ChM CHARFIX system Manuale utente

ChM sp. z o.o.

Lewickie 3b

16-061 Juchnowiec Kościelny

Poland

tel. +48 85 86 86 100

fax +48 85 86 86 101

[email protected]

www.chm.eu

0197 www.chm.eu

IFU-001/07.19

INTERLOCKING NAIL SYSTEM 3

SYSTEM GWOŹDZI BLOKOWANYCH 13

СИСТЕМА БЛОКИРУЕМЫХ СТЕРЖНЕЙ 24

SISTEMA DE CLAVO DE INTERBLOQUEO 36

VERRIEGELUNGSNAGELSYSTEM 47

SYSTÉM HŘEBŮ S PEVNOU FIXACÍ 58

SISTEMA DI CHIODI AD INCASTRO 68

Charfix Femoral Nail

SYMBOL TRANSLATION• OBJAŚNIENIA SYMBOLI•

ПОЯСНЕНИЕ ОБОЗНАЧЕНИЙ• EXPLICACIÓN

DE LOS SÍMBOLOS• SYMBOLERKLÄRUNG•

SYMBOLY PŘEKLADY•TRADUZIONE SIMBOLI

Do not reuse• Nie używać powtórnie• Не

использовать повторно• No reutilizar• Nicht

wiederverwenden• Nepoužívejte opakovaně•

Non riutilizzare

Do not resterilize• Nie sterylizować ponownie•

Не стерилизовать повторно• No reesterilizar•

Nicht resterilisieren• Nepoužívejte resterilizaci•

Non risterlilizzare

Do not use if package is damaged• Nie używać jeśli

opakowanie jest uszkodzone• Не использовать при

повреждённой упаковке• No utilizar si el envase está

dañado• Nicht verwenden falls Verpackung beschädigt

ist• Nepoužívejte, pokud je obal poškozen• Non

utilizzare se la confezione é danneggiata

Consult Instructions for Use• Zajrzyj do instrukcji

używania• Обратитесь к инструкции по

применению• Consultar instrucciones de uso• Siehe

die Gebrauchsanweisung• Řiďte se návodem k použití•

Consultare le instruzioni per l'uso

NON

STERILE

Non-sterile• Niesterylny• Не стерильно• No estéril•

Unsteril• Nesterilní• Non sterile

Caution• Ostrzeżenie• Осторожно• Advertencia•

Vorsicht•Varování• Avvertenza

STERILE R

Sterilized using irradiation• Sterylizowany przez

napromieniowanie• Радиационная стерилизация•

Esterilizado mediante radiación• Sterilisiert durch

Bestrahlung• Sterilizovat zářením• Sterilizzato

mediante irradiazione

STERILE VH202

Sterilized using hydrogen peroxide• Sterylizowany

nadtlenkiem wodoru• Стерилизован перекисью

водорода• Esterilizado con peróxido de hidrógeno•

Sterilisiert mit Wasserstoperoxid• Sterilizováno s

peroxidem vodíku• Sterilizzato mediante perossido

di idrogeno

REF

Catalogue number• Numer katalogowy• Номер по

каталогу• Número de catálogo• Katalognummer•

Katalogové číslo• Numero di catalogo

LOT

Batch code• Kod partii• Код партии• Código de lote•

Chargennummer• Číslo šarže• Codice del lotto

Mat:

Material• Materiał• Материал• Material• Material•

Materiál• Materiale

Qty:

Quantity• Ilość• Количество• Cantidad• Menge•

Množství• Quantita'

Use by• Użyć do• Использовать до• Usar antes de•

Verwenden bis• Použijte do• Da utilizzare entro il

SYMBOL TRANSLATION• OBJAŚNIENIA SYMBOLI•

ПОЯСНЕНИЕ ОБОЗНАЧЕНИЙ• EXPLICACIÓN

DE LOS SÍMBOLOS• SYMBOLERKLÄRUNG•

SYMBOLY PŘEKLADY•TRADUZIONE SIMBOLI

Do not reuse• Nie używać powtórnie• Не

использовать повторно• No reutilizar• Nicht

wiederverwenden• Nepoužívejte opakovaně•

Non riutilizzare

Do not resterilize• Nie sterylizować ponownie•

Не стерилизовать повторно• No reesterilizar•

Nicht resterilisieren• Nepoužívejte resterilizaci•

Non risterlilizzare

Do not use if package is damaged• Nie używać jeśli

opakowanie jest uszkodzone• Не использовать при

повреждённой упаковке• No utilizar si el envase está

dañado• Nicht verwenden falls Verpackung beschädigt

ist• Nepoužívejte, pokud je obal poškozen• Non

utilizzare se la confezione é danneggiata

Consult Instructions for Use• Zajrzyj do instrukcji

używania• Обратитесь к инструкции по

применению• Consultar instrucciones de uso• Siehe

die Gebrauchsanweisung• Řiďte se návodem k použití•

Consultare le instruzioni per l'uso

NON

STERILE

Non-sterile• Niesterylny• Не стерильно• No estéril•

Unsteril• Nesterilní• Non sterile

Caution• Ostrzeżenie• Осторожно• Advertencia•

Vorsicht•Varování• Avvertenza

STERILE R

Sterilized using irradiation• Sterylizowany przez

napromieniowanie• Радиационная стерилизация•

Esterilizado mediante radiación• Sterilisiert durch

Bestrahlung• Sterilizovat zářením• Sterilizzato

mediante irradiazione

STERILE VH202

Sterilized using hydrogen peroxide• Sterylizowany

nadtlenkiem wodoru• Стерилизован перекисью

водорода• Esterilizado con peróxido de hidrógeno•

Sterilisiert mit Wasserstoperoxid• Sterilizováno s

peroxidem vodíku• Sterilizzato mediante perossido

di idrogeno

REF

Catalogue number• Numer katalogowy• Номер по

каталогу• Número de catálogo• Katalognummer•

Katalogové číslo• Numero di catalogo

LOT

Batch code• Kod partii• Код партии• Código de lote•

Chargennummer• Číslo šarže• Codice del lotto

Mat:

Material• Materiał• Материал• Material• Material•

Materiál• Materiale

Qty:

Quantity• Ilość• Количество• Cantidad• Menge•

Množství• Quantita'

Use by• Użyć do• Использовать до• Usar antes de•

Verwenden bis• Použijte do• Da utilizzare entro il

INSTRUCTIONS FOR USE

Important product information for

INTERLOCKING NAIL SYSTEM

Charfix Femoral Nail

1 PURPOSE AND INDICATIONS

1. Bone nails of CHARFIX, CHARFIX2, ChFN, ChFN2 systems are intended

for osteosynthesis of long bone fractures.There are the following indica-

tionsforbone treatment: transverse and shortoblique fractures,trochan-

teric zone fractures (per-, inter-, sub-trochanteric), comminuted fractures,

open fractures of I, II, IIIA degree Gustillo-Anderson, pathologic fractures,

disturbanceof union (falsejoint) aftertreatmentusing othermethods,cor-

rective osteotomies, neck base region fractures. Bone nails of CHARFIX FN

system and femoro-tibial nails are used to treat diseases associated with

the knee joint, in particular: failed arthroplasty, periprosthetic fractures,

post-traumatic state which does not allow for implantation of the knee

prosthesis,post-infectionstate,neoplastictransformations,lossof ordam-

age to the knee extensor, knee arthrodesis.

2. Bone nail locking elements: locking screws, reconstruction screws, lock-

ing sets, setting screws, compression screw, join screws, end cap, spiral

screw and nuts, are used to lock the nails of the above-mentioned sys-

tems in the treatment of long bone fractures by means of intramedul-

lary xation method.

3. Stableosteosynthesisofbone fragmentsisobtained by locking the appro-

priatenail inthemedullarycanal with the useoflocking elements suitable

for the given nail and xation method used.

4. Nailsandtelescopic sleeves areintendedfor fracture treatmentin children

and adolescents with congenital osteogenesis imperfecta.

5.Calcaneal nail ofCHARFIX2 system is usedto treatfractures ofthecalcaneus

and for subtalar arthrodesis.

6. When using CHARFIX2 FN nails combined with knee joint resection, use

spacers.

7. The radial nail is intended for treatment of distal radius fractures.

8. For the implantation of the aforementioned products, ChM’s specialist

instrument sets are dedicated. Along with the instrument set, illustrated

surgicaltechniqueis also provided.Surgical technique isnota detailed in-

structionof conduct.Thisis the physician that determinesthe proper tech-

nique and detailed surgical procedure for a particular patient.

2 CONTRAINDICATIONS

1. Contraindications may be relative or absolute. The choice of particular

device must be carefully considered in terms of patient’s overall condi-

tion. Conditions listed below may preclude or reduce the chance of suc-

cessful outcome:

1) Infection local to the operative site.

2) Signs of local inammation.

3) Fever or leukocytosis.

4) Pregnancy.

5) Neuromuscular disorders which can create unacceptable risk of xation

failure or complications in postoperative care.

6) Any other condition which would preclude the potential benefit

of implant application and may disturb the normal process of bone

remodeling, e.g. the presence of tumours or congenital abnormalities,

fracture local to the operating site, elevation of sedimentation rate un-

explainedby otherdiseases,elevationof whiteblood cells (WBC) count,

or a marked left shift in the WBC dierential count.

7) Suspected or documented allergy or intolerance to implant materials.

Surgeonshallnd out ifthepatientdevelopsallergicreaction tothema-

terial of the implant (content of the implant material is presented in IM-

PLANT MATERIAL).

8) Any case not needing a surgical intervention.

9) Any case not described in the indications.

10) 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.

11) Anycase where the implant components selectedfor use wouldbe too

large or too small to achieve the successful result.

12) Anycase that requiresthe simultaneous use ofelements from dierent

systems that are made of dierent metals.

13) Any case in which implant utilization would disturb physiological

processes.

14) Blood supply limitation in the operative site.

15) Morbid obesity (dened according to the WHO standards).

16) Any case in which there is inadequate tissue coverage of the opera-

tive site.

17) Shaft fractures with a ssure less than 5 cm from the nearest inter-

locking hole of the nail.

2. The above-mentioned list of contraindications is not exhaustive.

3 ADVERSE EFFECTS

1. The adverse eects may necessitate reoperation or revision. The sur-

geon should warn the patient about the possibility of adverse eects

occurrence.

2.The below-mentioned list ofadverseeventsis not exhaustive.There is a risk

of occurrence of adverse events with unknown aetiology which may be

caused by many unpredictable factors.

3. Potential adverse events include but are not limited to:

1) Implant damage (fracture, deformation or detachment).

2) Early or late loosening, or displacement of the implant from the ini-

tial place of insertion.

3) Possibility of corrosion as a result of contact with other materials.

4) Body reaction to implants as to foreign bodies e.g. possibility of tumour

metaplasia, autoimmune disease and/or scarring.

5) Compression on the surrounding tissues or organs.

6) Infection.

7) Bone fractures or “stress shielding”phenomenon causing loss of bone

above, below or at the operative site.

8) Haemorrhage and/or hematomas.

9) Pain.

10) Inability to perform everyday activities.

11) Mental condition changes.

12) Death.

13) Deep vein thrombosis, thrombophlebitis.

14) Occurrenceof respiratory complications, e.g.: pulmonaryembolism, at-

electasis, bronchitis, pneumonia, pulmonary infection, disturbed lung

growth, respiratory acidosis, etc.

15) Scar formation that could cause neurological impairment, or nerves

compression and/or pain.

16) Late bone fusion or no visible fusion mass and pseudoarthrosis.

17) Loss of proper curvature and/or length of bone.

4WARNINGS

1. The important medical information provided in this document should

be given to the patient.

2.The selectionof propershape and size oftheimplant appropriatefora spe-

cic patient is crucial to achieve the success of the surgery. The surgeon is

responsible for this choice.

3. Preoperative and operating procedures, including knowledge of surgical

techniques, and correct placement of implants are important and shall

beconsideredby the surgeon inorderto achievesuccess during operation.

4. No implant can withstand body loads without the biomechanical con-

tinuity of the bone.

5. During normal use all surgical implants are subjected to repeated stresses

which can result in material fatigue and failure of the implant.

6. To avoid excessive stress on the implant which could lead to non-union

or implant failure and associated clinical problems, the surgeon must in-

form the patient about the physical activity limitations during the treat-

ment period.

7. Ifthe patient is involvedin anoccupation oractivity(e.g.:substantial walk-

ing, running, weights lifting, muscles strain) which may apply excessive

stresson the implant,the surgeonmust informthe patient that resultant

forces can cause implant failure.

8. A successful result is not always achieved in every surgical case. This fact

is especially true in the case where other patient’s conditions may com-

promise the results.

9. The proper patient selection, compliance of the patient and observance

of post-operative recommendations will greatly affect the results.

The bone union is less likely to occur among smoking patients. These pa-

tientsshouldbe informed aboutthis factandwarnedofthisconsequence.

10. Overweight may cause additional stresses and strains within implant

which can lead to fatigue and deformation of the implant.

11.Patientswhoareoverweight,malnourishedand/or abuse alcoholor drugs,

with weak muscles and low quality bones and/or with nerve palsy are

not the best candidates for the procedure of surgical stabilization. These

patients are not able or not ready to observe the post-operative recom-

mendations and limitations.

12.The implants areintended as anaid tothehealingprocessandareNOT in-

tendedto replace body structuresor bear the body weightwhen the treat-

ment process has not yet nished.

13.The implant maybreak orbecome damaged asa resultofstrenuousactiv-

ity or trauma, and may need to be replaced in the future.

14. The surgeon must warn the patient that the device cannot and does not

restore the function and eciency of a healthy bone.

15. In the case of delayed union or non-union, the load or weight bearing

may eventually cause the implant bending, loosening, disassembling

or fatigue breakage.

16. The surgeon should inform the patient of the resulting total stiening

of the limb when using CHARFIX2 FN implants and femoro-tibial nails.

5 PACKAGING AND STORAGE

1. Implants are single-use devices, provided sterile or non-sterile.

2. Implants not labeled as sterile are non-sterile.

3. Implant packaging must be intact at the time of receipt.

4. Implantscan be deliveredin aunit package.The unit package of the prod-

uct contains:

1) sterile version - one piece of the product in a sterile condition. A dou-

ble packaging made of Tyvek-foil or a single blister are typical pack-

aging material.

2) non-sterile version - one piece of the product. Plastic bags are a typi-

cal packaging material.

5. Implants can be delivered on stands, palettes (non-sterile version only).

6. A sterility indicator is placed on the sterile package.

7. Products are delivered with a label. The label (as a primary label) con-

tains e.g.:

1) Sterile product

a) Logo ChM and the address of the manufacturer.

b) Name and size of the device and its catalogue number (REF), e.g.:

3.XXXX.XXX.

c) Production batch number (LOT), e.g. XXXXXXX.

d) Material of the implant (see IMPLANT MATERIAL).

e) STERILE sign - indicating a sterile device and the sterilization method

used, e.g.: R or VH202 (symbols are described in the footer of this In-

structions For Use).

f) Sterilization batch number, e.g.: S-XXXXXXX.

g) Device pictogram and information symbols (described in the footer

of this Instructions For Use).

h) Expiration date and sterilization method.

2) Non-sterile product

a) Logo ChM and the address of the manufacturer.

b) Name and size of the device and its catalogue number (REF), e.g.:

3.XXXX.XXX.

c) Production batch number (LOT), e.g. XXXXXXX.

d) Material of the implant (see IMPLANT MATERIAL).

e) NON-STERILE sign - indicates non-sterile product.

f) Device pictogram and information symbols (described in the footer

of this Instructions For Use).

8. In addition to the device primary label, an auxiliary label with specic

market requirements of a given area may be placed on the unit pack-

age (e.g. legal requirements of the country in which the device will be

distributed).

9. The package may contain: Instructions For Use and labels to be placed

in a patient’s medical record.

10. Depending on the size or type of the product, the following information

may be marked on its surface: manufacturer’s logo, production batch no.

(LOT), catalogue no. (REF), type of material and device size.

11.Implants should bestoredinappropriateprotectivepackagings,in a clean,

dry place witha roomtemperatureandunder conditions that providepro-

tection from direct sunlight.

6 IMPLANT MATERIAL

1. Identication of the materials

1) Depending on the material used, the following symbols may be marked

on the device surface:

a) Steel: symbol (S).

b) Titanium and titanium alloys: symbol (T).

2) The implants are made of:

a) Implantable stainless steel.

b) Implantable titanium alloy.

3) Percent composition of elements in the implantable materials (max.

values):

a) Titanium alloy according to ISO 5832-3/ASTM F136: | Al:6.75 |V:4.5 |

Fe:0.3 | O:0.2 | C:0.08 | N:0.05 | H:0.015 |Ti:balance.

b)Titanium alloyaccordingto ISO 5832-11/ASTMF1295: | Al:6.5| Nb:7.5|

Ta:0.5 | Fe:0.25 | O:0.2 | C:0.08 | N:0.05 | H:0.009 | Ti:balance.

c) Steel according to ISO 5832-1/ASTM F138: | C:0.03 | Si:1.0 | Mn:2.0 |

P:0.025| S:0.01 |N:0.1 |Cr:19.0 | Mo:3.0| Ni:15.0 | Cu:0.5| Fe:balance.

d) Steel according toISO 5832-9/ASTMF1586: |C:0.08 |Si:0.75 | Mn:4.25

| P:0.025 | S:0.01 | N:0.5 | Cr:22.0 | Mo:3.0 | Nb:0.8 | Ni: 11.0 | Cu:0.25

| Fe:balance.

4) ATTENTION: Implantable titanium, titanium alloy and/or implantable

cobaltalloymay be usedtogetherin the same construct.Neverusetita-

nium,titaniumalloy and/or cobaltalloy withimplantablestainlesssteel

componentsin the same constructasit maylead tocorrosionandreduc-

tion of mechanical strength of implants.

2. Magnetic resonance compatibility

1) ChM’s implants made completely from or containing elements made

of implantable steel werenot assessed for their safetyand compatibility

with magnetic resonance imaging procedures. The performance of MRI

on these implants (especially in the magnetic eld with a signicant in-

duction) may pose a potential risk of, i.a.:

a) implant displacement or heating up,

b) artifacts on MR images.

2) Implants made of titanium, titanium alloys and cobalt alloys are condi-

tionally compatible with magnetic resonance imaging.

3) The patient can be scanned safely under the following conditions:

a) static magnetic eld of ≤ 3 Tesla,

b) maximum magnetic eld spatial gradient of ≤ 720 Gauss/cm,

c)maximum MR systemreportedwhole-body-averagedspecicabsorp-

tion rate (SAR) of 3W/kg for 15 minutes of scanning.

4) CAUTION: the user should be absolutely familiar with the contraindica-

tionsandwarningsestablished bythemanufacturerof the MRIscanner

to be used for imaging procedure.

5) MR imaging may be interfered with if the area of interest is in the exact

same area or relatively close to the position of the implant.

6) Do not perform MRI if there are doubts about the tissue integrity

and the implant xation or if the proper location of the implant is im-

possible to be established.

7 PRE-OPERATIVE RECOMMENDATIONS

1.Only patientsthat meet the criteria describedinthePURPOSE AND INDICA-

TIONS should be selected.

2. Patients’conditions and/or predispositions such as those addressed

in the above-mentioned 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 occurrence after the operation. Patient shall be intro-

duced to the purpose and manner of the procedure, and to functional

and aesthetic eects of such treatment. Proper clinical diagnosis and ac-

curate operation planning and performance are needed to achieve good

nal result of treatment.

4. Where material sensitivity is suspected, appropriate tests should be made

prior to material selection or implantation (alloying elements of implant

material are presented in IMPLANT MATERIAL).

5.The implantation shall becarriedout bythesurgeonfamiliar with adequate

rulesandoperatingtechniques,and whohasacquiredpractical skills ofus-

ing ChM instrument set. The selection of surgical technique adequate

for a specic patient remains surgeon’s responsibility.

6. The operation procedure shall be carefully planned. The size of implant

should be determined prior to the surgery. An adequate inventory of im-

plants with required sizes should be available at the time of surgery, in-

cluding sizes larger and smaller than those expected to be used.

7.Thesurgeon should be familiar with allcomponents of the implant system

beforeuse and should personallyverifyif allcomponents and instruments

are present before the surgery begins.

8. Donot use the implantif the original,sterile packagingis damaged. Steril-

ity cannot be guaranteed if the package is not intact. The package shall

be carefully checked prior to use.

9. Implants are delivered in protective packagings. The package should be

intact at the time of receipt.

10. Unless supplied sterile, all implants and instruments should be washed,

disinfectedandsterilizedbeforeuse.Additionalsterilecomponents should

be available in case of any unexpected need.

11. Before procedure begins, all implants should be carefully checked to en-

sure that there is no damage (surface scratching, dents, signs of corrosion

and shape deformations). Damaged implant must not be inserted into

the body.

8 RECOMMENDATIONS FOR IMPLANTS PROVIDED

STERILE

1. Sterile implant - is delivered in sterile packaging, with the inscription:

“STERILE”. Such product is sterile and the manufacturer is responsible

for the process of sterilization. The sterilization is performed with the use

of one of the following methods:

1) gamma radiation, with a minimum dose of 25 kGy,

2) hydrogen peroxide vapour.

2. The symbol designating the sterilization method used is visible on the de-

vice label (symbols are described in the footer of this Instructions For Use).

3. Prior to use of a sterile device the following rules apply:

1) Check out the expiration date of sterilization. Do not use the device with

an overstepped sterility date!

2) Check out if the sterile package is not damaged. Do not use the device

if the sterile package is damaged!

3)Check out the colour ofthesterility indicator onthesterilepackage which

indicates that sterilization of the device was performed. Do not use

the device if the sterility indicator colour is dierent than:

a) red - for devices sterilized with gamma radiation,

b) blue - for devices sterilized with hydrogen peroxide vapour.

4. CAUTION: products should be removed from their packagings in accor-

dance with aseptic rules.

9 RECOMMENDATIONS FOR IMPLANTS PROVIDED

NON-STERILE

1. The following recommendations apply to unused non-sterile implants.

An implant that has been implanted must not be re-processed and re-

used.

2. The implant which has not been used but got contaminated by contact

with the blood, tissue and/or body uids/materials, should not be used

again. The implant should be handled in accordance with applicable

hospital protocol. ChM does not recommend re-processing of contami-

nated implants. Should the contaminated implant be re-processed, ChM

bears no responsibility.

3. Prior to use of a non-sterile device, the following rules apply:

1) The device must undergo cleaning, disinfection and sterilization pro-

cedures.

2)Eective cleaning isa complicatedproceduredepending onthefollowing

factors: the quality of water, the type and the quantity of used deter-

gent,the technique ofcleaning (manual,automated),the properrinsing

and drying,the properpreparationof the device,the time, the tempera-

ture and carefulness of the person conducting this process.

3)The hospitalfacility remains responsible for the eectivenessofthe con-

ducted cleaning, packaging and sterilization processes with the use

of existing equipment, materials and properly trained personnel.

4. Preparation for washing and disinfection (for all methods)

1) Prior to cleaning, remove the implant from the original unit packaging.

Dispose of the packaging. Protect patient labels, provided with the im-

plant, against accidental loss or damage.

2) To avoid contamination, the implants should not have contact with

the contaminated devices/instruments.

3) Rinse under running water and remove possible surface dirt (resulting

from e.g.: damage to the unit packaging) using adisposable cloth, paper

towel or plastic brushes (nylon brushes are recommended).

4)CAUTION: Itisforbidden touse brushes made ofmetal,bristles ormateri-

als which could damage the implant.

5. Cleaning and disinfection process

1)This InstructionsforUse describes twovalidatedbyChM cleaning and dis-

infection methods: manual with ultrasound cleaning and automated

method. It is recommended to use automated procedures for cleaning

and disinfection (in the washer-disinfector).

2) The chosen washing and disinfecting agents must be suitable and ap-

provedfor use withmedicaldevices.It is importantto followthe instruc-

tionsandrestrictionsspecied bytheproducerof thosecleaning agents.

It is recommended to use aqueous solutions of washing-disinfecting

agentswitha pH valuebetween10.4and10.8. ChM used the following

materials during the validation process of the described recommenda-

tions for cleaning and disinfection. It is allowed to use other materi-

als than those listed below which may also give a comparable eect:

a) detergent - Dr.Weigert (producer) neodisher® MediClean forte (name

of the detergent);

b) disinfectant - Dr.Weigert (producer) neodisher® Septo Active (name

of disinfectant).

3) Manual with ultrasound cleaning

a) Equipment and materials: a device for ultrasound cleaning, soft, lint-

free cloths, plastic brushes, aqueous solutions: of cleaning agent, dis-

infecting agent or washing – disinfecting agent.

b) Prepare an aqueous solution of cleaning agent at temperature

of 40+/-2 °C and a pH of 10.4 - 10.8 (follow the information contained

in the instructions prepared by the manufacturer of the agent, in re-

spect of temperature, concentration, exposure time and water quality).

c) Immerse the implant in the aqueous solution of the cleaning agent

and subject it to ultrasound cleaning for 15 minutes.

d) Rinse the implant thoroughly under running water, paying particular

attention to the holes and places dicult to be cleaned. It is recom-

mended to rinse with demineralized water.

e)Visually inspecttheentiresurface ofthedevice for debrisand impurity.

Damagedimplants must beremoved.For dirty implants, the cleaning

process should be repeated.

f) Dry the device thoroughly using disposable, soft, lint-free cloth.

g) Prepare an aqueous solution of disinfecting agent at a temperature

of 20+/-2 °C using 20g of the agent per 1 liter of water. Immerse

the implant in the solution, exposure time – 15min (follow the in-

formation contained in the instructions prepared by the manufacturer

of the agent, in respect of temperature, concentration, exposure time

and water quality).

h) After the exposure time, rinse the product thoroughly under running

water, paying particular attention to the holes and places dicult

to be cleaned. It is recommended to rinse with demineralized water.

i) Dry the device thoroughly. It is recommended to dry the implant

in a dryer at a temperature ranging from 90°C to 110°C.

j) Visually inspect the entire surface of the device.

4) The automated method using a washer - disinfector

a) Equipment and materials: a washer - disinfector, aqueous solutions

of cleaning agent.

b) CAUTION: The equipment used for washing/disinfection should meet

the requirements of ISO 15883. Procedure of washing in the washer-

disinfector shall be performed according to internal hospital pro-

cedures, recommendations of the washing machine manufacturer,

and Instructions for Use prepared by the washing-disinfecting agent

manufacturer.

c)The device shouldundergoaprocessof machinewashing inthewash-

er-disinfector using the followingcycle parameters: (1) - pre-washing

in cold tap water, duration – 2min; (2) - washing in an aqueous solu-

tion of cleaning agent at 55+/-2 °C and pH of 10.4 - 10.8, duration –

10min; (3) - rinsing under demineralized water, duration – 2min; (4)

- thermal disinfection in demineralised water at 90°C, minimal dura-

tion– 5min; (5) -drying ata temperaturerangingfrom90°C to110°C,

duration - 40min.

6. Packaging

1) Washed and dried devices shall be packed in a packaging intended

for the recommended steam sterilization. The packaging and pack-

aging process have to meet the requirements of ISO 11607 standards.

The packagingproceduremust beperformed incontrolledpurity condi-

tions. The device must be packed in such a way that during its removal

fromthe packaging,when used,there is norisk for itsre-contamination.

7. Sterilization

1) Washed, disinfected, and dried device shall undergo the sterilization

process in accordance with the applicable procedures of the customer.

The recommendedmethodof sterilizationis vacuum-type steamsteril-

ization (with water vapor under overpressure):

a) temperature: 134°C,

b) minimum exposure time: 7 min,

c) minimum drying time: 20 min.

2) CAUTION

a) The sterilization process must be validated and routinely monitored

in accordance with the requirements of EN ISO 17665-1.

b) Sterilization must be eective and in accordance with requirements

of the EN 556-1 standard to ensure the required level of guaran-

teed sterility SAL10-6 (where SAL stands for Sterility Assurance Level).

c) The implant cannot be sterilized in the unit package in which it was

delivered.

d) The method of sterilization using ethylene oxide, gas plasma and dry

heat should not be used, unless the Instructions for Use for the prod-

uct contains sterilization recommendations using these methods.

e)The above-mentioned principlesfor cleaningand sterilizationmust be

applied to all implants intended for implantation.

f) The surgical instruments used for implants insertion should also be

covered by cleaning and sterilization procedure.

10 RE-STERILIZATION

1. It is permitted to re-sterilize a device in case, when its sterile packaging

hasbeen damaged or opened. In this case,the product should be washed

and sterilizedin the mannerdescribed inthechapter RECOMMENDATIONS

FORIMPLANTS PROVIDED NON-STERILE.

1) ATTENTION: Implant that has been in contact with body tissues or uids

of a patient cannot be re-sterilized or implanted to another patient.

11 PRECAUTIONS

1. Implant is intended for single use only. After removing the implant from

the patient’sbody,it mustbesecured against re-use,andthen nally dis-

posed of in accordance with current hospital procedures.

2. Underno circumstances is it allowedtore-use or re-implant onceused de-

vice. Even if the removed implant appears to be undamaged, it may have

small latent defects or internal stresses, which could lead to early failure,

fatigue wear, and as a result to e.g. an implant breakage.

3. Misuse of instruments or implants may cause injury to the patient or op-

erative personnel.

4. Avoid damaging implant surface and deforming its shape during the im-

plantation; the damaged implant cannot be implanted or left in the pa-

tient’s body.

5. Insertion, removal and adjustment of implants must only be done with

instruments specially designated for those implants and manufactured

by ChM sp. z o.o.

6. Use of ChM’s implants and instruments in combination with implants

and instruments from other manufacturers may cause damage or failure

of those implantsor instrumentsandmay lead to improper course of sur-

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