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

  • Page 2: Table Of Contents

    DYSIS Examination Preparation and Functions ............... 26 19.1. Adding data to a Patient visit record ................26 19.2. Using DYSIS to perform examination of the Lower Genital Tract without mapping ..27 19.3. Assigning a visit after a DYSIS Exam from Home screen..........30 19.4.
  • Page 3 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 23.3. SMARTtrack ........................49 Downloading or Printing a Report ................... 51 Additional Functions ....................... 52 25.1. Info ..........................52 25.2. Password tab ........................52 Care, Maintenance and Troubleshooting ................ 53 26.1.

  • Page 4: Applicable Standards

    Refer to Declaration of Conformity (0250-83339) for a list of the compliance standards and guidelines for the DYSIS Ultra 2.0 Digital Colposcope. DYSIS Medical operates a Quality Management System which complies with the requirements of ISO 13485: 2016. The CE 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.

  • Page 5: General Description

    DYSIS Ultra 2.0 Digital Colposcope in good working condition, please follow the operation and maintenance procedures described here-in. 2.1. Intended Users The DYSIS Ultra 2.0 Digital Colposcope is a digital image Colposcope designed to assist clinicians in the in vivo evaluation, documentation and follow up of cervical pathology. 2.2. Intended Patients The DYSIS Ultra 2.0 Digital Colposcope is intended to be used on patients undergoing a colposcopic...

  • Page 6: Optimal Use Of The Pseudo-Colour Imaging (Pci) Feature

    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 7 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 optical head as a handle.
  • Page 8 To avoid power consumption when idle, turn the green power button on the base to OFF position after the unit has completely shut down. The DYSIS Ultra 2.0 Digital Colposcope calibration card should be maintained so it is clean and in good condition.
  • Page 9 SAVE. USB disks used for exporting data (images/ report) should be in exFAT file format. In addition to the device label, the following warning labels are found on the 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 10: Location Of Labels

    Class 2 LED product warning 4.2. Location of Labels The product label (containing the device name, serial number, DYSIS Ultra 2.0 Digital Colposcope legal manufacturer address, Unique Device Identifier Barcode) and the safety labels are located on the back of the PC enclosure.
  • Page 11 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Product Label - containing the device name, serial Safety Label – containing information on LED number, DYSIS Ultra 2.0 Digital Colposcope legal radiation, wavelength and do not push / do not...

  • Page 12: Classifications (Dys403)

    DYSIS Ultra 2.0 Digital Colposcope is a Risk Group 2 LED product according to IEC 62471 The DYSIS reusable metal speculum is a Type BF applied part and the DYSIS disposable speculum is a Type B applied part per International Electro-technical Commission (IEC 60601-1), according to the type of protection against electric shock.

  • Page 13: Environmental Conditions

    There is no impact of atmospheric pressure on the device and it does not require any gases to function. Usage Restrictions 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 14: Components Of Dysis Ultra 2.0 Digital Colposcope

    8.2. ARMS To place the DYSIS Ultra 2.0 Digital Colposcope 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.

  • Page 15: Clinician Monitor

    (see Section 19 for DYSIS Examination) 8.4. 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 coupling adapter. 8.4.1. Camera and Light The camera within the optical head contains LEDs which provide illumination during the colposcopic examination and execution of the DYSISmap.

  • Page 16: Dysis Acetic Acid Applicator

    8.4.3. Speculum Connector (coupling adapter) 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 coupling adapter and pushing back through the hole.

  • Page 17: Power Cord And Power On/Off (Including Shutdown)

    There will be an audible click as the yellow tab moves into the locked position. It will be locked into the device. To remove the power cord once the DYSIS Ultra 2.0 Digital Colposcope has been shut down, pull back on the switch, turn 45 degrees to the left until the notches are lined up and pull out.
  • Page 18 The sterile disposable speculum is manufactured from Eastar™ Copolyester MN058. Disposable treatment pipe (TRP001) The DYSIS disposable diagnostic speculum can be immediately converted to a treatment speculum by the attachment of a sterile disposable Treatment Pipe. The latter is a small plastic tube that is mechanically clipped to the diagnostic speculum offering efficiency advantages to the clinician and comfort advantages to the patient –...

  • Page 19: Powering On The Dysis Ultra 2.0 Digital Colposcope

    Powering on the DYSIS Ultra 2.0 Digital Colposcope To power on the DYSIS Ultra 2.0 Digital Colposcope, ensure it is plugged in to a power supply and press the green power button on the BASE (above the power plug). The DYSIS software should launch automatically when powered on and the on/off switch will illuminate green.

  • Page 20: Dysis Acetic Acid Applicator Kit

    30 days prompting the change. A warning message will also be displayed after 15 cases to check the acetic acid level in the reservoir Positioning for an examination To position DYSIS Ultra 2.0 Digital Colposcope next to the couch ready for operation considerations to be taken into account are: •...

  • Page 21: Dysis Ultra 2.0 Digital Colposcope Software Application

    Type of examination couch Ideally the DYSIS Ultra 2.0 Digital Colposcope 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.
  • Page 22 Revision Date 05-Mar-2021 From the Home screen, the user can enter a NEW PATIENT, start a DYSIS Exam or open the PATIENT DATABASE to review previous visits or add a new visit to an existing patient record by selecting the corresponding button.

  • Page 23: General Navigation Buttons

    17.4. Creating a New Patient Record To create a record for a new patient, the DYSIS Ultra 2.0 Digital Colposcope 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.
  • Page 24 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 All information will be saved to the patient record on pressing SAVE Page 24 of 79...

  • Page 25: New Visit For An Existing Patient

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 17.5. New Visit for an Existing Patient To create a NEW VISIT for an existing patient, first select the patient from the database by selecting PATIENT DATABASE from the home menu and selecting the patient by either scrolling down the list which is alphabetical by LAST NAME.

  • Page 26: Dysis Examination Preparation And Functions

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 DYSIS Examination Preparation and Functions 18.1. Adding data to a Patient visit record After the New Patient record is saved, and again after the colposcopic examination is completed, the user can...

  • Page 27: Using Dysis To Perform Examination Of The Lower Genital Tract Without Mapping

    18.2. Using DYSIS to perform examination of the Lower Genital Tract without mapping To use DYSIS Ultra 2.0 Digital Colposcope to carry out examination of the Lower Genital Tract first create A NEW PATIENT record as described in section 17.4, or adding to an existing patient record as described in 17.5.
  • Page 28 Revision Date 05-Mar-2021 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 18.3. This screen offers the option to magnify the image by using the buttons or by ‘pinch zooming’...
  • Page 29 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 In order to exit and save the images/videos, press the button from the upper left corner and select or simply press Page 29 of 79...

  • Page 30: Assigning A Visit After A Dysis Exam From Home Screen

    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.

  • Page 31: Preparing The Patient

    Ensure the speculum coupling adapter is positioned posteriorly. DYSIS Ultra 2.0 Digital Colposcope can be connected to the speculum via the speculum coupling adapter at the front of the optical head after insertion to stabilise the image during the examination. It is connected by pushing the end of the speculum connecting rod into the opening on the green coupling adapter from the Optical head.
  • Page 32 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 In the DYSIS Exam Mode, several tools and options are available. During the examination, the user has access to the following operations and functions. Symbol Function...

  • Page 33: Additional Options

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 18.6. 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) Displays images that were taken and...
  • Page 34 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.
  • Page 35 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 During the mapping process, a thorough colposcopic examination should be completed. 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.
  • Page 36 When using DYSIS Ultra 2.0 Digital Colposcope, 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.

  • Page 37: Using Dysis Ultra 2.0 Digital Colposcope In Trial Mode

    20. Using DYSIS Ultra 2.0 Digital Colposcope IN TRIAL mode When using DYSIS Ultra 2.0 Digital Colposcope in TRIAL Mode the user will follow the steps as above. 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.
  • Page 38 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Examination Screen (on trial mode – button to add prediction visible) Prior to viewing the map, the user must insert their impression or prediction – either NORMAL, LOW or HIGH according to their observations, a warning message will be displayed if this step has not been completed.
  • Page 39 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Page 39 of 79...

  • Page 40: The Dysis Map

    The table below represents the colour code used to document the tissue acetowhitening dynamics as depicted by DYSIS Ultra 2.0 Digital Colposcope. This colour assignment is based on the intensity and duration of acetowhitening over the period of the dynamic imaging procedure.

  • Page 41: Dynamic Curves

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Colour coding Whitening White Intense Yellow Strong Green Dark blue Weak Cyan Very Weak No Colour Very weak/ None 20.2. Dynamic curves After Dynamic Imaging, users can also review the dynamics of the acetowhitening response of the tissue at any location on the cervix, by pressing “Show Graph”.

  • Page 42: Adding Additional Biopsy Markers

    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...
  • Page 43 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 COLPOSCOPY: Additional colposcopic findings can be documented after the examination. The COLPOSCOPY screen will be automatically displayed after the live image screen is exited. MANAGEMENT PLAN: Management plan following the examination. Additional management plans can be entered after the histology results are completed.
  • Page 44 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 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. Page 44 of 79...
  • Page 45 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 2.0 Digital Colposcope touchscreen Allows the user to view and customise the visit report...

  • Page 46: Patient Database

    Revision Date 05-Mar-2021 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.
  • Page 47 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 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.

  • Page 48: Visit History

    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.

  • Page 49: Smarttrack

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 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 longitudinal tracking of patient management and outcomes.
  • Page 50 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 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.

  • Page 51: Downloading Or Printing A Report

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

  • Page 52: Additional Functions

    LOCKOUT and other functions of the DYSIS Ultra 2.0 Digital Colposcope. Access to the settings functions are via an Administrator password only, which can be set by your 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.

  • Page 53: Care, Maintenance And Troubleshooting

    Care, Maintenance and Troubleshooting 25.1. General Prior to cleaning DYSIS Ultra 2.0 Digital Colposcope, turn off the power by shutting down the DYSIS Ultra 2.0 Digital Colposcope and turning off and unplugging DYSIS Ultra 2.0 Digital Colposcope from the mains power outlet Do not immerse any part of DYSIS Ultra 2.0 Digital Colposcope into cleaning solutions...

  • Page 54: Touchscreen Monitor Cleaning

    MOVEMENTS – EITHER UP AND DOWN OR SIDE TO SIDE. 25.6. Disinfection 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 55: Dysis Acetic Acid Applicator

    25.10. Routine Electrical Testing The DYSIS Ultra 2.0 Digital Colposcope system can be split into 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.

  • Page 56: Troubleshooting

    DYSIS Medical discourages the performance of any maintenance, troubleshooting or service actions on DYSIS Ultra 2.0 Digital Colposcope other than those specified in this guide. If DYSIS Ultra 2.0 Digital Colposcope malfunctions, or if there is a suspicion that it underperforms, please follow the guidelines below before contacting the DYSIS Medical service department.
  • Page 57 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Colposcope’s base may be loose/disconnected Computing unit Contact DYSIS Medical service malfunction department Computing unit turns on, the Shut down the device and restart. If software functions, but the...

  • Page 58: Software Messages

    A message shown when CANCEL is pressed after a direct All Visit Data/Images will be Discarded. DYSIS Exam. By selecting OK all data of the visit will be Press OK to Confirm discarded. When this message is displayed, DYSIS Exam is disabled.
  • Page 59 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Please Enter the Number of Months for The option "Other" has been selected, so please indicate the Colposcopy Follow Up the number of months for the colposcopy follow up Please Enter the Number of Months for The option "Other"...

  • Page 60: Replacing The Dysis Acetic Acid Applicator

    DYSIS Ultra 2.0 Digital Colposcope 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.

  • Page 61: Weee Regulations

    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”...

  • Page 62: Essential Performance

    Furthermore, the DYSISmap is not used to cancel an otherwise appropriate biopsy, so disease will not be missed because of a DYSISmap failure. 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.

  • Page 63: Technical Description

    • Idle Footprint - Length, Width, Height (cm): 70 x 70 x 165 • DYSIS Ultra 2.0 Product Weight: 69 Kg (Plus packaging 80 Kg) • Packaging dimensions - Length, Width, Height (cm): 83 x 83 x 143 Each DYSIS Ultra 2.0 Digital Colposcope system is accompanied by: •...

  • Page 64: Appendix 1: Administrator Settings

    In the SETTINGS menu DYSIS Ultra 2.0 Digital Colposcope 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 2.0 Digital Colposcope.

  • Page 65: System

    In addition, the user can carry out CALIBRATION, export LOG FILES for routine maintenance or to assist with remote repair. DYSIS Ultra 2.0 Digital Colposcope also offers the option to BACK UP and RESTORE data. This should only be carried out under the supervision of a DYSIS technician.

  • Page 66: Password And User Tabs

    Full training and advice on these functions will be given by DYSIS personnel on installation. An export path should be first configured so that DYSIS Ultra 2.0 Digital Colposcope will recognise the USB stick. By 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.

  • Page 67: Export

    0230-53095, Rev 05 Revision Date 05-Mar-2021 The DYSIS team will assist staff to set passwords on installation. 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 entering new users a default password is applied.

  • Page 68: Adding A Printer

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 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 2.0 Digital Colposcope.
  • Page 69 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Go to the Administration tab, as shown below and press Add Printer under the Printers section The following screen will appear: For a network printer, select the LPD/LPR Host or Printer option and then press Continue.
  • Page 70 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 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.
  • Page 71 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 When instructed, just select default options. Page 71 of 79...

  • Page 72: Emr

    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 for DYSIS Ultra 2.0 Digital Colposcope (through Settings, tab Export). The EMR Tab is only available via DYSIS personnel and Hospital Administrators.

  • Page 73: Dicom Storage

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 The EMR tab enables the user to allow DYSIS Ultra 2.0 Digital Colposcope 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 2.0 Digital Colposcope System to Store Images to the PACS, the following settings...

  • Page 74: Hl7 (Adding Appointments & Patient Demographics Retrieval)

    0230-53095, Rev 05 Revision Date 05-Mar-2021 c. HL7 (adding appointments & patient demographics retrieval) To add appointments to DYSIS Ultra 2.0 Digital Colposcope the following settings should be applied: Send an enquiry at emr@dysismedical.com to receive an HL7 channel “Add appointment” and then add it to Mirth, Accessible at DYSIS Ultra 2.0 Digital Colposcope IP Address...
  • Page 75 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-2021 Page 75 of 79...

  • Page 76: Appendix 2: 60601-1-2 Data

    DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-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 5109TC2.
  • Page 77 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-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 78 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-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 79 DYSIS Ultra 2.0 Digital Colposcope Instructions for Use 0230-53095, Rev 05 Revision Date 05-Mar-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...

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