BodyGuard Operator Manual 323 Ref CV 100-090XCV June 2012

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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.

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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 ... 24 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

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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

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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

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

TPN

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

PCA

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.

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Highly accurate fluid delivery

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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

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Free flow protection valve standard on every CME administration set

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Quiet operation

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Used for ambulatory care in a carrying pouch or mounted on an IV pole

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AEA – Suitable to be used in ambulances.

Button Descriptions and Functions

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1-Introduction

Front of BodyGuard Infusion Pump 10 5 6

1 2 3 4

7

9

8 1. Display Screen  

Displays pump and infusion status Displays programming choices and instructions

2. STOP/NO     

Stops infusion Silences an alarm condition Pause priming Zeroes the displayed value during programming Returns to previous screen

3. START/ OK  

Starts infusion Confirms selection and setting

4. PRIME/BOLUS   

BodyGuard Operator Manual

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.

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1-Introduction

5. 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 red and a beep is generated.

6. Lock Operation 

Will lock keys to prevent settings changes.

7. 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).

8. Numeric Keys 

Enters numeric parameters during programming

9. Arrows 

Scrolls up, down, right and left through options

10. 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

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1-Introduction

BodyGuard Pump with Door Open

1 6

7 8 9

2 3 4 5

#

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

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1-Introduction

The Charger

1

2

#

Area

Function

1.

Charger Display

Displays major pump messages and operation values.

2.

Release Handle

Push to release the pump from the Charger.

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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.

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1-Introduction

Pump Accuracy The following graphs and curves were derived from testing described in IEC60601-2-24. Testing was 0 performed under normal conditions at room temperature (72 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.

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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.

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1-Introduction

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1-Introduction

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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 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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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.

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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:

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

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).

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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.

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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. 0

Battery damage could occur if left in a temperature warmer than 50 C (122F).

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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.

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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.

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