noras or head holder flexibility & heidberg · noras or head holder flexibility & heidberg...
TRANSCRIPT
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Date issued: August, 2015 Technical changes reserved.
NORAS OR Head Holder Flexibility & Heidberg
NORAS OR Head Coil Sets
Cleaning, Disinfection and
Sterilization Instructions
Revision 02
General Notes
2/26
Content
Content ............................................................................................................................................. 2
General Notes ................................................................................................................................... 3
Processing instructions for NORAS OR Head Coil Top-/Bottom Array Coils, Cables ......................... 4
Components of the NORAS OR Head Holder which always have to be sterilized ............................. 6
117566 Tray for Operation Parts (Sterile Parts) ............................................................................... 10
Components of the NORAS OR Head Holder which are not allowed to be sterilized ....................... 11
Processing instructions for the Pediatric One Point Fixation ............................................................ 15
Processing instructions for all other NORAS OR Head Holder Components ................................... 16
117567 Tray for Preparation Parts (Non-Sterile Parts) .................................................................... 24
Contact ............................................................................................................................................ 25
General Notes
3/26
General Notes
• The instructions must be followed as described. In case of inadequate cleaning,
disinfection or sterilization, the warranty claim will be terminated.
• Frequent processing can have an impact on these products (color changes), but do
not affect the function of the product.
Material Damage
In order to prevent the NORAS OR Head Holder / Head Coil from
any damages due to improper cleaning procedures, strictly follow
the instructions below and also strictly observe chapter 8 ‘Cleaning,
Disinfection and Sterilizing’ of the Operator’s Manual.
Wear and Tear of Components
• All movable and removable components have to be visually inspected for wear and tear prior to each treatment.
• Worn out parts must not be used and have to be discarded. Spare parts can be purchased from NORAS MRI products GmbH.
Please contact [email protected] for more information
Danger of infection
The instructions for disinfection and sterilization must be followed.
In the case of inadequate disinfection or sterilization, the operator
and/or the patient may get infected.
Advice
Use commercially available liquid disinfection solutions. For surface
disinfection, all disinfectants, which were tested and approved by
the Robert-Koch-Institute in Germany (www.rki.de) for 5 minutes
disinfection are suitable.
Processing instructions for NORAS OR Head Coil Top-/Bottom Array Coils, Cables
4/26
Processing instructions for NORAS OR Head Coil
Top-/Bottom Array Coils, Cables
Advice
No sterilization is required for all Top-/Bottom Arrays and Cables
• Remove excessive soiling with disposable dump (not wet) cloth/paper
• Manual disinfection with a lint-free moistened cloth
• Use Aldehyde-free surface disinfectants according to the instructions of the manufacturer
Advice
In case sterilization is required for Top-/Bottom Arrays and Cables at customer site, the following process is recommended:
• Remove excessive soiling with disposable dump (not wet) cloth/paper
• Manual disinfection with a lint-free moistened cloth
• Use Aldehyde-free surface disinfectants according to the instructions of the manufacturer
• Recommended sterilization procedure: H2O2 Plasma sterilization with Sterrad® 100S: 7 cycles, total cycle time 55min, cycle temperature max. 122°F (50°C)
• NOTE: Sterilization is reducing the lifetime of coils and cables
It is not allowed:
• to clean the Top-/Bottom Arrays and Cables in immersion baths or to hold under running water,
• to disinfect the Top-/Bottom Arrays and Cables with automated cleaning or disinfection (washer/disinfector),
• to steam sterilize the Top-/Bottom Arrays and Cables,
• to dry Top-/Bottom Arrays and Cables in a dryer,
• to use abrasive cleaners and other organic solvent-based cleaning and disinfectant solutions.
Handle the Top-/Bottom Arrays and Cables very carefully!
Cleaning liquids and water inside the connectors, traps or coil housing will destroy the electronics inside.
All Top-/Bottom Arrays and all Cables are not waterproof!
The maximum allowed temperature for all processing is
122°F / 50°C
Processing instructions for NORAS OR Head Coil Top-/Bottom Array Coils, Cables
5/26
Picture Part Number & Description
111921 NORAS OR Head Coil Top Array Philips 1.5T
114557 NORAS OR Head Coil Top Array Philips 3T
114497 NORAS OR Head Coil Top Array Siemens 1.5T
112893 NORAS OR Head Coil Top Array Siemens 3T
111922 NORAS OR Head Coil Bottom Array Philips 1.5T
114558 NORAS OR Head Coil Bottom Array Philips 3T
114491 NORAS OR Head Coil Bottom Array Siemens 1.5T
113719 NORAS OR Head Coil Bottom Array Siemens 3T
117126 Y-Cable Top/Bottom Array 1.5T Siemens Aera
115053 Y-Cable Top/Bottom Array 3T Siemens Skyra
113463 Y-Cable 1.5T Philips Ingenia
113447 Y-Cable 3T Philips Ingenia
112661 Cable C3 Top Array 1.5T Philips Achieva
112662 Cable C3 Bottom Array 1.5T Philips Achieva
113419 Cable C3 Top Array 3T Philips Achieva
113418 Cable C3 Bottom Array 3T Philips Achieva
Components of the NORAS OR Head Holder which always have to be sterilized
6/26
Components of the NORAS OR Head Holder which always
have to be sterilized
Advice
• Before sterilization, remove excessive soiling with disposable dump (not wet) cloth/paper
• Cleaning and disinfection with automated washer/disinfector is possible
• Recommended sterilization procedure: H2O2 Plasma sterilization with Sterrad® 100S: 7 cycles, total cycle time 55min, cycle temperature max. 122°F (50°C)
• Recommended steam sterilization procedure: 5 min. with a temperature of 273,2°F (134°C) and a pressure of 3,04bar
Picture Qty Part No. Part Name and Additional Information
12 114096 Skull Pin with big Tip
Use 117570 Special strainer basket for
small parts
6 117329 Skull Pin with small Tip
(if applicable)
Use 117570 Special strainer basket for
small parts
1 or 2 117570 Special strainer basket for small parts -
JF148R
For 114096 Skull Pin with big Tip and/or
117329 Skull Pin with small Tip (if
applicable)
Components of the NORAS OR Head Holder which always have to be sterilized
7/26
Picture Qty Part No. Part Name and Additional Information
1 117566 Tray for Operation Parts
2 114126 Clamp
4 113049 Screw for Clamp
1 112996 5 Pin Bolt Wrench, small
1 111815 VarioGuide Adapter
(if applicable)
Components of the NORAS OR Head Holder which always have to be sterilized
8/26
Picture Qty Part No. Part Name and Additional Information
1 or 2 113243 Leyla Adapter
(if applicable)
2
4
8
113393
113397
112390
All Purpose Arch
(if applicable)
All Purpose Arch Adapter
(if applicable)
Multi Purpose Screw
(if applicable)
1 114295 GREENBERGTM Retractor Adapter
(if applicable)
Components of the NORAS OR Head Holder which always have to be sterilized
9/26
Picture Qty Part No. Part Name and Additional Information
1 Set 113217 Multifunctional Bar System
(if applicable)
1 Set 113242 Sugita Adapter Set
(if applicable)
1 or 2 112986 Additional Fixation
(if applicable)
Components of the NORAS OR Head Holder which always have to be sterilized
10/26
117566 Tray for Operation Parts (Sterile Parts)
Standard delivery is indicated by yellow dots in the picture below.
Components of the NORAS OR Head Holder which are not allowed to be sterilized
11/26
Components of the NORAS OR Head Holder which are not
allowed to be sterilized
Advice
• Remove excessive soiling with disposable dump (not wet) cloth/paper
• Manual disinfection with a lint-free moistened cloth
• Use Aldehyde-free surface disinfectants according to the instructions of the manufacturer
It is not allowed:
• to clean the components below in immersion baths or to hold under running water,
• to disinfect the components below with automated cleaning or disinfection (washer/disinfector),
• to steam- or plasma sterilize the components below,
• using abrasive cleaners and other organic solvent-based cleaning and disinfectant solutions.
The maximum allowed temperature for all processing is
122°F / 50°C
Picture Qty Part No. Part Name
1 114232 Clamping Device
1 113467 Vacuum Mattress Head
(if applicable)
Components of the NORAS OR Head Holder which are not allowed to be sterilized
12/26
Picture Qty Part No. Part Name
1 113465 Aluminum Hand Pump
(if applicable)
1 117260 Base Plate Flexibility
1 114587 Head Frame Holder Flexibility
1 113053 Base Plate for Miyabi Shell
(if applicable)
1 113063 Base Plate for Maquet Transfer Board
(if applicable)
Components of the NORAS OR Head Holder which are not allowed to be sterilized
13/26
Picture Qty Part No. Part Name
1 113055 C-Arc Holder (for C-Arcs Revision 00 to
04 and Head Frame Heidberg)
1 SI7304 Height Adjustable C-Arc Holder (235 –
270 mm), only for Siemens Magnetom
Symphony and Espree with Rotating
Table
(if applicable)
1 114708 Head Frame Flexibility
1 117262 Head Frame Heidberg
1 113168 Thread Cleaner M6
Components of the NORAS OR Head Holder which are not allowed to be sterilized
14/26
Picture Qty Part No. Part Name
n/a n/a All types of cushions
(Sample Picture)
1 118166 Head Frame Cushion
1 113598 Phantom Holder
(if applicable)
1 117630
117990
117894
117988
117897
117899
Bore Gauge Alpha Maquet Plus US
Bore Gauge Alpha Maquet Plus EU
Bore Gauge Maquet Magnus EU
Bore Gauge Maquet Magnus, US
Bore Gauge TruSystem 7500, EU
Bore Gauge TruSystem 7500, US
(If applicable)
Processing of the Pediatric One Point Fixation
15/26
Processing instructions for the Pediatric One Point Fixation
Advice
No sterilization is required. The following processing is allowed:
• to remove excessive soiling with a disposable dump cloth/paper
• to do manual disinfection with a lint-free moistened cloth
• to use aldehyde-free surface disinfectants according to the instructions of the manufacturer
• to clean the fixation in immersion baths or hold it under running water,
• to clean and/or disinfect the components with automated cleaning or disinfection (washer/disinfector)
• to dry the components in a dryer
Advice
In case sterilization is required at customer site, the following process is recommended:
• For preparation, proceed as mentioned above
• Recommended sterilization procedure: o H2O2 Plasma sterilization with Sterrad® 100S:
7 cycles, total cycle time 55min, cycle temperature max. 122°F (50°C).
NOTE: Sterilization is reducing the lifetime
It is not allowed:
• To use abrasive cleaners and other organic solvent-based cleaning and disinfectant solutions.
• To steam sterilize the Pediatric One Point Fixation!
The maximum allowed temperature for processing is
122°F / 50°C
Picture Qty Part No. Part Name
1 117631 Pediatric One Point Fixation
(if applicable)
Processing instructions for all other NORAS OR Head Holder Components
16/26
Processing instructions for all other NORAS OR Head Holder Components
Advice
No sterilization is required for all of the below listed components.
The following processing is allowed:
• to remove excessive soiling with a disposable dump cloth/paper
• to do manual disinfection with a lint-free moistened cloth
• to use aldehyde-free surface disinfectants according to the instructions of the manufacturer
• to clean the components in immersion baths or hold it under running water,
• to clean and/or disinfect the components with automated cleaning or disinfection (washer/disinfector)
• to dry the components in a dryer
Advice
In case sterilization is required for those components at customer site, the following process is recommended:
• For preparation, proceed as mentioned above
• Recommended sterilization procedure: o H2O2 Plasma sterilization with Sterrad® 100S:
7 cycles, total cycle time 55min, cycle temperature max. 122°F (50°C) or
o Steam sterilization procedure: 5 min. with a temperature of 273,2°F (134°C) and a pressure of 3,04bar
NOTE: Sterilization is reducing the lifetime of the components
It is not allowed:
to use abrasive cleaners and other organic solvent-based cleaning and disinfectant solutions.
The maximum allowed temperature for using a dryer is
122°F / 50°C
Processing instructions for all other NORAS OR Head Holder Components
17/26
Picture Qty Part No. Part Name
1 117567 Tray for Preparation Parts
2 114210 Pin Holder with Lock Nut, small
2 114352 Pin Holder with Lock Nut, large
2 114128 Adjustment Nut Flexibility
3 112767 Knurled Nut
3 112764 Fixation Screw
Processing instructions for all other NORAS OR Head Holder Components
18/26
Picture Qty Part No. Part Name
2 114779 Two Point Fixation Plate Flexibility
2 117305 One- / Two Point Fixation Rod
1 112728 Drape Link Adapter
(if applicable)
1 114531 Medtronic Adapter
(if applicable)
1 112934 BrainLAB Interface rotating
(if applicable)
Processing instructions for all other NORAS OR Head Holder Components
19/26
Picture Qty Part No. Part Name
1 117869 BrainLAB Interface rotating 51
(if applicable)
2 114126 Clamp Flexibility
6 113049 Screw for Clamp
1 113920 Universal Angle Bracket
2 113410 Coil Column, short
Processing instructions for all other NORAS OR Head Holder Components
20/26
Picture Qty Part No. Part Name
1 113391 Coil Fixation Plate, short
2 112717 Column 65mm
(if applicable)
1 112696 Coil Fixation Plate 65mm
(if applicable)
2 112701 Coil Fixation Block
3 112820 Coil Fixation Disc
Processing instructions for all other NORAS OR Head Holder Components
21/26
Picture Qty Part No. Part Name
10 112390 Multipurpose Screw
1 114505 Hinged Bracket, right
May not be disassembled from the base
plate
1 114504 Hinged Bracket, left
May not be disassembled from the base
plate
1 114529 Locking Screw Z-Joint
May not be disassembled from the base
plate
2 114883 Locking Screw Guidance Z-Joint
May not be disassembled from the base
plate
Processing instructions for all other NORAS OR Head Holder Components
22/26
Picture Qty Part No. Part Name
1 114769 Central Nut Flexibility
1 114773 Sliding Block Flexibility
4 117458 Screw Maquet Flexibility
(if applicable)
4 113050 Screw Miyabi Shell
(if applicable)
1 113064 Maquet Screw Tool
(if applicable)
Processing instructions for all other NORAS OR Head Holder Components
23/26
Picture Qty Part No. Part Name
2 112996 5 Pin Bolt Wrench, small
1 113062 Hexagon Socket Wrench Miyabi Shell
(if applicable)
1 113048 5 Pin Bolt Wrench, Ball Handle
1 113047 Socket Wrench Central Nut
Processing instructions for all other NORAS OR Head Holder Components
24/26
117567 Tray for Preparation Parts (Non-Sterile Parts)
Standard delivery is indicated by yellow dots in the picture below.
Contact
25/26
Contact
NORAS MRI products GmbH
Leibnizstrasse 4
97204 Hoechberg
Germany
Tel.: +49 931 29927-0
Fax: +49 931 29927-20
www.noras.de
Your contact person regarding the iMRI Neurosurgery Solution:
Lutz Rabe
Tel.: +49 (0) 931 29927-22
Mobile: +49 (0) 173 6574209
E-Mail: [email protected]
Christian Zimmermann
Tel.: +49 (0) 931 29927-16
Mobile: +49 (0) 173 6669883
E-Mail: [email protected]