Related Manuals for ELMASLAR CN04
Summarization of Contents
GENERAL INFORMATION
NEBTIME COMPRESSOR Nebulizer has been developed for the purpose of using of drugs in aerosol form converting from liquid form.
Device purpose: converting liquid drugs into aerosol form using an oil-free air compressor for inhalation.
IMPORTANT WARNINGS
Please read carefully a-z of the user manual of the device before using it.
Crucial to read the entire user manual thoroughly before operating the device for safe and effective use.
Prevent children from interfering the device.
Ensures child safety by preventing unsupervised access and potential misuse of the nebulizer.
Do not pour water on the device.
Safety caution to prevent electrical hazards and device damage from water exposure.
INSTALLATION
Please control the packet and device on arrival.
Inspect the package and device for any damage immediately upon receiving it.
Place the device on firm and plan surface and connect with 220 - 230 V AC electrical line.
Instructions for correct device placement on a stable surface and connection to a power outlet.
INTENDED USE OF THE DEVICE
Aerosol therapy is used to relieve breathing and support treatment in lung diseases that cause shortness of breath.
Device's primary function is aerosol therapy for breathing relief and treatment support in respiratory illnesses.
SIDE EFFECTS
The compressor nebulizer device has no direct contraindications.
States the device itself has no contraindications; contraindications may apply to the prescribed medications.
PATIENT POPULATION
Patients over 2 years of age and more than 10 kg with severe respiratory distress and treatment.
Defines the target user group: patients over 2 years old, weighing over 10kg, with severe respiratory distress.
CONTRAINDICATIONS
This product should be used on patients who are unconscious or unable to breathe spontaneously.
Specifies contraindications: not for patients who are unconscious or cannot breathe spontaneously.
USING
Run the device by pressing the off/on switch.
Simple instructions to start the nebulizer by pressing the power button.
Shutdown the device using off/on switch once not is use and unplug the power cable from socket.
Procedure to safely turn off the device and disconnect it from the power source after use.
It has been recommended to use a new aerosol chmaber for fresh use.
Recommendation for optimal hygiene and performance: use a new aerosol chamber for each treatment.
Most of the electronic devices affected by radio frequency (parasite); be careful when using a mobile comunication device around the device.
Warning about potential interference from mobile devices; advises caution when using them near the nebulizer.
MAINTENANCE AND CLEANING
Please be sure that the device has been switched off and the power cord has been unplugged before proceed for maintenance and cleaning of the device.
Essential safety step: always power off and unplug the device before performing any maintenance or cleaning.
Each time before using the device disinfect the outer surface of the device, collection jars and lids using medical disinfectant.
Procedure to disinfect the device's exterior, collection jars, and lids with a medical disinfectant.
Pull out the air filter from the edvice. Replace it with a new one and put in it's place.
Instructions for replacing the air filter to maintain device efficiency and air quality.
BREAKDOWN
Please inform authorised technical service once you face any malfunctioning of the device.
Guidance for troubleshooting: contact authorized technical support for any operational issues.
TECHNICAL SPECIFICATIONS
AVERAGE NEBULIZING SPEED
Specifies the average rate at which the nebulizer converts liquid medication into aerosol.
PARTICLE SIZE
Indicates the size distribution of the aerosol particles produced by the device.
MMAD
Mean Aerodynamic Diameter: a specific measure of aerosol particle size.
CHAMBER CAPACITY
The maximum volume of liquid medication that can be held in the nebulizer chamber.
NOISE LEVEL
Measures the sound intensity generated by the compressor during operation.
VOLTAGE/CURRENT
Details the electrical power requirements for the device's operation.
AIR FLOW
Specifies the volume of air moved by the compressor per unit of time.
AIR PRESSURE
Indicates the pressure generated by the compressor to create the aerosol.
WEIGHT
Provides the total mass of the nebulizer device.
RUNNING CONDITIONS
Defines the optimal environmental conditions for the device's operation.
STORAGE CONDITIONS
Specifies the recommended environmental parameters for storing the device.
ELECTRICAL SAFETY
Information on the device's compliance with electrical safety standards.
CERTIFICATES
Lists the certifications and approvals the device has received.
LIST OF ACCESSORIES
1 Pc Nebulizer Set
Refers to the main set of accessories provided with the nebulizer.
(1 air cannula, 1 adult mask, 1 pediatric mask, 1 mouth apparatus, 1 T apparatus & 5 pcs. Spare air filters, 1 nebulization cup.)
Detailed list of all components included in the nebulizer accessory kit.
TERMS OF GUARANTEE
Guarantee period commences form the date of deliver of the product to client.
Warranty period begins on the date the product is delivered to the customer.
If the product is broken under the guarantee period fixation period is added to the guarantee.
Repair duration is added to the warranty period if the product fails during the guarantee term.
If you have a complaint, please take the complete device to your specialist dealer or send it to us in the original packaging, postage paid and include the warranty certificate with the specialist dealers stamp.
Procedure for lodging a complaint and returning the device for service or repair.
Damages arising from improper use of the device are not covered by this warranty.
Warranty does not cover damages resulting from incorrect or improper use of the device.
This warranty will be invalidated if the unit is interfered with by unauthorised persons.
Warranty is void if unauthorized individuals tamper with or attempt to repair the device.
Breakdowns emerged subject to matters contrary to the user guide are excluded from the terms of guarantee.
Malfunctions caused by not following user manual instructions are not covered by the warranty.
Warranty is conditioned on the acceptance of these terms and conditions.
The warranty is valid only upon agreement and acceptance of all stated terms and conditions.
Consumable parts are not covered under warranty.
Parts considered consumable, such as filters or masks, are excluded from warranty coverage.
GLOSSARY OF SYMBOLS
CAUTION CONSULT ACCOMPANYING DOCUMENTS
Symbol indicating the need to refer to the user manual or other accompanying documents for critical information.
DATE OF MANUFACTURE
Symbol denoting the date when the product was manufactured.
CLASS II EQUIPMENT
Indicates the device meets Class II electrical safety standards.
IPX1 AGAINST VERTICALLY FALLING DROPS
Symbol signifying protection against water dripping vertically onto the device.
TYPE B
Denotes the type of applied part for electrical safety classification.
CONFORMITE EUROPE
CE Mark indicating compliance with EU safety, health, and environmental protection standards.
THIS SIDE UP
Symbol instructing handlers on the correct orientation for lifting and carrying the package.
FRAGILE, HANDLE WITH CARE
Indicates that the package contains fragile items and requires careful handling.
NOT MOVED WITH HOOK
Symbol advising against using hooks for lifting or moving the package.
SHOULD BE DISPOSED ACCORDING TO WEEE DIRECTIVES
Symbol indicating that the product must be disposed of in accordance with WEEE environmental regulations.
CERTIFICATES
CE 1984
Indicates conformity with European Union directives (CE mark).
ISO 9001:2015
Certification of the Quality Management System according to ISO 9001:2015 standards.
ISO 13485:2016
Certification of the Quality Management System for Medical Devices according to ISO 13485:2016.
Notified Body Kiwa Belgelendirme Hizmetleri A.Ş.
Identifies the Notified Body (Kiwa) that certified the device's conformity.
ELECTROMAGNETIC COMPATIBILITY (EMC) DECLARATION
This equipment generates, uses and can radiate radio frequency (RF) energy.
Statement on the equipment's RF energy generation, usage, and potential radiation.
GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS
Guidance and manufacturer declarations concerning electromagnetic emissions from the device.
GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY
Guidance and manufacturer declarations regarding the device's electromagnetic immunity.
Electromagnetic environment - guidance
Provides recommendations on suitable electromagnetic environments for optimal device operation.
Not 1: 80 MHz and 800 MHz, the higher frequency range applies.
Clarification on which frequency range to use for separation distance calculations.
Recommended separation distances between portable and mobile RF communications equipment and the device
Essential safety guidelines for minimum distances between the device and RF equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer.
Method to calculate required separation distances for transmitters not detailed in the standard tables.
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