BD BodyGuard T Directions for Use Rev 04

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, CME, Plastipak and T34 are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. © 2021 BD. All rights reserved.

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BD BodyGuard™ T Directions For Use - Rev. 04

Table of Contents 1. General Information 1.1. About This Directions For Use 1.2. Overview 1.3. Intended Use 1.4. Contraindications 1.5. Document History 2. Safety Information 2.1. Safety and Advisory Terms 2.2. Operation Precautions and Warnings 2.3. Infusion Precautions and Warnings 2.4. General Precautions and Warnings 3. Pump Description 3.1. Syringe Fitting 3.2. Pump Keypad 3.3. Rear of the Pump 3.4. Symbols 3.5. Post Occlusion Bolus Reduction System (POBRS) 4. Installation and Setup 4.1. Pump Inspection and Unpacking 4.2. Battery Power Supply 4.3. Accessories (Optional) 5. Operation 5.1. Disposables 5.1.1. Syringes 5.1.2. Syringe Extension Sets 5.2. Setting Up the Mode of Operation 5.3. Configurable Settings for Modes of Operation 5.4. Operation Workflow 5.4.1. Preparing the Syringe and Manually Priming the Syringe Extension Set 5.4.2. Checking the Syringe Pump 5.4.3. Turning on the Pump and Performing Pre-Loading 5.4.4. Checking the Battery Level 5.4.5. Loading the Syringe 5.4.6. Programming the Infusion 5.5. Purging the System 5.6. Titrating the Rate 5.7. Monitoring and Managing Infusions 5.7.1. Positioning the Pump 5.7.2. Monitoring the Infusion 5.7.3. Checking the Battery Level 5.7.4. Checking the Volume History During Infusion 5.8. Locking the Keypad 5.9. Program Protection and Resume 5.9.1. Resume and New Syringe Options BD BodyGuard™ T Directions For Use - Rev. 04

5 5 5 5 6 6 7 7 7 8 8 9 9 10 11 11 12 14 14 14 16 18 18 18 19 20 21 21 22 22 22 23 23 25 27 27 28 28 28 28 29 29 30 30 3

5.10. Stopping/Pausing the Infusion and Powering Off 5.11. Delivering a Bolus 5.12. Operation Checklists 5.12.1. Checklist for Changing a Syringe (New Program, Same Set) 5.12.2. Checklist for Discontinuing the Infusion and Pump 6. Pump Settings 6.1. Configuration Authorization 6.2. Access Codes 6.3. Changing Pump Settings 6.4. Changing Rate Setting 7. Troubleshooting 7.1. Alarms 7.2. Screen Prompts 7.3. Troubleshooting Instructions 7.4. Releasing a Trapped Foreign Object From the Actuator 7.5. Event Log 8. Service and Maintenance 8.1. Periodic Maintenance 8.2. Cleaning 8.2.1. Pump Cleaning - MRC Protocol 8.2.2. Accessories Cleaning 8.3. Pump Storage 8.4. Disposal and Decommissioning 9. Specifications

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31 31 32 32 32 33 33 33 33 34 36 36 37 37 38 39 40 40 40 40 41 41 42 43

BD BodyGuard™ T Directions For Use - Rev. 04

1. General Information

1. General Information 1.1. About This Directions For Use This Directions For Use provides information about the use of the BD BodyGuard™ T Syringe Pump (hereinafter referred to as 'pump'). The instructions are applicable both to the BD BodyGuard™ T Syringe Pump (REF: 999-103BDXX) and to the T34™ Syringe Pump (REF: 999-103XX) 3rd edition with updated software version (refer to section 1.5. Document History on page 6). Operators must be thoroughly familiar with the operation of infusion pumps. Safe use of the infusion pump can only be achieved if the infusion pump is operated in accordance with the Directions For Use. All illustrations used in this Directions For Use show typical settings and values that may be used in setting up the functions of the syringe pump. These settings and values are for illustrative use only. The complete range of settings and values are listed in the specifications section of this Directions For Use. This Directions For Use has been developed with consideration to the requirements in relevant Harmonised Standards. Data presented in the technical specifications reflect specific test conditions defined in this standard. Other external factors such as varying back pressure, temperature, head height, syringe extension set usage, fluid restrictions, solution viscosity or combinations of these factors, may result in deviations from the performance data enclosed. NOTE: Keep this Directions For Use for future reference during the syringe pump's operational life.

1.2. Overview The pump provides the following features: Compatible with a range of commonly used syringe brands and sizes. Three-point syringe detection system. l Capable of small ml/h rate delivery. l Configurable occlusion pressure. l LCD display screen with backlight. l Green LED indicator to indicate if infusion is in progress. l Event log. The pump's program can operate in two modes: l l

Duration mode: The pump delivers the content of the syringe over a duration. The pump automatically calculates the infusion rate. l Rate mode: The pump delivers the content of the syringe by rate. The pump automatically calculates the duration of the infusion. The following safety features are available: l

l l l l l l

Program lock. Keypad lock. Access codes to protect pump configuration. Post Occlusion Bolus Reduction System (POBRS). Comprehensive range of alerts and alarms. Lockable lockbox (optional).

1.3. Intended Use The T34™ / BD BodyGuard™ T Syringe Pump is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, 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, immunoglobulins, biosimilar, chemotherapeutic agents and general fluids therapy in hospital and homecare environments.

BD BodyGuard™ T Directions For Use - Rev. 04

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1. General Information

1.4. Contraindications The following contraindications apply: l l l l

Infusion of blood and blood products. Infusion of insulin. Infusion of critical medications whose stoppage or interruption could cause serious injury or death. Use in ambulatory regimens by patients who do not possess the mental, physical or emotional capability to selfadminister their therapy, or who are not under the care of a responsible individual.

1.5. Document History Revision

Date

Software Version

Description

04

August 2021

T3.2A-XX

European Authorized Representative address change.

03

January 2021

T3.2A-XX

Updates to warnings (refer to section 2.4. General Precautions and Warnings on page 8).

02

January 2021

T3.2A-XX

Date and time must be checked before first use of the pump and after storage (see sections 4.1. Pump Inspection and Unpacking on page 14 and 8.3. Pump Storage on page 41).

01

November 2020

T3.2A-XX

l

l

l

00

6

November 2020

T3.2A-XX

Updates to section 4.2. Battery Power Supply on page 14: added DURACELL® Plus to list of tested battery; added warning. Added backup alarms to alarms list, see section 7.1. Alarms on page 36. Minor rewording.

Initial release, including T34™ Syringe Pump (REF: 999-103XX) 3rd edition with updated software version.

BD BodyGuard™ T Directions For Use - Rev. 04

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. Operation Precautions and Warnings Warning: Read the entire Directions For Use before using the pump, since the text includes important precautions. Warning: Do not attempt to modify this equipment. Only BD certified technicians are approved to safely carry out maintenance, service or repair of this device. Contact your service representative for assistance. Warning: A kinked or occluded syringe extension set may impair the operation of the pump and the accuracy of the infusion. Before operation, verify that the syringe extension set is not kinked or occluded. Warning: Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the pump distributor. Warning: Do not let the syringe pump operate when battery is fully depleted. Pump may turn off during operation on fully depleted battery. Warning: Before beginning infusion, confirm the battery level is sufficient to complete delivery of the full infusion (see Expected Battery Life table, section 4.2. Battery Power Supply on page 14). Warning: 9V batteries may have a sudden drop in voltage, causing the infusion pump to stop abruptly. If the battery voltage drops below the operational threshold, the pump will shut down and the Backup Buzzer will sound for at least 3 minutes. In the event of a sudden pump shutdown, contact your Clinician, Biomed or BD Representative. 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: Although the pump has been designed and manufactured to exact specifications, it is not intended to replace trained personnel in the supervision of infusions. Warning: The specified accuracy of the syringe pump can only be maintained if the syringe pump is used in accordance with the Directions For Use and is maintained and serviced by a BD certified technician. Warning: Adjustments, maintenance, or repair made by un-certified service personnel may impair the operation of the syringe pump and/or the accuracy of the infusion. Make sure any adjustments, maintenance, or repair of the syringe pump are carried out only by a BD certified technician. Warning: Refer all service, repair and adjustments only to BD certified technicians. Unauthorised modifications or the use of any spare parts, other than those supplied by the manufacturer or their distributor, will void any warranty. Warning: If the syringe pump is subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by a BD certified technician.

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2. Safety Information

Warning: The pump has been designed to be as safe as possible to handle; however, care should be exercised to avoid trapping of fingers or other body parts in the mechanism. 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. Caution: This pump is designed to withstand everyday handling. If the pump is dropped onto a hard surface, or is suspected of being dropped, the operation and calibration should be checked by a BD certified technician. Caution: If the pump will be stored for longer than 60 days, remove the battery to prevent corrosion and decay.

2.3. Infusion Precautions and Warnings Warning: Carefully read and follow accompanying syringe extension set instructions for priming the set and the recommended set change interval. Warning: The syringe and syringe extension set should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within and in accordance with the hospital/homecare provider's disposal practices. Warning: Drugs for infusion to be used with the pump may only be prescribed by a qualified medical practitioner. Caution must be exercised in the selection of drugs and the amount and rate intended to be delivered via the pump. Warning: Disposables (as with any infusion) used with the syringe pump must be compatible with the drug/fluid being delivered and the expected environmental conditions where the infusion might take place (i.e., Sunlight, Heat, Cold, Humid, High Altitude, etc.). Check with the manufacturer of the disposables before use. Consult the fluid or drug manufacturer’s information for precautions, guidelines, and instructions for preparation and use of disposables. Warning: As with all automatic syringe pumps, whenever a toxic or dangerous level of drug is stored in the reservoir, constant/frequent monitoring of the infusion is required. Warning: In all applications, time to alarm under occlusion or other fault conditions will depend on the infusion rate and levels of alarm settings. It is recommended to consider these parameters when using drugs requiring infusion stability or low flow rates and therefore a quick time to alarm. Caution: Do not use slip-tip syringes. Luer-lock syringes must always be used to ensure secure connection of the syringe extension set and the syringe pump.

2.4. General Precautions and Warnings Warning: The maximum volume that may be infused under single fault condition is 0.1 mL. Warning: Potential strangulation may occur if the cables/tubing are of excessive length. Warning: Potential choking may occur if small parts are inhaled or swallowed. Warning: Potential allergic reactions may occur due to materials used in the pump. Warning: The pump is not certified for use in oxygen-enriched environments. Warning: Do not operate the syringe pump near high-energy radio-frequency emitting 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 syringe pump, which may affect proper infusate delivery. Caution: Do not use hard or sharp objects on the keypad. Caution: Do not bathe or shower whilst using the pump. The pump is resistant to a limited amount of splashing, but its construction does not make it resistant to large amounts of spraying or immersion in liquids. Damage to the internal components may result. 8

BD BodyGuard™ T Directions For Use - Rev. 04

3. Pump Description

3. Pump Description 3.1. Syringe Fitting

Item

Description

1

Barrel clamp arm sensor

Detects syringe barrel loading and secures the syringe in place.

2

Collar sensor

Detects correct loading of the syringe collar.

3

Plunger sensor

Detects correct loading of the syringe plunger.

4

Lead screw

Moves the actuator.

5

Guide rails

The two guide rails support the actuator position.

6

Actuator

Drives the syringe plunger to deliver syringe contents.

7

Barrel clamp arm sensor

Detects syringe barrel loading and secures the syringe in place.

8

Syringe collar

-

9

Syringe plunger

-

10

Plunger sensor

Detects correct loading of the syringe plunger.

11

Actuator

Drives the syringe plunger to deliver syringe contents.

12

Collar sensor

Detects correct loading of the syringe collar.

BD BodyGuard™ T Directions For Use - Rev. 04

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3. Pump Description

3.2. Pump Keypad

Icon 1

T

T34™

N/A

N/A

2

Name

Description

LCD display screen Displays pump and infusion status, programming choices and instructions. Info Menu key

l l

l l

3

Up key

l l

4

Down key

l l

5

Start / OK key

l l

6

Stop / No key

l l

7

Move Actuator Forward key

l

l l

Pressing once during infusion displays an infusion summary. Pressing a second time during infusion displays the current battery level. When the pump is in standby mode, accesses the main (Info) menu. Activates/deactivates keypad lock. Scrolls between options. Increases infusion parameters during programming/titration. Scrolls between options. Decreases infusion parameters during programming/titration. Confirms selection. Starts infusion. Takes the user one step back during programming. Stops infusion. Moves the actuator forward when no syringe is in place and the barrel clamp arm is down. Accesses purge function (if enabled). Accesses bolus function (if enabled).

8

Move Actuator Back key

Moves the actuator backward when no syringe is in place and barrel clamp arm is down.

9

ON / OFF key

Powers the pump on and off.

LED indicator

l

10

N/A

N/A

l l

l

The LED indicator light is a steady green during system self-tests. The LED indicator flashes green to indicate infusion delivery. The LED indicator is a steady yellow when the pump is in standby mode or to indicate a low-priority alarm. The LED indicator flashes red to indicate a high-priority alarm.

NOTE: Icons of BD BodyGuard™ T Syringe Pump are used as reference throughout the instructions.

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BD BodyGuard™ T Directions For Use - Rev. 04

3. Pump Description

3.3. Rear of the Pump

Item

Description

1

Pump information Labelling (including universal symbols) identifies the pump's manufacturer and and symbols communicates information on safety, use and performance.

2

Battery compartment

Includes instructions for inserting the battery correctly.

3

Unique Device Identifier (UDI)

The UDI identifies the pump.

3.4. Symbols Symbols on Both Pump and Syringe Extension Set Packaging Symbol

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

Symbols on Pump or on Pump Packaging 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. Date of manufacture

BD BodyGuard™ T Directions For Use - Rev. 04

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3. Pump Description

Symbol

Description 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.

Type CF applied part (IEC 60601-1). Applied part is suitable for direct cardiac application.

Serial Number Battery Direct current Degree of particle and water ingress protection. Protection from solid objects ≥ 12.5 mm and from dripping water when tilted at 15°. (On packaging) Indicates the temperature limits to which the medical device can be safely exposed.

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

(On packaging) Indicates the acceptable upper and lower limits of relative humidity.

Symbols on Syringe Extension Set Packaging Only Symbol

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

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

The fluid path is non-pyrogenic.

Indicates syringe extension sets for single use with pressure infusion apparatus.

Sterilized with ethylene oxide. Lot number Expiry date of disposable

3.5. Post Occlusion Bolus Reduction System (POBRS) During an occlusion, the pressure in the downstream section of the line and/or inside the syringe can increase above the occlusion pressure defined in pump settings. When the pump alarms the user must check the line and attempt to clear the occlusion. During an occlusion the pump’s Post Occlusion Bolus Reduction System (POBRS) feature will reverse 12

BD BodyGuard™ T Directions For Use - Rev. 04

3. Pump Description

the operation of the motor and drive the actuator backwards otherwise the pressure build-up could cause a surge of fluid into the patient on release of the occlusion. When the infusion is resumed, the user will notice that the volume to be infused (VTBI) increases and the volume infused (VI) decreases to indicate the pump back off feature and the infusion time remaining increases; this protects the ml/h infusion rate. Following activation of the POBRS and if the user presses to resume the infusion VTBI increases and the VI decreases to indicate the pump back off feature. Intermediate Rate

Occlusion Pressure

Unintended Bolus Volume

5 ml/h

200 mmHg (minimum) ≤ 0.5 ml 1500 mmHg (maximum) ≤ 0.5 ml An occlusion may pressurize the infusion tubing and syringe, which can result in an unintended bolus of drug when the occlusion is cleared. In order to prevent this additional 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.

Occlusion Pressure The occlusion pressure of a pump is the pressure in the system, registered at the pump, when the pump is still operating but cannot sustain the flow rate. The resultant build-up of pressure sets off the occlusion alarm.

Occlusion and Response An occlusion alarm can be activated by: A blockage in the delivery tubing – often inadvertently caused by kinking or leaving a clamp or a tap closed. A clotted-off cannula. l A partially occluded cannula – if it causes the required driving pressure to rise above the occlusion alarm level. l A very long or narrow bore cannula or/with extension line. Occlusion response is characterised in terms of three measurable parameters: l l

1. Pressure to alarm. 2. Time to alarm. 3. Bolus release when occlusion is resolved. 1. Pressure to alarm If an occlusion occurs the pump attempts to maintain sufficient pressure on the fluid to cause it to flow through all restrictions and overcome any additional resistance. Although fluid is incompressible, the syringe extension set and other components of the system have some give (compliance) and the tubing can expand under the increasing pressure. Other components of the system, such as the bung of the syringe, become compressed. This expansion and compression takes some time to occur. 2. Time to alarm If the occlusion is present from the beginning of the infusion, the time to alarm will increase. The pressure in the pumping chamber increases from zero at the start of the infusion up to the alarm level. This is the most likely situation, as leaving clamps closed is the most usual cause of occlusions. If the occlusion occurs after the pump has stabilised at its set flow rate, the alarm time will not be unusually long as the pressure in the pumping chamber increases from the already high running pressure up to the alarm level. Generally, shorter time to occlusion alarm occur with high flow rates, small syringes and good quality syringes. 3. Unintended bolus release In the case of a complete occlusion, there is no flow to the patient whilst pressure in the system is increasing. When the occlusion is released, the build-up of fluid in the tubing can result in a bolus being delivered to the patient.

BD BodyGuard™ T Directions For Use - Rev. 04

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4. Installation and Setup

4. Installation and Setup 4.1. Pump Inspection and Unpacking To unpack the pump, do as follows: 1. Carefully remove the pump from the box. 2. Ensure that no items were damaged during shipment or storage. 3. Ensure that you have the following items: l BD BodyGuard™ T Syringe Pump l Directions For Use (this manual) l Quick Reference Guide 4. Verify that the date and time are accurate before starting the infusion by checking the last entry in the event log (refer to section 7.5. Event Log on page 39). If the date and time are not correct, adjust the date and time (refer to section 6.3. Changing Pump Settings on page 33). If any items are missing or damaged, contact your supplies department. Warning: Visually inspect packaging and contents before each use. Warning: Do not use the pump and accessories if there are any obvious signs of damage. Return for inspection by authorised service personnel.

4.2. Battery Power Supply Refer to section 5.7.3. Checking the Battery Level on page 28 for checking battery levels.

Battery Types and Use Always use a 9V alkaline disposable battery with the following attributes (refer to battery manufacturer's information): l

Designation: IEC: 6LR61 Warning: Do not use batteries marked 6LP3146 or 6LF22 with the pump. 6LP3146 and 6LF22 batteries can cause issues with the operation of the syringe pump, as the physical construction and internal resistance of this type of battery are different to the 6LR61 battery. Issues arising from use of 6LP3146 and 6LF22 batteries can include end of battery messages during pre-loading, volume test fails, pressure test/calibration issues and reduced amount of infusions from a battery. Warning: 9V batteries may have a sudden drop in voltage, causing the infusion pump to stop abruptly. If the battery voltage drops below the operational threshold, the pump will shut down and the Backup Buzzer will sound for at least 3 minutes. In the event of a sudden pump shutdown, contact your Clinician, Biomed or BD Representative.

Expected Battery Life Delivery Rate (ml/h)

Operating Time (h)

1

> 50

5

> 35

Battery life has been tested under the following conditions: l l l l

BD Plastipak™ 20 ml and 50 ml syringes, syringe extension set M100-172SB, distilled water. Battery: VARTA Power One, manufacturer’s P/N 4122210531. Battery: DURACELL® Ultra, manufacturer’s P/N MX1604. Battery: DURACELL® Plus, manufacturer’s P/N MN1604.

The battery life could be impacted by a number of factors, such as: l l l l l l l

14

Programmed flow rate Syringe size and brand Syringe diameter Syringe friction Battery type and brand Battery operating temperature Back pressure BD BodyGuard™ T Directions For Use - Rev. 04

4. Installation and Setup

l l l l l

Frequency of use, backlight, and alarms Operating temperatures Battery type, brand and capacity Battery storage conditions Battery age NOTE: These values were developed based on laboratory testing using distilled water and new batteries with a minimum of 4 years left for storage life remaining per the labelling. The pumps had minimal interactions and no alarm conditions beyond near end of infusion and end of infusion alarms that were attentively addressed.

The pump battery meter displays battery life remaining as a percentage (%): l l

When the battery power is low a low battery alert will activate. When the battery power is almost depleted, an end of battery alarm will activate.

Changing the Battery Guidance for battery changing may vary for different areas according to local policy, where the pump is to be used and who is managing the pump (healthcare professional or patient as end user). When the pump is being managed in an environment where designated personnel are available at all times to change a battery (if necessary), the low battery alarm provides warning at least 30 minutes before the battery ends. Low battery alarm can be used as an indication to change a battery. When you change the battery, follow these recommendations: l l l l

Use only new batteries. Use only valid (non-expired) 9V batteries in the device. Do not use batteries with signs of rust, bad odour, overheating, or other irregularities. Avoid any contact of the battery with liquids. Warning: DO NOT use scissors or metal objects to remove a battery. Warning: If a battery is too tight, do not try to force it into the battery compartment as this may damage the battery contacts. Warning If the pump is being managed in an environment where designated personnel are unavailable to change a battery with 30-minutes (low battery alarm) notification, the following rule applies: During set-up, confirm that the battery level is sufficient to complete delivery of the full infusion.

To insert the battery into the syringe pump: 1. Slide the compartment cover off at the back of the syringe pump. This reveals the empty battery compartment, with insertion instructions.

2. Push the battery into the compartment taking care to ensure that the battery + / − contacts are aligned on the label inside the compartment.

BD BodyGuard™ T Directions For Use - Rev. 04

15

4. Installation and Setup

NOTE: The battery should fit securely to ensure good electrical contact. 3. Slide the cover back on.

To remove the battery from the syringe pump: 1. Slide the compartment cover off at the back of the syringe pump. 2. Remove the battery. 3. Slide the cover back on.

Backup Battery Depletion If the internal backup battery has been depleted, the pump displays an alarm and requires to enter the current date and time. To enter date and time, do as follows: 1. Press the

key.

2. Press the

key or the

NOTE: Press the

key to change year, then press the

key.

key to go back to the previous step.

3. Press the

key or the

key to change month, then press the

key.

4. Press the

key or the

key to change date, then press the

key.

5. Press the

key or the

key to change hour, then press the

key.

6. Press the

key or the

key to change minutes, then press the

key.

4.3. Accessories (Optional) The following accessories are available:

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BD BodyGuard™ T Directions For Use - Rev. 04

4. Installation and Setup

Lockbox (supplied with two keys) Carry pouch (reusable or disposable) Refer to your local sales representative or BD website for information on types, codes and costs. l l

Warning: Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the pump distributor. NOTE: If any items are missing or damaged, contact your supplies department.

Lockbox Lockboxes are designed to help protect the syringe from displacement and/or tampering. Lockboxes are made from polycarbonate due to its high impact, temperature resistance and optical properties. Lockboxes are available in clear plastic. l l

The lockbox can be used with any drug delivery route. The lockbox fits most commonly used syringe brands and sizes up to 30 ml. NOTE: The design of the syringe extension set may prevent the lockbox from fully closing and locking.

To use the lockbox, do as follows: 1. 2. 3. 4.

Load the syringe on the pump and connect tubing. Open the lockbox. Use the standard key that operates all lockbox types. Place the pump into the lockbox so that the display screen and the keypad line up with the cut-out opening. Guide the syringe extension set out of the slot at the side of the top section and close the lockbox.

Carry Pouch The carry pouch protects the pump functionality and the medication in the syringe whilst the pump is infusing during transportation or patient ambulation. The pouch will also protect the pump from damage or syringe displacement. Disposable and reusable (washable) carry pouches are available. When using the reusable (washable) carry pouch, it is possible to access the display screen and the keypad of the pump during infusion by lifting the flap of the carry pouch whilst the pump remains in the carry pouch. When using either a reusable (washable) or disposable (single patient use) carry pouch it is possible to remove the forward part of the pump during infusion from the carry pouch to inspect the syringe without removing the rear section of the pump. Carry pouches can be carried on the shoulder or around the waist for convenience.

BD BodyGuard™ T Directions For Use - Rev. 04

17

5. Operation

5. Operation 5.1. Disposables Warning: Component damage may occur if the syringe extension set is not correctly attached to the syringe. Assure all connections are secure: Do not over-tighten. This will help minimise leaks, disconnection and component damage. Warning: Disposables (as with any infusion) used with the syringe pump must be compatible with the drug/fluid being delivered and the expected environmental conditions where the infusion might take place (i.e., Sunlight, Heat, Cold, Humid, High Altitude, etc.). Check with the manufacturer of the disposables before use. Consult the fluid or drug manufacturer’s information for precautions, guidelines, and instructions for preparation and use of disposables. Warning: Replace the syringe and/or syringe extension set in accordance with local guidelines. Warning: Use aseptic technique when filling the syringe and priming the syringe extension set. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components and do not re-use single-use syringe extension sets. Warning: Syringes and syringe extension sets should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within, in accordance with the hospital/homecare provider’s disposal practices.

5.1.1. Syringes The pump is programmed to recognize the most commonly used syringes from 2 ml to 50 ml. Luer lock syringes should always be used to ensure secure connection of the syringe extension set and syringe. To avoid accidental selection of an incorrect brand of syringe during setup, it is recommended to disable all syringe types not in regular use. Unused syringe types can be disabled by a BD certified technician. Warning: Do not use slip tip syringes. Luer lock syringes must always be used to ensure secure connection of the syringe extension set and the pump. Should you need to operate the pump with a syringe manufacturer and/or brand other than those listed here, please consult either your local medical engineering department or BD Service Center.

Default Syringe Brands Configured for Use with the Pump Manufacturer

Syringe Sizes (ml)

B. Braun Omnifix®

2

5

10

20

30

50

BD Plastipak™

3

5

10

20

30

50

Monoject™

3

6

12

20

35

-

Codan/Once

-

-

10

20

30

50

Terumo

-

5

10

20

30

50

Nipro

-

5

10

20

30

50

Syringe Volumes Due to the physical length of the lead screw that drives the syringe plunger forward, there are limits to the maximum amount of infusate that can be delivered from larger syringes and, on some smaller syringes, there is an undeliverable volume of infusate that will remain in the syringe, once the actuator has driven to the zero position.

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BD BodyGuard™ T Directions For Use - Rev. 04

5. Operation

Warning: B. Braun Omnifix® 2 ml, BD Plastipak™ 10 ml, Codan 10 ml, Monoject™ 3 ml, Monoject™ 12 ml, Monoject™ 35 ml, Nipro 10 ml and Nipro 20 ml syringes cannot empty completely, potentially a small volume of infusate will remain in the syringe due to limitations of the pump and the syringes design. The pump will display the volume as, for example, Vol 5 (of 5.2) ml. In this example the pump can only deliver 5 ml of the 5.2 ml in the syringe and when the pump has driven the syringe plunger as far forward as possible, 0.2 ml will remain in the syringe. The potential volumes that might remain in the syringes are listed in the table below: Syringe size and brand

Undeliverable infusate volume

B. Braun Omnifix® 2 ml

0.000 ml to 0.114 ml

BD Plastipak™ 10 ml

0.000 ml to 0.177 ml

Codan/Once 10 ml

0.000 ml to 0.043 ml

Monoject™ 3 ml

0.000 ml to 0.007 ml

Monoject™ 12 ml

0.000 ml to 0.388 ml

Monoject™ 35 ml

0.000 ml to 0.348 ml

Nipro 10 ml

0.000 ml to 0.094 ml

Nipro 20 ml

0.000 ml to 0.006 ml

Warning: Some manufacturers have several brand names within their ranges (for example, B. Braun Omnifix® and B. Braun Original Perfusor®). Only use the brands named above with the pump, as failing to do so could result in an under- or over-infusion.

Maximum Fill Volume for Syringes 20 ml to 50 ml Syringe brand

Syringe size 20 ml

30 ml

35 ml

50 ml

B. Braun Omnifix®

20 ml

24 ml

-

37.4 ml

BD Plastipak™

17.9 ml

23.1 ml

-

35.2 ml

Codan

20 ml

22.7 ml

-

36 ml

Monoject™

20 ml

-

28.6 ml

-

Nipro

20 ml

21 ml

-

35.7 ml

Terumo

19.3 ml

24.4 ml

-

38.3 ml

Time to Alarm from Occlusion Flow Rate

Pressure Threshold

Time to Alarm (hh:mm:ss)

5 ml/h

200 mmHg

TTA < 00:06:00

1 ml/h

200 mmHg

TTA < 00:35:00

0.1 ml/h

200 mmHg

TTA < 06:00:00

5 ml/h

1500 mmHg

TTA < 00:25:00

1 ml/h

1500 mmHg

TTA < 03:45:00

0.1 ml/h

1500 mmHg

TTA < 24:00:00

NOTE: Time to alarm tested at flow rates and occlusion thresholds as described in the table above, using a BD Plastipak™ 20 ml syringe.

5.1.2. Syringe Extension Sets The pump can be operated with any extension set with a Luer lock connection. However, it is recommended, to optimise system accuracy and performance, that proprietary syringe extension sets from BD are used. In the range of BD syringe extension sets there are configurations with siphon/free-flow protection.

BD BodyGuard™ T Directions For Use - Rev. 04

19

5. Operation

Features and Characteristics Feature

Description

Materials

The syringe extension sets are manufactured using PVC materials that do not contain latex or di-2-ethylhexyl phthalate (DEHP).

Tubing

Micro-bore: require small priming volumes. Anti-kink: to prevent kinking or occlusion particularly in configuration. Various lengths are available.

Slide clamp

Clamps: to prevent fluid flow to patient (optional on some sets).

Pressure-activated antisiphon/anti-reflux valve

Some BD syringe extension sets contain a combination check valve to prevent uncontrolled flow of fluid either into or from the patient. The syringe extension set with pressure-activated anti-siphon/anti-reflux valve reduces the potential for gravity flow and backflow (backtracking). The pressure-activated anti-siphon valve requires pressure to open. The pump occlusion pressure setting may require adjustment to prevent occlusion alarms. The combination check valve enhances pump functioning by: l Preventing siphoning (free-flow) in the event the set is detached from the pump or mechanical malfunction, and l Preventing reflux (back-flow) in the event several infusion pumps are connected simultaneously to the same patient.

Luer Lock end connector

The syringe extension set is designed to be connected to Luer lock syringes. Luer lock syringes allow a connection between male and female Luer. This provides a secure connection and prevents accidental removal.

Warning: Ensure the syringe extension set is NOT connected to the patient during priming. Warning: A kinked/occluded syringe extension set may impair the operation and accuracy of the pump. Before operation, verify that the syringe extension set is not kinked or occluded. NOTE: The recommended syringe extension set change interval is 72 hours.

5.2. Setting Up the Mode of Operation You can configure the pump for a continuous infusion by duration or rate, and lock the pump program: Duration mode: The pump uses syringe volume and duration to calculate the infusion rate. If the pump program is locked, the default duration cannot be changed. l Rate mode: The pump uses syringe volume and rate to calculate the infusion duration. If the pump program is locked, the default rate cannot be changed. By default, the pump is set to duration mode (24 hours) and the pump program is locked. l

To change the mode of operation, do as follows (refer to section 6.3. Changing Pump Settings on page 33): To use the pump in duration mode, set the Default Duration setting to a value greater than 00:00. To use the pump in rate mode, set the Default Duration setting to 00:00. To change the default rate, refer to section 6.4. Changing Rate Setting on page 34. To lock/unlock the pump program, do as follows (refer to section 6.3. Changing Pump Settings on page 33): l l

l

Set the Program Lock setting to ON (the pump program is locked) or OFF (the pump program is unlocked). WARNING: For the correct pump configuration, mode of operation and start-up sequence, you must refer to your local policies.

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BD BodyGuard™ T Directions For Use - Rev. 04