M6252203 (D) VAC ATS USER MANUAL
Contents
1. Always follow Recommended Safety Precautions and use universal precautions Inspect Power Cord Regularly The power cord should be inspected regularly for damage and wear Replace damaged or worn power cords immediately Power cords are available from KCI Cleaning Surface of the Therapy unit The V A C ATS unit should be wiped weekly with either a diluted solution of bleach 50ml in 5 liters or mild disinfectant The cloth should be damp not dripping to avoid getting excess fluid anywhere on the therapy unit Other chemicals should not be used as they may damage the V A C ATS unit enclosure NOTE Patient does not typically need to be removed from the V A C ATS when performing weekly cleaning procedures If the therapy unit is being cleaned when therapy is being applied to a patient it 1s important to disable the touchscreen to ensure that no inadvertent commands take place Utilities To disable the touchscreen 1 Press the Exit button on each screen until the Home Screen 1s displayed 2 Press Utilities 3 Press the button marked 5 Z T Cleaning to enter the Cleaning Screen that automatically hn O 0 mmHg disables the main areas of the Continuous touchscreen UTILITIES SCREEN CAUTION The electrical telephone style connector inside the canister housing is for KCI service use only Care should be taken when cleaning to ensure that no fluid enters this connector SKCI k CARE AND CLEANING co2. Pat around drape to check for leaks If leak is identified patch the leak with extra drape Visual message with a dible prompt after 2 minutes which TUBING AND OR cancels if leak is sealed DRESSING HAS LEAKS Ww Ensure T R A C connector After an additional 2 minutes a is properly locked full alarm 1s sounded and after 5 minutes therapy is turned off acne VAC ATS caier is fully engaged Visual message accompanied by audible alarm after 15 minutes Turn Therapy ON with Therapy Off THERAPY IS NOT ACTIVATED Audible alarm accompanied by Connect therapy unit to a BATTERY IS LOW a visual message before shut Mains AC power source to down recharge the battery Silencing the Alarm Press the MUTE button on the alarm screen to silence the alarm for two minutes After correcting the alarm condition you can press the CONTINUE button to silence the alarm and return to the HOME screen l SKCI CARE AND CLEANING Protection Against Contamination To help reduce the risk of infection and contact with contaminated blood or body fluids during the dressing change or cleaning of equipment it is important to protect all exposed skin and mucous membranes Protective clothing includes e Disposable gloves e Disposable impervious gown if splashing of blood or body fluids is possible e Protective eyewear to help protect from splashing of cleaning solution and or blood or body fluids e Protective mask
3. Phone 1 888 275 4524 or 1 877 woundvac Fax 1 800 275 3417 www woundvac com CANADA Representative KCI Medical Canada Inc 7170 Edwards Blvd Mississauga Ontario L5S 1ZL Canada Phone 1 905 565 7187 Fax 1 905 565 7270 Outside USA amp Canada KCI International Inc 8023 Vantage Dr San Antonio TX 78230 USA Phone 1 210 255 6460 Fax 1 210 255 6991 www woundvac com Manufactured For Manufactured by and Corporate Headquarters EU Representative KCI USA INC KCI Medical Products UK Ltd 8023 Vantage Dr 11 Nimrod Way San Antonio TX 78230 USA Wimborne Dorset 1 877 WOUNDVAC BH21 7SH ENGLAND In case of emergency contact local emergency number or treating physician All trademarks and service marks designated herein are proprietary to KCI its affiliates and licensors Trademarks designated are registered in at least one country where this product is commercialized but not necessarily in all such countries The V A C Vacuum Assisted Closure system and certain components are subject to one or more of the following patents USA 4 969 880 5 100 396 5 261 893 5 527 293 5 636 643 5 645 081 6 071 267 6 135 116 6 142 982 EC EP0777504 EP0688189 EP0620720 EP0865304 EP0465601 EP1088569 other patents pending 2002 KCI All rights reserved 17
4. partial thickness burns diabetic ulcers pressure ulcers flaps and grafts Contraindications Contraindicated for patients with malignancy in the wound untreated osteomyelitis unexplored and non enteric fistulas or necrotic tissue with eschar present Do not place V A C dressing over exposed blood vessels or organs Precautions Always Follow Universal Precautions Precautions should be taken with patients exhibiting active bleeding difficult wound hemostasis or who are on anticoagulants When placing the V A C dressing in proximity to blood vessels or organs take care to ensure that they are adequately protected with overlying fascia tissue or other protective barriers that form a complete barrier between them and the V A C foam dressing Greater care should be taken with respect to weakened irradiated or sutured blood vessels or organs Bone fragments or sharp edges could puncture a barrier vessel or organ Wounds with enteric fistulas may require special precautions in order to optimize V A C Therapy Refer to the V A C Therapy Clinical Guidelines for sample guidelines additional information on clinical applications and therapy considerations For recommended protocols please consult the treating physician Federal law restricts this device to sale or rental by or on the order of a physician SKCI V A C THERAPY CARE AND SAFETY TIPS KEEP THERAPY ON Never leave subatmospheric pressure off for more than 2 hours
5. only be used on poles that are in excess of 2 2cm 9 diameter and are securely attached to a bed frame or a stable stand To ensure stability of the therapy unit on the IV pole it should be clamped no higher than 2 times the width of the pole base The clamp should be sufficiently tightened to ensure that the therapy unit cannot slide down the pole 3 Attach the power cord to the V A C ATS unit and connect to a suitable power supply 4 Turn on power to the therapy unit by pressing the green Power ON switch above the power cord amp KCI i OPERATING INSTRUCTIONS contd R aZ a ACTIVE SCREEN SE Acco 1 mmHe OE mo E E a m STATUS SCREEN HOME SCREEN 5 Press Therapy button to select Therapy Screen Therapy dom J A V Megative Pressure hn 000 mmHg Intermittent THERAPY SCREEN 6 Select level of negative pressure Use arrow keys to increase or decrease therapy levels between 50 and 200mmHg as per physician order The therapy unit 1s set at a standard negative pressure of 125mmHg i SKCI OPERATING INSTRUCTIONS contd 7 Select Continuous or Intermittent therapy The standard setting 1s Continuous therapy If you select Intermittent this will take you to the Intermittent Therapy screen The standard setting for intermittent therapy is 5 minutes on and 2 minutes off Intermittent Therapy Use the arrow keys to increase or N decrease On and Off time
6. 60 80 F CONDITIONS t Q WITH THE MEDICAL DEVICES DIRECTIVE 93 42 EEC 0473 EEC DIRECTIVE The KCI V A C ATS is in conformity with the Medical Device Directive 93 42 EEC and has been subject to the conformity assurance procedures laid down in the Council Directive KCI Medical Products UK Ltd is certified by AMTAC Certification Services Ltd as an approved medical device manufacturer The KCI V A C ATS conforms to the following International standards EN 60601 1 1 1990 including A13 1996 CAN CSA C22 2 No 601 1 M90 UL2601 1 1994 1 Edition Amended 1996 EN60601 1 2 1993 amp KCI i ORDERING INFORMATION AND CONTACT ADDRESSES Ordering Information V A C ATS 110v Therapy unit M8259968 V A C ATS 230v Therapy unit M8259967 T R A C System Small Black Foam Dressing 10 Carton M627505 1 10 T R A C System Medium Black Foam Dressing 10 Carton M6275052 10 T R A C System Large Black Foam Dressing 10 Carton M6275053 10 V A C ATS T R A C System Canister with Gel 10 Carton M6275063 10 Please contact your KCI representative for a full product catalogue Contact Addresses For location and contact information of KCI operations world wide visit the KCI website at www woundvac com For additional sales and technical information concerning the V A C ATS please contact your local KCI representative or USA Representative KCI USA Inc 8023 Vantage Dr San Antonio TX 78230 USA
7. ATS urren E E E b i 2 8 29 3u Eva di rm m i m 20 w nite gt SS The Clinical Advantage P N M6252203 REV F 8 12 03 Caution Federal law restricts this device to sale or rental by or on the order of a physician In order for KCI products to provide safe reliable and proper performance the following conditions must be adhered too Failure to comply with these conditions will void any applicable warranties e Assembly operations extensions re adjustments modifications or repairs are carried out by qualified personnel authorized by KCI e The electrical installation of the room complies with the appropriate national electrical wiring standards e The equipment is used in accordance with the accompanying documentation and applicable labelling e Technical maintenance for the product is performed by qualified personnel authorized by KCI Subject to confidentiality protections satisfactory to KCI KCI will make available upon request circuit wiring diagrams component part lists descriptions calibration instructions or other information which may assist the user s appropriately qualified personnel to repair those parts of the equipment designated by the manufacturer as repairable Although this equipment conforms to the intent of the directive 89 336 EEC in relation to Electromagnetic Compatibility all electrical equipment may produce interference If interference 1s suspected
8. apy unit controls or settings However it is important that other clinicians in your facility understand how to lock and unlock the screen before the feature is used The lockout feature is available from all screen menus example shown 1s the Utilities Screen Utilities hn 0 mmHg OFF Continuous To Lock Touchscreen Press the Lock symbol for 3 seconds to disable the touchscreen user controls The lock symbol will now be closed fl to indicate the touchscreen controls are locked To Unlock Touchscreen To unlock the controls press the lock symbol for 3 seconds The lock symbol will now be open B to indicate the controls are unlocked SKCI APPLYING THE DRESSING Pouch Contents Identification N YN J V A C FOAM T R A C PAD V A C DRAPE 1 Perform aggressive wound care per physician order prior to V A C Dressing application 2 Cut the V A C foam to fit the size and shape of the wound then place the foam a into the wound cavity Avoid cutting foam directly over wound to prevent particles from entering wound bed Warning do not pack the foam into any areas of the wound Forcing foam dressings in a compressed manner into any wound is contrary to KCI recommendations 3 Size the drape to cover the foam and 3 5 cm of surrounding intact skin Trim drape if necessary Remove the white backing liner labeled 1 and place drape on foam Remove top suppor
9. f Close clamps on canister and dressing tubing Twist T R A C Connector C to disconnect canister tubing from dressing tubing Press canister release button B then pull out the canister Dispose of canister according to hospital protocols AE a Additional canisters and dressings are available and can be ordered through your local KCI representative i SKCI DISPOSAL OF V A C ATS DRESSINGS AND CANISTERS Disposal of used V A C ATS dressings and canisters After patient use all disposable parts of the system should be treated as contaminated These include e All tubing and related connectors and clamps e Canister e V A C ATS dressing drape and related connector and tubing Hand and eye protection should be used when handling any body fluids or waste Properly dispose of all parts according to institutional procedures and local state and federal regulations Use universal precautions SKCI k ALARMS A visual alarm will be indicated on the screen followed by an audible alarm under the following conditions ALARM TYPE NOTIFICATION REMEDY Visual message accompanied by Change canister and restart CANISTER FULL audible alarm therapy Visual message with audible prompt which cancels after 1 minute if blockage is cleared Ensure tubing clamps are open PRENC AS EEEE Check that tubing is not After 5 minutes of blockage kinke or pinched therapy is turned off and full alarm is sounded
10. mittent Therapy essere 6 bran CY 9 6 DOC ROME FC HI CR 7 Applying the Dressing eee 8 Canister Installation amp Removal 9 Disposal of Used Dressings and Canisters 10 ICI Tro 11 CIPIELS NEU ENT IE Rc m 11 Tubinp 1s DIOC kedise uod O E A ER 11 Leak in tubing or dressing nH Ldsesesssssssserssssssssserrressssssrererssssssseeerres 11 Therapy not CUI RIP MG 11 LOW DAOI RERUMS T 11 Care and Cleaning ooi eii te ee rir EROHERERR 12 Battery Operation utor initonut hens DIES Mehr 14 Specifications 0 0 ccc ccc cece escescsecseescsecsecseeecsecsecseessecseeeeeeaes 15 Explanation of Symbols Used 16 Ordering Information ee 17 Contact addresses sse 17 ii V A C THERAPY CLINICAL APPLICATIONS Indications Indicated for patients who would benefit from a sub atmospheric pressure device particularly as the device may promote wound healing This includes patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and or intermittent sub atmospheric pressure Types of wounds for which V A C Therapy has been indicated include chronic acute traumatic sub acute and dehisced wounds
11. move equipment from sensitive devices or contact the manufacturer WARRANTY INFORMATION IN THE UNLIKELY EVENT OF A DEFECT IN MATERIALS OR WORKMANSHIP A LOCAL KCI OFFICE SUBSIDIARY OR AUTHORIZED AGENT WILL REPAIR REPLACE OR SUPPLY REPLACEMENT PARTS UNDER STANDARD WARRANTY TERMS AND CONDITIONS IN EFFECT AT TIME OF PURCHASE WARRANTY TERMS AND CONDITIONS ARE SUBJECT TO CHANGE AT ANYTIME WITHOUT NOTICE WARRANTY TERMS AND CONDITIONS ARE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL KCI BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES AND EXPENSES INCLUDING DAMAGES TO PROPERTY DUE IN WHOLE OR IN PART TO THE USE OF THE PRODUCT UNLESS OTHERWISE EXPRESSLY REQUIRED BY LAW IN THE EVENT OF DEFECT REPAIR WORK SHOULD BE COMPLETED BY RETURNING THE THERAPY UNIT TO A LOCAL KCI OFFICE SUBSIDIARY OR AUTHORIZED AGENT CONTACT KCI FOR YOUR NEAREST LOCATION TABLE OF CONTENTS Clinical Applications Indications Contraindications Precautions esee l V A C Therapy Care and Safety Tips 2 AUN reg a R E A E 3 Operating Instructions seen 4 Scetune p the VAC ATSCU D escono cas onsieacranenmudsnsssenceneeseedionsieudens 4 Selecting Level of Negative Pressure cccccccssssesssecececceeeeeeeseeeeeees 5 Continuous or Inter
12. ntd screen Cleaning IM 4 Wipe the screen with a clean dry cloth If necessary use a slightly damp cloth Wipe the screen carefully using a clean cloth and wipe dry 5 Follow the instructions on the screen to Da nat wash down or use running water exit back to the Home Screen Press 1 2 3 4 in turn to exit hn 0 mmHg OF F Continuous CLEANING SCREEN i SKCI BATTERY OPERATION Automatic switch to battery power The V A C ATS will automatically revert to battery operation if AC mains power is disconnected Therapy unit will operate at previous settings The plug icon will no longer appear on the screen and the battery icon will appear Once the V A C ATS is plugged back into the wall AC mains power is restored and the battery will automatically re charge while the therapy unit remains plugged in e Average battery time after full recharge approximately 4 hours depending on the settings e Average time to recharge battery approximately 4 hours fast charge to reach 85 capacity approximately 10 hours to reach full charge e Low battery alarm One tick mark within the battery indicator signals approximately 25 of battery time is left An audible alarm will sound when the battery is very low then the therapy unit will switch to Therapy OFF However the touchscreen will still remain functional at the time of a low battery alarm e Automatic shutdown If the battery charge falls below a critical level the therap
13. per day Remove V A C dressing if subatmospheric pressure is terminated or is off for more than 2 hours per day DRESSING CHANGES Perform aggressive wound cleaning per physician order prior to dressing application Routine dressing changes should occur every 48 hours Dressing changes for infected wounds should be accomplished every 12 24 hours Always replace with sterile disposables from unopened packages Follow established institution protocols regarding clean versus sterile technique Note All components of the V A C 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 V A C therapy disposables including the foam canister tubing and drape are latex free MONITORING THE WOUND Inspect the dressing frequently to ensure foam is collapsed and negative pressure 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 V A C therapy infection can lead to many adverse complications including pain discomfort fever gangrene toxic shock septic shock and various other complications IF DRESSING ADHERES TO WOUND Instill normal saline into the dressing and let it set for 15 30 minutes then gen
14. s swelling itching rash increased warmth in the wound area purulent discharge or a strong odor Nausea vomiting diarrhea headache sore throat with swelling of the mucous membrane disorientation high fever gt 102F 38 8 C refractory hypotension orthostatic hypotension or erythroderma a sunburn like rash may be added signs of more serious complications of infection amp KCI FEATURES e T R A C Technology T R A C Therapeutic Regulated Accurate Care Ability to accurately sense negative pressure applied at wound site This feature helps ensure that the target therapy pressure is maintained even during patient movement e 500ml Canister A large capacity canister with an integrated hydrophobic and charcoal filter provides bacteriological protection and significantly reduces odor from collected exudate e On Screen User Guide User help screens assist operation e Easy to Use Touch Screen Allows operator to more easily view and change V A C ATS therapy settings e Removable Power Cord Detachable power cord allows greater patient mobility and flexibility e Integrated Battery and Charger Provides up to 4 hours battery life An automatic charging facility switches to battery power when AC mains power is removed e Extended Pump Life Linear brushless pump with increased life expectancy e Intensity Setting The speed at which the target pressure setting 1s achieved can be varied in accordance with varying wo
15. s between 1 and 10 minutes in accordance with recommended physician guidelines Press exit to confirm selection and return to Therapy screen V OH minutes OFF minutes 0 mmHg Continuous 8 Select Intensity level The intensity level is the rate of negative pressure change at the wound site in mmHg per second The lower the intensity level the more gradual the negative pressure increases to the desired setting This option ts especially useful for patients who may experience pain and discomfort during initial pull down and release of the foam especially during intermittent therapy The Intensity option ranges from 10 to 50mmHsg sec in increments of 5 The standard setting is 10 It is recommended that new patients start therapy at the standard setting of 10 and increase gradually according to patient tolerance and needs The intensity can also remain at the minimum setting throughout the entire length of treatment to enhance patient comfort Intensity Use the arrow keys to increase or decrease More intense pressure change at the wound site in mmHg per second This should be adjusted in TO RUM accordance with varying wound conditions nm patient tolerance and at the direction of a physician hn 0 mmHg O F F Continuous Press Exit to return to the Therapy screen amp KCI OPERATING INSTRUCTIONS contd Lockout Feature This feature is most useful in preventing individuals from tampering with ther
16. t layer labeled 2 and pat around drape to ensure an occlusive seal 4 Choose a location on the drape where you would like to apply the tubing At this location cut a hole through the drape approximately 2 cm in diameter leaving the foam mostly intact An alternative is to cut a 2 cm diameter hole into the drape before you lay it down on the foam Either process of cutting the drape will work Note It is very important to cut a complete hole not a slit in the drape as a slit may not allow fluid passage through the drape resulting in a blockage alarm 5 Remove the backing liner labeled 1 from the T R A C Pad Place the T R A C Pad on the drape with the hole in the center of the T R A C Pad elbow directly over the hole in the drape Gently pat around the T R A C Pad to ensure complete adhesion Remove the support layer labeled 2 6 Remove the blue handles from the drape and T R A C Pad where applicable Connect dressing tubing to canister tubing 7 Refer to page 9 for canister installation SKCI CANISTER INSTALLATION AND REMOVAL Canister aC Dressing o C pd Canister Installation 1 Slide the canister into the canister port A until an audible click is heard ensuring that 1t 1s fully inserted 2 Connect the two halves of the T R A C M connector C Push and twist until it locks in place Verify that both clamps are open 4 Turn therapy ON p Canister Removal Turn therapy of
17. tly remove the dressing from the wound Consider placing a single layer wide meshed non adherent dressing prior to foam placement DISCOMFORT If patient complains of discomfort throughout therapy consider changing to white PVA Soft Foam If patient complains of discomfort during the dressing change consider pre medication use of a non adherent prior to foam placement or instillation of a topical anesthetic agent such as 1 lidocaine without epinephrine prior to dressing removal UNSTABLE STRUCTURES Over unstable body structures such as unstable chest wall or non intact fascia use continuous not intermittent therapy to minimize movement and stabilize the wound bed 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 V A C therapy 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 V A C foam V A C DRESSING USE This and all V A C dressings distributed by KCI are to be used exclusively with the V A C device WARNING Do not pack the foam into any areas of the wound Forcing foam dressings in a compressed manner into any wound is contrary to KCI recommendations Signs of possible infection may include fever tenderness rednes
18. und conditions and pain tolerance as directed by a treating physician e Adjustable Negative Pressure Settings Negative pressures can be set between 50 and 200mmHg in increments of 25 mmHg as directed by a treating physician e Adjustable Therapy Application of negative pressure can be selected for continuous or intermittent application as directed by a treating physician e Therapy Hour Meter The total time therapy is applied can be displayed and reset by the caregiver e Integrated IV Pole Clamp Allows the therapy unit to be attached to a range of IV poles 2 2 to 5cm 9 2 in diameter e Therapy Lockout The caregiver can disable the touchscreen controls to prevent unwanted changes e Footboard Hanger Extended hanger arm can fit over a range of footboard designs SKCI OPERATING INSTRUCTIONS Setting up the V A C ATS Unit Touch Screen Canister Release Button Green Power ON Switch P P Canister Port j Power Cord 1 Apply dressing according to instructions listed on page 8 For canister installation please refer to page9 2 Place the therapy unit on the footboard of the bed using the self adjusting hanger which accommodates up to a 7 5cm 3 thickness footboard Alternatively the therapy unit can be hung on a suitable IV pole using the integrated IV Pole Clamp located on the rear of the case Always operate therapy unit in an upright position CAUTION The IV Pole Clamp should
19. y unit will automatically turn off and will remain off even if plugged into AC mains power To restore power turn the therapy unit off then on again using the green power switch amp KCI k CLASSIFICATION SPECIFICATIONS Equipment not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Type B Equipment Class II Equipment with internal electrical power source PHYSICAL DATA Dimensions Weight ELECTRICAL DATA Voltage Frequency Maximum power consumption ENVIRONMENTAL DATA Storage Conditions lemperature range Relative humidity range Atmospheric pressure range Operating Conditions lemperature range Relative humidity range Atmospheric pressure range 14 6 37cm W x 11 28cm H x 7 1 18cm D 12 3lbs 5 6kg 100 240 V 50 60Hz 70W 4 F 20 C to 140 F 60 C 10 to 95 Non Condensing 700hPa to 1060hPa 50 F 10 C to 86 F 30 C 30 to 75 500hPa to 1060hPa Specifications subject to change without notice SKCI EXPLANATION OF SYMBOLS HARDWARE Class Il ON Equipment Type B C OFF part of the Equipment equipment only Pw Alternating Current STERILE DISPOSABLES LOT LOT BATCH N REFER TO USERS INSTRUCTIONS METHOD OF STERILE R STERILIZATION hd FEIBGIBE IRRADIATION EXPIRATION KEEP DRY DATE DATE OF MANUFACTURE G SINGLE USE ONLY 15 30 C STORAGE f The V A C ATS CONFORMS T
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