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General| Brand | Genadyne |
|---|---|
| Model | XLR8 |
| Category | Medical Equipment |
| Language | English |
Details the regulatory safety standards the system complies with.
Explains important symbols related to safety, compliance, and device identification.
Warns against direct contact of dressing with specific anatomical structures.
Outlines standard precautions for infection control during use.
Compares continuous and intermittent therapy modes for wound healing.
Advises on actions to take if autonomic hyperreflexia occurs.
Explains how to minimize the risk of bradycardia during therapy.
Details special precautions for wounds with enteric fistulas.
Provides guidance on protecting the skin around the wound.
Identifies key physical components and user interface controls of the device.
Explains the information shown on the screen and adjustable settings.
Details the specific power adapter and cord used with the XLR8.
Shows the types of canisters (200 CC and 400 CC) compatible with the system.
Lists optional accessories like Y connectors and carrying bags.
Explains the function of each button on the device's keypad for user interaction.
Instructions for powering on the device and initiating operation.
Explains the Continuous and Intermittent therapy modes and their visual indicators.
Sets the total duration for the intermittent therapy session.
Details on setting up time and pressure cycles for intermittent therapy.
Steps for choosing between Continuous and Intermittent therapy modes.
Detailed steps for setting treatment time, up/down times, and pressures.
Alarm triggered by a leak in the dressing or canister.
Alarm indicating the battery level is critically low.
Alarm indicating a blockage in the tubing or canister.
Steps to enable or disable specific alarm notifications for customization.
Detailed explanation of the target timeout function for leakage detection.
Instructions on how to access, view, and acknowledge logged alarms.
Explains how to set the system time and adjust screen backlight settings.
Provides details about system software version, serial number, and usage.
Instructions for changing the device's display language.
Procedures and precautions for cleaning the XLR8 unit.
Instructions for returning the device and disposing of used canisters.
Details the system's compliance with electromagnetic emission standards.
Guidance on the intended electromagnetic environment for system use.
Details the compliance levels for various immunity tests.
Guidance on the recommended electromagnetic environment for immunity tests.
Details compliance levels for conducted and radiated RF emissions.
Provides recommended distances from RF transmitters to minimize interference.
Outlines the warranty terms and conditions for the product.
Lists the specific Genadyne products covered by the warranty.
Details on the vacuum pump's service life, min/max vacuum, and capacity.
Physical dimensions and weight of the XLR8 system.
Information on power input, model, battery type, and recharge time.
Specifies operating, storage, and shipping environmental parameters.
Identifies patient protection classification and listed compliance standards.
Contact details for the main Genadyne Biotechnologies US office.
Contact details for the Genadyne Canada office.
Contact details for the Genadyne Europe office.
Contact details for the EU authorized representative, Obelis S.A.
Detailed steps on how to lock and unlock the device keypad.
Instructions for clearing the device's alarm log history.
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