Medi-Temp III REF FW600 Series Blood/Fluid Warmer Operator s
Contents
1. ENGLISH Description Catalog Application Priming Number Volume Standard D25340CE KVO 1I50 ml min 39 ml Standard with 48 extension D25310CE KVO 150 ml min 48 ml Standard with 60 extension D25315CE KVO 150 ml min 50 ml Pediatric with 30 extension D25320CE KVO 100 ml min 30 ml High Flow with 48 extension D25330CE 100 500 ml min 79 ml KVO minimum flow required to keep veins open Figure 2 D25000 series warming sets A Flexible Cassette B Manual Air Eliminator Relief Valve C Bubble Trap D Clamp E Male Luer to Patient F Female Luer to Blood Fluid Source G Blue Guide Rail Figure 3 Warming set and bubble trap 3 0 Instructions for Use see figures 3 5 e Attach warming unit to IV pole and secure with clamp on side of unit e Plug the power cord into a properly grounded outlet e Remove the warming set from it s sterile packaging NOTE The flexible warming set is designed so it can be inserted into the warmer in only one orientation Orient the cassette so that the blue guide rail is inserted into the bottom of the warming unit Grasp each rail see figure 4 Stretch the flexible cassette slightly and insert the front end of the cassette into the front of the warming unit with the blue guide rail facing down Align the rails to each of the slotted openings2. soap water and a clean cloth 6 0 Functional Check and Safety Inspection To assure optimum performance dependability and safety the following should be performed every twelve months or as specified in the facility s preventive maintenance program Equipment or tools required O Any Gaymar D25340 series Blood Fluid Warming Set O Temperature measurement device e Gaymar D25340 Blood Fluid Warming Set and e Temperature sensor Gaymar catalog FWT1 and an ohmmeter accuracy 1 5 of reading maximum excitation current of 0QuA and the resistance temperature chart See figure 10 p 12 or e Any Gaymar D25000 series Blood Fluid Warming Set and e Waterproof temperature sensor meter with an accuracy of 0 3 across the range of 30 C to 60 C and a thermal time constant of 2 seconds or faster O Flow measurement device Gaymar catalog FWT2 flowmeter e Fluid source with calibrated flow meter and a minimum accuracy of 12 ml minute or e Fluid source with adjustable flow control Use a stop watch and graduated cylinder to adjust flow rate O Current Leakage Ground resistance tester O AC multimeter 6 1 Physical Inspection Check that the following items are in good condition and secure O Labels if peeling or missing Screws in cover Bubble trap receiver Power cord DU DD D IV pole clamp ENGLISH 6 2 Output Fluid Temperature Verification The FW600 Series Blood Fluid Warmer
3. ENGLISH Cc m Figure 4 Inserting the cassette Move hands to the rail protrusions and continue to insert the cassette until the clear guide rail is almost flush with the front of the unit The blue guide rail will protrude slightly for easy removal Figure 5 Setup instructions CAUTION When fully inserted the clear guide rail should protrude no more than 0 5 cm from the front of the warming unit Failure to fully insert the cassette may result in damage to the cassette ENGLISH 2 Close warming set input clamp Remove the protector from the female luer of the warming set and connect it to the male luer on the IV administration set Remove the protector from the male luer of the warming set To minimize temperature drop and priming volume remove unnecessary lead extensions at this time Invert the bubble trap 0 Open warming set input clamp Allow fluid to prime the set When the bubble trap fills to approximately 2 3 full close the output clamp Re invert the bubble trap and place it into the bubble trap receiver on the side of the warming unit A WARNING The bubble trap must be mounted and kept in a vertical position at all times Failure to do so could result in the introduction of air to the patient resulting in death or serious injury O Press the RUN STANDBY switch O on the front of the unit Upon successful compl
4. Medi Temp II REF FW600 Series Blood Fluid Warmer ENGLISH R chauffeur de sang liquide Medi Temp III s rie REF FW600 Riscaldatore per sangue fluidi Medi Temp III serie REF FW600 Recalentador de sangre y fluidos Serie REF FW600 Medi Temp III Aquecedor de Sangue Liquidos Medi temp III S rie REF FW600 Medi Temp III REF FW600 Serie Blut Fl ssigkeitsw rmer Medi Temp III REF FW600 Series bloed vloeistofverwarmer Medi Temp III serie REF FW600 varmeaggregat til blod v ske Medi Temp III varmeaggregat for blod v tska serie REF FW600 Medi Temp III REF FW600 sarjan veren nesteenlammitin Medi Temp III REF FW600 serie blod v skeoppvarmer Zvornua O guavons Aipatoc Yyewv Medi Temp III tng Lereds REF FW600 FRANCAIS ITALIANO ESPANOL PORTUGUES DEUTSCH NEDERLANDS DANSK SVENSKA SUOMI NORSK EAAHNIKA Operator s Manual Service Manual Manuel d utilisation Manuel d entretien Manuale per l operatore Manuale di manutenzione Manual del operador Manual de servicio Manual do Utilizador Manual de Servi o Bedienungs Wartungshandbuch Bedieningshandboek Onderhoudshandboek Operatsrh ndbog Servicemanual Instruktionsbok Servicehandbok Kayttajan k sikirja huoltok sikirja Brukerh ndbok serviceh ndbok Eyxetoi ro Xonong Eyxeroi ro Zuvrnononc CE 0086 P N 11294 000 11 01 ENGLISH Table of Contents Topic Indications for Use Product Description Instructions for Use Safety Systems Cleaning Functiona
5. d other fluids normally refrigerated can be rapidly warmed to user selectable temperatures of between 38 0 C 43 0 C at flow rates up to 300 ml min Room temperature fluids can be warmed at flow rates up to 500 ml min The disposable Blood Fluid warming sets are available in Standard Standard with Extensions Pediatric and High Flow models 2 1 Warmer The warming unit is designed to be IV pole mounted The device has no on off switch Connection to the AC supply is indicated by a green STANDBY mode indicator located on the front panel In STANDBY mode no power can be applied to the heater To begin normal operation the RUN STANDBY button must be pressed 2 When this occurs an LED temperature display located on the front panel will display the actual fluid temperature or the setpoint temperature in C The setpoint is user selectable from 38 0 C 43 0 C in 1 0 C increments by use of the SETPOINT switch on the front panel Also located on the front of the unit is a slot for insertion of the disposable warming set On the right side of the unit just below the IV pole clamp is a receiver for the disposable warming set s bubble trap 2 2 Disposable sets The Medi Temp III FW600 Series Blood Fluid warming unit is designed to be used only with Gaymar D25000 series disposable warming sets The following warming sets figure 2 are designed for use up to 300 mm Hg pressure Contact your local dealer for more information
6. death or serious injury A WARNING mH A Monitor the fluid level in the bubble trap frequently Bubbles released during heating are captured in the trap To refill the trap insert a sterile syringe into the valve and draw air out until the trap is two thirds 2 3 full Do not allow the bubble trap to go below one quarter 1 4 full Failure to monitor the fluid level in the bubble trap could result in the introduction of air to the patient resulting in death or serious injury ENGLISH Temperature at the End of Patient Line Setpoint 43 0 C Ambient 22 C 45 _ LA 40 a H 35 g 3 5 High Flow w 48 extension 20 input fluid 5 30 Standard w 48 extension 10 input fluid 25 20 DE rn a a a a a E E a ae 0 50 100 150 200 250 300 350 400 450 500 550 600 Flow in ml min Figure 6 Typical fluid temperature vs flow rate 3 1 Effect of Flow Rate on Fluid 3 2 Warming Set Removal Temperature The cassette cannot be removed from the warming Fluid temperatures exiting the patient line are affected unit while under pressure To remove the cassette by flow rate The following flow vs output fluid Close the warming set input clamp first while temperature curve is typical for the FW600 series leaving the output clamp open warming unit See figure 6 above 2 Close the warming set output clamp NOTE Output fluid temperature for this curve is measured at the
7. end of the patient line 3 Following steps and 2 will allow fluid to drain from the cassette Gently pull on blue guide rail to remove cassette from warming unit 4 Dispose of warming set per facility protocol A CAUTION Failure to drain cassette will make it difficult to remove Forcing the cassette out may cause it to rupture ENGLISH A 4 0 Safety Systems 4 1 Over Temperature Protection A backup system within the warmer is independent of the main controller and monitors fluid temperature continuously If the output fluid temperature exceeds 45 0 C the backup system will immediately interrupt power to the heaters If the over temperature condition is a temporary occurrence as a result of a sudden change in flow rate the display will alternately flash HI and the fluid temperature When the fluid temperature returns to acceptable temperature levels normal operation will resume If however the backup system detects that the over temperature condition is a result of a failure of the main controller an audible alarm will sound the RFU REMOVE FROM USE indicator will light and the device will shut down If this occurs immediately stop the fluid flow discard the warming set and contact your dealer for service 4 2 Self diagnostics Each time the warming unit is switched from STANDBY mode to RUN mode a self test is initiated If the backup system is not functioning properly an error message will be disp
8. etion of self diagnostics the display will flash the setpoint for approximately 3 seconds then begin warming the fluid to the selected temperature The setpoint most recently used is retained in memory even after power is removed To select an alternate setpoint first press the 43 SETPOINT switch IS momentarily This will cause the setpoint to be displayed and flash for approximately 3 seconds While the display is flashing the setpoint the user may select any setpoint between 38 0 C and 43 0 C in 1 0 C increments by repeatedly pressing the SETPOINT switch NOTE holding down the SETPOINT switch indefinitely will not increment the setpoint After the selection has been made the display will continue to flash this setpoint for approximately 3 seconds then revert to displaying the actual fluid temperature The setpoint can be checked at any time during the procedure by momentarily pressing the SETPOINT switch If required connect an extension for patient connection O Purge air from remaining length of tubing by opening output clamp and allowing fluid to flow A WARNING e All air must be removed from the fluid lines prior to connecting to the patient e Monitor the fluid lines to ensure they are air free Never administer fluids if there are air bubbles in the line between the bubble trap and the patient connector Failure to do so could result in the introduction of air to the patient resulting in
9. he IV pole clamp The resistance value should not exceed 0 50 ohms 6 5 Current Leakage Test Measure the maximum earth leakage current ground open Measure all combinations of line polarity with neutral open and closed Values should not exceed the following FW600 neutral closed 150uA FW600 neutral open 200A FW603 neutral closed 250yuA FW 603 neutral open 300uA 7 0 Troubleshooting ENGLISH Symptom Display alternately flashes LO and the fluid temperature Probable causes Output fluid temperature has not yet reached 34 C Required action Allow unit to run for 2 minutes If temperature does not increase remove from use and request service Display alternately flashes HI and the fluid temperature A transient disturbance such as a sudden change in flow rate has caused the fluid temperature to rise above 43 C NONE unit will resume normal operation when temperature drops below 43 C Audible alarm sounds and display flashes LO and the fluid temperature Output fluid temperature has dropped below 34 C Allow unit to run for 2 minutes If temperature does not increase remove from use and request service Audible alarm sounds and display indicates FA_ The electronic diagnostics have detected an internal problem Remove from use and request service Audible alarm sounds continuously and yellow RFU light is lit Cassette is difficu
10. is factory calibrated at a flow rate of 100 ml min with a set point of 43 0 C To verify the output fluid temperature is correct The ambient room temperature must be between 20 C to 24 C 2 Connect the test setup see figure 7 Attach the Gaymar FWT I temperature sensor to the output of the bubble trap Alternate method Put a hole in the top of the bubble trap and insert a temperature measurement device through this hole Make certain sensor is completely submerged in fluid then seal the hole in the bubble trap 3 Connect the FWT2 flowmeter or flow measurement control device to the output of the FWT I temperature sensor Alternate method If using the sensor in the bubble trap method connect the FWT2 flowmeter or flow measurement control device directly to the output of the bubble trap 4 Flow room temperature water through the warmer at 100 ml min cc min Verify that the bubble trap is maintained 1 2 to 2 3 full 5 Turn the warmer on Adjust the SETPOINT to 43 0 C Allow it to run for 10 minutes 6 Verify that the output water temperature is 43 0 C 1 1 C If using the FWT I temperature sensor and an ohmmeter verify that the resistance is within 1019 1112 ohms If temperature or resistance values are not met check setup and repeat test If still not within range contact your dealer for service This device is factory calibrated and cannot be field adjusted 6 3 Overtemp Protection Verificatio
11. l Check Safety Inspection Troubleshooting Technical Specifications Before you begin Important Before using the Medi Temp III FW600 Series Blood Fluid Warmer please read and understand this Operator s Manual and the SAFETY PRECAUTIONS prior to use If you have any questions please contact your local dealer for assistance Warranty The Medi Temp III FW600 Series Blood Fluid Warmer is warranted free of defects in material and workmanship for a period of one I year The Disposable Warming Sets are warranted free of defects in material and workmanship for a single application A copy of the warranty is available upon request Gaymar disclaims all implied warranties including but not limited to the implied warranties of merchantability and of fitness for a particular purpose ENGLISH 1 0 Indications for Use This device is intended to aid in the prevention of inadvertent hypothermia during administration of blood blood products and other fluids A l l Safety Precautions DANGER Risk of electric shock No user serviceable parts inside A WARNING All air must be removed from the fluid lines prior to connection to the patient Monitor the fluid lines to insure they are air free Never administer fluids if there are air bubbles in the line between the bubble trap and the patient connector Monitor the fluid level in the bubble trap frequently Bubbles released during heating are captured in
12. layed and the unit will shut down In addition self tests are routinely performed during RUN mode to ensure continued safe operation of the warming unit 4 3 Control Alarm LO If the warming unit senses a fluid temperature less than 34 0 C the audible alarm will chime and the display will alternately indicate the symbol LO and the actual fluid temperature Exception The unit will not alarm until the fluid pey temperature has initially surpassed the 34 0 C threshold eso 5 0 Cleaning CAUTION e Clean inside of cassette slot with disposable brush Carefully flush using squeeze bottle with water Replacement cleaning kit P N 78350 000 Do not immerse the warmer in cleaning or disinfectant solutions Do not submerge it in e Apply a disinfectant such as 10 chlorinated liquids it is fluid resistant not fluid proof bleach solution chlorinated bleach with 5 25 sodium hypochlorite to both the outside of the unit and the cassette slot and allow to dry Immersion could result in malfunction or equipment damage A CAUTION Perform the following care and cleaning between patient use or per facility protocol The warming unit should be cleaned if any e Unplug unit prior to cleaning fluid or foreign substance has entered the cassette slot Failure to keep the cassette e To clean the external surfaces of the warmer use slot clean could impede cassette a non abrasive cleaning solution such as warm insertion
13. lt to insert into warming unit Internal fluid temperatures have exceeded 45 C and backup system has been activated Cassette primed prior to insertion Inside slot of warming unit may have contamination on the heater plates Stop fluid flow discard cassette and request service Drain cassette and reinsert Clean inside of unit by following cleaning procedure section 5 0 Cassette is difficult to remove from warming unit Cassette is still pressurized Close input clamp and open output clamp Allow fluid to drain Figure 8 Troubleshooting chart GAYMAT GAYMAR INDUSTRIES INC 10 Centre Drive USA TEL Orchard Park NY 1 800 828 7341 14127 2295 716 662 2551 USA USA FAX 1 800 993 7890 716 662 0748 International 716 662 8636 TEL 716 662 0730 FAX
14. n Proper operation of the overtemp protection system is verified each time the unit is switched from STANDBY to RUN mode Therefore periodic testing of this system is not necessary However the following procedure may be used to force an OVERTEMP condition in order to observe that the overtemp protection system works ENGLISH Water 20 24 C Gaymar Resistance temperature Catalog chart See p 12 FWT1 et D Ohm meter a Alternate temperature measurement method To use your own temperature measurement device Ces i Gaymar Catalog N FWT2 Alternate flow control method Needle valve Measure and adjust flow rate using Cut hole drill if necessary in bubble trap of warming set insert sensor to the bottom of bubble trap without blocking liquid flow and seal hole graduated cylinder S and stopwatch Figure 7 Test setup I Insert any D25000 series Warming cassette into the warming unit Using hot tap water 46 C 50 C flow hot water through the cassette for approximately 1 3 minutes 2 Connect AC power to the warming unit The device should immediately sound the audible alarm and light the RFU light 6 4 Ground Resistance Check Use a current leakage ground resistance tester to measure the resistance between the ground pin on the power plug and the mounting screw on t
15. the trap To refill the trap insert a sterile syringe into the valve and draw air out until the trap is 2 3 full Do not allow the bubble trap to go below one quarter 1 4 full The bubble trap must be kept mounted and in the vertical position at all times Failure to follow the above warnings could result in the introduction of air to the patient Introduction of air to the patient could result in death or serious injury A CAUTION US Federal law restricts this device to sale by or on the order of a physician Do not immerse in cleaning and or sterilization solution Do not submerge or soak unit it is fluid resistant not fluid proof For grounding reliability of the Blood Fluid warmer plug only into a properly grounded outlet The RUN STANDBY switch does not provide isolation from the mains Isolation from the mains IEC 601 1 can only be achieved by disconnecting the cord from the mains SETPOINT switch button RUN STANDBY switch Cassette slot ENGLISH REMOVE FROM USE indicator STANDBY indicator lV pole clamp Bubble trap receiver Figure FW600 series Blood Fluid Warmer 2 0 Product Description The Medi Temp III FW600 Series Blood Fluid Warmer is a dry heat device designed for safe and rapid warming of blood blood products and other fluids through the utilization of disposable blood fluid warming sets The warmer does not provide fluid flow rate control Blood blood products an
Download Pdf Manuals
Related Search