User's Manual Part 1

1-6
IRadimed provides this document without warranty of any kind, implied or expressed, including,
but not limited to, the implied warranties of merchantability and fitness for a particular purpose.
IRadimed has taken care to ensure the accuracy of this document. However, IRadimed
assumes no liability for errors or omissions and reserves the right to make changes without
further notice to any products herein to improve reliability, function, or design.
IRadimed may
make improvements or changes in the products or policies described in this document at any
time.
Refer to section 8.7 for detailed warranty information.
1.3. Warnings and Safety Precautions
1.3.1. General
The accuracy of the measurements can be affected by the position of the patient, the patient’s
physiological condition, and other factors. Always consult a physician for interpretation of
measurements made by this monitor.
Variation in measurements may be profound and may be affected by sampling technique as
well as the patient's physiological conditions. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated and/or supplemented with additional test data. Blood
samples should be analyzed by laboratory instruments prior to clinical decision making to
completely understand the patient’s condition.
To avoid patient monitor fall, secure the monitor on a shelf or bracket outside of the 30,000
gauss magnetic field. Do not place the components of the 3880 MRI Patient monitoring system,
including pulse oximeter oPOD, ECG ePOD or accessories in any position that might cause it to
fall on the patient.
To ensure safety, avoid stacking multiple devices or placing anything on the device during
operation.
Explosion hazard: Do not use the 3880 MRI Patient monitor system including the pulse
oximeter oPOD, ECG ePOD, or accessories in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
The operator should read and thoroughly understand this manual (Part Number 1200)
completely before attempting to operate the system.
Care should be taken when using the 3880 monitor with pregnant patients to ensure that the
device specifications are appropriate for the patient’s vital signs and anatomy. This device is not
intended for use with pre-eclamptic patients.
Fetal heart rates may be detected when monitoring pregnant patients.
Do not make modifications to this system. Modifications to the monitoring system and its
components which are not authorized by IRadimed Corporation can present a hazard to the
patient or user. Do not adjust, repair, open, disassemble, or modify the 3880 MRI Patient
monitor system components, including the pulse oximeter oPOD, ECG ePOD, or accessories.
Injury to personnel or equipment damage could occur. Return the device or its components for
servicing if necessary.
Use only accessories specifically designed and approved for use with the
IRadimed 3880
system. Refer to section 9 for a complete list of available accessories.