stryker REF 8000-100-001 Patient Tracker Tabs Instruction Manual

stryker REF 8000-100-001 Patient Tracker Tabs Instruction Manual

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 instructions for use supplied with the respective software application before using the product or any component compatible with the product. When combined with other medical devices, the instructions for 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/or healthcare staff injury.

The signal word CAUTION highlights a product reliability issue. Comply with this information to prevent product damage.

Supplements or clarifies information.

I SO 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1 General Requirements
Symbol/ Number| Name: Definition
5.1.1| Date of manufacture: Indicates the date when the medical device was manufactured.

5.1.3| Use-by date: Indicates the date after which the medical device is not to be used

5.1.5| Batch code: Indicates the manufacturer’s batch code so that the batch or lot can be identified.

REF 5.1.6| Catalog number: Indicates the manufacturer’s catalog number so that the medical device can be identified.

5.2.7| Non-Sterile: Indicates a medical device that has not been subjected to a sterilization process.

5.3.2| Keep away from sunlight: Indicates a medical device that needs protection from light sources.

5.3.4| Keep dry: Indicates a medical device that needs to be protected from moisture.

5.3.7| Temperature limit: Indicates the temperature limits to which the medical device can be safely exposed.

5.4.2| Do not re-use: Indicates a medical device that is intended for one use or for use on a single patient during a single procedure.

5.4.3| Consult instructions for use: Indicates the need to consult the instructions for use.

5.7.7| Medical device: Indicates the item is a medical device.
| Quantity: Indicates the number of medical devices in the packaging.
| Note: Used to supplement or clarify information.
81 FR 38911 FDA Final rule for the use of symbols in labeling
Symbol| Name: Definition
Rx Only| Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Regulatory marks and logos
Symbol| Definition
| Indicates that a device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation providing for its affixing.

Safety Information

WARNING

• Unauthorized modifications of the product are forbidden for safety reasons. –
• The product is only for single-use and must not be reused.
• The product is not sterile.
• 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 are detected.
• 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 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 Tabs are an accessory to the Electromagnetic Navigation Unit and are intended for fixation of the Patient Tracker Electromagnetic to intact skin.

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 antrostomies, ethmoidectomies,
  sphenoidotomies/ sphenoid explorations, turbinate resections, and frontal sinusotomies

• ENT-related anterior skull base procedures.

Contraindications

None known.
Note: 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.

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

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.

For Use With

WARNING
Use only Stryker-approved products, unless otherwise specified.

For information related to compatible software applications, refer to the instructions for use supplied with the respective software application. For information related to product specific compatibility, refer to the table below.

Description

Instructions for Application

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 surgical procedures with Cranial Guidance Software application:

WARNING
To avoid the risk of Medical Adhesive Related Skin Injuries (MARSI), consider using
alternative adhesives for patients with fragile skin, e.g. pediatric patients. Refer to the
user manual of the Cranial Guidance Software for more information on appropriate
adhesives.

Disposal

Risk of injury or infection can be avoided by 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.

Technical Specifications

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