Infinity Vista XL Instructions for Use

1 I n f i n i t y M o d u l a r M o n i t o r i n g S e r i e sInfinity Vista XL Instructions for UseWARNING: For a full understanding of the performance characteristics of this device, the user should carefully read this manual before use of the by: Draeger Medical Systems, Inc. 3135 Quarry Road Telford, PA 18969 Infinity Vista XL Instructions for Use Software VF7 Draeger Medical Systems, Inc. 2007. All rights in the United States of device bears the H label in accordance with the provisions of the Directive 93/42/EEC of 14 June 1993 concerning medical devices (this label is not applicable for US devices).Distributed By: Dr ger Medical AG & Co. KG Moislinger Allee 53-55 D-23558 L beck GermanyDr ger reserves the right to modify the design and specifications contained herein without prior notice.

2 Please contact your local Dr ger Sales Representative for the most current in any manner, in whole or in part, in English or in any other languages, except for brief excerpts in reviews and scientific papers, is prohibited without prior written permission of Dr ger Medical AG & Co. Dr ger devices are intended for use by trained medical personnel using any Dr ger devices, carefully read all the manuals that are provided with your device. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can , MultiMed, Cardiology Review Station, Scio, and OxiSure are registered trademarks of Dr ger Medical AG & Co. is a registered trademark of Novametrix Medical Systems, , Masimo SET and Signal Extraction Technology (SET) are registered trademarks of Masimo SOFTWARE 1989, 90, 91, 92, 93, 94 Microtec Research Inc.

3 All rights reservedSome graphics courtesy of Novametrix Medical Systems, rights reserved under the copyright laws of the United StatesRESTRICTED RIGHTS LEGEND Use duplication or disclosure by the Government is subject to restrictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data & Computer Software clause at DFARS 252 227:7013 MICROTEC RESEARCH INC. 2350 MISSION COLLEGE BLVD. SANTA CLARA CA 95054 Microstream is a registered trademark of Oridion Medical 1987 other brand or product names are trademarks or registered trademarks of their respective device is subject to EU Directive 2002/96/EC (WEEE). It is not registered for use in private households, and may not be disposed of at municipal collection points for waste electrical and electronic equipment.

4 Dr ger Medical has authorized a firm to dispose of this device in the proper manner. For more detailed information, please contact your local Dr ger Medical :In the United States, Federal Law restricts these devices to sale by, or on order of a IIII ntended Use ..IVIndications For Use ..VDocumentation Features ..VINotes, Cautions, Warnings .. Reference Tables ..VIFooter .. of Operation ..VIII nspection and Maintenance ..VIIG eneral Electrical Safety ..IXPacemakers ..IXPeripheral Devices .. Compatibility ..XITable of Contents ..XIIIVVISTA XLVF7 Infinity Vista XL USER S GUIDEI ntended UseThe Infinity Vista XL monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits, and timed or alarm recordings will be produced.

5 These devices will connect to R50 recorders either directly or via the Infinity Vista XL USER S GUIDE VF7 Vista XLVI ndications For UseThe Infinity Vista XL monitors are capable of monitoring:zHeart ratezRespiration ratezInvasive pressurezNoninvasive pressurezArrhythmiazTemperaturezCardiac OutputzArterial oxygen saturationzPulse ratezApneazST Segment Analysisz12-Lead ST Segment AnalysiszFiO2 The devices are intended for use in the environment where patient care is provided by Healthcare Professionals, Physicians, Nurses, and Technicians who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The devices are intended to be used on Adult, Pediatric and Neonatal populations with the exception of the parameter cardiac output, ST-segment analysis, and arrhythmia which are intended for use in the adult and pediatric populations only.

6 The Infinity Modular Monitors are not compatible for use in a MRI magnetic XLVF7 Infinity Vista XL USER S GUIDED ocumentation FeaturesWarnings, Cautions, Notes Cross-referencesCross-references specify chapter and page ( , page 16-3 refers to Chapter 16, page 3). Chapter number and title are given when text refers to an entire chapter ( , Chapter 1, Introduction). Quick Reference TablesWherever possible, a quick reference table is provided for easy access to information about monitor functions. FooterThe current software version appears at the bottom of each page, together with the chapter and page number and the device references to the monitor in this manual refer to the Vista XL patient monitor. WARNING! A warning statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious !

7 A caution statement provides important information about a potentially hazardous situation which, if not avoided may result in minor or moderate injury to the user or patient, or in damage to the equipment or other :A note provides additional information intended to avoid inconvenience during Vista XL USER S GUIDE VF7 Vista XLVIIS afety ConsiderationsThis Instructions for Use assumes a working knowledge of patient monitors. To support proper, safe and accurate operation of equipment, read all operating Instructions carefully before you use the monitor. The monitor complies with IEC 60601-1 and applicable collateral and particular of Operation Inspection and MaintenanceRegular equipment inspection and maintenance is required. The user should verify that the monitor operates as described in this manual and that all safety labels are legible and should also maintain a record of these and other inspections.

8 Safety checks, verification, calibration and maintenance should be performed at least every two years by trained personnel, as described in the Service Manual (see individual WARNING:zConnect the AC Adapter to hospital grade electrical outlets with medical power operation is not currently supported in the following environments: magnetic resonance imaging (MRI) environments, aircraft, ambulance, home or hyperbaric chamber not operate the monitor or its remote displays in the presence of flammable not use the monitor near devices with microwave or other high-frequency emissions. These emissions may interfere with the monitor s the monitor and accessories with at least 2 in. (5 cm.) of space around all sides to prevent not allow fluids to come in contact with monitor or peripherals.)

9 If fluids are accidentally spilled on equipment, remove affected unit from service as soon as possible. Contact your biomed to ensure that there is no compromise in electrical :zThe site of operation must meet the environmental requirements outlined in Appendix B, Technical avoid patient injury, ensure patient is disconnected from all sensors, etc. before moving XLVF7 Infinity Vista XL USER S GUIDE parameter chapters for information about calibration and verification of parameter-specific functions and devices). All cables, alarm functions, accessories, and associated devices should be checked for damage, ground resistance, chassis and patient leakage currents on a yearly basis, or more frequently, based on usage. Dr ger Medical recommends:zMaintenance, modifications, and repairs are carried out by trained are replaced with Dr ger Medical provided spare parts, otherwise the correct functioning of the device may be are used in accordance with Dr ger Medical operating Instructions , as described in this Instructions for :zDisposable accessories (such as disposable electrodes, transducers, etc.

10 Are for single use only. Do not reuse disposable not use cables that appear cracked, worn, or damaged in any way. Such use may contribute to poor monitoring performance or the display of erroneous under the front panel can damage the electric circuits and compromise key function. Read carefully cleaning Instructions on page of the danger of electric shock, never remove the cover of any device while it is in operation or connected to a power :zThe monitor s Service Manual is available from your local Dr ger Medical service of all equipment in accordance with local regulations. Infinity Vista XL USER S GUIDE VF7 Vista XLIXG eneral Electrical SafetyPacemakersPeripheral Devices ElectrosurgeryCAUTION:zEnsure electrical shock classifications for all equipment connected to the patient are suitable for the intended application.