tommeetippee NC003 Nasal Aspirator Instructions

: June 6, 2024
: tommeetippee

Table of Contents

PARTS DESCRIPTION
INSERTING / CHANGING BATTERY
HOW TO USE
CARE AND USE
TROUBLE SHOOTING
GUIDELINES
CLASSIFICATION
EXPLANATION OF SYMBOLS
EMC DECLARATION
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS AND
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tommeetippee NC003 Nasal Aspirator Instructions

PARTS DESCRIPTION

Removable cover for disposable cups. Twist to remove
Silicone ring
On / Off button
Battery cover
Disposable cups x 25
Compartment for disposable cups
Pink silicone tip 0-3 Months
Blue silicone tip 3-12 Months
Orange silicone tip 12 Months +
Spare silicone sealing ring

Product Overview

INSERTING / CHANGING BATTERY

Slide off battery cover.
Insert 2 x AA alkaline batteries.
Slide battery cover back into position until you hear a click.
Do not use rechargeable batteries.

HOW TO USE

Clean hands before use.
Wash and Sterilise clear cover, sealing ring and aspirator tip. Disposable cup can be re-used if handwashed thoroughly between use.
Place disposable cup inside unit, position sealing ring in place then position clear cover over the top – twist to seal and lock in place.
Select the correct tip for age of baby / toddler.
Ensure baby’s mouth is open.
Place tip into baby nose. DO NOT place deeply into the nose.
DO NOT press the tip hard against the nasal wall.
DO NOT apply the device to the ear , eye or throat this product is designed to remove nasal mucus only. When using the aspirator DO NOT block baby’s other nostril.
Press “i” to operate the unit only in bursts of a few seconds.
Use for a few seconds only to remove mucus.
Turn off the device by pressing “O”.
Disassemble cover and remove disposable cup holding the nasal mucus. Dispose of mucus.
Wash, sterilise, dry the cover and silicone tip. Wash and dry the disposable cup or use replacement provided. Reassemble cover, disposable cup and silicone tip.
Wipe the main body with soft cloth. DO NOT immerse the unit in water.
Always use unit with disposable cup to collect mucus.
Always change or empty disposable cup of mucus when the cup becomes two thirds full.
Do not turn aspirator upside down when mucus is in the cup as it may block the aspirator.

CARE AND USE

When using the aspirator make sure the baby opens their mouth.

When using the aspirator do not block baby’s other nostril.

Clean the aspirator after each use.

Do not store the unit with mucus inside the disposable cup. Always clean / sterilise after each use.

Please remove batteries if the aspirator will be left unused for longer than 14 days.

Always insert silicone sealing ring correctly before each use.

Keep out of reach of children.

Do not use the aspirator if there is any wound, infection or bleeding of the nose and consult your doctor.

Only use the accessories provided with the aspirator.

TROUBLE SHOOTING

Problem	Solution
No aspiration	Check silicone sealing ring is in position Check cover is

locked and sealed into place Check Tip is correctly assembled
On / Off button not operating| Check batteries are inserted correctly Change batteries

GUIDELINES

This device complies with the EU Directive 93/42/EEC concerning medical products, and the European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility.

CLASSIFICATION

Internally powered equipment;
Type BF applied part;
IP22;
Sterilised or disinfection: Steam steriliation;
Category AP / APG equipment: N/A.
Continuous operation.

EXPLANATION OF SYMBOLS

Symbols explanation

EMC DECLARATION

The ME EQUIPMENT (NASAL ASPIRATOR) or ME SYSTEM is suitable for home healthcare and clinic environments.

WARNING: Do Not use this equipment near active HF surgical equipment or the RF shielded room of an EM magnetic resonance imaging system, where the intensity of EM disturbances is high.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the equipment NC003, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

All necessary instructions of maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE regarding electromagnetic disturbances for the expected service life. Portable and mobile RF communication equipment may affect the performance of the NC003, avoid strong electromagnetic interference when in use, such as near mobile phones, microwave ovens, etc.
Guidance and manufacturer’s declaration – electromagnetic emmissions and immunity.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS AND

IMMUNITY

Table 1

Guidance and manufacturer’s declaration – electromagnetic emmissions

Table 2

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test| IEC 60601-1-2 Test level| Compliance level
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

Electrical fast transient/burst IEC 61000-4-4|

Not applicable

|

Not applicable

Surge

IEC 61000-4-5

|

Not applicable

|

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11|

Not applicable

|

Not applicable

Power frequency magnetic field IEC 61000-4-8| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

Conducted RF IEC 61000-4-6|

Not applicable

|

Not applicable

Radiated RF IEC 61000-4-3| 10 V/m

80MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/m

80MHz – 2,7 GHz

80 % AM at 1 kHz

NOTE UT is the a.c.mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

Radiated RF IEC 61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communications equipment)

(V/m)

385| 380-390| TETRA 400| Pulse modulation 18Hz| 1.8| 0.3| 27
450| 430-470| GMRS 460 FRS 460| FM ± 5 kHz deviation 1 kHz sine| 2| 0.3| 28
710| 704-787| LTE Band 13, 17| Pulse modulation 217 Hz| 0.2| 0.3| 9
745
780
810| 800-960| GSM 800/900 TETRA 800,

iDEN 820, CDMA 850, LTE

Band 5

| Pulse modulation 18 Hz| 2| 0.3| 28
870
930
1720| 1170-

1990

| GSM 1800; CDMA 1900;

GSM 1900; DECT; LTE

Band 1,

3, 4, 25; UMTS

| Pulse modulation 217 Hz| 2| 0.3| 28
1845
1970
2450| 2400-

2570

| Bluetooth WLAN 802.11

b/g/n, RFID 2450, LTE