UltraFlex Duo Cart Instructions For Use
Contents
1. Calibration Instructions and any parts information needed for repair of the unit Ultra Cart Technical Manual 21 2 8 2013 GD 99021 Rev E Routine Maintenance Lower Panel Removal Remove the two blue wheel skirts one on each side by pulling them straight up and then out Remove the screws that hold the panels onto the cabinet and pull it back a small amount to gain access to the ground wire Unhook the ground wire that is attached to the panel and then lift the panel off to completely remove Access Panel Contact DMS at 1 888 466 6633 prior to removing or servicing any components that require the access panel to be removed Removal of access 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 The panel is located on the back of the unit Note This panel has a ground wire attached to it Inspections Regulatly 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 substitute 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 Fus2. GD 99021 Rev E 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 or death CAUTION Disregarding CAUTION instructions may compromise product reliability and may result in damage NOTE NOTE information supplements and or clarifies procedural information d 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 cart is to collect surgical fluids in a reusable suction device that can then be emptied cleaned and rinsed while providing suction independent of the facility s wall soutce Equipment Description Carts collect up to 52 liters of surgical fluids without the need to tandem multiple suction canisters In addition the cart s on board suction assist pump improves or replaces facility wall vacuum when inadequate suction is otherwise present The cart significantly reduces employee exposure to potentially infectious body fluids while eliminating up to 70 of Operating Room red bag waste The cart contains either two 16 5 Liter reservoirs or four 13 Liter reservoirs which are processed using an evac The multiple re
3. QD500 Only Figure 21 Ultra Fluid Cart Vacuum Flow Diagram Ultra Cart Technical Manual 23 2 8 2013 GD 99021 Rev E Reservoir 1 Reservoir 1 Vent Reservoir H1 Wash Reservoir H1 Waste Y Reservoir 113 Vent Valve Pack 1 2 Opens Wash Waste and Vent Valves to either Ultra Evac Reservoir 3 Reservoir 3 Waste Y Reservoir H3 Wash Unit Wash Ultra Evac Unit Waste 4 Reservoir H2 Wash Reservoir H2 Waste Reservoir 112 Ultra Cart Technical Manual GD 99021 Rev E reservoir or closes all valves u Atmosphere for Vent Valve Pack 3 4 Opens Wash Waste and Vent Valves to either KE reservoir or closes all valves Reservoir 112 Vent Reservoir 4 Waste T Reservoir 4 Wash J Reservoir 4 Vent Figure 22 Ultra Fluid Cart Fluid Flow Diagram 24 Reservoir 4 QD2800 amp QD500 Only 2 8 2013 JOSU3S uonisod US JOSUSS uonisog 1uDnj 91929 UO s m 90 9DejjoA MO eeesecssceccccoccccccecoce IVA OCT JINYM 499594909 999659995950 9959 972599 2999 206089 bb Bnid SIN
4. Volume Not Displayed on Screen Possible Solutions 1 Level Sensor not calibrated or defective 2 Call DMS at 1 888 466 6633 Problem No Suction or Inadequate Suction Possible Solution 1 Verify that new single use lids have been installed The single use lids and manifolds are each equipped with a hydrophobic filter that will close when it becomes wet If the unit was processed and the lids have not been replaced this will block suction at the patient ports 2 If using the cart not attached to wall suction verify that the suction pump has been turned ON 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 Cart Technical Manual 16 2 8 2013 GD 99021 Rev E Symbols amp Labels The explanation and location of all Labels Safety Signs Symbols and Displays used on the eq
5. 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 or manifolds New lids are pressed on to the top of cart reservoirs or 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 end of every day Figure 3 TP DL2800 Single Use Lid Cart processing is accomplished with an g evac Figure 5 located in an OR utility closet or decontamination room Evacs 2 empty clean and rinse reservoirs for reuse The evac s water drain and Figure 4 UL CL500 Single sensor lines are easily connected to the Use Manifold cart using a drip less all in one coupler connection Carts are powered by the evac coupler connection during reservoir processing Figure 5 Ultra Fluid Cart Connected to the Ultra Evac Unit Ultra Cart Technical Manual 6 2 8 2013 GD 99021 Rev E Safety Features The carts have numerous built in safety features including e Closed System Design The carts are designed to confine and contain fluids during collection and disposal of s
6. verify the reservoirs are clean prior to installing a new single use lid e 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 e Cart HEPA Filter HEPA Filter must be replaced by approved DMS Filter When replacing HEPA Filter it should be treated as potentially hazardous material and disposed of accordingly Ultra Cart Technical Manual 8 2 8 2013 GD 99021 Rev E Instructions for Models DU2800 amp QD2800 Fluid Collection Step 1 Verity fluid reservoirs are empty and clean Ensure the unit is equipped with new single use lids Figure 7 NOTE The volume of the pre fill fluid in the reservoir is accounted for in the displayed volume on the cart s touch screen Step 2 To prevent inadvertent movement of the cart lock the caster Plug power cord into a wall outlet and verify that it is also plugged into the cart Turn the power switch to the ON position Figure 6 Step 3 Attach cart vacuum line adapter to the Vacuum Supply port on the single use lid Figure 7 NOTE If cart vacuum is manually regulated proceed to the Manually Regulated Models section Step 4 Duo Cart Turn reservoir vacuum ON or OFF by pressing the desired reservoir icon on the cart s touch screen Figure 8 Step 4 Quad Cart Turn reservoir vacuum ON or OFF by pressing the desi
7. Ee lee EE EES 16 DMS Technical Service gt INTO mation ESS nee Rene 16 c Ng Ble oe E C LT re ce re cere once ae eee an cee D nee ce E D DID D DC cere cere 17 EUREN 18 Instalator 19 Protective Packaging El Ter Tee 19 SIGE Preparato CDL E 19 D S OIL DIscorect Inst le dene 19 Equipment Storage sestiere A eed e eee reer ees ae 20 SA SAR ae 21 Oualiticadors TOL Service PERSONNES ER 21 SEVICE Warnings ARR EE Lc LE 21 Ultra Cart Technical Manual 2 8 2013 GD 99021 Rev E Additional IA OPA TONER sese a oe SR ee 21 ROUtINe Maltenahces SR SR SR ESS ee sears se ESS En Es 22 REECH 22 Huic Paths a a Wiring Diagial cuneo eee ee 23 EENEG Eeler 28 Company EU 29 LIMIESS Warranty ssc see ee ee 30 List of Tables Table 1 EguipmenbspecificdtlOlIS curtir ved cipi tradi s tune iR E xev Oye cou add dada ce ten VR E ki E DESEE art 4 Table 2 Preventative Maintenance Schedules asian us aaa na QU ve XO ca c cR Ra a EE 28 List of Figures Figure 1 Ultra Duo Cart Dimensions and Features Dim inch cm 5 Figure 2 Ultra Quad Cart Dimensions and Features Dim inch cm 5 Figure 3 TP DL2800 Single Use daa UE ee ACE ROLE RO ROC FUGERE 6 Figtire 4 UL CL500 Single Use Mafifoltds cost vis vsu y DER SERRE aman ven QUT SEP amar SERE ER VE a 6 Figure 5 Ultra Fluid Cart Connected to the Ultra Evac Unit ecce 6 Figure p Power CONG iG WIESE socio nt op S ora DON URNA D D Us v RE 9 Figure Vacuum Adapter arr Lid usse gp
8. Z LIOARSOY eno TH Bid s1y n T HIOA RSS esssst00ccvosssssacesseseeeceseeeceeoe Ob Bnid c Jonas winnseA eecccs 6b4 Dn d I Jo3e nba34 WAND A 9 999999999979999999 9 9 999 999 e Sb 5Bnid SALA Jolley LTA eososevoscesssscecescececccosseceeee OTA DNid Z 2AJPA MOL UDIH tt Nid T 9A BA MOL UDIH vossssosocesesccoececcceccecccecceee c Meld 2AJPA unnoeA DT K Dn T SARA LUISA osscssco vassseceonsaovseceecevecesedIIj Bnid 39 4839 JOYUO y A LR Dn JOosueS eunjeJeduie L Sssgsggsgsgegssgegsgsgegeeggegggeggsgegeeeeg rd Bnid ES ee dere Sn 9 9 T I0A J9533 escsedp T4 DM PAST Z JIOASOY ss dt L BNid uey Suloo 3 DM eC Lee onu Uld 6 Ajddns J2MOd 990990900900000992290004909209000922920 9C PH Dn ld S Aj ddns Jamog Figure 23 Ultra Duo Cart Electrical Wiring Diagram 4030 4 ped SALA 99 9 9 999999 99 9 97999 9 9 9 9 999 99 9 9 99509990999 9909099099995990999995 Bnid 121 JOSU3S uonisod LUNNIBA kees M n LUNNIBA 9 r n v o c Bnd WD 2INPOW 191 13MOJ URW mo DM T4 pyeog 043u0 x2ed BAJLA peog IOW 2 8 2013 25 Ultra Cart Technical Manual GD 99021 Rev E B92 UOQOS a p mx 30 26e J0A MOT eecccccccececcsecvecces OVA OCT m dN3511 o APY MI 9 0909900500909999900990090902090202s9 DpH End S UDr p JIOA SSH eccccc 6t4 Dn d SIYDN E HIOASSS e000000020000050040000602 ccc0cccccc
9. agents ALWAYS use the handle to move the cart DO NOT push or pull the cart by grasping any other part of the outer surface NEVER hang any heavy object from the cart handles No incline planes of operation ALWAYS follow reservoir overfill alarms to prevent overfill DO NOT use the system if leakage of surgical fluid waste occurs Disconnect power immediately and call Dornoch Medical Systems Inc Customer Service DO NOT allow fluid of any kind to spill directly onto the exterior surface of the electrically powered cart DO NOT use the cart until it has been tested properly and the Evac Unit has been installed and tested properly 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 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 ate no known potential electromagnetic or other interferences between this u
10. bf Dnid s ybr Z oa SSH 194 Dn d SIUBN T J1OAJ9SIY eeccocsesccnccscesccccesescenesessesl O y DD b IALA M0 J UBIH 1p04 DM E SALA MOY ubiH sessoovecessseccecessceceeececce C A Nid SAPA MOH YIH eeee Z0 D T 9AJE A MO UDIH essseveocecsecssocesseccseseosccese ICA Bnid Dog 19130 4 0 po1unoy pie0g 19146neq p JOJe IND3Y uunn2eA d9p Dn 9 9 9 9 9 9 v o v voon v eot Gps Bnid c JojyejnBay LUNNIBA eesseelGbH Dn d T 40je nb234 unn2eA 99090900a904009000228400900002220990202229 QE nid J030 4 Yd SIAPA DADA SARA Jolley LUNNIBA s9 990990205990902504290909922022909002s2s OT Bnid p AJLA LUNNIBA ao bi nid E AJEA LUNNIBA OTT e nid Z MAPA Uinn2eA ATA Bnid T 9A BA LUNNIBA 99049909400909090090090090004609 9002999 Bnid 3 49 81195 JOU sescesssssesccecesescccecceececcecceece OCA Dn d BEE DE SEE Josues aJ4njeJeduie TEE KZ Dh d ER HEES Jees el6T DO BEZGEEZLLINEM ss ssssssssssssncssesssscsses J2T DO 2 9 P JIOoAJosau Sesggssggsgeesegegegeggesgggggegeeesgeg II Bnid Doud 1010 BAILA JosuaS Uuonisog 971 B899498890902299429284294429984992224 Bnid y Josues uonisog WNMEA Bnid WNNseA JOSUSS UOQISOd 14DIy 99640090099006000909099400920992499 Bnid 45y TH p1eog 01 U09 Ped INLA J0 0W JPEG ALA AAA 0 JOSU3SS UONISOS Ya LOErrrnnsrrrrsrnnrssr nn e Bnid 91 Josues uomnisogd LUNNIBA TIT Bnid VINNIBA JOSU3IS UOQISO d 1ubni 99
11. occlude the Patient or Tandem ports Single Use Cart Manifold UL CL500 The single use manifold has three suction ports Any one of these ports and up to three can be used to collect fluids The suction ports are not labeled and are all the size of a standard Ortho port Single Use Lids and Manifolds d WARNING Both the TP DL2800 lid and the 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 Improper usage of single use items poses a health risk to patients and health cate providers Disposable Suction Tubing Provided by the Hospital Any surgical suction tubing of variable diameters sterile or unsterile can be used to attach to single use lids manifolds Most suction tubing has flexible boots on the ends to accommodate different diameter suction ports or surgical devices CAUTION Do not connect items that are not designed for suction systems as a safety hazard may result Ultra Cart Technical Manual 13 2 8 2013 GD 99021 Rev E Early Warning and Overflow Protection System The cart will alert the user when the reservoir is a 1000mL from full capacity and will do the following to avoid an overfill situation Reservoir will no longer be active and the vacuum will automatically shut off Reservoir will automatically v
12. then suction tubing connected to the top of the trap e UL CB100 Ultra Clot Buster Specially formulated chemical to either prevent clotting during a rich blood procedure or to break up any clots found during processing of the cart e UL BW100 Sani Cloth Bleach Germicidal Wipe approved surface disinfectant wipe for the carts Ultra Cart Technical Manual GD 99021 Rev E 18 2 8 2013 Installation Protective Packaging amp Unpacking A WARNING ALWAYS have more than one person unpack and lift the cart off the shipping pallet Special measures are needed for and during transport of the unit Carts Duo and Quad are heavy and should only be lifted using all three handles The reservoirs must be emptied prior to lifting the unit or personal injury could occur Each cart is equipped with four casters Carts must be rolled into out of the area they will be used during installation de installation To obtain information on transporting and temporary storage considerations call DMS at 1 888 466 6633 Premature unpacking of the cart could risk damage to or loss of the installation items that may be sent with the unit Contact Customer Service at 1 888 466 6633 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 cart No specific site preparation is required for the cart De install Disconnec
13. vacuum can be higher than 700mmHg 52 000mL 6 000mL maximum fluid capacity Dornoch enzyme solution and Clorox bleach are used to clean the collection cylinders of the Ultra Fluid Cart Ultra Cart Technical Manual 4 GD 99021 Rev E Ultra Duo HUL DU2800 UL DU500 ETL Listing Class 1 Medical Device Complies with the following IEC 60601 1 General requirements for safety of medical equipment devices m IEC 60601 1 1 Collateral Standards for Medical Equipment IEC 60601 1 2 EMC amp RFI compliance testing standatd IEC 60529 Degrees of protection provided by enclosutes m FDA 510K Certification K081047 ISO 10079 1 Medical Suction Equipment electrically powered suction equipment FDA standard for hospital suction systems CAN CSA Standard C22 2 No 601 1 1954182 Patent Pending Mobile 24 61 W x 24 61 D x 55 140 H 195 88 empty 268 122 full 115 120V AC 60Hz 4 5 amp None Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or with nitrous oxide Connected to the facilities main vacuum system or as a standalone device Continuous High Vacuum High Flow maximum vacuum level obtainable is 0 700mmHg Measured with all ports closed If connected to hospitable suction obtainable vacuum can be higher than 700mmHg 33 000mL 6 000mL maximum fluid capacity Dornoch enzyme solution and Clorox bleach are used to clean the collection cy
14. 4 675 CYLINDER 2 602 mmHg E 33 5 12120 2 8 2013 Models DU500 amp QD500 Fluid Collection Step 1 Verify fluid reservoirs are empty and clean Ensure the unit is equipped with new disposable manifolds Figure 10 NOTE The volume of the prefill fluid in the reservoir is accounted for in the displayed volume on the cart s touch screen Step 2 To prevent inadvertent movement of the cart lock the caster Plug power cord into a wall outlet and verify that it is also plugged into the cart Turn the power switch to the ON position Step 3 Attach cart vacuum line adapter to the Vacuum Only port on the single use manifold Figure 11 Step 4 Duo Cart Turn reservoir vacuum ON or OFF b p y pressing the desired reservoir icon on the cart s touch screen Figure 12 Step 4 Quad Cart Turn reservoir vacuum ON or OFF by pressing the desired reservoir icon under the Light buttons on the cart s touch screen Figure 13 Step 5 Verify suction at a manifold port Figure 11 Vacuum Adapter Manifold Step 6 Load any required IV fluid onto the optional IV pole Do Se Cover P not load more than 6000mL of IV fluid on the provided IV pole Step 7 Attach patient tubing to manifold port s Warnings DO NOT apply High Flow suction ot allow extended exposure of suction to the tissue associated with procedures that require either no suction low vacuum of low flow suc
15. 6955499900 58249949905989092909925 Bnid 145r T p1eog 0 3005 ype AJLA paeog 19 3014 Figure 24 Ultra Quad Cart Electrical Wiring Diagram 2 8 2013 26 Ultra Cart Technical Manual GD 99021 Rev E CYL CYL eil d CYL Bolten Altea Maltes SO Era s 43714101 11435 Snead VAC REGS Har REGS Ultra Cart Controller m _ 14 744R1 e 2909 Dornoch Medical Systens Inc A GAST Non DL did eade s FRESSED AYR JTAG Push IW DES 2 OS PARE 1 JHP1 IN SD CARD Ce Ed SPARE I2 7 sPaRE RE Da Du kg L2 SACIN SENSOR PRESSURE 140d NOISWHd ks Id LI all LA Ts az e J BEEPER IB VAC REGI 35 vac REEZ L SD SPARE ACI VALVE PACE 1 4n un a Is E m I r1 DN Dr m el c E Gi 7 I FIRE RATING HI SC a eee Line Voltage OUTITAASS 210423 ASMOd 339000673510 nr verd GE VALVES MATVEJ VRLVE e e Figure 25 Ultra Fluid Cart Mother Board Schematic dMWnid JHA TdMnd JHA m M Ultra Cart Technical Manual 27 2 8 2013 GD 99021 Rev E Preventative Maintenance The cart preventative maintenance schedule is presented below Preventive maintenance parts kits can be otdered directly from DMS by calling 1 888 466 6633 Ultra Fluid Cart Preventative Maintenance Schedule Table 2 Preventative Maintenance Schedule Year End Required Parts Annual PM Kit UL HF100 1 Vacuum Hose If equipped MI TP RT516 15ft 4 5m N
16. BLE CONVERSION SUPPLIES ON A PURCHASE AGREEMENT OR TRIAL AGREEMENT ENTERED INTO IN CONNECTION HEREWITH 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 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 or to any other person or entity for incidental or consequential damages DMS teserves 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 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 teserves the right 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 wa
17. DMS service personnel at 1 888 466 6633 to report this issue don t continue to use the equipment Environmental Protection Infectious Waste None Waste Disposal Accessories There are no current accessories required for disposal from this unit Ultra Cart Technical Manual 7 2 8 2013 GD 99021 Rev E Reusable Suction Reservoir Use and Processing e Reservoir Use Cart reservoirs consisting of a reusable fluid collector and single use lid shall be used in place of traditional disposable suction canisters liners in surgery Cart reservoirs are considered non critical and non sterile medical devices and should be handled accordingly The fluid collection ranges for each reservoir is 0 to 13 000mL for an Ultra Quad and 0 to 16 500mL for an Ultra Duo The accuracy of the digital readouts on the Ultra Duo and Ultra Quad is 150mL The graduations on the exterior of the reservoirs are approximations only Record fluid volume as needed from the digital readouts on the touch screen display CAUTION Reservoirs are not meant to be used in tandem as this could damage the equipment Fluid must not be pumped directly into the reservoirs as this could cause the single use lid to become dislodged or damage the equipment CAUTION DO NOT use solidifier in the cart reservoirs It will make the cart inoperable until it can be setviced to clean out the reservoir and may cause damage to the equipment e Reservoir Processing WARNING Follow
18. Dornoch Medical Systems Inc Transposal Ultra Cart Technical Manual Model No UL QD2800 Model No UL DU500 w IV Pole optional ER Ultra Cart Technical Manual 2 8 2013 GD 99021 Rev E Ultra Cart Technical Manual 2 8 2013 GD 99021 Rev E Contents INTO ere lee 1 Iriporteri Inrorfrigtlopieseeesasteeeesaesespestesunn E E un pne 2 Intended Tee 2 Equipment Descrip oa ss ae eee 2 User Patent safely esee eene EEUU O ee 3 EE a a 4 Species ee nn re 4 DEE D Safety Redtures ee 7 Environmental e dE 7 Waste Disposal EE 7 Reusable Suction Reservoir Use and Processing SE eere 8 Instructors TOUS e eee eee 9 Models IDUZS00 SCODZDUU 5esesiueseieeneeeeueeg A seen green 9 SI CONGCHO MM C ELE 9 Models DUSUD CODO ER RER en RER duod enn eee erat 10 FUE Ge cee n Ea a a 10 Preparing for the Next ele ER 1 Control Knob Regulated Mogel deed 11 Fluid ColleCtlOri eege eege EE EE EECHER EE EE EE EECHER Err daran 11 Al Eleng t E Eeer Eege geen 12 Transporting CAE D DD DL MM MM ME MI MIDI MM M DM OD MCI C CO 12 ugh tow Mode Optional Feature seccoar eee nennen eene E 12 G n ral Usage Information ee 13 Male Use lads Maniiolds and Disposable SUCTION TUDING Serre A e 13 Early Warning and Overflow Protection System dedisse li teile ARMES NAN HEAR ANTENNES 14 Al Ma le Vacuum coin LL LLL I E LE 14 apio Var and EES 14 TP DE2800 Application Intobtiratioriand PRECAUTIONS Regel 15 Buggi Let lala 15 Periode EIERE EE 15 TEE
19. Health Association OSHA requires that all workers having exposure to potentially infectious materials should wear the correct personal protection equipment Ultra Cart Technical Manual GD 99021 Rev E 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 ALWAYS follow reservoir overfill alarms to prevent overfill 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 ALWAYS have more than one person unpack and lift the equipment off the shipping pallet Perform 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 covets on this equipment User operation does not require access to these areas The unit is for use within the hospital and or surgery center The unit is moveable but is not intended to be transportable or used in the outside environment To be used within the healthcare facility ONLY DO NOT use the system with patients that are being treated with radioisotopes or hazardous chemotherapy
20. ITED 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 Cart Technical Manual 31 2 8 2013 GD 99021 Rev E
21. Remove the manifold from the housing and tip it forward so the ports face slightly down Take the cap off of the back of the housing and place it on the bottom of the manifold Figure 14 Step 2 Cap the Vacuum Only port and dispose of the manifold pet facility red bag waste policy Step 3 Reset the reservoir fluid volume to zero by pressing the digital value below the reservoir icon and following the instructions Number of resets limited to four total resets between cart cleanings Step 4 Insert a new manifold and proceed to Step 3 in the Fluid Collection section on the previous page Control Knob Regulated Models Fluid Collection Note Follow the first 3 steps in the Models Using Single Use TP DL2800 Lids section to get the cart set up for fluid collection Then proceed as follows Step 4 Turn reservoir vacuum ON or OFF by pressing the desired reservoir icon on the cart s touch screen Step 5 Verify suction at a port Attach patient tubing to port s on the green lid Figure 15 Warning DO NOT apply High Flow suction or allow A extended exposure of suction to the tissue associated with procedures that require either no suction low vacuum ot low flow suction Failure to comply may result in severe injury or death Step 6 Regulate suction by turning the Increase Suction knob clockwise to decrease counterclockwise to increase Figure 16 Warning Manual regulation of the
22. acity options are available The Ultra Quad 4 reservoirs collects up to 52 liters of fluid while the Ultra Duo 2 reservoirs collects up to 33 liters Once fluids are collected the cart is connected to an Ultra Evacuation Unit evac to process the reservoirs 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 cart 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 requirements for the unit This is the Technical Service Manual and it is broken into eight sections including e Introduction e Technical Description o Operation e Instructions for Use e Installation e Maintenance o Company Information o Limited Warranty As a supplement to these two manuals instructional video s are available to assist maintenance personnel in their understanding 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 Cart Technical Manual 1 2 8 2013
23. amage DO NOT use any component if damage is apparent ALWAYS close all unused ports and remove all unused tubing to maintain optimal suction levels The suction levels of each canister are interdependent and linked to a common vacuum source Failure to comply may result in the unexpected reduction of suction and patient injury The suction level of this product relative to its vacuum limit setting may fluctuate significantly but will not exceed its limit DO NOT use this system if vacuum fluctuation may cause patient injury ALWAYS consider the type of surgical procedure before using this system ALWAYS follow current local regulations governing procedure specific suction levels to remove fluid waste safely from a surgical site Reservoirs are for surgical and bodily fluid collection only do not place any items into the reservoir for disposal Caustic or other harmful chemicals may harm the equipment and will void the warranty Handling biohazard waste is potentially dangerous ALWAYS follow current local regulations governing biohazard waste to safely handle and dispose of surgical fluid waste Manifolds and suction tubing may contain surgical waste after use ALWAYS handle these disposable accessories as potentially infectious materials after use ALWAYS wear gloves and protective eye wear when removing and disposing of these disposable accessories The Blood borne Pathogens Standards provided by the Occupational Safety and
24. chnical Manual 14 2 8 2013 GD 99021 Rev E TP DL2800 Application Information and Precautions To place a TP DL2800 lid onto a reservoir press it onto the lid ring with two hands working around the outside edge toward the back of the cart Another option is to cap all of the ports and use suction to pull the lid onto the lid ring When positioning the TP DL2800 single use lid onto the cart check that port caps are not caught under the lid Figure 18 Cap all ports prior to transporting the cart Figure 18 Port Cap Under E CAUTION Do NOT insert objects into the reservoir Figure 19 Reservoir contents are to be collected with suction only Depositing gloves trash or other miscellaneous items will CLOG the reservoir making it unable to drain and rendering it inoperable Figure 19 DO NOT Insert Objects Unit Information and Error Messages The cart provides the operator feedback for common operating errors via the display panel The most common messages ate described below Please call DMS at 1 888 466 6633 for assistance with any error message Warning or Error Action Required Tandem Error This message indicates fluid has Verify fluid lines are only hooked to reservoirs that been detected entering a reservoir that does not have are turned on Do not tandem reservoirs or pump vacuum applied directly into reservoirs Call service if necessary Temperature Errors This message provides notice Finish the curre
25. ctromagnetic Compatibility Requirements and Rope 10 A Tine Delayed Fase ids ano E emacs with a Hospital Grade power ISO 10079 1 Electrically Powered Suction Equipment P j cord only and must be IEC 60529 rating certification of IP41 connected to a Hospital Grade power receptacle only This equipment complies with and is Listed under the IEC 60601 1 2 4 Edition Standard for a Class 1 Medical Device Model Number Serial Number Patent Pending Suction Rating Label This label is used to inform the user of the maximum level of vacuum that can be developed by the Maximum Level 700mmHG system This label is located on the collar of the monitor pole Suction High Vacuum High Flow Receiver Warning Label This label is used to warn the user Warning Do Not Touch of the electrical pins and connectors inside the receiver of the mena Pine set omm catt This label is located under the receiver doors Do not connect any item here except evac coupler Receiver Warning Label French version Ne touchez ni les connecteurs ni les broches internes Hospital Suction Information Label This label is used to inform the users of the hospital suction supply requirements Vacuum Draw 85 lpm 300 mmHg This label is located under the wall vacuum connector Connect to Hospital Suction Only Ultra Cart Technical Manual 17 2 8 2013 GD 99021 Rev E Air Filter Filter to be Changed Once per Year See the Preventa
26. e specifications are as follows e Fuse Replacement for the main ICB power LT5A250VP time delayed fuse e Fuse Replacement for the vacuum pump MDL8A250V time delayed fuse e Spare fuses are provided in the upper left hand corner of the board for the above listed fuses The Power Entry Module contains two each LT10AL250V fuses Power Cord Replacement Contact DMS for replacement only Cord is rated for hospital use with the electrical requirements of the cart Ultra Cart Technical Manual 22 2 8 2013 GD 99021 Rev E Fluid Paths and Wiring Diagrams Surgical Surgical ji SAME Line Filter Line Filter WEE Filter Filter Vacuum High Flow High Flow Vacuum Regulator Vacuum Vacuum Regulator 1 Valve 1 Valve 2 2 Vacuum Ne Valve 1 Valve 2 Vacuum Manifold Vacuum Relief Valve Exhaust Wall Vacuum Muffler Vacuum Vacuum Atmosphere i Valve 3 Valve 4 Atmosphere Vacuum High Flow High Flow Vacuum Regulator Vacuum Vacuum Regulator 3 Valve 3 Valve 4 4 Hydrophobic Filter Hydrophobic Line Filter Line Filter Filter Reservoir 3 Field Field Reservoir 4 Surgical Surgical C wann QD2800 amp
27. ement 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 Transposal 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 1s 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 I ITEMS AND PRODUCIS 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 III ITEMS AND PRODUCTS IDENTIFIED AS CONSUMA
28. ent to prevent backflow The hydrophobic filter in the bottom on the single use lid or single use cart manifold is a secondary means mechanical of safety to prevent liquid from getting into the vacuum line Optional overflow alarm sequence will do the following Cart will alert the user when the reservoir is 2500mL from full capacity Cart will alert the user when the reservoir is 1000mL from full capacity Cart will shut vacuum off and alarm when full user must acknowledge alarm Alternate Vacuum Source Equipment Malfunction or Power Loss Situation An alternate source of vacuum should be readily available in the event the cart can no longer provide suction to the reservoir The cart can still be used with an external vacuum source hooked directly to the Vacuum Port of the single use lid Vacuum regulation and volume readout will not be available with the cart setup in this configuration Rapid Full Vacuum and Specimen Collection Application that Requires Full Suction in Ten Seconds or Less On the back of the unit there is a place for a canister ring holder Place a canister ring TP RH100 into the holder and then either an 1800cc TP RC1800 reusable TP DCL1800 disposable w lid or 2800cc TP RC2800 reusable TP DCL2800 disposable w lid canister into the ring Hook the black vacuum adapter from one of the reservoirs to the vacuum port on the canister lid and turn on the vacuum for that reservoir Ultra Cart Te
29. equipment NOTE Liquid will remain in the reservoir after processing is complete This liquid contains a small amount of enzyme for starting the breakdown of fluid waste collected during the next case High Flow Mode Optional Feature High Flow Mode is an optional feature available on some carts It allows a boost in suction to a customer selected reservoir when more suction is needed Suction boost is still limited to number of lines hooked to the reservoir and if another reservoir is in use If increased suction is required during the procedure adjust the regulated vacuum to full and then press the UP arrow one additional time to activate high flow mode Figure 17 To deactivate high flow mode press the down arrow to return to regulated suction Ultra Cart Technical Manual 12 2 8 2013 GD 99021 Rev E General Usage Information Single Use Lids Manifolds and Disposable Suction Tubing Single Use Lid TP DI 2800 The single use lid has three suction ports Any one of these ports and up to three can be used to collect fluids The suction ports are labeled 1 Patient this port is used for routine collection of fluids 2 Tandem this port is used for routine collection of fluids CAUTION The use of this port to tandem reservoirs together is not allowed on carts as this can cause damage to the equipment 3 Ortho this port is used for routine collection of fluids or used when larger suctioned particulate may
30. linders of the Ultra Fluid Cart 2 8 2013 9 Optional Y H l IV Pole Touch Control Panel pu Bl Single Use Tid Evac Coupler Receiver 55 Wall 140 Vacuum Outlet Power Cord Receptacle Reservoirs 24 61 24 61 Figure 1 Ultra Duo Cart Dimensions and Features Dim inch cm Panel Optional Touch Wr c IV Pole Control Single Use Evac Lids Coupler Receiver 55 Wall 140 Vacuum Outlet 4 l Power Cord Receptacle Fluid Reservoirs 25 58 33 84 Figure 2 Ultra Quad Cart Dimensions and Features Dim inch cm Ultra Cart Technical Manual 5 2 8 2013 GD 99021 Rev E 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 liter reservoirs and Ultra Quad Fluid Carts have four 13 0 liter resetvoirs Reservoirs can be used with wall vacuum and or the on boatd vacuum pump A single use lid Figure 3 or manifold Figure 4
31. nit and other devices located and or operated within the area of the operating room suites 2 8 2013 Technical Description Specifications Item Certifications FDA Product Code FDA Manufacturer Patents Installation Size inch cm Weight lbs ei Utilities Power Additional Cooling Flammable Rating Operation Method Mode Performance Fluid Capacity IV Pole Cleaning Table 1 Equipment Specifications Ultra Quad UL QD2800 UL QD500 ETL Listing Class 1 Medical Device Complies with the following IEC 60601 1 General requirements for safety of medical equipment devices IEC 60601 1 1 Collateral Standards for Medical Equipment IEC 60601 1 2 EMC amp RFI compliance testing standard IEC 60529 Degrees of protection provided by enclosures m FDA 510K Certification K081047 ISO 10079 1 Medical Suction Equipment electrically powered suction equipment FDA standard for hospital suction systems CAN CSA Standard C22 2 No 601 1 JCX carts FNY lids JCX carts FNY lids 115 120VAC 60Hz 4 5 amp Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or with nitrous oxide Connected to the facilities main vacuum system or as a standalone device Continuous High Vacuum High Flow maximum vacuum level obtainable is 0 700mmHg Measured with all ports closed If connected to hospitable suction obtainable
32. nt surgical procedure and then that the temperature monitoring system in the unit remove the cart from use Contact service once has detected an elevated temperature the cart is available for repair Processing Required This message notifies the user Finish the current surgical procedure and then that the cart has not been processed for 16 hours process the cart with the evac since it was used to collect fluid Periodic Maintenance Interval Activity Prior to each use Inspect the collection reservoirs for cracks and the two casters for failed lock and steer and after each levers Ensure there are no cuts in the power cord and no bent pins in the power cord cleaning receptacle DO NOT use if the equipment if damage is present Check the level of the enzyme and bleach in the bottles Replace the bottles as required Ultra Cart Technical Manual 15 2 8 2013 GD 99021 Rev E Troubleshooting Guide Problem Unit Will Not Operate Possible Solutions 1 Check that the machine is plugged into an operational outlet 2 Check that the switch on the rear of the unit 1s turned on and that the power cord 1s all the way into the receptacle 3 Call maintenance to replace the internal fuses Problem Display is Powered Cannot Get Vacuum Pump to Turn On Possible Solutions 1 Go to the setup screen and verify wall suction only button is not green 2 Try to run the unit with wall vacuum 3 Call DMS at 1 888 466 6633 Problem
33. orities with jurisdiction to impose additional requirements for qualifications on setvice 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 cart unplug the unit from the wall outlet Not unplugging this unit will leave dangerous voltages amp current accessible to the service personnel working on of in this machine NOTE If the unit is to be moved wipe 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 service Additional Information Upon request DMS will provide the following Circuit Diagrams Component Parts List Description of Components
34. ote Preventative Maintenance Procedures are available upon request by contacting Customer Service at 1 888 466 6633 Ultra Cart Technical Manual 28 2 8 2013 GD 99021 Rev E 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 manufactured 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 Cart Technical Manual 29 2 8 2013 GD 99021 Rev E 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 Agre
35. pressure with the A adjustment knob affects all in use reservoirs Failure to comply may result in the unexpected reduction of suction and patient injury Ultra Cart Technical Manual 11 GD 99021 Rev E Figure 14 Used Manifold Removal Figure 15 Patient Tubing and Lid Figure 16 Vacuum Pressure Control Knob 2 8 2013 All Models Transporting the Cart After the surgical procedure is complete the cart needs to be transported to the evac to be emptied cleaned and rinsed Warnings Always remove the disposable accessories and lower the IV pole prior to relocating the cart Always use the handle to retain control of the cart during relocation Step 1 Turn off the suction in the cart by pressing all activated reservoirs on the carts touch screen Step 2 Remove patient tubing and cart vacuum lines from the green single use lid s and seal all ports with the attached caps Step 3 Detach wall vacuum line and power cord from the wall and wind onto the cart s storage bracket Unlock the caster to allow the catt to be transported and move it to the evac for processing Step 4 Once the cart is processed and used single use lids are discarded wipe down the cart with a hospital approved bleach wipe Sani Cloth Bleach Germicidal Wipe DMS UL BW100 Clorox Germicidal Wipes ot equivalent and place clean single use lids onto the cart CAUTION Non approved wipes may cause surface damage to the
36. ra Cart Technical Manual 2 2 8 2013 GD 99021 Rev E User Patient Safety A WARNINGS DO NOT apply High Flow suction or allow extended exposure of suction to the tissue associated with procedures that require either no suction low vacuum or low flow suction for example passive chest drainage ALWAYS consider the type of tissue associated with the surgical procedure BEFORE using this system Failure to comply may result in severe injury or death Before using this system read and understand the information in this manual Suction equipment should only be used by people that have had adequate training on the use of this type of equipment Pay special attention to WARNING information Become familiar with the system components prior to use The health care professional performing any procedute is responsible for determining the appropriateness of this equipment and the specific technique used for each patient Dornoch Medical Systems Inc as a manufacturer does not recommend surgical procedure or technique DO NOT use this system outside the scope of the defined indications for use DO NOT use this system for applications that require a constant vacuum level The reservoir scale and fluid volume display are not diagnostic tools DO NOT use the scale or volume display to accurately calculate the amount of fluid loss from the patient Upon initial receipt and before each use operate the equipment and inspect each component for d
37. red reservoir icon under the Light buttons on the cart s touch screen Figure 9 Step 5 Verify suction at the port on the green lid Step 6 Load any required IV fluid onto the optional IV pole Do not load more than 6000mL of IV fluid on the provided IV pole Step 7 Attach patient tubing to port s on the green lid A Warnings DO NOT apply High Flow suction or allow extended exposure of suction to the tissue associated with procedures that require either no suction low vacuum ot low flow suction Failure to comply may result in severe injury or death Step 8 Regulate suction using the arrows on the vacuum scales next to the appropriate reservoir image Figure 8 and Figure 9 High Flow Mode Optional Feature If increased suction is required during the procedure adjust the regulated vacuum to full and then press the UP arrow one additional time to activate high flow mode Figure 17 To deactivate high flow mode press the down arrow to return to regulated suction Ultra Cart Technical Manual 9 GD 99021 Rev E Use 3 3 ar I in 00 TO O4 TWCTD 8 TO OA TACT GH zn y El UP Figure 8 DU2800 Display CYL 1 CYL 2 es grec 3375 12120 10530 CYLINDER 1 458 mmHg TOA OA IOCU TOW O4 I0OCU UP ALL VOLUMES IN mL Figure 9 QD2800 Display Sono 212 ALL VOLUMES IN mL Figure 7 Vacuum Adapter and Lid O C No T ib CYL
38. rranty applies to the original purchaser only and 1s 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 Ultra Cart Technical Manual 30 2 8 2013 GD 99021 Rev E PURCHASER 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 D ANY 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 IT ANY TRANSPOSAL PRODUCT A IS 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 LIM
39. s QUE RE RE EXE P at ES RIEN race Rok Fa te en Rd EO ERR 9 Figure o DU2SDD e 9 Roure 9 0D29800 DISPO eme ERE RO OE REN ena ee D ae 9 Figure 10 CL500 Manifold ASS E 10 Figure 11 Vacuum Adapter Manifold and COVER scisco ek go RE RP Fox E FE TX KY Fes Xx Ree EY ten tiers 10 Figure 17 e ENN ET 10 Hore 13 OBS NP a 10 Figure 14 Used Manifold Removal eene nennen NK RN NK nnne nnn nnne nnn nnn nnn nnn nne 11 Fig ure 15 Patient Tubing and Lis ete ad rao ed aaa ee S o RC e ci e E eb ca Rad Ec d i cti 11 Fl CI eddie iz eU tun POSE RES O TO TTE 11 Figure 17 Mon FIOW Mode IndicdlO EE 12 Figure 19 Port Cap Under A aE A AAAA DUM SEU 15 Figure 19 DOJNOT Insert ODESSA 15 Figure 20 Environmental Conditions sciens de nix nette feminin end CU LEV RS 20 Figure 2 Bi CN Fluid Cart Yacht Flow Re Tel aid 23 Figure 22 Ultra Fluid Cart Fluid Flow DIS FAN Re Aa 24 Figure 23 Ultra Duo Cart Electrical Wiring Diada Misa 25 Figure 24 Ultra Quad Cart Electrical Wiring Diagram eee 26 Figure 25 Ultra Fluid Cart Mother Board EE ge eege dE enee 27 Ultra Cart Technical Manual 2 8 2013 GD 99021 Rev E Introduction The Transposal Ultra Fluid Cart cart 1s designed to collect surgical fluids from one patient at a time in a reusable suction device that can then be emptied cleaned and rinsed The cart is also designed to enhance or replace main wall vacuum supplies in operating room suites Two fluid collection cap
40. servoir design allows separate suction level measurement Howevet the carts contain a single vacuum pump A suction level decrease in any reservoir due to an open port or line may cause the other reservoir to decrease Once the system is installed operators use the carts to collect fluid during surgical cases and then move them to the evac where they are processed Once the evac cycle is started the reservoirs are automatically emptied cleaned and rinsed The carts are then wiped down and with the addition of a new single use lid or manifold are ready for another surgical procedure Carts come in two model options with the main difference being the single use disposable The two models are the Ultra Fluid Cart UL DU2800 Duo with Canister Lid and UL QD2800 Quad with Canister Lid and the UltrafleX Fluid Cart UL DU500 Duo with Cart Manifold and UL QD500 Quad with Cart Manifold The 2800 configuration is designed for single patient use in each reservoir as well as high fluid generating procedures The standard configuration Ultra Fluid Carts use the Transposal Single Use Lid TP DL2800 to provide the suction to the surgical field The other configuration option is the Ultraf zX Fluid Cart designed for the busy Operating Room demanding multi patient fluid collection and high vacuum flow The special Ultraf X Fluid Cart Single Use Manifold UL CL500 supports these needs with a convenient easy to use remove and seal design Ult
41. t Instructions Please contact DMS at 1 888 466 6633 prior to de installation or re installation of carts If a Customer de installs or re installs a cart the guidelines listed below must be followed e Always weat personal protective equipment including eye protection and latex gloves to prevent contact with potentially infectious material e Always unplug the unit from the wall outlet before moving equipment e Wipe down the unit with an approved contact disinfectant after each use Ultra Cart Technical Manual 19 2 8 2013 GD 99021 Rev E 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 all of the fluid from the reservoirs Operation Storage and Transportation 40 C 40 C Temperature 20 7595 75 Relative Humidity 1060 hPa 1060 hPa Atmospheric r p ib Pressure 700 500 Figure 20 Environmental Conditions Ultra Cart Technical Manual 20 2 8 2013 GD 99021 Rev E Maintenance Qualifications 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 6622 Qualifications needed to propetly service products manufactured by DMS in no way allows for or authorizes any person to avoid the auth
42. 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 ot 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 disinfectant wipe Sani Cloth Bleach Germicidal Wipe 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 e 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 e 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 e 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 1s in place on the lid or manifold If it is the first case of the day or the cart has just been processed
43. tion Failure to comply may i 3 T ip s iU Co TO O4 I0OCU TO O4 I OCU O C N E E nr al OB Xj result in severe injury or death 3375 1212 ure 12 DU500 Display ie Step 8 Regulate suction by pressing the up or down arrow on the Fi vacuum scale next to the appropriate reservoir image Figure 12 and Figure 13 Oo h D MO N UL k 4 Mx F n S NIN o lt I5 M 10530 CYLINDER 2 602 mmHg CYLINDER 1 High Flow Mode Optional Feature 458 If increased suction is required during the procedure adjust the regulated vacuum to full and then press the UP arrow one additional time to activate high flow mode Figure 17 To deactivate high flow mode press the down arrow to return to regulated suction K E 3 JE ip TOM O4 TACT P LI E H I o s T a P A v CO CO zl Cn NO N C SET UP ALL VOLUMES IN mL Figure 13 QD500 Display Ultra Cart Technical Manual 10 2 8 2013 GD 99021 Rev E Preparing for the Next Procedure To use the same reservoir for the next patient use the following steps Otherwise use an empty reservoir or transport the cart to the evac for processing Warning Follow the current local regulations governing A biohazard waste to safely handle and dispose of surgical fluid waste Step 1 Cap all of the patient ports but leave the Vacuum Only port uncapped
44. tive Maintenance Section in the Technical Manual HEPA Filter Filter to be Changed Once per Year See the Preventative Maintenance Section in the Technical BRAKE Consumables and Accessories component Of accessory Air Filter Label This label is used to inform the users of the air filter replacement requirement This label is located on the air filter housing HEPA Filter Label This label is used to inform the users of the HEPA filter replacement requirement This label is located on the air filter housing BRAKE Label This label is used to inform the users of the Brake Caster and is located on the lower cabinet side panel above the brake caster STEER Label This label is used to inform the users of the Steer Caster and is located on the lower cabinet side panel above the steer caster WARNING Use only Dornoch approved components and enzyme DO NOT modify any The following is a list of consumables and accessories associated with the cart e TP DL2800 Single Use Canister Lid e UL CL500 Single Use Cart Manifold e UL IV100 IV Pole Assembly Mounts to the back panel of the unit and can hold up to 6000mL of fluid e UL SF100 Ultra Smoke Filter Placed between the vacuum port on the lid and the vacuum hose to protect the cart vacuum supply e UL ST100 Ultra Specimen Trap Specimen collection device designed for the cart Placed on the port on the lid and
45. uipment 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 eround from the main power cord and another located on the ground for the 24VDC power supply Functional Earth Ground Symbol This label is used to symbolize a functional earth ground They are located near all functional grounds Single Use Symbol This label is used to symbolize that the product is single use only This label is located on either of the single use lids Consult Instructions Symbol When displayed on a device it refers the user to accompanying instructions and identifies safety and precautionary information Electrical Requirements Serial Number and Operating Instructions Label See Below Located on the back of the unit under the electrical cabinet access panel This label is used to instruct the user to the manuals Information contained on this label DMS contact information serial number ETL compliance information electrical information patent information and power outlet requirements Dornoch Medical Systems Inc 200 NW Parkway Riverside MO 64150 www dornoch com 888 466 6633 This equipment complies with and is approved for use under 115 T 120 VAC 60 Hz TEC 60601 1 General Requirements for Safety Nominal 0 2 4 5 A IEC 60601 1 1 Satety Requirements for Medical Electrical Systems ens a UU gt gn eplace fuses wit Ele
46. urgical fluid waste e Interactive Controls The 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 evac e Vacuum Protection Hydrophobic filters on each green single use lid or manifold prevent main line vacuum contamination In addition DMS s unique vacuum adapter only connects to lid or manifold protected vacuum ports e Air Exhaust Protection Air exhausted through the on board suction pump is filtered using a replaceable HEPA rated filter e Early Warning and Overflow Protection System Will alert the user when the reservoir is 1000mL from full capacity and will do the following to avoid an overfill situation 1 Reservoir will no longer be used and the vacuum will automatically shut off 2 Reservoir is then automatically vented to prevent backflow 3 Once the reservoir is shut off due to the Early Warning System it must be processed with the evac in order for it to be reset for further fluid collection use 4 The hydrophobic filter in the bottom on the single use lid or single use cart manifold is a secondary means mechanical of safety to prevent liquid from getting into the vacuum line Note If fluids or solids are drawn into the vacuum pump during operation immediately discontinue use and remove the equipment from service Contact
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