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This document provides information on medical implant instrumentation and sets for osteosynthesis procedures. It describes steel implant materials, indications and contraindications for use, cleaning and sterilization requirements. Instrument sets are listed, including drills, taps, guides, templates and other tools for placing bone screws and plates. Proper use and potential risks are outlined.

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MEDICAL ADVANCED TECHNOLOGY STEEL DHSP / DCSP DYNAMIC HIP - AND CONDYLAR SCREW PLATE SYSTEM IncludeS basic large fragment instruments
2 Contact Friedrich-Wöhler-Straße 10 78576 Emmingen, Germany phone +49(0)74 65 / 909188 Fax +49(0)74 65 / 909024 Internet info@mat-medical.com Manual for use under our Hompage: www.mat-medical.com INSTRUCTIONS FOR USE 3. (GB) Warning: The implants described may only be used in combination with MAT products! OSTEOSYNTHESIS – STEEL IMPLANTS (Bone: Plates / Screws / Pins / Wires / Clips) non-sterile IMPLANT MATERIAL: Implants made from steel in accordance with ISO 5832 – 1 stainless steel ; ISO 5832 – 9 high nitrogen stainless steel manufactured by MAT MEDICAL AD- VANCED TECHNOLOGY. The surface of these implants is chemically passive: not magnetic. These implants can be combined with the standardised material provided that its composition lies within the analysis stipulated in the ISO 5832 – 1 / ISO 5832 – 9 standard and the required specifications. Material alloys with chrome-nickel (implant steel) components can trigger a so-called chrome-nickel allergy by their nature; there are no other known biocompatible hazards! We would point out that implants only function correctly if the following basic rules are observed: - When selecting implants (bone: plates / screws / pins wires / clips), care must be taken to choose the appropriate implants on the basis of the weight and level of activity of the patient, and the bone fracture to be treated. - Note that by making the correct choice of biomechanics the forces to be transferred by the implants remain low. - Extreme deformation of the implants must be avoided; the cautious bending of wires, plates and pins does not, however, lead to implant damage provided it is done with sufficient care. - Repeated deformation should be avoided at all costs as it will fatigue the implant material. - The re-use of implants is absolutely forbidden (single use). - We strongly advise you to inform patients of the advantages and disadvantages of implants. - Excessive strain as a result of body weight and the level of activity of the patient should be avoided due to the limited strength of the im plants. Failure to observe these precautionary measures can have serious consequences for the healing process. INDICATIONS These relate to the current practice of applications of implants in osteosynthesis (e.g. see literature AO/ASIF Instruments and Implants Texhammer*Colton ISBN 3-540-56895-6 / ISBN 0-387-56895-6). CONTRAINDICATIONS Acute and chronic infections; muscle, nerve or vascular diseases that endanger the affected extremity; a lack of bony tissue or poor bone quality (e.g. severe osteoporosis); local bone tumours. Systemic diseases and metabolic disorders; infections and falls; drug dependence; obesity; highly physical activities together with activities involving extreme vibrations which can lead to overstraining of the implants. NOTES The user should record and keep all information provided to the patient. It should be checked before use whether the patient tolerates the material to be implan- ted. The implants described in these instructions for use may only be used (implanted) by surgeons with the appropriate experience. POSSIBLE NEGATIVE EFFECTS (RISKS) Failure of the fracture to heal, allergy to the material, failure of the product (break, bending), bone deformation and refracture, infection. REMOVAL OF IMPLANTS The implants are normally removed once the fracture has healed. CLEANING AND STERILISATION OF UNSTERILE IMPLANTS Before use, the implants must be sterilised using a validated procedure (autoclaved). MAT MEDICAL ADVANCED TECHNOLOGY VALIDATED PROCEDURES STERILISER: Steam autoclave: Temperature = 121° to 123° Celsius; Pressure = 1-1.2 bar (15 to 17 psi) with an exposure time of at least 30 minutes in the packaged state. STERILISER: Autoclave with prevacuum: During the prevacuum phase the air is extracted from the chamber before the steam flows in. Standard circulation for packaged objects: 132° to 135° Celsius; Pressure = 2 – 3 bar (27 to 30 psi) with an exposure time of at least 4 to 10 minutes. IMPORTANT NOTES: Every time the implants are used or sterilised you must first check that they function perfectly! In the event of failure to observe these instructions or demonstrable violation, no guarantee or compensation for damages can be provided. LARGE fragment Manual for use 3.
3 SET - LISTING FOR SET: SET-011-0010-010 dhsp / dcsp instrument set complete ref. - NO.: index - instruments: TRAY-011-0010-010 Graphic case (tray in steel) tray for DHSP / DCSP instrument - 1-Pcs. 006-0010-002 Calibrated threaded Guide Pin ø 2.5 mm x length 230 mm -10-Pcs. 006-0010-004 Drill guide adjustable 125° up to 150° - 1-Pcs. 006-0010-006 Direct measuring device - 1-Pcs. 006-0010-007 Angled drill guide for condylar plates 95° - 1-Pcs. 006-0010-008 Triple reamer complete for dynamic hip screw plates - 1-Pcs. 006-0010-009 Triple reamer compolete for dynamic dondylar screw plates - 1-Pcs. 006-0010-010 Tap for lag screws - 1-Pcs. 006-0010-012 Centring sleeve short for used tap - 1-Pcs. 006-0010-014 Centring sleeve long for used wrench - 1-Pcs. 006-0010-016 Guide shaft for coupling screw short - 1-Pcs. 006-0010-018 Coupling screw for wrench - 1-Pcs. 006-0010-020 Coupling screw short for guide shaft - 2-Pcs. 006-0010-022 Wrench for used assembled guide shaft short with coupling screw - 1-Pcs. 006-0010-024 Impactor - 1-Pcs. 006-0010-026 T-handle with quick coupling - 1-Pcs. set-011-0010-010 dhsp / dcsp instrument set
4 set-011-0010-010 Dhsp / dcsp instrument set TRAY-011-0010-010 Graphic case ( tray in steel ) tray for DHSP / DCSP instrument
5 sterilization container for set-011-0010-010 Recommended sterilization container for Set-011-0010-010 ref. - NO.: sterilization container: cb-105-135 Container bottom non perforated 580 x 280 x 135 mm cl-100-010 Container lid perforated 580 x 280 mm
6 DHSP / DCSP - Instruments 006-0010-004 Drill guide adjustable 125° up to 150° 006-0010-005 Drill guide adjustable 125° up to 150° used for three guide pins ( without picture ) 006-0010-002 Calibrated threaded Guide Pin ø 2.5 mm x length 230 mm 006-0010-007 Angled drill guide for condylar plates 95°
7 Instruments 006-0010-006 Direct measuring device 006-0010-008 Triple reamer complete for dynamic hip screw plates - DHSP 006-0010-009 Triple reamer complete for dynamic hip condylar screw plates - DCSP 006-0010-010 Tap for lag screws
8 006-0010-012 Centering sleeve short for used tap 006-0010-014 Centering sleeve long for used wrench 006-0010-016 Guide shaft used for coupling screw short REF.: 006-0010-020 006-0010-018 Coupling screw used for wrench REF.: 006-0010-022 dhsp / DCSP - Instruments
9 dhsp / DCSP - Instruments 006-0010-020 Coupling screw short for guide shaft 006-0010-022 Wrench for used assembled guide shaft short with coupling screw 006-0010-024 Impactor 006-0010-026 T-handle with quick coupling
10 set-011-0010-004 large fragment basic instrument set
11 SET - LISTING FOR SET: SET-011-0010-004 large fragment basic instrument set used for 4.5 mm and 6.5 mm bone screws ref. - NO.: index - instruments: TRAY-011-0010-004 Graphic case ( tray in steel ) tray for basic instrument set - 1-Pcs. 005-0210-031 Drill bit - AO shaft ø 3.2 mm x length 145 mm / 120 mm - 3-Pcs. 005-0210-096 Malleolar countersink ø 3.2 mm - 1-Pcs. 005-0210-099 Countersink ø 4.5 mm with T-handle and tip - 1-Pcs. 005-0210-044 Drill bit - AO shaft ø 4.5 mm x length 145 mm / 120 mm - 2-Pcs. 005-0211-044 T-handle small with AO - quickcoupling - 1-Pcs. 005-0211-046 Tap - AO shaft ø 4.5 mm with cortical pitch 1.75 mm used for ø 4.5 mm cortical screws - 2-Pcs. 005-0211-066 Tap - AO shaft Ø 6.5 mm with cancellous pitch 2.75 mm - 1-Pcs. 005-0214-015 Large hexagonal screw driver - AO shaft standard ( hexagonal flats 3.5 mm) used for ø 4.5 mm / ø 6.5 mm screw - 1-Pcs. 005-0219-006 Depth gauge large, extra long for measurement 120 mm used for ø 4.5 mm and ø 6.5 mm screws - 1-Pcs. 005-0212-026 Tap sleeve, ø 3.5 mm, also for use as ø 3.2 mm drill guide - 1-Pcs. 005-0212-032 Insert drill sleeve, ø 4.5 mm / ø 3.2 mm - 1-Pcs. 005-0212-045 Tap sleeve, ø 4.5 mm - 1-Pcs. 005-0221-004 Drill sleeve for round hole plates - 1-Pcs. 005-0222-044 Universal drill guide ø 4.5 mm / ø 3.2 mm used for tap ø 4.5 mm and ø 3.2 mm drill bit applicable for neutral - load position - 1-Pcs. 009-0368-035 Large hexagonal screw driver for selfholding sleeve - 1-Pcs. 005-0221-012 Plate articulated tension device with joint, to tension of 20 mm also can be used as a distractor, color sale yellow up to 500N green up to 1000N, red over 1000N - 1-Pcs. 005-0221-016 Combination wrench width across flats 11 mm used for tension device REF. 005-0221-012 - 1-Pcs. 005-0221-015 Socket wrench, width across flats 11 mm used for tension device REF. 005-0221-012 - 1-Pcs. 005-0219-039 Sharp hook, length 155 mm - 1-Pcs. 005-0229-045 Bending template 5 holes used for large plates - 1-Pcs. 005-0229-047 Bending template 7 holes used for large plates - 1-Pcs. 005-0229-049 Bending template 9 holes used for large plates - 1-Pcs. 004-0310-020 K-wire ø 2.0 mm x 150 mm with trocar tip and round end - 10-Pcs. set-011-0010-004 large fragment basic instrument set
12 sterilization container for set-011-0010-004 Recommended sterilization container for Set-011-0010-010 ref. - NO.: sterilization container: cb-105-135 Container bottom non perforated 580 x 280 x 135 mm cl-100-010 Container lid perforated 580 x 280 mm
13 large fragment basic Instruments 005-0210-029 Drill bit - AO shaft ø 3.2 mm x length 195 mm / 170 mm 005-0210-031 Drill bit - AO shaft ø 3.2 mm x length 145 mm / 120 mm 005-0210-044 Drill bit - AO shaft ø 4.5 mm x length 145 mm / 120 mm 005-0210-096 Malleolar countersink ø 3.2 mm 005-0210-099 Countersink ø 4.5 mm with T-handle and tip 005-0211-044 T-handle small with AO - quickcoupling
14 large fragment basic Instruments 005-0211-046 Tap AO shaft ø 4.5 mm with cortical pitch 1.75 mm used for ø 4.5 mm cortical screws 005-0211-066 Tap - AO shaft ø 6.5 mm with cancellous pitch 2.75 mm 005-0214-015 Large hexagonal screw driver - AO shaft standard ( hexagonal flats 3.5 mm ) used for ø 4.5 mm / ø 6.5 mm screws 005-0219-006 Depth gauge large, extra long for measurement 120 mm used for ø 4.5 mm and 6.5 mm screws 005-0212-026 Tap sleeve, ø 3.5 mm, also for us as ø 3.2 mm drill guide - 1-Pcs.
15 large fragment basic Instruments 005-0212-032 Insert drill sleeve, ø 4.5 mm / ø 3.2 mm 005-0212-045 Tap sleeve, ø 4.5 mm 005-0221-004 Drill sleeve for round hole plates 005-0212-047 Pointed drill guide 005-0222-029 Drill guide 6.5 mm / 3.5 mm used for ø 6.5 mm screws and ø 3.5 mm drill bit
16 large fragment basic Instruments 009-0368-035 Large hexagonal screw driver used for selfholding sleeve REF.: 009-0390-062 009-0390-062 Coupling self - holding sleeve for screw driver REF. 009-0368-035 005-0222-044 Universal drill guide 4.5 mm / 3.2 mm used for tap ø 4.5 mm and ø 3.2 mm drill bit applicable for neutral - load position 005-0221-001 Drill sleeve for tension device
17 005-0221-012 Plate articulated tension device with joint, to tension of 20 mm also can be used as distractor, color scale yellow up to 500 N, green up to 100N, red over 100N large fragment basic Instruments 005-0221-016 Combination wrench width across flats 11 mm used for tension device REF. 005-0221-012 005-0221-015 Socket wrench, width across flats 11 mm used for tension device REF. 005-0221-012 005-0219-039 Sharp hook, length 155 mm
18 large fragment basic Instruments 005-0229-045 Bending template 5 holes used for large plates 005-0229-047 Bending template 7 holes used for large plates 005-0229-049 Bending template 9 holes used for large plates 004-0310-020 K - wire ø 2.0 mm x 150 mm with trocar tip and round end
19 index: Steel DHSp hip screw plates 130° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 38.0 mm Angel 130° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1066-04 4 holes x length 78 mm - 1-Pcs. AP-1066-05 5 holes x length 94 mm - 1-Pcs. AP-1066-06 6 holes x length 110 mm - 1-Pcs. AP-1066-07 7 holes x length 126 mm - 1-Pcs. AP-1066-08 8 holes x length 142 mm - 1-Pcs. AP-1066-10 10 holes x length 174 mm Steel DHSP hip screw plates 130°
20 index: Steel DHSp hip screw plates 135° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 38.0 mm Angel 135° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1065-02 2 hole x length 46 mm AP-1065-03 3 hole x length 62 mm AP-1065-04 4 hole x length 78 mm AP-1065-05 5 hole x length 94 mm AP-1065-06 6 hole x length 110 mm AP-1065-07 7 hole x length 126 mm AP-1065-08 8 hole x length 142 mm AP-1065-10 10 hole x length 174 mm AP-1065-12 12 hole x length 206 mm AP-1065-14 14 hole x length 238 mm AP-1065-16 16 hole x length 270 mm 135° Steel DHSP hip screw plates
21 index: Steel DHSp hip screw plates 140° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length 38.0 mm Angel 140° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1067-02 2 holes x length 46 mm AP-1067-04 4 holes x length 78 mm AP-1067-05 5 holes x length 94 mm AP-1067-06 6 holes x length 110 mm Steel DHSP hip screw plates 140° 145° index: Steel DHSp hip screw plates 145° ref. - NO.: Important technical dimensions:1Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length 38.0 mm Angel 145° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1068-00-02 2 hole x length 46 mm AP-1068-00-04 4 hole x length 78 mm AP-1068-00-05 5 hole x length 94 mm AP-1068-00-06 6 hole x length 110 mm
22 Steel DHSP hip screw plates 150° index: Steel DHSp hip screw plates 150° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 38.0 mm Angel 150° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1068-02 2 hole x length 46 mm AP-1068-04 4 hole x length 78 mm AP-1068-05 5 hole x length 94 mm AP-1068-06 6 hole x length 110 mm AP-1068-08 8 hole x length 142 mm AP-1068-10 10 hole x length 174 mm AP-1068-12 12 hole x length 206 mm
23 index: Steel DcSp condylar screw plates 95° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 25.0 mm Angel 95° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1069-06 6 holes x length 100 mm AP-1069-08 8 holes x length 130 mm AP-1069-10 10 holes x length 163 mm AP-1069-12 12 holes x length 198 mm AP-1069-14 14 holes x length 225 mm AP-1069-16 16 holes x length 260 mm AP-1069-18 18 holes x length 306 mm AP-1069-20 20 holes x length 338 mm AP-1069-22 22 holes x length 370 mm Steel DcSP condylar screw plates 95°
24 index: Steel DHSP / DcSp dynamic lag screws ref. - NO.: Important technical dimensions: Thread ø 12.5 mm Thread length 22.0 mm Pitch 3.0 mm Shaft ø 8.0 mm Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 LS-1001-050 Thread length 22 mm x length 50 mm LS-1001-055 Thread length 22 mm x length 55 mm LS-1001-060 Thread length 22 mm x length 60 mm LS-1001-065 Thread length 22 mm x length 65 mm LS-1001-070 Thread length 22 mm x length 70 mm LS-1001-075 Thread length 22 mm x length 75 mm LS-1001-080 Thread length 22 mm x length 80 mm LS-1001-085 Thread length 22 mm x length 85 mm LS-1001-090 Thread length 22 mm x length 90 mm LS-1001-095 Thread length 22 mm x length 95 mm LS-1001-100 Thread length 22 mm x length 100 mm LS-1001-105 Thread length 22 mm x length 105 mm LS-1001-110 Thread length 22 mm x length 110 mm LS-1001-115 Thread length 22 mm x length 115 mm LS-1001-120 Thread length 22 mm x length 120 mm LS-1001-125 Thread length 22 mm x length 125 mm LS-1001-130 Thread length 22 mm x length 130 mm LS-1001-135 Thread length 22 mm x length 135 mm LS-1001-140 Thread length 22 mm x length 140 mm LS-1001-145 Thread length 22 mm x length 145 mm Steel DhSP / dcsp dynamic lag screws index: Steel DHSP / DcSp compression screws ref. - NO.: Important technical dimensions: Thread ø 4.0 mm Full - threaded Length 36 mm Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 LS-1002-131 Steel DHSP / DCSP compression screw
25 set-011-0010-011 DHSP Standard implant set TRAY-011-0010-011 Graphic case ( tray in steel ) tray for DHSP implant set
26 set-011-0010-011 DHSP Standard implant set index: tray and implants TRAY-011-0010-011 Graphic case ( tray in steel ) tray for DHSP implant set - 1-Pcs. ref. - NO.: LS-1001-065 Thread length 22 mm x lenght 65 mm - 1-Pcs. LS-1001-070 Thread length 22 mm x lenght 70 mm - 1-Pcs. LS-1001-075 Thread length 22 mm x lenght 75 mm - 1-Pcs. LS-1001-080 Thread length 22 mm x lenght 80 mm - 1-Pcs. LS-1001-085 Thread length 22 mm x lenght 85 mm - 2-Pcs. LS-1001-090 Thread length 22 mm x lenght 90 mm - 2-Pcs. LS-1001-095 Thread length 22 mm x lenght 95 mm - 2-Pcs. LS-1001-100 Thread length 22 mm x lenght 100 mm - 2-Pcs. LS-1001-105 Thread length 22 mm x lenght 105 mm - 1-Pcs. LS-1001-110 Thread length 22 mm x lenght 110 mm - 1-Pcs. LS-1001-115 Thread length 22 mm x lenght 115 mm - 1-Pcs. index: tray and implants Steel DHSP / DCSP compression screw LS-1002-131 Steel DHSP / DCSP compression screw - 3-Pcs. index: steel dhsp hip screw plates 135° REF.: AP-1065-04 4 hole x length 78 mm - 3-Pcs. AP-1065-05 5 hole x length 94 mm - 2-Pcs. AP-1065-06 6 hole x length 110 mm - 2-Pcs. index: steel dhsp hip screw plates 150° ref. - NO.: AP-1068-04 4 hole x length 78 mm - 1-Pcs. AP-1068-05 5 hole x length 94 mm - 1-Pcs. AP-1068-06 6 hole x length 110 mm - 1-Pcs.
27 sterilization container for set-011-0010-011 Recommended sterilization container for Set-011-0010-004 ref. - NO.: sterilization container: cL-100-010 Container bottom non perforated 580 x 280 x 135 mm
28 set-011-0010-012 DCSP Standard implant set TRAY-011-0010-012 Graphic case ( tray in steel ) tray for DCSP implant set
29 set-011-0010-012 DCSP Standard implant set index: tray and implants TRAY-011-0010-012 Graphic case ( tray in steel ) tray for DCSP implant set - 1-Pcs. index: steel dhsp / dcsp DYNAMIC LAG SCREWS ref. - NO.: LS-1001-050 Thread length 22 mm x lenght 50 mm - 2-Pcs. LS-1001-055 Thread length 22 mm x lenght 55 mm - 2-Pcs. LS-1001-060 Thread length 22 mm x lenght 60 mm - 2-Pcs. LS-1001-065 Thread length 22 mm x lenght 65 mm - 2-Pcs. LS-1001-070 Thread length 22 mm x lenght 70 mm - 2-Pcs. LS-1001-075 Thread length 22 mm x lenght 75 mm - 1-Pcs. index: STEEL DHSP / DCSP COMPRESSION SCREW LS-1002-131 Steel DHSP / DCSP compression screw - 5-Pcs. index: steel dcsp CONDYLAR SCREW PLATES 95° REF.: AP-1069-06 6 hole x length 100 mm - 2-Pcs. AP-1069-08 8 hole x length 130 mm - 2-Pcs. AP-1069-10 10 hole x length 163 mm - 2-Pcs. AP-1069-12 12 hole x length 198 mm - 1-Pcs. AP-1069-14 14 hole x length 225 mm - 1-Pcs. AP-1069-16 16 hole x length 260 mm - 1-Pcs.
30 sterilization container for set-011-0010-012 Recommended sterilization container for Set-011-0010-012 ref. - NO.: sterilization container: cb-105-135 Container bottom non perforated 580 x 280 x 135 mm cl-100-010 Container lid perforated 580 x 280 mm
31 Notice:
MEDICAL ADVANCED TECHNOLOGY MAT GmbH&Co.KG Friedrich-Wöhler Straße 10 78576 Emmingen-Liptingen, Germany Phone: +49 (0)7465 909 188 · Fax : +49 (0)7465 909 024 www.mat-medical.com · info@mat-medical.com Revision 18.03.2010DHSP / DCSP © MAT

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2 brochure dhsp-dcsp

  • 1.
    MEDICAL ADVANCED TECHNOLOGY STEELDHSP / DCSP DYNAMIC HIP - AND CONDYLAR SCREW PLATE SYSTEM IncludeS basic large fragment instruments
  • 2.
    2 Contact Friedrich-Wöhler-Straße 10 78576 Emmingen,Germany phone +49(0)74 65 / 909188 Fax +49(0)74 65 / 909024 Internet info@mat-medical.com Manual for use under our Hompage: www.mat-medical.com INSTRUCTIONS FOR USE 3. (GB) Warning: The implants described may only be used in combination with MAT products! OSTEOSYNTHESIS – STEEL IMPLANTS (Bone: Plates / Screws / Pins / Wires / Clips) non-sterile IMPLANT MATERIAL: Implants made from steel in accordance with ISO 5832 – 1 stainless steel ; ISO 5832 – 9 high nitrogen stainless steel manufactured by MAT MEDICAL AD- VANCED TECHNOLOGY. The surface of these implants is chemically passive: not magnetic. These implants can be combined with the standardised material provided that its composition lies within the analysis stipulated in the ISO 5832 – 1 / ISO 5832 – 9 standard and the required specifications. Material alloys with chrome-nickel (implant steel) components can trigger a so-called chrome-nickel allergy by their nature; there are no other known biocompatible hazards! We would point out that implants only function correctly if the following basic rules are observed: - When selecting implants (bone: plates / screws / pins wires / clips), care must be taken to choose the appropriate implants on the basis of the weight and level of activity of the patient, and the bone fracture to be treated. - Note that by making the correct choice of biomechanics the forces to be transferred by the implants remain low. - Extreme deformation of the implants must be avoided; the cautious bending of wires, plates and pins does not, however, lead to implant damage provided it is done with sufficient care. - Repeated deformation should be avoided at all costs as it will fatigue the implant material. - The re-use of implants is absolutely forbidden (single use). - We strongly advise you to inform patients of the advantages and disadvantages of implants. - Excessive strain as a result of body weight and the level of activity of the patient should be avoided due to the limited strength of the im plants. Failure to observe these precautionary measures can have serious consequences for the healing process. INDICATIONS These relate to the current practice of applications of implants in osteosynthesis (e.g. see literature AO/ASIF Instruments and Implants Texhammer*Colton ISBN 3-540-56895-6 / ISBN 0-387-56895-6). CONTRAINDICATIONS Acute and chronic infections; muscle, nerve or vascular diseases that endanger the affected extremity; a lack of bony tissue or poor bone quality (e.g. severe osteoporosis); local bone tumours. Systemic diseases and metabolic disorders; infections and falls; drug dependence; obesity; highly physical activities together with activities involving extreme vibrations which can lead to overstraining of the implants. NOTES The user should record and keep all information provided to the patient. It should be checked before use whether the patient tolerates the material to be implan- ted. The implants described in these instructions for use may only be used (implanted) by surgeons with the appropriate experience. POSSIBLE NEGATIVE EFFECTS (RISKS) Failure of the fracture to heal, allergy to the material, failure of the product (break, bending), bone deformation and refracture, infection. REMOVAL OF IMPLANTS The implants are normally removed once the fracture has healed. CLEANING AND STERILISATION OF UNSTERILE IMPLANTS Before use, the implants must be sterilised using a validated procedure (autoclaved). MAT MEDICAL ADVANCED TECHNOLOGY VALIDATED PROCEDURES STERILISER: Steam autoclave: Temperature = 121° to 123° Celsius; Pressure = 1-1.2 bar (15 to 17 psi) with an exposure time of at least 30 minutes in the packaged state. STERILISER: Autoclave with prevacuum: During the prevacuum phase the air is extracted from the chamber before the steam flows in. Standard circulation for packaged objects: 132° to 135° Celsius; Pressure = 2 – 3 bar (27 to 30 psi) with an exposure time of at least 4 to 10 minutes. IMPORTANT NOTES: Every time the implants are used or sterilised you must first check that they function perfectly! In the event of failure to observe these instructions or demonstrable violation, no guarantee or compensation for damages can be provided. LARGE fragment Manual for use 3.
  • 3.
    3 SET - LISTINGFOR SET: SET-011-0010-010 dhsp / dcsp instrument set complete ref. - NO.: index - instruments: TRAY-011-0010-010 Graphic case (tray in steel) tray for DHSP / DCSP instrument - 1-Pcs. 006-0010-002 Calibrated threaded Guide Pin ø 2.5 mm x length 230 mm -10-Pcs. 006-0010-004 Drill guide adjustable 125° up to 150° - 1-Pcs. 006-0010-006 Direct measuring device - 1-Pcs. 006-0010-007 Angled drill guide for condylar plates 95° - 1-Pcs. 006-0010-008 Triple reamer complete for dynamic hip screw plates - 1-Pcs. 006-0010-009 Triple reamer compolete for dynamic dondylar screw plates - 1-Pcs. 006-0010-010 Tap for lag screws - 1-Pcs. 006-0010-012 Centring sleeve short for used tap - 1-Pcs. 006-0010-014 Centring sleeve long for used wrench - 1-Pcs. 006-0010-016 Guide shaft for coupling screw short - 1-Pcs. 006-0010-018 Coupling screw for wrench - 1-Pcs. 006-0010-020 Coupling screw short for guide shaft - 2-Pcs. 006-0010-022 Wrench for used assembled guide shaft short with coupling screw - 1-Pcs. 006-0010-024 Impactor - 1-Pcs. 006-0010-026 T-handle with quick coupling - 1-Pcs. set-011-0010-010 dhsp / dcsp instrument set
  • 4.
    4 set-011-0010-010 Dhsp /dcsp instrument set TRAY-011-0010-010 Graphic case ( tray in steel ) tray for DHSP / DCSP instrument
  • 5.
    5 sterilization container forset-011-0010-010 Recommended sterilization container for Set-011-0010-010 ref. - NO.: sterilization container: cb-105-135 Container bottom non perforated 580 x 280 x 135 mm cl-100-010 Container lid perforated 580 x 280 mm
  • 6.
    6 DHSP / DCSP- Instruments 006-0010-004 Drill guide adjustable 125° up to 150° 006-0010-005 Drill guide adjustable 125° up to 150° used for three guide pins ( without picture ) 006-0010-002 Calibrated threaded Guide Pin ø 2.5 mm x length 230 mm 006-0010-007 Angled drill guide for condylar plates 95°
  • 7.
    7 Instruments 006-0010-006 Direct measuringdevice 006-0010-008 Triple reamer complete for dynamic hip screw plates - DHSP 006-0010-009 Triple reamer complete for dynamic hip condylar screw plates - DCSP 006-0010-010 Tap for lag screws
  • 8.
    8 006-0010-012 Centering sleeveshort for used tap 006-0010-014 Centering sleeve long for used wrench 006-0010-016 Guide shaft used for coupling screw short REF.: 006-0010-020 006-0010-018 Coupling screw used for wrench REF.: 006-0010-022 dhsp / DCSP - Instruments
  • 9.
    9 dhsp / DCSP- Instruments 006-0010-020 Coupling screw short for guide shaft 006-0010-022 Wrench for used assembled guide shaft short with coupling screw 006-0010-024 Impactor 006-0010-026 T-handle with quick coupling
  • 10.
  • 11.
    11 SET - LISTINGFOR SET: SET-011-0010-004 large fragment basic instrument set used for 4.5 mm and 6.5 mm bone screws ref. - NO.: index - instruments: TRAY-011-0010-004 Graphic case ( tray in steel ) tray for basic instrument set - 1-Pcs. 005-0210-031 Drill bit - AO shaft ø 3.2 mm x length 145 mm / 120 mm - 3-Pcs. 005-0210-096 Malleolar countersink ø 3.2 mm - 1-Pcs. 005-0210-099 Countersink ø 4.5 mm with T-handle and tip - 1-Pcs. 005-0210-044 Drill bit - AO shaft ø 4.5 mm x length 145 mm / 120 mm - 2-Pcs. 005-0211-044 T-handle small with AO - quickcoupling - 1-Pcs. 005-0211-046 Tap - AO shaft ø 4.5 mm with cortical pitch 1.75 mm used for ø 4.5 mm cortical screws - 2-Pcs. 005-0211-066 Tap - AO shaft Ø 6.5 mm with cancellous pitch 2.75 mm - 1-Pcs. 005-0214-015 Large hexagonal screw driver - AO shaft standard ( hexagonal flats 3.5 mm) used for ø 4.5 mm / ø 6.5 mm screw - 1-Pcs. 005-0219-006 Depth gauge large, extra long for measurement 120 mm used for ø 4.5 mm and ø 6.5 mm screws - 1-Pcs. 005-0212-026 Tap sleeve, ø 3.5 mm, also for use as ø 3.2 mm drill guide - 1-Pcs. 005-0212-032 Insert drill sleeve, ø 4.5 mm / ø 3.2 mm - 1-Pcs. 005-0212-045 Tap sleeve, ø 4.5 mm - 1-Pcs. 005-0221-004 Drill sleeve for round hole plates - 1-Pcs. 005-0222-044 Universal drill guide ø 4.5 mm / ø 3.2 mm used for tap ø 4.5 mm and ø 3.2 mm drill bit applicable for neutral - load position - 1-Pcs. 009-0368-035 Large hexagonal screw driver for selfholding sleeve - 1-Pcs. 005-0221-012 Plate articulated tension device with joint, to tension of 20 mm also can be used as a distractor, color sale yellow up to 500N green up to 1000N, red over 1000N - 1-Pcs. 005-0221-016 Combination wrench width across flats 11 mm used for tension device REF. 005-0221-012 - 1-Pcs. 005-0221-015 Socket wrench, width across flats 11 mm used for tension device REF. 005-0221-012 - 1-Pcs. 005-0219-039 Sharp hook, length 155 mm - 1-Pcs. 005-0229-045 Bending template 5 holes used for large plates - 1-Pcs. 005-0229-047 Bending template 7 holes used for large plates - 1-Pcs. 005-0229-049 Bending template 9 holes used for large plates - 1-Pcs. 004-0310-020 K-wire ø 2.0 mm x 150 mm with trocar tip and round end - 10-Pcs. set-011-0010-004 large fragment basic instrument set
  • 12.
    12 sterilization container forset-011-0010-004 Recommended sterilization container for Set-011-0010-010 ref. - NO.: sterilization container: cb-105-135 Container bottom non perforated 580 x 280 x 135 mm cl-100-010 Container lid perforated 580 x 280 mm
  • 13.
    13 large fragment basicInstruments 005-0210-029 Drill bit - AO shaft ø 3.2 mm x length 195 mm / 170 mm 005-0210-031 Drill bit - AO shaft ø 3.2 mm x length 145 mm / 120 mm 005-0210-044 Drill bit - AO shaft ø 4.5 mm x length 145 mm / 120 mm 005-0210-096 Malleolar countersink ø 3.2 mm 005-0210-099 Countersink ø 4.5 mm with T-handle and tip 005-0211-044 T-handle small with AO - quickcoupling
  • 14.
    14 large fragment basicInstruments 005-0211-046 Tap AO shaft ø 4.5 mm with cortical pitch 1.75 mm used for ø 4.5 mm cortical screws 005-0211-066 Tap - AO shaft ø 6.5 mm with cancellous pitch 2.75 mm 005-0214-015 Large hexagonal screw driver - AO shaft standard ( hexagonal flats 3.5 mm ) used for ø 4.5 mm / ø 6.5 mm screws 005-0219-006 Depth gauge large, extra long for measurement 120 mm used for ø 4.5 mm and 6.5 mm screws 005-0212-026 Tap sleeve, ø 3.5 mm, also for us as ø 3.2 mm drill guide - 1-Pcs.
  • 15.
    15 large fragment basicInstruments 005-0212-032 Insert drill sleeve, ø 4.5 mm / ø 3.2 mm 005-0212-045 Tap sleeve, ø 4.5 mm 005-0221-004 Drill sleeve for round hole plates 005-0212-047 Pointed drill guide 005-0222-029 Drill guide 6.5 mm / 3.5 mm used for ø 6.5 mm screws and ø 3.5 mm drill bit
  • 16.
    16 large fragment basicInstruments 009-0368-035 Large hexagonal screw driver used for selfholding sleeve REF.: 009-0390-062 009-0390-062 Coupling self - holding sleeve for screw driver REF. 009-0368-035 005-0222-044 Universal drill guide 4.5 mm / 3.2 mm used for tap ø 4.5 mm and ø 3.2 mm drill bit applicable for neutral - load position 005-0221-001 Drill sleeve for tension device
  • 17.
    17 005-0221-012 Plate articulatedtension device with joint, to tension of 20 mm also can be used as distractor, color scale yellow up to 500 N, green up to 100N, red over 100N large fragment basic Instruments 005-0221-016 Combination wrench width across flats 11 mm used for tension device REF. 005-0221-012 005-0221-015 Socket wrench, width across flats 11 mm used for tension device REF. 005-0221-012 005-0219-039 Sharp hook, length 155 mm
  • 18.
    18 large fragment basicInstruments 005-0229-045 Bending template 5 holes used for large plates 005-0229-047 Bending template 7 holes used for large plates 005-0229-049 Bending template 9 holes used for large plates 004-0310-020 K - wire ø 2.0 mm x 150 mm with trocar tip and round end
  • 19.
    19 index: Steel DHSphip screw plates 130° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 38.0 mm Angel 130° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1066-04 4 holes x length 78 mm - 1-Pcs. AP-1066-05 5 holes x length 94 mm - 1-Pcs. AP-1066-06 6 holes x length 110 mm - 1-Pcs. AP-1066-07 7 holes x length 126 mm - 1-Pcs. AP-1066-08 8 holes x length 142 mm - 1-Pcs. AP-1066-10 10 holes x length 174 mm Steel DHSP hip screw plates 130°
  • 20.
    20 index: Steel DHSphip screw plates 135° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 38.0 mm Angel 135° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1065-02 2 hole x length 46 mm AP-1065-03 3 hole x length 62 mm AP-1065-04 4 hole x length 78 mm AP-1065-05 5 hole x length 94 mm AP-1065-06 6 hole x length 110 mm AP-1065-07 7 hole x length 126 mm AP-1065-08 8 hole x length 142 mm AP-1065-10 10 hole x length 174 mm AP-1065-12 12 hole x length 206 mm AP-1065-14 14 hole x length 238 mm AP-1065-16 16 hole x length 270 mm 135° Steel DHSP hip screw plates
  • 21.
    21 index: Steel DHSphip screw plates 140° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length 38.0 mm Angel 140° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1067-02 2 holes x length 46 mm AP-1067-04 4 holes x length 78 mm AP-1067-05 5 holes x length 94 mm AP-1067-06 6 holes x length 110 mm Steel DHSP hip screw plates 140° 145° index: Steel DHSp hip screw plates 145° ref. - NO.: Important technical dimensions:1Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length 38.0 mm Angel 145° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1068-00-02 2 hole x length 46 mm AP-1068-00-04 4 hole x length 78 mm AP-1068-00-05 5 hole x length 94 mm AP-1068-00-06 6 hole x length 110 mm
  • 22.
    22 Steel DHSP hipscrew plates 150° index: Steel DHSp hip screw plates 150° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 38.0 mm Angel 150° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1068-02 2 hole x length 46 mm AP-1068-04 4 hole x length 78 mm AP-1068-05 5 hole x length 94 mm AP-1068-06 6 hole x length 110 mm AP-1068-08 8 hole x length 142 mm AP-1068-10 10 hole x length 174 mm AP-1068-12 12 hole x length 206 mm
  • 23.
    23 index: Steel DcSpcondylar screw plates 95° ref. - NO.: Important technical dimensions: Thickness 5.8 mm profile Broad 19.0 mm profile Distance between holes 16.0 mm Barrel outer ø 12.6 mm Barrel length ø 25.0 mm Angel 95° Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 AP-1069-06 6 holes x length 100 mm AP-1069-08 8 holes x length 130 mm AP-1069-10 10 holes x length 163 mm AP-1069-12 12 holes x length 198 mm AP-1069-14 14 holes x length 225 mm AP-1069-16 16 holes x length 260 mm AP-1069-18 18 holes x length 306 mm AP-1069-20 20 holes x length 338 mm AP-1069-22 22 holes x length 370 mm Steel DcSP condylar screw plates 95°
  • 24.
    24 index: Steel DHSP/ DcSp dynamic lag screws ref. - NO.: Important technical dimensions: Thread ø 12.5 mm Thread length 22.0 mm Pitch 3.0 mm Shaft ø 8.0 mm Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 LS-1001-050 Thread length 22 mm x length 50 mm LS-1001-055 Thread length 22 mm x length 55 mm LS-1001-060 Thread length 22 mm x length 60 mm LS-1001-065 Thread length 22 mm x length 65 mm LS-1001-070 Thread length 22 mm x length 70 mm LS-1001-075 Thread length 22 mm x length 75 mm LS-1001-080 Thread length 22 mm x length 80 mm LS-1001-085 Thread length 22 mm x length 85 mm LS-1001-090 Thread length 22 mm x length 90 mm LS-1001-095 Thread length 22 mm x length 95 mm LS-1001-100 Thread length 22 mm x length 100 mm LS-1001-105 Thread length 22 mm x length 105 mm LS-1001-110 Thread length 22 mm x length 110 mm LS-1001-115 Thread length 22 mm x length 115 mm LS-1001-120 Thread length 22 mm x length 120 mm LS-1001-125 Thread length 22 mm x length 125 mm LS-1001-130 Thread length 22 mm x length 130 mm LS-1001-135 Thread length 22 mm x length 135 mm LS-1001-140 Thread length 22 mm x length 140 mm LS-1001-145 Thread length 22 mm x length 145 mm Steel DhSP / dcsp dynamic lag screws index: Steel DHSP / DcSp compression screws ref. - NO.: Important technical dimensions: Thread ø 4.0 mm Full - threaded Length 36 mm Material alloyed steel ISO 5832-1 according to biocompatibility ISO 10993-1 LS-1002-131 Steel DHSP / DCSP compression screw
  • 25.
    25 set-011-0010-011 DHSP Standardimplant set TRAY-011-0010-011 Graphic case ( tray in steel ) tray for DHSP implant set
  • 26.
    26 set-011-0010-011 DHSP Standardimplant set index: tray and implants TRAY-011-0010-011 Graphic case ( tray in steel ) tray for DHSP implant set - 1-Pcs. ref. - NO.: LS-1001-065 Thread length 22 mm x lenght 65 mm - 1-Pcs. LS-1001-070 Thread length 22 mm x lenght 70 mm - 1-Pcs. LS-1001-075 Thread length 22 mm x lenght 75 mm - 1-Pcs. LS-1001-080 Thread length 22 mm x lenght 80 mm - 1-Pcs. LS-1001-085 Thread length 22 mm x lenght 85 mm - 2-Pcs. LS-1001-090 Thread length 22 mm x lenght 90 mm - 2-Pcs. LS-1001-095 Thread length 22 mm x lenght 95 mm - 2-Pcs. LS-1001-100 Thread length 22 mm x lenght 100 mm - 2-Pcs. LS-1001-105 Thread length 22 mm x lenght 105 mm - 1-Pcs. LS-1001-110 Thread length 22 mm x lenght 110 mm - 1-Pcs. LS-1001-115 Thread length 22 mm x lenght 115 mm - 1-Pcs. index: tray and implants Steel DHSP / DCSP compression screw LS-1002-131 Steel DHSP / DCSP compression screw - 3-Pcs. index: steel dhsp hip screw plates 135° REF.: AP-1065-04 4 hole x length 78 mm - 3-Pcs. AP-1065-05 5 hole x length 94 mm - 2-Pcs. AP-1065-06 6 hole x length 110 mm - 2-Pcs. index: steel dhsp hip screw plates 150° ref. - NO.: AP-1068-04 4 hole x length 78 mm - 1-Pcs. AP-1068-05 5 hole x length 94 mm - 1-Pcs. AP-1068-06 6 hole x length 110 mm - 1-Pcs.
  • 27.
    27 sterilization container forset-011-0010-011 Recommended sterilization container for Set-011-0010-004 ref. - NO.: sterilization container: cL-100-010 Container bottom non perforated 580 x 280 x 135 mm
  • 28.
    28 set-011-0010-012 DCSP Standardimplant set TRAY-011-0010-012 Graphic case ( tray in steel ) tray for DCSP implant set
  • 29.
    29 set-011-0010-012 DCSP Standardimplant set index: tray and implants TRAY-011-0010-012 Graphic case ( tray in steel ) tray for DCSP implant set - 1-Pcs. index: steel dhsp / dcsp DYNAMIC LAG SCREWS ref. - NO.: LS-1001-050 Thread length 22 mm x lenght 50 mm - 2-Pcs. LS-1001-055 Thread length 22 mm x lenght 55 mm - 2-Pcs. LS-1001-060 Thread length 22 mm x lenght 60 mm - 2-Pcs. LS-1001-065 Thread length 22 mm x lenght 65 mm - 2-Pcs. LS-1001-070 Thread length 22 mm x lenght 70 mm - 2-Pcs. LS-1001-075 Thread length 22 mm x lenght 75 mm - 1-Pcs. index: STEEL DHSP / DCSP COMPRESSION SCREW LS-1002-131 Steel DHSP / DCSP compression screw - 5-Pcs. index: steel dcsp CONDYLAR SCREW PLATES 95° REF.: AP-1069-06 6 hole x length 100 mm - 2-Pcs. AP-1069-08 8 hole x length 130 mm - 2-Pcs. AP-1069-10 10 hole x length 163 mm - 2-Pcs. AP-1069-12 12 hole x length 198 mm - 1-Pcs. AP-1069-14 14 hole x length 225 mm - 1-Pcs. AP-1069-16 16 hole x length 260 mm - 1-Pcs.
  • 30.
    30 sterilization container forset-011-0010-012 Recommended sterilization container for Set-011-0010-012 ref. - NO.: sterilization container: cb-105-135 Container bottom non perforated 580 x 280 x 135 mm cl-100-010 Container lid perforated 580 x 280 mm
  • 31.
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