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.Deviceclassication 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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SHAVER SYSTEM


•Theoperatinginstructionshowshowtooperate,maintainandservicetheequipment,sothatitsworkinglifeisaslongas
possible. Proper service is essential for a long-term trouble-free operation of the device.
•Staffoperatingthedeviceshouldfamiliarisethemselveswiththecontentsofthismanualbeforeinstallationanduseof
the device, and those who have access to it.
•Thedevicecanonlybeoperatedbydoctorsorassistingstaffwithappropriatequalications.
•ThedeviceismadeupinIsafetyclass.
•Toavoidriskofelectricshockthedevicehastobeconnectedonlytoasupplyingnetworkwithprotective
earthing.
•Beforeconnecting the device tothepower outlet,make surethat the parametersof thepower gridare identicalto
thoseinthedevicespecications.Supplyvoltage,frequencyandpowerconsumptionarespeciedintheremainderof
the documentation and on the rear panel of the device.
•Donotexposethedevicetostronghumidityorrain.
•Neverusethedeviceintheenvironmentsofammableanestheticgases.
•Ifammablegases(includinganestheticgases)arereleasedinthevicinityofthedevice,thelattershouldbeimmediately
switched off and unplugged from the power socket.
•Toavoidoverheatingthedevice,ensurethatadequateventilationisprovidedbeforestartingthedevice.Itisrecommended
to maintain a min. 10cm clearance from the left, right and rear sides of the device.
•Undernocircumstancesopenthecoverofthedevicewhenitisconnectedtopower.Electricvoltageinsidetheunitcan
reach0.4kV.Electricshockmayresultinpermanentdisabilityordeath.
•NEVERplacethedevicenearhotsurfacesorareassubjecttovibrationorshock.
•Repairsofthedevice,otherthanthosespeciedinthisoperatinginstruction,canbeperformedonlybymanufacturer
or by an authorised service provider specied 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.
•ChargingofthebatteryofwirelessFootswitchshouldbecarriedoutoutsidetheoperationaltheatre.
•UndernocircumstancesopenthehousingofFootswitch.
•BatteryofwirelessFootswitchmustn’tbereplacedbytheuser.
•Incaseofanydisturbancesormalfunctionsinthefunctioningofthedevice,immediatelyturnitoffusingthepower
switchlocatedontherearpanel.Takingintoaccounttheaboveguidance,themanufacturerfeelsresponsiblefor
thesafetyandreliabilityofthedevice.Themanufacturerdoesnotassumeresponsibilityfordamageswhichhavearisen
through abuse or incompatible with the intended operation of the device.

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

ShaverSystem16-2050inallvariantshasbeenspecicallydesignedfordrivingofbladesandsurgicalcutters,whichare
used during treatments of orthopedic reconstruction by using an endoscopic method named arthroscopy.
Table1presentscomponentsofShaverSystem:
Table 1. Shaver System variants:
Pos. Shaver System 
1# 16-2050 Control Unit incl. Handpiece with manual lock and standard
Footswitch
Thedevicecanbeusedonlyfortreatment,suchas:arthroscopy.
Itistheuser’sresponsibilitytousethedeviceproperlyasintended.Notcomplyingtotheoperatinginstructionmayresult
in danger for the patient or any of users.

Table 2. Standard package contains.
Pos.  Article no. Qty.
1Shaver System 16-2050 1
2PowercordwithEUplug n/a 1
3Operating instruction n/a 1
4Spare fuses acc. to table 5 2
Thedeviceissuppliedinapackagethatshouldbekeptforpossiblefuturetransport.


The Shaver System Set has been classied as Class IIa in accordance with rule 9 of Directive MDD/93/42/EEC. Cited
standardsarespeciedinTable4.
Table 4. List of standards, to which the manufacturer referred to during conformity assessment.
No. Standard Description
1EN60601-1 MedicalelectricalequipmentPart1:Generalrequirementsforbasicsafetyand
essential performance1
2EN60601-1-2
MedicalelectricalequipmentPart1-2:Generalrequirementsforbasic
safetyandessentialperformance--CollateralstandardElectromagnetic
compatibilityRequirementsandtests
3ENISO14971 Medical devices. Application of risk management to medical devices

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SHAVER SYSTEM
4EN60601-1-6 MedicalelectricalequipmentPart1-6:Generalrequirementsforbasicsafety
and essential performance - Collateral standard: Usability
5ENISO62366 MedicaldevicesApplicationofusabilityengineeringtomedicaldevices
6ENISO62304 Medical device software - Software life cycle processes
7ENISO17664
SterilizationofmedicaldevicesInformationtobe
provided by the manufacturer for the processing of
resterilizable medical devices
8EN10993-1 BiologicalevaluationofmedicaldevicesPart1:
Evaluationandtestingwithinariskmanagementprocess
9EN10993-18 BiologicalevaluationofmedicaldevicesPart18:Chemicalcharacterizationof
materials
10 EN15223-1 MedicaldevicesSymbolstobeusedwithmedicaldevicelabels,labellingand
informationtobesuppliedPart1:Generalrequirements
11 EN980 Symbols for use in the labelling of medical devices
12 EN1041 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.
:switchesthedevicefroma“STANDBY”stateofenergysaving/sleeptoaworkingstateandvice
versa.
   : function key to switch the shaver blade in the Handpiece to anti-clockwise rotation. If
buttons(6)and(7)arepressedatthesametime,thedevicewillbeworkingintheoscillationmode.
:functionkeytoswitchtheshaverbladeintheHandpiecetoclockwiserotation.Ifbuttons(6)
and(7)arepressedatthesametime,thedevicewillbeworkingintheoscillationmode.
: stepwise reduction of the speed to the lower level of rotational speed.

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:stepwiseincreaseofthespeedtothenexthigherlevelofrotationalspeed.
: function key which enables switching between two connected tools. It is available only if both tools are
presentinsockets“HANDPIECE1”and“HANDPIECE2”.
11. : illumination corresponds to the following states:
 •the“Standby”LEDblinksatafrequencyof0.5Hz-thismeansthatthedeviceisina“Standby”state,
 •the“Standby”LEDilluminatescontinuously-thedeviceisswitchedonandworkingproperly.
 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. :powercablesocketwithfusedrawer.Thenominalvaluesforfusesarespeciedonthedevice
labelTable5.Itisimperativetodisconnectthepowercordduringmaintenance,cleaningorreplacementoffuses.
17. Fuse drawer: where protecting the device power supply fuses are installed. Changing the fuses is described in the
point 7.1.
:connectorforequalisingtheelectricalpotentialofthehousingof
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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SHAVER SYSTEM

: the shaver blades are securely engaged when the locking device has snapped shut
visiblyandclickingsoundcanbeheard.Theshaverbladecannotbereleased,notevenafterrepeatedpulling.
21. Valve control:toregulatetheextractionofsalinesolutionfromtheoperativesite.

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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

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SHAVER SYSTEM
:pedalbuttontoswitchtheshaverbladeintheHandpiecetoanti-clockwiserotation.Thenumberofrotations
dependsonthesetspeedwhichcanbeadjustedviatheUnitControlbuttons(8)and(9)orFootswitchbutton(34).
:pedalbuttontoswitchtooscillatingmode.Thenumberofrotationsdependsonthesetspeedwhich
canbeadjustedviatheControlUnitbuttons(8)and(9)orFootswitchbutton(34).Theoscillationfrequencydependson
settings.
32. FWD:pedalbuttontoswitchtheshaverbladeintheHandpiecetoclockwiserotation.Thenumberofrotationsdepends
onthesetspeedwhichcanbeadjustedviatheControlUnitbuttons(8)and(9)orFootswitchbutton(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.
:pedalbuttontoregulatethespeedoftheshaverbladeintheHandpieceduringuse.Eachtimethebuttonis
pressed,thespeedisincreasedtothenexthigherlevel.
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
individualFootswitchbuttons(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.
:usedtoconnectthecharger(45).Chargingshouldbedone outside ofthetreatmentroom. While
charging, functions of the Footswitch are disabled.
:ashingonbluediodesignalsthepropercommunicationbetweentheFootswitchconsoleandthe
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.

Thischapterdescribesthecorrectinstallationandstart-upofthedevice.Therststepisthecorrectinstallationofthe
ControlUnit.Thelanguageselectfeatureallowstheoperatortoselectthelanguageofhischoice.Ifthesubsequentsteps
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!

Beforeinstallation,makesurethatthedevicehassucientventilationbymaintainingaminimumdistanceof10cmfrom
the right, left and rear sides of the device.
Device installation:
•theonlyintendedpositionoftheControlUnitishorizontal,inwhichthedeviceisplacedonaatsurfaceonitsfourrubber
feet(12).Inaddition,adequateventilationaroundtheControlUnitmustbeprovided,
•theplaceofinstallationshouldbeaat,dryandcleansurface.Thiscanbeatable,shelfofanendoscopytrolleyorother
elements meant for installation of medical devices.
Connecting the device to power:
•connect,usinganappropriatelead,theequipotentialboltlocatedontherearoftheControlUnittoanequipotentialstrip.
Thecableinsulationshouldbeyellow-green,
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•connectthepowercordprovidedwiththedevicetothesocket(16)onthebackoftheControlUnit,
•plugthepowercordintothepowersocket.Thevoltageshouldbewithintherangeindicatedonthedevicelabel.
Turnonthedevice:
•Aproperlyinstalledandconnecteddeviceshouldbestartedusingthe“ON/OFF”switch(15)locatedontherearpanel.
The“STANDBY”button(5)willstartashingatafrequencyof0,5Hz,indicatingthatthedevicehasswitchedtostandby
mode.

•Oncethedeviceisinstandbymode(seechapter4.1.),presssimultaneouslyandholddownthe“SPEEDDOWN”(8)and
“SPEEDUP”(9)buttonswithyourrighthand.
•Stillholdingbuttons(8)and(9)brieypressthe“STANDBY”button(5)withyourlefthand.
•Onceyouareintherequiredmenu,youcanreleasethesebuttons.Youcannowselectthelanguageyourequire.Thelast
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,PolishandTurkish.Theselectedlanguagemustbeconrmedbypressingthebutton“TOOL”(10).
•Oncetheselectedlanguagehasbeenconrmed,thenextsettingscanbeselected:oscillationtimeandbrightnessofthe
VDFdisplay.Again,thesettingsareselectedbypressingthebuttons“SPEEDDOWN”(8)or“SPEEDUP”(9).Conrmsettings
withthebutton“TOOL”(10).Thecontrolunitmemorizesthesettingsandautomaticallyreturnstonormaloperatingmode.

•Theplug(26)attheendofthecableoftheHandpiecehastobeconnectedtooneofthesockets“HANDPIECE1”(2)or
“HANDPIECE2”(3)atthefrontpaneloftheControlUnit.UptotwoHandpiecescanbeconnectedtotheControlUnitatthe
same time.
•Theplug(26)oftheHandpieceismarkedwithanotchandareddot.Whenconnectingtheplug,makesurethatthered
dotontheplugisinthesamepositionasthereddotonsockets(2)or(3)oftheControlUnit.Thepinsinsidetheplug(26)
might otherwise get damaged.
•WhentheControlUnitisactivated(seechapter4.6.),theHandpieceisreadyforuse.TheHandpiececanbeoperatedvia
the Control Unit and/or the Footswitch.
TheControlUnitisprovidedwithaso-calledprioritycircuitfortheHandpiecethatwasconnectedrstirrespectiveof
whethersocket“HANDPIECE1”(2)or“HANDPIECE2”(3)waschosen.WhentwoHandpiecesareconnectedatthesame
time,activatetherequiredHandpiecebypressingthebuttonTOOL(10).