Cardinal Health™ SVED®
Contents
1. A e A AS i aluat 47 9000 Dressings Cardinal Health NPWT Small Foam Dressing Kit 10 per case ssscsssesssssecsssecsssesssssscsnscersssssszseennscensesesnnseens 47 1702 Cardinal Health NPWT Medium Foam Dressing Kit 10 per CaS ssssssssesssescsseesssseccsnseesssccesseecsnceesnecessecssneeess 47 1701 Cardinal Health NPWT Large Foam Dressing Kit 10 per case sssssssssssesessseccssecesseccsssecsuscessseecsnceesuecesuseessneeess 47 1700 Cardinal Health NPWT X Large Foam Dressing Kit 10 per CaS ssssssssecsseccsseecssseccsnseessscessseecsncessueceseeessneeess 47 1703 Cardinal Health White Foam Dressing 10 per case s sssccsssssssssscnsscsssesssnseesssecssseessnsecsnscenssessszscennscensesssanseens 47 1751 Canisters Cardinal Health Disposable Canister with Gel 300 cc 10 per case sesssssessssssssccsesssessstecsssssssecsucceseessnessseeses 47 4000 Cardinal Health Disposable Canister with Gel 500 cc 10 per case sesssssessesssssecsssssscessecssscessecsuccsseessnessueesse 47 4500 Accessories Cardinal Health SVED I V Pole Bed Hanger Adaptet s ssssssssssscssscsssesssnsscsssecsssesssnssesnscerssessszseennscensesesanseens 47 5500 Cardinal Health SVED Canvas Carry Bag nen 47 9500 Cardinal Health SpeedConnect Tubing ssssssssssssesssssssesesrssssssessereessssssneeteressssseeeetersesnsseenereessssseeeereressseseeee 47 2000 Cardinal Health NPWT2. Y Connector imam oa i n toc at ip ta 47 2500 Cardinal Health NPWT Polyurethane Drape 10 per pk ssssssecsssssessssssssesssesessusssesessssssnscseseesuecsesesseesescsess 47 7000 Cardinal Health NPWT SensiSkin Drape 10 per pkg nennen iati n a 47 7100 Cardinal Health NPWT Irrigation Tubing with SpeedConnect ssssssscsssescssescsseccsneecssccesseecsnseesuecesstecsseeeese 47 6000 NOTE Part numbers for Canisters Dressings and Disposable Accessories may be obtained by visiting the Cardinal Health website www cardinalhealth com NOTE In order to assure the highest safety quality and efficacy of the products the Cardinal Health SVED device should only be used with Cardinal Health NPWT components and Cardinal Health NPWT components should only be used with the Cardinal Health NPWT Devices 27 a gt A g9 gt Cc 74 MD 9 5 S oi 5 5 N gt c A H U 7 Questions amp Information For additional information pertaining to the Cardinal Health SVED device please contact your local Cardinal Health representative or Call our customer support professionals at 1 866 484 6798 Cardinal Health Waukegan Rd IL 60085 www cardinalhealth com CustomerServiceNPWT cardinalhealth com For questions or comments regarding the content of this User s Manual please contact Cardinal Health at the above address Please contact Cardinal Health
3. clean versus sterile aseptic technique is dependent upon wound pathophysiology and physician clinician preference All components of the Cardinal Health NPWT disposable set are made without natural rubber latex Be sure to comply with all other 1 2 CONTRAINDICATIONS and 1 3 PRECAUTIONS in the 1 INTRODUCTION section for the Cardinal Health SVED User Manual Signs of possible infection may include fever tenderness redness swelling itching and rash increased warmth in the wound area sudden increase in pain purulent discharge or a strong odor Nausea vomiting diarrhea headache dizziness fainting sore throat with swelling of the mucous membrane disorientation high fever gt 102 F 38 8 Q refractory hypotension orthostatic hypotension or periwound induration a sunburn like rash may be added signs of more serious complications of infection WARNING Do not pack the Cardinal Health NPWT Dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols a gt A D 5 Cc 74 d 5 E 3 N c Au U 1 6 Features Easy to use One Touch Operation Therapy can be activated with the push of a single button Therapy level can be quickly changed by pressing one of three buttons 70 mmHg 120 mmHg and 150 mmHg Therapy settings can be locked by the caregiver see 4 9 THERAPY SELECTION LOCK UNLOCK L
4. APPLYING THE DRESSING to ensure complete removal 7 Discard disposables in accordance with applicable rules regulations and infection control protocols and always follow Universal Safety Precautions 3 5 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 mucous membranes The protective equipment includes e 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 e 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 e The Cardinal Health NPWT foam dressing and Cardinal Health Polyurethane Drape The Cardinal Health NPWT canister SpeedConnect tubing connectors amp clamps Dispose of all disposable components in accordance with local state and federal regulations and institution protocols 3 6 Utilizing Wound Irrigation with the Cardinal Health SVED Device optional The Cardinal Health SVED device allows for the optional use of wound irrigation to the wound bed NOTE Wound irrigation should only be used with direct supervision
5. Customer Service at 1 866 484 6798 for issues concerning the product and its use 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 28 Clinician User Manual 29 CardinalHealth wil Cardinal Health 1500 Waukegan Road Waukegan IL 60085 USA 07 15 cardinalhealth com 2015 Cardinal Health All Rights Reserved CARDINAL HEALTH the Cardinal Health LOGO SVED SENSISKIN and SPEEDCONNECT are rademarks or registered trademarks of Cardinal Health US Pat 7 532 953 7 608 066 8 066 243 EC REP EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands 0086
6. Tubing is open Figure 15 MA 4 JE Clamp SpeedConnect Tubing Connector Canister Figure 15 4 Plug the device s A C Adapter into a suitable 100 240 VAC 50 60Hz outlet Insert the power plug into the Power Connector on the side of the device Figure 16 The Cardinal Health SVED 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 e Clamp Battery Charging Port Therapy Timer Display Figure 16 5 Verify the dressing application is correct the tubing is connected and the Cardinal Health SpeedConnect Tubing clamp is open 6 Begin therapy see 4 OPERATING INSTRUCTIONS a gt A ES 5 Cc 74 M g9 5 S oi 3 3 Canister Removal 1 Close suction tubing clamp 2 Press the OFF button to turn the therapy off 3 Disconnect SpeedConnect tubing from top of canister Twisting the tapered connector will make removing the suction tube from the canister easier 4 Press canister release button and withdraw canister from bottom of device 5 Dispose of canister according to local state and federal regulations as well as institutional protocols NOTE The canister should be replaced when full the Canister Full alarm activates or at least once every week to minimize the potential for contamination and production of odors 3 4 Dressing Removal Carefully read the 1 5 SAFETY TI
7. a a ina 20 95 Non condensing Atmospheric Pressure Range nen 50 kPa to 110 kPa Operating Conditions Temperature Range OA E aula ns ia ata 40 F 4 C to 90 F 32 C Relative Humidity Range cocina ac d 20 75 Non condensing Atmospheric Pressure Range sn 50 kPa to 110 kPa Service life of Cardinal Health SVED oran 3 years CAUTION Federal law restricts this device to sale by or on the order of a physician Specifications subject to change without notice 23 a gt A 5 5 Cc u d 5 5 7 u gt inician CI 5 1 Explanation of Symbols 24 Device gt O Dressings i STERILE EO m m 10 F 12 C LOT 110 F 43 C Consult Instructions for Use Class II Internally Powered Equipment Type B Applied Part Consult Instructions for Use Method of Sterilization Ethylene Oxide Expiry Date Date of Manufacture Lot Batch Number Storage Conditions IPXO Alternating Current Not protected against the harmful effects of water Fragile Keep Dry Single Use Only Conforms with the Medical Device Directive 93 42 EEC and has been subject to the conformity proceduress laid down in the council directive 5 2 Electromagnetic Compatibility The Cardinal Health SVED device conforms to all pertinent requirements of IEC 60601 1 2 The EMC summary tables are provided herein below for your reference Guidance and Manufa
8. 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 a gt A D 5 Cc 74 d 5 E 3 ET N c A U e During Negative Pressure Wound Therapy the Cardinal Health SVED device and Cardinal Health NPWT Dressing are a closed system and are NOT vented to atmosphere During Negative Pressure Wound 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 When utilizing optional wound irrigation The Cardinal Health SVED system is intended for use with saline solutions in a physiologic pH range that can optionally include topical wound treatment solutions Various topical agents such as hydrogen peroxide are not intended for extended tissue contact If in doubt about the appropriateness of using a solution with the Cardinal Health SVED system contact the solution s manufacturer Do not apply solutions in conflict with the manufacturer s instructions for use During irrigation therapy the Cardinal Health NPWT Dressing is a closed system and is NOT vented to atmosphere Do not use where temperature of fluid could cause an adverse reaction such as a change in patient s core body temperature During irrigation th
9. clinical caregiver may lead to improper product performance and the potential for serious or fatal injury a gt D 5 Cc 74 d 5 Table of Contents TE EIN sees cases iai ee ac atacat o n at ian ina at 3 1 1 Ii UN OTN ec APR RR SR RES RI RER NR TI E II a CRIS RIN N E ANRE 3 12 Contraindica tions rias 3 13 PGA MIO a cc ta pi ol a a ac i st 3 14 Additional PLE CAUTIONS socata canari em anu ii E dat d A 3 1 5 Safety TIPS is 4 1O Features sa s nea ac piu a on e dl a da ol o nt 6 A An a aiba a a PO ni ma 7 A e O PO ES OOO aap Rae atone 7 2 2 Protective UN aid 7 Dia DD ee O PE E a iad ca apa dia d 7 2 4 Daily Care and Cleaning ne 7 2 5 Between Patient and Weekly Care and Cleaning s ssssssssscsssesssssssssssssssssessusssasessssssnscsssecsuessasessussensessseessecs 8 3 Patient Cie een 9 SLAM aaa aaa 9 5 3 2 Lanlelerinstalalan rss 12 E e Canister Removal asn PU uo RTR ARI O PORN A DN NR 14 3A Dressing A ata inta iat ad ta ee iii pat di 14 g 3 5 Disposal of Dressings Canisters and Other Disposables ssssssesssssssssssssscsssessscsssessssecsucseseessucesscessscesncesess 15 3 6 Utilizing Wound I Gala daa 15 S 4 Operaling Instruction ses 17 41 Power ON OFF casino la e d t 17 T 4 2 Power Up Procedur oia ele nl ta d bilant 18 4 3 Therapy Setting AUS Min ti ca tit 18 44 Intermittent Mode ON OFF aaa 19 4 3 Therapy MEN DER IN en een 19 4 6 Alarm Volume Level Co
10. components Exudate collection canister e Tubing connectors and clamps and irrigation delivery set if irrigating Dispose of all disposable components in accordance with local state and federal regulations and institution protocols NOTE Cleaning procedures should not be performed when device is connected to a patient Disconnect the device from the patient and power source before cleaning or servicing 2 4 Daily Care and Cleaning Perform a visual inspection of the device Check for any sign of contamination and in particular any fluid ingress and ensure that the device is functioning properly If the device is not operating properly refer to the Alarm Troubleshooting guide in the 4 OPERATING INSTRUCTIONS section of this manual or contact Cardinal Health to replace the device a gt A 5 Cc 74 d 5 E 5 u gt c A 2 U 2 5 Between Patient and Weekly Care and Cleaning 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 Cardinal Health SVED 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 Cardinal Health SVED device should be wiped with either a d
11. disconnected from the AC power source the device will automatically switch over to the internal battery and continue to operate without interruption 20 4 8 Alarm Operation Clearing an Alarm Condition To clear an Alarm Type remedy the condition using the Troubleshooting table below Once the condition is corrected the alarm will automatically reset To manually reset an alarm turn the therapy device OFF then ON The alarm will clear when the power is cycled ALARM TYPE LOW PRESSURE LEAK LOW BATTERY INDICATION CORRECTIVE ACTION e Canister Full LED lights e Clamp the tubing accompanied by an intermittent Turn device off by pressing the OFF E button audible alarm e Remove canister and replace o e Device will continue to alarm Open the clamp and press the ON EN button until the canister is replaced to resume therapy e Low Pressure Leak LED e Clamp the tubing lights accompanied by an e If Low Pressure Leak LED and audible alarm intermittent audible alarm reset there is a leak below the clamp often Device will continue to alarm inthe dressing Reopen the clamp before until the low pressure leak addressing the leak Gently press around condition is corrected or the drape to check for leaks If leak is found patch alarm is cleared with extra drape material If Low Pressure Leak LED and audible alarm continue there is a leak above the clamp Check tubing connection at the canister Check to ensure the canister is
12. fever gangrene toxic shock septic shock and various other complications With signs of more serious complications of infection discontinue use of the Cardinal Health SVED system until the serious infection is diagnosed and properly treated DISCOMFORT ADHERENCE If patient complains of discomfort during dressing change consider pre medication use of a non adherent wound contact layer prior to foam placement or irrigation of a topical anesthetic agent such as 1 Lidocaine prior to dressing removal UNSTABLE STRUCTURES Over unstable body structures such as unstable chest wall or non intact fascia use the lowest pressure setting on the Cardinal Health SVED device SPINAL CORD INJURY In the event a patient experiences autonomic hyper reflexia sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system discontinue use of the Cardinal Health SVED device to help minimize sensory stimulation UNDERLYING STRUCTURES Underlying structures must be covered by natural tissues or synthetic materials that form a complete barrier between the underlying structures and the Cardinal Health NPWT Dressing CARDINAL HEALTH NPWT DRESSING USE The Cardinal Health NPWT Dressings distributed by Cardinal Health are to be used exclusively with the Cardinal Health SVED device NOTE All dressing components of the Cardinal Health NPWT Dressing kit are packaged sterile The decision to use
13. fully seated and locked Check for cracks in the canister or lid separation Iffound replace the canister e Open the clamp The OFF button will flash Utilizing an approved Cardinal Health A C accompanied by an intermittent Adapter connect device to an A C power audible chirp every 10 seconds source to provide operating power and to The device will continue to recharge the internal battery alarm until connected to an A C power source e When the charge falls below a critical level the therapy will be discontinued 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 Cardinal Health for further assistance 21 a gt A 5 5 74 d 5 2 S 5 ET u gt c Au 2 U 4 9 Therapy Selection Lock Unlock The Cardinal Health SVED device is equipped with a therapy locking feature designed to prevent unauthorized individuals from changing the therapeutic settings inadvertently Locking To lock the device press and hold the desired Pressure Setting GB button 70 120 150 mmHg for three 3 seconds until three 3 audible beeps are heard At this point the device is locked Pressing any other therapy level will result in three 3 beeps with no change in setting This therapeutic setting will be recalled each time the device
14. is powered OFF and ON and the device will remain locked until it is subsequently unlocked by the caregiver Unlocking To unlock the device press and hold the selected Pressure Setting button the lit button until three 3 audible beeps are heard At this point the device is unlocked and therapy settings can be changed Additionally when the device is powered OFF and ON the device will remain unlocked and will automatically revert to the default setting of 120 mmHg B 22 5 Specifications Cardinal Health SVED Device E oala tan ai aia ate 7 5 x 2 5 x 6 8 in 19 05 x 6 35 x 17 27 cm ALO y ERROR ORI TREE PP A 2 0 Lbs 910 g o O A een 70 120 amp 150 mmHg E e PR N PRO ES 0 UU 7 UU E A 300cc 500cc Medical Equipment with respect to electric shock fire and mechanical hazards only in accordance with IEC60601 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 Type B Applied Part e Class Il Internally Powered Equipment IPXO Battery A a iai ia up to 18 hours Electrical External Power Supply MUL casta at atac inca iti a tt 100 240 VAC 50 60Hz 700 mA External Power Supply Output rara 15 VDC 2 Amps Patient amp cEnelos relBakage ieh een lt 100 Micro amps Environmental Conditions Storage Conditions Temperature Range een 10 F 12 C to 110 F 43 C A ea acad a aaa nea
15. 000 4 6 3V rms 150 kHz 80 MHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range P Radiated RF IEC 61000 4 3 3V m 800 MHz 2 5 GHz Note1 At 80 MHz and 800 MHz the higher frequency range applies Interference may occur in the vicinity of equipment marked with the following symbol c e Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Cardinal Health SVED device is used exceeds the applicable RF compliance level above the Cardinal Health SVED device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Cardinal Health SVED device P Over the frequency range 150 kHz to 80MHz field strengths should be less than 3 V m 6 Replacement Parts Device Cardinal Health VEDA id 6701132 Power Supply
16. 2 minute OFF cycle To turn the intermittent mode on press and hold the desired Pressure Setting button then momentarily press the OFF button The device will beep twice and the ON O button will begin flashing indicating the device is now operating in intermittent mode Release both buttons To turn the intermittent mode off and return the device to the default continuous mode repeat the above steps The device will produce a single long beep and the ON O button will steadily illuminate The Cardinal Health SVED device will remember the mode setting when the power is turned OFF and ON During intermittent operation the Cardinal Health SVED device will provide target therapy pressure during the ON part of the cycle and approximately 25 mmHg during the OFF part of the cycle This lower pressure setpoint during the OFF cycle maintains the integrity of the seal to prevent leaks 4 5 Therapy Timer Display s w ver 2 63 amp higher The Cardinal Health SVED device has an LED Therapy Timer Display Figure 16 for displaying two types of therapy timers Total Time accumulated by the device non resettable and patient usage Therapy Time resettable The display will use the format d days H hours mins and data will be displayed sequentially on the display When the device is first turned ON the Total Time is displayed This timer cannot be reset and accumulates time as the device is used After the dev
17. 25 cycles lt 5 UT 95 dip in UT for 5 sec Electromagnetic Environment Guidance Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial and or hospital environment Mains power quality should be that of a typical commercial and or hospital environment Mains power quality should be that of a typical commercial and or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Uy is the A C mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity IEC 60601 1 2 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Cardinal Health SVED device including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter Recommend separation distance d 1 2 4P d 1 2 VP 80 MHz to 800 MHz d 2 3 yP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Conducted RF IEC 61
18. Cardinal Health NPWT foam dressing in the wound site taking care to avoid contact with the peri wound skin Figure 3 Figure 1 Figure 2 Figure 3 Ko WARNING Do not pack the Cardinal Health NPWT 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 NOTE The Cardinal Health NPWT foam dressing should cover the entire wound base including tunneling and undermining However the Cardinal Health NPWT foam dressing should not be in contact with intact skin 8 Size and trim the Cardinal Health 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 Figure 4 Figure 4 9 Remove the drape s release liner starting with tab A Figure 5 Invert and place over the Cardinal Health NPWT foam dressing and peri wound Figure 6 and continue removing the contact layer with tabs B and C Figures 7 8 Remove the remaining perforated tab Figure 9 Gently press drape material down around the wound site and over the Cardinal Health NPWT foam dressing to ensure dressing is properly sealed 5 3 ET N gt c Au 2 U Figure 7 Figure 8 Figure 9 10 Cut a 1 cm diameter hole in the top of the drape at a convenient location over the foam dressing by pinching and lifting the drape
19. Cardinal Health SVED Clinician User Manual Cat 6701132 5 a CardinalHealth jenuew 13sN ueniu CAUTION This Cardinal Health SVED CLINICIAN User Manual is not a guarantee or warranty It is intended only as an operational guide For additional information and questions please contact the Cardinal Health Customer Service department at1 866 484 6798 In order for the Cardinal Health SVED to provide safe reliable and proper performance the following conditions must be met Failure to comply with these conditions will void all pertinent warranties There are no user serviceable components in the Cardinal Health SVED device All assembly operation adjustment modification maintenance and or repair must be carried out only by qualified personnel authorized by Cardinal Health The electrical installation of the room in which the device will be used complies with the appropriate national electrical 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 Cardinal Health Notice to Users CAUTION Federal law restricts this device to sale by or on the order of a physician As with any prescription medical device failure to follow product instructions or changing settings and performing therapy applications without the express direction and or supervision of a trained
20. E 3 y un c A 4 U 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 80 of total battery capacity Low Battery Alarm While running on battery a low battery alarm will chirp every 10 seconds and the OFF button will begin flashing when remaining capacity of the battery is less than 20 Typically the device will continue to operate for approximately 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 connector on the side of the device 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 LED below the power connector will illuminate indicating AC power is present and the AMBER 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 Cardinal Health SVED device is
21. Figure 10 11 Peel the backing from the SpeedConnect port and place it over the hole made in Step 10 Figures 11 12 Using the tips of the fingers press around the top of the SpeedConnect to ensure a good seal to the dressing 12 Connect the distal end of the SpeedConnect Tubing with the blue tapered connector to the open port of the Canister Figure 13 Gently twist and push the connector on just enough to secure and seal it y d Figure 10 Figure 11 Figure 12 a gt A ES 5 Cc 74 MD g9 5 S oi Figure 13 3 2 Canister Installation 1 Ensure that a Cardinal Health NPWT Canister is properly inserted in the connector located on the side of the device Figure 14 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 Canister Release E ies i Exudate Collection Canister g Figure 14 Clinician User Manual 2 Inspect the SpeedConnect Tubing port s to ensure that they are properly connected to the Cardinal Health NPWT Dressing and that the connections are well sealed 3 Connect the distal end of the SpeedConnect Tubing with the blue tapered connector to the patient port of the Canister Figure 15 Gently twist and push the connector on just enough to secure and seal it Also make sure that the clamp on the SpeedConnect
22. PS in the 1 INTRODUCTION section of this guide prior to removing the dressing NOTE Wounds must be carefully monitored at regular intervals In a non infected 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 1 With the device ON lift a corner of the drape to allow air to enter the system This will help move any fluid in the SpeedConnect tubing into the canister E 3 a y u gt c A H U 2 Close suction tubing clamp 3 Press the OFF button to turn the therapy off 4 Disconnect SpeedConnect tubing from top of canister Twisting the tapered connector will make removing the suction tube from the canister easier 5 Gently stretch the drape laterally and slowly pull up and away from skin Lateral stretching of the drape will help release the adhesive and minimize trauma to the patient s skin NOTE If the Cardinal Health NPWT foam dressing adheres to the wound during removal refer to the 1 5 SAFETY TIPS section of this manual 6 Remove all dressing materials from the wound Count the foam pieces and compare to prior documentation see Step 6 in 3 1
23. TIONS 1 3 PRECAUTIONS and 1 5 SAFETY TIPS in the 1 INTRODUCTION section before attempting to perform patient care with the Cardinal Health SVED device 3 1 Applying the Dressing 1 Cleanse wound according to institutional protocols or physician order 2 Debride all necrotic tissue including eschar and slough 3 Be certain 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 moist 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 a hydrocolloid the Cardinal Health Drape or Cardinal Health 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 Cardinal Health NPWT foam dressing to a size that is appropriate for the wound Figure 1 Document the number of foam pieces used to fill the wound NOTE Do not trim the foam dressing over or around the wound site to help prevent debris from the foam dressing from falling into the wound Figure 2 a gt ES 5 Cc 74 M g9 5 S oi 7 Place the
24. cturer s Declaration Electromagnetic Emissions IEC 60601 1 2 Harmonic emissions Class A The Cardinal Health SVED device is suitable for use in all establishments IEC 61000 3 2 including medical facilities domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 RF emissions Complies The Cardinal Health SVED device is not suitable for interconnection with CISPR 14 1 other equipment Recommended separation distance between portable and mobile RF communications equipment and the Cardinal Health SVED Device The Cardinal Health SVED device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Cardinal Health SVED device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Cardinal Health SVED device as recommended below according to the maximum output power of the communications equipment Output Power of Separation distance according to frequency of transmitter in meter s For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter
25. erapy the irrigation bag should be checked periodically to ensure proper fluid delivery In addition when a canister fills with fluid it should be replaced immediately as irrigation fluid and wound exudate will not be removed from the dressing once the canister is full 1 5 SAFETY TIPS KEEP THERAPY ON The Cardinal Health SVED device should be operated at least 22 hours out of every 24 hour period Remove the Cardinal Health NPWT 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 72 hours Always replace with sterile 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 wound exudates for signs of active bleeding 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 Cardinal Health SVED system infection can lead to many adverse complications including pain discomfort
26. ice has displayed the Total Time and at any time the device is operating pressing the ON button and 120 mmHg 8 buttons simultaneously will initiate the display of Therapy Time To reset the Therapy Time press and hold the ON button and 120 mmHg 58 button until the device beeps three times and the Therapy Time display indicates d 0 H 00 00 4 6 Alarm Volume Level Control s w ver 2 63 amp higher The volume of the alarm can be adjusted to fit various care settings or patient preferences To adjust the alarm volume press and hold the ON O button while simultaneously pressing the yellow 150 mmHg B button to increase the volume or the 70 mmHg button to decrease the volume The LED display on the side of the device will indicate the volume level which ranges from 1 to 5 The nominal alarm volume level for the device is 2 which is generally sufficient for most care settings 4 7 Battery Operation NOTE The Cardinal Health SVED device is designed to permit use of the product while the internal battery is charging The device will continue to operate properly while charging is taking place Average Battery Life The specified battery life of the Cardinal Health SVED device with a fully charged battery is approximately 18 hours The actual life is dependent on the integrity of the dressing A leak in the dressing can reduce overall battery longevity significantly a gt 5 Cc 74 d 5
27. ighted membrane switches clearly indicate current setting to caregiver Light Weight The therapy device weighs 2 0 lbs 910 g for increased mobility NoiseGuard Device is virtually silent in its normal operation with a well sealed dressing PowerGuard An internal battery provides up to 18 hours of operation from a single full charge Battery charges while device is operating with the AC adapter While running on battery a low battery alarm will chirp and the OFF button will begin flashing when remaining capacity of the battery is less than 20 Intermittent Mode The Cardinal Health SVED device can be set to operate intermittently 5 minute ON 2 minute OFF cycle Device maintains a 25 mmHg vacuum during the OFF state to prevent loss of dressing seal TherapyGuard Automated alarms for leak low pressure and full canister 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 device OFF and ON V Pole Bed Hanger Adapter Pole clamp permits the device to be mounted to a wide range of standard I V poles 0 9 to 2 0 2 2 to 5 0 cm in diameter SpeedConnect Eight foot single lumen tubing set with adhesive port facilitates connection to dressing Single Patient Use Canister 300cc and 500cc canisters with and without gel solidifier for normal and highly exudating wounds CAUTION Use of Large Canisters gt 500ml
28. iluted 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 Other cleaning fluids are not recommended as they may damage the finish of the enclosure 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 Cardinal Health WARNING The Cardinal Health SVED 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 or caregiver and or severely damage the device WARNING Avoid spilling liquid on any part of the device Liquids can cause corrosion when left on electronic controls which can lead to failure Component failure may cause the device 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 3 Patient Care It is recommended that all sections of this manual be reviewed prior to using the product Carefully read the 1 1 INDICATIONS 1 2 CONTRAINDICA
29. imity to the suction SpeedConnect or in larger wounds may be placed over another area of the wound distal to the suction SpeedConnect 7 Turn device ON and allow dressing to reach set pressure 8 Open the clamp and allow irrigation solution to flow until the irrigation solution begins to move through the suction SpeedConnect tubing and into the canister 9 Set the drip rate per physician order Note drip rate does not need to be exact with continuous wound irrigation Note The irrigation rate will remain constant unless the therapy pressure setting is changed or if device is in intermittent mode 4 Operating Instructions This section contains instructions for setting and adjusting functions of the Cardinal Health SVED device The section explains the procedure for activating therapy and explains the major functions that are adjusted from the control panel Carefully read the 1 3 PRECAUTIONS and 1 5 SAFETY TIPS in the 1 INTRODUCTION section before attempting to operate and adjust the Cardinal Health SVED device WARNING The Cardinal Health SVED 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 or caregiver The part number for the adapter can be found in the 6 REPLACEMENT PARTS section of this manual 4 1 Power ON OFF The ON E and OFF buttons are located on the front top of the control panel and control the application of
30. ld be operated at least 22 hours out of every 24 hour period Remove the Cardinal Health NPWT Dressing if therapy is terminated or is off for more than 2 hours in a 24 hour period 4 3 Therapy Setting Adjustment CAUTION Only a physician can prescribe the proper settings and irrigation protocols for the therapy device 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 Adjusting Pressure Setting There are three pressure settings available 70 120 and 150 mmHg 8 B The pressure selector buttons are located on the bottom front of the control panel Use these buttons to select the therapy setting that is appropriate for the patient 1 When the device is powered up the default setting of 120 mmHg 8 is automatically selected unless therapy setting has been locked previously by caregiver see 4 9 THERAPY LOCK UNLOCK 2 To change the Pressure Setting press the desired Pressure Setting button 3 The setting button 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 button will stay illuminated 4 4 Intermittent Mode ON OFF The Cardinal Health SVED device can operate in an intermittent suction mode with a 5 minute ON and
31. 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 hemorrhage 2 Care amp Cleaning 2 1 Introduction The following instructions are the Cardinal Health recommended cleaning and infection control procedures for the Cardinal Health SVED device The Caregiver should review this manual in its entirety before attempting to use the product Carefully read the 1 3 PRECAUTIONS and 1 5 SAFETY TIPS in the 1 INTRODUCTION section before attempting to perform cleaning procedures on the Cardinal Health SVED device 2 2 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 and cleaning of the device 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 e Disposable impervious gown if splashing of blood or bodily fluids is possible 2 3 Disposal After patient use all disposable components of the system should be treated as contaminated These include The Cardinal Health NPWT Foam Dressing
32. ntrol nennen 19 41 Battery ONEA LIU sine a R RNa 19 4 g Alarm ODER o o E RR OR TERREI RA TENOR any neon nt e naa DT RI NE SRR 21 4 9 Therapy Selection Lo Ud nn 22 RO 23 A A E ata A ai 24 5 2 Electromagnetic Compatibility nn 25 6 Replacement Parts rai n 27 7 Questions Inlormalion scie ca i alcan ata a i e 28 1 Introduction 1 1 Indications The Cardinal Health SVED system is an integrated wound management system indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids including wound exudates irrigation fluids body fluids and infectious materials The Cardinal Health SVED system is intended for patients with chronic acute traumatic subacute and dehisced wounds partial thickness burns ulcers such as diabetic or pressure flaps and grafts The Cardinal Health SVED system is intended for use in acute extended and home care settings 1 2 Contraindications The Cardinal Health SVED system is contraindicated for patients with malignancy in the wound untreated osteomyelitis non enteric and unexplored fistulas or necrotic tissue with eschar present Do not place the Cardinal Health NPWT Dressing over exposed blood vessels or organs The Cardinal Health NPWT Dressings are also contraindicated for hydrogen peroxide and solutions which are alcohol based or contain alcohol It is not recommended
33. of a trained clinician Wound irrigation is not intended for use in a Home setting NOTE Any solution cleared for use in topical wound irrigation can be used as the wound irrigant See 1 1 INDICATIONS 1 3 PRECAUTIONS and 1 4 ADDITIONAL PRECAUTIONS for more information on the suggested types of aqueous wound therapy solutions Make sure the irrigation fluid supply remains off until therapy is started and target pressure achieved 1 Obtain physician order for irrigation solution type and delivery rate 2 Connect irrigation tubing set attachment to irrigation solution container Close irrigation delivery set clamp completely 3 Hang irrigation bag on IV pole higher than the wound 4 Apply NPWT dressing as usual see section 3 1 APPLYING THE DRESSING Figure 17 5 Select desired location for Irrigation SpeedConnect port Cut a 1cm diameter hole in the top of the drape where the Irrigation SpeedConnect is to be placed Figure 18 a gt A D 5 Cc 74 d 5 6 Peel the backing from the Irrigation SpeedConnect port and place over hole made in Step 6 Figures 19 20 Using the tips of the fingers gently press around the Irrigation SpeedConnect port to ensure a good seal to the dressing Figure 21 Figure 18 Figure 19 To Irrigation To Irrigation 5 3 un gt c Ss H U Figure 20 Figure 21 Note The Irrigation SpeedConnect may be placed in close prox
34. power to the therapy device Battery Charging Port eo Canister Release e Power ON Power OFF 3 8 soo a Canister Full Low Pressure Leak a Therapy Timer Display A y F 150 mmHg 70 mmHg a h B 120 mmHg Figure 22 a gt A D 5 Cc 74 d 5 A E 3 u gt c Au 2 U 4 2 Power Up Procedure 1 Verify the dressing application is correct the tubing is connected the SpeedConnect tubing clamp is open 2 Keep the device in an upright position The device can be placed on a table or attached to an V pole using the I V Pole adapter but kept as level with or below the wound as possible CAUTION The I V pole clamp should only be used on poles that are in excess of 0 9 in 2 2 cm diameter and are securely attached to a bed frame or suitable stand To ensure stability of the therapy device on the 1 V 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 device cannot slide down the pole 3 Press the ON fon button All LED indicators will illuminate for 1 second during the power on self test after which the ON button will steadily light green 4 Dressing should collapse indicating the presence of vacuum 5 Carefully check dressing for vacuum or fluid leaks and repair with additional Polyurethane drape material as needed 6 The Cardinal Health SVED device shou
35. to deliver fluids to the thoracic cavity 1 3 Precautions Precautions should be taken for patients with infected wounds active bleeding difficult wound hemostasis or who are on anticoagulants When placing the Cardinal Health NPWT 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 1 4 Additional Precautions Defibrillation Remove the Cardinal Health NPWT 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 Cardinal Health SVED device is not MRI compatible Do not take the device 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 Large Canisters Use of Large Canisters gt 500ml may increase serious risks
36. where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80MHz and 800MHz the separation distance for the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 25 a gt A D 5 74 d 5 au 5 U N gt inician CI Guidance and Manufacturer s Declaration Electromagnetic Immunity IEC 60601 1 2 Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fasttransient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 KV air 2 kV for power supply lines 1 kV for input output lines 1kV line to line 2 kV line to earth lt 5 UT gt 95 dip in Ur for 0 5 cycle 40 UT 60 dip in Ur for 5 cycles 70 UT 30 dip in Ur for 25 cycles lt 5 UT 95 dip in Ur for 5 sec Compliance Level 6 kV contact 8 KV air 2 kV for power supply lines 1 kV for input output lines TKV line to line 2 KV line to earth lt 5 Uy gt 95 dip in Uy for 0 5 cycle 40 UT 60 dip in Ur for 5 cycles 70 UT 30 dip in Uy for
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