Related Manuals for Dräger Infinity Acute Care System
Summary of Contents for Dräger Infinity Acute Care System
- Page 1 Instructions for use ® Infinity Acute Care System ® Infinity Medical Cockpits WARNING To properly use this medical device, read and comply with these instruc- tions for use.
- Page 2 Typographical conventions Illustrations Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each Illustrations of products and screen content in this new sequence of actions. document may differ from the actual products Bullet points indicate individual actions or differ- depending on configuration and design.
- Page 3 Safety information defintions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important infor- mation about a potentially hazardous situation which, if not avoided, may result in minor or mod- erate injury to the user or patient or in damage to the medical device or other property.
- Page 4 This page intentionally left blank Instructions for use - Infinity ® Acute Care System - Infinity ® Medical Cockpits...
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Page 5: Table Of Contents
Contents Contents For your safety and that of your patients. . . Disposing of the medical device ... 48 General safety information ....Technical Data . - Page 6 This page intentionally left blank Instructions for use - Infinity ® Acute Care System - Infinity ® Medical Cockpits...
- Page 7 For your safety and that of your patients For your safety and that of your patients General safety information ....Strictly follow these instructions for use ..Maintenance .
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Page 8: For Your Safety And That Of Your Patients
For your safety and that of your patients General safety information Maintenance The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING WARNING and CAUTION statements specific to Risk of medical device failure and of patient subsystems or particular features of the medical injury device appear in the respective sections of these... -
Page 9: Not For Use In Areas Of Explosion Hazard Or Oxygen-Enriched Atmospheres
Strictly follow the assembly instructions and Connection to IT network instructions for use. The Infinity Acute Care System - The medical device has interfaces to connect to Infinity Medical Cockpits have no essential other devices or components. These interfaces are performance as defined in IEC 60601-1. -
Page 10: Storing The Instructions For Use
For your safety and that of your patients Any essential performance in combination with an WARNING application using the Infinity Medical Cockpits is Risk due to electromagnetic disturbance listed in the accompanying user documentation of that application. Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical Storing the instructions for use... - Page 11 For your safety and that of your patients WARNING WARNING Risk of electric shock Because of the risk of electric shock, never remove the cover of a device while it is in Do not connect connectors with an operation or connected to a mains power ESD warning symbol and do not socket.
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Page 12: Service
For your safety and that of your patients WARNING CAUTION USB equipment must be non-touchable by the The device should only be operated in surround- patient because of possible touch currents ings that meet the environmental operating tem- flowing between the Cockpit housing and the peratures specified on page 51. -
Page 13: Duties Of The Operating Organization
For your safety and that of your patients Service personnel Task Requirement Duties of the operating organization Installation Specialist knowledge in electrical engineering and Basic service work mechanics The tasks described in this document specify the (inspection, mainte- requirements that have to be met by each nance according to Experience in the servicing respective target group. - Page 14 This page intentionally left blank Instructions for use - Infinity ® Acute Care System - Infinity ® Medical Cockpits...
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Page 15: Application
Application Application Intended use ......16 Environment of use ....16 Instructions for use - Infinity ®... -
Page 16: Intended Use
C500, and the C700 are monitoring and control Series Medical Cockpits are intended to be used in displays for the Infinity Acute Care System (IACS). environments where patient care is provided by Medical Cockpits are intended to be used to trained healthcare professionals. -
Page 17: System Overview
System overview System overview Overview ......18 Front panel ......19 Back panel. -
Page 18: Overview
The Infinity Medical Cockpits are the central user- interface and processing center for the various applications of the Infinity Acute Care System. Instructions for use - Infinity ® Acute Care System - Infinity ®... -
Page 19: Front Panel
System overview Front panel G F E D A Alarm bar (use depends on application). Lights D Ambient light sensor (use depends on applica- up during alarm conditions in the respective tion). alarm color. E Battery LED. Indicates battery status (only sup- B Audio pause key (use depends on application). -
Page 20: Back Panel
System overview Back panel A Alarm bar (use depends on application) K 1x USB 3.0 port B VESA mounting C 2x USB 2.0 port D System cable port E 3x Serial communication port RS232 (COM), isolated F Cooling vents G 2x LAN 10/100/1000 Mbps, isolated H 3x USB 2.0 port 1x USB 3.0 port J 2x DisplayPort connections... -
Page 21: Symbols
System overview Symbols Symbol Explanation Symbol Explanation Read accompanying documents for Power on/off specific safety information Battery status Non-disposable part AC power mains (only for specified AC Device part number and revision power supply) Audio pause (with optional rotary knob; Device serial number functionality depends on application) Manufacturer... -
Page 22: Abbreviations
System overview Abbreviations Abbreviation Explanation Alternating Current Direct Current Electromagnetic Compatibility Electrostatic Discharge Light-emitting Diode Radio Frequency Universal Serial Bus VESA Video Electronics Standards Association Instructions for use - Infinity ® Acute Care System - Infinity ® Medical Cockpits... -
Page 23: Hardware Features
Hardware features Hardware features Overview ......24 Alarm Bar ......24 Rotary knob. -
Page 24: Overview
Hardware features Overview The Cockpit is the main user-interface for the Infin- ity Acute Care System (IACS). This section describes the main user interface elements. For detailed information regarding the user inter- face of individual IACS modules, refer to the instructions for use of the connected module. -
Page 25: Rotary Knob
Hardware features Rotary knob The rotary knob (A) is the main navigational tool of To use the rotary knob the Infinity Medical Cockpits. 1 Select a button on the screen to select a setting. 2 Turn the rotary knob to select the desired set- ting. -
Page 26: Fixed Keys
Hardware features Fixed keys Power On/Off key Two fixed keys are located on the front access panel of the Infinity Medical Cockpits: The Power On/Off key is located in the lower left – The Audio pause key corner of the Infinity Medical Cockpits. –... -
Page 27: Leds
Hardware features LEDs Each Cockpit is equipped with several LEDs that report the device status. A Power on/off key and LED (the LED in the key lights up when the device is turned on) B AC power on/off LED - Lights up when the device is connected to AC power. -
Page 28: Mounting Solutions
Hardware features Mounting solutions Table mount (IACS monitoring The Infinity Medical Cockpits come with a wide selection of mounting solutions. All applications only) Infinity Medical Cockpits mounting solutions must be VESA (Video Electronics Standard Association) WARNING compliant. The Infinity Medical Cockpits support the VESA 75 and 100 mounting standard. -
Page 29: Operating Concept
Operating concept Operating concept User interface ......30 Layout elements ..... . . 30 Header bar . -
Page 30: User Interface
D Therapy bar (if applicable) Layout elements Infinity Acute Care System - Infinity Medical Cock- F System data field – battery symbol and status pits share similar layout elements which are indicator, clock described in the following sections. -
Page 31: Monitoring Area
Infinity Medical Cockpit (for a list of compatible details. devices, see the Infinity Acute Care System – Mon- itoring Applications instructions for use). Sample parameter box Waveform area... -
Page 32: It Tabs
Operating concept IT tabs The main menu bar The main menu bar (B) is located along the right IT tabs (optional depending on application) provide edge of the screen and is always visible. It consists access to remote applications such as web-based of the following elements: IT programs. -
Page 33: Dialog Windows
Operating concept Dialog windows Views A dialog window may consist of one or more setup Views are pre-configured layouts that affect the pages. To access a dialog or a setup page, select monitoring area. A View defines the size, content, the corresponding tab. -
Page 34: Colors
Operating concept Colors Colors denote alarm conditions and identify the availability of functions or settings. NOTE If the acoustic alarm signal is paused by pressing the Audio pause key (located next to the rotary knob), the parameter box no longer flashes, but the background lights up in the solid alarm color. -
Page 35: Customizing The Display
Operating concept Customizing the display Calibrating the touch screen You can control the brightness of the screen, select how to interact with the Infinity Medical Cockpit, and calibrate the touch screen. If the touch screen of the Infinity Medical Cockpit is out of alignment for any reason (even accidental decalibration), you can recalibrate it. - Page 36 This page intentionally left blank Instructions for use - Infinity ® Acute Care System - Infinity ® Medical Cockpits...
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Page 37: Reprocessing
Reprocessing Reprocessing Disassembly ......38 Observe before disassembly ....38 Information on reprocessing. -
Page 38: Disassembly
Reprocessing Disassembly Observe before disassembly 1 Switch off the device and all devices connected to it. 2 Disconnect the mains plugs. Information on reprocessing Instructions for reprocessing are based on interna- CAUTION tionally accepted guidelines, e.g., standard Risk due to faulty products ISO 17664. -
Page 39: Classifications For Reprocessing
Reprocessing Classifications for reprocessing Classification of medical devices Medical devices and their components are classi- fied according to the way they are used and the re- sulting risk. Classification Explanation Non-critical Components that come only into contact with skin that is intact Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous mem- branes or pathologically altered skin... -
Page 40: Reprocessing List
Reprocessing Reprocessing list Components Surface disin- Manual clean- Machine Steam steril- Special repro- fection with ing followed cleaning with ization cessing mea- cleaning by disinfec- thermal disin- sures tion by im- fection mersion Infinity Medical Cockpit Reprocessing procedures Validated reprocessing procedures At the time of product-specific validation, the follow- ing reprocessing procedures showed good material compatibility and effectiveness:... - Page 41 Reprocessing Class of active ingredient Surface disinfectant Manufacturer Chlorine-releasing agents Actichlor plus Ecolab BruTab 6S Brulin Clorox Professional Disinfecting Clorox Bleach Cleaner Dispatch Hospital Cleaner Disin- fectant Towels with Bleach Klorsept 17 Medentech Oxygen-releasing agents Descogen Liquid Antiseptica Descogen Liquid r.f.u. Dismozon plus Bode Chemie Dismozon pur...
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Page 42: Surface Disinfection With Cleaning
Reprocessing Surface disinfection with cleaning WARNING Risk due to penetrating liquid Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions Ensure that no liquid penetrates the device. 1 Remove soiling immediately. Use a cloth damp- ened with disinfectant to remove soiling. -
Page 43: Maintenance
Maintenance Maintenance Overview ......44 Definition of maintenance concepts ..45 Maintenance of the Cockpit. -
Page 44: Overview
Maintenance Overview This chapter describes the necessary maintenance WARNING steps to be performed by your service personnel for Risk when the housing is being opened the proper functioning of the equipment. For addi- tional guidance on how to perform the required Under the housing, there are live electrical maintenance, refer to the Technical Service Docu- components, which may cause an electric... -
Page 45: Maintenance Of The Cockpit
Maintenance CAUTION When servicing devices from Dräger, always use spare parts that are qualified to Dräger standards. Dräger cannot warrant or endorse the safe perfor- mance of third-party spare parts for use with the devices. Definition of maintenance concepts Concept Definition Maintenance Appropriate measures intended to retain the functional state of a medical de-... -
Page 46: Inspection
Maintenance Inspection Inspections must be carried out regularly according to the following guidelines and within the specified intervals. All information needed for maintenance and safety inspections are included in this docu- ment and in the accompanying documents of con- nected medical equipment. Additional guidance is given in further technical documents that can be obtained on request. -
Page 47: Disposal
Disposal Disposal Disposing of the medical device..48 Instructions for use - Infinity ® Acute Care System - Infinity ® Medical Cockpits... -
Page 48: Disposing Of The Medical Device
Disposal Disposing of the medical device At the end of its useful life, dispose of the product in accordance with the applicable legal provisions. The disposal of electrical and electronic devices is subject to special guidelines. This device must be disposed of in accordance with national regula- tions. -
Page 49: Technical Data
Technical Data Technical Data Infinity C500/C700..... . 50 Physical attributes ..... . 50 Connectors . -
Page 50: Infinity C500/C700
Technical Data Infinity C500/C700 The following table contains the technical data for the Infinity C500 and Infinity C700. Where applicable, differences in technical data are identified for each device. Otherwise, the data applies to all devices. Physical attributes Dimensions with rotary knob Infinity C500: (W x H x D) 453 x 327 x 127 mm (17.83 x 12.87 x 5.00 in) -
Page 51: Environmental Attributes
Technical Data Mode of operation Continuous Environmental attributes Humidity Operating: 5% to 95% (non-condensing) Non-operating: 5% to 95% (non-condensing) Temperature Operating: 0 °C to 40 °C (32 °F to 104 °F) Non-operating: –20 °C to 70 °C (–4 °F to 158 °F) Altitude 0 to 4000 m (13123 feet) Atmospheric pressure... -
Page 52: Emc Declaration
Technical Data EMC declaration General information The device was tested for electromagnetic compa- tibility using accessories from the list of accesso- ries. Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device. -
Page 53: Electromagnetic Environment
Electromagnetic environment Guidance and manufacturer’s declaration – electromagnetic emissions The device (Infinity Acute Care System) is intended for use in the electromagnetic environment specified below. The customer or the user of the device (Infinity Acute Care System) should assure that it is used in such an environment. -
Page 54: Electromagnetic Immunity
Electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity The device (Infinity Acute Care System) is intended for use in the electromagnetic environment specified below. The customer or the user of the device (Infinity Acute Care System) should assure that it is used in such an environment. - Page 55 If the measured field strength in the location in which the device (Infinity Acute Care System) is used exceeds the applicable RF compli- ance level above, the device (Infinity Acute Care System) should be observed to verify normal ope- ration.
- Page 56 Recommended separation distances between portable and mobile RF communications equip- ment and the device (Infinity Acute Care System) The device (Infinity Acute Care System) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user...
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Page 57: Emc Declaration
Technical Data EMC declaration General information This device was tested for electromagnetic This device may be used in the direct vicinity of compatibility using accessories from the list of other devices only if Dräger has approved this accessories. Other accessories may only be used device arrangement. -
Page 58: Recommended Separation Distances From Wireless Communication Devices
Technical Data Immunity against Test level and required electromagnetic environ- ment Magnetic fields at mains frequency 30 A/m (IEC 61000-4-8) Voltage dips and short interruptions in the supply 100 % drop, 0.5 period voltage (IEC 61000-4-11) 100 % dip, 1 period 30 % dip, 25/30 periods Voltage interruptions: 100 % drop, 5 seconds... -
Page 59: Index
Index Index Parameter boxes ....31 Therapy line ......34 Alarm bar . - Page 60 Index Third-party application tabs ....32 User ........13 User interface .
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- Page 62 These instructions for use only apply to Infinity Medical Cockpits with the Serial No.: If no Serial No. has been filled in by Dräger, these instructions for use are provided for gener- al information only and are not intended for use with any specific machine or unit.