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OLS

OLS
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OLS

Product catalog summary
Introduction
The Olecranon Locking Plates System is designed for early functional postoperative treatment of olecranon fractures, providing an alternative to conventional tension band methods that may limit mobility. The system includes anatomically preformed plates that can be adjusted by careful bending.

Specifications
The system uses titanium plates and TiAl6V4 ELI screws. Key features include multi-directional locking, anatomical contouring, and a sliding hole for optimal positioning.

Indications & Contraindications
Indicated for dislocated olecranon fractures, the system is contraindicated for patients with blood clotting issues, critical general conditions, diabetes, soft tissue damage, obesity, pre-existing elbow arthrosis, or lack of compliance.

Surgical Technique
Pre-operative preparation involves anesthesia and positioning the patient supine or abdominally. Access is through a bow-shaped incision, and implantation involves careful exposure of fracture segments, using olecranon hook plates for single fragment fractures and K-wires for multi-fragment fractures.

Postoperative Treatment
Postoperative care includes an upper arm cast, physical therapy, and early functional therapy after suture removal. Implants can be removed after 1.5 years or upon radiographic confirmation of healing.

Information
Dotize® Anodization enhances implant surfaces, reducing inflammation risk and increasing fatigue resistance. The locking mechanism uses screw material harder than the plate material for secure fixation without pre-threading.

Reconditioning Manual
Guidelines emphasize cleaning, disinfection, and sterilization of non-sterile implants and reusable instruments, avoiding surface damage, and ensuring compatibility with other implants.

Warnings and Precautions
Implants are single-use only and should not be altered. Regular postoperative follow-ups are necessary, and combining implants from different manufacturers is not recommended.

Specifications and Recommendations
The document outlines cleaning and disinfection procedures using Neodisher® Mediclean forte with a pH of 9-11. Recommended equipment for automatic cleaning is the Miele PG 8536 machine, validated according to EN ISO 15883 and ÖGSV guidelines.

Automatic Cleaning and Disinfection Procedure
The process includes pre-rinsing with softened water, cleaning with purified water at 55°C, rinsing, thermal disinfection at 90°C, and drying at 110°C. Jointed instruments should be opened, and cannulated instruments connected to rinsing nozzles. Instruments should be checked for visible dirt after disinfection.

Manual Cleaning/Disinfection
Manual cleaning is discouraged due to low efficacy but can support automatic processes for heavily soiled instruments. Recommended agents include Sekusept® Aktiv 2% by ECOLAB. Instruments should be soaked, cleaned, and rinsed thoroughly, with special attention to hard-to-reach areas.

Inspection and Maintenance
Instruments must be inspected for dirt and functionality. Movable parts should be lubricated, and reassembly should be checked for ease. Packaging should follow standard guidelines using sterile barrier systems.

Sterilization
Sterilization should be performed using the fractionated pre-vacuum procedure at 134°C for 5 minutes, following EN 285 and EN ISO 17665 standards. Special parameters apply if contamination with CJD pathogens is suspected.

Disposal and Responsibility
Hospitals must follow their guidelines for disposal. Instruments returned to I.T.S. GmbH must be cleaned, disinfected, and sterilized, accompanied by a decontamination confirmation.

Important Information
The instructions are validated for reconditioning medical devices. Reconditioners must ensure the process achieves desired results through validation and routine inspections. Deviations should be evaluated for efficiency and consequences.

Patient Information
Patients should be informed about post-implantation behavior and the importance of reporting any negative changes or accidents.

Symbols and Standards
The document includes symbols for prescription, single use, sterilization methods, and compliance with standards like RL 93/42/EWG, ÖNORM EN ISO 13485, and ISO 17664.
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Catalog excerpts

OLS-1

Implants trauma Olecranon Locking Plates System

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OLS-2

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, plate might break. All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent...

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OLS-3

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Pre-operative patient preparation P. 10 Access P. 11 implantation P. 11 implantation of single fragment fractures P. 13 implantation of multi fragment fractures P. 15 Case studies P. 16 Postoperative treatment P. 16 Explantation 3. Information P. 17 Notes P. 19 Locking P. 19 Dotize® P. 20 Order list P. 22 Reconditioning Manual

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OLS-5

Preface The primary advantage of the locking olecranon plates lie in early functional postoperative treatment. Conventional fracture treatment with tension bands and subsequent immobilization can lead to heterotopic ossifications and subsequent limited mobility in the elbow.

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OLS-6

o Screws Cortical Screw, locking, D=3.5mm, SH Spiral Drill, D=2.7mm, L=l00mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Cortical Screw, D=3.5mm Spiral Drill, D=2.7mm, L=l00mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve J Cancellous Screw, locking, D-4.2mm, SH Spiral Drill, D=2.5mm, L=ll0mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve

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OLS-7

Properties Properties of the implant: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Multi-directional locking • Anatomically contoured • Optimal reconstruction of the joint surface • Simple positioning due to sliding hole Olecranon Hook Plate: Olecranon Plate: • Sliding hole with compression option up to 4mm • Lengths: 5-hole left/right 7, 9-hole left 7, 9-hole right • Lengths: 6, 8, 10, 12-hole • Long...

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OLS-8

♦ ALL disLoeated fractures of the oLeeranon Contraindications: ♦ GeneraL probLems with bLood cLotting ♦ Critical generaL condition ♦ Diabetes ♦ Damage of soft tissue ♦ Obesity ♦ Pre-existing arthrosis of the elbow ♦ Lack of patient compliance Time of operation: ♦ Primary on the first day after the trauma ♦ Secondary after swelling subsides, temporary fixation in an upper arm plastercast or with an external fixing device

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OLS-9

Surgical Technique

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OLS-10

Pre-operative patient preparation • Under a general anaesthesia or plexus anaesthesia with pneumatic partial deprivation of blood supply • Supine position or abdominal position Access A slightly bow-shaped skin incision should be made in the radial direction, deviating from the ulnar edge, in order to create a soft tissue flap which will cover the plate. The scar should not extend directly above the plate. However, in individual cases, preexisting scars or deep abrasions can cause access to be changed.

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OLS-11

Implantation The bone is skillfully prepared with the scalpel. The fracture segments should be exposed as carefully as possible in order to not further decrease blood flow. The elbow joint should be radially exposed as far as necessary to enable a good view of the joint surface of the olecranon, and of the final reduction. Implantation of single fragment fractures Single fragment fractures can be reduced directly with the olecranon hook plate. It is implanted like a reduction hook and is initially screwed to the ulna in the sliding hole. When compression principle of the sliding hole is fully...

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OLS-12

The necessary remaining screws can then be inserted at a fixed angle, where required, in order to securely capture all parts of the fracture. The objective of operative treatment is to achieve stable fixation of the fragments. Olecranon Hook Plate Olecranon Plate

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OLS-13

Implantation of multi fragment fractures In the case of multi fragment fractures, K-wires can be used to temporarily fix intermediate fragments. Depending on the fracture, the sliding hole can initially be loosely engaged. The olecranon fragments can be inserted at a fixed angle before the main fracture is definitively fixed by tightening the screw in the sliding hole.

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OLS-14

The necessary remaining screws can then be inserted at a fixed angle, where required, in order to securely capture all parts of the fracture. The objective of operative treatment is to achieve stable fixation of the fragments.

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OLS-15

Case studies Case 1 - Olecranon Hook Plate: • Pre- and intraoperative radiographs following fixed angle fixation of a multi fragment fracture of the olecranon AO 21 B1. Case 1 - Olecranon Plate: • Pre- and intraoperative radiographs following fixed angle fixation of a fracture of the olecranon AO 21 A1.

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OLS-19

o Locking Locking works because of: ♦ Screw material (TiALV) is slightly harder than plate material (Titanium Grade 2) ♦ Screw head forms thread into the plate (no cutting) Benefits: ♦ ± I50 and Locking ♦ No pre threading ♦ No cold welding ♦ No debris ♦ You can re-set the screw up to 3 times Dotize Type II anodization ♦ Layer thickness 60-200nm Different colors + Film becomes an interstitial part of the titanium Implant surface remains sensitive to: Chipping - No visible cosmetic effect Peeling Discoloration Anodization Type II leads to following benefits* ♦ Oxygen and silicon absorbing...

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OLS-20

Olecranon Hook Plate, 5-hole, Right/Left Olecranon Hook Plate, 7-hole, Left Olecranon Hook Plate, 9-hole, Left Olecranon Hook Plate, 7-hole, Right Olecranon Hook Plate, 9-hole, Right Olecranon Plate, 6-hole Olecranon Plate, 8-hole Olecranon Plate, 10-hole Olecranon Plate, 12-hole Cortical Screw, locking, D=3.5mm, L=i2mm, SH Cortical Screw, locking, D=3.5mm, L=i4mm, SH Cortical Screw, locking, D=3.5mm, L=i6mm, SH Cortical Screw, locking, D=3.5mm, L=i8mm, SH Cortical Screw, locking, D=3.5mm, L=20mm, SH Cortical Screw, locking, D=3.5mm, L=22mm, SH Cortical Screw, locking, D=3.5mm, L=24mm, SH Cortical...

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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.