stryker 8000-040-002 ENT Navigation System Instruction Manual

stryker 8000-040-002 ENT Navigation System

Specifications

• Product Name : Patient Tracker Electromagnetic -10 uses
• Model Number: 8000-040-002
• Version: TD8000040701 Rev AF
• Release Date: 2024-01-15

Product Information

This manual is the most comprehensive source of information for the safe, effective, and compliant use and/or maintenance of the product. Read and understand this manual as well as the respective system user manual before using the product or any component compatible with the product. When combined with other medical devices, the instructions for the use of these devices are to be considered as well. This manual is a permanent part of the product. Keep this manual for future reference.

Conventions Used in this Document:

• WARNING: Highlights a safety-related issue. Comply with this information to prevent patient and medical staff injury.
• CAUTION: Highlights a product reliability issue. Comply with this information to prevent product damage.
• Manufacturer: Indicates the medical device manufacturer.

How to Use this Document

About this Document
This manual is the most comprehensive source of information for the safe, effective, and compliant use and/or maintenance of the product. Read and understand this manual as well as the respective system user manual before using the product or any component compatible with the product. When combined with other medical devices, the instructions for the use of these devices are to be considered as well. This manual is a permanent part of the product. Keep this manual for future reference.

• The following conventions are used in this document:
• The signal word WARNING highlights a safety-related issue. Comply with this information to prevent patient and medical staff injury.
• The signal word CAUTION highlights a product reliability issue. Comply with this information to prevent product damage.

INFO: Supplements or clarifies information.

Symbol Definitions
EN ISO 7010: Graphical symbols – Safety colours and safety signs – Registered safety signs

ISO 15223-1: Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Product‑specific symbols

IEC 60417: Graphical symbols for use on equipment

ASTM F2503: Standard practice for marking medical devices and other items for safety in the MR environment

21 CFR 801.109

Directive 2012/19/EU on waste electrical and electronic equipment (WEEE)

Regulatory marks and logos

Safety Information

WARNING

• The product is delivered non‑sterile. Before the first use, as well as before each following use, the product must be processed according to a validated procedure.
• Before using a medical product, assure yourself of its functional safety and proper condition via a visual inspection. Do not use the product if any defects, such as breaks, cracks, deformations or wear, are detected. Particularly important parts such as tips, notches and all moveable components should be checked with extra care.
• Unauthorized modifications of the product are forbidden for safety reasons.
• Due to its composition, the product is not to be used together with other magnetically sensitive medical products, devices or instruments.(e.g. MRI)
• Do not use the device in the environment of a magnetic resonance imaging (MRI) scanner
• The product is a high-precision instrument. Avoid subjecting it to serious strains, such as heavy impacts. The product cannot be used if there are visible defects. After a heavy impact, the product must be checked for defects.
• 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.

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

Product Information

WARNING

• The product may only be used for its intended purpose and in accordance with this document and all current versions of relevant system and software application documentation.
• This document is part of the product and must be accessible to personnel at all times. It must be provided to subsequent owners or users.

Stryker ENT Navigation System

**United States / Rest of World***

Intended Use
The Patient Tracker Electromagnetic – 10 Uses is an accessory to the Electromagnetic Navigation Unit and is intended for locating the patient.

Indications for Use
The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT‑ or MR‑based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

• Transsphenoidal access procedures:
• Intranasal procedures
• Sinus procedures, such as maxillary antrostomy, ethmoidectomies, sphenoidotomies/ sphenoid explorations, turbinate resections, and frontal sinusotomies
• ENT-related anterior skull base procedures

Contraindications
None known.

Cranial Guidance System

**United States and Canada***

• Refer to the user manual supplied with the Cranial Guidance Software
• (REF 6000‑670‑000) for system indications and contraindications.

**Rest of World***
The Patient Tracker Electromagnetic – 10 Uses is indicated for use as an accessory with adult and pediatric patients when using the Cranial Guidance Software using electromagnetic navigation. It is intended to be used as a patient tracker with electromagnetic navigation.

The system is indicated as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures where the use of stereotactic surgery may be appropriate. The system can be used for intraoperative guidance where reference to a rigid anatomical structure, such as the skull, can be identified.

Contraindications
None known.
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.

User Group
Healthcare professionals (surgeon/resident, nurse/professional caregiver) are 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.

Product Overview

Figure 1: Patient Tracker Electromagnetic-10 uses

Instructions for Application
The patient tracker provides a reference for the patient during surgery. For this purpose, the tracker is securely fixed onto the patient with appropriate accessories as near as possible to the operation area.

WARNING: Before and during the surgical procedure, regularly verify that the patient tracker is firmly attached to the patient. The patient tracker must not move concerning the patient. If the patient tracker moves, the system displays inaccurate positional information on the instruments. If you suspect that the patient tracker has moved, check landmarks to verify navigation accuracy.

For instructions on how to use the product for a surgical procedure, refer to the instructions for use supplied with the respective software application.

For Use With

WARNING: Use only Stryker‑approved products, unless otherwise specified.
For information related to compatible software applications, refer to the user manual supplied with the respective software application. For information related to product-specific compatibility, refer to the table below.

Description/REF

• Patient Tracker Tabs: 8000-100-001
  

Disassembly

1. Carefully remove the patient tracker from the patient skin.
2. Remove the Patient Tracker Tab from the patient tracker, and dispose of the Patient Tracker Tab.

Product Lifetime
The instrument is validated for ten reprocessing cycles. Thus, the instrument contains a usage counter that disables the instrument after running the tenth usage cycle in surgery. The usage counter is updated as soon as the instrument is connected during surgery and is shown in the software.

To maintain an accurate use count, connect the instrument to the electromagnetic port at least once during surgery. This also applies to replacement instruments if they have been taken from sterile packaging.

Reprocessing

If you use the dedicated EM Instruments Insert Tray REF 8000‑820‑000* for cleaning, disinfection and sterilization, refer to the Guide for Cleaning, Disinfection and Steam-Based Sterilization (TD6000005750) for reprocessing instructions, safety directives, and reprocessing equipment. The Patient Tracker Electromagnetic– 10 uses is designed for machine cleaning and disinfection like instruments without electronics. The cleaning group of the Patient Tracker Electromagnetic– 10 uses is: V.
If you use sterilization pouches for sterilization, refer to the Stryker ENT Navigation System Reprocessing Instructions (TD8000010706) for reprocessing instructions, safety directives, and reprocessing equipment.

Maintenance

Maintenance and repair may only be conducted by the manufacturer or authorized partners. The product components may only be sent back to the manufacturer in a cleaned, disinfected, and sterilized condition.

Disposal

The risk of injury or infection can be avoided by the safe disposal of the product components. They must be stored in such a way that they are protected from unauthorized use. Contaminated products are to be supplied to a hazardous waste site and handled in a way that contamination of third parties is excluded.

INFO:

• After using the electromagnetic system, make sure that instruments that cannot be reprocessed again are disposed of.
• By European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) products should be collected separately for recycling. Do not dispose of unsorted municipal waste. Contact the local distributor for disposal information. Ensure infected equipment is decontaminated before recycling.
• The plugs used in the electronic products contain the following substance: Lead, CAS No. 7439‑92‑1 (1907/2006 REACH). Handling Instructions: No specific precautions are required for handling items manufactured from alloys containing lead in the supplied condition.
• The silicone glue used in the products contains the following substances: Decamethylcyclopentasiloxane, CAS No. 541‑02‑6 and Dodecamethylcyclohexasiloxane, CAS No. 540‑97‑6 (1907/2006 REACH).

Technical Specifications

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

U.S. Patents: www.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)

Frequently Asked Questions

• 1. What is the model number of the product?
  • The model number of the product is 8000-040-002.
• 2. What should I do if I encounter a WARNING signal while using the product?
  • If you encounter a WARNING signal, immediately follow the safety instructions provided to prevent any harm to patients or medical staff.

References

• Patents | Stryker

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