ActivCell Group Effectum Medical ActivCellpen User Manual
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ActivCell Group Effectum Medical ActivCellpen User Manual

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User manual
English
developed and manufactured
in Switzerland

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Summary of Contents for ActivCell Group Effectum Medical ActivCellpen

  • Page 1 User manual English developed and manufactured in Switzerland...

  • Page 2: Table Of Contents

    Table of Contents Introduction Cleaning and Storage General Use Information Troubleshooting Mode of Action Intended Use Technical Data Indication Contraindications Detailed Safety Information 10.1 Electromagnetic emission and immunity Warnings 10.2 Emission of Radiation Key to symbols General warnings and precautions Compliance 11.1 IEC 60601 The ActivCellpen...

  • Page 3: Introduction

    The ActivCellpen is developed and manufactured in Switzerland. ActivCellpen ® is a registered trademark of ActivCell Group AG. 2.2 Intended Use The ActivCellpen is intended to reduce microorganisms on the skin or wound and thus promote wound healing.

  • Page 4: Contraindications

    2 General Use Information 3 Warnings 2.4 Contraindications 3.1 Key to symbols The use of the ActivCellpen is contraindicated for: Warning Precaution – Craniofacial procedures, including eyes and ears – Dental procedures Failure to comply with the warning Indicates a low-risk hazard which, –...
  • Page 5 – The ActivCellpen must not be operated outside the temperature range of 5 – 25 ° C. – Repairs may only be performed by a specialist authorized by ActivCell Group. Contact your supplier for repair needs. ActivCellpen User Manual V4...

  • Page 6: The Activcellpen

    4 The ActivCellpen 4.1 Components Device Component Article No. Warning ActivCellpen (housing with electronic components) ACT-100.100 The material of the electrode tip is glass. Caution needs to be taken as the ActivCellpen Charger ACT-100.310 electrode may break during handling or maintenance, or when the device falls to the ground.

  • Page 7: Setting Up Operation Of The Activcellpen

    – Before using the charger, check that the voltage indicated on the charger matches the regional mains voltage. Before using the ActivCellpen for the first time, ActivCell Group recommends mak- ing sure the batteries are fully charged and to conduct a functional test before starting treatment as described in section 5.3.

  • Page 8: Assembly Of The Activcellpen

    Precaution If the functional test is not successful, refer to chapter 8, Troubleshooting, to determine which measures you can take, or get in touch with your supplier or a contact person authorized by ActivCell Group ® ActivCellpen User Manual V4...

  • Page 9: Led Codes

    5 Setting up Operation of the ActivCellpen 6 Use of the ActivCellpen 5.4 LED Codes 6.1 Device Settings 5.4.1 Charger When a battery with low charging level is inserted, the control LED is flashing green. A solid green control LED indicates that the battery is charged and ready for insertion into the ActivCellpen.

  • Page 10: Application Of The Device

    6 Use of the ActivCellpen 6.2 Application of the device Assemble and switch on the device as described in section 5.2. Hold the ActivCellpen with the handle (with the two switches) in your fist as Precaution shown in the pictures below (both options are acceptable). Do not apply pressure to the wound.

  • Page 11: Use Of The Two Electrodes

    6 Use of the ActivCellpen 6.3 Use of the two electrodes A power per surface area of 14 mW/cm is sufficient to achieve the required antimi- crobial efficacy to reduce microorganisms in the wound. 6.3.1 The straight electrode It is recommended to store the electrodes in the case between treatments . 6.4 Use recommendations Warning The straight electrode can be applied at a convenient 45°...

  • Page 12: Cleaning And Storage

    6 Use of the ActivCellpen 7 Cleaning and Storage The following settings are generally recommended: Precaution – Typically, the highest setting combination with amplitude 9 and 100 impulses/s shall be used. – The device must be assembled (electrode and battery inserted) and switched off before disinfection.
  • Page 13 7 Cleaning and Storage – Wipe the electrode with the moist wipe and make sure the wound-contacting Note glass part of the electrode has been fully covered. Special attention is rec- ommended to ensure full wetting of the wound contact surface of the disc –...

  • Page 14: Troubleshooting

    8 Troubleshooting 9 Technical Data The following problems can be addressed by the user: ActivCellpen Protection against electric shock – Max. output voltage 25 kVAC – Type BF applied part (60601-1), inter- If the LED does not light up when the device is switched on (turn the amplitude –...

  • Page 15: Detailed Safety Information

    10 Detailed Safety Information 10.1 Electromagnetic emission and immunity Note This ActivCellpen is intended for use in the electromagnetic environment specified below. The user of the device must ensure that the device is used in the specified The emissions characteristics of this device make it suitable for use in industrial environment.
  • Page 16 10 Detailed Safety Information Electromagnetic Immunity Immunity Test Test level according to IEC 60601-1-2 Compliance Level Electromagnetic Environment – Clues Electrostatic discharge (ESD) ±8kV contact ±8kV contact The floor should be made of wood, con- IEC 61000-4-2 ±2, ±4, ±8, ±15kV air ±2, ±4, ±8, ±15kV air crete, or ceramic tiles.
  • Page 17 10 Detailed Safety Information Electromagnetic Immunity Immunity Test Test level according to IEC 60601-1-2 Compliance Level Electromagnetic Environment – Clues Radiated RF 3 V/m 10 V/m IEC 61000-4-3 80MHz to 2.7GHz 80MHz to 6.0Hz Proximity fields from RF wireless 385MHz: 27V/m @ 18 Hz pulse modula- 385MHz: 27V/m @ 18 Hz pulse modula- communications equipment tion...

  • Page 18: Emission Of Radiation

    10 Detailed Safety Information 10.2 Emission of Radiation The risk assessment for a user depends on the frequency with which the ActivCell- pen is used. The ActivCellpen emits low levels of UV radiation in the UV-A, -B and -C range. The risks derived from UV radiation to the patient or user have been determined as In case a user treats 10 patients per day, the resulting exposure time is 10 ×...

  • Page 19: Compliance

    12.3 Product-Related Questions 12.4 Support and Distribution Regulation (EU) 2017/745 of the European Parliament and of the EU Council of 5 April 2017 on Medical Devices ActivCell Group AG Refer to the ActivCell Group website Luzernerstrasse 20 (www.activcellgroup.com) CH-6295 Mosen www.activcellgroup.com E-Mail: info@activcellgroup.com...

  • Page 20: Warranty

    13 Warranty 14 Symbols on Labels The General Terms and Conditions of ActivCell Group AG apply at the time of pur- Manufacturer chase. Conformité Européenne – Pen: 2 years, covering material, functional and manufacturing defects – Electrode: 2 years from the date of purchase Medical Device –...
  • Page 21 Effectum Medical AG Kirchgasse 11 CH-4600 Olten Phone: +41 77 493 72 72 info@effectummedical.com www.effectummedical.com MED-RAS GmbH ActivCell Group AG Eichenallee 8H Luzernerstrasse 20 D-21112 Wohltorf CH-6295 Mosen Phone: +49 4104 99 44 44-0 Phone: +41 41 924 11 88 info@medras.de...

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