GCE MEDIEVAC+ Manual de usuario
MEDIEVAC+
INSTRUCTION FOR USE
NÁVOD K POUŽITÍ
HASZNÁLATI ÚTMUTATÓ
INSTRUKCJA OBSŁUGI
INSTRUCCIONES DE USO
INSTRUÇÃO DE UTILIZAÇÃO
NOTICE D´INSTRUCTIONS
BETRIEBSANLEITUNG
ISTRUZIONI D‘USO
NAPUTAK ZA UPORABU
ΟΔΗΓΙΕΣ ΧΡΗΣΕΩΣ
NAVODILA ZA UPORABO
INSTRUCȚIUNI DE UTILIZARE
GCE HEALTHCARE
EN
CS
HU
PL
ES
PT
VACUUM REGULATORS
PODTLAKOVÉ REGULÁTORY
VÁKUUMSZABÁLYOZÓK
REDUKTOR PRÓŻNI
REGULADOR DE VACIO
REGULADORES DE VÁCUO
RÉGULATEUR DE VIDE
VAKUUMREGLER
REGOLATORE DEL VUOTO
REGULATORI PODTLAKA
ΡΥΘΜΙΣΤΕΣ ΚΕΝΟΥ
PODTLAČNI REGLULATORJI
REGULATOARE DE VACUUM
FR
DE
IT
HR
EL
SL
RO
Fig. 1
A
E
D
C
B
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EN
1. FOREWORD
GCE Vacuum regulators are medical devices classified as class IIa
according to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC
Medical Device Directive is based upon EN ISO 10079-3 standard.
2. INTENDED USE
MediEvac+ is a variable control medical suction equipment powered from
a vacuum source used for vacuum regulation.
MediEvac+ is intended for suction of blood and body liquids from any parts
of patient´s body mainly during surgical operations, resuscitation, chesty
and gastritic drainage, etc.
The product is not intended to be powered from:
• a venturi vacuum source
• a pressure gas source.
The product is not intended for:
• field use
• direct(*) use during thoracic drainage
The“250mbar” variant is not intended to be used for Pharyngeal suction.
(*) For thoracic drainage therapy, MediEvac+ can be used as a first stage
vacuum source setting device to power a thoracic drainage system.
In this case, the user must ensure that the complete system
(MediEvac+ & Thoracic drainage system) meets the requirement of ISO
10079-3 appropriate sections
Read this instruction before use of the product. Always follow this
instruction!
The product shall only be used for the purpose described in this
instruction!
The product must be installed and used by a qualified person and by
compliance of all requirements of standards EN ISO 10079-3 as amended!
Before use, to guarantee the safety of the patient, check the equipment
and the accessories used with the product, so that data and performance
comply with the intended use of the product!
The product must not, under any circumstances be modified by other
than the manufacturer!
ENGLISH
INSTRUCTION FOR USE: MEDIEVAC+
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3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep the product and its associated equipment away from:
• All sources of heat,
• Flammable materials,
• Oil or grease (including all hand creams),
• Water,
• Dust.
The product and its associated equipment must be prevented from
tipping over and falling.
Always maintain oxygen cleanliness standards.
Use only the product and its associated equipment in a well ventilated
area.
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 prevention
and environmental protection must be observed.
National laws, rules and regulations for vacuum accident prevention and
environmental protection must be observed.
OPERATING CONDITIONS STORAGE AND TRANSPORT
CONDITIONS
-10/+40 °C -20/+60 °C
10/70 % 10/100 %
950/1100 mbar 600/1200 mbar
4. PERSONNEL INSTRUCTIONS
The Medical Devices Directive 93/42/EEC states that product provider
must ensure that all personnel handling the product are provided with the
operating instructions & performance data.
Do not use the product without properly familiarization of the product
and its safe operation as defined in this Instruction for use. Ensure user
is aware of particular information and knowledge required for the gas
in use.
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5. PRODUCT DESCRIPTION
MediEvac+ vacuum regulator range includes 3 variants:
• MediEvac+ 250: for a vacuum level from 0 to 250 mbar*
(maximum regulator vacuum level)
**Maximum suction flow - 55l/min +-5l/min at -250mbar
• MediEvac+ 600: for a vacuum level from 0 to 600 mbar*
(maximum regulator vacuum level)
**Maximum suction flow - 65l/min +-5l/min at -600mbar
• MediEvac+ 1000:for a vacuum level from 0 to 1000 mbar*
(maximum regulator vacuum level)
**Maximum suction flow - 65l/min +-5l/min at -950mbar
It mainly consists of an outlet quick connector (vacuum source side),
a push-pull on/o valve, control handwheel, a vacuum indicator and a
threaded inlet (patient side).
MediEvac+ 250 variant is fitted with a negative pressure protection to limit
the vacuum level in case single fault condition.
The pressure relief valve opens at a vacuum - 270 mbar.
The full flow at - 290 mbar.
Refer to appendix Nr 1 to see features available on your product.
According to EN ISO 10079-3 it is a device with Medium vacuum.
(Level of vacuum between 20kPa and 60kPa below atmospheric pressure).
* Note that if the medical pipeline vacuum source depression level
is below the MediEvac+ maximum vacuum level, then the maximum
attainable vacuum level is vacuum source depression level and not the
MediEvac+ maximum vacuum level.
** Note that the values apply to device without connected accessories.
At conditions 20°C;1013hPa
Note: The achievable vacuum depends on atmospheric pressure. Every
100m increase in altitude causes a decrease in the achievable vacuum of
about 1.4 kPa.
A. Outlet Quick Connector (medical pipeline vacuum
source Side)
The product is fitted to the medical gas pipeline vacuum source (terminal
unit) by a vacuum type male probe.
Refer to appendix Nr 1 for quick coupler type and appendix Nr 2 to get
information about connection and release method.
B. Push-pull on/o Valve
MediEvac+ is equipped with a push-pull on/o valve on the side of the
product, to shut o the vacuum source.
The vacuum regulator is ON when the red push-pull valve button has been
pushed on (only the green button shall be visible from the front side of the
vacuum regulator.
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The vacuum regulator is OFF when the green push-pull valve button has
been pushed on (only the red button shall be visible from the front side of
the vacuum regulator.
C. Vacuum level control knob
The front control knob allows the user to set the vacuum level at patient
side from 0 to the maximum regulator vacuum level.
Vacuum level at patient side increases by turning the vacuum level control
knob anti-clockwise.
Vacuum level at patient side decreases by turning the vacuum level control
knob clockwise.
D. Threaded inlet (patient side)
The vacuum regulator inlet (patient side) is G ½“ type allowing the
connection of vacuum regulator associated equipment. Refer to appendix
Nr 1 for inlet connection type.
E. Vacuum level indicator
MediEvac+ variants are fitted with a vacuum level indicator, measuring the
vacuum level at suction unit patient side.
6. OPERATIONS
6.1. CONNECTION & USE OF INLET PATIENT SIDE
MediEvac+ is used with the optional associated equipment specified in
Chapter 8.
6.1.1. List of recognised associated equipment
Key Equipment type
(1) Vacuum regulator
(2) Safety container (small collection container*)
(3) Filter
(4) Suction hose
(5) Collection container
(1) (2) (3) (4) (5) (4)
Schematic drawing of typical optional suction associated equipments
sequence
max 0,3 m max 1,5 m
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*In some markets, it is recommended to use a safety container installed
between the vacuum source and the collection container before
the ejector.
Note: The user shall ensure that an overfill protection device is provided
in the associated equipment sequence, so that it prevents fluid entering
the intermediate tubing.
• Safety container (2): Use Safety container (Collection container) with the
required connection.
• Filter (3): Use a filter with the required connection.
• Suction hose (4): Use suction hoses with an inner diameter of 6mm.
(Silicone material)
• Collection container (5): Use the collection container with the required
connection.
• To order above mentioned recognized optional equipment please
contact GCE.
The installation must conform to the standard EN ISO 10079-3 as
amended.
MediEvac+ shall be used with one or more collection containers during
suction operations. Refer to section 6.1“Connection & use of inlet (patient
side)” to select the appropriate security and collection container type.
Air leaving the collection container should pass through a filter before
entering the suction equipment. Refer to section 6.1“Connection & use of
inlet (patient side)” to select the appropriate filter type.
Before connecting any accessory or medical device to the ejector, always
check that they are fully compatible with the MediEvac+ features &
performances.
Before connecting any accessory to the product make sure that the
integrated handwheel is in the OFF position and that the patient is not
connected.
Before connecting any accessory or medical device to the regulator,
always check that they are fully compatible with the MediEvac+ features
& performances (see details of vacuum, flow & user connections in
appendix nr 1 & 2) and they are produced in accordance with directive
MDD 93/42/EEC and valid standard EN ISO 10079-3.
Before connecting any accessory to the product make sure that the push-
pull on/o valve is on o position and that the patient is not connected.
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6.2. BEFORE USE
6.2.1. Visual Inspection before fitting
• Check if there is visible external damage on the vacuum regulator and
its associated equipments (including product labels and marking). If it
shows sign of external damage, remove the products from service and
identify its status.
• Visually check if the regulator and its associated equipments are
contaminated; if needed, apply the cleaning procedure according to
cleaning procedure here under.
• Check if the service or the disposal time has not been exceeded, using
GCE or owner’s date coding system. If service or disposal time has been
exceeded, remove the product from service & suitably identify its status.
6.2.2. Fitting to medical vacuum pipeline system terminal units
Refer to appendix Nr 1 to get information about quick coupler type on your
product.
Refer to appendix Nr 2 to get information about connecting / disconnecting
procedure.
For regulator fitted with a rail clip and a flexible hose, clip the vacuum
regulator on the rail prior to connect the quick coupler.
6.2.3. Fitting of the safety container
• Turn the container top nut clockwise to connect it to the regulator (do
not apply an excessive torque).
6.2.4. Functional test before use and Leakage test
• After connection to medical pipeline system terminal unit and its
associated equipment, set the vacuum level control knob in mid position.
• Set the vacuum regulator ON by pushing the red button.
• Check that there is a significant vacuum level at patient side inlet by
locking the patient side inlet with your finger.
• Set the vacuum regulator OFF by pushing the green button and check
if vacuum level is without change at locked patient side inlet by your
finger.
• Set vacuum level control knob at minimum vacuum position by turning
it clockwise.
If any leakage is detected, check connections and repeat leakage test.
If any leakage is detected again, apply the“After use” procedure below
and return the valve to GCE for service or repair.
6.3. OPERATIONS
• Set the vacuum regulator ON by pushing the red button.
• Lock the patient side inlet with your finger.
• Set the vacuum level to the needed level for your therapy by turning the
vacuum level in the anti-clockwise direction and checking the vacuum
indicator.
• The vacuum regulator is ready to be used.
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6.4. AFTER USE
• Before disconnecting regulator from the medical pipe line system
terminal unit:
−Turn it O, by pushing the green button and set vacuum level control
knob at minimum vacuum position by turning it clockwise.
−Remove suction tubing connection from patient side.
−Visually check if the safety container and the filter are contaminated;
if so disconnect it and clean/replace according to section 8.
Refer to appendix Nr 2 to get information about connecting / disconnecting
procedure (For regulator fitted with a rail clip and a flexible hose, disconnect
the quick coupler prior to un-clip the vacuum regulator on the rail).
7. ACCESSORIES
Not available.
For closer information about the possible optional equipment refer to the
section 8.2 associated equipment.
8. CLEANING
8.1. VACUUM REGULATOR
If there is risk that MediEvac+ is exposed to contamination following
cleaning shall be used:
Remove general contamination with a soft cloth damped in oil free oxygen
compatible soap water and clean with deionised water.
Disinfection can be done with an alcohol-based preparation (moistened
wipe). If another cleaning agent is used, check that it is not abrasive and is
compatible with the product materials (including labels) and gas (a suitable
cleaning agent - e.g. Meliseptol).
Do not immerse the product in any liquid.
Do not expose to high temperature (such as autoclave).
Do not use cleaning solutions contains ammonia.
8.2. ASSOCIATED EQUIPMENTS
The used associated equipment shall comply with EN ISO 10079-3
as amended and with appropriate Instruction for use:
• Filter: Use a filter with the required connection.
• Suction hose: Use suction hoses with an inner diameter of 6mm.
• Collection container: Use the collection container with the required
connection.
• Safety container: Use safety containers with the required connection.
Before connecting any associated equipment or medical device to the
MediEvac +, always check that they are fully compatible with connection
features & performances of the product.
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9. LIFETIME, MAINTENANCE AND SERVICE
9.1. LIFE TIME
9.1.1. Serial number and date of production
Serial number composition is the following: YY MM XXXXX
Y: 2 last numbers of the year
M: month
X: production number
MediEvac+ serial number is placed on plastic body of valve.
The perforated space on the product label indicates the year when the
equipment has to be disposed o.
9.1.2. Life time and waste management
Maximum life time of the product is 10 years. At the end of the product’s
life time(10 years maximum), the product must be withdrawn from service.
To prevent reuse, the owner shall make the product impossible to use, or
contact GCE for return of product.
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 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 ecient 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. SERVICE, REPAIRS AND MAINTENANCE
9.2.1. Service
GCE recommends that a product periodic inspection is undertaken at least
once a year to do leakage test and check proper functionality of the
MediEvac+. Service must be carried just by GCE authorized service.
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