FHC Waypoint 66-IT-MR1 Directions For Use Manual Download Page 1

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Directions For Use

L011-61 (Rev F0, 2019-08-08)

Contains directions for the following products:
66-IT-MR1, 66-IT-MR3, 66-WP-ID, 66-WP-ID-01,
66-WP-ID-02, 66-WP-MR

WayPoint™ Inserter System

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

FHC Europe

(TERMOBIT PROD srl)
42A Barbu Vacarescu Str, 3rd Fl
Bucharest 020281Sector 2
Romania

FHC Latin America

Calle 6 Sur Cra 43 A-200
Edifi cio LUGO Ofi cina 1406
Medellín-Colombia

www.fh-co.com

Summary of Contents for Waypoint 66-IT-MR1

Page 1: ...MR WayPoint Inserter System 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 FHC Europe TERMOBIT PROD srl 42A Barbu Vacar...

Page 2: ......

Page 3: ...Warnings and Cautions Specifications Inventory Storage Cleaning Sterilization Height Chart 120mm 130mm Inserter Height Chart 120mm Inserter extended clearance Pre Use Check Illustrative Procedure MRI...

Page 4: ...re with FHC Inc 1201 Main Street Bowdoin Me 04287 USA Indicates the temperature limits to which the medical device can be safely exposed Indicates the range of humidity to which the medical device can...

Page 5: ...Display module 66 EL MS Remote control 66 EL RM USB cord N5 55 02 Power cord country specific 1 2 3 4 11 10 8 7 13 6 12 66 WP MR includes 6 Burr Hole Marker 7 Standoff Wrench 8 Hex Wrench 9 Manual Ha...

Page 6: ...od Container Manual Automated Tray fully loaded with parts in sonication unit with detergent Asepti Wash Plus liquid Reverse Osmosis de ionized water Use clean soft cloth Phase Recirculation Time in m...

Page 7: ...ull cycle Gravity wrapped in 2 layers of 1 ply polypropylene wrap 3 Exposure Time 30 minutes at 132 C 270 F Minimum Dry Time 60 minutes 3 Cycle was validated using Halyard Health H300 wrap Prevacuum w...

Page 8: ...L011 61 Page 8 of 25 2019 08 08 Rev F0 Shown with MR Lead Insertion Tube 66 IT MR1...

Page 9: ...Page 9 of 25 L011 61 Rev F0 2019 08 08 Shown with MR Lead Insertion Tube 66 IT MR1...

Page 10: ...d threads or looseness 4 Pull the stylet up 2cm out of the insertion tube Ensure that the stylet tip retracts into the insertion tube 5 Place the center hub into the integrated indexing ring Secure th...

Page 11: ...thumbknobs until the drape support is held securely 7 Secure the center positioner to the inserter 8 Install the insertion tube with stylet into the inserter When the inserter and positioner are moun...

Page 12: ...sertion tubes should always be carefully inspected before use because damage to them can cause targeting errors and impact patient safety Handle insertion tubes carefully to prevent bending 3 Install...

Page 13: ...61 Rev F0 2019 08 08 4 Insert burr hole marker bushing into center hub 5 Insert the burr hole marking tool down through the bushing 6 Create indentation in skin skull for location of burr hole and re...

Page 14: ...L011 61 Page 14 of 25 2019 08 08 Rev F0 7 Remove burr hole marker bushing 8 Remove platform and create burr hole 9 Reattach platform...

Page 15: ...r or erratic function is observed discontinue use of the WayPoint Inserter System immediately and evaluate the potential impact to patient safety before continuing its unmitigated use WARNING Always c...

Page 16: ...s in the unused indexing ring tapped holes and thread them in lightly 14 Mount the drape support as shown 15 Tighten the 8mm thumbknobs until the drape support is held securely The thumbknobs should b...

Page 17: ...or center trajectory remains constant regardless of orientation Four parallel tracks at 2mm orthogonal offset are achieved with alignment to locations A C E and G designated as the black dots below a...

Page 18: ...Loc to approximately 25 mm from the lead stylet handle making sure the lead is in the center notch of the LeadLoc 21 Release pressure on the LeadLoc WARNING Do NOT over pinch the tabs Over pinching th...

Page 19: ...pinching the LeadLoc move the lead so that the contacts are in the desired position relative to target depth Note When using the 120mm inserter extended clearance the depth stop will be positioned at...

Page 20: ...Remove the LeadLoc with lead from lead holder 27 Remove drape support by removing the two 8mm thumbknobs and then lifting the drape support straight up 28 Remove stylet Be sure to hold the collar of t...

Page 21: ...is not being used the lead should be placed down through the selected track 31 Carefully secure the LeadLoc and lead in the lead holder making sure the tabs of the LeadLoc align with the thumbknob on...

Page 22: ...ice like Medtronic Navigus cap 35 Remove the stylet from the lead 36 Loosen the lead holder thumbknob only slightly ensuring that it still retains the LeadLoc and that the LeadLoc cannot move vertical...

Page 23: ...manual handle 41 Place the hex wrench over the first anchor to be removed Drop the combination driver down into the hex wrench until it engages with the anchor Twist the hex wrench counterclockwise to...

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