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906-0731-04 Rev. B Sept. 2012
Page 6 of 68
WARNINGS AND CAUTIONS REGARDING USE
731Series and Pulse Oximeter
WARNING!
Electric shock hazard: Do not remove equipment covers except to replace batteries! An
operator may only perform maintenance procedures specifically described in this manual. Refer servicing
to Impact or an authorized Impact Service Center in the repair of this equipment.
WARNING!
The device is intended for use by qualified personnel only! The operator should read this
manual, all precautionary information, and specifications before using the device!
WARNING!
Possible explosion hazard if used in the presence of flammable anesthetics or other flammable
substances in combination with air, oxygen-enriched environments or nitrous oxide!
WARNING!
During operation the device should not be stacked on top of or under other medical equipment
due to the possibility of electromagnetic interference between the device and other equipment. (The
device was subjected to EMC testing in accordance with Military Mil-STD-461F and Commercial IEC 60601-
1-2 and FDA Reviewers Guidance specifications.)
WARNING!
Grounding:
Connect the device only to a three-wire, grounded, hospital-grade receptacle! The three-conductor
plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not
available, a qualified electrician must install one in accordance with the governing electrical code.
Do not under any circumstances remove the grounding conductor from the power plug!
Do not use extension cords or adapters of any type! The power cord and plug must be intact and
undamaged.
If there is any doubt about the integrity of the protective earth conductor arrangement, operate the
oximeter on internal battery power until the AC power supply protective conductor is fully functional!
WARNING!
To ensure patient electrical isolation, connect only to other equipment with electronically
isolated circuits!
WARNING!
Do not use antistatic or conductive hoses or tubing with this device!
WARNING!
Do not connect to an electrical outlet controlled by a wall switch or dimmer!
WARNING!
As with all medical equipment, carefully route the ventilator circuit hose and tubing, patient
cabling, and external power cables to reduce the possibility of patient entanglement or strangulation!
WARNING!
Do not place the device or external power supply in any position that might cause it to fall on
the patient! Do not lift the device by the power supply cord, ventilator circuit or pulse oximeter patient
cable!
WARNING!
Do not use the device, its pulse oximeter or pulse oximetry sensors during magnetic resonance
imaging (MRI) scanning! Induced current could potentially cause burns. The device and/or its pulse
oximeter may affect the MRI image and the MRI unit may affect device operation or the accuracy of the
oximetry measurements.
WARNING!
The device must be connected to a grounded AC power supply when connected to AC power.
The device and its integrated pulse oximeter are referred to as an IEC 601/F device in the summary situation
table contained in IEC-601-1-1.
WARNING!
USB Interconnection: Do not operate the device on a patient when the USB is connected to any
other device.
NOTE:
The USB interconnection does not support automatic record keeping.
WARNING!
The Impact supplied ventilator circuit’s labeling
provides the resistance and compliance values
for the circuits under normal operating conditions. If added accessories are used (e.g. humidification, filters
etc.), the operator should assure they do not degrade the performance of the device. If non-Impact circuits
are used, the operator should assure these circuits do not affect the performance of the device.
CAUTION!
Federal law restricts this device to sale by or on the order of a physician.
CAUTION!
Service is to be performed by qualified biomedical equipment technicians only.