EKOM DK50 DI Používateľská príručka

Typ
Používateľská príručka
User manual
EN
Manuel de l’utilisateur
FR
Návod na použitie
SK
Руководство пользователя
RU
Návod k použití
CS
MEDICAL COMPRESSOR
COMPRESSEUR MÉDICAL
МЕДИЦИНСКИЙ КОМПРЕССОР
MEDICINÁLNY KOMPRESOR
MEDICINÁLNÍ KOMPRESOR
DK50 DI
EKOM spol. s r. o.
Priemyselná 5031/18
SK-921 01 Piešťany
Slovak Republic
tel.: +421 33 7967255
fax: +421 33 7967223
www.ekom.sk
email: ekom@ekom.sk
DATE OF LAST REVISION
DATE DE LA DERNIERE REVISION
ДАТА ПОСЛЕДНЕГО ПЕРЕСМОТРА
DÁTUM POSLEDNEJ REVÍZIE
DATUM POSLEDNÍ REVIZE
11/2023
NP-DK50 DI-19_11-2023
112000234-000
CONTENTS
4 NP-DK50 DI-19_11-2023
CONTENTS
1. GENERAL INFORMATION ................................................................................................................. 5
INTENDED USE ............................................................................................................................. 5
CONTRAINDICATIONS AND SIDE-EFFECTS ............................................................................. 5
OPERATOR'S RESPONSIBILITY FOR PATIENT SAFETY ......................................................... 5
MARKINGS .................................................................................................................................... 5
WARNINGS .................................................................................................................................... 5
General safety warnings ...................................................................................................... 6
Electrical system safety warnings ....................................................................................... 6
WARNING NOTICES AND SYMBOLS .......................................................................................... 7
USE ................................................................................................................................................ 8
STORAGE AND TRANSPORT ...................................................................................................... 8
2. EQUIPMENT DESCRIPTION .............................................................................................................. 9
DISPLAY UNIT ............................................................................................................................. 10
FEATURES .................................................................................................................................. 11
FUNCTION ................................................................................................................................... 12
3. TECHNICAL DATA ............................................................................................................................ 13
Variants .............................................................................................................................. 14
4. OPERATION ...................................................................................................................................... 15
INSTALLATION AND FIRST OPERATION ................................................................................. 15
Unlocking of air pump ........................................................................................................ 16
Installation of couplings for connecting hoses .................................................................. 17
Compressed air connection ............................................................................................... 17
Electrical connection.......................................................................................................... 18
First operation .................................................................................................................... 18
OPERATION ................................................................................................................................ 18
Switching the compressor on ............................................................................................ 18
Running the compressor ................................................................................................... 19
Alarm system ..................................................................................................................... 19
Cleaning and replacing the air inlet filter ........................................................................... 20
Cleaning the compressor .................................................................................................. 20
5. MAINTENANCE ................................................................................................................................. 21
REPAIRS AND SERVICE ............................................................................................................ 21
MAINTENANCE SCHEDULE ...................................................................................................... 21
Replacing of battery ........................................................................................................... 22
Safety valve check ............................................................................................................. 22
Check tightness of joints and inspect the equipment ........................................................ 23
Replacing the suction filter ................................................................................................ 23
Replacing of air filter cartridge ........................................................................................... 23
Replacing of fuses ............................................................................................................. 23
Replacing of power supply cord ........................................................................................ 24
Maintenance materials ...................................................................................................... 24
SHUT-DOWN ............................................................................................................................... 24
EQUIPMENT DISPOSAL ............................................................................................................. 25
BATTERY DISPOSAL .................................................................................................................. 25
6. TROUBLESHOOTING ....................................................................................................................... 26
7. ELECTRIC AND PNEUMATIC DIAGRAMS ..................................................................................... 27
WIRING DIAGRAM ...................................................................................................................... 27
PNEUMATIC DIAGRAM .............................................................................................................. 28
8. ELECTROMAGNETIC COMPATIBILITY DECLARATION .............................................................. 29
9. ANNEX ............................................................................................................................................. 146
INSTALLATION RECORD ......................................................................................................... 146
GENERAL INFORMATION
NP-DK50 DI-19_11-2023 5
1. GENERAL INFORMATION
INTENDED USE
The DK50 DI medical air compressor is indicated for supplying compressed
air for medical ventilators.
CONTRAINDICATIONS AND SIDE-EFFECTS
There are no contraindications or side-effects known.
OPERATOR'S RESPONSIBILITY FOR PATIENT SAFETY
This manual is an integral part of the equipment and must be kept with the
compressor. Careful review of this manual will provide information necessary
for correct operation of the equipment.
Rx only
USA Federal law restricts this device to sale by or on the order of a
physician.
MARKINGS
Products marked with the TÜV Rheinland C US certification mark comply
with all regulations in the United States of America and Canada.
Products marked with the CE mark of compliance meet the safety
requirements of the European Union (93/42/EEC).
WARNINGS
The safety of operating personnel and trouble-free operation of the
equipment are ensured only if original parts are used. Only accessories
and spare parts mentioned in the technical documentation or expressly
approved by the manufacturer can be used.
If any other accessories or consumable materials are used, the
manufacturer cannot be held responsible for the safe operation and
functionality of the equipment.
The warranty does not cover damages resulting from the use of
accessories or consumable materials other than those recommended by
the manufacturer.
The manufacturer assumes responsibility for the safety, reliability and
function of the equipment only if:
- Installation, calibration, amendments, extensions and repairs are
performed by the manufacturer, one of its representatives or a service
provider authorized by the manufacturer
GENERAL INFORMATION
6 NP-DK50 DI-19_11-2023
- The equipment is used in accordance with this manual.
This manual accurately describes the design of the compressor and its
compliance with safety and technical standards. The manufacturer
reserves all rights to its wiring diagrams, procedures and names.
This user manual is the original instructions. Translation is performed in
accordance with the best available knowledge.
General safety warnings
The equipment is designed to operate safely when used correctly. Please
note the following safety measures to avoid injury or damage.
Equipment operation must comply with all local codes and regulations.
Original packaging should be kept for the possible return of the unit. Only
original packaging ensures optimal protection of the equipment during
transport. If it is necessary to return the equipment during the warranty
period, the manufacturer is not liable for damages caused by incorrect
packaging.
The user must immediately notify the supplier if any problem occurs during
the use of the equipment.
This product is not intended for use in areas where there is a risk of an
explosion. Do not operate the compressor in the presence of flammable
anaesthetics.
Never feed oxygen or nitrous oxide into the compressor. Compressor
components are not approved for oxygen or nitrous oxide use.
The compressor must not be used for supplying air to the medical air
central distribution pipeline system.
Electrical system safety warnings
To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
Before the compressor is plugged in, make sure that the voltage and
frequency of the mains specified on the equipment are the same as the
power mains.
Before operating, check for possible damage to the equipment and any
connections. Damaged pneumatic and electrical lines must be replaced
immediately.
If a technical failure occurs, immediately disconnect the equipment from
the mains (pull out the main power plug).
During repairs and maintenance, ensure that:
- The main power plug is removed from the power socket
- Compressed air lines are disconnected
- All pressure has been released from the air tank
Only a qualified technician can install this equipment.
GENERAL INFORMATION
NP-DK50 DI-19_11-2023 7
WARNING NOTICES AND SYMBOLS
The following symbols are used for important information in this manual and
on packaging and the product:
General warning
Caution, risk of electric shock
Refer to instruction manual
Certification mark for the EU
Medical device
Serial number
Article number
Unique Device Identifier
Swiss Authorised Representative
Swiss Importer
Compressor is controlled automatically and may start
without warning
Caution, hot surface
Handling mark on package FRAGILE
Handling mark on package THIS SIDE UP
Handling mark on package KEEP DRY
Handling mark on package TEMPERATURE
LIMITATIONS
Handling mark on package LIMITED STACKING
Mark on package RECYCLABLE MATERIAL
Ground connection
Fuse
GENERAL INFORMATION
8 NP-DK50 DI-19_11-2023
Never dispose of the battery with common household
waste
Manufacturer
IP21
Device is protected against touch by fingers and water
condensation
USE
The equipment can be installed and operated only in a dry, ventilated and
dust-free area. Climatic conditions for operation - see Technical data.
The compressor must stand on a flat and stable base.
The compressor must not be exposed to rain. The equipment must not be
used in humid or wet environments. Never use the compressor in the
presence of flammable liquids or gases.
Before connecting the compressor to respiration equipment, make sure
that it meets the requirements of the respiration equipment. Refer to the
Technical data for this purpose.
Any use other than the compressor‘s intended use is not considered to be
safe. The manufacturer is not responsible for any damages that result if
the compressor is used for any other purpose. Risk is exclusively
assumed by the operator/user.
STORAGE AND TRANSPORT
The compressor is shipped from the factory in transport packaging with the
pump stabilized, protecting it from damage during transport.
For transport, always use the original packaging and secure the compressor
in the upright position.
Protect the compressor from humidity, contamination and extreme
temperatures during transport and storage. A compressor in its original
packaging should be stored in a warm, dry and dust-free area.
Keep the packaging material, if possible. If not, dispose of the packaging
material in an environmentally-friendly way. Cardboard can be recycled.
Before moving or transporting the compressor, the pressure in the air tank
and hoses must be released.
Slowly vent air from the compressor by screwing the provided nipple (it may
be an integral part of the outlet house) into the OUT connector (7) and
waiting until all air has been vented.
Warning! Wear eye protection when venting the air!
Prior to transport it is necessary to secure the motor inside the
compressor (Chapter 4.)
EQUIPMENT DESCRIPTION
NP-DK50 DI-19_11-2023 9
2. EQUIPMENT DESCRIPTION
1. Display unit
2. Fused power cord connector
3. Power switch
4. USB port
5. Inlet filter
6. Air inlet from the external source
7. Air outlet
8. Ethernet port
9. Total operating hours
10. Output pressure
11. Pressure units bar / psi
12. Internal temperature
13. Signal indicator
14. Signal / service description
(low pressure, high pressure,
mains, temperature, service)
15. Pressure indicator
16. Loss of power
17. Battery indicator
18. Power / standby indicator
EQUIPMENT DESCRIPTION
10 NP-DK50 DI-19_11-2023
DISPLAY UNIT
NORMAL DISPLAY
Output pressure indicator
During normal operation the pressure displayed on the
graphical bar occur between the pressure limits,
symbols below the graphical bar.
Default pressure units are BAR. Change of units to PSI
is available. To change settings contact your service
representative.
Total operating hours indicator
Power / standby indicator
In run mode, the symbol permanently displayed.
In stand-by mode, the symbol flashed.
VISUAL ALARM SIGNALS
Low pressure
Signal is active, until the pressure is below the low
pressure limit.
Default value is 1,7 bar. Change of value is available.
To change settings contact your service representative.
High pressure
Signal is active, until the pressure is above the high
pressure limit.
Default value is 5,0 bar. Change of value is available.
To change settings contact your service representative.
High temperature
Signal is active if internal temperature rise above
65°C.
Loss of power
The signal is activated after a power loss. The device
automatically turns off after 5 minutes signal duration.
EQUIPMENT DESCRIPTION
NP-DK50 DI-19_11-2023 11
SERVICE INDICATIONS
Indication of on-coming periodic maintenance
Message is permanently displayed. Digit indicates
how many hours remain to the prescribed service
action. To ensure preventive maintenance contact
your service representative in time.
Indication of necessity realize periodic
maintenance
Message flashed. It is necessary to perform periodic
maintenance. Contact your service representative.
Battery indicator
If the symbol is displayed, the battery needs replacing.
Contact your service representative.
FEATURES
AUTO OFF Switching to standby
sufficient pressure in the central air distribution
(default more than 2,8 bar)
AUTO ON Switching to run
insufficient pressure in the central air distribution
(default less than 2,5 bar)
POWER SAVE Switching to standby
air consumption is for some time very low or null
FULL OFF Shutdown
after 5 minutes without power supply
EQUIPMENT DESCRIPTION
12 NP-DK50 DI-19_11-2023
FUNCTION
Description
The DK50 DI medical compressor is a portable air compressor designed to
supply air to medical ventilators. Optional equipment is stand. Assembly
compressor with stand is a mobile device. Integrated oil-free piston pump
continuously compresses air, which is then cooled, filtered and dried. The
compressed air is fed into an internal tank with a defined pressure range.
Backup compressed air source
The equipment is connected to the central air distribution line of hospital and
medical ventilator is connected to the outlet air connector of device.
Compressed air in the central distribution line is measured by the pressure
sensor. The compressor remains in STANDBY mode when the pressure
level is sufficient. If the pressure drops, the controller automatically starts up
the compressor.
Primary compressed air source
The compressor continuously supplies compressed air for use with the
medical ventilator if not connected to a central compressed air line.
Warning:
The user is obliged to secure a suitable backup compressed air source
if compressed air deliveries from the compressor are interrupted. The
manufacturer cannot assume any liability for any damages that occur in
connection with an interruption of compressed air deliveries to a
patient.
TECHNICAL DATA
NP-DK50 DI-19_11-2023 13
3. TECHNICAL DATA
DK50 DI
430700A19-100
430700B19-100
430700019-100
V
Hz
A
100
50 / 60
7.1
120
60
6.0
230
50 / 60
2.8
55 LPM
3 bar / 43.5 psi
55 LPM
3.5 bar / 50.8 psi
-
40 LPM
4.0 bar / 58 psi
Peak flow without pressure drop
below1.7 bar (25 psi)
Outlet connection
DISS 1160-A (3/4"-16 UNF)
optional NIST (EN 739)
m
0.01
˃10 °C
dB(A)
˂ 48
Operating mode
Continuous - S1
Draining of condensate water
Maintenance-free
2.5 bar / 36.3 psi
2.8 bar / 40.6 psi
Low pressure alarm
1.7 bar / 24.7 psi
High pressure alarm
5.0 bar / 72.5 psi
High temperature alarm
65 °C / 149 °F
Power failure alarm
yes
Auditory alarm signal - acoustic pressure dB(A)
≥57** / ≥60
yes
hrs
5,000
L
2
W x L x H
425 x 305 x 580 mm / 16.73 x 12.0 x 22.83 in
570 x 560 x 1040 mm / 22.44 x 22.05 x 40.94 in
30 kg / 66 lbs
Configuration pursuant to IEC 60601-1:2005,
ANSI/AAMI ES60601-1:2005,
CAN/CSA 22.2 No. 60601-1:2008
Class I.
Classification pursuant to MDD 93/42 EEC,
2007/47 EC
II b
*) Consult factory
**) valid for power failure alarm
TECHNICAL DATA
14 NP-DK50 DI-19_11-2023
Climatic conditions for storage and transport
Temperature –25°C to +55°C (-13°F to +131°F), 24 hrs +70°C (+158°F)
Relative air humidity 0% to 100% (with condensation)
Climatic conditions for operation
Temperature +10°C to +40°C (+50°F to +104°F)
Atmosferic pressure 680 hPa to 1080 hPa
Relative air humidity 0% to +95%
IP21 Rating
Output flow correction for differences in elevation
Output flow correction table
Elevation [mamsl]
0 - 1500
1501 - 2500
2501 - 3500
Output flow [l/min]
FAD x 1
FAD x 0.8
FAD x 0.71
FAD efficiency refers to conditions at an elevation of 0 mamsl:
Temperature: 20°C
Atmospheric pressure: 1013 hPa
Relative humidity: 0%
Variants
Compressors DK50 DI are designed in the following variants:
Compressor on rubber
feet
Compressor on a mobile
chassis
Compressor on a mobile
chassis with a stan
OPERATION
NP-DK50 DI-19_11-2023 15
4. OPERATION
INSTALLATION AND FIRST OPERATION
Do not use the compressor immediately after unpacking as it will not
adjust to the ambient temperature.
Only qualified personnel can install the compressor and put it into
operation for the first time. The installer shall train the operating
personnel in the use and routine maintenance of the equipment.
Installation and training of personnel should be acknowledged by the
installer‘s signature on the installation certificate.
Prior to start-up must be unsecuring the air pump inside. If the
compressor is switched on with securing the air pump, the device
could be permanently damaged.
The compressor does not contain a backup power supply.
Never block the air intake filter on the backside or the vent outlets on
the lower of the equipment.
If the compressor is equipped with a main source of air, the standby air
source must be available.
Any modification of this equipment is forbidden!
If this equipment is used nearby other devices, the equipment must be
observed in order to verify normal operations in the configuration it will
be used.
Devices may be affected electro-magnetically!
You may notice a “new product” odour when you first place the
product into service (for a short period of time). This odour is
temporary and does not impede the normal use of the product. Ensure
the space is properly ventilated after installation.
OPERATION
16 NP-DK50 DI-19_11-2023
Unlocking of air pump
Before the first use it is necessary unlock the air pump inside to the
normal position.
Unpack the device and place it on a flat floor.
Transport position
Air pump inside is locked, two red screws protruding out.
Normal position
Before use it is necessary unlock the air pump inside. Screw both screws
inward using included wrench Nr. 5.
Before the later transport of device, it is necessary lock the air pump to
the transport position.
OPERATION
NP-DK50 DI-19_11-2023 17
Installation of couplings for connecting hoses
Use a box wrench to install the couplings supplied with the product into the
openings in the rear panel. Beware of possible confusion - the marking on
the coupling must match the marking on the product. Use the supplied plastic
sealing rings to seal the connection.
Compressed air connection
Air inlet (WALL)
Connect the compressed air line from the central distribution line to the
WALL quick coupling - inlet compressed air (if a central air distribution line is
available).
Air outlet (OUT)
Connect the pressure hose to the medical ventilator to the OUT quick
coupling on the compressed air outlet.
Air from the central distribution system is automatically connected through
the compressor to the OUT outlet port. In this configuration, the compressor
serves as a backup source of compressed air. If the air pressure from the
central distribution system is reduced, the compressor automatically switches
on and there is no interruption in the supply of continuously pressurized air at
the outlet of the compressor.
The maximum rated air pressure for the WALL quick coupling is 5.5 bar
/ 80 psi. Please note that the air supply from the central distribution line
entering the compressor must be medical grade air (particulate size
and moisture content). The compressor does not modify the air from
the central distribution line.
OPERATION
18 NP-DK50 DI-19_11-2023
The hose connecting the compressor to medical ventilator must not
pass through a cold environment i.e. placed on the ground. It should be
as short as possible with no kinks (this may cause water to condense
inside the hose).
The compressor must not be used for supplying air to the medical air
central distribution pipeline system.
Electrical connection
The compressor comes with a plug containing an appropriate
protective contact (ground) adhere to local electrical regulations. The
voltage and frequency of the mains must comply with the
specifications on the data label.
The electrical cord must not be stressed or have any tension exerted
upon it, and must always be free.
The socket must be accessible for safety reasons so that the equipment
can be safely disconnected from the power supply in case of an
emergency.
The relevant current circuit must be protected.
First operation
Make sure that the pump inside of device was unsecured.
Check that the connection to the compressed air supply is correct.
Check for proper connection to the main power supply. Before the
equipment is plugged in, make sure that the voltage and frequency shown
on the equipment are the same as provided by the power connection.
Switch on the pressure switch to position “I”.
OPERATION
The equipment may only be operated by the trained staff!
In case of emergency, switch the equipment off at the switch and pull
out the main power plug.
Switching the compressor on
The compressor is switched on at the main power switch by putting it in
position "I". The compressor operates in one of the following modes
depending on the pressure in the central distribution line and on the
consumption of compressed air:
OPERATION
NP-DK50 DI-19_11-2023 19
STANDBY / indicator flashing - when pressure in the central compressed air
line is sufficient and the power switch is on, the compressor is in standby
mode. The equipment functions as a backup compressed air source,
monitoring the pressure in the central compressed air line, with the
compressor coming online if the pressure drops to a pre-set level.
RUN / indicator permanently displayed - the compressor operates at low
pressure in the central compressed air line or if the equipment is not
connected to a central compressed air line.
Running the compressor
The display shows the value of outlet pressure in BAR or PSI units. Change
of units is available, contact your service representative.
Total operating hours indicator displaying total operating hours. For
preventive maintenance hours see chapter Maintenance.
Alarm system
All alarm states of the equipment are states of the middle priority technical
alarm according to EN 60601-1-8. Each alarm state is indicated by the
corresponding visual and auditory signal (see Chapter 2 - Display Unit and
Chapter 3 - Technical Data).
Alarm states indicate a potential failure of the device. Therefore, it is not
possible to deactivate the alarm signals.
All alarm signals are non-latching after the triggering event no longer exists
the alarm signals stop.
Operator’s position. No specific operator’s position is required. However, the
operator should remain in the range of visual or audible alarm signal, which
may depend on the actual operating conditions.
Low pressure. The signal is active when the equipment is started up until
the compressor reaches the low pressure limit. The signal may be activated
during operations due to a lack of seal in the compressed air section past the
compressor, increased air consumption or an equipment fault. The visual
indication flashes and the buzzer signal is activated.
Call on an authorized maintenance service provider in the event of a fault.
High pressure. In the case of pressure rise above the high pressure limit
indication flashes and the buzzer signal is activated. The air pump will be
turned off until the pressure drops.
High temperature . If the temperature rise above 65°C indication flashes
and the buzzer signal is activated. Check if the cooling of compressor is not
restricted or ambient temperature is not too high.
Loss of power. In the case of loss of power symbol flashes and the buzzer
signal is activated. Check the electricity supply. After 5 minutes, the signal is
turned off.
OPERATION
20 NP-DK50 DI-19_11-2023
Operators must quickly secure a backup air source for the patient in the
event any of these signals activate during equipment operation.
Test of the alarm system functionality is performed automatically when
the equipment is switched on by a short testing activation of the visual
and auditory alarm signals (light up of LED indicator and auditory
pulse).
Cleaning and replacing the air inlet filter
At least once a week take out and clean the inlet filter (5) located on the back
side. Wash the filter in warm soapy water, rinse thoroughly and allow it to
dry. Insert the clean filters so that the intake openings are completely
covered by the filters.
Cleaning the compressor
To clean the compressor, use a detergent that contains no abrasives,
chemical solvents or other corrosive agents.
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