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SECTION 11 72 13
PATIENT EXAMINATION EQUIPMENT


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Copyright 2017 - 2017 ARCAT, Inc. - All rights reserved

** NOTE TO SPECIFIER ** Hill-Rom, Welch Allyn Division; patient examination equipment.
This section is based on examination products of Welch Allyn, a Division of Hill-Rom, and exam lights and lighting systems of Hill-Rom; health care industry products and solutions:
Welch Allyn, a Division of Hill-Rom
4341 State Street Road
Skaneateles Falls, NY 13153
USA
Toll Free: 1-800-535-6663
www.welchallyn.com
Click Herefor additional information.
Hill-Rom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.
Hill-Rom: Enhancing outcomes for patients and their caregivers.


  1. GENERAL

    1. RELATED SECTIONS

      1. Section - .

      2. Section 11 73 00 - Patient Care Equipment

      3. Section 11 73 00 - Patient Care Equipment.

      4. Section -

      5. Section - .

    2. REFERENCES

** NOTE TO SPECIFIER ** Delete references from the list below that are not actually required by the text of the edited section.

      1. Association for the Advancement of Medical Instrumentation (AAMI).

      2. American National Standards Institute (ANSI):

        1. ANSI/AAMI EC11 - Diagnostic Electrocardiographic Devices.

        2. ANSI/AAMI EC53 - ECG Trunk Cables and Patient Leadwires.

        3. ANSI/AAMI SP10 - Manual, Electronic, or Automated Sphygmomanometers.

      3. Australian and New Zealand Standard (AS/NZS):

        1. AS/NZS 3200.1.01 - Medical Electrical Equipment - Part 1.0: General Requirements for Safety - Parent Standard.

      4. ASTM International (ASTM):

        1. ASTM D4332 - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing.

        2. ASTM E1104 - Standard Specification for Clinical Thermometer Probe Covers and Sheaths.

      5. CSA Group (CSA):

        1. CAN/CSA C22.2 No 125 - Electromedical Equipment.

        2. CAN/CSA C22.2 NO.601.1-M90 - Medical Electrical Equipment Part 1: General Requirements for Safety.

        3. CAN/CSA C22.2 No. 601.1.1 - Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard Safety Requirements Fort Medical Electrical Systems.

        4. CAN/CSA C22.2 No. 601.1.2 - Medical Electrical Equipment - Part 1: General Requirements for Safety - 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

        5. CAN/CSA-C22.2 No.60601-1-2 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and Tests (IEC 60601-1-2 with Canadian Deviations).

        6. CAN/CSA Z9919 - Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use.

      6. European Commission (EEC).

      7. European Standards (EN):

        1. EN 1041 Information Supplied by the Manufacturer of Medical Devices.

        2. EN 1060-1 - Non-Invasive Sphygmomanometers. General requirements.

        3. EN 1060-3 - Non-Invasive Sphygmomanometers. Supplementary Requirements for Electro-Mechanical Blood Pressure Measuring Systems.

        4. EN/IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

        5. EN/IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

        6. EN/IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.

        7. EN/IEC 60601-1-8 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

        8. EN/IEC 60601-2-25 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

        9. EN/IEC 60601-2-49 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment.

        10. EN/IEC 62304 - Medical Device Software - Software Life Cycle Processes.

        11. EN/ISO 9919 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

        12. EN/ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes.

        13. EN/ISO 14971 - Medical devices - Application of risk management to medical devices.

      8. Federal Communications Commission (FCC):

        1. FCC Part 15 Subpart C: - Intentional Radiators. The FCC definition is "A device that intentionally generates and emits radio frequency energy by radiation or induction."

      9. Innovation, Science and Economic Development Canada (ICES):

        1. CES-003 Information Technology Equipment (Including Digital Apparatus) Limits and Methods of Measurement.

      10. International Electrotechnical Commission (IEC):

        1. IEC 601-1 - Part 1: General Requirements for Safety, Medical Electrical Equipment.

        2. IEC 60601-1 and A1 Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance.

        3. IEC 60601-1-11 Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

        4. IEC/EN 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic compatibility - Requirements and Tests.

        5. IEC/EN 62304 and AC Medical Device software - Software Life Cycle Processes.

        6. IEC 62366 Medical Devices - Application of Usability Engineering to Medical Devices.

        7. IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.

      11. International Organization for Standardization (ISO):

        1. ISO/EN 14971 - Medical Devices. Application of Risk Management to Medical Devices.

        2. ISO/EN 15223-1 Medical Devices. Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied. General Requirements.

        3. ISO 10993 Biocompatibility Testing.

      12. International safe Transit Association (ISTA):

        1. ISTA 2A - Partial Simulation Performance Tests.

      13. National Fire Protection Association (NFPA):

      14. European Medical Devices Directive (MDD):

      15. Underwriter's Laboratories (UL:

        1. UL 544 - UL Standard for Safety Medical and Dental Equipment.

        2. UL 60601-1 - Medical Electrical Equipment, Part 1: General Requirements for Safety.

    1. SUBMITTALS

      1. Submit under provisions of Section 01 30 00 - Administrative Requirements.

      2. Product Data: Manufacturer's data sheets on each product to be used, including:

        1. Source quality certificates.

        2. Pre-Installation Manual: Preparation instructions and recommendations.

        3. Installation Manual: Storage and handling requirements and recommendations.

        4. Installation Manual: Installation methods.

        5. Service Manual: Maintenance and operations data.

      3. Shop Drawings: Include system components, utility requirements and connections, relationship with adjacent construction. Include required clearances and access for servicing.

        1. Communications wire labeling schedules.

        2. Communications wiring diagrams.

        3. Plans and elevations of telecommunications room.

        4. Pathways.

        5. Access points.

        6. Grounding.

        7. MEP systems.

    2. QUALITY ASSURANCE

      1. Regulatory Requirements: Comply with requirements of authorities having jurisdiction and applicable codes at the location of the project.

      2. Manufacturer Qualifications: Minimum 5 years' experience manufacturing similar products.

      3. Installer Qualifications: Minimum 2 years' experience installing similar products.

    3. DELIVERY, STORAGE, AND HANDLING

      1. Deliver and store products in manufacturer's unopened packaging bearing the brand name and manufacturer's identification until ready for installation.

      2. Comply with manufacturer's recommendations. Handle materials to avoid damage.

    4. PROJECT CONDITIONS

      1. Maintain environmental conditions (temperature, humidity, and ventilation) within limits recommended by manufacturer for optimum results. Do not install products under environmental conditions outside manufacturer's recommended limits.

    5. WARRANTY

      1. Provide manufacturer's standard limited warranty.

  1. PRODUCTS

    1. MANUFACTURERS

      1. Acceptable Manufacturer: Welch Allyn, a Division of Hill-Rom 4341 State Street Road, Skaneateles Falls, NY 13153. ASD. Toll-Free: 800-535-6663. www.welchallyn.com.

      2. Requests for substitutions will be considered in accordance with provisions of Section 01 60 00 - Product Requirements.

  2. EXECUTION

    1. EXAMINATION

      1. Verification of Conditions: Examine areas and conditions under which Work is to be performed and identify conditions that may be detrimental to proper or timely completion.

      2. Do not proceed until unsatisfactory conditions have been corrected.

    2. INSTALLATION

      1. General: Install per manufacturer's written instructions and in proper relationship with adjacent construction.

      2. Testing: Test per manufacturer's written instructions. Adjust until satisfactory results are obtained. If satisfactory results cannot be obtained, replace unit at no additional cost to the Owner.

    3. CLEANING AND PROTECTION

      1. Protect from damage during construction operations. Promptly repair any damaged surfaces. Remove and replace work which cannot be satisfactorily repaired.

      2. Clean products, prior to Substantial Completion, using materials recommended by the manufacturer.


END OF SECTION

11 72 13-

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