gce mediline SABRE ELITE Series User manual

SABRE ELITE®SERIES
OXYGEN CONSERVING DEVICE
PRESSURE REGULATORS INTEGRATED WITH CYLINDER
VALVES
DRUCKREGLER MIT FLASCHENVENTILEN
DETENDEURS INTEGRES
REDUCEERVENTIELEN MET GEINTEGREERDE CILINDER
AFSLUITERS
INSTRUCTION FOR USE
BEDIENUNGSANLEITUNG
MODE D‘EMPLOI
EBRUIKSAANWIJZING
EN
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DE
FR
NL

ELITE ELV – M18x1,5
ELITE ELH – PI.O
ELITE ELH - BULL
ELITE BS PROBE

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FOREWORD
GCE SABRE ELITE® is medical device classied as class II b according
to the Medical Device Directive 93/42/EEC and Transportable Pressure
Equipment Directive 99/36/EEC.
Its compliance with the essential requirements 93/42/EEC Medical Device
Directive is based upon EN ISO 10524-3 standard.
INTENDED USE
The innovative ELITE oxygen conserving device conserves oxygen, and
thus prolongs the service life of the cylinder. Elite also increases the mo-
bility of the patient. Thanks to the system‘s precision metering, the O2
cylinders last approximately three-times longer than with simple pressure
regulators without conserving system, without any loss of therapeutic
effect.
ELITE offers major advantages:
• Ease of handling. Just screw a pressure regulator onto the cylinder,
turn the cylinder on, adjust the ow rate at the rotary switch and your
ready to go.
• No batteries required. You can save money, and potential sources of
error are removed.
• The special rotatable pressure gauge can be read easily from all
angles.
• No expensive special masks needed. Wear your normal standard nose
mask.
• The light weight, ease of handling and robust design offer the patients
optimum suitability for everyday use and maximum comfort
ELITE is delivered with a strapped carry bag Cylinder and Nasal Cannula.
Operational, transport and storage safety requirements
OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep the product and its associated equipment away from:
• heat sources (re, cigarettes,...),
• ammable materials,
• oil or grease (be careful in the use of tissues and creams),
• water,
• dust.
Do not drop or let the product falling down.
Always maintain oxygen cleanliness standards.
1.
2.
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Use only the product and its associated equipment in well ventilated
area
Before initial use the product will be supplied in its original packing. If
removed from service (for transport, storage) GCE recommend using the
original packaging (including inner packing materials).
The product owner or user must ensure that during the product life cycle
transport and storage environmental conditions are in accordance with
the above “Safety instruction” section requirements, in order to maintain
product integrity and cleanliness.
Statutory laws, rules and regulations for medical gases, accident preven-
tion and environmental protection must be observed.
OPERATING CONDITIONS STORAGE AND TRANSPORT
CONDITIONS
-20/+60 °C -20/+60 °C
10/95% 10/95%
600/1200 mbar 600/1200 mbar
In case of storage at a temperature below -20 °C, d o not operate the
regulator until it has been allowed to increase its temperature to a
minimum of -20 °C.
PERSONNEL INSTRUCTIONS AND TRAINING
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 and are fully trained in the use of the equipment.
Do not use the product without proper training! Trainees must be
trained by an experienced person who has been authorised by the
manufacturer and has an appropriate education, knowledge and
experience.
For further information about training of responsible personnel, please
contact GCE.
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PRODUCT DESCRIPTION AND TECHNICAL
PARAMETERS
5.1. PRODUCT DESCRIPTION
ELITE® combines the function of a shut-off valve for a high-pressure gas
cylinder (available only on the Combination valve type) and a medical
pressure regulator with gas economizer. Gas from the cylinder is rst con-
trolled by the main shut-off valve (available only on the Combination valve
type) and then passes through the pressure regulator via a ow selector
and pulse gas economizer then is nally supplied to the patient.
The pressure regulator is a single-stage piston one, controlled by a gov-
erning spring. Outlet positive pressure is xed by the manufacturer and
each valve is provided with a pressure relief valve to avoid exceeding of
outlet positive pressure.
The quantity of medical gas supplied to the patient can be selected by
means of a rotary ow selector control knob.
ELITE® enables dosing of supplementary oxygen and thus provides a
longer dwell time of the cylinder. This is achieved by supplying oxygen in
so-called pulses, which is much more efcient than constant ow.
During exhalation, oxygen is collected in the reservoir. At the beginning of
inhalation, negative pressure is detected by a membrane and this enables
turning on the valve and oxygen is supplied to the patient at the beginning
of inhalation. Oxygen is supplied in a close relationship to a conventional
method of constant ow through various ranges of respiratory rates.
This device automatically adapts oxygen supply to respiratory rate of the
patient. A higher respiratory rate means less time for oxygen collecting in
the reservoir. Thus the patient gets smaller pulses with a higher frequen-
cy. A lower respiratory rate of the patient means more time for oxygen
collecting. Thus the patient gets bigger pulses with a lower frequency.
At the beginning of therapy, the rst pulse can be bigger in com-
parisonwithsubsequentpulsesduetothepossibilityofafullylled
reservoir and therefore the maximum possible oxygen volume is
supplied to the patient. Subsequent pulses then depend on respira-
tory rate of the patient.
A long inhalation can also be accompanied by other secondary puls-
eswiththelowervolumethantherstpulseduetoaquickopening
andalackoftimeforthereservoirrelling.
Oxygen supply occurs at the beginning of inhalation when the gas is
mixed with ambient air directed to the lungs where it is absorbed. During
a later inhalation phase (when otherwise oxygen is to be directed to “dead
spaces”) and during exhalation, the gas is economized by means of its
collecting in the reservoir.
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Efciency of this device is about 90% - 70%; it is calculated based on nal
oxygen quantity supplied to the lungs in comparison with constant ow
where efciency is only 20% - 40%.
The oxygen economization factor of this device is particularly derived
from efciency; however other factors are also relevant. This device has
an economization factor approx. 3 based on oxygen supply efciency.
If further incremental economization of broad range of adjustment com-
plies with the patient’s need and it is taken for the benet of total gas
economization, the total gas economization factor can be about 4.8
(3x1.6).
1 - Inlet stem
The product is tted to gas cylinder by a threaded inlet stem. The stem
can be taper threaded or parallel threaded and of different size depending
upon cylinder size and material.
2 - Shut-off valve
The combination valve is provided with a shut-off valve to isolate the gas
from the cylinder, from the other valve functions and ensure retention of
gas in the cylinder. It must be turned on during cylinder lling and patient
therapy
3 - Filling port
Filling port is provided for lling the gas cylinder. It includes a non-return
valve (NRV). The NRV means that special lling adaptors are required to
prevent depressurizing during the use of the product.
4 - Pressure gauge
Pressure gauge enables checking of the gas cylinder contents; it can
be rotated about its axis for easier reading of the cylinder contents. The
pressure gauge can be either active or non-active one.
• active pressure gauge enables checking gas pressure at shut-off valve
in the OFF position
• non-active pressure gauge enables checking gas pressure at shut-off
valve in the ON position only.
5-ECONowcontrolhead
Flow control head is used to control ow and pulse dosing of gas at at-
mospheric pressure directly to the patient through the ow outlet (9). Pos-
sible ow rates are equivalent to constant gas ow rates (l/min). These
ow rates are set by the manufacturer.
6 - Flow selector
Turning the ow selector enables selection of possible set ow rates that
are equivalent to constant ow rates in l/min.
7 - Reservoir
Enables gas collection before its supply to the patient.

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8 - Membrane guard / membrane
Enables to activation of the valve at induced negative pressure and sub-
sequent gas supply to the patient.
9 - Outlet stem
Universal outlet stem is designed for connection of other accessories
(cannula, breathing mask etc.).
7
1
5
6
89
7
1
5
6
89
4
3
2
7
5
6
89
1
4
7
5
6
89
4

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5.2.TECHNICAL SPECIFICATION
NAME ELITE ELH
(BULL NOSE,
PIN INDEX)
ELITE ELV
(COMBINATION
VALVE)
ELITE BS
(QUICK
COUPLER)
Type of regulator
High pressure
regulator without
shut-off valve
High pressure
combination valve
regulator
Low pressure
regulator without
pressure gauge
Inlet pressure 13,5-200 bar 13,5 - 200 bar 3,9 - 6 bar
Type of inlet
connection
High pressure inlet
connection
High pressure inlet
connection
Low pressure quick
coupler connection
Pressure gauge 0-200 bar 0-200 bar N/A
Therapy ow
accurancy
10% for gas ows
over 1l/min
10% for gas ows
over 1l/min
10% for gas ows
over 1l/min
20% for gas ows
under 1l/min
20% for gas ows
under 1l/min
20% for gas ows
under 1l/min
Outlet pressure: max. 4,2 bar max. 4,2 bar max. 1,6
Therapy outlet Universal
‘r-tree’ type.
Universal
‘r-tree’ type.
Universal
‘r-tree’ type.
Max. nominal gas
ow Pulse Pulse Pulse - see table below
Gas ow setting See table below See table below See table below
Inlet connection
thread
Depends on the
type of gas cylinder
which it is designed
for.
Depends on the
type of gas cylinder
which it is designed
for.
N/A
Denomination
of the gas
ow on the
label
1.0 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0
MIN. GAS
FLOW 0.45 0.52 0.61 0.76 0.92 1.7 1.23 1.38 1.54 1.69 1.85 2.00
MAX. GAS
FLOW 0.52 0.59 0.70 0.88 1.6 1.23 1.41 1.59 1.77 1.95 2.13 2.30

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INSTALLATION
6.1. CHECKS BEFORE INSTALLATION
Installation of the device must be done by a service person authorized
by the manufacturer and according to the instructions provided by the
manufacturer.
• Check if there is visible damage to the device and gas cylinder
(especially the lead-in thread of the valve and of the gas cylinder). If
it shows signs of external damage, remove the device or gas cylinder
from service and appropriately identify its status.
• Visually check the device thread for possible contamination; if
necessary, use the cleaning procedure detailed in this IFU (for gas
cylinders, refer to the cylinder manufacturers cleaning procedure).
• Check if the service due or that the total life time of GCE product and
the gas cylinder has not been exceeded – see Chapter 9. If service
or total life time has been exceeded, remove the GCE product from
service & suitably identify its status.
• Ensure that the product inlet stem is compatible with the medical gas
cylinder (gas/ thread type). Always follow instruction for use for certain
type of cylinder.
• Check the presence & the integrity of seals / sealing materials (PTFE
tape, O-ring) on inlet stem.
• Gas cylinder pressure rating must be at least equal to or greater than
the rated combination valve inlet pressure.
The product is designed only for use with the gas specied in its
labelling.Nevertrytottheproductongascylinderforadifferent
gas.
Take care not to damage external components i.e. pressure gauge.
6.2. INSTALLATION OF THE ELITE COMBINATION VALVE
TYPE
• Tighten Inlet stem thread (1) using the square surfaces on combination
valve body.
• Do not exceed the maximum torque allowed for the cylinder. Too high
torque may damage the valve thread preventing reuse. Certain types of
cylinders may require a torque lower than stipulated in EN ISO 13341.
Check torque value with your cylinder supplier.
Multiple installation or removal can damage inlet stem thread. other
parts of the product.
6.

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6.3.INSTALLATION OF THE ELITE PIN INDEX AND BULL-
NOSE VERSION
Fit the Elite to the cylinder valve, tightening the yoke screw or hand -
wheel rmly by hand.
NOTE: Using excess force or tools to tighten the cylinder connector
may damage the connector. If in double, please call GCE or your
distributor.
OPERATION
7.1. BEFORE USE
The following operations are undertaken by the owner (operator) of
the device, trained hospital staff, or emergency care staff, or trained
supplier ensuring delivery of the complete medical package to the
user, patient.
Shut off valves should always be opened slowly. Sudden opening
could result in a danger of re or explosion arising from oxygen
pressureshocks.Insufcientopeningoftheshut-offvalvecouldre-
duceactualowdelivered.
• Check if there is visible damage on the medical gas primary package
(including product labels and marking). If it shows signs of external
damages, remove the product from service and suitably identify its
status.
• Visually check if the medical gas primary package is contaminated; if
needed, apply the cleaning procedure hereunder.
• Turn-off the shut-off valve by turning the hand wheel in a clockwise
direction to ZERO position. Do not use excessive force.
• Remove caps. Always keep removed caps in a safe place for reuse
during transport or storage.
7.1.1. LEAK-TIGHT CHECK BEFORE USE
Slowly open the combination shut-off valve (2) or cylinder shut off valve
by turning the hand wheel in anticlockwise direction approx 1 to 1½ turns.
Visually and audibly check possible leakages from:
• ow outlet
• lling port
• pressure gauge
• shut-off valve (2)
• the lower part of ow control knob (pressure relief valve venting)
Alwaysensurethattheowcontrolknobhasbeenengagedandnot
placedbetweentwosettingsotherwisetheowcontrolheadwillnot
7.

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delivercorrectoranyowofmedicalgas.
Somevariants ofowcontrolheadcan havean“end stop”inbe-
tweenthemaximumowpositionandtheposition„1“.Donottryto
applyexcessivetorqueontheowcontrolknobwhenitstopsonthe
maximumowposition(duringclockwiserotation)orinposition„1“
(anti-clockwise position).
Theowrateofmedicalgasmustbeprescribedandprovidedbya
clinically trained user.
Cylinder duration table:
This table gives you an idea of an approximate duration in hours: minutes
for Elite
Cylinder
capacity
(litre)
Pressure
(bar)
Flow equivalency setting (L/min)
12346
0,5 137 3:25 1:42 1:08 0:51 0:34
1,5 137 6:51 3:25 2:17 1:42 1:08
1,7 137 11:38 5:49 3:52 2:54 1:56
2,0 137 13:42 6:51 4:34 3:25 2:17
2,7 137 18:29 9:14 6:90 4:37 3:40
9,4 137 64:35 32:17 21:31 16:08 10:45
0,5 200 5:00 2:30 1:40 1:15 0:50
1,0 200 10:00 5:00 3:20 2:30 1:40
1,7 200 17:00 8:30 5:40 4:15 2:50
2,0 200 20:00 10:00 6:40 5:00 3:20
2,7 200 27:00 13:30 9:00 6:45 4:30
9,4 200 94:17 47:80 31:26 23:34 15:43

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7.2.AFTER USE
• Remove the nasal cannula from the patient.
• Turn off at the shut-off valve (2) or cylinder shut-off valve by turning
the hand wheel in a clockwise direction. Do not use excessive force
(Maximum recommended closing torque is 2 Nm).
• Disconnect the tube from the ow outlet.
• Ret pressure outlet and ow outlet protection cap. Before retting the
caps, ensure they are clean.
• Return, recharge or replace empty cylinder.
7.3. REFILLING THE CYLINDERS
7.3.1. ELITE®COMBINATION VALVE TYPE
GCEllingadaptors
GCErecommendsusingGCEllingadaptors;NonGCEllingadap-
torscandamagethenon-returnvalveinthellingportandimpact
the safety of the product.
Contact GCE for further information.
Visualinspectionbeforelling
Remove protective caps from the lling port. Keep the caps in a safety
place for reuse in transport or storage.
• Check if there is visible damage on the product, its parts and lling
adaptor. If it shows signs of external damage, remove it from service
and suitably identify its status.
• Visually check if the product, its parts, especially lling port and lling
adaptor is contaminated; if necessary, use the cleaning procedure
detailed in this IFU (For the medical gas cylinder and the lling adaptor,
refer to the cylinder manufacturer for cleaning procedure if needed).
• Check if the service or that the total life time of GCE product and gas
cylinder has not been exceeded – see Chapter 9. If service or life time
has been exceeded, remove the product from service & suitably identify
its status.
• Ensure that the combination valve lling port is compatible with the
lling adaptor (gas/type).
• The lling pressure (settled pressure at 15°C) shall not exceed rated
combination valve inlet pressure.
Filling adaptor connection
• Observe oxygen cleanliness standards during lling.
• Connect a genuine GCE lling adaptor. Do not use excessive torque
when connecting the lling adaptor (15Nm max).
GCE do not recommend using power drivers or impact drivers to
connect lling adapter (excessive force & shocks could result in

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damage to the lling port). Contact GCE to ensure that the lling
port features on your product are compatible with power drivers or
impact drivers.
Medical Gas Package Filling
If the combination valve is used to dispense medical gases within the EC,
only gases which have been manufactured according to the requirement
of Good Manufacturing Practice (GMP), detailed in the EC Good Manu-
facturing Practice guide and dened in EC Directive 91/356EEC Annex 6
should be used. Further guidance can be found in EIGA document IGC
Doc 99/03/E Good Manufacturing Practice Guide for Medical Gases.
• Prior to lling carry out checks (refer to appendix nr. 3 “Pre / Post lling
checks”).
• During lling, the shut-off valve must be fully turned on (On).
• After lling ensure that the shut-off valve is closed (Off). When
turning off at the shut-off valve do not use excessive force (Maximum
recommended closing torque is 2 Nm).
• The lling line (including the lling high-pressure hose) must be vented
prior to disconnect the lling adaptor).
Filling adaptor connection
• Observe oxygen cleanliness standards during lling.
• Connect a genuine GCE lling adaptor. Do not use excessive torque
when connecting the lling adaptor (15Nm max).
7.3.2. ELITE®PIN-INDEX AND BULL-NOSE TYPES
Remove the device from the cylinder and send bottle for rell or exchange.
Removal of the ELITE®device can be done ONLY by the person by
GCE person or person authorized by GCE.
CLEANING
Remove dirt with a soft cloth damped in oil free soap water & rinse with
clean water. Cleaning agents must comply with oxygen cleanliness
standards.
Disinfection can be carried out with an alcohol-based solution (spray or
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.
Do not use cleaning solutions containing ammonia!
Do not expose to water or any other liquid.
Do not expose to high temperature (such as an autoclave).
Do not pack the product until completely dry.
8.

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SERVICE, PRODUCT LIFE TIME AND
MAINTENANCE
9.1. SERVICE PERIOD AND PRODUCT LIFE TIME
Serial number and manufacture date
An eight-gure serial number is stamped on valve body consists of the
data as follows:
M RR XXXXX
M: month of manufacture
RR: year of manufacture
XXXXX: sequence number of product
For example: Serial number A1000521 indicates the valve was manufac-
tured in 2010, In January, with sequence number 521.
Service period
Maximum time in operation for the GCE combination valves before Over-
all Maintenance is 5 years from the manufacturing date.
At the combination valve type, GCE also recommends that the products
removed from the gas cylinder undergo Overall Maintenance.
The device must be serviced by the date marked on the waist label.
It should not be assumed that Pre / Post Filling Checks (refer to Appendix
nr 3) and Overall Maintenance covers every safety procedure or method
required by local regulations, or that abnormal unusual circumstances
may not warrant or suggest further requirements or additional procedures.
Contact GCE for further information on the qualication program for cus-
tomised service period.
Product life time and Waste management
Maximum life time of the product is 10 years from the manufacturing date.
At the end of the product’s life time (10 years maximum), the product
must be withdrawn from service. The owner of the device shall prevent
the reuse of the product and handle the product in compliance with “Di-
rective of European Parliament and Council 2006/12/ES of 5th April 2006
9.

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on waste“.
9.2. MAINTENANCE, REPAIR AND SERVICE OPERATIONS
Pre/PostllingChecks
Functional and leak-tight checks before and after each lling are recom-
mended. See Annex 3 for further instructions. Contact GCE if further in-
formation is needed.
Repair and overall maintenance
Overall maintenance consists of the preventive activities as follows:
• replacement of critical components,
• cleaning of reusable components,
• product retesting.
Repairs consist of corrective operations (i.e.: product known to be faulty).
Repair activities and overall maintenance of ELITE® must be carried out
by GCE or authorized repair centres. Contact GCE for further information
about service available in your area.
Repair activities of ELITE combination valve type can generally be per-
formed with the combination valve tted on the cylinder.
All labels on the equipment must be kept in good, legible condition
by the owner and the user during the entire product life time.
Use only genuine GCE components!
Any product sent back to GCE (or GCE authorised centres) for repair or
maintenance shall be properly packaged. Contact GCE for further infor-
mation about available maintenance packaging set.
The purpose of the maintenance shall clearly be specied (repair, overall
maintenance). For product to be repaired, a short fault description and
any reference to a claim nr. should be indicated.
9.3. ACCESSORIES AND SPARE PARTS
Always use the GCE original spare parts!
Accessories
ELITE® is delivered with a strapped carry bag Cylinder and Nasal Canulla.
On demand:
• GCE lling adaptors. GCE Recommends using GCE lling adaptors:
Non GCE lling adaptors can damage the non-return valve in the lling
port and impact the safety of the product.
• Elite - Trolley
Spare parts
For information about current spare part list, please contact GCE.

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GLOSSARY
Consult operating
instruction Suitable for Home care use
Caution Suitable for Hospital care
use
Keep away from heat and
ammable material
Suitable for Emergency
care use
Keep away from oil and
grease SN Product serial number
Upper and lower humidity
limit REF Catalogue number
Upper and lower
temperature limit LOT Batch number
Keep dry Fragile
Date of manufacture Manufacturer
Use by date Weight of product
Inlet parameter Outlet parameter
The date of service or use
The perforated number
indicates the year the
product has to undergo
the overall maintenance
activities or has to be
removed from service.
Refer to the serial number
to determine what has to
be done
Take the equipment back for
recycling. Do not dispose
equipment into unsorted
municipal waste.
LEP Life Extension Program
Ambient pressure limit
REF 1 Customer number
10.

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Manufactured by
GCE s.r.o. Tel : [phone]
Zizkova 381 Fax : [phone]
583 81 Chotebor http://www.gcegroup.com
Czech Republic © GCE s.r.o.
0434
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 In-
struction for use (IFU) and general industry good practice and standards.
11.

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VORWORT
GCE SABRE ELITE® ist ein Medizingerät, das als Klasse II b gemäß
der Richtlinie 93/42/EWG über Medizinprodukte und der Richtlinie
99/36/EWG über ortsbewegliche Druckbehälter eingestuft ist.
Der Einhaltung der Grundanforderungen der Richtlinie 93/42/EWG über
Medizinprodukte ist die Norm EN ISO 10524-3 zugrunde gelegt.
VERWENDUNGSZWECK
Modernes Gerät für die Sauerstoffaufbewahrung ELITE speichert den
Sauerstoff, und dadurch wird die Lebensdauer der Flasche verlängert.
Elite erhöht auch die Mobilität des Patienten. Dank der genauen Sys-
temdosierung weisen die Flaschen mit O2 eine ungefähr dreimal längere
Haltbarkeit auf, als mit einfachen Druckreglern ohne das Aufbewahrungs-
system, und zwar ohne dass die therapeutische Wirkung beeinträchtigt
wird.
ELITE bietet folgende Vorteile an:
• Leichte Manipulation. Es genügt, den Druckregler an die Flasche zu
schrauben, die Flasche zu öffnen, den Durchuss mit Drehschalter
einzustellen und das Gerät kann betrieben werden.
• Keine Batterien sind erforderlich. Dadurch wird das Geld gespart und
es entfällt auch die potentielle Störungsquelle.
• Die Angaben am speziellen Drehmanometer können von allen Winkeln
gelesen werden.
• Keine teuren speziellen Masken sind erforderlich. Tragen Sie Ihre
übliche Maske über Nase und Mund.
• Niedriges Gewicht, leichte Manipulation und beständige Konstruktion
machen das Gerät für den alltäglichen Gebrauch geeignet und bringen
den Patienten maximalen Komfort.
ELITE wird mit Flasche mit Traggurten und Nasenkanüle geliefert.
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SICHERHEITSANFORDERUNGEN AN BE-
TRIEB, TRANSPORT UND LAGERUNG:
Das produkt und die zugehörigen Geräte sind fernzuhalten von:
• Wärmequellen (Feuer, Zigaretten usw., …),
• brennbaren Materialien,
• Ölen oder Fetten (erhöhte Vorsicht bei Gebrauch der Mundtücher und
Handkremen),
• Wasser,
• Staub.
Sturz des Produkts vermeiden.
Es sind alle Vorschriften und Regelungen zur Sauerstoffreinheit
einzuhalten.
Das Produkt und die zugehörigen Geräte nur in gut belüfteten Räu-
men einsetzen.
Vor dem ersten Gebrauch muss sich das Produkt in seiner Originalverpa-
ckung benden. Im Falle der Außerbetriebsetzung (für Transport, Lage-
rung) empehlt GCE die Originalverpackung zu verwenden (inkl. innerer
Füllstoffe).
Der Besitzer oder Benutzer des Produkts hat sicherzustellen, dass wäh-
rend der Lebensdauer des Produkts, seiner Beförderung und Lagerung
die Umgebungsbedingungen die oben angegebenen Anforderungen der
„Sicherheitsvorschriften“ erfüllt werden, um die Produktintegrität und
-sauberkeit zu erhalten.
Nationale Gesetze, Verordnungen und Vorschriften für medizinische
Gase, Unfallverhütungs- und Umweltschutzvorschriften müssen einge-
halten werden.
BETRIEBSBEDINGUNGEN LAGER- UND
TRANSPORTBEDINGUNGEN
-20/+60 °C -20/+60 °C
10/95% 10/95%
600/1200 mbar 600/1200 mbar
Im Falle der Lagerung des Ventils unter -20 °C darf das Kombi-Ven-
til nicht eingesetzt werden, bis seine Temperatur wenigstens -20° C
erreicht.
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ANWEISUNGEN UND SCHULUNGEN FÜR
MITARBEITER
Gemäß Medizingeräteverordnung 93/42/EEC hat der Eigentümer des
Produkts sicherzustellen, dass alle Mitarbeiter, die mit dem Produkt um-
gehen, mit der Bedienungsanleitung und den technischen Daten des
Produkts vertraut sind und für jeden auszuführenden Arbeitsschritt aus-
reichend geschult wurden. Die Schulung muss von erfahrenen Personen
durchgeführt werden.
Wenden Sie das Gerät nicht an wenn Sie nicht geschult sind. Schu-
lungen können nur durch Personen mit angemessener Ausbildung,
Erfahrung und Kenntnis durchgeführt werden, die selbst durch den
Hersteller geschult wurden.
Falls Sie weitere Informationen brauchen, kontaktieren Sie GCE.
PRODUKTBESCHREIBUNG UND TECHNISCHE
PARAMETER
5.1. PRODUKTBESCHREIBUNG
ELITE® verbinden die Funktion von Absperrventilen für Hochdruckgas-
aschen (zur Verfügung nur beim kombinierten Ventiltyp) und medizini-
schen Druckreglern und Gassparern. Das aus der Flasche austretende
Gas strömt zunächst durch das Hauptabsperrventil (zur Verfügung nur
beim kombinierten Ventiltyp), anschließend durch einen Druckregler,
Durchussregler und Gassparer und wird schließlich dem Patienten
verabreicht.
Der Druckregler ist ein mit Regelungsfeder gesteuertes einstuges Kol-
benventil. Der Ausgangsüberdruck ist werksseitig fest eingestellt und ge-
gen unerwünschte Überschreitung des Ausgangsüberdrucks wird jedes
Ventil mit einem Sicherheitsventil ausgestattet.
Eine dem Patienten verabreichte Gasmenge kann durch den Durch-
uss-Drehregler ausgewählt werden.
ELITE® ermöglicht, eine Sauerstoffzusatzmenge zu dosieren und da-
durch einen längeren Flascheneinsatz sicherzustellen. Dies wird durch
die Sauerstoffdosierung in sog. Impulsen erreicht, was vielmehr effektiv
ist, als ein konstanter Durchuss.
Während des Ausatmens wird der Sauerstoff im Speicher gesammelt.
Am Anfang des Einatmens detektiert den Unterdruck die Membrane und
dies ermöglicht, das Ventil zu öffnen und Sauerstoff dem Patienten am
Respirationsanfang zu verabreichen. Der Sauerstoff wird in der nahen
Beziehung mit der traditionellen Methode des konstanten Durchusses
über verschiedene Atemfrequenzbereiche verabreicht.
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