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DYSIS Ultra 2.0 Digital Colposcope Instructions for Use  
0230-53095, Rev 05 
Revision Date 05-Mar-2021 

 

 

Page 

76

 of 

79

 

 

31.

 

Appendix 2: 60601-1-2 DATA 

Tables of guidance and manufacturer’s declaration regarding electromagnetic emissions and immunity as per EN 

60601-1-2:2015. Data extracted from Eurofins York EMC Test Report 5109TC2. 

EN60601-1-2: 2015 

Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: 
Electromagnetic disturbances 

–

 Requirements and tests 

For Professional Healthcare Facility Environment 

Reference Standard 

Levels 

Result 

Emissions 

Conducted RF emission 

EN55011:2009+ A1:2010 

Referenced in Table 2 (Page 26) 

Class A 

Mode 1 

Mode 2 

Pass 

Radiated RF emission (Enclosure) 

EN55011:2009+ A1:2010 

Referenced in Table 2 (Page 26) 

Class A 

Mode 1 

Mode 2 

Pass 

Harmonic Distortion 

EN61000-3-2+A1:2009+A2:2009 

Referenced in Table 2 (Page 26) and section 7.2.1 

A 

Mode 1 

Pass 

Voltage Fluctuations and Flicker 

EN61000-3-3: 2013 

Referenced in Table 2 (Page 26) and section 7.2.2 

Plt 

Pst 

Dmax 

Mode 1 

Pass 

Immunity 

Enclosure Port (Table 4 

–

 Page 34) 

Electrostatic Discharge 

EN61000-4-2: 2009 

Referenced in Table 4 (Page 34) 

2, 4, 8, 15kV air 

2, 4, 6, 8kV contact 

Mode 1 

Pass 

Radiated RF EM fields 

EN61000-4-3: 2006+A1:2008+ IS1:2009+A2: 2010 

Referenced in Table 4 (Page 34) 

3V/m 

80-2700MHz 

Mode 1 

Pass 

Proximity fields from RF wireless communications equipment 

EN61000-4-3: 2006+A1:2008+ IS1:2009+A2: 2010 

Referenced in Table 9 (Page 40) 

As detailed below and in section 8.10 
of standard 

Mode 1 

Pass 

 
 

 

Содержание Ultra 2.0

Страница 1: ...DYSIS Ultra 2 0 Digital Colposcope Instructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 DYSIS Ultra 2 0 Digital Colposcope Instructions for Use...

Страница 2: ...Off the DYSIS Ultra 2 0 Digital Colposcope 19 15 Overview Operating DYSIS Ultra 2 0 Digital Colposcope 19 16 DYSIS Acetic Acid Applicator Kit 20 17 Positioning for an examination 20 18 DYSIS Ultra 2...

Страница 3: ...6 9 Periodic Cleaning and Maintenance 55 26 10 Routine Electrical Testing 55 26 11 Connecting an external monitor 55 26 12 Troubleshooting 56 26 12 1 Troubleshooting guide 56 26 12 2 Software messages...

Страница 4: ...the compliance standards and guidelines for the DYSIS Ultra 2 0 Digital Colposcope DYSIS Medical operates a Quality Management System which complies with the requirements of ISO 13485 2016 The CE mar...

Страница 5: ...cedure in general These have to be evaluated and determined by the healthcare provider and may include the patient s ability to tolerate a standard speculum examination conditions that may be best tre...

Страница 6: ...s by users thoroughly trained in the appropriate medical procedures DYSIS intended operator Education Minimum Knowledge A physician or a medical professional that is trained in and qualified to perfor...

Страница 7: ...while it is being moved Stepping and sitting on the device is prohibited Before using the DYSIS Ultra 2 0 Digital Colposcope make sure that it is in optimal use condition Do not spill any liquids on...

Страница 8: ...rnal data storage media have been checked for malware viruses trojans etc before connecting to DYSIS Ultra 2 0 Digital Colposcope Do not spray solutions or liquids into air vents Do not immerse any pa...

Страница 9: ...hat there is 15ml 10 exams left in the container While the DYSISmap measurement is in progress do not obscure the light beam or the camera While the DYSISmap measurement is in progress patient movemen...

Страница 10: ...SIS Ultra 2 0 Digital Colposcope LED emission Class 2 LED product warning 4 2 Location of Labels The product label containing the device name serial number DYSIS Ultra 2 0 Digital Colposcope legal man...

Страница 11: ...Date 05 Mar 2021 Page 11 of 79 Product Label containing the device name serial number DYSIS Ultra 2 0 Digital Colposcope legal manufacturer address Unique Device Identifier Barcode Safety Label conta...

Страница 12: ...he software DYSIS Ultra 2 0 Digital Colposcope is a Risk Group 2 LED product according to IEC 62471 The DYSIS reusable metal speculum is a Type BF applied part and the DYSIS disposable speculum is a T...

Страница 13: ...riately trained DYSIS Medical personnel carry out assembly test operations extensions readjustments modifications or repairs The electrical installation of the room complies with the electrical requir...

Страница 14: ...be disengaged To disengage the brake push down the green pedal with your foot When in a suitable position the red switch on the pedal should be pressed to engage the brake Do not use your hands to en...

Страница 15: ...is close to other objects 8 3 Clinician Monitor The clinician monitor is a touchscreen monitor It is used during the colposcopic examination to perform the procedure see Section 19 for DYSIS Examinat...

Страница 16: ...hen in examination mode 8 4 2 DYSIS Acetic Acid Applicator An automatic spraying system for acetic acid application is integrated into the optical head See Section 25 8 for changing the DYSIS Acetic A...

Страница 17: ...central processing unit CPU line up the notches and insert Rotate the cord 45 degrees to the right until it locks into place There will be an audible click as the yellow tab moves into the locked pos...

Страница 18: ...can be immediately converted to a treatment speculum by the attachment of a sterile disposable Treatment Pipe The latter is a small plastic tube that is mechanically clipped to the diagnostic speculu...

Страница 19: ...IS Ultra 2 0 Digital Colposcope with DYSISmap is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification The DYSISmap feature is an adjunctive to...

Страница 20: ...anded in detail in the following sections 18 5 21 15 DYSIS Acetic Acid Applicator Kit The DYSIS Acetic acid applicator assembly is filled by removing the bottle from its holder unscrewing the lid and...

Страница 21: ...oscope Software Application 17 1 Logging In After turning DYSIS Ultra 2 0 Digital Colposcope on the user must LOGIN to access the application The application displays a keyboard on the touchscreen and...

Страница 22: ...selecting the corresponding button As well as the home menu other options are available by selecting the icon on the upper left corner which expands a side panel with additional functions From this ex...

Страница 23: ...separate menu is available from the button when in examination mode see section 18 6 Will close the menu and or software in use 17 4 Creating a New Patient Record To create a record for a new patient...

Страница 24: ...DYSIS Ultra 2 0 Digital Colposcope Instructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 Page 24 of 79 All information will be saved to the patient record on pressing SAVE...

Страница 25: ...g down the list which is alphabetical by LAST NAME Alternatively the database can be searched by entering information into the boxes above the columns of data or by touching the column heading which w...

Страница 26: ...xamination Preparation and Functions 18 1 Adding data to a Patient visit record After the New Patient record is saved and again after the colposcopic examination is completed the user can enter additi...

Страница 27: ...ditional patient information 18 2 Using DYSIS to perform examination of the Lower Genital Tract without mapping To use DYSIS Ultra 2 0 Digital Colposcope to carry out examination of the Lower Genital...

Страница 28: ...he right hand side menu of the DYSIS Exam screen by using the buttons or by moving the OPTICAL HEAD closer to or further away from the subject Additional functions are offered through the right hand s...

Страница 29: ...0 Digital Colposcope Instructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 Page 29 of 79 In order to exit and save the images videos press the button from the upper left corner and select o...

Страница 30: ...er can start an examination by selecting DYSIS EXAM from the home menu without entering patient information or after initiating a new visit of a specific patient see section 17 5 or by creating a NEW...

Страница 31: ...ly DYSIS Ultra 2 0 Digital Colposcope can be connected to the speculum via the speculum coupling adapter at the front of the optical head after insertion to stabilise the image during the examination...

Страница 32: ...ances the contrast of the image To deactivate press the button again Green Filter Displays the green filtered light of the colour image To deactivate press the button again Brightness Control Allows t...

Страница 33: ...e DYSIS Exam Mode additional options are available from prior to and during the examination Examination Screen with left side menu shown Shows Saved images Displays images that were taken and saved Ca...

Страница 34: ...option then select the area on the touchscreen Biopsy Markers Add or remove biopsy markers during the examination and after the map review Start Starts the DYSIS mapping Prior to starting the DYSIS ex...

Страница 35: ...an be taken and saved High resolution still images can be saved by selecting the camera button a dialog box with an image preview and a keyboard on the touch screen prompt the user to enter a comment...

Страница 36: ...r can review the images that have been captured thus far by clicking on the playback icon The playback can be accessed by clicking on the button at the bottom of the screen in live viewing A set of co...

Страница 37: ...er to review response to the acetic acid 20 Using DYSIS Ultra 2 0 Digital Colposcope IN TRIAL mode When using DYSIS Ultra 2 0 Digital Colposcope in TRIAL Mode the user will follow the steps as above S...

Страница 38: ...his step has not been completed On displaying the map preselected biopsy points are shown in bright blue colour The Colposcopist would then mark any additional areas of interest highlighted by the map...

Страница 39: ...DYSIS Ultra 2 0 Digital Colposcope Instructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 Page 39 of 79...

Страница 40: ...user has examined the patient and has selected biopsy sites if applicable based on standard practice guidelines Additional biopsy sites may be selected after viewing the colour coded map but viewing...

Страница 41: ...convenient location where the vertical axis represents the acetowhitening intensity and the horizontal axis represents the time since application of acetic acid Examination Screen DYSISmap graph show...

Страница 42: ...erlaid on the displayed image and do not follow the movements of the cervix Therefore they should be used with caution if the cervix moves after marking The biopsy markers are live and when the image...

Страница 43: ...LPOSCOPY Additional colposcopic findings can be documented after the examination The COLPOSCOPY screen will be automatically displayed after the live image screen is exited MANAGEMENT PLAN Management...

Страница 44: ...tructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 Page 44 of 79 HISTOLOGY RESULTS Enter per point histology results for biopsies taken NOTES Area for additional information which can be ty...

Страница 45: ...atically captured during examination Will allow the user to freehand draw on the DYSIS Ultra 2 0 Digital Colposcope touchscreen Allows the user to view and customise the visit report Exports the entir...

Страница 46: ...ns This storage capacity will vary according to length of videos number of maps generated etc 22 1 Reviewing a visit To access the database from the HOME MENU press PATIENT DATABASE Patient names will...

Страница 47: ...n be searched more specifically by completing any of these boxes Highlighting the patient in the database list will display their list of visits in the right hand summary of the patient record OPEN in...

Страница 48: ...mages when a map is available By pressing it the colour distribution of the map will be presented 22 2 Visit History The DYSIS patient records can be amended after a visit at any time and those change...

Страница 49: ...SIT HISTORY section of the patient record 22 3 SMARTtrack SMARTtrack allows the user to compare different visits which occurred on separate occasions together allowing longitudinal tracking of patient...

Страница 50: ...age in order to align the second image when magnifying to get a better view of a specific area of interest The buttons below each image allow images to be advanced individually frame by frame taken at...

Страница 51: ...For example a map which shows a reduction in a strong aceto white response and a reduction in red yellow and white will show a negative value below the centre line illustrating the amount of reduction...

Страница 52: ...abase to a remote server SCREEN LOCKOUT and other functions of the DYSIS Ultra 2 0 Digital Colposcope Access to the settings functions are via an Administrator password only which can be set by your D...

Страница 53: ...t immerse any part of DYSIS Ultra 2 0 Digital Colposcope into cleaning solutions When not in use the DYSIS Ultra 2 0 Digital Colposcope should be stored with lower arm folded against itself utilising...

Страница 54: ...stened with isopropyl alcohol or lens cleaner Pay special attention not to scratch the surface during cleaning IMPORTANT NOTE DO NOT USE CIRCULAR MOTION WHEN WIPING THE WINDOW USE ONLY STRAIGHT MOVEME...

Страница 55: ...by filling the reservoir with the high level disinfection liquid and then draw and press the syringe plunger to fill the tubing repeat until the tubing is filled and liquid is sprayed from the nozzle...

Страница 56: ...sure you shut down the instrument disconnect from mains power and restart the unit before contacting technical support If any of the suggested actions fail to solve the problem please contact the DYS...

Страница 57: ...ch is OFF and reconnect the main power cable to the power brick the power cable is locked into the DYSIS Ultra 2 0 Digital Colposcope base Turn the main power switch ON Outlet has no electricity Ensur...

Страница 58: ...ectory is valid and accessible Failed to Export Report Please Configure an Export Path in Settings Please check through an administrator account that the export directory is valid and accessible It ha...

Страница 59: ...check the USB memory stick that is working properly and plug it again Ensure the USB drive is formatted as ex FAT if this message is prompted again please use another USB memory stick Unable to Connec...

Страница 60: ...Browser to access the Printer Configuration WebPage http Go to the displayed webpage on a pc laptop to access the printer configuration page in order to add a printer or clear queue 25 13 Replacing t...

Страница 61: ...Such products are marked with the crossed out wheelie bin WEEE symbol shown right in accordance with European Standard EN50419 Decommissioning aims to make devices safe and unusable while minimising...

Страница 62: ...introduce a significant risk to the patient s well being as it can be repeated at a later time The progression of cervical disease is rather slow so a few hours or days of delay do not introduce a ri...

Страница 63: ...1 x Ethernet port Monitor 15 touchscreen monitor Full HD 1920x1080P pixels max resolution 60Hz Optical Head Unit CMOS sensor Resolution 2800 x 2100 pixels 21 frames per second able to differentiate 2...

Страница 64: ...wnload data This should only be configured by a DYSIS representative please ask your DYSIS representative for information on this function This tab is only available to administrators FOR SITES THAT A...

Страница 65: ...Setting EXPORT of cases to an external server and also IMPORT VISIT from another DYSIS In addition the user can carry out CALIBRATION export LOG FILES for routine maintenance or to assist with remote...

Страница 66: ...which is encrypted and only readable from DYSIS software not in a patient folder format iv Password and User tabs The PASSWORD function allows restricted and unrestricted users to manage their own pa...

Страница 67: ...ng new users a default password is applied The new user is prompted to change password on their first log in v Export Using ADMIN access log in the EXPORT tab allows the user to add a printer add a lo...

Страница 68: ...0 Digital Colposcope http www openprinting org printers If compatible then proceed with the following steps or follow the instructions found on the above link Press the Add new printer button By pres...

Страница 69: ...95 Rev 05 Revision Date 05 Mar 2021 Page 69 of 79 Go to the Administration tab as shown below and press Add Printer under the Printers section The following screen will appear For a network printer se...

Страница 70: ...ress of the network printer along with its shared name see example below and then press Continue On the following screen add a name and then press Continue The following screen by selecting the printe...

Страница 71: ...DYSIS Ultra 2 0 Digital Colposcope Instructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 Page 71 of 79 When instructed just select default options...

Страница 72: ...he Printers tab the printer will be displayed On the dropdown menu where Maintenance is listed please select Print test page to verify that the printer was successfully installed Now the installed pri...

Страница 73: ...SCOPE Storage Enabled AE Title DYSIS_PACS Address IP Address the IP address of the PACS server Port 11112 The Click Check Connection To make sure everything works After this after a New Exam has been...

Страница 74: ...en through on the patient database a new button named Todays appointments will appear By pressing it only the today s appointment will be listed In order to switch between the entire patient database...

Страница 75: ...DYSIS Ultra 2 0 Digital Colposcope Instructions for Use 0230 53095 Rev 05 Revision Date 05 Mar 2021 Page 75 of 79...

Страница 76: ...d in Table 2 Page 26 Class A Mode 1 Mode 2 Pass Radiated RF emission Enclosure EN55011 2009 A1 2010 Referenced in Table 2 Page 26 Class A Mode 1 Mode 2 Pass Harmonic Distortion EN61000 3 2 A1 2009 A2...

Страница 77: ...ulse Modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation 18Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1...

Страница 78: ...795 MHz 13 553MHz to 13 567MHz 26 957MHz to 27 283MHz and 40 66MHz to 40 70MHz Mode 1 Voltage Dips and Interrupts 0 UT 0 5 cycle Pass EN 61000 4 11 2004 Referenced in Table 5 Page 35 at 0 45 90 135 18...

Страница 79: ...arge EN61000 4 2 2009 Referenced in Table 8 Page 39 2 4 8 15kV air 2 4 6 8kV contact Mode 1 Pass Electrical Fast Transients Bursts EN61000 4 4 2012 Referenced in Table 8 Page 39 1kV 100kHz repetition...

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