Omron MC-521-E Product Information Sheet

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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 1
Model/Category of the product 1
Legal Manufacturer, Production Facilities 1
Photo of Product 1
Packaging Content (including accessories) 2

List of Harmonized EN standards` 2

Intended Use 3

Particularity’s

How it works 4
Efficiency of the medial product 5
Description of the design and test procedure (Application) 6

Warnings 7-8

Specifications 8

Materials Used 9

Title page of Instruction Manual 10

Packages Design 11

Operation and Care / Storage / Servicing / Repair 12

Disposal / Warranty / Lifetime 13

Comparison with Previous Product / Comparative Table 14-15

OMRON HEALTHCARE EUROPE B.V.

Scorpius 33 2132 LR Hoofddorp The Netherlands

P.O. Box 2050 2130 GL Hoofddorp The Netherlands

Phone: [phone] fax [phone]

BANKERS BANK OF TOKYO-MITUSBISHI (HOLLAND ) N.V.

ACC. NR. 063.56.15.320 IBAN NL95BOTK0635615320

CHAMBER OF COMMERCE NR. 342.10306

www.omron.healthcare.com

SWIFT BOTKNL 2

BTW/VAT NR. NL8132.86.281.B 01

Infrared Ear Thermometer

Omron Gentle Temp 521 (MC-521-E)

LEGAL MANUFACTURER

Address:
OMRON HEALTHCARE Co., Ltd
53, Kunotsubo, Terado-cho, Muko, Kyoto
617-0002 Japan
Phone/Fax: [phone]
e-mail: info@[e-mail]

PRODUCION FACILITIES

Address:
Radiant Innovation Inc.
No. 20, TaiHongRoad, WuSong Jiang Development Zone
YuShan Town, KunShan City, Jiang Su, China
Phone/Fax: [phone]
e-mail: info@[e-mail]

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. The Gentle Temp 521 also measures the surface temperature of
an item for example baby’s milk. The device also shows the room temperature when
turned on.

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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. Warranty card

The complete set of the medical device is specified in the Instruction Manual in the
Technical Data section

The above mentioned medical device belongs to a IIa (MDD Annex IX Rule 10)
potential risk class.

Applicable Directives: Medical Device Directive (MDD) 93/42/EEC

Standards: EN980:2008
EN1041:2008
EN60601-1:2006
EN60601-1-2:2007
EN60601-1-6:2007
EN ISO14971:2012
EN ISO 10993-1:2009
EN ISO 10993-5:2009
EN ISO 10993-10:2010
EN62304:2006
EN62366:2008
EN12470-5:2003

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Intended Use

Medical product’s intended use as determined by the manufacturer.

The device is a digital ear thermometer to measure the infrared heat given off by the
eardrum and surrounding tissues, and converts this heat into an equivalent ear
temperature.

Application field:

This device is designed for use in a physician’s office, hospitals, clinics and other
medical facilities as well as home use.

User:

This device may be used by a medical professional or adult on themselves or
children. The device is intended for use on adults and children as well as babies.

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.

Application field:

This device is designed for use in a physician’s office, hospitals, clinics and other
medical facilities as well as home use.

User:

This device may be used by a medical professional or adult on themselves or
children. The device is intended for use on adults and children as well as babies.

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Particularities

OMRON is introducing the Gentle Temp 521 ear thermometer. It uses a highly
accurate technology and includes some of its advanced features, including one­second 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. To assist with readings in the dark (on a ward or in a child’s room at
night) the device also has backlight function. The 3 in 1 function enables various
types of measurement, ear, surface and room temperature.

The Gentle Temp 521 is a supplement to our current EFT portfolio.

Key features:

 3 in 1 measurement (ear, surface, room temp. measurement)

 Fast 1 second measurement

 25 memories
 Backlight function
 21 probe covers
 Selectable Celsius/Fahrenheit
 New ergonomic design
 Large display
 Automatic shut-off

The digital ear thermometer Omron Gentle Temp 521 measures the infrared heat
given off by the eardrum and surrounding tissues, and converts this heat into an
equivalent ear temperature. For surface and room temperature the device measures
the infrared heat given off by the air or surface.

Efficient measurement of the body temperature is one of the most important element
of disease control. The device allows the care giver to easily and accurately
measure the patient’s body temperature. The infrared method is used for detecting
the temperature.

How it works

Efficiency of the medical produc t

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