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.
Coming Soon ...
Instraspec Contour® with Smoke Extraction
Surgical smoke is a contentious subject. More reports are being published about the risks resulting from surgical smoke inhalation yet using smoke extraction equipment can be seen as a nuisance, a barrier to hitting targets by slowing procedures down.
Clinical staff are concerned about the risks from surgical smoke inhalation and there are growing pressures to catch up with the back log of patients waiting for cervical biopsies, yet it must not be at the expense of their own health.
The Risks of Surgical Smoke Inhalation
Vernacare recommend the use of Instraspec Contour® with smoke extraction as part of a complete smoke extraction system, to be used when performing any LEEP/LETZ procedure of the cervix, to reduce the risk of smoke inhalation and improve clinician visibility of the surgical site.
HPV DNA has been detected in surgical smoke in a large number of studies
Viable HPV particles released during diathermy are likely to be associated with significant health risks
Can contain contaminants that cause a number of clinical complications
Visit the links below for further information on the subject:
CSJ - March 2022 (Surgical Smoke Inhalation: Staff Fear Infection Risk)
IPP - November 2021 (Surgical Smoke Practice: Stop Smoke in the OR)
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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
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®?
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We have a team of specialists available if you want to know more about the features and benefits of Instraspec Contour®.