Table of Contents
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14168 G
Modif.
Rév.
03 600
A
03 670
B
03 887
C
03 915
D
04 090
E
04 321
F
04 335
G
APPROBATION
Quality
User manual – SYSTOE
SysToe, user's manual
Date
March 2, 2009
th
May 15
, 2009
th
February, 10
2010
April, 1st 2010
7/02/2011
27/01/2012
28/08/2012
R&D Atys
14 168
Initial release
Upgrade
Update for Canada regulation
Atys medical > Atys
Photos updates
Include of mode SEMI-AUTO
Additional pictures for small toe
examination
Publication date is added
CE mark is added
Page number corrected
CEM tables
Software version 23a
Sales
Rev. G
Page 0/1
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Table of Contents
Summary of Contents for ATYS MEDICAL SysToe
- Page 1 User manual – SYSTOE 14 168 Rev. G Page 0/1 SysToe, user’s manual 14168 G Modif. Rév. Date 03 600 March 2, 2009 Initial release 03 670 May 15 , 2009 Upgrade 03 887 February, 10 2010 Update for Canada regulation Atys medical >...
- Page 2 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...
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Page 3: Table Of Contents
User manual – SYSTOE 14 168 Rev. G Page 2/38 Contents Read first ...................... 4 Operator ..................... 4 Storage environment ................4 Operating environment ................ 4 Maintenance and service ..............5 Safety requirements for PC-USB connection ........5 Sensor and cuffs ................. 5 Electrical safety ................... - Page 4 User manual – SYSTOE 14 168 Rev. G Page 3/38 9.3.1 Display the archive list and open an archive ......... 21 9.3.2 Review the content of an archive ..........22 Configuration of the export mode ............22 Exam parameters ................23 9.5.1...
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Page 5: Read First
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. The SysToe must be used by or on the order of physician. -
Page 6: 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. -
Page 7: Electrical Safety
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. -
Page 8: Photo Plethysmography (Ppg) Sensor
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: ... -
Page 9: Component Set-Up
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. -
Page 10: Side Panel
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 OCCL. -
Page 11: Safety Symbols
User manual – SYSTOE 14 168 Rev. G Page 10/38 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... -
Page 12: Layout And Displayed Symbols
User manual – SYSTOE 14 168 Rev. G Page 11/38 Layout and displayed symbols Function Keys Power F1/F2/F3 ON/OFF Battery power indicator Occlusion pressure Slow scrolling Fast scrolling... -
Page 13: Management Of The Battery
The battery must be charged only when a specific message is displayed. Hereafter is an example of this kind of messages. 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. -
Page 14: Measurement Step By Step
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 SysToe. It must be supplied only by Atys. Support Tongue of the... -
Page 15: Sensor And Its Cuff
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... -
Page 16: Short 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... -
Page 17: Start: Start The Measurement
Occlusion cuff positioning Sensor cuff positioning (Remove the cuff) Sensor YES, with double-sided tape YES, with double-sided tape positioning Before START Before START Whatever the mode (AUTO or SEMI-AUTO), the display of the SysToe looks like one of these two displays. - Page 18 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 The pressure in the occlusion cuff is...
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Page 19: Display Of The Systolic Pressure And Tbi
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. -
Page 20: Input Of The Patient Data
To input the brachial pressure 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: Make easy the identification of the measurement ... -
Page 21: Configuration Menus
User manual – SYSTOE 14 168 Rev. G Page 20/38 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. -
Page 22: Birth Date
(see §9.3.2) 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”... -
Page 23: Review The Content Of An Archive
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) -
Page 24: Exam Parameters
User manual – SYSTOE 14 168 Rev. G Page 23/38 Exam parameters From the main configuration menu, select “Exam Parameters” (4). RET.: Go back to the main menu 9.5.1 Occlusion pressure Input the value with the numeric pad. DEFLT: Load default value (300 mmHg) CLEAR: Erase value RET.:... -
Page 25: Device Parameters
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. -
Page 26: Error Messages
User manual – SYSTOE 14 168 Rev. G Page 25/38 Error messages 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... -
Page 27: Examination Export Via Usb
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. YES: To confirm the switch off... -
Page 28: Cleaning
User manual – SYSTOE 14 168 Rev. G Page 27/38 Cleaning 13.1 Sensor and cuff As the cuffs and the sensor 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. -
Page 29: Service
SysToe occlusion cuff set 14 525 15 mm X 90 mm FOR 2 or 3 SysToe carrying box 14 154 SysToe Software to transfer the 14 504 data to a PC under Windows 16 954 Charger Atys power supply, universal... -
Page 30: Replacing The Battery
User manual – SYSTOE 14 168 Rev. G Page 29/38 Battery pack SysToe 14 140 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. -
Page 31: Troubleshooting
User manual – SYSTOE 14 168 Rev. G Page 30/38 14.4 Troubleshooting In case of trouble and at least once a year, Verify the unit integrity and the sensor/cuff connections Operate the following software assisted tests from the diagnostic module. -
Page 32: Control Of The Occlusion Cuff Leakage
The calibration of the pressure sensor must be performed by Atys. Required equipment: sphygmomanometer that must be calibrated by an accredited laboratory. The battery of the SysToe must be charged. The following message should not be displayed. Connect a sphygnomanometer on the occlusion cuff output. -
Page 33: Calibration
With the bladder of the sphygnomanometer, input 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. -
Page 34: Regulations
Canada: Class 2 device Technical data 16.1 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. -
Page 35: Standard Compliance
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. - Page 36 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. Emission Test...
- Page 37 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...
- Page 38 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.
- Page 39 Recommended separation distance between portable and mobile RF communications equipment 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...
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