Product Specifications - Braun ThermoScan IRT 6020 Manual De Instrucciones

Product specifications

Displayed temperature range:
Operating ambient temperature range:
Display resolution:
Accuracy for displayed temperature range
95 °F – 107.6 °F (35 °C – 42 °C):
outside this range:
clinical repeatability:
Long term storage ranges
Storage/transport temperature:
Reference body site:
Humidity:
Battery life:
Service life:
This thermometer is specified to operate at a pressure of 1 atmosphere (700-1060hPA) or at altitudes with
an atmospheric pressure up to 1 atmosphere (700-1060hPA).
Type BF Consult Instructions
Applied Part for Use
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 affect MEDICAL ELECTRICAL EQUIPMENT.
10
93.2 – 108 °F
50 – 104 °F
0.1 °F or °C
Maximum Laboratory Error
± 0.4 °F
± 0.5 °F
± 0.26 °F
-13 °F to 131 °F
Oral equivalent
15-95% non-condensing
10-95% operating; 15-95% storage
2 years / 350 measurements
5 years
104 °F
50 °F
(40 °C)
(10 °C)
Operating Keep dry
temperature Accompanying Documents
-13 °F
(-25 °C)
Lot Serial
Number Number temperature
(34 – 42.2 °C)
(10 – 40 °C)
± 0.2 °C
± 0.3 °C
± 0.14 °C
(-25 °C to 55 °C)
Storage relative
Attention, consult
humidity
131 °F
(55 °C)
Storage Manufacturer
Manufacture
Operating relative
humidity
2
Date of Hygienic lens filter:
Do not reuse