Help centre for your RUCK ViroCap Cold Plasma

RUCK ViroCap Cold Plasma – One-click support

In our RUCK ViroCap Cold Plasma Help Centre, you’ll find step-by-step instructions, explanatory videos on how to use the device, troubleshooting guidance, as well as suitable spare parts and accessories.

Step by step: How to use cold plasma correctly

Operating the equipment

Replacing the spacer

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Replacing the plasma module

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Reset the cold plasma device

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Instructions for Use RUCK ViroCap Cold Plasma

Product information

Should I read the instructions for use before first using the device?

Yes. Please only use the RUCK ViroCap cold plasma after you have fully read the instructions for use. The Quick-Start Guide does not replace the instructions for use; it serves only as a brief overview for the first steps.

What is the RUCK ViroCap cold plasma used for?

The RUCK ViroCap cold plasma is a mobile medical device for reducing bacteria, viruses and fungi in dermatological skin conditions by means of cold atmospheric plasma. It is used in combination with the appropriate single-use spacer by medical professionals.

What does the RUCK ViroCap cold plasma system consist of?

The system consists of the handset, the plasma module, a single-use spacer as well as the charging station with power supply unit. The components can be safely stored and transported in the case.

Can the device be charged with a single-use spacer attached?

No. Please remove the single-use spacer before charging. The handset cannot be charged with a single-use spacer attached, and the spacer becomes unusable.

How long does the battery last on a full charge?

On a full charge, the battery enables at least 35 minutes of active plasma generation. If this duration decreases significantly, the battery should be replaced.

What is the service life of the system?

The handset and the plasma module have a service life of at least two years from first use, provided the device is used and maintained in accordance with the instructions for use. The plasma module is replaceable and can be purchased separately.

Usage notes

Who is permitted to use the RUCK ViroCap cold plasma?

The device is intended for professional use. Users are physicians and medical professionals — for example in clinics, doctors' surgeries, podiatric practices, care facilities or in mobile use. Before use, all users must read the instructions for use carefully and familiarise themselves with the device.

Which patients is the application intended for?

The application is intended for patients with dermatological skin conditions as well as superficial skin and nail disorders in the podiatric field of use. Patients should be at least 12 years of age.

May the RUCK ViroCap cold plasma be used on children?

Children under 12 years of age must not be treated with the RUCK ViroCap cold plasma. Please refer to the information in the instructions for use.

Which areas should not be treated?

The treatment area must not overlap with the openings of the mouth, nose or eyes. In particular, avoid treatment around the eyes and around the mouth and nose.

Which fields of application are intended in the podiatric setting?

In the podiatric setting, the field of application in particular covers the skin of the foot, toes, spaces between the toes, toenail surface, nail fold, nail bed area and the nail itself.

Charging & battery

How do I charge the device before first use?

Connect the charging station to the mains supply using the power supply unit and place the handset without spacer into the charging station. The charging contacts connect automatically. Before first use, the device should be fully charged; this process can take up to three hours.

Which power supply unit may be used?

Only use the manufacturer's original power supply unit, TDK WMM30CN120-00E-502. The use of other power supply units is not permitted.

Single-use spacer

What is a single-use spacer and what is it used for?

The spacer is a single-use item inserted into the front of the handset. It ensures a safe distance between the plasma module and the treatment area, protects against unintentional contact with the plasma source and forms a hygienic interface with the treatment area.

Can I reuse a single-use spacer?

No. The spacer is a single-use item and may only be used for one patient and one treatment area. Reuse is technically not possible and can additionally lead to cross-contamination.

How do I attach the single-use spacer correctly?

Check the single-use spacer for damage before use. Press it at the intended grip recesses and carefully insert it into the front section of the handset until the snap hooks engage. Do not apply excessive force.

How do I remove the single-use spacer after treatment?

After treatment, pull the single-use spacer straight out of the housing and dispose of it in accordance with the applicable regulations. Please do not press the side release buttons of the plasma module while doing so.

Why must I not press the side buttons when removing the single-use spacer?

The side buttons release the plasma module. If they are pressed while removing the spacer, the sensitive plasma source can detach.

How many applications are possible with a single-use spacer?

Once attached, up to 45 applications per battery charge are possible with the spacer. Within this period, up to 20 applications of 1 minute or 10 applications of 2 minutes each are possible. After this period has elapsed or after the maximum number of applications has been reached, the single-use spacer is automatically deactivated.

Device operation & treatment

Which application duration can I set?

The maximum application duration of 20 minutes in total can be set in intervals of 1 or 2 minutes. The active plasma generation is started and stopped with the start/stop button.

Can I interrupt the application?

Yes. The application can be interrupted at any time by pressing the start/stop button. The device also stops plasma generation automatically once the set maximum application duration has elapsed.

Why are 45 applications quoted in one place and 35 minutes of battery life in another?

The two figures refer to different states of the battery: 45 applications, i.e. approx. 45 minutes, describe the performance of a new, fully charged battery. This is the minimum requirement for a new device. 35 minutes of battery life refer to the minimum performance at the end of the battery's lifetime. If operating time drops significantly below this value, the battery should be replaced. In practice, a new battery often even achieves a longer runtime than the stated 45 minutes after a few charging cycles. In short: 45 minutes = minimum runtime of a new battery 35 minutes = minimum runtime of an aged battery before it needs to be replaced

How do I hold the device during treatment?

Hold the handset steady and at a slight distance above the area to be treated. It does not matter whether the device is held vertically, horizontally, with the outlet upwards or downwards. After 30 seconds, a brief acoustic signal indicates that the device can be moved to an adjacent area when treating skin. For nail treatments, the device can remain on a nail for the full 2 minutes, because the keratin layers there are thicker and a longer concentration of cold plasma is helpful.

Why does an acoustic signal sound during the application?

After 30 seconds, a brief acoustic signal indicates that the device can be moved to the next treatment area. This supports a uniform treatment of larger areas.

Do I need to wear gloves during the application?

We recommend wearing gloves at all times when using and cleaning the device. This serves your own protection and helps to prevent cross-contamination.

Does the room need to be ventilated during the application?

Yes. Make sure the working area is sufficiently ventilated. During treatment, ozone is produced in low concentrations. In small rooms, with longer treatment times or with several devices in use, particular attention should be paid to sufficient ventilation — for example by opening windows or doors.

Can the single-use spacer become warm during the application?

Yes. The surface of the single-use spacer can reach temperatures of up to 55 °C. Therefore, keep a slight distance between the single-use spacer and the skin.

What must I check before every application?

Before every use, check the device and all associated components for damage. This includes in particular the handset, plasma module, charging station and power supply unit. In the event of damage or irregularities, please stop using the device and contact technical support.

Does the RUCK ViroCap cold plasma have an on/off switch?

No. The device does not have a classical on/off switch. When not in use, it switches to power-saving mode after 20 minutes. To exit power-saving mode, press the start/stop button or attach a new spacer.

Is UV radiation produced during the application?

Small amounts of UV radiation are produced during treatment. Avoid treatment around the eyes.

May I remove the spacer or the plasma module during treatment?

No. Under no circumstances remove the spacer or the plasma module during treatment.

Troubleshooting

What do I do if the device is defective or the display appears frozen?

Stop using the device if it is defective — for example if the display is defective or frozen. If the display is frozen, you can hold down both arrow buttons to restart the device. If the problem cannot be resolved, please contact customer service.

What does it mean if no single-use spacer is recognised?

If no single-use spacer is attached, or the single-use spacer is invalid, plasma generation is not possible. Please attach a new, suitable single-use spacer. Note: a spacer that has already been used is recognised as invalid by the device.

What can I do if the device is not charging?

First check whether the charging station is connected to the mains and whether the device is correctly seated in the charging station. Also remove the single-use spacer, as the device cannot be charged while a spacer is attached. Visible dirt on the charging contacts can be carefully removed. If the problem persists, please contact customer service.

Cleaning & hygiene

How do I clean and disinfect the device after use?

First remove and dispose of the single-use spacer. Clean the accessible surfaces of the handset with a damp single-use wipe, thoroughly dry all cleaned parts and disinfect the accessible surfaces with a suitable disinfectant wipe. Observe the contact time, concentration and temperature specified by the manufacturer of the disinfectant.

May I submerge the handset or plasma module in liquid?

No. Do not rinse the handset and plasma module with liquids and do not immerse them in liquids. Also avoid wet cleaning; spray disinfection should likewise not be used.

May I clean the piezo element?

No. Do not clean the piezo element (plasma module). Only clean the outer, accessible surfaces in accordance with the instructions for use.

How is the used single-use spacer disposed of?

After use, safely dispose of the single-use spacer in accordance with the applicable regulations for contaminated waste. After use, the single-use spacer falls under waste code AS 18 01 03 and must be disposed of in accordance with the corresponding requirements.

Storage & transport

How do I store the RUCK ViroCap cold plasma correctly?

After use or when not in use, place the handset in the charging station. Remove the single-use spacer beforehand. Please note that the plasma source is made of sensitive ceramic and can be damaged if dropped.

Under which conditions may the device be operated?

The device may be operated at temperatures between +10 °C and +30 °C, at a relative humidity of 15 % to 80 % without condensation, at an air pressure of 800 hPa to 1060 hPa and at altitudes of no more than 2000 m above sea level.

What do I need to observe after transport or storage?

Before commissioning after transport or storage, the device must reach the permitted operating conditions. At an ambient temperature of 20 °C, the device needs at least 5 minutes to adapt from the highest or lowest storage or transport temperature to the permitted operating temperature.

Service

Where can I order spare parts or single-use items?

Spare parts and single-use items can be requested from HELLMUT RUCK GmbH. Contact: Daimlerstraße 23, 75305 Neuenbürg, telephone +49 (0)7082 944 20, e-mail kontakt@hellmut-ruck.de.

Safety

What do I do in the event of a serious incident?

If a serious incident occurs in connection with the use of the product, it must be reported without delay to the manufacturer and to the competent authority of the member state in which the user and/or patient is established. Please include a description of the event, the device identification and the contact details of the reporting person or facility. Ventilate the room and remain calm.

Whom can I contact if a problem cannot be resolved?

If a problem cannot be resolved using the measures described in the instructions for use, please contact HELLMUT RUCK GmbH on +49 (0)7082 944 20 or by e-mail at kontakt@hellmut-ruck.de.

Legal & approval

Is a V-NISSG certificate of competence required for RUCK ViroCap cold plasma in Switzerland?

No. The RUCK ViroCap cold plasma is approved as a medical device and is used in accordance with its medical intended purpose. Medical devices do not fall under the Swiss Ordinance on Protection from Non-Ionising Radiation and Sound Hazards (V-NISSG). Therefore, no V-NISSG certificate of competence is required for the intended use of the RUCK ViroCap cold plasma. Note: This is subject to the device being used in accordance with its approved medical intended purpose and the manufacturer's specifications.

Is a certificate of expertise under the NISV required for RUCK ViroCap cold plasma in Germany?

No. The RUCK ViroCap cold plasma is approved as a medical device and is used in accordance with its medical intended purpose. The requirements of the NISV apply to certain applications of non-ionising radiation for cosmetic or other non-medical purposes. Medical devices used within the scope of their approved medical intended purpose do not fall under these expertise requirements of the NISV. Note: This is subject to the device being used in accordance with its approved medical intended purpose and the manufacturer's specifications.