GCE MediFlowTec MEDIFLOW 2 User manual

GCE HEALTHCARE
MediFlowTec™, MEDIFLOW® II,
MEDIFLOW +
EN
FLOWMETERING DEVICES
FLOW SELECTOR; INSTRUCTION FOR USE
DISPOSITIVOS PARA MEDIR EL CAUDAL
CAUDALÍMETRO; INSTRUCCIONES DE USO
FLUSSOMETRI
MISWURATORE DI FLUSSO; ISTRUZIONI D´USO
FLUXÓMETROS; INSTRUÇÕES DE UTILIZAÇÃO
DEBITMETRES; NOTICE D´INSTRUCTIONS
FLOWMETER; BEDIENUNGSANLEITUNG
PRŮTOKOMĚRY; NÁVOD K POUŽITÍ
ES
IT
PT
FR
DE
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1. FOREWORD
GCE Flow selectors are medical devices classified as class IIa according to
the Medical Device Directive 93/42/EEC.
The Compliance with essential requirements of 93/42/EEC Medical Device
Directive is based upon 15002 standard.
2. INTENDED USE
Mediflow are devices intended for the administration of the following med-
ical gases in the treatment and care of patients:
• oxygen O2
• medical air AIR
• nitrous oxide N2O
The product is not intended to be use with air or nitrogen for driving
surgical tool.
This flow selector is intended to be fitted to medical gas pipeline system
terminal units in hospital or ambulance car or to quick connector outlet of
medical regulator, with nominal pressures up to 5 bar.
Using variants with maximum flow 50 l/min is necessary to be more care-
ful and outlet of the flow selector MUST NOT be connected directly to the
patient, for example via cannula.
The set value on the flow selector does NOT indicate real the actual flow
of medical gas – the dierence can be caused by dierent (missing) inlet
pressure or any fault on outlet hose (blocked, fold…)
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep away the product and its associated equipment from:
• heat sources (fire, cigarettes, …),
• flammable materials,
• oil or grease
• water
• dust
The product and its associated equipment must be prevented from
falling over.
ENGLISH
INSTRUCTION FOR USE:
MediFlowTec™, MEDIFLOW® II, MEDIFLOW +

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Use only the product and its associated equipment in well vented area.
Always maintain oxygen cleanliness standards.
Before initial use the product should be kept in its original packaging. GCE
recommends use of the original packaging (including internal sealing bag
and caps) if the product is withdraw from operation (for transport, storage).
Statutory laws, rules and regulations for medical gases, accident preven-
tion and environmental protection must be observed.
OPERATING CONDITIONS STORAGE AND
TRANSPORT CONDITIONS
-20/+60 °C -30/+60 °C
10/100% 10/100%
600/1200 mbar 600/1200 mbar
In case of storage at a temperature below -20 °C, do not operate the
flow selector until it has been allowed to increase its temperature to a
minimum of -20 °C.
4. PERSONNEL INSTRUCTIONS
The Medical Devices Directive 93/42/EEC states that product provider
must ensure that all personnel handling the product are provided with the
operating instructions & performance data.
Do not use the product without properly familiarization of the product
and its safe operation as defined in this Instruction for use. Ensure user
is aware of particular information and knowledge required for the gas
in use.

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5. PRODUCT DESCRIPTION
Gas from the medical gas pipeline system is entering through the inlet
connector (A). There are two basic versions: 1 – inlet connector is directly
mounted on the flow selector, 2 – connection to the rail, including hose
and inlet connector. Flow is then adjusted to the requested value by turn-
ing handwheel (B). The adjusted flow is visible in the window of the hand-
wheel /on the pointer (C). Gas is delivered to the user through the flow
outlet user connection (D).
B
C
A
DD
A
B
C
A. INLET QUICK CONNECTOR
The flow selector is fitted to the medical gas pipeline system terminal unit
or to medical regulator by a gas specific male probe.
B. HANDWHEEL
Requested gas flow can be adjusted by turning the handwheel to set the
required value in the viewing window / pointer (calibrated in l/min). By the
handwheel is possible to close the gas flow – adjusting value “0”.
C. READING WINDOW
Adjusted value of the gas flow is visible in reading window / on the top
side of the pointer.
D. USER OUTLET
The “flow outlet” user connection is usually with connection for hose (hose
nipple) or threaded (for humidifier).
This outlet is for supplying a gas flow (l/min) atmospheric pressure directly
to a patient, e.g. through a cannula or a facemask.
A
D
C
B