OSCAR
OSCAR 3 Operative Room Training Rev A April 2019
Operative Room Training
12 Pages
Preview
Page 1
OPERATIVE ROOM TRAINING
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2
CONTENTS
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5
10
COMPONENTS
PROBE SELECTION
3
Overview
4
Instruments
4
Handsets
5
Cement Removal
6
Bone Cutting
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Probe Configuration
7
Extension Bars
THEATRE SET-UP
OSCAR has been designed and built in accordance with ISO 13485:2003 Quality Assurance standard for medical devices and Part 820 of the Title 21 of the Code of Federal Regulations of the USA. CE conformance has been certified and the equipment complies with BSEN60601-1.
OPERATIVE ROOM TRAINING
COMPONENTS Overview
OSCAR Generator • Requires access to mains power • MUST be outside the sterile field
OSCAR Sterilisation Tray • Contents: handsets, cables and tools • MUST be kept sterile for use in sterile field
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OPERATIVE ROOM TRAINING
Instruments
Tray Contents: • 3 Handsets: 2x cement removal (sliver) and 1x bone cutting (gold) • 2x cables • 1x Slap Hammer • Spanners: 2x 8/9mm and 1x 7mm
Handsets OSCAR Cement Removal Probes • • • • •
Individually packed, sterile and single-use Cement removal ONLY Use with cement removal handset ONLY Screw directly onto the handset or via extension bars Variations include: • Groover probes • Scraper probes • Piercer probes • Acetabular probes
OSCAR Bone Cutting Probes • • • • • •
Individually packed, sterile and single-use Bone cutting (uncemented revisions) ONLY Used with bone cutting (gold) handset ONLY Screw directly onto the handset No extension bars required Three variations: • Flat • Serrated • Curved Serrated
OPERATIVE ROOM TRAINING
PROBE SELECTION Cement Removal Scraper
Piercer • • •
Designed to create clear channels in the cement Molten excess cement is cleared through the perforations in the head of the probe Options: • 6mm Ø 180mmL OHP2062SU • 8mm Ø 80mmL OHP2080SU • 10mm Ø 80mmL OHP2100SU • Flat 96mmL OHP218FSU
• • • •
Acetabular
Hoe • •
•
Designed to remove cement in narrow canals, such as the upper limb The probe is advanced down a channel and drawn smoothly backwards, collecting excess cement in the recess between the probed head and stem Options: • 6mm Ø 180mmL OHH2062SU • 8mm Ø 180mmL OHH2081SU
• • •
• •
Designed to make longitudinal channels in the cement The probe is advanced into the cement, using the cutting blades on the lateral aspects of the probe head Excess molten cement is cleared through the perforations in the head of the probe • OHG2020SU
Designed to create channels in cement bonding the acetabular component The probe is advanced in line with the curvature of acetabular cup circumferentially around the acetabulum Options: • 100 mmL OHA2030SU
Extraction and Slap Hammer
Groover •
Designed to clear channels of excess cement The probe is advanced down a channel and drawn smoothly backwards, collecting excess cement in the recess between the probed head and stem Options: • 6mm Ø 180mmL OHS2062SU • 8mm Ø 80mmL OHS2080SU • 10mm Ø 80mmL OHS2100SU
• • •
Designed to remove large intact pieces of cement and cement plugs The probe is advanced into the cement and left to re-solidly around the head The handset is removed and the slam hammer is screwed in used to mechanically draw out the cement • EXP2681SU
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OPERATIVE ROOM TRAINING
Bone Cutting Osteotomes • • •
Designed to remove osseointegrated prostheses The thin probes have serrated edges which can be advanced through the cancellous bone prosthesis interface Options: • Flat OHFO2060SU • Serrated OHSO2060SU • Curved Serrated OHC2SO2060SU
Example of probe configuration Flight Case 8mm Piercer OHP2080SU
6mm Hoe OHH2062SU
8mm Piercer OHP2080SU
6mm Hoe OHH2062SU
8mm Scraper OHS2080SU
Extraction EXP2681SU
8mm Scraper OHS2080SU
Extraction EXP2681SU
10mm Piercer OHP2100SU
6mm Flat Osteotome OHFO2060SU 6mm Flat Osteotome OHFO2060SU 6mm Flat Osteotome OHFO2060SU 6mm Serrated Osteotome OHSO2060SU
10mm Piercer OHP2100SU 10mm Scraper OHS2100SU FRONT
Acetabular OHA2030SU
6mm Serrated Osteotome OHSO2060SU 6mm Serrated Osteotome OHSO2060SU 6mm Curved Serrated Osteotome OHC2SO2060SU 6mm Curved Serrated Osteotome OHC2SO2060SU
6mm Slim Steam Piercer OHP2062SU
6mm Curved Serrated Osteotome OHC2SO2060SU
10mm Scraper OHS2100SU
6mm Slim Steam Piercer OHP2062SU
8mm Flat Piercer OHP218FSU
6mm Slim Steam Scraper OHS2062SU 6mm Slim Steam Scraper OHS2062SU
8mm Flat Piercer OHP218FSU
See Over Page for re-usable Probes an other components included in autoclave tray. For use with Bone Cutting Osteotome ONLY
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OPERATIVE ROOM TRAINING
Extension Bars Flat Piercer Probes •
Flat 96mm L OHP218FSU MUST USE REDUCER BAR OHR2000
Extraction Probes •
EXP2681SU OPTIONAL USE WITH EXTENSION REDUCER BAR OHE2000
Acetabular Probe •
100 mmL OHA2030SU OPTIONAL USE WITH EXTENSION REDUCER BAR OHE2000
OPERATIVE ROOM TRAINING
Use with Extension/Reduce Bars.
Probe ID
Probe Name
OHR2000 Reducer Bar
OHRE2000SU OHRE2002SU Short Extension Bar
OHRE2001SU OHRE2003SU Long Extension Bar
Use without Extension/reducer Bar
OHE2000 Standard Extension Bar
OHP218FSU
8mm Flat Piercer
YES
NO
NO
NO
NO
OHP2080SU
8mm Piercer
NO
YES
YES
NO
NO
OHS2080SU
8mm Scraper
NO
YES
YES
NO
NO
OHP2062SU
Slim 6mm Piercer
NO
NO
NO
YES
NO
OHP2100SU
10mm Piercer
NO
YES
YES
NO
NO
OHS2100SU
10mm Scraper
NO
YES
YES
NO
NO
OHS2062SU
Slim 6mm Scraper
NO
NO
NO
YES
NO
OHA2030SU
Acetabular Probe
NO
NO
NO
YES
YES (Optional)
OHH2062SU
6mm hoe Probe
NO
NO
NO
YES
NO
OHH2081SU
8mm Hoe Probe
NO
NO
NO
YES
NO
EXP2681SU
Extraction Probe
NO
NO
NO
YES
YES (Optional)
Osteotome Probes • • •
Flat OHFO2060SU CAN USE WITH OR WITHOUT BONECUTTER EXTENSION BAR OBE2000 Serrated OHSO2060SU CAN USE WITH OR WITHOUT BONECUTTER EXTENSION BAR OBE2000 Curved Serrated OHC2SO2060SU CAN USE WITH OR WITHOUT BONECUTTER EXTENSION BAR OBE2000
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10 OPERATIVE ROOM TRAINING
Theatre Set-Up
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Plug one end of the cable into the channel ports on the generator and air nozzle hose from the footswitch
NON-STERILE STERILE
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Plug the alternate end of the cable into the each handset (sterile)
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Align the red dots and press together, listening for a click to ensure a stable connection
(Note there is a collar on the connectors this needs to be pulled to remove the connection. Connectors must not be removed by twisting or the pulling the cable)
OPERATIVE ROOM TRAINING
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Screw in the intended probe to the handset using the spanners provided. Do not overtighten.
STERILE NON-STERILE
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Activate the generator using the ON/OFF switch at the rear
LED light indicator Blue = when handset selected Yellow = when handset is active Handset are selected by pressing central button with a tactile “click”
Please visit http://web.orthofix.com/sites/Country/Intl/Products/Pages/OSCAR3-Lower.aspx?catid=29 for full information on indications for use, contraindications, warnings, precautions, adverse reactions information, and sterilization.
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Distributed by:
Manufactured by: ORTHOFIX Srl Via Delle Nazioni 9, 37012 Bussolengo (Verona), Italy Telephone +39 045 6719000, Fax +39 045 6719380 0123
www.orthofix.com OS-1901-PL-E0 A 04/19
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Proper surgical procedure is the responsibility of the medical professional. Operative techniques are furnished as an informative guideline. Each surgeon must evaluate the appropriateness of a technique based on his or her personal medical credentials and experience. Please refer to the “Instructions for Use” supplied with the product for specific information on indications for use, contraindications, warnings, precautions, adverse reactions and sterilization.