TECHNICAL BULLETIN 07-004

ORTHOXP MECHANICAL STOP FAILURE

1 Initial Information
Product: All OrthoXP systems
Technical Bulletin Number: 07-004
Priority: High
Category: Critical
Issue Date: March 2007
Units Affected: All OrthoXP systems
Deadline Date: Immediately

Please ensure all personnel working on IDC equipment are notified about this
important bulletin.
Please complete the attached Fax Back Sheet and return it to Imaging Dynamics by
fax to 1.403.251.1771.
If you have any questions or concerns, please call the IDC Help Desk, toll-free
1-866-XPLORER (1-866-975-6737) or e-mail service@imagingdynamics.com.
This bulletin can also be downloaded through the IDC tracking site under the project of
IDC-Service Technical Bulletins.

Imaging Dynamics Company • March 29, 2007 • Technical Bulletin: 07-004 v1.0
 2 • Revision History

2 Revision History

Revision Number Revision Date Details

Draft March 29, 2007 Draft Approved.

1.0 March 29, 2007 Document released.

3 Issue Description
The mechanical stop on the crossbeam of the OrthoXP may fail causing the crossbeam to
rotate freely. If excess weight is applied to the crossbeam, the setscrew may loosen causing the
mechanical stop to fail. This failure is dangerous because the crossbeam is free to rotate and
injure a patient or damage the equipment. See Figure 1-1.

Figure 1-1

4 Resolution Description
The following instructions describes how to replace the hexagon setscrew on the OrthoXP
crossbeam. The hexagon setscrew with flat point DIN 913 M8 x 8 must be replaced with a
hexagon socket head screw DIN 912 M8 x 12 in order to prevent the mechanical stop from
failing.

5 Materials and Tools

• Thread Lock
• Adjustable torque wrench with an extension and M4 hexagon end
• Replacement hexagon socket head screw DIN 912 M8 x 12
• Force Meter

Imaging Dynamics Company • March 29, 2007 • Technical Bulletin: 07-004 v1.0
 Safety Considerations • 3

6 Safety Considerations
• Two people are required to complete this procedure
• Take caution when removing the original setscrew. Once it has been removed, the
crossbeam can freely rotate.

7 Work Instructions
1. Remove the access cover on the crossbeam to access the inside of the crossbeam.

Figure 1-2

2. Rotate the crossbeam until the M4 setscrew is easily accessible. Make note of the rotation
angle of the crossbeam. Setting the same rotation angle will be necessary when re-installing
the new screw.

WARNING! Once the setscrew is removed, the crossbeam can freely rotate.

3. Designate one person to secure the crossbeam while the other person removes the setscrew.
Once the screw is removed, the flat portion of the rotation bar should be visible through the
tapped setscrew opening.

Imaging Dynamics Company • March 29, 2007 • Technical Bulletin: 07-004 v1.0
 4 • Work Instructions

Figure 1-3

4. Apply the thread lock to the new hexagon socket head screw DIN 912 M8 x 12.
5. Designate one person to rotate the crossbeam to the noted rotation angle, ensuring the flat
portion of the rotation bar is visible.
6. Install the new screw.
7. Tighten the screw to a torque of 15.0 Nm (130 in*lbs). See Figure 1-4.

Figure 1-4

NOTE: Ensure the torque is checked every six months once this procedure has been
completed.

8. Ensure the crossbeam is counter balanced by dis-enganging the brake and testing the pull
strength required to rotate the crossbeam. The value should be approximately 24–26 N
(5.3–5.9 lbs or 2.42–2.65 kg).

Imaging Dynamics Company • March 29, 2007 • Technical Bulletin: 07-004 v1.0
 Contact • 5

8 Contact
North American Contact
Imaging Dynamics Company
151, 2340 Pegasus Way, NE
Calgary, Alberta
T2E 8M5, Canada
IDC Help Desk, toll-free 1-866-XPLORER (1-866-975-6737)
E-mail service@imagingdynamics.com.
Fax 1-403-251-1771

European Contact
IDC Europe B.V.
Victorialaan 15, 5213 JG, s-Hertogenbosch
The Netherlands
Tel: +31(0)73 751.1742
Fax: +31(0)73 751.1744

Asian Contact
IDC Beijing Rep. Office
Room 1007A China Resource
No.8 Jianguomenwai Bei Avenue
Beijing 100005, China
Tel 00 86 10 85192196
Fax 00 86 10 85192198

Imaging Dynamics Company • March 29, 2007 • Technical Bulletin: 07-004 v1.0
 FAX BACK RECEIPT
Please fax this form back to IDC to acknowledge receipt of Technical Bulletin 07-004
OrthoXP Mechanical Stop Failure and to confirm implementation of this Service Technical
Bulletin.
Fax to: Imaging Dynamics
Address: Suite 151, 2340 Pegasus Way NE
Fax #: 1-403-251-1771
Attention: Service Administrator

Implementation of Technical Bulletin 07-004

Date Implemented:
From (Company):
From (Name):
Fax Number: Phone Number:

Site Location Serial Number of System Completed

Comments