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IMPLANTS • INSTRUMENT SET • SURGICAL TECHNIQUE • instruction RADIAL HEAD PROSTHESIS KPS 0197 ISO 9001 ISO 13485 20B

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Page 1: instruction - Rimanere · 4 40.52 5.000 Chwytak trzpienia endoprotezy gkp Rhb prosthesis stem holder Держатель стержня эндопротеза ГЛК 1 ... The above

IMPLANTS •INSTRUMENT SET •

SURGICAL TECHNIQUE •

instruction

RADIAL HEAD PROSTHESIS KPS

0197ISO 9001ISO 13485

20B

Page 2: instruction - Rimanere · 4 40.52 5.000 Chwytak trzpienia endoprotezy gkp Rhb prosthesis stem holder Держатель стержня эндопротеза ГЛК 1 ... The above
Page 3: instruction - Rimanere · 4 40.52 5.000 Chwytak trzpienia endoprotezy gkp Rhb prosthesis stem holder Держатель стержня эндопротеза ГЛК 1 ... The above

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

tel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

TABLE OF CONTENT

Edition 20B of 09.04.2010. The last review on 02.08.2010.

I. INTRODUCTION .......................................................................................................................................................... 5

II. INDICATIONS AND CONTRAINDICATIONS FOR RADIAL HEAD REPLACEMENT .............................................. 5

III. IMPLANTS ................................................................................................................................................................. 6

IV. INSTRUMENTS ......................................................................................................................................................... 7

V. SURGICAL TECHNIQUE .......................................................................................................................................... 10

V.1. Surgical approach to the radiohumeral joint ................................................................................................. 10

V.2. Prosthesis implantation .................................................................................................................................11

V.3. Prosthesis removal ....................................................................................................................................... 14

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Page 5: instruction - Rimanere · 4 40.52 5.000 Chwytak trzpienia endoprotezy gkp Rhb prosthesis stem holder Держатель стержня эндопротеза ГЛК 1 ... The above

5ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLAND

tel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

INTRODUCTION

II. INDICATIONS AND CONTRAINDICATIONS FOR RADIAL HEAD REPLACEMENT

Indications for the radial head replacement in the case of comminuted fracture (Type III according to Mason Classifi cation) are the following coexisting injuries:

• dislocation of the elbow joint together with radial head fracture; • injury of the medial collateral ligament;• injury of the lateral collateral ligament;• Monteggia type injury with the olecranon fracture and the radial head fracture;• fracture of the major part of the coronoid process (Types II and III);• coexisting injury of the distal radioulnar joint (Essex-Lopresti type) or injury of the interosseus membrane;• As a combination of the above - complex injury and instability.

A cotraindication for radial head replacement is an injury of the articular cartilage of the humerus capitulum.

I. INTRODUCTION

The radial head is an essential anatomical and biomechanical element of the elbow joint. Signifi cant restriction of elbow joint move-ment can be a reason of high percentage of disability especially for patients who have professions requiring precise movements.

In the case of multifragmental radial head fracture, radial head resection is still perform, but many complications are observed after this operation. The indication for radial head replacement is a multifragmental, comminuted fracture of the radial head where stable osteosynthesis is not possible.

The presented prostheses are made of cobalt alloy and UHMWPE polyethylene in accordance with ISO 58�2 and ISO 58�4 stan-dards. High quality of the prostheses is confi rmed by Quality Management System ISO 9001, EN ISO 13485 and by meeting the requirements of 9�/42/EEC Directive.

Implants and the instrumentarium have been developed in cooperation with Professor S. Pomianowski Head of the Department of Orthopaedy and Traumatology Post Graduate Medical Center in Otwock.

System for radial head replacement consists of:• implants,• instrumentarium set,• instructions of surgical techniques.

The radial head prosthesis KPS is a bipolar implant; the stem is connected to the head as a socket joint, which enables the prosthesis head to rotate and tilt 15° against the stem axis in both direc-tions. Total range of tilting is �0°.

The prosthesis stem has a collar which should rest against a stump of the radial neck which has been cut during surgery.

The prosthesis head has convex, “barrel-shaped” exterior lateral surface to contact concave surfa-ce of the radial notch of the ulna. From above the surface is concave to contact convex shape of the humerus capitulum.

30°

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6ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLAND

tel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

IMPLANTS

III. IMPLANTS

Radial head prosthesis consists of:

The radial head prosthesis components are packed in separate sterile packages and are put together during surgical procedure.

Nr katalogowy,Catalogue no., № по кат.

H [mm] Ø20 Ø22 Ø24

10 7.�696.010 7.�697.010 7.�698.010

12 7.�696.012 7.�697.012 7.�698.012

14 7.�696.014 7.�697.014 7.�698.014

Głowa lita endoprotezy głowy kości promieniowejSolid head of radial head prosthesisСплошная головка эндопротеза головки лучевой кости

Trzpień endoprotezy głowy kości promieniowejStem of radial head prosthesisСтержень эндопротеза головки лучевой кости [4.3690.000]

Kątowy trzpień endoprotezy głowy kości promieniowejAngular stem of radial head prosthesisНожка угловая эндопротеза головки лучевой кости[4.3691.000]

H

Ø

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7

Lp.Nr katalogowyCatalogue no.

№ по кат.Nazwa Name Название

Szt.PcsШт.

1 40.52�2.000 Raszpla kości promieniowej Radial bone rasp Рашпиль для лучевой кости 12 40.52��.000 Pilnik wygięty prostokątny Rectangular curved fi le Напильник костный изогнутый, прямоугольный 1

� 40.52�4.000 Dopychacz trzpienia endoprotezy gkp Rhb prosthesis stem impactor Импактор для стержня эндопротеза головки лучевой кости ГЛК 1

4 40.52�5.000 Chwytak trzpienia endoprotezy gkp Rhb prosthesis stem holder Держатель стержня эндопротеза ГЛК 15 40.52�6.000 Przymiar głowy kości promieniowej Radial head bone gauge Мера образцовая головки лучевой кости 16 40.52�7.010 Przymiar głowy endoprotezy gkp 20H10 Rhb head prosthesis trial 20H10 Мера образцовая головки эндопротеза ГЛК 20H10 17 40.52�7.012 Przymiar głowy endoprotezy gkp 20H12 Rhb head prosthesis trial 20H12 Мера образцовая головки эндопротеза ГЛК 20H12 18 40.52�7.014 Przymiar głowy endoprotezy gkp 20H14 Rhb head prosthesis trial 20H14 Мера образцовая головки эндопротеза ГЛК 20H14 19 40.52�8.010 Przymiar głowy endoprotezy gkp 22H10 Rhb head prosthesis trial 22H10 Мера образцовая головки эндопротеза ГЛК 22H10 1

10 40.52�8.012 Przymiar głowy endoprotezy gkp 22H12 Rhb head prosthesis trial 22H12 Мера образцовая головки эндопротеза ГЛК 22H12 111 40.52�8.014 Przymiar głowy endoprotezy gkp 22H14 Rhb head prosthesis trial 22H14 Мера образцовая головки эндопротеза ГЛК 22H14 112 40.52�9.010 Przymiar głowy endoprotezy gkp 24H10 Rhb head prosthesis trial 24H10 Мера образцовая головки эндопротеза ГЛК 24H10 11� 40.52�9.012 Przymiar głowy endoprotezy gkp 24H12 Rhb head prosthesis trial 24H12 Мера образцовая головки эндопротеза ГЛК 24H12 114 40.52�9.014 Przymiar głowy endoprotezy gkp 24H14 Rhb head prosthesis trial 24H14 Мера образцовая головки эндопротеза ГЛК 24H14 1

15 40.5240.000 Podstawka przymiarów głów endoprotez Stand for head prosthesis trials Подставка для образцовых мер головок эндопротезов 1

16 40.5242.100 Prowadnica do resekcji Resection guide Направитель для резекции 117 40.5242.200 Prowadnica do resekcji RECON Reconstructive rescection guide Направитель реконструктивны для ресекции 118 40.5249.000 Statyw do endoprotez gkp Stand for rhb prostheses Штатив для зндопротезов ГЛК 1

Instrumentarium do endoprotez gkpInstruments for radial head prosthesesИрструменты для эндопротеза головки лучевой кости[40.5231]

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

INSTRUMENTS

IV. INSTRUMENTS

The instruments for radial head replacement and radial head prosthesis removal [40.5231].

The instrument set comprise the following tools:

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8

Chwytak trzpienia endoprotezy gkpRhb prosthesis stem holderДержатель стержня эндопротеза ГЛК[40.5235.000]

4.

Pilnik wygięty prostokątnyRectangular curved fi leНапильник костный изогнутый, прямоугольный[40.5233.000]

2.

Raszpla kości promieniowejRadial bone raspРашпиль для лучевой кости[40.5232.000]

1.

Dopychacz trzpienia endoprotezy gkpRhb prosthesis stem impactorИмпактор для стержня эндопротеза головки лучевой кости ГЛК[40.5234.000]

3.

Przymiar głowy kości promieniowejRadial head bone trialМера образцовая головки лучевой кости[40.5236.000]

5.

6.-14. Przymiar głowy endoprotezy gkpRhb head prosthesis trialМера образцовая головки эндопротеза ГЛК

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

INSTRUMENTS

H

Ø

Ø [mm] H [mm]Nr katalogowy,Catalogue no.,

№ по кат.

20 10 40.52�7.01020 12 40.52�7.01220 14 40.52�7.01422 10 40.52�8.01022 12 40.52�8.01222 14 40.52�8.01424 10 40.52�9.01024 12 40.52�9.01224 14 40.52�9.014

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9

Statyw do endoprotez gkpStand for rhb prosthesesШтатив для эндопротезов ГЛК[40.5249.000]

18.

Podstawka przymiarów głów endoprotezStand for head prosthesis trialsПодставка для образцовых мер головок эндопротезов[40.5240.000]

15.

Stosować dla, Apply for, Применять для

Nr katalogowyCatalog ue no.

№ по кат.

Trzpień endoprotezyStem of prosthesis

Ножка эндопротезаH

głowy endoprotezyof prosthesis head

головки эндопротеза

40.5242.100Trzpień endoprotezy głowy kości promieniowej

Stem of radial head prosthesisНожка эндопротеза головки лучевой кости

4.�690.000 10

12

14

nastawnyadjustable

устанавливаемый

40.5242.200Kątowy trzpień endoprotezy głowy kości promieniowej

Angular stem of radial head prosthesisНожка угловая эндопротеза головки лучевой кости

4.�691.000

Prowadnica do resekcjiResection guideНаправитель для резекции[40.5242.100]

16. Prowadnica do resekcji rekon.Resection guide recon.Направитель реконструктивны для ресекции[40.5242.200]

17.Prowadnica do resekcjiResection guideНаправитель для резекции[40.5242.100]

16. Prowadnica do resekcji rekon.Resection guide recon.Направитель реконструктивны для ресекции[40.5242.200]

17.

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

INSTRUMENTS

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10

a

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

SURGICAL TECHNIQUE

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

V. SURGICAL TECHNIQUE

Surgical technique have been developed in cooperation with Professor S. Pomianowski Head of the Department of Orthopaedy and Traumatology Post Graduate Medical Center in Otwock. The experience of the medical center as well as the experience of the surgeon are the most important things regarding the treatment method.

V.1. Surgical approach to the radiohumeral joint

Operation should be performed in Esmarch’s clamp.Anterior-lateral operative approach should be used.Straight skin incision are made 1cm above the lateral epicondylus of the humerus down 2cm distal from palpable radial head. Incision is 8-10cm long. It is advised to mark osseous points: the lateral epicondylus of the humerus, the head of the radius, and the top of the olecranon. After skin and subcutaneous tissue incision, expose the fascia (pic. a). After it has been cut, partially release the origin of the brachioradialis muscle for approx. 2cm. Then go forward between both carpi radialis extensors muscles and common extensor digitorum tendon. While making the approach, assistant should pronate forearm. This manoeuvre allows the posterior interosseous nerve (the deep branch of the radial nerve) to be away from the incision line by approximately 1cm. Next, incise the joint capsule and the proximal part of the annular ligament unless is damaged. Next, open the radiohumeral joint, above the lateral collateral li-gament complex and its origin. The origin is located in the central point of curvature of the humerus capitulum from the lateral side. Expose antero-lateral-part of the humerus capitulum and the head of the radius. Due to radial head fracture humerus capitulum is a better reference point than radial head. From the joint side pla-ce Langenbecks’s elevator up to the anterior surface of the distal humerus. Next, place the second Langenbecks’s elevator behind the remaining part of the radial head. If fragments of the head are displaced, they should be found and removed. Keep pro-nated forearm and incise the distal part of the annular ligament exposing the neck of the radius from the lateral side. Carefully remove tissue with raspatory from lateral and anterior surfaces of the neck, place Langenbecks’s elevator behind it. Remove all remaining fragments of the radial head.

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11

2a

1

2

2b

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

SURGICAL TECHNIQUE

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

V.2. Prosthesis implantation

Fragments of the radial head should be put together into the radial gauge [40.5236.000] fi tting head diameter

to a hollow in the gauge. Do this on the operating table. Select appropriate prosthesis head.

111

Carefully rinse the joint in physiological saline.

Using the resection guide measure the distance from the be-ginning of the radial notch of the ulna to the stump of the neck of the radius. The resection guides are intended for measurement this distan-ce, because it is the same as a prosthesis head height:

• the resection guide [40.5242.100] - stem [4.3690.000],• the resection guide [40.5242.200] - angular stem [4.3691.000].

Check this distance one again and pick up the closest size (height) of the implant head.

222

OPTIONThe fractures of radial head extended to fractures

of the radial head’s neck should be supplied with the angular stem [4.3691.000], which construction allows reconstruction of the anatomical neck deviation in respect to the bone axis.In this case the neck should be resected just above the tuberos-ity of radius. Resect the stump using the resection guide recon. [40.5242.200], set to the size of chosen prosthesis head.Using the resection guide recon. measure the distance from the proximal end of the radial notch of the ulna to the stump of the neck of the radius. Choose the suitable size of the prosthe-sis head based on the measured distance and the measurement of removed radial head diameter.

2b2b2b

It is necessary to resect the stump with a value, which will fi t with the closest size (height) of the radial head.

Resect the stump of the neck straight and measure the mentio-ned distance once again. Choose the suitable size of the pros-thesis head based on the measured distance, as well as measu-rement of removed radial head diameter.

2a2a2a

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12

3

4

5a

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

SURGICAL TECHNIQUE

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

Using a rectangular curved fi le [40.5234.000] make the stump of the radial neck smoother.

444

Insert an elevator behind the neck of the radius and identi-fy the bone marrow canal using a “frim” or a thin

Wolszczan’s chisel. Next, using a reamer, a curette, and fi nally a rasp [40.5232.000] prepare the canal for implantation of the stem of the prosthesis. The canal should be wider by 0,5mm at both sides of the stem and longer than the stem by at least 0,5cm. Plug the marrow ca-nal with a bone block excised from the spongy portion of the re-moved radial head. Carefully rinse the canal

If the angular stem is used, penetrate the rasp [40.5232.000] to the marker signed RECON.If the standard stem is used, penetrate the rasp to the end of its fi ling part.

333

If the angular stem is used, pass over the 5a and 5b steps, because collarless stem construction makes impossible to carry them out.

First insert the stem [4.3690.000] into previously prepared canal of the radial neck, and then put on it appropriate trial

of prosthesis head. Select diameter and height of the trial based on previous measurements (see stage 1 and 2).

5a5a5a

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1�

5b

6

7

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

SURGICAL TECHNIQUE

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

The collar of the stem should rest perfectly on the stump of the ra-dial neck. Check the joint stability and whether the head of pros-

thesis trial centers well on the humerus capitulum. Check the range of movement of the elbow joint: fl exion, extension and rotation.

5b5b5b

Carefully rinse the joint and then implant the stem [4.3690.000] using bone cement.

Using the stem impactor [40.5234.000] carefully push the pros-thesis stem until the bone cement has bonded. Next, put on the stem the appropriate prosthesis head. To put the head of the implant on the stem slightly “stick out” the radial bone side-ways, which can be done without realising the origin of the lateral collateral ligament complex.This can be easily done because, fi rstly, the stem of the im-plant is relatively short and, secondly, because it is much easier to place the stem into the marrow cavity and then put the head of the implant on it. It is due to modular and bipolar structure of the implant.

During the implantation of the angular stem, position the stem in line with anatomical radial neck deviation and then softly push until the bone cement would be bonded.

666

Rinse the joint and fi t on Redon’s drain.

It is recomended to put 2 mattress sutures on previously partially released the origin of the brachioradialis muscle. Next, put on 2 or � sutures on the annular ligament; if it is seriously injured then stitch the articular capsule trying to “close” the joint. Sutures on fascia, subcutaneous tissue, and skin fi nish the operative proce-dure. Put on a “cocoon” type sterile dressing with a thick layer of cotton and elastic bandage. There is no need to apply a pla-ster cast.Put the limb in an elevated position and after the procedure check blood supply, sensation and fi ngers movements.

777

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14

8

ChM Ltd., Lewickie �b, 16-061 Juchnowiec K., POLANDtel. +48 85 71�-1�-20 ÷ 25 fax +48 85 71�-1�-19 e-mail: [email protected]

SURGICAL TECHNIQUE

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

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.

V.3. Prosthesis removal

In a case of infection of soft tissues around the implant it is recommended to remove the implant without performing

reimplantation. In case of implant damage (e.g. disconnection of prosthesis components) reimplantation of all components of the prosthesis is recommended (the stem and the head of prosthesis).

Using the same surgical approach remove the head of prosthesis (stage1), and then remove the stem. Do it using Rhb prosthesis stem holder [40.5235.000].

The tool is designed in order to grab and pull with little strenght with simultaneous tapping bone cement between the collar of the prosthesis stem and the stump of the radial neck using an appriopriate chisel (a surgeon performing the operative choses an appropriate tool).

Pay special attention not to damage the radius and other stru-ctures of the elbow joint. After stem removal from the marrow cavity remove also all bone cement using a special hook and chi-sel (a surgeon performing the operative choses an appropriate tool).

888

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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.

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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 humerus7 Intramedullary osteosynthesis of fibula and forearm6 Intermedullary osteosynthesis of femur by trochanteric nails8 Dynamic Hip (DSB)/ Condylar (DSK) stabilizer9 Spine stabilization CHARSPINE

15 Tibial and femoral angular set block20 Radial Head Prosthesis KPS22 Locking plates23 Intramedullary osteosynthesis of femur (reversed method) 40.366024 Intramedullary osteosynthesis of femur 40.5060.00025 Intramedullary osteosynthesis of tibia 40.5370.50028 Intramedullary osteosynthesis of femur by trochanteric nail - ChFN29 Cervical locking plate system30 Proximal humeral plate31 Femoral plates32 4.0 ChLP plates for distal part of radial bone35 Spine stabilization [6mm]36 ChLP screws removing37 Stabilization of the pubic symphysis38 Intramedullary tibia osteosynthesis with ChTN nails