BD BodyGuard Pain Manager Infusion System Directions For Use Rev 02

Caesarea Medical Electronics Ltd. 16 Shacham Street Industrial Park Caesarea North P.O.BOX 3009 Caesarea 3088900, Israel

Becton Dickinson Ireland Ltd. Donore Road, Drogheda, Co. Louth, A92 YW26, Ireland

BD.com The information in this document is subject to change and does not represent a commitment on the part of Caesarea Medical Electronics Ltd. to provide additional services or enhancements. The screens illustrated in the document are for reference purposes only and might be different than the screens displayed on your pump. Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area. BD, the BD logo, BodyGuard, BodyValve, and MediGuard are trademarks of Becton, Dickinson and Company or its affiliates. NRFit is a trademark of GEDSA used with their permission. ©2023 BD. All rights reserved.

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BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

Table of Contents 1. Introduction 1.1. Overview 1.2. Intended Use 1.3. Intended Audience 1.4. Document History 2. Safety Information 2.1. Safety and Advisory Terms 2.2. General Warnings 2.3. Operation Warnings 2.4. Infusion Warnings 2.5. Cautions 3. Pump Description 3.1. Pump Keypad 3.2. Pumping Channel 3.3. Rear and Side of Pump 3.4. Pump Charger 3.5. Symbols 3.6. Safety Checks 4. Installation and Setup 4.1. Unpacking 4.2. Charging the Pump 5. Operation 5.1. Infusion Sets 5.1.1. Common Types of Infusion Sets 5.1.2. BD BodyValve™ Anti-Siphon Valve 5.2. Access Codes 5.3. Turning On and Off the Pump 5.4. Infusion Protocols 5.4.1. Setting Up an Infusion Protocol 5.4.2. Bolus Options 5.4.3. Setting Up a Bolus 5.5. Operation Workflow 5.6. Loading the Infusion Set 5.7. Priming the Infusion Set 5.8. Programming an Infusion 5.9. Programming a Bolus 5.10. Setting Automatic Drug Limits (BD MediGuard™ Option) 5.11. Keep Vein Open (KVO) Mode 5.12. Viewing Information During an Infusion 5.13. Changing Rate During an Infusion 5.14. Resetting Volume Infused and Shift Totals 5.15. Stopping and Restarting an Infusion 5.16. Changing the Infusion Container 5.17. Keypad Lock BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

5 5 5 5 5 6 6 6 6 7 8 10 10 11 11 12 14 15 17 17 17 18 18 18 19 19 19 19 20 24 24 28 29 30 31 33 35 36 36 36 36 36 36 37 3

5.18. End of Infusion 6. Pump Settings 6.1. Changing Pump Settings 6.2. Viewing Current Pump Settings and Patient History 7. Troubleshooting 7.1. Alarms 7.2. Troubleshooting Instructions 7.3. Event Log 8. Service and Maintenance 8.1. Periodic Maintenance 8.2. Cleaning 8.3. Battery 8.4. Storage 8.5. Disposal and Decommissioning 9. Specifications

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38 39 39 40 41 41 42 45 46 46 46 47 47 47 48

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

1. Introduction

1. Introduction 1.1. Overview The BD BodyGuard™ Pain Manager infusion pump (hereinafter referred to as “pump”) provides the following features: Small, light, and compact pump. Ambulatory pump. l BD BodyGuard™ MicroSet and BD BodyGuard™ MicroSet NRFit™ infusion sets (hereinafter referred to as “BD BodyGuard™ infusion sets”), with anti-siphon valve for free-flow protection. l Post Occlusion Bolus Reduction System (POBRS), to reduce bolus after a downstream occlusion. l Prevents false occlusion alarms when delivering boluses through an epidural or PCA catheter by automatically adjusting the bolus delivery rate. l Uses color coding system on infusion sets and on the display screen of the pump to enhance safety. l BD MediGuard™ protection helps ensure that drug protocols are suitable with patient weight. l Rechargeable lithium polymer battery. l Battery charged in a BD BodyGuard™ pump charger or with an AC adapter. l RS232 port for data collection. l The pump may be used in road ambulances by paramedics and ambulance emergency medical technician. The pump has multiple delivery methods: l l

Basal only Basal and bolus l Bolus only The pump has multiple bolus types: l l

Patient bolus Auto bolus l Patient bolus combined with auto bolus The pump has the following infusion modes: l l

PCA Epidural l Regional Therapy should always be overseen by a physician or a certified, licensed healthcare professional. As appropriate, the patient should be instructed in using the pump. l l

1.2. Intended Use The BD BodyGuard™ Pain Manager infusion pump 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 in hospital and home care environments. The BD BodyGuard™ Pain Manager infusion pump is designed for patients who require epidural, regional or PCA pain management. The BD BodyGuard™ Pain Manager infusion pump is for use by, or under the supervision of trained medical staff in the hospital and the home care environments.

1.3. Intended Audience The intended audience of this Directions For Use are clinicians.

1.4. Document History Revision

Date

Software Version

Description

02

September 2023

BGCV595_061xx

Updated flow rates.

01

August 2021

BGCV595_061xx

European Authorized Representative address change.

00

June 2020

BGCV595_061xx

Initial release.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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2. Safety Information

2. Safety Information 2.1. Safety and Advisory Terms 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. Caution: Indicates that the information is a caution. Cautions advise you of circumstances that could result in damage to the device. NOTE: Indicates that the information is additional important information or a tip that helps you operate the pump.

2.2. General Warnings Warning: Read the entire Directions For Use before using the pump, since the text includes important precautions, and keep the Directions For Use for future reference. Warning: Home users of the pump should be instructed by a trained home healthcare provider or clinician on the proper use of the pump. Warning: No modification to this equipment is allowed. Warning: When the pump is in the pump charger, the plug of the pump charger is the main isolation device for the pump. Switching off the pump does not disconnect the pump from AC power. To disconnect the pump from AC power, remove the power cord from the AC power outlet or remove the pump from the pump charger. Warning: The system may include small parts that can pose a potential choking hazard. Warning: Always use the appropriate length of infusion set tubing and arrange system cables to minimize the risk of potential strangulation. Warning: Potential allergic reactions may occur due to materials used in the pump.

2.3. Operation Warnings Warning: Prior to first use, technical service personnel should verify functionality of the pump per the Technical Service Manual. Warning: Do not open the pump enclosure. Voltage present on internal components may cause severe shock or death upon contact while pump and pump charger are connected to AC power. Only a BD certified technician should open the pump enclosure. Warning: The pump is not certified for use in oxygen-enriched environments. Warning: When the pump is charging, ensure that the pump is firmly attached to the pump charger. Warning: If you use an IV pole, ensure that the pump and the pump charger are firmly attached to the IV pole. Warning: Any adjustments, maintenance, or repair of the uncovered pump may impair the operation of the pump and/or the accuracy of infusion. Any adjustments, maintenance, or repair of the uncovered pump should be performed by a BD certified technician. Any adjustments, maintenance, or repair of the uncovered pump while connected to AC power should be avoided. Warning: The pump should be operated within the recommended environmental operating range. Operating the pump at temperatures and/or humidity outside that range may affect accuracy. Warning: Use of improper accessories represents unsafe operation. Use only accessories and options designed for this pump. 6

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

2. Safety Information

Warning: Do not use the pump with infusion systems or accessories that are not approved to be used with the pump. Warning: Do not operate the pump near high-energy radio-frequency emitting equipment or within 1800 ft (549 m) of a transmitting television broadcast antenna. False alarm signals may occur. Warning: Do not use the pump in close proximity to high-energy medical equipment (for example, imaging equipment (like X-Ray, MRI, CT Scan, etc.), high-frequency (RF) surgical equipment, defibrillator, etc.) as this may cause degradation in performance of the pump, which may affect proper infusate delivery. Warning: 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. Warning: 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. Warning: 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 pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Warning: When operating the pump at elevated temperatures, up to 45°C (like you could experience while outside on a hot day or in an automobile), the push buttons on the front panel become hot to the touch (55.5°C). Warning: If the battery is damaged during operation, while the charger is disconnected from AC power, the pump turns off. Warning: Do not operate the pump on AC power if the battery is not loaded in the pump for back up. Warning: Do not store the pump with the battery fully depleted. Warning: Replace the battery only with BD supplied battery. Warning: Turn off the pump and disconnect the power cord from the AC power outlet before cleaning. Warning: When fluid ingress is suspected, stop using the pump and request pump verification through maintenance to identify potential need of corrections. Warning: In the home healthcare environment, children, pets, fireplaces, dust, lint, direct sunlight all may affect the pump operation.

2.4. Infusion Warnings Warning: Do not use the pump when the battery is fully depleted. The pump may turn off during operation if the battery is fully depleted. Before beginning an infusion, ensure that the battery is fully charged. Warning: The maximum volume that may be infused under single fault condition is 0.1 mL. Warning: Do not operate the pump with any infusion set other than the BD BodyGuard™ infusion sets. BD BodyGuard™ infusion sets are equipped with an anti-siphon valve to prevent a gravitational free-flow hazard. Using a different infusion set may essentially change the administration rate and expose the patient to free flow, which can cause serious injury or even death. Warning: Injury may occur to patient or operator if the infusion set packaging is received at point of use unsealed, or damaged, or if damaged components are used. Warning: If the infusion set is damaged the product may no longer be sterile. Visually inspect contents and package before each use. Warning: To use the automatic KVO at the end of a protocol, ensure that the infusion container contains an additional dose over the volume to be infused.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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2. Safety Information

Warning: Ensure that the infusion set is not connected to the patient during priming. Warning: A kinked or occluded infusion set may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the infusion set is not kinked or occluded. Warning: Verify that infusion programming is complete and that infusion proceeds normally before leaving the pump unattended. Warning: 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. Warning: Infusion sets must be compatible with the medicine delivered. Refer to drug manufacture guidelines. Warning: Refer to the labeling of the infusion set for guidelines on when to replace the infusion set. Warning: Do not attempt to access code protected areas if you are not trained or authorised to do so. Authorised personnel must not share access codes with unauthorised personnel and must only give access codes to designated personnel. Warning: Do not set alarm limits to extreme values. This may render the alarm system useless. Warning: A potential hazard may exist if different alarm presets are used for the same or similar equipment in any single area. Warning: The operator must ensure that current alarm presets are appropriate prior to use on each patient. Warning: The infusion rate for bolus administrations is set to a maximum bolus rate of 300 mL/hr as there is an increased risk of severe under-infusion. The use above 300 mL/hr is not recommended.

2.5. Cautions Caution: Dropping the pump could cause damage to components. If the pump is dropped, return the pump for inspection by a BD certified technician. Caution: Leaving the battery fully depleted for a long period of time may damage the battery. Caution: Immersing the pump into liquid could cause damage to components. Do not soak or immerse any part of the pump or the pump charger into any type of liquid. Caution: If other chemical cleaning agents are used for the "disinfection protocol / regime", ensure to follow the manufacturer recommended cleaning to preserve pump performance, after completing the "disinfection protocol / regime". Caution: Do not spray or rinse cleaning solutions directly on pump surfaces or in potential liquid retention areas or open ports such as electrical connections. Caution: Avoid using chemicals that can damage the surfaces of the instrument (for example, chlorinated solvents). Caution: When using cleaning solutions containing chemicals (such as corrosive agents), do not use concentrated solutions and do not expose surfaces above the recommended dwell time. After application, rinse surfaces with IPA disposable wipes to eliminate chemical residue. Caution: Do not steam, autoclave, EtO (ethylene oxide) sterilize, immerse the pump or the pump charger in any type of fluids, or allow fluids to enter the pump case. Caution: Battery damage could occur if the pump is left in a temperature higher than 50°C (122°F). Caution: Do not position the pump in a way that makes it difficult to unplug the pump charger. Caution: The set key (black) of the infusion set can only be fitted into the keyway one way. If you have trouble in fitting the set key, do not force, remove the set key and verify flow direction. 8

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

2. Safety Information

Caution: Component damage may occur if the infusion set is not installed properly. Ensure that all connections are secure and do not over tighten. This will help minimize leaks, disconnection, and component damage. Caution: The bolus cable may be damaged if it is not installed or secured properly. Ensure that all connections are secure to help minimize disconnection and component damage. If the bolus cable is damaged, return the bolus cable for inspection by a BD certified technician.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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3. Pump Description

3. Pump Description 3.1. Pump Keypad

1

Icon

Name

Description

N/A

LED indicators

l

l l l

2

N/A

Display screen

l l

Solid yellow: Low-priority alarm or the pump is in stand-by mode. Flashing yellow: Medium-priority alarm. Flashing red: High-priority alarm. Flashing green: Infusion is in progress. Displays pump and infusion status. Displays programming choices and instructions.

3

ON/OFF key

Turns on and turns off the pump.

4

Lock key

Locks/unlocks the pump.

5

Info key

Supplies information about the pump and programs.

6

Stop/No/Back/Cancel key

l l l l l l

7

Start/OK key

l l

8

Bolus key

l l

Stops infusion. Mutes alarms. Pauses priming. Clears the displayed value during programming. Erases the last digit during programming. Navigates to the previous screen during programming. Starts infusion. Confirms selection and setting. Programs auto-bolus and clinician activated bolus. Changes bolus settings (lockout time and bolus rate) during an infusion.

9

Left key and Right key

Scroll left and right to select characters.

10

Up key and Down key

l l

10

Scroll through options. Scroll up and down to select characters.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

3. Pump Description

3.2. Pumping Channel

Item

Description

1

Air sensor

Ultrasonic air detector (mounted on the front housing).

2

Air sensor

Ultrasonic air detector (mounted on the door).

3

Latch holder

Blocks/unblocks the door.

4

Flow arrows

Show direction of infusion.

5

Door

Pump door. Image shows the door open.

6

Pumping mechanism

Moves the fluid along the infusion set.

7

Pressure sensor

Detects downstream restriction and occlusion in tubing.

3.3. Rear and Side of Pump

Item

Description

1

Battery

Pump battery.

2

Unlock clip

Releases the battery from the pump.

3

Wall charger socket

Connects the pump to the external wall charger.

4

Bolus cable socket

Connects the pump to a bolus cable.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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3. Pump Description

3.4. Pump Charger Front View

Item

Description

1

Charger display

Displays data from the pump.

2

AC power LED

Orange: The pump charger is connected to AC power.

3

Battery LED

The battery LED is lit when the pump is in the pump charger and the pump charger is connected to AC power: l Red: The battery is charging. l Green: The battery is fully charged.

4

Mounting instructions

Visual instructions on how to secure the pump to the pump charger.

5

Release handle

Releases the pump from the pump charger.

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BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

3. Pump Description

Rear View

Item

Description

1

RS232 port

Connects the pump to a PC.

2

Screw clamp

Secures the pump charger to a pole.

3

Drop sensor socket

Connects the pump to a drop sensor. NOTE: Drop sensor is not active.

4

Power socket

Connects the pump charger to the power cord.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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3. Pump Description

3.5. Symbols Symbols on Both Pump and Infusion Sets Symbol

Description CE mark indicates conformance to the Medical Device Directive 93/42/EEC. The numeric code identifies the certification authority. Manufacturer. Date of manufacture. Authorized representative in the European Community. Manufacturer’s catalogue number.

Symbols on Pump Only The pump is designed for infusion of medications or fluids. The pump is a reusable, serviceable medical device, intended to receive annual maintenance to preserve system accuracy. Symbol

Description Read Directions For Use for important cautionary information that cannot be presented on the pump. Read the entire Directions For Use before using the pump. Appears on the display screen after operator presses infusing.

to mute the alarm condition. Pump is not

Do not dispose of in municipal waste. Symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2012/19/EU). NOTE: Does not apply to the battery. Do not dispose of battery in municipal waste. Symbol indicates separate collection for battery is required. Type CF applied part (IEC 60601-1). Applied part is suitable for direct cardiac application.

Class II Medical Electrical Equipment (IEC 61140). The pump provides double insulation for operator and patient safety. Serial Number. Battery. Direct current. Alternating current. Degree of particle and water ingress protection. Protection from solid objects ≥ 2.5 mm and from spraying water. Indicates the temperature limits to which the medical device can be safely exposed.

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BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

3. Pump Description

Symbol

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

Indicates the acceptable upper and lower limits of relative humidity.

Symbols on Infusion Sets Only The BD BodyGuard™ infusion sets are designed for infusion of medications or fluids. The BD BodyGuard™ infusion sets are single use infusion sets and are not reusable. Symbol

Description Read the instruction for use for important cautionary information that cannot be presented on the infusion set. Read the instructions for use before using the infusion set. Do not reuse single-use disposable components.

Do not use the product if the package has been damaged or opened.

Sterilized with ethylene oxide. Lot number. Expiry date of disposable. Indicates the upper temperature limit to which the infusion set can be safely exposed.

The fluid path is non-pyrogenic.

Indicates infusion sets for single use with pressure infusion apparatus.

Indicates the number of drops per milliliter.

3.6. Safety Checks Safety checks are designed to help minimize the possibility of under- or overinfusions.

Free-Flow Protection BD BodyGuard™ infusion sets are equipped with an anti-siphon valve that prevents free-flow towards the patient when the infusion set is not attached to the pump. When the pump is attached to the infusion set and fluid is delivered, the pressure delivered by the pump opens the anti-siphon valve. The anti-siphon valve is a one-way valve that also prevents fluid from flowing from the patient to the infusion set.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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3. Pump Description

Air-in-Line Accumulation To improve the detection of air in the infusion set, the pump detects air-in-line accumulation in addition to the standard single-bubble detection. The air-in-line accumulation feature monitors the volume of air that passes through the infusion set by accumulating the volume of individual bubbles over any 15 minutes period. Although a single bubble may not exceed the preprogrammed threshold, if the cumulative volume of smaller bubbles exceeds 1 mL over a period of 15 minutes, an air-in-line alarm is initiated. The accumulation feature is particularly useful with infusions for patients who are highly sensitive to air (like infants, neonates, children) or with products that create significant volumes of small air bubbles.

Unintended Bolus An unintended bolus is the volume of fluid that can be potentially delivered to the patient once an occlusion blockage in the infusion line is resolved. An occlusion may pressurize the infusion line, which can result in an unintended bolus of drug when the occlusion is cleared. The following table shows the potential volume of an unintended bolus under specified conditions. Intermediate Rate

Occlusion Pressure

Unintended Bolus Volume

25 mL/hr

250 mmHg to 1500 mmHg

≤ 0.5 mL

In order to prevent this potential bolus, disconnect the infusion set 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.

Post Occlusion Bolus Reduction System (POBRS) The Post Occlusion Bolus Reduction System (POBRS) is designed to reduce the bolus that may occur when an occlusion is released after a downstream occlusion alarm. When a downstream occlusion is detected, the alarm is activated and the pump returns the pressure on the infusion line to neutral within 15 seconds. Neutral line pressure is achieved by the reverse operation of the pumping mechanism, and the pressure of the infusion line is measured by the pressure detection system.

Program Limits (Including BD MediGuard™ Toxicity Settings) Users can choose from a number of options to limit protocol parameters and set safe ceilings on drugs infused (refer to section 6.1. Changing Pump Settings on page 39). When the BD MediGuard™ feature (Program Limits setting) is enabled, 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 BD MediGuard™ limit, the pump alerts the user 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 clinical staff with level-three authorization. You can choose to limit the bolus volume over either a 1, 4, or 24 hour period according to local practice. The level-three access code is required to change the protocol or ceiling.

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BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

4. Installation and Setup

4. Installation and Setup 4.1. Unpacking To unpack the pump, do as follows: 1. Carefully remove the pump and the pump charger from the box. 2. Ensure that no items were damaged during shipment. 3. Ensure that you have the following items: l BD BodyGuard™ Pain Manager infusion pump l Pump charger with power cord (cable length: 2.5 m) l Rechargeable Battery Pack Lithium Polymer 1800 mAh l Directions For Use (this manual) l Quick Reference Guide l PCA bolus cable (cable length: 2.0 meters) NOTE: If any items are missing or damaged, contact your supplier. NOTE: In certain locales, power cord may come as a separate item.

4.2. Charging the Pump To charge the pump, do as follows: 1. Connect the pump charger to AC power and verify that the AC power LED is lit. 2. Put the pump into the pump charger (top first) until the pump clicks into place.

3. The battery is charging when the battery LED is red. The battery is fully charged when the battery LED turns green. If the LED does not light or does not turn green after more than 8 hours, replace the battery. 4. Remove the pump from the charger by pressing the release handle and lift the pump out of the charger bottom first.

Warning: If the battery is damaged during operation, while the charger is disconnected from AC power, the pump turns off. Caution: Leaving the battery fully depleted for a long period of time may damage the battery. NOTE: The pump is protected against overcharging. Connect the pump to AC power via the charger whenever possible to be sure that the battery is fully charged at all times.

BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

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5. Operation

5. Operation 5.1. Infusion Sets The pump must only be operated only with the BD BodyGuard™ infusion sets. Warning: Do not operate the pump with any infusion set other than the BD BodyGuard™ infusion sets. BD BodyGuard™ infusion sets are equipped with an anti-siphon valve to prevent a gravitational free-flow hazard. Using a different infusion set may essentially change the administration rate and expose the patient to free flow, which can cause serious injury or even death. Warning: Refer to the labeling of the infusion set for guidelines on when to replace the infusion set. Warning: 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.

5.1.1. Common Types of Infusion Sets Example of Infusion Set with 0.2 Micron Filter

Item

Description

1

Spike cap

Keeps the infusion set sterile.

2

Spike

Connects the infusion set to solution container.

3

Anti-stretch locator Prevents incorrect tube stretching and locates the infusion set correctly. Color: blue. NOTE: Some infusion sets are not equipped with the anti-stretch locator.

4

Pumping segment

Used by the pumping mechanism to move the solution.

5

Set key

Locates the tube in the correct flow direction. Color: black.

6

Filter 0.2 micron

Filters the fluid path from air and particles.

7

Slide clamp

Can be used to occlude the tube.

8

BD BodyValve™

Anti-siphon valve, with male Luer lock.

9

Luer lock cap

Keeps the infusion set sterile.

Example of Infusion Set with Y Port and Back Check Valve

Item

Description

1

Luer lock cap

Keeps the infusion set sterile.

2

Check valve

One-way valve. Prevents backflow of medication.

3

Slide clamp

Can be used to occlude the tube.

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BD BodyGuard™ Pain Manager Directions For Use - Rev. 02

5. Operation

Item

Description

4

Spike cap

Keeps the infusion set sterile.

5

Spike

Connects the infusion set to solution container.

6

Anti-stretch locator

Prevents incorrect tube stretching and locates the infusion set correctly. Color: blue. NOTE: Some infusion sets are not equipped with the anti-stretch locator.

7

Pumping segment

Used by the pumping mechanism to move the solution.

8

Set key

Locates the tube in the correct flow direction. Color: black.

9

Slide clamp

Can be used to occlude the tube.

10

BD BodyValve™

Anti-siphon valve, inline.

11

Y port

Connects primary infusion set or flush solution.

12

Rotating Luer lock connector

Luer lock male connector.

5.1.2. BD BodyValve™ Anti-Siphon Valve The BD BodyValve™ anti-siphon valve enhances safety by the following features: l l

l l

Prevents free flow in the event that the infusion set is detached from the pump. Prevents back-flow (reflux) in the event that several infusion pumps are connected simultaneously to the same patient. Prevents free flow in the event of a mechanical malfunction. Prevents reflux of blood into the infusion set.

5.2. Access Codes To operate, program, and configure the pump, three access codes are required. Level-one code: Required to run the pump. Default code: 700. Level-two code: Required to deliver a clinician bolus. Code is only provided to authorized personnel. l Level-three code: Required to set up and modify infusion protocols and to change pump settings. Code is only provided to authorized personnel. Additionally, a technician code is required to access the technician menu. The technician code is only provided to fully trained and authorized service personnel. l l

Warning: Do not attempt to access code protected areas if you are not trained or authorised to do so. Authorised personnel must not share access codes with unauthorised personnel and must only give access codes to designated personnel. NOTE: Access codes are only provided to designated and authored clinical or technical staff when they are trained and certified in their use.

5.3. Turning On and Off the Pump To turn on the pump, do as follows: 1. Press and hold the button. 2. Enter the level-one code, then press the To turn off the pump, do as follows: l

Press and hold the

key.

button.

5.4. Infusion Protocols Infusion protocols allow your facility to establish protocols for your most common pain management treatments. The pump supports 26 unique infusion protocols. Each infusion protocol may contain the following settings, which may be a required or optional: l l l l

Infusion Mode (PCA, Epidural, Regional). Drug/protocol name. Minimum and maximum patient weight. Volume to be infused.

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5. Operation

Initial rate in mL or mg or mcg per hour. Initial rate and protocol maximum rate are superseded by the values set in the Change Set up menu. If the BD MediGuard™ option is enabled, rate can only be entered based on body weight units. l Protocol maximum rate. l Bolus dose and maximum bolus dose (if required). l Lockout time between boluses and maximum lockout time (if required). l Maximum clinician (CA) bolus. l Bolus rate. l Applicable hour limit (if required). l Maximum BD MediGuard™ rate (if the BD MediGuard™ option is enabled). l Keep Vein Open (KVO) rate (if required). l Occlusion pressure. l Air-in-line limit. By establishing infusion protocols, for example, your facility may use the following settings for a PCA treatment: morphine 1 mg/1 mL, container volume 100 mL, basal rates 1 mg/hr. In another PCA treatment, some protocol settings may be different, for example patient bolus volumes, lockout time intervals, or container volume. l

Your facility can create up to 26 infusion protocols. Once infusion protocols are set, your facility can allow approved and authorized clinician users to change the settings if a protocol does not meet the patient needs. An access code is required to change settings. NOTE: Infusion protocols support preset values for your most common medication treatments when administering PCA, Epidural, or Regional pain management. To add and maintain protocols, contact your local BD authorized representative for assistance.

5.4.1. Setting Up an Infusion Protocol To set up an infusion protocol, the level-three code is required (refer to 5.2. Access Codes on page 19). Do as follows: 1. Turn on the pump. 2. Press the key to select Modify Protocol Library, then press the

key.

3. Enter the level-three code, then press the key. 4. Press the key or the key to select the type of infusion mode (PCA, Epidural, Regional), then press the key. When you select the type of infusion mode and begin to build the protocol, take into account that the next protocol you build will be restricted based on the infusion mode previously selected, according to the following rules: l If you create a PCA infusion protocol, the next protocol can be a PCA, Epidural, or regional protocol. l If you create an Epidural infusion protocol, the next protocol can be an Epidural or regional protocol. l If you create a regional infusion protocol, the next protocol can be a regional protocol only. The 26 blank infusion protocols are listed in the pump as letters A-Z. The first set of letters will support 10 PCA protocols (A-J). Next set of letters will support 8 epidural protocols (K - R). Next set of letters will support 8 regional protocols (S-Z).

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BD BodyGuard™ Pain Manager Directions For Use - Rev. 02