Pulmodyne O2-MAX Disposable CPAP System for EMS and Hospital Use

The Pulmodyne O2-MAX is a disposable, single-patient-use CPAP system for spontaneously breathing adults over 30 kg in hospital and prehospital (EMS) care. Its fixed-flow venturi generator runs on a 50 psi oxygen source, delivers up to 140 LPM at about 30% FiO2, and holds PEEP with a 3-SET, 5-SET or fixed valve, independent of the patient's flow.12 Air is filtered in both directions.3 Pacific Biomedical offers O2-MAX part numbers 313-7538X, 313-7554XN-1, 313-7555X, 313-7555XN-1, 313-7556X, 313-7556XN-1 and 313-7557XN-1 to order online in cases of 10 systems, and the rest of the O2-MAX line, including O2-MAX Trio, by quote.

Choose Your O2-MAX System:

Each part number is a case of 10 complete systems: generator with inhalation filter, 72 in circuit, PEEP valve, BiTrac ED mask with headgear and O2-MAX Guard exhalation filter.12 N adds the nebulizer, -1 adds a pre-attached Ohmeda Quik-Connect, and X is the expandable circuit.2 Shop opens the system page. Quote sends the part number to Pacific Biomedical customer service.

Part Number Mask, PEEP Neb, Fitting Order
313-7538X Medium, 10 cmH2O No, DISS Shop
313-7554XN-1 Large, 5-SET Yes, Quik-Connect Shop
313-7555X Large, 3-SET No, DISS Shop
313-7555XN-1 Large, 3-SET Yes, Quik-Connect Shop
313-7556X Medium, 3-SET No, DISS Shop
313-7556XN-1 Medium, 3-SET Yes, Quik-Connect Shop
313-7557XN-1 Medium, 5-SET Yes, Quik-Connect Shop
313-7554X Large, 5-SET No, DISS Quote
313-7554XN Large, 5-SET Yes, DISS Quote
313-7555XN Large, 3-SET Yes, DISS Quote
313-7556XN Medium, 3-SET Yes, DISS Quote
313-7557X Medium, 5-SET No, DISS Quote
313-7557XN Medium, 5-SET Yes, DISS Quote

Which fitting do I need? Every O2-MAX needs a 50 psi oxygen source, not a flowmeter.1

  • Ohmeda wall outlet: choose a -1 part number. The Ohmeda Quik-Connect comes attached.2
  • Cylinder regulator with a 50 psi DISS outlet: choose a part number without -1: 313-7538X, 313-7555X or 313-7556X, or with a nebulizer 313-7554XN, 313-7555XN, 313-7556XN or 313-7557XN by quote.24
  • Chemetron, Puritan Bennett or Schrader wall outlet: choose a part number without -1 and add the matching Quik-Connect: 313-121111, 313-131111 or 313-141111 (by quote).5

O2-MAX Trio Systems:

Trio systems add a knob that sets about 30, 60 or 90%+ FiO2. They come with an expandable circuit, with or without the nebulizer.62 The Trio control unit, part number 313-8000, converts a Fixed generator to a Trio, and cannot be used alone.782 All Trio part numbers are by quote.

Part Number Mask, PEEP Neb, Fitting Order
313-8007X Medium, 3-SET No, DISS Quote
313-8007XN Medium, 3-SET Yes, DISS Quote
313-8007XN-1 Medium, 3-SET Yes, Quik-Connect Quote
313-8008XN Medium, 5-SET Yes, DISS Quote
313-8017X Large, 3-SET No, DISS Quote
313-8017XN Large, 3-SET Yes, DISS Quote
313-8017XN-1 Large, 3-SET Yes, Quik-Connect Quote
313-8018XN Large, 5-SET Yes, DISS Quote
313-8000 Control unit only N/A Quote

Product Highlights:

  • High flow from a 50 psi source. The venturi generator connects directly to a 50 psi oxygen source and entrains room air to deliver up to 140 LPM at about 30% FiO2. The PEEP valves maintain positive pressure at flows from 60 to 140 LPM.1
  • PEEP set by the valve, not the flowmeter. 3-SET (5, 7.5, 10), 5-SET (5 to 15) or fixed valves (2.5 to 20 cmH2O) hold PEEP independent of the patient's flow rate.921
  • Filtered in and out. An inhalation filter on the generator and the pre-attached O2-MAX Guard exhalation filter. Filter efficiency is more than 99.99% bacterial and viral.23
  • Nebulize during CPAP. N systems include a nebulizer canister that pushes into the nebulizer port with a quarter turn. The filter sits before the nebulizer port, so it saturates with medication less than an in-line filter would, and flow to the patient stays consistent.132
  • Up to 28 minutes on a D cylinder (Fixed system), or run it from the vehicle or hospital wall outlet.25
  • Select 30, 60 or 90% FiO2 with Trio. Trio systems, or a Fixed generator fitted with the Trio control unit (313-8000), set about 30, 60 or 90%+ FiO2 with a knob.687
  • Ready to apply. No assembly. The BiTrac ED mask comes with pre-attached headgear and the adjustable Omni Clip, on a 72 in anti-asphyxia circuit with expandable tubing. Check airflow and valve function before use.19210
  • Quik-Connect ready. -1 systems come with a disposable Ohmeda Quik-Connect that plugs into an Ohmeda wall outlet and moves with the patient from bedside to ambulance.259

Works With:

Oxygen source 50 psi (about 4 bar) oxygen only. Connect directly to a 50 psi outlet: an ambulance or hospital wall outlet, or a cylinder regulator with a 50 psi DISS outlet such as the Gentec 284MA-15LY1. It connects to the 50 psi outlet, not to a flowmeter barb.14
Connection Part numbers without -1 (such as 313-7555X): DISS connection on the oxygen hose. Part numbers with -1 (such as 313-7554XN-1): Ohmeda Quik-Connect, pre-attached. Replacement Ohmeda Quik-Connect 313-111111, case of 30.25
Masks BiTrac ED, adult medium or large, ships with the system. Replacement masks: 313-7028 small, 313-7029 medium, 313-7030 large.2
PEEP valves Snap onto the anti-asphyxia housing end of the circuit, seated fully onto the O2-MAX Guard filter. See the valve chart below.110
Monitoring No gauge in the kit: add an in-line pressure gauge or manometer, 0 to 30 cmH2O, per local protocol, plus SpO2.1 NASEMSO guidelines call for pulse oximetry and EtCO2 in respiratory distress.11 Pacific Biomedical carries AirLife adult EtCO2/O2 sampling cannulas.
Patients Spontaneously breathing adults over 30 kg.1
Care settings Hospital and prehospital (EMS).1

PEEP Valves and Colors:

O2-CPAP valves snap onto the end of the O2-MAX circuit and maintain positive pressure at flows from 60 to 140 LPM.1 Swap a valve to change PEEP, or replace a valve that becomes occluded.112 Each valve part number is a case of 10.13 The standalone O2-MAX Guard exhalation filter is part number 313-8300 (Quote).3

Part Number Valve, PEEP (cmH2O) Color Order
313-7725 3-SET adjustable, 5, 7.5 or 10 White Quote
313-7730 5-SET adjustable, 5, 7.5, 10, 12.5 or 15 Gray Quote
313-7715 Fixed, 2.5 White Quote
313-7716 Fixed, 5.0 Blue Quote
313-7717 Fixed, 7.5 Yellow Quote
313-7718 Fixed, 10.0 Green Quote
313-7719 Fixed, 12.5 Pink Shop
313-7720 Fixed, 15.0 Red Shop
313-7721 Fixed, 20.0 Gold Shop

Specifications:

Manufacturer Pulmodyne Inc., Indianapolis, Indiana
Device Fixed-flow venturi CPAP generator with inhalation filter, 72 in anti-asphyxia circuit, O2-CPAP PEEP valve and O2-MAX Guard exhalation filter1
Oxygen source 50 psi (about 4 bar), oxygen only1
Flow to patient Up to 140 LPM; lower with the Guard filter attached123
FiO2 About 30% (Fixed). About 30, 60 or 90%+ (Trio).16
PEEP 3-SET 5, 7.5 or 10 cmH2O. 5-SET 5, 7.5, 10, 12.5 or 15 cmH2O. Fixed valves 2.5 to 20 cmH2O.29 With the Guard filter attached, delivered PEEP runs about 1.5 cmH2O above the valve setting.3
Run time Up to 28 minutes on a D cylinder (Fixed system)2
Filtration Inhalation filter and pre-attached O2-MAX Guard exhalation filter. Filter efficiency more than 99.99% bacterial and viral. Replace the Guard filter at least every 24 hours.2310
Nebulizer Included on N systems; the canister pushes into the nebulizer port1
Mask BiTrac ED, adult medium or large, pre-attached headgear with Omni Clip29
Circuit 72 in anti-asphyxia circuit, expandable tubing12
Connection DISS, or Ohmeda Quik-Connect on -1 systems2
Patients Spontaneously breathing adults over 30 kg1
Use Single patient use. No assembly. Do not sterilize or immerse.1
Operating conditions 5 to 40 degrees C (41 to 104 degrees F), 15% to 95% humidity1
Storage conditions -20 to 60 degrees C (-4 to 140 degrees F), up to 95% relative humidity, non-condensing1
FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure)14
Case quantity 10 systems per case2

O2-MAX vs Flow-Set Disposable CPAP:

Disposable EMS CPAP comes in two common designs. A flow-set CPAP uses the oxygen flowmeter as the pressure control: more oxygen flow, more PEEP, checked on a manometer. The O2-MAX separates the two: a 50 psi oxygen source drives a high-flow venturi, and the valve on the circuit sets PEEP.19 The table compares the O2-MAX with a flow-set disposable CPAP that has a built-in color-coded manometer and an integrated-nebulizer version. Flow-set values come from that design's published flow-to-PEEP chart and instructions.

Feature Pulmodyne O2-MAX Flow-set disposable CPAP (PEEP set by oxygen flow)
How PEEP is set Valve on the circuit: 3-SET (5, 7.5, 10), 5-SET (5 to 15) or fixed (2.5 to 20 cmH2O), independent of the patient's flow91 Raise or lower oxygen flow on the flowmeter, then read the manometer
Oxygen source 50 psi outlet: wall outlet or a regulator's 50 psi DISS port1 Flowmeter, about 8 to 9 LPM for 5 cmH2O and 13 to 14 LPM for 10 cmH2O
Flow to the patient Up to 140 LPM. Valves hold PEEP at 60 to 140 LPM.1 Set by the oxygen flow
FiO2 About 30% (Fixed). About 30, 60 or 90%+ with Trio.16 Varies with breathing, about 70 to 75% in CPAP mode for an average adult
Turning on the nebulizer Nebulizer canister in the nebulizer port at the mask end of the circuit, with a consistent flow to the patient12 Integrated-nebulizer version: CPAP pressure drops when the nebulizer turns on
D cylinder run time Up to 28 minutes (Fixed system)2 About 40 minutes at 5 cmH2O, shorter at higher PEEP
Pressure check No manometer in the kit. Watch the valve stay open on inspiration; add an in-line gauge, 0 to 30 cmH2O, per protocol.1 Built-in color-coded manometer
Patients Adults over 30 kg1 Adult and child mask sizes

Need a CPAP that runs from a flowmeter? Pulmodyne's GO-PAP disposable emergency CPAP runs on a fixed 10 LPM from a metered oxygen supply, about 40 minutes per D cylinder, with PEEP set at 5, 7.5 or 10 cmH2O on the generator.15

Replacing a flow-set disposable CPAP? Check the oxygen supply first: the O2-MAX connects to a 50 psi outlet, not a flowmeter, and PEEP moves from the flowmeter to the valve, so crews choose a valve setting instead of reading a flow-to-PEEP chart.19

Who Uses This:

  • EMS Agencies and Fire Departments: high flow for severe respiratory distress,111 PEEP chosen with the valve, nebulizer systems for in-line treatments, and filtered exhalation in the patient compartment.23 Compare all disposable EMS CPAP devices.
  • EMTs, Paramedics and BLS Crews: PEEP is a valve setting rather than a flow calculation,9 for agencies whose scope and protocols include CPAP at the EMT, AEMT or paramedic level.16
  • Emergency Departments and Hospitals: labeled for hospital as well as prehospital use. The Quik-Connect plugs into the wall outlet and moves with the patient between rooms and to the ambulance.15
  • Critical Care and Interfacility Transport: Trio systems set about 30, 60 or 90%+ FiO2 for patients who need more oxygen, with continuous pulse oximetry.6

Related Products:

Product Guides and Documents:

Frequently Asked Questions:

What is the Pulmodyne O2-MAX CPAP and how does it work?

The Pulmodyne O2-MAX (also written O2 MAX, 02 MAX or 02-MAX) is a disposable fixed-flow venturi CPAP. Oxygen from a 50 psi source drives the generator, which entrains room air and delivers up to 140 LPM to the mask at about 30% FiO2. An O2-CPAP valve on the circuit holds PEEP through inspiration and exhalation, independent of the patient's flow rate, and filters clean the air in both directions.13

What oxygen supply does the O2-MAX need?

A 50 psi (about 4 bar) oxygen source. Connect the O2-MAX directly to a 50 psi outlet: an ambulance or hospital wall outlet, or a cylinder regulator with a 50 psi DISS outlet, such as the Gentec 284MA-15LY1. It does not run from a flowmeter barb. Use oxygen only, and disconnect it from the source when not in use.14

Which oxygen fitting does the O2-MAX need: DISS or Quik-Connect?

It depends on the outlet. For an Ohmeda wall outlet, choose a -1 part number, which comes with the Ohmeda Quik-Connect attached. For a cylinder regulator with a 50 psi DISS outlet, choose a part number without -1. For a Chemetron, Puritan Bennett or Schrader wall outlet, choose a part number without -1 and add the matching Quik-Connect: 313-121111, 313-131111 or 313-141111. Every O2-MAX needs a 50 psi source, not a flowmeter.251

How long does a D cylinder last on the O2-MAX?

Up to 28 minutes of run time on a D cylinder with a Fixed system.2 Run time at the Trio 60% and 90% settings is not specified. For longer transports, run the O2-MAX from the vehicle's main oxygen supply through a 50 psi wall outlet: -1 systems plug into Ohmeda-type outlets, and other outlet types take the matching Quik-Connect (nine types are made).15

How many LPM and what FiO2 does the O2-MAX CPAP deliver?

Up to 140 LPM to the patient at about 30% FiO2 on Fixed systems, from a 50 psi oxygen source. There is no flowmeter setting and no flow-to-PEEP chart: the valve sets PEEP, which holds at flows from 60 to 140 LPM.1 Trio systems, or a Fixed generator with the Trio control unit (313-8000), deliver about 30, 60 or 90%+: turn the knob until the setting is fully visible in the window, or about 30% is delivered. Monitor SpO2, and use an oxygen analyzer for an exact FiO2.68

How do I set PEEP on the O2-MAX?

PEEP is set with the valve on the circuit, not the flowmeter. Twist the top of the white 3-SET valve to 5, 7.5 or 10 cmH2O; the gray 5-SET valve covers 5, 7.5, 10, 12.5 and 15 cmH2O; fixed valves are color coded from 2.5 to 20 cmH2O. Watch that the valve stays open during inspiration, and set PEEP per local protocol.921 With the pre-attached Guard filter, PEEP runs about 1.5 cmH2O above the valve setting.3

Can I give albuterol through the O2-MAX for reactive airway, asthma or COPD patients?

Yes, with an N system, when protocol calls for an in-line bronchodilator in reactive airway disease. Push the nebulizer canister into the nebulizer port with a quarter turn, set the gas flow and check for mist. The filter sits before the nebulizer port, so it saturates with medication less than an in-line filter would.13 NASEMSO guidelines advise giving bronchodilators in line with NIV when indicated.11 CPAP evidence in asthma is limited,17 and guidelines favor bilevel NIV for acidotic COPD,18 so follow local protocol.

Does the O2-MAX filter exhaled air, and how often is the filter changed?

Yes. The O2-MAX Guard exhalation filter comes pre-attached and the generator has an inhalation filter, so air is filtered in both directions; filter efficiency is more than 99.99% bacterial and viral.32 Replace the Guard filter at least every 24 hours, or sooner if resistance rises; the standalone Guard filter is part number 313-8300.210 With the filter attached, PEEP runs about 1.5 cmH2O above the valve setting and maximum flow is lower than the 140 LPM rating, so confirm delivered pressure on an in-line manometer per protocol.3

Can EMTs, paramedics and BLS crews use the O2-MAX CPAP?

Yes, when trained and within protocol. The O2-MAX is labeled for thoroughly trained personnel in hospital and prehospital (EMS) care.1 The 2019 National EMS Scope of Practice Model lists CPAP at the EMT, AEMT and paramedic levels, and each state sets its own scope and agency protocol.16

Is prehospital CPAP used for congestive heart failure (CHF) and pulmonary edema?

Yes. ERS/ATS guidelines recommend CPAP or bilevel NIV for cardiogenic pulmonary edema and suggest it in the prehospital setting.18 A 2019 Cochrane review of 24 trials, in emergency department and inpatient settings, found that CPAP or bilevel NPPV probably reduced intubation (risk ratio 0.49, moderate certainty).19 Choose and titrate PEEP per local protocol.

What are the contraindications for the O2-MAX CPAP?

The O2-MAX may be contraindicated with facial lacerations, laryngeal trauma, recent tracheal or esophageal anastomosis, gastrointestinal bleeding or ileus, recent gastric surgery, basilar skull fracture, high risk of vomiting, emphysematous bulla or hypovolemia. It is for spontaneously breathing adults over 30 kg. With no oxygen flow from the generator, remove the mask.1

Is this a genuine Pulmodyne O2-MAX?

Yes. Pacific Biomedical is an authorized Pulmodyne distributor. Every O2-MAX ships new in its original Pulmodyne packaging.

How fast does the O2-MAX ship?

Most orders ship within 1 to 2 business days, and current availability shows on each system page. Expedited and overnight shipping are available at checkout.

How do I order the O2-MAX or request a quote?

Select Shop beside a part number in the system chart to open its page and add it to your cart. For a part marked Quote, use that link, or contact CustomerService@pacificbiomedical.com or 844.436.3526 with the part number. Pacific Biomedical supports net terms for agencies and hospitals and ships to all 50 states.

References
  1. Pulmodyne Inc. O2-MAX Fixed System With Nebulizer, Directions for Use, 2764G (2022). pulmodyne.com.
  2. Pulmodyne Inc. O2-MAX Disposable CPAP Device brochure and ordering guide, 2812H (2022). pulmodyne.com.
  3. Pulmodyne Inc. O2-MAX Frequently Asked Questions (filter, nebulizer, part numbers).
  4. GenStar Technologies. Gentec 284 and 285 Series click-style oxygen regulators, specifications (DISS outlet models, 50 psi delivery pressure). genstartech.com.
  5. Pulmodyne Inc. Quik-Connect disposable DISS gas fittings, qc-8292. pulmodyne.com.
  6. Pulmodyne Inc. O2-MAX Trio System, Directions for Use, 2260F (2022). pulmodyne.com.
  7. Pulmodyne Inc. O2-MAX Trio Control Unit, Directions for Use, 2261D (2022). pulmodyne.com.
  8. Pulmodyne Inc. O2-MAX Fixed System, Directions for Use, 3512G (2022). pulmodyne.com.
  9. Pulmodyne Inc. O2-MAX product page (PEEP valves, Quik-Connects, Omni Clip, part list). pulmodyne.com.
  10. Pulmodyne Inc. O2-MAX Guard Filter, Directions for Use, 3076C. pulmodyne.com.
  11. National Association of State EMS Officials. National Model EMS Clinical Guidelines, Version 3.0 (2022), Respiratory Distress: NIV by CPAP, bronchodilators in line with NIV, pulse oximetry and EtCO2. nasemso.org.
  12. Pulmodyne Inc. O2-CPAP Valve, Directions for Use, 3645. pulmodyne.com.
  13. Pulmodyne Inc. Accessories brochure (O2-CPAP and 3-SET/5-SET PEEP valves), 5805E (2022). pulmodyne.com.
  14. U.S. Food and Drug Administration. AccessGUDID device records, brand O2-MAX and O2-CPAP, Pulmodyne Inc. (product code BYE, single use, GTINs). accessgudid.nlm.nih.gov.
  15. Pulmodyne Inc. GO-PAP Disposable CPAP Device brochure and ordering guide, 2503F (2022). pulmodyne.com.
  16. National Highway Traffic Safety Administration. National EMS Scope of Practice Model 2019 (CPAP at the EMT, AEMT and paramedic levels). ems.gov.
  17. Lim WJ, Mohammed Akram R, Carson KV, et al. Non-invasive positive pressure ventilation for treatment of respiratory failure due to severe acute exacerbations of asthma. Cochrane Database Syst Rev. 2012;12:CD004360. pubmed.ncbi.nlm.nih.gov.
  18. Rochwerg B, Brochard L, Elliott MW, et al. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017;50(2):1602426. pubmed.ncbi.nlm.nih.gov.
  19. Berbenetz N, Wang Y, Brown J, et al. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema. Cochrane Database Syst Rev. 2019;4:CD005351. pubmed.ncbi.nlm.nih.gov.
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