Low Flow / High Flow R203Pxx Instructions for Use Rev D

Maxtec 2305 South 1070 West Salt Lake City, Utah 84119 USA

phone: (800) 748.5355 fax: (801) 973.6090 email: sales@maxtec.com web: www.maxtec.com

NOTE: The latest edition of this operating manual can be downloaded from our website at www.maxtec.com

RECEIVING / INSPECTION

DANGER

Remove the MicroMax Air-Oxygen Blender from the packaging and inspect for damage. If there is any damage, DO NOT USE and contact your Provider.

This product is not intended as a life-sustaining or life-supporting device.

WARNINGS

INTENDED USE

The MicroMax Air-Oxygen Blender dispenses a continuous and precise blend of medical air and USP oxygen via outlet ports to infant, pediatric and adult patients. The exact Fractional Concentration of Inspired Oxygen (FIO2) blend of gases corresponds to the dialed in FIO2 setting indicated by the control knob (dial).

READ ALL INSTRUCTIONS BEFORE USING

This manual instructs a Professional to install and operate the Air-Oxygen Blender. This is provided for your safety and to prevent damage to the Air-Oxygen Blender. If you do not understand this manual, DO NOT USE the Air-Oxygen Blender and contact your Provider.

LIMITED WARRANTY AND LIMITATION OF LIABILITY

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Only trained, qualified medical personnel under the direct supervision of a licensed physician should operate the Air-Oxygen Blender .

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Use this Air-Oxygen Blender only for its Intended Use as described in this manual.

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Confirm prescribed dose before administering to patient. Monitor on a frequent basis.

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The Air-Oxygen Blender shall be serviced by a qualified service technician.

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Always follow ANSI and CGA standards for Medical Gas Products, Flowmeters and Oxygen Handling.

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The stand-alone gas mixer is not suitable for use with O2 93.

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An Oxygen Analyzer/Monitor must be used to verify oxygen concentration.

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Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 l/min for the High Flow Blender, and 3 l/min for the Low Flow Blender.

Maxtec warrants that the Blender, (the Product), will be free of defects in workmanship and/ or material for the following period: Two (2) years from shipment.

DO NOT obstruct the alarm. DO NOT use Blender when alarm is sounding.

Should any failure to conform to this warranty appear within the applicable period, Maxtec shall, upon written notification thereof and substantiation that the goods have been stored, installed, maintained and operated in accordance with the product instructions and standard industry practice, and that no modifications, substitutions, or alterations have been made to the goods, correct such defect by suitable repair or replacement at its own expense.

DO NOT use oil in or around the Blender. DO NOT occlude or obstruct the bleed port on the auxiliary outlet of the Blender. DO NOT use near any type of flame or flammable/explosive substances, vapors or atmosphere.

ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES.

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The representatives of Maxtec or any retailers are not authorized to make oral warranties about the merchandise described in this contract, and any such statements shall not be relied upon and are not part of the contract for sale. Thus, this writing is a final, complete and exclusive statement of the terms of that contract.

Oxygen Concentration Dial does not rotate 360 degrees. Rotating the dial less than 21% or over 100% oxygen will damage the Blender.

CAUTIONS

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY, WHETHER EXPRESS OR IMPLIED. Maxtec shall not under any circumstances be liable for special, incidental or consequential damages including but not limited to lost profits, lost sales, or injury to person or property. Correction of non-conformities as provided above shall constitute fulfillment of all liablities of Maxtec whether based on contract, negligence, strict tort or otherwise. Maxtec reserves the right to discontinue manufacture of any product or change product materials, designs, or specifications without notice.

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Federal (USA) law restricts this device to sale by or on the order of a physician.

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Turn off gas supplies when Air-Oxygen Blender is not in use.

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Store the Air-Oxygen Blender in a clean, dry area when not in use.

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The Air-Oxygen Blender contains magnetic, ferrous material that may affect the results of an MRI.

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Ensure all connections are tight and leak free.

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Avoid excessive pressure surges greater than 100 psi (6.9 bar) when pressuring the Blender inlets. DO NOT steam autoclave.

Maxtec reserves the right to correct clerical or typographical errors without penalty.

DO NOT immerse Air-Oxygen Blender into any liquid. DO NOT gas sterilize with (EtO) Ethylene Oxide. DO NOT use if dirt or contaminants are present on or around the Blender or connecting devices.

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Auxiliary Outlet Flow Range... 0-30 l/min With both supply pressures at 50 psi (3.4 bar) with BLEED open Bleed Flow...3 l/min or less at 50 psi (3.4 bar) Maximum Combined Flow (All Outlets)...≥ 30 l/min Bypass Flow (Loss of Air or Oxygen supply)... > 45 l/min Bypass Alarm Activation 50 psi (3.45 bar)...18-22 psi (1.2-1.5 bar) Bypass Alarm Activation 60 psi (4.14 bar)... 16-24 psi (1.1-1.65 bar) Alarm Reset... When pressure differential is 6 psi (0.4 bar) or less Alarm Sound Level... ≥ to 80 db at 1 ft (0.3 m) Oxygen Concentration Adjustment Range...21-100% Gas Supply Pressure... 30 - 75 psi (2.1 - 5.2 bar) Air and Oxygen within 10 psi (0.69 bar) of each other Mixed Gas Stability...±1% Oxygen Connection Types...DISS Type - Air & Oxygen Inlets & Outlets and / or NIST Type - Air & Oxygen Inlets

DO NOT smoke in an area where oxygen is being administered. DO NOT clean with aromatic hydrocarbons. ◆

Inlet pressure of device used in conjunction with Blender must match inlet pressure of Blender.

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When using a bottled high pressure gas source, always use a pressure reducing regulator set within 30-75 psi (2.1-5.2 bar).

EXPLANATION OF ABBREVIATIONS

FIO2...Fractional Concentration of Inspired Oxygen DISS...Diameter Indexed Safety System NIST... Non-Interchangeable Screw Thread psi...Pounds Per Square Inch l/min...Liters Per Minute

SYMBOL GUIDE

NOTE: All flow-rate values are as measured from an Oxygen flowmeter (uncorrected).

Consult accompanying documents

Use No Oil

DANGER – Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

CAUTION – Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

WARNING – Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Federal law (USA) restricts this device to sale by or on order of a physician.

Dimensions (without fittings) Depth...4.9 in (12.5 cm) Width...2.3 in (5.7 cm) Height... 4.1 in (10.4 cm) Weight... 2.29 lbs (1.04 kg) Shipping Weight...2.95 lbs (1.34 kg) Operating Temperature Range...59°F to 104°F (15°C to 40°C)

Storage Temperature Range

Transport / Storage Requirements Temperature Range...-10°F to 140°F (-23°C to 60°C) Humidity... Max 95% Noncondensing FIO2 Accuracy*...± 3% of full scale Pressure Drop (Low Flow)...≤ 2 psi (0.14 bar) at inlet pressures from 30-90 psi (2.1- 6.2 bar) and at 10 l/min flow rate at 60% FIO2 Pressure Drop (High Flow)...≤ 3 psi (0.21 bar) at inlet pressures from 30-90 psi (2.1- 6.2 bar) and at 30 l/min flow rate at 60% FIO2 The Air-Oxygen Blender has been cleaned for Oxygen Service prior to delivery.

Date of Manufacture

Humidity

The Air-Oxygen Blender reverse gas flow complies with clause 6 of ISO 11195.

Medical Device

Serial Number

Catalog Number

Lot code/Batch code

Authorized Representative in the European Community

DO NOT Manufacturer

50°C (122°F) -15°C (5°F)

The Oxygen Analyzer should comply with ISO 80601-2-55. Dryness and Composition for inlet gases Air... Medical Air supply should meet the requirements of ANSI Z86.1 - 1973 commodity specification for Air, type 1 grade D or better Oxygen... Oxygen supply must meet all requirements of USP Medical Oxygen Grade N Dew Point...Both inlets should remain 10°F (5.55°C) or more below the lowest temperature to which the air distribution system equipment is exposed. At a temperature of 25°F (-3.9°C) and a pressure of 90 psi (6.33 kg/cm2) this equates to 2000 mg/m3. * Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 l/min for the high flow Blender, and 3 l/min for the low flow Blender.

SPECIFICATIONS MicroMax High Flow Primary Outlet Flow Range...15-120 l/min With both supply pressures at 50 psi (3.4 bar) with BLEED closed Auxiliary Outlet Flow Range...2-100 l/min With both supply pressures at 50 psi (3.4 bar) with BLEED open Bleed Flow...13 l/min or less at 50 psi (3.4 bar) Maximum Combined Flow (All Outlets)...≥ 120 l/min Bypass Flow (Loss of Air or Oxygen supply)... > 85 l/min Bypass Alarm Activation 50 psi (3.45 bar)... 13-25 psi (0.9-1.7 bar) Bypass Alarm Activation 60 psi (4.14 bar)... 16-24 psi (1.1-1.65 bar)

Specifications are subject to change without prior notice. CAUTION: Missing or illegible labels must be replaced, contact Maxtec. Depending on model, your fittings and/or labels may differ from these diagrams.

MicroMax Low Flow Primary Outlet Flow Range...3-30 l/min With both supply pressures at 50 psi (3.4 bar) with BLEED closed

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ax microm ™

N XYGE AIR/O DER BLEN

60

OW

LOW FL

8 3 4 7

70

50

80 40

2

90 30 21 O2%

1

100

5 6 COMPONENT DESCRIPTION

Pre-Use Testing consists of: • Alarm Test • Reverse Gas Flow Procedure 1. Secure the Air-Oxygen Blender to a wall or pole bracket in an upright position. 2. It is recommended to install a condensation trap in the air supply line. 3. Connect the air and oxygen supply lines to the appropriate inlet fittings on the bottom of the Blender. 4. Attach a flowmeter, or other metering device to one of the outlet ports and verify FIO2 range for accuracy with an oxygen analyzer.

1 OXYGEN CONCENTRATION DIAL - A dial used for selecting oxygen concentrations between 21%-100%. The FIO2 scale is used for reference only. This Dial does not rotate 360°. The dial starts at 21% and ends at 100%.

2 PRIMARY OUTLET PORT - A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device, such as a flowmeter.

3 AUXILIARY OUTLET PORT - A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device, such as a flowmeter. This outlet is equipped with a bleed valve that allows the user to control if the bleed is ON or OFF. With the bleed in the ON position, this outlet delivers accurate oxygen concentrations in the following flows: 2–100 l/min (high flow), 0–30 l/min (low flow).

Primary Outlets Flow capacity: • High Flow Blender (R203P14 Model) 15 l/min to 120 l/min • Low Flow Blender (R203P13 Model) 3 l/min to 30 l/min Auxiliary Outlet: The auxiliary flow outlet maintains the same flow capacity and FIO2 accuracy as the Primary Outlets with Bleed Valve not engaged. When bleed flow is activated, some of the air/oxygen mixture will vent to atmosphere to maintain FIO2 concentration accuracy at the Low Flow settings.

4 AUXILIARY BLEED COLLAR - The collar is used to engage and disengage the bleed. The bleed is necessary to maintain accurate FIO2 Concentration below 15 l/min for the High Flow and ≤ 3 l/min for the Low Flow. To activate the bleed, slide the knurled collar back until it contacts the cover. To deactivate the bleed, pull the collar away from cover until it reaches a positive stop.

High Flow Blender (R203P14 Model) 15 l/min or less Low Flow Blender (R203P13 Model) 3 l/min or less 5. Attach a supply line to the outlet port of the flowmeter. •

5 OXYGEN INLET FITTING - A female DISS or NIST oxygen fitting with one way valve that

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is used to connect an oxygen supply hose.

6 AIR INLET FITTING - A male DISS or NIST air fitting with one way valve that is used to ALARM TEST connect an air supply hose. 1. Connect the Air-Oxygen Blender to air and oxygen sources, pressurize the Blender 7 ALARM - An audible alarm that sounds due to an excessive pressure drop or deletion of and turn “ON” the flowmeter. either gas supply.

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2. Set Oxygen Concentration Dial to 60% FIO2. 3. Disconnect or turn “OFF” the air supply to the Air-Oxygen Blender. The Blender should alarm with a loud whistle noise. The whistle indicates the alarm is operating correctly. 4. Reconnect and activate the air supply line to the Blender, the alarm should stop whistling. 5. Disconnect or turn “OFF” the oxygen supply line to the Blender. The whistle indicates the alarm is operating correctly. 6. Reconnect and activate the oxygen supply line to the Blender, the alarm should stop whistling. 7. If alarm fails to function properly, DO NOT USE.

REAR SLIDE MOUNT WITH DOVE TAIL

PRE-USE TESTING WARNING: Read this User Manual before installing or operating the Air-Oxygen Blender. Confirm the concentration of air/oxygen with an Oxygen Analyzer/Monitor. CAUTION: Inspect the Air-Oxygen Blender for visual damage before use, if damaged.

DO NOT USE

NOTE: The tests listed below should be performed prior to placing the Blender in service. ENGLISH

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REVERSE GAS FLOW PROCEDURE

MAINTENANCE

1. Disconnect the oxygen hose from the gas source. Remove all outlet connections from the Blender to ensure that there is no outlet flow. 2. While gradually increasing the air supply pressure from 30-75 psi (2.07-5.17 bar) check for leakage past the oxygen inlet check valve. 3. Replace the Duckbill Check Valve in the oxygen inlet if leakage is > 100 ml/min. Reference Air-Oxygen Blender Service Manual (P/N R203M15). 4. Repeat steps 1-3 to check for leakage past the air inlet check valve.

The following maintenance on the Air-Oxygen Blender must be performed by a trained service technician: • •

OPERATING INSTRUCTIONS CAUTION: Inspect the Air-Oxygen Blender for visual damage before use, if damaged. 1. 2. 3. 4.

• •

DO NOT USE

TECHNICAL DESCRIPTION

Secure Blender to wall or pole mount bracket. Connect Air and Oxygen supply lines from Blender to wall outlets. Connect flowmeter to Blender outlet. Adjust the Oxygen Concentration Dial to the prescribed concentration.

NOTE: The Oxygen Concentration Dial does not rotate 360°. or over 100% oxygen, this will damage the Blender.

The alarm should be tested prior to being placed into clinical service and periodically there after. Every year conduct the Operational Verification Procedure (OVP).* A detailed description of the OVP tests can be found in the Blender Service Manual (P/N R203M15), available on the Internet; www.maxtec.com. Every 2 years the Air-Oxygen Blender should be serviced. Refer to the Air-Oxygen Blender Service Manual (P/N R203M15) for complete details regarding further maintenance and testing.

For a complete Technical Description of the Air-Oxygen Blender and list of Replacement Parts, reference the Air-Oxygen Blender Service Manual (P/N R203M15) available on the Internet: www.maxtec.com.

RETURNS

DO NOT force dial less than 21%

Returned products require a Returned Material Authorization (RMA) number, contact Maxtec. All returns must be packaged in sealed containers to prevent damage. Maxtec will not be responsible for goods damaged in transit. Refer to Maxtec Return Policy available on the Internet: www.maxtec.com.

5. Confirm the flow of air and/or oxygen mixture to the patient. 6. Confirm the concentration of air/oxygen with an Oxygen Analyzer/Monitor. If necessary activate bleed flow valve to maintain FIO2 accuracy. 7. To activate the bleed, slide the knurled collar back until it contacts the cover. 8. To deactivate the bleed, pull the collar away from the cover until bleed flow valve is closed. 9. Turn “OFF” gas supplies when Air-Oxygen Blender is not in use.

TROUBLESHOOTING

If the Air-Oxygen Blender fails to function, consult the Troubleshooting Guide below. If problem cannot be solved by using Troubleshooting Guide, refer to the Air-Oxygen Blender Service Manual (P/N R203M15) available on the Internet; www.maxtec.com or consult your Provider.

CLEANING CAUTION DO NOT steam autoclave. DO NOT immerse the Air-Oxygen Blender into any liquid. DO NOT use any strong solvent or abrasive cleaners. DO NOT gas sterilize with (EtO) Ethylene Oxide. DO NOT clean with aromatic hydrocarbons. DO NOT allow the liquid to penetrate the device.

PROBLEM

PROBABLE CAUSE

REMEDY

Oxygen concentration discrepancy between Blender setting and Analyzer/ Monitor (greater than 3%)

1. High Flow model, flow requirement below 15 l/min. Low Flow model, flow requirement below 3 l/min. 2. Analyzer/Monitor inaccurate 3. Low flow bleed obstructed 4. Gas supply contaminated 5. Downstream device causing back flow or restricted flow

1. Use auxiliary outlet & engage bleed 2. Recalibrate Analyzer/ Monitor or Verify with second Analyzer/Monitor 3. Remove obstruction 4. Check gas sources with calibrated Oxygen Analyzer/ Monitor to confirm Oxygen is 100% and Air is 21% 5. Isolate Blender. Check oxygen concentration at Blender Outlets

No flow at Blender outlets

1. Gas sources turned “OFF” 2. Gas sources not connected

1. Turn gas sources “ON” 2. Connect gas sources

DO NOT gas or heat sterilize. 1. Disconnect all gas connections and equipment before cleaning. 2. Close Bleed Valve to ensure O-Ring is not exposed. 3. Clean exterior surfaces using Super Sani-Cloth germicidal disposable wipes. Remove all visible contamination from the external surfaces of the device and its accessories. Be sure to closely inspect and remove contamination from seams and recesses on the device that may trap contaminants. Wipe with clean paper towel to remove debris. 4. After all visible contamination is removed; use a second germicidal wipe to thoroughly wet the surfaces of the device and accessories. Allow to remain wet for 4 minutes. Use additional wipes if needed to assure surfaces are wetted continuously for 4 minutes. 5. Allow device to air dry completely. 6. Visually inspect the device for visible contamination. Repeat cleaning/disinfection process if necessary.

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Alarm sounding Difference between Oxygen and air inlet pressures greater than specified

Correct pressure difference until Air and Oxygen pressures are within specification

DISPOSAL INSTRUCTIONS

This device and its packaging contain no hazardous materials. No special precautions need to be taken when disposing the device and/or its packaging. Please Recycle.

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