User's Manual

ManualsBrandsT&R BIOFAB ManualsElectronicsTHERMOCARE

Doc. #.: PR2QM-01_rev.E00(20.09.23)

[Product name】

THERMOCARE

【Model name】

MT-1000 / MT-3000 / MT-4000

【Safety Sign】

Symbols for safety signs are indicated and

described on the product exterior, packaging,

and in this manual.

Symbols provide users with important cautions,

warnings, and prohibitions. You should carefully

look at the symbols shown below and use this

information for the use and storage of the

product.

Caution

This safety sign

stands for caution.

This relates to

problems with

possible damage

to the product or

to patient harm.

Warning

This safety sign

stands for a

warning. This is

related to the

problem of

possible damage

or cause

irreversible

damage to the

product or the

patient.

Prohibition

This safety sign

means prohibition.

This relates to

problems with

possible damage

to the product or

to patient harm.

Obligatory

action

This safety sign

means "Refer to

the user manual."

* Where deemed necessary, manufacturers are

not obligated to make changes to the same

specifications as products that have already

been sold, with respect to improvements to

improve the performance of their products.

Warning

1. Use a battery of the specified rating and size

(1.5 V, AA size) and replace it correctly

according to the + and - directions marked on

the battery replacement section. Improper

replacement may cause overheating of the

battery or a risk of fire or explosion.

2. Other devices may malfunction due to the

electromagnetic waves generated by this

device, and this device may malfunction due to

electromagnetic waves generated by other

devices. Do not use adjacent to other devices

or load other devices .

3. Do not use this product near equipment that

emits RF energy, such as electric cautery or

electric surgery equipment. Body temperature

may not be measured by RF energy or may

result in inaccurate measurements.

FCC Information

This device complies with part 15 of the FCC

Rules. Operation is subject to the following two

conditions:

1. This device may not cause harmful

interference, and

2. This device must accept any interference

received, including interference that may cause

undesired operation.

FCC notification to users

This equipment has been tested and found to

comply with the limits for a CLASS B digital

device, pursuant to Part 15 of the FCC Rules.

These limits are designed to provide reasonable

protection against harmful interference when the

equipment is operated in a commercial

environment. This equipment generates, uses,

and can radiate radio frequency energy and, if

not installed and used in accordance with the

instructions, may cause harmful interference to

radio communications. However, there is no

guarantee that interference will not occur in a

particular installation. If this equipment does

cause harmful interference, the user is

encouraged to try to correct the interference by

consulting with a dealer or an experienced

technician for technical assistance.

Any Changes or modifications to the equipment

not expressly approved by the party responsible

for compliance could void user’s authority to

operate the equipment.

【Applicable standards and references】

1. EN 60601-1:2013, IEC 60601-1:2012 Medical

electrical equipment Part1: General

requirements for basic safety and essential

performance

2. EN 60601-1-2:2015, IEC 60601-1-2:2014

Medical electrical equipment-Part 1-2:

General requirements for basic safety and

essential performance – Collateral

standard: Electromagnetic compatibility -

Requirements and tests

3. EN 60601-1-6:2010, IEC 60601-1-6:2010

Medical electrical equipment-Part 1-6:

General requirements for basic safety and

essential performance-Collateral

Standard: Usability

4. IEC 60601-1-11:2015 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

5. ISO 13485[2016], EN ISO 13485[2016] Medical

devices-Quality management

system-Requirements for regulatory

purposes

6. EN 1041:2008 Information supplied by the

manufacturer of medical devices

7. ISO 7010:2019 Graphical symbols–Safety

colors and safety signs– Registered safety signs

8. EN ISO 15223-1:2016, ISO 15223-1:2016

Medical devices - Symbols to be used

with medical device labels, labelling and

information to be supplied - Part 1:

General requirements

Summary of content (4 pages)

PAGE 1
irreversible electric surgery equipment. Body temperature damage to the may not be measured by RF energy or may product or the result in inaccurate measurements. 【Applicable standards and references】 patient. 1. EN 60601-1:2013, IEC 60601-1:2012 Medical FCC Information electrical equipment Part1: General means prohibition. This device complies with part 15 of the FCC requirements for basic safety and essential This relates to Rules.
PAGE 2
display temperature, measurement batteries. is displayed. mode and battery status 【Instructions for disposal】 2 6 Measurement It is used in case of selecting Object ◆ Screen description mode selection one out of 3 types of mode.
PAGE 3
product. 4. The temperature measurement range of object 2. Press the Power/Measure button to turn on is 10°C ~70°C. ◆ Operating temperature: 16℃ ~ 40℃ attempt to repair. Contact the Customer Center. the power. 8. Keep in room temperature and if it has not 【Measuring 【Measuring body temperature】 surrounding 1. Press the Mode setting button for more than3 seconds measuring temperature/humidity. / “Object, measurement sound ON” for setting. 2.
PAGE 4
the following circumstances. 1) Infant under 90 days old 2) In case measurement out of the average body temperature has been displayed in a automatically turned off after 15 seconds. Center. However, in case of Bluetooth operation, the Cause power is automatically turned off after 1 minute When and 15 seconds. range is exceeded - child under the age of 3.