Jamr B21H, B21HT Blood Pressure Monitor User Manual

Jamr B21H, B21HT Blood Pressure Monitor

Product Information

Specifications:

• Product: Blood Pressure Monitor
• Model Number: B21H/ B21HT
• Manufacturer: Shenzhen Jamr Technology Co., Ltd.
• Version Number: 1.0

Introduction and Intended Use:
The blood pressure monitor is designed to measure blood pressure and pulse rate accurately. It is intended for personal use to monitor and track blood pressure levels.

Warnings and Precautions:

• Use only specified accessories provided by the manufacturer.
• Avoid using the device in extreme temperature or humidity conditions.
• Ensure the device is functioning properly before each use.
• Avoid using the device in the presence of flammable substances.
• Avoid using the device with HF surgical equipment.
• Do not place the cuff over a wound.
• Avoid frequent measurements to prevent blood flow interference.

Important Information on Blood Pressure and its Measurement:

• How does high or low blood pressure arise?
  Blood pressure is regulated by the circulatory center of the brain, adjusting based on feedback from the nervous system. Changes in heart strength, pulse rate, and blood vessel width affect blood pressure levels.

• Which values are normal?
  Refer to the provided diagram (Picture-01) for normal blood pressure values. Systolic and diastolic blood pressure values vary during heart activity, with optimal values falling within a specific range.

Product Usage Instructions

1. Place the cuff on your arm as instructed in the user manual.
2. Sit in a relaxed position with your arm supported at heart level.
3. Press the start button to begin the measurement process.
4. Remain still and quiet during the measurement.
5. Record the displayed blood pressure and pulse rate readings for reference or tracking.

FAQ :

• Q: Can the blood pressure monitor be used by multiple users?
  A: It is recommended that each user has their own designated cuff for accurate measurements and tracking of individual data.

• Q: How often should I calibrate the blood pressure monitor?
  A: Calibration frequency may vary depending on usage, but it is generally recommended to calibrate the device annually or as advised by the manufacturer.

Blood Pressure Monitor
Model Number: B21H/B21HT
USER’S MANUAL

• Shenzhen Jamr Technology Co., Ltd.
  A101-301, D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community, Guanlan Street, Longhua District, Shenzhen 518100, PEOPLE’S REPUBLIC OF CHINA
  Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany.

• Version Number:1.0

Introduction and Intended Use

This manual is for B21H/B21HT models. It is a fully automatic digital blood pressure
It enables reliable measurement of systolic and diastolic blood pressure as well as pulse through the oscillometric method.
The device is used for adult that age is more than 12 years old ,and the intended populations are the patients with hypertension or need blood pressure monitoring. The device can be used in medical facilities or at home, and only for indoor use.
Before using, please read this instruction manual carefully and then keep it in a safe place.

1. Remember
   • Only a health-care professional is qualified to interpret blood pressure measurements.
   • This device is NOT intended to replace regular medical checkups.
   • Blood pressure readings obtained by this device should be verified before prescribing or making adjustments to any medications used to control hypertension. Under no circumstances should  YOU alter the dosages of any drugs prescribed by your doctor.
   • This monitor is intended for use by adults only. Consult with a physician before using this instrument on a child.
   • In cases of irregular heartbeat, measurements made with this instrument should only be evaluated after consultation with your doctor.
   • Host products, including accessories, shall be processed in accordance with local regulations after reaching the life cycle.
2. Warnings and Precautions
   • Warning: The use of other accessories other than those specified or provided by the equipment manufacturer may cause electromagnetic radiation to increase or decrease electromagnetic immunity resulting in operational failure.
   • Warning: This system may fail to yield specified measurement accuracy if operated or stored in temperature or humidity conditions outside the limits stated in the specifications section of this manual.
   • Warning: The user must check that the equipment functions safely and see that it is in proper working condition before being used.
   • 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 patient. The routine clean and changing batteries can be performed by the patient.
   • Warning: This device can not be used together with hf surgical equipment.
   • Warning: The device provides a DC input port connected to external ac adapter. It is recommended that use the adapter specified by the manufacturer. The adapter should meet the following   conditions: class II 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 dc 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). Further more 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 external adapter to medical electrical equipment configurations a medical system and is therefore responsible 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 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 checking 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.
   • Caution: To avoid any possibility of accidental strangulation, keep this device away from children and do not drape tubing around your neck.
   • 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.
   • Attention: The device is intended for monitoring, and not for a diagnsis. Unusual values must always be discussed with a physician. Under no circumstances should you alter the dosages of any drugs prescribed by a physician.
   • Attention: The device cannot be used to substitute the professional ECG monitor device for monitoring the frequency of heart beat!
   • Attention: In cases of irregular heartbeat, measurements made with this instrument should only be evaluated after consultation with a physician.
   • Note: To obtain the greatest accuracy from your blood pressure instrument, it is recommended that the instrument be used within the specified temperature and the relative humidity, please see the Technical Specifications.
   • Note: The cuff is defined as the applied part. The user should contact the manufacturer for assistance, if needed, replace, or maintaining 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 local distributor or the manufacturer.

Important Information on Blood Pressure and its Measurement

1. 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).
2.  Which values are normal?
   • Please refer to the diagram below(Picture-01)
   • Diastolic blood
   • There are six grids in the display of device. Please refer to the picture-01-01. Different grids represent different interval scales of WHO.

 Components of your blood pressure monitor

1. Measuring unit
2. The symbols on the LCD display
3. WHO Function symbol ;
4. Diastolic blood pressure ;
5. Heartbeat symbol (Flashes during measurement);
6. Pulse display/Memory number ;
7. Memory symbol ;
8. Movement error symbol;
9. Date/Time display;
10. Voice on or mute symbol;
11. USER 1
12. Pulse unit symbol;
13. Average value symbol ;
14. Irregular heartbeat symbol;
15. Cuff self-checking function ;
16. Battery low symbol;
17. USER 2
18. Systolic blood pressure
19. Features of Model B21H/B21HT
20. Talking function
21. Cuff self-checking function
22.  Average value function
23.  WHO function
24.  External power adapter support 11. Date/time display
25.  Double users: 2 x 120 sets memory 4. Irregular heartbeat checking
26.  Low battery display
27. Auto power-off
28. Volume adjustment

 Using your Monitor for the First Time

System Settings
After you load the battery or connect power for the monitor

• Setting the Users

  • Press the and then you can set the A/B user

  • Setting the Year/Month & Date/Time/Volume

  • Long press the  button for more than 3s, and then you can start to set.

  • Setting the Year:
    When the year display is flashing, press the    button Adjust , the year will reduce or increase by 1, once the year Setting is OK  , press the button to confirm.

  • Setting Month/Date:
    Initial Month/Date is 1/01, when the Month display is flashing, press the button Adjust , the month will reduce or increase 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, the hour will reduce or increase by 1, press the  button to confirm, and do in the same way to set the minute, press the  button to confirm

• Setting Volume:

1. When display with SP is flashing, press the   button to switch volume  1, volume 2, volume 3 or OFF, press the button to confirm.
2.  **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).
  • Always compare measurements taken at the same time of day, since blood pressure changes during the course of the day, as much as 20-40 mmHg.

• Fitting the Cuff
  Please refer to picture-04

  • The cuff is preformed for easier use. Remove tight or bulky clothing from your upper arm.
  • 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 2to3 cm) above the elbow. Important! The on the edge of the cuff (Artery Mark) must lie over the artery which runs down the inner side of the arm.
  • To secure the cuff, wrap it around your arm and press the hook and loop closure together.
  • 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 proper fit.
  • 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.
  • Remain seated quietly for at least two minutes before you begin the  measurement.

Measure Procedure

Refer to picture 05
The monitor is designed to take measurements and store the measurement values in memory for two people using User ID 1 and User ID 2.

1. Sit comfortably in a chair with your feet flat on the floor.

2. Select your User ID (1 or 2).
   Stretch your arm forward on the desk and keep relaxing, make sure the palm of hand is upturned. Make sure arm is in 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:

3. Operate via the App on smart phone with Bluetooth

   • Install the App from Google play store or Apple app store. Open Bluetooth on smart phone, and then turn on the App.

   • 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.

   • When the Bluetooth-paired device is turned on, it will automatically searches for Bluetooth and try to connect the APP. After the Bluetooth connection is successful, the Bluetooth symbol will stop flashing and the measurement data will be uploaded to the APP.

4. 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

5. Operate on the device

   • Press the Stop/Start 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 button before the pump begins to inflate the cuff.
   • After automatically reaching an individual pressure, the pump stops and the pressure slowly falls. The cuff pressure is displayed during the measurement.
   • When the device has detected your pulse, the heart symbol in the display begins to blink.
   • When the measurement has been concluded, the measured systolic and diastolic blood pressure values, as well as the pulse will be displayed.
   • The measurement results are displayed until you switch the device off. If no button is pressed for 60seconds, the device switches off automatically.
   • Cuff self-checking symbol
   • 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.

Recommended Use Methods

1. recommendation that the PATIENT relax as much as possible and not talk during the measurement PROCEDURE
2. recommendation that 5 min should elapse before the first reading is taken
3. any reading can be affected by the measurement site, the position of the PATIENT, exercise, or the PATIENT’S physiologic condition
4. performance of the AUTOMATED SPHYGMOMANOMETER can be affected by extremes of temperature, humidity and altitude
5. To stop the inflation or measurement, push the START/STOP button. The  monitor will stop inflating, start deflating, and will turn off.
6. After the monitor has detected your blood pressure and pulse rate, the cuff automatically deflates. Your blood pressure and pulse rate are displayed.
7. The monitor will automatically turn off after one minute

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 doctor on 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| Monitor could not detect pulse wave or cannot calculate the blood pressure data| Please wear cuff correctly and measure again. If the error is still displayed, please send it to local.
Er 3| Measurement result is abnormal| Occasionally-measure for one more time/ Always – send it to local distributor
Er 4| Too loose cuff or air leakage| Tie the cuff correctly and make sure the air plug is properly inserted in the unit
Er 5| The air tube is crimped| 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 sensing is over the limit| Please send back to the local distributor
Er 8| The demarcation is incorrect or the device has not been demarcated| Please send back to the local distributor
HI| The pulse rate exceeds the upper limit (＞199 per minute）| Beyond the measurement range, normal reminder
LO| The pulse rate is less than the lower limit (＜40 per minute）| Beyond the measurement range, normal reminder

Trouble removal

batteries 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 inflate| Keep the body peaceful
Check if chatting when measured| Keep quite when measure
Cuff leak| Whether the cuff wrap 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 Digital Blood Pressure Monitor B21H/B21HT, or on it’s accessories. Some of the symbols represent standards and compliances associated with the Digital Blood Pressure Monitor B21H /B21HT and its use.

Memory
At the end of a measurement, this monitor automatically stores each result with date and time. Each unit stores 120 sets measurements for 2 users, totally 240 sets ( User 1 and 2 ). Be certain that you are viewing the measurements for the correct user.

• Viewing the stored values
  With the unit off, press the ( ) button. The monitor will display 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 )
  Press the ( ) button to query different measurements.

• Delete memory

• In average value memory viewing mode, the average value symbol (AVG) ) is  being displayed, long press the (    ) button for 3 seconds , then it will delete  all measurements for the current user.
  In single set memory viewing mode, long press the ( ) button for 3 seconds , then it will delete only a set measurement being displayed.

• Note : If you decide to delete the all record, please keep the record in another way, in case you need it some days later. Take the battery out won’t lead to a record 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.

• Battery Change Indicator
  Batteries discharged– replacements required
  When the batteries are discharged, the battery symbol will flash as soon as the instrument is switched on. You cannot take any further measurements and must replace the batteries.
  The battery compartment is located on the back side of the unit

  • Remove cover from the bottom plate, as illustrated below picture-06
  • Insert the batteries (3 x size AA ). Always use AA long life batteries or alkaline 1.5V batteries.
  • The memory retains all values although date and time must be reset – the year number therefore flashes automatically after the batteries are replaced.
  • To set date and time, follow the procedure described in Section 4.2.

• Which batteries and which procedure?

• Use three new, longlife 1.5V AA batteries. Do not use batteries beyond their expiration date. If the monitor is not going to be used for a prolonged period the batteries should be removed.

• Using rechargeable batteries

• You can also operate this instrument using rechargeable batteries.

  • Only use “NiMH” reusable batteries!
  • If the battery symbol the batteries must be removed and recharged! They must not remain inside the instrument, as they may become damaged through total discharge even when switched off. The batteries must NOT be discharged in the blood pressure monitor! If you do not intend to use the instrument for a week or more, always remove the rechargeable batteries!
  • Recharge these batteries using an external charger and follow manufacturer’s instructions Carefully.

Using the AC Adapter
You may also operate this monitor using the AC adapter (output d.c.5V 1A with TYPE-C plug).
Use only the approved AC adapter to avoid damaging the unit (class II).

• Ensure that the AC adapter and cable are not damaged.
• Plug the adapter cable into the AC adapter port on the right side of the blood pressure monitor.
• 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.

• Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight.
• The cuff contains a sensitive air-tight bubble. Handle this cuff carefully and avoid all types of stress through twisting or buckling.
• 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 bladder must not be washed in a dishwasher, clothes washer, or submerged in water.
• Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp edges.
• Do not drop the monitor or treat it roughly in any way. Avoid strong vibrations.
• Never open the monitor! This invalidates the manufacturer’s warranty.
• Batteries and electronic instruments must be disposed of in accordance with 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 years. Please turn to local distributor or the manufacturer.

 Warranty/Service

Your blood pressure monitor is guaranteed for 1 years against manufacturers’ defects for the original purchaser only, from 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. Warranty only applies to the instrument. All accessories including the cuff are guaranteed for one year, TYPE-C charging cable is not included. There are no user serviceable parts inside. Batteries or damage from old batteries is not covered by the warranty.
Note: According to international standards, your monitor should be checked for accuracy every year.

Certifications

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

Technical Specifications

• Model: B21H/B21HT
• Wight: 303g(batteries and AC adapter is not included)
• Display: 105x69mm (4.13”x2.72”) LCD Digital Display
• Size: 105 (W) x 129 (L) x 56(H) mm【4.13″（W)x5.08″(L)x2.20″(H)】
• Accessories: 1×Main Device, 1×Cuff, 1×Users manual,
• Operating Conditions: Temperature: 5℃ to 40℃;
• Humidity: 15% to 90% RH;
• Pressure altitude:70KPa~ 106Kpa
• Storage And Shipping Conditions:
• Temperature: -20℃ to 60℃;
• Humidity: 10% to 93% RH; Pressure altitude: 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: 0-295 mmHg
• 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: a) 3 AA batteries, 1.5 V
• b) AC adapter INPUT：100-240VAC 50/60HZ OUTPUT: d.c.5V 1A
• Accessories: Wide range rigid cuff 8.7” – 16.5” (22 – 42 cm) Automatically power off : 60 seconds
• Users: Adult
• IP classification：IP21
• Expected service life of the device and accessories: 5 years Technical alterations reserved!

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.

EMC Declaration

1. This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
2.  Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
3. Caution : This unit has been thoroughly tested and inspected to assure proper performance and operation!
4. Caution : this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used

Guidance and manufacture’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or

the user of device should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
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

| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

|

• ±2 kV for power supply lines
• ±1 kV for input/output lines

|

Not applicable

|

Mains power quality should be that of a typical commercial or hospital environment.

• Surge
• IEC 61000-4-5

|

• ± 1 kV line(s) to line(s)
• ± 2 kV line(s) to earth

| Not applicable| Mains 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

|

• 0 % UT; 0.5 cycle
• at 0°,45°,90°, 135°,
• 180°, 225°, 270°,
• 315°
• 0 % UT ; 1 cycle 70 % UT; 25/30
• cycle
• • 0% UT; 250/300
• cycle

| Not applicable| Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8|

• 30 A/m
• 50/60Hz

|

• 30 A/m
• 50/60Hz

| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test| IEC 60601 test leve| Compliance level| Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6|

• 3 Vrms
• 150 kHz to 80 MHz 3 V RMS outside the
• ISM band, 6 V RMS in the ISM and amateur bands
• 80% AM at 1kHz

| Not applicable|

• Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
• Recommended separation distance
• d=0.35√p d=1.2√p

Radiated RF IEC 61000-4-3|

• 10 V/m
• 80 MHz to 2.7 GHz 80% AM at 1kHz

|

• 10 V/m
• 80 MHz to
• 2.7 GHz 80% AM at 1kHz

|

• 80MHz to 800MHz： d=1.2√p
• 800MHzto 2.7GHz： d=2.3√p
• Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance.

| | |
| | |

• Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.

• Interference may occur in the vicinity of equipment marked with the following symbol:

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

• B   Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Guidance and manufacture’s declaration – electromagnetic emission

The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The device use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11| Class B| The device is suitable for use in all establishments, including domestic establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3| Not applicable

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

• For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.

Guidance and manufacturer’s declaration – electromagnetic immunity|
---|---
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment.|
Test frequency (MHz)| Band a (MHz)| Service a)| Modulationa)| Maximum power (w)| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

|
385| 380-390| TETRA 400| Pulse Modulationb) 18 Hz| 1.8| 0.3| 27|
450| 430-470| GMRS 460,| FM c)| 2| 0.3| 28|
| | FRS 460| ±5 kHz deviation| | | |
| | | 1 kHz sine| | | |
710|

704-787

|

LTE Band 13,

17

| Pulse Modulationb) 217 Hz|

0.2

|

0.3

|

9

|
745|
780|
810| | GSM 800/900,| Pulse| | | |
800-960| TETRA 800, iDEN 820,| Modulationb) 18 Hz| 2| 0.3| 28|
870|
|
930| | CDMA 850, LTE Band 5| | | | |
1720| 1700-1990| GSM 1800; CDMA 1900;,GSM 1900; DECT; LTE Band 1,3| Pulse Modulation) 217 Hz| 2| 0.3| 28|
1845|
1970|
| | 4,25;UMTS| | | | |
2450| 2400-2570| Bluetooth, WLAN 802.11 b/g/n,| Pulse Modulation) 217 Hz| 2| 0.3| 28|
| | RFID 2450,| | | | |
| | LTE Band 7| | | | |
5240| 5100-5800| WLAN 802.11 a/n| Pulse Modulationb) 217 Hz| 0.2| 0.3| 9|
5500|
5785|

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

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• For some services, only the uplink frequencies are included.
• The carrier shall be modulated using a 50% duty cycle square wave signal.
• As an alternative to FM modulation. 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

|

• The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
• Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY
• TEST LEVEL in V/m.

|

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, pursuant to 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 in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarant ee 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 receiver.
  • Connect the equipment into 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.

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