Jamr B73T Blood Pressure Monitor

.

Product Information

Specifications

• Model Number: B73T

• Manufacturer: Shenzhen Jamr Technology Co., Ltd.

• Address: 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

• Version Number: 1.0

• Issue Date: 2024-01-12

• Cuff Circumference Range: 22cm to 42cm or 32cm to 52cm

• Intended Users: Adults aged 12 years and above

• Indoor Use Only

• Not suitable for patients under dialysis therapy or on certain
  medications

Product Usage Instructions

1. Introduction and Intended Use

The blood pressure monitor is a fully automatic digital device
designed to measure systolic and diastolic blood pressure, as well
as pulse rate in adults aged 12 years and older. It should be
wrapped around the upper arm with a cuff circumference within the
specified range.

2. Warnings and Precautions

• Only use accessories specified by the manufacturer to avoid
  operational failure.

• Operate and store the device within specified temperature and
  humidity limits.

• Do not use if the unit or power cord is damaged.

• Check the device’s functionality before each use.

• Avoid using in the presence of flammable substances.

• Avoid frequent measurements to prevent blood flow
  interference.

• Avoid placing the cuff over wounds.

3. Important Information on Blood Pressure and its

Measurement

The device provides information on normal blood pressure values
and hypertension levels. Refer to the provided diagram for
guidance.

FAQ

Q: Can the blood pressure monitor be used by individuals under

12 years old?

A: No, the device is intended for use by adults aged 12 years
and above.

Q: Is it safe to use the monitor with other accessories not

specified by the manufacturer?

A: It is not recommended as it may affect the device’s
performance and accuracy.

Q: How often should I change the batteries in the blood

pressure monitor?

A: Regularly check and replace batteries as needed to ensure
proper functioning of the device.

“`

Blood Pressure Monitor
Model Number: B73T 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, 518100 Shenzhen, PEOPLE’S REPUBLIC OF CHINA Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany. Version Number:1.0 Issue Date: 2024-01-12

CONTENTS
1.Introduction and Intended Use……………………………………………………2 2.Important Information on Blood Pressure and its Measurement……5. 3. Components of Your Blood Pressure Monitor……………………………..6 4. Using Your Monitor for the First Time…………………………………………8 5.Measurement Procedure…………………………………………………………….11 6.Care and Maintenance………………………………………………………………..20 7. Warranty/service……………………………………………………………………….21 8. Certifications…………………………………………………………………………….21 9. Technical Specifications……………………………………………………………22 10. EMC Declaration……………………………………………………………………..23
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1.Introduction and Intended Use
The device is a fully automatic digital blood pressure measuring device. It is intended 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 22cm to 42cm or 32cm to 52cm.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 anticoagulant, antiplatelets, or steroids.
Before using, please read this instruction manual carefully and then keep it in a safe place.
1.1 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 privately unless you have the permission of physician. · The device is intended for use by adults only and not intended for use on children and pregnant patient. ·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 in accordance with local regulations after reaching the life cycle. · Any serious incident that has occurred in relation to 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.
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1.2 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: 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 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.
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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.
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2.Important Information on Blood Pressure and its Measurement
2.1. 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).
2.2. Which values are normal?
Please refer to the diagram below(Picture-01)

Diastolic blood pressure (mmHg) 110
100
90
85
80

Severe hypertension Moderate hypertension
Mild hypertension High normal value Normal blood pressure
Optimal blood pressure(target value)

120 130 140 160 180

Systolic blood pressure (mmHg)

Picture-01

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There are six grids in the display of device. Please refer to the picture-01-01. Different grids represent different interval scales of WHO.

Blood pressure value DIA<80 & SYS <120 DIA<85 & SYS <130 DIA<90 & SYS <140 DIA<100 & SYS <160 DIA<110 & SYS <180 DIA>=110 or SYS >=180

WHO Classification Optimal blood pressure Normal blood pressure High normal value Mild hypertension Moderate hypertension Severe hypertension

Picture-01-01

3. Components of your blood pressure monitor

3.1. Measuring unit

Cuff Connector Port

LCD Display

Users Switch button

SET button

Memory button

Picture-02

START/STOP AC Adapter Port button

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1

2 3

4

18

5

6

7

8

9

10

17

11

12 13 14

15

16

Picture-03

3.2 The symbols on the LCD display

1.Date/Time display 3.USER 1 5.Bluetooth symbol 7.Memory symbol 9.Average value symbol 11.Pulse display 13.Irregular heartbeat symbol 14.Movement error symbol 16.Systolic blood pressure 18.Systolic blood pressure Bitmap

2.Low battery symbol 4.USER 2 6.Cuff self-checking function 8.Triple measurement symbol 10.Memory number 12.Heartbeat symbol
(Flashes during measurement)
15.Diastolic blood pressure 17.Diastolic blood pressure Bitmap

3.3 Features of Model B73T
1. Cuff self-checking function 3. Average value function 5. Blood pressure Bitmap 7. External power adapter support 9. Date/time display

2. Double users: 2 x 120 sets memory 4. Irregular heartbeat checking 6. Low battery display 8. Auto power-off 10. Triple measurement

Note: Arm circumference should be measured with a measuring tape in the middle of the relaxed upper arm. Do not force cuff connection into the opening. Make sure the cuff connection is not pushed into the AC adapter port.

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4. Using your Monitor for the First Time
4.1 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 4 “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

Picture-04

Low Battery Indicator 1.When the Low Battery Indicator appears on the display, turn the monitor off and remove all the batteries. Replace with 4 new batteries at the same time. Long-life alkaline batteries are recommended. 2.To prevent the damage of monitor from leaked battery fluid, please take out of battery if the monitor unused in 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.

4.2. System Settings Setting Travel mode:
a) Turn on Travel mode: Original Travel mode is off ,long press ( ) and ( ) for 3s to display LOC on, then the device switches off automatically after 1s,the Travel mode Is set on .When the Travel mode is on ,only long press ( ) and ( ) for 3s is active ,other button is useless.
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b) Turn off Travel mode: Long press ( ) and ( ) for 3s to display the LOC on for 3s, then display LOC off for 3s, The device switches off automatically after 3s, the Travel mode is set off.
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 ( ) button. once the User ID set is OK, press the ( SET) button to save the setting result.
Setting the User ID/Year/Month/Date/ hour system/Time/Volume: After the device is powered off and then reload the battery, the monitor will enter Setting interface. 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 the original year, press the ( ) button continuously and it will reduce continuously 1 by 1, once the year set is OK, press the (SET ) button to confirm
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Setting Month/Date: When the Month display is flashing, press the ( ) button continuously, the month will increase continuously 1 by 1, press the ( ) button continuously and it will reduce continuously 1 by 1, press the (SET) button to confirm, and do in the same way to set the date, press the (SET) button to confirm.
Setting Time: When the hour display is flashing, press the ( ) button continuously, the hour will increase continuously 1 by 1, press the ( ) button continuously and it will reduce continuously 1 by 1, press the (SET) button to confirm, and do in the same way to set the minute, press the (SET) button to confirm.
Setting the buzzer : When display with SP is flashing, press the ( ) or ( ) button to turn on and off the buzzer. press the (SET) button to confirm,then display the (OK) icon and save the setting result.the device switches off automatically after 3s.

5. Measurement Procedure
5.1. 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).
5.2. Fitting the Cuff
Please refer to picture-05 a) 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 on the edge of the cuff (Artery Mark) must lie over the artery which runs down the inner side of the arm. b) To secure the cuff, wrap it around your arm and press the hook and loop closure together. c) 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. d) 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.

4.3. Cuff tube connection Insert the cuff tube into the opening on the left side of the monitor ( As shown in picture-05)
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Picture-05 11

5.3. Measure Procedure 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, 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: 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.
Operate via the App on smart phone with Bluetooth a) Install the App from Google play store or Apple app store. Open Bluetooth on smart phone, and then turn on the App. b) 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. c) 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. 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.
Single measurement operation a) Press the START/STOP button to enter Single measurement operation . The pump begins to inflate the cuff. In the display, the increasing cuff pressure is continually displayed. b) After automatically reaching an individual pressure, the pump stops and the pressure falls. The cuff pressure is displayed during the measurement c) When the device has detected your pulse, the heart symbol in the display begins to blink.
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d) When the measurement has been concluded, the measured systolic and diastolic blood pressure values, as well as the pulse will be displayed. The bitmap shows the last 7 days ago measurements (if there are values). Average of all values on this day. The current measurement is shown with the stars.
e) The measurement results are displayed until you switch the device off. If no button is pressed for 60 seconds, the device switches off automatically. NOTE: you can switch the user ID by pressing the ( ) button before the end of measurement Triple measurement operation : a) Select measurement mode : Long press the START/STOP button for 3s to enter Triple measurement operation . The pump begins to inflate the cuff. In the display, the increasing cuff pressure is continually displayed.
b) After automatically reaching an individual pressure, the pump stops and the pressure falls. The cuff pressure is displayed during the measurement c) When the device has detected your pulse, the heart symbol in the display begins to blink. d) When the first measurement has been concluded, the measured systolic and diastolic blood pressure values, as well as the pulse will be displayed. No historical values are shown in the bitmap, only current value as stars.
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NOTE: you can switch the user ID by pressing the ( ) button end of the first measurement e) Repeat the above steps for the second measurement after 120s,then display the second measurement. Bitmap shows the current value as stars and the first measurement as circles.
f) Repeat the above steps for the third measurement after 120s,then display the third measurement.Bitmap shows the current value as stars and the first and second measurement as circles.
g)After 3s,the average of the last two measurements is displayed. (the first measurement is discarded). The bitmap displays the average as stars and the three measurements as circles.no button is pressed for 10 seconds, the device switches off automatically.
Description of ICONS during measurement : a) Cuff self-checking symbol ( ) The cuff correct symbol() will be displayed if the cuff position is correct, Please check again the cuff if the wrong symbol( ER4 ) is displayed. b) 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.
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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

Please sit vertically and relax your body

Upper arm is not covered or pressed by gusset
Cuff and the heart are at the same level
Relax the hand and palm is upwards

Height difference between the table and the chair 20-30cm

Height to chair 20-35cm

Picture-06

5.4. 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 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.

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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.
5.5. Error Indicates
The following symbol will appear on the display when measuring abnormal

SYMBOL No display appears Er 1
Er 2 Er 3

CAUSE

CORRECTION

Replace both batteries with new ones. Weak battery or improper placement Check the battery installation for proper
placement of the battery polarities.

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.

Monitor could not detect pulse wave Please wear cuff correctly and measure

or cannot calculate the blood

again.If the error is still displayed,please

pressure data

send it to local.

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

The air tube is crimped or the cuff

Er 5

is tied too tigh

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

start the measurement again.If the error is still displayed, please send it to local

distributor

Er 8

The demarcation is incorrect or the device has not been demarcated

Please send back to the local distributor

ER-1

The pulse rate exceeds the upper limit (199 per minute
The pulse rate is less than the lower limit (40 per minute

Beyond the measurement range, normal reminder

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Trouble removal

Problem No power

Check Check the battery power Check the polarity position

Cause and solutions
Replace new one Installation for proper placement of the batteries polarities

No inflation Whether the plug insert Whether the plug broken or leak

Insert into the air socket tightly Change a new cuff

Err and stop working
Cuff leak

Whether move the arm when inflate Check if chatting when measured Whether the cuff wrap too loose Whether the cuff broken

Keep the body peaceful Keep quite when measure Wrap the cuff tightly 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 B73T, or on it’s accessories. Some of the symbols represent standards and compliances associated with the Digital Blood Pressure Monitor B73T and its use.

Authorized Representative in the European Community CE Mark

Manufacturer
Specifies serial number
Type BF applied part
Direct current DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
Follow instructions for use

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The degree of avoid ingress of water or particulate matter into IP21 ME equipment
MR unsafe Medical device Put up Fragile Afraid of the rain Fear of the sun Handle gently Temperature range No Sterilize requirement Not category AP / APG equipment Mode of operation: continuous
5.6. Memory Each unit stores 120 sets measurements for 2 users, totally 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. A.View the memory With the unit off, press the ( ) button to Query memory. (1)If the last measurement was triple measurement and the average of the last two measurements((AVG è) is displayed. (the first measurement is discarded). The bitmap displays the average as stars and the three measurements as circles.
( AVG è memory : the average of triple measurement )
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Otherwise, the average of the last three times (AVG) is displayed (If measurements are less than 3 sets, directly display the first set) The bitmap shows the last 7 weeks ago measurements (if there are values). Average of all values on this week.
(AVG memory mode: the average of the last 3 times measurements )
(single set memory mode) (2)Press the () or () button to query different measurements . B.Delete memory In AVG memory mode 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 or triple measurement average (AVG è) 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. 5.8. Using the AC Adapter You may also operate this monitor using the AC adapter (output 5V DC1A with Type c connector). a) Ensure that the AC adapter and cable are not damaged. b) Plug the adapter cable into the AC adapter port on the right side of the blood pressure monitor.
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c) 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.
6.Care and Maintenance
Wash hands after each time measurement. If one device is used by different patients, wash hands before and after each use. a) Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight. b) The cuff contains a sensitive air-tight bubble. Handle this cuff carefully and avoid all types of stress through twisting or buckling. c) 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, if necessary, 70% isopropanol can be used. The cuff with bladder must not be washed in a dishwasher, clothes washer, or submerged in water. d) Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away from sharp edges. e) Do not drop the monitor or treat it roughly in any way. Avoid strong vibrations. f) Never open the monitor! This invalidates the manufacturer’s warranty. g) Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, not with domestic waste.
6.1. Accuracy test Sensitive measuring devices must be checked for accuracy from time to time. We recommend a periodical inspection of your device by an authorized dealer every 1 year. Please turn to local distributor or the manufacturer.
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7. Warranty/Service
Your blood pressure monitor is guaranteed for 2 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 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.
8. Certifications
Device standard: This device is manufactured to meet the 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 The device was clinicallly investigated and the safety and efficacy is 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.
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9. Technical Specifications
Model: B73T Weight: 303g (batteries and AC adapter is not included) Display: 130×70mm(5.12″×2.76″) LCD Digital Display Size: 138(L)×100 (W)×45.7(H) mm(5.43″×3.94″×1.8″) Packaging list: 1×Main Device, 1×Cuff, 1×Users manual, Operating Conditions: Temperature: 5¥ to 40¥;Humidity: 15% to 90% RH; Storage And Shipping Conditions:Temperature: -20¥~ +60¥; Humidity:10%RH~93%RH; Atmospheric pressure range70kPa~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: a) 4*AA batteries, 6 V
b) AC adapter INPUT100-240V AC 50/60HZ OUTPUT5V DC 1A Accessories: Wide range rigid cuff 8.7″- 16.5″ (22 – 42 cm) and 12.6″- 20.47″ (32-52cm) Users: Adult IP classificationIP21 Expected service life of the device and accessories: 5 years Technical alterations reserved!
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10. 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.

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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 level

Compliance level

Electromagnetic environment – guidance

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.

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

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

Recommended separation distance
d=0.35p
d=1.2p
80MHz to 800MHz d=1.2p 800MHzto 2.7GHz d=2.3p 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.

24

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

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations / flicker emissions IEC 61000-3-3

Not applicable

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.

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.

Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m)

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.7 GHz

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.
25

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)
385

Band a) (MHz)
380-390

Service a) TETRA 400

Modulation a)
Pulse Modulationb) 18 Hz

Maximum power (w)
1.8

Distance (m)

IMMUNITY TEST LEVEL (V/m)

0.3

27

450

430-470

GMRS 460,

FM c)

2

0.3

28

FRS 460

±5 kHz deviation

1 kHz sine

710 745 780 810 870 930
1720 1845 1970

704-787 800-960 1700-1990

LTE Band 13, 17
GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5
GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1,3 4,25;UMTS

Pulse Modulationb) 217 Hz
Pulse Modulationb) 18 Hz
Pulse Modulationb) 217 Hz

0.2

0.3

9

2

0.3

28

2

0.3

28

2450
5240 5500 5785

2400-2570 5100-5800

Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE Band 7
WLAN 802.11 a/n

Pulse Modulationb) 217 Hz
Pulse Modulationb) 217 Hz

2

0.3

28

0.2

0.3

9

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.

a ) For some services, only the uplink frequencies are included. b ) The carrier shall be modulated using a 50% duty cycle square wave signal. c ) 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.
26

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 environm ent. This transmitter must not be co- located or operating in conjunction with any other antenna or transmitter.

References

• circles.no

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