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LCP Posterior Medial Proximal Tibial Plate 3.5. Part of the Synthes small fragment LCP system.
Surgical Technique
This publication is not intended for distribution in the USA.
Instruments and implants approved by the AO Foundation.
Image intensifier control
This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.
Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 1
Table of Contents
Introduction
Surgical Technique
Product Information
MRI Information 25
LCP Posterior Medial Proximal Tibial Plate 3.5 2
AO Principles 4
Indications and Contraindications 5
Preoperative Planning 6
Preparation 7
Approach– Posteromedial 8 – Posterior 10
Fracture Reduction and Screw Insertion 12
Alternative Technique for Screw Lengths up to 60 mm 18
Plates 20
Screws 21
Instruments 22
Sets 24
2 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
The LCP Posterior Medial Proximal Tibial Plate 3.5 is part of the Synthes small fragment LCP system that merges locking screw technology with conventional plating techniques.
The LCP Posterior Medial Proximal Tibial Plate 3.5 is available in stainless steel or titanium and has a limited-contact shaft profile. The head and neck portions of the plate accept lock-ing, conical and cortex screws B 3.5 mm or cancellous bone screws B 4.0 mm.
Screw divergenceThe two proximal screw holes have 10° divergent trajecto-ries, each diverging 5° from the plate midline.
LCP Posterior Medial Proximal Tibial Plate 3.5. Part of the Synthes small fragment LCP system.
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 3
Features – Plate tapers from 3.4 mm to 1.9 mm
thick – Available with 1, 2, 4, 6, 8 or
10 holes in the plate shaft – Available in implant- quality 316 L
stainless steel or titanium alloy TAN
Combi-holes allow locking or compression options
Option for rafting screws
Elongated combi-holes in the neck and shaft facilitate plate adjustment and allow locking or compression
Limited-contact surface reduces bone-to-plate contact and may help to preserve the periosteal blood supply
Low-profile head(1.9 mm thick)
4 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
AO Principles
1 Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991.
2 Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.
1
4
2
3
4_Priciples_03.pdf 1 05.07.12 12:08
4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique
AO PRINCIPLES
In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.
1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.
2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.
Anatomic reductionFracture reduction and fixation to restore anatomical relationships.
Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.
Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.
Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.
Stable fixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.
Anatomic reductionFracture reduction and fixation to restore anatomical relationships.
Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.
Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.
In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1,2.
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 5
IndicationsThe Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal and metaphyseal areas of the tibia.
ContraindicationsNo specific contraindications.
Indications and Contraindications
LCP Posterior Medial Proximal Tibial Plate 3.5
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For use only with the Original AO/ASIF System ofInstruments and Implants
0 10 20 30 40 50 60 70 80 90 100 mm
1.10 Magnification
Synthes GmbHEimattstrasse 3CH-4436 Oberdorfwww.synthes.com
Locking Screw 3.5 mm, self-tapping, Length X13.040 40 mmX13.045 45 mmX13.050 50 mmX13.055 55 mmX13.060 60 mmX13.065 65 mmX13.070 70 mmX13.075 75 mmX13.080 80 mmX13.085 85 mmv13.090 90 mm
Holes Length0X.120.701 1 69 mm0X.120.702 2 79 mm0X.120.704 4 105 mm0X.120.706 6 131 mm0X.120.708 8 157 mm0X.120.710 10 183 mm
X=2: Stainless SteelX=4: Titanium
Lateral view
AP view
6 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
Use the preoperative planning template for the LCP Posterior Medial Proximal Tibial Plate 3.5 (034.000.657).
Complete the radiographic assessment and prepare the preoperative plan. Determine plate length and instruments to be used.
Note: Determine proximal screw placement and screw lengths to ensure proper screw placement in the metaphysis.
Preoperative Planning
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 7
Sets
01.120.702 LCP Posterior Medial Proximal Tibial Plates 3.5 (Stainless Steel), in Modular Tray, Vario Case System
or01.120.703 LCP Posterior Medial Proximal Tibial Plates 3.5 (TAN), in Modular Tray, Vario Case System
01.122.013 Small Fragment Basic Instruments, in Modular Tray, Vario Case System
01.122.015 Screw Insertion Instruments 3.5/4.0, in Modular Tray, Vario Case System
Optional instruments
394.350 Large Distractor, complete
323.055 Centering Sleeve for Kirschner Wire B 1.6 mm, length 70 mm, for Nos. 323.027 and 323.054
312.648* LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
324.214* Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling (for use with 312.648)
319.090* Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm
* Required for inserting LCP and conical screws longer than 60 mm
Note: For information on fixation principles using conven-tional and locked plating techniques, please refer to the Synthes LCP Locking Compression Plate surgical technique (DSEM/TRM/0115/0278(1)).
Preparation
8 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
1Position patient
Position the patient on a radiolucent operating table.
Visualization of the proximal tibia under fluoroscopy in both the lateral and AP views is necessary.
If the patient’s hip is normal, position the patient supine, abduct and externally rotate the leg and put it in a figure of four position. A bump under the contralateral hip may help.
If the hip is stiff, position the patient in a lateral decubitus with the involved limb down.
2Make incision
With the knee in slight flexion, make a straight or slightly curved incision running from the medial epicondyle toward the posteromedial edge of the tibia. The incision can be ex-tended as needed both proximally and distally.
Approach – Posteromedial
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 9
3Identify and expose pes anserinus
After opening the fascia, identify and expose the pes anserinus.
4Access tibial plateau
Retract the pes anteriorly and the gastrocnemius posteriorly and distally. Identify the medial edge of the tibial plateau.
Identify the meniscus and incise the capsule between the meniscus and the edge of the tibial plateau, gaining access to the knee joint.
Precautions: – Instruments and screws may have sharp edges or moving
joints that may pinch or tear user’s glove or skin. – Handle devices with care and dispose worn bone cutting
instruments in an approved sharps container.
10 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
The posteromedial side can be approached without exposing and dissecting the neurovascular structures. The posterior approach allows repair of avulsion fractures of the posterior cruciate and tangential fractures of the proximal tibial head.
1Position patient
Position the patient prone on a radiolucent operating table.
Visualization of the proximal tibia under fluoroscopy in both the lateral and AP views is necessary.
2Make incision
Make a lazy S-shaped incision in the popliteal fossa.
The incision should extend about 8 cm proximally and dis-tally from the joint line.
3Open crural fascia
Open the crural fascia. Identify and save the short saphenous vein and the medial sural cutaneous nerve.
Approach – Posterior
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 11
4Retract semimembranosus muscle
Identify the semimembranosus muscle and retract it medially. The origin of the medial head of gastrocnemius becomes vis-ible.
5Expose
Identify the anterior edge of the gastrocnemius and retract the muscle laterally. The muscle will protect the important neurovascular bundle.
Option: Transection of the gastrocnemius close to its origin may allow easier retraction and protection of the neurovas-cular bundle.
The posteromedial capsule comes into view. It can be incised where necessary to expose the fracture lines.
Alternative technique
Alternatively, a Lobenhoffer approach may be used.3
3 Fakler JK, et al (2007). Optimizing the Management of Moore Type I Postero-Medial Split Fracture Dislocations of the Tibial Head: Description of the Lobenhoffer Approach. J Orthop Trauma 21(5):330-336
12 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
1Reduce fracture
Instruments
394.350 Large Distractor, complete
Kirschner Wires
Note: Before reduction, application of an external fixator or large distractor may facilitate visualization and reduction of the joint.
Reduce the fracture fragments and confirm reduction using fluoroscopy. Fragments may be reduced using independent Kirschner wires.
The locking screws do not provide interfragment or plate-to- bone compression; therefore, any desired compression must be achieved with conical screws B 3.5 mm in the plate or independent lag screws.
Note: To verify that independent lag screws will not interfere with plate placement, hold the plate to the bone.
Fracture Reduction and Screw Insertion
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 13
2Position plate
Instruments
310.250 Drill Bit B 2.5 mm, length 110/85 mm, 2-flute, for Quick Coupling
314.070 Screwdriver, hexagonal, small, B 2.5 mm, with Groove
314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm
319.010 Depth Gauge for Screws B 2.7 to 4.0 mm, measuring range up to 60 mm
323.360 Universal Drill Guide 3.5
Alternative instrument
319.090 Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm
Using anatomic landmarks and fluoroscopy, mount the plate on the bone.
Place the universal drill guide 3.5 into the nonlocking portion of an elongated plate hole. Use the 2.5 mm drill bit to drill into the bone.
The plate may be temporarily held in place by a cortex screw B 3.5 mm or cancellous bone screw B 4.0 mm.
Notes: – When used as a buttress plate, cortex screws placed
through the plate below the fragment can be used to assist with indirect reduction of the fragment. Placing a nonlocking screw in an elongated LCP hole below the fracture allows easy adjustment of plate positioning be-fore inserting screws into combi holes in the shaft or plate head.
– It is not recommended to drill through both cortices as the posteromedial position of the plate may direct the drill bit into the anterior soft tissues. The tibial tubercle is a suggested aiming point.
1
2
14 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
3Insert cortex screws
Instruments
310.250 Drill Bit B 2.5 mm, length 110/85 mm, 2-flute, for Quick Coupling
314.070 Screwdriver, hexagonal, small, B 2.5 mm, with Groove
314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm
319.010 Depth Gauge for Screws B 2.7 to 4.0 mm, measuring range up to 60 mm
323.360 Universal Drill Guide 3.5
Alternative instrument
319.090 Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm
Measure for screw length with the depth gauge. (1)
Insert a screw with a small hexagonal screwdriver manually or under power. Determine the final position of the plate be-fore tightening completely. (2)
Insert additional cortex screws in combi holes as necessary using the above technique.
For the neutral position within a combi hole, press the drill guide down in the nonthreaded portion of the hole. To ob-tain compression, place the drill guide at the end of the non-threaded hole away from the fracture. Do not apply down-ward pressure on the drill guide’s spring-loaded tip.
Note: All of the cortex or cancellous bone screws must be inserted before insertion of locking screws B 3.5 mm.
Fracture Reduction and Screw Insertion
1
2
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 15
4Insert locking screws
Instruments
310.284 LCP Drill Bit B 2.8 mm with Stop, length 165 mm, 2-flute, for Quick Coupling
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
314.116 Screwdriver Shaft Stardrive 3.5, T15, self-holding, for AO/ASIF Quick Coupling
311.431 Handle with Quick Coupling
319.010 Depth Gauge for Screws B 2.7 to 4.0 mm, measuring range up to 60 mm
511.770 Torque Limiter, 1.5 Nm, for Compact Air Drive and Power Drive
or511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling
Thread the LCP drill sleeve 3.5 into an appropriate locking hole.
Use the LCP drill bit B 2.8 mm to drill into the bone. (1)
Remove the LCP Drill Sleeve 3.5 and measure with the depth gauge. (2)
16 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
Insert the appropriate length locking screw using a Stardrive screwdriver.
Notes: – Ensure proper reduction before inserting the first locking
screw. Once the locking screws are inserted, further reduction is not possible without loosening the locking screws.
– Always use a torque limiting attachment when using power to insert locking screws. Final tightening should be performed by hand.
Note: If longer screws (65 mm – 95 mm) are used, alterna-tive instruments may be needed.
Alternative instruments
319.090 Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm
312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling (for use with 312.648)
Fracture Reduction and Screw Insertion
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 17
Insert additional locking screws as necessary.
1
2
18 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
1Screw placement verification with Kirschner wire
Instruments
292.160 Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Stainless Steel
310.284 LCP Drill Bit B 2.8 mm with Stop, length 165 mm, 2-flute, for Quick Coupling
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
323.055 Centering Sleeve for Kirschner Wire B 1.6 mm, length 70 mm, for Nos. 323.027 and 323.054
511.770 Torque Limiter, 1.5 Nm, for Compact Air Drive and Power Drive
or511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling
Attach a LCP drill sleeve 3.5 to the plate. Insert a centering sleeve for Kirschner wire B 1.6 mm into the LCP drill sleeve. (1)
Insert a 1.6 mm Kirschner wire through the centering sleeve and drill to the desired depth.
Verify Kirschner wire placement under image intensification to determine if final screw placement is acceptable. (2)
Note: The Kirschner wire position represents the final posi-tion of the locking screw. Confirm that the Kirschner wire does not enter or interfere with the joint or other screws.
Alternative Technique for Screw Lengths up to 60 mm
1
2
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 19
2Measure for screw length and insert screw
Instruments
314.070 Screwdriver, hexagonal, small, B 2.5 mm, with Groove
314.116 Screwdriver Shaft Stardrive 3.5, T15, self-holding, for AO/ASIF Quick Coupling
311.431 Handle with Quick Coupling
323.060 PHILOS Direct Measuring Device for Kirschner Wire B 1.6 mm
Measurement may be taken by sliding the tapered end of the direct measuring device over the Kirschner wire and down to the centering sleeve. (1)
Remove the direct measuring device, Kirschner wire and centering sleeve, leaving the LCP drill sleeve 3.5 in place.
Use the LCP drill bit B 2.8 mm to drill the near cortex. (2) Remove the LCP drill sleeve 3.5. Insert the appropriate length locking screw.
Insert additional locking screws as necessary.
Implant RemovalUnlock all screws from the plate, then remove the screws completely from the bone. This prevents simultaneous rota-tion of the plate when unlocking the last locking screw.
For details regarding implant removal refer to the surgical technique “Screw Extraction Set” DSEM/TRM/0614/0104.
20 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
Plates
LCP Posterior Medial Proximal Tibial Plate 3.5*
Stainless steel Titanium Shaft holes Length Alloy (TAN) (mm)
02.120.701 04.120.701 1 69
02.120.702 04.120.702 2 79
02.120.704 04.120.704 4 105
02.120.706 04.120.706 6 131
02.120.708 04.120.708 8 157
02.120.710 04.120.710 10 183
* Available non-sterile or sterile packed. Add “S” to catalog number to order sterile product.
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 21
Screw B 3.5 mm with Conical Head, self-tapping, fully threaded – Smooth conical head – Fully threaded shaft – Hexagonal or Stardrive recess – Self-tapping tip – Lengths: 40 mm – 95 mm
Titanium Alloy (TAN) Stainless Steel
412.367 - 412.381 212.367 - 212.381
412.317 - 412.331 212.317 - 212.331
Screws
Locking Screw B 3.5 mm, self-tapping – Threaded conical head – Fully threaded shaft – Hexagonal or Stardrive recess – Self-tapping tip – Lengths: 10 mm – 95 mm
Titanium Alloy (TAN) Stainless Steel
413.010 - 413.095 213.010 - 213.095
412.101 - 412.131 212.101 - 212.131
Screw B 3.5 mm with Conical Head, self-tapping, short thread – Smooth conical head – Partially threaded shaft – Hexagonal or Stardrive recess – Self-tapping tip – Lengths: 40 mm – 95 mm
Titanium Alloy (TAN) Stainless Steel
412.467 - 412.481 212.467 - 212.481
412.417 - 412.431 212.417 - 212.431
Cortex Screw B 3.5 mm, self-tapping, hexagonal recess – May be used in the DCU portion of the combi-holes – Used to compress the plate to the bone or create axial
compression – Self-tapping tip – Lengths: 10 mm – 110 mm
Titanium Pure (TiCP) Stainless Steel
404.810 - 409.910 204.810 - 209.910
22 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
Instruments
394.350 Large Distractor
323.055 Centering Sleeve for Kirschner Wire B 1.6 mm, length 70 mm, for Nos. 323.027 and 323.054
312.648* LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
324.214* Drill Bit B 2,8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling
319.090* Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm
310.250 Drill Bit B 2.5 mm, length 110/85 mm, 2-flute, for Quick Coupling
314.070 Screwdriver, hexagonal, small, B 2.5 mm, with Groove
314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm
319.010 Depth Gauge for Screws B 2.7 to 4.0 mm, measuring range up to 60 mm
323.360 Universal Drill Guide 3.5
* Required for inserting LCP and conical screws longer than 60 mm
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 23
310.284 LCP Drill Bit B 2.8 mm with Stop, length 165 mm, 2-flute, for Quick Coupling
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
314.116 Screwdriver Shaft Stardrive 3.5, T15, self-holding, for AO/ASIF Quick Coupling
311.431 Handle with Quick Coupling
511.770 Torque Limiter, 1.5 Nm, for Compact Air Drive and Power Drive or
511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling
292.160 Kirschner Wire B 1.6 mm with trocar tip, length 150 mm, Stainless Steel
323.055 Centering Sleeve for Kirschner Wire B 1.6 mm, length 70 mm, for Nos. 323.027 and 323.054
292.180 Kirschner Wire B 1.6 mm with trocar tip, length 280 mm, Stainless Steel
323.060 PHILOS Direct Measuring Device for Kirschner Wire B 1.6 mm
24 DePuy Synthes LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique
LCP Posterior Medial Proximal Tibial Plate Set 3.5 in Vario Case
01.120.702 LCP Posterior Medial Proximal Tibial Plates 3.5 – SSt
01.120.703 LCP Posterior Medial Proximal Tibial Plates 3.5 – TAN
68.120.702 Modular Tray for LCP Posterior Medial Proximal Tibial Plates 3.5, size 1/2, without Contents, Vario Case System
684.060 Lid for Modular Tray, size 1/2
689.513 Vario Case, Framing, size 1/2, height 45 mm
689.515 Vario Case, Framing, size 1/2, height 88 mm
689.516 Vario Case, Framing, size 1/2, height 126 mm
689.537 Lid (Stainless Steel), size 1/2, for Vario Case
68.120.703 Labelling Clip for LCP Posterior Medial Proximal Tibial Plate Set 3.5, System Vario Case
01.122.013 Small Fragment Basic Instruments, in Modular Tray, Vario Case System
684.060 Lid for Modular Tray, size 1/2
68.122.013 Modular Tray for Small Fragment Basic Instruments, size 1/2, without content, Vario Case System
01.122.015 Screw Insertion Instruments 3.5/4.0, in Modular Tray, Vario Case System
684.060 Lid for Modular Tray, size 1/2
68.122.015 Modular Tray for Screw Insertion 3.5/4.0, size 1/2, without content, Vario Case System
Sets
LCP Posterior Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 25
MRI Information
Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.
Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 6 minutes [1.5 T] and for 15 minutes [3 T]).
Precautions: The above mentioned test relies on non-clini-cal testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients under-
going MR scanning for perceived temperature and/or pain sensations.
– Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning proce-dures.
– Generally, it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.
– Using the ventilation system may further contribute to reduce temperature increase in the body.
0123
Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com
Not all products are currently available in all markets.
This publication is not intended for distribution in the USA.
All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©
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