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English, Intended use – Welch Allyn Rigid Reusable & Single Use Sigmoidoscopes, Anoscopes and Accessories - User Manual User Manual

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ENGLISH

Intended Use

The Welch Allyn Rigid Reusable and Single Use Sigmoidoscopes and Anoscopes

are used to illuminate and facilitate the examination of the rectal and anal cavity.

The instrument also provides a means of entry for surgical instruments into the

rectal and anal cavity.

Endoscopes and the insufflation system are categorized as semi-critical devices

requiring high level disinfection and the illumination system is categorized as a

non-critical device requiring low-level disinfection according to the Multi-society

guideline for reprocessing flexible gastrointestinal endoscopes published by

Gastrointestinal Endoscopy (volume 58, No. 1, 2003) and simultaneously in

Infection Control and Hospital Epidemiology.

Refer to ASTM F1518-00, Standard Practice for Cleaning and Disinfection of

Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow

Viscera, for additional guidance of reprocessing of these devices/accessories.

Although this standard is for flexible endoscopes, it contains information that can

be applied to rigid endoscopes as well.

Caution: U.S. federal law restricts this device to sale by or on the order of

a physician or licensed healthcare practitioner.This device should only be

used by trained personnel.
Caution: Perform reprocessing immediately after each use.
Caution: Consult your facility's procedures and the reprocessing agents

manufacturer's instructions for the agents reuse, recommended

Personal Protective Equipment and other safety precautions such

as ventilation, etc.
Caution: Examine surfaces of all components for wear or damage after

cleaning, disinfection, and/or sterilization.
Caution: For cleaning and/or disinfection, use brushes appropriate for the

size of the endoscope channel parts, connectors, and orifices

(e.g. bristles should contact all surfaces). Cleaning/disinfection tools

(brushes, etc.) should be single use or thoroughly cleaned, disinfected,

and/or sterilized between uses.

Caution: Unless otherwise specified, perform all reprocessing procedures

at ambient (room) temperature.

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