Who is the manufacturer of Cadwell Sierra Summit, Cadwell Sierra Ascent?

Cadwell Industries, Inc. filed the 510(k) submission for Cadwell Sierra Summit, Cadwell Sierra Ascent (K162383).

What is the FDA product code for Cadwell Sierra Summit, Cadwell Sierra Ascent?

IKN. It is classified under 21 CFR 890.1375 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for Cadwell Sierra Summit, Cadwell Sierra Ascent?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cadwell Sierra Summit, Cadwell Sierra Ascent?

Carefusion Nicolet EDX with Viking Software (K112052).

Who can help prepare an FDA 510(k) submission like Cadwell Sierra Summit, Cadwell Sierra Ascent?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cadwell Sierra Summit, Cadwell Sierra Ascent

K162383 · Cadwell Industries, Inc. · IKN · Mar 1, 2017 · Physical Medicine

Device Facts

Record ID	K162383
Device Name	Cadwell Sierra Summit, Cadwell Sierra Ascent
Applicant	Cadwell Industries, Inc.
Product Code	IKN · Physical Medicine
Decision Date	Mar 1, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1375
Device Class	Class 2

Intended Use

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Story

System acquires, displays, stores, and analyzes electrophysiological signals (EMG, NCS, EP, Autonomic) from nervous/muscular systems. Inputs include electrical signals from patient via electrodes/amplifiers; system performs A/D conversion and signal processing. Output is visual display of waveforms/data for clinician review. Used in clinical settings by qualified medical practitioners. Sierra Summit includes integrated interface for third-party non-invasive imaging (e.g., ultrasound) to visualize neural/muscle morphology. Device aids in confirming electrodiagnostic results; does not provide automated diagnostic conclusions. Benefits include support for neuromuscular disease diagnosis through standardized data acquisition and reporting.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified against IEC 60601-1, IEC 60601-2-40, and internal specifications for signal acquisition, electrical safety, and electromagnetic compatibility.

Technological Characteristics

Computer-based electrodiagnostic system; Windows OS; 1-12 channel isolated amplifiers; constant current electrical stimulators (up to 100mA/400V); auditory/visual stimulators. Connectivity via USB. Biocompatible materials (ISO 10993-1) for patient-contact accessories. Safety standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-40.

Indications for Use

Indicated for qualified medical practitioners to acquire, display, and analyze electrophysiological data (EMG, NCS, EP, Autonomic) to support diagnosis of neuromuscular diseases/conditions. No patient age/gender restrictions. Contraindicated for use with flammable anesthetics or defibrillation equipment.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Predicate Devices

Carefusion Nicolet EDX with Viking Software (K112052)

Reference Devices

Cadwell Kilowin (Easy II EEG, Sierra II EMG/EP, Cascade IOM) (K971214)
Telemed Ultrasound System (K113184)
Interson USB Ultrasound Probe System (K070907)

Related Devices

K120979 — CAREFUSION NICOLET EDX · Carefusion 209, Inc. · Apr 25, 2012
K130346 — SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION · Natus Neurology Incorporated · May 2, 2013
K965065 — TECA. MILLENNIUM · Medelec , Ltd. · Jun 20, 1997
K070109 — NEUROMETRIX ADVANCE · Neurometrix, Inc. · Apr 25, 2008
K991899 — NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES · Nihon Kohden America, Inc. · Sep 1, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 1, 2017 Cadwell Industries, Inc. Christopher Bolkan QA/RA Engineer 909 North Kellogg Street Kennewick, Washington 99336 Re: K162383 Trade/Device Name: Cadwell Sierra Summit, Cadwell Sierra Ascent Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, GWF, JXE, GWJ, GWE, GZP Dated: January 19, 2017 Received: January 23, 2017 Dear Christopher Bolkan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. ### Michael J. Hoffmann -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K162383 Device Name Cadwell Sierra Summit, Cadwell Sierra Ascent #### Indications for Use (Describe) Cadwell Sierra Summit: Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. Cadwell Sierra Ascent: Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Cadwell logo in black and white. The logo consists of the word "CADWELL" in a bold, sans-serif font, with a stylized circle containing a waveform to the left of the word. Below the logo is the tagline "Established. Focused. Global." also in black. ### 510(k) Summary Cadwell Sierra Summit and Ascent [A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92] ### 1. Submitter / 510(k) Holder: | Name | Cadwell Industries, Inc. | |-----------------------|----------------------------------------------------| | Address | 909 N. Kellogg Street, Kennewick, Washington 99336 | | Establishment Reg No. | 3020018 | | Contact person | Mr. Chris Bolkan | | Phone number | 509-735-6481 | | Fax number | 509-783-6503 | | Email | ChrisB@Cadwell.com | | Date Prepared | August 5, 2016 | ### 2. Device Name: | Proprietary name | Cadwell Sierra Summit, Cadwell Sierra Ascent | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common name | Diagnostic Electromyograph | | Device Class | Class II | | Classification name | Electromyograph, Diagnostic Stimulator, Electrical, Evoked Response Device, Nerve Conduction Velocity Measurement Stimulator, Auditory, Evoked Response Stimulator, Photic, Evoked Response Stimulator, Mechanical, Evoked Response | | Product Code, Regulation | IKN 21 CFR 890.1375 GWF 21 CFR 882.1870 JXE 21 CFR 882.1550 GWJ 21 CFR 882.1900 GWE 21 CFR 882.1890 GZP 21 CFR 882.1880 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a black circle with a white heartbeat symbol inside. The letters of the word are connected to each other, creating a single, unified shape. The overall design is modern and professional. | 3. Predicate Devices: | 510(k) Number | Device Name | |-----------------------|---------------|-----------------------------------------------------------------| | Primary Predicate | K112052 | Carefusion Nicolet EDX with Viking Software | | Reference Predicates | K971214 | Cadwell Kilowin (Easy II EEG, Sierra II EMG/EP, Cascade IOM) | ### 4. Device Description: The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems. The Sierra Summit provides a variety of test protocols spanning the various test modalities above. The Cadwell Sierra Summit consists of the following major components: - Sierra Summit console base unit with integrated control panel ● - Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license) - Laptop or Desktop computer (Windows OS) with keyboard and mouse ● - Display monitor ● - Summit software The Sierra Summit has the following optional accessories/components: - Remote Head Box (for 3-12 channel amplifier) ● - StimTroller (Hand Held Electrical Stimulator) - Electrical Stimulator Switch Box ● - Footswitch (single) ● - Visual Stimulators (LED Goggles, LCD Checks) - VEP Calibration Sensor - Headphones or other auditory transducers - Reflex Hammer - Temperature Probe ● - Cart - Isolation Transformer or Medical Grade Power Strip - Printer {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word, there is a black circle with a white line running through it, resembling a heartbeat symbol. The letters are closely spaced, creating a solid, impactful visual. ### 5. Indications for Use ### Sierra Summit: Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and muscles, and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. ### Sierra Ascent: Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. ### 6. Summary of Technical Characteristics Compared to the Predicate Devices The Cadwell Sierra Summit and Ascent are substantially equivalent to predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas that include intended use, design, functionality, principle of operation, specifications, material composition, and performance. | 1. General | | | | | | |----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | This Submission | This Submission | Reference Predicate | Primary Predicate | | | Characteristics | | Cadwell Sierra Summit | Cadwell Sierra Ascent (variant of Summit) | Cadwell Kilowin (Sierra II EMG/EP) (K971214) | Carefusion Nicolet EDX with Viking Software (K112052) | | 1.1 Indications for Use | | | | | | | | | Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used as an aid in the location of neural structures or muscle, to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non- invasive imaging display and control is | Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used as an aid in the location of neural structures or muscle, to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the | Kilowin is an electrodiagnostic device designed to measure and display the electrical signals generated by peripheral nerve, muscle, and central nervous system. It will acquire the data necessary for electroencephalograp hy (EEG), electronystagmograph y (ENG), electrocardiology (ECG), electromyography (EMG), nerve conduction velocity (NCV, F Wave, and H reflex), evoked potentials (EP, brainstem, visual, somatosensory), repetitive nerve stimulation and sleep assessment. The Kilowin instrument is designed for use during the duration of the procedure only. Use of the proposed device is to be administered under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in the operating room or clinic. The Kilowin device(s) are intended for use during | The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiologic information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative monitoring including Electroencephalography (EEG). Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP). The Nicolet EDX with Viking Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The listed modalities do include overlan in | | | | | | | | | | used to visualize the morphology and location of nerves and muscles, and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. | patient's condition to the user. | electroencephalograp y (EEG), electronystagmograph y (ENG), electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), evoked potentials (brainstem, visual, somatosensory) repetitive nerve stimulation testing and sleep assessment. | functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve, Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Nicolet EDX with Viking Software is intended to be used by a qualified healthcare provider. | | | 1.2 Warnings | Items related to off- label use or misuse. | Items related to off- label use or misuse. | Items related to off- label use or misuse. | Items related to off-label use or misuse. | | | 1.3 Contra- indications | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment. | | | 2. General Design | | | | | | | 2.1 General Systems Approach | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | | | 2.2 User Input Device | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Windows mouse/keyboard driven graphic interface with dedicated control panel. | | | 2.3 User Output Device | Digital color display and commercial printers. | Digital color display and commercial printers. | Digital color display and commercial printers. | Digital color display and commercial printers.…