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4400-0024-EN Rev A

Appendix A: Technical specications

Size 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)

Weight 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 (and optional IV extension set):

Priming Volume Disposable Cartridge: 4 mL

(Optional IV extension set): 0.5 mL

Sterility Gamma Sterilized

Biocompatibility ISO 10993

Infusion Set Compatible ISO 8536-4

Performance:

Fluid Temperature Output 40 °C ± 2 °C

Flow Rate Range KVO (2 mL/min) - 200 mL/min

Input Voltage Warmer: 28.5 VDC at a maximum of 350 Watts

Controller: 100-240 VAC

Temperature Set Point 40 °C

Over Temperature Set Point ASTM F-2172-02

Alarms IEC60601-1-8:2006

Max Input Current 5 A

Input Frequency Range Warmer: DC

Controller: 47-63 Hz

Environmental/Physical Requirements:

Temperature, Operating -5 °C to 50 °C

Temperature, Storage -30 °C to 70 °C

Water Resistance 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

Penetration 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

Electrical Safety 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.

Relative Humidity, Operating and Storage Warmer: 10% to 90%

Controller: 10% to 90%

Disposable Cartridge (and optional IV extension set): 10% to 90%

Altitude, Operating and Storage Up to 15,000 ft

Air Pressure, Operating and Storage 570 hPa, (17 inHg) to 1060 hPa (31 inHg)

Radiated Magnetic Field Emissions EMC IEC 60601-1-2:2014

Safety Classications:

Type of protection against electrical shock Class I, or Internally Powered

Degree of protection against electric shock Type BF, Debrillation-Proof

Mode of operation Continuous

Note: Electromagnetic Compatibility (EMC)

The enFlow IV uid/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.