Teleflex Standard Bariatrics TITAN SPU01 Operator's Manual
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Teleflex Standard Bariatrics TITAN SPU01 Operator's Manual

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TITAN Standard Power Unit
Manufactured For:
Standard Bariatrics®
4300 Glendale Milford Rd.
Cincinnati, OH 45242 USA
Phone: 513-620-7751
Page 1 of 28
(SPU01)
Operator's Manual
Uncontrolled Copy
Distributed By:
Teleflex Medical, Inc.
3015 Carrington Mill Blvd.
Morrisville, NC 27560 USA
L0023.L (2023-APR)

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Summary of Contents for Teleflex Standard Bariatrics TITAN SPU01

  • Page 1 TITAN Standard Power Unit (SPU01) Operator’s Manual Manufactured For: Distributed By: Standard Bariatrics® Teleflex Medical, Inc. 4300 Glendale Milford Rd. 3015 Carrington Mill Blvd. Cincinnati, OH 45242 USA Morrisville, NC 27560 USA Phone: 513-620-7751 Page 1 of 28 L0023.L (2023-APR)

  • Page 2: Table Of Contents

    Table of Contents Overview ......................4 Standard Conventions Used ................. 4 Chapter 1 – General Information ..............5 Indications ....................5 Contraindications ..................5 Device Description ..................5 How Supplied ....................5 Illustration and Nomenclature ..............6 Warnings....................... 8 Warnings Continued ..................9 Cautions ......................
  • Page 3 Appendix ......................22 System Specifications ................. 22 Electromagnetic Compatibility (EMC) ............23 Electromagnetic Emissions ................. 23 Electromagnetic Immunity Guidance ............23 Symbols ....................... 25 Page 3 of 28 L0023.L (2023-APR) Uncontrolled Copy...

  • Page 4: Overview

    Overview Please read all information carefully Failure to properly follow instructions may lead to serious surgical consequences. This manual is designed to provide instructions for use for the TITAN Standard Power Unit (SPU01). It contains important information for the operation of the TITAN SPU01. It should be kept easily accessible during use.

  • Page 5: Chapter 1 - General Information

    Chapter 1 – General Information Indications The Titan SGS® linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation. The TITAN Standard Power Unit (SPU01) is intended to be used to power the TITAN Stapler. Contraindications There are no CONTRAINDICATIONS specific to the TITAN SPU01.

  • Page 6: Illustration And Nomenclature

    Illustration and Nomenclature Front Panel of TITAN SPU01: POWER ON/ OFF Glows white when the TITAN SPU01 is powered on BUTTON DEVICE STATUS Displays the status of the TITAN SGS® CLAMP MODE Displays the Status of the TITAN SGS® during “Closure System Mode”...
  • Page 7 Back Panel of TITAN SPU01: SPEAKER PORT Allows sound to escape FAN EXHAUST Provide airflow to the internal components HOLES CAUTION: Do not block POWER ON/ OFF Allows the unit to be powered on from the front SWITCH panel (10) POWER CORD Receptacle used to attach the power cord to the RECEPTACLE...

  • Page 8: Warnings

    Warnings Read all sections of this manual prior to use. Verify the SPU01 is fully operational prior to using the TITAN Stapler (TITAN SGS®). This SPU01 is for use only by qualified medical personnel trained in the proper use of staplers. Inappropriate use or use by untrained medical personnel may result in hazardous electrical output.

  • Page 9: Warnings Continued

    Warnings Continued 18. Ensure that the TITAN SGS® is correctly connected to the SPU01 and that no wires are exposed from the cable, connector or Stapler. 19. In case of system failure, ensure availability of the appropriate backup equipment relevant to the specific procedure. Cautions Removing screws from the front and back panels of the SPU01 or opening of this unit invalidates the warranty and could create hazardous conditions.

  • Page 10: Customer Service

    Customer Service WARRANTY Standard Bariatrics® warrants the SPU01 to be free from defects in material and/or workmanship under normal use for a period of five (5) years. Responsibility of Standard Bariatrics® Standard Bariatrics® is responsible for safety, reliability and performance of the equipment only if: Setup procedures in this manual are followed.

  • Page 11: Chapter 2 - Instructions For Use

    Chapter 2 – Instructions for Use Setup CAUTION: Do not restrict the vents on the back panel of the TITAN SPU01 to avoid overheating. Examine the TITAN SPU01 for any signs of physical damage to. Do not use damaged product. Secure the TITAN SPU01 on a flat surface of a suitable fixture in the appropriate position.

  • Page 12: Spu01 Operating Modes

    SPU01 Operating Modes • SPU01 Initialization – This mode is entered automatically after the TITAN SPU01 is successfully turned on. • Closure System Mode – This mode is entered upon connecting the TITAN SGS® device following initialization. • Timeout – This mode is entered once jaws are fully closed and Safety Button on TITAN SGS®...

  • Page 13: Chapter 3 - Troubleshooting And Audio And Led Indicator Guide

    Chapter 3 – Troubleshooting and Audio and LED Indicator Guide Error Messages The TITAN SPU01 includes integrated diagnostics that monitor the operation of the TITAN SPU01 and TITAN stapler and flash either informative LEDs or announce the message. Error message settings are not adjustable by the operator nor can priority be reassigned.
  • Page 14 SPU01 and TITAN SGS® LED Timing of Occurrence Audible Feedback Indicators Timeout “Timeout. Check jaws to ensure there are no tissue folds, no tissue is present Enter Firing System in the no tissue zone Timeout by depressing and no unintended Safety Button LED blinks green one of the Safety Buttons objects are clamped...
  • Page 15 SPU01 and TITAN SGS® LED Timing of Occurrence Audible Feedback Indicators Pause firing: Fire Mode LED illuminates solid In ‘manual’ mode by green; Firing Progress LEDs continue releasing Trigger Down to operate based on the percentage button complete (i.e. if 50% complete: “Firing Paused”...
  • Page 16 Timing of Audible Feedback LED Indicators Solution Occurrence Closure System Mode or Post Firing Clamp Mode “WARNING: High load Inspect TITAN SGS® Soft close limit of detected. Please jaws; remove Closure System inspect TITAN jaws Device Status LEDs possible Mode reached upon before proceeding.
  • Page 17 No Power Output If there is no power output, attempt to correct this problem using the table below. Possible Cause Solution Turn power on by switching back panel Power On/ Off SPU01 not turned on Switch and depress power button on front panel Confirm electrical connections and then turn power on by SPU01 is not plugged in switching back panel Power On/ Off Switch and depress...

  • Page 18: Electromagnetic Or Other Interference

    Electromagnetic or Other Interference The TITAN SPU01 has been tested and found to comply with the limits for medical devices in IEC 60601-1-2: 2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The TITAN SPU01 generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.

  • Page 19: Chapter 4 - Cleaning, Maintenance And Repair

    Chapter 4 – Cleaning, Maintenance and Repair Electrical Safety Checks The hospital is responsible for ensuring that the TITAN SPU01 has an electrical safety check performed by qualified service personnel at least once a year. CAUTION: Do not remove the screws from the front and back panels of the TITAN SPU01.

  • Page 20: Maintenance, Repair And Service

    Conduct a final confirmation of the cleaning process by visually inspecting the SPU01 and wipe for remaining contamination. If contamination remains on the SPU01 or wipe, repeat steps 1a thru 1e, using a new cleaning wipe. Following cleaning, plug the TITAN SPU01 into a grounded electrical outlet and/or turn the TITAN SPU01 on to verify functionality.

  • Page 21: Chapter 5 - Conformance To Standards

    Chapter 5 – Conformance to Standards The TITAN SPU01 conforms to the following standards: EN (IEC) 60601-1 (with Canadian and US National Deviations) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN (IEC) 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests AIM 7351731 Medical Electrical Equipment and System Electromagnetic...

  • Page 22: Appendix

    Appendix System Specifications Main Fuses 3.15A 250VAC 300VDC Slow Blow Fuse Degree of Protection Type B Against Electrical Shock Class of Protection Class I, Earthed Against Electrical Shock Ingress Protection of IPx0 Enclosure Main Input 100-240V, 50/60 Hz Output Motor Outputs: 15VDC, 0.4A (closure motor) 15VDC, 1.8A (firing motor) Safety Switch LED Outputs:...

  • Page 23: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) The Standard Power Unit requires special precautions regarding electromagnetic capability (EMC) and must be installed and used in accordance with the EMC information provided in this manual. The SPU01 is intended for use in the electromagnetic environments specified below. CAUTION: Ensure that the SPU01 is used only in these environments.
  • Page 24 Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Voltage Dips, 30% Reduction for 30% Reduction for Mains power quality should be Short Interrupts 500mS at 0° phase 500mS at 0° phase that of a typical commercial or and Variation on angle angle...

  • Page 25: Symbols

    Symbols Reference Standard/ Symbol Definition Requirement Catalogue Number ISO 15223-1, Section 5.1.6 Serial Number ISO 15223-1, Section 5.1.7 Manufacturer ISO 15223-1, Section 5.1.1 Distributor ISO 15223-1, Section 5.1.9 Date of Manufacture ISO 15223-1, Section 5.1.3 Use- by Date ISO 15223-1, Section 5.1.4 Non- Sterile ISO 15223-1, Section 5.2.7 Medical Device...
  • Page 26 Reference Standard/ Symbol Definition Requirement CAUTION: Federal (USA) law restricts this device to sale by or on the order of 21 CFR 801, Section 109 a physician IEC 60601-1, Table D.2, No. Refer to Instruction Manual Electrical and Electronic equipment. Return waste to a collection system or Article 11(2) of Directive treatment and recycling facilities.
  • Page 27 Reference Standard/ Symbol Definition Requirement IEC 60601-1, Table D.2, No. General Warning Sign IEC 60601-1, Table D.2, No. Warning, Electricity IEC 60601, Table D.1, No. On (Power) IEC 60601, Table D.1, No. Off (Power) Alternating Current IEC 60601, Table D.1, No. 1 Applied Part Type B (TITAN SGS®, IEC 60601, Table D.1, No.
  • Page 28 SPU01 Manufactured for: Standard Bariatrics 4300 Glendale Milford Road Cincinnati, Ohio 45242 USA Phone: (513) 620-7751 Distributed By: Teleflex Medical, Inc. 3015 Carrington Mill Blvd. Morrisville, NC 27560 USA Page 28 of 28 L0023.L (2023-APR) Uncontrolled Copy...

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