Hysteroscopes

TruClear™ hysteroscope set duo

<p>The smallest diameter hysteroscope in the TruClear™ portfolio, TruClear™ set duo provides the option of a diagnostic or operative sheath for the office setting.</p>

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Indications, Safety, and WarningsIntended useRigid medical endoscopes are used to visualize body cavities. Each endoscope was developed for diagnostic and surgical procedures in one of the following fields of application:

Arthroscope: arthroscopic procedures

Sinuscope: sinuscopic procedures

Otoscope: otoscopic procedures

Laryngoscope: laryngoscopic procedures

Laparoscope: laparoscopic procedures

Hysteroscope: hysteroscopic procedures

Cystoscope: cystocscopic procedures

For the benefit and safety of patients, physicians must select a method which they consider suitable based on their experience. If you as the user of this endoscope believe that you require more detailed information regarding the product's use and maintenance, please contact your representative.Safety informationThe endoscope may only be used by trained medical professionals in medical facilities.

After delivery, inspect the endoscope for completeness and damage.

Read, observe and keep the instructions for use.

Use the endoscope only as intended, see "2. Intended use" in the instructions for use.

When endoscopic instruments are used together with other electromedical devices, the total patient current leakage may be additive. Ensure BF (CF) conditions are observed when using the endoscopic instruments with electromedical devices.

Failure to use protective filters or suitable filtering spectacles during the activation of a surgical laser beam may cause eye-damage to the user.

The user and/or patient should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Ensure that any modifications or repairs are carried out by persons authorized by HSW. No modifications of this equipment are allowed by the user, or the warranty is void.

For storage, transport and processing, ensure that the endoscope is not subjected to mechanical strain, particularly to prevent damage to the sensitive lens system.Warning: risk of injury due to faulty endoscope

Carry out a visual inspection and function check prior to initial use as well as each additional use.

Only use endoscopes that are in perfect condition.

Clean, disinfect, and sterilize the endoscope prior to initial use as well as each additional use of the endoscope. Contaminants on the irradiation surface of the illumination fibers can burn in during use, which impacts image quality.

Ensure that the proximal end of the endoscope is dry to prevent the endoscope from fogging up during the examination/procedure.

Ensure that no parts are missing or loose.

Ensure that there are no residual cleaning agents or disinfectants on the endoscope.

Inspect the entire endoscope, particularly the sheath, for contaminants and damage of any type, such as dents, scratches, cracks, bending, and sharp edges.

Inspect distal end, proximal end and irradiation surface of the illumination fibers for contamination and scratches. Make contaminants and scratches visible using light reflexes. Hold the connection of the optical fibers against the light and inspect whether the optical fibers illuminate evenly at the distal end.

Check image quality: The image may not be blurry, clouded or dark. If necessary, remove deposits on the optical end surface using polishing paste provided.

For endoscopes with locking device: Inspect between the sheath and the main part for contaminants and damage to ensure a fixed and secure connection.

For endoscopes with working channel: Inspect all components of the adapter with stopcock for function and damage.

Inspect free passage of the working channels.

Warning: risk of infection to the patient or medical professionalsThe endoscopes are delivered non-sterile as reusable products.The state of the art and national laws require the observance of validated processes. In general, users are responsible for the validation of their processes.

Ensure that the processing, material and personnel are suitable for achieving the results necessary.

Observe any valid local operator regulations for all manual cleaning and drying processes.

Clean, disinfect, and sterilize the endoscope prior to initial use as well as each subsequent use of the endoscope.

Bring the endoscope to the decontamination area after use. Observe valid protective measures to prevent contaminating the environment.

Warning: risk of burnsThe optical fibers emit high-energy light at the distal end of the endoscope. This can cause the temperature of the body tissue to rise to 41 C.

Avoid direct contact of the distal end with body tissue or flammable materials as it can cause burns.

Reduce the light intensity of the cold light source when working near body tissue or flammable materials.

For more information, refer to the Instructions for Use (IFU).

Ordering information

Item number	Description	Units per box
8300057945	TruClear™ hysteroscope duo	1
8300057946	TruClear™ diagnostic sheath duo	1
8300057947	TruClear™ operative sheath duo	1
8300059605	TruClear™ stopcock replacement set, diagnostic (for use with 8300057946)	1
8300059594	TruClear™ threaded ring, duo (for use with 8300057946)	1
8300059604	TruClear™ O-ring duo (for use with 8300057946)	5
8300054627	Polishing paste (for use with 8300057945)	1
8300055246	Rubber replacement seal	1
8300055288	Small stopcock replacement set (for use with 8300057947)	1

Resources

TruClear™ Hysteroscope Set Duo Information Sheet (open in new window)

Get an overview of how the TruClear™ duo helps you expand diagnostic and therapeutic hysteroscopy procedures in your office.

PRODUCT PDF 805 KB

TruClear™ hysteroscope set duo

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TruClear™ hysteroscope set duo

Ordering information

Resources

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United States

Customer Care Team