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SHAVER SYSTEM 

  

Make sure that this certificate 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 modified 

by anyone other than the authorized service personnel.
Medical devices regulations request the user of the device to carry out regular function and safety checks. As manufacturers, 
we recommend quarterly inspections which are to be carried out by hospital technicians or other authorized personnel. 

You will find 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

12.1. CHeCkIng THe pneumaTIC ConTrol (manual ConTrol/Double fooTSWITCH)

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:

Summary of Contents for 16-2080

Page 1: ...SHAVER SYSTEM Ackermann www ackermannsurgical com Double Roller Pump for Laparoscopy 16 2080 User Manual Double Roller Pump ...

Page 2: ...g 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 Setting up functional buttons control buttons and operation 10 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 9 Warning signals failure and fault description 12 10 Cleaning an...

Page 3: ... IRRIGATION for pneumatic manual control or double footswitch 5 Connector SUCTION for pneumatic manual control or double footswitch 6 Display bargraph SUCTION 7 Roller wheel IRRIGATION 8 Roller wheel SUCTION 9 Tube holder 10 Fuse box 11 Mains power switch 12 Mains connection 13 Equipotentiality 14 Label next check 15 Model identification plate ...

Page 4: ...tch Adapter duct with instrument connector autoclavable Certification 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 filled with fluid and where the volume of rinsing fluid is small in proportion to th...

Page 5: ...ormation Name and address Model No Serial No Failure description Error message The unit consists of Pos Specification Article no Qty 1 Suction Irrigation pump 16 2080 1 2 Test report n a 1 3 User manual n a 1 4 Silicone suction irrigation tubing set autoclavable 16 2080 100 1 5 Main cable Euro 2 m 15 1720 800 1 6 Fuses 15 1720 901 2 7 Suction irrigation cannula dia 5 10 mm autoclavable 16 2080 201...

Page 6: ...mains connection DANGER 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 certification GmbH Kriegerstraße 6 70191 Stuttgart Germany Equipotential equalising potential Caution Hazardous voltage Batch number Article num...

Page 7: ...segment Irrigation 19 Supply tube with connector for reservoir 20 Tube clamp 21 Spike connector 22 Adapter for instrument 23 Patient side tube section SUCTION for instrument 24 Pump segment SUCTION 25 Tube section for fluid collection receptacle Disassembled IMPORTANT The tube set may only be installed after the device has successfully performed a self test ...

Page 8: ...ated 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 fluid collection receptacle 6 5 Removing the tubing set Detach all connectors between the instrument and reservoir before detaching the tube from the...

Page 9: ...e irrigation and suction rates are proportional to the pressure applied to the buttons enabling a fine degree of control Pressing both buttons simultaneously has no effect Manual control with adapter duct A Suction irrigation cannula dia 5 mm B Suction irrigation cannula dia 10 mm C Blue button IRRIGATION D Suction irrigation duct E Red button SUCTION F Control connector IRRIGATION blue I SUCTION ...

Page 10: ...t 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 r...

Page 11: ... 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 Th...

Page 12: ...er 10 CLEANING MAINTENANCE 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 instructio...

Page 13: ...of the suction and irrigation performance are valid as guidelines for the user inspection 12 quarterly inspections 12 1 checking the PNEUMATIC CONTROL MANUAL CONTROL DOUBLE FOOTSWITCH 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 ...

Page 14: ...The irrigation procedure is activated 9 Pump fluid until fluid 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 bu...

Page 15: ...e 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 ...

Page 16: ... instructions are listed below Double Roller Pump for Laparoscopy 16 2080 14 CONTACT DETAILS Ackermann Instrumente GmbH Eisenbahnstrasse 65 67 78604 Rietheim Weilheim Germany Phone 49 0 7461 966 17 0 Fax 49 0 7461 966 17 70 E Mail sales ackermannsurgical com Web www ackermannsurgical com End of document ...

Page 17: ...Ackermann Page 17 18 SHAVER SYSTEM ...

Page 18: ...ietheim Weilheim Germany User_Manual 16 2080 Revision_06 21 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 ...

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