The file's text, extracted by GovTribe without its formatting.
Attachment 2.
The requirements listed in the table below shall be accommodated by the responder offering a complete Thornhill Medical MOVES SLC. Please indicate Y (yes) or N (No) if your system meets each requirement in the requirements list below, and use the comments column to further justify how your product meets the requirement.
| REQUIREMENTS/SPECIFICATIONS |
| MEETS REQUIRMENTS? (Y/N) |
| COMMENTS |
| 1 |
| Shall be FDA approved and designed for adult and pediatric patients between 10kg -120kg |
| 2 |
| Shall combine an oxygen concentrator, an oxygen conserving ventilator, suction, and patient monitoring system into a single compact system |
| 3 |
| Shall be designed for use in military medicine, disaster relief medical care, field hospitals, and remote environments |
| 4 |
| Shall be a single, durable, rugged device designed with a single user interface |
| 5 |
| Shall be able to operate with battery or single external power. |
| 6 |
| Shall be a circle-circuit ventilator that allows a high FiO2 percentage with low flow O2. It must not need high-pressure oxygen cylinders to deliver oxygen. |
| 7 |
| The portable ventilator shall be computer-controlled and electrically powered. It must be able to provide continuous or intermittent ventilator support. It must deliver up to 85% independent of minute ventilation for cyclic mode ventilation and greater than 85% independent of minute ventilation for continuous mode ventilation. |
It must be able to provide the following ventilation modes:
· IMV
· SIMV
· SIMV+PS
· AC
· PSV
| 8 |
| The system shall be able to deliver supplemental oxygen without invasive ventilator support. It must deliver up to 93% in concentrated breathing gas at 2.5 liters per minute (LPM) |
| 9 |
| The portable suction pump shall be designed for aspiration and removal of fluids, tissue (to include bone), gases, bodily fluids, or infectious materials from wounds, airways, or respiratory support system. It must achieve 100-325 mmHg of suction. |
| 10 |
| The patient monitor shall trend physiological parameters up to 24 hours and display the parameters for care providers to interpret. The SpO2 must utilize Masimo brand. The system must display: |
· FiO2
· ETCO2 & Capnography
· ABP
· CVP
· ICP
· NIBP
· SpO2
· 12 Lead ECG
· Patient Temperature
| 11 |
| The system shall not weigh more than 17kg (37lbs) excluding batteries and clamps |
| 12 |
| It shall be the following dimension: |
· 84 cm (33″) L x 14 cm (5.5″) W x 25cm (10″) H
| 13 |
| The system shall be constructed of aluminum |
| 14 |
| The system shall be able to with stand temperatures between -26°C to 54°C (-15°F to 129°F) |
| 15 |
| Water ingress shall meet IPX4: resistant to water splashes from any direction |
| 16 |
| Humidity standard shall be able to withstand 15% – 95%, relative humidity, non-condensing |
| 17 |
| Shall be able to operate at an altitude level between 0-5.5 km or 0-18,000 feet |
| 18 |
| Shall meet vibration standards that have undergone MIL-STD-810G and US Army Joint En route Care Equipment Test Standard (JECETS) for rotary-wing, fixed wing and jet aircraft as well as ground transportation vehicles |
| 19 |
| The power source shall be between 100-240V AC 50/60Hz or battery power |
| 20 |
| The battery shall weight 1.5kg or 3.3 pounds, be lithium polymer, and deliver a minimum of 2.5 hours/ set of 2 and typically up to 6 hours/ set of 2 Typical: up to 6 hrs. / set of 2. Minimum: 2.5 hrs / set of 2. |
| 21 |
| It shall offer hands-free options with optional ruggedized tablets |
| 22 |
| It shall be able to connect to varying military litters or offer adaptors to allow this to happen. |
| 23 |
| It shall offer an optional sturdy pole capable of hanging solutions or equipment |
| 24 |
| It shall include supplemental and peripheral accessories for operation and use |
| 25 |
| The system shall be able to deliver supplemental oxygen without invasive ventilatory support. It must deliver up to 93% in concentrated breathing gas at 2.5 liters per minute (LPM) |
- 4 -
Department of the Army Medical Command