Basic Safety Instructions - Attention - Lowenstein Medical Allegra M30 Mode D'emploi

1 User information

1.6 Basic safety instructions - ATTENTION!

Warning of damage due to improper power supply
Improper operation causes overvoltage in the device, which may be transmitted
to the operator.
• Ensure prior to startup that the mains supply for connecting the
secretion aspirator Allegra M30 is suitable at 100 V to 240 V AC
and a mains frequency of 50-60 Hz.
• Ensure prior to startup in UL listed markets such as the USA and Canada
that the mains supply is designed for a supply voltage of 120 V AC.
• Only use the supplied power supply unit with the secretion
aspirator Allegra M30 (type: GTM91099-6015-3.0-T2
from GlobTek Inc.).
Risk of application under conditions that are not approved
• The device is not intended to be used in medical rooms where potential
equalization is required (e.g. heart surgery).
• The device is not intended to be used in hazardous areas/in the MRI
environment.
• The device is not intended to be used outdoors/during transport.
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Health risks due to the handling of infectious or pathogenic
germs
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Infectious and pathogenic germs in the aspirate cause health risks.
• Never operate the device without bacterial filter.
• Prior to each application, make sure that the bacterial filter is dry and clean
to ensure faultless operation. Pay attention that the bacterial filter does not
get moist during the performance of cleaning/disinfection.
• Always perform the aspiration using a suitable sterile disposable catheter.
The suction tube must never come into direct contact with the aspiration
site.
• Follow the hygiene, cleaning and decontamination instructions.
Hazard of persons due to strangulation
• People may strangle themselves on the tubing or the mains cable, especially
if tubes resp. cables are unduly long.
• Ensure that no unauthorized/uninvolved persons are near the device during
aspiration.
• Store the device incl. accessories in the shipping carton until the next time
of use.
Risk of damage due to electromagnetic phenomena
Medical electrical devices are subject to special precautionary measures regard-
ing electromagnetic compatibility and must be installed and operated in accord-
ance with the EMC information provided in the accompanying documents (see
section 8).
Hazard of persons due to improper handling
• Only use the device for its intended purpose.
• Never use the device for aspiration in the low vacuum range
(e.g. thoracic drainage).
• If aspiration procedures are carried out too often, slight bleeding may occur.
• When using the device for the treatment of children, the vacuum setting
"Low" must be used.
• When using the power supply unit, ensure that it is connected to the
aspirator firstly and afterwards to the mains supply (100 V to 240 V AC).
The disconnection of the power supply unit from the mains supply must be
performed in exactly the opposite sequence (first remove the power supply
unit from the mains supply (100 V to 240 V AC) and then remove it from
the aspirator).
• Never touch parts of other devices than ME devices in the patient environ-
ment and the patient simultaneously.
Safety defects due to improper accessories and spare parts
The use of accessories and spare parts, detachable parts or materials that are
not recommended by Heinen + Löwenstein GmbH & Co. KG and specified in
the instruction for use may compromise the safety and function of the device.
Any warranty is excluded for damage caused by using accessories and spare
parts not recommended or by improper use.
• Only use original accessories and spare parts.
Warning of safety defects due to improper connections of the ME
system
The connection of the ME system with other devices or installations resp. pieces
of equipment not recommended by Heinen + Löwenstein GmbH & Co. KG
and not specified in the instruction for use may compromise the safety and
function of the ME system. Any warranty is excluded for damage caused by
connecting devices or installations resp. pieces of equipment not recommended
with the secretion aspirator Allegra M30 or by improper use.
• Only connect recommended original parts with the
secretion aspirator Allegra M30.
Damage of the device by heat
• Do not cover the power supply unit.
• Keep the aspirator as well as the mains cable and the power supply unit
away from other heat sources.
• Do not place the aspirator directly adjacent to other devices, since this can
result in heavy warming of the aspirator.
Damage of the device due to improper handling
• Never aspirate flammable, corrosive or explosive liquids or gases.
• Do not drop the device.
• Prior to each use check the housing for any damage and do not operate the
device in case of apparent housing damage.
• Prior to each use check the suction tube, secretion canister and bacterial
filter and if applicable any other accessories, that are subject to wear and
damage, to ensure that the components are in a perfect condition and
proper operation of the device is guaranteed. If this is not the case, replace
the parts immediately.
1 User information
Inspection of the internal power supply
Since the internal battery is not maintained automatically in a fully operational
state, it is necessary to check the charging status regularly and if necessary, the
battery must be replaced by service staff. The battery may only be replaced by
trained service staff, since the replacement by inadequately trained personnel
could result in a hazard (such as excessive temperatures, fire or explosion)!
Possible physiological effects and unobvious risks
• Select the vacuum range depending on the respective patient and on the
medical indication to avoid personal injuries.
• Always place the device upright on a sturdy and flat base without slope.
Make sure that the device cannot be knocked over or fall in such a way that
persons could be hit by the falling device.
• Only operate the device with inserted vacuum pump and closed lid. The lid
above the vacuum pump may only be opened by adequately trained service
staff! Likewise, the vacuum pump may only be replaced by adequately
trained service staff.
• Other devices, examinations or treatments may possibly be influenced by
the device. For this reason, special attention should always be paid to other
devices as well as to examinations and treatments performed in parallel so
that any influence is detected as quickly as possible.
• When using the device, adequate lighting must always be ensured so that all
labels can be identified clearly.
• Small, detached parts could be inhaled or ingested. Therefore ensure that
no unauthorized persons, children or pets are near the device.
• Although the materials used have been tested for compatibility, in excep-
tional cases allergic reactions to the exposed materials on the device and
its accessories may occur. This applies especially for contact injuries after
prolonged contact. In such cases, turn to a doctor immediately.
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