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New Product Information Sheet
Sales Name:
Item Number:
General Information
Sales name and Item number of product
Model/Category of the product
Legal Manufacturer, Production Facilities
Photo of Product
Packaging Content (including accessories)
List of Harmonized EN standards`
Intended Use
Particularity's
How it works
Efficiency of the medial product
Description of the design and test procedure (Application)
Warnings
Specifications
Materials Used
Title page of Instruction Manual
Packages Design
Operation and Care / Storage / Servicing / Repair
Disposal / Warranty / Lifetime
Comparison with Previous Product / Comparative Table
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Gentle Temp 521
MC-521-E
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OMRON HEALTHCARE EUROPE B.V.
Scorpius 33 2132 LR Hoofddorp The Netherlands
P.O. Box 2050 2130 GL Hoofddorp The Netherlands
Phone: +31 (0)23 55 44 700 fax +31 (0)23 55 44 701
www.omron.healthcare.com
BANKERS BANK OF TOKYO-MITUSBISHI (HOLLAND) N.V.
ACC. NR. 063.56.15.320 IBAN NL95BOTK0635615320
SWIFT BOTKNL2X
CHAMBER OF COMMERCE NR. 342.10306
BTW/VAT NR. NL8132.86.281.B01
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Summary of Contents for Omron MC-521-E
- Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Sales Name: Gentle Temp 521 Item Number: MC-521-E Table of Contents Page General Information Sales name and Item number of product Model/Category of the product Legal Manufacturer, Production Facilities...
- Page 2 Phone/Fax: +31 23 5544700 / +31 23 5544 701 e-mail: info@omronhealthcare@eu.omron.com Ear Thermometer Omron Gentle Temp 521 is a medical device meant for measurement of temperature. The thermometer detects the infrared heat given off by the eardrum and surrounding tissues, and it converts this heat into an equivalent ear temperature.
- Page 3 The manufacturer produces the ear thermometer Omron Gentle Temp 521 with the applicable accessories included, necessary for the application of its intended purpose. 1. Main unit 2. Instruction manual 3. Test battery 4. Probe cap 5. 21 Probe covers 6. Connection Ring 7.
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Page 4: Intended Use
Intended Use of the Probe Covers Medical product’s intended use as determined by the manufacturer. The probe cover is designed to be used on the Omron Gentle Temp 520 digital ear thermometer. It protects the sensor from dirt and ear wax to ensure accurate measurements. - Page 5 Particularities OMRON is introducing the Gentle Temp 521 ear thermometer. It uses a highly accurate technology and includes some of its advanced features, including one- second measurement, selectable centigrade/Fahrenheit readings and a memory for up to 25 readings. It also comes with 21 probe covers. OMRON recommends changing the covers each time to ensure good hygiene and the most accurate measurements.
- Page 6 Description of the design and test procedure Infrared Sensor Probe Probe cap Probe cover detector Display ON/MEM button Battery cover pick hole Battery compartment Connection ring Probe cover Application: Review the Instruction Manual for the full details on the application of this product. 1.
- Page 7 Warnings • Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. • Conducting self-diagnosis based on the measurement results and/or treatment can be dangerous. Please follow the instructions of your doctor. Self-diagnosis may worsen the symptoms.
- Page 8 • Do not disassemble, repair, or modify the unit. • When you inform your doctor of your temperature, make sure you state that you measured the temperature in the ear. Specifications of OMRON Gentle Temp 521 (MC-521-E) Product Description: Digital Ear Thermometer...
- Page 9 Materials Used Component Material Polycarbonates Plastic Battery Cover Acrylonitrile - Butadiene - Styrene Plastic Cosmetic cover Acrylonitrile - Butadiene - Styrene Plastic Rear Cover Acrylonitrile - Butadiene - Styrene Plastic Action Key Polypropylene Plastic Front Cover Acrylonitrile - Butadiene - Styrene Plastic Power Button Silicone Rubber Probe cover...
- Page 10 Title page of Instruction Manual (9 languages – English / French / German / Italian / Spanish / Dutch / Russian / Turkish / Arabic PM-1157-01-07/2013...
- Page 11 OMRON Gentle Temp 521 (MC-521-E) Package Design Packaging specifications Dimensions WxDxH Weight 36x56x161mm Main Unit 115x59.5x197mm 343g Package 497x420x340 15KG Master Carton PM-1157-01-07/2013...
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Page 12: Operation And Care
The device requires no routine service other than cleaning, and visually checking for damage. Repair In case of malfunction of the device the user must turn to the OMRON retail outlet or distributor to test the device and repair the failure. The user shall not repair the device by themselves. - Page 13 Warranty term for probe cover – None as this is a single use item. Lifetime Lifetime of the ear thermometer. 5 years Life of the probe cover: no lifetime as these are considered disposable items Warranty terms are specified in the warranty card inside the packaging of the Omron Gentle Temp 521. PM-1157-01-07/2013...
- Page 14 Comparison with Previous Product The Gentle Temp 521 (MC-521-E) with the legal manufacturer of OMRON HEALTHCARE Co., Ltd at the production location of Radiant No. 20, TaiHongRoad, WuSong Jiang Development Zone, YuShan Town, KunShan City, Jiang Su, China, is an substantially equivalent to a similar device MC-510-E2.
- Page 15 Measurement 34.0C (93.2F) to 42.2C (108.0F) 34.0C (93.2F) to 42.2C (108.0F) Range: Power Supply: 3.0V DC, 1 CR2032 Lithium Button 3.0V DC, 1 CR2032 Lithium Button Battery Battery Power 0.015 W 0.05W Consumption Battery Life With a new battery approx. 2,500 With a new battery approx.
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