video corpo

FCN

FCN
1 / 20 PagesView full catalog

FCN

Product catalog summary
Introduction
The document discusses the Flexible Children Nail (FCN) system, used in pediatric medullary fixation for shaft fractures. The nails are designed to be both elastic and stable, facilitating early weight-bearing and reducing hospital stays. They come in various lengths and diameters to accommodate different pediatric needs.
Properties
The FCN system provides elastic fracture fixation with minimal skin incision and closed procedure insertion. It preserves fracture hematoma for natural healing and offers optional distal locking for enhanced stability.
Indications & Contraindications
Indications include easily stabilizable fractures and certain pathological fractures. Contraindications include pathological fractures with unknown malignancy, infections, and non-compliance.
Biomechanics
The system converts thrust and shear forces into beneficial axial forces, promoting rapid fracture consolidation through callus formation. Locking options prevent implant migration.
Surgical Technique
The procedure involves pre-surgical positioning, nail insertion through a small incision, and fluoroscopy guidance. Postoperative care includes mobilization with crutches, with explantation after 6-9 months.
Information
The document includes an order list for various nail sizes and instruments, along with a reconditioning manual for cleaning, disinfection, and sterilization, emphasizing steam sterilization and avoiding abrasive materials.
Reconditioning Manual
Guidelines for reconditioning medical devices stress proper cleaning, disinfection, and handling to maintain implant and instrument integrity.
Cleaning and Disinfection Procedures
Instruments should be cleaned with a pH-neutral agent or a combined cleaning and disinfectant solution, such as Sekusept® Aktiv 2% by ECOLAB. Follow manufacturer guidelines on concentration, temperature, and exposure time. Use non-foaming agents for ultrasound cleaning and maintain a pH range of 4.5 - 10.5. Rinse thoroughly with tap water and dry immediately.
Manual Disinfection
If using a cleaning agent without disinfectant properties, a separate disinfection step is necessary. Use a VAH-listed disinfectant and ensure thorough drying.
Inspection and Maintenance
Inspect instruments for cleanliness and functionality. Lubricate movable parts with authorized products and check for ease of assembly. Follow standard packaging guidelines using sterile barrier systems.
Sterilization
Sterilize instruments using the fractionated pre-vacuum procedure according to EN 285 or EN 13060 and EN ISO 17665. Recommended steam sterilization parameters are 134°C for 5 to 18 minutes, especially if contamination with CJD pathogens is suspected.
Disposal and Responsibility
Hospitals must adhere to their disposal guidelines. Instruments returned to I.T.S. GmbH must be cleaned, disinfected, inspected, and sterilized, with a decontamination confirmation.
Important Information
Instructions are validated for reconditioning medical devices. Reconditioners must validate and routinely inspect their processes. Deviations from instructions should be evaluated for efficiency and potential negative impacts.
Patient Information
Patients should be informed about post-implantation care and the importance of reporting any negative changes or incidents affecting the implant.
Symbols and Contact Information
The document includes symbols for prescription, single use, sterilization methods, and other relevant information. Contact details for I.T.S. GmbH are provided for further inquiries.
See more

Catalog excerpts

FCN-1

Implants trauma Flexible Children Nail

 Open the catalog to page 1
FCN-3

1. Introduction P. 5 Preface P. 6 Screw P. 6 Properties P. 7 Indications & Contraindications P. 8 Biomechanics 2. Surgical Technique P. 9 Instruments P. 9 Presurgical P. 10 Surgical Technique P. 11 Postoperative treatment P. 11 Explantation P. 11 Summary 3. Information P. 13 Order list P. 16 Reconditioning Manual P. 18 Notes

 Open the catalog to page 3
FCN-5

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.

 Open the catalog to page 5
FCN-6

61273-100 Spiral Drill, D=2.7mm, L=l00mm, AO Connector conic, self-holding ♦ Elastic, yet stable fracture fixation ♦ Small skin incision ♦ Implant insertion at a side distant to the fracture (closed procedure) ♦ Fracture haematoma is left untouched (healing) ♦ Short hospital stay ♦ Distal lock for increased stability possible ♦ Version with loop and hook

 Open the catalog to page 6
FCN-7

Indications & Contraindications Indications: • Ideal in cases of easily stabilisable fractures such as transverse or short oblique fractures of the medial diaphyseal area. • Also suitable for borderline indications in difficultly stabilisable fractures, long oblique fractures, rotation or fragmented fractures, at least of the upper extremity. • Pathologically benign fractures (e.g. juvenile bone cysts) Contraindications: • Pathological fractures without identification of the malignant/benign character, particulary in cases of malignant tumours • Existing infections in the fracture zone and operation...

 Open the catalog to page 7
FCN-8

Biomechanics • The principle of the paediatric medullary nail is based on an “elastic, yet stable fixation”. • Due to the tolerance of the medullary nail to micro-movement, forces causing thrust and shear that may have negative impact on fracture healing will mainly be transformed into axial powers beneficial for fracture healing (pressure and traction). • Due to early movement (muscle tension) and weight-bearing, such positive powers will even be enhanced. As a consequence, rapid fracture consolidation based on extensive callus formation is observed. • Locking for increased stability is possible,...

 Open the catalog to page 8
FCN-9

Instruments • The instruments are used to introduce the nails of different lengths (13 - 14cm) and diameters (2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm) into the medullary cavity. • The instruments provide easy handling, comply with needs of shaft fracture treatment in children and thus allow for rapid and profound repair. Presurgical • The patient is positioned with the leg isolated and covered with drapes (or on an extension table) using at least one fluoroscopy in order to display both planes simultaneously. • Identification of the nail length is either performed using the fluoroscopy under consideration...

 Open the catalog to page 9
FCN-10

Surgical Technique • After skin incision, soft tissue is bluntly separated and then the drilling hole is established with the nail being carefully introduced into the created opening. • Using the awl, the drilling hole is established above the epiphysis maintaining a distance that allows for additional locking above the epiphyseal plate. • Perform the same procedure on the other side. • Then, both nails are being successively introduced beyond the fracture gap under fluoroscopy guidance. • In femoral fractures: • The medial nail is anchored in the femoral neck, the lateral nail under the greater...

 Open the catalog to page 10
FCN-11

Postoperative treatment • Mobilization with forearm crutches, while increasing weight-bearing (depending on pain). Explantation After 6-9 months (depending on age and fracture), the material is removed using appropriate removal instruments. Retraction hook 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 stabilized without impairment of the periosteum or the fracture haematoma. The 3-point support offers sufficient stability. The optional distal lock prevents...

 Open the catalog to page 11
FCN-13

Order list Children‘s Nail, D=2.0mm, L=130mm, with hook Children‘s Nail, D=2.0mm, L=140mm, with hook Children‘s Nail, D=2.0mm, L=150mm, with hook Children‘s Nail, D=2.0mm, L=160mm, with hook Children‘s Nail, D=2.0mm, L=170mm, with hook Children‘s Nail, D=2.0mm, L=180mm, with hook Children‘s Nail, D=2.0mm, L=190mm, with hook Children‘s Nail, D=2.0mm, L=200mm, with hook Children‘s Nail, D=2.0mm, L=210mm, with hook Children‘s Nail, D=2.5mm, L=150mm, with hook Children‘s Nail, D=2.5mm, L=160mm, with hook Children‘s Nail, D=2.5mm, L=170mm, with hook Children‘s Nail, D=2.5mm, L=180mm, with hook Children‘s...

 Open the catalog to page 13
FCN-14

Spiral Drill, D=2.7mm, L=100mm, AO Connector Sterilization Tray, Children‘s Nail, Implants Sterilization Tray, Children‘s Nail, Instruments

 Open the catalog to page 14
FCN-16

Reconditioning Manual The information below should help you in reconditioning medical devices. IMPORTANT INDICATIONS FOR DOCTORS & OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied non-sterile 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 packaging label. Make sure that you are familiar with the possible application, combinability and correct handling of the product. Please note that product systems...

 Open the catalog to page 16
FCN-17

Manual disinfection If a cleaning agent without a disinfectant effect is used, separate disinfection must be carried out after manual cleaning. (Order: Decontamination for staff protection, cleaning, disinfection). Equipment: Commercially available disinfectant authorised for use with medical products from the VAH list. Manufacturer‘s information, e.g. concerning concentration, temperature and exposure time should be followed. The steps described in the table above also apply. Patient Information Implantation has consequences for the discomfort, mobility and general life circumstances of the...

 Open the catalog to page 17

All I.T.S. catalogs and technical brochures

  1. ufs

    1  Page

  2. DHL

    2  Pages

  3. ITS

    2  Pages

  4. SCL

    32  Pages

  5. SLS

    24  Pages

  6. PHL

    24  Pages

  7. PHLs

    20  Pages

  8. CLS

    28  Pages

  9. ACLS

    20  Pages

  10. CFN

    32  Pages

  11. OLS

    24  Pages

  12. SR Sacral Rods

    20  Pages

  13. HCS

    24  Pages

  14. TLS

    20  Pages

  15. PRS-RX

    32  Pages

  16. HLS

    20  Pages

  17. ES

    20  Pages

  18. SR

    20  Pages

  19. FL

    24  Pages

  20. FLS

    24  Pages

  21. PFL

    20  Pages

  22. DTL

    24  Pages

  23. HTO

    24  Pages

  24. PTL

    32  Pages

  25. DFL

    32  Pages

  26. CAS

    40  Pages

  27. HOL

    24  Pages

  28. CAL

    20  Pages

  29. DUL

    24  Pages

Archived catalogs

  1. CS

    16  Pages

  2. OL

    16  Pages

  3. OHL

    24  Pages

  4. SL

    16  Pages

  5. SR Old

    20  Pages

  6. ES Old

    20  Pages

  7. CAS Old

    36  Pages

  8. SN Old

    16  Pages

  9. FCN Old

    16  Pages

  10. FTN

    12  Pages

  11. CLS

    24  Pages

  12. DFL Old

    28  Pages

  13. PRS

    28  Pages

  14. PHL

    16  Pages

  15. DHL

    16  Pages

  16. PRL

    28  Pages

  17. UOL

    32  Pages

*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.