Megro Ratiomed AC 20, Ratiomed AC 30 User manual
Doc.-no.: AC20/AC30 V1/01/05
Revision: –
Operating Instructions
Ratiomed AC 20/AC 30
Date: January 2006
Prior to starting up the Ratiomed AC 20/AC 30, read these
operating instructions carefully and store them near the unit for later reference!
Mains-operated
Suction Units
0482
GmbH & Co. KG
Am Schornacker 30
D-46485 Wesel
Tel.: +49 (0) 281 - 98990 www.megro.de
Fax: +49 (0) 281 - 989950
E-Mail: info@megro.de
Table of contents
1.0 GENERAL ................................................................................................................................................................... 3
1.1 Standard equipment ................................................................................................................................................3
1.2 Delivery.................................................................................................................................................................... 3
1.3 Explanation of symbols............................................................................................................................................ 3
1.4 For your safety – CAUTION!.................................................................................................................................. 4
1.5 Application range ..................................................................................................................................................... 5
1.6 Notes on EMC ......................................................................................................................................................... 5
1.7 Warranty .................................................................................................................................................................. 8
1.8 Technical Data......................................................................................................................................................... 9
2.0 CONNECTION, START-UP AND OPERATION ....................................................................................................... 10
2.1 Functions ............................................................................................................................................................... 10
2.2 Start-up .................................................................................................................................................................. 10
2.3 Operation ............................................................................................................................................................... 11
3.0 CLEANING AND SERVICING ..................................................................................................................................12
3.1 Collection jar: how to evacuate it ........................................................................................................................... 12
3.2 Collection jar and housing: how to clean them .....................................................................................................12
3.3 Cleaning and disinfection....................................................................................................................................... 12
3.4 Filter....................................................................................................................................................................... 13
3.4.1 Filter: general function ........................................................................................................................................... 13
3.4.2 Filter: how to replace it........................................................................................................................................... 13
4.0
TROUBLE-SHOOTING............................................................................................................................................. 14
4.1 Fuse: how to replace it........................................................................................................................................... 14
5.0 CONSUMABLES, SPARE PARTS AND ACCESSORIES ....................................................................................... 15
5.1 Consumables......................................................................................................................................................... 15
5.2 Spare parts ............................................................................................................................................................ 15
5.3 Accessories ........................................................................................................................................................... 16
5.3.1 Accessories: Receptal ........................................................................................................................................... 16
5.3.2 Accessories: MediVac ........................................................................................................................................... 16
5.3.3 Accessories: additional .......................................................................................................................................... 16
6.0 MAINTENANCE AND REPAIR................................................................................................................................. 17
7.0 DISPOSAL ................................................................................................................................................................ 17
8.0 LEGAL INFORMATION ............................................................................................................................................ 17
9.0 INDEX........................................................................................................................................................................ 18
10.0
FURTHER INFORMATION ............................................................................................................................................. 20
DECLARATION OF CONFORMITY ............................................................................................................................... 20
11.0
The document is subject to technical alterations!
© Reproduction of this document, even in part, is not permitted. Contents shall not be reproduced, duplicated or given to
third party, either in full or in part, without the written authorisation of megro GmbH.
In case of ambiguity with regard to textual contents or translations, only the German original editions are valid.
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1.0 GENERAL
These operating instructions apply for following units:
Ratiomed AC 20 ..................................... REF 8710401
Ratiomed AC 30 ..................................... REF 8710501
in combination with the accessories mentioned in chapter
5.3 as well as for all identically constructed units with
special voltages and special colours respectively.
1.1 Standard equipment
Ratiomed AC 20/AC 30:
2 Collection jars
Bacterial filter
1 Lid S6 with overflow safety
Silicone hose (6mm internal diameter)
Finger tip
Hose connector
CAUTION!
The mentioned units are identical with regard to
construction and handling. They only differ in their
technical data – see chapter 1.8.
1.2 Delivery
The Ratiomed AC 20/AC 30 was subjected to a thorough
quality control and carefully packed before shipment.
Nevertheless, please immediately compare the contents
of the carton with the enclosed delivery note. In case of
transport damages, please immediately contact
megro in Wesel or the competent supplier (addresses
on the last page of these operating instructions). Return
shipment of the unit (e.g. for repair) should only be
effected in an undamaged shipping carton.
1.3 Explanation of symbols
„Caution: pay attention to operating
instructions“ acc. to DIN EN 980:2003.
This symbol accentuates important
information in the operating instructions.
Degree of protection:
Type BF (Body Floating)
Short-time operation
Protection class II
Vacuum low-high
Turn the adjust knob to
increase/decrease the vacuum value
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1.4 For your safety – CAUTION!
The safety standard of the Ratiomed AC 20/AC 30
corresponds with recognized medical technical
regulations and the directions of the law relating to
medical products.
The Ratiomed AC 20/AC 30 has been designed acc.
to EEC Directive 93/42/EEC Annex IX and has
been classified as suction unit of Class lla.
The product Ratiomed AC 20/AC 30 bears the
CE identification symbol CE0482 in accordance
with the EEC Medical Devices Directive - Directive
93/42/EEC and meets the basic requirements of
Annex I to this Directive.
The quality management system used at megro
has been certified in accordance with the relevant
international standards.
The Ratiomed AC 20/AC 30 meets the immunity to
interference requirements of IEC 601-1-2/
EN 60601-1-2 „Electromagnetic compatibility Medical Electrical Devices“. Electromagnetic
interference and interaction are thus reduced to a
minimum.
The Ratiomed AC 20/AC 30 may only be applied by
persons who have been trained in its operation acc. to
the instruction guidelines of megro.
Prior to connecting the power plug, make sure that the
main voltage specified on your unit corresponds with
the in building voltage.
Never connect the unit to defective power sockets.
Keep the unit away from external heat sources.
Check function of the unit prior to use.
The suction hose must never come into direct contact
with the application site. A suction catheter, suction
attachment or a medical suction instrument must
always be connected to the hose.
The unit must not be operated without bacterial filter.
The unit must not be operated in damp rooms, in
outdoor ranges or when taking a bath or shower.
Avoid moisture on plug and switches. Never plunge
the unit into water or other liquids, not even when it is
switched off.
The unit must not be operated in splash water range
and in locations where there is a danger of explosion.
Pay attention to the ambient conditions described in
the technical data.
Only operate the unit in upright position and on a firm,
level surface.
The unit may only be operated under supervision.
The unit may not be started:
if cable or plug are defective;
if it has been dropped down before;
if obvious defects might restrict safe operation;
if it has been dropped into water.
In any case, remove power plug from the mains
socket and have the unit checked by qualified
personnel authorized by megro.
In regular intervals, parts of the unit must be checked
for proper function and safety-related defects, e.g.
plug and socket connections, collection jar, housing
etc.
Opening the unit may only be performed by qualified
personnel authorized by megro. Only use original
accessories and spare parts.
The Ratiomed AC 20/AC 30 has been designed for
aspirating body fluids in medical ranges.
It must never be used to remove explosive gases and
inflammable or corrosive fluids.
Remove power plug from the mains socket:
before cleaning and maintaining the unit;
before evacuating the collection jar.
Always pull at the plug, never pull at the cable!
When operating the unit at ambient temperatures
outside the stated temperature range (see technical
data), the performance may be reduced.
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1.5 Application range
Application ranges of the Ratiomed AC 20/AC 30 are in
hospital and medical practice as well as at home.
The Ratiomed AC 20/AC 30 is a mains-operated suction
unit for removing secretions, blood and body fluids.
The vacuum can be adjusted using the regulating valve
and the vacuum gauge. The suction hose must never
come into direct contact with the application site. A
suction catheter or an adequate suction cannula with
or without exhaust air valve must be connected to the
hose.
The Ratiomed AC 20/AC 30 may not be used:
for drainages in low vacuum range (e.g. thorax
drainage) and for suction procedures outside medical
ranges;
for the suction of inflammable, corrosive or explosive
fluids/gases.
In regular intervals, parts of the unit must be checked for
proper function and safety-related defects, e.g. plug and
socket connections, collection jar, housing etc.
CAUTION!
Disregard of these safety advices may lead to
damage to property and persons.
Megro GmbH cannot be held liable for damages to
property and persons if this unit is used without
observing the instructions in this manual.
1.6 NOTES ON EMC
Medical electrical equipment is subject to special precautions with regard to electromagnetic compatibility and must be
installed acc. to following EMC notes.
Portable and mobile HF communication facilities can influence medical electrical equipment.
T201
The Ratiomed AC 20/AC 30 is intended for use in the electromagnetic environment specified below. The customer or user of
the Ratiomed AC 20/AC 30 should ensure that it is used in such an environment.
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-2
Emissions Test Compliance Electromagnetic Environment - Guidance
Class B
Class A
Complies
The Ratiomed AC 20/AC 30 is suitable for use in
all establishments, including domestic, and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
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T202
The Ratiomed AC 20/AC 30 is intended for use in the electromagnetic environment specified below. The customer or user of
the Ratiomed AC 20/AC 30 should ensure that it is used in such an environment.
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environment-
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transients (EFT)/
bursts
IEC 61000-4-4
Surges
IEC 61000-4-5
Voltage Dips/
Dropouts
IEC 61000-4-11
Power Frequency
50Hz
IEC 61000-4-8
NOTE: UT is the mains alternating current prior to application of the test levels.
±6kV Contact
±8kV Air
±2kV Mains
±1kV I/Os
±1kV Differential
±2kV Common
<5% UT (>95% Dip of
) for 0.5 Cycle
the U
T
(60% Dip of
40% U
T
) for 5 Cycles
the U
T
(30% Dip of
70% U
T
) for 25 Cycles
the U
T
(>95% Dip of
<5% U
T
) for 5 s
the U
T
±6kV Contact
±8kV Air
±2kV Mains
±1kV I/Os
±1kV Differential
±2kV Common
(>95% Dip of
<5% U
T
) for 0.5 Cycle
the U
T
(60% Dip of
40% U
T
) for 5 Cycles
the U
T
(30% Dip of
70% U
T
) for 25 Cycles
the U
T
(>95% Dip of
<5% U
T
) for 5 s
the U
T
3 A/m 3 A/m Power frequency magnetic fields should
Guidance
Floors should be wood, concrete, or
ceramic tile. If floors are synthetic, the
relative humidity should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
Ratiomed AC 20/AC 30
demands
continued function even in case of
interruptions of the power, it is
recommended to supply the
Ratiomed AC 20/AC 30
from an
uninterruptible current supply or a
battery.
be that of a typical commercial or hospital
environment.
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