Operator`s manual - Williams Medical Supplies

HealthSTATS International Pte Ltd

3 Ang Mo Kio Stree 62

#08-25/26 LINK@AMK

Singapore 569139

Phone: +65 6858 2190

+65 6858 6190

Fax: +65 6858 0148 www.healthstats.com

HealthSTATS Technologies (UK) Limited

93-95 Gloucester Place,

W1U 6JQ London.

Phone: +442074878468

Fax: +442074878469

®

Heal hSTATS

Enhancing life • Be Pro active

Operator’s manual

IMPORTANT:

Please read this operator’s manual carefully before using the BPro®.

Authorized agent:

Radial Pulse Wave Acquisition Device

BPro

®

Radial pulse wave acquisition device

Operator’s manual

IMPORTANT:

Please read this operator’s manual carefully before using the BPro.

HealthSTATS reserves the right to change the information in this manual without notice.

No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of

HealthSTATS International Pte Ltd.

HealthSTATS may have patents or pending patent applications, trademarks, copyrights or other intellectual property rights covering the subject matter in this manual. The furnishing of this manual does not give anyone license to these patents, trademarks, copyrights or other intellectual property rights except specifically provided in any written license agreement with HealthSTATS International Pte Ltd.

HealthSTATS assumes no responsibility or liability whatsoever for any incidental or consequential damages, or loss of anticipated benefits or profits, or loss or impairment of data arising from the use of this product.

A-PULSE CASP®, BPro®, BProSOft® and BProSOftCASP® are either registered trademarks or trademarks of HealthSTATS International in Singapore and other jurisdictions.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or any other licensed healthcare practitioner.

© 2015 HealthSTATS International Pte Ltd, Singapore. All rights reserved.

Document no.: M6000J-EN-05

Released in July 2015

Printed in Singapore ii

Contents

Introduction

Indications for use

Symbols

Precautions for use

Precautions

Points to note

Unpacking your BPro® package

Features and functions of the BPro®

Identifications of parts

Control buttons

Operating modes

Time/date mode

Time and date settings

Time and date setting sequence

ABPM mode

ABPM mode settings

ABPM mode parameters

Audible and visual alerts

Audible alerts

Visual alerts

Starting an ABPM session

Selecting the strap length

Taking calibration readings

Preparing the BPro

®

for calibration

Mounting the BPro

®

on the patient

Calibrating the BPro

®

Verifying the calibration

Recalibrating the BPro

®

Flowchart for starting an ABPM session

Things to note during an ABPM session

Information for the patient

Introduction

What is ambulatory blood pressure monitoring (ABPM)?

Precautions for using the BPro

®

Removing the BPro

®

temporarily

Activity log

Terminating an ABPM session

After an ABPM session

Downloading ABPM data to a computer

Deleting ABPM data iii

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Contents

Maintenance and servicing

Battery replacement

Strap removal

Strap installation

Cleaning the BPro

®

Cleaning agent

Cleaning steps

Illustrations

Cleaning the strap

Servicing

Troubleshooting guide

Safety and accuracy of the BPro®

Electrical safety

Accuracy

Manufacturer’s EMC declaration

Specifications

Option to select other devices

Residual risk evaluation

Replaceable component parts

Glossary

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iv

BPro® operator’s manual

Introduction

The BPro® radial pulse wave acquisition device is based on arterial tonometry at the radial artery of the wrist. It can be used as part of the BPro® ambulatory blood pressure

monitoring (ABPM) system, the A-PULSE CASP® pulse wave analysis system, or the

BProSOftCASP® 24-Hour Ambulatory BP/CASP Monitoring System.

The BPro® ABPM system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP) calibrator and the BProSOft® 24-hour ABPM application

software. The BPro® is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the BPro® before each ABPM session. Once calibrated, the

BPro® is capable of recording up to 96 readings of systolic and diastolic blood pressure and pulse rate over a period of 24 hours. The BProSOft software communicates with the

BPro® to retrieve, analyze, display and print ABPM data.

The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse

wave acquisition device, a BP calibrator and the A-PULSE CASP® pulse wave

application software. The BPro® is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed.

The BProSOftCASP® 24-Hour Ambulatory BP/CASP Monitoring System consists of the BPro® radial pulse wave acquisition device, a BP calibrator and the

BProSOftCASP® 24-Hour Ambulatory BP/CASP application software. The BPro® is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed.

The MC3000™ or MC3100™ oscillometric blood pressure monitor, or an equivalent, may be used as the BP calibrator.

This manual focuses on the BPro® radial pulse wave acquisition device. For information on the use of the BProSOft®, A-PULSE CASP® and BProSOftCASP® 24-Hour

Ambulatory BP/CASP application software, refer to their respective manuals.

Introduction and indications for use

1


Intended Use and Indications for use

The BPro® radial pulse wave acquisition device is intended for use with the BP calibrator and BProSOft® 24-hour ABPM application software to measure systolic pressure, diastolic pressure and pulse rate over a period of 24 hours.

The BPro® radial pulse wave acquisition device is also intended for use with the BP calibrator and A-PULSE CASP® pulse wave application software to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other indices from the radial pulse.

The BPro® radial pulse wave acquisition device is also intended for use with the BP calibrator and BProSOftCASP® 24-Hour Ambulatory BP/CASP application software to manage 24-hour ambulatory blood pressure (BP) and central aortic systolic pressure

(CASP), and to retrieve, analyze, display and print ABPM report.

For both applications, the BPro® is intended for use on patients who are eighteen (18) years or older, have a palpable radial pulse, and do not have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation. The results are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

Introduction and indications for use

2


7

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Symbols

No. Symbol

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4

5

6

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10

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12

13

14

PN

15

SN

Description

This product complies with the European Council Directive

93/42/EEC (Medical Device Directive).

Type BF: Device (applied part) is designed to provide special protection against electrical shock

See accompanying documents or see instructions for use

Caution

Date of manufacture

Manufacturer

Authorized representative in the European Community

Dispose of this product and used batteries in accordance with the national regulations for the disposal of electrical products.

Prohibited action

Important information to note

Use by

Lot number

This product and its package do not contain natural rubber latex.

Part number

Serial number

Symbols

3


Precautions for use

Precautions

DO read this operator’s manual thoroughly before using the BPro. For additional precautions refer to the BP calibrator instruction manual

DO calibrate the BPro before every ABPM session.

DO keep the wrist still for about 12–15 seconds during measurements for optimal results.

DO try to keep a safe distance of 0.5 to 1 meter (1.6 to 3.3 ft) between the BPro and sources of electromagnetic radiation such as microwave oven, television or mobile phones when measuring blood pressure. For more details, refer to the manufacturer’s

EMC declaration in this manual.

DO NOT apply the BPro to injured or irritated skin.

DO NOT subject the BPro to extreme temperatures, humidity or direct sunlight.

DO NOT subject the BPro to strong shocks, such as dropping it on the floor.

DO NOT immerse the BPro in water. The BPro is mildly water-resistant (IPX2). Use a dry cloth to wipe the BPro if it gets wet.

DO NOT immerse the BPro in cleaning solution. Follow the recommended cleaning instructions in this manual.

DO NOT attempt to disassemble, service or repair the BPro. Contact HealthSTATS or an authorized agent if a problem occurs. Follow the recommended instructions for replacement of the fastening strap.

DO NOT use the BPro with defibrillators. Remove the BPro before using a defibrillator.

DO NOT use the BPro in the presence of electrosurgery.

DO NOT use the BPro for monitoring of blood pressure during exercise or any vigorous activity.

DO NOT leave the BPro in the “Std by” mode for an extended period of time so as to reduce battery power consumption. Switch back to the time/date mode when the BPro is not in use.

Points to note

A qualified physician should be consulted for diagnosis and interpretation of the blood pressure patterns and other results obtained with the BPro.

The BPro is suitable for use on adults with wrist circumference

≥ 13 cm. It is not suitable for use on children or patients with wrist circumference < 13 cm.

Blood pressure measurements using the BPro are based on calibration to the patient’s unique pulse waveform. Calibration is required before every ABPM session.

A person’s blood pressure fluctuates over a 24-hour period and the BPro will automatically measure blood pressure at regular preset intervals. Readings are stored in the memory of the BPro and may be later downloaded to a computer using the

BProSOft software.

For patients in shock, noninvasive methods of measuring blood pressure may not be reliable because of peripheral vascular changes. Invasive measurement should be considered for patients with signs of shock or whose blood pressure is unstable.

Precautions for use

4


As with the manual auscultatory method, it is not always possible to obtain accurate noninvasive readings under certain conditions. Factors such as patient movement, incorrect positioning of the cuff relative to the heart level, extreme heart rates and arrhythmias can lead to inaccurate measurements. Vibrations, such as those in a moving vehicle, can also lead to inaccurate measurements.

Excessive motion during a measurement cycle may affect the accuracy of the measurement. Three audible beeps are provided to alert the patient to a new measurement cycle and to remind the patient to keep the wrist still.

An event code will be recorded by the BPro whenever it is unable to provide valid blood pressure readings for a measurement cycle even after repeated attempts. The event code will appear on the ABPM report.

Precautions for use

5


Unpacking your BPro package

Ensure that you have all the necessary items in your BPro package. Refer to the components list provided separately.

Unpacking your BPro package

6


Features and functions of the BPro

Identification of parts

6

1

5

2

3

7

8

4

9 16

15

14

13

12

9

11

10

1 LCD housing

2 Backlit LCD

3 BP button

4 Communications port

5 Control button

¬

/ Std by, ▬ , Mode/Set and

6 Strap diverter

7 Back case cushion

8 Fastening strap

9 C-bracket

10 Strap loop

11 Sensor housing

12 Sensor plunger

13 Sensor positioning marker

14 Sensor case cushion

15 Connecting strap

16 Sensor support strap

Features and functions of the BPro

7


Control buttons

Mode/Set

¬

▬

/Std by

BP

Select operating mode

Enter and exit setting mode

Select and set parameter in setting mode

Turn audible beep alerts ON or OFF (for ABPM session only)

Illuminate backlight for 5 seconds

Increase value

Enter and exit calibration mode (Std by and rEADY)

Select day or seconds for display

Delete log

Decrease value

Display day of week and date (month and day)

Calibrate BPro

Verify calibration and start ABPM session

Terminate ABPM session

button

Mode/Set button

®

BP

BP button

¬

/Std by button

▬ button

Communications port


8


Operating modes

Time/date mode

Set time and date

®

B P

ABPM mode

®

B P

PC Conn mode

®

Automatically take blood pressure measurements at preset intervals over a 24-hour ABPM session

Store date and time stamp for every measurement

Indicate optimum strap tension and pulsations for blood pressure measurement

Calibrate BPro before starting each ABPM session

Enter systolic and diastolic calibration readings

Delete ABPM data

Download data to a computer that has BProSOft blood pressure report management software installed

B P


9


Time/date mode

Time and date settings

This mode allows you to set and display time and date.

1. Press and hold ¬/Std by to set the top row to display either seconds or the day of week.

2. Press ▬ to display the day of week and date (month and day) for 5 seconds.

3. Press and hold Mode/Set to enter the time/date parameter setting mode. The selected parameter will flash.

4. Press Mode/Set to select the parameter to be set. Press ¬/Std by or ▬ to increase or decrease the value respectively.

5. Press and hold Mode/Set to exit the setting mode anytime.

y

Press to turn the audible alerts* ON or OFF. y

Press and hold to illuminate backlight.

® y

Press and hold to enter or exit the setting mode. y

Press to switch between parameters.

BP

*The audible alerts apply to ABPM sessions only.

Time and date setting sequence

y

Press and hold to switch between seconds and day. y

Press or press and hold to increase value.

y

Press to show month and day. y

Press or press and hold to decrease value.

Day

Time

Month

Seconds

Year

Minutes

Hour


10


ABPM mode

ABPM mode settings

This mode allows you to set or change parameter settings before performing an ABPM session.

1. Press the Mode/Set button to select the ABPM mode.

ABPM mode screen without any data y Press to turn the audible alerts ON or OFF. y Press and hold to illuminate backlight.

Mode/Set y

Press and hold to enter or exit the setting mode.

y

Press to switch between parameters.

BP

®

¬

/Std by y Press to change setting or delete log. y

Press or press and hold to increase value. y

Press and hold to enter or exit the calibration and verification mode.

▬ y

Press to change setting. y Press or press and hold to decrease value.

BP

y Press to calibrate, verify and start ABPM session.

y Press to stop ABPM session.

2. Press and hold Mode/Set to enter the parameter setting mode. The parameters to be changed will flash.

3. Press ¬/Std by to adjust the parameter upward, delete ABPM data, and enter the calibration and verification mode.

4. Press ▬ to adjust the parameter downward.

5. Press BP to calibrate, verify and start or stop a 24-h ABPM session.

6. Press to turn the audible alerts ON or OFF or to illuminate the backlight for 5 seconds.


11


ABPM mode parameters

Fixed parameters

Interval

Sampling duration

Sampling rate

The measurement interval is fixed at 15 minutes. This will yield 96 measurements over 24 hours.

The sampling duration of the BPro is fixed at 8 seconds.

BPro will sample 8 seconds worth of data and then select valid waveforms for calculation.

The sampling rate of the BPro is fixed at 60 points per second.

Period

The period for the ABPM session is fixed at 24 hours. The

BPro will automatically terminate the ABPM session after 24 hours.

On-demand parameters

Log Delete

Denoted by Log dEL. After downloading the data, you can delete them from memory and get ready for the next ABPM session. Press ¬/Std by to confirm the deletion and a completion message denoted by dOnE will appear.

Audible alerts

Denoted by a bell icon ( ). When this is ON, the icon will be displayed on the BPro.

Audible and visual alerts

Audible alerts

It is recommended that the audible alerts ( ) be turned ON for all ABPM sessions. When this feature is ON, the audible alerts bell icon will be displayed and the BPro will provide the following audible alerts during an ABPM session:

Measurement begins

Measurement repeats

Measurement complete

3 short beeps during ABPM session just before the BPro takes a blood pressure measurement.

1 long beep during ABPM session when the BPro needs to re-take a blood pressure measurement. May occur up to two times.

1 short beep during ABPM session to indicate that the measurement is complete.

The user has the option to turn the audible alerts ON or OFF at anytime in any mode.


12


Visual alerts

The BPro provides a visual alert when the battery is low on power.

Low battery When the low-battery symbol is displayed and flashing, the battery should be replaced. Refer to the section “Battery replacement” for more information on how to replace a battery.


13


Starting an ABPM session

Selecting the strap length

1. Before using the BPro, measure the patient’s wrist circumference using a tailor’s measuring tape.

2. Select the strap length according to the table below:

Wrist circumference

13.0 – 15.0 cm

15.0 – 17.0 cm

17.0 – 21.0 cm

> 21.0 cm

Strap length

95 mm (3.7 in.), small

125 mm (4.9 in.), medium

155 mm ( 6.1 in.), large

185 mm (7.3 in.), extra large

A strap that is too short or too long may not adequately secure the BPro to the wrist.

3. Verify that the strap size is appropriate for the patient before using the BPro.

Taking calibration readings

Step 1

Relax for at least 10 minutes and take 5 or more slow, deep breaths.

Step 2

Take 4 measurements using the BP calibrator with the cuff wrapped around the arm on which the BPro is mounted. Record the systolic, diastolic and pulse rate readings.

Note: Ensure that the correct size is used. Allow an interval of 30 to 60 seconds between measurements. Refer to the instruction manual for the BP calibrator for details.

Step 3

Discard the first set of readings. If any two of the remaining 3 readings for systolic or diastolic pressure differ by more than 10 mmHg, take more measurements until the last

3 consecutive readings for each pressure do not differ from each other by more than 10 mmHg. Then average the 3 readings for each pressure.

Note: The average systolic and diastolic readings will be used for calibration.

Step 4

Remove the cuff from the patient and turn off the BP calibrator.

Starting an ABPM session

14


Preparing the BPro for calibration

Step 5

Ensure that the time and date on the BPro are correctly set (refer to the section

“Time/date mode” for details if necessary).

Step 6

Select the ABPM mode.

® ®

Press Mode/Set until the ABPM mode screen appears.

BP

Step 7

Enter the calibration setting mode.

BP

2. Press ¬/Std by to delete existing data.

1. Press and hold

Mode/Set to enter the calibration setting mode.

“dEL” will flash.

®

B P

Step 8

Input the average systolic reading into the BPro.

BP

®

B P

®

®

1. Press Mode/Set. The systolic reading will flash

BP

Step 9

Input the average diastolic reading into the BPro.

2. Press or press and hold

¬

/Std by or ▬ to set the systolic reading.

1. Press Mode/Set.

The diastolic reading will flash


B P

®

2. Press or press and hold ¬/Std by or ▬ to set the diastolic reading.

B P

®

15


Step 10

Confirm your calibration readings (e.g., 124/84).

1. Press and hold

Mode/Set to exit the setting mode and to return to the

APBM mode.

BP

®

BP

®

2. Press and hold

¬

/Std by to enter the “Std by” mode.

B P

®

Mounting the BPro on the patient

Step 11

Place your index, middle and ring fingers on the patient’s wrist to palpate the radial artery.

Note: The BPro should be mounted on the wrist of the arm from which calibration readings were taken.

Step 12

Locate the region where the radial pulse is most strongly felt, usually at the middle finger.

Step 13

Position the sensor plunger over this region, using the white marks on both sides of the sensor housing as a guide.

Note: Before mounting the BPro, you may wish to apply

Betnovate™ cream or a similar cream on the wrist area to minimize skin irritation during the ABPM session.

Step 14

While holding the plunger in place, insert the strap through the diverter, pull on the strap and fasten the Velcro. The display will show Std by and then rEAdy if the pulsations, as indicated on the pulse indicator, are acceptable. There should be at least 4 bar segments on the indicator. If necessary, re-position the plunger or adjust the strap tension until these two messages are displayed. Remind the patient to keep the wrist still.

BP

®

The BPro should not be strapped too tightly to the wrist. Otherwise, it may obstruct blood circulation and cause numbness to the hand. If the patient complains of numbness, loosen the straps.


16


Calibrating the BPro

Step 15

When the display shows rEAdy with constant pulsations and at least 4 bar segments on the pulse indicator, press the BP button to calibrate the BPro. Remember to keep the wrist still. This step will take about 12 seconds.

Pulse indicator

® ®

BP BP

Press here

Upon successful calibration, the calibration and pulse rate readings will be displayed.

Verifying the calibration

Step 16

To verify the calibration, press the BP button again within 2 minutes to activate a measurement. Remember to keep the wrist still. This step will take about 12 seconds.

If the verification is successful, the pulse rate, systolic and diastolic readings will appear and the ABPM indicator (dot) will be displayed at top left corner of the LCD. The BPro will start taking the measurements at the preset interval of 15 minutes for the next 24 hours. The indicator indicates that ABPM is in progress.

ABPM indicator

® ® ®

BP B P B P

Press here

Note: This verification must be completed within 2 minutes or otherwise CAL FAIL will be displayed and you will need to recalibrate the BPro.


17


Recalibrating the BPro

Step 17

Either of the following messages may appear on the BPro during the verification:

POS AdJ: This message could have resulted from wrist motion or improper sensor position during verification. Adjust the sensor position if necessary, keep the wrist still and then press the BP button again.

CAL FAIL: This message appears possibly because the readings are NOT within

±10 mmHg of the calibration readings, which could have resulted from wrist motion or improper sensor position during verification. Adjust the sensor position if necessary and recalibrate the BPro, as follows:

` Press Mode/Set until the ABPM mode screen appears.

` In ABPM mode, press and hold ¬/Std by to enter the calibration mode. POS and Std by will appear.

` Repeat steps 15 and 16 to complete the recalibration.

®

Press and hold ¬/Std by to enter the calibration mode.

®

BP BP


18


Flowchart for starting an ABPM session

Select

ABPM mode

Go to calibration setting mode

Set systolic reading

Set diastolic reading

Return to

ABPM mode

Enter “Std by” mode

Keep wrist still and wait for “rEAdy” to display

Put on

BPro

Enter “Std by” mode

Return to

ABPM mode

Press BP button to start calibration

No

Verification OK?

Yes

Proceed with ABPM session

Keep wrist still for at least 12 seconds

Press BP button to verify the calibration

Calibration and pulse rate readings will be displayed upon successful calibration

BPro successfully calibrated

Things to note during an ABPM session

1. The BPro will automatically trigger measurements at the preset interval and give off 3 alarm beeps 3 seconds before starting each measurement.

2. Whenever possible, keep the wrist still during each measurement until the measurement is complete.

3. The BPro will display the record number rEC (3, 4, 5, 6 … 96) after each measurement.

4. If the BPro is unable to obtain a valid blood pressure reading, it will produce a long beep and then activate a second measurement cycle. If this second attempt fails again, it will activate a third measurement cycle.

5. The BPro has been programmed to repeat this 3-cycle sequence two more times, with an interval of one minute between sequences, if no valid readings are obtained.

6. If the BPro is unable to obtain valid blood pressure readings after a 3-cycle sequence, it will display POS AdJ. You will have one minute to adjust the sensor position before the next measurement cycle is activated. An event code is stored if a measurement is unsuccessful or errors are detected.


19


Information for patients

Introduction

This section is provided for the patient’s use for ambulatory blood pressure monitoring applications.

Your doctor has selected the BPro ambulatory blood pressure monitor to measure your blood pressure for 24 hour period. The BPro is a convenient way to record blood pressure that looks like and is applied like a wrist watch. BPro allows you to continue with your normal activities while recording your blood pressure at regular time intervals.

What is ambulatory blood pressure monitoring (ABPM)?

Blood pressure is the force of the blood pushing against the walls of the arteries. Each time the heart beats it pumps blood into the arteries. Blood pressure is usually represented as SBP/DBP. Systolic blood pressure (SBP) is the pressure in your blood vessels when your heart contracts. Diastolic blood pressure (DBP) is the pressure in your blood vessels when your heart relaxes.

Your blood pressure may rise and fall in a natural rhythm during the day and night.

Ambulatory blood pressure monitoring (ABPM) refers to the collection of the overall pattern of your blood pressure over a 24-hour period. Knowledge of your blood pressure pattern helps your physician to better understand and support your overall health.

The BPro divides the day and night bands as follows –

Day band

Time (hrs)

0800-2000

Duration

12 hours

Night band 0000-0600 6 hours

The specified day and night bands are not user adjustable.

Information for the patient

20


Precautions for using BPro

DO keep the wrist still for about 12–15 seconds during measurements for optimal results. There will be 3 beeps to alert you just before a measurement cycle starts. Just relax, hold your wrist still, and breathe normally.

DO try to keep a safe distance of 0.5 to 1 meter (1.6 to 3.3 ft) between the BPro and sources of electromagnetic radiation such as microwave oven, television or mobile phones when measuring blood pressure. For more details, refer to the manufacturer’s

EMC declaration in this manual.

DO NOT apply the BPro to injured or irritated skin. Contact your physician if you experience any skin problem.

DO NOT engage in any vigorous activity during the ABPM session.

DO NOT subject the BPro to extreme temperatures, humidity or direct sunlight.

DO NOT immerse the BPro in water. The BPro is mildly water-resistant (IPX2). Use a dry cloth to wipe the BPro if it gets wet.

DO NOT set or reset the time or any ABPM settings during the monitoring period.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or any other licensed healthcare practitioner.


21


Removing the BPro temporarily

It is recommended that you do not remove the BPro during the 24-hour session, and to sponge your body clean instead of bathing or showering. However, if you have to remove the BPro for any reason, please take care to strap it back in the original location. Please also note the removal and replacement in the activity log below.

Activity log

You are advised to keep a log of your activities during the ABPM session, such as the following:

What medications you took and when you took them

When you took your meals

When you removed the BPro from your wrist and when you strapped it back

What physical or mental activities you were engaged in when measurements were being taken

When you slept and when you woke up

This log will help your physician interpret the ABPM data. You may use the log format shown on the next page.


22


Patient name/ID number:

Date Time Medication


Activity/Comments

23


Terminating an ABPM session

The ABPM indicator (dot) at top left corner of the LCD screen indicates that an ABPM session is progress. It will disappear once the session is completed or terminated. The

ABPM session will stop automatically after 24 hours.

To terminate an ABPM session before it is completed, you can simply remove the BPro from the wrist and put it aside. The BPro will continue to attempt to take measurements even though it has been removed. It will beep during these attempts but you can simply ignore the beeps. If you do not wish to be disturbed by the beeps, complete the steps below. Either way, the data that have already been captured will be retained by the BPro.

Step 1

Select the ABPM mode. The display will switch between the calibration readings and the time of calibration.

ABPM indicator

Pulse rate at time of calibration

Date of calibration

® ®

Press Mode/Set until the ABPM mode screen appears.

BP

Calibration readings

BP

Time of calibration

Step 2

®

BP

2. Press and hold BP. The ABPM indicator at the top left corner will disappear and the ABPM session will be terminated.

1. Press and hold

Mode/Set.

Step 3

Indicator has disappeared.

®

Press and hold

Mode/Set to return to the ABPM mode.

BP BP

®

BP

®


24


After an ABPM session

Downloading ABPM data to a computer

Step 1

Install the BProSOft software on a computer. Refer to the BProSOft user manual for detailed instructions.

Step 2

Plug the USB connector of the BPro USB data cable into a USB port of the computer.

Step 3

Snap the cap at other end of the cable onto the BPro, as follows:

Lift up the latch

Hold cap at a slight angle

Align contact pins with COM port a) Lift up the latch on the cap of the BPro

USB data cable. Align the 3 contact pins with the communications port by holding the cap at a slight angle off the BPro’s face.

b) Press the cap against the face of the

BPro. Ensure that the cap is flushed with the BPro.

c) Push down the latch to secure the cap to the BPro.

d) A click sound will be heard once the cap is latched properly. The latch will flush with the rim of the cap.

Step 4

If necessary, activate or re-activate the BPro. Refer to the BProSOft user manual for detailed instructions.

Step 5

Press the Mode/Set button to select PC Conn mode.

After an ABPM session

25


Step 6

Start the BProSOft software and click the Download icon.

Step 7

Close the dialog box once the download is complete.

Note: Refer to the BProSOft user manual for complete instructions on downloading ABPM data to a computer, data analysis, data storage and report generation.

Deleting ABPM data

Complete the following sequence to delete all ABPM data:

® ® ®

1. Press Mode/Set to go to the

ABPM mode.

The calibration time and readings will flash alternately.

BP

2. Press Mode/Set until “Log dEL” appears.

BP B P

3. Press ¬/Std by to delete ABPM data.

® ®

4. Press and hold

Mode/Set to exit the setting mode and return to the

ABPM mode.

BP BP

®

BP

The ABPM data are now deleted and the BPro is ready for the next ABPM session.

After an ABPM session

26


Maintenance and servicing

Battery replacement

1. Insert a coin of an appropriate size into the slot as shown.

2. Turn the battery cover with the coin in an anticlockwise direction until the cover pops out.

3. Remove the battery and insert a new one. Ensure that the positive polarity

(“+” sign) is facing up.

4. Put back the cover and using the coin, turn it in a clockwise direction until it locks.

Note: Remember to reset the time after every battery change.

1. The BPro will not operate properly if the battery is not properly installed.

2. Use only a CR2032 3 V lithium coin-cell battery.

Maintenance and servicing

27


Strap removal

Spring bar removal tool

Spring bar

C-bracket

Pointed end

1. Insert the pointed end of the strap changing tool into one of the

C-bracket holes holding the spring bar.

Strap installation

2. Push in the tip of the tool and gently pull the strap away from the end of the

C-bracket.

Fork

1. Insert one end of the spring bar diagonally into one of the C-bracket holes.

2. Insert the fork of the strap changing tool onto the top end groove of the spring bar and press it down. Slowly move the bar into position and then release the fork. A click sound will be heard if the spring bar locks into position with the hole of the C-bracket.

Give the strap a gentle pull. If the spring bar does not dislodge, it means that the strap has been properly installed.


28


Cleaning the BPro

The BPro LCD housing and parts may be wiped with a clean, moist cloth to remove surface grime. It is recommended to clean the patient contact surfaces between use by different patients to maintain hygiene. The following method is recommended.

Cleaning agents

ASEPTI-zyme

®

TRIAD

®

(ECOLAB Inc.) or equivalent enzymatic cleaner medium alcohol prep pad (70% isopropyl alcohol pad or equivalent)

Cleaning steps

Clean and disinfect the BPro patient contact surfaces including the back case cushion, straps, sensor case cushion, and plunger, as follows.

1. Wipe the surfaces thoroughly with a cotton wool moistened with ASEPTI-zyme cleaning solution.

2. Wipe the surfaces thoroughly with a clean cotton wool moistened with clean water to remove ASEPTI-zyme.

3. Disinfect and wipe the BPro with an alcohol prep pad. Allow to air dry before use.

Note: Do not allow moisture to enter the LCD or sensor housing during any of the above steps.

Illustrations

Cleaning the LCD housing and sensor housing

1. Wipe with clean cotton wool moistened with ASEPTI-zyme.

3. Disinfect with isopropyl alcohol prep pad and air dry.


2. Wipe with clean cotton wool moistened with clean water to remove

ASEPTI-zyme.

29


Cleaning the strap

1. Wipe with clean cotton wool moistened with ASEPTI-zyme.

2. Wipe with clean cotton wool moistened with clean water to remove

ASEPTI-zyme.

3. Disinfect with isopropyl alcohol prep pad and air dry.

Servicing

The BPro is not serviceable by the user. If you encounter any technical problem with the

BPro, please contact HealthSTATS or an authorized agent.

The pressure sensor of the BPro has to be tested every two years to ensure correct functioning and accuracy of the device. Contact HealthSTATS or an authorized agent for details.


30


Troubleshooting guide

Description

No pulsation bar

Possible cause Corrective action

Sensor not in ideal position to take readings.

a) Adjust the sensor so that the plunger rests on the spot with the strongest pulsations

(refer to the section

“Mounting the BPro on the patient”). b)

If the problem persists, please contact

HealthSTATS or an authorized agent.

Full bar, non-pulsating

Signal over-saturation. You may have strapped the

BPro too tightly.

a) Loosen or re-strap your

BPro (refer to the section

“Mounting the BPro on the patient”). b) Give the plunger a light tap to dislodge any particle that may have hindered its movement. c)

If the problem persists, please contact

HealthSTATS or an authorized agent.

a) You may have moved your wrist while readings were being taken. b)

Your BPro may have shifted position since the last BP measurement.

No existing historical BP records.

Keep your wrist still during measurements. Re-adjust or restrap your BPro (refer to the section “Mounting the BPro on the patient”).

Records are available only when you have successfully calibrated your BPro and taken

BP readings.

Troubleshooting guide

31


Blank LCD

Low-battery level.

Battery is flat.

Replace with new battery.

Replace with new battery.

Troubleshooting guide

32


Safety and accuracy of the BPro

Electrical safety

The BPro has been tested to meet the electrical and electromagnetic safety requirements of the following standards:

IEC 60601-1 Medical electrical equipment. General requirements for safety.

IEC 60601-1-1 Medical electrical equipment. General requirements for safety.

Collateral standard. Safety requirements for medical electrical systems.

IEC 60601-1-2 Medical electrical equipment. General requirements for safety.

Collateral standard. Electromagnetic compatibility. Requirements and tests.

Refer also to the section “Manufacturer’s EMC declaration”.

Accuracy

The BPro fulfills the provisions of the EC directive 93/42/EEC (Medical Device Directive) and conforms to the requirements of European and USFDA standards on noninvasive sphygmomanometers, in particular, the Requirements and test for non-automated measurement type and the Supplementary requirements for electromechanical blood pressure measuring systems. Refer to specifications for the standards.

The BPro has been clinically validated on subjects with the following blood pressure distribution:

Systolic blood pressure

Diastolic blood pressure

Range

> 160 mmHg

< 100 mmHg

> 100 mmHg

< 60 mmHg

Percentage of patients

16.9%

10.1%

12.4%

10.1%

ANSI/AAMI/EN/ISO

81060-1 minimum requirements

10%

10%

10%

10%

The arm circumferences of the subjects ranged from 20 to 48 cm (7.9 to 18.9 in.). The wrist circumferences ranged from 13 to 21 cm (5.1 to 8.3 in.).

Safety and accuracy of the BPro

33


Manufacturer’s EMC declaration

Manufacturer’s declaration — electromagnetic emissions

The BPro is intended for use in the electromagnetic environment specified below. The customer or the user of the BPro should ensure that it is used in such an environment.

Emissions test

RF emissions:

CISPR 11

RF emissions:

CISPR 11

Compliance

Group 1

Class B

Electromagnetic environment (guidance)

The BPro uses RF energy only for its internal functions. Therefore, RF emissions are very low and are not likely to cause any interference to nearby electronic equipment.

The BPro is suitable in all establishments, including domestic establishments and those directly connected to public low-voltage power supply network that supplies buildings used for domestic purposes.

The BPro is suitable for use with approved BP calibrators, the BProSOft

24-hour ABPM application software, and approved accessories. It is not suitable for interconnection with other equipment.

Manufacturer’s declaration — electromagnetic immunity

The BPro is intended for use in the electromagnetic environment specified below. The customer or the user of the BPro should ensure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level

Electromagnetic environment (guidance)

Electrostatic discharge

(ESD): IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV

±8 kV

Magnetic field power frequency: 50/60 Hz

3 A/m 3 A/m

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Magnetic field:

IEC 61000-4-8

Conducted RF:

IEC 61000-4-6

10 V

Portable and mobile communications equipment should be used no closer to any part of the BPro, including cables, than the recommended separation distance, d, calculated from the equation applicable to the frequency of the transmitter, as follows:

d

= (3.5/10)√P meters

Radiated RF:

IEC 61000-4-3

10 V

RMS

:

150 kHz to 80 MHz

10 V/m for lifesupporting:

150 kHz to 80 MHz inside ISM bands

10 V/m:

80 MHz to 2.5 GHz

10 V/m for lifesupporting

10 V/m

d d

= (3.5/10)√P meters for 80 MHz to 800 MHz

= (7/10)√P meters for 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a

, should be less than the compliance level in each frequency range b

.

Interference may occur in the vicinity of equipment marked with the following symbol:

Manufacturer’s EMC declaration

34


Manufacturer’s declaration — electromagnetic immunity

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BPro is used exceeds the applicable RF compliance level above, the BPro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BPro. b

Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Manufacturer’s EMC declaration

35


Specifications

General

Model

Display

Power source

Battery life

Control buttons

T6200 series

LCD, 20 x 15 mm, 2 lines

CR 2032 3-volt lithium coin-cell battery

1 to 6 months depending on usage

Mode/Set

¬/Std by

▬

BP

Display

Ambulatory blood pressure monitoring (ABPM) mode

Pulse rate range

Dimensions and Weight

Watch head

Sensor housing

Weight

Others

Operating conditions

Systolic pressure in mmHg

Diastolic pressure in mmHg

Pulse rate in beats/minute

Pulsation bar Pulse wave analysis (PWA) mode

Memory (for ABPM)

Blood Pressure Measurement

Measurement method

Measurement site

96 blocks of waveform

Modified applanation tonometry

Radial artery at the wrist (left or right)

Calibration method Oscillometric, performed before use

Measurement time (for ABPM) 8 seconds per block of waveform

Blood pressure range 40 to 280 mmHg

30 to 180 beats/minute

44 [W] x 51 [L] x 19 [H] mm

32 [W] x 38 [L] x 16 [H] mm

Approximately 50 grams with battery

Storage conditions

Fastening straps

10 to 40° C

15% to 90% relative humidity (noncondensing)

80 to 106 kPa atmospheric pressure

-20 to 50° C

10% to 95% relative humidity (noncondensing)

Fastening strap, 95 mm (3.7 in.), for wrist circumferences 130 to 150 mm (5.1 to 5.9 in.)



Fastening strap, 185 mm (7.3 in.), for wrist circumferences 210 and larger (7.3 in. and

Specifications

36


larger)

Note: Straps not included in the components list can be purchased separately.

Regulatory compliance

Performance

ANSI / AAMI / EN / ISO 81060-1

Safety

IEC 60601-1

IEC 60601-1-2

IEC 60601-2-30

Environmental

MIL-STD-810F (2000)

IEC 60068-2-6

IEC 60068-2-27

IEC 60068-2-64

EN 60529

Note:

The above specifications are subject to change without notice.

*The BPro may not meet its accuracy specifications if stored or operated outside the specified temperature and humidity ranges.

Specifications

37


Option to select other similar devices

Alternative devices similar to the BPro are available in most markets. Users are advised to check the specifications of alternative devices.

Option to select other similar devices

38


Residual risk evaluation

Possible threat through residual risks

Re-and/or cross infection;

Inability to maintain hygiene safety

Inadequate labeling; inadequate specification of pre-use checks

Means to risk avoidance/reduction

Patient contact surfaces can be disinfected. User instructions describe cleaning/disinfection.

Device labeling lists pre-use check of device, calibrator, cuff, serial cable, and battery.

Risk

Acceptability

acceptable acceptable

Risks

39


Replaceable consumable components

No.

1

Part Description

Sensor Cushion

2 Leather fastening strap, 95 mm

3 Leather fastening strap,125 mm



Part Number

P3604A

P3503A

P3505A

P3504A

P3509A

Replacements

40


Glossary

Blood pressure (BP) Sometimes referred to as arterial blood pressure, is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs.

Diastolic pressure

It is the pressure that is exerted on the walls of the various arteries around the body in between heart beats when the heart is relaxed.

Systolic pressure

It measures the amount of pressure that blood exerts on arteries and vessels while the heart is beating.

Risks, Replacements and Glossary

41

No results