Safety Instructions; Device Description; Intended Use; Area Of Application And Operating Conditions - Krömker TROPIC 2.0 Instrucciones De Uso

EN
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Safety instructions

Warning!
The ventilation slots must not be blocked by objects, otherwise the device does not work properly and the
aerosol nebulization will be disturbed.
Warning, risk of infection!
In order to avoid an infection or bacterial contamination, the relevant hygiene rules must be complied with.
Observe the intended use of the bacterial filter. Always wear gloves when performing work.
Warning, risk of injury!
The heatable hose connection at the rear of the device and the patient must not be touched at the same
time.
Damages
The device must be checked for damage (housing, etc.) and safety-related faults before each use. Damaged
devices must be repaired by an authorized body before putting them back into operation. All works that
require the use of tools must be performed by the manufacturer or bodies authorized by it.
Power supply
The mains voltage must comply with the information on the rating plate. The mains plug must be
disconnected before cleaning. No fluids must penetrate into the inside of the device.
Liability
The manufacturer is not liable if the device is used for purposes other than those described in the
instructions for use or if non-original spare parts are used without authorization, nor can any warranty claims
be made. Only the manufacturer or authorized professionals are authorized to perform repair work, using
original spare parts and complying with the applicable safety measures for medical electrical equipment.
Warning, observe hygiene regulations!
Contaminated device parts can endanger the health of patients. Before commissioning, the device must be
reprocessed in accordance with the operational hygiene regulations.
Caution, functional inspection!
The user must check the functionality and suitability of the applied parts for the respective intended use as
well as their biocompatibility.
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Device description

5.1 Device description
The device consists of a washable plastic housing with interior electrical components and an attachable nebulizer
chamber. It is commissioned and controlled with push buttons.
The foot of the nebulizer chamber contains a quartz oscillator that causes the fluid in the container to nebulize due to
its high-frequency oscillations. A fan located in the housing moves the aerosol through the patient hose and into the
desired respiratory area of the patient. Prior to nebulization, the aspirated air is led through a bacterial filter.
There are three different kits for the different ultrasonic nebulizer installation options:
•
Table version:
• Wall-mounted version:
• Trolley-mounted version: The device is mounted to a trolley pole
5.2

Intended use

The ultrasonic nebulizer TROPIC 2.0 is only intended for humidifying the breathing air of spontaneously breathing
patients and for aerosol therapy. An aerosol therapy must only be carried out as directed by a medical professional.
The ultrasonic nebulizer TROPIC 2.0 is used at hospitals, medical practices, nursing homes, care homes and in the
military medical service by specifically trained specialist personnel.

Aerosol therapy must only be carried out as directed by a medical professional
5.3

Area of application and operating conditions

The medical device may be used in medical areas.
Warning, risk of explosion
This medical device is neither approved nor certified for use in areas where the oxygen concentration
may exceed 25 Vol% or combustible or explosive gas mixtures are likely to occur.
96200-xxx_00 GA USV Tropic 2.0_20160229.docx
The device is located on a table or a level and robust surface
The device is mounted on a standard rail 25x10 mm (DIN)
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