USER SAFETY INFORMATION
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11.
Be careful to insert the correct lead wire into the connector block with the appropriate input connector by matching
the lead wire labels to the WAM or AM12 lead labels.
Notes
1.
Local Administrator permissions are required for software installation, application configuration, and software
activation. Local User privileges are required for application users. Roaming and temporary accounts are not
supported.
2.
8-hour timeout expiration is automatically controlled by the system. Each operation that occurs (e.g. Exam
Search, Patient Search, editing exams, starting an exam, etc.) will reset the timeout start time. When there is no
interaction with the system for the timeout duration, the user is prompted to enter login information.
3.
When the server is unavailable in a distributed configuration, the client workstation will notify the user with a
prompt to proceed in Offline Mode or cancel. Scheduled orders are not available. An exam can be conducted
with manually entered demographics and will be stored locally. When the server comes available, the user is
prompted with a list of unsent exams and a selection to send exams to the modality manager database.
4.
Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper
analysis performed by the device.
5.
Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
6.
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.
7.
If an electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,
the display will indicate a lead fault for the lead(s) where the condition is present.
8.
A thick baseline presentation on the display while using the AM12 may be due to a calibration error. Review the
LED indicator on the AM12 to ensure the unit is connected, or disconnect and reconnect to the PC USB port to
re-calibrate.
9.
The WAM will automatically start flashing LEDs if the batteries have been discharged below 1.0 volts.
10.
During normal WAM/AM12 operation, the green LED will display continuously.
11.
If the WAM battery cover is opened during transmission, the device will stop transmitting. The battery must be
reinserted and the cover must be applied to resume operation.
12.
The WAM will automatically turn off (LEDs off) if the battery has been severely discharged.
13.
The WAM will automatically turn off when the electrocardiograph is powered down.
14.
The WAM will automatically turn off after being disconnected from the patient. This will happen regardless of
RScribe battery/AC power state.
15.
A thick baseline presentation on the display while using the WAM may be due to the WAM being turned off,
having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the
LED indicator and auditory advisory on the WAM to ensure the unit is turned on, has proper battery level, is
paired correctly, and is within recommended proximity of the electrocardiograph, or power cycle the WAM to
re-calibrate.
16.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
- Type CF, defibrillation-proof applied parts.
