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TensioMed® Arteriograph24™

 

21

 

Electromagnetic immunity 

The TensioMed® Arteriograph™ TD3 device is intended for use in the electromagnetic environment specified below. The customer or the 
user of the TensioMed® Arteriograph™ TD3 device should assure that it is used in such an environment. 

Immunity test 

IEC 60601 test level 

Compliance level 

Electromagnetic environment — guidance 

 

 

 

Portable 

and 

mobile 

RF 

communications 

equipment should be used no closer to any part of 
the  TensioMed®  Arteriograph™  TD3  device, 
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 – 800 MHz 
d=2,3√P 800 MHz – 2,5 GHz 
 

where 

is the maximum output power rating 

of  the  transmitter  in  watts  (W)  according  to 
the  transmitter  manufacturer  and 

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.

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

Conducted RF  
IEC 61000-4-6 

3 V

eff

 

150 kHz – 80 MHz 
 

3 V 

 

 

Radiated RF 
IEC 61000-4-3 

3 V/m 
80 MHz – 2,5 GHz 

3 V/m 

NOTE 1   At 80 MHz and 800 MHz, the higher frequency range applies. 
NOTE  2    These  guidelines  do  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 TensioMed® Arteriograph™ TD3 device is used exceeds the applicable RF compliance level above, the TensioMed® 
Arteriograph™ TD3 device should be observed to verify normal operation. If abnormal performance is observed, additional measures may 
be necessary, such as re-orienting or relocating the TensioMed® Arteriograph™ TD3 device. 

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 

TensioMed® Arteriograph™

 

TD3 device 

The TensioMed® Arteriograph™ TD3 device is intended for use in an electromagnetic environment in which radiated RF disturbances are 
controlled.  The  customer  or  the  user  of  the  TensioMed®  Arteriograph™  TD3  device  can  help  prevent 

electromagnetic 

interference  by 

maintaining

 

a  minimum  distance  between  portable  and  mobile  RF  communications  equipment  (transmitters)  and  the  TensioMed® 

Arteriograph™ device 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 – 80 MHz 

d=[3,5/3]√P 

80 MHz – 800 MHz 

d=[3,5/3]√P 

800 MHz – 2,5 GHz 

d=[7/3]√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 

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. 

 
 

Summary of Contents for ARTERIO Graph 24

Page 1: ...24hour measurement of arterial function stiffness and peripheral blood pressure With wireless communication Bluetooth Please read the user s manual carefully before the first use TensioMed Arteriograph24 03v6 00 Revised 01 07 2021 ...

Page 2: ...________________________________________________________________________________________________________________________________ TensioMed Arteriograph24 2 ...

Page 3: ... 1 Explanation of symbols 10 2 2 Accessories 12 2 3 Installing the Device 13 2 4 Operations Instructions 14 2 4 1 Functions of the button on the device 14 2 4 1 1 One short push of the button 14 2 4 1 2 Two short pushes on the button 15 2 4 1 3 Three short pushes on the button 15 2 4 1 4 Four short pushes on the button 16 2 4 2 Data transmission 16 2 4 3 Error codes for users 17 2 4 4 Sound signal...

Page 4: ...d with other instruments e g ECG respiratory rate temperature oxygen saturation this does not affect the applicability of the Arteriograph24 Do not use the device on patients if high frequency electrosurgical equipment is applied on them If the patient is in a hyperbaric oxygen chamber the Arteriograph24 should not be used If the patient has a skin disease or wound on the upper arm where the cuff ...

Page 5: ...ion All manually initiated measurements are stored and displayed on the software report The storage capacity of the device is 1000 measurements Copyright 2011 TensioMed Ltd Budapest Hungary All rights reserved Under the copyright laws this manual cannot be reproduced in any form without prior written permission of TensioMed Ltd Every effort has been made to ensure that the information in this manu...

Page 6: ...tumble dryer It is important to ensure that the disinfectant is washed off completely before setting the cuff in place Attention there must be no residual disinfectant on the blood pressure cuff before setting the cuff in place over 24 hours The Velcro must always be fastened before washing The handling storage wrapping substance conservation and transportation of the producer s devices are define...

Page 7: ...he measurement results provided by Arteriograph24 and the determination of the tasks to be performed is the responsibility of a specialist physician or a specially trained assistant with a higher education degree We have good practical experience with the use of Arteriograph24 in the adult 18 age group which is the intended use of the instrument There is no direct restriction regarding the weight ...

Page 8: ... unfavorable if the patient is not in a proper condition psychologically mentally or makes the 24h recordings impossible intentionally Do not remove the outer cover of the device The TensioMed Arteriograph24 device is sophisticated multipurpose software controlled measuring apparatus Should any operating problems occur have the device serviced by the manufacturer s service department as described ...

Page 9: ...suring periods might cause blood flow disturbances in the arm Ensure by the proper programming of the device enough time for blood flow recovery Avoid the kinking of the hose during measurement Do not use the device on an arm which is being injected with intravenous injection Do not use the device on patients suffering from blood coagulation disturbances In case if the patient had surgical operati...

Page 10: ..._____________________________________________ TensioMed Arteriograph24 10 2 The TensioMed Arteriograph24 device 2 1 Explanation of symbols The front of the device is shown in Figure 1 1 Function button Offering four menu options 2 Command symbols 3 LCD 4 Air connector Figure 1 3 1 4 2 ...

Page 11: ...ghly the present User s Manual 12 Certification mark guaranteeing that the apparatus complies with the prescriptions and requirements of the European Union 13 Serial number 14 Operating ambient temperature range 15 Year of the manufacturing 16 Head office of the Manufacturer 17 The permanently placed in unused equipment must be collected in order to get more efficient reuse and recycling as well a...

Page 12: ...t of the device that necessarily comes into physical contact with the patient during the intended use of the device to perform its function see section 2 4 5 for more information For the 3 different size cuffs the dimensions are Cuff type Bladder dimensions Sleeve dimensions Arm circumference range Cuff S 20 8 cm 41 5 10 cm 20 24 cm Cuff M 23 11 5 cm 57 14 cm 24 32 cm Cuff L 28 x 11 5 cm 64 x 14 c...

Page 13: ...he ones you think are weak The clock circuits of the device are powered by a type Ni Cd battery and it is continuously charged by the AA batteries therefore the clock time is held and resetting the time is unnecessary between battery changes If you do not intend to use the device for a long period of time remove the batteries and store them in a cool and dry place Do not apply heat to the batterie...

Page 14: ...ient if the measured value is between 6 0 V and 5 4 V for alkaline batteries and between 5 2 V and 4 6 V for rechargeable batteries If the voltage drops below 4 4V the batteries must be replaced A warning symbol of low battery appears on the LCD 5 6V LOw Batt If the battery voltage is adequate the device will be ready for measuring and the current computer time will be displayed TensioMed Arteriog...

Page 15: ...measured data including the date and exact time 128 96 PUL 68 At any time during a reading the patient can terminate the measurement by pressing once the single button A termination symbol will appear on the display for 10 sec see adjacent figure Then the time will appear and the units ready for measurement for manual and programmed mode OFF 2 4 1 2 Two short pushes on the button Pill allows the p...

Page 16: ...ta transmission The device downloads all the stored data to the physician s PC via Bluetooth communication The information loaded consists of the systolic and diastolic blood pressure values mmHg the heart rate per minute the arterial function parameters central SBP PP brachial and aortic Aix aortic PWV the distinction between programmed and manual measurements the date and time of the measurement...

Page 17: ...urement was interrupted due to the weakness of the battery 31 The cuff is not connected to the device 32 The cuff tube is broken or something got into the tube e g water 33 The cuff or device is leaking 34 The cuff is not on the patient s arm 35 The measurement was interrupted for some reason e g because the patient pressed the button 37 During the blood pressure measurement the cuff pressure has ...

Page 18: ...the hosing allows for free ambulation If the chosen cuff is appropriate to the patient s arm circumference the metal hook will be positioned between the two markers labelled white on the surface of the cuff We recommend installing the cuff onto a thin long sleeve shirt to increase comfort during wearing The tube of the cuff should be inserted into the air connector of the device see figure 1 Atten...

Page 19: ...g including batteries Blood Pressure measurement method Oscillometric Data Storage Max 1000 measurements Blood Pressure BP and heart rate HR measurement range BP 30 280 mmHg HR 40 200 min Static accuracy 3 mmHg or 2 of the measured value Measuring accuracy Systolic 94 out of 99 comparisons were within 5 mmHg 95 in case of 33 out of 33 patients 2 comparisons out of 3 were within 5 mmHg 0 out of 33 ...

Page 20: ...intended for use in the electromagnetic environment specified below The customer or the user of the TensioMed Arteriograph TD3 device 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 cera...

Page 21: ...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 TensioMed Arteriograph TD3 device is used exceeds the applicable RF compliance level above the TensioMed Arteriograph TD3 device should be observed to verify normal operation If abnormal performance is observed additiona...

Page 22: ...he body or type of tissue applied to or interacted with The cuff interacts with the skin surface of the upper arm The cuff exerts pressure on the upper arm when inflated Intended user profile Measurement schedule programmed and read from the instrument by the doctor or medical staff and measurements assessed by the doctor The device with a programmed measurement schedule is worn by the patient who...

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