GCE E-MINISTAR Operating instructions

Type
Operating instructions
INSTRUCTION FOR USE
INSTRUCCIONES DE USO
VOD 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 PLYNOCH LAHVÍ
ES
CS
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).
D
F
A
I
G
H
E
B
J
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.
C
K
Typical E-Ministar confi guration
L
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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
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
1
/
/
IJ
KL M
N1
N2
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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:
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.
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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.
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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
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.
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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
Czech Republic © GCE, s.r.o.
1266
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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.
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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.
D
F
A
I
G
H
E
B
J
Confi guración habitual de E-Ministar (sin protección ni Manómetro Digital)
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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.
C
K
Confi guración habitual de E-Ministar
L
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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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GCE E-MINISTAR Operating instructions

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Operating instructions

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