ViroCAP derma

Organization name

Viromed Medical AG

SRN

DE-MF-000047406

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW258

  The Spacer surface may reach temperatures of 55°C. Ensure a safe distance of 0.5cm between Spacer and skin. Reduce contact times as much as possible and below 1 minute to ensure safe contact. Avoid contact especially with areas that are contraindicated.
• CW011

  • Any signs of housing damage, cable defects, or compromised shielding enclosures must be considered potential safety risks, as they may impair both electromagnetic compatibility and electrical safety. In case of any damage or irregularity, please contact technical support before further use. • Operate the ViroCAP only with the specified mains voltage. Failure to do so may result in malfunctions, failure, smoke development or even fire. • Wear disposable gloves when using and cleaning the device for self-protection and to avoid cross-contamination. • Use the ViroCAP derma spacer only for one patient and one treatment area at a time. Otherwise, cross-contamination may occur. • Treatment with ViroCAP derma produces ozone in low concentrations. When used as intended, the legal limits are not exceeded, but the ‘odour threshold’ may be exceeded. The ozone is sufficiently diluted by the ambient air. When used in small rooms and/or with several devices and/or for longer treatment times, ensure adequate ventilation (e.g. by opening windows or doors). Individual sensitivity to ozone varies greatly. When using ViroCAP derma in the presence of people with chronic respiratory diseases, infants and small children, particular attention must be paid to adequate ventilation due to their special sensitivity. • Treatment with ViroCAP derma generates very low levels of UV radiation. Avoid treatment around the eyes. During treatment with ViroCAP derma ozone is produces in low concentrations. Avoid treatment in the area of mouth and nose. • Under no circumstances remove the ViroCAP derma spacer or the plasma module during treatment. • Never use electrically conductive tools to take out the battery.
• CW007

  EUDAMED did not publish a description for this code.
• CW009

  The ViroCAP derma spacer is a single use product in order to avoid cross-contamination.

Primary placement in Germany; available across 1 country total.

Trade name

ViroCAP derma

UDI-DI code

04262518941442

Basic UDI-DI

426251894-ViroCAPderma-G2

Reference / catalog number

144

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

ViroCAP derma is a mobile medical device that generates cold atmospheric plasma. The device has a piezoelectric plasma generator that enables to partly ionize surrounding ambient air due to its high electrical fields, thus providing cold atmospheric plasma in the discharge environment. The reactive oxygen and nitrogen species generated can now reach the injured skin and develop their healing effect. The appropriate spacer helps to focus the reactive species over the area to be treated and maintain a safe distance between the plasma generator and the patient. It also provides a hygienic interface to the treatment area. For treatment, the device is held with the spacer at a slight distance above the area to be treated. After 30 seconds, an acoustic signal indicates that the device can be moved on.

Additional information URL

https://www.viromed.de/

Clinical sizes

No clinical sizes registered for this device.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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This device is not currently linked to any other device.