Humidifier Nebulizer Instructions for Use Edition 12

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Description of target groups The target groups may only perform the following tasks if they meet the corresponding requirements. Users Task

Requirement

Use of the product in accordance with the intended use

Specialist medical knowledge in the use of the product

Reprocessing personnel Task

Requirement

Reprocessing

Specialist knowledge in the reprocessing of medical devices

Service personnel Task

Requirement

Installation

Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices

Basic service activities

Dräger recommends arranging a service contract with DrägerService.

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Symbols Storage temperature limitation

Date of manufacture

Keep away from sunlight

For Your Safety and that of Your Patients WARNING Risk of incorrect operation and of misuse Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under Intended use. Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use. WARNING Risk due to incompatible accessories The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence. Use only compatible accessories. The accessories that are compatible with this product are listed in the order list supplied with the product.

WARNING Strictly observe the Instructions for Use of the basic device on which this medical device is used. WARNING Risk due to modifications Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage. Do not modify this product. WARNING Risk if service is not performed regularly If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage. Perform the service in accordance with the chapter "Service". Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: –

Risks that are obvious to users

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Consequences of obvious improper use of the medical device

Instructions for use Humidifier Nebulizer

English

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Potentially negative effects on patients with different underlying diseases

Overview

Medical device modification or misuse can be dangerous.

Preparation

B

Before using for the first time A

CAUTION Risk of breakage Check the medical device before use. Do not use the medical device if it is damaged.

Intended Use Device for humidifying oxygen during inhalation or insufflation therapy. Used in combination with an O2 flowmeter or O2-DigiFlow for operation with O2 cylinders or a central supply system for Oxygen.

D

C E

 Make sure that the individual parts have been disinfected/sterilized, see Page 15.

F

Only for patients with spontaneous breathing.

Assembling humidifier

Safety information G

WARNING Risk of fire Do not allow O2 connections to come into contact with oil, grease, or flammable liquids. No smoking, no open flames.

H A

WARNING Risk of breakage Make sure to install the breathing circuit without loops and kinks.

C 004

A Housing B Relief valve C Jet with O-rings D O-ring E Sealing ring F

D

Nebulizer

002

CAUTION Risk of personal injury and/or device malfunctions Magnetic fields can impair the correct functioning of the medical device and therefore endanger the patient or user. Do not use the medical device near MRI scanners.

B

G Support ring H Humidifier bottle Instructions for use Humidifier Nebulizer

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A Check that the sealing ring is in place in the housing, and that it is undamaged. B Push nebulizer onto the jet as far as it will go. C Push support ring over humidifier bottle.

 Connect inhalation device or insufflation device to the humidifier.

A Open flow valve on the O2 flowmeter or O2 DigiFlow and set the oxygen flow necessary for the patient on the device.

Functional test

B Only O2 flowmeter: Read flow on upper rim of ball.

 Open flow valve on the O2 flowmeter or O2 DigiFlow. At a flow of 5 L/min the nebulizer produces a fine mist.

D Fill humidifier bottle up to mark with distilled water.  Screw the humidifier bottle into the housing.

 The nebulizer produces a fine mist.

Shut down

Operation

Assembling humidifier to O2 flowmeter or O2 DigiFlow

 Close flow valve on the O2 flowmeter or O2 DigiFlow.

NOTE Use the medical device only within the specified pressure range and environmental conditions. Observe section "Technical Data". Otherwise, the correct functioning of the medical device may be compromised.

Observe the relevant Instructions for Use of the O2 flowmeter or O2 DigiFlow.  Check that the sealing ring is in place on the O2 flowmeter or O2 DigiFlow.  Close the flow valve on the O2 flowmeter or O2 DigiFlow.

 Remove inhalation device or insufflation device.

Stripping down

 Screw humidifier to O2 flowmeter or O2 DigiFlow and tighten.

D

Inhalation/Insufflation device B C

003

005

006

A

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Instructions for use Humidifier Nebulizer

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A Disconnect humidifier bottle and empty.  Disconnect O2 flowmeter or O2 DigiFlow from housing. B Remove nebulizer. C Remove support ring from humidifier bottle. D Disconnect jet

Reprocessing WARNING Risk due to inappropriately reprocessed products Reusable products must be reprocessed, otherwise there is an increased risk of infection. – Follow the infection prevention policies and reprocessing regulations of the healthcare facility. – Follow the national infection prevention policies and reprocessing regulations. – Use validated procedures for reprocessing. – Reprocess reusable products before using them for the first time. – Reprocess reusable products after every use. – Observe the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing devices.

CAUTION Risk of stress cracking Do not use disinfectants or cleaning agents containing alcohol.

Reprocessing Procedure

Rinse items under running water until cleaning agent residue is no longer discernible.

4

Check parts for visible dirt and damage. If necessary, repeat manual cleaning.

Manual disinfection

Testing of procedures and agents

Manual disinfection should preferrably be carried out with disinfectants based on aldehydes or quaternary ammonia compounds.

The cleaning and disinfection of medical products has been tested with the following procedures and agents. The following agents showed good material compatibility at the time of the test:

Observe the applicable country-specific listings for disinfectants. The list of the German Association for Applied Hygiene (Verbund für Angewandte Hygiene VAH) applies in German-speaking countries.

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Manual cleaning: Neodisher LM2 by Dr. Weigert

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Manual disinfection: Korsolex extra by Bode Chemie

The composition of the disinfectant is the responsibility of the manufacturer and can change over time.

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Machine cleaning: Neodisher MediClean by Dr. Weigert

Strictly observe the manufacturer’s information on the disinfectant.

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Machine disinfection: thermal disinfection at 93 °C (199.4 °F), 10 minutes

Carry out manual disinfection

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Sterilization: hot steam sterilization at 134 °C (273.2 °F), 5 minutes, fractional vacuum

1

Immerse items in disinfectant. Use suitable brushes.

2

After contact time, rinse items under running water until disinfectant residue is no longer discernible.

3

Check parts for visible dirt and damage. If necessary, repeat manual disinfection.

4

Thoroughly shake out residual water. Allow items to dry thoroughly.

Manual cleaning Manual cleaning should preferrably be carried out under running water or with commercially available cleaning agents based on mild alkaline compounds. Carry out manual cleaning

Cleaning and Disinfection

1

 Clean O2 flowmeter or O2 DigiFlow, inhalation device and insufflation device following the relevant Instructions for Use.

Wash off visible soilings under running water. Using an ultrasound cleaner improves cleaning results.

2

Use cleaning agents in accordance with the manufacturer’s instructions. Make sure that all surfaces to be cleaned can be efficiently reached. Use suitable brushes.

Instructions for use Humidifier Nebulizer

3

Machine cleaning and disinfection Use a washer-disinfector in accordance with EN ISO 15883, preferably with a cart for anesthesia and ventilation accessories, for automatic cleaning and disinfection of breathing-gas conducting parts.

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Carry out machine cleaning and disinfection

Visual inspection

Service

1

Strictly observe Instructions for Use of washerdisinfector.

2

Position items so that all interior spaces are completely flushed and water can drain off freely.

 Inspect all items for damage and wear, e.g. cracking, embrittlement or pronounced hardening, and residual soiling.

Safety information

3

Use suitable cleaning agent.

CAUTION

4

Select suitable program (preferably anesthesia program).

Even accessories designed to be reused have a limited service life. Handling and reprocessing can increase wear and markedly shorten service life (e.g., disinfectant residues can attack the material more intensely during autoclaving). If signs of wear become visible, such as cracks, deformation, discoloration, peeling, etc., affected accessories must be replaced.

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Cleaning must be carried out at 40 °C to 60 °C (104 °F to 140 °F) for at least 5 minutes.

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Thermal disinfection must be carried out at 80 °C to 95°C (176 °F to 203°F) and with corresponding contact time.

5

Carry out final rinsing with deionized water.

6

Immediately remove items from the washerdisinfector.

7

Check parts for visible dirt and damage. If necessary, repeat program or carry out manual cleaning and disinfection.

8

Allow items to dry thoroughly.

Sterilization During sterilization, living microorganisms are removed from semi-critical medical devices. Residual water inside the components is also dried out.

WARNING

Disposal of the Medical Device When disposing of the medical device:  Consult the relevant waste disposal company for appropriate disposal.  Observe the applicable laws and regulations.

Risk due to inappropriately reprocessed products The product may be contaminated with infectious agents. Before service is performed and before the product is sent back for repair, reprocess the product in accordance with the chapter "Reprocessing". WARNING Risk if service is not performed regularly Wear and material fatigue of the components may lead to device failure and malfunctions. Perform service at the specified intervals. WARNING Risk if service is not performed properly Personal injury and property damage may occur if service is not performed properly. Service must be performed by those target groups that are assigned to the particular measure.

 Only sterilize cleaned and disinfected items. Use a vacuum steam sterilizer (in accordance with DIN EN 285), preferably with fractional vacuum.

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Instructions for use Humidifier Nebulizer

English

Definition of service terminology

Fault-Cause-Remedy

Concept

Definition

Fault

Cause

Remedy

Operating principle

Venturi nebulizer

Service

All measures (inspection, repair) intended to maintain or restore the functional integrity of a product

No aerosol

No distilled water

Re-fill with distilled water

Drive gas

Oxygen (O2)

Operating pressure

5 ±0.5 bar

No oxygen

Check oxygen supply

Gas consumption

5 to 15 L/min

Push nebulizer onto housing as far as it will go

Average droplet size

 1 µm

Nebulizing rate at 15 L/min  36 g/h O2

Inspection

Measures intended to determine and assess the current state of a product

Repair

Measures intended to restore the functional integrity of a product after a failure

Nebulizer not attached properly Leak in humidi- Loose fier humidifier bottle

Inspection .

Measure

Interval

Target group

Functional test and visual inspection

Service personSame as for connected ba- nel sic device (O2 flowmeter, O2 DigiFlow)

Insufficient humidification

Repair Dräger recommends that all repairs are performed by DrägerService and that only authentic Dräger repair parts are used.

Instructions for use Humidifier Nebulizer

"Heavy" droplets

Technical Data

Tighten bottle properly

Sound level at 15 L/min

50 dB (A)

Connecting thread

M 34 x 1.5

Distilled water volume

220 mL

Dimensions

Ø 59 mm Height 198 mm

Faulty sealing ring

Replace sealing ring

Loose hose connection

Connect hose properly

Defective sealing ring on O2 flowmeter

Replace sealing ring, or use new nebulizer.

Materials used

Loose fitting at connection

Weight without distilled water 230 g

Humidifier bottle

Polysulfone

Nebulizer

Polysulfone

Tighten fitting at connection

Housing

Polyamide

Blockage of jet on nebulizer

Replace nebulizer

Ambient conditions

Pressure of drive gas too low

Ensure pressure of 5 bar

Leak in nebulizer

Check O-ring Fit nebulizer properly

During operation Temperature

5 °C to 40 °C (41 °F to 104 °F)

Ambient pressure

700 to 1200 hPa (10.2 to 17.4 psi)

Relative humidity

0 to 95 %, no condensation

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During storage and transport Temperature

–20 °C to 70 °C (–4 °F to 158 °F)

Ambient pressure Relative humidity

Order List

Designation

Designation

Part No.

800 to 1200 hPa (11.6 to 17.4 psi)

Humidifier nebulizer

2M85835

0 to 95 %, no condensation

O2 flowmeter 16 L/min, hose, DIN ISO

MP04573

O2 flowmeter 16 L/min, rail, NIST

MP04567

O2 flowmeter 16 L/min, central supply, DIN

MP04558

O2 flowmeter 32 L/min, central supply, DIN

MP04571

O2 double flowmeter 16 L/min, central supply, DIN

MP04560

O2 flowmeter 16 L/min, central supply, DIN, long

MP04561

O2 flowmeter 16 L/min, rail, 90°, NIST

MP04570

DigiFlow O2, central supply, 3 L/min, M34x1.5 DIN

MP01211

DigiFlow O2, rail, 3 L/min, M34x1.5 NIST

MP01213

DigiFlow O2, central supply, 16 L/min, M34x1.5 DIN

MP01227

DigiFlow O2, rail, 16 L/min, M34x1.5 NIST

MP01229

Hose (reusable)

8403896

Class II a Classification as per Directive 93/42/EEC Annex IX UMDNS-Code 10 - 046 Universal Medical Device Nomenclature System – nomenclature for medical devices

Accessories required for operation

Part No.

Spare parts Housing

2M85827

Relief valve

2M85829

Jet with O-rings

2M85472

O-ring

E20566

Sealing ring

2M85854

Nebulizer

2M85473

Set of spare parts for the nebulizer

2M85470

Support ring

M12159

Humidifier bottle

2M85675

The humidifier nebulizer is also compatible with the O2Star oxygen therapy accessories of Dräger. For further information contact Dräger.

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Instructions for use Humidifier Nebulizer