yuwell YE630CR Electronic Blood Pressure Monitor User Manual

User’s Manual

Electronic Blood Pressure Monitor
Model：YE630CR
YY-BPM0032D-01(A/0)
Date of issue：2023.03
Service life:
5 years (6 times for each day)
Please read User’s Manual closely before using this monitor.

Intended purpose：
This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with upper-arm circumference ranging from 22 cm to 36 cm at household or medical center (not suitable for neonate, pregnancy  or pre-eclampsia).

Attention items

Pay attention to the symbols shown here to prevent harm and damages to the user.

1. Symbols and their Descriptions

| Caution| | Follow instructions for use
---|---|---|---
| Manufacturer| | Date of manufacture
| Class II device| | Type BF applied part
IP22| IP classification| | EC-Representative
| Keep upright| | Fragile| | Keep dry
| AC current| | DC current
| Serial number| | Indicates the item is a medical
device
| Indicates a carrier that contains unique device identifier
information
| Recover waste electrical and
electronic equipment| | Batch code
| CE marking and notify body number
| An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR (magnetic
racnnanrol anvirnnmant .

Attention items
Pay attention to the following points when measuring, otherwise it may cause damage or incorrect results.

• Sit still for 5 minutes before measuring to ensure quiet and stable mode.
• Do not take the measurement while standing, walking or having body pressed.
• Do not take the measurement after smoking, drinking or coffee (black tea).
• Do not take the measurement after sport or bath.
• Do not speak or move while measuring.
• Do not move, shake arm or bend fingers while measuring.
• Do not take the measurement at extreme temperature condition or the varied severe environment.
• Do not take the measurement in a moving vehicle.
• Do not measure continuously (2~3 minutes or more should be spared between two measurements)， too frequent measurements can cause injury to the patient due to blood flow interference.
• Do not measure within 1 hour after meal.
• Do not use mobile phone near the device.
• For patient of arrhythmia, measuring results may not be accurate.
• Do not keep the cuff in the aerated state for a long time.
• Note: Do not diagnose with the measurement, please follow doctor’s instruction.
• Statement: If the monitor has not been stored in the required temperature and humidity range, it may not conformance to specification.
• The patient is an intended operator.
• Warning: Do not use the cuff over a wound arm or being on an intravenous drip.
• Warning：The AC adapter cable may cause accidental strangulation in infants.
• Do not interconnect this equipment to other equipment not described in the instructions for use.
• Warning：Do not use the device if the arm where intravascular access or therapy, or an arteriovenous (A-V) shunt is present because of temporary interference with blood flow and could result in injury to the patient. Warning: Do not use the cuff on the arm where the side of a mastectomy or lymph node clearance.
• Warning: Note that It will lose function of other monitor devices simutaneously on the same limb while cuff inflating.
• Warning: Check the operation of the automated sphygmomanometer does not result in prolonged impairment of the circulation of the blood of the patient. For patient of arrhythmia, arterial sclerosis, poor perfusion, diabetes, pergnancy, pre-eclampsia, renal diseases, patient motion, trembling, shivering, measuring results may not be accurate.
• Please report serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State.
• Please pay attention to product storage to prevent damage caused by pets, pests or children.

Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
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.

Product structure and parts

Main part

• The suitable upper-arm circumference of the cuff is 22cm~36cm.
• Tips: Out of the given value can lead to inaccu rate results of measurements.
• Service life: 5 years (6 times for each day) for the monitor，5000 times for cuff.

AC adapter(optional)
Please use only the authorized Yuwell AC Adapter (output DC 5V 1A) to charge, and you can contact the local dealer for consultation about the relevant information.
MFR: WEIHAI HITAI ELECTRONICS Co.,LTD.
EU Model: HT-C38B-0510EW UK Model: HT-C38B-0510UW
US Model: HT-C38B-0510WW

Accessories
User’s manual (with warranty card)
USB cable、AC adapter (optional)

Display icons

•The icon appears when Bluetooth is connected.
| Voice function switch-on icon
•When the voice function is switched on, the icon appears.
| Voice function switch-off icon
•When the voice function is switched off, the icon appears.
| Detection icon for cuff wearing
•When the cuff is wrapped loosely, the icon appears. Please measure again after fasten tightly cuff.
| Detection icon for cuff wearing
•When the cuff is wrapped correctly, the icon appears.
| Indication icon for movement error
•When the wrong movement of body during measurement is detected, the icon appears.
| Deflation icon
•When the monitor is deflating, the icon appears.
| Heartbeat icon
•When the pulse is detected, the icon appears.
| Indication icon for irregular heartbeats
•When the irregular pulse signal is detected during
measurement, the icon appears. .1
| The charging icon
• When charging, the icon appears.
| Battery power icon
• Display battery power

Battery charging

This product is powered by lithium battery.
Please make sure the battery is sufficient when using the product.
Connect the Yuwell AC Adapter for charging.

1. Precautions for lithium battery use
2. During charging, the display shows the charging icon and battery level.
3. Please unplug the power adapter after finishing charging.

Note

• Please use the dedicated Yuwell AC Adapter (output DC 5V 1A) to charge, and you can contact the local dealer for consultation about the relevant information.
• Do not measure blood pressure when charging, so as not to cause abnormal measurement.
• Please charge the device in a position where it is easy to disconnect from supply mains.
• Please charge the device in a position disconnect from supply mains.
• Please charge the device in time when the battery is low and it is recommended to use the device frequently.
• Do not place equipment with lithium battery near the fire sourceDo not remove and replace the battery or squeeze the battery with hard objects.
• Do not measure blood pressure when charging, so as not to cause abnormal measurement. In order to extend the service life of lithium battery, it is recommended to maintain more than half of the power.
• When the equipment is not used for a long time (more than 6 months), it is easy to cause the passivation of the electrode material and lead to the decline of the battery performance. It is recommended to make it frequently.
• Please dispose of waste batteries in accordance wi th local environmental protection regulations.
• Do not replace the battery without authorization. Replacement of the battery by untrained personnel may result in overtemperature, fire, or explosion.

Using method of cuff

Either of the upper-arms can be measured. Do not measure other parts of the body.

1. Wind the cuff around the upper arm. The arrow points to the hand. Keep the lower edge of the cuff at the position above 2-3cm to elbow joint. Make the monitor locat joint
2. Make the monitor located on the inside of the arm. Pull the cuff tight and secure it.

The cuff should be worn comfortably, avoiding too tight or loose.

Correct measuring posture

Note
Any blood pressure measurement is influenced by the posture and physical condition of the person being measured.

Wrong measuring posture

Measure blood pressure

Please pay attention to the following items before measurement:
Sit still for 5 minutes before the measurement.
Measurements shall be taken at the same time every day.
Don’t eat, smoke, drink, take bath or do any high impact sport within half an hour before measuring.
For multiple measurements, the time interval between two adjacent measurements should be at least 2-3 minutes or longer.
Estimate your blood pressure condition according to the BP classification table，and consult with your doctor.

1. Press the【Start/Stop】button
   The display shows deflation icon“ ” after pressing the【Start/Stop】button. Then the deflation icon disappears which means the zero testing is finished and the air pump begins to inflate at the same time.

2. Measuring Process
   The monitor starts measurement automatically during inflating. After finishing measurement, the monitor will daflate the air automatically.

Note

• If unexpected readings are obtained, please measure again or consult your doctor.
• Upper limit pressure of air inflation is 300 mmHg/40.0 kPa.
• Don’t keep the inflated state for a long time to avoid damage.
• If the measurement need to be stopped for uncomfortableness or other reasons, please press the【Start/Stop】button.
• The measurement will stop immediately and air releases fast. Take off the cuff manually if the【Start/Stop】button is not working.
• If the SYS is higher than 139mmHg or DIA higher than 89mmHg means having high blood pressure. Please contact with your doctor for advice.

Detection for cuff wearing

When the cuff is wrapped correctly，the icon“ ” appears. When the cuff is wrapped loosely， the icon“ ”appears. Please press the【Start/Stop】button to stop measuring when the icon“ ” appears，and measure again after wrapping cuff correctly.

Indication for movement error
When the wrong movement of body during measurement is detected，the icon “ ” appears.
Please measure again.

Indication for irregular heartbeats
It means that the measurement result may be inaccurate when the icon“ ”appears. Please measure again. If the icon appears during multiple measurements, please consult your doctor.
About bluetooth transmission
To ensure that the measurement results can be transmitted through Bluetooth, please keep the distance between the device and the mobile phone no more than 10 meters.
If you want your blood pressure measurements to be sent to your phone via Bluetooth, get a phone that supports Android 5.0 and above or IOS 9.0 and above to download Yuwell HealthCare+.

1. Take off the cuff
2. Shut down

Press the【Start/Stop】button to shut down. It will power off automatically in 3 minutes without any operation.

About BP classification
Standards to assess high blood pressure, without regard to age, have been established by the world Health Organization (WHO), as shown below：

Mild
hypertension| 18.7-21.2kPa 140-159mmHf| 12.0-13.2kPa 90-99mmHg| Consult dr.
Medium
, hypertension N.| 21.3-23.9kPa 160-179mmHg| 13.3-14.5kPa 100-109mmHg| Consult dr.
.1

Check memory storage datas

The monitor will store the measurement data automatically (including blood pressure and pulse). The upper limit of records is 50. The 50th data will be replaced by the 49th and the 1st data will be replaced by new data when the memory  capacity is full.

1. Press the【Memory】button for the first time to check the average value of the latest 3 times measurement.
2. Press the 【Memory】 button again to check the 1st group of memory.
3. Hold the 【Memory】 button to check quickly the relevant memory data.
4. Press the【Start/Stop】button to shut off the monitor.

Delete the memory storage datas

1. Hold the both【Start/Stop】button and【Memory】button at the same time, until the display shows as the picture that  means the recorded data is cleared.
2. Then press the 【Start/Stop】 button to turn off the monitor.
   Note: This operation will delete all of the recorded data.

Function setting

1. Time and date setting
   Voice volume setting
   Press the【Start/Stop】button and the【Memory】 button at the same time for more than 3 seconds till the year’s number starts flickering.

2. Press the 【Memory】 button to set year.
   After finishing the year setting, press the 【Start/Stop】 button to switch to the month setting.
   Using the same way to set the month, day, hour, and minute in turn.
   After finishing the time and date setting, press the 【Start/Stop】button to enter the voice volume setting. Press the 【Memory】 button to set voice volume.
   Tips：When the voice function button is switched off, there is without voice broadcast function.

3. Unit setting
   After finishing the voice volume setting, press the 【Start/Stop】 button to enter the unit setting.
   Press the 【Memory】 button to choose unit between mmHg and kPa. Press 【Start/Stop】 button to finish setting.

Tips In the condition of kPa unit, it is without voice prompt.

Problems and solutions

The following table lists possible unusual cases while measuring，possible causes and solutions.

tightly and measure again
Err4| Unbale to measure pressure| Keep arm and body still and measure again
Err5| Pressurizing error| Please fasten cuff tightly and measure again
Err6| Pressurizing error caused by arm or body moving| Keep arm and body still and measure again
Err7| Cuff is too loose or falling off| Please fasten cuff tightly and measure again
Err8| Pressure exceeds the maximum value (300mmHg)| Keep arm and body still and measure again
Low Battery| Battery is running out| Connect the power adapter for charging
others| If the monitor doesn’t work after pressing [Start/Stop] button, Please check whether the battery power is , .„.

Note
If the situations cannot be solved or unexpected problem happens, please consult the local distributor.

Alarm system

When the determined blood pressure is outside the rated range, there is a visual alarm signal on the display screen. Please refer to below table for details.

systolic pressure exceeds 260mmHg.
② When DIA display area shows “ 1Hi  ”, it indicates the  measurement result of diastolic pressure exceeds 210mmHg. When SYS display area shows “ ”,
| ① When SYS display area shows “1Lo  ”, it  indicates the  measurement result of systolic pressure is below 60mmHg.
| ② When DIA display area show “ 1Lo  ”, it indicates the  measurement result of diastolic pressure is below 40mmHg.

When the above alarm indication shows, please measure again or consult the doctor.

Note
If the alarm indication cannot be solved and the user feels uncomfortable, please consult the doctor as soon as possible.
If the alarm indication cannot be solved or need to verify the functionality of the alarm system, please consult the manufacturer.

About blood pressure measurement

Q Why stay comfortable and relaxed before taking the measurement？
A If you force to brace the arm or are in tension, that can cause the rise in blood pressure.
Q Why do we need to make sure if we have taken blood pressure medication before taking the measurement？
A If you have taken antihypertensive drugs, the effect will wear off after a few hours and blood pressure will rise accordingly. Please consult your doctor for details.
Q Why need to make sure if the cuff is worn
A If the cuff is worn too tight or loose, the measurement date may be inaccurate.
Q Why keep the center of cuff and heart at the same level？
A If the part measured is above or below the heart，the measurement date may be inaccurate.

Maintenance

Please observe the following items to protect the device and ensure the accuracy of measurement.

• Please store the monitor and accessories properly after use. Do not place the monitor and accessories in high temperature, moisture, dust, or exposure to sunshine.
• The cuff contains an airbag inside, please care in applications, do not fold, pull or twist it.
• Warning: Do not disassemble or repair the device without authorization or modify the device without authorization. Do not service or maintain while the device is in use. Using soft cloth stained with 75% ethanol to clean the device in the case of many people use it, but do not let the ethanol flow into the monitor and cuff. Using soft dry cloth or soft cloth stained with little water to clean the device in the case of single people use it, but do not let the water flow into the monitor and cuff. Don’t cleaning the device when it is connected to the AC mains supply.
• Manufacture will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist service person to repair those parts of the device that are designated by the manufacture as repairable by service person. Degraded sensors can degrade performance.

Tips：We advice to calibrate the monitor according to local laws and regulations (at least once a year).

Features and technical parameters

1. Features
   Voice function
   Lithium battery powered
   Bluetooth transmission
   50 groups of memory

2. Technical parameters

Power
supply| Battery| 3.7V
AC adapter| input 100-240V, 50/60Hz, 0.35A
output 5V  lA
Battery usage times| The battery can be used about 250 times on a full charge
Dimension| Approx. 125mmx62mmx24mm (without cuff)
Weight| About 257g (without cuff)
IP Classification| IP22
against ingress of water with harmful effects: dripping (15°tilted)
against ingress of solid foreign objects: .?-12.5mm diamater
Suitable upper-arm circumference| 22cm-36cm
Service life| 5 years (6 times for each day) for the monitor

Static mode

This function is mainly for professional personnel to enter the static mode to test the monitor through standard pressure gauge.

Warning
Normal users don’t need to know this function and also do not operate. The company will not take any responsibility for damage caused by this operation.

System restores
Press 【Start/Stop】 button, then the screen will show the deflation icon “ ”, which means the system is in restore testing. Several seconds later, the“ ” icon disappears and the air pump starts inflating at the same time, which indicates the  test ended. Then press the 【Start/Stop】 button to stop inflating and enter the next step.

Note
It must restore the system before entering the static mode, otherwise it may cause inaccurate results.
Entering the static mode
Press 【Memory】 button and hold, meanwhile poke the reset hole and hold on for about 3 seconds then release 【Memory】 button. Then screen will show the pressure value“ ”，time and date, mmHg. Now the system has restored and entered the static mode. Now can take the static test.
After entering the static mode, if the screen still does not show “ ”, please operate again as the system restore. Please contact with the local distributor if it still does not work.
The monitor will automatically power off if there is no operation in 4 minutes.

Method of verifying calibration

• The verification system is determined by applying a “ Y ” adapter to the pressure line and attaching a reference standard.
• Enter into the static mode, read the device and the reference gauge simultaneously, the error of 3mmHg is normal by reducing the pressure from 300mmHg to zero at a rate of 3mmHg/s±1mmHg/s.
• If the error out of 3mmHg, please contact the manufacturer for calibration.

Electromagnetic compatibility information

Essential performance:

1. Limits of the error of the manometer:
   Over the temperature range of 5℃ to 40℃ and the relative humidity range of 15% to 90% (non condensing), the maximum error for the measurement of the CUFF pressure at any point of the NOMINAL measurement range shall be  less than or equal to ±3mmHg (±0.4kPa) of the reading.

2. Reproducibility of the BLOOD PRESSURE DETERMINATION:
   The laboratory reproducibility of the BLOOD PRESSURE DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be less than or equal to 3.0mmHg (0.4 kPa).

Note

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the SPHYGMOMANOMETER, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• This equipment might not offer adequate protection to radio-frequency communication services.
• The user might need to take mitigation measures, such as relocating or re-orienting the equipment. When the instrument is in use, never put it near other instruments or stack it on other instrument. if you have to put it near other instruments or instruments, please inspect and verify if the instrument could run normally.

WARNING: The Operator should not use the system and should inform the customer service, if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES.
WARNING: Use of accessories 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.
List of cables and accessories is as follows:
There is the potentia risk of radio frequency interference between the device and other devices. If there is, please find out the problems and take the following measures:

1. Turn off the device, and turn on again.
2. Change the direction of the device.
3. Keep the product away from the interferential devices.

Table 1 For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture’ s declaration- electromagnetic’ emission

The YE630CR Electronic Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of YE630CR Electronic Blood Pressure Monitor should assure that it is used in such an environment.
Emission test| Compliance
RF emissions CISPR 11| Groupl
RF emissions CISPR 11| Class B
Harmonic emissions I EC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions
QEC 61000-3-3| Complies
../

Table 2 For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture’ s declaration- electromagnetic emission

The YE630CR Electronic Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of YE630CR Electronic Blood Pressure Monitor should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| +8 kV contact  ±15 kV air| ±8 kV contact ±15 kV air
Electrical fasttransient /burst IEC
61000-4-4| ±2 kV
100kHz repetition frequency| ±2 kV
100kHz repetition frequency
Surge IEC
61000-4-5| ±1 kV line(s) to line(s)
±2 kV line(s) to earth| ±1 kV line(s) to line(s)
Voltage dips IEC 61000-4-11| 0% UT; 0.5 cycle
At 02, 452., 902, 1352, 1802, 2252, 2702 and 3152| 0% UT ; 0.5 cycle
At 02, 452, 902, 1352, 1802, 2252, 2702 and 3152
09614;1 cycle and 70%Ur; 25/30 cycles
Single phase: at 02| 0% UT; 1 cycle and 70% UT ; 25/30 cycles
Single phase: at 02
Voltage interruptions IEC 61000-4-11| 0% UT ; 250/300 cycles| 0% UT ; 250/300 cycles
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8| 30A/m
50Hz or 60Hz| 30A/m
50Hz or 60Hz
Proximity magnetic fields IEC 61000-4-39| 8A/m, CW for 30kHz 65A/m, 2,1kHz Pulse modulation for 134,2kHz 7,5A/m, 50kHz Pulse modulation for 13,56MHz| 8A/m, CW for 30kHz. 65A/m, 2,1kHz Pulse modulation for 134,2kHz. 7,5A/m, 50kHz Pulse modulation for 13,56MHz
NOTE: UT is the a.c. mains voltage prior to application of the test level.

Metrax GmbH
Rheinwaldstr. 22, D-78628 Rottweil, Germany
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
NO.1 Baisheng Road Development Zone, Danyang,
Jiangsu 212300 CHINA
www.yuwell.com

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 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.
Radiation Exposure Statement:
This device has been assessed to be in compliance with SAR and/or RF field strength limits. The device can be used in the exposure condition without restriction.
Note: 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 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 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.

References

• 鱼跃集团官方网站

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