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ASSKEA
procuff® Series

procuff® Series

Product catalog summary

Overview: This document provides comprehensive instructions for the ASSKEA procuff® M and S medical suction devices, focusing on safety, operation, maintenance, and compliance with international standards.

Specifications and Compliance: The devices comply with ANSI/AAMI ES60601-1, CAN/CSA C22.2, IEC 60601-1-6, and other relevant standards, ensuring protection against electrical shock, fire, and mechanical hazards. They are classified as class IIa medical devices under EU Council Directive 93/42/EEC.

Safety and Usage Instructions: Users must read the instructions carefully before use. The devices are intended for operation by trained medical professionals and trained relatives of patients. Adhering to safety instructions is crucial to avoid hazards.

Product Description: The document details the components and features of the ASSKEA procuff® M and S, including disposable secretion canisters, filter systems, and battery information. It also outlines the scope of delivery for each model.

Operation: Instructions for setup, startup, and operation are provided, including connecting canisters and setting pressure levels. The document also covers patient mode and canister replacement procedures.

Maintenance: Guidelines for cleaning, disinfection, and disposal of components are included, with specific instructions for outpatient, inpatient, and homecare settings. Regular maintenance and servicing are emphasized to ensure device longevity.

Troubleshooting: A section is dedicated to troubleshooting, including function tests and error messages, to assist users in resolving common issues.

Technical Data and EMC Information: Technical specifications for both models are provided, along with information on electromagnetic compatibility and handling of electromagnetic interactions.

Order and Contact Information: The document concludes with order information for the devices and contact details for customer feedback and support.

Protection Class and Safety Instructions: The device is classified as Type BF (Body Floating) and should not be used if the packaging is damaged. It has a temperature limitation and is not reusable. It must not be disposed of in domestic waste.

Display Symbols: The display includes symbols indicating battery status, power connection, run time, pause time, and filter replacement needs. It also shows alarm status.

Glossary: Key terms include aspirate, contamination, and DFS (Double Filter System) which protects the device from contamination.

Intended Use and Functions: The ASSKEA procuff® M and S are mobile medical devices for subglottic aspiration in healthcare and homecare settings. They generate a medium vacuum and low volumetric flow. They are contraindicated for liposuction, gynecology, dental applications, and more.

Safety Instructions: Ensure proper power supply and use only the supplied power unit. The device is not for outdoor use or in explosive/MRI environments. Follow hygiene protocols to avoid health risks from infectious germs. Avoid improper handling to prevent damage or safety risks.

User Requirements: Only trained personnel should operate the devices. Training is provided by ASSKEA GmbH and should be repeated every 24 months.

Product Description: The ASSKEA procuff® M includes a disposable secretion canister, locking mechanism, display, and power socket. The ASSKEA procuff® S has a larger canister system and similar features.

Scope of Delivery: The delivery includes the device, instructions, disposable canisters, power supply unit, and various documentation and labels.

Product Properties: The ASSKEA procuff® M and S are portable, battery-powered medical aspirators designed for medium-vacuum range aspiration in medical settings, including hospitals and homecare. They feature a max flow rate of 8 l/min and are equipped with a maintenance-free electric motor-driven diaphragm pump. The devices include safety mechanisms to prevent overheating and overflow.

Disposable Secretion Canister System: The system includes a canister with a suction tube, integrated bacterial and carbon filters, and a solidifier to manage aspirate. The canister is intended for single use and must be replaced when full or weekly, following hygiene instructions.

Filter Systems: The ASSKEA procuff® M features an internal and external bacterial filter system to prevent contamination and overflow. The ASSKEA procuff® S uses a double filter system (DFS®) for similar protection. Filters are not reusable and must be replaced by authorized personnel.

Battery Information: The devices use lithium-ion batteries with a low self-discharge rate. Regular checks and proper charging are necessary to maintain battery health. The battery is protected against deep discharging and overheating.

Pressure Settings: Pressure can be adjusted between -60 mbar to -300 mbar by healthcare professionals. The lowest possible pressure setting should be used.

Warranty: The devices have a 2-year warranty, while the battery is covered for 6 months. Warranty claims are void if unauthorized modifications or repairs are made.

Operation: Proper handling is crucial to avoid risks. The device should be used as intended, and regular replacement of the secretion canister is necessary to prevent malfunctions. Training and monitoring by healthcare professionals are recommended, especially in homecare settings.

Setup and Startup: Instructions for connecting the device to the power supply are provided. The device should not be used in damp environments, and care should be taken to avoid damage during setup.

Device Maintenance and Cleaning Procedures: The document outlines the maintenance and cleaning procedures for the ASSKEA procuff® M and S devices, emphasizing the importance of hygiene to prevent health risks from infectious germs. It highlights the necessity of wearing disposable gloves and using single-use canisters and liners for each patient.

Cleaning and Disinfection: Regular cleaning and disinfection of the device surfaces are required, with specific instructions for different components such as the external canister "Bag" and tubing accessories. The document advises against using acetone-based disinfectants and recommends specific products for disinfection.

Disposal Procedures: Detailed steps are provided for the proper disposal of disposable secretion canisters and liners, ensuring compliance with hygiene standards.

Homecare Sector: Similar cleaning and disposal procedures are outlined for homecare settings, with additional instructions for handling disinfectants and maintaining device hygiene.

Further Use and Maintenance: The document stresses the importance of professional processing before passing the device to other patients. It warns against unauthorized modifications and emphasizes that maintenance should only be performed by authorized personnel.

Troubleshooting: A section is dedicated to troubleshooting common device malfunctions, providing probable causes and remedies for issues such as device startup failures and therapy interruptions.

Error Messages and Troubleshooting: The document outlines various error messages for the ASSKEA procuff® M and S devices, detailing the status, probable causes, and remedies for each. High-priority alarms are indicated with a red flashing background and a specific beeper pattern, while low-priority alarms have a static yellow background with periodic beeping. Common issues include full secretion canisters, empty batteries, internal errors, and blocked cannulas or tubes. Users are advised to replace canisters, connect power supplies, or contact service partners if issues persist.

Transport, Storage, and Disposal: Before transferring devices to new users, they must be decontaminated according to German regulations. ASSKEA GmbH provides processing and testing services. Devices should be stored in their shipping cartons, with batteries charged to ensure readiness. Disposal must comply with EU directives, and devices should not be discarded with domestic waste. They can be returned to ASSKEA GmbH or disposed of at designated facilities.

Technical Data: The document provides detailed specifications for the ASSKEA procuff® M and S, including flow rates, vacuum levels, power requirements, and environmental conditions for operation and storage. Both devices have a continuous operation time of approximately 18 hours on battery power and an expected service life of 5 years.

Electromagnetic Compatibility (EMC): The devices meet IEC 60601-1-2 standards for electromagnetic compatibility. Users are warned against using the devices near other electronic equipment to avoid interference. Only original ASSKEA accessories should be used to maintain electromagnetic immunity.

Handling Electromagnetic Interactions: Users should monitor the devices for electromagnetic disturbances and ensure they operate in a suitable environment. If interference is detected, relocating the device may be necessary.

Order Information: The document lists item numbers and descriptions for ordering components and accessories for both the ASSKEA procuff® M and S devices.

Catalog excerpts

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

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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 compliance...

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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: [email protected]

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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 ([email protected])....

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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.

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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 enables...

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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 vacuum...

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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 S...

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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 canister,...

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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 any...

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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 procedure...

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