Users Reference Manual
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Datex-Ohmeda S/5 Anesthesia Monitor
User’s Reference Manual
Related to softwares S-00A01, S-00A02, L-00A03 and L-00A04 Monitoring functions
0537
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply. Conformity according to the Council Directive 93/42/EEC concerning Medical Devices
Document No. 8001858-0 October 2000 Datex-Ohmeda Inc. 3 Highwood Drive Tewksbury, MA 01876 Tel. (978) 640-0460 Fax (978) 640-0469 www.us.datex-ohmeda.com
Datex-Ohmeda Division, Instrumentarium Corporation P.O. Box 900, FIN-00031 DATEX-OHMEDA, FINLAND Tel. +358 10 39411 Fax +358 9 1463310 www.datex-ohmeda.com
Datex-Ohmeda S/5 Anesthesia Monitor
NOTICE Intended purpose The Datex-Ohmeda S/5 Anesthesia Monitor with S-00A01, S-00A02, L-00A03 or L-00A04 software is intended for multiparameter monitoring with optional patient care documentation.
Indications for use The Datex-Ohmeda S/5 Anesthesia Monitor with S-00A01, S-00A02, L-00A03 or L-00A04 software is indicated for monitoring of hemodynamic (including arrhythmia and ST segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion and neurophysiological status of all hospital patients. The S/5 Anesthesia Monitor with L-00A03 or L-00A04 software is also indicated for documenting patient care related information. The S/5 Anesthesia Monitor with S-00A01, S-00A02, L-00A03 or L-00A04 software is indicated for use by qualified medical personnel only.
Classifications In accordance with IEC 60601-1 CLASS I EQUIPMENT - the type of protection against electric shock. TYPE BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on each parameter module. EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. CONTINUOUS OPERATION according to the mode of operation. In accordance with IEC 60529 Degree of protection against the harmful ingress of water as detailed in the IEC 60529: IPX0 In accordance with EU Medical Device Directive The Datex-Ohmeda S/5 Anesthesia Monitor is classified as IIb.
Datex-Ohmeda S/5 Anesthesia Monitor
Responsibility of the manufacturer Datex-Ohmeda Division, Instrumentarium Corp. is responsible for the safety, reliability and performance of the equipment only if: −=
assembly, operations, extensions, readjustments, modifications, service and repairs are carried out by personnel authorized by Datex-Ohmeda.
−=
the electrical installation complies with appropriate requirements.
−=
the equipment is used in accordance with the User’s Guide.
Trademarks Datex®, Ohmeda® and other trademarks S/5, Flexima, D-lite, Pedi-lite, D-fend, D-fend+, MemCard, ComWheel, EarSat, FingerSat, FlexSat, PatientO2, Patient Spirometry and Tonometrics are property of Instrumentarium Corp. or its subsidiaries. All other product and company names are property of their respective owners.
Copyright Copyright Instrumentarium Corp. All rights reserved. All specifications subject to change without notice.
Datex-Ohmeda S/5 Anesthesia Monitor
Table of contents
Table of contents ABOUT THIS MANUAL 1.
SAFETY
2.
SYSTEM DESCRIPTION
3.
INTERFACING
4.
MONITORING BASICS
5.
ALARMS
6.
MONITOR SETUP
7.
TRENDS AND SNAPSHOTS
8.
PATIENT DATA MANAGEMENT
9.
RECORDING AND PRINTING
10.
CARE AND CLEANING
11.
TROUBLESHOOTING
12.
ECG
13.
PULSE OXIMETRY
14.
TEMPERATURE
15.
INVASIVE BLOOD PRESSURE
16.
IMPEDANCE RESPIRATION
17.
CARDIAC OUTPUT
18.
MIXED VENOUS OXYGEN SATURATION
19.
NON-INVASIVE BLOOD PRESSURE
20.
AIRWAY GASES
21.
PATIENT SPIROMETRY
22.
GAS EXCHANGE
23.
TONOMETRY
24.
NEUROMUSCULAR TRANSMISSION
25.
EEG AND EP
26.
INDEX
27.
DEFAULT CONFIGURATION WORKSHEET
28.
SUPPLIES AND ACCESSORIES CATALOG
Datex-Ohmeda S/5 Anesthesia Monitor
Table of contents
Table of contents ABOUT THIS MANUAL
1
General... 1 Conventions used... 1 Additional information ... 2 Installation and service... 2 Clinical application ... 2
About this manual
ABOUT THIS MANUAL General This User’s Reference Manual describes the functions offered by the Datex-Ohmeda S/5 Anesthesia Monitor running the software S-00A01, S-00A02, L-00A03 or L-00A04. As the monitor setup may vary, some menus, displays and functions described may not be available in the monitor you are using. NOTE: Before using your Datex-Ohmeda S/5 Anesthesia Monitor, please read the User’s Guide or this manual thoroughly. The User’s Reference Manual gives you more specific information about the clinical and technical aspects. Pay special attention to WARNING and CAUTION statements appearing throughout the manual. The new user of the Datex-Ohmeda S/5 Anesthesia Monitor should begin with chapters Safety and Monitoring basics. These chapters describe the basic operation of the monitor. The measurement chapters describe the measurement technique, setup and how to adjust display and menus for patient monitoring and special views. The Default Configuration Worksheet describes the options and factory default settings of the software.
Conventions used Throughout this manual, the following conventions are used to distinguish procedures or elements of text: ECG
Press the menu key described.
Turn the ComWheel.
Press the ComWheel.
Hard keys
Names of the hard keys on the Command Bar, the Remote Controller and modules are written in the following way: ECG.
Menu Items
Menu items are written in bold italic typeface, for example ECG Setup.
‘Messages’
Messages that are displayed on the screen are enclosed in single quotes, e.g., ‘Please wait.’
Chapters
When refering to different chapters, the chapter name is written in italic typeface, e.g., chapter Cleaning and Care.
WARNING
Warnings are written in bold typeface, for example:
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Datex-Ohmeda S/5 Anesthesia Monitor
WARNING
The 17” display is wall-mountable only. The display must be mounted at 180 cm / 71 inch or higher level to prevent any liquid from entering the display casing.
CAUTION
Cautions are written in the following way:
CAUTION
Do not connect the display version D-VHC17-01 to the 8-Module Frame. The unit may overheat.
Additional information Information Management products are described in: −=
Datex-Ohmeda Central, User’s Reference Manual
−=
Datex-Ohmeda S/5 Anesthesia Record Keeper, User’s Reference Manual
Software options and default settings are described in the S/5 Monitor’s Default Configuration Worksheet included in this manual. We describe sections like circuit diagrams and component part lists in the Schematic Diagrams. Datex-Ohmeda accessories are described in the Datex-Ohmeda Supplies and Accessories catalog included in this manual.
Installation and service A separate Technical Reference Manual describes installation, interfacing, connectors, service, maintenance and reparation procedures of the S/5 Anesthesia Monitor. The installation section covers the following subjects: 1.
8-Module Frame installation
2.
Display installation
3.
Side-Mountable Airway Module installation
4.
S/5 Anesthesia Record Keeper installation
5.
Extension Frame installation
6.
Functional check
Service and reparations are allowed by authorized service personnel only. Chapter Cleaning and care describes cleaning and daily maintenance procedures.
Clinical application Detailed information on clinical applications can be found in several Datex-Ohmeda publications. Datex-Ohmeda produces application guides about patient spirometry, CO2 monitoring, PCWP, cardiac output, ST segment analysis, impedance respiration, etc.
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Table of contents
Table of contents 1 SAFETY
1-1
Safety precautions ...1-1 Warnings ...1-1 Cautions...1-3
Safety
1 SAFETY Safety precautions The following list contains the warnings and cautions you should know before starting to use the system. The measurement sections contain specific precautions.
Warnings WARNING
A WARNING INDICATES A SITUATION IN WHICH THE USER OR THE PATIENT MAY BE IN DANGER OF INJURY OR DEATH. EXPLOSION HAZARD •=
To avoid explosion hazard, do not use the Datex-Ohmeda S/5 Anesthesia Monitor in presence of flammable anesthetics. The monitor measures only non-flammable anesthetics. Halothane, enflurane, isoflurane, sevoflurane, and desflurane are nonflammable anesthetics.
ELECTRICAL SHOCK HAZARD •=
After cleaning or if liquid has accidentally entered the interior of the monitor, make sure that every part of the monitor is dry before reconnecting it to the power outlet.
•=
Before cleaning, disconnect the 8-Module Frame from the power outlet.
•=
Before starting to use the system, ensure that the whole combination complies with the international standard IEC 60601-1-1 and with the requirements of the local authorities.
•=
Do not autoclave any part of the monitor with steam or ethylene oxide.
•=
Do not connect any other external equipment to the system, except that specified by Datex-Ohmeda.
•=
Do not immerse any part of the device in liquids, or allow liquid to enter the interior.
•=
Make sure that external equipment is hospital-grade grounded before connecting.
•=
NMT: Always stop the NMT measurement before handling the stimulation electrodes.
•=
NMT: Do not place the NMT stimulation electrodes on the patient’s chest.
•=
The 15” Video Display line cord is to be connected only to the power outlet of the 8-Module Frame. Connecting it to the mains power will cause the video display leakage current to exceed the limit specified for medical equipment.
•=
The 17” display, D-VHC17, is wall-mountable only. The display must be mounted at 180 cm / 71 in or higher level to prevent any liquid from entering the display casing.
•=
Connect the D-VHC17 display version 02 to the power outlet of the 8-module frame. If the display is connected to the mains power, a separating transformer must be used.
•=
The secondary display must always be supplied from an additional transformer providing at least basic isolation (isolating or separating transformer). Without an appropriate transformer the leakage current of the secondary display can be too high.
•=
Use only hospital-grade grounded electrical outlets and power cord. 1-1
Datex-Ohmeda S/5 Anesthesia Monitor
PATIENT SAFETY •=
All invasive procedures involve risks to the patient. Use the aseptic technique. Follow catheter manufacturer’s instructions.
•=
Always make sure that necessary alarm limits are set and working when you start monitoring.
•=
Connect only one patient to one Datex-Ohmeda S/5 Anesthesia Monitor at a time.
•=
Never install the monitor so that it is above the patient.
•=
Constant attention by a qualified professional is needed whenever a patient is under anesthesia or connected to a ventilator. Some equipment malfunctions may pass unnoticed in spite of the monitor alarm.
•=
Do not use antistatic or electrically conductive breathing tubes. They may increase the risk of burns when electrosurgery unit is utilized.
•=
Do not use B-INT and M-INT at the same time. If both of them are connected, the monitor may disregard information.
•=
Do not use the S/5 Anesthesia Monitor during magnetic resonance imaging (MRI).
•=
C.O.: Do not measure cardiac output during electrosurgery. Erroneous values may result.
•=
ECG, Impedance Respiration, InvBP, C.O., SvO2, EEG: Ensure proper contact of the return electrode of the electrosurgery unit to your patient to avoid possible burns at sensor sites.
•=
ECG, Impedance Respiration, NMT, EEG: Make sure that the lead set clips or snaps do not touch any electrically conductive material including earth.
•=
Gases: Airway Module, G-AO, cannot distinguish between anesthetic agents. Manufacturer assumes no liability for an incorrect anesthetic selection.
•=
Gases: Alcohol in patient’s breath may increase anesthetic agent readings.
•=
Gases: Be aware that MAC values are empirical, not absolute values. The monitor's MAC values correspond to those of healthy adults and cannot be applied to children. Age and some other individual factors influencing the effect of volatile agents are not taken into account.
•=
Impedance Respiration: In obstructive apnea, respiration movements and impedance variations may continue.
•=
InvBP: Make sure that no part of the patient connections touches any electrically conductive material including earth.
•=
NIBP: The monitor sets the inflation pressure automatically according to the first measurement. Reset the case to reset the inflation limit before measuring a new patient.
•=
PATIENTS WITH PACEMAKERS: Do not rely entirely upon rate meter alarms when monitoring patients with pacemakers. The monitor may count the pacemaker pulses as heartbeats. In this case, asystole and ventricular fibrillation may go undetected. Always keep these patients under close surveillance and monitor their vital signs carefully.
•=
PACEMAKER PATIENTS: The impedance respiration measurement may cause rate changes in Minute Ventilation Rate Responsive Pacemakers. Set the pacemaker rate responsive mode off or turn the impedance respiration measurement off on the monitor. 1-2
Safety
•=
SpO2: A damaged sensor or a sensor soaked in liquid may cause burns during electrosurgery.
•=
SpO2: To prevent erroneous readings, do not use physically damaged sensors.
•=
SpO2: Expired sensor life can result in the display of inaccurate SpO2 data. Therefore, always verify unusual data by performing a formal patient assessment.
•=
SpO2: Discard a damaged sensor immediately. Do not repair a damaged sensor or use a sensor repaired by others.
•=
SpO2: Change measuring site frequently. Change sensor site and check skin and circulatory status every 2-4 hours with adults and every hour with small children.
•=
The output signals are not floating and they must not be connected directly to a patient.
•=
The system is indicated for use by qualified medical personnel only.
•=
When the alarms are silenced, observe the patient frequently, depending on the situation.
Cautions CAUTION
A CAUTION INDICATES A SITUATION IN WHICH THE UNIT OR DEVICES CONNECTED TO IT MAY BE DAMAGED. •=
Before connecting the power cord to the power supply, check the local voltage and frequency stated on the device plate on the rear panel of the 8-Module Frame.
•=
Clean rear panel fan dust filters once a month or whenever needed.
•=
Dispose of the whole device, and parts of it, in accordance with local environmental and waste disposal regulations.
•=
Do not apply pressurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.
•=
Do not connect nor disconnect the side-mountable Airway Module during operation.
•=
Do not connect the 17” display version D-VHC17-01, to the 8-Module Frame. The unit may overheat.
•=
Do not force the D-LCC15 display past its maximum extension in either direction.
•=
Make sure that the AC adapter of the D-LCC15 display is plugged into a grounded power outlet. Do not use the adapter in the presence of flammable anesthetics.
•=
Do not disinfect or open the water trap cartridge. Do not touch the water trap membrane. The hydrophobic membrane is damaged if any cleaning is attempted other than rinsing with water.
•=
Do not store the monitor outside the specified temperature range (-10 to + 50°C / 14 to 122 °F).
•=
Do not subject memory cards to excessive heat, bending, or magnetic fields.
•=
Do not use hypochlorite, acetone-, phenol-, or ammonia-based cleaners.
•=
EEG: Do not cover the EEG headbox as it may overheat.
1-3
Datex-Ohmeda S/5 Anesthesia Monitor
•=
Gases: Turn off the monitor and disconnect the power cord from the mains before connecting or disconnecting the side-mountable Airway Module. See the Technical Reference Manual for details.
•=
InvBP: Mechanical shock to invasive blood pressure transducer may cause severe shifts in zero balance and calibration, and produce erroneous readings.
•=
Keep the 8-Module Frame horizontal when the Compact Airway Module is used. Turning may cause erroneous results in the Compact Airway Module’s readings and damage the module.
•=
Leave space for circulation of air to prevent the monitor from overheating.
•=
Strong scavenging suction may change the operating pressure of the monitor and cause inaccurate readings or internal damage.
•=
To prevent any liquid from entering the casing of the 10” LCD display, D-LCC10A, do not tilt the display more than 45 degrees backward or 15 degrees forward. Make sure that the display is not exposed to mechanical shocks.
•=
To prevent any liquid from entering the casing of the 15” LCD display, D-LCC15, do not tilt the display more than ± 20 degrees.
•=
Turn off the power before making any rear panel connections.
•=
Use only cables and accessories approved by Datex-Ohmeda. Other cables and accessories may damage the system or interfere with measurement. Single-use accessories are not designed to be reused.
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Table of contents
Table of contents 2 SYSTEM DESCRIPTION
2-1
Principles of functions ...2-1 Main components ...2-2 Main displays...2-3 15” video display, D-VMC15 ...2-3 15” LCD display, D-LCC15...2-4 10” LCD display, D-LCC10A ...2-5 8-Module frame ...2-6 Rear of the 8-Module frame...2-7 Module overview ...2-9 Compact airway modules ...2-10 Side-mountable airway modules...2-10 Other modules ...2-11 Avoiding identical modules...2-11 General module description ...2-12 Optional products...2-14 Anesthesia Record Keeper and keyboard ...2-14 Extension frame ...2-15 21" display ...2-16 17” display ...2-17 Remote Controller ...2-18 Symbols and abbreviations...2-19 Equipment safety symbols...2-19 Other equipment symbols...2-20 15” video display control symbols...2-21 15” LCD display control symbols...2-22 17” display control symbols ...2-22 Abbreviations...2-23 Specifications ...2-30
System description
2 SYSTEM DESCRIPTION Principles of functions The S/5 Anesthesia Monitor is a modular multiparameter patient monitor. The monitor is especially designed for anesthesia monitoring. The modular design makes the system flexible and easy to upgrade. In addition to parameter upgrades, the modularity includes an easy upgrade to anesthesia record keeping, monitor networking and interfacing with external devices.
2-1
Datex-Ohmeda S/5 Anesthesia Monitor
Main components The Datex-Ohmeda S/5 Anesthesia Monitor may consist of the elements shown below.
3
4
2
1
5
9
10
7 8 6 11
12
Figure 2-1
WARNING
Datex-Ohmeda S/5 Anesthesia Monitor
(1)
15” Main Display, D-VMC15
(2)
15” LCD Display, D-LCC15
(3)
10” LCD Display, D-LCC10A
(4)
21" Video display, D-VSC21
(5)
17” Video Display, D-VHC17
(6)
Printer
(7)
Extension Frame, F-EXT4
(8)
Extension module, M-EXT
(9)
Remote Controller, K-REMCO
(10)
8-Module Frame, F-CU8
(11)
Modules
(12)
S/5 Anesthesia Record Keeping Keyboard, K-ARKB
Connect only one patient to one Datex-Ohmeda S/5 Anesthesia Monitor at a time.
2-2
System description
Main displays There are two options for main display: a 15" color video display and a 15" color LCD display. The main displays show up to eight (8) waveforms, real-time data and trends. The Command Bar, K-ANEB, is used to make adjustments in the display and monitored parameters, silence the alarms, and reset the monitor to default settings. NOTE: It is recommended not to use more than three (3) Command Bars or keyboards in the same system simultaneously. The warm-up time of the monitor may be extended.
15” video display, D-VMC15
1
2 3 Figure 2-2
4
5
15” video display
(1)
Video Display, D-VMC15
(2)
Command Bar
(3)
Command Bar keys
(4)
ComWheel
(5)
ON/STBY switch
2-3
Datex-Ohmeda S/5 Anesthesia Monitor
15” LCD display, D-LCC15 With the LCD Display, D-LCC15, you can bring the desired information and Command Bar right near to the patient.
1 2
7
3 4
6
Figure 2-3
5
LCD display
(1)
15” LCD display, D-LCC15
(2)
Display control buttons (see the display manual for further information)
(3)
ON/STBY switch of the monitor
(4)
ComWheel
(5)
Desk stand option
(6)
Signal cable
(7)
Command Bar keys
When using the display with the desk stand option, it must be placed on a flat surface that is horizontal to ±5°. To use the LCD Display, you need a Display Controller Board, B-DISP. The display can be used on XGA resolution only.
CAUTION
To prevent any liquid from entering the LCD display casing, do not tilt the LCD display more than ±20 degrees.
CAUTION
Do not force the display past its maximum extension (5° forward, 25° backward with desk stand option) in either direction.
CAUTION
The LCD Display is fragile. Ensure that the LCD Display is not exposed to mechanical shocks or constant direct sunlight.
2-4
System description
10” LCD display, D-LCC10A With the LCD Display, D-LCC10A, you can bring the desired information right near to the patient.
6
1
5
2 4
Figure 2-4
3
LCD display
(1)
10” LCD display, D-LCC10A
(2)
Connector for Datex-Ohmeda S/5 Anesthesia Record Keeping Keyboard, K-ARKB, or Remote Controller, K-REMCO, or Barcode Reader
(3)
ON/STBY switch
(4)
ComWheel
(5)
Command Board keys
(6)
Display Arm
To use the LCD Display, you need a Display Controller Board, B-DISP. The display can be used on VGA resolution only.
CAUTION
To prevent any liquid from entering the LCD display casing, do not tilt the LCD display more than 45 degrees backward or 15 degrees forward.
CAUTION
The LCD Display is fragile. Ensure that the LCD Display is not exposed to mechanical shocks.
2-5