*mymedicalexpo

Catalogs
ASSKEA
ASSKEA ped M and ASSKEA ped S

ASSKEA ped M and ASSKEA ped S

Product catalog summary

Overview: This document provides comprehensive instructions and specifications for the ASSKEA ped M and ASSKEA ped S medical aspirators, emphasizing safety standards against electrical shock, fire, and mechanical hazards. It adheres to international standards such as ANSI/AAMI ES60601-1 and IEC 60601-1-6.

Compliance and Certification: The devices comply with the German Medical Devices Act, bear the CE marking per EU Council Directive 93/42/EEC, are classified as class IIa medical devices, and have been tested according to IEC 62353.

Contents Overview: The document is organized into sections including delivery notes, user information, product description, operation, maintenance, troubleshooting, transport, storage, disposal, technical data, electromagnetic compatibility, and order information.

Key Sections:

Notes on Delivery Damage: Users should inspect for damage upon delivery and report within three days.
User Information: Emphasizes reading safety guidelines and keeping the manual accessible, with explanations of symbols and icons.
Product Description: Details components and features of the ASSKEA ped M and S, including canister systems and filter information.
Operation: Provides setup, startup, and operational instructions, including canister replacement and patient mode.
Maintenance: Covers cleaning, disinfection, and disposal procedures for various components.
Troubleshooting: Includes a function test and error message guide.
Technical Data: Lists specifications for both ASSKEA ped M and S models.

Critical Information: The document stresses the importance of following safety instructions to avoid hazards and provides detailed guidance on the proper use and maintenance of the devices to ensure safety and functionality.

Specifications and Purpose: The ASSKEA ped M and ASSKEA ped S are mobile medical aspirators designed for temporary aspiration from the trachea, specifically for children, suitable for both outpatient and inpatient care. They generate a medium vacuum and low volumetric flow, with the suction tube classified as an applied part of type BF.

Indications and Contraindications: Indicated for tracheostomy patients and aspiration in cases of impaired respiratory function. Contraindicated for liposuction, gynecology, dental applications, thoracic drainage, continuous drainage, and pharyngeal aspiration.

Safety Instructions: Users must ensure the correct power supply and use only the supplied power unit. Devices should not be used near water or in explosive environments. Proper hygiene and handling procedures must be followed to prevent health risks from infectious germs. Only recommended accessories and spare parts should be used.

User Requirements and Liability: Only trained personnel should operate these devices. Training is provided by ASSKEA GmbH and should be repeated every 24 months. Liability for device function transfers to the operator if the device is used outside its intended purpose or if unauthorized modifications are made.

Product Description: The ASSKEA ped M and ped S are lightweight, portable aspirators with a maximum flow rate of 8 l/min, operating via an internal battery or a power supply unit. The devices feature a vacuum pump that aspirates fluids into a secretion canister. The ped M uses a disposable canister, while the ped S can use both disposable and reusable systems.

Disposable Secretion Canister: Includes a suction tube, bacterial filter, carbon filter, and solidifier. Designed for single use and must be replaced when full or after each patient. Integrated filters prevent overflow and reduce odor spread.

ASSKEA Filter System Overview: The ASSKEA ped M filter system includes an external bacterial filter in the disposable secretion canister and an internal self-sealing bacterial filter within the device, effectively protecting against bacteria and viruses.

Service Life and Replacement: The internal filter is not reusable and must be replaced after contact with aspirate, when the service life expires, or during maintenance. Replacement should be performed by ASSKEA GmbH or an authorized partner.

Carbon Filter Information: An additional carbon filter in the exhaust air vent neutralizes odors. It should be replaced every two years or during maintenance.

Secretion Canister Systems: Disposable System: Includes a canister, liner with integrated filters, and tubes. Reusable System: Comprises a canister with overflow protection and an external bacterial filter.

Double Filter System for ASSKEA ped S: The DFS® system includes external bacterial filters in both the disposable liner and reusable canister, providing effective protection against contamination.

Battery Information: The battery charge level is displayed, and it should be fully charged before first use and periodically thereafter. The battery is protected against deep discharging and overheating.

Pressure Settings: Pressure can be adjusted between -60 mbar and -350 mbar by healthcare professionals. Always use the lowest effective pressure setting.

Warranty: The devices have a two-year warranty, with six months for the battery. Warranty is void if unauthorized modifications or repairs are made.

Operation and Safety: Only trained personnel should operate the devices. Regular maintenance and proper handling are crucial to prevent malfunctions and ensure safety.

Setup and Startup: Ensure all components are undamaged before use. The device should be placed on a stable surface, and the battery should be fully charged before initial startup. Proper connection of the secretion canister and tubing is essential for operation.

Device Setup and Operation: Detailed instructions for setting up and operating the ASSKEA ped M and ASSKEA ped S devices are provided. Key steps include attaching the secretion canister, connecting tubes, and setting the vacuum value.

Patient Mode: Allows viewing and resetting patient runtime. Access requires an authorization code, provided to trained personnel only.

Canister Replacement: Instructions for replacing disposable canisters and liners are provided, emphasizing proper disposal and connection to ensure device functionality.

Decommissioning: Steps for safely decommissioning the device include switching off, disconnecting power, removing canisters, and cleaning components.

Maintenance and Cleaning: Involves regular cleaning and disinfection to prevent health risks from infectious germs. Specific cleaning agents are recommended, and the document warns against using acetone-based products.

Troubleshooting: Includes a troubleshooting section for common issues such as device startup problems and aspiration failures.

Safety and Hygiene: Emphasis is placed on wearing protective clothing during maintenance and handling components that contact aspirate.

Error Handling: Outlines various error messages and their remedies, such as replacing canisters or filters and checking for tube kinks.

Transport and Storage: Devices must be cleaned and disinfected before shipping. Batteries should be charged before storage.

Technical Specifications: Both devices have a maximum flow rate of 8 l/min and a vacuum range of -60 to -350 mbar. They operate on AC 100-240 V and have a rechargeable battery with a runtime of approximately 18 hours for the ped M and 10-20 hours for the ped S.

Electromagnetic Compatibility: The devices comply with EN 60601-1-2:2015 standards.

Order Information: Lists item numbers and descriptions for various components and accessories.

Contact Information: ASSKEA GmbH provides contact details for further inquiries or support.

Catalog excerpts

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

Open the catalog to page 1

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 IEC...

Open the catalog to page 2

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: [email protected]

Open the catalog to page 5

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 damage...

Open the catalog to page 6

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.

Open the catalog to page 7

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 contamination...

Open the catalog to page 8

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 vacuum)...

Open the catalog to page 9

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). Health...

Open the catalog to page 10

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 is...

Open the catalog to page 11

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 disposal....

Open the catalog to page 12

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

Open the catalog to page 13

All ASSKEA catalogs and technical brochures

procuff® Series
50 Pages