Spaulding Electrocardiograph Model 2100iQ User Manual
ECG electrodes could cause skin irritation; patients should be examined for signs of inflammation or irritation.
Proper clinical procedures must be utilized to prepare the skin of 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, the ECG device, and Spaulding 12-lead ECG Patient Cable
should be cleaned before and after each use. To maintain safety and effectiveness, single-use disposable
components beyond their expiration date must not be used. All electrodes and single-use cable/ electrodes sets
should be properly disposed of after use in accordance with applicable requirements. Single-use disposable
components (e.g. electrodes, patient cables, etc.) must not be reused.
The USB input and output (I/O) connector is intended for connection to only those devices complying with IEC
60601-1-1, or other IEC standards (e.g., IEC 60950) as appropriate to the device. To reduce any potential risk of
electrical shock to the patient, the ECG device is mechanically designed such that the patient connection and the
USB connection cannot be made at the same time.
To maintain designed operator and patient safety, only use equipment and accessories supplied with the device
or specified/approved for use by, Spaulding Medical, LLC.
Do not over or under-tighten connections. Do not force or modify connections/connectors.
To avoid the possibility of electrical shock, the ECG device must be charged with an IEC 60950 compliant USB
wall charger.
Failure to follow recommended cleaning procedures, or contact with unspecified cleaning materials/disinfecting
agents, could result in increased risk of harm to users, patients and bystanders, or damage to the device.
Do not operate the equipment if it has been damaged. If equipment is damaged, remove device from service and
have device repaired by qualified service personnel.
Failure to complete recommended periodic checks/operation/maintenance of equipment can result in increased
risk of harm to users and/or patients and bystanders.
Avoid the possibility of wireless device interfering with other emergency equipment; test the function in advance
to assure compatibility.
If multiple serial numbers are shown, choose the correct ECG device serial number (may only happen when
devices are paired for the first time). Incorrect choice will result in misidentification of patient information. The
serial number is found on the back of the ECG device under the bar code, the 12-character number following
S/N.
To avoid the potential of compromising patient privacy, use appropriate password security measures, avoid
sharing User Credentials, logout of applications after use, and use automated logout security features.
Verify the display unit to the correct date/time prior to use with the ECG device.
Display unit settings must accommodate local lighting conditions for readability.
The ECG device does not contain latex; however, latex allergies can be a serious, potentially life-threatening
health issue. Those who may be sensitive to latex should not use latex.
Operation of the device when user is distracted, fatigued or under the influence of alcohol/drugs can result in
increased risk of harm to users and/or patients and bystanders.
Keep device away from pets, pests, and children.
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