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

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 equali-
zation is required (e.g. heart surgery).
• The device is not intended to be used in hazardous areas/in the MRI environ-
ment.
• The device is intended for mobile, temporary outdoor use (in accordance with IP
protection class 22), but not for permanent outdoor location and operation.
EN
Health risks due to the handling of infectious or pathogenic germs
9 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 regarding
electromagnetic compatibility and must be installed and operated in accordance
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 environment
and the patient simultaneously.