VA 11 71 01-2011 MEDICAL WASHING AND STERILIZING EQUIPMENT.pdf

1、02-11 11 71 00 - 1 SECTION 11 71 01 MEDICAL WASHING AND STERILIZING EQUIPMENT SPEC WRITER NOTES: 1. Delete between / _ / if not applicable to project. 2. Delete other items or paragraphs in section that are not applicable and renumber the paragraphs. PART 1 - GENERAL 1.1 DESCRIPTIONS This section sp

2、ecifies Medical Reprocessing and Sterilization Equipment including washer disinfectors, cart washers, ultrasonic cleaners, automated endoscope re-processors, steam sterilizers, ethylene oxide (EtO) sterilizer/aerator combination units, ethylene oxide (EtO) abators, plasma sterilizers, ethylene oxide

3、 (EtO) monitoring stations, liquid chemical sterilizers, drying cabinets, detergent dispensing units, water treatment systems, steam guns, and endoscope pre-processing sinks. 1.2 DEFINITIONS A. Ultrasonic Cleaner: A mechanical system that uses sound waves, water and detergent to loosen soil from ins

4、truments. Both countertop and floor units are available. B. Washer/Disinfector: An automated washing unit that uses high-temperature water and detergent to clean and high-level disinfect instruments and trays. 1. Cube Model Single chamber washer/disinfector. 2. Tunnel Model Multiple chamber washer/d

5、isinfector. C. Cart Washer: An automated washing unit that uses high-temperature water and detergent to clean and high-level disinfect carts and equipment. D. Endoscope Drying Cabinet: Freestanding cabinet used to dry endoscopes with forced, filtered air within the cabinet, as well as through the ch

6、annels of the scopes. E. Equipment Drying Cabinet: Freestanding cabinet used to dry equipment with forced, filtered air and variable temperature settings. There are single door and pass-thru units available. F. Automated Endoscopic Re-Processor (AER): Automated washing unit that uses water and EPA-a

7、pproved high level disinfectants to clean and high level disinfect immersible, flexible endoscopes. G. Steam Sterilizer: A machine used to sterilize instruments and equipment by subjecting them to high-pressure steam up to 275F. Sterilizers are Provided by IHSNot for ResaleNo reproduction or network

8、ing permitted without license from IHS-,-,-02-11 11 71 00 - 2 available in both cart-loading and floor-loading models. They can be either freestanding or recessed, with single or double doors (pass-thru). Steam sterilizers are also known as autoclaves. H. Ethylene-Oxide (EtO) Sterilizer/Aerator Comb

9、ination: A machine that combines the sterilization and aeration process into one unit. Ethylene Oxide gas is used to sterilize heat-sensitive instruments and equipment by subjecting them to a temperature of up to 130F, and an aeration cycle immediately follows the sterilization cycle. ETO sterilizer

10、s can be freestanding or recessed, with single doors. A dedicated exhaust system is required for Ethylene Oxide. I. Ethylene Oxide (EtO) Disposal System (Abator): A machine used as a pollution-control device, that converts ethylene oxide gas exhausted from sterilizer/aerator units to CO2 and water v

11、apor through a heated catalytic process. J. Ethylene Oxide (EtO) Monitoring Station: A continuous monitoring device (Single point or multi-point system) used to detect Ethylene Oxide leakage into the room. K. Gas Plasma Sterilizer: A machine that uses hydrogen peroxide gas plasma to sterilize heat-s

12、ensitive instruments and equipment. These sterilizers are available as either floor, cart, or counter-mounted. L. Liquid Chemical Sterilizer: A machine that uses a low-temperature liquid chemical sterilant to process heat-sensitive rigid and flexible endoscopes. M. Water Treatment System: A mechanic

13、al system for use with steam sterilizers, washer/disinfectors and cart washers, that decreases the contaminates in the municipal water to reduce boiler scaling and instrument spotting. N. Detergent Dispensing System: A mechanical system that dispenses measured doses of detergent or other chemicals d

14、irectly to washer disinfectors and cart washers. O. Steam Gun: Refer to Section 23 22 13, STEAM AND CONDENSATE HEATING PIPING. P. Endoscope Pre-Processing Sink: Refer to Section 22 40 00, PLUMBING FIXTURES. 1.3 RELATED WORK A. Section 22 11 00, FACILITY WATER DISTRIBUTION and / Section 22 13 00, FAC

15、ILITY SANITARY SEWERAGE / Section 22 66 00, CHEMICAL-WASTE SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES /:Plumbing Connections. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-02-11 11 71 00 - 3 B. Section 22 15 00, GENERAL SERVICE COMPRESSED-AIR

16、 SYSTEMS: Connections to Compressed Air System. /C. Section 22 40 00, PLUMBING FIXTURES./ D. Section 23 05 11, COMMON WORK RESULTS FOR HVAC. E. Section 23 22 13, STEAM AND CONDENSATE HEATING PIPING: Steam Connections/, Steam Gun/. /F. Section 23 09 23, DIRECT-DIGITAL CONTROL SYSTEM FOR HVAC: Remote

17、monitoring of the Steam Sterilizers and EtO Monitoring system./ G. Section 26 05 11, REQUIREMENTS FOR ELECTRICAL INSTALLATIONS: Electrical Connections. 1.4 PERFORMANCE REQUIREMENTS SPEC WRITER NOTE: Check with user to verify service characteristics required for equipment. A. Equipment shall have bui

18、lt-in monitoring for timed cycles, and control devices for proper temperature and pressure. Equipment shall have a printer, either integrated or remote, for recording cycle time, temperature, and pressure. B. Manufacturer safeguards must be provided with the equipment to protect the operator from ha

19、rm during normal operation of the equipment. 1.5 QUALITY CONTROL A. Refer to Section 23 05 11, COMMON WORK RESULTS FOR HVAC: Quality Assurance 1.3.D - Products Criteria. B. Mechanical, electrical, and associated systems shall be safe, reliable, efficient, durable, easily and safely operable, maintai

20、nable, and accessible. C. Standard Products: Material and equipment shall be the standard products of the selected manufacturer, and they should be regularly engaged in the manufacture of such products for at least 3 years. The design, model and size of each item shall have been in satisfactory and

21、efficient operation on at least three installations for approximately three years. However, digital electronics devices, software and systems such as controls, instruments, computer work stations, shall be the current generation of technology and basic design that has a proven satisfactory service r

22、ecord of at least three years. D. All items furnished shall be free from defects that would adversely affect the performance, maintainability and appearance of individual components and overall assembly. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-

23、,-02-11 11 71 00 - 4 E. Multiple Units: When two or more units of materials or equipment of the same type or class are required, these units shall be products of one manufacturer. F. Nameplates: Nameplate bearing manufacturers name or identifiable trademark shall be securely affixed in a conspicuous

24、 place on equipment, or name or trademark cast integrally with equipment, stamped or otherwise permanently marked on each item of equipment. G. Installer Qualifications: Installer is authorized representative of sterilizer manufacturer and employs factory-trained personnel to install sterilizers. In

25、staller is licensed as may be necessary by regulatory organizations. H. Steam Sterilizers: Comply with the most current version of ANSI/AAMI ST8. I. Ethylene-Oxide Sterilizers: Comply with the most current version of ANSI/AAMI ST24. 1.6 SUBMITTALS A. Submit in accordance with specification Section 0

26、1 33 23, SHOP DRAWINGS, PRODUCT DATA, AND SAMPLES. B. Manufacturers Literature and Data: Include the following: 1. Illustrations and descriptions of medical reprocessing equipment. 2. Optional auxiliary equipment and controls. 3. Catalog or model numbers for each component. 4. Utility requirements.

27、C. Shop Drawings: Show details of fabrication, installation, adjoining construction, coordination with mechanical and electrical work, anchorage, and other work required for complete installation. D. Field Test Reports: Provide certification reports from accredited service technicians or installers.

28、 E. Operating Instructions: Comply with requirements in specification Section 01 00 00, GENERAL REQUIREMENTS. 1.7 APPLICABLE PUBLICATIONS A. The publications listed below form a part of this specification to the extent referenced. The publications are referenced in the text by the basic designation

29、only. B. American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI): ST8-2008Hospital Steam Sterilizer, 3rdedition Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-02-11 11 71 00 - 5 ST24-1999 (R2009).

30、Automatic, General-Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities C. National Association of Architectural Metal Manufacturers (NAAMM): AMP 500-06Metal Finishes Manual 1.8 WARRANTY Comply with FAR clause 52.246-21 in all areas excep

31、t for warranty period, which shall be two years for all equipment. 1.9 GUARANTEE PERIOD SERVICES Engage factory-trained authorized manufacturers representatives to perform maintenance service on equipment during guarantee period. 1. Maintenance Service: a. Inspection of equipment at regularly schedu

32、led intervals as defined by the manufacturer. b. Testing, cleaning, adjusting, repairing, and furnishing and installing replacement components as required to maintain equipment in reliable working condition. 2. Maintenance service does not include cleaning, adjusting, repairing, furnishing and insta

33、lling replacement components required because of improper use. PART 2 - PRODUCTS SPEC WRITER NOTES: 1. Show utility service requirements for sterilizers on drawings. 2. Verify that dedicated exhaust service, venting directly to exterior, without recirculating, is supplied for sterilizers. Need for t

34、he dedicated exhaust system should be verified with the manufacturer and the VA Design Manual. 2.1 ULTRASONIC CLEANER SPEC WRITER NOTE: Chamber sizes vary. Insert sizes based on project requirements. A. Floor Model: 1. Chamber: a. Interior: Stainless steel. b. Tank capacity: 11 gallons to 20 gallons

35、. 2. Doors: a. Quantity: Single. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-02-11 11 71 00 - 6 b. Operation: / Manual / Automatic /. 3. Loading: Manual. 4. Heat Source: / Electric /. 5. Temperature: a. Solution tank: 100 - 120F. 6. Electrical Re

36、quirements: / 120V / 208V / 240V /. B. Countertop Model: 1. Chamber: a. Interior: Stainless steel. b. Tank capacity: 3 gallons to 6 gallons. 2. Doors: a. Quantity: Single. b. Operation: Manual. 3. Loading: Manual. 4. Heat Source: Electric. 5. Temperature: a. Solution tank: ambient to 176F. 6. Electr

37、ical Requirements: / 120V / 08V /. 2.2 WASHER/DISINFECTOR SPEC WRITER NOTE: Chamber sizes vary. Insert sizes based on project requirements. A. Tunnel(Multi-Chamber)Model: 1. Interior: Stainless steel. 2. Doors: a. Quantity: Double (Pass-thru). b. Operation: Automatic. 3. Loading: / Manual / Automati

38、c /. 4. Controls: / Microprocessor / PC Based /. 5. Heat Source: / Steam / Electric /. 6. Electrical Requirements: / 208V / 480V /. 7. Standard Cycles: / Wash / Rinse / Dry /. 8. Optional Cycles: / Prewash / Ultrasonic / Thermal Disinfection Rinse /. 9. Temperature: a. Wash Cycle: / 140 180F /. b. R

39、inse Cycle: / 180 - 194F /. B. Cube Model: 1. Chamber Interior: Stainless steel. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-02-11 11 71 00 - 7 2. Doors: a. Quantity: / Single / Double (Pass-thru) /. b. Operation: / Manual / Automatic /. 3. Loadi

40、ng: / Manual / Automatic /. 4. Controls: / Microprocessor / PC Based /. 5. Heat Source: / Steam / Electric /. 6. Electrical Requirements: / 208V / 240V /. 7. Standard Cycles: / Wash / Rinse /. 8. Optional Cycles: / Purified Water Rinse / Dry /. 9. Temperature: a. Wash Cycle: 140 - 180F. b. Rinse Cyc

41、le: 158 - 194F. 2.3 CART WASHER SPEC WRITER NOTE: Chamber sizes vary. Insert sizes based on project requirements. A. Interior: Stainless steel. 1. Chamber Capacity: 134 241 cu. ft. B. Doors: 1. Quantity: / Single (Pass-thru) / Double (Pass-thru) /. 2. Operation: Automatic. C. Controls: / Microproces

42、sor / PC Based /. D. Heat Source: / Steam / Electric /. E. Electrical Requirements: / 208V / 380V / 480V / 600V /. F. Standard Cycles: / Wash / Rinse / Dry /. G. Optional Cycles: Thermal Disinfection Rinse. H. Installation Options: / Floor mount / Pit mount /. I. Temperature: 1. Wash Cycle: 120 - 18

43、0F. 2. Rinse Cycle: 180 - 194F. J. Loading: Manual. 2.4 ENDOSCOPE DRYING CABINET A. Chamber: 1. Interior: / Painted steel / Stainless Steel /. 2. Capacity: Up to 10 Endoscopes. B. Doors: 1. Quantity: / Single / Double /. 2. Operation: Manual. Provided by IHSNot for ResaleNo reproduction or networkin

44、g permitted without license from IHS-,-,-02-11 11 71 00 - 8 3. Configuration: / Side hinged / Front opening / Back opening (Pass Through) /. C. Loading: Manual. D. Heat Source: Electric: 1. Cabinet Temperature: 149 158 degrees F. 2. Standard Drying Time: 0 - 120 minutes. E. Cabinet Filtration: HEPA

45、filtered air through chamber and internal endoscope channels. F. Air Flow Monitoring: Constant. G. Electrical Requirements: 120V. 2.5 EQUIPMENT DRYING CABINET A. Chamber: 1. Interior: Stainless steel. 2. Capacity: Up to 9 Shelves or cassettes. B. Doors: 1. Quantity: / Single / Double (Pass Through)

46、/. 2. Operation: Manual. 3. Configuration: / Side hinged / Front opening / Back opening (Pass Through) /. C. Loading: Manual. D. Heat Source: Electric. 1. Cabinet Temperature: 158 194 degrees F. 2. Standard Drying Time: 0 - 90 minutes. E. Cabinet Filtration: HEPA filtered air. F. Electrical Requirem

47、ents: 120V. 2.6 AUTOMATIC ENDOSCOPE RE-PROCESSOR (AER) SPEC WRITER NOTE: Chamber configurations vary. Insert sizes based on project requirements. A. Configuration: Free Standing. B. Chamber: 1. Chamber Quantity: / Single / Double / Triple /. 2. Chamber Processing Capacity: / 1 scope / 2 scopes /. C.

48、 Standard Cycle: 1. Time: 22 42 minutes. D. Printer: / Integrated / Remote Printer /. E. Water Pressure: 30 70 PSI. F. Electrical Requirements: / 110V / 120V / 208V / 220V / 230V / 460V /. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-02-11 11 71 00 - 9 2.7 STEAM STERILIZER SPEC WRITER NOTE: Chamber sizes vary. Insert sizes based on project requirements. A. Chamber: 1. Interior: Stainless steel. 2. Chamber Sizes: / Small (4.6 to 9.7 cu. ft.) / Me