SURGICAL TECHNIQUE MANUAL

3

TABLE OF CONTENTS

TABLE OF CONTENTS

System Values and Mechanism of Action 4

Indications and Contraindications 5

Implant 6

Instrument Set 7

Instrument Assembly 8

Precautions 10

Pre-operative Planning 11

Surgical Procedure 12

Potential Adverse Events 30

MRI Information 31

Reusable Instruments and Instrument Tray Cleaning 32

and Sterilization Instructions

Caution: Not for distribution in the United States

4

SYSTEM VALUES AND MECHANISM OF ACTION

SYSTEM VALUES

MECHANISM OF ACTION

– Typical 15 minute implantation time 1

– Reduced overall procedure time compared with pedicle screw based fi xation systems 1,2

– One size: Novel adjustable band locking mechanism allows adjustment to patient size and anatomy– Band fi xation results in less procedural morbidity compared to pedicle screw fi xation 1,3,4

– The LimiFlex™ Paraspinous Tension Band is designed to work in parallel with ligaments and facets, and utilizes low forces to minimize loads on the anatomy 5

– The LimiFlex™ Paraspinous Tension Band maintains sagittal lordosis while preventing progressive slip and translation 1

The LimiFlex™ Paraspinous Tension Band restores the range of motion of a destabilized segment and increases segmental stiffness, as demonstrated in biomechanical testing. Limiting flexion has a corresponding effect on translational instability. 5

1 Simpirica Spine post-market clinical studies.Data on fi le / 2 Weinstein JN et al. N Engl J Med 2007;356:2257–70 / 3 Yuan HA et al. Spine 1994;19(20S):2279S–96S4 Deyo RA et al. JAMA 2010;303:1359–65 / 5 Fielding et al. Eur Spine J 2013; DOI 10.1007/s00586-013-2934-y

Sta

ndin

g Po

stur

eFl

exed

Pos

ture

5

INDICATIONS AND CONTRAINDICATIONS

INDICATIONS FOR USE

CONTRAINDICATIONS

The LimiFlex™ Paraspinous Tension Band indications for use are:– Symptomatic spinal instability following spontaneous or iatrogenic disc degeneration– Spinal stenosis (to prevent instability which may be induced by surgery)– Multi-operated and instability adjacent to a stiff segment– Degenerative spondylolisthesis without lysis

The LimiFlex™ Instruments are intended to facilitate the implantation of the LimiFlex™ Device

The LimiFlex™ Instrument Tray is intended to:– organize and protect the LimiFlex™ Instruments during transportation, storage, and sterilization– allow sterilization of the LimiFlex™ Instruments by prevacuum steam sterilization using the provided validated parameters (see pages 32–34)

The LimiFlex™ Device should not be used in the following situations:– Allergy to or intolerance of titanium or polyethylene– Absence of spinous process(es) of the segments to be instrumented– Facet incompetence – A primary and predominant diagnosis of facet-mediated back pain– Bilateral isthmic spondylolysis of segments to be instrumented– Posterior element tumor – Spinous process fracture(s) or other posterior element fracture(s) of the segment to be instrumented – Estimated distance between the LimiFlex™ Device band attachment points (midpoint of the cranial edge of the cranial spinous process and midpoint of the caudal edge of the caudal spinous process) is <30mm on pre-operative lateral standing radiographs at the segment to be instrumented– Active systemic or local infection or infection of vertebral bodies Attachment of a single LimiFlex™ Device to two non-adjacent spinous processes– Severe osteoporosis or other systemic or local conditions that may prevent adequate fi xation– Severe muscular, neural, or vascular diseases that endanger the spinal column– Pregnancy

6

IMPLANT

OVERVIEW: IMPLANT AND INSTRUMENT SET

KLF-3001: LimiFlex™ Paraspinous Tension BandOne (1) LimiFlex™ Device consists of two (2) dynamic titanium rods each with a roller screw and a pre-attached utra high molecular weight (UHMW) polyethylene textile band. The LimiFlex™ Device is packaged sterile with two (2) Leaders (accessory) designed to facilitate placement of the bands around the spinous processes.

ROLLER SCREW

DYNAMIC TITANIUM ROD

BAND LEADER

7

INSTRUMENT SET

LI-: HOLDER (X) LI-: BAND PASSER LI-: BAND TENSIONER

LI-: TENSIONER CLIP (X) LI-: SYMBOL PLATE LI-: LOCKI NG DRIVER

KLI-3002: LimiFlex™ Instrument Set

8

INSTRUMENT ASSEMBLY

BAND PASSER ASSEMBLYHOLDER ASSEMBLY

1 Slide flange of sleeve into knob.

3 Rotate knob counter-clockwise to engage with shaft.

2 Slide shaft through knob into sleeve.

Reverse assembly steps to disassemble Band Passer.Reverse assembly steps to disassemble Holder.

1 Slide flange of knob into outer cannula.

3 Tighten knob clockwise several turns to engageinner cannula.

2 Slide inner cannula into outer cannula, rotating inner cannula to align flat with keying feature.

9

INSTRUMENT ASSEMBLY

LOADING INSTRUMENTS INTO INSTRUMENT TRAY

1 Ensure all instruments are disassembled.

2 Load instrument components into instrument tray base as shown below, using graphics in tray for correct placement.

3 Place instrument tray lid onto instrument tray base. Close both latches and ensure lid is securely attached.

LI-: HOLDER (X)

LI-: BAND TENSIONER

LI-: LOCKING DRIVER

LI-: BAND PASSER

LI-: TENSIONER CLIP (X)

LI-: SYMBOL PLATE

10

PRECAUTIONS

PRECAUTIONS

It is important to read the Instructions for Use (IFU) prior to use of the LimiFlex™ Paraspinous Tension Band. The surgical procedure described in this Surgical Technique Manual is supplementary to and is adapted from the steps provided in the IFU

Preoperative planning and familiarity with the LimiFlex™ surgical technique are essential. Do not use this product if you have not been properly trained in its use.

Do not re-use / Do not resterilize. Reuse, reprocessing or re-sterilization of the device may compromise the structural integrity of the device and / or create a risk of contamination of the device, which could result in patient injury, illness, or death.

The LimiFlex™ Device and Leaders are sterilized with ethylene oxide. They are provided sterile unless the package is opened or damaged. Inspect the LimiFlex™ Device, Leaders and packaging before use to verify that no damage has occurred to the sterile packaging and that all product remains properly positioned in the packaging.

The LimiFlex™ Instruments and LimiFlex™ Instrument Tray are reusable and must be cleaned and sterilized prior to each use in accordance with the cleaning and sterilization instructions (see pages 32-34).Do not alter the pre-assembled device, accessory, or instruments prior to use of the devices.

Throughout the entire procedure, do not engage the Locking Driver with the LimiFlex™ Device unless both rods are loaded onto Holders and the Symbol Plate is in place on top of Holders. Do not engage the Locking Driver with the LimiFlex™ Device before the procedure: doing so could impede proper implantation. The LimiFlex™ Device is provided pre-aligned in its packaging to facilitate the threading of the tips of the bands through the attachment mechanisms of the rods.

The device must be appropriately adjusted for the individual patient, taking anatomical and biomechanical factors into account.

The LimiFlex™ Device should be implanted only while using radiographic visualization; imaging should be utilized during implantation to ensure titanium rods are appropriately positioned and tensioned. Use the LimiFlex™ Instruments and Leaders (accessory) to implant the LimiFlex™ Device.

The use of one or more LimiFlex™ Device(s) to treat multiple segments in the same patient has not been studied.

Do not use a single LimiFlex™ Device to treat multiple segments or attach a single LimiFlex™ Device to two non-adjacent spinous processes.

Note:For additional information and a complete list of indications, contraindications, procedure steps, warnings, precautions, cautions, potential adverse events, and directions for use, please see the LimiFlex™ Paraspinous Tension Band Instructions for Use.

11

PRE-OPERATIVE PLANNING

PRE-OPERATIVE PLANNING

DecompressionIf decompression is performed, ensure a thorough, adequate decompression. (LimiFlex™ provides segmental stabilization, but does not provide mechanical decompression.)

Patient Position for LimiFlex™ ImplantationThe patient should be in a neutral or slightly extended position (approximating a standing posture) for optimal device tensioning.

If decompression is performed in a fl exed position, the patient will need to be re-positioned prior to tensioning the LimiFlex™.

LigamentsThe interspinous and supraspinous ligaments (ISL/SSL) at the implantation level may be resected and LimiFlex™ will still provide biomechanical stability. If possible, leave the ISL/SSL at the adjacent segments intact.

FacetsFacet incompetence is contraindicated because the LimiFlex™ Device requires facets that can resist shear loads.

Partial, undercutting facetectomy and foraminotomy may be performed. Ensure that the articular surface of the facet is preserved.

Spinous ProcessesManually confi rm the competence of the spinous processes after decompression, prior to implantation.

Up to ½ of each spinous process (cranial-caudal) may be resected.

Bone QualityLimiFlex™ may be implanted in patients with osteopenia or osteoporosis, however LimiFlex™ should not be used in patients with severe osteoporosis (T-score ≤ –2.5 with fragility fracture1).

1 Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group. World Health Organ Tech Rep Ser. 1994;843:1–129.

12

SURGICAL PROCEDURE

INCISION, DECOMPRESSION, AND PATIENT POSITIONING

Midline incision with bilateral fascial incisionsCreate a midline longitudinal incision at the affected level, followed by parallel bilateral fascial incisionsadjacent to the supraspinous ligament. Elevate the paraspinal musculature off of the spinous processesand laminae bilaterally. After decompression, if performed, reposition the patient if necessary to create the appropriate segmental alignment.

Decompression Decompression may be performed per standard technique (e.g., bilateral/midline-sparing, unilateral, midline, etc.).

Patient positioning After decompression, if performed, reposition the patient if necessary to create the appropriate segmental alignment.

Note: Manually confirm the competence of the spinous processes and facets after decompression, prior to implantation. Up to ½ of each spinous process (cranial-caudal) may be resected.

13

SURGICAL PROCEDURE

LOAD RODS ONTO HOLDERS

Load rodsInsert green face of the roller screw into the Holder.

Tighten knob Press the implant into the Holder.

Take care to avoid pinching gloves in the rod/Holder interface.

Tighten the knob by turning clockwise.Ensure that the Holder is clamped fl ush onto the rod.

Check band orientation Check that the band is against the fl at side of the Holder arm.

14

SURGICAL PROCEDURE

LOAD LEADER ONTO BAND PASSER

Load LeaderThe Leader fi ts into the Band Passer in only one orientation.

Tighten knob Rotate the knob clockwise to secure the Leader to the Band Passer.

Check band orientation The Leader curves clockwise to facilitate passing the band around the spinous processes.

Ensure Leader is secure.

15

SURGICAL PROCEDURE

PASS FIRST BAND AROUND SPINOUS PROCESS

Position LeaderThe Leaders are used to pass the bands around the spinous processes in the clockwise direction.Use the Leader to locate the edge of the spinous process.

Pierce the anterior half of the interspinous ligament as close to the spinous process as possible.

Ensure the band is not twisted. The beveled edge faces up.

Pierce ligamentRotate the T-handle 90° clockwise while pressing the Leader against the interspinous ligament to pierce the interspinous ligament.

Retrieve Leader with clamps Use needle-holder clamps to fi rmly grasp the Leader on the contra-lateral side of the interspinous ligament.Turn knob counter-clockwise to release Leader from Band Passer.

Pull distal end of Band Passer laterally to disengage from Leader.

Pull Leader and band through ligament with clamps.

16

SURGICAL PROCEDURE

PASS SECOND BAND AND CONFIRM LEVEL

Pass second bandPass the second band using the Band Passer and the same technique as for the fi rst band.

Check that both bands are against the spinous processes.

Verify correct level and that band is not twistedVerify that bands are at the correct level, around the correct spinous processes (fl uoroscopy recommended).

Verify that the bands are not twisted and that the beveled edges face dorsally.

Remove Leaders Remove Leaders from the ends of the bands.

17

SURGICAL PROCEDURE

Thread bands through rodsInsert the tip of the band on the left side through the slot in the locking mechanism of the rod on the left side.

Insert the tip of the band on the right side through the slot in the locking mechanism of the rod on the right side.

Ensure the bands are not twisted and the beveled edge is oriented dorsally.

Remove slack from bands Manually remove slack from the bands as the rods are placed into the incision.

THREAD BANDS THROUGH RODS

18

SURGICAL PROCEDURE

CONNECT HOLDERS AND PREPARE TO LOCK FIRST BAND

Place rodsPlace rods medial to the paraspinal musculature. Ensure rods are flush against the spinous processes.

Mate HoldersConnect Holders. Remove slack from both bands by pulling on the end of each band.

Place Symbol PlatePlace Symbol Plate onto top of Holders so that Holder knobs extend through holes in Symbol Plate.

Insert Locking DriverInsert Locking Driver into first Holder cannula with the flag in the unlock zone on the Symbol Plate. A tactile and audible “click” will be felt and heard when the Locking Driver correctly mates with implant.

19

SURGICAL PROCEDURE

LOCK FIRST BAND

Lock bandSecure and lock band by turning Locking Driver handle clockwise until the lock symbol on the Symbol Plate is completely visible within the window of the Locking Driver flag.

Caution:– Do not overtighten Locking Driver while securing first band. Overtightening could make later re-adjustment difficult.– After Locking Driver is turned clockwise until the lock symbol on the Symbol Plate is completely visible within the window of the Driver flag, to ensure the device is properly locked, the flag window must remain entirely within lock zone.

Note: Confirm that band is securely locked before proceeding to next step.

20

SURGICAL PROCEDURE

REMINDER: CHECK PATIENT POSITION

Note: Prior to tensioning LimiFlex™, confirm that the patient positioning is correct.

The patient should be in a neutral or slightly extended position (approximating a standing posture) for optimal device tensioning.

If decompression is performed in a flexed position, the patient will need to be re-positioned prior to tensioning the LimiFlex™.

The icon on the top of the Driver provides a reminder to check patient position and alignment.

21

SURGICAL PROCEDURE

PLACE TENSIONER CLIP AND BAND TENSIONER

Attach Tensioner ClipAttach circular end of Tensioner Clip to Holder.

Ensure that Tensioner Clip is moved all the way up under the Holder head and Symbol Plate.

Position Band TensionerThread Band Tensioner onto second band and slide into incision until distal end is next to rod.

Ensure that band is not twisted and that beveled edge faces dorsally.

Mate ball of Band Tensioner with Tensioner Clip

22

SURGICAL PROCEDURE

TENSION DEVICE

Tension ImplantRotate Band Tensioner clockwise until both rods extend to Holder arms.

While tensioning, check that the rods are even and that the device is centered at the target level.

Tensioning is controlled:– Over-tensioning is prevented by the Holder arms– Under-tensioning is seen as a gap between the Holder arms and the rods (lateral fl uoroscopy image recommended to verify implant tension)

Tensioned

Untensioned

23

SURGICAL PROCEDURE

LOCK SECOND BAND

Insert Locking DriverInsert Locking Driver into cannula of second Holder with flag in the unlock zone on the Symbol PlateA tactile and audible “click” will be felt and heard when the Locking Driver correctly mates with the implant.

Caution: After Locking Driver is turned clockwise until the lock symbol on the Symbol Plate is completely visible within the window of the Driver fl ag, to ensure the device is properly locked, the fl ag window must remain entirely within the lock zone. Confi rm that fl ag window remains entirely within the lock zone.

Lock BandSecure and lock band by turning Locking Driver handle clockwise until the lock symbol on the Symbol Plate is completely visible within the window of the Locking Driver flag.

Confirm that flag window remains entirely within the lock zone.

24

SURGICAL PROCEDURE

CONFIRM TENSIONING AND THAT NERVE ROOTS ARE FREE

Check: – Rods extended to touch Holder arms– Device centered on interspinous interval– Segmental extension / lordosis correct

Check: – Nerve roots free (lateral recess, foramen, etc.), e.g. with a probe

Check device tension and positioning

Confi rm tensioning with fl uoroscopyOn a lateral fluoroscopic image it can be confirmed that rods are tensioned:Rods extend to Holder arms and gaps between rods and Holder arms are closed.

Confi rm nerve roots are free

25

SURGICAL PROCEDURE

READJUSTMENT & UNLOCKING THE BAND (IF REQUIRED)

Unlock bandTurn Locking Driver counter-clockwise until flag is in unlock zone on Symbol Plate.

If both sides require re-adjustment, repeat this step for the second side.

Repeat procedure starting from page 19 with locking of first band in order to tension, secure, and lock bands.

Note: The band is only to be unlocked if readjustment of the LimiFlex™ Device is desired, for example if the patient positioning or device cranial-caudal location is unsatisfactory.

Caution: If the Holders have already been removed prior to re-adjustment, do not engage the Locking Driver alone with the LimiFlex™ Device. Instead, ensure that both rods are loaded onto Holders and that Symbol Plate is in place on top of Holders prior to re-adjustment.

If re-adjustment is deemed necessary after Holder removal, re-apply Holders and Symbol Plate, re-insert Locking Driver into same position in which it was prior to removal, and proceed to appropriate steps to re-adjust.

If Holders cannot be re-applied for re-adjustment, cut bands if necessary, remove both rods and bands, and use another LimiFlex™ Device.

26

SURGICAL PROCEDURE

FINAL CHECK BEFORE INSTRUMENT REMOVALFINAL CHECK BEFORE INSTRUMENT REMOVAL

1. LordosisCheck: Treated segmental angle similar to that of a neutral to slightly extended position.

3. Nerve roots freeCheck: Lateral foramina open.

Check: Nerve roots free after tensioning.

2. TensionCheck: Rods both extended to the ends of the Holder arms.

Check: Bands routing along flat, medial sides of Holder arms.

27

SURGICAL PROCEDURE

REMOVE INSTRUMENTS

Remove Locking DriverLift Locking Driver straight out of Holder.

Do not turn Locking Driver as it is removed.

Remove Symbol PlateLift Symbol Plate off Holders.

Remove HoldersTurn knobs counter-clockwise (approximately 6 turns) to release Holders from rods.

Gently shake Holders to release from implant.

Manually inspect device in situ to confi rm band tension and position.

Remove any other remaining instruments from incision.

28

SURGICAL PROCEDURE

VERIFY TENSION AND POSITION

Take fl uoroscopic imagesFinal AP and lateral fluoroscopic images should be taken to verify device tension and position.

Cut bandsCut excess bands on both sides using a sharp scalpel. Leave 10 - 20 mm of band on each side of implant.

Discard the excess bands and Leaders.

29

SURGICAL PROCEDURE

FINAL RESULT

On an AP fl uoroscopic image, rods may be seen conforming to the anatomy and the ends may curve slightly medially along the spinous processes when under tension. This is normal.

Close incision using standard technique

30

POTENTIAL ADVERSE EVENTS

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with use of the LimiFlex™ Device include:

– Patient injury or lack of device functioning due to: Dislocation or loosening of the device after surgery Malpositioning of the device Malalignment of anatomical structures Mechanical failure of the device (device breakage, device separation or disassembly)

– Infection

– Chronic infl ammation (foreign body reaction, bursitis) related to the device

– Allergic reaction

– Unsatisfactory clinical results that may include but are not limited to increased pain at the implant level and exacerbation of symptoms

– Fracture and/or erosion of the spinous processes

– Spontaneous fusion due to heterotopic ossifi cation, development of bridging bone or osteophytes

– Nerve and/or vascular damage

– Additional surgery due to device readjustment or removal

These adverse events do not include all adverse events which could occur with surgery in general but are important considerations particular to implantable internal fi xation devices.

For additional information and a complete list of indications, contraindications, warnings, precautions, cautions, and potential adverse events, please see the LimiFlex™ Paraspinous Tension Band Instructions for Use.

31

MRI INFORMATION

MRI INFORMATION

MR Conditional (Contact Simpirica Spine for additional information)

The LimiFlex™ Device was determined to be MR-conditional in non-clinical testing. A patient with this device can be scanned safely, immediately after placement under the following conditions:

Static Magnetic Field Static magnetic field of 3-Tesla or less Highest spatial gradient magnetic field of 720-Gauss/cm or less

MRI-Related Heating In non-clinical testing, the LimiFlex™ Paraspinous Tension Band produced the following temperature rises during MRI performed for 15-min of scanning (i.e., per pulse sequence):

1.5-Tesla/64-MHz 3-T/128-MHz

MR system reported, whole body averaged SAR

2.9-W/kg 2.9-W/kg

Calorimetry measured values, whole body averaged SAR

2.1-W/kg 2.7-W/kg

Highest temperature change 1.8° C 2.2° C

Artifact Information MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the LimiFlex™ Paraspinous Tension Band. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 10-mm relative to the size and shape of this implant.

32

REUSABLE INSTRUMENTS AND INSTRUMENT TRAY CLEANING AND STERILIZATION INSTRUCTIONS

The LimiFlex™ Instruments and LimiFlex™ Instrument Tray are reusable and must be cleaned prior to being sterilized. The instruments and tray should be completely disassembled, rinsed and placed into an enzymatic detergent solution following use. The following cleaning processes have been validated for the instruments and tray.

Manual Cleaning Before Sterilization– Completely disassemble the Holder and Band Passer instruments as described above. These instruments are to remain disassembled throughout reprocessing.

– Thoroughly rinse all components under lukewarm tap water for a minimum of one (1) minute.

– Soak all components in an enzymatic detergent solution such as Enzol or equivalent for at least fi ve (5) minutes. When preparing baths of cleaning solutions, follow the manufacturer’s instructions.

– Remove visible debris and thoroughly clean the instrument and tray components with a soft bristle brush. Flush small spaces and lumens with a syringe and tube brush. Perform the brushing while fully submerged in the enzymatic cleaning solution. Pay close attention to latches, hard to reach areas, textured surfaces, or crevices. Open and close tray latches during cleaning to free trapped blood and debris.

– Rinse the components in tap water for a minimum of one (1) minute. Use a syringe to fl ush small spaces and lumens. Pay close attention to latches, hard to reach areas, textured surfaces, or crevices. Open and close tray latches while rinsing.

– Prepare a new unused bath of enzymatic detergent solution. Fully immerse the components in the prepared cleaning solution. Thoroughly brush the components assuring all hard-to-reach areas are accessed. Use a tube brush and syringe to aid in cleaning of lumens or hard-to-reach areas. Pay close attention to latches, hard to reach areas, textured surfaces, or crevices. Open and close tray latches during cleaning to free trapped blood and debris. Assure all visible contamination is removed.

– Thoroughly rinse the components under running lukewarm tap water for a minimum of one (1) minute. Use a syringe to fl ush lumens and other hard-to-reach areas. Pay close attention to latches, hard to reach areas, textured surfaces, or crevices. Open and close tray latches while rinsing.

– Dry the components with a clean soft cloth. Filtered, pressurized air may also be used.

– Inspect the components for any residual contamination. If contamination is seen, repeat the cleaning process.

– Verify the instruments and tray are in good working order.

– Check that all instruments and tray components are completely dry and that all deposits of mineral substances from cleaning have been removed before the autoclave sterilization cycle.

CLEANING AND STERILIZATION INSTRUCTIONS REUSABLE INSTRUMENTS AND INSTRUMENT TRAY

33

REUSABLE INSTRUMENTS AND INSTRUMENT TRAY CLEANING AND STERILIZATION INSTRUCTIONS

Cleaning with an Automated Washer/Disinfector Before Sterilization Prior to automatic washing, the instruments and tray must be pre-washed to remove debris:

– Completely disassemble the Holder and Band Passer instruments as described above. These instruments are to remain disassembled throughout reprocessing.

– Thoroughly rinse all components under lukewarm tap water for a minimum of one (1) minute.

– Soak all components in an enzymatic cleaning solution such as Enzol or equivalent for at least fi ve (5) minutes. When preparing baths of cleaning solutions, follow the manufacturer’s instructions.

– Remove visible debris and thoroughly clean the instrument and tray components with a soft bristle brush. Flush small spaces and lumens with a syringe and tube brush. Perform the brushing while fully submerged in the enzymatic cleaning solution. Pay close attention to latches, hard to reach areas, textured surfaces, or crevices. Open and close tray latches during cleaning to free trapped blood and debris.

– Thoroughly rinse the components under running lukewarm tap water for a minimum of one (1) minute. Use a syringe to fl ush small spaces and lumens. Pay close attention to latches, hard to reach areas, textured surfaces, or crevices. Open and close tray latches while rinsing.

Adhere to the instructions provided by the manufacturer for the specifi c washer/disinfector to be used. Place all components into the automatic washer such that cannulations and holes can drain. Take care not to overload wash baskets.

The following parameters are recommended by Simpirica Spine based on validation tests for reprocessing the LimiFlex™ Instruments and LimiFlex™ Instrument Tray with an automated washer/disinfector:

– 2 minute prewash with cold tap water– 20 second enzyme spray with hot tap water– 1 minute enzyme soak– 15 second cold tap water rinse (2x)– 2 minute detergent wash with tap water heated at 66°C / 150°F– 15 second hot tap water rinse– 1 minute thermal rinse with hot tap water heated at 82°C / 180°F– 10 second rinse with pure water heated at 66°C / 150°F– 7 minutes hot air dry at 115°C / 239°F

Inspect the components for any residual contamination. If contamination is seen, repeat the cleaning process. Verify the instruments and tray are in good working order. Check that all components are completely dry and that all deposits of mineral substances from cleaning have been removed before the autoclave sterilization cycle.

34

REUSABLE INSTRUMENTS AND INSTRUMENT TRAY CLEANING AND STERILIZATION INSTRUCTIONS

WARNINGS: – Completely disassemble the Holder and Band Passer instruments as described above prior to cleaning.

– Neutral pH agents are recommended for use with the LimiFlex™ Instruments and LimiFlex™ Instrument Tray. Alkaline agents with pH of 12 or less may be used where required. Note that alkaline agents may cause cosmetic blemishes such as discoloration of plastic components or faded markings. Ensure that all markings are legible prior to use.

– Avoid all abrasive products or cleaning tools, such as strong mineral acids (sulphuric, nitric, hydrochloric, etc.), strong Lewis acids such as zinc chlorite or sodium hypo chlorite, soda or any high hypochlorite or permanganate ion concentrations, and most aggressive solvents such as ethylene dichlorite, phenolic and aniline solutions.

– Avoid prolonged exposure to high temperatures.

Sterilization: The LimiFlex™ Instruments must be sterilized prior to use. Load the instruments into the instrument tray as described above. The following steam sterilization parameters have been validated to provide a sterility assurance level of 10-6 for the LimiFlex™ Instrument Set using a sterilization container system:

Method Cycle Temperature Exposure Time Min. Dry Time

Steam Pre-vacuum 132°C ± 2°C 4 minutes ± 10sec 30 minutes

WARNINGS: – Completely disassemble the Holder and Band Passer instruments as described above prior to sterilization. – Use the provided instrument tray.

– Do not use any other sterilization method.

– Do not use damaged or worn instruments. Inspect the LimiFlex™ Instrument Set for corrosion or wear that would hamper function of the instruments or instrument tray prior to use.

35

SIMPIRICA SPINE, INC.1680 Bayport Ave.San Carlos, CA 94070 USA

Tel: +1 650-592-6300Fax: +1 650-362-1846www.simpirica.com

SIMPIRICA SPINE GMBHUniversitätsstraße 7150931 Köln, Germany

Tel: 0800 560 0953

LB-10108.001.A