Autoject®2 Self Injection Device Standard Fixed
Autoject®2
Injection & InfusionSelf-injection device / auto-injector
Certifications
- CE Marked medical device (EU/UK regulatory compliance as an auto Injector for subcutaneous injection).
- Designed and tested in line with relevant auto Injector and assistive device standards such as ISO 11608 1 and EN 12182 (as stated in manufacturer technical documentation).
- Intended for single Patient reuse in accordance with the instructions for use and applicable infection Prevention guidance.
- CE Marked medical device (EU/UK regulatory compliance as an auto Injector for subcutaneous injection).
- Designed and tested in line with relevant auto Injector and assistive device standards such as ISO 11608 1 and EN 12182 (as stated in manufacturer technical documentation).
- Intended for single Patient reuse in accordance with the instructions for use and applicable infection Prevention guidance.
Self-injection device / auto-injector
Description
Autoject®2 Self-injection Device - Standard Fixed is a reusable mechanical auto-injector designed for use with most major brands of fixed-needle disposable syringes (typically 0.3 ml, 0.5 ml and 1.0 ml). It conceals the needle from view and automates the injection process at the touch of a button, inserting the needle to a preset depth and delivering the syringe contents into the subcutaneous tissue. The device includes an adjustable needle-depth mechanism, integrated safety lock to prevent accidental firing, and a large viewing window to inspect the syringe. Autoject®2 is intended to make self-injection simpler and more manageable for patients who find manual syringe injections difficult or anxiety-provoking, including children, older adults and those with limited dexterity.
Bnefits
- Conceals the syringe and needle to reduce anxiety in needle-phobic patients.
- Automates needle insertion and medication delivery at the touch of a button.
- Compatible with a wide range of fixed-needle disposable syringes (e.g. insulin and other subcutaneous medications).
- Adjustable needle penetration depth for more comfortable and effective subcutaneous delivery.
- Safety interlock prevents accidental firing until the device is pressed against the skin.
- One-handed operation allows access to more injection sites and improves self-reliance.
- Large viewing window allows visual confirmation of the syringe and dose before and after injection.
- Reusable device with robust construction designed for long-term use when maintained correctly.
- Supplied with depth adjusters and primer to help healthcare professionals set an appropriate needle depth for each patient.
- Can support improved adherence to injection regimens by simplifying the technique and standardising delivery.
Indications
- Automated subcutaneous injection of syringe-based medications using compatible fixed-needle disposable syringes.
- Facilitation of self-injection in patients who have difficulty using syringes manually (e.g. reduced dexterity, visual impairment).
- Support for patients with chronic conditions requiring regular subcutaneous injections such as diabetes (insulin therapy) and other syringe-based therapies prescribed for subcutaneous use.
- Use as a needle-concealing injection aid in patients with needle anxiety or needle phobia when subcutaneous injection is required.
Composition
- Reusable mechanical auto-injector body manufactured from medical-grade polymers and metals.
- Internal spring and trigger mechanism to automate needle insertion and plunger depression.
- Interchangeable depth adjusters for fixed-needle syringes (short and long depth adjusters).
- Yellow plastic primer/depth guide for setting and verifying penetration depth during setup.
- Integrated safety lock, protective cap and viewing window.
- Compatible with most fixed-needle disposable plastic syringes in the 0.3 ml, 0.5 ml and 1.0 ml size range (syringes not included).
Formulation
- Not applicable. This is a reusable mechanical injection device intended for use with compatible pre-filled or manually filled disposable syringes.
Packaging
- 1 x Autoject®2 Fixed Needle self-injection device.
- 2 x depth adjusters for fixed-needle syringes (short and long).
- 1 x yellow primer/depth guide.
- 1 x carrying wallet or case (varies by distributor configuration).
- 1 x printed instructions for use (IFU) leaflet.
- Supplied non-sterile as a reusable external device; compatible disposable syringes are supplied separately.
Usage
- Before first use, a healthcare professional should determine the appropriate needle penetration depth and demonstrate use of the device.
- Select a compatible fixed-needle disposable syringe (e.g. insulin syringe) and prepare the medication dose according to the medicinal product’s instructions.
- Fit the appropriate depth adjuster to the Autoject®2 body, using the yellow primer/depth guide if provided to set the recommended penetration depth.
- Load the filled syringe into the syringe housing and insert the housing into the injector body as described in the instructions for use, ensuring it is fully seated.
- Engage the safety lock and fit the protective cap as instructed while preparing for the injection site.
- Choose and clean the injection site according to clinical guidance for subcutaneous injections.
- Place the Autoject®2 firmly against the skin at the chosen injection site so that the safety interlock is fully depressed.
- Release the safety (if applicable) and press the activation button to fire the device; Autoject®2 will insert the needle to the preset depth and depress the syringe plunger.
- Keep the device pressed against the skin for the recommended hold time to ensure full dose delivery, then remove it from the skin and check the syringe through the viewing window.
- Dispose of the used syringe safely in a sharps container, reapply the protective cap to the device and store Autoject®2 according to the instructions for use.
- Refer to the official instructions for use for full operating details, compatible syringes and safety precautions.
Contraindications
- Do not use with glass syringes unless explicitly stated as compatible by the manufacturer; the standard fixed-needle model is generally specified for use with fixed-needle disposable plastic syringes only.
- Not intended for intravenous, intramuscular or intradermal injection unless specifically instructed by a healthcare professional and compatible with the medication being used; Autoject®2 is primarily designed for subcutaneous injections.
- Do not use in patients who cannot understand or follow the operating instructions and who do not have an appropriate caregiver trained to operate the device.
- Do not use if the device is visibly damaged, if internal mechanisms appear to be malfunctioning, or if the safety lock and trigger do not function as described in the instructions for use.
- Do not operate the device without a syringe inserted or with an empty syringe, as this may damage the mechanism or cause injury.
- Use only with syringe sizes and brands listed as compatible in the official compatibility chart and instructions for use.
Adverse Effects
- Local injection-site reactions such as pain, redness, bruising, swelling or minor bleeding, similar to those seen with manual subcutaneous syringe injections.
- Potential for incomplete dose delivery or leakage if the device is not correctly assembled, loaded or held against the skin for the recommended duration.
- Skin indentation or transient discomfort at the injection site related to needle penetration and spring-driven delivery.
- Very rare risk of device malfunction leading to no injection or partial injection; patients should be trained to recognise and report this and follow healthcare professional guidance.
- As with any needle-based injection, there is a risk of infection at the injection site if aseptic technique is not followed.
- Any medication-specific adverse effects are related to the drug being injected, not to the Autoject®2 device itself.
Storage Conditions
- Store the Autoject®2 device at room temperature in a clean, dry environment.
- Protect from excessive heat, direct sunlight and moisture.
- Keep the device in its protective wallet or case when not in use to reduce the risk of mechanical damage.
- Ensure the device is kept out of the reach of children and unauthorised users.
- Do not immerse the device in water or disinfectant solutions; clean only according to the manufacturer’s instructions (typically by wiping the outer surfaces with a soft, slightly damp cloth and allowing to dry).
Duration
Reusable device intended for long-term use over the lifespan of the product; treatment duration and injection frequency are determined by the prescribed medication regimen.
Onset
Onset and duration of effect are determined by the specific medication delivered and its route of administration, not by the Autoject\u00ae2 device itself.
