2AVYK-1000plasma care

Instructions for Use plasma care® plasma care® spacer Instruction for Use plasma care and plasma care spacer IFU plasma care© and plasma care© spacer Version: 0.1 Date: 26.05.2020 Copyright: terraplasma medical GmbH Page 2/38 Table of contents 1 Imprint .............................................................................................................................................. 4 1.1 Imprint ..................................................................................................................................... 4 1.2 Disclaimer ............................................................................................................................... 4 1.3 Information on the document ............................................................................................. 4 2 Notes and symbols ......................................................................................................................... 5 2.1 Read and abide by the manual ......................................................................................... 5 2.2 Symbols ................................................................................................................................... 5 2.3 Warning and safety notes .................................................................................................... 7 2.3.1 Starting-up the medical device ...................................................................................... 7 2.3.2 Treatment and operation ................................................................................................. 8 2.3.3 Cleaning, maintenance and servicing ........................................................................ 10 2.3.4 Medical device malfunction ......................................................................................... 11 2.3.5 Unexpected events ........................................................................................................ 12 2.3.6 Performance characteristics.......................................................................................... 12 3 Intended Use, Indications for Use, Side Effects, Complications, and Contraindications .... 13 3.1 Intended use ........................................................................................................................ 13 3.2 plasma care® is adjunctive therapy ................................................................................ 13 3.3 Indications for Use ............................................................................................................... 13 3.4 Side effects / Contraindications ........................................................................................ 13 4 Operator and Patient Profiles ..................................................................................................... 14 4.1 Operator ............................................................................................................................... 14 4.2 Patient Profile ....................................................................................................................... 14 5 Delivery contents ......................................................................................................................... 15 6 Description of the plasma care® ............................................................................................... 16 6.1 plasma care® components ............................................................................................... 16 6.2 plasma care® user interface ............................................................................................. 16 6.3 plasma care® spacer ......................................................................................................... 16 6.4 User interface ....................................................................................................................... 17 7 Starting the plasma care® .......................................................................................................... 19 8 Treatment ...................................................................................................................................... 21 8.1 Performing a treatment with the plasma care® ............................................................. 21 8.2 Attaching and removing the spacer ................................................................................ 23 8.2.1 Attaching the spacer ..................................................................................................... 23 8.2.2 Removing the spacer ..................................................................................................... 24 8.3 Treating wounds with the plasma care® ......................................................................... 24 Adjunctive use of the plasma care® for decontamination .............................................. 24 8.3.1 ................................................................................................................................................ 24 8.3.2 Techniques for larger wounds ........................................................................................ 25 Instruction for Use plasma care and plasma care spacer IFU plasma care© and plasma care© spacer Version: 0.1 Date: 26.05.2020 Copyright: terraplasma medical GmbH Page 3/38 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 ............................................................................. 26 9.1.3 Storage ...................................................…

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terraplasma medical GmbH Amtsgericht München HRB 224846 USt-Id Nr.: DE 305938516 Geschäftsführer: P. Speidel, J. Kirsch Kontakt T +49 89 5880 553-0 F +49 89 5880 553-99 [email protected] Hypovereinsbank München IBAN DE50700202700015616435 BIC HYVEDEMMXXX www.terraplasma-medical.com terraplasma medical GmbH, Parkring 32, D-85748 Garching MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 USA Date: 26.02.2020 RE: LETTER OF AGENT AUTHORIZATION To Whom It May Concern: We, the undersigned, hereby authorize Marjan Mak at SIQ Ljubljana to act on our behalf in all matters relating to application for equipment authorization, including the signing of all docu- ments relating to these matters. We also hereby certify that no party to the application authorized hereunder is subject to the denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C.853(a). This agreement expires one year from the current date. Sincerely, terraplasma medical GmbH Jens Kirsch, CEO Parkring 32 D-85748 Garching Tel: +49 89 5880 553 0 Fax: +49 89 5880 553 99 [email protected] www.terraplasma-medical.com Ihr Kontakt: Jens Kirsch E-Mail: [email protected]

terraplasma medical GmbH Amtsgericht München HRB 224846 USt-Id Nr.: DE 305938516 Geschäftsführer: P. Speidel, J. Kirsch Kontakt T +49 89 5880 553-0 F +49 89 5880 553-99 [email protected] Hypovereinsbank München IBAN DE50700202700015616435 BIC HYVEDEMMXXX www.terraplasma-medical.com terraplasma medical GmbH, Parkring 32, D-85748 Garching MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 USA Date: 19.05.2020 RE: CONFIDENTIALITY REQUEST FOR PLASMA CARE To Whom It May Concern: This letter serves as an official request for confidentiality under sections 0.457 and 0.459 of CFR 47. We have requested that the (1)Block Diagram/Mechanical Drawings (2)Schematics/PCB Layouts (3)Theory of Operation/Technical Description (4)Parts Lists/BOM required to be submitted with this application be permanently withheld from public review. These documents contain detailed system and equipment description and related information about the product which terraplasma medical GmbH considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, terraplasma medical GmbH con- siders that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Please contact me if there is any information you may need. Sincerely, terraplasma medical GmbH Jens Kirsch, CEO Parkring 32 D-85748 Garching Tel: +49 89 5880 553 0 Fax: +49 89 5880 553 99 [email protected] www.terraplasma-medical.com Ihr Kontakt: Jens Kirsch E-Mail: [email protected]

SIQ Ljubljana, Tržaška cesta 2, SI-1000 Ljubljana, Slovenia T +386 1 4778 100, F +386 1 4778 444, [email protected], www.siq.si External photos Project file: C20191901 Date: 2019-07-22 Pages: 4 Product: plasma care device and charging station - Transceiver Type reference: plasma care Page: 2 (4) Figure 1 Figure 2 Page: 3 (4) Figure 3 Figure 4 Page: 4 (4) Figure 5 Figure 6

statisch fortlaufende Seriennummer Projektnummer GTIN = UDI GS1 DataMatrix Code20x20: (01)4260644540010(11)2019(21)55000001A 6mm x 6mm Herstellungsdatum BESCHREIBUNGÄNDERUNGDATUM DATUMSIGNATURNAME GEPRÜFT GEZEICHNET WERKSTÜCKKANTEN Ditabis AG Parkring 32 85748 Garching b. München ISO 2768-1 mH OBERFLÄCHE: ALLGEMEINTOLERANZEN: WERKSTOFF: BENENNUNG: ZEICHNUNGSNR. MASSSTAB: 1:2 BLATT 1 VON 1 A4 GEWICHT: 550091101_1001_Body_bedru ckt_gelasert_FCC Tampondruck RAL 5005 Signalblau Laserbeschriftung ArtikelNr.: 550091101 Unger 25.03.2020 Wunderl 25.03.2020 AA BB CC DD EE FF 4 4 3 3 2 2 1 1

SIQ Ljubljana, Tržaška cesta 2, SI-1000 Ljubljana, Slovenia T +386 1 4778 100, F +386 1 4778 444, [email protected], www.siq.si Internal photos Project file: C20191901 Date: 2019-07-22 Pages: 8 Product: plasma care device and charging station - Transceiver Type reference: plasma care Page: 2 (8) Figure 1 Page: 3 (8) Figure 2 Page: 4 (8) Figure 3 Figure 4 Page: 5 (8) Figure 5 Figure 6 Page: 6 (8) Figure 7 Figure 8 Page: 7 (8) Figure 9 Figure 10 Page: 8 (8) Figure 11

SIQ Ljubljana, Mašera – Spasićeva 10, SI-1000Ljubljana, Slovenia T +386 1 4778 100, F +386 1 4778 444, [email protected], www.siq.si TN405E - 0 2 Test report Number: T251-0603/19 Project file: C20191901 Date: 2019-08-30 Pages: 49 Product: plasma care device - Transceiver Type reference: plasma care Ratings: plasma care: 7,2 Vdc (battery powered) Protection class: III Trademark: plasma care ® Applicant: terraplasma medical GmbH Parkring 32, DE-85748 Garching, Germany Manufacturer: terraplasma medical GmbH Parkring 32, DE-85748 Garching, Germany Place of manufacture: DITABIS Digital Biomedical Imaging System AG Freiburger Str. 3, DE-75179 Pforzheim, Germany Summary of testing Testing method: 47 CFR Part 15, Subpart C Testing location: SIQ Ljubljana, Mašera-Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia Remarks: Date of receipt of test items: 2019-03-21 Number of items tested: 1 Date of performance of tests: 2019-07-16 - 2019-08-23 The test results presented in this report relate only to the items tested. The product complies with the requirements of the testing methods. / Tested by: Luka Cvajnar Approved by: Marjan Mak The report shall not be reproduced except in full. T251-0603/19 Page: 2 (49) CONTENTS page 1 GENERAL 3 1.1 EQUIPMENT UNDER TEST 3 1.2 ANTENNA REQUIREMENTS (§15.203) 4 1.3 ANSI C63.4 SUBPART SELECTION 5 1.4 CLASS STATEMENT REQUIREMENTS 5 1.5 OCCUPIED BANDWIDTH MEASUREMENT 5 1.6 QUASI-PEAK DETECTOR 5 1.7 PEAK, RMS, AND AVERAGE DETECTORS 5 2 LIMITS 6 2.1 SUBPART C: INTENTIONAL RADIATORS 6 3 ALL TEST EQUIPMENT AND THEIR DESCRIPTION 7 3.1 GENERAL INFORMATION 7 3.2 OTHER INSTRUMENT INFORMATION AND AUXILIARY EQUIPMENT 8 4 TEST SUMMARY 28 4.1 OPERATING VOLTAGES/FREQUENCIES USED FOR TESTING 28 5 CONVERSION FACTORS AND ALL OTHER FORMULAS 29 6 EMISSION TESTS 30 6.1 RESTRICTED BANDS OF OPERATION (§15.205 OF FCC 47 CRF 15) 30 6.2 CONDUCTED EMISSION MEASUREMENT (§15.207 OF FCC 47 CRF 15) 31 6.3 RADIATED EMISSION MEASUREMENT (§15.209 OF FCC 47 CRF 15) 32 6.4 BANDWIDTH OF THE EMISSION (§15.215) 41 6.5 SPECTRUM MASK (§15.225 (A)-(D) OF FCC 47 CRF 15) 45 6.6 FREQUENCY TOLERANCE OF THE CARRIER SIGNAL (§15.225 (E)) 48 T251-0603/19 Page: 3 (49) 1 GENERAL History sheet Date Report No. Change Revision 2019-07-22 T251-0603/19 Initial Test Report issued. -- Environmental conditions: Ambient temperature: 15C to 35C Relative humidity: 30% to 60% Atmospheric pressure: 860 mbar to 1060 mbar 1.1 Equipment under test plasma care device - Transceiver Type: plasma care FCC ID: 2AVYK-1000 Equipment marking plate (The artwork below may be only a draft. The use of certification marks on a product must be authorized by the respective NCBs that own these marks.) T251-0603/19 Page: 4 (49) 1.1.1 General product information Product plasma care device - Transceiver Type / Model plasma care Supply voltage of transmitter 7 Vdc (battery powered) Operating frequency 13,56 MHz Number of channels 1 Antenna type Pulse W7001 Modulation type ASK Hardware version V3.0 Software version V1.1 Device for wound treatment with cold atmospheric plasma. 1.2 Antenna requirements (§15.203) Requirement An intentional radiator shall be designed to ensure that no antenna other than that furnished by the responsible party shall be used with the device. The use of a permanently attached antenna or of an antenna that uses a unique coupling to the intentional radiator shall be considered sufficient to comply with the provisions of this section. The manufacturer may design the unit so that a broken antenna can be replaced by the user, but the use of a standard antenna jack or electrical connector is prohibited. This requirement does not apply to carrier current devices or to devices operated under the provisions of §15.211, §15.213, §15.217, §15.219, or §15.221. Further, this requirement does not apply to intentional radiators that must be professionally installed, such as perimeter protection systems and some field disturbance sensors, or to other intentional radiators which, in accordance with §15.31(d), must be measured at the installation site. However, the installer shall be responsible for ensuring that the proper antenna is employed so that the limits in this part are not exceeded. Conclusion: PASS; EUT has internal PCB antenna. T251-0603/19 Page: 5 (49) 1.3 ANSI C63.4 Subpart selection Subpart C: Intentional Radiators 1.4 Class statement requirements • The Class B statement offers several suggestions for minimizing interference to radio or TV receivers, including reorienting the receiving antenna and moving the Class B device farther away from the receiver. 1.5 Occupied bandwidth measurement Fundamental frequency Minimum resolution bandwidth 9 kHz to 30 MHz 1 kHz 30 to 1000 MHz 10 kHz 1000 MHz to 40 GHz 100 kHz 1.6 Quasi-peak detector Frequency range Bandwidth (-6dB) 10 Hz to 20 kHz Full range (wideband) 10 kHz to 150 kHz 200 Hz 150 kHz to 30 MHz 9 kHz 30 MHz to 1 GHz 120 kHz 1.7 Peak, rms, and average detectors Frequency range Bandwidth (-6dB) 10 Hz to 20 kHz 10, 100, 1000 Hz 10 kHz to 150 kHz 1 and 10 kHz 150 kHz to 30 MHz 1 and 10 kHz 30 MHz to 1 GHz 10 and 100 kHz 1 GHz to 40 GHz 0.1, 1.0 and 10 MHz T251-0603/19 Page: 6 (49) 2 LIMITS 2.1 Subpart C: Intentional Radiators 2.1.1 Section 15.207, Conducted emission limits: Frequency Range (MHz) Limits (dBμV) Quasi-peak Average 0.15 to 0.5 66 – 56* 56 – 46* 0.5 to 5.0 56 46 5.0 to 30.0 60 50 * Decreases with the logarithm of the frequency. The shown limits in table shall not apply to carrier current systems operating as intentional radiators on frequencies below 30 MHz. In lieu thereof, these carrier current systems shall be subject to the following standards: • For carrier current systems containing their fundamental emission within the frequency band 535-1705 kHz and intended to be received using a standard AM broadcast receiver: no limit on conducted emissions. • For all other carrier current systems: 1000 μV within the frequency band 535-1705 kHz, as measured using a 50 μH/50 ohms LISN.…

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SIQ Ljubljana, Tržaška cesta 2, SI-1000 Ljubljana, Slovenia T +386 1 4778 100, F +386 1 4778 444, [email protected], www.siq.si Test setup photos Project file: C20191901 Date: 2019-07-22 Pages: 4 Product: plasma care device and charging station - Transceiver Type reference: plasma care Page: 2 (4) Figure 1: Radiated emission test from 9 kHz to 30 MHz Page: 3 (4) Figure 2: Radiated emission test from 30 MHz to 200 MHz Page: 4 (4) Figure 3: Radiated emission test from 200 MHz to 1 GHz