Ultra Evac Station Instructions For Use
Contents
1. 12 DMS Technical Service Information 12 Symbols amp Labels 13 Consumables and lt 14 Use of Single Use Lids and Manifolds 14 TR 15 Protective Packaging amp 15 Site Preparation 15 Utilities Needed for Installation 16 Space 16 Water Supply 16 Electrical 16 Sanitary Sewer Drain 16 Backflow lt2. 16 De install Disconnect Instructions 18 Equipment Storage 18 A aa ae a aa 19 Qualifications for Service Personnel 19 Service Warnings 19 Additional Information 19 Routine 20 Replacement lt 20 Ultra Evac Technical Manual 2 8 2013 GD 99013 Rev D Fluid Paths and Wiring 21 Preventative Maintenance 25 Company Information 26 Contact Information 26
3. 22 Figure 13 Ultra Evac Unit Board Schematic nen 24 Ultra Evac Technical Manual 2 8 2013 GD 99013 Rev D Introduction The Transposal Ultra Evacuation Unit evac is designed to empty clean and rinse the Ultra Fluid Carts carts The evac is used to process the Ultra Quad Cart 4 reservoirs and the Ultra Duo Cart 2 reservoirs after they have been used to collect fluids in the surgical procedure Two manuals are provided with this equipment and are shipped with the equipment during the initial installation Copies of these manuals are available to any Dornoch Medical Systems Inc DMS customer upon request The two different manuals are as follows Instructions for Use Manual This manual is designed to instruct users in the correct operation of the evac as well as safety considerations associated with the unit Technical Service Manual This manual includes operation instructions installation amp disconnection instructions technical specifications and preventative maintenance procedures for the unit This is the Technical Service Manual and it is broken into seven sections including e Introduction Technical Description e Operation e Installation e Maintenance Company Information Limited Warranty As a supplement to these two manuals instructional video s are available to assist maintenance personnel in their understa
4. 9 Le eere rtu nne 405495 SCH uld s 1032 3 e227 uojng dois dung 42 Uld 6 A ddns eH 5 JMO ULN 4402s G OT T 6 1 430 Figure 12 Ultra Evac Unit Wiring Diagram 2 8 2013 22 Ultra Evac Technical Manual GD 99013 Rev D Ultra Evac Technical Manual 23 2 8 2013 GD 99013 Rev D 5 3 pa ul z mE aS 5 mg m mnm 5 gc _ D bg l T Statian Smart Logic ICB Transposal Version 6 0 Safety 533 108 2390 li 0175 ptoz 00000000 1 SD DATAKEY g O a n n Ultra Technical Manual GD 99013 Rev D arnoch Medical Systess Inc 14499R2 R a 0120 R418 Figure 13 Ultra Evac Unit Board Schematic 24 IL J 12513
5. 7 Waste Disposal Accessories 7 MSDS Sheet for Bleach and 7 Reusable Suction Reservoir Use 8 Instructions for Use 9 Processing 5 9 Reprocessing Reservoirs Optional 9 Prepare Cart for Next Case 9 Replacing Bleach amp Enzyme Bottles 10 Reprocessing Cycle Descriptions 10 Performing Verify 10 Unit Information and Error Messages 11 Periodic Maintenance 11 Troubleshooting
6. 2 Clean chemical pickup tubes in warm water 3 Call DMS at 1 888 466 6633 Problem Reservoirs are Not Washing Possible Solution 1 Verify the water to the unit is turned on 2 Check for any crimps in the black water line to the coupler on the back of the evac 3 Call DMS at 1 888 466 6633 DMS Technical Service Information DMS Technical Service is available 24 hours a day 7 days a week Technicians are available in the office from Monday Friday from 8AM until 5PM central standard time DMS uses a paging system for any calls received at other times during the day and will get back with you as soon as possible Please call 1 888 466 6633 and have the information below available for the technician If possible call with the equipment available for troubleshooting e Equipment Type Ultra Duo Ultra Quad Evac or Safety Station e Equipment Serial Number e Description of the problem e Location of the equipment e Contact information for a service technician coming to the account Ultra Evac Technical Manual 12 2 8 2013 GD 99013 Rev D Symbols amp Labels The explanation and location of all Labels Safety Signs Symbols and Displays used on the equipment is presented below Protective Earth Ground Symbol This label is used to symbolize a protective earth ground location on the unit There is one located on the ground from the main power cord and another located on the ground for the 24VDC power supply There
7. Limited Warranty 27 List of Tables Table 1 Equipment 4 Table 2 Site Utilities for 16 Table 3 Preventative Maintenance Schedule 25 List of Figures Figure 1 Ultra Evac Unit Dimensions and Features Dim 5 2 TP DL2800 Single Use 6 Figure 3 UL CESDO Single Use Manifold 6 Figure 4 Ultra Fluid Cart Connected to the Ultra Evac Unit 6 5 gt gt 9 6 Figure 7 Cleaning Cycles Sereen rr nee eoe eee 9 Figure 8 Bleach and Enzyme Bottles 10 Figure 9 Ultra Unit Architectural Drawing MMMM 17 Figure 10 Environmental 18 Figure 11 Ultra Evac Unit Fluid Flow Diagram 21 Figure 12 Ultia Evac Unit Wiring
8. WASTE where it exits the rear of the unit This label is located next to the waste line on the rear of the unit Ultra Evac Technical Manual 13 2 8 2013 GD 99013 Rev D Hot Water Label This label is used to identify the hot water line where it enters the rear of the unit This label is located next to the water line on the rear of the unit Enzyme Label This label is used to identify the inlet ENZYME location of the enzyme line This label is located next to the enzyme line on the rear of the unit Bleach Label This label is used to identify the inlet location of the bleach line This label is located next to the bleach line on the rear of the unit Consumables and Accessories The following is a list of consumables associated with the evac WARNING Use only Dornoch approved components and enzyme DO NOT modify any compohnent Of accessory e UL EZ200 Enzymatic Cleaner e TP VL100 Verification Log and Test Strips for Bleach Application Verification e UL BW100 Sani Cloth Bleach Germicidal Wipe approved surface disinfectant wipe for the carts e Clorox Bleach Use of Single Use Lids and Manifolds WARNING Both the TP DL2800 lid UL CL500 manifold are designed to be used for a single patient Failure to change the item after each patient may result in the following 1 Loss of available suction Contaminated and or wet filters will affect vacuum flow 2 Cross contamination Imp
9. claim based upon contract warranty tort or otherwise shall in no case exceed the actual value of the equipment paid by the purchaser DMS shall not be liable to the purchaser to any other person or entity for incidental or consequential damages DMS resetves the right to replace defective parts or equipment with parts which may not be identical to the original equipment or parts Said replacement parts or equipment shall be in the judgment of DMS equal to or better in performance than parts or equipment initially furnished Ultra Evac Technical Manual 27 2 8 2013 GD 99013 Rev D THIS EXPRESS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING THE IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE AND MERCHANTABILITY DMS reserves the tight to discontinue any Transposal Product incorporate new features specifications colors etc at any time without incurring obligations to provide similar equipment or features on previously sold models of equipment or parts This warranty applies to the original purchaser only and is not transferable except to the end user in a lease financed transaction and then if and only if and to the extent specifically approved by DMS in writing This limited warranty shall be construed and interpreted in accordance with and governed by the internal laws of the State of Missouri without giving effect to Missouri choice or conflict of law principles PURCH
10. inch cm 24 61 W x 20 51 D x 33 84 H Additional Cooling None Flammable Rating Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or with nitrous oxide Operation Mode Continuous Cycle 5to 16 minutes Water Use 5 0 18 9 to 10 0 37 9 gallons liters cycle Enzyme Use 5 8 172 to 10 8 319 ounces milliliters cycle Bleach Use 2 85 84 to 5 7 168 ounces milliliters cycle Cleaning Dornoch enzyme solution and Clorox bleach are used to clean the collection cylinders of the Ultra Fluid Cart Ultra Evac Technical Manual GD 99013 Rev D 4 2 8 2013 Power Coupler Indicator Hoses Power Inlet Waste Hose 20661 Hot Water Legs Inlet 33 84 16 41 Figure 1 Ultra Evac Unit Dimensions and Features Dim inch cm Ultra Evac Technical Manual 5 2 8 2013 GD 99013 Rev D Operation The Transposal Ultra Infectious Fluid Management System consists of carts for fluid collection and the evac for fluid disposal Carts collect up to 52 liters of surgical fluids without the need to tandem multiple suction canisters In addition each Ultra unit s on board vacuum pump replaces or improves facility wall vacuum performance when inadequate suction is otherwise present Once connected to a 120 VAC electrical outlet cart reservoirs collect fluids from one to three separate sites Ultra Duo Fluid Carts have two 16 5
11. liter reservoirs and Ultra Quad Fluid Carts have four 13 0 liter reservoirs Reservoirs can be used with wall vacuum and or the on board vacuum pump A single use lid Figure 2 or manifold Figure 3 is used to make suction tube connections from the field to the cart The Ultra Duo uses two single use lids or manifolds and the Ultra Quad uses four lids manifolds New lids are pressed on to the top of cart reservoirs new manifolds are inserted into the housings On carts with the single use lid only one sealed cleaned reservoir is used per patient Carts are removed from the OR suite for processing after all reservoirs have been used or at the end of the day On carts with the single use cart manifold the manifold is changed between patients to allow for multi patient fluid collection The carts are removed for processing at the Figure 2 TP DL2800 Single Use Lid end of every day Cart processing is accomplished with an evac Figure 4 located in an OR utility closet or decontamination room Evacs empty clean and rinse resetvoirs for reuse The evac s water drain and sensor lines are easily Figure 3 UL CL500 Single connected to the cart using a drip less Use Manifold all in one coupler connection Carts are powered by the evac coupler connection during reservoir processing Figure 4 Ultra Fluid Cart Connected to the Ultra Evac Unit Ultra Evac Technical Manual 6 2 8 2013 GD 9901
12. 3 Rev D Safety Features The Ultra Fluid Carts have numerous built in safety features including e Closed System Design The Ultra Fluid Carts are designed to confine and contain fluids during disposal Personnel never open cylinders that contain collected fluids e Interactive Controls The Ultra Fluid Carts high tech control system guides users through unit operation while monitoring key functions e Bleach Cycle Monitoring Continuous automatic monitoring of the bleach cycle is accomplished with electronic sensors within the Ultra Evac Unit Environmental Protection Infectious Waste None Waste Disposal Accessories There ate no current accessories required for disposal from this unit MSDS Sheet for Bleach and Enzyme MSDS sheets are available upon request by calling DMS at 1 888 466 6633 Ultra Evac Technical Manual 7 2 8 2013 GD 99013 Rev D Reusable Suction Reservoir Use and Processing Reservoir Processing WARNING Follow the current local regulations governing biohazard waste to safely handle and dispose of surgical fluid waste Carts should be processed when all of the collection reservoirs have been used or at the end of the day Designated OR SPD or housekeeping personnel shall empty and clean used carts with the evac Processing shall be accomplished in accordance with manufacturer s directions After processing wipe down the cart with a hospital approved bleach wipe Sani Cloth Bleach Germicidal Wip
13. 5244 E CN e n5 5 25 zi a e T as RU aL in my Ww D lt x lt I uz 5 i WU ao BEI RLA PLI ALB RL10 PLIU HE ra 1905 s 0 9 wA UL ng e j ui BOR uu 25 The m m ETH O epa H ME 5 ey J10 49 2 UsSCERCH RISER LEVEL 2 8 2013 Preventative Maintenance The Ultra Evac Unit preventative maintenance schedule is presented below Preventive maintenance parts kits can be ordered directly from DMS by calling 1 888 466 6633 Table 3 Preventative Maintenance Schedule Year End Required Parts Procedure 1121314 Part Quantity Annual PM Kit X X X X PM 007 1 Replace Solenoid Valve X X 12520 3 Note Preventative Maintenance Procedures are available upon request by contacting Customer Service at 1 888 466 6633 Ultra Evac Technical Manual 25 2 8 2013 GD 99013 Rev D Company Information DMS has been helping healthcare facilities responsibly manage infectious fluid waste since 1997 Starting out as the premier manufacturer for fluid waste management systems in the country we now have installations in leading healthcare facilities nation wide DMS was founded in 1995 Products are manu
14. ASER IRREVOCABLY AGREES THAT SUBJECT TO DMS SOLE AND ABSOLUTE DISCRETION ALL ACTIONS OR PROCEEDINGS IN ANY WAY ARISING OUT OF OR RELATED TO THIS LIMITED WARRANTY WILL BE LITIGATED IN COURTS HAVING SITUS IN KANSAS CITY MISSOURI PURCHASER HEREBY CONSENTS AND SUBMITS TO THE JURISDICTION OF ANY COURT LOCATED WITHIN MISSOURI THIS WARRANTY SHALL BE VOIDED IF 1 PARTY OTHER THAN A DMS CUSTOMER SERVICE ENGINEER REPAIRS OR REPLACES OR ATTEMPTS TO REPAIR OR REPLACE ANY TRANSPOSAL PRODUCT OR PARTS AND DOES NOT FOLLOW SPECIFIC INSTRUCTIONS PROVIDED BY DMS FOR SUCH REPAIR OR REPLACEMENT OF PARTS OR TRANSPOSAL PRODUCT 15 NOT USED IN ACCORDANCE WITH INSTRUCTIONS PROVIDED BY DMS including water hook ups at hardness levels above five 5 grains per gallon B IS NOT ACCORDED REASONABLE TREATMENT BY THE PURCHASER OR C IS USED IN A MANNER INCONSISTENT WITH THE FOLLOWING TRANSPOSAL ULTRA EQUIPMENT MUST NOT BE USED TO DISPOSE OF ANY SOLID MATERIAL INCLUDING BUT NOT LIMITED TO NEEDLES SYRINGES HARDENED CASTING MATERIAL TISSUE OR ANY OTHER SOLID OR SEMI SOLID SHOULD ANY TRANSPOSAL PRODUCT BE USED IN A MANNER INCONSISTENT WITH THE FOREGOING AND A DRAIN BLOCKAGE OCCURS THE PURCHASER SHALL BE SOLELY RESPONSIBLE FOR THE COST OF ALL REPAIRS OF THE TRANSPOSAL EQUIPMENT AND OF ANY FACILITY DRAINAGE SYSTEMS AND ANY OTHER RELATED DAMAGE Ultra Evac Technical Manual 28 2 8 2013 GD 99013 Rev D
15. Dornoch Medical Systems Inc Transposal Ultra Evacuation Unit Technical Manual Model No UL EV100 Ultra Evac Technical Manual 2 8 2013 GD 99013 Rev D Ultra Evac Technical Manual 2 8 2013 GD 99013 Rev D Ultra Evac Technical Manual 2 8 2013 GD 99013 Rev D Contents Important Information 2 Intended Use 2 Equipment Description 2 User Patient Safety 3 Technical Description Specifications 4 Op ration ea ae Safety Features 7 Environmental Protection
16. PIPE TRAPPED WITH 14 STAND PIPE NOTES EVAC UNIT HAS INTEGRATED BACKFLOW PROTECTION 2 CALL WITH DEVIATIONS OR HELP WITH SPEC 888 466 6633 Figure 9 Ultra Evac Unit Architectural Drawing Ultra Evac Technical Manual 17 GD 99013 Rev D 2 8 2013 De install Disconnect Instructions Please contact DMS at 1 888 466 6633 prior to de installation or re installation of an evac If a Customer de installs or re installs an evac the guidelines listed below must be followed e Always wear personal protective equipment PPE including eye protection and latex gloves to prevent contact with potentially infectious material e Always unplug the unit from the wall electrical receptacle before moving equipment e Wipe down the unit with an approved contact disinfectant after each use Equipment Storage Temperature range for proper storage is 20 C to 40 C If unit is to be taken out of service and stored for a prolonged period of time evacuate water from the hot and cold water manifolds as well as removing the bleach and enzyme solution from their chemical tanks regardless of temperature within storage facility Operation Storage and Transportation 40 C 40 C Temperature 10 20 75 75 d 4 Relative d 4 4 4 Humidity 30 10 1060 hPa 1060 hPa Atmospheric 0 4 Pressure 700 500 Figure 10 Environmental Conditions Ultra Evac Technical Manual 18 2 8 2013 GD 99013 Rev D Maintenance Qualifi
17. Processing Reservoirs Step 1 Insert the coupler into the receiver and gently press the handle down Figure 5 Step 2 Verify that all reservoirs have green lids manifolds and that all of the ports are capped CAUTION Caps must be on all ports prior to washing to prevent wash fluid from leaking out onto the top of the cart during processing Step 3 Follow the on screen instructions to start the processing cycle Step 4 When processing is complete Figure 6 verify the reservoirs are clean If reservoirs are not clean proceed to the Reprocessing Reservoirs instructions below Step 5 Press the REMOVE COUPLER button and remove the coupler by first pressing down gently on the handle and then lifting up while pulling the coupler out of the receiver Place the receiver in the storage unit CAUTION ALWAYS press down gently on the handle prior to removing the coupler Failure to do so could cause damage to the equipment Reprocessing Reservoirs Optional Step 1 Access the reprocessing options by pressing the OPTIONS button in the upper right corner Figure 6 Step 2 Select the desired reservoir s and the cleaning cycle and then press the START PROCESS button to perform the selected cycle Figure 7 See Reprocessing Cycle Descriptions Prepare Cart for Next Case Step 1 Remove the used lids manifolds from each reservoir and discard according to hospital policy Processed lids
18. ansposal Product has been shipped by DMS And for any Transposal Product which does not such installation the Term of this limited warranty shall begin three 3 days after the date the Transposal Product has been shipped by DMS Any replacement part including a user installed part that has been installed in accordance with instructions provided by DMS is subject to this limited warranty for the period remaining in the Term for the subject Transposal Product NOTWITHSTANDING ANYTHING TO THE CONTRARY DMS DOES NOT WARRANT ANY OF THE FOLLOWING THAT MAY BE SHIPPED WITH OR AN INTEGRAL PART OF ANY TRANSPOSAL PRODUCT OR SUPPLIES REQUIRED TO OPERATE OR INSTALL ANY TRANSPOSAL PRODUCT ITEMS AND PRODUCTS NOT MANUFACTURED BY DMS INCLUDING BUT NOT LIMITED TO ENZYMATIC CLEANER TUBING AND ANY BACKFLOW PREVENTER ID ITEMS AND PRODUCTS DESIGNED FOR SINGLE USE INCLUDING BUT NOT LIMITED TO CANISTER LIDS AND CART LIDS AND ITEMS AND PRODUCTS IDENTIFIED AS CONSUMABLE CONVERSION SUPPLIES ON A PURCHASE AGREEMENT OR TRIAL AGREEMENT ENTERED INTO IN CONNECTION HEREWTIH DMS liability shall be limited at its sole option and expense to repair or replace during DMS normal service hours any Transposal Product which has been examined by DMS and found in the sole discretion of DMS to be defective The maximum liability of DMS to any person whatsoever arising out of or in connection with the sale or use of its equipment whether such liability arises from a
19. ater to help break up any clots that may be remaining in the bottom of the reservoir at the end of the cycle Let the fluid soak for at least one hour for best results Pull Soak Cycle fills reservoir to the 13L Quad or 16 5L Duo mark along with about 10 ounces of enzyme This cycle is used if there are spots on the reservoir that not coming off during a wash Let the fluid soak for at least one hour for best results Rewash Cycle will attempt to clean the selected reservoir s again using wash water and enzyme The cycle will apply the solution and pause several times during the rewash cycle Performing Verify Bleach Cycle To verify that the unit is applying bleach place the unit into the check for bleach mode by using the following steps Hook a cart to the evac Press the button to confirm the lids are on the reservoirs On the second screen press the options button in the upper right hand corner Select Bleach Check and press the Start Process button The cart will process through bleach application and will give instructions on the screen Remove a test strip from its container Ss qe Um or Remove the lids and touch one end of the test strip to a droplet on the bottom of the first lid and use the other end of the test strip to touch a droplet on the bottom of the other lid 8 purple test strip indicates a pass Any other color indicates a failed result 9 Replace the lids onto the reservoi
20. cations for Service Personnel Service personnel will be trained during the installation of the equipment on preventative maintenance troubleshooting and common problems Support for the service technicians is always available by calling Customer Service at 1 888 466 6633 Qualifications needed to properly service products manufactured by DMS in no way allows for or authorizes any person to avoid the authorities with jurisdiction to impose additional requirements for qualifications on service personnel DMS recommends that all facilities service and healthcare professionals attend the Maintenance amp In Service Training sessions offered during the time of equipment installation All maintenance to be performed by qualified personnel only Repairs by unauthorized individuals should not be attempted and may result in damage to or malfunction of the system or even personal injury Service Warnings A WARNINGS Modification of this equipment is not allowed When performing any service or maintenance procedures on the cart follow all manufacturers instructions Handling biohazard waste is potentially dangerous Wear personal protective equipment when servicing the cart Prior to performing any maintenance on the evac unplug the unit from the wall outlet Not unplugging this unit will leave dangerous voltages amp current accessible to the service personnel working on or in this machine NOTE If the unit is to be moved w
21. d below Figure 9 presents an architectural drawing of site requirements Please use these figures as a reference for proper site preparation Ultra Evac Technical Manual 15 2 8 2013 GD 99013 Rev D Utilities Needed for Installation Table 2 Site Utilities for Installation Power 120VAC 60Hz 15amp Water Supply 3 4 Hot and Cold 5 0gpm 18 9lpm 55psi Water Temperature 100 115 F 38 46 C Drain 1 2 2 Space 24 61 W x 20 51 D x 33 84 H Space The Ultra Evac Unit installation site must be a minimum of 24 61cm W x 20 61cm D x 33 84cm H The Ultra Evac Unit must be installed no less than 6 inches 15cm from the wall to accommodate operator access to the unit s main power supply wall outlet Water Supply The Ultra Evac Unit requires a hot water supply running at a minimum of 5 0gpm 18 9lpm and 55psi Hot water temperature should be between 100 115 F 38 46 C Hard water in excess of 5 0 grains per gallon can adversely affect equipment operation Consequently hard water must be treated before it enters installed equipment Untreated hard water supplies will void equipment warranties A 3 4 supply is desirable because of the volume of water it carries but a 1 2 line is usually sufficient as long as the facility has good water pressure 55 psi or higher at the unit Hot supply pipe should run up or down the wall to the left side of the space where the machine will be instal
22. e DMS UL BW100 Clorox Germicidal Wipes or equivalent and place clean lids onto the cart Non approved wipes may cause surface damage to the equipment Bleach Verification Daily visual verification of the cart evac systems bleach cycle shall be completed using a Verification Log Kit FTP VL100 Continuous automatic monitoring of the bleach cycle is accomplished with electronic sensors within the evac If an error is detected the message shall be reported to an immediate supervisor Single Use Items Storage A supply of new single use reservoir lids or manifolds shall be kept in a designated clean storage area and near any point of use Preparing Reservoirs for Use A new single use lid TP DL2800 or manifold UL CL500 shall be placed onto the reservoir in a designated clean area The user must verify the white hydrophobic filter is in place on the lid or manifold If it is the first case of the day or the cart has just been processed verify the reservoirs are clean prior to installing a new single use lid Cart Cleaning Ultra Fluid Carts should be processed when all of the collection reservoirs have been used or at the end of the day Cart Transportation Used carts shall be sealed and transported to the evac for processing Before processing the cart verify all of the ports on the single use lids or manifolds are capped Ultra Evac Technical Manual 8 2 8 2013 GD 99013 Rev D Instructions for Use
23. erform recommended maintenance as indicated in these instructions Only trained and experienced health care professionals should maintain this equipment No user serviceable parts inside the unit Contact Dornoch Medical Systems Inc customer service if an issue arises Only authorized service personnel should open any of the access covers on this equipment User operation does not require access to these areas Ultra Evac Technical Manual GD 99013 Rev D ALWAYS use the handle to move the cart DO NOT push pull the cart by grasping any receptacle or the outer surface NEVER hang any heavy object from the cart handles ALWAYS have more than one person unpack and lift the equipment off the shipping pallet No incline planes of operation DO NOT use the system if leakage of surgical fluid waste occurs Disconnect power immediately and call Dornoch Medical Systems Inc customer setvice DO NOT allow fluid of any kind to spill directly onto the extetior surface of the electrically powered evac DO NOT use the evac until it has been installed and tested for proper operation This unit uses both bleach and enzyme in its operation When replacing bottles always wear the appropriate Personal Protective Equipment Use only Dornoch Medical Systems Inc approved Bleach and Enzyme to avoid damage to the system components This equipment is not suitable for use in the presence of flammable anesthetic mixtures with air
24. euse Once installed operators simply connect the evac to a dirty cart with the evac s coupler With a touch of a button the cart is automatically emptied cleaned and rinsed With the addition of a new single use lid they are ready for reuse within the facility Ultra Evac Technical Manual 2 2 8 2013 GD 99013 Rev D User Patient Safety A WARNINGS Before using this system read and understand the information in this manual DO NOT use this system outside the scope of the defined indications for use Upon initial receipt and before each use operate the equipment and inspect each component for damage DO NOT use any component if damage is apparent Handling biohazard waste is potentially dangerous ALWAYS follow current local regulations governing biohazard waste to safely handle and dispose of surgical fluid waste The Blood borne Pathogens Standards provided by the Occupational Safety and Health Association OSHA requires that all workers having exposure to potentially infectious materials should wear the correct personal protection equipment To avoid the risk of electrical shock this equipment must be connected to electrical outlet with a protective earth ground Verify all access doors are securely in place before operating this unit Use only Dornoch Medical Systems Inc approved accessories Do not connect items to this system that are not designed for or specified for use with this system P
25. factured and shipped from a centralized facility and supported by a nation wide sales force The company s principals include individuals with extensive backgrounds in product development management production and sales of medical surgical products Jim Dunn a successful inventor who served as an operating room nurse for 20 years helped design DMS products Contact Information Dornoch Medical Systems Inc Shipping Address 200 NW Parkway Riverside MO 64150 Office Correspondence P O Box 681656 Riverside MO 64168 Toll free 1 888 466 6633 Phone 1 816 505 2226 Fax 1 816 505 1050 Web www dornoch com Ultra Evac Technical Manual 26 2 8 2013 GD 99013 Rev D Limited Warranty Dornoch Medical Systems Inc hereinafter DMS warrants each new Transposal Product as listed in the Transposal Product Guide published by DMS from time to time which is identified as capital equipment on the Purchase Agreement or Trial Agreement entered into in connection herewith to be free from defects in materials and workmanship under normal use and service for a period of one 1 year from the date of installation the Term Both parts and labor are covered for the one year period per the conditions below Notwithstanding the foregoing if any Transposal Product requiring installation is not installed by a DMS Customer Service Engineer the term of this limited warranty shall begin 14 days two weeks after the date the Tr
26. ipe down the outside of the unit with a hospital approved bleach wipe Sani Cloth Bleach Germicidal Wipe DMS UL BW100 Clorox Germicidal Wipes or equivalent NOTE Remove all fluids from the bottom of the unit s lower cabinet before returning equipment to setvice Additional Information Upon request DMS will provide the following Circuit Diagrams Component Parts List Description of Components Calibration Instructions and any parts information needed for repair of the unit Ultra Evac Technical Manual 19 2 8 2013 GD 99013 Rev D Routine Maintenance Front Panel Removal Call DMS at 1 888 466 6633 prior to removing or servicing any components that require the front panel to be removed Removal of the front panel will allow access to the electrical components underneath Once removed the possibility of electrical shock is present Use caution when performing any service to these components To take of the front panel remove the two screws on either side of the green top and raise the top Remove the two screws on either side of the front panel near the bottom of the unit at the back edges of the panel Lift the panel up and out to remove Note This panel has a ground wire attached to it Inspections Regularly visually inspect the unit for any signs of damaged or leaking components If any problems are found contact Customer Service at 1 888 466 6633 to report findings Replacement Items Power Supply There is not a subs
27. is also one located on the ground wire from the coupler Functional Earth Ground Symbol This label is used to symbolize a functional earth ground They are located near all functional grounds Electrical Requirements and Serial Number Label Located on the back of the unit upper right corner as facing the back Information contained on this label Dornoch contact information serial number ETL compliance information electrical information and patent information Dornoch Medical Systems Inc 200 NW Parkway Riverside MO 64150 Serial Number www dornoch com 888 466 6633 This equipment complies with and is Listed under the IEC 60601 1 278 Edition Standard for a Class 1 Medical Device Ultra Transposal Evacuation Unit 115 120 VAC 60 Hz Nominal 0 2 6 0 A Momentary Peak 8 8 A This equipment complies with and is approved for use under IEC 60601 1 General Requirements for Safety IEC 60601 1 1 Safety Requirements for Medical Electrical Systems IEC 60601 1 2 Electromagnetic Compatibility Requirements and Tests IEC 60529 rating certification of IP41 Patent Pending Operating Instructions Located on the back of unit Pove coneco mast dts near the power cord The label is used to instruct the user to the manuals as well as inform them of the power outlet a Hospital Grade power receptacle only requirements of the unit Waste Label This label is used to identify the waste line
28. led ending 48 122cm to 58 148cm from the floor Attach a threaded 2 FPT ball valve to the end of the supply pipe Electrical The unit s electrical supply must be within 36 92cm of the unit location A ground fault receptacle rated at 120 VAC single phase at 60 Hz and 15 amps is required The Ultra Evac Unit draws a peak current of 8 8 amps with a normal operating current draw of 0 2 to 6 0 amps Sanitary Sewer Drain The Ultra Evac Unit requires a 1 1 2 to 2 PVC or copper sanitary sewer drain connection The ideal drain is centered on the install site 6 15cm to 15 38cm from the floor and has an attached trap The drain can protrude vertically out of the floor or horizontally from the wall Drainpipes brought up through the floor should stay as close as possible to the wall Wall drains should not protrude more than 6 15cm from the wall The drain shall be trapped and have a 16 40cm long standpipe A mop sink or hopper may be used in lieu of the above specification Backflow Preventers The Backflow preventer is integrated into the Ultra Evac Unit It requires no drain hook up Consult local regulations for specific requirements Ultra Evac Technical Manual 16 2 8 2013 GD 99013 Rev D 172 TO 3 4 LINE 5 0 GPM 55 PSI MINIMUM BALL VALVE WITH 1 2 FNPT TO CONNECT 120 VAC 15 AMPS GFCI CIRCUIT LOCATION WITHIN 3 FEET OF UNIT TO LEFT OR RIGHT REQUIRED SPACE THROUGH WALL 1 2
29. manifolds can be identified with a blue filter Step 2 Wipe down the cart with a hospital approved bleach wipe Sani Cloth Bleach Germicidal Wipe DMS UL BW100 Clorox Germicidal Wipes or equivalent Step 3 Move the cart to a clean area and replace the lids manifolds Ultra Evac Technical Manual 9 GD 99013 Rev D o Figure 5 Coupler Insertion DISPOSE OF LIDS AND WIPE DOWN CART PRESS TO REMOVE COUPLER Figure 6 Cycle Complete Screen SELECT CYLINDERS EXIT SELECT CLEANING CYLINDER2 3L SOAK CYLINDER3 FULL SOAK CYLINDER 4 REWASH START PROCESS Figure 7 Cleaning Cycles Screen 2 8 2013 Replacing Bleach amp Enzyme Bottles Evac Station bleach and enzyme bottles must be replaced when indicated on the cart s display during processing Bottle replacement is completed as follows CAUTION ALWAYS use approved enzymatic cleaner and fresh Clorox bleach when replacing chemicals Clorox bleach slowly looses strength over time Other chemicals may damage the evac and cart Figure 8 Bleach and Enzyme Bottles Step 1 Remove lid and pickup tube from empty container Figure 8 Step 2 Open a new bottle place the bottle into the top of the unit insert the pickup tube into the bottle and secure the lid Step 3 Dispose of the empty bottle pet hospital policy Reprocessing Cycle Descriptions 3L Soak Cycle applies 10 ounces of enzyme with 3 liters of w
30. nding of the equipment s operation and the maintenance procedures needed If required DMS service personnel can be contacted 24 hours a day at 1 888 466 6633 Ultra Evac Technical Manual 1 2 8 2013 GD 99013 Rev D Important Information Please read this manual and follow all instructions The words WARNING CAUTION and NOTE have special meanings and should be reviewed WARNING _ Disregarding WARNING information may compromise the safety of the patient and or health care staff and may result in injury CAUTION Disregarding CAUTION instructions may compromise product reliability and may result in damage NOTE NOTE information supplements and or clarifies procedural information A triangle with an exclamation point alerts the health care professional to read and understand the accompanying instructions especially the operating maintenance and safety information Intended Use The intended use of the evac is to process the carts after they have collected surgical fluids The evac will empty clean and rinse the reusable suction reservoirs on the carts Equipment Description The evac is a standalone unit that can automatically process a cart The evac empties cleans and rinses the carts during the process The Ultra System significantly reduces employee exposute to potentially infectious body fluids while eliminating up to 70 of Operating Room red bag waste The evac processes Ultra Duo and Ultra Quad carts for r
31. oxygen or nitrous oxide Is not intended for use with AP or APG equipment Hot Water Temperatures higher than 118 F can cause damage to the unit There are no known significant risks of reciprocal interference posed by the presence of this equipment or its operation in either the operating room suites or other areas when used during specific investigations and or treatments There are no known potential electromagnetic or other interferences between this unit and other devices located and or operated within the area of the operating room suites 2 8 2013 Technical Description Specifications Table 1 Equipment Specifications Item Ultra Evac Unit HUL EV100 Certifications ETL Listing Class 1 Medical Device Complies with the following 60601 1 General Requirements for Safety 60601 1 1 Safety Requirements for Medical Electrical Systems 60601 1 2 Electromagnetic Compatibility Requirements and Tests s IEC 60529 rating certification of IP41 FDA 510K certification CAN CSA Standard C22 2 No 601 1 FDA Registration 1954182 Patents Patent Pending Installation Fixed Size inch cm 20 51 W x 16 41 D x 28 71 H Weight Ibs kg 100 46 Utilities Power 120VAC 60Hz 15amp Water 3 4 Hot and Cold 5 0gpm 18 9lpm 55psi Hot Water Temperature 100 115 F 38 46 C Drain 12 2 Space
32. roper usage of single use items poses a health risk to patients and health care providers Ultra Evac Technical Manual 14 2 8 2013 GD 99013 Rev D Installation Protective Packaging amp Unpacking WARNING ALWAYS have than one person unpack and lift the evac off the shipping pallet Special measures are needed for and during transport of the unit Ultra Evac Units are equipped with four adjustable legs Ultra Evac Units should be put on a cart or dolly for transporting during installation de installation Adjustable legs are adjusted to level the unit during installation To obtain information on transporting and temporary storage considerations call DMS at 1 888 466 6633 Premature unpacking of the Ultra Evac Units could risk damage to or loss of the installation items that may be sent with the unit Contact customer service if unpacking the unit is necessary Site Preparation A DMS Installation Technician is responsible for the physical hook up on site quality control testing and the initial start up of Ultra Evac Unit equipment Customers responsible for preparing the equipment space and utilities at the installation site All equipment sites must be prepared in accordance with the requirements described here at least seven 7 days prior to scheduled system installation This section outlines the general and specific site preparation requirements for space water drain and electrical needs are presente
33. rs and press the button on the screen to complete processing 10 If the test strip turns purple the canisters are having bleach applied to them 11 If the test strips do not turn purple call DMS at 1 888 466 6633 and ask for service Ultra Evac Technical Manual 10 2 8 2013 GD 99013 Rev D Unit Information and Error Messages The cart display provides the operator feedback for common operating errors encountered during the evac processing cycle The most common messages are described below Please call DMS at 1 888 466 6633 for assistance with any error message Warning or Error Action Required Leak Detected This message indicates that there has been a leak detected within the evac The unit alarms at the end of the cycle when cart has completed the cleaning process Check all supply lines for correct connection Call service if necessary Replace Bleach This message indicates that the unit has run out of bleach The unit alarms at the end of the cycle and when replaced will go back and apply bleach to the reservoirs as necessary Replace the bleach with a new gallon Replace Enzyme This message indicates that the Enzyme solution has run out The unit alarms at the end of the cycle when the reservoirs have completed the cleaning process Replace the enzyme with a new gallon Valve Error This message indicates one of the evac valves is not operating properly The error displays after the reservoi
34. rs have completed the cleaning process Contact service with the specific valve error Communication Error This error indicates that the cart and the evac are hooked together but there is no data transfer between the two Uncouple the evac from the cart Wipe the contacts on the coupler and in the receiver with alcohol and try to hook them together again Call service if the problem continues Periodic Maintenance Interval Activity equipment if damage is present Prior to each use Inspect the coupler hose for twisting or any leaks in the hoses Inspect the coupler housing for any cracks or other defects that may affect function DO NOT use if the required As required Check the level of the enzyme and bleach in the bottles Replace the bottles as Ultra Evac Technical Manual 11 GD 99013 Rev D 2 8 2013 Troubleshooting Guide Problem Unit Will Not Operate Possible Solutions 1 Check that the machine is plugged into an operational outlet 2 Call maintenance to replace the Unit s internal fuses Problem Coupler Engages but Cart Will Not Power Up Possible Solutions 1 Remove the coupler and try again 2 Clean the electrical contacts with a cotton swab and alcohol Try to activate the cart again 3 Call DMS at 1 888 466 6633 Problem Chemical Flow Error Even With New Gallons Possible Solutions 1 Tighten connections on the pickup tubes in the chemical bottles
35. titute power supply replacement The power supply must be replaced with the following e Manufacturer Condor e Model GLM75 Medical Contact DMS for replacement parts at 1 888 466 6633 Replacement Fuses Two sets of replacement fuses are located on the main circuit board Fuse specifications are as follows e Fuse replacement for the main ICB power 250V 5A time delayed fuse e Fuse replacement for the drain pump 250V 8A time delayed fuse Power Cord Replacement Contact DMS for replacement only see components part list Procedure for replacement correct connection amp anchoring are provided with the replacement power cord Ultra Evac Technical Manual 20 2 8 2013 GD 99013 Rev D Fluid Paths and Wiring Diagrams Hot Water Supply Master Valve Bleach Enzyme Wash Valve Reservoir Reservoir Clog Buster Valve Flow Sensor Evacuation Pump Ultra Cart Waste Evac Wash Manifold Facility Drain Ultra Cart Wash Figure 11 Ultra Evac Unit Fluid Flow Diagram Ultra Evac Technical Manual 21 2 8 2013 GD 99013 Rev D dois 1 Hep plousjos jejdno5 105095 xoJd Je dno3 Dn 4508 41n ccs Dnld e es seco TL Bnid e ees MO ecccsecscceccssssececc Jejsng 50915 966022985090990090062099992900 Ob OVA qN3531
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