CME Medical BODY GUARD 545 User manual

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
1
Operaon Manual
CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual Rev 2.3 October 2013

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
2
NO DESCRIPTION PAGE
1.0 BODYGUARD PUMP OVERVIEW 3
2.0 PUMP DESCRIPTION AND FUNCTIONS 4-6
3.0 SYSTEM SAFETY CHECKS 7
4.0 SYMBOLS AND LABELS 8
5.0 INTENDED USE, WARNINGS, NOTES AND PRECAUTIONS 9-10
6.0 INSTALLATION AND SET-UP (Including Baery Charging and Powering Up) 11-12
7.0 OPERATING THE BODYGUARD PUMP 13-32
7.1 Security: Access Codes and Keypad Lock 13
7.2 Seng Up and Modifying Protocols 14-17
7.3 Administraon Sets 18
7.4 Loading the Administraon Set 19
7.5 Powering Up and Priming a Set 20
7.6 Selecng a Protocol 21
7.7 Interpreng Display Screen Whilst Infusing 22
7.8 Rate Change During Delivery (Rate Titraon) 22
7.9 Bolus Dose Delivery: Paent Controlled/Clinician Acvated 23-25
7.10 End of Infusion and Bag Change 26
7.11 Using History Funcons: Current Paent and 512 Event log 27-28
7.12 Eliminang Air During Operaon 29
7.13 Alarms, Alerts and Troubleshoong 30-31
7.14 Review Pump Set Up 32
7.15 Change Pump Set Up 32
7.16 Keep Vein Open (KVO) 32
7.17 MAINTENANCE AND SERVICE 33
8.0 APPENDICES 34-44
10.0 INDEX 45
CONTENTS

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
3
1.0 BODYGUARD PUMP OVERVIEW
The BodyGuard™ 545 Epidural Infusion Pump provides the following
 Mulple programmes
- Bolus only (Paent Controlled (PCEA))
- Connuous (basal) plus paent controlled bolus
- Connuous only epidural analgesia
 Used for ambulatory care, can be pole mounted or used with a carrying pouch
 A small, light and compact pump with quiet operaon
 +/- 5% accuracy, even at low infusion rates
 Rechargeable Li-Polymer internal baery and mains operaons
 Baery charged in a pole mount charging cradle or with an A/C adaptor
 Free-ow protecon integral to all administraon sets (an-siphon/reux)
 Prevents false occlusion alarms when delivering boluses through an epidural catheter by automacally
varying bolus delivery rate
 Post-occlusion bolus prevenon system
 MediGuard™ protecon ensures protocol is appropriate to paents weight
 512 Event Log plus detailed paent history (1024 events log is oponal)
 Ability to output history to PC (printer or le) using BodyComm™ communicaon soware (oponal)

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
4
1. DISPLAY SCREEN
a. Displays pump/infusion status
b. Displays programming choices and instrucons
2. UP ARROW
a. Scrolls up through opons on menu screens
3. START/OK
a. Conrms parameter selecon
b. Starts infusion
4. STOP/NO
a. Stops infusion/bolus
b. Silences an alarm condion
c. Stops priming
d. Zeroes the displayed value during programming
e. Erases the last digit during programming
f. Returns to previous screen
g. Returns to main menu when held down for 2 seconds aer stopping
infusion delivery
5. BOLUS
a. Administers bolus dose during PCA regimes (this funcon is normally
performed using the remote bolus cable)
b. Acvates clinician (CA) bolus when pump in STOP mode. (Can only be
acvated under code condions)
2.0 PUMP DESCRIPTION AND FUNCTIONS
FRONT OF BODYGUARD PUMP
10

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
5
6. POWER ON/OFF
a. Turns the pump on by pressing and holding the key unl the soware
version conrmaon screen appears and a beep is heard
b. Turns the system o by pressing and holding the key unl the graph is
black and a beep is generated
7. LED window (beneath the bolus and on/o keys)
a. Green Indicator
- Lights during system self-test
- Intermient green light indicates infusion delivery
b. Red Indicator
- Indicates an alarm state with a connuous red light
- Lights when the pump is in a stand-by mode during programming
8. INFO
a. When pressed during infusion displays:
- Infused volume and total to be infused
- Baery status
- Bolus aempts, given and Clinician Bolus volume
- Protocol review screen
- Date and me
b. Press and then to access:
- Volume and boluses given in the last 24 hours
- Hour-by-hour ulisaon data
- Hour-by-hour chart of bolus demand in last 24 hours
- Hour-by-hour chart of volume infused in last 24 hours
c. Holding the key down whilst the pump is infusing (unl the graph
displayed turns black), locks and unlocks the keypad to prevent
accidental or deliberate changes to pump operaon
9. DOWN ARROW
a. Scrolls down through opons on menu screens
10. NUMERICAL KEYS
a. Enters numeric parameters during programming
b. Enter access code

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
6
BODYGUARD PUMP WITH DOOR OPEN
No. Area Funcon
1 Door latch Opens the door and holds it closed when latch is in
vercal posion
2Pressure sensor Detects downstream tubing restricon and occlusion
(behind keyway) alarm level adjustable to suit paent/infusion type
3Keyway Guides the administraon set into correct posion and
ensures only dedicated administraon sets are used
4Pressing plate Connected to the door by two springs
5Pump door Covers the pressing plate
6Air sensor - front Ultrasonic air detector mounted on the front housing
7Air sensor- door Mounted on the door
8Flow direcon Shows direcon of uid ow
BODYGUARD PUMP IN CHARGING UNIT
Charger display
Displays major pump messages and operaon values
Release handle
Push to release the pump from the charging unit
1
2
3
4
5
8
6
7

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
7
3.0 SYSTEM SAFETY CHECKS
The following details outline the safety checks designed into the BodyGuard™ pump to minimise the
possibility of under or over infusions.
FREE FLOW PROTECTION
When the set is installed in the pump and the door closed, two ridges on the door clamp the set so only
the movement of the motor pistons can allow uid to pass. With the door open, protecon is aorded by
a check valve, present in all BodyGuard™ sets, that prevents free ow towards the paent when the set is
not aached to the pump. When the pump is aached to the set and delivering uid, the pressure
delivered by the pump opens the valve. The check valve also prevents reux. The design of the check
valve means that although a pressure of 2-3psi can open the check valve in the direcon of the paent,
reux cannot occur regardless of the pressure that builds up in the set.
POST OCCLUSION BOLUS REDUCTION SYSTEM
During an occlusion, pressure in the downstream secon of the line can build up to 21psi (depending on
user dened sengs). When the pump alarms the user will check the line and aempt to clear the
occlusion. In the absence of Post Occlusion Bolus Reducon System the pressure build up could cause a
surge of uid into the paent. This feature works by reversing the operaon of the motor unl pressure
in the downstream line is returned to neutral (usually within 15 seconds).
AIR-IN-LINE DETECTION
The BodyGuard™ pump ulises two modalies to detect air-in-line. The ultrasonic detector can be cong-
ured between 0.0 (OFF) and 1.0ml on the BodyGuard™ pump for single bubble detecon whilst a
cumulave check triggers the alarm if an accumulaon of smaller bubbles totals 1.0ml (non-congurable)
in any 15 minute period. Although a single bubble may not exceed the user dened threshold (e.g. 0.5ml)
if the cumulave 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 acvated. This accumulaon feature is
parcularly useful when infusing products that create a signicant number of small air bubbles (out-gas)
to a paent who is highly sensive to air i.e. infants, neonates, children. If OFF (0.0ml) there is a 3ml
volume for air in line detecon.
PROGRAMME LIMITS (including MediGuard™ toxicity sengs)
Under ‘Change Set Up’ users can choose from a number of opons to limit protocol parameters and set
safe ceilings on drugs infused. When the MediGuard™ feature is on users are asked to set the paents
weight (kg) and a toxicity ceiling in either ml, mg or mcg (depending on pump conguraon) per kilogram
bodyweight per hour. 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-conrm
their intenons, 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 alternave appropriate protocol or
consult senior clinical sta with Level Three authority. Alternavely you can choose to simply limit either
the rate or number of boluses delivered over either a 0, 1, 4, or 24 hour period according to local
pracce.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
8
4.0 SYMBOLS AND LABELS
The following symbols are used on the BodyGuard pump, accessories and consumables. Labels on the
pump or statements in this manual preceded by any of the following words and/or symbols are of special
signicance, intended to help you to operate the pump in a safe and successful manner.
IPX3 Symbol for degree of protecon against ingress of water
Symbol for type of protecon against electric shock - Class II equipment
Aenon, consult accompanying instrucons
0344
CE mark indicates conformance to Medical Device Direcve 93/42/EEC
Do not dispose of in municipal waste. Symbol indicates separate collecon
for electrical and electronic equipment. (WEEE Direcve 2002/96/EEC)
NOTE: Does not apply to the baery
Do not dispose of baery in municipal waste. Symbol indicates separate
collecon for baery is required
The use of single-use disposable components on more than one paent 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 Lot number
STERILE EO Sterilised with Ethylene Oxide

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
9
5.0 INTENDED USE, WARNINGS, NOTES AND OPERATING PRECAUTIONS
INTENDED USE
The BodyGuard™ 545 Epidural Infusion Pump is intended to be used only for administraon via the epi-
dural or intrathecal route (collecvely referred to as neuraxial). BodyGuard™ pump fully complies with
the recommendaons of the NHS Naonal Paent Safety Agency (NPSA) that colour-coded epidural ad-
ministraon sets and dedicated epidural pumps should be used for applicaon via this route so as to
clearly disnguish them from equipment used for delivery via other routes (e.g. I.V.).
To minimise risk when administering neuraxial infusions the BodyGuard™ 545 Epidural Infusion Pump and
the dedicated administraon sets are yellow colour-coded to clearly denote the intended route of admin-
istraon.
Please ask your local representave or contact us direct for further details. Please ensure the pumps are
only used by, or under the supervision of trained medical sta.
WARNINGS AND NOTES
Warnings and notes will be seen throughout this manual. These are described as:
PRECAUTIONS
ABOUT THIS MANUAL
 The operator must be thoroughly familiar with the BodyGuard 545 Epidural Infusion Pump described
in this manual prior to use, and in parcular must read and understand any precauons stated herein.
If a soware change occurs and the operaon/specicaon for the pump changes, new or addional
operang instrucons will be issued, if needed. All illustraons used in this manual show typical
sengs and values that may be used in seng up the funcons of the pump. These sengs and val-
ues are for illustrave use only. The complete range of sengs and values are specied in the speci-
caons secon of this manual.
 This operang manual document has been developed with consideraon to the requirements in rele-
vant Harmonised Standards. Data presented in the Technical Specicaons reect specic test condi-
ons dened in this standard. Other external factors such as varying back pressure, temperature,
head height, set usage, uid restricons, soluon viscosity or combinaons of these factors, may re-
sult in deviaons from the performance data enclosed.
WARNING: Warnings advise of circumstances that could result in injury or death to the user/operator
or circumstances that could result in damage to the device. Read and understand this manual and all
warnings before operang the BodyGuard 545 Epidural Infusion Pump.
WARNING: Drugs must not be administered to the epidural space unless the drugs are indicated for
this purpose and are administered in accordance with the indicaons included in the manufacture’s
package. Epidural administraon of drugs other than those indicated for epidural use could result in
serious injury to the paent. For epidural administraon of drugs use the BodyGuard dedicated micro
set only.
NOTE: Indicates that the informaon that follows is addional important informaon or a p that will
help you recover from an error.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
10
OPERATING PRECAUTIONS
 Although the BodyGuard pump has been designed and manufactured to exact specicaons, it is not
intended to replace trained personnel in the supervision of epidural infusions.
 CME Medical will assume no responsibility for incidents which may occur if the product is not used,
stored or transported in accordance with the environmental condions spulated in this document
and on the package labelling.
 This infusion pump is designed for ambulatory use, and should withstand everyday handling. If the
pump is dropped onto a hard surface, or is suspected of being dropped, the operaon and calibraon
should be checked by a qualied technician.
 Do not bathe or shower whilst using the pump or immerse into liquid. The pump is resistant to a lim-
ited amount of splashing, but its construcon does not make it resistant to large amounts of spraying
or immersion in liquids. Damage to the internal components may result.
 The BodyGuard pump should be operated within a temperature range of +18ºC (+59ºF) to +45ºC
(+113ºF) and up to 85% humidity. Operang the pump at temperatures and/or humidity other than
within that range may aect accuracy.
 Do not operate the pump near high-energy radio-frequency eming equipment, such as electro-
surgical cauterising equipment. False alarm signals may occur.
INFUSION PRECAUTIONS
 Always read and follow the instrucons which accompany the administraon sets. Carefully follow
the instrucons for priming the set, as well as the recommended set change interval.
 The uid bag and administraon set should be disposed of in an appropriate manner, considering the
 nature of the residual uid that may be contained within, in accordance with the hospital/homecare
provider’s disposal pracces.
 Drugs for infusion by use of the pump may only be prescribed by a qualied medical praconer.
 Cauon must be exercised in the selecon of drugs and the amount and rate intended to be delivered
via any infusion pump.
 If the drug contained in the uid bag will be exposed to extreme environmental condions for pro-
longed me periods, it is important to select drugs that will not change pharmacologically upon such
exposure.
 As with all automac infusion devices, whenever a toxic or dangerous level of drug is stored in the
reservoir, constant monitoring of the infusion is required.
 In all applicaons, me to alarm under occlusion or other fault condions will depend on the infusion
rate and levels of alarm sengs. It is recommended to consider these parameters when using drugs
requiring infusion stability or low ow rates, and therefore a quick me to alarm.
 Disposables must be compable with the medicine delivered.
 When operang the pump on paent controlled programme with a rate of 0.00ml/h there is a hazard
of blood clot forming. Connecng a clear uid infusion in parallel will avoid this problem.
GENERAL PRECAUTIONS
 Do not use hard or sharp objects on the keypad.
 The specied accuracy of the pump can only be maintained if the pump is used, maintained and ser-
viced in accordance with the instrucons given in this manual. If the pump has failed to calibrate dur-
ing the servicing procedure, it must be returned for repair or disposal.
 If the pump is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise
suspected to have been damaged, remove it from service for inspecon by qualied personnel.
 The pump has been designed to be as safe as possible to handle; however, care should be exercised
to avoid trapping of ngers or other body parts in the mechanism.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
11
6.0 INSTALLATION AND SET-UP
PLACING AND REMOVING THE PUMP FROM THE CHARGING UNIT
PLACING THE PUMP INTO THE CHARGING UNIT
Put the pump into the charger top rst unl it clicks into place
REMOVING THE PUMP FROM THE CHARGING UNIT
Press the pump release buon to li the pump out of the charger boom rst
CHARGING THE PUMP
Connect the charger unit to AC power, the AC power indicator will be amber
Baery charging status Indicator
Verify that the indicator is lit: Green light = fully charged baery
Red light = baery charging
BATTERY AND CHARGING PRECAUTIONS
 Be sure that the baery is fully charged at all mes.
 Replace the baery once every two years.
 When the pump is not in use store the pump in the charger.
 Aer the “End Baery” signal has been acvated or following long periods of storage, wait 2 minutes
aer the pump has been connected to an AC power supply before operang.
 Do not operate the pump on AC power if the baery is not loaded in the pump for back up.
 Whenever possible, use the pump connected to an AC power supply via the charging unit. This pre-
serves the baery power supply for emergency use or for situaons where the AC power is not availa-
ble.
 The pump is protected against overcharging. In order to keep your baery fully charged, connect the
pump to the mains via the charger whenever possible.
 Blown fuses could cause a re hazard. Replace blown fuses on the charger only with fuses of the same
type and rang (see fuse values on the charger PCB).
 Baery charging is enabled as long as the charger cord is connected to the mains and the pump is in
the charger unit. Switching the pump o does not disconnect it from the mains. To disconnect from
the mains, remove the charger cord from the mains.
NOTE: Before using the BodyGuard pump ensure the baery is fully charged
WARNING: 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.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
12
MAINS POWER AND BATTERIES
The BodyGuard pump is powered by an AC (mains) power source. The pump uses external rechargeable
1800mAh Li-Polymer/Li-ion baery as an alternate power source. To assure connuous operaon, the
pump will switch from AC to baery power automacally in the event of AC power interrupon. The pump
also switches to baery power when disconnected from AC power. For example, if the paent needs to
ambulate, you can disconnect the pump from AC power and it will automacally connue operang on
baery power unl reconnected to AC power.
MAINS POWER AND BATTERY USAGE
 Do not operate the pump on AC power if the baery is not loaded in the pump for back up.
 The pump is protected against overcharging. In order to keep your baery fully charged, connect the
pump to the mains via the charger whenever possible.
 Switching the pump o does not disconnect it from the mains. To disconnect from the mains, remove
the charger cord from the mains.
 Whenever possible, use the pump connected to an AC power supply via the charging unit. This preserves
the baery power supply for emergency use or for situaons where the AC power is not available.
 Baery charging is enabled as long as the charger cord is connected to the mains and the pump is in the
charger unit.
 Replace the baery once every two years.
 Always make sure that the pump’s rechargeable baery is fully charged before using the pump for a
paent.
 A fully-depleted external rechargeable 1800mAg Li-Polymer/Li-ion baery takes about six hours to re-
charge. The baery level does not have to be empty for the baery to be recharged.
 To avoid complete loss of power, check the baery level frequently and recharge the baery if needed
using a BodyGuard pump baery charger.
 When the Low Baery alert condion occurs, connect the pump to the charger as soon as possible. You
have about 30 minutes before total loss of baery power.
 When the End Baery alarm condion occurs, connect the pump to the charger immediately otherwise
the baery will fail imminently.
 When the pump is not in use store the pump in the charger.
 Aer the “End Baery” signal has been acvated or following long periods of storage, wait 2 minutes
aer the pump has been connected to an AC power supply before operang.
FACTORS THAT AFFECT BATTERY LIFE
The actual baery life you experience depends on many factors. These factors vary among pump users,
according to how and under what condions they use the pump.
Factors that aect baery life include:
 Age of baery
 Infusion ow rate
 Other programmed infusion parameters
 Which pump features are used
 Ambient temperature in which pump is used
 How oen the pump display screen backlight is used
 How long the pump is le on, in Standby mode
 How long the baery is le uncharged before recharging
WARNING: Blown fuses could cause a re hazard. Replace blown fuses on the charger only with fuses of
the same type and rang (see fuse values on the charger PCB).
WARNING: 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.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
13
7.0 OPERATING THE BODYGUARD PUMP
7.1 SECURITY
Before performing any of the set-up and period tests or to operate, programme or congure the pump
you will need to access the pump using the security codes. As the BodyGuard pump is designed for pain
management therapies the pump has several levels of security to ensure safe set up and administraon of
pain protocols and to prevent idle or malicious tampering.
ACCESS CODES
To operate, programme and congure the BodyGuard pump three access codes are required.
Level One 700 Allows user to run pre-set protocols and trate infusion rate
(within pre-set protocol limits)
Level Two * Allows authorised users to deliver Clinician Acvated Bolus or loading dose
Level Three ** Allows users to set up or modify standard infusion protocols and change
pump conguraon parameters in ‘Change Set Up’
* / ** refer to senior clinical or lead service personnel for relevant code
A further code is used to access the technicians menu but this is only provided to fully trained (by CME
Medical) and authorised Electro-Biomedical Engineering departments.
Changes of pump set up and conguraon are changed via the BodyComm™ communicaons soware.
Code numerals can be changed and the code level applied to certain funcons can be changed if required.
KEYPAD LOCK
As a further, simple security feature you can also lock the keypad.
1. Whilst the pump is infusing press and hold unl the Lock Mode chart which the pump
displays goes from OFF to ON
2. This now prevents the operaon of all keys except and
3. To unlock the keypad press and hold again unl the chart goes from ON to OFF


NOTE: To prevent unauthorised individuals accessing the main menu a technique is required to return
to the menu code screen when the pump is in STOP mode.
To return to the menu during infusion: press STOP (to stop delivery and enter the STOP state).
Press and hold STOP unl the ‘Resume or Menu’ choice prompt appears.
NOTE: When keypad lock is on, entering the stop state and holding down STOP will not return you to
the main menu. Press START (to restart the infusion), press and hold INFO (to remove keypad lock),
then press and hold STOP unl prompted for the access code to return to the main menu.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
14
7.2 SETTING UP AND MODIFYING PROTOCOLS
When you receive your BodyGuard pump and go to ‘Modify Protocol’ on the main menu for the rst me
you will see that all protocols are blank. You can edit, add or delete up to a maximum of 26 infusion pro-
tocols to tailor the protocols to your service (CME Medical can pre-programme if requested).
From the main menu you access “Review Set up” and “Change set-up” to view and set local preferences
for device conguraon from the opons available. Some inial sengs may need to be acvated from
the Technicians menu or BodyComm™ communicaons soware.
This secon is probably the most complex of the manual but remember you should only have to perform
this funcon once for each protocol with each pump whilst you are seng it up for use on the rst few
paents. You may also ask CME Medical representaves or service personnel to assist with the set up of
the pump which can be done prior to delivery.
Each protocol requires the following data (depending on inial set up):
A. Drug/Protocol name (up to 18 characters)
B. Volume to be infused (VTBI)
C. Inial infusion rate in ml, mg or mcg per hour. This step and the protocol maximum rate step will be
hidden if the pump has been set to 0ml maximum basal rate by the technical sta.
D. Protocol Maximum rate (to allow traon within protocol)
E. Bolus volume (if applicable)
F. Maximum bolus
G. Lock Out between boluses (if applicable) Drug concentraon (oponal)
H. Programme Limits: MediGuard and volume/bolus limit (choice of 0, 1, 4 or 24h limit of either volume
boluses set up) Set under “Change Set Up” as applicable.
NOTE: You can use protocols to set up several commonly used treatment regimes in your service i.e.
same bag, drug name, basal rate but dierent bolus volumes or lockout mes.
NOTE: Each protocols parameters are unique to that protocol. For example if you use both Ropivacaine
and Bupivacaine in your service and one commonly comes in a 100ml bag whilst the other is in a 250ml
bag then you can set these bag sizes as standard for each.
NOTE: Aer seng up your most common regimes as a protocol set up the next or last protocol leer
as a ‘Tailored’ or one o regime that you can modify for individual paents who don’t fall within the
pre-set protocols. Once the infusion has been administered for a parcular paent you can go back in
and change this for the next or a future paent.
NOTE: Entry of all parameters is via the numeric keypad. Only the protocol selecon is a scroll opon
menu using the UP and DOWN arrows. The previous value will be displayed. Enter the new value, which
will automacally delete the previous value. If you make an error whilst entering, pressing STOP will
delete the previous digit. Repeat as necessary.
NOTE: At certain screens, if you delay for a period of me between key presses the pump will revert to
the previous screen.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
15
PROGRAMMING DRUG/REGIME PROTOCOLS
1. From the main menu select “Modify Protocol” and press
2. Enter Access Code and press
3. Scroll to select the protocol for adding/modifying, (A to Z) press
If seng up protocols for the rst me, the protocol inial only will be
visible.
A. DRUG/PROTOCOL NAME
4. To enter the edit mode and add a protocol name press
If you need to delete a protocol name previously entered press
connuously unl the cursor is at the le side of the display.
Even if the name appears empty you must sll perform this step as the line is full of blank spaces.
5. Use numeric keys 2 (up), 4 (le), 6 (right) and 0 (down) as cursor keys to navigate around the leer,
number and symbol choices.
To select a character, posion the white cursor over the target leer/number/symbol, press
Repeat the last step as required to build your protocol name.
To add a space, posion the cursor in the top le blank space of the grid and press
The maximum name size is 18 leers/digits including spaces.
6. When you have nished building your protocol name posion the cursor in the top right side,
press to conrm your new Protocol name:
Then either:
7. Press to accept your new name and return to protocol selecon or
8. Press to return to edit mode
A:
B:
C:
D:
E
P
I
Level Three Code
...............................
Enter and Press OK
E
P
I
Change Bag
=>Modify Protocol
Event Log
P
A
Protocol A
P
A
Protocol A
Bupiv + Fent
NOTE: The BodyGuard pump has a system called MediGuard which can be acvated under ‘Change Set
Up’, Program Limits’. When this feature is set to ‘ON’ the pump will ask for the paents weight at the
stage of entering the protocol. If disabled you will skip this stage. Refer to Appendices for instrucons
for seng up protocols with MediGuard enabled.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
16
9. By returning to edit the protocol list (A to Z) displays:
Select the protocol to edit, press
B. VTBI
10. Enter bag volume in ml, press
To change any numeric programme parameter just enter the numbers which will replace the previous
value and this will overwrite the previous value.
11. If you make a mistake whilst entering, press to delete the last digit entered
Press when correct value is entered
C. INITIAL INFUSION RATE (ml/h)
12. Enter the inial rate using the numeric keypad, press
If the rate step does not appear then the Maximal Rate under ‘Change Set Up’ has been set to 0ml/h
to prevent users from delivering regimes with a connuous element. If you have the authority to
change this go to ‘Change Set Up’ (see later secon).
D. PROTOCOL MAXIMUM RATE
13. This will have defaulted to the inial rate you have just set. Enter the maximum rate you will allow for
this protocol, press
For example, you may wish to start an epidural with 6ml/h but allow users to trate up to12ml/h.
NOTE: BodyGuard pump is capable of connuous (basal) rates of up to 30ml/h. Users can x a maxi-
mum basal rate in ‘Change Set Up’ using the Level Three access code to ensure other users cannot
accidentally programme the pump to deliver above the safe ceiling for your commonly used drugs.
NOTE: To programme in mg/h or mcg/h:
Press STOP 4 mes respecvely (rst press clears the previous rate, second asks if you want to accept
“ml only” and third takes you to concentraon mg/ml screen. A further press takes you to mcg/ml).
To specify the concentraon in mg or mcg/ml of the drug regime you are programming, use the
numeric keypad to enter the value (i.e. 1mg/ml). Press START/OK when done.
A: Bupiv + Fent
B:
C:
D:

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
17
E. BOLUS VOLUME (if applicable)
14. Change or accept the bolus volume using the numeric keypad, press
F. MAXIMUM BOLUS
15. Enter the maximum bolus, press
G. LOCK OUT BETWEEN BOLUSES
16. Change or accept the Lock Out (bolus lockout interval) in minutes, press
H. PROGRAMME LIMITS
17. Change or accept the 0, 1, 4 or 24 hour limit. To turn the limit o enter ‘0’, press
Depending on how this has been congured under ‘Change Set Up’ in ‘Programme Limits’ the pump
will ask you to set the limit in either volume (ml), concentraon (mg or mcg) or number of boluses.
If MediGuard is enabled, refer to Appendices for MediGuard Set Up.
18. You can now conrm or review the sengs entered:
If sased with protocol sengs, press
This will return you to the main menu screen, “Select Protocol”
If you wish to review or change your sengs, press
This will return you to the Protocol list (A to Z) selecon screen to
connuously run through and check/change your entries before arriving back at the ‘Conrm’ or
‘Review’ screen.
NOTE: If the screen does not appear, then the opon is set to o in "Change set up" (zero hour limit is
the default).
Conrm: Press OK
Review: Press NO
WARNING: Before the pump is put into use check the defaults (by selecng ‘Review Set Up’ from the
main menu) are appropriate for your intended use. Sengs can be changed in ‘Change Set Up’ using
the relevant code. CME Medical recommend this is done only by the lead clinical person or your local
electronic engineering department. Please see the later secon on ‘Change Set Up’ for further
informaon.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
18
7.3 DEDICATED BODYGUARD ADMINISTRATION SETS
Only dedicated BodyGuard administraon sets should be used with BodyGuard pumps. All BodyGuard
micro sets incorporate the following features:
 Latex-free, micro bore an-kink tubing to prevent occlusion parcularly in ambulatory conguraon.
 Colour-coded (yellow-epidural) to aid idencaon of administraon route.
 Pumping segment non-colour coded, secon containing the key block, visible on the pumping
segment ensures set can only be installed correctly (for direcon of ow) and that only dedicated
sets (calibrated to the pump to ensure accuracy) are used
 Check valve (an-siphon/an-reux) at the distal end of the set
 Choice of straight or angled spikes
Straight
spike
Angled
spike
230cm, colour coded (yellow), epidural administraon spike set with approximate 5ml priming capacity.
ANTI-FREE FLOW VALVE
The An-Free Flow valve enhances pump funconing by:
 Prevenng free-ow in the event the set is detached from the pump
 Prevenng back-ow (reux) in the event several infusion pumps are connected simultaneously to the
same paent
 Prevenng free-ow in the event of a mechanical malfuncon
 The mechanism along the inner door side of the pump maintains opmal accuracy even if the line is
used over several days
WARNING: All BodyGuard dedicated administraon sets incorporate secons of PVC tubing and the
pumping segment is polyurethane/silicone. Do not use pharmaceucals with this device that are not
compable with either PVC or polyurethane administraon sets.
WARNING: Use of administraon sets other than dedicated sets may impair the operaon of the pump
and accuracy of infusion. Do not operate the BodyGuard pump with any set other than those supplied
by CME Medical or through their distribuon partners.
NOTE: A kinked/occluded administraon set may impair operaon of the pump and the accuracy of the
infusion. Before operaon, verify that the set is not kinked or occluded. BodyGuard sets are manufac-
tured from kink resistant tubing.
WARNING: BodyGuard sets are designed specically for ambulatory epidural use. They have a set
capacity of c.5ml for safety reasons. Normal hospital lines can hold up to 16ml of uid which is not
appropriate when administering potent agents such as morphine. Non-colour coded sets are available
on request.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
19
7.4 LOADING THE ADMINISTRATION SET
1. Prepare uid bag and aach to administraon set.
2. Open the BodyGuard pump door (using latch on right side of door).
3. The clear, silicone secon of the administraon line ts into the pump. Hold this secon of tubing
with the key (small plasc block) on the right and make sure the ow direcon is in line with the ow
direcon arrows inside the pump door.
4. Insert the BodyGuard administraon set into the pump by placing the key into the keyway making
sure the protrusions face upwards. Close the pump door unl the catch clicks.
WARNING: Use asepc technique. Paent infecon may result from the use of non-sterile
components. Maintain sterility of all disposable components and use single use consumables marked
once only.
WARNING: The key can only be ed into the keyway one way. If you are having trouble ng it do
not force it in. Check to ensure you have correctly lined up the tubing with the direcon of ow.
WARNING: Do not aach the set to the paent’s access device before priming the administraon set.

CME Medical BodyGuard™ 545 Epidural Infusion Pump Operaon Manual/Rev 2.3/October 2013
20
PRIME
0 6
(Press NO to Stop)
7.5 POWERING UP AND PRIMING A SET
1. Once the set is loaded turn on the BodyGuard pump by pressing
2. During power up these screens display
automacally to conrm pump soware
version and pre-set limits
3. Press to resume a previous infusion (retain paent history) or
Press to take you to the main menu
4. Enter Level One access code, press
5Ensure the cursor is poinng to ”Prime”, or scroll to if necessary (the
text appears in a larger font), press
6. The screen prompts you to check and ensure the pump is disconnected
from the paent, to commence priming press
7. The chart now displays the progress versus total pre-set priming
volume.
You may stop priming at any me or repeat the last two steps if
the line is not completely primed aer rst priming funcon.
8. On compleon of priming the screen displays the main menu
BodyGuard
XXXXX
Limit OFF
Air Alarm 0.5 ml
Occlusion XX psi
WARNING !!
Disconnect Paent
Press OK to Prime
E
P
I
Press OK to Resume
Press NO for Menu
E
P
I
Level Three Code
...............................
Enter and Press OK
E
P
I
=> Prime
Select Protocol
Change Bag
E
P
I
Prime
=> Select Protocol
Change Bag
NOTE: The priming volume and rate can be changed in via the “Change Set Up” opon in the main
menu. Increasing the priming rate may cause excessive turbulence in the set on priming and make it
dicult to purge all air from the system. CME Medical recommend a priming rate of <425ml/h.
NOTE: All BodyGuard administraon sets contain a check valve which means the line cannot be primed
using gravity. Sets must be primed using the infusion pumps priming funcon.
NOTE: Priming volume is user congurable depending on the capacity of the administraon sets in
regular use in your service. For epidural sets, a 6ml prime volume is suggested.
WARNING: Do not aach the set to the paent’s access device before priming the administraon set.