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Table of Contents
Related Manuals for Quest Engineering ART-LAP-0008
Summary of Contents for Quest Engineering ART-LAP-0008
- Page 1 Laparoscope Instructions for Use...
- Page 2 Laparoscope Instructions for Use...
- Page 3 Corporate Headquarters Quest Medical Imaging B.V. Industrieweg 41 1775 PW Middenmeer The Netherlands Website: www.quest-mi.com Customer Service and Technical Support Email: info@quest-mi.com Phone: +31-227-60-40-46 Fax: +31-227-60-41-85 Contact USA Quest Medical Imaging Everett Building, Suite 501 39 East Market Street, Akron, Ohio 44311 U.S.A. Customer Service and Technical Support Email: info@quest-mi.com Phone: +1-33-07-52-65-96...
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Page 4: Table Of Contents
Quest Spectrum® Laparoscopes Table of Contents Health and Safety Compliance ..................... 2 Important Information ......................2 Indication for Use ........................2 Foreseeable misuse ........................ 2 1.3.1 Contraindications: ......................2 User Qualifications........................3 Repair and Modification ......................3 Labels on Packaging ....................... 3 Safe application and preparation .................... -
Page 5: Health And Safety Compliance
Quest Spectrum® Laparoscopes 1 Health and Safety Compliance 1.1 Important Information WARNING: Read Before Use This instruction manual contains essential information on using the Quest Spectrum® Laparoscopes safely and effectively. Before use, thoroughly review this manual and use the system as instructed. Keep this manual in a safe, accessible location. -
Page 6: User Qualifications
Quest Spectrum® Laparoscopes 1.4 User Qualifications This manual is addressed exclusively to qualified personnel (licensed physician, medical assistants supervised by a licensed physician). The Quest Spectrum® Laparoscope is to be used exclusively by qualified personnel to carry out clinical applications. WARNING: This manual does not explain or discuss clinical procedures. -
Page 7: Safe Application And Preparation
Quest Spectrum® Laparoscopes 2 Safe application and preparation 2.1 Packaging and storage WARNING: The laparoscope is not sterilely packed. Prior to the first sterilization, clean the laparoscope thoroughly (manually or using a machine according to chapter 4). After every use, clean, disinfect and sterilize the laparoscope (see chapter 4 Cleaning/ Disinfection). -
Page 8: Assembly And Disassembly
Laparoscope. Table 2: overview of all laparoscopes provided by Quest Medical Imaging. Line of vision Color Code Field of View Working Length Article Number 30° 70° 290 mm ART-LAP-0008 30° 70° 150 mm ART-LAP-0008S 0° Green 70° 290 mm ART-LAP-0009 0°... -
Page 9: Combinations
Quest Spectrum® Laparoscopes 3.1 Combinations WARNING: Danger to life due to high tensions and currents! Make sure that the leakage currents of the patient are minimized for combinations: Connect the Laparoscopes only to devices and accessories of Quest Medical Imaging. ... -
Page 10: Manual Cleaning/Disinfection
Quest Spectrum® Laparoscopes 3. Soak encrusted laparoscopes and accessories in 3 % H2O2 for 5 minutes before cleaning and disinfection. 4. Use fully desalinated water. Clean manually or in a machine. Observe manufacturer's indications (e.g. dosing). 5. Always machine-clean after contact with: ... -
Page 11: Maintenance, Checking
Quest Spectrum® Laparoscopes 6. Make sure that laparoscopes and accessories are properly secured in the holders. 7. Connect rinsing or working channels of laparoscopes and accessories to rinsing connectors of washer. 8. Use a cleaning agent with a medium pH value (5 - 11). 9. -
Page 12: Sterilization Method
Quest Spectrum® Laparoscopes Clean laparoscopes thoroughly before sterilizing (see chapter 4 Cleaning/disinfection). Make sure that the entire surface is exposed to the sterilization medium. Avoid any contact with metal surfaces. Make sure that laparoscopes are properly secured in the holders. Do not sterilize laparoscopes still in their protective transport sheaths. -
Page 13: Standards/Directives
Quest Spectrum® Laparoscopes 7 Standards/Directives All laparoscopes are manufactured in accordance with the following directives: Medical device directive 93/42 EWG last changed by 2007/47/EG EN ISO 13485 Series of standards IEC 60601 Series of standards ISO 8600 FDA regulations (FDA Quality System Regulation 21 CFR Part 820) other product and material-specific standards and regulations 8 Disposal 8.1 General Remarks... - Page 14 Quest Spectrum® Laparoscopes Declarations of Conformity Manufacturer : Quest Medical Imaging B.V. Industrieweg 41 1775 PW Middenmeer the Netherlands We declare under our sole responsibility that the Quest Spectrum® Laparoscope complies with the following directive: Directive 93/42/EEC-M5 for medical devices 2797 The individual components of your Quest Spectrum®...