USER SAFETY INFORMATION
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To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is
required to minimize harm to the patient.
This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be
employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or
other adverse reactions. Electrodes are intended for short term use and should be removed from the patient
promptly following testing.
To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
To maintain designed operator and patient safety when the optional network connection is being used, the
network cable must be connected to the device through the Ethernet isolator module provided.
To maintain designed operator and patient safety, the M12xxx-USB module and conductive portions of
antennas and cables connected to it must be positioned such that they are inaccessible during normal operation.
The quality of the signal produced by the thermal writer may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
Caution(s)
Do not use the device as a method for loading or operating commercially available software. Doing so might
affect the performance of the device.
Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning
as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild
detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to
follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to
users, patients and bystanders, or damage to the device.
No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected
inoperative equipment must be immediately removed from use and must be checked/repaired by qualified
service personnel prior to continued use.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables
should be stored after forming them into a loose loop.
The device is initially configured with the X-Scribe application running under the local administrator login.
Although it is possible to reconfigure the application to run under a standard user account, it is not
recommended and may potentially cause unintended behavior from network communication during an exam.
To ensure intended function, the application can be configured to run under a standard user that will prompt for
an administrative password. Refer to the SYSTEM CONFIGURATION section for instructions.
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