GE Healthcare enFlow IV Fluid and Blood Warmer - Booklet - Manual (Page 6)

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enFlow IV Fluid/Blood Warmer System
Warmer 13 cm x 6 cm x 3 cm (5.0 in. x 2.5 in. x 1.2 in.)
Controller 23 cm x 15 cm x 9 cm (9.0 in. x 6.0 in. x 3.8 in.)
Disposable Cartridge 11 cm x 4 cm x 1 cm (4.5 in. x 1.5 in. x 0.4 in.)
Weight
Warmer: (w/o Disposable): 279 g (9.8 oz.)
Controller: 1.8 kg (3.9 lb.)
Disposable Cartridge: 33 g (1.2 oz.)
Performance Detail
Disposable cartridge priming volume 4 mL
Disposable cartridge sterility Gamma Sterilized
Fluid Temperature Output 40 °C ± 2 °C
Flow Rate Range KVO to 200 mL/min
Input Voltage
Warmer: 28 VDC at a maximum of 300 Watts
Controller: 110-120 or 220-240 VAC 47 – 63 Hz
Temperature Set Point 40 °C
Input Current 5 A
Environmental/Physical Requirements
Temperature, Operating -5 °C to 50 °C
Temperature, Storage -30 °C to 70 °C
Relative Humidity, Operating and Storage
Warmer: 10% to 90%
Controller: 10% to 90%
Disposable Cartridge: 10% to 90%
Altitude, Operating and Storage Up to 4,572 m (15,000 ft.)
Air Pressure, Operating and Storage 570 hPa, (17 in. Hg) to 1,060 hPa (31 in. Hg)
Compliance with Standards
Biocompatibility Disposable Cartridge: ISO 10993
Infusion Set Compatible Disposable Cartridge: ISO 8536-4
Over Temperature Set Point ASTM F-2172-02
Alarms IEC60601-1-8
Water Resistance
Warmer: IEC 529 IP67 30 minutes immersion at a depth of 91.4 cm (36 in.)
Controller: IEC 529 IP21 dripping water
Disposable Cartridge: IEC 529 IP68 continuous immersion
Penetration
Warmer: IEC 529 IP67 dust tight
Controller: IEC 529 IP21 ≥ 12.5 diameter against ingress of solid foreign bodies
Disposable Cartridge: IEC 529 IP68 dust tight
Electrical Safety
UL 60601-1:2005 R6.03, CAN/CSA-C22.2 No. 60601.1:2008, IEC 60601-1-6:2010, AAMI
ES60601-1:2005, IEC 60601-1-4:2000 (Canada)
Shock/Drop Abuse Tolerance MIL-STD-810F
Vibration MIL-STD-810F
Electromagnetic Emissions CISPR11 Group 1 Class A
Electromagnetic Immunity IEC61000-4-3 Level 3, 10 V/M
Magnetic Field Immunity IEC61000-4-8 Level 2, 3 A/M
Electrostatic Discharge IEC61000-4-2 Level 4, 8 kV Contact, 15 kV Air
Safety Classifications
Type of protection against electrical shock Class I or Internally Powered
Degree of protection against electric shock Type BF, Defibrillation-Proof
Mode of operation Continuous
References
1. Young, V. Watson, M. Prevention of Perioperative Hypothermia in
Plastic Surgery. Aesthetic Surgery Journal. 2006; 551-571.
2. NICE (National Institute for Clinical Excellence) Inadvertent
perioperative hypothermia: full guideline (April 2008).
3. Lenhardt R, Marker E, Goll V, Tschernich H, Kurz A, Sessler DI, Narzt E,
Lackner F. Mild intraoperative hypothermia prolongs postanesthetic
recovery. Department of Anesthesia, University of California, San
Francisco 94143-0648, USA. Anesthesiology. 1997 Dec; 87 (6):1318-23.
4. Sessler, Daniel I. MD: Mild Perioperative Hypothermia. New
England Journal of Medicine. 336 (24):1730 1737, June 1997.
5. Charles E. Smith, MD, FRCPC, Erik Gerdes, Susan Sweda, MD, et al.
Warming Intravenous Fluids Reduces Perioperative Hypothermia
in Women Undergoing Ambulatory Gynecological Surgery. Anesth
Analg 1998; 87:37-41.
Smith CE, Gerdes E, Sweda S, Myles C, Punjabi A, Pinchak AC,
Hagen JF. Warming Intravenous Fluids Reduces Perioperative
Hypothermia in Women Undergoing Ambulatory Gynecological
Surgery. Anesth Analg 1998; 87 (1):37-41.
Frank Lista, MD, Chris D. Doherty, MD, Richard M. Backstein, MD,
and Jamil Ahmad, MD. The Impact of Perioperative Warming in an
Outpatient Aesthetic Surgery Setting. Aesthetic Surgery Journal
July 2012 vol. 32 no. 5 613-620.
6. Ochsner J. 2011 Fall; 11 (3):259-70. Unintended perioperative
hypothermia. Hart SR, Bordes B, Hart J, Corsino D, Harmon D.
7. Sessler, Daniel I. MD: Mild Perioperative Hypothermia. New
England Journal of Medicine. 336 (24):1730 1737, June 1997.
8. Incidence and timing of hypothermia in trauma patients.
Gregory JS, Flancbaum L, Townsend MC, Cloutier CT, Jonasson O
Department of Surgery, Ohio State University, Columbus 43210.
The Journal of Trauma [1991, 31 (6):795-8; discussion 798-800].
9. Mahoney, Christine Brown, RN, PhD, MS & Odum, Jan RN, MS,
COPAN, FAAN; Maintaining intraoperative normothermia: A
metaanalysis of outcomes with costs. AANA Journal, April 1999,
Vol. 67, No 2. 155-164.
Sessler, Daniel I. MD: Mild Perioperative Hypothermia. New
England Journal of Medicine. 336 (24):1730 1737, June 1997.
10. Lenhardt R, Marker E, Goll V, Tschernich H, Kurz A, Sessler DI,
Narzt E, Lackner F. Mild intraoperative hypothermia prolongs
postanesthetic recovery. Department of Anesthesia, University of
California, San Francisco 94143-0648, USA. Anesthesiology. 1997
Dec; 87 (6):1318-23.
11. Young, V. Watson, M. Prevention of Perioperative Hypothermia in
Plastic Surgery. Aesthetic Surgery Journal. 2006; 551-571.
12. Anesthesiology. 1993 Mar; 78 (3):468-76. Unintentional
hypothermia is associated with postoperative myocardial
ischemia. The Perioperative Ischemia Randomized Anesthesia
Trial Study Group. Frank SM, Beattie C, Christopherson R, Norris EJ,
Perler BA, Williams GM, Gottlieb SO.
JAMA. 1997 Apr 9; 277 (14):1127-34. Perioperative maintenance
of normothermia reduces the incidence of morbid cardiac events.
A randomized clinical trial. Frank SM, Fleisher LA, Breslow MJ,
Higgins MS, Olson KF, Kelly S, Beattie C.
13. Am Surg. 1999 Dec; 65 (12):1193-6.
-- Hypothermia reduces resistance to surgical wound infections --
Sessler DI, Kurz A, Lenhardt R. Sessler, Daniel I. MD: Mild
Perioperative Hypothermia. New England Journal of Medicine.
336 (24):1730, June 1997.
Estimating Health Care-Associated Infections and Deaths in U.S.
Hospitals, 2002, Public Health Reports/March–April 2007/Volume
122 P. 160-166.
14. Mahoney, Christine Brown, RN, PhD, MS & Odum, Jan RN, MS,
COPAN, FAAN; Maintaining intraoperative normothermia: A
metaanalysis of outcomes with costs. AANA Journal, April 1999,
Vol. 67, No 2. 155-164.
Sessler, Daniel I. MD: Mild Perioperative Hypothermia. New
England Journal of Medicine. 336 (24):1730 1737, June 1997.