procuff® Series
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Instructions for Use ASSKEA procuff® M and ASSKEA procuff® 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; ANSI/AAMI HA60601-1-11:15; CAN/CSA-C22.2 No. 60601-1-11:1

Copyright © 2021 ASSKEA GmbH, Gebesee. ® The safety of the ASSKEA procuff M and ASSKEA procuff S complies with the acknowledged rules of technology and meets the requirements of the German Medical Devices Act. ® ® The ASSKEA procuff M and ASSKEA procuff S 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. ® ® The ASSKEA procuff M and ASSKEA procuff S have been tested in accordance with IEC 62353. The quality management system applied by ASSKEA GmbH is certified in...

Notes on delivery damage and customer feedback Caution! Please, check consignments for damage immediately upon delivery and remove any packaging. All damages must be confirmed by the deliverer and 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 procuff M and the ® ASSKEA procuff S device for the first time. The device can be operated by both trained medical professionals and relatives of patients, providing they have also undergone appropriate training. If this is the case all functions can be used safely. If support is required for startup, operation or maintenance, please contact ASSKEA GmbH (see Section 11). Please also report unexpected operating performance or incidents to ASSKEA GmbH...

Meaning Battery full Battery low Battery empty Up Down OK (On, Enter) Cancel (Off, Back) Power supply unit is connected Run time Pause time Filter run time elapsed; replacement of internal filter by Service is required! Alarm OFF The alarm “System closed” is disabled. Symbol convention Bulleted list Perform the process in the specified sequence.

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 procuff 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 contamination and overflow. It...

The ASSKEA procuff M resp. ASSKEA procuff S device is a network-independent mobile medical device for subglottic aspiration of aspirate with a cuff cannula or a cuff tube with exhauster. Typical areas of application are:  in outpatient and inpatient care (professional healthcare facility environment),  in the homecare sector (home healthcare environment), especially for the aspiration of aspirate with a cuff cannula or a cuff tube with exhauster. ® The ASSKEA procuff M resp. ASSKEA procuff S must never be used simultaneously on more than one patient! Essential functions  Generation of a...

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 procuff M resp. ® ASSKEA procuff 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 procuff M and ® ASSKEA procuff...

Damage to the device caused by heat  Do not cover the power supply unit.  Keep the device, the mains cable and the power supply unit away from other heat sources.  Do not place the devices directly adjacent to other devices, since this can cause the devices to overheat. 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 the suction tube and secretion...

Possible physiological effects and unobvious risks  To avoid injuries to the person, select the vacuum range depending on the respective patient and the medical indication.  Always place the devices upright on a sturdy, flat, non-sloping base. Ensure that the device cannot be knocked over or fall in such a way that persons could be hit by the falling device.  Other devices, examinations or treatments may possibly be influenced by the devices. For this reason, special attention should always be paid to other devices as well as to examinations and treatments performed in parallel so that...

The ASSKEA procuff M and ASSKEA procuff S may only be operated and used by instructed and trained personnel. Familiarize yourself with the mode of ® ® operation of the ASSKEA procuff M and ASSKEA procuff S prior to startup. ® Training on how to handle the ASSKEA procuff M resp. ASSKEA procuff S is provided by ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH. Product training takes approximately one to two hours and, among other things, includes an explanation of the design and function of the device, the handling of the device, the cleaning and disinfection as well as the...