Reference Manual
162 Pages
Preview
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Scio Module Reference Manual
for use with
SC 7000/8000/9000XL
SCIO MODULE REF 6871255 Reference Manual for use with SC 7000/8000/9000XL Software VF2.x The Scio Module is manufactured by Dräger Medical AG&Co. KGaA 23542 Lübeck, Germany This device bears the mark in accordance with the provisions of the Directive 93/42/EEC of June 14, 1993 concerning medical devices.
Distributed by: Siemens Medical Solutions USA, Inc. Electromedical Group 16 Electronics Avenue Danvers, MA 01923 Siemens AG 2003. All rights reserved
Printed in Germany These instructions are intended to supplement the information in the Siemens SC 7000/8000/9000XL operating instructions. See the SC 7000/8000/ 9000XL User’s Guide for complete information. Reproduction in any manner, in whole or in part, in English or in any other languages, except for brief excerpts in reviews and scientific papers is prohibited without prior written permission of Siemens AG. Before using all Siemens devices, read all the manuals that are provided with your device carefully. Medical equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.
SCIO MODULE Table of Contents Overview ... 2 Hardware Setup ... 4 Site of Operation ... 4 Installing the Water Trap ... 5 Connections ... 5 Warm-Up ... 6 Calibration ... 6 Scio Setup ... 8 etCO2* Monitoring ... 8 O2/N2O Monitoring ... 10 Agent Monitoring ... 12 Combined Display (O2/Agent/N2O) ... 15 Maintenance and Repair ... 16 Status Messages ... 20 Accessories ... 21 Technical Data ... 22 Scio Module ... 22 MultiGas ... 23
Overview The Scio module is a free-standing unit that samples breathing gases from adults and pediatric patients in non-, partial- and total rebreathing systems. It continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture. It communicates real time and derived gas information to the host system. Except for N2O, the monitor saves values derived by the modules in its trend storage. CAUTION: The gas information is intended to be used by trained and authorized health care professionals only.
The Scio module calculates both inspiratory and expiratory O2 values (iO2 and etO2). Full technical descriptions of the Scio module is available from your local Siemens representative. The sample flow rate of the Scio module is fixed at 150 ml/min. (±20 ml/min.) WA RN IN G : If the 170 ml/min. flow rate is not suitable for patients with compromised respiratory status, the physician should increase the fresh gas supply to satisfy the patient’s respiratory requirements.
The Scio module uses infrared light for the measurement of CO2 and volatile anaesthetics. A small amount of the patient respiratory gas is drawn through a measuring chamber. An infrared light is shone through the chamber and the gas sample absorbs different amounts of light. A paramagnetic cell is used for the measurement of O2. This cell uses a physical reaction that is proportional to the O2 concentration. Mechanical shocks during measurement or the presence of other paramagnetic agents can distort the measurement of oxygen concentration. Siemens disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences which might result from the combination of this product with other products, whether supplied by Siemens or by other manufacturers, if such a combination is not endorsed by Siemens. CAUTION: The Scio module purges and zeroes itself approximately once every two hours. The purging/zeroing cycle lasts no longer than 25 seconds. Waveforms flatline and P-box values blank from the screen during this cycle. Multigas Zero in Progress appears in the message box.
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Scio Module NOTES: !
The Scio module requires 510(k) review and is not yet commercially available in the US.
!
The Scio module is not yet licensed in accordance with the Canadian Medical Device Regulations.
!
The presence of organic cleaning solutions or gases containing freon may impact the accuracy of the Scio module.
Scio Module
Front View
Water trap External Power indicator
Labels:
Rear View
Hardware version
Fan exhaust screen X2 connector
Software version
Exhaust port Safety label
Safety label
External Power Supply connector
Safety Labels:
!
Attention! Consult the accompanying document.
Gas out
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Hardware Setup Site of Operation The site of operation must meet the temperature, humidity, and atmospheric pressure requirements listed on page 22. In addition, observe the following guidelines: !
Make sure that the platform which supports the module is large enough, level, and stable.
!
Make sure that the fan exhaust screen at the rear of the module and the ventilation holes on the underside are not obstructed.
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Place the module at least 25 cm (10 inches) from any possible source of ignition, such as sparking.
!
Place the module close enough to the patient so that the sampling tubing can reach the airway T-connector and the exhaust tubing the hospital’s exhaust gas scavenging system without stretching. WA RN IN G S :
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!
Do not use mobile phones within 33 feet (10 m) of the Scio module. Wireless phones may cause failure.
!
Do not expose the Scio Module to mechanical vibrations or shock during measurement. Mechanical vibrations or shock can have adverse effects on gas measurement values.
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The operation of the Scio module in magnetic resonance imaging environments (MRI) is not supported.
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Do not use a Scio module near devices with microwave or other high-frequency emissions. These emissions may interfere with the modules’ operation.
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SC 7000/8000/9000XL and the Scio Module must both be powered from hospital grade connectors within the same medically used room.
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When the SC 7000/8000/9000XL is used with the Scio it meets the Class A limits of CISPR11. The system is not intended for connection to public mains.
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Scio Module Installing the Water Trap Install the water trap into its receptacle on the Scio module by pushing against the Scio. A click will indicate that it is seated properly. Confirm that the water trap is empty. (For information on replacing the water trap, see page 18.)
Connections The Scio module connects to the SC 7000/8000/9000XL monitor via an INFINITY DOCKING STATION (IDS) or an INFINITY device Communication Power Supply (CPS). Scio functions are not available in DirectNet mode. WA RN IN G S : !
Do not use the module without a Watertrap.
!
Sampling tubing should be kept as short as possible (but not stretched) to minimize dead space and optimize response time. Long sampling lines degrade the performance of side stream measurements, may affect accuracy, and result in slower response times.
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Always use Siemens-approved Scio sampling tubing (polypropylene). Never use standard pressuresensor tubing (PVC). PVC tubing absorbs anesthetic agents, which it later releases (degassing). The use of standard PVC tubing can result in erroneous agent concentration readings.
!
To avoid the risk of explosion, do not use flammable anesthetic agents such as ether and cyclopropane with the Scio module.
Connect the module and tubing as follows: 1. Connect one end of the sampling tubing to the water trap, and the other end to the airway T-connector. (For information on changing sampling tubing and T-connector, see page 17). 2. Connect one end of the exhaust tubing to the exhaust port at the rear of the module, and the other end to the hospital’s gasscavenging system.
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X2 connector
Exhaust port External Power Supply connector
3. Connect one end of the monitor/module intermediate cable to the X2 connector at the rear of the module and the other end to the CPS/IDS connector marked X12 . If you are using a breakout box, connect the end to the connector on the breakout box. 4. Connect the power supply to the external power supply connector at the rear of the module. 5. Connect the power supply cord to a hospital-grade outlet.
Warm-Up Upon start-up, the Scio module passes through an initialization and warm-up period. During this time, the etCO2*, O2, and/or Agent parameter boxes display a question mark (?) and the monitor does not transmit Scio data over the network, nor is this data trended. WA RN IN G : During warm-up, reported values might not be accurate. To achieve full accuracy, a typical warm-up period of 5 minutes is recommended. Refer to the Technical Data appendix for a detailed description of Scio accuracy.
Calibration The Scio module is self-zeroing and does not need calibration by the clinical staff.
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Scio Module The O2 cell in the Scio does not require routine calibration, however, the user may choose to perform a 1-point or 2-point calibration in the event that the measured values are not as expected. A 1-point calibration is performed against room air (typically 21% ± 1% O2) and a 2-point calibration is performed against 100% O2 as well as room air. A yearly check of the Scio calibration components should be performed by authorized technical personnel.
1 Point Calibration 1. Access the O2 menu (see page 11) or the combined MULTIGAS menu (see page 15). 2. Click on 1 Point Cal. During calibration, the monitor displays the message MULTIGAS Oxygen Cal. in Progress. When the calibration is complete, the monitor displays MULTIGAS Oxygen Cal. Accepted and the current date and time appear next to the menu field Last O2 Cal. If the calibration fails, the monitor displays an error message (see page 20 for status messages).
2 Point Cal. 1. Make sure a medical-grade O2 source is available. 2. Access the O2 menu (see page 11) or the combined MULTIGAS menu (see page 15). 3. Click on 2 Point Cal. A popup screen appears with the message Supply 100% O2, then Press Continue. 4. Connect the O2 source to the water trap on the module and supply 100% oxygen. Wait until the waveform levels off at a maximum display height and the numerical data in the O2 parameter box is stable. This may take several minutes on older O2 cells. WA RN IN G : The O2 value in the MULTIGAS parameter box must be stable before calibration continues, otherwise the monitor cannot obtain a reliable calibration constant, which results in inaccurate measurements.
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5. Press Continue. The monitor displays MULTIGAS Oxygen Cal. in Progress.
6. When the 100%-O2 calibration is complete, the monitor displays the message Remove 100% O2, then Press Continue. Wait for the value in the parameter box to stabilize and then remove the O2 source. 7. Click on Continue. When the calibration is complete, the monitor displays MULTIGAS Oxygen Cal. Accepted and the current date and time appear next to the menu field Last O2 Cal. If the calibration fails, the monitor displays an error message (see page 20 for status messages).
SCIO Setup Scio parameters are displayed in the etCO2*, O2/N2O and Anesthetic Agent and parameter boxes. Each has its own setup menu, described in the following pages. NOTES: !
Some Scio parameter labels are marked by an asterisk (*) to distinguish them from parameters monitored by the etCO2 pod or module.
!
You can display the O2/N2O and agent parameters in a single combined parameter box (see page 15).
etCO2* Monitoring The etCO2* waveform displays the instantaneous CO2 measurements calculated by the Scio module. The etCO2* parameter box displays the current values for: Inspired CO2 (iCO2*) - The level of CO2 in the airway during the inspiration phase. End-tidal CO2 (etCO2*) - The level of CO2 in the airway at the end of expiration. Respiration Rate (RRc*) - The patient’s respiration rate, derived from the etCO2* signal by calculating an average rate over the two most recent breaths.
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Scio Module etCO2* (end-tidal CO2) label and value Alarm limits iCO2 (inspired CO2) label and value
Respiration rate label and value
Alarm limits
Alarm limit (Upper limit only)
NOTE: The monitor does not alarm for etCO2 or inspiratory and expiratory agent limit violations until it has established a valid respiratory rate.
To access the Scio etCO2* setup menu: !
Click on the etCO2* parameter box or
1. Press the Menu fixed key. 2. Click on Patient Setup. 3. Click on Parameters to display a list of available parameters. 4. Click on etCO2*.
Quick Reference Table -- etCO2* Setup Click on the following items to execute etCO2* setup functions: The etCO2* Setup Menu Menu Item
Description
Settings
Scale
Sets etCO2 waveform scale
• 40, 60, 80
Agent Display
Displays a separate Agent parameter box;. Ghosted if the monitor is displaying combined MultiGas parameter box (page 15)
• ON, OFF
Pressure Comp. Sets compensation for ambient atmospheric pressure
• Auto
RRc* Apnea Time
Sets time that the monitor waits before report- • OFF, 10, 15, 20, 25, 30 s ing a cessation of breathing as an apnea event
Apnea Archive
Allows you to store and/or record automatically an alarm event for apnea. You can later review stored alarms on the Event Recall screen.
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• OFF, Record, Store (default), Str./Rec.
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The etCO2* Setup Menu Menu Item
Description
Settings
Auto Zero Delay Delays automatic zeroing for 5 minutes for uninterrupted monitoring. WARNING: Delaying the auto zero may inpact the accuracy of the device. Note: Gas sensors in the Scio module are automatically zeroed and calibrated against room air. During zeroing, the monitor temporarily blanks Scio parameter values. One minute before automatic zeroing, the monitor sounds an attention tone and displays the message Auto zero in 1 minute. etCO2* Alarms
N/A
Accesses etCO2* alarms in Alarm Limits table (see SC 7000/8000/9000XL User’s Guide Chapter 5)
O2/N2O Monitoring The O2 waveform indicates O2 concentrations calculated by the Scio module. The O2 parameter box can display the current concentration values for the following parameters: Inspired O2 (iO2) - The level of O2 in the airway during the inspiration phase Expired O2 (etO2) - The level of O2 in the airway during the expiration phase N2O - The concentration of N2O in the patient’s airway The appearance of the O2 parameter box varies depending on whether or not the N2O display is turned on in the O2 menu. Typical O2/N2O parameter box displays are shown below. Parameter Box
Description ScioModule: N2O display turned off. This module calculates both iO2 and etO2 values.
Scio Module: N2O display turned on. This module calculates both iO2 and etO2 values.
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Scio Module Parameter Box
Description
Notes: The symbol in the parameter box indicates that the O2 lower alarm limit has been set to a value less than 21% (the percentage of O 2 in room air). The O2 parameter box does not show N2O alarm limits because N2O does not alarm.
To access the O2(/N2O) setup menu: !
Click on the O2/N2O parameter box or
1. Press the Menu fixed key. 2. Click on Patient Setup. 3. Click on Parameters to display a list of available parameters. 4. Click on O2.
Quick Reference Table -- O2/N2O Setup Click on the following items to execute O2/N2O setup functions The O2 (/N2O) Setup Menu Menu Item
Description
Settings
MultiGas Parameter
Enables combined MultiGas parame- • ON, OFF ter box display (see SC 7000/8000/ 9000XL User’s Guide Chapter 23)
O2 Scale
Sets O2 waveform scale
N2O Display
• ON, OFF Displays N2O values Notes: This selection is ghosted and not available if the monitor is configured to display a combined Scio parameter box (see page -15). There is no alarm function for N2O and the parameter box does not show N2O alarm limits.
Auto Zero Delay
Delays automatic zeroing for 5 minutes for uninterrupted monitoring (see page 9 for information)
• 50 %, 100 %
N/A
1 Point Cal. 2 Point Cal.
See page 6 for detailed information on calibration functions
Last O2 Cal. O2 Alarms
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Accesses Limits table (see SC 7000/ N/A 8000/9000XL User’s Guide Chapter 5)
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Agent Monitoring You can identify agent waveforms and parameters by color (Halothane--Red; Desflurane--Light blue; Enflurane--Orange; Sevoflurane--Yellow; Isoflurane--Purple). The Agent parameter box shows the inspiratory and end-tidal values for the currently monitored agent. If the module is in automatic agent identification mode (ID Override OFF) and has not yet identified or cannot identify the agent, the Agent parameter box displays Agent?. A question mark also appears next to the identified agent’s label (e.g.. etHal?), if the calculated agent concentration value exceeds the module’s accuracy range for agent monitoring (see Technical Data appendix). WA RN IN G : If the monitor displays a question mark next to an agent’s parameter label, use the displayed agent concentration values with caution.
When the Scio module detects a mix of two or more anesthetic agents, the displayed agent waveform reflects the combined agent concentrations. The color of the waveform represents the agent with the highest level of concentration. If there is a change of the anesthetic agent during monitoring, the parameter box displays a MIXED label and replaces the concentration values with asterisks (***). The mixed label (e.g. HAL-HAL) indicates the agent that has the highest level of concentration. This label will switch to that of the second administerred agent when its concentration exceeds that of the first agent.
MAC Values When the monitor, operating in adult mode, has identified an agent, the parameter box shows a value for the minimum alveolar concentration of the agent (MAC value). WA RN IN G S :
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!
MAC values are merely a guideline based on the anesthetic requirements of an average adult patient. Age and other factors are not taken into account.
!
The monitor’s MAC values cannot be applied to children or neonates.
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Scio Module 1 MAC (minimum alveolar concentration) is equal to the alveolar anesthetic concentration at one atmosphere (760 mmHg) at which 50% of all patients no longer respond to noxious stimuli, and corresponds to the following expiratory agent concentrations. Agent Concentrations (MAC Values) HAL
ENF
ISO
SEV
DES
N2 O
0.75%
1.7%
1.15%
1.7%
6%
100%
The table below shows typical Agent parameter box displays. Parameter Box
Description Agent identified. The monitor is in adult monitoring mode (MAC values displayed).
Agent identified. The monitor is in pediatric or neonatal monitoring mode (no display of MAC values).
Agent not yet identified in automatic identification mode (ID Override OFF).
More than one agent identified. The mixed label (ex. HALHAL) indicates the agent that has the highest level of concentration. This label will switch to that of the second administered agent when its concentration exceeds that of the first agent..
HAL
To access the Agent setup menu: !
Click on any Agent parameter box if displayed or
1. Press the Menu fixed key. 2. Click on Patient Setup. 3. Click on Parameters to display a list of available parameters.
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4. Click on AGENT to display the Agent menu.
Quick Reference Table -- Agent Setup Click on the following items to execute Agent setup functions: The Agent Setup Menu Menu Item
Description
Settings
Agent Scale
Sets Agent waveform scale
• 1, 2, 3, 5, 10, or 20%
Agent Display
Displays a separate Agent parameter box • ON, OFF Note: Ghosted if the monitor is displaying combined MultiGas parameter box (page 15)
ID Override
Configures Scio module to identify an agent automatically or to measure the concentration levels of a user-specified anesthetic agent. Note: The presence of organic cleaning solutions or gases containing freon may impact the accuracy of the Scio module.
Auto Zero Delay Delays automatic zeroing for 5 minutes for uninterrupted monitoring. WARNING: Delaying the auto zero may inpact the accuracy of the device. Note: Gas sensors in the Scio module are automatically zeroed and calibrated against room air. During zeroing, the monitor temporarily blanks Scio parameter values. One minute before automatic zeroing, the monitor sounds an attention tone and displays the message Auto zero in 1 minute. Agent Alarms
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• OFF -- Module automatically identifies agent and displays its concentration levels Manual override selections: • HAL • ISO • ENF • SEV • DES Note: If you select an agent from the ID Override menu that is different from the one actually administered, the monitor displays a message indicating the type of agent it actually detects (i.e. Hal detected). N/A
Accesses Agent alarms in Alarm Limits table (see SC 7000/8000/9000XL User’s Guide Chapter 5)
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Scio Module Combined Display (O2/Agent/N2O) The O2/N2O and Agent parameters can be combined to share a single waveform channel and MultiGas parameter box. Typical combined MultiGas parameter boxes are shown below. Parameter Box
Description The Scio module has identified an agent and displays concentration levels for O2, isoflurane, and N2O.
The Scio module is in automatic agent identification mode (ID Override OFF), but has not yet identified the agent.
To enable the combined MULTIGAS parameter box display: 1. Open the Main Screen setup menu (see SC 7000/8000/ 9000XL User’s Guide page 2-4). 2. Click on More to go to the Main Screen menu’s second page. 3. Select MultiGas Parameter; click the knob to select ON. NOTES: !
You can also enable MultiGas Parameter from the O2 menu (see page 11) or the O2/N2O menu (page 11).
!
The combined MULTIGAS parameter box takes the place of the O2 parameter box on the Main Screen. Make sure that the O2 or the MULTIGAS parameter is appropriately assigned on the parameter priority list (see SC 7000/8000/9000XL User’s Guide Chapter 2).
!
When you select the combined MULTIGAS parameter box, N2O values are automatically enabled for display.
To access the combined (O2/Agent/N2O) setup menu: 1. Ensure that MultiGas Parameter is ON. 2. Return to the Main Screen. 3. Click on the O2/Agent/N2O combined parameter box.
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Quick Reference Table -- Combined Display Setup Click on the following items to execute setup functions for Combined (O2/Agent/N2O) MultiGas monitoring and display. The Combined (O2/Agent/N2O) Setup Menu Menu Item
Description
Settings
Waveform
Selects waveform for display
• O2, Agent
MultiGas Parameter
Enables combined MultiGas parameter box display (see SC 7000/8000/9000XL User’s Guide Chapter 23)
• ON, OFF
O2 Scale
Sets O2 waveform scale (see page 9)
• 50 %, 100 %
N2O Display
Displays N2O values in O2/N2O parame- • ON, OFF ter box (see page 11)
Agent Display
Displays a separate Agent parameter box (see page 14)
• ON, OFF
Note: During the combined display, the N2O and Agent displays are automatically turned on and their selections are ghosted on the combined menu. You can only access these selections and turn the displays off, once you have turned off the combined MultiGas parameter display. Agent Scale
Sets Agent waveform scale
• 1-20 % in increments of 1
ID Override
Configures Scio module to identify an agent automatically as specified by the user (see page 14)
• OFF -- Identifies agent and displays its concentration levels • Override options: HAL ISO ENF SEV DES
Auto Zero Delay
Delays automatic zeroing for 5 minutes (see page 9 for detailed information)
N/A
1 Point Cal. 2 Point Cal.
See page 6 for detailed information on calibration functions.
Last O2 Cal. O2 Alarms
Accesses O2 alarms in the Alarm Limits table (see SC 7000/8000/ 9000XL User’s Guide Chapter 5)
Maintenance and Repair To ensure safety, the Scio module requires routine cleaning (see SC 7000/8000/9000XL User’s Guide Chapter 26, Cleaning, Disinfecting, and Sterilizing). Monitoring accessories such as sam-
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Scio Module pling tubing, T-connectors, water traps, and fan filters are not reusable and need to be replaced at regular intervals. General equipment inspection and maintenance is required. Once a year, check all devices, accessories, and cables for damage and test the ground resistance, chassis and patient leakage currents as well as all alarm functions. Make sure that all safety labels are legible. Maintain a record of these safety inspections. WA RN IN G S : !
Occupational safety: Used sampling tubing, T-connectors and water traps could be contaminated and must be handled and disposed of with care. Infection hazard may be present. Dispose of these items in accordance with local regulations.
!
Because of the danger of electric shock, never remove the cover of any device while it is in operation or connected to a power outlet.
Changing the Sampling Tubing and T-Connector The sampling tubing and T-connector that connect the Scio module to the patient’s airway are not reusable. They must be replaced under the following conditions: !
A new patient is connected to the module
!
The cleanliness of the tubing or connector is suspect or compromised NOTE: Use only Siemens-approved sidestream sampling lines. Siemens does not assume responsibility for the reliability and safety of Scio measurements, if non-approved tubing is used.
Emptying the Water Trap The water trap should be emptied if the contents have reached the ‘full’ mark. NOTE: If water trap has been in use for 1 month, it should be replaced. (See “Replacing the Water Trap” below.)
To empty the water trap:
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1. Disconnect the sampling tubing. 2. Remove the trap from its connector by holding it firmly on the ridged surfaces and pulling it out from the Scio module. 3. Connect an empty syringe (size > 20 ml and without a needle) to the port on the back of the water trap.
4. Aspirate water trap contents into syringe. 5. Remove syringe and discard. NOTE: Do not attempt to clean water trap.
6. Reseat water trap by pressing it against the Scio. A click will indicate that it is seated properly. 7. Reconnect the sampling tubing. (Before monitoring a new patient, exchange the tubing and T-connector, see page 17.)
Replacing the Water Trap To replace the water trap: 1. Disconnect the sampling tubing. 2. Remove the trap from its connector by holding it firmly on the ridged surfaces and pulling it out from the Scio module 3. Insert the new trap by pressing it against the Scio. A click will indicate that it is seated properly. 4. Connect the sampling tubing. (Before monitoring a new patient, exchange the tubing and T-connector, see page 17.)
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