Attachment C - Compliance Spreadsheet.xlsx

XLSX spreadsheet 28 KB Posted

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Corporate Exigency Contract Solicitation for Aeromedically Certified Defibrillator/Monitor-Recorder
Solicitation number
SPE2D1-24-R-0001
Issued by

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This document is an Attachment C - Compliance Spreadsheet for a federal contract opportunity for an aeromedically certified defibrillator/monitor-recorder. The spreadsheet details the key performance parameters, system attributes, and other technical requirements that the proposed device must meet, such as having airworthiness certification, providing defibrillation and cardioversion functionality, supporting various patient monitoring capabilities, operating on battery and line power, and incorporating alarms and data recording.

The related federal contract opportunity is a Corporate Exigency Contract Solicitation issued by the Defense Logistics Agency Troop Support Medical for aeromedically certified defibrillator/monitor-recorders. The intent is to establish long-term partnerships with manufacturers to provide sustainment support during contingency operations. Proposed items must be aeromedically certified by all services at the time of solicitation closing. The contract award will include a 1-year base period and 4 one-year option periods.

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Other files

File Type Posted
SF30_SPE2D124R00010002.PDF PDF
Attachment C - Compliance Spreadsheet - Amendment.xlsx XLSX spreadsheet
SF30_SPE2D124R00010001.PDF PDF
Attachment A - RFP SPE2D1-24-R-0001 Continuation Pages.pdf PDF
SF1449_SPE2D124R0001.PDF PDF
Attachment B - MediPrice Template.xlsx XLSX spreadsheet

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ECs for Defibrillator

Please use the following compliance codes when respond in this column ("COMPLIES"): C- Current product fully complies; P- Not part of current product but planned in schedule release (Vendor shall indicate the time when the requirement will be available); N- Product does not comply: NA - Product not offered.
Essential CharacteristicThreshold (T)Objective (O)CompliesExplanation of conformance or nonconformance with proposal reference
1.00Key Performance Parameters
1.01Shall have a Joint Airworthiness Certification (JAC) consisting of a “Safe-to-Fly” letter from the USAF for fixed and rotary wing aircraft and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification Letter (AWC) from the US ArmyRequiredT=O
1.02Device must be “approved for market” (PMA), “cleared to market” (FDA 510k approval); or “legally marketed” (as defined in the Code of Federal Regulations – 21 CFR807.97(a)(3) for Class I and II devices)RequiredT=O
2.00Key System Attributes
2.01Shall have electrocardiograph monitoring with capability to view two leads simultaneouslyYesT=O
2.02Shall provide defibrillation functionalityYesT=O
2.03Shall provide synchronized cardioversionYesT=O
2.04Shall provide external transcutaneous pacemakerYesT=O
2.05Shall provide non-invasive blood pressure (NIBP) measurement for adult, pediatric and infant/neonate patientsYesT=O
2.06Shall provide pulse oximetryYesMotion Tolerant Pulse Oximetry
2.07Shall provide a minimum of two ports each for Temperature Monitoring and Invasive blood pressure (IBP) monitoring2 ports each2 temp ports and 4 IBP ports
2.08Shall provide End-Tidal Carbon Dioxide monitoringYesT=O
2.09Shall provide 3, 5 and 12 lead Electrocardiograph (ECG) functionalityYesT=O
2.10Shall provide Arrhythmia, ST and QT monitoring with alarm when outside parameters.YesT=O
2.11Shall provide Pleth Variability Index (PVI)YesT=O
2.12Shall provide Perfusion IndexYesT=O
2.13Shall provide Met hemoglobin (SpMet)YesT=O
2.14Shall provide Total Hemoglobin (SpHb)YesT=O
2.15Shall provide arterial oxygen contentYesT=O
2.16Shall provide arterial Wave FormsYesT=O
2.17Shall provide Impedance RespirationYesT=O
2.18Shall provide Carboxyhemoglobin (SpCO)YesT=O
2.19Shall have Cardiovascular Reserve Index (CRI)YesT=O
2.20Shall monitor Heart/Pulse RateYesT=O
2.21Shall be an integral or modular portable defibrillator-monitor recorder. Units which are modular in design and can be separated shall consist of only two separate components; these being a defibrillator and a monitor/recorder. If the unit is modular each component shall be independently powered and shall securely interconnect into a physically contiguous unit without the use of tools, without the need for auxiliary cables and in such a manner as not to create excessive stress on the electrical connectorsYesT=O
2.22System shall conform to IEC 60601-2-27, Medical Electrical Equipment General Requirements for Safety – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsYesT=O
2.23The system shall have available, as accessory components adult defibrillation pads, cable for defibrillation pads, electrocardiography lead wires, recording paper and padded case. All cables and accessories (to include disposables) needed to initially operate the device will be included within the case. Device shall be have available two 5-lead ECG patient cables (10 foot minimum length; three (3) each pre-gelled electrodes; one each temperature, NIBP, 12-lead and invasive pressure cables; one each CO2 sensor and airway adapter set; one each extension cable (minimum length of 8 foot (2.4 meter) and two (2) each disposable pulse oximetry sensors to fit child and adult. Must include one 110 – 240VAC, 50/60/400HZ power cord adapter.YesT=O
2.24Shall be portable and impact-resistant and operable in wet, dry and dusty environments. The monitor-defibrillator shall be made available in a weatherproof hard case capable of protecting its contents from a weight appropriate drop in accordance with MIL-STD-810G if required by the purchasing agency.YesT=O
2.25Unit must be safe to operate after a drop test of specified height3 Feet6 Feet
2.26Shall operate from both external source and battery power. Unit must be able

to run on line power during recharge as well as recharging battery

simultaneously.YesT=O
2.27Shall incorporate Automatic External Defibrillation (AED) functionYesT=O
2.28Shall defibrillate or cardiovert via cable with defibrillation pads with controls for energy selection and discharge located on the unitYesT=O
2.29Shall automatically revert to asynchronous energy delivery after discharging when in synchronized cardioversion modeYesT=O
2.30Shall accommodate pediatric paddles and/or defibrillation padsYesT=O
2.31Shall accommodate internal paddlesYesT=O
2.32Shall have adult and pediatric defibrillator internal and external paddles for debrillation or cardioversion.
YesT=O
2.33Shall provide custom selection for a minimum of 3 viewable EKG waveforms simultaneously including adult, pediatric and infant/neonate for customized monitoring and specific patient populations3 viewable waveforms5 viewable waveforms
2.34The Defibrillator display configuration shall feature a large simultaneous of

at least 3 EKG waveforms and numeric value, C02 waveform and numeric value, and pulse oximetry values and waveform, non-invasive blood pressure display, temperate display and have adult, pediatric and

neonatal configuration capability.YesT=O
2.35Shall use a bi-phasic waveform of energy delivery for defibrillation or cardioversionYesT=O
2.36Shall provide a range of defibrillation or cardioversion energy delivery suitable for infant/neonatal through adult patientsYesT=O
2.37Shall be able to charge to full discharge power within 15 seconds throughout the full range of battery charge levelYes10 Seconds
2.38Shall incorporate an audible indicator to inform the operator when the capacitor is charged and the device is ready for dischargeYesAudible and Visual
2.39Shall have a clearly visible marker displayed on the monitor to indicate the synchronization point on electrocardiographYesT=O
2.40Shall automatically disarm within two minutes if not intentionally dischargedYesT=O
2.41Shall have an external pacemaker rate range of at least 60 to 150 beats per minute minimum that allows for asynchronous (fixed-rate) and synchronous (demand) external pacingYesT=O
2.42Shall have an adjustable external pacemaker output of up to 140mAYesT=O
2.43Shall provide feedback for compression depth and rate during CPRYesT=O
2.44Shall operate at 110 – 240VAC, 50, 60, and 400HZ (@110VAC)YesT=O
2.45Shall have a battery charge level indicator, shall illuminate when batteries

are charging and display a low battery message on the monitor screen as

necessary.YesT=O
2.46Shall be able to maintain patient data while swapping batteries for a minimum of 2 minutesYesT=O
2.47Shall be operable solely on battery power for a minimum of 2 hours while providing monitoring of all patient parameters and a minimum of ten (10) defibrillations or cardioversions at maximum energy levels>2 hours> 4 hours
2.48Shall be able to recharge to full charge in 6 hours or less< 6 hours< 3 hours
2.49Shall be able to run on line power during recharge as well as recharging the battery simultaneouslyYesT=O
2.50Battery life shall be met with no more than 2 batteries2 Batteries1 Battery
2.51If requested by purchasing agency, the monitor-defibrillator shall include

an external battery charger that provides charging and conditioning of the

number of batteries the unit requires simultaneously.Single Battery BayMulti Battery Bay
2.52Shall be able to adjust printer for either 25mm or 50mm per second speedYesT=O
2.53Shall allow for electrocardiograph monitoring through leads, paddle and combination defibrillation/cardioversion padsYesT=O
2.54Monitor display shall be adjustable for either 25mm or 50mm per second sweep speedYesT=O
2.55Monitor display illumination shall be adjustable for lightness and brightness including the ability to be dimmed and shall enable use with Night Vision Goggles (NVGs) without use of external filtersYesT=O
2.56Monitor waveforms and numeric values shall have individual distinct colorsYesT=O
2.57Shall incorporate visual and audible alarms to signal critical patient conditions including life threatening dysrhythmias, vital signs that deviate from user defined limits and invasive monitoring values that deviate from user defined limits (IAS IEC 60601-1-8) Alarm values shall be selectable
for adult, pediatric and neonate.YesT=O
2.58Shall have visual alarms that are adjustable for lightness and brightness and have the ability to be dimmedYesT=O
2.59Audible alarms shall be adjustable for volume including the ability to be mutedYesT=O
2.60Shall communicate waveforms and vital signs data to display and recording devicesYesT=O
2.61Shall retain a minimum of 60 minutes of patient history for transfer to an electronic device or printer. The wireless feature must be able to be turned on/off by the user.>60 min>240 min
2.62Shall be net-ready by wireless and hardware for electronic systems. Vendors shall only offer items, which already have an Authorization to Operate (ATO), or items for which the Vendor agrees to go through the IA approval process and obtain an RMF ATO.
YesT=O
2.63Shall have a handle for carryingYesT=O
2.64The system shall incorporate an option for attachment of the device to a litter or poleYesT=O
2.65Shall enable achievement of a 25% reduction in weight over the current defibrillator and patient monitor used in USAF Aeromedical Operations; the current weight of the two systems is 26 pounds; therefore the threshold for a 25% reduction is 19.65 pounds<19.65 lbs<15 lbs
2.66The device shall be capable of mounting to the existing Vital Signs Monitor bracket on the Special Medical Emergency Evacuation Device (SMEED)YesT=O
2.67Government shall have access to OEM repair parts, proprietary software and tools and service literature for DoD trained Bio Medical Repair Technicians without requiring attendance at OEM factory training. Systems that do not require proprietary tools or equipment for maintenance are strongly preferred.YesT=O
2.68Quality control modules and test equipment shall be included to allow testing, repair, maintenance and calibration by DoD Biomedical Repair TechniciansYesT=O
2.69Service and operator manuals shall be available both electronically and in print. Shall also include, but not limited to: all schematics (e.g., electronic, pneumatic, as applicable), troubleshooting guide, and theory of operation. Service manual should include parts layout with part numbers for each replaceable component. Service manuals should be identical to vendor service technician’s manuals and should not require vendor service.YesT=O
2.70The Device shall have Operational and Storage temperature ranges within allowable limits for cold and hot storage and operational environments perJoint Enroute Care Equipment Test Standard (JECETS) which specifies temperature limits and specifies using the test methods in 810G for Tactical-Standby to Operational environmental Tests.YesT=O
2.71Device shall be Wi-Fi, Bluetooth and Ethernet capable and have a USB port for data transfer. Device shall have ability to transmit into current/future Electronic Health Record with IR Capablility. Device must have the capability to turn-off Wi-Fi and Bluetooth.YesT=O
2.72The device shall have defibrillator overload protection as described by IEC
60601-1.YesT=O
2.73The system shall have Unique Item Identification markings in compliance with DFARS 252.211-7003YesT=O
2.74The supplier shall provide training on the device for operator and maintenance training, both for initial and future deployment, as well as the cost of available training courses and materials. Training materials and courses used in commercial deployment of the monitor devices are preferred. Training materiel must be CD, printed maunual form and web-based.YesT=O
2.75The device shall have the capability to output recorded data to an external printer via standard USB port or other interface for up to three waveforms numeric for all vital signs. The recorder shall be capable of automatically recording the direct or delayed waveform signals when manually initiated or when an alarm condition occurs. The device shall have the option for a printer and paper recorder suitable for the use in a deployed environment.Shall have the capability

to output recorded data to an EXTERNAL PRINTER via standard USB port or other interface (up to (3) five waveforms numerics for all vital signs.) Shall have an INTEGRAL

STRIP CHART

RECORDER THAT

PRINTS to an output printer a paper record of selected parameters (up to

(5) three waveforms numerics for all vital signs.)

2.76Device system software shall be upgradeable in the field by military Biomedical Repair Technicians, with or without internet connection, using a computer interface, the internet or a CD supplied by the OEM without requiring changing hardware components of the device; OEM shall provide notification of product software modifications and/or updates to customer and outdated software shall not render the device unusableYesT=O
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