3
Safety Warnings
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 the
environment in which the device is intended to be used.
Only trained personnel who have read, understand and agree to follow
the Instructions for Use should operate the device.
Retain the Instructions for Use for future reference.
Refer service needs to trained authorized personnel. Failure to do so may
cause the device to fail and void the warranty.
Inspect the device and accessories before operating and ensure: (a)
there is no evidence of physical damage; (b) the sensor (particularly the
sensing surface) and electrical connections are dry; and, (c) the sensor is
installed and upstream from any humidifying device for accurate calibra-
tion and oxygen readings.
Calibrate: (a) with a known source of air or dry 100% oxygen before
using each day or after 8 hours of continuous use; (b) when the temper-
ature or pressure of the operating environment changes; (c) if the oxy-
gen sensor has been disconnected and reconnected; (d) after the battery
or oxygen sensor has been replace.
Sampling flowing gas: (a) install the optional flow diverter and tee-
adapter in a vertical position as shown in Section 4.3 and (b) assure
there is a tight fit between the flow diverter and tee adapter.
Sampling static, ambient or controlled atmospheres remove the flow
diverter.
Clean the device and accessories in accordance with Section 6.1.2
.
Battery replacement Section 6.2: (a) replace the batteries within twenty-
four (24) hours of the battery symbol appearing on LCD display
and (b)
calibrate the analyzer after replacing the batteries.
Oxygen sensor installation or replacement Section 6.3: allow the new
sensor to stabilize for 15-20 minutes in ambient air before attempting to
calibrate.
Store the device by turning the power OFF and removing the batteries if
the device will not be operated for over thirty (30) days.
Attempt to repeat the procedure that caused a perceived malfunction
and refer to troubleshooting hints in Section 7 before concluding the
device is faulty. If in doubt, contact the manufacturer for assistance.
4
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.
If the reading is unstable or a malfunction is suspected.
After the battery symbol appears in the LCD display.
Near equipment capable of emitting high levels of electromagnetic radia-
tion (EMI) or radio frequency interference (RFI).
Expose the device; particularly the LCD display or sensor to sources of
extreme heat, cold or excessive sunlight beyond the device’s storage tem-
perature range, refer to Section 8 for extended periods of time.
In a gas stream with a vacuum greater than 14” water column.
Immerse the device, oxygen sensor or coiled cable in any liquid.
Outside of the parameters specified in Section 8 particularly at flow rates
greater than 10 liters per minute - the backpressure generated produces
erroneously high oxygen readings.
Calibrate: (a) with 20.9% oxygen or room air with the intent of taking
oxygen measurements at oxygen levels above 30% oxygen; (b) in a hu-
midified gas stream or atmosphere; (c) without allowing a newly installed
sensor to stabilize for 15-20 minutes in ambient air.
Attempt to sterilize, autoclave, liquid sterilize, immerse in any liquid or
expose the device or accessories to steam, ethylene oxide or radiation
sterilization.
In the presence of flammable gases.
Open the main compartment of the device, except to change the integral
oxygen sensor of the AII-3000 AHC or AII-3000 MHC Oxygen Analyzers.
Open the oxygen sensor or probe the sensing surface, refer to Section
10
in the event the sensor should leak and someone comes in contact with
the electrolyte from inside the sensor.
Operate with a cable that appears worn, torn or cracked, or, allow an
excess length of cable near the patient’s head or neck; secure it to the bed
rail or other suitable object to avoid the possibility of strangulation.
Allow the device or oxygen sensor to be serviced, repaired or altered by
anyone except trained personnel
–
failure to do so may endanger the
patient or damage the device rendering the warranty null and void.
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