ENG
Instructions for use
automatic pressure controller
Version 2018-07-31
40-202-01
IMPORTANT
These directions are essential for operating the device. They must
therefore be kept in a suitable place near the device, and should be kept
with the device if it is given to other users.
This manual is valid for devices with serial number 381000 or higher.
For proper and safe use of this device, it is essential that the following
warnings and safety instructions, as well as the operating instructions,
are read and carefully observed by all users before first using the device.
It is the responsibility of those using the device to fully acquaint
themselves with its proper use and operation. If a malfunction is
suspected, the device is to be taken out of service immediately and
suitable warning signs should be attached to the device to ensure that it
is not used before the required service and repair work has been carried
out.
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TABLE OF CONTENTS
1. Warnings and Safety Instructions ............................................................. 4
2. Description .................................................................................................. 6
2.1 General Discription ..................................................................................... 6
2.2 Scope of Delivery ........................................................................................ 6
3. Initial Operation ........................................................................................... 7
4. Maintenance ................................................................................................ 9
5. Cleaning and Disinfection .......................................................................... 9
6. Periodic Inspections ................................................................................. 10
7. Manufacturer Liability ............................................................................... 10
8. Warranty Conditions ................................................................................. 11
9. Return of Devices ...................................................................................... 12
10. Disposal ................................................................................................... 12
11. Symbols ................................................................................................... 13
12. Operating and Storage Conditions ........................................................ 14
13. EMC Tables .............................................................................................. 14
14. Technical Data ......................................................................................... 18
15. Manufacturer’s Declaration .................................................................... 19
16. Manufacturer ........................................................................................... 19
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1. WARNINGS AND SAFETY INSTRUCTIONS
In the event of any suspected malfunction while in operation, the device should
be immediately removed from service.
Unplugging the mains plug is the only safe way to disconnect from the mains
power supply.
The device may only be fastened to infusion stands, tripods or equipment rails
which have sufficient stability and load capacity to support the device.
Only pressure infusion bags specified by BIEGLER or approved by BIEGLER
for use with this device may be used in conjunction with the autopress.
The device must only be used in areas in which the electrical installations are in
accordance with the standards and regulations in force.
The device must not be used in rooms with potential explosion hazard.
The device must not be immersed in liquids or sterilized with steam or by
thermochemical methods.
All extraneous influences such as electromagnetic waves or high temperatures
are to be kept to a minimum.
Avoid exerting force on the device or its accessories.
If the device is dropped, damaged due to force, or functions in a way other than
described in the operating instructions, stop using the device immediately and
return it to the service centre.
Periodic technical safety inspections must be carried out as described in the
"Periodic inspections" section.
Persons and services authorized by BIEGLER must carry out repairs and
modifications on the device.
No mechanical or electrical changes may be made to the components of the
device.
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Only infusion bags that are capable of 300 mmHg must be used. Adhere to the
instructions for use for this bags.
The pressure infusion bags must be securely fastened at least 20 cm above the
patient to prevent air embolism. Prevent the connecting hose from kinking.
Always position the autopress in such a way that it is easy to operate without
obstacles. No other devices or infusion stands shall be positioned shortly before.
Make sure, that mains plug of the autopress is easily reachable to the operator.
(The mains plug is used to disconnect the device from mains)
The automatic pressure controller autopress is a class I ME equipment and
therefore only intended to be connected to supply mains with protective earth.
The autopress may not be used if:
the housing is damaged or one of the front film layers becomes detached
the device has been exposed to a hard physical shock (e.g. dropped, hit or
shaken)
the device has been immersed in water
the mains power cord or plug is damaged
the device has given someone an electric shock
the fixing clamp is damaged in such a way that safe clamping to the infusion
stand is no longer guaranteed.
The autopress may not be used if there is a malfunction:
e. g. display error, no pressure, …
If there is a malfunction, suitable warning signs should be attached to the device
to ensure that it is not used until the required service and repair work has been
carried out.
Safety Instructions for consumable materials:
Consumables are only for one-time use (disposable). The reuse of disposable
products results in possible infection risks for the patient or user.
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2. DESCRIPTION
2.1 GENERAL DISCRIPTION
Description Article number
autopress LG4000003
The automatic pressure controller autopress is used when liquids are to be
supplied under constant pressure.
The autopress can be used in combination with all BIEGLER Blood- and
Infusionwarmers or used as standalone device.
Only the following single-use pressure infusion bags can be used:
Description Article number
BIEGLER Pressure Infusion Bag 500 ml JR2000500
BIEGLER Pressure Infusion Bag 1000 ml JR2001000
BIEGLER Pressure Infusion Bag 3000 ml JR2003000
2.2 SCOPE OF DELIVERY
Quantity Description
1 autopress
2 BIEGLER Pressure Infusion Bag 500 ml
1 Instructions for use
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3. INITIAL OPERATION
Observe the instructions for use! Handling of this device requires
knowledge and adherence to these instructions. The autopress and
accessories may only be used by physicians, physician assistants or
other qualified specialized staff. The condition of the patient has to be
monitored during the application.
1. Fix the autopress firmly on a stand using the clamps at the
back. Only use infusion stands, tripods or equipment rails
that are sufficiently stable.
2. Before connecting to the mains power supply, check that the
voltage specified on the device label matches the mains
voltage.
3. Before switching on the device place the infusion bag in an
appropriate pressure infusion bag and then connect the
infusion to the patient.
4. Connect the pressure infusion bag to the Luer-Connector of
the autopress
5. Switch on the device by pressing the button in the upper
right.
Figure 1 - placing the
infusion bag
6. Set the desired pressure with the arrow buttons and .
(in steps of 10 mmHg)
7. Start the pressure build-up by pressing the START-buttons or to the
corresponding channel.
8. If necessary the pressure in both channels can be changed by pressing the
and buttons.
9. By pressing the PAUSE-button the pressure in the corresponding channel is
released and the channel is vented.
If the patient has to be moved the device can be unplugged without switching off
– the pressure is maintained.
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Operation:
clamp
set pressure
ratio
actual to set
pressure
actual pressure
vent left
channel
activate left
channel
ON / OFF
Power supplied
Standby-LED
increase
pressure
vent right
channel
activate right
channel
8
decrease
pressure
Figure 2 - Operation, Display
4. MAINTENANCE
The autopress was largely designed as a maintenance-free device. For long-term
maintenance of quality and functional safety, we would like to ask you to observe
the following points:
Always keep the device clean (see the "Cleaning and disinfection" section).
Periodic technical safety inspections must be carried out as described in the
"Periodic inspections" section.
5. CLEANING AND DISINFECTION
Important: Before cleaning or disinfecting, the device must always be
disconnected from the mains power supply by pulling the plug.
The device may only be cleaned using a soft cloth with a water-soluble, nonaggressive cleaning agent or a special cleaning agent for plastics.
For the purposes of disinfection, only ready-made alcohol-based spray
disinfectants (e.g. Meliseptol Foam pure, BRAUN) must be used and the
manufacturer‘s instructions must be followed.
Do not disinfect the device with steam (i.e. in autoclaves), hot air or
thermochemical cleaning solutions.
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6. PERIODIC INSPECTIONS
The periodic technical safety inspections (according to the local standards in force
- e.g. in Austria, EN 62353) on the autopress must be carried out at least every
12 months, by persons authorized to carry out such inspections based on their
training, knowledge and practical experience. The device cannot be used during
inspection. The pressure limitation, as essential performance of the device, is
tested during inspection.
The device should be checked for mechanical damage (general condition) and for
the completeness of the device label.
Furthermore, the device must not display any contamination or corrosion which
could impair safety, particularly in the area of the plug connector.
If there is mechanical damage to the device which could cause risk of injury or
impair its functionality, this constitutes a malfunction.
The results of the periodic inspection must be documented, along with the date,
the inspecting agency and the device number.
Important: If a malfunction is discovered during the periodic inspection,
suitable warning signs should be attached to the device to ensure that it
is not used before the required service and repair work has been carried
out.
7. MANUFACTURER LIABILITY
The manufacturer and the supplier of the device reject any liability if:
the device is not used in accordance with the directions for use.
the user is not sufficiently informed about the functioning of the device
corresponding with the directions for use and the safety instructions
repairs are not performed exclusively by the manufacturer or by persons and
service centers expressly authorized by the manufacturer
the device is used in places in which the electrical installations do not comply
with the applicable national standards, or if the power supply during the
period of use of the device is not guaranteed
original spare parts are not used or the maintenance interval is not adhered
to.
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8. WARRANTY CONDITIONS
The manufacturer guarantees that all flaws of material and
workmanship which arise within 24 months from the date of purchase
will be repaired free of charge.
Claims are only accepted under the following terms:
The manufacturer and/or supplier is informed immediately of the
fault for which the warranty claim is being made.
The instructions of the manufacturer and/or supplier regarding
storage or return of the device are complied with.
Presentation of a legible copy of the invoice for the device
concerned, showing the date of purchase.
An exact description of the defects or malfunctions identified by the
customer.
The manufacturer's warranty will be void if it is found that the
maintenance, disinfection and inspection instructions have not been
followed according to the operating instructions, the device has been
damaged by force or operating error, or has been used in any way
contrary to the operating and safety instructions. The warranty will also
be void if original BIEGLER materials were not used as replacement
parts, or measures for repair were undertaken by persons not
authorized by the manufacturer or supplier.
If the manufacturer is required to meet a warranty claim in accordance
with these terms, the customer shall bear the costs and risks of transport
of the device from and to the place of use.
The manufacturer and/or supplier shall under no circumstances assume
liability for slight negligence. The compensation for lost earnings and
profits is likewise excluded.
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9. RETURN OF DEVICES
Devices must be carefully cleaned and disinfected before being placed in the
original packaging for returning.
If the original packaging is no longer available, the product has to be suitably
packaged for the method of dispatch.
10. DISPOSAL
Dispose of the device at the end of its expected service life and its accessories in
accordance with the applicable local regulations.
Do not dispose of this product
as unsorted municipal waste
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11. SYMBOLS
compliance with Directive
Serial number
93/42/EEC
Consult instructions for use
Attention, consult
accompanying documents
Defibrillation-proof type CF
Catalogue number
Manufacturer
manufacturing date
applied part
On / OFF
activate right channel
AC voltage
increase pressure
activate left channel
decrease pressure
Degree of protection
pause button –
IPX4
against ingress of water -
vent the channel
splashing water
Batch code
Latex free
Fragile, handle with care
Keep dry
Use by
Humidity limitation
Temperature limit
Protect from heat and
radioactive sources
Do not dispose of this product
as unsorted municipal waste
authorized in the European
Community
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12. OPERATING AND STORAGE CONDITIONS
Permissible environmental conditions for transporting and storing the autopress
and accessories:
Transport and storage Operating
Temperature 10 – 40 °C 10 – 30 °C
Relative humidity 30 – 75 % 30 – 75 %
Ambient pressure 700 – 1060 hPa 700 – 1060 hPa
Values higher or lower than the ranges specified above may cause
damage to the device or its accessories.
13. EMC TABLES
Table 1
Guidelines and manufacturer's declaration – electromagnetic emissions
The autopress is intended for use in the environment specified below. The customer or the user of the
autopress should ensure that it is used in such an environment.
Interference
emission
measurements
RF emissions
acc. to CISPR 11
RF emissions
acc. to CISPR 11
Emission of
harmonics
according to
IEC 61000-3-2
Emission of
harmonics
according to IEC
61000-3-3
Compliance Electromagnetic environment - guidelines
Group 1
Class B The autopress is suitable for use in all establishments, including domestic
Class A
Compliant
The autopress uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference to
nearby electronic equipment.
establishments and those directly connected to the public power supply
network that also supplies buildings used for domestic purposes.
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Table 2
Guidelines and manufacturer's declaration – electromagnetic interference resistance
The autopress is intended for use in the electro-magnetic environment specified below. The customer or the
user of the autopress should assure that it is used in such an environment.
Interference
resistance test
Electrostatic
discharge
IEC 61000-4-2
Fast transient
/electrical bursts
acc. to IEC 61000-44
Surges as per
IEC 61000-4-5
Voltage dips, short
interruptions
and voltage
variations of the
supply voltage
acc. to IEC 61000-411
IEC 60601-test
level
± 8 kV contact
± 15 kV air
± 2 kV
100kHz repetition
frequency
± 1 kV
differential mode
± 2 kV
common mode
< 5 % UT
(> 95 % fall in U
T
for ½ period
40 % U
(60 % fall in U
T
)
T
for 5 periods
70 % U
(30 % fall in U
T
)
T
for 25 periods
< 5 % U
(> 95 % fall in U
T
T
for 5 s
Compliance
level
± 8 kV contact
± 15 kV air
± 2 kV
100kHz repetition
frequency
± 1 kV
differential mode
± 2 kV
common mode
< 5 % U
(> 95 % fall in U
)
T
for ½ period
40 % U
T
(60 % fall in U
for 5 periods
70 % U
T
(30 % fall in U
for 25 periods
< 5 % U
(> 95 % fall in U
)
T
for 5 s
Electromagnetic environment guideline
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
The mains power supply quality should be
that of a typical commercial or hospital
environment.
The mains power supply quality should be
that of a typical commercial or hospital
environment.
)
T
The mains power supply quality should be
that of a typical commercial or hospital
environment.
If the user of the autopress requires
continued operation even in the case of
)
T
power supply interruptions it is
recommended to connect the autopress
to an uninterruptible power source or a
battery.
)
T
)
T
Power frequency
(50 Hz/60 Hz)
magnetic field IEC
61000-4-8
3 A/m 3 A/m Magnetic fields at this power frequency
should be at levels characteristic of a
typical location in a typical commercial or
hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.
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Table 4
Guidelines and manufacturer's declaration – electromagnetic interference resistance
The autopress is intended for use in the electro-magnetic environment specified below. The customer or the
user of the autopress should ensure that it is used in such an environment.
Interference
resistance test
IEC 60601test level
Compliance
level
Electromagnetic environment - guidelines
Portable and mobile RF communications equipment
should be used no closer to any part of the autopress,
including cables, than the recommended protection
distance calculated from the equation applicable to the
frequency of the transmitter:
Recommended protection distance:
Conducted RF
disturbance variables
acc. to
3 V
eff
150 kHz to 80
MHz
1V
in V
IEC 61000-4-6
Radiated RF
disturbance variables
according to IEC
3 V/m
80 MHz to 2.5
GHz
in V/m
1E
for 80 MHz to 800 MHz
61000-4-3
for 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended protection
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
should
be less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strengths from stationary transmitters, such as base stations for radio (cellular /cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment resulting from stationary RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the autopress is used exceeds the applicable RF compliance level above, the
autopress should be observed to verify normal operation. If abnormal performance characteristics are
observed, additional measures may be necessary, such as reorienting or relocating the autopress.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
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Table 6
Recommended safety distances between
portable and mobile RF telecommunications devices and the autopress
The autopress is intended for use in an electromagnetic environment in which radiated RF disturbance
variables are controlled. The customer or user of the autopress can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the autopress as recommended below, according to the maximum output power of the communications
equipment.
Protection distance according to transmitter frequency m
Rated maximum
output power
of transmitter W
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended distance can be
determined using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
150 kHz to 80 MHz
absorption and reflection from structures, objects and people.
80 MHz to 800 MHz
800 MHz to 2.5 GHz
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14. TECHNICAL DATA
Device: automatic pressure controller
Type designation: autopress
Operating voltage: 100 – 240 Vac / 50 – 60 Hz
Power consumption: max. 36 VA
Supply type: mains operation
Protection class: I
Degree of protection
against electric shock Type CF, defibrillationproof
IP-classification (IEC 60529): IPX4
Classification (93/42/EEC): IIa according to Rule 9
Operation mode: continuous
Pressure range: 0 – 300 mmHg
Accuracy of values displayed: ± 5% of the measured value
Dimensions: 100 x 230 x 180 mm
Weight (device only): 2.1 kg
Applied part: venous access (not included)
Figure 3 – Applied part depiction
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to patient
15. MANUFACTURER’S DECLARATION
The autopress is a medical product as defined by Directive 93/42/EEC.
This is documented through the CE mark.
Notified Body: TÜV SÜD Product Service, Approval Number CE0123
16. MANUFACTURER
Biegler GmbH
Allhangstrasse 18a
3001 Mauerbach
AUSTRIA
Tel. +43 1 979 21 05
Fax +43 1 979 21 05 16
office@biegler.com
www.biegler.com
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