Attachment 1 - Specifications.pdf

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Attached to
Ultra Low Temperature Medical Grade Freezer
Solicitation number
FA524021Q0002
Issued by

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This document contains specifications for an ultra-low temperature medical grade freezer solicitation from the Department of the Air Force Pacific Air Forces. The solicitation requests quotes by July 1, 2021 at 1200 PM EST for the supply of 77 ultra-low temperature medical grade freezers from the manufacturer B-Medical Systems, including 14 units of model U701 and 63 units of model U401, according to the attached specifications. Shipping is required to Haiphong Port in Vietnam. The freezers must meet the specifications in the Attachment 1 document, which provide details on dimensions, capacities, temperatures, sensors, alarms, certifications, and other technical requirements. This is an urgent requirement under 10 USC 2304(c)(2).

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Text version

Mode: U401 - Qty 63 Model: U701 - Qty 14

451 / 434 747 / 720

Vials 30000 (2ml) 50000 (2ml)

Cryoboxes 345 (model H50) 575 (model H50)

Plasma Bags 300 (350ml) 500 (350ml)

1 h 18 min. 1 h 18 min.

1988 x 699 x 1039 1988 x 992 x 1039

1370 x 447 x 713 1370 x 740 x 713

250 297

230 - 220 230 - 220

50 - 60 50 - 60

2000 - 2000 2000 - 2000

9.1 - 12.5 11.9 -13.5

326 - 405 426 - 511

46 - 44 50 - 55

49 - 49 48 - 48

Inner body / door

Outer body / door

Separate interiod doors

Shelf

Power cord needs to have two round pins in a flat plug as this are the most common type of outlets in Vietnam.

PT1000, from -80°C to -180°C at 0°C ± 0.1°C

PT1000, from -80°C to -180°C at 0°C ± 0.1°C

Power indicator light and digital temperature indicator (display: 0.1 digits)

Self-contained alarm system with integrated battery to take over alarm function and temperature value measurements in case of system failure for at least 48 hours

Acoustic and visual alarm signal in case of temperature alarm and system failure

Remote transmission alarm signal (via potential-free contact) in case of temperature alarm (change-over contact)

Door opening alarm (visual / acoustic)

Designed and tested for climatic class SN (ambient temperature range +10°C to +32°C)

Interior made from stainless steel

Safety Standards

Additional Requirements

77-82 mm PU with 20-30 mm VIP

Stainless steel (1.4301)

DX51D + Z100 coated Material

Anodized aluminium

Class ISO 5 / EC GMP A

Stainless steel (1.4301)

MDR (EU) 2017/745, Class IIa (models: 230 V - 50 Hz)

2014 / 30 / EU (models: 230 V - 50 Hz)

2014 / 35 / EU (models: 230 V - 50 Hz)

S p e c i f i c a t i o n s

Frequency (Hz)

Power (W)

Energy Consumption (kWh/24h)

Heat Emission (Kcal/h)

Relative humidity at +32°C

21CFR Part 864.9700, Class II (models: 220 V - 60 Hz)

Yes (models: 220 V - 60 Hz)

12 V - 7 AH / 48h

≤ 75%

65-82 mm PU with 20 mm VIP

G e n e r a l

F e a t u r e s Net weight with standard equipment (kg)

Supply Voltage (V)

Hold over time (-80°C to -60°C)

External dimensions H x W x D (mm)

Inner dimensions H x W x D (mm)

Gross / Net volume (l)

Storage Capacity

E n e r g

S a v e r

7’’ full touchscreen display

Ergonomic handle open/close - heavy duty door lock mechanism

Integrated pressure release valve

Separate interior doors in order to minimize the loss of cold air - Qty 2

ST-Shelf - Qty 3

Ethernet interface

Potential-free alarm contact in case of system failure

Integrated port for external sensor

Smooth castors with stabilizers - Qty 4

Door hinge Right | Left cCSAus certificate

GMP - Clean room classification

Mfr: B-Medical Systems

General Equipment

Door insulation (polyurethane)

Cabinet insulation (polyurethane)

European Medical Device Regulation

EMC directive

Low voltage directive

FDA regulation | Medical Device

Compressor Running Time (%)

Noise Level (dB(A))

(at 1m height & 1m distance)

Regualtion Sensor

Display Sensor in reference body / 100ml DOW corning 200-5CST (Silicon Oil)

Accu data / fucntion time of the control panel when system faillure

File details come from the government source that posted it. Updated .