Topcon SP-1P, User Manual

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GENERAL INFORMATION ON USAGE AND MAINTENANCE
GENERAL INFORMATION ON USAGE AND MAINTENANCE
INTENDED PATIENT POPULATION
The patient who undergoes an examination by this instrument must maintain concentration for a few
minutes and keep to the following instructions:
• To fix the face to the chinrest, forehead rest.
• To keep the eye open.
• To understand and follow instructions when undergoing an examination.
INTENDED USER PROFILE
Since the Specular Microscope SP-1P is a medical device, the operation should be supervised by a
physician.
ENVIRONMENTAL CONDITIONS OF USE
Temperature: 10°C to 40°C
Humidity: 30% to 90% RH(without condensation)
Atmospheric pressure: 700hPa to 1060hPa
STORAGE, USAGE PERIOD
1. Environmental conditions (without package)
*Temperature : 10°C to 40°C
Humidity
: 10% to 95% (without condensation)
Air pressure : 700hPa to 1060hPa
* THIS INSTRUMENT DOES NOT MEET THE TEMPERATURE REQUIREMENTS OF ISO
15004-1 FOR STORAGE. DO NOT STORE THIS INSTRUMENT IN CONDITIONS WHERE
THE TEMPERATURE MAY RISE ABOVE 40°C OR FALL BELOW 10°C.
2. When storing the instrument, ensure that the following conditions are met:
(1) The instrument must not be splashed with water.
(2) Store the instrument away from environments where air pressure, temperature, humidity,
ventilation, sunlight, dust, salty/sulfurous air, etc. could cause damage.
(3) Do not store or transport the instrument on a slanted or uneven surface or in an area
where it is subject to vibrations or instability.
(4) Do not store the instrument where chemicals are stored or gas is generated.
3. Normal life span of the instrument:
8 years from delivery providing regular maintenance is performed [TOPCON data]
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE
(Product in its normal transport and storage container as provided by manufacturer)
Temperature
: -20°C to 50°C
Humidity : 10% to 95%