BD BodyGuard 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, and BodyGuard 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™ 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. Pump Rear and Side 3.4. Pump Charger 3.5. Symbols 3.6. Safety Checks 4. Installation and Setup 4.1. Unpacking 4.2. Installing the Drop Sensor (Optional) 4.3. 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. Operation Workflow 5.3. Access Codes 5.4. Loading the Infusion Set 5.5. Turning the Pump On and Off 5.6. Priming the Infusion Set 5.7. Programs 5.7.1. Selecting a Program 5.7.2. Running a Continuous Program 5.7.3. Running a TPN Program 5.7.4. Running an Intermittent Program 5.7.5. Running a PCA Program 5.7.6. Running a 25 Steps Program 5.7.7. Running a Drug Library Program 5.8. Delaying an Infusion 5.9. Keep Vein Open (KVO) Mode 5.10. Viewing Information During an Infusion 5.11. Resetting Volume Infused 5.12. Stopping and Restarting an Infusion BD BodyGuard™ Directions For Use - Rev. 02

5 5 5 5 5 6 6 6 6 7 9 10 10 11 11 12 14 16 17 17 17 18 19 19 19 20 20 21 21 22 22 24 25 25 30 32 36 41 43 45 46 46 46 46 3

5.13. Safety Locks 5.14. End of Infusion 6. Pump Settings 6.1. Viewing Current Pump Settings 6.2. Changing Pressure During an Infusion 6.3. Changing Buzzer Level 6.4. Changing Settings Protected by Access Code 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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47 49 50 50 50 51 51 54 54 55 60 61 61 61 62 62 62 63

BD BodyGuard™ Directions For Use - Rev. 02

1. Introduction

1. Introduction 1.1. Overview The BD BodyGuard™ infusion pump (hereinafter referred to as “pump”) provides the following features: Small, light, and compact pump. Ambulatory pump. l BD BodyGuard™ MicroSet Burette, 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 Rechargeable lithium polymer battery. l Battery charged in a BD BodyGuard™ pump charger or with an AC adapter. l Drop sensor (optional). l RS232 port for data collection. l The pump may be used in road ambulances by paramedics and ambulance emergency medical technician. The pump features six programs: l l

Continuous program: Continuous infusion in rate-over-volume mode or volume-over-time mode. TPN program: Total Parenteral Nutrition program, with programmable up and down times. l Intermittent program: A set dose delivered in set intervals. l PCA program: Patient Control Analgesia program, with continuous delivery and programmed boluses. l 25 Steps program: A sequence of up to 25 delivery steps. l Drug Library program: Continuous program that supports up to 128 drug protocols, with hard and soft limits for added patient safety. 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™ 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, parenteral fluids, biosimilars, chemotherapeutic agents, blood or blood products infusion and general fluids therapy in hospital and home care environments.

1.3. Intended Audience The intended audience of this Directions For Use are clinicians. Homecare patients should refer to the Quick Reference Guide.

1.4. Document History Revision

Date

Software Version

Description

02

September 2023

BGCV_CFN_25xx

Updated flow rates.

01

August 2021

BGCV_CFN_25xx

European Authorized Representative address change.

00

March 2020

BGCV_CFN_25xx

Initial release.

BD BodyGuard™ 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™ 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, such as electrosurgical cauterizing 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 (ref.: 130-050XV). 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™ Directions For Use - Rev. 02

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2. Safety Information

Warning: Before operating the pump, ensure that the infusion bag contains an additional 5 mL of volume, to provide adequate volume for KVO during end of infusion. If the Caregiver Delay setting is enabled, you must include enough volume for the delay period, in addition to the 5 mL KVO volume. 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: Infusion of blood or blood products should be restricted to a maximum rate of 600 mL/hr. Warning: Infusion of Fresh Frozen Plasma (FFP) and platelets should be restricted to a maximum rate of 300 mL/hr. Warning: Refer to the labeling of the infusion set for guidelines on when to replace the infusion set. Warning: Do not place the drop sensor in the lower fluid-filled portion of the drip chamber. Warning: Ensure that the drip chamber is 1/3 full and upright. Warning: Do not use the drop sensor in direct sunlight. Warning: If you remove the pump from the pump charger, the drop sensor does not work. 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: Use of the infusion pump at high infusion rates has an increased risk of under-infusion above the reported accuracy. It is recommended not to use the infusion pump above 800 mL/hr. 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.

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BD BodyGuard™ Directions For Use - Rev. 02

2. Safety Information

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. 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.

BD BodyGuard™ 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

Prime/Bolus key

l l

l

9

10

Up key and Down key

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. During programming: Primes the infusion set. During Continuous program: Delivers bolus or secondary infusion (piggyback). During PCA program: Delivers bolus or secondary infusion (piggyback).

Scrolls up and down through options.

BD BodyGuard™ 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. Pump Rear and Side

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™ 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. 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™ 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.

4

Power socket

Connects the pump charger to the power cord.

BD BodyGuard™ 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 BD BodyGuard™ infusion pump is designed for infusion of medications or fluids. The BD BodyGuard™ infusion 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™ 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.

BD BodyGuard™ Directions For Use - Rev. 02

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3. Pump Description

3.6. Safety Checks Safety checks are designed in order 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.

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 2 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 set is resolved. An occlusion may pressurize the infusion set, 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 25 mL/hr

Occlusion Pressure

Unintended Bolus Volume

100 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 set to neutral within 15 seconds. Neutral line pressure is achieved by the reverse operation of the pumping mechanism, and the pressure of the infusion set is measured by the pressure detection system.

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BD BodyGuard™ 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 charger from the box. 2. Ensure that no items were damaged during shipment. 3. Ensure that you have the following items: l BD BodyGuard™ 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 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. Installing the Drop Sensor (Optional) The drop sensor can raise an alarm if drops falling in the drip chamber of the infusion set are less than a minimum value or more than a maximum value. To install the drop sensor, do as follows: 1. 2. 3. 4. 5.

Secure the pump charger with the pump to an IV pole. . Turn on the pump. Spike the bag with the infusion set. Squeeze the drip chamber and fill it 1/3 full. Attach the drop sensor to the upper unfilled portion of the drip chamber. Warning: Do not place the drop sensor in the lower fluid-filled portion of the drip chamber.

6. Connect the drop sensor to the drop sensor socket. 7. Proceed with loading, priming, and set up instructions. 8. Set minimum drops per milliliter on the Flow Control setting (refer to section 6.4. Changing Settings Protected by Access Code on page 51). Warning: If the minimum value of the Flow Control setting is higher than 0 and no drop sensor is connected to the pump, the low flow alarm is triggered and the infusion is stopped. If you do not need to use the drop sensor anymore, disconnect the drop sensor and set the minimum value of the Flow Control setting to 0. NOTE: The number of drops per milliliter depends on the infusion set. Refer to the labeling of the infusion set.

Figure 4-1. Drop Sensor

Warning: Ensure that the drip chamber is 1/3 full and upright. Warning: Do not use the drop sensor in direct sunlight.

BD BodyGuard™ Directions For Use - Rev. 02

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4. Installation and Setup

Warning: If you remove the pump from the pump charger, the drop sensor does not work.

4.3. 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.

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BD BodyGuard™ Directions For Use - Rev. 02

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 Drip Chamber

Item

Description

1

Spike cap

Keeps the infusion set sterile.

2

Spike

Connects the infusion set to the solution bag.

3

Drip chamber

Displays drops that are infused from the administration bag to the patient.

4

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.

5

Pumping segment

Used by the pumping mechanism to move the solution.

6

Set key

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

7

Slide clamp

Can be used to occlude the tube.

8

Y injection port (optional)

Allows the operator to use a syringe to add drugs directly into the set.

9

BD BodyValve™

Anti-siphon valve, with male Luer lock.

10

Luer lock cap

Keeps the infusion set sterile.

BD BodyGuard™ Directions For Use - Rev. 02

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5. Operation

Example of Infusion Set with 1.2 Micron Filter

Item

Description

1

Spike cap

Keeps the infusion set sterile.

2

Spike

Connects the infusion set to solution bag.

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

5

Set key

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

6

Filter 1.2 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.

Used by the pumping mechanism to move the solution.

NOTE: BD BodyGuard™ MicroSet Burette infusion sets contain a metered burette chamber. To fill the chamber when using these infusion sets ensure that the vent and the clamp located on or above the chamber are in the open position. Avoid squeezing the burette chamber.

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. Operation Workflow The following operation workflows list the general steps for starting the infusion procedure in the following cases: Pump priming: The pump is used to prime the infusion set. Manual priming: The infusion set has a priming valve and needs to be manually primed. Refer to relevant sections for detailed instructions. l l

Warning: Ensure that the infusion set is not connected to the patient during priming. Warning: Verify that infusion programming is complete and that infusion proceeds normally before leaving the pump unattended.

Pump Priming If you use the pump to prime the infusion set, proceed as follows: 1. Connect the infusion set to the medication container. (Optional) Hang the container on an IV pole. 2. Insert the pump into the charger and secure the pump to the charger by using the safety screw. (Optional) Secure the charger to the IV pole by using the screw clamp. 3. Connect the power cord to the charger and to a grounded AC outlet. 4. Open the pump door and load the infusion set into the pumping channel (refer to section 5.4. Loading the Infusion Set on page 21). 5. Turn on the pump (refer to section 5.5. Turning the Pump On and Off on page 22). 6. Prime the infusion set (refer to section 5.6. Priming the Infusion Set on page 22). 7. Start a program (refer to section 5.7.1. Selecting a Program on page 25).

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BD BodyGuard™ Directions For Use - Rev. 02