PRO, PRO to GO & PRO at HOME Clinician user manual
Contents
1. A D UM Lan 7 D 5 Figure 13 3 2 Canister Installation 1 Ensure that a Cardinal Health Canister is properly inserted in the connector located on the back side of the therapy 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 X ardinalHealth O ode an 1 Low Pressure leak E 2 Canister Full au W Battery Battery Charging Port E 4 Service Timer nc a W T monn N E 7 j NPWT Mm E o i y ath a 7 e _ Canister S g SP Figure 14 2 Inspect the SpeedConnect tubing port 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 tubing is open Figure 16 SpeedConnect Tubing Connector Canister Figure 15 a Power ON MUTE Power OFF a gt A D 5 UM D 5 Continuous Intermittent Mode Figure 16 4 Plug the device s A C Adapter into a suitable 100 240 VAC 50 60Hz outlet Ins2. CardinalHealth GO PRO PRO to NPS PRO at HOME L CLINICIAN USER MANUA Se Je X CardinalHealtty a 100 07 Pressure mmHg Pressure mmHg gt 29 Oro 8 Wen Pressure mmHg Oso Intermittent Oe Oso i a Intermittent Low Pressure leak Mode 2 Canister Full 3 Low Battery 1 TENE leak Si 2 Caister Ful ee 3 Low Battery Plugged In E 1 Low Pressure tenk 4 Service Timer 2 Canister Fu ES ee ge SN 3 3 Low Battery Plage In QE O 4 Service Timer Battery Charging Xy Plugged in E as gt Battery Charging SN O NPWT NPWT Moa BRO at HOME CAUTION This Cardinal Health NPWT PRO PRO to GO PRO at HOME herein after referred to as the Cardinal Health NPWT PRO family of devices 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 at 1 866 484 6798 In order for the Cardinal Health NPWT PRO family of devices to provide safe reliable and proper performance the following conditions must be met Failure to comply with these conditions will void all pertinent warranties e There are no user serviceable components in the Cardinal Health NPWT PRO family of devices All assembly operation adjustment modification main
3. the therapy will be discontinued e The LED display flashes 4 accompanied by 4 audible beeps every 10 seconds e Device is ready to be checked and serviced CORRECTIVE ACTION e Clamp the tubing If Low Pressure Leak LED and audible alarm reset there is a leak below the clamp often in the dressing Reopen the clamp before addressing the leak Gently press around drape to check for leaks If leak is found patch with extra drape material e 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 fully seated and locked Check for cracks in the canister or lid separation If found replace the canister Open the clamp e Clamp the tubing Turn device off by pressing the OFF button e Remove canister and replace Open the clamp and press the ON button to resume therapy e Utilizing an approved Cardinal Health A C Adapter connect device to an A C power source to provide operating power and to recharge the internal battery Return device to representative for service e This alarm cannot be manually reset by cycling power turning device OFF and ON This alarm cannot be MUTED NOTE Pressing the ON MUTE button after an alarm will silence the alarm for 5 minutes Alarm condition 4 cannot be manually reset by cycling power or Muted NOTE In the event ofan emergency please co
4. F 38 8 C 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 foam dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols 1 6 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 4 8 THERAPY SELECTION LOCK UNLOCK Lighted LEDs clearly indicate current therapeutic settings Light Weight Impact Resistant The Cardinal Health NPWT PRO family of devices weighs only 0 9 Ib 0 43 Kg and can be easily carried and transported The polymer enclosure is impact resistant to help prevent damage from dropping NoiseGuard Device is virtually silent in its normal operation with a well sealed dressing PowerGuard An internal battery provides up to 24 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 sound and the front panel LED display will indicate a low battery alarm condition when remaining capacity of the battery is less than 20 a gt A ES gt a MD g9 S oi S 3 u c A 2 U Self limiting Pump The pu
5. asii 47 5600 Cardinal Health NPWT PRO Carrying incida 47 9600 Cardinal Health SpeedConnect binden 47 2000 Cardinal Health NPW T Co rca iia 47 2500 Cardinal Health Polyurethane Drape 10 per pkg nn 47 7000 Cardinal Health SensiSkin Drape 10 per PKG ssscssssssssssssssosssssecsosssssssssessssesssseesssssnscsssssenecssseesuesensesssseees 47 7100 NOTE In order to assure the highest safety quality and efficacy of the products the Cardinal Health NPWT PRO family of devices should only be used with the Cardinal Health disposables and Cardinal Health NPWT Dressings should only be used with the Cardinal Health NPWT PRO family of devices 26 7 Questions amp Information For questions comments or additional information pertaining to the Cardinal Health NPWT PRO family of devices please contact your local Cardinal Health representative or Call our customer support professionals at 1 866 484 6798 Cardinal Health Waukegan IL 60085 www cardinalhealth com CustomerServiceNPWT cardinalhealth com 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 27 a gt A g9 gt Cc UM M g9 S oi 28 jenuew 1 sn ueniu gt ardinalHealth ial Cardinal Health 1500 Waukegan Road Waukegan IL 60085 USA 07 15 cardinalhealth com Cat 6708888 47
6. or latex free e Protective eyewear to help prevent splashing of cleaning solutions and or blood or bodily fluids e 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 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 a gt A D 5 a D 5 T 3 N c A H U 4 Operating Instructions This section contains instructions for setting and adjusting functions of the Cardinal Health NPWT PRO family of devices 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 NPWT PRO family of devices WARNING The Cardinal Health NPWT PRO family of devices 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 p
7. 0010 6702232 2015 Cardinal Health All Rights Reserved CARDINAL HEALTH the Cardinal Health LOGO SENSISKIN and SPEEDCONNECT are trademarks or registered trademarks of Cardinal Health US Pat 7 532 953 7 608 066 8 066 243 8 142 405 8 444 613 ECIREP EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands 0086
8. 2 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 NPWT PRO family of devices 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 Cardinal Health NPWT PRO family of devices 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 Use the lowest pressure setting on the Cardinal Health NPWT PRO family of devices over unstable body structures such as unstable chest wall or non intact fascia SPINAL CORD INJURY In the even
9. 4 SATIRE PON AE tonic een 14 g 3 5 Disposal of Dressings Canister and Other Disposables sssscsssssssssssscsssssssesssessssssssssnssssesesseessnessssssnssssesesess 15 a ER e 16 amp AT Power UN OFF nennen 16 AD Power DEI BU een 17 O 4 3 Therapy Setting Aca StIMGN Exc nannten 18 4 4 mtermittent Mode ON OFF ae 18 4 5 Alarm Volume A O 18 46 Battery Operaatio COP e nenne 19 47 Alarm A e een 20 A A 21 oe A E O OE O O E O A 22 A ta ha averusno ies ares UA NS Gane RE Aedes 23 5 2 Electromagnetic Compatibility sra id 24 6 Replacement Parts rips Ge icqeieesentinaincteni a elem ean recent 26 7 Questions amp ET NEL ea en nahe are taste en ee IE 27 1 Introduction 1 1 Indications The Cardinal Health NPWT PRO PRO to GO PRO at HOME systems are 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 NPWT PRO PRO to GO PRO at HOME systems are 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 NPWT PRO PRO to GO PRO at HOME systems are intended for use in acute extended and home care settings 1 2 Contraindications The Cardinal Heal
10. P 800 MHz to 2 5 GHz Conducted RF IEC 61000 4 6 3V rms where P is the maximum output power rating of the transmitter in watts W according to the transmitter 150 kHz 80 manufacturer and d is the recommended separation distance in meters m MHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey Radiated RF IEC 61000 4 3 a should be less than the compliance level 3V m in each frequency range 800 MHz 2 5 Interference may occur in the vicinity of equipment marked with the following symbol 5 GHz Note1 At 80 MHz and 800 MHz the higher frequency range applies 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 Ifthe measured field strength in the location in which the PRO is used exceeds the applicable RF compliance level above the PRO should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the PRO gt Over the frequency range 150 kHz to 80MHz fie
11. art number for the adapters can be found in the 6 REPLACEMENT PARTS section of this manual 4 1 Power ON OFF The ON and OFF E3 buttons are located on the front top of the control panel The ON E and OFF ES buttons control the application of power to the device gt i Power ON MUTE Power OFF Continuous Intermittent Mode 3 Low Battery 4 Service Timer Power Charging Status Figure 17 4 2 Power Up Procedure 1 Verify the dressing application is correct the tubing is connected and 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 I 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 2 2 cm diameter and are securely attached to a bed frame or suitable stand To ensure stability of the therapy device on the I 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 button All LED indicators will sequentially illuminate during the power on self test 4 Each time the device is turned on the systems goes through an initialization sequence including the front panel LED displaying a therapy timer feature NPWT PRO has a count up timer When the device is turn
12. 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 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 u 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 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 ofthe fingers press around the top ofthe SpeedConnect port 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 Figure 10 Figure 11 Figure 12 a gt
13. battery 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 80 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 20 See 4 7 ALARM OPERATION Typically the device 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 Battery Charging Port on the side of the therapy 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 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
14. 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 moving any fluid in the SpeedConnect tubing into the canister 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 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
15. d be that of a typical commercial and or line to line line to line hospital environment IEC 61000 4 5 2 kV 2 kV line to earth line to earth Voltage dips short lt 5 UT lt 5 UT Mains power quality should be that of a typical commercial and or hospital interruptions and voltage gt 95 dip in gt 95 dip in environment variations on power supply Ur for 0 5 cycle Ur for 0 5 cycle IEC 61000 4 11 40 UT 40 UT 60 dip in 60 dip in Ur for 5 cycles Ur for 5 cycles 70 UT 70 UT 30 dip in 30 dip in Uy for 25 cycles Ur for 25 cycles lt 5 UT lt 5 UT 95 dip in 95 dip in UT for 5 sec Ur for 5 sec Power frequency 50 60 Power frequency magnetic fields should be at levels characteristic of a typical Hz magnetic field IEC location in a typical commercial or hospital environment 61000 4 8 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 IEC60601 Compliance Level Electromagnetic Environment Test Level Guidance a gt A D D 5 Portable and mobile RF communications equipment should be used no closer to any part of the PRO including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter Recommend separation distance d 1 2 VP d 1 2 YP 80 MHz to 800 MHz d 2 3 Y
16. e 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 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 g9 UM M o S oi S 3 un gt c Au 2 U e During Negative Pressure Wound Therapy the Cardinal Health NPWT PRO family of devices 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 1 5 Safety Tips KEEP THERAPY ON The Cardinal Health NPWT PRO family of devices should be operated at least 22 hours out of every 24 hour period Remove the Cardinal Health NPWT 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 7
17. ed ON the display flashes 4 numbers XXXX which represent the number of hours the device has been in use NPWT PRO to GO has a count down timer When the device is turned ON the display flashes the letter d followed by two numbers XX representing remaining days then h followed by two numbers YY representing remaining hours NPWT PRO at HOME has a count down timer When the device is turned ON the display flashes the letter d followed by two numbers XX representing remaining days then h followed by two numbers YY representing remaining hours 5 Upon turning ON the device the dressing should slowly collapse indicating the presence of suction Once dressing integrity is verified adjust the device 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 Cardinal Health Polyurethane Drape if necessary 7 The Cardinal Health NPWT PRO family of devices 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 a gt ES UM M g9 S oi E 3 u c A U 4 3 Therapy Setting Adjustment CAUTION Only a physician can prescribe the proper settings and protocols for t
18. ert the power plug into the Battery Charging Port on the side of the device Figure 14 The Cardinal Health NPWT PRO family of devices 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 S 5 un gt c A H U 5 Verify the dressing application is correct the tubing is connected and the SpeedConnect tubing clamp is open 6 Begin therapy see 4 OPERATING INSTRUCTIONS 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 TIPS 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
19. he 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 the Pressure Setting There are five pressure settings available 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 UP button increases the pressure setting and the DOWN button decreases the pressure setting 1 When the device is powered up the current setting is selected automatically unless therapy setting has been locked previously by caregiver see 4 8 THERAPY SELECTION LOCK UNLOCK Section 2 To change the Pressure Setting press either the UP gt button or DOWN 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 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 intervention to correct 4 4 Intermittent Mode ON OFF The Cardinal Health NPWT PRO family of devices can operate in an intermitten
20. isual 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 ES Cc a MD g9 S oi E 3 un gt c Au H 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 NPWT PRO family of devices 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 NPWT PRO family of devices 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 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 Replacement A C Adapters are available fr
21. ld strengths should be less than 3 V m S 3 u gt c A 2 U 6 Replacement Parts Cardinal Health NPWT PRO family of devices Cardinal Health NPWT PRO device i unse 6708888 Cardinal Health NPWT PRO to GO device 47 0010 Cardinal Healthy NPWT PROat HOME device ten 6702232 Power Supply AC POU AAU I een 47 9100 Dressings Cardinal Health NPWT Small Foam Dressing Kit 10 per case s ssssccssscsseecsssccessecsssscessscessscesssecssnscesuseesnsessnes 47 1702 Cardinal Health NPWT Medium Foam Dressing Kit 10 per case e ssssessssecsssecssecssnseessscessesesssecsssscessecsnsessnee 47 1701 Cardinal Health NPWT Large Foam Dressing Kit 10 per CaS sssscsssessssecsssccessecssnscessscesssecesseccsnscesseesnsessaee 47 1700 Cardinal Health NPWT X Large Foam Dressing Kit 10 per case sescssssssssecsssccssesssnseessscesseecesseessneeesueesnsessees 47 1703 Cardinal Health White Foam Dressing 10 per CaS s ssssccssssssssecsssccesusecsssecsssccesuecesnseesuscesssccesseccsuscesneessnsessaes 47 1751 Canisters Cardinal Health Disposable Canister with Gel 300 cc 10 per CaS ssssssesssssessccsssessecsuccessesssccsseeesuecssccesseeses 47 4000 Cardinal Health Disposable Canister with Gel 500 cc 10 per CaS s ssscssescsssssscsssssessecssccessesssccssecssnecsseeesnecses 47 4500 Accessories Cardinal Health NPWT PRO I V Pole Holder
22. mp 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 Cardinal Health NPWT PRO family of devices can be set to operate intermittently 5 minute ON 2 minute OFF cycle Device maintains pressure at 25 mmHg during the OFF state to prevent loss of dressing seal 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 device 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 port facilitates connection to dressing Single Patient Use Canisters 300cc and 500cc canisters with and without gel solidifier for normal and highly exudating wounds CAUTION Use of large canisters gt 500cc 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 NPWT PRO family of devices The Caregiver should review this ma
23. ns equipment 5 3 y u c Au H U Output Power of Separation distance according to frequency of transmitter in meter s Transmitter in watt s 150kHzto80MHz 80MHzto800MHz 800MHzto2 5GHz 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 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 Guidance and Manufacturer s Declaration Electromagnetic Immunity IEC 60601 1 2 Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Test Level Guidance Electrostatic discharge 6 kV contact 6 kV contact Floor should be wood concrete or ceramic tile If floors are covered with ESD IEC 61000 4 2 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 Electrical fast transient 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial and or hospital burst 1 kV for input output 1 kV for input output environment Surge 1kV 1kV Mains power quality shoul
24. ntact 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 20 4 8 Therapy Selection Lock Unlock The Cardinal Health PRO family of devices is equipped with a therapy locking feature designed to prevent unauthorized individuals from inadvertently changing the therapeutic settings Locking To lock the device press and hold the ON button for three seconds until three audible beeps are heard At this point the device is locked The therapeutic setting will be recalled each time the device is powered OFF and ON and the device will remain locked until it is subsequently unlocked Unlocking To unlock the device press and hold the ON button until three 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 a gt D 5 UM D 5 21 3 u c Au A U 5 Specifications Cardinal Health NPWT PRO family of devices DIMENSIONS ana T ananadabaineses 6 x 4 3 x 2 75 in 19 3 x 11 0 x 7 0 cm o E e E 0 9 Lbs 0 43Kg A teins anena ascend n de E AEAEE 50 75 100 125 150 mmHg e e E O REEE 300cc 500cc With respect to electric shock fire and mechanical hazards conforms to IEC60601 1 IEC Classification e Medical E
25. nual 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 NPWT PRO family of devices 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 e Disposable gloves latex or latex free e Protective eyewear to help prevent splashing of cleaning solutions and or blood or bodily fluids e 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 components e Exudate collection canister e 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 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 v
26. om Cardinal Health WARNING The Cardinal Health NPWT PRO family of devices 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 therapy device Liquids can cause corrosion when left on electronic controls which can lead to failure Component failure may cause the therapy 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 Itis recommended that all sections of this manual be reviewed prior to using the product Carefully read the 1 1 INDICATIONS 1 2 CONTRAINDICATIONS 1 3 PRECAUTIONS and 1 5 SAFETY TIPS in the 1 INTRODUCTION section before attempting to perform patient care with the Cardinal Health NPWT PRO HC 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 p
27. quipment 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 e IPXO Battery Duration Fully Charged ana ete A up to 24 hours Electrical External Power Supply Input 100 240 VAC 50 60Hz 200 mA or 12 24 VDC 850 mA Optional External Power Supply Output arrasar ad 5 VDC 1 Amps Patient amp Enclosure leakage Current cornada miami lt 100 Micro amps Environmental Conditions Storage Conditions Temperature arrancan 10 F 12 C to 1100F 43 C Relative Humidity Range een 20 95 Non condensing Atmospheric Pressure ROTO circa ci 50 kPa to 110 kPa Operating Conditions Temperature Raney aaa atan ad 40 F 4 C to 90 F 32 C Relative Humidity Range a dad 20 75 Non condensing Atmospheric Pressure Range e 50 kPa to 110 kPa Service life of Quantum Wound Treatment SysteMm sssccsssssssssscssscsssessssssessssesssessssscenssecssseesansesanscssnssssansessseessses 3 years CAUTION Federal law restricts this device to sale by or on the order of a physician 22 5 1 Explanation of Symbols Consult Instructions for Use Power ON MUTE Power OFF Adjustment Button UP Adjustment Button DOWN Continuos Intermittent A C Power Status Battery Charge Status Class Il Internally Powered Equipment Type B Applied Part Alternating Cur
28. rent Not protected against the harmful effects of water Authorized Representative in the European Union Manufacturer Date of Manufacture Expiry Date Lot Batch Number Catalog Number Serial Number Storage Conditions Keep Dry Fragile Method of Sterilization Ethylene Oxide Rx Only 23 a gt g9 Cc UM MD g9 S oi 5 2 Electromagnetic Compatibility Guidance and Manufacturer s Declaration Electromagnetic Emissions IEC 60601 1 2 Electromagnetic Environment Harmonic emissions Class A The PRO is suitable for use in all IEC 61000 3 2 establishments 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 PRO is not suitable for interconnection CISPR 14 1 with other equipment Recommended separation distance between portable and mobile RF communications equipment and the PRO The PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PRO as recommended below according to the maximum output power of the communicatio
29. roximity 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 or 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 a gt ES gt Cc UM MD g9 S oi 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 7 Place the 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 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
30. t a patient experiences autonomic hyperreflexia sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system discontinue the use of the Cardinal Health NPWT PRO family of devices 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 NPWT PRO family of devices NOTE All dressing components of the Cardinal Health NPWT Dressing kit 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 Cardinal Health NPWT PRO disposable set are made without natural rubber latex Be sure to comply with all other 1 2 CONTRAINDICATIONS and 1 3 PRECAUTIONS for the Cardinal Health NPWT PRO family of devices 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
31. t suction mode with a 5 minute ON and 2 minute OFF cycle Press the Intermittent Mode button to turn the Intermittent Mode on and off During intermittent operation Cardinal Health NPWT PRO family of devices 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 device is OFF maintains the integrity of the seal to prevent leaks 4 5 Alarm Volume Adjustment 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 button while simultaneously pressing the UP button to increase the volume or the DOWN button to decrease the volume The LED display 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 6 Battery Operation NOTE The Cardinal Health NPWT PRO family of devices is designed to permit use of the product while the internal battery is charging The therapy device will continue to operate properly while the battery is charging Battery Life The specified battery life of the Cardinal Health NPWT PRO family of devices with a fully charged battery and a well sealed dressing is up to 24 hours The actual life is dependent on the integrity of the dressing A leak in the dressing can reduce overall
32. tenance 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 e 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 clinical caregiver may lead to improper product performance and the potential for serious or fatal injury a gt D 5 UM Lan 7 D 5 Table of Contents IN eb 3 A o A 3 A A o ie tra EEEE EE RERE 3 A o A ee 3 14 Additional Pr src r 3 A Ag A 4 1 6 Fall aorta raid ida 5 2 Care SEN OOO oo E eee marianne N N 7 JV o To ARPA E on AA ae 7 22 Protective EI diran ci 7 A A e o ro A 7 24 Daily Care and Cea aaa 7 2 5 Between Patient and Weekly Care and Cleaming s ssssssssssssssscsssesssnssessssesssscssnssesnscenssecssssecnnscensesssnssssanecensesssaes 8 O E Renee 9 3 1 Applying the DIESSIND nennen 9 E 32 ONE talla rra ici 12 3 3 Gnister Neal eco en nn end nee 1
33. th NPWT PRO PRO to GO PRO at HOME 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 foam dressing over exposed blood vessels or organs 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 NPWT PRO family of devices is not MRI compatible Do not take the device into th
34. the Cardinal Health NPWT PRO family of devices is disconnected from the AC power source the device will automatically switch over to the internal battery and continue to operate without interruption a gt g9 gt Cc a MD g9 S oi 6 3 N c S M U 4 7 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 Alarm Type 1 3 turn the therapy device OFF then ON The alarm will clear when the power is cycled Alarm Type 4 cannot be manually reset by cycling power or Muted ALARM TYPE FLASHING 1 LOW PRESSURE LEAK FLASHING 2 CANISTER FULL FLASHING 3 LOW BATTERY FLASHING 4 SERVICE TIMER Alarm Troubleshooting INDICATION e LED display flashes 1 accompanied by an intermittent single tone audible beep e Device will continue to alarm until the low pressure leak condition is corrected or the alarm is cleared e LED display flashes 2 accompanied by an intermittent two tone audible beep e Device will continue to alarm until the canister is replaced e The LED display flashes 3 accompanied by an intermittent three tone audible beep e The device will continue to alarm until connected to an A C power source e When the charge falls below a critical level
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