SysToe - PMS (Instruments)
Contents
1. NEW Go back to acquisition for a new measurement RET Go back to acquisition for a new examination FIND To load the name of the patient from the archives Then scroll the archives with the vertical arrows in order to find the proper name NEW Toe return to the acquisition screen to perform a new measurement RET To return to the main menu x Display the help screen about the Different fields of the patient file O Re initialization of the current patient file The default parameters are displayed Enter patient name with the alphanumeric pad x Change mode caps lock ABC abc gt 123 DEL Delete last character LOAD Load current patient last name RET Save and go back to patient file fg Aty s me User manual SYSTOE 14 168 Rev G Page 21 38 9 2 2 Birth date Birthdate Enter patient birth date DD MM YYYY 15 04 1952 with the numeric pad CDD MMANN A Selection of the figure that must be modified RET Save and go back to patient file 9 2 3 Sex Select Patient sex Select the patient sex with the Alphanumeric pad 1 MALE j P 2 FEMALE 3 Unge f RET Save and go back to patient file 9 3 Archive To review the saved measurements and select the Export mode From the main configuration menu select Archive 2 9 3 1 Display the archive list and open an archive This is the number of the archive ARCHIVE PY List scrolling up 0 4 UIEM _ List scrolling down2. RE Go back to previous menu MODE To display the export configuration screen Use the numeric pad The selected mode is marked with a star Export not needed once the internal memory is full 32 examinations the next examination that will be saved will erase automatically the archive n 1 and so on e _ Export needed once the memory is full no more examination can be recorded until examinations are deleted or exported to a PC A message will be displayed at the START of a new examination to let the user Know that the memory is full NB The SysToe archives can be deleted either from the PC clear flash or from the archive screen see 9 3 fg Aty s 9 5 9 5 1 9 5 2 9 5 3 9 5 4 User manual SYSTOE 14 168 Rev G Page 23 38 Exam parameters From the main configuration menu select Exam Parameters 4 Exam Parameters RET Go back to the main menu 1 Occlusion Pressure 2 Occlusion time S EmPtyingd time 4 TBI configuration RET Occlusion pressure Occlusion Pressure Input the value with the numeric pad Decl Pres 2D nits DEFLT Load default value 300 mmHg CLEAR Erase value RET Return to configuration menu DEFLT CLEAR RET Occlusion time This is the time the occlusion pressure is applied Occlusion time Input the value with the numeric pad Dec Time DEFLT Load default value 5s CLEAR Erase value RET Return to configuration menu DEFLT CLEAR R
3. Nun DEL Go back to previous menu DUMORA Charlotte Open an archive for re visualization a Yv RET see 9 3 2 z Delete current examination 0 0 Delete all examinations The SysToe can store up to 32 examinations The archive number is from 1 to 32 For each archive position the backup status is displayed e If no examination is saved at current archive position the label NONE is displayed e _ f an examination is saved at current archive position the name of the patient is displayed e f the current examination has been deleted o when the selected export mode is export not needed the examination is not fully deleted gt the label DELETED is displayed but the current examination cannot be replaced o when the selected export mode is export needed the examination is fully deleted gt the label NONE is displayed current archive location can be used User manual SYSTOE 14 168 Rev G Page 22 38 9 3 2 Review the content of an archive 9 4 When an archive is under re visualization all information specified in 8 7 and 8 8 can be reviewed but no new value can be input The following displays can be reviewed LIST To go back to the BACK To go back to the previous archive list screen NEXT To display the next NEW To go to the acguisition screen of the archive to perform a new measurement Configuration of the export mode From the main configuration menu select Export 3
4. 14 168 Rev G Page 37 38 Table 3 Manufacturer s Declaration Electromagnetic immunity The SysToe is suitable for use in the specified electromagnetic environment The customer and or user should assure that it is used in an electromagnetic environment as described below Immunity IEC Compliance Electromagnetic environment guidance Test 60601 level test level Conducted RF V1 3 Vrms Portable and mobile RF communications IEC 61000 4 6 equipment should be used no closer to any part of the SysToe including cables than the recommended separation distance Radiated RF calculated from the equation appropriate to IEC 61000 4 3 the frequency of the transmitter 3 V m Recommend separation distance 80 MHz an to 800 d Fa WP MHz 3 V m 800 MHz a P 80 MHz 800 MHz to 2 5 a GHz Ti d WP de 800 MHz 2 5 GHz E1 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 meters 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 o Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption
5. The product is designed produced and serviced in compliance with ISO13485 requirements Software development The software is compliant with IEC60601 1 2005 Usability The usability is maintained in compliance with IEC60601 1 6 Risk management The risk management is processed in compliance with ISO14971 Electro Magnetic Compatibility The SysToe has been designed to work normally in conditions specified by the international standard IEC60601 1 2 Essential performance for immunity tests A Criteria Start and stop image display image visible and allowing diagnosis B Criteria Image is affected but no diagnosis error is possible Information relative to the A class limitation The SysToe emits electromagnetic radiations These radiations do not allow the compliance to the B class in every configuration fg Atys Se medical User manual SYSTOE 14 168 Rev G Page 35 38 Table 1 Manufacturer s Declaration Electromagnetic Emissions IEC60601 1 2 The SysToe is suitable for use in the specified electromagnetic environment The customer and or user should assure that it is used in an electromagnetic environment as described below Compliance Electromagnetic Environment RF emission Group 1 The SysToe must emit electromagnetic energy CISPR 11 in order to perform its intended function Nearby electronic eguipment may be affected Emissions RF Class A The SysToe is suitable for use in all CISPR 11 establishments other than
6. cccecceseceeceeseeeeeeeeeeeeeeaaeeeeeeaaeeesesaaeeeseeaeeeens 13 8 2 OG CIS IO ae LE _ _ _ HA CN GP HYF YF 13 8 3 Double sided ring LANG iewistivcnccsoessssietecneriaacs ariesetsacesaunte NUN KAR AN a an 13 8 4 Sensor and its CAINE ossa deau Ln US OD DN 14 8 4 1 Normal 6 LYFR CCC RH FR CN CHY create sey mercer ee 14 8 4 2 OIL UO Uo yu DA YH cera Y Y ee ee ere 15 8 5 fai s iiL a ge c91 g gt 4 RFYFTEOEF DUFFRYN HN FFF Eaa 15 8 5 1 MODE selection of automatic or semi automatic mode 15 8 5 2 BRA P brachial pressure input cceeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeees 15 8 6 START start the MEASUEMENL cccccceeeeeeeeeeeceeeeeeeeeeeeaaaeeeeeeeeees 16 8 7 Display of the systolic pressure and TBI c ccceeeeeeeeeeeeeeeeeeeeeees 18 8 8 Input or the patient data eie eid oni O Gy GAWR AG 19 9 OT AI CIN UI ONE MN SU RY THCN FHS FR Y P 20 9 1 Maini Meni ARFFED e dein veadadia re ad RO NFETFN 20 9 2 PU UU tetera rates YF FYR TF CA AN AEF TF TEU Y NFYFC 20 9 2 1 I PN RNA ee eee 20 9 2 2 IL eM a cael pieced TF N E CREF R 21 9 2 3 SO en GG Y O YD YT ED 21 9 3 PAC TWE GG LUD DA 21 fa Aty S fa A User manual SYSTOE 14 168 Rev G Page 3 38 9 3 1 Display the archive list and open an archiVe 9 eeeeieeeu 21 9 3 2 Review the content of an arcChive ccccceceeeeeeeeeeeeeeeeeeeeaeeeeeees 22 9 4 Configuration of the
7. default value AR W CLEAR Erase value RET Return to configuration menu DEFLT CLEAR RET Device information Display device information like the unit serial number or the software version fg At 10 S medical User manual SYSTOE Error messages Exam memory full Memory full gt exPort Exam not saved il Be careful i No valid cursor Pos Adjust Pos manually or retry OS BGnety INSUFFICIENT DATA AVAILABLE PLEASE REDO 14 168 Rev G Page 25 38 If no sensor is detected when the user presses on START a message indicates that no examination can be performed RET Return to acquisition screen If 32 examinations have been recorded on the SysToe and if the selected export mode is export needed a message indicates to the user that the memory is full and that he she should export the examinations on the PC RET Return to acquisition screen If no position of the systolic pressure can be detected automatically a message indicates to the user that he she should manually adjust cursor position or retry the measurement RET Go to examination curve review The measurement process was stopped too early or signal level is not sufficient The measurement must be redone after verification of sensor and cuffs positioning fg Aty s 11 12 User manual SYSTOE 14 168 Rev G Page 26 38 Examination export via USB Connection between the SysToe and the PC
8. on VALID If it is not the case the user has to move the vertical cursor to its proper position with the horizontal arrows and then press on VALID Vertical cursor 9309 mort 15 Jr e an hits VALID a VALID VALID validation of the vertical cursor position and go to the result page Displacement of the vertical cursor Change the displacement speed for cursor scrolling Fast scrolling Zoom IN OUT fg Aty s 8 8 me User manual SYSTOE 14 168 Rev G Page 19 38 Once the user has validated the cursor position the following results screen is displayed EF TOE Toe or finger systolic pressure TOE BRR TBI BRA Brachial systolic pressure TBI Toe or finger Brachial Index 166 126 0 83 mmHA mnH BACK To go to the previous screen NEW Togo to the acquisition screen to perform a new measurement VALID To save the measurement in the internal memory x To input the brachial pressure BACK NEW VALID Input of the patient data Before saving the measurement in the internal memory of the SysToe it is advised to input some patient data in order to e Make easy the identification of the measurement e _ Take advantage of the report generator It is advised to input the patient name the type and the side of the digit toe or finger The VALID key on the results screen allows the saving of the measurement in the SysToe memory But before the three following screens are displayed one after the oth
9. sensor cuff The whole surface of the sensor must be well in contact with the toe The sensor must be placed on the back of the toe and not on the nail The sensor and its cuff must be positioned so that the sensor wire and the cuff tube go downwards as shown on the picture below Both cuffs must fit the toe but they must not be too tight They must not induce any residual pressure on the blood vessels User manual SYSTOE 14 168 Rev G Page 15 38 8 4 2 Short toe 8 5 8 5 1 The toe is too short to accommodate both cuffs The sensor cuff is not placed on the toe Remove the sensor from its cuff Stick a two sided adhesive on the sensor and stick the sensor on the toe Acquisition screen Once the SysToe is switched on the acquisition screen is displayed MODE Selection of AUTO normal toe or SEMI AUTO short toe BRA P Input of the brachial pressure only if TBI is needed START START the measurement x Access main menu MODE selection of automatic or semi automatic mode When the toe is long enough to accommodate both cuffs occlusion and sensor cuffs press on MODE to select MODE AUTO When the toe is too short to accommodate both cuffs remove the sensor from its cuff see 8 4 2 and press on MODE to select MODE SEMI AUTO Pn poe OO yne gui 8 5 2 BRA P brachial pressure input Input the value with the numeric pad The arm pressure is not measured by the SysToe DEFLT Load last programme
10. toes are cold it is advised to warm them up The skin temperature of the toe for low toes blood flow volume must be higher than 27 C The patient must remain relaxed throughout the exam The user should remind him her to remain still and refrain from talking Occlusion cuff Wrap the occlusion cuff at the base of the toe so that the pipe goes downwards For the big toe studies have shown that the width of the cuff must be at least 25 mm otherwise the measured pression is overestilated Double sided ring tape For a better contact of the sensor with the skin during the measurement stick a two sided ring adhesive on the sensor before positioning the sensor on the toe It is compulsory to stick the sensor otherwise the quality of the measurement is not warrantied The double sided tape has been designed by Atys especially for the Tongue of the protective layer 8 4 8 4 1 User manual SYSTOE 14 168 Rev G Page 14 38 Remove one double sided tape from its support pulling the tongue Apply the sticky part of the ring tape on the sensor Press firmly all over the ring to make sure it is well stuck on the sensor Remove the protective layer pulling the tongue off The adhesive ring must not cover the infrared cells Sensor and its cuff Then there are two cases according to the length of the toe Normal toe 8 4 1 and Short toe 8 4 2 Normal toe Stick the sensor on the extremity of the toe and fasten the
11. where it is not in compliance with IEC60601 1 the computer shall be placed outside the patient area leakage current must be verified for the whole system following IEC 60601 1 standard To be outside the patient area minimum distances of 1 5 m to the side 2 5 m above IEC countries or 1 83 m to the side and 2 29 m above UL countries are reguired 1 6 Sensor and cuffs Never use the sensor or the cuffs on skin surfaces with recent wounds operative cuts Never allow the transducer to come in contact with body fluid The sensor and cuffs must be disinfected between patients in order to prevent cross contamination Use all cleaning and disinfection procedures applicable to your institution A N The sensor and cuffs are fragile Be very careful during their use and cleaning medical User manual SYSTOE 14 168 Rev G Page 6 38 A A N N 1 8 CT tys 7 Electrical safety To avoid the risk of electrical shock do not remove the covers of the charger To avoid the risk of electrical shock contact a qualified service representative for service Before use control the sensor and its cable for visible damages Never use the sensor if cracks or other damages are visible Disconnection from the main supply disconnect the 2 poles simultaneously unplug the charger Do not position device so that it is difficult to disconnect from the mains In case of breakdown of the SysToe please conta
12. ET Emptying time This is the time the sensor cuff pressure is applied Emptuin9 time Input the value with the numeric pad The default value is 3 s EmPty Time DEFLT Load default value CLEAR Erase value RET Return to configuration menu DEFLT CLEAR RET TBI configuration TBI configuration 1 Display TBI index calculation 2 Do not display TBI index DisPlay TBI 2 T i i 2 TBI not needed RET Return to configuration menu The selected mode is marked with a star RET fg Aty s 9 6 9 6 1 9 6 2 9 6 3 9 6 4 9 6 5 User manual SYSTOE 14 168 Rev G Page 24 38 Device parameters From the main menu select Device parameters 5 DEVICE 1 Go to date and time adjustment aa 2 Go to language adjustment gef 3 Go to default user adjustment g nan ae 4 Go to the shut down time adjustment lser name 4 Shut down time Tr Device information RET Return to main menu Date and time Date Time Input the value with the numeric pad 1 Go to date adjustment 2 Go to time adjustment RET Return to configuration menu See 9 2 2 for explanations on how to input a date Language The current language is marked with a star User To input the user name Press on LOAD to load the last input user name Shut down time The SysToe is shut down if it is not used during X min X min is the shut down time Shut down time Input the value with the alphanumeric pad TM DEFLT Load
13. Export Mode ccceeeeeeeeeeeeeeeeaaeesseeeeeeeeeess 22 9 5 Exam AI Lc YFRYNFDD CO EE AF A YO FEN FEN A AEF NEF FA NAY 23 9 5 1 Occlusion pressure RF nee eer Cee NN HN 23 952 Qgcl si n WANS gest _ Y r REG 23 9 5 3 EMONI UMO Dd GA CADAU OS GEO NG YAA FA 23 9 5 4 TBEIcODmHGUIraHOll sioe Sian YG dU Eu NES R risaune NGENI NO SGAN OR 23 9 6 Device parameters FEN FFEFRYN FR FFA EN FF FEE HEFY TAF NF ANF 24 9 6 1 Date and IME NF AC Y0 G0 RCH PH PN FI AO FF HR 24 9 6 2 EUO cect etc PANN FYN FFYN FFAN CW DO FEN TENNYFNY FANON 24 9 6 3 ia i a FF FN WYN PDF ce FN FFA EN WHY EEF FN WYR HF HF 24 god RONMENT Sate oeu niw ninaa enpren Y ODAU DDN NO FAD 24 9 6 5 Device informiatiOll lt sc ui u isa Fai sb EAEA UO YRFA sada Un GWAU Un GAFN RCH OR 24 10 iie il 0c cist 2 051 PER nee ee rece ee YA ee 25 11 Examination export via USB 2 0 0 ccceecccccccseeeeeeeeeeeeeeaeeeeeeeeaeeseeeeesesaaasseeess 26 12 Powering off the device aea ai oa DG wd ar COG ER 26 BS AIT NF _ lt CNC RT RF Y EA FY YF REN FFR CR RE AY NW NW SF 27 13 1 SENSO A 60 eee eee TC een aas 27 13 2 GOLION Y A E EA EYES eee 27 14 DEVICE cece cence tes ra NER CN NY Y CCW NY eae ANDREW EN OREN DH 28 14 1 AU VS MlO5 COW gt ance ce eee o Ofn ee A De eee ee eee 28 14 2 Spare parts and accessori6S eeiiiin rrr YY LLYRY RHI I RH FF HN 28 14 3 Replacing the battery ccccceccccceeece
14. Keep press until SBE 91 mn H STOP When the pressure on the sensor must be released the SysToe emits a sequence of beeps Once the occlusion pressure is reached then the pressure in the occlusion cuff decreases slowly The display of the SysToe is the following ones w Ozama 1445 EO E SBE 15 45 EO The pressure in the occlusion cuff is The pressure in the occlusion cuff is higher than the systolic pressure lower than the systolic pressure fo y fg Aty s 8 7 iii User manual SYSTOE 14 168 Rev G Page 18 38 The examination automatically stops when the pressure reaches 10 mmHg But if the backflow is clear it is possible to stop the exam before The return of the blood flow takes place when the pressure in the cuff is lower than the systolic pressure This is shown on the SysToe by a clear and confirmed increase of the sensor signal DJBBnnHg 15 45 STOP Manual STOP of the examination procedure Use this function to stop the examination procedure before the occlusion cuff is fully deflated if you have noticed the backflow return or if you are under the impression that something is wrong o a Display of the systolic pressure and TBl Once the examination is over the following screen is displayed The SysToe places automatically the vertical cursor lt must be placed at the foot of the increase of the sensor signal as on the left hand display If it is the case the user has to press
15. Verify the unit integrity and the sensor cuff connections e Operate the following software assisted tests from the diagnostic module 14 4 1 Main menu Menu From the acquisition screen press on ES display the main menu MENU DIAGNOSTIC l 1 Battery Teme Patient File 2 Photo Detector Archive 3 Qcclusion Leakage Export 4 Sensor Leakage Exam Parameters AsDewice config DIAG NEM RET P Pressure Calib RET Press on DIAG to display the diagnostic menu 14 4 2 Control of the battery charge and temperature Diagnostic Battery VB Current battery level VBatt gt 450mV at end of charge cn O Tp Internal device temperature in C lt 60 C Ch Actual charge level DC adaptor not connected RET Return to diagnostic main menu NOT CHARGING 14 4 3 Control of the sensor photo detector Press on INFO Apply the sensor on a digit Press on RESET The electrical signal value is displayed The result of the test is displayed e Test passed e Test failed Signal 550 300 lt signal lt 700 RET Return to diagnostic main menu Nest passeg fa Aty S ir r User manual SYSTOE 14 168 Rev G Page 31 38 14 4 4 Control of the occlusion cuff leakage Install the occlusion cuff on a tube of 10 20mm diameter Press on START The device will inflate the occlusion cuff and test for leakage during 15s The final leakage value is displayed The result of the test is displayed as test p
16. Windows is allowed in order to down load the measurements stored into the SysToe to a PC The software delivered with the SysToe must be installed on the PC When connecting the USB cable the SysToe directly goes to this menu ExPort 1 Export current examination to the PC 2 Export all examinations to the PC J pxbort current exam r won mw i a 2 Export ALL exams MODE Go to export mode configuration RET _ Go to main menu MODE RET ExPort If the user select adjust Time Date on a Er t SysToe from the PC the following screen 1 ExPort current exam MWY 2 ExPort ALL exams is displayed MODE Go to export mode configuration RET Go to main menu MODE ExPort If the user select erase all exams on the PC a message is displayed on the SysToe a cen ghey LAE to allow the user to validate or not the a S a complete deletion WIN Erase FLASH YES Erase all exams YES NO NO Do NOT erase all exams Powering off the device The SysToe be switched from any screen To switch off the SysToe press the power ON OFF key for a few seconds until the power off menu is displayed SYSTOE POWER OFF Sete e Uae YES To confirm the switch off NO _ To cancel the switch off Do not Plug charger Here it is advised not to plug the SysToe to the charger CT tys 13 13 1 N N N 13 2 medical User manual SYSTOE 14 168 Rev G Page 27 38 Cleaning Sensor and cuff As the cuffs and the sen
17. age 10 38 6 7 Safety Symbols ROHS Do not wasp To be partially recover and re used USB input output signal IEC60417 5333 Sensor protection type is BF IEC60417 5031 DC charger input IEC60417 5109 Do not use in a private home environment ISO7000 1641 Consult operating instructions CE MARK IEC60417 5134 Electrostatic sensitive connector ISO7000 2498 Serial number IEC60417 5448 Data Input and Output IEC60417 5546 Battery load indicator ISO7000 434 Consult accompanying documents IEC60417 5009 standby B Bet gt U 9 gl i G 6 8 Device labels RESET Halts the system in case of emergency Can damage the system do not use to stop the system MENU Accesstomenu o gt oO oOo O O ZOOM Zoom curves after acquisition s e pressure in the toe or finger Toe or Finger brachial index Toe or Finger systolic pressure brachial systolic pressure or SENSOR Air flow connector to sensor cuff 0o Cl 6 9 medi User manual SYSTOE 14 168 Rev G Page 11 38 Layout and displayed symbols GHI JKL MNO 6 PORS TUV WXYZ Function Keys F1 F2 F3 Power ON OFF Battery power indicator Occlusion pressure Slow scrolling Fast scrolling fg Atys Se medical User manual SYSTOE 14 168 Rev G Page 12 38 Management of the battery Replace the battery pack annually or when its capacity is noticeably diminished The battery has been design
18. 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 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 SysToe is used exceeds the applicable RF compliance level above the SysToe should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SysToe b Over the frequency range 150 kHz to 80MHz field strengths should be less than 3 V m fg Atys Se medical User manual SYSTOE 14 168 Rev G Page 38 38 Table 4 Recommended separation distance between portable and mobile RF communications eguipment and the SysToe The SysToe is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SysToe can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications eguipment transmitters and the SysToe as recommended below according to the maximum output power of the communications eguipment Rated Maximum Separation distance according to freguency of transmitter in Ou
19. assed or test failed Occlusion Curr Pres 305mmHg Pres 290mmHg Pres l5mmHg passed Os 15s 14 4 5 Control of the sensor cuff leakage Install the sensor cuff on a tube of 10 20mm diameter as above Press on START The device will inflate the sensor cuff and test for leakage during 15s The final leakage value is displayed The result of the test is displayed as test passed or test failed Sensor Cuff Pres 305mmHg Pres 290mmHg Pres 15mmHg passed OFS 15e RES 14 4 6 Control of the pressure sensor calibration The control of the pressure sensor calibration can be performed by any qualified technician It is advised to perform this control once a year The calibration of the pressure sensor must be performed by Atys Reguired eguipment sphygmomanometer that must be calibrated by an accredited laboratory The battery of the SysToe must be charged The following message should not be displayed A Be careful Battery too low gt Use Sustoe loader RET Connect a sphygnomanometer on the occlusion cuff output User manual SYSTOE 14 168 Rev G Page 32 38 n Control of zero pressure oora a Press 252mmHg Press on RAZ The value on the manometer should be 0 mmHg Control of the 100 mmHg pressure With the bladder of the sohygnomanometer input a pressure equal to 100 mmHg on the manometer Read the value displayed on the SysToe The SysToe passes the test when
20. ct your Atys dealer Environmental protection Do not wasp the SysToe and its accessories They can be partially recovered and re used The wasting of the package and the SysToe must be performed according the national regulations Intended use The SysToe is designed to measure the toe or the digit systolic pressure in a non invasively way in order to assess peripheral vascular disease The SysToe must be used in hospitals physician office or medical facilities Principle of operation Introduction The SysToe inflates the occlusion cuff up to the preset occlusion pressure Then it deflates the occlusion cuff slowly until the pressure in the cuff reaches 10 mmHg The pressure in the cuff and the PPG Photo PlethysmoGraphy signal are recorded during deflation The pressure at the time of resumption of arterial inflow is the systolic pressure Resumption of arterial inflow is detected by the PPG sensor fg Atys 3 2 medical User manual SYSTOE 14 168 Rev G Page 7 38 Photo plethysmography PPG sensor The PPG sensor is composed of an emitter and a photodetector Infrared The interaction of light with biological tissue is complex and includes the optical processes of multiple scattering absorption reflection transmission and fluorescence Light received by the photodetector is affected by the blood volume blood vessel wall movement and the orientation of red blood cells RBC The pulsatile component of th
21. ctro Magnetic Compatibility ccccccccecceccsseeeeeeeeeeeeeeeeeeeeeeeaas 34 fg Atys Se medical User manual SYSTOE 14 168 Rev G Page 4 38 1 Read first 1 1 Operator The SysToe performs properly only when operated and maintained as specified in this manual It is the responsibility of the operator to use the SysToe in accordance with the user s manual the warnings and the labels For transport and storage the device must be placed in its original packing Cautions to be applied for the transport and the storage are labeled on the box Storage 10 40 C 10 80 Hr If you do not have the original packing materials please contact your AN Atys dealer Do not use the SysToe if the packing is damaged 1 3 Operating environment Climatic environment Do not use the device outside the specified environment To prevent fire and electrical hazards keep the SysToe out of rain water and humidity If the system does come in contact with liquid shut the system down and contact your Atys service representative Operating 15 25 C 10 80 Hr Power supply Universal medical grade AC DC converter class Il 9Vdc A N Use only the power supply supplied by Atys Electro magnetic compatibility EMC For best product performance and measurement accuracy use only accessories supplied by Atys Use accessories according to the N manufacturer s directions for use and your facility s standards The use of acces
22. d value CLEAR Erase value RET Save amp return to the acquisition screen fg i Atys Se medical User manual SYSTOE 14 168 Rev G Page 16 38 8 6 START start the measurement From the acquisition screen press on START to start an examination e If current mode is AUTO regular toe cuffs are automatically inflated once the user has pressed on START e f current mode is SEMI AUTO short toe the user needs to press on the sensor to start the examination The pressure on the sensor should be kept as long as the message Keep press until bip is displayed see hereafter description table with illustrations The user needs to ress rather hard to get a proper emptying of the toe pulp Toe length mode positioning Sensor cuff YES NO Sensor YES with double sidedtape YES with double sided tape positioning Before START a Before START Whatever the mode AUTO or SEMI AUTO the display of the SysToe looks like one of these two displays OS BGnety 15 43 OZAAnmHa 1542 EO MODE AUTO MODE AUTO U MODE BRA P START MODE BRA P START fg Aty s Me User manual SYSTOE 14 168 Rev G Page 17 38 START Press on START to start the measurement After START AUTOMATIC PUMPING Press quite strongly on the sensor as shown below to start the inflation of the OS BEng MODE SEMI AUTO gt Press to start STOP Keep pressing on the sensor until the following message is no longer displayed
23. e PPG waveform AC component has its fundamental frequency depending on heart rate This AC component is superimposed onto a large quasi continuous component DC component that relates to the tissues and to the average blood volume This DC component varies slowly due to respiration vasomotor activity and vasoconstrictor waves Traube Hering Mayer THM waves and thermoregulation Main features The SysToe is a portable lightweight instrument which measures the systolic pressure in the digit in a non invasive way The principal features of the SysToe are the followings e Automatic inflation and deflation the cuffs e Display the PPG sensor signal and the systolic pressure SYS in the toe or digit e Display the TBI Toe Brachial Index or Finger Brachial Index once the user inputs the systolic brachial pressure e Can store up to 32 examinations Enables data to be transmitted to a computer via the USB port for their storage and the printout of examination reports Infrared sensor Applied parts Infrared sensor faint 6 2 6 3 a by User manual SYSTOE 14 168 Rev G Page 8 38 Component set up Unpacking Atys ships the system in a box specially designed for the SysToe It is essential to ship the equipment using the original packing materials Main components Confirm all components below are present If any component is missing or damaged contact Atys or its representative Box including t
24. ed for a certain number of charge discharge cycles The battery must be charged only when a specific message is displayed Hereafter is an example of this kind of messages I Be careful an Battery too low gt Use Systoe loader RET When the SysToe is switched off or on a message is displayed in order to let you know if you have to connect the charger or not If the battery is low and if you have to do a measurement you can work with the SysToe connected to the charger Once the SysToe is connected to the charger it must remain connected to the charger for 5 hours in order to charge fully the battery To charge the battery plug the charger to the charger connector on the side of the SysToe The yellow CHARGING indicator flashes during charging The SysToe uses a Nickel Medal Hydride NiMH battery pack The system charges a fully depleted battery in 5 hours Do not always use the SysToe connected to the charger fg Atys 8 2 8 3 medical User manual SYSTOE 14 168 Rev G Page 13 38 A measurement step by step Patient preparation Position the patient appropriately on his her back on the examination table You may elevate the patient s head the head only not the back with pillows for greater comfort The patient s feet should be resting comfortably on the examination table For accurate exam results the patient must be warm The room temperature should be between 22 C and 25 C If the patient s
25. eeeeeeeeeeeeeeesseeeeeeeeseeseeeeeeseeeaees 29 14 4 FROUDISSMOOUIAG ie ee Y We Y NY FC YY MOR SATAN DYNNU NAF YO 30 14 4 1 Main NENU 55 cass csnacessasesdoansaessc5esenaia a EFR EATE 30 14 4 2 Control of the battery charge and temperature 30 14 4 3 Control of the sensor photo detector ccccccseeeeeeeeeeeeeeees 30 14 4 4 Control of the occlusion Cuff lEaKag6 9veeeeeeeieiiiiinn 31 14 4 5 Control of the sensor cuff leakage 0 cceeeeeeeeeeeeeeeeeeeeeeees 31 14 4 6 Control of the pressure sensor Calibration 31 14 4 7 C DIAU Flo E OY O Ud O SDO NF CE CO ODD DAU 32 i Es MM 1 NOUNS EWYRTH RHYN HF YH NF NE EF HEFY FY HE FER CYFF NF 33 10 4 Chile id TL Gy e ANAN OFF 33 16 1 Electrical characteriSliCS ee een dnn Gi RY Y Y FR RR 33 16 2 Physical specifications sieri iie ne dio Nyd 0 nee ddi O NS NG dn Yd Radd OG 33 16 3 Pressure SENSO FF s FRAN iiaei 33 16 4 PPU SENO aea GN gee dae end sas SO aes 33 17 Standard comp ll aT eiii CR Ry Sf Aw Y MO FN 34 17 1 NS DY Y E _ w OK IN RD 34 17 2 Quality MaAMAG SIN a EF NY 34 17 3 Software development cccccccccceccceeeeeseeeeeeeeeeeeeeeseeeaaaecseeeeeeeeeees 34 17 4 i sr Ii R Y AFU ARY YNOF AFFAIRS ass FD YN ANT FFY FFYN 34 17 5 Risk management Gw Oia SG NAD CAG lw Ae 34 17 6 Ele
26. ental protection scssssecnssventccnseesiecnesvsstcceseesedndenentcineededneaeestetans 6 2 Mendo US Eea E I YF MDF FA HR 6 3 PCIE TIONS ONO 9 NG FFRYNT HN A FREE RT CAF FY FA NHY 6 3 1 Ta ce ye Le i i a EDDU RG RF RR PH FU T3 RH PR OF FF AA PENAU 6 3 2 Photo plethysmography PPG sensor ssceeeeeeeeeeeeeeeeeeeeeeeeeees 7 4 NNT AUIS cgro eea DYNO SG CAS CORD UO 7 5 fi a 9 116 o 72 Li eget RY E acl MR AN aioe eran set I E YH YN INT 7 6 Component Set Up sccstansactesacenaressnassctetenstoreansiases GRY GDG ANO NER 8 6 1 MTEC UIC ANF FEWR FD AF RNA RF ET T 8 6 2 LE Lee 4 9 ye 1 i sssri T 8 6 3 Preparation TON USG ec citteoniohsitecndnetiocen S OO 8 6 4 IAS ANC ERDF FYNN AFF RATFTFRYFN NF NF EFFEANE ATEFFFR FR HRAFE HEFFE 9 6 5 TUDNO SO FWYN RN FFY FR E YF FYRFYFYR FFF FYNU FFAN FN YY 9 6 6 OU GW cen ee ee ee ete Y RP 9 6 6 1 Sensor CUl ance nn oe ee nena anna enna eee eee nn Y 9 G02 OCUS CUI WN RH eee E R tem ret eee 9 6 7 LIS he 14 119 16 S WE HN NIR Y NHY 10 6 8 DEVICE IAD GIS TT AIAAI HE YRR FFR RNA REA ENER 10 6 9 Layout and displayed symbols ccccceeeeeeeeeeeeeeeeeeeeeeeeeeesaaeneeeees 11 7 Management of the battery ccccceeeeceecceeeeeseeeeeeeeeeeseeeeeeeeeaaeeeeeeeeesaeees 12 8 A measurement step by step cccccccseeeeeeeeeeeeeeeeeeeeeeeeaeaseeeeeeeseaaseeeenesees 13 8 1 Patient Preparation
27. er to give the opportunity to the user to input some specific data about the patient When there is a figure or a symbol in front of a line of a menu it means that if you press on the alphanumeric pad on the same figure or symbol you will adjust or display the corresponding field TOE configuration BACK Togo to the previous display Tue NEW To go to the acquisition screen in cd oe order to perform a new Ck Num Om ooo um ND 12345 VALID To validate the input data BACK VALID Patient File Exam Parameters Exam date Exam time Bir thin Pume mode 4 Sex Exam num BACK NEW VALID BACK NEW SAVE SAVE To save the current measurement and go to the acquisition screen in order toperform a new measurement fg Aty s User manual SYSTOE 14 168 Rev G Page 20 38 9 Configuration menus When there is a figure or a symbol in front of a line of a menu it means that if you press on the alphanumeric pad on the same figure or symbol you will adjust or display the corresponding field 9 1 Main menu Menu From the acquisition screen press on to go to the main configuration menu Yr 2 4 5 MENU confi 9 2 Patient File Patient 1 Last o i To input the File Name 2 F1rst Name Birthdate 4 Sex FIND 9 2 1 Name Last Name gt gt DUMORA 4 Cars DEL NEW Lock LOAD patient data RET DIAG DIAGNOSTIC see Erreur Source du renvoi introuvable
28. fg tys medical User manual SYSTOE 14 168 Rev G Page 0 1 14168 G _ SysToe user s manual wedi a Dm 8 03670 LLEN May 15 2009 Upgrade 03 887 February 10 2010 Update for Canada regulation Atys medical gt Atys Photos updates Include of mode SEMI AUTO 03 915 April 1st 2010 Additional pictures for small toe examination 04 090 E 7 02 2011 Publication date is added CE mark is added Page number corrected 04 321 27 01 2012 CEM tables 04 335 28 08 2012 Software version 23a APPROBATION e MU MD fg Atys medica User manual SYSTOE 14 168 Rev G Page 1 38 SysToe User s manual April 27 2012 14 168 Rev G Atys SARL 17 parc d Arbora 69510 Soucieu en Jarrest France Tel 33 4 78 05 69 69 Fax 33 4 78 05 69 60 atys atysmedical com fa Aty S fa A User manual SYSTOE 14 168 Rev G Page 2 38 Contents 1 PAGE MIN St EFFRO NO NEN CHAR EU YA A E E FNAN EYAF CN 4 1 1 ODO O FF HT eee ee ee eee NHY YF 4 1 2 Storage GDVIrODfnT amp TllJ is 41 a 4kn443x 3 R A ARNA YNAAGAN 4 RNGNA NWR ANNA ANSAR GARA RONA NON OA ARNA ARWR 4 1 3 Operating envirOniTielllassc cecsisceueeai4unEae AC UDG AGRO NUN RONA R UR ORA AARON ARR Ra DAR 4 1 4 Maintenance and service ccccccccneeeeeeeeeceeeeeeeeeeeeeeaeaeeeeeeseesaaseeeees 5 1 5 Safety requirements for PC USB connection eeeeeeeeeeiieeeeeeeoo 5 1 6 1 4 or and CUS PF FFA Y RF DF NR YF FT HAN 5 1 7 eee Gal OLY e E A 6 1 8 Environm
29. he PC software ac amp the user s manual box USB cable Battery for PC connection charger PPG sensor cuff with sensor Occlusion cuff Main unit Tubing set for the two cuffs Preparation for use The device is shipped ready for use All the elements the cuffs and the sensor are connected to the SysToe To use the PC software you will have to connect the USB cable For packing or moving of the device you can place the device with the connected sensor and cuffs in the packing box fg 6 4 6 5 6 6 6 6 1 6 6 2 ees iy User manual SYSTOE 14 168 Rev G Page 9 38 Side panel Sensor Buzzer USB l Occlusion cuff SENSOR OCCL Pressure sensor Emergency stop Battery charging indicator Flashing when charging Charger connector RESET To stop the system in case of emergency Could damage the system do not use to stop the system Tubing set The tubing set is composed of 2 linked tubes that make the connection between the cuffs and the SysToe and one half tube for the sensor cable Cuffs SysToe side Toe side Sensor cuff The sensor cuff includes a tube that is fitted with a female connector This female connector is connected through the tubing set to the device Occlusion cuff The occlusion cuff includes a tube that is fitted with a male connector This male connector is connected through the tubing set to the device g t sn i User manual SYSTOE 14 168 Rev G P
30. ip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5Y UT 95 dip in UT for 5 sec 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 5b Y UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5bY UT 95 dip in UT for 5 sec Floor 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 and or hospital environment Mains power quality should be that of a typical commercial and or hospital environment Mains power quality should be that of a typical commercial and or hospital environment If the user of the SysToe requires continued operation during power mains interruption it is recommended that the SysToe powered from an uninterruptible power supply or battery It may be necessary to position the SysToe further from the sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low Note UT is the AC mains voltage prior to application of the test level Table 38 Electromagnetic Immunity IEC60601 1 2 Aty S rasta User manual SYSTOE
31. regularly for visible cracks and leaks If such damage is found do not use the cuffs and the sensor 14 2 Spare parts and accessories Reference Description 14 112 SysToe module 14 133 SysToe occlusion cuff set 25 mm X 120 mm 14 525 SysToe occlusion cuff set 15 mm X 90 mm FOR 2 or 3 TOE 14 154 SysToe carrying box 14 504 SysToe Software to transfer the data to a PC under Windows 16 954 Charger Atys power supply universal input 9Vdc 8W 15 393 Cuff for sensor 18 844 Sensor User manual SYSTOE 14 168 Rev G Page 29 38 Battery pack SysToe Double sided ring tape 14 3 Replacing the battery Must be performed by a qualified service technician Tool required screwdriver To replace the battery use a PZ head screwdriver to remove the four battery compartment screws Unplug the old battery Plug in the new battery and close the battery door Tighten the screw firmly but do not over tighten CAUTION The battery pack contains a temperature measurement component that is matched to the cell type and to the product requirements Use only replacement battery packs as specified by Atys medical CAUTION Unauthorized battery substitutions will void the warranty and may cause overheating CAUTION Used NiMH batteries must be recycled or disposed of properly Do not incinerate e e y User manual SYSTOE 14 168 Rev G Page 30 38 14 4 Troubleshooting In case of trouble and at least once a year e
32. residential Harmonic emissions Class A It can be used in residential establishment with IEC 61000 3 2 the respect of the following advising Voltage fluctuations flicker Complies Advising This device is designated to be used emission exclusively by professional medicine people IEC 61000 3 3 The SysToe can provide radio electrical perturbations or can affect the operation of nearby electronic equipment It could be necessary to use reduction measures like reorienting displacing installation in other place or shielding place loi S Ab gor User manual SYSTOE 14 168 Rev G Page 36 38 Table 2 Manufacturer s Declaration Electromagnetic Immunity IEC60601 1 2 The SysToe is suitable for use in the specified electromagnetic environment The customer and or user should assure that it is used in an electromagnetic environment as described below Immunity Test Test Level Compliance Electromagnetic IEC 60601 1 2 Level Environment Guidance 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 IEC 61000 4 11 Power freguency 50 60 Hz magnetic field IEC 61000 4 8 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 5Y UT gt 95 dip in UT for 0 5 cycle 40 UT 60 d
33. sor come in contact only with intact skin the risk of infection is low so the cuffs and the sensor need only to be cleaned and low level disinfected between patients Use only hospital approved cleaning agents for USA FDA cleared to clean the cuffs and the sensor after each use and wipe dry immediately Be very careful for the cleaning of the cuffs and the sensor They must be handled carefully Never bend or pull the cable Never place it over open wounds or allow them to come in contact with body fluid Do not use the following methods for sterilization and disinfection They would induce damages on the cuffs and the sensor Sterilization e Autoclave and Ultrasound Disinfection e Chlorine at 100 e Glutaraldehide at 100 e Hydrogen peroxyde at 100 e lodine at 100 Console Always turn off the system and disconnect it from the power outlet before cleaning the machine Otherwise electric chock may result Do not place fluid on or near the system Clean the external surface casing with soft cloth soaked with alcohol Make sure that the cloth is damp but not saturated as you should avoid introducing fluids into areas of electrical components Allow the unit to dry before returning it to operation fg Atys Se medical User manual SYSTOE 14 168 Rev G Page 28 38 14 Service 14 1 After sales service To obtain additional information contact your Atys representative AN Inspect the cuffs and the sensor
34. sories sensors and cables other than those specified may result in increased emission and or decreased immunity of the SysToe AN The SysToe shall not be used in home environment Nys User manual SYSTOE 14 168 Rev G Page 5 38 1 4 Maintenance and service The SysToe performs properly only when operated and maintained as specified in this manual It is the responsibility of the operator to use the SysToe in accordance with the user s manual the warnings and the labels If the SysToe is found defective it should not be used The SysToe should not be used if any parts are missing or are damaged Parts that are visibly broken worn out warped or contaminated must be replaced No components should be replaced with parts from any other manufacturer If the customer suspects a part may be defective it is the customer s responsibility to contact Atys or Atys representative The SysToe should only be repaired by technicians authorized by Atys No components should be replaced with parts from any other manufacturer If the customer suspects a part may be defective it is the customer s responsibility to contact Atys or Atys representative The SysToe should only be repaired by technicians authorized by Atys A N No modification of this equipment is allowed 1 5 Safety requirements for PC USB connection Commercial associated computer shall be in compliance with IEC60601 1 or with the standards applicable to the PC In the case
35. the displayed pressure on the SysToe is equal to 100 mmHg 3 mmHg If the SysToe fails the tests it should be calibrated by Atys 14 4 7 Calibration The following calibrations can be performed e Calibration of the pressure sensor e Calibration of the deflation of the occlusion cuff The calibration must be performed by Atys CT tys 15 16 16 1 16 2 16 3 16 4 medical User manual SYSTOE 14 168 Rev G Page 33 38 Regulations EC Class lla device Canada Class 2 device Technical data Electrical characteristics Internally powered equipment with a NiMH battery Type 18 522 Systoe battery pack 2500mAh Replacement interval 1 year Charge time 5h Discharge time standby 3h Discharge time operating 150 examination cycles Physical specifications Dimensions 15 cm x 10 cm height 5 5 cm Weight 0 5 kg Pressure sensor Measurement and display range 0 330 mmHg Accuracy 3 above 70mmHg and 2mmHg below 70mmHg PPG Sensor Infrared type sensor CT tys 17 17 1 17 2 17 3 17 4 17 5 17 6 medical User manual SYSTOE 14 168 Rev G Page 34 38 Standard compliance Safety SysToe is compliant with IEC60601 1 international code of safety Safety Class Type internally power appliance when operating or class ll when battery in charge Applied parts BF type Mechanical protection index IP20 SysToe is compliant with CE and Canada regulations Quality management
36. tput Power of meter Transmitter in watt 150 kHz a 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the eguation applicable to the freguency 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 80MHz and 800MHz 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 Table 5 Maximum Length USB Cable 2
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