QuickThaw™ Plasma Thawing System Operation Manual
Contents
1. de Helmer E N T Plasma Thawing System Operation Manual QuickIhaw 4 Helmet Model Version DH2 A DH4 A DH8 A HELMER SCIENTIFIC 14400 Bergen Boulevard Noblesville IN 46060 USA m C PH 1 317 773 9073 FAX 1 317 773 9082 USA and Canada 800 743 5637 360094 1 M ISO 13485 2003 CERTIFIED Helmer Document History Revision Date CO Supersession Revision Description Supersedes A B C D E F G Revised layout for ease of navigation and locating information H l J K M 16 MAY 2014 9492 M supersedes L Removed 0086 mark from manual L 08 MAY 2013 8409 Date submitted for Change Order review Actual release date may vary 360094 1 M Helmer Contents Section General Information ener n n es 3 1 Aboutthis Manual ooooocccccncnccc a 3 1 1 Intended Audience 3 1 2 Model References llle eee ee eee 3 1 3 Copyright and Trademark ous ence ies oe sur ree uio dera pibes dador dedicara 9 nn 3 21 Prod ctLabslS EEE ee e Ew ee EE e ee 3 2 2 SA Pe d 3 General Recommendations 0000 cee ee eee 4 31 dJmended S6 rasa erare renews oreo dee Pee ee ea E ON rd ee NUR RR ee ee deere eee bees 4 3 2 General Use x k rer cokes we dw CAS aw a beer ew Boy area 4 So IWMANIZOAGING stan cotta e ads nd A8 bc dace Vo DOR QU ness Shand e Bae qe orn qi dod OR di Sa es es 4 4 DSDECIICAUONS escasas 44044 Gea be eee eee dead a a ara c2. SET button until the display reads HO Press the TIME SET button again and the cycle will finish its initial programmed time 360094 1 M 10 gt Helmer Operation 8 6 2 8 6 3 8 7 360094 1 M Start a Cycle Confirm the chamber has been filled to the appropriate level Confirm the water temperature stabilized at temperature setpoint Enable or disable agitation motion depending on your organization s specific needs Load overwrapped bags into basket s with security snap s as needed For each basket press the CYCLE TIME button to select the desired time Press the CYCLE START button to lower basket and start the thaw cycle aoarh WN NOTE One DH4 and DH8 models the cycle time cycle start and lift out for each basket is controlled individually Stop Pause or Resume a Thaw Cycle When a thaw cycle is stopped or paused the basket lifts out of the chamber before the thaw cycle is completed Press the LIFT OUT button to raise the basket and temporarily pause the thaw cycle The remaining time is displayed on the cycle time indicator Press the LIFT OUT button again to resume the thaw cycle The basket is lowered into the chamber and the agitation motion resumes The hold HO setting may be selected while the thaw cycle is paused LIFT OUT button pressed Complete a Thaw Cycle When a thaw cycle reaches the end of its programmed time setting the basket stops agitating lifts out a
3. snap 8 6 Thaw Cycle Functions N CAUTION Keep fingers and clothing away from basket s while in motion Ifa temperature alarm is active a thaw cycle cannot be initiated until the alarm condition is cleared gt Alift out malfunction alarm for one basket will not prevent the other basket from performing a thaw cycle DH4 and DH8 models gt Allow the water temperature to stabilize at the setpoint between thaw cycles Button Button Name Function Te Set thaw cycle time in minutes CYCLE TIME Extend thaw cycle time Select the hold HO setting CYCLE START Start a thaw cycle Pause a thaw cycle in process press to raise the basket ES LIFT OUT gt Resume a paused thaw cycle press to lower the basket gt Stop a thaw cycle 8 6 1 Start a Thaw Cycle When the thaw cycle is started the lift out system closes the basket and lowers it into chamber If agitation motion is enabled the basket begins to agitate after the basket reaches the bottom of its travel The remaining cycle time in minutes is displayed on the cycle time indicator located on the control panel Programmed time settings of 0 3 5 8 10 12 14 16 18 20 and 25 minutes as well as a hold HO setting are pre programmed in to the timing system gt Pressing the TIME SET button advances through each pre programmed time setting To indefinitely extend a thawing cycle that is already in progress press the TIME
4. values affects plasma thawer operation Do not change values unless instructed in product documentation or by Helmer Technical Service By default the low temperature alarm is not enabled If the Low Temperature alarm is enabled follow regulations for your organization to determine the appropriate temperature setting gt Ensure the Low Temperature alarm setting is no higher than 30 0 C The monitoring and control system has alarms which activate if the temperature is too high or too low if the Low Temperature alarm is enabled The setpoints for these alarms may be viewed and or changed using the temperature controller Temperature controller display The High Temperature alarm setpoint AL hi specifies the temperature at which the High Temperature alarm should activate If the temperature detected by the temperature control sensor is greater than or equal to this value the alarm activates The Low Temperature alarm setpoint AL Lo specifies the temperature at which the Low Temperature alarm should activate If the temperature detected by the temperature control sensor is less than or equal to this value the alarm activates View or change parameter values NOTE Default high temperature alarm setpoint is 37 6 C Low temperature alarm setpoint is disabled by default setpoint is 0 0 C gt When setting alarm setpoints maintain at least a 1 0 C difference above or below the plasma thawer setpoint When the
5. abel Description A Power indicator LED E CYCLE START button B POWER button F Cycle time indicator C MUTE button G LIFT OUT button D CYCLE TIME button H Temperature controller 10 2 Chamber muU o U Label Description Label Description A Chamber D Basket B Finger knob E External thermometer access port C Lift out system 360094 1 M 15 Helmer Operation 10 2 1 Thawer Basket Helmer M MOON E a DH8 basket shown with 2 plasma bags in standard overwraps Label Description Label Description A Basket D Basket divider DH8 B Bearing E Overwrap bag C Tab F Security snap 10 3 Rear B Vent D Power connector END OF MANUAL 360094 1 M 16 HELMER SCIENTIFIC 14400 Bergen Boulevard Noblesville IN 46060 USA PH 1 317 773 9073 FAX 1 317 773 9082 www helmerinc com E Helmer S C E N T F C
6. be used The plasma bag Is placed inside the overwrap bag and the overwrap bag is attached to the basket Overwrap bags provide the following benefits Secure the plasma bag to the basket Protect the plasma bag from water borne contaminants Ifthe plasma bag breaks the contents will not contaminate the water bath NOTE Use only 1 overwrap bag of the appropriate size per plasma bag The following recommendations will aid in thawing plasma bags Use security snaps on smaller bags that tend to float Load plasma bags together that require the same thaw time gt When loading 2 bags on same side of the basket in DH8 models place thicker bag in the front most compartment Load the bag s 1 Insert plasma bag into appropriate size overwrap bag 2 On control panel press the LIFT OUT button to raise and open basket LIFT OUT button 3 DH8 models Remove the basket divider if a jumbo or wide bag is loaded gt Squeeze sides of the divider together and pull divider away from basket Removing divider from DH8 basket gt Helmer Operation 4 Place overwrapped plasma bag in basket Hook the slot at the top of the overwrap bag over the tab on the basket For large overwraps ensure both slots are hooked over the tabs 5 Insert a security snap through top set of holes on the basket compartment Push the snap toward the basket until it snaps against the overwrap bag Bag in standard sized overwrap bag with security
7. ble or Disable Agitation Motion cc RR urn 12 8 9 Mute an Audible Alarm e e sake OHA CR OR EP RO Reac cue dede ae RR Rn 12 9 Temperature Monitor Setpoints 0ooocococno rne 12 9 1 Change the Chamber Temperature Setpoint aaaea 12 9 2 View or Change Temperature Alarm Setpoints llli 13 10 COMPONENES 53x58 aca x a cac A dee GA RACE eee Reed e E CR RC ale ag 14 10 4 Frontand Slides 14 VIT Control Panele sirsa ane oo oe rd ee ae eh aS Ge ee ae eS ee ee eee ad ee a 15 10 2 Faber oe oe we Ys eee oe da y cn Bee eee ee wi ae a SL ee on eae ee 15 10 2 1 Thawer BasKGL cua eX RC CES ed Be Sd de OH ORES EOD PEE EONS Gr AEA OER LSS 16 OU RO vrs e e ee ee ee A OG a a ee ee Oe po Soe ee ee 16 360094 1 M E Helmer General Information Section General Information 1 1 1 2 1 3 2 1 2 2 About this Manual Intended Audience This manual is intended for use by end users of the plasma thawing system and authorized service technicians Model References Generic references are used throughout this manual to group models that contain similar features For example DH models refers to all models of that type DH2 DH4 DH8 This manual covers all plasma thawing systems which may be identified singly by their size or by their series DH Copyright and Trademark Helmer and Rel i are registered trademarks or trademarks of Helmer Inc in the United States of Amer
8. de of the plasma thawer Application VwvwvYv 360094 1 M 4 Helmer 5 5 1 5 2 5 3 360094 1 M References and Compliance Alarm Reference General Information If an alarm condition is met an alarm activates The following table indicates if an alarm is audible A or visual V Messages for visual alarms if applicable appear in the table as well Alarm Alarm Type High Temperature A V AL on temperature controller E1 on all cycle time indicators Low Temperature A V AL on temperature controller Lift Out System A V E2 on affected cycle time indicator Malfunction Low temperature alarm is available but not used Regulatory Compliance Pollution degree 2 for use in USA and Canada only This product is certified to applicable UL and CSA standards by a NRTL This device complies with the requirements of directive 93 42 EEC concerning Medical Devices as amended by 2007 47 EC Sound level is less than 70 dB A WEEE Compliance The WEEE waste electrical and electronic equipment symbol right indicates compliance with European Union Directive WEEE 2002 96 EC and applicable provisions The directive sets requirements for labeling and disposal of certain products in affected countries When disposing of this product in countries affected by this directive Do not dispose of this product as unsorted municipal waste gt Collect this product separately U
9. e into the drain port The coupling valve will click when it is properly seated Water immediately begins to drain from the chamber 5 After the water has drained from the chamber release the drain tube Press down on the release button on the coupling valve Pull the coupling valve out of the drain port Determine the Correct Thaw Time Thaw time varies by bag type and how the bags were manipulated when frozen flat or folded The table below indicates median thaw times for bags previously stored at 30 C Manner Median Thaw Frozen Time Minutes 10 mL to 15 mL cryoprecipitate 5 250 mL standard 10 250 mL thick plastic 16 250 mL standard 17 300 mL standard 14 500 mL jumbo apheresis Flat 18 Plasma Bag Size and Type gt Helmer Operation 8 5 Load Bags N CAUTION Do not manually lift the baskets out of the chamber Manually lifting baskets will 360094 1 M damage the system Press the LIFT OUT button to raise the baskets Press the LIFT OUT button only if the baskets are installed The basket must be installed for the lift out system to operate correctly gt DH2 basket holds 2 standard bags DH4 uses 2 ofthe same basket used in the DH2 for a total capacity of 4 compartments DH8 basket holds 8 standard bags NOTE On the DH8 the divider between compartments on each side can be removed to hold jumbo or wide bags When thawing a plasma bag of any type or size a plasma overwrap bag must
10. ica Copyright O 2013 Helmer Inc All other trademarks and registered trademarks are the property of their respective owners Helmer Inc doing business as DBA Helmer Scientific and Helmer Safety Includes general safety information for plasma thawing system operation Product Labels Caution Risk of damage Earth ground terminal to equipment or danger to operator Caution Hot surface Protective earth ground terminal Caution Shock electrical hazard Avoiding Injury Review safety instructions before installing using or maintaining the equipment Before moving unit ensure chamber water has been removed Never physically restrict any moving component gt Avoid removing electrical service panels and access panels unless so instructed Use supplied power cords only N CAUTION Decontaminate parts prior to sending for service or repair Contact Helmer or your 360094 1 M distributor for decontamination instructions and a Return Authorization Number els Helmer General Information 3 General Recommendations 3 1 Intended Use Helmer plasma thawing systems are intended for thawing frozen blood products and other medical biological and scientific products 3 2 General Use Allow plasma thawer to come to room temperature before switching power on During initial startup low temperature alarm may sound while plasma thawer reaches operating temperature 3 3 Initial Loading Allow chamber temperatu
11. is i CR GR 4 5 References and Compliance 2 0000 c eee ehh rh 5 5 1 Alarm Reierence vs us dunes ra RR Dae EUR a ea made dn RUE oe ed we MED G a di 5 5 2 Regulatory Compliance 2229 ceca ad e bod Ge iaa donee e Leo oS SG Gade pe s eee ae oo 5 5 3 WEEE Compliance ua auris soda decedit dr mete gob derbi areas Odean aclara ara dra ay carers on ap 5 O Installation cocer ara a ad 6 6 1 Location Requirements soon hwo reis de a se Ri hee e a RAS e Ee 6 6 1 1 Placement gaver ET oot ethan ee ke ke ende ae ees od Sawer ET 6 6 2 Install External Thermometer Optional nnana naaa aaaea rs 6 7 Maintenance Schedule 0 0 0 cee ee ee ee 6 Section Il Operation s sae ranas ewe ee ee AR ee eee I RR RR 7 8 General Operation 0 0 0 eee 7 MEME D ES sea 7 8 2 Pill the Chamber La is oa a we dede aid ac ue dde ici 7 So Drain the CAND scene usd uan os eee wane Er Sok Eee eee ee weds 8 8 4 Determine the Correct Thaw Time 0 00000 ccc RR RR RR ee es 8 9 9 OGG Bags sire ce da eerdae eds eta EE EE NE ee ad 9 8 6 Thaw Cycle Functions x 3 o sets dines Sud a Sos ood bead desa e e Ree ees edad qd ed EN e 10 9 5 Stana GLEN EG usage dri Ez nese pusiera var bed eb ae lo ia es 10 8 6 2 Stop Pause or Resume a Thaw Cycle nananana naaa aaa een 11 8 6 3 Complete a Thaw Cycle lille hn 11 S P UnOoSd Bags 21200 desverre codes eens us Boo dU dE aet disp md Tn t 11 8 8 Ena
12. ly or only by designated service personnel Frequency Task Leery Quarterly Annually As Needed Clean the chamber and basket DH2 or baskets DH4 and DH8 Clean the exterior Clean the fan 100 V DH8 Lubricate moving parts Check temperature calibration for the temperature controller readout Recalibrate if necessary Test the high temperature alarm Check the bearings on each basket for wear Replace if necessary gt Helmer Operation Section Il Operation 8 8 1 8 2 360094 1 M General Operation Initial Start Up 1 Plug the power cord into a grounded outlet that meets the electrical requirements on the product specification label 2 Press the AC ON OFF button to power the plasma thawer ON NOTE The AC ON OFF switch also controls the fan on 100 V DH8 models High temperature alarm activates quickly when chamber is empty Fill the Chamber Two fill lines are marked on the rear wall of the chamber The lines indicate the maximum water level for the following applications Upper line maximum level for thawing random bags Lower line maximum level for thawing apheresis bags Chamber fill lines NOTE gt Determine the type of water to be used tap or distilled according to your organization s requirements Use of a bacterial growth inhibitor such as Helmer CleanBath is recommended Do not use deionized water as it may be corrosive to the chamber and baskets Add water to
13. nd opens An audible alert sounds to indicate the thaw cycle has completed and the cycle time indicator resets to the previously selected time setting Unload Bags CAUTION gt Do not manually lift the baskets out of the chamber Manually lifting baskets will damage the system Press the LIFT OUT button to raise the baskets Press the LIFT OUT button only if the baskets are installed The basket must be installed for the lift out system to operate correctly Unload the bag s 1 On control panel press the LIFT OUT button to raise and open basket LIFT OUT button 2 Remove the security snap from the basket Unhook the slot at the top of the overwrap bag from the tab on the basket Remove the overwrap bag from the basket Remove the plasma bag from the overwrap bag Discard the overwrap bag 0O A Q 11 gt Helmer Operation 8 8 8 9 9 1 360094 1 M Enable or Disable Agitation Motion Default is enabled Agitation reduces thaw time It is controlled with the switch located at the rear of thawer For DH4 and DH8 top and bottom switches control right and left basket agitation respectively Agitation switches Mute an Audible Alarm Audible alarms can be muted The temperature controller will still continue to flash an alarm message if the alarm has been muted To mute an audible alarm press the MUTE button Mute button Pressing the MUTE button silences alarms for both baskets DH8 models If a sec
14. ond audible alarm activates while the first audible alarm is muted the second alarm will be muted as well When an alarm is muted the duration is indefinite Muting is cleared under the following conditions The condition that triggered the alarm is resolved AC power to the plasma thawer is switched off Temperature Monitor Setpoints Change the Chamber Temperature Setpoint NOTEQ Do not change any other temperature controller parameter unless instructed in this manual or by Helmer Technical Service The default chamber temperature setpoint is 36 5 C If the chamber temperature falls below the setpoint the temperature controller activates the chamber heater until the setpoint is reached The chamber heater and sensor are located underneath chamber Change the setpoint 1 Determine setpoint if other than default 2 Ihe chamber temperature appears on the display NOTE The displayed temperature may differ from the setpoint especially if chamber temperature has not stabilized at the setpoint 12 gt Helmer Operation 9 2 360094 1 M Temperature controller display 3 Press and hold the button The setpoint value is displayed 4 Press the UP or DOWN buttons to change the setpoint value The setpoint value is adjusted up or down in increments of 0 1 C 5 Release all buttons to exit the setpoint value adjustment New setting is saved View or Change Temperature Alarm Setpoints NOTE Changing parameter
15. re is no interaction for 60 seconds the temperature controller exits program mode 13 gt Helmer Operation 10 10 1 360094 1 M 1 Enter Level 1 program mode a Press and hold the UP and DOWN buttons simultaneously for approximately 3 seconds b tunE and oFF flash on the display c The temperature controller is now in Level 1 program mode 2 Select the parameter to be changed a Press and release the UP or DOWN buttons until the desired parameter flashes on the display b For the High Temperature setting select the AL hi parameter c For the Low Temperature setting select the AL Lo parameter 3 Change a parameter value a Press and hold the button b Press the UP or DOWN buttons to change the parameter value 4 Release all buttons to exit the parameter New settings are saved 5 Exit program mode a Press and hold the UP and DOWN arrow buttons simultaneously for approximately 3 seconds or b the current chamber temperature is displayed Components Front and Sides LE OO Helmer Front and left sides 115 V DH4 model shown Label Description Label Description A Fan DH8 100 V models F Control panel B Drain port G Cover C Drain tube with coupling valve H Basket D Drain port cover Plasma overwrap holder E Product specification label 14 Helmer Operation 10 1 1 Control Panel A B E D C D E Control panel Top DH2 model Bottom DH4 and DH8 models Label Description L
16. re to stabilize at the setpoint before thawing frozen product 4 Specifications DH2 DH4 DH8 Physical Height Baskets Lowered 16 25 413 mm Height Baskets Raised 23 00 584 mm 23 00 584 mm Width 21 75 553 mm Depth 15 50 394 mm 15 50 394 mm 22 50 572 mm Weight 38 lbs 17 kg 58 lbs 26 kg 74 lbs 34 kg Chamber Volume 2 2 gal 8 2 L 4 75 gal 18 L 8 5 gal 32 L External Port Standard for external thermometer Electrical Input Voltage and Frequency 100 V 50 Hz 115 V 50 60 Hz 230 V 50 60 Hz Voltage Tolerance 10 5A 100 V 10A 100 V 15A 100 V Circuit Breakers 4 A 115 V T A 115 V 15A 115 V 2 A 230 V quantity 2 4 A 230 V quantity 2 6A 230 V quantity 2 3 0A 100 V 8 0A 100 V 12 0 A 100 V Power Consumption 1 2 5 A 115 V 6 0A 115 V 10 0A 115 V 1 25 A 230 V 3 0 A 230 V 5 0A 230 V Power Source Varies refer to product specification label Control and Monitoring Interface Integrated temperature control monitoring and display Alarms High temperature low temperature lift out malfunction Environmental Indoor use only Altitude maximum 2000 m Ambient temperature range 15 C to 32 C 59 F to 90 F Relative humidity maximum for ambient temperature 80 for temperatures up to 31 C 88 F decreasing linearly to 50 at 40 C 104 F 1 Power consumption is measured in full load Amperes 2 Product specification label is located on the left si
17. se collection and return systems available locally For more information on the return recovery or recycling of this product contact your local distributor E Helmer General Information 6 6 1 6 2 360094 1 M Installation Location Requirements Has a sturdy level surface Has a grounded outlet meeting national electric code NEC and local electrical requirements Is clear of direct sunlight high temperature sources and heating and air conditioning vents Minimum 8 203 mm above Access to a water supply Adjacent to a sanitary drain or waste water container Meets limits specified for ambient temperature and relative humidity vvwvvvovv NOTE If possible drain or waste container should be located on same side as drain port Placement CAUTION Ensure chamber has been drained before moving gt Unplug unit from AC power before moving Install External Thermometer Optional Install the external thermometer according to the manufacturer s documentation If using a Helmer DT1 digital thermometer refer to the instructions on the CD shipped with the plasma thawer Maintenance Schedule Maintenance tasks should be completed according to the following schedule Refer to the service manual for more detail on the various tasks NOTE These are recommended minimum requirements Regulations for your organization or physical conditions at your organization may require maintenance items to be performed more frequent
18. the chamber 1 Ensure the chamber and drain are free of debris or contaminants 2 Ensure the drain tube is not connected 3 Fill the chamber to the appropriate level 4 Add bacterial growth inhibitor optional gt Helmer Operation 8 3 Drain the Chamber N CAUTION Disconnect the plasma thawer from AC power before draining the chamber 8 4 360094 1 M Do not move the plasma thawer when the chamber is filled or if the plasma thawer is connected to AC power The plasma thawer has a drain port to drain water from the chamber The drain valve is integrated into the drain fitting on the side of the plasma thawer The drain valve remains closed until the drain tube is connected to the valve When the drain tube is connected the chamber begins to drain immediately The drain coupling must be installed on the drain tube before the drain tube can be connected to the drain valve The 90 elbow may be installed in the drain tube to facilitate convenient routing of the drain tube Left Drain port with coupling valve and drain tube connected release button identified with arrow Middle Drain tube with coupling valve installed Right 90 elbow fitting Drain water from the chamber 1 Press the AC ON OFF button to power the plasma thawer OFF 2 Disconnect the power cord from AC power 3 Place the open end of the drain tube into a waste container or sanitary drain 4 On the opposite end of the drain tube push the coupling valv
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