Product Specifications - Braun ThermoScan IRT 6515 Manual Del Usuario

Product specifications

Displayed temperature range:
Operating ambient temperature range:
Storage temperature range:
Operating and storage relative humidity:
Display resolution:
Accuracy for displayed temperature range
35 – 42 °C (95 – 107.6 °F):
Outside this range:
Clinical repeatability:
Reference Body Site: Oral Equivalent
Battery life:
Service life:
Clinical accuracy characteristics and calibration procedures are available upon request.
This thermometer is specified to operate at a pressure of 1 atmosphere or at altitudes with an atmospheric
pressure up to 1 atmosphere. (700 - 1060 hPa).
See Instructions for use
Type BF Applied Part
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 37 to 39 °C (98 to 102 °F) for IR
thermometers is +/- 0.2 °C (+/- 0.4 °F), whereas for mercury-in-glass and electronic thermometers, the
requirement per ASTM Standards E667-86 and E1112-86 is +/- 0.1°C (+/- 0.2 °F).
Standard Reference Edition Title:
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.
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
ISO 14971: Medical devices – Application of risk management to medical devices.
ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process.
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.
ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labelling and information to
be supplied - Part 1: General requirements.
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.
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description of
EMC requirements please contact your authorized local Service Center (See guarantee card).
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
Please do not dispose of the product in the household waste at the end of its useful life.
To protect the environment, dispose of empty batteries at appropriate collection sites according to
national or local regulations.
10
93.2 – 108 °F
50 – 104 °F
-13 – 131 °F
10-95% RH (non condensing)
0.1 °F or °C
Maximum Laboratory Error
±0.4 °F
±0.5 °F
±0.26 °F
2 years / 350 measurements
5 years
40 °C
10 °C
Operating temperature Storage temperature
(34 – 42.2 °C)
(10 – 40 °C)
(-25 – 55 °C)
(±0.2 °C)
(±0.3 °C)
(±0.14 °C)
Keep it dry
Attention, consult
accompanying documents