User Manual - MoblVac® portable wound care pump with
Contents
1. 19 Lock Function 3 3 28 20 Unlock Function 20 7 3 Battery Status Indicator 20 and 21 8 1 Processing and Cleaning Instructions 21 Washing 21 8 2 Battery Air Filter Replacement 21 23 9 1 Troubleshooting the MoblVac Unit 23 Patient Caregiver Information 29 10 1 Patient Caregiver Training Checklist 29 Important Contact Information 31 Parts 32 Parts at She 32 References a 33 MoblVac Wound Care Pump General 1 1 Symbols Signal words are used in this manual and apply to hazards or unsafe practices which could result in personal injury or property damage See the information below for definitions of the signal words A DANGER Danger indicates an imminently hazardous situation which if not avoided will result in death or serious injury WARNING Warning indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION Caution indicates a potentially hazardous situation which if not avoided may result in prope2. troubleshooting section of this manual To increase the vacuum pressure level press the button on the control panel beneath the word INCREASE 1176097A the button is pressed the display will increase increments of 25 mmHg and the pump will pulse to increase the actual vacuum being applied to the patient Once the pressure is stabilized the internal vacuum sensor will hold the pressure at 5 mmHg of the set point 13 To decrease the amount of vacuum pressure being applied to the patient press the button on the control beneath the word DECREASE until the desired pressure setting is reached The unit will slowly bleed down to the desired pressure If an immediate bleed down is required press the button beneath the word PAUSE on the control panel and wait five seconds for all the negative pressure to vent and then press the button beneath the word RUN on the control panel to restart the unit at the desired pressure Note that if the unit is left in the PAUSE mode for more the five minutes the alarm will sound 3 times to remind the user the pump is on Canister Alarm As the unit is running and evacuating fluid from the patient the collection canister will begin to become full it is entirely full the unit will automatically sense that the canister is full and the CANISTER ALARM will sound and the unit will automatically vent the pressu
3. 5 22 i Replace the air filter with only Invacare part number 769722 Replace the battery with only Invacare Part Number 769721 CAUTION Use of non approved batteries may cause damage to the unit and void the product warranty When reassembling wires to battery ensure that the white wire is placed on the positive red terminal and that the black wire is placed on the negative black terminal To prevent damage to the unit do not reverse the connection Place battery back into compartment and secure door with four screws i Ensure that none of the vents on the back of the unit are obstructed after reassembly The operator must repeat the preliminary check prior to placing the unit back into service 1176097A Troubleshooting 9 Troubleshooting 9 1 Troubleshooting the MoblVac Unit A Pump does not turn on when Battery is not charged Charge battery for a minimum of hour Ensure that when the power switch is depressed the DC adapter is connected the LCD screen illuminates and displays the battery icon If the screen does not illuminate when the DC adapter is connected charge the unit for a minimum of 4 hours Defective unit Call MoblVac Clinical Technical Hotline at 866 985 NPWT 6798 for assistance Can tell if pump is on Green light is not functioning The green light above the button on the front control panel indicates that the pump is turned on Check to see if the pump operate
4. Connect the locally supplied patient tube to the hose barb on the exterior of the collection canister 5 Depress the on off button on the front control panel of the unit Observe that the LED above the button illuminates and that the display shows the home screen with the MoblVac logo and the text Select Operating Mode to Begin 6 To operate the unit in CONTINUOUS suction mode for INTERMITTENT mode proceed to section B press the button on the control panel beneath the text CONTINUOUS the button is depressed the display will change to the CONTINUOUS VACUUM screen and the pump will pulse momentarily The digital gauge portion of the display shall then read 25 mmHg This is the actual vacuum that is being applied to the patient and is the default pressure setting After a few momentary pulses of the pump the unit shall become silent If the pump runs constantly and the unit goes into a leak alarm mode press the silence button on the control panel and check the patient dressing canister and tube connection for leaks the leaks have been sealed the pump will become silent If the unit continues to alarm please refer to the troubleshooting section of this manual To increase the vacuum pressure level press the button on the control panel beneath the word INCREASE Once the button is pressed the display will increase increment
5. Contraindications Risk Factors 8 Benefits de eR es Ses 8 8 3 2 Wound 10 3 3 Pressure 10 3 4 Dressing Changes 10 Initial 10 Subsequent Dressing Changes 10 Dressing in Place without MoblVac Therapy 10 3 5 Wound Monitoring 10 4 casa i ce le ign ese 12 4 1 Setup Delivery 12 5 Technical D ta 5 13 5 1 Typical Product Parameters 13 5 2 Definitions and Symbols Legend 13 6 Quick Start Instructions 15 6 1 Quick Start 5 15 AAPM 15 7 Operating Instructions 0 0 c cece eee eee 16 7 1 Operating Instructions for Constant Suction 16 2 05 4 ES 17 Disable Sleep Mode 17 Enable Sleep Mode 17 Lock Function ssai eeri eee a eee 17 Unlock Function 17 7 2 Operating Instructions Intermittent Suction 17 Canister Alarm 19 Disable Sleep Mode 19 Enable Sleep Mode
6. UNLOCK button buttons are now enabled Once the final selection is made the user can then press the RETURN button to return to the vacuum level screen 3 When therapy is complete press the on off button to turn the unit off and vent the negative pressure and disconnect the unit from patient 7 2 Operating Instructions Intermittent Suction Remove the collection canister from its packaging and place onto the housing rail 2 Depress the canister retaining latch and firmly press the canister into place 17 MoblVac Wound Care Pump 3 4 Release the latch ensuring it is firmly extended over the top of the canister Connect the locally supplied patient tube to the hose barb on the exterior of the collection canister Depress the on off button on the front control panel of the unit Observe that the LED above the button illuminates and that the display shows the home screen with the MoblVac logo and the text Select Operating Mode to Begin Press the button on the control panel beneath the word INTERMITTENT the button is depressed the display will change to Il the SET ON TIME screen and the number 4 will begin to flash Use the buttons on the control panel beneath the words INCREASE and DECREASE to set the prescribed ON time in minutes This is the interval that negative pressure will be applied
7. Checklist WARNING Monitor patient for excessive bleeding which may result in serious injury or death If sudden or increased bleeding is observed immediately stop therapy and seek medical attention This device is to be used by or under the care of trained medical personnel only DO NOT use this or any electrical device in an explosive or flammable environment or in the presence of flammable anesthetics Infected wounds may require more frequent dressing changes Constantly monitor wounds for signs of infection Negative pressure wound therapy NPWT is not approved for use on children Note to Healthcare Professional This checklist should be completed by the patient caregiver after training has been completed The checklist and the operation manual should be thoroughly reviewed by you prior to the NPWT system being released for in home use as it may provide opportunities to discuss additional questions or concerns of the patient caregiver or provide additional training Please ensure that the Important Contact Information section is completed 20 1176097A Patient Caregiver Information Operating the MoblVac Unit Did you receive training from a healthcare professional for example your doctor a nurse or a home healthcare provider so that you understand how to use your NPWT device Were you able to demonstrate to your trainer proper use of the NPWT device Instructions Did you get NPWT patient ca
8. Invacare MoblVac Wound Care Pump EN User Manual Select Operating Mode to Begin common POTENT TENT This manual MUST be given to the user of the product BEFORE using this product read this manual and save for future reference Yes you can 2011 Invacare Corporation All rights reserved Republication duplication or modification in whole or in part is prohibited without prior written permission from Invacare Trademarks are identified by and All trademarks are owned by or licensed to Invacare Corporation or its subsidiaries unless otherwise noted Facilities should refer to their clinical practice guidelines for appropriate settings of NPWT Kerlix AMD and Covidien are trademarks of Covidien AG or its affiliate COUMADIN is a registered trademark of Bristol Myers Squibb LOVENOX is a registered trademark of Sanofi Aventis Corp Plavix is a registered trademark of Sanofi Aventis Corp and the Bristol Myers Squibb Sanofi Pharmaceuticals Partnership MoblVac and Ohio Medical Corporation are registered trademarks and TruSeal is a trademark of Ohio Medical Corporation Contents De General 4 1 1 Symbols 2 Ge 4 1 2 7040 ANE Gro ei te 4 2 Safety she eas ay gs Gee ahs ells 6 2 1 General Guidelines 6 Clinical Considerations Guidelines 8 3 1 Indications
9. NENT WITHOUT THE SPECIFIC CONSENT OF ICCI OR TO A PRODUCT DAMAGED BY CIRCUMSTANCES BEYOND ICCI S CONTROL AND SUCH EVALUATION WILL BE SOLELY DETERMINED BY ICCI THE WARRANTY SHALL NOT APPLY TO NORMAL WEAR AND TEAR OR FAILURE TO ADHERE TO THE PRODUCT INSTRUCTIONS THE FOREGOING EXPRESS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY OTHER WARRANTIES WHATSOEVER WHETHER EXPRESS OR IMPLIED INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND THE SOLE REMEDY FOR VIOLATIONS OF ANY WARRANTY WHATSOEVER SHALL BE LIMITED TO REPAIR OR REPLACEMENT OF THE DEFECTIVE PRODUCT PURSUANT TO THE TERMS CONTAINED HEREIN THE APPLICATION OF ANY IMPLIED WARRANTY WHATSOEVER SHALL NOT EXTEND 1176097A General BEYOND THE DURATION OF THE EXPRESS WARRANTY PROVIDED HEREIN SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES WHATSOEVER MoblVac Wound Care Pump 2 Safety 2 1 General Guidelines WARNING Do not use this product or any available optional equipment without first completely reading and understanding these instructions and any additional instructional material such as owner s manuals service manuals or instruction sheets supplied with this product or optional equipment If you are unable to understand the warnings cautions or instructions contact a healthcare professional dealer or technical personnel before attempting to use this equipment otherwise injury or
10. d there is a dressing leak Readjust the seal as necessary and reapply suction Defective extension tubing canister or Follow instructions below for Problem D unit 1176097A D Erratic leak alarm Improper tubing connection or leak in the patient dressing Canister is not sealed properly to housing Dirt or contaminate on the collection canister seal Canister is cracked or defective Exhaust vents are obstructed Defective unit Keep screen illuminated Sleep Mode Feature disable sleep mode 1176097A Troubleshooting Check all patient vacuum connections to ensure they are air tight and that the tubing is connected properly to the collection canister Clamp the drain tubing and observe the wound site to check for leaks in the dressing If the dressing noticeably grows in size and then shrinks again when the clamp is released there is a dressing leak If the alarm is silenced when the clamp is applied there is a dressing leak Readjust the seal as necessary and reapply suction Firmly press on the canister in a downward motion while the pump is running to ensure a proper seal Press the PAUSE button and remove the collection canister Visually inspect the sealing area on the canister and the housing and remove any debris or contaminate that is compromising the seal Replace canister and restart When the pump is running the user should not manually occlude the brass vacuum port If occludin
11. damage may occur Accessories Invacare products are specifically designed and manufactured for use in conjunction with Invacare accessories Accessories designed by other manufacturers have not been tested by Invacare and are not recommended for use with Invacare products The information contained in this document is subject to change without notice Check all parts for shipping damage and test before using In case of damage do NOT use Contact Invacare Carrier for further instruction This product is a medical device and sale is restricted to or by order of a physician This device must only be used for the person for whom it was ordered and only for the use for which it was intended WARNING Monitor patient for excessive bleeding which may result in serious injury or death If sudden or increased bleeding is observed immediately stop therapy and seek medical attention This device is to be used by or under the care of trained medical personnel only DO NOT use this or any electrical device in an explosive or flammable environment or in the presence of flammable anesthetics Infected wounds may require more frequent dressing changes Constantly monitor wounds for signs of infection Negative pressure wound therapy NPWT is not approved for use on children CAUTION Prior to application of NPWT it is the responsibility of the medical professional to properly assess the wound and to ens
12. eep mode disabled Even when sleep mode is disabled the screen will still dim one minute after the last button is pressed 1176097A 6 Quick Start Instructions 6 Quick Start Instructions Remove the collection canister from its packaging Firmly press the canister into place Ensure the latch is firmly extended over the top of the canister Connect the extension tubing to the opening on the top of the collection canister Depress the button on the front control panel of the unit and notice that the green light goes on Press the button on the control panel beneath the text CONTINUOUS unless you have been told to apply intermittent therapy The digital gauge portion of the display will 25 mmHg Increase the pressure to the level have been instructed by the physician by pressing the button on the control panel beneath the word INCREASE The display will increase in increments of 25 mmHg When therapy is complete press the button to turn the unit off and disconnect the unit from patient o Refer to instructions on the back of the MoblVac unit For more information call 866 985 NPWT 6798 or visit www MoblVacNPWT com for the MoblVac Manual Alarms Canister Full Alarm The alarm will sound when the canister is full Press the PAUSE button and remove the collection canister Replace with a new canister and restart For instructions on how to replace canister please refer to
13. en the unit is plugged into wall power The battery will drain very quickly with sleep mode disabled Lock Function l Press the OPTIONS button from the vacuum level screen 2 Press the LOCKOUT button lock icon appears next to the battery level indicator All of the buttons on the unit are now disabled Unlock Function l Press and hold the HOLD TO UNLOCK button 2 Press the flashing UNLOCK button o The buttons are now enabled Once the final selection is Il made the user can then press the RETURN button to return to the vacuum level screen 3 When therapy is complete press the on off button to turn the unit off and vent the negative pressure and disconnect the unit from patient 7 3 Battery Status Indicator Assuming fully charged battery and a good dressing seal the approximate battery life of a fully charged battery is 12 hours During operation the unit will continuously monitor the state of the battery The segments of the battery status monitor are defined as follows e Green battery charged 20 e Yellow battery partially charged Red battery needs charging e Blank and Flashing Battery nearly depleted Plug immediately This battery status indicator is approximate and is based upon properly set up and sealed dressing If the pump is turned on without a collection canister and dressing in place the colored bands in the battery sta
14. full 30 Excessively frequent canister replacement may be a sign of excessive bleeding Dispose of used canisters in accordance with local ordinances regarding disposal of potentially infected or bio hazardous materials Do not open canister Do not block the vents on the battery cover Ensure that all previous dressing materials are removed prior to new dressing application Did you ask your healthcare professional whether you need to stop taking aspirin or any other medications that affect bleeding or blood clotting and what the associated risk is of stopping or avoiding such medicines Are you comfortable using the NPWT device at home If your answer is NO advise your healthcare professional 1176097A Patient Caregiver Information Important Contact Information Your nurse s name Your nurse s number Your doctor s name Your doctor s number MobIVac Clinical Technical Support toll free 866 985 NPWT 6798 Product Number Product Serial Number 1176097A 31 MoblVac Wound Care Pump Parts List Other available accessories 11 1 Parts List 769703 Collection Canister with MoblVac Wound Care Pump Solidifier 769703 NS Collection Canister without Solidifier 769600 MoblVac Portable Wound Care Pump includes pump with quick start guide FU manual tubing set power cord collection canister with solidifier 769605 Replacement Power Supply 769700 Moblvac Pre
15. g of this port occurs the unit is designed to automatically shut down Replace collection canister Remove obstruction from exhaust vents on back of unit Call MoblVac Clinical Technical Hotline at 866 985 NPWT 6798 for assistance Follow instructions above for Problem B 25 MoblVac Wound Care Pump Erratic canister alarm 26 Unit is not completely upright causing fluid to prematurely sound alarm Contaminate on canister alarm contact area Defective unit Unit must be used in completely upright position Press the PAUSE button and remove the collection canister Visually inspect the electrical contact area on the canister and the housing and remove any debris or contaminate that is compromising the electrical connection Replace canister and restart Call MoblVac Clinical Technical Hotline at 866 985 NPWT 6798 for assistance 1176097A Troubleshooting No vacuum to patient Unit is in the PAUSE mode Press RUN button Unit is in the OFF cycle during Wait for the OFF cycle to finish timing and the unit will cycle intermittent mode to the ON Collection canister is full and alarm has Replace collection canister and restart unit been silenced Pressure regulator is set at zero Press INCREASE button to raise vacuum pressure Tubing is clamped Visually inspect the clamps on extension tubing and drain tubing Ensure the
16. lines should not be relied upon to suggest a course of treatment for a particular person The guidelines should not be used in place of a visit call consultation or the advice of a licensed physician or other qualified healthcare provider Patients with healthcare related questions or concerns are advised to contact a physician or other qualified healthcare provider promptly Invacare makes no representations or warranties concerning the content or clinical efficacy or effectiveness of the guidelines MoblVac Wound Care Pump 4 Setup 4 1 Setup Delivery Inspection Inspect package for completeness Ensure that you have received all of the following materials with your MoblVac Wound Care Pump Item number 769600 One pump with quick start guide operator s manual e tubing set e power cord e collection canister with solidifier If you are missing anything please call the MoblVac Clinical Technical Services Hotline at 866 985 NPWT 6798 Visually inspect unit for physical damage that may have occurred during shipping Without connecting the DC adapter depress the button to turn the unit ON and observe the display and ensure it illuminates to show MoblVac and Select Operating Mode to Begin If the display does not illuminate connect the DC adapter and observe the display and ensure the battery symbol appears Allow the battery to charge for at least one hour and then repeat step tw
17. mium Transport Dressing Kits Bag Tri Fold packaging with instructions for use 769606 Pole Clamp 769812 TruSeal Link Woundcare Kit Value 769813 TruSeal Link Woundcare Kit Economy 769814 TruSeal Link Woundcare Kit Medium Channel 769815 TruSeal Link Woundcare Kit Small Round 769816 TruSeal Link Woundcare Kit X Large Round 769804 TruSeal Link Seal Kit 32 1176097A 12 References 1 Argenta LC Morykwas MJ Vacuum assisted closure a new method for wound control and treatment clinical experience Ann Plast Surg 1997 38 563 576 577 2 Ballard K Baxter H Vacuum assisted closure Nurs Times 2001 97 5 1 52 3 Webb LX Perspectives on modern orthopaedics new techniques in wound management vacuum assisted wound closure Am Acad Orthop Surg 2002 10 303 311 4 Alvarez AA Maxwell GL Rodriguez GC Vacuum assisted closure for cutaneous gastrointestinal fistula management Gynecol Oncol 200 1 80 4 13 416 5 Garner GB Ware DN Cocanour CS et al Vacuum assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens Am J Surg 2001 182 630 638 6 Miller PR Thompson JT Faler et al Late fascial closure in lieu of ventral hernia the next step in open abdomen management J Trauma 2002 53 843 849 7 Long M A Blevins A Options in Negative Pressure Wound Therapy Wound Ostomy Continence Nurs 2009 36 2 202 21 1 8 Wackenfors A Sjogren amp Gus
18. nd depth e reduction in undermining and tunneling 1176097A e reduction in drainage Discomfort e apply non adherent contact layer to wound bed before antimicrobial gauze e investigate for underlying cause Complications e Monitor patients for excessive bleeding which may cause serious injury or death If bleeding is excessive stop therapy Call 911 or local emergency number unless the patient is already hospitalized and take emergency measures to control bleeding e Monitor patients for infection If odor or clinical signs of infection are noted contact the treating clinician immediately Battery and Canister e Check that the battery is charged The canister should be changed at least once a week or when 2 3 full e Dispose of used canisters in accordance with local ordinances regarding disposal of potentially infected or biohazardous materials Do not open canister e Excessively frequent canister replacement may be a sign of excessive bleeding Do not block the vents on the battery cover 1176097A o Clinical Considerations Guidelines Refer to instructions on the back of the MoblVac pump and with the dressing kit For more information call 866 985 NPWT 6798 for the MoblVac Manual and dressing kit Instructions for Use These guidelines reflect the clinical experiences and opinions of our consultants The guidelines are presented for the purpose of providing information concerning NPWT The guide
19. nd lift the canister off of the support rail 4 Dispose of the canister using proper disposal procedures 5 Install a new canister Refer to steps 3 in Operating Instructions for Constant Suction 6 Press the button on the control panel beneath the word RUN to restart the suction unit Disable Sleep Mode l Press the OPTIONS button 2 Press the SLEEP OFF button These steps will disable the sleep mode and the screen Il will remain illuminated After sleep mode is turned off the text above the button will read SLEEP ON Enable Sleep Mode l Press the OPTIONS button 2 Press the SLEEP ON button 1176097A Operating Instructions These steps will enable the sleep mode After sleep mode is turned the text above the button will read SLEEP OFF 3 the final selection is made the user can then press the RETURN button to return to the vacuum level screen It is recommended that the user only disable the sleep mode when the unit is plugged into wall power The battery will drain very quickly with sleep mode disabled Lock Function l Press the OPTIONS button from the vacuum level screen 2 Press the LOCKOUT button lock icon appears next to the battery level indicator All of the buttons on the unit are now disabled Unlock Function Press and hold the HOLD TO UNLOCK button 2 Press the flashing
20. neuropathic and diabetic wounds e explored enterocutaneous fistulas e leg ulcers e traumatic wounds e fasciotomy wounds from compartment syndrome Benefits The potential clinical benefits of NPWT include increasing local blood flow accurate measurement of wound exudates decreasing microbial bioburden enhancing formation of granulation tissue and wound contraction and promoting epithelialization Contraindications WARNING Always consult the patient s physician before using the MoblVac system The MoblVac NPWT pump should not be used under the following conditions necrotic tissue with eschar present e untreated osteomyelitis non enteric or unexplored fistulas e malignancy in wound e exposed vasculature e exposed nerves e exposed anastomotic site e exposed organs 1176097A Clinical Considerations Guidelines WARNING WARNING Precautions Patient Risk Factors Characteristics to The following is a continued list of health factors that consider before NPWT use your healthcare provider has been advised to consider The following is a list of health factors that your before prescribing use of the MoblVac as part of healthcare provider has been advised to consider your medical treatment before prescribing use of the MoblVac as part of i e Patients requiring your medical treatment If you have any questions or concerns about these risk factors consult with your MRI healthcare profes
21. ns and Symbols Legend Collection Canister is Full A LEAK ALARM A System Leak Detected MoblVac Wound Care Pump Continuous Vacuum Mode A constant vacuum pressure is applied based upon pressure level set by operator Intermittent Vacuum Mode Unit will automatically cycle negative pressure and atmospheric pressure based upon the timing level set by the operator Vacuum Level The operator can use the control panel to set the desired vacuum pressure level in increments of 25 mmHg Pause The operator can use the control panel to pause the unit and vent the negative pressure in order to make adjustments to the setup Run The operator can use the control panel to restart the pump after adjustments are made Silence The operator can use the control panel to silence the audible alarm in order to rectify the adverse condition Options The operator can push the options button in order to turn sleep mode off or to utilize the lockout mode Lockout The lockout mode protects the unit from inadvertent button pushes and requires a two step button combination to be disabled This feature will ensure that the vacuum level is not mistakenly changed during therapy Sleep Off This option allows the user to turn off the sleep mode and will keep the LCD display illuminated at all times o It is recommended that the user only disable the sleep mode when the unit is plugged into wall power The battery will drain very quickly with sl
22. nts who are colonized Sharp edges in the wound i e bone fragments with exotic organisms Spinal cord injury stimulation of sympathetic nervous system Enteric fistulas 1176097A 9 MoblVac Wound Care Pump 3 2 Wound Preparation Debride necrotic tissue from wound bed 2 Cover tendon bone vessels or organs with non adherent dressing such as oil emulsion 3 apply skin barrier to periwound skin 4 Cover any area of intact skin that may come in contact with dressing 3 3 Pressure Levels There are many studies in NPWT with pressures ranging from 60 to 125 mmHg In studies using gauze based NPWT pressure settings of 60 80 mmHg are frequently cited as being less painful and minimizing the risk of bleeding and tissue damage This corresponds to a MoblVac setting of 75 mmHg Consult with your physician and facility protocol in setting appropriate pressure levels The MoblVac system supports continuous and intermittent therapy Continuous therapy is recommended for unstable structures such as chest wall or non intact fascia for patients with increased risk of bleeding highly exudating wounds and enteric fistulas Intermittent therapy is considered after the first 48 hours in treating some wound types The following guidelines are general recommendations Consult with your physician and facility protocols NPWT Continuous therapy Continuous therapy Continuous therapy for first 48 wounds hours Con
23. o of the preliminary check procedure If the unit has been stored for an extended period of time the screen may not illuminate when the power adapter is initially plugged in but the battery will continue to charge Allow the unit to charge for a minimum of four hours and repeat step 2 of the Preliminary Check 1176097A 5 Technical Data 5 1 Typical Product Parameters DEVICE SPECIFICATIONS Pump 12 VDC oil less diaphragm type Performance Vacuum Range 0 200 mmHg Controls Vacuum Regulator Integrated Digital Pressure Transducer Vacuum Gauge LCD TFT Display 1 Full Scale Accuracy Battery Type Rechargeable Sealed Lead Acid Capacity 12V 1 2 Ah Average Run Time 12 hours at Full Charge Run time may vary based on effectiveness of dressing seal Charge Time 6 hours or less to 85 charging Collection Device Canister 500cc Disposable Plastic w Integrated Odor Control Filter and Electrical Shutoff 1176097A Technical Data DEVICE SPECIFICATIONS Electrical Requirements 100 240 VAC 50 60 Hz 1 5 0 7 A 24 V DC 9 Use only power supply model number SNP A049 M3 Manufactured by Skynet Electronics Operating Shipping and Storage Temperature range within 40C to 70C Relative humidity range within 10 to 95 N C Atmospheric pressure range within 500 to 1060 kPa Electrical Classifications Class Internally Powered Type B Applied Part IPXO Ordinary 5 2 Definitio
24. re from the patient tube Press the button on the control panel beneath the word SILENCE to turn the alarm off 2 Disconnect the patient tube from the collection canister 1176097A Operating Instructions 3 Press the canister lock inward towards the housing and lift the canister off of the support rail 4 Dispose of the canister using proper disposal procedures A WARNING The full canister contains biohazardous material Always use universal precautions when handling and disposing of a full collection canister 5 Install a new canister Refer to steps 3 in Operating Instructions for Intermittent Suction 6 Press the button on the control panel beneath the word RUN to restart the suction unit Disable Sleep Mode l Press the OPTIONS button 2 Press the SLEEP OFF button These steps will disable the sleep mode and the screen Il will remain illuminated After sleep mode is turned off the text above the button will read SLEEP ON Enable Sleep Mode l Press the OPTIONS button 2 Press the SLEEP ON button These steps will enable the sleep mode After sleep mode is turned the text above the button will read SLEEP OFF 3 the final selection is made the user can then press the RETURN button to return to the vacuum level screen MoblVac Wound Care Pump Itis recommended that the user only disable the sleep mode wh
25. regiver instructions from your doctor or Invacare representative If YES please keep these instructions where you can easily find them If NO please call your healthcare provider or distributor Complications Do you understand that there may be some risks when using this device Has your healthcare provider explained the risks to you 29 MoblVac Wound Care Pump WARNING Call your healthcare provider immediately if there is change the color or amount of fluid in the canister The canister fills quickly with blood The dressing leaks fluid or fails to seal If the wound smells bad If the wound gets worse If you experience increased pain or discomfort This may indicate excessive bleeding which may cause serious injury or death If there is excessive bleeding stop therapy immediately Call 911 or local emergency number and take emergency measures to control bleeding This may indicate an infection Monitoring these items should be checked periodically have been instructed on how to check and or complete the following Ensure that vacuum is being applied to your wound that vacuum is Ensure that vacuum is being applied to your wound applied to your wound Check that the battery is charged that the Check that the battery is charged is charged Check the canister to see if it needs to be changed the canister should be changed at least once a week or when 2 3
26. rty damage or minor injury or both IMPORTANT Indicates a hazardous situation that could result in damage to property if it is not avoided Gives useful tips recommendations and information for Il efficient trouble free use 1 2 Warranty PLEASE NOTE THE WARRANTY BELOW HAS BEEN DRAFTED TO COMPLY WITH FEDERAL LAW APPLICABLE TO PRODUCTS MANUFACTURED AFTER JULY 4 1975 This warranty is extended only to the original purchaser who purchases this product when new and unused from Invacare Continuing Care Inc ICCI or a dealer This warranty is not extended to any other person or entity and is not transferable or assignable to any subsequent purchaser or owner Coverage under this warranty will end upon any such subsequent sale or other transfer of title to any other person This warranty gives you specific legal rights and you may also have other legal rights which vary from state to state ICCI warrants this product when purchased new and unused will be free from defects for a period of one 1 year from date of purchase from ICCI or a dealer with a copy of the seller s invoice required for coverage under this warranty If within such warranty periods any such product shall be proven to be defective such product shall be repaired or replaced at ICCl s option This warranty does not include any labor or shipping charges incurred in replacement part installation or repair of any such product ICCl s sole obligation and your exclu
27. s and screen illuminates If the green light does not illuminate please call MoblVac Clinical Technical Hotline at 866 985 NPWT 6798 for assistance 1176097A 23 MoblVac Wound Care Pump tell if pump is on C Pump continues to pulse or chirp after initiating therapy 24 Sleep Mode Feature The green light above the button on the front control panel indicates that the pump is turned on To conserve energy the pump goes into sleep mode and the screen is not illuminated Touch any button to illuminate the screen disable the energy conserving sleep mode press the Il OPTIONS button then press the SLEEP OFF button This will disable the sleep mode and the screen will remain illuminated After sleep mode is turned off the text above the button will change to read SLEEP ON Pressing the button again will enable the sleep mode Once the final selection is made the user can then press the RETURN button to return to the vacuum level screen It is recommended that the user only disable the sleep mode when the unit is plugged into wall power The battery will drain very quickly with sleep mode disabled Battery not charged or defective unit Follow instructions above for Problem A Leak in dressing Clamp the drain tubing and observe the wound site to check for leaks in the dressing If the dressing noticeably grows in size and then shrinks again when the clamp is release
28. s of 25 mmHg and the pump will pulse to increase the actual vacuum being applied to the patient Once the pressure is stabilized the internal vacuum sensor will hold the pressure at 5 mmHg of the set point To decrease the amount of vacuum pressure being applied to the patient press the button on the control beneath the word DECREASE until the desired pressure setting is reached The unit will slowly bleed down to the desired pressure If an immediate bleed down is required press the button beneath the word PAUSE on the control panel and wait five seconds for all the negative pressure to vent and then press the button beneath the word RUN on the control panel to restart the unit at the desired pressure Note that if the unit is left in the PAUSE mode for more than five minutes the alarm will sound 3 times to remind the user that the pump is on 1176097A Canister Alarm As the unit is running and evacuating fluid from the patient the collection canister will begin to become full it is entirely full the unit will automatically sense that the canister is full and the CANISTER ALARM will sound and the unit will automatically vent the pressure from the patient tube Press the button on the control panel beneath the word SILENCE to turn the alarm off 2 Disconnect the patient tube from the collection canister 3 Press the canister lock inward towards the housing a
29. section 9 part B on page 10 If the unit continues to alarm please refer to the troubleshooting section of this manual Excessive canister 1176097A Quick Start Instructions changes or canister full alarms may indicate that there is excessive bleeding Leak Alarm If the pump runs constantly and the unit goes into a leak alarm mode press the SILENCE button on the control panel and check the patient dressing canister and tube connection for leaks Once the leaks have been sealed the pump will become silent If the unit continues to alarm please refer to the troubleshooting section of this manual The leak alarm indicates that there is a leak in the dressing This may be due to improper application patient movement or excessive bleeding Battery Alarm The alarm will sound when the battery needs recharging Plug the electric cord into an electric outlet to charge the battery MoblVac Wound Care Pump 7 Operating Instructions 7 1 Operating Instructions for Constant Suction Upon receiving your new MoblVac pump perform the following initial tests to ensure that your unit is in good working order and that no damage has occurred during shipment 1 Remove the collection canister from its packaging and place onto the housing rail 2 Depress the canister retaining latch and firmly press the canister into place 3 Release the latch ensuring it is firmly extended over the top of the canister 4
30. sider intermittent therapy for duration if exudate is stabilized Type of Wound Abdominal Wounds Enteric Fistulas Other NPWT indicated 3 4 Dressing Changes Initial Application The TruSeal Link dressing kits should be changed 48 hours after the initial application of therapy Subsequent Dressing Changes If the patient is comfortable and if no leak is present dressing changes should occur 2 3 times per week The TruSeal Link dressing kits use Kerlix AMD antimicrobial gauze by Covidien which has been clinically proven to maintain an active healing environment and reduce the risk of infection for up to 72 hours 3 WARNING Dressings should be checked at regular intervals In the event of heavy drainage or drainage with sediment more frequent dressing changes may be needed Infected wounds may require more frequent dressing changes Consult with your physician and facility protocol in determining dressing changes Ensure that all previous dressing materials are removed prior to new dressing application Dressing in Place without MoblVac Therapy If MoblVac Negative Pressure Wound Therapy is interrupted the dressing may be left in place up to 72 hours from the initial application of that dressing according to clinical documentation from the gauze dressing manufacturer 3 3 5 Wound Monitoring Monitor for effective therapy resulting e reduction in wound surface area e reduction in wou
31. sional Hyperbaric chamber Defibrillation e Patients at high risk for bleeding and hemorrhage e Patients on anticoagulants or platelet aggregation inhibitors common types of blood thinners antiplatelets include but are not limited to COUMADIN warfarin heparin LOVENOX aspirin Plavix etc as excessive bleeding may occur If you are unsure please check with your physician Always advise your physician of all medications you are taking This includes both prescription medicines and those you buy over the counter e Patients with e Patient size and weight e Use near vagus nerve bradycardia such as neck or anorectal wounds where the vagus nerve may be exposed e Circumferential dressing application in an extremity e Mode of therapy intermittent versus continuous negative pressure e Position the device and tubing to avoid a tripping hazard and to avoid the patient lying on the tubing or otherwise pulling it from the wound site which could cause additional wounds DO NOT apply skin prep wipes directly onto open Friable vessels and infected blood vessels wounds Vascular anastomosis Take extra precaution to ensure a sterile Infected wounds environment when NPWT is used on patients who Osteomyelitis are immuno suppressed such as patients with HIV Exposed organs vessels nerves tendon and undergoing chemotherapy with transplants or on ligaments certain medications or patie
32. sive remedy under this warranty shall be limited to such repair and or replacement For warranty service please contact the dealer from whom you purchased your ICCI product In the event you do not receive satisfactory warranty service please write directly to ICCI at the address on the back cover provide dealer s name address and the date of purchase indicate nature of the defect and if the product is serialized indicate the serial number Do not return products to our factory without our prior consent 1176097A Any product returned must be free from contamination by toxic or hazardous substances in accordance with OSHA HAZARD COMMUNICATION STANDARD 29 CFR Section 1910 1200 and OSHA BLOOD BORNE PATHOGEN STANDARD 29 CFR Section 1910 1030 Decontamination of items prior to their return is the responsibility of the customer In the event a returned item is found to be contaminated it shall be regarded as regulated waste and disposed of and no credit for the item shall be issued to the customer LIMITATIONS AND EXCLUSIONS THE FOREGOING WARRANTY SHALL NOT APPLY TO SERIAL NUMBERED PRODUCTS IF THE SERIAL NUMBER HAS BEEN REMOVED OR DEFACED PRODUCTS SUBJECTED TO NEGLIGENCE ACCIDENT IMPROPER OPERATION MAINTENANCE OR STORAGE PRODUCTS MODIFIED WITHOUT ICCI S EXPRESS WRITTEN CONSENT INCLUDING BUT NOT LIMITED TO MODIFICATION THROUGH THE USE OF UNAUTHORIZED PARTS OR ATTACHMENTS PRODUCTS DAMAGED BY REASON OF REPAIRS MADE TO ANY COMPO
33. tafsson R Effects of vacuum assisted closure therapy on inguinal wound edge microvascular blood flow Wound Repair and Regeneration 23004 12 6 600 606 9 Willy C ed The Theory and Practice of Vacuum Therapy Scientific Basis Indications for Use Case Reports Practical Advice Ulm Germany Lindqvist Book Publishing 2006 10 Usopov YN Yepifanov MV Active wound drainage Vestnik Khirugii 1987 4 42 45 1176097A References 11 Shah C B Swogger E amp James 2006 July Efficacy of AMD dressings against MRSA and VRE White Paper Montana State University Bozeman MT Retrieved from Covidien Tyco Healthcare Group LP website Mansfield MA Covidien Tyco Healthcare Group LP 12 Fleck C A 2006 May Fighting infection in chronic wounds Advances in Skin amp Wound Care 19 4 184 188 13 Gilbert P n d Polyhexamethylene biguanides and infection control University of Manchester UK School of Pharmacy and Pharmaceutical Sciences Microbial Physiology 33 Notes Notes USA One Invacare Way Elyria Ohio USA 44036 2125 866 985 NPWT 6798 Manufactured by Ohio Medical Corporation INVACARE 1176097 A 2011 12 21 MOAT Yes you can
34. to the patient Once the desired time is set press the ENTER button and observe that the number 63 beneath the SET OFF TIME heading begins to flash Use the buttons on the control panel beneath the words INCREASE and DECREASE to set the prescribed OFF time in minutes This is the interval that negative pressure will be vented from the patient 10 Once the desired time is set press the ENTER button o If at any time while setting the OFF timing the operator desires to readjust the timing press the BACK button to return to the SET ON TIME option Once the correct timing is set and the ENTER button is pressed the display will change to the INTERMITTENT VACUUM MODE screen and the pump will pulse momentarily The digital gauge portion of the display shall then read 25 mmHg This is the actual vacuum that is being applied to the patient and is the default pressure setting After a few momentary pulses of the pump the unit shall become silent This will also commence the intermittent timing cycle If the pump runs constantly and the unit goes into a leak alarm mode press the SILENCE button on the control panel and check the patient dressing canister and tube connection for leaks i Once the leaks have been sealed the pump will stop running and become silent if the unit continues to alarm please refer to the
35. tus indicator may fluctuate until the system is properly sealed Once the battery is charged the battery status monitor will stop ascending and will become a solid red yellow and green segmented display The plug icon will remain until the DC adapter is disconnected On average a fully charged battery will yield approximately 12 hours of continuous use with a properly sealed dressing Never store the unit with a discharged battery This will decrease the overall shelf life of the battery Once therapy is complete it is recommended to fully charge the battery prior to storing the device If the unit is to sit dormant for an extended period of time it is recommended to charge the battery for a minimum of four hours every month to maximize the life of the battery A CAUTION The power cord is be used for mains disconnection Always use the power cord to disconnect the unit from the outlet 1176097A 8 Care and Maintenance 8 1 Processing and Cleaning Instructions Discard all contaminated parts after any suctioning procedure These components may include the collection canister and all suction tubing 2 Wipe the surface of the unit clean with a mild antiseptic such as Isopropyl alcohol and a clean soft cloth Do not allow cleaning solution to spill onto the unit itself Washing and Showering A CAUTION DO NOT use the MoblVac while washing or near water DO NOT submerge Disconnect the t
36. ubing from the MoblVac therapy unit before showering or washing to avoid damage to the unit o The clear dressing which covers the wound is water resistant but you should avoid submerging the dressing water Reconnect the tubing to the MoblVac unit as soon as you have finished washing and turn on the unit per the instructions below Refer to Operating the MoblVac 8 2 Battery Air Filter Replacement The MoblVac uses a type of battery called a lead acid battery This type of battery needs to be cycled on a regular basis Batteries of this type if they are unused for a certain period of time may lose their electrical potential and thereby have a diminished capacity and performance 1176097A Care and Maintenance Battery Door f your MoblVac pump is not operating properly flickering screen not powering or not holding a charge this may be a sign that the battery is no longer working properly The battery would need to be changed using Part Number 769721 Battery Replacement Kit as per the instructions below Remove the four Phillips head screws from the rear of the unit Remove the battery door in order to access battery and air filter Disconnect the wires from the two battery terminals When disconnecting pull the clips on the terminal not the wires themselves Remove the black air filter from the well next to the battery compartment 21 MoblVac Wound Care Pump
37. ure that the proper course of treatment is being followed See Contraindications and Precautions Use a contact dressing layer to completely cover any exposed tendons ligaments blood vessels organs any exposed bowel nerves and suture lines Completely cover and protect prior to application of NPWT The product is not to be used in a draining fistula site non enteric fistula or unexplored wound Use of the product under such circumstances may cause excessive bleeding 1176097A Safety CAUTION When dressing the wound ensure that the gauze is properly saturated with normal saline before sealing the wound When dressing the wound ensure that the moistened gauze does not extend to the healthy periwound tissue Do not use the pump in Magnetic Resonance Imaging MRI Computed Tomography CT Scanning Electrocardiogram EKG or ECG or in Hyperbaric Oxygen HBO therapy Disconnect the pump from the patient leaving the dressing intact while these therapies are in use 1176097A 7 MoblVac Wound Care Pump 3 Clinical Considerations Guidelines 3 1 Indications Contraindications Risk Factors The MoblVac NPWT pump is an AC DC powered portable aspirator that provides negative pressure for the application of wound drainage Negative Pressure Wound Therapy has been used with many types of wounds including 7 e pressure ulcers e chronic wounds e acute wounds e surgical wounds e
38. y are open Obstruction in extension or drain Disconnect extension and drain tubing ensuring the clamp on tubing extension tube is open Observe that the pump begins to run and using a gloved finger check for the presence of vacuum at the tubing connector If no vacuum is present replace extension tubing Obstruction in canister connection Remove the extension tubing from the canister and using a gloved finger check for the presence of vacuum If no vacuum is present replace canister Defective unit Call MoblVac Clinical Technical Hotline at 866 985 NPWT 6798 for assistance 1176097A 27 MoblVac Wound Care Pump Lockout Mode Lockout In order to utilize the lockout mode press the OPTIONS button from the vacuum level screen Press the LOCKOUT button The operator will notice the lock icon appears next to the battery level indicator All of the buttons on the unit are now disabled To unlock the unit press and hold the HOLD TO UNLOCK button then press the flashing UNLOCK button The buttons are now enabled Once the final selection is made the user can then press the RETURN button to return to the vacuum level screen l Screen flickers unit does not Battery is no longer working properly Replace battery by following instructions in section 8 2 power on or unit does not hold a charge 28 1176097A 10 Patient Caregiver Information 10 1 Patient Caregiver Training
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