background image

4400-0024 enFlow Operator’s Manual EN Rev. T 05/12     

Page 7 of 26

 

 

 

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.  Care must be taken to ensure there is not sufficient air in 
the fluid bag and lines to cause an air embolism. 

 

The 'High Priority Alarm' is a flashing RED LED, a flashing RED Controller display, and an 
audible alarm, indicating that the infusate is over temperature.  Stop the fluid flow, and 
slide the Warmer covers open to stop warming. If the above occurs, then replace the 
Warmer and contact Technical Support.  The attending practitioner should remain within 
4m of the patient when the device is in use to enable visualisation of the enFlow display 
and hear the audible high priority alarm. 

 

The Warmer contains magnets; do not operate within 15 cm (6 in.) of a pacemaker or 
other devices that may be sensitive to strong magnetic fields. 

 

The Disposable Cartridge may be a potential biohazard during or after use.  Handle and 
dispose of in accordance with acceptable medical practice and applicable regulations. 

 

Do not use in the presence of flammable anesthetics. 

 

Replace the fuses with only Bussmann

®

 part # GDB 5A or equivalent. Bussmann

® 

is 

registered in the United States or abroad by Cooper Industries, Inc. or its subsidiaries. 

 

The Disposable Cartridge should not be used for greater than 24 hours. 

 

Ensure that the Disposable Cartridge expiration date has not passed. 

 

If the IV line runs dry, disconnect the Disposable Cartridge from the Warmer. Re-prime 
the entire IV system using aseptic techniques. Ensure all the air is removed from both the 
line and the Disposable Cartridge. Replace the Disposable Cartridge in the Warmer. 

 

The enFlow Warmer is to be

 

used only with approved enFlow power sources and the 

enFlow Disposable Cartridge. 

 

To avoid risk of electric shock, this equipment must only be connected to a supply main 
that is grounded.  Should the need arise the device may be disconnected by the appliance 
coupler. 

Cautions 

 

Follow the AABB "Guidelines for the Use of Blood Warming Devices" (© 2006) which caution 
against warming when administering platelets, cryoprecipitate, or granulocyte suspensions. 

 

Some drugs or drug preparations may be sensitive to warming.  As with any fluid or blood 
warming system, carefully review the drug manufacturer's literature for information about 
thermal sensitivity. 

 

The disposable cartridge contains aluminum. Review the preparation or solution 
manufacturer's instructions for use about chemical sensitivity. 

 

Do not affix, place or bind the Warmer directly to a patient during general use. 

 

Do not wrap the Warmer in towels, sheets, blankets or drapes. 

 

If the enFlow system is used for pre hospital transport or transfer to another facility  

o

 

place an insulating and cushioning fabric layer, such as soft cotton towels or gauze, at 
least .25” or 6 mm thick in between the underside of the Warmer and the patient.  Do not 
use foam or gel pads. Cushioning the patient from the Warmer will help prevent 
perioperative peripheral neuropathies. 

 

The Warmer heating surface and Disposable Cartridge can get quite warm when heating 
cold IV fluids/blood at high flow rates. Wait a few seconds after stopping the IV fluid/blood 
flow before removing the Disposable Cartridge. 

 

The Controller should only be plugged into a hospital grade outlet. 

Summary of Contents for enFlow IV

Page 1: ...enFlow IV Fluid Blood Warming System Operator s Manual Vital Signs a GE Healthcare Company...

Page 2: ...ements If you have questions or concerns regarding this manual or product please contact one of the following for assistance Customer Service E mail vitalsignscustomerservice ge com Phone 1 800 932 07...

Page 3: ...ds a reference point Close Di 2 ethylhexyl phthalate Free In transport applications it is advised to cushion and insulate the Warmer from the patient s skin and apply the Warmer as loosely as acceptab...

Page 4: ...eclaring 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 This mark indicates tha...

Page 5: ...STEM 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 15 STORING...

Page 6: ...ood The Controller serves as a power supply for the Warmer unit The Controller is designed to mount on an IV pole or sit on a table top The front panel includes a Controller reading in degrees Celsius...

Page 7: ...the Disposable Cartridge from the Warmer Re prime the entire IV system using aseptic techniques Ensure all the air is removed from both the line and the Disposable Cartridge Replace the Disposable Ca...

Page 8: ...hould have a base diameter of no less than 61 cm 24 in A Controller mounted too high on the IV pole may cause instability IV pole accessories or the attachment of fluid bags may also cause instability...

Page 9: ...nFlow IV Fluid Blood Warming System a Place the Controller on a firm level surface or on an IV pole with an outside dimension of no greater than 3 0 cm 1 25 in Two Controllers may also be mounted next...

Page 10: ...ion set to the patient and place the Disposable Cartridge into the Warmer h Completely close the covers on the Warmer by sliding them inward toward each other until the covers meet Upon closing the co...

Page 11: ...s blankets or drapes l 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 12...

Page 12: ...to Warmer Temp LED Fault detected System Fault XX If a system fault message is on the Controller display contact Technical Support Red High Priority Alarm Table 3 Controller Display Setup Mode Activi...

Page 13: ...n 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 Temperature indicates that th...

Page 14: ...ational range Infusate temperature is 20 C and or the flow rate is 200 mL min Reduce the flow rate if possible If there is no change in operational temperature consider replacing the Warmer and contac...

Page 15: ...taraldehyde based cleaners Chlorhexidine Cleaning the Warmer Wipe down and or wash 1 After each use clean the Warmer only as required In many instances it may only need to be wiped clean 2 If the warm...

Page 16: ...nly approved cleaning solutions 2 Moisten a clean cloth with the cleaning solution do not spray or pour cleaning solutions directly on to the Controller 3 Wipe the surface of the Controller taking car...

Page 17: ...ow of 100 20 mL min Wait for the temperature probes to stabilize Record the input fluid temperature Input fluid temperature 20 C 2 C Record the output fluid temperature Output fluid temperature 40 C 2...

Page 18: ...Service Representative will discuss repair replacement options You will be issued a Return Goods Authorization RGA number You will be instructed to return the Product in packaging sufficient to preven...

Page 19: ...a maximum of 300 Watts Controller 110 120 or 220 240 VAC Temperature Set Point 40 C Over Temperature Set Point ASTM F 2172 02 Alarms IEC60601 1 8 2006 Input Current 5 A Input Frequency Range Warmer D...

Page 20: ...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...

Page 21: ...kV I Os 2kV Mains 1kV I Os Mains power quality should be that of a typical commercial or hospital environment Surge EN IEC 61000 4 5 1kV Differential 2kV Common 1kV Differential 2kV Common Mains power...

Page 22: ...t and the enFlow The enFlow 100 with enFlow 120 is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the enFlow 100 with enFlow...

Page 23: ...e rain chamber 9 Unplug the power supply and wipe excess water away from the outside 10 Perform validation test to confirm proper operation Record serial numbers of test items TPTR_083 11 Using a scre...

Page 24: ...in degrees C as well as containing a keypad which controls the clock and the mute feature Additionally it converts AC line power to 28 Volts DC and is used as a power source for the Warmer Disposable...

Page 25: ...reen 42 C Green No 43 C Off Yellow 43 C Yellow No 44 C Off Yellow 44 C Yellow No 45 C Off Red Flashing High Priority Alarm after 20 seconds 45 C after 20 seconds Red Flashing Over Temp message After 2...

Page 26: ...00EU 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...

Reviews: