GCE ELITE ELH BS PROBE User manual

GCE HEALTHCARE
PICTURE
GCE HEALTHCARE
ELITE OXYGEN CONSERVER
MODEL: ELH BS PROBE
EN
INSTRUCTION FOR USE

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EN
1. FOREWORD
GCE Elite ELH BS PROBE is a medical device classified as class II b
according to the Medical Device Directive 93/42/EEC.
It´s compliance with the essential requirements 93/42/EEC Medical Device
Directive is based upon EN ISO 10524-1 standard.
2. INTENDED USE
The Elite oxygen conserver delivers oxygen in pulses during oxygen
therapy.
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Follow the instructions of your medical practitioner, the instructions in this
leaflet and the instructions for any equipment used with the regulator to
ensure optimum patient care and safety.
DO NOT smoke near the unit at any time as oxygen encourages fire, even
in materials which do not normally burn in air.
DO NOT use oil, wax, polish, or grease on any part of Sabre Elite as they
may cause fire or explosion.
DO NOT use the unit if the ‘next service due’ date on the waist label has
passed.
Use only MEDICAL OXYGEN with Sabre Elite.
DO ensure that the cylinder is secure and cannot fall.
DO open and close cylinder valves slowly to avoid oxygen shock.
ALWAYS close the cylinder valve when you have finished using the Sabre
Elite
DO NOT tamper with the equipment, as this may endanger patients and
will invalidate the warranty.
ONLY use with a single lumen cannula.
ALWAYS check that the cannula is unkinked before use.
ALWAYS check that the Sabre Elite is undamaged before use.
DO NOT allow the Sabre Elite to get wet.
DO NOT cover the breathing hole on the back of the Sabre Elite with
labels.
ENGLISH
INSTRUCTION FOR USE: ELITE ELH BS PROBE

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DO ensure that the gas is vented from the Sabre Elite before removing
it from a cylinder.
If you are in doubt or require any guidance in the use of this product,
please contact your distributor or GCE.
Before initial use the product should be kept in its original packaging. GCE
recommends use of the original packaging (including internal sealing bag
and caps) if the product is withdraw from operation (for transport, storage).
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 -30/+60 °C
10/95% 20/70%
600/1200 mbar 600/1200 mbar
In case of storage at a temperature below -20 °C or above 60 °C do
not operate the medical device until it has been allowed to change its
temperature inside operating temperature limits.
4. PERSONNEL INSTRUCTIONS
According to Medical Devices Directive 93/42/EEC the product provider
must ensure that all personnel handling the product are provided with the
operating instructions & performance data and are fully trained to carry
out that operation. Trainees need to be supervised by an experienced
person.
Do not use the device without being trained. Training can be only done
by a person with an appropriate education, experience and knowledge
that has been also trained by the manufacturer.

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5. PRINCIPLE OF OPERATION
Gas supply: 3.9 bar to 6.0 bar
Therapy outlet: Universal ‘fir-tree’ type
Therapy flow accuracy: +/- 10%
Outlet pressure: 4.2 bar (61 PSI) nominal
Oxygen from the cylinder is reduced to a constant pressure and used to fill
a reservoir at a rate set by the flow setting knob.
During exhalation, there is no oxygen flow out of the unit, so the reservoir
fills up to a level determined by the flow setting.
As an inhalation begins, the small suction at the nose makes a valve open.
A timed pulse of oxygen is delivered from the reservoir to the patient. The
timing is designed so that inhaled gas flows deep into the lungs.
Flows are set so that the oxygen delivered into the lung will be approximately
equivalent to the same constant flow. Flows into the reservoir are about a
third of the flow setting. This, combined with the number of settings will
normally give increases in duration of 3 to 5.

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EN
6. USE OF PRODUCT
6.1. CHECKS BEFORE CONNECTION
• Check if there is visible damage to the device. If it shows signs of
external damage, remove the device from service and appropriately
identify its status.
• Visually check the device connection for possible contamination; if
necessary, use the cleaning procedure detailed in this IFU.
• Check if the service is due or that the total life time of GCE product 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 used medical
gas.
The product is designed only for use with the gas specified in its labelling.
Never try to fit the product on gas cylinder for a dierent gas.
Take care not to damage external components i.e. flow selector.
6.2. OPERATIONS
The following operations are undertaken by the owner (operator) of the
device, trained hospital sta, or emergency care sta, or trained supplier
ensuring delivery of the complete medical package to the user, patient.
Shut o valves should always be opened slowly. Sudden opening could
result in a danger of fire or explosion arising from oxygen pressure
shocks. Insucient opening of the shut-o valve could reduce actual
flow delivered.
ATTACHING TO A BS 5682 SOCKET
Insert the end of the BS probe into the oxygen socket until it locks into
place with an audible click. If fitted to a pressure regulator, ensure that the
gas is turned on before using the Elite.
PROVIDING LOW FLOW OXYGEN THERAPY
Push the nasal cannula over the ‘fir-tree’ therapy outlet and tug gently to
check that it is secure. Turn the flow selector knob until the flow setting,
stipulated by a medical/nursing practitioner, is displayed in the window of
the selector knob. Always follow the cannula manufacturer’s instructions
for proper use. To Connect the cannula to the patient, position the cannula
tips in the patients’ nostrils and pass tubing over both ears and under chin.
Once the cannula is secured, breathe normally through the nose.
Monitor the cylinder contents gauge, if fitted, regularly during therapy and
replace the cylinder when the contents gauge enters the red sector.
Ensure that the cannula remains in place throughout therapy. If it is
displaced no therapy will be provided. When a patient inhales, Elite can
be heard providing pulses of oxygen. During exhalation, or if the cannula
is displaced from the nose the unit is silent and there is no oxygen flow.

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EN
Note: The best oxygen savings will be obtained if there is one pulse per
breath. It is worth experimenting with positioning of the cannula in the
nose to achieve this.
Always ensure that the flow control knob has been engaged and not
placed between two settings otherwise the flow control head will not
deliver correct or any flow of medical gas.
Flow control head can have an “end stop” in between the maximum flow
position and the position „1“. Do not try to apply excessive torque on the
flow control knob when it stops on the maximum flow position (during
clockwise rotation) or in position „1“ (anticlockwise position).
The flow rate of medical gas must be prescribed and provided by a
clinically trained user.
6.3. AFTER USE
• Remove the nasal cannula from the patient.
• Turn o at the cylinder shut-o valve by turning the hand wheel in a
clockwise direction.
• Disconnect the tube from the flow outlet.
• Refit pressure outlet and flow outlet protection cap. Before refitting the
caps, ensure they are clean.
7. ACCESSORIES AND SPARE PARTS
Always use the GCE original spare parts!
Accessories:
For information about current Accessories, please contact GCE.
Spare parts:
For information about current spare part list, please contact GCE.
8. CLEANING
DO NOT dismantle the unit.
DO NOT allow moisture to enter the unit.
DO NOT use polish including spray polish, oil, or any other cleaning
agent or lubricant.
Dust the exterior surfaces with a clean dry lint-free cloth.
A clean, slightly moist, lint free cloth may be used to remove persistent
marks.
DO NOT pack the equipment until completely dry.
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).

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To apply the cleaning solution do not spray it as the spray may enter into
the inner parts of product and cause contamination or damage.
DO NOT use pressure wash as it could damage or contaminate the
product.
If the inner parts of the product have been contaminated DO NOT
continue to use the product under any circumstances. It must be
withdrawn from service.
9. SERVICE, PRODUCT LIFE TIME AND
MAINTENANCE
9.1. PRODUCT LIFE TIME
9.1.1. SERIAL NUMBER AND DATE OF PRODUCTION
An eight-figure 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
Month:
A January
B February
C March
D April
E May
F June
G July
H August
I September
J October
K November
L December
For example: Serial number A1000521 indicates the valve was manufac-
tured in 2010, In January, with sequence number 521.
9.1.2. 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 “Directive of
European Parliament and Council 2006/12/ES of 5th April 2006 on waste“.

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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 valve bodies and
other brass components contain 2-3% of lead (Pb), EC no. 231-468-6, CAS
no. 7439-92-1. The lead will not be released to the gas or surrounding
environment during normal use. After end of life the product shall be
scrapped by an authorized metal recycler to ensure e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.
9.2. REPAIR AND SERVICE OPERATIONS
Repairs and service can be only done by a GCE certified person who also
holds all necessary certificates 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.
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
information about available maintenance packaging set.
The purpose of the maintenance shall clearly be specified (repair, overal
maintenance). For product to be repaired, a short fault description and any
reference to a claim nr should be indicated.
10. GLOSSARY
Consult instruction for
use
Suitable for Home care
use
Caution Suitable for Hospital
care use
Ambient pressure limit Keep away from heat and
flammable material
Keep away from oil and
grease SN Serial number
Humidity limit REF Catalogue number
Temperature limit LOT Batch code

Keep dry Fragile, handle with care
Date of manufacture Manufacturer
Use by date Weight of product
Inlet parameter Outlet parameter
P1Inlet pressure range P2Outlet pressure
Take back equipment for
recycling. Do not dispose
into unsorted municipal
waste.
P4
Max outlet pressure
(closing pressure)
QOutlet flow
11. 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 manufac-
ture 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.

MANUFACTURER:
GCE, s.r.o. Tel: [phone]
Zizkova 381 Fax: [phone]
583 01 Chotebor http://www.gcegroup.com
Czech Republic © GCE, s.r.o.

Manufacturer:
GCE, s.r.o.
Žižkova 381, 583 01 Chotěboř, Česká republika
http://www.gcegroup.com
Doc. Nr.: IFU0148 DOI: 2020-08-26; Rev.: 00; TI: A6, CB, V1
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