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5.1  Electromagnetic Compatibility 

Guidance and manufacturer’s declaration - electromagnetic emissions 

The BP+ is intended for use in the electromagnetic environment specified below.  The customer or the user of the BP+ should assure that it is used 

in such an environment. 

Emissions test 

Compliance 

Electromagnetic environment - guidance 

RF emissions 

CISPR 11 

Group 1 

The BP+ uses RF energy only for its internal function.  Therefore, its RF emissions are very low 

and not likely to cause any interference in nearby electronic equipment. 

RF emissions 

CISPR 11 

Class B 

The BP+ is suitable for use in all establishments, including domestic establishments and those 

directly connected to the public low-voltage power supply network that supplies buildings used for 

domestic purposes. 

Harmonic emissions 

IEC 61000-3-2 

Class A 

Voltage fluctuations / flicker 

emissions IEC 61000-3-3 

Complies 

The BP+ should not be used adjacent to or stacked with other equipment.  If adjacent or stacked use is necessary, the BP+ should be observed to 

verify normal operation in the configuration in which it will be used. 

Guidance and manufacturer’s declaration - electromagnetic immunity 

The BP+ is intended for use in the electromagnetic environment specified below.  The customer or the user of the BP+ should assure 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 contact 

±8 kV air 

Floors should be wood, concrete or ceramic tile.  

If floors are covered with synthetic material, the 

relative humidity should be at least 30%. 

Electrical fast 

transient / burst 

(IEC 61000-4-4) 

±2 kV for power supply lines 

±1 kV for input / output lines 

±2 kV for power supply lines 

±1 kV for input / output lines 

Mains power quality should be that of a typical 

commercial or hospital environment. 

Surge  

(IEC 61000-4-5) 

±1 kV line(s) to line(s) 

±2 kV line(s) to earth 

±1 kV line(s) to line(s) 

±2 kV line(s) to earth 

Mains power quality should be that of a typical 

commercial or hospital environment. 

Voltage dips, short 

interruptions and 

voltage variations 

on power supply 

input lines  

(IEC 61000-4-11) 

<5 % 

U

(>95 % dip in 

U

T

) for 0.5 

cycle 

40 % 

U

(60% dip in 

U

T

) for 5 cycles 

70 % 

U

(30 % dip in 

U

T

) for 25 

cycles 

<5 % 

U

(>95 % dip in 

U

T

) for 5 sec 

<5 % 

U

(>95 % dip in 

U

T

) for 0.5 

cycle 

40 % 

U

(60% dip in 

U

T

) for 5 cycles 

70 % 

U

(30 % dip in 

U

T

) for 25 

cycles 

<5 % 

U

(>95 % dip in 

U

T

) for 5 sec 

Mains power quality should be that of a typical 

commercial or hospital environment.  If the user 

of the BP+ requires continued operation during 

power mains interruptions, it is recommended 

that the BP+ be powered from an uninterruptible 

power supply. 

Power frequency 

(50/60 Hz) 

magnetic field  

(IEC 61000-4-8) 

3 A/m 

3 A/m 

Power frequency magnetic fields should be at 

levels characteristic of a typical location in a 

typical commercial or hospital environment. 

NOTE  

U

T

 is the AC mains voltage prior to application of the test level. 

Immunity test 

IEC 60601 

test level 

Compliance 

level 

Electromagnetic environment - guidance 

Conducted RF  

(IEC 61000-4-6) 

 

Radiated RF  

(IEC 61000-4-3) 

3 Vrms 

150 kHz to 

80 MHz 

 

3 V/m 

80 MHz to 

2.5 GHz 

3 V 

 

 

3 V/m 

 

Portable 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 √

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 the 

transmitter manufacturer and 

d

 is the recommended separation distance in metres (m). 

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: 

 

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 BP+ is used 

exceeds the applicable RF compliance level above, the BP+ should be observed to verify normal operation.  If abnormal performance is observed, 

additional measures may be necessary, such as re-orienting or relocating the BP+. 

b

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

 

Recommended separation distances between portable and mobile RF communications equipment and the BP+ 

The BP+ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.  The customer or user of the BP+ 

can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment 

(transmitters) and the BP+ as recommended below, according to the maximum output power of the communications equipment. 
Rated maximum output power 

of transmitter (W) 

Separation distance according to frequency of transmitter (m) 

150 kHz to 80 MHz 

d

 = 1.2 √

P

 

80 MHz to 800 MHz 

d

 = 1.2 √

P

 

800 MHz to 2.5 GHz 

d

 = 2.3 √

P

 

0.01 

0.12 

0.12 

0.23 

0.1 

0.38 

0.38 

0.73 

1.2 

1.2 

2.3 

10 

3.8 

3.8 

7.3 

100 

12 

12 

23 

For transmitters rated at a maximum output power not listed above, the recommended separation distance 

d

 in metres (m) can be estimated using 

the equation applicable to the frequency of the transmitter, where 

P

 is the maximum output power rating of the transmitter in watts (W) according to 

the transmitter manufacturer. 

NOTE 1  At 80 MHz and 800 MHz, the separation distance for 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. 

Essential Performance of the BP+ as required by IEC 60601-1-2 § 3.201.2 is defined as 1) opening of cuff pressure valves if detected cuff 

pressure exceeds 300 mmHg or 15 mmHg for more than 3 minutes; 2) no degradation of blood pressure measurement accuracy beyond 

that given in the specification. 

 

Page 30 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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