Ametek Reichert Tono-Vera Vet Instructions For Use Manual page 26

Specifications
(continued)
Device Regulatory Classification
Insulation Protection: Internally Powered (6 V battery)
Ingress Protection: IPX0
Applied Part Type: BF
Operation Mode: Continuous
Compliance
Tono-Vera Vet complies with:
IEC 60601-1:2005 + A1:2012 (Edition 3.1)
IEC 60601-1-2:2014 (Edition 4)
The LMX9838 has been tested and approved to be compliant to the following regulatory standards:
CE Compliance
IEC 60601-1 Edition 3.1
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 Edition 3.1
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance – Collateral Standard:
Usability
IEC 60601-1-2 Edition 4.0
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance – Collateral Standard:
Electromagnetic disturbances – Requirements and tests
CISPR 11
Industrial, scientific and medical equipment –
Radio-frequency disturbance characteristics – Limits and methods of measurement
IEC/EN 61000-3-2
Electromagnetic compatibility (EMC) –
Part 3-2: Limits – Limits for harmonic current emissions (equipment ≤ 16A per phase)
IEC/EN 61000-3-3
Electromagnetic compatibility (EMC) –
Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage
supply systems, for equipment with rated current ≤ 16A per phase and not subject to conditional
connection
Radio Equipment Directive (RED) 2014/53/EU
ETSI EN 300 328:2016 Ed. V2.1.1
Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and
using wide band modulation techniques; Harmonized Standard covering the essential requirements of
article 3.2 of Directive 2014/53/EU
ETSI EN 301 489-1:2019-11 Ed. V2.2.3
Electromagnetic Compatibility (EMC) standard for radio equipment and services;
Part 1: Common technical requirements; Harmonized Standard for Electromagnetic Compatibility
ETSI EN 301 489-17:2017-03 Ed. V3.2.2
Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific
conditions for Broadband Data Transmission Systems; Harmonized Standard for Electromagnetic
Compatibility
AS/NZS 4268:2017
Radio equipment and systems –
Short range devices – Limits and methods of measurement
Method of compliance per standard above and RSS-Gen
FCC Compliance
FCC 47 CFR Part 15 Subpart B – Class B Digital Device – Unintentional Radiators
FCC 47 CFR Part 15 Subpart C 15.247 Operation within the bands 902-928 MHz, 2400-2483.5 MHz, 5725-
5850 MHz
(Approved Module Spurious Emission Verification)
ANSI C63.4:2014
American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage
Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz
IC (INDUSTRY CANADA):
ISED ICES-003:2016 Ed. 6
ISED ICES-003, Issue 6, Class A – Information Technology Equipment (Including Digital Apparatus) –
Limits and methods of measurement
Compliance is suggested by ISED Canada as CAN ICES-3 (A) / NMB-3 (A)
Method of compliance per each standard above and ANSI C63.4:2014
MIC Japan Compliance
Low power data communications in the 2.4GHz band - Radio Equipment
Radio Law: Law No. 131, 1950 and Amendments
Standards: MIC Notification No. 88 Annex 43
Certificate No: JN0834 i02
16308-101 Rev. A • 26