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

Page 21 of 26

 

 

 

 

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 – Guidance 

RF Emissions 
Radiated 
CISPR 11 

Group 1, Class B  The enFlow 100 with enFlow 120 uses RF energy only for its internal 

function. Therefore, its RF emissions are very low and are not likely to 
cause any interference in nearby electronic equipment. 

Harmonics 
IEC 61000-3-2 

Class A 

The enFlow 100 with enFlow 120 is suitable for use in all establishments, 
other than domestic, and those directly connected to the public low 
voltage power supply network that supplies buildings used for domestic 
purposes. 

Flicker IEC 61000-3-3 

Complies 

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 

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. 

Immunity Test 

EN/ IEC 60601  

Test Level 

Compliance Level 

Electromagnetic Environment – Guidance 

ESD 
EN/IEC 61000-4-2 

Level 3 (±6kV) 
Contact 
 
Level 3 (±8kV) 
Air 

Level 3 (±6kV) 
Contact 
 
Level 3 (±8kV) 
Air 

Floors should be wood, concrete or 
ceramic tile. If floors are synthetic, the 
r/h should be at least 30% 

EFT 
EN/IEC 61000-4-4 

 ±2kV Mains 
±1kV 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 quality should be that of a 
typical commercial or hospital environment. 

Voltage 
Dips/Dropout 
EN/IEC 61000-4-11 

>95% Dip for 
0.5 Cycle 
 
60% Dip for 
5 Cycles 
 
30% Dip for 
25 Cycles 
 
>95% Dip for 
5 Seconds 

100% Dip for 
0.5 Cycle 
 
60% Dip for 
5 Cycles 
 
30% Dip for 
25 Cycles 
 
See Note 1 

Mains power quality should be that of a 
typical commercial or hospital 
environment. If the user of the enFlow 
100 with enFlow 120 requires 
continued operation during power mains 
interruptions, it is recommended that 
the enFlow 100 with enFlow 120 be 
powered from an uninterruptible 
power supply or battery. 

Power Frequency 
50/60Hz 
Magnetic Field 
EN/IEC 61000-4-8 

3 A/m 

3 A/m 

Power frequency magnetic fields 
should be that of a typical commercial 
or hospital environment. 

Note 1) During the 5 Second event, the enFlow 100 and 120 power off, but return to normal operation as soon as 
power is restored. 

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.

 

Immunity Test  EN/IEC 60601 

Test Level 

Compliance 
Level 

Electromagnetic Environment – Guidance 

 
Conducted RF 
EN/IEC 61000-
4-6 
 
Radiated RF 
EN/IEC 61000-

 
3 Vrms 
150 kHz to 80 MHz 
 
3 V/m 
80 MHz to 2.5 GHz 
 

 
3 Vrms 
 
 
 
 
3 V/m 

Portable and mobile communications 
equipment should be separated from 
the enFlow 100 with enFlow 120 by no 
less than the distances calculated/listed 
below: 
 
D=(3.5/3V/m)(Sqrt P) 

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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