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HCS 4.5/6.5. The countersinkable compression screw. Instructions for Use

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Page 1: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

HCS 4.5/6.5. The countersinkablecompression screw.

Instructions for Use

Page 2: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip
Page 3: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

HCS 4.5/6.5 2

Indications 4

Surgical Technique for HCS 4.5 and 6.5* 5

Screw Extraction 15

Implants – HCS 4.5 16

Instruments – HCS 4.5 18

Implants – HCS 6.5 21

Instruments – HCS 6.5 23

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe instrument set. Instruction by a surgeon experienced in handling theseinstruments is highly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multipart instruments,please refer to: www.synthes.com/reprocessing

* illustrated using HCS 4.5

Page 4: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

2 Synthes HCS 4.5/6.5 Instructions for Use

Self-drilling and self-tapping tipShorter surgery due to simplified surgi-cal technique

CannulationFor minimally invasive technique andguided insertion

Reverse-cutting flutesFacilitate screw removal and preventpotential breaking of implant

Cutting flutesFacilitate countersinking of the screwhead

Identical pitch of head andshaft threadsFor controlled closure and compression of the fracture gap

Two different thread lengthsof the shaftThe optimal implant for everycase due to threads available indifferent lengths

Available in steel andtitaniumAll headless compression screwsfrom Synthes are availablein stainless implant-grade steeland high-quality biocompatibletitanium alloy (TAN)

HCS 4.5/6.5. The countersinkablecompression screw.

Features and benefits

Page 5: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

Synthes 3

Functional principle: Lag screwtechnique with compression sleeve

Step 1:Screw insertionInsert the screw into the bone withthe compression sleeve.

Step 2:Closure of gap and compressionOnce the tip of the compression sleevelies on the bone, the fracture gap isclosed and compressed by turning thesleeve.

Step 3:CountersinkingOnce the desired degree of compres-sion is reached, the screw is countersunkinto the bone with the screwdriverwhile the compression sleeve is heldstationary. During countersinking,no additional compression is generated.

Page 6: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

4 Synthes HCS 4.5/6.5 Instructions for Use

Indications

HCS 4.5Fracture, osteoarthritis, or deformity of small to large bones.

Examples:− Calcaneus− Talus− Metatarsus− Distal and proximal tibia− Distal femur− Proximal humerus

HCS 6.5Fracture, osteoarthritis, or deformity of small to large bones.

Examples:− Calcaneus− Talus− Distal and proximal tibia− Distal femur

Page 7: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

Synthes 5

Surgical Technique for HCS 4.5 and 6.5

1Insert the guide wire

Instruments

HCS 4.5

02.226.000 Guide Wire � 1.6 mm, length 220 mmor02.226.001 Guide Wire � 1.6 mm with trocar tip, length 220 mm, Stainless Steel

312.770 Protection Sleeve 9.5/7.0

312.760 Drill Sleeve 7.0/3.2

312.750 Drill Sleeve 3.2/1.6

312.740 Trocar � 1.6 mm

HCS 6.5

292.680 Guide Wire � 2.8 mm, length 300 mmor02.227.001 Guide Wire � 2.8 mm with trocar tip, length 300 mm, Stainless Steel

312.090 Protection Sleeve 15.5/13.0

312.050 Protection Sleeve 12.0/8.5

312.080 Drill Sleeve 8.5/2.8

312.020 Trocar � 2.8 mm

After a stab incision, advance the drill sleeve assemblythrough the soft tissues until it reaches the bone.

While monitoring with the image intensifier, advance theguide wire through the drill sleeve assembly until the threadtip is anchored in the far cortex of the bone.

Warning: Do not forcefully insert the guide wire as it maycause bending.

Page 8: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

Surgical Technique for HCS 4.5 and 6.5

2Determine screw and thread length

Instruments

HCS 4.5

03.226.030 Direct Measuring Device for HCS 4.5

312.770 Protection Sleeve 9.5/7.0

HCS 6.5

03.227.030 Direct Measuring Device for HCS 6.5

312.090 Protection Sleeve 15.5/13.0

312.050 Protection Sleeve 12.0/8.5

Remove the drill sleeve. Slide the narrow end of the measur-ing device through the protection sleeve and over the guidewire until it reaches the bone.

The measurement on the measuring device shows the depthin millimeters of the guide wire in the bone. This depth indi-cates the appropriate screw length.

Important: Only use the guide wire in its prescribed lengthto ensure correct measurement. If the screw is to be counter-sunk below the surface of the bone, subtract the appropriatescrew length. If a large fracture gap needs to be closed, sub-tract more.

6 Synthes HCS 4.5/6.5 Instructions for Use

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The position of the fracture line determines the thread length:

Correct thread lengthThe shaft thread lies below the fracture gap and completelywithin the distal fragment during compression. Fragmentscan be compressed.

Incorrect thread lengthThe shaft thread lies above the fracture gap or the osteotomy. Fragments cannot be compressed.

Synthes 7

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Surgical Technique for HCS 4.5 and 6.5

8 Synthes HCS 4.5/6.5 Instructions for Use

3Predrilling

Instruments

HCS 4.5

03.226.039 Drill Bit � 3.2 mm, cannulated

312.770 Protection Sleeve 9.5/7.0

312.760 Drill Sleeve 7.0/3.2

HCS 6.5

310.630 Drill Bit � 5.0 mm, cannulated

312.090 Protection Sleeve 15.5/13.0

312.050 Protection Sleeve 12.0/8.5

Predrilling facilitates the insertion of the screw in densebone.

Insert the drill sleeve in the protection sleeve. Slide the cannulated drill bit over the guide wire and predrill to the desired depth.

Remove the drill sleeve and verify the appropriate drillingdepth with the image intensifier.

Note: Do not drill beyond the tip of the guide wire. Slowlypull the drill bit straight out while running the power tool in“forward mode” to ensure that the guide wire stays in place.

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90°

Synthes 9

4Option: Predrilling for head

Instruments

HCS 4.5

03.226.042 Drill Bit for predrilling for screw head, cannulated, for HCS 4.5

312.770 Protection Sleeve 9.5/7.0

HCS 6.5

03.227.042 Drill Bit for predrilling for screw head, cannulated, for HCS 6.5

312.090 Protection Sleeve 15.5/13.0

312.050 Protection Sleeve 12.0/8.5

The corticalis can be predrilled with the drill bit to facilitatehead insertion in dense bone and to prevent the bone fromcracking.

Slide the drill bit with the protection sleeve over the guidewire and carefully predrill the corticalis.

Note: The depth of predrilling depends on the inclination ofthe guide wire to the bone. It is necessary to predrill only tothe first marking in cases where angulation is ± 90°. An an-gulation of ± 45° requires a deeper predrilling to the secondmarking.

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Surgical Technique for HCS 4.5 & 6.5

10 Synthes HCS 4.5/6.5 Instructions for Use

5Pick up screw

Instruments

HCS 4.5

03.226.033 Compression Sleeve for HCS 4.5

319.970 Screw Forceps, self-holding, length 85 mm

HCS 6.5

03.227.033 Compression Sleeve for HCS 6.5

319.970 Screw Forceps, self-holding, length 85 mm

To remove a screw from the screw rack, pick it up with thescrew forceps and twist the compression sleeve over thehead of the screw.

Attention: Do not remove the screw with the compressionsleeve directly from the screw rack. The screw rack could bedamaged.

6Insert screw and compress fragments

Instruments

HCS 4.5

03.226.033 Compression Sleeve for HCS 4.5

03.226.037 Handle for Compression Sleeve for HCS 4.5

312.770 Protection Sleeve 9.5/7.0

03.226.038 Attachment for Compression Sleeve for HCS 4.5

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Synthes 11

HCS 6.5

03.227.033 Compression Sleeve for HCS 6.5

03.227.037 Handle for Compression Sleeve for HCS 6.5

312.090 Protection Sleeve 15.5/13.0

03.227.038 Attachment for Compression Sleeve for HCS 6.5

Slide the compression sleeve handle into the compressionsleeve. Insert the screw assembly over the guide wire. Insertthe screw into the bone by turning the compression sleeveuntil the fracture gap or the osteotomy is closed and com-pressed.

Option: Screw insertion can also be performed with the useof a power drill. Slide the attachment for compression sleeveinto the compression sleeve and connect it to the power drill.Warning: Insert the screw into the bone and stop before thecompression sleeve touches the bone. Close and compressmanually by using the handle.

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Surgical Technique for HCS 4.5 and 6.5

12 Synthes HCS 4.5/6.5 Instructions for Use

Optional instruments

for use with 4.5 mm screws

03.226.034 Sleeve for Compression Sleeve for HCS – Headless Compression Screw � 4.5 mm

for use with 6.5 mm screws

03.227.034 Sleeve for Compression Sleeve for HCS – Headless Compression Screw � 6.5 mm

In osteoporotic bone, an additional sleeve should be placedover the compression sleeve before compressing the fractureor osteotomy to prevent the compression sleeve from pierc-ing the cortex.

Notes– Verify the correct position of the shaft thread in the distal

fragment using the image intensifier. If the thread lies overthe fracture gap or the osteotomy, the gap cannot be com-pressed.

– Carefully tighten the screw with the compression sleeve.

Warning: Forceful tightening could cause stripping of theshaft thread.

If an inadvertent event (e.g.: compression loss) makes screwremoval necessary, follow the instructions on page 15.

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Synthes 13

7Countersink screw

Instruments

HCS 4.5

03.226.033 Compression Sleeve for HCS 4.5

03.226.041 Screwdriver, cannulated, Stardrive T15

HCS 6.5

03.227.033 Compression Sleeve for HCS 6.5

03.227.041 Screwdriver, cannulated, hexagonal

Remove the compression sleeve handle and slide the cannu-lated screwdriver through the compression sleeve and intothe recess of the screw.

Countersink the screw by turning the screwdriver shaftclockwise, while simultaneously holding the compressionsleeve stationary.

Verify the screw position with the image intensifier. Ensurethat the screw head is properly countersunk: it should notproject from the surface, while the screw tip should not penetrate the distal cortex. Remove and dispose of the guidewire.

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14 Synthes HCS 4.5/6.5 Instructions for Use

Color markingsThe color markings on the screwdriver shaft indicate the position of the screwdriver tip and the head thread of the screw in the bone.

Green mark at the top end of thecompression sleeveThe screw is fully threaded into thecompression sleeve and the screwdrivertip is seated correctly in the recess ofthe screw.

Yellow mark at the top end of thecompression sleeveThe top end of the head thread is evenwith the bone surface.

Note: If the screw is inserted at an angle, it must be countersunk furtherthan the yellow mark so that itdoes not project from the surface.

Red mark at the top end of thecompression sleeveThe top end of the head thread is approximately 2 mm below the bonesurface.

Surgical Technique for HCS 4.5 and 6.5

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Screw Extraction

Instruments

HCS 4.5

03.226.033 Compression Sleeve for HCS 4.5

03.226.041 Screwdriver, cannulated, Stardrive T15

314.116 Screwdriver Shaft, Stardrive T15

311.440 T-Handle with Quick Coupling

HCS 6.5

03.227.033 Compression Sleeve for HCS 6.5

03.227.041 Screwdriver, cannulated, hexagonal

313.930 Screwdriver, hexagonal, for Screw Removalor314.040 Screwdriver Shaft, hexagonal, for Screw Removal

For removal of the HCS 4.5, use the Stardrive T15 screw-driver shaft with the T-Handle. For removal of HCS 6.5, useone of the screwdrivers for screw removal.

If the screw strips, use the following procedure:

Thread the compression sleeve over the screw head thread.Insert the cannulated screwdriver through the compressionsleeve into the recess of the screw.

Remove the screw by simultaneously pulling on the compres-sion sleeve and turning both the cannulated screwdriver and the compression sleeve in a counterclockwise direction.

Synthes 15

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3.5 mm

16 Synthes HCS 4.5/6.5 Instructions for Use

Implants – HCS 4.5

HCS 4.5 – Headless Compression Screw, short thread

Art. No. Screw Shaft thread length (mm) length (mm)* L S

0X.226.620 20 7

0X.226.622 22 7

0X.226.624 24 7

0X.226.626 26 7

0X.226.628 28 7

0X.226.630 30 7

0X.226.632 32 7

0X.226.634 34 7

0X.226.636 36 7

0X.226.638 38 7

0X.226.640 40 8

0X.226.642 42 8

0X.226.644 44 9

0X.226.646 46 9

0X.226.648 48 9

0X.226.650 50 10

0X.226.652 52 10

0X.226.654 54 11

0X.226.656 56 11

0X.226.658 58 11

0X.226.660 60 12

0X.226.665 65 13

0X.226.670 70 14

0X.226.675 75 15

0X.226.680 80 16

* Shaft thread length is approximately 20% of the screwlength.

X=2: Stainless SteelX=4: Titanium Alloy (TAN)All screws are also available sterile packed.

Only available sterile packed:Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.226.685S 85 17

0X.226.690S 90 18

0X.226.695S 95 19

0X.226.700S 100 20

0X.226.705S 105 21

0X.226.710S 110 22

L

S

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3.5 mm

Implants – HCS 4.5

HCS 4.5 – Headless Compression Screw, long thread

Art. No. Screw Shaft thread length (mm) length (mm)* L S

0X.226.730 30 12

0X.226.732 32 12

0X.226.734 34 12

0X.226.736 36 14

0X.226.738 38 14

0X.226.740 40 16

0X.226.742 42 16

0X.226.744 44 18

0X.226.746 46 18

0X.226.748 48 18

0X.226.750 50 20

0X.226.752 52 20

0X.226.754 54 22

0X.226.756 56 22

0X.226.758 58 22

0X.226.760 60 24

0X.226.765 65 26

0X.226.770 70 28

0X.226.775 75 30

0X.226.780 80 32

* Shaft thread length is approximately 40% of the screwlength.

X=2: Stainless SteelX=4: TANAll screws are also available sterile packed.

Only available sterile packed:Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.226.785S 85 34

0X.226.790S 90 36

0X.226.795S 95 38

0X.226.800S 100 40

0X.226.805S 105 42

0X.226.810S 110 44

Synthes 17

3.5 mm

L

S

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18 Synthes HCS 4.5/6.5 Instructions for Use

Instruments – HCS 4.5

Standard instruments

02.226. 000 Guide Wire � 1.6 mm with threaded tipwith trocar, length 220 mm, Stainless Steel

312.770 Protection Sleeve 9.5/7.0, for PercutaneousInsertion of Cannulated Screws � 4.5 mm

312.760 Drill Sleeve 7.0/3.2, for PercutaneousInsertion of Cannulated Screws � 4.5 mm

312.750 Drill Sleeve 3.2/1.6, for PercutaneousInsertion of Cannulated Screws � 4.5 mm

312.740 Trocar � 1.6 mm, for PercutaneousInsertion of Cannulated Screws � 4.5 mm

03.226.030 Direct Measuring Device for HCS –Headless Compression Screw � 4.5 mm

03.226.039 Drill Bit � 3.2/1.7 mm, cannulated, length225 mm, 4 flute, for Quick Coupling

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03.226.033 Compression Sleeve for HCS – Headless Compression Screw � 4.5 mm

03.226.037 Handle for Compression Sleeve for HCS –Headless Compression Screw � 4.5 mm

03.226.038 Attachment for Compression Sleeve forHCS – Headless Compression Screw � 4.5 mm

03.226.041 Screwdriver, cannulated, Stardrive, T15,for HCS – Headless Compression Screw� 4.5 mm

319.970 Screw Forceps, self-holding, length 85 mm

319.350 Cleaning Stylet � 1.6 mm, for CannulatedInstruments

03.226.042 Drill Bit for predrilling for screw head, cannulated, for HCS – Headless Compres-

sion Screw � 4.5 mm

Synthes 19

03.226.034 Sleeve for Compression Sleeve for HCS –Headless Compression Screw � 4.5 mm

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20 Synthes HCS 4.5/6.5 Instructions for Use

Optional instruments

02.226. 001 Guide Wire � 1.6 mm with trocar tip,length 220 mm, Stainless Steel

03.226.040 Tap, cannulated, length 225 mm, for HCS– Headless Compression Screw � 4.5 mm

311.440 T-Handle with Quick Coupling

319.260 Cleaning Brush � 1.75 mm, forCannulated Instruments

314.116 Screwdriver Shaft Stardrive 3.5, T15, self-holding, for AO/ASIF Quick Coupling

Instruments – HCS 4.5

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4.5 mm

Implants – HCS 6.5

Synthes 21

HCS 6.5 – Headless Compression Screw, short thread

Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.227.030 30 16

0X.227.035 35 16

0X.227.040 40 16

0X.227.045 45 16

0X.227.050 50 16

0X.227.055 55 16

0X.227.060 60 16

0X.227.065 65 16

0X.227.070 70 16

0X.227.075 75 16

0X.227.080 80 16

0X.227.085 85 16

0X.227.090 90 16

0X.227.095 95 16

0X.227.100 100 16

0X.227.105 105 16

0X.227.110 110 16

0X.227.115 115 16

0X.227.120 120 16

X=2: Stainless SteelX=4: TANAll screws are also available sterile packed.

Only available sterile packed:Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.227.125S 125 16

0X.227.130S 130 16

L

S

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4.5 mm

22 Synthes HCS 4.5/6.5 Instructions for Use

HCS 6.5 – Headless Compression Screw, long thread

Art. No. Screw length Shaft thread length (mm) length (mm) L S

0X.227.245 45 32

0X.227.250 50 32

0X.227.255 55 32

0X.227.260 60 32

0X.227.265 65 32

0X.227.270 70 32

0X.227.275 75 32

0X.227.280 80 32

0X.227.285 85 32

0X.227.290 90 32

0X.227.295 95 32

0X.227.300 100 32

0X.227.305 105 32

0X.227.310 110 32

0X.227.315 115 32

0X.227.320 120 32

X=2: Stainless SteelX=4: TANAll screws are also available sterile packed.

Only available sterile packed:Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.227.325S 125 32

0X.227.330S 130 32

L

S

Implants – HCS 6.5

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Instruments – HCS 6.5

Standard instruments

292.680 Guide Wire � 2.8 mm with threaded tipwith trocar, length 300 mm, Stainless Steel

312.050 Protection Sleeve 12.0/8.5

312.080 Drill Sleeve 8.5/2.8

312.090 Drill Sleeve 15.5/13.0

312.020 Trocar � 2.8 mm

03.227.030 Direct Measuring Device for HCS –Headless Compression Screw � 6.5 mm

310.630 Drill Bit � 5.0 mm, cannulated, length300/250 mm, 3-flute, for Quick Coupling

Synthes 23

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Instruments – HCS 6.5

24 Synthes HCS 4.5/6.5 Instructions for Use

319.460 Cleaning Stylet � 2.8 mm, for CannulatedInstruments

03.227.033 Compression Sleeve for HCS – HeadlessCompression Screw � 6.5 mm

03.227.037 Handle for Compression Sleeve for HCS –Headless Compression Screw � 6.5 mm

03.227.038 Attachment for Compression Sleeve for HCS – Headless Compression Screw � 6.5 mm

03.227.041 Screwdriver, hexagonal, cannulated, for HCS – Headless Compression Screw � 6.5 mm

319.970 Screw Forceps, self-holding, length 85 mm

03.227.042 Drill Bit for predrilling for screw head, cannulated, for HCS – Headless

Compression Screw � 6.5 mm

03.227.034 Sleeve vor Compression Sleeve for HCS –Headless Compression Screw � 6.5 mm

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Optional instruments

311.689 Tap, cannulated, for Cannulated Screws� 6.5 and 7.3 mm

02.227.001 Guide Wire � 2.8 mm with trocar tip,length 300 mm, Stainless Steel

03.111.002 Drill Bit � 5.0 mm, cannulated, calibrated,length 300/250 mm, 3-flute, for QuickCoupling

319.240 Cleaning Brush � 2.9 mm, for CannulatedInstruments

314.040 Screwdriver Shaft, hexagonal, for ScrewRemoval

313.930 Screwdriver, hexagonal, for CannulatedScrews � 6.5 and 7.3 mm, for ScrewRemoval

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Page 28: HCS 4.5/6.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...2 Synthes HCS 4.5/6.5 Instructions for Use Self-drilling and self-tapping tip

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