DEHAS Quality Mix High Flow Manual de usuario

Operating Instructions

Quality Mix

Air-Oxygen Mixer

Quality Mix High Flow (illustrated with flow meters)

Quality Mix Low Flow

Save these instructions!

0482

DEHAS Medical Systems GmbH

Wesloer Strasse 112

23568 Lübeck, Germany

Tel: (+49) 451 80904-0

Fax: (+49) 451 80904-111

www.DEHAS.de

Table of Contents

1. Explanation of the key abbreviations............................................................................ 2

2. Safety information –Warnings, precautions and identification

information.............................................................................................................................. 2

3. Contents of delivery; Inspection upon receipt .......................................................... 4

4. Intended usage...................................................................................................................... 5

5. Before initial usage .............................................................................................................. 5

6. Technical specifications ...................................................................................................... 7

7. Pressure drop in the system............................................................................................. 8

8. Transportation and storage conditions......................................................................... 9

9. Dryness and composition of the supply gases .......................................................... 9

10. Illustrations and identification of components .......................................................... 9

11. Installation ............................................................................................................................ 12

12. Alarm test .............................................................................................................................. 12

13. Initial use ............................................................................................................................... 13

14. Cleaning / disinfection ...................................................................................................... 14

15. Maintenance.......................................................................................................................... 15

16. Product returns.................................................................................................................... 16

17. Disposal .................................................................................................................................. 16

18. Troubleshooting................................................................................................................... 17

19. Warranty conditions........................................................................................................... 18

20. Part numbers........................................................................................................................ 19

Status: 03/2022

1. Explanation of the key abbreviations

FIO2

Fractional concentration of inspiratory oxygen

DISS

Diameter Index Safety System

NIST

Non-Interchangeable Screw Thread

Bar

Measurement unit for pressure

l/min

litre per minute

2. Safety information –Warnings, precautions and

identification information

Symbol

Description

This symbol indicates that the device complies with the

regulation 93/42/EEC concerning medical devices and all

applicable international standards.

WARNING

Indicates a potentially hazardous situation which, if not

avoided, could result in death or serious injury.

CAUTION

CAUTION is used to indicate a potentially hazardous

situation which, if not avoided, may result in property

damage.

Refers the user to the necessity of consulting the

operating instructions.

Follow the instructions!

DO NOT USE OIL

Shows the serial number of the manufacturer so that a

certain medical product can be identified.

Shows the order number of the manufacturer so that

the medical product can be identified.

Medical device

UDI Barcode

Non-sterile

Date of manufacture

Show the manufacturer of the medical product according

to the EU guidelines 90/385/EEC, 93/42/EEC and

98/79/EC.

Shows a medical product that should not be used if the

packaging is damaged or opened

Describes a medical product that must be protected

against humidity.

Describes a medical product which can break or be

damaged if not handled with care.

Describes the temperature limit values that the medical

product can be safely exposed to.

Describes the humidity range that the medical product

can be safely exposed to.

Describes the atmospheric pressure range that the

medical product can be safely exposed to.

EU Authorised Representative

3. Contents of delivery; Inspection upon receipt

Contents of the delivery: 1 Base mixer along with any additional components

specified for your order

1 Operating instructions

Inspection: Take the device out of its packaging and inspect it for

damage. Do NOT use the device if you find any

damage. Contact your retailer.

4. Intended usage

The air-oxygen mixer Quality Mix is used to administer a continuous, precise mix

of medical air and medical oxygen –through its outlet ports –to infants, children

and adults. The exact fractional inspiratory oxygen concentration (FIO2)

corresponds to the selected FIO2setting on the control knob (dial).

Indication: This device should be used for patients who find it difficult to get

sufficient oxygen from the ambient air.

Contraindications: This device should not be used for patients who cannot breathe

on their own. Do not use for life support or life saving

procedures.

5. Before initial usage

Read all instructions before use!

These operating instructions are intended to show trained professionals how to

install and operate the Quality Mix. They promote safety and protect your device

from damage. If you do not understand information or instructions in this

document, do not use the device and contact your supplier.

DANGER

This product is not intended for use as a life-sustaining or life-supporting device.

WARNING

The air-oxygen mixer should only be operated by trained medical

professionals under the direct supervision of a licensed physician.

Use this air-oxygen mixer only for the purpose described in these

instructions.

Check the prescribed dose before administering to patients. Monitor the

flow frequently.

The air-oxygen mixer may only be serviced by a qualified service

technician.

Always follow the EN and DIN standards pertaining to medical gas

products, flow meters and oxygen handling.

The oxygen concentrations can optionally be confirmed using an oxygen

analyser/monitor.

The accuracy of the oxygen concentration can be affected if the bleed

flow is not activated at flow settings below 15 l/min for High Flow mixers,

and at 3 l/min for Low Flow mixers.

Do NOT interfere with or disable the alarm.

Do not use the mixer when the alarm sounds.

Do NOT use oil in or near the mixer.

Do NOT obstruct or block the bleed port at the auxiliary outlet of the

mixer.

Do NOT use the mixer near flames, flammable/explosive substances,

vapours or gases.

NEVER smoke in an area where oxygen is being used.

The rotary dial for the oxygen concentration cannot be rotated 360

degrees. Turning the dial to less than 21% or more than 100% oxygen

will damage the mixer.

CAUTION

Close the gas supply line whenever the air-oxygen mixer is not being used.

Store the air-oxygen mixer in a clean, dry place when it is not in use.

The air-oxygen mixer contains NO magnetic, ferrous materials; it can be

used with MRIs (max. 3 Tesla). A distance of 2 metres must be adhered to.

The O2 monitor cannot be used with MRIs as an accessory part.

CAUTION

Make sure that all connections are secure and tight.

Avoid excessive pressure surges of more than 6.5 bar whenever the

mixer's inlets are pressurized.

Do NOT sterilise.

Do NOT immerse in liquids.

Do NOT sterilise with Ethylene Oxide (EtO).

Do NOT use if dirt or contaminants are found on or near the mixer or its

connectors.

Do NOT clean with aromatic hydrocarbons.

The supply's inlet pressure must correspond to the value specified on the

mixer.

When using bottled gas or a high-pressure gas source, always use a

pressure reducer to maintain the pressure range between 3.2 and 6.5 bar.

6. Technical specifications

High Flow with high flow

capacity

Low Flow with low flow

capacity

Main outlet of flow

15 –120 l/min

3 –30 l/min

Auxiliary outlet of flow

with bleed

0 –105 l/min

0 –27 l/min

Auxiliary outlet of flow

without bleed

15 –120 l/min

3 –30 l/min

Bleed flow

≤ 13 l/min at 3.4 bar

≤ 3 l/min at 3.4 bar

Maximum combined

flow (of all outlets)

≥ 120 l/min

≥ 30 l/min

Emergency flow

(malfunction of air or

oxygen supply)

> 85 l/min

> 15 l/min

Applies to both High Flow and Low Flow

Alarm sounds when

supply pressure drops

Alarm on at a pressure difference between both gasses of

0.9 –1.8 bar.

Alarm off at a pressure difference between both gasses of > 0.3 bar.

E.g.: Inlet pressure 4.2 bar. Alarm on at 3.3 –2.4 bar. Alarm off at

max. 3.9 bar.

Alarm volume

≥ 80 dB at a distance of 30 cm

Setting range of the

oxygen concentration

21 –100%

Gas inlet pressure

3.2 –6.5 bar: air and oxygen pressure differential should be

within max. 0.7 bar

Accuracy of the mixed

gases (FIO2)*

± 3% oxygen

Connection types

DISS outlets for mixed gases and NIST inlets for air and

oxygen

Dimensions (LxWxH)

13 x 16.5 x 12.2 cm

Weight

1600 g

Operating temperature

+5°C to +50°C

* The accuracy of the oxygen concentration can be affected if the bleed is not activated in accordance

with the specifications.

This air-oxygen mixer has been degreased before it was delivered to prepare it for

use with oxygen. The reverse gas flow of the air-oxygen mixer corresponds to

clause 9 of the ISO 11195 standard. The oxygen-analysis device being used must

comply with the ISO 80601-2-55 standard and the CE regulations.

7. Pressure drop in the system

Low Flow

≤ 0.14 bar at inlet pressures from 3.2 to 6.5 bar,

with a flow rate of 10 l/min at 60% FIO2

High Flow

≤ 0.21 bar at inlet pressures from 3.2 to 6.5 bar,

with a flow rate of 30 l/min at 60% FIO2

8. Transportation and storage conditions

Temperature range

-20°C to 50°C

Humidity

Max. 95% non-condensing air humidity

9. Dryness and composition of the supply gases

Air:

The medical air supply must meet the requirements of the national standards.

Oxygen:

The oxygen being used must meet all requirements for medical oxygen according

to the European Pharmacopoeia.

10. Illustrations and identification of components

CAUTION

The labelling on the device will not come off if you follow the preparation

instructions properly. Contact the manufacturer or your local representative if

the labelling becomes unreadable.

These images show the Quality Mix Low Flow

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