BodyGuard 595 Color Vision Operator Manual Rev 1.0 Oct 2014

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NOTE: to assure proper use of the BodyGuard 595 Color Vision™, 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 Overview Keypad Descriptions and Functions System Safety Checks Pump Accuracy 2 – Symbols, Warnings and Cautions System Symbols Terms Used In Manual Intended Use Warnings 3 – Installation and Set Up Unpacking Charging the Pump 4 – Operation Before Operating the Pump Pump Operation Test Air in Line – Alarm Test Down Occlusion – Alarm Test Door Open – Alarm Test Battery Test Charger Indicator Test Operating the Pain Manager Infusion Pump Access Codes & Keypad Lock Keypad Lock Dedicated Administration Sets The BodyValve™ MicroSet™ with 0.2mic Filter Loading the Administration Set Priming the Set Modify Protocol Select Protocol (start an infusion) Titrating Basal Rate During Infusion Patient Activated Bolus Clinician Activated Bolus Automatic Bolus Rate Adjustment Interpreting the Display Screen During Infusion MediGuardTM Option Using History Functions End of Program/Infusion and Bag Change Eliminating Air During Operation Down Occlusion Alarm View Set Up Change Set Up Default Settings 5 – Alarm Conditions and Troubleshooting Alarm Condition Troubleshooting 6 – Specifications 7 – Service and Maintenance Cleaning BodyGuard 595™Color Vision Operator Manual

5 5 6 10 11 15 15 16 16 16 19 19 20 22 22 22 23 23 24 24 25 25 26 26 27 28 29 29 30 32 43 47 47 48 52 52 53 54 56 57 58 59 59 60 62 62 63 65 67 67 3

Storage Battery Operation LIMITED WARRANTY

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1 – Introduction

1 - Introduction Overview The BodyGuard 595 Color Vision™ Pain Manager System provides the following features: 

Compact design, lightweight pump.



Infusion Programs:  Basal only  Basal & bolus  Bolus Bolus can be one of the following:  Patient bolus  Auto bolus  Patient bolus combined with auto bolus Program Modes:  PCA  Epidural  Regional

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Highly accurate fluid delivery

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Operated with a custom safe administration set

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Large multi-color display for enhanced visibility

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Wi-Fi capability (802.11) – upload/download real time data from the pump - manipulate pump from distance (optional)

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Rechargeable internal lithium-ion battery

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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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2000 event log plus detailed patient history.

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Ability to output history to PC (printer or file) using BodyCommTM software (optional) 

Utilize Wi-Fi technology (optional)

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Prevents false occlusion alarms when delivering boluses through a EPIDURAL or PCA catheter by automatically varying bolus delivery rate.

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Post-Occlusion Bolus Prevention System

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Uses color coding system (on the set and pump display) to enhance safety

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MediGuardTM protection ensures protocol is appropriate to patients weight

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1 – Introduction

Keypad Descriptions and Functions Front of BodyGuard 595 Color Vision™ Pain Manager

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1. Operation LED  Green Indicator  Lights during system Self-Test  An intermittent green light indicates infusion delivery  Red Indicator 2. Display Screen  Indicates an alarm state with a continuous red light  Displays pump status Lights when and the infusion pump is in a stand-by mode during  Displays programming choices and instructions programming  Deferent title bar color for each program (Blue- PCA, Yellow- EPIDURAL, Green- REGIONAL) 3. Power ON/OFF  Turn the system ON by pressing and holding the button until the Self-Test screen appears. TurnOperation the system OFF by pressing and holding the button 4. Lock until the graphtoisprevent black and a beep is generated.  Will lock keys settings changes.   Pause priming  Zeroes the displayed value during programming  Erases the last digit during programming 6 BodyGuard 595™Color Vision Operator Manual  Returns to previous screen

1 – Introduction

5. INFO  Supplies information about the pump and its programs (see Info Mode chapter). Pressing continuously locks and unlocks the keypad to 6. Numeric Keys prevent accidental or deliberate change to pump operation. Enters numeric parameters during programming 7. STOP/NO  Stops infusion  Silences an alarm condition Pause OK priming 8. START/ Zeroesinfusion the displayed value during programming  Starts Erases theselection last digitand during programming  Confirms setting  Returns to previous screen 9. BOLUS  Change bolus parameters during operation (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. 10. Arrows  Scrolls up, down, right and left through options

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1 – Introduction

BodyGuard 595 Color Vision™ Pain Manager with Door Open

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Area

Function Holds the door closed when latch is in vertical position.

1.

Latch Holder

2.

Flow Direction

Shows direction of pump operation.

3.

Pressure Sensor

Detects downstream tubing restriction and occlusion. Alarm level can be adjusted to suit patient needs.

4.

Keyway

Guides the administration line.

5.

Pressing Plate

Connected to the door by two springs.

6.

Pump Door

Covers the pressing plate.

7.

Anti-Stretch locator

Locates the tube in the correct length from the key (Optional).

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

BodyGuard 595 Color Vision™ Pain Manager Charger

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2

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Area

1.

Charger Display

2.

Release Handle

BodyGuard 595™Color Vision Operator Manual

Function Displays major pump messages and operation values. 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 595 Color Vision™ 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 595 Color Vision™ 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 1100mmHg (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 595 Color Vision™ utilizes two modalities to detect air-in-line. The ultrasonic detector can be configured between 0.0 (OFF in epidural mode only) & 1.0ml on the BodyGuard 595 Color Vision™ pump for single bubble detection whilst a cumulative check triggers the alarm if an accumulation of smaller bubbles totals 1.0ml (nonconfigurable) 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 or 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 MediGuardTM 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 MediGuardTM feature is on users are asked to set the patients weight (kg) and a toxicity ceiling in ml, mg or mcg per hour per kilogram bodyweight. If users try to set a protocol where the component elements (basal rate and boluses) exceeds the MediGuardTM limit the pump will alert the user to this and request they re-confirm their intentions, amend or revise the toxicity ceiling. Level One user 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 authorization. Under Program Limits you can choose to limit the bolus volume over either a 1, 4, or 24 hour period according to local practice.

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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/220 C). 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 60601-224 standard.

Trumpet and Flow Rate With the BodyGuard 595 Color Vision™, 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: The accuracy of fluid delivery over various time periods is measured (trumpet curves). 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. Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short-term fluctuations in rate accuracy BodyGuard 595™Color Vision Operator Manual

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1 – Introduction

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 595 Color Vision™ Pain Manager 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.

Caution, consult accompanying Instructions

Attention, refer to operating instructions

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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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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 595 Color Vision™ Pain Manager. 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 595 Color Vision™ Pain Manager.

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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 595 Color Vision™ Pain Manager.

Intended Use The BodyGuard 595 Color Vision™ Pain Manager 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. The BodyGuard 595 Color Vision™ Pain Manager Infusion Pump is designed for patients who require Epidural, Regional or PCA pain management. 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 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. BodyGuard 595™Color Vision Operator Manual

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2 – Symbols, Warnings and Cautions

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 595 Color Vision™ should be operated only with the MicroSetTM administration lines. Use of administration lines other than the MicroSetTM 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 MicroSetTM only. Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the BodyGuard 595 Color Vision™ Pain Manager 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 595 Color Vision™ Pain Manager should be operated within a temperature range of 10C (50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. Pump should be stored with the battery connected, otherwise the internal rechargeable battery may lose track of actual time. Dropping the BodyGuard 595 Color Vision™ Pain Manager could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel.

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2 – Symbols, Warnings and Cautions

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

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 595 Color Vision™ Infusion Pump

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Charging Cradle with Power Cord or Battery Charging Cable

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Rechargeable Battery Pack

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Operation Manual

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Bolus cable

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9V Alkaline Battery compartment (optional)

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Disposable Battery Pack (optional)

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External charger (optional)

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Extended life battery Li-Ion Polymer

If any items are missing or damaged, contact your BodyGuard 595 Color Vision™ 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 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.

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