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SECTION 11742
PATIENT EXAMINATION EQUIPMENT


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Copyright 2017 - 2018 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. SECTION INCLUDES

** NOTE TO SPECIFIER ** Delete items below not required for the project.

      1. Scales.

      2. Physical exam equipment sets and systems.

      3. Cardiopulmonary exam equipment.

      4. Medical exam lights and illumination systems.

    1. RELATED SECTIONS

      1. Section 11722 - Patient Monitoring Equipment.

      2. Section 11730 - Patient Handling Equipment

      3. Section 11731 - Hospital Beds and Stretchers.

      4. Section 11761 - Operating Room Equipment and Management Systems

      5. Section 16725 - Health Care Communications and Monitoring Systems.

    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 01300.

      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.

** NOTE TO SPECIFIER ** Delete one of the following two paragraphs; coordinate with requirements of Division 1 section on product options and substitutions.

      1. Substitutions: Not permitted.

      2. Requests for substitutions will be considered in accordance with provisions of Section 01600.

** NOTE TO SPECIFIER ** Delete article if not required.

    1. SCALES

** NOTE TO SPECIFIER ** Delete paragraph if not required.

      1. Basis of Design: Welch Allyn Remote Monitoring Scale RPM-Scale100 as Manufactured by Hill-Rom.

        1. Provides accurate measurements for telemedicine applications. Design includes a built-in carrying handle, sense-on technology, records, transmits and displays patient's weight via LCD. May be wirelessly connected to gateway using Bluetooth 4.0.

        2. Standards Compliance:

          1. FCC Part 15: Class B digital device.

          2. ICES-003: Class B digital apparatus.

          3. EN-1041.

          4. IEC 60601-1 and A1.

          5. IEC 60601-1-11.

          6. IEC 60601-1-2.

          7. IEC/EN 62304 and AC.

          8. IEC 62366.

          9. IEC 60601-1-6.

          10. ISO/EN 14971.

          11. ISO/EN 15223-1.

          12. ISO 10993.

        3. Physical characteristics:

          1. Dimensions (L x W x H): 14-3/16 x 16-1/16 x 1-9/32 in (360 x 408 x 32.5 mm) with optional carpet extension feet.

          2. Net Weight: 6.06 lbs (2.75 kg).

          3. No-slip surface.

          4. Number of load sensors: 4.

          5. Battery compartment: behind cover.

          6. Unit and Activation Button.

          7. Casing Material: Stainless steel.

        4. Mode of Operation: Continuous.

          1. Turns on when patient steps on scale.

          2. Turns of 15 seconds after patient steps off scale.

          3. Memory storage for 200 readings.

        5. Power Supply: 6 V, four DC AAA alkaline batteries.

        6. Display Mode: Blue LCD with White Backlight: 2.9 x 2.1 in (74 x 53 mm).

        7. Display Features: Weight, battery charge, bluetooth status.

        8. Units of Measure: Pounds and kilograms.

        9. Measurement Range: 11 to 441 lbs (5 to 200 kg).

        10. Scale Resolution:

          1. From 0 to 220 lbs: 0.2lbs (0 to 100 kg: 0.1 kg).

          2. From 220 through 440 lbs: 0.5lbs (100 through 200 kg: 0.2 kg).

        11. Environmental Conditions of Operation:

          1. Temperature: 41 to 104 degrees F (5 to 40 degrees C).

          2. Relative Humidity: Less than 85 percent.

          3. Atmospheric pressure: 12.5 to 15.4 psi (86 to 106 kPa)

        12. Environmental Conditions for Storage and Transport:

          1. Temperature: Minus 4 to 140 degrees F (minus 20 to 60 degrees C)

          2. Relative Humidity: 10 to 95 percent

          3. Atmospheric pressure: 7.25 to 15.4 psi (50 to 106 kPa).

        13. Accessories:

          1. AAA alkaline batteries.

          2. Carpet extension feet.

          3. User manual.

** NOTE TO SPECIFIER ** Delete paragraph if not required.

      1. Basis of Design: Welch Allyn ScaleTronix Diaper and Organ 4302 Scale as Manufactured by Hill-Rom.

        1. Stainless steel construction designed for long life and ease of cleaning. Cordless design for easy mobility.

        2. Standards Compliance:

          1. UL544.

          2. CSA C22.2 no. 125.

          3. IEC-601-1.

        3. Physical Characteristics:

          1. Dimensions:

            1. Width: 19 in (482.6 mm).

            2. Height: 31 in (787.4 mm.

            3. Depth: 12 in (304.8 mm.

          2. Platform: 8.5 x 8.5 in (216 x 216 mm).

          3. Net Weight: 34.2 lbs (14.515 kg).

          4. Number of Load Sensors: 1.

          5. Casing Material: Stainless steel.

        4. Control Panel: Designed for operator convenience.

          1. On / Off / Zero.

          2. Pounds / Kilograms.

          3. Reweigh.

          4. Recall.

          5. Battery Operation / Low Battery.

        5. Power Supply. Six, C-sized alkaline batteries; 10,000 weighings.

        6. Power supply: Medical grade UL listed external power supply. 100-240 VAC 50/60 Hz. Captive but replaceable line cord.

        7. Display Mode: Self-contained, digital LED readout.

        8. Display Features:

          1. On / Off / Zero.

          2. Pounds / Kilograms.

          3. Reweigh.

          4. Recall.

          5. Battery Operation/Low Battery.

        9. Units of Measure: Pounds, ounces, or grams.

        10. Measurement Range: Up to 6.61 lbs (3,000 gm).

        11. Measurement Range: Up to 11.02 lbs (5,000 gm) extended capacity.

        12. Scale Resolution: 0.0001 lbs (0.045 grams).

        13. Environmental Conditions of Operation: Keep dry.
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