KINETIK WELLBEING WBP1 (01) PDF DOCUMENT

The KINETIK WELLBEING WBP1 Blood Pressure Monitor features blood pressure measurement, pulse rate measurement, and result storage. Its features include:

• 65mm×50mm Digital LCD display

• 90 readings memory

• 3rd Generation Technology: Measuring during inflation

The KINETIK WELLBEING WBP1 is a digital monitor intended for use in measuring blood pressure and heartbeat rate with an arm circumference of 22cm to 42cm (about 8¾”-16½”). It is intended for adult indoor use only.

Yes, there are contraindications for the KINETIK WELLBEING WBP1:

1. The device is not suitable for use on women who may be pregnant or are pregnant.

2. The device is not suitable for use on patients with implanted electrical devices, such as cardiac pacemakers and defibrillators.

The KINETIK WELLBEING WBP1 uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the air pressure. Then it starts inflating the arm cuff. Meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also the pulse rate.

Symbol	Description
Read the instructions (actual symbol colours are white on a blue background).	Symbol for “TYPE BF APPLIED PARTS”
CE0197	This product complies with MDD93/42/EEC requirements.
Symbol for “MANUFACTURER”	Symbol for “ENVIRONMENT PROTECTION – Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”
SN	Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”	EC REP: Symbol for “Authorised Representative in the European Community”
Symbol for “MANUFACTURE DATE” and Made in China	REF: Model Reference
IP21	Classification for water ingress and particulate matter
Caution: These notes must be observed to prevent any damage to the device.

Please observe the following safety information when using the KINETIK WELLBEING WBP1:

• 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 electronical 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 prior to 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 or 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 on the basis of a self-measurement. Never alter the dose of a medicine prescribed by a doctor.

• Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury.

• Do not apply the cuff over a wound; otherwise it can cause further injury.

• Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously.

• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure may lead to an ecchymosis.

• Check that operation of the device does not result in prolonged impairment of patient blood circulation.

• The device cannot be used with HF surgical equipment at the same time.

• Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.

• 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.

• The patient is an intended operator. The patient can measure data and change battery under normal circumstances.

• To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.

• If you experience discomfort during a measurement, such as pain in the arm, press the START/STOP button to release the air immediately from the cuff.

• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. If it does not, detach the cuff and press the START/STOP button.

• Before use, make sure the device functions safely and is in proper working condition. The continuous use of a damaged unit may cause injury, improper results, or serious danger.

• Do not wash the cuff in a washing machine or dishwasher.

• Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts.

• Be careful to strangulation due to cables and hoses, particularly due to excessive length.

SYMBOL	DESCRIPTION	EXPLANATION
SYS	Systolic pressure	High blood pressure
DIA	Diastolic pressure	Low blood pressure
PUL/min	Pulse display	Pulse in beats per minute
mmHg	mmHg	Measurement Unit of the blood pressure (1mmHg=0.133kPa)
Blood pressure level indicator	Blood pressure level indicator	Indicate the blood pressure level
Low battery	Low battery	Batteries are low and need to be replaced
Irregular heartbeat	Irregular heartbeat	Blood pressure monitor is detecting an irregular heartbeat during measurement.
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

The following items are included:

1. Blood Pressure Monitor (WBP1)

2. Cuff (Type BF applied part, 22cm-42cm)

3. 4xAAA batteries

4. User manual

The KINETIK WELLBEING WBP1 is powered by 6VDC 4xAAA batteries.

To install or replace them:

• Open the battery cover on the back of the monitor.

• Install the 4xAAA batteries by matching the correct polarity, as shown inside the compartment.

• Replace the battery cover.

You should replace the batteries whenever the ‘Low battery’ symbol shows, the display is dim, or 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 the batteries in 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 with daily garbage.

• Remove the old batteries from the device following your local recycling guidelines.

It is important to set the clock before use so a time stamp can be assigned to each reading. The setting range for the year is 2017-2057 and the time format is 24H.

1. When the monitor is off, press and hold the “START/STOP” button for 3 seconds to enter the mode for year setting. The year will flash.

2. Press the “M” button to change the [YEAR]. Each press will increase the numeral by one in a cycling manner.

3. Press the “START/STOP” button to confirm the [YEAR]. The monitor will then divert to [MONTH] and [DAY] setting, with the month flashing.

4. Repeat steps 2 and 3 to set the [MONTH] and then the [DAY].

5. Repeat steps 2 and 3 to set the [HOUR] and then the [MINUTE].

6. After the hour and minute are set, the LCD will display “donE” and the monitor will turn off.

1. Remove all jewellery, 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. 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. To locate the main artery, press with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm to find where the pulse feels strongest.

4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. The air tube should be positioned on the inside of your arm, about 2-3cm above the elbow bend.

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.

For a more accurate measurement, especially for patients with Hypertension:

• Rest for 5 minutes before first measuring.

• Wait at least 3 minutes between measurements. This allows your blood circulation to recover.

• Take the measurement in a silent room.

• The patient must relax as much as possible and do not move or talk during the measurement procedure.

• The cuff should maintain at the same level as the right atrium of the heart.

• Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.

• 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.

1. With the cuff fitted correctly and the monitor off, press the “START/STOP” button to turn on the monitor. The device will adjust to zero, then inflate the cuff, perform the measurement, and display the result.

2. After the measurement is complete, the systolic pressure, diastolic pressure, and pulse rate will be displayed and saved automatically.

3. To power off the monitor, press the “START/STOP” button. Otherwise, it will turn off automatically within 1 minute.

1. When the monitor is off, press the “M” button. The display will show the average value of the last three readings. If there are fewer than 3 readings, it will display the latest record instead.

2. Press the “M” button again to cycle through the stored records, from most recent to oldest. The date and time of the record will be shown alternately with the measurement values.

To delete all results:

1. When the monitor is in the memory recall mode (after pressing “M” from the off state), press and hold the “M” button for 3 seconds. The display will flash “dEL ALL”.

2. 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 instead of holding it in step 2.

If there are no records, pressing “M” will show dashes on the display.

Measurements may be inaccurate if taken in the following circumstances:

1. Within 1 hour after drinking or eating.

2. Immediately after tea, coffee or smoking.

3. Within 20 minutes after taking a bath.

4. When talking or moving your fingers.

5. In a very cold environment.

6. When you need the bathroom.

To get the best performance, please follow these instructions:

1. Put it in a dry place and avoid sunlight.

2. Avoid contact with water; clean it with a dry cloth in case.

3. Avoid intense shaking and collisions.

4. Avoid dusty and unstable temperature environments.

5. Use wet cloths to remove dirt.

6. Do not attempt to clean the reusable cuff with water and never immerse the cuff in water.

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.

The blood pressure classification published by the World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows. Only a physician can tell your normal BP range and whether your value has reached a dangerous point.

Level	Optimal	Normal	High-normal	Mild	Moderate	Severe
SYS (mmHg)	<120	120-129	130-139	140-159	160-179	≥180
DIA (mmHg)	<80	80-84	85-89	90-99	100-109	≥110

An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure. During each measurement, the monitor records all the pulse intervals and calculates the average. If there are two or more pulse intervals where the difference between each interval and the average is more than ±25%, or four or more pulse intervals where the difference is more than ±15%, the irregular heartbeat symbol appears on the display with the measurement results.

CAUTION: The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat 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.

1. Individual blood pressure varies multiple times every day. It is also affected by the way you wear your cuff and your measurement position, so please take the measurement under the same conditions.

2. If the person takes medicine, the pressure will vary more.

3. Wait at least 3 minutes for another measurement.

Blood pressure can be different throughout the day due to weather, emotion, exercise, etc. Also, the “white coat” effect, where blood pressure usually increases in clinical settings, can cause a higher reading at the hospital.

It is okay for both arms, but there will be some different results for different people. We suggest you measure the same arm every time for consistency.

This section includes a list of error messages and frequently asked questions for problems you may encounter with your KINETIK WELLBEING WBP1. If the product is not operating as you think it should, 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 show Low battery symbol	Batteries are low.	Replace with new batteries
Error message	E 01 shows	The cuff is too tight or too loose.	Refasten the cuff and then measure again.
	E 02 shows	The monitor detected motion while measuring.	Movement can affect the measurement. Relax for a moment and then measure again.
	E 03 shows	The measurement process does not detect the pulse signal.	Loosen the clothing on the arm and then measure again.
	E 04 shows	The treatment of the measurement failed.	Relax for a moment and then measure again.
	EExx, shows on the display.	A calibration error occurred. (XX can be some digital symbol, such as 01, 02, etc., if this similar situation appears, it is a calibration error.)	Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.
Warning message	“out” shows	Out of measurement range	Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.

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: 5°C – 40°C within±3mmHg(0.4kPa) Pulse value:±5%
Normal working condition	A temperature range of: +5°C to +40°C A relative humidity range of 15% to 90%, non-condensing An atmospheric pressure range of: 700 hPa to 1060 hPa
Storage & transportation condition	Temperature: -20°C to +60°C A relative humidity range of ≤ 93%, non-condensing
Measurement perimeter of the upper arm	22cm-42cm
Weight	Approx. 225g (Excluding the dry cells 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 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.
Device Classification	Battery Powered Mode: Internally Powered ME Equipment
Software Version	A04

WARNING: No modification of this equipment is allowed.

The KINETIK WELLBEING WBP1 is suitable for home healthcare environments.

Warning: Do not use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Warning: Use of accessories, transducers 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.

Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment WBP1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test	Compliance
RF emissions CISPR 11	Group 1
RF emissions CISPR 11	Class B
Harmonic emissions IEC 61000-3-2	Not application
Voltage fluctuations/flicker emissions IEC 61000-3-3	Not application

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 application	Not application
Surge IEC61000-4-5	Not application	Not application
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11	Not application	Not application
Power frequency magnetic field IEC 61000-4-8	30 A/m 50Hz/60Hz	30 A/m 50Hz/60Hz
Conducted RF IEC61000-4-6	Not application	Not application
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