User Manual Revision 4.2c2 (October 2019) Translated Version: English Original version: German www.orpc.
1 General Instructions 1 2 Classification and Intended Use 2 3 3.1 3.2 3.3 3.4 Setting Up and Starting Up Connecting the Cables and Other Units Safety Instructions Electromagnetic Compatibility (EMC) Graphical Symbols 3 5 6 7 8 4 4.1 Operation Operation Panel 9 9 5 5.1 5.2 5.3 5.4 5.5 5.
www.orpc.com 1 General Instructions Congratulations on purchasing your new ACL OR-MD®. You have decided on a state-of-the-art quality product from a next-generation manufacturer. These instructions will give you a general idea of the steps you have to take for starting up and operating this display system. Please read it even if you are familiar with operating display systems.
2 Classification and Intended Use The unit is designed for displaying data such as patient information inside and outside of operating theaters, intensive-care wards and similar areas of application. It is intended to assist a signal source device without a display or as its alternative display. Following Section 6 of DIN EN 60601-1:2013 the unit is classified as below: 6.2 protective class I unit 6.
www.orpc.com 3 Setting Up and Starting Up The unit has been cleaned before leaving our production facilities. However, the units are neither sterile nor disinfected on arrival due to transport conditions and packing. Advices for initial cleaning can be found at section 5.1. Make sure that the unit and its accessories are complete with the attached delivery note.
Furthermore, it is necessary to ensure appropriate unit ventilation to protect it from overheating and for reliable and continuous operation. This is the reason why the unit should not be put in a place or under conditions where it is not possible to offer sufficient ventilation for the unit’s housing surfaces.
www.orpc.com 3.1 Connecting the Cables and other Units Only use the supplied cables. Start off by connecting the potential equalization cable (special greenish-yellow marking) to ensure a sufficient potential equalization between the unit and the user. The unit should not be operated in medical areas without connecting up potential equalization. Check to see whether your power grid has the correct voltage and frequency before connecting the unit to the mains (refer to the nameplate on the housing).
3.2 Safety Instructions Please comply with the safety instructions compiled below to prevent fire, electrical shocks, injuries and damage to the unit. Protect the unit from exposure to strong infrared radiation like i.e. direct impact of sunlight. Protect the unit from strong magnetic fields like the field close to a MRI. Protect the unit from exposure to strong electromagnetic radiation.
www.orpc.com 3.3 Electromagnetic Compatibility (EMC) Emissions Test Compliance Level RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Class B Class D Electromagnetic Environment - Guidance The unit uses RF energy only for is internal function. Therefore, is RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The unit is suitable for other use than in domestic establishments.
3.4 Graphical Symbols The signs and symbols below may have been used on your unit depending upon the equipment furnished on your product: Symbol Meaning CE symbol E500364 and 8 Source 2006/95/EG Annex III or 93/42/EWG Annex XII MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 und A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO.
www.orpc.com 4 Operation You can use the Standby button to turn the unit on and off. This does not disconnect the power supply from the mains though. Your unit is equipped with a capacitive operating panel. You can simply touch the glass pane above the symbol to trigger the key. To prevent the panel from trigger events during wipe disinfection you need to hold your finger on a key for at least 0.3. 4.1 Operating Panel The unit operates with the operating panel on the front.
5 5.1 Servicing Tips for Care and Hygiene The unit cannot be sterilized. All kind of wipe disinfectants that are listed below can be used for cleaning the unit. The original list with all active substances and product names is available on the Website of the “Robert Koch-Institut “with the title “Liste der vom Robert Koch-Institut geprüften und anerkannten Desinfektionsmittel und –verfahren“ (source: Bundesgesundheitsblatt 12/2013) or from ACL in German.
www.orpc.com 5.2 Maintenance Intervals and Wear Parts All units are designed for 24/7-operation. This is resulting in highest requirements to components and materials. To ensure the reliable operation under these harsh conditions we recommend to replace the following components prophylactically: Component Panel Exchange After Note 30.
5.4 Repairs Diligent testing of the unit is guaranteed by the manufacturer. He is responsible for safety-related characteristics within the legal limits only if repairs and modifications are performed by personnel authorized and trained or supervised by ACL and if the unit and its accessory are used according to the rules of the intended use. Therefore, there are warranty seals on or in your unit. Once a seal is broken an expiring warranty has to be assumed.
www.orpc.com 5.5 Instructions for Transporting ACL Units Please use ACL transport systems only to avoid any damages due to transportation conditions. If you need an appropriate transport system, we can send you all required materials for your unit at net costs. Components might be damaged if improper transport systems are used. Therefore, please take care of a careful handling during loading and transporting processes.
5.6 Environmentally Correct Disposal This section applies for returning old electrical and electronic equipment in the countries of the European Union. Users of electrical and electronic equipment are obliged to collect old equipment separately.
www.orpc.com 6 Getting in Contact with the Manufacturer You can get in touch with us at the following address: ACL GmbH Apelsteinallee 5 04416 Markkleeberg Germany phone: fax: +49 (341) 23078 - 0 +49 (341) 23078 - 99 8 a.m. to 5 p.m. Monday-Friday email: service@acl.de website: www.orpc.
8 Warranty and Guarantee Thank you for purchasing a quality product from ACL GmbH. We have developed our products to meet high technical and quality standards. To maintain this quality, there are some assurances that you as a customer are entitled to claim in the event of material or processing faults in the product you have purchased. We will use the terms guarantee, warranty and service to describe the differences between those assurances.
www.orpc.com 8.2 The Guarantee Finally, there is the possibility of purchasing services from ACL GmbH and its sales partners for an additional price to expand the scope and term of the guarantee. These are the available types of guarantee: bring-in guarantee The customer brings the defective unit to a qualified ACL service point in consultation with ACL GmbH.
8.3 Scope of and Performing Services In the absence of other regulations, the service includes all material and processing faults occurring for the specific term of the guarantee. Maintained services neither extend the guarantee nor warranty period, nor do they set a new period in motion. The period for installed replacement parts ends with the guarantee or warranty period for the entire unit.
www.orpc.com 2 - Phone Please contact us at the phone number from section 6.
Furthermore, the service does not include diagnosing and rectifying malfunctions caused by: - customers or third parties using or handling the unit improperly or inexpediently (such as screen breakage, damage to the mechanism or housing and defective cables or plugs) - damage during shipment, if the device was sent back to ACL by the customer ignoring the transport instructions like i.e. indicated in section 5.
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ACL GmbH Apelsteinallee 5, 04416 Markkleeberg, Germany Phone +49 341 230 78-0 Fax +49 341 230 78-99 Email info@acl.de Website www.orpc.com No reproducing in any form of this manual, in whole or in part, may be made without written authorization from ACL GmbH. All rights reserved. © 10/2019 Subject to change without notice. www.orpc.