microlife TWIN200 VSR Blood Pressure and Cardiovascular Screening Monitor Instruction Manual

microlife TWIN200 VSR Blood Pressure and Cardiovascular Screening Monitor

Indications for Use
The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model BP Office Vascular (TWIN200 VSR) is a non invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm. The device screens for the presence of atrial fibrillation during measurement. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. A recommended test for diagnosing Peripheral Artery Disease (PAD) is performing ankle-arm measurements to assess the ankle brachial index (ABI). The device has proven to be a fast, easy, and reliable alternative for Peripheral Arterial Disease (PAD) screening as has been clinically validated with a Doppler device. The device also provides a user-friendly and more reproducible cuff based brachial-ankle PWV measurement method to evaluate arterial stiffness in clinical practice. The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure
(cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy . The memory data can be transferred to the PC (personal computer) running the Watch  BP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is meant for useing by healthcare professionals in clinical practice.

Contraindications
The device is not intended for measuring blood pressure in patients of age less than 3 years old  infant or neonates. The device measures brachial blood pressure using pressured cuff over upper arm. If the measurementing arm or leg suffers from injuries e.g. open wounds or conditions e.g. intravenous drip or has stents implanted making it unsuitable for surface contact or pressurization of the arm, do not use the device.
The device is not intended to measure pulse rate to check the frequency of pacemaker.
Watch BP product support
https://www.microlife.com/professional-products
Watch BP Software support
https://www.microlife.com/support/software-professional-products
Developers support
https://www.microlife.com/developers

Product description

The WatchBP Office Vascular consists of two major parts

• The device, cuffs and accessories.
• The WatchBP Analyzer Software.

With the WatchBP Analyzer Software

1. The device can be programmed for the blood pressure measurement procedure.
2. Measured blood pressure values can be downloaded to the PC.
3. A PDF report and Microsoft Excel spreadsheet for data analysis can be generated. Download the latest WatchBP Analyzer Software from the Microlife website https://www.microlife.com/support/software-professional-products

Contents

1. WatchBP Office Vascular Monitor
2. Ankle-cuff M size
3. WatchBP Office arm Cuff  Size M (22- 32cm)
4. WatchBP Office arm Cuff  Size L (32- 42cm)
5. Data Cable
6. Mains adapter
7. Instruction manual
8. Quick start guide

Model Type

The device can be upgraded with special features. There are three different types of the device .

• Advanced: WatchBP Ofice Vascular cardiovascular Monitor with AFIB detector and simultaneous double arm measurement.
• ABI: WatchBP Ofice Vascular cardiovascular Monitor with AFIB detector, simultaneous double arm measurement and Ankle brachial measurement.
• PWV: WatchBP Ofice Vascular cardiovascular Monitor with AFIB detector, simultaneous double arm measurement, Ankle-brachial Index (ABI) measurement, brachial-ankle pulse wave velocity baPWV and central blood pressure indices measurement.

Upgrading the device

The ABI, baPWV and central blood pressure indices measurement of the device can be activated through the WatchBP Analyzer. An activation key is needed for activation, the activation key is specific for the device as it matches the ID. Please contact Microlife or the local distributor for additional information.

Product Overview

Display

Initial set up

Attaching the power plug to the power adapter

Select a suitable plug attachment and attach to the power adapter.

Charge the battery completely

When using the device for the first time, charge the battery until the recharge indicator on the device turns green.

Power ON/OFF

Press button to switch on the device. Press and hold button for 3 seconds to switch off the device and turn off the LCD screen. The device displays OFF before turning off.

Set the date, time and the safeguard pressure

Set the year
Press and hold the button for 3 seconds to enter setting mode. The year number flashes in the display. Use the (to go up) or (to go down) button
to select the year. Use the button to confirm your selection and move on to month setting.

Set the month
Use the or button to select the month. Use the button to confirm your selection and move on to day setting.

Set the day
Press the or button to select the day. Use the button to confirm your selection and move on to time setting.

Set the time
Once you have set the hour and minutes and pressed the button, the date and time are set, and the current time is displayed.

Set the Highest inflation pressure (HiP)
Use the or button to select the highest inflation pressure or for AUTO mode. Use the button to to confirm and move on to the Hide function setting.

Set the Hide function
The device features a Hide function to prevent influence of blood pressure in patients due to nervousness triggered by visible blood pressure
measurements. Prese or button to switch ON or OFF the Hide Function. If the Hide function is ON it means that the BP values will not be displayed during the blood pressure measurement. Use the button to confirm and finish the settings. Once you have finished the setting mode the current time is displayed.

The highest inflation pressure can be programmed to the device. The suggested Inflation Pressure is 30 to 40 mmHg above the expected systolic value of the patient. You can select 160, 180, 200, 220 or, 240mmHg or use the default device Displays then the device will automatically inflate the cuff to the optimal cuff pressure. If the selected Highest Inflation Pressure selected is too low to measure a patient’s blood pressure it may result in repumping or an error Err . The date and time on the device automatically synchronizes with the date and time on the computer when connected with the WatchBP Analyzer.

Before using the device

Selecting the correct cuff For upper arm

A variety of different cuff sizes are available. M and L size cuffs are provided with the device. Use the cuff marker to select the cuff size that best matches the circumference of the patient’s upper arm.

M and L size upper arm cuffs are included as standard accessories.

For ankle

M size ankle cuff is included as standard accessories. Contact Microlife or its authorized distributor to purchase cuffs. Use only cuffs provided by Microlife

Fitting the arm cuff properly

Measure the patient’s upper-arm circumference to select the appropriate cuff. Place the cuff over the upper arm so that the air tube and artery mark arrow point towards the lower arm. The artery mark on the cuff must be placed over the brachial artery. Lay the cuff on the arm. Make sure that the lower edge of the cuff lies approximately 2 to 3 cm ( ¾ to 1 inch) above the elbow. Wrap and tighten the cuff around the arm. Leave free space with the size of 2 fingers between the arm of the patient and the cuff. Excessive tightness may cause venous congestion and discoloration of the limb. If the cuff is wrapped too loosely, it cannot be inflated properly, and the measured values may be inaccurate. Remove all clothing covering or constricting the measurement arm. Clothing may interfere with measurement accuracy. Cuffs that do not fit properly may lead to inaccurate readings. Use a different size cuff if the range index at the end of the cuff does not fall into the range specified by the range stripes.

Application of the ankle cuff for measurement in the ankle

The patient must lie down in supine position. Place the ankle cuff on the leg. Make sure the edge of the ankle cuff lies approximately 2 to 3cm ( ¾ to 1 inch above the ankle and notice that the artery mark is on the posterior tibial artery. Wrap and tighten the cuff around the leg. Leave a little free space between the leg of the patient and the cuff. Two fingers should fit between the leg and the cuff.

Taking measurements using the WatchBP Office Vascular

Turn on the power

Turn on the device by pressing the button of the device.

Connect the cuff to the device

Connect the cuffs to the device by inserting the cuff connector into the cuff connector socket.

Select the measurement arm  and ankle

You may select the arms and ankle for the measurement by pressing  MODE the button. Press the MODE button to scroll among the arm  and the ankle (s) for taking the measurement. You may select one arm, both arms for assessing of inter-arm difference or one arm and one leg for ABI/baPWV assessment.

Press the MODE button to switch between each Mode.

Settings of the measurement

The measurement program of the device can be set when the measurement of one arm or both arms is selected, including Number of Measurements, Resting Time Countdown time), Interval Time, AFIB detector, CBP measurement, and Average calculation Discard 1st measurement or not. This can be done as follows

Set the Number of Measurements
Press the button when the device is in AUTO mode to first enter setting of Number of Measurements. Use the button to scroll up and use button to scroll down among one to six measurements. Prese button to confirm the number of measurements and enter Resting Time setting

Set the Resting or countdown Time
Press the button to scroll up and use button to scroll down among 15, 30, 60, 120, 180, 240, 300 seconds of Resting Time. Prese button to confirm and enter Interval Time setting.

Set the Interval Time between measurements
Press the button to scroll up and use button to scroll down among 15, 30, 60, 120, 180, 240, 300 seconds of Interval Time. Prese button to confirm and enter AFIB detector setting.

Set the interval time will be skipped if Number of Measurements is While the number of measurements is set by 6 and CBP option is on, the max
Interval Time is 240.

Set the Atrial fibrillation (AFIB) detector
Press the or button to switch the AFIB detector ON or OFF. Prese button to confirm.  Set the AFIB detector will be skipped if Number of Measurements is

Set the Central blood pressure (CBP) measurement
Press or button to switch ON or OFF CBP measurement. Prese button to confirm. If the device is upgraded with CBP then it is switched on in default.

Average calculation
The device features allow you to discard 1st measurement from averaging while the selected number of measurement is 3, 4, 5, or 6 measurements. Press or button to switch ON or OFF and prese button to confirm the setting of Discarding 1ˢᵗ measurement (d-1) feature and finish the setting. Once you go through the settings, the device returns to standby. The last settings programmed to the device are the default of AUTO mode until you set the program again. Average calculation will be skipped if Number of Measurements is 1 or 2 .

Taking measurement in Single or Both Arm Mode

Press the button to start the measurement when standby when measurement of one arm or both arms is selected. The device shows all the settings and then starts counting down the Resting Time before the first measurement. The average measurement reading is displayed and saved after the measurements are complete. The device switches the display for the average. Systolic Blood Pressure (SYS), Diastolic Blood Pressure, Mean Arterial Pressure (MAP), central Systolic Blood Pressure (cSYS), central Diastolic Blood Pressure, and central Pulse Pressure (cPP) automatically if central blood pressure measurement is enabled. If CBP measurement is enabled, the cuff pressure is held at around 60 mmHg for around 10 seconds to collect sufficient pulse waves. If the difference of blood pressure readings between two arms is more than 15mmHg for Systolic at more than three measurements, the “IAD” icon will show with the result. The “IAD” icon and readings of the higher arm flash. Press button during countdown to skip the countdown. Press button to cancel remaining measurements at anytime during the measurement sequence. Display the results average if available.

Viewing stored values

The device stores blood pressure values of the last measurement(s) procedure in AUTO mode. Press the button to reveal the average of the measurements of AUTO mode. Continue pressing the button to review individual measurements. The device switches the display for values of the individual measurement (including SYS, DIA, MAP, cSYS, cDIA and cPP values) if central blood pressure measurement is enabled. When assessing brachial ankle Pulse Wave Velocity (baPWV) and Ankle Brachial Index (ABI) measurement (one arm and one ankle measurement is selected. Set the Height of User (in cm) – Press the button when one arm and one ankle is selected for measurement to enter setting of Height. Use the button to scroll up and use button to scroll down the Height value. Prese button to confirm and return to standby mode. Height range is within 120-210cm. Only for the device version with baPWV feature.

Taking measurement simultaneously in one Arm & one ankle for ABI or

baPWV assessment

When standby with one Arm & one ankle measurement selected, press the button to start a measurement. The device automated takes two consecutive measurements with 60 seconds resting time and 60 seconds interval time. The device shows the setting of Height and then starts counting down 60 seconds Resting Time before the first measurement. During the measurement, the cuff pressure is held at around 60 mmHg for around 10 seconds to collect sufficient pulse waves. The average measurement reading is displayed and saved after the measurements are complete. The value in left lower corner will switch between ABI/ Pulse Rate and Height/ baPWV.

Using WatchBP Analyzer

The memory data can be transferred to your PC (personal computer) running the WatchBP Analyzer Software by connecting the monitor via USB cable or Bluetooth.

System Requirements for Software

1GHz CPU. 512MB Memory, 4.5GB free hard disk space, Microsoft Windows 7 SP1 / 8 / 10

Installing the Software Program

The latest WatchBP Analyzer Software is available from the Microlife website. https://www.microlife.com/support/software professional products
Double click the download installer and simply follow the instructions provided in the installation window on the computer screen.

Connecting the Device to a Computer

It is important to only use the USB cable provided.

Start the Software Program

Start the software program. The date and time on the device automatically synchronize with the date and time on the computer when successfully connected with WatchBP Analyzer PC software. If the device and WatchBP Analyzer software is connected successfully.

• The is displayed on the LCD screen of the device.
• The device ID, model, version of the Device and batteries condition etc. are displayed on the WatchBP Analyzer software.

Transferring measurement data

Connect the device to the PC. Start the WatchBP Analyzer software program. Click button of the WatchBP Analyzer to transfer the measurement data on the device to a computer.

Deleting measurements

The measurement data on the device will be automatically deleted after clicking in the WatchBP Analyzer software to program a measurement schedule for the next patient. Press and hold button of the device for 7 seconds displays CL, presses button again to clear the memory

Bluetooth connectivity

Pairing the device

Press and hold the button for around 7 seconds, untill the Bluetooth icon flashes and starts pairing mode. The unique 6-digit device ID of the unit is displayed. Connect the device and confirm pairing. The Bluetooth icon is displayed on the LCD screen of the device to show the presence of Bluetooth connection. While Bluetooth connected, allow the use of APP to program the device and/or start measurements. Automated upload data to APP after the finished of measurement. Press and hold the button for 5 seconds displays CL, then press button again to clear the connection.

Rechargeable battery and power adapter

Rechargeable Battery

The device has a built-in, rechargeable Ni-MH battery pack that can perform up to 400 measurement cycles on a full charge. The battery can be recharged with the power adapter provided with the device. The empty battery indicator is displayed when the battery is low.

• When using the device for the irst time, charge the battery until the recharge indicator is off.
• The green recharge indicator indicates that the recharge is in progress.
• When the green recharge indicator is off, it means the recharge is completed.
• When the green recharge indicator lashes, it means that there is a charging error.
• Make sure that the correct Mains Adapter is used. If the condition persists, contact Microlife or the local distributor.

Using a power adapter

Only use the Mains Adapter supplied with the device to recharge the device. If the battery starts losing capacity, contact your local dealer for replacement battery. The battery can be replaced. The External Power icon always shows on LCD display when the adapter is used.

Safety, care, accuracy test and disposal

Safety and protection

This device may only be used for the purposes as described in these instructions. The device comprises of sensitive components and must be treated with caution. The manufacturer cannot be held liable for damage caused by incorrect application. Only activate the pump when the cuff is connected to the device. Do not use the device if you think it is damaged or if anything appears unusual. Observe the storage and operating conditions.

Protect the device from water and moisture.

Protect the device from direct sunlight.

Protect the device from extreme heat and cold.

Avoid proximity to electromagnetic fields, such as those produced by mobile phones.

Never open the device.

Protect the device from impact and drops.

Device cleaning and disinfecting

Use a soft cloth with one of the following recommended cleaning solutions to wipe the exterior of the device. Ethyl or isopropyl alcohol 70% solution

• Hydrogen peroxide 7.5% solution.
• Sodium hypochlorite solution 5.25-6.15%household bleach diluted 1:500 provides >100 ppm available chlorine Then wipe the exterior of the device with a soft, dry cloth.

Cuff cleaning and disinfecting

Remove the bladder. Fold and place the cuff cover inside a washing bag. Wash the cuff cover with warm water 43°C 110°F and a mild detergent in the washing machine.

Pasteurization

Wash the cuff cover in 75°C(167°F) hot water for 30 minutes.

Accuracy test

We recommend the device to be tested for accuracy every 2 years or after mechanical impact (e.g. Being dropped). Please contact Microlife to arrange an accuracy test. Do not iron the cuff.

Disposal
Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, and not as domestic waste. \

Error messages and Troubleshooting

If an error occurs during measurement, the measurement is interrupted and an error message Er is displayed.

the cuff and repeat the measurement.
Er 2| Error signal| During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.
Er 3| No pressure in the cuff| An adequate pressure cannot be generated in the cuff. A leak may have occurred. Replace the blood pressure cuff if necessary. Repeat the measurement.
Er 5| No valid results| The measuring signals are inaccurate, and no result can therefore be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.
Er 11| Signal too weak during central blood pressure measurement| The pulse signals on the cuff are too weak. Re position the cuff and repeat the measurement.
Er 12| Error signal during central blood pressure measurement| During the measurement, error signals were detected by the cuff, caused, for instance, by movement or muscle tension. Repeat the measurement, when keeping the arm still.
Er 13| Cuff pressure errors during central blood pressure measurement| An adequate pressure cannot be generated in the cuff. A leak may have occurred. Check if the cuff is correctly connected and is not too loose. Replace the blood pressure cuff if necessary. Repeat the measurement.
Er 15| Abnormal result of central blood pressure reading| The measuring signals are inaccurate so that no result can be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.

the cuff and repeat the measurement.
Er 2| Error signal| During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.
Er 3| No pressure in the cuff| An adequate pressure cannot be generated in the cuff. A leak may have occurred. Replace the blood pressure cuff if necessary. Repeat the measurement.
Er 5| No valid results| The measuring signals are inaccurate, and no result can therefore be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.
Er 11| Signal too weak during central blood pressure measurement| The pulse signals on the cuff are too weak. Re position the cuff and repeat the measurement.
Er 12| Error signal during central blood pressure measurement| During the measurement, error signals were detected by the cuff, caused, for instance, by movement or muscle tension. Repeat the measurement, when keeping the arm still.
Er 13| Cuff pressure errors during central blood pressure measurement| An adequate pressure cannot be generated in the cuff. A leak may have occurred. Check if the cuff is correctly connected and is not too loose. Replace the blood pressure cuff if necessary. Repeat the measurement.
Er 15| Abnormal result of central blood pressure reading| The measuring signals are inaccurate so that no result can be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.

Troubleshooting

power supply into the wall socket.
Battery is fully discharged| Recharge the rechargeable battery by plugging in the power supply.
Cuff does not inflate properly| Loose connection of the tube| Make sure the tube of the cuff is securely connected to the device.
Leakage of the tube / bladder| Check for cracks on the tube or the bladder. Replace the blood pressure cuff if necessary.

Technical specifications

• Operation temperature/ humidity:  10 to 40 °C (50 to 104 °F)/ 15 – 90 % relative maximum humidity
• Storage temperature/ humidity: -20 to 55 °C (-4 to 131 °F)/ 15 – 90 % relative maximum humidity
• Weight: 620g (including rechargeable battery pack
• Dimensions: 220.4 x 121.7 x 63.3 mm
• Measuring method: Oscillo metric, Systolic blood pressure = K1; Diastolic blood pressure = K5
• Measurement range: 60 – 255mmHg – systolic blood pressure; 30 – 200mmHg – diastolic blood pressure; 30 – 239 beats per minute – pulse
• Cuff pressure display: Range: 0 – 299 mmHg; Resolution: 1 mmHg; Static accuracy :pressure within ± 3 mmHg;
• Pulse accuracy:  ±5 % of the readout value
• Power source: Rechargeable battery pack; 4.8V 2400 mAh; Mains power supply DC 7.5V, 1.5 A
• Expected service life: 2 years
• Reference to Standards: Device corresponds to the requirements of the standard for non- invasive blood pressure
  • IEC 60601-1: 2005+A1:2012
  • IEC 60601-1-2 2014
  • ANSI/AAMI/ISO 81060-2
  • ANSI/AAMI/IEC 80601-2-30
• Electromagnetic Compatibility: Device fulfills the stipulations of the standard IEC 60601-1-2. The stipulations of the EU Directive 93/42/EEC for Medical Devices Class IIa have been fulfilled.
  • Type BF applied part
    Microlife reserves the right to alter technical specifications without prior written notice.

Reference
Kollias, A., et al., Automated determination of the ankle-brachial index using an oscillo metric blood pressure monitor: validation vs. Doppler measurement and cardiovascular risk factor proile. Hypertense Cheng, H.M., et al Measurement accuracy of a stand-alone oscillo metric central blood pressure monitor: a validation report for Microlife WatchBP Ofice Central. Am J Hypertense.

Federal Communications Commission (FCC) Statement
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions this device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation.

• 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.
• This device complies with FCC radiation exposure limits set forth for an uncontrolled environment.
• End users must follow the specific operating instructions for satisfying RF exposure compliance.

Europe / Middle East / Africa
Microlife AG
Espenstrasse 139
9443 Widnau, Switzerland
Tel. +41 71 727 7000
Fax. +41 71 727 7011
Email: watchbp@microlife.ch
www.watchbp.com

Asia
Microlife Corporation
9F., No.431, Ruiguang Rd., Neihu Dist., Taipei City 114, Taiwan (R.O.C.)
Tel. +886 2 8797 1288
Fax +886 2 8797 1283
Email: watchbp@microlife.com.tw
www.watchbp.com

North / Central / South America
Microlife USA, Inc.
1617 Gulf to Bay Blvd
2nd Floor, Suite A
Clearwater, FL 33755, USA
Tel. +1 727 442 5353
Fax +1 727 442 5377
Email: msa@microlifeusa.com
www.watchbp.com

References

• Professional Products - Microlife AG
• Developers - Microlife AG
• Professional Products - Microlife AG
• Professional Software - Microlife AG

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