stryker REF 8000-050-005 Suction Tube Frazier Electromagnetic Instruction Manual

stryker REF 8000-050-005 Suction Tube Frazier Electromagnetic

Product Information

Specifications

• Product Name: Suction Tube Frazier Electromagnetic
• Reference Number: 8000-050-005
• Manufacturer: Stryker
• Date of Manufacture: AD 2022-05-31
• Catalog Number: 8000-050-005
• Serial Number: (not specified)
• Sterility: Non-Sterile
• Storage Conditions:
  • Keep away from sunlight
  • Keep dry
  • Temperature limit: (not specified)
  • Humidity limitation: (not specified)
  • Atmospheric pressure limitation: (not specified)
• Contains hazardous substances: No

Product Usage Instructions

How to Use this Document
This document supplements or clarifies information regarding the Suction Tube Frazier Electromagnetic.

General Warning Sign

• Symbol: W001 M002
• Name: General warning sign
• Definition: Signifies a general warning.

Manufacturer Information

• Symbol/Number: 5.1.1
• Name: Manufacturer
• Definition: Indicates the medical device manufacturer as defined in the European Union harmonization legislation.

Date of Manufacture

• Symbol/Number: 5.1.3
• Name: Date of manufacture
• Definition: Indicates the date when the medical device was manufactured.

Batch Code

• Symbol/Number: 5.1.5
• Name: Batch code
• Definition: Indicates the manufacturer’s batch code so that the batch or lot can be identified.

Catalog Number

• Symbol/Number: 5.1.6
• Name: Catalog number
• Definition: Indicates the manufacturer’s catalog number so that the medical device can be identified.

Serial Number

• Symbol/Number: 5.1.7
• Name: Serial number
• Definition: Indicates the manufacturer’s serial number so that the medical device can be identified.

Sterility

• Symbol/Number: 5.2.7
• Name: Non-Sterile
• Definition: Indicates a medical device that has not been subjected to a sterilization process.

Storage Conditions

• Symbol/Number: 5.3.2, 5.3.4, 5.3.7, 5.3.8, 5.3.9
• Name: Keep away from sunlight, Keep dry, Temperature limit, Humidity limitation
• Definition: Indicates the storage conditions for the medical device, including protection from sunlight and moisture.

Consult Instructions for Use

• Symbol/Number: 5.4.3
• Name: Consult instructions for use
• Definition: Indicates the need for the user to consult the instructions for use.

Contains Hazardous Substances

• Symbol/Number: 5.4.10
• Name: Contains hazardous substances
• Definition: Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties.

FAQ

• Q: Is the Suction Tube Frazier Electromagnetic sterile?
  A: No, the suction tube is non-sterile.

• Q: What are the storage conditions for the suction tube?
  A: The suction tube should be kept away from sunlight and moisture.

How to Use 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 user manual of these devices is 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 or medical staff injury.
• The signal word CAUTION highlights a product reliability issue. Comply with this information to prevent product damage.
• Supplements or clarifies information.

Symbol Definition
EN ISO 7010 Graphical symbols – Safety colors 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

IEC 60417 Graphical symbols for use on equipment

Product-Specific Symbols

81 FR 38911 FDA Final rule for the use of symbols in labeling

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

Regulatory marks and logos

Safety Information

WARNING

• The product is delivered in a non-sterile condition. Before first use, as well as before each following use, the product must be processed according to a validated procedure.
• 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).
• 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.
• Do not use the system during the discharge of a defibrillator. All navigated instruments must be removed from the patient and the operating area beforehand.
• 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 by 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.

Intended Use

EU
Suction Tube Frazier Electromagnetic and Suction Tube Eicken Electromagnetic are accessories to the Electromagnetic Navigation Unit and are intended for locating anatomical structures and removing fluids and tissue within ENT procedures.

1. Outside the EU
   Suction Tube Frazier Electromagnetic and Suction Tube Eicken Electromagnetic are accessories to the Electromagnetic Navigation Unit and are intended for pointing at anatomical structures.

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.

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.

Product Overview

• A. Suction Tube Frazier Electromagnetic
• B. Suction Tube Eicken Electromagnetic
• C. Polymer tubing
• D. Sensor tube

Navigation Point
Each navigated instrument has a navigation point. The navigation point is the position that is tracked by the navigation system. The navigation point of the Suction Tube Electromagnetic is visualized in Figure 2.

• A. Sensor tube
• B. Navigation point
• C. Tip of the suction tube

Product specifications

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.

Instructions for Application

WARNING

• 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.
• Make sure that instruments are not damaged by third party products. Drills and shavers may damage the polymer tubing.
• Make sure that the polymer tubing is undamaged. If any contamination is detected under the polymer tubing, the product must not be used.

When using the product in combination with suction devices, adhere to the following warnings:

WARNING

• Carefully determine the amount of negative pressure that is applied to the patient. Use only the minimum amount of negative pressure necessary to accomplish the suctioning procedure. Failure to comply may result in tissue damage.
• Check the negative pressure of the vacuum unit before using the suction tubes. Check all connections for any leakages. Too low negative pressure may lead to insufficient suction flow.
• Do not apply the suction tip too close to blood vessels or vital organs; contact with vital organs or blood vessels may result in serious patient injury.

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

Reprocessing
For reprocessing instructions, safety directives, and reprocessing equipment, refer to the Stryker ENT Navigation System Reprocessing Instructions (TD8000010706).

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. Sharp or pointed components need to be sent back in a protected state.

Disposal

Risk of injury or infection can be avoided by safe disposal of the product components. Sharp and pointed components need to be collected and locked in a tight and break-proof container. 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.

• 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) electronic products should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated before recycling.

Technical Specifications

Materials

• This device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports the position that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.
• The plug used in the electronic products contains the following substance: Lead, CAS No. 7439-92-1 (1907/2006 REACH). No specific precautions are required for handling items manufactured from alloys containing lead in the supplied condition.
• The silicone glue used in this product contains the following substances: Decamethylcyclopentasiloxane, CAS No. 541-02-6 and Dodecamethylcyclohexasiloxane, CAS No. 540-97-6 (1907/2006 REACH).

Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
79111 Freiburg (Germany)
t: +49 761 4512 0 (Germany)
t: +1 269 323 7700 (USA)
U.S. Patents: www.stryker.com/patents
Copyright © 2022 Stryker

References

• International homepage | Stryker
• Patents | Stryker

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