User Guide
94 Pages
Preview
Page 1
HIP
Instrument User Guide Revision 1.3 Date of issue: 2020-06-08 (ISO 8601) Copyright 2020, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
TABLE OF CONTENTS 1 GENERAL INFORMATION...5 1.1 Contact Data ...5 1.2 Legal Information ...7 1.3 Symbols ...8 1.4 Using the System ...11 1.5 Training and Documentation...12
2 INSTRUMENTATION OVERVIEW...13 2.1 Instrument Handling ...13 2.1.1 Using Fixation Pins ...14 2.1.2 Available Instruments ...15
3 GENERAL INSTRUMENTATION ...19 3.1 Disposable Reflective Marker Spheres ...19 3.1.1 Using Marker Spheres...20
3.2 Disposable Schanz Screws ...22 3.3 Pin Driver Adapter for AO Coupling (54932) ...23
4 POINTERS ...25 4.1 Using Pointers...25 4.1.1 Handling Pointers...25 4.1.2 Maintaining Pointer Accuracy ...26
4.2 Pointer for Hip ...27 4.3 Disposable Clip-on Remote Control (53153) ...28 4.3.1 Overview ...28 4.3.2 Attaching the Disposable Clip-on Remote Control...29 4.3.3 Using the Disposable Clip-on Remote Control...31 4.3.4 After Use ...32 4.3.5 Technical Specifications ...33 4.3.6 Electromagnetic Compatibility and Emissions ...35 4.3.7 Electromagnetic Immunity ...36 4.3.8 RF Communications Equipment ...38
4.4 Footswitch (USB) (18460) ...39
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TABLE OF CONTENTS
5 CALIPER FOR PELVIS ...41 5.1 Caliper for Pelvis (52876) ...41
6 REFERENCE ARRAYS, X-PRESS...43 6.1 Instrument Overview...43 6.1.1 Reference Array, X-Press Kits ...45
6.2 Bone Fixators, X-Press ...46 6.2.1 Overview ...46 6.2.2 Using Schanz Screws with Bone Fixators ...47 6.2.3 Using the Bone Fixator 1-Pin X-Press ...49 6.2.4 Bone Fixator 2-Pin, Flip-Flop, X-Press (52429) ...53 6.2.5 Using the 2-Pin Drill Template X-Press (52425) (Optional) ...54 6.2.6 Attaching the Bone Fixator 2-Pin, Flip-Flop, X-Press...55
6.3 Reference Arrays, X-Press ...57 6.3.1 Reference Array, X-Press Overview ...57 6.3.2 Attaching and Detaching the Reference Array...59 6.3.3 Preparation for Registration...61
7 REFERENCE ARRAY PINLESS FEMUR ...65 7.1 Instrument Overview...65 7.2 Attaching the Base Plate and Reference Array ...67
8 INSTRUMENT ADAPTERS...69 8.1 Using Adapters ...69 8.2 Reference Array StarLock for Cup Impactor Universal (55085) ...70
9 SURGICAL INSTRUMENTS ...73 9.1 Cup Impactor Universal Offset (52856) ...73 9.1.1 Assembling and Disassembling the Cup Impactor Universal Offset...75 9.1.2 Affixing and Locking the Implant on the Impactor ...78 9.1.3 Steps Prior to Impaction ...79 9.1.4 Releasing the Implant after Impaction ...81
9.2 Cup Impactor Universal Straight (52858) ...82 9.2.1 Adding and Removing the Impactor Nosepiece...85 9.2.2 Affixing and Locking the Implant on the Impactor (Symmetrical Nosepiece) ...86 9.2.3 Steps Prior to Impaction ...87 9.2.4 Releasing the Implant after Impaction ...88
9.3 Insert For Universal Cup Impactor (52855) ...89
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Instrument User Guide Rev. 1.3 Hip
GENERAL INFORMATION
1
GENERAL INFORMATION
1.1
Contact Data
Support If you cannot find information you need in this guide, or if you have questions or problems, contact Smith+Nephew support: Region
Telephone and Fax
Global Support
Tel: +1 833 766 2846 Fax: +1 763 452 4980
Expected Service Life Unless specifically stated otherwise, eight years of service are provided.
Feedback Despite careful review, this user guide may contain errors. Please contact us at [email protected] if you have improvement suggestions.
Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany
Manufacturer Contact Region
Telephone and Fax
United States, Canada, Central Tel: +1 800 597 5911 and South America Fax: +1 708 409 1619
Brazil
Tel: (0800) 892 1217
UK
Tel: +44 1223 755 333
Spain
Tel: +34 900 649 115
France and French-speaking regions
Tel: +33 800 676 030
Africa, Asia, Australia, Europe
Tel: +49 89 991568 1044 Fax: +49 89 991568 811
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Contact Data
6
Region
Telephone and Fax
Japan
Tel: +81 3 3769 6900 Fax: +81 3 3769 6901
Instrument User Guide Rev. 1.3 Hip
GENERAL INFORMATION
1.2
Legal Information
Copyright This guide contains proprietary information protected by copyright. No part of this guide may be reproduced or translated without express written permission of Brainlab.
Brainlab Trademarks • Brainlab® is a registered trademark of Brainlab AG in Germany and/or the US. • Buzz® Navigation (Ceiling-Mounted) is a registered trademark of Brainlab AG in Germany and/or the US. • Curve® is a registered trademark of Brainlab AG in Germany and/or the US. • Kick® is a registered trademark of Brainlab AG in Germany and/or the US. • iHelp® is a trademark of Brainlab AG.
Non-Brainlab Trademarks Smith & Nephew, Smith+Nephew and the logo are registered trademarks of Smith+Nephew plc.
Patent Information This product may be covered by one or more patents or pending patent applications. For details, see: www.brainlab.com/patent.
CE Label The CE label indicates that the Brainlab product complies with the essential requirements of Council Directive 93/42/EEC (the “MDD”). HIP7 is a Class IIa product according to the rules established by the MDD.
Disposal Instructions When a surgical instrument reaches the end of its functional life, clean the instrument of all biomaterial/biohazards and safely dispose of the instrument in accordance with applicable laws and regulations. Only dispose of electrical and electronic equipment in accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive or relevant substances that could be present in the medical equipment, visit: www.brainlab.com/sustainability
Report Incidents Related to This Product You are required to report any serious incident that may have occurred related to this product to Brainlab, and if within Europe, to your corresponding national competent authority for medical devices.
Sales in US US federal law restricts this device to sale by or on the order of a physician.
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Symbols
1.3
Symbols
Warnings Warning Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with device use or misuse.
Cautions Cautions are indicated by circular caution symbols. They contain important information regarding potential device malfunctions, device failure, damage to device or damage to property.
Notes NOTE: Notes are formatted in italic type and indicate additional useful hints.
Symbols on Hardware Components The below symbols may be found on the system. Symbol
Explanation Caution NOTE: User should consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Do not re-use NOTE: Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Non-sterile NOTE: Indicates a medical device that has not been subjected to a sterilization process. Do not resterilize NOTE: Indicates a medical device that should not be resterilized. Sterilized with ethylene oxide
Do not use if packaging is damaged
Keep away from sunlight
Keep dry
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GENERAL INFORMATION
Symbol
Explanation Temperature limit NOTE: Indicates the temperature limits to which the medical device can be safely exposed. Humidity limitation NOTE: Indicates the range of humidity to which the medical device can be safely exposed. Atmospheric pressure limitation NOTE: Indicates the range of atmospheric pressure to which the medical device can be safely exposed. Quantity of included items
Manufacturer's batch code Manufacturer's serial number Reference (article) number NOTE: Indicates Brainlab's product number.
Use by date NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
Date of manufacture NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
Manufacturer
Authorized representative in the European Community
IPXX
Ingress Protection Rating • Protection against foreign solids (numbers 0 to 6, or letter X). • Protection against foreign liquids (numbers 0 to 9, or letter X). NOTE: The letter X is listed if insufficient data has been gathered to assign a protection level.
Consult instructions for use U.S. federal law restricts this device to sale by or on order of a physician Contains or presence of natural rubber latex NOTE: Presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.
Non-pyrogenic
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Symbols
Symbol
Explanation
Indicates that the equipment is suitable for direct current only
Contains an RF transmitter for operation
Class II Equipment
Unique Device Identifier
Refer to instruction manual or booklet
Medical Device
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GENERAL INFORMATION
1.4
Using the System
Intended Purpose This Instrument User Guide is intended for use with Brainlab Hip software and contains information on how to assemble and safely use the required instruments in surgery. HIP7 is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient’s preoperative image data being processed by Brainlab IGS platforms, or on an individual 3D-model of the patient’s bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT, X-ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: • Total Joint Replacement • Minimally invasive orthopedic surgery
Place of Use The application shall be used in an operating room/suite. Specific environmental conditions during operation, storage or transport are defined either within this guide or in the respective platform user documentation.
Careful Handling of Hardware System components and accessory instrumentation are comprised of precise mechanical parts. Handle them carefully.
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Training and Documentation
1.5
Training and Documentation
Training Before using the system, all users must participate in a mandatory training program held by a Smith+Nephew authorized representative to ensure safe and appropriate use.
Supervised Support Before using the system for surgical procedures where computer-aided navigation is considered critical, perform a sufficient number of complete procedures together with a Smith+Nephew representative.
Responsibility Warning This system solely provides assistance to the surgeon and does not substitute or replace the surgeon's experience and/or responsibility during its use. It must always be possible for the user to proceed without the assistance of the system. Only trained medical personnel may operate system components and accessory instrumentation.
Reading User Guides This guide describes complex medical software or medical devices that must be used with care. It is therefore important that all users of the system, instrument or software: • Read this guide carefully before handling the equipment • Have access to this guide at all times
Available User Guides NOTE: Available user guides vary depending upon the Brainlab product. If you have questions regarding the user guides you received, please contact Smith+Nephew support.
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User Guide
Contents
Software User Guides
• Overview of treatment planning and image-guided navigation • Description of OR system setup • Detailed software instructions
Hardware User Guides
Detailed information on radiotherapy and surgical hardware, typically defined as large complex instruments
Instrument User Guides
Detailed instructions on instrument handling
Cleaning, Disinfection and Sterilization Guide
Details on cleaning, disinfecting and sterilizing instruments
System User Guide
Detailed information on system setup
Technical User Guide
Detailed technical information on the system, including specifications and compliances
System and Technical User Guide
Combines the contents of the System User Guide and the Technical User Guide.
Instrument User Guide Rev. 1.3 Hip
INSTRUMENTATION OVERVIEW
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INSTRUMENTATION OVERVIEW
2.1
Instrument Handling
Correct Handling Warning The instruments described in this user guide are highly accurate and sensitive medical devices and must be handled with extreme care. If you drop or otherwise damage an instrument, contact Smith+Nephew immediately for advice on how to proceed. Failure to do so may lead to serious injury to the patient. Warning Do not use damaged or corroded instruments. Warning Plan the OR setup prior to surgery. The camera must have an unobstructed view of all marker spheres, otherwise registration and navigation inaccuracies may occur.
Sterilization Warning Unless otherwise indicated, instruments must be sterilized before use. Details are provided in the Cleaning, Disinfection and Sterilization Guide. Warning If a sterile instrument is inadvertently removed from the sterile field, it must be sterilized again.
MR Safety Unless otherwise noted, the instruments are MR unsafe.
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Using Fixation Pins
2.1.1
Using Fixation Pins
General Information The placement of a fixation pin in bone structures is a standard minimally-invasive and low-risk surgical procedure that is required in order to provide a stable basis for attaching reference arrays and performing navigation. However, as an incision is required, please read the following information carefully before continuing.
Risks Warning Because placement of a fixation pin requires an incision, one or more of the following complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, bone fracture or thrombosis. Placement of a fixation pin in the acetabulum may also cause lesions of the viscera.
Precautions Warning In some cases, fixation pins may be placed using an automatic drill, however, use only the lowest drilling speed to maintain maximum control over the drilling depth. Warning Use only a threaded fixation pin with the specified diameter. Using a fixation pin with the incorrect diameter could result in unstable attachment. Warning To ensure stable attachment, the fixation pin should be positioned bicortically where possible.
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INSTRUMENTATION OVERVIEW
2.1.2
Available Instruments
General Instrumentation Illustration
Name
Disposable Reflective Marker Spheres
Disposable Schanz Screws Disposable Sterile Touchpen NOTE: Not detailed in this user guide. See separate instructional leaflet for further information.
Pin Driver Adapter for AO Coupling
Pointers Illustration
Name
Pointer Extended for Hip
Disposable Clip-on Remote Control
Footswitch Illustration
Name
Footswitch (USB)
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Available Instruments
Caliper for Pelvis Illustration
Name
Caliper for Pelvis
Reference Arrays/Bone Fixators, X-Press Illustration
Name
Reference Array T-Geometry X-Press
Bone Fixator 1-Pin X-Press, Size-S/M/L
Wrench For Spine Clamps and Bone Fixator 1-PinXpress
Bone Fixator 2-Pin, Flip-Flop, X-Press
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INSTRUMENTATION OVERVIEW
Reference Array - Femur Illustration
Name
Reference Array Pinless Femur
Disposable Bone Screws 3.5 mm / 14 mm
Hex Screwdriver 2.5 mm with Holding Sleeve
Tap Drill 2.5 mm with AO-Interface Fit
Instrument Adapter Illustration
Name
Reference Array StarLock for Cup Impactor Universal
Cup Impactors Illustration
Name
Cup Impactor Universal Straight
Cup Impactor Universal Offset
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Available Instruments
Illustration
Name
Insert for Cup Impactor Universal
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GENERAL INSTRUMENTATION
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GENERAL INSTRUMENTATION
3.1
Disposable Reflective Marker Spheres
About Disposable Reflective Marker Spheres
Figure 1
Product
Pieces
Article No.
Available from
Disposable Reflective Marker Spheres
90 (30 x 3)
41773
Brainlab and NDI
Disposable Reflective Marker Spheres are attached to reference arrays and instruments, thus enabling the system to detect the position of the patient and instruments in the surgical field. Warning Brainlab navigation systems can only be used with the above marker spheres. The use of other marker spheres could affect navigation accuracy, posing a risk to the patient.
When to Attach Marker Spheres Attach marker spheres to instruments and arrays before calibration or use in surgery.
Ensuring Sterility Marker spheres are delivered sterile. They cannot be resterilized and must be disposed of after use. Warning Do not resterilize disposable reflective marker spheres as this reduces their accuracy, posing a risk to the patient. The reflective marker spheres are single use only.
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Using Marker Spheres
3.1.1
Using Marker Spheres
Ensuring Navigation Accuracy Navigation accuracy critically depends on the condition of the marker spheres used. Warning Verify prior to use that the reflective surface of all marker spheres is in good condition, and not peeling. Warning Only use clean and dry marker spheres. Wet or soiled marker spheres must either be cleaned and dried before further use, or replaced. Warning Do not use defective or deformed marker spheres as this negatively affects navigation, potentially harming the patient. Warning Set up the OR prior to surgery to ensure the camera has an unobstructed view of all marker spheres on the instrument adapters and reference arrays. Do not mask or cover any marker spheres, otherwise navigation is not possible or may be inaccurate.
How to Attach Marker Spheres
Figure 2
Step Tightly screw a marker sphere by hand onto each attachment pin of the instrument.
Ensuring Secure Attachment Warning Ensure that marker spheres can be screwed onto the pin until there is no gap between the sphere and the base of the pin. Do not use a marker sphere if it is not securely attached in this position. Warning If excessive force is needed to screw a marker sphere onto its pin, dispose of the marker sphere and use a new one.
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GENERAL INSTRUMENTATION
Warning If you use marker spheres on, or in the vicinity of, oscillating or vibrating instruments, check the marker spheres at regular intervals to ensure that they remain securely attached.
Cleaning Marker Spheres Warning Only use a soft cloth moistened with sterile water to clean the surface of soiled marker spheres. Ensure that the cleaned marker sphere is absolutely dry before use. Warning If you clean or replace a marker sphere on an instrument or reference array, verify navigation accuracy before continuing.
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