HealthSTATS BPro Operator's Manual

Radial pulse wave acquisition device

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

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

Authorized agent:

HealthSTATS Technologies (UK) Limited

93-95 Gloucester Place,

W1U 6JQ London.

Phone: +442074878468

Fax:

+442074878469

Operator's manual

IMPORTANT:

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

R a d i a l Pu l s e Wave Acqu i s i t i o n D e v i ce

Heal

hSTATS

Enhancing life Be Pro active

Table of Contents

Need help?

Do you have a question about the BPro and is the answer not in the manual?

Questions and answers

Craig

January 29, 2025

Hello. I have a B-Pro that I bought about 10 years ago. Barely been used. Is there someone that would be interested in purchasing? I live north of Boston. My cell number is 978 857 0002 craig

Summary of Contents for HealthSTATS BPro

Page 1 Operator’s manual IMPORTANT: Please read this operator’s manual carefully before using the BPro®. Authorized agent: R a d i a l Pu l s e Wave Acqu i s i t i o n D e v i ce...
Page 2 ® BPro Radial pulse wave acquisition device Operator’s manual IMPORTANT: Please read this operator’s manual carefully before using the BPro.
Page 3 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.
Page 4: Table Of 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...
Page 5 ® 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...
Page 6: 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®...
Page 7: Indications For Use
BPro® operator’s manual 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.
Page 8: Symbols
BPro® operator’s manual Symbols Symbol 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...
Page 9: Precautions For Use
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.
Page 10 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.
Page 11: Unpacking Your Bpro Package
BPro® operator’s manual 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...
Page 12: Features And Functions Of The Bpro
BPro® operator’s manual Features and functions of the BPro Identification of parts LCD housing C-bracket Backlit LCD Strap loop BP button Sensor housing Communications port Sensor plunger Control button Sensor positioning marker Sensor case cushion / Std by, ▬ , Mode/Set and...
Page 13: Control Buttons
▬ Display day of week and date (month and day) Calibrate BPro Verify calibration and start ABPM session Terminate ABPM session /Std by button button ® Communications port ▬ button Mode/Set button BP button Features and functions of the BPro...
Page 14: Operating Modes
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 PC Conn mode Download data to a computer that has BProSOft blood pressure report management software installed ®...
Page 15: Time/Date Mode
Press or press and setting mode. hold to decrease Press to switch value. between parameters. *The audible alerts apply to ABPM sessions only. Time and date setting sequence Time Seconds Minutes Hour Month Year Features and functions of the BPro...
Page 16: Abpm 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. Features and functions of the BPro...
Page 17: Abpm Mode Parameters
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:...
Page 18: Visual Alerts
BPro® operator’s manual 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.
Page 19: Starting An Abpm Session
> 21.0 cm 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.
Page 20: Preparing The Bpro For Calibration
BPro® operator’s manual 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. ® ®...
Page 21: Mounting The Bpro On The Patient
Remind the patient to keep the wrist still. 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.
Page 22: Calibrating The Bpro
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.
Page 23: Recalibrating The Bpro
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.
Page 24: Flowchart For Starting An Abpm Session
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.
Page 25: Information For The Patient
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.
Page 26: Precautions For Using The Bpro
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.
Page 27: Removing The Bpro Temporarily
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.
Page 28 BPro® operator’s manual Patient name/ID number: Date Time Medication Activity/Comments Information for the patient...
Page 29: Terminating An Abpm Session
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.
Page 30: After An Abpm Session
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:...
Page 31: Deleting Abpm Data
ABPM data. ® ® 4. Press and hold Mode/Set to exit the setting mode and return to the ABPM mode. ® The ABPM data are now deleted and the BPro is ready for the next ABPM session. After an ABPM session...
Page 32: Maintenance And Servicing
(“+” sign) is facing up. 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.
Page 33: Strap Removal
BPro® operator’s manual Strap removal Spring bar removal tool Spring bar C-bracket Pointed end 1. Insert the pointed end of the strap 2. Push in the tip of the tool and gently changing tool into one of the pull the strap away from the end of the C-bracket holes holding the spring C-bracket.
Page 34: Cleaning The Bpro
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.
Page 35: Cleaning The Strap
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.
Page 36: Troubleshooting Guide
You may have moved Keep your wrist still during your wrist while measurements. Re-adjust or re- readings were being strap your BPro (refer to the taken. section “Mounting the BPro on the patient”). Your BPro may have shifted position since the last BP measurement.
Page 37 BPro® operator’s manual Low-battery level. Replace with new battery. Blank LCD Battery is flat. Replace with new battery. Troubleshooting guide...
Page 38: Safety And Accuracy Of The Bpro
BPro® operator’s manual 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.
Page 39: Manufacturer's Emc Declaration
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...
Page 40 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.
Page 41: Specifications
BPro® operator’s manual Specifications General Model T6200 series Display LCD, 20 x 15 mm, 2 lines Power source CR 2032 3-volt lithium coin-cell battery Battery life 1 to 6 months depending on usage Control buttons Mode/Set /Std by ▬ Display...
Page 42 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...
Page 43: Option To Select Other Devices
BPro® operator’s manual 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...
Page 44: Residual Risk Evaluation
BPro® operator’s manual Residual risk evaluation Possible threat through Means to risk Risk residual risks avoidance/reduction Acceptability Re-and/or cross infection; Patient contact surfaces can be acceptable Inability to maintain hygiene disinfected. User instructions safety describe cleaning/disinfection. Inadequate labeling; inadequate Device labeling lists pre-use check...
Page 45: Replaceable Component Parts
BPro® operator’s manual Replaceable consumable components Part Description Part Number Sensor Cushion P3604A Leather fastening strap, 95 mm P3503A Leather fastening strap,125 mm P3505A Leather fastening strap,155 mm P3504A Leather fastening strap,185 mm P3509A Replacements...
Page 46: Glossary
BPro® operator’s manual 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.