GCE MediVital E Manuale utente

INSTRUCTION FOR USE

NÁVOD K POUŽITÍ

BEDIENUNGSANLEITUNG

ISTRUZIONI PER L'USO

GEBRUIKSAANWIJZING

GCE VALVES

PRESSURE REGULATORS INTEGRATED

WITH CYLINDER VALVES EN

MediVital®E

REDUKČNÍ VENTILY S INTEGROVANÝM

UZAVÍRACÍM VENTILEM PLYNOVÝCH LAHVÍ CS

DRUCKREGLER MIT FLASCHENVENTILEN DE

REGOLATORI DI PRESSIONE

CON VALVOLA DELLA BOMBOLA INTEGRATA IT

DRUKREGELAARS MET GEÏNTEGREERDE

CILINDERKLEPPEN

2/132

1. FOREWORD

The product complies with the essential requirements of 93/42/EEC Medical Device Directive

and Transportable Pressure Equipment Directive 2010/35 EU. The combination valve is

designed according to EN ISO 10524-3 and EN ISO 10297 standards.

TERM MEANING

MEDIVITAL®E Combination valve MediVital®E is equipped with an electronic pressure

indicator E-GAUGE

EGAUGE Electronic indicator

DISPLAY Electronical indication device

2.INTENDED USE

MediVital®E Combination Valves are designed to be ﬁtted to gas cylinders used for medical

gases. These combination valves together with a gas cylinder form gas packages used either

as gas supply point for medical devices (anaesthetic devices, ventilating devices, incubators

etc.) or for direct gas supply to a patient’s breathing mask or cannula.

GCE Combination Valves are intended to be used with the following medical gases:

• Oxygen

• Nitrous oxide

• Air for breathing

• Helium

• Carbon dioxide

• Mixtures of the gases listed above.

MediVital®E combination valve is not intended for use with ﬂammable anaesthetics and

substances.

2.1. PATIENT PROFILE

Medivital®E supplies medical gas by means of the control ﬂow head in ﬂow range from 0 to 15

(25) l/min.

Saturation of the medical gas must be prescribed by the doctor or an anaesthetic nurse who

has got the medical education, assessed the heath status of the patient and supplies him with

required amount of the medical gas.

Health status - the assesment and decision about the use timing and dosage amount

requirements of the patient is up to the doctor or medical personnel.

Medical personnel - nurse, rescuer, paramedic or carer who has obtained medical education.

2.2. USER PROFILE

Use in the hospital or ambulance:

• Education: personnel with medical education

Home care use:

Therapy is prescribed by a doctor or personnel who has got a medical education in the ﬁeld of

breathing support:

• Knowledge: training of personnel with medical education who has got an ability to read, train

and apply knowledge from the instruction for use.

Training must be performed according to regulations valid in each country.

Important:

Patient must be trained by the doctor or person who has got an education in the life saving.

ENGLISH

INSTRUCTION FOR USE: MEDIVITAL®E

3/132

3.OPERATIONAL, TRANSPORT AND STORAGE SAFETY

REQUIREMENTS

KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:

• Heat sources (ﬁre, cigarettes,...)

• Flammable materials

• Oil or grease (take a great care in the use of hand creams)

• Water

• Dust

The product and its associated equipment must be prevented from tipping over, turning over

or falling.

Always maintain oxygen cleanliness standards.

Only use the product and its associated equipment in well ventilated area.

Before the ﬁrst use the product shall be kept in its original package. If removed from service

(for transport, storage) GCE recommends using the original package (including inner packing

materials). National laws, rules and regulations for medical gases, accident prevention and

environmental protection must be observed.

OPERATING CONDITIONS STORAGE AND TRANSPORT CONDITIONS

MIN MAX MIN MAX

-20 °C* +65 -40 °C +70 °C

10 % 100 % 10 % 100 %

600 mbar 1200 mbar 600 mbar 1200 mbar

*for inner tightness of the shut-o valve, during transport and storage of the combination valve

mounted on a cylinder, the valid lower temperature limit is -40°C.

If the valve is used in the reach of a patient, the ambient temperature must not exceed 40°C.

When used in home care, the acclimatization time after a change of conditions from storage

(or transport) to operational must be at least 1 hour.

In case of the combination valve storage temperature drops below -20°C do not use the

combination valve until its temperature reaches at least -20°C.

In case the ambient valve temperature drops below -10°C or rises above +40°C, the battery is

being self-discharged, and therefore the lifetime is shortened.

For the combination valves designed to be used with mixture of gases O2+N2O, the lowest

operating temperature is +5°C. In normal use of the combination valve, frosting can appear on

the combination valve surface, which is caused by the gas inside the combination valve when

high pressure in the combination valve cooling when high pressure gas is being reduced to

low pressure (Joule-Thomson eect).

O2+N2O mixtures are temperature sensitive. N2O begins to separate out from the mixture if

the temperature falls below about -6°C. A homogenous mixture is again obtained when the

temperature has raised above 10°C and the cylinder was agitated. Before use, to ensure it is

properly mixed, cylinders should be stored horizontally for 24 hours at a temperature above

10°C. If this is not practicable, before use the cylinders must be maintained at a temperature

above 10°C for at least 2 hours and then completely inverted three times or placed in warm

water at body temperature for 5 minutes and then completely inverted three times.

4/132

EN 5.PRODUCT DESCRIPTION

A combination valve combines the function of a shut-o valve of a high pressure gas cylinder

and a pressure regulator for use with medical gases. Gas from the cylinder is ﬁrst controlled

by the main shut-o valve then passed through the pressure regulator and ﬁnally delivered to

the patient through the ﬂow outlet or the pressure outlet. The outlet pressure is ﬁxed by the

manufacturer and each combination valve is provided with a low-pressure relief valve to protect

against failure of the pressure regulator.

There are three basic alternatives:

• combination valve with a quick-coupler outlet, the outlet pressure is constant, and the ﬂow is

not controlled by the combination valve,

• combination valve with an outlet via calibrated nozzles, the outlet ﬂow is controlled by the

combination valve and can be changed by the control head,

• the combination valve with both alternatives.

SHUT OFF VALVE STATUS INDICATOR:

4.PERSONNEL INSTRUCTIONS

The Medical Devices Directive 93/42/EEC states that the product provider must ensure that all

personnel using the product are provided with the 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.

fully OPEN

green

fully CLOSED

red

partly OPEN

red / green

5/132

Marking detail

Inlet connection

type

Total weight

allowance of the

package

Filling port type

End of lifetime

Reference

number

Inlet pressure

Serial number

Compliance with

93/42 EEC

Compliance with

2010/35 EU

A  INLET STEM

The combination valve is ﬁtted to a gas cylinder by a threaded inlet stem. The inlet stem can

be taper threaded or parallel threaded with dierent sizes depending on the cylinder size and

material.

B  FILLING PORT

A ﬁlling port is provided for ﬁlling the gas cylinder at a ﬁlling station, it has no function for

patient use. It includes a non-return valve (NRV). The NRV means that special ﬁlling adaptors

are required to vent gas from the cylinder during the ﬁlling process (venting and/or vacuuming

cylinders).

C  ELECTRONIC INDICATOR EGAUGE

The E-GAUGE is intended for indicating the amount of gas inside the gas cylinder and the

remaining time of gas supply at the current ﬂow. The indicator is active, i.e. the amount of gas

in cylinder is indicated regardless to shut-o valve position. More information can be found in

Chapter 5.1 - ELECTRONIC INDICATOR E-GAUGE.

D  SHUTOFF VALVE

The combination valve is provided with a shut-o valve to isolate the gas in the cylinder from

the rest of combination valve functions. It must be opened when ﬁlling the cylinder and patient

therapy. Part of the hand wheel is an indicator showing the open/close status of the shut-o

valve.

The shut-o valve´s open/close status indicator is for guidance only. The shut-o valve may

not be fully o when OFF status is showing. Fully closed status has to be checked by ensuring

the shut-o valve is turned fully clockwise until a ﬁrm resistance to the rotation is reached and

gas supply to the outlets has stopped.

The shut-o valve must not be used in the "partly ON" status because even though gas is

supplied to the outlets, the ﬂow can be limited due to an insuciently opened shut-o valve.

E  RESIDUAL PRESSURE VALVE

The combination valve is equipped with a residual pressure valve with a function to retain a

minimum positive pressure in the gas cylinder to avoid contamination of the cylinder content

by atmospheric air. During cylinder gas ventilation through the ﬁlling port the residual pressure

valve is bypassed.

F, G  FLOW CONTROL HEAD “F” AND FLOW OUTLET “G” OPTION

The combination valve can be delivered with a ﬂow control head “F”.This function is used to

supply adjustable gas ﬂow rates (l/min) at atmospheric pressure directly to a patient through the

ﬂow outlet “G”, for instance through a cannula or a facemask. The ﬂow outlet “G“ is equipped

with a hose ﬁtting (hose nipple) or a threaded type (for accessories to be connected using a

threaded connection).

6/132

Movement of the ﬂow outlet ‘G’ is normal due to the method of ﬁxing in the main body. It does

not indicate a faulty ﬂow outlet.

H  PRESSURE OUTLET OR QUICK COUPLER OPTION

The combination valve may be ﬁtted with a pressure outlet. The pressure outlet is supplied with

gas direct from the low-pressure part of the combination valve and it is ﬁtted with a gas speciﬁc

medical quick coupling connector also called a “quick coupler”. The user can connect another

piece of equipment to this outlet with a gas speciﬁc male probe (see appendix No. 2). The quick

coupler self seals when the male probe is disconnected. This outlet is for supplying gas at a

controlled pressure to power medical devices, for instance a medical ventilator.

I  PRESSURE RELIEVE VALVE OF THE LOW PRESSURE PART

The pressure relieve valve secures the low pressure part of the combination valve and

connected medical devices against over-pressure. If the gas pressure is decreased enough

after the pressure relieve valve activation, it will closes itself.

J  EXCESS FLOW DEVICE OR DIP TUBE OPTION

Excess ﬂow device ensures the safe ventilation of gas from the gas cylinder in case the

combination valve is broken above the inlet stem (e.g. cylinder fall). A dip tube does not have

such a function. The excess ﬂow device and dip tube are to avoid contamination from the

cylinder entering the combination valve .

PRESSURE RELIEF DEVICE OF THE HIGH PRESSURE PART  BURSTING DISC OPTIONAL

The high pressure relief device is intended to protect the cylinder and high pressure part of

the combination valve against damage caused by increased cylinder pressure. If the pressure

relief device has been activated, it will not reseal and the combination valve must be taken out

of service for repair (see Chapter 9).

Note: The colour of the product (especially the guard, ﬂow control head and shut-o valve)

does not have to match the gas colour coding.

5.1. ELECTRONIC INDICATOR EGAUGE

5.1.1. DEVICE DESCRIPTION

5.1.1.1. General warnings and important safety information

The actual parameter of the gas pressure inside the cylinder is shown even if the valve is not

used or the quick coupler is used as an outlet.

Indication of the remaining time of gas supply is only active when the outlet from the ﬂow

head is used.

At simultaneous use of ﬂow head outlet and pressure outlet (quick coupler) the indicated

parameters of the remaining time of gas supply are not accurate. The manufacturer does not

recommend using both outlets simultaneously during operational mode by the manufacturer.

(see chapter 6.2.2.2.)

No parts of the E-GAUGE can be replaced / repaired by the user. In case of a defect, the

product must be sent back to the manufacturer.

The battery is only replaceable by trained service personnel. An attempt to exchange the

battery without an authorized service technician may lead to dangerous situations such as

excessive heat or ﬁre.

Contraindication: No known contraindication exist. The E-GAUGE is only used to monitor the

gas pressure inside the cylinder and the remaining time of gas supply (only if ﬂow head outlet

is used).

7/132

5.1.1.2. General description

The E-GAUGE is used to show information about the pressure inside the gas cylinder and about

the remaining time of the gas supply - until the complete exhaustion of gas cylinder - at the

actually set ﬂow (ﬂow head outlet use only).

A  ELECTRONICS

The electronics of the E-GAUGE is located in the

plastic guard. The LCD display is used to indicate

of the operational information.

B  SENSOR OF THE FLOW CONTROL HEAD

POSITION

Inside the control unit there is an integrated

sensor of the ﬂow control head position. It is

intended to detect the actual set ﬂow to calculate

the time of the gas supply.

C – PRESSURE SENSOR

The pressure sensor installed in the valve port

provides a signal about the actual cylinder

pressure.

5.1.1.3. Storage and operational conditions

Storage and operational conditions are in compliance with the conditions for the complete

MediVital®E combination valve mentioned in the chapter 3.

5.1.1.4. Display description

Indications during operation of the ﬂow control head.

Remaining time until the cylinder pressure drops to 15

bar at an actual ﬂow. The indicated parameter is regularly

updated. The remaining time is automatically compensated

by the variation of ambient temperature.

Bar chart equal to the pressure inside the gas cylinder.

Indications when null ﬂow is set or when the quick coupler is used

Actual pressure in the gas cylinder.

8/132

2D code

The 2D code is intended for connecting the E-GAUGE

with a mobile application more easily.. Using Bluetooth

communication. The 2D code keeps information about

MAC address of E-GAUGE for ﬁlling stations or maintenance

purposes.

Indication of "cylinder volume" parameter related to the

E-GAUGE setup. If the symbol ??L is displayed, it is

necessary to perform parameterization using the mobile

application. See par. 6.1.3

Conditions applying to the 2D code appearance: Measured

pressure < 2,5 bar (respectively 7 bar in the case of a new

valve)

Exit from the 2D code mode: As soon as the pressure

grows, the E-GAUGE switches to the standard display

(pressure measuring, remaining time calculating)

Empty display

If the ambient temperature drops below -35°C, the display

operation is terminated automatically. This function

protects against any incorrect indication of characters due

to the low temperature. The display is switched on again

when the temperature rises above -30°C. This function is

not related to the condition of the battery.

Residual pressure indication

Signalization of an incorrect RPV function.

Symbol „R“ appears with a 30 min delay after the pressure

in cylinder drops below 2 bar.

Symbol „R“ disappears if actual pressure in the cylinder is

above 10 bar.

Security code

If the parameters "cylinder volume" and "pressure unit" are

modiﬁed using the mobile application, the new values can

be saved by inserting the 4-digit security code generated

by the E-GAUGE display into the input ﬁeld in the mobile

application (see. 6.1.3).

9/132

Deep sleep mode – low consumption of electrical energy

If the Medivital®E has not been in use for an extended

period (10 - 20 hours typically) and actual pressure in

cylinder is more than 15 bar at the same time.

If the Medivital®E has not been in use for an extended

period (10 - 20 hours typically) and actual pressure in

cylinder is less than 15 bar at the same time.

If zero pressure is indicated, the pre-set volume of the

cylinder is also displayed.

If the symbol ??L is visible (instead of a numeric value).

The parameter cylinder volume is not set and it is necessary

to conﬁgure it using the mobile application, see chapter

6.1.3.

This functionality is intended primarily for ﬁlling stations.

Activate the E-GAUGE by turning the ﬂow head knob into any position for normal operation.

The indicated gas pressure in the cylinder depends on the ambient temperature. The function

of the E-GAUGE can be inﬂuenced by this feature, especially when there is a signiﬁcant

variation in the ambient temperature.

The remaining time shown on the display is 5-10% shorter (in relation to the temperature,

cylinder size) than the real time in which the actual cylinder content would be emptied at a

constant ﬂow. This fact provides the patient with a sucient security reserve time.

10/132

5.1.2. VISUAL AND ACOUSTIC WARNINGS

Warning alarms are divided into two groups:

5.1.2.1. Operational alarms - related to the general use of the device. These are marked with a

warning triangle in the top part of the display.

Low pressure - ﬁrst warning

• In case the cylinder pressure drops under 50 bar.

• The display background becomes black.

• The warning symbol is indicated

• The acoustic signal starts simultaneously with the ﬂashing

red LED diodes located on the left of the display.

Low pressure - second warning

• In case the cylinder pressure drops under 15 bar.

• Information about the remaining time is exchanged by the

actual cylinder gas pressure value.

• The acoustic warning signal starts simultaneously with

the ﬂashing the red LED diodes located on the left of the

display.

If the "Low pressure" alarm is shown, the remaining gas in the cylinder can be consumed

very quickly. Pay close attention to the cylinder, prepare a reserve gas supply, and possibly

discontinue the cylinder from service immediately.

Indication of the simultaneous use of a quick coupler and hose connection

• When the E-GAUGE detects signiﬁcantly higher

consumption (about 4 l/min higher) than corresponding to

the ﬂow outlet consumption only.

• Only the pressure parameter is displayed

• The warning symbol of QC (quick coupler) is indicated

• If the QC outlet ﬂow is too low, this status may not be

detected.

• After the cylinder had been re-ﬁlled, the use of QC

quick coupling may be temporarily indicated during the

subsequent cooling down process.

Altri manuali per MediVital E

Indice

Lingue:

Altri manuali GCE Controllori

GCE

GCE DINCONTROL Manuale utente

GCE

GCE MEDISELECT II Manuale utente

GCE

GCE MediVitop Manuale utente

GCE

GCE MEDIEVAC+ Manuale utente

GCE

GCE mediline MEDIREG II Manuale utente

GCE

GCE UNISET Manuale utente

GCE

GCE S 400 Manuale utente

GCE

GCE Druva MTLX Manuale utente

GCE

GCE ECOSAVER+ Manuale utente

Manuali Controllori popolari di altre marche

Digiplex

Digiplex DGP-848 Istruzioni operative

YASKAWA

YASKAWA SGM series Manuale utente

Sinope

Sinope Calypso RM3500ZB Manuale utente

Isimet

Isimet DLA Series Style 2 Manuale di installazione

LSIS

LSIS sv-ip5a Manuale utente

Rockwell Automation

Rockwell Automation 1769-L31 Manuale utente

Airflow

Airflow Uno hab Manuale utente

ABB

ABB ACS580-01 drives Manuale utente

Panasonic

Panasonic GM1 Series Manuale utente

Emerson

Emerson SW93 Manuale utente

AutoAqua

AutoAqua Smart ATO micro SATO-120P Manuale utente

Panasonic

Panasonic FP? Positioning Unit RTEX Manuale utente

Samson

Samson Type 5824 Manuale di servizio

Alpha IP

Alpha IP MIOB 21001 Manuale utente

Siemens

Siemens OpenAir GMA 1 Series Manuale utente

Surecom

Surecom SR-629 Manuale utente

Fishman

Fishman TriplePlay Manuale utente

Regulus

Regulus SRS1 T Manuale utente