Introduction; Declaration Of Conformity - marsden UFR103 User Manual

Thank you for purchasing this Marsden UFR103 Non Contact Infrared Thermometer.
This thermometer uses advanced infrared (IR) technology to measure forehead or
object temperature instantly and accurately. To ensure accurate use of the UFR103,
please read this user manual before use and keep to hand for future reference.

Declaration of Conformity

● This product is approved under 93/42/EEC Medical Devices Directive.
● Full responsibility for the conformance of this product to the Standard is
assumed by Shenzhen Urion Technology Co., Ltd, Floor 4-6
D, Jiale Science & Technology Industrial Zone, No.3, ChuangWei Road,
Heshuikou Community, MaTian Street, GuangMing New District, 518106
Shenzen.
Medical electrical equipment -- Part 1-2: General requirements for basic safety and
EN 60601-
essential performance - Collateral standard: Electromagnetic disturbances -
1-2:2015
Requirements and tests
Medical electrical equipment -- Part 1-2: General requirements for basic safety and
IEC 60601-
essential performance - Collateral standard: Electromagnetic disturbances -
1-2:2014
Requirements and tests
Medical electrical equipment – Part 1-11: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for medical electrical
EN 60601-
1-11:2015 equipment and medical electrical systems used in the home healthcare environment
Clause 12 of IEC 60601-1-11
Medical electrical equipment – Part 1-11: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for medical electrical
IEC 60601-
equipment and medical electrical systems used in the home healthcare environment
1-11:2015
Clause 12 of IEC 60601-1-11
Medical electrical equipment —Part 2-56: Particular requirements for basic safety and
ISO 80601-
essential performance of clinical thermometers for body temperature measurement
2-56:2017
Clause 202 of ISO 80601-2-56
This does not guarantee in any way that the device will not be affected by electromagnetic
interference. Avoid using the device in a high electromagnetic environment.
Classification
1. Internally powered equipment;
2. Type BF applied part;
3. Protection against ingress of water or particulate matter: IP20;
4. Not category AP/APG equipment;
5. Mode of operation: Continuous operation.
Note: the user must check that the device functions safely and correctly and ensure
that it is in proper working condition before use.
Floor Building
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