Braun ThermoScan IRT 6020 - Product specifications; Accuracy and Operating Ranges; Battery Life and Service Life; Standards Conformance and EMC

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Product specications
Displayed temperature range: 93.2 – 108 °F (34 – 42.2 °C)
Operating ambient temperature range: 50 – 104 °F (10 – 40 °C)
Display resolution: 0.1 °F or °C
Accuracy for displayed temperature range Maximum Laboratory Error
95 °F – 107.6 °F (35 °C – 42 °C): ± 0.4 °F ± 0.2 °C
outside this range: ± 0.5 °F ± 0.3 °C
clinical repeatability: ± 0.26 °F ± 0.14 °C
Long term storage ranges
Storage/transport temperature: -13 °F to 131 °F (-25 °C to 55 °C)
Reference body site: Oral equivalent
Humidity: 15-95% non-condensing
10-95% operating; 15-95% storage
Battery life: 2 years / 350 measurements
Service life: 5 years
This thermometer is specied to operate at a pressure of 1 atmosphere (700-1060hPA) or at altitudes with
an atmospheric pressure up to 1 atmosphere (700-1060hPA).
Subject to change without notice.
This appliance conforms to the following standards:
This infrared thermometer meets requirements established in ASTM Standard (E 1965-98) as it pertains to
infrared thermometers. Full responsibility for the conformance of this product to the standard is assumed by
Kaz USA, Inc. ASTM laboratory accuracy requirements in the display range of 98 to 102 °F (37 to 39 °C) for IR
thermometers is +0.4 °F (+0.2 °C), whereas for mercury in- glass and electronic thermometers, the
requirement per ASTM Standards E 667-86 and E 1112-86 is +0.2 °F (+0.1°C).
EN ISO 80601-2-56: Medical electrical equipment – Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body temperature measurement.
EN IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
EN ISO 14971: Medical devices – Application of risk management to medical devices.
EN ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process.
EN IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.
EN ISO 15223-1: Medical devices. Symbols to be used with medical device labels, labelling and information
to be supplied. Part 1: General requirements.
EN IEC 60601-1-11: Medical electrical equipment – Part 1-11: General requirements for basic safety and
essential performance – Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment.
This product conforms to the provisions of the EC directive 93/42/EEC.
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description of
EMC requirements please contact Customer Service.
Portable and mobile RF communications equipment can aect MEDICAL ELECTRICAL EQUIPMENT.
Attention, consult
Accompanying Documents
Type BF
Applied Part
Operating
temperature
Keep dry
Serial
Number
Lot
Number
Consult Instructions
for Use
50 °F
(10 °C)
104 °F
(40 °C)
Storage relative
humidity
Operating relative
humidity
Hygienic lens lter:
Do not reuse
Manufacturer Date of
Manufacture
2
Storage
temperature
-13 °F
(-25 °C)
131 °F
(55 °C)