The file's text, extracted by GovTribe without its formatting.
Advanced Medical Monitor (AMM) Consolidated Performance Parameters (CPPs)
1.0 System Description
The Advanced Medical Monitor (AMM) capability will consist of noninvasive advanced physiological monitoring solutions that enable monitoring of multiple casualties from Point of Injury (POI) through Role 3 hospital care. This monitoring capability will also enable actionable information to enhance patient triage, informing treatment and evacuation priorities, as well as monitoring vital signs of casualties receiving medical care. Family of Systems (FoS) components will allow for transfer of patient data through the roles of care. The solutions may include individual sensors, advanced medical monitors, and/or decision support algorithms.
2.0 Performance Parameter Definitions
Each parameter articulates a performance attribute considered critical or desirable for the development of an effective military capability. Performance parameters categorized as “Critical Parameters” are non-negotiable and essential to the device. Performance parameters categorized as “Desired Characteristics” are sought but are not identified as critical or essential.
The overarching AMM parameters apply to both the Next Generation Medical Monitor (NGMM) and Expeditionary Medical Monitor (EMM) devices. Performance parameters are summarized by AMM Parameters, NGMM Parameters, and EMM Parameters in sections 2.1, 2.2, and 2.3 and further defined as critical and desired parameters in subsections 1 and 2 of each.
2.1 AMM Parameters
The overarching AMM KPP performance parameters apply to the Next Generation Medical Monitor (NGMM) and Expeditionary Medical Monitor (EMM) devices.
2.1.1 AMM Critical Parameters
The following performance parameters must be met for the AMM Family of Systems to be considered acceptable.
| Number |
| Parameter |
| Development Threshold (T) |
| Development Objective (O) |
| 1 |
| FDA Approval |
| FDA Approval or FDA Clearance. |
| T=O |
| 2 |
| Net Ready |
| Device shall meet Net-Ready Performance Attributes (see CDD). |
| T=O |
| 3 |
| Airworthiness Release/Safe-to-Fly |
| The device will meet Army Regulation (AR) 70-62, Airworthiness Qualification of Aircraft Systems AND Safe to Fly qualification IAW JECETS for fixed- and tilt-rotor and rotary-wing for patient movement items (PMI). |
| T=O |
2.1.2 AMM Desired Characteristics
The following performance parameters are desired for the overarching AMM Family of Systems.
| Number |
| Parameter |
| Development Threshold (T) |
| Development Objective (O) |
| 1 |
| Open Architecture |
| Capability shall be compatible with the HL7 FHIR standards. |
| T=O |
| 2 |
| Exportability |
| The product, inclusive of support products, will be exportable to close allies and partners (i.e., FVEY) IAW the Conventional Arms Transfer Policy and other relevant export regulations. |
| All allies and partners IAW the Conventional Arms Transfer Policy and other relevant export regulations. |
| 3 |
| Open API |
| Device software shall include API(s) compatible with Android, iOS, and Windows operating systems. |
| Compatible with Linux operating systems in addition to threshold requirements. |
2.2 NGMM Parameters
The following performance parameters apply to the NGMM and are in addition to the AMM critical and desired parameters.
2.2.1 NGMM Critical Parameters
The following performance parameters must be met for the device to be considered acceptable as a NGMM device.
| Number |
| Parameter |
| Development Threshold (T) |
| Development Objective (O) |
| 1 |
| Physiological Parameters |
| The device shall be capable of monitoring the following parameters: pulse rate or heart rate; respiratory rate; blood pressure; oxygen saturation (SpO2); core body temperature; Capnography end tidal carbon dioxide (EtCO2); electrocardiogram (EKG) rhythm; impedance respiration; perfusion index; arrythmia, ST, and OT Monitoring. |
| And connection ports for: intracranial pressure monitoring; carboxyhemoglobin (SpCO); and partial pressure of brain tissue oxygen (PBT O2). |
| 2 |
| Cyber Survivability |
| Device shall comply with the Cyber Survivability Attributes (CSA) in the CDD. |
| T=O |
2.2.2 NGMM Desired Characteristics
The following consolidated performance parameters are desired for the NGMM device.
| Number |
| Parameter |
| Development Threshold (T) |
| Development Objective (O) |
| 1 |
| Compatibility with Electronic Health Record Tools |
| Device shall be capable of interfacing with current DoD JOMIS Healthcare Delivery Platform Role 2/Role 3 and en route care electronic health record tools. |
| Device shall be capable of input and output of data from current, planned, and future DoD electronic health record tools at all roles of care. |
| 2 |
| Decision Support |
| Capability shall provide decision support to determine or predict decompensation (shock), prior to patient collapse, due to hemorrhage in seriously injured patients when signs of bleeding are not apparent using vital signs or visual observation. |
| Capability shall provide decision support to determine or predict respiratory failure, concussion, CBRN exposure, and other traumatic injury, sepsis, or other illness. |
| 3 |
| Patients Per Device |
| Device display and support software shall be capable of receiving, analyzing, and displaying data for 3 patients collected by sensors or other AMM FoS devices at the same time. |
| Device display and support software shall be capable of receiving, analyzing, and displaying data for 8 patients collected by sensors or other AMM FoS devices at the same time. |
| 4 |
| Patient Demographics |
| Device is compatible with military populations. |
| and military working dogs. |
| 5 |
| Peripheral Sensor Devices |
| In reference to the capabilities discussed in Patients Per Device parameter, NGMM will be capable of intaking data from 1 sensor device for every patient being analyzed and/or displayed by the device. |
| In reference to the capabilities discussed in Patients Per Device parameter, NGMM will be capable of intaking data from 3 sensor devices for every patient being analyzed and/or displayed by the device. |
| 6 |
| Environmental Specifications |
| The NGMM shall operate in all environmental conditions defined by MIL-STD-810H as between “Basic Cold” and “Hot Dry.” |
| and between “Cold” and “Hot Humid” |
| 7 |
| Size and Weight |
| Device shall be <700 cubic inches and weigh ≤10 lbs. (4.54 kg). |
| <400 cubic inches and weigh ≤5 lbs. (kgs). |
| 8 |
| Serviceability |
| Device must be maintainable by a BMET with a standard tool set. |
| T=O |
| 9 |
| Visual and Audio Alarm |
| Device will have a visual alarm that meets IEC 60601-1-1-8 requirements with option for blackout ops and an adjustable audible alarm that meets IEC 60601-2-24 requirements. |
| T=O |
| 10 |
| Offline Patient Data Storage |
| Device shall be capable of securely holding up to 3 days of patient data at a time while offline. |
| 7 days of patient data. |
| 11 |
| Battery Power Source |
| Non-consumable (any durable) components which require power and operate on batteries must use 110~240VAC, 50/60Hz power, be rechargeable, and be based on non-proprietary equipment/commercially available items (including charging cables). |
| Non-consumable (any durable) components which require power and operate on batteries must use 110~240VAC, 50/60/400Hz power, be rechargeable and field replaceable, hot-swappable, and be based on non-proprietary equipment/commercially available items (including charge cables). |
| 12 |
| Blood Oxygen Measurement |
| Device shall monitor oxygen via SPO2 |
| Or STO2 |
| 13 |
| Defibrillation |
| Device supports manual defibrillator operations. |
| Device supports automatic external defibrillator operations. |
| 14 |
| CPR Monitoring |
| Device supports CPR monitoring. |
| For patients including military working dogs. |
| 15 |
| External Transcutaneous Pacing |
| The device can be used for temporary external cardiac pacing in adult military patients. |
| All patients. |
| 16 |
| Battery Life |
| Device shall operate for greater than or equal to 6 hours on battery power. |
| 8 hours |
2.3 EMM Parameters
The following performance parameters apply to the EMM and are in addition to the AMM critical and desired parameters.
2.3.1 EMM Critical Parameters
The following consolidated performance parameters must be met for the device to be considered acceptable as an EMM device.
| Number |
| Parameter |
| Development Threshold (T) |
| Development Objective (O) |
| 1 |
| Physiological Parameters |
| Device shall be capable of measuring heart rate, non-invasive blood pressure, respiratory rate, blood oxygen level, and estimated core body temperature. |
| And capnography |
| 2 |
| Cyber Survivability |
| Device shall comply with CSAs (See CDD). |
| T=O |
2.3.2 EMM Desired Characteristics
The following consolidated performance parameters are desired for the EMM device.
| Number |
| Parameter |
| Development Threshold (T) |
| Development Objective (O) |
| 1 |
| Interface/Interoperability |
| Device shall be capable of interfacing with current DoD JOMIS Healthcare Delivery Platform POI/Role 1 and en route care electronic health record tools. |
| Device shall be capable of interfacing with current and future DoD electronic health records at all roles of care. |
| 2 |
| Monitoring of Multiple Patients |
| Device EUD shall support simultaneous monitoring of parameters defined in Critical Parameter 1 - Physiological Parameters for up to 10 patients by an EUD. |
| 20 patients by an EUD. |
| Capability shall provide decision support to determine or predict decompensation (shock), prior to patient collapse, due to hemorrhage in seriously injured patients when signs of bleeding are not apparent using vital signs or visual observation. |
| Capability shall provide decision support to determine or predict respiratory failure, concussion, CBRN exposure, and other traumatic injury or illness. |
| Size/Cube – Device |
| The device, including battery, shall not exceed 25 cubic inches, with no single device dimension may exceed 12 inches. |
Device shall not exceed 12 cubic inches.
| 5 |
| Environmental Specifications |
| The EMM shall operate in all environmental conditions defined by MIL-STD-810H as between “Basic Cold” and “Hot Dry.” |
| And between “Cold” and “Hot Humid” |
| 6 |
| Data Storage |
| Device shall be capable of securely holding up to 4 days of patient data at a time while offline. |
| 21 days of patient data |
| 7 |
| Placement on Body |
| Shall be placed on head, neck, or torso. |
| Anatomic placement agnostic |
| 8 |
| Device Display – Protective Gear Compatibility |
| Device shall be operable with infectious disease Personal Protective Equipment (PPE), cold weather gloves, and flight gloves. |
| Shall be compatible with JSLIST/CBRN protective gear for patient and provider. |
| 9 |
| Power, Rechargeability |
| Non-consumable (any durable) components which require power and operate on batteries must be rechargeable and/or hot-swappable and be non-proprietary equipment/commercially available item. |
| T=O |
| 10 |
| Battery Life |
| Device shall operate for greater than or equal to 24 hours on battery power at ambient room temperature. |
| Or 96 hours for rechargeable, hot-swappable devices/168 hours for disposable devices. |
| 11 |
| Communication |
| Device shall communicate over wired and Bluetooth low emission (Bluetooth LE) connections, with the ability to disable Bluetooth LE. |
| Device shall communicate over wired, Bluetooth low emission (Bluetooth LE), and near-field communication (NFC) connections or other future low observability wireless communication standard with the ability to disable Bluetooth LE and NFC. |
3.0 Acronyms
AMM – Advanced Medical Monitor AWR – Air Worthiness Ready BATDOK – Battlefield Assisted Trauma Distributed Observation Kit BMET – Biomedical Electronics Technician BP – Blood Pressure CBRN – Chemical, Biological, Radiological, and Nuclear CPP – Consolidated Performance Parameters CPR – Cardiopulmonary Resuscitation CSA – Cyber Survivability Attributes CUI – Controlled Unclassified Information DoD – Department of Defense EMM – Expeditionary Medical Monitor EKG – Electrocardiogram EUD – End User Device FDA – Food and Drug Administration FHIR – Fast Health Interoperability Resources FVEY – The Five Eyes FoS – Family of Systems HIPAA – Health Insurance Portability and Accountability Act HL7 – Health Level 7 HR – Heart Rate Hz – Hertz IAW – In Accordance With JECETS – Joint Enroute Care Equipment Test Standards JSLIST – Joint Service Lightweight Integrated Suit Technology MIL-STD-810H – Military Standards for Device Protection NGMM – Next Generation Medical Monitor OMDS – Operational Medicine Data Service OPMED – Operational Medicine PPE – Personal Protective Equipment RR – Respiratory Rate SPO2 – Oxygen Saturation STO2 – Skeletal Tissue Oxygen Saturation T=O – Threshold equals Objective VAC – Volts Alternating Current
Defense Health Agency