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General| Category | Medical Equipment |
|---|---|
| Battery Life | Up to 4 hours |
| Noise Level | 45 dB (decibels) |
| Therapy Modes | Continuous Flow |
| Power Source | AC Power, Battery |
| Alarms | Low Oxygen, Power Failure |
Crucial to consult physician and read instructions before device use.
Warnings against use in oxygen-rich environments and unauthorized modifications.
Alerts about RF interference affecting performance and heat during charging.
General description of the UNO+ NPWT device, its features, and included accessories.
Lists the types of wounds suitable for treatment with the UNO+ NPWT system.
Lists specific patient conditions where the UNO+ NPWT system should not be used.
Discusses high-risk patients for bleeding complications and monitoring requirements.
Instructions for covering exposed vessels and organs to prevent injury during NPWT.
Cautions regarding NPWT near infected vessels and potential injuries from sharp edges.
Warnings for patients on anticoagulants or using hemostatic agents.
Guidelines for monitoring infected wounds and recognizing systemic infection symptoms.
Specifies that UNO+ NPWT is not for untreated osteomyelitis.
Guidance on protecting nerves and proper foam dressing removal.
Rules for active NPWT duration and potential acrylic adhesive sensitivity.
Safety measures for defibrillation, MRI, and HBO therapy use.
Application of standard precautions for infection control.
Recommendation for Continuous Mode on unstable structures.
Considerations for patient size/weight and actions for spinal cord injury.
Avoiding bradycardia risk and protecting periwound skin.
Notes on circumferential dressing and intended user of the device.
Steps for preparing the wound and choosing the correct foam dressing size.
Detailed steps for cutting and placing the foam dressing into the wound.
Steps for covering the foam with transparent film and applying the port pad.
Procedures for attaching the canister and connecting the port tubing.
Steps to start therapy and connect the Y connector for multi-wound applications.
Steps for managing port tubing and initiating therapy for multiple wounds.
Instructions for preparing and applying foam for a bridge dressing.
Steps for applying film, hole, and port tubing for bridge dressing.
Checking seal integrity and understanding LED indicators for therapy modes.
Notes on preventing accidental setting changes and waking the unit from sleep.
How to select specific pressure levels and Continuous/Variable modes.
Methods for checking seal integrity and initial steps for leak correction.
Securing excess tubing and features of the carrying case.
Step-by-step guide to safely remove the NPWT dressing.
Guidelines for disposing of used dressings as clinical waste.
Instructions for removing and installing canisters.
Procedures for disposing of used canisters according to local protocols.
Explanation of blockage and canister full alerts and their icons.
How leaks are detected and detailed steps to correct them.
Low battery alerts and procedures when NPWT therapy is completed.
How audible alerts function and repeat until resolved.
How to use the button to temporarily silence audible alerts.
Advises periodic checks for tubing kinks or blockages.
Guidance on disposing of the device according to WEEE directive.
Steps for connecting the USB charger and cable to the unit.
Procedures for connecting the charger to a power outlet and the unit.
Details on charging time, LED indicators, and full charge status.
Note that the unit is operational while charging.
Critical warning against using unauthorized USB chargers or cables.
Caution against charging the device while it is in its carrying case.
How to lock and unlock the keypad using the SILENCE button.
Requirement for mandatory 12-month preventive maintenance.
Use damp cloth with mild disinfectant; avoid solvents/abrasives.
Warnings to prevent liquids from entering the unit during cleaning.
Instructions to clean the unit before returning it.
Proper disposal of the device, especially regarding batteries.
Disposal of used canisters according to local protocols.
Explanation of symbols like IP22 and Double Insulated.
Symbols indicating Rx Only, MR Unsafe, and Federal Law restrictions.
Symbols for fragile items, biohazard, and WEEE directive.
Declaration on RF emissions and the electromagnetic environment.
Compliance for harmonic and voltage fluctuation emissions.
Immunity test results for ESD and electrical fast transients.
Immunity to surge events and power supply variations.
Immunity to power frequency magnetic fields.
Immunity tests for conducted and radiated RF disturbances.
Recommended distances from portable RF equipment to prevent interference.
Details on operating time, battery type, and recharge time.
Information on dimensions, weight, and operating environment.
List of relevant compliance standards and regulations.
Contact details for Genadyne Biotechnologies and Obelis S.A.
Placeholder for distribution details.
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