DYSIS Ultra 2.0 Digital Colposcope Instructions for Use · DYSIS Ultra 2.0 Digital Colposcope Instructions for Use – (US) 0330-53095 R1 Page 7 of 77 Use only cabling supplied or

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use – (US) 0330-53095 R1

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use


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CONTENTS 1. Applicable Standards ......................................................................................................... 4 2. General Description ........................................................................................................... 5 3. Indications for Use ............................................................................................................. 5 4. Optimal Use of the Pseudo-Color Imaging (PCI) feature ................................................... 5 5. Summary of Warnings and Cautions ................................................................................. 6 5.1. Location of Labels ............................................................................................................ 11 6. Classifications .................................................................................................................. 12 7. Environmental Conditions ............................................................................................... 13 7.1. Storage ............................................................................................................................ 13 7.2. Usage ............................................................................................................................... 13 7.3. Transportation ................................................................................................................. 13 7.4. Atmospheric Pressure ..................................................................................................... 13 8. Usage Restrictions ........................................................................................................... 13 9. Components of DYSIS Ultra ............................................................................................. 14 9.1. BASE / Moving the Instrument ........................................................................................ 14 9.2. ARMS ............................................................................................................................... 14 9.3. Clinician Monitor ............................................................................................................. 15 9.4. Imaging head ................................................................................................................... 15 9.4.1. Camera and Light ............................................................................................................. 15 9.4.2. DYSIS Acetic Acid Applicator............................................................................................ 16 9.4.3. Speculum Connector ....................................................................................................... 16 10. Power cord and Power On/Off ........................................................................................ 16 11. Assembling and inserting the power cord ....................................................................... 16 12. Accessories ...................................................................................................................... 17 13. Powering on DYSIS Ultra .................................................................................................. 18 14. Powering Off DYSIS Ultra ................................................................................................. 18 15. Overview – Operating DYSIS Ultra ................................................................................... 18 16. DYSIS Acetic Acid Applicator Kit ...................................................................................... 19 17. Positioning for an examination ....................................................................................... 19 18. DYSIS Ultra Software Application .................................................................................... 20 18.1. Logging In ........................................................................................................................ 20 18.2. Home Menu ..................................................................................................................... 20 18.3. General navigation buttons ............................................................................................. 21 18.4. Calibration of the System ................................................................................................ 22 18.5. Creating a New Patient Record ....................................................................................... 24 18.6. New Visit for an Existing Patient ..................................................................................... 25 19. DYSIS Examination Preparation and Functions ............................................................... 27 19.1. Adding data to a Patient visit record ............................................................................... 27 19.2. Using DYSIS to perform an examination of the Lower Genital Tract without mapping .. 28 19.3. Assigning a visit after a DYSIS Exam from the Home screen ........................................... 29 19.4. Using DYSIS to perform a standard colposcopic examination ......................................... 30 19.5. Preparing the patient ...................................................................................................... 30 19.6. Additional Options ........................................................................................................... 32 20. Starting the DYSIS Exam .................................................................................................. 33 20.1. The DYSIS Map ................................................................................................................. 38 20.2. Dynamic curves ............................................................................................................... 39 20.3. Adding additional biopsy markers ................................................................................... 40 20.4. Biopsy point viewing ....................................................................................................... 40 20.5. Exiting the Exam .............................................................................................................. 41 21. Additional information post colposcopic examination ................................................... 41 22. Patient Database ............................................................................................................. 45 22.1. Reviewing a visit .............................................................................................................. 45 22.2. Visit History ..................................................................................................................... 48


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22.3. SMARTtrack ..................................................................................................................... 49 23. Downloading or Printing a Report ................................................................................... 51 24. Additional Functions ....................................................................................................... 52 24.1. Info .................................................................................................................................. 52 24.2. Password tab ................................................................................................................... 52 25. Care, Maintenance and Troubleshooting ........................................................................ 52 25.1. General ............................................................................................................................ 52 25.2. Replacement of Parts ...................................................................................................... 53 25.3. ARM, BASE and Computer Housing Cleaning .................................................................. 53 25.4. Touchscreen Monitor Cleaning ....................................................................................... 53 25.5. Imaging head Cleaning .................................................................................................... 53 25.6. Disinfection ..................................................................................................................... 54 25.7. DYSIS Specula .................................................................................................................. 54 25.8. DYSIS Acetic Acid Applicator ........................................................................................... 55 25.9. Periodic Cleaning and Maintenance................................................................................ 55 25.10. Routine Electrical Testing ................................................................................................ 55 25.11. Troubleshooting .............................................................................................................. 55 25.11.1. Troubleshooting guide .................................................................................................... 56 25.11.2. Software messages.......................................................................................................... 57 25.12. Replacing the DYSIS Acetic Acid Applicator..................................................................... 60 26. Warranty, Service, Expected Service Life and Recycling ................................................. 60 26.1. WEEE Regulations ........................................................................................................... 60 27. Contact Information ........................................................................................................ 60 28. Technical Description ...................................................................................................... 61 Appendix 1: ADMINISTRATOR SETTINGS ....................................................................................... 62 i. Connectivity .................................................................................................................... 62 ii. System ............................................................................................................................. 63 iii. Password and User tabs .................................................................................................. 63 iv. Export .............................................................................................................................. 65 a. Adding a printer .............................................................................................................. 65 v. EMR ................................................................................................................................. 70 a. DICOM Storage ................................................................................................................ 71 b. Modality worklist ............................................................................................................ 71 c. HL7 (adding appointments & patient demographics retrieval) ...................................... 72 Appendix 2: 60601-1-2 DATA ........................................................................................................ 74


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1. Applicable Standards Refer to Declaration of Conformity for a list of the standards and guidelines the DYSIS digital colposcope complies with. DYSIS Medical operates a Quality Management System which complies with the requirements of ISO 13485: 2012 The CE mark on this product indicates it has been tested to and conforms to the provisions noted in the 93/42/EEC European Medical Device Directive.

USA Patent No 7749162 FDA 510(k) Clearance letter K092433


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2. General Description Thank you for purchasing the DYSIS Ultra Colposcope, manufactured by DYSIS Medical. Please read this guide carefully before using your equipment. DYSIS has been designed to maximize safety and minimize strain for users and patients. However, precautions must be taken to further reduce risk of personal injury or damage to the device. Be careful to follow the general precautions in this User Guide and note the cautions included. To maintain your DYSIS in good working condition, please follow the operation and maintenance procedures described here-in. DYSIS Ultra is a digital image colposcope designed to assist Clinicians in the in vivo evaluation, documentation and follow up of cervical pathology. DYSIS is meant to be used in hospitals and clinics by users who are trained in the relevant medical procedures. The DYSIS intended operator is a medical professional trained in the examination of the cervix, vagina and vulva. No particular technical expertise is required to operate the DYSIS Ultra system.

3. Indications for Use DYSIS with Pseudo-Color Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to confirm normalcy or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening on the cervix. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. Please read the following operating and maintenance instructions thoroughly before using your new digital colposcope. Following these instructions can help to ensure many years of reliable service. IMPORTANT: The material outlined in this manual should be reviewed and understood prior to operation of the equipment. IMPORTANT: The user of this equipment should be thoroughly trained in the medical procedures appropriate to the instrumentation. Furthermore, time should be taken to read and understand these instructions before performing any procedures. Instructions for other equipment used in conjunction with DYSIS with Pseudo-Color Imaging (PCI) (i.e. electrosurgical generators) should also be read and understood. Failure to do so may result in injury to the patient and/or damage to DYSIS with Pseudo-Color Imaging (PCI).

4. Optimal Use of the Pseudo-Color Imaging (PCI) feature When using the PCI feature, please ensure biopsies have adequate surface area to account for possible image registration error in the pseudo-color overlay map. During the Dynamic Imaging procedure, which is used to generate a pseudo-color map, it is important to instruct the patient to remain as still as possible, otherwise the system will not be able to generate a map. DYSIS is intended to be used in hospitals and clinics by users thoroughly trained in the appropriate medical procedures.

DYSIS intended operator Education/ Minimum Knowledge:

A physician or a medical professional who is trained in, and qualified to perform, colposcopic procedures

Language Understanding:


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English Minimum Experience:

Experience in the colposcopic procedures Permissible Impairments:

As applied in regular colposcopic practice

5. Summary of Warnings and Cautions

When using this system, always conduct a thorough colposcopy examination, identifying and selecting areas for biopsy, before using the PCI feature to (possibly) select additional biopsy sites. The DYSIS with PCI has not been shown to identify areas of cervical neoplasia. Therefore, never use this system to omit a biopsy selected on the basis of the conventional colposcopy examination.

Users of this equipment should be thoroughly trained in the appropriate medical procedures and must read this guide carefully before operating this device. Failure to do so may result in injury to the patient and/or damage to the device.

The following list summarizes the warning, caution and information messages found in this guide.

(This Warning Symbol Applies to the Safety Warnings Below) Users of this equipment should be thoroughly trained in the appropriate medical procedures and must read this guide carefully before operating this device. Failure to do so may result in injury to the patient and/or damage to the device. No modification of this equipment is allowed. Do not use DYSIS if it appears to be damaged or broken. The power cable must always be positioned so as to minimize risk for tripping. Do not tilt, push, pull, or move DYSIS in ways other than that described in this manual for its proper/optimal and safe use. Stepping and sitting on the device is prohibited. Before using DYSIS, make sure it is in optimal condition for use, as presented at installation. Do not spill any liquids on the device.


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Use only cabling supplied or approved by DYSIS Medical. Using non-standard cables may result in user and/or patient hazard and/or device failure. Prior to moving DYSIS Ultra, please ensure provider touchscreen and patient screen are folded above the base, and the optical head arm is folded and locked at its magnetized joint. Never use your hands to engage or release the foot brake. Before moving DYSIS, make sure that the foot brake has been released and the wheels have been lowered. Always engage the foot brake before an examination. DYSIS should be positioned on a flat surface and the foot brake engaged to prevent movement and toppling. Make sure you examine the functionality of the arm every time you are about to examine a patient and ALWAYS before proceeding to connect a DYSIS speculum. Connect only accessories that are specified in this guide as part of DYSIS or that have been specified as being compatible with DYSIS. To avoid the risk of electric shock, DYSIS must only be connected to a power supply with protective grounding. Never attach the DYSIS speculum to the imaging head before inserting it into the vagina. Do not apply any force on top of the imaging head during an examination or at any other time (especially if a DYSIS speculum is connected). Do not apply any force to the speculum connector of the imaging head. The speculum connector should never be used as a handle to move the device. Sequence of actions to power up the device:

• Connect the main power cable to the appropriate outlet, or (if already connected).

• Press the power button.

• The computing unit will power up and the software application will start. Sequence of actions to power down the device:

• Press SHUT DOWN button (using the touch screen) from the left panel. DYSIS will shut down automatically.

• To avoid power consumption when idle, turn the power button to the OFF position on the base after the unit has completely shut down.

The DYSIS calibration card should be maintained so it stays clean and in good condition. Ensure any external data storage media has been checked for malware (viruses, trojans, etc.) before connecting to DYSIS. Do not spray solutions or liquids into air vents. Do not immerse any part of the device in cleaning solutions.


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Do not sterilize any part of the device. If the device is accidentally contaminated during an exam, use the indicated disinfecting solution to clean it based upon the contamination. Before disinfecting, the device needs to be powered down and the power cables should be disconnected. Wear the proper Personal Protective Equipment (PPE) when disinfecting any part of the device.

(This Caution Symbol Applies to the Safety Cautions Below) Do not stare directly at the light source in the imaging head unit. Using the handle of the imaging head to transport the device may result in a loss of device performance and stability and could cause injury to the user/patient. To ensure optimal operation and safety, users should not remove any of the connectors on DYSIS. When using the acetic acid applicator, the acetic acid container should not be over-filled. Do not spray any liquids if the tubes of the spray mechanism have been disconnected or detached. The DYSISmap is not meant to replace conventional colposcopic assessment and decisions regarding biopsy sampling, treatment or diagnosis. The assessment of acetowhitening should be based on visual inspection of the entire set of the acetowhitening characteristics. The DYSISmap reflects a subset. When using different concentrations of acetic acid, the acetowhitening characteristics may change and consequently the corresponding color coding of the DYSISmap to certain degrees of acetowhitening.

(This Consultation Symbol Applies to Consultations Below) When adjusting the image brightness, the user should view the monitor directly and not from the side or from below, as this may distort the perception of the color and brightness. Before a DYSISmap measurement, check there is a sufficient volume of acetic acid solution 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 movements should be minimized.


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The user annotations are digital marks overlaid on the displayed image and do not follow the movements of the cervix. Therefore, the annotations should be used with caution if the cervix moves after marking. Access to the database is restricted to unregistered users. The “Required” fields in the “New Patient” form are mandatory. The patient data is saved only upon pressing SAVE.


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Apart from the device label, the following warning labels are found on DYSIS or within this document.

The attachable speculum, if reusable, is a Type-BF applied part that provides protection against electric shock.

Follow DYSIS Ultra operating instructions.

CONSULT: Refer to instruction manual/booklet NOTE: This symbol is used to signify the instruction manual/booklet must be read

General warning sign.

Hand crush warning.

Do not push DYSIS Ultra.

Do not step on DYSIS Ultra.

LED emission

Class 2 LED product warning

Details of LEDs used in imaging head


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5.1. Location of Labels The product label (containing the device name, serial number, DYSIS Ultra legal manufacturer address and Unique Device Identifier Barcode) and the warning labels are located on the back of the PC enclosure.

Product and warning labels are included on each device like the examples below:

Product Label - containing the device name, serial number, DYSIS legal manufacturer address, Unique

Device Identifier Barcode

Warning Label – containing iformation on LED radiation, wavelength and do not push / do not

stand labels


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6. Classifications DYSIS Ultra digital colposcope is a Class-IIa device according to the 93/42/EEC Medical Device Directive and a Class-II device in the USA. DYSIS Ultra is a Class-A Software Medical Electrical Equipment product as per IEC 62304 – no injury or damage to health is possible as a result of using the software. DYSIS Ultra is a Risk Group 2 LED product according to IEC/EN 60825-1. According to EN/EC 60529, the degree of protection for the components is as follows:

• Monitor - IP54 compliant front panel (IP52 housing) The DYSIS reusable metal speculum is a Type BF applied part and the DYSIS disposable speculum is a Type B applied part per International Electro-technical Commission (IEC 60601-1), according to the type of protection against electric shock. The DYSIS Ultra imaging head is not an applied part but could accidentally come in contact with the patient. The imaging head and the positioning arm are protected by double insulation which prevents the patient from coming into contact with the electrical system. The power supply used with DYSIS Ultra is Class II. Refer to technical documentation for more information on electrical safety per IEC 60601-1. Mode of operation; DYSIS Ultra is classified for continuous operation.


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7. Environmental Conditions

7.1. Storage DYSIS Ultra should only be stored in environments where temperature ranges between 32°F to 122°F (0°C to 50°C) and humidity up to 95% (non- condensing).

7.2. Usage DYSIS Ultra should only be operated in environments where temperature ranges between 50°F to 104° (10°C to 40°C) and humidity up to 90% (non-condensing).

7.3. Transportation During shipping, DYSIS Ultra can withstand a temperature range between 14°F to 122°F ( -10°C to 50°C) and humidity range of 5% to 95% (non- condensing).

7.4. Atmospheric Pressure There is no impact from atmospheric pressure on the device and it does not require any gases to function.

8. Usage Restrictions DYSIS Ultra is not meant to be used in any way other than the intended use stated by the manufacturer. Any effect on basic safety, reliability and performance of DYSIS is the manufacturer’s responsibility only if: Appropriately trained DYSIS Medical personnel carry out assembly/test operations, extensions, readjustments, modifications or repairs. The electrical installation of the relevant room complies with the appropriate requirements and DYSIS Ultra is used in accordance with the instructions for use. Users must read the instructions in this guide carefully before operating the device. DYSIS Ultra must not be used if it appears to be damaged or broken. There are no user replaceable parts in DYSIS other than the acetic acid applicator and the fuses. DYSIS Acetic Applicator (ACE004) is recommended to be replaced on a monthly basis. Apart from the speculum and smoke extractor treatment pipe, the DYSIS Ultra is not intended to come into contact with the patient. Users and patients should not stare directly into the illumination source when DYSIS is ON. Air vents must be kept unobstructed. Do not sit, lean or step on DYSIS Ultra. Do not place any items (such as instruments, coffee, weights, etc. on DYSIS). Do not push or pull DYSIS Ultra in a way other than outlined in this guide or instructed by DYSIS Medical for proper operation. DYSIS Ultra should only be connected to a grounded hospital grade outlet.


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9. Components of DYSIS Ultra

1 - Display Arm (ARMD) including Clinician Monitor 2 - Optical Arm (ARMO) holding the Imaging head 3 - Imaging head (OPTI) 4 - Base including the system PC (BASE)

9.1. BASE / Moving the Instrument On the base, there is a foot pedal to engage/disengage the brake. In order to move DYSIS Ultra, the brake should be disengaged. To disengage the brake, push the green pedal down 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 engage the brake.

9.2. ARMS To place DYSIS Ultra in the most suitable position for use, both arms can be easily adjusted. It requires minimal effort for repositioning and are not required to be locked in position. When opening the arms, support must be given to the imaging head until the lower arm is in a ‘V’ position where it will engage the gas strut. Failure to do this can result in the imaging head ‘falling’ a little, which could result in damage if it is close to other objects.

1

3 2

4


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9.3. Clinician Monitor The clinician monitor is a touchscreen monitor. It is used during the colposcopic examination to perform the procedure. (see Section 20 for DYSIS Examination)

9.4. Imaging head The imaging head consists of a camera with LED lighting and DYSIS acetic acid applicator system. The speculum is also attached to the imaging head using the speculum connector.

9.4.1. Camera and Light The camera in the imaging head contains LEDs which provide illumination during the colposcopic examination and execution of the DYSISmap. This product meets the power requirements for a Class 2 LED product to IEC/EN 60825-1:2007 under normal operating conditions and those of single fault failure. Warning: Since the imaging head emits radiation (wavelength 440 to 633nm, widely divergent and with maximum average power of 7.4mW), it is imperative the user does not stare into the beam in order to prevent damage to their eyes. Caution – Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. The camera and light are automatically on when in examination mode.


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9.4.2. DYSIS Acetic Acid Applicator An automatic spraying system (for acetic acid application) is integrated into the imaging head. (See Section 25.12 for changing the DYSIS Acetic Acid Applicator).

9.4.3. Speculum Connector The DYSIS speculum is attached to the imaging head following insertion and houses the acetic acid diffuser. This can be detached if not required by squeezing the inserted end of the connector and pushing back through the hole. It is considered a part of the DYSIS acetic acid applicator kit. The DYSIS acetic acid applicator will be still connected. Be careful not to pull the tubing.

10. Power cord and Power On/Off DYSIS Ultra should only be used with the supplied AC/DC power supply unit.

DYSIS Ultra should be isolated from the main power supply by switching off the unit.

11. Assembling and inserting the power cord Insert the end of the power cord into the power brick. To insert the power cord into the PCU, 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 position. It will be locked into the device.


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To remove the power cord once DYSIS Ultra has been shut down, pull back on the yellow tab, turn 45 degrees to the left until the notches are lined up and pull out.

12. Accessories The following accessories are available for use with the instrument: - DYSIS acetic acid applicator with specula connector - Disposable Speculum – class I sterile - Reusable Speculum – class I - Disposable treatment pipe for LEEP’s


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13. Powering on DYSIS Ultra To power on DYSIS Ultra, ensure it is plugged in to a power supply and press the green power switch on the BASE (above the power plug). The DYSIS software should launch automatically when powered on. DO NOT TOUCH THE BUTTONS ON THE BACK OF THE MONITOR. FAILURE TO FOLLOW THESE RECOMMENDATIONS, CAN RESULT IN MONITOR MALFUNCTION.

14. Powering Off DYSIS Ultra To turn off DYSIS Ultra, press SHUTDOWN from the left panel of the HOME screen or from the LOGIN screen, and wait for DYSIS to shut down. DO NOT SWITCH DYSIS ULTRA OFF BY UNPLUGGING THE POWER CORD OR TURNING OFF THE POWER SWITCH UNTIL IT HAS SHUTDOWN FROM THE TOUCHSCEEN. FAILURE TO DO THIS CAN RESULT IN LOST DATA. DO NOT TOUCH THE BUTTONS ON THE BACK OF THE MONITOR. FAILURE TO FOLLOW THESE RECOMMENDATIONS, CAN RESULT IN MONITOR MALFUNCTION.

15. Overview – Operating DYSIS Ultra DYSIS Ultra 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 tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The DYSISmap feature analyzes synchronized still images after acetic acid application to present a color-map overlay intended to help clinicians visualize aceto-whitened areas of the cervix. Use of the DYSISmap feature is NOT a substitute for conventional colposcopic. When using DYSIS Ultra with DYSISmap, the user must ALWAYS first conduct a thorough colposcopic examination and identify and select areas for biopsy. The DYSISmap feature can be used to identify, where appropriate, one or more additional biopsy sites. NEVER cancel any of the biopsy sites initially identified with conventional colposcopy. The software embedded in DYSIS has been designed to ensure compliance with this requirement. Therefore, the examination process will proceed as follows:

Examination preparation Initiate DYSISmap procedure Colposcopy examination (including application of acetic acid to observe acetowhitening effect) Select biopsy points as needed (after standard colposcopic assessment)


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Select initial colposcopic prediction Observe DYSISmap Select additional biopsy points as needed Take all selected biopsies and label appropriately Select final colposcopic prediction

These steps are expanded in detail in the following sections: 19.5 - 21

16. DYSIS Acetic Acid Applicator Kit

The DYSIS acetic acid applicator kit is filled by removing the bottle from its holder, unscrewing the lid and filling just below the shoulder level. Screw the base back into the lid and replace in its holder. Press the PURGE button

from the option button on the home screen repeatedly until the acetic acid is sprayed from the spray nozzle, the syringe is fully filled and most of the air is expelled from the tubing. Please see section 25.12 for instructions on how to change the DYSIS acetic acid applicator, a warning message will be displayed every 30 days prompting the DYSIS acetic acid applicator to be changed.

17. Positioning for an examination To position DYSIS Ultra next to the examination table prior to operation, considerations to be taken into account are:

• Space available

• Position of power outlets

• Left or right-handed operator

• Type of examination table Ideally, DYSIS Ultra should be positioned next to the exam table with the optical arm under the patient’s leg and the monitor arm over the patient’s leg. The arms can be positioned easily and do not need to be locked into place. The brake should be accessible to the user or staff to disengage and move it easily should the patient require emergency treatment at any time.


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18. DYSIS Ultra Software Application

18.1. Logging In After turning DYSIS Ultra on, the user must LOGIN to access the application. The application displays a keyboard on the touchscreen and prompts the user to provide a username and password (default usernames and passwords are provided upon installation as per 0230-53070 DYSIS Ultra Installation Guide and can then be customized). After completing the requested information, the user presses LOGIN to enter the Home menu to access a patient record or proceed with an examination.

18.2. Home Menu The DYSIS Home Menu is the central navigation point of the software and allows users to access the patient records from PATIENT DATABASE, start an examination via DYSIS EXAM, create a NEW PATIENT record or

access the settings pages from the button.


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From the Home screen, the user can enter a NEW PATIENT, Start a DYSIS Exam or open the PATIENT DATABASE to review previous visits or add a new visit to an existing patient record by selecting the corresponding button.

As well as the home menu, other options are available by selecting the icon on the left upper corner, which expands a side panel with additional functions. From this expanded panel, the user can change SETTINGS to set or change the device accessibility, PURGE the DYSIS acetic acid applicator, Calibrate the system, LOG OUT to log out of the application and SHUT DOWN to terminate the operation.

18.3. General navigation buttons

In some menus, the button will return the user to the previous screen. Alternatively, in other modes of use,

the button will offer the option to return to the previous screen after a message has been acknowledged (during the mapping process).

Will offer a return to the Home menu, dependent on the mode.

Will take the user to the settings menu from the home menu. It will also allow the User to PURGE the DYSIS acetic acid applicator, LOGOUT and SHUTDOWN See section 15.

A separate menu is available from the button when in examination mode see section 19.6

Will close the menu and/or software in use.


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18.4. Calibration of the System This procedure is performed on a weekly basis. A label on the home screen will display when the calibration will expire. A calibrated system is required in order to proceed with the mapping procedure. A DYSISmap will not be calculated if the system is not calibrated. CALIBRATION of the system will be available through the left panel of the HOME screen.

For the calibration procedure, the user should press the two pins on the rear end of the speculum connector rod and remove it from its mount. Then, the user should place the grey card on its mount (jig) and connect it to the speculum connector.

By pressing the calibrate button, the following screen appears:


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After pressing START, the user should follow the instructions as 3 sequential messages are displayed:

After confirmation of the above messages, the software will attempt to focus, calibrating the colors. When completed, a message will be displayed. The CLOSE button should be pressed to return to the HOME screen.


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18.5. Creating a New Patient Record To create a record for a new patient, select NEW PATIENT and use the touchscreen to enter personal identification information and additional demographic data. The cursor can be moved to any field by clicking inside the text box or pressing the tab key on the keyboard. In addition, NEXT can be pressed on the touchscreen to move between data sets. To successfully create a patient record, the fields marked “Required” must be completed and then press SAVE.

Additional information can be added by selecting each icon from the NEW PATIENT screen including address, general information and obstetric history.


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All information will be saved to the patient record by pressing SAVE

18.6. New Visit for an Existing Patient To create a NEW VISIT for an existing patient, select the patient from the database by entering PATIENT DATABASE from the home menu and selecting the patient by scrolling 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 will order the content alphabetically or numerically. After selecting the patient, select NEW VISIT from the boxes highlighted at the bottom right of the screen. A NEW VISIT record will be created. Information on the NEW VISIT can be entered in the same way as described in section 19.1


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After selecting the patient, the New Visit button is enabled


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19. DYSIS Examination Preparation and Functions

19.1. 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 additional information within the record by touching the corresponding box including:

REFERRAL REASON: The reason for the colposcopy


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PATIENT STATUS: Add additional patient information

19.2. Using DYSIS to perform an examination of the Lower Genital Tract without mapping

To use DYSIS Ultra to carry out an examination of the lower genital tract, first create A NEW PATIENT record as described in section 18.5, or add to an existing patient record as described in 18.6. Then press DYSIS EXAM. Or press DYSIS EXAM from the Home screen. The camera and light will switch on automatically. Assign any saved images following the examination to a patient record following the procedure in section 19.1.

This screen offers the option to magnify the image by using the and buttons or by ‘pinch zooming’ the image. At this stage, no images will be saved. Focus can be achieved through the right-side menu of the DYSIS

Exam screen by using the buttons or by moving the IMAGING HEAD closer to or further away from the subject. Additional functions are offered through the right-side menu of the live image screen, such as:

This allows the user to save individual still images which can be labeled when the on screen keyboard appears which is prompted by selecting the CAPTURED IMAGE box.

Allows the user to record video. A warning message will appear when the video reaches 4 minutes in length.

Displays a green filtered light over the color image. To deactivate the filter, press the button again.


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Enhances the contrast of the image. To deactivate, press the button again.

Option to enable/disable the polarizers Polarizers On: This mode is used during mapping. Surface reflections are eliminated. Polarizers Off: This mode is used for general examination. It offers an enhanced 3D perception and color vividness.

To exit and save the images/videos, press the button from the upper left corner and select

or simply press .

19.3. Assigning a visit after a DYSIS Exam from the Home screen After saving images, videos or having performed an examination, exit the DYSIS exam screen and the following screen will appear:

The user can either create a new patient where the examination will be saved, select an existing one or press CANCEL. By pressing CANCEL, the examination will be discarded and a confirmation message will be displayed.


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19.4. Using DYSIS to perform a standard colposcopic examination The user can start an examination by selecting DYSIS EXAM either from the home menu (without entering patient information), or after initiating a new visit for a specific patient (see section 18.6 above) or by creating a NEW PATIENT record (see section 18.5 above). When the examination is initiated from the home menu, the user will be prompted to assign the examination data to a patient record after the completion of the examination by selecting a patient from the PATIENT DATABASE, creating a NEW PATIENT record or pressing CANCEL to discard the examination data. After selecting DYSIS Exam, the imaging head is automatically turned on and the camera and light are operational. The user can observe the image in the field of view of the camera on the touch screen in order to perform a standard colposcopic examination.

19.5. Preparing the patient Follow standard clinical practice to insert the speculum. Adjust the speculum to achieve the optimal field of view. Gently remove any mucous using a dry swab or saline. Do not clean with acetic acid since it will start the acetowhitening process. Ensure the connecting rod for the speculum is positioned posteriorly. DYSIS can be connected to the speculum via the connecting rod located at the front of the imaging head after insertion to stabilize the image during the examination. It is connected by pushing the end of the speculum into the opening on the green connector rod from the imaging head. This does not lock into place, but will stabilize the image during the examination.

The clinician monitor is a touch screen. From the DYSIS exam screen, the magnification can be increased

or decreased by using the or by pinching or expanding the screen zoom with your fingertips.


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Examination Screen In the DYSIS Exam Mode, several tools and options are available. During the examination, the user has access to the operations/functions outlined below.

Symbol Function Description

Save Image

Takes a still image for the patient record of the current view. Can be taken while filters are applied or when image is zoomed. Images are automatically numbered sequentially, but can be labeled individually using the on screen keyboard when the captured image box is selected

High Contrast Filter

Enhances the contrast of the image. To deactivate, press the button again

Green Filter

Displays a green filtered light over the color image. To deactivate, press the button again

Brightness Control

Allows the brightness of the image to be increased or decreased manually

Focus Manually sharpens the focus


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Initial prediction

By pressing this button, the user selects the initial colposcopic impression (normal, low, high)

Video recording

Enables video recording without a DYSIS Exam. Touch to activate and deactivate

Start Opens the examination options

Polarizers ON/OFF

An extra filter will be available when on examination screen Only available prior to mapping and after the mapping During the mapping, it will be fixed to polarized view

Back button

Exit the examination; an option to save the acquired data will be displayed

Additional options

Opens additional panel for viewing saved images, or to Exit the examination.

19.6. Additional Options

From the DYSIS Exam Mode, additional options are available from prior to and during the examination.

Examination Screen (with left menu shown)


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Shows Saved images

Displays images that were taken and saved

Cancel Exam

Cancels the examination

20. Starting the DYSIS Exam

To start the DYSIS Exam, select . This will open additional examination options.

Examination Screen (having pressed Enter DYSIS Mode)


Marker for os

Add or remove marker for the opening of the cervical os. First touch the option then select the area on the touchscreen

Biopsy Markers

Add or remove biopsy markers during the examination and after the map review


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Start Starts the DYSIS mapping

Prior to starting the DYSIS exam, ask the patient to remain as still as possible. After pressing Start DYSIS Mapping, 1.5 cc of acetic acid will be diffused homogenously over the cervix and the mapping process will begin. Do not put anything in the speculum as the device is mapping or a map may not be calculated. During the mapping process, a thorough colposcopic examination should be completed by the user. Areas can be magnified during the examination, filters applied to enhance different features such as vascular patterns, atypical vessels, mosaics or punctation and improve the colposcopic imaging. Biopsy markers & os can be

added or deleted using the relevant buttons. Still images can be taken and saved. High-resolution still images can be saved by pressing the camera button. A dialog box with an image preview and a keyboard on the touch screen will prompt the user to enter a comment that will be included in the image filename (by default, the images are sequentially numbered). Images are saved in a high resolution and quality png (*.png) format that can be later exported to a USB or printed.


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Examination Screen (during mapping) During the examination, a timer will display in the right corner of the touchscreen. It requires at least 125 seconds of information for the map to be calculated and will automatically stop at 185 seconds. The

examination can be stopped manually by pressing . If this is done prior to having enough data recorded, no map will be calculated and a warning message will be displayed. If STOP is selected after approximately 125 seconds, the timer will turn green and a map will be calculated. A message will be displayed asking if you wish to terminate the process and must be acknowledged for the process to be stopped.

During the mapping process, the user must enter their colposcopic impression of the examination– either NORMAL, LOW or HIGH according to their observations. When using DYSIS Ultra, at any moment during dynamic Imaging, the user can review the images that have

been captured thus far by pressing the playback icon. The playback can be accessed by selecting the button at the bottom of the screen in live viewing. A set of controls are accessed which allows the user to advance the images at 2x normal speed, 5 x normal speed and individually.


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The user can use forward/backward buttons displayed on the touch screen to scroll through the images manually, or let them play continuously and select the playback speed. The images can be reviewed on a popup window which can be moved around.

Click on the button to return to the live view.

Examination Screen (with the exam playback panel shown) After the examination, brightness, focus adjustments, button for enabling/disabling polarized view and video recording will be available again. Additional options will be added to the right menu.


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Examination Screen (after the map calculation)


Show Map Displays the DYSISmap over the live image of the cervix

Show Graph

Displays a graph of the acetowhitening process in the left upper corner to review the response to the acetic acid.

PLEASE NOTE: The user must ALWAYS select biopsy points based on the conventional colposcopic examination before the DYSIS system will display DYSISmap. If no biopsy points are indicated, when “Show Map” is selected to view the DYSISmap, a dialog box will appear asking to confirm that no biopsy points are indicated by conventional examination.


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20.1. The DYSIS Map

Examination Screen (DYSISmap ON) DYSIS Ultra will document the dynamic optical phenomena associated with the acetowhitening effect in a color-coded map (DYSISmap). DYSIS Ultra captures high-resolution, sequential images. The images are automatically aligned to compensate for tissue micro-movements and then are used to calculate the DYSISmap. The mapping feature should be used as an adjunct to the colposcopic examination and always after the 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 color-coded map but viewing the DYSISmap should never lead to the cancellation of biopsy sites selected during the conventional colposcopic exam. The DYSISmap captures and documents the tissue acetowhitening dynamics (intensity over time). The continuum of colors of the DYSISmap ranges from cyan to blue to green to red to yellow to white and denotes a progressively stronger acetowhitening response. The table below represents the color code used to document the tissue acetowhitening dynamics as depicted by DYSIS Ultra. This color assignment is based on the intensity and duration of acetowhitening over the time period of the dynamic imaging procedure.


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Color coding Whitening White

Intense Yellow

Red Strong Green Dark blue Weak

Cyan Very Weak

No Color Very weak/ None

After viewing the map, the initial prediction button is turned into the final prediction. Prior to closing the exam, the user must enter the final impression. A warning message will be displayed if this step has not been completed.

20.2. Dynamic curves

After Dynamic Imaging, users can also review the dynamics of the acetowhitening response of the tissue at any location on the cervix, by pressing “Show Graph”. This displays a graph on the upper left corner of the touchscreen. It can be moved around the screen to a convenient location. The vertical axis represents the acetowhitening intensity and the horizontal axis represents the time since application of acetic acid.


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Examination Screen (DYSISmap & graph shown) By touching the screen at different sites on the cervix using the image on the touch screen, it is possible to view the response at different sites. This tool can facilitate the review of the acetowhitening phenomenon at different locations simply by monitoring the variations in acetowhitening intensity (curve height) over time. This function is only available after the map has been calculated and viewed.

20.3. Adding additional biopsy markers

Additional biopsy markers can be added after the map has been displayed by selecting .

The biopsy markers that were added prior to the map will be displayed in bright blue and those chosen after the map will be orange. A maximum of 5 biopsy markers can be added.

20.4. Biopsy point viewing Prior to the biopsy procedure, the “Hide Map” button can be selected and the DYSISmap will be removed from view, leaving the biopsy points visible on the live image of the cervix.


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The user annotations are digital marks overlaid 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 of the cervix is magnified, they will align with the area of interest.

20.5. Exiting the Exam To finish the examination after all desired data has been recorded and operations (e.g., biopsy sample collection) completed, the user must press the SAVE and EXIT EXAM button on the right lower corner of the screen.

Alternatively, pressing the button will also exit the exam.

21. Additional information post colposcopic examination Clinical findings during the DYSIS Exam and management plan can be entered by selecting pre – populated boxes in the sections below. In addition, notes and drawings can be entered free hand by using the touchscreen by selecting Memo.


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COLPOSCOPY: Colposcopic findings after the examination. The COLPOSCOPY screen is automatically displayed after exiting the live image screen.


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MANAGEMENT PLAN: Management plan following the examination. Additional management plans can be entered after the histology results are completed.

HISTOLOGY RESULTS: Enter per point histology results for biopsies taken.

NOTES: Area for additional information can be typed into the record by using the on-screen keyboard.


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The right side of the screen offers additional post colposcopy options.

Replays the DYSIS exam (all the sequential images that were automatically captured during examination)

Allows the user to draw freehand on the DYSIS touchscreen

Allows the user to view the customized visit report

Exports the entire individual visit to a USB or Ethernet connection (please see Appendix 1 Bi connectivity belowError! Reference source not found.)

A record of additional information entered after the patient record has been closed

Guidance for the clinician

Save all data and exit the record


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22. Patient Database The patient database offers up to a maximum of 1 TB of data, approximately equivalent to over 5000 DYSIS examinations. (This storage capacity will vary according to the 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 be detailed in alphabetical order according to order of the visit.

To search the PATIENT DATABASE, the user can select the LAST NAME, FIRST NAME, PATIENT ID or LAST VISIT Tabs which will display visits alphabetically and numerically in that column.


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Alternatively, by selecting the box above any of these columns, the touchscreen keypad appears and the patient database can be searched more specifically by completing any of these boxes. Highlighting the patient in the database list will display a list of their visits on the right side of the patient record.

OPEN in the top right corner will open a more detailed copy of the patient’s record and visits after the patient is selected. Highlighting a specific visit will allow the user to view that patient visit record and record card. Press REVIEW VISIT to view


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In addition to reviewing the patient visit record, the user can use EXAM PLAYBACK to review the images and add HISTOLOGY RESULTS after the visit.

Exam Playback screen (reviewing a visit)


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Filters can be applied and additional images saved while reviewing previous visits. Show Map

Histogram is available when reviewing the aligned images when a map is available. By selecting, the color distribution of the map will be displayed.

22.2. Visit History The DYSIS patient records can be amended at any time after a visit and those changes will be tracked. For example, if a patient’s referral reason was not available at the time of examination but the result is to be entered for audit purposes, the information can be entered by selecting the appropriate boxes in each section. When the record is closed, a box will appear asking the user to confirm the entry and the reason for it. By pressing NEW INFO or ERROR, the user confirms the reason for the change entered. It can then be confirmed or discarded.

Following confirmation, the added or changed information will appear in the VISIT HISTORY section of the patient record.


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22.3. SMARTtrack SMARTtrack allows the user to compare different visits, which occurred on separate occasions, together, allowing linear tracking of patient management and outcomes. To use SMARTtrack, first select the patient from the database. Highlight a specific visit to include in the visits for review and press SMARTtrack.


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When is displayed, both visits can be viewed independently. When this symbol is aqua and unlinked, both sides can be manually played and images paused or advanced separately. Each visit is controlled by a set of buttons below each image and the map histogram is displayed respectively below each visit.

When the chain links are locked the images will play, move and magnify simultaneously controlled by a single set of buttons at the bottom of the screen.

By clicking on the padlock symbol , the user will be able to lock one image 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 7 second

intervals), at normal speed and normal speed, by selecting the appropriate option.

Using and buttons, the images can be advanced or reversed individually. The time of each image is displayed on the right side of each screen.

When on Aligned images, two buttons become available: .

By selecting ,the map will be displayed and hidden over the reference image. By selecting , chosen biopsy points will be displayed and hidden over the reference image.

Allows the user to increase or decrease magnification of individual Captured images and is available for each exam reviewed. It is also possible to pinch zoom the image as during live viewing.


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To change the exams for comparison, select a visit from the box below each image and select the exam to review. They will be uploaded into the viewing area. Captured images can also be reviewed which reveal movement during the exam, as well as aligned images which reduce the field viewed but aligns the images to remove any movement during the map. When viewing images in SMARTtrack, a graph is displayed below the images. The graph demonstrates changes in the map over the two visits. The user should select each viewing area on the images to review. The graph displayed below the locked images will show the difference in the map between the two corresponding areas. 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 center line, illustrating the amount of reduction in each color. If the aceto-white response is greater between the two visits, the graph will show a positive value above the center line. The graph will represent only what can be seen in the view on the touchscreen. This feature eliminates less relevant characteristics and aceto- white values from the graph.

23. Downloading or Printing a Report To print or download a patient report, first select the patient from the database and select the individual visit to be printed. Select individual images from the row at the bottom of the screen by pressing the INCLUDE IN REPORT then select REVIEW REPORT. Images captured independent of the mapping process by the user will be automatically be included in the report. To deselect these images, press the X to grey out the image and eliminate from the report. The report will be displayed including patient demographics, REFERRAL REASON, COLPOSCOPY findings, MANAGEMENT PLAN and HISTOLOGY RESULTS. It will also include any images selected and any notes entered in the NOTES section of the patients visit record. Then by selecting EXPORT TO PDF, PRINT REPORT or CLOSE the report can be exported to a USB stick, printed if a printer has been connected to DYSIS Ultra or closed.


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24. Additional Functions In the SETTINGS menu, DYSIS Ultra can be configured according to local requirements. Functions include exporting individual cases or the entire database to a remote server, SCREEN LOCKOUT and other functions. Access to the settings functions are via an Administrator password only, which can be set by your DYSIS

representative upon installation. To enter the SETTINGS menu, log in and select the symbol in the top left corner of the HOME MENU and select SETTINGS from the side panel.

A description of each section of the SETTINGS menu available to administrators is available at Appendix 1: ADMINISTRATOR SETTINGS.

24.1. Info The INFO tab will show the software version in use, for example 1.0.5. In addition, serial numbers of components such as the camera are displayed. It is important to know this information when reporting any technical issues to the DYSIS service and maintenance team.

24.2. Password tab The PASSWORD function allows individual users to manage their own login and passwords. Users with clinician level access can manage only their own passwords through the Password tab. Users with ADMIN access are able to manage passwords for all staff via the USERS tab, change access levels and delete existing users as well as add new users. User names and passwords are case sensitive, passwords need to be at least five characters. Please enter information in all fields shown, LOG IN NAME, REAL NAME and PASSWORD to create new users.

25. Care, Maintenance and Troubleshooting

25.1. General When not in use, DYSIS Ultra should be covered with a dust cover. Prior to cleaning DYSIS Ultra, turn off the power by shutting down the DYSIS, press the OFF button and unplug from the main power outlet Do not immerse any part of DYSIS Ultra into cleaning solutions.

When not in use, DYSIS Ultra should be stored with lower arm folded against itself, utilizing the magnet at the top of the arm to ensure the arm is locked into place. The upper arm should be folded back on itself in an


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upright position, with the monitor over the base to ensure the monitor and imaging head are protected when DYSIS Ultra is moved. When moving DYSIS Ultra, the user should release the footbrake and push the metal pole. Do not push DYSIS Ultra using the arms, imaging head or monitor. Care should be taken to protect exposed parts when maneuvering.

25.2. Replacement of Parts All parts of DYSIS Ultra colposcope are replaceable and this operation should only be performed by DYSIS Medical representatives. Circuit diagrams are available from a DYSIS Medical representative upon request.

25.3. ARM, BASE and Computer Housing Cleaning To remove stains, wipe DYSIS Ultra with a soft cloth lightly moistened with a mild detergent solution. Do not spray solutions on to DYSIS Ultra. Be particularly careful to ensure there is not ingress into air vents on the back of the CPU or connection ports, switches and buttons.

25.4. Touchscreen Monitor Cleaning The touchscreen monitor can be cleaned with a damp cloth moistened with a mild detergent solution. Special cleaning products should not be used. Stubborn stains should be cleaned gently in the same manner. Excessive moisture or pressure should not be used.

25.5. Imaging head Cleaning The imaging head can be cleaned by wiping with a damp cloth moistened with mild detergent. The glass cover over the camera lens at the front of the imaging head can be cleaned with a cotton cloth or lens tissue moistened 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 MOVEMENTS – EITHER UP AND DOWN OR SIDE TO SIDE.


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25.6. Disinfection

If needed, DYSIS Ultra can be wiped with a soft cloth dampened with 70% isopropanol alcohol, disinfectant wipes (chlorhexidine for viral control) and similar substances. DYSIS Ultra is not intended to be sterilized. Refer to cleaning instructions in 0230-53059 - DYSIS Ultra Colposcope Cleaning and Maintenance Instructions.

25.7. DYSIS Specula DYSIS Specula are either reusable stainless steel or disposable single patient use devices. After use, the disposable specula should be disposed of according to local clinical guidelines. For detailed information, please refer to 0230-53004 DYSIS Reusable Care and Maintenance Instructions and 0230-53028 DYSIS disposable speculum IFU.


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25.8. DYSIS Acetic Acid Applicator The acetic acid applicator does not come into contact with the patient at any time. The applicator kit should be purged with acetic acid prior to use and purged with sterile water then air at the end of each session, by pressing the purge button on the touchscreen. The DYSIS acetic acid applicator should be replaced on a monthly basis (please see section 25.12). The DYSIS acetic acid applicator consists of the syringe, an acetic acid reservoir, luer lock, spray nozzle and silicon tubing. If the local clinical practice is to store and maintain acetic acid in sterile conditions, it is strongly recommended the kit is sterilized before use. This can be achieved by using a commercial sterilization fluid, which should be used according to the manufacturer’s instructions. Ensure the sterilization liquid reaches all parts of the kit, by filling the reservoir with the sterilization 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). Purge the sterilization fluid from the applicator by repeating these steps using sterile saline or sterile water until cleared. The acetic acid solution should be labeled and discarded/changed per facility protocol. If daily or periodic cleaning is required per facility protocol and a sterile solution is not required, the acetic acid solution can be poured out of the acetic acid reservoir and the reservoir rinsed. To clean the tubing, pour 10 ml of water into the reservoir. The tubing can be flushed by pulling back the syringe, depressing the syringe while holding a paper towel in front of the diffuser.

25.9. Periodic Cleaning and Maintenance The user should clean and maintain the DYSIS Ultra (monitor, base, imaging head, arms, pole etc.) on a monthly basis as per cleaning instructions.

25.10. Routine Electrical Testing The DYSIS Ultra electrical system consists of two parts; 1) the 240v double insulated ( ) power pack and 2) the 12v DYSIS Ultra instrument. The power pack can be tested to meet current electrical testing requirements for class 2, double insulated devices. The DYSIS colposcope is below the SELV limits of 50 V ac and therefore does not require any routine electrical testing to be performed.

25.11. Troubleshooting DYSIS Medical discourages the performance of any maintenance, troubleshooting or service actions on DYSIS Ultra other than those specified in this guide. If DYSIS Ultra malfunctions, or if there is a suspicion that it underperforms, please follow the guidelines below before contacting the DYSIS Medical service department. This will facilitate and expedite identification and solutions to the problem. Before performing any troubleshooting action, please make sure the power cord is connected and note if the indicator light in the rear of the main unit is lit. The following table lists specific issues which may be experienced with DYSIS Ultra. Observe all safety precautions and warnings and make sure to carefully read and fully understand the instructions for use before

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attempting any of the troubleshooting. Make the instrument is shut down, disconnect from the power source and restart the unit before contacting technical support. If any of the suggested actions fail to solve the issue, please contact the DYSIS Medical service department.

25.11.1. Troubleshooting guide

Description Possible Cause(s) User Action

The imaging module does not maintain its position

Arm is not extended enough

Make sure that the arm is extended enough so that it is in the “V” position

Image is fuzzy, unclear or dark Front imaging element may be dirty

Clean front glass element

(See section 25.5)

No image on the touch screen

The signal or power cable is disconnected or damaged

Contact service support

Graphics card malfunction Contact service support

Computing unit does not turn ON when power button is pressed

Cabling going into the power brick or into DYSIS’ base may be loose/disconnected

Check connection; if problem remains, contact service support

Computing unit malfunction


Computing unit turns on, the software functions, but the DYSIS Exam button is disabled

Camera malfunction Shut down the device and start it up. If the problem persists, contact service support

Dynamic Imaging cannot be initiated

Error in plunger

Check that there is sufficient acetic acid solution in the container & through home menu, press “purge syringe”. If problem persists, contact service support.

System’s locale is setup as US and calibration is required.

Calibrate the system

Image is displayed, but illumination does not turn on

Illumination source malfunction


DYSIS doesn’t turn on

Main power cable is disconnected

Make sure that the main power switch is OFF and reconnect the main power cable at the power brick & the power cable is locked into the DYSIS base. Turn the main power ON

Outlet has no electricity Make sure there is the appropriate supply at that outlet

System malfunction Contact service support

Calibration cannot be performed

The card is not at the right distance

Try focusing accurately

The card is very dirty Contact service support



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Software update cannot be performed

The USB stick is not recognized

Try using another USB stick or a USB hub

The configured network path where the upgrader is, is not accessible.

Check connections to ensure that the configured network path is accessible.

The DYSIS Ultra software upgrade is not on the USB stick

Follow software update instructions carefully. The upgrade file should not be embedded in a folder on the USB.


Power cable cannot be plugged in to DYSIS Ultra

The inner circle is pressed and power cable cannot lock into DYSIS Ultra

Hold the outer circle and pull back the inner circle to connect the power cable.

25.11.2. Software messages 15 Spray Cycles have completed. Check Acetic Acid Level

Make sure that there is enough acetic acid and in the reservoir. If not, please refill the container.

All Visit Data/Images will be Discarded. Press OK to Confirm

A message shown when CANCEL is pressed after a direct DYSIS exam; by pressing OK, all data from the visit will be discarded.

An Error has been detected in the Camera/Syringe. Please contact DYSIS

When this message is displayed, DYSIS Exam is disabled; Try shutting down the device and then start it up again. If message persists, please contact DYSIS Medical.

An Error has been Detected: Code: XXXX Press OK to Shutdown

Please contact the Administrator to export logs & forward them to DYSIS Medical for investigation.

Are you sure you want to delete image? By pressing OK, the selected image will be deleted.

Due to excessive movements, no map will be calculated

There were too many micro-movements, causing failure in registration and inability to calculate the map

Failed to Export Report. Can't access Export Directory

Please check the export directory is valid and accessible through an Administrator account.

Failed to Export Report. Please Configure an Export Path in Settings

Please check the export directory is valid and accessible through an Administrator account.

It has been xx days since the Last Calibration. Please Calibrate Now

Weekly calibration is required. This message will be displayed to perform the calibration. No mapping will be available until the instrument has been calibrated.

It has been 30 days since the Acetic Acid Consumables were changed. Please Change Now

Please change the DYSIS acetic acid applicator.

No colposcopy directed biopsy sites indicated. Confirm?

This message is displayed when Show map is selected without having added any biopsy point. By pressing OK, you confirm and the map will be displayed. By pressing cancel, you have the option to add biopsies.


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No Final Prediction Selected. Please Select Prediction to continue

Please select a Final prediction from the right-side menu for the colposcopy.

No Initial Prediction Selected. Please Select Prediction to continue

Please select the Initial predication from the right-side menu for the colposcopy.

No map will be calculated. Do you still wish to Exit?

This message is displayed when STOP is selected during the mapping procedure. No map will be calculated since not enough images were recorded. For the map to be calculated, please press NO.

No Printer Currently Configured. Please contact an Administrator.

Please contact the Administrator to check the printer is accessible and DYSIS is configured for the printer.

Please Enter the Number of Months for the Colposcopy Follow Up

The option "Other" has been selected. Please indicate the number of months for the colposcopy follow up.

Please Enter the Number of Months for the Cytology Follow Up

The option "Other" has been selected. Please indicate the number of months for the cytology/HPV follow up.

Registration Failure. Not Enough Images to Calculate Map

No map will be calculated due to registration failure.

Syringe Purge has completed successfully Purge syringe was pressed through the left side menu.

There has been a problem Connection to the DICOM Server. Please Contact a System Administrator

Please contact the Administrator to check the DICOM server is accessible. No data will be sent to the PACS server until this error message is not shown upon start-up.

There has been an issue with the Configured Export Network Share. Check Network Connection

Please contact the Administrator to check the configured network path is accessible. No data will be exported to the configured network path until this message is not shown upon start-up.

There is a problem with the USB Memory Stick

Please check the USB memory stick is working properly and then plug it again. If this message is displayed again, please use another USB memory stick.

Unable to Connect to DICOM Server. Please contact System Administrator

Please contact the Administrator to check the DICOM server is accessible.

Unable to Print To Printer: xxx Please Contact an Administrator

Please contact the Administrator to check the printer is installed properly and is accessible.

Unable to Write Report To Export Directory. Please Contact an Administrator

Please contact the Administrator to check the export path is accessible.

Video has recorded for xx Minutes. Stop or continue

This message is displayed after recording a video for 4 minutes.


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You have selected to terminate the acquisition process. Are you sure?

This message is displayed after having pressed STOP during the mapping procedure. The map will be calculated since enough images were recorded.

Available to Administrators only

At Least One of Export Directory Name Buttons must be Selected

Configure at least one option for the Export Directory.

At Least One of Report Name Buttons must be Selected

Select at least one button when configuring the report name.

Backing Up...Size: xx Mb Estimated Time: xxx Seconds

While backing up is in progress, this message displays the estimated time for backup completion.

No training images found Please contact DYSIS Medical for installing the training images.

Restart Application to apply change After having changed configurations in Settings, a restart is required.

Restart Application to complete Upgrade A Software upgrade has been completed and a restart is required.

Restore and Recover Failed. Please contact DYSIS

There has been an error in restoring from a database.

Restore Completed Successfully Restoring from a backup database has been completed successfully.

Restore Failed: Could Not Open File There has been an error in restoring from a database.

The Visit You are importing has the same Visit ID and System Serial Number as an already imported visit. Visit ID and System Serial Number as an already imported visit.

Please check the database to confirm the visit you are trying to import already exists.

There has been a problem trying to Mount the Network Share. Please check the Parameters

Please check the network configuration path & press Configure Network Share to confirm the network configuration is successful.

Use a 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.


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25.12. Replacing the DYSIS Acetic Acid Applicator Please follow instructions below to replace the DYSIS acetic acid applicator.

• Press the container upwards from its bottom in order to remove it from the holder.

• Hold the container and gently pull the two sides of the T-valve from its holder until the syringe detaches from its position.

• Press the two pins on the rear end of the speculum connector rod and remove it from its mount. Follow the above steps in reverse order to place the new DYSIS acetic acid applicator.

26. Warranty, Service, Expected Service Life and Recycling

DYSIS Ultra provides a one-year manufacturer’s warranty, covering parts and labor. Customers should contact their local representative for servicing DYSIS Ultra and for information on extended service contracts. DYSIS Ultra has an expected service life (lifecycle) of 10 years from the date the system was installed. Metal parts, such as the movable base and the pole can be recycled in metal recycling facilities. Electronic components such as monitor, CPU components and imaging head modules can be recycled at specialty electronic components recycling centers.

26.1. WEEE Regulations

The WEEE Regulations 2013 (as amended), was implemented on January 1, 2014. DYSIS products are designed to ensure that all of the equipment can be dismantled and the components and materials are recoverable. All DYSIS products that are subject to the WEEE directive shipped after August 13, 2005 and are compliant with the WEEE marking requirement. Such products are marked with the “crossed-out wheelie bin” WEEE symbol (shown, below) in accordance with European Standard EN50419.

The symbol on the product or its packaging indicates this product must not be disposed with other household waste. Instead, it is the user’s responsibility to dispose of waste equipment at a designated collection point for the recycling of electrical and electronic equipment waste. The separate collection and recycling of waste equipment at the time of disposal will help conserve natural resources and ensure it is recycled in a manner which protects human health and the environment. For more information about where to drop off waste for recycling, please contact your Local Authority.

27. Contact Information DYSIS Medical Ltd Gyleview House, 3 Redheughs Rigg, Edinburgh, EH12 9DQ, UK. www.dysismedical.com Tel: +44 (0) 131 516 3944

DYSIS Medical Inc. 3001 N Rocky Point, Suite 200, Tampa, FL 33607 Phone: 844-DYSISMED

https://www.google.co.uk/imgres?imgurl=https://gwdata.cdn-anritsu.com/images/corporate/about-anritsu/common/csr/environment/weee-mark.gif?h%3D138%26w%3D113%26la%3Den-au&imgrefurl=https://www.anritsu.com/en-AU/about-anritsu/sustainability/environment/statement-of-weee-and-rohs&docid=DScEOrCMamDS8M&tbnid=kco6yD8QhKgRuM:&vet=1&w=113&h=138&bih=598&biw=1301&ved=0ahUKEwjQkdSP4OrVAhXC7BQKHRQWDAMQxiAIGigC&iact=c&ictx=1


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28. Technical Description General Information:

• Product Name: DYSIS ULTRA

• EC Product Class: Class IIa, FDA Product Class II

Mechanical: • Monitor Arm (ARMD) - 5 degrees of freedom (X, Y, Z, tilt and yaw)

• Optical Head Arm (ARMO) - 5 degrees of freedom (X, Y, Z, tilt and yaw)

• Main Stand with 6 axis wheelbase (BASE)

PC Unit and Monitor: • DYSIS proprietary software running on Linux operating system • Motherboard: 8th Generation core i3 CPU; on-board GPU • RAM: 8GB, HDD:1 Tb, SSD:256Gb • 1 x USB port • 1 x HDMI port • 1 x Ethernet port • Monitor - 15” touchscreen monitor Full HD 1920x1080P pixels max resolution @ 60Hz, IP54 compliant front panel (IP52 housing)

Optical Head Imaging Head Unit: • CMOS sensor • Resolution: 2800 x 2100 pixels, 21 frames per second (able to differentiate 20-line pairs per mm) • Digital interface: USB3

DYSIS ULTRA Power/Operation: • Frequency: 50/60Hz

• Rated Input Voltage: 100- 240VAC • Rated Output: 12VDC

• Start Up Time to Operation < 1 min

• Operational Footprint Length, Width, Height (cm): 125 x 70 x 165

• Idle Footprint - Length, Width, Height (cm): 70 x 70 x 165

• DYSIS shipping weight (kg): 67 (Plus packaging 80Kg)

Each DYSIS ULTRA system is accompanied by:

• DYSIS Acetic acid applicator

• DYSIS declaration of conformity, EUR

• DYSIS V4 IFU

• DYSIS calibration card

• DYSIS calibration jig


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Appendix 1: ADMINISTRATOR SETTINGS

Settings In the SETTINGS menu, DYSIS Ultra can be configured according to local requirements. Activities include exporting individual cases or the entire database to a remote server, SCREEN LOCKOUT and other functions. Access to the settings functions are via an Administrator password only. To enter the SETTINGS menu, log in

and select the symbol in the top left corner of the HOME MENU and select SETTINGS from the side panel. A description of each section of the SETTINGS menu is outlined in the following section.

i. Connectivity The CONNECTIVITY tab allows DYSIS Ultra to be connected to an external server to back up and download 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 ARE NOT NETWORKED, IT IS ESSENTIAL TO BACK-UP DYSIS ULTRA DATA ON A REGULAR BASIS. FAILURE TO DO

SO COULD RESULT IN LOST DATA. DYSIS MEDICAL DOES NOT ACCEPT RESPONSIBILITY FOR LOST DATA. Back up can be carried out in several ways. Please ask your DYSIS representative to discuss options to back up via a network. By selecting the CONNECTIVITY Tab and entering the IP Netmask and Gateway, DYSIS Ultra can be connected to an external Ethernet system. Select if this occurs AUTOMATICALLY or MANUALLY when a visit is completed. The user can choose whether to only export the PDF Report or the entire VISIT which is exported by entering the folder address of the Ethernet site. After setting up the connectivity tab under settings, please take a photo of the CONNECTIVITY screenshot and email the image to [email protected] for future assistance and reference.

mailto:[email protected]


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ii. System The SYSTEM section allows the user to select language, format date and time and whether to automatically video biopsy selections (enabling this will reduce memory capacity based upon to the number of DYSIS colposcopies saved on the device), setting EXPORT of cases to an external server and IMPORT VISITs from another DYSIS. In addition, the user can export LOG FILES for routine maintenance or to assist with remote repair. DYSIS Ultra also offers the option to BACK UP and RESTORE data. This should only be carried out under the supervision of a DYSIS representative.

BACK UP can be achieved by inserting a USB Stick which has been formatted and is otherwise empty, into the USB Port of the back of the CPU denoted by the USB Symbol on the base of DYSIS Ultra or through a pre-configured export network path. Training on these functions will be given by DYSIS personnel upon installation. Through the SETTINGS tab, a BACK UP option is available. An export path should be configured so DYSIS will prompt recognition of the USB stick. By selecting BACK UP, all files will be saved as a BACK UP only which is encrypted and only readable from DYSIS software, not in a patient visit format.

iii. Password and User tabs The PASSWORD function allows individual users to manage their own login and passwords. Users with Restricted or Unrestricted roles can manage their own passwords.


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Users with ADMIN access are able to manage passwords for all staff via the USERS tab, change access levels and delete existing users as well as add new users. ADMIN Users will have access to the SETTINGS menu as well as view VISITS which have been anonymized. Unrestricted users will have access to all PATIENT VISITS and records Restricted users will only be able to access cases carried out using their own USER LOG IN.

The DYSIS representative will assist with setting passwords upon installation.


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User names and passwords are case sensitive and passwords need to be five characters or more. Please enter information in all fields shown, LOG IN NAME, REAL NAME and PASSWORD to create new users. When setting up new users, a default password is applied. With the first log in, the new user is prompted to change their password.

iv. Export Using the ADMIN access log in, the EXPORT tab allows the user to add a printer, add a logo and configure the appearance of the PDF report which can be printed or exported from each patient record. The user can choose to include FIRST and LAST NAMES, PATIENT ID and VISIT DATE in the report by selecting the appropriate boxes. In addition, the user can configure the details included in each report in the EXPORTED reports which is saved in the back-up files as the EXPORTED DIRECTORY NAME.

a. Adding a printer Prior to adding a printer, please use the following link to check the desired printer is compatible with the DYSIS Ultra: http://www.openprinting.org/printers/ If so, proceed with the following steps or follow the instructions found on the above link. Press the Add new printer button. By pressing this button, the following popup window is displayed.

http://www.openprinting.org/printers/


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As described in the popup message, visit the webpage which was displayed. The user will have access to the printer configuration webpage (see below); a username & password will be requested (username: printer / password: printer)

Go to the Administration tab, as shown below and press Add Printer under the Printers section

The following screen will appear:


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To install a network printer, select the LPD/LPR Host or Printer option and then select Continue. Enter the IP address of the network printer along with its shared name (see example below) and select Continue.


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Add a name and select Continue.

Select the printer manufacturer (Make field) and Select the model, then select Add Printer.


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When instructed, select default options.


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After receiving a successful installation message, the printer will be displayed in the Printers tab

From the dropdown menu under Maintenance, select Print test page to verify the printer was successfully installed. Now the installed printer will be available to DYSIS Ultra (through Settings, tab Export).

v. EMR The EMR Tab is only available to DYSIS personnel and DYSIS Administrators.


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The EMR tab enables the user to allow DYSIS Ultra to interface with an EMR system in order to download patient demographic details or clinic appointments.

a. DICOM Storage To Configure the DYSIS Ultra to send and store images to a PACS system, the following settings should be applied: Local AE Title: DYSIS_COLPOSCOPE Storage: Enabled AE Title: DYSIS_PACS Address: IP Address (the IP address of the PACS server) Port: 11112 Click “Check Connection” To make sure it is operational. After a new exam has been performed, all Images will then be sent to the PACS system.

b. Modality worklist To configure DYSIS Ultra system to use modality worklists, the following setting should be applied: Local AE Title: DYSIS_COLPOSCOPE MWL: Enabled AE Title: DYSIS_PACS Address: IP Address (the IP address of the PACS server) Port: 11112 To add an Item to the Modality Worklist for DYSIS Ultra, an ORM^001 (Order Request Message) should be sent to the DYSIS_PACS.


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c. HL7 (adding appointments & patient demographics retrieval) To add appointments to DYSIS Ultra, the following settings should be applied:

Send an email request to [email protected] to receive an HL7 channel “Add appointment”. Add this appointment to Mirth, accessible at DYSIS Ultra (IP Address http://x.x.x.x:8080). The IP address is located under the Connectivity tab, under network IP. In Settings, select EMR then select Enable New Appointments When aforementioned channel is added and deployed, a new button named Today’s appointments will appear under the Patient Database. By selecting this, only today’s appointment will be listed. In order to switch between the entire patient database and today’s appointment list, select the corresponding button.

To query a patient ID, the following settings should be applied: Send an email request to [email protected] to receive two HL7 channels “Query” and “Response”. Add to Mirth, accessible at (DYSIS IP Address http://x.x.x.x:8080) The IP address is located under the Connectivity tab, under network IP. Under the Settings tab: select EMR, Enable Query When the aforementioned settings have been applied, a new Query button is now available under the Patient Database. By selecting, a popup window will appear. Enter the required Patient ID and click Query to retrieve patient demographics.


http://x.x.x.x:8080/


http://x.x.x.x:8080/


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Appendix 2: 60601-1-2 DATA Tables of guidance and manufacturer’s declaration regarding electromagnetic emissions and immunity as per by EN 60601-1-2:2015. Data extracted from Eurofins York EMC Test Report 5104TC2.

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

At 230V 50Hz and 110V 60Hz

Pass

Radiated RF emission (Enclosure)

EN55011:2009+ A1:2010


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


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


3V/m

80-2700MHz

Mode 1

Pass

Proximity fields from RF wireless communications equipment

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


As detailed below and in section 8.10 of standard

Mode 1

Pass


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EN60601-1-2: 2015




Test frequency

Band Service Modulation Maximum Power

Distance Immunity Test Level

(MHz) (MHz) (W) (m) (V/m)

385

380-390

TETRA

Pulse Modulation

18Hz

1.8

0.3

27

450

430-470

GMRS 460

FRS460

FM

5kHz deviation

1kHz sinewave

2

0.3

28

710

704-787

LTE Band 13, 17

Pulse 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, 3, 4, 25; UMTS

Pulse Modulation

217Hz

2

0.3

28 1845

1970

2450

2400-2570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE

Band 7

Pulse Modulation

217Hz

2

0.3

28

5240

5100-5800

WLAN 802.11 a/n

Pulse Modulation

217Hz

0.2

0.3

9 5500

5785

RATED power frequency magnetic fields

EN 61000-4-8:2010


30A/m

No magnetically sensitive parts

N/A

Input a.c. power Port (Table 5 – Page 35)

Electrical Fast Transients / Bursts

EN61000-4-4:2012


2kV

100kHz repetition frequency

Mode 1

Pass

Surges

EN61000-4-5:2006


0.5 and 1kV line to line

0.5, 1 and 2kV line to earth

Mode 1

Pass


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EN60601-1-2: 2015




Conducted disturbances induced by RF fields 3Vrms Pass

EN 61000-4-6: 2014 0.15-80MHz

Referenced in Table 5 (Page 35) 6Vrms in ISM bands between 0.15MHz and 80MHz.

The ISM (industrial, scientific and medical) bands between 0.15MHz and 80MHz are 6.765MHz to 6.795 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


at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0 % UT; 1 cycle

and

70 % UT; 25/30 cycles

Single phase: at 0°

0 % UT; 250/300 cycle

Mode 1

230V and 100V

Input DC Power Port (Table 6 – Page 37)


EN61000-4-4:2012


2kV


No DC port

N/A

Surges

EN61000-4-5:2006




No DC port

N/A

Conducted disturbances induced by RF fields 3Vrms N/A

EN 61000-4-6: 2014 0.15-80MHz

Referenced in Table 6 (Page 37) 6Vrms in ISM bands between 0.15MHz and 80MHz.

No DC port

Electrical Transient conduction along supply lines

ISO7637-2

Not applicable N/A

Patient coupling port (Table 7 – Page 38)


EN61000-4-2: 2009


2, 4, 8, 15kV air


No patient coupling port

N/A


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EN60601-1-2: 2015




Conducted disturbances induced by RF fields

EN 61000-4-6: 2014


3Vrms

0.15-80MHz

6Vrms in ISM bands between 0.15MHz and 80MHz.

No patient coupling port

N/A

Signal input/output parts Port (Table 8 – Page 39)


EN61000-4-2: 2009


2, 4, 8, 15kV air


Mode 1

Pass


EN61000-4-4:2012


1kV


Mode 1

Pass

Surges

EN61000-4-5:2006


This test applies only to output lines intended to connect directly to outdoor cables



No outdoor cables

N/A

Conducted disturbances induced by RF fields

EN 61000-4-6: 2014


3Vrms

0.15-80MHz

6Vrms in ISM bands between 0.15MHz and 80MHz.

The ISM (industrial, scientific and medical) bands between 0.15MHz and 80MHz are 6.765MHz to 6.795 MHz; 13.553MHz to 13.567MHz; 26.957MHz to 27.283MHz; and 40.66MHz to 40.70MHz

Mode 1

Pass

Documents

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use · DYSIS Ultra 2.0 Digital Colposcope Instructions for Use – (US) 0330-53095 R1 Page 7 of 77 Use only cabling supplied or