medical bees MB1-17-20 Series Instructions For Use Manual Download Page 1

Page: 1 / 37

0483

Date

21 October 2021

CT/ MRI compatible MF-System

IFU GA-008-02

Revision

Page

Seite

von

Instructions for Use

CT/ MRI compatible

MF-Headrest/ Cranial

Stabilization and Fixation System

MB1-17-20X-XX

Medical Bees GmbH

Friedrich-Wöhler-Straße 13

78576 Emmingen-Liptingen

Germany

Summary of Contents for MB1-17-20 Series

Page 1: ...e MF System IFU GA 008 02 Revision 01 Page Seite 1 von 37 Instructions for Use CT MRI compatible MF Headrest Cranial Stabilization and Fixation System MB1 17 20X XX Medical Bees GmbH Friedrich W hler...

Page 2: ...ription 7 4 2 Components 8 Table adapter with connecting arm 8 Swivel Adaptor 9 Skull Clamp 9 Horseshoe 10 4 3 Mounting of additional parts 10 4 4 Technical specifications 11 5 Mounting 16 5 1 Mountin...

Page 3: ...disinfection 31 Manual cleaning process 31 Automatic cleaning disinfection process 32 7 4 Inspections 32 Maintenance and care of instruments 33 Packaging 33 7 5 Sterilisation of skull clamp and swive...

Page 4: ...ting assembly usage maintenance We continuously update our instruction manuals Your suggestions concerning this manual are welcome since they will help us make the manual even more user friendly Pleas...

Page 5: ...mbols used for safety information The symbols explained below are used in this instruction manual to point out safety relevant information Danger This symbol indicates a danger to the health of the pa...

Page 6: ...e free from defects in both materials and workmanship at the time of delivery Exclusion of liability The manufacturer shall not be liable for damages resulting from incorrect usage of the device failu...

Page 7: ...usage or usage not conforming to the instructions contained in this manual may result in serious injuries to the patient or the user and damage the device and other equipment Exclusion of liability Th...

Page 8: ...arm MB1 17 200 31 MB1 17 200 15 Swivel Adaptor MB1 17 200 26 or MB1 17 200 25 Skull Clamp Or Horseshoe headrest MB1 17 200 40 MB1 17 200 35 The system components consist of the following main parts T...

Page 9: ...Page Seite 9 von 37 Swivel Adaptor swivel base two retaining ring units clamping screw 2x M24 1x M16 Skull Clamp Skull Clamp base Skull Clamp extension assembly torque screw with Skull Pin holder rota...

Page 10: ...MB1 17 000 50 Skull Pins stainless steel Children MB1 17 000 52 Skull Pins Titanium Adult MB1 17 000 54 Skull Pins Titanium Children MB1 17 000 56 Skull Pins PEEK stainless steel Adult MB1 17 000 62...

Page 11: ...connecting arm 6250 g Swivel Adaptor 500 g Skull Clamp 1700 g Horseshoe 3450 g Material PEEK POM C aluminum cast stainless steel table adapter Dimensions see outline drawing The two end brackets of t...

Page 12: ...0483 Date 21 October 2021 CT MRI compatible MF System IFU GA 008 02 Revision 01 Page Seite 12 von 37 Fig 6 Outline drawing Swivel Adaptor Fig 5 Outline drawing Table adapter with clamp mount...

Page 13: ...0483 Date 21 October 2021 CT MRI compatible MF System IFU GA 008 02 Revision 01 Page Seite 13 von 37 Fig 7 Outline drawing Skull Clamp...

Page 14: ...0483 Date 21 October 2021 CT MRI compatible MF System IFU GA 008 02 Revision 01 Page Seite 14 von 37 Fig 8 Outline drawing Horseshoe...

Page 15: ...GA 008 02 Revision 01 Page Seite 15 von 37 Type of device CT MRI compatible Headrest System Weight Table adapter Maquet 2640 g Skull Clamp 1700 g Horseshoe 3450 g Material PEEK POM C Dimensions see o...

Page 16: ...o adjust the Table adapter with connecting arm 3 Adjust the left end bracket in such a way as to account for the distance between the two holders at the operating table Use the hex wrench which is loc...

Page 17: ...r retaining rings in such a way that they engage 3 Tightly close the upper clamping screw 5 5 Mounting of the Horseshoe Mounting the Horseshoe headrest to Swivel Adaptor 1 Turn upper clamping screw of...

Page 18: ...the Swivel Adaptor 3 Turn the Swivel Adaptor until you have obtained the desired position 4 Lock the Swivel Adaptor torque screw by applying an adequate force pressure 6 3 Using the Skull Clamp The S...

Page 19: ...rseshoe Headrest D Mount the holder 6 5 Detailed description of application A Adjust the Table adapter with connecting arm the Swivel Adaptor and the Skull Clamp to the patient s head position 1 Open...

Page 20: ...he rocker arm until the index knob engages 5 Turn the torque screw in order to drive the Skull Pins at an angle of 90 degrees into the patient s head refer to instruction manual Skull Pins section mou...

Page 21: ...evision 01 Page Seite 21 von 37 Note Before starting the case make sure that the rings are showing see Fig 10 When applying pressure less rings become visible The higher the force less rings become vi...

Page 22: ...dle can be turned into the desired position Danger The MF Skull Clamp may cause damage to the patient s skull The head may fall out of the Skull Clamp or the Skull Pins may break through into the brai...

Page 23: ...e the movable operating table connection arm on the rod 4 Insert the operating table connection rods into the holes of the operating table Or slide the clamping blocks over the OR table rails 5 If you...

Page 24: ...to the connecting arm 9 To have additional security and stability the screws should be tightened with these tools 10 Test this assembly to see if it is stable by pulling pushing turning If not check i...

Page 25: ...left when the clamping bolt is positioned concentrically in diameter 60 mm i e when the toothing grooves of the swing arm plate are exactly under the toothing grooves of the swivel plate Maximum adjus...

Page 26: ...ning clockwise to desired position 9 Loosen Screw 2 by turning it counterclockwise to be able to swivel the swing arm plate freely around the horizontal axis Lower turning position Upper turning posit...

Page 27: ...e arm of the skull clamp 12 Please note do not screw in too far otherwise no additional pressure can be built up Correct 13 Open Close Symbol By turning the beige twist handle the pin holder can be ro...

Page 28: ...spring loaded tensioning screw Build up pressure clockwise reduce pressure counter clockwise 17 After the skull clamp has been fixed to the head it is screwed to the swivel adapter The swivel adapter...

Page 29: ...4 The gel pads are clipped onto the horseshoe of the headrest Important The plastic holders of the gel pads must be clipped over the holder so that they are firmly fixed 15 The headrest is positioned...

Page 30: ...the transitional member is properly attached to the connecting arm assembly the teeth of attached system components engage properly the Skull Clamp base and extension assembly are properly engaged The...

Page 31: ...ng agent manufacturer Devices shall be placed in such a way as to cover all their surfaces cavities lumens and openings Afterwards the devices shall briefly 15 s be flushed with cold water Movable par...

Page 32: ...C Water draining Rinse for 2 minutes in demineralised water 40 C The special instruction manuals of automatic washer disinfector manufacturers shall be followed Automatic disinfection Automatic therma...

Page 33: ...fect is also excluded Packaging The devices are single packed in a packaging tailored to each device and standard conformable provided to sterilisation acc to DIN EN ISO 11607 or DIN EN 868 standards...

Page 34: ...0483 Date 21 October 2021 CT MRI compatible MF System IFU GA 008 02 Revision 01 Page Seite 34 von 37...

Page 35: ...nt for repair service In addition the products shall be appropriately marked as hygienically safe or not decontaminated 8 2 Maintenance intervals The purchaser shall be obliged to send the device to t...

Page 36: ...h connecting arm may cause the adjustable parts to loosen Make sure that all beige screws can tighten firmly 9 Environmentally Compatible Disposal The purchase or user is responsible for rendering the...

Page 37: ...cal bees GmbH Friedrich W hler Str 13 D 78576 Emmingen Phone 49 7465 929831 0 Fax 49 7465 929831 1 E mail info medical bees de Internet http www medical bees de When you do not reach us directly with...

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