Stryker SERFAS User Manual
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Stryker SERFAS User Manual

Stryker SERFAS User Manual

Endoscopy radio frequency ablation system
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APPROVALS
DATE
DRAW N
A. Infanger
7/21/03
ORIGINATOR
A. Infanger
7/18/03
DOC. CONTROL
W . Hu
7/22/03
REVISIONS
LTR
ECN NO.
F
22464
G
24214
H
25909
TITLE
SIZE DOCUMENT NO.
A
DATE
APPROVED
9/10/02 A. Infanger
12/19/02 A. Infanger
07/21/03 A. Infanger
SERFAS User Manual
1000-400-433
LTR
ECN NO.
5900 Optical Court, San Jose, CA 95138
SHEET
REVISIONS
DATE
APPROVED
OF
1
35

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Summary of Contents for Stryker SERFAS

  • Page 1 5900 Optical Court, San Jose, CA 95138 TITLE APPROVALS DATE DRAW N A. Infanger 7/21/03 SERFAS User Manual ORIGINATOR A. Infanger 7/18/03 DOC. CONTROL W . Hu SIZE DOCUMENT NO. SHEET 7/22/03 1000-400-433 REVISIONS REVISIONS ECN NO. DATE APPROVED ECN NO.
  • Page 2 (Stryker Endoscopy Radio Frequency Ablation System) USER MANUAL...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS INDICATIONS/CONTRAINDICATIONS ..................1 WARNINGS AND CAUTIONS ....................... 2 User and Patient Safety......................2 Operator Qualification ....................... 3 General Warnings and Cautions ....................3 III. PRODUCT DESCRIPTION AND USE ..................4 RF Generator ..........................4 Disposable Probes ........................7 Footswitch ..........................

  • Page 5: Indications/Contraindications

    INDICA TIONS: SERFAS is designed and intended to be used in the resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, elbow, hip, and wrist. This system is intended to be used with conductive irrigants such as, saline or Ringer’s lactate.

  • Page 6: Warnings And Cautions

    Do not use SERFAS on patients with heart pacemakers or other electronic device implants. Doing so could lead ● to electromagnetic interference and possible death. Do not activate SERFAS for prolonged or unnecessary lengths of time when not in contact with tissue. Doing so ● may lead to unintentional damage to surrounding tissue.

  • Page 7: Operator Qualification

    Read this operating manual thoroughly and be familiar with its contents prior to operating the equipment. ● Be sure that the system functions as outlined in this User Manual prior to a surgical procedure. SERFAS was ● fully tested at the factory before shipment.

  • Page 8: Product Description And Use

    PRODUCT DESCRIPTION AND USE SERFAS consists of the RF Generator, Footswitch, Handpiece Cable and Probe. The RF Generator is a radio-frequency energy-generating unit, designed to deliver a high frequency output to perform electrosurgical procedures. Components of SERFAS, the Footswitch, Probe and Handpiece Cable are specifically designed to connect with the RF Generator and are intended to be used together as a single unit.
  • Page 9 REAR PANEL: NOTE: Refer to Appendix B for rear panel labeling definitions. 1. Equipotential Ground Stud – Provides a means of securely linking the earth grounds of SERFAS to other grounded equipment. 2. RS-232 Port – For manufacturing and test purposes only.
  • Page 10 PRODUCT DESCRIPTION AND USE Synthesized Voice Feature: When the Synthesized Voice feature of SERFAS is enabled, the user has the option for receiving voice feedback for actions. The following commands will be issued in the selected language: ACTION MESSAGE Probe Connection “Level 1 …...

  • Page 11: Disposable Probes

    PRODUCT DESCRIPTION AND USE DISPOSABLE PROBES DISPOSABLE PROBES DISPOSABLE PROBES : : : : : DISPOSABLE PROBES DISPOSABLE PROBES (REF - 278-5xx-xxx) NOTE: Probe appearance and functions will vary depending on the probe used. Refer to Probe User Insert for Probe Type Definitions.

  • Page 12: Setup And Interconnect Section

    -UP OF RF GENERAT T T T T OR: -UP OF RF GENERA 1. The RF Generator should be placed on a Stryker cart or on any sturdy table or platform. Refer to hospital procedures or local codes for detailed information.
  • Page 13 CUT Level will default to a level appropriate for the probe used, and the COAG level will default to MED. Refer to the SERFAS Probe User Insert and Appendix B of this manual for definition of CUT/...

  • Page 14: Instructions For Use

    The maximum and default CUT Level can range from 1 to 10 depending on the type of probe being used. Refer to the Probe Family Definition table located in the SERFAS Probe User Insert. 2. Activation of the CUT Mode can be achieved by pressing the yellow pedal of the Footswitch, or by pressing the yellow button on the Probe, if available (NOTE: Some models of the Probe do not have hand-control capabilities).

  • Page 15: Volume Adjustment

    OICE SELECTION: The user has the option to select the type of audio feedback preferred. Either tone or voice feedback is available with SERFAS. To select between the two, use the Tone/Voice Selector located on the back panel of the Generator.

  • Page 16: Changing Probes During Surgery

    INSTRUCTIONS FOR USE CHANGING PR CHANGING PROBES DURING SUR CHANGING PR OBES DURING SUR OBES DURING SUR OBES DURING SURGER GERY Y Y Y Y : : : : : CHANGING PR CHANGING PR OBES DURING SUR Twist Connector Detach NOTE: Be sure that system is not delivering RF energy while changing probes.

  • Page 17: After Surgery

    INSTRUCTIONS FOR USE AFTER SUR AFTER SUR AFTER SUR AFTER SUR AFTER SURGER GERY Y Y Y Y : : : : : 1. Detach Probe from Handpiece Cable. 2. Withdraw Probe from the patient. Be sure that the Probe is NOT activated during withdrawal. 3.

  • Page 18: Cleaning And Sterilization

    TSWITCH TSWIT Wipe the outside of the SERFAS Footswitch with a mild detergent and water according to standard hospital practices. Do not disassemble the SERFAS Footswitch. Do not sterilize the SERFAS Footswitch. Do not immerse the SERFAS Footswitch in liquid. Use only non-abrasive cleaning agents and DO NOT allow liquid to enter connectors.
  • Page 19 CLEANING AND STERILIZATION STERILIZATION: The recommended sterilization parameters are only valid with sterilization equipment that is properly maintained and calibrated. The Handpiece Cable can be sterilized using one of the following methods: 1. EtO Sterilization 2. Steam Sterilization NOTE: Handpiece Cables can be sterilized and should be replaced if inspection indicates any damage. 1.

  • Page 20: Equipment Disposal Guidelines

    EQUIPMENT DISPOSAL GUIDELINES EQUIPMENT DISPOSAL GUIDELINES The SERFAS Generator contains electronic printed circuit assemblies. Equipment should be disposed of at the end ● of its useful life in accordance with applicable national or institutional related policies relating to obsolete electronic equipment.

  • Page 21: Error Codes And Troubleshooting Guide

    ERROR CODES & TROUBLESHOOTING GUIDE If a fault condition should occur, one of the displays on the front panel will display an error code and an error beep will sound. The interpretation of the error code, as well as possible causes and solutions are listed in Table 1. NOTE: To recover system from Errors E1 –...
  • Page 22 NOTE: If disturbance occurs on the video monitor or any other electronic instrument, the user should: Ensure that Handpiece Cable is not near any other instrument cables. ● Ensure that Endoscope has a non-metallic coupling ring (i.e. Stryker CE Mark Endoscopes). ●...

  • Page 23: Technical Specifications

    Shaft Bend Angle ........................0 – 45º Active Tip Orientation ......................0 – 90º Supplied Sterile and For Single-use ONLY Sterilization Method ......................Irradiation SERFAS Handpiece Cable Overall Length ......................9ft. 9in (2.97m) Sterilization Method ....................EtO or Steam Supplied Non-sterile...
  • Page 24 TECHNICAL SPECIFICATIONS Maximum Open Circuit Voltage Coag Level vs. Peak Voltage Cut Level vs. Peak Voltage Coag Level Cut Level Resistance vs. Power (Coag) Resistance vs. Power (Cut) Cut Level 10 Coag Level C3 Coag Level C5 Cut Level 5 1000 1000 Resistance (ohms)

  • Page 25: Product Classifications

    PRODUCT CLASSIFICATIONS CONFORMANCE TO STANDARDS 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety ● 60601-1-2, Medical Electrical Equipment: Electromagnetic Compatibility Requirements and Tests ● 60601-1-4, Medical Electrical Equipment: General Requirements for Programmable Electrical Medical ● Systems 60601-2-2, Medical Electrical Equipment: Particular Requirements for the Safety of High Frequency Surgical ●...

  • Page 26: Maintenance

    NOTE: Refer calibration and operating difficulties not detailed in this manual to your Stryker Endoscopy sales representative, or Stryker Endoscopy Customer Service (in the United states: 1-800-624-4422 / 408-754- 2000).

  • Page 27: Service And Claims

    All specifications are subject to change without notice. Please contact your local Stryker Endoscopy Distributor (listed on pages 24-25) or call your local Stryker Endoscopy sales representative or agent for information on changes and new products.

  • Page 28: Other Service

    VICE THER SER VICE For service in the U.S.A., call your Stryker Endoscopy representative or Stryker Endoscopy Customer Service at 1- 800-624-4422. Outside of the U.S.A., please contact your Stryker Endoscopy distributor at one of the following locations: Stryker Corporation...
  • Page 29 JAPAN INDIA Phone: 81-3-3814-7901 Phone: 91-11-686-2567 Fax: 81-3-3814-8073 Fax: 91-11-651-5496 Stryker China Stryker Mexico, S.A. de C.V. Room 1710, Kodak House Montecito No. 38 39 Healthy Street East Piso 12, Oficina 31 North Point Colonia Napoles HONG KONG MEXICO 03810...

  • Page 30: Warranty

    These products are being sold only for the purpose described herein, and such warranty only runs to the purchaser. In no event shall Stryker Endoscopy be liable for any breach of warranty in any amount exceeding the purchase price of the product.
  • Page 31 Family Definition table located in the SERFAS Probe User Insert. **COAG HIGH, MEDIUM, and LOW settings are selected from C1 – C5, depending on probe type used. Refer to the Probe Family Definition table located in the SERFAS Probe User Insert.
  • Page 32 APPENDIX B DESCRIPTION OF LABELING (RF Generator: Front and Rear Panels) Alternating Current Attention: consult accompanying documents Dangerous Voltage Defibrillator-proof, Type CF Applied Part Equipotential Ground Fuses Non-Ionizing Radiation Power OFF Power ON Relative Humidity Range Temperature Range Probe Footswitch Speaker...
  • Page 33 APPENDIX C LANGUAGE SELECTION INSTRUCTIONS FOR SYNTHESIZED VOICE FEATURE The user may select an alternative language for voice feedback from the selection available. The language selec- tion process should occur during the system self-test (when system is turned ON using the Mains Power Switch). To select a language: 1.
  • Page 35 5900 Optical Court, San Jose CA 95138 USA 1-408-754-2000 1-800-624-4422 1000-400-433 Rev. H...

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