STATEMENT OF WORK ventiliator.docx

STATEMENT OF WORK (SOW)

Hamilton-C6 Ventilator Package

1. Scope The contractor shall provide all materials, equipment, to furnish and deliver a complete ventilator package consisting of the Hamilton-C6 Ventilator system and all required accessories.

The system shall be fully functional for use in critical care environments, supporting adult, pediatric, and neonatal patients.

2. Applicable Documents & Standards The equipment shall comply with, at minimum:

· FDA 510(k) clearance for ventilator systems

· IEC 60601 (Medical Electrical Equipment Safety)

· ISO standards applicable to ventilators

· NFPA/OSHA safety requirements

· Facility biomedical and IT security standards

3. Requirements

3.1 General Requirements

The contractor shall:

· Provide new, unused, current production model equipment

· Ensure all components are fully compatible

· Deliver a complete, ready-to-use system

· Include all necessary cables, connectors, and accessories

3.2 Ventilator System Specifications

The ventilator shall meet or exceed the following minimum characteristics:

3.2.1 Patient Population

· Adult: Fully supported

· Pediatric: Fully supported

· Neonatal: Fully supported (including low tidal volume capability)

3.2.2 Ventilation Modes

The system shall include, at minimum:

· Volume-Controlled Ventilation (VCV)

· Pressure-Controlled Ventilation (PCV)

· Pressure Support Ventilation (PSV)

· Synchronized Intermittent Mandatory Ventilation (SIMV)

· Adaptive Support Ventilation (ASV)

· Non-Invasive Ventilation (NIV)

3.2.3 Advanced Ventilation Features

· Closed-loop ventilation capability (e.g., INTELLiVENT-ASV)

· Automatic adjustment of oxygenation and ventilation parameters

· Lung-protective ventilation strategies

· Recruitment maneuver capability

3.2.4 Monitoring Capabilities

The system shall provide real-time monitoring of:

· Airway pressure, flow, and volume waveforms

· Tidal volume (inspired/expired)

· Minute ventilation

· Lung compliance and resistance

· PEEP and plateau pressure

· Optional/Included:

· Pulse oximetry (SpO₂)

· Capnography (EtCO₂)

3.2.5 User Interface

· Touchscreen display (minimum 12 inches)

· Intuitive graphical interface

· Alarm system with visual and audible alerts

· Customizable display and alarm limits

3.2.6 Oxygen Therapy

· Integrated high-flow oxygen therapy capability

· Seamless transition between ventilation modes and oxygen therapy

3.3 Accessories and Components

The ventilator package shall include, at minimum:

· Ventilator cart or mounting system

· Breathing circuits (adult, pediatric, neonatal)

· Heated circuit compatibility

· Humidification system (active or passive)

· Bacterial/viral filters

· Oxygen and air supply hoses

· Power cords and backup battery

· Nebulizer system (integrated or compatible)

· Test lung for system verification

3.4 Software and Connectivity

· None

3.5 Training Requirements

The contractor shall provide:

· On-site or virtual clinical training for end users

· Biomedical/technical training for maintenance staff

· Training materials including:

· User manuals

· Quick reference guides

· Troubleshooting documentation Training shall be completed within 180 days of delivery.

3.6 Delivery Requirements

· Delivery shall occur within 60 days after award

· Equipment shall be delivered to: Hopi Health Care Centen, Hwy 264 MPP 388, Polacca, AZ 86042

· All items shall be properly packaged and protected

3.7 Installation and Setup

If required, the contractor shall:

· Assemble and install equipment

· Perform initial system configuration

· Verify operational readiness

3.8 Inspection and Acceptance

Acceptance will be based on:

· Verification of all components and accessories

· Successful operational testing

· No critical defects or deficiencies

· Completion of required training

4. Performance Requirements

5. Warranty and Maintenance

· Minimum 12-month manufacturer warranty (parts and labor)

· Technical support availability (phone/email)

· Preventive maintenance recommendations provided

· Availability of replacement parts for minimum 5 years

6. Contractor Qualifications The contractor shall:

· Be an authorized distributor or representative of the manufacturer

· Demonstrate experience with ICU ventilator systems

· Provide certified technicians (if installation/training required)

7. Deliverables The contractor shall provide:

· Fully functional ventilator system(s)

· All accessories and consumables

· Training completion documentation

· Operator and technical manuals

· Warranty documentation

8. Period of Performance

· Delivery: Within 60 days after contract award

· Training: Completed within 180 days of delivery

· Warranty: Minimum 12 months

9. Place of Performance Hopi Health Care Center, Hyw 264 MPP 388, Polacca, AZ 86042