Product Description; Whole View Of The Me System; Product Contents; Product Properties - Lowenstein Medical Allegra M30 Mode D'emploi

2 Product description

2.1 Whole view of the ME system

I
H
A
B
C
D
EN
E
F
Fig. 1
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A Secretion canister (reusable) with integrated
overflow protection in the lid (fig. 19)
B Control panel
C On/off button
D Socket for power supply unit (12V DC)
E Power supply unit (GlobTek GTM91099-6015-3.0-T2)
F Mains cable
G Suction tube
H Lid vacuum pump
I Carrying handle

2.2 Product contents

• the secretion aspirator Allegra M30
• the instruction for use of the secretion aspirator Allegra M30
• the power supply unit GlobTek GTM91099-6015-3.0-T2
• reusable secretion canister system (incl. suction tube and fingertip)
• rinsing bottle, reusable (250 ml)
• charging instructions, multilingual
• safety instruction for handling battery packs
• "Used Medical Device" label and decontamination certificate
• test report in accordance with IEC 62353
• optional accessories (depending on the order)

2.3 Product properties

G
Hazards 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).
Damage to the device due to improper handling
• Never aspirate flammable, corrosive or explosive liquids or gases.
• Do not drop the device.
• Do not operate the device in case of apparent housing damage.
The secretion aspirator Allegra M30 is an especially handy, battery
powered medical aspiration device for mobile use.
The secretion aspirator Allegra M30 has a flow rate of max.
30 l/min ± 2 l/min (see section 7 "Technical data").
The secretion aspirator Allegra M30 is operated via the internal bat-
tery or via the supplied power supply unit that can also be used to recharge the
battery. A rotary vane pump generates the desired vacuum.
After 5 minutes of operation, the device switches off automatically to prevent
overheating. The device should be left switched off for at least 5 minutes to
ensure sufficient cooling of the device. However, the device can be switched on
again immediately in emergency situations.
Moreover an overheating protection prevents the battery from overheating by
interrupting the charging process if the temperature of the battery is too high
(e.g. due to unfavorable environmental conditions).
After it is switched on, the vacuum pump generates a vacuum in the secretion
canister, which is used to aspirate secretion (via a suitable sterile aspiration set).
The aspirate is directed away from the patient and collected in the secretion
canister. If the secretion canister is full, the aspiration is stopped by means of a
mechanical overflow protection integrated into the lid of the secretion canister.
The desired vacuum is set by buttons in the control panel (fig. 1(B), see section
1.2.2)). The secretion canister is attached by sliding it directly into the housing
structure of the aspirator (fig. 8, 9). This also establishes the vacuum connection
between the aspirator and secretion canister.
The device is charged or operated via the supplied 12V power supply unit
(fig. 1(E)).
2 Product description

2.4 Information on the bacterial filter

Health risks due to the handling of infectious or
pathogenic germs
Infectious and pathogenic microbes in the suction material can pose a
risk to health.
• 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.
The bacterial filter integrated between the vacuum pump and the secretion
canister consists of a hydrophilic (self-sealing) material and has an efficiency of
99 % against bacteria and viruses. Thus it effectively protects the vacuum pump
against overflow and contamination and enables fast, simple and cost-effective
processing.
The integrated bacterial filter is only intended for use on one
patient. It must therefore be replaced by the operator each time a new
patient uses the device (see section 3.2.1). If the device is used on one patient
exclusively, the bacterial filter must be replaced at least every 2 weeks.
To ensure consistent performance, the integrated bacterial filter must also be
replaced by authorized service staff if it has come into contact with the
aspirate (blocked) or during maintenance/repair.
Since the drive unit is mechanically isolated from the vacuum pump,
it cannot become contaminated during use independent from the
bacterial filter.
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