GIMA 33672 Spacer for Aerosol Instruction Manual

: June 9, 2024
: GIMA

GIMA 33672 Spacer for Aerosol

DL-01A (Gima 33672, 33673, 33674)

Taian Dalu Medical Instrument Co., Ltd.
West Part of Yitianmen Street, Hi-tech Zone, Taian,
271000 Shandong, P.R. China – Made in China

EC/REP Lotus NL B.V. Koningin Julianaplein 10
1e Verd, 2595AA, The Hague, Netherlands

Imported by
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com
– export@gimaitaly.com
www.gimaitaly.com

IMPORTANT INFORMATION

General

Please read these instructions for use carefully and completely. Do not discard, so you can consult them at a later date. If you fail to comply with the instructions for use, injury or damage to the device cannot be ruled out.
If symptoms persist or if your condition worsens, discontinue the application and contact your doctor imme-diately.

Information about the instructions for use

These instructions for use are intended for the user at home. A separate copy of instructions for use is available for medical specialists.

Structure of safety instructions

Safety-critical warnings are categorized according to hazard levels in these instructions for use:

The signal word WARNING is used to indicate hazards which, without precautionary measures, can result in serious injury or even death.
The signal word CAUTION is used to indicate hazards which, without precautionary measures, can result in minor to moderate injury or impair treatment.
The signal word NOTICE is used to indicate general precautionary measures which are to be observed to avoid damaging the product during use.

Treatment of babies, children and anyone who requires assistance

Babies, children and anyone who requires assistance must be supervised constantly by an adult during inhalation therapy.
This is the only way to ensure safe and effective treatment.
Individuals in this group often underestimate the hazards involved, thus result in a risk of injury.
The product contains small parts. Small parts can block the airways and lead to a choking hazard.
Therefore, make sure that you always keep all components of the product out of the reach of babies and infants.
This product is only designed for patients who are able to breathe by themselves and are conscious.
This is the only way to ensure effective treatment and avoid a choking hazard.

Hygiene
Only use the spacer and accessories that have been cleaned and dried as described in chapter 4 for inhalation therapy.
Contamination and residual moisture encourage the growth of bacteria, so increase the risk of infection.

Therefore, please observe the following hygiene instructions:

Each spacer must only be used at home by a single patient for hygiene reasons.
Make absolutely sure you also carry out cleaning and drying before using the device for the first time.
For cleaning, always use fresh tap water of drinking water quality.
Make sure all components are dried properly whenever you have performed cleaning.
Do not keep the SPACER and accessories in a damp environment or together with damp objects.

PRODUCT DESCRIPTION

Components
Check that all components of your DALU product are contained in your package.
If anything is missing, please notify the dealer from whom you purchased the DALU product immediately.

No.	Components	Specification/Size
L (Large)	C (Child)	I (Infant)
1.	Masks	√
x	√	x
x	x	√
2.	Dust cap (optional)	√
3.	Mouthpiece	√
4.	Storage body	√
5.	Back piece	√
6.	Valves	√
7.	Whistle (optional)	√

Note: “√” stands for having this components while “×” for none

Intended purpose

The SPACER is a holding chamber, and is used in conjunction with medication sprays or “metered dose inhalers” in the treatment of diseases of the airways.

Intended use

The SPACER is a holding chamber which makes it easier to in- hale from a metered dose inhaler.
Only medication that has been approved for inhalation treatment must be used. Take note of any restrictions in the instructions for use of the medication in question.
In order to ensure proper treatment, please use only DALU accessories.

Contraindications
There are no contraindications known.

Product combinations
The SPACER can be used with the following masks:

DALU infant mask (for children younger than 2 years)
DALU child mask (for children aged 2 to 4 years)
DALU adult mask (for children aged from 4 years up to adult who are unable to inhale using a mouthpiece)

Description of function
When used together with an appropriate mask, the SPACER is also suitable for use by babies and children
The SPACER helps to: minimize coordination mistakes when using metered dose inhalers avoid deposition of large quantities of medication in the oropharyngeal area, and the undesirable side effects associated therewith With a flexible connecting adaptor it can be used with all standard metered dose inhalers.

Material information

PETG/PP/ABS Inhalation chamber, Mouthpiece
Silicone Valve in the chamber, mask
Thermoplastic rubber Connecting adaptor for metered dose inhaler

Operating life

The SPACER should be replaced not more than 2 years.

INHALATION

Function check

Clear pathway through the valve
After receiving the SPACER, check that the path through the valve in the mouthpiece is unobstructed.
If the valve is obstructed, the SPACER must not be used.

Position of the valve
Before every use, check that the valve is in the correct position inside the SPACER mouthpiece:

Check that the valve is in the position shown inside the mouthpiece. If necessary, use a stream of water to correct its position.
Dry the SPACER completely before using it again.

Preparation for inhalation

WARNING
Since the inhalation chamber of the SPACER is not completely closed, small particles can get in, and might be breathed in during an inhalation session (choking hazard). Therefore, it is imperative to make sure there are no foreign bodies inside the SPACER before every use.

CAUTION
Check all product components and the accessories before each use.
Replace any broken, misshapen or seriously discoloured parts. Please also follow the instructions for assembly given below.
Damaged components and an in- correctly assembled holding chamber may impair the function of the holding chamber and thus the treatment as well.

CAUTION
If the adult mask is being used, make sure that the expiratory valve shim is pressed out.
If the valve shim is deflected inward, the dosage delivered may be insufficient when inhaling.

Performing the inhalation

Put mask on the mouthpiece of the spacer (if you have a mask). CAUTION
Before the patient starts inhaling, ensure that all parts are firmly connected to each other. Otherwise, insufficient dosage may be delivered.
Take out MDI and shake the medicine.
Put MDI into connector.
Try to exhale, and hold mask against the face, press MDI and inhale slowly. If there is not a mask, place lips around mouthpiece, press MDI and inhale slowly. Slow down inhalation if a tone is heard. Hold breath for 8-10 seconds

CAUTION
If you use a mask, make sure that the mask completely covers both corners of the mouth and the nose.
Otherwise, the treatment can be less effective due to escaping aerosol, because of underdosage, for example.
For possible side effects of escaping aerosol, please read the instructions for use of the medication in question.

CAUTION
Children younger than 18 months should inhale four to six times; children older than 18 months should inhale deeply two to four times.
Otherwise, insufficient dosage may be delivered.

For adults, one breath is enough to inhale the medication from the SPACER

Remove the spacer and expiate.
If the doctor asks you to take medicine for more than one spray, please take a rest for one minute, and then repeat step 4 and step 5.

CLEANING

Regularly clean all product components and the accessories used, if they are visibly dirty immediately after use.

Preparation

Take the metered dose inhaler out of the connecting ring on the inhalation chamber and close it with the protective cap provided for this purpose.
If applicable, detach the mask from the mouthpiece.
Disconnect the mouthpiece from the inhalation chamber (if applicable).

Cleaning

Remove the back piece and disassemble the other parts of the spacer.
Rinse in clean water.
Let air dry in vertical position.
Soak both parts for 15 minutes in lukewarm water with liquid detergent. Agitate gently.
Shake out excess water. Do not rub dry.
Replace back piece when unit is completely dry and ready for use.

Visual inspection

Inspect all product components after each cleaning. Replace any broken, misshapen or seriously discolored parts.

Drying and storage

Dry all individual parts completely.
Because of the antistatic properties of the inhalation chamber, you can dry them with a clean tea towel.
Place the protective cap over the mouthpiece (if applicable).
Info: The protective cap protects the mouthpiece from damage during transport and storage.
Attach the mouthpiece to the inhalation chamber (if applicable).
Store the SPACER and its accessories in a dry, dust-free place (safely out of continuous direct sunlight).

MISCELLANEOUS

Disposal

All product components can be disposed with domestic waste unless this is prohibited by the disposal regulations prevailing in the respective member countries.

Explanation of symbols

| Product code| __| Keep away from sunlight| | Consult instructions for use
---|---|---|---|---|---
__| Lot number| | Keep in a cool, dry place| | Date of manufacture
| Manufacturer| | Medical Device complies with Directive 93/42/EEC| | Authorized representative in the European community
| Expiration date| | Caution: read instructions (warnings) carefully| |