Device Description; Intended Use Of Sheaths; Contraindication; Available Models And Combination Products - Delmont imaging D300 110 000 Manuel D'utilisation

Instructions for use: hysteroscopy system
This manual is for references: D300 110 000 to D300 110 050.

1. Device description

Delmont imaging has a wide range of hysteroscopy instruments for use during gynecology procedures. The hys-
teroscopy system include hysteroscopy sheaths, obturators and adaptors.
Carefully read these instructions before using Delmont imaging hysteroscopy systems. Keep them
in a safe place for future reference.
1.1.

Intended use of sheaths

Continuous flow hysteroscopy sheaths permit visual examination and operational procedures, endoscopically, in
the cervical canal and the uterine cavity.
The products must be used only in medical facilities by trained and skilled medical personnel. The products must
not be used if according to a qualified physician, the general condition of the patient is not adequate or if the
endoscopic methods are contraindicated.
1.2.

Contraindication

Do not use the devices if one or more below reported condition is present:
- acute inflammation of the inner genitals,
- strong uterine bleeding gravidity,
- the device has been already used to treat patients with suspected or verified BSE, CJK / vCJK diseases.
Surgical patients identified as at-risk for Creutzfeldt-Jakob disease (CJD) and related infections
should be treated with single-use instruments. Therefore, devices that have been in use or suspected of
use on a patient with CJD after surgery must be disposed according to current national recommendations.
Improper use can lead to hazardous situations.

2. Available models and combination products

Please refer to section «Attached Document» for further information.
An incorrect combination of products can lead to injury for patients, users or third parts as well as
product damage.

3. Reprocessing instructions

Products are delivered in a non-sterile state and must be cleaned, disinfected and sterilized before the
first and subsequent use.
D900 700 026 B Rev 07/2018
delmont
imaging
3