noras or head holder flexibility & heidberg · noras or head holder flexibility & heidberg...

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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

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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

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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:




• 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

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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

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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)


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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)


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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)


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1 Set 113217 Multifunctional Bar System

(if applicable)

1 Set 113242 Sugita Adapter Set

(if applicable)

1 or 2 112986 Additional Fixation

(if applicable)


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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




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)


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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)


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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


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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

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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


1 117631 Pediatric One Point Fixation

(if applicable)

Processing instructions for all other NORAS OR Head Holder Components

16/26


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


17/26


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


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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)


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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


20/26


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


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10 112390 Multipurpose Screw

1 114505 Hinged Bracket, right

May not be disassembled from the base

plate

1 114504 Hinged Bracket, left


plate

1 114529 Locking Screw Z-Joint


plate

2 114883 Locking Screw Guidance Z-Joint


plate


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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)


23/26


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


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

[email protected]

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]

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