General Warnings; Warnings For The Device; Warnings For The Patient - Eurosets COLIBRI SYSTEM Instructions For Use Manual

1.11.

GENERAL WARNINGS

1.11.1. WARNINGS FOR THE DEVICE

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This Instructions for Use Manual in paper form accompanies each COLIBRÌ System.
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The Instruction for Use Manual is also provided on Eurosets website.
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In case of incorrect visualization of Use Manual on Eurosets website, contact the technical service.
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The device must be used in accordance with these instructions. EUROSETS cannot be held
responsible for damage deriving from improper use.
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Do not use the device for any purpose other than indicated. Use of the device for any other
purposes is the responsibility of the user.
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Read these instructions together with Eurosets DISPOSABLE Centrifugal Pump instructions for use
carefully before use.
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The device is intended for use in the hospital and institutional environment where healthcare
professionals provide patient care. The device is intended for use by properly trained personnel
under the direct supervision of a licensed physician.
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Do not use the device if the package is damaged.
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The product may only be operated and monitored by qualified medical staff.
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The incorrect reuse and reprocessing can compromise the electrical safety of the device and result
in electric shock, insufficient insulation, and an unintended increase in the temperature of the
device.
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Only use the COLIBRÌ Console as the drive for the Eurosets DISPOSABLE Centrifugal Pump.
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Have a replacement set at the ready.
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Always keep 4 metal tube clamps at the ready.
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Electromagnetic interference:
Do not use the device in the proximity of equipment not sufficiently screened from
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electromagnetic
2:2014+AMD1:2020.
This device/system may cause radio interference or may interfere with operation of nearby
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equipment, and mitigation measures may therefore be necessary, such as reorienting or
relocating the COLIBRÌ System or shielding the environment.
Electromagnetic interference may lead to malfunctioning of the probes using during the
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treatment.
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Stop immediately the use of the device through the emergency switch button in case of fire/smoke
from the device.
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Durable device. Do not discard after use.
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Do not dispose of WEEE (waste electric and electronic equipment) as solid household waste but
collect it separately; the device can be returned to distributors/manufacturer. Hazardous
substances contained in electrical equipment may be carcinogenic to man if dispersed into the
environment.

1.11.2. WARNINGS FOR THE PATIENT

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The device user must always maintain full responsibility for proper perfusion and patient safety in
all procedures.
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Before using carefully read the ELSO guidelines. Respect the absolute and relative
contraindications of the ELSO guidelines. Any consequences of use on patients with absolute and
/ or relative contraindications are the responsibility of the user.
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It is the clinician's responsibility to ensure that all device settings are appropriate, even when
"automatic" features such as default alarm setting are used. Ensure the alarm limits are
appropriately set before you place the patient on the device preventing possible patient injury.
Although you can set all alarms rapidly using the default alarm function, some settings are not
appropriate under all clinical conditions.
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Eurosets recommends setting the alarms limits prior to start the procedure. If circumstances force
to use the default alarm function, verify the correctness of the settings at the earliest opportunity.
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Do not silence the audible alarm when leaving the patient unattended.
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Locate the COLIBRÌ System close to the patient.
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Check the sensor cable integrity before starting the patient treatment.
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Observe the permissible maximum values for water temperature, water pressure, blood flow and
pressure on the blood side.
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Monitor the blood temperature, the blood flow and the pump speed.
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Always ensure that the patient has a sufficiently high hematocrit and adequate blood volume.
Substitute any losses in good time by administering red blood cell concentrates and, if necessary,
physiological volume replacement solutions.
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Gently release occlusion on the blood outlet side when the pump is operating at high speed, sudden
acceleration of the blood flow may cause negative pressure at the blood inlet side which can lead
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emissions higher than those indicated in IEC 60601-1-
7