OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER

• K Number: K955059
• Device Name: OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 1996-06-07 ( 214 days)
• Product Code: DSI
• Regulation Number: 870.1025
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K946306 , K944350 , K920445 , K900598 , K901072 , K912799 , K901884

Intended Use

Olympus Communications Network: To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers.
SC 3000 Workstation: To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network.
SC 3000 Remote Display: To act as a Slave Display for the SC 3000 Workstation.

Device Description

Not Found

AI/ML Overview

This document describes the safety and effectiveness information for the Siemens Olympus Communications Network, SC 3000 Workstation, and SC 3000 Remote Display. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on:

• General Information: Device classification, common names, trade names, intended uses, and establishment details.
• Safety and Effectiveness Information II: Compliance with electrical standards (IEC 601-1, UL 544, UL 433, EN 60950, UL 1950, CSA 22.2 No. 950, CE Mark), operational instructions, and adherence to a product development process for design and testing.
• Substantial Equivalence III: Comparison to previously cleared predicate devices from Siemens (SIRENET Communications Network, SIRECUST 120/121C Central Station, SIRECUST 120/121S Slave Display) and Marquette (Unity Network, CentralScope™ 12 Central Station, Remote Color Display).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the given text.

To answer your request, the input document would need to include sections detailing:

• Specific performance metrics (e.g., accuracy, reliability, latency for communication networks; display resolution, refresh rates for workstations/displays).
• Quantitative acceptance thresholds for these metrics.
• Protocols and results of a study (e.g., validation testing, clinical trials) designed to demonstrate that the device meets these thresholds.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.