instruction - rimanere.com.mxrimanere.com.mx/pdf/placas/sistema7/ficha_tecnica.pdf · Lp. Catalogue...

$: instruction - rimanere.com.mxrimanere.com.mx/pdf/placas/sistema7/ficha_tecnica.pdf · Lp. Catalogue No. Name Pcs 1 40.5725.100 Aiming block [3.4023] 1 ... • Comminuted fractures$
IMPLANTS • INSTRUMENT SETS •

SURGICAL TECHNIQUE •

instruction

LOCKING PLATES 7.0ChLP

0197ISO 9001ISO 13485

48A

3ChM Ltd., Lewickie 3b, 16-061 Juchnowiec K., POLAND

tel. +48 85 713-13-20 ÷ 25 fax +48 85 713-13-19 e-mail: [email protected]

TABLE OF CONTENT

Edition 48 of 05.09.2012 reviewed 16.01.2013r.

I. INTRODUCTION ....................................................................................................................................... 4

II. PLATE SELECTION AND CONTOURING .............................................................................................. 5VI.1. INDICATIONS .....................................................................................................................................................................5

7.0ChLP condylar femoral plate .....................................................................................................................................................6

VII. CATALOGUE PAGES ............................................................................................................................ 6VII.1. PLATES .............................................................................................................................................................................6

7.0ChLP condylar tibial plate ..........................................................................................................................................................87.0ChLP wide tibial plate ..............................................................................................................................................................107.0 ChLP proximal laterall tibial plate ...........................................................................................................................................127.0ChLP proximal femoral plate ...................................................................................................................................................147.0ChLP wide compression limited contact plate ........................................................................................................................157.0ChLP screw Ø5,0 ....................................................................................................................................................................167.0ChLP conical self-tapping screw .............................................................................................................................................16

VII.2. SCREWS..........................................................................................................................................................................16Cortical screw Ø4,5 ......................................................................................................................................................................177.0ChLP cerclage screws .............................................................................................................................................................177.0ChLP distance screw ...............................................................................................................................................................177.0ChLP screw hole insert ...........................................................................................................................................................177.0ChLP cannulated screw Ø7.3x16 ...........................................................................................................................................187.0ChLP cannulated screw Ø7.3 .................................................................................................................................................187.0ChLP conical cannulated screw Ø7.3x16 ...............................................................................................................................187.0ChLP conical cannulated screw Ø7.3 .....................................................................................................................................187.0ChLP cancellous screw Ø6.5 ..................................................................................................................................................197.0ChLP cancellous screw Ø5.4 ..................................................................................................................................................19Stand for screws 7.0ChLP ............................................................................................................................................................20

VII.3. INSTRUMENTS FOR 7.0ChLP PLATE ...........................................................................................................................21A. Universal instrument set ..........................................................................................................................................................21B. Additional instruments ..............................................................................................................................................................23

VIII. SURGICAL TECHNIQUE ................................................................................................................... 24VIII.1. TEMPORARY PLATE ATTACHMENT ............................................................................................................................24

VIII.2. LOCKING SCREW Ø5.0 INSERTION ............................................................................................................................25

VIII.3. THE USE OF AIMING BLOCK .......................................................................................................................................28

VIII.4. CORTICAL SCREW Ø4.5 INSERTION ..........................................................................................................................29

VIII.5. LOCKING SCREW Ø7.3 INSERTION ............................................................................................................................31

IX. POSTOPERATIVE TREATMENT ......................................................................................................... 32

X. IMPLANT REMOVAL ............................................................................................................................ 32

XI. INSTRUCTIONS FOR USE .................................................................................................................. 33

mailto://[email protected]



INTRODUCTION

The main purpose of surgical treatment of bone fractures is toreconstruct the anatomical bone structure and to restore its func-tion.Internal stabilization with locking plates enables accuratefracturereduction,stablefixation,bloodflowpreservationandfunctional activation of injured limb.

System ChLP consists of titanium plates and screws combininglocking screws technique with conventional treatment techniquesusing plates. This system is the improvement of existingstabilization methods. Locking screws system enables angularfixationusingconventionalsurgicaltechniques.Itisparticularlyindicated in:•multifragmental fractures;•non-unions or malunions;•osteopenia;•osteotomy stabilization;•whenapplyingconventionalscrewsisinsufficientordoesnot•bring expected effects.

Locking plates are provided with holes A for conventional corticalscrews with or without compression and with threaded holes Bfor locking screws.Compression holes designed in ChLP System enable compres-sion in both directions..

Plates design allows to perform classical dynamic compression.

Advantages of using locking plates system over conventionalmethods of fracture treatment using plates:•enablestablefixationensuringangularstabilization infractu-

re site;•enable compression using conventional cortical and cancello-

us screws, combination with conventional and locking screws is available;

•reducedbone-platecontactensuresbetterbloodflowofpe-rimplant tissues;

•locking screws enable uni-cortical plate position against the-bone;

•plates can be contoured to match the anatomical bone shape-that is particular important in periarticular fractures.

Following instruction does not refer to particular fracture typesas the locking plates system includes different plates that arerelevant to many different fractures.

ChLP System was divided as follows:•4.0ChLP System;•4.5ChLP System;•5.0ChLP System;•7.0ChLP System.

Division is based on the screw head diameter however, screwswith different cortical thread diameter in one system range areavailable.

Additionally, systems were differentiated with colors as follows:•4.0ChLP System – green;•4.5ChLP System – gold;•5.0ChLP System – brown;•7.0ChLP System – blue.

Before product usage, read the Instructions For Use carefully. The IFU is supplied with the product and attached at the endof this document. It includes, among others: the indications, contraindications, adverse effects, warnings and recommenda-tions associated with product usage.

I. INTRODUCTION

A B



INTRODUCTION

Wide size range of locking plates enables proper plate selection.Locking plate contouring is not recommended due to possiblity of threaded holes damaging.Bottom surface of the plate does not have to contact the bone if locking screws are used. There is no necessity of accurate platescontouring. Advanced shaped plates do not require additional bending in most cases.

If the plate bending is necessary, remember not to deform threaded holes excessively.

•perform it between locking holes;•do not bend the plate more than 20° – 25°;•do not bend the plate back and forth;•before bending, insert the locking screws in the bending area, that decreases the threaded holes deformation degree.

II. PLATE SELECTION AND CONTOURING

VII.1. INDICATIONS

7.0 locking plate system is designed to stabilize the fracture of various long bones such as:•femoral bone,•tibial bone

Straight wide plates are mainly used to stabilize the shafts of bone fractures. Shape plates are used for metaphysial bone fractures as well as simple, comminuted, wedge-shaped lateral and medial fractures, condylar fractures and the ones combined with the shaft of a bone.

mailto://[email protected]

6

L R

L

ChM Ltd., Lewickie 3b, 16-061 Juchnowiec K., POLANDtel. +48 85 713-13-20 ÷ 25 fax +48 85 713-13-19 e-mail: [email protected]

IMPLANTS

VIII. CATALOGUE PAGESVIII.1. PLATES

Catalogue No.

Titanium

O L[mm] left right

4 153 3.4023.504 3.4024.5046 195 3.4023.506 3.4024.5068 237 3.4023.508 3.4024.508

10 279 3.4023.510 3.4024.510

O - number of threaded holes in the shaft of the plate

available4 - 16

holes(153 mm - 403 mm)

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

Titanium 3.1664.030÷1003.5221.030÷100

Ø7,3

Palette for 7.0ChLP plates - 3.4023/3.4024

Lp. Catalogue No. Name Pcs

1 40.5725.100 Aiming block [3.4023] 1

40.5

704.

310

40.5

704.

5102 40.5725.200 Aiming block [3.4024] 1

3 40.5708.000 Protective guide 9.0/7.0 2

4 40.5704.410 Palette 1

5 12.0750.100 Container solid bottom 1/1 595x275x86mm 1

6 12.0750.200 Perforated aluminum lid1/1 595x275x15mm Szara 1

implants not included; with additional instruments

7.0ChLP condylar femoral plate



Indications

•Comminuted fractures of the distal part of the femoral bone and fractures extending to the shaft of the femur.•Supracondylar fractures.•Articular and extra-articular condylar fractures.•Non-union or malunions of fractured bone.

Contraindications

Absolute•Health condition precluding surgery.•Allergic reactions to the metal from which the implant is made.•Active infection.

Relative•Weakened bone (by disease, infection or prior implantation) making it impossible to install/stabilize the implant properly.•Abnormal perfusion of fracture area or surgical site.•Excessive obesity.•Lack of adequate tissue coverage.•Psychiatric disorders or the disorders of the musculoskeletal system which may create a risk of fusion failure or complications

in the postoperative period.•Othermedicalconditionsthatexcludethepotentialbenefitsofthetreatment.

The patient’s position

Procedure stages

•Reduction of fracture and stabilization of the fracture fragments with Kirschner wires.•The choice of implants - determining the length and position of the implant.•Insertion of the plate and its positioning.•Temporary stabilization of the implant using Kirschner wires.•Introduction of the screws to the distal parts of the plate.•Stabilization of the shaft using locking or compression screws.

Surgical approach

LATERAL APPROACH: the lateral incision of about 80 mm in the proximal direction shall begin from Gerdy’s tubercle. If ne-cessary, the incision may be lengthened. The incision is recom-mended for extra-articular fractures and simple articular and me-taphysial fractures without displacement.

ANTERIOR-LATERAL APPROACH: perform the parapatellar in-cision. Perform the arthrotomy as to expose the articulation and reduce the fragments of the fractured bone; pull the patel-la medially and widen the cut adequately to expose the femo-ral condyle. The parapatellar incision is recommended for more complex articular comminuted fractures.

8

L

LR


IMPLANTS

Catalogue No.

Titanium

O L[mm] left right

4 147 3.4013.504 3.4014.5045 168 3.4013.505 3.4014.5056 189 3.4013.506 3.4014.5068 231 3.4013.508 3.4014.508


available4 - 12




1 40.5724.100 Aiming block [3.4013] 1

40.5

704.

320

40.5

704.

5202 40.5724.200 Aiming block [3.4014] 1


4 40.5704.420 Palette 1




Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

7.0ChLP condylar tibial plate



Indications

•Articular and extra-articular, metaphysial and epiphysial comminuted fractures of the proximal part of the tibia and fractures extending to the shaft of the tibia.

•Non-union or malunions of fractured bone

Contraindications

Absolute:•Health condition precluding surgery.•Allergic reactions to the metal from which the implant is made.•Active infection.

Relative:•Weakened bone (by disease, infection or prior implantation) making it impossible to install/stabilize the implant properly.•Abnormal perfusion of fracture area.•Excessive obesity.•Lack of adequate tissue coverage.•Psychiatric disorders or the disorders of the musculoskeletal system which may create a risk of fusion failure or complications



Procedure stages

•Reduction of fracture and stabilization of the fracture fragments using Kirschner wires. •The choice of implants - determining the length and position of the implant.•Insertion of the plate and its positioning.•Temporary stabilization of the implant using Kirschner wires.•Introduction of the screws in the distal parts of the plate.•Stabilization of the shaft using locking or compression screws.•Positioning of the plate using the compression screw in the extended hole.•Making X-RayfilminbothA-Pandlateralpositionastomakesuretheplateandscrewsarepositionedproperly.•Closing the wound.

Surgical approach

Lateral S incision - recommended for simple articular and extra--articular fractures

Straight anterior-lateral incision - recommended for more com-plex articular fractures.

Anterior-lateralapproach.Theincisionperformedbetweenthetibiaandfibulaboneandshouldbeginapproximately1cmproximallyfromGer-dy’s tubercle for a desired length of the plate. In the minimally invasive technique, a short cut and additional cuts for the access to the holes of the shaft of the plate should be performed.

10

LR

L


IMPLANTS

Catalogue No.

Titanium

O L[mm] left right

4 135 3.4009.504 3.4010.5046 177 3.4009.506 3.4010.5068 229 3.4009.508 3.4010.50810 261 3.4009.510 3.4010.510


available3 - 14


Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5



1 40.5704.340 Palette 1

40.5

704.

540



bezimplantów;implantsnotincluded;безимплантатов

7.0ChLP wide tibial plate



Indications



Contraindications

Absolute:• Health condition precluding surgery.•Allergic reactions to the metal from which the implant is made.•Active infection.




Procedure stages


Surgical approach

Lateral S incision - recommended for simple articular and extra--articular fractures

Straight anterior-lateral incision - recommended for more com-plex articular fractures.


12

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IMPLANTS

Catalogue No.

Titanium

O L[mm] left right

3 149 3.4089.503 3.4090.5034 170 3.4089.504 3.4090.5046 212 3.4089.506 3.4090.5068 254 3.4089.508 3.4090.508


available2 - 10




1 40.5709.100 Aiming block [3.4089] 1

40.5

704.

360

40.5

704.

5602 40.5709.200 Aiming block [3.4090] 1


4 40.5704.460 Palette 1




Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

7.0ChLP proximal lateral tibial plate



Indications



Contraindications

Absolute:•Health condition precluding surgery.•Allergic reactions to the metal from which the implant is made.•Active infection.




Procedure stages


Surgical approach

Lateral S incision - recommended for simple articular and extra--articular fractures Straight anterior-lateral incision - recommended for more com-

plex articular fractures.


14

L

LR


IMPLANTS

LeftCatalogue No.,

O L [mm] Titanium 2 137 3.7023.5024 176 3.7023.5046 215 3.7023.5068 254 3.7023.508

10 293 3.7023.51012 332 3.7023.51214 371 3.7023.51416 410 3.7023.516

RightCatalogue No.

O L [mm] Titanium 2 137 3.7022.5024 176 3.7022.5046 215 3.7022.5068 254 3.7022.508

10 293 3.7022.51012 332 3.7022.51214 371 3.7022.51416 410 3.7022.516


Titanium 3.1448.016-110

Ø5,0

Titanium 3.1443.016-140

Ø4,5

Titanium 3.1448.016-110

Ø5,0

Titanium 3.1664.030-095

Ø7,3



1 40.5732.100 Aiming block [3.7023] 1

40.5

704.

390

40.5

704.

5902 40.5732.200 Aiming block [3.7022] 1


4 40.5704.490 Palette 1




7.0ChLP proximal femoral plate

15

L

17,5

5,0


IMPLANTS

Catalogue No.

O L[mm] Titanium

6 142 3.3155.5068 184 3.3155.50810 226 3.3155.51012 268 3.3155.51214 310 3.3155.514

O -number of threaded holes in the plate

available4 - 18


Palette for 7.0ChLP plates - płytki proste


1 40.5704.350 Palette 1

40.5

704.

550




Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

7.0ChLP wide compression limited contact plate

16

L

Ø5,0

Ø7,0

samogwintującyself-tappingсамонарезающий


Ø7,0

Ø5,0

L

3,5 T25

Catalogue No.

L[mm] Titanium 30 3.1449.030 3.5216.03035 3.1449.035 3.5216.03540 3.1449.040 3.5216.04045 3.1449.045 3.5216.04550 3.1449.050 3.5216.05055 3.1449.055 3.5216.05560 3.1449.060 3.5216.06065 3.1449.065 3.5216.06570 3.1449.070 3.5216.07075 3.1449.075 3.5216.07580 3.1449.080 3.5216.08085 3.1449.085 3.5216.08590 3.1449.090 3.5216.090



Ø Core 4.0

Ø Drill with scale 40.5651.220 4.0

Guidesleeve 40.5705.040 7.0/4.0

Screwdriver tip 40.5686.000 S3.5

Screwdriver tip 40.5684.000 T25

Tap 40.5646.000 5.0


IMPLANTS

VIII.2. SCREWS

7.0ChLP screw Ø5,0 7.0ChLP conical self-tapping screw

3,5 T25

Catalogue No.

L[mm] Titanium 16 3.1448.016 3.5210.01618 3.1448.018 3.5210.01820 3.1448.020 3.5210.02022 3.1448.022 3.5210.02224 3.1448.024 3.5210.02426 3.1448.026 3.5210.02628 3.1448.028 3.5210.02830 3.1448.030 3.5210.03032 3.1448.032 3.5210.03234 3.1448.034 3.5210.03436 3.1448.036 3.5210.03638 3.1448.038 3.5210.03840 3.1448.040 3.5210.04042 3.1448.042 3.5210.04244 3.1448.044 3.5210.04446 3.1448.046 3.5210.04648 3.1448.048 3.5210.04850 3.1448.050 3.5210.05052 3.1448.052 3.5210.05254 3.1448.054 3.5210.05456 3.1448.056 3.5210.05658 3.1448.058 3.5210.05860 3.1448.060 3.5210.06065 3.1448.065 3.5210.06570 3.1448.070 3.5210.07075 3.1448.075 3.5210.07580 3.1448.080 3.5210.08085 3.1448.085 3.5210.08590 3.1448.090 3.5210.09095 3.1448.095 3.5210.095100 3.1448.100 3.5210.100105 3.1448.105 3.5210.105110 3.1448.110 3.5210.110

17

Catalogue No.

TITANIUM

3.1221.070

L

Ø5,0

Ø7,0

Ø7,0

L

Ø4,5

4,6

Ø8,0


Ø Core 3.0


Compression guide 40.4802.032 3.2



Tap 40.5647.000 HA4,5


IMPLANTS

7.0ChLP cerclage screwsCortical screw Ø4,5

Screwdriver 40.4746.000

7.0ChLP distance screw

7.0ChLP screw hole insert

3,5 T25

Catalogue No.

L[mm] Titanium

8 3.1448.008 3.5219.008

3,5 T25

Catalogue No.

L[mm] Titanium

8 3.1382.000 3.5220.000

3,5 T25

Catalogue No.

L[mm] Titanium 16 3.1443.016 3.1471.01618 3.1443.018 3.1471.01820 3.1443.020 3.1471.02022 3.1443.022 3.1471.02224 3.1443.024 3.1471.02426 3.1443.026 3.1471.02628 3.1443.028 3.1471.02830 3.1443.030 3.1471.03032 3.1443.032 3.1471.03234 3.1443.034 3.1471.03436 3.1443.036 3.1471.03638 3.1443.038 3.1471.03840 3.1443.040 3.1471.04042 3.1443.042 3.1471.04244 3.1443.044 3.1471.04446 3.1443.046 3.1471.04648 3.1443.048 3.1471.04850 3.1443.050 3.1471.05052 3.1443.052 3.1471.05254 3.1443.054 3.1471.05456 3.1443.056 3.1471.05658 3.1443.058 3.1471.05860 3.1443.060 3.1471.06062 3.1443.062 3.1471.06264 3.1443.064 3.1471.06466 3.1443.066 3.1471.06668 3.1443.068 3.1471.06870 3.1443.070 3.1471.07072 3.1443.072 3.1471.07274 3.1443.074 3.1471.07476 3.1443.076 3.1471.07678 3.1443.078 3.1471.07880 3.1443.080 3.1471.08085 3.1443.085 3.1471.08590 3.1443.090 3.1471.09095 3.1443.095 3.1471.095100 3.1443.100 3.1471.100105 3.1443.105 3.1471.105110 3.1443.110 3.1471.110

18

16

samowiercącyself-drillingсамосверлящий

L

Ø7,3

Ø9,0


5,0

Ø2,2

T30

Ø2,2

Catalogue No.

L[mm] Titanium 30 3.1664.030 3.5221.03035 3.1664.035 3.5221.03540 3.1664.040 3.5221.04045 3.1664.045 3.5221.04550 3.1664.050 3.5221.05055 3.1664.055 3.5221.05560 3.1664.060 3.5221.06065 3.1664.065 3.5221.06570 3.1664.070 3.5221.07075 3.1664.075 3.5221.07580 3.1664.080 3.5221.08085 3.1664.085 3.5221.08590 3.1664.090 3.5221.09095 3.1664.095 3.5221.095100 3.1664.100 3.5221.100

5,0

Ø2,2

T30

Ø2,2

Catalogue No.

L[mm] Titanium 30 3.1663.030 3.5222.03035 3.1663.035 3.5222.03540 3.1663.040 3.5222.04045 3.1663.045 3.5222.04550 3.1663.050 3.5222.05055 3.1663.055 3.5222.05560 3.1663.060 3.5222.06065 3.1663.065 3.5222.06570 3.1663.070 3.5222.07075 3.1663.075 3.5222.07580 3.1663.080 3.5222.08085 3.1663.085 3.5222.08590 3.1663.090 3.5222.09095 3.1663.095 3.5222.095100 3.1663.100 3.5222.100

L

Ø7,3

Ø9,0 Ø9,0

Ø9,0

16L

L

Ø7,3

Ø7,3


16

5,0

Ø2,2

T30

Ø2,2

Catalogue No.

L[mm] Titanium 30 3.1665.030 3.5224.03035 3.1665.035 3.5224.03540 3.1665.040 3.5224.04045 3.1665.045 3.5224.04550 3.1665.050 3.5224.05055 3.1665.055 3.5224.05560 3.1665.060 3.5224.06065 3.1665.065 3.5224.06570 3.1665.070 3.5224.07075 3.1665.075 3.5224.07580 3.1665.080 3.5224.08085 3.1665.085 3.5224.08590 3.1665.090 3.5224.09095 3.1665.095 3.5224.095

5,0

Ø2,2

T30

Ø2,2

Catalogue No.

L[mm] Titanium 30 3.1666.030 3.5223.03035 3.1666.035 3.5223.03540 3.1666.040 3.5223.04045 3.1666.045 3.5223.04550 3.1666.050 3.5223.05055 3.1666.055 3.5223.05560 3.1666.060 3.5223.06065 3.1666.065 3.5223.06570 3.1666.070 3.5223.07075 3.1666.075 3.5223.07580 3.1666.080 3.5223.08085 3.1666.085 3.5223.08590 3.1666.090 3.5223.09095 3.1666.095 3.5223.095


IMPLANTS

7.0ChLP cannulated screw Ø7.3x16

7.0ChLP cannulated screw Ø7.3

ØCore 5.2

ØKirschner wire 40.4815.220 2.0

Guidesleeve 40.5654.120/150 5.0/2.0

ØDrill with scale 40.5652.220 5.0/2.0

Guidesleeve 40.5654.150 5.0

Screwdriver tip 40.5687.000 S5


7.0ChLP conical cannulated screw Ø7.3x16

7.0ChLP conical cannulated screw Ø7.3

19

L5,0 T30

Catalogue No.

L[mm] Titanium 30 3.1383.030 3.5228.03035 3.1383.035 3.5228.03540 3.1383.040 3.5228.04045 3.1383.045 3.5228.04550 3.1383.050 3.5228.05055 3.1383.055 3.5228.05560 3.1383.060 3.5228.06065 3.1383.065 3.5228.06570 3.1383.070 3.5228.07075 3.1383.075 3.5228.07580 3.1383.080 3.5228.08085 3.1383.085 3.5228.08590 3.1383.090 3.5228.09095 3.1383.095 3.5228.095

Ø9,0

Ø6,5


3,5 T25

Catalogue No.

L[mm] Titanium 30 3.1380.030 3.5232.03035 3.1380.035 3.5232.03540 3.1380.040 3.5232.04045 3.1380.045 3.5232.04550 3.1380.050 3.5232.05055 3.1380.055 3.5232.05560 3.1380.060 3.5232.06065 3.1380.065 3.5232.06570 3.1380.070 3.5232.07075 3.1380.075 3.5232.07580 3.1380.080 3.5232.08085 3.1380.085 3.5232.08590 3.1380.090 3.5232.090

L

Ø5,4

Ø7,0



IMPLANTS

7.0ChLP cancellous screw Ø6.5

Ø core 3.0



Screwdriver tip 40.5687.000 S5


7.0ChLP cancellous screw Ø5.4

Ø core 3.2





20

40.5749.400


IMPLANTS

Stand for screws 7.0ChLP


1 40.5749.400 Stand for screws 7.0ChLP 1

40.5

749.

500






INSTRUMENTS

VIII.3. INSTRUMENTS FOR 7.0ChLP PLATE

1.Guidesleeve7.0/2.0[40.5705.020]2.Guidesleeve7.0/3.2[40.5705.032]3.Guidesleeve7.0/4.0[40.5705.040]

4. Compression guide 3.2 [40.4802.032]

8. Kirschner wire 2.0/220 [40.4815.220]

9. Setting-compressing screw 4.0/180 [40.5706.040]

10. Screw length measure [40.5675.100]

5. Drill with scale 3.2/220 [40.5650.220]6. Drill with scale 4.0/220 [40.5651.220]7. Cannulated drill with scale 5.0/2.2/220 [40.5652.220]

Lp. Catalogue No. Name Pcs1 40.5705.020 Guidesleeve7.0/2.0 2

40.5

702.

600

2 40.5705.032 Guidesleeve7.0/3.2 23 40.5705.040 Guidesleeve7.0/4.0 44 40.4802.032 Compression guide 3.2 15 40.5650.220 Drill with scale 3.2/220 26 40.5651.220 Drill with scale 4.0/220 27 40.5652.220 Cannulated drill with scale 5.0/2.2/220 28 40.4815.220 Kirschner wire 2.0/220 49 40.5706.040 Setting-compressing screw 4.0/180 210 40.5675.100 Screw length measure 111 40.4639.000 Depth measure 112 40.5686.000 Screwdriver tip S3.5-1/4 113 40.5684.000 Screwdriver tip T25-1/4 114 40.5270.400 Torque wrench 115 40.4250.000 Bender for plates 4/6 216 40.5707.032 Guidesleeve3.2 117 40.5654.150 Guidesleeve5.0 118 40.5654.120 Guidesleeve5.0/2.0 119 40.5687.000 Screwdriver tip kaniulowany S5-1/4 120 40.5685.000 Screwdriver tip kaniulowany T30-1/4 121 40.0672.000 Star cannulated screwdriver T30 122 40.0671.000 Star screwdriver T25 123 40.0320.000 Hexagonal screwdriver S3.5 124 40.4817.000 Cannulated screwdriver S5 125 40.5646.000 Tap 7,0ChLP -5.0 126 40.5647.000 Tap HA 4.5 127 40.4746.000 Screwdriver 128 40.5703.600 Stand for instrument set of 7.0ChLP plate 1

A. Universal instrument set



INSTRUMENTS

14. Torque wrench [40.5270.400]

15. Bender for plates 4/6 [40.4250.000]

28. Stand for instrument set of 7.0ChLP plate[40.5703.600]

17.Guidesleeve5.0[40.5654.150]18.Guidesleeve5.0/2.0[40.5654.120]

19. Cannulated screwdriver tip S5-1/4 [40.5687]20. Cannulated screwdriver tip T30-1/4 [40.5685]

16.Guidesleeve3.2[40.5707.032]

11. Depth measure [40.4639.000]

12. Screwdriver tip S3.5-1/4 [40.5686.000]13. Screwdriver tip T25-1/4 [40.5684.000]

27. Screwdriver [40.4746.000]

26. Cortical tap HA 4.5 [40.5647.000]

25. Tap 7.0ChLP - 5.0 [40.5646.000]

21. Star cannulated screwdriver T30 [40.0672.000]22. Star screwdriver T25 [40.0671.000]23. Hexagonal screwdriver S3.5 [40.0320.000]24. Cannulated screwdriver S5 [40.4817.000]



INSTRUMENTS

19. Cannulated screwdriver tip S5-1/4 [40.5687]20. Cannulated screwdriver tip T30-1/4 [40.5685]

B. Additional instruments


1 40.5708.000 Protective guide 9.0/7.0 22 40.5725.100 Aiming block [3.4023] 13 40.5725.200 Aiming block [3.4024] 14 40.5724.100 Aiming block [3.4013] 15 40.5724.200 Aiming block [3.4014] 16 40.5709.100 Aiming block [3.4089] 17 40.5709.200 Aiming block [3.4090] 18 40.5732.100 Aiming block [3.7023] 19 40.5732.200 Aiming block [3.7022] 1

1. Protective guide 9.0/7.0 [40.5708.000]

2. Aiming block 3.4023 [40.5725.100]3. Aiming block 3.4024 [40.5725.200]




Instruments not included in the instrument set [40.5702.600]

24

40.4815.220 40.4815.220

40.5706.040

40.5705.040


SURGICAL TECHNIQUE

The above description is not detailed instruction of conduct. The surgeon decides about choosing the operating procedure.

When fracture is reduced and the plate position is confirmed,determineits temporary location using Kirschner wires 2.0 [40.4815.220].Wires can be inserted in proximal holes of the plate and the mostdistal ones.

Confi rm the plate position is correct taking X-Ray ima-ge.

NOTE: The Setting-compressing screw 4.0/180 [40.5706.040] can be used to stabilize and tighten the plateup to the bone for temporary purposes. The screw is to be inserted via the Guide sleeve 7.0/4.0 [40.5705.040].

Locking screw Ø5.0 can be inserted in the hole after removal of the Setting-compressing screw 4.0/180.

Insert self drilling pin of setting-compressing screw.

Tightening the sleeve, pull the plateto the bone.

IX. SURGICAL TECHNIQUE

IX.1. TEMPORARY PLATE ATTACHMENT



SURGICAL TECHNIQUE


IX.1. TEMPORARY PLATE ATTACHMENT

Guide sleeve screwing

InserttheGuidesleeve7.0/4.0[40.5705.040] into the plate

Drilling the hole

Ream the hole using the Drill with scale 4.0/220 [40.5651.220] until the desire depth is reached

Hole depth measurement

OPTION I: Read the value on the Drill with scale [40.5651.220] or

IX.2. LOCKING SCREW Ø5.0 INSERTION

It is important to drill exactly in the axis of a locking hole. Use always the appropriate guide sleeve when drilling. The guide sleeve will ensure the locking screw take an axial position towards the hole of the plate and be correctly locked in the plate. Unprepared dril-ling of a hole can lead to: thread skewing and jamming the screw, incorrect screw locking and problems when removing the screws (thread seizure).



SURGICAL TECHNIQUE


OPTION II: use the Screw length measure [40.5675.100].

OPTION III: UnscrewtheGuidesleeve7.0/4.0[40.5705.040] anddefinethescrewlengthusingtheDepthme-asure [40.4639.000].



SURGICAL TECHNIQUE


Screw insertion

RemovetheGuidesleeve7.0/4.0[40.5705.040].

Insert the locking screw Ø5.0 using the Torque wrench [40.5270.400] and proper screwdriver tip.



SURGICAL TECHNIQUE


40.0671.000

40.5705.040

40.5708.000

IX.3. THE USE OF AIMING BLOCK

Most locking plates ChLP are available with aiming blocks, as additional complementary instruments. Using aiming blocks ensures proper fastening of gu-ide sleeves in the locking holes, in the epiphyseal part of the plate. It facilitates also the smooth conduct of the procedure, reduces its duration, and ensures that drilling is performed in the axis of the locking hole (note from point IV.2).

When aiming blocks are not used, the implantation can be incorrect. Improperly locked screws can cause com-plications when removing the plates.

Position the aiming block on the plate.

Tighten up with Star screwdriver T25 [40.0671.000].

Insert Protective sleeve 9.0/7.0 [40.5708.000] in the desired hole of the aiming block.

ThenscrewtheGuidesleeve7.0/4.0[40.5705.040] into the pla-te through the Protective sleeve 9.0/7.0.

NOTE!Further proceedings in accordance with the steps de-scribed in the point IV.2 on page 25



SURGICAL TECHNIQUE


Compression guide setting

Set the Compression guide 3.2 [40.4802.032] in desire po-sition:

1. Neutral position

Press the guide to the plate to achievethe neutral position for screw insertion

IX.4. CORTICAL SCREW Ø4.5 INSERTION

b. Compressive position

Move the guide without pressure to theedge of compression hole to achieve the com-pressionposition for screw insertion.

c. Angular position

Angular positioning of the guide is also available



SURGICAL TECHNIQUE


Screw insertion

Insert cortical screw Ø4.5


Insert the Depth neasure [40.4639.000] into the drilled hole until its hook anchors the outer surface of the opposite cortex

Drilling

Drill the hole through both cortices in desire position for the cor-ticalscrew Ø4.5 insertion using the Drill Ø3.2/220 [40.5650.220]

31

* **


SURGICAL TECHNIQUE


In the middle of the condylar part of the femoral plate [L-3.4023, R-3.4024], there is provided a larger hole for insertion of cannu-lated screw Ø7.3mm [3.1664.xxx].

Guide sleeve screwing

Screw in the Guide sleeve 9.0/5.0 [40.5654.150] along with theGuide sleeve 5.0/2.0 [40.5654.120] for Kirschner wire 2.0 insertion [40.4815.220].

IX.5. LOCKING SCREW Ø7.3 INSERTION


Insert Kirschner wire 2.0 [40.4815.220]; determine the screw length using the Screw length measure [40.5675.100].

Locking screw Ø7.3 insertion

RemovetheGuidesleeve.Insert the Locking screw Ø7.3 using the Torque wrench [40.5270.400] and relevant cannulated screwdriver tip.

Note:

* Remove the Inner sleeve 5.0/2.0 [40.5654.120] and read the value using the Screw length me-asure [40.5675.100].

** Subtract 5mm from the measured value if the sleeve 5.0/2.0 [40.5654.120] is not removed



SURGICAL TECHNIQUE


NOTE:

use the Cannulated drill with scale 5.0/2.2/220 [40.5652.220]

If the bone is very hard, use the Cannulated drill with scale 5,0/2,2/220 [40.5652.220].DrillusingtheGuidesleeve9.0/5.0[40.5654.150] that was used for Kirchner wire 2.0 [40.4815.220] insertion.

Postoperative treatment after locking plates does not differ from treatment after conventional stabilization.

X. POSTOPERATIVE TREATMENT

XI. IMPLANT REMOVAL

Inordertoremovethescrews,firstunlockalllockingscrewsfromtheplate.Thenremovebonescrews.Thispreventstherotationof the platewhile removing the last locking screw.

INSTRUCTIONS FOR USEImportant product information for

LOCKING PLATES AND SCREWS

STERILE R

NON

STERILE PURPOSE AND INDICATIONS

Locking Plates Systems are intended for surgical treatment of diaphysis and epiphysis fractures and for arthrodesis. Indications for implantation:

-comminuted fracture, - transverse fracture, -spiral fracture, -compression fractures, -delayed union of fractures.

Lockingd Plates are to be implanted with speci� ed screws which are listed in ChM Ltd Product Catalogue. ChM Ltd does not recommend any speci� c treatment method for particular patient.

CONTRAINDICATIONS• Infection or in� ammation in the operative site.• Suspected or documented allergy or intolerance to implant materials. When material sensitivity is suspected, testing is to be

completed before implant insertion. • Blood supply limitation in fracture site or in operative site. • Any patient having inadequate tissue coverage of the operative site.• Insu� cient bone quality (caused by illness, infection or prior implantation) not providing proper implant mounting/stabilization.• Morbid obesity (according to the W.H.O. standards) – would cause implant or � xation failure. • Neuromuscular disorder which would create unacceptable risk of � xation failure or complications in postoperative care.• Any other condition which would preclude the potential bene� t of implant usage and disturb the normal process of bone remod-

eling, e.g. the presence of tumors or congenital abnormalities, elevated ESR or high CRP unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC di� erential count.

• Any patient unwilling to cooperate with postoperative instructions; mental illness, a condition of senility or substance abuse may cause the patient to ignore certain necessary limitations and precautions in the implant usage.

• Patients with a known hereditary or acquired bone friability or calci� cation problem should not be considered for this type of sur-gery.

• Any case where the implant components selected for use would be too large or too small to achieve a successful result. • Any situation in which the implant usage would interfere with the anatomical structures or physiological performance.• Any situation in which the implant usage should be considered (eg pregnancy).• Any other medical conditions which exclude the potential bene� ts of surgery.• Situation which acc. to the physician assessment there is any contraindication for metal implant � xation.

The above list is not exhaustive.ADVERSE EFFECTS

The adverse e� ects may necessitate reoperation or revision. The surgeon should warn the patient about possibil-ity of adverse e� ects occurrence.

Potential adverse events include but are not limited to:• Infection and other adverse in� ammatory reactions. • Late bone fusion, non union or pseudoarthrosis. • Loss of anatomic position with nonunion or abnormal adhesion of bone with rotation or angle change. • Implant loosening, bending, breaking.• Loss of stability due to non-union, osteoporosis or instable complex fractures.• Implant migration.• Implant compressing the surrounding tissue or organs.• Reaction to implants as foreign bodies, e.g. the possibility of tumor metaplasia, developing autoimmune disease and/or scarring.• Loss of proper curvature and length of bone.• Bone fractures or “stress shielding” phenomenon causing loss of bone above, below or at the operative site. • Haemorrhage of blood vessels and / or hematomas.• Deep vein thrombosis, thrombophlebitis or pulmonary embolism.• Complications in donor site area.• Early or late loosening, or displacement of the implant.• Scar formation that could cause neurological impairment, or nerves compression and/or pain.• Respiratory complications such as pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.• Mental condition changes.• Limitations of the normal, everyday activities.• Death.

WARNINGSThe important medical information given in this document should be conveyed to the patient.The selection of proper shape and size of the implant for each patient is crucial to the success of the surgery. The surgeon is

responsible for selecting proper size. Preoperative and operating procedures, including knowledge of surgical techniques, prop-er fracture reduction, and correct selection and placement of the implants are important and shall be considered by surgeon in order to achieve the successful utilization of the system.

A successful result is not always achieved in every surgical case. This principle applies especially to cases where other factors related to the patient’s condition may prevent from achieving desired results.

Moreover, it is crucial to the success of the surgery if patient follows instruction given by physician. Patients who smoke have been shown to have a reduced incidence of bone fusion. These patients should be adequately advised of this fact and warned of this consequence.

The implants are intended as a guide to healing process and are NOT intended to replace normal body structure or bear the weight of the body. In such event or in case of delayed union or nonunion in the load or weight bearing might eventually cause the implant bending, loosening, disassembling or fatigue breaking.

No implant can withstand body loads without the support of bone. No implant can withstand body loads without the support of bone.

All metal surgical implants are subjected to repeated stresses, which can result in material fatigue and failure of the implant. The surgeon should inform the patient that the device cannot and does not restore � exibility, strength, reliability and durabil-ity of normal, healthy bones.

Overweight may cause in implant additional stresses and strains which can lead to fatigue and deformation or in conse-quence failure of the implant.

The implant may break or become damaged as a result of strenuous activity or trauma, and the device may need to be replaced. To avoid excessive stress on the implant, which could lead to non-union or implant failure and clinical problems, the surgeon shall instruct the patient about the physical activity limitations during the formation and maturation of bony mass.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walk-ing, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause implant failure.

It is essential to ensure that the desired shape of the implant is reached in as few bends as possible because titanium hard-ness increases and ductility (bendability) decreases. Excessive bending can lead to postoperative fracture of the plate. Due to po-tential risk for postoperative implant breakage, extremely acute angles together with small bending radii must be avoided. If Implant damages (indentations, elongated screw holes, etc.) occur, plate is to be exchanged for new one, more carefully bent one. Elongated screw holes do not provide accurate � t of the screw head to the plate. Plate segments must not be implanted into other patient.

While inserting the screw, it is essential to set correctly the screwdriver. Screwdriver should be set in the screw axis and prop-er axial pressure shall be applied to ensure the screwdriver recessing in the head of the bone screw as possible. Sensitive tight-ening of the screw must be exercised in the case of nonlocking screws without using a torque wrench. Given instruction reduces the risk of mechanical damage to the screw, screwdriver, or bony hole.PRODUCT DESCRIPTION1. Additional identi� cation system for the plates and screws has been introduced. On the surfaces of steel and titanium plates

additional feature „System e.g. 4.0, 4.5, 5.0, 7.0.” has been placed. Additional information help to state that particular screw (head diameter 4.0, 4.5, 5.0, 7.0.) cooperates with particular plate. Additionally, plate and screws included in the system,

made of titanium, are color coded: System 4.0 - green, System 4.5 - gold, System 5.0 – brown, System 7.0 - blue.2. Implants are single-use devices, provided sterile or non-sterile. 3. Not labeled implants are non-sterile.4. Package of each components should be intact at the time of receipt.5. The unit package contains:

a) Sterile device one piece of the product in sterile condition.b) Non-sterile device one piece of the product. Clear plastic bags are typical packaging material.

6. A sterile indicator is put on the sterile package.7. The label attached to the product shall include the following information:

a) Sterile product:- manufacturer’s logo: ChM; trade- mark: ChLP system,- name and size of the product,- batch code (LOT), for example, „0900000”,- STERILE sign: indicates sterilized product,- Sterilization batch number S-00000,- expiration date and sterilization method,- catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1.4034.503/1-implantable steel,

3.4034.503/3-titanium).b) Non-Sterile product:

- manufacturer’s logo: ChM; trade-mark: ChLP system,- name and size of the product,- batch code (LOT), for example, „0900000”,- NON-STERILE sign: indicates non-sterilized product,- catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1.4034.503/1- implantable steel,

3.4034.503/3-titanium).8. Additionally the package contains: instruction for use and labels placed in a patient’s medical record.9. Depending on the size or type of plate, the following information may be marked on its surface:

-manufacturer’s logo: ChM, -system „System 4.0, 4.5, 5.0, 7.0” (see paragraph 1. PRODUCT DESCRIPTION), -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g.„1.3155.506” (� rst digit indicates the material type e.g. 1.4034.503/1- implantable steel, 3.4034.503/3-titanium), - type of material is indicated: S – implantable steel, T – titanium, -number of holes e.g. „6 holes”.

10. Depending on the size or type of screw, the following information may be marked on its surface: -manufacturer’s logo: ChM, -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g.„1.3155.506” (� rst digit indicates the material type e.g. 1.4034.503/1-steel, 3.4034.503/3-ti-tanium), - type of material is indicated: S – steel, T – titanium.

• Only screws produced by ChM Ltd. (marked ChM) shall be used to lock the plate. Surgeon takes responsibility for using screws produced by other companies.

• Bending the plates in order to match the bone anatomy can be performed only with aid of instruments intended for this purpose. • Only instruments produced by ChM ltd. shall be use for insertion and removal of ChM implants. Inraoperative fracture or break-

ing of instruments has been occasionally reported. Instruments, which have experienced extensive use or excessive force, are sus-ceptible to fracture. ChM Ltd. recommends that all instruments be regularly inspected for wear and dis� gurement.

PRODUCT MATERIAL -plates and screws made of implantable steel according to ISO 5832/1, 5832/9 standards.

Alloy (content in %) – max valuesCr Ni Cu Mo C Si

22,0 15,0 0,5 3,0 0,08 1,0Mn P S N Nb Fe4,25 0,025 0,01 0,5 0,8 rest

-plates made of titanium according to 5832/2 standard. Chemicall (content in %) – max values

N C H Fe O Ti0,05 0,10 0,0125 0,40 0,40 rest

-screws made of titanium alloy according to 5832/2, 5832/11 standards.Alloy (content in %) – max values

Al Fe C N O6,75 0,3 0,08 0,05 0.2

H V Nb Ta Ti0,015 4,5 7,5 0,5 rest

• The implanted set shall be materially compatible (titanium implants shall not be mixed with other implants made of steel or any other metals).

• The type of the material is marked on device surface and/or on the product’s label).Magnetic Resonance Compatibility:

• for implants made of steel it is prohibited to carry out magnetic resonance imaging (MRI),• for implants made of titanium or its alloys, due to its non-ferromagnetic feature and poor electrical and thermal con-

ductivity, there is no contraindications for carrying out magnetic resonance imaging (MRI), using magnetic � eld strength of maximum 3 Tesla. However, the user should be absolutely familiar with the contraindications and warnings established by manufac-

turer of the MRI scanner which is to be used. PRE-OPERATIVE RECOMMENDATION1. Only patients that meet the criteria described in the INDICATIONS should be selected.2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoid-

ed.3. Before deciding about implantation, the surgeon shall inform the patient about indications and contraindications of such

procedure and possibility of complications after the operations. Patient shall be introduced to the purpose and manner of procedure, and to functional and esthetic e� ects of such treatment. Proper clinical diagnosis and accurate operation plan-ning and performance, are needed to achieve a good � nal result of treatment.

4. Each implant shall be stored in separate protective package. The package shall not be opened until starting procedure. 5. Do not use the implant if the sterile packaging is intact. Sterility cannot be guaranteed if package is intact. The package shall

be carefully verify before using.6. The implantation shall be carried out by the surgeon familiar and experienced with adequate operating techniques and hav-

ing undergone the necessary speci� c training in use of instruments produced by ChM Ltd. Surgical technique adequate for speci� c patient shall be chosen by surgeon.

7. The operation procedure shall be carefully planned. The size of implant should be determined prior to beginning the sur-gery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.

8. Unless supplied sterile, all implants should be cleaned and sterilized before use. Additional sterile components should be available in case of any unexpected need. Before surgery, the surgeon should ascertain that all implants and instruments are sterilized.

9. Before procedure, all components including instruments should be carefully checked to ensure that there is no damage on implant surface. Any damaged implant (surface damages, shape deformations) shall not be used.

10. The surgeon should be familiar with each element before using and should personally verify all needed devices before the surgery.

11. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. Alloying elements of implant material, are presented in section IMPLANT MATERIAL.

RECOMMENDATIONS FOR IMPLANT PROVIDED STERILE Sterile implant - is delivered in sterile package, with the inscription: “STERILE”. Such product is sterile and the manufacturer

is responsible for the process of sterilization. Products have been exposed to a minimum of 25kGy of gamma radiation process.

XII. INSTRUCTIONS FOR USE



INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USEImportant product information for

LOCKING PLATES AND SCREWS

STERILE R

NON

STERILE PURPOSE AND INDICATIONS

Locking Plates Systems are intended for surgical treatment of diaphysis and epiphysis fractures and for arthrodesis. Indications for implantation:

-comminuted fracture, - transverse fracture, -spiral fracture, -compression fractures, -delayed union of fractures.

Lockingd Plates are to be implanted with speci� ed screws which are listed in ChM Ltd Product Catalogue. ChM Ltd does not recommend any speci� c treatment method for particular patient.

CONTRAINDICATIONS• Infection or in� ammation in the operative site.• Suspected or documented allergy or intolerance to implant materials. When material sensitivity is suspected, testing is to be

completed before implant insertion. • Blood supply limitation in fracture site or in operative site. • Any patient having inadequate tissue coverage of the operative site.• Insu� cient bone quality (caused by illness, infection or prior implantation) not providing proper implant mounting/stabilization.• Morbid obesity (according to the W.H.O. standards) – would cause implant or � xation failure. • Neuromuscular disorder which would create unacceptable risk of � xation failure or complications in postoperative care.• Any other condition which would preclude the potential bene� t of implant usage and disturb the normal process of bone remod-

eling, e.g. the presence of tumors or congenital abnormalities, elevated ESR or high CRP unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC di� erential count.

• Any patient unwilling to cooperate with postoperative instructions; mental illness, a condition of senility or substance abuse may cause the patient to ignore certain necessary limitations and precautions in the implant usage.

• Patients with a known hereditary or acquired bone friability or calci� cation problem should not be considered for this type of sur-gery.

• Any case where the implant components selected for use would be too large or too small to achieve a successful result. • Any situation in which the implant usage would interfere with the anatomical structures or physiological performance.• Any situation in which the implant usage should be considered (eg pregnancy).• Any other medical conditions which exclude the potential bene� ts of surgery.• Situation which acc. to the physician assessment there is any contraindication for metal implant � xation.

The above list is not exhaustive.ADVERSE EFFECTS

The adverse e� ects may necessitate reoperation or revision. The surgeon should warn the patient about possibil-ity of adverse e� ects occurrence.

Potential adverse events include but are not limited to:• Infection and other adverse in� ammatory reactions. • Late bone fusion, non union or pseudoarthrosis. • Loss of anatomic position with nonunion or abnormal adhesion of bone with rotation or angle change. • Implant loosening, bending, breaking.• Loss of stability due to non-union, osteoporosis or instable complex fractures.• Implant migration.• Implant compressing the surrounding tissue or organs.• Reaction to implants as foreign bodies, e.g. the possibility of tumor metaplasia, developing autoimmune disease and/or scarring.• Loss of proper curvature and length of bone.• Bone fractures or “stress shielding” phenomenon causing loss of bone above, below or at the operative site. • Haemorrhage of blood vessels and / or hematomas.• Deep vein thrombosis, thrombophlebitis or pulmonary embolism.• Complications in donor site area.• Early or late loosening, or displacement of the implant.• Scar formation that could cause neurological impairment, or nerves compression and/or pain.• Respiratory complications such as pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.• Mental condition changes.• Limitations of the normal, everyday activities.• Death.

WARNINGSThe important medical information given in this document should be conveyed to the patient.The selection of proper shape and size of the implant for each patient is crucial to the success of the surgery. The surgeon is

responsible for selecting proper size. Preoperative and operating procedures, including knowledge of surgical techniques, prop-er fracture reduction, and correct selection and placement of the implants are important and shall be considered by surgeon in order to achieve the successful utilization of the system.

A successful result is not always achieved in every surgical case. This principle applies especially to cases where other factors related to the patient’s condition may prevent from achieving desired results.

Moreover, it is crucial to the success of the surgery if patient follows instruction given by physician. Patients who smoke have been shown to have a reduced incidence of bone fusion. These patients should be adequately advised of this fact and warned of this consequence.

The implants are intended as a guide to healing process and are NOT intended to replace normal body structure or bear the weight of the body. In such event or in case of delayed union or nonunion in the load or weight bearing might eventually cause the implant bending, loosening, disassembling or fatigue breaking.

No implant can withstand body loads without the support of bone. No implant can withstand body loads without the support of bone.

All metal surgical implants are subjected to repeated stresses, which can result in material fatigue and failure of the implant. The surgeon should inform the patient that the device cannot and does not restore � exibility, strength, reliability and durabil-ity of normal, healthy bones.

Overweight may cause in implant additional stresses and strains which can lead to fatigue and deformation or in conse-quence failure of the implant.

The implant may break or become damaged as a result of strenuous activity or trauma, and the device may need to be replaced. To avoid excessive stress on the implant, which could lead to non-union or implant failure and clinical problems, the surgeon shall instruct the patient about the physical activity limitations during the formation and maturation of bony mass.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walk-ing, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause implant failure.

It is essential to ensure that the desired shape of the implant is reached in as few bends as possible because titanium hard-ness increases and ductility (bendability) decreases. Excessive bending can lead to postoperative fracture of the plate. Due to po-tential risk for postoperative implant breakage, extremely acute angles together with small bending radii must be avoided. If Implant damages (indentations, elongated screw holes, etc.) occur, plate is to be exchanged for new one, more carefully bent one. Elongated screw holes do not provide accurate � t of the screw head to the plate. Plate segments must not be implanted into other patient.

While inserting the screw, it is essential to set correctly the screwdriver. Screwdriver should be set in the screw axis and prop-er axial pressure shall be applied to ensure the screwdriver recessing in the head of the bone screw as possible. Sensitive tight-ening of the screw must be exercised in the case of nonlocking screws without using a torque wrench. Given instruction reduces the risk of mechanical damage to the screw, screwdriver, or bony hole.PRODUCT DESCRIPTION1. Additional identi� cation system for the plates and screws has been introduced. On the surfaces of steel and titanium plates

additional feature „System e.g. 4.0, 4.5, 5.0, 7.0.” has been placed. Additional information help to state that particular screw (head diameter 4.0, 4.5, 5.0, 7.0.) cooperates with particular plate. Additionally, plate and screws included in the system,

made of titanium, are color coded: System 4.0 - green, System 4.5 - gold, System 5.0 – brown, System 7.0 - blue.2. Implants are single-use devices, provided sterile or non-sterile. 3. Not labeled implants are non-sterile.4. Package of each components should be intact at the time of receipt.5. The unit package contains:

a) Sterile device one piece of the product in sterile condition.b) Non-sterile device one piece of the product. Clear plastic bags are typical packaging material.

6. A sterile indicator is put on the sterile package.7. The label attached to the product shall include the following information:

a) Sterile product: - manufacturer’s logo: ChM; trade- mark: ChLP system, - name and size of the product, - batch code (LOT), for example, „0900000”, - STERILE sign: indicates sterilized product, - Sterilization batch number S-00000, - expiration date and sterilization method, - catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1.4034.503/1-implantable steel, 3.4034.503/3-titanium).

b) Non-Sterile product: - manufacturer’s logo: ChM; trade-mark: ChLP system, - name and size of the product, - batch code (LOT), for example, „0900000”, - NON-STERILE sign: indicates non-sterilized product, - catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1.4034.503/1- implantable steel, 3.4034.503/3-titanium).

8. Additionally the package contains: instruction for use and labels placed in a patient’s medical record.9. Depending on the size or type of plate, the following information may be marked on its surface:

-manufacturer’s logo: ChM, -system „System 4.0, 4.5, 5.0, 7.0” (see paragraph 1. PRODUCT DESCRIPTION), -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g.„1.3155.506” (� rst digit indicates the material type e.g. 1.4034.503/1- implantable steel, 3.4034.503/3-titanium), - type of material is indicated: S – implantable steel, T – titanium, -number of holes e.g. „6 holes”.

10. Depending on the size or type of screw, the following information may be marked on its surface: -manufacturer’s logo: ChM, -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g.„1.3155.506” (� rst digit indicates the material type e.g. 1.4034.503/1-steel, 3.4034.503/3-ti-tanium), - type of material is indicated: S – steel, T – titanium.

• Only screws produced by ChM Ltd. (marked ChM) shall be used to lock the plate. Surgeon takes responsibility for using screws produced by other companies.

• Bending the plates in order to match the bone anatomy can be performed only with aid of instruments intended for this purpose. • Only instruments produced by ChM ltd. shall be use for insertion and removal of ChM implants. Inraoperative fracture or break-

ing of instruments has been occasionally reported. Instruments, which have experienced extensive use or excessive force, are sus-ceptible to fracture. ChM Ltd. recommends that all instruments be regularly inspected for wear and dis� gurement.

PRODUCT MATERIAL -plates and screws made of implantable steel according to ISO 5832/1, 5832/9 standards.

Alloy (content in %) – max valuesCr Ni Cu Mo C Si

22,0 15,0 0,5 3,0 0,08 1,0Mn P S N Nb Fe4,25 0,025 0,01 0,5 0,8 rest

-plates made of titanium according to 5832/2 standard. Chemicall (content in %) – max values

N C H Fe O Ti0,05 0,10 0,0125 0,40 0,40 rest

-screws made of titanium alloy according to 5832/2, 5832/11 standards.Alloy (content in %) – max values

Al Fe C N O6,75 0,3 0,08 0,05 0.2

H V Nb Ta Ti0,015 4,5 7,5 0,5 rest

• The implanted set shall be materially compatible (titanium implants shall not be mixed with other implants made of steel or any other metals).

• The type of the material is marked on device surface and/or on the product’s label).Magnetic Resonance Compatibility:

• for implants made of steel it is prohibited to carry out magnetic resonance imaging (MRI),• for implants made of titanium or its alloys, due to its non-ferromagnetic feature and poor electrical and thermal con-

ductivity, there is no contraindications for carrying out magnetic resonance imaging (MRI), using magnetic � eld strength of maximum 3 Tesla. However, the user should be absolutely familiar with the contraindications and warnings established by manufac-

turer of the MRI scanner which is to be used. PRE-OPERATIVE RECOMMENDATION1. Only patients that meet the criteria described in the INDICATIONS should be selected.2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoid-

ed.3. Before deciding about implantation, the surgeon shall inform the patient about indications and contraindications of such

procedure and possibility of complications after the operations. Patient shall be introduced to the purpose and manner of procedure, and to functional and esthetic e� ects of such treatment. Proper clinical diagnosis and accurate operation plan-ning and performance, are needed to achieve a good � nal result of treatment.

4. Each implant shall be stored in separate protective package. The package shall not be opened until starting procedure. 5. Do not use the implant if the sterile packaging is intact. Sterility cannot be guaranteed if package is intact. The package shall

be carefully verify before using.6. The implantation shall be carried out by the surgeon familiar and experienced with adequate operating techniques and hav-

ing undergone the necessary speci� c training in use of instruments produced by ChM Ltd. Surgical technique adequate for speci� c patient shall be chosen by surgeon.

7. The operation procedure shall be carefully planned. The size of implant should be determined prior to beginning the sur-gery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.

8. Unless supplied sterile, all implants should be cleaned and sterilized before use. Additional sterile components should be available in case of any unexpected need. Before surgery, the surgeon should ascertain that all implants and instruments are sterilized.

9. Before procedure, all components including instruments should be carefully checked to ensure that there is no damage on implant surface. Any damaged implant (surface damages, shape deformations) shall not be used.

10. The surgeon should be familiar with each element before using and should personally verify all needed devices before the surgery.

11. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. Alloying elements of implant material, are presented in section IMPLANT MATERIAL.

RECOMMENDATIONS FOR IMPLANT PROVIDED STERILE Sterile implant - is delivered in sterile package, with the inscription: “STERILE”. Such product is sterile and the manufacturer

is responsible for the process of sterilization. Products have been exposed to a minimum of 25kGy of gamma radiation process.

XII. INSTRUCTIONS FOR USE



INSTRUCTIONS FOR USE

SYMBOL TRANSLATION • OBJAŚNIENIA SYMBOLI • ПОЯСНЕНИЕ ОБОЗНАЧЕНИЙ • EXPLICACIÓN DE LOS SÍMBOLOSDo not reuse

Nie używać powtórnieНе использовать повторно

No reutilizar

Do not resterilizeNie sterylizować ponownie

Не стерилизовать повторноNo reesterilizar

CautionOstrzeżenie

ПредупреждениеAdvertencia

Sterylized using irradiationSterylizowany przez napromieniowanie

Стерилизация облучениемEsterilizado mediante radiación

Sterylized using ethylene oxideSterylizowany tlenkiem etylenuСтерилизация окисью этилена

Esterilizado mediante óxido de etileno

Non-sterileNiesterylny

НестерильноNo estéril

STERILE R STERILE EO NONSTERILE

Batch codeKod partii

Код партииCódigo de lote

Catalogue numberNumer katalogowyНомер по каталогуNúmero de catálogo

Consult instruction for useZajrzyj do instrukcji używania

Смотри инструкцию по применениюConsultar instrucciones de uso

LOT REF

MaterialMateriał

МатериалMaterial

QuantityIlość

КоличествоCantidad

Use byUżyć do

Срок годностиFecha de caducidad

Mat: Qty:

Before using of the sterile product, the following rules must be applied:a) Check out the expiration date of sterilization.

Do not use the devices with overstepped sterility date.b) Check out if the sterile package is not opened and damaged.

Do not use the devices if sterile package is intact.c) Check out if sterility indicator on the sterile packaging is red, which indicates that radiation sterilization of the product

was performed.Do not use devices when the sterility indicator is other than red.

RECOMMENDATIONS FOR IMPLANTS PROVIDED NON-STERILEBefore using of the non-sterile product, the following rules must be applied:The device must undergo cleaning, disinfecting and sterilization procedures. It is recommended to use an automated proce-

dure (washer-disinfector) for cleaning and disinfecting. Implant cannot be sterilized in the package, in which was delivered. Patient’s labels shall be protected from loss or destruction during process of cleaning and sterilization. These rules of cleaning and sterilization should be followed for all devices planned to be inserted. Instruments used for im-

plantation shall undergone cleaning and sterilization procedure. Preparation for cleaningRemove possible surface contamination using a disposable cloth, paper towel or plastic brushes (nylon brushes are recom-mended). Do not use brushes made of metal, bristles or materials which can cause implant failure. Cleaning and disinfecting processChosen washing and disinfecting detergents must be suitable and approved for use with medical devices. It is important to follow the instructions and restrictions speci� ed by the producer of those detergent. It is recommended to use water solu-tions of cleaning-disinfection agents with a neutral pH.Manual cleaning

• Brushing carefully apply washing detergent (e.g. MEDICLEAN) to implant surfaces. A suitable brush must be used for clean-ing holes.

• If applicable, ultrasonic cleaning may be performed. The ultrasonic bath must be prepared according to the manufactur-er’s instructions.

• Next rinse thoroughly under � owing water. It is recommended to use demineralized water.• Visually inspect the entire surface of the device for damages and contaminants. Damaged implants must be removed.

For contaminated implants, the cleaning process should be repeated.Cleaning with washer-disinfectorThe device should undergo a process of machine washing in the washer-disinfector (use washing-disinfecting agents recom-mended for medical devices). Procedure of washing with the washer-disinfector shall be performed according to hospital procedures, recommendations of the washing machine manufacturer, and instructions for use prepared by manufacturer of washing and disinfection agents.Disinfection should be carried out at 93°C (soak for 10 minutes in demineralized water) without the use of detergents.DryingDrying must be performed as part of the cleaning/ disinfection process.SterilizationDisinfected, washed, and dried device shall undergo the sterilization process in accordance with the obligatory client proce-dures. The recommended method of sterilization is steam sterilization (in water vapor) under overpressure:

- temperature: 134°C, -pressure: 2 atm. of pressure above atmospheric (overpressure), -minimum exposure time: 15 min, -minimum drying time: 20 min.CAUTION:

-Sterilization must be e� ective and in accordance with requirements of the EN 556 standard, which states, that theoretical prob-ability of living microorganism presence is less than 1/106 (SAL=10-6, where SAL stands for Sterility Assurance Level). - Implant must not be sterilized in the package in which was delivered.

RE-STERILIZATIONATTENTION: The user of the product bears all responsibility for re-sterilization. In such case the device shall be cleaned and sterilized in way described in chapter RECOMMENDATIONS FOR IMPLANTS

PROVIDED NON-STERILE.PRECAUTIONS1. Implant is intended for single use only. After removing the implant from the patient’s body it must not be re-used. Final dis-

posal of implant shall be carried in accordance with current hospital procedures.2. Never, under any circumstances, reuse or reimplant devices. Even when a removed, reused device appears undamaged,

it may have small latent defects or internal stress patterns that leads to early breakage.3. Implant, which had contact with tissues and body � uids of the other patient cannot be re-implanted.4. Avoid damaging implant surface and the deformation of implant shape during the implantation, the damaged implant can-

not be left or implanted in the patient’s body. 5. Slippage or misuse of instruments or implants may cause injury to the patient or operative personnel.6. Insertion, removal and adjustment of implants must only be done with instruments specially designated for those implants,

and manufactured by ChM. Ltd. Usage of ChM’s implants and instruments in combination with implants and instruments from other manufactur-ers may cause damage or failure of those implants or instruments and may lead to improper course of surgery and healing process.

7. Intraoperative fracture or breaking of instruments has been occasionally reported. Instruments, which have experienced ex-tensive use or excessive force, are susceptible to fracture. It is recommends to inspect all instruments for wear and dis� gure-ment. Instruments should be examined for wear or damaged prior to surgery.

POST-OPERATIVE RECOMMENDATIONIt is essential to follow all physician’s postoperative directions and warnings.

1. It is essential to con� rm proper position of the implant by roentgenographic examination.2. In postoperative period, an immobilization of union should be con� rmed by roentgenographic examination. If non-union

occurres or if any components loosen, migrate, and/or break, the devices should be revised and/or removed immediately to avoid serious injury.

3. Surgeons must instruct patients regarding appropriate and restricted activities during consolidation and maturation for the fusion mass in order to prevent placing excessive stress on the implants which may lead to � xation or implant fail-ure accompanying clinical problems. The implant can break or become damaged as a result of strenuous activity or trauma, and the device may need to be replaced in the future.

4. If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walk-ing, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause failure of the device.

5. The patient should be warned about the risk of not following the rules above, or being unavailable for follow-up exami-nation.

6. Surgeon must instruct patient to report any unusual changes of the operative site to his/her physician. The physician should closely monitor the patient if any change at the site has been detected.

7. The patient should be informed about type of implant material (titanium or titanium alloy). 8. The patient should be advised not to smoke or consume excess alcohol, during period of the bone fusion process.CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING

Steel implant shall be removed after period of not more than two years after its implantation.When bone union is achieved, the implants serve no functional purpose and may be removed. The possibility of another sur-

gical procedure and associated risks must be analyzed and discussed with the patient. The � nal decision on implant removal is up to the surgeon. In most patients, removal is indicated because the implants are not intended to transfer forces developed during normal activities.

If the device is not removed following completion of its intended use, one or more complications may occur, in particular:1. Corrosion, with localized tissue reaction or pain.2. Migration of the implant, possibly resulting in injury.3. Risk of additional injury from postoperative trauma.4. Bending, loosening and breakage, which could make removal impractical or di cult.5. Pain, discomfort, or abnormal sensations due to the presence of the device.6. Possible increased risk of infection.7. Bone loss due to stress shielding.8. Potential unknown and/or unexpected long term e� ects.

Implant removal should be followed by adequate postoperative management to avoid fracture, re-fracture, or other com-plications.

If this instruction appears unclear, please contact the manufacturer, who shall provide all required explanation.Updated INSTRUCTIONS FOR USE are available at the following website: www.chm.eu.

U/NS/R-010/12; Date of veri� cation: November 2012

REUSABLE ORTHOPAEDIC AND SURGICAL INSTRUMENTS

Instruments manufactured by ChM Ltd. are made of stainless steel, aluminium alloys and plastics according to ISO standards. Each medical instrument is exposed to occurrence of corrosion, stains and damage, if not treated with special care and recommendations below.

1. MaterialsDevices are produced of corrosion-resistant steels. The protective layer (passive layer) against corrosion is formed on the surface of the stain-less steel due to high content of chromium.Devices produced of aluminium are mainly stands, palettes, cuvettes and some parts of instruments such as handles of screwdriver, awl or wrench, etc. The protective oxide layer, which may be dyed or stay in natural colour (silvery-grey), is formed on the aluminium as an effect of electrochemical surface treatment on its surface. Devices made of aluminium with processed layer have a good corrosion resistance. The contact with strong alkaline cleaning and disinfecting agents, solutions containing iodine or some metal salts due to chemical interference on the processed aluminium surface shall be avoided.Devices are mainly manufactured out of following plastics: POM-C (Polyoxymethylene Copolymer), PEEK (Polyetheretherketone) and teflon (PTFE). The above mentioned materials can be processed (washed, cleaned, sterilized) at temperatures not higher than 140°C, they are stable in aqueous solution of washing-disinfection with pH values from 4 to 9.5.

If the material of the device cannot be specified, please contact ChM Ltd. company representative.

2. Disinfection and cleaningEffective cleaning is a complicated procedure depending on the following factors: the quality of water, the type and the quality of used deter-gent, the technique of cleaning (manual/machine), the correct rinsing and drying, the proper preparation of the instrument, the time, the tem-perature. Internal procedures of sterilizers, recommendations of cleaning and disinfection agents, as well as recommendations for cleaning and sterilizing automatic machines shall be observed.

Read and follow the instructions and restrictions specified by the manufactures of the agents used for disinfection and cleaning procedures.

1. Before the first use, the product has to be thoroughly washed in the warm water with washing-disinfecting detergent. It is important to follow the instructions and restrictions specified by the producer of those detergent. It is recommended to use water solutions of cleaning-disinfec-tion agents with a neutral pH.

2. After use, for at least 10 minutes the product has to be immediately soaked in an aqueous disinfectant solution of enzyme detergent with a netural pH (with a disinfection properties) normally used for reusable medical devices (remember to prevent drying out any organic re-mains on the product surface). Follow all the instructions specified by the producer of those enzyme detergents.

3. Carefully scrub/clean the surfaces and crevices of the product using a soft cloth without leaving threads, or brushes made of plastic, only the nylon brushes are recommended. Do not use brushes made of metal, bristles or damaging material as they can cause physical or chemical corrosion.

4. Next, thoroughly rinse the instrument under the warm running water, paying particular attention for carefully rinsing the slots. Use nylon brushes making multiple moves back and forth on the surface of the product. It is recommended to rinse in demineralized water, in order to avoid water stains and corrosion caused by chlorides, found in the ordinary water, and to avoid forming the stains on the surface such as anodized. During the rinsing manually remove the adherent remains.

5. Visually inspect the entire surface of the product to ensure that all contaminations are removed.

If there are any residues of human tissue or any other contamination, repeat all stages of the cleaning process.

6. Then, the instrument has to undergo a process of machine washing in the washer-disinfector (use washing-disinfecting agents recom-mended for reusable medical devices and instruments).

Procedure of washing with the washer-disinfector shall be performed according to internal hospital procedures, recommendations of the washing machine manufacturer, and instructions for use prepared by the washing-disinfection agents manufacturer.

3. SterilizationBefore each sterilization procedure and application, the device has to be controlled. The device is to be efficient, without toxic compounds as residues after disinfection and sterilization processes, without structure damages (cracks, fractures, bending, peeling). Remember that sterilization is not substitute for cleaning process!

Devices manufactured out of plastics (PEEK, PTFE, POM-C) may be sterilized by any other available sterilization method validated in the centre but the sterilization temperature is not to be higher than 140°C.

Sterilization of surgical instruments shall be carried out using equipment and under the conditions that conform to applicable standards. It is recommended to sterilize in steam sterilizers where sterilizing agent is water vapour. Recommended parameters of the sterilization method: temperature min. 134°C, pressure of 2 atm.

The above given parameters of sterilization are to be absolutely observed.

Validated sterilization methods are allowed. Durability and strength of instruments highly depend on their usage. Careful usage consistent with in-tended application of the product, prevents product damaging and prolongs its life.

SALES OFFICEtel.: + 48 85 713-13-30 ÷ 38fax: + 48 85 713-13-39

ChM Ltd.Lewickie 3b16-061 Juchnowiec K.Polandtel. +48 85 713-13-20fax +48 85 713-13-19e-mail: [email protected]

4 Intramedullary osteosynthesis of humerus 7 Intramedullary osteosynthesis of fibula and forearm 6 Intermedullary osteosynthesis of femur by trochanteric nails 8 Dynamic Hip (DSB)/ Condylar (DSK) stabilizer 9 Spine stabilization CHARSPINE 15 Tibial and femoral angular set block 20 Radial Head Prosthesis KPS 22 Locking plates 23 Intramedullary osteosynthesis of femur (reversed method) 40.3660 24 Intramedullary osteosynthesis of femur 40.5060.000 25 Intramedullary osteosynthesis of tibia 40.5370.500 28 Intramedullary osteosynthesis of femur by trochanteric nail - ChFN 29 Cervical locking plate system 30 Proximal humeral plate 31 Femoral plates 32 4.0 ChLP plates for distal part of radial bone 35 Spine stabilization [6mm] 36 ChLP screws removing 37 Stabilization of the pubic symphysis 38 Intramedullary tibia osteosynthesis with CHARFIX2 nails 40 Intervertebral cages BS PEEK CAGE

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