User manual
Contents
1. X STENDO STENDO V3 user manual software v3 0 3 1 enei IEC 60601 l IEC 60259 Cee o o IP 20 IEC 60601 1 IEC 60417 Electrical class Yes No Electrical Class I European directive 2002 96 EC on Waste on No X Electrical and Electronic Equipment WEEE X Caution Federal Law USA i restricts this device to sale Warming KOA me ne by or on the order of a physician or licensed practitioner Made in France Restrictions of hazardous substances directive Yes No RoHs directive 2002 95 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 ensi 4 ONSITE INSTALLATION 4 1 Installer operator The unpacking and initial installation must be performed by a technician approved by STENDO member of staff of STENDO or of one of its distributors 4 2 Unpacking Console box Remove the console from its packaging Make sure that the following items are present e 1 console e 1 NIBP cuff with its tube e 1 ECG lead 5 electrodes e 1 finger pulse oximeter e 1 emergency stop wired control e 1 air tube 6mm 4mm 10m e 1 User manual Pulsating suit box Make sure that the box contains the following items e 1 right leg equipped with its tube e 1 left leg equipped with its tube Provided as optional extras 1 air tube complying with hospital standards cleaning produc2. mains interruptions it is recommended that the STENDO V3 system be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location ina typical commercial or hospital environment Page 34 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 dads 7 4 Electromagnetic immunity RF portable equipment The STENDO V3 system is intended for use in the electromagnetic environment specified below The customer or the user of the STENDO V3 system should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment guidance test level Portable and mobile RF communications equipment should be used no closer to any part of the STENDO V3 system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RE 3V d 1 2VP 80 MHz to 800 MHz adiate m B IEC 61000 4 3 80 MHz to2 5 GHz B ecyr B00 MAZ iga SCR 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
3. 0 3 1 eaei If no contraindications apply to the subject press cp Last name smith Select the time and First name john pressure specified by your therapist COdO 15 min 20 min 0 Q0 O bi ag Ji Select the time and pressure Pressure Recommended Select your synchronization mode RA gt Not recommended subject to artifacts y Select one the of the two available synchronization mode We strongly recommend selecting ECG Page 25 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 eaei If you forgot to press the reset the button the following screen appears Please check the reset of the power Simply press the reset button 13 the light has to turn green Once done the following screen appears ECG selected SPO2 selected Lie down Lie down Position the ECG or SPO2 s Position the ECG or SPO2 Grab the remote control Grab the remote control Fit the suit to your body x Ea Fit the suit to your body Stop moving A Stop moving Wait for the green light f gt r n c Wait for the green light WN s A 2 j pi TD gt TD wa Start the session i 7 X i Start the session Follow the instruction on screen and described in chapter 5 3 Lie down
4. of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 1 enn After exiting the program the operating system automatically shuts down Wait until the screen goes black then switch off the power to the console using switch 11 Page 30 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 ensi 6 IN CASE OF DIFFICULTY The console does not switch on Check that the power cable is correctly plugged to the supply socket Chapter 4 5 Check that the power switch is set to the ON position Chapter 4 5 button 11 The solenoid valve emits a continuous noise Check that the console is correctly connected to an air source that meets the recommended characteristics Chapter 4 3 and 4 4 Check that the air source is switched on The suit does not inflate Check that the suit is correctly connected to the console Chapter 4 5 Check that the console is supplied with air from an air source that meets the recommended characteristics Chapter 4 3 and 4 5 Check that the air source is switched on Windows is launched but the STENDO program l N does not start You can double click on the STENDO icon located on the Windows desktop If the problem persists please contact your distributor Pag
5. prior written consent of Stendo SAS Stendo and the Stendo logo are trademarks of Stendo SAS 2012 All rights reserved This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 enei The device has received a CB test certificate and is in conformance with the following norms IEC 60601 1 2012 IEC 60601 1 2 2007 IEC 60601 1 6 010 IEC 62366 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO V3 user manual software v3 0 3 1 arene Contents 1 DESCRIPTION OF INTENTION OF USE PERFORMANCE cccsssssssssssssccccccssssssssssssnsnscccccccccceeeees 5 VIN GS I sieniin E a ei que seencniare 5 3 MEANING OF THE LOGOS PRESENT ON THE DEVICE w ccccccccccscssccccscccsscssscecccsssssccssseseseessseeseeees 7 4 ONSITE INSTALLA TION paronin E N 9 4 1 Tostaet Operator hpc E EA 9 4 2 Unpa kino cerre r E E A 9 4 3 Operate COMGIIONS seereis E AE EE 9 4 4 TFransport and storage Conditions eiccccceccscesscsaccccnsssvexexeecescaeesavensececuorssessvosevesesseaseasatansuassvevsseneveusrssaverers 9 4 5 Inistalline the cguipment sissen aaa E EEE 10 3 OSEO SIND aeee E E E T E E R 14 5 1 Starting the Stenda SVSteM sessies aaa Eaa aeS EGSA 14 5 2 Appropriation of the graphical interfa
6. DO STENDO V3 user manual software v3 0 3 1 re 7 2 Electromagnetic Emissions The STENDO V3 system is intended for use in the electromagnetic environment specified below The customer or the user of the STENDO V3 system should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The STENDO V3 uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The STENDO V3 system is suitable for use in CISPR 11 all establishments including domestic Harmonic emissions Class A establishments and those directly connected to IEC 61000 3 2 the public low voltage power supply network Voltage fluctuations Complies that supplies buildings used for domestic Flicker emissions purposes IEC 61000 3 3 Page 33 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 7 3 Electromagnetic immunity The STENDO V3 system is intended for use in the electromagnetic environment specified below The customer or the user of the STENDO V3 system should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic dischar
7. ESENT ON THE DEVICE Application for the Application for the The name or company STENDO SAS STENDO SAS name and the address of 17 rue du Port 27400 17 rue du Port 27400 with the logo the manufacturer Louviers France Louviers France STENDO The indications strictly Name and or reference Name and or reference needed to identify the of the product of the product device and the contents of STENDO V3 and or STENDO V3 and or the packaging in particular BP600 BP600 for the users The batch code preceded Py ETETEN 7 Serial No Batch No LOT or the serial number Specific instructions for Refer to the user Refer to the user use manual manual Lower Ai suit The year of manufacture Month Year Month Year for the active devices 04 2013 04 2013 IEC 60601 1 IEC 60417 5010 on off 2 stable positions Yes Rear of the console On the emergency stop cable or on the emergency stop control IEC 60601 1 IEC 60417 5638 emergency stop IEC 60601 1 IEC 60417 Yes 5264 ON for part of Rear of the console equipment next to the reset button Mention for indoor use only IEC 60601 1 IEC 60417 5840 type BF applied part On the leads of the applied parts SpO2 Air input pressure Min 3 bar Max 6 bar Authorised input pressure This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO
8. Lie down Position the ECG or SPO2 Position the ECG or SPO2 Grab the remote control x Grab the remote control Fit the suit to your body x ba Fit the suit to your body Stop moving 7 P 4 Stop moving Wait for the green light N gt ween a Wait for the green light Start the session i k Pa Start the session Page 26 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 eaei Once the light turns green you can start the session Press the start button directly on the remote Press the start button on the screen OR Lie down Position the ECG or SPO2 Grab the remote control Fit the suit to your body Stop moving Wait for the green light C Start the session fi 7 y OQO gt lt A The session starts and the following screen appears Page 27 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 eaae 5 6 Emergency stop Resuming after stopping 5 6 1 Emergency stop As a safety measure the Stendo system is equipped with an emergency stop wired control This is handed to the subject at the beginning of the session allowing
9. O STENDO V3 user manual software v3 0 3 1 dads 7 5 Recommended separation distances The STENDO V3 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the STENDO V3 system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the STENDO V3 system as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of transmitter W d 1 2VP d 1 2VP d 2 3yP i aman mean ema 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 Page 36 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual
10. Pressing this button closes the window to which it belongs The parameter or the option takes the value defined The Cancel button is used to cancel the input of a particular parameter or the choice of a particular option Pressing this button closes the window to which it belongs and the parameter or the option to be defined keeps its old value Page 15 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 eaei 5 3 Patient preparation 5 3 1 Installing the patient in the clothing Precautions e Do not fold the lower body suit e Do not use inflate empty without the subject inside the suit e Clean the internal lining with an antiseptic wipe optional extra e Do not use any cytotoxic corrosive and allergenic cleaning products e The subject must not wear a belt or any clothing that could pierce the lower body suit metallic buttons etc or shoes e For reasons of hygiene it is recommended that the subject should wear tights leggings or similar optional extra e Place the pulsating suit flat on an examination table or dedicated area close to the console e Do not dispose of with general waste e Store flat Comment The correct adjustment of the suit according to the size of each subject is essential for optimal efficacy of the Stendo session It is important for the s
11. X STENDO STENDO V3 user manual software v3 0 3 1 enei CARE Stendo SAS STENDO V3 Software version 3 0 3 1 Stendo Care User manual Version 1 26 June 2014 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 dads CIS patents relating to the pulsating technology This device is protected by a number of patents No implicit licence The acquisition or possession of this device does not confer any explicit or implicit licence for the use of this device with spare parts that alone or combined with this device fall within the remit of one or several patents relating to this device STENDO is a registered trademark of STENDO SAS Performance of the system The procedures described in this manual must be observed in order to ensure the correct performance of the system and to avoid any danger Stendo SAS can neither supply nor verify the characteristics or the performance of the system if said system is not installed used and maintained in compliance with the procedures set out by Stendo SAS or if accessories are used that do not meet the specifications set by Stendo SAS Third party software and trademarks The STENDO system V3 includes the Microsoft Windows XP E program The use of the system implies agreement with the terms of the software licensing agreement of the suppl
12. acenec SSeSScescss aJalalulalulalwlalalalalen eSqaceacKec0n0re Feacaceoacnececeane Page 20 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 1 eave Birth date Define the gender of the subject Weight kg Page 21 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 1 ene Enter the con t about th bject ment abou e subj no comments lei a ain ain an aa a a a a a a a laslas ies as s u lu us ias ea ias as Suen ooo0o00a00008 JJ IIIA IA e Page 22 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STEND STENDO V3 user manual software v3 0 3 1 ene 5 5 Initiation and description of a session On the screen press Already registered Enter the beginning of the name NE ee a EeeceneaqeannsesS gt oOocacacaccascc Mmannacnaceane KaacnancTeee0ne Qs LX Use the keyboard on screen to enter the last name of the subject and validate the information by pressing W Select a subject in the database First Name _ _Birth_Date Gender 30 01 1967 Page 23 Thi
13. and or stimulate the natural physiological pulsations and the physical shear stress forces wall shear stress acting on the endothelial cells The system consists of A pulsating suit that amplifies blood circulation without changing the heart rate A command console The STENDO system V3 software version v3 0 3 1 is not a monitoring device electrocardiography breathing oximetry and cannot be used for diagnostic purposes The use of the Stendo system cannot replace dedicated monitoring equipment and would not be capable under any circumstances of replacing permanent monitoring of the subject The STENDO V3 device with the STENDO CARE software is designed for well being purposes only with no medical indications and is sold as is 2 WARNINGS SAFE USE The STENDO system V3 must be used exclusively by qualified staff who have been trained to use the system It is essential for the user to read this manual the user instructions for the accessories the safety measures to be complied with and the specifications before using this device A N It is absolutely prohibited to use this system on any subject fulfilling any of the following criteria e Having undergone a major surgical intervention in the year preceding the session e Having undergone a major cosmetic surgery intervention in the year preceding the session e Being pregnant e Having prohibitions and restrictions presenting a history of phlebitis or thrombosis e Simultaneousl
14. available connect the standard hospital air tube optional extra to socket 6 of the console and to the hospital supply socket Stage 3 connecting suit console APA NYA Yn Connect the tubes of the left and right legs to sockets 5 of the console no specific plug alignment necessary Simply pressing the green button allows the tubes to be detached Page 12 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 said Stage 4 attaching the console connections Connect the NIBP cuff to its tube then attached to socket 1 of the console ircumference x23 5cm li f was Connect the emergency stop control box to socket 4 of the console Connect the ECG lead to socket 2 of the console Connect the SpO2 finger pulse oximeter to socket 3 of the console Stage 5 connecting to the electricity suppl Plug the power cable to the mains supply Page 13 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 1 ees 5 USE OF STENDO 5 1 Starting the Stendo system Switch on the power to the console using switch 11 Make sure the reset button 13 is lit up green if the reset button is red press t
15. ce cccccccssssssssscccsssssssscscccccccsssssscccccsscssssssssccsssssssssssccoees 14 5 3 Patent prepar AUION sses cannesedonesuessccvecceccansdsussaseusesasxcdueusssuasesesyeteecsaqousacenseseutasesecesoauoces 16 5 3 1 Installing the patient in the clothing cccccccccccccccccccceeeeeeseseeseeeeeeceeeeeeeeeeeaaaaaeaseseeeeeeeeeeseeeeeeaaas 16 I2 Attachment machine Patent vicsccsvaveacaicssecee lt niacheensdesancneastendincensvoeneateadendabtedceveeadeacensabadeeeraseeddacenibh 19 SA DeRMMMIOM OF A SUD JCC E E A E E E E areadnieeeineeeint 20 5 5 Initiation and description OF a SESSION sssssssseseceeceosceceeecececcecesecoeeeeseeeseceseseeeseseceseeeeeessesesssesssessssee 23 5 6 Emergency stop Resuming after Stopping cccccccccccccssscsscssssssssssssscssscsssssssscsccsccccssseseeeees 28 5 6 1 Oct Bech ICON ga 0 Opener er ner reenter net ee een Re fare rent ete Tetra ee ern te ee tt ere aren ere rr een tere 28 FOZ Resuming after an emergency SLOP ercsccerosioissiieoesn erorcen ioner aiiai arani 28 5 7 Turning oll he CONS ONC isaac scccccs vacesavezccecsas Er 29 6 IN CASE OF DIFFICULTY wrsssrcceccccetcecsesnsssssucsensccoasosceacetandanessoussdecossncnoausocscee te tasoaueusedocasenateaesoasaactnaneaeee 31 Electromagnetic Compatibility Declaration 1ssssscecssccccccccccncncccccccssssssssssescceccccceescasssssssssseceeeceeeeeeeees 32 7 1 Cabes TOMO CA 5c se caacenececascacaccavcacecensesssennc
16. ctor 11 Power switch 12 Power cable 13 Reset button Page 11 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 enei Stage 1 placing the components Place the console on a flat surface Place the pulsating suit flat on an examination table see Chapter 5 6 1 The console must be fairly close to the subject and therefore to the location of the pulsating suit in such a way that the various leads connecting the subject to the console are not subjected to undue tension from any movement of the subject Lighting above and around the system must be sufficient to allow the display to be clearly seen and read Stage 2 connecting console compressed air source The console must be connected to a source of air that is clean no oil or dust and dry with a minimum flow of 50 L min and providing a minimum pressure of 3 bars and a maximum pressure of 6 bars The console has two air source connectors One is a standard hospital air source connector and the other is a 6mm 4mm tube connector external internal diameter Warning Connecting a single air supply is sufficient for the device to work properly Do not connect both air supplies at the same time Connect the 6mm 4mm air tube to socket 7 of the console then connect it to the compressor lf a standard hospital air socket is
17. e 31 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 iid 7 Electromagnetic Compatibility Declaration A N WARNING The use of accessories sensors and cables other than those specified may result in increased emissions or decreased immunity of the STENDO V3 system The STENDO V3 system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the STENDO V3 system should be observed to verify normal operation in the configuration in which it will be used 7 1 Cables length Console RF emissions CISPR 11 e Supply cord 1 8m 5 9 ft Class B Group 1 e ECG lead set 3m 9 8 ft e SpO02 2 6m 8 5 ft Harmonic emissions e Safety switch 3m 9 8 ft IEC 61000 3 2 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Page 32 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STEN
18. eusosass vase couciusaaueceanea a 32 12 El ciromacne Ne EmisstoNnS vacesesssissncecenvervadonsececsiecssveancccasoceedesvesoessdascieseeveundssssuauevervecaactiesseevesssusivineons 33 7 3 BICC OMAGHEEIC TIMTIUNIMICY sssrinin irea a EE a E 34 7 4 Electromagnetic immunity RF portable equipment ecscssssseeccccssssccecccsssssececssssssceecosssssscesossssssee 35 7 5 Recommended separation distances ssssssseccccsssssecccosssssceccccssssecoccosssscecccssssseceecsssssseecosssssseeecssssssee 36 S MUN LEVAN I oor E E ES 37 8 1 Routine maintenance of th CONS Csisscssccescsssccceessessccesccteccnscstsecesesnsacesassessebaseoasesestensessetesueseuseetessetece 37 52 Routine maintenance OF the SUM svsiiiisccecisccescctsccesecenernsietavensectucceivetatcccwctuseussstatensectucctavetatecsuetuceusiees 37 8 3 ar A E corcesceceuscoaves es veevsceaniesssvisncesueersarsvinescouse 37 8 4 KIEA O CDO a E E 37 8 5 Disposal of be devit ooo as cece vere ssescscccecacseceeecceesesescievouccsacs REEE EE EAE EEE TE EA 37 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 aide 1 DESCRIPTION OF INTENTION OF USE PERFORMANCE The objective of the Stendo device is to achieve compression decompression sessions to the lower part of the body legs thighs and abdomen in a non invasive manner in order to reproduce
19. ge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Note Uris the a c mains voltage 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Urt gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 6 kVcontact 8 kVair 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec orior to application of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the STENDO V3 system requires continued operation during power
20. ier s of any software mentioned above If the terms of the software license agreement s cannot be agreed to do not use the system but contact immediately the supplier in order to return the system and receive reimbursement of the purchase price Microsoft and Windows are trademarks of Microsoft Corporation Guarantees and non responsibility Stendo SAS does not provide any guarantee explicit or implicit except for those expressly Stipulated Any guarantee expressly stipulated in this document applies only if the system is installed used and maintained in compliance with the procedures set out by Stendo SAS and only if accessories are used that meet the specifications provided by Stendo SAS Stendo SAS refuses to accept any responsibility regarding the performance of the system if said system has not been installed used and maintained in compliance with the procedures set out by Stendo SAS or if accessories are used that do not meet the specifications provided by Stendo SAS Furthermore Stendo SAS refuses to accept any responsibility for loss of data and direct or indirect consequences thereof including economic and commercial losses whether such compensation requests are based on a contract negligence or damage including strict responsibility and even if Stendo SAS has knowledge of the potentiality of the damage or loss Confidentiality The contents of this document must not be reproduced or communicated to a third party without the
21. in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol M 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 STENDO V3 system is used exceeds the applicable RF compliance level above the STENDO V3 system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the STENDO V3 system NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 35 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STEND
22. o reset 5 2 Appropriation of the graphical interface The STENDO CARE software was specifically designed to ensure the easy control and command of the STENDO pulsating suit It was designed to execute under the Microsoft Windows operating system Once the console is switched on and after the operating system is launched the STENDO software starts up automatically The graphical interface of the STENDO software was designed to be viewed on a screen in full screen mode and to be used with a touchscreen STENDO CARE Already registered Register now Administrator Figure 1 general view of the STENDO CARE software user interface Page 14 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 While the STENDO software is running the operator may need to define certain parameters choose certain options or validate certain messages All of these operations are performed by the display of various windows To make the application easy to use we have defined a certain number of basic buttons that always have the same function and that are found in the various windows that can be displayed on the screen The Validate button is used to validate the input of a particular parameter the choice of a particular option and the appearance of a message on the screen
23. s document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 iaid Select the subject in the database and validate your choice by pressing o CONTRAINDICATIONS Having undergone major surgery in the year preceding the session Having undergone cosmetic surgery intervention in the year preceding the session Having a ban or restriction with a history of phlebitis or thrombosis Simultaneously taking oral contraceptive pill and smoking gt 10 cigarettes per day Open fracture bleeding or healing wound Presenting a medical contraindication to participating in sport Being pregnant Suffering from cancer Colostomy Suffering from hypertension Do any of these 3rd degree burns CONTRAINDICATIONS Cirrhosis of the liver apply to you Carefully read the contraindications to the subject and verify whether they apply to him her then answer the question by pressing either yes or no YES lf at least one of the contraindications apply to the subject press YES J STENDO CARE Consult your healthcare professional to obtain an authorization for a STENDO session Page 24 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3
24. software v3 0 3 1 iid 8 MAINTENANCE 8 1 Routine maintenance of the console Routine maintenance must be performed once a month in accordance with the following procedure e Turn the monitor power switch off and unplug from the mains supply e Clean the box the front and rear panels with a damp soft cloth using hot soapy water Use only a mild soap or detergent Allow to dry completely before use e Carefully inspect the power cables and connector to check there is no mechanical damage In case of damage proceed to replace the damaged component with an original STENDO replacement part Do not attempt to repair e Plug the power cable to the mains supply e Turn the monitor power switch off and then on again A N WARNING The monitor must be switched off and disconnected from the mains supply before cleaning The sockets and connectors must be kept scrupulously clean and dry Do not allow any liquid to enter the device Follow the instructions above to clean the monitor Do not use abrasive agents or chemical products not recommended in this manual 8 2 Routine maintenance of the suit Clean the internal lining of the suit with an antiseptic wipe after each use do not use any cytotoxic corrosive and allergenic cleaning products 8 3 Yearly maintenance The device must undergo yearly maintenance by a STENDO approved technician 8 4 Life expectancy The STENDO console has an estimated life expectancy of 10 years The pulsating suits ha
25. the subject to stop the session at any time by simply pressing the stop button Pressing the stop button switches off the power to the air distribution block and switches off the power to the multi parameter data card to prevent any unwanted blood pressure measurements This results in the appearance of the following screen Session aborted emergency stop activated Please indicate your level of satisfaction with IIIA IIAIR IIRA IRRA opinion JU UU Uo lt is now not possible to restart the session without manual intervention by the operator 5 6 2 Resuming after an emergency stop As previously indicated it will only be possible to continue to use the system after an emergency stop with the manual intervention of the operator Reset the console by pressing a button 13 of the console This step is imperative Page 28 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 0 5 7 Turning off the console X STENDO CARE Already registered Register now Administrator Quit If you want to turn off the console simply press X STENDO Exit STENDO application Register now Administrator Confirm that you want to exit and turn off the console by pressing Page 29 This document and its contents are the exclusive property
26. tral part 4 7 Pa s ype nn pS Waa Mapas Piat WS PS vp PT OST a pint War l AAT Se ae Sie A 8 ey AAEE fees a OL Ys a Ge Oy aM y Bae OAs DEANS Satine t ee A VEET I EANA 5 3 2 Attachment machine patient Once the subject is installed in the lower body suit provide the subject with the emergency stop control in their left hand Attach the finger pulse oximeter to one of the fingers of the right hand Attach 5 foam electrodes solid gel to the ECG leads LL LA RA RL and V Position the electrodes as follows Page 19 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 1 sii 5 4 Definition of a subject In order to start a session you first need to register the subject by clicking the icon register now This database allows the subject s data to be inputted before the session Part of these data are provided purely for information Some of these are compulsory others are optional On the screen press Register now The following windows appear on screen use the keyboard on screen to fill in the information and validate the information by pressing a surname of the subject feds st None onescecsesee cococococoooe p pa aw a w a w w a w w Shift lt Xa lala a qee enee aJalalulalulalwlalalalalen eqacec0cKec0rn0re Facecccanec
27. ts for pulsating suit single use non woven undergarment ECG patches 4 3 Operating conditions Temperature 15 C to 40 C Relative humidity 30 85 no condensation Room pressure 700 1060 hPa No corrosive gases in the atmosphere Supply voltage AC 100 240V 50 60 Hz Source of air that is clean free of oil and dust and dry with a minimum flow of 50 L min and providing pressure of between 3 and 6 bar 4 4 Transport and storage conditions Temperature 0 C to 60 C Relative humidity 30 95 no condensation Room pressure 500 1060 hPa No corrosive gases in the atmosphere This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO y STENDO STENDO V3 user manual software v3 0 3 1 ene 4 5 Installing the equipment Panel at front of console 5 5 4 1 2 3 1 NIBP cuff connector 2 ECG lead connector 5 electrodes 3 Finger pulse oximeter connector 4 Emergency stop wired control connector 5 Pulsating suit leg tube connectors Page 10 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO yp STENDO STENDO V3 user manual software v3 0 3 1 Panel at rear of console 6 Standard hospital air supply connector 7 6mm 4mm diameter compressed air source connector 8 RS232 connector 9 Female USB socket 10 Ethernet conne
28. uit to be adjusted in such a way that there is a slight space between the suit and the legs of the subject approximately the width of 2 fingers 1 Unfold the lower body suit internal lining facing upwards Page 16 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 one 2 Position the 2 internal edges of each leg vertically Adjust the rear ventral Velcro of the suit according to the girth of the patient 3 Place the subject on top of the suit in a supine position For improved adjustment ensure that the crotch of the lower body suit is as close as possible to the subject s groin Page 17 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO Q y STENDO STENDO V3 user manual software v3 0 3 1 ne 4 Fold over each leg of the suit onto the leg of the subject and fix at the level of the calves using the velcros 5 Fold over each leg of the suit onto the leg of the subject and fix at the level of the thighs using the velcros Page 18 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 ii 6 Adjust the ven
29. ve an estimated life expectancy of 1 year 8 5 Disposal of the device This symbol representing a bin garbage can on wheels with a bar across it means that this product is covered by the European directive 2002 96 EC The electrical and electronic components must be disposed of separately in bins trash cans specially intended for this purpose DO NOT INCINERATE THE DEVICE Page 37 This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO
30. water wipe the exterior and allow to dry completely before further use The electrical facilities of the premises or the equipment must comply with current regulations applicable in your country The equipment must be used in accordance with the user instructions provided by Stendo SAS Any changes or repairs must be performed by a member of staff approved by Stendo SAS or by approved technicians No modifications should be made to the device The STENDO system V3 must undergo yearly maintenance by a STENDO approved technician If the power cable power supply switch or fuse of the console needs to be changed it is imperative that it is replaced by an original component Risk of electric shock Do not remove the monitor cover This symbol representing a bin garbage can on wheels with a bar across it means that this product is covered by the European directive 2002 96 EC The electrical and electronic components must be disposed of separately in bins trash cans specially intended for this purpose Contacts Manufactured by Approved technicians STENDO SAS 17 Rue du port 2 400 Louviers France Tel 02 32 09 41 60 Fax 02 32 25 90 14 E mail address contact stendo net This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 enei 3 MEANING OF THE LOGOS PR
31. y taking an oral contraceptive pill and being a smoker more than 10 cigarettes per day e Suffering from hypertension e Presenting a medical contraindication to participating in sport e Suffering from cancer e Colostomy e Open fracture bleeding or healing wound e Third degree burn e Cirrhosis of the liver e Bedsore This system is not suitable for persons less than 16 years of age To date no significant side effects have been identified This document and its contents are the exclusive property of STENDO no use or reproduction is authorised without the prior written agreement of STENDO X STENDO STENDO V3 user manual software v3 0 3 1 iid Safe use Do not use the device in a hyperbaric environment Monitor functioning defect if a functioning defect occurs when the system is activated do not use the monitor until qualified maintenance staff have resolved the problem Position the leads attached to the patient in such a way as to avoid any risk of strangulation Do not reuse the ECG electrodes so as to avoid any risk of contamination or infection and also to avoid incorrect readings associated with improper adhesion to the skin Do not reuse or recycle the ECG electrodes since this is likely to result in incorrect readings or skin reactions due to biocompatibility problems Inthe even one of the device functions fails consult an approved maintenance technician If the device is accidentally exposed to
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