DYSIS Ultra 2.0 Digital Colposcope Instructions for Use · 0230-53095 R1 Page 8 of 78 If the device...

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095 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-Colour 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. Optical 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. List of Accessories ............................................................................................................ 17 13. Powering on the DYSIS ULTRA ......................................................................................... 18 14. Powering Off the 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 ............................................................................................. 22 18.4. Creating a New Patient Record ....................................................................................... 22 18.5. New Visit for an Existing Patient ..................................................................................... 24 19. DYSIS Examination Preparation and Functions ............................................................... 25 19.1. Adding data to a Patient visit record ............................................................................... 25 19.2. Using DYSIS to perform examination of the Lower Genital Tract without mapping ....... 26 19.3. Assigning a visit after a DYSIS Exam from Home screen.................................................. 28 19.4. Using DYSIS ULTRA to carry out a standard colposcopic examination ............................ 28 19.5. Preparing the patient ...................................................................................................... 29 19.6. Additional Options ........................................................................................................... 31 20. Starting the DYSIS Exam .................................................................................................. 31 20.1. Using DYSIS ULTRA IN TRIAL mode .................................................................................. 35 20.2. The DYSIS Map ................................................................................................................. 38 20.3. Dynamic curves ............................................................................................................... 39 20.4. Adding additional biopsy markers ................................................................................... 40 20.5. Biopsy point viewing ....................................................................................................... 40 20.6. Exiting the Exam .............................................................................................................. 40 21. Additional information post colposcopic examination ................................................... 41 22. Patient Database ............................................................................................................. 44 22.1. Reviewing a visit .............................................................................................................. 44 22.2. Visit History ..................................................................................................................... 46


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22.3. SMARTtrack ..................................................................................................................... 47 23. Downloading or Printing a Report ................................................................................... 49 24. Additional Functions ....................................................................................................... 50 24.1. Info .................................................................................................................................. 50 24.2. Password tab ................................................................................................................... 50 25. Care, Maintenance and Troubleshooting ........................................................................ 51 25.1. General ............................................................................................................................ 51 25.2. Replacement of Parts ...................................................................................................... 51 25.3. ARM, BASE and Computer Housing Cleaning .................................................................. 51 25.4. Touchscreen Monitor Cleaning ....................................................................................... 52 25.5. Optical Head Cleaning ..................................................................................................... 52 25.6. Disinfection ..................................................................................................................... 52 25.7. DYSIS Specula .................................................................................................................. 53 25.8. DYSIS Acetic Acid Applicator ........................................................................................... 54 25.9. Periodic Cleaning and Maintenance................................................................................ 54 25.10. Routine Electrical Testing ................................................................................................ 54 25.11. Troubleshooting .............................................................................................................. 54 25.11.1. Troubleshooting guide .................................................................................................... 55 25.11.2. Software messages.......................................................................................................... 56 25.12. Replacing the DYSIS Acetic acid applicator ..................................................................... 58 26. Warranty, Service, Expected Service Life and Recycling ................................................. 59 26.1. WEEE Regulations ........................................................................................................... 59 27. Contact Information ........................................................................................................ 60 28. Technical Description ...................................................................................................... 61 Appendix 1: ADMINISTRATORS SETTINGS ..................................................................................... 62 Α. Calibration of the System .......................................................................................................... 62 Β. Settings ...................................................................................................................................... 64 i. Connectivity .................................................................................................................... 64 ii. System ............................................................................................................................. 65 iii. Password and User tabs .................................................................................................. 65 iv. Export .............................................................................................................................. 67 a. Adding a printer .............................................................................................................. 67 v. EMR ................................................................................................................................. 71 a. DICOM Storage ................................................................................................................ 72 b. Modality worklist ............................................................................................................ 72 c. HL7 (adding appointments & patient demographics retrieval) ...................................... 72 Appendix 2: 60601-1-2 DATA ........................................................................................................ 75


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1. Applicable Standards Refer to Declaration of Conformity for a list of the standards and guidelines which 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 minimise 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. The 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 systems

3. Indications for Use DYSIS with Pseudo-Colour 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 affirm normality 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-Colour 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-Colour Imaging (PCI).

4. Optimal Use of the Pseudo-Colour 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-colour overlay Map. During the Dynamic Imaging procedure, which is used to generate a pseudo-colour 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 that 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 summarises 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 minimise 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 that it is in optimal use condition, 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 touch and patient screens are folded above the CPU, and the optical head arm is fastened by its magnetized catch. Never use your hands to engage or release the foot brake. Before moving DYSIS ULTRA, make sure that the foot brake has been released and the wheels have been lowered. Always engage the foot brake before an examination. DYSIS ULTRA should be positioned on a flat floor and the foot brake engaged to prevent movement and toppling. Connect only accessories that are specified in this guide as part of DYSIS ULTRA or that have been specified as being compatible with DYSIS ULTRA. To avoid the risk of electric shock, DYSIS ULTRA must only be connected to a power supply with protective grounding. Never attach the DYSIS speculum to the optical head before inserting it into the vagina. Do not apply any force on top of the optical head during an examination or at any other time (especially if a DYSIS speculum is connected). 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 side panel. DYSIS ULTRA will shut down automatically.

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

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


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If the device is accidentally contaminated during an exam, use only indicated disinfecting solution to cleanse it. Before attempting this disinfecting action, the device needs to be powered down and the power cables should be disconnected. Wear the correct 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 optical 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 user/patient injury. To ensure optimal operation and safety, users should not remove any of the connectors on DYSIS ULTRA. When using the DYSIS 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 DYSISmapTM is not meant to replace conventional colposcopic assessment and decisions regarding biopsy 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 of them. When using different concentrations of acetic acid, the acetowhitening characteristics may change and consequently the correspondence of the DYSISmap colour coding to certain degrees of acetowhitening.

(This Consultation Symbol Applies to Consultations Below) When adjusting the image brightness, the practitioner should ensure viewing the monitor directly and not from the side or from below, as this may distort the perception of the colour 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 minimised. 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 the marking.


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Access to the database is restricted for unregistered users. The “Required” marked 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 the DYSIS ULTRA instrument 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 optical head


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5.1. Location of Labels The product label (containing the device name, serial number, DYSIS ULTRA legal manufacturer address, Unique Device Identifier Barcode) and the warning labels are located on the back of the PC enclosure. Product and warning labels included on each device as per examples below:

Product Label - containing the device name, serial number, DYSIS ULTRA 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 The 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 Optical Head is not an applied part but could accidentally come in contact with the patient. The optical head and the positioning arm are protected by double insulation that prevents the patient 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 0°C and 50°C (32°F to 122°F) and humidity up to 95% (non- condensing).

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

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

7.4. Atmospheric Pressure There is no impact of 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 ULTRA 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; 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 ULTRA other than the DYSIS Acetic acid applicator and the fuses; DYSIS Acetic acid applicator (ACE004) is recommended to be replaced every 30 days. Apart from the speculum and smoke extractor extension, 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 ULTRA); do not push or pull DYSIS ULTRA in a way other than the way 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 Optical Head 3 - Optical 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 down the green pedal with your foot. When in a suitable position, the red switch on the pedal should be pressed to engage the brake. Do not use your hands to engage the brake.

9.2. ARMS To place the DYSIS ULTRA in the most suitable position for use, both arms can be easily adjusted. It requires minimal effort for repositioning and they are not required to be locked in position. When opening the arms, support must be given to the optical 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 optical head ‘falling’ a little way, 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. Optical Head The optical head consists of a camera with LED lighting and DYSIS acetic acid applicator system. The speculum is also attached to the optical head using the speculum connector.

9.4.1. Camera and Light The camera within the optical 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: As the optical head emits radiation (wavelength 440 to 633nm, widely divergent and with maximum average power of 7.4mW), it is imperative that 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 optical head. (See Section 25.12 for changing the DYSIS Acetic Acid Applicator).

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

10. Power cord and Power On/Off The DYSIS ULTRA unit should only be used with the supplied AC/DC PSU.

The DYSIS ULTRA system should be isolated from the mains supply by switching the unit off.

11. Assembling and inserting the power cord Insert the end of the power cord into the PSU. 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 the 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. List of Accessories The following accessories are supplied with the instrument: - DYSIS Acetic Acid Applicator - Disposable Speculum – class I sterile - Reusable Speculum – class I - Treatment pipe


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13. Powering on the DYSIS ULTRA To power on the 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 the DYSIS ULTRA To turn off the DYSIS ULTRA, press SHUTDOWN from the left panel of HOME screen or from the LOGIN screen, and wait for the DYSIS to shut down. DO NOT SWITCH THE DYSIS ULTRA OFF BY CUTTING THE POWER OR OPERATING THE POWER SWITCH UNTIL IT HAS SHUT DOWN 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 analyses synchronised still images of acetic acid application to present a colour-map overlay intended to help clinicians visualise aceto-whitened areas of the cervix. Use of the DYSISmap feature is NOT a substitute for the conventional colposcopic view. When using DYSIS ULTRA with DYSISmap, you must ALWAYS first conduct a thorough colposcopic examination and identify and select areas for biopsy. You may then use the DYSISmap feature to identify, where appropriate, one or more additional biopsy sites. NEVER cancel any of the biopsy sites initially identified with the conventional colposcopic view. The software embedded in DYSIS ULTRA has been designed to ensure that you are able to comply with this requirement when using DYSIS ULTRA in ‘TRIAL’ mode. Therefore, the examination process will proceed as follows:

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


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Insert initial prediction Observe DYSISmap Selection of additional biopsy points Take all selected biopsies and label appropriately Insert final prediction

When not using DYSISmap in TRIAL mode the steps will be as follows; Examination preparation Initiate DYSISmap procedure Colposcopic examination (including application of acetic acid to observe acetowhitening effect) Observe DYSISmap Selection of biopsy points and label appropriately Take all selected biopsies

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

16. DYSIS Acetic Acid Applicator Kit

The DYSIS Acetic acid applicator assembly is filled by removing the bottle from its holder, unscrewing the lid and filling to 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 how to change the DYSIS acetic acid applicator, a warning message will be displayed every 30 days prompting the change.

17. Positioning for an examination To position DYSIS ULTRA next to the couch ready for operation considerations to be taken into account are:

• Space available

• Position of power points

• Left or right-handed operator

• Type of examination couch


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Ideally the DYSIS ULTRA should be positioned next to the couch 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 the team in order to be able to disengage and move it easily should the patient require emergency treatment at any time.

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 username and password (default usernames and passwords are provided upon installation as per 0231-84058 (Installation Checklist) and can then be then customised). After completing the requested information, the user has to press LOGIN to enter the Home menu where it is possible 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 touching any of the soft touch buttons.

As well as the home menu, other options are available by selecting the icon on the upper left corner, which expands a side panel with additional function. From this expanded panel, the user can use simulator to be trained on simulation cases, PURGE the DYSIS acetic acid applicator, change SETTINGS to set or change the device accessibility, press HELP, export all data to export a csv file, LOG OUT to log out of the application and SHUT DOWN to terminate operation.


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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 (such as during mapping)

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

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.

18.4. Creating a New Patient Record To create a record for a new patient, the DYSIS ULTRA user must 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 its 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 on pressing SAVE


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18.5. New Visit for an Existing Patient To create a NEW VISIT for an existing patient, first select the patient from the database by entering PATIENT DATABASE from the home menu and selecting the patient by either 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, NEW VISIT from the boxes highlighted at the bottom right of the screen. A NEW VISIT record will be presented. Information on the NEW VISIT can be entered in the same way as described in section 19.1

Having highlighted the patient, 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 examination of the Lower Genital Tract without mapping

To use DYSIS ULTRA to carry out examination of the Lower Genital Tract first create A NEW PATIENT record as described in section 18.4, or adding to an existing patient record as described in 18.5. Then press DYSIS EXAM.


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Alternatively Press DYSIS EXAM from the Home screen, the camera and light will be switched on automatically. Assign any saved images following the examination to a patient record following the procedure in section 19.3.

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-hand side menu of the

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

This allows the user to save individual still images which can be annotated when the on-screen keyboard appears 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 the green filtered light of the colour image. To deactivate press the button again.

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

Option to enable/disable the polarisers

In order to exit and save the images/videos, press the button from the upper left corner and select

or simply press .


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19.3. Assigning a visit after a DYSIS Exam from Home screen After saving images, videos or having performed an examination, by exiting the DYSIS exam screen the following screen appears:

The user can either create a new patient to whom 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.

19.4. Using DYSIS ULTRA to carry out a standard colposcopic examination The practitioner can start an examination by selecting DYSIS EXAM either from the home menu (without entering patient information), or after initiating a new visit of a specific patient (see section 18.5 above) or by creating a NEW PATIENT record (see section 18.4 above). When the examination is initiated from the home menu, the practitioner 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 optical head is automatically turned on and the camera and light are operational. The Clinician can observe the image in the field of view of the camera on the touch screen in order to perform a standard colposcopic examination.


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19.5. Preparing the patient Follow standard clinical practice to insert the speculum. Adjust the speculum to achieve the optimal field of view. Gently clear 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 ULTRA can be connected to the speculum via the connecting rod at the front of the optical head after insertion to stabilise the image during the examination. It is connected by pushing the end of the speculum connecting rod into the opening on the green connector from the Optical head. This does not lock into place but will stabilise the image whilst the examination takes place.

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.

Examination Screen


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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 annotated 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 the green filtered light of the colour 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

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

Start Opens the examination options

Polarisers ON/OFF

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

Back button

Exiting the Examination; an option to save the acquired data will be displayed

Additional options

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


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19.6. Additional Options

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

Examination Screen (with left side menu shown)

Shows Saved images

Displays images that were taken and saved

Cancel Exam Cancels the examination

20. Starting the DYSIS Exam

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


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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

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.


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During the mapping process, a thorough colposcopic examination should be completed by the clinician. 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 clicking on the camera button; a dialog box with an image preview and a keyboard on the touch screen 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 data storage, to a network folder or printed.

Examination Screen (during mapping) During the examination, a timer will display in the right corner of the touchscreen. It requires at least 130 seconds of information for the map to be calculated and will automatically stop at 185 seconds. The


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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. After approximately 130 seconds the timer will turn green after which a map will be calculated if STOP is selected. A message will be displayed asking if you wish to terminate the process and must be acknowledged for the process to be halted.

When using DYSIS ULTRA, at any moment during dynamic Imaging, the user can review the images that have been captured thus far, by clicking on the playback icon. The playback can be accessed by clicking on the

button at the bottom of the screen in live viewing. A set of controls are accessed that allow the user to advance the images at 2x normal speed, 5 x normal speed and individually. 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 live view.

Examination Screen (with the exam playback panel shown) After the examination, brightness, focus adjustments, button for enabling/disabling polarization view and video recording will be available again.


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Additional options will be added to the right menu.

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 response to the acetic acid

20.1. Using DYSIS ULTRA IN TRIAL mode

When using DYSIS ULTRA in TRIAL Mode the user will follow the steps as above. Some additional information is required. The Colposcopist will, using the BIOPSY selection buttons, mark up to 5 biopsy sites where they would take a biopsy during a standard colposcopic examination. An extra button is available in this mode, allowing the user to add their impression.

Initial prediction

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


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Examination Screen (on trial mode – button to add prediction visible) Prior to viewing the map, the user must insert their impression – either NORMAL, LOW or HIGH according to their observations, a warning message will be displayed if this step has not been completed.

On displaying the map, preselected biopsy points are shown in bright blue colour. The Colposcopist would then mark any additional areas of interest highlighted by the map. See section 20.4. All biopsies should be gathered and labelled appropriately. After viewing the map, the initial prediction button is turned into final prediction. The colposcopist might then enter their final prediction. Prior to closing the exam, the final impression should be entered, a warning message will be displayed if this step has not been completed.


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20.2. The DYSIS Map

Examination Screen (DYSISmap ON) DYSIS ULTRA will document the dynamic optical phenomena associated with the acetowhitening effect in a colour-coded map (DYSISmap). DYSIS ULTRA allows the capturing of a sequence of images at high-resolution. The images are automatically aligned to compensate for tissue micro-movements and are then 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 colour-coded map but viewing the DYSISmap should never lead to the cancellation of biopsy sites selected during the normal colposcopic exam. The DYSISmap captures and documents the tissue acetowhitening dynamics (intensity over time). The continuum of colours 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 colour code used to document the tissue acetowhitening dynamics as depicted by DYSIS ULTRA. This colour assignment is based on the intensity and duration of acetowhitening over the period of the dynamic imaging procedure.


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Colour coding Whitening White

Intense Yellow

Red Strong Green Dark blue Weak

Cyan Very Weak

No Colour Very weak/ None

20.3. 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 part of the display (but can be moved around the screen to a convenient location), where the vertical axis represents the acetowhitening intensity and the horizontal axis represents the time since application of acetic acid.

Examination Screen (DYSISmap & graph 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 tool is available during acetowhitening when Ultra is being used. When TRIAL mode is switched on this function is only available after the map has been calculated and viewed.


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20.4. Adding additional biopsy markers

Additional biopsy markers can be added after the map has been displayed by selecting buttons. The biopsy markers which were added prior to the map will be displayed in bright blue and those chosen after the map will be orange. Up to 5 biopsy markers can be added.

20.5. Biopsy point viewing In order to assist the biopsy procedure, the “Hide Map” button can be pressed and the DYSISmap will be removed from view, leaving the biopsy points visible on the live image of the cervix.

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 marked.

20.6. 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.


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21. Additional information post colposcopic examination Information of 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 and the keyboard

COLPOSCOPY: Colposcopic findings after the examination. The COLPOSCOPY screen will be automatically displayed after the live image screen is exited.


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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 which can be typed in by using the on-screen keyboard.


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

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

Will allow the user to freehand draw on the DYSIS ULTRA touchscreen

Allows the user to view the customised visit report

Exports the entire individual visit to a USB or Ethernet connection (please see Appendix 1 Bi connectivity below)

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 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 Visit.

To search the PATIENT DATABASE the user can click on either the LAST NAME, FIRST NAME, PATIENT ID and LAST VISIT Tabs which will order visits alphabetically and numerically in that column.


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Alternatively, by tapping 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 their list of visits in the right-hand summary of the patient record.

OPEN in the top right-hand corner will open a more detailed copy of the patient’s record and visits. Highlighting a specific visit will allow the user to view that patient visit record and the patient 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 can add HISTOLOGY RESULTS after the visit.

Exam Playback screen (reviewing a visit) Even while reviewing an old visit, there is an option to apply filters and save additional images.

An additional button is available when reviewing the aligned images when a map is available. By pressing it, the colour distribution of the map will be presented.

22.2. Visit History The DYSIS patient records can be amended after a visit at any time and those 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 changed entry. It can then be confirmed or discarded.


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

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 that you want 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 centre line, illustrating the amount of reduction in each colour. If the aceto-white response is greater between the two visits, the graph will show a positive value above the centre 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 reported on. Select individual images from the row at the bottom of the screen by pressing the INCLUDE IN REPORT box then select REVIEW REPORT. Images that have been captured independent of the mapping process by the operator will be automatically included in the report. To deselect these images, press the X button to grey out the image and eliminate it 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.


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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 if desired.

24. Additional Functions In the SETTINGS menu the 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 of the DYSIS ULTRA. Access to the settings functions are via an Administrator password only, which can be set by your DYSIS

representative on 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: ADMINISTRATORS SETTINGS.

24.1. Info The INFO tab will show the software version in use for example 1.0.11. In addition, serial numbers of components such as the camera are displayed. It will be important to know this information when reporting faults 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 though Password tab


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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. User names and passwords are case sensitive, 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.

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 ULTRA and turning off and unplugging DYSIS ULTRA from the mains power outlet Do not immerse any part of DYSIS Ultra into cleaning solutions

When not in use the DYSIS ULTRA should be stored with lower arm folded against itself, utilising the magnet at the top of the arm to ensure arm is locked in place. The upper arm should be folded back on itself in an upright position, with the monitor over the base. This will ensure when the DYSIS ULTRA is moved the monitor and optical head are protected. When moving the DYSIS ULTRA the user should release the footbrake, push the metal stand but not push the DYSIS ULTRA by placing hands on the arms, optical head or monitor. Care should be taken to protect exposed parts when manoeuvring.

25.2. Replacement of Parts All parts of DYSIS ULTRA colposcope are replaceable and this operation will be performed by DYSIS Medical representatives. Circuit diagrams are available from DYSIS Medical representatives on 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


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Ensure there is no ingress of fluid into connection ports, switches and buttons. Cleaning of the monitor touchscreen and optical head are dealt with separately

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

25.5. Optical Head Cleaning The optical 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 optical 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.

25.6. Disinfection

If needed the 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 Colposcopes Cleaning and Maintenance Instructions.


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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 applicator kit does not come into contact with the patient at any time. The applicator kit should be purged with acetic acid prior to use. The acetic acid solution should be labelled and discarded/changed per facility protocol. If daily or periodic cleaning is required per facility protocol and is not required to be a sterile solution, the acetic acid solution can be poured out of the acetic acid reservoir and the reservoir rinsed and dried. To rinse the tubing, pour 10 ml of water into the reservoir. The tubing can be flushed by pulling back and depressing the syringe while holding a paper towel in front of the diffuser. The bottle should be removed and dried, the tubing should be dried by depressing the syringe several times to expel any remaining fluid. The DYSIS Acetic acid applicator should be replaced every 30 days (please see section 25.12). The DYSIS acetic acid applicator consists of the syringe, the acetic acid reservoir, the luer lock, the spray nozzle and the silicon tubing. If the local clinical practice is to store and maintain acetic acid in sterile conditions, it is strongly recommended that the kit is high level disinfected before use. This can be achieved by using a commercial high-level disinfection fluid, which should be used according to the manufacturer’s instructions. Ensure that the sterilisation liquid reaches all parts of the kit, by filling the reservoir with the high-level disinfection liquid and then draw and press the syringe plunger to fill the tubing (repeat until the tubing is filled and liquid is sprayed from the nozzle). Purge the high-level disinfection fluid from the applicator by repeating these steps using sterile saline or sterile water until cleared according to manufacturer’s instructions for rinsing. It is not possible to sterilise the acetic acid applicator kit.

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

25.10. Routine Electrical Testing

The DYSIS ULTRA system can be split into 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 ULTRA 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 the identification and the solution of the problem. Before performing any troubleshooting action, please make sure that the power cord is connected and note if the indicator light in the rear of the main unit is alight.

https://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwj289CL2abVAhVGbBoKHa76D20QjRwIBw&url=https://commons.wikimedia.org/wiki/File:Double_insulation_symbol.svg&psig=AFQjCNHEInlBli8R9KtynnuKSVZpuMIXaA&ust=1501149843688696


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The following table lists specific issues that may be experienced with DYSIS ULTRA. Observe all safety precautions and warnings and make sure you read carefully and fully understand the instructions for use before attempting any of the troubleshooting below. Make sure you shut down, disconnect from mains power and restart the unit before contacting technical support. If any of the suggested actions fail to solve the problem, please contact the DYSIS Medical service department.

25.11.1. Troubleshooting guide

Description Possible Cause(s) user Action

The optical head does not maintain its position

Arm not enough extended Make sure that the arm is extended enough so that it is in the “V” position

Image is fuzzy, unclear or dark Optical head lens may be very 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

ULTRA’s 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.

Contact service to reconfigure system to UK settings

Image is displayed, but illumination does not turn on

Illumination source malfunction


DYSIS ULTRA 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 with the locking at the

DYSIS ULTRA 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 in which 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 on DYSIS ULTRA

Hold the outer circle and pull back the inner circle

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

Make sure that there is enough acetic acid & 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 of 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 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 through an administrator account that the export directory is valid and accessible.

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

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

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

When a weekly calibration is required, this message will be displayed in order to perform the calibration. Until a successful calibration is completed, no mapping procedure will be available

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?

Having pressed Show map without having added any biopsy point. By pressing OK you confirm and get the MAP, by pressing cancel you have the option to add the directed biopsies.


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No Final Prediction Selected. Please Select Prediction to continue

Please press the Final prediction button from the right-side menu & select the relative value

No Initial Prediction Selected. Please Select Prediction to continue

Please press the Initial prediction button from the right-side menu & select the relative value

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

This message is displayed after having pressed STOP 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 that the printer is accessible.

Please Enter the Number of Months for the Colposcopy Follow Up

The option "Other" has been selected, so 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, so please indicate the number of months for the cytology 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 that the DICOM server is accessible; No data will be sent to PACS server until this error message is not shown at start-up.

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

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

There is a problem with the USB Memory Stick

Please check the USB memory stick that is working properly and then plug it again; if this message is prompted again, please use another USB memory stick.

Unable to Connect to DICOM Server. Please contact System Administrator

Please contact the administrator to check that the DICOM server is accessible.

Unable to Print To Printer: xxx Please Contact an Administrator

Please contact the administrator to check that 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 that 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

Make sure you will configure at least one option of Export Directory.

At Least One of Report Name Buttons must be Selected

Make sure you will 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 that 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 again the network configuration path & press Configure Network Share to confirm that 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.

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

• Press the container from its bottom upwards, 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 will be able to be detached from its position.

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


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26. Warranty, Service, Expected Service Life and Recycling

DYSIS ULTRA is offered with a one-year full warranty, covering parts and labour. Customers should contact their local representative for servicing DYSIS ULTRA and for information on service contracts. DYSIS ULTRA has an expected service life (lifecycle) of 10 years from the date that the system was shipped to the customer. 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 stores.

26.1. WEEE Regulations

The WEEE Regulations 2013 (as amended), came into force from 1st January 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 from 13th August 2005 are compliant with the WEEE marking requirement. Such products are marked with the “crossed-out wheelie bin” WEEE symbol (shown, right) in accordance with European Standard EN50419.

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

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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27. Contact Information

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


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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


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Appendix 1: ADMINISTRATORS SETTINGS

Α. Calibration of the System This procedure is performed only by administrators when requested. 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. CALIBRATION of the system will be available through the left panel of the HOME screen.

By pressing the calibrate button, the following screen appears:

After having pressed START, the user should follow the instructions as displayed on 3 sequential messages:


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After confirmation on above messages, the software is attempting to focus accurately and then calibrating the colours. When completed, a relevant message will be displayed. The CLOSE button should be pressed to return to the HOME screen.


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Β. Settings In the SETTINGS menu DYSIS ULTRA can be configured according to local requirements. Activities include, enabling TRIAL mode, enabling or disenabling HIPAA restrictions, exporting individual cases or the entire database to a remote server, SCREEN LOCKOUT and other functions of the DYSIS ULTRA. 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-hand corner of the HOME MENU and select SETTINGS from the side panel. A description of each section of the SETTINGS menu follows.

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 THAT A BACK-UP OF DYSIS ULTRA DATA IS CARRIED OUT 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. Through the CONNECTIVITY Tab, by entering IP Netmask and Gateway it is possible to connect DYSIS ULTRA to an external Ethernet system. It is also possible to choose whether this occurs AUTOMATICALLY or MANUALLY when a visit is completed. The user can also choose whether to only export the PDF Report or whether the whole VISIT is exported by entering the folder address of the Ethernet site. After having set up the connectivity tab of settings, please make sure you will take a photo of that screenshot in order to send it 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 of date and time and whether to automatically video biopsy selection and gathering (enabling this will reduce memory capacity in reference to the number of DYSIS colposcopies saved on the device). Setting EXPORT of cases to an external server and also IMPORT VISIT from another DYSIS. In addition, the user can carry out CALIBRATION, export LOG FILES for routine maintenance or to assist with remote 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 technician.

BACK UP can be carried out by inserting a USB Stick (that has been formatted and is otherwise empty) into the USB Port of the back of the CPU unit denoted by the USB Symbol on the base of DYSIS ULTRA or through a pre-configured export network path. Full training and advice on these functions will be given by DYSIS personnel on installation. Through the SETTINGS SYSTEM tab a BACK UP option is available. An export path should be first configured so that DYSIS will prompt recognition of the USB stick and on pressing 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 folder format.

iii. Password and User tabs The PASSWORD function allows individual users to manage their own login and passwords. Clinicians with Restricted or Unrestricted role 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 anonymised. Unrestricted clinician’s level will have access to all PATIENT VISITS and records Restricted clinician’s level will only be able to access cases carried out using their own user LOG IN.

The DYSIS team will assist staff to set passwords on installation.


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User names and passwords are case sensitive, 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. On first log in, the new user is prompted to change password.

iv. Export Using 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 that can be printed or exported from each patient record. The user can choose to include FIRST, LAST NAMES, PATIENT ID and VISIT DATE in the report by selecting the appropriate boxes. In addition, the user can configure the details included on each file in the EXPORTED reports saved in the back-up files as the EXPORTED DIRECTORY NAME.

a. Adding a printer Prior adding a printer, please use the following link to check that the printer to be installed is compatible with the DYSIS ULTRA. http://www.openprinting.org/printers/ If so, then 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 at the popup message, by visiting the webpage 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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For a network printer, select the LPD/LPR Host or Printer option and then press Continue. On the screen below, fill in the IP address of the network printer along with its shared name (see example below) and then press Continue.

On the following screen, add a name and then press Continue.

The following screen by selecting the printer’s manufacturer (Make field) and then pressing continue, an extra field to select a model appears. After having selected the model, please press Add Printer.


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When instructed, just select default options.


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After having received a successful installation message, at the Printers tab, the printer will be displayed.

On the dropdown menu where Maintenance is listed, please select Print test page to verify that the printer was successfully installed. Now the installed printer will be available to DYSIS ULTRA (through Settings, tab Export).

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


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The EMR tab enables the user to allow DYSIS ULTRA to interact with a site’s EMR system in order to download patient demographic details or clinic appointments.

a. DICOM Storage To Configure DYSIS ULTRA System to Store Images to the PACS, 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 The Click “Check Connection” To make sure everything works. After this after a New Exam has been performed all Images should be sent to the PACS.

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 Colposcope, an ORM^001 (Order Request Message) should be sent to the DYSIS_PACS.

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


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Send an enquiry at [email protected] to receive an HL7 channel “Add appointment” and then add it to Mirth, Accessible at DYSIS ULTRA IP Address http://x.x.x.x:8080 (IP shown at Connectivity tab, under network IP) On the Settings: tab EMR, Enable New Appointments When aforementioned channel is added and deployed, then through on the patient database, a new button named Todays appointments will appear. By pressing it, only the today’s appointment will be listed. In order to switch between the entire patient database and today’s appointment list, you select the relative button.

To query for a patient ID, the following settings should be applied: Send an enquiry at [email protected] to receive two HL7 channels “Query” and “Response” and then add them to Mirth, Accessible at DYSIS IP Address http://x.x.x.x:8080 (IP shown at Connectivity tab, under network IP) On the Settings: tab EMR, Enable Query When the aforementioned settings have been applied, On Patient Database Page a new Query button is now available. By pressing it, a popup window appears. 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

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