4.
INFORMING MANUFACTURER AND AUTHORITIES
If a serious incident occurs in connection with this medical device affecting the
operator or another person, the operator (or person responsible) must report this
serious incidence to the manufacturer or seller of the medical product. In the
European Union, the operator must report this serious incident to the responsible
authorities in the applicable country.
5.
DEVICE COMPOSITION
This device consists of
• two pins connector,
• lemo connector,
• wire.
6.
CONNECTION TO OTHER DEVICES
This device can be used only with the following ZEISS
CAUTION!
diathermy probes.
303060 0251 000
DIATHERMY FORCEPS
303060 0252 000
DIATHERMY PENCIL ERASER
7.
INSTRUCTIONS FOR ASSEMBLY AND USE
NOTE!
• This device is designed to be used at medical centers where eye surgery is
performed. Its use is restricted to qualified medical personnel only. Follow
the instructions shown here, taking care not to compromise sterility in the
operating area.
Risks due to the user's level of experience.
CAUTION!
Outcomes from the use of the device can be affected by the user's level of
experience.
• The user should be adequately trained in handling the device prior to its use.
Risk due to non-sterile device.
CAUTION!
• Please follow the instructions for cleaning, disinfecting, and sterilization in the
document "Instruction for reprocessing" prior to first use of the device.
CAUTION!
• The device should not touch the patient or other cables.
CAUTION!
• The device is not intended for continuous operation.
NOTE
• Before and during use, avoid contact with metal objects, particularly if they are
sharp and/or pointed.
3
