DYSIS Ultra 2.0 User manual

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

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
Page 2of 79
CONTENTS
1. Applicable Standards.........................................................................................................4
2. General Description...........................................................................................................5
3. Indications for Use.............................................................................................................5
4. Optimal Use of the Pseudo-Colour Imaging (PCI) feature.................................................6
5. Summary of Warnings and Cautions .................................................................................6
5.1. Location of Labels............................................................................................................10
6. Classifications (DYS403)...................................................................................................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 2.0 Digital Colposcope ........................................................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 (coupling adapter).........................................................................16
10. Power cord and Power On/Off (including shutdown).....................................................17
11. Assembling and inserting the power cord.......................................................................17
12. List of Additional Components ........................................................................................17
13. Powering on the DYSIS Ultra 2.0 Digital Colposcope.......................................................19
14. Powering Off the DYSIS Ultra 2.0 Digital Colposcope......................................................19
15. Overview –Operating DYSIS Ultra 2.0 Digital Colposcope..............................................19
16. DYSIS Acetic Acid Applicator Kit ......................................................................................20
17. Positioning for an examination .......................................................................................20
18. DYSIS Ultra 2.0 Digital Colposcope Software Application ...............................................21
18.1. Logging In ........................................................................................................................21
18.2. Home Menu.....................................................................................................................21
18.3. General navigation buttons.............................................................................................23
18.4. Creating a New Patient Record .......................................................................................23
18.5. New Visit for an Existing Patient .....................................................................................25
19. 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. Using DYSIS Ultra to carry out a standard colposcopic examination ..............................30
19.5. Preparing the patient ......................................................................................................31
19.6. Additional Options...........................................................................................................33
20. Starting the DYSIS Exam ..................................................................................................33
21. Using DYSIS Ultra 2.0 Digital Colposcope IN TRIAL mode................................................37
21.1. The DYSIS Map.................................................................................................................40
21.2. Dynamic curves ...............................................................................................................41
21.3. Adding additional biopsy markers...................................................................................42
21.4. Biopsy point viewing .......................................................................................................42
21.5. Exiting the Exam ..............................................................................................................42
22. Additional information post colposcopic examination ...................................................42
23. Patient Database .............................................................................................................46
23.1. Reviewing a visit ..............................................................................................................46
23.2. Visit History .....................................................................................................................48

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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Revision Date 05-Mar-2021
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23.3. SMARTtrack.....................................................................................................................49
24. Downloading or Printing a Report...................................................................................51
25. Additional Functions .......................................................................................................52
25.1. Info ..................................................................................................................................52
25.2. Password tab...................................................................................................................52
26. Care, Maintenance and Troubleshooting........................................................................53
26.1. General............................................................................................................................53
26.2. Replacement of Parts ......................................................................................................53
26.3. ARM, BASE and Computer Housing Cleaning..................................................................53
26.4. Touchscreen Monitor Cleaning .......................................................................................54
26.5. Optical Head Cleaning .....................................................................................................54
26.6. Disinfection .....................................................................................................................54
26.7. DYSIS Specula ..................................................................................................................54
26.8. DYSIS Acetic Acid Applicator ...........................................................................................55
26.9. Periodic Cleaning and Maintenance................................................................................55
26.10. Routine Electrical Testing................................................................................................55
26.11. Connecting an external monitor .....................................................................................55
26.12. Troubleshooting ..............................................................................................................56
26.12.1. Troubleshooting guide ....................................................................................................56
26.12.2. Software messages..........................................................................................................58
26.13. Replacing the DYSIS Acetic acid applicator .....................................................................60
27. Warranty, Service, Expected Service Life and Recycling .................................................60
27.1. WEEE Regulations ...........................................................................................................61
28. Contact Information........................................................................................................61
29. Essential Performance.....................................................................................................62
30. Technical Description ......................................................................................................63
31. Appendix 1: ADMINISTRATOR SETTINGS ........................................................................64
i. Settings............................................................................................................................64
ii. Connectivity ....................................................................................................................64
iii. System.............................................................................................................................65
iv. Password and User tabs..................................................................................................66
v. Export..............................................................................................................................67
a. Adding a printer ..............................................................................................................68
vi. EMR.................................................................................................................................72
a. DICOM Storage................................................................................................................73
b. Modality worklist ............................................................................................................73
c. HL7 (adding appointments & patient demographics retrieval) ......................................74
32. Appendix 2: 60601-1-2 DATA ..........................................................................................76

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
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1. 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.
USA Patent No 7749162
FDA 510(k) Clearance letter K092433

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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Revision Date 05-Mar-2021
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2. General Description
Thank you for purchasing the DYSIS Ultra 2.0 Digital 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 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
examination in hospitals and clinics by healthcare providers 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.
2.3. Contraindications
There are no specific contraindications for the use of the DYSIS Digital Colposcope on patients, other than
any relative contraindications to a patient having a colposcopic procedure in general. These have to be
evaluated and determined by the healthcare provider, and may include the patient's ability to tolerate a
standard speculum examination, conditions that may be best treated in advance such as acute cervicitis and
severe vaginitis, anticoagulant use, or heavy bleeding.
2.4. Indications for Use
The DYSIS Ultra 2.0 Digital Colposcope 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 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 the DYSIS Digital
Colposcope (e.g. electrosurgical equipment) should also be read and understood. Failure to do so may result
in injury to the patient and/or damage to the DYSIS Digital Colposcope.

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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Revision Date 05-Mar-2021
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Electromagnetic Interference
The use of diathermy equipment on the same electrical supply as DYSIS Ultra can cause electromagnetic
interference which is witnessed as an interruption to the video stream. Using a galvanic isolation transformer
between the a.c. mains supply and DYSIS Ultra can successfully prevent the interference.
3. 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 (movement of the cervix whilst patient is undergoing examination) 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.
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.
DYSIS intended operator:
Education/ Minimum Knowledge:
A physician or a medical professional that is trained in, and qualified to perform, colposcopic
procedures
Language Understanding:
English
Minimum Experience:
Experience in the colposcopic procedures
Permissible Impairments:
As applied in regular colposcopic practice
4. 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 Ultra 2.0 Digital Colposcope 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)

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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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.
4.1. Do not use the DYSIS Ultra 2.0 Digital Colposcope if it appears to be damaged or broken.
The power cable must always be positioned so as to minimise risk for tripping.
Do NOT position the device in a way that makes it difficult to disconnect the device from the mains supply. The
power switch at the back of the device should always be kept easily accessible so that the power can be
switched off.
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. The unit should always
be in the transport position and held / controlled while it is being moved.
Stepping and sitting on the device is prohibited.
Before using the DYSIS Ultra 2.0 Digital Colposcope, make sure that it is in optimal use condition.
Do not spill any liquids on the device.
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 the DYSIS Ultra 2.0 Digital Colposcope, please ensure the touchscreen is 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 the DYSIS Ultra 2.0 Digital Colposcope, make sure that the foot brake has been released and
the wheels have been lowered.
Always engage the foot brake before an examination.
The DYSIS Ultra 2.0 Digital Colposcope should be positioned on a flat floor and the foot brake engaged to
prevent movement and toppling.
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 the DYSIS Ultra 2.0 Digital Colposcope or
that have been specified as being compatible with DYSIS Ultra 2.0 Digital Colposcope.
To avoid the risk of electric shock, DYSIS Ultra 2.0 Digital Colposcope should only be connected to a power
supply with protective grounding.

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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Revision Date 05-Mar-2021
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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 green 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 2.0 Digital
Colposcope will shut down automatically.
•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.
Ensure any external data storage media have been checked for malware (viruses, trojans, etc.) before
connecting to DYSIS Ultra 2.0 Digital Colposcope.
Do not spray solutions or liquids into air vents.
Do not immerse any part of the device in cleaning solutions and do not sterilise any part of the device.
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 2.0
Digital Colposcope.
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.

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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.
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.
The acetic acid container holds 30ml of acetic acid and the software provides a prompt to the user that there
is 15ml (10 exams) left in the container.
While the DYSISmap measurement is in progress, do not obscure the light beam or the camera. While the
DYSISmap measurement is in progress, patient 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.
Access to the database is password controlled and therefore restricted for unregistered users.
The “Required” marked fields in the “New Patient” form are mandatory. The patient data is saved only upon
pressing 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.
The attachable speculum, if
reusable, is a Type-BF applied part
that provides protection against
electric shock.
CONSULT: Refer to instruction
manual/booklet
NOTE: This symbol is used to signify
the instruction manual/booklet
must be read
General warning sign.

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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Revision Date 05-Mar-2021
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Hand crush warning.
Do not push DYSIS Ultra 2.0 Digital
Colposcope.
Do not step on DYSIS Ultra 2.0
Digital Colposcope.
LED emission
Class 2 LED product warning
4.2. Location of Labels
The product label (containing the device name, serial number, DYSIS Ultra 2.0 Digital Colposcope legal
manufacturer address, Unique Device Identifier Barcode) and the safety labels are located on the back of the
PC enclosure.
Product and safety (warning) labels included on each device as per examples below: