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

Page 18 of 26

 

 

 

Servicing the enFlow IV Fluid/Blood Warming System Components  

The enFlow IV Fluid/Blood Warming System components have been designed to be durable and long 
lasting.  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. If the unit stops working properly, contact Customer Service to obtain an RGA number 
prior to returning the unit to the enFlow Service Center. If damage has occurred to the heating 
surface, immediately remove it from service.  

 
RGA Number 

Prior to returning any Product, Original Purchaser must receive prior consent and must receive a 
Return Goods Authorization (RGA) number from Vital Signs, Inc. No Product may be returned without 
an RGA number. Our Customer Service Representatives can be reached by phone at 800-932-0760 
or by e-mail at 

[email protected]

.   

 
The Service Representative will troubleshoot your Product issue with you on the phone.  If it is 
necessary to return a Product under warranty, a replacement loaner will be shipped to you within 48 
hours.  (If the Product is no longer under warranty, the 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 prevent damage in transit, clearly 
marking the RGA number on the outside of the box.  The return address will be provided to you. 
 
Note

  Federal (U.S.A.) Law requires contaminated Medical Equipment to be cleaned and disinfected 

before shipment.  If this is not done, your unit will be immediately returned as it is received. 
 

Warmer (Model 100 series) 

The Warmer is permanently sealed against fluid ingress and has no user serviceable parts inside. 
 

Caution

 

Normal wear and tear during use of the Warmer may cause the device to be susceptible to fluid 
ingress. Carefully inspect the heating surface of the Warmer for tears or foreign matter before 
each use and take out of service if necessary. 
  
Due to highly stable components, microprocessor control, and built-in self-tests, an annual 
performance check is sufficient.  
 
The steps listed in the enFlow IV Fluid/Blood Warming System Operational checklist should be 
performed at least once a year, or as required by your accrediting body. 
 

Controller (Model 120 series) 

The Controller (Product No. 980121) contains no user serviceable parts inside.  Check the fuses 
located in the power entry module if the Controller fails to function.  The AC line power cord must be 
removed to do this.    
 
The Controller should be subjected to routine safety checks as required by local regulations, (i.e. 
Earthing Impedance, Leakage Current). 

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...

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