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4400-0024-EN Rev A

1. Turn Controller over.

Diagram 1

Diagram 2

Controller Model 121

LOCK

UNLOC

K

Controller Model 121

LO

CK

UN

LO

CK

2. To remove the bottom, unscrew pole clamp screw; unscrew six (6) screws shown below. Next, lift the cover.

Diagram 3

Diagram 4

Screw_1

Screw_5

Screw_6

Screw_3

Screw_4

Screw_2

Pole Clamp Screw

3. Remove power supply assembly

a. On the power supply assembly, unscrew two (2) screws shown below (see Diagram 5). Also remove the screws holding the zip ties to the post for the

ferrite bead securement.

b. Gently lift assembly by holding pole clamp, and prop up with a small block or box (see Diagram 6).

Diagram 5

Diagram 6

Screw_1

Pole Clamp

Zip ties

Screw_2

Display

Board

Battery

Post_1

Post_2

Fan Assembly

Display Board

Block

White Posts

Pole Clamp

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Summary of Contents for enFlow IV

Page 1: ...enFlow IV fluid and blood warmer System manual ...

Page 2: ... If you have questions or concerns regarding this manual or product please contact Customer Service or Technical Support for assistance Customer Service E mail gmb medspec custservice carefusion com Phone 1 800 323 9088 option 1 Technical Support Phone 1 973 956 5431 Manufactured for Vital Signs Inc a GE Healthcare Company 20 Campus Road Totowa New Jersey 07512 USA EC RE P GE Medical Systems SCS 2...

Page 3: ...X Not made with natural rubber late x Not Made With Natural Rubber Latex NS N National Stock No US Military Expiration Date 2 Single Use Only Do Not Re Use Direct Current STERILE R Sterilized Using Irradiation Alternating Current Keep Dry Type BF Applied Part Defibrillation Proof STERILIZ E 2 Do Not Re Sterilize Do Not Use if Package is Damaged Caution Fuse Temperature Thermometer NON PYROGENIC No...

Page 4: ...sure dust tight continuous water immersion Rx ON LY Caution U S Federal law restricts this device to sale by or on the order of a physician Surface may be hot Consult Instructions for Use Do not encase the Warmer with any external coverings like towels sheets blankets or drapes Covering the Warmer restricts the natural convection of heat xx System Fault XX Low Battery Lock or Password Required Unl...

Page 5: ...5 Servicing the enFlow IV fluid blood warming system components 16 Instructions for replacing the Controller clock battery 16 Instructions for changing the Controller fuse 18 enFlow fluid warming system temperature controls and alarms 19 Temperature control 19 Audible Visual alarm 19 enFlow troubleshooting 19 Electromagnetic interference 19 Interference confirmation 19 Interference reduction steps...

Page 6: ...g 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 s...

Page 7: ... built in self tests an annual performance check is sufficient The steps listed in the enFlow IV fluid blood warming system operational checklist Appendix F should be performed at least once a year or as required by your accrediting body The enCheck is to be used only with the enFlow Warmer and Controller Do not touch the enCheck contact plate surface during or immediately after use since it may b...

Page 8: ...he 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 as well as a keypad which controls the clock and the mute feature The Controller display is always shown right side up Controller Model 121 40 C 2 20 P LOCK UNLOCK POWER Each Disposable Cartridge and the ...

Page 9: ...l 100 Warmer Warmer Cord Clip IV Line Clip USB Manual Patient Leakage Report Certificate of Conformance Model 121 Controller Patient Leakage Report Warmer Mount Warmer Mount Instructions USB Manual Model 200 Disposable Cartridge IFU Model 202 Disposable Cartridge with IV extension set IFU To begin operation of the enFlow IV fluid blood warming system a Place the Controller on a firm level surface ...

Page 10: ...re keyed in both orientation and configuration This feature ensures that the Warmer can only be plugged in properly Additionally it prevents other plug devices from fitting into this receptacle 3 Turn right to lock See arrows on label e The rear mounted I 0 ON OFF switch on the Controller turns the power on and off Switch the Controller to ON Upon startup the Controller conducts a self test The po...

Page 11: ...Disposable Cartridge Adjust the fluid flow to the desired rate PO W ER TE M P O FF O N i Place the IV line in the IV Line Clip in order to prevent it from kinking O N IV Line Clip j The Warmer is designed to be placed on the bed and or attached to patient coverings in close proximity to the site of infusion using the cord clip P N 980309VS 20 Cushion the patient from the Warmer to aid in the preve...

Page 12: ...the right or left arrow key to access the padlock symbol to enter the password screen b The password is 781 c An underscore will display under the first digit field Press the arrow key to set the appropriate digit d Next press the center key again to toggle to the next place e Repeat steps three and four for the second and third digits If an incorrect password is entered the system reverts to the ...

Page 13: ...mperature LED Fault detected System Fault XX If a system fault message is on the Controller display refer to the system fault section Appendix B or contact Technical Support Red High priority alarm Table 3 Controller Display Setup Mode Activity Display reads Display color and function While powering up the Controller hold the center button down until the clock screen is displayed Then use the butt...

Page 14: ...Solid Green None Infusate temperature is 35 C and 42 C None In operation Closed In place Solid Green Solid Yellow None Infusate and or ambient temperature is 42 C but less than an Over Temp condition Observe This state whereby the infusate is 42 ºC should only be entered periodically during changes in flow rate or infusate temperature In operation Closed In place Flashing Red N A Varies Continuous...

Page 15: ...completely before disinfecting so that the disinfecting solution will not be diluted Disinfecting 1 The enFlow Warmer may be disinfected using commercially available solutions with no greater than 2 4 glutaraldehyde and by following the solution manufacturer s recommendations Refer to list in Cleaning Section above 2 Soak the Warmer in the disinfectant solution according to the manufacturer s appl...

Page 16: ...y Representative will discuss replacement options You will be issued a RGA number You will be instructed to return the product in sufficient packaging to prevent damage in transit clearly marking the RGA number on the outside of the box The return address will be provided to you Warmer Model 100 series The Warmer is permanently sealed against fluid ingress and has no user serviceable parts inside ...

Page 17: ...ew_6 Screw_3 Screw_4 Screw_2 Pole Clamp Screw 3 Remove power supply assembly a On the power supply assembly unscrew two 2 screws shown below see Diagram 5 Also remove the screws holding the zip ties to the post for the ferrite bead securement b Gently lift assembly by holding pole clamp and prop up with a small block or box see Diagram 6 Diagram 5 Diagram 6 Screw_1 Pole Clamp Zip ties Screw_2 Disp...

Page 18: ...d 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 corner post_2 e Reinsert and tighten the two 2 screws for the power assembly see Diagram 5 f Reinstall the two screws for the zip ties that were taken apart in step 3a g Attach bottom cover reinsert and tighten the six 6 related cover screws see Diagram 3 h Reins...

Page 19: ...Maintenance Procedure enFlow troubleshooting Electromagnetic interference ECG EEG or EMG cardiac or neuro monitoring artifact or other interference caused by the enFlow is an uncommon event Cardiac or neuro monitoring interference is common and well documented in medical literature There are published suggestions to reduce or eliminate the interference that should be employed Interference of the m...

Page 20: ...justing it to Monitoring Check the ECG pads impedance Contact your current supplier of monitoring pads or your local Vital Signs 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 enCheck Model 400 user guide Intended use Us...

Page 21: ...g Temperature Range 5 C to 40 C Input Voltage 12 30 V 0 5A Storage Temperature Range 30 C to 70 C Maximum of 14 W Relative Humidity Range 10 to 90 Cleaning the enCheck 1 Use only approved cleaning solutions Please reference Cleaning the enFlow IV fluid blood warming system components for a list of approved cleaning solutions 2 Moisten a clean cloth with the cleaning solution do not spray or pour c...

Page 22: ...xtension set IEC 529 IP68 continuous immersion Penetration Warmer IEC 529 IP67 dust tight Controller IEC 529 IP31 2 5 mm diameter Disposable Cartridge and optional IV extension set IEC 529 IP68 dust IV extension set IEC 529 IP68 dust tight Electrical Safety CAN CSA C22 2 No 60601 1 2008 Ed 03 AAMI ES60601 1 2005 IEC 60601 1 2005 Ed 03 IEC 60601 1 6 2010 Ed 3 and IEC 60601 1 8 2006 Ed 2 Relative Hu...

Page 23: ...t 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 hospi...

Page 24: ... strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels 3Vrms and 3V m Interference may occur in the vicinity of equipment containing a transmitter Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the enFlow The enFlow 100 with enFlow 121 is intended for use in the electromagnetic envir...

Page 25: ...tion 41 Covers failure This fault occurs every time the covers are opened while heating 50 Heater MOSFET failure or Circuit Breaker Trip This fault code is indicative of a Heater Over temperature protection fault 52 Clock oscillator failure This fault is activated if the external crystal oscillator fails 53 Internal temperature C failure This failure is indicative of the Warmer being too hot insid...

Page 26: ...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 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 seco...

Page 27: ...SA 44000113 Instructions For Use Bulgarian BG 91000170 Power Cord Continental Europe 44000114 Instructions For Use Croatian HR 91000172 Power Cord Great Britain 44000115 Instructions For Use Czech CS 91000173 Power Cord Italy 44000116 Instructions For Use Greek EL 91000174 Power Cord Israel 44000117 Instructions For Use Polish PL 91000171 Power Cord Switzerland 44000118 Instructions For Use Russia...

Page 28: ...thout a Disposable Cartridge inside to the Controller Confirm the beep signaling connection Confirm the display continues to show the conditional message not heating Confirm the Warmer power LED is flashing green Electrical safety 1 Ground wire resistance Equipment enFlow Controller Safety analyzer with test lead Purpose The purpose of this test is to check the resistance in ohms of the ground pin...

Page 29: ...S power to ON 4 Record the polarity and ground readings for the Controller for both power on and off scenarios for the following configurations Allowable values of continuous LEAKAGE CURRENTS in μA ENCLOSURE LEAKAGE CURRENT TYPE BF Normal polarity normal ground Normal Condition 100 Reverse polarity normal ground Single Fault Condition 500 Reverse polarity open ground Double Fault Condition 500 Nor...

Page 30: ...tension set tubing with saline Note It doesn t matter which way the wire is inserted into the tubing just be certain that the wire is in contact with the fluid 5 Next put a non venting cap on the open end of the extension set 6 Place the Disposable Cartridge setup in the Warmer 7 Connect the ECG lead from the leakage tester to the wire inserted into the extension set tubing 8 Perform the ECG lead ...

Page 31: ... 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 into a hospital grade outlet 2 Connect the enCheck to the Controller by inserting the male plug end of the enCheck Hubbell connector into the female receptacle on the front face of the Controller Push it in so that the plug cove...

Page 32: ...f the Controller to the ON position Wait for the thermometer to stabilize 30 to 60 sec assuming all equipment is close to 20 C 8 The temperature on the thermometer should be 40 C 2 C Note If the temperature in step 8 above is not 40 C 2 C take the Warmer unit out of service Call Customer Service for an RGA Please reference the RGA section in Servicing the enFlow IV fluid blood warming system compo...

Page 33: ...aduated cylinder 100 to 500 mL Purpose This test is performed to ascertain that the output fluid temperature of the enFlow system while using a 22 9 cm 9 in extension set is 40 C 2 0 C when the input fluid is 20 C through the flow rates of 25 100 mL min Standard Flows Additionally it is run to determine that the rise in fluid temperature is 16 5 C when the input fluid is 20 C utilizing flow rates ...

Page 34: ... temperature and the temperature probes to stabilize 8 Record the input fluid temperature The acceptable temperature range is 20 C 2 0 C 9 Record the output fluid temperature The acceptable temperature range is 40 C 2 0 C 10 It is recommended to repeat steps 1 9 for the flow rate of 60 mL a minute Measure input and output temperatures of fluid high flows 11 Repeat steps 1 7 for the high flow rates...

Page 35: ... probe connector to the Calibrated Thermometer 14 Verify the LED and display indicators are red Monitor the temperature on the Calibrated Temperature meter and on the enFlow Controller display the temperature will gradually drop and as it falls below 45 C the Controller display and the Warmer LED should change state from Red to Yellow Verify that the Warmer LED and the Controller display indicator...

Page 36: ... 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...

Page 37: ...l NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail Pass Fail Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail Pass Fail Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail Pass Fail Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail NA Pass Fail Pass Fail Pass Fail NA Pas...

Page 38: ...rature 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 C Over Temperature Alarm Check Use performance testing setup Change the source of fluid s temperature to 50 C 2 C Turn the enFlow system on and establish a fluid flow of 100 20 mL min Wait for the temperature at the probes to stabilize R...

Page 39: ...Thermometer to K type setting Insert the enCheck unit into the Warmer so the bottom end of the unit is keyed similarly as the Warmer Cartridge so that it only fits in the correct orientation curved section on the left side and close the Warmer covers Switch the Main power switch on the back of enFlow Controller to the ON or l position Verify that the Orange power LED indicator is illuminated on th...

Page 40: ...k and the mute feature Additionally it converts AC line power to 28 5 Volts DC and is used as a power source for the Warmer Disposable Cartridge Model 200 The sterile single patient use Disposable Cartridge is used as an in line component of an IV infusion set to heat fluids blood being administered to the patient s body Disposable Cartridge with IV extension set Model 202 The Disposable Cartridge...

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