Instructions for Use plasma care® plasma care® spacer
Instruction for Use plasma care and plasma care spacer Table of contents 1 2 3 4 Imprint .............................................................................................................................................. 4 1.1 Imprint ..................................................................................................................................... 4 1.2 Disclaimer ...........................................................................................................
Instruction for Use plasma care and plasma care spacer 9 Cleaning, maintenance and servicing ..................................................................................... 25 9.1 Cleaning and maintenance .............................................................................................. 25 9.1.1 Cleaning of the plasma care® and docking station ................................................. 25 9.1.2 Cleaning of the plasma source unit ................................................
Instruction for Use plasma care and plasma care spacer 1 Imprint 1.1 Imprint © 2019 terraplasma medical GmbH. All rights reserved. This document may not be reproduced in part or fully in any form (print, photocopy or by any other method) for any purpose but personal use without written consent from terraplasma medical GmbH. Nor may this document be processed, multiplied or distributed using electronic systems.
Instruction for Use plasma care and plasma care spacer 2 Notes and symbols 2.1 Read and abide by the manual Before using the plasma care® the manual needs to be read carefully and completely. Reading and following the safety guidelines as well as the manual is compulsory for any use of the device. Non-comliance with the manueal and the safety instructions can lead to damage of the device, serious injuries and may even result in life-threatening situations 2.
Instruction for Use plasma care and plasma care spacer Displays the limits of barometric pressure to which the medical device may be exposed safely. Fragile! Store dry. Protect the product form direct radiation by sun and light Check the battery, displays the current battery charge condition and indicates the charging process. CE-label with the code number of the notified body. Piece of equipment of type BF. Do not reuse.
Instruction for Use plasma care and plasma care spacer 2.3 Warning and safety notes 2.3.1 Starting-up the medical device Only use the plasma care®, after having read and understood the instructions for use in its entirety. Non-compliante usage of the devicedue to disregard of the manual can lead to personal injury or damage to property. ID001 Only use the plasma care® with the specified line voltage. Otherwise disturbances, outages, smoke emission and even fire can occur.
Instruction for Use plasma care and plasma care spacer Only use the plasma care® with the original components and accessories from the manufacturer. ID010 ID011 Do not perform any modifications on the plasma care® without permission of the manufacturer. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Do not open the plasma care® under any circumstances.
Instruction for Use plasma care and plasma care spacer ID020 If non-vital tissue, necrotic tissue, fibrin layers or foreign particles are present in the wound, careful wound bed preparation (using wound rinsing solutions without active components) needs to be performed prior to plasma care® treatment. Otherwise the plasma treatment may not be effective. ID021 Wound rinsing solutions with active components may not be used immediately prior to the treatment with plasma care®.
Instruction for Use plasma care and plasma care spacer ID027 Throughout treatment with the plasma care® ozone is generated at a low concentration. During the intended use of the plasma care® the legal limits for ozone are not exceeded; however, the ozone can be detected by its scent. The ozone is sufficiently diluted by the surrounding air.
Instruction for Use plasma care and plasma care spacer Discard the plasma care® spacer safely in compliance with the applicable regulations for contaminated single-use items. ID034 If dirt remains on the plasma source after cleaning, the dirty plasma source needs to be replaced by a new clean plasma source unit.
Instruction for Use plasma care and plasma care spacer 2.3.5 Unexpected events ID041 When you observe discomfort or an abnormal reaction in a patient, the treatment needs to be stopped immediately. If the adverse event is serious, this needs to be reported to the manufacturer and the responsible authority of the member state, in which user and/or patient live, immediately.
Instruction for Use plasma care and plasma care spacer 3 Intended Use, Indications for Use, Side Effects, Complications, and Contraindications The plasma care® is a medical device for the painless antimicrobial treatment of wounds with cold atmospheric plasma. It is used with an add-on, the plasma care® spacer,i a sterile singleuse spacer. It requires minimal contact with the patient’s wound or intact skin and is operated by healthcare professionals. 3.
Instruction for Use plasma care and plasma care spacer • Wounds without hemostasis • Wounds with exposed inner organs (e.g., during surgery) • Wounds at mucous membranes • Wounds of head and neck area • Children under the age of 12 years 4 Operator and Patient Profiles 4.1 Operator The plasma care® is a medical device that is intended for use in a professional environment. The operators are physicians and other healthcare professionals • in hospitals (e.g.
Instruction for Use plasma care and plasma care spacer 5 Delivery contents The plasma care® is delivered with the following components: plasma care® source unit with removable plasma docking station power supply for the docking station sterile, individually packaged plasma care® spacer (single use only) Instruction for Use IFU plasma care© and plasma care© spacer Copyright: terraplasma medical GmbH Version: 0.1 Date: 26.05.
Instruction for Use plasma care and plasma care spacer 6 Description of the plasma care® 6.1 plasma care® components The plasma care® is composed of the device, its docking station with the power supply and the plasma care® spacer. plasma care® docking station The docking station has two functions: • Safe placement and storage area for the plasma care®. • Recharging of the plasma care® via contactless, inductive energy transfer as soon as the plasma care® is placed in the docking station.
Instruction for Use plasma care and plasma care spacer • • • The integrated safety grid prevents contact of the patient or the operator with the plasma source integrated into the plasma source unit, while it produces plasma. An unambiguous identification of the attached spacer is enabled via an integrated RFID-transponder. After using the spacer, it is marked as “invalid” and cannot be used for any further treatments. In case of an invalid spacer, the plasma care® device cannot be activated.
Instruction for Use plasma care and plasma care spacer Blue flashes: Indicates that a valid spacer is clipped onto the plasma care® and that the preparation period is running. Blue glow: When the preparation period is completed all four plasma ring segments glow steadily and the plasma treatment can be started by exerting pressure on the On / Off button briefly.
Instruction for Use plasma care and plasma care spacer When the plasma care® is placed into the docking station, the battery symbol will alternate between the green, yellow and red glow for as long as the plasma care® is being re-charged. When the plasma care® is fully charged the battery symbol will glow green continuously. Docking station on / off glow The blue control-LED will glow as long as the docking station is plugged-in.
Instruction for Use plasma care and plasma care spacer 4. Place the plasma care® into the docking station. plasma care© docking station 5. When the plasma care® is placed into the docking station and charges, the batteryLED will flash from red, yellow and green. When the plasma care® is fully charged the battery symbol will only flash green. 6. For the very first use, the plasma care® should be fully charged. This can take up to 3 hours.
Instruction for Use plasma care and plasma care spacer 8 Treatment The treatment with the plasma care® is carried out in treatments of one minute each. The complete treatment of a single area must not exceed three sequential treatments and thus three minutes. A treatment-free interval of at least 12 hours should elapse before another plasma treatment is performed.
Instruction for Use plasma care and plasma care spacer 4. As soon as the blue plasma ring glows permanently, the plasma care® is ready for treatment. Place the plasma care® gently onto the wound to be treated with the open side of the spacer. The frame of the spacer should lie flat on the wound or the skin such that a closed volume is created. By pressing the on / off button briefly the plasma treatment is started.
Instruction for Use plasma care and plasma care spacer If the plasma ring glows red permanently, a device malfunction has occurred. Note: Perform the steps described in chapter 10.4 Troubleshooting. If the plasma ring continues to glow red permanently, please contact the customer service. Ensure that the plasma care® and in particular the plasma source is not contaminated, smutched or damaged.
Instruction for Use plasma care and plasma care spacer 8.2.2 Removing the spacer 1. Remove the spacer as depicted. This works best using the thumb and middle finger. 2. Remove or rather push off the spacer at the clip with the thumb and stabilize it with the middle finger to not let it fall. Before each use of a spacer, make sure that the sterile packaging is not damaged or has not already been opened prior to usage of the spacer. ID009 8.
Instruction for Use plasma care and plasma care spacer ID020 If non-vital tissue, necrotic tissue, fibrin layers or foreign particles are present in the wound, careful wound bed preparation (using wound rinsing solutions without active components) needs to be performed prior to plasma care® treatment. Otherwise the plasma treatment may not be effective. Generally a wound is treated with a wet-to-dry dressing. First, the wound bed is irrigated and topical antiseptics are applied.
Instruction for Use plasma care and plasma care spacer If neccessary, remove rough dirt and deposits thoroughly. For this purpose, use a lint-free cloth, warm water and a common detergent and wipe down the surface without touching the plasma source or its mesh. Do not use scouring agents or aggressive detergents. Allow the device to dry completely. 2. Disinfection: • The disinfection of the plasma care® must be performed using wipe disinfection.
Instruction for Use plasma care and plasma care spacer Cleaning the plasma source unit: 1. The disinfection of the plasma care® must be performed using wipe disinfection. 2. Use a lintless cloth or paper cloth for disinfection that is moistened very well with disinfectant; Bacillol® AF Tissues (BODE Chemie GmbH) or Pursept® A Xpress wipes (Schülke & Mayr GmbH). 3. Dab the plasma source unit on the surface. Take care to not leave paper or cloth particles behind on the mesh of the plasma source.
Instruction for Use plasma care and plasma care spacer Recommended disinfection agents: • • Bacillol® AF Tissues (BODE Chemie GmbH) Pursept® A Xpress wipes (Schülke & Mayr GmbH) If dirt remains on the plasma source after cleaning, the dirty plasma source unit needs to be replaced by a new clean plasma source unit.
Instruction for Use plasma care and plasma care spacer 9.2 Service The plasma care® needs to be returned to the manufacturer once a year for servicing. Please inform the manufacturer in writing prior to each return (e.g. via support@terraplasma-medical.com). Please supply the serial number for the plasma care® and request a return number (RMA-number). Please clean and disinfect the plasma care® prior to each return as described in chapter 9.1 cleaning and maintenance.
Instruction for Use plasma care and plasma care spacer 10 Orientation, training and support 10.1 Orientation Orientation regarding the intended use is provided upon delivery of the plasma care®. It can be provided in person or by telephone. 10.2 Training Training in how to use the plasma care® that extends beyond usual orientation is offered by terraplasma medical GmbH in the form of: • • • Personal training on site by an employee of terraplasma medical GmbH.
Instruction for Use plasma care and plasma care spacer • If cleaning in due form is insufficient, exchange the plasma source unit and use a new plasma source unit. Check the plasma care®, especially the plasma source unit and the plasma source for damage such as cracks or fissures: • In case of damage, the plasma care® needs to be returned to the manufacturer for servicing and repair.
Instruction for Use plasma care and plasma care spacer The plasma care® can be stored at a relative humidity between 15% and 90% RH. The plasma care® spacer can be stored at temperatures between -20°C and +55°C until the end of its use-by date. The plasma care® spacer must not be used after its use-by date is passed. The plasma care® spacer can be stored at a relative humidity of 20% and 75% RH. The plasma care® and the plasma care® spacer can be stored at atmospheric pressure between 700 hPa and 1060 hPa.
Instruction for Use plasma care and plasma care spacer The plasma care® spacer must not be used after its use-by date is passed. Do not sterilize again At full charge the capacity of the battery allows at least 120 treatments to be carried out. The re-chargeable battery has a residual capacity of at least 65% after 300 complete charging cycles. 13 Disposal The plasma care® needs to be discarded via a separate collection of electric and electronic appliances.
Instruction for Use plasma care and plasma care spacer 14 Device Labeling terraplasma medical GmbH Parkring 32 85748 Garching b. München (01) 4260644540010 (11) 2019 (21) 55000001A Manufacturing date Caution: U.S. Federal law restricts this device to sale by or on order of a physician Note: The manufacturing date can be found on the backside of the plasma care® next to the DataMatrixCode after the indicator number (11).
Instruction for Use plasma care and plasma care spacer NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radi-ate radio frequency energy and, if not in-stalled and used in accordance with the instructions, may cause harmful interference to radio communications.
Instruction for Use plasma care and plasma care spacer 17 EMC The following table shows the compliance with the respective standards regarding electromagnetic emission and immunity.
Instruction for Use plasma care and plasma care spacer The following table shows the compliance with the respective standards regarding immunity against high frequency wireless communication devices.
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