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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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. Chose which temperature indication (°C and °F)

2. Set the buzzer (to turn the buzzer on or off)

3. Attach the probe cover

4. Press ON/MEM button

5. Insert probe comfortably into the ear in the direction of the eardrum

6. Press START button

7. At the long beep, the thermometer can be removed

8. Read the temperature measurement

9. Press and hold ON/MEM button to shut off

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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.

• A high or prolonged fever requires medical attention, especially for small children. Please
contact your doctor.

• Please keep still during measurement.

• Do not forcibly insert the probe in the ear.

• If you feel discomfort such as a pain during the measurement, stop using the unit
immediately. It may injure the external auditory canal.

• Do not use this unit if suffering from ear disease such as otitis externa or otitis media. It
may worsen the condition.

• Do not use this unit when the external auditory canal is wet such as after swimming or
taking a bath. It may injure the external auditory canal.

• Do not use this unit without attaching a probe cover.

• Please ensure that the ear canal is clean and free of earwax.

• If the probe cover becomes dirty with earwax or other substances, replace it with a new
one.

• Do not use a probe cover after someone else has used it. This can lead to cross infections
such as otitis externa.

• Correct measurement result may not be obtained if dirty probe covers are used.

• Proper installation of the probe cover ensures accurate measurements.

• When the infrared sensor becomes dirty, wipe it lightly with a soft dry cloth or a cotton
swab. Do not wipe the infrared sensor with tissue paper or a paper towel.

• Do not use more than one probe cover at a time.

• If there is any temperature difference between the places where the unit is stored and
where you are going to measure, leave the unit in the room where you are going to use it for
more than 30 minutes to allow it to reach room temperature first, then measure.

• If the ear is cold, wait until the ear is warmed up before taking a temperature measurement.
The measured result may indicate low when you use an ice bag or an ice pack or
immediately after coming in from the outside in winter.

• Do not touch the infrared sensor with a finger or breathe on it.

• Do not attempt measurements when the unit is wet as inaccurate readings may result.

• Check the symbol on the display before and after the measurement so that the
measurement is taken in the appropriate mode.

• When taking temperature of the subject with low emissivity such as gold or aluminum
inaccurate readings may result.

• Keep the unit out of children’s reach.

• Avoid children trying to measure themselves or others as they may damage the ear.

• In an emergency case, if a child swallows a battery or a probe cover, immediately consult
with a doctor.

• Do not throw batteries into a fire. The battery may explode.

• Remove the battery when the unit will not be used for 3 months or more. Failure to do so
may lead to fluid leakage, heat generation or bursting, resulting in damage to the unit.

• Do not use the unit in places where strong static electricity or electromagnetic fields are
present. Doing so may lead to inaccurate readings and may contribute to instrument failure.

• Do not use the unit to measure any item with a temperature higher than 80.0°C (176.0°F).

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)

General Precautions

• Do not apply a strong shock to, drop, step on, or vibrate the main unit.

• Do not use a mobile phone near the unit.

• The main unit is not waterproof. Be careful when handling this unit so that no liquid (alcohol,
water, or hot water) will get into the main unit. When the unit is wet with vapor, wait until it
dries or wipe it lightly with a soft dry cloth.

• 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
Model: OMRON Gentle Temp 521 (MC-521-E)
Sensing Unit: Thermopile
Temperature Display:

Measurement Accuracy: Ear Measurement Mode:

Measurement Range:
Power Supply: 3.0V DC, 1 CR2032 Lithium Button Battery
Power Consumption 0.015 W
Battery Life With a new battery approx. 2,500 measurements or

Operating environment
Temp and Humidity:

Storage environment
Temp and Humidity:

Protection against electric shock: Internally powered ME equipment
Applied Part:

4-digit, F display in 0.1 degree increments
3-digit, C display in 0.1 degree increments

± 0.2°C (± 0.4°F) within 35.5°C to 42.0°C (95.9°F
to 107.6°F), ± 0.3°C (± 0.5°F) for other range
Surface Mode:
±0.3°C (± 0.5°F) within 22.0°C to 42.2°C (71.6°F
to 108.0°F), for other range it is ±2°C (± 3.6°F) or
4% whichever is greater.

34.0C (93.2F) to 42.2C (108.0F)

more

Ambient environment 25 ± 15C, 50±40% RH

10 °C (50°F) to 40°C (104°F), 0 ≤ RH ≤ 85%

-20 °C (-4°F) to 50°C (122°F), 0 ≤ RH ≤ 85%

Weight: Approx. 85 g (including battery installed)
Outer Dimensions: 36 mm (w) x 161 mm (h) x 56 mm (d)
Package Contents: Test Battery (Lithium Button Battery CR2032), probe

Options: Probe cover exclusively for Gentle Temp 521, MC-EP2

= Type BF

cap, 21 probe covers, connection ring, instruction
manual, warranty card

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Materials Used

Component Material

CAP 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 ZIP Lock Bags_ LLDPE Film + HDPE Ring

Probe cover Detect Polyoxymethylene, polyacetal

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Title page of Instruction Manual

(9 languages – English / French / German / Italian / Spanish / Dutch /

Russian / Turkish / Arabic

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OMRON Gentle Temp 521 (MC-521-E) Package Design

Packaging specifications
:

Main Unit

Package

Master Carton

Dimensions WxDxH Qty Weight

36x56x161mm - 85g

115x59.5x197mm 1 343g

497x420x340 40 15KG

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Operation and Care

Please check the device if damaged after it is dropped. If unsure, please contact the
OMRON retail outlet or distributor for having the device checked.

Surface cleaning

Wipe the external surface with a soft dry cloth. The probe is the most delicate part
of the unit. Use care when cleaning the Infrared sensor to avoid damage.

Storage

• Do not store the unit in the following types of places. Doing so may damage the
unit.

- Wet locations.

- Locations with high heat and humidity or those that are exposed to direct sunlight.
Areas close to heating equipment, dusty locations, or environments where there are
high salt concentrations in the air.

- Locations where the unit will be subjected to leaning over, falling, shock or vibration.

- Pharmaceutical storage areas or locations where corrosive gases are present.

Servicing

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.

Warranty card text as included in the product

This product is guaranteed by OMRON for a period of 3 years after the date of
purchase. The proper construction, workmanship and materials of this product is
guaranteed by OMRON. During this period of guarantee OMRON will, without charge
for labour or parts, repair or replace the defect product or any defective parts.

The guarantee covers only products purchased in Europe, Russia and other
CIS countries, Middle East and Africa.

The guarantee does not cover any of the following:
a. Transport costs and risks of transport.
b. Costs for repairs and / or defects resulting from repairs done by unauthorized
persons.
c. Periodic check-ups and maintenance.
d. Failure or wear of accessories or other attachments other than the main device
itself, unless explicitly guaranteed above.

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e. Costs arising due to non-acceptance of a claim (those will be charged for).
f. Damages of any kind including personal caused accidentally or from misuse.

Disposal

Description

As there is a risk of environmental pollution, follow your applicable national and local
legal regulations regarding disposal or recycling of this equipment and batteries.
The main constituents of each part are listed in the table “Materials List”’ on page 9.

Warranty

Warranty term for the ear thermometer- 3 years.

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.

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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.

The device under registration is equivalent to the earlier registered equivalent
device in the context of its intended use, field of application, technology, quality,
reliability, main specifications, lifetime, operating and storage conditions, safety,
functional peculiarities, efficiency and other parameters.

Comparative table of the product with the Previous Model

Medical device under registration

Pictures of the
devices

Earlier registered analogue

Product
Description:

Model: OMRON Gentle Temp 521

Sensing Unit: Thermopile Thermopile

Temperature
Display:

Measurement
Accuracy:

Digital Ear Thermometer Digital Ear Thermometer

Omron Gentle Temp 510 (MC-510-E2)

(MC-521-E)

4-digit, F display in 0.1 degree
increments
3-digit, C display in 0.1 degree
increments

± 0.2C (± 0.4F) within 35.5C to

42.0C (95.9F to 107.6F)
± 0.3C

± 0.5F) forother range

In 3 digits of +C, every 0.1 F or C

± 0.2C (± 0.4F) within 34.0C to

42.2C (93.2F to 107.9F)

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y

y

y

Measurement
Range:
Power Supply: 3.0V DC, 1 CR2032 Lithium Button

Power
Consumption
Battery Life With a new battery approx. 2,500

Operating
environment
Temp and
Humidit
Storage
environment
Temp and
Humidity:
Protection
against electric
shock:

Applied Part:

Weight: Approx. 85 g (including battery

Outer
Dimensions:
Package
Contents:

Options: Probe cover exclusively for Gentle

:

34.0C (93.2F) to 42.2C (108.0F) 34.0C (93.2F) to 42.2C (108.0F)

3.0V DC, 1 CR2032 Lithium Button

Batter

0.015 W 0.05W

measurements or more (Ambient
environment
25 ± 15C, 50±40% RH)
10 °C (50°F) to 40°C (104°F)
0 ≤ RH ≤ 85%

-20 °C (-4°F) to 50°C (122°F), 0 ≤ RH
≤ 85%

Internally powered ME equipment Internally powered ME equipment

installed)
36 mm (w) x 161 mm (h) x 56 mm (d) 46 mm (w) x 93 mm (h) x 57 mm (d)

Test Battery (Lithium Button Battery
CR2032), probe cap, 21 probe
covers, connection ring, instruction
manual, warranty card

Temp 521, MC-EP2

= Type BF = Type BF

Batter

With a new battery approx. 5000
measurements

10 °C (50°F) to 40°C (104°F)
30 - 85% RH

-20 °C (-4°F) to 60°C (140°F)
10 - 95% RH

Approx. 50 g (including battery
installed)

Main unit, Storage case, 10 probe
covers, instruction manual, warranty
card, information sheet (2 pieces)

Probe cover exclusively for Gentle
Temp 510, MC-EP1

On the basis of protocol of tests for conformity to standards requirements, technical
specifications of medical devices and the comparative table above we can make a
conclusion that the functional peculiarities, safety, efficiency and quality of the new
device are equivalent to the previous device.

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