Actiiv Blood Pressure Monitor Instructions [ACMMD002]

Actiiv Blood Pressure Monitor User Manual

INTRODUCTION

Safety information

The below signs might appear in the user manual, labeling or other component.
Symbol for “THE OPERATION GUIDE MUST BE READ”
For indoor use only
The Bluetooth Combination Mark
Symbol for “TYPE BF APPLIED PARTS”
 Symbol for “DIRECT CURRENT”
Actiiv Blood Pressure Monitor Instructions [ACMMD002]

CAUTION
Please read this user manual carefully and thoroughly before use.
This device is intended for adult use in the home/domestic environment only.
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 upper 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. Please start or end medical treatment based solely on a physician’s treatment advice.
If you are taking medication, consult your physician to determine the most appropriate time for your measurement. Never change a prescribed medication without your physician’s consent.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
If the pressure of the cuff exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when its pressure exceeds 40 kPa (300 mmHg), detach the cuff from the upper arm and press the homologous button to stop inflation.
Do not use the monitor in strong electromagnetic field conditions (e.g. mobile) that radiate interference signals or electrical fast transient / burst signals.
The device is not AP/APG equipment. It is not suitable for use in the presence of a flammable anesthetic mixture with air (or oxygen, nitrous oxide).
Please keep the unit out of reach of infants or children, since inhalation or swallowing of small parts is dangerous or even fatal.
Please use ACCESSORIES and detachable parts specified / authorised by MANUFACTURER.
Otherwise, it may cause damage to the unit or danger to the user / patient.
The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5: 2009 and ISO 10993-10:2010. It will not cause any potential alergic reaction or contact injury.
Please make sure the unit functions safely and it is in proper working condition before use.

LCD Display Signal

Monitor Components

List

1. Blood Pressure Monitor (ACMMD002)
   

2. Cuff (Type BF applied part) (AC2232-03) (Please use Actiiv authorized cuff.)
   

3. 4*AAA alkaline batteries

4. User manual

BEFORE YOU START

The Choice of Power Supply

1. Battery powered mode: 6VDC 4*AAA alkaline batteries

CAUTION
In order to achieve the best performance and protect your monitor,
please use the authorized / specified battery

Installing and Replacing the Batteries

1. Open the battery door.
2. Insert the batteries according to the polarity indications.
3.  Close the battery door.
   Battery Life: Approx. 44 days
   (Battery capacity: 600 mAH. If measured three times per day, each measurement takes 35s, measuring result display takes 20s and data transmission takes 10s. The current for measurement is 400 mA and that for records display and data transmission is 50 mA and 50 mA separately, while the current when shutdown is 35 uA)

Replace the batteries under following circumstances:
displays on the LCD.
The LCD display dims.
When powering on the monitor, the LCD doesn’t light up.

CAUTION

• 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.
• Dispose old batteries following your local recycling guidelines.

Setting Date, Time and Measurement Unit

Please proceed to time setting before your initial use so as to ensure each record is labeled with a time stamp.

NOTE: The monitor will shut off in 60 seconds after last operation when in Setting Interface.

1. When the monitor is OFF, press and hold “User 1” button to enter Time Setting Mode.
   

2. As pictured on the right, the blinking numeral represents the [HOUR]. Press “Query” button to change the numeral. Each press will increase the numeral by one in a cycling manner.
   
   HOUR

3. Press “User 1” button to confirm the [HOUR]. Then the monitor diverts to [MINUTE] setting.
   
   MINUTE

4. Repeat step 2 and 3 to confirm the [MINUTE]. Then the monitor diverts to [MONTH] and [DAY] setting. MONTH DAY
   
   MONTH                                                DAY

5. Repeat step 2 and 3 to confirm [MONTH] and [DAY]. Then the monitor diverts to [YEAR] setting.
   

6. Repeat step 2 and 3 to confirm [YEAR]. Then the monitor diverts to [UNIT] setting.
   

7. After confirming the measurement unit, the LCD will display “dOnE” and the monitor will shut off.
   

Install App and Pair-Up

With the advanced Bluetooth 4.0 technology applied to this blood pressure monitor, mobile phones which are equipped with Bluetooth functionality are able to receive your personal health data. Just simply install the specially designed app and pair up your blood pressure monitor with your mobile phone by following the instructions below

1.The App is now available in the App Store and Google Play. App name is “LIFESENSE INTERNATIONAL”
You may search for the app, then download and install the app on your iPhone or Android Phone. Simple and convenient!
2.Turn on Bluetooth and the App. Make sure both are ON when pair-up is proceeding.
3.When the monitor is off, press and hold “User 2” button to start pair-up. Symbol and symbol will be shown on the LCD alternatively, indicating pair-up is proceeding.
   
If SUCCESSFUL, symbol will be shown on the LCD.

If FAILED, symbol will shown on the LCD.

Bluetooth Module No.: AW8001
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range : 4 dBm
Supply Voltage: 3-3.6 V

Start Measurement

Apply the Cuff

1. Insert the plug of cuff’s air pipe into the interface located on the right side of the monitor.
   

2. As pictured on the right, wear the cuff on your upper arm.
   

3. Tighten the cuff up. Make sure the cuff is fixed 2 to 3 centimeters above your elbow. You should still be able to insert one finger when the cuff is tightened around your upper arm.
   

4. Correct Posture:
   Take measurement on a bare arm only (no clothing between the arm and monitor). Sit comfortably and relaxed on a chair. The centre of the cuff should remain at the same level as your heart. Your legs should be relaxed with feet falling outwards. Palms up.
   

Start the Measurement

After correctly positioning the cuff, when the monitor is off, press “User 1” (or “User 2”) button to turn on the monitor, and it will complete the measurement process

1.LCD display                                       2.Adjust to zero.
          3.Inflating and measuring.

4.Display and save the results, and the data will be transmitted.

5. Press “User 1” (“User 2”) button to turn off the monitor. Otherwise, the monitor
will shut off within 1 minute after last operation.
Tips:
A. When you have finished taking a measurement, press another user button to begin measuring again.
B. Each user can record a maximum of 60 records.

Data Management

Recall the Records

1. When the monitor is OFF, press “Query” button to retrieve the memory. The monitor will display the average value of last three measurements.
   

2. Press “Query” button again to rotate the records. Up to 60 records will be stored under each user ID. The order of the record, date and time will be displayed alternatively
   

3. Press another user button to switch to display another user’s measurement data.
   

4. When User 2 has no record, the LCD will display just like the picture on the right.
   

5. Press the corresponding User ID button to turn off the monitor. Otherwise, the monitor will shut off within 1 minute after last operation.
   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

1. When under data enquiry mode, press and hold “Query” button for 3 seconds to clear memory. The LCD will display the blinking “dEL ALL”.
   

2. Press “Query” button to confirm deletion from memory. The LCD will display “dEL dOnE” indicates that the deletion is complete, and then turn off.
   

Data Transmission

1. With the device successfully paired-up with your iPhone, the measurement data will be automatically transmitted to your mobile via Bluetooth.
2. The symbol will disappear after successful data transmission, and you may check your personal health data stored in your mobile device.
3. If the data transmission fails, the symbol  will remain. The pending measurement data will be transmitted to your iPhone when next measurement is complete.

CAUTION
Interference may occur in the vicinity of equipment marked with the following symbol and the monitor may interfere with electrical equipment.
To enable the data transmission function, this product should be paired to a Bluetooth end at 2.4 GHz

How to mitigate possible interference?
1. The range between the monitor and the Bluetooth end should be reasonably close, from 1 metre to 10 metres. Please ensure no obstacles between the monitor and the Bluetooth end so as to obtain quality connection.
2. To avoid interference, other electronic devices (particularly those with Bluetooth transmission / Transmitter) should be kept at least 1 metre away from the monitor.

INFORMATION FOR USER

Tips for Measurement

Measurements could be inaccurate if taken in the following circumstances

Maintenance

To obtain the best performance, please follow below instructions.

Cleaning: Before Use: Remove the unit from the storage bag. Use a soft cloth to remove the dirt on the monitor and apply some alcohol to disinfect the cuff before tying the cuff.
After Use: Use a soft cloth to wipe the unit and apply some alcohol to disinfect the cuff before putting the whole unit back in the bag.
Please always disinfect the cuff before applying to another patient.
Disposal: Degraded sensors may result in inaccurate measurement while loosened electrodes may cause the monitor’s failure to power on. The expected life of the monitor is two years. Please dispose of accessories, detachable parts, and the ME equipement according to the local guidelines.

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 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 tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Kindly note that only a physician can tell whether your blood pressure value has reached a dangerous point.

Irregular Heartbeat Detector

This Blood Pressure Monitor is equipped with an intelligent Irregular Heartbeat (IHB) Detector function. During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15, this equipment will light up the IHB symbol on the screen when displaying the measuring 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.

ABOUT BLOOD PRESSURE

Why does my blood pressure vary, even in one day?

1. Individual blood pressure varies every day. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement in the same conditions.
2. Blood pressure variation is greater if the person takes medication.
3. Make sure you wait at least
3 minutes before taking another measurement.

Why is the blood pressure I get from the hospital different from home?

Blood pressure can vary even during a 24 hour period due to influences like the weather, emotions, exercise etc. You may experience different environmental and emotional conditions at a hospital compared to at home which can affect your blood pressure measurements.

Will I get the same result if I measure on the right arm?

It is ok to use the device on both arms, but the results may differ depending on the person. It is recommended that you measure on the same wrist every time to maintain an accurate record of measurements.

Pay attention to the following when measuring 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 or under pressure,
take a few deep breaths before beginning.
If your measurement is inaccurate, wait 4 to 5 minutes before retesting.

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 product is not operating as you think it should, check here before arranging for servicing.

**

SPECIFICATIONS

Power supply: Battery Powered Mode: 6V (4 x AAA-size alkaline-battery)
Display mode: Blue LCD with White Backlight V.A. = 128mm(L) x 50mm(W)
Measurement mode: Oscillographic testing mode
Measurement range: Pressure: 0-40kpa (0~300mmHg) pulse value: (40-199) beats/minute
Accuracy: Pressure: 5℃-40℃ within ±0.4 kPa (3 mm Hg) 0℃-45℃ (out of 5℃-40℃) within ±0.7 kPa (5 mm Hg); Pulse Value: ±5%
Working condition: Temperature:5℃-40℃ Relative Humidity ≤85%RH Atmospheric Pressure: 86-106 kPa
Storage & transportation condition: Temperature:-20℃-60℃ Relative Humidity 10%-93%RH Atmospheric Pressure: 50-106 kPa
Measurement perimeter of the upper arm: About 22cm-32cm
Weight: Approx.300g (Excluding the dry cells)
External dimensions: Approx.18010039mm
Attachment: 4*AAA alkaline batteries,user manual
Mode of operation: Continuous operation
Degree of   protection: Type BF applied part
Device Classification: Battery Powered Mode: Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment
IP Classification: IP22
Software Version: V01
WARNING: No modification of this equipment is allowed.

AUTHORIZED COMPONENT

Contact Information

For more information about our products, please visit For more information about our products, please visit www.actiivfitness.com

Complied European Standards List

Risk Management: EN/ISO 14971:2007
Labeling: EN 1041:2008
User Manual: EN 1041:2008
Generl Requirements for Safety: EN 60601-1:2006/AC:2010 EN 62304:2006/AC:2008 EN 60601-1-6:2010 EN 60601-1-11:2010
Non-invasive Sphygmomanometers General Requirements: EN 1060 1:1995+A2:2009 EN 1060-3:1997+A2:2009 EN 1060-4:2004
Electromagnetic Compatibility: EN 60601-1-2:2007/AC:2010

EMC guidance

**Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC

EMISSIONS – for all ME EQUIPMENT and ME SYSTEMS**

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 2, T he device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
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 – for all ME EQUIPMENT and ME SYSTEMS

**

**Table 4 – Guidance and MANUFACTURER’S declaration – electromagnetic

IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

**

**Table 6 – Recommended separation distances between portable and

mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING**

APPENDIX

Installing App and Pairing

The following steps are for use with iPhone.
The App is also available for Android through Google Play.

1. Search for the App in the App Store.
   The App name is “Lifesense International”. Download and install the App onto your phone.

2. Ensure Bluetooth is turned “ON” on your phone

3. Run the App, the following screen should appear

4. Create a new account or sign in

5. The following screen will appear after you have signed in.
   

6. Press “Edit” at the bottom right corner, untick “Weight”, press the back button and “Yes” to save Data. (this will remove the weight measurement) and return to the Start menu.

7. Press the “Settings” button in the top right corner ( )

8. Press the “Add” button to add a device ( )
   

9. Press the Bluetooth logo
   

10. Please ensure you pressand hold the “Start” button on the blood pressure monitor to initiate Pairing Mode.

11. Once connected, the device will show [ ]. It is now ready to use.

12. Your readings will be recorded on the App, you can find the readings by selecting Blood Pressure in the App as per the image shown here
    

13. The following screen will appear
    

14. To see records, press the “list” button at the top of the screen ( )

15. The following screen will appear
    

16. To delete any unwanted readings, slide to the left on the reading and the delete button will appear

Actiiv Blood Pressure Monitor Instructions [ACMMD002] – Optimized PDF
Actiiv Blood Pressure Monitor Instructions [ACMMD002] – Original PDF

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