Attachment 1 - Salient Characteristics.pdf
PDF 121 KB Posted
- Attached to
- Neonatal Transport System
- Solicitation number
- W81K0026QA207
- Issued by
-
Department of the Army Medical Command
About this file
This document is a specification sheet outlining the salient characteristics and minimum clinical performance requirements for a neonatal incubator system. The incubator must accommodate patients weighing up to 10 kg and feature a main access door measuring 21.6 x 57 cm, six oval-shaped hand ports (13 x 9 x 16.5 cm), and eight access ports for IV and respiratory tubing. The mattress dimensions are specified as 31.8 x 61.0 x 2.5 cm, with available mattress-to-chamber heights of 24.1 cm (XL) and 19.0 cm (LP). The unit must include a quick-release mechanism requiring no tools and incorporate a vibration isolation system.
The system shall feature a 17.8 cm diagonal touch screen display with 800 x 480 pixel resolution, incorporating data trending and output capabilities, stop watch, countdown timer, screen lock, and adjustable brightness (5 levels at 20% increments). Alarm functions must include temperature monitoring (chamber and patient), airflow blockage detection, AC disconnect, power fail, fan failure, low battery, system failure, air temperature sensor, and speaker failure alerts, with adjustable intensity (65 dBA maximum to 50 dBA minimum at 3 meters) and plain text messaging. Power specifications include AC input of 100–240 VAC at 50/60 Hz with 3 A maximum, total power of 2,000 VA maximum, eight AC accessory outlets at 7 A total maximum, and external DC input/output capabilities (12–28 V, 15 A input maximum; 2 A output maximum). The unit must be ISO 13485 certified and include operator training, special calibration equipment availability, and ease of maintenance and repair considerations.
View the file
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Salient Characteristics:
Minimum Clinical Performance Requirements Examples shall include if applicable but not be limited to the following:
- Main Access Door: 21.6 x 57 cm
- 6 Hand Ports: 13 x 9 16.5 cm (Oval Shape)
- 8 Access Ports for IV/Respiratory Tubin
- Mattress: 31.8 x 61.0 x 2.5 cm
- Maximum Patient Weight: 10 kg
- Mattress to Chamber Height: 24.1 cm (XL)
- Mattress to Chamber Height: 19.0 cm (LP)
- Quick Release with No Tools
- Vibration Isolation System
- Touch Screen: 17.8 cm (diagonal)
- 800 x 480 pixels* Data Trending & Output
- Stop Watch
- Countdown Timer
- Screen Lock
- Screen Brightness Adjustment: 5 (20%)
- Event Log
- Self-test function performed at power on & continuously during operation
- Adjustable Alarm Intensity: 65 dBA Max -50dBA Min @3m)
- Color Coded Visual Alarms* Alarm Messages Communicated in Plain Text
- Alarms: Chamber Temperature HI/LO (Manual Mode), Patient Temperature HI/LO
(Servo Mode), Airflow Blocked, AC Disconnect, Power Fail, Airflow Fan Fail, Low Battery, System Fail, Air Temp Senso, Speaker Fail
Secure Considerations:
- AC Power (incubator): 100 – 240 VAC, 50/60Hz, 3 A Max
- Total Power: 2,000 VA (Max)
- 8 AC Accessory Outlets: 7 A Max (Total) at input voltage
- External DC Power Input: 12 – 28 V, 15 A Max
- External DC Powe Output: 2 A, at input voltage
Biomedical Tech Considerations:
- Operator Training
- Special Calibration Equipment
- Ease of Maintenance/repair considerations
Certifications:
- ISO 13485 certified
File details come from the government source that posted it. Updated .