METRx® MICROSCOPE 0381036E Rev. B
2016-10-26
IMPORTANT INFORMATION ON THE METRx® MICROSCOPE SYSTEM
DESCRIPTION
The METRx® Microscope System is composed of a microscope, camera, an integrated video system, a video monitor and
recorder, and various cannula, dilators, extension lenses, and associated instruments.
No warranties, express or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are
specifically excluded.
INDICATIONS
The METRx® Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical
procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the
METRx® Microscope and accessories are intended to aid the surgeon’s visualization of the surgical area and allow him/her to
perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression
of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other
examples of generic surgical use of the METRx® Microscope would be for use in the knee, ankle, shoulder, hand, wrist, and
temporomandibular joint (TMJ).
CONTRAINDICATIONS
The METRx® Microscope and accessories have no known contraindications intrinsic to the device. No part of the microscope
itself or its accessories should ever be used in a cutting or tearing action, i.e., never use the Microscope as an instrument. The
optical device or its extension lenses should not be used to provide access to the surgical field. The device should not be
inserted into body cavities, hollow organs, or natural body openings.
There are no other known risks associated with the use of the device outside of the normal and expected risks of surgery. The
microscope should not be used non-sterile or in the presence of an infectious disease process.
DIRECTIONS FOR USE
Specific instructions for use depend on patient considerations. Therefore, Medtronic cannot provide a surgical procedure
applicable to all situations. Any available surgical procedure brochure or manual for the METRx® System Microscope device
and accessories should be reviewed prior to use. The only critical directions for use are to insert the cannula or dilators and
position them in the surgical wound prior to insertion of the microscope extension lenses and inner field visualization of the
surgical site. Never use the microscope extension lenses to provide access or as a surgical instrument in the surgical field.
Once visualization assistance is obtained, the surgeon can complete the planned surgical procedure.
POTENTIAL ADVERSE EFFECTS
Risks possibly associated with the use of the METRx® Microscope and accessories are similar to those associated with any
surgery to the planned area of instrument use. The most frequently stated risks are bleeding, neurological damage, damage to
the surrounding soft tissue, and infection. Each of these risks has also been used to describe the risks associated with
conventional surgical intervention. Additional risks associated with the use of METRx® Microscope, other than those described
for spinal surgery in general, may be instrument malfunction, such as bending, fragmentation, loosening, and/or breakage
(whole or partial). Breakage of the tip in the patient may increase surgical time, since this instrument should not be implanted.
Also, the surgery may not be effective. Similar risks are associated with the system use in other parts of the body.
Additional risks are attendant to surgery and the use of anesthesia, etc., and are not directly related to the use of the
microscope and accessories. These include, but are not limited to, pneumonia, phlebitis, embolism, wound infection, and blood
loss with or without anemia.
WARNINGS AND PRECAUTIONS
A successful result is not always achieved in every surgical case. This fact is especially true in orthopaedic or neuro-surgery
cases where many extenuating circumstances may compromise the results.
In the event of technical complications, the surgical technique can be converted to an open procedure and the surgery
completed.
Preoperative and operating procedures, including knowledge of surgical techniques are important considerations in the
successful utilization of the system by the surgeon. Further, the proper selection of the patient and the compliance of the patient
will greatly affect the results.
In addition, the following should be considered:
1. This device is a delicate instrument. It should NOT be dropped, bent at a sharp angle, or exposed to any type of gamma
radiation. Tip fracture fragmentation and optic damage may result if the microscope is not handled carefully.
2. Additional microscopes and accessories should be available at the time of surgery in case of possible contamination due to
mishandling or removing the devices from the sterile field.
3. Components of the system should be thoroughly inspected during cleaning prior to surgery for possible damage.
4. Proper, secure component connections must be made to ensure proper functioning of the optical, irrigation, and aspiration
aspects of the device.
Caution – high temperature.
Typically, a light source is used in conjunction with the METRx® System. To reduce the risk of patient injury or damage to
materials that may come into contact with this illumination system, always ensure the heat shield is in place covering the metal
cable connectors. It is recommended that this illumination system not be used with light sources rated over 300 Watts or with
fiber optic light cables larger than 5mm. However, due to inherent differences in light and power output among light sources, we
recommend the connector be monitored for elevated temperatures. Use caution when touching the metal connectors when
disconnecting the light cable after use.
CLEANING PROCEDURE
Exterior cleaning of the microscope and camera head is essential prior to any sterilization procedure. The camera head should
be removed from the microscope prior to cleaning. To remove blood, organic matter, and irrigation solutions, all surfaces of the
microscope and camera head should be cleaned with a mild detergent and water. Rinse with distilled, demineralized, or
pyrogen-free water. Dry thoroughly. Without the removal of all contaminants from the surface, the sterilization medium will not
contact the surfaces.
Warning: do not use ultrasonic cleaner or abrasives during the cleaning process.
STERILIZATION:
The microscope, light cable, non-sterile instruments, and instruments which are re-usable are recommended to be steam
sterilized by the hospital using one of the following methods:
Some cameras (9560500, 9560501) are autoclavable following the same recommendations. If the products described in this
document are sterilized by the hospital in a tray or case, they must be sterilized in a tray or case provided by Medtronic.
Some accessories and instruments are supplied sterile and non-reusable. Sterile product will be clearly labeled as such on the
package label. The sterility of the product supplied sterile can only be assured if the packaging is intact.
Note: the following note applies to the process parameter identified with the * below: For use of this product and instruments
outside the US, some non-US health care authorities recommend sterilization according to these parameters so as to minimize
the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come into contact
with the central nervous system.
METHOD CYCLE TEMPERATURE EXPOSURE TIME
Steam Pre-Vacuum 270°F (132°C) 4 Minutes
Steam Gravity 250°F (121°C) 60 Minutes
Steam* Pre-Vacuum* 273°F (134°C)* 20 Minutes
Steam* Gravity* 273°F (134°C)* 20 Minutes*
The microscope, camera, and light cable can also be EtO sterilized. The following EtO cycle is recommended:
Preconditioning parameters: Sterilization parameters:
Temperature: 55 ± 2° C Ethylene Oxide Carrier: Oxyfume 2002
Relative Humidity: ≥ 35% Temperature: 55 ± 2° C
Vacuum: 21 ± 1 In Hg
(508-559mm Hg)
Preconditioning time: 1 Hour Pressure: 19 ± 1 PSIG
Relative Humidity: ≥ 35%
(2.25-2.39 bars)
Ethylene Oxide Concentration: 736 mg/L
Gas Exposure Time (Full Cycle): 4 Hours
Aeration: 11 Hours at 54°C
minimum
The microscope and camera should be thoroughly cleaned prior to sterilization.
The integrated video system, video monitor, and recorder are also reusable and supplied non-sterile. These components should
not be placed in the surgical field.
Caution: microscopes and camera cannot be steam autoclaved unless “autoclavable” is engraved on the microscope or camera
body. This method would otherwise permanently damage the optical components.
Caution: do not immerse or rinse instruments in cold water or any other liquid to accelerate cooling.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
MRI INFORMATION
Medtronic instruments are not intended to be used in the magnetic resonance (MR) environment. As such, Medtronic
instruments have not been evaluated for safety and compatibility in the MR environment. Therefore, the safety of the Medtronic
instruments in the MR environment is unknown.
FURTHER INFORMATION
If there is any doubt or uncertainty concerning the proper use of this instrument, contact Medtronic. Any available surgical
techniques will be provided at no charge.
© 2016 Medtronic Sofamor Danek, Inc. All rights reserved.
AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Do not re-use
Batch code
Manufacturer
Catalogue number
Non-sterile
For US audiences only
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
The device complies with European Directive MDD
93/42/EEC
The device complies with European Directive MDD
93/42/EEC
Sterilized using irradiation
Consult instructions for use at this website.
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