Mortara X-Scribe - Page 9

USER SAFETY INFORMATION
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Note(s)
 Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper
analysis performed by the device.
 Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
 There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
 If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,
display will indicate a lead fault for the lead(s) where the condition is present.
 As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
- Class I equipment
- Type CF, defibrillation-proof applied parts
- Ordinary equipment
- Equipment not suitable for use in the presence of a flammable anesthetic mixture
- Continuous operation
NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this unit is declared
to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with mains.
Exposed metal accessible during normal operation is double insulated from mains. Internal connections to
earth ground are functional earth.
 To prevent possible damage to the device during transport and storage (while in original packaging) the
following environmental conditions must be adhered to:
Ambient temperature: -20 C to 65 C (-4 F to 149 F)
Relative humidity: 25% to 90%, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
 Allow the device to stabilize within its intended operating environment for a minimum of two hours prior to
use. The allowable environmental conditions are as follows:
Ambient temperature: 15 C to 35 C (59 F to 95 F)
Relative humidity: 30% to 70%, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
 When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.