Canon CF-1 - Manual (Page 61)

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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