ACKERMANN 16-2080 User manual

SHAVER SYSTEM
Ackermann
www.ackermannsurgical.com
• Double Roller Pump for Laparoscopy #16-2080
User Manual
Double Roller Pump

DOUBLE ROLLER PUMP FOR LAPAROSCOPY
Ackermann
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CONTENTS
1. Front and rear panel 3
 
3. Intended use 
 
 
 
6.1. Composition 6
6.2. Reprocessing of reusable tubing set 6
6.3. Illustration of reusable tubing set 7
6.4. Inserting the tubing set 8
6.5. Removing the tubing set 8
6.6. Using the device in operating room 8
7. Adapter duct - pneumatic control 9
 
8.1. Setting up 10
8.2. Functional test 10
8.3. Control buttons 11
8.3.1. AC Power switch 11
8.3.2. On, off 11
8.3.3. Start, stop 11
8.4. Operation of the device 11
 
 
 
12. Quarterly inspections 13
12.1. Checking the pneumatic control 13
 12.2.Checkingtheowrate 14
13. Appendix 16
 

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SHAVER SYSTEM
1. FRONT AND REAR PANEL
1 Push button ON/OFF
2Push button START/STOP
3Display bargraph IRRIGATION
Connector IRRIGATION for pneumatic manual
control or double footswitch
 Connector SUCTION for pneumatic manual
control or double footswitch
6Display bargraph SUCTION
7Roller wheel IRRIGATION
8Roller wheel SUCTION
9Tube holder
 Fuse box
11 Mains power switch
12 Mains connection
13 Equipotentiality
 Label next check
Modelidenticationplate

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2. TECHNICAL SPECIFICATIONS
Parameter 
Power consumption 36 W
Supply voltage 100-240 V/AC - Mains fuse T 3,15 A
Power frequency 50/60 Hz
Classicationacc.toEUdirective93/42/EEC Class IIa
Type acc. to DIN EN 60601-1:2005 BF
Protection class acc. to DIN EN 60601-1:2005 I
Manufactured acc. to DINEN60601-1(03.1996)
EMC DINEN60601-1-2(199-05)
Irrigation capacity 0 - 3000 ml/min
Suction capacity 0 - 3000 ml/min
Pressure range 0 - 750 mm Hg
Conditions Temperature: +10°C to +40°C
Humidity: 30% to 70%
Case protection IPX1
Tubing sets Silicone - autoclavable
Dimensions 300(W)x93(H)x260(D)mm
Weight ca. 5 kg
Optional Pneumatic double footswitch
Adapter duct with instrument connector, autoclavable
Certication CE0483
3. INDENTED USE
The device a suction-irrigation pump without pressure monitoring and is used in minimal invasive surgery. It can be
utilizedinallareasofendoscopicsurgicaloperationprocedureswherethebodycavitiesarenotcompletelylledwith
uidandwherethevolumeofrinsinguidissmallinproportiontothevolumeoftheanatomicalcavity.Thepumpsystem
is well suited for utilization in the abdomen, thorax and retroperitoneum.
The irrigation process of the pump system can, apart from the classic application, also act as a suction device for fumes
whicharisewhenlaserandHF-devices are deployed.Theuseofspecialcannula (punction)alsoenhances theeldof
application for the pump system.
The irrigation and the suction performance can be steadily set to requirement by the operating surgeon at the manual-

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control instrument by using two press buttons or with double footswitch.
The controlling concept for the pump system enables the operator to do without mechanically susceptible and, during
cleaning, troublesome trumpet valves.
ATTENTION! The utilization in small and closed body cavities (arthroscopy and hysteroscopy), in which the irrigation
process could lead to uncontrolled and dangerous increases of pressure, is strictly forbidden.

The pump system and delivered accessories are to be immediately inspected on receipt for completeness and possible
external damage. Claims for damage are only accepted if the supplier or authorised partners are immediately informed.
If a return delivery of the pump system should be necessary, please use the original packaging.
Please enclose the following information:
•Nameandaddress
•ModelNo./SerialNo.
•Failuredescription
•Errormessage
The unit consists of:
Pos.  Article no. Qty.
1Suction-Irrigation pump 16-2080 1
2Tes t re por t n/a 1
3User manual n/a 1
4Silicone suction-irrigation tubing set, autoclavable 16-2080-100 1
5Main cable Euro 2 m 15-1720-800 1
6Fuses 15-1720-901 2
7Suction-irrigation cannula, dia. 5 / 10 mm, autoclavable 16-2080-201/-202 1
8Adapter duct, autoclavable 16-2080-203 1
9Pneumat. manual control with double-lumen control tube, autoclavable 16-2080-200/-204 1

Please make yourself familiar with this unit according to description in the user manual.
Please note:
•Thisdeviceisforuseonlybyqualiedmedicalpersonnelwhicharetrainedinitsuseandtheapplicablemedicalprocedure.
•Thephysicianisresponsiblefortheappropriatetypeofushingliquid.
•Useonlyoriginalaccessories.
•Serivceandmaintenancehavetobecarriedoutonlybyauthorizedpersons.
•Donotusethedevicewithindemarcatedhazardzones!(explosivegases).

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•Liabilitymaybevoidedbymisuse,abuse,violationofinstructionsforuse,omissionofrequiredmaintenance,opening
theequipmentmodications,repairsbyunauthorizedpersons!Useofotherthanoriginalaccesaccessoriesshallvoid
warranty and liability.
•Equipmenthastobeusedatalltimesinaccordancewiththeoperatinginstructions!
ThisdevicecomplieswithcurrentlyvalidEMVstandards.HowevertestsofEMVstandardDINEN60601-1-2:1993-05are
carried out. Nevertheless, EMV interference may lead to malfunctioning. If malfunctioning is observed, ensure that the
device has been installed and is being operating in accordance with EMV guidelines for use supplied with the device. Note
thatportableandmobilehigh-frequencycommunicationequipmentmay inuencetheoperation ofthisdevice. If the
device is used in the vicinity of or stacked together with other devices, the device or system must be monitored to ensure
standard use in accordance with these guidelines. If necessary, notify the manufacturer of the corresponding details.
IMPORTANT! Incaseoffailureswitchoffthedeviceatitsmainpowerswitch(1).Pullmainsconnection.
Do not open the unit. No user-servicable parts inside.
Symbol and description Symbol and description Symbol and description
Follow the instructions for use Type BF applied part Year of production
Legal manufacturer
mdcmedicaldevicecerticationGmbH,
Kriegerstraße 6,
70191Stuttgart,Germany
Equipotential
(equalisingpotential)
        C a u t i o n! 
Hazardous voltage Batch number Article number
Do not use if package is
damaged
Spray protection (protection
againstverticallyfallingdrops) Protective earthing
Product contains phthalate


The tube set comprises two separate, color-coded tubes.
Thebluetubeisusedforirrigationandtheredoneforsuction.Bothtubesarettedwithcoloredrings(blueandred).
Youwillndacoloredringattubestopperofpumpsegment,seesection6.3.
Toinsertthecorrecttubesyouwillndcorrespondingcolor-codingonthedevice’stubeholderinblueandred.

All components of the reusable tube set can be autoclaved at a maximum temperature of 134°C and pressure of 2 bar.
Thetubesetcanbedismantled(seesection6.3.),butmustbecompletelyreassembledanddriedbeforesterilization.
IMPORTANT! Whenttingtogetherthetubeset,pleaseensurethatthereisatight,leak-proofconnectionbetweenthe
adapter and the tube sections.
0483

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
Assembled:
16 Patient-side tube section - IRRIGATION - for
instrument
17 Adapter
18 Pump segment - Irrigation
19 Supply tube with connector for reservoir
 Tube clamp
21 Spike connector
22 Adapter for instrument
23 Patient-side tube section- SUCTION- for instrument
 Pump segment - SUCTION
Tubesectionforuidcollectionreceptacle
Disassembled:
IMPORTANT! Thetubesetmayonlybeinstalledafterthedevicehassuccessfullyperformedaselftest!

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
Tubing set has to be completely assembled and sterile, see chapter 6.3.
Step 1:
Taketheblueirrigationtube.Placethetubestopper(blue)inthe
uppertubeholder(markedblue).Pullthepumpsegmenttaught
around the roller wheel and route it through the lower tube holder
untilthesecondtubestopper(colorless)locksrmlyintoplace.
Ensure the tube stoppers are correctly seated.
Step 2:
Taketheredsuctiontube.Placethetubestopper(red)intothe
uppertubeholder(markedred).Proceedasdescribedinstep1.
Step 3:
Next, connect all connectors on the suction and irrigation tubes
totheinstrument,tothereservoirandtotheuidcollectionreceptacle.

Detach all connectors between the instrument and reservoir before
detaching the tube from the roller wheels.
Take the pump segment of the red suction tube out of the tube holder
rst,andthenthepumpsegmentoftheblueirrigationtube.
Reconditionreusabletubesetsforlateruse(seesection6.2.)


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7. ADAPTER DUCT - PNEUMATIC CONTROL
Thepneumaticcontrolcontrolsthepump’ssuctionandowrate.
Theadapter ductis optionallysuppliedwithtwo cannulaswhichareattached tothe handgripby a threadedtting.If
necessary, the cannula can even be changed during the operation.
The suction-irrigation duct is able to rotate in relation to the manual control. Once the cannula/instrument has been
inserted,thesuction-irrigationductautomaticallyndsapositionthatavoidskinkingthetube.Thisensuresconstant
availability of the full suction-irrigation capacity.
The manual control can be separated from the adapter duct, which enables the pump system to be controlled by an
assistant.
The double-lumen control tube must be connected between the device and the manual control.
There are blue and red color-coded control connectors on the manual control and on the front of the device.
Connect the blue-coded control tube to the blue-coded control connector and the red-coded tube to the red-coded
connector.
Themanualcontrolisttedwithtwobuttons.Thebluebuttonactivatestheirrigationfunction,theredbuttonthesuction
function.
Theirrigationandsuctionratesareproportionaltothepressureappliedtothebuttons,enablinganedegreeofcontrol.
Pressing both buttons simultaneously has no effect.
Manual control with adapter duct:
A Suction-irrigation cannula dia. 5 mm
BSuction-irrigation cannula dia. 10 mm
C Blue button - IRRIGATION
DSuction-irrigation duct
E Red button - SUCTION
FControlconnector(IRRIGATION(blue)ISUCTION(red))
Small adapter for tubing set - IRRIGATION
HDouble-lumen control tube
IBig adapter for tube set - SUCTION
JTubingset-IRRIGATION(blue)
KTubingset-SUCTION(red)
LInstrument connector
As an alternative to the pneumatic manual control, it is also possible to operate the pump using the pneumatic double
footswitch.
The two control lines must be connected between the device and the pneumatic double footswitch. There are blue and
red color-coded control connectors on the rear of the double footswitch and on the front of the device. Connect the blue-
coded control line to the blue-coded control connector and the redcoded line to the red-coded connector.
The double footswitch is equipped with a left and a right footswitch. The left switch activates the irrigation function, the red
switch the suction function. The irrigation and suction rates are proportional to the pressure applied to the footswitches,
enablinganedegreeofcontrol.Pressingbothfootswitchessimultaneouslyhasnoeffect.
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Pneumatic double footswitch:
MLeft footswitch- IRRIGATION
NControlconnector-IRRIGATION(blue)
Controlconnector-SUCTION(red)
PRight footswitch - IRRIGATION


1. Plug the AC plug into an AC outlet and switch on the device using the AC power switch. The STANDBY LED light yellow.
2. Find a suitable location for the double footswitch if required, and connect it to the device. Ensure that the tube is not
kinked or compressed. If you do not require the double footswitch and wish to use the manual control, then connect this.
Thetubesetmustnotbeinplacebeforetheselftestorbeinstalledwhiletheselftestisinprogress!
3. Activate the device by pressing the push button ON/OFF .
4. The device performs a self test.
Self test sequence:
a. All lights come on for 1 sec and then go out again.
b. The left and right bargraph show the software version for 1 sec.
c. 1st segment of the left bargraph display lights: checking the pressure sensor for pneumatic control
d. 2nd-5th segments of the left bargraph light up: checking the irrigation function of the motor
e. 6th-8th segments of the left bargraph light up: checking the suction function of the motor
f. All segments are unlit again. The device signals that is it is ready for operation with a triple beep signal and the ON and
STOP LEOs light.
5. Now install the tube set as described in section 6.4.
6. Carry out a functional test.
8.2. FUNCTIONAL TEST
Eachtimethedeviceisused,afunctionaltestmustbecarriedoutrst.
1 . Start the pump by pressing the push button START/STOP. The START LED light green.
2.PressingtheIRRIGATIONbuttononthepneumaticcontrolcausesuidtobepumped.Bleedthetubesetuntiluidexits
from the end of the instrument.
3. Pressing the SUCTION button on the pneumatic control causes the suction roller to rotate.
4. The functional test is complete. Stop the pump by pressing the push button START/ STOP. The STOP LED light yellow.
The device is now ready for operation.

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8.3. CONTROL BUTTONS
8.3.1. POWER SWITCH
The AC power switch is used to switch the device on and off.
8.3.2. ON/OFF
The push button ON/OFF activates/deactivates
the device.
To activate device:
Press the push button ON/OFF. The ON LED light
green and the STANDBY LED goes out.
To deactivate device:
Press the push button ON/OFF. The STANDBY
LED light yellow and the ON LED goes out.
8.3.3. START/STOP
The push button START/STOP puts the device
into operation and stops it.
To start device:
Press the push button START/STOP. The START LED
light green and the roller wheels can be set in motion
using the pneumatic control.
To stop device:
Press the push button START/STOP. The STOP LED
light yellow and the START LED goes out.
The pneumatic control is inactive.

1 . You can start the device after carrying out a functional check.
2. The pump is activated, the ON LED light green, the STOP LED light yellow.
3. Start the pump by pressing the push button START/STOP. The START LED light green.
4. Pressing the red button on the manual control I right footswitch on the double footswitch starts the SUCTION roller
wheel moving and pressing the blue button left footswitch the IRRIGATION roller wheel. The stronger the pressure exerted,
thegreatertheowrate(canbeseenonthethebargraphdisplays).Ifpressureonthebuttonisreleased,thepumpstops.
The suction and irrigation processes cannot both take place at the same time. After every irrigation process lasting longer
than1.5sec,therollerwheel(IRRIGATION)turns1revolutioninthereversedirectioninordertopreventtheirrigationuid
from dripping.
5. Stop the device by pressing the push button START/STOP. The STOP LED light yellow.
6. Deactivate the device by pressing the push button ON/OFF. The STANDBY LED lightyellow.
7. Switch off the device at the AC power switch.

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
•IfabeepsignallastingforthreesecondssoundsandalltheLEDsareashing,thereisafaultwiththedevice.
a. The pump stops immediately and cannot be restarted. Deactivate the device by pressing the ON/OFF button. Remove
the tube set and reactivate the device after 15 seconds. The device then performs a self test.
b. If the roller wheel cannot be moved using the pneumatic controller, the control line is leaking or the connections have
become detached. To check for leaks, rst deactivate the device by pressing the ON/OFF button. Pull the end of the
control line away from the device and then reinsert it in the device shortly afterwards. Remove the tube set and reactivate
the device after 15 seconds. The device then performs a self test.
•Furtherpossiblereports
a.Self teststopsatrstsegmentofleftbargraphdisplay.Resultofpressuresensorcheckofpneumaticcontrolisnegative.
Deactivate the device by pressing the ON/OFF button. Pull the end of the control line away from the device and then
reinsert it in the device shortly afterwards. Remove the tube set and reactivate the device after 15 seconds. The device
then performs a self test. The device signals that is it is ready for operation with a triple beep signal and the ON and STOP
LEDs light up. Now proceed as described in section 8. If the self test fails again, please notify the relevant service partner.

To preserve the device and ensure its proper function please note as follows:
Cleaning of the device:
Please switch off the device after use. Remove the power cable from the AC outlet. Then remove the power cable from
the AC connector on the rear of the device. A disinfectant solution may be used to clean the exterior of the device. Please
consultthemanufacturer’sinstructionsfortheconcentrationofthesolution.
ATTENTION! Thedevicemustnotbesterilizedunderanycircumstances!
Cleaning of the manual control, adapter duct and instruments:
The manual control, adapter duct, instruments and the tube system are cleaned in the same way as is usual for surgical
instruments. Cleaning in washers is also permissible. For cleaning, the suction/irrigation cannulas and the tubes should
bedetachedfromthehandgrip.Pleaseensurethatnouidremainsinthecontroltubeorinthehandgrip.Thedisinfection
process prior to sterilization should not exceed one hour in duration. All methods of sterilization are permissible.
ATTENTION! The maximum values if steam sterilization is used should not exceed a temperature of 134°C and a pressure
of 2 bar.
11. SERVICE
The device must be inspected by authorized service personnel once a year.
The entire repair work, calibrations and other servicing may only be carried out by authorized service personnel.
The manufacturer is relieved of any liability for the operational safety of the device if these points are not observed.
Fortheannualinspectionorrepairwork,theownerofthemachinemustreceiveacerticatefromtheservicepersonnel
in view of the type and extent of services performed.

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Makesurethatthiscerticateishandedoverandthatalabelisattachedtotherearsideofthedevicestatingthedateof
the next inspection.
Themanufacturerisrelievedofanyliabilityfortheoperationalsafetyofthedeviceifitisopened,repairedand/ormodied
by anyone other than the authorized service personnel.
Medicaldevicesregulationsrequesttheuserofthedevicetocarryoutregularfunctionandsafetychecks.Asmanufacturers,
we recommend quarterly inspections which are to be carried out by hospital technicians or other authorized personnel.
Youwillndadescriptionoftheuserinspectioninthenextchapteroftheseoperatinginstructions.
Before delivery, a complex function and safety test is conducted by the manufacturer for every device. The results of this
quality control are documented in the inspection protocol, which is supplied with the device. The values of the suction and
irrigation performance are valid as guidelines for the user inspection.
12. QUARTERLY INSPECTIONS

For this test you will need:
•Thedevice
•Pneumaticcontrol(manualcontrol/doublefootswitch)
The pneumatic controller test procedure is carried out in the following steps:
1. Plug the AC plug into an AC outlet and switch on the device using the AC power switch. The STANDBY LED light yellow.
2.Connectthepneumaticcontrol(manualcontrol/doublefootswitch)tothedevice.Ensurethattheconnectionistight
and there are no leaks.
3. Activate the device by pressing the push button ON/OFF.
4. The device performs a self test.
5. Start the device by pressing the push button START/STOP. The START LED light green.
6.Pressingthemanualcontrol(blueorredbutton)Idoublefootswitch(leftorrightfootswitch)setstheassociatedroller
wheel(SUCTION/IRRIGATION)inmotion.
If this does not happen, repeat the procedure. If the second attempt also fails, please contact the relevant authorized
service partner.
Setup of functional test of pneumatic control:

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
For this test you will need:
•Thedevice
•Newtubeset
•3,5litermeasuringbeakerwithscale(A)
•Waterreservoirwith3,0litersofwater(B)
•Manualcontrol/doublefootswitch
•Adapterductwithcannulaconnected
•Awatchthatdisplaysseconds,orastopwatch
Thesuctionandirrigationowratetestprocedureiscarriedoutinthefollowingsteps:
1. Plug the AC plug into an AC outlet and switch on the device using the AC power switch. The STANDBY LED light yellow.
2.Connectthepneumaticcontrol(manualcontrolIdoublefootswitch)tothedevice.Ensurethattheconnectionistight
and there are no leaks.
3. Activate the device by pressing the push button ON/OFF.
4. The device performs a self test.
5. Now install the tube set.
6.Immersetheendofthesupplytubeinthewaterreservoir(B)andtheendofthetubesectionfortheuidcollection
receptacleinthemeasuringbeaker(A).Theendsmustbepositionedtolieonthebottomofthereceptacle.
7. Start the device by pressing the push button START/STOP. The START LED light green.
8.Pointthecannulaoftheadapterductintothemeasuringbeaker(A)andpressthebluebuttononthemanualcontrol/
the left footswitch on the double footswitch. The irrigation procedure is activated.
9.Pumpuiduntiluidexitsfromtheendofthetubeinthemeasuringbeaker(A).Continuetopumpuntilthereisapprox.
300 ml water in the measuring beaker. Stop the irrigation procedure by pressuring the push button START/STOP. The
STOP LED light yellow.
10.Immersethedistalendofthecannulainthecollectedwaterinthemeasuringbeaker(A).Presstheredbuttononthe
manual control / the right footswitch on the double footswitch to suck back up approx. threequarters of the contents. The
entiretubesystemisnowlledwithwater.
11.Returnthewatercollectedinthemeasuringbeaker(A)backtothewaterreservoir(B).Thenhavethewatchreadyfor
measuring the exact time that elapses.
1 2. Start the irrigation process by pressing and holding down the blue button on the manual control / left footswitch on the
doublefootswitchforexactly1minuteatmaximumow.Attheendofthistime,theremustbe3,0litersofwater(-15%to
+5%)inthemeasuringbeaker(A).
1 3. Now start the suction process by pressing the red button on the manual control / the left footswitch on the double
footswitch.Now,alsoatmaximumpower,pump(suction)thewateroutofthecontaineragain.Attheendofthistime,the
measuring beaker must be pumped practically empty.
Iftheamountofliquidpumpedisoutside(greaterorlessthan)thetolerances,repeattheprocedures.Ifthesecondattempt
also fails, please contact your authorized service partner.
Setupofowratetest:

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12. ACCESSORIES
Item # Description Illustration Quantity
16-2080-100 Silicone irrigation tubing set,
autoclavable 1 pc.
15-1720-800 Main cable Euro 2m 1 pc.
15-17209-00 Fuses 10 pcs.
16-2080-201 Suction-Irrigation cannula
dia. 5 mm, autoclavable 1 pc.
16-2080-202 Suction-Irrigation cannula
dia. 10 mm, autoclavable 1 pc.
16-2080-203 Adapter duct, autoclavable 1 pc.
16-2080-200 Pneumatic manual control,
autoclavable 1 pc.
16-2080-204 Double-lumen control tube,
autoclavable 1 pc.
16-2080-1000 Pneumatic double footswitch 1 pc.

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13. APPENDIX
All product codes covered by these instructions are listed below:
•Double Roller Pump for Laparoscopy 


Eisenbahnstrasse 65-67
78604 Rietheim-Weilheim
Germany
Phone: +49(0)746196617-0
Fax: +49(0)746196617-70
E-Mail: [e-mail]
Web: www.ackermannsurgical.com
End of document

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
Eisenbahnstrasse 65-67
78604 Rietheim-Weilheim
Germany

Copyright by Ackermann Instrumente GmbH. Specifications, design and accessories in this user manual are subject to change without any
notice or obligation on the part of the manufacturer.
Ackermann
0483