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TensioMed® Arteriograph24™

 

6

 

 

Regular service is recommended by an approved agent at least every two years to maintain optimum 
performance and accuracy. 

 

Cleaning/desinfection of the cuff sleeve should happen on demand. Under the cuff a light, thin shirt can be 
worn.  

For disinfecting the cuff sleeve the recommended materials are:  

a., Alcohol based disinfectant  

b., Isopropanol (70%)  

Please follow the manufacturer's instructions for the use of these cleaners, please leave the solution to dry 
completely.  

Please  avoid  disinfecting  the  cuff  bladder  and  connected  rubber  tube.  Before  the  disinfection,  take  the 
bladder  and  the  tube  carefully  out  of  the  cuff  sleeve.  The  bladder  and  tube  may  be  damaged  by 
disinfectants. Do not place the cuff sleeve in the disinfectant material.  

Do NOT use disinfectants that leave a residue on the product or which are unsuitable for use in contact 
with skin.  

Some patients have intolerances (e.g. allergies) to disinfectants or their components. If you have such a 
patient or you are not sure, remove possible residues with careful washing. The cuff sleeve can be washed 
in a washing machine at max. 30 °C using a mild washing powder (do not spin). Do not use fabric softeners 
or  other  aids  (e.g.  disinfectant  rinses,  textile  deodorants).  For  drying  do  NOT  use  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 
defined in accordance with the general Quality Control Requirements. 

 

The device meets the requirements of next standards:  

o

 

EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers – Part 1: General requirements 

o

 

ISO 81060-2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of 
automated measurement type 

 

 

1.3. Warranty 

 

TensioMed Ltd. offers a 2-year warranty for the device. Any repair and device calibration within or beyond the warranty 
period are  performed  by TensioMed  Ltd.  in  the service  station of  the  company  (97.  Kossuth  Lajos  str.  Budapest  H-
1181). 
The instrument does not require regular maintenance during use. However, it is recommended that the instrument be 
sent to the service station 

(see below)

 of the manufacturer (TensioMed Ltd.) every 2 years for examination. 

 

Attention!

 The procedures described above can only be performed by the manufacturer! If the operation of the device 

is faulty in any way, or it is due for supervision, please contact our customer service (contact information below). Please 
do not try to repair the device or have it repaired at any other service station! 
 

 

Central office and service:  

TensioMed

 

Ltd. 

97. Kossuth Lajos str.  
Budapest H-1181 
Hungary 
Telefon:   +36 70 886 7337 

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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