Summary Maintenance of normothermia is crucial to avoid patient morbidity. Newly released fluid warming devices have become smaller in size, but this change might impair efficacy. We performed an evaluation of the buddy lite™ and enFlow™ fluid warmers. We measured inflow and outlet temperatures of the devices at flow rates between 25 and 100 ml.min −1 using saline at room temperature or cooled to 10 °C. At a flow rate of 25 ml.min −1, the outlet temperature of the buddy lite was significantly higher than that of the enFlow (p. Mean temperature measured at different points along the infusion line. (a) buddy lite, saline at room temperature (b) enFlow, saline at room temperature (c) buddy lite, cooled saline (d) enFlow, cooled saline.
Error bars are SD. ♦ 25 ml.min −1, device off, ● 25 ml.min −1, ■ 50 ml.min −1, ▲ 75 ml.min −1, ▼ 100 ml.min −1. When cooled saline was used, the solution entered the devices at a mean (SD) temperature of 10.9 (1.9) °C. Temperatures were lower at higher flow rates, such that the inlet temperature at a flow of 25 ml.min −1 was 12.3 (0.1) °C for the buddy lite and 12.1 (0.1) °C for the enFlow, whereas at a flow of 100 ml.min −1, the inlet temperature dropped to 8.3 (1.1) °C for the buddy lite and 9.1 (0.4) °C for the enFlow. Control measurements at a flow rate of 25 ml.min −1 with the device switched off revealed that the fluid warmed up passively along the outflow line, from 12.3 (0.1) °C at the device inlet to 13.8 (0.1) °C after 1 m with the buddy lite and from 12.1 (0.1) °C to 13.4 (0.2) °C with the enFlow. At a flow rate of 25 ml.min −1, the outlet temperature of the buddy lite with the device on was significantly higher than that of the enFlow (p 39 °C at the lower infusion rates of 25–50 ml.min −1 but not at 75 ml.min −1, although the latter is within the recommended flow rate.
Although an outlet temperature of 36.6 °C achieved by the buddy lite at 75 ml.min −1 flow rate is better than no fluid warming at all, it is not sufficient to maintain normothermia for prolonged periods, especially with an operating room temperature of around 20 °C. Frank and colleagues found incidences of postoperative cardiac events of 6.3% and 1.4% in two groups of patients that had mean core temperatures of 35.4 °C and 36.7 °C, respectively , indicating that even small body temperature differences may have crucial effects on patient outcome. Administering intravenous fluid at an infusion rate of 4 ml.kg −1.h −1 (i.e.
300 ml.h −1 for a 75-kg patient) is advantageous in abdominal surgery in reducing postoperative morbidity. The buddy lite is able to administer adequately warmed fluid at an infusion rate of 300 ml.h −1 or 5 ml.min −1, and is thus appropriate in operative settings without danger of major blood loss. However, limited heating performance at higher flow rates is even more pronounced when using cooled fluid such as during packed red blood cell transfusion.
The enFlow device is capable of warming both room temperature- and cooled fluid at all the flow rates tested, making it a more flexible device for the operating theatre setting. Tubing length has a profound influence on the fluid temperature entering the patient. Double-walled infusion lines with coaxial flow around the infusate maintain the warming effect along the length of the tubing. These two devices use normal tubing that is more convenient for cramped work spaces or patient transport, but there is an effect of heat loss with increasing distance from the device. This was statistically significant, although possibly not clinically significant. The major advantage of both systems is their small size and their ability to be placed close to the patient. A further advantage of the buddy lite is that it can be run using batteries that last for several hours, while the enFlow system needs a mains power supply.
The buddy lite is therefore ideal for interventions or transport in cramped working environments where there is no need for high fluid infusion rates. Due to its cartridge design, the tubing line can be shortened to less than 1 m. Further details concerning handling, usage and costs can be found in a market review from the NHS Centre for Evidence-based Purchasing.
Our study had some methodological limitations including using four fixed flow rates, whereas in clinical practice, flow rates vary continuously. Nevertheless, the lowest flow rate used in this study was above 4 ml.kg −1.h −1 for a patient of average weight. We detected a flow-dependent difference in inlet solution temperatures when using cooled fluid.
However, this difference in temperature in our laboratory setting mimics the clinical situation when cooled fluids, usually packed red blood cells, arrive in the operating theatre at different temperatures depending on transport times and delays before administration. In conclusion, both devices are capable of warming fluid at low flow rates. However, at higher flow rates, only the enFlow can maintain this performance. This difference in device performance was more pronounced with cooled fluid. Nevertheless, the buddy lite is more convenient and, therefore, appropriate for use during patient transport or routine operations where there is no requirement for rapid fluid infusion. Acknowledgments We thank Dr. Gary Brook, Aachen, Germany for his proof reading.
Competing interests No external funding and no competing interests declared. Ancillary Article Information. 1 Reynolds BR, Forsythe RM, Harbrecht BG, et al.
Hypothermia in massive transfusion: have we been paying enough attention to it? Journal of Trauma and Acute Care Surgery 2012; 73: 486– 91.
2 Bernabei AF, Levison MA, Bender JS. The effects of hypothermia and injury severity on blood loss during trauma laparotomy. Journal of Trauma and Acute Care Surgery 1992; 33: 835– 9. 3 Bernardo LM, Gardner MJ, Lucke J, Ford H. The effects of core and peripheral warming methods on temperature and physiologic variables in injured children. Pediatric Emergency Care 2001; 17: 138– 42.
4 Shao L, Zheng H, Jia FJ, et al. Methods of patient warming during abdominal surgery.
PLoS One 2012; 7: e39622. 5 Bissonnette B, Paut O. Active warming of saline or blood is ineffective when standard infusion tubing is used: an experimental study.
Canadian Journal of Anesthesia 2002; 49: 270– 5. 6 Frank SM, Fleisher LA, Breslow MJ, et al.
Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial.
Journal of the American Medical Association 1997; 277: 1127– 34. 7 Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology 2005; 103: 25– 32.
8 Faries G, Johnston C, Pruitt KM, Plouff RT. Temperature relationship to distance and flow rate of warmed i.v.
Annals of Emergency Medicine 1991; 20: 1198– 200. 9 Department of Health Centre for Evidence-based Purchasing.
Market review. Intravenous fluid warming devices. CEP10014, 2010. Related content.
1 Hee Jung Kim, Sung Mook Yoo, Jae Ho Chung, Tae Sik Kim, Sung Ho Lee, Ho Sung Son, Evaluation of fluid warmer safety using hemorheologic analysis with outdated human blood, Clinical Hemorheology and Microcirculation, 2016, 62, 1, 13. 2 Hee Jung Kim, Sung Mook Yoo, Ho Sung Son, Chi Bum Ahn, Yeon Soo Shin, Jae Ho Chung, Kyung Sun, Evaluation of the Performance and Safety of a Newly Developed Intravenous Fluid Warmer, Artificial Organs, 2015, 39, 7, 591.
3 H. Son, The laboratory performance of the enFLOW®, buddy lite™and ThermoSens®fluid warmers, Anaesthesia, 2015, 70, 2, 205. 4 M. Harper, Peri-operative warming devices: performance and clinical application, Anaesthesia, 2014, 69, 6, 623.
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. IV Fluid / Blood Warming System Operator’s Manual Vital Signs a GE Healthcare Company. © 2012 General Electric Company – All rights reserved. All specifications subject to change without notice. GE, GE Monogram, and Vital Signs are trademarks of General Electric Company.
Enflow Blood Warmer Instruction Manual
enFlow is a trademark of General Electric Company Enginivity, LLC., a subsidiary of Vital Signs, Inc. Symbols Used on the Equipment The following symbols may be viewed on the any of the products or accessories that comprise the enFlow IV Fluid/Blood Warming System. Symbol Symbol Description Symbol Symbol Description Batch Code Catalog Number Serial Number Not made with natural rubber latex National Stock No. System Fault XX Low Battery Lock or Password required Unlock The CE Mark is the manufacturer’s or importer’s mark of Do not throw in trash conformity declaring compliance with all applicable directives (Safety, EMC, Machinery, Medical and others). Interek is accredited by OSHA as a NRTL, as well as by the Standards Council of Canada. CAUTIONS. 7 UNPACKING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM.9 TO BEGIN OPERATION OF THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM.
9 ENFLOW CONTROLLER (MODEL 120 SERIES) INDICATORS AND OPERATION. 11 ENFLOW WARMER (MODEL 100 SERIES) INDICATORS AND OPERATION. 13 CLEANING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS. IV Fluid/Blood Warming System Description The enFlow IV Fluid/Blood Warming System consists of the enFlow Warmer (Model 100 series), the enFlow Controller (Model 120 series), the enFlow Disposable Cartridge with or without IV Extension Set (Model 200 series).
Within seconds, this Warming System delivers normothermic infusate to the patient at flow rates of Keep Vein Open (KVO) to 200 mL/min when input fluid temperature is 20 °C. WARNINGS All IV fluid bags must be vented of air per IV fluid manufacturers’ directions prior to connecting to the infusion set. Standard IV line protocols for priming the complete infusion set, the enFlow Disposable Cartridge, and the extension set must be followed before connecting to a patient. Do not block the fan in the Controller as this may cause overheating. Although the Warmer has been tested to insure it will survive a drop of 1 m (3.28 ft.), care should be taken that the device is not dropped to reduce the potential of damage. Setting the clock to the local time is optional, but usually done on initial use. No changes in performance are affected by the clock’s setting.
D) Connect the enFlow IV Fluid/Blood Warmer cable to the Controller. This action is accomplished in three steps: 1. Turn right to lock. (See arrows on label.) e) The rear mounted I/0 (ON/OFF) switch on the Controller turns the power on and off. Switch the Controller to ON.
Upon startup, the Controller conducts a self-test. The power indicator illuminates green, the Controller display flashes “enFlow”, a short audible “Beep”. k) Do not wrap the Warmer in towels, sheets, blankets or drapes. Opening the Warmer covers immediately stops the heating but not the flow. M) To turn off the device, use the switch located at the rear of the controller.
EnFlow Controller (Model 120 series) Indicators and Operation Keypad Controller Display. Controller Display The Controller display continuously reflects the specific infusate temperature that the Warmer monitors and maintains.
Carefusion Enflow Fluid Warmer
The various readouts that may be depicted on the Controller display are described in the following tabulation: Table 1: Controller Display: Normal Operating Model Activity Display Reads Display Color and. enFlow Warmer (Model 100 series) Indicators and Operation The Warmer monitors and maintains the infusate temperature at 40 °C ± 2 °C. On the top of the Warmer, there are two status indicator lights (multicolored LEDs), which reflect the following: Power - indicates the power and operational status of the Warmer. Table 4: Indicator Status Status Warmer Disposable Power Temperature Audible Description Action Required Covers Cartridge Indicator Indicator Indicator Ready Open or None Flashing Unlit None Warmer unit has None Closed Green power, but is not every 3 heating seconds Power up Closed In place Red ½. Refer to Appendix C for the chart on “Warming System Response versus Fluid Temperature”. Refer to Warnings for additional information. Cleaning the enFlow IV Fluid/Blood Warming System Components Caution Do not clean with: ketones (MEK, acetone, etc.) or .
Controller. If fluid ingress is detected, set the Controller aside for an extended period of time to allow it to dry. Storing the enFlow IV Fluid/Blood Warming System Components The Warmer and Controller should be stored in a clean, dust free environment. (See Appendix A) 4400-0024 enFlow Operator’s Manual EN Rev.
IV Fluid/Blood Warming System Operational Checklist Warmer Serial No Controller Serial No Warming System Location/Identifier Date: Procedure Instructions Pass Input Output Fail Temp Temp Inspection Ensure that all cords and connectors are in good condition and void of any cuts, cracks, or frays. The systems use current Surface Mount Technology (SMT) and materials. If service is required, it must be performed by Vital Signs – a GE Healthcare Company or one of its authorized agents. Service by others voids the warranty and transfers the liability for malfunctions of the device to the servicer. Appendix A: Technical Specifications Warmer: 12.7 cm L x 6.6 cm W x 3.0 cm H, (5.0 in. Size W x 1.2 in. H) Controller: 23.6 cm L x 16.8 cm W x 9.7 cm H, (9.3 in.
Continuous Note Electromagnetic Compatibility (EMC) The enFlow IV Fluid / Blood Warmer System has been tested and found to comply with the limits for medical devices as set forth in IEC 60601-1-2: (2001) and related standards. These limits are designed to provide reasonable protection against electromagnetic interference (EMI) in a typical medical installation. Guidance and Manufacturer’s Declaration - Emissions The enFlow 100 with enFlow 120 is intended for use in the electromagnetic environment specified below. The customer or user of the enFlow 100 with enFlow 120 should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –. D=(3.5/3V/m)(Sqrt P) 80 to 800 MHz D=(7/3V/m)(Sqrt P) 800 MHz to 2.5 GHz where P is the max power in watts and D is the recommended separation distance in meters.
Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (3Vrms and 3V/m). Rain- Operational 1. Place an enFlow Power Supply /Controller in the rain chamber. Connect the enFlow IV Fluid Warmer and the extended power cable to the power supply.
Turn “on” the power supply. Expose to 1” of rain per minute in its left IV pole orientation for 10 minutes. Appendix B: Glossary enFlow IV Fluid/Blood The enFlow IV Fluid/Blood Warming System consists of three products: Warming System the Warmer (No. 980100), the Controller (No. 980121), and the Disposable Cartridge (No.
980200), which together form a system designed to warm intravenous fluids and blood products helping reduce hypothermic effects. Appendix C: Warming System Response by Temperature Fluid Heater Temperature LED on Display on Controller Audible Temp Warmer Alarm 30 °C Active Blue Flashing 30°C Blue Flashing 31 °C Active Blue Flashing 31°C Blue Flashing 32 °C Active Blue Flashing 32°C Blue Flashing 33 °C Active. Appendix D: Parts List 980105VS Warmer 980121EU Controller 980200EU Disposable cartridge 980202EU Disposable cartridge with IV extension set 980305VS Warmer Holder 980309VS Warmer Cord Clip 980307 enCheck Alarm testing Tool 44000024 Operator’s manual (USA) 44000060 Service manual (electronic version only, not available in print) 44000120 enCheck Users Guide English(EN) 91000178.
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