SYNFRAME RL AND SYNFRAME - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... · SynFrame RL and SynFrame Surgical Technique DePuy Synthes 5 187.316 SynFrame

SURGICAL TECHNIQUE

Modular approach and retraction system

SYNFRAME RL AND SYNFRAME

Instruments and implants approved by the AO Foundation.This publication is not intended for distribution in the USA.

Modular approach and retraction Modular approach and retraction systemsystem

AND SYNFRAMEAND SYNFRAME

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

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

SynFrame RL and SynFrame Surgical Technique DePuy Synthes 1

Table of Contents

Introduction SynFrame RL and SynFrame 2

Set Overview 4

AO Spine Principles 6

Surgical Technique Mounting the Basic System 7

Mounting Soft Tissue Retractors/Muscle Retractors 13

Mounting Bone Levers 15

Mounting Rib Retractors 17

Mounting Light-transmitting Rod and Optics Holder 19

Removal 21

Product Information Sets 23

Bibliography 37

Alu SST

Alu SST

2 DePuy Synthes SynFrame RL and SynFrame Surgical Technique

Optimizing minimally invasive surgeryExposure in the depth of the operating field by – Distal expansion capability allows

surgeon to work through a small skin incision

– Enhanced illumination by means of the polyaxial holder for optics and endoscope

The SynFrame family is composed of several modules, allowing for either a lumbar or a cervical set up. In addi-tion to the Stainless Steel blades (SST), blades made out of radiolucent alumin-ium alloy (Alu) are also available. Semi-transparent bone levers made out of Titanium Alloy (TAV) complete the system.

SynFrame RL and SynFrameModular approach and retraction system

Stable operating field – System attached to both sides of

the operating table – Precise fixation of the retractors

Soft Tissue and Muscle Retractors

TAV SST

SST


Enhanced visibility – Unobstructed view of the operating

field: Modules can be positioned freely on the frame

– Comprehensive overview of the operating field

– Aluminium and titanium alloy components allow for improved fluoroscopic viewing in comparison to stainless steel components.

Broad range of applications – All retractors can be combined – Different lumbar approaches

(anterior, lateral, posterior) – Anterior cervical approach

Atraumatic retraction – Traction forces can be individually

adjusted – Exact and rapid fixation: Constant

traction to protect critical structures

Bone Levers Rib Retractors Holder for Optics

Light-transmitting Rod


Set Overview

187.310SynFrame Basic System in Vario Case

687.313Vario Case for SynFrame Basic System (Fixa-tion Components for OR Table), with Lid, without Contents

687.319Vario Case for SynFrame Basic System (Fixation Components for Ring),with Lid, without Contents

SynFrame Basic System


187.316SynFrame Soft Tissue Retractors in Vario Case

187.322SynFrame Bone Levers in Vario Case

187.325SynFrame Muscle Retractors in Vario Case

01.609.102Set SynFrame RL, lumbar

01.609.101Set SynFrame RL, cervical

SynFrame (Stainless Steel)

SynFrame RL (radiolucent)

Optional Retractors for SynFrame,without Vario Case

Optional Retractors for SynFrame RL, without Vario Case

coronalaxial

sagittal


Copyright © 2012 by AOSpine

The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability – Alignment – Biology – Function.1,2

FunctionPreservations and resto-ration of function to prevent disability

StabilityStabilization to achieve a specifi c therapeutic out-come

AlignmentBalancing the spine in three dimensions

BiologyEtiology, pathogenesis, neural protection, and tissue healing

AO Spine Principles

1 Aebi et al (1998)2 Aebi et al (2007)


Mounting the Basic System

SynFrame is a surgical approach and retraction system. It consists of a basic system (basic construction) and modules that are specially designed for the respective requirements and needs of various indications and/or approach techniques (eg. anterior lumbar approach for total disc replacement). For further details and indications please refer to the corre-sponding technique guides.

The illustrations for the assembly technique of the SynFrame basic system will be described with reference to a supine patient (anterior lumbar approach in this case).

In other patient positions, the SynFrame basic system is always constructed in the same sequence following the same principles. Assembly on the operating table and over the surgical approach needs to be adapted to the patient posi-tion.

Sterile assembly of SynFrameTo separate the sterile area from the unsterile area on the operating table, sterile cover tubing or a corresponding cover with special fenestrated drapes is recommended.

Since the insulated holding base (387.346) can be sterilized, it can also be used in the covered area (for example over the sterile cover).

Note: During assembly, check if the holding base is firmly affixed to the guide rails of the operating table and does not move. The clamping mechanism for the holding base can damage special cover materials (such as Goretex) in certain circumstances.


1Mount the holding base

Tightly screw an insulated holding base (387.346) to the guide rails, diagonally to each other.

Offset the insulated holding base to the side so that:a. The retaining ring B 300 mm (387.336) can be affixed

cranially and caudally between the holding base on the operating table (required space: at least 400 mm),

b. The retaining ring can be positioned laterally and cranially or caudally between the angled rods (387.344) held in the holding bases depending on the planned surgery,

c. The freedom of movement and the work area of the surgeon and assistants are not restricted.

If this construction is not possible due to the patient’s posi-tion, the approach or the design of the operating table, always assemble the basic system so that it, and the retain-ing ring in particular, is held securely.

Note: The SynFrame holding base for the operating table insulates the entire SynFrame system from the grounded operating table and meets safety standards IEC 60601-1 and 2-2, VDE 0750 part 2, and VDE 0753 for ground-free patient positioning. Ground-free patient positioning with the SynFrame is only guaranteed by the manufacturer when original SynFrame holding bases are used. Damaged holding bases or those with an expired product expiration date may not be used.


SynFrame 03

SynFrame 03

2

1

SynFrame 03


2Insert the guiding tubes into the holding base

Insert both guiding tubes (387.343) into the holding bases at the same height in relation to the positioned patient, and clamp them with the clamp (1).

The outer diameter of the bottom part of the guiding tube mates with the guide of the holding bases. The larger outer diameter of the top part of the guiding tube acts as a stop so that the tightening bar (2) of the guiding tube does not touch the metal parts of the operating table or the insulated parts of the holding base which would eliminate the effects of the insulation.

3Fix the angled rods in the guiding tubes

Insert the angled rods (387.344) into the guiding tubes on both sides of the operating table, and affix them approxi-mately 5–10 cm from the patient.

4Affix tube-to-tube clamps on the angled rods

Loosely insert the tube-to-tube clamps (387.353) onto the two angled rods.

SynFrame 08


Alternative

Mount the retaining ring with an extensionThe round retaining ring B 300 mm can be enlarged to form an oval retaining ring 400 mm long. Insert the extensions (387.338) over the guide pins onto the half rings on both sides, and tighten them with the large hexagonal screw-driver.

6Mount the connection rods on the retaining ring

Open the clamps of the two connecting rods (387.345). Insert the retaining ring into the two clamps, and screw on the clamps with the large hexagonal screwdriver so that the connecting rods can still freely slide on the retaining ring. The retaining ring can thereby be optimally adapted to the placement of the positioned patient.

5Mount retaining ring

The retaining ring (387.336) consists of the two half-rings (387.337). To mount the retaining ring, insert the two half-rings over the guide pins. Tighten the side set screws with the large hexagonal screwdriver (314.270).


SynFrame 16

SynFrame 02

12

21


7Affix the retaining ring over the patient

Insert the retaining ring with the connecting rods into the tube-to-tube clamps on both sides, and affix it over the op-erative field.

Move the retaining ring as close as possible to the operative field so that the distance between the instruments later placed on the retaining ring and the operative field is as small as possible. If necessary, lower the angled rods further into the guiding tube.

Adjust the optimum position, and tighten the tube-to-tube clamps (1) and screws in the clamps of the connecting rods (2). Check the stability of the connecting elements to prevent undesirable movement during surgery.

Precaution: Do not lean against the basic SynFrame system. This could overload the construction, move individual parts of the SynFrame, and displace soft tissue and/or blood ves-sels. When moving the patient, monitor the position of the instruments in situ to avoid potential harm or dislocation of soft tissue and/or vessels.

Alternative way to mount the basic systemThe sequence of the steps can also be varied as follows:1. First affix the connecting rods to the tube-to-tube clamps.2. Then insert the mounted retaining ring into the opening

of the connecting rods.

(see steps 5–7)

SynFrame 09


8Mount the clamp on the retaining ring

The clamps (387.347) serve as a holder for the different SynFrame instruments on the retaining ring. They are con-struction elements of the basic system.

Check if the clamp is completely open before snapping it on. Snap the clamp with the larger of the two slotted openings onto the retaining ring without tightening it. Make sure that the clamp is affixed from the outside since the holding force of the clamp is greatest there given its construction.


SynFrame 10

SynFrame 11

SynFrame 18

SynFrame 17

a b


Mounting Soft Tissue Retractors/Muscle Retractors

Soft tissue retractors are for retraction of soft tissues and blood vessels. Muscle retractors are for retraction of muscles of the sub cutaneous tissues and the skin.

1Insert the retractor in the guide rod

From the side, insert the selected retractor into the adjust-able clamp of the guide rod (387.358) and rotate it 90° in the retaining ring. This holds the retractor in the guide, but the retractor remains fully movable.

Soft tissue retractor Muscle retractor

2Position the retractor

Position the retractor in the operative site, and clamp the guide rod of the retractor in the smaller slotted opening of the clamp. Make sure that the clamp is completely opened. The retractor is freely moveable on the retaining ring in ev-ery plane as long as the clamp is not screwed tight.

After the retractor is definitively positioned, stably affix the clamp by screwing tight.

Precaution: The retractors can apply a relatively large force to the soft tissue and vessels. For this reason, loosen the re-tractors from time to time to prevent pressure necrosis.

Precaution: Always align the retractor directly with the di-rection of pull of the guide rod so that the entire width of the retractor serves as a seat for the soft tissue (a). The pointed edge of the retractor may never contact the soft tissue (b); this can cause pressure necrosis and cause burns if it unintentionally contacts the coagulation device.


3Enlarging the work area

Loosen the setscrew in the adjustable clamp of the guide rod with socket wrench 6.0 mm (388.140). The adjustable tip of the affixed retractor can then be pivoted on its axis, and the visible working area can be enlarged.

Precaution: If the socket wrench is used as a lever, there is a danger of too much force being transmitted to the retractor. This can damage the retracted structures (overstretching the vessels and soft tissue). It is therefore recommendable to guide the moveable retractor with your finger. The tension can be adjusted and distributed safely for soft tissue.

4Retraction

For retraction, release the clamps until the guide rod can be moved. Carefully pull the guide rod and the retractor until the desired retraction is achieved. Then screw the clamp tight in this position.

Mounting Soft Tissue Retractors/Muscle Retractors


Mounting Bone Levers

1Anchor the bone lever in the bone

Position and anchor the bone lever in the bone with the aid of a hammer.

Warning: Carefully insert the bone lever into the operative site and hammer it in under visual observation. The sharp tip can cause tissue damage.

For retracting soft tissue, blood vessels and muscular structures.

2Affix the bone lever to the holder

Enlarge the operative site by pulling back the bone lever, and hang the lever over the ball of the holder (387.356). Patient movement can be compensated by the ball joint and the flexible end of the holder.


3Clamp the bone lever holder in the clamp

Clamp the bone lever holder in the smaller slotted opening of the clamp. As long as the clamp is not screwed tight, the holder for the bone lever can still be freely moved.

4Retraction

Carefully pull the holder for the bone lever in the not-fully- tightened clamp together with the retractor until the desired retraction is achieved. Then screw the clamp tight in this position.

Mounting Bone Levers


Mounting Rib Retractors

1Position the rib retractor

Place the rib retractor into the desired position.

For retracting ribs for a thoracic approach.

2Clamp the rib retractor in the clamp

Clamp the rib retractor in the smaller slotted opening of the clamp. As long as the clamp is not screwed tight, the rib retractor can still be freely moved.


3Retraction

Carefully pull the rib retractor in the not-fully-tightened clamp until the desired retraction is achieved. Then screw the clamp tight in this position.

Mounting Rib Retractors

SynFrame 15


Mount the light-transmitting rod

The light-transmitting rod (387.362) is equipped with an ACM connection. Use the required adapter (Storz or Wolf) depending on the available fiber-optic cable system.

Following the same procedure as with the guide rods for retractors, clamp the light-transmitting rod in the small slotted opening of the clamp.

As with the guide rods, it is recommended to position the light-transmitting rod so that the working area is directly illuminated deep in the operative site without hindering sur-gery.

Stably fix the light-transmitting rod on the frame by tighten-ing the clamp.

Precaution: Together with the high-power light sources, temperatures can arise at the light-source end and instru-ment end of the light-transmitting rod that can cause burns. In addition, high- energy light can increase the tissue tem-perature. For this reason, avoid direct contact with tissue, and maintain a distance between the tissue and distal end of the rod of at least 10 mm when affixing the SynFrame light-transmitting rod. Do not place the light-transmitting rod on flammable objects such as textiles (surgical drapes). Never look into the end of the connected light-transmitting rod (blinding hazard).

Mounting Light-transmitting Rod and Optics Holder

SynFrame 15


Mount the optics holder

Tighten the set screw to affix the holder for optics (387.365) facing outward on the ring so that the operative field remains free. Fix the polyaxial mechanism of the optics holder in the desired position using the central adjusting screw.

The optics holder is designed for optics with a diameter of 4 mm or 10 mm.

Mounting Light-transmitting Rod and Optics Holder


Removal

Remove SynFrame

SynFrame is removed in reverse sequence. The entire construction (retaining ring and connecting rods) above the patient can be quickly removed from the operative area by completely screwing out from the clamp the locking screws of the tube-to-tube clamps (387.353) on the angled rods.


Using SynFrame with devices from other manufacturers

Precaution: If SynFrame is used with high-frequency or electromedical surgical equipment, make sure that this equipment does not contact the metal parts of the SynFrame. The SynFrame manufacturer refers to the guide-lines and instructions associated with the high-frequency or electromedical surgical device manufacturers but also recom-mends the use of insulating and grounding techniques.

Removal


Sets

SynFrame Basic System

187.310 SynFrame Basic System in Vario Case

687.313 Vario Case for SynFrame Basic System 1 (Fixation Components for OR Table), with Lid, without Contents

Content of 687.313

387.346 SynFrame Holding Base, insulated, 2 for OR Table, dark blue

387.343 SynFrame Guiding Tube, 2 for Angled Rod No. 387.344, for Basic System

387.344 SynFrame Angled Rod, 2 for Basic System

387.353 SynFrame Tube-to-Tube Clamp, 2 for Basic System

687.319 Vario Case for SynFrame Basic System 1 (Fixation Components for Ring), with Lid, without Contents

Content of 687.319

387.345 SynFrame Connecting Rod, 2 for Holding Rings Nos. 387.336 and 387.337, for Basic System

387.336 SynFrame Retaining Ring B 300 mm, 1 two-part, complete, for Basic System

387.347 SynFrame Clamp for Holding Ring 8 No. 387.336, dark blue

387.358 SynFrame Guide Rod 6 with adjustable clamp, for Soft Tissue and Muscle Retractors

314.270 Screwdriver, hexagonal, large, 1 B 3.5 mm, with Groove, length 245 mm

388.140 Socket Wrench 6.0 mm, 1 with straight handle


Optional for 187.310

387.337 SynFrame Half-Ring, for Holding Ring 1 No. 387.336, for Basic System

387.338 SynFrame Extension, 2 for Nos. 387.336 and 387.337

387.361 SynFrame Guide Rod 6 with adjustable clamp, with Snap-in Locking, for Soft Tissue and Muscle Retractors

387.362 SynFrame Light-transmitting Rod 1

387.365 Holder for Optics B 10.0 and 4.0 mm, 1 polyaxial, for SynFrame Basic System

Included in 387.362

387.398 Adapter type Storz, for No. 387.362 1

387.399 Adapter type Wolf, for No. 387.362 1

Sets


SynFrame RL

01.609.102 Set SynFrame RL, lumbar

Vario Case

68.609.102 Vario Case For SynFrame, radiolucent, lumbar, without C ontents 1

Bone Levers

03.609.816 SynFrame Bone Lever, semi-transparent, 2 width 8 mm, length 160 mm




387.356 Holder for SynFrame Bone Lever 6

Retractors

03.609.006 SynFrame Soft Tissue Retractor, 4 radiolucent, blunt, width 25 mm, length 60 mm, Aluminium







01.609.101 Set SynFrame RL, cervical

Vario Case

68.609.101 Vario Case for SynFrame, radiolucent, 1 cervical, with Lid, without Contents

387.333 SynFrame Extension, with Joint 1

387.334 SynFrame Extension, with Joint, 1 with Snap-in Locking

387.335 SynFrame Holding Ring B 240 mm, 1 two-part, complete

Bone Levers






Sets


Retractors

Blunt/slim






Blunt/normal







Small teeth/slim

03.609.404 SynFrame Soft Tissue Retractor, 2 radiolucent, small teeth, width 15 mm, length 40 mm, Aluminium





Small teeth/normal






Sets


Big teeth/slim

03.609.604 SynFrame Muscle Retractor, radiolucent, 2 width 15 mm, length 40 mm, Aluminium





Big teeth/normal







Optional for SynFrame RL

Lumbar retractors

Blunt/normal





Sets


Blunt/wide













Cervical retractors

Blunt/slim



Blunt/normal



Small teeth/slim



Small teeth/normal



Sets


Big teeth/slim



Big teeth/normal




SynFrame (Stainless Steel)

187.316 SynFrame Soft Tissue Retractors in Vario Case, Stainless Steel

Vario Case

687.316 Vario Case for SynFrame Soft Tissue 1 Retractors, Stainless Steel, with Lid, without Contents

Content of 187.316

387.391 SynFrame Soft Tissue Retractor, 4 width 23 mm, length 60 mm






Sets


Vario Case

687.322 Vario Case for SynFrame Bone Levers, 1 Stainless Steel, with Lid, without Contents

Content of 687.322


399.201 SynFrame Bone Lever, width 8 mm, 3 length 100 mm







187.322 SynFrame Bone Levers in Vario Case, Stainless Steel


187.325 SynFrame Muscle Retractors in Vario Case, Stainless Steel

Vario Case

687.325 Vario Case for SynFrame Muscle 1 Retractors, Stainless Steel, with Lid, without Contents

Content of 687.325

387.372 SynFrame Muscle Retractor, 2 width 23 mm, length 20 mm






Optional Rib Retractors for SynFrame (Stainless Steel)

387.451 SynFrame Rib Retractor, 2 width 30 mm, length 40 mm

387.452 SynFrame Rib Retractor, 2 width 40 mm, length 50 mm

Optional Muscle Retractors for SynFrame (Stainless Steel)



Optional Soft Tissue Retractor for SynFrame (Stainless Steel)


Sets


Aebi M, Thalgott JS, Webb JK (1998): AO ASIF Principles in Spine Surgery. Berlin: Springer.

Aebi M, Arlet V, Webb JK (2007): AOSpine Manual (2 vols), Stuttgart, New York: Thieme

Bibliography

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com 0123 ©

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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

http://www.depuysynthes.com/ifu

Documents

SYNFRAME RL AND SYNFRAME - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... · SynFrame RL and SynFrame Surgical Technique DePuy Synthes 5 187.316 SynFrame