Operator`s manual - Williams Medical Supplies
Contents
1. 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 Information for the patient 22 BPro operator s manual Patient name ID number Date Time Medication Activity Comments Information for the patient BPro operator s manual 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 be2. lt systolic reading will 7 flash Step 9 Input the average diastolic reading into the BPro Press or press and hold Std by or to set the diastolic reading 1 Press Mode Set The diastolic reading will flash G Starting an ABPM session 15 BPro operator s manual Step 10 Confirm your calibration readings e g 124 84 1 Press and hold Mode Set to exit the setting mode and to MX return to the is APBM mode 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 stra
3. operator s manual oo Low battery level Replace with new battery Blank LCD Battery is flat Replace with new battery Troubleshooting guide 32 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 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 P rc ntade of ANSI AAMI EN ISO Range nag 81060 1 patients i minimum requirements gt 160 mmHg 16 9 10 Systol
4. 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 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 us
5. in a clockwise direction until it 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 Maintenance and servicing 27 BPro operator s manual Strap removal P Spring bar removal tool r 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 b 1 Insert one end of the spring bar diagonally into one of the C bracket holes Maintenance and servicing 2 Spring bar E 2 Push in the tip of the tool and gently pull the strap away from the end of the C bracket 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 BPro operator s manual 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
6. the backlight for 5 seconds Features and functions of the BPro 11 BPro operator s manual ABPM mode parameters Fixed parameters The measurement interval is fixed at 15 minutes This will yield 96 measurements over 24 hours Sampling duration 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 Sampling rate 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 pudible aiens Denoted by a bell icon S 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 Y 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 3 short beeps during ABPM session just before the BPro takes a begins blood pressure measurement Measurement 1 long beep during ABPM session when the BPro needs to re take repeats a blood pressure
7. 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 Heal hSTATS 93 95 Gloucester Place Enhancing life Be Pro active W1U 6JQ London EVBP Phone 442074878468 us ratonted Fax 442074878469 Operator s manual IMPORTANT Please read this operator s manual carefully before using the BPro Pro 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
8. brator 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 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 Press Mode Set until the ABPM mode screen appears Step 7 Enter the calibration setting mode 2 Press Std by to delete existing data 1 Press and hold Mode Set to enter the calibration setting mode dEL will flash we Step 8 Input the average systolic reading into the BPro 2 Press or press and hold Std by or to set the systolic reading 1 Press Mode Set The WO
9. circumferences 210 and larger 7 3 in and Specifications BPro operator s manual 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 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 38 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 acceptable specification of pre use checks of device calibrator cuff serial cable and battery Risks 39 BPro operator s manual Replac
10. eable consumable components No Part Description Part Number 1 Sensor Cushion P3604A 2 Leather fastening strap 95 mm P3503A 3 Leather fastening strap 125 mm P3505A 4 Leather fastening strap 155 mm P3504A 5 Leather fastening strap 185 mm P3509A Replacements 40 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 Systolic pressure It measures the amount of pressure that blood exerts on arteries and vessels while the heart is beating C Eoo K Risks Replacements and Glossary 41
11. easuring 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 DONOT 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 DONOT 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 gt 13 cm It is not suitable for use on ch
12. ed 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 BPro operator s manual 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 2 Press Mode Set The calibration until Log dEL time and appears readings will flash alternately 3 Press Std by to Pea delete 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 26 BPro operator s manual Maintenance and servicing Battery replacement Insert a coin of an appropriate size 2 Turn the battery cover with the coin in into the slot as shown an anticlockwise direction until the F cover pops out F e 3 Remove the battery and insert a new 4 Put back the cover and using the coin one Ensure that the positive polarity turn it
13. el as an aid to diagnosis and treatment Introduction and indications for use 2 BPro operator s manual Symbols No Symbol Description 1 This product complies with the European Council Directive 0197 93 42 EEC Medical Device Directive 2 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 OAO OMHELS oF 10 Important information to note 11 Use by 12 Li Lot number 13 This product and its package do not contain natural rubber latex 14 PN Part number 15 ISN Serial number Symbols BPro operator s manual 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 m
14. el in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol W Manufacturer s EMC declaration 34 BPro operator s manual 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 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 Over the frequency range of 150 kHz to 80 MHz field strengths should be less than 3 V m Manufacturer s EMC declaration 35 BPro operator s manual Specifications Model T6200 series Display LCD 20 x 15 mm 2 lines Power source CR 2032 3 volt lithium coin cell battery Batter
15. ibration No Verification OK Press BP button to verify BPro the calibration successfully calibrated Yes Proceed with ABPM session 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 Ifthe 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 Ifthe 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 Starting an ABPM session 19 BPro operator s manual 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 ambu
16. ic blood pressure lt 100 mmHg 10 1 10 gt 100 mmHg 12 4 10 Diastolic blood pressure lt 60 mmHg 10 1 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 BPro operator s manual 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 CISPR 11 Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The BPro uses RF energy only for its internal functions Therefore RF CISPR 11 emissions are very low and are not likely to cause any interference to nearby electronic equipment RF emissions Class B 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 s
17. ide 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 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 BPro operator s manual Features and functions of the BPro Identification of parts LCD housing Backlit LCD BP button Communications port a A OO N gt Control button Std by Mode Set and Strap diverter O Back case cushion Fastening strap Features and functions of the BPro 10 11 12 13 15 16 C bracket Strap loop Sensor housing Sensor plunger Sensor positioning marker Sensor case cushion Connecting strap Sensor support strap BPro operator s manual Control buttons Mode Set Select operating mode Enter and exit setting mode Select and set parameter in setting mode NG Turn audible beep alerts ON or OFF for ABPM session only Illuminate backlight for 5 seconds Std by 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 Std by button Communications port button BP button Fea
18. ildren or patients with wrist circumference lt 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 BPro operator s manual 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 prov
19. ing 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 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 36 38 39 40 41 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 h
20. is recommended Cleaning agents m ASEPTI zyme ECOLAB Inc or equivalent enzymatic cleaner TRIAD 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 2 Wipe with clean cotton wool moistened with ASEPTI zyme moistened with clean water to remove ASEPTI zyme 3 Disinfect with isopropyl alcohol prep pad and air dry Maintenance and servicing 29 BPro operator s manual Cleaning the strap 1 Wipe with clean cotton wool 2 Wipe with clean cotton wool moistened with ASEPTI zyme 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 sen
21. l 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 Information for the patient 21 BPro operator s manual 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
22. latory 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 Time hrs Duration Day band 0800 2000 12 hours Night band 0000 0600 6 hours The specified day and night bands are not user adjustable Information for the patient 20 BPro operator s manual Precautions for using BPro DO keep the wrist still for about 12 15 seconds during measurements for optima
23. 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 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 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 rAl 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 personn
24. measurement May occur up to two times Measurement 1 short beep during ABPM session to indicate that the complete measurement is complete The user has the option to turn the audible alerts ON or OFF at anytime in any mode Features and functions of the BPro 12 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 aa information on how to replace a batt Features and functions of the BPro BPro operator s manual 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 Strap length 13 0 15 0 cm 95 mm 3 7 in small 15 0 17 0 cm 125 mm 4 9 in medium 17 0 21 0 cm 155 mm 6 1 in large gt 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 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 cali
25. nd day setting mode e Press or press and e Press to switch hold to decrease between parameters value The audible alerts apply to ABPM sessions only Time and date setting sequence Features and functions of the BPro 10 BPro operator s manual 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 Std by e Press to change setting or delete log e Press or press and hold to increase value e Press and hold to enter or exit the calibration and verification mode VY e Press to turn the audible alerts ON or OFF Q e Press and hold to 4 illuminate backlight Mode Set e Press and hold to enter or exit the setting mode e Press to switch between parameters Dy e Press to change setting Press or press and hold to decrease value BP e Press to calibrate verify and start ABPM session e 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 Y to turn the audible alerts ON or OFF or to illuminate
26. ours 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 rAl 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 rAl 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
27. p tension until these two messages are displayed Remind the patient to keep the wrist still 2 Press and hold Std by to enter the Std by mode obstruct blood circulation and cause numbness to the hand If the patient A The BPro should not be strapped too tightly to the wrist Otherwise it may complains of numbness loosen the straps Starting an ABPM session BPro operator s manual 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 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 Press here Note This verification must be completed within 2 minutes or otherwise CAL FAIL will be displayed and you will need
28. pecified below The customer or the user of the BPro should ensure that it is used in such an environment 10 V m for life supporting Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance level Electrostatic discharge 6 kV contact 6 kV Floors should be wood concrete or ceramic ESD IEC 61000 4 2 8 kV air 8 kV tile If floors are covered with synthetic material the relative humidity should be at least 30 Magnetic field power 3 A m 3 A m Power frequency magnetic fields should be at frequency 50 60 Hz levels characteristic of a typical location in a a ost typical commercial or hospital environment Magnetic field IEC 61000 4 8 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 Conducted RF 10 Vams 10 V d 3 5 10 VP meters IEC 61000 4 6 150 kHz to 80 MHz 10 V m for life supporting 150 kHz to 80 MHz inside ISM bands Radiated RF 10 V m 10 V m d 3 5 10 VP meters for 80 MHz to 800 MHz IEC 61000 4 3 80 MHZ to 2 5 GHz d 7 10 VP 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 should be less than the compliance lev
29. retained by the BPro Step 1 Select the ABPM mode The display will switch between the calibration readings and the time of calibration Pulse rate at time of calibration Date of calibration ABPM indicator Press Mode Set until the ABPM mode screen __w Time of SPRER SE ane calibration Step 2 1 Press and hold A Q 2 Press and hold BP The ABPM Mode Set indicator at the top left corner will disappear and the ABPM session will be terminated Step 3 Indicator has disappeared Press and hold Mode Set to return T to the ABPM mode Information for the patient 24 BPro operator s manual 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 ith COM port a Lift up the latch on the cap of the BPro b Press the cap against the face of the USB data cable Align the 3 contact BPro Ensure that the cap is flushed pins with the communications port by with the BPro holding the cap at a slight angle off the BPro s face O c Push down the latch to secure the cap d A click sound will be heard once the to the BPro cap is latch
30. sor 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 Maintenance and servicing 30 BPro operator s manual Troubleshooting guide Description Possible cause Corrective action No pulsation bar Sensor not in ideal position a Adjust the sensor so that the to take readings plunger rests on the spot with the strongest pulsations Bi refer to the section re Mounting the BPro on the D patient o bl If the problem persists a please contact HealthSTATS or an authorized agent Full bar non pulsating Signal over saturation You Loosen or re strap your may have strapped the BPro refer to the section BPro too tightly Mounting the BPro on the patient Give the plunger a light tap to dislodge any particle that may have hindered its movement If the problem persists please contact HealthSTATS or an authorized agent a 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 b Your BPro may have the patient shifted position since the last BP measurement No existing historical BP Records are available only records when you have successfully HST BP calibrated your BPro and taken BP readings oe o o e Troubleshooting guide 31 BPro
31. to recalibrate the BPro Starting an ABPM session 17 BPro operator s manual 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 gt Press Mode Set until the ABPM mode screen appears gt In ABPM mode press and hold Std by to enter the calibration mode POS and Std by will appear gt Repeat steps 15 and 16 to complete the recalibration Press and hold Std by to enter the calibration Starting an ABPM session BPro operator s manual Flowchart for starting an ABPM session Go to Set Set Return to calibration systolic diastolic ABPM setting mode reading reading mode Keep wrist still and Enter Std by wait for rEAdy to Put on Enter Std mode display BPro by mode Return to Press BP Keep wrist still Calibration and pulse rate ABPM mode button to start for at least 12 readings will be displayed calibration seconds upon successful cal
32. tures and functions of the BPro 8 BPro operator s manual Operating modes Time date mode Set time and date 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 Features and functions of the BPro 9 BPro operator s manual 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 e Press and hold to switch between seconds and day e Press or press and hold to increase e Press to turn the audible alerts ON or OFF e Press and hold to illuminate backlight value e Press and hold to On e Press to show month enter or exit the a
33. y life 1 to 6 months depending on usage Control buttons Display Ambulatory blood pressure monitoring ABPM mode Mode Set Std by BP Systolic pressure in mmHg Diastolic pressure in mmHg Pulse rate in beats minute Pulse wave analysis PWA mode Pulsation bar Memory for ABPM Blood Pressure Measurement Measurement method 96 blocks of waveform Modified applanation tonometry Measurement site 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 Pulse rate range Dimensions and Weight Watch head 30 to 180 beats minute 44 W x 51 L x 19 H mm Sensor housing 32 W x 38 L x 16 H mm Weight Operating conditions Approximately 50 grams with battery 10 to 40 C 15 to 90 relative humidity non condensing 80 to 106 kPa atmospheric pressure Storage conditions 20 to 50 C 10 to 95 relative humidity non condensing Fastening straps Fastening strap 95 mm 3 7 in for wrist circumferences 130 to 150 mm 5 1 to 5 9 in Fastening strap 125 mm 4 9 in for wrist circumferences 150 to 170 mm 5 9 to 6 7 in Fastening strap 155 mm 6 1 in for wrist circumferences 170 to 210 mm 6 7 to 8 3 in Fastening strap 185 mm 7 3 in for wrist
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