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DYSIS Ultra 2.0 Instructions For Use Manual

Digital colposcope
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DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date: 25-Feb-2021
DYSIS Ultra 2.0 Digital Colposcope
Instructions for Use

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  • Page 1 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date: 25-Feb-2021 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use...

  • Page 2: Table Of Contents

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 CONTENTS General Information Information for Intended Users and Patients Indications for Use Use of the Pseudo-Color Imaging (PCI) feature (DYSISmap Summary of Warnings and Cautions Location of Product Labels...

  • Page 3: General Information

    2.1. Intended Users The DYSIS Ultra 2.0 Digital Colposcope is a digital imaging system designed to assist clinicians in the in vivo evaluation, documentation and follow up of the lower genital tract. The DYSIS Ultra 2.0 Digital Colposcope is intended to be used in hospitals and clinics by users thoroughly trained in the appropriate medical procedures.

  • Page 4: Indications For Use

    Revision Date 25-Feb-2021 A risk assessment has been performed for the DYSIS Ultra 2.0 Digital Colposcope and all residual risks have been assessed and reduced to as low as practicably possible. No undesirable side effects from using this device or acetic acid (acetowhitening process) have been identified.
  • Page 5 Do not tilt, push, pull, or move DYSIS Ultra 2.0 Digital Colposcope in ways other than that described in this manual for its proper/optimal and safe use. The unit should be held at the top of the pole when it is being transported and should never be moved using the cables or imaging head as a handle.
  • Page 6 Examine the functionality of the arm prior to examining a patient and ALWAYS before proceeding to connect a DYSIS speculum. Connect only components that are specified in this guide as part of DYSIS Ultra 2.0 Digital Colposcope or that have been specified as being compatible with DYSIS Ultra 2.0 Digital Colposcope.
  • Page 7 Using the handle of the imaging head to transport the device may result in a loss of device performance and stability and could cause injury to the user/patient. To ensure optimal operation and safety, users should not remove any of the connectors on DYSIS Ultra 2.0 Digital Colposcope.
  • Page 8 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 In addition to the device label, the following warning labels are found on DYSIS Ultra 2.0 Digital Colposcope or within this document: The disposable speculum is a Type-B applied part that provides protection against electric shock.

  • Page 9: Location Of Product Labels

    Revision Date 25-Feb-2021 Location of Product Labels The product label (containing the device name, serial number, DYSIS Ultra 2.0 Digital Colposcope legal manufacturer address and Unique Device Identifier Barcode) and the warning labels are located on the back of the PC enclosure.

  • Page 10: Classifications (Dys403)

    DYSIS Ultra 2.0 Digital Colposcope is a Risk Group 2 LED product according to IEC/EN 60825-1. DYSIS reusable metal specula are a Type BF applied part and the DYSIS disposable specula are a Type B applied part per International Electro-technical Commission (IEC 60601-1), according to the type of protection against electric shock.

  • Page 11: Usage Restrictions

    Usage Restrictions The DYSIS Ultra 2.0 Digital Colposcope 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 2.0 Digital Colposcope is the manufacturer’s responsibility only if:...

  • Page 12: System And Components

    Revision Date 25-Feb-2021 System and Components The components making up the DYSIS Ultra 2.0 colposcope are shown in Fig 3 and 4 and are summarized in the following section. Fig 3: DYSIS ULTRA 2.0: (1) Display Arm; (2) Clinician Monitor; (3) Imaging Head;...
  • Page 13 10.2. Arms To place DYSIS Ultra 2.0 Digital Colposcope in the most suitable position for use, the two arms (Fig ) can be easily adjusted. It requires minimal effort for repositioning, and it is not required that it is locked in position.
  • Page 14 Please see Section 20.10 for instructions on how to replace the DYSIS acetic acid applicator. A warning message will be displayed every 30 days prompting the DYSIS acetic acid applicator to be replaced. A warning message will also be displayed after 15 examinations, prompting the user to check the acetic acid level in the reservoir.

  • Page 15: Power Cord And Power On/Off (Including Shutdown)

    Fig 9: Inserting the power cord To remove the power cord after DYSIS Ultra 2.0 Digital Colposcope is shut down, pull back on the yellow tab, rotate 45 degrees to the left until the notches are lined up and then pull out.

  • Page 16: Power On And Off

    Power On and Off To power on the DYSIS Ultra 2.0 Digital Colposcope, ensure it is plugged into a power supply and that the power supply is connected to a suitable outlet. Then press the green power button on the base (found above the power plug inlet as shown in Fig 10).

  • Page 17: Overview Of Operation

    15.1. Logging In After turning the DYSIS Ultra 2.0 Digital Colposcope on, the user must LOGIN to access the application (Fig 10 & 11). The application displays a keyboard on the touchscreen and prompts the user to provide a username and password (default usernames and passwords are provided upon installation and can then be customized).
  • Page 18 Fig 12: Home screen From the HOME screen, the user can enter a NEW PATIENT, start a DYSIS EXAM or access the PATIENT DATABASE to review previous visits or add a new visit to an existing patient record by selecting the corresponding button.
  • Page 19 HOME menu, dependent on the mode in use. takes 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.
  • Page 20 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 To successfully create a patient record, the fields marked “Required” must be completed and then press SAVE. Fig 14: New Patient information Additional information can be added by selecting each icon from the left panel of the NEW PATIENT screen including address, general information and obstetric history (Fig 15).

  • Page 21: Examination Preparation And Functions

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 16: Database patient listing After selecting the patient, select NEW VISIT from the boxes highlighted at the bottom right of the screen (Fig 17). A NEW VISIT record will be created. Information on the NEW VISIT can be entered in the same manner as described in Section 16.1 below.
  • Page 22 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 18-20). This includes the referral reason for the examination, additional information about the patient (and eventually the indicated management plan and histology results). Fig 18: New visit form...
  • Page 23 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 20: additional patient information Page 23 of 61...
  • Page 24 The DYSIS Ultra 2.0 Digital Colposcope can be connected to the speculum via the speculum connector located at the front of the imaging head after insertion to stabilize the image during the examination. It is connected by pushing the end of the speculum into the opening on the green connector rod of the imaging head.
  • Page 25 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Several operations and functions are available during the examination: Symbol Function Description Takes a still image of the current view. Can be taken while filters are applied or when Save Image image is zoomed.
  • Page 26 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 222: Image capture 16.5. Additional Options Additional options are available by pressing during the examination (Fig 22 & 23). Fig 23: Examination screen (with left menu shown)

  • Page 27: Dysis Mapping

    Fig24: Examination screen (after selecting Enter DYSIS Mode) Prior to initiating the DYSIS mapping, the patient should be instructed to remain as still as possible. Upon pressing Start DYSIS Mapping, 1.5 cc of acetic acid will be diffused homogenously over the cervix and the mapping process will begin.
  • Page 28 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig25: Examination screen (DYSIS mapping in progress) During the mapping, a timer will display in the lower right corner of the screen. It requires at least 125 seconds of information for the map to be calculated, and the process will automatically stop at 185 seconds.
  • Page 29 NORMAL, LOW or HIGH. When using DYSIS Ultra 2.0, at any moment during dynamic imaging, the user can review the images that have been captured thus far by pressing the playback icon. The playback can be accessed by selecting the button at the bottom of the screen in live viewing.
  • Page 30 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 28: Examination screen after mapping has completed (but before DYSISmap has been shown) PLEASE NOTE: The user must ALWAYS select biopsy points based on the conventional colposcopic examination before viewing the DYSISmap.
  • Page 31 The DYSIS Ultra 2.0 Digital Colposcope will document the dynamic optical phenomena associated with the cervical acetowhitening in a color-coded map (DYSISmap, Fig 29). The DYSIS Ultra 2.0 Digital Colposcope captures high-resolution, sequential images. The images are automatically aligned to compensate for small tissue movements and contractions and then are used to calculate the DYSISmap.
  • Page 32 The table below represents the color code used to document the tissue acetowhitening dynamics as depicted by DYSIS Ultra 2.0. This color assignment is based on combining the intensity and duration of acetowhitening over the time period of the dynamic imaging procedure.
  • Page 33 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Additional biopsy markers can be added (and removed if required) after the DYSISmap has been displayed (Fig 30) Biopsy markers that were added prior to the map will be displayed in bright blue (and can no longer be removed);...
  • Page 34 Revision Date 25-Feb-2021 17.5. Assigning to a patient after a DYSIS Exam initiated directly from the HOME screen After saving images, videos or having performed an examination (Fig 31), exit the DYSIS exam screen and the following screen will appear:...
  • Page 35 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 32: Patient visit record Additional colposcopic findings can be documented after the examination. The COLPOSCOPY screen is automatically displayed after exiting the examination (Fig 32 & 33).
  • Page 36 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 The user can complete the management plan (Fig 34) following the examination. Additional options on the management plan may be entered after the histology results have been made available.
  • Page 37 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Additional information can be added into the visit record by using the on-screen keyboard within the NOTES section (Fig 36). Fig 36: Notes form The right side of the screen offers additional options after the examination: Replays the DYSIS exam (all the sequential images that were automatically captured for the mapping).

  • Page 38: Patient Database

    Revision Date 25-Feb-2021 Patient Database The patient database offers up to a maximum of 1 TB of data, approximately equivalent to over 5,000 DYSIS examinations. (This storage capacity will vary according to the length of videos, number of maps generated, etc.) 18.1.
  • Page 39 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 38: Selecting a patient OPEN in the top right corner will open a more detailed copy of the patient’s record and visits after the patient has been selected. It is also possible to EDIT a patient’s details.
  • Page 40 18.2. Visit History The DYSIS patient records can be amended at any time after a visit and those changes will be logged (Fig 41). For example, if a patient’s referral reason was not available at the time of examination but the result is to be entered later, the information can be entered by selecting the appropriate boxes in each section.
  • Page 41 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 41: Visit history log Following confirmation, the new information will appear in the VISIT HISTORY section of the patient record. 18.3. SMARTtrack SMARTtrack allows the user to compare, side-by-side, two visits of a patient, allowing longitudinal tracking (Fig 42).
  • Page 42 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 When is displayed, the two visits can be reviewed 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.
  • Page 43 NOTES section of the patients visit record. 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 2.0 Digital Colposcope or closed. Fig 44: DYSIS report...

  • Page 44: Additional Functions

    To start the simulation case, select Simulator then Enter DYSIS Mode to access the functionality of the user interface and perform a patient exam. Use all of the exam function and perform a DYSIS exam with the simulated exam. Refer to Section 16.4 on how to perform a DYSIS Exam.
  • Page 45 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 45: Calibrate option If calibration has expired, a message will appear to prompt the user to calibrate the system (Fig 46). Acknowledge the message by selecting OK and access the CALIBRATE option from the left panel of the HOME screen.
  • Page 46 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Fig 47: Calibration set up By pressing the CALIBRATE button, the following screen appears (Fig 48): Fig 48: Calibration screen After pressing START, the user should follow the instructions as three sequential messages are displayed (Fig 49).

  • Page 47: Care, Maintenance And Troubleshooting

    Do not immerse any part of DYSIS Ultra 2.0 Digital Colposcope into cleaning solutions. When not in use, the DYSIS Ultra 2.0 Digital Colposcope should be stored with the ARMs folded towards the pole. This will ensure that when the DYSIS Ultra 2.0 Digital Colposcope is moved, the monitor and the imaging head are protected.
  • Page 48 STRAIGHT MOVEMENTS – EITHER UP AND DOWN OR SIDE TO SIDE. If needed the DYSIS Ultra 2.0 Digital Colposcope can be wiped with a soft cloth dampened with 70% isopropanol alcohol, disinfectant wipes (chlorhexidine for viral control) and similar substances. DYSIS Ultra 2.0 Digital Colposcope is not intended to be sterilized.
  • Page 49 DYSIS Ultra 2.0 Digital Colposcope electrical system consists of two parts: 1) the 240v double insulated ( ) power pack and 2) the 12v DYSIS Ultra 2.0 Digital Colposcope instrument. The power pack can be tested to meet current electrical testing requirements for Class 2, double insulated devices. The DYSIS Ultra 2.0 Digital Colposcope is below the SELV limits of 50 V AC and therefore does not require any routine electrical testing to be performed.
  • Page 50 Make sure the instrument is shut down, disconnect it from the power source and restart it to confirm the issue persists, before contacting technical support. If any of the suggested actions fail to solve the issue, please contact the DYSIS Medical service department at 844- DYSISMED.
  • Page 51 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 persists, contact DYSIS Medical service department. Weekly calibration is Calibrate the system. required Image is displayed, but the lights do not turn Illumination source Contact DYSIS Medical service malfunction department.
  • Page 52 When this message is displayed, DYSIS Exam is disabled. Shut An error has been detected in the down the DYSIS Ultra 2.0 Digital Colposcope and then start it up camera/syringe. Please contact DYSIS again. If message persists, please contact DYSIS Medical service department.
  • Page 53 0330-53095 R4 Revision Date 25-Feb-2021 Please contact the Administrator to check the printer is No printer currently configured. Please accessible and DYSIS Ultra 2.0 Digital Colposcope is configured contact an administrator. for the printer. Please enter the number of months for The option "Other"...
  • Page 54 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 20.10. Replacing the DYSIS Acetic Acid Applicator 20.10.1. Removing the existing Acetic Acid Applicator Kit: 1. Push the container upwards from the bottom in order to remove it from the holder Fig 52).

  • Page 55: Warranty, Service, Expected Service Life, Recycling And Disposal

    DYSIS Ultra 2.0 Digital Colposcope has an expected service life (lifecycle) of 10 years from the date the system was installed. Metal parts, such as the movable base and the pole can be recycled in metal recycling facilities.

  • Page 56: Contact Information

    Tel: +44 (0) 131 516 3944 Essential Performance DYSIS Ultra 2.0 is a digital colposcope that enables clinicians to illuminate and visualize the cervix uteri so that they perform a colposcopic examination. Typically, colposcopy is performed on women that have been referred after a screening test (cytology and/or HPV) indicated suspicion for disease.

  • Page 57: Technical Description

    0330-53095 R4 Revision Date 25-Feb-2021 Neither the DYSIS device nor the DYSISmap are diagnosis aids, and even more so, as colposcopy that they are used for is not intended to provide a direct diagnosis of a patient’s condition. In conclusion, use of DYSIS Ultra 2.0 Digital Colposcope does not depend on essential performance.

  • Page 58: Appendix 2: 60601-1-2 Data

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Appendix 2: 60601-1-2 DATA Tables of guidance and manufacturer’s declaration regarding electromagnetic emissions and immunity as per EN 60601-1-2:2015. Data extracted from Eurofins York EMC Test Report 5104TC2.
  • Page 59 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 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...
  • Page 60 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Surges 0.5 and 1kV line to line Pass EN61000-4-5:2006 0.5, 1 and 2kV line to earth Referenced in Table 5 (Page 35) Mode 1 EN60601-1-2: 2015 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances –...
  • Page 61 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0330-53095 R4 Revision Date 25-Feb-2021 Electrical Transient conduction along supply lines Not applicable ISO7637-2 Patient coupling port (Table 7 – Page 38) Electrostatic Discharge 2, 4, 8, 15kV air EN61000-4-2: 2009 2, 4, 6, 8kV contact No...

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