Spaulding Electrocardiograph Model 2100iQ User Manual
Safety
User Safety Information
This User Manual provides important information about the use and safety of the Spaulding Electrocardiograph Model
2100iQ ECG Device. Follow all operating procedures. Incorrect use or application of the device or ignoring specifications and
recommendations could result in increased risk of harm to users and/or patients and bystanders. Damage to the ECG device
could also occur.
Means there is the possibility of personal injury to you or others.
Means there is the possibility of damage to the device.
Provides information to further assist in the use of the device.
The ECG device is for use by qualified medical professionals, trained personnel under the guidance/order of
licensed physician. Before attempting to use the Spaulding webECG server for clinical applications, the operator
must read and understand the contents of this User Manual and other accompanying documents. Failure to do
so could result in increased risk of harm to users and patients or damage to the ECG device.
The ECG device captures and presents data showing a patient’s physiological condition that when reviewed by a
trained physician or clinician, can be useful in determining a diagnosis. However, the data should not be used as
a sole means for determining a patient’s diagnosis.
The quality of the signal produced by the ECG device may be adversely affected by using other medical
equipment, including, but not limited to, defibrillators, MRI, and ultrasound machines.
To prevent electrical interference on the 12-lead ECG, keep the patient cable and ECG device a minimum of 3
feet from any AC powered device while recording ECG data.
Device should not be used in an Oxygen rich environment.
The device is not designed for use with high frequency (HF), surgical equipment and does not provide a
protective means against hazards to the patient. Device has not been tested for magnetic resonance safety. Do
not use with MRI systems. For proper operation and the safety of users and patients, equipment and accessories
must be connected only as described in this User Manual.
The ECG device, however, may be used on patients with an implantable defibrillator. The ECG device provides
defibrillation protection only when used with a Spaulding 12-lead ECG Patient Cable. In addition, proper
placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.
The Spaulding 12-lead ECG Patient Cable includes resistors in each lead for defibrillation protection. 12-lead ECG
Patient Cables should be checked for cracks, breakage, or damage of any kind prior to use. Do not use damaged
cables, devices, or accessories.
Do not attempt to connect the Spaulding 12-lead ECG Patient Cable to any other device other than the Spaulding
ECG device.
Arrange device cables to reduce possibility of patient entanglement or strangulation.
Care should be taken to follow proper ECG cable/lead wire connection instructions. Misconnected (e.g.
swapped) lead wires can contribute to a physician misdiagnosis.
Do not attempt to modify the ECG device, as this can be unsafe for both the user and the patient.
To avoid the possibility of serious injury or death, conductive parts of the patient cable, electrodes, and
associated connections of Type CF applied parts, including the neutral conductor of the patient cable and
electrode should not be exposed to other conductive parts including earth ground.
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