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Page 1: ...Instructions for Use plasma care plasma care spacer ...
Page 2: ... 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 ...
Page 3: ...25 9 1 2 Cleaning of the plasma source unit 26 9 1 3 Storage 28 9 2 Service 29 10 Orientation training and support 30 10 1 Orientation 30 10 2 Training 30 10 3 Service and support 30 10 4 Troubleshooting 30 11 Environmental conditions 31 11 1 Operating conditions 31 11 2 Storage conditions 31 11 3 Transport conditions 32 12 Service life 32 13 Disposal 33 14 Device Labeling 34 15 Technical specific...
Page 4: ... without previ ous notice For misprints and damages resulting thereof terraplasma medical GmbH is exempt from liability Other brand and product labels as well as product logos that are mentioned in this manual are brands of the respective licence holders and are hereby accredited terraplasma medical GmbH Parkring 32 85748 Garching b München Germany Tel 49 89 588 0 553 0 E Mail info terraplasma med...
Page 5: ...amage of the device serious injuries and may even result in life threatening situations 2 2 Symbols Refer to instruction for use Read the instruction for use Warning Please read the safety notes carefully Disregard thereof can result in injury to persons or damage to property Manufacturer s address Date of manufacture Serial number Lot number batch code Order number device reference of the manufac...
Page 6: ...he 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 Do not sterilize again Use by Sterilisation procedure ethylene oxide EO sterilisation Do not use when packaging is damaged Electrical device do not discard in domestic waste IP Level of protection against intrusion solid particles and ...
Page 7: ... on the cable as the cable might be damaged thereby ID004b Only use the original power supply delivered by the manufacturer The use of other power supplies is not admissible ID005 Do not use excessive force to attach a country specific adapter plug to the power supply The electrical contacts might be damaged thereby ID006 Only use the plasma care in environmental conditions as defined in chapter 1...
Page 8: ...h a temperature within the operating conditions see chapter 11 1 Operating conditions 2 3 2 Treatment and operation ID014 The treatment with the plasma care may only be performed by instructed healthcare professionals ID015 Only use the plasma care for its intended medical purpose see chapter 3 taking into account its indications and contraindications see chapter 3 ID016 Always use the plasma care...
Page 9: ...also leads to immedi ate interruption of the treatment If the treatment cannot be stopped by either of these two methods the energy supply of the plasma source can be interrupted by removing the plasma source unit ID023 The plasma care can cause electronic disturbances during its normal opera tion for its intended purpose which may interfere with the function of other elec tronic devices ID024 Oth...
Page 10: ...is generated at low concentra tions Treatments in the area of the head and particularly of the mouth should be avoided ID028b Upon treatment with the plasma care UV radiation is generated at very low intensity Avoid treatments around the eyes ID029 The application of antiseptics topical antibiotics etc should occur after the treatment with the plasma care Otherwise no statement regarding the effec...
Page 11: ... plasma care carefully and flush ID037 The plasma source unit needs to be cleaned as described at least once a month ID038 If the plasma source unit is used beyond its expected service life the plasma care will indicate this via a permanent red glow of the four segments of the plasma ring and the plasma source unit needs to be replaced 2 3 4 Medical device malfunction ID039 When the four segments ...
Page 12: ...ely ID042 When you notice that the environmental conditions change and that the plasma care is used outside of its operating requirements and specifications the treatment needs to be stopped 2 3 6 Performance characteristics The following performance characteristics might be limited if the device is operated in pres ence of electromagnetic disturbances The plasma source produces the required cold ...
Page 13: ...rd treatment methods Standard procedures using cleaning solutions debridement topically applied medications or antiseptics and wound dressings should be continued In general wound bed preparation using any form of debridement and wound irrigation or similar water based solutions should be performed prior to the plasma treatment However the plasma treatment should be carried out prior to the applic...
Page 14: ...avelling nurses The operators have undergone medical training and are experienced in the treatment of wounds in compliance with the current therapeutic guidelines Prior to use of the plasma care with the plasma care spacer all operators need to study the manual carefully and need to be instructed in the use of the plasma care The instruction can be given by the manufacturer or an expert Before usi...
Page 15: ...05 2020 Copyright terraplasma medical GmbH Page 15 38 5 Delivery contents The plasma care is delivered with the following components plasma care with removable plasma source unit docking station power supply for the docking station sterile individually packaged plasma care spacer single use only Instruction for Use ...
Page 16: ...plasma care flashes red yellow and green The removable plasma source unit contains the plasma source which is composed out of a high voltage electrode a dielectric barrier and a grounded electrode in the shape of a mesh at the front 6 2 plasma care user interface The user interface can be found on the upper side of the plasma care The interface allows the following commands by pressing the touch b...
Page 17: ...rked as invalid and cannot be used for any further treatments In case of an invalid spacer the plasma care device can not be activated With one spacer a maximum of 6 plasma treatments can be performed on a single patient The use of a spacer on more than one patient is not permitted due to the cross contamination risk 6 4 User interface The user interface indicates the system status and is used for...
Page 18: ...the On Off button briefly When the plasma treatment is started the individual plasma ring segments will flash one after the other and will each switch off after a quarter of the treatment time Plasma ring red Red flashes Indicates that the spacer was already used and is invalid A new spacer must be used Red glow Indicates a malfunction of the device Please proceed according to chapter 10 4 Trouble...
Page 19: ...ing station on off glow The blue control LED will glow as long as the docking station is plugged in 7 Starting the plasma care Prior to its first use the plasma care needs to be fully charged For this purpose carry out the following steps 1 Attach the power supply of the docking station to the docking station of the plasma care The connector for the power supply is inside the black indentation at ...
Page 20: ...charged This can take up to 3 hours ID004 Do not use excessive force or remove the plug by pulling on the cable as the cable might be damaged thereby ID005 Do not use excessive force to attach a country specific adapter plug to the power supply The electrical contacts might be damaged thereby ID007 Wait until the plasma care has adjusted to the permissible environmental tem perature especially if ...
Page 21: ...hing the medical device on and off 2 By exerting pressure for about 2 seconds on the on off button the plasma care is switched on and the symbol in the middle of the user interface glows white In the upper right corner the battery charge condition is indicated via the bat tery symbol Green means that the device is fully charged yellow indicates a semi charged level and red indicates a critically l...
Page 22: ...ond treatment of one minute can be performed on the same area or on an adjacent area Note If the plasma treatment is to be extended the used spacer must remain attached to the medical device After a few seconds the blue plasma ring re appears To continue the treatment press the on off button briefly to restart plasma generation Three sequential one minute treatments may be given to a wound area at...
Page 23: ... button Removal of the plasma care spacer also leads to im mediate interruption of the treatment If the treatment cannot be stopped by either of these two options the energy supply of the plasma source can be interrupted by removal of the plasma source ID028 Upon treatment with the plasma care ozone is generated at low concentra tions Treatments in the area of the head and particularly of the mout...
Page 24: ...or has not already been opened prior to usage of the spacer 8 3 Treating wounds with the plasma care In general the treatment of wounds with the plasma care is performed within the scope of the current therapeutic standards for wound treatment The use of the plasma care is in ad dition to the current recommendations for wound treatment 8 3 1 Adjunctive use of the plasma care for decontamination ID...
Page 25: ...fter the treatment with the plasma care Antiseptics e g iodopovidone solution polyhexanide octenidine Topicalley applied antibiotics e g fusidic acid sulfonamide gentamycin All other substances and reagents that remain in the wound after application ID029 The application of antiseptics topical antibiotics etc should occur after the treatment with the plasma care Otherwise no statement regarding th...
Page 26: ...of the device Allow the disinfection agent to take effect according to the manufacturer s instructions but at least 5 minutes Generally disinfection wipes are recommended Validated disinfection wipes are Bacillol AF Tissues BODE Chemie GmbH Pursept A Xpress wipes Schülke Mayr GmbH ID032 Avoid excessive cleaning fluids for example by frequent use of spray disin fectant because the electronic compon...
Page 27: ...h of the plasma source Avoid strong rubbing of the mesh 4 Allow the disinfectant to take effect according to the manufacturer s instructions 5 Allow the plasma source unit to dry over night Reattach the plasma source unit to the device 1 Hold the plasma care at the handle with one hand again 2 Grab the cleaned plasma source unit with the other hand at the edges on the side of the mesh 3 Position t...
Page 28: ... a new clean plasma source unit ID035a Examine the device both front and back for residuals of body fluids especially after the treatment of strongly exuding wounds ID036 When changing the plasma source unit check the wired contacts between the plasma care and the plasma source unit for corrosion Also check whether the plasma source unit has been placed onto the plasma care carefully and flush ID0...
Page 29: ... via support terraplasma medi cal 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 Please use the original packaging for returning the plasma care ID038 If the plasma source unit is used beyond its expected service life the plasma care w...
Page 30: ... of terraplasma medical GmbH can be contacted during the regular office hours Monday to Thursday from 09 00h to 17 00h Friday from 09 00h to 15 00h via Telephone 49 89 588 0 553 0 Fax 49 89 588 0 553 99 E Mail support terraplasma medical com 10 4 Troubleshooting Error Plasma ring glows red permanently Remove the spacer and re attach it again Check whether the plasma source unit is attached properl...
Page 31: ...erating conditions are met 11 1 Operating conditions The plasma care can be operated under regular lighting conditions at the work place The plasma care can be used for inpatient as well as outpatient care The plasma care and the spacer can be used at temperatures between 10 C and 35 C The plasma care and the spacer can be used at a relative humidity between 25 and 70 RH The plasma care and the sp...
Page 32: ...transported inside its packaging at a relative humid ity between 15 and 90 RH The plasma care spacer can be transported inside its packaging at temper atures between 20 C and 55 C The plasma care spacer can be transported inside its packaging at a relative humidity between 20 and 75 RH The plasma care and the plasma care spacer can be transported inside their packaging at atmospheric pressure betw...
Page 33: ... 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 The effective country specific disposal regulations and laws must be complied The plasma care needs to be discarded via a separate collection of electric and electronic appliances The e...
Page 34: ...lasma care Medical device class II Software Version 2 0 Plasma generation SMD Operating time 3 minutes User interface LED Touchpanel Supply voltage range 100 V 240 V Supply frequency range 50 Hz 60 Hz Isolation from mains voltage Sicherheitsnetzteil XP Power VEP24US12 Battery FEY ELEKTRONIK GMBH PA IEC LNB76 R001 Outer dimensions 16cm x 5 5cm x 6cm L x W x D Weight 320g Applied part of type BF IP2...
Page 35: ...ill not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the e...
Page 36: ... kHz Power frequency magnetic fiel IEC 61000 4 8 30 A m 50 Hz or 60 Hz Electrical fast transient burst IEC 61000 4 4 2 kV 100 kHz repetition frequency Surge voltages Wire against wire IEC 61000 4 5 0 5 kV 1 kV Conducted Interference in duced by High Frequency Fields IEC 61000 4 6 3 V 0 15 MHz up to 80 MHz 6 V at ISM Frequencybands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz up to 80 MH...
Page 37: ... 2 0 3 28 870 930 1720 1700 to 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 2 4 25 UMTS Puls modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 to 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Puls modulation 217 Hz 2 0 3 28 5240 5100 to 5800 WLAN 802 11 a n Puls modulation 217 Hz 0 2 0 3 9 5500 5785 The following table shows the transmission and receiving frequencies of the plasma care Re...
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