J0122

Trade name

not provided

06971244213355

697124421GQJ0001CH

Reference / catalog number

J0122

GS1

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Hysteroscope is used for observation during diagnostic and therapeutic of intrauterine diseases.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 170 MU50
• 6.4 MU50
• 22 MU105
• Field of view — 60 MU105

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12020704HYSTEROSCOPES

4 warnings recorded — scroll inside the panel to see all entries.

• CW275

  Doctors who use hysteroscopy must be specially trained and have the corresponding qualifications and experience. The surgeon must be proficient in hysteroscopy operation techniques and should have relatively mature surgical experience and good professional qualities. Before operating, medical literature on relevant technologies, complications, hazards, etc. should be consulted.
• CW029

  In order to avoid the injury causing from rough surfaces, sharp edges and protrusions, please check the inserting part of the endoscope and its accessories before use.
• CW010

  Please read this instruction manual and the instruction manual of related equipment before use. Incorrect use will cause damage to the device and affect the use.
• CW258

  When the light exit window of the endoscope transmit the high-energy radiation light, the temperature of the light exiting portion may exceed 41 ℃, which will cause the high temperature harm to the front portion of the light exit window, in the premise to meet clinical needs, we propose the operation time as short as possible, the light source brightness as low as possible If the surface temperature of the hysteroscope exceeds 41 ℃, it may cause burns to contact site of the patient, so if the doctor felt clearly the surface temperature of the hysteroscope exceeds body temperature, he should stop using immediately. If the cooling fan or light insulated glass failed, replace it with the standby light source or take other emergency measures quickly.