Ambulatory Syringe Pump (BD BodyGuard™ T Syringe Pump)

Becton Dickinson

Infusion Devices / Syringe Pumps

Ambulatory syringe infusion pump (2\u201350 ml syringes)

CE Marked medical device (CE 0344, as indicated on BD BodyGuard™ T product information and labelling for the EU/UK market)
Designed and tested to relevant IEC 60601 1 general safety standards for medical electrical equipment and IEC 60601 2 24 particular requirements for infusion pumps and controllers
Ingress protection rating IP22 and insulation class II, type CF applied part (per technical literature)
Manufactured under BD’s ISO 13485 Certified quality management system for medical devices
Conforms to applicable regulations for ambulatory infusion pumps in the regions where marketed (for example, EU Medical Device Regulation / legacy Medical Device Directive, and corresponding UK requirements)

CE Marked medical device (CE 0344, as indicated on BD BodyGuard™ T product information and labelling for the EU/UK market)
Designed and tested to relevant IEC 60601 1 general safety standards for medical electrical equipment and IEC 60601 2 24 particular requirements for infusion pumps and controllers
Ingress protection rating IP22 and insulation class II, type CF applied part (per technical literature)
Manufactured under BD’s ISO 13485 Certified quality management system for medical devices
Conforms to applicable regulations for ambulatory infusion pumps in the regions where marketed (for example, EU Medical Device Regulation / legacy Medical Device Directive, and corresponding UK requirements)

Ambulatory syringe infusion pump (2\u201350 ml syringes)

Description

The BD BodyGuard™ T Syringe Pump, sold by Medisave as the Ambulatory Syringe Pump, is a compact, lightweight ambulatory infusion device designed to deliver medications or fluids from 2–50 ml syringes with high precision. It supports continuous and bolus infusion modes and features automatic syringe recognition with a three-point detection system, volume detection with automatic rate calculation, a comprehensive alarm system and a large, user-friendly interface. Intended to support effortless transition between hospital and home care, the pump improves patient mobility and independence while providing robust safety features including lockable keypad, multiple security access code levels, event logging and detailed on-screen messages.

Bnefits

Small, lightweight and compact design to improve patient mobility and comfort during ambulatory infusions
Compatible with a wide range of commonly used syringe brands and sizes from 2 ml to 50 ml
Three-point automatic syringe detection with displacement alarms for fast, reliable set-up and syringe recognition
Volume detection and automatic calculation of infusion rate in ml/h to simplify programming and reduce calculation errors
Supports continuous and bolus infusion modes to cover a broad range of clinical therapies
Lockable keypad and multiple levels of code-protected functions to minimise accidental key presses and unauthorised programme changes
Comprehensive alert and alarm system with descriptive messages on a large display for rapid troubleshooting
Event log and infusion history viewable on the pump and downloadable via BodyComm™ software for audit and documentation
Powered by a single 9 V (6LR61) battery with optimised battery life to support ambulatory and home-care use
Linear syringe driver mechanism capable of delivering very small volumes with high precision at low flow rates

Indications

Continuous or intermittent infusion of medications and fluids requiring precisely controlled infusion rates
Palliative care for continuous subcutaneous infusions of analgesics, antiemetics and other symptom-control medicines
Administration of maintenance medications via intravenous, subcutaneous, percutaneous, intra-arterial, in close proximity to nerves or into intraoperative sites, according to local clinical guidelines
Small-dose infusion therapies in hospital, outpatient, community and home-care settings
Therapies where ambulatory infusion improves quality of life by reducing the need for repeated bolus injections

Composition

Pump housing: compact, lightweight enclosure with integral mounting points and user interface (medical-grade plastic construction; specific resin not disclosed in public documentation)
Display and keypad: LCD screen with backlight and soft-touch keypad, including lock function
Syringe mechanism: linear syringe driver with three-point syringe clamp and detection system
Power: 9 V (6LR61) battery compartment and internal electronics for pump control and alarms
Electronics: microprocessor-controlled infusion system with event logging and alarm processing circuitry
Classification: Insulation class II, type CF applied part; ingress protection rating IP22
Connectivity: interface for BodyComm™ software (for data download) via compatible connection cables

Formulation

Ambulatory syringe pump designed for use with 2–50 ml syringes from major manufacturers
Linear drive mechanism controlling plunger movement to deliver precise infusion rates
Three-point syringe detection that recognises syringe size and brand (within configured range) and monitors for displacement
Programmable infusion modes including continuous infusion and bolus delivery
Configurable security features, including lockable keypad and three levels of access codes
Alarm system covering occlusion, end of infusion, low and end of battery, syringe displacement and other critical conditions
Device software supporting duration mode (pump calculates rate from volume and time) and rate / volume-time programming options

Packaging

Each sales unit typically contains: 1 x BD BodyGuard™ T Syringe Pump (REF / SKU 999-103BDEN)
Manufacturer packaging includes the pump, Directions for Use (DFU) and a Quick Reference Guide as standard
Additional accessories such as lockboxes, pouches, pole mounts and power or data cables are available separately under dedicated accessory codes
Medisave lists the product as an Ambulatory Syringe Pump supplied as a single unit at a price of £2,519.99 (inc. VAT, pricing subject to change)

Usage

Use only by healthcare professionals who are trained and familiar with infusion pump operation, following the official Directions for Use and local clinical protocols.
Before use, inspect the pump for visible damage, verify that it has been serviced according to institutional policy and install a suitable 9 V (6LR61) battery.
Select an appropriate compatible syringe (2–50 ml, from a supported manufacturer), draw up or load the prescribed medication, and remove air according to local procedures.
Load the syringe into the pump as described in the DFU, ensuring correct placement in the three-point clamp so that syringe size and brand can be automatically detected.
Programme the infusion using the selected mode (e.g. rate mode or duration/volume-time mode), double-checking all parameters including drug name (if used in protocol), volume, rate, duration and bolus settings where applicable.
Engage keypad lock and security codes as required by local policy to prevent unauthorised or accidental changes.
Connect the extension set and cannula to the prescribed route of administration (e.g. subcutaneous, intravenous) using aseptic technique and secure the line and site according to infection-prevention guidelines.
Start the infusion and confirm that the pump is running, observing the display, status LED and any initial alarm messages.
Monitor the patient regularly, checking the infusion site, line, syringe volume, pump status and for any alarms; respond promptly to alarms following the on-screen guidance and local protocols.
At the end of infusion or if treatment is stopped, clamp the line (if applicable), disconnect safely, power off the pump and dispose of syringes and consumables in accordance with local waste regulations.
Clean the pump exterior using approved cleaning agents as recommended in the DFU, and store or return the device according to institutional policies.
Do not modify the device, use incompatible accessories, or operate the pump outside the environmental and operating limits stated in the DFU.

Contraindications

Use for infusions or routes of administration that fall outside the indications and limits stated in the official Directions for Use or local clinical guidelines.
Use with syringes, fluids or medications that are not approved or compatible according to institutional policy or that might chemically damage the syringe materials or pump components.
Use in explosive or flammable atmospheres (such as in the presence of flammable anaesthetics) unless the device is explicitly approved for such environments.
Use in patients or clinical situations where precise infusion control cannot be adequately monitored (for example, in the absence of appropriate clinical oversight).
Use of damaged, malfunctioning, out-of-service or overdue-for-maintenance pumps.

Adverse Effects

Potential for under-infusion or over-infusion of medications or fluids if the pump is programmed incorrectly or if alarms are ignored or overridden.
Risk of tissue damage, infiltration, extravasation, infection or irritation at the infusion site, consistent with any infusion therapy.
Patient discomfort or anxiety related to wearing or carrying the device during ambulatory use.
Battery depletion during therapy if battery status is not checked and managed according to recommendations, which can lead to premature interruption of infusion.
Mechanical failure or occlusion events if lines are kinked, syringes are incorrectly loaded, or the pump is not used according to the DFU; such events should be mitigated by the built-in alarm system when used correctly.

Storage Conditions

Store the pump powered off in a clean, dry environment at room temperature within the storage conditions specified in the DFU.
Protect the device from moisture, excessive dust, corrosive atmospheres and direct sunlight.
Avoid mechanical shocks, drops or heavy loads on the pump during storage and transport.
Remove the battery if the pump is to be stored for a prolonged period, in line with manufacturer guidance, to reduce the risk of battery leakage.
Store accessories such as lockboxes, pouches and cables in a similarly clean and dry environment, following any specific instructions in their documentation.

Duration

The pump can be programmed for infusion durations from 1 minute up to 99 hours; in clinical practice it is commonly used for continuous subcutaneous infusions over approximately 24 hours in palliative care and for other small-dose infusion regimens as prescribed.

Onset

Not directly applicable to the device; clinical onset of effect depends on the medication infused, dose, route of administration and patient-specific factors.