ATYS MEDICAL SysToe User Manual Download Page 35

Page: 35 / 39

User manual

– SYSTOE

14 168

Rev. G

Page 34/38

Standard compliance

17.1 Safety

SysToe

is compliant with IEC60601-1 international code of safety.

Safety Class:
Type internally power appliance when operating or class II when battery in
charge.
Applied parts: BF type.
Mechanical protection index: IP20.

SysToe

is compliant with CE and Canada regulations.

17.2 Quality management

The product is designed produced and serviced in compliance with
ISO13485 requirements.

17.3 Software development

The software is compliant with IEC60601-1:2005

17.4 Usability

The usability is maintained in compliance with IEC60601-1-6

17.5 Risk management

The risk management is processed in compliance with ISO14971

17.6 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.

Summary of Contents for SysToe

Page 1: ...ebruary 10th 2010 Update for Canada regulation Atys medical Atys Photos updates Include of mode SEMI AUTO 03 915 D 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 F 27 01 2012 CEM tables 04 335 G 28 08 2012 Software version 23a APPROBATION Quality R D Atys Sales ...

Page 2: ...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 ...

Page 3: ...el 9 6 5 Tubing set 9 6 6 Cuffs 9 6 6 1 Sensor cuff 9 6 6 2 Occlusion cuff 9 6 7 Safety Symbols 10 6 8 Device labels 10 6 9 Layout and displayed symbols 11 7 Management of the battery 12 8 A measurement step by step 13 8 1 Patient preparation 13 8 2 Occlusion cuff 13 8 3 Double sided ring tape 13 8 4 Sensor and its cuff 14 8 4 1 Normal toe 14 8 4 2 Short toe 15 8 5 Acquisition screen 15 8 5 1 MODE...

Page 4: ...2 Console 27 14 Service 28 14 1 After sales service 28 14 2 Spare parts and accessories 28 14 3 Replacing the battery 29 14 4 Troubleshooting 30 14 4 1 Main menu 30 14 4 2 Control of the battery charge and temperature 30 14 4 3 Control of the sensor photo detector 30 14 4 4 Control of the occlusion cuff leakage 31 14 4 5 Control of the sensor cuff leakage 31 14 4 6 Control of the pressure sensor c...

Page 5: ...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 I...

Page 6: ...onsibility to contact Atys or Atys representative The SysToe should only be repaired by technicians authorized by Atys 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 where it is not in compliance with IEC60601 1 the computer shall ...

Page 7: ...Toe 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 2 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 3 ...

Page 8: ... 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 4 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 f...

Page 9: ...tys or its representative 6 3 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 Box including the PC software the user s manual Battery charger er...

Page 10: ...le 6 6 Cuffs SysToe side Toe side 6 6 1 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 6 6 2 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 OCCL OCCL SENSOR SENSOR Occlusion cuff Buz...

Page 11: ...nnector ISO7000 2498 Serial number IEC60417 5448 Data Input and Output IEC60417 5546 Battery load indicator ISO7000 434 Consult accompanying documents IEC60417 5009 standby 6 8 Device labels RESET Halts the system in case of emergency Can damage the system do not use to stop the system MENU Access to menu ZOOM Zoom curves after acquisition SYS Systolic pressure in the toe or finger TBI Toe or Fing...

Page 12: ...User manual SYSTOE 14 168 Rev G Page 11 38 6 9 Layout and displayed symbols Battery power indicator Occlusion pressure Slow scrolling Fast scrolling Power ON OFF Function Keys F1 F2 F3 ...

Page 13: ...der 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...

Page 14: ... 27 C The patient must remain relaxed throughout the exam The user should remind him her to remain still and refrain from talking 8 2 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 8 3 Double sided ring tape For a bette...

Page 15: ...ff 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 The adhe...

Page 16: ...of the brachial pressure only if TBI is needed START START the measurement Access main menu 8 5 1 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...

Page 17: ...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 press rather hard to get a proper emptying of the toe pulp Toe length REGULAR TOE SHORT TOE Examination mode AUTO see 8 3 SEMI AUTO see 8 4 2 Occlusion cuff positioning YES YES Sensor cuff positioning YES NO Remove the cuff Sensor positioning YES with ...

Page 18: ... the following message is no longer displayed Keep press until BIP 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 The pressure in the occlusion cuff is higher than the systolic pressure The pressure in the occlusion c...

Page 19: ...iced the backflow return or if you are under the impression that something is wrong 8 7 Display of the systolic pressure and TBI Once the examination is over the following screen is displayed The SysToe places automatically the vertical cursor It 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 on VALID If it is not...

Page 20: ...ke 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 other to give the opportunity to the user to input some specific data about the patient When there is a figure or...

Page 21: ...k to acquisition for a new examination 9 2 Patient File To input the patient data 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 Display the help screen about the Different fields of the patient file 0 Re ini...

Page 22: ...Open an archive for re visualization see 9 3 2 0 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 If no examination is saved at current archive position the label NONE is displayed If an examination is saved at current archive position the name of the patient...

Page 23: ... main configuration menu select Export 3 RET 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 Export needed once the memory is full no more examination can be...

Page 24: ... the time the occlusion pressure is applied Input the value with the numeric pad DEFLT Load default value 5s CLEAR Erase value RET Return to configuration menu 9 5 3 Emptying time This is the time the sensor cuff pressure is applied Input the value with the numeric pad The default value is 3 s DEFLT Load default value CLEAR Erase value RET Return to configuration menu 9 5 4 TBI configuration 1 Dis...

Page 25: ...Go to time adjustment RET Return to configuration menu See 9 2 2 for explanations on how to input a date 9 6 2 Language The current language is marked with a star 9 6 3 User To input the user name Press on LOAD to load the last input user name 9 6 4 Shut down time The SysToe is shut down if it is not used during X min X min is the shut down time Input the value with the alphanumeric pad DEFLT Load...

Page 26: ...sage 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 ...

Page 27: ...ion RET Go to main menu If the user select adjust Time Date on SysToe from the PC the following screen is displayed MODE Go to export mode configuration RET Go to main menu If the user select erase all exams on the PC a message is displayed on the SysToe to allow the user to validate or not the complete deletion YES Erase all exams NO Do NOT erase all exams 12 Powering off the device The SysToe be...

Page 28: ...pen 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 Autoclave and Ultrasound Disinfection Chlorine at 100 Glutaraldehide at 100 Hydrogen peroxyde at 100 Iodine at 100 13 2 Console Always turn off the system and disconnect it from the power outlet before cl...

Page 29: ...amage 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 2nd or 3rd 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 Cu...

Page 30: ...lug 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 o...

Page 31: ...ol of the battery charge and temperature Diagnostic Battery VB 385 Tp 25 Ch 80 DC adaptor not connected NOT CHARGING RET VB Current battery level VBatt 450mV at end of charge Tp Internal device temperature in C 60 C Ch Actual charge level RET Return to diagnostic main menu 14 4 3 Control of the sensor photo detector Press on INFO Apply the sensor on a digit Press on RESET The electrical signal val...

Page 32: ...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 Initial Pres 305mmHg Final Pres 290mmHg Falling Pres 15mmHg Test passed Chrono 0s 15s START RET 14 4 6 Control of the pressure sensor calibration The control of the pressure sensor calibration can be performed by ...

Page 33: ...ut a pressure equal to 100 mmHg on the manometer Read the value displayed on the SysToe The SysToe passes the test when 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 Calibration of the pressure sensor Calibration of the deflation of the occlusion cuff The ...

Page 34: ...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 16 2 Physical specifications Dimensions 15 cm x 10 cm height 5 5 cm Weight 0 5 kg 16 3 Pressure sensor Measurement and display range 0 330 mmHg Accuracy 3 above 70mmHg and 2mmHg below 70mmHg 16 4 PPG Sensor Infrared type sensor ...

Page 35: ...is compliant with IEC60601 1 2005 17 4 Usability The usability is maintained in compliance with IEC60601 1 6 17 5 Risk management The risk management is processed in compliance with ISO14971 17 6 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 an...

Page 36: ...function Nearby electronic equipment may be affected Emissions RF CISPR 11 Class A The SysToe is suitable for use in all establishments other than residential It can be used in residential establishment with the respect of the following advising Advising This device is designated to be used exclusively by professional medicine people The SysToe can provide radio electrical perturbations or can aff...

Page 37: ...n mode Mains power quality should be that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply IEC 61000 4 11 5 U T 95 dip in UT for 0 5 cycle 40 U T 60 dip in UT for 5 cycles 70 U T 30 dip in UT for 25 cycles 5 U T 95 dip in UT for 5 sec 5 U T 95 dip in UT for 0 5 cycle 40 U T 60 dip in UT for 5 cycles 70 U T 30 dip in UT for ...

Page 38: ...s from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorpti...

Page 39: ...t Separation distance according to frequency of transmitter in meter 150 kHz à 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitt...

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