DMDM 10545100-CE_English
Contents
1. There are four alarm conditions on the DIGITAL MDM mixer They appear in the safety alarm display see Figure 1 item 2 only when conditions warrant Otherwise they are not visible The alarm conditions are OXYGEN FAILURE This alarm indicates that the set oxygen O2 flow cannot be delivered Check the oxygen supply During an OXYGEN FAILURE alarm the nitrous oxide delivery is automatically shut off The LPM FLOW and OXYGEN displays are off NITROUS FAILURE This alarm indicates that the set nitrous oxide N20 flow cannot be delivered Check the nitrous oxide supply During a NITROUS FAILURE alarm the LPM FLOW display indicates oxygen flow and the OXYGEN display is off Both the OXYGEN FAILURE and NITROUS FAILURE are self canceling alarms When the gas is restored the unit returns to the flow rate and mixture ratio which were in effect before the alarm condition 1 LPM OXYGEN LIMIT This message is displayed when the oxygen flow rate reaches a value of 1 LPM liter per minute the unit will not allow the oxygen flow rate to go below this value lf the user attempts to lower the OXYGEN while this message is displayed the unit compensates by increasing the total flow rate FLUSH FLOW LOW This message indicates that the oxygen flush flow rate is less than 10 LPM Check the oxygen supply pressure CAUTION Operate key pad with finger pressure only Do not use hard or sharp objects Failure to do so may result in2. iad Parker Hannifin Corporation J Porter Instrument Division i 245 Township Line Road rx Hatfield PA 19440 f Parker Office 215 723 4000 Fax 215 723 5106 Digital MDM Operations Manual by AA173200i This product complies with the Medical Device Directive 93 42 EEC 0473 A Declaration of Conformity in accordance with the directive has been made and is on file EC REP European Communities should contact the Authorized Representative listed below regarding any Medical Device Directive MDD inquiries Contact Name Parker Hannifin Ltd Instrumentation Products Division Mailing Address Riverside Road Pottington Business Park Barnstaple EX 31 1NP England Phone 44 0 1271 313131 Fax 44 0 1271 373636 The Quality System for Porter Instrument is certified to ISO 13485 The scope of our registration is The design manufacture distribution and servicing of Nitrous Oxide Oxygen Sedation Flowmeters Gas Scavenging Systems Gas Distribution Systems and Office Communication Systems for use by a physician dentist or licensed healthcare Profession Check our website www porterinstrument com for additional information To register your product www porterinstrument com resources dental choose Warranty tab To download a User s Manual www porterinstrument com resources dental choose Manuals tab 10545100 CE English IMPORTANT READ MANUAL COMPLETELY Before Operating This Devic
3. DAMAGE to front panel Key Pad Controls On Off Key The ON OFF key controls the operation of the unit Momentarily depressing the ON OFF key changes power state from OFF to ON or ON to OFF Note If the power to the unit is interrupted and then restored either by disconnecting reconnecting the power cord or by local power failure the unit will display OFF The operator must press the ON OFF key to restart the unit The unit will them display default values of 100 oxygen at 5 LPM CAUTION After turning the device off or when the unit is not in use all oxygen and nitrous oxide supply cylinder valves must be closed Flow Control The LPM FLOW key pad A or V controls the total flow rate delivered by the unit Pressing the appropriate key momentarily increases or decreases the total flow rate by 0 1 LPM By pressing and holding a key the total flow rate indication changes slowly for the first two steps then changes at a faster rate for the remainder of the time the key is held An audible signal indicates that a limit has been reached 0 Control The OXYGEN key pad A or V controls the percentage of oxygen delivered by the unit Press the appropriate key momentarily to increase or decrease the oxygen percentage one step 1 or 5 Pressing and holding the key changes the oxygen percentage slowly for the first two steps then faster for the remainder of the time the key is held This varies the ratio of oxygen to nitrous
4. flow rate and mixture ratio which were in effect prior to the flush Alarm Test Silence Key The alarm test silence key serves two functions When pressed all the display indicators and the audible alarm turns ON This key also silences the audible alarm when a NITROUS FAILURE condition exists The audible alarm will be silent for about five minutes and then resume unless the failure condition has been corrected Machine Diagnostics The DIGITAL MDM mixer performs self checks at start up and during operation If any errors are detected the unit displays EE on the OXYGEN display and an error code on the LPM FLOW display If an error code appears remove the unit from patient service and call the Matrx by Parker Technical Service Department at 1 888 723 4001 To aid in the diagnostics of the unit make note of the final error code displayed General Installation Refer to FM 916 Mobile E Tank Stand Installation and Instructions for connecting gas supply to the flowmeter and tank installation to mobile stand If the optional Scavenger Control Valve was purchased separately align it with the 2 holes on the base of the mixer Secure with the 2 10 32 screws Following the instructions provided with the scavenging system connect the Scavenger Control Valve to the vacuum system Installation of Rubber Goods The assembly procedure for the DIGITAL MDM mixer follows see Figure 2 1 Slide the breathing bag openi
5. of gas pressure Indicated Flow Delivery Test Set the OXYGEN display to 100 Press the V flow key and hold as shown in Figure 1 The flow rate should decrease to 1 0 LPM An audible alarm sounds at the lower limit while the key is held Press the AJ flow key and hold The flow rate should increase to 9 9 LPM An audible alarm will sound at the upper limit as long as the key is held Indicated Percentage Delivery Test Set the LPM FLOW display to 9 9 LPM Press and hold the W OXYGEN key The OXYGEN display should decrease to 30 The audible alarm sounds at the lower limit while the key is held Press and hold the A OXYGEN key as shown in Figure 1 The OXYGEN display should increase to 100 An audible alarm sounds at the upper limit while the key is held Basic Delivery Technique Practice titration Titration is a method of administering a substance by adding definitive amounts of a drug until an endpoint is reached For nitrous oxide oxygen N20 Os sedation N20 is given in incremental doses until a patient has reached a comfortable relaxed state of sedation The ability to titrate N2O is a significant advantage because it limits the amount of drug to that which is required by the patient If titration is done properly the patient does not receive any more of the drug than is necessary The amount of N2O required by a patient on any given day or time varies For information on titration a
6. use of Nitrous Oxide Oxygen Conscious Sedation for patient analgesia and be properly trained in its administration prior to using this product For training requirements on the administration of Nitrous Oxide Oxygen Conscious Sedation contact the appropriate regulatory authority in your country state or province Training is recommended to provide a practical hands on capability and an understanding of the behavioral aspects of Nitrous Oxide Sedation and will complement the safety features of this device The devices permit the operator to adjust the percent of oxygen through a range of 100 to 30 and thereby control the ratio of oxygen to nitrous oxide The operator can also control the total volume of mixed gas up to 9 9 liters per minute Use Scavenging Monitor for N20 in the patient treatment area to insure that controls are effective in achieving low levels of PPM parts per million exposure Contact your Porter dealer for details on monitors and testing Gas Supply Connection After installation of the flowmeter connect the nitrous oxide and oxide supply lines to the Diameter Indexed Safety System DISS fittings located on the back of the flowmeter unit It is important that the regulators for both gases be set to give pressures in the range of 53 PSIG 2 PSIG Confirm the absence of leaks at pressure connections on the unit Bubbles will appear at leaking locations when a soap water solution is used This procedure is recommended
7. ctromagnetic interference EMI BAG TEE REQUIREMENTS A bag tee containing an air inlet valve is required for use with this unit The bag tee is factory mounted on the unit or provided separately for remote mounting Matrx by Parker Scavenging Nasal Inhalers provide the patient connection FACILITY PIPING The user MUST perform tests independent of the dealer or contractor to verify that all pipelines are connected correctly If you are unfamiliar with piping systems order Matrx manual 10311700 The user has the ultimate responsibility for properly connected pipelines essential to patient safety DIAMETER INDEXED SAFETY SYSTEM Gas connections in the DIGITAL MDM mixer are mechanically indexed using the Diameter Indexed Safety System DISS This feature helps to prevent the crossing of pipelines Under no circumstances should these connections be altered DISCONNECT POWER There are no user serviceable parts inside this unit A shock hazard exists if power is not disconnected prior to any internal servicing or maintenance Always disconnect the power source before inspection or repair ALARM TEST The user should test the alarm system for proper operation prior to each clinical use 3 INTENDED USE FLOWMETER FOR ANALGESIA DELIVERY SYSTEM This device is intended for patient use by an attending physician dentist or licensed professional properly trained in its use Porter Instrument recommends the user be thoroughly familiar with the
8. e Basic delivery technique is described Also this manual contains instructions on periodically required checks to be performed by the user These checks are necessary to insure the proper performance of this device and its safety features Retain this manual for future reference A WARNINGS AND PRECAUTIONS These warnings and precautions are to help you to understand how to safely operate the MXR Flowmeter A WARNING alerts you to a possible hazard to people A CAUTION alerts you to the possibility of equipment damage WARNING Do not use this device for the administration of general anesthesia or as a part of or in conjunction with a general anesthesia administration system WARNING Workers are exposed to NO during administration of NeO Os conscious sedation analgesia NIOSH has recommended that exposures should be minimized Contact NIOSH 1 800 35 NIOSH to receive NIOSH Publications on Control of Nitrous Oxide in Dental Operatories Exposure can be minimized by effective controls National Institute for Occupational Safety and Health NIOSH publications state that controls including System Maintenance Ventilation and Work Practices can effectively reduce NO concentrations in patient procedures Your flowmeter accessory Porter scavenger system is an important part of the system of controls WARNING Porter Instrument equipment utilizes the cross protection system The flexible hose and connectors that connect to the flo
9. each time a cylinder is changed Refer to FM 916 Mobile E Tank Stand Installation and Instructions for connecting gas supply to the flowmeter and tank installation to mobile stand User Responsibility This product should not be repaired other than in accordance with written instructions provided by Matrx by Parker The user of this product shall have the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration by anyone other than Matrx by Parker It is the user s responsibility to ensure that the correct gas at the correct pressure is supplied to the fittings at the rear of the unit Machine Diagnostics The DIGITAL MDM mixer performs self checks at start up and during operation If any errors are detected the unit displays EE on the 0 display and an error code on the FLOW display If an error code appears remove the unit from patient service and call the Matrx by Parker Technical Service Department at 1 888 723 4001 To aid in the diagnostics of the unit make note of the final error code displayed Description of Unit The DIGITAL MDM mixer is shown in Figure 1 The device permits the operator to adjust the percent of oxygen through a range of 100 to 30 and thereby control the ratio of oxygen to nitrous oxide The operator can also control the total volume of mixed gas up to 9 9 liters per minute Mixture Control The DIGITAL MDM mixer precisely mixes oxyge
10. hat all gas pipelines are connected correctly prior to using the system The ultimate responsibility of assuring that lines are not crossed rests with the user WARNING During any power outage remember to turn OFF the flowmeter and manually turn OFF the tank valves With centralized electrically powered gas systems if gas was flowing when the power went out and the flowmeter is left ON gas will be flowing when the power is restored CAUTION This device is for use by or on the order of a physician dentist or licensed healthcare professional CAUTION Always use clean dry medical grade gases Introduction of moisture or other contaminants into this device may result in defective operation CAUTION Do not attempt to repair alter or calibrate this device Unauthorized repair alteration or misuse of this device is likely to adversely affect the performance and will void the warranty CAUTION Never oil or grease any part of this system minimize fire or explosion potential Symbol Description MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS IN ACCORDANCE WITH UL 2601 1 AND CAN CSA C22 2 NO 601 1 Alternating Current Earth ground Attention consult the accompanying documents Type B Equipment A WARNINGS and PRECAUTIONS ELECTRICAL CONNECTIONS Do not use an electrical cord with nicks cuts or other damage Do not use the unit with an extension cord as it will be subject to ele
11. most valuable resource for the practitioner is the Handbook of Nitrous Oxide and Oxygen Sedation written by Clark and Brunswick and published by Mosby www mosby com This text is a concise and contemporary guide for nitrous oxide oxygen administration Maintenance The DIGITAL MDM mixer is a precision analgesia mixing unit As with any medical instrument it requires periodic inspection and maintenance The following routine maintenance procedures should be performed to ensure system integrity and trouble free service Inspect mixer hoses and connections daily for damage wear and leaks Perform functional tests prior to each use These tests are described in Performance Checks While cleaning the outside of the unit observe caution so that liquid does not get inside Matrx by Parker recommends using a damp wrung toward dry cloth moistened with a mild soap or a plastic safe cleaner Do not spray directly on the case A hard surface disinfectant may be applied in the same manner CAUTION DO NOT submerge the unit use a damp cloth A WARNING Before cleaning the unit disconnect the DIGITAL MDM mixer s power cord from the electrical power supply Fuse Replacement International 220 240V 1 To replace a blown fuse turn the unit OFF disconnect power to the unit by unplugging the power cord from the wall and then remove the power cord from the input connector on the rear of the unit 2 Open the fuse compar
12. n and nitrous oxide from local cylinders or pipeline gas systems and delivers the electronically controlled mixture to the bag tee outlet Built In Safety A series of alarms see Safety Alarm System page 5 alert the user to any problem condition within the DIGITAL MDM mixer unit or in the gas supply Displays and Indicators In the following the location numbers refer to Figure 1 Flow Display The LPM FLOW display 4 normally displays the total gas flow rate It also displays the individual nitrous oxide or oxygen flow rates when either the N2O or O flow display controls 6 are pressed The gas flow being displayed is indicated in the flow indicator 5 by Oo TOTAL or NO OXYGEN Display The OXYGEN display 3 indicates the oxygen concentration set point in the total flow Gas Flow Indicators Gas flow is indicated by bar graph LEDs 1 A green bar graph represents O while blue represents the N20 flow The number of lit bars gives a graphical indication of the flow level of a particular gas 2 Safety Alarm l Display Gas Flow 3 Display NITROUS FAILURE 1 LPM OXYGEN LIMIT FLUSH FLOW LOW O FLUSH O Flush Button Oxygen Controls Alarm Test Silence Button Oxygen Flow Control 4 Flow Display 5 Flow Indicator OXYGEN Flow Display Controls ON OFF Button AA171500i Figure 1 Matrx DIGITAL MDM Mixer Front Panel figure shows all LEDs illuminated Safety Alarm System
13. nfigurations Quick Connect fittings are designed for rapid no tool connections with corresponding male female fittings or outlet stations Refer to the individual manufacturer s instructions for specific connection procedure DISS to DISS hoses are designed primarily for portable systems The gas source male DISS fittings are located on the regulators on the cylinder mount block provided with the portable units Connect the DIGITAL MDM mixer to the cylinder mount block using the appropriate nitrous oxide hose and the oxygen hose Demand Valve Resuscitator An optional Demand Valve Resuscitator for emergency oxygen resuscitation is available from Matrx PN 91505085 and connects directly to the O outlet Figure 3 on the rear of the unit Figure 3 Connection to the back of unit N20 DISS O2 DISS Demand Valve DISS l AA173100i Preparation for Use CAUTION Before using the DIGITAL MDM mixer check the operation of the unit by performing the following tests Performance Checks These preliminary tests must be conducted to ensure that your analgesia mixer is performing correctly If the unit fails any one of the following performance checks the unit must be returned for service Machine Turn On Test Press the ON OFF key as shown in Figure 1 After the device goes through an initialization routine the OXYGEN and LPM FLOW displays should indicate 100 and 5 LPM Alarm Indicator Lamp Te
14. ng over the outside diameter of the bag mount 2 Slide the 15mm fresh gas connector from the scavenger into the breathing tube connector 3 If an accessory such as the Scavenger Control Valve is used connect it following the instructions supplied with it Bag Mount Breathing Tube Connector Vacuum Nipple with small orifice Fresh Gas Connector Breathing Bag Vacuum Tubing AA172800i Figure 2 Installation of Rubber Goods Installation of Power Cord Insert the power cord into the input connector on the rear of the unit see Figure 3 Connection of Oxygen Nitrous Oxide For safety reasons gas connections are color coded and mechanically indexed using the Diameter Indexed Safety System DISS to prevent accidental cross connection DISS female hexagon fittings are standard for both hoses 1 Connect the DISS female hexagon fitting of the nitrous oxide hose to the male DISS N2O INLET fitting on the back of the mixer head see Figure 3 Hand tighten and then finish tightening with a 7 8 inch open end wrench approximately 1 8 turn Do not over tighten 2 Connect the DISS female hexagon fitting of the oxygen hose to the male DISS Os INLET fitting on the rear of the unit see Figure 3 Hand tighten and then finish tightening with a 11 16 inch open end wrench approximately 1 8 turn Do not over tighten Hoses Hoses are manufactured for connection to the gas source in various co
15. oxide An audible signal indicates that a limit has been reached Setting OXYGEN Step Amount 1 or 5 The DIGITAL MDM mixer is shipped from the factory programmed to change 1 for each press of the OXYGEN key pad or V The amount can be changed from 1 to 5 by using the DISPLAY N O and DISPLAY O keys and the following procedure 1 Press and hold the DISPLAY N O key 2 While pressing the DISPLAY N O key press the DISPLAY Os key until the audible alarm sounds 3 Release both keys The audible signal indicates the change has occurred and is programmed in memory The unit will remain in the new mode until this sequence is repeated Unplugging or turning the unit off will not affect the programmed mode Flow Display Control The key pad DISPLAY O or DISPLAY N O select the gas flow rate displayed on the flow display Press and hold the DISPLAY N O key to display the nitrous oxide component of the total flow Press and hold the DISPLAY Os key to display the oxygen component of the total flow If neither key is held the LPM FLOW display indicates the total gas flow Oxygen Flush Key Pushing the O2 FLUSH key delivers 100 oxygen directly to the mixed gas outlet at the rear of the unit This outlet is connected to the patient through the breathing tube connector see Figure 2 While the key is pushed 100 oxygen is delivered continuously at an approximate flow rate of 20 LPM Releasing the key returns the unit to the
16. st Press the alarm test silence key as shown in Figure 1 and observe that all the alarm readouts illuminate The OXYGEN and LPM FLOW displays should show 8 8 8 and 8 8 respectively The alarm readouts should illuminate with the numerical displays 10 bars on each gas should illuminate The audible alarm should also sound Oxygen Failure Test Set the LPM FLOW display to 9 9 LPM Set the OXYGEN display to 50 Turn off the oxygen gas supply to the unit When the gas runs out check for each of the following the OXYGEN FAILURE alarm illuminates the audible alarm sounds the flow indicators are off the LPM FLOW and OXYGEN displays are off Turn on the oxygen gas supply and the unit should return to normal operation The alarm may continue to chime for up to 20 seconds after restoration of gas pressure Nitrous Failure Test Set the LPM FLOW display to 9 9 LPM Set the OXYGEN display to 30 Turn off the nitrous oxide gas supply to the unit When the gas runs out make sure each of the following occurs the NITROUS FAILURE alarm illuminates the audible alarm sounds the LPM FLOW display indicates the oxygen flow being delivered the OXYGEN display is OFF the N O gas flow indicator is OFF the Os gas flow indicator shows at least 3 bars Turn on the nitrous oxide gas supply The unit should return to normal operation The alarm may continue to chime for up to 20 seconds after restoration
17. tment as shown in Figure 4 3 Remove each blown fuse from its clip and replace it with a 5mm x 20mm cartridge fuse rated 2 5 amp 250 volt slo blo time delay part number 63882537 Two fuses are required for the unit to operate Fuse Compartment Open Figure 4 International Fuse Replacement Remove Fuse Compartment Here Fuse Replacement Domestic 115 120 V 1 To replace a blown fuse turn the unit off disconnect power to the unit by unplugging the power cord from the wall and then remove the power cord from the input connector on the rear of the unit 2 Remove the fuse compartment as shown in Figure 5 3 Remove the blown fuse from its clip and replace with a 5mm x 20mm cartridge fuse rated 2 5 amp 250 volt slo blo time delay part number 63882537 Figure 5 Domestic Fuse Replacement Specifications Physical Nitrous Oxide Inlet Dimensions 8 W x 5 5 H x 10 D Pressure Requirements 50 to 55 psi Weight 6 lbs Flow Requirements 10 LPM minimum flow Fittings Gas Delivery Fresh Gas Outlet 15mm ID x 22mm OD Oxygen Flush 10 to 30 LPM 20 LPM nominal 50 psi Nitrous Oxide Inlet Male DISS CGA 1040 input Oxygen Inlet Male DISS CGA 1240 Minimum Nitrous Oxide Concentration 00 Maximum Nitrous Oxide Concentration 70 Environmental Minimum Oxygen Concentration 30 Storage Temperature lO F to 120 F Maximum Oxygen Concentration 100 17 C to 48 C Allow to stabilize to room temperature Flo
18. w Range 100 Oxygen 1 0 to 9 9 LPM before operating Flow Range Any Mixture up to 9 9 LPMT Operating Temperature 72 F nominal 22 C tLow end flow limited by 1 0 LPM oxygen limit Humidity Ambient non condensing Electrical Domestic 115 120 V Gas Supply Input Voltage Supply 115 VAC nominal Oxygen Inlet Input Line Frequency 60Hz Pressure Requirements 50 to 55 psi Circuit Protection 2 5 amp time delay fuse Flow Requirements 30 LPM minimum flow Matrx PN 63882537 Note A minimum oxygen flow of 120 LPM is Electrical International 220 240 V required when using the optional Demand Valve Input Line Frequency 50 60Hz Resuscitator Circuit Protection two 2 5 amp time delay fuses Matrx PN 63882537 Performance and Accuracy Controlled Variable 50 55 PSIG Sources Oxygen Flowrate from 1 0 to 9 9 0 5 LPM Nitrous Oxide Flowrate from 1 0 to 7 0 LPM 0 5 LPM Nitrous Oxide Flowrate from 0 1 to 1 0 LPM 0 5 0 9 LPM Percent O2 5 points N20 gt 1 0 LPM Percent O2 20 10 points N20 lt 1 0 LPM Pure Oxygen Flush 20 LPM Nominal at 50 PSIG Input Check out our website www porterinstrument com for the following topics Flowmeter Mounting Options Flowmeter Accessories Product Warranty and Registration And Downloading User Manuals 10
19. wmeter are diameter indexed 3 8 O D for Nitrous Oxide and 12 for Oxygen The cross protection system is designed to prevent misconnection of Oxygen and Nitrous Oxide piping DO NOT ATTEMPT TO CHANGE THE DIAMETERS OR CONNECTORS OF THE FLOWMETER Tampering with the cross protection system constitutes acceptance of liability by the installer For your own protection as well as that of the Doctor and the patients use 3 8 O D tubing for all Nitrous Oxide lines and 1 O D tubing for all Oxygen lines To assure safe operation and conformation to local fire codes all Porter Instrument flowmeter systems are designed to be used with sedation delivery systems mounted inside walls and they meet or exceed the guidelines established by the National Fire Protection Association for Nonflammable Medical Gas Systems NFPA 99 Copies of NFPA 99 or portions thereof may be obtained by writing to National Fire Protection Association Batterymarch Park Quincy MA 02269 9904 or call 1 800 344 3555 WARNING New or modified installations properly connected gas pipelines are absolutely essential to patient safety The authorized distributor or contractor should provide written documentation that all gas pipelines are connected properly and that the system has been pressure tested prior to use While this is a good business practice it is important that the user verify by their own test independent of the authorized distributor or contractor t
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