Technical Specification; Safety Designation (Iec 60601-1); Scan Head; Table 7: Scan Head Safety Designation Details - Nikon Optos California P200DTx rg Manuel D'utilisation

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 63 .

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 IEC/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 60 .
Operation is subject to the following two conditions:
1. This device may
2. This device
operation.

4.1.1 Scan head

TABLE 7: 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
Degree of mobility
Mode of operation
Device type
Supply connection
Electrical Protection
Part Number: G108025/4GCA
Copyright 2017, Optos plc. All rights reserved.
cause harmful interference.
NOT
accept any interference received, including interference that may cause undesired
MUST
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.
Transportable
Continuous
Medical
100-240Vac, 50/60Hz, (IEC60601-1)
North America 100-120Vac, 50/60Hz, (AAMI-ES60601-1
2005)
T5A H250V (5 mm x 20 mm)
Chapter 4 - Technical Specification
Page 55 of 69
English