ACKERMANN 16-2050 User manual
SHAVER SYSTEM
Ackermann
www.ackermannsurgical.com
• Arthroscopy Shaver System #16-2050
• Handpiece #16-2050-100
• Footswitch #16-2050-200
User Manual
Arthroscopy Shaver System
SHAVER SYSTEM
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CONTENTS
1. Precautions 3
2.1. Intended use of the device 4
2.2. Contents of standard package, optional accessories 4
2.3.Deviceclassication 4
5
3.1. Front panel description 5
3.2. Rear panel description 6
3.3. Handpiece description 7
3.4. Footswitch description 8
4.1. Device installation 9
4.2. Basic settings 10
4.3. Connection of Handpiece to Control Unit 10
4.4. Connection of wired Footswitch to Control Unit 11
4.5. Connection of wireless Footswitch to Control Unit 11
4.6. Starting the device 12
5.1. Control Unit 12
5.2. Footswitch 12
5.3. Handpiece 12
5.3.1. Handpiece with automatic receiving ring of the shaver blades 13
5.3.2. Handpiece with manual receiving ring of the shaver blades 13
6. Maintenance and care 13
6.1. General information 14
6.2. Cleaning and disinfection of Control Unit and Footswitch 14
6.3. Cleaning, disinfection and sterilization of Handpiece 14
6.3.1. General information 14
6.3.2. Pre-cleaning 14
6.3.3. Mechanical cleaning and disinfection 15
6.3.4. Manual cleaning and disinfection 16
6.3.5. Inspection/lubricants 16
6.3.6. Packaging 16
6.3.7. Sterilization 17
6.3.8. Storage 17
6.3.9. Material compatibility 17
6.4. Reusability 18
7.1. Replacing fuses 18
7.2. Periodic inspections of the device 18
7.3. Warranty and post-warranty service 19
7.4. Basic troubleshooting of the device 19
9.1. Symbols and their meanings 22
9.2. Disposal of used electronic products 23
11. Appendix 26
12. Contact details 27
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•Theoperatinginstructionshowshowtooperate,maintainandservicetheequipment,sothatitsworkinglifeisaslongas
possible. Proper service is essential for a long-term trouble-free operation of the device.
•Staffoperatingthedeviceshouldfamiliarisethemselveswiththecontentsofthismanualbeforeinstallationanduseof
the device, and those who have access to it.
•Thedevicecanonlybeoperatedbydoctorsorassistingstaffwithappropriatequalications.
•ThedeviceismadeupinIsafetyclass.
•Toavoidriskofelectricshockthedevicehastobeconnectedonlytoasupplyingnetworkwithprotective
earthing.
•Beforeconnecting the device tothepower outlet,make surethat the parametersof thepower gridare identicalto
thoseinthedevicespecications.Supplyvoltage,frequencyandpowerconsumptionarespeciedintheremainderof
the documentation and on the rear panel of the device.
•Donotexposethedevicetostronghumidityorrain.
•Neverusethedeviceintheenvironmentsofammableanestheticgases.
•Ifammablegases(includinganestheticgases)arereleasedinthevicinityofthedevice,thelattershouldbeimmediately
switched off and unplugged from the power socket.
•Toavoidoverheatingthedevice,ensurethatadequateventilationisprovidedbeforestartingthedevice.Itisrecommended
to maintain a min. 10cm clearance from the left, right and rear sides of the device.
•Undernocircumstancesopenthecoverofthedevicewhenitisconnectedtopower.Electricvoltageinsidetheunitcan
reach0.4kV.Electricshockmayresultinpermanentdisabilityordeath.
•NEVERplacethedevicenearhotsurfacesorareassubjecttovibrationorshock.
•Repairsofthedevice,otherthanthosespeciedinthisoperatinginstruction,canbeperformedonlybymanufacturer
or by an authorised service provider specied by the manufacturer. The only repair that the user can perform, after
familiarising themselves with the contents of the operating instruction: changing fuses for the electric power connection.
Service address can be found in the last page of the operating instruction.
•ChargingofthebatteryofwirelessFootswitchshouldbecarriedoutoutsidetheoperationaltheatre.
•UndernocircumstancesopenthehousingofFootswitch.
•BatteryofwirelessFootswitchmustn’tbereplacedbytheuser.
•Incaseofanydisturbancesormalfunctionsinthefunctioningofthedevice,immediatelyturnitoffusingthepower
switchlocatedontherearpanel.Takingintoaccounttheaboveguidance,themanufacturerfeelsresponsiblefor
thesafetyandreliabilityofthedevice.Themanufacturerdoesnotassumeresponsibilityfordamageswhichhavearisen
through abuse or incompatible with the intended operation of the device.
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ShaverSystem16-2050inallvariantshasbeenspecicallydesignedfordrivingofbladesandsurgicalcutters,whichare
used during treatments of orthopedic reconstruction by using an endoscopic method named arthroscopy.
Table1presentscomponentsofShaverSystem:
Table 1. Shaver System variants:
Pos. Shaver System
1# 16-2050 Control Unit incl. Handpiece with manual lock and standard
Footswitch
Thedevicecanbeusedonlyfortreatment,suchas:arthroscopy.
Itistheuser’sresponsibilitytousethedeviceproperlyasintended.Notcomplyingtotheoperatinginstructionmayresult
in danger for the patient or any of users.
Table 2. Standard package contains.
Pos. Article no. Qty.
1Shaver System 16-2050 1
2PowercordwithEUplug n/a 1
3Operating instruction n/a 1
4Spare fuses acc. to table 5 2
Thedeviceissuppliedinapackagethatshouldbekeptforpossiblefuturetransport.
The Shaver System Set has been classied as Class IIa in accordance with rule 9 of Directive MDD/93/42/EEC. Cited
standardsarespeciedinTable4.
Table 4. List of standards, to which the manufacturer referred to during conformity assessment.
No. Standard Description
1EN60601-1 MedicalelectricalequipmentPart1:Generalrequirementsforbasicsafetyand
essential performance1
2EN60601-1-2
MedicalelectricalequipmentPart1-2:Generalrequirementsforbasic
safetyandessentialperformance--CollateralstandardElectromagnetic
compatibilityRequirementsandtests
3ENISO14971 Medical devices. Application of risk management to medical devices
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4EN60601-1-6 MedicalelectricalequipmentPart1-6:Generalrequirementsforbasicsafety
and essential performance - Collateral standard: Usability
5ENISO62366 MedicaldevicesApplicationofusabilityengineeringtomedicaldevices
6ENISO62304 Medical device software - Software life cycle processes
7ENISO17664
SterilizationofmedicaldevicesInformationtobe
provided by the manufacturer for the processing of
resterilizable medical devices
8EN10993-1 BiologicalevaluationofmedicaldevicesPart1:
Evaluationandtestingwithinariskmanagementprocess
9EN10993-18 BiologicalevaluationofmedicaldevicesPart18:Chemicalcharacterizationof
materials
10 EN15223-1 MedicaldevicesSymbolstobeusedwithmedicaldevicelabels,labellingand
informationtobesuppliedPart1:Generalrequirements
11 EN980 Symbols for use in the labelling of medical devices
12 EN1041 Information supplied by the manufacturer of medical devices
1. Display window: displays operating parameters in digital form.
: socket for the Handpiece 1.
: socket for the Handpiece 2.
: socket for the Footswitch.
:switchesthedevicefroma“STANDBY”stateofenergysaving/sleeptoaworkingstateandvice
versa.
: function key to switch the shaver blade in the Handpiece to anti-clockwise rotation. If
buttons(6)and(7)arepressedatthesametime,thedevicewillbeworkingintheoscillationmode.
:functionkeytoswitchtheshaverbladeintheHandpiecetoclockwiserotation.Ifbuttons(6)
and(7)arepressedatthesametime,thedevicewillbeworkingintheoscillationmode.
: stepwise reduction of the speed to the lower level of rotational speed.
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:stepwiseincreaseofthespeedtothenexthigherlevelofrotationalspeed.
: function key which enables switching between two connected tools. It is available only if both tools are
presentinsockets“HANDPIECE1”and“HANDPIECE2”.
11. : illumination corresponds to the following states:
•the“Standby”LEDblinksatafrequencyof0.5Hz-thismeansthatthedeviceisina“Standby”state,
•the“Standby”LEDilluminatescontinuously-thedeviceisswitchedonandworkingproperly.
of the device
: used to remove warm air from inside of the Control Unit.
: contains information on the device type, wattage, power supply fuses, serial number and date of
manufacturing.
15. Power switch: single pole ON/OFF switch used to enable and disable power to the device.
16. :powercablesocketwithfusedrawer.Thenominalvaluesforfusesarespeciedonthedevice
labelTable5.Itisimperativetodisconnectthepowercordduringmaintenance,cleaningorreplacementoffuses.
17. Fuse drawer: where protecting the device power supply fuses are installed. Changing the fuses is described in the
point 7.1.
:connectorforequalisingtheelectricalpotentialofthehousingof
the Control Unit with the potential of other devices.
: mechanical element securing the device from unauthorised opening. Damage or removal of seal will
result in absolute loss of warranty and transfer of responsibility for the operation of the device to the user.
device to the user.
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: the shaver blades are securely engaged when the locking device has snapped shut
visiblyandclickingsoundcanbeheard.Theshaverbladecannotbereleased,notevenafterrepeatedpulling.
21. Valve control:toregulatetheextractionofsalinesolutionfromtheoperativesite.
23. Aspiration port: when the tube of the vacuum pump is mounted onto this nozzle, the saline solution is sucked off
through the Handpiece.
: for increased stability of the connection between the Handpiece and the cable.
: 3 meters long cable for comfortable attachment to the Control Unit.
: connection to attach the Handpiece to the Control Unit. An integrated lock at the plug protects the cable of the
Handpiece from being pulled out by accident.
: protects the plug during cleaning, disinfection and sterilization process.
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:pedalbuttontoswitchtheshaverbladeintheHandpiecetoanti-clockwiserotation.Thenumberofrotations
dependsonthesetspeedwhichcanbeadjustedviatheUnitControlbuttons(8)and(9)orFootswitchbutton(34).
:pedalbuttontoswitchtooscillatingmode.Thenumberofrotationsdependsonthesetspeedwhich
canbeadjustedviatheControlUnitbuttons(8)and(9)orFootswitchbutton(34).Theoscillationfrequencydependson
settings.
32. FWD:pedalbuttontoswitchtheshaverbladeintheHandpiecetoclockwiserotation.Thenumberofrotationsdepends
onthesetspeedwhichcanbeadjustedviatheControlUnitbuttons(8)and(9)orFootswitchbutton(34).
33. TOOL: pedal button to initiate the change function of the steerable device “HANDPIECE 1” (2), “HANDPIECE 2” (3)
connected to the Control Unit.
:pedalbuttontoregulatethespeedoftheshaverbladeintheHandpieceduringuse.Eachtimethebuttonis
pressed,thespeedisincreasedtothenexthigherlevel.
35. Handle: used for lifting and carrying of the Footswitch.
: connection between the Footswitch and the Control Unit, serves to transmit the selected functions of the
individualFootswitchbuttons(30-34).
37. Protective cap: for increased stability of the connection and protection against fracture.
: connection to attach the Footswitch to the Control Unit. An integrated lock at the plug protects the cable of the
Footswitch from being pulled out by accident.
: as a part of the Footswitch serves to transmit information from the Footswitch to the Control Unit, with
which is connected electrically.
: necessary for communication between the Footswitch console and the receiver attached to the Control
Unit.
:usedtoconnectthecharger(45).Chargingshouldbedone outside ofthetreatmentroom. While
charging, functions of the Footswitch are disabled.
:ashingonbluediodesignalsthepropercommunicationbetweentheFootswitchconsoleandthe
receiver(39).
: lighting on green, shows the accumulator level.
: lighting on red diode signals the incorrect charger connection or not compatible charger connection.
: dedicated to charge the accumulator of the Footswitch. Should be used only outside the operating
room.
Thischapterdescribesthecorrectinstallationandstart-upofthedevice.Therststepisthecorrectinstallationofthe
ControlUnit.Thelanguageselectfeatureallowstheoperatortoselectthelanguageofhischoice.Ifthesubsequentsteps
described in chapters 4.1. to 4.6. have been followed correctly, the device is now ready for use and the shaver blades can
be attached.
When the Shaver System Set is not in active use, protect the device against inadvertent actuation of the
Footswitch and the Handpiece!
Beforeinstallation,makesurethatthedevicehassucientventilationbymaintainingaminimumdistanceof10cmfrom
the right, left and rear sides of the device.
Device installation:
•theonlyintendedpositionoftheControlUnitishorizontal,inwhichthedeviceisplacedonaatsurfaceonitsfourrubber
feet(12).Inaddition,adequateventilationaroundtheControlUnitmustbeprovided,
•theplaceofinstallationshouldbeaat,dryandcleansurface.Thiscanbeatable,shelfofanendoscopytrolleyorother
elements meant for installation of medical devices.
Connecting the device to power:
•connect,usinganappropriatelead,theequipotentialboltlocatedontherearoftheControlUnittoanequipotentialstrip.
Thecableinsulationshouldbeyellow-green,
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•connectthepowercordprovidedwiththedevicetothesocket(16)onthebackoftheControlUnit,
•plugthepowercordintothepowersocket.Thevoltageshouldbewithintherangeindicatedonthedevicelabel.
Turnonthedevice:
•Aproperlyinstalledandconnecteddeviceshouldbestartedusingthe“ON/OFF”switch(15)locatedontherearpanel.
The“STANDBY”button(5)willstartashingatafrequencyof0,5Hz,indicatingthatthedevicehasswitchedtostandby
mode.
•Oncethedeviceisinstandbymode(seechapter4.1.),presssimultaneouslyandholddownthe“SPEEDDOWN”(8)and
“SPEEDUP”(9)buttonswithyourrighthand.
•Stillholdingbuttons(8)and(9)brieypressthe“STANDBY”button(5)withyourlefthand.
•Onceyouareintherequiredmenu,youcanreleasethesebuttons.Youcannowselectthelanguageyourequire.Thelast
selected language is shown.
To change the language, press buttons “SPEED DOWN” (8) or “SPEED UP” (9). The user can choose between German,
English,French,Russian,PolishandTurkish.Theselectedlanguagemustbeconrmedbypressingthebutton“TOOL”(10).
•Oncetheselectedlanguagehasbeenconrmed,thenextsettingscanbeselected:oscillationtimeandbrightnessofthe
VDFdisplay.Again,thesettingsareselectedbypressingthebuttons“SPEEDDOWN”(8)or“SPEEDUP”(9).Conrmsettings
withthebutton“TOOL”(10).Thecontrolunitmemorizesthesettingsandautomaticallyreturnstonormaloperatingmode.
•Theplug(26)attheendofthecableoftheHandpiecehastobeconnectedtooneofthesockets“HANDPIECE1”(2)or
“HANDPIECE2”(3)atthefrontpaneloftheControlUnit.UptotwoHandpiecescanbeconnectedtotheControlUnitatthe
same time.
•Theplug(26)oftheHandpieceismarkedwithanotchandareddot.Whenconnectingtheplug,makesurethatthered
dotontheplugisinthesamepositionasthereddotonsockets(2)or(3)oftheControlUnit.Thepinsinsidetheplug(26)
might otherwise get damaged.
•WhentheControlUnitisactivated(seechapter4.6.),theHandpieceisreadyforuse.TheHandpiececanbeoperatedvia
the Control Unit and/or the Footswitch.
TheControlUnitisprovidedwithaso-calledprioritycircuitfortheHandpiecethatwasconnectedrstirrespectiveof
whethersocket“HANDPIECE1”(2)or“HANDPIECE2”(3)waschosen.WhentwoHandpiecesareconnectedatthesame
time,activatetherequiredHandpiecebypressingthebuttonTOOL(10).
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ThemaximumspeedforShaverSystemis8000rpm.
Handpiecesmusthavecometoastandstillbeforetheycanberemovedfromthesocket(2)and/or(3)ofthe
ControlUnit.HoldHandpiecesonlybytheircase(22)duringuse.
•Theplug(38)attheendoftheFootswitchcablehastobeconnectedtothe“FOOTSWITCH”(4)socketatthefrontpanelof
the Control Unit. Only one Footswitch can be connected.
•Theplug(38)oftheFootswitchismarkedwithanotchandareddot.Whenconnectingtheplug,makesurethatthered
dotontheplugisinthesamepositionasthereddotonthesocket(4)oftheControlUnit.Thepinsinsidetheplugmight
otherwise get damaged during connection.
•Toavoiddamage,makesuretopullattheplug(38)itselfandnotthecablewhenremovingtheplug.WhentheControlUnit
isactivated(seechapter4.6.),theHandpiececanbeoperatedviatheFootswitch.
• The plug (38) has to be connected to the “FOOTSWITCH” (4) socket at the front panel of the Control Unit. Only one
Footswitchcanbeconnected.Beforeconnectingtheplug(38)tothe“FOOTSWITCH”(4)socketpleasemakesurethatthe
three-number-codes on the receiver and the Footswitch console are the same, otherwise the Footswitch will not work.
•Theplug(38)oftheFootswitchismarkedwithanotchandareddot.Whenconnectingtheplug,makesurethatthered
dotontheplugisinthesamepositionasthereddotonthesocket(4)oftheControlUnit.Thepinsinsidetheplugmight
otherwise get damaged during connection.
•WhentheControlUnitisactivated(seechapter4.6.),theHandpiececanbeoperatedviatheFootswitch.
Please adhere to the following steps to initialize the Footswitch work:
•TurntheFootswitchonbypressinganybutton.TheconnectionbetweenthewirelessFootswitchconsoleandthereceiver
(39)willbeestablishedautomatically,whichmaytake 5sec. andin extremecases upto 20sec. (timeof receiver (39)
vericationincreasese.g.becauseofmanyBluetoothdevicesaround).Properdatatransmissionissignaledbyashing,
ConnectionLED(42).
•Beforestartingthework,makesurethattheaccumulatorisappropriatelycharged.IfthewirelessFootswitchconsole
isnotconnectedwiththereceiver(39),theaccumulatorlevelisdisplayedtilltheconnectionwiththereceiver(39)willbe
established or till the Footswitch console will be switched to stand-by mode. If the Footswitch console is connected with
thereceiver(39),tochecktheaccumulatorlevelpleasepress“TOOL”(33)buttonforabout3seconds,thecurrentlevelis
displayedonthethree,greendiodes(43).Diodesareturnedafter10sec.off.
•ThecommunicationrangebetweentheFootswitchconsoleandthereceiver(39)isfrom0to3m.Itisrecommended
toplacenoobstructionsonthelineFootswitchconsole–thereceiver(39),suchas:metalelementsconnectedtoGND
potential,thick-walledmaterialsabsorbingradiowavesfrequency2,4GHz,thatcanreducetransmittedsignalpower.
•Afterbreakingthecommunication(forexampleinthecaseoftoolargedistancefromthereceiver(39)),establishingthe
newconnectioncantake7sec.,inextremecasesupto20sec.
•TheFootswitchisautomaticallyswitchedtostand-bymode,afterturningofftheControlUnitwithMainsswitchPOWER
ON/OFF(15),tosavetheaccumulatorenergy.Thecommunicationisstopped.Inbothcases,toactivatetheFootswitch
(afterturningofforlongernotusingtheFootswitch)pressanybuttonontheFootswitchconsole.Thecommunicationwill
be established again.
•Tochargetheaccumulatorpleaseconnectthebatterycharger(45)tothesocket(41)ontheFootswitchconsole.While
charging,connectionbetweentheFootswitchconsoleandthereceiver(39)isstopped.(theFootswitchisinactive).
•Theaveragechargingtimeis4handisdependentonthedischarginglevel.
•IftheredErrorDiode(44)isturnedoncontinuouslythenanincorrectconnectionofthechargerissignalizedorawrong
type of charger was used.
•IftheErrorDiode(44)ispulsatingthetransmissionerrorsrelatedtodisconnectionofthereceiver(39)intheConsoleare
signalized.
not a medical purpose device.
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•Oncethedeviceisinstandbymode(seechapter4.1.),pressthe“STANDBY”button(5).Themaindisplay(1)willdisplaythe
logoandthemodelofdeviceandallbuttonsoftheinterfaceorthe“STANDBY”LEDwillbelitcontinuously.
Deviceisreadytowork.“Ready”mode.
unauthorized personnel.
•Ventilation: always ensure good ventilation at the rear panel of the Control Unit to prevent
• Unintentional opening of the Control Unit is prevented by an anti-tamper seal.
•Power supply:deviceworksatavoltagerangeof100to240Volts(50or60Hz).Priortoinitialstart-up,makesurethatall
necessaryfusesarepresentinthefusebox.Thedeviceissuppliedwithsparefuses.Thesemustbeinstalledasexplained
inchapter7.1.Thepowercableshouldbeconnectedtothepowercablebox(16)attherearpanelofthedeviceandtothe
socket.
•switchthedeviceonbyturningthe“POWERON/OFF”switch(15)ontherearpaneloftheControlUnitinto
“ON”position.Pressthe“STANDBY”button(5)uponwhichthedisplaywillswitchitselfonandperformabriefself-test,
after which the last used settings are reloaded.
the keyboard on the front panel can be used to control all connected Handpieces and to access the language
andoscillationmodeselectmenu.Theadditional“STANDBY”(5)buttononthefrontpanelallowsthedevicetobeswitched
offintostand-bymode-withoutentirelycuttingoffthepowersupply.Blinking“STANDBY”buttonorLEDlitcontinuously
(5)whilebuttons(6)to(10)aredimmedindicatesthatthedeviceisinstand-bymode.Ifyouwishtoturnoffthedevice
completely,turnthemain“POWERON/OFF”(15)switchontherearpanelinto“OFF”position.
ThesettingsfortheactiveHandpiece,i.e.speed,rotationand/oroscillation,canbecontrolledviatheFootswitch.The
Footswitchisprovidedwith3buttons(30-32)(seechapter3.4.)toselectthedirectioninwhichtheshaverbladeistomove
intheHandpiece.Thespeedcanbeincreasedanddecreasedinintervalsviathebuttons(8)and(9)ontheControlUnitor
viathebutton(34)ontheFootswitch.
All functions of the shaver blades in the Handpieces can be controlled via the Footswitch or the Control Unit, i.e. direction
ofrotation,oscillationandspeed.Withtheadaptorillustratedbelow,allshaverblades:Linvatectypearesuitedforthe
Handpieces that come with the Control Unit.
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Please adhere to the following steps when locking the shaver blades into the Handpiece:
•InserttheshaverbladeintotheopeningoftheHandpieceuntilyoucanfeelresistance.Theshaverbladeisproperly
engaged when you can hear a clearly audible sound and the instrument cannot be removed, even by pulling.
•Toremovetheshaverblade,turnthereceivingring(20)oftheHandpieceinanti-clockwisedirection,whichautomatically
releases the shaver blade. Remove the shaver blade above the operating table only. Hold the Handpiece in upright position
toavoiduncontrolledejection.
•Werecommendtoworkatanappropriatespeed,dependingonthetypeofusedshaverblade.Forinformationonthe
respectivemaximumspeeds,pleaserefertotheinstructionsforuseprovidedwiththeshaverblades.
•Thetubeofthevacuumpumpintheoperatingtheatreisconnectedtotheaspirationport(23)toensureproperdrainage
of the saline solution containing tissue residues.
•TheHandpiececanbeusedbybothleftandrighthandedoperators.Itisessentialtomakesurethatthevalvecontrol(21)
ontheHandpiecefacesupwardsatalltimessothatitisalwaysreadyforuse.Whenthevalvecontrol(21)isswitchedtoits
frontposition(towardsthereceivingring(20),thedrainageofthecontaminatedsalinesolutionisreducedtoaminimum.
Maximumdrainagetakesplacewhenthevalvecontrol(21)isswitchedtotherear(i.e.towardsthecable(25)).Between
thesetwopositions,thevalveisinnitelyvariable.
Please adhere to the following steps when locking the shaver blades into the Handpiece:
•Thereceivingring(20)oftheHandpieceshouldbeopened(ovalcuttingsofthelockofreceivingring(20)shouldbein
verticalposition).Inserttheshaverbladeinsuchawaythatpins,onitssides,comeintothecuttingsofthesocket.Push
untilyoucanfeelresistance.Next,thelockofreceivingring(20)shouldbeturnedtherangeof90°.Theshaverbladeis
properly engaged when you can hear a clearly audible sound and the instrument cannot be removed, even by pulling.
•Theseactivitiesshouldberepeatedinadverseordertoremovetheshaverbladefromthesocket.Removetheshaver
bladeabovetheoperatingtableonly.HoldtheHandpieceinuprightpositiontoavoiduncontrolledejection.
•Werecommendtoworkatanappropriatespeed,dependingonthetypeofusedshaverblade.Forinformationonthe
respectivemaximumspeeds,pleaserefertotheinstructionsforuseprovidedwiththeshaverblades.
•Thetubeofthevacuumpumpintheoperatingtheatreisconnectedtotheaspirationport(23)toensureproperdrainage
of the saline solution containing tissue residues.
•TheHandpiececanbeusedbybothleftandrighthandedoperators.Itisessentialtomakesurethatthevalvecontrol(21)
ontheHandpiecefacesupwardsatalltimessothatitisalwaysreadyforuse.Whenthevalvecontrol(21)isswitchedtoits
frontposition(towardsthereceivingring(20),thedrainageofthecontaminatedsalinesolutionisreducedtoaminimum.
Maximumdrainagetakesplacewhenthevalvecontrol(21)isswitchedtotherear(i.e.towardsthecable(25)).Between
thesetwopositions,thevalveisinnitelyvariable.
TheHandpiecemustbecleaned,disinfectedandsterilizedpriortoeveryuse.TheControlUnitandtheFootswitchmust
alsobecleanedanddisinfected,buttheydonotrequiresterilization.Thisalsoappliestotheveryrstuseafterdelivery,
because all components of the Control Unit are supplied in non-sterile condition and without having been disinfected.
Thoroughcleaninganddisinfectionareessentialpreconditionsforaneffectivesterilization.
Thedivision/entityinchargeofreprocessinghastomakesurethat:
•validatedcleaning,disinfectingandsterilizationmethodsareused,
•thewasher/disinfectorandthesterilizerarecheckedandservicedinregularintervals,
•thevalidatedparametersarefollowedduringeveryreprocessingprocedure.
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In addition to the above, the country specic legal provisions regarding reprocessing of medical devices have to be
observed!
Always wear protective clothing during the reprocessing of contaminated medical instruments, i.e. eye and mouth
protectors, chemical-resistant gloves and moisture repellent clothes. Blood, residual tissues and other infectious
materials pose an increased risk of infection.
Alwaysmakesuretoremovethepowercablefromtheplugandthepowercablesocket(15)ontherearpaneloftheControl
Unit prior to cleaning. During the cleaning process, the device must not be connected to the power supply in any way.
TheControlUnitandtheFootswitchmustbecleanedanddisinfectedaftereveryuse.Toremovedustandotherdirtor
contaminationuseacleanclothmoistenedwithcleaninganddisinfectantsolution.Makesurethattheclothisjustmoist
andnotsoakingwettopreventmoisturefromenteringthesockets(2),(3)and(4)oftheControlUnit.
When choosing the cleaning and disinfection solution, make sure:
•touseaproductthatissuitableforwetwipedisinfectionofmetalandplasticcomponents,
•tochooseaproductwithprovensuitability(e.g.approvedbytheGermanAssociationforHygieneandMicrobiology(DGHM)
ortheAssociationforAppliedHygiene(VAH),authorizedbytheFDAorprovidedwithaCEmark),forexampleMicrobac
forte,VeloxAForother.
•thatthedetergentiscompatiblewiththedisinfectant,
•thatbothagentsarecompatiblewiththeControlUnitanditsaccessories(seechapter6.3.9.materialcompatibility).
Theconcentrationand immersion time indicatedby the manufacturer ofthedetergentsanddisinfectants havetobe
strictly observed.
Give preference to mechanical cleaning and disinfection of the Handpiece in the washer /disinfector. Manual reprocessing
(includingultrasonicbath)shouldonlybechosenifmechanicalreprocessingisnotanoption.
Manual cleaning and disinfection may only take place if the division/entity in charge is in possession of an ocially
approveddeviceandproductspecicprocessvalidationandtheyarepreparedtoassumeresponsibilityfortheprocess.
In both cases, pre-cleaning is absolutely essential!
Reusable instruments, such as shaver blades, must be reprocessed as indicated in the instruction pamphlet enclosed
with the instruments or according to the information provided by the manufacturer.
AnyvisiblecontaminationmustberemovedfromtheHandpieceimmediately(withintwohoursattheverylatest).
Procedure:
1.WhenremovingtheHandpiecefromtheControlUnit,makesuretopullitoutbyholdingtheplug(26)andnotbypulling
thecable.Sealplugwithprotectivecap(27).
2. Use a soft brush or a soft clean cloth with tap water or a disinfectant solution to remove any contamination from the
Handpiece.Ifusingadisinfectantsolution,makesurethatthisisfreeofaldehyde(riskofproteinxation)andsuitablefor
disinfectingthematerialsinvolved(seechapter6.3.9materialcompatibility).Chooseaproductwithprovensuitability(e.g.
approvedbytheGermanAssociationforHygieneandMicrobiology(DGHM)ortheAssociationforAppliedHygiene(VAH),
authorizedbytheFDAorprovidedwithaCEmark).
3.Forpre-cleaningtheinnerluminachooseabrushwithmatchingdiameter.Thisappliestothesuctionchannelandthe
receivingring(20).Movevalvecontrol(21)backandforthrepeatedlyduringcleaning.
Next,placetheHandpieceintoanultrasonicbathlledwithcleaningsolution.PlacetheHandpieceinuprightposition,
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withthereceiving ring (20)facing downwards.The Handpiece and the cable must be completely covered by cleaning
solution.Thevalvecontrol(21)mustbesetinMAXposition,whenchoosingthecleaningsolution,makesurethat:
•thesolutionissuitableforcleaninginstrumentswithmetalandplasticcomponents,
•allchemicalscontainedinthesolutionarecompatiblewiththemedicaldevices(seechapter6.3.9material
compatibility),
•thesolutionissuitableforultrasonicbaths(i.e.nofoaming).
5. Rinse the entire Handpiece. Rinse all lumina, e.g. the suction channel and the closing mechanism of the receiving ring
withawaterpistolwithcoldwaterforatleast10seconds(staticwaterpressure:3.8bar).Makesurethatthevalvecontrol
(21)isinMAXpositiontopreventanycontaminationfromremaininginthereceivingringorinthesuctionchannel.
Pleasenotethattheabovepre-cleaningprocessandthecleaningagentsused(seepoint2and3)merelyservetoprotect
the person carryingout the reprocessingprocedure.Thisdoes not inanyway replace the disinfectioncycle whichis
absolutely essential.
Formanualremovalofcontamination(seepoint2and3),onlyusesoftbrushesandsoftcleanclothesthatareintended
forthispurpose.Theuseofmetalbrushesandsteelwoolisnotpermittedasthesewoulddamagethesurface.Takegreat
carewhencleaningtheHandpiece,especiallywhencleaningtheluminainthereceivingringandthesuctionchannel(see
point3and5).Inabsenceofanultrasonicbath(seepoint4),anordinarybathisacceptableinexceptionalcases,inwhich
case a minimum immersion time of 20 minutes must be observed.
The suitability of these medical devices for effective pre-cleaning was tested and proved by an independent test laboratory.
The detergent Neodisher Mediclean forte (0.5 %) (Dr. Wiegert GmbH & Co. KG, Hamburg) was used. The above work ow was
determined by the tests in the test laboratory.
When choosing the washer / disinfector, make sure that:
•thesuitabilityofthewasher/disinfectorhasbeenproven(e.g.authorizedbytheFDAorprovidedwithaCEmarkpursuant
toDINENISO15883),
•aprogramforthermaldisinfectionisavailable(Aovalue>3000or-inolderdevices-aminimumholdtimeof5minutesat
90°C).AchemicaldisinfectioninvolvestheriskofresiduesbeingleftontheHandpiece,
•theprogramissuitableforthesemedicaldevicesandthatitcomprisesasucientnumberofrinsingcycles,
•thenalrinseisdonewithsterilewater,almoststerilewaterorwaterwithalowcontentofEndotoxin(max.numberof
Endotoxinunits:0,25/ml)(e.g.processedwater),
•theairusedfordryingisltered,
•thewasher/disinfectorisservicedandcheckedinregularintervals.
When choosing the detergent, make sure that:
•itissuitableforcleaningmedicaldeviceswithmetalandplasticcomponents,
• if thermal disinfection is not an option, a suitable disinfectant with proven suitability (e.g. approved by the German
AssociationforHygieneandMicrobiology(DGHM)ortheAssociationforAppliedHygiene(VAH),authorizedbytheFDAor
providedwithaCEmark)mustbeused.Thedisinfectantmustbecompatiblewiththedetergent,
•allchemicalsusedduringtheprocessmustbecompatiblewiththepresentmedicaldevices(seechapter6.3.9material
compatibility).
Theconcentrationsspeciedbythemanufacturersofthedetergentsanddisinfectantshavetobestrictlyobserved.
Workow:
1.LooselycoilupthecableoftheHandpiecewithadiameterof30cm.
2. Immerse the Handpiece in the washer /disinfector. Make sure that the Handpiece does not touch any other instruments
andthatthereceivingring(20)isfacingdownwards.Itcanbeplacedinverticalordiagonalposition.
3.Theaspirationport(23)ofthesuctionchannelmustbeconnectedtoaexibletubeatthebasket.Makesurethatthe
valvecontrol(21)isinMAXposition.
Start the program.
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5. Once the entire cycle is completed, remove the Handpiece from the washer /disinfector.
6. Check the Handpiece to make sure that it is ready for use. Wrap immediately after removal from the washer /disinfector
(seechapter6.3.5Inspection/lubricantsand6.3.6Packaging).IftheHandpieceisstillwet,dryatacleanplace.
The suitability of these medical devices for effective mechanical cleaning and disinfection was tested and proved by an
independent test laboratory. A washer /disinfector G7735 CD (Co. Miele & Cie. KG, Gutersloh, Germany) and the detergent
Neodisher Mediclean forte (0.5 %)(Dr. Wiegert GmbH &Co. KG, Hamburg) were used. The above work ow was determined by
the tests in the test laboratory.
Manualreprocessing(includingultrasonicbath)shouldonlybechosenifmechanicalreprocessingisnotanoption.Manual
cleaninganddisinfection may onlytakeplaceif thedivision/entityinchargeisin possessionof anociallyapproved
deviceandproductspecicprocessvalidationandiftheyarepreparedtoassumeresponsibilityfortheprocess.
When choosing the detergent, make sure that:
•itissuitableforcleaningmedicaldeviceswithmetalandplasticcomponents,
•itssuitabilityhasbeenproved(e.g.approvedbytheGermanAssociationfor HygieneandMicrobiology(DGHM)orthe
AssociationforAppliedHygiene(VAH),authorizedbytheFDAorprovidedwithaCEmark),
•allchemicalsusedarecompatiblewiththepresentmedicaldevice(seechapter6.3.9materialcompatibility).
Werecommend a combined solution for cleaning and disinfection, for example Korsolex plus(Co. BodeChemie).The
concentrationandimmersiontimespeciedbythemanufacturersofthedetergentsanddisinfectantshavetobestrictly
observed.Usesterilewater,almoststerilewaterorwaterwithalowcontentofEndotoxin(max.numberofEndo-toxin
units:0.25/ml)(e.g.processedwater)only.Theairusedfordryingmustbeltered.
Workow:
1.ImmersetheHandpieceinabathlledwithcleaning/disinfectantsolution.MakesurethattheHandpieceisinupright
position,withthereceivingring(20)facingdownwards.TheHandpieceandthecablemustbecompletelycoveredwith
cleaningsolution.Thevalvecontrol(21)mustbeinMAXposition.
2. During the immersion time, clean the lumina of the receiving ring and the suction channel several times with a brush of
matchingdiameter,whilstmovingthevalvecontrol(21)backandforth.
3.LifttheHandpieceoutofthebathandrinsewithsterileoralmoststerilewaterforatleast10minutes.Makesurethat
thereceivingring(20)andthesuctionchannelarecompletelyfreeofresiduesoftissueandchemicals.
DrytheHandpiecewithlteredcompressedair.Ensurethatthereceivingringandthesuctioncanalarefreeofany
residual moisture.
5.ChecktheHandpiecetomakesurethatitisreadyforuseandwrapimmediately(seechapter6.3.5Inspection/lubricants
and6.3.6Packaging).IftheHandpieceisstillwet,dryatacleanplace.
Aftercleaninganddisinfection,removetheprotectivecap(27)fromtheplug(26)andchecktheHandpieceforcorrosion,
damagedsurfaces,spallingandvisualcontamination.DiscarddamagedHandpieces(seechapter6.4Reusability).Incase
of residual contamination, repeat the complete cleaning and disinfecting process.
TheinsideoftheHandpiecemustnotbemoistenedwithanytypeoflubricant!
Placetheprotectivecap(27)backontotheplug(22).Thevalvecontrol(21)mustbeopen(MAXposition)whentheHandpiece
issterilized,whichiswhyyouhavetoensureduringwrappingthatthevalvecontrolisincorrectposition.Looselycoilup
thecableoftheHandpiecewithadiameterof30cm.WraptheHandpieceindisposablesterilizationpouches(singleor
double)and/orinasterilizationcontainer,accordingtothefollowingconditions:
•ENISO11607/ANSIAAMIISO11607,
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•suitableforsteamsterilization(heatresistantupto141°C,sucientpermeability),
•theHandpieceisadequatelyprotectedfrommechanicaldamage,
•sterilizationcontainersmustbeservicedinregularintervalsaccordingtotheinstructionsofthemanufacturer.
Use the below described method of sterilization only. All other methods are prohibited.
Steam sterilization:
•fractionatedvacuumandgravitationmethod(withsucientdryingtime(atleast10minutes)).Thegravitationmethodis
less effective and should only be used if no fractionated vacuum is available,
•steamsterilizeraccordingtoDINEN13060/DINEN285,
•validatedaccordingtoISO17665(previouslyDINEN554/ANSIAAMIISO11134)(Start-upandproductspecicperformance
assessment),
• the temperature during sterilization must not exceed 138°C (280°F plus tolerance) according to DIN EN ISO 17665
(previouslyDINEN554/ANSIAAMIISO11134),
•sterilizationtime(holdtimeofthesterilizationtemperature):
•fractionatedvacuum:atleast3minutesat132°C(270°F)/134°C(273°F),
•gravitationmethod:atleast20minutesat121°C(250°F).
The suitability of these medical devices for effective sterilization was tested and proved by an independent test laboratory.
A sterilizer Selectomat HP 666-1 HRED (co. MMM Münchener Medizin Mechanik GmbH, Planegg, Germany) was used for the
fractionated vacuum and gravitation methods. The above work ow was determined by the tests in the test laboratory.
TheHandpiecehastocooldownatroomtemperature.
Do not use while still warm.
•TheControlUnit,theFootswitchandthereceiver(32)mustnotbesterilized.
•Areductionoftheindicateddryingtimeduringthesterilizationprocesscancauseirreversibledamageorreducethe
performance.
• Do not exceed the maximum sterilization temperature during the sterilization process. This can cause irreversible
damage or reduce the performance.
Afterreprocessingandbeforethenextuse,storetheHandpieceinsterilepackaginginadryplace,awayfromdust.
Make sure that the chosen detergents and/or disinfectants do not contain any of the below listed chemicals:
•organic,mineraloroxidizingacids(lowerlimitforthepH-value:5.5),
•strongbases(upperlimitforthepH-value:11,alkalineproductsarerecommended),
•organicsolvents(e.g.ether,ketone,benzine),
•oxidants(e.g.peroxides),
•halogens(chlorine,iodine,bromine),
•aromaticandhalogenatedhydrocarbon.
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Theindividualcomponentscanbereusedaslongastheyperformadequatelyandtheinstrumentscanbexedproperly,
providedthattheyareusedwithduecareandreprocessed,inspectedandpackedcorrectly.Any(further)useofdamaged
or contaminated instruments is on the sole responsibility of the user. The durability of the product largely depends
on careful handling during use and reprocessing, which is why the number of possible reprocessing cycles cannot be
determined.Themanufacturerdeclinesallliabilityincaseofnon-observanceoftheseinstructions.
Replacing fuses is to be performed only if they are damaged.
UseonlysuchfusesasindicatedinTable5.
Toreplacethefuses:
•removedefectivefuses.Fusesarelocatedinthedrawer(17)installedinthepowersocket(16)ofthedevice,
•newtime-delayfuses,thevaluesofwhichshouldbeselectedonthebasisofTable5,shouldbeinsertedintheslotsinthe
fuse drawer.
Table 5. Values of fuses intended for specic models of the Control Unit of Shaver System:
Pos.
1# 16-2050 2xT1,25AL250V
•Slidethefusedrawer(17)intothepowersocketofthedevice(16).Properinstallationwillbesignalledbyanaudible“click”
, the sound of latches closing in the drawer locking mechanism.
•Connectthepowercord.Thedevicecanberestarted.
For long-lasting and trouble-free operation of the device, the manufacturer imposes obligatory
inspections,whichshouldtakeplaceatintervalsofnolessthanevery12months(onceayear).
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Theinspectionconsistsof:
•checkingthetechnicalstateofthedevice,
•cleaningtheinteriorofcollecteddustandothercontaminants,
•measurementofoperationalparameters,
•performanceofanelectricalsafetytestinaccordancewithEN60601-1,
•softwareupdate.
Eachinspectioninvolvesasubsequentreport,whosecopywillbedeliveredtotheclientwiththedevice.Ifmalfunctions
are found during the inspection, the inspector will prepare an offer for removal of such defects, which will be sent to the
customerbye-mailorfax.
Thedevicemanufacturerprovideswarrantyandpost-warrantyserviceunderthefollowingconditions:
•adamageddeviceshouldbesentinitsoriginalpackagingdirectlytomanufacturer(addresscanefoundinlastpage
Manufacturer and serviceprovider data)ortolocal manufacturer’sdistributor,togetherwitha detaileddescriptionof
themalfunction.Theserviceproviderhastherighttorefusewarrantyrepairsofadeviceimproperlypackagedorinnon-
original packaging,
•undernocircumstancesrepairsshouldbecarriedoutbyunqualiedpersonnel.Onlythemanufacturerand/orauthorised
servicepartnersareauthorisedtoperformthem.Thedeviceisprotectedfromunauthorizedopeningbythewarranty
seals. A damaged or broken seal voids the warranty and implies to the manufacturer refusing any responsibility for any
subsequentmalfunctionsand/orlimitationsinthefunctioningofthedevice,
•themanufacturer’swarrantydoesnotcoverdamagecausedbyrandomeventssuchasooding,fall,powersurgecaused
byastorm,burninginareetc.,
•warrantyrepairsmaybecarriedoutsolelybytheequipmentmanufactureroranauthorisedserviceprovider,whose
address is given by the manufacturer,
•beforeshipping,decontaminatethedeviceanditsaccessoriesaccordingtochapter6“Maintenanceandcare“inorder
to protect the service personnel. Manufacturer and authorized service provider has the right to reject contaminated
products for repair.
Table 6. Specication of the most common problems associated with using the device and methods of their detection and
elimination:
Solution
Power cord is not connected Connectpowercordtothepowercablesocket(16)
No power at place of installation Make sure that the voltage in the power grid is correct
Damaged or missing fuse Checkfuses(Seepoint7.1.)
“POWERON/OFF”(15)switchwasnotactuated Afterinstallationactuate“POWERON/OFF”(15)switchattherear
panel of the Control Unit
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Solution
TheHandpiecewasnotconnectedtotheControlUnit
ConnecttheHandpiecetothesocket“HANDPIECE1(2)or
“HANDPIECE2”(3)orcheckthattheHandpieceisproperlylocked
in place
TheFootswitchwasnotconnectedtotheControlUnit connecttheFootswitchtothesocket“FOOTSWITCH”(4)orcheck
that the Footswitch is properly locked in place
TheotherHandpieceisactivated activatethesocketfortherequiredHandpiecebypressingthe
“TOOL”(10)buttonattheControlUnit
Solution
Blade is blocked in the Handpiece Replace the shaver blade for a well-functioning one
TheFootswitchhasnotbeenconnectedtotheControlUnit Connect the Footswitch to the Control
ToolowbatterylevelinthewirelessFootswitch Chargethebatteryaccordingtorecommendations(Seepoint4.5.)
Connection error between the Footswitch console and the receiv-
er
Re-initiate the connection procedure in accordance with paragraph
4.5.
Solution
Prolonged overloading of the Handpiece
Remove the Handpiece from the connection socket at the
Control Unit and allow to cool down to room temperature. Make
sure if installed shaver blade is not the cause of the Handpiece
overloading
Any anomalies or defects not included in the aforementioned table must be reported to the manufacturer’s service
department.Untilalldefectsofthedeviceareremoved,itshouldbeexcludedfromoperationandmarkedaccordingly.
Table 7. Control Unit technical specication:
Parameter Control Unit
Power consumption 65 VA
Supply voltage 100-240 V AC
Powerfrequency 50/60 Hz
Protection class Class I, application part type B
This manual suits for next models
2
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