DYSIS Ultra 2.0 User manual

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

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
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CONTENTS
1. General Information 3
2. Information for Intended Users and Patients 3
3. Indications for Use 4
4. Use of the Pseudo-Color Imaging (PCI) feature (DYSISmapTM) 4
5. Summary of Warnings and Cautions 4
6. Location of Product Labels 9
7. Classifications (DYS403) 10
8. Environmental Conditions 10
9. Usage Restrictions 11
10. System and Components 12
11. Power Cord and Power On/Off (including shutdown) 15
12. List of Additional Components 15
13. Power On and Off 16
14. Overview of operation 17
15. The DYSIS Ultra 2.0 Software Application 17
16. Examination Preparation and Functions 21
17. DYSIS mapping 27
18. Patient Database 38
19. Additional Functions 44
20. Care, Maintenance and Troubleshooting 47
21. Warranty, Service, Expected Service Life, Recycling and Disposal 55
22. Contact Information 56
23. Essential Performance 56
24. Technical Description 57
25. Appendix 2: 60601-1-2 DATA 58

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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1. General Information
Thank you for purchasing the DYSIS Ultra 2.0 Digital Colposcope (DYS403), manufactured by DYSIS Medical Ltd.
Please read this guide carefully before using your equipment. DYSIS has been designed to maximize safety and
minimize 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 herein.
Refer to the 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 that has been certified
for compliance 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
2. Information for Intended Users and Patients
2.1. Intended Users
The DYSIS Ultra 2.0 Digital Colposcope is a digital imaging system designed to assist clinicians in the in vivo
evaluation, documentation and follow up of the lower genital tract.
The DYSIS Ultra 2.0 Digital Colposcope is intended to be used in hospitals and clinics by users thoroughly trained
in the appropriate medical procedures. DYSIS intended operator education/minimum knowledge:
•A physician or a medical professional who is trained in, and qualified to perform, colposcopic procedures
•Language Understanding: English
Permissible Impairments: As applied in regular colposcopic practice
DYSIS Medical provides training on the setup and use of the device.
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.
2.3. Contraindications and Side Effects
There are no specific contraindications for the use of the DYSIS Ultra 2.0 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.

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
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A risk assessment has been performed for the DYSIS Ultra 2.0 Digital Colposcope and all residual risks have been
assessed and reduced to as low as practicably possible. No undesirable side effects from using this device or
acetic acid (acetowhitening process) have been identified.
3. 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 Ultra 2.0 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 Ultra 2.0 Digital Colposcope.
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.
4. Use of the Pseudo-Color Imaging (PCI) feature (DYSISmapTM)
When using the PCI feature, please ensure biopsies have adequate surface area to account for possible image
registration error (movement of the cervix while the patient is undergoing examination) in the pseudo-color
overlay map.
During the dynamic imaging procedure, which is used to generate a pseudo-color 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.
5. Summary of Warnings and Cautions
When using this system, always conduct a thorough colposcopy examination,
identifying and selecting areas for biopsy, before using the PCI feature to
(possibly) select additional biopsy sites. 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.

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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.
Do not use DYSIS Ultra 2.0 Digital Colposcope if it appears to be damaged or broken.
The power cable must always be positioned so as to minimize risk for tripping.
Do NOT position the device in a way that makes it difficult to disconnect the device from the
main power 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 imaging
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 DYSIS Ultra 2.0 Digital Colposcope, make sure it is in optimal condition for use.
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 DYSIS Ultra 2.0 Digital Colposcope, please ensure the touchscreen is folded
above the central processing unit (CPU), and the imaging head arm is folded and locked at the
magnetized joint.
Never use your hands to engage or release the foot brake.
Before moving 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.
DYSIS Ultra 2.0 Digital Colposcope should be positioned on a flat surface and the foot brake
engaged to prevent movement and toppling.

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Examine the functionality of the arm prior to examining a patient and ALWAYS before
proceeding to connect a DYSIS speculum.
Connect only components that are specified in this guide as part of DYSIS Ultra 2.0 Digital
Colposcope or that have been specified as being compatible with DYSIS Ultra 2.0 Digital
Colposcope.
To avoid the risk of electric shock, DYSIS Ultra 2.0 Digital Colposcope should only be connected
to a power supply with protective grounding.
Never attach the DYSIS speculum to the imaging head before inserting it into the vagina.
Do not apply any force on top of the imaging head during an examination or at any other time
(especially if a DYSIS speculum is connected).
Do not apply any force to the speculum connector of the imaging head. The speculum connector
should never be used as a handle to move the device.
Sequence of actions to power up the device:
1. Connect the main power cable to the appropriate outlet.
2. Press the green power button.
3. The computing unit will power up and the software application will start.
Sequence of actions to power down the device:
1. Press the SHUT DOWN button (using the touchscreen) from the left panel. DYSIS Ultra 2.0
Digital Colposcope will shut down automatically.
2. To avoid power consumption when idle, turn the green power button to the OFF position
on the base after the unit has completely shut down.
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 has 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 sterilize any part of the
device.
If the device is accidentally contaminated during an exam, use the indicated disinfecting solution
to clean based upon the contamination. Before disinfecting, the device needs to be powered
down and the power cables should be disconnected.
Wear the proper Personal Protective Equipment (PPE) when disinfecting any part of the device.

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(This Caution Symbol Applies to the Safety Cautions Below)
Do not stare directly at the light source in the imaging 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 injury to the user/patient.
To ensure optimaloperation and safety, users should not remove anyof the connectors on DYSIS
Ultra 2.0 Digital Colposcope.
When using the acetic acid applicator, the acetic acid container should not be overfilled.
Do not spray any liquids if the tubes of the spray mechanism have been disconnected or
detached.
The DYSISmapTM is not meant to replace conventional colposcopic assessment and decisions
regarding biopsy treatment or diagnosis. The assessment of acetowhitening should be based on
visual inspection of the entire set of the acetowhitening characteristics. The DYSISmap reflects
a subset of them.
When using different concentrations of acetic acid, the acetowhitening characteristics may
change and consequently the corresponding color coding of the DYSISmap to certain degrees of
acetowhitening.
When adjusting the image brightness, the user should view the monitor directly and not from
the side or from below, as this may distort the perception of the color and brightness.
Before a DYSISmap measurement, check for 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 minimized.
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 marking.
Access to the database is restricted to unregistered users.
The “Required” 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 formatted to a FAT32 file format.

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In addition to the device label, the following warning labels are found on DYSIS Ultra 2.0 Digital Colposcope or
within this document:
The disposable speculum is a Type-B applied part
that provides protection against electric shock.
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.
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.

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6. Location of Product Labels
The product label (containing the device name, serial number, DYSIS Ultra 2.0 Digital Colposcope legal
manufacturer address and Unique Device Identifier Barcode) and the warning labels are located on the back of
the PC enclosure.
Product and warning labels are included on each device as shown in Fig 1 and 2:
a) DYSIS ULTRA 2.0 product label located on the back of
the device
b) DYSIS ULTRA 2.0 warning label located on the back of
the device
Fig 1: Images of product and warning labels applied to Ultra 2.0 devices.

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a) Do not push (top of pole)
b) Hand crush warning (ARMD)
Fig 2: Location of safety labels on the Ultra 2.0 device.
7. 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 in the USA.
ME Classification –Class II device as it contains an electrical grounding system.
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/EN 60825-1.
DYSIS reusable metal specula are a Type BF applied part and the DYSIS disposable specula are a Type B applied
part per International Electro-technical Commission (IEC 60601-1), according to the type of protection against
electric shock.
DYSIS Ultra 2.0 Digital Colposcope imaging head is not an applied part but could accidentally come in contact
with the patient. The imaging 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. (See Appendix 2)
Mode of operation: DYSIS Ultra 2.0 Digital Colposcope is classified for continuous operation.
8. Environmental Conditions
8.1. Storage
The DYSIS Ultra 2.0 Digital Colposcope should only be stored in environments where the temperature ranges
between 32°F to 122°F (0°C to 50°C) and humidity up to 95% (non-condensing).