miu Care ME8202XIFU Electric Medical Grade Baby Nasal Aspirator Instruction Manual

Battery Operated
Nasal Aspirator
Instructions for Use
Fast relief for stuffy noses

ME8202XIFU Electric Medical Grade Baby Nasal Aspirator

INTENDED USE
Quickly and gently removes excess mucus for alleviation infection of upper respiratory tract.
TARGET PATIENT
Babies(0+), children, or adults who suffer stuffy nose.
TARGET OPERATOR
Adults who can follow the instructions outlined in this manual.
CONTRAINDICATIONS
Do not use the device if the patient has the following symptoms:

• Nasal bleeding or any open wound inside the nose
• Acute head, facial, or neck injury
• Coagulopathy(bleeding disorder)

Warnings

Before using this device, please do read all instructions in this manual.
Please keep this manual as it contains important information.

1. Do not allow children to play with this device because it is not a toy.
   Keep the device out of children’s reach to prevent small parts and accessories from being swallowed by them accidentally.

2. This device is to clean stutty noses; do not use it in baby’s mouth or ears.

3. Clean the device first if the accumulated volume of mucus is over the safe capacity of the mucus cup (about 4mL). Always clean and dry thoroughly before and after each use, please refer to the section of “Clean Instructions.”
   Do not reuse this device if the mucus residues already coagulate and cannot be eliectively removed from parts after proper cleaning. Do not operate the device during cleaning.

4.  Do not insert the silicone tip into the nostril too deeply.

5. Do not use it on the baby for a long time. A few seconds will be enough.

6. Do not use this device if there is any wound, symptom of inframmation, or bleeding at the nose.

7. In the case of infection, fever, nasal irritation, or hemorrhage, please stop using this device and consult your physician.

8. This device is restricted for personal use.

9. No modification of this device is allowed. Please do not attempt to disassemble the device without following the instructions in this manual.

10. Do not expose the device to dust, heat source, direct sunlight, or very high humidity level.

Battery Warnings

1. Use alkaline batteries only.
2. Only batteries of the same or equivalent type as recommended should be used.
3. Do not mix alkaline, standard (carbon-zinc), or rechargeable (nickel-cadmium) batteries.
4. Do not use a mix of used and new batteries.
5. Batteries should be inserted with the correct polarity.
6. Exhausted batteries should be removed from the device.
7. Be sure that all contact surfaces are clean before installing batteries.
8. There is a risk of explosion if the battery is replaced by an incorrect type.
9. Remove batteries if the device will not be used for a long period of time; batteries may be removed easily by poking through the holes of the battery compartment.

General Information

1. The silicone tip is the applied part.
2. Duty cycle: 30 seconds ON / 2 minutes OFF.
3. The expected service life of the device is three years under normal usage.
4. The battery life is approximately 90 minutes. Replace the batteries when the suction power becomes weak during use.
5. The device can be used immediately after being transferred from 70°C (maximum storage temperature) to 20°C (ambient temperature), or from -25°C (minimum storage temperature) to 20°C (ambient temperature) environmental conditions.

Contents

1. 1 Main Unit
2. Sizes of Silicone Tips (for adult and child)
3. Instruction Manual
4. Spare Silicone Rings

Parts Description

The ME8202X is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME8202X should assure that it is used in such an environment.

Emissions| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The ME8202X 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 emissions CISPR 11| Class B| The ME8202X is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity

The ME8202X is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME8202X should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3V rms
At 0.15-80 MHz
6V rms
At ISM & Radio
Amateur Freq.
10 V/m at 80-2700 MHz AM
Modulation with 1K Hz, 80%| Not Applicable
10 V/m at 80-2700 MHz AM
Modulation with 1K Hz,
80 %| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ME8202X is used exceeds the applicable RF compliance level above, the ME8202X should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME8202X.

Instructions for Use

1. Separate the upper cover away from the lower cover in a straight direction. Do not bend the covers by brute force as it can be slid open easily.

2. Insert 2 x 1.5V AA alkaline batteries with the correct polarity as shown.

3. Check to make sure that the two silicone rings are properly seated on the grooves. Close the covers until the “click” sound is heard.

4. Choose the suitable silicone tip based on the size of patient’s nostrils.

5. Be sure to place the silicone tip securely on the mucus cup.

6. Gently insert the silicone tip into patient’s nostril.
   Do not insert it too deeply.

7. Press the button for a few seconds to collect mucus.
   Stop pressing the button when finished using the device and then the power will be stopped. If the accumulated volume of mucus is nearly over the safe capacity of the mucus cup (about 4 mL), follow the section of “ Clean Instructions” to clean the device rst. Do not use the device if the mucus level is nearly over the opening channel (where the arrow points to on the right).

Helpful Hints

1. A small amount of saline mist may help loosen thicker mucus.
2. Block the opposite nostril for more effective suctioning if needed.

Clean Instructions

1. Be sure that the upper and lower covers are closed firmly before cleaning the device.

2. Hold the mucus cup with your thumb and index finger.

3. Remove the mucus cup from the collar

4. Remove the siicone tip from the mucus cup.

5. Remove thesilicone rings from the collar.

6. Thoroughly brush and rinse all surfaces and interior of silicone tip, mucus cup, and silicone rings. Ensure all spaces are properly deaned and no visibie residucs remain on these parts.

7. Fill a pot with clean water and boil it.
   Put silicone tip, mucus cup, and silicone rings in boiling water and stir them for 3~5 minutes. Do not leave the parts in boiling water for too long. Do not leave the pot unattended during boiling.
   Be careful not to take the parts out of the boiling water with bare hands to avoid burns.

8. Clean the collar with mild soap thoroughly for a minute. Make sure that the pillar inside the collar is thoroughly cleaned, especially the air vent.

9. Rinse the collar under the tap.

10. Dry the parts with a clean cloth, or leave them to dry completely before assembling them.

11. Reassemble all parts as shown below:

12. Be sure that all parts fit tightly together on the device.

Technical Specifications

When the accumulated volume of mucus is over the safe capacity of the mucus cup during use of the device, if you see mucus dripping out of the air vent on the back side of the collar, please follow instructions below

1. Be sure that the upper and lower covers are closed firmly.
2. Remove the silicone tip and mucus cup.
3. Have the collar immersed in clean water as shown. Press the button for 15 seconds and the inner pump will be cleaned.
4. The water flows in and out of the inner pump in the direction as shown.
5. Change the water and repeat step 3 several times if necessary.
6. Remove the device from water once the cleaning is completed. Keep pressing the button for approximately 30 seconds until the inner pump is dried.
7. Dry the collar and reassemble the parts.

Operation, Storage & Transportation Environment Information

Operation Environment| Temperature: 5°C-40°C Humidity: 15% — 90% Atmospheric Pressure: 7001060 hPa
---|---
Storage & Transportation Environment| Temperature: -25°C-70°C Humidity: S90% Atmospheric Pressure: 7001060 hPa

Applied Standards

The following standards apply to the design and manufacture of the device:

• IEC / EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC / EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC / EN 60601-1-6 Medical Electrical Equipment – Part 1-6: General Requirements for Safety – Collateral Standard: Usability
• IEC 60601-1-11 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 ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
• EN ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation

Symbols Glossary

Date of manufacture(YYYY-MM), see the date of manufacture at the bottom of the device| IP22 Protection against solid foreign objects of 12.5mm 0 and greater and protection against vertically falling water drops when enclosure tilted up to 15°
Manufacturer
Authorized representative in the European Community/European Union| This device contains recyclable electronic waste. To protect the environment, do not dispose of it in household waste, but take it to an appropriate local collection center provided in your country.
This device may be used multiple times on a single patient.

MANUFACTURER
Asia Connection Co., Ltd.
16 F-1, No.16, Jian Ba Road,
Chung Ho District,
New Taipei City, 235603 Taiwan
Advena Ltd.
Tower Business Centre, 2nd Flr.,
Tower Street, Swatar,
BKR 4013 Malta

miuCareME8202XIFU-20221110-V1

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