Precision Medical PM5900 Oxygen Monitor User Manual

Precision Medical PM5900 Oxygen Monitor

Receiving/Inspection
Remove the Precision Medical Oxygen Monitor from the packaging and inspect for damage. If there is any damage, DO NOT USE and contact your Provider.

Intended Use
Precision Medical, Inc. Oxygen Monitor provides continuous, direct monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia machines), respiratory devices (e.g., respirators, ventilators, pediatric incubators), and oxygen therapy (e.g., oxygen tents).
Operator Profile
The oxygen monitor is to be used by trained healthcare professionals under the supervision, or on the order, of a physician in a hospital (or another clinical setting). The Precision Medical, Inc. Oxygen Monitor is not intended for transport use. This device is not an oxygen supply source.

Read All Instructions Before Using
This manual instructs a Professional to install and operate the Oxygen Monitor. This is provided for your safety and to prevent damage to the Oxygen Monitor. If you do not understand this manual, DO NOT USE the Oxygen Monitor and contact your Provider.

Safety Information

Warnings and Cautions

• DANGER Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury.
• WARNING Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
• CAUTION Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury.
• CAUTION Used without the safety alert symbol indicates a potentially hazardous situation that, if not avoided, may result in property damage.
• Direct current.
• PM5900 WITH RESPECT TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1, CAN/CSA C22.2 No. 601.1

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

WARNING

• Only trained, qualified medical personnel under the direct supervision of a licensed physician should operate the Oxygen Monitor.
• Use this Oxygen Monitor only for its intended use as described in this manual.
• Medical Oxygen should meet the requirements of USP.
• Always follow ANSI and CGA standards for Medical Gas Products, Flowmeters, and Oxygen Handling.
• The Oxygen Monitor should be serviced by a qualified hospital/dealer service technician, or by Precision Medical, Inc.
• DO NOT obstruct the alarm grill on the back of the Oxygen Monitor.
• DO NOT use near any type of flame or flammable/ explosive substances, vapors or atmosphere.
• DO NOT allow an excess length of the cable near the patient’s head or neck, this could result in strangulation. Secure excess cable to a bed rail or suitable object.
• DO NOT use Oxygen Monitor with a cable that appears worn, cracked or has damaged insulation.
• Never install the sensor in a location that will expose the sensor to the patient’s exhaled breath or secretions, unless you intend to dispose of the sensor, flow diverter, and tee adapter.
• Improper use of this device can cause inaccurate oxygen measurements
• A device is intended for use with dry gas only.
• Before use, all individuals who will be using the Oxygen Monitor must become thoroughly familiar with the information contained in this Operation Manual. Strict adherence to the operating instructions is necessary for safe, effective product performance. This product will perform only as designed if installed and operated in accordance with the manufacturer’s operating instructions.
• Use only genuine Precision Medical Inc. accessories and replacement parts. Failure to do so may seriously impair the analyzer’s performance. Repair of this equipment must be performed by a qualified service technician.
• Calibrate the Oxygen Monitor weekly when in operation, or if environmental conditions change significantly. (i.e., Elevation, Temperature, Pressure, Humidity.
• Use of the Oxygen Monitor near devices that generate electrical fields may cause erratic readings.
• Although the sensor of this device has been tested with various anesthesia gases including nitrous oxide, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane and found to have acceptably low interference, the device in entirety (including electronics) is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Only the threaded sensor face, flow diverter, and “T” adapter may be allowed to contact such a gas mixture.
• No modification of this equipment is allowed.

CAUTION

• The Oxygen Monitor contains magnetic, ferrous material that may affect the results of an MRI.
• Store the Oxygen Monitor in a clean, dry area when not in use.
• DO NOT use if dirt or contaminants are present on or around this Oxygen Monitor or connecting devices.
• DO NOT smoke in an area where oxygen is being administered.
• DO NOT clean with aromatic hydrocarbons.
• DO NOT steam autoclave.
• DO NOT gas sterilize with (EtO) Ethylene Oxide.
• DO NOT immerse Oxygen Monitor or Sensor in liquid.

Specifications

Base Device Specifications
Dimensions (Monitor without cable and sensor attached):

• Length: 1.72” (4.36 cm)
• Width: 3.56” (9.04 cm)
• Height: 5.44” (13.82 cm)
• Cable Length: 10 ft. (3.05m) (fully extended)

Weight:

• Device Weight: 1.11 lbs (0.50 kg) (includes: monitor, sensor, batteries and cable)
• Shipping Weight: 1.64 lbs (0.75 kg)

Operating Conditions:

• Temperature: 50ºF- 113ºF (10ºC – 45ºC)
• Altitude: Sea Level to 8000 feet

Storage Conditions:

• Temperature: 5°F – 122°F (-15°C- 50°C)
• Humidity: 0 – 95% non-condensing
• Power Requirements: 4, AA Alkaline Batteries (4 x 1.5 Volts) 6 VDC
• Battery Life: approximately 2000 hours (continuous use non-alarm condition)
• Diverter Fitting: fits industry standard, 15 mm “T” adapter
• Measurement Range: 0.0 – 100%
• Resolution: 0.1 Increments
• Accuracy & Linearity: ± 1% of full scale at a constant temperature, R.H., and pressure when calibrated at full scale
• Total Accuracy: ± 3.0% Actual Oxygen Level over full operating temperature range
• Response Time: 90% of final value in less than 12 seconds at 77°F (25ºC)
• Warm-up Time: none required

Classifi cations

• Protection against electric shock: Internally powered equipment
• Protection against water: IPX1 (Drip Proof)
• Mode of Operation: Continuous
• Sterilization: Non-Sterile Device
• Flammable anesthetic mixture: Not suitable for use in presence of a flammable anesthetic mixture
• Low Battery Indication: Low battery icon is displayed on the graphics screen and an audible alarm
• Alarm System: High/low alarms, respective flashing red LEDs and graphics, 68db audible alarm @ 1 meter
• Low Alarm Range: 15% – 99% Oxygen (Requires extra action to set below 18%)
• High Alarm Range: 18% – 100% Oxygen
• High Alarm De-Activation Setting: Above 100% (“—” will appear )
• Alarm Accuracy: Displayed value +/- 0.1
• Patient Contact: Indirect contact via gas passing through the sensor sampling site.

Sensor Specifications

• Sensor Type Precision Medical 504877 galvanic oxygen sensor (fuel cell)
• Expected Sensor Life > 1,000,000 O2 % Hours

Component Description

Oxygen Monitor Identification

Oxygen Monitor LCD Display Identification

Oxygen Sensor Component Identification

be positioned up to 10 ft from the side of the Oxygen Monitor. There are Male Plugs at each end of the Coiled Cable .
Locking Ring| Male Plugs have Locking Rings and must be engaged when in use.
Oxygen Sensor| Galvanic Oxygen Sensor
Diverter Fitting| Fitting used to connect to the Oxygen Source.

Tee Adaptor

| The Tee Adaptor is used to connect the Oxygen Sensor and Diverter Fitting to an oxygen pathway circuit.

Note: The Tee Adaptor is intended for single patient use only.

Battery Installation

CAUTION
Use ONLY AA Alkaline Batteries.

1. Press down the center, top edge of the battery cover and slide down.
2. Remove old batteries, if applicable.
3. Install 4 AA Alkaline Batteries, and follow the diagram stamped in the bottom of the battery compartment.
4. Slide the battery cover back into position until the cover snaps on to the Monitor.

Battery Installation Diagram

Operating Instructions

CAUTION
Inspect the Oxygen Monitor, Sensor and Cable for visual damage before use, DO NOT USE if damaged.

WARNING
Read this User Manual before installing or operating the Oxygen Monitor.

Quick Setup Guide

1. Install 4 AA Alkaline Batteries.
2. Connect the Oxygen Sensor and Diverter Fitting.
3. Connect the Coiled Cable.
4. Calibrate the Oxygen Monitor.
5. Set the High/Low Alarms.

Sensor Installation

CAUTION

• Inspect the Oxygen Sensor and Diverter Fitting for visual damage or electrolyte leakage before use. DO NOT USE if damaged.
• Use ONLY an Oxygen Sensor specified by Precision Medical, Inc.
• The Oxygen Sensor should not be used in the presence of flammable anesthetics such as Diethyl Ether or Cyclopropane

WARNING

• DO NOT attempt to open or repair the Oxygen Sensor.
• The Sensor electrolyte is corrosive and contains lead.
• DO NOT let it come in contact with the skin. If it does, flush the affected area with water. Check the Sensor regularly for leaks. If the Sensor is leaking, replace it with a NEW
• Sensor. Leaking or used Sensors should be handled and disposed of in accordance with local regulations.
• An MSDS is available from Precision Medical, Inc.
• If the Oxygen Sensor is used in breathing circuits, the Diverter must be attached to the Sensor and must be used with the Tee Adapter.
• The Oxygen Sensor must be installed before the Oxygen Monitor can be operated.

1. Screw the Diverter to the bottom of the Oxygen Sensor, and tighten until snug.
2. If using the Tee Adapter, attach to the Diverter.
3. Insert one end of the Coiled Cable into the top of the Sensor, and secure by tightening the Locking Ring, until snug.
4. Insert the other end of the Coiled Cable into the Sensor Cable Connection located on the right side of the Oxygen Monitor. Secure it in place by tightening the Locking Ring, until snug.
5. Wait approximately 20 minutes for the NEW Sensor to stabilize the environment.
6. Calibrate the Oxygen Monitor with the NEW Sensor.

CAUTION

1. Calibrate the Oxygen Monitor before each use, and when replacing the Oxygen Sensor or the batteries.
2. The Precision Medical Oxygen Monitor can only be calibrated accurately using 100% Oxygen or 20.9% Oxygen (Room Air). Using any other concentration will result in inaccurate readings.
3. Air calibration is not recommended unless the Sensor can be exposed to a known source of clean air. Hospital room air is often enriched with excess oxygen.
4. Calibrate the Oxygen Monitor at a pressure and flow similar to your clinical application.
5. Before calibrating the Oxygen Monitor, the oxygen concentration readout should be stable and not drift more than 0.2%.
6. DO NOT calibrate the Oxygen Monitor in humidified gas, as water vapor makes the oxygen concentration appear lower than the actual value.

Calibration

1. Place the Sensor with the Diverter and Plastic Tee attached into the gas stream of 100% USP Oxygen or room air. The highest accuracy is achieved when using 100% USP Oxygen at constant pressure and flow.
2. Wait at least 20 seconds or more for the oxygen to purge the line.
3. Turn the Oxygen Monitor “ON” by pressing the POWER key.
4. Let the oxygen concentration display stabilize, the readout should not drift more than 0.2%.
5. Press the key to UNLOCK the keys.
6. Press the CAL key. The display will show “@ 21%” or “@ 100%” oxygen. When “DONE” appears, the calibration is complete. The Oxygen Concentration will be displayed in a gas percent value. Press LOCK/UNLOCK to save the calibration data. If no keys are pressed within 3 seconds, the setting will be saved, and the keypad will be locked.
7. Remove the Oxygen Sensor from the oxygen supply and confirm that the display reads between 19-22% Oxygen in room air.

Effects of Temperature
To minimize temperature effects:

1. In a breathing circuit, place the Oxygen Sensor upstream of the heater.
2. Allow time for the Oxygen Sensor to stabilize to its new room temperature.
3. Perform the calibration procedure at a temperature close to or similar to your clinical application

Effects of Elevation/Barometric Pressure Changes
This device does not automatically compensate for changes in barometric pressure. Calibration of the Monitor shall be performed when the elevation at which the device is being used changes by more than 500 feet.

Effects of Humidity

• High Moisture levels will dilute the oxygen concentration, decreasing the concentration of oxygen being monitored by the Oxygen Sensor.
• High humidity can cause condensation to collect on the Oxygen Sensor, obstructing the passages and reducing the effectiveness of Oxygen Sensor.

CAUTION

To reduce the effects of humidity on the Sensor:
DO NOT USE the Oxygen Sensor in environments with greater than 95% humidity. Place the Oxygen Sensor upstream from the humidifier in a breathing circuit.

Effect of Pressure

CAUTION
The Oxygen Monitor is not equipped with automatic barometric pressure compensation.

• When the Oxygen Sensor is placed in a breathing circuit, the alternating “breathing” pressure cycles will be sensed as an increase in oxygen concentration. The concentration is not actually changing, but it appears to be due to the change in pressure.
• The following recommendation is provided to reduce the chances of pressure causing false readings.
• Calibrate the Precision Medical Oxygen Monitor using 100% Oxygen or room air at the same pressure and flow as the gas to be monitored.

Effects of Anesthetic Gases

Anesthetic Agent| Test Concentration| Oxygen Concentration Error
---|---|---
Helium| 50%, Balance Oxygen| 0%
Nitrous Oxide| 80%, Balance Oxygen| 0%
Carbon Dioxide| 10%, Balance Oxygen| 0%
Halothane| 4%| <1.5% Oxygen
Enflurane| 5%| <1.5% Oxygen
Isoflurane| 5%| <1.5% Oxygen
Sevoflurane| 5%| <1.5% Oxygen
Desflurane| 15%| <1.5% Oxygen*

Test mixture = 30% O2, balance 70% N2O except where noted.

Errors may vary based on concentrations and exposure times. These results meet or exceed the requirements of ISO 7767 and DIN EN 12598.

CAUTION
The Oxygen Sensor should not be used in the presence of flammable anesthetics such as Diethyl Ether or Cyclopropane.

Alarms
The Precision Medical Oxygen Monitor will store the HIGH/LOW alarm settings in memory after the Oxygen Monitor is turned “OFF”. The Oxygen Monitor is designed to prevent a crossing of the HIGH/LOW alarm settings. The LOW alarm cannot be set above the HIGH alarm and the High alarm cannot be set below than the LOW alarm.

Operator’s Position – Visual alarms are best viewed at a distance of 3 feet (1m) or less from the Oxygen Monitor along with the following conditions;

• the Operator has a visual acuity of 0 on the logMAR scale or 6-6 (20/20) vision(corrected if necessary),
• the viewpoint is at the Operator’s Position or at any point within an angle of 30° to the axis horizontal to the center of the plane of the monitoring display, and
• the ambient luminance in the range of 100 lx to 1 500 lx.

To Set Alarms

WARNING
Do Not set alarm limits to extreme values that can render the alarm system useless.

1. With the Power key ON.

2. Press the LOCK/UNLOCK key.

3. To set the HIGH Alarm: Press the HIGH ALARM SET key once. Press the UP and DOWN arrow keys until the desired value is displayed next to the Up arrow in the upper right corner of the display. Continuously pressing the arrow keys will move the value in increments of 5. Press the HIGH ALARM SET key to save the setting. A flashing Number indicates the Number can be changed. If no keys are pressed for 10 seconds, the setting will be saved and the Oxygen Monitor will revert to locked mode.

4. To set the LOW Alarm: Press the LOW ALARM SET key once. Press the  UP and DOWN arrow keys until the desired value is displayed next to the Down arrow in the lower right corner of the display.
   Continuously pressing the arrow keys will move the value in increments of 5. Press the LOW ALARM SET key to save the setting. A flashing Number indicates the Number can be changed. If no keys are pressed for 10 seconds, the setting will be saved and the Oxygen Monitor will revert to locked mode.
   To set the LOW Alarm below 18%: Press the LOW ALARM SET key once. Press the DOWN arrow key until 18% is displayed. Press and hold the LOCK/UNLOCK key down and press the DOWN arrow key to set the lower limit and then release the LOCK/UNLOCK key.

5. Lock the display by pressing the LOCK/UNLOCK key.

6. To disable the HIGH Alarm, raise the HIGH Alarm setting above 100%. “—” will be displayed next to the Up arrow on the display. The LOW alarm will still function while the HIGH alarm is disabled.

Alarm Situation
During a HIGH or LOW alarm.

1. Triple pulse alarm sounds.
2. The LED will flash.
3. The alarm Low/High set point will flash.
4. UP or DOWN Arrow will turn dark.

Pressing the Alarm Silent key will deactivate the audible alarm for 120 seconds. If the alarm exists after 120 seconds, the alarm will sound again.

Cleaning

CAUTION

• DO NOT steam autoclave.
• DO NOT immerse the Oxygen Monitor in any liquid.
• DO NOT use any strong solvent or abrasive cleaners.
• DO NOT allow any liquid to enter the Oxygen Monitor or the Oxygen Sensor; this will damage the Oxygen Monitor or Oxygen Sensor and will void the Warranty.

1. Disconnect all connections before cleaning.
2. Clean the exterior surfaces of the Oxygen Monitor and Coiled Cable with a cloth dampened with mild detergent and water.
3. Wipe dry with a clean cloth.

Maintenance

Sensor Replacement
Reference “SENSOR INSTALLATION”

CAUTION
Sensor Replacement must be performed by Qualified Medical Personnel.

Battery Replacement

• Replace batteries when (Low Battery) is displayed.
• Reference “BATTERY INSTALLATION”.

Returns
Returned products require a Returned Goods Authorization (RGA) number, contact Precision Medical, Inc. All returns must be packaged in sealed containers to prevent damage. Precision Medical, Inc. will not be responsible for goods damaged in transit. Refer to Precision Medical, Inc. Return Policy available on the Internet, www.precisionmedical.com.

Disposal Instructions

• The Oxygen Monitor may contain electrical components that are hazardous to the environment. DO NOT dispose device into standard trash.
• The Oxygen Monitor contains internal batteries. Batteries contain materials that can contaminate the environment when improperly disposed of.
• The Oxygen Sensor contains lead. DO NOT dispose sensor into standard trash. Dispose of in accordance with the local regulations.
• Contact your local waste management for the disposal of Electronic Equipment.

Troubleshooting

If the oxygen monitor fails to function, consult the Troubleshooting Guide. If the problem cannot be solved by using Troubleshooting Guide, consult your Provider.

connections are not secure

2.   Oxygen Sensor not functioning

3.   Using Oxygen Sensor other than Precision Medical Oxygen Sensor

| 1.   Make sure cable connections are secure and locking rings are tight

2.   Replace with New Precision Medical Oxygen Sensor

3.   Attach New Precision Medical Oxygen Sensor

New Oxygen Sensor responds slowly or seems to drift| 1. Oxygen Sensor has NOT temperature stabilized| 1. Wait approximately 20 minutes for Oxygen Sensor to stabilize with the environment, and then recalibrate the Oxygen Monitor
Oxygen Sensor does not react to changes in oxygen concentration| 1. Condensation on the Oxygen Sensor

2. Nonfunctioning Oxygen Sensor

| 1.   Remove Condensation

2.   Replace with New Precision Medical Oxygen Sensor

Triple Pulse Alarm and flashing LED| 1.   Oxygen readings are outside the High/Low Alarm limits

2.   Loss of Air or Oxygen Supply

| 1.   Adjust the High/Low Alarm setting to be above/below the oxygen value being displayed

2.   Reconnect the Air or Oxygen Supply

Keys inoperable (Power ON)| 1. The keypad is locked| 1. Unlock the keypad
No Display / LCD screen will not power ON| 1.   Dead Batteries

2.   Battery installed incorrectly

| 1.   Check and replace with 4 New AA alkaline batteries

2.   Check that batteries are installed in the proper position (+/-)

“SERVICE NEED” appears on the display| 1. Electronic malfunction| 1. Oxygen Monitor must be serviced
“CAL FAIL” appears on the display| 1.   Improper or wrong Oxygen Sensor

2.   Improper Air / Oxygen source

3. Nonfunctioning Oxygen Sensor

| 1.   Recalibrate the Oxygen Monitor

2.   Check the Air / Oxygen source

3.   Replace with New Precision Medical Oxygen Sensor

ALARM CONDITIONS

prescribed dose

Set high alarm to a prescribed limit

Low alarm LED flashing and audible beep| Measured O2 concentration is lower than the low alarm set point| Adjust O2 concentration source to the prescribed dose

Set low alarm to a prescribed limit

Low Battery symbol on and O2 displays “- – -“ instead of a value| The voltage output of the installed batteries is low and will require replacement soon| Replace all batteries with new batteries
Oxygen Sensor symbol on| Oxygen Sensor failure| Replace O2 sensor

Recalibrate O2 Monitor

Replacement Parts

Accessories

Orders for replacement parts should include the part number, if available and the model and serial number of the instrument for which the parts are intended.

Limited Warranty and Limitation of Liability

Precision Medical, Inc. warrants that the Oxygen Monitor, (the Product), will be free of defects in workmanship and/or material for the following period:

Two (2) years from shipment.

• Precision Medical, Inc. is NOT responsible for normal wear and tear, or any neglect or abuse of the product.
• The customer is responsible for the shipping costs of repairs back to Precision Medical, Inc.
• Precision Medical, Inc. will have in its sole and absolute discretion, the final determination if your product is covered under this limited warranty.

Should any failure to conform to this warranty appear within the applicable period, Precision Medical, Inc. shall, upon written notification thereof (received by Precision Medical, Inc. within 30 days of the customer’s discovery of the alleged defect), along with the return of the Product at the customer’s expense and substantiation that the goods have been stored, installed, maintained and operated in accordance with Precision Medical, Inc.’s instructions and standard industry practice, and that no modifications, substitutions, or alterations have been made to the goods, correct such defect by repair or replacement (at Precision Medical, Inc.’s option) at its own expense.

Precision Medical, Inc. warrants the 504877 Oxygen Sensor included with the PM5900 Oxygen Monitor to be free from defects in material and workmanship for a period of sixteen (16) months, from the date of shipment. Should any failure to conform to this warranty appear within the applicable period, Precision Medical, Inc. shall, upon written notification thereof (received by Precision Medical, Inc. within 30 days of the customer’s discovery of the alleged defect), along with the return of the sensor at the customer’s expense and substantiation that the sensor has been stored, installed, maintained and operated in accordance with Precision Medical, Inc.’s instructions and standard industry practice, and that no modifications, substitutions, or alterations have been made to the sensor, correct such defect by repair or replacement (at Precision Medical, Inc.’s option) at its own expense.

Should a sensor require repair or replacement due to said defects, the sensor is warranted only for the remainder of the original sensor warranty period. A sensor shall not be considered defective for failure to function beyond its normal estimated consumption capacity/rates, and this warranty does not cover normal wear due to consumption beyond the sensor’s estimated O2% hours.

ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES.
The representatives of Precision Medical, Inc. or any retailers are not authorized to make oral warranties about the merchandise described in this warranty, 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 the warranty for the products covered by the applicable contract.

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.

Precision Medical, Inc. 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 liabilities of Precision Medical, Inc. whether based on contract, negligence, strict tort or otherwise. Precision Medical, Inc. reserves the right to discontinue the manufacture of any product or change product materials, designs, or specifications without notice.

Precision Medical, Inc. reserves the right to correct clerical or typographical errors without penalty.

300 Held Drive Northampton PA 18067, USA.
www.precisionmedical.com.
T: (+001) 610-262-6090
F: (+001) 610-262-6080 ISO 13485 Certified.

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