Cleaning, Disinfection and Sterilization Manual...Brainlab Adapter – LUCY (Optional Accessories)...

OR

Head H

old

er

LU

CY

& N

OR

AS

OR

Head C

oil

Set

Date of Issue: November 2018 Technical changes reserved

OR Head Holder LUCY with Head Coil Set

Siemens 1.5T REF. 119734

OR Head Holder LUCY with Head Coil Set

Siemens 3T REF. 119736

Cleaning, Disinfection and

Sterilization Manual Ref. 119691

Revision 02

Content

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Content

1 General Notes ................................................................................................................ 3

2 Preparation instructions for NORAS OR Head Coil Top-/Bottom Arrays and Cable ........ 4

3 Pieces of the OR Head Holder, which need to be sterilized ............................................ 6

4 Arrangement in the Tray for Surgery pieces LUCY (Ref. 119692) .................................. 8

5 Pieces of the OR Head Holder LUCY, which must not be sterilized ................................ 9

6 Preparation instructions for all pieces of the OR Head Holder LUCY .............................12

7 Contact ..........................................................................................................................16

General Notes

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1 General Notes

The instructions stated, need to be followed. The warranty claim expires with wrong cleaning,

disinfection or sterilization of the product.

Frequent preparation might have an influence in the product´s visual appearance (color

changes), but will not influence the function of the product.

Use commercial, not organic disinfection solutions. For surface disinfection, all disinfection liq-

uids, which were tested and licensed by the Robert Koch Institution (www.rki.de) for 5 minutes

disinfection can be used.

Material damage

In order to prevent damages at the OR Head Holder LUCY and the NORAS

OR Head Coils, caused by improper cleaning and disinfection methods, follow

the below regulations as well as the instructions in chapter 8 “Cleaning, Disin-

fection and Sterilization” in the instruction manual.

Erosion of the components

All adjustable and removable components need to be checked visually before

every treatment, in order to control erosion of the parts.

Outworn pieces must not be used, but has to be disposed. Spare parts can be

ordered from NORAS MRI products GmbH.

For further information, please send an E-Mail to: [email protected]

Danger of Infection

The instructions of cleaning, disinfection and sterilization has to be undertaken.

With insufficient cleaning, disinfection or sterilization, the user and or the pa-

tient can be infected.

Preparation of NORAS Head Coil Set and Cable

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2 Preparation instructions for NORAS OR Head Coil

Top-/Bottom Arrays and Cable

Sterilization of the NORAS OR Head Coils and Cable is not necessary.

1. Remove the surface stains with a damp (not wet) non reusable cloth or paper cloth.

2. Manual disinfection with a damp, fiber-free cloth.

3. Use aldehyde free surface disinfection fluids, respectively to the instructions of the manufacturer.

If a sterilization of the Top-/Bottom Arrays and Cable is necessary for the user, follow-

ing process is recommended:

1. Remove the surface stains with a damp (not wet) non reusable cloth or paper cloth


3. Use aldehyde free surface disinfection fluids, respectively to the instructions of the manufacturer.

4. Recommended Sterilisation Procedere:

H2O2 Plasma sterilization with STERRAD®

Note

Sterilization lowers the live cycle of the Coils and Cables.

Is is not permitted to

Clean the Top-Bottom Arrays and Cable in a dipping bath or hold them under floating water.

Mechanically clean or disinfect (cleaning/disinfection device) the Top-/Bottom Arrays and cable

Steam disinfect the Top-/Bottom Arrays and cable

Dry the Top-/Bottom Arrays and cable mechanically

Use adhesives or other organic cleaning and disinfection fluids

Handle the Top-/Bottom Arrays and cable with care.

Cleaning fluids and water in the plugs, wave blockers or Coil cases de-stroys the electric.

All Top-Bottom Arrays and cables are not waterproof!

Preparation of NORAS Head Coil Set and Cable

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The maximum allowed temperature for preparation is 140°F / 60°C.

Table 1: Head Coils and Cables

Image Ref. Description and additional information

114497

112893

NORAS OR Head Coil Top Array Siemens 1,5T

NORAS OR Head Coil Top Array Siemens 3T

114491

113719

NORAS OR Head Coil Bottom Array Siemens 1,5T

NORAS OR Head Coil Bottom Array Siemens 3T

117126

115053

Y-Cabel Top/Bottom Array 1,5T Siemens Aera

Y-Cabel Top/Bottom Array 3T Siemens Skyra

Pieces of the OR Head Holder, which need to be sterilized

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3 Pieces of the OR Head Holder, which need to be

sterilized

The parts shown in table 2 need to be sterilized before use.


2. The mechanical cleaning or rather disinfection with a cleaning or disinfection device, regarding

Regulation ISO 15883 is possible.

3. Recommended sterilization method:

H2O2 Plasma sterilization with STERRAD®:

4. Steam disinfection: We recommend the use of a sterilization device regarding the regulations

ISO/TS 17665-3

Table 2: Pieces of OR Head Holder LUCY, which need to be sterilized


114096 Skull Pin with big tip

(Optional Accessories)

119692 Tray for Operation Parts LUCY

119371 Clamp LUCY

Just the used two clamps need to be sterile.


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Table 2: Pieces of OR Head Holder LUCY, which need to be sterilized


112996 5 Pin Bolt Wrench small


119671 VarioGuideTM Adapter


113243 LEYLA Retractor Socket


119675

119678

119374

All-Purpose Arch LUCY


All-Purpose Arch Adapter - LUCY


Clamping Screw - M10 long


114295 GREENBERGTM Retractor Adapter



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4 Arrangement in the Tray for Surgery pieces LUCY

(Ref. 119692)

The standard delivered items are marked yellow in the following picture.

Pieces of the OR Head Holder LUCY, which must not be sterilized

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5 Pieces of the OR Head Holder LUCY, which must not

be sterilized

Pieces shown in table 3 must not be sterilized. Conduct the cleaning and disinfection

as followed:



Use aldehyde free surface disinfection fluids, respectively to the instructions of the manufac-

turer.

Is is not permitted to

Clean the Top-Bottom Arrays and Cable in a dipping bath or hold put them under floating water.

Mechanically clean or disinfect (cleaning/disinfection device) the Top-/Bot-tom Arrays and cable

Steam disinfect the Top-/Bottom Arrays and cable

Dry the Top-/Bottom Arrays and cable mechanically

Use adhesives or other organic cleaning and disinfection fluids

The maximum allowed temperature for preparation is 140°F / 60°C.


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Table 3: Parts of the OR Head Holder LUCY, which must be sterilized.

Image Ref. Description

119029 One-point Fixation with Force Indicator Adult LUCY

119024 Base Plate LUCY Maquet

119663 Head Frame Holder LUCY

119358 Head Frame LUCY

n/a All pillows

(example picture)

118166 Head Frame pillow

119588 Phantom Holder LUCY


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119466 Bore Gauge LUCY

Preparation instructions for all pieces of the OR Head Holder LUCY

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6 Preparation instructions for all pieces of the OR Head

Holder LUCY

Pieces, shown in Table 4 do not need to be sterilized. Following preparation is ac-

ceptable.

1. Remove the surface contamination with a damp non reusable cloth / tissue.

2. Manuel disinfection with a damp, fiber free cloth.

Use aldehyde free surface disinfection fluids, according to the instructions of the manufac-

turer.

3. Cleaning of all pieces in dipping bath or under running water.

4. Mechanical cleaning and or disinfection (cleaning or disinfection device). We recommend the

use of a cleaning-disinfection device regarding the Norm ISO/TS 17665-3.

5. Mechanical drying of the components in RDG-E. The drying time need to be amended with

plastic pieces or a drying afterwards with medical compressed air need to be conducted.

If a sterilization of the pieces is wished by the costumer, following process is recom-

mended:

1. For preparation, follow the above steps.

2. Recommended Steam Disinfection method:

H2O2 Plasma sterilization With STERRAD®

Steam Disinfection: We recommend the use of a cleaning-disinfection device regarding

the Norm ISO/TS 17665-3

Note

Sterilization reduces the product life cycle.


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It is not permitted to use

abrasive and other organic cleaning and disinfection solutions

The maximum allowed temperature for mechanical drying is

140°F / 60°C.

Table 4: All other pieces for OR Head Holder LUCY


119340 Bottom Coil Retainer LUCY

Steam sterilisation is not permitted

119032 Two-point Fixation LUCY

119371 Clamp LUCY


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119394 Coil Column Lucy

119396 Coil Fixation Plate LUCY

119592 Locking Screw LUCY

119594 Locking Screw - M10 set

119595 Central Nut LUCY

119597 Sliding Block LUCY

119659 Socket Wrench LUCY


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112820 Coil Fixing Disc

112390 Multipurpose Screw

119668 Navigation System Adapter LUCY

119591 Brainlab Adapter – LUCY


119694 Medtronic Interface LUCY


119649 Fixation Head Frame Holder LUCY

Contact

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7 Contact

NORAS MRI products GmbH

Leibnizstraße 4

97204 Hoechberg

Germany

Phone.: +49 931 29927-0

Fax: +49 931 29927-20

[email protected]

www.noras.de

Cleaning, Disinfection and Sterilization Manual...Brainlab Adapter – LUCY (Optional Accessories)...

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