DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
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8.2.
Usage
The DYSIS Ultra 2.0 Digital Colposcope should only be operated in environments where the temperature ranges
between 50°F to 104° (10°C to 40°C) and humidity up to 90% (non-condensing).
8.3.
Transportation
During shipping, the DYSIS Ultra 2.0 Digital Colposcope shall withstand a temperature range between 14°F to
122°F (-10°C to 50°C) and humidity range of 5% to 95% (non-condensing).
8.4.
Atmospheric Pressure
There is no impact from atmospheric pressure on the device and it does not require any gases to function.
9.
Usage Restrictions
The 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 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.
The 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 the DYSIS 2.0 Digital Colposcope other than the DYSIS Acetic Acid
applicator and the fuses. The 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 the DYSIS Ultra 2.0 Digital
Colposcope is ON.
Air vents must be kept unobstructed.
Do not sit, lean or step on the DYSIS Ultra 2.0 Digital Colposcope. Do not place any items (such as instruments,
coffee, weights, etc.) on the DYSIS Ultra 2.0 Digital Colposcope. Do not push or pull DYSIS Ultra 2.0 Digital
Colposcope in a way other than outlined in this guide or as instructed by a DYSIS Medical representative for
proper operation.
The DYSIS Ultra 2.0 Digital Colposcope should only be connected to a grounded hospital grade outlet.
