EKOM DK50 DE Používateľská príručka

Typ
Používateľská príručka
User manual
EN
Руководство пользователя
RU
Benutzerhandbuch
DE
Návod na použitie
SK
N
DK50 DE
MEDICAL COMPRESSOR
MEDIZINALKOMPRESSORМЕДИ
МЕДИЦИНСКИЙ КОМПРЕССОР
MEDICINÁLNY KOMPRESOR
DK50 DE
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
DATE OF LAST REVISION
DATUM DER LETZTEN ÜBERARBEITUNG
ДАТА ПОСЛЕДНЕГО ПЕРЕСМОТРА
DÁTUM POSLEDNEJ REVÍZIE 09/2023
NP-DK50 DE-LF-16_09-2023
112000082-000
CONTENTS
2 NP-DK50 DE-LF-16_09-2023
CONTENTS
1. GENERAL INFORMATION ........................................................................................... 3
INTENDED USE ....................................................................................................... 3
CONTRAINDICATIONS AND SIDE-EFFECTS ........................................................ 3
OPERATOR'S RESPONSIBILITY FOR PATIENT SAFETY ..................................... 3
MARKINGS ............................................................................................................... 3
WARNINGS .............................................................................................................. 3
General safety warnings .................................................................................. 4
Electrical system safety warnings .................................................................... 4
WARNING NOTICES AND SYMBOLS ..................................................................... 5
USE .......................................................................................................................... 6
STORAGE AND TRANSPORT ................................................................................. 6
2. EQUIPMENT DESCRIPTION ........................................................................................ 7
3. TECHNICAL DATA ....................................................................................................... 9
4. OPERATION ............................................................................................................... 10
INSTALLATION AND FIRST OPERATION ............................................................ 10
Removal of transport stabilizers .................................................................... 11
Compressed air connection ........................................................................... 11
Electrical connection ...................................................................................... 11
First operation................................................................................................ 12
Adjusting the output air pressure ................................................................... 12
OPERATION ........................................................................................................... 12
Switching the compressor on ........................................................................ 13
Running the compressor ............................................................................... 13
Cleaning the compressor ............................................................................... 13
5. MAINTENANCE .......................................................................................................... 14
REPAIRS AND SERVICE ....................................................................................... 14
Cover removal ............................................................................................... 14
MAINTENANCE SCHEDULE ............................................................................... 15
Checking tightness of joints and inspecting the equipment ........................... 16
Replacing filter elements ............................................................................... 17
Changing suction filter elements.................................................................... 17
Securing the equipment before transport ...................................................... 18
SHUTDOWN ........................................................................................................... 18
EQUIPMENT DISPOSAL ........................................................................................ 18
6. TROUBLESHOOTING ................................................................................................ 19
7. SPARE PARTS ........................................................................................................... 20
8. ELECTRIC AND PNEUMATIC DIAGRAMS ............................................................... 21
WIRING DIAGRAM ................................................................................................. 21
PNEUMATIC DIAGRAM ......................................................................................... 21
9. ELECTROMAGNETIC COMPATIBILITY DECARATION ........................................... 23
10. ANNEX ........................................................................................................................ 98
INSTALLATION RECORD ...................................................................................... 98
GENERAL INFORMATION
NP-DK50 DE-LF-16_09-2023 3
1. GENERAL INFORMATION
INTENDED USE
The EKOM DK50 DE is a medical air compressor that supplies clean, oil-
free compressed air for use with medical ventilators.
CONTRAINDICATIONS AND SIDE-EFFECTS
There are no contraindications or side-effects known.
OPERATOR'S RESPONSIBILITY FOR PATIENT SAFETY
Instructions for use 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
US Federal law restricts the sale of this device by or on the order of a
physician.
MARKINGS
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
- The equipment is used in accordance with the Installation, Operation and
Maintenance Manual
The Installation, Operation and Maintenance 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.
GENERAL INFORMATION
4 NP-DK50 DE-LF-16_09-2023
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
anesthetics.
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
The equipment must be connected to ground. I order to assure proper
grounding, connect the compressor to a receptacle marked "hospital
grade."
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 DE-LF-16_09-2023 5
WARNING NOTICES AND SYMBOLS
The following symbols are used for important information in the Installation,
Operation and Maintenance Manual and on packaging and the product:
Attention, see instructions for use
Caution, risk of electric shock
Refer to instruction manual
CE mark of compliance
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
GENERAL INFORMATION
6 NP-DK50 DE-LF-16_09-2023
Ground connection
Equipotentiality
Fuse
Condensate drain
Never dispose of the battery with common household waste.
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.
Prior to transport it is necessary to secure the motor inside the
compressor (Chapter 5).
EQUIPMENT DESCRIPTION
NP-DK50 DE-LF-16_09-2023 7
2. EQUIPMENT DESCRIPTION
1. OUT - compressed air outlet
2. Pressure regulator
3. Output air pressure gauge (with accuracy of ± 5%)
4. Hour meter
5. Switch, power connector and fuses
6. Power cord anchor
7. Equipotential connector
8. Compressor
9. Suction filter
10. Fan
11. Safety valve
12. Filter (5 μm) with automatic condensate drain
13. Supporting base
14. Cooler
15. Regulator safety cover
The equipment uses an oil-free piston compressor (8) driven by a low-maintenance
electric motor. Compressed air is cooled in the cooler (14) where condensed water is
separated into a separate tank (12). Compressor working pressure is set using the safety
valve (11). Constant output pressure is maintained by the pressure regulator (2).
EQUIPMENT DESCRIPTION
8 NP-DK50 DE-LF-16_09-2023
TECHNICAL DATA
NP-DK50 DE-LF-16_09-2023 9
3. TECHNICAL DATA
TYPE
DK50 DE
VERSION
low flow
Output flow at pressure
3.5 bar (51 psig)
L/min
20
Voltage / Frequency / Rated current
V/Hz/A
230/50 / 2.3
230/60 / 2.3
110-120/60 / 4.4
Air filtration
m
5
Pressure dew point at 3 bar, 20°C, 50%
Relative air humidity
5°C (9°F) below the ambient temperature
Outlet connection
DISS 1160-A (3/4"-16 UNF)
Sound level
dB(A)
48
49 / 60 Hz
Mode of operation
Continuous - S1
Separation of condensed water
Automatic
Output pressure
3.0 bar (43 psig)
Adjustable to max. 3.5 bar (51 psig)
Pressure range
5 bar ( 72.5 psig )
Adjustment of output air pressure
Pressure regulator
Dimensions of compressor
w x d x h
395 x 270 x 400 mm (10.5 x 15.5 x 16 in )
Dimensions of packaging
w x d x h
460 x 350 x 500 mm ( 14 x 18 x 19.5 in )
Net weight
23 kg ( 51 lbs )
Gross weight
29 kg ( 64 lbs )
Implementation according to EN 60601-1, EN
12021
Class I.
Classification acc. to MDD 93/42 EEC, 2007/47
EC
II b
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 +15°C to +40°C (+59°F to +104°F)
Relative air humidity up to +70%
IPX0 Rating
FAD efficiency correction for differences in elevation
FAD correction table
Elevation [mamsl]
0 - 1500
1501 - 2500
2501 - 3500
3501 - 4500
FAD [l/min]
FAD x 1
FAD x 0.8
FAD x 0.71
FAD x 0.60
FAD efficiency refers to conditions at an elevation of 0 mamsl:
Temperature: 20°C
Atmospheric pressure: 101325 Pa
Relative humidity: 0%
OPERATION
10 NP-DK50 DE-LF-16_09-2023
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.
Before starting the compressor for the first time the stabilisation
elements used to support the equipment during transport must be
removed. Starting the compressor without removing the stabilisation
elements can permanently damage the equipment!
The compressor does not contain a backup power supply.
It is forbidden to block the ventilation openings located in the upper
part 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 instruments, the equipment must
be observed in order to verify normal operations in the configuration it
will be used.
Instruments 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
NP-DK50 DE-LF-16_09-2023 11
Removal of transport stabilizers
Remove the four screws from the side of the equipment. Remove the cover
and disconnect the ground wire.
Remove the two (2) M6 screws market with the red warning washers and
remove the stabilisation elements
Keep the screws and stabilisation elements in the event the compressor is
transported at a later time.
Connect the grounding wire and reattach the cover.
Compressed air connection
The given appliance or respiratory apparatus should be connected to the
OUT (1) quick coupler, as this is the outlet for compressed air.
The hose connecting the compressor to the respiration equipment
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.
OPERATION
12 NP-DK50 DE-LF-16_09-2023
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.
Connection of the ground connection (7) to other equipment must adhere
to local electrical regulations.
Fasten the electrical cord through the holder (6).
First operation
Make sure that the stabilizing screws used during transport were
removed.
Check that the connection to the compressed air supply is correct.
Check for proper connection to the main power supply.
Switch on the pressure switch (5) to position “I”.
The compressor will be operational once it is put into operation.
During equipment operation condensed water is released from the
compressed air circuit through the automatic separator in the filter and
drained to the evaporation tank.
Adjusting the output air pressure
The manufacturer has pre-set the output air pressure to 3 bar. If needed the
output air pressure can be adjusted by turning the handle on the pressure
regulator (2). The safety cover (15) must be removed before adjusting the
output pressure. Push up the regulator knob and adjust the setting; once set,
push it back down to secure its position. Reinstall the safety cover!
The maximum allowed output air pressure is 3.5 bar. Damage to respiration
equipment may occur at higher outlet air pressures due to the presence of
condensed water in the compressed air exiting the equipment.
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.
OPERATION
NP-DK50 DE-LF-16_09-2023 13
Switching the compressor on
The compressor is switched on at the main power switch (1) by putting it in
position "I".
Running the compressor
The compressor runs permanently once switched on. Condensed water
removed from the compressed air evaporates from the evaporation tank back
into the surrounding environment. The pressure gauge displays the outlet air
pressure.
Cleaning the compressor
To clean the compressor, use a detergent that contains no abrasives,
chemical solvents or other corrosive agents.
MAINTENANCE
14 NP-DK50 DE-LF-16_09-2023
5. MAINTENANCE
REPAIRS AND SERVICE
Warranty and extended warranty repairs are to be completed by the
manufacturer or a service provider authorized by the manufacturer.
The manufacturer reserves the right to modify the equipment in any
way that will not alter the function or the operation of the equipment.
Only a qualified technician or the Customer Service Department of the
manufacturer may perform repairs that go beyond routine maintenance.
Use only spare parts and accessories approved by the manufacturer.
Prior to any maintenance or repairs, switch off the compressor and
disconnect it from the mains (pull out the main power plug).
Air pump components (head, cylinder, pressure hose, etc.) are very hot
during and shortly after compressor operation do not touch these
components!
Allow the equipment to cool down before maintenance, service or
connecting/disconnecting the compressed air supply!
Automatic start: when pressure in the pressure tank decreases below
the switch-on pressure, the compressor automatically switches on. The
compressor automatically switches off when pressure in the air tank
reaches the switch-off pressure.
Cover removal
- Remove the four screws from the side of the equipment.
- Remove the cover
- Disconnect the grounding conductor
- Reassemble using the opposite order
MAINTENANCE
NP-DK50 DE-LF-16_09-2023 15
MAINTENANCE SCHEDULE
Notice!
The operating entity is obliged to ensure that all tests of the equipment are carried
out repeatedly at least once within every 24 months (EN 62353) or in intervals as
specified by the applicable national legal regulations. A report must be prepared on
the results of the tests (e.g.: according to EN 62353, Annex G), including the
measurement methods used.
Maintenance
Page
Time interval
To be
performed by
Replace filters in filter
13
Every 4000 hours
Qualified expert
Test the tightness of joints and
inspect the equipment
16
After two years
Qualified expert
Replace piston complete with
piston rings, O-rings and bearing
Service
documentation
Every 8000 hours
Qualified expert
Replace suction filter
17
Every 8000 hours
Qualified expert
Perform “Repeated Test”
according to EN 62353
15
1 x 2 years
Qualified expert
MAINTENANCE
16 NP-DK50 DE-LF-16_09-2023
Checking tightness of joints and inspecting the equipment
Test for leakage:
Disconnect the outlet hose from the quick coupling OUT (1); compressed
air consumption will stop.
Switch off the compressor
Use soapy water to check for leaks in connections
Tighten or re-seal joints as necessary.
Inspect the equipment:
Check the status of the compressor motor for balanced operation or noise.
Check the condition of the hangers above the pump.
Check fan functionality.
Check the working pressure values. Make sure the control knob on the
pressure regulator (2) and the relief valve (11) are securely closed. The
knob must be pulled up before setting the pressure or pushed down once
the pressure has been set. Turn the pressure regulator (2) knob in the (+)
direction until its maximum position is reached. Turn on the compressor
and set the air consumption to around 10 L/min. Check the working
pressure on the pressure gauge is at 5 bar; if this value needs to be
changed, adjust the pressure using the knob on the relief valve (11). Turn
this knob (2) to set the output pressure (normally 3 bar) at consumption of
around 10 L/min.
Check the condition of filter (12). With regular operation, condensate
drains automatically. Verify this function by comparing the level of
condensate in the tank to the scale line indicating the maximum level. If
the level of condensate is above the scale line, replace the faulty parts.
Examine the pump for:
- Defects in the crankcase
- Free movement of the crank shaft
If necessary, replace any faulty parts.
MAINTENANCE
NP-DK50 DE-LF-16_09-2023 17
16
Replacing filter elements
Prior to servicing the equipment, reduce the pressure to zero and
disconnect the equipment from the main power supply.
Unscrew the cover and pull it out using the enclosed wrench (16).
Unscrew the filter holder.
Replace the filter and screw the filter holder
into place.
Screw the cover back in place.
Spare filtration pad:
Plastic (5 μm) (12) AF20P-060S Item 025200113-000
If the water release system becomes clogged, disassemble the release valve
(f), clean the outlet, remove the float (b) with a lever mechanism (c, d, and e)
from the tank, clean all components with a soap solution and then
reassemble.
Changing suction filter elements
Raise the clasps on the cover (9) and remove the cover.
Replace the filter element. Filters that are only slightly dirty can be cleaned
using compressed air. Filters can be washed.
Reposition the cover.
Replacement parts:
Suction filter 03 POLYESTER, No. 025200126-000
MAINTENANCE
18 NP-DK50 DE-LF-16_09-2023
Securing the equipment before transport
The equipment must be secured before any type of transport. Proceed using
the opposite order of the procedure shown in Chapter 4 in the section for
releasing the compressor.
SHUTDOWN
If the compressor is not going to be used for a long period of time,
disconnected it from the main power supply and release the pressure.
EQUIPMENT DISPOSAL
Disconnect the equipment from the main power supply.
Release the pressure.
Dispose of the equipment according to local regulations.
Parts used in this product have no negative impact on the environment
when disposed of properly.
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EKOM DK50 DE Používateľská príručka

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