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Okrem toho boli použité nasledovné symboly, ktoré nie sú
špecifikované medzinárodnými smernicami alebo normami, no sú
všeobecne uznávané:
SYMBOL
POPIS
Univerzálny symbol pre recykláciu
Neoficiálny, ale všeobecne uznávaný symbol
odkazujúci na Európsku smernicu
2011/65/EU
RoHS
TECHNICKÉ ŠPECIFIKÁCIE
VÁKUOVÁ JEDNOTKA
Výkon: 12V 3S1P LiPo 3350 mAh
Prevádzková teplota: 15 ° C - 35 ° C
Skladovacia teplota: -20 ° C - + 30 ° C
Vlhkos (prevádzka / skladovanie): 30% - 70%
Atmosférický tlak (prevádzka / skladovanie): 70,0 - 106,0 kPa
Tolerancia merania: odsávanie ± 10%
Hmotnost: 800 g
Stupen ochrany: Ip44
ZDROJ NAPÁJANIA
Model: Powerbox EXM30 5008
Výkon: 15V
Prevádzková teplota: 0 ° C - 40 ° C
Skladovacia teplota: -40 ° C - + 75 ° C
Maximálny absorbovaný výkon: 30W
Maximálny výstupný prúd: 2,45A
LEGENDA
01 Displej
02 Klávesnica
03 Upevòovacie úchytky
04 Pripojenie filtra / ventilu
05 Pripojenie napájania
06 Konektor pre filter (ak nie je použitý)
07 Napájanie (príslušenstvo)
08 Filter / ventil
09 REDAX hrudný drenážny systém
10 Symbol konektora
11 Symbol stavu nabitia batérie
12 Symbol nabíjania batérie, ked je jednotka vypnutá
13 LED
14 Šípky nahor / nadol
15 Tlacidlo I / O
16 Symbol zámku uzamknutie klávesnice
17 Nastavená hodnota tlaku
18 Symbol NEVYHADZOVA
Dátum vydania poslednej verzie:
Pozri poslednú stranu: (REV .: XX-XXXX)
EN
INSTRUCTIONS FOR USE
INTENDED USE OF THE DEVICE
The Drentech® Mobile REDLINE Thoracic Suction device
(hereinafter referred to as "Vacuum Unit") is a portable unit with
rechargeable batteries capable of generating adjustable suction. It is
intended for use following thoracic surgery where a portable and
independent vacuum unit is required.
DEVICE DESCRIPTION
The vacuum unit is a portable and adjustable suction system
dedicated to use with compatible Redax thoracic drainage systems.
The vacuum unit is composed of a plastic casing housing a user
interface display (1), a keypad (2), a surface with fastening tabs (3) to
secure the vacuum unit to the drainage system, a filter/valve
connection port (4), a power supply connector (5) and a pin (6) to
house the filter/valve pipette when it is not connected to the drainage
system.
ACCESSORIES
The vacuum unit has the following accessories:
•
A power supply (7) that allows recharging the batteries and
continuous operation of the vacuum unit.
•
A filter/valve (8) to allow safe connection to the thoracic drainage
system (9).
The power supply is equipped with adapters for the various
international electrical power supply standards; refer to the relative
user manual for further details.
The vacuum unit may only be used in conjunction with a Redax
single-use thoracic drainage system for which compatibility is
expressly declared.
GENERAL WARNINGS/PRECAUTIONS
- THE VACUUM UNIT IS SUPPLIED NOT STERILE
AND MUST NOT BE SUBJECTED TO ANY
STERILIZATION CYCLE.
- The vacuum unit may only be used with Redax
single-use thoracic drainage systems for which
compatibility is expressly indicated. To this end, see
the relative instructions for use.
- Do not use the vacuum unit if its casing is clearly
damaged.
- Carefully follow the instructions to prepare the
vacuum unit for use before using the system.
- Do not expose the vacuum unit and the accessories
to contact with liquids or atmospheric agents in
conditions such as to exceed the IP44 degree of
protection. For the cleaning operations, refer to the
dedicated section below.
- This device and each of its parts can be used in saf
conditions only in the field of application and
according to the procedures indicated in this
instruction leaflet in correspondence to the type of
product.
The manufacturer declines all
responsibility for improper use or different from
that indicated.
- The device may only be used by qualified and
specialized medical staff (doctors and/or nurses),
only in the field of application and according to the
procedures indicated in this instruction leaflet in
correspondence to the type of product.
manufacturer declines all responsibility for use by
unauthorized persons.
- The vacuum unit contains rechargeable batteries
without memory effect, which can be recycled in all
countries where differentiated waste collection is
required and in any case in accordance with the
local regulations in force.
NOTE :
to appropriately dispose of the batteries,
they have to be removed from the
container. The batteries may only be
replaced/removed by REDAX personnel
or in any case specialized persons
authorized by REDAX.
During operation, do not cover the vacuum unit
-
and/or the battery charger and/or the thoracic
drainage system with clothes, gauze or other
materials in order to prevent overheating.
- The physician responsible and the assistant
personnel must be aware of the possible
complications related to high suction drainage for
proper use of the vacuum unit with values higher than
-30cmH O (-3.0 Kpa) for which they are responsible in
2
the last resort.
- If used at high altitude or on board aircraft, the
performance of the vacuum unit might differ from the
nominal.
- Do not expose the vacuum unit to high temperatures
or fire because there is a risk of the batteries
exploding.
- DO NOT DISCARD THE UNIT TOGETHER WITH THE
BLOOD COLLECTION SYSTEM AFTER USE!
- To avert this eventuality, when the unit is turned off it
flashes for a certain number of times at the same time
emitting an acoustic alarm and showing the
dedicated symbol (18) on the display.
- The unit has passed all the electromagnetic
compatibility and electrical safety tests in compliance
with the applicable European standards (CEI EN
60601-1-2): in any event, it is recommended to pay
attention when the device is used in proximity of
equipment that emits electromagnetic radiation
during use.
PREPARING FOR USE
Preliminary battery charging
The vacuum unit requires charging before it is used for the first time.
1. Take the vacuum unit out of the package.
2. Connect the power supply to the vacuum unit using the socket (5) on
the rear of the unit.
3. Connect the power supply to a mains socket to start charging the
batteries contained in the device.
Warnings for recharging and the batteries
The unit is equipped with rechargeable lithium polymer (LiPo)
batteries. The vacuum unit is shipped with the batteries on low
charge; it is advisable to put the device on charge until the batteries
are fully charged. A complete charge from a completely flat battery
takes about 1.5-2 hours.
4. Charging is indicated by the electric plug symbol (10) that appears
on the display next to the battery charge status symbol (11) when
the unit is on or by the battery symbol with an indication of the
current charge status when the unit is off (12).
NOTE:
The batteries will not be charged if they are damaged
e
or the polarity is inverted or there is a short-circuit. In
this event, a warning light will come on as described in
the section "Warning lights and acoustic alarms".
Preparing the vacuum unit
Operate as follows to prepare the vacuum unit for use:
1. Prepare the Redax thoracic drainage system for use following the
relative instructions for use and connect it to the drainage catheter.
2. Assemble the filter/valve unit (8) to the vacuum unit and connect the
unit to the drainage system as shown in Figure 1. To this end, slide
the drainage system on the upper surface of the vacuum unit taking
care to fit the side and rear fastening tabs of the drainage system
into place in the tabs on the vacuum unit.
USING THE DEVICE
The
Using the vacuum unit
Turn on the vacuum unit using the I/O button (15).
When the unit is turned on, it runs a functional test of the circuit with a
solenoid valve excitation cycle (you should hear the valve opening and
closing click) and pump activation for a few seconds. Should you not
hear the solenoid valve opening and closing click and/or the noise of
the running pump, the unit might be damaged. In this case, contact
Redax Technical Service.
The battery charge (11), the suction value (17) and the suction unit of
measure will be shown on the vacuum unit display. When the unit is
turned on, it will be adjusted to "0 cmH O", i.e. it will not perform any
2
suction until the physician selects the desired negativity value. The unit
is set to show the data in cmH O; to show the data in kPa, contact
2
Redax Technical Service.
Select the desired suction value by acting on the Arrow Up/Arrow Down
buttons (14).
At this point, the vacuum unit will start operating intermittently, the
frequency of activation depending on the amount of patient air and/or
fluid leakage. You can change the suction value at any time by acting
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