medical bees MB1-17-20 Series User manual

0483
Date
21 October 2021
CT/ MRI compatible MF-System
IFU GA-008-02
Revision
01
Page
Seite 1von 37
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

0483
Date
21 October 2021
CT/ MRI compatible MF-System
IFU GA-008-02
Revision
01
Page
Seite 2von 37
Content
1Conformities..................................................................................................................5
1.1 Guidelines and norms.............................................................................................. 5
1.2 CE conformity.......................................................................................................... 5
2General Safety Information...........................................................................................5
2.1 Symbols used for safety information........................................................................ 5
2.2 Proper handling....................................................................................................... 6
2.3 Permitted user......................................................................................................... 6
3Basic Information..........................................................................................................6
3.1 Warranty and liability............................................................................................... 6
3.2 Obligations of the purchaser.................................................................................... 6
3.3 Obligations of the user ............................................................................................ 7
3.4 Usage as per instructions........................................................................................ 7
3.5 Improper usage....................................................................................................... 7
4Product description ......................................................................................................7
4.1 General description................................................................................................. 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
5Mounting......................................................................................................................16
5.1 Mounting of the Table adapter with connecting arm ...............................................16
5.2 Mounting to operating table, adjustments...............................................................16
5.3 Mounting of the Swivel Adaptor..............................................................................17
5.4 Mounting of the Skull Clamp...................................................................................17
5.5 Mounting of the Horseshoe ....................................................................................17
6Usage and Handling....................................................................................................18
6.1 Using the Table adapter with connecting arm.........................................................18
6.2 Using the Swivel Adaptor .......................................................................................18
6.3 Using the Skull Clamp............................................................................................18
6.4 Using the Horseshoe Headrest ..............................................................................19
6.5 Detailed description of application..........................................................................19
6.6 Set-Up/ Assembly/ Instructions for use for CT-System...........................................23
Connection to OR-table...................................................................................23

0483
Date
21 October 2021
CT/ MRI compatible MF-System
IFU GA-008-02
Revision
01
Page
Seite 3von 37
Connecting to Maquet OR-table (CT-/ MRI compatible system)......................25
Skull clamp......................................................................................................27
Horseshoe.......................................................................................................29
6.7 Function and safety inspections .............................................................................30
Before clinical use...........................................................................................30
After clinical use..............................................................................................30
7Care..............................................................................................................................31
7.1 Preparation for decontamination.............................................................................31
7.2 Pre-cleaning process..............................................................................................31
7.3 Cleaning / 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 swivel adapter........................................................33
7.6 Supplementary information.....................................................................................33
8Maintenance and Repair .............................................................................................35
8.1 Service, repairs and return shipment......................................................................35
Service and Repairs........................................................................................35
Return shipment..............................................................................................35
8.2 Maintenance intervals ............................................................................................35
8.3 Maintenance to be performed by the purchaser .....................................................36
9Environmentally Compatible Disposal.......................................................................36
10 Appendix......................................................................................................................37
10.1 Manufacturer information........................................................................................37
10.2 Authorized distributor .............................................................................................37

0483
Date
21 October 2021
CT/ MRI compatible MF-System
IFU GA-008-02
Revision
01
Page
Seite 4von 37
Preface
Dear reader,
These instructions for use provide information on the following
aspects of the Premium MF-Headrest System:
•safety
•mounting/ 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. Please contact your authorized
distributor.
Storage:
This instruction manual contains important information on the safe, correct and efficient
usage of the Headrest System. Always keep this manual close to the device for easy
access and reference.

0483
Date
21 October 2021
CT/ MRI compatible MF-System
IFU GA-008-02
Revision
01
Page
Seite 5von 37
1 Conformities
1.1 Guidelines and norms
Description Guidelines and norms
MF- CT/ MRI compatible Headrest System COUNCIL DIRECTIVE 93/42/EEC
of 14 June 1993
1.2 CE conformity
The MF- CT/ MRI compatible Headrest System conforms to the basic requirements
of the applicable guideline and the corresponding norms of the Council of the
European Union.
2 General Safety Information
This instruction manual contains the basic information required for the safe usage of the
device.
2.1 Symbols 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 patient. Failure to observe this
information and follow the appropriate instructions may result in serious injury to the
patient and may even endanger the patient’s life.
Warning:
This symbol indicates a danger of injury to the user of the device.
Important:
This symbol indicates important information on the proper usage of the device. Failure
to observe this information and follow the appropriate instructions may cause damage
to the equipment.
Note:
This symbol provides tips concerning the usage of the device. Such information will
help you use the device to its full potential.