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Sartorius Stedim Biotech QuickSeal Cutter Operating Manual

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Operating Manual
QuickSeal
Cutter
®
Large Diameter Cutter
85037-551-17

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Summary of Contents for Sartorius Stedim Biotech QuickSeal Cutter

  • Page 1 Operating Manual QuickSeal Cutter ® Large Diameter Cutter 85037-551-17...
  • Page 2 Read and understand all of the instructions and safety information in this manual before operating or servicing this tool.

  • Page 3: Table Of Contents

    Contents Contents 1 Introduction ............... . 1.1 Description .

  • Page 4: Introduction

    − 6,718,870 − 7,086,979 − 7,254,982 All specifications are nominal and may change as design improvements occur. Sartorius Stedim Biotech and Sartorius AG shall not be liable for damages from misapplication or misuse. Declaration of Conformity see page 29. QuickSeal ®...

  • Page 5: Symbols Used

    Introduction 1.4 Symbols Used As a means of instruction and direct warning of hazards, all important text statements in these installation instructions will be marked as follows: This instruction denotes a possible danger with medium risk of death or severe injury if not avoided.

  • Page 6: General Safety Rules

    General Safety Rules 2 General Safety Rules Read all instructions. Failure to follow all instructions listed below may result in electric shock, fire and | or serious injury. The term “power tool” in all of the warnings listed below refers to your mains operated (corded) power tool or battery operated (cordless) power tool, also machines and electric units.
  • Page 7 Use of the power tool for operations different from those intended could result in a hazardous situation. All unauthorized modifications to the power tool are prohibited for safety reasons. Service − Have the power tool repaired by Sartorius Stedim Biotech before use. QuickSeal ® Cutter...

  • Page 8: Important Safety Information

    Inspect tool and blades before use. A damaged or improperly assembled tool can break and strike nearby personnel. Contact Sartorius Stedim Biotech for necessary repairs. Failure to observe this warning could result in severe injury or death.
  • Page 9 Important Safety Information Do not operate in explosive atmospheres, such as in the presence of flammable liquids, gases or dusts. Power tools create sparks which may ignite the dust or fumes. Stay alert, be aware of what you are doing and use common sense when operating a power tool.
  • Page 10 Important Safety Information − Do not immerse the batteries in liquid. Liquid may create a short circuit and damage the battery. If batteries are immersed, contact your service center for proper handling. − Do not place battery into a pocket, tool pouch, or tool box with conductive objects.

  • Page 11: Overview

    Overview 4 Overview Pos. Description Cutting Head Retract Button LCD Screen Battery Cartridge Lanyard Ring LED Worklight (white) Tube Guides Trigger Tube Guides QuickSeal ® Cutter...

  • Page 12: Operation

    Operation 5 Operation Inspect tool and blades before use. A damaged or improperly assembled tool can break and strike nearby personnel. Contact Sartorius Stedim Biotech for necessary repairs. Failure to observe this warning could result in severe injury or death.

  • Page 13: Cutting The Collar

    Operation 5.3 Cutting the Collar Install the battery into the base of the QUICKSEAL cutting tool. Be sure the ® trigger is not depressed during battery installation. The cutting head should be fully open. Push and hold the retract button until cutting head is fully open.

  • Page 14: Maintenance

    Place the tool into the carrying case. Store in a cool, dry place. Charge the battery. 6.2 Monthly Thoroughly clean all surfaces. 6.3 Annually (or after 10,000 cuts) Return the tool to Sartorius Stedim Biotech for inspection (see also Chapter “10 Appendix”, page 28). QuickSeal ® Cutter...

  • Page 15: Preventative Maintenance

    Since manufacturing: operating hours, capacity, number of cycles Maintenance and Service must be performed by qualified personnel only. Return the tool to Sartorius Stedim Biotech for maintenance. Consult Sartorius Stedim Biotech for a maintenance schedule on high-frequency cutting. QuickSeal ®...

  • Page 16: Correction Of Defects

    Correction of defects 7 Correction of defects 7.1 Before You Begin Make sure that the battery is charged. Re-check after several minutes to make sure the battery is holding its charge. Use a non-flammable contact cleaner or pencil eraser to clean electrical contacts on the battery and cutting tool.

  • Page 17: Technical Data

    Technical Data 8 Technical Data 8.1 Cutting Capacities QUICKSEAL QUICKSEAL ® ® Tube Size Collar Size Collar Length (o.d.) (o.d.) 4” QUICKSEAL 0.281” 1.500” ® 4” a” QUICKSEAL 0.435” 2.000” ® a” 0.498” 2.125” e” QUICKSEAL ® e” 0.573” 2.250” 1”...

  • Page 18: Risk Assessment

    Risk Assessment 9 Risk Assessment As referred in the CE Certificate the risk assessment considers the possible hazards when using the tool, the potential of the risk and safety measures to mitigate the risk. Position Possible Risk according to Risk Operational Body Part | Possible Cause according to...
  • Page 19 Risk Assessment Possible Occurrence Importance Perception Risk-factor Safety Measures Info to Consequences of Risk Cuts and bruises Decal on tool. R&D2 Warning in IM Closing speed < 10 mm/s Cuts and bruises Decal on tool. R&D2 Warning in IM QuickSeal ®...
  • Page 20 Risk Assessment Position Possible Risk according to Risk Operational Body Part | Possible Cause according to EN 14121-1 Step or Place Persons EN 12100, Annex A Procedure and Property Thermal radiation or other phenomena such as the projection of molten particles and chemical effects from short circuits, overloads, etc.
  • Page 21 Risk Assessment Possible Occurrence Importance Perception Risk-factor Safety Measures Info to Consequences of Risk QuickSeal ® Cutter...
  • Page 22 Risk Assessment Position Possible Risk according to Risk Operational Body Part | Possible Cause according to EN 14121-1 Step or Place Persons EN 12100, Annex A Procedure and Property Inadequate design or location of visual display units Combination of Hazards Unexpected start-up, unexpected over-run | over-speed 10,1...
  • Page 23 Risk Assessment Possible Occurrence Importance Perception Risk-factor Safety Measures Info to Consequences of Risk QuickSeal ® Cutter...
  • Page 24 Risk Assessment Position Possible Risk according to Risk Operational Body Part | Possible Cause according to EN 14121-1 Step or Place Persons EN 12100, Annex A Procedure and Property 21,4 Mechanical hazards at the work position: a) contact with the wheels b) rollover c) fall of objects, penetration d) break-up of parts rotating...
  • Page 25 Risk Assessment Possible Occurrence Importance Perception Risk-factor Safety Measures Info to Consequences of Risk QuickSeal ® Cutter...
  • Page 26 Risk Assessment Position Possible Risk according to Risk Operational Body Part | Possible Cause according to EN 14121-1 Step or Place Persons EN 12100, Annex A Procedure and Property Mechanical hazards and hazardous events 27,1 from load falls, collisions, machine tipping caused by: 27.1.1 lack of stability...
  • Page 27 Risk Assessment Possible Occurrence Importance Perception Risk-factor Safety Measures Info to Consequences of Risk QuickSeal ® Cutter...

  • Page 28: Appendix

    Appendix 10 Appendix 10.1 Service Repairs and service must be performed by authorized personnel. Returning Devices Devices requiring service should be sent to Sartorius. Please complete the Service Maintenance and Request Form. E-mail the completed form to QualityNOX.NA@sartorius.com Your request will be reviewed and a repair number will be assigned to the tool and shipping instructions will be emailed.

  • Page 29: Ce Declaration Of Conformity

    Appendix 10.3 CE Declaration of Conformity EG-/EU-Konformitätserklärung EC / EU Declaration of Conformity Sartorius Stedim North America Inc. Hersteller 5 Orville Drive, Bohemia, NY 11716, USA Manufacturer erklärt in alleiniger Verantwortung, dass das declares under sole responsibility that the handgeführte motorbetriebene Elektroschneidewerkzeug für pharmazeutische Anwendungen Geräteart / Schläuche Device type...

  • Page 30: Service And Maintenance Request Form

    Appendix 10.4 Service and Maintenance Request Form QUICKSEAL® Large Diameter Cutting Tool Service and Maintenance Request Form Company Name: Shipping Address: Contact Name: email address: Phone Number: Part Number for Service: Serial Number: Other General Comments on Condition of Tool: Purchase Order Number for Repair and Service: Declaration Concerning the Decontamination and Cleaning of Equipment and Components To protect our personnel, we require that all equipment or components which come into contact with our...
  • Page 31 Appendix QUICKSEAL® Large Diameter Cutting Tool Service and Maintenance Request Form E-mail the completed form to QualityNOX.NA@sartorius.com Your request will be reviewed and a repair number will be assigned to the tool and shipping instructions will be emailed. DO NOT send tools until you receive your repair number. Tools sent in without a repair number may be refused.
  • Page 32 Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, Germany Phone: +49.551.308.0 www.sartorius.com The information and figures contained in these instructions correspond to the version date specified below. Sartorius reserves the right to make changes to the technology, features, specifications and design of the equipment without notice.

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