(190 days)
Intended use:
The Datex-Ohmeda S/5 Single-width airway module, M-miniC is intended to be used with Datex-Ohmeda S/5 modular monitors; S/5 Anesthesia Monitor, S/5 Compact Anesthesia Monitor, S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor for monitoring CO2 and respiration.
Indications for use:
The Datex-Ohmeda S/5 Single-width airway module, M-miniC and accessories is indicated for monitoring CO2 and respiration rate of all hospital patients. M-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.). The device is indicated for use by qualified medical personnel only.
The M-miniC is used in the Datex-Ohmeda S/5 modular family which consists of four different types of monitors: Anesthesia Monitor, Compact Anesthesia Monitor, Critical Care Monitor and Compact Critical Care Monitor. An monitor consists of four basic elements: display, keyboard, Central unit and modules. The display shows up to eight waveforms, real-time data and trends. With keyboard you can control the monitor. The keyboard consists of membrane keys and a comwheel. By pushing a key you can open a menu in which you can move by turning the comwheel.
The M-miniC module consists of miniCO2 infrared measuring sensor for measuring CO2. It is assembled in a Single-width module, which occupies one slot in a Datex-Ohmeda S/5 modular monitor frame. The main accessories include airway gas sampling lines, mini D-fend water traps and airway adapters The module is first plugged into the frame of the monitor. The sampling line is attached to the module connector. The monitor is switched on and the gas sampling line is attached to the airway adapter. The airway adapter is attached between ventilator Y-piece and Heat and moisture exchanger (HME) of the patient's intubation tube. The monitor displays measurements from the M-miniC module in the form of numeric values, curve and trends. The monitor also generates audible and visual alarms for this module and indicates the priorities and sources of alarms.
The Datex-Ohmeda S/5™ Single-width Airway Module M-miniC is a carbon dioxide gas monitor. The provided text outlines its intended use, technological characteristics, and a summary of nonclinical testing, but does not contain specific acceptance criteria or an explicit study proving device performance against such criteria.
However, based on the nonclinical testing summary, we can infer that the device was tested to comply with relevant safety and performance standards. The text states: "The Datex-Ohmeda S/5TM Single-width Airway Module M-miniC and accessories complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications."
The standards listed represent the implicit acceptance criteria that the device had to meet. The "reported device performance" then is its successful compliance with these standards.
Here's an attempt to structure the information conceptually, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Standards Compliance) | Reported Device Performance (Summary from Text) |
|---|---|
| Electrical Safety (e.g., IEC 60601-1, CAN/CSA-C22.2 No. 601.1-M90, UL 2601) | Complies with IEC 60601-1:1988+Amdt 1:1991+Amdt 2:1995, EN 60601-1: 1990+A1:1993+A2:1995+A13:1996, CAN/CSA-C22.2 No. 601.1-M90 +S1:1994+Amdt2:1998, UL 2601:1997 |
| Electromagnetic Compatibility (EMC) (e.g., IEC 60601-1-2) | Complies with IEC 60601-1-2:1993, EN 60601-1-2:1993 |
| Software Validation & Verification of Specifications (e.g., IEC 60601-1-4) | Complies with IEC 60601-1-4:1996+Amdt 1:1999, EN 60601-1-4:1996+Amdt A1:1999 |
| Carbon Dioxide Gas Monitor Performance (e.g., ISO 9918, ASTM F-1456) | Complies with ISO 9918:1993 / EN 864:1996, ASTM F-1456 (1992). The text also explicitly states the CO2 measurement range is 0 to 20 vol%, warm-up time is 1 min, sample flow is 150 ml/min, and CO2 rise time is |
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).