Nitronox Field Unit User Manual
Contents
1. 2 3 Operation To operate Nitronox refer to Figure 7 and 1 Unzip the case top and uncoil the oxygen inlet hose 1 from the case Connect the external regulated oxygen supply 2 to the DISS oxygen fitting on the oxygen inlet hose Set the oxygen supply pressure to 45 60 PSI preferably within 50 55 PSI Remove the mixture gas supply hose w demand valve 3 from the case and connect it to the male portion of the quick disconnect fitting 4 on top of the mixer Turn on the oxygen supply 2 and open the nitrous oxide cylinder by turning the valve knob 5 counterclockwise Observe the mixture pressure gauge 6 Normal is 30 35 PSI green band for static no flow condition The pressure will decrease slightly during each breathing cycle by the patient Note If the mixture pressure drops below 30 PSI and whistle alarm sounds during breathing cycle the nitrous oxide cylinder valve is closed or the cylinder is empty SUPPLY VALVE 8 QUICK DISCONNECT FITTING 4 GAS SUPPLY HOSE 3 NITROUS OXIDE SUPPLY 5 MIXTURE 245c 993000 PRESSURE o96 5000990 GAUGE 0 TM Figure 7 Set Up Operation 5 Attach a face mask 7 or a mouth piece to the supply valve 8 Instruct the patient to hold the face mask lightly on the face covering the nose and mouth or seal lips over the mouth piece as shown in Figure 8 Instruct the patient to breathe normally A Warning Patient must self administer at al2. 5 in the center of the nut clockwise to decrease the pressure and counterclockwise to increase the pressure Set the mixture pressure at the middle of the green band on the mixture pressure gauge 7 8 9 10 11 SUPPLY VALVE 7 CONNECT DEMAND TIE 1 MIXTURE PRESSURE CAP WITH REGULATOR 3 WHISTLE ASSEMBLY Figure 15 Mixture Pressure Adjustment Cup seal mouth on hand and hand on demand valve Blow into the small test holes 6 on the back of the supply valve 7 to cause flow through the valve Make sure the mixture pressure remains in the green band Hold the adjustment screw 5 in position with the screwdriver and tighten the nut 4 with the wrench Turn off and disconnect the gas supplies Reinstall the cap with whistle assembly 2 and cable tie 1 over the regulator 3 Secure the cage to the mixer with the screws Reinstall the end caps Follow Section 2 1 Preparation for Use Section 3 Service Field repair is limited to the maintenance and adjustments described in this manual Refer all other repairs to Porter Instrument Division or Authorized Distributor 3 1 Cleaning Keep the Nitronox mixer clean by wiping it after each use with a damp cloth A Caution Do not submerge the mixer A Caution Do not autoclave any Nitronox components 3 2 Inspection and Calibration Porter recommends that you inspect your Nitronox unit regularly by performing the Section 2 2 functional tes
3. oxygen 1 3 Ambient Temperature Limits Normal Operation 40 F 5 C Minimum 100 F 38 C Maximum Operation Below 40 F Start with a warm Nitronox Field Unit stored at 60 F or higher Move Unit into the cold ambient area and begin mission immediately Nitrous Oxide delivery becomes lower with colder temperatures becomes oxygen enriched and also lower over the mission time Description 1 4 Safety Features Several automatic safety features allow the medical professional to attend to patient injuries while the Nitronox is in use 1 4 1 Oxygen Fail Safe If the oxygen line pressure drops or becomes disconnected the nitrous oxide flow and the mixture supply demand valve flow stop automatically If the nitrous oxide supply runs out or is shut off the supply valve continues to provide 100 oxygen at a reduced peak flow of about 40 LPM 1 4 2 Oxygen Enrichment If the patient takes abnormal shallow breaths 100 to 200 mL tidal volume oxygen concentration automatically increases Also increases in colder ambient temperatures see 1 3 Ambient Temperature Limits 1 4 3 Mixer Pressure Alarm If the nitrous oxide supply runs out or is shut off the whistle alarm sounds during breathing cycles and the supply valve continues to provide 100 oxygen at a reduced peak flow of about 40 LPM The whistle alarm also sounds when the mixture concentration changes due to a gas mixture regulator seat malfunction S
4. NITRONOX USER S MANUAL Nitronox Field Unit Analgesia System Parker Hannifin Corporation Porter Instrument Division 245 Township Line Rd Porter Hatfield PA 19440 USA 215 723 4000 fax 218 723 5106 www porterinstrument com nitronox REF 10223000 Rev H Safety Summary A Warnings and Precautions Warning The Nitronox Inhalation Analgesia apparatus is a specialized medical device designed to be operated as indicated herein Only personnel trained in its use should operate it Carefully read this manual prior to operation and use Warning The unit should be operated in an upright position If the nitrous oxide cylinder is in a valve down position while the valve is open liquid may be expelled through the vent passages This liquid nitrous oxide can cause burn by freezing on exposed skin SELF ADMINISTRATION VS ASSIST TO SELF ADMINISTRATION Warning Patient must self administer Encourage patient to fully self administer Self administration is a safety feature of the demand flow Nitronox 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
5. System S curity sag annetd keda atnto lend 2 6 Mixture Pressure AdjUStment l lllllu kk kk kk kk kk kk kk kA Ak KA Section3 SENCO ee E E dead Sul Se lale verveend da AAR 3 2 Inspection and Calibration x xilik nalan kan n M kay l ki Kulika a aasa hek 3 3 Cylinder Filling Specifications nana enne enenne nn enenenneerenneen enne ennnenenneenenenenn 3 4 Troublesho ting mm inerte egeven else ad dn degene nk wek en ne Section 4 Replacement PartS annae Eka kk k kk k kak kk KEKE KAKA KE KA KAKA KAK Section 5 Warr ntiy est assenaar Dvd eds terenta kn ented envi List of Illustrations Figure 1 Nitronox Field Unit Analgesia System nnen iii Figure 2 Removing Mixer from Case nnee kk kk keke kk kek kek kek KAK KAK KAKA Figure 3 Nitrous Oxide Cylinder and Mixer unne ereen enenenenneerenneereneenennenennenen Figure 4 Attaching the Cylinder nnen enen enneenenneerenneenenenenneeneneeneneenensenennenen Figure 5 Reinstalling Assembly in the Cas unnnnn enne erennennnenenneereneeneneennnsenennenen Figure 6 Demand Supply Valve nnnnnnenne eneen kk kake kake k kek KAKA KAKA KAK KAKA KARA Figure 7 Set Up Operation L uu Ek kk kek kk kk kek kek KAKA KARA KAKA KARA KAK KAR KAKA Figure 8 Patient Administered nn vennen enne neer enneneerenneneenennenernensenennennenn Figure 9 Valve Knob Fully Closed nanne enn
6. ctive Action Leak around nitrous oxide cylinder Missing or defective O ring Replace with Porter PN A 4358 003 Intermittent whistle Mixture pressure in green band or moves below 30 psi during breathing cycle Depletion of nitrous oxide Replace nitrous oxide cylinder fill cylinder before use Or Continuous whistle Seat leak in oxygen regulator Seat leak in nitrous oxide regulator Mixture pressure in red band Or Discontinue use Return to Porter for Seal leak gas mixture regulator service malfunction Mixture pressure out of green band Mixture pressure out of adjustment See mixture pressure adjustment in Section 2 6 Mixture pressure in red band but no gas supply hooked up Defective mixture pressure gauge Replace mixture pressure gauge Porter PN A 4358 004 No mixture pressure Unit does not operate No oxygen supply Check oxygen supply The following replacement parts may be obtained from Porter Section 4 Replacement Parts Item Part Item Part No Description Number No Description Number Screw Phillips Pan Head 6 32 x e 1 Wn wir ei a en me E A 4358 004 11 3 8 Lg for Mixer Support Tube Le Pkg 2 Sect 2 6 218 Factory Demand Supply Valve Hose 2 Standoff 1 8 NPT x 1 3 8 Lg Replaced 12 Assembly Fig 7 9112 0523 Table Coupling Insert with Shut Factory 3 Off Replaced 13 Demand Supply Va
7. d by Porter The user has the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alterations by anyone other than Porter Delivery Checkout Examine the shipping carton for signs of external damage Remove the contents from the carton and inspect for visible damage or missing parts If any damage is discovered or suspected and or parts are missing notify Porter or authorized distributor immediately Note Cylinders from Porter are shipped EMPTY Warning Nitronox Analgesia units are intended to be used by medical personnel trained in its use and the use of nitrous oxide and oxygen for medical applications Nitronox Field Unit Inhalation Analgesia Machine Serial Number Table of Contents Safety Summary Warnings and Precautions Self Administration nnee ennen eneen i Section 1 Descriptio iaiia iea ta verdi S e a a i 1A Capacities ini nai nn ee aes 1 2 Mixture Setting DD rJ aaia aaaea diada 1 3 Ambient Temperature Limits aaneen ee neeneneeneenen oneens ennvenenenneenenn 1 4 Safety Features sum nala dudl y lay a N ea dL b e Ld ieee S ction 2 Operation DD esis ena a eee aten i wedi amdresder 2 1 Preparation for USec annaa aN NA N R Naia 2 2 Functional Tests uaaa ede eene ae eneen 29 Operation tnt tenten tate oie ak 2 4 Nitrous Oxide Cylinder Replacement urnrnnannvnnnnvvnnnrrnnnnrnnnnnvnnnrrennnrrrnnnnnnrnnennn 2 5
8. d on demand valve Blow into the small test holes Figure 6 on the back of the demand valve Ensure that the valve energizes by hearing the high flow exit from the valve Figure 6 Supply Valve 7 Close the nitrous oxide cylinder valve and cup hand blow into the small test holes Figure 6 on the back of the supply valve Ensure that the valve energizes by hearing the high flow exit from the valve As the nitrous supply depletes the pressure in the hose the whistle will sound with each test Shut off the oxygen supply and blow cup hand into the small test holes in the back of the valve Figure 6 once more Verify that the mixture pressure drops to zero and that flow through the valve stops 9 Disconnect the gas supply delivery hose at the outlet on top of the mixer It is now ready for storage A Warning Always operate in an upright position 30 from vertical The nitrous oxide cylinder outlet should always be elevated above the base particularly for cold temperature operation A Warning Patient must self administer at all times A Warning DO NOT USE when the mixture pressure is out of the green band If the mixture pressure drops below the green band 30 PSI during a breathing cycle the whistle alarm sounds indicating that the nitrous oxide supply is depleted or shut off Administration of 100 oxygen with this condition is acceptable Caution Always turn on cylinder valves slowly and fully
9. ection 2 Operation The Nitronox Field Unit system is a ready to use unit and needs only an external supply of oxygen Note Cylinders from Porter are shipped EMPTY 2 1 Preparation for Use Make sure that the nitrous oxide cylinder is replaced after each use One full N2O cylinder contains about a 30 minute supply long enough for most single missions 1 Remove the nitrous oxide cylinder and mixer assembly from the shipping cartons 2 Remove the mixer assembly from the carrying case as shown in Figure 2 Remove small red caps Figure 2 Removing Mixer from Case 3 Remove the cap from the outlet of a fresh cylinder of nitrous oxide Inspect the female connector on the mixer to assure that the O ring is in place as shown in CYLINDER HANDWHEEL VALVE O RING Figure 3 Nitrous Oxide Cylinder and Mixer Figure 3 4 Attach the nitrous oxide cylinder to the mixer assembly by turning the hand wheel clockwise until it is hand tight as shown in Figure 4 MIXTURE PRESSURE AUGE VENT _ PASSAGE Figure 4 Attaching the Cylinder 5 Check the connection by opening the cylinder valve slightly and listening for leakage If a hissing noise is heard close the valve and remove the cylinder Recheck to ensure that the O ring shown in Figure 3 is present and in good condition Re assemble and check the connection again to be sure that there is no leakage or hissing noise 6 If the connection is not
10. ecurity Always store the Nitronox unit in a secure area and use the double zipper feature to lock the case as shown in Figure 14 Alternatively lock up demand supply valve assembly FOR SECURITY INSERT PADLOCK THROUGH ZIPPER TONGUES Figure 14 System Security 2 6 Mixture Pressure Adjustment Mixing assembly will be removed from carrying case and both gases will be connected and turned on for this adjustment A Warning When adjusting the mixture pressure ensure that the unit is upright If the cylinder is not upright while the valve is open liquid nitrous oxide can escape through the vent passages and will cause burns by freezing on exposed skin To adjust the mixture pressure refer to Figure 15 and 1 Follow Section 2 4 close cylinder valve Fig 9 remove mixer assembly from case Fig 10 separate cylinder Fig 11 Fig 15 Carefully remove the two red end caps not shown on the mixer assembly Remove the screws not shown that hold the perforated metal cage not shown to the mixer Keeping tie and cap together slide off the cable tie 1 and cap with whistle assembly 2 from the mixture pressure regulator 3 to expose the mixture pressure adjustment nut 4 and screw 5 Attach cylinder Section 2 1 Fig 4 Turn on the unit as described in Section 2 2 Use a wrench to loosen the 7 16 in hex nut 4 approximately turn counterclockwise With a screwdriver turn the adjustment screw
11. enenneerenneenenenenneereneeeneneennnnenennenen Figure 10 Removal from Carrying Case ennnenenneereneennenenneerenern enne KA KAR KAYA Figure 11 Separating the Cylinder nnee nnen ennnenenneerenneennnenenneerenernenenennnenennenen Figure 12 O Ring Placement enenneneenneeneneneneereneeneneeennserenernennennnnenenneenenenenn Figure 13 Reinstalling Assembly in Case unnnenennenrenennenenenneerenneeneneennnnenennenen Figure 14 System Security EEELE EEE kk kk kk kk kk kk kek KE KA KAKA KARA KARA KAK KAK KK AKA KA KA Figure 15 Mixture Pressure Adjustment neen kk kk kk E kA KAKA KA KA AR Figure 16 Exploded Parts Illustration nennen kk kk kek AA KA Figure 1 Nitronox Field Unit Analgesia System Section 1 The Nitronox Field Unit shown in Figure 1 is a portable inhalation analgesia system designed to deliver a 50 oxygen 50 nitrous oxide analgesic gas mixture to a patient via patient held demand supply valve and face mask or a disposable mouthpiece It includes a single mission supply of nitrous oxide and utilizes an external supply of oxygen 1 1 Capacities The Nitronox system is capable of delivering peak flows of up to 100 liters per minute at normal breathing rates for approximately 30 minutes with one cylinder of nitrous oxide 14 ounces and a continuous high pressure O supply 1 2 Mixture Setting Mixture concentration is factory set at 50 nitrous oxide and 50 oxygen 5 percentage points
12. fin 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 Instrument 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 REF 10223000 Rev H 03 13
13. he mixer to assure that the O ring Figure 12 is in place Attach the cylinder to the mixer assembly by turning the hand wheel clockwise until hand tight 6 Check the connection by opening the valve slightly and listening for leakage If hissing is heard close the valve and remove the cylinder as described in step 4 Recheck to ensure that the O ring shown in Figure 12 is present and in good condition Reassemble and check the connection once more to make sure there is no leak If the connection is not leaking close the valve Do not store the unit with the valve open Figure 10 Removal from Carrying Case 3 Hold the assembly in the upright position and slowly unscrew the large hand wheel by turning it counterclockwise as shown in Figure 11 O RING FITS IN THIS GROOVE VENT PASSAGE OF OAO OG 0009090 OA ol Figure 12 O Ring EERE 7 Reinstall the mixer cylinder assembly in its case as shown in Figure 13 Make sure the mixture pressure gauge is visible The apparatus is now ready to use Figure 11 Separating the Cylinder A Warning If a hissing sound is heard stop and recheck that the cylinder valve is closed and that the oxygen supply is off A Warning If the cylinder is not in an upright position when the valve is open liquid nitrous oxide can flow through the vent passages and cause freeze burns by freezing exposed skin Figure 13 Reinstalling Assembly in Case 2 5 System S
14. im 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 Parker 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 Hanni
15. l times 6 After use turn off all cylinder valves and disconnect the oxygen supply Clean the valve Dispose of the mask or mouthpiece Prepare the apparatus for the next use Figure 8 Patient Administered A Caution When the unit is not in use ensure that the nitrous oxide cylinder is off and that the oxygen supply is disconnected or off A Caution The mixer bleeds off oxygen at a constant rate of 125 mL per minute when the oxygen supply is connected and turned on This bleed over time can deplete the oxygen supply A Caution Make sure the nitrous oxide cylinder is replaced after each use One cylinder contains approximately a 30 minute supply which is long enough for most single missions 2 4 Nitrous Oxide Cylinder Replacement Make sure the nitrous oxide cylinder valve is in a fully closed position by turning the valve knob Figure 9 clockwise until it stops Ensure that the oxygen supply to the unit is off and disconnected Figure 9 Valve Knob Fully Closed 2 Remove the mixer assembly from the carrying case as 4 Continue by removing the cylinder and valve shown in Figure 10 assembly Tag the cylinder to show it is no longer full Return the cylinder to a secure storage area A Caution Full cylinders have a cap on the outlet Always assume that a cylinder without this cap is no longer full 5 Remove the cap from the outlet of a fresh cylinder of nitrous oxide Inspect the female connector on t
16. leaking close the valve DO NOT store the unit with the cylinder valve open Warning If the cylinder is not in an upright position when the valve is open liquid nitrous oxide can flow through the vent passages and cause burns by freezing exposed skin 7 Install the cylinder mixer assembly in its case as shown in Figure 5 Make sure that the mixture pressure gauge is visible The apparatus is now ready for use Figure 5 Reinstalling Assembly in the Case 2 2 Functional Tests Prior to first using the Nitronox unit and once a week thereafter perform the following tests 1 Connect the nitrous oxide cylinder to the mixer per procedure in 2 1 Uncoil the oxygen supply hose from the case Remove the gas supply delivery hose from the case and connect to the male portion of the quick disconnect fitting on top of the mixer Connect the oxygen hose to a 50 55 PSI oxygen supply Turn on the oxygen supply and verify that mixture pressure shown on the mixer pressure gauge is 30 35 PSI within the green band Adjust per Section 2 6 Turn on the nitrous oxide cylinder by turning the cylinder valve knob counterclockwise Verify that there is no leakage at the connections or relief valve by listening or by applying a soap solution around the various fittings If the whistle alarm sounds continuously immediately discontinue use and shut off gas supply Contact Porter for repair Cup seal mouth on hand and han
17. lve Fig 7 9112 0028 7 Factory A 4 Nipple 1 8 NPT x 1 1 2 Lg Replaced 14 Users Manual 1022 3000 DISS Oxygen Inlet Hose Assembly i j 5 w Instructions FM 1244 A 4358 005 15 Users Placard 6491 6100 6 Cable Tie Pkg 3 Fig 15 A 4358 000 16 Caplug Bottom Sect 2 6 6290 5526 7 hae Mees Onee 2013 2502 17 Caplug Top Sect 2 6 2010 8700 Nitrous Oxide Cylinder 1 New C 1703 8 Alarm Cap Fig 15 1018 3000 18 Empty Fig 7 000 O ring for Hand Tight Nut Pkg 3 A 4358 9 Mixer Support Tube Sect 2 6 3011 3800 19 Fig 12 003 10 Soft Case w Strap 6491 5800 Not Illustrated Figure 16 Exploded Parts Illustration CERTIFICATE OF WARRANTY THIS WARRANTY IS GIVEN IN PLAGE 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 cla
18. 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 Warning DO NOT USE if the mixture pressure is out of the green band If the mixture pressure drops below the green band 30 PSI during a breathing cycle and the whistle alarm sounds the nitrous oxide supply is depleted or shut off When this happens the unit will administer 100 oxygen It is acceptable to administer oxygen in this manner Warning If the whistle alarm sounds continuously immediately discontinue use and shut off the gas supply Contact Porter Instrument Division or Authorized Distributor for repair Caution Always turn on cylinder valves slowly and fully Caution Disconnect the oxygen supply and close the nitrous oxide valve when the unit is not in operation Never store the unit with the nitrous oxide valve open User Responsibility The Nitronox Inhalation Analgesia apparatus is designed to perform to specifications when operated and maintained as instructed herein Replace defective or worn parts immediately Do not use a defective product Do not repair this product other than in accordance with the written instructions provide
19. ts Every 2 years Porter also recommends that the unit calibration be factory certified 3 3 Cylinder Filling Specifications The following notes are for use by nitrous oxide vendors in conjunction with their standard safety and nitrous oxide refilling procedures The customer may photocopy these specifications and supply the refilling vendor Cylinder must be evacuated by vendor before refilling Cylinders were originally cleaned for oxygen use per spec RR C 9016 paragraph 3 8 2 Inspect and reclean if necessary e Valve torque 75 foot pounds e The valve outlet is to be covered with a vendor supplied caplug e The paint on the neck of the cylinder is nitrous oxide blue spats paint 2162 e The body of the cylinder is clear coated with DUPONT IMRON 500S to indicate exposure to elevated temperature Do not refill if the cylinder is discolored e Fill with 14 oz of nitrous oxide U S P e Certify for human consumption Maintain certificate of analysis per lot and lot commodity code number e Re label as necessary Vendor is to supply product safety sheet mark labels with lot number contents expiration date and cylinder size e Customer returned empty cylinders to be accepted and refilled only if they are in good condition 3 4 Troubleshooting There are several indications when problems occur in the Nitronox Use the table below as a guide when there appears to be a problem Indications Possible Cause Corre
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