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4400_0060

enFlow Service Manual Rev. F 04/12

Page 19 of 36

Vibration

MIL-STD-810F

Radiated Magnetic Field Emissions

MIL-STD 461D, RE101 (7 cm test limit 30 Hz-100Khz); EMC
IEC 60601-1-2:2007

Safety Classifications

Type of protection against electrical
shock

Class I, or Internally Powered

Degree of protection against electric
shock

Type BF, Defibrillation-Proof

Mode of operation

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.  The
enFlow System generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause interference to other devices in the vicinity.  However, there is
no guarantee that interference will not occur in a particular installation.  If the enFlow System does cause
interference to other devices, which can be determined by turning the Controller/AC Power Pack off and on,
the user is encouraged to try to correct the interference by one or more of the following measures:

-

Reposition the Warmer and any intertwined cables.

-

Check ECG monitoring electrode contact and impedance.

-

Confirm monitoring lead wires are functioning properly and shielding is intact.

-

Connect the Controller/AC Power Pack into an outlet on a circuit different from that to which the
other device(s) are connected.

-

Consult the manufacturer for help.

Safety Classifications

Type of protection against electrical shock ......................... Class I, or Internally Powered
Degree of protection against electric shock ...................... Type BF, Defibrillation-Proof
Mode of operation ............................................................................ Continuous

Clock Battery Specifications

Cell #....................................................... CR2032
Classification…………………………………. Lithium Coin
Chemical System…………………………… Lithium / Manganese Dioxide (Li/MnO2)
Designation……………………………………..  ANSI / NEDA-5004LC, IEC-CR2032
Nominal Voltage…………………………….  3.0 Volts
Typical Capacity…………………………….. 220 mAh

enErgy Battery Specifications

Voltage……………………………………………….. 28VDC
Capacity……………………………………………… 3 A hrs.
Chemistry……………………………………………. Li-ion

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Содержание Vital Signs enFlow

Страница 1: ...enFlow IV Fluid Blood Warming System Service Manual ...

Страница 2: ...esult in injury to the service provider operator or patient from electric shock mechanical or other hazards If you have questions or concerns regarding these manuals or product please contact one of the following for assistance Customer Service Phone 800 932 0760m option 1 Email vitalsignscustomerservice ge com Technical Support Phone 1 973 956 5431 Service Center Address Vital Signs Inc a GE Heal...

Страница 3: ... 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 acceptable checking regularly for signs of potential pressure related injury Manufacturer IP67 Degree of protection provided by enclosure dust tight temporary water immersion IP21 Degree of protection provided ...

Страница 4: ...hinery Medical and others Not Heating Heating Normal Operation Alarm Muted for an intermittent time period Press Any Key to Mute Alarm System Fault XX Authorized Representative in the European Community Interek is accredited by OSHA as a NRTL as well as by the Standards Council of Canada This mark indicates that the product has been tested to CAN CSA C22 2 No 60601 1 2008 Ed 03 AAMI ES60601 1 2005...

Страница 5: ...ING THE ENFLOW IV FLUID BLOOD WARMING SYSTEM COMPONENTS 11 WARMER MODEL 100 SERIES 11 CONTROLLER AC POWER PACK MODEL 120 SERIES SETUP INSTRUCTIONS 12 CONTROLLER AC POWER PACK MODEL 120 SERIES AND AC POWER PACK MODEL 120 SERIES 12 ENFLOW FLUID WARMING SYSTEM TEMPERATURE CONTROL AND ALARMS 15 ENFLOW TROUBLESHOOTING 16 APPENDIX A TECHNICAL SPECIFICATIONS 18 APPENDIX B WARMER FAULT CODE TABLE 24 APPEN...

Страница 6: ...edundant temperature sensors to help ensure fluid temperature accuracy and reliability It also includes two independent over heating protectors Continuous internal diagnostics monitor essential components and system parameters when heating fluid blood The only distinction between the two versions of the Warmer both of which are Model 100 series is the connector at the end of the power cord which d...

Страница 7: ... Warmer and the Controller AC Power Pack combine to complete the enFlow IV Fluid Blood Warming System Indication for Use The enFlow IV Fluid Blood Warming System s intended use is for warming blood blood products and intravenous solutions prior to administration It is designed to be used by healthcare professionals in hospital clinical and field environments to help prevent hypothermia Clinical an...

Страница 8: ...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 ...

Страница 9: ...less than 61 cm 24 in A Controller AC Power Pack mounted too high on the IV pole may cause instability IV pole accessories or the attachment of fluid bags may also cause instability 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 serv...

Страница 10: ... brush to gently scrub the Warmer to remove any foreign material 3 Rinse thoroughly with distilled water Do not immerse the Warmer s electrical plug connector Drying 1 After cleaning dry completely before placing back into use If disinfecting is required dry completely before disinfecting so that the disinfecting solution will not be diluted Disinfecting 1 The enFlow Warmer may be disinfected usin...

Страница 11: ...inal 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 1 973 956 5431 or by e mail at vitalsignscustomerservice ge com The Technical Support Representative will troubleshoot your Product issue with you on the phone If it i...

Страница 12: ...center key again to toggle to the next place d Repeat steps three and four for the second and third digits If an incorrect password is entered the system reverts to the set zone screen e After the third digit is set press the center key again First a green padlock and then the zone USA will appear Press the right arrow to change to INTL f Press the center key again to set The system begins to oper...

Страница 13: ...Pack over 2 To remove the bottom unscrew Pole Clamp screw unscrew 4 screws shown below Next lift the cover 3 Power Assembly a On the power supply assembly unscrew 2 screws shown below see Diagram 5 b Gently lift up assembly by holding pole clamp and prop up with a small block or box see Diagram 6 Diagram 1 Diagram 2 Diagram 4 Diagram 5 Diagram 6 Diagram 3 ...

Страница 14: ...display board see Diagram 5 b When reseating display board make sure that all wires are between the two white posts see Diagram 6 c When reseating the fan assembly on the display board end make sure that the wires are inside the corner post_1 see Diagram 5 and wrap around the edge of the fan assembly d On the opposite end from the display board make sure the wires go around the outside of the corn...

Страница 15: ...uid temperature for an over temperature condition and system faults The alarm function is tested each time a Cartridge is inserted The audible alarm is briefly sounded and the red light emitting diode indicator is also briefly illuminated If a dangerous condition occurs a continuous audible and visual alarm is activated When used with the Model 121 Controller the audible alarm will come from the C...

Страница 16: ...up peeled back or otherwise exposing the conductive gel layer Confirm that the leadwires connectors are properly and fully attached Consider reapplying monitoring electrodes if there is any suspicion they have become dried out Confirm the patient is properly grounded In many cases and in all cases using mono polar or bi phase cautery a grounding pad should present and applied according to the manu...

Страница 17: ...et on Diagnostic consider adjusting it to Monitoring Check the ECG pads impedance Contact your current supplier of monitoring pads or your local GE Healthcare representative to determine if a lower impedance version is available High impedance monitoring pads are less sensitive to the very low signal strength from the heart beat and appear to be more prone to pronounced interference ...

Страница 18: ...oint 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 IPX7 30 minutes immersion at a depth of 91 4 cm 36 in Controller IEC 529 IPX1 dripping water Disposable Cartridge and...

Страница 19: ...no guarantee that interference will not occur in a particular installation If the enFlow System does cause interference to other devices which can be determined by turning the Controller AC Power Pack off and on the user is encouraged to try to correct the interference by one or more of the following measures Reposition the Warmer and any intertwined cables Check ECG monitoring electrode contact a...

Страница 20: ...V 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 D...

Страница 21: ...romagnetic 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...

Страница 22: ...enFlow 100 with enFlow 120 by no less than the distances calculated listed below D 3 5 3V m Sqrt P 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 ...

Страница 23: ...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 screwdriver open the power supply Note any moisture inside the power supply or use a camera to record its location inside the supply Notes The EDUT was placed in the Singleton Model 22 Rain Chamber Opened u...

Страница 24: ...s done on the memory at power up 32 Flash Memory Test Failure A check sum is done on the memory at power up 40 OT Fuse or Low Battery Failure This is a dual function failure First if the Warmer is powered either by the battery or the Controller AC Power Pack and the output voltage is too low this fault code will be activated It is accompanied by a YELLOW power light on the Warmer Second if this fa...

Страница 25: ...s a temperature readout 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 Cartridge Model 200 series The Disposable Cartridge uses a sterile single use component to be used as an in line component of an IV infusion set for the heating of the fluids b...

Страница 26: ... 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 20 seconds 46 C Off Red Flashing High Priority Alarm after 16 seconds 46 C after 16 seconds Red Flashing Over Temp message After 16 seconds 47 C Off Red Flashing High Priority Alarm after 12 seconds 47 C after 12 seconds Red Flashing Over Temp message A...

Страница 27: ... Use Dutch NL 44000080 Instructions For Use Norwegian NO 44000081 Instructions For Use Swedish SE 44000084 Instructions For Use Turkish TR 44000092 Instructions For Use English UK 44000083 Instructions For Use Chinese CN 44000085 Instructions For Use Portuguese PR 44000108 Preventive Maintenance Record English EN 44000113 Instructions For Use Bulgarian BG 44000114 Instructions For Use Croatian HR ...

Страница 28: ...ible Temperature Readout Display and Status Indicator Lights 1 Plug the Controller AC Power Pack into a functioning power supply Set the MAINS power to ON Confirm the Controller AC Power Pack power indicator is illuminated and displaying a green color Confirm the display panel Controller AC Power Pack only shows in yellow the conditional message not heating 2 Connect the Warmer without a Disposabl...

Страница 29: ...edure 1 Plug the power cord of the Controller AC Power Pack into the safety analyzer 2 Turn the knob on the safety analyzer to the chassis leakage function 3 Power the safety analyzer by plugging in and setting the MAINS power to ON 4 Record the polarity and ground readings for the Controller AC Power Pack for both power on and off scenarios for the following configurations Allowable values of con...

Страница 30: ...g When the enCheck is connected and running in the normal mode the heat is generated from the warmer unit using the same technology as when a cartridge is installed This mode allows for confirmation of the temperature output of the Warmer 1 Plug the Controller AC Power Pack into a hospital grade outlet 2 Connect the enCheck to the Controller AC Power Pack by inserting the male plug end of the enCh...

Страница 31: ...on 5 After reaching temperatures of 45 C the Warmer LED will blink red temperatures shown on the Controller display will be in Red and the audible alarm will sound 6 Move the MAINS power switch on the back of the Controller AC Power Pack to the OFF position 7 Open the Warmer covers and carefully remove the enCheck Use caution as the surface of the contact plate on the underside of the enCheck may ...

Страница 32: ...r to confirm that the output end of the extension set empties into the waste water container 7 Power on the enFlow system and establish a fluid flow of 100 20 mL min Then allow at least 20 seconds for the power on self test to complete the temperature display to read a stable temperature and for the temperature probes to stabilize 8 Record the input fluid temperature The acceptable temperature ran...

Страница 33: ... test to complete and the temperature display to ready a stable temperature Confirm all LEDS are illuminated green 6 Release the clamp and establish a fluid flow of 100 20 mL min 7 With the thermometer confirm the temperature of the fluid at both the input and output end of cartridge 8 The Over Temperature alarm sounds within approximately 20 seconds or less of the output fluid temperature reachin...

Страница 34: ...4400_0060 enFlow Service Manual Rev F 04 12 Page 34 of 36 Blank page ...

Страница 35: ...ctrical Safety Check Ground Wire Resistance circle Estimated Leakage Current at the AC Power Cord circle Estimate Leakage Current of the Warmer to the saline in the IV Line circle enCheck Performance circle enCheck Over Temp circle enCheck Alternate Alarm Text circle Initial and Date Pass Fail Pass Fail Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA ...

Страница 36: ...4400_0060 enFlow Service Manual Rev F 04 12 Page 36 of 36 ...

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