Automatic syringe injection aid for removable needle syringes
Certifications
Manufactured under ISO 13485 Certified quality management system for medical devices.
Conforms to applicable European Medical Device Directive requirements (e.g. 93/42/EEC) and carries CE marking for medical devices in relevant markets at the time of leaflet publication.
Manufacturer (Owen Mumford Ltd) cites environmental management certification ISO 14001.
Manufactured under ISO 13485 Certified quality management system for medical devices.
Conforms to applicable European Medical Device Directive requirements (e.g. 93/42/EEC) and carries CE marking for medical devices in relevant markets at the time of leaflet publication.
Manufacturer (Owen Mumford Ltd) cites environmental management certification ISO 14001.
Distributed in the UK by Medisave UK Ltd, which holds an MHRA Wholesale Distribution Authorisation (WDA) and operates ISO 9001 and ISO 14001 certified systems for its activities.
Description
The Owen Mumford Autoject 2 Standard Removable is an automatic self-injection aid designed to make syringe-based medication easier and more comfortable for patients of all ages. The device conceals the syringe and needle, helping patients with needle phobia, and automates the injection: at the touch of a button, it inserts the needle to a pre-set depth and delivers the contents of the syringe. The Standard Removable model (AJ1311 / OWAJ1311) is specifically designed for use with a 1 ml BD Tuberculin syringe fitted with a 1/2\ PrecisionGlide removable needle. It features an adjustable needle depth, a safety interlock to prevent accidental firing until pressed against the skin, and clear visual indicators to confirm when the injection is complete. Autoject 2 helps support adherence to prescribed injection regimens in a range of clinical areas including diabetes, hormone therapy, allergy and medical aesthetics.
Bnefits
Automates syringe-based injections, inserting the needle and delivering the dose at the touch of a button.
Conceals the needle from the patient’s view, making it suitable for patients with needle phobia and reducing anxiety.
Safety interlock mechanism prevents accidental firing until the device is pressed against the skin.
Visual dose completion indicator shows when the injection has been successfully delivered.
Needle depth adjuster allows healthcare professionals to tailor depth of penetration for more effective and comfortable drug delivery.
Ergonomic, easy-to-grip design supports one-handed operation and use at a wider range of injection sites, including harder-to-reach areas.
Can make self-injection easier for children, older adults and patients with reduced dexterity or vision.
Reusable device for a single patient, used with disposable syringes and needles to maintain sterility at the injection site.
Indications
Aid for subcutaneous self-injection or caregiver-administered injection in patients who have difficulty using a syringe manually.
Use with 1 ml BD Tuberculin syringes fitted with a 1/2" PrecisionGlide removable needle, for medications prescribed for subcutaneous injection (e.g. insulin, certain hormone therapies, biologics, allergy treatments), according to local labelling.
Distributed in the UK by Medisave UK Ltd, which holds an MHRA Wholesale Distribution Authorisation (WDA) and operates ISO 9001 and ISO 14001 certified systems for its activities.
Intended as a Class II or equivalent risk Category medical device for subcutaneous drug delivery support, subject to local regulatory classification.
Single Patient reusable device with instructions for use consistent with international standards for injection aids and sharps safety practices.
Intended as a Class II or equivalent risk Category medical device for subcutaneous drug delivery support, subject to local regulatory classification.
Single Patient reusable device with instructions for use consistent with international standards for injection aids and sharps safety practices.
Automatic syringe injection aid for removable needle syringes
Support for patients with needle phobia or anxiety related to injections, by concealing the needle.
Use in clinical areas such as diabetes care, endocrine therapy, immunotherapy, medical aesthetics and other subcutaneous drug delivery where syringe-based administration is prescribed.
Facilitation of injections in hard-to-reach sites, enabling more varied site rotation compared with manual syringe injection.
Composition
Reusable mechanical injection aid device (no medicinal product contained).
Components include: injector body, syringe housing and depth adjuster.
Internal spring mechanism to drive the syringe plunger and needle insertion.
Viewing window with indicator marker to show end of injection.
Compatible with 1 ml BD Tuberculin plastic syringes with 1/2" PrecisionGlide removable needle (not supplied with the device).
Manufactured from medical-grade plastics and metals suitable for repeated cleaning as per instructions for use.
Formulation
Product type: Non-sterile reusable automatic injection aid device.
Model: Autoject 2 Standard Removable (AJ1311).
Intended route of injection when used with a syringe: Subcutaneous.
Compatibility: Only for use with 1 ml BD Tuberculin syringe with 1/2" PrecisionGlide removable needle (not for glass syringes).
Mechanism of action: Spring-powered device automatically advances the syringe needle to a pre-set depth and depresses the plunger to deliver the dose when the trigger button is pressed.
Operation: One-handed operation with raised trigger button and adjustable depth setting.
Device classification: Non-active, handheld medical device for drug delivery support (auto-injector aid).
Packaging
Supplied as a single Autoject 2 device in a soft zippered pouch (varies by configuration/market).
Standard set typically includes: 1 Autoject 2 Removable Needle device, 1 depth adjuster (removable needle), and printed instructions for use.
Some configurations may also include a yellow primer/depth guide and additional depth adjusters depending on market.
Retail carton labelled with manufacturer details, model identification (AJ1311 / Autoject 2 Removable Needle) and compatibility information.
Syringes and needles are not included and must be sourced separately as compatible BD Tuberculin syringes with 1/2" PrecisionGlide removable needle.
Usage
Use only with a 1 ml BD Tuberculin syringe fitted with a 1/2" PrecisionGlide removable needle, as specified in the instructions for use.
The device is suitable for subcutaneous injections only – do not use for intramuscular or intravenous injections unless specifically directed by a healthcare professional and local labelling allows.
Before first use, review the full instructions for use supplied with the device. A healthcare professional should demonstrate correct loading, depth adjustment and injection technique.
Depth adjustment: Set the depth adjuster according to advice from a healthcare professional. Each graduation on the depth scale typically represents approximately 2 mm of needle penetration, with a recommended maximum penetration depth of around 12 mm.
Ensure the depth adjuster is correctly engaged and locked in place before loading the syringe.
Loading: Draw up the prescribed medication into the compatible BD Tuberculin syringe and fit the 1/2" PrecisionGlide removable needle following aseptic technique. Insert the filled syringe into the syringe housing of Autoject 2 as directed in the IFU, ensuring it is properly seated and aligned.
Prime the device if required according to the instructions, using the primer/depth guide where supplied.
Injection procedure: Choose and prepare the injection site as advised by a healthcare professional (for example abdomen or thigh for subcutaneous injections). Clean the skin with an appropriate antiseptic wipe and allow to dry.
Place the Autoject 2 against the skin at the injection site so that the safety interlock is engaged. The device will not fire until it is firmly pressed against the skin.
Press the trigger button to start the injection. The device automatically inserts the needle to the pre-set depth and depresses the syringe plunger to deliver the medication.
After firing, hold the device in place for the time recommended in the IFU or by the prescriber to ensure full dose delivery, then remove it from the skin.
Check the dose completion indicator (e.g. yellow marker visible in the window) to confirm that the injection has finished and the full dose has been delivered.
Remove the syringe carefully from the device and dispose of the used needle and syringe immediately into an approved sharps container, in accordance with local guidelines.
Do not share the device between patients. It is intended for single-patient use over multiple injections.
Clean the exterior of the device as recommended in the instructions for use (for example, wiping with a lightly damp cloth). Do not immerse in water, do not autoclave and do not use harsh chemicals or solvents.
Periodically inspect the device for signs of damage or malfunction. If the device is cracked, does not fire correctly, or the mechanism appears faulty, stop using it and contact a healthcare professional or the supplier.
Always follow the advice of a healthcare professional regarding injection sites, rotation schedules and frequency of injections, in line with the medication’s prescribing information.
Contraindications
Do not use in patients who have been advised against subcutaneous injections with syringes by their healthcare professional.
Not suitable for use with glass syringes or syringes other than 1 ml BD Tuberculin syringes with 1/2" PrecisionGlide removable needle, unless specifically stated compatible by the manufacturer.
Do not use for intravenous injections or other routes of administration that are not compatible with the syringe and needle being used.
Do not use if the device is visibly damaged, cracked, or if any part appears to be missing or malfunctioning.
Do not operate the device without a syringe or with an empty syringe, as this may damage the mechanism and compromise safety.
Not intended for multiple-patient use; do not share the device between different individuals due to risk of cross-contamination.
Patients who are unable to understand or follow the instructions for use, and who do not have a trained caregiver, should not use the device without appropriate training and supervision.
Any specific contraindications related to the medication being injected (e.g. certain medical conditions, allergies) remain applicable and must be observed separately from the device instructions.
Adverse Effects
Local injection site reactions related to the medication and needle use, such as pain, discomfort, stinging, redness, bruising or swelling.
Very rarely, incorrect use or inappropriate depth settings may increase the risk of bleeding, bruising, or inadvertent injection too shallow or too deep.
Possible anxiety or distress associated with injections, although the device is designed to reduce this by hiding the needle.
If the device is misused or defective, there is a risk of incomplete dose delivery, requiring re-injection as advised by a healthcare professional.
Any systemic adverse effects will be due to the injected medication itself rather than the Autoject 2 device; such effects should be monitored and reported according to the drug’s prescribing information.
Storage Conditions
Store the device at normal room temperature, away from extreme heat or cold.
Keep the device dry; do not immerse it in water and avoid excessive moisture.
Protect from direct sunlight and sources of contamination.
Store in its pouch or protective case when not in use, to prevent physical damage.
Keep out of the sight and reach of children and pets.
Do not attempt to modify, oil or disassemble the device. If it appears damaged or does not function correctly, replace it or consult the manufacturer or supplier.
Duration
The Autoject 2 Standard Removable is a reusable injection aid intended for long-term use by a single patient to support repeated subcutaneous injections over months or years, subject to normal wear and periodic inspection. The duration of use for the device itself is determined by its mechanical integrity and manufacturer guidance, while the clinical treatment duration is dictated by the prescribed medication regimen and the supervising healthcare professional.
Onset
As a mechanical injection aid, the device acts immediately during each injection: once loaded and positioned, pressing the trigger quickly inserts the needle and delivers the dose within seconds. Any clinical onset of effect depends entirely on the medication being injected, not on the Autoject 2 device.
