Instraspec Contour® is an award-winning unique, safe, unbreakable plastic single-use speculum that also delivers exceptional value for money.
Gynaecological examinations and procedures can often be daunting for patients. Both patient and clinician require a vaginal speculum that is safe and comfortable in use, with no risk of cross infection. Instraspec Contour® addresses these needs and more thanks to thoughtful design and the use of advanced materials in its manufacture.
Complete Peace of Mind
Instraspec Contour® is a strong, safe and unbreakable vaginal speculum, offering complete peace of mind to patients and clinicians:
- Safe, unbreakable in normal use and available in 5 sizes for patient comfort
- Class IIa medical device, suitable for:
- All observational and examination procedures
- Surgically invasive procedures
- Ergonomic, contoured profile for trauma-free use
- Anti-pinch hinge and beak design
- Unique gel pockets retain lubricant
- Smooth, silent, rapid opening and closing system
- Pivoting runner for unobstructed visualisation and instrumentation access
- Unique design, developed and tested in the UK
Vaginal speculums are widely regarded as the most suited instrument in the single-use sector due to the complexity to clean a reusable version.
Compliance with Legislation & Standards
It is a legal requirement for all medical devices to comply with the Medical Devices Directive (MDD) 93/42 EEC and carry the CE mark. Regulatory requirements differ according to the risk attached to the use of the product. The lower the risk, the easier it is to comply with the Directive.
Single-use instruments are relatively high risk as many are surgically invasive and therefore classified as lla devices. They are therefore subject to greater levels of control than reusables, which are Class l devices except those used on central nervous tissue. Class l devices can be sold without any authorisation from an independent third party - a Notified Body. Class lla devices require a Notified Body to assess the production of the device to Annex lV, V or Vl of the Directive and issue a certificate of conformance before a CE mark can be applied and the product legally sold.
Certification by the British Standards Institution (BSI) verifies that Instraspec Contour® products meet fully the requirements of the Regulation.
Want to learn more about Instraspec Contour®?
Come and talk to us.
We have a team of specialists available if you want to know more about the features and benefits of Instraspec Contour®.