vivadia Arm Blood Pressure Monito H358 Instruction Manual

vivadia Arm Blood Pressure Monito H358 Instruction Manual

Product Overview

Indications for Use

This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It is intended for home use.

Product Description

**** Product introduction

The Upper Arm Blood Pressure Monitor ZK-B869 can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.

The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD, and arm cuff. The ZK-B869 is powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores some sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.

Package content

Upon opening the product package, you will find the following contents inside:

• Monitor
• Arm cuff
• User manual
• Storage bag

Product main structure

The product is mainly composed of the monitor and arm cuff.

Contraindications

1. Do not use this product on pregnant women, children, or people with no ability to express their own consciousness.
2. Do not use it on patients with cardiac demand pacemaker, defibrillator or implanted metallic or electronic device.
3. Do not use it on patients with severe arrhythmia.

General Warnings and Precautions

Warning! Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

(General usage)

1. This product is only used for daily monitoring of blood pressure and is  not suitable for the diagnosis of hypertension. DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your GP. Only a GP is qualified to diagnose and treat High Blood Pressure.
2. This product is only used for blood pressure measurement. Accidents may occur when used for purposes other than measuring blood pressure.
3. Do not use this device on infants, children or persons who cannot express their intentions.
4. This device is not intended to be a diagnostic device. Always consult your GP.
5. Self-diagnosis of measurement results and self-treatment are dangerous.
6. Do not use the device on an injured arm or if the arm is under undergoing medical treatment.
7. Do not use the device in the presence of flammable anaesthetic gases mixed with air or flammable anaesthetic gases mixed with oxygen or nitrous oxide.
8. Consult your GP before using the device for any of the following  conditions:
9. If you have had a mastectomy.
10. Common arrhythmias such as atrial or ventricular premature beats or  atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases.
11. People with severe blood flow problems or blood disorders as cuff inflation can cause bruising. Acute internal bleeding may be caused by compression of the arm during measurement.
12. Do not take measurements more than necessary. It may cause bruising due to blood flow interference.
13. Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion.
14. Consult your GP before using the device on the arm with an arteriovenous (A-V) shunt. Do not use the device in the area the HF surgical equipment, MRI, or CT scanner exists, or in an oxygen rich environment.
15. Do not use the device with other medical electrical (ME) equipment simultaneously.
16. The air tube or the Micro-USB cable may cause accidental strangulation in children.
17. Contains small parts that may cause a choking hazard if swallowed by children.

Caution! Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.

(General usage)

1. NOTE THAT PATIENT motion, trembling, shivering may affect the measurement reading.
2. Remove the arm cuff if it does not start deflating during the measurement.
3. Do not use the device for any purpose other than measuring blood pressure. Use only the special arm cuff (cuff circumference: 22cm~32cm) provided by the manufacture for this device. Use of other arm cuffs may result in incorrect measurement results.
4. Do not use in a location with moisture, or a location where water may splash on the device.
5. Do not use the device in a moving vehicle (car, airplane).
6. Precision components were used in the construction of this device. Extremes in temperature, humidity, direct sunlight, shock or dust should be avoided.
7. Avoid folding the cuff tightly or storing the tube tightly twisted for long periods, as such treatment may shorten the life of the components.
8. Measurements may be impaired if the device is used close to televisions, microwave ovens, mobile telephones, X-ray or other devices with strong electrical fields.
9. Used equipment, parts and batteries are not treated as ordinary household waste, and must be disposed of according to the applicable regulations.
10. Please keep the pressure of the arm cuff under 295mmHg (39.9kPa).  Inflating to a higher pressure than necessary may result in bruising and numbness where the arm cuff is applied.
11. Changes or modifications not approved by our company will void the user warranty. Do not disassemble or attempt to repair the unit or components by yourself.
12. If the appearance of the cuff is found to be damaged, do not take blood pressure measurements. It may damage your skin.
13. Do not forcibly crease the arm cuff or the air tube excessively.
14. Do not press the air tube while taking a measurement.
15. Do not expose the device to strong shocks or vibrations.
16. Do not inflate the arm cuff when it is not wrapped around your arm.
17. Do not use the device outside the specified environment. It may cause  an inaccurate reading.
18. The accuracy of the product has been tested. It is generally recommended to calibrate the device once every year to ensure that the device is functioning properly and accurately.
19. Do not calibrate the product yourself. If it is necessary to calibrate, please contact a qualified technician.
20. Do not use the device outside the specified environment. It may cause an inaccurate reading.
21. Do not use the device immediately after removing it from an environment below 5 °C. Leave it in at least 1 hour in a warm environment. It may cause an inaccurate reading.
22. Dispose of the device and components according to applicable local regulations. Unlawful disposal may cause environmental pollution.
23. In case of pressure discomfort or pressure not stopping, immediately turn off the unit or pull out the tube plug and quickly exhaust.
24. Avoid eating, drinking tea/caffeine/alcohol, exercising, bathing and smoking for 1 hour before taking a measurement. Rest for at least 10 minutes before taking the measurement. Before performing another blood pressure measurement, please rest quiet for 3 minutes, and the rest time allows the artery to return to the state between blood pressure measurements.
25. Please measure it in the correct position with quiet, stable mood.
26. Please do not speak or move your body during measurement.
27. This product is only applicable to upper arm measurement and is not suitable for measurement of wrist and other parts.
28. This device uses a 63Vdc/1A quick fuse, which will protect the device when the instantaneous current exceeds 1A. At this point the device will not be able to continue working, please contact a qualified technician.

(Adapter with Micro-USB cable (not provided) Usage)

1. Do not use the Micro-USB cable and Adapter if the device or the cable is damaged. Turn off the power and unplug the power plug immediately.
2. Plug the Adapter with Micro-USB cable into the appropriate voltage outlet. Do not use in a multi-outlet plug.
3. Never plug in or unplug the device from the electric outlet with wet hands.
4. Fully insert the power plug into the outlet.
5. When disconnecting the power plug from the outlet, do not pull the power cord. Be sure to pull from the power plug safely.
6. Unplug the adapter when not in use.
7. Disconnect the power plug before cleaning.
8. AC adapter and Micro-USB cable are not provided; the users are required to buy the adapter (DC 5V/500mA) and Micro-USB cable which meet safety requirements of IEC 60601-1 and IEC 60601-1-11. Use of an adapter or Micro-USB cable which does not meet the requirements may damage and/or may be hazardous to the device and users.

(Battery (not provided) Usage)

1. Do not insert the batteries with their polarities incorrectly aligned.
2. Batteries are not supplied; batteries required need to meet safety standards. The ZK-B869 is powered by
3. AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V). Do not use other types of batteries. Do not use new and used batteries together.
4. This device does not support the battery charging function. Do not use  the rechargeable battery to charge in this device.
5. Remove the batteries if the device will not be used for three months or more

Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

• Avoid drinking stimulants such as coffee or alcohol, exercising, bathing and smoking for 1 hour before taking a measurement. Rest for at least 10 minutes before taking the measurement. Before performing another blood pressure measurement, please rest quiet for 3 minutes, and the rest time allows the artery to return to the state between blood pressure measurements.
• Stress raises blood pressure. Avoid taking measurements during stressful times.
• Measurements should be taken in a quiet place.
• Remove tight-fitting clothing from your arm.
• Sit on a chair with your feet flat on the floor. Rest your arm on a table so that the arm cuff is at the same level as your heart.
• Remain still and do not talk during the measurement.
• Keep a record of your blood pressure and pulse readings for your GP.
• Left and right arm can be measured (usually the left arm), left and right arm blood pressure may be different, so the recommended blood pressure values may also be different, it is recommended that you always use the same arm to measure. If the measured values of the two arms vary widely, advise your GP.
• A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency.

Preparation

Display

• F: Blood pressure indicator strip
• G: Low battery symbol
• H: Memory symbol
• I: Date/Time symbol
• J: Systolic blood pressure
• K. Diastolic blood pressure
• L: USER ID symbol
• M: Average value symbol
• N: Voice symbol
• O: Memory number
• P: Heartbeat symbol
• Q: Pulse display
• R: Irregular heartbeat symbol

Display symbols

Irregular heart beat symbol:
When the unit detects an irregular rhythm during the measurement, the Irregular heartbeat symbol will appear on the display with the measurement values. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. If the irregular heartbeat symbol displays with your measurement results, we recommend you consult your GP. Follow the directions of your GP.

Blood pressure level indicator:

The World Health Organization (WHO), the International Society for High Pressure (ISH) developed a blood pressure classification as shown below

Please note that other risk factors (e.g. diabetes, obesity, smoking, etc.) need to be taken into consideration and may affect these figures. Consult with your GP for accurate assessment

Note:

1. The graph is not exact, but may be used as a guide in understanding non invasive blood pressure measurements. The device is only intended for use with adults.
2. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method.

Installing the battery

Remove the battery cover and insert new batteries into the battery compartment as shown, taking care that the polarities + and – are observed.

Note:

Insert the batteries as shown in the picture. If not, the device will not work.

• When LOW BATTERY symbol appears on the display, turn the unit off, and then replace all batteries with new ones at the same time. Do not mix old and new batteries. It may shorten the battery life, or cause the device to malfunction.
• The measurement values continue to be stored in memory even after the batteries are replaced.
• Remove the batteries if the device is not to be used for a long period of time (more than 3 months). Otherwise, the batteries may leak and cause a malfunction.
• Batteries are not provided; The ZK-B869 is powered by 4 AAA dry batteries (DC 6V). Do not use other types of batteries.
• This device does not support the battery charging function. Do not use the rechargeable battery to charge in this device.

Using the Adapter with Micro-USB cable

Insert one end of the Micro-USB cable into the micro-USB port of the device, while insert the other end of the Micro-USB cable into the AC adapter plug for receiving DC 5V.
Plug the Adapter into an electrical outlet. To disconnect the Adapter, unplug the Adapter from the electrical outlet first, and then remove the Adapter with Micro-USB cable form the monitor. Adapter and Micro-USB cable are not provided ; adapter (DC 5V/500mA) and Micro-USB are required

Preventive inspection

1. Check the device before measuring. Check the function of each component, and maintain the good performance of the device.
2. The recommended inspection period is once a month or less.
3. The device should be periodically tested for safety to ensure leakage current insulation, including leakage current.
4. Check if the appearance is intact, whether the cuff is intact, and whether the device can be turned on normally.

User ID, Date & Time, Display Unit, Voice Settings and Memory Clear 

This product provides two display units, mmHg and kPa (Pascal). This manual is illustrated in the unit of mmHg. The factory default setting is mmHg.

Settings

In the shutdown state, press and hold Setting button

indicates the flashing state.

User Switch Setting:

In the shutdown state, press and hold Setting button (about 3 seconds), the User ID symbol  flashes, and then press Memory button to select the User 1 or User 2 .

Date & Time Setting: 

After the User Switch Setting, press Setting button to enter the Date & Time Setting. The Year/Month/Day/Hour/Minute symbol will be flashing, press the Memory button to modify the value. Press the Setting button to save the settings successfully. If the Date & Time is not adjusted, the default is the machine factory time.

Display Unit Setting:

After the Date & Time Setting, press Setting button to enter the Display Unit Setting. The screen will display “PA”, while the lower “OFF” will flash. Press the Memory button to switch between “OFF” and “ON”. Selecting “OFF” means selecting mmHg as the unit, and selecting “ON” means selecting KPA as the unit. Press the Setting button to save the settings successfully.

Voice On/Off Setting:
After the Display Unit Setting, press Setting button to enter the Voice On/Off Setting. The screen will display “SP”, while the lower “ON” will flash, press the Memory button to switch between “ON” and “OFF”. Selecting “ON” means turning on the voice, and selecting “OFF” means turning off the voice. Press the Setting button to save the settings successfully. The factory default setting is Voice ON.

Memory clear

In the shutdown state press and hold the Memory button (about 3 seconds) to turn on, the symbol flashes , and then press the Setting button to delete all the measurement results.

Measurement

Get ready with the arm cuff

Cuff tube connection:

Remove tight-fitting clothing or tight rolled up sleeve from your upper arm. Do not place the arm cuff over thick clothes. Insert the air plug into the air jack firmly.

Attaching the arm cuff:

Take off coat, sweater and other thick clothing, place the cuff directly against the skin, as clothing may cause a faint pulse, and result in a measurement error.
Wrap the arm cuff around your left upper arm, about 2-3cm above the elbow, as shown.
Palms up, the tube straightened and the middle finger in the same extension line, attach the cuff firmly.

Note:

Constriction of the upper arm, caused by rolling up a shirt sleeve, may prevent accurate readings. Do not roll up the sleeves to measure, and the cuffs are in good contact with the arms. Be careful not to rest your arm on the air tube.
Left and right arm can be measured, left and right arm blood pressure may be different, so the recommended blood pressure values may also be different, it is recommended that you always use the same arm to measure. If the measured values of the two arms vary widely, consult your GP

Sit Correctly

Taking a measurement

The monitor can store 2 sets of measurement results (User 1 and User 2), each set can store up to 99 measurement results. This manual to explain the measurements of User 1 as an example, User 2 with reference to the measurement of User 1 operation.

1. Press the Start/Stop button, the device starts, the cuff starts to automatically pressurize (inflating). Pressurize to predetermined value, automatic uniform exhaust, detect the blood pressure and pulse rate.
2. Remove the cuff
3. Press the Start/Stop button to turn off the monitor.
   

Note: Before performing another blood pressure measurement, please rest quiet for 3 minutes, and the rest time allows the artery to return to the state between blood pressure measurements.

Voice broadcast list

The device has voice broadcast function, below is the description of voice broadcast:

Please keep silent and relax. Keep the cuff at bean level.

After the measurement is| Thank yam.
| | completed the measurement result will be broadcast automatically.| Your Blood pressure is : systolic pressure “XXX” millimeter of mercury pillar (or kilopascal); diastolic pressure: “XXX” millimeter of mercury pillar (or blopascal).

Iran pulse is “XXX– beats per minute.

Thank you. Wish you a good health!

2| Memory button| Press the Memory button in the state of shutdown (standby state).| Average Blood Pressure:Systolic pressure: ” XICX ” millimeter of mercury pillar (or lilopascal); diastolic pressure: ” XXX ” millimeter of mercury pillar (or kilopascal).

Your pulse is “XXX” beats per minute.

| | After broadcasting the average blood pressure. press the –Memory-– button or “SET’ button again| Last time your blood pressure was:
Systolic pressure: “300r millimeter of mercury pillar (or kilopascal): diastolic pressure: “XXX” millimeter of mercury; pillar (or kilopascal). Your pulse is: —MOC beats per minute.
3| low battery| When the battery- voltage is lower than 4.4V.| Low battery.

Please replace the battery•.

Note “XXX” in the table indicates the measured blood pressure and pulse value.

Measure results, memory and query

Measurement results:
The measurement results will be displayed on the display screen and voiced. Measurement results automatically saved.
When a measurement error occurs (the blood pressure monitor shows the error E as shown in Picture 2), please wait for 3 minutes after quiet rest. Follow the measurement procedure to re-measure.

Memory:
The unit can store 2 sets of measurement results; each set can store up to 99 group results. When saving the 100 result, the device will delete the oldest measurement result.

Inquire:
After measurement or in the state of shutdown, press the Memory button to view the save

Maintenance and storage

Cleaning and Maintenance

The expected service life of this Upper Arm Blood Pressure Monitor is 5 years. To protect your device from damage, please observe the following:

• Do not place the blood pressure monitor and cuff in a high temperature, moisture, water vapour, or direct sunlight.
• Do not tighten the cuff or air tube tightly or roll the air tube on the monitor.
• Do not disassemble or attempt to repair the device or components. Changes or modification not approved by the manufacturer will void the user warranty. Consult Customer Service.
• Do not let the blood pressure monitor be strongly impacted or shaken (e.g. the blood pressure monitor falls on the ground).
• Do not use any abrasive or volatile cleaners.
• Do not wash the device and any components or immerse them in water.
• Use a soft and dry cloth, or a soft and moistened cloth and neutral soap to clean on the monitor and the arm cuff.
• Do not use gasoline, thinner or similar solvents to clean the cuff.
• Clean the device if necessary. The necessary cleaning of the frequently contacted parts of the device is performed once a week.

Calibration and repair:

1. The accuracy of this device has been rigorously tested and it is generally recommended that the blood pressure monitor be inspected and calibrated at least every year to ensure that the function is normal and accurate. The inspection and calibration should be implemented by a qualified technician.
2. Do not attempt to repair the device or components by yourself. Please consult a qualified technician.

Storage

When not in use, please put it in the storage bag.

1. Unplug the air plug from the air jack
2. Keep the tube gently in the cuff and be careful not to fold the tube
3. Place the unit and cuff in the storage bag, and store them in a clean and safe location
4. Do not place the unit where it is:
   • Easy to splash water
   • High temperature, humidity, direct sunlight, dust or near corrosive gas
   • Easy to tilt, produce vibration and impact.

Error Messages

Installation the Battery.
| Abnormal sensor signal|

1. Do not talk or shake your arms during measurement.

2. Empty the air pressure inside the cuff before measurement.

| No blood pressure values can be measured| Check the attaching position of the arm cuff and measure again according to the Use Manual.
| The measurement result is abnormal.| Check the attaching position of the arm cuff and measure again according to the User Manual.
| No inflation| Check if the cuff is leaking.
Check tithe cuff is too loose.
| Inflating too fast| Check if the air tube is blocked
Check if the cuff is attached too tightly.
| Excessive pressure interference| Measure according to the User Manual. Do not move during the measurement.
| Pressure exceeds limit| Measure according to the User Manual. Do not move during the measurement

External interference is usually caused by a sudden large movement or electromagnetic interference during use, resulting in erroneous measurements.

Troubleshooting

The systolic pressure value is higher or the diastolic pressure value is lower.| The position of the cuff was wrong. The cuff was not properly attached. Attach the arm cuff correctly to the correct position according to the User Manual_

Move or speak while measuring. Do not move or speak during measurement.

The blood pressure value is abnormally high or low.| Whether or not the measurement posture changes each time. Sit correctly according to the User Manual.
Inconsistent with the blood pressure measured by the doctor,

The blood pressure values measured each time are inconsistent.

| Some people will be involuntarily nervous when they see the doctor, which will raise their blood pressure.

Record the trend of changes in daily measurement results and request assistance from doctor

Measure again after rest for 3 minutes.

Press the Start/Stop button. the screen does not display. or the screen suddenly turns off after the screen is displayed.| The batteries are low. You should replace new batteries. Refer to Installation the Battery.
Malfunctions| Do not repair it yourself. Return it to our company for inspection and repair.

Warnings

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 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 should be used no closer than 30cm (12 inches) to any part of the Arm Blood Pressure Monitor, including cables specified by the manufacturer. Otherwise, degradation of this equipment could result.

Symbols

Technical Parameters and Specification

batteries, once a day, no more than 2 minutes each time)
IP classification| 1P22
Operating environment| Temperature: 5*C —40t

Humidity. 15%–80%R.H Air pressure: 70kPa-106klia

Storage and| Temperature: -20V–55t

Model ZK-B869

BATTERIES

• Keep batteries away from children and pets.
• Do not mix used and new batteries.
• Install batteries in accordance with its polarity symbols.
• Remove the batteries if left for long periods.
• Never dispose of batteries in a fire.
• Keep batteries away from children and pets.
• Battery disposal, spent or expired batteries must be properly disposed of and recycled in compliance with local regulations. For detailed information, contact your local authority.
• Follow the battery manufacturer’s safety, usage, and disposal instructions.

DISPOSAL

• Coopers of Stortford use recyclable or recycled packaging where possible.
• Please dispose of all packaging, paper, cartons, packaging in accordance with your local recycling regulations.
• Plastics, polybags – this is made from the following recyclable plastic.
  Code & Symbol|
  ---|---
  Type of Plastic| ABS
  Commonly used for| CD’s, crisp packets, various flexible packaging, baby
  bottles, sunglass lenses
  Notes| Not often or widely recycled
• At the end of the product’s lifespan please check with your local council authorised household waste recycling centre for disposal.

The Enterprise Department
Head Office: 11 Bridge Street Bishop’s Star-Ilford, CM 23 DU
Tel: 0844 462 441X1
Fax: 01279 755 S95
WWW.COOpersofstortford.co.uk

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