DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
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25.8.
DYSIS Acetic Acid Applicator
The applicator kit does not come into contact with the patient at any time.
The applicator kit should be purged with acetic acid prior to use.
The acetic acid solution should be labelled and discarded/changed per facility protocol. If daily or periodic
cleaning is required per facility protocol and is not required to be a sterile solution, the acetic acid solution can
be poured out of the acetic acid reservoir and the reservoir rinsed and dried. To rinse the tubing, pour 10 ml
of water into the reservoir. The tubing can be flushed by pulling back and depressing the syringe while holding
a paper towel in front of the diffuser. The bottle should be removed and dried, the tubing should be dried by
depressing the syringe several times to expel any remaining fluid.
The DYSIS Acetic acid applicator should be replaced every 30 days (please see section 25.13).
The DYSIS acetic acid applicator consists of the syringe, the acetic acid reservoir, the luer lock, the spray nozzle
and the silicon tubing. If the local clinical practice is to store and maintain acetic acid in sterile conditions, it is
strongly recommended that the kit is high level disinfected before use. This can be achieved by using a
commercial high-
level disinfection fluid, which should be used according to the manufacturer’s instr
uctions.
Ensure that the high-level disinfection liquid reaches all parts of the kit, by filling the reservoir with the high-
level disinfection liquid and then draw and press the syringe plunger to fill the tubing (repeat until the tubing
is filled and liquid is sprayed from the nozzle). Purge the high-level disinfection fluid from the applicator by
repeating these steps using sterile saline or sterile water until cleared according to manufacturer’s instructions
for rinsing. It is not possible to sterilise the acetic acid applicator kit.
25.9.
Periodic Cleaning and Maintenance
The user should on a monthly basis clean and maintain the DYSIS Ultra 2.0 Digital Colposcope (monitor, base,
optical head, arms, pole etc.) as per cleaning instructions.
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. The DYSIS Ultra 2.0 Digital
Colposcope is below the SELV limits of 50 V ac and therefore does not require any routine electrical testing to
be performed.
25.11.
Connecting an external monitor
The DYSIS Ultra 2.0 Digital Colposcope can be connected to an HDMI monitor.
Connection of an external monitor via the HDMI port is possible, but only if a medical grade isolator is used.
To remove the cover plate, remove one screw at a time, and the cover plate should slide up or down. Having
the DYSIS HDMI port available, the isolator should then be connected directly.
The external monitor should be connected to the isolator.
After having connected the external monitor, on the next DYSIS Ultra 2.0 Digital Colposcope start-up, both
monitors will be functional.