background image

L011-44

Page 6 of 9

2019-05-13

Rev. E1

Automated Cleaning Protocol: 

(Requires STar™ SteriSuite)

Platform Adapter Kit Sterilization instructions:

Method

Steam

Protocol

Gravity wrapped:

(in 2 Layers of 1-ply Polypropylene wrap 

[1]

)

Exposure Time: 30 minutes at 132°C (270°F)
Minimum Dry Time: 60 minutes

[1] Cycle was validated using Halyard Health H300 wrap

Prevacuum wrapped:

(in 2 Layers of 1-ply Polypropylene wrap 

[2]

)

Preconditioning Pulses: 3
Exposure Time: 4 minutes at 132°C (270°F)
Minimum Dry Time: 60 minutes

[2] Cycle was validated using Halyard 
Health H400 wrap

Prevacuum wrapped:

(in 2 Layers of 1-ply Polypropylene wrap 

[3]

)

Preconditioning Pulses: 3
Exposure Time: 18 minutes at 134°C (273°F)
Minimum Dry Time: 60 minutes

[3] Cycle was validated using Halyard Health H300 wrap

 User should be aware that the effects of unvalidated sterilization protocols could result in damage 

to the components and affect their functioning or performance. The STar™ Drive Adapter Kit is not 
validated for use with alternative sterilization protocols, and FHC does not recommend or endorse 
their use. Users with questions regarding this safety issue should contact FHC’s Technical Service 
Department at 1-207-666-8190.

Manual Cleaning Protocol:

 (Requires STar™ SteriSuite)

1.  Prepare the detergent according to manufacturer’s recommendations: Asepti Wash Plus liquid 

(2.5 ml per liter or 1/4 oz per gal), using warm tap water.

2.  Separate the Drive, positioners, hubs, and Lead Holder and immerse them in the wash solution 

for a minmum of 5 minutes. Actuate the devices during the soak.

3.  Using a clean soft cloth that has been soaked in the detergent, wipe the tray, and its insert, to 

remove any visible soil. Use a soft bristle brush and syringe to reach hard-to-clean areas.

4.  Place the Drive and its components back in the tray.
5.  Prepare the detergent in a sonication unit according to manufacturer’s recommendations: Asepti 

Wash Plus liquid (2.5 ml per liter or 1/4 oz per gal).

6.  Immerse the tray in the sonication unit and sonicate for a minimumof 10 minutes.
7.  Rinse all components with running reverse osmosis/de-ionized water to remove any residual 

detergent.

8.  Dry components using a clean soft cloth.
9.  Visually inspect to ensure all visible soil is removed.

Cleaning and Sterilization

Phase

Recirulation Time

Water Temperature

Ecolab Inc. Detergent

(2.5 ml/l or 1/4 oz/gal)

Ecolab Inc. Detergent

(2.5 ml/l or 1/4 oz/gal)

Pre-Wash 1

2:00 min

Cold Tap Water (16°C max)

N/A

N/A

Enzyme Wash

2:00 min

Hot Tap Water (43°C min)

Asepti Wash Plus

Sekusept AR

Wash 1

2:00 min

65.5°C (Set Point)

Asepti Wash Plus

Sekusept AR

Rinse 1

2:00 min

Heated Water (66.0°C)

N/A

N/A

Pure Water Rinse

0:10 min

Heated (66.0°C)

Asepti Rinse

Sekusept FNZ or 

Sekumatic Multiclean

Dry

7:00 min

115°C

N/A

N/A

Summary of Contents for STar 66-IT-VP-01

Page 1: ...Drive Adapter Kit for microTargeting Platforms With Intergrated Ring FHC Inc 1201 Main Street Bowdoin ME 04287 USA Fax 1 207 666 8292 24 hour technical service 1 800 326 2905 US Can 1 207 666 8190 FH...

Page 2: ......

Page 3: ...ev E1 2019 05 13 Table of Contents Indications for use Intended use and Other devices required Symbol Key Inventory Cleaning and Sterilization Illustrative Procedure Track Selection Track Offsetting C...

Page 4: ...tion electrodes or other instruments in the brain or nervous system Intended use STar Drive Platform Adapter Kit is intended for use by a neurosurgeon in an operating room environment to position and...

Page 5: ...fication Probe 66 IT VP 01 Inventory 1 3 2 4 5 6 7 8 9 10 12 A 13 14 15 16 11 Purchased Separately A STar Drive M E shown or STar Drive M A Various or STar Drive sold in kits The products referenced i...

Page 6: ...ding to manufacturer s recommendations Asepti Wash Plus liquid 2 5 ml per liter or 1 4 oz per gal using warm tap water 2 Separate the Drive positioners hubs and Lead Holder and immerse them in the was...

Page 7: ...latform using 2 screws at 90 degrees apart Make sure the hub is completely seated in the platform The hub will sit approximately 1 8 above the top surface of the platform 4 Use the burr hole entry mar...

Page 8: ...form MER and implant lead 10 Remove drive from positioner then remove platform 11 Use the standoff wrench to support the standoff while twisting the driver clockwise to secure it to the standoff Turn...

Page 9: ...using positions A H Examples 3mm Offset Positioner in the G position indicated by the dark blue dots in the offsetting chart 3mm Offset Positioner in the B position indicated by the magenta dots in th...

Reviews: