Gilras GRU-5000 A, Operation Manual

Page: 8 / 68

Caution
- VI -
CAUTIONS
HOW TO PREVENT CROSS-INFECTION
 It is prohibited to use the device on patients with eye trauma, inflammation or infection.
 Between uses on different patients, the probe and eye cup must be thoroughly cleaned and
disinfected to prevent cross-infection.
 The Manufacturer advocates a preventive action and a cleaning procedure in Chapter 5.
Cleaning, Disinfection and Sterilization.
____________________
CAUTION
 Federal (US) Law restricts this device to sale by or on the order of a physician.
 The GRU-5000 IOL calculator will calculate negative IOL values if such is predicted by the
data input.
 These are displayed with a minus sign "-". Do not ignore this sign.
_____________________
TISSUE EXPOSURE TO ULTRASOUND ENERGY:
 The GRU-5000 is designed for use in ophthalmology only.
 While the manufacturer is not aware of any reports of adverse effects from using ophthalmic
ultrasound scanner, even at FDA pre-enactment levels, no other use is intended or implied.
 The system controls limit of the output energy within the parameters specified for its intended
purpose. Please refer to Annex A of the
User Manual
.
 No control of ultrasound energy is available to the users other than the duration of exposure,
considering the current concern for possible unknown hazards, and despite the extremely low
output intensities used in this ultrasound system.
 The manufacturer recommends that patients’ exposure time during measurement be
minimized.