Jamr F1703T Blood Pressure Monitor User Manual

Jamr F1703T Blood Pressure Monitor

Introduction and Intended Use

• The device is a fully automatic digital blood pressure measuring device using oscillometric technique to measure systolic and diastolic blood pressure as well as the pulse for adults that ages are more than 12 years old by wrapping around the upper arm with cuff circumference ranging from 22 cm to 42 cm.
• The device can be used in medical facilities or at home, and only for indoor use.
• Contraindication: The device is not used for patients under dialysis therapy or on anticoagulants, antiplatelets, or steroids.
• The device provides accurate blood pressure measurement values that are effective and suitable for clinical and home use.
• Before using, please read this instruction manual carefully and then keep it in a safe place.

Remember

• Only a healthcare professional is qualified to interpret blood pressure measurements.
• This device is NOT intended to replace regular medical checkups.
• The device is intended for use by adults only and not intended for use on children and pregnant patients. The effectiveness has not been established in pregnant (including pre-eclamptic) patients.
• In cases of irregular heartbeat, measurements made with this instrument should only be evaluated after consultation with a physician.
• The products, including accessories, shall be processed by local regulations after reaching the life cycle.
• Any serious incident that has occurred about the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Warnings and Precautions

• Warning: Do not use the AC adapter if the unit or the power cord is damaged. Turn off the power and unplug the power cord immediately.
• Warning: The device is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide.
• Warning: If the patient is an intended operator, the functions of monitoring blood pressure and pulse rate can be safely used by the patient. The routine cleaning and changing of batteries can be performed by the patient.
• Warning: The device provides a DC input port connected to an external AC adapter. It is recommended that use the adapter specified by the manufacturer. The adapter should meet the following conditions: class equipment, output voltage: DC 5V, current: ≥1A, and comply with IEC 60950, IEC 60601-1 or IEC 62368-1, provide at least two MOOP insulation between AC input and output. External adapter connected to medical electrical equipment through the DC input port must comply with the respective IEC or ISO standards (e.g. IEC 60950 or IEC 62368-1 for data processing equipment). Furthermore, all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, 60601-1-2, respectively). Anybody connecting an external adapter to medical electrical equipment configurations a medical system and is therefore responsible for that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above-mentioned requirements. If in doubt, consult your local representative or the technical service department.
• Warning: Too frequent measurements can cause injury to the PATIENT due to blood flow interference.
• Warning: Don’t place the cuff over the wound part.
• Warning: Pressurization of the CUFF can temporarily cause loss of function of simultaneously used monitoring ME EQUIPMENT on the same limb.
• Warning: Regularly check the operation of the blood pressure monitor to ensure that it does not cause long-term damage to the patient’s blood circulation.
• Warning: Apply CUFF and its pressurization on the side of the patient’s mastectomy or lymph node removal can cause injury.
• Warning: To avoid any possibility of accidental strangulation, keep this device away from children, and do not drape tubing around your neck.
• Caution: The user must check that the equipment functions safely and see that it is in proper working condition before being used.
• Caution: To avoid damaging the device, keep this unit away from children and pets.
• Caution: The standard material used for the bladder and tubing is latex-free.
• Caution: The device is intended to monitor, not to diagnose. Unusual values have to be always discussed with a physician. Under any circumstance, you should not alter the dosages of any drugs prescribed by a physician.
• Caution: The device cannot be used to substitute the professional ECG monitor device for monitoring the frequency of heartbeat.
• Caution: This device can not be used together with HF surgical equipment.
• Note: To obtain the greatest accuracy from your blood pressure monitor, it is recommended that the instrument be used within the specified temperature and the relative humidity, please see the Technical Specifications.
• Note: The device can not be used in an MRI environment.
• Note: The cuff is defined as the applied part. The user should contact the manufacturer for assistance, if needed, to replace, or maintain the device.
• Note: This device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens) during use. These can lead to erratic results.
• Note: Do not attempt to service or repair this device yourself. Should a malfunction occur, refer to the local distributor or the manufacturer.

Important Information on Blood Pressure and its Measurement

• How does high or low blood pressure arise?
  • Your level of blood pressure is determined in the circulatory center of the brain and adjusts to a variety of situations through feedback from the nervous system.
  • To adjust blood pressure, the strength and speed of the heart (Pulse), as well as the width of circulatory blood vessels, is altered.
  • Blood vessel width is controlled by fine muscles in the blood vessel walls.
  • Your level of arterial blood pressure changes periodically during heart activity: During the “blood ejection” (Systole) the value is highest (systolic blood pressure value).
  • At the end of the heart’s “rest period” (Diastole) pressure is lowest (diastolic blood pressure value).
• Which values are normal?
  • Please refer to the diagram below (Picture-01)
  • There are six grids in the display of the device. Please refer to the Picture-01-01.
  • Different grids represent different interval scales of WHO.
    Blood pressure value| WHO grids in device| WHO Classification
    ---|---|---
    DIA<80 & SYS <120| 1| Optimal blood pressure
    DIA<85 & SYS <130| 2| Normal blood pressure
    DIA<90 & SYS <140| 3| High normal value
    DIA<100 & SYS <160| 4| Mild hypertension
    DIA<110 & SYS <180| 5| Moderate hypertension
    DIA>=110 or SYS >=180| 6| Severe hypertension

Picture-01-01

1. Results in grades 1 to 3 will be displayed in WHITE.
2. Results in grades 4 to 5 will be displayed in ORANGE.
3. Results in grade 6 will be displayed in RED.

Components of Your Blood Pressure Monitor

Measuring unit

The symbols on the LED display

1. USER 1
2. USER 2
3. Bluetooth symbol
4. Movement error symbol
5. Irregular heartbeat symbol
6. Cuff wrap correct symbol
7. Cuff wrap error symbol
8. Mute symbol
9. Low battery symbol
10. Date/Time display
11. PM symbol
12. AM symbol
13. Memory symbol
14. Average value symbol
15. Pulse display / Memory number
16. Systolic blood pressure
17. Heartbeat symbol (Flashes during measurement)
18. Diastolic blood pressure
19. WHO symbol

Features of Model F1703T

1. 1. Voice function
2. Double users: 2 x 120 sets memory
3. Cuff self-checking function
4. Irregular heartbeat checking
5. Average value function
6. Low battery display
7. WHO function
8. Auto power-off
9. External power adapter support
10. Volume adjustment
11. Date/time display
12. Bluetooth function
13. 3-color result reading to indicate different blood pressure levels.”

Using your Monitor for the First Time

Activating the pre-installed batteries Battery Installation

Use only 1.5V “AA” alkaline batteries with this device.

1. Press the hook on the bottom of the battery cover and lift the cover off in the direction of the arrow (Picture-04).
2. Install 3 “AA” size batteries and make sure the + (positive) and – (negative) polarities match the polarities of the battery compartment, then close the battery cover. Make sure that the battery cover is securely in position.

Battery replacement

Low Battery Indicator

1. When the Low Battery Indicator appears on the display, turn the monitor off and remove all the batteries. Replace with 3 new batteries at the same time. Long-life alkaline batteries are recommended.
2. To prevent damage to the monitor from leaked battery fluid, please take out of the battery if the monitor is unused for a long time(generally more than 3 months). If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Contact a physician immediately.
3. Dispose of the device, components, and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

System Settings

• After you load the battery or connect power for the monitor, long press the SET button for more than 3s, and then you can start to set it.

Setting the User ID(1 or 2)

• With the unit off, Press the ( ) button to display the current user. then you can switch the User ID by pressing the Users button.

Setting the Brightness

• With the unit off, Press the ( ) button to display the current Brightness. then you can switch the adjust it by pressing the ( ) button. Gears 1 through 3 get brighter.

Setting the volume

• Push the ( ) button to adjust the volume in 3 levels， The volume increases gradually from the bottom to the top.

Setting the Year/Month/Date/Hour system/Time Setting the Year

• When the year display is flashing, press the ( ) button continuously and it will increase continuously 1 by 1 until 2049, and then return to the original year, Press the ( ) button continuously and it will reduce continuously 1 by 1, once the year set is OK, press the ( ) button to confirm.

Setting the Month

• Initial Month/Date is 1/01, when the Month display is flashing, press the ( ) button continuously, and the month will increase continuously 1 by 1, press the ( ) button continuously and it will reduce continuously 1 by 1, press the ( ) button to confirm, and do in the same way to set the date,
• Press the ( ) button to confirm.

Setting Time

• When the hour display is flashing, press the ( ) button continuously, and the hour will increase continuously 1 by 1, press the ( ) button continuously and it will reduce continuously 1 by 1, press the ( ) button to confirm, and do in the same way to set the minute. Press the ( ) button to confirm.

Setting hour system

• The initial hour system is 12 hours, press the ( ) button or ( ) button, and then you can switch 12 or 24-hour system, press the ( ) button to confirm.

Setting Time

• When the hour display is flashing, press the ( ) button continuously, and the hour will increase continuously 1 by 1, press the ( ) button continuously and it will reduce continuously 1 by 1, press the ( ) button to confirm, and do in the same way to set the minute.
• Press the ( ) button to confirm.
• Note: After the device is powered off, and then reload the battery. The monitor will display the Setting interface.

Memory

• Each unit stores 120 sets of measurements for 2 users, a total of 240 sets (User 1 and 2).
• Measurements for each user are stored separately. Be certain that you are viewing the measurements for the correct user.

View the memory

• With the unit off, press the ( ) button. The monitor will display the User ID and an average value of the last 3 times measurements stored in the unit. (If measurements are less than 3 sets, directly display the first set )
• Each time you press the ( ) button, it will display the memory value from the latest to the oldest in turn.
• Each time you press the ( ) button, it will display the memory value from the oldest to the latest in turn.

Switch user memory

• When viewing the memory, press the ( ) button, and it will switch the User ID, and then display another user memory value

Cuff tube connection

• Insert the cuff tube into the opening on the left side of the monitor indicated by the drawing of a cuff.

Measurement Procedure

Before measurement

• Avoid eating and smoking as well as all forms of exertion directly before measurement. These factors influence the measurement result.
• Find time to relax by sitting in an armchair in a quiet atmosphere for about ten minutes before taking a measurement.
• Remove any garment that fits closely to your upper arm.
• Always measure on the same arm (normally left).

Fitting the Cuff

Please refer to picture-05

1. Wrap the cuff around your upper left arm. The rubber tube should be on the inside of your arm extending downward to your hand. Make certain the cuff lies approximately 2 to 3 cm above the elbow. Important! The edge of the cuff (Artery Mark) must lie over the artery that runs down the inner side of the arm.
2. To secure the cuff, wrap it around your arm and press the hook and loop closure together.
3. There should be little free space between your arm and the cuff. You should be able to fit 2 fingers between your arm and the cuff. Cuffs that don’t fit properly result in false measurement values. Measure your arm circumference if you are not sure of the proper fit.
4. Lay your arm on a table (palm upward) so the cuff is at the same height as your heart. Make sure the tube is not kinked.

Measure Procedure

The device is designed to take measurements and store the measurement values in memory for two people using User ID 1 and User ID 2. Refer to picture-06

1. Sit comfortably in a chair with your feet flat on the floor.
2. Select your User ID (1 or 2).
3. Stretch your arm forward on the desk and keep relaxing, making sure the palm of your hand is upturned. Make sure the arm is in the correct position, to avoid body movement. Sit still and do not talk or move during the measurement. After the cuff has been appropriately positioned on the arm and connected to the blood pressure monitor, the measurement can begin:

NOTE Patient Position:

1. Comfortably seated
2. Legs uncrossed
3. Feet flat on the floor
4. Back and arm supported
5. Middle of the CUFF at the level of the right atrium of the heart

Operate via the App on smartphone with Bluetooth

1. Install the App from the Google play store or the Apple app store. Open Bluetooth on a smartphone, and then turn on the App.
2. Bluetooth pairing Turn on the device and the Bluetooth symbol ( ) will flash, Then operate bluetooth pairing according to the Settings on the APP, The Bluetooth symbol ( ) will stop flashing after the Bluetooth pairing is successful.
3. Bluetooth will be automatically searched and connected when it is powered on. After the Bluetooth connection is successful, the Bluetooth symbol ( ) will stop flashing and the measurement data will be uploaded to the APP.

Note: Devices that have been successfully paired will save the pairing information and do not need to be paired again. It is recommended to connect the APP through Bluetooth before each measurement and then start the measurement.

Operate on the device

1. Press the START/STOP button. The pump begins to inflate the cuff. In the display, the increasing cuff pressure is continually displayed.
   • Note: If the voice is playing, you can skip the voice by pressing the MEM button or SET button before the pump begins to inflate the cuff.
2. After automatically reaching an individual pressure, the pump stops and the pressure falls. The cuff pressure is displayed during the measurement.
3. When the device has detected your pulse, the heart symbol in the display begins to blink.
4. When the measurement has been concluded, the measured systolic and diastolic blood pressure values, as well as the pulse will be displayed.
5. The measurement results are displayed until you switch the device off. If no button is pressed for 60 seconds, the device switches off automatically.
6. Cuff self-checking symbol ( ) The cuff correct symbol( ) will be displayed if the cuff position is correct, otherwise the wrong symbol( ) will be displayed. Please check again the cuff if the wrong symbol( ) is displayed.
7. Movement error symbol ( ) The Movement error symbol ( ) is displayed if you move your body during the measurement. Please remove the cuff, and wait 2-3 minutes. Reapply the cuff and take another measurement.

Irregular Heartbeat Detector

• This symbol ( )-indicates that certain pulse irregularities were detected during the measurement.
• In this case, the result may deviate from your normal basal blood pressure – repeat the measurement. Information for the physician on the frequent appearance of the Irregular Heartbeat Symbol.
• This instrument is an oscillometric blood pressure monitor device that also analyzes pulse frequency during measurement. The instrument is clinically tested.
• If pulse irregularities occur during measurement, the irregular heartbeat symbol is displayed after the measurement. If the symbol appears more frequently (e.g. several times per week on measurements performed daily) or if it suddenly appears more often than usual, we recommend the patient to seek medical advice. The instrument does not replace a cardiac examination but serves to detect pulse irregularities at an early stage.

Error Indicates

The following symbol will appear on the display when measuring abnormal

with new ones. Check the battery installation for proper placement of the battery polarities.
Er 1| Sensor abnormal| Check if the pump is working or not. If it is working, then the problem is sensor abnormal. Please send it to the local distributor.
Er 2| The monitor could not detect pulse waves or cannot calculate the blood pressure data| to start the measurement again. If the error is still displayed, please send it to the local distributor
Er 3| The measurement result is abnormal| Occasionally measure for one more time/Always send it to the local distributor
Er 4| Too loose cuff or air leakage| Tie the cuff correctly and make sure the air plug is properly inserted into the unit
Er 5| The air tube is crimped or the cuff is tied too tight| Correct it and make the measurement again
Er 6| The sensor is sensing great fluctuation in the pressure| Please keep quiet and don’t move
Er 7| The pressure that the sensor senses is over the limit| Start the measurement again. If the error is still displayed, please send it to the local distributor

Er 8

| The demarcation is incorrect or the device has not been demarcated| Please send it back to the local distributor
HI| The pulse rate exceeds the upper limit (>199 per minute)| Beyond the measurement range, a normal reminder
LO| The pulse rate is less than the lower limit (<40 per minute)| Beyond the measurement range, a normal reminder

Trouble removal

battery’s polarities
No inflation| Whether the plug insert| Insert into the air socket tightly
Whether the plug broken or leak| Change a new cuff
Err and stop working| Whether move the arm when inflating| Keep the body peaceful
Check if chatting when measured| Keep quiet when measuring
Cuff leak| Whether the cuff wrap is too loose| Wrap the cuff tightly
Whether the cuff broken| Change a new cuff
Please contact the distributor if you can’t solve the problem, do not disassemble the unit by yourself!

SYMBOL DESCRIPTIONS

The following symbols may appear in this manual, on the Blood Pressure Monitor F1703T, or its accessories. Some of the symbols represent standards and compliance associated with the Blood Pressure Monitor F1703T and its use.

Delete memory

• In average value memory viewing mode, the average value symbol ( AVG) is being displayed, long press the ( ) button for 3 seconds, and then it will display DEL ALL.
• Press the ( ) and ( ) buttons to confirm to delete all memories for the current user. If you do not want to delete, you can press the ( ) to exit delete in the (DEL ALL )interface
• In single-set memory viewing mode, long press the( )button for 3 seconds, and then it will display DEL ONE. Press the ( ) and ( ) button to confirm to the memory being displayed.
• If you do not want to delete, you can press the ( ) to exit delete in the (DEL ONE )interface.

NOTE: Taking the battery out won’t lead to a memory missing.

Discontinuing a Measurement

• If it is necessary to interrupt a blood pressure measurement for any reason (e.g. the patient feels unwell), the Start/Stop button can be pressed at any time.
• The device then immediately lowers the cuff pressure automatically.

Using the AC Adapter

You may also operate this monitor using the AC adapter (output 5V DC 1A with Type C connector).

1. Ensure that the AC adapter and cable are not damaged.
2. Plug the adapter cable into the AC adapter port on the right side of the blood pressure monitor.
3. Plug the adapter into your electrical outlet. When the AC adapter is connected, no battery current is consumed.

Note : No power is taken from the batteries while the AC adapter is connected to the monitor. If electrical power is interrupted,(e.g., by accidental removal of the AC adapter from the outlet) the monitor must be reset by removing the plug from the socket and reinserting the AC adapter connection.

Care and Maintenance

Wash hands after each time measurement. If one device is used by different patients, wash hands before and after each use.

1. Do not expose the device to extreme temperatures, humidity, dust, or direct sunlight.
2. The cuff contains a sensitive air-tight bladder. Handle this cuff carefully and avoid all types of stress through twisting or buckling.
3. Clean the device with a soft, dry cloth. Do not use gas, thinners, or similar solvents. Spots on the cuff can be removed carefully with a damp cloth and soapsuds. The cuff with the bladder must not be washed in a dishwasher, clothes washer, or submerged in water.
4. Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp edges.
5. Do not drop the monitor or treat it roughly in any way. Avoid strong vibrations.
6. Never open the monitor! This invalidates the manufacturer’s warranty.
7. Batteries and electronic instruments must be disposed of by the locally applicable regulations, not with domestic waste.

Accuracy test

Sensitive measuring devices must be checked for accuracy from time to time. We recommend a periodical inspection of your unit by an authorized dealer every 1 year. Please turn to the local distributor or the manufacturer.

Warranty/ Service

• Your blood pressure monitor is guaranteed for 1 year against manufacturers’ defects for the original purchaser only, from the date of purchase.
• The warranty does not apply to damage caused by improper handling, accidents, professional use, not following the operating instructions, or alterations made to the instrument by third parties.
• The warranty only applies to the main device and its cuff. All other accessories are not covered by warranty.
• There are no user-serviceable parts inside. Batteries or damage from old batteries is not covered by the warranty.

Certifications

• Device standard:
  • This device is manufactured to meet the blood pressure monitors: IEC 80601-2-30 / IEC60601-1-11 / IEC60601-1
  • Electromagnetic compatibility: The device fulfills the stipulations of the International standard IEC60601-1-2

The device was clinically investigated and the safety and efficacy meet the requirement of ISO 81060-2. If you need to acquire a copy of the summary of the Clinical Investigation, please contact the manufacturer.

FCC

FCC Statement

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.

This equipment has been tested and found to comply with the limits for a Class B digital device, under part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used by 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 to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co‐located or operating in conjunction with any other antenna or transmitter.

Technical Specifications

Humidity: 15% to 90% RH;
Storage And Shipping Conditions| Temperature: -20℃ to 60℃;
Humidity:10%RH~93%RH;
Atmospheric pressure range| 70kPa~106kPa
Measuring method| Oscillometric
Pressure sensor| Resistive
Measuring range| DIA: 40-220mmHg; SYS: 60-260mmHg
Pulse: 40 to 199 per minute
Cuff pressure display range| 0-295mmHg
Memory| Automatically stores the last 120 measurements for 2 users (total 240)
Measuring resolution| 1 mmHg
Accuracy| Pressure within ± 3 mmHg / pulse ± 5 % of the reading
Power source| 3*AA batteries, 4.5 V AC adapter INPUT: a.c. 100-240V 50/60HZ OUTPUT: d.c. 5V 1A
Automatically power off| 60 seconds
Users| Adult
Packaging list: 1×Main Device, 1×Cuff, 1×User manual, 1×Warranty card
The expected service life of the device and accessories: 5 years
Technical alterations reserved!

EMC Declaration

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.

• Warning: Don’t near active HF surgical equipment and the RF-shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• Warning: 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.
• Warning: Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
• Warning: 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 Blood Pressure Monitor (F1703T), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• If any: a list of all cables and maximum lengths of cables (if applicable), transducers, and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
• If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term “ESSENTIAL 11 EMC Declaration PERFORMANCE” need not be used).

Technical description

1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE about electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| Group 1
RF emissions CISPR 11| Class B
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Applied

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Test frequency| Modulation| IMMUNITY TEST LEVEL (A/m)
30 kHz| CW| 8
134,2 kHz| Pulse modulation b) 2,1 kHz| 65 c)
13,56 MHz| Pulse modulation b) 50 kHz| 75 c)
a) This test applies only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.

c) r.m.s., before modulation is applied.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transient/burst IEC 61000-4-4| Power supply lines：±2 kV input/output lines：±1 kV 100 kHz repetition frequency| Power supply lines：±2 kV
Surge IEC 61000-4-5| line(s) to line(s)：±0.5 kV line(s) to earth：±2 kV line(s) to lines(s): ±1 kV| line(s) to line(s)：±0.5 kV line(s) to line(s)：±1 kV.
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11| 0% 0.5 cycle At 0º, 45 º, 90 º, 135 º, 180 º, 225 º, 270 º and 315 º 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle| 0% 0.5 cycle At 0º, 45 º, 90 º, 135 º, 180 º, 225 º, 270 º and 315 º 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle
Power frequency magnetic field IEC 61000-4-8| 30 A/m 50Hz/60Hz| 30 A/m 50Hz/60Hz
Conducted RF IEC61000-4-6| 150KHz to 80MHz： 3Vrms 6Vrms (ISM and amateur radio bands) 80% Am at 1kHz| 150KHz to 80MHz： 3Vrms 6Vrms (ISM and amateur radio bands) 80% Am at 1kHz
Radiated RF IEC61000-4-3| 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

Proximity magnetic fields IEC 61000-4-39| 30 kHz: 8A/m

134.2 kHz: 65A/m

13.56 MHz: 7.5A/m

| 30 kHz: 8A/m

134.2 kHz: 65A/m

13.56 MHz: 7.5A/m

NOTE 1: UT is the a.c. mains voltage before application of the test level.

Table 4

CONTACT INFORMATION

• Shenzhen Jamr Technology Co., Ltd.
• A101-301, D101-201, Jamr Science & Technology Park, No. 2
• Guiyuan Road, Guixiang Community, Guanlan Street, Longhua
• District, 518100 Shenzhen, PEOPLE’S REPUBLIC OF CHINA
• Shanghai International Holding Corp. GmbH (Europe)
• Eiffestrasse 80, 20537 Hamburg, Germany
• shholding@hotmail.com.
• Published Date: 2024/5/27
• Version Number: 1.0
• Model Number: F1703T

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