CONFORMANCE TESTING
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Communication Options Testing (as applicable)
The receiving station for modem, LAN and WLAN transmissions should be running Welch Allyn ELI-Link
software. Refer to the ELI-Link user manual for proper configuration.
Verify successful transmission of all applicable communication options by acquiring ECG records that
include the transmission method in the “Patient Name” field (such as Last Name = USBD) then subsequently
transmitting the ECG record stored to a compatible receiving device. Consult the product user manual if
needed to properly configure the communication settings for each option present on the unit under test.
Successful transmission of the test records can be verified by viewing the ECG records in the unit directory
after transmission and confirming they are marked as “transmitted” (as defined in the product user manual).
Record Results on the TDR
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USB host (USB memory device needed)
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LAN
-
WLAN
Safety Testing
If the cardiograph housing was opened for repair or inspection work, the following safety tests should be
performed in accordance with the IEC 60601-1 or IEC 62353 methods and limits.
The ELI380 is considered a Class 1 Type CF device, intended to only be utilized with the Welch Allyn
AM12 or WAM patient input modules. Defibrillation isolation from the patient is provided by the patient
input modules, which are tested separately as part of the manufacturing process (they are considered non-
serviceable devices), therefore Hi-pot testing is not required for the ELI380 cardiograph.
Earth Leakage
Enclosure Leakage
Non-conductive (fully insulated) chassis testing should be performed utilizing 200 cm2 conductive
foil or equivalent, earth ground on AC input is utilized for functional earth (not safety grounding).
Patient Leakage
Applied part – patient input (utilize Mortara AM12 patient cable)
Patient Auxiliary Current
Applied part – patient input (utilize Mortara AM12 patient cable)
