HFA3 Instructions for Use 2660021166131 Rev. A 2018-11
Go to Contents Introduction
1-7
Instrument Installation
An authorized
ZEISS
service representative or the owner/operator can install the
HFA3
.
In consultation
with the buyer, ZEISS schedules one free on-site installation appointment after instrument delivery.
The owner/operator receives training by Zeiss prior to using the HFA3 instrument for the first time.
System installation and operator training require approximately one-half business day.
Care in Handling
Use extreme care when handling and transporting the HFA3 shipping boxes. The instrument
con
tains fragile optics that have been precisely aligned at the factory.
Installation Requirements
• The HFA3 should be connected to a dedicated power outlet. The HF
A3 will operate within its
specifications when connected to any AC main supply in the range 90 to 264Vac, 47Hz to
63Hz.
• An isolation transformer is required when connecting peripher
al devices that are not Medical
Device approved (for example; printer, USB drive) within 1.5 meters (4.9 feet) away from the
patient, such that the patient cannot touch a peripheral device with any part of his or her body
while being examined.
HFA3 Licenses
Each HFA3 is issued with two Windows
®
operating system licenses: an embedded version and a
consumer version.
Product Compliance
Complies with 93/42/EEC Medical Device Directive.
The product is RoHS-compliant accor
ding to Directive 2011/65/EU.
Product Safety
This instrument is classified as follows:
•
Class I Equipment – Protection against electrical shock.
•
Type B – Degree of protection against electric shock of applied part (chin and forehead rests,
and patient response button).
• Or
dinary Equipment (IPX0) – Degree of protection against ingress of liquids (none).
• Co
ntinuous Operation – Mode of operation.
General Safety Guidelines
Note: Users are not authorized to dismantle or modify the HFA3 hardware. To transport the
instrument outside the office, you must consult with a ZEISS
service technician. Failure to do so
voids all warranties provided with the HFA3.
•
Only ZEISS authorized technicians should disassemble or service this instrument. In the
case of malfunction, error messages or operational problems, call ZEISS Customer Care: In the
U.S., call 800-341-6968. Outside the U.S., contact your local ZEISS distributor.
• This instrument has no special measures to protect against harmful ingress of water or other
liq
uids (classified IPXO—ordinary equipment). Do not place containers of liquid on or near the
instrument, nor use aerosols on or near it.
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