Specification
● 31
Classifications
► Degree of protection (applied part) against electric shock: The device is classified as
of type BF.
►Powering of device: The device is internally powered
► Mode of operation: The device is intended for
CONTINUOUS OPERATION
.
► Degree of protection against ingress of liquids: The device is classified as an ordinary equipment
regarding ingress of liquids, i.e. it is not drip-proof, splash-proof or watertight.
► Use with Flammable Anesthetics: The device is not suitable for use in presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR
or
WITH OXYGEN
or
NITROUS
OXIDE
.
► Installation/use of device: The device is classified as a portable device.
Certifications
The Nox T3 device complies with the following directives and standards:
► Annex V of the
Medical Device Directive 93/42/EEC
and is certified by BSI
to carry the CE label
►
IEC 60601-1
Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
►
UL 60601-
1 Medical Electrical Equipment, - Part 1: General Requirements for Safety (USA)
►
CAN/CSA C22.2 NO. 601.1 - M90
Medical Electrical Equipment - Part 1: General Requirements
for Safety (Canada)
►
IEC 60601-1-2
Medical electrical equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and test
►
IEC 60601-1-4
Medical electrical equipment - Part 1-4: General requirements for safety -
Collateral Standard: Programmable electrical medical systems
►
IEC 60601- 2-25
Particular requirements for the safety of electrocardiographs
►
IEC 60601- 2-26
Particular requirements for the safety of electroencephalographs
►
IEC 60601- 2-40
Particular requirements for the safety of electromyographs and evoked response
equipment
►
ISO 14971
Medical devices - Application of risk management to medical devices
►
ISO 13485
Medical devices – Quality Management systems – Requirements for regulatory
purposes. The manufacturing site of the Nox T3 device is certified according to ISO 13485.
►
EN 300 328
Electromagnetic compatibility and Radio Spectrum Matters (ERM); Wideband
Transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using
spread spectrum modulation techniques
►
EN 301 489-17
Electromagnetic compatibility and radio spectrum matters (ERM);
Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 17: Specific
conditions for wideband data and HIPERLAN equipment
►
EN 60950-1
Information technology equipment – Safety - General requirements
►
EN 50371
Generic Standard to Demonstrate the Compliance of Low-Power Electronic and
Electrical Apparatus with the Basic Restrictions Related to Human Exposure to Electromagnetic
Fields (10 MHz–300 GHz) – General Public
►
FCC Part 15
The device has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of FCC Rules.
►
RSS 210 of IC
The device complies with RSS 210 of Industry Canada (IC)
►
RSS-GEN Issue 1
The device complies with RSS-GEN Issue 1 of Industry Canada (IC)
►
Bluetooth®
compliance
