BodyGuard 575 Operator Manual Rev 100-095XCV Feb 2013

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

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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

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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



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)

o Utilize Wi-Fi technology (optional) Button Descriptions and Functions  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

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Keypad Descriptions and Functions Front of BodyGuard® PCA infusion pump:

7 1 4

6

3 8

5

10

2 9

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 Software ver. CVPCA30E_1

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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

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BodyGuard® Infusion Pump with Door open

1 8 7 8 9

2 3 4 5

# 1.

Area Latch Holder

2.

Pressure Sensor

3.

Keyway

Function Holds the door closed when latch is in vertical position. Detects downstream tubing restriction and occlusion. Alarm level can be adjusted to suit patient needs. 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).

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The Charger

1

2

# 1.

Area Charger Display

2.

Release Handle

Software ver. CVPCA30E_1

Function Displays major pump messages and operation values. Push to release the pump from the Charger.

8

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 reconfirm 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

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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

STERILE EO

Lot Number Sterilized with Ethylene Oxide

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Terms Used In Manual Warning: Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand this manual and all warnings completely before operating the BodyGuard® 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 colorcoded 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

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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

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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.)

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3 – Installation and Set up

Unpacking 1.

Carefully remove the pump and Charger from the box.

2.

Make sure no items were damaged during shipment

3.

Make sure you have the following items: 

BodyGuard® 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.

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Charging the Pump 

NOTE:

The pump is protected against overcharging. In order to keep your battery fully charged, connect the pump to the mains via the Charger whenever possible. Be sure that the 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.

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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 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. When priming is completed, wait 2 minutes without pressing any key. After two minutes the screen displays “Pump Paused Too Long” and an

6.

until the Self-Test screen appears. If air sensor is off, press

alarm will sound. Press again or

to silence the alarm

to exit alarm condition.

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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.

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

3.

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 NOTE: 0.1 ml/hr to 11 hours Theup 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.

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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.

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5.

Wait untill pump displays “low battery” message

6.

Press

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.

to turn the pump off.

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.

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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.

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