Call 1 - JMCIP - Attachment 3 System Requirements Document (SRD) Requirements List.pdf

JMCIP Requirement List

JMCIP SRD PUI # JMCIP SRD Requirements

FDA KPP. JMCIP shall be designed, tested, validated, per 21 Code of Federal Regulations (CFR 820) and cleared by the U.S. Food and Drug Administration as a medical device IAW applicable regulations and Standards. (T=O)

Multi-channel Infusion Pump KPP. The JMCIP shall be a multi-channel (defined as 3 or more channels in one device) intravenous infusion pump capable of delivering fluids, blood products, medication, and nutrients. (T=O)

Caregiver Operation. JMCIP, within the context of safety and efficacy, shall have the capability for the caregiver to program, reprogram, or restart the device. (T=O)

Drug Library. JMCIP shall have drug library to include, but not limited to at least 10 care areas with at least 100 drug entities per care area, user configurable that can be updated by appropriate medical personnel and includes a Dose Error Reduction System (DERS). (T=O)

Secondary Infusion. JMCIP shall have a secondary “piggy-back” infusion function, which will automatically revert back to the primary infusion rate once the secondary VTBI is completed. (T=O)

Dose Calculator. JMCIP shall have Dose Calculator that will automatically calculate values based upon user provided variables. (T=O)

7 Free-flow Protection. JMCIP shall provide free-flow protection. (T=O)

Needleless Infusion Set. JMCIP shall include the capability for needleless infusion using needleless (luer lock) standard tubing. (T=O)

Volume to be Infused (VTBI). JMCIP infusion volume for each channel shall meet 0.1 to 9,999 ml. (T=O).

Keep Vein Open (KVO) Capability. JMCIP shall revert to a KVO rate between 1 and 20 mL/hr, but not greater than the programmed flow rate, once the programmed VTBI is delivered. (T=O)

Infusion Rate. JMCIP infusion rate, without rapid infuser capability, for each channel shall have a selectable range of 0.1-999 mL/hr (T), 0.1–1500 mL/hr (O).

Bubble Detection. JMCIP shall be capable of detecting and removing bubbles.

(T=O)

Display. JMCIP shall display the following data to include, but not limited to:

Infusion status, screen lock status, drug name, dose, concentration, primary or secondary infusion, infusion rate, volume to be infused (VTBI), patient weight (if used; lbs/kg), soft and/or hard dose limits, volume infused, profile name, channel indicator, patient identification, dynamic pressure display, alarm information, battery charge level (in 20% increments), battery present, FA8650-20-S-6008, Call 1 Attachment 3 - System Requirements Document (SRD) Requirements List

18 February 2022

Bluetooth/Wi-Fi indicator, and industry standard units in US drug calculations (i.e., mcg/kg/min to u/hr) (T=O)

Flow Rate Accuracy. JMCIP shall have flow rate accuracy of IAW IEC 60601- 2-24 standard. (T=O)

Patient Populations. JMCIP shall be compatible for all patient populations (Pediatrics to Adult) and veterinary patients. (T=O)

Historical Record/Event Log. JMCIP shall maintain historical record/event log to include, but not limited to: system settings, alarms, system errors, all changes, drug menu, dose limit warnings, volume measurements (total volume infused, total secondary volume infused), rate and flow adjustments and medication changes, date/time stamp, and patient identification. (T=O)

System Software Upgrades. JMCIP shall have the capability to upgrade the system software. (T=O)

AC/DC Power Sources. JMCIP shall use electrical power for system operation, with or without battery installed, and interface with the external power consisting of 110/220 VAC, 50-60 Hertz (T) and 110/220 VAC 50/60/400 Hz, 12-24VDC power supply sources. (O)

Alarms. JMCIP shall have variable audible and visual alarms as appropriate for infusions pumps IAW applicable FDA guidance and IEC 60601-1-8, Medical Electrical Equipment – Part 1-8. Alarm(s) shall be capable of being audibly muted and visually suppressed by the operator. (T) Visual alarms shall have 360 degree visibility. (O)

Safe-To-Fly/Air Worthiness Recommendation KPP. JMCIP device to include securing mechanism and AC power adapter shall obtain STF/AW recommendation letter from the USAF ATL and the USAARL by meeting Safe-To-Fly (STF)/Air Worthiness (AW) requirements IAW the Joint En-Route Care Equipment Test Standard (JECETS) for fixed and rotary wing aircraft.

JECETS Test/Assessment Item summary table listed in Appendix E. (T=O)

Operational Temperatures. JMCIP shall start and sustain operation in ambient temperatures of 35°F and +120°F. (T=O)

Storage Temperatures. JMCIP shall operate after exposure to storage temperatures of -4°F and 131°F. (T=O).

Salt Fog. JMCIP shall operate during and after exposure to salt fog. (T=O)

RMF Compliance JMCIP shall comply with DoD Risk Management Framework (RMF) cybersecurity requirements. The vendor shall receive a full A&A RMF ATO/ATC for JMCIP and any applicable components (including any third-party items) prior to being allowed to provide production quantities.

(T=O)

Data Communications. JMCIP shall be capable of universal connectivity utilizing USB, Ethernet, or RS485 for direct communications and Wi-Fi, and Bluetooth or other industry standards for wireless communications IAW applicable FDA Guidance and Industry Standards. (T=O)

FA8650-20-S-6008, Call 1

Wi-Fi / Bluetooth On/Off Feature. JMCIP Wi-Fi / Bluetooth connection shall have on/off selection capability. (T=O)

Electronic Health Record System Interface. JMCIP shall be capable of interfacing with Electronic Health Record/Electronic Medical Record systems to document infusion status and administration via HL7, FHIR, or similarly DoD compliant standard format IAW applicable FDA Guidance and Industry Standards. (T=O)

Mean Time Between Failure. JMCIP shall have a minimum Mean Time Between Failure (MTBF) of 2880 hours. The MTBF is a measure of the average operating time between any failure of the system, excluding scheduled maintenance. (T=O)

Mean Time To Repair. JMCIP Mean Time to Repair (MTTR), using organizational level maintenance, to remove and replace major subcomponents and conduct preventive maintenance shall be no greater than one hour from receipt of items required for repair. (T=O)

Pump Operation Orientation. JMCIP shall be able to accurately pump fluid at the specified flow rate regardless of the pump orientation in the vertical, horizontal positions (T) and upside down (O).

Fluid Elevation. JMCIP shall be able to accurately pump fluid at the specified flow rate regardless of the pump position relative to the position of the fluid being administered (i.e. fluid above, level to, or below the pump’s height).

(T=O)

Securing Device. JMCIP shall have a “universal” mechanism for mounting and securing the device on military litters, standard medical device poles, and patient movement platforms. (T=O)

Visual Indicators. JMCIP shall have visual indicators of system status and identification of alarms as appropriate for infusion pumps. (T=O)

Rechargeable Battery Operation. JMCIP shall be able to operate on rechargeable battery power for 6 hours (T), 8 hours (O) at with all channels operating at the same time at a flow rate of 125 mL/hr and automatically switch to battery power upon interruption of AC power. (T=O)

[33] Battery Charging Time. JMCIP battery shall be fully charged in ≤8 hours (T), ≤ 6 hours (O) at 10% charge remaining with JMCIP connected to AC power independent of the Power On/Off switch position.

Battery Charge Indicator. JMCIP shall have a battery charge indicator visible to the operator at all times during operation displaying the percent of battery power remaining in 20% increments. (T=O)

Battery Shelf Life. JMCIP integral rechargeable battery have a shelf life of 3 years (T), and > 3 years (O).

Battery Replacement. JMCIP battery shall be capable of being removed and replaced in 5 minutes using no tools or stock-listed tools (see Appendix F).

(T=O)

FA8650-20-S-6008, Call 1

Weight. JMCIP weight as a single device shall be less than six (6) pounds, including a rechargeable battery and internal charger. (Weight excludes JMCIP accessories). (T=O)

System Size. JMCIP device shall have a total volume of no more than 0.057cubic feet. (Size includes battery but excludes JMCIP accessories) (T=O)

41 Self-Test. JMCIP shall perform a power on self-test during both AC and DC (battery) operation to indicate system readiness. (T=O)

Cleaning & Disinfection. JMCIP components shall be capable of withstanding cleaning and disinfection with standard hospital detergents and disinfectants without deterioration of material, surface finish and performance as prescribed by Center for Disease Control (CDC), Standard Operational Practices, and applicable FDA guidance. (T=O)

43 Operational Life. JMCIP shall have an operational life of 9 years (T), > 10 years (O) (excludes battery).

44 Low Light Operation. JMCIP displays shall be capable of operation in low light conditions (dimming the display at night). (T=O)

45 Display Visibility. JMCIP shall have a display that is visible in bright daylight.

(T=O)

46 Noise. JMCIP shall emit less than 45 dBA (T), 35 dBA (O) when measured at a radius of 1 meter from JMCIP IAW IEC 60601-1.

Operation with Personal Protective Equipment (PPE). JMCIP shall be operable by personnel using PPE (i.e. surgical gloves/mask, cold weather gloves and MOPP gloves, hood, and mask). (T=O)

Maintenance. JMCIP shall be capable of being maintained with biomedical equipment by a graduated biomedical equipment technician using stock-listed tools as shown in Appendix F. (T=O)

IUID. JMCIP shall meet the Item Unique Identification (UID) machine readable information marking IAW MIL-STD-130 or DoD recognized IUID equivalent. (T=O)

50 Disposal. Disposal of any of the JMCIP components shall not pose a threat to the environment. (T=O)

Acronyms and Definitions

A&A - Assess & Authorize AC – Alternating Current AE – Aeromedical Evacuation ATL - Aeromedical Test Laboratory ATO/ATC - Authority to Operate/Authority to Connect AW - Air Worthiness CDC – Center for Disease Control

FA8650-20-S-6008, Call 1

CDD – Capability Development Document CFR – Code of Federal Regulations dBA – Decibels (Acoustic) DC – Direct Current DERS - Dose Error Reduction System ERC - En-Route Care F - Fahrenheit FDA – Food and Drug Administration Hz – Hertz IAW – In Accordance With IEC – International Engineering Consortium IUID - Item Unique Identification JECETS - Joint En-Route Care Equipment Test Standard JMCIP - Multi-channel Infusion Pump KPP – Key Performance Parameter KVO - Keep Vein Open MIL-STD – Military Standard mL/hr – milliliter per hour MOPP – Mission Oriented Protective Posture MTBF – Mean Time Between Failure MTTR – Mean Time To Repair MCIP – Multi-channel Infusion Pump PPE – Personal Protective Equipment PUI - Project-Unique Identifier RMF – Risk Management Framework SRD - System Requirement Document TBD – To Be Determined STF - Safe-To-Fly USAARL -US Army Aeromedical Research Laboratory USAF – United States Air Force VAC – Volts Alternating Current VDC – Volts Direct Current VTBI - Volume To Be Infused

FA8650-20-S-6008, Call 1