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DHL

DHL
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DHL

Product catalog summary
Overview: This document provides comprehensive details on distal humeral locking plates used for fracture fixation in the upper arm, covering specifications, features, indications, contraindications, implantation procedures, postoperative care, and sterilization guidelines.
Specifications: The plates come in various configurations (medial and dorsolateral) and are designed for use with specific screws and tools, including cortical and cancellous screws, spiral drills, and screwdrivers.
Features: Made from titanium, the plates offer multidirectional locking and anatomical contouring, allowing for flexible screw angles. They are available in left and right versions, with screws made from TiAL6V4 ELI for enhanced fatigue strength and reduced inflammation risk.
Indications and Contraindications: Suitable for supra- and diacondylar upper-arm fractures. Not recommended for patients with severe osteoporosis, existing infections, or poor general health.
Implantation Procedure: Involves repositioning fractures and fixation with drill wires and screws, followed by definitive fixation using lateral ulnar and dorsal radial plates. The procedure should be performed shortly after trauma, with the patient in a prone position under anesthesia.
Postoperative Treatment: Stable repairs require dressing and movement therapy. For poor bone quality, a movement fixator or plaster cast is advised. Indometacin is recommended to prevent heterotopic ossification.
Sterilization Guidelines: Proper cleaning, disinfection, and sterilization of non-sterile implants and reusable instruments are crucial. Steam sterilization is recommended, with specific instructions for cleaning and maintenance.
Warnings and Precautions: Emphasizes careful handling of implants to prevent damage, avoiding mixing implants from different producers, and ensuring regular postoperative follow-ups.
Sterilization Recommendations: Follow manufacturer's guidelines for sterilization appliances, ensuring not to exceed maximum capacity when sterilizing multiple instruments.
Sterilization Cycle Parameters:
  • Prevacuum Cycle: 5 minutes at 134°C (273°F), 3.04 bar (27 psi), with a drying duration of 30 minutes.
  • Prevacuum² Cycle: 18 minutes at 134°C (273°F), 3 bar (28.5 psi), with a drying duration of 30 minutes, based on WHO's recommendations for instruments at risk of TSE/CJD contamination.
Disposal Guidelines: Adhere to hospital operator's guidelines for disposal.
Patient Information: Patients should be informed about the impact of implantation on discomfort, mobility, and life circumstances, and instructed on post-implantation behavior and reporting any negative changes.
Hospital Responsibility for Loaned Instruments:
  • Surgical instruments have a long service life but can degrade quickly due to misuse or insufficient protection.
  • Non-functional instruments due to wear, misuse, or improper care must be disposed of.
  • Returned medical products to I.T.S. GmbH must be cleaned, disinfected, inspected, and sterilized, with a decontamination confirmation.
Important Note:
  • Instructions are validated for preparing reusable medical products. Reconditioners must ensure the preparation process achieves desired results through validation and routine inspections.
  • Deviations from instructions should be evaluated for efficiency and potential negative consequences.
  • For questions or issues, contact I.T.S. GmbH.
Symbols and Standards: References standards and symbols such as RL 93/42/EWG, ÖNORM EN ISO 13485, and ISO 17664, indicating various sterilization methods and product information.
Contact Information: I.T.S. GmbH, part of the MED-HOLD GROUP, located at Autal 28, 8301 Lassnitzhöhe, Austria. Contact via phone: +43 316 211 21 0, fax: +43 316 211 21 20, or email: [email protected]. Website: www.its-implant.com.
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Catalog excerpts

DHL-1

r\ M I DISTAL HUMERAL LOCKING PLATES I I L emergency team for broken bones®

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DHL-2

Medial Plate Dorsolateral Plate DISTAL HUMERAL PLATES emergency team for broken bones® 37351-XX-N Cortical Screw, locking, D=3.5mm, SH 61273-100 Spiral Drill, D=2.7mm, L=100mm, AO Connector 56252 Screwdriver, WS 2.5, self-holding sleeve 32351-XX Cortical Screw, D=3.5mm 61273-100 Spiral Drill, D=2.7mm, L=100mm, AO Connector 56252 Screwdriver, WS 2.5, self-holding sleeve 37422-XX-N Cancellous Screw, locking, D=4.2mm, SH 61253-180 Spiral Drill, D=2.5mm, L=180mm, AO Connector 56252 Screwdriver, WS 2.5, self-holding sleeve 35164-150 Guide Wire, Steel, D=1.6mm, L=150mm, TR, with Thrd. 02 i.t.s.

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DHL-3

Features Features Implant: Material: • ultidirectional Locking M • ree choice of screw angle F • eft and right version L • natomically contoured A • 4.2 mm locking Cancellous Ø Screw • 3.5 mm Cortical Screw Ø • 3.5 mm locking Cortical Screw Ø • late material: Titanium P • aterial of screws: TiAL6V4 ELI M • asier removal of implant after fracture has E healed • mproved fatigue strength of implant I • educed risk of cold bonding R • educed risk of inflammation and allergy R locking DISTAL HUMERAL PLATES All I.T.S. locking plates are anatomically pre-contoured. In the unlikely event that the plate...

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DHL-4

Indications Contraindications • Supra- & diacondylar upper-arm fractures • evere osteoporosis S • Existing infections in the area of the fracture • trongly reduced general S condition. DISTAL HUMERAL PLATES emergency team for broken bones® Time of operation Approach Implantation • Within the first hours of the trauma or in the following days. • If the operation is not primary, arm should be immobilised in a splint. Median incision in the ulnar rim on the distal upper arm above the olecranon. Exposure and retraction of the ulnar nerve. Depending on the type of fracture, olecranonosteotomy and...

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DHL-5

Postoperative treatment • n case of stable repair of I fracture, dressing and movement therapy. • n case of poor bone quality or I insecure fixation, movement fixator for a maximum of 6 weeks or upper-arm plaster cast for a maximum of 3 weeks. • To prevent heterotopic ossification, Indometazin (Indozid) 50 mg 2 x daily for 2 weeks. locking DISTAL HUMERAL PLATES i.t.s. 05

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DHL-6

DISTAL HUMERAL PLATES emergency team for broken bones® Order No. New Humeral Plate, Distal, 4-Hole, Left, Dorsolateral 21242-4 New Humeral Plate, Distal, 4-Hole, Right, Dorsolateral 21241-4 1 Humeral Plate, Distal, 5-Hole, Left, Dorsolateral 21242-5 2 Humeral Plate, Distal, 5-Hole, Right, Dorsolateral 21241-5 New Humeral Plate, Distal, 6-Hole, Left, Dorsolateral 21242-6 New Humeral Plate, Distal, 6-Hole, Right, Dorsolateral 21241-6 New Humeral Plate, Distal, 7-Hole, Left, Dorsolateral 21242-7 New Humeral Plate, Distal, 7-Hole, Right, Dorsolateral 21241-7 3 Humeral Plate, Distal, 8-Hole, Left,...

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DHL-8

DISTAL HUMERAL PLATES emergency team for broken bones® Cortical Screw, D=3.5mm, L=24mm Cortical Screw, D=3.5mm, L=26mm 32351-26 Cortical Screw, D=3.5mm, L=28mm 32351-28 Cortical Screw, D=3.5mm, L=30mm 32351-30 Cortical Screw, D=3.5mm, L=32mm 32351-32 Cortical Screw, D=3.5mm, L=34mm 32351-34 Cortical Screw, D=3.5mm, L=36mm 32351-36 Cortical Screw, D=3.5mm, L=38mm 32351-38 Cortical Screw, D=3.5mm, L=40mm 7 32351-24 32351-40 37422-14-N Cancellous Screw, Locking, D=4.2mm, L=16mm, SH 37422-16-N Cancellous Screw, Locking, D=4.2mm, L=18mm, SH 37422-18-N Cancellous Screw, Locking, D=4.2mm, L=20mm, SH...

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DHL-10

DISTAL HUMERAL PLATES emergency team for broken bones® Cancellous Screw, Locking, D=4.2mm, L=48mm, SH 37422-48-N Cancellous Screw, Locking, D=4.2mm, L=50mm, SH 37422-50-N Cancellous Screw, Locking, D=4.2mm, L=55mm, SH 37422-55-N Cancellous Screw, Locking, D=4.2mm, L=60mm, SH 37422-60-N 8 56252 9 Depth Gauge , Solid Small Fragment Screws 59022 10 Cortical Counter Sink, with Stop Support 63404 11 Spiral Drill, D=2.5mm, L=180mm, AO-Connector 61253-180 12 Spiral Drill, D=2.7mm, L=100mm, AO-Connector 61273-100 13 Drill Guide, D=2.0/2.7mm 14 Guide Wire, Steel, D=1.6mm, L=150mm, TR, w. Gew 15 Sterilization...

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DHL-12

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: • • • • • ± 15° and Locking No pre threading No cold welding No debris Re-setting of screw (up to 3 times) 30° ® DOTIZE Chemical process - anodization in a strong alkaline solution * Type III anodization Dotize Type II anodization Layer thickness 60-200nm Layer thickness 2000-10 000nm + Different colors + Film become an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration...

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DHL-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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DHL-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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