grado RM355, Инструкция по эксплуатации

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ENGLISH 17
EC REP
0197
S N
IIa Class Medical Device
According to Directive 93/42/EEC and further modifications
1. CODE
RM355 - Infrared ear thermometer
2. INTRODUCTION
Thank you for purchasing a GRADO a by Moretti Thermometer. This user’s manual provides some suggestions as how
to correctly use the product you have chosen and gives some valuable advice for your safety. Please read through the
manual carefully before using the product. Should you have any queries, please contact your retailer for advice and
assistance. In case of doubts, we recommend to contact the dealer who can help and advice you properly.
3. INTENDED USE
The thermometer is a device designed to measure body temperature via eardrum.
CAUTION!
• Do not use the product for a purpose not indicated in this manual.
• Moretti S.p.A declines all responsibilities for any consequences resulting from an incorrect use
of this product and from unauthorized alteration to the frame of the product.
• The manufacturer reserves the right to change the information contained in this document
without previous notice.
4. DECLARATION OF CONFORMITY
Moretti S.p.A. declares under his sole responsibility that the product placed in the market by the same Moretti
S.p.A. is in conformity to the relevant provisions of Directive 93/42/CEE on medical devices and subsequent
amendments and are produced by Hangzhou Sejoy Electronics & Instruments Co. Ltd according to the standards
indicated in the regulations:
• CEI 60601-1 - Part 1: General requirements for basic safety and essential performance
• EN 60601-1-2 - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility
• ISO 80601-2-56:2009:Medical electrical device - (Part 2-56: Particular requirements for basic safety
and essential performance of clinical thermometers for measuring body temperature).
• The manufacturer is ISO 9001and ISO 13485 certified.
5. GENERAL WARNINGS
• Read instructions thoroughly prior to use.
• Store and use thermometer away from mobile phones.
• Always take temperature readings from the same ear, as ears may differ in temperature.
• Keep the battery away from children.
• Keep the unit dry and away from any liquids and direct sunlight.
• Infrared thermometers should not be used shortly after exercise, bathing or coming indoors.
• Choking Hazard: Thermometer cap and battery may be fatal if swallowed.
Do not allow children to use this device without parental supervision.
• Do not store or keep in direct sunlight, or in high temperature (below -25°C/-13°F or over 55°C /131°F)
non excessive humidity (>95%RH). The packaging is made in paper.
• Shelf life - the thermometer use limit is defined by the wear of the parts.
• Do not place thermometer battery near extreme heat as it may explode.
• Do not allow children to play on or operate the thermometer.
• It is recommended the performance should be checked every two years.
• Remove battery from the device when not in operation for a long time.
• The use of temperature readings for 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.