NE3004 - Inhaler LAICA - Free user manual and instructions

USER MANUAL NE3004 LAICA

White nasal cannula pump device with attached tubing and a clear plastic cover (no text or symbols visible)

ISTRUZIONI E GARANZIA

Type VP-D4

APPARECCHIO A PISTONE PER

AEROSOLTERAPIA

pagina 4

Instructions and warranty page 10

PISTON NEBULIZER FOR AEROSOL THERAPY

1. Main unit

2. On/off "O/I" switch

3. Compressor air connection

4. Air hose

5. Bulb hook

6. Child mask

7. Adult mask

8. Nosepiece

9. Mouthpiece

10. Nebullsing bulb

a. Bulb top

b. Bulb cover

c. Nebulisation nozzle

d. Bulb bottom

1. Air filter compartment lid

2. Air filter

3. Adapter outlet

4. Adapter

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

Il prodotto risponde ai seguent Standards: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices - Symbols to be used with information to be supplied by the manufacture Part1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010-A1:2015-A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for In vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests forirritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Dear Customer, Laica would like to thank you for the preference accorded to this product, designed according to the criteria of reliability and quality in order to meet your complete satisfaction.

IMPORTANT

PLEASE READ CAREFULLY BEFORE USE KEEP FOR FUTURE REFERENCE

The instruction manual must be considered an integral part of the product and must be kept for its entire life. If the product is transferred to another owner, its documentation must also be transferred in its entirety.

To ensure the safe and correct use of the product, the user must carefully read the instructions and warnings contained in the manual insolar as they provide important information regarding safety, user and maintenance instructions.

Should the instruction manual get mislaid or you require additional information or clarifications, please fill in the relevant form on the website: https://www.laica.it/ in the FAQ and Support section.

Intended use and scope of application: This compressor device for aerosol therapy is an effective tool for the domestic treatment of upper and lower respiratory tract diseases. The device can be used on adult and paediatric patients. It is not intended for life support nor does it provide any patient monitoring capabilities. It is compact, easy to use and built in compliance with current European legislation concerning construction criteria for the safety of electromedical devices.

KEY TO SYMBOLS

C€0197

In compliance with European legislation on medical devices

Class II

Warning! Prohibition

Caution! Read the user instructions carefully

Symbol for "Type BF applied parts"

Manufacturer Production date

Batch production number Serial

European Representation

Indicates the given product is a medical device

IP21: Protection rating for enclosures of electrical equipment, whereby the first digit indicates the protection rating against the ingress of solid foreign objects (from 0 to 6) and the second digit indicates the protection rating against the infiltration of liquids (from 0 to 8).

SAFETY WARNINGS

• Service or maintenance of the equipment is not permitted while used by patients. The patient should be an intended operator who can understand the instruction brochure and the operation of the device.
- Prior to use, ensure the product is intact and that there is no visible damage. If in doubt, contact the retailer.
- Keep the plastic bag away from children: danger of suffocation.
- This device must be used only for its intended purpose and according to the user instructions. All other types of use shall be considered inappropriate and therefore hazardous. The manufacturer shall not be deemed liable for any damage caused by inappropriate or incorrect use.
- The use and maintenance of this product is only allowed by persons aged 14 years or over (capable of reading and understanding the instructions for use), and only if properly supervised by an adult in the case of persons with reduced physical, sensory or mental capacities, or unskilled persons. Children must not play with the device.
- Keep the device away from children because it contains small parts that could be swallowed.
- This device must be used on medical prescription. For patients allergic to aerosolized drug and by patients those who may show difficulty in breathing, apnea or continuous asthma during the process of atomization, the device should be used with caution or be used under the guidance of doctors.
- Before connecting the device, make sure the mains voltage corresponds to the voltage on the plate affixed to the product.
DO NOT use the device in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide, harmful vapours, volatile substances or flammable gases, in anaesthetic or ventilator breathing circuits. DO NOT store the device where it may be exposed to noxious fumes or volatile substances.
☐ NEVER leave the device operating unsupervised. Once finished using, turn it off and unplug it from the mains.
- Handle the product with care, protect it against accidental impact, extreme temperature fluctuations, humidity, dust, direct sunlight and sources of heat.
- In the event of a failure and/or malfunction, turn off the device without tampering with it. Always contact the retailer for repairs.
- Be sure to have dry hands before connecting or disconnecting the device and when pressing the "O/I" switch.
DO NOT pull the power cord to unplug the plug from the power outlet.
DO NOT use extensions, unwind the power cord and keep it away from sources of heat.
DO NOT tamper with the power cord for any reason. If damaged, contact your retailer.

- Always use the "Oil" switch to turn the appliance off and then unplug. Disconnect the cord from the socket after use and before cleaning.

DO NOT immerse the device and DO NOT pour water or other liquids onto it.

- If the device falls in the water, do not try to pick it up. Immediately unplug it. DO NOT reuse the device after removing it from the water.

DO NOT use the nebuliser or the power plug if they are wet.

DO NOT dry the device or its accessories in the microwave.

DO NOT use or leave the device in damp places such as a bathroom, or at temperatures above 40°C. Use the device within the operating temperature humidity.

- If the device is stored for a long period of time in a place with very low temperatures, wait at least two hours before turning it on.

- Only use original accessories of the manufacturer.

- Before each use, make sure that the nebulising bulb is clean and that the parts have been assembled correctly.

DO NOT use the device if the air tube is bent.

• Make sure that the air filter is inserted correctly and that it is clean.

Do not lie down during inhalation. Do not tilt the nebulising bulb more than 45°.

Do not nebullse water. Do not use the device while sleeping or if drowsy.

During use, DO NOT cover the device with towels or blankets. DO NOT insert any objects into the air intakes of the device.

To avoid damaging the nasal mucosa, DO NOT push the nosepiece into the rear part of the nose.

• Device not suitable for use with Pentamidine.

- The nebulization characteristics of this unit differ according to the properties of medication. Especially when used with medication with high surface activity or viscosity, such as medication solubilizing agentor expectorant, the nebulization rate may be reduced. The nebulization rate may also be reduced when the temperature of medication is low.

Do not wrap the power plug around the main unit.

ACCESSORIES / COMPONENTS

1. Main unit	10. Nebulising bulb
2. On/off "O" switch	a. Bulb top
3. Compressor air connection	b. Bulb cover
4. Air hose	c. Nebulisation nozzle
5. Bulb hook	d. Bulb bottom
6. Child mask	11. Air filter compartment lid
7. Adult mask	12. Air filter
8. Nosepiece	13. Adapter outlet
9. Mouthpiece	14. Adapter

TECHNICAL SPECIFICATIONS

• Product name: Compressor nebuliser

• Commercial name: NE3004

• Installation classification and use:

- main unit: portable,

- applied part: hand-held.

- Non- AP. APG portable

• Power supply: AC 100V \~ 240V, 50/60Hz

- Power consumption: Adapter: INPUT: 100-240VAC - 50/60Hz, 0.4A max; OUTPUT: 12VDC, 1A; main unit: INPUT/OUTPUT: 12VDC, 1A

• Operating pressure: 20Kpa-80Kpa (2.9psi-11.7psi)

• Compressor flow: 4-7 V/min.

• Noise: ≤52 db at a distance of one metre

• Nebullisation flow rate: ≥0.20 ml/min.

- MMAD: ≤ 5 micron

• Temporary use: 20 min. ON / 40 min. OFF.

- Life expectancy of the product in use (used to nebulise the medicine twice a day for about 10 minutes): about 500 hours. The frequent use of the device may shorten the life expectancy of the product.

• Nebulisation cup capacity: ≤ 8 ml

- Pollution: Degree 2

• Voltage Category : CATEGORY II

- Altitude: ≤ 3000m

Conditions during operation:

- Temperature: min. 10°C - max. 40°C, with air humidity from 30% to 85% and atmospheric pressure from 700 to 1060hPa

Storage conditions:

- Temperature: min. -20°C - max. 50°C, with relative air humidity from 30% to 85% and atmospheric pressure from 700 to 1060hPa

INSTRUCTIONS FOR USE

1) Before using the device for the first time, clean it as described in the "Maintenance and disinfection" section.
2) Connect the transformer to the device and then to the power outlet, making sure the voltage is correct. 3) To insert the medicine in the bulb, turn the top counter-clockwise to release it.
4) Remove the top, make sure that the nebulisation nozzle (no.10c of the exploded diagram) is correctly attached to the bulb top (see Fig.2) and insert the medicine prescribed by the doctor into the bottom of the nebulising bulb. Do not exceed the 8ml maximum capacity.
5) After inserting the medicine, screw the top back onto the bottom, turning clockwise to secure the lid.
6) Twist and push firmly to connect one end of the air tube to the bulb and the other end into the main unit

EN

English

tube connection. Place the bulb on the bulb holder until ready to use.

7) Apply the selected accessory: mask, mouthpiece or nosepiece as prescribed by the doctor.
8) Turn on the device by pressing the "O/I" switch. Place the mouthpiece in the mouth or the mask on the face, taking care to cover the mouth and nose, or place the nosepiece in the nostrils.
9) Inhale and exhale normally during the treatment. Sit upright in a relaxed position. Do not lie down during Inhalation. Do not tilt the nebulising bulb more than 45°. Stop the inhalation if you feel sick.
10) At the end of inhalation, turn the device off by pressing the "O/l" key.
11) Remove the air tube from the bulb and from the main unit tube connection. IMPORTANT: Like most aerosol therapy devices, at the end of the inhalation treatment, a certain amount of medicine will remain in the bulb. This is perfectly normal. This amount of the medicine, also called the residual volume, cannot be atomised.
12) Empty out any residual medicine from the bulb and check air tube to ensure it is free of condensation or moisture. Clean all parts used as described in the paragraph "Maintenance and disinfection".

This device was designed for intermittent operation - 20 min On / 40 min Off. Turn the device off after 20 minutes of operation and wait another 40 minutes before performing another treatment. During use, the main unit may heat up; this is perfectly normal.

MAINTENANCE AND DISINFECTION

• Wash your hands thoroughly before cleaning and disinfecting the accessories.
• Carefully clean all of the parts and remove the medicine residues and possible impurities after every treatment. Clean and disinfect nebulising bulb, mask, mouthpiece and nosepiece after each use.
• Clean the accessories if they have not been used for a long time.
  The main unit and the air tube must be cleaned externally using a clean, damp cloth. Never clean the device under running water or by immersion. Device with housing not protected against the penetration of liquids.
• Cleaning with water: Clean all accessories in hot water, except for the air tube, and leave them to dry naturally.
• Disinfection: All of the accessories, except for the air hose, can be disinfected with commercially available medical alcohol disinfectant according to the doses and limitations indicated by the disinfectant manufacturer.
• Submerge all the accessories, except for the air hose, in the disinfectant solution for the specified period (we recommend a contact time of less than 10 seconds). Completely remove the residues of the disinfectant by thoroughly rinsing the accessories under running drinking water and allow them to air dry.
• DO NOT BOIL THE ACCESSORIES IN WATER, DO NOT sterilise with autoclaves, Ethylene Oxide (EO) gas, low-temperature plasma sterilisers or steam sterilisers.
• Cleaning the air tube: clean the external part using a clean damp cloth. To eliminate any moisture in the

air tube, connect one of the two ends to the main unit and turn the device on for a few seconds without connecting the tube to the bulb.

• Replacing the air filter: Replace the air filter when it changes colour, or has been used for more than 60 days.
• To replace the filter, lift the air filter compartment cover, remove the used filter and insert the new one. Before inserting a new air filter, always make sure that the air filter compartment cover is clean. It is NOT possible to wash used air filters. DO NOT insert cotton instead of the filters. DO NOT use the product without a filter.
• Microbial contamination: In the presence of illnesses with a risk of infection and microbial contamination, we recommend personal use of the accessories and nebulising bulb (always consult your physician).

Do not bend the air tube.

- Dry the cleaned and disinfected parts promptly, and store them in a clean place. Store the device in a cool dry area. Assemble the nebulising bulb and store it in a dry bag.

- It is recommended to check the performance of the device every 2 years or after repairs. Contact Laica service assistance (activities excluded from the warranty).

N.B. If the appliance does not resume its correct functioning despite the checks performed, contact your dealer.
TROUBLESHOOTING

Problem Possible cause How to correct
The device does not turn on.	The adapter is not connected to the power outlet.	Insert the adapter into a power outlet.
The device is on but does not nebulise or does not nebulise enough.	There is no medicine in the bulb or the amount of medicine is lower or higher than the capacity of the bulb.	Insert the medicine into the bulb, bearing in mind its capacity (maximum 8ml).
	The nebulisation nozzle was not inserted in the bulb (no. 10c).	Insert the nebulisation nozzle in the bulb as described in fig. 2
	The nebulisation nozzle is clogged.	Rinse the nebulisation nozzle under hot running water. DO NOT insert sharp objects such as needles into the nebulisation nozzle.
Problem Possible	cause How to correct
The device is on but does not nebulise or does not nebulise enough.	The nebulising bulb has not been assembled properly.	Assemble the nebulising bulb as described in fig. 3
	The nebulising bulb has been tilted too much during use.	DO NOT tilt the nebulising bulb more than 45°.
	The air tube is bent or crushed. Extend the air tube.
	The air tube is not connected properly.	Insert the two ends of the air tube properly.
	The air filter is clogged or dirty. Replace the air filter.
The device is noisier than usual.	The air filter compartment cover is not inserted correctly.	Close the air filter compartment cover correctly.
The device overheats during use.	The device is covered with towels or blankets.	Do not cover the device during use.
	The device has been used continuously for over 20 minutes.	Turn the device off after 20 minutes of operation and allow it to cool for 40 minutes.

DISPOSAL PROCEDURE (Dir. 2012/19/Eu-WEEE)

The symbol on the bottom of the device indicates the separated collection of electric and electronic equipment.

At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it referring to a specific collection centre located in your area or returning it to the distributor, when

buying a new device of the same type to be used with the same functions. If the appliance to be disposed of is less than 25 cm, it can be returned to a retail location that is over 400 m² without having to purchase a new, similar device.

This procedure of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential effects on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the same.

Caution! The wrong disposal of electric and electronic equipment may involve sanctions.

WARRANTY

This appliance is guaranteed for 2 years from the time of delivery of the goods, or another longer term envisaged by the national legislation of the consumer's residence. This provision complies with Italian and European legislation. The Laica products are designed for home use and must not be used in public venues.

The warranty only covers manufacturing defects and does not apply if the damage is caused by an accidental event, incorrect use, negligence or misuse of the product. Use only the accessories supplied; the use of different accessories may result in invalidity of the warranty. Do not open the unit for any reason; in the case of opening or tampering, the warranty is definitively voided. This warranty does not apply to parts subject to wear or to the batteries when supplied. After 2 years from delivery, or another longer term envisaged by the national legislation of the consumer's residence, the warranty expires; In this case, the technical assistance interventions will be carried out against a fee. Information on technical assistance, whether under warranty or for a fee, can be requested by contacting [e-mail].

No payment will be due for repairs or replacements of products that fall within the terms of the warranty. In the event of faults, contact the retailer. Do NOT send the appliance directly to LAICA. All the operations under warranty (including those of replacement of the product or part thereof) will not prolong the duration of the original period of warranty of the product replaced. The manufacturer declines any liability for any damage that may, directly or Indirectly, be caused to persons, property or animals as a result of the non-observance of all the requirements established in the relevant instructions manual and concerning, especially, warnings relating to installation, use and maintenance of the appliance. Laica, in its constant commitment to improving its products, is entitled to changing without any notice, in whole or in part, its products in relation to production requirements, without this entailing any liability for Laica towards its dealers. For further information: www.laica.it.

Produced by: Vapo Healthcare Co., Ltd

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

Distributed by: Laica S.p.A.

The product corresponds to the below standards: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices - Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010-A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for In vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests forirritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Guidelines and declaration of the manufacturer

1. This device must be installed and operated in accordance with the information supplied in the ACCOMPANYING DOCUMENTATION;
2. IMMUNITY TEST LEVELS for the basic safety and essential performance of ME equipment and ME systems must be selected with a view toward the high probability of maintaining basic safety and essential performance, and must be consistent with the environment of the professional healthcare structure, domestic healthcare environment and special environments - based on the intended place of use.
3. DOMESTIC HEALTHCARE ENVIRONMENT implies a residential space in which the patient normally resides, or other spaces where patients are present and which are not environments of professional healthcare structures, where healthcare operators with medical training are continuously available when there are patients. This may be for example schools, external environments, places of domicile, vehicles, hotels and pensions.
   EXAMPLE: As indicated in table 6 of the standard IEC 60601-1-2:2014 for ME DEVICES, a common cell phone with a maximum output power of 2 W has a yield of d = 3.3 m at IMMUNITY level RI 3 V/m.

1 Electromagnetic Emissions - For all EQUIPMENT and SYSTEMS

Guidance and manufacture's declaration-electromagnetic emission
The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissionsCISPR 11	Group 1 The DEVICE uses RF energy only for its internal function. Therefore, Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissionCISPR 11	Class B The DEVICE is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.
Harmonic emissionsIEC 61000-3-2	Class A
Voltage fluctuations/flicker emissionsIEC 61000-3-3	Complies

A2 Electromagnetic Immunity - For Home Healthcare Environment EQUIPMENT and SYSTEMS

Guidance and manufacture's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment - guidance
Electrostatic discharge (ESD)IEC 61000-4-2	±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air	±8 kV contact±2 kV, ±4 kV,±8 kV, ±15 kV air	Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burstIEC 61000-4-4	±2kV power supply lines	±2kV power supply lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC61000-4-5	±1kV differentail mode±2kV common mode	±1kV differentail mode±2kV common mode
Power frequency (50/60Hz)magnetic fieldIEC 61000-4-8	30A/m	30A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11	0 % UT; 0.5 cycleAt 0°, 45°, 90°, 135°, 180°,225°, 270° and 315°	0 % UT; 0.5 cycleAt 0°, 45°, 90°, 135°, 180°,225°, 270° and 315°	Mains power quality should be that of a typical commercial or hospital environment. If the user of the DEVICE requires continued operation during power mains interruptions, it is recommended that the DEVICE be powered from an uninterruptible power supply.
Conducted RF IEC61000-4-6	3Vms150kHz to 80MHz	3Vms The MANUFACTURER should consider reducing the minimum separation distance,based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation: E = 6d Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.
Radiated RIFEC 61000-4-3	10W/m80MHz to 2.7GHz	10W/m
NOTE UT is the a.c. mains voltage prior to application of the test level

ES

Español

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

EC REP

Am Schulzentrum 12, 41564 Karst, Germany

El producto cumpla las siguientes normas: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices,

MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Español

ES

Southern Unit of Third Floor, Building B. No.99

Yudai West Rd. High Tech District, Kunshan.

Suzhou, 215301, Jiangsu, P.R. China

Das Produkt entspricht den unten aufgeführten Normen: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the

manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021

- Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015=AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation

of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

DE

Deutsch

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

EC REP

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

Le produit correspond aux normes ci-dessous : 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the

manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard-Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010-A1:2015-A2:2021

- Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for fertilization, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation

of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan.

Suzhou, 215301, Jiangsu, P.R. China

EC REP

Am Schulzentrum 12, 41564 Karst, Germany

To προύν αντατοκρίνεται στα παρακάτι πρότυτα: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the

manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral

Standard: Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Ελληνικά

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301. Jiangsu. P.R. China

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

Produsul corespunde standardelor de mai jos: 93/42/EEC - 1983+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Vyrobil: Vapo Healthcare Co., Ltd

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

EC REP

Am Schulzentrum 12, 41564 Karst, Germany

Distribuuje: Laica S.p.A.

Vyrobek odpovida niže uvedeným normám: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Aplication of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices - Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing

systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Vyrobil: Vapo Healthcare Co., Ltd

Southern Unit of Third Floor. Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

Distribuuje: Lalca S.p.A.

Viale del lavoro, 10 - 36048 Barbarano Mossano (VI) – Italy

Telefón: [phone] - [e-mail] - www.laica.it - Vyrobené v Cíne

ŠTANDARDY

Vyrobok zodpoveda nižšio uvedonym normám: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017:745, EN ISO 14971 - 2019 - Medical devices Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the

manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2008/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

A termék megfelel az alábbi szabványoknak: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Southern Unit of Third Floor. Building B, No.99

Yudai West Rd, High Tech District, Kunshan.

Suzhou, 215301, Jiangsu, P.R. China

Share Info GmbH

Am Schulzentrum 12, 41564 Karst, Germany

Izplata: Lalca S.p.A.

Viale del lavoro, 10 - 36048 Barbarano Mossano (VI) – Italy

Talrunis: [phone] - [e-mail] - www.laica.it - Ražots Kina

STANDARTI

Izsträdjums atbilst turpmäk minētajiem standartiem: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation

of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

Share Info GmbH

七口 两五

Am Schulzentrum 12, 41564 Karst. Germany

Продукты отоваря на следните стандарты: 9342/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the

manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2008/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021

- Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Parengé: Vapo Healthcare Co., Ltd

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd, High Tech District, Kunshan,

Suzhou, 215301, Jiangsu, P.R. China

Gaminy's atlinka toliau nurodytus standartus: 93/42/EEC - 1993+Amd:2007 - Medical devices directives. EU 2017/745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices - Symbols to be used with information to be supplied by the manufacture Part1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation

LT

Lietuvių kalba

of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

KOLBNI PIHUSTI AEROSOOLRAVI JAOKS JUHISED JA GARANTII

Southern Unit of Third Floor, Building B, No.99

Yudai West Rd. High Tech District, Kunshan.

Suzhou, 215301, Jiangsu, P.R. China

Toode vastab allpool ositatud standarditele: 93/42/EEC - 1993+Amd:2007 - Medical devices directives, EU 2017;745, EN ISO 14971 - 2019 - Medical devices-Application of risk management to Medical devices, ENISO 13485 - 2016+A1:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes, ISO 15223-1 - 2021 - Medical devices — Symbols to be used with information to be supplied by the manufacture Prat1:General Requirement, EN ISO 20417 - 2021 - Medical devices. Information to be supplied by the manufacturer, EN 60601-1 - 2006/A2:2021 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, EN 60601-1-2 - 2015/A1:2021 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic Compatibility - Requirements and tests, EN 60601-1-6 - 2010+A1:2015+A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Performance - Collateral standard: Usability, EN 60601-1-11 - 2015+AD1:2020 - Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, EN 62366 - 2015/A1:2020 - Medical devices - Application of usability engineering to medical devices, MEDDEV 2.7.1 - 2016 - GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION-A GUIDE FOR MANUFACTURERS AND NOTIFIED, ISO 27427 - 2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components, EN ISO 10993-1 - 2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EN ISO 10993-5 - 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, EN ISO 10993-10 - 2023 - Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization, EN ISO 10993-23 - 2021 - Biological evaluation of medical devices - Part 23: Tests for irritation, ISO 18562-2 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter, ISO 18562-3 - 2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs), ISO 18562-4 - 2017 - Biocompatibility evaluation

ET

Eesti

of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate.

Suunlsed |a toot|a deklaratsloon