6515--Artic Sun Stat Temperature Management

The Martinsburg VA Medical Center is conducting this Sources Sought to identify contractors who possess capabilities to provide the product described in the specification below. As permitted by the FAR Part 10, this is a market research tool being utilized for the informational and planning purposes. Your responses will assist the Government in the development of its acquisition strategy. Response is strictly voluntary it is not mandatory to submit a response to this notice to participate in formal RFQ process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence our acquisition strategy. All interested parties will be required to respond separately to any solicitation posted because of this sources sought notice. Respondents will not be notified of the results of the evaluation. We appreciate your interest and thank you in advance for responding to the sources sought. This service will be implemented using the North American Industry Classification System (NAICS) Code 339112. NOTES All Capability Statements/Responses to this Sources Sought Notice shall be submitted via email only to joseph.krupa@va.gov. Telephone, Fax, or any other form of communication inquiries will not be reviewed or accepted. Responses to this Sources Sought Notice must be received no later than June 19, 2023, at 3:00 p.m. (Eastern Standard Time). This Sources Sought Notice may or may not assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued, it may or may not be announced later, and all interested parties shall respond to that solicitation announcement separately from the responses to this Sources Sought Notice. DISCLAIMER This RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked a proprietary will be handled accordingly in accordance with (IAW) Federal Acquisition Regulation (FAR), RFIs may be used when the Government does not presently intend to award a contract, but wants to obtain price, delivery, other market information, or capabilities for planning purposes. Responses to these notices are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses incurred associated with responding to this RFI. Specifications: 1 Arctic Sun Stat Temperature Management System 1   - Standard Product Warranty (one year)     - Service Kit (sent to Biomed)     - Multiple-Protocol Selection     - Wifi Capability (we will not be utilizing this feature)     - Product training and education (upon device delivery)     - 24/7 Clinical/Technical Support     One Year Arctic Sun Analytics Subscription 1   ArcticGel Universal Pad Case 1   ArcticGel Small Kit 1   ArcticGel Large Kit 1 TECHNICAL DESCRIPTION The Arctic Sun Temperature Management System is a thermoregulatory device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). A patient temperature probe connected to the Control Module provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun Temperature Management System pulls temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel pads. This results in heat exchange between the water and the patient. The Arctic Sun Temperature Management System Control Module is a Class I mobile device (Type BF, IPX0 and Mode of Operation Continuous) per classification scheme of IEC 60601-1. The Arctic Sun Temperature Management System Control Module meets both the electromagnetic interference and susceptibility requirements of IEC 60601-1, and is compatible with other equipment that also conforms to that standard. There is no known failure mode in the Arctic Sun Temperature Management System Control Module associated with electromagnetic interference from other devices. INDICATIONS FOR USE The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages. Equipment/Supply/Instrument Dimensions Height: 41 inches (104 cm) Width: 16 inches (41 cm) Depth: 20 inches (51 cm) Weight Filled: 55.3 kg/122 lbs Dimensions (what is the space requirement for the product?): Patient Temperature Display Range 10°C to 44°C/50°F to 111.2°F 0.1°C/°F increments Display/Monitor/Screen (If required): Additional display requirements,_______None Software Required/associated with this purchase? No Power Requirements? Yes X No________ Hours to Recharge: From To_______ Mains Input 120VAC 60Hz 11Amp Total Patient Leakage Current (Normal Condition) <300 A Heater Maximum Power 814 Watts Operating hours: From ____To____________ Environmental Considerations: Yes ____X___No______ Heating/Cooling range from See Table Below To ________________ Other Environmental Considerations: Patient Temperature Control Range 32°C to 38.5°C/89.6°F to 101.3°F 0.1°C/°F increments Water Temperature Display Range 3°C to 45°C/37.4°F to 113.0°F 0.1°C /°F increments Water Temperature Control Range (Manual) 4°C to 40°C 1°C increments High Water Temperature Limit 36°C to 40°C 1°C increments Low Water Temperature Limit 4°C to 25°C 1°C increments Time to heat water from 25°C to 40°C <15 minutes Time to lower water temperature from 25°C to 7°C <15 minutes Sound Pressure Low Priority Alarm: 64-71dB at 1 meter Medium Priority Alarm: 64-71dB at 1 meter Reminder Tone: 65dB at 3 meters Responses of the PCLCS (Physiologic Closed-Loop Control System) Settling Time: ~4.5 hours Relative Overshoot: <0.5°C Command Overshoot: <0.5°C Warming (max) Response Time: 32°C to 37°C/89.6°F to 98.6°F: ~8.5 hours Cooling Response Time: 37°C to 33°C/98.6°F to 91.4°F: ~2 hours Steady State Deviation: 0 Tracking Error: 0 Note: All values derived from testing in simulated use Environmental Conditions At operating temperatures higher than 27°C (80.6°F), the refrigeration system s cooling capacity and therefore its ability to cool a patient is compromised. If the Control Module is to be exposed to subfreezing temperatures, perform the Total Drain process. Disposal Upon end of life, dispose of in accordance with local WEEE regulations or contact your local BD Supplier or Distributor to arrange for disposal. Working Volume/ Product Performance/Additional requirements: (Example - How many per hour/minute) Parameter Specification Therapy Modes Normothermia: Control Patient, Rewarming Hypothermia: Cooling, Rewarming Heater Maximum Power 814 Watts Circulating Fluid Sterile Water with Cleaning Solution Average Reservoir Capacity 3.5 liters Patient Probe Type YSI 400 Series compatible Control Module The Arctic Sun Temperature Management System Control Module is the main component of the Arctic Sun Temperature Management System. It incorporates the system electronics, hydraulics, software, and the touch-screen Control Panel. The power cord, fluid delivery line, patient temperature in cables, patient temperature out cable and fill tube connect to the rear of the Control Module. Accessories/Consumables: Yes ____X___No__ If yes what? The ArcticGel Pads are an integral component of the Arctic Sun Temperature Management system. They are designed to help you deliver targeted temperature management within a narrow range for all appropriate patients. With patented hydrogel technology, the ArcticGel Pads are a non-invasive solution that helps achieve precise core temperature control The ArcticGel Pad s proprietary hydrogel provides constant contact with skin throughout therapy The ArcticGel Pads offer a comprehensive portfolio for any size patient neonatal to adult The pads have a 2 year shelf life. Warranty and Parts/Service Requirements: Minimum Warranty Months/Years___x___1 year minimum Parts/Service/Support options: ___x_____1 year minimum Cleaning Instructions (If sterilization is required): Additional instructions/Needs/Specifications: No other needs or instructions. __X___Power Cord must be hospital grade Other pertinent information that describes the item, material or service needed: Main Safety Alarms While there are multiple alarms and safety features in the Arctic Sun Temperature Management System, there are five main safety alarms that will place the device into Stop mode until the condition is addressed. Alarm Specification High Patient Temperature 39.5°C (103.1°F) Low Patient Temperature 31.0°C (87.8°F) High Water Temperature 42.5°C / 44°C (108.5°F / 111.2°F) Low Water Temperature 3.0°C / 3.5°C (37.4°F / 38.3°F) System Self-Test Failure At device Power On If this is replacement equipment, original equipment, original manufacturer, and manufacturer part number if known: NA