Ultra Max O2 Operating Manual & Instructions for Use

Maxtec 6526 South Cottonwood Street Salt Lake City, Utah 84107 USA Authorized Representative: QNET BV Hommerterweg 286 6436 AM Amstenrade The Netherlands

TEL: (800) 748.5355 FAX: (801) 270.5590 EMAIL: sales@maxtecinc.com WEBSITE: www.maxtecinc.com

EC REP

NOTE: The UltraMaxO2 is for use only by trained personnel. Before use, all individuals using the UltraMaxO2 should become familiar with the information contained in this Operation Manual. Adherence to these instructions is necessary for safe, effective product performance. Thoroughly read all instructions and labeling provided with this device and any other equipment that will be used.

CLASSIFICATIONS: Classification:... Class II electrical device Protection against electric shock: ... Internally powered equipment Protection against water:... IPX1 Mode of operation: ... Continuous Sterilization: ... See section 6.0 Flammable anaesthetic mixture:... Not for use in presence of flammable anaesthetic mixtures Power specification: ... 1.8-3.2V 32mW10mA Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed healthcare practitioner. Product Disposal Instructions: The batteries and circuit board are not suitable for regular trash disposal. Follow local guidelines for proper disposal

INDICATIONS FOR USE: The UltraMaxO2 is an oxygen analyzer for checking the oxygen concentration, flow and outlet pressure of oxygen concentrators.

WARRANTY: Under normal operating conditions, Maxtec warrants the UltraMaxO2 to be free from defects of workmanship or materials for a period of Three (3) years from the date of shipment from Maxtec, provided that the unit is properly operated and maintained in accordance with Maxtec’s operating instructions. Based on Maxtec product evaluation, Maxtec’s sole obligation under the foregoing warranty is limited to making replacements, repairs, or issuing credit for equipment found to be defective. This warranty extends only to the buyer purchasing the equipment directly from Maxtec or through Maxtec’s designated distributors and agents as new equipment. Routine maintenance items, such as batteries, are excluded from warranty. Maxtec and any other subsidiaries shall not be liable to the purchaser or other persons for incidental or consequential damages or equipment that has been subject to abuse, misuse, mis-application, alteration, negligence or accident. These warranties are exclusive and in lieu of all other warranties, expressed or implied, including warranty of merchantability and fitness for a particular purpose.

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PRINCIPLE OF OPERATION: The UltraMaxO2 Oxygen Analyzer measures oxygen concentration and flow using ultrasound technology and measures pressure using a piezoresistive silicon pressure sensor.

WARNINGS:

!

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

Not for use in an MRI environment.

•

Improper use of the UltraMaxO2 can cause inaccurate oxygen readings leading to improper treatment and/or patient harm. Follow the procedures outlined in this user manual.

•

The UltraMaxO2 is for checking oxygen concentrators only.

•

DO NOT use the UltraMaxO2 for continuous oxygen monitoring.

•

DO NOT use the UltraMaxO2 to measure the oxygen concentration of a concentrator when flowing at rates lower than its optimal performance as specified by the concentrator manufacturer; generally 4 LPM or less on concentrators that have a maximum flow of 10 LPM, and 1 LPM or less on concentrators that have a maximum flow of 5 LPM.

•

Not for use in anesthesia applications or for measuring oxygen concentration from any sources other than conventional oxygen concentrators.

•

Not for use with inhalation agents. Operating the UltraMaxO2 in flammable or explosive environments may result in fire or explosion.

•

Not suitable for use in the presence of flammable anesthetic mixtures.

•

Users must become thoroughly familiar with the information contained in this Operation Manual before use. Strict adherence to the operating instructions is necessary for safe, effective product performance. This product will perform only as designed if operated in accordance with the manufacturer’s operating instructions.

•

Use only genuine Maxtec accessories. Failure to do so may seriously impair the performance of the UltraMaxO2. Repair or alteration of the UltraMaxO2 by anyone other than an authorized Maxtec service representative could cause the product to fail to perform as designed.

•

Use of the UltraMaxO2 near devices that generate electrical fields may cause erratic readings.

•

If the UltraMaxO2 is ever exposed to liquids from spills or immersion, immediately remove the batteries and let the device dry completely. When dry, replace the batteries and check for proper operation.

•

DO NOT autoclave or expose the UltraMaxO2 to high temperatures (>60°C).

•

DO NOT use ethylene oxide sterilization. performance in flow and pressure readings.

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DO NOT expose the UltraMaxO2 to irradiation, vacuum, steam, or harsh chemicals.

•

DO NOT expose the UltraMaxO2 to pressure greater than 50 psi. Exposure to pressure above 50 psi could cause leaks in the device which may adversely affect

CAUTIONS: Indicates a potentially hazardous situation, if not avoided, could result in minor or moderate injury and property damage. •

Replace the batteries with high quality AA Alkaline or Lithium batteries. DO NOT use rechargeable batteries.

•

When not in use for periods greater than 30 days remove the batteries to protect the UltraMaxO2 from potential battery leakage.

•

Avoid dropping the UltraMaxO2 to prevent damage which may adversely affect its performance. If damage to the device is suspected, perform the calibration verification procedure in Section 2.3 of this operating manual.

•

Avoid foreign matter entry into the UltraMaxO2.

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TABLE OF CONTENTS Classifications... I Indications for Use... I Warranty... I Principle of Operation... II Warnings... II Cautions ... III 1.0 SYSTEM OVERVIEW ... 1 1.1 Description ... 1 1.2 Component Identification... 1 1.3 Symbol Guide ... 2 1.4 Component Description... 2 2.0 OPERATING INSTRUCTIONS... 3 2.1 Oxygen, Flow and Pressure Measurement ... 3 2.2 Switching Pressure Units of Measure... 3 2.3 Calibration Verification Procedure... 3 3.0 FACTORS INFLUENCING ACCURATE READINGS ... 4 3.1 Effects of Temperature... 4 3.2 Effects of Humidity... 4 3.3 Effects of Other Gases... 4 3.4 Effects of Low Flow ... 4 4.0 ERROR CODES ... 4 5.0 CHANGING THE BATTERIES... 5 6.0 CLEANING AND MAINTENANCE ... 5 6.1 Cleaning ... 5 6.2 Maintenance... 5 7.0 SPECIFICATIONS... 6 8.0 SPARE PARTS AND ACCESSORIES... 7 8.1 Included with your Unit... 7 8.2 Optional Accessories... 7

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1.0 SYSTEM OVERVIEW 1.1 Description & Priciple of Operation The UltraMaxO2 is an oxygen analyzer designed to check the oxygen concentration, flow and outlet pressure of oxygen concentrators. The UltraMaxO2 provides unparalleled performance and reliability from its advanced design that includes the following features and operational benefits: • • • • • • • • • • •

Accurate oxygen measurements. No in-field calibration required. Convenient ability to measure pressure in PSI or kPa. Durable, compact design. Large, easy-to-read, liquid crystal display (LCD). Shielded, reinforced sample gas inlet port. Long battery life with 2 AA batteries. Auto-off after 4 minutes. Low battery indication. Self-diagnostics. Easy to clean.

1.2 Component Identification 4

1

2

5

3

6

1

LCD Display

4

Gas Sample Inlet

2

Mode Button

5

Gas Sample Outlet

3

ON/OFF Button

6

Battery Door

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1.3 Symbol Guide The following symbols and safety labels are found on the UltraMaxO2:

!

Attention, consult accompanying documents

On/off button

Authorized representative in the European Community

Mode button

EC REP

IPX1

Do not throw away. Follow local guidelines for disposal

BAT

Low battery

Evaluated by ETL (Intertek Testing Laboratories)

LPM

Liter per minute flow

Manufacturer

PSI

Pounds per square inch

Ingress protection

kPa

Kilopascals

%

Percent

only Restricted to sale by or on order of a medical professional LATEX

Latex free

Gas sample inlet

SN

Serial number

Gas sample outlet

REF

Catalog number

Direct current

Consult accompanying documents

1.4 Component Description 3 1/2 Digit Display - The LCD provides direct readout of oxygen concentration, gas flow and gas pressure. The LCD also displays error codes as necessary. ON/OFF Button - Turns the device on or off. Mode Button - Switches between measuring the concentration of gas produced by an oxygen concentrator and pure oxygen (for calibration verification). Low Battery Indicator – Indicates the voltage of the batteries is below normal operating levels. LPM – Illuminated next to the flow measurement. (Not shown when in calibration verification mode). KPA – Indicates the pressure measurement is in units of kilopascals. PSI – Indicates the pressure measurement is in units of pounds per square inch.

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“%” symbol – Illuminated next to the concentration measurement. Gas Sample Inlet – Used to receive the gas sample. Gas Sample Outlet – Used as an outlet for the gas sample and as a trigger for pressure measurement when occluded. Gas Sample Tubing – Used to connect to gas sample sources.

2.0 OPERATING INSTRUCTIONS 2.1 Oxygen, Flow and Pressure Measurement To check oxygen concentration, flow and pressure of a gas sample from a concentrator: 1. 2. 3.

4. 5. 6. 7.

Connect the gas sample tubing to the gas sample inlet of the UltraMaxO2. Attach the other end of the gas sample tubing to the oxygen concentrator. Initiate the flow of gas to the UltraMaxO2 at a rate of 1-10 liters per minute (2 liters per minute is recommended). Ensure the concentrator’s output is stable per the concentrator manufacturer’s recommendations. Turn on the UltraMaxO2. Allow the oxygen reading to stabilize for approximately 10 seconds before reading the oxygen concentration and flow. To check pressure, cover the gas sample outlet with thumb or finger while gas is flowing. Wait 5 seconds for the display to read pressure.

2.2 Switching Pressure Units of Measure The UltraMaxO2 can measure pressure in PSI or kPa. The UltraMaxO2 is factory set to measure in PSI. To switch to kPa: 1. 2. 3.

Using a #1 Phillips screwdriver loosen the battery door screw and remove the battery door. Toggle the switch inside the battery compartment. Replace the battery door and tighten the battery door screw.

2.3 Calibration Verification Procedure A calibration verification mode is provided to verify that the UltraMaxO2 is functioning properly. To perform the calibration verification: 1. 2. 3. 4.

Turn on the UltraMaxO2. Connect a source of pure oxygen (≥99.95%) to the gas sample inlet. Flow 2-5 LPM of gas into the UltraMaxO2. Ensure that the gas flowing to the UltraMaxO2 is at a stable temperature. Press and hold the mode button. While holding the mode button, the gas measurement should read between 98.5 and 101.5% oxygen. If the gas measurement is not within this range, call Customer Service. Calibration verification mode is indicated by “CAL” and “VER” flashing on screen beneath the gas measurement .

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3.0 FACTORS INFLUENCING ACCURATE READINGS 3.1 Effects of Temperature The UltraMaxO2 compensates for temperature and will perform within specifications throughout the operating temperature range. However, taking measurements during rapid changes in gas temperature should be avoided.

3.2 Effects of Humidity The UltraMaxO2 has a humidity sensor to detect and compensate for the humidity of gas entering the device. However, high levels (condensing) of humidity can affect the accuracy and reliability of the UltraMaxO2. To prevent possible damage: • • •

Avoid usage in environments of greater than 95% relative humidity. DO NOT use this device in a breathing circuit. DO NOT breathe or blow into the UltraMaxO2.

3.3 Effects of Other Gases The UltraMaxO2 is designed to measure two different types of gas mixtures: • •

Oxygen, nitrogen and argon from oxygen concentrators. Pure oxygen during calibration verification mode.

Any other concentrations or combinations of gases will cause the UltraMaxO2 to measure oxygen concentration incorrectly.

3.4 Effects of Low Flow Oxygen concentrators function on the principle of removing nitrogen gas from air, leaving concentrated oxygen and argon at a specific oxygen to argon ratio. This operating principle may be altered when concentrators are set to flow at the low end of their operational range. At low flows they may output a low oxygen concentration, e.g. 85% to 91%, for reasons other than high nitrogen, possibly due to an increase in argon content. The UltraMaxO2 requires that the ratio of oxygen to argon remain constant in order to guarantee an accuracy of +/-1.5% oxygen. •

DO NOT use the UltraMaxO2 to measure the oxygen concentration of a concentrator when flowing at rates lower than its optimal performance as specified by the concentrator manufacturer; generally 4 LPM or less on concentrators that have a maximum flow of 10 LPM, and 1 LPM or less on concentrators that have a maximum flow of 5 LPM.

4.0 ERROR CODES

The UltraMaxO2 has self diagnostic features built into the software to detect faulty readings outside of normal operating ranges. The codes, descriptions and recommended actions are: •

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E01: Oxygen measurement out of range Hi (≥102.0% calculated by algorithm). Recommended Action: Verify that the UltraMaxO2 is being used in the correct mode (Concentrator or Calibration Verification mode). If error code repeats; perform a calibration verification per section 2.3 of this manual. If error code repeats again; contact Customer Service.

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E02: Oxygen measurement out of range Low (≤-2.0% calculated by algorithm). Recommended Action: Verify that the UltraMaxO2 is being used in the correct mode (Concentrator or Calibration Verification mode). If error code repeats; perform a calibration verification per section 2.3 of this manual. If error code repeats again; contact Customer Service.

•

E03: Device memory corrupt or missing. Recommended Action: Return the UltraMaxO2 to the manufacturer for factory repair.

•

E04: Signal reading not stable. Recommended Action: Return the UltraMaxO2 to the manufacturer for factory repair.

•

E05: Pressure measurement out of Range Hi (≥50 PSI). Recommended Action: Check the pressure on a known gas source pressure. If error code repeats; contact Customer Service.

•

E06: Outside of operating temperature Hi (≥40° C). Recommended action: The UltraMaxO2 is too hot, cool the device closer to room temperature before use.

•

E07: Outside of operating temperature Low (≤15° C). Recommended action: The UltraMaxO2 is too cold, warm the device closer to room temperature before use.

•

E08: Device self check found error. Recommended Action: Remove and replace the batteries. If error code repeats; return the UltraMaxO2 to the manufacturer for factory repair.

5.0 CHANGING THE BATTERIES Batteries should be changed when the battery icon illuminates. The battery icon will remain lit until the batteries are changed. If the battery power level is too low the UltraMaxO2 will not power on until the batteries are changed.

5.1 Battery Replacement Procedure 1. 2. 3. 4. 5.

Using a #1 Phillips screwdriver loosen the battery door screw and remove the battery door. Remove the batteries. Insert new batteries ensuring correct placement. DO NOT use rechargeable batteries. Replace the battery door and tighten the battery door screw. If the UltraMaxO2 does not power on when done verify the batteries are installed correctly and that the batteries are fresh.

6.0 CLEANING AND MAINTENANCE • • •

Use caution to prevent any fluid from entering the UltraMaxO2. DO NOT soak or immerse the UltraMaxO2 in fluid. DO NOT autoclave or expose the UltraMaxO2 to ethylene oxide sterilization.

6.1 Cleaning • Wipe down the exterior surfaces of the UltraMaxO2 with a moist cloth and mild hand or dish soap (pH 6-8).

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6.2 Maintenance Replace the batteries with high quality AA Alkaline or Lithium batteries. DO NOT use rechargeable batteries. • When not in use for periods greater than 30 days, remove the batteries to protect the UltraMaxO2 from potential battery leakage. • Store the UltraMaxO2 between -15˚C and 60˚C (5˚F - 140˚F)

7.0 SPECIFICATIONS OXYGEN Oxygen Measurement Range: (from a concentrator)

20.9 - 96%

Oxygen Measurement Accuracy:

±1.5 % of full scale at constant temperature and optimal flow*

Oxygen Measurement Resolution:

0.1% Oxygen

FLOW Flow Measurement Range:

0 - 10 LPM

Flow Measurement Accuracy:

±0.2 LPM

Flow Measurement Resolution:

0.1 LPM

PRESSURE

PSI

kPa

Pressure Measurement Range:

0.5 - 50

3.4 - 344

Pressure Measurement Accuracy:

±0.5%

±0.5%

Pressure Measurement Resolution:

0.1

0.1 up to 199, 1 from 200 to 344

Response Time:

≤17 seconds

Warm-up Time:

< 1 second

Operating Temperature:

15˚C - 40˚C (59˚F-104˚F)

Storage Temperature:

-15˚C - 60˚C (5˚F-140˚F)

Pressure:

800 - 1000 mBars

Humidity:

0 - 95% (non-condensing)

Power Requirements:

2 AA Alkaline batteries (2 x 1.5 Volts)

Battery Life:

≥ 1,100 hours (16,500 read cycles)

Low Battery Indication:

"Low Battery" icon displayed on LCD

Dimensions:

3.16” x 5.10” x 1.04” [80.3mm x 129.5mm x 26.4mm]

Weight:

0.4 lbs (181 g)

*See section 3.4 (pg. 4) of this operating manual for information on the effects of low flow.

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8.0 SPARE PARTS AND ACCESSORIES 8.1 Included with Your Unit Part Number:

Item:

R211M11 RP46P11-003

Operating Manual and Instructions for Use* Gas Sample Tubing

8.2 Optional Accessories Part Number:

Item:

R221P15

Soft Cover

* An electronic version of this Operating Manual and Instructions for Use are available on-line at www.maxtecinc.com.

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