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1.
IMPORTANT NOTICE
1.1
Intended Use
The Auto Refractor/Keratometer
ERK-9200
is used to determine the initial, objective
refractive values for a patient’s eye in the workflow of refraction to determine the optical
prescriptions for myopia, hyperopia and astigmatism.
1.2
Classifications
Classification under the provision of 21 CFR)] ClassI
The ERK-5400A is classified as Class
I
device
[Form of protection against electric shock] Class
Ⅰ
The ERK-9200 is classified as Class I.
This product is always protected when you connect the power supply must be
connected to ground included. Class I is a product in which the protection against
electric shock does not rely on basic insulation only, but which includes an additional
safety precaution in such a way that means are provided for the connection of the
product to the protective (ground) conductor in the fixed wiring of the installation in such
a way that accessible metal parts cannot become live in the event of a failure in the
basic insulation. Use a power outlet which is equipped with a grounding terminal.
[Degree of protection against electric shock] Type B Applied Part
The ERK-9200 is classified as a device with a Type B Applied Part
[Degree of protection against ingress of liquids] IPX0
The ERK-9200 is classified as IPX0
[Degree of protection against flammability]
The ERK-9200 is classified as a device not suitable to be used in a potentially
flammable environment. Do not use near flammable materials
[Method(s) of sterilization or disinfection recommended by the manufacturer]
The forehead rest and chinrest should be wiped using a cloth dampened with soapy
water as necessary
[Mode of operation]
Classification of ERK-9200 : continuous operation
Содержание ERK-9200
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