Self-Diagnostics SD-T Flex 120 Manual Del Propietário

INSTANT FLEXIBLE DIGITAL THERMOMETER
EN
OWNER'S MANUAL
! WARNING
• Read instructions thoroughly before using digital thermometer.
• Choking hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children to use this
device without parental supervision.
• Do not use thermometer in ear. Thermometer is designed for oral, rectal and armpit (axilla) readings only.
• Do not place thermometer battery near extreme heat as it may explode.
• Remove battery from the device when not in operation for a long time.
• The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the interpretation of
results. Self-diagnosis may lead to the worsening of existing disease conditions.
• Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
• Do not bite the thermometer. Doing so may lead to breakage and/or injury.
• Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.
• After each use, disinfect the thermometer, especially if the device is used by more than one person.
• Do not force the thermometer into the rectum. Stop insertion and abort the measurement if pain is present.
Failure to do so may lead to injury.
• Do not use thermometer orally after it has been used rectally.
• For children who are two years old or younger, please do not use the device orally.
• If the unit has been stored at temperatures over 5°C-40°C (41°F-104°F), leave it at a 5°C-40°C (41°F-104°F) ambi-
ent temperature for about 15 minutes before using it.
INDICATIONS FOR USE
This digital thermometer is intended to measure human body temperature in regular mode orally, rectally or
under the arm. The device is reusable for clinical or home use on people of all ages, including children under 8
years old with adult supervision.
PLEASE READ CAREFULLY BEFORE USING
This digital thermometer provides a quick and highly accurate reading of an individual's body temperature. To
better understand its functions and to provide years of dependable results, please read all instructions first.
This appliance conforms to the following standards: EN 12470-3 Clinical thermometers —Part 3: Performance of
compact electrical thermometers (non-predictive and predictive) with maximum device, 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 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. It complies with
the requirements of EN 60601-1-2(EMC), IEC/EN60601-1(Safety) standards. The manufacturer is ISO 13485
certified.
CONTENTS
1 thermometer, 1 owner's manual, 1 storage case
PRODUCT ILLUSTRATION
Figure 1
probe
PRECAUTIONS
• The performance of the device may be degraded should one or more of the following occur:
̵ Operation outside the manufacturer's stated temperature and humidity range.
! ̵ Storage outside the manufacturer's stated temperature and humidity range.
̵ Mechanical shock (for example, dropping the device) or degraded sensor.
̵ Patient temperature is below ambient temperature.
• Portable and mobile RF communications can affect the device. Special precautions must be taken
regarding EMC. Refer to the EMC information provided in the accompanying documents.
SYMBOL EXPLANATION
Direct Current
Type BF Applied Part
Consult instructions for use
EC REP European Authorized Representative
SPECIFICATIONS
Type
Measurement range
Accuracy
Operating mode
Display
Memory
Battery
Battery life
Dimensions
Weight
Expected service life
Ambient operating range
Storage and transporta-
tion conditions
Ingress Protection Rating
Classification
Digital thermometer (not predictive)
32.0°C-42.9°C (90.0°F-109.9°F)(°C/°F chosen by manufacturer)
±0.1°C (±0.2°F) for 35.5°C-42.0°C (95.9°F-107.6°F) at 18°C-28°C (64.4°F-82.4°F ) ambient
operating range; ±0.2°C (±0.4°F) for other measuring and ambient operating ranges
Direct mode
Liquid crystal display, 3 1/2 digits
For storing the last measured value
One 1.5 V DC button battery (size LR41 or SR41, UCC 392)
Approx. 200 hours of continuous operation or 1 year with 3 measurements per day
13.9 cm x 2.3 cm x 1.3 cm (L x W x H)
Approx. 13 grams including battery
Three years
Temperature: 5°C-40°C (41°F-104°F)
Relative humidity: 15%-95% RH
Atmospheric pressure: 700 hPa - 1060 hPa
Temperature: -20°C-55°C (-4°F-131°F)
Relative humidity: 15%-95% RH
Atmospheric pressure: 700 hPa - 1060 hPa
IP 27
Type BF
LCD
on/off
Batch code
Manufacturer
55°C
Storage and transportation temperature
limit: -20°C-55°C (-4°F-131°F)
-20°C
battery cap
button