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11. EN IEC60601-1-6:2010
Equipment Application Specification CF-1
1.
Medical Purpose
a) Device name
Retinal camera
b) Objective
Observation, photographing, and recording of the ocular fundus
by passing through the pupil without making contact with the
examined eye and providing fundus image information for
diagnosis.
2.
Patient Group
a) Patient type
Human
b) Age group
Infants to senior citizen
c) Sex Male/female
d) Height No
restriction
e) Weight No
restriction
f) Nationality No
restriction
g) Health status
Various
h) Medical condition
Various (conscious state)
i) Patient’s role
The patient is not the operator.
j) Miscellaneous Patient
contact
with forehead rest and chin rest.
3.
Body Parts, Organs and Tissues
a) Parts Eye
b) Organs and tissues
Ocular fundus (retina, macular region, optic papilla, etc.)
4.
Intended Operator
a) Age
None (someone having satisfied the appropriate educational
and/or qualification level)
b) Sex Male/female
c) Weight No
restriction
d) Educational level
General knowledge of ophthalmology
e) Skills/knowledge
Skills and knowledge to understand the information in the
operation manual. No special training is required.
f) Language ability
Capable of understanding English vocabulary
g) Experience
Guided by an experienced technician many times
h) Disabilities
An operator having the use of both arms and legs is envisioned.
i) Maintenance
Carried out by a trained serviceman.
5.
Environment
a) Location
Examination room. Not intended for outdoor use.
b) Illumination
Lighting environment where the pupil of the examined eye does
not contract
c) Temperature and humidity
10 to 35°C, 30 to 90% RH
6.
Frequency of Use
50 shots per day are envisioned.
7.
Durable Years
8 years
8.
Mobility
Desktop units
9.
Hygiene Maintenance
The forehead rest and chin rest are wiped clean with
disinfecting ethanol.
10. Technology (other devices)
None
000_L-IE-5152E_CF-1.book Page 61 Monday, July 29, 2013 10:30 AM
