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PRODUCTS SHALL MEET ALL OF THE FOLLOWING MINIMUM TECHNICAL REQUIREMENTS:General-Purpose AC-Powered Adjustable Hospital Beds (Standard)DEFINITIONAn AC-powered adjustable hospital bed is a device intended for medical purposes that consist of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails as well as surfaces (i.e., mattresses). INTENDED USEGeneral-purpose AC-powered adjustable hospital beds are used for an adult patient on an inpatient hospital and/or extended care unit for resting and sleeping, and also during recuperation and/or medical treatments (e.g., alternating pressure).General-Purpose AC-Powered Adjustable Hospital Bed Frame (Standard)MTR #Method of EvaluationMTR 1.1GeneralBed shall accept a variety of surfaces (i.e., mattresses) that reduce pressure, shear, friction and moisture.Literature Review MTR 1.2GeneralA list of all compatible surfaces (i.e., mattresses) shall be provided that includes: manufacturer, model, mattress type, dimensions (i.e., length, width, and height), and patient weight capacity.Literature ReviewMTR 1.3GeneralBed frame with a compatible surface (i.e., mattress) shall meet U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, issued on March 10, 2006, which includes the following dimensional limits: Zone 1 (within the rail) less than 120mm; Zone 2 (under the rail, between rail supports or next to a single rail support) less than 120mm; Zone 3 (between rail and mattress) less than 120mm; Zone 4 (under the rail at the ends of the rail) less than 60mm AND greater than 60° angle.Physical InspectionMTR 1.4GeneralBed frame with a compatible surface (i.e., mattress) shall meet the IEC/EN 60601-2-52 bed standard, which includes the following additional dimensional limits: Zone 5 (between split bed rails) less than 120 mm or greater than 318 mm; Zone 6 (between the end of the rail and the side edge of the head or foot board) less than 120 mm; Zone 7 (between the head or foot board and the mattress end) less than 120 mm. Physical InspectionMTR 1.5General Bed deck shall not contain springs.Physical InspectionMTR 1.6DimensionsBed length shall be no less than 80 inches.Physical InspectionMTR 1.7DimensionsBed length shall be electronically adjustable to an additional 12 inches (± 2 inches) without use of tools or additional parts.Physical Inspection General-Purpose AC-Powered Adjustable Hospital Bed Frame (Standard)MTR #Method of EvaluationMTR 1.8DimensionsBed width shall be no less than 36 inches.Physical InspectionMTR 1.9DimensionsBed shall have a fully motorized general-purpose electric bed frame capable of adjusting bed height and surface position. Bed shall descend to a minimum height of 20 inches and rise to a height of 33 inches. Literature Review and Physical InspectionMTR 1.10WeightBed shall support a patient weight of 500 pounds. Literature Review MTR 1.11WeightBed shall be prominently labeled to identify maximum patient weight capacity.Physical InspectionMTR 1.12RailsEnd rails (i.e., headboard and footboard) shall be removable without the use of tools.Physical InspectionMTR 1.13RailsSide rails shall be attached to the bed frame. Physical InspectionMTR 1.14RailsSide rails shall be single hand release and able to be manually raised and lowered, and may be full length, half-length or quarter length.Physical InspectionMTR 1.15ControlsBed shall have separate controls for the patient and the hospital staff (e.g., nurse or caregiver). Literature Review and Physical InspectionMTR 1.16ControlsBed controls shall be integrated into the side rail(s) or contained within a separate hand pendant and are identified with words or symbols.Physical InspectionMTR 1.17ControlsBed controls shall be sealed against fluid penetration. Literature Review and Physical InspectionMTR 1.18ControlsBed controls shall be of the momentary-contact type.Physical InspectionMTR 1.19ControlsBed controls shall NOT be of the walk-away type. Physical InspectionMTR 1.20ControlsBed controls shall include controls for patient lockout and special bed positions (i.e. Trendelenburg, Reverse Trendelenburg, Chair). Physical InspectionMTR 1.21ControlsCaregiver bed controls shall have lockout switches that are inaccessible to the patient and disable the patient bed controls. Physical InspectionMTR 1.22ControlsBed controls shall be illuminated and identified with clearly visible symbols that allows for ease of use.Physical InspectionMTR 1.23FeaturesBed shall have a cardiopulmonary resuscitation (CPR) control function that within 10 seconds (i.e., a period of time of no more than 10 seconds) adjusts the bed to a flat and stable position for the administration of CPR in the event of an emergency. Physical InspectionMTR 1.24FeaturesCPR function/quick release is clearly marked, at the head of the bed, on the right and left sides and is not power dependent. Physical InspectionGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Standard)MTR #Method of EvaluationMTR 1.25FeaturesCPR function shall be accessible without moving the patient, side or end rails, or any other accessory or component attached to the bed frame.Physical InspectionMTR 1.26FeaturesCPR function shall be easily engaged using only one hand in a single motion.Physical InspectionMTR 1.27FeaturesBed shall have an exit-alarm feature. Literature Review and Physical InspectionMTR 1.28FeaturesBed Exit Alarms shall only be able to be engaged and disengaged by staff; patient shall not have accessibility. Literature Review and Physical InspectionMTR 1.29FeaturesBed Exit Alarms shall have an audible alarm and can be integrated into a hospital communication/call system in which the alarm will sound via the call system at a central station and a call light will illuminate over the patient room door.Literature Review and Physical InspectionMTR 1.30FeaturesNurse Call feature shall be clearly visible with symbols and/or text, and easily accessible to the patient.Physical InspectionMTR 1.31FeaturesNurse Call feature shall be integrated into the side rails and contained in a separate hand held pendant. Physical InspectionMTR 1.32FeaturesBed shall have an automatic contour feature (also referred to as auto contour and automatic knee break) that simultaneously bends the knee section of the bed when the head section is raised. Physical InspectionMTR 1.33FeaturesBed shall be retractable such that the foot end moves toward the head of the bed when the head section is raised.Physical InspectionMTR 1.34FeaturesBed shall have a 'move assist' feature for ease in transporting and is not dependent on power.Physical InspectionMTR 1.35FeaturesBed shall allow for transportation in an elevated position.Physical InspectionMTR 1.36FeaturesBed shall have a central brake system that is engaged and disengaged by foot control.Physical InspectionMTR 1.37FeaturesBed shall be capable of special bed positions, such as the chair /cardiac chair position or Trendelenburg/Reverse Trendelenburg.Physical InspectionGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Standard)MTR #Method of EvaluationMTR 1.38FeaturesChanges in bed positions shall be conducted using electrical controls (i.e., head of bed and foot of bed are raised or lowered via use of bed controls).Physical InspectionMTR 1.39FeaturesBed shall allow lifts and other equipment beneath the bed deck. Physical InspectionMTR 1.40FeaturesBed shall have at least two (2) IV Pole Holders. Physical InspectionMTR 1.41FeaturesBed shall support attachment of traction equipment. Literature ReviewMTR 1.42FeaturesBed shall have the capability of position adjustment in the event of a power failure. Physical InspectionMTR 1.43CleaningBed must be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME. Literature ReviewMTR 1.44Standards/ RegulationsBed shall meet ANSI/AAMI/IEC 60601-2:2007/(R) 2012, or equivalent electrical safety standard, that applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems.Literature ReviewMTR 1.45Standards/ RegulationsMedical device manufacturer shall be a registered establishment with the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Establishment Name and Registration Number. Literature Review and Government Database SearchMTR 1.46Standards/ RegulationsMedical device shall be listed with U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Proprietary Device Name.Literature Review and Government Database SearchMTR 1.47Standards/ RegulationsMedical device shall be classified by U.S. Food and Drug Administration (FDA) under AC-powered Adjustable Hospital Bed in accordance with 21 CFR § 880.5100. Provide Classification Name and Product Code. Literature Review and Government Database SearchMTR 2.1GeneralSurface shall contain foam and have the functionally equivalent effect of supporting a patient and avoid excess pressure on local body areas. Physical InspectionNon-Powered, Pressure Reduction, Foam Mattress (Standard)MTR #Method of EvaluationMTR 2.2GeneralSurface shall reduce friction and shear. Literature ReviewMTR 2.3GeneralA list of all compatible bed frames shall be provided that includes: manufacturer, model, mattress type, dimensions (i.e., length, width, and height), and patient weight capacity.Literature ReviewMTR 2.4GeneralSurface (i.e., mattress) with a compatible bedframe shall meet U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, issued on March 10, 2006, which includes the following dimensional limits: Zone 1 (within the rail) less than 120mm; Zone 2 (under the rail, between rail supports or next to a single rail support) less than 120mm; Zone 3 (between rail and mattress) less than 120mm; Zone 4 (under the rail at the ends of the rail) less than 60mm AND greater than 60° angle.Physical InspectionMTR 2.5GeneralSurface (i.e., mattress) with a compatible bedframe shall meet the IEC/EN 60601-2-52 bed standard, which includes the following additional dimensional limits: Zone 5 (between split bed rails) less than 120 mm or greater than 318 mm; Zone 6 (between the end of the rail and the side edge of the head or foot board) less than 120 mm; Zone 7 (between the head or foot board and the mattress end) less than 120 mm. Physical InspectionMTR 2.6DimensionsSurface length shall be 80 inches (+/- 1 inch). Physical InspectionMTR 2.7DimensionsSurface width shall be 36 inches (+/- 1 inch). Physical InspectionMTR 2.8WeightSurface shall support a patient weight of 500 pounds. Literature ReviewMTR 2.9WeightSurface shall be prominently labeled to identify maximum patient weight capacity. Physical InspectionMTR 2.10CoverSurface cover shall be bacteria resistant, flame retardant, fluid impenetrable, anti-fungal, anti-static, non-allergenic and non-shearing.Literature ReviewMTR 2.11CoverSurface cover shall be vinyl and/or nylon.Literature ReviewMTR 2.12FeaturesSurface interior and exterior shall be free of toxins, including: cadmium, mercury, asbestos, PVC/DEHP, PCB, and CFC. Literature Review MTR 2.13FeaturesSurface shall not be made with natural rubber latex. Literature ReviewNon-Powered, Pressure Reduction, Foam Mattress (Standard)MTR #Method of EvaluationMTR 2.14FeaturesSurface shall be multi-zoned (i.e., a mattress that has different segments that have different pressure distribution characteristics to help reduce the development of bed sores in areas where they are most likely to develop, such as the head, body and foot) to match the body’s proportional differences maximizing pressure redistribution to the head, body and foot. Physical InspectionMTR 2.15FeaturesSurface shall not inhibit or restrict the ability to raise and lower the side rails of the bed frame. Physical InspectionMTR 2.16FeaturesSurface shall be compatible with bed exit alarms so as not to compromise alarm function.Literature ReviewMTR 2.17FeaturesSurface shall contain non-powered air support chambers or cylinders, which can be manually adjusted via use of a pump, but are not dependent upon power to maintain pressure reduction. Physical InspectionMTR 2.18FeaturesSurface shall secure to the bed frame (e.g. magnets/Velcro, anti-skid bottom) so that surface does not slip/slide or migrate when bed is placed in fowlers or Trendelenburg positions. Physical InspectionMTR 2.19CleaningSurface must be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature ReviewMTR 2.20Standards/ RegulationsSurface shall meet all State and Federal safety standards which includes fire regulations. Literature ReviewMTR 2.21Standards/ RegulationsSurface shall meet the standards for the flammability of mattress sets (i.e., 16 CFR Part 1633, 16 CFR Part 1632). Literature Review MTR 2.22Standards/ RegulationsSurface shall be labeled in accordance with U.S. Food and Drug Administration’s (FDA’s) guidance for Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex issued on December 2, 2014. Literature Review Non-Powered, Pressure Reduction, Foam Mattress (Standard)MTR #Method of EvaluationMTR 2.23Standards/ RegulationsMedical device manufacturer shall be a registered establishment with the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Establishment Name and Registration Number. Literature Review and Government Database SearchMTR 2.24Standards/ RegulationsMedical device shall be listed with U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Proprietary Device Name. Literature Review and Government Database SearchMTR 2.25Standards/ RegulationsMedical device shall be classified by U.S. Food and Drug Administration (FDA) under non-powered flotation therapy mattress in accordance with 21 CFR § 880.5150. Provide Classification Name and Product Code. Literature Review and Government Database SearchLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Standard)MTR #Method of EvaluationMTR 3.1GeneralSurface shall consist of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. Literature ReviewMTR 3.2GeneralSurface shall reduce friction and shear. Literature ReviewMTR 3.3GeneralA list of all compatible bed frames shall be provided that includes: manufacturer, model, mattress type, dimensions (i.e., length, width, and height), and patient weight capacity.Literature ReviewMTR 3.4GeneralSurface (i.e., mattress) with a compatible bedframe shall meet U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, issued on March 10, 2006, which includes the following dimensional limits: Zone 1 (within the rail) less than 120mm; Zone 2 (under the rail, between rail supports or next to a single rail support) less than 120mm; Zone 3 (between rail and mattress) less than 120mm; Zone 4 (under the rail at the ends of the rail) less than 60mm AND greater than 60° angle.Physical InspectionMTR 3.5GeneralSurface (i.e., mattress) with a compatible bedframe shall meet the IEC/EN 60601-2-52 bed standard, which includes the following additional dimensional limits: Zone 5 (between split bed rails) less than 120 mm or greater than 318 mm; Zone 6 (between the end of the rail and the side edge of the head or foot board) less than 120 mm; Zone 7 (between the head or foot board and the mattress end) less than 120 mm. Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Standard)MTR #Method of EvaluationMTR 3.6DimensionsSurface length shall be 80 inches (+/- 1 inch). Physical InspectionMTR 3.7DimensionsSurface width shall be 36 inches (+/- 1 inch). Physical InspectionMTR 3.8DimensionsSurface height when fully inflated shall be no less than 5 inches.Physical InspectionMTR 3.9DimensionsSurface height when fully inflated shall not exceed 10 inches and not raise equal to or exceed the height of the side rails.Physical InspectionMTR 3.10WeightSurface shall support a patient weight of 500 pounds. Literature Review MTR 3.11WeightSurface shall be prominently labeled to identify maximum patient weight capacity. Physical InspectionMTR 3.12CoverSurface cover shall be bacteria resistant, flame retardant, fluid impenetrable, anti-fungal, anti-static, non-allergenic and non-shearing.Literature Review MTR 3.13CoverSurface cover shall be vinyl and/or nylon.Literature Review MTR 3.14ControlsSurface controls shall be on the front panel of the bed and secured on bed frame. Physical InspectionMTR 3.15ControlsSurface controls shall regulate the temperature of the blown air.Physical InspectionMTR 3.16ControlsSurface control settings shall be adjustable.Physical InspectionMTR 3.17ControlsSurface controls shall have lockout switches that are inaccessible to the patient.Physical InspectionMTR 3.18ControlsSurface controls shall be illuminated and clearly visible to be read at a distance of 10 feet. Physical InspectionMTR 3.19FeaturesSurface shall have a cardiopulmonary resuscitation (CPR) control function that quickly (i.e., a period of time of no more than 10 seconds) adjusts the bed to a flat and hard/stable position for the administration of CPR in the event of an emergency. Physical InspectionMTR 3.20FeaturesCPR function/quick release is clearly marked and is not power dependent. Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Standard)MTR #Method of EvaluationMTR 3.21FeaturesCPR function shall be accessible without moving the patient, side or end rails, or any other accessory or component attached to the surface.Physical InspectionMTR 3.22FeaturesCPR function shall be easily engaged using only one hand in a single motion.Physical InspectionMTR 3.23FeaturesSurface interior and exterior shall be free of toxins, including: cadmium, mercury, asbestos, PVC/DEHP, PCB, and CFC. Literature ReviewMTR 3.24FeaturesSurface shall not be made with natural rubber latex. Literature ReviewMTR 3.25FeaturesSurface shall not inhibit or restrict the ability to raise and lower the side rails of the bed frame. Physical InspectionMTR 3.26FeaturesSurface shall secure to the bed frame with straps, or equivalent feature, to prevent slipping. Physical InspectionMTR 3.27FeaturesSurface temperature of the blown air shall not exceed 105°F. Physical InspectionMTR 3.28FeaturesSurface shall have an input air filter. Literature Review and Physical InspectionMTR 3.29FeaturesSurface shall be fully inflated in thirty (30) seconds or less.Physical InspectionMTR 3.30FeaturesSurface shall utilize 100-150 liters of air per minute to maintain normal skin temperature and moisture levels.Literature Review MTR 3.31FeaturesSurface shall redistribute weight uniformly, reduce pressure to that of below capillary closure, and circulate air across the skin to reduce moisture.Literature Review MTR 3.32FeaturesSurface shall contain foam, or another equivalent pressure reducing product, at the base (beneath the cells) that allows some continuation of pressure reduction in the event of an extended mechanical or electrical failure.Literature Review and Physical InspectionMTR 3.33FeaturesSurface operational noise levels shall not exceed 35dB. Literature Review and Physical InspectionMTR 3.34FeaturesSurface, when bed is placed in Fowlers/Sitting position, cells shall not loose functionality and integrityPhysical InspectionMTR 3.35FeaturesSurface, when inflated, cells shall prevent 'bottoming out'. Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Standard)MTR #Method of EvaluationMTR 3.36FeaturesSurface shall have 'bolsters' to assist with transfers/getting out of bed, but also to prevent patient from 'rolling out' due to softness.Physical InspectionMTR 3.37FeaturesSurface pressure at heel area shall be less than at head area.Literature ReviewMTR 3.38FeaturesSurface shall remain inflated for 12 hours without power.Literature Review and Physical InspectionMTR 3.39FeaturesSurface shall Alarm to alert hospital staff when the system is not functioning within the manufactures' published specifications (e.g., power loss, air temperature too high, pressure level too low, etc.).Literature Review and Physical InspectionMTR 3.40FeaturesSurface shall have battery backup (or some other feature) to allow for continuous functioning of the surface during transport and power outages. Physical InspectionMTR 3.41FeaturesSurface shall have the capability of position adjustment in the event of a power failure.Physical InspectionMTR 3.42CleaningSurface must be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature Review MTR 3.43CleaningBed shall be able to be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature ReviewMTR 3.44Standards/ RegulationsBed shall meet ANSI/AAMI/IEC 60601-2:2007/(R) 2012, or equivalent electrical safety standard, that applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems.Literature ReviewMTR 3.45Standards/ RegulationsSurface shall meet the standards for the flammability of mattress sets (i.e., 16 CFR Part 1633, 16 CFR Part 1632). Literature ReviewLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Standard)MTR #Method of EvaluationMTR 3.46Standards/ RegulationsSurface shall be labeled in accordance with U.S. Food and Drug Administration’s (FDA’s) guidance for Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex issued on December 2, 2014. Literature Review MTR 3.47Standards/ RegulationsMedical device manufacturer shall be a registered establishment with the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Establishment Name and Registration Number. Literature Review and Government Database SearchMTR 3.48Standards/ RegulationsMedical device shall be listed with U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Proprietary Device Name. Literature Review and Government Database SearchMTR 3.49Standards/ RegulationsMedical device shall be classified by U.S. Food and Drug Administration (FDA) under non-powered flotation therapy mattress in accordance with 21 CFR § 880.5150. Provide Classification Name and Product Code. Literature Review and Government Database SearchBariatric Bed Systems (Includes Bariatric Hospital Bed, Low Air Loss/Alternating Pressure and Foam DEFINITIONAn AC-powered adjustable hospital bed is a device intended for medical purposes that consist of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails as well as surfaces (i.e., mattresses). INTENDED USEGeneral-purpose AC-powered adjustable hospital beds are used for an adult patient on an inpatient hospital and/or extended care unit for resting and sleeping, and also during recuperation and/or medical treatments (e.g., alternating pressure).General-Purpose AC-Powered Adjustable Hospital Bed Frame (Bariatric)MTR #Method of EvaluationMTR 4.1GeneralBed shall accept a variety of surfaces (i.e., mattresses) that reduce pressure, shear, friction and moisture.Literature Review and Physical InspectionMTR 4.2GeneralA list of all compatible surfaces (i.e., mattresses) shall be provided that includes: manufacturer, model, mattress type, dimensions (i.e., length, width, and height), and patient weight capacity.Literature ReviewGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Bariatric)MTR #Method of EvaluationMTR 4.3GeneralBed frame with a compatible surface (i.e., mattress) shall meet U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, issued on March 10, 2006, which includes the following dimensional limits: Zone 1 (within the rail) less than 120mm; Zone 2 (under the rail, between rail supports or next to a single rail support) less than 120mm; Zone 3 (between rail and mattress) less than 120mm; Zone 4 (under the rail at the ends of the rail) less than 60mm AND greater than 60° angle.Physical InspectionMTR 4.4GeneralBed frame with a compatible surface (i.e., mattress) shall meet the IEC/EN 60601-2-52 bed standard, which includes the following additional dimensional limits: Zone 5 (between split bed rails) less than 120 mm or greater than 318 mm; Zone 6 (between the end of the rail and the side edge of the head or foot board) less than 120 mm; Zone 7 (between the head or foot board and the mattress end) less than 120 mm. Physical InspectionMTR 4.5General Bed deck shall not contain springs.Physical InspectionMTR 4.6DimensionsBed length shall be no less than 80 inches.Physical InspectionMTR 4.7DimensionsBed length shall be electronically adjustable to an additional 12 inches (± 2 inches) without use of tools or additional parts.Physical InspectionMTR 4.8DimensionsBed width shall be no less than 39 inches, expandable and retractablePhysical InspectionMTR 4.9DimensionsBed shall have a fully motorized general-purpose electric bed frame capable of adjusting bed height and surface position. Bed shall descend to a minimum height of 20 inches and rise to a height of 33 inches. Literature Review and Physical InspectionMTR 4.10WeightBed shall support a patient weight of 800 pounds. Literature Review MTR 4.11WeightBed shall be prominently labeled to identify maximum patient weight capacity.Physical InspectionMTR 4.12RailsEnd rails (i.e., headboard and footboard) shall be removable without the use of tools.Physical InspectionGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Bariatric)MTR #Method of EvaluationMTR 4.13RailsSide rails shall be attached to the bed frame. Physical InspectionMTR 4.14RailsSide rails shall be single hand release and able to be manually raised and lowered, and may be full length, half-length or quarter length.Physical InspectionMTR 4.15ControlsBed shall have separate controls for the patient and the hospital staff (e.g., nurse or caregiver). Literature Review and Physical InspectionMTR 4.16ControlsBed controls shall be integrated into the side rail(s) or contained within a separate hand pendant and are identified with words or symbols.Physical InspectionMTR 4.17ControlsBed controls shall be sealed against fluid penetration. Literature Review and Physical InspectionMTR 4.18ControlsBed controls shall be of the momentary-contact type.Physical InspectionMTR 4.19ControlsBed controls shall NOT be of the walk-away type. Physical InspectionMTR 4.20ControlsBed controls shall include controls for patient lockout and special bed positions (e.g., Trendelenburg, Reverse Trendelenburg, Chair). Physical InspectionMTR 4.21ControlsCaregiver bed controls shall have lockout switches that are inaccessible to the patient and disable the patient bed controls. Physical InspectionMTR 4.22ControlsBed controls shall be illuminated and identified with clearly visible symbols that allows for ease of use.Physical InspectionMTR 4.23FeaturesBed shall have a cardiopulmonary resuscitation (CPR) control function that within 10 seconds (i.e., a period of time of no more than 10 seconds) adjusts the bed to a flat and stable position for the administration of CPR in the event of an emergency. Physical InspectionMTR 4.24FeaturesCPR function/quick release is clearly marked, at the head of the bed, on the right and left sides and is not power dependent. Physical InspectionGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Bariatric)MTR #Method of EvaluationMTR 4.25FeaturesCPR function shall be accessible without moving the patient, side or end rails, or any other accessory or component attached to the bed frame.Physical InspectionMTR 4.26FeaturesCPR function shall be easily engaged using only one hand in a single motion.Physical InspectionMTR 4.27FeaturesBed shall have an exit-alarm feature.Literature Review and Physical InspectionMTR 4.28FeaturesBed Exit Alarms shall only be able to be engaged and disengaged by staff; patient shall not have accessibility. Literature Review and Physical InspectionMTR 4.29FeaturesBed Exit Alarms shall have an audible alarm and can be integrated into a hospital communication/call system in which the alarm will sound via the call system at a central station and a call light will illuminate over the patient room door.Literature Review and Physical InspectionMTR 4.30FeaturesNurse Call feature shall be clearly visible with symbols and/or text, and easily accessible to the patient.Physical InspectionMTR 4.31FeaturesNurse Call feature shall be integrated into the side rails and contained in a separate hand held pendant. Physical InspectionMTR 4.32FeaturesBed shall have an automatic contour feature (also referred to as auto contour and automatic knee break) that simultaneously bends the knee section of the bed when the head section is raised. Physical InspectionMTR 4.33FeaturesBed shall be retractable such that the foot end moves toward the head of the bed when the head section is raised.Physical InspectionMTR 4.34FeaturesBed shall have a 'Power Drive System' feature for ease in transporting and is not dependent on AC power.Physical InspectionMTR 4.35FeaturesBed shall allow for transportation in an elevated position.Physical InspectionMTR 4.36FeaturesBed shall have a central brake system that is engaged and disengaged by foot control.Physical InspectionGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Bariatric)MTR #Method of EvaluationMTR 4.37FeaturesBed shall be capable of special bed positions, such as the chair /cardiac chair position or Trendelenburg/Reverse Trendelenburg.Physical InspectionMTR 4.38FeaturesChanges in bed positions shall be conducted using electrical controls (i.e., head of bed and foot of bed are raised or lowered via use of bed controls).Physical InspectionMTR 4.39FeaturesBed shall allow lifts and other equipment beneath the bed deck. Physical InspectionMTR 4.40FeaturesBed shall have at least two (2) IV Pole Holders. Physical InspectionMTR 4.41FeaturesBed shall support attachment of traction equipment. Literature ReviewMTR 4.42FeaturesBed shall have the capability of position adjustment in the event of a power failure. Physical InspectionMTR 4.43CleaningBed shall be able to be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature ReviewMTR 4.44Standards/RegulationsBed shall meet ANSI/AAMI/IEC 60601-2:2007/(R) 2012, or equivalent electrical safety standard, that applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems.Literature ReviewMTR 4.45Standards/RegulationsMedical device manufacturer shall be a registered establishment with the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Establishment Name and Registration Number. Literature Review and Government Database SearchGeneral-Purpose AC-Powered Adjustable Hospital Bed Frame (Bariatric)MTR #Method of EvaluationMTR 4.46Standards/RegulationsMedical device shall be listed with U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Proprietary Device Name. Literature Review and Government Database SearchMTR 4.47Standards/RegulationsMedical device shall be classified by U.S. Food and Drug Administration (FDA) under AC-powered Adjustable Hospital Bed in accordance with 21 CFR § 880.5100. Provide Classification Name and Product Code. Literature Review and Government Database SearchNon-Powered, Pressure Reduction, Foam Mattress (Bariatric)MTR #Method of EvaluationMTR 5.1GeneralSurface must be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature ReviewMTR 5.2GeneralSurface shall reduce friction and shear.Literature ReviewMTR 5.3GeneralA list of all compatible bed frames shall be provided that includes: manufacturer, model, mattress type, dimensions (i.e., length, width, and height), and patient weight capacity.Literature ReviewMTR 5.4GeneralSurface (i.e., mattress) with a compatible bedframe shall meet U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, issued on March 10, 2006, which includes the following dimensional limits: Zone 1 (within the rail) less than 120mm; Zone 2 (under the rail, between rail supports or next to a single rail support) less than 120mm; Zone 3 (between rail and mattress) less than 120mm; Zone 4 (under the rail at the ends of the rail) less than 60mm AND greater than 60° angle.Physical InspectionNon-Powered, Pressure Reduction, Foam Mattress (Bariatric)MTR #Method of EvaluationMTR 5.5GeneralSurface (i.e., mattress) with a compatible bedframe shall meet the IEC/EN 60601-2-52 bed standard, which includes the following additional dimensional limits: Zone 5 (between split bed rails) less than 120 mm or greater than 318 mm; Zone 6 (between the end of the rail and the side edge of the head or foot board) less than 120 mm; Zone 7 (between the head or foot board and the mattress end) less than 120 mm. Physical InspectionMTR 5.6DimensionsSurface length shall be 80 inches (+/- 1 inch). Physical InspectionMTR 5.7DimensionsSurface width shall be 39 inches (+/- 1 inch). Physical InspectionMTR 5.8WeightSurface shall support a patient weight of 800 pounds. Literature Review MTR 5.9WeightSurface shall be prominently labeled to identify maximum patient weight capacity. Physical InspectionMTR 5.10CoverSurface cover shall be bacteria resistant, flame retardant, fluid impenetrable, anti-fungal, anti-static, non-allergenic and non-shearing.Literature ReviewMTR 5.11CoverSurface cover shall be vinyl and/or nylon.Literature ReviewMTR 5.12FeaturesSurface interior and exterior shall be free of toxins, including: cadmium, mercury, asbestos, PVC/DEHP, PCB, and CFC. Literature Review MTR 5.13FeaturesSurface shall not be made with natural rubber latex. Literature ReviewMTR 5.14FeaturesSurface shall be multi-zoned (i.e., a mattress that has different segments that have different pressure distribution characteristics to help reduce the development of bed sores in areas where they are most likely to develop, such as the head, body and foot) to match the body’s proportional differences maximizing pressure redistribution to the head, body and foot. Physical InspectionMTR 5.15FeaturesSurface shall not inhibit or restrict the ability to raise and lower the side rails of the bed frame. Physical InspectionNon-Powered, Pressure Reduction, Foam Mattress (Bariatric)MTR #Method of EvaluationMTR 5.16FeaturesSurface shall be compatible with bed exit alarms so as not to compromise alarm function.Literature ReviewMTR 5.17FeaturesSurface shall contain non-powered air support chambers or cylinders, which can be manually adjusted via use of a pump, but are not dependent upon power to maintain pressure reduction. Physical InspectionMTR 5.18FeaturesSurface shall secure to the bed frame (e.g. magnets/Velcro, anti-skid bottom) so that surface does not slip/slide or migrate when bed is placed in fowlers or Trendelenburg positions. Physical InspectionMTR 5.19CleaningSurface must be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature ReviewMTR 5.20Standards/RegulationsSurface shall meet all State and Federal safety standards which includes fire regulations. Literature ReviewMTR 5.21Standards/RegulationsSurface shall meet the standards for the flammability of mattress sets (i.e., 16 CFR Part 1633, 16 CFR Part 1632). Literature Review MTR 5.22Standards/RegulationsSurface shall be labeled in accordance with U.S. Food and Drug Administration’s (FDA’s) guidance for Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex issued on December 2, 2014. Literature Review MTR 5.23Standards/RegulationsMedical device manufacturer shall be a registered establishment with the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Establishment Name and Registration Number. Literature Review and Government Database SearchNon-Powered, Pressure Reduction, Foam Mattress (Bariatric)MTR #Method of EvaluationMTR 5.24Standards/RegulationsMedical device shall be listed with U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Proprietary Device Name. Literature Review and Government Database SearchMTR 5.25Standards/RegulationsMedical device shall be classified by U.S. Food and Drug Administration (FDA) under non-powered flotation therapy mattress in accordance with 21 CFR § 880.5150. Provide Classification Name and Product Code. Literature Review and Government Database SearchLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Bariatric)MTR #Method of EvaluationMTR 6.1GeneralSurface shall consist of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. Literature ReviewMTR 6.2GeneralSurface shall reduce friction and shear.Literature ReviewMTR 6.3GeneralA list of all compatible bed frames shall be provided that includes: manufacturer, model, mattress type, dimensions (i.e., length, width, and height), and patient weight capacity.Literature ReviewMTR 6.4GeneralSurface (i.e., mattress) with a compatible bedframe shall meet U.S. Food and Drug Administration’s (FDA’s) Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, issued on March 10, 2006, which includes the following dimensional limits: Zone 1 (within the rail) less than 120mm; Zone 2 (under the rail, between rail supports or next to a single rail support) less than 120mm; Zone 3 (between rail and mattress) less than 120mm; Zone 4 (under the rail at the ends of the rail) less than 60mm AND greater than 60° angle.Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Bariatric)MTR #Method of EvaluationMTR 6.5GeneralSurface (i.e., mattress) with a compatible bedframe shall meet the IEC/EN 60601-2-52 bed standard, which includes the following additional dimensional limits: Zone 5 (between split bed rails) less than 120 mm or greater than 318 mm; Zone 6 (between the end of the rail and the side edge of the head or foot board) less than 120 mm; Zone 7 (between the head or foot board and the mattress end) less than 120 mm. Physical InspectionMTR 6.6DimensionsSurface length shall be 80 inches (+/- 1 inch).Physical InspectionMTR 6.7DimensionsSurface width shall be 39 inches (+/- 1 inch). Physical InspectionMTR 6.8DimensionsSurface height when fully inflated shall be no less than 5 inches.Physical InspectionMTR 6.9DimensionsSurface height when fully inflated shall not exceed 10 inches and not raise equal to or exceed the height of the side rails.Physical InspectionMTR 6.10WeightSurface shall support a patient weight of 800 pounds. Literature Review MTR 6.11WeightSurface shall be prominently labeled to identify maximum patient weight capacity. Physical InspectionMTR 6.12CoverSurface cover shall be bacteria resistant, flame retardant, fluid impenetrable, anti-fungal, anti-static, non-allergenic and non-shearing.Literature Review MTR 6.13CoverSurface cover shall be vinyl and/or nylon.Literature Review MTR 6.14ControlsSurface controls shall be on the front panel of the bed and secured on bed frame. Physical InspectionMTR 6.15ControlsSurface controls shall regulate the temperature of the blown air.Physical InspectionMTR 6.16ControlsSurface control settings shall be adjustable.Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Bariatric)MTR #Method of EvaluationMTR 6.17ControlsSurface controls shall have lockout switches that are inaccessible to the patient.Physical InspectionMTR 6.18ControlsSurface controls shall be illuminated and clearly visible to be read at a distance of 10 feet. Physical InspectionMTR 6.19FeaturesSurface shall have a cardiopulmonary resuscitation (CPR) control function that quickly (i.e., a period of time of no more than 10 seconds) adjusts the bed to a flat and hard/stable position for the administration of CPR in the event of an emergency. Physical InspectionMTR 6.20FeaturesCPR function/quick release is clearly marked and is not power dependent. Physical InspectionMTR 6.21FeaturesCPR function shall be accessible without moving the patient, side or end rails, or any other accessory or component attached to the surface.Physical InspectionMTR 6.22FeaturesCPR function shall be easily engaged using only one hand in a single motion.Physical InspectionMTR 6.23FeaturesSurface interior and exterior shall be free of toxins, including: cadmium, mercury, asbestos, PVC/DEHP, PCB, and CFC. Literature ReviewMTR 6.24FeaturesSurface shall not be made with natural rubber latex. Literature ReviewMTR 6.25FeaturesSurface shall not inhibit or restrict the ability to raise and lower the side rails of the bed frame. Physical InspectionMTR 6.26FeaturesSurface shall secure to the bed frame with straps, or equivalent feature, to prevent slipping. Physical InspectionMTR 6.27FeaturesSurface temperature of the blown air shall not exceed 105°F. Physical InspectionMTR 6.28FeaturesSurface shall have an input air filter. Literature Review and Physical InspectionMTR 6.29FeaturesSurface shall be fully inflated in thirty 30) seconds or less.Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Bariatric)MTR #Method of EvaluationMTR 6.30FeaturesSurface shall utilize 100-150 liters of air per minute to maintain normal skin temperature and moisture levels.Literature ReviewMTR 6.31FeaturesSurface shall redistribute weight uniformly, reduce pressure to that of below capillary closure, and circulate air across the skin to reduce moisture.Literature Review MTR 6.32FeaturesSurface shall contain foam, or another equivalent pressure reducing product, at the base (beneath the cells) that allows some continuation of pressure reduction in the event of an extended mechanical or electrical failure.Literature Review and Physical InspectionMTR 6.33FeaturesSurface operational noise levels shall not exceed 35dB. Literature Review and Physical InspectionMTR 6.34FeaturesSurface, when bed is placed in Fowlers/Sitting position, cells shall not loose functionality and integrityPhysical InspectionMTR 6.35FeaturesSurface, when inflated, cells shall prevent 'bottoming out'. Physical InspectionMTR 6.36FeaturesSurface shall have 'bolsters' to assist with transfers/getting out of bed, but also to prevent patient from 'rolling out' due to softness.Physical InspectionMTR 6.37FeaturesSurface pressure at heel area shall be less than at head area.Literature ReviewMTR 6.38FeaturesSurface shall remain inflated for 12 hours without power.Literature Review and Physical InspectionMTR 6.39FeaturesSurface shall Alarm to alert hospital staff when the system is not functioning within the manufactures' published specifications (e.g., power loss, air temperature too high, pressure level too low, etc.).Literature Review and Physical InspectionMTR 6.40FeaturesSurface shall have battery backup (or some other feature) to allow for continuous functioning of the surface during transport and power outages. Physical InspectionMTR 6.41FeaturesSurface shall have the capability of position adjustment in the event of a power failure.Physical InspectionLow-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Bariatric)MTR #Method of EvaluationMTR 6.42CleaningSurface must be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature Review MTR 6.43CleaningBed shall be able to be cleaned and disinfected using Environmental Protection Agency (EPA) approved and Environmental Programs Service (EPS) standardized cleaning & disinfectant chemicals.? No manufacturer will require the VA to procure specialty cleaning and/or specialty disinfecting chemicals other than the EPS standardized products as a prerequisite to avoid breaching the warranty for the specific RME.Literature ReviewMTR 6.44Standards/RegulationsBed shall meet ANSI/AAMI/IEC 60601-2:2007/(R) 2012, or equivalent electrical safety standard, that applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems.Literature ReviewMTR 6.45Standards/RegulationsSurface shall meet the standards for the flammability of mattress sets (i.e., 16 CFR Part 1633, 16 CFR Part 1632). Literature ReviewMTR 6.46Standards/RegulationsSurface shall be labeled in accordance with U.S. Food and Drug Administration’s (FDA’s) guidance for Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex issued on December 2, 2014. Literature Review Low-Air-Loss, Alternating Pressure, AC-Powered Adjustable Hospital Mattress (Bariatric)MTR #Method of EvaluationMTR 6.47Standards/RegulationsMedical device manufacturer shall be a registered establishment with the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Establishment Name and Registration Number. Literature Review and Government Database SearchMTR 6.48Standards/RegulationsMedical device shall be listed with U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 807. Provide Proprietary Device Name. Literature Review and Government Database SearchMTR 6.49Standards/RegulationsMedical device shall be classified by U.S. Food and Drug Administration (FDA) under non-powered flotation therapy mattress in accordance with 21 CFR § 880.5150. Provide Classification Name and Product Code. Literature Review and Government Database Search ................
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