6700032M User`s Manual
Contents
1. tube from the Canister to the SUCTION connector on the top front of the Therapy Unit see Figure 6 5 Insert the Sensing tube from the Canister to the SENSING connector on the top front of the Therapy Unit see Figure 6 The metal tabs on the connectors may need to be depressed to permit tube insertion Suction Tube Suction Port Sensing Tube D Sensing Port Rev I 7 09 SVEDMAN System User s Manual 3 3 Patient Care 6 Plug the therapy unit s A C Adapter into a suitable 120 VAC 60 Hz 3 prong outlet Insert the power plug into the Power Jack on the side of the Therapy Unit see Figure 7 Gently rotate clockwise to lock in place 7 Verify the dressing application is correct the tubing is connected the Dressing Suction Tube clamp is open and the Dressing Irrigation Tube clamp is closed 8 Begin therapy see OPERATING INSTRUCTIONS CANISTER REMOVAL 1 Press the OFF button to turn the therapy off 2 Close both tubing clamps engaged 3 Remove all tubing connectors from top of canister 4 Lift canister straight up and out of therapy unit 5 Dispose of canister according to local state and federal regulations as well as institutional protocols DRESSING REMOVAL Carefully read the SAFETY TIPS in the INTRODUCTION section of this guide prior to removing the dressing NOTE Wounds must be carefully monitored at regular intervals In a non infected wound dressings should be changed every 482. Disposable Canister with Gel 1 200 cc 10 per case cece eeeeeeeeeee ee ees 47 3000 Accessories SpeedConnect Tybine 2 20creasianahasaceretensschoseessanesamereighersasannnesters 47 2000 SVAMP Y Connect asirios rnn aE EE E E EEREN ER E E eee 47 2500 Polyurethane Drape 10 per PKS coccisccicadsdescacacssiinacscascecesiidedavcneeaase 47 7000 NOTE In order to assure the highest safety quality and efficacy of the products the SVEDMAN Wound Treatment System should only be used with Innovative Therapies Inc s disposables and Svamp Dressings should only be used with the SVEDMAN Wound Treatment Units Rev I 7 09 SVEDMAN System User s Manual 6 1 Replacement Parts T QUESTIONS amp INFORMATION For additional information pertaining to the SVEDMAN Wound Treatment System please contact your local ITI representative or ITI Innovative Therapies Inc We re all about the patient Innovative Therapies Inc 12 Meem Avenue Suite C Gaithersburg MD 20877 1 866 ITI NPWT 484 6798 www ITINPWT com For questions or comments regarding the content of this User s Manual please contact Innovative Therapies Inc ITD at the above address Please contact ITI Customer Service at 1 866 ITI NPWT 484 6798 for issues concerning the product and its use Duoderm is a trademark of Convatec All other trademarks designated herein are the property of ITI This product is covered by one or more
3. The solution to be used for wound irrigation should be appropriate for topical applications see SVEDMAN Wound Treatment System Indications and Precautions for more information on the suggested types of aqueous wound therapy solutions Make sure that the clamp on the Irrigation Tube remains closed until therapy is started 15 When irrigation is discontinued for example while changing the fluid reservoir place the Tubing Cap on the irrigation side of the SpeedConnect tube 16 Proceed to the therapy unit instructions to apply negative pressure wound therapy with irrigation RevI 7 09 SVEDMAN System User s Manual 3 2 Patient Care CANISTER INSTALLATION 1 Ensure that an ITI Fluid Collection Canister is properly placed in the receptacle located at the front of the therapy unit see Fig 4 NOTE Always use a new canister with a new patient Sensing Suction Tube Tuho Fluid collection canister Therapy Unit Patient Port Fig 4 Top of Collection Canister Fig 5 2 Inspect the SpeedConnect Tube flanges to ensure that they are properly connected to the Svamp Dressing and that the connections are well sealed 3 Connect the distal end of the SpeedConnect Tube with the blue tapered connector to the Patient port of the Canister see Figure 5 Gently twist and push the connector on just enough to secure and seal it Also make sure that the clamp on the SpeedConnect Tube is open 4 Insert the Suction
4. contaminated These include e The Svamp Dressing drape tubing and connectors e The exudate collection canister e Suction and irrigation tubing connectors amp clamps Dispose of all disposable components in accordance with local state and federal regulations and institution protocols NOTE Cleaning procedures should not be performed when unit is connected to a patient Disconnect the unit from the patient and power source before cleaning or servicing RevI 7 09 SVEDMAN System User s Manual 2 1 Care amp Cleaning DAILY CARE AND CLEANING Perform a visual inspection of the unit Check for any sign of contamination and ensure that the unit is functioning properly If the unit is not operating properly refer to the Alarm Troubleshooting guide in the OPERATING INSTRUCTIONS section of this manual or contact ITI to have the unit serviced If there are visible signs of contamination or the unit appears dirty follow the WEEKLY CARE AND CLEANING instructions below 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 SVEDMAN Wound Treatment Unit 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
5. internal battery is charging The therapy unit will continue to operate properly while charging is taking place Average Battery Life RevI 7 09 SVEDMAN System User s Manual 4 3 Operating Instructions The specified battery life of the SVEDMAN Wound Treatment Unit with a fully charged battery is approximately 12 hours The actual life is dependant on the integrity of the dressing A leak in the dressing can reduce overall battery longevity significantly Average Time for Recharging To ensure the battery has been fully charged the unit should be connected to an A C supply for approximately 3 hours After approximately 2 hours of charging the unit will have achieved 80 of total battery capacity Low Battery Alarm While running on battery a low battery alarm will chirp every 10 seconds and the OFF button will begin flashing when remaining capacity of the battery is less than 20 Typically the unit will continue to operate for approximately 1 hour after the low battery alarm is activated Low Battery Shutoff If the battery charge falls below a critical level the unit will shutoff automatically and therapy will be discontinued At this point the unit 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 unit Recharging the Battery Plug the power cord from the A C Adapter into the power receptacle on the side of the therapy uni
6. pending patents Copyright 2009 Innovative Therapies Inc All Rights Reserved Worldwide 07 09 P N 6700032M Rev I Rev I 7 09 SVEDMAN System User s Manual 7 1 Questions amp Information
7. will begin flashing when remaining capacity of the battery is less than 20 TherapyGuard Automated alarms for leak low pressure and full canister Alarms provide both a visual and audible indication Alarms will self reset once a problem is corrected or can be manually reset by turning the therapy unit OFF and ON SafetyGuard A unique non Luer Lock connector is provided for irrigation therapy that will not permit an accidental connection to a patient s I V line Integrated I V Pole Clamp amp Bed Hangers Pole clamp permits the unit to be mounted to a wide range of standard I V poles 0 9 to 2 2 2 to 5 0 cm in diameter Integrated stowable bed hangers permit the unit to be hung from a wide range of hospital bed foot boards SpeedConnect Six foot dual lumen tubing set with adhesive flanges to permit easy connection to dressing Single Patient Use Canister Large volume 1 200 cc canister for irrigation and highly exudating wounds CAUTION 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 Rugged Enclosure The SVEDMAN Wound Treatment System device is enclosed in an aluminum case to help prevent damage from drops and impacts RevI 7 09 SVEDMAN System User s Manual 1 4 Introduction Light Weight T
8. F The ON and OFF buttons are located on the left side of the control panel The ON and OFF buttons control the application of power to the therapy unit Low Pressure Leak Canister full 7OmmHg On 1 120mmHg Off 0 150mmHg POWER UP PROCEDURE 1 Verify the dressing application is correct the tubing is connected the Dressing Suction Tube clamp is open and the Dressing Irrigation Tube clamp is closed 2 Place the therapy unit in an upright position as level with the wound as possible The device can be placed on a table hung from a footboard using the integrated bed hangars or attached to an I V pole using the integrated I V pole clamp Rev I 7 09 SVEDMAN System User s Manual 4 1 Operating Instructions 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 unit 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 unit cannot slide down the pole 3 Hang I V bag on the I V pole at a level that is higher than the level of the wound 4 Press the ON button All LED indicators will illuminate for 1 second during the power on self test after which the ON button will steadily light green 5 Dressing should collapse indicating the presence of vacuum Once dressing integrity is veri
9. NTS INTRODUCTION Indications Contraindications Precautions Additional Precautions Safety Tips Features CARE amp CLEANING Introduction Protective Equipment Disposal Daily Care and Cleaning Weekly Care and Cleaning PATIENT CARE Applying the Dressing Canister Installation Canister Removal Dressing Removal Disposal of Dressings and Canister OPERATING INSTRUCTIONS Power ON OFF Power Up Procedure Therapy Setting Adjustment Battery Operation Alarm Operation Therapy Selection Lock Unlock SPECIFICATIONS Symbols REPLACEMENT PARTS QUESTIONS amp INFORMATION RevI 7 09 SVEDMAN System User s Manual ii 1 1 1 1 1 1 1 1 1 1 1 2 1 4 2 1 2 1 2 1 2 1 2 2 2 2 3 1 3 1 3 3 3 4 3 4 3 5 4 1 4 1 4 1 4 2 4 3 4 5 4 6 5 1 5 2 6 1 7 1 1 INTRODUCTION INDICATIONS The SVEDMAN Wound Treatment System is indicated for patients who would benefit from vacuum assisted drainage with delivery of topical wound treatment solutions and suspensions over the wound bed Types of wounds for which the SVEDMAN Wound Treatment System has been indicated include chronic acute traumatic subacute and dehisced wounds diabetic ulcers pressure ulcers flaps and grafts CONTRAINDICATIONS The SVEDMAN Wound Treatment System is contraindicated for patients with malignancy in the wound untreated osteomyelitis non enteric and unexplored fistulas or necrotic tissue with eschar pr
10. The SVEDMAN Wound Treatment Unit 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 Other cleaning fluids are not recommended as they may damage the finish of the enclosure A C ADAPTER INSPECTION The A C Adapter should be inspected regularly for damage and or unusual wear Replace damaged or worn Power Supplies immediately A C Adapters are available from ITI WARNING The SVEDMAN Wound Treatment Unit 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 WARNING Avoid spilling liquid on any part of the therapy unit Liquids can cause corrosion when left on electronic controls which can lead to failure Component failure may cause the therapy unit to operate erratically possibly causing a potential hazard to the patient or Caregiver RevI 7 09 SVEDMAN System User s Manual 2 2 Care amp Cleaning 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 RevI 7 09 SVEDMAN System User s Manual 2 3 C
11. Wound Care Anywhere Svedman Wound Treatment System User Manual CAUTION This SVEDMAN Wound Treatment System User s Manual is not a guarantee or warranty Itis intended only as an operational guide For additional information and questions please contact Innovative Therapies Inc s ITT Customer Service department at 1 866 ITI NPWT 484 6798 In order for the SVEDMAN Wound Treatment System 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 All assembly operation adjustment modification maintenance and or repair must be carried out only by qualified personnel authorized by ITI e The electrical installation of the room in which the device will be used must comply with applicable wiring standards and electrical codes e The product must be used in accordance with this manual and all associated labeling and the Instructions for Use 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 RevI 7 09 SVEDMAN System User s Manual i TABLE OF CONTE
12. are amp Cleaning 3 PATIENT CARE It is recommended that all sections of this manual be reviewed prior to using the product Carefully read the INDICATIONS CONTRAINDICATIONS PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to perform patient care for a patient with the SVEDMAN Wound Treatment System APPLYING THE DRESSING 1 Cleanse wound according to institution protocols or physician order 2 Debride all necrotic tissue including eschar and hardened slough 3 Becertain the wound has achieved hemostasis 4 Visually examine and palpate wound bed to locate any blood vessels or delicate underlying structure in close proximity 5 Irrigate wound with normal saline or solution per physician order 6 Prepare area around wound to permit adhesion of the polyurethane drape NOTE f 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 Duoderm Cut the drape to a size large enough to go over the foam and the barrier layer only 7 Take measurements of the wound dimensions and note pathology Cut the Svamp Dressing to a size that is appropriate for the wound NOTE Do not trim the dressing over or around the wound site to help prevent debris from the dressing from falling into the wound 8 Place the Svamp Dressing in the wound site taking care t
13. e throat with swelling of the mucous membrane disorientation high fever gt 102 F 38 8 C refractory hypotension orthostatic hypotension or erythroderma a sunburn like rash may be added signs of more serious complications of infection WARNING Do not pack the Svamp Dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols RevI 7 09 SVEDMAN System User s Manual 1 3 Introduction FEATURES Easy to use One Touch Operation Therapy can be activated simply with the push of a single button Therapy level can be quickly changed by pressing one of three buttons 70 mmHg 120 mmHg and 150 mmHg Therapy settings can be locked by the caregiver see Therapy Selection Lock Unlock Section Lighted membrane switches clearly indicate current setting to caregiver Intermittent Mode The SVEDMAN Wound Treatment System can be set to operate intermittently 5 minute 2 minute cycle Unit maintains 25 mmHg vacuum during the off state to prevent loss of dressing seal and increase patient comfort NoiseGuard Unit is virtually silent in its normal operation increasing patient comfort and compliance PowerGuard An internal battery provides approximately 12 hours of operation from a single full charge Battery charges while unit is operating with the AC adapter While running on battery a low battery alarm will chirp and the OFF button
14. esent Do not place the Svamp Dressing over exposed blood vessels or organs The Svamp Dressings are also contraindicated for hydrogen peroxide and solutions which are alcohol based or contain alcohol It is not recommended to deliver fluids to the thoracic cavity PRECAUTIONS Precautions should be taken for patients with active bleeding difficult wound hemostasis or who are on anticoagulants When placing the Svamp Dressing in close proximity to blood vessels or organs take care to ensure that they are adequately protected with overlying fascia tissue or other protective barriers Exposed tendon nerves or blood vessels should be protected by moving available muscle or fascia over them or by a layer of synthetic material Greater care should be taken with respect to weakened irradiated or sutured blood vessels or organs Bone fragments or sharp edges could puncture a dressing barrier vessel or organ Wounds with enteric fistula require special precautions in order to optimize therapy ADDITIONAL PRECAUTIONS e Defibrillation Remove the Svamp 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 e Magnetic Resonance Imaging MRI The SVEDMAN Wound Treatment Unit is not MRI compatible Do not take into the MRI area e Large Canisters Use of Large Canisters gt 500ml may increase serious risks associated wi
15. essing any other therapy level will result in three beeps with no change in setting This therapeutic setting will be recalled each time the unit is powered OFF and ON and the unit will remain locked until it is subsequently unlocked by the caregiver Unlocking To unlock the unit press and hold the selected therapy button the lit button until three audible beeps are heard At this point the unit is unlocked and therapy settings can be changed Additionally when the unit is powered OFF and ON the unit will remain unlocked and will automatically revert to the default setting of 120 mmHg RevI 7 09 SVEDMAN System User s Manual 4 6 Operating Instructions SPECIFICATIONS SVEDMAN Wound Treatment System Dimensions iare aaa Aa RE R REES 13 5 x 7 x 10 5 in 34 29 x 17 78 x 26 67 cm Welshtt esre RE nu a E E EE S E E 5 5 Lbs 2 495 g Therapy Settings en EE E E EEVEE TE ERSTES 70 120 amp 150 mmHg Canister Volume seisis E A A SEN E E E dered wed UR ESS 1 200 cc lke C US Medical Equipment with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 IEC60601 1 EN60601 1 and CAN CSA C22 2 No 601 1 IEC Classification Medical Equipment Equipment not suitable for use in presence of flammable anesthetic mixture with air oxygen or nitrous oxide Continuous Operation Type B Applied Part Class II Internally Powered Equipment IPXO Battery Duration Fully Charged 0 00 ccceceeeeeee
16. fied open the Dressing Irrigation Tube and adjust drip to a rate appropriate for desired therapy 6 Carefully check dressing for vacuum or fluid leaks and repair with additional Polyurethane drape material as needed 7 The SVEDMAN Wound Treatment System should be operated at least 22 hours out of every 24 hour period Remove the Svamp Dressing if irrigation therapy is terminated or is off for more than 2 hours in a 24 hour period THERAPY SETTING ADJUSTMENT CAUTION Only a physician can prescribe the proper settings and irrigation protocols for the therapy unit Failure to follow product instructions or adjusting settings and performing therapy application without the express direction and or supervision of your trained caregiver may lead to improper product performance and the potential for serious or fatal injury RevI 7 09 SVEDMAN System User s Manual 4 2 Operating Instructions Negative Pressure Level Adjustment There are three settings of negative pressure that can be selected 70 mmHg 120 mmHg and 150 mmHg The negative pressure selector buttons are located on the right side of the control panel Use these buttons to select the therapy setting that is appropriate for the patient 1 When the unit is powered up the default setting of 120 mmHg is automatically selected unless therapy setting has been locked previously by caregiver see Therapy Selection Lock Unlock Section 2 To change the setting simpl
17. he therapy unit weighs only 5 5 Lbs 2 495 g and can be easily carried and transported Long life Pump Diaphragm type pump with brushless motor increases life expectancy of the unit and minimizes maintenance requirement RevI 7 09 SVEDMAN System User s Manual 1 5 Introduction 2 CARE amp CLEANING INTRODUCTION The following instructions are the Innovative Therapies Inc ITI recommended daily and weekly cleaning and infection control procedures for the SVEDMAN Wound Treatment System The Caregiver should review this manual in its entirety before attempting to the use the product Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to perform cleaning procedures on the SVEDMAN Wound Treatment Unit PROTECTIVE EQUIPMENT Universal Safety Precautions should be used to minimize the risk of infection and contact with contaminated blood or bodily fluids during the dressing changes or disposal it is important to protect all exposed skin and mucous membranes The protective equipment includes 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 DISPOSAL After patient use all disposable components of the system should be treated as
18. ipment 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 After patient use all disposable components of the system should be treated as contaminated These include e The Svamp Dressing and 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 RevI 7 09 SVEDMAN System User s Manual 3 5 Patient Care 4 OPERATING INSTRUCTIONS This section contains instructions for setting and adjusting functions of the SVEDMAN Wound Treatment Unit The section explains the procedure for activating therapy and explains the major functions that are adjusted from the control panel Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to operate and adjust the SVEDMAN Wound Treatment Unit WARNING The SVEDMAN Wound Treatment Unit should only be used with the supplied A C Adapter Use of an incorrectly rated adapter could create a shock hazard for the patient or caregiver The part number for the adapter can be found in the REPLACEMENT PARTS section of this manual POWER ON OF
19. neeeeeeeeenteee een eeeeeneeeeneeanes approximately 12 hours Electrical External Power Supply Input e cece ee eeeeee eee eeaeen ees 100 240 VAC 50 60Hz 700 mA External Power Supply Output 0 cece cece eee ee ne eee eeaeeeneeneenes 15 VDC 2 Amps Patient amp Enclosure leakage Current 02 cc eceec ence cence neee eae esuseeeaenaeas lt 100 Microamps Environmental Conditions Storage Conditions Temperature Range cccccccc cece nee eee ee ee ee eeee eens EEE 10 F 12 C to 110 F 43 C Relative Humidity Range 0 ccc cce eee cence eee ee eee eee eneeeeee eas 20 95 Non condensing Atmospheric Pressure Range ccccceceeee ee eeeeneee eens ene ee eee eauneeneegees 50 kPa to 110 kPa Operating Conditions Temperature Range ccc cece tsn ec ee eee ee cece ee eeeen ea eeea seen enenees 40 F 4 C to 90 F 32 C Relative Humidity Range c cece ese e cece eceeceeeee ee eeeeeeenaeaees 20 75 Non condensing Atmospheric Pressure Range ccceceeceeeeeeeeneeeeeeeeaeeeaeneeeeeeaeeenens 50 kPa to 110 kPa Expected useful life of SVEDMAN Wound Treatment Unit 0 0 eee 3 years CAUTION Federal law restricts this device to sale by or on the order of a physician Specifications subject to change without notice Rev I 7 09 SVEDMAN System User s Manual 5 1 Specifications EXPLANATION OF SYMBOLS DEVICE Refer to User I
20. nstructions nS Alternating Current Not protected against E Class Il Internally IPXO harmful effects of Powered Equipment water Kk Type B Applied Part DRESSINGS N Refer to User Instructions Fragile ae at od Sterilization Keep Dry STERILE EO Method of Sterilization Ethylene Oxides Single Use Only Dd Expiry Date Date of Manufacture Directive 93 42 EEC and has been subject to the conformity procedures laid down O Lot Batch Number in the council directive Conforms with the Medical Device 3 B m A 15 30 C or R s9 86F Storage Conditions Rev I 7 09 SVEDMAN System User s Manual 5 2 Specifications 6 REPLACEMENT PARTS Description Part Number Therapy Unit SVEDMAN Wound Treatment Unit 00 c cece cece ee ceeeceeee onan ee ens 6700032 SVEDMAN User s Mana ccc lt csarciaceeasancessdeneasenrssoacacesanneseacnes 6700032M A C Power Adapter FRIWO Model FW73602M 15 ogi sets esses i teenies E i 47 9000 Dressings SVAMP Small Foam Dressing Set 10 per case 0 eeeeeeeeeeetee ee eens 47 1702 SVAMP Medium Foam Dressing Set 10 per case cceeeeeeetee eee eee 47 1701 SVAMP Large Foam Dressing Set 10 per case ceeeeeee eee eee e eters 47 1700 SVAMP X Large Foam Dressing Set 10 per case cceeeee eee e neces 47 1703 VIT Foam Dressing 10 per Case icscextakincessasiss sevesagaterianeeanwieseeieien 47 1751 Canisters
21. ntroduction UNSTABLE STRUCTURES Over unstable body structures such as unstable chest wall or non intact fascia use the lowest pressure setting on the SVEDMAN Wound Treatment Unit SPINAL CORD INJURY In the event a patient experiences autonomic hyperreflexia sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system discontinue use of the SVEDMAN Wound Treatment System to help minimize sensory stimulation BODY CAVITY WOUNDS Underlying structures must be covered by natural tissues or synthetic materials that form a complete barrier between the underlying structures and the Svamp Dressing Svamp DRESSING USE The Svamp Dressings distributed by Innovative Therapies Inc are to be used exclusively with the SVEDMAN Wound Treatment System NOTE All dressing components of the SVEDMAN Wound Treatment System are packaged sterile The decision to use clean versus sterile aseptic technique is dependent upon wound pathophysiology and physician clinician preference All components of the SVEDMAN Wound Treatment System disposable set are latex free Be sure to comply with all other CONTRAINDICATIONS and PRECAUTIONS for the SVEDMAN Wound Treatment System Signs of possible infection may include fever tenderness redness swelling itching rash increased warmth in the wound area purulent discharge or a strong odor Nausea vomiting diarrhea headache dizziness fainting sor
22. o avoid contact with the peri wound tissue WARNING Do not pack the Svamp Dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols NOTE The Svamp should cover the entire wound margin including tunneling and undermining However the Svamp should not be in contact with intact skin RevI 7 09 SVEDMAN System User s Manual 3 1 Patient Care 9 Size and trim the Polyurethane Drape to cover dressing plus a 3 5 cm border of intact skin Save the extra drape for later use if needed Remove the drape s release liner and place over the Svamp and peri wound 10 Pat drape material down around the wound site and over the Svamp Dressing to ensure dressing is properly sealed 11 Cut two 1 cm diameter holes in the top of the drape at both ends of the dressing see Fig 1 12 Peel the backing from one of the SpeedConnect flanges and place it above one of the holes made in Step 11 Using the tips of the fingers press around the top of the SpeedConnect to ensure a good seal to the dressing see Fig 2 13 Repeat Step 12 for the second SpeedConnect flange see Fig 3 g To Fluid Collection To Fluid Collection Canister Canister 9 K nE Pi IV Set lt O SVAMP SS Dressing ee Polyurethane Drape Material Fig 1 Fig 2 Fig 3 14 Connect the irrigation side of the SpeedConnect tube with SafetyGuard to the wound Irrigation Set NOTE
23. t Rotate the connector clockwise to lock in place Plug the A C Adapter into a suitable 120 VAC 60 Hz wall outlet When the unit is connected to an AC power source the GREEN LED above the power receptacle will illuminate indicating AC power is present and the AMBER LED will illuminate when the battery is charging Once the battery is fully charged the AMBER LED will extinguish indicating the charge cycle is complete When the SVEDMAN Wound Treatment Unit is disconnected from the AC power source the device will automatically switch over to the internal battery and continue to operate without interruption RevI 7 09 SVEDMAN System User s Manual 4 4 Operating Instructions ALARM OPERATION Clearing an Alarm Condition To clear an alarm condition turn the therapy unit OFF then ON The alarm will clear when the power is cycled Alarm Troubleshooting ALARM TYPE INDICATION CORRECTIVE ACTION CANISTER IS FULL Canister Full LED lights accompanied by an intermittent audible alarm Unit will continue to alarm until the canister is replaced Turn unit off by pressing the OFF button Remove canister and replace as necessary Press the ON button to resume therapy If conditions persist refer unit for servicing as the alarm may indicate an internal problem LOW PRESSURE Low Pressure Leak LED lights Check all tubing connections DRESSING LEAKS accompanied by an intermittent between the therap
24. th 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 e The SVEDMAN Wound Treatment System is intended for use with saline solutions in a physiologic pH range that can optionally include topical wound treatment solutions RevI 7 09 SVEDMAN System User s Manual 1 1 Introduction e Various topical agents such as hydrogen peroxide are not intended for extended tissue contact If in doubt about the appropriateness of using a solution with the SVEDMAN Wound Treatment System contact the solution s manufacturer e Do not apply solutions in conflict with the manufacturer s instructions for use e During irrigation therapy the Svamp Dressing is a closed system and is NOT vented to atmosphere e Do not use where temperature of fluid could cause an adverse reaction such as a change in patient s core body temperature e During irrigation therapy the IV bag should be checked periodically to ensure proper fluid delivery In addition when a canister fills with fluid it should be replaced immediately as irrigation fluid and wound exudate will not be removed from the dressing once the canister is full SAFETY TIPS KEEP THERAPY ON The SVEDMAN Wound Treatment System should be operated at least 22 hours out of every 24 hour period Remove the Svamp Dressing if irrigation therapy is terminated or is off for more
25. 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 then 48 72 hours Always replace with sterile disposables from unopened packages Follow established institution protocols regarding clean versus sterile technique MONITORING THE WOUND Inspect the dressing frequently to ensure that the foam is collapsed and that therapy is being delivered in a consistent manner Monitor 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 SVEDMAN Wound Treatment System infection can lead to many adverse complications including pain discomfort fever gangrene toxic shock septic shock and various other complications With signs of more serious complications of infection discontinue use of the SVEDMAN Wound Treatment System until the serious infection is diagnosed and properly treated DISCOMFORT ADHERENCE If patient complains of discomfort during dressing change consider pre medication use of a non adherent prior to foam placement or irrigation of a topical anesthetic agent such as 1 Lidocaine prior to dressing removal RevI 7 09 SVEDMAN System User s Manual 1 2 I
26. to 72 hours but no less than 3 times per week with the frequency of dressing change determined by the clinician Infected wounds must be monitored continuously For infected wounds dressings may need to be changed more often than 48 72 hours the dressing change interval should be based on a clinical evaluation of the wound condition rather than a fixed schedule NOTE The Canister should be replaced when full the Canister Full alarm activates or at least once every week to minimize the potential for contamination and production of odors 1 Press the OFF button to turn the therapy off 2 Close both tubing clamps engaged 3 Disconnect SpeedConnect Suction and Irrigation tubes Twisting the tapered connector will make removing the Suction tube from the Canister easier RevI 7 09 SVEDMAN System User s Manual 3 4 Patient Care 4 Slowly pull drape up and away from skin while gently stretching drape NOTE Ifthe Svamp Dressing adheres to the wound during removal refer to the SAFETY TIPS section of this manual 5 Discard disposables in accordance with applicable rules regulations and infection control protocols and always follow Universal Safety Precautions 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 equ
27. y press the desired setting button 3 The setting button will flash indicating the selection has been made and will continue flashing until the desired negative pressure level has been achieved at which time the button will stay illuminated Intermittent Mode ON OFF S W Ver 2 57 amp Higher The SVEDMAN can operate in an intermittent suction mode with a 5 minute on and 2 minute off cycle To turn the intermittent mode on press and hold the desired setting button then momentarily press the OFF 0 button The unit will beep and the green ON 1 button will begin flashing indicating the unit is now operating in intermittent mode Release both buttons To turn the intermittent mode off and return the device to the default continuous mode repeat the above steps The unit will produce a single long beep and the green ON 1 button will steadily illuminate The SVEDMAN will remember the mode setting when the power is turned OFF and ON During intermittent operation the SVEDMAN will provide target therapy pressure throughout the on part of the cycle and approximately 25 mmHg throughout the off part of the cycle By maintaining this lower pressure while the unit is off the dressing seal is never compromised This method of applying intermittent pressure also increases patient comfort BATTERY OPERATION NOTE The SVEDMAN Wound Treatment System is designed to permit use of the product while the
28. y unit and audible alarm Dressing Unit will continue to alarm until Check the security of the the low pressure leak condition is canister s lid and drain plug corrected or the alarm is cleared Check for cracks in the canister Pat around drape to check for leaks If leak is found patch with extra drape material LOW BATTERY The OFF button will flash on and Utilizing an approved ITI A C off accompanied by an intermittent audible chirp every 10 seconds The unit will continue to alarm until connected to an A C power source When the charge falls below a critical level the therapy will be discontinued Adapter connect unit to an A C power source to provide operating power and to recharge the internal battery NOTE In the event of an emergency please contact your treating physician caregiver or your local emergency responders NOTE If an Alarm Condition persists and cannot be resolved please contact ITI for further assistance RevI 7 09 SVEDMAN System User s Manual 4 5 Operating Instructions THERAPY SELECTION LOCK UNLOCK The SVEDMAN Wound Treatment Unit is equipped with a therapy locking feature designed to prevent unauthorized individuals from changing the therapeutic settings inadvertently Locking To lock the unit press and hold the desired therapy level 70 120 150 mmHg for three seconds until three audible beeps are heard At this point the unit is locked Pr
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