SON Infant Warmer.docx

Statement of Need Eastern Colorado HealthCare System Rocky Mountain Regional VA Medical Center

Infant Warmer for Women’s Health

1. Background

1.1 Neonatal patients—especially preterm and critically ill newborns—are vulnerable to hypothermia, respiratory compromise, infection, and challenges related to family integration and workflow.

1.2 Providing safe and effective neonatal care requires integrated, advanced equipment supporting all facets of open care: temperature regulation, airway management, monitoring, workflow efficiency, infection prevention, and family-centered initiatives.

2. Identified Need

2.1 Uniform, automatic thermal management including mattress options.

2.2 Integrated, advanced respiratory support and gas mixing.

2.3 Comprehensive patient monitoring and data integration.

2.4 Workflow support for labor and delivery, NICU, and transport.

2.5 Family-centered care and alarm management including kangaroo care.

2.6 Infection prevention and disposable components.

2.7 Ergonomic access, ample storage, and device mobility.

2.8 Reliable, vendor-trained preventive maintenance and support.

3. Salient Characteristics (Including All Options and Accessories)

3.1 Thermal Management:

3.1.1 Dual radiant heating elements for even, stable heat delivery.

3.1.2 Central and peripheral sensors for skin temperature regulation.

3.1.3 Mattress with viscoelastic foam core for comfort and protection of sensitive skin.

3.1.4 Heated Gel Mattress to provide a secondary heat source to further reduce risk of heat loss.

3.2 Respiratory Support:

3.2.1 Included Gas mixer with auxiliary adapter and T-piece.

3.2. Provides automated delivery of precise FiO2, flow, pressure, respiratory rate, and PEEP (Positive End-Expiratory Pressure).

3.2.3 Compatible with Disposable Breathing Circuits sized for neonates and single use for infection prevention.

3.2.4 Compatible with neonatal masks in multiple sizes for anatomical fit and sealing.

3.3 Monitoring Integration:

3.3.1 Provides continuous bedside-to-transport monitoring with real-time ECG, SpO2, and vital signs.

3.3.2 Monitor integrates with hospital clinical information systems and data applications.

3.3.3 APGAR Timer and Preductal SpO2 Reference Chart are synchronized for rapid assessment.

3.4 Weighing and Workflow Solutions:

3.4.1 Integrated Smart Scale allows accurate weighing during mattress tilt, automatic weight adjustments, trends, and daily weights documented.

3.4.2 Color Touchscreen offers configurable interface for labor/delivery, NICU, and family view.

3.4.3 Bed-Tilt Indicator provides precise bed angulation to support protocols for feeding, IVH, and stimulation minimization.

3.4.4 Ergonomic Storage includes single or dual swivel drawers, instrument tray, and additional storage options for clinical supplies and tools.

3.4.5 Height Adjustable Trolly to easily raise or lower unit.

3.5 Family-Centered Care and Alarm Management:

3.5.1 Dedicated function to support skin-to-skin care with reduced nuisance alarms and documentation of bonding sessions.

3.6 Device Mobility and Gas Support:

3.6.1 Two Gas Cylinder Holder has quick release for oxygen and air cylinders with an integrated protection bar to prevent regulator damage.

3.7 Infection Prevention:

3.7.1 Smooth, easy-to-clean surfaces have minimal gaps for optimal cleaning.

3.7.2 Disposable Breathing Circuits and Single-Use Accessories reduce cross-contamination and reprocessing burden.

3.8 Temperature Sensor and Data Functionality:

3.8.1 Temperature Sensors to identify thermal stress detection with numeric and graphical display.

3.9 X-Ray Tray

3.9.1 Tray is compatible with film, imaging plates, or digital detectors for on-bed imaging:

3.10 Service and Maintenance:

3.10.1 Comprehensive manufacturer-supported preventive maintenance, inspections, and quick original part replacement.

3.10.2 Full device documentation and test history management.

4. Operating Ranges and Technical Specifications:

4.1 Environment and Operation:

4.1.1 Operating Ambient Temperature is 64–95 °F (18–35 °C).

4.1.2 Operating Ambient Pressure without Resuscitation Module is 9.0–15.4 psi (620–1,060 hPa).

4.1.3 Operating Ambient Pressure with Resuscitation Module is 10.0–15.4 psi (690–1,060 hPa).

4.1.4 Operating Relative Humidity is 20–95%, non-condensing.

4.2 Storage and Transport:

4.2.1 Storage and Transport Temperature is –4 to 140 °F (–20 to 60 °C).

4.2.2 Storage and Transport Pressure is 7.3–16.0 psi (500–1,100 hPa).

4.2.3 Storage and Transport Relative Humidity is 10–95%, non-condensing.

4.3 Power and Gas:

4.3.1 Main Power operates at 100–240 V, 50/60 Hz, up to 10 A/1000 W.

4.3.2 O₂ and Air Input operate at 2.7–6.0 bar (39–87 psi or 270–600 kPa).

4.4 Patient Interface and Bed:

4.4.1 Maximum Patient Weight is 22 lbs (10 kg).

4.4.2 Bed Tilt is continuous up to 15° both directions, with tactile stops at 0°, ±10°.

4.4.3 Heated Gel Mattress dimensions are 19.1 x 29.3 in (485 x 745 mm).

4.4.4 Mattress dimensions are 18.5 x 29.5 in (470 x 750 mm).

4.4.5 Device Height is adjustable from 70.87 to 86.61 in (1,800–2,200 mm).

4.4.6 Device Weight is less than 308.6 lbs (140 kg, without options/accessories).

4.4.7 Operating Noise is less than or equal to 40 dB(A), and less than or equal to 60 dB(A).

4.5 Performance:

4.5.1 Skin Temperature Set Range is 93.2–100.4 °F (34–38 °C).

4.5.2 Skin Temperature Measuring Range is 55.4–109.4 °F (13–43 °C).

4.5.3 Heated Gel Mattress Temperature Range is 86–101.3 °F (30–38.5 °C).

4.5.4 Radiant Heater Setting Range is Off, 10–100%, with Pre-warm mode at 100% for 3 min, 60% for 11.5 min, 30% thereafter.

4.5.5 Scale Range is 0.44–33.1 lbs (200–15,000 g), with 1 g resolution,

4.5.6 Gas Mixer is adjustable 21–100% O₂, ±5% of full scale,

4.5.7 X-ray Compatibility includes film at 7 x 9 in (18 x 24 cm), imaging plate at 9 x 12 in (24 x 30 cm), and digital up to 13 x 15 in (34 x 38 cm), thickness ≤1 in (2.25 cm),

4.5.8 APGAR Timer and Integrated Monitoring Features,

5. Delivery

5.1. Delivery Location:

5.1.1.1. Rocky Mountain Regional VA Medical Center

5.2. Delivery Times:

5.2.1 The loading dock is open Monday-Friday from 0700-1500 hours excluding all Federal Holidays and any other day specifically declared a National Holiday by the President of the United States.

5.2.1. Federal Holidays are currently identified as:

· New Year’s Day

· Dr. Martin Luther King Jr’s Birthday

· Presidents’ Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veteran’s Day

· Thanksgiving Day

· Christmas Day