Osto Innovations, LLC Complete User Manual
Contents
1. TABLE 2 APPLIANCE SIZE STANDARD CONFIGURATIONS MEME 3 5 6 8 9 0 It is important to note that OstomyVac sizing is inconsistent with Coloplast sizing Please follow the chart above 4 2 RING OstomyVac is designed to be used exclusively with standard Click to Lock Coloplast Ostomy pouches 4 3 TUBING The vacuum line between the OstomyVac and the Ovac is comprised of medical grade tubing It is through this tubing that the vacuum level is drawn OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 Note 1 If moisture does happen to collect in this line IGNORE IT Moisture is potentially caused by perspiration forming under the OstomyVac and then traveling down into the vacuum line A liquid separator is provided to prevent liquid from reaching the pump Liquid that may accumulate in the OstomyVac Tubing Ref Figure 2 Item 4 3 poses no problem as long as a liquid separator is in use When changing out the OstomyVac any moisture that may have accumulated in the vacuum line can be removed using the syring provided in every kit The pamphlet OstomyVac Service Procedure provides instructions on how to use the syringe to remove the moisture CONNECTOR The connector is the joint to connect the OstomyVac to the Liquid Separator Ensure that the two pieces are fully engaged by twisting clockwise until firmly conne2. coon Standalone 1 Application Tool TABLE 1 OstomyVac KIT BREAKDOWN COMPONENTS THAT ARE NOT IN USE SHALL BE STORED IN THEIR ORIGINAL PLASTIC PACKAGAING OstomyVac User s Manual 4 Page OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 FIGURE 2 APPLIANCE DIAGRAM Shown without Adhesive Disc or Cotton Membrane The appliance is the device that is the interface between the stoma and the pouch The appliance is attached to the user s body using adhesive and vacuum The vacuum does not assist with or effect stoma output The appliance is made of soft highly flexible medical grade silicone and is configured for optimizing comfort while minimizing adhesive contact area with peristomal skin APPLIANCE FEATURES 4 1 APPLIANCE SIZING The OstomyVac is available in thirteen standard sizes and shapes to accommodate most stoma configurations as listed in Table 2 OstomyVac is also available as a custom made appliance that precisely conforms to each individual user s unique stoma For added comfort all edges and surfaces that contact the peristomal skin area are soft and complaint no sharp edges or rigid surfaces OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 CIRCULAR CONFIG DIAMETER D 5 COLOR 1 Green 2 Green 3 Green Green 5 Green Red 7 Red Red 10 OVAL CONFIG LENGTH L x HEIGHT H iNCHES MM COLOR
3. OVAC HAS BEEN START UP EVEN WITH PERMANENTLY gt A NEW BATTERY DAMAGED SYMPTON VACUUM LINE HAS OVAC VACUUM LINE FIRMLY PUSH OVAC DISENGAGED FROM gt HAS BEEN YANKED OUT gt VACUUM LINE BACK OVAC OF OVAC BLACK BOX INTO THE PLASTIC BOX SYMPTON OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 10 0 WARRANTY STATEMENT Osto Innovations LLC warrants all products to be free of defects in material and workmanship of OstomyVac Appliance and or Ovac Vacuum Pump for a period of one year commencing from date of shipment Osto Innovations will issue a Return Material Authorization RMA Number to any user who wishes to return defective products for warranty consideration An RMA number must be issued before any materials are returned Warranty consideration is subject to review of returned items see Limitations and Exclusions and application of warranty is to be determined by Osto Innovations LLC in its sole discretion Osto Innovations LLC reserves the right to make design changes in appliance and accessories without incurring obligation to incorporate these changes in products previously shipped At original purchaser s discretion items determined to be defective will be subject to either 1 Arefund of the purchase price minus a 1096 restocking fee or Replacement of defective parts with new materials the original warra
4. OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 OstomyVac User s Manual DOCOO1RO03 THIRD EDITION MANUFACTURED BY OSTO INNOVATIONS 2633 LANTANA RD BUILDING 1301 SUITE 46 LANTANA FL 33462 PHONE 561 601 8838 CUSTOMERSUPPORT OSTOUSA COM IMPORTANT READ MANUAL BEFORE USE OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 Table of Contents 1 0 INTRODUCTION 2 0 WARNINGS 3 0 OstomyVac KIT COMPONENTS 3 1 BREAKDOWN OF OstomyVac 4 0 OstomyVac OVERVIEW 5 0 OVAC OVERVIEW 5 7 OVAC LOGIC 5 7 1 ON OFF 5 7 2 VACUUM PUMP CONTROLS 5 7 3 VIBRATION MOTOR CONTROLS 5 7 4 HEARTBEAT 6 0 INSTRUCTIONS FOR USE 6 1 PREPARATION AND ATTACHMENT OF YOUR OSTOMYVAC 6 2 DAILY BATTERY REPLACEMENT 6 3 BATTERY CHARGING 6 4 CONNECTING YOUR TETHER FOR BATHING 6 5 CONNECTING YOUR DRYBOX FOR SHOWERING AND SWIMMING 7 0 DAILY ACTIVITIES 7 1 SHOWERING 7 2 BATHING 7 3 SWIMMING 7 4 SLEEPING 8 0 SECURING YOUR OVAC 8 1 8 2 9 0 TROUBLESHOOTING 10 0 WARRANTY STATEMENT OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 1 0 INTRODUCTION Osto Innovations LLC has developed and patented an ostomy appliance that utilizes vacuum to supplement the attachment of Coloplast ostomy pouches to the body The OstomyVac appliance is made of soft highly flexible medical grade silic
5. RY y SECURE OVAC IN OSTOMY BELT POCKET Remove Belt and Disconnect Liquid Separator from OstomyVac Peel back silicone appliance from body Users may wish to use an adhesive remover Put items aside and remove battery for later charging Inspect peristomal skin and discontinue use if irritation or ulceration is present Clean peristomal skin area using an anti microbial cleanser and then pat dry Some users may choose to apply a no sting skin barrier Cavilon or equivalent Vacuum tube orientation shall be horizontal to body facing towards belly button Align OstomyVacTM opening with stoma and lightly press device against body Align OstomyVac with center of hole in Ostomy Belt Ensure pockets are accessible from the outside Tighten velcro strap First connect OsomtyVac to liquid separator Second connect Ovac to liquid separator Connectors shall be twisted clockwise until hand tight Assure lamp illuminates for 2 seconds confirming full battery charge Depress inner and outer edges of OstomyVac until Ovac ceases to vibrate confirming vacuum seal integrity Slide Ovac into belt pocket OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 6 2 DAILY BATTERY REPLACEMENT OPEN ACCESS DOOR ON OVAC Using battery extraction tool REMOVE BATTERY Pry battery out of battery holder using extraction tool Reference Section 6 3 for battery INSTALL FULLY chargin
6. after inserting the battery you can expect the vibration motor to start vibrating and continue to run until adequate vacuum level has been established 5 7 4 HEARTBEAT The OstomyVac has a built in heartbeat The heartbeat is a blinking light that illuminates every 12 seconds assuring normal operation If the heartbeat ceases to blink the unit is not operating and the user should replace the battery OstomyVac User s Manual OSTO INNOVATIONS Change Your Life US Patent Number 8 454 568 6 0 INSTRUCTIONS FOR USE 6 1 PREPARATION AND ATTACHMENT OF YOUR OSTOMYVAC LAYOUT COMPONENTS ONA CLEAN SURFACE Y INSTALL LIQUID SEPARATOR Y PREPARE A FRESH OSTOMYVAC COMPONENTS INCLUDE OstomyVac Apliance e Ovac Cotton Membrane e Battery Adhesive Disc e Ostomy Belt Cotton Membrane Application Tool e Liquid Separator Install liquid separator into Ostomy Belt pocket No connections are made at this time Elbow fitting is positioned on the top of the Ostomy Belt Reference Material OstomyVac Service Procedure brochure End Result is a silicone appliance with a new adhesive disc and cotton membrane NEW USERS GO TO STEP 5 Y REMOVE OSTOMYVAC FROM THE BODY i CLEAN PERISTOMAL SKIN AREA Y ATTACH OSTOMYVAC TO BODY v PUT ON OSTOMY BELT CONNECT LIQUID SEPERATOR INSTALL BATTE
7. cted HAND TIGHT ONLY A loose connection could cause a vacuum leak not good OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 4 5 ADHESIVE DISC COVERED WITH COTTON MEMBRANE FIGURE 3 OSTOMYVAC DIAGRAM 4 5 ADHESIVE DISC The primary purpose of the adhesive disc is to secure the OstomyVac device to the body The appliance cannot be worn without the adhesive disc and cotton membrane The adhesive disc and cotton membrane should be changed every three days COTTON MEMBRANE The purpose of the cotton membrane is to distribute vacuum over the peristomal skin for adhesion enhancement The OstomyVac will not work properly if the adhesive disc and cotton membrane are not installed Detailed step by step instructions for installing the adhesive disc and cotton membrane are provided in the OstomyVac Service Procedure This pamphlet is contained in the shipping box DISCONTINUE THE USE OF PRODUCT IN THE EVENT OF ANY SKIN IRRITATION OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 5 3 TUBING 5 2 CONNECTOR 5 4 BATTERY Small side facing upward 5 1 PUMP HOUSING 5 5 ACCESS DOOR 5 6 VENT HOLE A FIGURE 4 OVAC VACUUM PUMP MODULE The primary function of the Ovac is to maintain the vacuum level over the peristomal skin The Ovac is merely a black box autonomously controlled by the internal electronics T
8. e OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 3 0 OstomyVac KIT COMPONENTS The OstomyVac is comprised of a soft highly flexible appliance integrated with an adhesive disk and cotton membrane as illustrated below The OstomyVac shall not be used unless all three components are properly assembled OSTOMYVAC COMPONENTS H20 Adhesive Disc Cotton Membrane Appliance Vacuum Pump Components Battery Extraction Tool OvacTM Vacuum Rechargeable Liquid Battery Pump Battery Separator Charger ANCILLARY COMPONENTS Drybox 6 Extension Tube Cotton Membrane Ostomy Belt Tether Application Tool FIGURE 1 OSTOMYVAC OVAC amp ANCILLARY COMPONENTS OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 3 1 BREAKDOWN OF OstomyVac KIT EXCEPT FOR DISPOSABLES each kit contains components that are designed to provide reliable performance for a period of one year The kit is delivered with two months worth of disposables adhesive and membranes Disposables should be reordered monthly COMPONENT TYPE KIT QUANTITY OF SPARES Adhesive Disc Disposable Maintain reserve stock Cotton Membrane Disposable of 5 sets at all times attery Extraction 1 Tool Rechargeable B Liquid Separator Standalone Oa 0 Extension Tube rat 1
9. e their individual preference as to what the best configuration is for sleeping A pouch cover or belt is preferred since they provide secure attachment of the Ovac to the body The user may also allow the Ovac to merely reside in bed since damage will not occur to the plastic case if slept on top of There is slight risk of pulling the OstomyVac from the body using this configuration which would result in leakage OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 8 0 SECURING YOUR OVAC There are several options available for securing your Ovac during bathing showering swimming along with normal use Accessories such as pouch covers belts and a drybox allow for use of the OstomyVac during these activities 8 1 POUCH COVER The pouch cover is made from high quality durable fabrics and serves the dual purpose of adding stylish accent while securing the Ovac The pouch cover can be purchased from C amp S Ostomy Pouch Covers Upon ordering be sure to order the pouch cover designated for Osto Innovations C amp S Ostomy Pouch Covers WWW cspouchcovers com 941 429 8030 8 2 BELT A large width cotton spandex belt is available to enhance OstomyVac security while providing a pocket to hold the Ovac The large width helps to prevent skin folds and is not visible through loose fitting clothing Belts can be purchased directly from Osto Innovations OstomyVac User s Ma
10. g CHARGED BATTERY Verify POSITIVE side is facing down Very Important REINSTALL ACCESS Push in door until an audible click is heard DOOR Make sure door is completely closed Holding Ovac in one hand 6 3 BATTERY CHARGING Flip up plug in terminals on charger and plug charger into PLUG CHARGER INTO 115 volt receptacle WALL OUTLET Green POWER light on charger is ON STATUS light will be OFF Y PLACE EMPTY BATTERY INTO CHARGER Y Battery Full STATUS light is OFF and green POWER lights is ON REMOVE FULLY To remove the battery pry the metal clip holding the CHARGED BATTERY amp battery away from the battery and battery will pop out of INSTALL IN OVAC charger Battery is ready for use in Ovac e VERY IMPORTANT Insert battery with Positive side up e While the battery is charging the yellow STATUS light is ON OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 6 4 CONNECTING YOUR TETHER FOR BATHING DISCONNECT VACUUM LINE BETWEEN OVAC AND OSTOMYVAC Y CONNECT OSTOMYVAC TO TETHER Y CONNECT TETHER TO OVAC e Untwist connector to separate OstomyVac and Ovac Note Ovac will run including vibration motor while the tubes are disconnected Ovac will turn off once connectors are reconnected and the vacuum level has been restored Connect end of tether to co
11. he only interaction required with the Ovac is opening the access door to replace the battery Besides the access door the Ovac enclosure shall NOT be opened to avoid damage OVAC FEATURES 5 1 OVAC HOUSING The Ovac housing is a black plastic enclosure that is NOT water tight Putting in water will damage the Ovac voiding warranty 5 2 CONNECTOR The connector is the joint to connect the OvacTM to the Liquid Separator Ensure that the two matching pieces are fully engaged by twisting clockwise hand tight only until firmly connected A loose connection could cause a vacuum leak not good OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 5 3 TUBING The vacuum tubing is comprised of medical grade tubing It is through this line that the vacuum level is drawn Note If Moisture happens to accumulate in this tube ignore it DO NOT attach a syringe to this section of tubing as it will damage the BATTERY A lithiom ion battery 3 6 Volts powers the Ovac The battery is sized to last for three days before replacement is necessary In spite of that it is highly recommended to change the battery daily to avoid the possibility of low battery charge See Section 6 3 for the battery replacement procedure The Ovac has the ability confirm a full battery charge at start up the moment when battery is installed If the inserted battery is full
12. ion instructions The second option is to enclose the in the water tight Drybox and let it lay on the shower floor refer to Section 6 5 for Drybox installation instructions This option allows the user more mobility during showering After showering is an ideal time to do the daily battery replacement to maximize battery life 7 2 BATHING While bathing the user should connect the tether so as to keep the Ovac out of direct contact with water Refer to Section 6 4 for tether installation instructions After bathing is an ideal time to do the daily battery replacement to maximize battery life 7 3 SWIMMING The Drybox shall be used whenever the user is swimming so as to protect the Ovac from water damage Refer to Section 6 5 for Drybox installation instructions Before swimming in public pools confirm below to maintain hygiene at pool protecting all 1 Correct Battery use Section 5 4 2 OstomyVac has a good seal against the body If a good seal has not been achieved the user can expect the vibration motor to turn on Section 6 7 3 OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 If while swimming the user notices a breach in the seal the user should place their hand on the OstomyVac securing it in place and exit the pool Osto Innovations is not liable for any contamination to a public or private swimming pool 7 4 SLEEPING The user will determin
13. measure vacuum level over the peristomal skin area A micro vacuum pump is automatically turned on and off to precisely maintain the proper vacuum level The pump is typically on for less than half a second 0 5 second when vacuum is needed to maintain normal adhesion This is consistent for every user The time interval between pump ON can range from every fifteen minutes to hours depending on the user 5 7 3 VIBRATION MOTOR CONTROLS The Ovac incorporates a feature for detecting leakage of the OstomyVac In the event the vacuum pump runs for more than two seconds consistent with a leak a vibration motor will turn on It will shake the Ovac box similar to a cell OstomyVac User s Manual 11 Page OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 phone vibration mechanism Once the vacuum is restored depressing the appliance onto the body the vibration motor will turn off The vibration motor will run until the leak has been restored Note When a battery is installed in the Ovac the unit will continue to run until sufficient vacuum level is attained in the OstomyVac So as to maximize battery life after charging the battery should not be installed until all vacuum lines are connected and the OstomyVac is fully attached to the body Under this condition the vacuum pump will normally run less than two seconds to establish adequate vacuum level If vacuum is not established within two seconds
14. nty expiration date will remain in force Replacements are shipped at the expense of Osto Innovations LLC SATISFACTION GUARANTEE Osto Innovations LLC guarantees customer satisfaction If for any reason see Limitations and Exclusions the user is not completely satisfied with our products OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 OstomyVac Appliance and or Ovac Vacuum Pump they may be returned within 60 days of the date of shipment for a full refund minus a 10 restocking fee LIMIATIONAS AND EXCLUSIONS User neglect user modification and mishandling nullify any consideration for refund LIABILITY WAIVER Osto Innovations LLC is not liable for any injury or loss that occurs because this product is used other than is intended or without consultation with a medical professional RETURN INSTRUCTIONS For safety and health reasons please return all used OstomyVac appliances in sealed zip lock bags For warranty consideration or refund please ship items in original boxes if possible to Osto Innovations LLC 2633 Lantana Road Building 1301 Suite 46 Lantana Florida 33462 Shipping costs of returned materials are the customer s responsibility We recommend returns be shipped via UPS or Fed Ex with an assigned tracking number to validate receipt Ensure RMA number is documented somewhere ON or IN the package Please allow 5 business days for warranty con
15. nual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 9 0 TROUBLESHOOTING LAMP OVAC DOES BATTERY IS NOT FULL NOT ILLUMINATE FOR AND DOES NOT MEET 2 SECONDS UPON REQUIREMENT FOR START UP OPERATION REMOVE EMPTY BATTERY AND PUT IN gt CHARGER REPLACE WITH FULLY CHARGED BATTERY SYMPTON INNER or OUTER SEALS PRESS DOWN AROUND ARE NOT PROPERLY gt THE INNER amp OUTER SEALED AGAINST THE SEALS UNTIL VIBE PUMP AND VIBE SKIN MOTOR TURNS OFF MOTOR RUN VACUUM IS NOT CONTINOUSLY ON ESTABLISHED B C REMOVE ADHESIVE DISC START UP ADHSIVE DISC amp AND COTTON COTTON MEMBRANE MEMBRANE AND ARE INSTALLED REPLACE WITH NEW INCORRECTLY SYMPTON COCE one uals BREAKDOWN OF REMOVE OSTOMYVAC THE PUMP OVAC BENG ON ADHESIVE AND REPLACE WITH FREQUENTIY OR COMPROMISES FRESHLY PREPARED CONTINUOUSLY VACUUM SEAL UNIT SYMPTON REMOVE EMPTY BATTERY AND PUT IN gt BATTERY IS EMPTY CHARGER REPLACE WITH FULLY CHARGED BATTERY HEARTBEAT LAMP ON OVAC 15 NOT BLINKING EVERY 10 SECONDS SYMPTON REMOVE OVAC AND REPLACE WITH SPARE ALLOW WET UNIT TO DRY OUT FOR 24hrs OVAC MAKES A MOISTURE WATER SPITTING OR gt HASENTEREDTHE gt SPUTTERING NOISE OVAC SYMPTON REQUEST RMA FROM OSTO INNOVATIONS RETURN DAMAGED UNIT FOR REPLACEMENT IN THE MEANTIME OPERATION IS WITH ONLY 1 OVAC DOES NOT
16. one which provides an interface between a Coloplast ostomy pouch and the user s stoma The vacuum that supplements attachment to skin is provided by a fully automated Ovac vacuum pump module The OstomyVac appliance and Ovac vacuum pump operate as a single system and must not be used independent of each other OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 2 0 WARNINGS It is important that the following warnings are carefully read and understood prior to using the OstomyVac appliance N PLEASE READ CAREFULLY N Discontinue the use of product in the event of skin irritation Do not apply this appliance to peristomal skin that is irritated or ulcerated Osto Innovations LLC is not liable for any injury or loss that occurs if this product is used other than is intended or without consultation with a medical professional Consult doctor or stoma nurse WOCN prior to using a convex product Do not put batteries in direct contact with each other Do not put more than one battery in a single plastic baggie Ovac vacuum pump shall not be immersed or in direct contact with water refer to Section 7 Proper Usage Shower amp Bathing contained herein Components shall not be stored at temperatures above 120 F i e in a closed automobile during summer months The OstomyVac must not be used without proper installation of both an adhesive disc and cotton membran
17. rresponding OstomyVac connector Connect free end of tether to Ovac Now the Ovac can be remotely located up to 6 feet away from the user 6 5 CONNECTING YOUR DRYBOX FOR SHOWERING AND SWIMMING HELPFUL TIP Pinching off Ovac vacuum line will keep the Ovac from running during this operation DISCONNECT VACUUM LINE BETWEEN OVAC AND OSTOMYVAC OSTOMYVAC Y CONNECT TETHER TO DRYBOX Y CONNECT DRYBOX TO OVAC e Untwist connector to separate OstomyVac and Ovac Note Ovac will run including vibration motor while the tubes are disconnected Ovac will turn off once connectors are reconnected and the vacuum level has been restored Connect end of tether to corresponding OstomyVac connector Connect free end of tether to Drybox connector Unpinch vacuum line if it has been pinched off Place Ovac inside of drybox Connect Ovac to drybox connector Place connectors on top of Ovac and close drybox Snap shut to lock Verify the tubes are not pinched in the inside the drybox OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 7 0 DAILY ACTIVITIES 7 1 SHOWERING There are two options available for protecting the Ovac from water damage during showering The first option is to hang the Ovac by its tether out of direct contact with water refer to Section 6 4 for tether installat
18. sideration and notification by phone email or mail OstomyVac User s Manual
19. y charged a lamp inside the Ovac will illuminate for 2 seconds at start up If the battery is installed and the lamp does not illuminate for 2 seconds the battery is not fully charged and requires replacement NOTE As shown in Figure 4 the smaller side of the battery faces upward The side marked with an faces downward BATTERIES NOT IN USE SHALL BE STORED IN THEIR OWN INDIVIDUAL PLASTIC CONTAINER ACCESS DOOR This is a sliding door that provides access to the battery compartment at the time of battery replacement VENT HOLE The vacuum pump outlet is vented to the outside of the Ovac case through this hole OstomyVac User s Manual OSTO INNOVATIONS US Patent Number Change Your Life 8 454 568 5 7 OVAC LOGIC The Ovac vacuum pump module is a rather simple device that controls the operation of the vacuum pump vibration motor and heartbeat 5 7 1 OVACTM ON OFF The ON OFF function is controlled by installing and removing the battery There is no ON OFF switch only the battery When the battery is INSTALLED the vacuum pump turns ON When the battery is REMOVED the vacuum pump turns OFF You can expect the vacuum pump to turn ON as soon as the battery is installed The Ovac has a built in safety feature that will automatically shut the unit OFF in a safe manner in the event the battery is inadvertently left installed 5 7 2 VACUUM PUMP CONTROLS The Ovac uses a vacuum sensor to precisely
Download Pdf Manuals
Related Search