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General| Brand | Mortara |
|---|---|
| Model | ELI 230 |
| Category | Medical Equipment |
| Language | English |
Details Mortara's responsibility for safety and performance based on authorized operations.
Outlines the user's duty for maintenance and preventing health hazards.
Explains how to identify the device using serial and reference numbers.
States copyright protection and proprietary information for the document.
Covers disclaimers regarding changes, warranties, and errors.
Defines the warranty period and coverage for products and consumables.
Lists conditions not covered by warranty and limitations on remedies.
Specifies the remedy for defects and Mortara's limited liability.
Explains safety symbols (Warning, Caution, Note) and general device use precautions.
Details electrical safety, grounding, and safe use with other medical equipment.
Covers FCC/Industry Canada compliance and RF exposure guidelines.
Advises on safe handling, environmental conditions, and potential hazards.
Defines symbols used on the device itself for function and warnings.
Defines symbols found on the product packaging for handling and storage.
Outlines precautions and daily inspection procedures for the device.
Detailed instructions for cleaning the device exterior, cables, and printer.
Warns against improper cleaning methods that could damage the device.
Guidance on electromagnetic emissions and the intended environment.
Details immunity standards and recommended electromagnetic environments.
Specifies recommended safe distances for RF communication equipment.
Describes the manual's purpose, scope, and intended readers.
Specifies the approved clinical uses and patient populations for the device.
Instructions for connecting AM12 or WAM acquisition modules to the ELI 230.
Steps for loading paper and connecting the device to power.
Procedures for setting date/time and configuring the WAM.
Details WAM battery, buttons, pairing, lead fail indication, and cleaning.
Explains where to find the device's model, serial, and part numbers.
Steps for patient preparation, skin prep, and electrode placement.
Process for entering patient demographic information before ECG acquisition.
Covers acquiring, selecting best 10s, printing, and storing ECG data.
Instructions for acquiring rhythm strips, and transferring/deleting ECG data.
How to access configuration menus and a summary of available options.
Explanation of specific settings like Language, Filters, Paper Speed, etc.
Guides for diagnosing issues and verifying device operation.
Advice for biomedical staff and procedures for battery/printer care.
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