Spaulding Electrocardiograph Model 2100iQ User Manual
Before use, examine the ECG device and cables for cracks, breaks or other damage. When necessary, dispose of
the Spaulding ECG device and 12-lead ECG Patient Cable in accordance with local regulations.
Do not attempt to clean the ECG device or 12-lead ECG Patient Cables by submersing into any liquid, autoclave,
or steam cleaning, as this may damage the device and accessories.
Do not use sharp or hard objects to depress the button on the ECG device. Use fingertip only.
Use care when connecting the 12-lead ECG Patient Cable and USB cable to the ECG device so that a good
connection is made and that the connector pins are not damaged or bent.
Do not pull or stretch patient cables in use as this could result in mechanical and/or electrical failures. When not
in use, make a loose loop of the 12-lead cables, taking care not to bend or twist tightly. Store the cables with the
ECG device.
Use the ECG device in a controlled environment, and store according to the published environmental
specifications.
Operating Conditions:
Ambient Temp: 5°C to 40°C
Relative Humidity: 15%RH to 93 %RH
Atmospheric Pressure: 700-1060 hPa (up to 3000 m)
Transport and Storage:
Ambient Temp: –25°C to 70°C Relative Humidity: 5 %RH to 93 %RH
Atmospheric Pressure: 700-1060 hPa (up to 3000 m)
To protect the ECG device and keep it operational, store device/accessories in a dust-free environment, non-
accessible to children or pets.
Excessive patient movement could interfere with the operation of the ECG device data collection. Ask the patient
to remain still during the ECG data collection.
Store electrodes in an airtight container and record date on container. Electrodes dry out when not stored
properly causing loss of adhesion, loss of conductivity, resulting in poor quality ECG data.
The ECG device does not require special equipment for proper use or maintenance.
The ECG device and display unit have no serviceable parts and do not require calibration as the device is
designed to be self-contained with a lifespan of 2-3 years. The worst-case tolerance of all components
used in the acquisition circuits yield measured values within IEC 60601.
Use of accessories, transducers and cables other than those specified or provided by Spaulding Medical could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and
result in improper operation.
To maintain safe and effective operation of equipment, peripheral equipment and accessories that come in
direct patient contact must comply with UL 60601-1, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-25. Use only
the equipment and accessories supplied with the device or specified/approved for use by, Spaulding Medical.
All demographic setup changes, except the “Collection Options” column impact the existing database so use
caution when making modifications. Please contact Spaulding Medical Client Services Technical Support with any
questions as changes impact the entire database for your organization.
Portable RF communications equipment including peripherals such as antenna cables and external antennas
should be used no closer than 30 cm (12 inches) to any part of the device including cables specified by the
manufacturer. Otherwise degradation of the performance of this equipment could result.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment should be observed to verify that they are operating
normally.
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