ATTACHMENT C - MINIMUM TECHNICAL REQUIREMENTS.docx

ATTACHMENT D

MINIMUM TECHNICAL REQUIREMENTS

1. AUTO-TITRATING CONTINUOUS POSITIVE AIRWAY PRESSURE (APAP) MACHINE (CLIN 0001):

Provide documentation (certificate or equivalent) that products meet the requirements of the International Organization for Standardization (ISO) 80601-2-70:2015: Medical Electrical Equipment-Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.

Provide documentation (certificate or equivalent) that products meet the requirements of the ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.

Provide documentation (certificate or equivalent) that products meet United States FDA 510K Standard.

Provide documentation (certificate or equivalent) that products meet Radio Technical Commission for Aeronautics/ Environmental Conditions and Test Procedures for Airborne Equipment (RTCA/DO-160G) section 21, category M, Emission of Radio Frequency Energy.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1-2:2014 Electromagnetic Compatibility and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

General Device Specifications:

Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.

The device serial number shall be visible on the outside of the box.

A power cord and operating instructions brochure must be supplied with the device.

All APAP machines must have integrated humidifier.

APAP machine (with empty humidifier) must weigh 7lbs or less.

Offerors must provide documentation that demonstrates that they have tested each CPAP device submitted for noise volume in dB while at 10 cm H2O pressures. Testing must be done in accordance with the ISO 80601-2-70:2015 and must be below 40 dB at 10 cm H2O pressures.

Machine must accept and work properly with facial interfaces from at least three different manufacturers.

Machines must have a carrying case that accommodates the machine, facial interface, and tubing.

Machine must be able to use standard size tubing: Length 6-12 feet, diameter dependent on PAP machine requirements (i.e. 15mm, 22mm or as required by the specific machine, with a female connector) Machine must accommodate tubing with heating coil.

Operating Instructions: Must be provided in the English language both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.

Operational Modes: There must be two modes of operation:

Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.

User Mode - enables a limited range of comfort settings to be made and adjusted by the user.

Prescribed Parameter Set-Up: Must be possible through ALL the following methods.

Directly from operation keys on the APAP device Remotely using PC/Mac software via USB drive/data card application Remotely using secure wireless, cloud-based technology APAP Parameter Settings:

Machines must have selectable pressure between an inclusive lower pressure of 4 and an inclusive upper pressure of at least 20 cmH20 in increments of 1 cmH20 or less.

Airflow must keep the facial interface pressurized with a positive pressure needed to maintain airway patency.

Machines must have continuous PAP (CPAP) capability in addition to APAP capability.

Machine auto-adjustment must be based on airflow limitation.

The high and low-pressure range boundaries must be settable independently by the prescriber and PAP technicians.

Machines must have “ramp” capability that allows positive pressure to gradually increase over time (maximum pressure increments 2 cm H2O, total ramp time must be adjustable between 0 and 45 minutes or more).

Data Parameters, Access, and Storage:

Wireless data transmission must be available on every APAP machine with a secure Cloud based platform that allows provider management of sleep apnea patients.

Machine must store a minimum of 90 days of "time-on-mask" usage data, downloadable using a memory-chip/device OR secure wireless, cloud-based transmission.

Usage data must include “time-on-mask,” pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).

All data must be made available in structured variable form with HL-7 capability.

Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.

Memory chip readers, associated software, and updates to that software must be made available to facilities.

A secure digital (SD) card or Universal Serial Bus (USB) must be supplied with each device. The SD card/USB device should be specific for use in the associated machine (no generic SD cards/USB devices will be allowed). It also must be available for purchase as a replacement item for lost/damaged SD cards/USB device.

Capacity of 2GB or more to store 90 days of “time on mask” usage data.

Full Size SD/USB (sized to fit the specific manufacturer’s devices) Class 6 or higher (SD card) Conform to IEC 60601-1 requirements.

Maintenance, Cleaning, and Infection Control:

APAP units must be able to be cleaned and disinfected with commercially available household cleaning agents.

It must be possible to completely dismantle the water chamber and disinfect all parts.

Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.

The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.

Documentation must be provided with each machine and to the VA facility that specifies the manufacturer’s recommendations for routine servicing (including recommended resources for maintenance/ servicing).

Power Supply Specifications:

The APAP device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.

Steady-state (“typical”) power consumption without humidifier on 120 V AC power must be ≤75 watts. Maximum power consumption with humidifier on 120 V AC power must be ≤100 watts.

Machine must have double insulated, 2-prong AC plugs for home use. Three prongs are not acceptable.

The power supply unit and power cord must be available for purchase for replacement of lost or damaged power supply and/or power cord. A separate DC adapter may be available for purchase; this optional item is preferred.

Humidifier Specifications:

When used with heated humidification, the device must provide water ingress protection if tilted 90 degrees in any direction.

Machine must have a humidifier that can be used in both heated and unheated mode.

The patient must be able to adjust humidifier settings.

When the APAP machine is used with humidification, it must be compatible with at least 2 types of tubing manufactured by companies other than the manufacturer, unless utilizing heated-wire circuits.

Humidifier water chamber must be available for purchase as a replacement item for a lost/damaged humidifier water chamber.

Indication of Fault Conditions:

The device must indicate conditions which the user can rectify via the device display.

For all other fault conditions which require expert or manufacturer intervention, the device must indicate via the device display that a fault exists to the user, give a fault code, and advise the user to refer to the provider/manufacturer.

Assembly: APAP machines must leave the manufacturer fully assembled, complete with attachable humidifier. They must be shipped as individual units in standard commercial configuration.

Each PAP device offered and supplied under the contract (s) shall include typical items customarily included with new sales to the general public, and at a minimum include, Case, Tubing, Filters, Power Cord, SD Cards, Instructions.

Warranty: All APAP machines shall be covered by at least a standard commercial warranty of a minimum of two (2) years, with five (5) years preferred, for the device, and 90 days on any accessories. If the manufacturer/vendor standard warranty exceeds the specified warranty, the manufacturer’s/vendor’s standard warranty will apply for all associated parts including humidifier, power supply, and APAP generator.

2. ADAPTIVE SERVO-VENTILATION (ASV) MACHINE (CLIN 0002):

1. Provide documentation (certificate or equivalent) that products meet the requirements of the International Organization for Standardization (ISO) 80601-2-70:2015: Medical Electrical Equipment-Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.

Provide documentation (certificate or equivalent) that products meet the requirements of the ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.

Provide documentation (certificate or equivalent) that products meet United States FDA 510K Standard.

Provide documentation (certificate or equivalent) that products meet Radio Technical Commission for Aeronautics/ Environmental Conditions and Test Procedures for Airborne Equipment (RTCA/DO-160G) section 21, category M, Emission of Radio Frequency Energy.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1-2:2014 Electromagnetic Compatibility and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

General Device Specifications:

Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.

The device serial number shall be visible on the outside of the box.

A power cord and operating instructions brochure must be supplied with the device.

All ASV machines must have integrated humidifier.

ASV machine (with empty humidifier) must weigh 7lbs or less.

Offerors must provide documentation that demonstrates that they have tested each PAP device submitted for noise volume in dB while at 10 cm H2O pressures. Testing must be done in accordance with the ISO 80601-2-70:2015 and must be below 40 dB at 10 cm H2O pressures.

Machine must accept and work properly with facial interfaces from at least three different manufacturers.

Machines must have a carrying case that accommodates the machine, facial interface, and tubing.

Machine must be able to use standard size tubing: Length 6-12 feet, diameter dependent on PAP machine (i.e. 15mm, 22mm or as required by the specific machine, with a female connector).

Machine must accommodate tubing with heating coil.

Operating Instructions: Must be provided in the English language for both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.

Operational Modes: There must be two modes of operation:

Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.

User Mode - enables a limited range of comfort settings to be made and adjusted by the user.

Prescribed Parameter Set-Up: Must be possible through ALL the following methods.

Directly from operation keys on the ASV device Remotely using PC/Mac software via USB drive/data card application Remotely using secure wireless, cloud-based technology ASV Parameter Settings:

Airflow must keep the facial interface pressurized with a positive pressure needed to maintain airway patency.

Machine auto-adjustment must be based on airflow limitation.

The high and low-pressure range boundaries must be settable independently by the prescriber and PAP technician.

ASV machine inspiratory and expiratory pressures must be independently adjustable.

Data Parameters, Access, and Storage:

Wireless data transmission must be available on every ASV machine with a secure Cloud based platform that allows provider management of sleep apnea patients.

Machine must store a minimum of 90 days of "time-on-mask" usage data downloadable using a memory-chip AND secure wireless, cloud-based transmission.

Usage data must include “time-on-mask,” pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).

All data must be made available in structured variable form with HL-7 capability.

Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.

Memory chip readers, associated software, and updates to that software must be made available to facilities.

A secure digital (SD) card or Universal Serial Bus (USB) must be supplied with each device. The SD card/USB device should be specific for use in the associated machine (no generic SD cards/USB devices will be allowed). It also must be available for purchase as a replacement item for lost/damaged SD cards/USB device.

Capacity of 2GB or more to store 90 days of “time on mask” usage data.

Full Size SD/USB (sized to fit the specific manufacturer’s devices) Class 6 or higher (SD card) Conform to IEC 60601-1 requirements.

Maintenance, Cleaning, and Infection Control:

ASV units must be able to be cleaned and disinfected with commercially available household cleaning agents.

It must be possible to completely dismantle the water chamber and disinfect all parts.

Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.

The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.

Documentation must be provided with each machine and to the VA facility that specifies the manufacturer’s recommendations for routine servicing (including recommended resources for maintenance/ servicing).

Power Supply Specifications:

The ASV device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.

Steady-state (“typical”) power consumption without humidifier on 120 V AC power must be ≤75 watts. Maximum power consumption with humidifier on 120 V AC power must be ≤100 watts.

Machine must have double insulated, 2-prong AC plugs for home use. Three prongs are not acceptable.

The power supply unit and power cord must be available for purchase for replacement of lost or damaged power supply and/or power cord. A separate DC adapter may be available for purchase; this optional item is preferred.

Humidifier Specifications:

When used with heated humidification, the device must provide water ingress protection if tilted 90 degrees in any direction.

Machine must have a humidifier that can be used in both heated and unheated mode.

The patient must be able to adjust humidifier settings.

When the ASV machine is used with humidification, it must be compatible with at least 2 types of tubing manufactured by companies other than the manufacturer, unless using a heated-wire tubing.

Humidifier water chamber must be available for purchase as a replacement item for a lost/damaged humidifier water chamber.

Indication of Fault Conditions:

The device must indicate conditions which the user can rectify via the device display.

For all other fault conditions which require expert or manufacturer intervention, the device must indicate via the device display that a fault exists to the user, give a fault code, and advise the user to refer to the provider/manufacturer.

Assembly: ASV machines must leave the manufacturer fully assembled, complete with attachable humidifier. They must be shipped as individual units in standard commercial configuration.

Each PAP device offered and supplied under the contract (s) shall include typical items customarily included with new sales to the general public, and at a minimum include, Case, Tubing, Filters, Power Cord, SD Cards, Instructions.

Warranty: All ASV machines shall be covered by at least a standard commercial warranty of a minimum of two (2) years, with five (5) years preferred, for the device, and 90 days on any accessories. If the manufacturer/vendor standard warranty exceeds the specified warranty, the manufacturer’s/vendor’s standard warranty will apply for all associated parts including humidifier, power supply, and ASV generator.

3. AUTO-TITRATING BILEVEL POSITIVE AIRWAY PRESSURE (BPAP) MACHINES (CLIN 0003A)

1. Provide documentation (certificate or equivalent) that products meet the requirements of the International Organization for Standardization (ISO) 80601-2-70:2015: Medical Electrical Equipment-Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.

Provide documentation (certificate or equivalent) that products meet the requirements of the ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.

Provide documentation (certificate or equivalent) that products meet United States FDA 510K Standard.

Provide documentation (certificate or equivalent) that products meet Radio Technical Commission for Aeronautics/ Environmental Conditions and Test Procedures for Airborne Equipment (RTCA/DO-160G) section 21, category M, Emission of Radio Frequency Energy.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1-2:2014 Electromagnetic Compatibility and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

General Device Specifications:

Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.

The device serial number shall be visible on the outside of the box.

A power cord and operating instructions brochure must be supplied with the device.

All BPAP machines must have integrated humidifier.

BPAP machine (with empty humidifier) must weigh 7lbs or less.

Offerors must provide documentation that demonstrates that they have tested each PAP device submitted for noise volume in dB while at 10 cm H2O pressures. Testing must be done in accordance with the ISO 80601-2-70:2015 and must be below 40 dB at 10 cm H2O pressures.

Machine must accept and work properly with facial interfaces from at least three different manufacturers.

Machines must have a carrying case that accommodates the machine, facial interface, and tubing.

Machine must be able to use standard size tubing: Length 6-12 feet, diameter dependent on PAP machine requirements (i.e. 15mm, 22mm or as required by the specific machine, with a female connector).

Machine must accommodate tubing with heating coil.

Operating Instructions: Must be provided in the English language for both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.

Operational Modes: There must be two modes of operation as detailed below:

Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.

User Mode - enables a limited range of comfort settings to be made and adjusted by the user.

Prescribed Parameter Set-Up: Must be possible through ALL of the following methods.

Directly from operation keys on the BPAP device Remotely using PC/Mac software via USB drive/data card application Remotely using secure wireless, cloud-based technology BPAP Parameter Settings:

BPAP machine inspiratory and expiratory pressures must be independently adjustable.

BPAP inspiratory and expiratory time periods must be independently adjustable.

Machines must have a selectable expiratory pressure range between an inclusive lower pressure of 5 and an inclusive upper pressure of at least 20 cm H20 in increments of 1cm H20 or less.

Machines must have a selectable inspiratory pressure range between an inclusive lower pressure of 5 and an inclusive upper pressure of at least 25 cm H20 in increments of 1cm H20 or less.

Airflow must keep the facial interface pressurized with a positive pressure needed to maintain airway patency.

Machines must have fixed BPAP capability in addition to autoBPAP functionality.

Machine auto-adjustment must be based on airflow limitation.

Data Parameters, Access, and Storage:

Wireless data transmission must be available on every APAP machine with a secure Cloud based platform that allows provider management of sleep apnea patients.

Machine must store a minimum of 90 days of "time-on-mask" usage data downloadable using a memory-chip AND secure wireless, cloud-based transmission.

Usage data must include “time-on-mask,” pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).

Usage date must be made available in structured variable form with HL-7 capability.

Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.

Memory chip readers, associated software, and updates to that software must be made available to facilities.

A secure digital (SD) card or Universal Serial Bus (USB) must be supplied with each device. The SD card/USB device should be specific for use in the associated machine (no generic SD cards/USB devices will be allowed). It also must be available for purchase as a replacement item for lost/damaged SD cards/USB device.

Capacity of 2GB or more to store 90 days of “time on mask” usage data.

Full Size SD/USB (sized to fit the specific manufacturer’s devices) Class 6 or higher (SD card) Conform to IEC 60601-1 requirements.

Maintenance, Cleaning, and Infection Control:

BPAP units must be able to be cleaned and disinfected with commercially available household cleaning agents.

It must be possible to completely dismantle the water chamber and disinfect all parts.

Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.

The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.

Documentation must be provided with each machine and to the VA facility that specifies the manufacturer’s recommendations for routine servicing (including recommended resources for maintenance/ servicing).

Power Supply Specifications:

The BPAP device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.

Steady-state (“typical”) power consumption without humidifier on 120 V AC power must be ≤75 watts. Maximum power consumption with humidifier on 120 V AC power must be ≤100 watts.

Machine must have double insulated, 2-prong AC plugs for home use. Three prongs are not acceptable.

The power supply unit and power cord must be available for purchase for replacement of lost or damaged power supply and/or power cord. A separate DC adapter may be available for purchase; this optional item is preferred.

Humidifier:

When used with heated humidification, the device must provide water ingress protection if tilted 90 degrees in any direction.

Machine must have a humidifier that can be used in both heated and unheated mode.

The patient must be able to adjust humidifier settings.

When the BPAP machine is used with humidification, it must be compatible with at least 2 types of tubing manufactured by companies other than the manufacturer, except those utilizing heated-wire circuits.

Humidifier water chamber must be available for purchase as a replacement item for a lost/damaged humidifier water chamber.

Indication of Fault Conditions:

The device must indicate conditions which the user can rectify via the device display.

For all other fault conditions which require expert or manufacturer intervention, the device must indicate via the device display that a fault exists to the user, give a fault code, and advise the user to refer to the provider/manufacturer.

Assembly: BPAP machines must leave the manufacturer fully assembled, complete with attachable humidifier. They must be shipped as individual units in standard commercial configuration.

Each PAP device offered and supplied under the contract (s) shall include typical items customarily included with new sales to the general public, and at a minimum include, Case, Tubing, Filters, Power Cord, SD Cards, Instructions.

Warranty: All BPAP machines shall be covered by at least a standard commercial warranty of a minimum of two (2) years, with five (5) years preferred, for the device, and 90 days on any accessories. If the manufacturer/vendor standard warranty exceeds the specified warranty, the manufacturer’s/vendor’s standard warranty will apply for all associated parts including humidifier, power supply, and BPAP generator.

4. BILEVEL POSITIVE AIRWAY PRESSURE (BPAP) MACHINES WITHOUT SPONTANEOUS-TIMED (S) CAPABILITIES (CLIN 0003B):

1. Provide documentation (certificate or equivalent) that products meet the requirements of the International Organization for Standardization (ISO) 80601-2-70:2015: Medical Electrical Equipment-Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.

Provide documentation (certificate or equivalent) that products meet the requirements of the ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.

Provide documentation (certificate or equivalent) that products meet United States FDA 510K Standard.

Provide documentation (certificate or equivalent) that products meet Radio Technical Commission for Aeronautics/ Environmental Conditions and Test Procedures for Airborne Equipment (RTCA/DO-160G) section 21, category M, Emission of Radio Frequency Energy.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1-2:2014 Electromagnetic Compatibility and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

General Device Specifications:

Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.

The device serial number shall be visible on the outside of the box.

A power cord and operating instructions brochure must be supplied with the device.

All BPAP machines must have integrated humidifier.

BPAP machine (with empty humidifier) must weigh 7lbs or less.

Offerors must provide documentation that demonstrates that they have tested each PAP device submitted for noise volume in dB while at 10 cm H2O pressures. Testing must be done in accordance with the ISO 80601-2-70:2015 and must be below 40 dB at 10 cm H2O pressure.

Machine must accept and work properly with facial interfaces from at least three different manufacturers.

Machines must have a carrying case that accommodates the machine, facial interface, and tubing.

Machine must be able to use standard size tubing Length 6-12 feet, diameter dependent on PAP machine requirements (i.e. 15mm, 22mm or as required by the specific machine, with a female connector).

Machine must accommodate tubing with heating coil.

Operating Instructions: Must be provided in the English language for both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.

Operational Modes: There must be two modes of operation as detailed below:

Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.

User Mode - enables a limited range of comfort settings to be made and adjusted by the user.

Prescribed Parameter Set-Up: Must be possible through ALL of the following methods.

Directly from operation keys on the BPAP device Remotely using PC/Mac software via USB drive/data card application Remotely using secure wireless, cloud-based technology BPAP Parameter Settings:

BPAP machine inspiratory and expiratory pressures must be independently adjustable.

BPAP inspiratory and expiratory time periods must be independently adjustable.

Data Parameters, Access, and Storage:

Wireless data transmission must be available on every BPAP machine with a secure Cloud based platform that allows provider management of sleep apnea patients.

Machine must store a minimum of 90 days of "time-on-mask" usage data downloadable using a memory-chip AND secure wireless, cloud-based transmission.

Usage data must include “time-on-mask,” pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).

Usage date must be made available in structured variable form with HL-7 capability.

Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.

Memory chip readers, associated software, and updates to that software must be made available to facilities.

A secure digital (SD) card or Universal Serial Bus (USB) must be supplied with each device. The SD card/USB device should be specific for use in the associated machine (no generic SD cards/USB devices will be allowed). It also must be available for purchase as a replacement item for lost/damaged SD cards/USB device.

Capacity of 2GB or more to store 90 days of “time on mask” usage data.

Full Size SD/USB (sized to fit the specific manufacturer’s devices) Class 6 or higher (SD card) Conform to IEC 60601-1 requirements.

Maintenance, Cleaning, and Infection Control:

BPAP units must be able to be cleaned and disinfected with commercially available household cleaning agents.

It must be possible to completely dismantle the water chamber and disinfect all parts.

Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.

The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.

Documentation must be provided with each machine and to the VA facility that specifies the manufacturer’s recommendations for routine servicing (including recommended resources for maintenance/ servicing).

Power Supply Specifications:

The BPAP device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.

Steady-state (“typical”) power consumption without humidifier on 120 V AC power must be ≤75 watts. Maximum power consumption with humidifier on 120 V AC power must be ≤100 watts.

Machine must have double insulated, 2-prong AC plugs for home use. Three prongs are not acceptable.

The power supply unit and power cord must be available for purchase for replacement of lost or damaged power supply and/or power cord. A separate DC adapter may be available for purchase; this optional item is preferred.

Humidifier Specifications:

When used with heated humidification, the device must provide water ingress protection if tilted 90 degrees in any direction.

Machine must have a humidifier that can be used in both heated and unheated mode.

The patient must be able to adjust humidifier settings.

When the BPAP machine is used with humidification, it must be compatible with at least 2 types of tubing manufactured by companies other than the manufacturer, except those utilizing heated-wire circuits.

Humidifier water chamber must be available for purchase as a replacement item for a lost/damaged humidifier water chamber.

Indication of Fault Conditions:

The device must indicate conditions which the user can rectify via the device display.

For all other fault conditions which require expert or manufacturer intervention, the device must indicate via the device display that a fault exists to the user, give a fault code, and advise the user to refer to the provider/manufacturer.

Assembly: BPAP machines must leave the manufacturer fully assembled, complete with attachable humidifier. They must be shipped as individual units in standard commercial configuration.

Each PAP device offered and supplied under the contract (s) shall include typical items customarily included with new sales to the general public, and at a minimum include, Case, Tubing, Filters, Power Cord, SD Cards, Instructions.

Warranties: All BPAP machines shall be covered by at least a standard commercial warranty of a minimum of two (2) years, with five (5) years preferred, for the device, and 90 days on any accessories. If the manufacturer/vendor standard warranty exceeds the specified warranty, the manufacturer’s/vendor’s standard warranty will apply for all associated parts including humidifier, power supply, and BPAP generator.

5. BILEVEL POSITIVE AIRWAY PRESSURE (BPAP) MACHINES WITH SPONTANEOUS-TIMED (S/T) CAPABILITIES (CLIN 0003C):

1. Provide documentation (certificate or equivalent) that products meet the requirements of the International Organization for Standardization (ISO) 80601-2-70:2015: Medical Electrical Equipment-Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.

Provide documentation (certificate or equivalent) that products meet the requirements of the ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.

Provide documentation (certificate or equivalent) that products meet United States FDA 510K Standard.

Provide documentation (certificate or equivalent) that products meet Radio Technical Commission for Aeronautics/ Environmental Conditions and Test Procedures for Airborne Equipment (RTCA/DO-160G) section 21, category M, Emission of Radio Frequency Energy.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1-2:2014 Electromagnetic Compatibility and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

General Device Specifications:

Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.

The device serial number shall be visible on the outside of the box.

A power cord and operating instructions brochure must be supplied with the device.

All BPAP machines must have integrated humidifier.

BPAP machine (with empty humidifier) must weigh 7lbs or less.

Offerors must provide documentation that demonstrates that they have tested each PAP device submitted for noise volume in dB while at 10 cm H2O pressures. Testing must be done in accordance with the ISO 80601-2-70:2015 and must be below 40 dB at 10 cm H2O pressures.

Machine must accept and work properly with facial interfaces from at least three different manufacturers.

Machines must have a carrying case that accommodates the machine, facial interface, and tubing.

Machine must be able to use standard size tubing: Length 6-12 feet, diameter dependent on PAP machine requirements (i.e. 15mm, 22mm or as required by the specific machine, with a female connector).

Machine must accommodate tubing with heating coil.

Operating Instructions: Must be provided in the English language for both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.

Operational Modes: There must be two modes of operation as detailed below:

Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.

User Mode - enables a limited range of comfort settings to be made and adjusted by the user.

Prescribed Parameter Set-Up: Must be possible through ALL of the following methods.

Directly from operation keys on the BPAP device Remotely using PC/Mac software via USB drive/data card application Remotely using secure wireless, cloud-based technology BPAP Parameter Settings:

BPAP machine inspiratory and expiratory pressures must be independently adjustable.

BPAP inspiratory and expiratory time periods must be independently adjustable.

BPAP with spontaneous-timed (S/T) capability must have selectable back-up breathing rates between an inclusive lower limit of 6 times per minute and an inclusive upper limit of 20 times per minute.

BPAP machines with S/T capability must also operate without a set back-up breathing rate. (BPAP “S” capability).

Data Parameters, Access, and Storage:

Wireless data transmission must be available on every BPAP machine with a secure Cloud based platform that allows provider management of sleep apnea patients.

Machine must store a minimum of 90 days of "time-on-mask" usage data downloadable using a memory-chip AND secure wireless, cloud-based transmission.

Usage data must include “time-on-mask,” pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).

Usage date must be made available in structured variable form with HL-7 capability.

Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.

Memory chip readers, associated software, and updates to that software must be made available to facilities.

A secure digital (SD) card or Universal Serial Bus (USB) must be supplied with each device. The SD card/USB device should be specific for use in the associated machine (no generic SD cards/USB devices will be allowed). It also must be available for purchase as a replacement item for lost/damaged SD cards/USB device.

Capacity of 2GB or more to store 90 days of “time on mask” usage data.

Full Size SD/USB (sized to fit the specific manufacturer’s devices) Class 6 or higher (SD card) Conform to IEC 60601-1 requirements.

Maintenance, Cleaning, and Infection Control:

BPAP units must be able to be cleaned and disinfected with commercially available household cleaning agents.

It must be possible to completely dismantle the water chamber and disinfect all parts.

Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.

The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.

Documentation must be provided with each machine and to the VA facility that specifies the manufacturer’s recommendations for routine servicing (including recommended resources for maintenance/ servicing).

Power Supply Specifications:

The BPAP device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.

Steady-state (“typical”) power consumption without humidifier on 120 V AC power must be ≤75 watts. Maximum power consumption with humidifier on 120 V AC power must be ≤100 watts.

Machine must have double insulated, 2-prong AC plugs for home use. Three prongs are not acceptable.

The power supply unit and power cord must be available for purchase for replacement of lost or damaged power supply and/or power cord. A separate DC adapter may be available for purchase; this optional item is preferred.

Humidifier:

When used with heated humidification, the device must provide water ingress protection if tilted 90 degrees in any direction.

Machine must have a humidifier that can be used in both heated and unheated mode.

The patient must be able to adjust humidifier settings.

When the BPAP machine is used with humidification, it must be compatible with at least 2 types of tubing manufactured by companies other than the manufacturer, except those utilizing heated-wire circuits.

Humidifier water chamber must be available for purchase as a replacement item for a lost/damaged humidifier water chamber.

Indication of Fault Conditions:

The device must indicate conditions which the user can rectify via the device display.

For all other fault conditions which require expert or manufacturer intervention, the device must indicate via the device display that a fault exists to the user, give a fault code, and advise the user to refer to the provider/manufacturer.

Assembly: BPAP machines must leave the manufacturer fully assembled, complete with attachable humidifier. They must be shipped as individual units in standard commercial configuration.

Each PAP device offered and supplied under the contract (s) shall include typical items customarily included with new sales to the general public, and at a minimum include, Case, Tubing, Filters, Power Cord, SD Cards, Instructions.

Warranty: All BPAP machines shall be covered by at least a standard commercial warranty of a minimum of two (2) years, with five (5) years preferred, for the device, and 90 days on any accessories. If the manufacturer/vendor standard warranty exceeds the specified warranty, the manufacturer’s/vendor’s standard warranty will apply for all associated parts including humidifier, power supply, and BPAP generator.

6. VOLUME ASSURED PRESSURE SUPPORT (VAPS) MACHINES (CLIN 0004):

1. Provide documentation (certificate or equivalent) that products meet the requirements of the International Organization for Standardization (ISO) 80601-2-70:2015: Medical Electrical Equipment-Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.

Provide documentation (certificate or equivalent) that products meet the requirements of the ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.

Provide documentation (certificate or equivalent) that products meet United States FDA 510K Standard.

Provide documentation (certificate or equivalent) that products meet Radio Technical Commission for Aeronautics/ Environmental Conditions and Test Procedures for Airborne Equipment (RTCA/DO-160G) section 21, category M, Emission of Radio Frequency Energy.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

Provide documentation (certificate or equivalent) that products meet the IEC 60601-1-2:2014 Electromagnetic Compatibility and all ISO collateral and particular standards cited by ISO (i.e., ISO 80601-2-70:2015 and IOS 80601-2-74:2017) / IEC (i.e., IEC 60601-1 and IEC 60601-1-2:2014) standards.

General Device Specifications:

Devices must be supplied in individual, standard commercial packaging in standard commercial configuration.

The device serial number shall be visible on the outside of the box.

A power cord and operating instructions brochure must be supplied with the device.

All VAPS machines must have integrated humidifier.

VAP machine (with empty humidifier) must weigh 7lbs or less.

Offerors must provide documentation that demonstrates that they have tested each PAP device submitted for noise volume in dB while at 10 cm H2O pressures. Testing must be done in accordance with the ISO 80601-2-70:2015 and must be below 40 dB at 10 cm H2O pressures.

Machine must accept and work properly with facial interfaces from at least three different manufacturers.

Machines must have a carrying case that accommodates the machine, facial interface, and tubing.

Machine must be able to use standard size tubing: Length 6-12 feet, diameter dependent on PAP machine requirements ((i.e. 15mm, 22mm or as required by the specific machine, with a female connector).

Machine must accommodate tubing with heating coil.

Operating Instructions: Must be provided in the English language for both prescriber and user with diagrams, figures, and pictures. User instructions must be written at a 6th grade level.

Operational Modes: There must be two modes of operation as detailed below:

Prescriber/Clinician Mode - enables settings to be made and adjusted by the prescriber and PAP technicians. Prescribers and PAP technicians must be able to lock the settings made so that the user cannot make adjustments to the parameters set.

User Mode - enables a limited range of comfort settings to be made and adjusted by the user.

Prescribed Parameter Set-Up: Must be possible through ALL of the following methods.

Directly from operation keys on the VAPS device Remotely using PC/Mac software via USB drive/data card application Remotely using secure wireless, cloud-based technology VAPS Parameter Settings:

Inspiratory and expiratory pressures must be independently adjustable.

Tidal Volume must be independently adjustable.

Inspiratory time periods must be independently adjustable.

Respiratory rate must be independently adjustable.

Machine must have selectable back-up breathing rates between an inclusive lower limit of 6 breaths per minute and an inclusive upper limit of at least 30 breaths per minute.

Data Parameters, Access, and Storage:

Wireless data transmission must be available on every APAP machine with a secure Cloud based platform that allows provider management of sleep apnea patients.

Machine must store a minimum of 90 days of "time-on-mask" usage data downloadable using a memory-chip AND secure wireless, cloud-based transmission.

Usage data must include “time-on-mask,” pressure(s) delivered, mask leak, and estimation of residual sleep disordered breathing events (AHI and residual event types including obstructive apneas, hypopneas, clear airway apneas).

Usage date must be made available in structured variable form with HL-7 capability.

Summarized data must be provided for 4 weeks or more, and full disclosure data must be provided for 3 nights or more.

Memory chip readers, associated software, and updates to that software must be made available to facilities.

A secure digital (SD) card or Universal Serial Bus (USB) must be supplied with each device. The SD card/USB device should be specific for use in the associated machine (no generic SD cards/USB devices will be allowed). It also must be available for purchase as a replacement item for lost/damaged SD cards/USB device.

Capacity of 2GB or more to store 90 days of “time on mask” usage data.

Full Size SD/USB (sized to fit the specific manufacturer’s devices) Class 6 or higher (SD card) Conform to IEC 60601-1 requirements.

Maintenance, Cleaning, and Infection Control:

VAPS units must be able to be cleaned and disinfected with commercially available household cleaning agents.

It must be possible to completely dismantle the water chamber and disinfect all parts.

Machine must use either washable or disposable filters and accept optional pollen, ultra-fine, or HEPA filters.

The device must not require any user maintenance other than external cleansing, humidifier cleaning, and changing/cleaning of particulate filters throughout its lifetime.

Documentation must be provided with each machine and to the VA facility that specifies the manufacturer’s recommendations for routine servicing (including recommended resources for maintenance/ servicing).

Power Supply Specifications:

The VAPS device must have an automatic universal power supply that will allow 100 to 240 V AC operation at 50-60Hz with no need for changes to any settings.

Steady-state (“typical”) power consumption without humidifier on 120 V AC power must be ≤75 watts. Maximum power consumption with humidifier on 120 V AC power must be ≤100 watts.

Machine must have double insulated, 2-prong AC plugs for home…