Celleration orporated CP-80033 Ultrasound Healing Therapy User Manual

Celleration Incorporated Ultrasound Healing Therapy

User Manual

GENERATOR 1 Generator 2 Power Switch (Back of Generator) 3 Generator Power Cord 4 Peristaltic Pump 5 Tubing Guides 6 Adjustable Hook 7 Indicator Light 8 Treatment Wand Connector 9 Treatment Wand Cradle10 USB Port/Cover TREATMENT WAND11 Treatment Wand12 Display Screen13 Keypad14 Treatment Wand Cable with Connector15 Tubing Channel16 Treatment ON/OFF Button (Trigger)17 Treatment Wand Tip APPLICATOR18 Applicator19 Tubing-Cable Clip20 Tubing Clamp21 Infusion Tubing22 Tubing Spike23 Tubing Spike Protective Cover PLEASE READ INSTRUCTIONS BEFORE USE. UltraMIST™ SystemULTRAMIST™ SYSTEM INSTRUCTIONS FOR USEOther Materials Required• 0.9% Normal Saline 100cc - 1000cc bag• Germicidal wipes for cleaning/disinfecting• Absorbent padsCaution: Rx Only. This medical device is to be operated by a healthcare professional in accordance with the instructions for use.Generator Treatment WandApplicator123456789101112 1314151617181920212223PL-61044_B 1
Clean the UltraMIST System prior to and after each treatment session with the Power Switch in the “off” position.CLEANING THE ULTRAMIST SYSTEM Do not sterilize the treatment wand including tip with steam, ETO, radiation, gas/plasma, or cold sterilants. After completion of the UltraMIST treatment, repeat the cleaning process.PREPARING THE PATIENT FOR TREATMENT WITH THE ULTRAMIST SYSTEMCollect all required materials (generator, treatment wand, applicator, IV saline, germicidial wipes, absorbent pads and gloves). Use facility approved Infection Control Procedures throughout the treatment session. Treatment with the UltraMIST System will require a clean environment. Depending on the wound location, position the patient in a comfortable position for treatment.WARNING: The UltraMIST applicator is designed as a single patient-use disposable unit to avoid contamination. Do not re-sterilize or reuse applicators. Re-using the applicator and/or saline may result in infection and degraded performance.DESCRIPTION & INDICATIONS FOR USEDescription: The UltraMISTTM System delivers low frequency ultrasound to the treatment site using a noncontact saline mist. Indications for Use: The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria. Contraindications: Do not use near electronic implants/prosthesis (e.g. Near or over the heart or over the thoracic area if the patient is using a cardiac pacemaker); on the lower back during pregnancy or over the pregnant uterus; over areas of malignancies. Potential Complications: Tingling, redness.CONTRAINDICATIONS & POTENTIAL COMPLICATIONSPrior to treatment, clean the entire system using facility approved infection control procedures. PL-61044_B 21234Remove soiled dressings and discard all contaminated materials (gloves, dressings, pads) prior to UltraMIST treatment. Place an absorbent pad under the portion of the patient being treated to collect the saline runoff.Measure the area of the wound to be treated.56712ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Preparing the UltraMIST System continued on next pagePREPARING THE ULTRAMIST™ SYSTEMWiththepowerswitchinthe‘o’posion,plugthesupplied generator power cord into the back of the generator and into an electrical outlet.1Ensurethetreatmentwandcableisaachedandfullyseated to the front of the generator by aligning the red mark on the cable with the red mark on the connector.2Turn the power switch located on the back of the generatortothe‘on’posion.3Aertheself-testiscompleted,usethekeypadonthetreatment wand to select the number of wounds to be treated. Press toconnue.4Use the keypad to enter the size of each wound to be treated per the screen prompts.5The total saline requirement for the combined treatment area is displayed (approximately 100mL for every 25 cm2). Select the appropriate saline bag size. Press  to connue.6The display screen will ask for the applicator to be loaded. Remove applicator from packaging and press the applicator onto the treatment wand. Ensure the applicatorisfullyseatedpriortousewiththemetalpvisible in the center. 7Note: Aer the set up is complete, DO NOT remove the applicator unl the treatment has been fully concluded. This is a single use product that once removed will need to be replaced with a new applicator.UpDownBack Select(Forward)-- Treatment TimeWound Number ---- Wound SizePL-61044_B 320-29ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PREPARING THE ULTRAMIST™ SYSTEMAllowthesalinetorunthroughtheapplicatortubingunlsalineisnotedatthedistalp.Closethetubingclamp.10Ifulizingtheadjustablehook,posiongeneratorneartheedgeofaatworksurface(i.e.tabletoporcart).Extendthehookbeyondtheedgeandaachthesalinebag.Adjustposionasnecessarysothesalinebaghangsfreelyand the generator is stable. 11The display screen will ask for the saline pump to be loaded. Open the saline pump door. 12Loop the applicator tubing from the saline bag through thesalinepumpfromletoright,centerontubingguides, and close the pump door. Leave enough tubing toallowthesalinebagtohangfreelywiththemajorityofthe tubing between the pump and treatment wand.13Openthetubingclamp.Salinewillnotowunlthetreatmenton/obuonisiniated.14The system is now set up and ready for treatment. Note: Saline will only ow in conjuncon with ultrasound delivery.-- Total Treatment TimeNumber of -- Wounds-- Treatment Time for Wound 1PL-61044_B 4Remove saline bag from outer packaging. Remove the protecvecoverfromapplicatortubingspikeandfromsaline bag port. Insert spike fully into saline bag. 9Insert applicator tubing into the treatment wand tubing channelandaachthetubingcliptothetreatmentwandcable. Place treatment wand in cradle once completed. 8ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USETubing Guides
TREATING THE PATIENT WITH THE ULTRAMIST™ SYSTEMThe treatment wand should be oriented so that it is perpendicular to the wound with the leading edge of the applicator approximately 0.5 to 1.5 cm (0.2-0.6 inches) from the wound.Depressandreleasethetreatmenton/obuon(trigger)onthetreatmentwandhandle.Thiswilliniateboththesalineowandultrasounddelivery.Thetreatmentmerwillstarttocountdownonthedisplay.1The UltraMIST System will begin to deliver the ultrasound through a connuousmist.Movethetreatmentwandvercallyacrossthewoundusingmulplepasses.Followthisbymovingthetreatmentwandhorizontallyacrossthewoundusingmulplepasses.Thetreatmentwandshould be moved across the wound using slow, even strokes.Audible (gurgling) and surface visual bubbling may occur. This is normal when moving back and forth through the recommended treatment range. For best results, the treatment wand should be perpendicular to the wound andparalleltotheoorduringtreatment.Note: It is important to maintain a 0.5 to 1.5 cm (0.2 – 0.6 inch) distance from the leading edge of the applicator to the treatment area at all mes to maximize therapeuc eect. 3Connuetreatmentunl3audibletonessoundindicangtheendoftreatmentme.Theultrasoundandsalinewillautomacallystop,ensuringaccuratetreatmentmeforthewoundsizeselected.If there is more than one wound to treat, the next wound screen will appear.Pressthetreatmenton/obuontostarttreangthenextwound.Note: if at anyme during the treatment it is determined addional me will be required, use the up/down buons to add me in increments of 1 minute. Press  to connue. 5Note: You may pause treatment by depressing and releasing the treatment on/o buon. The treatment mer will be paused unl restarted. 0.5 - 1.5 cm13:00Wound 2Acve3:00Treating the Patient continued on next page PL-61044_B 5240.5 - 1.5 cmULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
ULTRAMISTTM SYSTEM SHUTDOWN PROCEDURETurnpowerswitchtoo.Clampthetubingwiththepinchclamp. There may be saline remaining in the bag which is normal depending upon the size of the wound being treated.1Remove the tubing from the treatment wand channel and pump, remove the applicator from the treatment wand andsalinebagfromadjustablehookanddiscard.Followfacility approved biohazard disposal procedures.Usethefacility’sapprovedinfeconcontrolprocedurestoclean the system. 2USB PORTThe generator USB port is designed for the following:• DownloadencryptedperformancedatatoaCelleraonapprovedUSBdrivefortroubleshoongpurposes• UploadsowareupgradesfromaCelleraonprovidedUSBdriveSpecicinstruconsforuseoftheportwillbeprovidedwhenrequired.Note: System does not collect and/or store paent specic data. All data is encrypted to prevent usage by unauthorized personnel. WARNING: DO NOT ATTACH ANY UNAPPROVED USB DRIVES, CABLES, OR EQUIPMENT TO THE DRIVE AS IT MAY INTERFERE WITH OPERATION OF THE DEVICE.Accessing USB Port• Remove Treatment Wand from Generator cradle and set aside• Turn Generator over• Usingacoinoratheadscrewdriver,rotatethelockcounterclockwiseaquarterturntounlockandremovethe cover• Toreplacethecover,posionitovertheport,thenusingacoinoratheadscrewdriver,rotatethelockclockwise a quarter to lock the door in placeTREATING THE PATIENT WITH THE ULTRAMIST™ SYSTEMOnce all the wounds are completed, the summary screen will be displayed.2 Wounds110-139 cm217:002 Completed -- Result-- Total SizeTotal Time --Wound Count --NOTE: To cancel a treatment at any me press the back buon. The “cancel treatment” screen will appear. Use the up down buons to select “yes” or “no” then press select. If you cancel treatment, the treatment summary screen will appear. 23:00CancelTreatment?12PL-61044_B 66ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
COMMON ERRORS (noted on display screen)#ERROR CAUSE SOLUTIONS008 OVERHEAT Treatment wand temperature has exceeded the allowed limitthe system 20 minutes is the expected maximum treatment to count down the minutes required to cool the system. Once this completes, the “paused treatment” screen will appear and the treatment can now be completed.DO NOT TURN OFF SYSTEM during cool down (this will require a replacement of the applicator)200 INVALID REPLACE APPLICATORApplicator has been previously used and should be replacedReplace applicator201 REPOSITIONAPPLICATORtreatment wandAdjust current applicator properly on treatment wand202 MAX USEREPLACE APPLICATORApplicator has been used for the 203 NOT READING APPLICATORApplicator is not being sensed by treatment wandProperly align the applicator on the treatment wandINDICATOR LIGHT (located on front of generator)RED AGREEN PL-61044_B 7ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PROBLEM CAUSES SOLUTIONSSYSTEM WILL NOT TURN ON System not plugged in and/or power cord not properly seated in the generator outlet on back of instrumentEnsure power cord is plugged in and properly  and the other end to the power outletPower is not being delivered to outlet onFuse is missing or blown on system NO POWER TO TREATMENT WAND System is not turned on Toggle power switch located on back of system Treatment wand is not connected to the generatorInsert or re-insert treatment wand cable into connector or generatorSINGLE KEY ON KEYPAD NOT FUNCTIONINGMechanical failure ALL KEYS ON KEYPAD NOT FUNCTIONING Customer ServiceOVERHEAT Treatment wand temperature has exceeded the allowed limit20 minutes is the expected maximum treatment to count down the minutes required to cool the system. Once this completes, the “paused treatment” screen will appear and the treatment can now be completed.DO NOT TURN OFF SYSTEM during cool down(this will require a replacement of the applicator)ERROR MESSAGE ON DISPLAY SCREENAn error has occurred Refer to the common errors table to determine the contents of the error message and call TROUBLESHOOTINGTroubleshooting continued on next pagePL-61044_B 8ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PROBLEM CAUSES SOLUTIONSNO SALINE OR INSUFFICIENT SALINE IS COMING OUT OF APPLICATORWound ready screen is not visible on display screenscreen is seen on displayfor treatment to beginEnsure system power is on and press treatment Saline pump door is open Close pump doorTubing is not properly loaded in the saline pumpLoad tubing into saline pump using tubing guides and close pump doorTubing is clamped  Unkink or remove knot from tubingaligned in center of applicatorapplicator opening and fully seated on the applicator housingTubing spike not fully mated with saline bagEnsure spike and saline bag are fully matedSALINE LEAKING AROUND APPLICATORaligned in center of applicatorapplicator openingtreatment caused saline to accumulate inside applicatorDAMAGED APPLICATOR Damaged in shipment Replace with new applicatorOPEN OR DAMAGED STERILE APPLICATOR PACKAGEDamaged in shipment Replace with new applicatorTROUBLESHOOTINGPL-61044_B 9ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.Risk of electric shock - Do not remove cover or loosen cable connections. Refer servicing to qualified service personnel.Do not use if treatment wand or cables show evidence of deterioration or damage. Discard disposable applicator components appropriately.Risk of burns - Do not touch the metal tip of the treatment wand during operation - Never depress treatment on/off button without applicator in place.Always have the applicator properly seated and tubing clamp open when activating the treatment on/off button.Treatment effectiveness may be diminished if any of the following occur:The applicator is not fully engaged, aligned and securely attached to the treatment wand.The distance between the leading edge of the applicator and the wound is greater than 1.5 cm (0.6 inches).The treatment wand is not held perpendicular to the wound.WARNINGS PRECAUTIONSFor technical questions about the operation of the UltraMIST System contact Celleration Customer Service:PHONE: 1-866-307-MIST (6478)ADDRESS: 6321 Bury Drive, Suite 15, Eden Prairie, MN 55346WEBSITE: www.Celleration.comEMAIL: customerservice@celleration.com TECHNICAL SERVICEULTRAMIST™ PRODUCT SPECIFICATIONSSAFETY REQUIREMENTS ETL listed as ‘Conforms to UL 60601-1’ELECTRONIC COMPATIBILITYSYSTEM CLASSIFICATIONMeets the requirements of IEC 60601-1-2 and FCC Part 18Class II equipmentType BF applied partsSTERILIZATION METHODIPX RATINGGenerator: IP21Treatment Wand: IP22INPUTDETACHABLE POWER CORDCURRENTFUSE100-240 VAC; 50-60Hz125V, 10A UL or equivalent listed for hospital grade. Note: this Class II equipment 2.0AT2AL250VOPERATING AND STORAGE CONDITIONSº to 25º CAtmospheric Pressure: 700 to 1060 mmHg Applicator/System Transport and Storage: Temperature: -25º to 75º CRelative Humidity: 30% to 75% (non-condensing)ACOUSTIC OUTPUT POWER Operating Frequency: 40 Khz ± 1 KhzMaximum Unintentional Ultrasound Energy: < 100mW/cm2Tip Displacement Range: 65µm ± 10µmPL-61044_B 10ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
PL-61044_B 11CONTROL LOCATION FUNCTION Back panel of generator Controls power to the systemKeypad Treatment control panel Allows full set up of treatment parametersTreatment ON/OFF  Front treatment wand handle Note: No parts of the UltraMIST System are serviceable during use or by user.EXPLANATION OF SYMBOLSFREQUENTLY USED FUNCTIONS OF THIS SYSTEMFragile, Handle with CareThis End UpKeep DryRecyclein the European CommunityCE MarkTemperature Limitfor UseManufacturerDate of ManufactureLot NumberDeviceDo Not ReuseUse-By DateETL SymbolClass II EquipmentType BF Applied PartSerial NumberCatalog NumberUpDownBackSelectDo Not Dispose in Municipal WasteOpen ClosedAccompanying DocumentsDo Not Allow Fingers to Contact Moving Parts Do Not ResterilizeULTRAMIST™ SYSTEM INSTRUCTIONS FOR USEOperation of the UltraMIST System is limited to the following:
PL-61044_B 12of the UltraMIST Therapy System should assure that it is used in such an environment.Emissions Test Compliance RF emissionsCISPR 11Group 1 TheUltraMISTSystemusesRFenergyonlyforitsinternalfuncon.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissionsCISPR 11Class A The UltraMIST System is suitable for use in all establishments other thandomesc,andmaybeusedindomescestablishmentsandthosedirectly connected to the public low-voltage power supply network that suppliesbuildingsusedfordomescpurposes,providedthefollowingwarning is heeded:Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interferenceormaydisrupttheoperaonofnearbyequipment.Itmaybenecessarytotakemigaonmeasures,suchasre-orienngorrelocangtheUltraMISTSystemorshieldingthelocaon.Harmonic emissionsIEC 61000-3-2Class AVoltageuctuaons/ickeremissionsIEC 61000-3-3CompliesRef. IEC 60601-1-2:2007 §5.2.1.1Emissions Test Compliance MaximumAcouscOutputPowerComplies TheUltraMISTSystemrequirementfortheMaximumAcouscOutputPower is that the measured value be less than 3W/cm2, which is a requirementestablishedbytheWorldHealthOrganizaonforacouscsafety.Theactualoutputissignicantlylessthantheabovelimit,whichis considered to be safe. SidewallRadiaon Complies TheUltraMISTSystemrequirementforSidewallRadiaonisthatthemeasured value be less than 100mW/cm2, which is a requirement establishedbytheWorldHealthOrganizaonforacouscsafety.Theactualoutputissignicantlylessthantheabovelimit,whichisconsidered to be safe.Ref. TR-75143 on le at CelleraonULTRAMIST™ SYSTEM INSTRUCTIONS FOR USE
ULTRAMIST™ SYSTEM INSTRUCTIONS FOR USEPL-61044_B 13Reference PC-50186 for printing requirements.6321 Bury Drive Suite 15Eden Prairie, MN 55346phone: 952.224.8700fax: 952.224.8750customer service: 866.307.MIST (6478)email:info@celleraon.comweb:www.celleraon.compatentinformaon:www.Celleration.com/company/IPThe UltraMIST System has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful inference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorientorrelocatethereceivingantenna.• Increasetheseparationbetweentheequipmentandreceivers.• Connecttheequipmentintoandoutletonadifferentcircuitdifferentfromthattowhichthereceiverisconnected.• Consultthedealeroranexperiencedradio.TVtechnicianforhelp.

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