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Vashe User manual

The document provides instructions for using the Vashe Wound Therapy System, including: - An overview of the system components and their functions. - Directions for installing containers, filling the generator with electrolyte solution, and priming the generator. - Explanations of the control panel and operating modes for dispensing wound therapy solution. - Guidelines for maintenance, service, ordering supplies, and troubleshooting issues.

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PuriCore, Inc. 508 Lapp Road Malvern, PA 19355 866.918.2743 484.321.2700 www.puricore.com 0001-0227 Rev C User Manual ®
2 Vashe Wound Therapy 866.918.2743 VASHE WOUND THERAPY SYSTEM SERVICE AND LIMITATION OF LIABILITY PuriCore retains title to the Vashe Wound Therapy System, which may only be serviced and maintained by PuriCore authorized service personnel. PuriCore, will, at its discretion, repair or replace components of the Vashe Wound Therapy System with equivalent units, parts, and/or the Vashe Electrolyte Solution as appropriate. Contact your PuriCore representative for more information. PURICORE EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. WITHOUT LIMITING THE FOREGOING LIMITED WARRANTY AND DISCLAIMER, PURICORE SPECIFICALLY DOES NOT OFFER, AND HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE VASHE WOUND THERAPY SYSTEM BE USEFUL FOR OR RESULT IN TREATMENT, DIAGNOSIS OR DETECTION OF ANY DISEASE, ILLNESS, INFECTION OR CONDITION. IN NO EVENT SHALL PURICORE BE LIABLE FOR ANY ACTUAL, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, REGARDLESS OF THE BASIS FOR THE CAUSE OF ACTION. USE THE VASHE WOUND THERAPY SYSTEM ONLY AS DIRECTED. FOLLOW ALL INSTRUCTIONS CAREFULLY. HEED ALL WARNINGS AND OBEY ALL APPLICABLE LAWS, REGULATIONS, SAFETY AND INDUSTRY STANDARDS AND PRACTICES. DO NOT INSTALL OR OPERATE THIS VASHE WOUND THERAPY SYSTEM IF YOU HAVE NOT REVIEWED THIS MANUAL OR IF ANY INSTUCTIONS ARE UNCLEAR OR UNFAMILIAR TO YOU. PURICORE SHALL NOT BE LIABLE FOR INJURIES, DAMAGES OR LOSSES OF ANY KIND SUSTAINED AS A RESULT OF USING THIS VASHE WOUND THERAPY SYSTEM IN ANY MANNER THAT IS INCONSISTENT WITH THE INSTRUCTIONS CONTAINED IN THIS USER MANUAL OR ANY MATERIALS, DOCUMENTATION OR LABELING REGARDING THE VASHE WOUND THERAPY SYSTEM. © 2012 PuriCore, Inc. All rights reserved. PuriCore and Vashe are registered trademarks of PuriCore, Inc. All other brands and products referenced in this document are acknowledged to be the trademarks or registered trademarks of their respective owners. Except for creation of back-up copies, this guide may not be copied in whole or in part, without the express written consent of PuriCore, Inc. Parts of this Vashe Wound Therapy System and the proper operation are covered by one or more claims in the U.S. by patents including U.S. Patent 6,528,214 and U.S. Patent 6,632,347. PuriCore, Inc. 508 Lapp Road Malvern, PA 19365 866.918.2743 484.321.2700 866.918.2743 Vashe Wound Therapy 23 Notes
22 Vashe Wound Therapy 866.918.2743 Technical Information Electrical Supply Mains (Nominal) ..............................................................................................100-240V/50-60 Hz Maximum Current........................................................................................................................3.5 amps Fuses (2 used: T3.15AH250V)..............................................................................3.15A, 250V time delay Supply Voltage Variance.................................................................................................. 10% of Nominal Environmental Temperature for Use ....................................................................................................Room temperature Storage Temperature (Vashe Electrolyte Solution) ..................................................10º-30º C (50º-85º F) Operations Duty Type....................................................................................................Unit can operate continuously Fluid Capacity Internal Tank ...............................................................................................................................4.0 Liters Dispense Container..........................................................................................................................500ml Waste Container ..............................................................................................................................150ml Physical Characteristics Weight (with no Electrolyte)............................................................................................ 5.2 Kg (11.5 lbs.) Weight (with 4.0 liters of Electrolyte) .............................................................................. 9.0 Kg (19.8 lbs.) Height................................................................................................................................323 mm (12.7") Width....................................................................................................................................381 mm (15") Depth ................................................................................................................................206 mm (8.11") 866.918.2743 Vashe Wound Therapy 3 Warranty and Limitation of Liability ................................................... 2 Introduction........................................................................................ 4 Installation and Priming..................................................................... 7 Operating Procedures ....................................................................... 9 Precautions ..................................................................................... 12 Maintenance.................................................................................... 15 Service ............................................................................................ 18 Supplies & Accessories................................................................... 19 Troubleshooting............................................................................... 20 Technical Information...................................................................... 22 Table of Contents My Vashe Wound Therapy Generator Serial Number:
4 Vashe Wound Therapy 866.918.2743 Introduction The Vashe Wound Therapy System manufactures a ready-to-use solution formulated to effectively clean, irrigate, moisten, and debride acute and chronic dermal lesions such as Stage I through IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings. The Vashe Wound Therapy System includes the Vashe Wound Therapy Generator, which produces a hypochlorous (HOCl) solution, Vashe Wound Therapy Solution. This solution is non-cytotoxic, non-mutagenic, and has shown no contact hypersensitivity and no oral toxicity. Shipping Contents Consists of a Vashe Wound Therapy Generator and precursor Vashe Electrolyte Solution. See the contents below. Vashe Wound Therapy System* Vashe Electrolyte Solution (Sold separately: see page 19) Power Cord User Manual Vashe Wound Therapy Generator Optional Drain Tube Dispense and Waste Containers Bottler Risers * Vashe Wound Therapy Solution fill bottles are supplied separately. 866.918.2743 Vashe Wound Therapy 21 Problem Solution When testing the Vashe Wound Therapy Solution as described on page 10 of this User Manual, the AFC level or pH range is not within the specified range. Dispose of the Vashe Wound Therapy Solution in the container and re-dispense at least 250ml of fresh Vashe Wound Therapy Solution. Retest. If the problem persists, call PuriCore The Vashe Wound Therapy Solution has a very strong chlorine odor. Test the Vashe Wound Therapy Solution as described on page 10 of this User Manual. If the AFC level or pH range reading is not within the specified range, call PuriCore Customer Service. The error code does not clear after powering the Vashe Wound Therapy Call PuriCore Customer Service. The funnel screen in the reservoir has trapped debris. Remove and rinse the screen. If the screen is damaged, call PuriCore
20 Vashe Wound Therapy 866.918.2743 Troubleshooting Problem Solution You are missing a part, or the Vashe Wound Therapy Generator is cracked or broken. Call PuriCore Customer Service. The unit fails to power on, which means that none of the lights are illuminated on either the Reservoir Status Panel or the Mode Panel. Check the fuses. If the fuses are okay, call PuriCore Customer Service. You are out of Vashe Electrolyte Solution. Call PuriCore Customer Service to order additional Vashe Electrolyte Solution. The Vashe Wound Therapy Solution or the Vashe Waste Product has spilled in the well(s). Dry the well(s) with absorbent paper towel. Ensure the containers and/or optional drain tube are installed as described on page 7 of this User Manual. Always select the appropriate dispense volume to avoid overflow. Empty the waste container regularly. If the Vashe Generator continues to leak, ensure that the waste extension sleeve is placed properly over the spout. When starting with an empty waste container, the waste container overflows with waste product on a single 500 ml dispense. Discontinue use immediately and call PuriCore Customer Service. The Vashe Test Strips indicate the presence of hypocholorous acid, but says it is too high or too low. Use the Palintest 1000 Chlorometer Duo to measure the AFC level of the Vashe PuriCore Customer Service: 866.918.2743 Have your Vashe Wound Therapy Generator serial number ready (located on the back cover). 866.918.2743 Vashe Wound Therapy 5 Introduction Vashe Electrolyte Solution The Vashe Electrolyte Solution is used by the Vashe Wound Therapy Generator to make the Vashe Wound Therapy Solution. The use of any other solution is unauthorized and will void any applicable product warranty. Vashe Wound Therapy Solution The Vashe Wound Therapy Solution (hypochlorous, HOCl) is produced by the Vashe Wound Therapy Generator and is used to cleanse wounds, as a debridement irrigant, and in dressing management. Waste Product The waste product (dilute sodium hydroxide, NaOH) is produced by the Vashe Wound Therapy Generator and is collected in the waste container in the lower well (or in the optional drain tube). This product should be emptied into a sink drain when necessary. The waste product is safe for disposal in drains. Vashe Wound Therapy Solution Definitions Reservoir Status Panel Mode PanelDispense Button Dispense Container Well Waste Container Well Vashe Wound Therapy Fill Bottle (sold separately: see page 19) Waste Container Waste Label Autofill Dispense: 250ml Autofill Dispense: 500ml Manual Dispense Stop Dispense Vashe Wound Therapy Generator
6 Vashe Wound Therapy 866.918.2743 Vashe Wound Therapy Generator Controls The Reservoir Status Panel displays two lights to indicate the level in the Electrolyte reservoir. The green OK light indicates that the unit is ready to be used. The yellow LOW light indicates that the reservoir requires one gallon of Vashe Electrolyte Solution. Flashing lights indicate that an error has occurred. The Mode Panel enables the user to select autofill dispensing of two volumes, 250ml (8 oz.) or 500ml (16 oz.), or to operate the unit manually with Manual mode. The STOP button clears the current operation and resets the selected mode. Autofill mode: Select a desired dispense volume with the Mode Panel, then press the gray dispense button to generate Vashe Wound Therapy Solution. Press the gray dispense button again to pause the operation. Press it a third time to restart the original fill request. (The unit will remember how much dispense time has elapsed and will resume the autofill to the requested volume.) Pressing the STOP button on the Mode Panel will stop the current generation of the solution and clear any remaining time of dispense. Manual mode: Select the Manual dispense mode on the Mode Panel, then depress and continue to hold down the gray dispense button to generate Vashe Wound Therapy Solution. Release the gray dispense button to stop generation. If the Manual mode is used, a minimum of 250ml must be produced to keep the Vashe Wound Therapy Solution within specification. Pressing the gray dispense button Using the Mode Panel Introduction Reservoir Status OK Mode Panel Reservoir Status Low 866.918.2743 Vashe Wound Therapy 19 Ordering Vashe Wound Therapy Supplies and Accessories To order Vashe Wound Therapy supplies, call PuriCore Customer Service at 866.918.2743. Supplies & Accessories Item PuriCore Part Number Vashe Wound Therapy Solution Fill Bottle Packs Vashe Electrolyte Solution Case of 4 1-gallon bottles 6000-6021 Case of 2 1-gallon bottles 6000-0003 Vashe Wound Therapy Test Strips (AFC) 3000-3037 Palintest 1000 Chlorometer-Duo Meter 3000-3001 Replacement Waste Spout Sleeve 5000-5189 Vashe Sample Bottle Kit 7000-0011 Pack of 56 250ml Vashe Wound Therapy Fill Bottles 7000-0028 Pack of 28 500ml Vashe Wound Therapy Fill Bottles 7000-0030 Palintest Tablets 3000-3013
18 Vashe Wound Therapy 866.918.2743 Vashe Wound Therapy Generator Service If the Vashe Wound Therapy Generator requires service, follow the instructions below. 1. Call PuriCore Customer Service at 1-866-91-Vashe (1-866-918-2743). 2. Have the Vashe Wound Therapy Generator serial number (located on the back cover of the Generator) available to give to the Customer Service Representative. 3. If the PuriCore Customer Service Representative cannot solve the problem over the phone, you will be given instructions on how to return the Vashe Wound Therapy Generator. If the Generator qualifies under the original factory or extended warranty terms and conditions, a replacement unit will be shipped to you at no charge. The replacement Vashe Wound Therapy Generator will have the remaining balance of the original or extended warranty coverage. 4. It is imperative that the reservoir tank be completely drained before shipping the Vashe Wound Therapy Generator. Drain the reservoir tank as described in the “Draining the Reservoir Tank” section on page 16 of this User Manual. 5. Place the Vashe Wound Therapy Generator in the original shipping box or in the box provided by PuriCore Customer Service. 6. Return the Vashe Wound Therapy Generator as instructed by the PuriCore Customer Service Representative. Service 866.918.2743 Vashe Wound Therapy 7 Installation and Priming 2. Power On the Generator Select a level surface on which to operate the Vashe Wound Therapy Generator. The Generator should be positioned for easy access to the rear power switch. Connect the power cord to the back of the Vashe Wound Therapy Generator and plug the other end into an AC power outlet with a grounded receptacle. Press the ON/ OFF switch on the rear switch to the On position. Observe that the yellow LOW light on the Reservoir Status Panel is illuminated. 3. Install the Containers and/or Optional Drain Tube Insert the dispense container or a bottle with the bottle riser in the top well of the Vashe Wound Therapy Generator. If using the waste container, ensure that the waste extension sleeve (1/2-inch clear Teflon tube) is placed over the waste spout. An extra sleeve has been provided for your convenience. Insert the waste container in the bottom well. If the Generator is equipped with the waste drain option, firmly connect the drain tube to the drain fitting on the bottom of the Vashe Generator using the quick connect fitting. Ensure that the drain tube is directed to a sink or a waste container. The drain tubing must be kept free- flowing. Do not kink the tubing or otherwise restrict the flow with clamps or additional fittings. You can shorten the tubing but do not extend the tubing in any manner. Do not raise the end of the tubing above the bottom of the Vashe Wound Therapy Generator. The tubing should be horizontal or vertically pointed downward. Caution: Read all warning and safety instructions before operating the Vashe Wound Therapy Generator. 1. Unpack the Vashe Wound Therapy Generator Discard any packing material. Do not apply power to the Vashe Wound Therapy Generator until all packing materials are removed. Power on the Generator. If using the waste container, install the sleeve on the waste spout. If using the drain tube, connect the tube to the connector on the bottom of the Generator.
8 Vashe Wound Therapy 866.918.2743 Fill the Generator with Vashe Electrolyte Solution This initial portion of the Vashe Wound Therapy Solution primes the Generator’s electrochemical cell, is not suitable for use, and should be discarded down a sink drain. Dispose of the waste product in the waste container as well. Replace both the dispense container and waste container into their respective wells. Wait 10 minutes before using the Vashe Wound Therapy Generator again. Note: During the initial priming process, the Generator will beep and blink the lights on the Reservoir Status Panel and the Mode Panel as the unit initiates its alerts. Turn the power off and then on to reset the alerts. Repeat the priming procedure two to three times until the Generator no long beeps or blinks to complete the priming. 4. Fill the Generator with Vashe Electrolyte Solution Lift the fill lid on top of the Vashe Wound Therapy Generator. Carefully and slowly pour an entire bottle of the Vashe Electrolyte Solution into the funnel. The green OK light on the Reservoir Status Panel will illuminate. Use caution when pouring the Vashe Electrolyte Solution to avoid spills. 5. Prime the Generator The priming process conditions the Vashe Wound Therapy Generator for use and is only needed when it is first unboxed or unused for an extended period. Select the Manual button on the Mode Panel and then hold down the gray dispense button to dispense 250ml of Vashe Wound Therapy Solution into the dispense container. Installation and Priming 866.918.2743 Vashe Wound Therapy 17 Replacing the Fuses The two fuses located on the back of the Vashe Wound Therapy Generator are the only user-serviceable parts. CAUTION: Read the fuse label located on the back of the Vashe Wound Therapy Generator before fuse replacement. Replace the fuses only with those of the same type and rating. The Vashe Wound Therapy Generator is protected by two 3.15A, 250V time delay fuses. 1. Power off the Vashe Wound Therapy Generator and remove the cord. 2. With a small flat screwdriver, open the door to the power entry module, as shown in the upper photo to the right. 3. With the same small flat screwdriver, pull out the fuse holder assembly, as shown in the lower photo to the right. 4. Replace the blown fuses. 5. Reinstall the fuse holder assembly and plug in the power cord. Power on Vashe Wound Therapy Generator and proceed as normal. Maintenance Open door of the power entry module Fuse holder assembly
16 Vashe Wound Therapy 866.918.2743 Draining the Reservoir Tank When preparing the Vashe Wound Therapy Generator for shipment or transport, you must drain the Vashe Electrolyte Solution as follows. 1. Power off the Vashe Wound Therapy Generator and remove the power cord. 2. Carefully position the Vashe Wound Therapy Generator over the sink. 3. While maintaining the Vashe Wound Therapy Generator in an upright position, reach under the bottom of the unit to access the drain plug. 4. With a flat screwdriver, remove the plug by turning the plug head counterclockwise. 5. When the Vashe Electrolyte Solution stops flowing, slightly tip the unit side to side to empty the tank of residual electrolyte solution. 6. When the draining is completed, insert the plug into the drain hole and turn it clockwise until fully inserted. Do not over-tighten the plug. Over-tightening the plug can strip the threads and cause the Vashe Electrolyte Solution to leak when refilling. Always replace the plug immediately after draining the Vashe Electrolyte Solution. Maintenance Remove the plug with a flat screwdriver. Empty the reservoir tank of all residual Vashe Electrolyte Solution. 866.918.2743 Vashe Wound Therapy 9 Operating Procedures Generate Vashe Wound Therapy Solution To generate Vashe Wound Therapy Solution, first use the Mode Panel to select a desired dispense volume in Autofill mode or select Manual mode. Press the STOP button at any time to stop the current operation and reset the selected mode. Autofill mode: Press the gray dispense button to generate Vashe Wound Therapy Solution. You can pause operation by pressing the dispense button again and restart it by pressing the dispense button a third time. A blinking light on the selected Autofill button on the Mode Panel indicates that the generation of Vashe Wound Therapy Solution is in process. This light will continue to blink even when the Generator is paused. Upon dispensing the selected volume, the Generator will automatically stop dispensing and the appropriate Autofill button light will be illuminated steadily. Manual mode: Press and continue to hold down the gray dispense button to generate Vashe Wound Therapy Solution. Release the dispense button to stop the generation of Vashe Wound Therapy Solution. Never generate less than 250ml of the Vashe Wound Therapy Solution to ensure that it is within specification. Generate additional Vashe Wound Therapy Solution as required, emptying the waste container when necessary. Ensure an Adequate Electrolyte Level If during an Autofill operation the electrolyte level runs low, the Generator will cease generation of Vashe Wound Therapy Solution, and the yellow LOW light on the Reservoir Status will be illuminated. The light on the selected Autofill button of the Mode Panel will continue to blink, and the Generator will beep every 10 seconds. Replenish the electrolyte, ensure that the green OK light on the Reservoir Status is illuminated, and press the gray dispense button to complete the current fill. In the Manual mode, the Generator will stop operation when there is no electrolyte.
10 Vashe Wound Therapy 866.918.2743 Test the Vashe Wound Therapy Solution Available Free Chlorine (AFC) Concentration: Use one of the two available methods to test the Vashe Wound Therapy Solution for the proper concentration: Palintest ® 1000 Chlorometer-Duo Meter. When using the meter, follow the operating procedure provided with the instrument. The acceptable range is 150-250ppm AFC. Contact PuriCore Customer Service if your Vashe Wound Therapy Solution is out of specification. Vashe Wound Therapy Analysis Kit. Take sample as directed and ship using the enclosed envelope. PuriCore will analyze the sample and report the findings to you. Available Free Chlorine (AFC) Presence Indicator: Vashe Wound Therapy Test Strips. When using the Vashe Wound Therapy Test Strips, follow the "Directions for Use" provided, which depict the acceptable color range. Note that these strips only indicate the presence of hypochlorous acid in the Vashe Wound Therapy Solution, not the actual concentration. To order these test strips or the Palintest meter, see page 19 of this User Manual. Vashe Wound Therapy Solution Directions for Use Operating Procedures Vashe Wound Therapy Solution is cleared to clean, irrigate, moisten and debride acute and chronic dermal lesions. It can be used in the following methods. • Flush or flood a wound by pouring Vashe Wound Therapy Solution directly on the wound site. • Soak the wound in the Vashe Wound Therapy Solution in various types of baths. • Swab the wound using gauze soaked in Vashe Wound Therapy Solution. • Moisten a wound dressing liberally with Vashe Wound Therapy Solution and cover the wound bed. • Administer Vashe Wound Therapy in a wound using a trigger-activated spray or pulsed lavage device with an adjustable nozzle that produces a stream of liquid at approximately 8 to 14 psi. • To keep a wound dressing moist, apply additional Vashe Wound Therapy Solution as needed. 866.918.2743 Vashe Wound Therapy 15 Maintenance Warnings: Always unplug the power cord from the the back of the Vashe Wound Therapy Generator before initiating any maintenance procedures to avoid shock or damage to unit. Never allow fluid to enter the power entry connection. Never place a filled Vashe Wound Therapy Generator on its side or upside down. Cleaning the Vashe Wound Therapy Generator’s Exterior • Always clean the exterior of the Vashe Wound Therapy Generator in its upright position. • Keep the funnel lid closed while cleaning. Seepage of cleaning solution into the funnel will contaminate the solution in the reservoir tank. • Remove the dispense and waste containers from the wells of the Vashe Wound Therapy Generator. Wash the containers separately from the Vashe Wound Therapy Generator. Use a solution of mild liquid detergent and warm tap water. • Do not apply cleaning solution directly to the Vashe Wound Therapy Generator. Slightly dampen a cotton cloth, paper cloth, or sponge with a solution of mild liquid detergent and warm tap water. Clean all exterior surfaces of the Generator. Once cleaned, the surface can be wiped with a dry cloth.
14 Vashe Wound Therapy 866.918.2743 Precautions General Operating Precautions Do not kink, crimp, or otherwise obstruct the flow of the optional drain tubing. Do not elevate the drain tubing above the bottom of the Vashe Wound Therapy Generator. You can cut the drain tubing to length but do not extend the drain tubing in any way with fittings or couplings. Add Vashe Electrolyte Solution to the Vashe Wound Therapy Generator only when the Vashe Wound Therapy Generator is powered ON and the yellow LOW light on the Reservoir Status is illuminated. Always pour the entire contents of the Vashe Electrolyte Solution bottle into the Generator. The green OK light on the Reservoir Status indicates that there is enough Vashe Electrolyte Solution in the reservoir tank. Overfilling the Vashe Electrolyte Solution can damage the electric components of the Vashe Wound Therapy Generator and will void the warranty. Never top-off, overfill the tank, or add Vashe Electrolyte Solution while the green OK light is illuminated. If all lights on the Vashe Wound Therapy Generator are flashing, cycle the power off and then on to clear any errors. Vashe Electrolyte Solution is not a wound cleansing solution. Vashe Wound Therapy Solution is the wound cleansing product generated by the Vashe Wound Therapy System. Never pour the Vashe Wound Therapy Solution or the Vashe Waste Product back into the Generator. 866.918.2743 Vashe Wound Therapy 11 WARNING: For external use only. Not for injection. HANDLING: Vashe Wound Therapy Solution is non-irritating and non- sensitizing to skin and eyes and requires no special handling precautions. STORAGE: Store in the Vashe-labeled, approved opaque, tightly-capped HDPE containers at room temperature for up to 30 days unopened. Once opened, the solution must be used within 7 days. Do not store in unauthorized containers. INGREDIENTS: DISPOSAL: Vashe Wound Therapy Solution is safe to the environment. No special disposal considerations are required for unused Vashe Wound Therapy Solution. Discard any unused Vashe Wound Therapy Solution within 24 hours if left in an uncapped container. Vashe Wound Therapy Solution Appearance and Odor It is normal for the Vashe Wound Therapy Solution to appear slightly cloudy at times. The cloudiness will dissipate in a few minutes. Vashe Wound Therapy Solution will have a mild chlorine odor. The Generator Self-Diagnostics and Error Monitoring The Vashe Wound Therapy Generator monitors internal parameters and performs self-diagnostics. If an error condition occurs, the unit will begin to blink all the lights on both the Reservoir Status Panel and the Mode Panel. The Vashe Wound Therapy Generator will beep once, and then it will beep the number of the error code. Cycling the power off and then on will clear the error code. You can do this without damage to the Generator. Operating Procedures Water 99.574% Sodium chloride 0.4% Hypochlorous acid 0.025% Sodium chlorate 0.001%
12 Vashe Wound Therapy 866.918.2743 Warnings and Cautions For your protection, read these safety instructions completely and keep this guide for further reference. Observe and comply with all warnings, cautions, and instructions placed on the Vashe Wound Therapy Generator or described in the installation and operating instructions. UL Approved: This device has been tested as laboratory equipment in accordance with applicable UL (Underwriters Laboratory) specifications and meets specified electronic leakage requirements. Warnings: This symbol located on the Vashe Wound Therapy Generator is intended to alert you to a possible electrical shock hazard. Use only an approved power cord set. If you are not sure as to the proper power cord to use with your Vashe Wound Therapy Generator, contact your sales person, your PuriCore sales representative, or call PuriCore Customer Service. Do not operate the Vashe Wound Therapy Generator if there is damage to the power cord or plug, if the Generator is malfunctioning, or if it has been dropped or otherwise damaged. Never attach or detach the Vashe Wound Therapy Generator from a source of AC power with wet hands. Do not directly touch or apply power or disconnect power if the power cord is wet. Use a dry glove or towel to avoid a possible shock hazard. Never pull on the power cord to remove the plug from an outlet. Grasp the plug and pull to disconnect. Do not attempt to service the Vashe Wound Therapy Generator yourself as opening the Generator housing risks a shock hazard that could result in serious injury or death. Opening the Vashe Wound Therapy Generator for any reason will void any applicable product warranty. Contact PuriCore Customer Service to return the Vashe Wound Therapy Generator for repair. Do not allow Vashe Electrolyte Solution to spill over the back of the Generator when filling. Precautions 866.918.2743 Vashe Wound Therapy 13 Precautions Cautions: Be certain to read and understand the important safety and operating information below before proceeding. Monitor the waste container levels and dispose the waste product as needed. When disposing the waste product, avoid contact with eyes, skin, mucous membranes, or clothing. Do not allow the waste product to be inhaled or ingested. Wash your hands after handling. Vashe Wound Therapy Solution might cause slight discoloration of some unprotected metals such as aluminum and steel. Use the Vashe Wound Therapy Generator only as described in this user manual and only with the accessories supplied or recommended by PuriCore. Use only the approved Vashe Electrolyte Solution. Use of any other solution can severely damage the Vashe Wound Therapy Generator and void the warranty. Never operate the Vashe Wound Therapy Generator unless both the dispense container (or a bottle on the bottle riser) and the waste container (or drain tubing) are inserted into the wells of the Generator. Always use the Vashe Wound Therapy Generator on a firm, level surface to ensure against tipping. Do not move the unit when it is filled with fluid unless the Generator is malfunctioning and must be drained. Operate the Generator in an upright position. Placing unit on its side or on its back or front risks the spilling of Vashe Electrolyte Solution and other damage.

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Vashe User manual

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    PuriCore, Inc. 508 LappRoad Malvern, PA 19355 866.918.2743 484.321.2700 www.puricore.com 0001-0227 Rev C User Manual ®
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    2 Vashe WoundTherapy 866.918.2743 VASHE WOUND THERAPY SYSTEM SERVICE AND LIMITATION OF LIABILITY PuriCore retains title to the Vashe Wound Therapy System, which may only be serviced and maintained by PuriCore authorized service personnel. PuriCore, will, at its discretion, repair or replace components of the Vashe Wound Therapy System with equivalent units, parts, and/or the Vashe Electrolyte Solution as appropriate. Contact your PuriCore representative for more information. PURICORE EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. WITHOUT LIMITING THE FOREGOING LIMITED WARRANTY AND DISCLAIMER, PURICORE SPECIFICALLY DOES NOT OFFER, AND HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE VASHE WOUND THERAPY SYSTEM BE USEFUL FOR OR RESULT IN TREATMENT, DIAGNOSIS OR DETECTION OF ANY DISEASE, ILLNESS, INFECTION OR CONDITION. IN NO EVENT SHALL PURICORE BE LIABLE FOR ANY ACTUAL, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, REGARDLESS OF THE BASIS FOR THE CAUSE OF ACTION. USE THE VASHE WOUND THERAPY SYSTEM ONLY AS DIRECTED. FOLLOW ALL INSTRUCTIONS CAREFULLY. HEED ALL WARNINGS AND OBEY ALL APPLICABLE LAWS, REGULATIONS, SAFETY AND INDUSTRY STANDARDS AND PRACTICES. DO NOT INSTALL OR OPERATE THIS VASHE WOUND THERAPY SYSTEM IF YOU HAVE NOT REVIEWED THIS MANUAL OR IF ANY INSTUCTIONS ARE UNCLEAR OR UNFAMILIAR TO YOU. PURICORE SHALL NOT BE LIABLE FOR INJURIES, DAMAGES OR LOSSES OF ANY KIND SUSTAINED AS A RESULT OF USING THIS VASHE WOUND THERAPY SYSTEM IN ANY MANNER THAT IS INCONSISTENT WITH THE INSTRUCTIONS CONTAINED IN THIS USER MANUAL OR ANY MATERIALS, DOCUMENTATION OR LABELING REGARDING THE VASHE WOUND THERAPY SYSTEM. © 2012 PuriCore, Inc. All rights reserved. PuriCore and Vashe are registered trademarks of PuriCore, Inc. All other brands and products referenced in this document are acknowledged to be the trademarks or registered trademarks of their respective owners. Except for creation of back-up copies, this guide may not be copied in whole or in part, without the express written consent of PuriCore, Inc. Parts of this Vashe Wound Therapy System and the proper operation are covered by one or more claims in the U.S. by patents including U.S. Patent 6,528,214 and U.S. Patent 6,632,347. PuriCore, Inc. 508 Lapp Road Malvern, PA 19365 866.918.2743 484.321.2700 866.918.2743 Vashe Wound Therapy 23 Notes
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    22 Vashe WoundTherapy 866.918.2743 Technical Information Electrical Supply Mains (Nominal) ..............................................................................................100-240V/50-60 Hz Maximum Current........................................................................................................................3.5 amps Fuses (2 used: T3.15AH250V)..............................................................................3.15A, 250V time delay Supply Voltage Variance.................................................................................................. 10% of Nominal Environmental Temperature for Use ....................................................................................................Room temperature Storage Temperature (Vashe Electrolyte Solution) ..................................................10º-30º C (50º-85º F) Operations Duty Type....................................................................................................Unit can operate continuously Fluid Capacity Internal Tank ...............................................................................................................................4.0 Liters Dispense Container..........................................................................................................................500ml Waste Container ..............................................................................................................................150ml Physical Characteristics Weight (with no Electrolyte)............................................................................................ 5.2 Kg (11.5 lbs.) Weight (with 4.0 liters of Electrolyte) .............................................................................. 9.0 Kg (19.8 lbs.) Height................................................................................................................................323 mm (12.7") Width....................................................................................................................................381 mm (15") Depth ................................................................................................................................206 mm (8.11") 866.918.2743 Vashe Wound Therapy 3 Warranty and Limitation of Liability ................................................... 2 Introduction........................................................................................ 4 Installation and Priming..................................................................... 7 Operating Procedures ....................................................................... 9 Precautions ..................................................................................... 12 Maintenance.................................................................................... 15 Service ............................................................................................ 18 Supplies & Accessories................................................................... 19 Troubleshooting............................................................................... 20 Technical Information...................................................................... 22 Table of Contents My Vashe Wound Therapy Generator Serial Number:
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    4 Vashe WoundTherapy 866.918.2743 Introduction The Vashe Wound Therapy System manufactures a ready-to-use solution formulated to effectively clean, irrigate, moisten, and debride acute and chronic dermal lesions such as Stage I through IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings. The Vashe Wound Therapy System includes the Vashe Wound Therapy Generator, which produces a hypochlorous (HOCl) solution, Vashe Wound Therapy Solution. This solution is non-cytotoxic, non-mutagenic, and has shown no contact hypersensitivity and no oral toxicity. Shipping Contents Consists of a Vashe Wound Therapy Generator and precursor Vashe Electrolyte Solution. See the contents below. Vashe Wound Therapy System* Vashe Electrolyte Solution (Sold separately: see page 19) Power Cord User Manual Vashe Wound Therapy Generator Optional Drain Tube Dispense and Waste Containers Bottler Risers * Vashe Wound Therapy Solution fill bottles are supplied separately. 866.918.2743 Vashe Wound Therapy 21 Problem Solution When testing the Vashe Wound Therapy Solution as described on page 10 of this User Manual, the AFC level or pH range is not within the specified range. Dispose of the Vashe Wound Therapy Solution in the container and re-dispense at least 250ml of fresh Vashe Wound Therapy Solution. Retest. If the problem persists, call PuriCore The Vashe Wound Therapy Solution has a very strong chlorine odor. Test the Vashe Wound Therapy Solution as described on page 10 of this User Manual. If the AFC level or pH range reading is not within the specified range, call PuriCore Customer Service. The error code does not clear after powering the Vashe Wound Therapy Call PuriCore Customer Service. The funnel screen in the reservoir has trapped debris. Remove and rinse the screen. If the screen is damaged, call PuriCore
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    20 Vashe WoundTherapy 866.918.2743 Troubleshooting Problem Solution You are missing a part, or the Vashe Wound Therapy Generator is cracked or broken. Call PuriCore Customer Service. The unit fails to power on, which means that none of the lights are illuminated on either the Reservoir Status Panel or the Mode Panel. Check the fuses. If the fuses are okay, call PuriCore Customer Service. You are out of Vashe Electrolyte Solution. Call PuriCore Customer Service to order additional Vashe Electrolyte Solution. The Vashe Wound Therapy Solution or the Vashe Waste Product has spilled in the well(s). Dry the well(s) with absorbent paper towel. Ensure the containers and/or optional drain tube are installed as described on page 7 of this User Manual. Always select the appropriate dispense volume to avoid overflow. Empty the waste container regularly. If the Vashe Generator continues to leak, ensure that the waste extension sleeve is placed properly over the spout. When starting with an empty waste container, the waste container overflows with waste product on a single 500 ml dispense. Discontinue use immediately and call PuriCore Customer Service. The Vashe Test Strips indicate the presence of hypocholorous acid, but says it is too high or too low. Use the Palintest 1000 Chlorometer Duo to measure the AFC level of the Vashe PuriCore Customer Service: 866.918.2743 Have your Vashe Wound Therapy Generator serial number ready (located on the back cover). 866.918.2743 Vashe Wound Therapy 5 Introduction Vashe Electrolyte Solution The Vashe Electrolyte Solution is used by the Vashe Wound Therapy Generator to make the Vashe Wound Therapy Solution. The use of any other solution is unauthorized and will void any applicable product warranty. Vashe Wound Therapy Solution The Vashe Wound Therapy Solution (hypochlorous, HOCl) is produced by the Vashe Wound Therapy Generator and is used to cleanse wounds, as a debridement irrigant, and in dressing management. Waste Product The waste product (dilute sodium hydroxide, NaOH) is produced by the Vashe Wound Therapy Generator and is collected in the waste container in the lower well (or in the optional drain tube). This product should be emptied into a sink drain when necessary. The waste product is safe for disposal in drains. Vashe Wound Therapy Solution Definitions Reservoir Status Panel Mode PanelDispense Button Dispense Container Well Waste Container Well Vashe Wound Therapy Fill Bottle (sold separately: see page 19) Waste Container Waste Label Autofill Dispense: 250ml Autofill Dispense: 500ml Manual Dispense Stop Dispense Vashe Wound Therapy Generator
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    6 Vashe WoundTherapy 866.918.2743 Vashe Wound Therapy Generator Controls The Reservoir Status Panel displays two lights to indicate the level in the Electrolyte reservoir. The green OK light indicates that the unit is ready to be used. The yellow LOW light indicates that the reservoir requires one gallon of Vashe Electrolyte Solution. Flashing lights indicate that an error has occurred. The Mode Panel enables the user to select autofill dispensing of two volumes, 250ml (8 oz.) or 500ml (16 oz.), or to operate the unit manually with Manual mode. The STOP button clears the current operation and resets the selected mode. Autofill mode: Select a desired dispense volume with the Mode Panel, then press the gray dispense button to generate Vashe Wound Therapy Solution. Press the gray dispense button again to pause the operation. Press it a third time to restart the original fill request. (The unit will remember how much dispense time has elapsed and will resume the autofill to the requested volume.) Pressing the STOP button on the Mode Panel will stop the current generation of the solution and clear any remaining time of dispense. Manual mode: Select the Manual dispense mode on the Mode Panel, then depress and continue to hold down the gray dispense button to generate Vashe Wound Therapy Solution. Release the gray dispense button to stop generation. If the Manual mode is used, a minimum of 250ml must be produced to keep the Vashe Wound Therapy Solution within specification. Pressing the gray dispense button Using the Mode Panel Introduction Reservoir Status OK Mode Panel Reservoir Status Low 866.918.2743 Vashe Wound Therapy 19 Ordering Vashe Wound Therapy Supplies and Accessories To order Vashe Wound Therapy supplies, call PuriCore Customer Service at 866.918.2743. Supplies & Accessories Item PuriCore Part Number Vashe Wound Therapy Solution Fill Bottle Packs Vashe Electrolyte Solution Case of 4 1-gallon bottles 6000-6021 Case of 2 1-gallon bottles 6000-0003 Vashe Wound Therapy Test Strips (AFC) 3000-3037 Palintest 1000 Chlorometer-Duo Meter 3000-3001 Replacement Waste Spout Sleeve 5000-5189 Vashe Sample Bottle Kit 7000-0011 Pack of 56 250ml Vashe Wound Therapy Fill Bottles 7000-0028 Pack of 28 500ml Vashe Wound Therapy Fill Bottles 7000-0030 Palintest Tablets 3000-3013
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    18 Vashe WoundTherapy 866.918.2743 Vashe Wound Therapy Generator Service If the Vashe Wound Therapy Generator requires service, follow the instructions below. 1. Call PuriCore Customer Service at 1-866-91-Vashe (1-866-918-2743). 2. Have the Vashe Wound Therapy Generator serial number (located on the back cover of the Generator) available to give to the Customer Service Representative. 3. If the PuriCore Customer Service Representative cannot solve the problem over the phone, you will be given instructions on how to return the Vashe Wound Therapy Generator. If the Generator qualifies under the original factory or extended warranty terms and conditions, a replacement unit will be shipped to you at no charge. The replacement Vashe Wound Therapy Generator will have the remaining balance of the original or extended warranty coverage. 4. It is imperative that the reservoir tank be completely drained before shipping the Vashe Wound Therapy Generator. Drain the reservoir tank as described in the “Draining the Reservoir Tank” section on page 16 of this User Manual. 5. Place the Vashe Wound Therapy Generator in the original shipping box or in the box provided by PuriCore Customer Service. 6. Return the Vashe Wound Therapy Generator as instructed by the PuriCore Customer Service Representative. Service 866.918.2743 Vashe Wound Therapy 7 Installation and Priming 2. Power On the Generator Select a level surface on which to operate the Vashe Wound Therapy Generator. The Generator should be positioned for easy access to the rear power switch. Connect the power cord to the back of the Vashe Wound Therapy Generator and plug the other end into an AC power outlet with a grounded receptacle. Press the ON/ OFF switch on the rear switch to the On position. Observe that the yellow LOW light on the Reservoir Status Panel is illuminated. 3. Install the Containers and/or Optional Drain Tube Insert the dispense container or a bottle with the bottle riser in the top well of the Vashe Wound Therapy Generator. If using the waste container, ensure that the waste extension sleeve (1/2-inch clear Teflon tube) is placed over the waste spout. An extra sleeve has been provided for your convenience. Insert the waste container in the bottom well. If the Generator is equipped with the waste drain option, firmly connect the drain tube to the drain fitting on the bottom of the Vashe Generator using the quick connect fitting. Ensure that the drain tube is directed to a sink or a waste container. The drain tubing must be kept free- flowing. Do not kink the tubing or otherwise restrict the flow with clamps or additional fittings. You can shorten the tubing but do not extend the tubing in any manner. Do not raise the end of the tubing above the bottom of the Vashe Wound Therapy Generator. The tubing should be horizontal or vertically pointed downward. Caution: Read all warning and safety instructions before operating the Vashe Wound Therapy Generator. 1. Unpack the Vashe Wound Therapy Generator Discard any packing material. Do not apply power to the Vashe Wound Therapy Generator until all packing materials are removed. Power on the Generator. If using the waste container, install the sleeve on the waste spout. If using the drain tube, connect the tube to the connector on the bottom of the Generator.
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    8 Vashe WoundTherapy 866.918.2743 Fill the Generator with Vashe Electrolyte Solution This initial portion of the Vashe Wound Therapy Solution primes the Generator’s electrochemical cell, is not suitable for use, and should be discarded down a sink drain. Dispose of the waste product in the waste container as well. Replace both the dispense container and waste container into their respective wells. Wait 10 minutes before using the Vashe Wound Therapy Generator again. Note: During the initial priming process, the Generator will beep and blink the lights on the Reservoir Status Panel and the Mode Panel as the unit initiates its alerts. Turn the power off and then on to reset the alerts. Repeat the priming procedure two to three times until the Generator no long beeps or blinks to complete the priming. 4. Fill the Generator with Vashe Electrolyte Solution Lift the fill lid on top of the Vashe Wound Therapy Generator. Carefully and slowly pour an entire bottle of the Vashe Electrolyte Solution into the funnel. The green OK light on the Reservoir Status Panel will illuminate. Use caution when pouring the Vashe Electrolyte Solution to avoid spills. 5. Prime the Generator The priming process conditions the Vashe Wound Therapy Generator for use and is only needed when it is first unboxed or unused for an extended period. Select the Manual button on the Mode Panel and then hold down the gray dispense button to dispense 250ml of Vashe Wound Therapy Solution into the dispense container. Installation and Priming 866.918.2743 Vashe Wound Therapy 17 Replacing the Fuses The two fuses located on the back of the Vashe Wound Therapy Generator are the only user-serviceable parts. CAUTION: Read the fuse label located on the back of the Vashe Wound Therapy Generator before fuse replacement. Replace the fuses only with those of the same type and rating. The Vashe Wound Therapy Generator is protected by two 3.15A, 250V time delay fuses. 1. Power off the Vashe Wound Therapy Generator and remove the cord. 2. With a small flat screwdriver, open the door to the power entry module, as shown in the upper photo to the right. 3. With the same small flat screwdriver, pull out the fuse holder assembly, as shown in the lower photo to the right. 4. Replace the blown fuses. 5. Reinstall the fuse holder assembly and plug in the power cord. Power on Vashe Wound Therapy Generator and proceed as normal. Maintenance Open door of the power entry module Fuse holder assembly
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    16 Vashe WoundTherapy 866.918.2743 Draining the Reservoir Tank When preparing the Vashe Wound Therapy Generator for shipment or transport, you must drain the Vashe Electrolyte Solution as follows. 1. Power off the Vashe Wound Therapy Generator and remove the power cord. 2. Carefully position the Vashe Wound Therapy Generator over the sink. 3. While maintaining the Vashe Wound Therapy Generator in an upright position, reach under the bottom of the unit to access the drain plug. 4. With a flat screwdriver, remove the plug by turning the plug head counterclockwise. 5. When the Vashe Electrolyte Solution stops flowing, slightly tip the unit side to side to empty the tank of residual electrolyte solution. 6. When the draining is completed, insert the plug into the drain hole and turn it clockwise until fully inserted. Do not over-tighten the plug. Over-tightening the plug can strip the threads and cause the Vashe Electrolyte Solution to leak when refilling. Always replace the plug immediately after draining the Vashe Electrolyte Solution. Maintenance Remove the plug with a flat screwdriver. Empty the reservoir tank of all residual Vashe Electrolyte Solution. 866.918.2743 Vashe Wound Therapy 9 Operating Procedures Generate Vashe Wound Therapy Solution To generate Vashe Wound Therapy Solution, first use the Mode Panel to select a desired dispense volume in Autofill mode or select Manual mode. Press the STOP button at any time to stop the current operation and reset the selected mode. Autofill mode: Press the gray dispense button to generate Vashe Wound Therapy Solution. You can pause operation by pressing the dispense button again and restart it by pressing the dispense button a third time. A blinking light on the selected Autofill button on the Mode Panel indicates that the generation of Vashe Wound Therapy Solution is in process. This light will continue to blink even when the Generator is paused. Upon dispensing the selected volume, the Generator will automatically stop dispensing and the appropriate Autofill button light will be illuminated steadily. Manual mode: Press and continue to hold down the gray dispense button to generate Vashe Wound Therapy Solution. Release the dispense button to stop the generation of Vashe Wound Therapy Solution. Never generate less than 250ml of the Vashe Wound Therapy Solution to ensure that it is within specification. Generate additional Vashe Wound Therapy Solution as required, emptying the waste container when necessary. Ensure an Adequate Electrolyte Level If during an Autofill operation the electrolyte level runs low, the Generator will cease generation of Vashe Wound Therapy Solution, and the yellow LOW light on the Reservoir Status will be illuminated. The light on the selected Autofill button of the Mode Panel will continue to blink, and the Generator will beep every 10 seconds. Replenish the electrolyte, ensure that the green OK light on the Reservoir Status is illuminated, and press the gray dispense button to complete the current fill. In the Manual mode, the Generator will stop operation when there is no electrolyte.
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    10 Vashe WoundTherapy 866.918.2743 Test the Vashe Wound Therapy Solution Available Free Chlorine (AFC) Concentration: Use one of the two available methods to test the Vashe Wound Therapy Solution for the proper concentration: Palintest ® 1000 Chlorometer-Duo Meter. When using the meter, follow the operating procedure provided with the instrument. The acceptable range is 150-250ppm AFC. Contact PuriCore Customer Service if your Vashe Wound Therapy Solution is out of specification. Vashe Wound Therapy Analysis Kit. Take sample as directed and ship using the enclosed envelope. PuriCore will analyze the sample and report the findings to you. Available Free Chlorine (AFC) Presence Indicator: Vashe Wound Therapy Test Strips. When using the Vashe Wound Therapy Test Strips, follow the "Directions for Use" provided, which depict the acceptable color range. Note that these strips only indicate the presence of hypochlorous acid in the Vashe Wound Therapy Solution, not the actual concentration. To order these test strips or the Palintest meter, see page 19 of this User Manual. Vashe Wound Therapy Solution Directions for Use Operating Procedures Vashe Wound Therapy Solution is cleared to clean, irrigate, moisten and debride acute and chronic dermal lesions. It can be used in the following methods. • Flush or flood a wound by pouring Vashe Wound Therapy Solution directly on the wound site. • Soak the wound in the Vashe Wound Therapy Solution in various types of baths. • Swab the wound using gauze soaked in Vashe Wound Therapy Solution. • Moisten a wound dressing liberally with Vashe Wound Therapy Solution and cover the wound bed. • Administer Vashe Wound Therapy in a wound using a trigger-activated spray or pulsed lavage device with an adjustable nozzle that produces a stream of liquid at approximately 8 to 14 psi. • To keep a wound dressing moist, apply additional Vashe Wound Therapy Solution as needed. 866.918.2743 Vashe Wound Therapy 15 Maintenance Warnings: Always unplug the power cord from the the back of the Vashe Wound Therapy Generator before initiating any maintenance procedures to avoid shock or damage to unit. Never allow fluid to enter the power entry connection. Never place a filled Vashe Wound Therapy Generator on its side or upside down. Cleaning the Vashe Wound Therapy Generator’s Exterior • Always clean the exterior of the Vashe Wound Therapy Generator in its upright position. • Keep the funnel lid closed while cleaning. Seepage of cleaning solution into the funnel will contaminate the solution in the reservoir tank. • Remove the dispense and waste containers from the wells of the Vashe Wound Therapy Generator. Wash the containers separately from the Vashe Wound Therapy Generator. Use a solution of mild liquid detergent and warm tap water. • Do not apply cleaning solution directly to the Vashe Wound Therapy Generator. Slightly dampen a cotton cloth, paper cloth, or sponge with a solution of mild liquid detergent and warm tap water. Clean all exterior surfaces of the Generator. Once cleaned, the surface can be wiped with a dry cloth.
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    14 Vashe WoundTherapy 866.918.2743 Precautions General Operating Precautions Do not kink, crimp, or otherwise obstruct the flow of the optional drain tubing. Do not elevate the drain tubing above the bottom of the Vashe Wound Therapy Generator. You can cut the drain tubing to length but do not extend the drain tubing in any way with fittings or couplings. Add Vashe Electrolyte Solution to the Vashe Wound Therapy Generator only when the Vashe Wound Therapy Generator is powered ON and the yellow LOW light on the Reservoir Status is illuminated. Always pour the entire contents of the Vashe Electrolyte Solution bottle into the Generator. The green OK light on the Reservoir Status indicates that there is enough Vashe Electrolyte Solution in the reservoir tank. Overfilling the Vashe Electrolyte Solution can damage the electric components of the Vashe Wound Therapy Generator and will void the warranty. Never top-off, overfill the tank, or add Vashe Electrolyte Solution while the green OK light is illuminated. If all lights on the Vashe Wound Therapy Generator are flashing, cycle the power off and then on to clear any errors. Vashe Electrolyte Solution is not a wound cleansing solution. Vashe Wound Therapy Solution is the wound cleansing product generated by the Vashe Wound Therapy System. Never pour the Vashe Wound Therapy Solution or the Vashe Waste Product back into the Generator. 866.918.2743 Vashe Wound Therapy 11 WARNING: For external use only. Not for injection. HANDLING: Vashe Wound Therapy Solution is non-irritating and non- sensitizing to skin and eyes and requires no special handling precautions. STORAGE: Store in the Vashe-labeled, approved opaque, tightly-capped HDPE containers at room temperature for up to 30 days unopened. Once opened, the solution must be used within 7 days. Do not store in unauthorized containers. INGREDIENTS: DISPOSAL: Vashe Wound Therapy Solution is safe to the environment. No special disposal considerations are required for unused Vashe Wound Therapy Solution. Discard any unused Vashe Wound Therapy Solution within 24 hours if left in an uncapped container. Vashe Wound Therapy Solution Appearance and Odor It is normal for the Vashe Wound Therapy Solution to appear slightly cloudy at times. The cloudiness will dissipate in a few minutes. Vashe Wound Therapy Solution will have a mild chlorine odor. The Generator Self-Diagnostics and Error Monitoring The Vashe Wound Therapy Generator monitors internal parameters and performs self-diagnostics. If an error condition occurs, the unit will begin to blink all the lights on both the Reservoir Status Panel and the Mode Panel. The Vashe Wound Therapy Generator will beep once, and then it will beep the number of the error code. Cycling the power off and then on will clear the error code. You can do this without damage to the Generator. Operating Procedures Water 99.574% Sodium chloride 0.4% Hypochlorous acid 0.025% Sodium chlorate 0.001%
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    12 Vashe WoundTherapy 866.918.2743 Warnings and Cautions For your protection, read these safety instructions completely and keep this guide for further reference. Observe and comply with all warnings, cautions, and instructions placed on the Vashe Wound Therapy Generator or described in the installation and operating instructions. UL Approved: This device has been tested as laboratory equipment in accordance with applicable UL (Underwriters Laboratory) specifications and meets specified electronic leakage requirements. Warnings: This symbol located on the Vashe Wound Therapy Generator is intended to alert you to a possible electrical shock hazard. Use only an approved power cord set. If you are not sure as to the proper power cord to use with your Vashe Wound Therapy Generator, contact your sales person, your PuriCore sales representative, or call PuriCore Customer Service. Do not operate the Vashe Wound Therapy Generator if there is damage to the power cord or plug, if the Generator is malfunctioning, or if it has been dropped or otherwise damaged. Never attach or detach the Vashe Wound Therapy Generator from a source of AC power with wet hands. Do not directly touch or apply power or disconnect power if the power cord is wet. Use a dry glove or towel to avoid a possible shock hazard. Never pull on the power cord to remove the plug from an outlet. Grasp the plug and pull to disconnect. Do not attempt to service the Vashe Wound Therapy Generator yourself as opening the Generator housing risks a shock hazard that could result in serious injury or death. Opening the Vashe Wound Therapy Generator for any reason will void any applicable product warranty. Contact PuriCore Customer Service to return the Vashe Wound Therapy Generator for repair. Do not allow Vashe Electrolyte Solution to spill over the back of the Generator when filling. Precautions 866.918.2743 Vashe Wound Therapy 13 Precautions Cautions: Be certain to read and understand the important safety and operating information below before proceeding. Monitor the waste container levels and dispose the waste product as needed. When disposing the waste product, avoid contact with eyes, skin, mucous membranes, or clothing. Do not allow the waste product to be inhaled or ingested. Wash your hands after handling. Vashe Wound Therapy Solution might cause slight discoloration of some unprotected metals such as aluminum and steel. Use the Vashe Wound Therapy Generator only as described in this user manual and only with the accessories supplied or recommended by PuriCore. Use only the approved Vashe Electrolyte Solution. Use of any other solution can severely damage the Vashe Wound Therapy Generator and void the warranty. Never operate the Vashe Wound Therapy Generator unless both the dispense container (or a bottle on the bottle riser) and the waste container (or drain tubing) are inserted into the wells of the Generator. Always use the Vashe Wound Therapy Generator on a firm, level surface to ensure against tipping. Do not move the unit when it is filled with fluid unless the Generator is malfunctioning and must be drained. Operate the Generator in an upright position. Placing unit on its side or on its back or front risks the spilling of Vashe Electrolyte Solution and other damage.