K5 Wearable Metabolic System - Sources Sought Statement of Need.pdf

K5 WEARABLE METABOLIC SYSTEM

STATEMENT OF NEED

May 4, 2022

1. Requirement: The 6 OMRS Human Performance Flight at MacDill AFB, FL has a mission need for a K5 wearable metabolic system for both laboratory and field testing. K5 portable metabolic system would allow the Human Performance Staff to evaluate Airmen using the breath-by-breath technique for measuring respiratory gas exchange during exercise in a variety of environmental conditions (especially running outdoors though), while also offering the ability to evaluate a client's metabolic efficiency/output (VO2max, along with whether primarily carbohydrates or fats were burned during exertion).

2. Characteristics: The K5 uses the latest technology, including COSMED's 4th generation opto-electronic reader and proven and reliable highly linear and rapid response O2 (GFC) and

CO2 (NDIR) sensors. IntelliMET™ (US Patent 9581539) measures gas exchange either with micro-dynamic mixing chamber or breath by breath techniques. Users can select between the two modes depending on the protocol type, research field or other factors. The K5 offers efficient wireless data transmission (both standard Bluetooth and long range Bluetooth) and seamless integration with other devices (i.e., wireless wrist-worn pulse oximeter). The K5 display assures simplified navigation and quick access to all commands and features. The status bar provides information regarding time, date, battery status, Bluetooth, GPS and notification icons (QC messages, warnings, etc.). Also included is the ability to switch between data, graphs, GPS etc., during real-time measurements. ANT+ certified. The K5 can be integrated with the world’s largest sport sensors network (up to 5 profiles available for 250+ compatible products). Up to 8 wireless devices can be contemporarily connected with the K5.

3. Inherent Services: The K5 introduces the new OMNIATM metabolic module software designed by COSMED. OMNIA provides an intuitive, and innovative user interface for the K5.

Compatible with the entire COSMED product line, OMNIA allows the user to operate complex equipment without requiring extensive training. OMNIA is compatible with the latest

Windows® OS (8.1), has a native touch screen interface, and is tablet-ready. Easy-to-use touch screen graphic user interface with intuitive workflow and hierarchy. Designed to operate on both standard PCs and tablets. Compatible with Windows 8 PRO (32/64), Windows 7 (32/64), and

Windows Vista (32/64). Mac OS compatibility when installed in Virtual PC OS (Parallels, VMware). Multi-language environment, including Italian, English, Spanish, French, German, Portuguese, Greek, Dutch, Turkish, Russian, Chinese (traditional), Chinese (simplified), Korean, Romanian, Czech, and Norwegian2. SQL database allows virtually unlimited records and data safety. Full network database management (optional). OMNIA allows installations in complex client/server environments. User access by ID and password, with the ability to create roles and users with an integrated “user management” tool. Security data solutions according to US

HIPAA, ISO 27799:2008, EU 95/46/CE and 2002/58/CE. Multi-user access rights management

Sources Sought

(i.e., Principal Investigator, Physician, Technician, and Administrator) with event logging. Easy data and graph display through either pre-defined dashboards (9-panel plot, etc.) or user-defined templates. Multi-layer environment allows multiple views easily accessed either by a click of the mouse or finger swipe on a touch screen device. Built-in protocol editor (graphical) to design any type of exercise protocol (for both bikes and treadmills). Comprehensive interpretation tool with powerful algorithm automatically details results and provides interpretation text strings, including numerical results.

3. Delivery: Delivery of K5 Wearable Metabolic System will be to the 6 OMRS Human

Performance Flight at MacDill AFB, FL.

4. Terms and Conditions: The K5 was developed and is manufactured by COSMED SRL, Italy, and it is sold and distributed in the US and Canada exclusively by COSMED USA Inc., 1850 Bates Avenue, Concord, CA 94520. COSMED USA, Inc. and COSMED SRL are ISO

13485 certified companies (Certificate #9594-2 and Reg. No: 387-M, respectively). Parts, repair services, and maintenance plans with rapid response for the K5are provided in the US and

Canada exclusively by COSMED USA Inc., 1850 Bates Avenue, Concord, CA 94520. The K5 is an FDA approved Class II medical device, 510(K) #K162515 and is listed in GSA Contract #GS-

24F-0067N

Sources Sought