instruction - K2 MEDICAL IMPORT

IMPLANTS •INSTRUMENT SET •

SURGICAL TECHNIQUE •

instruction

LOCKING PLATES

0197ISO 9001ISO 13485

22E

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

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

II. PLATE SELECTION AND CONTOURING ............................................................................................................... 5

III. SYSTEM 5.0 ............................................................................................................................................................. 7III.1. Implants ....................................................................................................................................................... 7III.2. Instruments................................................................................................................................................ 27III.3. Indications ................................................................................................................................................. 29III.4. Surgical technique ..................................................................................................................................... 30

III.4.1. Temporary attachment of the plate ................................................................................................. 30

III.4.2. Locking screw 3.5 insertion ............................................................................................................ 31

III.4.3. Cortical screw 3.5 insertion ........................................................................................................... 34

IV. SYSTEM 7.0 ........................................................................................................................................................... 36IV.1. Implants ..................................................................................................................................................... 36IV.2. Instruments ............................................................................................................................................... 47IV.3. Indications ................................................................................................................................................. 49IV.4. Surgical technique ..................................................................................................................................... 50

IV.4.1. Temporary plate attachment ........................................................................................................... 50

IV.4.2. Locking screw 5.0 insertion ............................................................................................................ 51

IV.4.3. Cortical screw 5.0 insertion ............................................................................................................ 54

IV.4.4. Introduction of 7.3 Locked Screw ................................................................................................... 56

V. POSTOPERATIVE TREATMENT ........................................................................................................................... 57

VI. IMPLANT REMOVAL ............................................................................................................................................ 57

INSTRUCTIONS FOR USE ......................................................................................................................................... 58

Edition 22 of 04.05.2010, reviewed 02.07.2012

mailto://[email protected]



INTRODUCTION

I. INTRODUCTION

The main purpose of surgical treatment of bone fractures is to reconstruct the anatomical bone structure and to restore its func-tion. Internal stabilization with locking plates enables accurate fracture reduction, stable fi xation, blood fl ow preservation and functional activation of injured limb.

System ChLP consists of titanium plates and screws combining locking screws technique with conventional treatment techni-ques using plates. This system is the improvement of existing stabilization methods. Locking screws system enables angular fi xation using conventional surgical techniques. It is particularly indicated in:• multifragmental fractures;• nonunions or malunions;• osteopenia;• osteotomy stabilization;• when conventional screws applying is insuffi cient or does not bring expected effects.

Locking plates are provided with holes A for conventional cortical screws with or without compression and with threaded holes B for 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 conventional methods of fracture treatment using plates:• enable stable fi xation ensuring angular stabilization in fracture site;

• enable compression using conventional cortical and can-cellous screws, combination with conventional and locking screws is available;

• reduced bone-plate contact ensures better blood fl ow of pe-rimplant tissues;

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

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

Following instruction does not refer to particular fracture types as the locking plates system includes different plates that are relevant to many different fractures.

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

Division is based on the screw head diameter, however screws with different cortical thread diameter in one system range are available.

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

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

A B



INTRODUCTION

II. PLATE SELECTION AND CONTOURING

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 plates contouring. Advanced shaped plates do not require additional bending in most cases.

Note:If the plate bending is necessary, remember not to deform threaded holes excessively.The certain deformation degree is permitted, however it may affect locking efficiency and make difficulty with further locking screw insertion.

If the plate bending is required:• 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.


7

L

Nr katalogowy,Catalogue no., № по кат.

O L[mm] Tytan, Titanium, Титан

5 88 3.3157.5056 103 3.3157.5067 118 3.3157.5078 133 3.3157.50810 163 3.3157.51012 193 3.3157.512

O - liczba otworów gwintowanych w płytcenumber of threaded holes in the plateколичество резьбовых отверстий в пластине

dostępneavailableдоступные

4 - 18otworów · holes · отверстий

(73 mm · мм - 283 mm · мм)

11 2,8

5,0ChLP Płytka wąska, kompresyjna, z ograniczonym kontaktem5.0ChLP Narrow compression plate with limited contact5,0ChLP Пластина узкая компрессирующая с ограниченным контактом

Paleta na płytki 5,0ChLP - proste; Palette for 5.0ChLP plates - straight; Поддон для пластин 5,0ChLP - прямые

Lp.Nr katalogowy,Catalogue No.,

№ по кат.Nazwa Name Название

Szt.,Pcs,Шт.

1 40.5758.050 Paleta Palette Поддон 1

40.5

758.

550

2 12.0751.100 Kontener z litym dnem 1/2 306x272x85mm Container solid bottom 1/2 306x272x85mm Контейнер со сплошным дном 1/2

306x272x85мм 1

3 12.0751.200 Pokrywa aluminiowa perfor.1/2 306x272x15mm Szara

Perforated aluminum lid 1/2 306x272x15mm Gray

Алюминиевая перфорированнаяпокрышка 1/2 306x272x15мм Серая 1

bez implantów; implants not included; без имплантатов

Tytan, Titanium, Титан3.1283.010÷1103.1306.010÷110

Ø3,5


Ø3,5

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

III. SYSTEM 5.0

III.1. Implants

8

L

11

2,6



4 88 3.4022.5045 102 3.4022.5056 116 3.4022.5067 130 3.4022.5078 144 3.4022.50810 172 3.4022.510




(88 mm · мм - 340 mm · мм)

5,0ChLP Płytka rekonstrukcyjna prosta5.0ChLP Reconstruction straight plate5,0ChLP Пластина реконструктивная прямая

Paleta na płytki 5,0ChLP - rekonstrukcyjne; Palette for 5.0ChLP reconstruction plates; Поддон для блокируемых реконструктивных пластин 5.0ChLP



Szt.,Pcs,Шт.


40.5

758.

600


306x272x85мм 1






Ø3,5


Ø3,5


Ø3,5


Ø3,5


Ø3,5


IMPLANTS

9

5,0ChLP Płytka rekonstrukcyjna prosta wąska5.0ChLP Reconstruction straight plate narrow5,0ChLP Пластина реконструктивная прямая узкая

L

9

2,2



4 88 3.4080.5045 102 3.4080.5056 116 3.4080.5067 130 3.4080.5078 144 3.4080.50810 172 3.4080.510




(88 mm · мм - 340 mm · мм)


Ø3,5


Ø3,5


Ø2,4


Ø2,4


Ø2,4


IMPLANTS

10

5,0ChLP Płytka obojczykowa z hakiem5.0ChLP Clavicular hook plate 5,0ChLP Пластина ключичная с крючком

3,5

HNr katalogowy

Tytan

H O lewa prawa

12

5 3.4025.505 3.4026.5056 3.4025.506 3.4026.5067 3.4025.507 3.4026.5078 3.4025.508 3.4026.508

15

5 3.4027.505 3.4028.5056 3.4027.506 3.4028.5067 3.4027.507 3.4028.5078 3.4027.508 3.4028.508

18

5 3.4029.505 3.4030.5056 3.4029.506 3.4030.5067 3.4029.507 3.4030.5078 3.4029.508 3.4030.508

O - liczba otworów gwintowanych w płytce

LR

Tytan3.1283.010÷1103.1306.010÷110

Ø3,5

Tytan3.1289.012÷0953.5200.012÷095

Ø3,5

Tytan3.1289.012÷0953.5200.012÷095

Ø3,5


IMPLANTS

11

L

LR


Tytan, Titanium, Титан

O L[mm]

lewa, left, левая

prawa, right, правая

3 71 3.7015.503 3.7014.5034 80 3.7015.504 3.7014.5045 90 3.7015.505 3.7014.5056 99 3.7015.506 3.7014.5068 116 3.7015.508 3.7014.508

O - liczba otworów gwintowanych w części trzonowej płytkinumber of threaded holes in the shaft part of the plate количество резьбовых отверстий в диафизарной части пластины


3 - 11otworów · holes · отверстий(71 mm · мм - 143 mm · мм)

5,0ChLP Płytka obojczykowa S5.0ChLP Clavicle S plate 5,0ChLP пластина ключичная S-образная

Paleta na płytki 5,0ChLP - 3.7014/3.7015; Palette for 5.0ChLP plates - 3.7014/3.7015; Поддон для пластин 5,0ChLP - 3.7014/3.7015



Szt.,Pcs,Шт.


40.5

758.

630


306x272x85мм 1






Ø2,4


Ø3,5


Ø3,5


Ø3,5


IMPLANTS

12

5,0ChLP Płytki do pięty z zaczepem5.0ChLP Calcaneal plates with hook5,0ChLP Пластины для пятки с крючком

60

L R 1,3

85°

2,0

2,0

L R

60


Tytan, Titanium, Титанlewa, left,

леваяprawa, right,

правая3.4057.000 3.4058.000


Tytan, Titanium, Титанlewa, left,

леваяprawa, right,

правая3.4059.000 3.4060.000

5,0ChLP Płytka piętowa5.0ChLP Calcaneal plate5,0ChLP Пластина для пятки


Ø3,5


Ø3,5


IMPLANTS

13

⅓

L

13

2



4 45 3.4081.0045 57 3.4081.0056 69 3.4081.0067 81 3.4081.0078 93 3.4081.00810 117 3.4081.010




(33 mm · мм - 141 mm · мм)

5,0ChLP Płytka prosta rurkowa ⅓5.0ChLP Tubular straight plate ⅓ 5,0ChLP Трубчатая прямая пластина ⅓


Ø3,5


IMPLANTS

14

L

L R



O L[mm]



4 109 3.4011.504 3.4012.5045 124 3.4011.505 3.4012.5056 139 3.4011.506 3.4012.5068 169 3.4011.508 3.4012.508

O - liczba otworów gwintowanych w części trzonowej płytkinumber of threaded holes in the shaft part of the plateколичество резьбовых отверстий в диафизарной части пластины



5,0ChLP Płytka piszczelowa wąska5.0ChLP Narrow tibia plate5,0ChLP Узкая пластина для большеберцовой кости




Szt.,Pcs,Шт.


40.5

758.

520


306x272x85мм 1






Ø3,5


Ø3,5


Ø3,5


IMPLANTS

15

5,0ChLP Płytka ramienna5.0ChLP Humeral plate 5,0ChLP Пластина для плечевой кости

L



3 101 3.4034.5034 116 3.4034.5045 131 3.4034.5056 146 3.4034.5068 176 3.4034.508




Paleta na płytki 5,0ChLP - 3.4034; Palette for 5.0ChLP plates - 3.4034; Поддон для пластин 5,0ChLP - 3.4034



Szt.,Pcs,Шт.

1 40.5671.000 Nakładka celująca Aiming block Шаблон накладка 1

40.5

758.

010

40.5

758.

510

2 40.5672.000 Tuleja ochronna 7,0/5,0 Protective guide 7.0/5.0 Втулка защитная 7,0/5,0 2



306x272x85мм 1




bez implantów; z dodatkowymi narzędziamiimplants not included; with additional instrumentsбез имплантатов; с дополнительными инструментами


Ø3,5


Ø3,5


Ø3,5


IMPLANTS

16

LWzornik płytki 5,0ChLP - 3.4033.5xx5.0ChLP plate former - 3.4033.5xxШаблон пластины 5,0ChLP - 3.4033.5xx

Wyposażenie dodatkowe:Additional equipment:Дополнительное оснащение:

40.5394.501



7 167 3.4033.5079 197 3.4033.509


5,0ChLP Płytka piszczelowa dalsza przyśrodkowa5.0ChLP Medial distal tibial plate5,0ChLP Пластина большеберцовая дистальная медиальная

Paleta na płytki 5,0ChLP - 3.4033; Palette for 5.0ChLP plates - 3.4033; Поддон для пластин 5,0ChLP - 3.4033



Szt.,Pcs,Шт.


40.5

758.

560


306x272x85мм 1






Ø3,5


Ø3,5


Ø3,5


IMPLANTS

17

L

R L



O L[mm]



4 123 3.4039.504 3.4040.5046 153 3.4039.506 3.4040.5068 183 3.4039.508 3.4040.508




5,0ChLP Płytka piszczelowa dalsza przyśrodkowa5.0ChLP Tibial distal medial plate5,0ChLP Большеберцовая дистальная серединная пластина




Szt.,Pcs,Шт.

1 40.5726.100 Nakładka celująca [3.4039] Aiming block [3.4039] Шаблон накладка [3.4039] 1

40.5

758.

070

40.5

758.

5702 40.5726.200 Nakładka celująca [3.4040] Aiming block [3.4040] Шабдон накладка [3.4040] 1




306x272x85мм 1






Ø3,5


Ø3,5


Ø3,5


IMPLANTS

18

L R

L



O L[mm]



4 120 3.4051.504 3.4052.5046 150 3.4051.506 3.4052.5068 180 3.4051.508 3.4052.508




5,0ChLP Płytka piszczelowa dalsza L5.0ChLP Distal tibial L plate5,0ChLP Пластина большеберцовая дистальная L-образная




Szt.,Pcs,Шт.


40.5

758.

080

40.5

758.





306x272x85мм 1






Ø3,5


Ø3,5


Ø3,5


IMPLANTS

19

L

L R



O L[mm]



3 90 3.7029.503 3.7030.5034 105 3.7029.504 3.7030.5045 120 3.7029.505 3.7030.5056 135 3.7029.506 3.7030.5068 165 3.7029.508 3.7030.508




5,0ChLP Płytka strałkowa dalsza boczna5.0ChLP Distal lateral fi bula plate5,0ChLP Пластина для малоберцовой кости дистальная боковая


Ø3,5


Ø3,5


Ø2,4


IMPLANTS

20

L

L R



O L[mm]



3 89 3.7001.503 3.7000.5034 107 3.7001.504 3.7000.5045 121 3.7001.505 3.7000.5056 136 3.7001.506 3.7000.506


RL R

min

2 o

twor

ym

in 2

hol

esм

ин. 2

отв

ерст

ия

min

2 o

twor

ym

in 2

hol

esм

ин. 2

отв

ерст

ия

5,0ChLP Płytka ramienna dalsza przyśrodkowa 5.0ChLP Distal medial humeral plate 5,0ChLP Пластина для плечевой кости дистальная медиальная

Paleta na płytki 5,0ChLP - 3.7000-3.7003; Palette for 5.0ChLP plates - 3.7000-3.7003; Поддон для пластин 5,0ChLP - 3.7000-3.7003



Szt.,Pcs,Шт.


40.5

758.

110

40.5

758.

610







306x272x85мм 1






Ø2,4


Ø3,5


Ø3,5


IMPLANTS

21

LL R



O L[mm]



3 95 3.7003.503 3.7002.5034 109 3.7003.504 3.7002.5045 123 3.7003.505 3.7002.5056 137 3.7003.506 3.7002.506


min

2 o

twor

ym

in 2

hol

esм

ин. 2

отв

ерст

ия

min

2 o

twor

ym

in 2

hol

esм

ин. 2

отв

ерст

ия

5,0ChLP Płytka ramienna dalsza grzbietowo-boczna 5.0ChLP Distal dorso-lateral humeral plate5,0ChLP Пластина для плечевой кости дистальная дорсолатеральная

Paleta na płytki 5,0ChLP - 3.7000-3.7003; Palette for 5.0ChLP plates - 3.7000-3.7003; Поддон для пластин 5,0ChLP - 3.7000-3.7003



Szt.,Pcs,Шт.


40.5

758.

110

40.5

758.

610







306x272x85мм 1






Ø2,4


Ø3,5


Ø3,5


IMPLANTS

22

L

L RR

max 18mmмакс.18 мм

max 16mm, макс.18 ммmax 34mm, макс.34 мм

1

2



O L[mm]



2 88 3.4097.502 3.4098.5024 121 3.4097.504 3.4098.5046 151 3.4097.506 3.4098.5068 181 3.4097.508 3.4098.50810 210 3.4097.510 3.4098.510




5,0ChLP Płytka wyrostka łokciowego 5.0ChLP Olecranon plate 5,0ChLP Пластина для локтевого отростка




Szt.,Pcs,Шт.


40.5

758.

120

40.5

758.





306x272x85мм 1






Ø3,5


Ø3,5


Ø3,5


IMPLANTS

23

5,0ChLP Wkręt Ø3,55.0ChLP Screw Ø3.55,0ChLP Винт Ø3,5

L

Ø3,5

Ø rdzeniacoreстержень

2,8

Ø wiertło ze skalądrill with scaleсверло c измерительной шкалой

40.5653.220 2,8

tuleja prowadzącaguide sleeveвтулка направляющая

40.5673.028 5,0/2,8

grotscrewdriver tipнаконечник

40.5676.000 S2,5


40.5677.000 T15

gwintowniktapметчик

40.5661.000 3,5

samogwintującyself-tappingсамонарезающий


2,5 T15


L[mm] Tytan, Titanium, Титан12 3.1289.012 3.5200.01214 3.1289.014 3.5200.01416 3.1289.016 3.5200.01618 3.1289.018 3.5200.01820 3.1289.020 3.5200.02022 3.1289.022 3.5200.02224 3.1289.024 3.5200.02426 3.1289.026 3.5200.02628 3.1289.028 3.5200.02830 3.1289.030 3.5200.03032 3.1289.032 3.5200.03234 3.1289.034 3.5200.03436 3.1289.036 3.5200.03638 3.1289.038 3.5200.03840 3.1289.040 3.5200.04042 3.1289.042 3.5200.04244 3.1289.044 3.5200.04446 3.1289.046 3.5200.04648 3.1289.048 3.5200.04850 3.1289.050 3.5200.05052 3.1289.052 3.5200.05254 3.1289.054 3.5200.05456 3.1289.056 3.5200.05658 3.1289.058 3.5200.05860 3.1289.060 3.5200.06065 3.1289.065 3.5200.06570 3.1289.070 3.5200.07075 3.1289.075 3.5200.07580 3.1289.080 3.5200.08085 3.1289.085 3.5200.08590 3.1289.090 3.5200.09095 3.1289.095 3.5200.095

Ø5,0

5,0 ChLP Wkręt stożkowy Ø3,55,0 ChLP Conical screw Ø3.55,0 ChLP Винт конический Ø3,5

Ø3,5

L

Ø5,0



2,5 T15


L[mm] Tytan, Titanium, Титан30 3.1290.030 3.5205.03035 3.1290.035 3.5205.03540 3.1290.040 3.5205.04045 3.1290.045 3.5205.04550 3.1290.050 3.5205.05055 3.1290.055 3.5205.05560 3.1290.060 3.5205.06065 3.1290.065 3.5205.06570 3.1290.070 3.5205.07075 3.1290.075 3.5205.07580 3.1290.080 3.5205.08085 3.1290.085 3.5205.08590 3.1290.090 3.5205.090


IMPLANTS

24

2,5 T15



5,0ChLP Wkręt gąbczasty Ø3,95.0ChLP Cancellous screw Ø3,95,0ChLP Винт спонгиозный Ø3,9

L

Ørdzeniacoreстержень

2,5

Øwiertło ze skalądrill with scaleсверло c измерительной шкалой

40.5912.220 2,5


40.5673.025 2,5


40.5676.000 S2,5


40.5677.000 T15

Ø3,9

Ø5,0


4,5ChLP wkręt Ø2,44.5ChLP screw Ø2.44,5ChLP винт Ø2,4

L

Ø2,4


1,8

Ø wiertła do gwintudrill bit for thread holeсверло для резьбы

40.2063.220 1,8


40.5673.018 5,0/1,8


40.5676.000 S2,5


40.5677.000 T15

Ø4,5

2,5 T15






IMPLANTS

25

Nr katalogowy, Catalogue no., № по кат.

TYTAN, Titanium, Титан

3.1221.050

Wkrętak trójramiennyScrewdriverОтвертка

40.4746

5,0 ChLP wkręt do cerklarzu5.0ChLP cerclage screws5,0 ChLP серкляжный винт

5,0ChLP wkręt oporowy5.0ChLP distance screw5,0ChLP дистанционный винт

5,0ChLP wkręt zaślepiający5.0ChLP screw hole insert 5,0ChLP заглушка

L2,5 T15


L[mm] Tytan, Titanium, Титан

6 3.1289.006 3.5207.006

2,5 T15



3.1381.000 3.5208.000

Ø5,0

Ø5,0

Ø3,5

Wkręt korowy Ø3,5Cortical screw Ø3.5Винт кортикальный Ø3,5

L

Ø3,5

3,1

Ø6,0



2,4

Ø wiertło drill сверло

40.2049.220 2,5

prowadnica kompresyjnacompression guideнаправитель компрессионный

40.4804.000 2,5


40.5676.000 S2,5


40.5677.000 T15


40.2548.000 HA3,5

2,5 T15


L[mm] Tytan, Titanium, Титан10 3.1283.010 3.1306.01012 3.1283.012 3.1306.01214 3.1283.014 3.1306.01416 3.1283.016 3.1306.01618 3.1283.018 3.1306.01820 3.1283.020 3.1306.02022 3.1283.022 3.1306.02224 3.1283.024 3.1306.02426 3.1283.026 3.1306.02628 3.1283.028 3.1306.02830 3.1283.030 3.1306.03032 3.1283.032 3.1306.03234 3.1283.034 3.1306.03436 3.1283.036 3.1306.03638 3.1283.038 3.1306.03840 3.1283.040 3.1306.04045 3.1283.045 3.1306.04550 3.1283.050 3.1306.05055 3.1283.055 3.1306.05560 3.1283.060 3.1306.06065 3.1283.065 3.1306.06570 3.1283.070 3.1306.07075 3.1283.075 3.1306.07580 3.1283.080 3.1306.08085 3.1283.085 3.1306.08590 3.1283.090 3.1306.09095 3.1283.095 3.1306.095100 3.1283.100 3.1306.100105 3.1283.105 3.1306.105110 3.1283.110 3.1306.110


IMPLANTS

26

Statyw na wkrety 5,0ChLP; Stand for screws 5.0ChLP; Подставка для винтов 5,0ChLP



Szt.,Pcs,Шт.

1 40.5748.400 Statyw na wkrety 5,0ChLP Stand for screws 5.0ChLP Подставка для винтов 5,0ChLP 1

40.5

748.

500


306x272x135мм 1





40.5748.500

40.5748.400


IMPLANTS

27

Narzędzia do płytki 5,0ChLP; Instruments for 5.0ChLP plate; Инструменты для пластины 5,0ChLP



Szt.,Pcs,Шт.

1 40.5673.010 Tuleja prowadząca 5,0/1,0 Guide sleeve 5.0/1.0 Втулка направляющая 5,0/1,0 2

40.5

667.

600

2 40.5673.018 Tuleja prowadząca 5,0/1,8 Guide sleeve 5.0/1.8 Втулка направляющая 5,0/1,8 23 40.5673.025 Tuleja prowadząca 5,0/2,5 Guide sleeve 5,0/2,5 Втулка направляющая 5,0/2,5 24 40.5673.028 Tuleja prowadząca 5,0/2,8 Guide sleeve 5.0/2.8 Втулка направляющая 5,0/2,8 45 40.4804.000 Prowadnica kompresyjna 2,5/2,8 Compression guide 2.5/2.8 Направитель компрессионный 2,5/2,8 16 40.2063.220 Wiertło 1,8/220 Drill 1.8/220 Сверло 1,8/220 27 40.5912.220 Wiertło ze skalą 2,5/220 Drill with scale 2.5/220 Сверло c измерительной шкалой 2,5/220 28 40.5653.220 Wiertło ze skalą 2,8/220 Drill with scale 2.8/220 Сверло c измерительной шкалой 2,8/220 19 40.4814.220 Drut Kirschnera 1,0/220 Kirschner wire 1.0/220 Cпица Киршнера 1,0/220 410 40.4815.220 Drut Kirschnera 2,0/220 Kirschner wire 2.0/220 Cпица Киршнера 2,0/220 411 40.5674.028 Wkręt ustalająco-dociskowy 2,8/180 Setting-compressing screw 2.8/180 Bинт установочно- нажимной 2,8/180 212 40.5675.100 Wzorzec długości wkrętów Screw length measure Измеритель длины винтов 113 40.4639.000 Wzorzec głębokości Depth measure Измеритель глубины 114 40.5676.000 Grot S2,5 Screwdriver tip S2.5 Наконечник под S2,5 115 40.5677.000 Grot T15 Screwdriver tip T15 Наконечник под T15 116 40.5635.100 Rękojeść dynamometryczna 2,0Nm Handle 2.0Nm Рукоятка 2,0Nm 117 40.4250.000 Zaginak do płytek 4/6 Bender for plates 4/6 Изгибатель пластин 4/6 218 40.0321.000 Wkrętak sześciokątny S 2,5 Hexagonal screwdriver S2.5 Отвертка под шестигранник S2,5 119 40.0670.000 Wkrętak sześciokarbowy T15 Screwdriver T15 Отвертка T15 120 40.2548.000 Gwintownik HA 3,5 z rączką Cortical tap HA 3.5 with handle Метчик HA 3,5 (ручной) 121 40.5661.000 Gwintownik 5,0ChLP-3,5 Tap 5.0ChLP-3.5 Метчик 5,0ChLP-3,5 122 40.4746.000 Wkrętak trójramienny Screwdriver Отвертка 1

23 40.5668.600 Statyw na narzędzia do płytki 5,0ChLP Stand for instrument set of 5.0ChLP plate Подставка для инструментов 5,0ChLP пластин 1

1. Tuleja prowadząca 5,0/1,0; Guide sleeve 5.0/1.0; Втулка направляющая 5,0/1,0 [40.5673.010]2. Tuleja prowadząca 5,0/1,8; Guide sleeve 5.0/1.8; Втулка направляющая 5,0/1,8 [40.5673.018]3. Tuleja prowadząca 5,0/2,5: Guide sleeve 5,0/2,5; Втулка направляющая 5,0/2,5 [40.5673.025]4. Tuleja prowadząca 5,0/2,8; Guide sleeve 5.0/2.8; Втулка направляющая 5,0/2,8 [40.5673.028]

5. Prowadnica kompresyjna 2,5/2,8; Compression guide 2.5/2.8; Направитель компрессионный 2,5/2,8 [40.4804.000]

9. Drut Kirschnera 1,0/220; Kirschner wire 1.0/220; Cпица Киршнера 1,0/220 [40.4814.220]10. Drut Kirschnera 2,0/220; Kirschner wire 2.0/220; Cпица Киршнера 2,0/220 [40.4815.220]

11. Wkręt ustalająco-dociskowy 2,8/180; Setting-compressing screw 2.8/180; Bинт установочно-нажимной 2,8/180 [40.5674.028]

12. Wzorzec długości wkrętów; Screw length measure; Измеритель длины винтов [40.5675.100]

6. Wiertło 1,8/220; Drill 1.8/220; Сверло 1,8/220 [40.2063.220]7. Wiertło ze skalą 2,5/220; Drill with scale 2.5/220; Сверло c измерительной шкалой 2,5/220 [40.5912.220]8. Wiertło ze skalą 2,8/220; Drill with scale 2.8/220; Сверло c измерительной шкалой 2,8/220 [40.5653.220]


INSTRUMENTS

III.2. Instruments

28

13. Wzorzec głębokości; Depth measure; Измеритель глубины [40.4639.000]

14. Grot S2,5; Screwdriver tip S2.5; Наконечник под S2,5 [40.5676]15. Grot T15; Screwdriver tip T15; Наконечник под T15 [40.5677] 16. Rękojeść dynamometryczna 2,0Nm; Handle 2.0Nm;

Рукоятка 2,0Nm [40.5635.100]

17. Zaginak do płytek 4/6; Bender for plates 4/6; Изгибатель пластин 4/6 [40.4250.000]

18. Wkrętak sześciokątny S2,5; Hexagonal screwdriver S2.5; Отвертка под шестигранник S2,5 [40.0321.000]19. Wkrętak sześciokarbowy T15; Screwdriver T15; Отвертка T15 [40.0670.000]

20. Gwintownik HA 3,5 z rączką; Cortical tap HA 3.5 with handle;Метчик HA 3,5 (ручной) [40.2548.000]

21. Gwintownik 5,0ChLP-3,5; Tap 5.0ChLP-3.5;Метчик 5,0ChLP-3,5 [40.5661.000]

22. Wkrętak trójramienny; Screwdriver; Отвертка [40.4746.000]

23. Statyw na narzędzia do płytki 5,0ChLP; Stand for instrument set of 5.0ChLP plate;Подставка для инструментов 5,0ChLP пластин[40.5668.600]

21. Gwintownik 5,0ChLP-3,5; Tap 5.0ChLP-3.5;Метчик 5,0ChLP-3,5 [40.5661.000]

20. Gwintownik HA 3,5 z rączką; Cortical tap HA 3.5 with handle;Метчик HA 3,5 (ручной) [40.2548.000]


INSTRUMENTS

29

16. Rękojeść dynamometryczna 2,0Nm; Handle 2.0Nm; Рукоятка 2,0Nm [40.5635.100]


SURGICAL TECHNIQUE

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

III.3. Indications

5.0 ChLP System is designed for fractures fixation, osteotomy and in case of nonunions for:• clavicula;• scapula;• humerus;• radius;• ulna;• pelvis;• tibia;• fibula.


30

40.4815.22040.4815.220

40.5674.028

40.5673.028


SURGICAL TECHNIQUE


III.4. Surgical technique

III.4.1. Temporary attachment of the plate

After fracture is reduced and plate position is confi rmed, Kirschner Wires 2.0 [40.4815.220] shall be temporary attached. Wires can be inserted into the proximal hole of the plate as well as into the most distal hole.

Confi rm the correct plate position with X-Ray image.

Note:The Setting-Compressing Screw 2.8/180 [40.5674.028] can be used for temporary stabilization of the plate and for tightening to the bone. The screw is to be inserted via the Guide Sleeve 5.0/2.8 [40.5673.028].After the Setting-Compressing Screw 2.8/180 is removed, locking screw 3.5 can be inserted into the hole.

Insert Self Drilling Pin of Setting-Compressing Screw.

Tightening the sleeve pulls the plate to the bone.



SURGICAL TECHNIQUE


III.4.2. Locking screw 3.5 insertion

Guide sleeve insertingInsert the Guide Sleeve 5.0/2.8 [40.5673.028] into the plate.

Hole drillingReam using the Drill With Scale 2.8/220 [40.5653.220] until the desire depth is reached.



SURGICAL TECHNIQUE


Hole depth measurementOPTION I Read the value on the Drill With Scale [40.5653.220]or

OPTION II: use the Screw Length Measure [40.5675.100].

OPTION III: Unscrew the Guide Sleeve 5.0/2.8 [40.5673.028] and defi ne the screw length using the Depth Measure [40.4639.000]



SURGICAL TECHNIQUE


Screw insertionRemove the Guide Sleeve 5.0/2.8 [40.5673.028].

Insert the locking screw 3.5 using the Handle 2.0 Nm [40.5635] and proper screwdriver tip .



SURGICAL TECHNIQUE


III.4.3. Cortical screw 3.5 insertion

Compression guide settingSet the compression guide 2.5/2.8 [40.4804.0000] in the desire position:

a) Neutral position

Press the guide sleeve to the plate to achie-ve the neutral position for screw insertion

b) Compressive position.

Move the guide sleeve without pressure to the edge of compression hole to achieve the compression position for screw inser-tion.

c) Angular position

Angular positioning of the guide sleeve is available as well.



SURGICAL TECHNIQUE


Hole depth measurement Insert the Depth Measure [40.4639.000] into drilled hole until its hook anchors the outer surface of opposite cortex

Screw insertionInsert cortical screw 3.5

DrillingDrill the hole through both cortices in the desire position for cortical screw 3.5 using the Drill 2.5/220 [40.5912.220]

36

7,0ChLP Płytka szeroka, kompresyjna z ograniczonym kontaktem7.0ChLP Wide compression plate with limited contact7,0ChLP Пластина широкая компрессирующая с ограниченным контактом

L



6 142 3.3155.5068 184 3.3155.50810 226 3.3155.51012 268 3.3155.51214 310 3.3155.514




17,5

5,0

Paleta na płytki 7,0ChLP - proste; Palette for 7.0ChLP plates - straight; Поддон для пластин 7,0ChLP - прямые



Szt.,Pcs,Шт.


40.5

704.

550


595x275x86мм 1






Ø5,0


Ø4,5


IMPLANTS

IV. SYSTEM 7.0

IV.1. Implants

37

7,0ChLP Płytka kłykciowa udowa7.0ChLP Condylar femur plate7,0ChLP Пластина для мыщелков бедренной кости

L R

L



O L[mm]



4 153 3.4023.504 3.4024.5046 195 3.4023.506 3.4024.5068 237 3.4023.508 3.4024.50810 279 3.4023.510 3.4024.510







Szt.,Pcs,Шт.


40.5

704.

310

40.5

704.





595x275x86мм 1






Ø5,0


Ø5,0


Ø4,5


Ø7,3


IMPLANTS

38

7,0ChLP Płytka kłykciowa piszczelowa7.0ChLP Tibial condylar plate 7,0ChLP Пластина для мыщелков большеберцовой кости



O L[mm]



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




L

LR




Szt.,Pcs,Шт.


40.5

704.

320

40.5

704.





595x275x86мм 1






Ø5,0


Ø5,0


Ø4,5


IMPLANTS

39

7,0ChLP Płytka piszczelowa szeroka7.0ChLP Wide tibia plate7,0ChLP Широкая пластина для большеберцовой кости

LR

L



O L[mm]



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







Szt.,Pcs,Шт.


40.5

704.

540


595x275x86мм 1






Ø5,0


Ø5,0


Ø4,5


IMPLANTS

40

7,0CHLP Płytka piszczelowa bliższa boczna7,0CHLP Proximal lateral tibia plate7,0CHLP Пластина большеберцовая проксимальная латеральная

L

R L



O L[mm]



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







Szt.,Pcs,Шт.


40.5

704.

360

40.5

704.





595x275x86мм 1






Ø5,0


Ø5,0


Ø4,5


IMPLANTS

41

7,0ChLP płytka udowa bliższa7.0ChLP femoral proximal plate7.0ChLP пластина для бедренной кости проксимальная

Lewa, Left, ЛеваяNr katalogowy,

Catalogue no., № по кат.O L [mm] TYTAN, Titanium, Титан2 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

Prawa, Right, ПраваяNr katalogowy,

Catalogue no., № по кат.O L [mm] TYTAN, Titanium, Титан2 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

O - liczba otworów gwintowanych w części trzonowej płytkiколичество резьбовых отверстий в диафизной части пластиныthreaded holes number in shaft part of the plate

L

LR

Tytan, Titanium, Титан3.1448.016-110

Ø5,0


Ø4,5


Ø5,0


Ø7,3




Szt.,Pcs,Шт.

1 40.5732.100 Nakładka celująca [3.7023] Targeting block [3.7023] Целенаправительная накладка [3.7023] 1

40.5

704.

390

40.5

704.

5902 40.5732.200 Nakładka celująca [3.7022] Targeting block [3.7022] Целенаправительная накладка [3.7022] 1

3 40.5708.000 Tuleja ochronna 9,0/7,0 Protective guide 9.0/7.0 Втулка зажимная 9,0/7,0 2



595x275x86мм 1


Lid perforated alu. 1/1 595x275x15mm Grey




IMPLANTS

42

7,0ChLP Wkręt Ø5,07.0ChLP Screw Ø5.07,0ChLP Винт Ø5,0

L

Ø5,0

Ø7,0



3,5 T25


L[mm] Tytan, Titanium, Титан16 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


4,0


40.5651.220 4,0


40.5705.040 7,0/4,0


40.5686.000 S3,5


40.5684.000 T25


40.5646.000 5,0

Ø7,0

Ø5,0

L

3,5 T25





7,0 ChLP Wkręt stożkowy samogwintujący Ø5,07,0 ChLP Conical self - tapping screw Ø5.07,0 ChLP Винт конический самонарезающий Ø5,0


IMPLANTS

43

Nr katalogowy, Catalogue no., № по кат.

TYTAN, Titanium, Титан

3.1221.070

Wkrętak trójramiennyScrewdriverОтвертка

40.4746.000

7,0 ChLP wkręt do cerklarzu7.0ChLP cerclage screws7,0 ChLP серкляжный винт

7,0ChLP wkręt oporowy7.0ChLP distance screw7,0ChLP дистанционный винт

7,0ChLP wkręt zaślepiający7.0ChLP screw hole insert 7,0ChLP заглушка

L

Ø5,0

Ø7,0

Ø7,0

3,5 T25



8 3.1448.008 3.5219.008

3,5 T25



8 3.1382.000 3.5220.000

Wkręt korowy Ø4,5Cortical screw Ø4.5Винт кортикальный Ø4,5

L

Ø4,5

4,6

Ø8,0


3,5 T25


L[mm] Tytan, Titanium, Титан16 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


3,0

Øwiertła do gwintudrill bit for thread holeсверло для резьбы

40.5650.220 3,2

prowadnica kompresyjnacompression guideнаправитель компрессионный

40.4802.032 3,2


40.5686.000 S3,5


40.5684.000 T25


40.5647.000 HA4,5


IMPLANTS

44

7,0ChLP Wkręt kaniulowany Ø7,3x16 7.0ChLP Cannulated screw Ø7.3x167,0ChLP Винт канюлированный Ø7,3x16

16

samowiercącyself-drillingсамосверлящий

7,0ChLP Wkręt kaniulowany Ø7,37.0ChLP Cannulated screw Ø7.37,0ChLP Винт канюлированный Ø7,3

L

Ø7,3

Ø9,0


5,0

Ø2,2

T30

Ø2,2


L[mm] Tytan, Titanium, Титан30 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


L[mm] Tytan, Titanium, Титан30 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


5,2

Ø drut KirschneraKirschner wireСпица Киршнера

40.4815.220 2,0


40.5654.120/150 5,0/2,0


40.5652.220 5,0/2,0


40.5654.150 5,0


40.5687.000 S5


40.5685.000 T30

L

Ø7,3

Ø9,0 Ø9,0

Ø9,0

16L

L

Ø7,3

Ø7,3

7,0 ChLP Wkręt stożkowy kaniulowany Ø7,3x167.0 ChLP Conical cannulated screw Ø7.3x167,0 ChLP Винт канюлированный конический Ø7,3x16

7,0 ChLP Wkręt stożkowy kaniulowany Ø7,37.0 ChLP Conical cannulated screw Ø7.37,0 ChLP Винт канюлированный конический Ø7,3


16

5,0

Ø2,2

T30

Ø2,2


L[mm] Tytan, Titanium, Титан30 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




IMPLANTS

45

7,0ChLP wkręt gąbczasty Ø6,57.0ChLP cancellous screw Ø6.57,0ChLP винт спонгиозный Ø6,5

L


3,0


40.5650.220 3,2


40.5707.032 3,2


40.5687.000 S5


40.5685.000 T30

5,0 T30



Ø9,0

Ø6,5


3,5 T25



7,0ChLP wkręt gąbczasty Ø5,47.0ChLP Cancellous screw Ø5,47,0ChLP Винт спонгиозный Ø5,4

LØ

rdzeniacoreстержень

3,2


40.5650.220 3,2


40.5705.032 3,2


40.5686.000 S3,5


40.5684.000 T25

Ø5,4

Ø7,0



IMPLANTS

46

Statyw na wkrety 7,0ChLP; Stand for screws 7.0ChLP; Подставка для винтов 7,0ChLP



Szt.,Pcs,Шт.

1 40.5749.400 Statyw na wkrety 7,0ChLP Stand for screws 7.0ChLP Подставка для винтов 7,0ChLP 1

40.5

749.

500


306x272x135мм 1





40.5749.400

40.5749.500


IMPLANTS

47

1. Tulejka prowadząca 7,0/2,0; Guide sleeve 7.0/2.0; Втулка направляющая 7,0/2,0 [40.5705.020]2. Tulejka prowadząca 7,0/3,2; Guide sleeve 7.0/3.2; Втулка направляющая 7,0/3,2 [40.5705.032]3. Tulejka prowadząca 7,0/4,0; Guide sleeve 7.0/4.0; Втулка направляющая 7,0/4,0 [40.5705.040]

1. Tulejka prowadząca 7,0/2,0; Guide sleeve 7.0/2.0; Втулка направляющая 7,0/2,0 [40.5705.020]2. Tulejka prowadząca 7,0/3,2; Guide sleeve 7.0/3.2; Втулка направляющая 7,0/3,2 [40.5705.032]3. Tulejka prowadząca 7,0/4,0; Guide sleeve 7.0/4.0; Втулка направляющая 7,0/4,0 [40.5705.040]

4. Prowadnica kompresyjna 3,2; Compression guide 3.2; Направитель компрессионный 3,2 [40.4802.032]

8. Drut Kirschnera 2,0/220; Kirschner wire 2.0/220; Спица Киршнера 2,0/220 [40.4815.220]

9. Wkręt ustalająco-dociskowy 4,0/180; Setting-compressing screw 4.0/180; Bинт установочно-нажимной 4,0/180 [40.5706.040]

10. Wzorzec długości wkrętów; Screw length measure; Измеритель длины винтов [40.5675.100]

5. Wiertło ze skalą 3,2/220; Drill with scale 3.2/220; Сверло c измерительной шкалой 3,2/220 [40.5650.220]6. Wiertło ze skalą 4,0/220; Drill with scale 4.0/220; Сверло c измерительной шкалой 4,0/220 [40.5651.220]7. Wiertło kaniulowane ze skalą 5,0/2,2/220; Cannulated drill with scale 5,0/2,2/220; Сверло канюлированное с

измерительной шкалой 5,0/2,2/220 [40.5652.220]

Narzędzia do płytki 7,0ChLP; Instruments for 7.0ChLP plate; Инструменты для пластины 7,0ChLP



Szt.,Pcs,Шт.

1 40.5705.020 Tulejka prowadząca 7,0/2,0 Guide sleeve 7.0/2.0 Втулка направляющая 7,0/2,0 2

40.5

702.

600

2 40.5705.032 Tulejka prowadząca 7,0/3,2 Guide sleeve 7.0/3.2 Втулка направляющая 7,0/3,2 23 40.5705.040 Tulejka prowadząca 7,0/4,0 Guide sleeve 7.0/4.0 Втулка направляющая 7,0/4,0 44 40.4802.032 Prowadnica kompresyjna 3,2 Направитель компрессионный 3,2 1

5 40.5650.220 Wiertło ze skalą 3,2/220 Drill with scale 3.2/220 Сверло c измерительной шкалой 3,2/220 2

6 40.5651.220 Wiertło ze skalą 4,0/220 Drill with scale 4.0/220 Сверло c измерительной шкалой 4,0/220 2

7 40.5652.220 Wiertło kaniulowane ze skalą 5,0/2,2/220 Cannulated drill with scale 5,0/2,2/220

Сверло канюлированное с измерительной шкалой 5,0/2,2/220

2

8 40.4815.220 Drut Kirschnera 2,0/220 Kirschner wire 2.0/220 Спица Киршнера 2,0/220 49 40.5706.040 Wkręt ustalająco - dociskowy 4,0/180 Setting-compressing screw 4.0/180 Bинт установочно- нажимной 4,0/180 210 40.5675.100 Wzorzec długości wkrętów Screw length measure Измеритель длины винтов 111 40.4639.000 Wzorzec głębokości Depth measure Измеритель глубины 112 40.5686.000 Grot S3,5-1/4 Screwdriver tip S 3.5-1/4 Наконечник S3.5-1/4 113 40.5684.000 Grot T25-1/4 Screwdriver tip T 25-1/4 Наконечник T25-1/4 114 40.5270.400 Klucz dynamometryczny Torque wrench Ключ динамометрический 115 40.4250.000 Zaginak do płytek 4/6 Bender for plates 4/6 Изгибатель пластин 4/6 216 40.5707.032 Tulejka prowadząca 3,2 Guide sleeve 3.2 Втулка направляющая 3,2 117 40.5654.150 Tulejka prowadząca 5,0 Guide sleeve 5.0 Втулка направляющая 5,0 118 40.5654.120 Tulejka prowadząca 5,0/2,0 Guide sleeve 5.0/2.0 Втулка направляющая 5,0/2,0 1

19 40.5687.000 Grot kaniulowany S5-1/4 Cannulated screwdriver tip S5-1/4 Наконечник под шестигранник канюлированный S5-1/4 1

20 40.5685.000 Grot kaniulowany T30-1/4 Cannulated screwdriver tip T30-1/4 Наконечник под шестигранник канюлированный T30-1/4 1

21 40.0672.000 Wkrętak sześciokarbowy kaniulowany T30 Cannulated screwdriver T30 Hexagonal screwdriver S2.5 1

22 40.0671.000 Wkrętak sześciokarbowy T25 Screwdriver T25 Отвертка T25 123 40.0320.000 Wkrętak sześciokątny S3,5 Hexagonal screwdriver S3.5 Отвертка под шестигранник S3,5 124 40.4817.000 Wkrętak kaniulowany S5 Cannulated screwdriver S5 Отвертка канюлированная S5 125 40.5646.000 Gwintownik 7,0ChLP -5,0 Tap 7.0ChLP -5.0 Метчик 7,0ChLP -5,0 126 40.5647.000 Gwintownik HA 4,5 Cortical tap HA 4.5 Метчик HA 4,5 127 40.4746.000 Wkrętak trójramienny Screwdriver Отвертка 1

28 40.5703.600 Statyw na narzędzia do płytki 7,0ChLP Stand for instrument set of 7.0ChLP plate Подставка для инструментов 7,0ChLP пластин 1


INSTRUMENTS

IV.2. Instruments

48

14. Klucz dynamometryczny; Torque wrench;Ключ динамометрический [40.5270.400]

15. Zaginak do płytek 4/6; Bender for plates 4/6; Изгибатель пластин 4/6 [40.4250.000]

28. Statyw na narzędzia do płytki 7,0ChLP; Stand for instrument set of 7.0ChLP plate;Подставка для инструментов 7,0ChLP пластин [40.5703.600]

14. Klucz dynamometryczny; Torque wrench;Ключ динамометрический[40.5270.400]

17. Tulejka prowadząca 5,0; Guide sleeve 5.0; Втулка направляющая 5,0 [40.5654.150]

18. Tulejka prowadząca 5,0/2,0; Guide sleeve 5.0/2.0; Втулка направляющая 5,0/2,0 [40.5654.120]

19. Grot kaniulowany S5-1/4; Cannulated screwdriver tip S5-1/4; Наконечник под шестигранник канюлированный S5-1/4 [40.5687]20. Grot kaniulowany T30-1/4; Cannulated screwdriver tip T30-1/4; Наконечник под шестигранник канюлированный S5-1/4 [40.5685]

16. Tulejka prowadząca 3,2; Guide sleeve 3.2; Втулка направляющая 3,2 [40.5707.032]

11. Wzorzec głębokości ; Depth measure; Измеритель глубины [40.4639.000]

12. Grot S3,5-1/4; Screwdriver tip S3.5-1/4; Наконечник S3.5-1/4 [40.5686]13. Grot T25-1/4; Screwdriver tip T25-1/4; Наконечник T25-1/4 [40.5684]

27. Wkrętak trójramienny; Screwdriver; Отвертка [40.4746.000]

26. Gwintownik HA 4,5; Cortical tap HA 4.5; Метчик HA 4,5 [40.5647.000]

25. Gwintownik 7,0ChLP-5,0; Tap 7.0ChLP-5.0; Метчик 7,0ChLP -5,0 [40.5646.000]

21. Wkrętak sześciokarbowy kaniukowany T30; Cannulated screwdriver T30; Hexagonal screwdriver S2.5 [40.0672.000]22. Wkrętak sześciokarbowy T25; Screwdriver T25; Отвертка T25 [40.0671.000]23. Wkrętak sześciokątny S3,5; Hexagonal screwdriver S3.5 Отвертка под шестигранник S3,5 [40.0320.000]24. Wkrętak kaniulowany S5; Cannulated screwdriver S5; Отвертка канюлированная S5 [40.4817.000]


INSTRUMENTS



SURGICAL TECHNIQUE


IV.3. Indications

7.0 ChLP System is designed for long bones fractures stabilization:• femur;• tibia;• humerus.

Wide plates are mainly used for diaphysis fractures stabilization.Contoured plates are used for metaphysic fractures, including simple and multifragmental fractures, lateral and medial wedge fractu-res, condylar fractures and combined with diaphysis fractures.


50

40.4815.220 40.4815.220

40.5706.040

40.5705.040


SURGICAL TECHNIQUE


IV.4. Surgical technique

IV.4.1. Temporary plate attachment

After fracture is reduced and plate position is confi rmed, determi-ne its temporary location using Kirschner Wires 2.0 [40.4815.220]. Wires can be inserted in proximal holes of the plate and the most distal holes.

Confi rm the correct plate position with X-Ray image.

NOTE:The Setting-Compressing Screw 4.0/180 [40.5706.040] can be used for temporary stabilization of the plate and to tighten it up to the bone. The screw is to be inserted via the Guide Sleeve 7.0/4.0 [40.5705.040].Locking screw 5.0 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 of the sleeve pulls the plate to the bone.



SURGICAL TECHNIQUE


IV.4.2. Locking screw 5.0 insertion

Guide sleeve screwingInsert the Guide Sleeve 7.0/4.0 [40.5705.040] into the plate

Drilling the holeReam the hole using the Drill With Scale 4.0/220 [40.5651.220] until the desire depth is reached.



SURGICAL TECHNIQUE


Hole depth measurementOPTION I: Read the value on the Drill With Scale [40.5651.220] or.

OPTION II: Use the Screw Length Measure [40.5675.100]. .

OPTION III: Unscrew the Guide Sleeve 7.0/4.0 [40.5705.040] and defi ne the screw length using the Depth Measure [40.4639.000].



SURGICAL TECHNIQUE


Screw insertionRemove the Guide Sleeve 7.0/4.0 [40.5705.040]

Insert the locking screw 5.0 using the Handle [40.5270.400] and proper screwdriver tip



SURGICAL TECHNIQUE


b) Compressive position.

Move the Guide Sleeve without pressure to the edge of compression hole to achieve the com-pression position for screw insertion.

c) Angular position

Angular positioning of the guide sleeve is ava-ilable

IV.4.3. Cortical screw 5.0 insertion

Compression guide settingSet the Compression Guide 3.2 [40.4804.032] in desire position:

a) Neutral position

Press the guide sleeve to the plate to achieve the neutral position for screw insertion



SURGICAL TECHNIQUE


Screw insertionInsert cortical screw 4.5

Hole depth measurementInsert the Depth Measure [40.4639.000] into drilled hole until its hook anchors the outer surface of opposite cortex

DrillingDrill the hole through both cortices in desire position for the corti-cal screw 4.5 using the Drill 3.2/220 [40.5650.220]

56

* **


SURGICAL TECHNIQUE


IV.4.4. Introduction of 7.3 Locked Screw

There is a larger hole at the center of the femoral plate [L-3.4023, P-3.4024] for self-drilling cannulated screw 7.3mm [3.1664.xxx].

Measuring the hole depth Insert Kirschner wire 2.0 [40.4815.220] to specify the length of screw by using the Screw Length Measure [40.5675.100].

Introduction of the screw 7.3Remove the Guide Sleeve. Insert the locking screw 7.3 using the Torque Wrench [40.5270.400] and propper canulated tip.

Note:

* Remove the Guide Sleeve 5.0/2.0 [40.5654.120] and read the value using the Screw Length Measure [40.5675.100].

** In case of measuring without removing the Guide Sleeve 5.0/2.0 [40.5654.120] subtract 5mm from the measured value.

Insertion of Guide Sleeve Insert the Guide Sleeve 9.0/5.0 [40.5654.150] into the Guide Sleeve 5.0 / 2.0 [40.5654.120] for Kirchner wire 2.0 [40.4815.220].



SURGICAL TECHNIQUE


V. POSTOPERATIVE TREATMENT

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

VI. IMPLANT REMOVAL

In order to remove the screws, fi rst unlock all screws from the plate. Then remove bone screws. This prevents the rotation of the plate while removing the last screw.

Note: Usage of the Cannulated Drill With Scale 5.0/2.2/220 [40.5652.220]

In the case of hard bone use he Cannulated Drill With Scale 5.0/2.2/220 [40.5652.220]. Drilled shall be carried through the Gide Sleeve 9.0 / 5.0 [40.5654.150] via Kirchner Wire 2.0 [40.4815.220].



INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USEImportant product information for

LOCKING PLATES AND SCREWS

STERILE R

NON

STERILE

PURPOSE AND INDICATIONSLocking 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 specified screws which are listed in ChM Ltd Product Catalogue. ChM Ltd does not recommend any specific surgical approach for particular patient. CONTRAINDICATIONS• Infection or inflammation 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.• Insufficient 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 fixation failure.

• Neuromuscular disorder which would create unacceptable risk of fixation failure or complications in postoperative care.

• Any other condition which would preclude the potential benefit of implant usage and disturb the normal process of bone remodeling, 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 differential 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 calcification problem should not be considered for this type of surgery.

• 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 benefits of surgery.• Situation which acc. to the physician assessment there is any contraindication for metal implant fixation.

The above list is not exhaustive.ADVERSE EFFECTSThe adverse effects may necessitate reoperation or revision. The surgeon should warn the patient about possibility of adverse effects occurrence.Potential adverse events include but are not limited to:• Infection and other adverse inflammatory 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, proper 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 flexibility, strength, reliability and durability of normal, healthy bones.Overweight may cause in implant additional stresses and strains which can lead to fatigue and deformation or in consequence 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 walking, 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 hardness increases and ductility (bendability) decreases. Excessive bending can lead to postoperative fracture of the plate. Due to potential 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 fit 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 proper axial pressure shall be applied to ensure the screwdriver recessing in the head of the bone screw as possible. Sensitive tightening 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 identification 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 Ø4.0, 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. Not labeled implants are non-sterile.

3. Package of each components should be intact at the time of receipt.4. 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. 5. A sterile indicator is put on the sterile package.6. 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”” (first 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, -batch code (LOT), for example, „0900000”, -NON-STERILE sign: indicates non-sterilized product, -catalogue number (REF), e.g.: „3.4034.503”” (first digit indicates the material type e.g.: 1.4034.503/1- implantable steel, 3.4034.503/3-titanium).

7. Additionally the package contains: instruction for use and labels placed in a patient’s medical record.

8. 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” (first 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”.

9. 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” (first digit indicates the material type e.g.: 1.4034.503/1-steel, 3.4034.503/3-titanium), -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 breaking of instruments has been occasionally reported. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. ChM Ltd. recommends that all instruments be regularly inspected for wear and disfigurement.

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 compatible:• 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 conductivity, there is no contraindications for carrying out magnetic resonance imaging (MRI), using magnetic field strength of maximum 3 Tesla.

However, the user should be absolutely familiar with the contraindications and warnings established by manufacturer 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 avoided.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 effects of such treatment. Proper clinical diagnosis and accurate operation planning and performance, are needed to achieve a good final 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 having undergone the necessary specific training in use of instruments produced by ChM Ltd. Surgical technique adequate for specific 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 surgery. 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.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 procedure (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 implantation shall undergone cleaning and sterilization procedure. Preparation for cleaning

Remove possible surface contamination using a disposable cloth, paper towel or plastic brushes (nylon brushes are recommended). 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 specified by the producer of those detergent. It is recommended to use water solutions 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 cleaning holes.

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

• Next rinse thoroughly under flowing 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 recommended 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 procedures. 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.

CAUTION: -Sterilization must be effective and in accordance with requirements of the EN 556 standard, which states, that theoretical probability 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. Based on observation and postoperative period the surgeon determines how long

implant shall be implanted in the patient’s body. Implant shall be remove after treatment. Steel implant shall be removed after period of not more than two years after its implantation.

2. Implant is intended for single use only. After removing the implant from the patient’s body it must not be re-used. Final disposal of implant shall be carried in accordance with current hospital procedures.

3. 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.

4. Implant, which had contact with tissues and body fluids of the other patient cannot be re-implanted.

5. Avoid damaging implant surface and the deformation of implant shape during the implantation, the damaged implant cannot be left or implanted in the patient’s body.

6. Slippage or misuse of instruments or implants may cause injury to the patient or operative personnel.

7. 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 manufacturers may cause damage or failure of those implants or instruments and may lead to improper course of surgery and healing process.

8. Intraoperative fracture or breaking of instruments has been occasionally reported. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. It is recommends to inspect all instruments for wear and disfigurement. 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 confirm proper position of the implant by roentgenographic examination.2. In postoperative period, an immobilization of union should be confirmed 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 fixation or implant failure 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 walking, 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 examination.

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.

If this instruction appears unclear, please contact the manufacturer / distributor, who shall provide all required explanation.

U/NS/R-010/12; Date of verification: January 2012


Manufacturer: ChM sp. z o.o.Lewickie 3b, 16-061 Juchnowiec K., Polandtel.: +48 85 713-13-20 fax: +48 85 713-13-19e-mail: [email protected] www.chm.eu

IFU-I-001/14

Manufacturer: ChM sp. z o.o.Lewickie 3b, 16-061 Juchnowiec K., Polandtel.: +48 85 713-13-20 fax: +48 85 713-13-19e-mail: [email protected] www.chm.eu

SYMBOL TRANSLATION • OBJAŚNIENIA SYMBOLI • ПОЯСНЕНИЕ ОБОЗНАЧЕНИЙ EXPLICACIÓN DE LOS SÍMBOLOS • SYMBOLERKLÄRUNG • SYMBOLY PŘEKLADY

Do not reuseNie używać powtórnie

Не использовать повторноNo reutilizar

Nicht wiederverwendenNepoužívejte opakovaně

Do not resterilizeNie sterylizować ponownie

Не стерилизовать повторноNo reesterilizar

Nicht resterilisierenNepoužívejte resterilizaci

Do not use if package is damagedNie używać jeśli opakowanie jest uszkodzone

Не используйте при поврежденной упаковкеNo utilizar si el envase está dañado

Nicht verwenden falls Verpackung beschädigt istNepoužívejte, pokud je obal poškozen

Sterilized using irradiationSterylizowany przez napromieniowanie

Стерилизация облучениемEsterilizado mediante radiación

Sterilisiert durch BestrahlungSterilizovat zářením

Sterilized using ethylene oxideSterylizowany tlenkiem etylenuСтерилизация окисью этилена

Esterilizado mediante óxido de etilenoSterilisiert mit EthylenoxidSterilizovat ethylenoxidem

Non-sterileNiesterylny

НестерильноNo estérilUnsteril

Nesterilní

STERILE R STERILE EO NONSTERILE

Catalogue numberNumer katalogowyНомер по каталогуNúmero de catálogo

KatalognummerKatalogové číslo

Batch codeKod partii

Код партииCódigo de lote

ChargennummerČíslo šarže

Consult instructions for useZajrzyj do instrukcji używania

Смотри инструкцию по применениюConsultar instrucciones de uso

Siehe die GebrauchsanweisungŘiďte se návodem k použití

REF LOT

MaterialMateriał

МатериалMaterialMaterialMateriál

QuantityIlość

КоличествоCantidadMenge

Množství

Use byUżyć do

Срок годностиFecha de caducidad

Verwenden bisPoužijte do

Mat: Qty:Caution

OstrzeżenieПредупреждение

AdvertenciaVorsichtVarování

0197

ISO 9001/ ISO 13485


REUSABLE ORTHOPAEDIC AND SURGICAL INSTRUMENTS

NONSTERILE

Instruments manufactured by ChM sp. z o.o. are made of steel, aluminium al-loys 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 according to recommendations provided below.MATERIALS

Devices are produced of corrosion-resistant steel. The protective layer (passive layer) against corrosion is formed on the surface of the 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 screwdrivers, awls or wrenches, etc. The pro-tective oxide layer, which may be dyed or stay in natural colour (silvery-grey), is formed on the aluminium as an effect of electrochemical 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 the following plastics: POM-C (Polyoxymeth-ylene 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-disinfecting agents with pH val-ues from 4 to 9.5.•If the material of the device cannot be specified, please contact ChM sp. z o.o. company

representative.DISINFECTION AND CLEANING

Effective cleaning is a complicated procedure depending on the following fac-tors: the quality of water, the type and the quality of used detergent, the technique of cleaning (manual/machine), the correct rinsing and drying, the proper preparation of the instrument, the time, the temperature. Internal procedures of sterilization rooms, recommendations of cleaning and disinfecting agents, as well as recommendations for cleaning and sterilization in automatic machines shall be observed.•Read and follow the instructions and restrictions specified by the manufacturers

of the agents used for disinfection and cleaning procedures.1. Before the first use, the product has to be thoroughly washed in the warm wa-

ter with washing-disinfecting detergent. It is important to follow the instructions and restrictions specified by the producer of those detergents. It is recommended to use water solutions of cleaning-disinfecting 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 neutral pH (with disinfecting properties) normally used for reusable medical devices (remember to pre-vent drying out of any organic remains on the product surface). Follow all the instruc-tions specified by the producer of those enzyme detergents.

3. Carefully scrub/clean the surfaces and crevices of the product using a soft cloth with-out leaving threads, or brushes made of plastic, the nylon brushes are recommend-ed. Do not use brushes made of metal, bristles or another damaging material as they can cause physical or chemical corrosion.

4. Next, thoroughly rinse the instrument under the warm running water, paying partic-ular attention to rinse the slots carefully. Use nylon brushes making multiple moves back and forth on the surface of the product. It is recommended to rinse under de-mineralized 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 (e.g. an-odized one). During the rinsing, manually remove the adherent remains.

5. Visually inspect the entire surface of the product to ensure that all contaminants 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 recommended for reusable medical de-vices and instruments).•Procedure of washing with the washer-disinfector shall be performed according to in-

ternal hospital procedures, recommendations of the washing machine manufacturer, and instructions for use prepared by the washing-disinfecting agents manufacturer.ATTENTION! The manufacturer does not recommend using any preservatives on surgi-

cal and orthopedic devices.

STERILIZATIONBefore each sterilization procedure and application, the device has to be con-

trolled. The device is to be efficient, without toxic compounds like residues after disin-fection and sterilization processes, without structure damage (cracks, fractures, bend-ing, peeling). Remember that sterilization is not a substitute for cleaning process!•Devices manufactured out of plastics (PEEK, PTFE, POM-C) may be sterilized by any oth-

er available sterilization method validated in the centre but the sterilization tempera-ture is not to be higher than 140°C.Sterilization of surgical instruments shall be carried out using appropriate equip-

ment and under the conditions that conform to applicable standards. It is recommend-ed to sterilize in steam sterilizers where sterilizing agent is water vapour. Recommend-ed parameters of the sterilization method:

- temperature: 134°C, -pressure: 2 atm. of pressure above atmospheric (overpressure), -minimum exposure time: 7 min, -minimum drying time: 20 min.

Validated sterilization methods are allowed. Durability and strength of instruments to a considerable degree depend on how they are used. Careful usage consistent with intended use of the product protects it against damage and prolongs its life.

If this instruction appears unclear, please contact the manufacturer, who shall provide all required explanations.

Updated INSTRUCTIONS FOR USE are available on the following website: www.chm.eu

IFU-I-001/14; Date of verification: September 2014

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

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

4 INTRAMEDULLARY OSTEOSYNTHESIS OF HUMERUS6 INTERMEDULLARY OSTEOSYNTHESIS OF FEMUR BY TROCHANTERIC

NAILS7 INTRAMEDULLARY OSTEOSYNTHESIS OF FIBULA AND FOREARM8 DYNAMIC HIP (DSB) CONDYLAR (DSK) STABILIZER9 SPINE STABILIZATION10 EXTERNAL FIXATOR15 TIBIAL AND FEMORAL ANGULAR SET BLOCK17 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMORAL AND TIBIA

TELESCOPIC NAIL20 RADIAL HEAD PROSTHESIS KPS21 OPENING WEDGE OSTEOTOMY22 LOCKING PLATES23 OSTEOSYNTHESIS OF FEMUR REVERSED METHOD (condylar approach)24 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR25 INTRAMEDULLARY OSTEOSYNTHESIS OF TIBIA27 INTRAMEDULLARY OSTEOSYNTHESIS OF TIBIA (retrograde method)28 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR WITH TROCHANTERIC

ChFN NAILS29 CERVICAL LOCKING PLATE SYSTEM30 PROXIMAL HUMERAL PLATE31 THE FEMORAL PLATES32 4.0 ChLP PLATES FOR DISTAL PART OF RADIAL BONE

34 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR WITH ANATOMIC FEMUR NAILS

35 SPINE STABILIZATION36 ChLP SCREWS REMOVING37 STABILIZATION OF THE PUBIC SYMPHYSIS38 INTRAMEDULLARY TIBIA OSTEOSYNTHESIS WITH CHARFIX2 NAILS39 IDS SYSTEM40 INTERVERTEBRAL CAGES PLIF PEEK CAGE42 STERNO-COSTAL PLATE43 INTRAMEDULLARY OSTEOSYNTHESIS OF HUMERUS45 RECONSTRUCTION PLATES - PELVIS FIXATION46 INTRAMEDULLARY OSTEOSYNTHESIS OF TIBIA (retrograde method)47 LOCKING PLATES 5.0ChLP48 LOCKING PLATES 7.0ChLP49 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR WITH CONDYLAR NAIL52 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR WITH TROCHANTERIC

NAILS54 ALIF PEEK INTERVERTEBRAL LOCKING CAGES55 ELASTIC INTRAMEDULLARY NAIL FOR CHILDREN56 TLIF PEEK INTERVERTEBRAL CAGES57 5.0ChLP STRAIGHT LOCKING PLATE58 7.0ChLP STRAIGHT LOCKING PLATE59 DISTAL TIBIA TARGETER CHARFIX60 DISTAL TIBIA TARGETER CHARFIX2

instruction - K2 MEDICAL IMPORT

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