CADWELL Arc Essentia User Manual

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Essentia User Guide 100870-639 Rev 07

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Summary of Contents for CADWELL Arc Essentia

Page 2: Copyright And Disclaimer Information
Arc Apollo Plus, CadCapture, CadSchedule, StimTroller, Synopsis, Zenith, and Zenect are trademarks of Cadwell Industries, Inc. The absence of a product or service name or logo from this list does not con- stitute a waiver of Cadwell’s trademark or other intellectual property rights concerning that name or logo.
Page 4: Table Of Contents
CadLink EEG Hardware General Overview Essentia Indications for Use Arc Essentia Setup Instructions Arc Essentia Amplifier Options E1A for Private Practice E3A for Brain Health Monitoring in the ICU and Long-Term Monitoring (LTM) Connections and Power Instructions Computer, Network, IT Security...
Page 5 Essentia Electromagnetic Emission and Immunity to Electromagnetic Disturbances Essentia Cleaning Instructions Disposal of Equipment Warranty Information Electrode Catalog and eStore Customer Support and Contact Information US Customers Service Support Application Support International Customers EU Importer Remote Assistance © 2021 Cadwell Industries, Inc.
Page 6: Intent, Overview, Indications For Use
LCD monitors and all-in-one PCs are available from Cadwell. Two versions of the Arc Essentia are available. The Essentia E1A is designed for simple EEGs in a private practice setting. The Essentia E3A is intended for long-term monitoring (LTM) and epilepsy monitoring (EMU), and for brain monitoring in Intensive Care Units (ICU).
Page 7: Essentia Indications For Use
Essentia Indications for Use Cadwell Flex Indications for Use (Arc Alterna, Arc Essentia): The Cadwell Flex system is indicated for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (EEG) ambulatory and/ or clinical studies of patients of all ages.
Page 8: Arc Essentia Setup Instructions
Arc Essentia Setup Instructions Unpacking the System Thank you for selecting the Cadwell Arc Essentia system! It’s time to unpack the contents of your sys- tem. As you unpack, please carefully check to make sure the contents of the shipping box match the packing slip.
Page 9: Arc Essentia Amplifier Options
The E3A option provides storage rates of 1000 Hz and 2000 Hz for continuous EEG monitoring in the ICU and LTM. Additional features not provided in the E1A version include USB SpO2 (contact Cadwell for device availability) and continuous impedance capabilities. The E3A has orange protective bumpers. The Essentia E3A has an LED top panel on the amplifier to allow for impedance checking, electrode con- tinuity check and to continue recording.
Page 10: Connections And Power Instructions
5. If USB Oximeter (SpO2) purchased, plug into the USB port on the computer. To turn the equipment off: Turn off equipment in the following order: 1. Close the Arc Essentia program and any other related programs running on the computer. 2. Shut down Windows. 3. Turn off monitor (for desktop configurations only).
Page 11: Computer, Network, It Security
A PC is required for use to run the Arc software. Either a laptop, tablet or desktop PC may be used. The PC may be purchased from Cadwell and provided with the Essentia system, or the customer may pur- chase their own PC as long as it meets the minimum computer requirements specified by Cadwell.
Page 12: Antivirus Software And Disk Encryption Software Applications
Cadwell encourages all customers to take necessary precautions to protect computer systems from mali- cious programs. We also want you to protect the privacy of your patient data. Though Cadwell has con- figured Arc software with multiple AV and disk encryption applications, we cannot verify compatibility with all applications available in the marketplace.
Page 13: Arc Application Instructions
To Open the Arc program 1. Double-click on the Arc icon on the Windows desktop. 2. Log in to Arc with your Cadwell login. NOTE: The default user name and password is “admin”. It is recommended that the user change the admin password.
Page 14: Essentia Setup Verification
Scheduled Appointments window. NOTE: If CadSchedule and/ or HL7 are not installed, the Scheduled Appointments section of the window will not appear, click on the study type button to begin a recording. © 2021 Cadwell Industries, Inc.
Page 15 Essentia User Guide 100870-639 Rev 07 3. You will see this screen as it loads: 4. Once the study is ready to begin, click the button at the upper left. © 2021 Cadwell Industries, Inc.
Page 16: Reviewing The Recording
8. After the study has elapsed five minutes, click on the red X in the upper right-hand corner and select Yes on the prompt that appears. Reviewing the Recording 1. To review the recording that you just made, click on the Review Records tab next to Start Record- ing toward the upper left. © 2021 Cadwell Industries, Inc.
Page 17: Additional Help Resources
For more information on how to use the Arc software application and equipment, please refer to the Arc Help Topics. Whenever the Arc application is open, select the question mark at the upper right, then select Help to access the Help Topics. © 2021 Cadwell Industries, Inc.
Page 18: Generating Reports
Skip. This will remove the selection entirely from the paragraph. If multiple selection lists are associated with the selected paragraph, then the user can select Next to advance to the next selection list in the paragraph. © 2021 Cadwell Industries, Inc.
Page 19 If some narratives have been skipped, then an unresolved narrative prompt will appear. Select Yes if done or No to go back and resolve more items. *note: As the narratives/ paragraphs are being selected the report will reflect the current selections. © 2021 Cadwell Industries, Inc.
Page 20: Report Generation Controls
When this option is selected, the below User Authentication window appears. Select the User Name from the list and enter the password, select Authenticate. That authenticated Arc user's signature will then be inserted at the current cursor position in the report. © 2021 Cadwell Industries, Inc.
Page 21: Release Note Reference
Release Note Reference Release notes will be automatically installed during the installation of the Arc software, and may be optionally viewed at the end of the installation. Alternatively, see the Arc Help file (click the in Arc). © 2021 Cadwell Industries, Inc.
Page 22: General Warnings And Cautions
1. Federal law restricts sale of this system to, or on the order of, a physician. 2. No user serviceable parts inside. Service by Cadwell Industries, Inc. and other authorized bodies only. Do not modify this equipment without authorization of the manufacturer.
Page 23 Cadwell EEG system. 39. The Cadwell Oximeter is not intended to be used as a critical care decision device. It acquires sec- ondary oximetry data for long-term analytical decisions and is intended to be used in combination with EEG acquired information.
Page 24 54. Components of the system are not intended to be patient contact devices. 55. Warning. The Arc Essentia does not incorporate means to protect the patient against burns when used with High Frequency (HF) surgical equipment. Connection of patient to high frequency elec- trosurgical equipment and electroneurodiagnostic equipment simultaneously may result in burns at the site of the amplifier electrodes, and possible damage to the amplifier.
Page 25: Symbols And Meanings
Manufacturer MDD, MDR, 15223 European Authorized Representative EN 980 Waste Electrical and Electronic Equipment Recycle or dispose of equipment WEEE according to country regulatory requirements Indicates device is a medical device Indicates UDI label 15223 © 2021 Cadwell Industries, Inc.
Page 26 1 The first digit “2” designates ingress protection of objects 12.5 mm or larger; for example, fingers or similar objects. The second digit “2” indicates protection against dripping water when the enclosure is tilted at an angle up to 15° from the normal position. © 2021 Cadwell Industries, Inc.
Page 27: Date Of Manufacture
XXXXXX | XX | X | X | XX | XX | XXX For example, the following serial number equates to date of manufacture 2017-08 (YYYY-MM) XXXXXX | XX | X | X | 08 | 17 | XXX © 2021 Cadwell Industries, Inc.
Page 28: Essentia Essential Performance
201.12.1.101.5 Common mode rejection Essential performance can be verified by the following: • Cadwell Industries, Inc. will verify essential performance during any preventative maintenance or ser- vice routines. • The user can verify essential performance requirements using the test procedures and pass/ fail cri- teria outlined in Section 201.12.1.101 of IEC 60601-2-26:2012.
Page 29: Maintenance Information
Essentia Specifications and Operating Environment and Limits Refer to Essentia Specification document 100870-931 for detailed specifications. The Arc Essentia meets the following internationally recognized safety standards for Medical Electrical Equipment: IEC 60601-1: 2012 General Requirements for Basic Safety and Essential Performance CSA C22.2#60601-1: 2008 (CB Scheme) General Requirement for Basic Safety and Essential Per-...
Page 30: Mode Of Operation
Essentia User Guide 100870-639 Rev 07 Mode of Operation Continuous © 2021 Cadwell Industries, Inc.
Page 31: Safety
1. All Cadwell equipment and accessories are permissible in the PATIENT ENVIRONMENT without incorporating a SEPARATING TRANSFORMER. 2. A double insulated Laptop Computer powered from Cadwell equipment is permissible in the PATIENT ENVIRONMENT without incorporating a SEPARATING TRANSFORMER. 3. Other computing devices (i.e. desktop computer, monitor, printer, camera, IR illuminator etc.) are NOT allowed in the PATIENT ENVIRONMENT unless a SEPARATING TRANSFORMER is used to power those devices.
Page 32 6. SEPARATING DEVICE: a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of the MEDICAL ELECTRICAL SYSTEM. 7. FIXED MAINS OUTLET: permanently installed (hard wired) grounded outlet in a facility. © 2021 Cadwell Industries, Inc.
Page 33 9. SINGLE FAULT: Condition in which a single means for protection against a safety hazard in the SYSTEM is defective or a single external abnormal condition is present. Contact Cadwell Industries, Inc. Quality/ Regulatory Department with any questions regarding these requirements. © 2021 Cadwell Industries, Inc.
Page 34: Essentia Electromagnetic Emission And Immunity To Electromagnetic Disturbances
WARNING: Portable RF communications equipment (including peri- pherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Arc Essentia, including cables specified by the manufacturer. Otherwise, degrad- ation of the performance of this equipment could result.
Page 35 Magnetic disturbances higher than 30 A/m may cause Immunity IEC events in the displayed waveforms. This is an unavoid- 610000-4-8 able phenomenon due to the high input sensitivity of the equipment. These waveform disturbances can be © 2021 Cadwell Industries, Inc.
Page 36 Voltage Inter- 0 % UT; 250/300 cycle For long interruptions the system maintains its func- ruptions IEC tionality if the Arc Essentia is powered from a laptop 61000-4-11 and the laptop battery is charged. Table 1 Recommended separation distances between portable and mobile RF communications equipment...
Page 37 Essentia system is used exceeds the applicable RF compliance level of IEC 60601-1-2:2014, the Essentia system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system. © 2021 Cadwell Industries, Inc.
Page 38: Essentia Cleaning Instructions
Essentia system. As you clean, visually inspect the instrument and its components for damage or wear. Contact Cadwell if you notice damage to the exterior of the instrument. Do not attempt to service or repair damaged or inoperable equipment. If you suspect a problem, contact the Cadwell Service Department at 800-245-3001.
Page 39: Disposal Of Equipment
For equipment warranty details and extended service package information, please see Cadwell's Terms www.cadwell.com/terms of Service at Electrode Catalog and eStore Cadwell has an online electrodes catalog and eStore. Cadwell representatives are available to take your order at 800-245-3001. www.estore.cadwell.com Cadwell eStore:...
Page 40: Customer Support And Contact Information
Remote Assistance Remote assistance and troubleshooting is available for systems under warranty or service contract. With your permission, a support technician can establish a secure connection to your Cadwell instrument via the internet. Please call the service department or application support department. A support or service technician will verify your account information and guide you through the steps to begin a remote assistance ses- sion.