BodyGuard 323 Epidural Infusion System Directions For Use Rev 00

BodyGuard 323 Color Vision™ Directions For Use

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BodyGuard 323 Color Vision™ Directions For Use

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BodyGuard 323 Color Vision™ Directions For Use

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Table of Contents 1- Introduction ... 7 Overview ... 7 Keypad Description and Functions ... 8 BodyGuard 323 Color Vision™ Pump with Open Door ... 11 Pump Charger ... 11 System Safety Checks ... 13 Pump Accuracy ... 13 2 – Symbols, Warnings, and Cautions ... 17 System Symbols... 17 Terms Used In Manual ... 19 Intended Use ... 19 Warnings ... 19 Cautions ... 21 3 – Installation and Set up ... 22 Unpacking ... 22 Drop Sensor Operation (Optional)……………………………………………………….. 20 Charging the Pump ... 23 4 – Operation ... 25 Dedicated BodyGuard Administration Sets ... 25 The BodyValve™ ... 25 MicroSet™ with Drip Chamber ... 26 MicroSet™ with 1.2mic Filter ... 27 Loading the Administration Set... 27 Priming the Line ... 28 Prime – In Continuous, Intermittent, TPN , and 25 Steps Modes ... 28 Prime – In PCA Mode ... 29 Prime Operation – After Air In Line Alarm ... 30 Manual Prime Operation ... 31 Operation Steps ... 31 Pump Mounted on IV Pole... 31 Portable Connection ... 32 Programming ... 32 Keep Vein Open Mode (KVO) ... 33 End Program ... 33 Changing Current Program – Using Level 1 Code ... 33 Changing Current Program – Short Way... 35 Continuous Infusion... 35 Bolus Infusion During Continuous Operation……...………………………………...…44 Drug Library... 41 Intermittent Infusion ... 47 25 Steps Protocol ... 56 TPN Infusion... 58 PCA Infusion ... 61 Using History Functions ... 72 Events Log ... 73 Setting Pressure Default For Down Occlusion ... 74 BodyGuard 323 Color Vision™ Directions For Use

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Lock Mode ... 75 How To Lock ... 75 Info Mode ... 78 Program Lock ... 81 Review Set up ... 81 Change Set up ... 82 5 – Alarm Conditions and Troubleshooting ... 85 Alarm Condition ... 85 Troubleshooting... 87 6 – Specifications ... 92 7 – Service and Maintenance... 98 Cleaning ... 98 Storage ... 98 Periodic Maintenance ... 98 Battery Operation ... 99 LIMITED WARRANTY ... 102

BodyGuard 323 Color Vision™ Directions For Use

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1 - Introduction

1- Introduction Overview The BodyGuard 323 Color Vision™ system provides the following features:    1.

2.

3.

Small, light, and compact pump. Ambulatory pump Multiple Programs:

Continuous

Drug Library

Intermittent

4.

TPN

5.

6.

PCA

25 Steps

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 (Piggyback) programmable with the same infusion rate and volume capabilities as the primary continuous infusion. Bolus Infusion has a defined default rate in the set up menu, with a variable volume between 0.1-100ml. Continuous program, as above, and can support up to 128 capability capabilities drug protocols. Protocols have hard and soft limits for added patient safety. A set dose delivered in set intervals. Between Intervals the pump will keep vein 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: 0-100ml Clinician Bolus Volume: 0.1-100ml Bolus Rate: 0.1-1200 ml/h 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 6553ml, for each step Accumulated Volume for all steps – up to 10 liters, or in volume over time mode.



Operated with a custom safe administration set



Rechargeable Lithium-Polymer battery



Battery charged in a BodyGuard Color Vision Charger or with an A/C adapter



Free flow protection Anti-Siphon valve standard on every CME administration set



Quiet operation

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Keypad Description and Functions Front of BodyGuard 323 Color Vision™ Infusion Pump

BodyGuard 323 Color Vision™ Directions For Use

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1 0 5 6 7

1 2 3 4

8

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BodyGuard Color Vision 323 Pump Serial Number: V123456 Production Date: 1-Jan-2000

1. Display Screen  

Displays pump and infusion status Displays programming choices and instructions

Software Version BGCV_CFN_07 Protocol Sample

2. STOP/NO/BACK/CANCEL  Stops infusion  Mutes the alarm condition  Pause priming  Clears the displayed value during programming  Navigates to the previous screen during programming 3. START/ OK  Starts infusion  Confirms selection and setting 4. 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 (Piggyback) Infusion or Bolus Infusion according to the default set-up. Pressing Prime/Bolus key during PCA program operation: Enables bolus procedure.

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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.  Unlocks the pump. 7. INFO 

Supplies information about the pump and its programs (see Info Mode chapter).

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 a High Priority alarm state with a flashing red light Yellow Indicator  Indicates a Medium Priority alarm state with a flashing yellow light  Indicates a Low Priority alarm state with a solid yellow light

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BodyGuard 323 Color Vision™ Pump with Open Door

1 2 3 4

7 8 9

5 6

Area

Function

1.

Latch Holder

Holds the door closed when latch is in vertical position.

2.

Flow Direction Arrows

Shows direction of pump operation.

3.

Pressure Sensor

Detects downstream tubing restriction and occlusion. Downstream occlusuion alarm level can be adjusted to suit patient needs.

4.

Set Key

Ensures the correct loading in the pump.

Pressing Plate

Connected to the door by two springs.

6.

Pump Door

Covers the pressing plate.

7.

Anti-Stretch locator

Assists user in the correct loading of the administration set.

8.

Air sensor – Front

Ultrasonic air detector, which is mounted on the front housing.

9.

Air sensor – Door

Mounted on the door.

5.

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BodyGuard 323 Color Vision™ Charger

1

3 4

2

Area

Function

1.

Charger Display

Displays major pump messages and operation values

2.

Release Handle

Push to release the pump from the charger

3.

Charger LED (orange)

Indicates connection to supply mains

4.

Pump Battery LED (red/green)

Indicates battery charge status



NOTE: 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. The plug is the main isolation device for the pump. Do not position the pump in such a way to make it difficult to disconnect from the mains.

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System Safety Checks The following details outline the safety checks designed into the BodyGuard 323 Color Vision™ 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 Color Vision™ 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 pre-programmed threshold, if the cumulative volume of smaller bubbles exceeds 2ml (+/50%) 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.

Post Occlusion Bolus Reduction System (POBRS) The Post Occlusion Bolus Reduction System (POBRS) 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.

Unintended Bolus An unintended bolus is the volume of fluid that can be potentially delivered to the patient once an occlusion blockage in the administration line is resolved. The following table shows the potential unintended bolus volume under the specified conditions. Intermediate Rate 25ml/h

Occlusion Pressure 100mmHg-1500mmHg (maximum)

Unintended Bolus Volume ≤0.5ml

An occlusion may pressurize the infusion tubing, which can result in an unintended bolus of drug when the occlusion is cleared. In order to prevent this potentiall bolus, disconnect the tubing or relieve the excess pressure through a stopcock, if present. The clinician should weigh the relative risks of disconnection with the risks of an unintended bolus of drug.

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 (72° F or 22° 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 BodyGuard 323 Color Vision™ Directions For Use

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representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed according to IEC 60601-2-24 standard.

Trumpet Curves With the BodyGuard 323 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: 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 323 Color Vision™ Directions For Use

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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

BodyGuard 323 Color Vision™ Directions For Use

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2- Symbols, Warnings, and Cautions

2 – Symbols, Warnings, and Cautions System Symbols The following symbols are used on the BodyGuard 323 Color Vision™ infusion system and components. Labels on the system or statements in this Directions For Use (DFU) 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

Warning

Refer to DFU Read the entire DFU before using the pump. Appears on the display after operator presses

to mute the alarm condition. Pump is

not infusing.

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 re-use single-use disposable components. Type CF applied part

Date of Manufacture Battery Serial Number

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2 – Symbols, Warnings and Cautions

Direct current Expiry Date of disposable Alternating current LOT

Lot Number (applicable to administration sets)

STERILE EO Sterilized with Ethylene Oxide (applicable to administration sets) Degree of particle and water ingress protection.

IP33 Definition of code: I = Ingress P = Protection 3 = Protection from solid objects ≥2.5 mm 3 = Protection from spraying water Class II Medical Electrical Equipment providing double insulation for operator and patient safety. Identifies the manufacturer of a product.

Indicates the authorized representative in the European Community.

Indicates the acceptable upper and lower limits of atmospheric pressure (altitude)..

Indicates the acceptable upper and lower limits of relative humidity.

Indicates the temperature limits to which the medical device can be safely exposed.

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

Indicates a medical device that should not be used if the package has been damaged or open.

Indicates the number of drops per milliliter.

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2 – Symbols, Warnings and Cautions

Terms Used In DFU 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 DFU and all warnings completely before operating the BodyGuard 323 Color Vision™ 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 DFU and all cautions completely before operating the BodyGuard 323 Color Vision™ infusion system. NOTE: Indicates that the information that follows is additional important information or a tip that will help you operating the BodyGuard 323 Color Vision™ infusion system.

Intended Use The BodyGuard 323 Color Vision™ 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, intrathecal, 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 fluids, biosimilars, chemotherapeutic agents, blood or blood products infusion, and general fluids therapy in hospital and home care environments.

The BodyGuard 323 Color Vision infusion pump system is a medical device that is intended for use by qualified, trained, medical professionals, patients, or patient caregivers.

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

Read the entire DFU 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. 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 323 Color Vision™ should be operated only with the MicroSet™ IV lines. Use of IV lines other than the 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 manufacturer’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.

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2 – Symbols, Warnings and Cautions

Any adjustments, maintenance, or repair of the pump may impair the operation of the BodyGuard 323 Color Vision™ 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 323 Color Vision™ infusion system should be operated within the recommended environmental operating range. 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.

The plug is the main isolation device for the pump.

No modification to this equipment is allowed. Do not use this equipment with other infusion systems or accessories that are not approved to be used with this pump system. Dropping the BodyGuard 323 Color Vision™ infusion system could cause damage to components. If the pump is dropped, return the pump for inspection by qualified service personnel. Do not operate the pump near high-energy radio-frequency emitting equipment, such as electrosurgical cauterizing equipment, or within 1800 ft of a transmitting television broadcast antenna. False alarm signals may occur. Do not let the pump operate when battery is fully depleted. Pump may turn off during operation on fully depleted battery. Before beginning infusion, ensure that the pump battery is fully charged. Prior to first use, technical service personnel shall verify functionality of pump per the Technical Service Manual.

Pump should be stored with the battery connected, otherwise the internal rechargeable battery may lose track of actual time. Do not use the BodyGuard Infusion Pump in close proximity to high energy medical equipment (e.g., Imaging equipment (i.e., X-Ray, MRI, CT Scan, etc.), High Frequency (RF) Surgical Equipment, Defibrillator, etc.) as this may cause degradation in performance of the Infusion Pump, which may affect proper infusate delivery. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BodyGuard Infusion Pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Lithium Metal Batteries – Forbidden for transport aboard passenger aircraft.

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