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FCN Old

FCN Old
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FCN Old

Product catalog summary
Overview: The document details the Flexible Children Nail, a medical device for treating shaft fractures in children. It covers features, indications, contraindications, surgical techniques, and guidelines for use and sterilization.
Specifications: Made of implant steel, the nail comes in various lengths and diameters, offering an elastic yet stable design for fracture fixation. It supports early weight-bearing and short hospital stays.
Indications and Contraindications: Suitable for stabilizing transverse or short oblique fractures and some complex fractures. Contraindicated for pathological fractures with unidentified malignancy and infections.
Biomechanics: The design allows micro-movement, converting negative forces into beneficial axial forces for healing. Locking mechanisms enhance stability and prevent migration.
Surgical Technique: Involves a small incision, nail insertion under image guidance, and optional distal locking. Postoperative care includes mobilization with crutches and gradual weight-bearing.
Instruments and Implants: Includes a range of nails, cortical screws, and instruments for insertion and removal, with specific order numbers listed.
Sterilization and Maintenance: Guidelines for cleaning, disinfection, and steam sterilization are provided, with precautions to ensure safety and efficacy.
Warnings and Precautions: Emphasizes following instructions, avoiding implant alterations, and regular follow-ups. Advises against combining implants from different manufacturers.
Conclusion: The Flexible Children Nail is effective for pediatric fracture repair, offering stability, rapid healing, and early mobilization.
Drying and Sterilization Procedures: Two pre-vacuum sterilization procedures are outlined, aligning with WHO recommendations for TSE/CJD contamination risk.
Disposal Guidelines: Disposal should follow hospital operator guidelines.
Patient Information: Patients should be informed about potential discomfort and mobility changes, and report any negative changes or accidents.
Hospital Responsibility for Loaned Instruments: Instruments must be cleaned, disinfected, inspected, and sterilized before returning to I.T.S. GmbH, with decontamination confirmation.
Important Note: Instructions are validated for reconditioning suitability. Reconditioners must ensure effective reconditioning through validation and routine inspections.
Symbols and Standards: References standards such as RL 93/42/EWG, ÖNORM EN ISO 13485, and ISO 17664, with symbols for single use, expiry date, and sterilization methods.
Contact Information: I.T.S. GmbH, part of the MED-HOLD GROUP in Austria, provides contact details for inquiries.
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Catalog excerpts

FCN Old-1

FLEXIBLE CHILDREN NAIL emergency team for broken bones®

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FCN Old-2

Preface Over the last years, the elastic, yet stable medullary fixation of shaft fractures in children has become standard when treating diaphyseal fractures. Paediatric nails have been modified to match conditions in children and are now available in different lengths and diameters. Features Implant: • lastic, yet stable fracture fixation E • mall skin incision S - Implant insertion at a site distant to the fracture (closed procedure) - Fracture haematoma is left untouched (healing) • imple technique S • arly weight-bearing E • hort hospital stay S • hild-friendly C • istal lock for increased...

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FCN Old-3

FLEXIBLE CHILDREN NAIL ■■ [■■■■[■■■■[■■■■[■■■■IIIIIIIIIIIII ■■ !■ ■■■[■■■■[■■■■[■■■■[■■■■IIIIIIIIII !■ ■■■■IIIIIIIIIIIIIIIIIIIIIIIIIIII ■■ ■[■■■■[■■■■[■■■■[■■■■IIIIIIIIIIII ■■ ■! ■■■■[■■■■[■■■■[■■■■IIIIIIIIIIIIII ■! ■■■■[■■■■[■■■■[■■■■[■■■■IIIIIIIIIIIIII ■! ■■■■ IIIIIIIIIIIIIIIIIIIIIIIIIIIII ■■ [■■■■[■■■■IIIIIIIIIIIIIIIIIIIIIII ■■ !■ ■■■[■■■■[■■■■[■■■■[■■■■[■■■■[■■■■I

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FCN Old-4

• deal in cases of easily stabilisable I fractures such as transverse or short oblique fractures of the medial diaphyseal area. • lso suitable for borderline A indications in difficultly stabilisable fractures, long oblique fractures, rotation or fragmented fractures, at least of the upper extremity. • athologically benign fractures P (e.g. juvenile bone cysts) • athological fractures without P identification of the malignant/ benign character, particularly in cases of malignant tumours • nfections I FLEXIBLE CHILDREN NAIL emergency team for broken bones® Biomechanics The principle of the paediatric...

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FCN Old-5

Instruments The instruments are used to introduce the nails of different lengths (13 - 40 cm) and diameters (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm) into the medullary cavity. FLEXIBLE CHILDREN NAIL The instruments provide easy handling, comply with needs of shaft fracture treatment in children, and thus allow for rapid and profound repair.

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FCN Old-6

Presurgical The patient is positioned with the leg isolated and covered with drapes (or on an extension table) using at least one X-ray image converter in order to display both planes simultaneously. Identification of the nail length is either performed using the X-ray image under consideration of magnification or intraoperatively directly aligned with the extremity. The nail will be pre-curved with the maximum curvature at the fracture level. FLEXIBLE CHILDREN NAIL emergency team for broken bones® Surgical Technique After skin incision, soft tissue is bluntly separated and then the drilling...

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FCN Old-7

Postoperative Mobilisation with forearm crutches, while increasing weight-bearing (depending on pain). FLEXIBLE CHILDREN NAIL Removal After 6-9 months (depending on age and fracture), the material is removed using appropriate removal instruments. Retraction hook

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FCN Old-8

FLEXIBLE CHILDREN NAIL emergency team for broken bones® Summary The elastic stable feather nail is the ideal paediatric medullary nail when repairing shaft fractures in growing bones. Due to implant insertion at a distant site, the fracture can be stabilised without impairment of the periosteum or of the fracture haematoma. The 3-point support offers sufficient stability. The optional distal lock prevents any migration of the nails, particularly in fractures of the lower extremity. Moreover, locking provides increased stability. The implant offers ideal properties to perform child-oriented fracture...

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FCN Old-9

Case studies Thigh *Reference: Tscherne Unfallchirurgie/Unfallchirurgie im Kindesalter. © Springer Verlag. FLEXIBLE CHILDREN NAIL

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FCN Old-10

Implants & Instruments FLEXIBLE CHILDREN NAIL emergency team for broken bones® Children‘s Nail, D=3.0mm, L=210mm, with loop Children‘s Nail, D=3.0mm, L=220mm, with loop Children‘s Nail, D=3.0mm, L=230mm, with loop Children‘s Nail, D=3.0mm, L=240mm, with loop Children‘s Nail, D=3.0mm, L=250mm, with loop Children‘s Nail, D=3.0mm, L=260mm, with loop Children‘s Nail, D=3.0mm, L=270mm, with loop Children‘s Nail, D=3.0mm, L=280mm, with loop Children‘s Nail, D=3.5mm, L=270mm, with loop Children‘s Nail, D=3.5mm, L=280mm, with loop Children‘s Nail, D=3.5mm, L=290mm, with loop Children‘s Nail, D=3.5mm,...

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FCN Old-11

FLEXIBLE CHILDREN NAIL

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FCN Old-12

Implants & Instruments FLEXIBLE CHILDREN NAIL emergency team for broken bones® Cortical Screw, D=3.4mm, L=50mm Cortical Screw, D=3.4mm, L=52mm Impactor, Children‘s Nail Extraction Instrument Impaction, Extraction Instrument Sterilization Tray, Children‘s Nail, Implants Sterilization Tray, Children‘s Nail, Instruments Intubation Instrument

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FCN Old-13

FLEXIBLE CHILDREN NAIL

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FCN Old-14

Sterilization Guidelines The following remarks should serve as a guideline in the sterilization of medical products. IMPORTANT INDICATIONS FOR DOCTORS AND OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied nonsterile implants and all reusable instruments from I.T.S. GmbH. Detailed information for the identification of the product (such as system classification, cat. no.) can be found in the product identification code and/ or on the package label. Make sure that you are familiar with the possibilities of application, combinability and correct handling of the product....

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FCN Old-15

Sterilization Guidelines Disinfection Equipment: Commercially available disinfectants authorized for use with medical products e.g.. MEDICLEAN FORTE) can be used (but only according to the instructions of the disinfectant producer). In the case of automatic cleaning, a final rinse cycle at 90 °C for 5 minutes can be finally carried out to provide thermal disinfection. Drying Drying as part of the cleaning/ disinfection cycle should not exceed 110 °C. Checking, Maintenance and Inspection • Each instrument or implant is to be inspected carefully to make sure that all visible dirt has been removed....

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FCN Old-16

I.T.S. GmbH part of the MED-HOLD GROUP Autal 28, 8301 Lassnitzhöhe Austria Tel.: +43 | 316 | 211 21 0 Fax: +43 | 316 | 211 21 20 [email protected] www.its-implant.com Order No. FCN-OP-0111-E Edition: January/2011 © I.T.S. GmbH Graz/Austria 2011. Subject to technical alterations, errors and misprints excepted.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.