Nitronox HD User Manual
Contents
1. black Knob is used to open close Cylinder Valves Fig 21 See FM 916 User s Instructions Description of Unit The Nitronox is an inhalation analgesia system designed to deliver a fixed concentration of 50 nitrous oxide and 50 oxygen on the demand flow principle Nitronox operates either on pipeline gas supply using a Mobile Stand or Wall Mount or medical E or D size cylinder supply by means of a small cylinder yoke block with regulators Mobile E Stand The Nitronox is available in various configurations offering three mounting styles 1 Nitronox with Mobile Stand only for use with pipeline gas supply only 2 Nitronox with Mobile E Stand Fig 22 and cylinder mount 2 nitrous oxide and 2 oxygen E or D size Refer to FM 916 for Installation and User Instructions 3 Nitronox with wall mount for use with pipeline gas supply Use Nitronox in conjunction with Nitronox HD Scavenger System Refer to User s Manual Instructions FM 1309 Fig 23 Fig 23 Nitronox Front Cover with Mixture Pressure and N O and O Line Pressure Gauges Fig 22 Nitronox with Mobile E Stand 13 Nitronox Inhalation Analgesia System FUNCTIONAL SCHEMATIC Nitrous Oxide No0 Cylinder Supply Mixture Press Control Adjust Screw with Oxygen 07 Cylinder Supply Lock Nut Ae A Ime OX NoO Cyl Valve SC 02 Cyl Valve N20 Cyl D 2X Oo2. Cyl Press Gauge Press Gauge NoO Cyl Press nee 02 Cyl CLL Regulator 50 55 PSI wr UL Press Regulator sae 50 55 PSI NoO Line Os Line Press Gauge Vent Vent Press Gauge Check Valve NO Check Check Valve Valve Q NoO External 4 Gas Supply 40 65 PSI 02 amp 5 SUPP Mixture 40 65 PSI Press Regulator Mixer F ag Fa NoO 2 Preset Preset Orifice Mixture Orifice 9 Press Gauge 30 35 PSI Whistle if Al mn Ike a s e A e a Demand Valve With LIT I Exhalation Valve h To Face Mask and Patient 14 Alarm Actuator Specifications Functional Features Gas Supply Duration E Size Cylinders At Normal Breathing Rates N2O Approximately 6 6 5 Hrs Flow Capability 114 LPM Maximum Mixture Concentration Mixture Concentration Factory Adjusted 50 N20 and 50 Ox O Approximately 2 2 5 Hrs Oxygen Fail Safe If apparatus oxygen line pressure is depleted or disconnected nitrous oxide flow and demand valve flow stops automatically If apparatus nitrous oxide line pressure is depleted or disconnected demand valve will continue to function providing 100 oxygen at reduced flow capacity of about 55 LPM If patient takes repeated shallow breaths oxygen concentration automatically increases 65 O2 minimum at input pressures 45 psi to 60 psi Mixer Pressure Alarm A whistle will sound when a gas mixture regulator seat malfunction affecting mixture concentra
3. Oxygen is a true compressed gas while in the cylinder thus the cylinder pressure gauge can be used to determine the amount of gas remaining in the cylinder For example 2000 psi indicates full 1000 psi indicates half full etc Nitrous Oxide is a liquefied compressed gas that vaporizes in the cylinder thus the cylinder pressure gauge cannot be used to determine the amount of gas remaining in the cylinder until all liquid in the cylinder vaporizes While liquid remains in the cylinder the cylinder pressure gauge indicates the vapor pressure which depends on and varies with the temperature of the liquid For example at 68 F 20 C the vapor pressure is about 750 psi 50 bar at 20 F 7 C it drops to about 400 psi 30 bar while at 90 F 32 C it increases to about 1000 psi 70 bar After all the liquid vaporizes the pressure will decrease normally as the gas is withdrawn and the cylinder pressure gauge can then be used to determine the amount of gas remaining in the cylinder Cautions e Always turn on CYLINDER VALVES slowly and fully E cylinder yoke models e Hex hole in cylinder valve wrench to be used only to tighten cylinder valve packing nut in event of a leak e NEVER ATTEMPT TO LOOSEN cylinder valve packing nut If valve stem is tight return cylinder to supplier Warning Do not remove or alter gas indexing pins Good practices Cylinders with E Stand 1 Two cylinders of Os and two cylinde
4. disposable full face mask DEHP free and Latex free that is biocompatible for medical use Follow manufacturer s instructions The disposable mask materials have been chosen by the medical device manufacturers of the masks intended for medical usage Many establishment protocols also call for the use of a bacterial filter Follow manufacturer s instructions Continuous flow vs demand flow devices Equipment to deliver nitrous oxide and oxygen sedation are often categorized as demand flow or continuous flow devices The Nitronox is a demand flow device Different specific delivery protocols will be established for the two categories of equipment The differences center around self administration for demand flow devices vs direct administration by medical professionals for continuous flow devices Also continuous flow devices typically allow the administration of variable concentrations of nitrous oxide and variable flow rates of delivered mixture However some establishments have developed specific protocols for delivery with continuous flow devices where the medical professional is able to adjust to deliver various percentage mixes where with supervision the delivery could be described as self administration in that the patient will hold the full face mask to the face 5 SELF ADMINISTRATION VS ASSIST TO SELF ADMINISTRATION WARNING Encourage patient to self administer Self administration is a safety feature of the demand flow Nitro
5. parts Stainless steel Fasteners Steel brass and aluminum all plated for corrosion resistance Rubber parts except hose Silicone Maintenance Cleaning specific to the demand valve for disassembly of components the procedures must be performed in a hydrocarbon residue free area because of the danger of soontaneous combustion when the residues are exposed to nitrous oxide WARNING Since the described cleaning procedures for the demand valve call Standard Cleaning and Disinfecting After Use 1 Remove unscrew the outlet adapter housing mask connection outlet and remove lift the exhalation valve assembly with attached flapper valve from the main demand valve subassembly Do not remove the hose assembly 2 Clean all foreign matter from the adapter housing exhalation valve assembly and outside surfaces of main demand valve subassembly with mild soap solution being careful not to get any liquid inside the demand valve subassembly Rinse the parts thoroughly in clean water 3 Carefully examine the three assemblies of the demand valve Discard and replace any cracked or damaged parts Contact Porter for replacement assemblies 4 Disinfect the demand valve and collection manifold Cold Disinfecting 1 Remove the outlet adapter and the exhalation valve assembly from the demand valve assembly as described above Clean the outlet adapter and the exhalation valve assembly using a disinfecting solution approved by your f
6. 2220002020 Rennen 6 Demand vYalve Insitielons wessen 7 Installations Preparation of Mobile E Stand u0 2u00240002n0 nenn nenne nenn nennen 9 Installations Preparation of Nitronox Scavenger Parts 2 002200220022n nenne 11 Installations Attachment Of Cylinders ccceccceeccseeeceeeeceeeeeeeeseeeeseeeeseeeseeeeseeeeaes 12 DCSCHD HOM erregen 13 Functional Schemalle asus 14 Specifications Functional Features u2220002000020n0enennnnnnnenennn nenn enennennnnn 15 Functional Warnings and Cautions 2u002240002nnennennennnnn nenne nenne nnnnnenenne nennen 15 PUIG OMA MOSS ee ee ee ee an ee ee ee 15 Operation Maintenance ie U 16 1rOUDIESNOOUNG an ls 20 WA A AML ren ee nseeen 21 Examination Examine shipping carton for signs of external damage Remove contents from carton and inspect for visible damage or missing parts If damage is discovered or suspected and or parts are missing notify Porter or authorized distributor immediately IMPORTANT READ MANUAL COMPLETELY BEFORE OPERATING THIS DEVICE 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 N WARNINGS AND PRECAUTIONS These warnings and precautions are to help you to understand h
7. 40 psi 2 8 bar If this cannot be achieved discontinue use of apparatus and notify authorized distributor immediately Wrench Adjust Screw Lock Nut 7 16 Hex Mixture Pressure Control Adjustment Screw Screwdriver Fig 26 Alarm Actuator Fig 27 Back of Case Upper adjustment access Temporary mixture pressure Fig 28 adjust range Maintenance 5 Cleaning Methods We recommend the use of an approved disinfectant for the dental medical environment for cleaning the outside of the Nitronox demand valve and accessories Do not spray disinfectant directly onto housing Spray disinfectant into disposable towel and wipe unit thoroughly removing excess disinfectant to eliminate buildup Follow the manufacturer s directions for use Introduction of moisture or other contaminants into this device may result in defective operation Never oil or grease any part of this system minimize fire or explosion potential See special demand valve cleaning instructions 6 Replacing the E Stand Check Valve see FM 916 E Stand for illustrations and instructions for replacement of the Check Valve Assembly A Field repair of the Nitronox is limited to maintenance adjustments and replacement parts obtained through Porter All other repairs should be performed by an authorized Porter service representative Although the materials contained in the Nitronox Inhalation Analgesia System do not have a specified shelf l
8. Parker Hannifin Corporation Porter Instrument Division 245 Township Line Rd Porter Hatfield PA 19440 USA 215 723 4000 fax 215 723 5106 NITRONOX HD USER S MANUAL INSTRUCTIONS FM 1308 Rev 10 2014 www porterinstrument com nitronox Manufacturer ul Porter Instrument Division Parker Hannifin Corporation 245 Township Line Road Hatfield PA 19440 Office 215 723 4000 Fax 215 723 5106 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 Professional 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 Nitronox Inhalation Analgesia System Serial Number Table of Contents EIN TIOMN ations Scat ds Gates T St Aart Ae siete Ma ehe 1 Wai ins and FP FEGAUTIONS nennen 2 New or Modified Installations au una ee a ei 3 side Effects 7 Gontraindiealions anna 4 Development of Nitronox Delivery Protocols u02240404044n nennen nennen nennen 5 Self Administration vs Assist to Self Administration 00
9. RANTY THIS WARRANTY IS GIVEN IN PLACE OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE Under no circumstances shall Parker Hannifin Corporation be liable for incidental or consequential damages as those terms are defined in the uniform commercial code Parker Hannifin Corporation Porter Instrument Division warrants that each product or part shall be free from defects in workmanship and materials under normal use and with appropriate maintenance for one 1 year from the date of delivery to customer unless otherwise specified in writing All rubber and plastic parts and accessories are warranted under the same conditions for a period of ninety 90 days from date of purchase No statement or claim about the product by any employee agent representative or dealer of Parker Hannifin Corporation shall constitute a warranty by Parker Hannifin Corporation or give to rise to any liability or obligation of Parker Hannifin Corporation Parker Hannifin Corporation shall not be liable for any damage injury or loss arising out of the use of the product whether as a result of a defect in the product or otherwise if prior to such damage injury or loss the product was 1 damaged or misused 2 repaired altered or modified by persons other than Parker Hannifin Corporation 3 not installed in strict compliance with applicable codes and ordinances or 4 not installed by an authorized Pa
10. VALVE INSTRUCTIONS Description The demand valve of the Nitronox Inhalation Analgesia System is designed to be used with a full face mask Porter recommends a standard single use disposable mask not supplied sterile DEHP free Latex free with materials chosen by the manufacturer for biocompatibility in a medical setting for administration of nitrous oxide to a breathing patient It contains no buttons or levers to force the gas into the patient and is for self administration Do not strap mask on patient Allow the patient to hold the mask over the nose and mouth to self administer Upon inhalation the demand valve opens and the nitrous oxide oxygen mixture will Start to flow Ceasing to inhale or if the patient stops breathing the valve automatically closes to stop the flow of the nitrous oxide oxygen mixture WARNING Do not use near open flame or in an unventilated area Can accelerate burning and be toxic Specifications Flow The demand valve through the Nitronox housing is to be connected to a nitrous oxide supply capable of delivering a minimum of 100 LPM 40 90 psig 2 8 6 2 bar The valve itself 160 LPM set flow As required in demand mode 0 160 LPM at 40 psig Inlet fitting Standard male DISS Filter 2 micron sintered stainless steel Outlet 22 mm outside diameter x 15 mm inside diameter fits standard medical masks Materials Housing and plastic parts Noryl polyester polysulfone Moving and adjusting
11. acility Refer to Manufacturer s Recommendations Do not allow any solution inside the demand valve subassembly 2 Remove the outlet adapter and the exhalation valve assembly from the solution and rinse thoroughly with sterile water Rinse repeatedly to be sure that all of the solution is removed from the parts 3 Check the exhalation valve assembly to be sure the flapper valve is not twisted WARNING If the flapper is twisted or not properly positioned the demand valve will not function properly Make sure that the flapper valve lies flat against its seat 4 Reassemble the parts Maintenance Replacement Parts Outlet Adapter Housing Exhalation Valve Assembly Sintered Stainless Steel Filter Recommended Overhaul Period The demand valve should be overhauled annually Contact Porter for details WARNING Do not disassemble or tamper with the main demand valve subassembly AN This will void the warranty Improper disassembly or improper assembly procedures may alter the performance of the valve which could cause serious injury to the patient In case of malfunction return the demand valve to Porter immediately Installations Nitronox Main Housing Mobile E Stand Fig 1 1 Mobile Stand Wall Mount Fig 1 2 Mounted Demand Valve Scavenger Interface Preparation of Mobile E Stand Fig 1 1 4 Secure the Housing on the Mounting Post Also see FM 916 E Stand User s Instructions Fig 5 1 by twisting the Post counterclockwi
12. age 3 for details After use turn off Cylinder Valves store Demand Valve with Hose Dispose of single use mask not supplied sterile Models Using Pipeline or External Gas Supply Mobile Stand or Wall Mt 1 2 3 4 Connect external gas supply hoses to DISS Diameter Indexed Safety System fittings External pressure must be 40 65 psi 2 8 4 5 bar preferably 50 55 psi 3 4 3 8 bar Observe external pressures on apparatus LINE PRESSURE GAUGES WARNING DO NOT use Nitronox if O2 input exceeds N2O input by 15 psi 1 bar or higher Observe mixture pressure as in step 4 above Follow step 5 procedure above After use disconnect external gas supply 17 Fig 25 3 Maintenance 1 4 Line Pressure Adjustment Green Band for Model Using Mobile E Stand Locate appropriate PRESSURE REGULATOR blue lettering nitrous oxide green lettering oxygen remove 9 16 acorn nut insert 5 32 hex socket key and adjust pressure to within green band Mixture Pressure Control Adjustment Green Band Remove LOWER CHROME PLUG from case back With wrench loosen 716 inch hex nut counterclockwise approximately one quarter turn Insert screwdriver through access hole in bottom of case into slot of adjusting screw While holding nut with wrench adjust counterclockwise to increase pressure clockwise to decrease After adjustment tighten nut while holding screw in position with screwdrive
13. ife Porter advises a factory performance check and repair procedure every 2 years It is Porter practice to recommend a complete factory elastomer change out after every 10 years of product operation in the field Following this schedule of maintenance and repair will assure a useful product operation field life of 15 years or more Also to assure a long useful product operation field life perform the periodic field performance tests and adjustments including the Line Pressure Adjustment the Mixture Pressure Control Adjustment the Leak Testing of the System and the Whistle Alarm Actuator Adjustment Perform the specific cleaning procedures for the Demand Valve It is advisable to overhaul the Demand Valve annually Note In the Nitronox HD Scavenger System User s Manual Instructions FM 1309 the maintenance is to replace the foam resistor every 6 months 19 Troubleshooting PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION Replace with Porter part No A 3399 000 4 per Unit Leakage at YOKE CYLINDER VALVE connection Low or no reading on CYLINDER GAUGE with CYLINDER VALVES open O2 cylinder or external supply used too quickly Line pressure out of green band Mixture pressures out of green band WHISTLE ALARM failure during functional test 7 WHISTLE ALARM sound Note a momentary chirp sound is acceptable upon initial application of pressure if whistle then stops reseats Missing or defective yoke sea
14. include General Pain Management Labor and Delivery Wound Debridement Fracture Reduction Catheter Insertion Foreign Object Removal Setting Broken Bones Lacerations Botulinium Injection Barium Enema Joint Injections Gastrostomy Sutures IV Starts CT Scans The Nitronox Inhalation Analgesia System is considered transient less than 60 minutes in terms of continuous use when providing Analgesia pain management Minimal Sedation or Moderate Sedation However a procedure or medical condition that occurs over the course of many hours also is considered to be using transient delivery in that given self administration techniques the patient will be unlikely to hold the face mask to the face continuously for over 60 minutes For example a woman in labor may safely use Nitronox in a transient self administration mode over the course of several hours as secondary labor and end labor stages are experienced The upper limit of the number of hours of this described transient delivery is at the determination of the medical professional Patient Population Adult and Pediatric Used to deliver a gas mixture to a conscious spontaneously breathing patient who is awake alert and cooperative and requires relief from moderate to severe pain and is under the continuous supervision of a healthcare professional Age Weight limitations see Relative Contraindications at the determination of medical professional Note Porter recommends the use of a
15. l washer models with E cylinder yoke damaged pins Cylinder pressure too low or cylinders empty models with E cylinder yoke O2 cylinder valve or external supply left on after use and natural bleed depletes cylinder or external supply O2 cylinder contains up to 2 5 hrs breathing supply N20 cylinder contains up to 6 5 hrs Apparatus exposed to temperature below 32 F 0 C PRESSURE REGULATOR out of adjustment models with E cylinder yoke PRESSURE REGULATOR defective models with E cylinder yoke CONTROLLED PRESSURE REGULATOR section of mixture requires adjustment REGULATOR malfunction models with E cylinder yoke ALARM ACTUATOR out of adjustment ACTUATOR DEFECTIVE Leak at N2O pressure control seat causing low O2 concentration ACTUATOR DEFECTIVE 20 Replace cylinder with full cylinder of appropriate gas Use practice of turning off cylinder or external supply after use Expect higher usage of O2 cylinders Allow apparatus to return to room temperature before making adjustment See Maintenance adjustment Step 1 Discontinue use and notify authorized distributor See Maintenance adjustment Step 2 Discontinue use and notify authorized distributor See Maintenance adjustment Step 3 Discontinue use and notify authorized distributor Discontinue use and notify authorized distributor CERTIFICATE OF WAR
16. linder When In Use Os cylinder is depleted the Oxygen Fail Safe will stop N O flow and demand valve flow automatically When In Use NO cylinder is depleted the Nitronox will deliver 100 Os through the Demand Valve After use turn off cylinder valves Caution With O cylinder turned on the Nitronox will have an intentional small O bleed which will tend to deplete the O cylinder if after use the O cylinder valve is left on Models With E Cylinder Yoke Simple Operation Procedure 1 Open one each Os and NO Cylinder Valves with wrench provided Observe cylinder pressures Replace cylinder when less than 300 psi 20 bar at room temperature 21 1 C 70 F During replacement close all Cylinder Valves Observe line pressures Figs 25 1 25 2 Normal is 50 55 psi 3 4 3 8 bar green band for static no flow condition Pressure will decrease slightly during each inspiration see Maintenance Observe mixture pressure Fig 25 3 Normal is 30 35 psi 2 0 2 4 bar green band for static no flow condition Pressure will decrease Slightly during each inspiration see Maintenance lf all pressures are normal Nitronox is ready to use Remove Demand Valve with Mask from storage bracket Instruct patient to hold Mask lightly on face covering nose and mouth Instruct to breathe normally preferably through nose Encourage patient to self administer at all times see Warnings p
17. nox in that if for any reason the patient becomes over sedated the patient will be unable to successfully hold the mask in a tight seal position on the face The result will be that the mask falls away from the face and the demand flow will cease allowing the patient to breathe room air in through the mouth or nose WARNING If a patient is unable to fully self administer and the medical professional provides an assist to placement of the mask in a sealing position on the face maintain patient observation to prevent over sedation under any conditions Discontinue the assistance in mask placement immediately upon any observation of over sedation remove the mask from the face entirely Never use a mask strap to hold the mask to the face Never force the mask on the face the patient must always be spontaneously breathing At the determination of a medical professional as an added precaution for procedures where an assist to self administration is used the medical establishment may elect to continuously sample the mixture delivery downstream from the demand valve by installation of an oxygen analyzer Self administration for pediatric patients Some establishments have developed specific protocols instructing the provider to administer assisted mask application of Nitronox nitrous oxide to pediatric patients typically ages 1 to 4 The concept that for certain circumstances the use of the Nitronox or the use of other demand valve delive
18. otential WARNING N NEW OR MODIFIED INSTALLATIONS ALWAYS ASSURE THAT LINES ARE NOT CROSSED WARNING New or modified central supply 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 that 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 Do not allow crossed lines to defeat the safety features of the Nitronox and or central gas supply manifold systems Crossed lines will create a dangerous and hazardous condition where under a loss of oxygen supply 100 nitrous oxide will be delivered through the oxygen delivery path and subsequently to the patient Maintain patient observation during procedures Prevent over sedation If a patient becomes over sedated when being delivered 100 oxygen during an apparent loss of nitrous oxide supply it is a definite indication of crossed lines If crossed lines are suspected remove the mask immediately and encourage mouth breathing Deliver pure oxygen from an oxygen demand valve only if the oxygen source is independent from
19. ow to safely operate the Nitronox device A WARNING alerts you to a possible hazard to people A CAUTION alerts you to the possibility of equipment damage WARNING New or modified installations properly connected gas pipelines are absolutely essential to patient safety The ultimate responsibility of assuring that lines are not crossed rests with the user See next page for details WARNING Porter equipment utilizes the cross protection system The flexible hose and connectors that connect to the housing are diameter indexed 3 8 O D for Nitrous Oxide and Y2 O D for Oxygen The cross protection system is designed to prevent misconnection of Oxygen and Nitrous Oxide hoses DO NOT ATTEMPT TO CHANGE THE DIAMETERS OR CONNECTORS OF THE DEVICE Tampering with the cross protection system constitutes acceptance of liability by the installer WARNING Nitronox Inhalation Analgesia systems are intended to be used by medical personnel trained in its use and the use of nitrous oxide and oxygen for medical applications 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 Use Scavenging Monitor for N2O in the patient treatment area to insure that controls are effective in achieving low levels of ppm parts per million exposure Contact Porter or Authorized Distributor for details on monitors and testing Inspec
20. patients taking antidepressant or psychotropic drugs psychologic impairment patient who has taken medication to induce sleep Decompression injuries increased intracranial pressure increased intraocular pressure intraocular surgery bowel obstruction middle ear surgery emphysema pulmonary hypertension and others Current upper respiratory tract infection chronic obstructive pulmonary disease COPD cystic fibrosis shock acute pulmonary edema APE pneumothorax and major chest or maxillofacial trauma bleomycin therapy recent pneumoencephalography Pregnancy first trimester patient may wish to contact OBGYN medical professional Development of Nitronox Delivery Protocols It is the responsibility of the medical establishment and the medical professional to develop and establish specific delivery protocols The Nitronox Inhalation Analgesia System is designed to deliver a fixed concentration of 50 nitrous oxide and 50 oxygen on the demand flow self administration principle The medical professional will turn on and observe the operating indicators of the device In order to receive the analgesic the patient will self administer by holding the face mask firmly in place during the procedure With the face mask sealed every time the patient takes a breath the patient inhalation will open the demand valve and deliver the mixed gas through the face mask Common procedures conducted with Nitrous Oxide Oxygen Sedation
21. r see illustration Fig 26 Leak Test System Monthly Check of working pressure leaks Verify hoses are attached from E Stand to Nitronox Housing Turn one O and one N2O cylinder on Verify E Stand pressure gauges read cylinder pressures Verify Nitronox line pressure gauges read within green band Note fail safe is open and pressure reaches Demand Valve Turn off N20 cylinder valve Verify that N2O E Stand gauge reads about 750 psi 50 bar Note exact needle position Verify that there is little or no movement up to 2 increment of the exact needle position in 15 minutes Nitronox NO line pressure gauge needle will stay in green band with no movement Turn off Os cylinder valve It is normal that needle of O E Stand gauge will drop Nitronox Os line pressure gauge needle will stay in green band with no movement will eventually drop after E Stand gauge pressure naturally depletes Whistle Alarm Actuator Adjustment Remove UPPER CHROME PLUG from case back Fig 27 With mixture pressure temporarily adjusted per Step 2 Maintenance in middle of range shown Fig 26 insert 1 8 hex key not provided into adjustment screw at end of ALARM ACTUATOR Adjust screw either clockwise or counterclockwise until whistle sounds clearly DO NOT over adjust Return mixture pressure to middle of green band Whistle sound must stop with pressure in green band and whistle must sound with pressure in range shown in Fig 28 about
22. rker Hannifin Corporation dealer Parker Hannifin Corporation s obligation for breach of this warranty or for negligence or otherwise shall be strictly and exclusively limited to the repair or replacement of the product or part This warranty shall be void on any product on which the serial number has been altered defaced or removed ORDERS All orders are to be made through authorized Parker Hannifin Corporation distributors All billing will be done through said distributors Direct orders will be handled through the authorized local dealer as determined by Parker Hannifin Corporation RETURNS All returned merchandise will be handled through the local Parker Hannifin Corporation distributor No returns will be accepted unless authorized in writing by Parker Hannifin Corporation and accompanied by the original shipping invoice All returns are subject to restocking charge Policies subject to change without notice The Quality System for Porter is certified to ISO 13485 The scope of our registration is The design manufacture distribution and servicing of Nitrous Oxide Oxygen Sedation Flow Meters Gas Scavenging Systems Steam Sterilizers Gas Distribution and Office Communication Systems for use by a physician dentist or licensed healthcare professional 21
23. rs of NO are typically connected at all times Exception When using external gas supply of oxygen the E Stand may be populated with NO cylinders and O cylinders are not placed on E Stand 2 Minimize leak risks Confirm Yoke Washers are in place before replacing mounting cylinders Use Porter A 3399 000 replacement washers once yr Have spare washers 16 10 11 12 Minimize leak risks With cylinder in position rotate swivel arm and move into secure locked position when Tee Handle is tightened To prevent movement and potential damage to yoke pins always fasten the Hook amp Loop strap restraints around cylinders Assure E Stand is populated with at least one full cylinder of O2 and N2O before starting any procedure Label each cylinder with a tag or sticker indicating In Use and Full Full is reserve cylinder Use Cylinder Valve Wrench to open the In Use cylinders of O and N20 Verify wrench is attached to Block Cylinder pressure gauges on Block provide a visual indication of cylinder status see details on Cylinder Pressure Readings Caution If all four cylinders or both cylinders of one gas are open the two cylinders of Os and N O will deplete in tandem The Full cylinder will empty with the In Use cylinder and will not be available as a future spare When In Use cylinder is depleted open the spare Full cylinder Close valve on empty cy
24. ry systems should have a protocol where the provider administers the nitrous oxide as opposed to complete self administration is in potential conflict with protocols for labor analgesia where there is an emphasis on self administration It is the responsibility of the medical establishment and the medical professional to develop and establish specific delivery protocols Self administration for laboring women Establishments that have developed specific protocols for laboring women often include a particular emphasis on self administration and education for the laboring woman and for her support persons on the techniques of self administration In these specific protocols the establishments have concluded that nitrous oxide can only safely be self administered by the laboring woman with support persons needing to be educated that they absolutely cannot assist in the delivery of nitrous oxide by holding the mask up to the laboring woman s face since an integral safety feature of nitrous oxide use is that when the woman has physiologically reached her limit of nitrous oxide intake she will no longer be able to hold the mask up to her face for more thus self regulating the intake The establishments have concluded that when someone else is allowed to hold the mask up to her face the potential risk of losing consciousness increases dramatically Thus there is an initial and repetitive education for the laboring women and support persons DEMAND
25. se with one hand and 1 Slide Center Column with Cylinder holding the Housing steady with the other Restraint and Cylinder Yoke Block into 5 hand Twist until the Post is snug Fig 5 2 Star Base Fig 2 1 Push down firmly until snug Align Cylinder Restraint as shown Base of cylinders will fit in between wheels Fig 1 1 Fig 2 2 Fig 1 2 Fig 2 1 Fig 2 2 2 Adjust the Recessed Mounting Post to highest height by loosening and tightening the small black handle Fig 3 1 on the Yoke Block and raising the Mounting Post Fig 3 2 Wall Mount Fig 3 2 3 The Nitronox Main Housing will mount on the Mounting Post of the E Stand or Mobile Stand by sitting the bottom of the Housing Fig 4 1 on top of the Mounting Post larger threads Fig 4 2 Hold the Mounting Post in one hand and position the Housing with the other Fig 5 1 Fig 4 2 Preparation of Mobile E Stand continued 5 Attach the Handle Fig 6 1 to the Mounting Post just under the Retaining Ring O ring Fig 6 2 Firmly tighten both screws so that the Handle cannot be twisted The back of the Handle should be positioned over the back two cylinders Fig 6 3 6 Carefully clip the shipping accessory plastic fasteners off of the green Oxygen Hose and blue Nitrous Oxide Hose under the E Stand Block Fig 7 Be careful do not cut the Hoses Fig 7 10 Connect the Diameter Indexed Safety S
26. t and maintain the analgesia delivery system to prevent N2O leaks in all hoses connections and fittings Have all leaks repaired immediately WARNING Medical workers are exposed to N20 during administration of N2O O2 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 accessory Porter Nitronox Scavenger System is an important part of the system of controls in medical settings WARNING When using a single use full face mask not supplied sterile Dispose of mask after use to prevent patient cross contamination When using multiple use mask follow manufacturer s Sterilization instructions 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 p
27. tch or pinch fingers 15 Loosen the Tee Handle Fig 16 1 until point is even with the inside of the Swivel Arm Push Tee Handle inwards to flip to open position Align Tee Handle vertically Fig 16 2 16 17 18 Undo the Hook amp Loop straps on the Cylinder Restraint Fig 17 Fig 17 Cylinder Preparation Remove any plastic wrap from the top of cylinder including the cylinder plastic washer Verify that the rubber washer Fig 18 2 provided with the E Stand is still in place Use the E Stand washer Mount the E cylinders of Oxygen and Nitrous Oxide not included to the E Stand Block Insert cylinders correctly on indexing pins and as marked on Block N20 Figs 18 1 18 2 Oo Figs 18 3 18 4 Pins assure mounting in appropriate position N20 Pins Fig 18 2 Rubber Washer 21 Fig 18 3 Warning Do not remove or alter gas indexing pins Slide the cylinder into place by lining up the pins and pin holes on the cylinder Push into place Properly placed the cylinder should hang on the pins Fig 19 Cylinders should hang freely between wheel base If the wheel base interferes loosen and rotate cylinder restraint Rotate swivel clockwise to close Fig 20 1 Swivel will move into the locked position when Tee Handle is tightened Secure the Hook amp Loop straps to hold cylinder in place Fig 20 2 22 The Cylinder Valve Wrench hanging from 12
28. the suspected crossed lines area INPUT PRESSURE DIFFERENCES WARNING DO NOT use Nitronox if O2 input exceeds N20 input by 15 psi or higher SIDE EFFECTS amp CONTRAINDICATIONS Note This is not an exhaustive list The list was prepared from published articles Possible Side Effects of Nitrous Oxide Oxygen Conscious Sedation May experience nausea vomiting excessive sweating euphoria excitement deep sedation drowsiness sleep dizziness lightheadedness dysphoria amnesia and headaches Precautions and Contraindications for Nitrous Oxide Use Precautions Relative Contraindications Discontinue the Nitrous Oxide delivery if observed prolonged inspirations irregular breathing involuntary eye movements swallowing or gagging dilated pupils and rigid muscles Side effects e g nausea vomiting dizziness dysphoria etc are not tolerable Current vitamin B gt deficiency Bronchoconstrictive disease asthma at determination of medical professional The use with pediatric patients especially age 1 to 4 years requires caution and specific protocols developed by the medical professional upper age limit at determination of medical professional Weight limitations at the determination of medical professional Contraindications Inability to hold own face mask impaired oxygenation or hemodynamic instability Acute drug or alcohol intoxication or impaired consciousness head injury endocrine or metabolic disease
29. tion has occurred Warning Nitronox Inhalation Analgesia systems are intended to be used by medical personnel trained in its use and the use of nitrous oxide and oxygen for medical applications AN Warnings e DO NOT use Nitronox if either line or mixture pressure is out of green band see Maintenance Figs 24 1 24 2 Fig 24 1 Fig 24 2 e Encourage patient to self administer at all times see Warnings page 3 for details 5 Percentage Points O AN Warnings e If WHISTLE ALARM sounds discontinue patient use immediately and shut off gas supply e WARNING DO NOT use Nitronox if O2 input exceeds N2O input by 15 psi 1 bar or higher see Warnings page 3 Functional Tests Prior to first use and periodically thereafter monthly is suggested perform the following tests Whistle Alarm Actuation 1 Increase mixture pressure per Page 7 Step 2 Maintenance until gauge reading is in RED Do Not Use area per gauge illustration WHISTLE should sound in this range lf WHISTLE sounds before or after this range WHISTLE ALARM ACTUATOR must be adjusted see Maintenance Fail Safe Check Out Test 1 With unit in operation one each O2 amp N2O gas supplies on turn off or disconnect oxygen at supply source 2 As oxygen pressure falls to zero as read on oxygen line pressure gauge demand valve flow must stop completely Operation Maintenance Cylinder Pressure Readings
30. ystem DISS color coded green white Oxygen and blue Nitrous Oxide Hoses to the appropriate connections Fig 8 1 on the bottom of the Nitronox Main Housing Slide the Hoses through the opening in the Handle Fig 8 2 before connecting Firmly tighten the Hoses using a wrench Fig 8 1 Fig 8 3 Preparation of Nitronox HD Scavenger Parts for use with Porter Medical 12 Attach Mask Hanging Bracket to the Left Breathing Circuit side of the Nitronox HD Fig 13 For further details refer to Nitronox HD Scavenger System User s Manual FM 1309 and Porter Medical Breathing Circuit FM 1304 8 Attach Demand Valve Manifold Mount Assembly to the right side of the Nitronox HD using one screw on the top Fig 9 1 and one screw on the bottom Fig 9 2 Fig 13 13 Assembled Nitronox HD unit Fig 14 Fig 9 1 Fig 9 2 9 Push Demand Valve into Manifold two sealing o rings Fig 10 Fig 10 10 Tighten thumb screw of Retaining Bracket Fig 14 to the side of the Manifold to secure the Demand Valve Fig 11 14 Attach the Nitronox Scavenger Interface to the Center Column Figs 15 1 15 2 gt Fig 12 11 Connect the Gas Delivery Hose to Demand Valve Fig 12 This is a quick connect attachment Push the two ends together until click sound is heard To remove push the metal clip in and pull apart Attachment of Cylinders Caution When operating the swivel yoke take care not to ca
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