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Cannulated (subtalar) screw

Cannulated (subtalar) screw
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Cannulated (subtalar) screw

Product catalog summary
Introduction
The document discusses the use of a cannulated subtalar screw for treating pes plano-valgus (flat feet) in children and adolescents. It specifies indications for use, including fixed and flexible pes plano-valgus and cases with Achilles tendon contracture. The implants meet ISO 5832 standards and Directive 93/42/EEC for medical devices, ensuring high quality.

Implants
The cannulated subtalar screw is available in various sizes, with specific catalogue numbers. Made from titanium or titanium alloy, these screws are durable and compatible with the human body.

Instrument Set
The instrument set (40.6590.000) includes tools for insertion and removal of the subtalar screw, designed for easy storage and transportation. Key components include guide rods, trials, a screwdriver, and a Steinmann handle.

Surgical Technique
Surgical Approach: A 1-3 cm incision is made on the lateral aspect of the foot over the sinus tarsi region.
Implant Insertion: The guide rod is inserted into the sinus tarsi using the Steinmann handle. Trials determine the correct implant size, which is then inserted via the guide rod.
Implant Removal: The guide rod positions the screwdriver in the screw socket for removal by turning counterclockwise.

Instructions for Use
The instruments are intended for use by trained medical professionals. Detailed instructions on packaging, materials, and handling emphasize proper cleaning, disinfection, and sterilization. Materials include corrosion-resistant steel, aluminum alloys, and plastics.

Warnings and Precautions
Improper handling can lead to damage and reduced lifespan. Instruments should be inspected before use, and damaged items replaced. The document advises on potential allergic reactions and the importance of following calibration deadlines for torque instruments.

Cleaning, Disinfection, Sterilization
Non-sterile devices must be thoroughly cleaned, disinfected, and sterilized before use. The document outlines effective cleaning steps and hospital responsibilities.

Cleaning and Disinfection Methods
Two approved methods: manual with ultrasound cleaning and automated cleaning using a washer-disinfector. Automated cleaning is recommended. Cleaning agents must be suitable for medical devices, with a pH between 10.4 and 10.8.

Manual Cleaning Procedure
Initial manual cleaning is required before ultrasound cleaning. Use a detergent solution at 40±2°C, pH 10.4-10.8. Rinse thoroughly and inspect for debris. Ultrasound cleaning follows, with a 15-minute immersion. Final rinsing should use demineralized water.

Automated Cleaning Procedure
Preceded by manual and ultrasound cleaning. Follow ISO 15883 standards. The cycle includes pre-washing, washing, rinsing, thermal disinfection, and drying.

Inspection
Inspect devices for dirt and corrosion before reuse. Check functionality and structural integrity. Damaged products should not be reused.

Packaging and Sterilization
Devices should be stored in sterilization containers meeting ISO 11607 standards. Recommended sterilization is vacuum-type steam at 134°C for 7 minutes.

Storage and Calibration
Store instruments in a clean, dry environment. Regular calibration is required for torque instruments.

Compatibility
ChM instruments are designed for ChM implants only. Combining with other manufacturers' products is not allowed.

For further information, contact ChM sp. z o.o. or visit www.chm.eu.
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Catalog excerpts

Cannulated (subtalar) screw-1

Cannulated (subtalar) screw • IMPLANTS • INSTRUMENT SET 40.6590.000 • SURGICAL TECHNIQUE

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Cannulated (subtalar) screw-2

SYMBOLS DESCRIPTIONS The manufacturer reserves the right to introduce design changes.

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II.1. CANNULATED (SUBTALAR) SCREW 6

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Cannulated (subtalar) screw-5

I. INTRODUCTION The cannulated (subtalar) screw is a one-element device that is used in the treatment of pes plano-valgus (flat feet) in children and adolescents. Indications for use: • fixed pes plano-valgus, • flexible pes plano-valgus, • pes plano-valgus with Achilles tendon contracture. The presented range of implants is made of materials in accordance with ISO 5832 standard. Compliance with the requirements of quality management systems and the requirements of Directive 93/42/EEC concerning medical devices guarantee high quality of the offered implants.

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II. IMPLANTS II.1. CANNULATED (SUBTALAR) SCREW ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec Kościelny, POLSKA, tel. + 48 85 86 86 100, fax + 48 85 86 86 101, [email protected], www.chm.eu

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III. INSTRUMENT SET Instrument set [40.6590.000] is used to insert the subtalar screw, and to remove the implant after the treatment period. All instruments are placed on a stand with a container and lid to facilitate storage and transportation to the operating suite. Instrument set for cannulated (subtalar) screws 40.6590.000 Steinmann handle Perforated aluminum lid 1/1 595x275x15mm Gray Container with solid bottom 1/1 595x275x86mm 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

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SURGICAL TECHNIQUE IV.1. SURGICAL APPROACH  1  Perform an incision for 1-3 cm on the lateral aspect of the foot over the sinus tarsi region. IV.2. IMPLANT INSERTION  2  Using STEINMANN handle [40.0987.200], insert guide rod 2.0/380 [40.6597.380] into the sinus tarsi. The end of the rod should be perceptible on the other side of the food inferior to the medial maleollus - a small bulge of the skin should be visible.  3  Insert in turn trials until the correct position of the calcaneus is achieved inclined by 2° ÷4° from the neutral position. The size of the last trial indicates the size of the...

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SURGICAL TECHNIQUE  4  Mount chosen implant to the screwdriver S4 [40.6591] tip and via guide rod [40.6597.380] insert it into sinus tarsi. Remove screwdriver and guide rod. IV.3. IMPLANT REMOVAL  5  Insert guide rod [40.6597.380] into the sinus tarsi. Using the guide rod, insert screwdriver S4 [40.6591] tip in the socket of the subtalar screw. Remove the implant turning the screwdriver counterclockwise. The above description is not detailed instruction of conduct. The surgeon decides about choosing the operating procedure.

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REUSABLE ORTHOPAEDIC AND SURGICAL INSTRUMENTS processing area in a closed container or covered with a damp cloth. 3) In order to avoid contamination during transportation, the dirty instruments should be separated from the clean ones. 3.Preparation for washing and disinfection (for all methods). 1) The used instruments should be reprocessed as soon as possible. 2) If the instrument can be disassembled, it must be done before cleaning processes. 3) Rinse under running water and remove surface debris using a disposable cloth, paper towel or plastic brushes (nylon brushes are recommended). Particular...

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