ASSKEA ped M and ASSKEA ped S
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Instructions for Use ASSKEA ped M and ASSKEA ped S MEDICAL — GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012); CAN/CSA C22.2 No. 60601-1:14; IEC 60601-1-6 (2010) + AMD1(2013); CAN/CSA-C22.2 No. 60601-1-6:11+ Am1: 2015; ANSI/AAMI/IEC 60601-1- 8 (2006) + Am.1 (2012); CAN/CSA-C22.2 No. 60601-1-8:08 + Am1:14

Copyright © 2021 ASSKEA GmbH, Gebesee. The safety of the ASSKEA ped M and the ASSKEA ped S complies with the acknowledged rules of technology and meets the requirements of the German Medical Devices Act. The ASSKEA ped M and the ASSKEA ped S devices bear the CE marking CE0494 in accordance with EU Council Directive 93/42/EEC concerning medical devices and meet the essential requirements of Annex I of this directive, as well as with Article 120 of Regulation (EU) 2017/745 of the European Parliament and of the Council. The ASSKEA ped M and the ASSKEA ped S have been tested in accordance with...

Notes on delivery damage and customer feedback Caution! Please, check consignments for damage immediately upon delivery and remove any packaging. All damages must be reported within three days. Otherwise they cannot be accepted. The products described in this instruction for use are subjects to constant development and improvement. For this reason, we welcome all customer feedback, comments and suggestions regarding our products and their instruction for use, which contribute to improving the product, service or documentation. Contact: mps@asskea.de

User information Using these instructions for use Please read these instructions for use carefully before operating the ASSKEA ped M or the ASSKEA ped S devices for the first time. Please read the safety instructions (Section 2.6) to avoid hazards. These instructions for use are a component of the ASSKEA ped M or the ASSKEA ped S. Keep these instructions for use in an easily accessible place. Include these instructions for use when passing the ASSKEA ped M or the ASSKEA ped S device on to third parties. Device, packaging and accessories Caution: possible bodily injury, health risks or...

Meaning Battery full Battery low Battery empty Up Down OK (On, Enter) Cancel (Off, Back) Power supply unit is connected Filter run time elapsed; replacement of internal filter by service personnel is required! Symbol convention Bulleted list Perform the process in the specified sequence.

Abbreviation for “approximately” Aspirate is the generic term for secretions, bodily fluids and flushing liquids that are typically accumulated during aspiration of the upper airways. These can be aspirated easily using the device described here. Contamination means that bacteria and viruses from the aspirate have come into contact with the interior of the device. Double filter system (only ASSKEA ped S) An external filter and an internal bacterial filter into the aspirator make up the double filter system. The double filter system effectively protects the interior of the device from...

with the aspirate must be cleaned, disinfected and replaced, if necessary. Processing may only be performed by ASSKEA GmbH or by a service partner authorized by ASSKEA GmbH. The ASSKEA ped M and the ASSKEA ped S are network-independent mobile medical aspirators for temporary and primarily spontaneous aspiration of aspirate from the trachea. The ASSKEA ped M and the ASSKEA ped S are especially designed for secretion aspiration in children and can be used in outpatient and inpatient care (professional healthcare facility environment). Essential functions • Generation of a vacuum (medium...

Basic safety instructions – CAUTION! Risk 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 ped M or the ASSKEA ped S is suitable for 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 to operate at a supply voltage of 120 V AC. • Only use the power supply unit supplied with the ASSKEA ped M or the ASSKEA ped S (see section 8)....

Damage to the device caused by heat • Do not cover the power supply unit. • Keep the aspirators, the mains cable and the power supply unit away from other heat sources. Damage to 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 the event of apparent housing damage. • Prior to each use, check all components that are subject to wear and damage, to ensure that these are in a perfect condition and proper operation of the devices...

User requirements The ASSKEA ped M and the ASSKEA ped S may only be operated and used by instructed and appropriately trained personnel. Familiarize yourself with the mode of operation of the ASSKEA ped M or the ASSKEA ped S prior to startup. Training on how to handle the ASSKEA ped M or the ASSKEA ped S is provided by ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH. Product training includes an explanation of the design and function of the device, the handling of the device, the cleaning and disinfection as well as the procedure to be followed for each new patient and for...

Product description Overall view of the ME system Disposable secretion canister with integrated suction tube Canister locking mechanism (Up) and (Down) arrow buttons ASSEKA ped M device Socket for power supply unit ASSKEA ped S with disposable secretion canister system A B C D E External canister “Bag” and and disposable liner “OneWay” (1 l) Holder for external canister “Bag” Connecting tube Display Control panel ( (Up) and (Down) arrow buttons) ASSEKA ped S device Socket for power supply unit