chois XST400-BT Electronic Thermometer User Manual

USER MANUAL
Electronic Thermometer (XST400)

****| OBELIS S.A
Bd. General Wahis 53 1030 Brussels, BELGIUM
Tel : +32 (0)2.732.59.54, Fax : +32 (0)2.732.60.03
---|---
| CHOISTechnology Co., Ltd.
Manufactured for KM HEALTHCARE
7811 N. Shepherd Dr. Ste# 215-A, Houston,
Texas 77088, USA

0123

| Documentation: UM-XST400-001
Revision History: V1.01 Date: Jan 11, 2021

Chapter 1. Introduction

summary

This product is Class II, Non-Invasive Device.
The electronic thermometer is a device that measures the body temperature using the thermistor resistance change. The body temperature display must be connected to the mobile app installed on the smartphone so that it can be displayed. Smartphones are not provided as components of this product.

Intended Use

Measuring instrument for measuring the body temperature of a patient by using the electrical properties

Intended Operator

1.3.1 Education
At least 11 years – 5 years of intensive reading experience (school)

1.3.2 Knowledge
Be able to distinguish body position (measurement site, chest, armpit)

1.3.3 Understanding languages
To understand English or the user manual.

1.3.4 experience
No experience required

1.3.5 Acceptable faults
No specific information

Indications

– No record.

Side Effects and Contraindications

– No record.

Before Use

1. Be sure to read and use the user manual.
2. Do not use it for other purposes.
3. Stabilize the state of the person before the measurement and make the measurement in the correct state.
4. The temperature detecting unit of the body temperature sensor is brought into close contact with the skin. Use in the body cavity is prohibited.

Chapter 2. Safety (Cautions and Warning)

Danger

1. Be sure to use the specified rated battery and check the polarity of the battery.

Warning

1. If an abnormality is found in the instrument, immediately stop the operation of the instrument, remove the instrument from the human body and ask the manufacturer for inspection.
2. Do not exchange batteries arbitrarily.

Caution

1. This electronic thermometer can be used for all ages. However, please be sure to use as directed by your doctor if you have a severe high fever.

2. Be careful not to use the device by the not intended operator.

3. Be careful not to cause damage to the device.

4. Be careful not to let liquid or foreign matter get into the body.

5. Please contact the manufacturer if any of the following situations occur.
   – If you have a skin reaction (urticaria, allergies, etc.)
   – If something is wrong with the whole device
   – In case of using in parallel with other medical devices, change of measured body temperature occurs remarkably

6. If the unit detects heat, be sure to remove it from your body.

7. It should not be used in the same place where there is equipment with strong electromagnetic waves (e.g. X-ray, MRI, etc.)

Notice

1. Since this electronic thermometer should be used in conjunction with a smartphone, the operation may not be smooth depending on the location and power status of the smartphone. Please observe the following.
   – Maintain the power supply status of the smartphone by using an auxiliary battery or adapter for continuous measurement of body temperature.
   – Since the normal temperature measurement range is within 15m from the thermometer, be careful not to let the smartphone deviate more than 10m.
   – When using in two connected rooms, distance to use may be significantly reduced. Use in one independent space if possible.

2. This electronic thermometer can be used for all ages, but please be aware of the following when using Young or Infant.
   – Measures should be taken after 30 minutes or more after the infant enters the room from outside or moves the thermometer to a different temperature environment.
   – The sensor part on the back of the product is very sensitive and should always be kept clean and intact for accurate measurement.
   – In the case of body temperature measurement for infants, in case of severe strangulation, the distance between skin and sensor may not be kept constant, so measurement error may occur.
   – Do not allow infants or children to touch the thermometer sensor and battery with their mouths or with wet hands.

3. This electronic thermometer is attached to the body, please note the following points.
   – limitation for contact duration : 24hour – 30days

Chapter 3. Specifications

System, Contents, Feature Description

NO.

| Name|

Function

---|---|---

a

| Case| Protect PCB ASS’Y, shape product

b

| Temperature Sensor| Detect human body temperature and convert it to digital signal

c

| Button| button to operate the product

d

| LED Indicator| Display the Device status
LED OFF: Sleep mode
LED ON: Active mode

Product Performance

Section

|

Specification

---|---
Battery| CR2016 (DC 3V
Measurement Range| 50°F – 140°F
Accuracy| ± 0.18°F (77°F – 113°F)
± 0.36°F (50°F – 76°F, 114°F – 140°F)
Minimum unit| 0.01°F
Measurement Method| Thermistor/Direct mode only
Measurement site| armpit
Measurement Display| Bluetooth communication with your smartphone to show in your mobile app
Mesurement Transient time| After 15-20 minute
Use Distance| Max 15m
Lift time| Max 3days
Software Version| Firmware: Ver. 1.0.0
Mobile App: Ver. 1.1.0

Product Characteristics

1. Protection for electric shock
   Internal Power device, BF type applied part

2. Waterproof grade
   IP22 (according to IEC529)
   • Protected against a solid object greater than 12.5mm, such as a finger.
   • Protected against water drops at a 15degree angle.

Label

Pictogram

| Community European
---|---

0l23

| Notified Body
| Catalog number
****| Serial number
| Manufacturer
| Authorized Representative in the European Community

| Date of manufactured
| Keep dry
| DC

| Class II Equipment
| BF type applied part

| Caution

| Consult Instruction for use
| Do not dispose of with domestic waste
| Do not re-use, use only once.

Environmental condition(Storage, Transfer, Operation)

1. Storage Condition
   Temperature : 50°F – 158°F
   Humidity : 0 – 93 % RH
   Air pressure : 700 – 1,060 hPa

2. Transfer Condition
   Temperature : 50°F – 158°F
   Humidity : 0 – 93 % RH
   Air pressure : 700 – 1,060 hPa

3. Operation Condition

4. Temperature : 41°F – 140°F
   Humidity : 15 – 93 % RH
   Air pressure : 700 – 1,060 hPa

Chapter 4. Operation

Preparation before use (before operation)

1. Stabilize the state of the person before the measurement and make the measurement in the correct state.
2. The temperature detecting unit of the body temperature sensor is brought into close contact with the skin. Use in body cavity is prohibited.

How to operation

1. Install a mobile app on your smartphone.
2. Activate the Bluetooth function of the smartphone.
3. Place the operating button of the device on and check whether the LED indicator is on.
4. Run the mobile app and select the thermometer you searched for.
5. Check that the initial temperature is displayed on the mobile app when the thermometer is normally connected.
6. Attach the thermometer to the side using the patch.
7. Changes in body temperature information will be stabilized after about 15 to 20 minutes.

Precautions when opeation

1. If there is any problem with the device, stop operation and contact the manufacturer.

After operation management methods

1. Avoid contact with water. Do not store near water.
2. Do not use in places subject to adverse influences such as air pressure, temperature, humidity, wind.
3. Pay attention to the stable state such as vibration and shock (including in transportation).
4. Do not store in chemical storage area or gas generating place.

Chapter 5. Routine maintenance

Routine check

1. Be sure to clean the surface of the product with a cloth or cloth.
2. Please check the storage conditions and usage conditions of the product.
3. You do not need to take a separate calibration.

Chapter 6. Trouble shootings

Symptom| Possilble Reason|

Solution

---|---|---
The temperature data cannot be displayed property.| 1. Low battery of Instrument| 1. Turn on again
2. Please replace battery.
Cannot turn on Instrument| 1. May the battery power is shortage or no electricity
2. There are some problems of the instrument.| 1. Turn on again
2. Please replace battery
3. Contact customer service
Unusual temperature data| 1. The position of Instrument is not correct
2. There are some problems of the instrument.| 1 . Check the position of Instrument
2. Contact customer service
Mobile App error
1. User data not saved,
2. Wrong data received,
3. Measurement error
4. Alarm error (High temp, Low temp, Lowbattery, Disconnection.)| 1. The app may not install properly or may not be compatible with your smartphone.| 1. Contact customer service

Chapter 7. Shop for supplies, A/S

Supplies list and Purchase path

NS explanation

If you have any problems while using the product, or if you need to improve things, please contact the following contact details and we will kindly consult you.
Email: cs@kmact.com/Fax 281-405-0891
Homepage: https://kmact.com

Warranty

1. The warranty period for this product is 1 year from the date of manufacture.Any defect of the product caused by materials and mechanical problems will be covered for free for a year.
   If our model you purchased is found to be defective within that time, we will promptly repair or replace it.
   However, this warranty does not cover problems or damages resulted from unauthorized repair, modification or disassembly.

2. If any of the following situations occur within the warranty period, it will be charged.
   – In case of malfunction due to user’s mistake
   – failure or damage caused by the arbitrary disassembly, modification of structure, performance, and function
   – failure or damage caused by the use of the product other than its intended purpose
   – In case of malfunction due to carelessness such as dropping and flooding after purchase
   – failure due to natural disaster(earthquake, fire, flood, lightning)

Chapter 8. EMC Compliance

Electromagnetic Emission

The product is suitable for use in an specific electromagnetic environment. The customer and/or the user of the product should assure that it is used in an electromagnetic environment as described below.

function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment.
RF-emission CISPR 11| Class A| The product is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purpose.

Electromagnetic Immunity

The product is suitable for use in a specific electromagnetic environment.
The customer and/or the user of the product should assure that it is used in an electromagnetic environment as described below.

Immunity Test| IEC 60601- Level| Compliance Level|

Electromagnetic Environment Guidance

---|---|---|---
Electrostatic discharge(ESD) IEC61000-4-2| ± 8kV contact
± 15kV air| ± 8kV contact
± 15kV air| Floor should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %
Radiated RF IEC 61000 4 3

| 3 V/m
80 MHz
to 2.5 GHz| 3 Vin–i| Recommended separation distance:
d = 1.2VP
d = 1.2VP
for 80 MHz to 800 MHz
d = 2.3ViD
for 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in Watt OM according to the transmitter manufacturer and d is the re-commended separation distance in meters (m) Field strengths from fixed RF t ransmitters, as determined by an electromagnetic site survey a, **should be less than the compliance level b in each frequency range Interference may occur in the vicinity of equipment marked with the symbol described lateral.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:** These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, people and animals.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered, if the measured field strength in the location in which the product is used exceeds the applicable RF compliance level above, the product should be observed, additional measures may be necessary, such as reorienting or relocating the product.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended Separation Distances between portable **and mobile HF-

communications equipment and the product
**

The product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the product — according on output power and frequency of the communications equipment — as recommended in. the following table.

Rated maximum output power of transmitter in watts (W)|  Separation distance according to the frequency of transmitter in meter (m)
---|---
150 kHz to 80 MHz d =1 .2VP| 80 MHz to 800 MHz d = 1.2VP| 800 MHz to 2.5 GHz d = 2.3VP
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100|  12| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (IAT, according to the transmitter manufacturer.
Note 1: At 80 MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, people and animals.

Chapter 9. Wastes

Instructions for waste procedure

9.1.1 Disposal of Electronic Thermometers

– Follow local laws, standards and guidelines for disposal of used electrical equipment.
– Do not allow parts to be contaminated during disposal.

9.1.2 Disposal of packaging materials

– All packaging materials can be disposed of or recycled in an environmentally friendly manner.
– Please send the old packing materials to the recycling collection companies for the prevention of waste and recycling of raw materials.

Radio Regulations:
FCC Part 15 Industry Canada License exempt RSS standard(s) ISO/IEC 60601-1-2 Electromagnetic Compatibility

FCC Statement and Legal Notices
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 WARNING: any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment under FCC regulations.

FCC RF Radiation Exposure Statement: This equipment complies with FCC RF Radiation exposure limits set forth for an uncontrolled environment. This device and its antenna must not be co-located or operating in conjunction with any other antenna or transmitter.

FCC ID: RVBXST400-BT
Model: XST400
Responsible Party: KM HEALTHCARE 7811 N. Shepherd Dr. Ste#215-A, Houston, Texas 77088, USA, TEL: 281-405-0888

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