Tracer® Registration Probe, Passive
Rx Only
Product Information & Instructions
Intended Use
Instruments used with the Medtronic Computer Assisted Surgery System are intended as aids for precisely locating anatomical features in
either open or percutaneous procedures. The distal tip of the instruments can be an anatomic pointer for surgical stereotactic navigation.
The Medtronic Computer Assisted Surgery System is intended as an intra-operative adjunctive aid for the diagnostic image display and
presentation of localization information. The system is not intended to replace or supplant the standard and proven methods used by
the surgeon prior to or during surgery. The system is not intended as a replacement for standard lm to diagnose and plan surgery, nor is
the system intended to replace or relieve the surgeon’s responsibility for intra-operative guidance and procedural decision-making. The
system is a tool that provides adjunctive information to aid the surgeon during the decision-making process.
Device description
Tracer Registration Probe, Passive (REF # 960360) is a rigid instrument used for localization with a Medtronic Computer Assisted Surgery
System. The instrument is tted with a passive array for instrument tracking. Passive markers are sold separately.
Contraindications
Medical conditions which contraindicate the use of this instrument with the system include any medical condition which may be
contraindicative for the surgical procedure itself. This may, for example, include pregnancy, if surgery itself poses risks to the developing
fetus.
Warnings
• Ensure that the passive markers are fully seated, to avoid inaccuracies in navigation position. Do not use damaged, worn, or occluded
markers.
• Care must be exercised during handling and cleaning of instruments with sharp points or edges to prevent personal injury.
• Local burning of patient, physician, or other personnel may result from current paths through conductive elements like metal
instruments. Contacting conductive elements with an active cautery may cause undesired tissue heating and burns.
• Bending, prying, excessive force or misuse may result in the breakage or failure of the instrument, resulting in possible harm to patient
or user.
Precautions
• Exercise care during handling, storage, and cleaning to prevent deformation of the instrument tip. If the device is bent or damaged,
the instrument becomes unusable because it will not verify on a Computer Assisted Surgery System.
• Do not modify instruments
Operation
Ensure the instrument-specic software is installed on the system prior to rst use.
To install software on the Computer Assisted Surgery System, contact Medtronic Navigation Technical Support at 1-800-595-9709.
Cleaning
Instruments must be cleaned and sterilized prior to rst use and before each reuse. Cleaning should be performed as soon as possible
after each case. Remove any instrument tip protectors prior to cleaning and sterilization.
1. Remove passive markers if present and dispose of properly.
2. Thoroughly rinse instruments with deionized water.
3. Prepare a cleaning solution of lukewarm* enzymatic-neutral pH* detergent and deionized water per detergent manufacturers
instructions (*less than 43° C, pH 7.0-8.5).
4. Soak for a minimum of two minutes .
5. Rinse thoroughly with deionized water for one minute minimum.
6. Prepare a new cleaning solution of lukewarm* enzymatic-neutral pH* detergent and deionized water per detergent manufacturers
instructions (*less than 43° C, pH 7.0-8.5).
7. Clean ultrasonically in cleaning solution for at least 10 minutes.
8. Scrub instruments while submerged in cleaning solution with a soft instrument brush to remove blood and tissue if necessary.
Caution: Do not use wire brushes or scouring pads on the instruments.
9. Rinse thoroughly with deionized water for one minute minimum and ush blind holes and lumens. Dry immediately with
compressed air and/or a clean lint free cloth.
10. Examine device components for visible soil. If visible soil is observed, repeat cleaning.
Sterilization
The following cycle has been validated by Medtronic and is compatible with the instruments. It is the responsibility of each health care
facility to properly maintain and calibrate their equipment.
Warning
• Sterilization does not replace cleaning. Sterilization is only eective on clean items.
• If the tray is used, it should only contain the intended instruments. Adding additional instruments will aect sterilization ecacy and
dry time.
Caution
• Cold soak in glutaraldehyde, chlorine, ammonium solution, or dry heat sterilization is not recommended as damage to the instrument
nish may occur.
• The passive markers cannot be sterilized. They are single use items.
Prevacuum
• Temperature: 132°C (270°F)
• Steam time: Five (5) minutes
• Minimum dry time: Two (2) minutes*
• Wrapped or unwrapped (Flash) conguration**
Gravity
• Temperature: 132°C (270°F)
• Steam time: Fifteen (15) minutes
• Minimum dry time: Two (2) minutes*
• Wrapped or unwrapped (Flash) conguration**
2
Prevacuum (outside the United States)
REF
LOT
Rx Only
• Temperature: 134°C (273°F)
• Steam time: Eighteen (18) minutes
• Minimum dry time: Two (2) minutes*
• Wrapped or unwrapped (Flash) conguration**
* Minimum dry time is required with wrapped congurations only
** Flash sterilization should only be performed following proper cleaning and decontamination.
Alternately, any validated steam sterilization process with temperature up to 135 °C (275 °F) may be used.
Inspection
Check the condition of the instruments before and after each case. End of service life will be shown by any of the following conditions:
• Deformation preventing verication.
• Irremovable stain.
• Incomplete instrument; missing parts.
• Poorly working instrument.
Remove any instrument with these conditions from service immediately for disposal or repair.
Returns and repairs
DO NOT repair instruments. Contact Medtronic Customer Service to obtain a Return Goods Authorization number (RGA#) prior to shipping
the Product to Medtronic. Please have the original invoice number or purchase order number available to assist in verifying warranty
information. The RGA# should be prominently displayed on the box and included on all paperwork enclosed with the return and/or repair.
All Product returned to Medtronic should be safely packed in protective wrapping. For contaminated instruments, clean, sterilize, and
label before returning to Medtronic.
Customer must supply the Purchase Order number; the correct shipping and billing address; and either a completed Repair Order Form or
a statement of the problem or reason for return.
For Customer Support and Repair contact:
Medtronic Navigation
826 Coal Creek Circle
Louisville, CO 80027
800-595-9709
720-890-3200
Limited Warranty
A. This Limited Warranty provides the following assurance to the purchaser of a Tracer Registration Probe, hereafter referred to as the “Product”:
1. Should the Product fail to function within Medtronic’s published specications due to a defect in materials or workmanship within a period of
ninety (90) days, commencing with the delivery of the Product to the purchaser, Medtronic will at its option: (a) repair or replace any part or
parts of the Product; (b) issue a credit to the purchaser equal to the Purchase Price, as dened in Subsection A(2), against the purchase of the
replacement Product; or (c) provide a functionally comparable replacement Product at no charge. When a Product is replaced, any replacement
item becomes the property of the purchaser and the replaced item becomes the property of Medtronic. When a refund is given, the refunded
Product becomes Medtronic’s property.
2. As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or replacement
Product.
B. To qualify for the repair, replacement or credit set forth in Section A, the following conditions must be met:
1. The Product must be used on or before its “Use By” or “Use Before” date, if applicable.
2. The Product must be used in accordance with its labeling or documentation and must not have been modied or subjected to misuse, abuse,
accident or improper handling.
3. Medtronic must be notied in writing within thirty (30) days following discovery of a defect.
4. The Product must be returned to Medtronic within thirty (30) days after notication provided for in B(3) above. Medtronic may, at its option,
repair the Product on site.
5. The Product must not have been repaired or altered outside in any way which, in the sole judgment of Medtronic, aects its stability or reliability.
C. This Limited Warranty is limited to its express terms. In particular:
1. TO THE MAXIMUM EXTENT PERMITTED BY LAW, THIS LIMITED WARRANTY AND THE REMEDIES SET FORTH ABOVE ARE EXCLUSIVE AND IN LIEU
OF ALL OTHER WARRANTIES, REMEDIES AND CONDITIONS, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED. MEDTRONIC SPECIFICALLY
DISCLAIMS ANY AND ALL IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE. IF MEDTRONIC CANNOT LAWFULLY DISCLAIM OR EXCLUDE IMPLIED WARRANTIES UNDER APPLICABLE LAW, THEN TO THE
EXTENT POSSIBLE ANY CLAIMS UNDER SUCH IMPLIED WARRANTIES SHALL EXPIRE ON EXPIRATION OF THE WARRANTY PERIOD. TO THE MAXIMUM
EXTENT PERMITTED BY LAW, MEDTRONIC IS NOT RESPONSIBLE FOR DIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING
FROM ANY BREACH OF WARRANTY OR CONDITION, OR UNDER ANY OTHER LEGAL THEORY. No person has any authority to bind Medtronic to any
representation, condition or warranty except this Limited Warranty.
2. This Limited Warranty is made only to the original purchaser that purchased the Product directly from Medtronic, its aliates, its authorized
distributor, or its authorized representative. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT
NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE,
COMMON LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED
IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.
3. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of
applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conict with applicable law by a court of
competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be aected, and all rights and obligations shall be
construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the
purchaser specic legal rights.
Symbols
Catalog Number
Date of Manufacture
Lot Number
U.S. Federal law restricts this device to sales by or on the order of a licensed medical practitioner
3
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826 Coal Creek Circle
Lousville, CO USA 80027
www.stealthstation.com
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2013-03
© 2013 Medtronic, Inc.
EC REP
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The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Tracer®. All other trademarks, service
marks, registered trademarks, or registered service marks are the property of their respective owners in the United States and other countries.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described
in this manual without notice and without incorporating those changes to products already sold. Released documents are available to view or print at
manuals.medtronic.com.
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