C-me BodyGuard 575 Color Vision User manual

Software ver. CVPCA30E_1 1
BodyGuard® 575
Color Vision
PCA Infusion System
Operator Manual
0344
Manufacturer:
Caesarea Medical Electronics GmbH.
23 Staufenburg st.
72805 Lichtenstein, Germany
International Toll Free: [phone]
www.cme-infusion.com
Contact e-mail: [e-mail]
EDITION February 2013
Ref.: 100-095XCV

Software ver. CVPCA30E_1 2
Contents
1- Introduction 4
Overview 4
Keypad Descriptions and Functions 5
The Charger 8
System Safety Checks 9
2 –Symbols, Warnings and Cautions 10
System Symbols 10
Terms Used In Manual 11
Intended Use 11
Warnings 11
3 –Installation and Set up 14
Unpacking 14
Charging the Pump 15
4 –Operation 16
Before Operating the Pump 16
Pump Operation Test 16
Air in Line –Alarm Test 17
Down Occlusion –Alarm Test 17
Door Open –Alarm Test 18
Battery Test 18
Charger Indicator Test 19
Operating the BodyGuard® PCA Pump 20
Access Codes & Keypad Lock 20
Dedicated BodyGuard® Administration Sets 22

Software ver. CVPCA30E_1 3
Loading the Administration Set 24
Priming the Set 25
Modify Protocol 26
Select Protocol (start an infusion) 33
Titrating Basal Rate During The Infusion 35
Patient Activated Bolus 35
Clinician Activated Bolus 36
Interpreting the Display Screen During Infusion 39
MediGuard® Option 40
Using History Functions 42
End of Program/Infusion and Bag Change 44
Eliminating Air During Operation 45
Down Occlusion Alarm 45
Review Set Up 46
Change Set Up 46
BodyGuard® Default Settings 47
5 –Alarm Conditions and Troubleshooting 48
6 –Specifications 51
7 –Service and Maintenance 53
Cleaning 53
Storage 53
Battery Operation 53
Pump Accuracy 55
LIMITED WARRANTY 58

Software ver. CVPCA30E_1 4
1- Introduction
Overview
The BodyGuard® Color Vision PCA System provides the following features:

Small, light and compact pump.

Multiple Programs:
□Bolus only (Patient Controlled) - 0.1-25.5ml @ 100-1000ml/h
□Continuous (basal) plus patient controlled bolus (PCEA)
□Continuous only (PCA Analgesia(EA)- infuse 0.1-1000ml @ 0.1-100ml/hr

Highly accurate fluid delivery

Operated with a custom safe administration set

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-ion battery

Battery charged in a pole mount charging cradle or with an A/C adaptor

Free flow protection valve standard on every CME administration set

Quiet operation

Used for ambulatory care in a carrying pouch
or mounted on an IV pole
Button Descriptions and Functions
512 event log plus detailed patient history (1024 events log is optional).
Ability to output history to PC (printer or file) using BodyComm® software (optional)
oUtilize Wi-Fi technology (optional)
Prevents false occlusion alarms when delivering boluses through a PCA catheter by
automatically varying bolus delivery rate.
Post-Occlusion Bolus Prevention System
Uses color coding system to enhance safety
MediGuard® protection ensures protocol is appropriate to patients weight

Software ver. CVPCA30E_1 5
Keypad Descriptions and Functions
Front of BodyGuard® PCA infusion pump:
1. Display Screen
Displays pump and infusion status
Displays programming choices and 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
Pause priming
Zeroes the displayed value during programming
Erases the last digit during programming
Returns to previous screen
1
2
3
4
5
7
6
9
8
10

Software ver. CVPCA30E_1 6
5. BOLUS
Administers bolus dose during PCA regimes (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.
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. Operation LED
Green Indicator
Lights during system Self-Test
An intermittent green light indicates infusion delivery
Red Indicator
Indicates an alarm state with a continuous red light
Lights when the pump is in a stand-by mode during
programming
8. 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.
9. Down Arrow
Scrolls down through options
10. Numeric Keys
Enters numeric parameters during programming

Software ver. CVPCA30E_1 7
BodyGuard® Infusion Pump 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
Guides the ADMINISTRATION 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.
9.
Anti-Stretch locator
Locates the tube in the correct length from the
key (Optional).
1
8
2
3
4
5
7
8
9

Software ver. CVPCA30E_1 8
The Charger
1
2
#
Area
Function
1.
Charger Display
Displays major pump messages and operation
values.
2.
Release Handle
Push to release the pump from the Charger.
2
1

Software ver. CVPCA30E_1 9
System Safety Checks
The following details outline the safety checks designed into the BodyGuard®
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® 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 direction of 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 10psi (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® utilizes two modalities to detect air-in-line. The ultrasonic detector
can be configured between 0.0 (OFF) & 1.0ml on the BodyGuard® 575 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/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 MediGuard® 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
MediGuard® feature is on users are asked to set the patients weight (kg) and a
toxicity ceiling in ml, mg or mcg per hour per kilo bodyweight. If users try to set
a protocol where the component elements (basal rate and boluses) exceeds the
MediGuard® limit the pump will alert the user to this and request they re-
confirm their intentions, amend or revise the toxicity ceiling. Level One users
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 authority. Alternatively you can choose to simply limit either the
rate or number of boluses delivered over either a 1, 4, or 24 hour period
according to local practice.

Software ver. CVPCA30E_1 10
2 –Symbols, Warnings and Cautions
System Symbols
The following symbols are used on the BodyGuard® Infusion System 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.
Attention, consult accompanying Instructions
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
Expiry Date of disposable
Lot Number
Sterilized with Ethylene Oxide
LOT
STERILE EO

Software ver. CVPCA30E_1 11
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® Infusion System.
Caution: Indicates that the information is a caution. Cautions advise you of
circumstances that could result in damage to the device.
Read and understand this manual and all cautions completely before operating
the BodyGuard® Infusion System.

NOTE: Indicates that the information that follows is additional important
information or a tip that will help you operating the BodyGuard® Infusion
System.
Intended Use
The BodyGuard® infusion 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, PCA, 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
therapy in hospital and home care environments.
The BodyGuard® 575 PCA Infusion Pump is designed for patients who require PCA
pain management. We recommend dedicated pumps for differentiation PCA
administration to prevent medication errors. The BodyGuard® is available in a color-
coded PCA format. Please ask your local representative or contact us direct for further
details. Please ensure the pumps are only used by, or under the supervision of, 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

Software ver. CVPCA30E_1 12
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.
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® should be operated only with the BodySet®/MicroSet®
administration lines. Use of administration lines other than the
BodySet®/MicroSet® may impair the operation of the pump and the accuracy of
an 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® Infusion System 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® Infusion System should be operated within a temperature
range of 18C (59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® Infusion System could cause damage to components.
If the pump is dropped, return the pump for inspection by qualified service
personnel.

Software ver. CVPCA30E_1 13
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.
Watch your fingers and nails when opening 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.)

Software ver. CVPCA30E_1 14
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® Infusion Pump

Charging Cradle with Power Cord or Battery Charging Cable

Rechargeable Battery Pack

Operation Manual

Disposable Battery Pack (optional)

PCA bolus cable

9V Alkaline Battery compartment (optional)

External charger (optional)

Extended life battery Li-Ion Polymer
If any items are missing or damaged, contact your BodyGuard® supplier.

Software ver. CVPCA30E_1 15
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.
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.
Caution: Leaving the battery discharged for a long period of time may damage
the battery.

Software ver. CVPCA30E_1 16
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.
When an alarm is activated the following occurs:

An alarm message appears on the display

An audible alarm sounds

Infusion ceases

The LED changes from green to red

NOTE: All tests should be performed in the Continuous program.
Pump Operation Test
1.
Click the pump into a Charger connected to AC power. Verify that
the CHARGE indicator is on, red or green light (on charger).
2.
Insert a BodySet® administration set and close the 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”.
3.
Press until the Self-Test screen appears. If air sensor is off, press
to confirm.
4.
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 self test is
completed, the display will show the last rate setting.
5.
Prime the set according to the priming instructions
following later in this manual.
6.
When priming is completed, wait 2 minutes
without pressing any key. After two minutes the
screen displays “Pump Paused Too Long” and an
alarm will sound. Press to silence the alarm
again or to exit alarm condition.

Software ver. CVPCA30E_1 17
Air in Line –Alarm Test
1.
Insert a BodySet® administration set and close the 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.
3.
Insert air into the ADMINISTRATION line to allow an air bubble greater than 10
mm to enter into the administration set.
Start infusion as instructed in the "Select protocol" section.
4.
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.
Down Occlusion –Alarm Test
1.
Insert a BodySet® into the pump and close the door. Press the door until a click
is heard.
2.
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”.
3.
Start infusion as instructed in the "Select protocol" section.
4.
Wait 5 minutes and than 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)
5.
Wait another 5 minutes and occlude the ADMINISTRATION line downstream of
the pump (between the pump and the pressure gauge).
6.
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
1 ml/hr up to 80 minutes
0.1 ml/hr up to 11 hours

NOTE: The pressure threshold can be changed to suit patient need (refer to
section on changing the current default Pressure Limit).
7.
8.
Depending upon the set flow rate and pressure
threshold, the Down Occlusion alarm will be
activated.
Press to mute the alarm.

Software ver. CVPCA30E_1 18
Door Open –Alarm Test
1.
Insert a BodySet® in the pump and close the 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. If air sensor is off, press
to confirm. Please contact your technician in order to enable the air sensor if
disabled with no need.
3.
Start infusion as instructed in the "Select protocol" section.
4.
Open the pump door.
5.
Door Open alarm will be activated at once.
6.
Close the door and press .
Battery Test
1.
Insert a BodySet® in the pump and close the 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.
Take the pump out of the charger.
3.
Press until the Self-Test screen appears. If air sensor is off, press
to confirm. Please contact your technician in order to enable the air sensor if
disabled with no need.
4.
Start infusion as instructed in the "Select protocol" section.

Software ver. CVPCA30E_1 19
5.
Wait untill pump displays “low battery” message
6.
Press to turn the pump off.
7.
Connect the pump to a charger.
8.
Verify the red icon of battery is lit (on the charger).
9.
Verify the red battery turns green after a minimum of 2 hours.
WARNING: Do not let the pump operate when battery is fully discharged. Pump
may turn off during operation on fully discharged battery without
alarm.
Charger Indicator Test
1.
Click the pump into the charger and connect the Charger to mains. Disconnect
the power cord from the AC power outlet.
2.
Verify that the CHARGE indicator is OFF.
3.
Connect the power cord to the AC power outlet. Verify that the CHARGE
indicator is ON.

Software ver. CVPCA30E_1 20
Operating the BodyGuard® PCA Pump
NOTE: Before using the BodyGuard® for the first time please ensure you have
carried out the 'pump operation tests’ as detailed in the previous
chapter. These tests should be carried out periodically to ensure all
systems are functioning correctly.
Before performing any of the set-up & period tests or to operate, program or
configure the pump you will need to access the pump using the security codes. As
the BodyGuard® 575 is designed for pain management therapies the pump has
several levels of security to ensure safe set up and administration of pain protocols
and to prevent idle or malicious tampering.
Access Codes & Keypad Lock
To operate, program and configure the BodyGuard® PCA Infusion pump three
Access Codes are required.
All codes and codes levels can be modified and controlled from technician menu.
Level One 700 Allows user to run pre-set protocols and titrate
infusion rate (within pre-set protocol limits).
Level Two * Allows authorized users to deliver Clinician Activated
Bolus or loading dose.
Level Three ** Allows users to set up or modify standard infusion
protocols & change pump configuration parameters in
‘Change Set Up’.
* / ** refer to senior clinical or lead service personnel.
Additionally, a technician’s code is necessary to access the technician menu but
this is only provided to fully trained & authorized electrical biomedical engineering
departments.