maxtec R221M11 UltraMaxO2 Oxygen Analyzer
SYMBOL GUIDE
The following symbols and safety labels are found on the UltraMax O2:
SYSTEM OVERVIEW
Description & Principle of Operation
The UltraMax O2 is an oxygen analyzer designed to check the oxygen concentration, flow and outlet pressure of oxygen concentrators. The UltraMax O2 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.
Indications for Use
The UltraMax O2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure of an oxygen concentrator. The UltraMax O2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
Essential Device Performance
Essential performance is the operating characteristics of the device, without which would result in an unacceptable risk. The following items are considered essential performance:
- Oxygen measurement accuracy maintained within specification, ±1.5%
Component Identification 
- 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.
- MODE BUTTON — Switches between measuring the concentration of gas produced by an oxygen concentrator and pure oxygen (for calibration verification).
- ON/OFF BUTTON — Turns the device on or off.
- PSI — Indicates the pressure measurement is in units of pounds per square inch.
- KPA — Indicates the pressure measurement is in units of kilopascals.
- GAS SAMPLE INLET — Used to receive the gas sample. 7% SYMBOL — This is the port at which the device is connected to deter mine oxygen 3 ON/OFF BUTTON — Turns the device on or off. 4 PSI — Indicates the pressure measurement is in units of pounds per square inch. 5 KPA — Indicates the pressure measurement is in units of kilopascals.
- GAS SAMPLE INLET — Used to receive the gas sample. 7 % SYMBOL — This is the port at which the device is connected to deter mine oxygen concentration.
- 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).
- GAS SAMPLE OUTLET— Used as an outlet for the gas sample and as a trigger for pressure measurement when occluded.
- BATTERY DOOR GAS SAMPLE TUBING — Used to connect to gas sample sources (not shown).
OPERATING INSTRUCTIONS
Oxygen, Flow and Pressure Measurement
To check oxygen concentration, flow and pressure of a gas sample from a concentrator:
- 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.
DO NOT hold the mode button while checking a concentrator or the reading will be inaccurate.
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:
- 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.
Calibration Verification Procedure
A calibration verification mode is provided to verify that the UltraMax O2 is functioning properly. To perform the calibration verification:
- Turn on the UltraMax O2.
- Connect a source of pure oxygen (≥99.95%) to the gas sample inlet.
- Flow 2-5 LPM of gas into the UltraMax O2. Ensure that the gas flowing to the UltraMax O2 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 Maxtec Customer Service. Calibration verification mode is indicated by “CAL” and “VER” flashing on screen beneath the gas measurement.
FACTORS INFLUENCING ACCURATE READINGS
Effects of Temperature
The UltraMax O2 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.
Effects of Humidity
The UltraMax O2 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 reli-ability of the UltraMax O2. 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.
Effects of Other Gases
The UltraMax O2 is designed to measure two different types of gas mixtures:
Any other concentrations or combinations of gases will cause the UltraMax O2 to measure oxygen concentration incorrectly.
Effects of Low Flow
Oxygen concentrators function on the principle of removing nitrogen gas from air, leaving con-centrated 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 ni-trogen, possibly due to an increase in argon content. The UltraMax O2 requires that the ratio of oxygen to argon remain constant in order to guarantee an accuracy of +/-1.5% oxygen.
- DO NOT use the UltraMax O2 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.
ERROR CODES
The UltraMax O2 has self diagnostic features built into the software to detect faulty readings outside of normal operating ranges. The codes, descriptions and recommended actions are:
- E01: Oxygen measurement out of range Hi (≥102.0% calculated by algorithm).
Recommended Action: Verify that the UltraMax O2 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 Maxtec Customer Service. - E02: Oxygen measurement out of range Low (?-2.0% calculated by algorithm).
Recommended Action: Verify that the UltraMax O2 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 Maxtec Customer Service. - E03: Device memory corrupt or missing.
Recommended Action: Return the UltraMax O2 to the manufacturer for factory repair. - E04: Signal reading not stable.
Recommended Action: Return the UltraMax O2 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 Maxtec Customer Service. - E06: Outside of operating temperature Hi (≥40° C).
Recommended Action: The UltraMax O2 is too hot, cool the device closer to room temperature before use. - E07: Outside of operating temperature Low (?15° C).
Recommended Action: The UltraMax O2 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 UtraMax O2 to the manufacturer for factory repair.
CHANGING THE BATTERIES
Batteries should be changed by service personnel. Use only brand name batteries. Replace with two AA batteries and insert per orientation marked on the device. Batteries should be changed when the icon illuminates. The 
icon will remain lit until the batteries are changed. If the battery power level is too low the UltraMax O2 will not power on until the batteries are changed.
Battery Replacement Procedure
- Using a #1 Phillips screwdriver loosen the battery door screw and remove the battery door.
- Remove the batteries.
- Insert new batteries ensuring correct polarity.
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.
CLEANING AND MAINTENANCE
If you suspect any other surfaces of the device have become contaminated, follow the cleaning instructions. Cleaning should be performed on an as needed basis as the device does not directly contact the patient, bodily fluids, or expired gases in normal use.
- DO NOT soak or immerse the UltraMaxO2 in fluid.
- DO NOT autoclave or expose the UltraMaxO2 to ethylene oxide sterilization.
- DO NOT attempt to clean, or service UltraMaxO2 while device is in use.
Cleaning
Wipe down the exterior surfaces of the UltraMaxO2 with a moist cloth and mild hand or dish soap (pH 6-8).
Maintenance
Replace the batteries with high quality AA Alkaline 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).
SPECIFICATIONS
- Response Time ………………………………………………………………………………………………….. ?17 seconds
- Operating Temperature …………………………………………………………………….. 15°C – 40°C (59°F – 104°F)
- Storage Temperature ………………………………………………………………………… -15°C – 60°C (5°F – 140°F)
- Pressure ……………………………………………………………………………………………………… .. 800-1100 mBars
- Humidity………………………………………………………………………………………. ..0-95% (non-condensing)
- Power Requirements ………………………………………………………. 2 AA Alkaline batteries (2 x 1.5 Volts)
- Battery Life ………………………………………………………………………………………………………. ≥ 1,100 hours
- 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 (181g)
- Expected Service Life …………………………………………………………………………………………………… 5 Years
- Voltage and Wattage Rating ……………………………………………………………… 3V
6mW
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
- Pressure Measurement Range …………………………………………………….. 0.5 – 50 (PSI), 3.4 – 344 (kPa)
- Pressure Measurement Accuracy ……………………………………………………….. ±0.5% (PSI), ±0.5% (kPa)
- Pressure Measurement Resolution ……………………. 0.1 (PSI), 0.1 up to 199, 1 from 200 to 344 (kPa)
- Storage Temperature Limits to
Operational Use
- Cool-Down time ………………………………………………………………………………………………………. 5 Minutes
- Warm-Up time ……………………………………………………………………………………………………….20 Minutes
SPARE PARTS AND ACCESSORIES
Included With Your Unit
| PART NUMBER | ITEM | EXPECTED SERVICE LIFE |
| R221M11 | Operating Manual and Instructions for Use* | N/A |
| R100P91-001 | Gas Sample Tubing | Life of UltraMaxO2 |
| R221P15 | Soft Cover | Life of UltraMaxO2 |
Repair of this equipment must be performed by a qualified service technician experienced in repair of portable hand held medical equipment.
Equipment in need of repair shall be sent to:
Maxtec
Customer Service Department
2305 South 1070 West Salt Lake City, Ut 84119
(Include RMA number issued by Customer Service)
ELECTROMAGNETIC COMPATIBILITY
The UltraMaxO2 is suitable for the electromagnetic environment of typical hospital and home healthcare settings. The user should assure that it is used in such an environment.
During the immunity testing described below, the UltraMaxO2 will analyze oxygen concentration within specification.
- WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the UltraMaxO2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
- WARNING: The UltraMaxO2 should not be used adjacent to or stacked with other equip-ment. If adjacent or stacked use is necessary, the UltraMaxO2 should be observed to verify normal operation. If operation is not normal, the UltraMaxO2 or the equipment should be moved.
- WARNING: Use of accessories, transducers and cables other than those specified or pro-vided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
- WARNING: Avoid exposure to known sources EMI (electromagnetic interference) such as diathermy, lithotripsy, electrocautery, RFI (Radio Frequency Identification), and electromagnetic security systems such as anti-theft/electronic article surveillance systems, metal de-tectors. Note that the presence RFID devices may not be obvious. If such interference is suspected, reposition the equipment, if possible, to maximize distances.
| ELECTROMAGNETIC EMISSIONS | ||
| This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment. | ||
| EMISSIONS | COMPLIANCE ACCORDING TO | ELECTROMAGNETIC ENVIRONMENT |
| RF Emissions (CISPR 11) | Group 1 | The UltraMaxO2 uses RF energy only for its inter- nal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| CISPR Emissions Classification | Class B | The UltraMaxO2 is suitable for use in environments of typical hospital and home healthcare settings. |
| Harmonic Emissions (IEC 61000-3-2) | N/A | |
| Voltage Fluctuations (IEC 61000-3-3) | N/A | |
The UltraMax O2 was also tested for radiated immunity to RF wireless communication equipment at the test levels below
| Frequency (HZ) | Modulation | Level V/m |
| 385 | PULSE, 18 Hz, 50% DC | 27 |
| 450 | FM, 1 kHz Sine, ±5 Hz Deviation | 28 |
| 710, 745, 780 | PULSE, 217 Hz, 50% DC | 9 |
| 810, 870, 930 | PULSE, 18 Hz, 50% DC | 28 |
| 1720, 1845, 1970 | PULSE, 217 Hz, 50% DC | 28 |
| 2450 | 28 | |
| 5240, 5500, 5785 | 9 |
| ELECTROMAGNETIC IMMUNITY | ||||
| This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment. | ||||
| IMMUNITY | IEC 60601-1-2: TEST LEVEL | ELECTROMAGNETIC | ||
| AGAINST | ENVIRONMENT | |||
| Professional | Home | |||
| Healthcare | Healthcare | |||
| Facility Environment | Environment | |||
| Electrostatic discharge,ESD (IEC 61000-4-2) | Contact discharge: ±8 kV Air discharge: ±2 kV,±4 kV, ±8 kV, ±15 kV | Floors should be wood, concrete, or ceramic tile.If floors are covered with synthetic material, the relative humidity should be kept at levels to reduce electrostaticcharge to suitable levels. | ||
| Electrical fast transients / bursts (IEC 61000-4-4) | N/A | |||
| Surges on AC mains lines (IEC 61000-4-5) | ||||
| N/A | Equipment which emits high levels of power line magnetic fields (in excess of 30A/m) should be kept at a distance to reduce the likelihood ofinterference. | |||
| Power frequency magnetic field 50/60 Hz(IEC 61000-4-8) | 30 A/m50 Hz or 60 Hz | |||
| Voltage dips and short interruptions on AC mainsInput lines(IEC 61000-4-11) | ||||
| N/A | ||||
| Conducted RF coupled into lines (IEC 61000-4-6) | N/A | N/A | ||
| Radiated RF immunity(IEC 61000-4-3) | 3 V/m | 10 V/m | ||
| 80 MHz – 2,7 GHz80% @ 1 KHzAM Modulation | 80 MHz – 2,7 GHz80% @ 1 KHzAM Modulation | |||
| Radiated fields to close proximity (IEC 61000-4-39) | 8 A/m at 30 kHz (CW Modulation)65 A/m at 134.2 kHz(2.1 kHz PM, 50% duty cycle)7.5 A/m at 13.56 MHz(50 kHz PM, 50% duty cycle) | Avoid exposure to known sources of EMI (electromagnetic interference) such as diathermy, lithotripsy, electrocautery, RFID (Radio Frequency Identification), and electromagnetic security systems, metal detectors. Note that the presence of RFID devices may not be obvious. If such interference is suspected, reposition the equipment, if possible, to maximize distances. |
||
2305 South 1070 West Salt Lake City, Utah 84119 800-748-5355 www.maxtec.com
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
- The latest edition of this operating manual can be downloaded from our website at: www.maxtec.com
- EMERGO EUROPE Westervoortsedijk 60, 6827 AT Arnhem The Netherlands
- Conforms to: ANSI/AAMI STD ES60601-1 IEC STDS 60601-1-6 & 60601-1-11
- Certified to: CSA STD C22.2 No. 60601-1
NOTE: The UltraMax O2 is for use only by trained personnel. Before use, all individuals using the UltraMax O2 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.
CLASSIFICATION
- Protection against electric shock ……………………………………………….Internally Powered Equipment
- Protection against water …………………………………………………………………………………………………. IP22
- Mode of operation ……………………………………………………………………………………………….. Continuous
- Sterilization ………………………………………………………………………………………………………. See section 6
- Flammable anesthetic mixture ……….. Not for use in presence of flammable anesthetic mixtures
- Applied Parts …………………………………………………………………………………………………………………… N/A
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 UltraMaxO2 and batteries are not suitable for regular trash disposal. Dispose of device and batteries according to local guidelines.
WARRANTY
Under normal operating conditions, Maxtec warrants the UltraMax O2 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.
PRINCIPLE OF OPERATION
The UltraMax O2 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 UltraMax O2 in flammable or explosive environments may result in fire or explosion.
- NOT SUITABLE for use in the presence of flammable anesthetic mixtures.
- Oxygen rapidly accelerates combustion.
- DO NOT smoke while using the UltraMax O2 for checking oxygen concentrators.
- 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 UltraMax O2. Repair or alteration of the UltraMax O2 by anyone other than an authorized Maxtec service representative could cause the product to fail to perform as designed.
- Use of the UltraMax O2 near devices that generate electrical fields may cause erratic readings.
- If the UltraMax O2 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.
- 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 performance in flow and pressure readings.
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 batteries.
- DO NOT use rechargeable batteries.
- When not in use for periods greater than 30 days remove the batteries to protect the UltraMax O2 from potential battery leakage.
- Avoid dropping the UltraMax O2 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 UltraMax O2.
- DO NOT use the UltraMaxO2 to check a concentrator with a humidifier in place. Humidity from a humidifier could damage the device.
- DO NOT check a concentrator while holding the mode button or the reading will be inaccurate.
- Following storage in extremely hot or cold conditions, allow the gas to flow through the analyzer long enough for the internal sensors to reach the gas stream temperature, or wait for the analyzer to equilibrate to room temperature before use.
- Product is not made with natural rubber.
NOTE: SERIOUS incident(s) that occur in relation to the device should be reported to Maxtec and the competent authority of the Member State in which the user and/or patient is established. Serious incident(s) is defined as directly or indirectly le, might have led, or might lead to the death of a patient, user, or other person: the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health; or a serious public health threat.
Frequently Asked Questions
- Q: Can I use rechargeable batteries with the UltraMaxO2?
A: No, only high-quality AA Alkaline batteries should be used with the UltraMaxO2. Rechargeable batteries are not recommended. - Q: What should I do if I suspect damage to the device?
A: If damage is suspected, perform the calibration verification procedure as outlined in Section 2.3 of the Operation Manual to ensure accurate readings. - Q: Can I use the UltraMaxO2 in an MRI environment?
A: No, the UltraMaxO2 should not be used in an MRI environment. It is not designed for such conditions.
Documents / Resources
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maxtec R221M11 UltraMaxO2 Oxygen Analyzer [pdf] Instruction Manual R221M11, R221M11 UltraMaxO2 Oxygen Analyzer, UltraMaxO2 Oxygen Analyzer, Oxygen Analyzer, Analyzer |