Quantum™ Wound Treatment System User`s Manual
Contents
1. Wound Care Anywhere ham WOUND CARE ANYWHERE Quantum Wound Treatment System User s Manual Innovative Therapies Wound Care Anywhere CAUTION This Quantum Wound Treatment System User s Manualis not a guarantee or warranty It is intended only as an operational guide For additional information and questions please contact Innovative Therapies Inc s ITI Customer Service department at 1 866 484 6798 In order for the Quantum Wound Treatment System to provide safe reliable and proper performance the following condi tions must be met Failure to comply with these conditions will void all pertinent warranties There are no user serviceable components in the Quantum All assembly operation adjustment modification main tenance and or repair must be carried out only by qualified personnel authorized by ITI The electrical installation of the room in which the device will be used complies with the appropriate national electri cal standards The product must be used in accordance with this manual and all associated labeling and the Instructions for Use Any device that does not function as expected must be returned to ITI Notice to Users CAUTION Federal law restricts this device to sale by or on the order of a physician As with any prescrip tion medical device failure to follow product instructions or changing settings and performing therapy applications with out the express direction and2. accompanied e Utilizing an approved ITI A C Adapter connect LOW BATTERY by an intermittent three tone audible beep unit to an A C power source to provide operat The unit will continue to alarm until connected ing power and to recharge the internal battery to an A C power source e When the charge falls below a critical level the therapy will be discontinued NOTE Pressing the ON MUTE button after an alarm will silence the beeper for 5 minutes NOTE In the event of an emergency please contact your treating physician caregiver or your local emergency responders NOTE If an Alarm Condition persists and cannot be resolved please contact ITI for further assistance Quantum System User s Manual Rev C 1 12 22 16 Wound Care Anywhere Therapy Selection Lock Unlock The Quantum Wound Treatment System is equipped with a therapy locking feature designed to prevent unauthorized individuals from changing the therapeutic settings inadvertently Locking To lock the unit press and hold the power ON button for three seconds until three audible beeps are heard At this point the unit is locked The therapeutic setting will be recalled each time the unit is powered OFF and ON and the unit will remain locked until it is subsequently unlocked Unlocking To unlock the unit press and hold the power ON button until three audible beeps are heard At this point the unit is unlocked and therapy settings can be changed Additiona
3. Environmental Conditions Storage Conditions TEMP Crate RAM SC ssesccasezsvess eei tree ere Suae nee EXER EE Venen PRENNE Y NEN FA CERES ERR Tee rne EYE FEY ei 100F 120C to 1100F 430C Relative Humidity RANGE 5 5 1 coeant oen reunion ena ae neo age sano Yoann ne TEE 20 9596 Non condensing Atmospheric Pressure Rahge uic oco ens reote te sevi c es tree eer aea e o ek Y resa br G UG o es aee e Vin eoo SKENA eee eae VETE EROSOEN eaae eue 50 kPa to 110 kPa Operating Conditions Temperature R llge cerei nore HE eee EE rera ERE Fen Y PE PEERS FEX RELY sees E EREE EEES 400F 40C to 900F 320C Relative Humidity Range 1 eee rabo tree aee end L esL Lee kae wwii aiid 20 7596 Non condensing Atmospheric Pressure Range esi ve oa c eie ero ee ctor eie eed rn eo si poo 1 arb cerea resi aod sars ESES Poe a ERE REEF E Noe FER ERREE RE E pee 50 kPa to 110 kPa Service life of Quantum Wound Treatment SySteM sssssccccccccsssssssneccecceesssssssceceeeeesssssssseeceeeeeesssssaseeeeeesesseees 3 years CAUTION Federal law restricts this device to sale by or on the order of a physician Quantum System User s Manual Rev C 1 12 22 18 Explanation of Symbols ees amp e amp 86e 090 Refer ti User Instructions Pera r OM I Ii TE Power OFF IPXO Adjssimena Burton 7 sadi Adamen Buthan DM Cnnbriuous liber mi thant AC Pour Status LOT Battery Charge Status BEF LSN Deica Timeout Law Pressure l
4. connector on just enough to secure and seal it Also make sure that the clamp on the SpeedConnect Tube is open see Figure 5 Clamp Power ON I MUTE Power OFF O Continuous Intermittent Button Figure Quantum System User s Manual Rev C 1 12 22 9 Wound Care Anywhere 4 Plug the device s A C Adapter into a suitable 100 240 VAC 50 60Hz outlet Insert the power plug into the Power Jack on the side of the device refer to Figure 5 The Quantum Device should only be used with the supplied A C Adapter Use of an incorrectly rated adapter could create a shock hazard for the patient and caregiver NOTE ITI offers a 12 Volt vehicle adapter that allows the device to operate on external power while traveling 5 Verify the dressing application is correct the tubing is connected and the ITI Suction Tubing with SpeedConnect clamp is open 6 Begin therapy see OPERATING INSTRUCTIONS Canister Removal 1 Press the OFF button to turn the therapy off 2 Close suction tubing clamp 3 Remove tubing connector from top of canister 4 Press canister release button and withdraw canister from bottom of unit 5 Dispose of canister according to local state and federal regulations as well as institutional protocols Dressing Removal Carefully read the SAFETY TIPS in the INTRODUCTION section of this guide prior to removing the dressing NOTE Wounds must be carefully monitored at regular intervals In a non inf
5. an prescribe the proper settings and protocols for the therapy unit Failure to follow product instructions or adjusting settings and performing therapy application without the express direction and or supervision of your trained caregiver may lead to improper product performance and the potential for serious or fatal injury Negative Pressure Level Adjustment There are five negative pressure settings that can be selected 50 mmHg 75 mmHg 100 mmHg 125 mmHg and 150 mmHg The pressure selection buttons are located on the left side of the control panel The button decreases the negative pressure setting and the f button increases the negative pressure setting 1 When the unit is powered up the current setting is selected automatically unless therapy setting has been locked previously by caregiver see Therapy Selection Lock Unlock Section 2 To change the setting simply press either the fa therapy selection button or iw therapy selection button until desired therapy selection is indicated by the green LED 3 The green LED indicator will flash indicating the selection has been made and will continue flashing until the desired negative pressure level has been achieved at which time the LED will remain illuminated If the green LED indicator begins to flash during therapy it means the device is unable to maintain the therapeutic setting This event would most likely be associated with a dressing leak and will require clinician interven
6. at drape material down around the wound site and over the ITI foam dressing to ensure dressing is properly sealed 10 Cut a 1 cm diameter hole in the top of the drape at a convenient location over the dressing see Figure 1 11 Peel the backing from one of the SpeedConnect flanges and place it above the hole made in Step 10 Using the tips of the fingers press around the top of the SpeedConnect to ensure a good seal to the dressing see Figure 2 To Fluid Collection Canister ITI Foam Dressing Polyurethane Drape Figure 1 Figure 2 Canister Installation 1 Ensure that an ITI Canister is properly inserted in the receptacle located on the back side of the therapy unit see Figure 3 The canister should snap into place and lock The canister release button may need to be depressed to permit canister insertion NOTE Always use a new canister with a new patient Quantum System User s Manual Rev C 1 12 22 8 Wound Care Anywhere Quantum Quantum Wound e e Canister Release P Treatment Button SpeedConnect Power Jack Tube Connector ITI Canister 300 cc ITI Canister Figure 3 Figure 4 2 Inspect the SpeedConnect Tube flanges to ensure that they are properly connected to the ITI Dressing and that the connections are well sealed 3 Connect the distal end of the SpeedConnect Tube with the blue tapered connector to the patient port of the Canister see Figure 4 Gently twist and push the
7. attery longevity significantly Average Time for Recharging To ensure the battery has been fully charged the device should be connected to an A C supply for approximately 3 hours After approximately 2 hours of charging the device will have achieved 8096 of total battery capacity Low Battery Alarm While running on battery a low battery alarm will activate when remaining capacity of the battery is less than 2096 See Alarm Operation Typically the unit will continue to operate between 30 minutes and 1 hour after the low battery alarm is activated Low Battery Shutoff If the battery charge falls below a critical level the device will shutoff automatically and therapy will be discontinued At this point the device must be plugged into an A C power source for therapy to resume Once the A C Adapter is plugged in pressing the ON button will restart the device Recharging the Battery Plug the power cord from the A C Adapter into the power receptacle on the side of the therapy unit Plug the A C Adapter into a suitable 120 VAC 60 Hz wall outlet When the device is connected to an AC power source the green power LED on the front of the device will illuminate indicating AC power is present and the amber charging LED located just below the power LED will illuminate when the battery is charging Once the battery is fully charged the amber LED will extinguish indicating the charge cycle is complete When the Quantu
8. e sympathetic nervous system discontinue the use of the Quantum Wound Treatment System to help minimize sensory stimulation Quantum System User s Manual Rev C 1 12 22 2 Wound Care Anywhere BODY CAVITY WOUNDS Underlying structures must be covered by natural tissues or synthetic materials that form a complete barrier between the underlying structures and the ITI Dressing ITI DRESSING USE The ITI Dressings distributed by Innovative Therapies Inc are to be used exclusively with the Quantum Wound Treatment System NOTE All dressing components of the Quantum Wound Treatment System are packaged sterile The decision to use clean versus sterile aseptic technique is dependent upon wound pathophysiology and physician clinician preference All components of the Quantum Wound Treatment System disposable set are latex free Be sure to comply with all other CONTRAINDICATIONS and PRECAUTIONS for the Quantum Wound Treatment System Signs of possible infection may include fever tenderness redness swelling itching and rash increased warmth in the wound area purulent discharge or a strong odor Nausea vomiting diarrhea headache dizziness fainting sore throat with swelling of the mucous membrane disorientation high fever 102 F 38 8 C refractory hypotension orthostatic hypotension or erythroderma a sunburn like rash may be added signs of more serious complications of infection WARNING Do not pack the ITI foam dressings i
9. ected wound dressings should be changed every 48 to 72 hours but no less than 3 times per week with the frequency of dressing change determined by the clinician Infected wounds must be monitored continuously For infected wounds dressings may need to be changed more often than 48 72 hours the dressing change interval should be based on a clinical evaluation of the wound condition rather than a fixed schedule NOTE The canister should be replaced when full the Full Canister alarm activates or at least once every week to minimize the potential for contamination and production of odors 1 Press the OFF button to turn the therapy off 2 Close suction tubing clamp 3 Disconnect SpeedConnect suction tube Twisting the tapered connector will make removing the Suction tube from the canister easier 4 Slowly pull drape up and away from skin while gently stretching drape NOTE If the ITI foam dressing adheres to the wound during removal refer to the SAFETY TIPS section of this manual 5 Discard disposables in accordance with applicable rules regulations and infection control protocols and always follow Universal Safety Precautions Quantum System User s Manual Rev C 1 12 22 10 Wound Care Anywhere Disposal of Dressings Canister and Other Disposables To minimize the risk of infection and contact with contaminated blood or bodily fluids during the dressing changes or disposal it is important to protect all exposed skin and m
10. esk Canister Full auc BBF Low Bathary 7 m NP Claris il internal Powered Equipment Quantum System User s Manual Rev C 1 12 22 Wound Care Anywhere Type amp Apples Part Altom ating Current STERILE EO I Ce Mat probecbed against harrriul effects of water Manofaclurer Date of Manufacture Expiry Date EC REF Lor Batch Number Catalog Number Serial Number Storage Conditions Fragile Method of Sberikzation Ethylene Cleides Dx Geib Tonlama with the Medical Device Derecttea 13 42 EEC ari Pan been subject to fhe conformity procedures Laid chown in the ourc directive Autre Representative in the European Union 19 Wound Care Anywhere 6 Replacement Parts Description Part Number Therapy Unit Quantum Wound Treatment System eeessssssnccccceessssssnsecccceeeessssssaneceeeeeesssssasececeesesssesaneeeeeeeessessaaeeeeeeeess 6702232 Quantum User s Man al cr irr rte re aSa ESSENER coos EXE EEEREYRE EE RS EKIS KESER EE LE FEE CETE ERONEN 6702232M Power Supply AC Power Adapter ioci ror ine sette ha haod ederet Eee Rare Oeo X FEY S a ERE QE E FRE eddy E Pe STER HE ewe ba RR so eU ewe esed ARP ed O rures 47 9100 E EET CI D AQ 47 9150 Accessories IV uNng M 47 5600 NCC sicvvicd ceebcccakedevsaduwosccidsiavvcancdeascxededevendteneiicl
11. essings and Canister ecce i1 Deyice Renewal M EREE 11 4 Operating INStrUCt ONS 5 esieecetcaninecdeusereedeaveivacioixecaadieereanmoomw 12 Power ON OFF ssssscscsessssssssssisezcssscisesessssserssssedsssssasdoesssssssesisisi tS 12 Power Up Procell esscass lt scccdeceaiacisashdactdedacecsssechsesvestatechetaiasasssaiees 13 Therapy Setting Adjustment sssssesssssssessesssssssssssssssssssseeeeeeeeeess 14 Beeper Volume Adjustment ssseseessssseeeeessssseeceessssseceeessseeeeeeess 15 Battery OperatiOn asia nece eo eue tesi Susp IpER UR eeu uine eai EEEE ESE Ee 5 Alani Operatii ecco Roda niae ea mondi bs VR SR Uii NE 16 Therapy Selection Lock Uhlock s os eerte ern re Ya a ey ere ER Po PESE aae 17 E SDSCITICOLIDEIS Sos coes eeiam Ur ERI FEY HIA YERIA ONUS serai IAE Y NT Cpe CE PAM YER ER 18 cnjus P Q 19 6 Replacement Parts oo kia oae n REIR EN EN EN eseese AN PN EN VERRE EXE ENG ME 20 Wound Care Anywhere 1 Introduction Indications The Quantum Wound Treatment System is indicated for the application of suction negative pressure to wounds to pro mote wound healing and for the removal of fluids including wound exudates irrigation fluids body fluids and infectious materials Contraindications The Quantum Wound Treatment System is contraindicated for patients with malignancy in the wound untreated osteomy elitis non enteric and unexplored fist
12. inciveaceisecacehadenesscvessesdsdsvseacetatecseds s Veadlead ackansisaevcrevicestees 47 9600 NOTE Part numbers for Canisters Dressings and Disposable Accessories may be obtained by visiting ITI s website www ITIMEDICAL com NOTE In order to assure the highest safety quality and efficacy of the products the Quantum Wound Treatment System should only be used with Innovative Therapies Inc s disposables and ITI Dressings should only be used with the Quantum Wound Treatment System Quantum System User s Manual Rev C 1 12 22 20 7 Questions amp Information For additional information pertaining to the Quantum Wound Treatment System please contact your local ITI representa tive or Call our customer support professionals at 1 866 484 6798 3770 Park Central Boulevard North Pompano Beach Florida 33064 www itimedical com customerservice itimedical com For questions or comments regarding the content of this User s Manual please contact Innovative Therapies Inc ITI at the above address Please contact ITI Customer Service at 1 866 484 6798 for issues concerning the product and its use Duoderm is a trademark of Convatec The Quantum system and certain components may be subject to one or more of the following patents 7 532 953 7 608 066 8 066 243 other patents pending All Rights Reserved Worldwide P N 6702232M Rev C 1 12 Svedman and SVED are registered trademarks of Innovative Therapies Inc Innovative The
13. ld create a shock hazard for the patient or caregiver WARNING Avoid spilling liquid on any part of the therapy unit Liquids can cause corrosion when left on electronic controls which can lead to failure Component failure may cause the therapy unit to operate erratically possibly causing a potential hazard to the patient or Caregiver WARNING Particular care must be taken when handling undiluted germicide concentrate or chlorine bleach including proper shielding of eyes Always mix by adding concentrated germicide or chlorine bleach to the water NEVER intermix germicides or mix germicides with chlorine bleach Quantum System User s Manual Rev C 1 12 22 6 Wound Care Anywhere 3 Patient Care It is recommended that all sections of this manual be reviewed prior to using the product Carefully read the INDICATIONS CONTRAINDICATIONS PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to perform patient care for a patient with the Quantum Wound Treatment System Applying the Dressing 1 Cleanse wound according to institutional protocols or physician order 2 Debride all necrotic tissue including eschar and hardened slough 3 Becertain the wound has achieved hemostasis 4 Visually examine and palpate wound bed to locate any blood vessels or delicate underlying structure in close proximity 5 Prepare area around wound to permit adhesion of the polyurethane drape NOTE If peri wound area is excessively m
14. lly when the unit is powered OFF and ON the unit will remain unlocked Quantum System User s Manual Rev C 1 12 22 17 Wound Care Anywhere 5 Specifications Quantum Wound Treatment System Dimensio S ssns M 6 x 4 3 x 2 75 in 19 3 x 11 0 x 7 0 cm Vu 0 9 Lbs 0 43Kg Therapy Settings eoe rice ete re eese Ex xen ES poe ese ern an eaa po eas EEEE SaF ETENEE 50 75 100 125 150 mmHg Canister VOLUME Y 300cc 500cc With respect to electric shock fire and mechanical hazards conforms to UL 60601 IEC60601 1 EN60601 1 IEC Classification e Medical Equipment e Equipment not suitable for use in presence of flammable anesthetic mixture with air oxygen or nitrous oxide e Continuous Operation e Type B Applied Part e Class II Internally Powered Equipment e PXO Battery Duration Fully Charged s ssx cccssssesssassesscuacussseesseasesccens onceeeasceesecnsseaeesaascedsensossaebescehacns eas sdaesccaceassrcaceaease up to 24 hours Electrical External Power Supply Input eere 100 240 VAC 50 60Hz 200 mA or 12 24 VDC 850 mA Optional External Power Supply OUtDUL usuoo iro oe eoe eoo o ro eo reo o vt i ai a e eoo seo sans aee eer ea eoe iaa e Ta e ao sees Sv ae ares s eed 5 VDC 1Amps Patient amp Enclosure leakage CUltentu s ooi oet sassessseasinessaasscvessesvasbisas sevesegsiavebags Pene Eee eov ETSE Era 100 Micro amps
15. m Wound Treatment System is disconnected from the AC power source the device will automatically switch over to the internal battery and continue to operate without interruption Quantum System User s Manual Rev C 1 12 22 15 Wound Care Anywhere Alarm Operation Clearing an Alarm Condition To clear an alarm condition turn the therapy unit OFF then ON The alarm will clear when the power is cycled Alarm Troubleshooting FLASHING 0 e Device is ready to be checked and serviced e Return device to representative for service THERAPY TIME OUT FLASHING 1 e LED display flashes 1 accompanied by e Pat around drape to check for leaks If leak LOW PRESSURE an intermittent single tone audible beep is found patch with extra drape material DRESSING LEAK e Unit will continue to alarm until the low e Check all tubing connections between the pressure leak condition is corrected or therapy unit and dressing the alarm is cleared e Check to ensure the canister is fully seated and locked Check for cracks in the canister or lid separation FLASHING 2 e LED display flashes 2 accompanied e Turn unit off by pressing the OFF button CANISTER FULL by an intermittent two tone audible beep Remove canister and replace as necessary m a i to alarm until the canister Press the ON button to resume therapy as ues e If conditions persist the problem may be related to the device FLASHING 3 e The LED display flashes 3
16. n the IV pole it should be clamped no higher than two times the width of the pole base The clamp should be tightened to ensure that the therapy unit cannot slide down the pole 3 Press the ON button AILLED indicators will sequentially illuminate during the power on self test 4 Each time the device is turned on the front panel LED display will indicate the remaining therapy life of the unit using the following display format d XX h YY For example if the display for a 30 day device indicates d 11h 22 this means 11 days and 22 hours of therapy remain on the device This information can also be interpreted as the device has been used for 18 days and 2 hours This provides the caregiver compliance information 5 Upon turning on the device the dressing should slowly collapse indicating the presence of suction Once dressing integrity is verified adjust the unit for desired therapy NOTE The device must be connected to the A C Adapter while attempting to obtain an initial dressing seal 6 Carefully check dressing for vacuum leaks and repair with additional ITI Polyurethane Drape if necessary 7 The Quantum Wound Treatment System should be operated at least 22 hours out of every 24 hour period Remove the ITI Dressing if therapy is terminated or is off for more than 2 hours in a 24 hour period Quantum System User s Manual Rev C 1 12 22 13 Wound Care Anywhere Therapy Setting Adjustment CAUTION Only a physician c
17. nt Systems for more information on use with HBO therapy e Large Canisters Use of Large Canisters 500ml may increase serious risks associated with excessive fluid loss Monitor patient status continually DO NOT USE for infants or other patients with low fluid volume nor for patients at high risk of major hemorrhage During Negative Pressure Therapy the Quantum Suction Pump and ITI Dressing are a closed system and are NOT vented to atmosphere During Therapy when a canister fills with fluid it should be replaced immediately as fluids such as wound exudate will not be removed from the dressing once the canister is full Quantum System User s Manual Rev C 1 12 22 1 Wound Care Anywhere Safety Tips The Quantum Wound Treatment System is indicated for the application of suction negative pressure to wounds to pro mote wound healing and for the removal of fluids including wound exudates irrigation fluids body fluids and infectious materials KEEP THERAPY ON The Quantum Wound Treatment System should be operated at least 22 hours out of every 24 hour period Remove the ITI foam dressing if therapy is terminated or is off for more than 2 hours in a 24 hour period DRESSING CHANGES Clean the wound per physician order prior to dressing application Routine dressing changes should occur every 48 to 72 hours Dressing changes for infected wounds should be accomplished more frequently than 48 to 72 hours Always re place with s
18. nto any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols Quantum System User s Manual Rev C 1 12 22 3 Wound Care Anywhere Features Easy to use One Touch Operation Therapy activation and change of pressure settings can be accomplished with the push of a button Therapy settings can be locked by the caregiver see Therapy Selection Lock Unlock Lighted LEDs clearly indicate current therapeutic settings Renewable Device The Quantum is the world s first renewable NPWT device The therapy unit incorporates a service timer that will indicate when to return the device for renewal Light Weight Impact Resistant The Quantum device weighs only 15 oz 0 43 Kg and can be easily carried and transport ed The polymer enclosure is impact resistant to help prevent damage from dropping Self limiting Pump The pump is designed to mechanically self limit the amount of suction that can be applied to the wound site Electronic sensors limit the maximum applied suction to 200 mmHg 10 Intermittent Mode The Quantum Wound Treatment System can be set to operate intermittently b minute ON 2 minute OFF cycle Unit maintains pressure at 25 mmHg during the OFF state to prevent loss of dressing seal and increase patient comfort NoiseGuard Unit is virtually silent in its normal operation with a well sealed dressing increasing patient comfort and compliance PowerGua
19. oist or oily a medical grade liquid adhesive may improve sealing For fragile skin use a skin sealant prior to drape application or frame the wound with a skin barrier layer such as Duoderm or the ITI SensiSkin Drape Cut the drape to a size large enough to cover the foam and the barrier layer only 6 Take measurements of the wound dimensions and note wound type Select the appropriate foam based on wound assessment Cut the ITI foam dressing to a size that is appropriate for the wound NOTE Do not trim the foam dressing over or around the wound site to help prevent debris from the foamdressing from falling into the wound 7 Place the ITI foam dressing in the wound site taking care to avoid contact with the peri wound skin WARNING Do not packthe ITI foam dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols Loosely fill all visible and invisible dead space in the wound Quantum System User s Manual Rev C 1 12 22 7 Wound Care Anywhere NOTE The ITI foam dressing should cover the entire wound margin including tunneling and undermining However the ITI foam dressing should not be in contact with intact skin 8 Size and trim the ITI Polyurethane Drape to cover dressing plus a 3 5 cm border of intact skin extra pieces of drape can be used to seal dressing leaks Remove the drape s release liner and place over the ITI foam dressing and peri wound 9 P
20. or supervision of a trained clinical caregiver may lead to improper product performance and the potential for serious or fatal injury Wound Care Anywhere Table of Contents Te EPOCH OM NS TT TT 1 PC CAT ONS cesceebesadiaocide ve eee bea ebore peo aeo Qo aei Sos E E EP vvsR cuz Ed iuba dada Edad Reis 1 ContraindicatiOnS 2e ocesdaeese biens edis todo ees E PER EP PeOd Ue Go RM FERE ToU vi oases 1 Precautions o escueses vae hee qiereeduscuc e peeE iE eM debe aos EE e IERE REREN 1 Additional Precautions caccsscsedisasvassatesaancaceddedacadeancrcasedacechadeaeessnendce 1 Safety TIPS sossen anenee iaraa a a aE EEES 2 FBSUIIBS orcsenescsersesoisnenseerded engaia daer ean e ble tO rend a aN eSEE 4 2 Car amp Cleaning sessisesiscssrsresisssssviserssssttesedi st stosstss rs RN T REIS iv tkss i 5 MAO CDG Ms TI TEES 5 Protective Equipment ae cswnsssncxvacavioncsancaccanoawssunceaactinesiaanivenetucteuenseant 5 DIES 01O Sal eese undi eee ve cornu O E E t unde eina ane e 5 Cleaning the Quantum DEVICE uai vere E iesvedenesacemmearsiecenasanipiesawens 6 EEUU Mt Care ossessi E E AES 7 Applying the Dressing ssssesssssssssssssssssssssssesssssssceccececeessssssssssssse 7 Canister Installati n isssiscsisisisisoieisiioss sesis s szinsaseszeseianiserdraiisasidake 8 Canister Removal exiis ov a e a ENEE ENEE TEE EEEa AR RUE EARE EES EEI 10 Dressing Removal ceraccxocssvsesevadondconsiiennsetwandudaandterduserehedsveivarsunieee 10 Disposal of Dr
21. r any sign of contamination and ensure that the device is functioning properly If the device is not operating properly refer to the Alarm Troubleshooting guide in the OPERATING INSTRUCTIONS section of this manual or contact ITI to replace the device To help reduce the risk of infection and contact with contaminated blood and bodily fluids please wear the protective equipment identified above when cleaning the Quantum Wound Treatment device NOTE Always follow Universal Safety Precautions Follow established institution protocols regarding clean versus sterile technique The following cleaning procedure must be performed at least once a week and must be completed between patients The Quantum Wound Treatment device should be wiped with either a diluted solution of 5 milliliters bleach in 1 liter of warm water approximately 1 teaspoon bleach in 1 quart water or mild disinfectant Use a coarse cloth and wring out any excess solution until the cloth is damp and not dripping Refer to the Clinical Guidance for the Innovative Therapies Wound Treatment Systems for more information on acceptable cleaning solutions and products A C ADAPTER INSPECTION The A C Adapter should be inspected regularly for damage and or unusual wear Replace damaged or worn Power Supplies immediately A C Adapters are available from ITI WARNING The Quantum Wound Treatment device should only be used with the supplied A C Adapter Use of an incorrectly rated adapter cou
22. rapies Inc owns uses or has applied for the following trademark s or service mark s Quantum Svedman SVED SensiSkin Speed Connect Outcomes Focused Wound Therapy and Wound Care Anywhere All other trademarks are trademarks of their respective owners or holders 2013 Innovative Therapies Inc Please refer to the Innovative Therapies product manual for indications contraindications precautions and safety information Always consult a physician and product instructions for use prior to application Caution Federal law restricts these devices to sale by or on the order of a physician Quantum System User s Manual Rev C 1 12 22 KAM 195 2 12 P N 6702232M Rev C t 7 3770 Park Central Boulevard North n n OVa l ve Pompano Beach Florida 33064 Call our customer support www itimedical com Therapies professionals at 1 866 484 6798 customerservice itimedical com
23. rd An internal battery provides up to 24 hours of operation from a single full charge Battery charges while unit is operating with the AC adapter While running on battery a low battery alarm will sound and the front panel LED display will indicate a low battery alarm condition when remaining capacity of the battery is less than 2096 TherapyGuard Automated alarms for leak low pressure full canister and low battery Alarms provide both a visual and audible indication Alarms will self reset once a problem is corrected or can be manually reset by turning the therapy unit OFF and ON Audible alarms can be muted for five minutes by pressing the MUTE button SpeedConnect Eight foot single lumen tubing set with adhesive flanges facilitate connection to dressing Single Patient Use Canisters 300cc and 500cc canisters for normal and highly exudating wounds CAUTION Use of large canisters 500ml may increase serious risks associated with excessive fluid loss Monitor patient status continually DO NOT USE for infants or other patients with low fluid volume nor for patients at high risk of major hemorrhage Quantum System User s Manual Rev C 1 12 22 4 Wound Care Anywhere 2 Care amp Cleaning Introduction The following instructions are the Innovative Therapies Inc ITI recommended cleaning and infection control procedures for the Quantum Wound Treatment System The Caregiver should review this manual in its entirety before attemp
24. terile disposables from unopened packages Follow established institution protocols regarding clean versus sterile technique MONITORING THE WOUND Inspect the dressing frequently to ensure that the foam is collapsed and that therapy is being delivered in a consistent manner Monitor periwound tissue and exudate for signs of infection or other complications Extra care and attention should be given if there are any signs of possible infection or related complications Infection can be serious With or without the Quantum Wound Treatment System infection can lead to many adverse complications including pain discomfort fever gangrene toxic shock septic shock and various other complications With signs of more serious complications of infection discontinue the use of the Quantum Wound Treatment System until the serious infection is diagnosed and properly treated DISCOMFORT ADHERENCE If patient complains of discomfort during dressing change consider pre medication such as use of a non adherent prior to foam placement or irrigation of a topical anesthetic agent such as 196 Lidocaine prior to dressing removal UNSTABLE STRUCTURES Use the lowest pressure setting on the Quantum Wound Treatment System over unstable body structures such as unsta ble chest wall or non intact fascia SPINAL CORD INJURY In the event a patient experiences autonomic hyperreflexia sudden elevation in blood pressure or heart rate in response to stimulation of th
25. the control panel Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to operate and adjust the Quantum Wound Treatment System WARNING The Quantum Wound Treatment System should only be used with the supplied A C Adapter Use of an incor rectly rated adapter could create a shock hazard for the patient or caregiver The part number for the adapters can be found in the REPLACEMENT PARTS section of this manual Power On Off The ON and OFF buttons are located on the front top of the control panel The ON and OFF buttons control the application of power to the therapy unit Quantum Power ON I MUTE Q rowerorr o Therapy Select Therapy Indicators Alarm Condition Display 1 g Continuous Intermittent Button iO ome E 48 E E Power Charging Status Inm Quantum System User s Manual Rev C 1 12 22 12 Wound Care Anywhere Power Up Procedure 1 Verify the dressing application is correct the tubing is connected and the ITI Suction Tubing with SpeedConnect clamp is open 2 Place the therapy unit in an upright position as level with the wound as possible The device can be placed on a table or attached to an IV pole using the IV Pole adapter CAUTION The LV pole clamp should only be used on poles that are in excess of 0 9 2 2 cm diameter and are securely attached to a bed frame or suitable stand To ensure stability of the therapy unit o
26. ting to the use the product Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to perform cleaning procedures on the Quantum Wound Treatment Unit Protective Equipment Universal Safety Precautions should be used to minimize the risk of infection and contact with contaminated blood or bodily fluids during the dressing changes or disposal it is important to protect all exposed skin and mucous membranes The protective equipment includes Disposable gloves latex or latex free Protective eyewear to help prevent splashing of cleaning solutions and or blood or bodily fluids Protective mask to protect the nose and mouth from inadvertent fluid ingress Disposable impervious gown if splashing of blood or bodily fluids is possible Disposal After patient use all disposable components of the system should be treated as contaminated These include e The ITI Foam Dressing components The exudate collection canister Tubing connectors and clamps Dispose of all disposable components in accordance with local state and federal regulations and institution protocols NOTE Cleaning procedures should not be performed when unit is connected to a patient Disconnect the unit from the patient and power source before cleaning or servicing Quantum System User s Manual Rev C 1 12 22 5 Wound Care Anywhere Cleaning the Quantum Device Perform a visual inspection of the device Check fo
27. tion to correct Intermittent Mode ON OFF The Quantum can operate in an intermittent suction mode with a 5 minute ON and 2 minute OFF cycle Press the button to turn the Intermittent Mode on and off During intermittent operation Quantum will provide target therapy pressure during the ON part of the cycle and approximately 25 mmHg during the off part of the cycle By maintaining this lower pressure while the unit is OFF the dressing seal is never compromised This method of applying intermittent pressure also increases patient comfort Quantum System User s Manual Rev C 1 12 22 14 Wound Care Anywhere Beeper Volume Adjustment The volume of the beeper can be adjusted to fit various care settings or patient preferences To adjust the beeper volume press and hold the ON button while simultaneously pressing the button to increase the volume or the button to decrease the volume The LED display will indicate the volume level Battery Operation NOTE The Quantum Wound Treatment System is designed to permit use of the product while the internal battery is charging The therapy unit will continue to operate properly while the battery is charging Battery Life The specified battery life of the Quantum Wound Treatment System with a fully charged battery and a well sealed dress ing is up to 24 hours The actual life is dependent on the integrity of the dressing A leak in the dressing can reduce overall b
28. ucous membranes The protective equipment includes Disposable gloves latex or latex free Protective eyewear to help prevent splashing of cleaning solutions and or blood or bodily fluids Protective mask to protect the nose and mouth from inadvertent fluid ingress Disposable impervious gown if splashing of blood or bodily fluids is possible After patient use all disposable components of the system should be treated as contaminated These include The ITI foam dressing and ITI Polyurethane Drape e The exudate collection canister e SpeedConnect tubing connectors amp clamps Dispose of all disposable components in accordance with local state and federal regulations and institution protocols Device Renewal When the device s service timer indicates it is time to have the therapy unit renewed please return the device and A C power adapter to Innovative Therapies Inc or its representative for servicing Please ensure the canister is removed from the device before sending it and never send disposable components accessories such as the carry bag canisters dressings or tubing in the return package Quantum System User s Manual Rev C 1 12 22 11 Wound Care Anywhere 4 Operating Instructions This section contains instructions for setting and adjusting functions of the Quantum Wound Treatment System The section explains the procedure for activating therapy and explains the major functions that are adjusted from
29. ulas or necrotic tissue with eschar present Do not place the ITI foam dressing over exposed blood vessels or organs Precautions Precautions should be taken for patients with active bleeding difficult wound hemostasis or who are on anticoagu lants When placing the ITI foam dressing in close proximity to blood vessels or organs take care to ensure that they are adequately protected with overlying fascia tissue or other protective barriers Exposed tendon nerves or blood vessels should be protected by moving available muscle or fascia over them or by a layer of synthetic material Greater care should be taken with respect to weakened irradiated or sutured blood vessels or organs Bone fragments or sharp edges could puncture a dressing barrier vessel or organ Wounds with enteric fistula require special precautions in order to optimize therapy Additional Precautions Defibrillation Remove the ITI Dressing if defibrillation is required in the area of dressing placement Failure to remove the dressing may inhibit electrical current transmission and or patient resuscitation Magnetic Resonance Imaging MRI The Quantum Suction Pump Unit is not MRI compatible Do not take into the MRI area Hyperbaric Oxygen Therapy HBO NEVER allow a device whether on or off inside a hyperbaric chamber The device must be disconnected from the patient prior to HBO treatment Refer to the Clinical Guidance for the Innovative Therapies Wound Treatme
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