GCE MediVital E Istruzioni per l'uso

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

NL

DRUKREGELAARS MET GEÏNTEGREERDE

CILINDERKLEPPEN

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EN

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 ﬁ tted 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 ﬂ ammable anaesthetics and

substances.

2.1. PATIENT PROFILE

Medivital®E supplies medical gas by means of the control ﬂ ow head in ﬂ ow 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 ﬁ eld 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

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EN

3. OPERATIONAL, TRANSPORT AND STORAGE SAFETY

REQUIREMENTS

KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:

• Heat sources (ﬁ re, 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 ﬁ rst 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-oﬀ 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.

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EN 5. PRODUCT DESCRIPTION

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

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

by the main shut-oﬀ valve then passed through the pressure regulator and ﬁ nally delivered to

the patient through the ﬂ ow outlet or the pressure outlet. The outlet pressure is ﬁ xed 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 ﬂ ow is

not controlled by the combination valve,

• combination valve with an outlet via calibrated nozzles, the outlet ﬂ ow 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 deﬁ ned 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

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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 ﬁ tted to a gas cylinder by a threaded inlet stem. The inlet stem can

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

material.

B  FILLING PORT

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

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

are required to vent gas from the cylinder during the ﬁ lling 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 ﬂ ow. The indicator is active, i.e. the amount of gas

in cylinder is indicated regardless to shut-oﬀ 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-oﬀ valve to isolate the gas in the cylinder from

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

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

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 ﬁ rm 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 ﬂ ow 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 ﬁ lling 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 ﬂ ow control head “F”.This function is used to

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

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

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

threaded connection).

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Movement of the ﬂ ow outlet ‘G’ is normal due to the method of ﬁ xing in the main body. It does

not indicate a faulty ﬂ ow outlet.

H  PRESSURE OUTLET OR QUICK COUPLER OPTION

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

gas direct from the low-pressure part of the combination valve and it is ﬁ tted with a gas speciﬁ c

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

piece of equipment to this outlet with a gas speciﬁ c 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 ﬂ ow 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 ﬂ ow 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, ﬂ ow 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 ﬂ ow

head is used.

At simultaneous use of ﬂ ow 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 ﬁ re.

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 ﬂ ow head outlet

is used).

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EN

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 ﬂ ow (ﬂ ow 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 ﬂ ow control head position. It is

intended to detect the actual set ﬂ ow 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 ﬂ ow control head.

A

B

A.

Remaining time until the cylinder pressure drops to 15

bar at an actual ﬂ ow. The indicated parameter is regularly

updated. The remaining time is automatically compensated

by the variation of ambient temperature.

B.

Bar chart equal to the pressure inside the gas cylinder.

Indications when null ﬂ ow is set or when the quick coupler is used

A

C.

Actual pressure in the gas cylinder.

A

B

C

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2D code

A.

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 ﬁ lling stations or maintenance

purposes.

B:

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

A

Signalization of an incorrect RPV function.

A.

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

modiﬁ ed 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 ﬁ eld in the mobile

application (see. 6.1.3).

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EN

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 conﬁ gure it using the mobile application, see chapter

6.1.3.

This functionality is intended primarily for ﬁ lling stations.

Activate the E-GAUGE by turning the ﬂ ow 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 inﬂ uenced by this feature, especially when there is a signiﬁ cant

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 ﬂ ow. This fact provides the patient with a su cient security reserve time.

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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 - ﬁ rst 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 ﬂ ashing

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 ﬂ ashing 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 signiﬁ cantly 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 ﬂ ow is too low, this status may not be

detected.

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

quick coupling may be temporarily indicated during the

subsequent cooling down process.

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Tempering of the device

• The warning is indicated if the E-GAUGE indicates a

rapid change in temperature caused by eg. moving the

device between two rooms with a high diﬀ erence in

temperatures.

• Only the pressure parameter is indicated.

• The warning T symbol is indicated (temperature).

5.1.2.2. Error alarms - related to the evaluation of the error status of the device. These are

marked with a big warning triangle in the left part of the display (except the "Low battery

voltage" warning)

Low battery charge

• A warning is indicated when there is a low battery charge

(2,7V and less).

• The battery symbol is permanently indicated

• The battery symbol is static, it does not have an active bar

chart indicator and always includes one bar.

• The use of the device may continue but at the earliest

cylinder ﬁ lling, the battery must be changed.

• The symbol may be indicated even when the battery

charge is OK, but the cylinder was moved to a room with

low ambient temperature. The symbol disappears when

the cylinder warms up again.

Error of the pressure measure

• A warning is indicated when there is a defect of pressure

sensor.

• The symbol ??? is indicated instead of the pressure or

remaining time.

• The PS (pressure sensor) is indicate.

• The bar chart is not indicated.

• Discontinue the cylinder from service immediately and

send it back to the owner of the ﬁ lling station. Service

must be performed by a GCE certiﬁ ed service centre.

If MediVital®E is not used for long periods, check the display of the E-GAUGE every 3 months.

If the symbol is shown on the display, the valve can still be used, but the valve must

be replaced at the latest within 3 months of detecting this situation. If this is not done, the

operation of the E-GAUGE may be unexpectedly terminated.

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EN

Error of the ﬂ ow measure

• A warning is indicated when there is a defect of the low

head sensor, its disconnecting or if the ﬂ ow control head

is outside the deﬁ ned position (e.g. in between two ﬂows).

• Only the pressure value is indicated.

• The warning symbol FS (ﬂ ow sensor) is indicated.

• Discontinue the cylinder from service immediately and

send it back to the owner of the ﬁ lling station. Service

must be performed by a GCE certiﬁ ed service centre.

No ﬂ ow

• A warning is indicated if the selected position of the

control ﬂ ow head is > 1 l/min but simultaneously no

decrease in the cylinder gas pressure is reported (e.g.

closed shut-oﬀ valve or throttled outlet hose)

• The evaluation time depends on the set ﬂ ow and the

cylinder volume, typically 2-10 minutes.

• Only the pressure parameter is indicated.

• The warning symbol FE (ﬂ ow error) is indicated.

• Check if the shut-oﬀ valve is open or if the hose is not

throttled. Perform necessary actions. If the indication

does not disappear within few minutes, discontinue the

cylinder from service.

• Evaluation of FE alert is blocked for ﬂ ows under 1 l/min.

• The FE symbol can be hidden by switching of the ﬂ ow

control head to diﬀ erent position.

An FE alert can be displayed incorrectly if the ﬂ ow head control is set to low ﬂ ow (1-2 l/min

typically) and the ambient temperature increase rapidly in the same time.

Device outside operational temperature

• A warning is indicated in case the valve is moved to a

room with temperature outside the allowed range of

operational temperature, see chapter 3.

• Only the pressure parameter is indicated.

• The warning symbol TC (thermal conditions) is indicated.

• If you want the Medivital®E to be operational, it must be

moved to a room which complies with the requirements

for allowed range of operation temperature (see chpt. 3).

5.1.3. BLUETOOTH

E-GAUGE is equipped with a Bluetooth module for wireless data communication in the licence-

free zone of 2,4 to 2,5 GHz. Bluetooth communication is mainly used for primary calibration of

the pressure sensor and the ﬂ ow head sensor and for setting up of the conﬁ guration of the gas

cylinder size and type of the control ﬂ ow head during assembly of the valve to the gas cylinder.

Operational frequency: 2,4 GHz ISM zone (zone for radio transmitting in industrial, academic

and medical ﬁ eld)

Eﬀ ective radiation power: max. 3 dBm.

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Maximal distance for safety connection between the device with an installed mobile

application GCE eGauge and the E-GAUGE is 10 meters in an open space. In closed spaces

this distance shortens.

6. USE OF PRODUCT

6.1. OPERATIONS PERFORMED BY THE USER

Contact a relevant ﬁ lling station, or manufacturer if you need help with the, maintenance or

unexpected operation of the Medivital®E.

6.1.1. BEFORE USE

Visual inspection before use:

• Check the combination valve for damage (incl. label and marking). If it shows signs of external

damages, remove the product from service and suitably identify its status.

• Check the combination valve for contamination. Apply the cleaning procedure according to

chapter 8 if needed.

• Check that the cylinder´s gas pressure indicator indicates suﬃ cient pressure.

Leak-tight and functional test before use:

• Set ﬂ ow control head (if any) to the ZERO position - ensure the ﬂ ow control head engages

correctly.

• Slowly open the shut-oﬀ valve hand wheel (anticlockwise) until fully open - after approx. 1 turn

(see indication in the picture in chapter 5).

• Check for leakage by listening (leakage would be heard as the characteristic hiss of ﬂ owing

gas).

• Check that there is a gas ﬂ ow at each ﬂ ow control head set position in both clockwise and

anticlockwise turning directions (for instance by sound or by checking for the presence of

bubbles in a humidiﬁ er).

• Close the shut-oﬀ valve (clockwise). Do not use excessive torque (max. closing torque is 5

Nm).

• Reset the ﬂ ow control head to ZERO position and ensure the ﬂ ow control head engages

correctly.

• For a combination valve ﬁ tted with a pressure outlet, ensure it is in working condition by

connecting and disconnecting the quick-coupler probe.

6.1.2. USE OF THE COMBINATION VALVE

6.1.2.1. Use of the combination valve´s ﬂ ow outlet and setting the ﬂ ow:

• Ensure the ﬂ ow control head is in position “0”.

• Connect the accessories to the ﬂ ow outlet.

• Slowly open the shut-oﬀ valve hand wheel (anticlockwise) until fully open - after approx. 1 turn

(see indication in the picture in chapter 5).

• Set the ﬂ ow head to the required ﬂ ow position. Ensure the ﬂ ow control head engages correctly.

• After the required ﬂ ow has been set, the E-GAUGE calculates the remaining gas supply time,

which is constantly updated and corrected according to the current ﬂ ow rate.

Before connecting any accessory to the ﬂ ow outlet make sure that the patient is not connected.

Sudden opening could result in the danger of ﬁ re or explosion arising from oxygen pressure

shocks. Insu ciently opening the shut-o valve could reduce the actual ﬂ ow delivered.

Always ensure that the ﬂ ow control head has been correctly set and not placed between two

settings. The ﬂ ow control head placed between settings will not deliver the correct ﬂ ow of

medical gas.

In case any visual or acoustic warnings are indicated, follow the instructions in the table - see

chapt. 5.1.2.

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Common variants of the ﬂ ow control head can have an “end stop” in between the maximum

ﬂ ow position and the zero position. Do not try to apply excessive force on the ﬂ ow control

head when it stops in the maximum ﬂ ow position (during clockwise rotation) or in the zero

position (anti-clockwise rotation).

The medical gas ﬂ ow rate must be prescribed by a doctor.

Check regularly that the E-GAUGE is in operation and indicates the expected parameters and

data.

6.1.2.2. Using the combination valve´s pressure outlet

• Ensure the ﬂ ow control head is in position “0” (if included).

• Slowly open the shut-oﬀ valve hand wheel (anticlockwise) until fully open - after approx. 1 turn

(see indication in the picture in chapter 5).

• Connect accessories to the pressure outlet if not already connected.

• In this mode, the E-GAUGE indicates only the immediate cylinder´s gas pressure parameters.

Before connecting any accessory to the pressure outlet make sure that the patient is not

connected and the accessory outlet is secured.

Regularly check that the E-GAUGE is in operation and indicates the expected parameters and

data.

In case any visual or acoustic warnings are indicated, follow the instructions in the table - see

chpt. 5.1.2.

If the pressure outlet is to be connected to a medical device that requires a high gas ﬂ ow (for

instance a pulmonary ventilator that requires a gas ﬂ ow of 100 l/min at the minimum pressure

2.8 bar), compare the required ﬂ ow of connecting the medical device with the pressure and

ﬂ ow characteristics of the combination valve stated in appendix No. 1. To assure su cient

performance (pressure and ﬂ ow characteristics of the combination valve ) the medical device

should not be used if the pressure indicator enters the red zone.

Sudden opening could result in the danger of ﬁ re or explosion arising from oxygen pressure

shocks. insu ciently opening the shut-o valve could reduce the actual ﬂ ow delivered.

If a pressure outlet as well as a ﬂ ow outlet are part of the combination valve do not use them

simultaneously, especially if the pressure in the cylinder is below 50 bar, as it could adversely

a ect the outlet parameters of the combination valve.

6.1.3. AFTER USE

• Close the shut-oﬀ valve (clockwise). Do not use excessive torque(max. closing torque is 5 Nm).

• Vent pressure from the connected devices.

• Disconnect all connected devices from user outlets.

• Set the ﬂ ow control head on "0" (if included).

7. ACCESSORIES

Accessories connectable to ﬂ ow outlet:

• hose connected with mask, cannula or humidiﬁ er.

Accessories connectable to pressure outlet:

• low pressure hose (working pressure >10 bar), ﬂ owmeters, Venturi suction ejectors, lung

ventilators.

Other user accessories:

• bed hanger, humidiﬁ er holder.

Accessories for ﬁ lling stations:

• ﬁ lling adaptor.

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Before connecting any accessory or medical device to the combination valve, always check

that they are fully compatible with connection features & performances of the product.

8. CLEANING

Remove dirt with a soft cloth damped in oil free soapy water & rinsed with clean water.

Disinfection can be carried out with an alcohol-based solution (with damp wipes).

If other cleaning solutions are used, check that they are not abrasive and they are compatible

with the product materials (including labels) and gas (convenient cleaning solution - i.e.

Meliseptol).

The distributor of the device must secure the cleaning, or disinfection of the device before

handing it over to the end user according to the above mentioned procedure.

If needed, the cleaning can be performed by the end user according to the above procedure.

Do not use cleaning solutions containing ammonia!

Do not expose to water or any other liquid.

Do not expose to high temperatures (such as autoclave).

To apply the cleaning solution do not spray it as the spray may enter the inner parts of the

combination valve and cause contamination or damage.

Do not use a pressure washer as it could damage or contaminate the combination valve .

If the inner parts of the combination valve have been contaminated do not continue to use the

combination valve under any circumstances. It must be discontinued from service.

9. SERVICE, PRODUCT LIFETIME AND MAINTENANCE

9.1. PRODUCT LIFETIME

Serial number and manufacture date

An eleven-ﬁ gure serial number (SN) stamped on combination valve body consists of the data

as follows:

YYYYMM XXXXX

YYYY: year of manufacture

MM: month of manufacture

XXXXX: sequence number of the product

For example: The serial number 201503 00521 indicates the combination valve manufactured

in 2015, in March, with sequence number 521.

Product lifetime and waste management

End of lifetime is marked on the combination valve body this way:

YYYY/MM

YYYY: year of lifetime end

MM: month of lifetime end

Maximum lifetime of this product is 15 years from the date of manufacturing.

At the end of the product’s lifetime, the product must be discontinued from service.

The provider of the device shall prevent the reuse of the product and handle the product in

compliance with “Directive of European Parliament and Council 2008/98/EC on Waste“.

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In accordance with Article 33 of REACH GCE, s.r.o. as a responsible manufacturer shall inform

all customers if materials containing 0.1% or more of substances included in the list of Substance

of Very High Concern (SVHC).

The most commonly used brass alloys used for bodies and other brass components contain

2-3% of lead (Pb), EC no. 231-468-6, CAS no. 7439-92-1. The lead will not be released to the gas

or surrounding environment during normal use. After the lifetime has expired, an authorized

metal recycler shall scrap the product to ensure eﬃ cient material handling with minimal impact

to environment and health.

To date we have no information that indicates that other materials containing SVHC of

concentrations exceeding 0.1% are included in any GCE product.

Battery lifetime

The typical battery lifetime is 3 years of which the device is constantly in operation. Decrease

in the battery voltage by the end of its lifetime is indicated by the icon on the display of the

device. See chpt. 5.1.2.2.

The operation of the device below -10 °C and above + 40 °C negatively aﬀ ects the battery

lifetime.

9.2. PREVENTIVE MAINTENANCE

Medivital®E does not require any special preventive maintenance, checks or calibration with

the exception of checking that the E-GAUGE functions properly.

9.3. REPAIR AND SERVICE OPERATIONS

A GCE certiﬁ ed person who also holds all the necessary certiﬁ cates in compliance with national

standards for mounting and repairing of dedicated gas devices can only carry out the necessary

repairs and service.

For information about an authorised service centre in your area please contact a GCE or

distributor of GCE product.

Usually the combination valves can be repaired while ﬁ tted on the cylinder.

Repairs that do not need to be done by a certiﬁ ed personnel include exchanging of the below

mentioned components:

• guard,

• labels,

• protective covers and separable hose adaptors.

The E-GAUGE must not be repaired when the device is in use by a patient.

All labels on the equipment must be kept in good, legible condition by the provider and the

user during the entire product lifetime.

Use only genuine GCE components.

Any product sent back to GCE (or a GCE authorised centre) for repair or maintenance shall be

properly packaged to prevent contamination or damage during storage, transportation and

handling.

For product to be repaired, the fault short description or some reference to a claim number

should be indicated.

9.4. END OF OPERATION

• Withdrawal from operation can be performed either by the owner or ﬁ lling station:

• Perform the inner venting of the valve - chapter 6.1.4.2.

• Vent the gas from the cylinder, incl. the residual pressure - chapter 6.1.4.4.

• Disassemble the valve from the cylinder - chapter 6.1.6.

• Prevent reuse of the valve and dispose it according to the relevant legislation - chapter 9.1.

• For speciﬁ cation of the proper means of disposal for potentially biological dangerous parts of

accessories must the general public must contact the relevant local council.

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9.5. ENVIRONMENT

There are not any know risks related to disposing the of Medivital®E device at the end of its

lifetime. The battery and electronics must be disposed of in a special recycling centre. Other

components may be disposed of in a standard way.

10. TECHNICAL DESCRIPTION

THE DEVICE MEDIVITAL®E COMPILES WITH THE FOLLOWING ELECTRICAL STANDARDS

Electric safety: EN60601-1:2006 as amended

Electromagnetic compatibility: EN60601-1-2:2015 as amended

Medical devices used in the home care conditions: EN60601-1-11:2015 as amended

Degrees of protection: EN 60529 2015 as amended, IP55

10.1. EMC CONDITIONS

The Medivital®E combination valve is adequate for use in homes, hospital and ambulance care,

etc. Avoid use near devices with high intensity of electromagnetic disturbance, such as magnetic

resonance, VF surgical tools, etc. The device does not included any wires or transmitters which

would lead to an increase of EM emissions or decrease EM resistance of the device.

Essential performance of the device may be worsened by the electromagnetic disturbance.

Medical electrical devices require special safety measures concerning electromagnetic

compatibility and it is necessary to install them and put them into operation according to the

information on electromagnetic compatibility stated in this document.

Portable and mobile radio frequency communication equipment may negatively a ect

medical devices.

Medivital®E may be interfered by other equipment, even though they meet the conditions for

radiation according to the CISPR requirements.

Medivital®E should not be used in vicinity to other equipment or placed on that equipment. If it

cannot be avoided, the valve with E-GAUGE should be tested in normal operation composed

in conﬁ guration as it will be used.

It should be avoided to use Medivital®E next to or in a block with other devices because

it could cause incorrect operation. If such use is necessary, Medivital®E and other devices

should be observed to prove that they function normally.

The E-GAUGE ensures indication only and is not intended for assurance of monitoring or

alarm functions in the context of permanently sustainable lifetime. The monitoring functions

may fail, without this failure being connected with an unacceptable risk, and therefore this

equipment does not state any technical parameters whose maintaining in a failure condition

is requested.

Transportable RF communication device (including end devices such as antenna cables

and external antenna) should not be used closer than 30 cm from any part of Medivital®E.

Otherwise it could lead to worsening the functionality of such device.

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11. GLOSSARY

Consult Instruction for use Suitable for Hospital care

use

Caution! Suitable for Emergency care

use

Keep away from heat and

ﬂ ammable materials. Suitable for Home care use

Keep away from oil and

grease! Fragile, handle with care

Keep dry! Weight of product

Humidity limit Atmospheric pressure

limitation

Temperature limit Use by date

Inlet parameter SN Serial number

Outlet parameter REF Catalogue number

P1Inlet pressure LOT Batch code

P2Outlet pressure REF 1 Reference number

IP 55

Level of security against

foreign parts and water

intrusion

Deliver the battery for

recycling

Manufacturer Do not reuse

Date of manufacture

Take the equipment back for

recycling. Do not dispose

equipment into unsorted

municipal waste.

MR Conditional Type BF applied part

12. WARRANTY

The Standard Warranty period is two years from date of receipt by the GCE Customer (or if this

is not known 2 years from time of the product manufacture shown on the product).

The standard warranty is only valid for products handled according to Instruction for use (IFU)

and general industry good practice and standards.

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APPENDICES:

No. 1 – Technical and performance data

No. 2 – Quick-coupler features and connecting/disconnecting procedure

No. 3 – Post Filling Checks

No. 4 – Valve assembly and ﬁ lling instruction

MANUFACTURER:

GCE, s.r.o. Tel: +420 569 661 111

Zizkova 381 Fax: +420 569 661 602

583 01 Chotebor http://www.gcegroup.com

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1. ÚVOD

Výrobek je ve shodě se základními požadavky směrnice o prostředcích zdravotnické techniky

93/42/EHS a směrnice o přepravitelných tlakových zařízeních 2010/35 EU.

Ventil je navržen dle norem EN ISO 10524-3 a EN ISO 10297.

TERMÍN VÝZNAM

MEDIVITAL®E Kombinovaný ventil MediVital®E vybavený elektronickým indikátorem

tlaku E-GAUGE

E GAUGE E-GAUGE

DISPLEJ Elektronické zobrazovací zařízení.

2. ÚČEL POUŽITÍ

Kombinované ventily MediVital®E jsou určeny pro montáž na tlakové lahve používané pro

medicinální plyny. Tyto kombinované ventily s tlakovou lahví tvoří sestavy, které slouží buď jako

zdroj plynu pro zdravotnická zařízení (anesteziologické přístroje, ventilační přístroje, inkubátory,

atd.) anebo k přímému dávkování plynu do inhalační masky nebo kanyly pacienta.

GCE kombinované ventily jsou určené k použití s následujícími medicinálními plyny:

• kyslík;

• oxid dusný (rajský plyn);

• medicinální vzduch;

• helium;

• oxid uhličitý;

• směsi výše uvedených plynů;

Kombinovaný ventil MediVital®E není určen pro použití s hořlavými anestetiky a látkami

2.1. PACIENTSKÝ PROFIL

Redukční ventil MediVital®E dodává medicinální plyn pomocí průtočné hlavy v rozsahu průtoku

0 do 15 (25) l/min.

Saturace medicinálního plynu musí být stanovena lékařem nebo anesteziologickou zdravotní

sestrou, kteří mají zdravotnické vzdělaní, posoudí zdravotní stav pacienta a podají mu potřebné

množství medicinální plynu.

Zdravotní status – použití v případě, že pacient bude potřebovat dodávku medicinálního plynu

pro podporu dýchání. Rozhodnutí o terapii provádí lékař nebo zdravotnický personál.

Zdravotnický personál – zdravotní sestra, záchranář, zdravotník nebo ošetřovatel, který má

zdravotnické vzdělání.

2.2. UŽIVATELSKÝ PROFIL

Použití v nemocnici nebo v sanitce:

• Vzdělání: personál se zdravotnickým vzděláním

Použití v domácí péči:

Terapie je předepsána lékařem nebo osobami, které mají zdravotnické vzdělání v oblasti pro

podporu dýchání:

• Znalost: proškolení osob se zdravotnickým vzděláním se schopností pročíst, proškolit a

aplikovat znalosti z návodu k použití.

Školení musí být provedeno podle zákonů platných v jednotlivých zemích.

Důležité:

Pacient musí být proškolen lékařem nebo osobou, která má vzdělání v oblasti záchrany života.

ČESKY

NÁVOD K POUŽITÍ: MEDIVITAL®E

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GCE MediVital E Istruzioni per l'uso

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