HANS RUDOLPH, inc. SERVICE AND INSTRUCTION MANUAL Rudolph Pneumotachometers (PNT) and Heater Controllers

MAKERS OF RESPIRATORY VALVES SINCE 198 HANS RUDOLPH, inc. www.rudolphkc.com TEL: (91) 4-7788 U.S.A. & CANADA (800) 456-6695 FAX: (91) 4-7 E-Mail: hri@rudolphkc.com 85 COLE PARKWAY, SHAWNEE, KANSAS 667 U.S.A. Page 1 SERVICE AND INSTRUCTION MANUAL Rudolph Pneumotachometers (PNT) and Heater Controllers For additional information refer to Data Sheet 697 Rudolph Linear Pneumotachs & Data Sheet 6919 OEM Applications Linear Pneumotachs (PNT) & Heater Control Printed Circuit Boards (PCB). PAGE TABLE OF CONTENTS... 1 1.0 CUSTOMER SERVICE AVAILABLE... 1.1 User Assistance Information... 1. Loaner Program... 1. Cleaning & Care... 1.4 Labeling (Serial Numbers)... 1.5 General Warnings and Cautions... 1.6 Inspection and Usage....0 GENERAL DESCRIPTION....0 THEORY OF OPERATION/PURPOSE OF DEVICE....1 General Information.... Design Criteria.... Principle of Operation....4 Calibration....5 Installation Requirements....6 Turndown Ratio....7 Linearity....8 Performance....9 Sizing Selection.... Secondary Instrumentation....11 Viscosity & Temperature....1 Gas Density... 4.0 PNEUMOTACH SELECTION SPECIFICATIONS... 5.0 CROSS SECTIONAL VIEWS OF HEATED PNEUMOTACHS... 6.0 EXPLODED ASSEMBLY DRAWINGS, REPAIR AND REPLACEMENT PARTS... 6.1 Figures 1 through 5 Complete PNT Series... 6. Pneumotach Repair and Replacement Parts... 6. Tabulation for Exploded Assembly Drawings... 7.0 FRONT VIEW OF HEATER CONTROL (TWO PNT ADAPTABLE TYPE)... (FIG.A) 7.1 Fig. A Descriptions... 8.0 REAR VIEW OF HEATER CONTROL (TWO PNT ADAPTABLE TYPE)... (FIG. B) 8.1 Fig. B Descriptions... 9.0 OPERATING INSTRUCTIONS... 9.1 Non-Heated Pneumotach... 9. Heated Pneumotach & Heater Controller... 9. Electronic Features of the Heater Controller... 9.4 Electrical Schematic/Specifications for PNT Heater Control....0 MAINTENANCE....1 Non-Heated Pneumotach/Heated Pneumotach & Heater Controller....1A Disassembly of the PNT....1B Inspection of the PNT Components....1C Manual Cleaning of the PNT Components....1D High Level Disinfection with Liquid Chemical Glutaraldehyde....1E Reassembly of PNT....1F Verifying Heater Shell & Heater Controller.... Cleaning PNT Heater Control... 11.0 TYPICAL GRAPH (AS SUPPLIED WITH PURCHASE) OF THE LINEAR... SIGNAL PRESSURE AND BACK PRESSURE. 81/481 (0-800 L/min) SERIES 1.0 REFERENCE LITERATURE (Pneumotach Applications)... 18,19 698-1 014-05-05 Rev. O Prices & Specifications subject to change without notice 4 4 4 4 4 4 5 5 5 5 6 7 8 8 9 9 11 11 1 1 1 1 14 15 15 15 15 15 15 16 16 16 17

Page 1.0 CUSTOMER SERVICE AVAILABLE 1.1 User Assistance Information Refer to our POLICY sheets for information and the procedure for obtaining Warranty and Non-Warranty Service. If you do not have a copy of the applicable policy, request one of the following. 1. Retail Ordering Policy, Domestic & International 690. Domestic O.E.M. /Dealer Policy 6901. International O.E.M./Dealer Policy 69011 Additional Hans Rudolph, inc. assistance is available from 8:00 a.m. - 4:0 p.m. Central Standard Time (C.S.T.) U.S.A., Monday through Friday. Call toll-free in U.S.A. & Canada (800) 456-6695, Phone (91) 4-7788, Fax (91) 4-7 or E-Mail: hri@rudolphkc.com 1. Rental Program Rental Products are available at a charge to the customer plus shipping costs, both ways. This program is for customers who require to keep their systems up and running and cannot be out of operation during normal repair or recalibration of a Rudolph product. Contact Hans Rudolph, inc. for a Return Authorization Number (RAN) to enclose with the returned item. A purchase order number is required from the customer for HRI to ship a rental. 1. Cleaning & Disinfection Brochure 691199 should be in your possession and completely comprehended before proceeding with cleaning of Rudolph Products. Refer to section.0 Maintenance, Page 15 of this Service & Instruction Manual for cleaning information. 1.4 Labeling The Pneumotach (PNT) Shell, Body & Screens/Spacers are marked with a Serial Number to facilitate correct reassembly after cleaning & care of each PNT and for Lot Traceability. Additional labeling including; PNT Model Series Number, Calibrated Flow Range, Hans Rudolph, inc. company name & location is placed on the non-heated shell, heated shell and on a label attached to the cable assembly. A Hot Surface Label is also placed on the heater shell for all heated PNTs. Supplied with each Pneumotach is an orange, laminated, CAUTION card P/N 691165 (with hole punch & tie wrap) that can be easily mounted on equipment close to the PNT site. This card contains cautionary labeling that has been expanded to alert and help the end user in understanding the PNT and its application. The recalibration due date is noted on the back side of this card. 1.5 General Warnings And Cautions WARNING: To avoid potential electrical hazard, use only a polarized -Wire AC Outlet when plugging in the Heater Controller AC Power Cord. This assures the Controller Chassis and Ground Terminal are connected to a good earth ground and reduces danger from electrical shock. Do Not Use A -Wire Adapter. The controller should always be turned off with the power on-off switch. For 0V 50Hz electrical sources, the controller can be ordered with an International Power Cord with appropriate power plug. WARNING: Connect to hospital grade receptacle only. Possible explosion hazard if used in presence of flammable anesthetics. Electric shock hazard-do Not Remove Cover, refer service to qualified service personnel. Replace fuses with the same type and rating, 50 Volt 1/ Amp. CAUTION: On the heated models, the external surface of the PNT is hot, ranging from 5 C to 45 C depending on the control setting. Do Not allow this instrument to contact the patient. Particular care should be taken in neonatal applications where the PNT is mounted close to the patient. Thermal protection is incorporated to shut off the heater permanently if a heater malfunction occurs. CAUTION: Do not mix & match pneumotach components between different pneumotachs. Every PNT Adapter, Screen, Spacer, Body & Shell should be kept together & reassembled as was received originally. The shell (heated & non-heated), body & screens/spacers are all serialized to assure correct reassembly. See section 6.0 Exploded Assembly Drawings, Repair & Replacement parts, Page 8 for location of this marking. CAUTION! READ BEFORE USING PNEUMOTACH! Screen PNTs will not function properly if used in humidified circuits where moisture can collect on the screens and occlude them. Heated models should be evaluated in these situations through visual inspection of the screens after the PNT has been used in the circuit for the desired amount of time. Do not use in a humidified ventilator circuit for long term continuous flow monitoring. Never leave PNT in the ventilator circuit unattended by qualified personnel. USA Federal Law restricts this device to be sold by or on the order of a physician. Do Not disassemble this product without following the Pneumotach Service and Instruction Manual 698, and PNT Cleaning and Disinfection Brochure 691199. This product is individually polyethylene bagged and shipped clean, non-sterile. CAUTION: Do not use tools (other than supplied by Hans Rudolph) or force during disassembly or assembly. CAUTION: Do not submerge heater shell (G) or heater controller in water, detergent, or any other liquid. CAUTION: Do not autoclave. 698-014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 1.6 Inspection And Usage A visual inspection of the mating tapers should be made to verify a good clean surface free of nicks or scratches, which would allow a wrung grip to disconnect prematurely. There should be no perceptible rocking in any direction when the components are wrung together. If accidental disconnection is a safety or critical concern, the user should attach an elastic band or other device to prevent separations of the connection components..0 GENERAL DESCRIPTION The Hans Rudolph, inc. Pneumotachs (PNT) have been specifically designed, patented and manufactured for human and animal physiological respiratory studies and testing. The linear and bi-directional patented Rudolph Pneumotach is available in a wide range of sizes from 0- L/min to 0-800 L/min calibrated flow ranges. The pneumotachs are available as heated and non-heated. The Series 850 Heater Control is designed to control the temperature of the screen assemblies, allowing a temperature variance of C to 4 C. Heater Controls are available as one or two pneumotach adaptable, and are 115V 60Hz or 0V 50Hz Switch Selectable..0 THEORY OF OPERATION/PURPOSE OF THE DEVICE.1 General Information Pneumotachometers are air flow sensors which convert air flow into proportional differential pressure. To transmit this proportional differential signal pressure to one of many recording devices (computer, strip chart recorder, oscilloscope, X-Y recorder) an output voltage proportional to the applied pressure must be provided. This is done by connecting a differential pressure transducer to the signal pressure taps of the pneumotach. The pressure transducer converts the differential pressure supplied by the pneumotachometer into an analog electrical value. For this purpose, the transducer must be connected to a measuring bridge or bridge amplifier. Typically the dynamic response of the system is largely affected by the pressure transducer and associated tubing and fittings. Each Rudolph Pneumotach, supplied with a graph showing the signal pressure & back pressure values at incremental flow rates throughout its range is ready to measure flow when connected to a differential pressure transducer and amplifier recording system. The patented Rudolph Linear Pneumotachometer uses a special screen design to convey flow of gases in either direction into a proportional signal of pressure difference at opposite sides of the center screen. The design results in linearity over the complete model series flow range. Sizes are available for specific use in the areas of premature infants, neonates and small animals such as mice, rats & guinea pigs through adults and large animals. Primarily used for pulmonary function testing, stress/exercise testing, respiratory care, metabolic measurements and physiological human/animal research.. Design Criteria All sizes of pneumotachs are designed to have minimum volume dead space and to be linear and bi-directional over entire designated flow range. In applications where humidity & moisture are a concern, leaving water vapor condensation on the screens of the pneumotach, the heated pneumotach and heater control are recommended. If water vapor condensation is not a possibility, the non-heated pneumotach is available. The complete range of pneumotachs are available as heated & non-heated. The heated pneumotach can be used without the heater shell and heater control unit. Likewise, the non-heated pneumotach may be converted to a heated unit by replacing the non-heated shell with a heater shell assembly and heater control unit. Series 840/841, 840/841, 84/8411, 800/811 & 719/4719 pneumotachs have only one screen, with spacers replacing the other two screens, unlike the Series 500/4500, 700/4700, 80/480 and 81/481 pneumotachs which are three screen designs, (refer to exploded assembly drawings). 698-014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 4. Principle of Operation The Rudolph Pneumotach (PNT) operates as other differential pressure ( P) flow meters in the equations of flow that it uses. The principal theory may be stated as a mathematical law known as Poiseuille's Law which relates the volume of air flow through a tube to the differential pressure, diameter of the tube, length of the tube and the viscosity of the flowing air. This law is based upon the assumption that the air flow in the tube is laminar. Flows with a Reynold's number less than 000 are considered laminar. The Reynold's number is a dimensionless parameter of the air flow that is used to determine if the flow is laminar or turbulent. In laminar flow, the P is linearly related to the air flow volume of the flowing air, whereas for turbulent flow the differential pressure ( P) is related to the square of the air flow volume of the flowing air. In the typical respiratory flow circuit the air flow is turbulent with Reynolds number >000. Installing a Rudolph PNT into the flow circuit will create laminar flow because the design provides many passageways in the fine mesh screen, each of which has a uniform hydraulic diameter. The degree to which this mesh screen distributes the flow profile is a function of the Reynolds number based on screen wire diameter and mesh opening hole size. The Rudolph PNT geometry has many advantages over other screen type pneumotachs. The higher flow PNTs i.e. 0-800, 0-400, 0-160 and 0-5 L/min incorporate a three screen design where the differential sensing points are on either side of the middle screen assembly. In turbulent flow the axial flow profile is irregular, whereas, in laminar flow the profile is well developed with a parabolic velocity distribution. As the irregular turbulent flow approaches the three screen assembly of the PNT the outer screen disturbs the flow profile creating more even distribution of flow. This improves linearity by controlling the flow profile at the entrance to the middle screen where the P is measured..4 Calibration Each PNT is calibrated in both flow directions without a heater at static flow rates throughout it's full range. Calibration is performed in series with laminar flow elements that are linearized and traceable to NIST. A compressed air flow system is used with flowing air temperature maintained at 1 C, humidity less than 0% RH, the Calibration Data is provided with each PNT. Hans Rudolph, inc. recommends that each PNT should be calibrated in the field to verify the performance in a flow circuit different from the original calibration. If possible, use a calibration gas which simulates the composition, temperature and humidity of the gas to be measured..5 Installation Requirements The recommended installation is five diameters (ID) of straight bore tube upstream of the PNT. If the PNT is used bidirectionally then follow this recommendation for both up and down stream diameters. Eliminate flow disturbances wherever possible such as elbows, reductions or expansions close to the PNT. Attach mating tubing or connectors to the outside diameter of the PNT ports not to the inside diameter. Always verify calibration of the PNT over the entire range of flows in the circuit installation..6 Turndown Ratio Typical turndown ratio for Rudolph PNTs is to 1. This is the range that each PNT is calibrated. For example the 0-800 L/min PNT is calibrated from 80-800 L/min in % increments. Lower flows are measurable and repeatable by applying a curve fit to the measured P..7 Linearity Linearity is better than ± % of reading of Best Straight Line (BSL). This specification is the PNT differential pressure ( P) signal measured on the calibration flow bench at static flow rates with a high accuracy ±.08% of reading P transducer..8 Performance The Rudolph PNT is manufactured of quality materials to offer long term performance. All PNTs can be disassembled in seconds for inspection, cleaning and part replacement. The screen assemblies are a precision subassembly consisting of oxide plated brass rings and a stainless steel screen that is optically aligned and serialized for maximum consistency. 698-4 014-05-05 Rev. O Prices & Specifications subject to change without notice

.9 Sizing Selection Selection of the appropriate PNT is based on the following specification parameters: The following table lists PNT series with size selections as a guide to help specify the correct PNT for your application. SERIES APPLICATION FLOW RANGE (L/min.) DEAD SPACE VOLUME(ml) 840/841 MOUSE 0-.-.4 840/841 GUINEA PIG 0-5.6-.7 1 84/8411 PREMATURE 0-1.1-1. 800/811 NEONATE 0-1.6-5 500/4500 INFANT 0-5 6.8-11.5 719/4719 PEDIATRICS 0-0 18 700/4700 PEDIATRICS 0-160 14 80/480 ADULTS 0-400 51-58 81/481 ADULTS 0-800 88 Page 5 1 Less Than 8 Week Gestational Birth to One Month 1-1 Months Full Scale Flow Rate Specify a PNT that will be used in its calibrated flow range. Dead Space Volume Total volume inside the PNT. In some applications this is a critical parameter. Signal Pressure Differential Pressure ( P) output that is a function of the flow rate. A Differential Pressure ( P) Transducer is required that is rated for this pressure range. Tube connections between transducer and PNT should be leak free, non-compliant and minimum length. Back Pressure Pressure drop across the entire PNT. This is measured at each calibration flow rate. Tube Adapter Diameters Ports on the PNT which thread into the main housing are either straight diameters or medical tapers.. Secondary Instrumentation A Differential Pressure Transducer is required to measure the differential pressure signal from the PNT. Full scale pressure range of the transducer should be closely matched with the full scale P signal of the PNT. Two pressure taps are provided on the PNT for.15"(.mm) ID tubing that will mate with a P transducer. Tubing should be noncompliant at these pressures, short as possible and equal length. Connected to the P transducer is a carrier demodulator circuit used to provide transducer excitation and to amplify and demodulate the output from the transducer. Typical output is linear analog ± VDC to ± VDC. These voltage signals from the carrier demodulator are fed into an A/D card in a PC (Personal Computer) converting analog into digital information which interfaces with the pulmonary analysis software. The PC software samples the incoming flow signal and continuously integrates, calculating total volume..11 Viscosity & Temperature Poiseuille's Law states that the pressure developed in laminar air flow conditions is directly proportional to the gas viscosity. Gases show an increase in absolute viscosity with an increase in gas temperature. The differential pressure for a given volume of air flow will increase as stated by Poiseuille's Law as the viscosity of the flowing air increases. The viscosity of a gas mixture can be calculated by weighted averages of the viscosities of the gases composing the mixture. For the types of gases found in respiratory circuits over the temperature range 0-40 C the fractional change in viscosity of the mixture as a function of temperature is in the range of.005/ C. The fractional change in the volume with temperature at constant pressure is.004/ C. When there is a temperature difference between the heated PNT and the flowing gas the correction factor will depend on the flow rate. If the PNT heats the gas it will increase the viscosity and volume of the gas at that instant. The temperature rise will depend on the time the gas is in contact with the screens. This time will vary with the flow rate. An estimation of this correction is very difficult. Temperature and gas composition would have to be monitored continuously at the PNT with corrections made to the instantaneous flow rates. Corrections can be made by calibrating with the test gas..1 Gas Density Gas density is not a factor in Poiseuille's Law so it will not have an affect on the P of the PNT, but it is a factor in the Reynold's number calculation and will affect the maximum flow rate for which the PNT response is linear. 698-5 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 6 4.0 PNEUMOTACH SELECTION SPECIFICATIONS: MODEL SERIES HEATED NON-HEATED 840A 841A Calibrated Flow Range L/min (L/sec) 0-L/min (0-.05 L/sec) Dead Space Volume ml.9ml SignalPressure (DiferentialPressure Inputto Transducer ( )mm HO(dp) atmax flow ( )L/min mm HO(dp) at L/min max flow Flow Signal Calibration Factor ( )mm HO L/min.mm HO L/min Back Pressure (Resistance to Flow) ( )cmho ( )L/min Low Flow.cm HO/L/min Mid Flow 1.4cmHO/1.5L/min High Flow 4.0cmHO/L/min Flow Bore Diameters Flange ID-in(mm) Screen Set ID-in(mm).09 in(.4mm).155in(.9mm) Application Recommendations Mouse 840B 841B 0- (0-.05).0../. 1.4/1.5 4.0/.09 (.4).155(.9) Mouse 840A 841A 0-5 (0-.08).71 8 5 1.60.1/.5.7/.5 1.6/5.148 (.8).6(6.0) Mouse,Rat, Guinea Pig 840B 841B 0-5 (0-.08).59 8 5 1.60.1/.5.7/.5 1.6/5.148 (.8).6(6.0) Mouse,Rat, Guinea Pig 84A 8411A 0- (0-.166) 1.0 1.00.1/1.8/5.0/.187 (4.8).90(7.4) 1 Premature, Feline 84B 8411B 0- (0-.166) 1.06 1.00.1/1.8/5.0/.187 (4.8).90(7.4) 1 Premature, Feline 800A 811A 0- (0-.166) 1.66 7.70.05/1.4/5.9/.50 (6.4).55(9.0) Neonate, Rabbit 800B 811B 0- (0-.166) 5.06 7.70.05/1.4/5.9/.50 (6.4).55(9.0) Neonate, Rabbit 800C 811C 0- (0-.166).65 7.70.05/1.4/5.9/.50 (6.4).55(9.0) Neonate, Rabbit 800D 811D 0- (0-.166).8 7.70.05/1.4/5.9/.50 (6.4).55(9.0) Neonate, Rabbit 500A 4500A 0-5 (0-.58) 6.81 7 5.0.1/.5.95/17.5.7/5.75 (9.5).65(15.9) Infant, SmalCanine 500B 4500B 0-5 (0-.58) 8.74 7 5.0.1/.5.95/17.5.7/5.75 (9.5).65(15.9) Infant, SmalCanine 500C 4500C 0-5 (0-.58) 11.45 7 5.0.1/.5.95/17.5.7/5.75 (9.5).65(15.9) Infant, SmalCanine 719 4719 0-0 (0-1.666) 18.15 0..05/.45/50 1./0.750 (19.1).970(4.6) Pediatrics, Canine 700A 4700A 0-160 (0-.666) 14.18 16 160../16./80 7.0/160.550 (14.0).970(4.6) AdultatRest, Pediatrics, Large Canine 700B 4700B 0-160 (0-.666) 1.87 16 160../16./80 7.0/160.550 (14.0).970(4.6) AdultatRest, Pediatrics, Large Canine 80A 480A 80B 480B 0-400 (0-6.666) 0-400 (0-6.666) 50.9 58.16 15 400 15 400.04.04.5/40.4/00 7.5/400.5/40.4/00 7.5/400.850 (1.6) 1.455(7.0).850 (1.6) 1.455(7.0) Adult(PFT), Pediatric Spirometry Adult(PFT), Pediatric Spirometry 81 481 0-800 (0-1.) 87.80 16 800.0./80.8/400 8./800 1.15 (8.6).00(50.8) Athlete, Spirometry 1 Less Than 8 Week Gestational Birth to One Month 698-6 014-05-05 Rev. O Prices & Specifications subject to change without notice 1-1 Months

5.0 CROSS SECTIONAL VIEWS OF HEATED PNEUMOTACHS Note: Non-Heated PNTs are less the Heater Shell & Cable Assembly. Page 7 Linear & Bi-Directional Gas Flow Series 80A-B, 81 Heated PNT (Shown here) Series 480A-B, 481 Non-Heated PNT Series 700A-B, 500A-C Heated PNT (Shown Here) Series 4700A-B, 4500A-C Non-Heated PNT. Tabulation for Parts Detail (above) A. Port Tube, Small Flange B. Pneumotach Body C. Pressure Tap Assembly (Hose barb for Differential Signal Pressure) D. O-Ring E. Port Tube, Large Flange F. Heater Shell & Cable Assembly with Cable Connector for Heater Control Receptacle G. # Position Spacer/Screen Assembly H. # Position Screen Assembly I. #1 Position Spacer/Screen Assembly J. Screen Set (Flow Calibrated Together) Series 800A-D, 719 Heated PNT (Shown here) Series 811A-D, 4719 Non-Heated PNT A. B. C. D. E. F. G. H. I. J. Linear & Bi-Directional Gas Flow 15mm ID Taper Integral To PNT Body Series 840B, 840B, 84B Heated PNT 841B, 841B, 8411B Non-Heated PNT Series 840A, 840A, 84A Heated PNT Series 841A, 841A, 8411A Non-Heated PNT 698-7 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 8 698-8 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 9 698-9 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page Fig. A 698-014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 11 Fig. B 698-11 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 1 9.0 OPERATING INSTRUCTIONS 9. 1 Non-Heated Pneumotach a) Connect the Port Tubes (Both Large & Small Flange Sides) to the ga flow circuitry. b) Complete the pressure connection between the Differential Pressure Tapson the Pneumotach and the appropriate ports of the Differential Pressure Transducer. The flow will then be detected by pressure changes recorded in the Transducer Amplifier Recording System. The individual calibration record facilitates converting the signal pressure reading of the Pneumotachometer, Transducer & Amplifier System into a Flow Rate recorded in units of Umin. The calibration records are direct reading values of Differential Pressure in millimeters of water gauge relative to the air flow rate. It should be noted that small differences in absolute values may be experienced through the errors inherent in an electronic transducer amplifier system. 9. Heated Pneumotach & Heater Control l er a) Press the On/ Off Li ghted Power S wi tch. Use only a polarized - wire AC outlet. This assures the Heater Control Chassis and Ground Terminal are connected to a good earth ground and reduces danger of electrical shock. Do not use a -wire adapter. The control should always be turned off with the power on/off switch. A hospital grade cord set is provided for 115V 60Hz U.S.A. power requirements and a foreign country specific cord set is provided for 0V 50Hz International requirements. Plug in power cord and switch to on position. Lighted switch indicates power to the controller. b) Check the voltage selector switch on the rear panel. c) Set the PNT S elector S witch to Pneumotach (PNT) Series that is connected to the Heater Control. d) Set the S creen Temperature S etti ng on the Temperature Controller to the maximum temperature measured in the Flow Circuit. e) For Warm-Up wait approximately 5 minutes with Model Series 840, 840, 84, 800, 500,719 & 700 and approximately 15 minutes for Model Series 80 & 81. f) Connect the Port Tubes to the Gas Flow Circuitry. g) Complete the pressure connection between the Differential Pressure Taps on the Pneumotach and the appropriate ports of the Differential Pressure Transducer. The Heating Pilot Light located on the Front Panel of the Heater Controller is illuminated only when the Thermistor Sensor in the Heater Shell senses a temperature lower than that set on the screen temperature setting. This pilot light should come on when the controller is plugged in and the screen temperature setting is set above room temperature. NOTE: During use the pilot light should cycle on and off. CAUTION: If the pilot does not cycle or light up, and the pneumotach still warms up, the controller is defective and should be returned for repair. If the pilot does not light and the pneumotach does not heat, check the fuses. If the fuses are good return the Heater Controller and the Heater Shell/Cable Assembly for repair, only after you have verified that their is voltage at the 1 or 0 Volt AC power outlet. On all returns provide written description of conditions under which the unit failed. Contact Hans Rudolph, inc. for a Return Authorization Number (RAN). NOTE: If there is visible water vapor or condensate in the breathing tubes leading to the Pneumotach, it is suggested that 1 C to C higher than circuit temperature be selected on controller screen temperature setting. This differential should be able to handle the high humidity and avoid condensation on Pneumotach Screens. 698-1 014-05-05 Rev. O Prices & Specifications subject to change without notice

9.0 OPERATING INSTRUCTIONS (CONT.) 9. Heated Pneumotach & Heater Control l er (Cont. ) CAUTION: Screen pneumotachs will not function properly if used in humidified circuits where moisture can collect on the screens and occlude them. Heated models should be evaluated in these situations through visual inspection of the screens after the PNT has be used in the circuit for the desired amount of time. Do not use in a humidified ventilator circuit for long term continuous flow monitoring. 9. Electronic Features of the Heater Controller The Pneumotach Heater Control contains the Automatic Temperature Sensing and Control Circuitry, Panel Mounted Receptacle for the PNT Heater Shell and Cable Assembly 5 Pin Connectors and the AC Line Power Conversion Circuitry. The Automatic Temperature S ensing and Control Circuitry is all solid state, utilizing a State-of-the-Art Thermistor Sensor (Thermal Resistor) to provide feedback to a proportional control circuit. The Thermistor Feedback is in the form of Absolute Resistance, which is converted to a voltage signal that is compared to a voltage signal representative of the desired temperature setting. The result of this comparison commands power to be supplied to the Heating Element within the Heater Shell Assembly, proportional to the deviation between the sensed temperature and the desired temperature setting. As the two temperatures close, the power to the heater is decreased and eventually discontinues when the temperatures are equal. Page 1 A Heating Pilot Light illuminates when power is being applied to the heater. As the heater shell temperature rises to the desired temperature setting, the light diminishes and eventually extinguishes when the temperature becomes equal. The AC Line Power Conversion Circuitry isolates the Automatic Sensing and control circuitry and the Heater and Heater Shell Assembly from the AC line. The Solid State Circuitry and Heater all operate at a safe 1VDC voltage level. The AC line portion is protected by Line Fuses. CAUTION: Because of the presence of the AC Line Voltage, this unit should never be used in an explosive or flammable environment. The Temperature Control provides for adjusti ng the temperature of the screens within the Heater Shell Assembly: Between C and 4 C. Normally a temperature setting between 7 C and 4 C will adequately prevent condensation. When not in use, position the temperature setting to C. This setting is normally well below room temperature and will cause the heater to remain off. If the room temperature falls below C, the control will automatically maintain C to minimize the warm-up time. An on/off switch is on the unit to turn power off when the unit is not in use. The Heater Control is adaptable for foreign 0V 50Hz or U.S.A. 115V 60Hz. Select appropriate part number (P/N) from the ordering information section on Data Sheet 697 Rudolph Linear Pneumotachs or the Linear Pneumotachometers section of the Detailed Price List. If there is a problem please refer to Page Section 1.0 Customer Service Available. 698-1 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 14 ITEMS ON PRINTED CIRCUIT BOARD ITEM PART NO. DESCRIPTION C1 87150 CAPACITOR 00 MFD 5V C, C 871519 CAPACITOR 0.1 MFD 0V D1 - D4 8701 DIODE SI IN4004 HS1, HS 871506 HEAT SINK TO-0 JP1 87090 HEADER STRAIGHT POST PIN Q1, Q4 8705 TRANSISTOR NPN SI TO-9 Q 8705 TRANSISTOR PNP SI TO-9 Q 87054 TRANSISTOR NPN SI TO-0 R1, R 87047 RESISTOR 511 OHM.5W 1% R, R11 8701 RESISTOR 1K OHM.5W 5% R4 870 RESISTOR 680 OHM.5W 5% R5, R9 87044 RESISTOR 1.5K OHM.5W 1% R6 87049 RESISTOR 1.6K OHM.5W 1% R7 87048 RESISTOR 1.69K OHM.5W 1% R8 87050 RESISTOR 7 OHM.5W 1% R 87051 RESISTOR POWER 10 OHM 1W 5% RF 87045 RESISTOR K OHM.5W 1% RS 87046 RESISTOR.61K OHM.5W 1% RX 8706 RESISTOR OPTIONAL OEM PCB RY 8705 RESISTOR OPTIONAL OEM PCB T1 - T14 87091 TERMINAL BLOCK SCR CLAMP U1 87150 VOLTAGE REG TO-0 SCR1, SCR 81118 SCREW 4-40 X 5/16" PHIL PAN HD HN1, HN 808 HEX NUT 4-40 FW1, FW 8019 LOCK WASHER INT NO 4 ITEM PART NO DESCRIPTION H1 0 SILICONE HEATER BAND 1V 1W 81/80 SERIES PNT HTR SHELL ASSY 0 SILICONE HEATER BAND 1V 7.W 800/500/719/700 SERIES PNT HTR SHELL ASSY 01 SILICONE HEATER BAND 1V W 84/840/840 SERIES PNT HTR SHELL ASSY RT 871901 THERMISTOR 5K OHM HTR SHELL ASSY L1 87101 LED INDICATOR FRONT PANEL TF1 871801 THERMAL CUTOFF FUSE HTR SHELL ASSY R1 00567 POTENTIOMETER 1K OHM FRONT PANEL ELECTRICAL SPECIFICATIONS Operating Voltage: 115VAC 60 Hz or 0 VAC 50Hz+%. Voltage Selector Switch On rear panel. Power Requirement: 5 Watts single PNT control 50 Watts two PNT control Leakage Current: Less than 0 Microamps Operating Temperature: 18-45 C Heater Control/PNT Warm-Up Period: 15 minutes Thermal Cutoff Fuse (TF1): Cutoff Temperature 98 Holding Temperature 76 Rated 1 amp 50 Volt Environmental Temperature: 5 to 40 C (operating) -40 to 70 C (non-operating) Humidity: up to 95% RH at or below 40 C (operating) up to 95% RH at or below 65 C (non-operating) Fuses: Replace fuses with the same type and rating 50 Volt 1/ amp. 5x0mm size. REV DESCRIPTION DATE INIT. A Released 1-74 JHR B ABS Box was Bakelite 5-8 KAR C ABS Silkscr Cover/Box was Alum. Cover 11-8 KAR Phot Etch D Alum Slope Front Cover/Base was ABS 6-87 KAR Encl. E Add Panel Mnt. Htr. Shell Cable Conn. 6-91 KAR Rear Panel Start with S/N 85-01. New Series Htr. Contr. 850 F Chg. Encl. w/int. Chassis, Front & Rear 1-9 KAR Panels. Add two PNT Series 850B G Remove rear panel slots -95 KAR H AC PWR recp. chg filter type. 5x0 mm fuses KAR x only. Mark I PCB Resistor CHGS: R7 180 was 000, 5-00 KAR R8 1600 was 000, R11 1500 was 1800 J Front Paddle switch was slide, rear circ -01 KAR conn Switch Craft was Lemo K PCB component changes 5-0 KAR L ELMA Alum Enclosure, Laser mark panels 5-09 KAR 698-14 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 15.0 MAINTENANCE. 1 Non-Heated Pneumotachometer/Heated Pneumotach & Heater Controller (Refer to Figures,, 4 & 5, S ection 6, page 8 and Figures A & B S ection 7. 0 page & S ection 8. 0, page 11).. la Disassembly of the PNT. 1. If heated PNT, turn off power to Heater Control by pushing power Switch to OFF position and unplug Heater Shell & Cable Assembly from 5 pin receptacle on back panel of Heater Controller.. Unscrew/loosen ( turns ccw) The pressure Taps (Items ). Unscrew/remove Small Flange Port Tube (item 8) 4. Pull Heater Shell or Non Heated Shell (items 1 & 1) from Body (Housing)(Item 6) gently. Do Not Use Tools or Force. CAUTION: Do Not submerge Heater Shell (G) or Heater Controller in water, detergent or any other liquid. Do not autocl ave. 5. Unscrew Large Flange Port Tube (item 7). Use spanner wrench or D- shape hole design removal tool on Small PNTs as required. 6. Carefully remove o-ring (A or B) with o-ring removal tool ( Dental Pick) P/N 905000. 7. Remove screen/spacer Sub Assembly in sequence: # ( Item 11), # (Item ),# 1 (Item 9) by tapping open body (Item 6) on flat surface such as table top. NOTE: Each Screen Sub-Assembly is marked by dots designating the location number of the screen subassembly & each screen is engraved with the PNT S/N (Serial Number) to assure reassembly to the correct housing.. 1B Inspecti on of the PNT Components. 1. Check all parts for foreign matter.. Check screen sub-assemblies for entrapped particles by holding them to light.. If parts are clean, reassemble per section.1 E instructions, page 16 4. If dry dust particles appear on screens, blow air through screens from both ends. When screens are clean again, reassemble per section.1e instructions. 5. If screens are encrusted proceed with Section.1 C instructions.. 1C Manual Cleaning of PNT Components (Refer to PNT Cleaning and Disinfection brochure 691199 for details). 1. Manual cleaning of the PNT Components is done in warm water using a neutral mild detergent. Soft brushes can be used to scrub the components where necessary. The screen assemblies may have to be soaked in an enzymatic detergent if the detergent does not breakdown the debris buildup.. Rinse all components with clean water thoroughly.. Completely dry all components. 4. Heater shell and cable assembly do not require high level disinfection. This assembly should be wiped cleaned with mild detergent or disinfection solution.. 1D High Level Disinfection of the PNT Components with Liquid Chemi cal Gl utaral dehyde (Refer to PNT Cleaning Cleaning and Disinfection brochure 691199 for details). 1. The disinfection solution must contact all surfaces of the components to ensure disinfection.. Use only liquid Glutaraldehyde disinfection solutions approved as disinfectants/sterilants by EPA and cleared for marketing use on medical devices by the FDA. For a list of approved products contact HRI.. Determine the required soak temperature and time. 4. Activate the Glutaraldehyde solution per the manufacturers instructions. ` 5. Completely immerse all the PNT components in the Glutaraldehyde solution. Cover the disinfectant soaking basin to minimize chemical vapor exposure. 6. Soak the components for the required time to achieve high level disinfection. 7. Rinse all components thoroughly. Sterile water is preferred over tap water. 8. Dry all components thoroughly prior to reassembly and storage. 9. Inspect all components for cleanliness, proper function, and defects. 698-15 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 16.0 MAINTENANCE (CONT.). 1E Reassembly of PNT (Figures,, 4 & 5, S ection 6. O Page 8) 1. Place the body (housing) (Item 6) on table with large hole opening upward (left end with alignment slot in exploded view in Section 6.0).. Select Screen Sub-Assembly (Item 9) with one dot facing up. Place it into body (housing) with alignment Pin that is on circumference of the screen sub-assembly (refer to Figure 1, Section 6.0) mating with slot in body (housing) (Item 6).. Repeat the same with the two dot screen sub-assembly (Item ). 4. Repeat the same with the three dot screen sub-assembly (Item 11). Note:Screen sub-assembly must be placed in flat to avoid binding against the body. Do Not Use Force. If screen sub-assembly does not drop flat, tap the circumference of the screen sub-assembly lightly until it lies flat. Do Not Push on the S creen Mesh. 5. Insert O-Ring (Item A) in the groove above the stacked screen subassemblies within the body (housing). In the small PNTs the two Item B O- Rings will fit over the threads and in the groove on the Large Flange Port Tube. 6. Screw the large Flange Port Tube (Item 7) tightly to the body(housing) (Item 6). 7. Replace Heater Shell or Non-Heater Shell (Items 1 & 1) on body (housing) (Item 6). 8. Screw small flange port tube (Item 8) finger-tight, to body (Item 6). 9. Screw in two pressure tap assemblies (Item ) until O-Ring (Item E) is compressed. 1/ turn. NOTE: If the pneumotachometer was heavily encrusted, and the quality of cleaning is questioned, the assembly is questionable, two or more PNT parts are mixed together and crossed or the screens or other components are damaged, the PNT should be recalibrated at Hans Rudolph, i nc. Please contact Hans Rudolph, inc. for a Return Authori zati on Number (RAN).. 1F Verifying Heater S hell & Heater Controller Plug Heater Controller Power Cord into electrical service outlet that is known to provide appropriate line voltage. Turn Screen Temperature Setting Control Knobs to maximum, fully clockwise. Set PNT Series Selection Switch to appropriate PNT group. Heating pilot light should brighten. Take Pneumotach into your hand and confirm that the body (housing) is heating up. Turn Screen Temperature Setting control knobs fully counter-clockwise. Pilot light should go out i f the ambient temperature is greater than the lower setting. If the light does not go out and the ambient temperature is greater than the lowest setting, the unit is not operating properly and should be returned for repair. If the light does not go on and the pneumotach is warm to the touch, the unit should be returned for repair. If the light does not go on and the pneumotach does not feel warm, check the fuses and the electrical service outlet for the appropriate voltage. If fuses and voltage are matched correctly contact Hans Rudolph, inc. for a Return Authorization Number (RAN) and return the unit for repair. Whenever returning a PNT and Heater Control for repair include a written description of the conditions under which they failed. When corresponding with us about your PNT and Heater Controller, or when returning the unit for service be sure to refer to the Serial Number as shown in section 6, Page 8.. Cleaning the PNT Heater Control The PNT Heater Control does not require high level disinfection or sterilization. This control enclosure can be wiped clean with a mild spray disinfectant or a water damp cloth. Wipe dry thoroughly. 698-16 014-05-05 Rev. O Prices & Specifications subject to change without notice

11.0 TYPICAL GRAPH (AS SUPPLIED WITH PURCHASE) OF THE LINEAR SIGNAL PRESSURE AND BACK PRESSURE. 81/481 (0-800 L/min) SERIES Page 17 EXAMPLE OF DATA POINTS & CALIBRATION CURVE PROVIDED WITH EACH PNEUMOTACH Makers of Respiratory Valves Since 198 Serial # 81-779 HANS RUDOLPH, Inc. Tested by GJS 85 Cole Parkway, Shawnee, KS 667 USA Date 01/4/94 Phone: 91-4-7788 FAX: 91-4-7 Toll-Free within the USA & Canada: 1-800-456-6695 RUDOLPH PNEUMOTACHOMETER (PNT) DIR 1 and DIR below show flow test in each direction through unit. Plotted graph is average of DIR 1 and DIR. order # Customer Signal pressure is upper line. P.O. # Back pressure is lower line. Date 01/4/94 Part # 11947 RUDOLPH PNEUMOTACH Series 81 BIDIRECTIONAL AND LINEAR Flow Calibration Factor.01 Signal Pressure Back Pressure (mm Water signal pressure/l/min) mm Water cm Water L/min DIR 1 DIR DIR 1 DIR TEST CONDITIONS FOR PNT CALIBRATION: Temperature- 80.00 1.79 1.77 0.4 0.4 (in degrees C) 1 160.00.80.90 0.8 0.8 Barometric Pressure- 40.00 5.0 5.059 1.4 1. (in mm Hg) 760 0.00 6.705 6.7.0.0 400.00 8.404 8.41.0.0 TEST EQUIPMENT: 480.00.09.115.8.8 Signal Pressure- 560.00 11.87 11.848 4.8 4.8 dp Transducer.08% of reading 640.00 1.550 1.570 6.0 6.0 Back Pressure- 70.00 15. 15.00 7. 7. dp Water Transducer.5% F.S. 800.00 17.00 17.060 8.6 8.5 Flow- Laminar Flow Element.5 % F.S. TYPICAL GRAPH 0-00 L/min AS S UPPLIED WITH PNT 691155 11/9 698-17 014-05-05 Rev. O Prices & Specifications subject to change without notice

Page 18 11.0 REFERENCE LITERATURE (Pneumotach Applications) 1. D.P. Johns, J.J. Prefto and J.A. Streeton. Measurement of Gas Viscosity with a Fleisch Pneumotachograph. Journal of Applied Physiology 5 (1) 90-9 198.. Minken P. Yeh, Ted D. Adams, Reed M. Gardner and Frank G. Yanowitz. Effect of 0, N, and C0 Composition on Nonlinearity of Fleisch Pneumotachograph Characteristics. Journal of Applied Physiology 56 (5) 14-145 1984.. R. Gelfand, C.J. Lambertsen, R.E. Peterson and A. Slater. Pneumotachograph for Flow and Volume Measurement in Normal and Dense Atmospheres. Journal of Applied Physiology 41 (1) 10-14 1976. 4. W. Blumenfeld, S. Turney and R.A. Cowley. Mathematical Model for Flow in the Heated Fleisch Pneumotachometer. Med Biol. Engineering 11: 546-551 197. 5. P. Vallinis, G.M. Davis and A.L. Coates. A Very Low Dead Space Pneumotachograph for Ventilatory Measurements in Newborns. Journal of Applied Physiology 69 (4) 154-1545 1990. 6. M.J. Turner, I.M. MacLeod and A.D. Rothberg. Effects of Temperature and Composition on Viscosity of Respiratory Gases. Journal of Applied Physiology 67 (1) 47-477 1989. 7. Martin R. Miller and Archie C. Pincock Linearity and Temperature Control of the Fleisch Pneumotachograph. Journal of Applied Physiology 60 () 7-715 1986. 8. Minken P. Yeh, Reed M. Gardner, Ted D. Adams and Frank G. Yanowitz. Computerized Determination of Pneumotachometer Characteristics using a Calibrated Syringe. Journal of Applied Physiology 5 (1) 80-85 198. 9. Andrew C. Jackson and Allen Vinegar. A Technique for Measuring Frequency Response of Pressure, Volume, and Flow Transducers. Journal of Applied Physiology 47 () 46-467 1979.. William J. Sullivan, Gene M. Peters and Paul L. Enright, MD. Pneumotachographs: Theory and Clinical Application. Respiratory Care 9 (7) 76-749 1984. 11. Kevin E. Finucane, Bruce E. Egan, and Stanley V. Dawson. Linearity and Frequency Response of Pneumotachographs. Journal of Applied Physiology (1) 11-16 197. 1. Pulmonary Function Testing Guidelines and Controversies, Equipment Methods and Normal Valves. Edited by Jack L. Clausen, M.D. Chapter 9, Pneumotachography by Arthur Dawson, M.D., pages 91-97. Copyright (01 98 by Academic Press, Inc. N.Y., N.Y. 698-18 014-05-05 Rev. O Prices & Specifications subject to change without notice

11.0 REFERENCE LITERATURE (Pneumotach Applications) (Cont.) Page 19 1. H. Von Der Hardt and C.H. Zywietz. Reliability in Pneumotachograhic Measurements. Respiration 416-44 1976. 14. Enid R. Kafer, MD. Errors in Pneumotachography as a result of Transducer Design and Function. Anesthesiology 8 75-79 197. 15. Richard J. Lemen, Clarence B. Gerdes, Michael J. Wegmann and Keith J. Perrin. Frequency Spectra of Flow and Volume Events for Forced Vital Capacity. Journal of Applied Physiology 5 (4) 977-984 198. 16. Richard E. Frye and Richard L. Doty. A Comparison of Response Characteristics of Airflow and Pressure Transducers Commonly used in Rhinomanometry IEEE Trans. Bio. Engineering. 7 () 97-944 1990. 17. C.B. McCall, R.E. Hyatt, F.W. Nobel and D.L. Fry. Harmonic Content of Certain Respiratory Flow Phenomena of Normal Individuals. Journal of Applied Physiology 15-18 1957. 18. Peter E. Renzi, Christine A. Giurdanelia and Andrew C. Jackson. Improved Frequency Response of Pneumotachometers by Digital Compensation. Journal of Applied Physiology 68 (1) 8-86 1990. 19. A. Grenvick, U. Hedstrand and H. Sjogren. Problems in Pneumotachography. ACTA Anesthesiol Scand () 147-155 1966. 0. Eugene N. Bruce and Andrew C. Jackson. Smoothing of MEFV Curves by Digital Filtering of Flow as Function of Volume. Journal of Applied Physiology 48 (1) 0-06 1980. 698-19 014-05-05 Rev. O Prices & Specifications subject to change without notice