Product Specifications - Braun ThermoScan 7 Manual

Product specifications

Displayed temperature range:
Operating ambient temperature range:
Storage temperature range:
Storage relative humidity:
Operating relative humidity:
Display resolution:
Accuracy for displayed temperature range
35 – 42 °C (95 – 107.6 °F):
Outside this range:
Clinical repeatability:
Reference Body Site:
Battery life:
Service life:
This thermometer is specified to operate at 1 atmosphere or at altitudes with an atmospheric pressure up to
1 atmosphere (700 - 1060 hPa).
Consult 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 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 compatibility – Requirements and tests.
EN ISO 15223-1: Medical devices. Symbols to be used with medical device labels, labelling and information
to be supplied. 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 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
Storage 15-95% RH (non-condensing)
Operating 10-95%
0.1 °F or °C
Maximum Laboratory Error
±0.4 °F
±0.5 °F
±0.26 °F
Oral Equivalent
2 years in sleep mode / 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)
Attention, consult
Keep dry
accompanying documents
Lot Serial Manufacturer
Number Number
Storage relative Operating relative
humidity humidity
2
Date of Hygienic lens filter:
Manufacture Do not reuse