Dräger Scio Four - User Manual

Need help?

Do you have a question about the Dräger Scio Four and is the answer not in the manual?

Overview

Function Description
Important Technical Specifications
Usage Features
Maintenance Features
Safety Information

This document serves as a supplement to the instructions for use of various Dräger patient monitors, including the Infinity Acute Care System, Infinity Delta Series, Infinity Gamma XL, Infinity Gamma XXL, Infinity Kappa XLT (only for Scio Four plus and Scio Four Oxi plus), Infinity Vista XL, and Vista 120/Vista 120 S. It provides specific information about the Scio Four modules (part numbers 6871801, 6871802, 6871803, and 6871804), which are collectively referred to as "gas analyzer" or "medical device" throughout the text.

Function Description

The Scio Four module is designed for continuous sidestream gas measurement in adult and pediatric patients. It samples gases from non-rebreathing, partial rebreathing, and total rebreathing systems, measuring both inspiratory and expiratory gases. The measured and derived values are communicated in real-time to the patient monitor.

The gas analyzer utilizes infrared (IR) spectroscopy for measuring carbon dioxide (CO2), nitrous oxide (N2O), and volatile anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane). Each gas has a specific absorption characteristic and is transported through a sample cell. Multiple optical IR filters select specific bands of IR light, which are then analyzed by a detector. The amount of IR light received by the detector is inversely proportional to the gas concentration; higher concentration means less IR light received. For oxygen (O2) measurement, the paramagnetic characteristic of oxygen molecules is used. The gas passes through a sample cell where the paramagnetic effect of oxygen is measured, with a stronger effect indicating higher O2 concentration.

The Scio Four module is available in four variants with different functional scopes:

Scio Four: Measures CO2, N2O, and 1 out of 5 anesthetic agents. No O2 or mixtures.
Scio Four Oxi: Measures O2, CO2, N2O, and 1 out of 5 anesthetic agents. No mixtures.
Scio Four plus: Measures CO2, N2O, and 2 out of 5 anesthetic agents. Yes mixtures. No O2.
Scio Four Oxi plus: Measures O2, CO2, N2O, and 2 out of 5 anesthetic agents. Yes mixtures.

Important Technical Specifications

Dimensions (with water trap): Height 115 mm (4.8 in), Width 190 mm (7.5 in), Depth 270 mm (10.5 in).
Weight:
- Scio Four: 2.9 kg (6.4 lbs)
- Scio Four Oxi: 3.2 kg (7.0 lbs)
- Scio Four plus: 2.9 kg (6.4 lbs)
- Scio Four Oxi plus: 3.2 kg (7.0 lbs)
Mode of operation: Continuous.
Device noise emissions: ≤45 dB(A).
Cooling: Fan, temperature-regulated.
Mains power supply: 100 to 240 V~ 50/60 Hz.
Inrush current: 15-55 A.
Power consumption: ≤50 W.
Housing leakage current: ≤300 µA (per UL 60601-1:2003), ≤500 µA (per UL 60601-1:1988 incl. corrections).
Protection classes: Device Class 1, Electric shock protection Type BF, Penetration of liquids IP21.
Classification according to MDD 93/42/EEC - Annex IX: IIa.
UMDNS Code: 17-445.
Latex use: No latex (natural rubber) is used in parts with indirect or direct contact to patients or operators.
Ambient Conditions:
- During operation: Temperature 10 to 40 °C (50 to 104 °F), Atmospheric pressure 700 to 1060 hPa (10.2 to 15.4 psi) with automatic barometric pressure compensation, Relative humidity 20 to 95 % (without condensation), CO2 concentration <1000 ppm.
- During storage and transport: Temperature –20 to +70 °C (–4 to 158 °F) for the device, –40 to +70 °C (–40 to 158 °F) for power supply (MS18508), Atmospheric pressure 500 to 1060 hPa (7.3 to 15.4 psi), Relative humidity 5 to 95 % (without condensation), 20 to 95 % for power supply (MS18508).
Device Outlets:
- Serial interfaces (RS232 and MEDIBUS): 9-pole Sub-D, galvanically isolated 1.5 kV against internal electronics, 0.5 kV against housing. Baud rates from 1200 to 38400 baud.
Gas Measurement:
- Method: Sidestream gas measurement. All values measured under ATPS conditions, sampling rate calibrated under NTPD conditions. End-tidal gas concentration is the value measured at maximum CO2 concentration in the expiratory phase.
- Sampling rate: 200 mL/min ±20 mL/min.
- Maximum time to empty water trap: 41 hrs (sample gas under BTPS conditions, ambient air 23 °C).
- Gas leakage: <10 mL/min.
- Data sample rate: <50 ms.
- Delay time: <2.4 s.
- Total system response time: <3 s (sum of delay time and gas-specific rise time T10...90).
- Cross sensitivity: <0.2 Vol% for volatile agents, CO2, and N2O; <1 Vol% for O2; against ethanol (<3000 ppm), isopropanol (<10000 ppm), acetone (<1000 ppm), methane (<1000 ppm), saturated humidity at 37 °C.
- Drift: Compensated by automated cyclical zeroing.
- O2 Range: 0 to 100 Vol%, Accuracy ±(2.5 Vol% + 2.5 % rel.), Rise time (T10...90) <500 ms.
- CO2 Range: 0 to 10 Vol%, Accuracy ±(0.43 Vol% + 8 % rel.), Rise time (T10...90) <300 ms.
- N2O Range: 0 to 100 Vol%, Accuracy ±(2 Vol% + 8 % rel.), Rise time (T10...90) <300 ms.
- Anesthetic Agents Range: Halothane 0 to 8.5 Vol%, Isoflurane 0 to 8.5 Vol%, Enflurane 0 to 10 Vol%, Sevoflurane 0 to 10 Vol%, Desflurane 0 to 20 Vol%. Accuracy ±(0.20 Vol% + 15 % rel.), Rise time (T10...90) <450 ms.
- Automatic detection: Primary gas at latest 0.3 Vol%, Secondary gas at latest 0.4 Vol%. For Desflurane concentrations >4 Vol%, mixture detection occurs at latest when the second anesthetic agent rises above 10% of Desflurane concentration.
- Respiratory Rate (RR): Range 0 to 100 /min, Accuracy 0 to 60 /min: ±1 /min with I:E ratio 1:1; 0 to 80 /min: ±1 /min with I:E ratio 1:2. Resolution 1 /min.

Usage Features

Assembly and Preparation: The power supply unit can be mounted with the mains power inlet downwards or horizontally with the label downwards. It must not be mounted with the inlet pointing upwards. Connect the power supply to the gas analyzer, then the power cable to the power supply and wall socket. Establish potential equalization by connecting the cable to the device's pin and then to the hospital's potential equalization connector. Connect the gas analyzer to a patient monitor (e.g., Infinity Acute Care System, Infinity Delta Series, etc.) using the data interface cable.
Water Trap: The water trap must be emptied or exchanged according to its instructions for use. It is crucial to handle contaminated liquid with care and dispose of it properly. Disconnect the sample line before removing the water trap to prevent spillage of contaminated liquid. Do not operate the device without the water trap installed.
Sample Line Connection: Connect the sample line to a Y-piece, HME filter, or hose adapter with Luer Lock, then to the water trap. Ensure the sample line is undamaged and properly connected to avoid faulty gas measurements. Used sample lines are infectious and must be replaced after each patient unless a bacterial filter is in place.
Gas Scavenging: Use a sample gas return kit to connect the gas analyzer's exhaust port to the anesthesia workstation's return port. If recirculation is not possible, connect the exhaust port to the anesthetic gas scavenging system.
Starting Operation: Connect the mains plug and set the On/Off switch to "ON". The gas analyzer undergoes an initialization and warm-up period, during which gas concentrations and anesthetic agent identification may not be available.
Monitoring: Configure and use the patient monitor according to its instructions for use.
Tasks Before Patient Change: Clean and disinfect the gas analyzer, check and empty/replace the water trap, and replace the sample line if no bacterial filter is used.
Switching Off: Set the On/Off switch on the rear of the device to "OFF".

Maintenance Features

Cleaning and Disinfection: The device surfaces and cables are classified as non-critical medical devices. Cleaning and disinfection procedures have been tested with specific agents (e.g., Dismozon plus) and must be strictly followed. Dräger recommends using surface disinfectants from a validated list. Do not wash or disinfect the inside of the sample line or water trap, and do not sterilize them.
Fan Filter Mat: The fan filter mat should be cleaned monthly or replaced annually. Locate the fan at the rear, remove the mat from its holder, vacuum accumulated dust, and then reinsert the cleaned or new mat.
Inspection: Inspections must be performed regularly (every 12 months) by service personnel according to guidelines. This includes checking documentation, device condition (labels, visible damage to housing, power supply, cables, water trap, O-rings, sample line, gas exhaust, power LED), and electrical safety (IEC 62353).
Preventive Maintenance: This includes replacing the fan filter mat annually, and the bacterial filter of the sample gas return kit and O-rings on the water trap mount every 2 years, all performed by service personnel.
Calibration: The gas analyzer is self-zeroing and does not require calibration. However, calibration components must be checked annually by service personnel.
Disposal: The device and its components must be disinfected and cleaned before disposal. Consult relevant waste disposal companies and comply with local regulations. For EU countries, follow WEEE Directive 2002/96/EC guidelines, contacting Dräger for authorized collection and disposal. Accessories like filters, water traps, and sample lines should be disposed of according to hospital hygiene regulations.

Safety Information

General Safety: Strict adherence to all warnings and cautions in this supplement and the patient monitor's instructions for use is mandatory.
Electromagnetic Compatibility (EMC): The device is subject to special EMC precautions. It must be installed and operated according to the EMC information in the patient monitor's instructions for use. Maintain a minimum distance of 0.3 m (1.0 ft) from wireless communication devices and adequate distance from other medical electrical equipment to ensure essential performance.
Explosion/Fire Risk: Do not use the device in areas with oxygen concentrations exceeding 25% or where combustible/explosive gas mixtures may occur. Keep the device at least 25 cm (10 in) from ignition sources.
Patient Injury: Data transmitted via MEDIBUS is for information only and not for diagnostic/therapeutic decisions. Electrical connections to unlisted equipment must be approved by the respective manufacturer.
Gas Measurement Accuracy: Use authentic Dräger sample lines to avoid erroneous readings. Never use standard pressure-sensor tubing or IV lines (PVC) as they absorb anesthetic agents.
Oxygen Supply: The sample flow may reduce breathing system volume in low-flow anesthesia; compensate by increasing fresh-gas flow or returning sample gas to the breathing system.
Device Malfunction: Magnetic fields (MRI, NMR, NMI) can negatively influence device function. Do not obstruct the cooling fan. Modifications to the device may lead to malfunctions.
Infection Risk: Liquids in the water trap and used sample lines can be contaminated. Handle and dispose of them with care.
Electrical Shock: Connecting devices to RS232 or MEDIBUS interfaces can increase leakage current. Ensure proper grounding and have leakage current checked by service personnel.