MinttiHealth Coola Bedienungsanleitung
I
Continuous Monitoring
Thermometer
Model: Coola
■ Version：A0
■ No：WI-Coola-0014
■ Release Date: 2018/09/12
Suzhou Melodicare Medical Technology Co., Ltd.
Instruction For Use
II
Contents
1.Foreword.....................................................................................1
2.Product Ddescription..................................................................3
3.Preparation before use................................................................4
4.Instructions................................................................................11
5.Maintenance and Cleaning........................................................24
6. Appendix...................................................................................27
1. Foreword
Thank you for purchasing the Continuous Monitoring
Thermometer.
In order to use the product safely and correctly, please
read the instructions carefully before use.
Before use, please check whether the accessories are
complete according to the packing list, and check
whether there is any breakage and damage to the
product appearance and buttons. After installing the
battery, turn on the power button and check whether
the indicator flashes is in blue .
1.1 Security Information
Precautions
Before using this thermometer, please read this
manual carefully and fully understand the warnings
and risks.
This electronic thermometer is applied only to the
underarm unless otherwise the measuring
discrepancy will occur.
The user’s posture and physical conditions may
affect measuring accuracy.
When measuring, keep thermometer in your armpit
tightly.
Any move of the users will result in inaccuracy for
measuring.
Any move of the thermometer in use will make
measuring inaccurate.
The loose contact between the probe and the
measuring position may result in inaccurate
measurement.
If the thermometer is taken out before the
complete measurement, the measurement result
will be inaccurate.
Measurements will become abnormal right after
the sports activities, diet, and bathing.
Having a rest before taking the measurement.
Ensuring thermometer measuring under proper
and required conditions.
The measuring results should not be based solely
on personal experience but duly constancy with
professional physicians
Warning
Do not use this product in the environment of
strong electromagnetic interference.
This product is non-water proof and do not soak
the thermometer directly in water.
Please do not dismantle or repair yourself but
contact the manufacturer for after-sale service
when any damages or obstacles occur to this
product
Please remove the batteries when the product is in
no use for some long time
Do not put the product in a strong acid or alkali
environment, or it may affect the product life and
accuracy of measurement results.
Improper replacement of lithium batteries may
pose an unacceptable risk
This app is applicable to phones with blue tooth
4.0, Android4.3 or above, IOS6.1 or above. In
order to avoid any possible damage to your phone,
please confirm that your phone system meets with
the requirements before use
Do not perform maintenance operations during
use
This product contains batteries and electronic
components, do not close to fire or heat source.
The product bears small parts and components ,
please keep it out of Children’s reach. The use by
Children of this product must be under the
guardian of adults
The electronic thermometer has been ex-factory
calibrated,
do not calibrate it by yourself, but contact the
factory for any calibration in need.
The equipment or system shall not be used close
to or stacked with other equipment.
Unless otherwise it is so required, the user has to
observe and prove this will work properly together
In addition to cables sold by the manufacturer of the
equipment or system as spare parts for internal
components, the use of non-prescribed accessories and
cables may result in increased emission or reduced
immunity of the equipment or system.
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this
equipment and the other equipment should be observed
to verify that they are operating normally.
Use of accessories, transducers and cables other than
those specified or provided by the manufacturer of this
device could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
inches) to any part of the device, including cables
specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
Do not store the product outside the rated storage
temperature and humidity range;
Do not use this product in environmental
conditions outside the rated operating
temperature and humidity range
Severe impact, such as dropping, may damage
the equipment and cause the accuracy of the
equipment to decrease;
When the patient's temperature is lower than the
ambient temperature, the measurement may not
be accurate.
Attention
The Electronic Thermometer conforms to the
related requirements of electromagnetic
compatibility of IEC60601-1-2 standard.
Users shall install and use the electromagnetic
compatibility information provided in the
accompanied files with the sale of this product
Avoid strong magnetic interference sources such
as smart phones , micro ovens in order that the
Electronic Thermometer function fully and properly
Please refer to the guidance and manufacturer's
statement attachments.
The patient is the intended operator
1.2 Symbol
Symbol
Significance
Attention,warnings
Type B application device
Caution
The electronic waste should be
disposed by professionals after use
Manufacturer
Lot Number
Manufacturer
CE mark
IP22
2 Protected against solid foreign
objects of 12,5 mm Ø and greater；
2 If keep the thermometer in 15
degree angle, it still can prevent
the water drop.
2. Product description
2.1 Product name and model
Product Name: Continuous Monitoring Thermometer
Product model: Coola
2.2 Expected usage
The electronic thermometer is suitable for measuring
the body temperature under the armpit
2.3 Indications for Use
Intended use:
The device is intended to be used for measuring the
body temperature under the armpit for 48 hours. The
device is intended to be used at home or healthcare
facilities. The device is not intended for infants less
than three months.
Contraindications:
The product is should not be used when accurate
measurement of body temperature will influence
clinical decisions and should not be used persons
with an implanted pacemaker.
Side effects:
Skin rash or reaction due.
Patient Profile:
All patients(age: more than 3 months) who meet
indications but do not meet contraindications.
User profile:
There is no specific user identification for the device.
It can be used by experts or non-specialists in
accordance with the conditions specified in the user
manual.
2.4 Product Specifications and Parameters
Description
Electronic Thermometer
Model
Coola
Voltage
d.c.3.0V（lithium battery
CR2016）
Temperature Sensor
thermistors
Measuring Method
actual measurement
Measuring Position
armpit
Temperature Display
Model
3-digital display
Measuring Accuracy
lower than 35.3℃±0.3℃；
35.3℃~36.9℃±0.2℃；
37.0℃~39.0℃±0.1℃；
39.1℃~41.0℃±0.2℃；
Higher than 41.0℃±0.3℃。
Measuring Range
33℃~45℃
Measuring Time
10min
Minimum measurement
time
2min
The time required from a
cold or hot storage
environment to 20
degrees Celsius
equipment can work
normally
2 hours
Wor
king
Con
ditio
ns
working temp
and humidity
5°C~40°C；≤85%RH
storing temp and
humidity
-10°C~55°C；≤95%RH
operating air
70~106kPa
pressure
Transit and
storing air
pressure
50~106kPa
Overall Dimension
38mm×38mm×4mm
Product life expectancy
3 years
Battery life expectancy
5 years
Typical usage time
120h
Electric Shock
Protection
internal power supply ,type B
application
Disinfection
and Sterilization Method
as per recommended cleaning
by the manufacturer
Safety Classification
Don't use in the presence of a
mixture of flammable
anesthetic gas and air or with
oxygen or nitrous oxide.
Working
system classification
continuous operation
Packing List
Thermometer x1
Battery x1
User’s manual x1
Q.C certificate x1.
*The specs are subject to change without further notice
2.5 Product structure and composition
The electronic thermometer is complete with the main
body of the thermometer and the smart phone
application. The main body of the thermometer
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