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Uscom BP+, Руководство пользователя

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1  Product Overview 

Congratulations on your acquisition of the Uscom BP+.  Designed for ease of 

use, accuracy and repeatability, the BP+ will easily integrate into many different 

clinical and research environments.  The BP+ measures brachial and central 

blood pressure, and other cardiac and arterial parameters, using the cuff 

oscillometric method. 
BP+ central blood pressure measurements have been validated on patients who 

are eighteen (18) and older. 

1.1  Intended Use 

BP+ is a non-invasive, compact standalone measurement device that 

automatically measures systolic and diastolic pressure, and pulse rate in adult 

and paediatric patients.  BP+ also provides non-invasive central (aortic) systolic 

and diastolic blood pressure, augmentation index, pulse waveform and other 

parameters intended for use in adult patients. 

BP+ performs measurements using a conventional oscillometric method via a 

brachial cuff on the upper arm. 

The device is intended to be used under supervision by qualified healthcare 

personnel.  The device is not intended for operating theatre, intensive care, or 

continuous patient monitoring use. 

1.2  Contraindications 

This device is not intended for use on neonates, infants, or children under the 

age of 3 years. 

The device is not intended for operating theatre, intensive care, or continuous 

patient monitoring use. 

The device is not intended for measurement of blood pressure in subjects who 

are pregnant. 

Caution:

  BP+ should not be used on neonatal subjects. A paediatric subject 

age is 3 years or greater, an infant is considered to be less than 3 years of age.   

Caution: 

Federal (USA) law restricts this device to sale by or on order of a 

physician. 

1.3  Setting Up 

To start using the device you will need to supply power, connect an inflatable 

cuff, and insert an SD Card if you wish to save the measurement data. 

1.4  Supplying Power 

The BP+ requires DC power input to the device.  The mains power adapter 

provided with the monitor can provide the required DC power from most 

international mains power outlets from 100 to 240 VAC and 50 to 60 Hz mains 

input. 
The mains power adapter is supplied with interchangeable blades.  

Attach the 

blades that match your wall sockets. 

Insert the plug at the end of the cable attached to the AC wall adapter into the 

device in the socket indicated as the External DC input socket labelled 

.

 

Page 10 of 31 

BP+ User Manual (R7)

 

Содержание BP+

Страница 1: ...BP User s Manual Central Blood Pressure Measuring Device ...

Страница 2: ...ment including but not limited to any product specifications is subject to change without notice Uscom makes no representations or warranties of any kind concerning the contents of this document Under no circumstances will Uscom be held liable for any loss or other damages pertaining to the use of this document Uscom Limited Level 8 66 Clarence St Sydney 2000 NSW Australia T 61 2 92474144 F 61 2 9...

Страница 3: ...lse Wave Analysis 16 2 8 Settings Menu 16 2 9 Setting Inflation Target 17 2 10 Setting Date and Time 18 2 11 Selecting Language 18 2 12 Reviewing saved measurements 19 3 Theory of Operation 21 3 1 Physiology of wave reflection 21 3 2 Blood Pressure Measurement 21 3 3 Display of Pulse Waveform and Rhythm strip 22 3 4 Central Blood Pressure 22 3 5 Pulse Wave Parameters Calculations 23 4 Maintenance ...

Страница 4: ...Caution statements convey information about the potential to damage equipment produce inaccurate data or invalidate a procedure and are displayed in a dashed box with a caution symbol to the left Statements conveying helpful hints and notes are displayed with an information symbol to the left Individual instructions are displayed in blue italics with accompanying text Text displayed on the device ...

Страница 5: ...dex PR Pulse Rate Incident wave A wave propagating directly from the heart NIBP Non invasive blood pressure PC Personal computer POST Power On Self Test Reflected wave A wave propagating from a reflection site SD Secure Data type of non volatile removable storage card Slot A place to store a single measurement Pulse wave Pertaining to something above systolic for example a signal recorded at a cuf...

Страница 6: ...ood Pressure Cuff Direct current Warning consult safety information Consult instructions for use Information Caution Serial interface USB interface Do not dispose of the BP as unsorted municipal waste Manufacturer Date of manufacture Device serial number Device model number Indicates the temperature range Indicates the humidity range Table 1 Symbols on BP Page 6 of 31 BP User Manual R7 ...

Страница 7: ...rogress Menu OK Show the menu or OK Cancel measurement in progress Left Move to the previous item Cancel measurement in progress Table 2 Buttons on BP The following symbols when used in this manual refer to icons that appear on the device LCD Screen Symbol Description Secure Data SD Card inserted and ready Secure Data SD Card inserted but BP cannot use the card Table 3 BP screen icons START Page 7...

Страница 8: ... mains power adapter supplied with the BP or a genuine replacement part GlobTek Inc model GTM41060 2512 This product is intended for indoor use only Protect from excessive force or shock Do not pull output plug with excessive force Accessories and Equipment Use of accessories or equipment not approved by Uscom or not complying with safety standards equivalent to those met by the BP may lead to a r...

Страница 9: ...g the BP The operator should check by observation that operation of the BP does not result in prolonged impairment of the circulation of the blood of the patient Other Equipment Pressurisation of the cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb Caution Do not clean the BP with concentrated bleach corrosive chemicals or abrasive cleaning c...

Страница 10: ... patient monitoring use 1 2 Contraindications This device is not intended for use on neonates infants or children under the age of 3 years The device is not intended for operating theatre intensive care or continuous patient monitoring use The device is not intended for measurement of blood pressure in subjects who are pregnant Caution BP should not be used on neonatal subjects A paediatric subjec...

Страница 11: ...from a subject s arm is to remove the cuff from their arm 1 4 3 Power On Self Tests Once the device is turned on the device will load the BP application into the device internal memory During this time it will display the following screen Figure 1 Boot up screen BP will begin execution once loaded The BP initial screen will start a power on self test POST An example initial screen is shown in Figu...

Страница 12: ...should ensure that application of the cuff does not result in prolonged impairment of the circulation of blood Do not connect cuffs with luer lock connectors to Intravenous System IV 1 6 Saving Measurements The BP can store measurements if an SD Card is inserted The BP supports full size SD Cards with a storage capacity up to 32GB with FAT or FAT32 format Insert the SD Card with the logo facing up...

Страница 13: ...e correct size as indicated by the range markings on the cuff The cuff should be wrapped around the arm firmly but not tightly The artery marker on the cuff where the hose enters the cuff should be placed over the brachial artery Avoid placing the cuff over thick clothing Avoid bunching up clothing above the cuff which may partially occlude the artery To reduce the risk of cross infection and furt...

Страница 14: ...re is less than the systolic pressure the device will re inflate the cuff to a higher pressure before the controlled deflation If the BP does not successfully measure the subject s blood pressure selecting a higher or lower inflation target may help If your model of BP supports Measurement on Inflation and it successfully determines the blood pressure during inflation the device will directly infl...

Страница 15: ...preting Signal Quality The signal quality of the pulse wave measurements will be measured by the device and expressed as a Signal to Noise Ratio SNR on a logarithmic scale dB An increase in the SNR by 3 indicates a tenfold increase in the signal quality The SNR acceptability is indicated on the results screen as a text status message and can vary from Invalid Poor Acceptable Good through to Excell...

Страница 16: ...ay the Pulse Wave Analysis screen as follows Figure 7 Pulse Wave Analysis Screen 2 8 Settings Menu The BP provides a Settings menu for configuring different functions of the monitor The setting options include Inflation Target Select Language and Set Date and Time Figure 8 Settings Menu Screen Changing some setting options require a device reset as indicated by an asterisk Whenever a change is mad...

Страница 17: ...al inflation target to avoid these additional inflation cycles Press the Settings menu will be displayed Select the Inflation Target option and press The Inflation Target menu will be displayed with the current inflation target highlighted Press to confirm your selection or use the arrow keys to select another value You will be returned to the Settings screen Note that the Inflation Target will de...

Страница 18: ...ghted date time element When finished press The monitor will automatically store the changed value and does not require any reset of the monitor To return to the main screen select Save and Exit and press 2 11 Selecting Language By default the language displayed on the monitor is English The BP monitor may support different language displays for some countries Press The Settings menu will be displ...

Страница 19: ...d Select the Select Measurement option and the Select Measurement menu will be displayed If no SD Card is inserted then the device will prompt you to insert one The Select Measurement screen will display a list of measures The most recent measurement is at the top of the list indicated by the Start of List entry Use and to highlight the measurement to review The screen can display up to 7 measurem...

Страница 20: ...ill begin to reprocess the measurement after which it will be displayed on the main screen If you do not wish to open a measurement for review select Start of List or End of List and Press Figure 15 Calculating Measurement Figure 16 BP Result Screen Page 20 of 31 BP User Manual R7 ...

Страница 21: ...generated by the heart can be considered to take two paths to the upper arm cuff generating what are known as the incident wave and reflected wave The incident wave travels from the heart through the ascending aorta subclavian artery and brachial artery to reach the cuff The reflected wave travels from the heart through the ascending aorta aortic arch and down the descending aorta to the effective...

Страница 22: ...ve t1 p1 Trough between incident and reflected wave t2 p2 Peak of the reflected wave t3 p3 Trough of the dicrotic notch t4 p4 Peak following the dicrotic notch t5 p5 3 4 Central Blood Pressure The BP uses a physics based model of the subclavian to brachial artery branch to calculate central blood pressure This model has been validated against Incident wave path Reflected wave path Effective reflec...

Страница 23: ... variability milliseconds 1 2 2 1 0 1 0 2 1 sPRV N n n n t t N Suprasystolic Pulse Rate beats per minute N n n n t t N 2 1 0 0 1 1 sPR Signal to Noise Ratio decibels N n n t p t p N t p t p 1 2 2 10 1 log 10 SNR where T t dt t f T t f 0 1 Systolic ejection period milliseconds 0 4 sSEP t t Reflected wave transit time peak to peak milliseconds 1 3 p sRWTT t t Reflected wave transit time foot to foot...

Страница 24: ...d annually by a trained service technician The cuffs provided with the BP may become worn with routine use and require replacing 4 3 Cleaning The device may be cleaned using lint free cloth dampened with a mild solution of detergent and water 10 bleach solution or a commercial disinfectant After cleaning dry all areas with a lint free cloth Avoid ingress of liquid into any part of the BP or power ...

Страница 25: ...ed compressed or blocked I get the message Invalid Signal after taking a measurement This can occur when the signal is too noisy to process Ensure the cuff is applied firmly and the subject remains still during the measurement The signal is consistently very noisy SNR 6 even under ideal measurement conditions There may be a slow leak in the pneumatic circuit Check for damaged air connectors split ...

Страница 26: ... Range Exceeded Where is the error number The upper arm systolic pressure measured is too high The device cannot proceed to do the Pulse Wave measurement Unable to Calculate Results Unable to Find Features Unable to Find Pulse Wave Calculation error Unable to Reinflate The inflation target for doing the Pulse Wave measurement is too high Unable to Start Device detects an internal error when it sta...

Страница 27: ... when the device is trying to save the measurement data Insert a compatible SD card When the device is trying to save the measurement data and an invalid SD card is detected or the saving process fails Check the capacity of the SD card and make sure it is not larger than 32GB is SD or SDHC compatible and formatted as FAT or FAT32 Use a different SD Card if available When device is trying to save t...

Страница 28: ...urement data Insert a compatible SD card Repeat the measurement When device is trying to save the measurement data Oversize SD card is detected device does not support capacity larger than 32GB Check the capacity of the SD card and make sure it is not larger than 32GB When device is trying to save the measurement data SD card is full Delete the old record s or replace with an empty SD card When de...

Страница 29: ...ve waveform display Graphical rhythm strip display Status and error display SD Card slot hot swappable with cards up to 32 GB Blood pressure cuff and hose Lifetime antimicrobial treatment Small Adult Adult and Large Adult cuffs available 1 3 m hose Computer interface Computer interface specification serial port available for customer configuration Power supply Power Supply Unit GlobTek Inc model G...

Страница 30: ... and mobile RF communications equipment should be used no closer to any part of the BP including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to ...

Страница 31: ...2 cm Large Adult Cuff 32 42cm Part U50316 This is a re useable latex free cuff suitable for arm circumference 32 cm to 42cm Medical grade mains power adapter with international blade set Model Number GlobTek Inc GTM41060 2512 Part U50312 Suitable for use as supply of external DC power to the BP Comes with US Europe United Kingdom and Australia New Zealand blade set Has medical grade certification ...

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