510 (k) K952736 O2 Sensor

510 (k) K053407 O2 Analyzers

Medical Device Directive: 93/42 EEC, Annex II

EN ISO 13485:2012/AC:2012

EN ISO 80601-2-55:2011, Part 2-55

0123 Particular requirements to the basic safety and
essential performance of respiratory gas monitors

EN ISO 14971:2012
Application fo risk management to medical devices

ISO 9001:2008

Authorized EC Representative:
Distribuciones Y Representaciones Biomedicas Direx, S.L.
Avda. San Pablo, 28. Nave 24,
2882 Coslada Madrid, Espana

Health Canada: Medical Devise

Regulations, F-27/ SOR-98-282
ISO 13485:2003
CMDR, CMDCAS OGX-1900-A

Instructions for Use

Copyright © All Rights Reserved OGX-1900-HC
Effective 7/17
Revised: July 2017

BC Group International, Inc.

3081 Elm Point Drive, St. Charles, MO 63301 USA.
Tel: 314-638-3800, Fax: 314-638-3200
e-mail: [email protected], web: www.bcgroupintl.com

This manual may not be reproduced in whole or in part without the prior
written consent of BC Group International, Inc. OGX-1900-M
Table of Contents 1 Introduction
1 Introduction 1 Congratulations on your purchase, these Instructions for Use describe the pre-
cautions, set-up, operation, maintenance and specifications of the OGX-1900
1.1 Indications for Use 1 Series Oxygen Analyzers & Monitor.
1.2 Intended Use 2
1.3 Device Description 3 This symbol means CAUTION – Failure to read and comply with the
2 General Safety 4 Instructions for Use could damage the device and possibly jeopardize
the well being of the patient and/or health care professional.
3 Start-up 6
3.1 Contents of Shipping Container 6 Note: BC Group International, Inc. cannot warrant any damage resulting from
the misuse, unauthorized repair or improper maintenance of the device.
3.2 Install Batteries 7
3.3 Install Oxygen Sensor 8
1.1 Indications for Use
3.4 Controls 9
3.5 Start-up Test 10 The OGX-1900 Series Oxygen Analyzers & Monitor are intended to measure and
display the concentration of oxygen in breathing gas mixtures. The intended
3.6 Alarms (OGX-1900 M Oxygen Monitor) 12
3.7 Mounting 13 use is only to verify, spot check or continuously monitor, oxygen concentrations
in circumstances where the oxygen concentration is controlled and set by other
4 Calibration 14 medical device such as oxygen/air blenders, flow meters or other control de-
vice.
5 Operation 17
5.1 Principle of Operation 17 Users must read the following statements as they are essential to
5.2 Application Considerations 18 reducing the risk of use error due to ergonomic features of the device
5.3 Sampling 20 or the environment in which the device is intended to be used.

6 Maintenance 22 The devices as identified in Section 12 Declaration of Conformity have been

designed and manufactured in such a way that when used under the conditions
6.1 Serviceability 22 and for the purposes intended, they will not compromise the clinical condition
6.2 Battery Replacement 22 or the safety of patients, or safety of the users or other persons.
6.3 Oxygen Sensor Replacement 23
6.4 Sensor Life Expected & Warranty 25 Federal law restricts this device to sale by or on the order of a physician.
7 Spare Parts & Accessories 25
Conformity with essential requirements has been demonstrated by verifying the
8 Troubleshooting 26 performance of the device under normal conditions, bench testing, pre-clinical
and simulated clinical evaluations and determining that undesirable malfunc-
9 Warranty 28 tions constitute minimal risk to patients and users.
10 Safety Data Sheet (SDS) & Disposal 29
Particular requirements for sterilization do not apply to these devices. Do not
11 Specifications 30 sterilize, autoclave, liquid sterilize, immerse in any liquid or expose the device
or accessories to steam, ethylene oxide or radiation sterilization.
12 Declaration of Conformity 32
13 Quality Control & Calibration Certification 34

i 1
The device is intended to be re-usable. Should the device or accessories come 1.3 Device Description
in contact with patient bodily fluids, either dispose of the device or clean with The OGX-1900 Series Oxygen Analyzers and Monitor can be positioned on a
a soft cloth dampened with 70% isopropyl alcohol solution in water and allow table top or pole (tripod wire stand and V-mount dovetail attachments are
the components to air-dry before re-use. mounted on the back of the device) and are readily portable from one location
to another. They provide continuous, fast, reliable and accurate oxygen meas-
The device and accessories are not intended to transport or store any medi- urements of up to respiratory care systems.
cines, body liquids or other substances that can be administered or removed
from the body, and, do not contain any latex, human blood derivatives, phtha- The devices utilize an electrochemical galvanic fuel cell type oxygen sensor of
lates, carcinogens or other reproductive toxics. the type that is extensively used to measure oxygen concentrations from 0%
to 100% in gas streams. Oxygen, the fuel for this electrochemical transducer,
Calibrate the device with 100% oxygen before using each day or after 8 hours diffusing into the sensor through a gas permeable membrane reacts chemi-
of continuous use. In the event the device fails to calibrate or if the reading cally at the sensing electrode to produce an electrical current output propor-
becomes unstable, do not attempt to use the device. Contact the manufac- tional to the oxygen concentration in the gas phase. The sensor has an abso-
turer for assistance. lute zero meaning that when no oxygen is present to be chemically reacted
the LCD displays 00.0 oxygen.
Do not operate the analyzer near equipment capable of emitting high levels of
electromagnetic radiation as the reading may become unstable. The sensor’s signal output is linear over the entire range, remains virtually
constant over the specified useful life and drops off sharply at the end. The
In order to obtain optimum performance, the operation of the device must be sensor itself requires no maintenance and is simply replaced at the end of its
performed in accordance with these Instructions for Use. Maintenance should useful life like a battery. Inasmuch as the sensor is a transducer in its own
be performed only by trained personnel authorized by the manufacturer. right, its expected life is not affected by whether the analyzer is ON or OFF.

1.2 Intended Use A battery powered state-of-the-art micro-processor converts the sensor’s sig-
The OGX-1900 Series Oxygen Analyzers & Monitor are intended for short term nal output representing the partial pressure of oxygen in the gas stream being
use in combination with therapeutic devices such as lung ventilators and incu- analyzed. The resulting oxygen reading is displayed by a large easy to read
bators; monitoring vital physiological processes and parameters such as respi- backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The
ration, anesthesia, intensive or emergency care; monitoring the administration microprocessor is controlled from a keypad and provides features like system
of gases using ventilators, anesthesia machines, hyperbaric chambers and diagnostics, warning indicators, controls and an alarm capability for continu-
medical gas mixers. ous monitoring that enhance both safety and effectiveness.

The OGX-1900 Series Oxygen Analyzers & Monitor measure and display an Prior to shipment, every device is thoroughly tested at the factory and docu-
independent secondary confirmation of the oxygen concentration in breathing mented by the Quality Control & Calibration Certification in section 13 that is
gas mixtures administered by other devices. included in the Instructions for Use supplied with every device.

The manufacturer’s contact information and serial number of this device can
be found above the battery compartment cover on the rear of the device and
in Section 13 Quality Control Certification.

In conclusion, BC Group International, Inc. appreciates the opportunity to

supply this device and anticipates many years of useful service.

2 3
2 General Safety NEVER operate the device in any manner described below doing so
may compromise the clinical condition or the safety of patients, users
or other persons.
ALWAYS follow the statements below as they are essential to reduc-
ing the risk of use error due to ergonomic features of the device or If the reading is unstable or a malfunction is suspected.
the environment in which the device is intended to be used. After the battery symbol appears in the LCD display.
Only trained personnel who have read, understand and agree to follow the Near equipment capable of emitting high levels of electromagnetic radiation
Instructions for Use should operate the device. (EMI) or radio frequency interference (RFI). For example, near X-ray and
Retain the Instructions for Use for future reference. MRI machines.

Refer service needs to trained authorized personnel. Failure to do so may Expose the device; particularly the LCD display or sensor to sources of ex-
cause the device to fail and void the warranty. treme heat, cold or excessive sunlight beyond the device’s storage tem-
perature range, refer to section 11, for extended periods of time.
Inspect the device and accessories before operating and ensure: (a) there is
no evidence of physical damage; (b) the sensor’s sensing surface is dry; In a gas stream with a vacuum greater than 14” water column.
and, (c) the sensor is installed upstream from any humidifying device for Immerse the device, oxygen sensor or coiled cable in any liquid.
accurate calibration and oxygen measurements.
Outside of the parameters specified in Section 8 particularly at flow rates
Calibrate: (a) with a known source of dry 100% oxygen before using each greater than 10 liters per minute - the backpressure generated produces
day or after 8 hours of continuous use; (b) when the temperature erroneously high oxygen readings.
changes more than +10°C from calibration temperature; (c) when the
pressure of the operating environment changes; (d) if the oxygen sensor
Calibrate: (a) with 20.9% oxygen or room air with the intent of taking oxygen
has been disconnected and reconnected; (e) after the battery or oxygen measurements at oxygen levels above 30% oxygen; (b) in a humidified
sensor has been replace. gas stream or atmosphere; (c) without allowing a newly installed sensor to
stabilize for 15-20 minutes in ambient air.
Sampling flowing gas: (a) install the flow diverter and the tee-adapter in a
vertical position as shown in Section 5.3 and (b) assure there is a tight fit
Attempt to sterilize, autoclave, liquid sterilize, immerse in any liquid or ex-
between the flow diverter and tee adapter. pose the device or accessories to steam, ethylene oxide or radiation sterili-
zation.
Sampling static, ambient or controlled atmospheres such as incubators,
oxygen hoods, tents, etc.: remove the flow diverter.
In the presence of flammable anesthetic gases.
Open the main compartment of the device, except to change the integral
Clean the device and accessories in accordance with Section 6.1.2. oxygen sensor of the OGX-1900 HC Oxygen Analyzer.
Battery replacement Section 6.2: (a) replace the batteries within twenty- Open the oxygen sensor or probe the sensing surface, refer to Section 10 in
four (24) hours of the battery symbol appearing on LCD display and (b) the event the sensor should leak and someone comes in contact with the
calibrate the analyzer after replacing the batteries. electrolyte from inside the sensor.
Oxygen sensor installation or replacement Section 6.3: allow the new sensor Operate with a cable that appears worn, torn or cracked, or, allow an excess
to stabilize for 15-20 minutes in ambient air before attempting to cali- length of cable near the patient’s head or neck; secure it to the bed rail or
brate. other suitable object to avoid the possibility of strangulation.
Store the device by turning the power OFF and removing the batteries if the Allow the device or oxygen sensor to be serviced, repaired or altered by any-
device will not be operated for over thirty (30) days. one except trained personnel – failure to do so may endanger the patient
Attempt to repeat the procedure that caused a perceived malfunction and or damage the device rendering the warranty null and void.
refer to troubleshooting hints in Section 8 before concluding the device is
faulty. If in doubt, contact the manufacturer for assistance.

4 5
3 Start-Up 3.2 Install Batteries
All devices are powered by two 1.5V AA alkaline batteries which must be in-
stalled before the device can be operated.
3.1 Contents of Shipping Container:
The battery compartment is located at the rear of all devices. Initially
3.1.1 OGX-1900-A Oxygen Analyzer, and OGX-1900-M Oxygen Monitor: this procedure can be somewhat difficult. Care should be taken not to
ENCL-1061 V-mount retainer (attached) damage the case when removing the battery compartment cover.
ENCL-1066 Tripod wire stand (attached)
AII-11-60 Oxygen Sensor
BATT-1008 Battery, AA 1.5V Alkaline (Qty 2)
CABL-1006 Cable, Coiled Phone Jack
FITN-1009 Blue Tee Adapter
FITN-1112-1 Flow Diverter
Instructions for Use

AND
OR
3.2.1 Procedure:
1. Remove the device and the (2) AA 1.5V Alkaline batteries from the foam
shipping container.
2. Turn the device over so the shortest raised line on the battery compart-
3.1.1 OGX-1900-HC Oxygen Analyzer, Home Care: ment cover is pointing away from you.
ENCL-1061 V-mount retainer (attached) 3. Lift the tripod wire stand up and away from the case.
ENCL-1066 Tripod wire stand (attached) 4. Grasp the case with both hands, use your thumbs press down firmly on
AII-11-60-HC Oxygen Sensor (installed inside analyzer) the raised lines and push the battery compartment cover away from you.
BATT-1008 Battery, AA 1.5V Alkaline (Qty 2) 5. Locate the positive (+) and negative (-) terminals on the battery.
TUBE-1007 Tubing, 1/4” Tubing 7 ft. with Adapter 6. Assure the battery contacts are clean.
Instructions for Use 7. Align one battery’s positive (+) terminal with the corresponding (+) bat-
tery symbol molded into the case.
8. Insert the battery into the compartment.
9. Repeat with the remaining battery.
10. Replace the battery compartment cover, make sure it snaps into position
AND
and is secured flush against the case. Replace the wire stand as required.

Replace the batteries within twenty-four (24) hours of the battery

symbol appearing on LCD display because batteries decline at different
rates. Calibrate the device after replacing the batteries.

Inspect the box and contents for shipping damage. If the device or
components appear damaged, do not attempt to operate the device -
contact the manufacturer immediately, refer to section 9.

6 7
3.3 Install Oxygen Sensor 3.4 Controls
The device cannot function until the oxygen sensor is installed. Once installed,
allow the sensor to stabilize for 15-20 minutes in ambient air before attempt- 3.4.1 OGX-1900-A and OGX-1900-HC Oxygen Analyzers
ing to calibrate the device. These analyzers employ a micro-processor that is controlled by five (5)
pushbuttons located on the keypad attached to front cover.
NEVER - Attempt to open, repair or service the oxygen sensor. 1. ON/OFF provides power to the electronics
Refer to section 2 for hints and warnings concerning the handling and 2. ESCAPE aborts a previous selected option
environmental considerations of the oxygen sensor and the device. 3. ENTER selects a menu option
4. 100% initiates the routine for CALIBRATION with 100% oxygen. The sen-
3.3.1 OGX-1900-A Oxygen Analyzer, OGX-1900-M Oxygen Monitor: sor must be exposed to 100% oxygen.
1. Remove the contents from the shipping container as shown in section 3.1 5. 21% initiates the routine for CALIBRATION with air or 21% oxygen. The
and check for damage. sensor must be exposed to air or 21% oxygen.
2. The coiled cable uses a common RJ11 phone jack at both ends, making a
bad connection impossible. 3.4.2 OGX-1900-M Oxygen Monitor
3. Install the sensor away from any humidifying device to prevent moisture The monitor employs a menu driven micro-processor that is controlled by five
from condensing on the sensing surface and assure accurate calibration (5) pushbuttons located on the keypad attached to front cover.
and oxygen readings. 1. ON/OFF provides power to the electronics
4. Connect one end of the cable to the device in the same manner you 2. MENU accesses the MAIN MENU
would connect a telephone. Simply find and register the male plug at the 3. ENTER selects a menu option, and, enables the user to silence the audible
end of the coiled cable and insert it into the mating female jack on the alarm quickly without having to navigate through the menu(s)
side of the device. 4. DOWN ARROW scrolls down the menu options
5. Connect the other end of the cable to the sensor in the same manner. 5. UP ARROW scrolls up the menu options
6. For diffusion sampling of static, ambient or controlled atmospheres –
incubators, infant hoods, tents, etc., the flow diverter and tee are not Note: The monitor is equipped with visual and audible HIGH and LOW
required as shown above. (minimum set point of 15%) alarms which are controlled through the MAIN
7. For sampling breathing circuits with flowing gas, use the flow diverter MENU and are activated when the oxygen value is 0.1% below the LO alarm
and tee adapter accessories supplied with the device, and, position the set point or 0.1% above the HI alarm set point, refer to section 3.6 below.
sensor vertically for optimum results, as shown right. The flow diverter
avoids stagnation and facilitates the movement of gas to and from the 3.4.3 Instructions and Warnings displayed by LCD
sensing area of the sensor thereby producing a more accurate measure-  START-UP TEST – diagnostic tests of the electronics, alarm circuit
ment of the gas stream to be measured. (monitors only), battery voltage and the sensor’s signal output.
8. Install the tee-adapter in the breathing circuit.  SERVICE DEVICE – non-sensor failures during the start-up test.
9. Screw the flow diverter to the sensor.  CHECK SAMPLE GAS, CHECK CABLE, CHECK SENSOR – sensor fails the
10. Ensure the o-ring is lightly lubricated for ease of entry and a tight seal
start-up test or becomes disconnected during operation, or if an alarms is
between the flow diverter and tee adapter.
activated (monitor).
11. Insert the assembled flow diverter/sensor into the tee allowing 100%
oxygen (dry, non-humidified) to flow past the sensor at a rate less than
 SAMPLING – oxygen concentration from 0-100% in the sample gas during
10 liters per minute. the normal operation.
 BAT LOW – battery voltage is not adequate, replace batteries.
3.3.2 OGX-1900-HC Oxygen Analyzer:  ALARM SET POINTS, CONDITION (set point reverses color and red LED
When the Home Care version with its integral oxygen sensor is ordered, the indicator turns on) for monitor only.
device is shipped with the sensor installed.

8 9
3.5 Start-Up Test 3.5.2 Sensor Failure
Press the ON/OFF key on the front panel to apply power to the device and Sensor failure can result from multiple causes; the user’s failure to connect a
initiate a complete diagnostic test of all system functions: the electronics, sensor or sensor cable, a defective sensor cable or a sensor with an output
feeds voltage and tests the alarm circuit (monitor only below right) internally, outside specification.
confirms the battery voltage is adequate to power the circuit, and, the sen-
sor’s signal output is within specifications. SENSOR - FAILED LOW is one of the possible unsuccessful START-UP TESTs as
illustrated previously and displays additional warnings as follows.
START-UP TEST START-UP TEST
3.5.2.1 OGX-1900-A and OGX-1900-HC Oxygen Analyzers
ELECTRONICS - PASS ELECTRONICS - PASS The LCD alternately displays the following until the problem is corrected.
ALARMS - N/A ALARMS - PASS

0.0 %
BATTERY - PASS BATTERY - PASS
SENSOR - PASS SENSOR - PASS CHECK SAMPLE GAS
CHECK CABLE
CHECK SENSOR

Following successful Start-Up Test the devices default to the SAMPLING mode. ALARM ALARM

20.9 % 20.9 %
Corrective action:
1. Expose the sensor to air or a gas containing approximately 20.9% oxygen
2. Connect or replace the cable connecting the sensor to the analyzer
3. Connect or replace the oxygen sensor
SAMPLING SAMPLING
LO 15% HI 50% 3.5.2.2 OGX-1900-M Oxygen Monitor
Performs the same routine and requires the same corrective action as the ana-
With the exception of the ALARMS for the OGX-1900-M (above right) the tests lyzers above with additional indicators related to the monitor’s alarm feature.
and resulting displays are the same.

Note: Any START-UP TEST failure requires the user to take correc-
tive action before continuing or attempting to use any device. 0.0 % CHECK SAMPLE GAS
CHECK CABLE
CHECK SENSOR

3.5.1 Electronics, Alarms (OGX-1900-M Monitor) or Battery Failure ALARM ALARM

If any of these START-UP TESTs are unsuccessful, the following display in- LO 15% HI 50% LO 15% HI 50%
structs the user to SERVICE DEVICE. The following display is the same for all
models. In addition to the alternating LCD display, the LO ALARM becomes active and:
 LO ALARM value and background alternately reverse colors on the LCD
START-UP TEST
 RED LED below the LO ALARM value lights up and begins flashing
ELECTRONICS - FAILED  Audible alarm begins beeping
ALARMS - FAILED
BATTERY - FAILED The audible alarm can be disabled for two (2) minutes (unlimited times) by:
SENSOR - FAILED LOW 1. Press the MENU key on the front panel
SERVICE DEVICE 2. Press the UP/DOWN arrow to select ALARMS AUDIBLE
3. Press the ENTER key to toggle to ALARMS SILENT mode

10 11
3.6 Alarms OGX-1900-M Oxygen Monitor 3.7 Mounting
The monitor is equipped with user selectable HI and LO alarm set points Every analyzer and monitor is equipped with a male dove tail bracket and
which are displayed at the bottom of the LCD. The default alarm set points triangular shaped thick metal wire stand secured to the rear of the enclosure.
are 15% LO and 50% HI. The LO alarm set point can be set between 15%
and 99% and the HI alarm set point can be set between 16% and 100%. Tripod Wire Stand
Secured between bumper feet on either side of the battery compartment is a
Alarm set points may be adjusted in 1% increments by pressing and holding triangular shaped thick metal wire stand that is hinged under the dove tail
the UP/ DOWN ARROW keys, see below. The ARROW keys are disabled when bracket secured at the opposite end of enclosure.
the alarm set points are within 1% of each other to prevent the HI alarm from
being set below the LO alarm. The HI alarm may be disabled by attempting to Unsnap the triangular thick metal wire stand from between the bumper feet
select a HI alarm set point above 100% to facilitate flushing patients after and pull it away from the enclosure to form a tripod which allows the device to
anesthesia. In this mode the LCD continually displays HI OFF. sit upright on any flat surface

The OGX-1900-M Oxygen Monitor is equipped with four (4) indicators that
activate when oxygen concentrations are 0.1% below the LO alarm set point
or 0.1% above the HI alarm set point.
1. LCD alternates between the ALARM mode with an oxygen reading 0.0%
and recommendation as illustrated in sections 3.5.2.1 and 3.5.2.2
2. Alarm value and background alternately reverse color on LCD
3. Red LED below the alarm value lights up and begins flashing
4. Audible alarm begins beeping

3.6.1 Setting Alarm Set Points

1. From the SAMPLING mode press MENU
to display the MAIN MENU
2. Press the UP/DOWN arrow keys to
20.9 %
highlight SET ALARMS
SAMPLING
3. Press ENTER to select SET ALARMS LO 15% HI 50% Dove Tail Bracket
4. LO alarm value is highlighted by default The male dove tail bracket is secured to the rear of the enclosure with two
5. Press ENTER to skip the LO alarm (and screws. The 1” female dove tail pole bracket (HRWR-1075) is an optional ac-
proceed to the HI alarm) or press the MAIN MENU cessory that is commonly found in medical applications. The v-shaped male
UP/DOWN arrow keys to change the component simply slides into and out of the pole mounted female section.
CALIBRATE
alarm set point SET ALARMS
6. Press ENTER to save LO alarm set point ALARMS AUDIBLE
and move to select the HI alarm
7. Press ENTER to skip the HI alarm (and LO 15% HI 50%
return to SAMPLING mode) or press the
UP/DOWN arrow keys to change the
SET LOW/HIGH ALARM
alarm set point
8. Press ENTER to save HI alarm set point USE UP/DOWN ARROWS
and return to SAMPLING mode TO ADJUST VALUE
9. If no key is pressed within 5 seconds,
the LCD returns to the SAMPLING mode TO SKIP - PRESS ENTER
LO 15% HI 50%

12 13
4 Calibration Procedure
OGX-1900 Series Analyzers and Monitor employ the identical calibration rou-
tine and displays but they differ slightly in the way they arrive at the display
Electrochemical oxygen sensors generate slightly different signal outputs under
that initiates calibration routine. Refer to Set-Up illustration and references
identical conditions due to variations in the thickness of the sensing membrane
above for gas connections.
and manufacturing process.
1. OGX-1900-A and OGX-1900-HC Oxygen Analyzers - Press the 21% key
Simulate the application for optimum accuracy: Review Sections 2
under the word CALIBRATION on the front panel.
General Safety and 5.2 Application Considerations before proceeding.
1a. OGX-1900-M Oxygen Monitor - Requires navigating its menu to reach the
The devices are designed to meet the requirements for both ambient
display that initiates the calibration routine.
and elevated oxygen measurements but should NEVER be calibrated
a. From the SAMPLING menu, press
with air or 21% oxygen with the intent of taking oxygen measure- MAIN MENU
MENU to display the MAIN MENU
ments at oxygen levels above 30% oxygen.
b. Press the UP/DOWN arrow keys to CALIBRATE
highlight CALIBRATE SET ALARMS
Accordingly, the devices may be calibrated with either air (20.9%) or
c. Press ENTER to select CALIBRATE (the ALARMS AUDIBLE
100% oxygen which requires the user to make a conscious decision to
four (4) alarm indicators are disabled
bypass or skip the recommended 100% oxygen calibration. LO 15% HI 50%
during the calibration routine)
Set-Up:
Both of the above produce the following display which initiates the
calibration routine.

20.9 %
INTRODUCE AIR/21% OXYGEN
OBSERVE TREND
PRESS ENTER TO CAL

3. The above prompt remains on the display until:

OGX-1900-A and OGX-1900-M refer to section 5.4.1 Flowing Gas
a. The operator presses ENTER to proceed or
Streams or 5.4.2 Static Atmospheres.
b. The ESCAPE key on the OGX-1900-A and OGX-1900-HC or the MENU key
on the OGX-1900-M to abort and return to the SAMPLING mode.
4. Expose the sensor to a known source of fresh ambient air or certified 21%
(dry, non-humidified) oxygen nitrogen mix but not the oxygen enriched
room air commonly found in hospitals.
5. Once a suitable calibration gas is intro-
duced, press ENTER to initiate calibration
as displayed right and disable the key
pad (to prevent the calibration routine
from being interrupted).
20.9 %
6. This display appears for sixty (60) seconds AIR CALIBRATION
OGX-1900-HC refer to section 5.4.3.
to allow the sensor to stabilize before IN PROCESS
the microprocessor takes the final reading.

14 15
7. If the calibration is successful, the display below left appears for
three (3) seconds before defaulting to the display below right:
5 Operation
5.1 Principle of Operation

20.9 %
TO SKIP 100% O2 CAL
The OGX-1900 Series Oxygen Analyzers and Monitor utilize an electrochemical
PRESS ENTER
galvanic fuel cell type oxygen sensor of the type that is extensively used to
FOR 100% O2 CAL measure oxygen concentrations from 0% to 100% in gas streams. Oxygen, the
WAIT FOR NEXT fuel for this electrochemical transducer, diffusing into the sensor through a gas
AIR CALIBRATION DISPLAY permeable membrane reacts chemically at the sensing electrode to produce an
SUCCESSFUL electrical current output proportional to the oxygen concentration in the gas
phase. The sensor has an absolute zero meaning that when no oxygen is pre-
8. The display above right requires a decision by the user (refer to sent to be chemically reacted the LCD displays 00.0 oxygen.
warnings at the beginning of this section) to press ENTER and
skip the 100% O2 calibration and return to the SAMPLING mode; The sensor’s signal output is linear over the entire range, remains virtually con-
or, wait ten (10) seconds for the following display: stant over the specified useful life and drops off sharply at the end. The sensor
itself requires no maintenance and is simply replaced at the end of its useful life
like a battery. Inasmuch as the sensor is a transducer in its own right, its ex-

20.9 %
pected life is not affected by whether the analyzer is ON or OFF.

The relationship between the sensor’s signal and changes with the oxygen
INTRODUCE 100% O2 concentration is both proportional and linear, thus allowing single point calibra-
OBSERVE TREND tion. Other factors that can affect the signal output are described in Section 5.2
PRESS ENTER TO CAL Application Considerations and Section 3 Safety Warnings which should be read
before use.
9. Repeat steps #3 through #6 using a certified source of 100% oxygen.
Historically, the expected life of galvanic fuel type sensors has been specified as
“in air (20.9% O2) at 25°C and 760mm Hg”. The actual life of any galvanic fuel

100 %
10. If the calibration is successful, the display
at right appears for five (5) seconds before type sensor is inversely affected by changes in the average oxygen concentra-
defaulting to the SAMPLING mode. tion, temperature and pressure it is exposed to during its useful life. For exam-
ple, the AII-11-60 sensor has a 60 months expected life in air (20.9% oxygen)
at 25°C and ambient pressure, however, in a 100% oxygen atmosphere the
OXYGEN CALIBRATION
expected life is 12.6 months [60mo/(100%/20.9%)].
SUCCESSFUL

Calibration Fails OGX-1900 Series Oxygen Analyzers and Monitors are battery powered by (2)
An unsuccessful calibration can be caused by AA alkaline batteries and controlled by a state-of-the-art microprocessor. The
AIR / 100% O2 CALIBRATION batteries provide enough power to operate the analyzer continuously for ap-
several problems as displayed at right: FAILED proximately 1,200 hours. Both devices utilize a membrane type keypad for
If after three (3) unsuccessful attempts to users to communicate commands to the microprocessor. The monitor is menu
- CHECK CAL GAS
calibrate: review section 8 for possible causes - CHECK CABLE driven to accommodate the alarm functions. The digital electronics provide
and corrective action or contact BC Group In- - CHECK SENSOR features such as system diagnostics, warning indicators, controls and an alarm
ternational, Inc. at 314-638-3800. RETRY - PRESS ENTER capability for continuous monitoring that enhance both safety and effective-
ness. The design criteria, quality program and performance features ensure
To abort the RETRY press ESCAPE (analyzer) or MENU (monitor). Do reliable and accurate oxygen measurements.
not proceed until the analyzer is calibration successfully.

16 17
5.2 Application Considerations The temperature dependent current signal output is compensated by using a
resistor-thermistor network. With a proper resistor-thermistor network, the
Effect of Anesthetic Agents signal can be compensated to within +5% of the oxygen reading over the 5-
The OGX-1900 Series Oxygen Analyzers and Monitors utilize an electrochemical 45°C operating temperature range. This is the worse case situation when going
galvanic fuel cell type sensor, model AII-11-60, that has been characterized by from one extreme of the operating temperature range to the other. The error
its gas permeable sensing membrane that allows the gas to be analyzed to will be eliminated when the thermistor in the temperature compensation net-
diffuse into the sensor where oxygen can be reacted. The displayed oxygen work and the electrolyte inside the sensor reach thermal equilibrium in approxi-
concentration of all sensors of this design decreases in the presence of anes- mately 45-60 minutes.
thesia gases. EN 12598:1999/ISO 7767:1997 (E) established standards for the
maximum error allowable over a given duration. The anesthetic agents listed Erroneous oxygen readings can result if the gases flowing over the
(Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurance) were vapor- sensing area of the sensor are not at ambient temperature. This occurs
ized into a gas stream of 30% oxygen / 70% nitrous oxide. because the sensor is exposed to different temperatures. The sensing
area of the sensor is o-ring sealed in the heated breathing circuit and the tem-
Gas Test Level Decrease in O2 Reading perature compensation network at the rear of the sensor is exposed to ambient
Helium 50%, Balance O2 0% temperature.
Nitrous Oxide 80%, Balance O2 0%
Carbon Dioxide 10%, Balance O2 0% Effect of Pressure
Halothane 4% <-1.5% Electrochemical sensors actually measure the partial pressure, not the percent-
Enflurane 5% <-1.5% age, of oxygen in the gas stream they are exposed to. These sensors are accu-
Isoflurane 5% <-1.5% rate at any pressure provided the pressure is constant and the analyzer has
Sevoflurane 5% <-1.5% been calibrated at the same pressure as the sample gas measured.
Desflurane 15% <-1.5%
For example, when connected to a ventilator circuit, the six (6) second T90
The errors listed were observed after a two (2) hour exposure period. The response time of the AII-11-60 Oxygen Sensor causes the analyzer to display
table above summarizes the performance of the OGX-1900 Series electronics an increase in the oxygen reading displayed when in fact the alternating
and AII-11-60 Oxygen Sensor. The above performances all meet or exceed the breathing pressure cycles generated by the ventilator is increasing the total
requirements established by EN 12598:1999/ISO 7767:1997 (E). pressure. The increase in the reading displayed is not related to a change in the
oxygen percentage but to the increase in partial pressure (corresponding to the
Do not operate any device in the presence of flammable anesthetic increase in total pressure).
agents such as Diethal Ether or Cyclpropane.
The output of the device output is not compensated for barometric pressure.
Note: The AII-11-60 Oxygen Sensor has been specifically designed and tested
to be compatible with nitrous oxide. For optimum results, mount the oxygen Calibrate at the temperature and pressure (altitude) at which the ana-
sensor with the sensing area facing down toward the floor and be flushed or lyzer will be operated.
calibrated with 100% oxygen every eight (8) hours.

Effect of Temperature Effect of Humidity

All membrane clad electrochemical sensors are temperature dependent due to The analyzer is not affected by non-condensing relative humidity (RH). How-
the expansion and contraction of the Teflon sensing membrane. As result more ever, the use of a humidifier to introduce water vapor and increase the mois-
or less of the sample gas including oxygen to be reacted diffuses into the sen- ture level of the gas mixture does affect the oxygen concentration and the
sor. The oxygen sensor’s electrical current signal output varies linearly with resultant reading displayed by the analyzer. The addition of water vapor in-
oxygen concentration. The signal also varies with changes in ambient tempera- creases the total pressure thereby diluting or decreasing the oxygen concentra-
ture. The temperature coefficient is typically 2.54% of the signal or reading per tion of the gas mixture resulting in a lower oxygen reading.
degree C change in temperature.

18 19
 Calibrate at the temperature and pressure (altitude) at which the 5.3.1 Flowing Gas Streams (Breathing Circuits)
analyzer will be operated, humidified gases cannot be 100% oxygen. 1. Place the sensing area of the sensor into the gas stream to be analyzed
upstream of any humidification equipment.
2. Assure that the flow rate of the gas stream does not exceed ten (10) liters
Effect of Condensation
per minute. Exceeding ten (10) liters per minute generates backpressure.
Excessive condensation collecting on the sensing area or the electrical connec-
tions at the rear of the sensors can adversely impact the performance of elec- 3. Check the gas stream and particularly the mechanical connection for leaks
trochemical sensors. Condensation blocks the diffusion path of oxygen into the that dilute the gas stream with ambient air.
sensor and can reduce the oxygen reading to 00.0 if the condensation covers 4. Assure there are no restrictions in the circuit downstream of the sensor
the entire sensing area. Condensation on the electrical connections at the rear that could generate backpressure on the sensor.
of the sensor can affect oxygen readings. Remedy either situation by shaking
5. Use the flow diverter supplied with the device along
out the condensation and allowing the sensor to air dry.
with the optional tee adapter and position the sen-
sor vertically for optimum results, as shown right.
Erroneously characterized in many instances as a sensor failure, excessive
The flow diverter avoids stagnation and facilitates
condensation is remedied by gently wiping away the condensation with a soft
the movement of gas to and from the sensing area
cloth or simply allowing the sensor to air dry.
of the sensor thereby producing a more accurate
measurement of the gas stream to be measured.
Measurements in humidified gas streams should be compensated for by de-
creasing the oxygen reading 0.03% for each % increase in relative humidity. 6. Install the tee-adapter in the breathing circuit.
7. Screw the flow diverter to the sensor.
8. Ensure the o-ring is lightly lubricated for ease of
Effect of Electromagnetic Radiation
entry and a tight seal between the flow diverter and
Tested over a 26 MHz to 1000 MHz electromagnetic field, the analyzer
tee adapter.
is susceptible at all frequencies tested except those between 930 and
990 MHz. 9. Insert the assembled flow diverter/sensor into the tee allowing 100%
oxygen (dry, non-humidified) to flow past the sensor at a rate of 5-8 liters
Never operate the analyzer near equipment capable of emitting high per minute.
levels of electromagnetic radiation. Do not continue to operate the 10. Once the sensing area of the sensor is exposed to the gas stream allow
analyzer if the reading becomes unstable. approximately sixty (60) seconds for the reading to stabilize and observe
the reading displayed by the LCD.
Calibration
Calibrating the analyzer or monitor during normal operation involves the same 5.3.2 Static Atmospheres (Incubators, Hoods, Oxygen Tents)
precautions and procedures as those described in Sections 4.7 Start-up Calibra- Remove the flow diverter, not needed. Failure to remove the flow diverter will
tion with the same cautions to review Sections 3 Safety Warnings and 5.2 Ap- dramatically slow the response time of the sensor.
plication Considerations.
Expose the sensing area of the sensor to the atmosphere allowing approxi-
5.3 Sampling mately sixty (60) seconds for the reading to stabilize and observe the reading
Assuming the START-UP instructions are followed and the tests are displayed by the LCD.
completed successfully the devices default to the SAMPLING mode.
If placing the entire sensor inside the controlled atmosphere review
Never operate the analyzer if the reading is unstable or if a malfunction is sus- Section 5.2 Application Consideration, Effect of Temperature.
pected. If calibration is required as indicated herein, do not proceed until the
analyzer is calibration successfully.

20 21
5.3.3 OGX-1900-HC Oxygen Analyzer (Integral Oxygen Sensor) Initially this procedure can be somewhat difficult. Care should be taken
OGX-1900-HC with its integral oxygen sensor requires connecting the ¼” tub- not to damage the case when removing the battery compartment
ing supplied (section 4.2.1 above) with the device to a ¼” hose barb attached cover.
to a pressure regulator controlling a source of gas flowing at less than 10 liters
per minute. 6.2.1 Procedure:
1. Turn the device over so the
5.4 Alarms (OGX-1900-M Oxygen Monitor): shortest raised line on the battery
The monitor is equipped with user selectable HI and LO alarm set points which compartment cover is pointing
are displayed at the bottom of the LCD. Section 3.6 describes the operation away from you.
and procedure for setting the alarms in detail.
2. Lift the tripod wire stand up and
away from the case.
3. Grasp the case with both hands
6 Maintenance and using your thumbs press down firmly on the raised lines and push the
battery compartment cover away from you.
Review Section 2 General Safety and Section 8 Troubleshooting for
4. Locate the positive (+) and negative (-) terminals on the battery.
guidelines on servicing the devices.
5. Assure the battery contacts are clean.
6.1 Serviceability 6. Align one battery’s positive (+) terminal with the corresponding (+) bat-
Do not open the main compartment of the analyzer, as it contains no service- tery symbol molded into the case.
able parts inside. Never attempt to repair the analyzer or sensor by yourself as 7. Insert the battery into the compartment.
you may damage the analyzer which could void the warranty.
8. Repeat with the remaining battery.
6.1.2 Cleaning / Reuse Instructions 9. Replace the battery compartment cover, make sure it snaps into position
Clean the device, oxygen sensor and accessories with a soft cloth dampened and is secured flush against the case. Replace the wire stand as required.
with either water or mild isopropyl alcohol solution (70% isopropyl alcohol 10. Calibrate the device after replacing the batteries.
solution in water), if necessary, before re-use. Allow the components to air-dry
after cleaning. 6.3 Oxygen Sensor Replacement
The design of the electronics is intended for only the BC Group International,
Note: The Home Care Kit is not intended for patient use, it is intended solely Inc. AII-11-60 or AII-11-60-HC Oxygen Sensors. Use of a different oxygen
for confirming the O2 concentration in Oxygen Concentrators. Accordingly, no sensor may result in an erroneous oxygen reading.
cleaning instructions apply.
NEVER - Open the oxygen sensor or probe the sensing surface, refer
6.2 Battery Replacement to Section 10 in the event the sensor should leak and someone comes
The analyzers and monitor are powered by two AA alkaline batteries with an in contact with the electrolyte from inside the sensor.
approximate life of 1,200 hours. A low battery indicator circuit monitors the
battery supply voltage and sends a signal directly to the LCD when the battery 6.3.1 Procedure OGX-1900-M and OGX-1900-A - External Sensor
voltage reaches a preset level that activates the battery symbol in the LCD. 1. Disconnect the cable from the old sensor just as you disconnect a tele-
phone jack from a wall plug.
The batteries are housed in a separate compartment located at the rear of the 2. To connect the new sensor simply find and register the male plug at the
device and are accessible by sliding the removable cover. end of the coiled cable and insert it into the mating female jack at the rear
of the sensor until it mates or snaps into place.
3. Calibrate the device after replacing the oxygen sensor.

22 23
6.3.2 Procedure OGX-1900-HC - Integral Sensor 12. Once the adapter and old sensor have been removed from the case, hold
1. Tools required: small bladed screwdriver. the label of the sensor, again grasp the square edges of the adaptor and
2. Place the device face down on a flat surface. pull – to separate the old sensor from the adaptor.

3. Remove the two (2) screws from the upper corners of the rear of the 13. Remove the new oxygen sensor from the plastic shipping container.
device. 14. Install the new oxygen sensor by reversing steps 12 through 3.
4. Move the tripod up, remove the battery compartment cover (see Battery 15. Calibrate the device after replacing the oxygen sensor.
Replacement) and remove the two (2) screws located on either side.
5. Pull the rear section up ¼”-½”, turn it over and lay it next to the other 6.4 Sensor Life Expected & Warranty
section. Considers the range of the sensor’s signal output, e.g. 3.5-5.5 mV, in meeting
6. Locate the white connector at the end of the four (4) wires running from the published specification. The overall sensor life is developed as:
the sensor (the cylinder with the white label) to the top of the PCB.
- 60 months Expected Service Life 915,420 oxygen % hours
7. With your left for finger and thumb, grasp the sides of the back end of the - 6 months Recommended Storage Life period 91,542 % oxygen hours
white connector where it is soldered to the PCB. - 2 months margin of error
8. With your right fore finger and thumb, grasp the sides of the section of
the white connector where the four (4) wires from the sensor terminate. At the specified oxygen concentration (air 20.9%), temperature (25⁰C/77⁰F)
9. Separate the connector - hold the white connector section your left hand and pressure (1 atm), expect 66 months of life whether in storage or in use.
while gently pulling and wiggling the white connector section with your
right hand until it unlocks. The warranty period of 18 months starts with the shipment date from the fac-
tory and is limited to the first claim submitted and is based on:

- 60 months Expected Service Life 915,420 % oxygen hours @ 20.9%

- Estimated exposure (24/7) to 60-70% oxygen concentration
- Marginal of error of 2 months

7 Spare Parts & Accessories

OGX-1900-A, OGX-1900-M OGX-1900-HC

10. The oxygen sensor inserts into an adaptor (identified by a round recess
with a cylindrical hose adapter in the center) that slides into grooves
molded into the side of the case.
11. Hold the rear section of the case down, grasp the square edges of the
adaptor, lift up (lift straight up so as not to strip the grooves molded into
the adaptor and case) and remove the adaptor and oxygen sensor as a
single component. HRWR-1075 Dovetail Clamp
ENCL-1052 Carrying Case

24 25
8 Troubleshooting
If the recommended corrective action does not resolve the problem return the
device to the factory for service. Symptom Corrective Action

Reading displayed by LCD

Symptom Corrective Action does not change when oxy- Replace sensor
gen level changes
Device appears to be physi- Turn device ON – if it successful passes
cally damaged START-UP TEST and calibrates – proceed. Reading does not stabilize or Relocate analyzer away source of radio fre-
fluctuates erratically quency or electromagnetic radiation emis-
No digital display when ana- Install battery sions. Tested over a 26 MHz to 1000 MHz
lyzer is turned ON Replace battery electromagnetic field, the analyzer is suscep-
Check battery polarity tible at all frequencies tested except those
Check and/or clean battery contacts between 930 and 990 MHz.
Check sensor connection
Battery symbol on LCD display Replace battery and calibrate device Check cable connection
Wait 5 minutes and repeat calibration
Install sensor Replace sensor, repeat calibration
Do not attempt to use the analyzer and
LCD display reads 00.0 Check electrical connections
return the analyzer for service.
Assure electrical connections are dry
Reading displayed by LCD
No response to keypad action Replace battery
does not change when cali- Replace sensor
Cannot turn device OFF Calibration routine in process – escape or bration control is adjusted
wait until completed Reading displayed by LCD is Check sensor connection
Place sensor on flat surface (not in your very low Check cable connection
hand), wait 5 min and repeat calibration Replace sensor
Check integrity of gas delivery system
Reading displayed by LCD Check sensor’s front o-ring seal Alarms continuously acti- None – Normal operation, confirm set points
drifts during calibration Verify calibration gas in not humidified vated Abnormal -
Remove moisture covering sensor Adjust alarm set points
Replace sensor, repeat calibration Remove moisture covering sensor
Check sensor connection
Reading climbs after calibra- Allow the sensor to stabilize for 5 minutes Check cable connection
tion in 100% dry oxygen when in 100% dry oxygen and recalibrate Check integrity of gas delivery system
exposed to air 20.9% Check sensor’s front o-ring seal
Verify calibration gas in not humidified
After calibration in 100% dry Check primary oxygen delivery device Verify flow rate is 4-5 liters per minute
oxygen, analyzer reading drifts Replace sensor that is nearing the end of Replace sensor
more than 2% over 8 hours its useful life Replace cable

26 27
9 Warranty 10 Safety Data Sheet (MSDS)
Coverage
Under normal operating conditions, the analyzer and sensors are warranted to Product name Electrochemical Galvanic Fuel Cell Oxygen Sensor
be free of defects in materials and workmanship for the period specified in the
current published specifications. To make a warranty claim, you must return the Exposure Sealed device with protective coverings, normally no hazard
item properly packaged and postage prepaid to:
Ingredients Carcinogens - none; Potassium Hydroxide (KOH), Lead (Pb)
BC Group International, Inc.
Properties Completely soluble in H2O; evaporation similar to H2O
3081 Elm Point Drive
St. Charles, MO USA Flash Points Not applicable, non-flammable
T: 314-638-3800, F: 314-638-3200
E: [email protected], W: www.bcgroupintl.com Reactivity Stable; avoid strong acids, emits fumes when heated

BC Group International, Inc. in their sole discretion shall determine the nature Health Hazard KOH entry via ingestion - harmful or fatal if swallowed;
of the defect. If the item is determined to be eligible for warranty we will repair eye - corrosive, possible loss of vision;
it or, at our option, replace it at no charge to you. If we choose to repair your skin contact - corrosive, possible chemical burn.
item, we may use new or reconditioned replacement parts of the same or up- Liquid inhalation is unlikely.
graded design. This is the only warranty we will give and it sets forth all our Lead - known to cause birth defects, contact unlikely
responsibilities, there are no other express or implied warranties. Symptoms Eye contact - burning sensation; skin contact - slick feeling
The warranty begins with the date of shipment from BC Group International, Protection Ventilation - none; eye - safety glasses; hands - gloves
Inc., is limited to the first customer who submits a claim for a given serial num-
ber which must be in place and readable to be eligible for warranty and will not Precautions Do not remove Teflon and PCB coverings; do not probe with
extend to more than one customer or beyond the warranty period under any sharp objects; avoid contact with eyes, skin and clothing.
conditions.
Action KOH Use rubber gloves, safety glasses and H2O and flush all
Exclusions Leak surfaces repeatedly with liberal amounts of H2O
This warranty does not cover normal wear and tear; corrosion; damage while in
transit; damage resulting from misuse or abuse; lack of proper maintenance;
unauthorized repair or modification of the analyzer; fire; flood; explosion or 10.1 Disposal
other failure to follow the Owner’s Manual. Oxygen sensors and batteries should be disposed of in accordance with local
regulations for batteries.
Limitations
BC Group International, Inc. shall not be liable for losses or damages of any WEEE regulations prohibit electronic products including the He-
kind; loss of use of the analyzer; incidental or consequential losses or damages; lium and environmental sensors from being placed in household
damages resulting from alterations, misuse, abuse, lack of proper maintenance; trash bins.
unauthorized repair or modification of the analyzer.
Electronic products should be disposed of in accordance with local
Service regulations.
Contact us between 7:00am and 5:30pm GMT Monday thru Friday. Trained
technicians will assist you in diagnosing the problem and determining the ap-
propriate course of action.

28 29
12 Declaration of Conformity

32
12 Declaration of Conformity

33
 BC Group International,
Analytical IndustriesInc.
Inc.

13 Quality Control & Calibration Certification

Customer: _______________________________ Date: __________

Pass Y/N
Order No. _______________________________ Initial / Date

Model: ( ) OGX-1900-A Oxygen Analyzer

( ) OGX-1900-M Oxygen Monitor
( ) OGX-1900- HC Oxygen Analyzer S/N ____________ __________

Sensor: ( ) AII-11-60 Oxygen Sensor

( ) AII-11-60-HC Oxygen Sensor S/N ____________ __________

Electronics: A-1152 Rev G PCB Assembly Main Version _________ __________

Accessories: Instructions For Use

BATT-1008 Battery, 1.5V AA (Qty 2) __________

OGX-1900 A/M:
CABL-1006 Cable, Coiled Phone Jack
FITN-1009 Blue Tee Adapter
FITN-1112-1 Flow Diverter __________

OGX-1900 HC:
TUBE-1007 1/4” Tubing 7 ft. with Adapter __________

QC Test: Expected Value Observed Value Initial / Date

LCD displays 3½ digits

Reading in air after air calibration 20.9% +0.2% O2

Reading after exposure to 100% O2 100% +1.0% O2

Reading in 100% O2 after 100% O2 calibration 100% +0.2% O2

Reading in air after 100% O2 calibration 20.9% +1.0% O2

Baseline drift over 1 hour on 100% O2 range +1.0% O2

Noise level on 100% O2 range +1.0% O2

LCD displays low battery warning Battery symbol

Overall inspection for physical defects _________

Options: P/N _____________________ Qty __________ _________

P/N _____________________ Qty __________ _________

Other: Spare Parts: P/N _____________________ Qty __________ _________

Spare Parts: P/N _____________________ Qty __________ _________

Delivery: 1 of ____ , ship by ____________ _________

33