Chapter 8 - Technical Specification
9 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 page11).
If you have any questions regarding the correct use of your device, please contact your Optos
representative (see Contact us on page79).
9.1 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) (see Guidance and manufacturer declaration – electromagnetic
emissions on page74).
Operation is subject to the following two conditions:
1. This device may NOT cause harmful interference.
2. This device MUST accept any interference received, including interference that may cause undesired
operation.
9.1.1 Scan head
TABLE 10: Scan head safety designation details
Feature description Compliance
Type of protection against electrical shock Class 1
Degree of protection against electrical shock
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.
Applied parts Forehead pad, chin pad and face pad
Degree of electrical connection between
equipment and patient
The equipment is designed as a non-electrical
connection to the patient.
Degree of mobility Transportable
Mode of operation Continuous
Device type Medical
Supply connection 100 to 240Vac, 50/60Hz, (IEC60601-1)
Electrical Protection T5A H250V (5 mm x 20 mm)
Part Number: G110230-003-ENG Page 69 of 84
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