stryker 6000-801-000 Precision Targeting System Instruction Manual

stryker 6000-801-000 Precision Targeting System

Product Information

Specifications

• Product Name: Precision Targeting System
• Model Numbers: REF 6000-801-000, REF 6000-802-000, REF 6000-803-000, REF 6000-804-032, REF 6000-805-021, REF 6000-804-060, REF 6000-806-000
• Regulatory Classification: Rx Only

Product Overview
The Precision Targeting System is designed to provide accurate and precise targeting for medical procedures. It includes components such as trackers, instruments, calibration devices, and adapters to facilitate its use.

Usage Instructions

• Introduction
  Read the user manual carefully before using the Precision Targeting System. Familiarize yourself with the components of the guidance system and pay special attention to safety information.

• For Use With
  The Precision Targeting System is intended for use by healthcare providers who are responsible for determining the appropriateness of using the product and the specific technique for each patient.

• Reprocessing
  Follow the provided instructions for disassembly and reprocessing of the Precision Targeting System components after each use to maintain cleanliness and sterility.

• Disposal, Transport, and Storage
  Dispose of the system components according to local regulations. During transport, ensure the system is secured properly. Store the system in a clean and dry environment.

• Technical Specifications
  Refer to the technical specifications section in the user manual for detailed information on the system’s capabilities, dimensions, and operational requirements.

Introduction

About this document
This document is the most comprehensive source of information for the safe and effective use of the product. Read this document carefully. Familiarization with the user documentation for the components of the guidance system before use is important. Pay special attention to safety information. Keep this document accessible to users. The healthcare provider performing any procedure is responsible for determining the appropriateness of using the product and for the specific technique for each patient. Stryker, as a manufacturer, does not recommend a specific surgical procedure.

The following conventions are used in this document:

• The signal word WARNING indicates a hazardous situation that, if not avoided, could result in death or serious injury.
• The signal word CAUTION indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.
• The signal word NOTICE indicates information considered important, but not hazard-related, e.g. messages relating to property damage.

Other applicable documents
In addition to this document, the following documents are provided:

• Guide for cleaning and steam-based sterilization
• User manual provided electronically with each Stryker application

Definition of terms and abbreviations
The following table provides definitions of terms and abbreviations used in this document

intended use, facilitate its use or enable its functions. For example: Trackers, instruments, calibra- tion devices, adapters, etc. Refer to the user manual for a list of accessories.
Guidance system| The computer and navigation camera system on which the surgical software applications run.
Tracker| Instrument that is used by the system to track the posi- tion of a patient, an instrument or a C-arm fluoroscope. The position is used to compute navigational informa- tion, which is then displayed on the navigation screen.

Safety information

Safety directives

  WARNING|
---|---
Before use| •      Before each use, check the product for loose compo- nents, damage, malfunction, and bent or deformed parts. Do not use if these conditions exist. Failure to comply may lead to patient or medical staff injury. If service is required, contact your Stryker sales representative.
| •      Prior to surgery, the instrument should be checked with the guidance system to ensure they are functioning properly.
Modifications| •      Do not modify this equipment without authorization of the manufacturer.
General Information| •      Read and understand this information, file it in your maintenance records. Familiarization with the guidance system before its use is important. Refer to the instruc- tions for use of the guidance system. Only trained personnel are to use this system.
| •      The instrument must only be used in accordance with the instructions for use contained in this manual by authorized persons who have been fully trained in their safe and effective use. The failure to follow these instructions will void your warranty.
| •      If the color coating on the Linear Adjustment knobs, Rotational Adjustment knobs and Locking knobs are found to be partially or fully chipped off, contact your Stryker sales representative immediately.
| •      The health care provider performing any procedure is responsible for determining the appropriateness of the instrument and the specific technique for each patient. Stryker, as a manufacturer, does not recommend a specific surgical procedure.
•      Performing procedures with instruments other than those specified in these instructions or outside of their intended use will compromise the navigation accuracy.

•      Use only Stryker approved components and accessories, unless otherwise specified. Do not modify any compo- nent or accessory. Failure to comply may result in patient and/or healthcare staff injury.
•      After assembly, check that all components fit properly and securely into each other.
•      Avoid subjecting the product to serious strains, such as heavy impacts. After a heavy impact, the product must be checked for defects. The product cannot be used if there are visible defects.
•      ALWAYS use a sterile drape to separate a sterile device from a non- sterile zone.
•      ALWAYS use a correct and rigidly installed patient tracker or table interfaces like a skull clamp.
•      In case of known pre-existing conditions of variants of Creutzfeldt- Jakob-Disease (CJD) of the patient, ALWAYS ensure that the product is quarantined and not being used further. ALWAYS follow the recommendation of the national authorities (eg. WHO, RKI or CDC) concerning Creutzfeldt-Jakob- Disease.
•      Do not expose the product to a high magnetic field such as from a magnetic resonance imaging (MRI) device.
  CAUTION
•      Prior to surgery, ALWAYS ensure that all required components are available for the procedure.
•      ALWAYS handle the equipment with care. DO NOT drop the device.

The user and/or patient should report any serious product-related incident to both the manufacturer and the national competent authority of where the user and/or patient is established.

User group
Healthcare professionals (surgeon/resident, nurse/professional caregiver) educated in computer-assisted surgery and thoroughly familiar with the instructions for use and with the operation of this product. To request an additional in-service instruction, contact Stryker.

Indications for use

• **United States and Canada***
  Refer to the user manual supplied with the Cranial Guidance Software for system indications and contraindications.

• **Rest of World***
  The Precision Targeting System is indicated for use as an accessory to the Cranial Guidance Software. It is intended to be used to provide guidance during drilling and biopsy of cranial tissue. The system is indicated as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which the use of computer-assisted surgery may be appropriate and where reference to a rigid anatomical structure can be identified.

Note : The product may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Contact your Stryker representative for product availability.

Contraindications
None known.

Product Overview

Part

A| Precision Targeting Arm (6000-801-000)
A.1| Quick connect push button
A.2| Central locking knob
A.3| Starburst knob
B| Precision Targeting Guide (6000-802-000)
B.1| Precision Targeting Guide push button
B.2| Rotational adjustment knob for precise angular adjustment
B.3| Linear adjustment knob for precise linear adjustment
B.4| Locking knob for locking the trajectory
C| Tracker Sleeve (6000-803-000)
C.1| Tracker Sleeve push button
C.2| Tracker Sleeve Body (6000-803-010)
C.3| Validation Tip (6000-803-020)
D| Arm Connector Component (6000-806- 000)
D.1| Starburst knob
E| Twist Drill Sleeve (6000-804-032)
E.1| Twist Drill Sleeve Body (6000-804-130)
E.2| Twist Drill Depth Stopper (6000-804-230)
F| Elite Drill Sleeve (6000-804-060)
F.1| Elite Drill Sleeve Body (6000-804-160)
F.2| Elite Drill Depth Stopper (6000-804-260)
G| Needle Sleeve (6000-805-021)

Preparation for use
Arrow alignment of the Precision Targeting Guide

Prior to setting up the Precision Targeting System adjust the knobs so that the marked arrows in Figures 2 and 3 match.

1. Set all locking knobs to open.
2. Locate the adjusting knobs.
3. Adjust the linear adjustment knobs so that the marked arrows in Figure 2 match. The nominal position of the arm is achieved by aligning the arrow heads.
4. Adjust the rotational adjustment knobs so that the marked arrows in Figure 3 match. The nominal position of the arm is achieved by aligning the arrow heads.

Preparing the Tracker Sleeve

1. Prepare the Tracker Sleeve by attaching the 4 Navigation Spheres to the tracker post.

Validating the Tracker Sleeve
For instructions on how to use the Validation Tip for the validation of the Tracker Sleeve in conjunction with the software application, refer to the user manual supplied with the software application.

1. Press the push button of the Tracker Sleeve (a).

2. Insert the Validation Tip into the Tracker Sleeve (b).
   The Validation Tip needs to be fully inserted into the Tracker Sleeve.

3. Place the Validation Tip in the Calibration Body’s cone. Ensure the Validation Tip touches the bottom of the cone.

Preparing the Precision Targeting System

WARNING
MAINTAIN SYSTEM STABILITY
ALWAYS ensure proper assembly of the quick connect feature by listening for the audible latching of the locking mechanism.

CAUTION
ALWAYS be careful while attaching the Precision Targeting Guide to the Precision Targeting Arm and while attaching the Tracker Sleeve to the Precision Targeting Guide to avoid a pinch point.

ALWAYS ensure that the drape is not caught between the starburst connection of the skull clamp, Arm Connector Component and Precision Targeting Arm during assembly.

1. Attach the Arm Connector Component to the skull clamp.
2. Tighten the starburst knob of the Arm Connector Component.
3. Attach the Precision Targeting Arm directly to the skull clamp or by attaching it to the Arm Connector Component.
4. Tighten the starburst knob of the Precision Targeting Arm. The right side of the Arm Connector Component is the preferred location for better maneuverability of Precision Targeting Arm.
5. Lock the central knob of the Precision Targeting Arm.
   • If the central knob has been fully loosened it may require a little force to be turned in the clockwise direction.
   • The other starburst of the Arm Connector Component may be used for attaching other ancillary components such as image-guided surgery accessories.
6. Attach the Precision Targeting Guide to the Precision Targeting Arm by pushing the quick connect button.

Intraoperative use

WARNING
MAINTAIN SYSTEM STABILITY
Do not press the quick connect button until required. It will disengage the Precision Targeting Guide from the Precision Targeting Arm.

For understanding the interaction between the Precision Targeting System and the software application, refer to the user manual supplied with the application.

Inserting the Tracker Sleeve
WARNING
MAINTAIN ACCURACY
ALWAYS ensure that the Tracker Sleeve is seated completely onto the Precision

Targeting Guide before proceeding.

1. Press the push button (a).
2. Insert the Tracker Sleeve into the Precision Targeting Guide (b).

Arm alignment and Guide Alignment

WARNING
MAINTAIN ACCURATE TRAJECTORY: ALWAYS ensure to lock the locking knob after guide alignment.

CAUTION : ALWAYS carefully handle the device when the Precision Targeting Guide is near to the skull.

The Precision Targeting Guide has a color coding which is used for the
Guide alignment procedure in the software application.
For instructions on how to do the Guide alignment and Arm alignment,
refer to the user manual supplied with the software application.
Locking knob to be hand tighten. Do not use any tool to lock/unlock the locking
knob.

Drilling
WARNING : DRILL DEPTH

• ALWAYS tighten the Drill Depth Stopper knob completely to avoid any slippage.
• ALWAYS attach the Drill Depth Stopper before inserting the drill into the sleeve.

METAL DEBRIS

• ALWAYS ensure the drill is stopped when inserting or before removing it from Drill Sleeve.

FOLLOW PLANNED TRAJECTORY

• ALWAYS ensure that the Drill Sleeve is seated completely onto Tracker Sleeve before proceeding.
• ALWAYS ensure to use the Elite Drill Sleeve for drilling via elite attachment and the Twist Drill Sleeve for drilling via Twist drill.

1. Press the push button (a).
2. Insert the Drill Sleeve into the Tracker Sleeve (b).
3. Attach the Twist Drill Depth Stopper on the Twist Drill according to the drill depth determined by the user. When using the Elite Attachment attach the Elite Drill Depth Stopper accordingly.
4. Tighten the knob of the Drill Depth Stopper.
5. Perform drilling.
6. Press the push button (a).
7. Remove the Drill Sleeve after drilling through the device (b).

Taking a biopsy

WARNING
FOLLOW PLANNED TRAJECTORY

• ALWAYS ensure that the Needle Sleeve is seated completely onto the Tracker Sleeve before proceeding.
• After drilling, ALWAYS ensure that the device comes back to its original trajectory before taking a sample. If not, set the trajectory again.
• ALWAYS ensure to use the Needle Sleeve for taking a biopsy sample.
• DO NOT insert the Biopsy Needle further if the user feels a drag or resistance while inserting the Biopsy Needle.

ALWAYS ensure to tighten the knob of the Needle Sleeve before taking a sample. ALWAYS set the Needle Sleeve in unlock mode before removing the biopsy needle from its sleeve.

1. Gently loosen the knob of the Needle Sleeve (a) by turning it counterclockwise. Do not continue turning the knob after feeling resistance. The unlock state is achieved when the knob feels loose. The further applied force may prevent the Biopsy Needle from passing through the Needle Sleeve.
2. Press the push button (b).
3. Insert the Needle Sleeve into the Tracker Sleeve, which is attached to the Precision Targeting Guide (c).
4. Pass the Biopsy Needle through the Needle Sleeve for biopsy sampling (a).
5. Lock the Needle Sleeve (b) to lock the outer cannula of the Biopsy Needle.
6. Take a biopsy sample.
7. Unlock the Needle Sleeve (b) to remove the Biopsy Needle.
8. Press the push button (c) to remove the Needle Sleeve from the Tracker Sleeve.

Refer to the instructions for use of the Biopsy Needle for instructions on how to use the Biopsy Needle.

Reprocessing

Disassembly for reprocessing

WARNING

• Before disassembly, ALWAYS ensure to remove all components like the Biopsy Needle from within the brain.
• During disassembly, ALWAYS hold the Precision Targeting Guide with one hand before loosening the central knob of the Precision Targeting Arm with the other hand and then move the arm away from the patient.
• Clean and sterilize the instrument before first and every use. Refer to the Guide for Cleaning and Steam-Based Sterilization.

1. Remove the sleeve by pressing the Tracker Sleeve push button.
2. Remove the Tracker Sleeve from the Precision Targeting Guide by pressing the Precision Targeting Guide push button.
3. Remove the Navigation Spheres from the Tracker Sleeve.
4. Remove the Precision Targeting Guide from the Precision Targeting Arm by pressing the quick connect button.
5. Remove the Precision Targeting Arm from the Arm Connector Component by loosening the starburst knob.
6. Remove the Arm Connector Component from the skull clamp.
7. Remove the Drill Depth Stopper from the Twist Drill/Elite attachment by unlocking the Drill Depth Stopper knob.
8. Where appropriate, put all the instruments back into the Precision Targeting System Insert Tray at their designated location.

Reprocessing instructions
This section contains only product-specific information. For general reprocessing instructions, safety notes, and reprocessing equipment, refer to the Guide for Cleaning, Disinfection, and Steam-Based Sterilization (GCDS, TD6000005750). Where instructions between this document and the GCDS differ, follow this document.

The cleaning group of each instrument according to the GCDS is:

Precision Targeting Arm

(refer to special reprocessing instructions in this sec- tion)

| 4
Validation Tip| 1
Arm Connector Component| 4

These instruments can be cleaned and sterilized in the Precision Targeting System Insert Tray (REF 6000-810-000). Refer to the tray IFU for handling of the tray and placement of the instruments.

WARNING
ALWAYS open all four locking knob and all four adjustment knobs of the Precision Targeting Guide such that the lead screws of the linear adjustment knob and threads of the rotational adjustment knobs are in maximum exposed state during reprocessing. Disassemble all components with removable parts during reprocessing.

Reprocessing instructions for the Precision Targeting Arm
Follow the GCDS with the following exceptions: The Precision Targeting Arm can only be cleaned in combination of manual pre-cleaning and machine washing. Manual pre-cleaning only is not sufficient.

1. Manual pre-cleaning of the device:

   • Wet the wipes in the cleaning solution. Dip the wipes into the solution until saturated. After wetting the wipe, the excess liquid should be squeezed out. The wipes should be wet but not dripping.
   • Remove heavy residues from the devices with the wipes.
   • Keep the central knob of Precision Targeting Arm LOOSENED while using wet wipes and clean around articulated parts at least 3 times.
   • TIGHTEN the central knob of the Precision Targeting Arm.
   • Remove all residues with the cleaning tools.
   • Rinse the devices with water whose quality is defined in the GCDS until the device is no longer slippery to the touch. Repeat these steps until the device is visibly clean.

2. Machine cleaning and disinfection of the device:

   • Place the instrument in the Precision Targeting System Insert Tray and continue as instructed in the GCDS Section 4.3 Machine Cleaning and Disinfection with a Washer-Disinfector.
     WARNING

   • ALWAYS ensure that the central knob of the Precision Targeting Arm is TIGHTENED during machine cleaning, disinfection, and when exposed to running water.

   • DO NOT immerse the Precision Targeting Arm in liquids.

3. Sterilization
   WARNING

   • ALWAYS ensure that the central knob of the Precision Targeting Arm is LOOSENED during sterilization

Disposal, transport and storage

1. Disposal
   Products that have been in contact with material of human origin may be infectious. Dispose of with the necessary precautionary measures in accordance with local regulations. Ensure that infected products are decontaminated prior to recycling.

2. Transport

   • WARNING
     ALWAYS transport wrapped equipment with care to prevent damaging the sterile barrier.

3. Storage

   • WARNING
   • ALWAYS store wrapped, processed equipment in a controlled environment that avoids extremes in temperature and moisture. Refer to the Specifications section.
   • Excessive handling of wrapped equipment will increase the likelihood of damaging the sterile barrier and may lead to contamination.
   • CAUTION
     To ensure the longevity, performance and safety of this equipment, use of the original packaging material is recommended when storing or transporting this equipment.

For use with

WARNING
Use only the Stryker-approved products specified in this section.

Refer to the software user manual for a complete list of compatible products on system level.

Description: Catalog number

Technical specifications

Specifications listed are approximate and may vary slightly from unit to unit.

Materials, dimensions, and weight

Precision Targeting Guide
Materials| Stainless steel
Length| 148.850 mm
Width| 149.950 mm
Height| 59.68 mm
Weight| 718.1 g
Precision Targeting Arm
Materials| Stainless steel, aluminum.
Length| 565 mm
Width| 99.7 mm
Height| 80 mm
Weight| 2350 g
Arm Connector Component
Materials| Stainless steel
Length| 159 mm
Width| 62 mm
Height| 60 mm
Weight| 623.4 g
Needle Sleeve|
Materials| Stainless steel
Length| 31.3 mm
Width| 20 mm
Height| 64 mm
Weight| 35.8 g
Elite Drill Sleeve
Materials| Stainless steel
Diameter| 17 mm
Height| 59.6 mm
Weight| 28.1 g
Materials, dimensions, and weight

Elite DDS|
Materials| Stainless steel
Length| 31.3 mm
Width| 20 mm
Height| 10 mm
Weight| 17.7 g
Twist Drill Sleeve
Materials| Stainless steel
Diameter| 17 mm
Height| 59.6 mm
Weight| 37.1 g
Twist DDS|
Materials| Stainless steel
Length| 31.3 mm
Width| 20 mm
Height| 10 mm
Weight| 19.1 g
Tracker Sleeve|
Materials| Stainless steel
Length| 54 mm
Width| 96.5 mm
Height| 73 mm
Weight| 128.3 g
Validation Tip|
Materials| Stainless steel
Diameter| 17 mm
Height| 203 mm
Weight| 67.3 g

Environmental specifications

Definition of symbols

The following table defines the symbols used in this document, on the product, and on the product label.

EN ISO 7010 : Graphical symbols — Safety colors and safety signs — Registered safety signs

Stryker Corporation or its divisions or other affiliated entities own, use, or have applied for the following trademarks or service marks: Stryker, Leibinger, Q Guidance, πdrive. All other trademarks are trademarks of their respective owners or holders.

U.S. Patents: stryker.com/patents

Copyright © 2024 Stryker

Stryker Leibinger GmbH & Co. KG

• Bötzinger Straße 41
• 79111 Freiburg (Germany)
• t: +49 761 4512 0 (Germany)
• t: +1 269 323 7700 (USA)

stryker.com

FAQ

Q: Can the Precision Targeting System be used for all medical procedures?
A: The healthcare provider should determine the appropriateness of using the system for specific procedures.

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