CME BodyGuard 323 User manual

4 (2)

BodyGuard 323

Infusion Pump System

Operator Manual

0344

Manufacturer:

Caesarea Medical Electronics Ltd. European address:

Staufenburgstr. 23 Lichtenstein P.O.B. 1248 Lichtenstein 72805 Germany

International Toll Free: +800-323-575-00 www.cme-infusion.com

Contact e-mail: Sales@cme-infusion.com

EDITION July 2009	Ref.: 100-090X

NOTE: To assure proper use of the BodyGuard, Caesarea Medical Electronics Ltd. urges

all users to read this manual carefully, become familiar with the procedures and system functions and follow all recommendations.

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.

U.S.A. federal law restricts this device to sale by or on the order of a physician.

BodyGuard Operator Manual

Table of Contents
1- Introduction................................................................................................	5
Overview.................................................................................................	5
Button Descriptions and Functions .....................................................	5
BodyGuard Pump with Door Open.......................................................	8
The Charger............................................................................................	9
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
Cautions ...............................................................................................	18
3 – Installation and Set up...........................................................................	19
Unpacking ............................................................................................	19
Charging the Pump..............................................................................	20
4 – Operation................................................................................................	21
Before Operating the Pump ................................................................	21
Pump Operation Test...........................................................................	21
Air in Line – Alarm Test.......................................................................	22
Down Occlusion – Alarm Test ............................................................	22
Door Open – Alarm Test......................................................................	23
Battery Test ..........................................................................................	24
Charger Indicator Test.........................................................................	24
Dedicated BodyGuard Administration Sets ......................................	25
The BodyValve .....................................................................................	25
Loading the Administration Set..........................................................	29
Priming the Line...................................................................................	30
Prime – In Continuous, Intermittent, TPN , and 25 Steps Modes.....	30
Prime – In PCA Mode...........................................................................	31
Prime Operation – After Air In Line Alarm .........................................	32
Manual Prime Operation......................................................................	32
Operation steps....................................................................................	33
Pump Mounted on IV Pole...................................................................	33
Portable Connection............................................................................	33
Programming........................................................................................	34
Changing Current Program – Using Level 1 Code............................	35
Changing Current Program – Short Way...........................................	35
Continuous Infusion............................................................................	36
Intermittent Infusion ............................................................................	41
Program Delay......................................................................................	46
25 Steps Protocol................................................................................	48
TPN Infusion.........................................................................................	50
PCA Infusion ........................................................................................	53
Setting Pressure Default For Down Occlusion..................................	64
BodyGuard Operator Manual	3

	Lock Mode............................................................................................	65
	How To Lock.........................................................................................	65
	Info Mode..............................................................................................	67
	Review Set up.......................................................................................	69
	Change Set up......................................................................................	70
5	– Alarm Conditions and Troubleshooting...............................................	72
	Alarm Condition...................................................................................	72
	Troubleshooting...................................................................................	73
6	– Specifications.........................................................................................	75
7	– Service and Maintenance ......................................................................	77
	Cleaning................................................................................................	77
	Storage .................................................................................................	77
	Battery Operation.................................................................................	78
LIMITED WARRANTY...................................................................................		79

BodyGuard Operator Manual

1-Introduction

1- Introduction

Overview

The BodyGuard System provides the following features:

Small, light and compact pump.

Multiple Programs:

Continuous

Infusion Rate: 0.1 to 1200 ml/hr

Volume: 0.1 to 99.9 ml in 0.1ml increments or 1 to 9999 ml in 1ml increments

Secondary Infusion (Piggy) programmable with the same infusion rate and volume capabilities as the primary continuous infusion.

Intermittent

TPN

PCA

A set dose delivered in set intervals. Between Intervals the pump will keep vain open (KVO Mode).

Total Parenteral Nutrition Rate Taper program with programmable up and down times.

Patient Control Analgesia: Continuous delivery plus /or programmed boluses.

Bolus Volume: 0-25.5 ml Clinician Bolus Volume: 0.1-100ml Bolus Rate: 0.1-1200 ml/h

25 Steps

Operator can design a specific protocol for drug delivery which contains up to 25 steps. Infusion Rate: 0.1 to 1200 ml/hr

Volume: up to 9999ml, for each step Accumulated Volume for all steps – up to 10 liters.

Highly accurate fluid delivery

Operated with a custom safe administration set

Rechargeable internal lithium-ion battery or alkaline 2X9V batteries

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

AEA – Suitable to be used in ambulances.

BodyGuard Operator Manual

1-Introduction

Front of BodyGuard 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

BodyGuard Operator Manual

1-Introduction

5. PRIME/BOLUS

•Pressing Prime/Bolus key during data setting: Enables Priming procedure. A graph appears on the display screen showing the priming volume with the current value increasing until reaching the set volume.

•Pressing Prime/Bolus key during Continuous program operation: Enables Secondary (Piggy) Infusion.

•Pressing Prime/Bolus key during PCA program operation: Enables bolus procedure.

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 (If needed).

9. Down Arrow

•Scrolls down through options

10. Numeric Keys

•Enters numeric parameters during programming

BodyGuard Operator Manual

1-Introduction

BodyGuard Pump with Door Open

		1
	7	6
		2
	8
		3
	9

#	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 IV line

4.	Pressing Plate	Connected to the door by two springs

5.	Pump Door	Covers the pressing plate

6.	Flow Direction	Shows direction of pump operation

7.	Anti-Stretch locator (Optional)	Locates the tube in the correct length from the key

8.	Air sensor – Front	Ultrasonic air detector, which is mounted on the front
		housing.

9.	Air sensor - Door	Mounted on the door

BodyGuard Operator Manual

1-Introduction

The Charger

#	Area	Function

1.	Charger Display	Displays major pump messages and operation values.

2.	Release Handle	Push to release the pump from the Charger.

BodyGuard Operator Manual

1-Introduction

System Safety Checks

The following details outline the safety checks designed into the BodyGuard infusion system, 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.

Air-in-Line Accumulation

To improve the detection of air in the IV line, the BodyGuard 323 Infusion system utilizes an air-in-line accumulation system in addition to the standard single bubble detection. This feature monitors the volume of air that passes through the IV line by accumulating the volume of individual bubbles over any 15 minutes period. This limit is not configurable. Although an individual bubble may not exceed the preprogrammed threshold, if the cumulative volume of smaller bubbles exceeds 1ml over a period of 15 minutes an air-in-line alarm is initiated. This accumulation feature is particularly useful with infusions for patients who are highly sensitive to air (i.e. infants, neonates, children) or when infusing products that create significant volumes of small air bubbles.

Anti-Bolus Function

The anti-bolus function is designed to reduce the bolus that may occur upon the release of an occlusion following a downstream occlusion alarm. Upon the detection of a downstream occlusion, the alarm is activated and the pump returns the IV line pressure to neutral within 15 seconds. Neutral line pressure is achieved by the reverse operation of the pumping mechanism, and measurement of the IV line pressure through the in-line pressure detection system.

BodyGuard Operator Manual

1-Introduction

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 (720 F). 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 323, as with all infusion systems, the action of the pumping mechanism and variations cause short term fluctuations in rate accuracy.

The following curves show typical performance of the system in two ways:

1.The accuracy of fluid delivery over various time periods is measured (trumpet curves).

2.The delay in onset of fluid flow when infusion commences (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.

BodyGuard Operator Manual

1-Introduction

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.

BodyGuard Operator Manual

1-Introduction

BodyGuard Operator Manual

1-Introduction

BodyGuard Operator Manual

2-Symbols, Warnings and Cautions

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

CE mark indicates conformance to Medical Device Directive 93/42/EEC

0344

LOT

STERILE EO

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

BodyGuard Operator Manual

2-Symbols, Warnings and Cautions

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, 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 therapy in hospital and home care environments.

Warnings

To avoid possible personal injury or loss of life, observe the following:

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.

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).

BodyGuard Operator Manual

2-Symbols, Warnings and Cautions

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 (to complete it).

Make sure the pump is attached securely to the Charger, which is connected firmly to an IV pole.

A kinked or occluded IV line may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the IV line is not kinked or occluded.

The BodyGuard should be operated only with the Bodyset IV lines. Use of IV lines other than the Bodyset 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.

Use aseptic technique. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components and do not re-use single use IV sets.

Watch your fingers 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.

Do not operate the pump near high-energy radio-frequency emitting equipment, such as electrosurgical cauterizing equipment. False alarm signals may occur.

BodyGuard Operator Manual

2-Symbols, Warnings and Cautions

Do not let the pump operate when battery is fully depleted. Pump may turn off during operation on fully depleted battery without alarm.

Never operate the pump without performing the battery test as described in chapter 4 in this manual.

Do not use the BodyGuard 323 for infusion of Insulin or for infusion of blood.

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 store the pump with the battery fully depleted.

Xylene, Acetone or similar solvents could cause damage to components. Do not clean the pump with these chemicals. Clean solution spills on the pump immediately. Use a damp cloth or sponge. A mild detergent may be used. Wipe thoroughly with a dry cloth.

Immersing the BodyGuard Infusion pump into liquid could cause damage to components. Do not immerse the pump into any type of liquid.

Battery damage could occur if left in a temperature warmer than 500C (122°F).

BodyGuard Operator Manual

3- Installation and Set up

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

•PCA bolus cable (optional)

•9V Alkaline Battery compartment (optional)

•Disposable Battery Pack (optional)

•External charger (optional)

•Extended life battery Li-Ion Polymer 3600 mAh (optional)

•External wall charger (Optional)

If any items are missing or damaged, contact your BodyGuard supplier.

BodyGuard Operator Manual

3- Installation and Set up

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 8 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) and lift the pump out of the charger bottom first.

Caution: Leaving the battery fully depleted for a long period of time may damage the battery.

BodyGuard Operator Manual

4 - Operation

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.The program selected and its status are displayed. 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.Press to prime the IV line.

Warning: Ensure the set is not connected to a patient!!

6.Enter the Volume of fluid required to prime the set and press to begin priming procedure. You may stop priming at any time by pressing .

7.The display screen will show a graph indicating the prime operation.

PRIME

Disconnect Patient

Press OK to Start

Prime Vol __ ml

Press OK to Continue

PRIME	5 ml

0	5

BodyGuard Operator Manual

4 - Operation

8.When priming is completed, wait 2 minutes without pressing

any key. After two minutes the screen displays “Pump Unattended” and an alarm will sound. Press to silence the alarm again or to exit alarm condition.

Pump Unattended

Press OK to Start

Air in Line – Alarm Test

1.Insert a BodySet administration set and close the pump 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.The pump displays the program selected and its status. The display will automatically change to display the last rate setting.

4.Change the infusion mode to Continuous (See “Change

Set up” Section for instructions). Set the infusion rate at

500ml/hr, using the Numeric keypad and press to confirm setting.

5.
Set Volume at 20 ml and press	to start operation.

Rate 500 ml/h

Press OK to Continue

Volume 20 ml/h

Press OK to Continue

6.Insert air into the IV line to allow an air bubble greater than 10 mm to enter into the administration set.

7.Air in line alarm will be activated as soon as the air bubble Air /Up Occlusionenters the set segment located behind the pump door.

Press to turn the alarm off.

Press STOP to Mute

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.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.The pump displays the program selected and its status. The display will automatically change to display the last rate setting.

BodyGuard Operator Manual

4 - Operation

5.Change the infusion mode to Continuous (See “Change Set

up” Section for instructions). Set the infusion rate at 500 ml/hr using the Numeric keypad and press .

6.Set Volume at 20 ml and press to start operation.

Rate	500 ml/h
Press OK to Continue
Volume	20 ml

Press OK to Continue

7.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)

8.Wait another 5 minutes and occlude the IV line downstream of the pump (between the pump and the pressure gauge).

9.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).

10.Depending upon the set flow rate and pressure threshold, the Down Occlusion alarm will be activated.

11.Press to mute the alarm.

Down Occlusion

Press STOP to Mute

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.The pump displays the program selected and its status. The display will automatically change to display the last rate setting.

4.Change the infusion mode to Continuous (See “Change Set

up” Section for instructions). Set the infusion rate at 500ml/hr using the Numeric keypad and press .

5.Set Volume at 20 ml press to start operation.

6.Open the pump door.

7.Door Open alarm will be activated at once.

8.Close the door and press .

Rate	500 ml/h
Press OK to Continue
Volume	20 ml

Press OK to Continue

Door Open

Close Door

BodyGuard Operator Manual

4 - Operation

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.The pump displays the program selected and its status. The display will automatically change to display the last rate setting.

5.Change the infusion mode to Continuous (See “Change Set

up” Section for instructions). Set the infusion rate at 1200		Rate	1200 ml/h
ml/hr using the Numeric keypad and press	.	Press OK to Continue

6. Set Volume at 9999 ml and press	to start operation.	Volume	9999 ml

Press OK to Continue

7.Wait untill pump displays “low battery” message

Low Battery

Connect to Charger

8.Press to turn the pump off.

9.Connect the pump to a charger.

10.Verify the red icon of battery is lit (on the charger).

11.Verify the red battery turns green after a minimum of 2 hours.

WARNING: Do not let the pump operate when battery is fully depleted. Pump may turn off during operation on fully depleted 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.

BodyGuard Operator Manual

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