Kinetik WBP1 Blood Pressure Monitor Instruction Manual
Introduction
Support
Our manual provides information for setup and use. For questions, consult the Troubleshooting page. For further assistance, contact the Customer Care team. They are available Monday to Friday, 9 am-5 pm (excluding bank holidays). Contact methods:
- Phone: +44 1483 937969
- Live Chat: Visit www.kinetikwellbeing.com and send a message.
- Email: customercare@kinetikwellbeing.com
- Post: Kinetik Medical Devices Limited, Unit 11, Perrywood Business Park, Honeycrock Lane, Salfords, Redhill. RH1 5JQ
General Description
Thank you for choosing the Kinetik arm type blood pressure monitor (WBP1). It measures blood pressure, pulse rate, and stores results. This manual contains safety, care, and step-by-step usage instructions. Read it thoroughly before use.
Features:
- 65mm×50mm Digital LCD display
- 90 readings storage
- 3rd Generation Technology: Measuring during inflation
Indications for Use
The Kinetik Blood Pressure Monitor is intended for measuring blood pressure and heartbeat rate for individuals with an arm circumference of 22cm to 42cm (approximately 8¾" to 16½"). It is designed for adult indoor use only.
Contraindications
- The device is not suitable for use by pregnant women.
- The device is not suitable for patients with implanted electrical devices, such as cardiac pacemakers or defibrillators.
Measurement Principle
This product uses the Oscillometric Measuring method. Before each measurement, it establishes a "zero pressure" equivalent to the ambient air pressure. It then inflates the arm cuff and detects pressure oscillations generated by pulse beats to determine systolic and diastolic pressure, and pulse rate.
Safety Information
The following signs may appear on the manual, labeling, or components and are requirements for standard usage:
- Read Instructions: [Symbol indicating to read instructions, typically white on blue]
- CE0197: Indicates compliance with MDD93/42/EEC requirements.
- [Serial Number] (SN): Symbol for Serial Number.
- [Direct Current] (DC): Symbol for Direct Current.
- [Manufacturer] (MF): Symbol for Manufacturer.
- [Manufacture Date] / Made in China: Symbol for Manufacture Date and origin.
- IP21: Classification for water ingress and particulate matter protection.
- [Type BF Applied Parts]: Symbol for Type BF Applied Parts.
- [Environmental Protection]: Symbol indicating electrical waste should not be disposed of with household waste; please recycle where facilities exist.
- [European Representative] (EC REP): Symbol for Authorised Representative in the European Community.
- [Model Reference] (REF): Symbol for Model Reference.
CAUTION: Observe these notes to prevent device damage.
- This device is intended for adult use in homes only.
- Not suitable for neonatal patients, pregnant women, patients with implanted electrical devices, pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral arterial disease, intravascular therapy, AV shunts, or patients who have undergone mastectomy. Consult a doctor if you have illnesses.
- Not suitable for measuring children's blood pressure; consult a doctor for older children.
- Not intended for patient transport outside a healthcare facility or for public use.
- Intended for non-invasive measuring and monitoring of arterial blood pressure on the arm only.
- Do not confuse self-monitoring with self-diagnosis. Monitor blood pressure, but do not start or end medical treatment without physician advice.
- Consult your physician regarding medication and the appropriate time to measure blood pressure. Never change prescribed medication without consulting your physician.
Additional Safety Precautions
- Do not take therapeutic measures based on self-measurement. Never alter doctor-prescribed medication doses. Consult your doctor for any blood pressure questions.
- Arrhythmias (e.g., atrial/ventricular premature beats, atrial fibrillation) may cause measurement deviations. Consult your physician.
- Do not kink the connection tube during use, as this can cause continuous pressure increase, restrict blood flow, and potentially injure the patient.
- Be aware of situations that may interrupt blood flow or circulation: kinking tubing, frequent consecutive measurements, cuff application on arms with intravascular access/therapy or AV shunts, or inflating the cuff on the side of a mastectomy.
- Warning: Do not apply the cuff over a wound, as it may cause further injury.
- Do not inflate the cuff on the same limb where other monitoring ME equipment is applied simultaneously, as this could cause temporary loss of function of the other equipment.
- In the rare event of a fault causing the cuff to remain fully inflated, open the cuff immediately. Prolonged high pressure (over 300mmHg or constant pressure over 15mmHg for more than 3 minutes) can cause ecchymosis.
- Ensure operation does not result in prolonged impairment of patient blood circulation.
- Avoid compression or restriction of the connection tubing during measurement.
- The device cannot be used with HF surgical equipment simultaneously.
- The ACCOMPANYING DOCUMENT confirms clinical investigation according to ISO 81060-2:2013.
- Contact the manufacturer to verify calibration.
- This device is contraindicated for pregnant females. Effects on the fetus are unknown.
- Frequent or consecutive measurements may cause circulatory disturbances or injuries.
- Not suitable for continuous monitoring during medical emergencies or operations, as it can cause numbness, swelling, or discoloration of the arm.
- Store the device in a dry room, protected from extreme moisture, heat, lint, dust, and direct sunlight. Do not place heavy objects on the storage case.
- Use the device only for its intended purpose. The manufacturer is not liable for damage caused by incorrect application.
- The device contains sensitive components and requires careful handling. Observe storage and operating conditions.
- The equipment is not AP/APG and is not suitable for use with flammable anesthetic mixtures.
- Warning: No servicing or maintenance while the ME equipment is in use.
- The patient is the intended operator. Patients can measure data, change batteries, and maintain the device/accessories as per the manual.
- To avoid measurement errors, avoid strong electromagnetic field radiated interference or electrical fast transient/burst signals.
- The blood pressure monitor and cuff are suitable for use within the patient environment. If allergic to polyester, nylon, or plastic, do not use this device.
- Cuff materials have been tested (ISO 10993-5:2009 and ISO 10993-10:2010) and do not cause sensitization or irritation.
LCD Display Signal
The LCD display shows various indicators:
Symbol | Description | Explanation |
---|---|---|
SYS | Systolic pressure | High blood pressure |
DIA | Diastolic pressure | Low blood pressure |
PULSE /min | Pulse display | Pulse in beats per minute |
mmHg | Blood pressure level indicator | Measurement Unit of the blood pressure (1mmHg=0.133kPa). Indicates the blood pressure level. |
[Low Battery Indicator] | Low battery | Batteries are low and need to be replaced. |
[Irregular Heartbeat Symbol] | Irregular heartbeat | Blood pressure monitor is detecting an irregular heartbeat during measurement. |
DMY / Current Time | Current Time | Year/Month/Day, Hour: Minute |
Heartbeat | Heartbeat | Blood pressure monitor is detecting a heartbeat during measurement. |
AVG | Average value | The average value of blood pressure. |
Before You Start
Monitor Components
The pressure measuring system includes:
- 1. Cuff
- 2. Air pipe
- 3. PCBA
- 4. Pump
- 5. Valve
The device features an LCD Display, Memory Button, and Start/Stop Button. It also has a Battery Compartment.
List of Items
- Blood Pressure Monitor (WBP1)
- Cuff (Type BF applied part) for arm circumference 22cm~42cm. Use Kinetik authorized cuffs.
- 4xAAA batteries
- User manual
Power Supply
The monitor operates on 6VDC using 4xAAA batteries.
CAUTION: Use the correct batteries for optimal performance and to protect the monitor.
Installing and Replacing the Batteries
- Open the battery cover.
- Install batteries, matching the correct polarity as shown.
- Replace the battery cover.
Replace batteries when the following occurs:
- The [Low Battery Indicator] symbol appears.
- The display is dim.
- The display does not light up.
CAUTION:
- Do not mix new and used batteries.
- Do not mix different types of batteries.
- Do not dispose of batteries in fire, as they may explode or leak.
- Remove batteries if the device will not be used for an extended period.
- Used batteries are harmful to the environment; do not dispose of them with daily garbage. Remove old batteries following local recycling guidelines.
Setting Date and Time
Setting the clock is important for time-stamping readings. The year setting range is 2017-2057, and the time format is 24H.
- With the monitor off, press and hold the [START/STOP Button] for 3 seconds to enter year setting mode.
- Press the [M Button] to change the [YEAR]. Each press increments the numeral.
- Press the [START/STOP Button] to confirm the [YEAR]. The monitor then proceeds to [MONTH] and [DAY] setting.
- Repeat steps 2 and 3 to set the [MONTH] and [DAY].
- Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
- After setting the hour and minute, the LCD will display "donE" and the monitor will turn off.
Taking a Measurement
Fitting the Cuff
- Remove all jewelry (watches, bracelets) from your left arm. If advised by your doctor due to poor circulation, use your right arm.
- Roll or push up your sleeve to expose the skin. Ensure the sleeve is not too tight.
- With your palm facing up, tie the cuff on your upper arm. Position the tube off-center towards the inner side of the arm, aligned with the little finger. Alternatively, align the artery mark over the main artery (approximately 2 cm above the bend of your elbow on the inside of your arm, where the pulse is strongest).
- The cuff should be snug but not too tight; you should be able to insert one finger between the cuff and your arm.
- Sit comfortably with your arm resting on a flat surface. Place your elbow on a table so the cuff is level with your heart. Turn your palm upwards. Sit upright in a chair and take 5-6 deep breaths.
Helpful tips for patients, especially those with hypertension:
- Rest for 5 minutes before the first measurement.
- Wait at least 3 minutes between measurements to allow blood circulation to recover.
- Take measurements in a silent room.
- Relax as much as possible; do not move or talk during the measurement.
- Ensure the cuff remains level with the right atrium of the heart.
- Sit comfortably, do not cross your legs, keep feet flat on the ground, and your back against the chair backrest.
- For consistent comparisons, measure under similar conditions (e.g., same time of day, same arm, or as directed by a physician).
Start the Measurement
- When the monitor is off, press the [START/STOP Button] to turn it on. The monitor will then proceed through the measurement.
- The display will first show the zero adjustment.
- The cuff will inflate and measure.
- The measurement result (systolic, diastolic, pulse) will be displayed and saved.
- Press the [START/STOP Button] to power off, or it will turn off automatically within 1 minute.
Data Management
Check the Memory
- When the monitor is off, press the [M Button] to display the average value of the latest three records. If fewer than three records exist, it will display the latest record.
- Press the [M Button] to cycle through the stored records. The date and time of the record will be shown alternately.
Delete the Readings
If you obtained an incorrect measurement, you can delete all results for the selected user:
- While the monitor is in memory recall mode, press and hold the [M Button] for 3 seconds. The display will flash "[Delete All]".
- Press the [START/STOP Button] to confirm deletion. The monitor will turn off.
Note: To exit delete mode without deleting any records, press the [START/STOP Button].
If there are no records, pressing the [M Button] will show a specific display indicating this.
Information for User
Tips for Measurement
Measurements may be inaccurate under the following circumstances:
- Within 1 hour after drinking or eating.
- Immediately after consuming tea, coffee, or smoking.
- Within 20 minutes after taking a bath.
- While talking or moving your fingers.
- In a very cold environment.
- When needing to use the bathroom.
Maintenance
For optimal performance, follow these instructions:
- Store the device in a dry place, away from direct sunlight.
- Avoid contact with water. Clean with a dry cloth if necessary.
- Avoid intense shaking and collisions.
- Avoid dusty environments and unstable temperature conditions.
- Use damp cloths to remove dirt.
- Do not attempt to clean the reusable cuff with water or immerse it in water.
About Blood Pressure
What are systolic and diastolic pressure?
Systolic pressure is the maximum value reached when the ventricles contract and pump blood out of the heart. Diastolic pressure is the minimum value reached when the ventricles relax.
[Simple diagram illustrating blood flow and pressure in an artery during contraction and relaxation.]
What is the standard blood pressure classification?
The blood pressure classification published by the World Health Organization (WHO) and the International Society of Hypertension (ISH) in 1999 is as follows:
CAUTION: Only a physician can determine your normal blood pressure range. Consult a physician if your measurement results fall outside the normal range or if you suspect a dangerous condition.
Level | Systolic blood pressure (mmHg) | Diastolic blood pressure (mmHg) |
---|---|---|
Optimal Blood Pressure | <120 | <80 |
Normal Blood Pressure | 120-129 | 80-84 |
High-normal Blood Pressure | 130-139 | 85-89 |
Grade 1 hypertension (mild) | 140-159 | 90-99 |
Grade 2 hypertension (moderate) | 160-179 | 100-109 |
Grade 3 hypertension (severe) | ≥180 | ≥110 |
Irregular Heartbeat Detector
An irregular heartbeat is detected when the heart rhythm varies during blood pressure measurement. The monitor records pulse intervals and calculates an average. If the difference between intervals and the average exceeds certain thresholds (more than ±25% for two or more intervals, or more than ±15% for four or more intervals), the irregular heartbeat symbol appears on the display.
CAUTION: The appearance of the [Irregular Heartbeat Symbol] indicates an irregular heartbeat was detected. This is usually not a cause for concern, but if the symbol appears frequently, seek medical advice. This device detects pulse irregularities early but does not replace a cardiac examination.
Why does my blood pressure fluctuate throughout the day?
- Individual blood pressure varies daily due to factors like cuff wear and measurement position. Measure under consistent conditions.
- Medication can cause pressure variations.
- Wait at least 3 minutes between measurements.
Why do I get a different blood pressure at home compared to the hospital?
Blood pressure varies throughout the day due to weather, emotion, and exercise. The "white coat" effect, where blood pressure increases in clinical settings, also contributes to differences.
Is the result the same if measuring on the right arm?
Results may differ slightly between arms. It is recommended to measure on the same arm consistently.
What you need to pay attention to when you measure your blood pressure at home:
- Ensure the cuff is tied properly.
- Check if the cuff is too tight or too loose.
- Ensure the cuff is tied on the upper arm.
- Avoid feeling anxious.
- Take 2-3 deep breaths before measuring. Relax for 4-5 minutes until calm.
Troubleshooting
This section addresses common error messages and questions. Check here before arranging for servicing.
Problem / Symptom | Check This | Remedy |
---|---|---|
No power / Display will not light up. | Batteries are exhausted. | Replace with new batteries. |
Batteries are inserted incorrectly. | Insert the batteries correctly. | |
Low batteries / Display is dim or shows [Low Battery Indicator]. | Batteries are low. | Replace with new batteries. |
Error message E 01 | The cuff is too tight or too loose. | Refasten the cuff and measure again. |
Error message E 02 | The monitor detected motion while measuring. | Relax for a moment and measure again. Movement can affect the measurement. |
Error message E 03 | The measurement process does not detect the pulse signal. | Loosen clothing on the arm and measure again. |
Error message E 04 | The treatment of the measurement failed. | Relax for a moment and measure again. |
EExx, shows on the display. | A calibration error occurred. (XX can be a digital symbol, e.g., 01, 02). | Retake the measurement. If the problem persists, contact the retailer or customer service department. Refer to the warranty for contact information and return instructions. |
Warning message "out" shows | Out of measurement range. | Relax for a moment. Refasten the cuff and measure again. If the problem persists, contact your physician. |
Specifications
Parameter | Details |
---|---|
Power supply | Battery powered mode: 6VDC 4xAAA batteries |
Display mode | Digital LCD display V.A.65mm×50mm |
Measurement mode | Oscillographic testing mode |
Measurement range | Rated cuff pressure: 0mmHg~299mmHg. Measurement pressure: SYS: 60mmHg~230mmHg, DIA: 40mmHg~130mmHg. Pulse value: 40-199 beats/minute. |
Accuracy | Pressure: ±3mmHg (0.4kPa) within 5°C - 40°C. Pulse value: ±5%. |
Normal working condition | Temperature: +5°C to +40°C. Relative humidity: 15% to 90% (non-condensing, water vapour partial pressure ≤ 50 hPa). Atmospheric pressure: 700 hPa to 1060 hPa. |
Storage & transportation condition | Temperature: -20°C to +60°C. Relative humidity: ≤ 93% (non-condensing, water vapour pressure ≤ 50hPa). |
Measurement perimeter of the upper arm | 22cm~42cm |
Weight | Approx. 225g (excluding batteries and cuff) |
External dimensions | Approx. 120.2mm×108.2mm×68.5mm |
Attachment | 4xAAA batteries, user manual |
Mode of operation | Continuous operation |
Degree of protection | Type BF applied part |
Protection against ingress of water | IP21 (Protected against solid objects ≥12.5mm and vertically falling water drops). |
Device Classification | Battery Powered Mode: Internally Powered ME Equipment |
Software Version | A04 |
WARNING: No modification of this equipment is allowed.
Manufacturer Information / Return Policy
Manufacturer Information
Manufactured by: Harvard Medical Devices Ltd. HK
Company: Harvard Medical Devices Ltd. HK
Address: 1002, Railway Plaza, TST, HK
Authorized European Representative:
Company: Share Info Consultant Service LLC Repräsentanzbüro
Address: Heerdter Lohweg 83, 40549 Düsseldorf
Return Policy
If the product is faulty, please contact the Retailer or Kinetik directly. This does not affect your statutory rights. The retailer's own return policy may also apply; contact the retailer for details.
Complied Standards List and EMC Guidance
Complied Standards List
Standard Category | Standard Title |
---|---|
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 compatibility - 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 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
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warnings:
- Do not use near active HF surgical equipment or RF shielded rooms for magnetic resonance imaging where EM disturbances are high.
- Avoid using this equipment adjacent to or stacked with other equipment to prevent improper operation. If necessary, observe both to ensure normal operation.
- Using accessories, transducers, or cables other than those specified by the manufacturer may increase electromagnetic emissions or decrease immunity, leading to improper operation.
- Portable RF communications equipment should be kept at least 30 cm (12 inches) away from any part of the WBP1, including specified cables, to prevent performance degradation.
Technical description:
- Provides instructions for maintaining basic safety and essential performance regarding electromagnetic disturbances for the expected service life.
- Guidance and manufacturer's declaration on electromagnetic emissions and immunity.
Table 1: Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test | Compliance |
---|---|
RF emissions CISPR 11 | Group I |
RF emissions CISPR 11 | Class B |
Harmonic emissions IEC 61000-3-2 | Not applicable |
Voltage fluctuations/ flicker emissions IEC 61000-3-3 | Not applicable |
Table 2: Guidance and manufacturer's declaration - electromagnetic Immunity
Immunity Test | IEC 60601-1-2 Test level | Compliance level |
---|---|---|
Electrostatic discharge (ESD) IEC 61000-4-2 | ±8 kV contact, ±2 kV, ±4kV, ±8 kV, ±15 kV air | ±8 kV contact, ±2 kV, ±4kV, ±8 kV, ±15 kV air |
Electrical fast transient/burst IEC 61000-4-4 | Not applicable | Not applicable |
Surge IEC61000-4-5 | Not applicable | Not applicable |
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | Not applicable | Not applicable |
Power frequency magnetic field IEC 61000-4-8 | 30 A/m 50Hz/60Hz | 30 A/m 50Hz/60Hz |
Conducted RF IEC61000-4-6 | Not applicable | Not applicable |
Radiated RF IEC61000-4-3 | 10 V/m, 80 MHz - 2.7 GHz, 80% AM at 1 kHz | 10 V/m, 80 MHz - 2.7 GHz, 80% AM at 1 kHz |
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 3: Guidance and manufacturer's declaration - electromagnetic Immunity
Radiated RF Test (IEC61000-4-3 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment) | Frequency (MHz) | Band (MHz) | Service | Modulation | Modulation (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 | 704-745 | LTE Band 13, 217Hz | Pulse modulation b) | 0.2 | 0.3 | 9 | |
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 217 Hz | 2 | 0.3 | 28 | |
5240 | 5100-5800 | WLAN 802.11 a/n | Pulse modulation 217 Hz | 0.2 | 0.3 | 9 | |
5500 | |||||||
5785 |