EU User Manual English

User Manual

EU-Market

CONTENTS

Intended Use
Functions
Contraindications
Product Composition
Product Specification and Performance Characteristics
Product Structure
Product Safety Class
Applied Mobile Phones (Network, Data Couplings)
Cautions for Battery Charging
Power ON & OFF
APP Download
Device Connection
Cautions for Using the App
App Troubleshooting
Instruction for Blood Pressure Measurement
Blood Presure Troubleshooting
Calibration of Blood Pressure by Using Static Pressure
Calibration Process
Instruction for Body Temperature Measurement
Body Temperature Troubleshooting
General Warning
Instruction for Blood Oxygen Measurement
Blood Oxygen Troubleshooting
Blood Oxygen Cautions
Instruction for ECG Measurement
ECG Troubleshooting
ECG Cautions
Maintenance
Symbol Definition
EMC Declaration

Thank you for using this Health Monitor. Please read this User Manual carefully to use the medical device safely and correctly.

Intended Use

The health monitor from Qlupod is designed for measuring and transmitting* body temperature, blood pressure, pulse rate, blood oxygen, and ECG.

The device should not be used for self-diagnosis.
The device obtains the body temperature by measuring the forehead area.
The device obtains the blood pressure by measuring the upper arm site.
This product should not encourage self-medication or adaptation of the treatment.
Always consult the doctor if the patient has any questions, or he/she believes he has abnormal measurements.
Blood pressure measurement should not be used for newborns or children under 12 years old.
Body temperature measurement should not be used for newborns or children under 5 years old.
The operator must be able to read English.

Functions

The Health Monitor is a wireless device that uses Bluetooth for signal transmission and needs to be connected to a mobile phone application. With the help of infrared and pressure sensors, body temperature, blood pressure, and pulse rate are measured and transmitted via Bluetooth to the app on the phone. The user can view the temperature, blood pressure, and pulse rate in the mobile app.

Contraindications

Children or anybody that can’t read the instructions should not use the device.
Do not use the device on a body part with injury and skin infection.
Users with blood circulation issues or blood diseases please only use under the guidance of a doctor for those who have disturbance of blood circulation or blood disease.
Self-measurement for blood pressure is not suggested for those with high psychological anxiety.
Blood pressure measurement should not be used for neonatal or children under 12 years old.
Body temperature measurement should not be used for neonatal or children under 5 years old.
This device is not to be used in an ICU.

Product Composition

The Health Monitor consists of the device, cuff and mobile-phone application program. The device is mainly composed of PCB, Plastics, Rechargeable Lithium-Ion Battery, Pump, etc.

Product specification and performance characteristics

The Health Monitor consists of the device, cuff and mobile-phone application program. The device is mainly composed of PCB, Plastics,Rechargeable Lithium-Ion Battery, Pump, etc.

Product Name	Health Monitor	Product Model	HC-03
Software	Health Monitor	SW-Version	V0.0.10
Battery Nominal Voltage	3.N	Input Voltage	5V ± 0.25V
Battery Rated Capacity	400mAh	Size	70mm x 70 mm x 18.4mm
Working Frequency	2.4000-2.4835GHz	Net Weight	About 70g
Communication Protocol	Bluetooth 4.0	Resting pressure rated range	0-300mmHg
Validity period of product	3 Years	Validity period of cuff	2 Years
Lifetime of battery	Charge-discharge cycles 300 times
Bood Pressure measurement	Bood Pressure measurement	Body Temperature measurement	Body Temperature measurement
Measurement body part	Upper arm	Measurement body part	Forehead
Circumference	22-35cm	Measurement scop	28-42 C
Measurement scope of systolic pressure	60-230nvnHg	Measuring error	i0.2C, for 35-42 C i0.4C, for <35 C
Measurement scope of diastolic pressure	40-130mmHg	/	/
Pressure error	±3mmHg	/	/
Measurement scope of pulse rate	40-180bPm	/	/
Pulse rate error	±5%	/	/
Temperature	5 C-40 C	Temperature	-25 C - +70 C
Humidity	15%-93%	Humidity	93%
Atmospheric Pressure	70-106 kPa	Atmospheric Pressure	50-106kPa

Product Name	Health Monitor	Product Model	HC-03
Software	Health Monitor	SW-Version	V0.0.10
Battery Nominal Voltage	3.N	Input Voltage	5V ± 0.25V
Battery Rated Capacity	400mAh	Size	70mm x 70 mm x 18.4mm
Working Frequency	2.4000-2.4835GHz	Net Weight	About 70g
Communication Protocol	Bluetooth 4.0	Resting pressure rated range	0-300mmHg
Validity period of product	3 Years	Validity period of cuff	2 Years
Lifetime of battery	Charge-discharge cycles 300 times
Bood Pressure measurement	Bood Pressure measurement	Body Temperature measurement	Body Temperature measurement
Measurement body part	Upper arm	Measurement body part	Forehead
Circumference	22-35cm	Measurement scop	28-42 C
Measurement scope of systolic pressure	60-230nvnHg	Measuring error	i0.2C, for 35-42 C i0.4C, for <35 C
Measurement scope of diastolic pressure	40-130mmHg	/	/
Pressure error	±3mmHg	/	/
Measurement scope of pulse rate	40-180bPm	/	/
Pulse rate error	±5%	/	/
Temperature	5 C-40 C	Temperature	-25 C - +70 C
Humidity	15%-93%	Humidity	93%
Atmospheric Pressure	70-106 kPa	Atmospheric Pressure	50-106kPa

Product Structure

Product Safety Class

Protection against electric shock	Class II
Applied parts	BF
Protection against harmful ingress of water or particulate matter	IP22
Mode of operation	Not continuous operation
Used in an Oxygen rich environment	Not intended for use in Oxygen rich environment

Applied mobile phones (Network, Data Couplings)

The Health Monitor should be used together with the application program on mobile phones. The mobile phone should satisfy the following two requirements.

Bluetooth 4.0
Android 4.3 or higher version, iOS 7.0 or higher version.

Package List Accessories

Health Monitor x1, Cuff x1 and User Manual x1

List Battery Charging

Cuff (XD-01) x1 and USB line x1
The color of battery icon on APP means electric quantity status.

RED: The battery is near power off
YELLOW: Low power
GREEN: Sufficient power
BLUE: Full power

Cautions for battery charging

Please charge timely when low power caution appears on the APP.
Power light is blue and flickering during charging.
Do not use the device during charging.

Power ON and OFF

Power ON: press power key 2 seconds. The device shakes slightly. Power on is successful with blue power light. Power OFF: press power key 2 seconds. The device shakes slightly. Power off is successful with power light off.

APP Download

Go to the respective App stores and search for Qlupod.

Device Connection

Press the power key and hold 2 seconds to power on. Open the APP. The device will connect to the APP automatically with the electrical quantity icon appearing on the APP. If the electrical quantity icon is not shown on the APP, click the Bluetooth icon to set up the connection manually.

Cautions for using the APP

Confirm the system specification in the mobile phone complies with the requirements before downloading the APP.
To set up the automatic connection between mobile phone and device, the device should be powered on before logging into the APP.
Most malfunctions can be solved after rebooting the device and the APP.

Troubleshooting

Malfunctions	Reason	Solution
Failure of downloading the APP	Mobile phones do not satisfy the requirements	Check the version of Bluetooth and system of mobile phone
Failure of automatic connection	Wrong operation sequence	Power on the device first, then log into the APP or connect manually.
Failure of connection or finding the device	Weak sensitivity of Bluetooth of mobile phone	Power on the device first, then log into the APP or connect manually.

Instruction for blood pressure measurement

Blood pressure measurement will be influenced by body posture, wearing method of cuff, physical condition, and surrounding environment. The position of the cuff and heart should be kept at the same horizontal level during measurement.

Keep calm for 5 minutes before measurement. Do not speak or talk during measurement to avoid influence on accuracy. Arms should be kept naked or dressed in thin cloth.
Power on the device and buckle it in the cuff correctly. Tie up the cuff 1-2 cm above the upper elbow joint. Degree of tightness should be comfortable.
Sit up straight. Keep the limb positioned on a stable table or platform with proper height. Keep the palm up and relaxed. The position of the cuff and heart should be kept at the same horizontal level during measurement.
Open the APP. The device can connect to the APP automatically or manually with the appearance of an electrical quantity icon on the APP. After the device connects to the APP successfully, select blood pressure in the APP interface and click “Start”. The cuff will be inflated, and measurement will be started. Keep calm during measurement.
The system will stop automatically after measurement. The measured value will be shown.
Take off the cuff, and clear up.

Do not evaluate the result only by your own experience. Please consult the doctor.

Troubleshooting

Malfunctions	Reason	Solution
Low reading	Wrong wrapping of cuff: moving, speaking, or wrong sitting posture during measurement.	Wrap the cuff correctly. Adjust the sitting position keep calm during measurement. Please refer to user manual for operation details.
Failure of inflating	Leakage of cuff or wrong position of device.	Re-position the device. Contact the manufacturer to replace the cuff if the cuff is broken.
Failure of measurement	Wrong position of device, or inadequate battery charge.	Check the position of the device by referring to the user manual. Check the power quantity. Ensure the battery is sufficiently charged. Please refer to the user manual for operation details.

Calibration of blood pressure by using static pressure

HC-03 is based on an oscillometer, which means the calculated blood pressure is only accurate if the static pressure is accurate. Therefore, to calibrate blood pressure, static pressure should also be calibrated. FLUCK BP Pump 2 Blood Pressure Simulator is used to calibrate static blood pressure.

Calibration process:

Use the airway tube to connect HC-03 and FLUCK BP Pump 2.
Press “CUFF” and select “Internal”.
Press “Option” and select static pressure of 300-0mmHg.
Run the APP to connect HC-03. Enter engineering test mode by inputting the engineering code.
Select static pressure test item HC-03 closed pressure on the APP.
Press the Start button on FLUCK BP Pump 2 to start the inflation. The inflation will be stopped automatically when the pressure reaches the setting.
Compare the static pressure value on FLUCK BP Pump 2 and APP. The gap should be smaller than ±3mmHg.

General Warning: You do not need to calibrate the QluPod yourself. Calibration is performed before delivery and is not required again within the validity period.

Instruction for body temperature measurement

Power on the device and open the APP. The device can connect to the APP automatically or manually with the appearance of an electrical quantity icon on the APP.
Keep the forehead dry and clean. Take the device and align the infrared detection head to the center of the forehead. Keep the device 1-2 cm away from the skin. Select "Temperature" in the App. Click "Start" for the measurement. The system will stop automatically after the measurement. The measured value will be shown.

Troubleshooting

Malfunctions	Reason	Solution
Big measurement error	Sweat, water, oil etc. on forehead.	Clean the forehead before measurement.
Big measurement error	Leakage of cuff or wrong position of device.	Keep 1-2 cm distance between detector head and forehead.

General Warning

Please read this user manual carefully to use the medical device safely and correctly.
Use the device only in a specified environment. Do not use it in areas with strong electromagnetic interference or high-frequency surgical equipment.
Contact the manufacturer in case of damage or malfunction. Do not disassemble or repair the device yourself.
Do not disassemble or modify the device yourself.
Do not use the device when it requires maintenance. Do not place the device in an environment with high acidity or alkalinity. This can affect the lifespan and measurement accuracy of the device.
The device’s application is designed for smartphones equipped with Bluetooth 4.0, Android 4.3 or higher, or iOS 7.0 or higher. Please ensure your smartphone meets these requirements beforehand to avoid damage.
Keep the device away from fire or heat sources, as it contains battery and electronic components.
Children may use the device under adult supervision.
Keep the device out of reach of children, as it contains small components.
Do not calibrate the device yourself. Calibration is performed before delivery. Contact the manufacturer if calibration is required.
Do not use the device outside the specified temperature range for measurements, as performance may be affected.
Do not store or transport the device outside the specified temperature and humidity range, as this may affect its performance.
The device’s performance may be impacted if the optical component is damaged or contaminated.
The device’s performance may be affected if it is subjected to vibrations or if it has been dropped.
The charger, the mobile screen with Bluetooth, and the health monitor form a medical electrical (ME) system.
A ME SYSTEM should provide:
– within the PATIENT ENVIRONMENT, the level of safety equivalent to ME EQUIPMENT complying with this standard; and
– outside the PATIENT ENVIRONMENT, the level of safety equivalent to equipment complying with their respective IEC or ISO safety standards.
Please use the charger complying with IEC6060l-1 or other relative electrical standards (e.g., IEC6Qg50). Otherwise, there could be the risk of electrical shock.
The mobile devices such as mobile phone connected to the Health Monitor should at least have a protection level of IP22 at least.
Please use the accessories such as cuff and cable specified by the manufacturer. Otherwise, it could lead to inaccurate measurement or damage to the device.
Stop using the device and contact the after-sales service if you find the performance has changed.

Instruction for blood oxygen measurement

Power on the device and open the APP. The device can connect to APP automatically or manually with the appearance of an electrical quantity icon on APP.
Keep still and calm. Place the fingertip of your middle finger on the oxygen detector.
Select ·oximetric in the App. Click “‘Start” for the measurement.
The System will stop automatically after the measurement. The measured value will be shown.

Troubleshooting

Malfunctions	Reason	Solution
Data changed a lot in a short period	Measured way or body gesture was wrong.	Re-measure according to the instruction.
Unable to get measured results	Finger overexerted.	Lightly press the middle finger on the device, do not overexert.
Unable to get measured results	Finger Is too thin.	Use another finger to measure, ensure the finger covering the blood-oxygen light during the process.

Cautions

Please relax for at least five minutes before measuring. Do not eat, drink alcohol or coffee, exercise, or bathe up to 30 minutes before the measurement.

Please relax as much as possible and do not talk during the measurement procedure.

The health monitor should be placed horizontally during the measurement.

It is recommended to measure with the middle finger, keeping the nails raised. Clean the fingers before the measurement.

DO NOT move the finger during the measurement.

There are some differences in the blood pressure on different fingers, blood circulation, physiological features, hence try to use the same finger to take measurements.

The paralysis state caused by the continuous blood-pressure measurements can influence the blood circulation, which may affect the oximetry values, so do not measure the blood oxygen after finishing the blood pressure measurement.

DO NOT use nail polish on the measuring finger.

DO NOT measure in strong light.

DO NOT measure after exercising.

The measured blood-oxygen value may be incorrect if the tester’s finger skin is too thick or has pigment deposition.

If foreign objects are present between the probe and the parts to be measured, they may
affect the measurement result.

Cold fingertip skin or poor peripheral circulation caused by low temperature treatment or prolonged exposure to low temperature environment can result in insufficient pulse signal, too low measured value or unable to measure.

Instruction for ECG measurement

Power on the device and open the APP. The device can connect to APP automatically or manually with the appearing of electrical quantity icon on APP.
Stay still and calm. Hold the device with your left hand. The thumb should touch the metal ring around the top of the blood oxygen sensor, while the other fingers should touch the metal plate on the back of the device. The power button should face the palm of your hand.
The right hand touches the body temperature sensor. The hands should not touch each other during the measurement process.
Select “ECG” in the App. Click “Start” for the measurement.
The system will stop automatically after the measurement. The measured value will be shown.

Troubleshooting

Malfunctions	Reason	Solution
ECG Diagram Reverse	The position of 2 hands is reverse.	Please place the monitor correctly in both hands, according to the instructions.

Cautions

Please relax for at least five minutes before measuring. Do not eat, drink alcohol or coffee, exercise, or bathe up to 30 minutes before the measurement.
Please relax as much as possible and do not talk during the measurement procedure.
To avoid external disturbance, please do the measurement in a quiet environment.
DO NOT measure during the charging.
Please keep both hands in the correct position.
DO NOT measure with wet hands.
During the measurement, the hands DO NOT touch each other.

Warning – EMC (Electromagnetic Compatibility)

The device requires special precautions regarding electromagnetic compatibility (EMC) and has to be installed and operated in accordance with the EMC information provided in the accompanying documents.
The portable and mobile RF communications equipment can affect the device.
The minimum amplitude or value of PATIENT physiological signal:
Measurement scope of systolic pressure: 60-230 mmHg
Measurement scope of diastolic pressure: 40-130 mmHg
Measurement scope of temperature: 28-42 C
An Operation of the device below this amplitude or value may cause inaccurate results.
Using accessories and cables other than those specified, except for transducers and cables sold by the device manufacturer as replacement parts for internal components, may lead to increased emissions or reduced device functionality.

The device should not be used next to or stacked with other equipment. If it is necessary to use it in such a configuration, the device should be monitored to ensure it operates normally.

Cautions

Please relax for at least five minutes before measuring. Do not eat, drink alcohol or coffee, exercise, or bathe up to 30 minutes before the measurement.
Please relax as much as possible and do not talk during the measurement procedure.
Use the device in the specified environment, otherwise the result might be affected.
Do not use the device in a vehicle while moving.
The result of blood pressure measurement can be affected by the measurement site, the position of the PATIENT, exercise, or the PATIENT’S physiological condition.
The result of blood pressure measurement might be affected by the environment, such as temperature, humidity, and altitude.
Do not measure the same arm continuously. If several measurements are needed, the interval between the two should be more than 30s.
Too frequent blood pressure measurements can cause injury to the PATIENT due to blood flow interference. Inflating the cuff may cause discomfort for the arm during measurement. Do not use it to measure blood pressure for an arm that is injured.
Blood pressure measurement should not be performed on the same arm as other monitoring equipment simultaneously.
The cuff is dedicated to the device. Do not disassemble and replace by yourself. Please contact the manufacturer when needed.
Do not keep the limb pressured by the cuff for a long time. The risk of resulting harm to the arm exists while the cuff is inflating continuously. Please take the device directly off from the cuff if the inflating has not stopped automatically.
When common arrhythmia (e.g., APB, VPBs, AF) appears, measured value may be incorrect, or measurement may be failed.
The high blood pressure referred to is 135/85mmHg.
Keep the forehead clean before the body temperature measures.
Do not allow the detector`s head to contact the skin on the forehead.
Try to measure in a stable environment. Avoid measuring near the air outlet of a fan or air conditioner, and do not place the device in direct sunlight.
Body temperatures can vary depending on the time of day and the body part being measured. A deviation of 0.2°C for the same body part is considered reasonable.

Maintenance

Do not do service and maintenance while the device is in use.
Please do maintenance using the following methods.

Do not wash the cuff with water. Clean with soft and clean fabric.
Do not scrub the device with wet fabric since the device is not waterproof.
Dirty surfaces can be cleaned with a damp cloth, using only water or a neutral detergent. Wring out the cloth well so that it is only damp, not wet. If necessary, you can lightly dab the cloth with ethanol and use it for disinfection.
Keep the device away from fire or heat sources since it contains battery and electronic components.
Calibration is suggested to be conducted every 2 years, although a strict test is finished for each function before delivery. Please contact the manufacturer when a calibration is needed.
Do not disassemble or repair by yourself. Please dial customer service hotline for consultation due to product quality issues or any doubts about measurement results.

Please store the device using the following methods:

Keep the device away from high temperature, moist, direct sunshine, dust, salty air.
Keep the device away from areas where the working position is unstable or where the device could wobble or collide. Keep the device away from places with
chemicals or corrosive gases. Do not drop the device. Do not fold the cuff too tightly.

Repairs

Do not disassemble an repair by yourself. Please dial the customer service hotline +41 (0) 71 510 05 45 for consultation due to product quality issues or any doubts for measurement results. The cuff is specified for the device. Please contact the manufacturer for the repair of an ar purchase. Do not change it by yourself. Any repairs can only be done by authorized people.

Cleaning and disinfection

Clean the device using a soft, dry cloth. If the device is very dirty, you can use water or a neutral cleaning agent but test it on a small area before cleaning. If necessary, you can use degreasing cotton with ethanol for disinfection.

Environmental protection

When disposing of the device, cuff, or waste battery, please follow local regulations. Please do not discard it casually.

After-sales Guarantee

If a malfunction occurs within seven days of purchase, consumers can choose between a refund, exchange, or repair. Free repair is offered for non-accidental artificial damages within two years of purchase. For justified requests outside the timeframe for free exchange or repair, technical service may be provided, which includes the replacement of materials the device is made of, as well as repair and service.
Purchase date is determined by the invoice issued by the manufacturer or authorized dealer.

The guarantee does not apply to the conditions below:

Any non-accidental damage or malfunction caused by using the device in an abnormal working environment, failure to follow the user manual, or using the device under conditions not specified.
Disassembly, repair, or changes to the device by yourself without agreement by the manufacturer.
Damage caused by improper transportation after purchase.
Damage caused by force majeure (e.g., flood, thunder, strike, earthquake, abnormal voltage, etc.).
Normal wear and other conditions affecting normal operation.
Purchase from an unauthorized channel not connected to QluPod. The guarantee is only applicable for the device itself.

Symbol Definition

CATALOGUE NUMBER
MANUFACTURER
KEEP IN A DRY, COOL PLACE
MEDICAL DEVICE COMPLIES WITH DIRECTIVE 93/24/CEE
CONSULT INSTRUCTIONS FOR USE
CAUTION: READ INSTRUCTIONS (WARNINGS) CAREFULLY
AUTHORIZED REPRESENTATIVE IN A EUROPEAN COMMUNITY

DON'T USE IF THE PACKAGE IS DAMAGED
CLASS II APPLIED
FOLLOW INSTRUCTIONS FOR USE
LOT NUMBER
TEMPERATURE LIMIT
KEEP AWAY FRO SUNLIGHT
HUMIDITY LIMIT

EMC Declaration

Guidance and manufacturer’s declaration- electromagnetic emission – for all EQUIPMENT AND SYSTEMS.

Guidance and manufacturer’s declaration – electromagnetic emission.
The HC-031s Intended for use in the electromagnetic environment specified below. The customer or the user of HC-03 should assure that it’s used in such an environment.
Emissions test, Compliance, Electromagnetic environment – guidance.
RF emissions CISPR 11, CLASS 1, The HC-03 uses RF energy only for internal function. Therefore, RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Hannonic emissions IEC 61000-3-2, CLASS B, The HC-03 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 purposes.
Harmonic emissions IEC61000-3-2, CLASS A, The HC-03 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 purposes.
Voltage fluctuations/flickers emissions IEC 81000-3-3, Complies, The HC-03 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 purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS.

Guidance and manufacturer’s declaration – electromagnetic immunity: The HC-03 is intended for use in the electromagnetic environment specified below. The customer or the user of the HC–03 should assure that it is used in such an environment.

Immunity test	EN 60601 test	Compliance	Electromagnetic Environnement
Electrostatic Discharge (ESD) IEC 61000-4-2	± 8 kV contact ± 15 kV air	± 8 kV contact ± 15 kV air	The floor should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrostatic transient burst / IEC 61000-4-4	± 2 kV for power supply lines ± 1 kV for llpuVoutput lines	± 2 kV for power supply lines ± 1 kV for llpuVoutput lines	Main power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	± 1 kV differential mode ± 2 kV c common mode	± 1 kV differential mode ± 2 kV c common mode	Main power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11	<5 % UT (>95 % dip ll UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dp in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec	<5 % UT (>95 % dip ll UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dp in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec	Main power quality should be that of a typical commercial or hospital environment. If the user of the HC-03 requires continued operation during power mains interruptions, it is recommended that the HC-03 be powered from an uninterruptible power supply or a battery.
Power frequency magneticc field (50/60 Hz) IEC 61000-4-6	400 A/m	400 A/m	Power frequency magnetic fields should be at levels typical characteristic location of in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration -electromagnetic immunity- for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING.

Guidance and manufacturer’s declaration – electromagnetic immunity.

The HC-03 is intended for use in the electromagnetic environment specified below. The customer or the user of the HC–03 should assure that it is used in such an environment.

Immunity test	IEC 60601 test level	Compliance Level	Electromagnetical Environment - guidance
Conducted RF IEC 61000-4-6	3 V/m de 150 kHz to 80 MHz	3V (V1)
Radiated RF IEC 61000-4-3	3 V/m de 80 MHz to 2,5 GHz	10V/m(E1)

Immunity test	IEC 60601 test level	Compliance Level	Electromagnetical Environment - guidance
Conducted RF IEC 61000-4-6	3 V/m de 150 kHz to 80 MHz	3V (V1)
Radiated RF IEC 61000-4-3	3 V/m de 80 MHz to 2,5 GHz	10V/m(E1)

NOTE 1 At 80 MHz and 800 MHz. the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetics are affected by absorption and reflection from structures, objects, and people.

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 HC-03 is used exceeds the applicable RF compliance level above, the HC-03 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HC-03.

b.) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [Vl] v/m.

Recommended separation distances between portable and mobile RF communications EQUIPMENT or SYSTEM for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING.

Recommended separation distances between portable and mobile RF Communications equipment and the HC-03.

The HC-03 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HC-03 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HC-03 as recommended below, according to the maximum output power of the communications equipment.

	Separation distance according to frequency of transmitter (m)	Separation distance according to frequency of transmitter (m)	Separation distance according to frequency of transmitter (m)
Rated maximum output of transmitter (W)
0.01	0.12	0.12	0.23
0 01	0.38	0.38	0.73
1	1.2	1.2	2.3
10	3.8	3.8	7.3
100	12	12	23

	Separation distance according to frequency of transmitter (m)	Separation distance according to frequency of transmitter (m)	Separation distance according to frequency of transmitter (m)
Rated maximum output of transmitter (W)
0.01	0.12	0.12	0.23
0 01	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 distanced 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 (w) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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 and people.

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