MiniOX® 3000
Oxygen Monitor
Operation Manual
W WARNING
THIS MANUAL MUST BE READ CAREFULLY PRIOR TO THE OPERATION OF THIS DEVICE. THIS DEVICE WILL PERFORM AS DESIGNED ONLY IF USED IN ACCORDANCE WITH THE MANUFACTURER’S INSTRUCTIONS. IMPROPER USE MAY CAUSE THE DEVICE TO FAIL TO PERFORM AS DESIGNED AND MAY CAUSE INJURY TO THE PATIENT AND/OR HEALTHCARE PROFESSIONAL.
The warranties made by Ohio Medical Corporation® with respect to these products are voided if the products are not installed, used and serviced in accordance with the instructions in this manual. Please protect yourself and your patients by following them. We encourage our customers to write or call regarding this equipment prior to use or for any additional information relative to use or repairs.
This product is not intended as a life-sustaining or life-supporting device.
FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SELL BY OR ON THE ORDER OF A PHYSICIAN
Ohio Medical Corporation® | 1111 Lakeside Drive | Gurnee, IL 60031 USA 1-866-549-6446 | fax: 1-847-855-6218 | www.ohiomedical.com
P/N 814358 [Rev.1] 09/2010
P/N 814358 [Rev.1] 09/2010
Ohio Medical Corporation®
Medical Instrument Warranty
This product is sold by Ohio MedicalTM under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this product directly from Ohio Medical or Ohio Medical’s Authorized Dealers as new merchandise and are extended to the first Buyer thereof, other than for purpose of resale.
For a period of twelve (12) months from the date of original delivery to Buyer, to Buyer’s order, or to an Ohio Medical Authorized Dealer, this product, other than its expendable parts, is warranted to be free from functional defects in materials and workmanship and to conform to the description of the product contained in the operation manual and accompanying labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of sixty (60) days with respect to the expendable parts. The foregoing warranties shall not apply if the product has been repaired other than by Ohio Medical or in accordance with written instructions provided by Ohio Medical, or altered by anyone other than Ohio Medical, or if the product has been subject to abuse, misuse, negligence, or accident.
Ohio Medical’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing, free of charge, at Ohio Medical’s option, a product, which is telephonically reported to the nearest Ohio Medical Regional Service Office and which, if so advised by Ohio Medical, is thereafter returned with a statement of the observed deficiency, not later than seven (7) days after the expiration date of the applicable warranty,to the designated Ohio Medical Service Office during normal business hours, transportation charges prepaid, and which, upon Ohio Medical’s examination, is found not to conform with the above warranties. Ohio Medical shall not be otherwise liable for any damages including, but not limited to incidental damages, consequential damages, or special damages.
There are no express or implied warranties which extend beyond the warranties herein above set forth. Ohio Medical makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.
P/N 814358 [Rev.1] 09/2010
MiniOX® 3000 Oxygen Monitor |
General WARNINGS and CAUTIONS |
General Warnings and Cautions
W WARNING
1. The MiniOX® 3000 Oxygen Monitor will perform to specifications only if it is used and serviced in accordance with the manufacturer’s instructions. This instrument is to be used only by qualified, trained personnel who have carefully read the operating manual and labels and who have observed the information set forth. If this instrument does not perform as described in this manual, the instrument must not be used until the condition is rectified.
2.TheMiniOX® 3000OxygenMonitormustbecalibrated prior to each use. A two point calibration check must be performed weekly. See Section 3, Operation. If the instrument cannot be calibrated, the sensor must be replaced. If the instrument is still unable to be calibrated, the instrument must be serviced.
3.The oxygen sensor has a minimal response to certain gases other than oxygen. Be aware of these gases and their interference levels. See Appendix C, Interferent Gases and Vapors.
4.The oxygen sensor is affected by changes in barometric pressure. See Appendix B, Effects of Pressure, Humidity and Temperature.
5.The sensor is a sealed unit containing a potassium hydroxide electrolyte, which is caustic. If the sensor
should develop a leak and the contents come in contact with skin or clothing, rinse area with large quantities of water. In case of eye contact, immediately flush eyes for at least 15 minutes, holding eyes open. Call a physician. Dispose of a leaking sensor immediately; it must be disposed of in accordance with all applicable federal, state, and local regulations.
6.Ensureatightfitexistsbetweenthesensorandthetee adapter. Ohio Medical tee adapters are engineered to fit securely with Ohio Medical sensors. However, the sensor retaining strap must be used to prevent accidental separation of sensor and tee adapter.
7.Never operate the MiniOX® 3000 Oxygen Monitor if it is suspected that water or other liquids have entered into the case. If this occurs, immediately turn the unit OFF and contact your nearest Ohio Medical Service Center for additional information.
8.Useofdevicesgeneratingoremittingelectromagnetic radiation near the MiniOX® 3000 Oxygen Monitor may interfere with the proper operation of the product, causing it to fail to perform as designed. Particularly, the electromagnetic radiation from the interfering device may cause the product to display incorrect/ erratic values or to stop operating. Special attention should be paid to the patient if this occurs.
9.Never use the MiniOX® 3000 Oxygen Monitor in combustible atmosphere, such as occurs with flammable anesthetics. Such use could result in ignition of atmosphere.
10.Never allow an excess length of cable near the patient’s head or neck, as such could result in strangulation. Secure excess cable to the bed rail or other suitable object.
FAILURE TO COMPLY WITH THESE WARNINGS COULD JEOPARDIZE THE WELL-BEING OF THE PATIENT AND/OR HEALTH CARE PROFESSIONAL.
W CAUTION
1.Removeinternalbatteryifunitistobenon-operational for extended periods of time.
2.Observe polarity when inserting a new battery. Incorrect connection may cause damage to the instrument.
3.The MiniOX® 3000 Oxygen Monitor must never be immersed in any cleaning solution, autoclaved, or exposed to temperatures greater than 70oC.
4.Use only genuine Ohio Medical Corporation accessories and replacement parts. Failure to do so may seriously impair the monitor’s performance. Repair or alteration of the MiniOX® 3000 Oxygen Monitor beyond the scope of the maintenance instructions or by anyone other than an authorized Ohio Medical Corporation service person could
cause the product to fail to perform as designed.
5.Improper mounting of the sensor in a breathing circuit may result in inaccurate readings. The sensor MUST be mounted with the deflector pointing downward to prevent moisture collection on the sensor membrane (see Figures 3-3 and 3-4 in Section 3, Operation). Install the sensor upstream from the humidifier to minimize its exposure to moisture.
6.Never use a MiniOX® 3000 Oxygen Monitor with a cable that appears worn, cracked, or has damaged insulation.
FAILURE TO COMPLY WITH THESE CAUTIONS COULD RESULT IN INSTRUMENT DAMAGE AND/OR FAILUREOFUNITTOPERFORMTOSPECIFICATIONS.
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P/N 814358 [Rev.1] 09/2010 |
MiniOX® 3000 Oxygen Monitor |
General WARNINGS and CAUTIONS |
Definition of Warnings and Cautions
W WARNING
WCAUTION
NOTE:
Statement citing a potential safety hazard and possible injury to yourself or others.
Statement citing a possibility of damage to the instrument or other property.
Advisory on instrument function.
P/N 814358 [Rev.1] 09/2010 |
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MiniOX® 3000 Oxygen Monitor |
Table of Contents |
Section 1 |
|
Introduction.......................................................................................... |
1-1 |
General Description.................................................................................................................. |
1-1 |
Operating Principles.................................................................................................................. |
1-2 |
MiniOX® 3000 Oxygen Sensor ............................................................................................. |
1-2 |
MiniOX® 3000 Instrument .................................................................................................... |
1-2 |
Operator Interface .............................................................................................................. |
1-2 |
Internal Functions ............................................................................................................... |
1-2 |
Data and System Status ...................................................................................................... |
1-2 |
Performance Features ............................................................................................................ |
1-2 |
Calibration............................................................................................................................. |
1-2 |
Low/High Oxygen Concentration Alarms.............................................................................. |
1-3 |
Low Battery Alarms .............................................................................................................. |
1-3 |
Sensor Indicator .................................................................................................................. |
1-3 |
Calibration Needed Indicator ............................................................................................... |
1-3 |
Error Handling ...................................................................................................................... |
1-4 |
Test Functions....................................................................................................................... |
1-4 |
Radio FrequencylElectromagnetic Insensitivity.................................................................... |
1-4 |
Section 2 |
|
Setting Up the MiniOX® 3000 Oxygen Monitor ................................ |
2-1 |
Figure 2-1 MiniOX® 3000 Oxygen Monitor....................................................................... |
2-1 |
W CAUTION................................................................................................................ |
2-2 |
Figure 2-2 Assembled MiniOX® 3000 Oxygen Monitor ................................................... |
2-2 |
Section 3 |
|
Operation.............................................................................................. |
3-1 |
Calibration................................................................................................................................. |
3-1 |
W CAUTION..................................................................................................................... |
3-1 |
To Calibrate In Room Air, Figure 3-1 ................................................................................... |
3-1 |
Figure 3-1 Calibrating the MiniOX® 3000 Oxygen Monitor in Room Air.......................... |
3-1 |
To Calibrate at 100% O2 , Figure 3-2 ................................................................................... |
3-2 |
Figure 3-2 Calibrating the MiniOX® 3000 Oxygen Monitor at 100% O2............................ |
3-2 |
Two-Point Linearity Check....................................................................................................... |
3-3 |
Setting the Alarms.................................................................................................................... |
3-3 |
To Set the Low Alarm............................................................................................................ |
3-3 |
To Set the High Alarm........................................................................................................... |
3-4 |
Alarm Conditions...................................................................................................................... |
3-4 |
High and Low Oxygen Concentration Alarms...................................................................... |
3-4 |
Silencing an Alarm................................................................................................................ |
3-4 |
Low Battery Alarms. ............................................................................................................. |
3-4 |
Sensor Indicator................................................................................................................... |
3-4 |
Error Handling....................................................................................................................... |
3-5 |
Table 3-1 Alarms and Status Messages........................................................................... |
3-5 |
Test Functions...................................................................................................................... |
3-6 |
Battery Test........................................................................................................................... |
3-6 |
High and Low Alarms Test. .................................................................................................. |
3-6 |
Installing the Sensor in a Breathing Circuit............................................................................... |
3-6 |
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MiniOX® 3000 Oxygen Monitor |
Table of Contents |
Mounting the Instrument with a Pole Bracket........................................................................... |
3-6 |
|
Figure 3-3 |
Installing Sensor into Tee Adapter ...................................................................... |
3-7 |
Figure 3-4 |
Sensor in Breathing Circuit................................................................................. |
3-8 |
Figure 3-5 |
MiniOX® 3000 Oxygen Monitor with Pole Mounting Bracket............................... |
3-8 |
Section 4 |
|
Maintenance and Care......................................................................... |
4-1 |
W CAUTION .................................................................................................................... |
4-1 |
Battery & Battery Cover Replacement...................................................................................... |
4-1 |
Figure 4-1. Battery Cover Removal ................................................................................. |
4-1 |
Sensor Replacement................................................................................................................ |
4-2 |
Deflector Replacement............................................................................................................. |
4-2 |
Cable Replacement.................................................................................................................. |
4-2 |
Cleaning, Disinfection and Sterilization..................................................................................... |
4-2 |
W CAUTION..................................................................................................................... |
4-2 |
Instrument ............................................................................................................................ |
4-2 |
Sensor and Cable ................................................................................................................ |
4-3 |
Sensor Deflector, Retaining Strap and Tee Adapter ............................................................ |
4-3 |
Appendix A |
|
Specifications.............................................................................................. |
A-1 |
Table A-1. Specifications................................................................................................... |
A-1 |
Appendix B |
|
Effects of Pressure, Humidity and Temperature ............................. |
B-1 |
W CAUTION .................................................................................................................... |
B-1 |
Effects of Pressure ................................................................................................................... |
B-1 |
W CAUTION .................................................................................................................... |
B-1 |
Effects of Humidity.................................................................................................................... |
B-1 |
Effects of Temperature ............................................................................................................. |
B-1 |
W CAUTION .................................................................................................................... |
B-1 |
W CAUTION .................................................................................................................... |
B-1 |
Appendix C |
|
Interferent Gases and Vapors............................................................ |
C-1 |
Table C-1 Interferent Gases and Vapors ........................................................................ |
C-1 |
Appendix D |
|
Troubleshooting................................................................................. |
D-1 |
Table D-1 Troubleshooting ............................................................................................. |
D-1 |
Appendix E |
|
Error Codes......................................................................................... |
E-1 |
Table E-1 Error Codes ..................................................................................................... |
E-1 |
Appendix F |
|
Accessories and Replacement Parts ................................................ |
F-1 |
Table F-1 Accessories and Replacement Parts ............................................................. |
F-1 |
P/N 814358 [Rev.1] 09/2010 |
TOC-2 |
MiniOX® 3000 Oxygen Monitor
Section 1
Introduction
The MiniOX® 3000 Oxygen Monitor provides continuous, direct monitoring of oxygen mixtures in a variety of applications, including:
•Respiratory Therapy (e.g., respirators, ventilators, pediatric incubators)
•Anesthesiology (e.g., anesthesia machines)
•Oxygen Therapy (e.g., oxygen tents)
The monitor is for use by trained health care professionals:
•under the supervision, or on the order, of a physician
•in a hospital or clinical setting
•during emergency transport
General Description
Battery-operated and microprocessor-controlled, the MiniOX® 3000 Oxygen Monitor measures oxygen concentrations in the 0% to 100% range. The monitor’s performance features ensure reliable and accurate oxygen measurement. These features include:
•calibration function
•high and low oxygen concentration alarms
•low and depleted battery alarms
•oxygen sensor indicator
•automatic error detection
•battery test
•oxygen alarm test
The calibration function allows calibration of the device against room air (defined as oxygen
concentration of 20.8%) or 100% O2. Audible and visual alarms alert the operator when monitor calibration is required.
High and low oxygen concentration alarms may be set in the ranges of:
•16% to 100% (high alarm) and
•15% to 99% (low alarm)
or the default high/low settings may be used (50% and 18%, respectively). Audible and visual alarms activate when oxygen concentrations:
Section 1, Introduction
•fall below the preset (or default) low alarm setting
•rise above the preset (or default) high alarm setting
The MiniOX® 3000 Oxygen Monitor:
•detects low and depleted battery conditions
•activates audible and visual alarms
•alarms for:
•sensor disconnection or malfunction
•various internal operating errors
The MiniOX® 3000 Oxygen Monitor conducts selfchecks:
•at power-up (battery installation)
•at turn on
•during operation
Additionally, the monitor has two operator-initiated test functions:
•The Alarm Test verifies the operation of the high and low oxygen level alarms
•The Battery Test assesses the relative remaining battery life
The MiniOX® 3000 Oxygen Monitor consists of two components: the instrument and the oxygen sensor.
The front of the hand-held instrument features:
•a touch-sensitive keypad
•a liquid crystal display (LCD) that shows:
•monitor status
•continuous oxygen concentrations
•preset alarm levels
•two red light-emitting diodes (LEDs) which serve as visual alarms
The back of the instrument case features:
•a bail bar to allow the instrument to “stand” on a horizontal surface during monitoring operations
•a plastic wedge that slides into an optional bracket for mounting the instrument on a horizontal or vertical pole
The galvanic oxygen sensor consists of a deflector assembly and a plastic housing containing two electrodes. A coiled cable connects the sensor to the
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P/N 814358 [Rev.1] 09/2010 |
MiniOX® 3000 Oxygen Monitor
instrument. Plugs at each end of the cable snap into jacks (one located in the sensor housing and one located in the instrument) and are held securely in place by twist collars.
The oxygen sensor is introduced into a breathing circuit through an Ohio Medical Corporation tee adapter connecting two lengths of tubing. The sensor/tee adapter assembly is positioned with the sensor deflector pointing downward to ensure that moisture does not collect on the sensor membrane. The retaining strap ensures that the sensor remains securely in place in the tee adapter.
See the following appendices:
•Appendix A, Specifications
•Appendix F, Accessories/Replacement Parts
Operating Principles
MiniOX® 3000 Oxygen Sensor
The oxygen sensor includes two electrodes:
•a gold cathode exposed to the atmosphere through a fluoropolymer membrane
•a lead anode submersed in a potassium hydroxide solution
When oxygen diffuses through the membrane, the electrochemical reduction of oxygen on the cathode and the corresponding oxidation on the anode generate an electrical current proportional to the partial pressure of oxygen in the sample atmosphere. The instrument temperature compensates, amplifies, and converts the electrical current, displaying O2 values.
The Ohio Medical Corporation oxygen sensor is selfzeroing; when no oxygen is present:
•no current is produced
•0% oxygen is displayed
The sensor has a minimal response to gases other than oxygen (see Appendix C, Interferent Gases and Vapors).
MiniOX® 3000 Instrument
The MiniOX® 3000 Oxygen Monitor is batterypowered and microprocessor-controlled. The microprocessor:
Section 1, Introduction
•provides the operator interface
•controls internal functions
•monitors data and system status
Operator Interface
When the operator enters commands using the keypad, the microprocessor interprets these commands and responds by:
•displaying text in the LCD
•activating the LEDs
•emitting audible tones
Internal Functions
During operation, the microprocessor coordinates all internal functions including:
•self-testing
•response to keypad commands
•data collection
•display update
•confirmation that a programmed sequence is properly followed
Data and System Status
The signal from the oxygen sensor is amplified and converted to a digital value through electronic circuitry. Following software compensation, the microprocessor:
•compares current data to preselected values
•displays the updated O2 concentration
•if appropriate, activates audible and visual alarms
The microprocessor also monitors internal systems, indicating such operating conditions as:
•calibration required
•low battery voltage
•sensor disconnect
•system error
Performance Features
Calibration
The MiniOX® 3000 Oxygen Monitor must be calibrated:
P/N 814358 [Rev.1] 09/2010 |
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MiniOX® 3000 Oxygen Monitor
•daily, while in operation
•each time the monitor is turned ON
•following sensor disconnection/reconnection
•when environmental conditions (pressure, humidity and temperature) change
When a MiniOX® 3000 Oxygen Monitor with a sensor connected is turned ON, the monitor performs a selftest and a calibration requirement occurs:
•“CAL” flashes on the display, telling the operator to carry out the calibration procedure
The calibration procedure is initiated by exposing the sensor to a calibration gas [either room air (defined as oxygen concentration of 20.8%) or 100% oxygen] and pressing the corresponding key on the keypad. The following appears on the display:
•“CAL LOCKED”
•the selected calibration gas concentration.
When the unlock key is pressed the monitor displays:
•“CAL”
•a 10-segment bar graph which “counts down” two seconds per bar for 20 seconds
The monitor automatically calibrates to the selected concentration. At the end of the 20 seconds, the monitor:
•emits a beep indicating that calibration is complete
•enters the operating mode
See Section 3, Calibration
Low/High Oxygen Concentration Alarms
The MiniOX® 3000 Oxygen Monitor has audible and visual alarms that activate when oxygen concentrations exceed preset low or high alarm settings. Default settings are 18% and 50%, respectively; however, the operator may select alarm levels between 15% and 100%. See Section 3, Setting the Alarms
When the MiniOX® 3000 Oxygen Monitor detects an oxygen concentration that exceeds the preset alarm limit:
•the red LED for that alarm flashes
Section 1, Introduction
•an audible alarm activates
•the measured concentration appears in the display
The operator can silence the audible alarm for three 30-second intervals for a total of 90 seconds; however, the visual alarm continues to flash. At the end of the silence period, the audible alarm
reactivates if the alarm condition is not corrected. See Section 3, Silencing an Alarm
Low Battery Alarms
The MiniOX® 3000 Oxygen Monitor features a twostage battery alarm that warns of depleted and expired battery voltage:
•The first alarm alerts the operator that the monitor has approximately six hours of operating time remaining:
•a warning message appears in the display
•an audible alarm sounds at 30-second intervals
•If the operator does not replace the battery after this alarm, a second low battery alarm activates when the battery is no longer able to support monitoring. The monitor:
•displays a warning message
•activates an audible and visual alarm (See Section 3, Low Battery Alarms)
Sensor Indicator
During monitoring, the MiniOX® 3000 Oxygen Monitor displays a warning message; audible and visual alarms activate if:
•the oxygen sensor becomes disconnected
•the cable fails or disconnects from the sensor or instrument
•the sensor membrane is perforated
•the thermistor circuit opens
Calibration Needed Indicator
The MiniOX® 3000 Oxygen Monitor flashes “CAL”:
•when the monitor is turned ON
•following sensor disconnection/reconnection
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P/N 814358 [Rev.1] 09/2010 |
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