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
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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.................................................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

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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

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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

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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.

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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)

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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.

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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.

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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:

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Product Label - containing the device name, serial
number, DYSIS Ultra 2.0 Digital Colposcope legal
manufacturer address, Unique Device Identifier
Barcode
Safety Label –containing information on LED
radiation, wavelength and do not push / do not
stand labels

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5. Classifications (DYS403)
The DYSIS Ultra 2.0 Digital Colposcope is a Class-IIa device according to the 93/42/EEC Medical Device Directive
and a Class-II device as per the US FDA classification.
ME Classification –class II device as it contains a protectively earther power supply.
DYSIS Ultra 2.0 Digital Colposcope IP rating 00 (no protection against contact and ingress of objects or liquids).
DYSIS Ultra 2.0 Digital Colposcope 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 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.
The DYSIS Ultra 2.0 Digital Colposcope Optical Head is not an applied part but could accidentally come in
contact with the patient’s leg. 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 2.0 Digital Colposcope is Class II. Refer to technical documentation for
more information on electrical safety per IEC 60601-1.
Mode of operation; DYSIS Ultra 2.0 Digital Colposcope is classified for continuous operation.

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6. Environmental Conditions
6.1. Storage
DYSIS Ultra 2.0 Digital Colposcope 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).
6.2. Usage
DYSIS Ultra 2.0 Digital Colposcope 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).
6.3. Transportation
During shipping, DYSIS Ultra 2.0 Digital Colposcope 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).
6.4. Atmospheric Pressure
There is no impact of atmospheric pressure on the device and it does not require any gases to function.
7. 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:
Appropriately trained DYSIS Medical personnel carry out assembly/test operations, extensions, readjustments,
modifications or repairs;
The electrical installation of the room complies with the electrical requirements of the hospital and the DYSIS
Ultra 2.0 Digital Colposcope is used in accordance with the instructions for use.
Users must read the instructions in this guide carefully before operating the device.
DYSIS Ultra 2.0 Digital Colposcope must not be used if it appears to be damaged or broken.
There are no user replaceable parts in DYSIS Ultra 2.0 Digital Colposcope 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, the DYSIS Ultra 2.0 Digital Colposcope is not intended to come into contact with the
patient.
Users and Patients should not stare directly into the illumination source when DYSIS Ultra 2.0 Digital
Colposcope is ON.
Air vents must be kept unobstructed.
Do not sit, lean or step on DYSIS Ultra 2.0 Digital Colposcope; do not place any items (such as instruments,
coffee, weights, etc. on DYSIS Ultra 2.0 Digital Colposcope). Do not push or pull DYSIS Ultra 2.0 Digital
Colposcope in a way other than the way instructed in this guide or as instructed by DYSIS Medical
representative for proper operation.

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8. Components of DYSIS Ultra 2.0 Digital Colposcope
(1) Display Arm
(2) Clinician Monitor
(3) Imaging head
(4) Optical Arm
(5) Base (including enclosure)
(6) Foot pedal/brake
Optical Head
Base showing PC enclosure
Speculum and coupling adapter
8.1. BASE / Moving the Instrument
On the base, there is a foot pedal to engage/disengage the brake. To move DYSIS Ultra 2.0 Digital Colposcope,
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.
When moving the DYSIS Ultra 2.0 Digital Colposcope the user should release the footbrake and push the metal
pole at the top. The device should NOT be pushed using the arms, optical head or monitor. Care should be
taken to protect exposed parts when manoeuvring.
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.

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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.
8.3. Clinician Monitor
The clinician monitor is a touchscreen monitor. It is used during the colposcopic examination to perform the
procedure. (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.

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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.
Caution: Possibly hazardous optical radiation emitted from this product. Do not stare at operating lamp.
May be harmful to the eyes.
The camera and Light are automatically on when in examination mode.
8.4.2. DYSIS Acetic Acid Applicator
An automatic spraying system (for acetic acid application) is integrated into the optical head. (See Section 25.8
for changing the 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. It is considered as part of the DYSIS acetic acid applicator kit.
CORRECT insertion of the
coupling adapter
INCORRECT insertion of
coupling adapter

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To release the speculum from the speculum coupling adapter, hold the back of the speculum to stabilize, place
your thumb from your other hand on the back of the speculum coupling adapter under the tubing and gently
push the back of the specula from the insertion point.
9. Power cord and Power On/Off (including shutdown)
The DYSIS Ultra 2.0 Digital Colposcope unit should only be used with the supplied AC/DC power supply unit.
Device shutdown - the device should be isolated from the mains supply by switching the unit off.
10. Assembling and inserting the power cord
Insert the end of the power cord into the power supply unit (PSU). To insert the power cord into the central
processing unit (CPU), 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.
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.
11. List of Additional Components
The only consumables (components) that are used with the DYSIS Ultra 2.0 Digital Colposcope are the
following and are designed to be specifically used with the DYSIS colposcope:
Acetic acid kit (ACE004)
Acetic acid (3-5% concentration) is delivered to the patient’s cervix by an automated spray system which is
controlled by the system software. The maximum volume delivered is 1.5ml. The aim of the acetic acid is to
provide acetowhitening for the identification of abnormal cells which is a standard colposcopic procedure.

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Disposable speculum (DSP001, DSP002, DSP003)
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 –the treatment pipe has no direct contact with the patient. The disposable treatment pipe is
manufactured from Polyprop 3020 SMB3.
Reusable specula
The reusable speculum is manufactured from medical grade stainless steel.

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12. 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.
DO NOT TOUCH THE BUTTONS ON THE BACK OF THE MONITOR. FAILURE TO FOLLOW THESE
RECOMMENDATIONS CAN RESULT IN MONITOR MALFUNCTION.
13. Powering Off the DYSIS Ultra 2.0 Digital Colposcope
To turn off the DYSIS Ultra 2.0 Digital Colposcope, press SHUTDOWN from the left panel of HOME screen or
from the LOGIN screen and wait for the DYSIS Ultra 2.0 Digital Colposcope to shut down. DO NOT SWITCH THE
DYSIS Ultra 2.0 Digital Colposcope OFF BY CUTTING THE POWER OR OPERATING THE POWER SWITCH UNTIL IT
HAS SHUT DOWN FROM THE TOUCHSCEEN. FAILURE TO FOLLOW THESE RECOMMENDATIONS CAN RESULT IN
LOST DATA.
14. Overview –Operating DYSIS Ultra 2.0 Digital Colposcope
DYSIS Ultra 2.0 Digital Colposcope 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 2.0 Digital Colposcope
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 2.0 Digital Colposcope has been designed to ensure
that you are able to comply with this requirement when using DYSIS Ultra 2.0 Digital Colposcope in ‘TRIAL’
mode. Therefore, the examination process will proceed as follows:
Examination preparation
Initiate DYSISmap procedure

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
Page 20 of 79
Colposcopy examination (including application of acetic acid to observe acetowhitening effect)
Selection of biopsy points (after standard colposcopic assessment)
Insert initial prediction
Observe and review 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: 18.5 - 21
15. 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 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 25.8 for instructions how to change the DYSIS acetic acid applicator, a warning message will
be displayed every 30 days prompting the change. A warning message will also be displayed after 15 cases to
check the acetic acid level in the reservoir
16. 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:
•Space available
•Position of power points