Appendix A: Technical Specifications - GE enFlow IV System Manual

Appendix A: Technical specifications

Size
Weight
Disposable Cartridge (and optional IV extension set):
Priming Volume
Sterility
Biocompatibility
Infusion Set Compatible
Performance:
Fluid Temperature Output
Flow Rate Range
Input Voltage
Temperature Set Point
Over Temperature Set Point
Alarms
Max Input Current
Input Frequency Range
Environmental/Physical Requirements:
Temperature, Operating
Temperature, Storage
Water Resistance
Penetration
Electrical Safety
Relative Humidity, Operating and Storage
Altitude, Operating and Storage
Air Pressure, Operating and Storage
Radiated Magnetic Field Emissions
Safety Classifications:
Type of protection against electrical shock
Degree of protection against electric shock
Mode of operation
Note: Electromagnetic Compatibility (EMC)
The enFlow IV fluid/blood warming system has been tested and found to comply with the limits for medical devices as set forth in IEC 60601-1-2: (2014)
and related standards. These limits are designed to provide reasonable protection against electromagnetic interference (EMI) in a typical medical installation.
The enFlow system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause
interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation.
4400-0024-EN Rev A
Warmer: 12.7 cm L x 6.6 cm W x 3.0 cm H (5.0 in L x 2.6 in W x 1.75 in H)
Controller: 23.6 cm L x 16.8 cm W x 9.7 cm H (9.3 in L x 6.6 in W x 3.8 in H)
Disposable Cartridge: 11.4 cm L x 3.8 cm W x 1.0 cm H (4.5 in L x 1.5 in W x 0.4 in H)
Extension set: 121 mm L x 10.6 mm W (4.7 in L x 0.4 in W)
Warmer (w/o disposable): 330 g (11.6 oz)
Controller: 1.9 kg (4.2 lb)
Disposable Cartridge: 33 g (1.2 oz)
Extension set: 2 g (0.07 oz)
Disposable Cartridge: 4 mL
(Optional IV extension set): 0.5 mL
Gamma Sterilized
ISO 10993
ISO 8536-4
40 °C ± 2 °C
KVO (2 mL/min) - 200 mL/min
Warmer: 28.5 VDC at a maximum of 350 Watts
Controller: 100-240 VAC
40 °C
ASTM F-2172-02
IEC60601-1-8:2006
5 A
Warmer: DC
Controller: 47-63 Hz
-5 °C to 50 °C
-30 °C to 70 °C
Warmer: IEC 529 IP67 30 minutes immersion at a depth of 91.4 cm (36 in)
Controller: IEC 529 IP31 dripping water
Disposable Cartridge (and optional IV extension set): IEC 529 IP68, (IV extension set): IEC 529 IP68 continuous
immersion
Warmer: IEC 529 IP67 dust tight
Controller: IEC 529 IP31 ≥ 2.5 mm diameter
Disposable Cartridge (and optional IV extension set): IEC 529 IP68 dust, (IV extension set): IEC 529 IP68 dust
tight
CAN/CSA-C22.2 No. 60601-1:2008 Ed 03, AAMI ES60601-1:2005, IEC 60601-1:2005 Ed 03, IEC 60601-1 -6:2010
Ed 3 and IEC 60601-1-8: 2006 Ed 2.
Warmer: 10% to 90%
Controller: 10% to 90%
Disposable Cartridge (and optional IV extension set): 10% to 90%
Up to 15,000 ft
570 hPa, (17 inHg) to 1060 hPa (31 inHg)
EMC IEC 60601-1-2:2014
Class I, or Internally Powered
Type BF, Defibrillation-Proof
Continuous
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