Asskea 100739, Инструкция по эксплуатации

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1.5.5 Contraindications
The ASSKEA secretion aspirator proVisio
®
M28 is contraindicated for the following applications:

Liposuction
 Gynecology applications

Dental applications
 Thoracic drainage

Continuous drainage
 Applications in wound areas
1.5.6 Restrictions on use

In medical rooms where potential equalization is required (e.g. heart surgery)

In hazardous areas/in the MRI environment

Outdoors/during transport
Basic safety instructions - ATTENTION! 1.6
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 ASSKEA secretion aspirator
proVisio
®
M28 is suitable at 100V to 240V AC and a mains frequency of 50-60Hz.

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 120V AC.

Only use the supplied power supply unit with the ASSKEA secretion aspirator
proVisio
®
M28 (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.
Health risks due to the handling of infectious or pathogenic germs
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.
 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).