
10

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
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
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
prevent accidental or deliberate change to pump operation.
Pause priming
Zeroes the displayed value during programming
Erases the last digit during programming
Returns to previous screen
2. Display Screen
•Displays pump operations and infusion status
•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.
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/BACK/CANCEL
•Stops infusion
•Mutes the alarm 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 selection and 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 in STOP mode.
10. Arrows
•Scrolls up, down, right and left through options

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
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BodyGuard 595 Color Vision™Pain Manager with Door Open
#
Area
Function
1.
Latch Holder
Holds the door closed when latch is in vertical
position.
2.
Flow Direction Arrows
Shows direction of pump operation indicating the
flow to the patient.
3.
Pressure Sensor
Detects downstream tubing restriction, occlusion,
and set key. Downstream occlusion alarm level
can be adjusted to suit the patient needs.
4.
Set Key
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
(Optional)
Locates the tube in the correct length from the set
key
8.
Air sensor – Front
Ultrasonic air detector, which is mounted on the
door.
9.
Air sensor –Door
Mounted on the door.
9
7
8
1
2
3
4
5
6

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
9
BodyGuard 595 Color Vision™ Charger
33

NOTE: 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.
The plug is the main isolation device for the pump. Do not position the pump in such a
way to make it difficult to disconnect from the mains.
#
Area
Function
1.
Charger Display
Displays major pump messages and operation
values.
2.
Release Handle
Push to release the pump from the Charger.
3.
Charger LED (orange)
Indicates connection to supply mains.
4.
Pump Battery LED (red/green)
Indicates battery charge status.
1
2
3
4

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
10
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
The system’s customized IV lines are equipped with a check valve that prevents
free flow towards the patient when the IV line is not attached to the pump. When
the pump is attached to the IV line and delivering fluid, the pressure delivered by
the pump opens the valve. The valve is also one way valve preventing fluids flow
from the patient to the administration line
Post Occlusion Bolus Reduction System (POBRS)
The POBRS 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.
Unintended Bolus
Intermediate Rate
Occlusion Pressure
Unintended Bolus Volume
25ml/h
250mmHg (minimum)
1500mmHg (maximum)
≤0.5ml
An occlusion may pressurize the infusion tubing, which can result in an unintended
bolus of drug when the occlusion is cleared. In order to prevent this additional
bolus, disconnect the tubing or relieve the excess pressure through a stopcock, if
present. The clinician should weigh the relative risks of disconnection with the risks
of an unintended bolus of drug.
Air-in-Line Detection
BodyGuard 595 Color Vision™ uses two modalities to detect air-in-line. The ultrasonic
detector can be configured between 0.04 ml -1.0 ml on the BodyGuard 595 Color Vision™
pump for single bubble detection while 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 toxicity ceiling 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

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
11
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.
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 (72° F or 22° C ).
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.

1 – Introduction
BodyGuard 595 Color Vision™Directions For Use
12
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 typical performance 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 infusion starts (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 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™Directions For Use
13
Trumpet Graph at 25 ml/h (2nd hour of delivery)

2 – Symbols, Warnings, and Cautions
BodyGuard 595 Color Vision™Directions For Use
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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 you
to operate the pump in a safe and successful manner.
Caution
Warning
Refer to DFU.
Read the entire DFU before using the pump.
Appears on the display after operator presses to mute the alam
condition. Pump is not infusing.
0344
CE mark indicates conformance to Medical Device Directive
93/42/EEC
Do not dispose of in municipal waste. Symbol indicates separate
collection for electrical and electronic equipment. (WEEE Directive
2002/96/EEC). NOTE: does not apply to the battery.
Do not dispose of battery in municipal waste. Symbol indicates
separate collection for battery is required
The use of single-use disposable components on more than one
patient is a biological hazard. Do not reuse single-use disposable
components.
Type CF applied part
Date of Manufacture
Serial Number
Direct current
Expiry Date of disposable
Alternating current
Lot Number
LOT

2 – Symbols, Warnings, and Cautions
BodyGuard 595 Color Vision™Directions For Use
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Battery
Sterilized with Ethylene Oxide (applicable to administration sets)
IP33
Degree of particle and water ingress protection.
Defintion of code:
I=Ingress
P=Protection
3= Protection from solid objects ≥ 2.5 mm
3=Protection from spraying water
Class II Medical Electrical Equipment providing double insulation for
operator and patient safety
Identifies the manufacturer of a product.
Indicates the authorized representative in the European Community.
Indicates the acceptable upper and lower limits of atmospheric
pressure.
Indicates the acceptable upper and lower limits of relative humidity.
Indicates the temperature limits to which the medical device can be
safely exposed.
Indicates the manufacturer’s catalogue number so that the medical
device can be identified.
Indicates a medical device that should not be used if the package has
been damaged or open.
Indicates the number of drops per milliliter.
STERILE EO

2 – Symbols, Warnings, and Cautions
BodyGuard 595 Color Vision™Directions For Use
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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 death to the patient or operator.
Read and understand this manual and all warnings completely before operating
the BodyGuard 595 Color Vision™ Pain Manager.
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 595 Color Vision™ Pain Manager.

NOTE: indicates that the information that follows is additional important
information or a tip that will help you operating the BodyGuard 595 Color
Vision™ Pain Manager.
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, intrathecal, 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 in 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. The BodyGuard 595 Color
Vision™ Infusion System is for use by, or under the supervision of trained medical staff
in the hospital and the home care environments. *DOUBLE CHECK*
Warnings
To avoid possible personal injury or loss of life, observe the following:
Read the entire DFU 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.
Make sure the pump is attached securely to the Charger, which is connected
firmly 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 accuracy of an infusion.

2 – Symbols, Warnings, and Cautions
BodyGuard 595 Color Vision™Directions For Use
17
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 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 the
recommended environment operating range.. 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.
The plug is the main isolation device for the pump.
No modification to this equipment is allowed.
Do not use this equipment with other infusion systems or accessories that are not
approved to be used with this pump system.
Pump should be stored with the battery connected, otherwise the internal
rechargeable battery may lose track of actual time.
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.
Do not operate the pump near high-energy radio-frequency emitting equipment,
such as electro-surgical cauterizing equipment, or within 1800 ft of a transmitting
television broadcast antenna. False alarm signals may occur.
Do not let the pump operate when battery is fully depleted. Pump may turn off
during operation on fully depleted battery. Before beginning infusion, ensure that
the pump battery is fully charged.
Prior to first use, technical service personnel shall verify functionality of pump per
the Technical Service Manual.
Do not use the BodyGuard Infusion Pump in close proximity to high energy
medical equipment (e.g., Imaging equipment (i.e., X-Ray, MRI, CT Scan, etc.),
High Frequency (RF) Surgical Equipment, Defibrillator, etc.) as this may cause
degradation in performance of the Infusion Pump, which may affect proper
infusate delivery.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally.

2 – Symbols, Warnings, and Cautions
BodyGuard 595 Color Vision™Directions For Use
18
Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the BodyGuard Infusion Pump, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could
result.
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.
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.)
Lithium Metal Batteries – Forbidden for transport aboard passenger aircraft.
Infusion of blood or blood products should be restricted to a maximum rate of 600
ml/h.
Cautions
To avoid possible damage to the equipment, observe the following:
Leaving the battery in a depleted 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 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 with hydrogen peroxide 10% or isopropyl alcohol 70%.
Immersing the BodyGuard 595 Color Vision™ infusion pump into liquid could cause damage to
components. Do not immerse the pump into any type of liquid.
The BodyGuard 595 Color Vision™ infusion pump is not certified for use in oxygen-enriched
environments.
Battery damage could occur if left in a temperature warmer than 500C (122F).
Potential strangulation may occur if the cables/tubing are of excessive length.
Potential choking may occur if small parts are inhaled or swallowed.
Potential allergic reactions may occur due to materials used in the pump.
The front panel push buttons may become hot to the touch when the pump is operated in an
elevated temperature environment up to 45 °C (i.e., outdoors or in a hot automobile).

3 – Installation and Set Up
BodyGuard 595 Color Vision™Directions For Use
19
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 (cable length: 2.5
meters)

Rechargeable Battery Pack Li Polymer

Directions for Use (DFU)

Applicable Quick Reference Guide(s)

PCA Bolus cable (optional) (Cable length: 2.0 meters)

Tabletop charger (optional)

External wall charger (optional) (cable length:
2.0 meters)
NOTE: If any items are missing or damaged, contact your BodyGuard 595
Color Vision™ supplier.
NOTE: In certain locales, Power Cord may come as a separate item.
Charging the Pump

NOTE: the pump is protected against overcharging. In order to keep your battery
fully charged, connect the pump to the mains via the Charger whenever possible.
Be sure that the battery is fully charged at all times.
Warning: if the battery is removed during operation while pump is not connected
to a charger connected to mains, the pump will turn off.

3 – Installation and Set Up
BodyGuard 595 Color Vision™Directions For Use
20
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 8 hours, 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.
Release Button
Caution: leaving the battery discharged for a long period of time may damage
the battery.