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

Page 19 of 26

 

 

 

Appendix A: Technical Specifications 

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 1.2 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:

 120 mm L x 10.6 mm W,  

(4.7 in. L x 0.4 in. W)

 

Weight

 

Warmer: 

(w/o Disposable)

:

 279 g, (9.8 oz.) 

Controller:

 1.8 kg, (3.9 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 to 200 mL/min 

Input Voltage 

Warmer:

 28 VDC at a maximum of 300 Watts 

Controller:

 110-120 or 220-240 VAC 

Temperature Set Point 

40 ºC

 

Over Temperature Set Point 

ASTM F-2172-02 

Alarms 

IEC60601-1-8:2006 

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 IP21 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 IP21 ≥ 12.5 diameter (See Page 23) 

Disposable Cartridge

 

and (optional IV Extension Set):

  IEC 

529 IP68 dust 

IV Extension Set):

  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) 

Relative Humidity, Operating and 
Storage 

Warmer: 

10 % to 90 % 

Controller: 

10 % to 90 %  

Disposable Cartridge

 

and (optional  

IV Extension Set):

  10 % to 90 % 

Содержание enFlow IV

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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