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4 Technical Specification
Your device is a medical device and, as such, should be operated within the technical parameters and
instructions defined in this User Guide. Read the warnings and cautions before using your device, see
Warnings and cautions on page 11.
If you have any questions regarding the correct use of your device, please contact your Optos representative,
see Contact us on page 55.
4.1 Safety designation (IEC 60601-1)
In order to provide reasonable interference protection against radio communication services, this device has
been tested and complies with 47 CFR Part 15, Sub Part B of the FCC (U.S.A.) rules and EN 60601-1-2
standard requirements at the premises of a typical user, and the CISPR11 standard emission limits
(CISPR11 Group 1 Class B), Guidance and manufacturer declaration - electromagnetic emissions on
page 51.
Operation is subject to the following two conditions:
1. This device may
NOT
2. This device
accept any interference received, including interference that may cause undesired
MUST
operation.
4.1.1 Scan head
TABLE 6: Scan head safety designation details
Feature description
Type of protection against electrical shock
Degree of protection against electrical shock
Degree of electrical connection between
equipment and patient
Applied parts
Degree of mobility
Mode of operation
Device type
Supply connection
Electrical Protection
Part Number: G102748/11_ENG
Copyright 2021, Optos plc. All rights reserved.
cause harmful interference.
Compliance
Class 1
Type B applied part
Type B - relates to the allowable maximum leakage
current which can flow from the applied part. The limits for
this are defined in IEC/EN 60601.
The equipment is designed as a non-electrical connection
to the patient.
Face pad and eye piece.
Transportable
Continuous
Medical
100-240Vac, 50/60Hz, (IEC60601-1)
North America 100-120Vac, 50/60Hz, (UL60601-1)
T3.15A H250V (5 mm x 20 mm)
Chapter 4 - Technical Specification
Page 47 of 60
English
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