Homewell HWEBPM Essentials Blood Pressure Monitor User Manual

Homewell HWEBPM Essentials Blood Pressure Monitor

Specifications

• Brand: Homewell

• Model: TMB-995

• Product Type: Blood Pressure Monitor

• Measurement Type: Arm Type

• Thank you very much for selecting Homewell Essentials Blood Pressure
  Monitor HWEBPM.

• To use the monitor correctly and safely, please read the manual thoroughly.

• Please keep well this manual to reference it in the future.

REFERENCE

Button instuctions

INTRODUCTION

General Description

• Thank you for selecting Homewell Essentials Blood Pressure Monitor (HWEBPM). The monitor features blood pressure measurement, pulse rate measurement, and the result recording. The design provides you with two years of reliable service.
• Readings taken by the HWEBPM are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.
• This manual contains important safety and care information and provides step-by-step instructions for using the product.
• Read the manual thoroughly before using the product.

Features

• 80*60mm Digital LCD
• Maximum 60 records per user
• Measuring during inflation technology

Indications for Use
The Homewell Essentials Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm(about 8¾- 16½). It is intended for adult indoor use only.

Contraindications

1. The device should not be used by any person who may be suspected of or is pregnant.
2. The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, and defibrillators.

Measurement Principle

• This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff.
• Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to deter- mine the systolic pressure and diastolic pressure as well as pulse rate.

Safety Information

• The signs below might be in the user manual, labeling or other components.
• They are the requirement of standard and use.

CAUTION

• This device is intended for adult use in homes only.
• The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronic devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease, and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor before using the unit if you suffer from illnesses.
• The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.
• The device is not intended for patient transport outside a healthcare facility.
• The device is not intended for public use.
• This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
• Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without asking a physician for treatment advice.
• If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.
• Do not take any therapeutic measures based on a self-measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any questions about your blood pressure.
• When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.
• Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in injury to the PATIENT.
• When using this device, please pay attention to the following situations which may interrupt blood flow and influence blood circulation of the patient, thus causing injury to the patient: connection tubing kinking too frequently and consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.
• Warning: Do not apply the cuff over a wound; otherwise it can cause further injury.
• Do not inflate the cuff on the same limb that other monitoring ME equipment is applied around simultaneously because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm may lead to ecchymosis.
• Please check that the operation of the device does not result in prolonged impairment of patient blood circulation.
• When measuring, please avoid compression or restriction of the connection tubing.
• The device cannot be used with HF surgical equipment at the same time.
• The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013.
• To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
• This device is contraindicated for any female who may be suspected of or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
• Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
• This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anesthetic, swollen, and even purple due to a lack of blood.
• When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust, and direct sunlight. Never place any heavy objects on the storage case.
• This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
• The maximum temperature that the applied part can be achieved is 42.8°C while the environmental temperature is 40°C.
• The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.
• Warning: No servicing/maintenance while the ME equipment is in use.
• The patient is an intended operator.
• The patient can measure, and charge power under normal circumstances and maintain the device and its accessories according to the user manual.
• To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
• The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don’t use this device.
• During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with the requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensation or irritation reaction.
• The adaptor is specified as a part of ME EQUIPMENT.
• If you experience discomfort during measurement, such as pain in the arm or other complaints, press any button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when the pressure reaches 40 kPa (300 mmHg), detach the cuff from the arm and press any button to stop inflation.
• Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or danger.
• Do not wash the cuff in a washing machine or dishwasher!
• The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
• It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
• Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
• Manufacturer will make available on request circuit diagrams, part lists, descriptions, calibration instructions, etc., to assist service personnel in parts repair.
• The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate the operation of ME equipment.
• The operator shall not touch the output of the batteries /adapter and the patient simultaneously.
• Cleaning: A dust environment may affect the performance of the unit. Please use a soft cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile cleaners.
• The device doesn’t need to be calibrated within two years of reliable service.
• If you have any problems with this device, such as setting up, maintaining, or using it, please contact the SERVICE PERSONNEL of Huntkey USA Inc..Don’t open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.
• Please report to Huntkey USA Inc. if any unexpected operations or events occur.
• Keep the unit out of reach of infants, young children, or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.
• Be careful to strangulation due to cables and hoses, particularly due to excessive length.
• At least 30 minutes are required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 minutes are required for ME equipment to cool from the maximum storage temperature between uses until it is ready for the intended use.
• This equipment needs to be installed and put into service according to the information provided in the ACCOMPANYING DOCUMENTS;
• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones, and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
• Please use ACCESSORIES and detachable parts specified/authorized by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
• There are no luer lock connectors used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
• Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD Display Signal

Monitor Components

List

The Choice of Power Supply

1. Battery-powered mode: 6VDC 4*AA batteries
2. AC adaptor powered mode: 6V 1A (Not included)
   (Please use the AC adaptor which is authorized by the manufacturer!)
   The right picture is the hole in for power adaptor

CAUTION: To get the best effect and protect your monitor, please use the right batteries and special power adapter which comply with local safety standards.

Installing and Replacing the Batteries

1. Slide off the battery cover.
2. Install the batteries by matching the correct polarity, as shown.
3. Replace the cover.

Replace the batteries whenever the below happens

• The shows
• The display dims
• The display does not light up

CAUTION

• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose of the batteries in the fire. Batteries may explode or leak.
• Remove batteries if the device is not likely to be used for some time.
• Worn batteries are harmful to the environment. Do not dispose of daily garbage.
• Remove the old batteries from the device following your local recycling guidelines.

Setting Date, Time, and Measurement Unit

It is important to set the clock before using your blood pressure monitor so that a time stamp can be assigned to each record that is stored in the memory. (year: 2019—2059 time:12 H)

1. When the monitor is off, hold pressing the “ SET ” button for 3 seconds to enter the mode for the year setting.
2. Press the “ MEM ” button to change the [YEAR].
3. When you get the right year, press the “ SET ” button to sit down and turn to the next step.
4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].
5. Repeat step 2 and 3 to set the [HOUR] and [MINUTE].
6. Repeat step 2 and 3 to set the [UNIT]
7. After the [UNIT] is set, the LCD will display “Done” then turn off.

BEFORE YOU START

Select the User

1. When the monitor is off , press the “ SET ” button shortly to enter user setting mode.
2. Then press the “ SET ” button again, select the user ID between user 1 and user 2
3. After selecting the suitable user ID, press the “ START/STOP ” button to save the setting you have done then the device will turn off.

MEASUREMENT

Tie the Cuff

1. Remove all jewelry, such as watches and bracelets from your left arm.
   Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm.

2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.

3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of your arm in line with the little finger. Or position the artery mark & over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 1 finger approximately 112 inches above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.

4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.

5. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.

6. Helpful tips for Patients, especially for Patients with Hypertension:

   • Rest for 5 minutes before the first measurement.
   • Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
   • Measure a silent room.
   • The patient must relax as much as possible and not move and talk during the measurement procedure.
   • The cuff should be maintained at the same level as the right atrium of the heart.
   • Please sit comfortably. Do not cross your legs
   • Keep your back against the backrest of the chair.
   • For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

Start the Measurement

1. When the monitor is off, press the “START/STOP” button to turn on the monitor, and it will finish the whole measurement, save, and transmit the measurement data for the desired user. (Take User 1 for example.)
2. Press the “START/STOP” button to power off, otherwise it will turn off within 1 minute. Tips:
3. A. You can press the “START/STOP” button at any time to stop measuring during the process of measurement.
4. B. Maximum 60 records are both for USER 1 and USER 2.
5. C. If the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg; or Pulse: 40-199 pulse/minute), the LCD will display “out”.

DATA MANAGEMENT

1. When the monitor is off, please press the “MEM” button to show the average value of the latest three records.If the records are less than 3 groups, it will display the latest record instead. Displays different colors at different levels when the monitor is under the memory recall mode.
   (Take user 1 for example.)

2. Press the “MEM” or “SET” button to rotate the records.
   The order of the record, date and time will be displayed alternatively .

CAUTION: The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list.

Delete the Records
If you did not get the correct measurement, you can delete all results of the selected user by following the steps below.

1. Hold pressing the “MEM” button for 3 seconds when the monitor is in the memory recall mode. The LCD will display “Use ID + dEL ALL”.
2. Press the “MEM” button to confirm deleting, the LCD will display “Use ID + dEL donE” and the monitor will turn off.
3. Hold pressing the “SET” button for 3 seconds when the monitor is in the memory recall mode (excluding the LCDs AVG). The LCD will blink “Use ID + dEL ONE”.
4. Press the “MEM” button to confirm deleting selected record, the LCD will display “Use ID + dEL donE” and the monitor will turn off.
5. If you don’t want to delete the records, press the “START/STOP” button, it will turn off and quit the deletion. Or when it is in the deleting memory mode, it will turn off and quit the deletion if there is no operation in one minute.
6. If there is no record, the LCD will display as below :

INFORMATION FOR USER

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.

Maintenance

To get the best performance, please follow the instructions below

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure

What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classification published by the American Heart Association (AHA).

CAUTION: Please consult a physician if your measuring result falls outside the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point

Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure. During each measurement, the blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. If there are two or more pulse intervals, the difference between each interval and the average is more than the average value of ±25%, or if there are four or more pulse intervals, the difference between each interval and the average is more than the average value of ±15%, then the irregular heartbeat symbol will appear on the display with the measurement result.

CAUTION: The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually, this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times every day. It is also affected by the way you tie your cuff and your measurement position, so please measure the same conditions.
2. If the person takes medicine, the pressure will vary more.
3. Wait at least 3 minutes for another measurement.

Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings

Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.

What you need to pay attention to when you measure your blood pressure at home:

• If the cuff is tied properly.
• If the cuff is too tight or too loose.
• If the cuff is tied on the upper arm.
• If you feel anxious.
• Taking 2-3 deep breaths before beginning will be better for measuring.
• Advice: Relax yourself for 4-5 minutes until you calm down

TROUBLESHOOTING

This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.

AUTHORIZED COMPONENT

Authorized Component

1. Please use the Homewell Essentials authorized adapter (Not included).

Contact Information

• Please call 1-805-383-0003 Monday through Friday,
• 8:30 AM to 4:30 PM PST.
• 735 West Ventura Blvd., Suite B Camarillo, CA 93010
• Homewell Essentials™ is a trademark of Huntkey USA,Inc.
• Distributed by Huntkey USA, LLC.
• 735 West Ventura Blvd., Suite B
• Camarillo, CA 93010

FCC Statement

This equipment has been tested and found to comply with the limits for a Class B digital device, under Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used by the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and 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

COMPLIED STANDARDS LIST

Risk management| EN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application of risk management to medical devices
---|---

Labeling

| EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.

Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements

User manual| EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
General Requirements for Safety| EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical

electrical equipment – Part 1: General requirements for basic safety and essential performance

EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Electromagnetic compatibility| EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
Performance requirements| EN ISO 81060-1:2012 Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

IEC 80601-2-30:2009+A1:2013 Medical electrical equipment-

Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Clinical investigation

| EN 1060-4:2004 Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

ISO 81060-2:2013 Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type

Usability

| EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical

electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices

Software life-cycle processes| EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical

device software – Software life-cycle processes

Bio-compatibility

| ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process

ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

EMC GUIDANCE

EMC Guidance

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 manufacturer’s declaration – electromagnetic emissions

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.

Emissions test| Compliance| Electromagnetic environment – guidance

RF emissions CISPR 11

|

Group 1

|

The device uses 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 emissions CISPR 11|

Class B

| The device is suitable for use in all 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

|

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3|

Complies

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.

Immunity test

|

IEC 60601 test level

|

Compliance level

| Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

|

±8 kV contact

±15 kV air

|

±8 kV contact

±15 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| power supply lines:

±2 kV

input/output lines:

±1 kV

| power supply lines:

±2 kV

|

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

Surge IEC61000-4-5| line(s) to line(s): ±1 kV line(s) to earth: ±2 kV

100 kHz repetition frequency

| line(s) to line(s): ±1 kV

100 kHz repetition frequency

| Mains power quality should be that of a typical commercial or hospital environment.
 | 0%UT; 0.5 cycle

At 0°, 45°, 90°, 135°,

180°,225°,270° and 315°

0%UT ; 1 cycle and

70%UT ; 25/30 cycles Single phase: at 0° 0% UT ; 300 cycle

| 0% UT ; 0.5 cycle

At 0°, 45°, 90°, 135°,

180°,225°,270° and

315°

0% UT ; 1 cycle and

70% UT ; 25/30 cycles Single phase: at 0° 0% UT ; 300 cycle

| Mains power quality should be
 | that of a typical commercial or
Voltage dips,| hospital environment.
short interruptions|
and voltage|
variations on|
power supply|
input lines|
IEC 61000-4-11|
Power frequency (50Hz/60Hz)

magnetic field IEC 61000-4-8

|

30 A/m

50Hz/60Hz

|

30 A/m

50Hz/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 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.
Immunity test| IEC 60601

Test level

| Compliance level|

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6| 150 kHz to

80 MHz:

3 Vrms

6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz

| 150 kHz to

80 MHz:

3 Vrms

6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz

| 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 appropriate for the frequency of the transmitter.

Recomm e nded separation distances: d=0.35 P ;

d=1.2 P

Radiated RF IEC 61000-4-3| 10V/m, 80% Am

at 1kHz

| 10V/m, 80% Am

at 1kHz

| 80 MH z to 800 MHz: d=1.2 P

800 MHz to 2.7 GHz: d=2.3 P

| where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,ashould be less than the compliance level in each frequency range.b 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 3V/m.

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 (transmittters) 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

d = 3.5 P

| 80 MHz to 800 MHz

d = 1.2 P

| 800 MHz to 2.7 GHz

d = 2.3 P

0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation 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.
Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communica- tions equipment)

| Test Frequency (MHz)| Band a) (MHz)| Service a)| Modulation b)| Modulation b) (W)| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

385| 380-390| TETRA 400| Pulse modulation b) 18Hz| 1.8| 0.3| 27

450

|

430-470

| GMRS 460， FRS 460| FM c) ± 5kHz deviation 1kHz sine|

2

|

0.3

|

28

710| 704-787| LTE Band 13,

17

| Pulse modulation b) 217Hz|

0.2

|

0.3

|

9

745
780
810| 800-960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation b) 18Hz| 2| 0.3| 28
870
930
1720| 1700-

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3,

4,25; UMTS

| Pulse modulation b) 217Hz| 2|

0.3

|

28

1845
1970
2450| 2400-

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modulation b) 217 Hz| 2| 0.3| 28
5240| 5100-

5800

| WLAN 802.11

a/n

| Pulse modulation b) 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.
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:

E=

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.

LIMITED WARRANTY

2 Year Limited Warranty
Homewell Essentials products (“Homewell Essentials”) warrants to you, the original purchaser of this new product, that the product shall be free of defects in the original manufacture of the material or workmanship for a period of two (2) years from the original date of your purchase of the product (“Warranty Period”). This product must be purchased from an authorized dealer and packaged with this warranty statement. This warranty does not cover refurbished products.

What does this Warranty Cover?
During the Warranty Period, if the original manufacture of the material or workmanship of the product is determined to be defective by an authorized dealer, Huntkey USA Inc. will (at its sole option): (1) repair the product with new or rebuilt parts, or (2) replace the product at no charge with new or rebuilt comparable products or parts. Products and parts replaced under this warranty become the property of Huntkey USA Inc. and are not returned to you. If service of products or parts are required after the Warranty Period expires, you must pay all labor and parts charges. This warranty lasts as long as you own your product during the Warranty Period. Warranty coverage terminates if you sell or otherwise transfer the product.

How to Obtain Warranty Service?

• Please call 1-805-383-0003 Monday through Friday, 8:30 AM to 4:30 PM PST. You will be provided with a Return Merchandise Authorization (RMA) number and return instructions.
• Send product to:
• Huntkey USA, Inc.

735 W Ventura Blvd., Suite B
Camarillo, CA 93010
Please include the RMA number prominently displayed on the shipping box and include
your name, phone number, and address with the product inside the box.

Where is the Warranty Valid?
This warranty is valid only to the original purchaser of the product in North America
(United States, Canada, and Mexico).

WHAT DOES THE WARRANTY NOT COVER?
This warranty does not cover:

Cosmetic damage

• Damage due to force majeure, such as lightning strikes, fire, flood, etc..
• Accident
• Misuse
• Abuse
• Negligence
• Commercial use
• Modification of any part of the product
• Damage due to incorrect operation or maintenance
• Connection to an incorrect voltage supply
• Attempted repair by anyone other than a facility authorized by Homewell Essentials to service the product
• Products sold as is or with all faults
• Consumables, such as batteries
• Products where the factory-applied serial numbers have been altered or removed

REPAIR REPLACEMENT AS PROVIDED UNDER THIS WARRANTY IS YOUR EXCLUSIVE REMEDY. HOMEWELL ESSENTIALS SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR THE BREACH OF ANY EXPRESS OR IMPLIED WARRANTY ON THIS PRODUCT, INCLUDING, BUT NOT LIMITED TO LOST DATA, LOSS OF USE OF YOUR PRODUCT, LOST BUSINESS OR LOST PROFITS. HOMEWELL ESSENTIALS PRODUCTS MAKES NO OTHER EXPRESS WARRANTIES WITH RESPECT TO THE PRODUCT, ALL EXPRESS AND IMPLIED WARRANTIES FOR THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE WARRANTY PERIOD SET FORTH ABOVE AND NO WARRANTIES, WHETHER EXPRESS OR IMPLIED, WILL APPLY AFTER THE WARRANTY PERIOD. SOME STATES, PROVINCES AND JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE OR PROVINCE TO PROVINCE

FAQ

• Q: How long does the battery last?
  • A: The battery life of the HWEBPM depends on usage. With regular use, the batteries can last for several months before needing replacement.
• Q: Can I use the HWEBPM without tying the cuff tightly?
  • A: It is important to secure the cuff snugly, but not too tight, to ensure accurate measurements. Avoid tying the cuff too loosely as it may result in inaccurate readings.
• Q: Can I share the HWEBPM with other family members?
  • A: Yes, the HWEBPM allows for multiple user profiles. Each user can set up their own profile and switch between them for personalized measurements and record keeping.
• Q: Can I use the HWEBPM for children?
  • A: The HWEBPM is designed for use by adults. It is not recommended for use with children. Consult a healthcare professional for guidance on blood pressure monitoring for children.
• Q: Can I use the HWEBPM if I have an irregular heartbeat?
  • A: The HWEBPM is not recommended for individuals with severe arrhythmias or irregular heartbeats. Consult a healthcare professional for guidance on blood pressure monitoring if you have an irregular heartbeat.

Contact Homewell Essentials:

• For customer service please call 1-805-383-0003
• Homewell Essentials™ is a trademark of Huntkey USA, Inc.

Distributed by Huntkey USA, LLC.
735 W Ventura Blvd Suite B, Camarillo CA 93010

• Distributed by: Huntkey USA, Inc
• Address: 735 West Ventura Blvd., Suite B Camarillo, CA 93010

Manufactured for & Distributed by: Huntkey USA Inc.
735 West Ventura Blvd., Suite B
Camarillo, CA 93010

Made in China

References

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