GCE E-MINISTAR Operating instructions

INSTRUCTION FOR USE

INSTRUCCIONES DE USO

NÁVOD K POUŽITÍ

NOTICE D’UTILISATION

GCE VALVES

PRESSURE REGULATORS INTEGRATED

WITH CYLINDER VALVE EN

E-MINISTAR

REGULADORES DE PRESIÓN INTEGRADOS

CON VÁLVULAS DE BOTELLA

REDUKČNÍ VENTILY S INTEGROVANÝM

UZAVÍRACÍM VENTILEM PLYNOVÝCH LAHVÍ

ROBINET A DETENTE INTEGREE AVEC VANNE D‘ARRET FR

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1. FOREWORD

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

2010/35 EU Transportable Pressure Equipment Directive and CDG TPE (Amendment) & (EU

Exit) Regulations 2020.

The valve is designed according to EN ISO 10524-3 standard.

TERM MEANING

EMINISTAR Pressure regulators integrated with cylinder valve equipped with

the EMM O2-X.Y.ZZZ and guard.

EMM O2

X.Y.ZZZ

Electronic Medical Module for Oxygen connected to the E-Ministar

sensor providing a function of gas content indicator.

Further only called Manómetro Digital Display.

Numbering X.Y.ZZZ deﬁ nes the hardware and software version and inlet

pressure for which the Manómetro Digital Display shall be used.

LCD Liquid crystal display

2. INTENDED USE

E-Ministar Combination Valves equipped with Manómetro Digital Display and guard 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

• Xenon

• Speciﬁ ed mixtures of the gases listed

2.1. PATIENT PROFILE

Regulator valve get gas ﬂ ow from 0 to 15 liter per minutes. Information about speciﬁ cation ﬂ ow

rate you can ﬁ nd in the appendix No. 1 of Instruction for use. Flow rate is listed in the Appendix

No. 1 of instruction of use in the table on the position C and this Appendix is supplied to every

product. The saturation of gas must be estimated by doctor or anesteziologic nurse. They have

necessary education, where they must know health status of patient and get him important gas

support. Health status - used, when the patient will be need to support of medical gases for

supporting breathing and decision about treatment is on the side doctor or health personal.

Health personal – nurse, rescuer, paramedic, keeper or person with medical education.

2.2. USER PROFILE

Use in a hospital or in an ambulance

• Education: personal with medical education

• Knowledge: training from person with medical education ability to read, study and knowledge

of user manual

• Training is provided according to local law in individuals countries.

ENGLISH

INSTRUCTION FOR USE: EMINISTAR

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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 (this includes hand creams)

• Water

• Dust

The product and its associated equipment must not be dropped and be prevented from falling

over wherever possible.

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

-20* / +65** °C -40 / +70 °C

10 / 100 % 10 / 100 %

600 / 1200 mbar 600 / 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.

**maximal touch temperature of the cylinder is +45°C.

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

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

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). Check that all patient associated equipment connected

to the combination valve is via a hose of at least 2 metres length.

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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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 for use & performance data.

Do not use the product without properly familiarization of the product and its safe opera-

tion as deﬁ ned in this Instruction for use.Ensure user is aware of particular information and

knowledge required for the gas in use.

5. PRODUCT DESCRIPTION

Combination valve combines the function of shut-oﬀ valve of a high pressure gas cylinder and

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

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

the patient through the ﬂ ow outlet or the pressure outlet. Outlet positive pressure is ﬁ xed by the

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

against undesirable exceeding of outlet pressure.

There are two basic alternatives:

• Valve outlet via calibrated nozzles, outlet ﬂ ows can be changed by the control knob

• Valve outlet via quick-coupler (the outlet ﬂ ow is a constant one) in combination with valve

outlet via calibrated nozzles where outlet ﬂ ows can be changed by the control knob

A  INLET STEM

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

be taper threaded or parallel threaded with diﬀ erent size 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

of cylinders).

Typical E-Ministar conﬁ guration (without guard and Manómetro Digital Display)

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C  MANÓMETRO DIGITAL DISPLAY

EMM O2X.Y.ZZZ

The Manómetro Digital Display provides an

indication of the amount of gas remaining

in the cylinder and the remaining amount

of time before the cylinder be comes

empty (based on the current ﬂ ow rate).

‘X.Y’ is a coding identifying the hardware

version (X) and software version (Y). ‘ZZZ‘

is a coding of inlet pressure for which the

Manómetro Digital Display shall be used.

For more information see Chapter 6 -

Manómetro Digital Display.

D  COMBINATION CONTROL KNOB

“SHUTOFF VALVE & FLOW SELECTOR“

The valve is ﬁ tted with combination control

knob for valve turning-on/oﬀ and setting of

particular ﬂ ows. The valve is turned on by

anticlockwise rotation from OFF position

to ON position. Particular ﬂ ows are set by

further anticlockwise rotation. The shut-oﬀ

valve is turned oﬀ by clockwise rotation to

OFF position.

E  RESIDUAL PRESSURE VALVE

Combination valve is equipped with a residual pressure valve with 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 by passed.

F, G  FLOW CONTROL HEAD “F” AND FLOW OUTLET “G” OPTION

Combination valve is 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

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

connection).

Movement of the ﬂ ow outlet ‘G’ is normal due to the method of ﬁ xing in the main body. It doesn’t

indicate a faulty ﬂ ow outlet.

H  PRESSURE OUTLET  QUICK COUPLER OR PURGE VALVE OPTION

The pressure outlet is the outlet direct from the low-pressure part of the valve and it is ﬁ tted with

a speciﬁ c quick connector or purge valve.

In the use of the valve with quick connector also called ”quick coupler“ (see appendix Nr 2) the

user can connect another piece of equipment to quick coupler with a gas speciﬁ c male probe

– quick-coupler probe. Its disconnection means self-sealing of the quick connector. This outlet

is for supplying gas at a controlled pressure to power medical devices, for instance medical

ventilator.

The valve without the quick coupler is provided with purge valve that is used to vent residual

pressure in the low-pressure part of the valve.

I  BURSTING DISC

The bursting disc is placed above the residual pressure vale E. It is a safety device which

prevents over-pressurization of the low pressure area of the valve.

Typical E-Ministar conﬁ guration

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J  PRESSURE RELIEVE VALVE OF LOW PRESSURE PART

Pressure relieve valve secures the low pressure part of 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.

K  EXCESS FLOW DEVICE OR DIP TUBE OPTION

Excess ﬂ ow device ensures safe ventilation of gas from gas cylinder in case the combination

valve is broken above inlet stem (e.g. cylinder fall). Dip tube does not have such function. Excess

ﬂ ow device and dip tube are to avoid contamination from cylinder entering the combination

valve. Dip tube also serves for ﬁ xing the sensor.

L  GUARD

The guard is an integral part of the E-Ministar. The guard consists of two halves assembled

together to the gas cylinder. In one half of the guard is secured Manómetro Digital Display.

Note: Colour of the product (especially guard and combination control knob) does not have

to match the gas colour coding.

6. MANÓMETRO DIGITAL DISPLAY EMM O2X.Y.ZZZ

6.1. MANÓMETRO DIGITAL DISPLAY DESCRIPTION

6.2.GENERAL WARNINGS AND IMPORTANT SAFETY INFORMATION

There are no user serviceable parts within the Manómetro Digital Display. In the case of a

fault, return to the gas package owner.

In the case of battery expiration, do not attempt to replace batteries, please return to the gas

package owner.

The equipment should not be serviced whilst in use with the patient

Contraindications: There are no contraindications to the use of the Manómetro Digital be-

cause it is only used for monitoring purposes.

6.3. GENERAL DESCRIPTION OF THE DIGITAL DISPLAY

The digital display provides the user with a clear view of the following information:

• Gas content of cylinder in litres (ltr). This is only displayed when valve is closed and there is

no gas ﬂ ow, or when remaining time calculation is running.

• Remaining time available for treatment at the current oxygen ﬂ ow rate. This is only displayed

when the valve is open and gas is ﬂ owing.

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6.4. DIGITAL DISPLAY OVERVIEW

A. Gas content indicator (H)

The segmented bar indicates how full the cylinder is according to the scale.

The content scale is divided into 13 segments as follows:

• Between 0 (Empty) and ¼ the scale is divided into four segments – Red area

• Between ¼ and ½ the scale is divided into three segments – Yellow area

• Between ½ and 1 (Full), the scale is divided into six segments – Green area

B. Cylinder content and time remaining indication (N1 and N2)

This gives the remaining time available for treatment at the current ﬂ ow rate.

This is only displayed when the valve is open and gas is ﬂ owing:

• When the ﬂ ow rate is altered, the actual gas ﬂ ow will change immediately, but the treatment

time remaining will need to be recalculated. During the remaining-time calculation the cylinder

content in litres (LTR) ‘N1’ is visible and the ‘L/MIN’ icon, label ‘I’ on digital display, blinks to

indicate that the remaining time calculation is in progress

• If the display shows “--:--” (without the Alert icon ‘L’ being displayed) then it indicates a system

fault. Please contact the gas package owner.

C. Cylinder gas content in litres (N1)

If cylinder is not in use or the remaining treatment time calculation

is not underway the cylinder content is indicated in standard gas litres.

When a cylinder is in storage or there is no cylinder movement, the digital display will move

into sleep mode. The system will automatically re-awaken if a ﬂ ow is detected or the cylinder

is gently moved.

D. Remaining treatment time at set ﬂ ow rate (N2)

If cylinder is in use and the remaining-time calculation is complete,

the remaining treatment time will be indicated in “hours : minutes”.

E. Bluetooth Active (manufacturer use only) (J)

When displayed, this icon indicates that the Bluetooth connection is active.

This is for use by the manufacturer during service operation.

K. Warning indicator

J. Bluetooth active

I. Flow rate (L/MIN)

L. Alerts

M. Battery icon

N1. If LTR visible,

number displayed

below is contents

in standard litres

N2. If HR:MIN

visible, number

displayed below

is remaining treat-

ment time,

at set ﬂ ow rate

H. Gas content indicator

Gas contents

indicator scale

/

/

KL M

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L. Alerts

F. Warning Indicator (K)

If this icon is displayed it indicates that a leak has been detected whilst

in storage mode. It indicates a loss of content in the cylinder by 10%

or more over a 24 hour period. Please contact the gas package owner if this appears.

G. Battery icon

The display unit’s battery life is designed to last 10 years, based upon standard use.

The battery icon will not be shown on the display unless there is 4 months, or less, of battery

life remaining.

If the battery icon is showing and all three internal segments are visible. The battery has an

estimated remaining life of between 3 and 4 months.

If the battery icon is showing and two internal segments are visible. The battery has an estimated

remaining life of between 2 and 3 months.

If the battery icon is showing and only one internal segments is visible. The battery has an

estimated remaining life of between 1 and 2 months.

If the battery icon is showing and there are no internal segments visible - only the battery

outline can be seen. The battery has a estimated remaining life of 1 month or less.

6.4.1. ALERTS

The Manómetro Digital will display and sound Alerts for inventory management purposes, when

the estimated amount of gas remaining in the cylinder, based on the current ﬂ ow rate, is less

than certain thresholds:

20 MINUTES The Alert icon is shown

with one segment:

Three short low frequency beeps sound.

15 MINUTES The Alert icon is shown

with two segments:

Three longer medium frequency beeps

sound.

10 MINUTES The Alert icon is shown

with three segments:

Three longer high frequency beeps sound.

5 MINUTES The Alert icon is shown

with three segments:

One longer high frequency beep sounds.

0 MINUTES The Alert icon is shown

with three segments:

AND the time remaining display shows

“00:00”.

One long beep sounds, descending in

frequency.

When 0 Minutes is indicated the cylinder is considered empty, but there may still be some

residual gas in the cylinder and therefore still some gas ﬂ ow.

6.5. BLUETOOTH WIRELESS TECHNOLOGY

The Manómetro Digital contains Bluetooth wireless technology which may be used to

communicate and transfer information, operating in the unlicensed industrial, scientiﬁ c and

medical band at 2.4 to 2.485 GHz. This is currently reserved for use by the manufacturer during

service operations.

• Contains Transmitter Module FCC ID: QOQBLE113

• Contains Transmitter Module IC: 5123A-BGTBLE113

Operating Frequency Range: 2402 – 2480 MHz

Channel Bandwidth: 2 MHz

Eﬀ ective Radiated Power: -1.15 dBm

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7. USE OF PRODUCT

7.1. OPERATIONS PERFORMED BY USER

7.1.1. 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.

• Visually check the combination valve for contamination. If needed, apply the cleaning

procedure according to chapter 9.

• Check if pressure is indicated on the content indicator of Manómetro Digital Display. If content

indicator of Manómetro Digital Display enters red zone, return the medical package (cylinder

with valve) for its reﬁ lling.

Leak-tight and functional test before use:

• Open slowly the combination shut-oﬀ valve by turning slowly the combination control knob

“shut-oﬀ valve & ﬂ ow selector“ in anticlockwise direction to ON position.

• By listening check for a leakage (the leakage would be heard as characteristic hiss of ﬂ owing

gas).

• Check that there is a gas ﬂ ow at each “ﬂ ow selector“ set position in both anticlockwise and

clockwise turning direction (for instance by sound or checking presence of bubbles in a

humidiﬁ er)..

• Turn oﬀ at the shut-oﬀ valve by turning the combination control knob “shut-oﬀ valve & ﬂ ow

selector“ in a clockwise direction to OFF position. Do not use excessive force (Maximum

recommended closing torque is 3 Nm).

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

connecting and disconnecting quick-coupler probe.

If any leakage is detected, apply the procedure described in Chapter 7.1.3. and return the

valve for service.

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

shocks.

7.1.2. USE OF COMBINATION VALVE

7.1.2.1. Use of combination valve ﬂ ow outlet and setting of ﬂ ow

• Ensure that the accessory is connected to the ﬂ ow outlet.

• Open slowly the combination control knob “shut-oﬀ valve & ﬂ ow selector“ in anticlockwise

direction to ON position.

• Set the combination control knob "shut-oﬀ valve & ﬂ ow selector" on one required ﬂ ow rate.

Before connecting any accessory to the ﬂ ow outlet make sure that the patient is not con-

nected.

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

shocks.

Always ensure that the combination control knob "shut-o valve & ﬂ ow selector" has been

engaged and not placed between two settings otherwise the ﬂ ow control head will not deliver

correct ﬂ ow of medical gas.

On ﬂ ow control head, each valve is provided with so-called "end stop" located downstream

the maximum ﬂ ow position. Do not try to apply excessive force on the combination control

knob "shut-o valve & ﬂ ow selector" when it stops on the maximum ﬂ ow position during an-

ticlockwise rotation.

Medical gas ﬂ ow rate must be prescribed by a doctor.

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7.1.2.2. Use of combination valve pressure outlet

• Ensure that the accessory IS NOT connected to the pressure outlet.

• Open slowly the combination shut-oﬀ valve by turning slowly the combination control knob

“shut-oﬀ valve & ﬂ ow selector“ in anticlockwise direction to ON position.

• Connect the accessory to the pressure outlet.

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

nected and the accessory outlet is secured.

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

instance pulmonary ventilator that requires gas ﬂ ow 100 l/min at the minimum pressure 2.8

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

teristics of the combination valve stated in appendix Nr. 1. To assure su cient performance

(pressure and ﬂ ow characteristics of the combination valve ) the medical device should not be

used if the content indicator of Manómetro Digital Display enters the red zone..

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

shocks. Insu cient opening of the shut-o valve could reduce 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 pressure in the cylinder is below 50 bar, in could adversely a ect

the outlet parameters of the combination valve .

7.1.3. AFTER USE

1. Turn the combination Combination Control Knob ‘Shut-oﬀ valve & Flow Selector’ ‘D’ in a

clockwise direction to the OFF position. Do not use excessive force. Do not use excessive force

(Maximum recommended closing torque is 3 Nm).

2. Vent pressure from the connected devices.

3. Disconnect all connected devices from user outlets.

4. Reﬁ t pressure outlet and ﬂ ow outlet protection cap (if available).

(Before reﬁ tting the caps, ensure they are clean).

8. 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.

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.

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9. CLEANING

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

of external surface can be carried out with an alcohol-based solution (with damped 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).

Do not use cleaning solutions containing ammonia!

Do not expose to water or any other liquid.

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

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

combination valve and cause contamination or damage.

Do not use pressure wash 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 withdrawn from service.

10. SERVICE, PRODUCT LIFE TIME AND MAINTENANCE

10.1. PRODUCT LIFE TIME

Serial number and manufacture date

An eleven-ﬁ gure serial number stamped on valve body consists of the data as follows:

YYYYMMXXXXX

YYYY: year of manufacture

MM: month of manufacture

XXXXX: sequence number of product

For example: Serial number 20151001521 indicates the valve manufactured in 2015, in

October, with sequence number 1521.

Product life time and waste management

Maximum operating life time of this product is 15 years from date of service commencing.

Maximum storage time for the product without use is 2 years. Storage conditions must be in

compliance with IFU.

At the end of the product’s life time, the product must be withdrawn 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“.

In accordance to Article 33 of REACH GCE, s.r.o. as 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. 231-100-4, CAS no. 7439-92-1. The lead will not be released to the gas

or surrounding environment during normal use. After end of life the product shall be scrapped

by an authorized metal recycler 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.

13/56

10.2. REPAIR AND SERVICE OPERATIONS

Repairs and service can be only done by a GCE certiﬁ ed person who also holds all necessary

certiﬁ cates in compliance with national standards for mounting and repair of dedicated gas

devices.

For information about a service in your area please contact GCE or distributor of GCE product.

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

Repair that do not need to be done by certiﬁ ed personnel include exchange of the below

mentioned components:

• guard,

• labels,

• protective covers and separable hose adaptors.

No parts of the equipment shall be serviced whilst in use with the patient.

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

user during the entire product life time.

Use only genuine GCE components.

Any product sent back to GCE (or GCE authorised centre) for repair or maintenancea 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 nr. should

be indicated.

11. TECHNICAL INFORMATION

The device Manómetro Digital compiles with the following electrical standards

Electrical safety: EN 60601-1 as amended

EMC: EN 60601-1-2 as amended

Ingress protection: EN ISO 60529, IP 65

The valve E-Ministar is adequate for use in hospital and ambulance care, etc. Avoid use in

the vicinity of devices with high intensity of electromagnetic disturbance, such as magnetic

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

would lead to increase of EM emissions or decrease of EM endurance of the device. Essential

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

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

Medical electrical devices require special safety measures concerning electromagnetic com-

patibility 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 medi-

cal devices.

The Manómetro Digital may be interfered with by other equipment, even if that other equip-

ment complies with CISPR emission requirements.

The Manómetro Digital should not be used adjacent to or stacked with other equipment. If

adjacent or stacked use is necessary, the E-Ministar should be observed to verify normal op-

eration in the conﬁ guration in which it will be used.

The device provides indication only and is not intended to provide monitoring or alarm func-

tions in a life-sustaining context. The monitoring functions can fail without producing an unac-

ceptable risk and therefore the device does not contain any essential performance which is

required to be maintained under fault conditions.

14/56

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 E - Ministar Other-

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

12. GLOSSARY

Consult instruction for use Suitable for Hospital care use

Caution! Suitable for Emergency care

use

Keep away from heat and

ﬂ ammable materials. Fragile, handle with care

Keep away from oil and

grease! Weight of product

Keep dry! Atmospheric pressure limit

Humidity level Use by date

Temperature limit SN Serial number

Inlet parameter

REF

Catalogue number

Outlet parameter

LOT

Batch code

P1Inlet pressure

REF 1

Customer number

P2Outlet pressure Take the equipment back for

recycling. Do not dispose

equipment into unsorted

municipal waste.

Manufacturer

Date of manufacture IP65

Degree of protection against

foreign bodies and water

13. 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.

15/56

APPENDIX:

Nr 1 – Technical and performance data

Nr 2 – Quick-coupler features and connecting/disconnecting procedure

Nr 3 – Post Filling Checks

Nr 4 – Valve assembly and ﬁ lling instruction

Nr 5 – Assembly and functionality status of EMM-O2

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. INTRODUCCIÓN

Este producto cumple los requisitos esenciales de la Directiva 93/42/CEE relativa a los

productos sanitarios, la Directiva 2010/35 EU sobre equipos a presión transportables y CDG

TPE (Amendment) & (EU Exit) Regulations 2020. El diseño de la válvula combinada se ajusta a

las normas EN ISO 10524-3.

TÉRMINO SIGNIFICADO

EMINISTAR Manorreductores integrados en la válvula de la botella equipada con

EMM O2-X.Y.ZZZ y protección.

EMM O2X.Y.ZZZ Módulo Clínico Electrónico para oxígeno conectado a un sensor E-

Ministar que actúa como indicador de llenado de gas.

También denominado Manómetro Digital.

El número X.Y.ZZZ se reﬁ ere a la versión de hardware y software.

LCD Pantalla de cristal líquido

2. USO PREVISTO

Las válvulas combinadas E-Ministar provistas de Manómetro Digital y protección están

pensadas para uso con botellas de gases de uso clínico. Estas válvulas combinadas forman un

paquete junto con la botella de gas que se utilizan bien para el suministro de gas de equipos

médicos (aparatos de anestesia, respiradores artiﬁ ciales, incubadoras, etc.), o bien para el

suministro directo de gas a una mascarilla o cánula de respiración del paciente.

Las válvulas combinadas GCE sirven para los siguientes gases de uso clínico:

• Oxígeno

• Óxido nitroso

• Aire de respiración

• Helio

• Dióxido de carbono

• Xenon

• Mezclas de los gases anteriores

2.1. PERFIL DE PACIENTE

La válvula de regulación obtiene caudales de 0 a 15 litros por minuto. La información acerca

de la especiﬁ cación del caudal puede encontrarla en el Apéndice n.º 1 de estas Instrucciones

de uso. El caudal se recoge en el Apéndice n.º 1 de estas Instrucciones de uso en la tabla de la

posición C, suministrándose este Apéndice con todos los productos.

La saturación del gas debe estimarla un facultativo o anestesista. Ellos disponen de la formación

necesaria por la que deben conocer el estado de salud del paciente y así poder ofrecerle el

importante soporte de los gases de uso clínico.

Estado de salud - se utiliza cuando el paciente necesita el soporte de gases medicinales para la

respiración y la decisión del tratamiento es cosa del facultativo o del personal sanitario.

Salud personal - el personal de enfermería, asistente de primeros auxilios, paramédico,

cuidador o persona con formación médica.

2.2. PERFIL DEL USUARIO

Uso en un hospital o ambulancia.

• Formación: persona con formación médica.

• Conocimiento: formación recibida de personas con formación médica, capacidad de leer,

estudiar y comprender el manual del usuario.

• La formación se proporciona de conformidad con las leyes aplicables en los diferentes países.

ESPAÑOL

INSTRUCCIONES DE USO: EMINISTAR

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3. REQUERIMIENTOS OPERACIONALES, DE TRANSPORTE Y

DE SEGURIDAD DE ALMACENAJE

Mantenga el producto y sus accesorios alejados de:

• fuentes de calor (fuego, cigarrillos, …),

• materiales inﬂ amables,

• aceite o grasa, (incluyendo cremas de manos),

• agua,

• polvo.

No deje caer el producto y evite siempre que sea posible cualquier caída del producto y sus

equipos agregados.

Mantener siempre los estándares de limpieza para el oxígeno.

Usar el producto y sus accesorios únicamente en áreas bien ventiladas.

Antes de su primer aplicación debe estar el producto en su embalaje original. En caso de ser

retirado el producto del servicio (a causa del transporte, del almacenaje), GCE recomienda usar

el embalaje original (incluso los materiales para llenar el inerior).

Es necesario observar las leyes nacionales, los reglamentos y regulaciones para gases

medicinales, la prevención de accidentes y la protección del medio ambiente.

CONDICIONES DE USO CONDICIONES DE ALMACENAJE

Y TRANSPORTE

-20* / +65** °C -40 / +70 °C

10 / 100 % 10 / 100 %

600 / 1200 mbar 600 / 1200 mbar

*A efectos de la estanqueidad interna de la válvula de corte la temperatura mínima no debe

descender de -40 °C al transportar y almacenar la válvula combinada montada sobre la botella.

** La temperatura máxima de contacto del cilindro es de + 45 °C.

Si se almacena la válvula combinada a una temperatura inferior a -20 °C, no se deberá usar la

válvula antes de que la temperatura haya ascendido a -20 °C como mínimo.

En el caso de las válvulas combinadas aptas para mezclas de O2 y N2O, la temperatura

mínima de funcionamiento es +5 °C. En el funcionamiento normal de la válvula combinada

puede formarse escarcha en su superﬁ cie, por el efecto de refrigeración que se produce en

el interior de la válvula combinada, por el paso del gas de alta presión a baja presión (efecto

Joule-Thomson). Por ello, se veriﬁ cará que todas las conexiones de un equipo a la válvula

combinada, y que estén además en contacto con un paciente, se hagan mediante una man-

guera de 2 m de longitud como mínimo.

Las mezclas de O2 y N2O son sensibles a la temperatura, pues el N2O empieza a separarse

de la mezcla cuando la temperatura desciende de -6 °C. Se puede volver a obtener una mez-

cla homogénea elevando la temperatura por encima de 10 °C y agitando la botella. Antes de

usarla y para asegurarse de que el contenido está debidamente mezclado, la botella se debe

mantener almacenada en posición horizontal durante 24 horas a una temperatura superior

a 10 °C. Si esto no es viable, antes de ser usada la botella se mantendrá a una temperatura

superior a 10 °C durante al menos dos horas y, a continuación, se invertirá por completo tres

veces; como método alternativo, se introducirá en agua caliente a temperatura corporal du-

rante cinco minutos, para a continuación ser invertida por completo tres veces.

18/56

4. INSTRUCCIONES PERSONAL

Según la directiva 93/42/EEC para dispositivos médicos, el propietario del producto deberá

asegurarse, que todos los usuarios tengan las instrucciones de uso y los datos técnicos.

No utilice el producto sin familiarizarse debidamente con el producto y su funcionamiento

seguro, así como se deﬁ ne en las Instrucciones de uso. Asegúrese de que el usuario tenga la

información adecuada y el conocimiento requerido para el gas utilizado.

5. DESCRIPCIÓN DEL PRODUCTO

La válvula combinada combina el funcionamiento de una válvula de corte para botella de gas a

alta presión y el de un regulador de presión para el empleo de gases de uso clínico. El gas de

la botella se controla en primera instancia con la válvula de corte principal, a continuación pasa

a través del regulador de presión y se suministra ﬁ nalmente al paciente a través de la descarga

de caudal o de la descarga de presión. La presión de suministro positiva la ﬁ ja el fabricante;

todas las válvulas combinadas están equipadas con una válvula de seguridad de baja presión

para protegerlas de la avería del regulador de presión.

El sistema se ofrece con dos alternativas básicas:

• Descarga de la válvula a través de boquillas calibradas; el caudal de descarga se puede

modiﬁ car mediante un regulador.

Descarga de la válvula mediante acoplamiento rápido (el caudal de descarga es constante) en

combinación con una descarga a través de boquillas calibradas que permiten regular el caudal

de la descarga mediante un regulador.

A  TOMA DE ENTRADA

La válvula combinada se acopla a la botella de gas mediante una toma de rosca. La rosca

puede ser cónica o paralela, de distinto calibre en función del tamaño y material de la botella.

Conﬁ guración habitual de E-Ministar (sin protección ni Manómetro Digital)

19/56

B  BOQUILLA DE LLENADO

La válvula está equipada con una boquilla

de llenado para rellenar la botella de

gas en una estación de llenado; no tiene

ninguna función relacionada con el

paciente. Esta boquilla está provista de

una válvula anti retorno, lo que implica

que se necesitan adaptadores de llenado

especiales para purgar el gas de la botella

durante el proceso de llenado (ventilación

o vacío de las botellas).

C PANTALLA E_INDICATOR EMM

O2_X.Y.ZZZ

La Manómetro Digital indica la cantidad

de gas que queda en la botella, así como

el tiempo restante hasta el vaciado total

de la botella, en función del caudal actual.

«X.Y» es un código que identiﬁ ca la

versión del hardware (X) y la versión del

software (Y). «ZZZ» es una codiﬁ cación

de la presión de admisión para la que se

utilizará la Manómetro Digital.

Si desea más información, consulte el

capítulo 6, Manómetro Digital.

D  MANDO COMBINADO DE VÁLVULA DE CORTE Y SELECTOR DE CAUDAL

La válvula está provista de un mando combinado para apertura/cierre y regulación de caudal.

La válvula se activa girando el mando en sentido antihorario de la posición OFF a la posición

ON. Para regular el caudal a un valor determinado se continúa girando en sentido antihorario.

La válvula de corte se cierra girando en sentido horario a la posición OFF.

E  VÁLVULA DE PRESIÓN RESIDUAL

La válvula combinada GCE está provista de una válvula de presión residual que sirve para

mantener una presión positiva mínima en la botella de gas, con objeto de evitar la contaminación

del interior de la botella con aire atmosférico. Cuando se realiza la ventilación del gas de la

botella a través de la toma de llenado, se bypassea la válvula de presión residual.

F, G  REGULADOR DE CAUDAL F Y DESCARGA DE CAUDAL G OPTATIVO

La válvula combinada se puede entregar con un regulador de caudal, F, cuya función es el

suministro de un caudal de gas regulable (l/min) a presión atmosférica directamente al paciente

a través de la descarga de caudal G, por ejemplo, mediante una cánula o una mascarilla. La

descarga de caudal G dispone de un acople para manguera (tipo boquilla) o una conexión

roscada (para accesorios que se conecten mediante rosca).

Es normal que la descarga de caudal G se mueva, debido a como está sujeta al cuerpo, esto no

indica que exista ningún tipo de avería.

H  DESCARGA DE PRESIÓN  ACOPLAMIENTO RÁPIDO O VÁLVULA DE PURGA

OPTATIVO

La descarga sale directamente de la sección de baja presión de la válvula y está provista de un

conector de acoplamiento rápido o de una válvula de purga.

Si se usa el acoplamiento rápido (véase el apéndice 2) el usuario puede conectar otro equipo al

acoplamiento rápido con un acople macho especíﬁ co de cada gas. Si se produce la desconexión

el conector de acoplamiento rápido se cierra por sí mismo. Esta descarga sirve para suministrar

gas a una presión controlada a aparatos clínicos, como por ejemplo respiradores artiﬁ ciales.

La válvula sin acoplamiento rápido está provista de válvula de purga para ventilar la presión

residual de la sección de baja presión de la válvula.

Conﬁ guración habitual de E-Ministar

20/56

I  DISCO DE RUPTURA

El disco de ruptura se sitúa por encima de la válvula de presión residual, E. Se trata de un

dispositivo de seguridad que evita que se produzca una presión excesiva en la sección de baja

presión de la válvula.

J  PROTECCIÓN POR EXCESO DE CAUDAL O TUBO BUZO OPTATIVO

La protección por exceso de caudal garantiza que se produzca la ventilación del gas de la

botella en caso de rotura de la válvula combinada por encima del conector de entrada (es

decir, por caída de la botella). El tubo buzo no tiene esta misma función. Tanto la protección

por exceso de caudal, como el tubo buzo sirven para evitar la contaminación procedente de la

botella de la válvula combinada.

K  DISPOSITIVO DE SEGURIDAD DE LA SECCIÓN DE ALTA PRESIÓN  DISCO DE RUPTURA

OPTATIVO

El disco de ruptura de alta presión sirve para proteger la botella y la sección de alta presión de

la válvula combinada de los daños que pueda causar un aumento de presión en la botella. Una

vez ha actuado el dispositivo de seguridad, éste no se vuelve a cerrar y la válvula combinada

se debe retirar del servicio para ser reparada. Dip tube also serves for ﬁ xing the sensor. El tubo

buzo también sirve para sujetar el sensor.

L _ PROTECCIÓN

La protección es una pieza integral del E-Ministar. Consta de dos mitades que se montan juntas

sobre la botella de gas. La Manómetro Digital se encuentra sujeta a una de estas mitades.

Nota: No es necesario que el color del producto (en especial la protección, el regulador de

caudal y la válvula de corte) cumpla la codiﬁ cación de colores de gases.

6. MANÓMETRO DIGITAL EMM O2X.Y.ZZZ

6.1. DESCRIPCIÓN DE LA MANÓMETRO DIGITAL

6.2. ADVERTENCIAS GENERALES E INFORMACIÓN IMPORTANTE DE

SEGURIDAD

La manómetro Digital no tiene piezas recambiables. En caso de fallo, devolver el conjunto de

gas completo al propietario.

En caso de caducidad de las baterías, no intente remplazarlas, devuelva el equipo al propie-

tario del paquete de gas.

El equipo no se debe someter a mantenimiento mientras lo esté usando un paciente.

Contraindicaciones: No hay contraindicaciones para el uso del Manómetro Digital porque se

utiliza únicamente con ﬁ nes de monitorización.

6.3. DESCRIPCIÓN GENERAL DEL MANÓMETRO DIGITAL

El manómetro digital proporciona al usuario una vista clara de la siguiente información:

• Contenido de gas del cilindro en litros (ltr). Este dato se muestra únicamente cuando la válvula

está cerrada y no hay caudal de gas, o bien cuando se está calculando el tiempo restante.

• Tiempo restante disponible del tratamiento al nivel de caudal de oxígeno actual. Esta

información aparece solo cuando la válvula está abierta y el gas ﬂ uye.

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