Essilor MYOPIA EXPERT 700, Руководство пользователя

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16
4.5 I
NSTALLATION WITH
E
XTERNAL
D
EVICE OR
I
T
N
ETWORK
MYOPIA EXPERT 700 complies with the CE marking requirements.
•
External equipment intended for connection to signal inputs/outputs on the Medical Electrical
Equipment shall comply with the relevant product standard for such equipment, e.g., IEC 60950-
1 or IEC 62368-1 for IT-equipment and the IEC 60601 for Medical Electrical Equipment. In
addition, all such combinations
–
Medical Electrical Systems
–
shall comply with the requirements
stated in clause 16 of IEC 60601-1. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient environment i.e., at least 1.5 m
from the patient support or shall be supplied via a Separation transformer to reduce the leakage
current.
Any person who connects external equipment to the Medical Electrical Equipment has formed a
Medical Electrical System and is therefore responsible for the system to comply with the
requirements set in clause 16 of IEC 60601-1. If in doubt, contact a qualified medical technician
or your local representative.
A Separation Device (isolation device) is needed to isolate the equipment located outside the
patient environment from the equipment located inside the patient environment. In particular,
such a Separation Device is required when a network connection is made. The requirement for
the Separation Device is defined in clause 16.5 of IEC 60601-1.
In case a Multiple Socket Outlet is used to supply the system, a Medical Electrical System has
been created, even if there is no signal connection to other equipment. This might lead to an
increase in leakage current and grounding impedances. Therefore, a Multiple Socket Outlet should
always be used with an isolation transformer, as described in clause 16.9 of IEC 60601-1.
Note that the total grounding impedance, from each equipment in a system, should be maximum
0.2 Ohm measured to the grounding pin in the mains plug of the Multiple Socket Outlet.
•
An external keyboard or another input device compatible with USB interfaces such as barcode or
card readers can be connected to the device to enter text.
•
Do not use mobile phones or other devices not compliant with the requirements of class B EMC
near the MYOPIA EXPERT 700.
•
Every external device that has to be connected to MYOPIA EXPERT 700 must have a USB
connection cable with a maximum length of 3 m.
•
The purpose of the MYOPIA EXPERT 700 connection to an IT network is to print reports and perform
remote technical assistance.
•
The MYOPIA EXPERT 700 USB port must be connected to the printer with a USB or LAN interface.
Ask the local distributor technical assistance for printer driver installation.
•
The MYOPIA EXPERT 700 can be connected to a Local Area Network (LAN) through the LAN
connector. The network must have an Ethernet protocol (IEEE 802.3). Ask your local distributor
for technical assistance and the MYOPIA EXPERT 700 system administrator for network settings.