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IMPORTANT INFORMATION
Please Read Before Use
Instructions for:
THE GHAJAR GUIDE® – Five Piece
(Catalog Number 05-0002)
For Single Patient Use Only
Do Not Resterilize

Do Not use if packaging is damaged

Distributed by
NEURODYNAMICS, Inc.
P.O. Box 603 Lenox Hill Station
New York, NY 10021
212-334-6080
THE GHAJAR GUIDE® is a registered trademark of Neurodynamics, Inc.
Indications:
THE GHAJAR GUIDE® is designed to be used as a device only for frontal placement of an intraventricular catheter at ninety degrees to the skull surface by a physician. This device is for use with intraventicular catheters.

Warnings:
 This device is for SINGLE USE ONLY; DO NOT RESTERILIZE. Use aseptic technique in all phases of handling. Neurodynamics will not be responsible for any device that is re-sterilized, nor will we accept for credit or exchange any product that has been opened or tampered with.

Sterility:
The device is sterile unless the package has been opened or damaged.  Do not use if the sterile packaging has been damaged or tampered with.

Caution:
Federal Law (U.S.A.) restricts the sale of this device to a physician or by his order.

Warranty:
Neurodynamics, Inc., warrants that this medical device is free from defects in both materials and workmanship. THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. The user shall determine the suitability for use of this medical device for any surgical procedure.  Neurodynamics shall not be liable for incidental or consequential damages of any kind.

Definitions:
Please note- for purposes of these instructions catheters are defined as follows:
  • A “normal” catheter is one that does not have any accessories as an integral part of the catheter; accessories that would prevent the catheter from passing through the closed lumen of the insert.
  • A “unitized” catheter is a ventricular catheter that has other ancillary equipment as an integral part of the catheter or is designed with attachments that prevent it from passing through the closed lumen of THE GHAJAR GUIDE®.

Description of The Ghajar Guide® Five Piece (CAT#05-0002)

Figure 1                            


This device consists of a rigid tripod Base, and four Inserts:

For Normal Catheters use inserts
  • Large” for French 10 (3.25mm)
  • Medium” for French 8 (2.70 mm)
  • Small” for French 7  (2.60 mm)
  • Slotted” Insert  (3.25 mm)
For Unitized Catheters only use
  • Slotted” Insert  (3.25 mm)

The inner diameter of the Insert is marked on the insert flange of all inserts.

The slotted insert is for use with a ventricular introducer, a catheter with an incorporated stylet or any other style of unitized catheter.  THE GHAJAR GUIDE® is packaged sterile, with the “Large” Insert assembled in the Base.

Assembly, Loading and Placement Instructions for THE GHAJAR GUIDE® and Normal Catheters:

The following instructions are provided as a general guideline for the use of the device.  The physician, at his or her discretion, may alter the procedure in accordance with medical judgment and clinical experience.

Note:
Normal catheters can be used with any insert of THE GHAJAR GUIDE® Five Piece. 
Unitized catheters can only be used with the “slotted” insert of THE GHAJAR GUIDE® Five Piece.

Assembly of THE GHAJAR GUIDE® Five Piece
(#05-0002) for Normal Catheters:


The GHAJAR GUIDE® Five Piece should be assembled before loading the catheter. To insure proper fit the catheter and the insert must be matched correctly. Place the appropriate diameter insert into the tripod base. Positioning the insert as shown in Figure 2a with the short end in the tripod base or, if a shorter height is required, flip the insert around and place the long end of the insert in the tripod base as shown in Figure 2b.  In either case make sure the insert fits into the tripod base firmly and the small knob on the tripod base fits into the square cutout on the insert.

                                  Figure 2a                  Figure 2b

Figure 3
Loading Normal Catheters:
With stylet in place, insert a normal catheter through proximal lumen of the Assembled GHAJAR GUIDE® Five Piece.  The guide and catheter are now ready for use on the cranium. (Figure 3)

Suggested Instructions for Normal Catheter Placement:

Make a burr or twist drill hole in the mid-pupillary line, slightly anterior to the coronal suture. In adults this usually measures 10 cm above the nasion and 3 cm lateral to the midline; for ventricular shift, a move lateral to the midline placement (i.e. 4 cm) on the side of the ventricular shift may be needed.

Following dural puncture, hold the guide with the catheter firmly against the skull or scalp above the cranial hole. (Figure 4a)

With the free hand, manually advance the catheter into the ventricle.

Figure 4a     
The intracerebral catheter length will vary for different size craniums. (In the normal adult the optimal length is 5cm.)

Grasp the catheter through the base of the guide with forceps to prevent inadvertent movement.

Holding the catheter in place with the forceps, remove the guide and stylet with one motion. Test for cerebrospinal fluid (CSF) manometrics. (Figure 4b)

Figure 4b

Assembly, Loading and Placement instructions for THE GHAJAR GUIDE® and Unitized Catheters:

The following instructions are provided as a general guideline for the use of the device.  The physician, at his or her discretion, may alter the procedure in accordance with medical judgment and clinical experience.

Note:
Unitized catheters - catheters with attachments-can only be used with the “slotted” insert of THE GHAJAR GUIDE® – Five Piece (Cat# 05-0002).

Assembly of THE GHAJAR GUIDE® – Five Piece (#05-0002) for Unitized Catheters
The device should be assembled before loading the catheter. Place the slotted insert into the tripod base. Positioning the insert as shown in Figure 5a with the short end in the tripod base or, if a shorter overall height is required, flip the insert around and place the long end of the insert in the tripod base as shown in Figure 5b.  In either case make sure the insert fits into the tripod base firmly and the small knob on the tripod base fits into the square cutout on the insert.
Figure 5a                         Figure 5b

Figure 6
Loading a Unitized Catheter:

With stylet in place, insert a unitized catheter through proximal lumen of THE GHAJAR GUIDE® Five Piece with a slotted insert. The insert may be placed in the tripod base in either direction to facilitate as shown in Figures 5a and b.  The guide and catheter are now ready for use on the cranium. (Figure 6)
 
Suggested Instructions for Unitized Catheter Placement:

Make a burr or twist drill hole in the mid-pupillary line, slightly anterior to the coronal suture. In adults this usually measures 10 cm above the nasion and 3 cm lateral to the midline; for ventricular shift, a move lateral to the midline placement (i.e. about 4 cm) on the side of the ventricular shift may be needed.

Following dural puncture, hold the guide with the catheter firmly against the skull or scalp above the cranial hole.(Figure 7a)

     Figure 7a

With the free hand, manually advance the catheter into the ventricle.

The intracerebral catheter length will vary for different size craniums. (In the normal adult the optimal length is 5cm.)

Grasp the catheter through the base of guide with forceps to prevent inadvertent movement.

Holding the catheter in place with the forceps, disengage the guide from the catheter by slipping it off the side of the catheter or introducer. (Figure 7b)

Remove the stylet or ventricular introducer from the catheter (see the removal instructions of the catheter manufacturer). Test for cerebrospinal fluid (CSF) manometrics.
Figure 7b









Manufactured for Neurodynamics, Inc. under:
U.S. Patent No.:
4,613,324
4,821,716
4,931,056
6,206,885
International Patents:
Australia Pat. No. 572,400
Canada Pat. No.1,263,580
German Pat. No.P 3678927.5
Italy Pat. No. 869 03921.4
Japan Pat. No. 1,682,453
Switzerland Pat. No.869 03921.4
United Kingdom Pat. No.869 03921.4
EPC Pat. No.0,229,105
Other Patents Pending


Instructions available in
Five Piece PDF Five Piece PDF (1160 KB)


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