S5 Anesthesia Monitor Users Reference Manual July 2002

Intended purpose (Indications for use) The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 or L-ANE02A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*. (*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A software is also indicated for documenting patient care related information. The S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A 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 IPX0 - the degree of protection against the harmful ingress of water In accordance with EU Medical Device Directive The Datex-Ohmeda S/5 Anesthesia Monitor is classified as IIb.

Responsibility of the manufacturer Datex-Ohmeda Division, Instrumentarium Corporation is responsible for the effects on safety, reliability and performance of the equipment only if:

•

assembly, extensions, readjustments, modifications, servicing and repairs are carried out by personnel authorized by Datex-Ohmeda.

•

the electrical installation of the monitor room complies with appropriate requirements.

•

the equipment is used in accordance with the "User's Guide."

Trademarks Datex®, Ohmeda®, and other trademarks S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, TruTrak®+, OxyTip+, MemCard, ComWheel, ComBar, 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.

Table of contents

Table of contents ABOUT THIS MANUAL 1.

SAFETY

2.

SYSTEM DESCRIPTION

3.

MONITORING BASICS

4.

INTERFACING

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. BISPECTRAL INDEX 27. INDEX 28. DEFAULT CONFIGURATION WORKSHEET 29. SUPPLIES AND ACCESSORIES CATALOG

1

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 license L-ANE02 or L-ANE02A. 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 Part I and Part II 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 sections "Safety," "System description" and "Monitoring basics." These sections describe the system and the basic operation of the monitor. The measurement sections describe the measurement technique, setup and how to adjust display and menus for patient monitoring and special views. The "Monitor setup" section gives instructions about setting up the system and making changes in the default settings. The "Default Configuration Worksheet" describes the options and factory default settings of the software.

Conventions used To help you find and interpret information easily, the manual uses consistent text formats for certain text types:

WARNING

-

Names of the hard keys on the Remote Controller, Command Bar and modules are written in the following way: Others.

-

Menu items are written in bold italic typeface: Lab Data.

-

Menu access is described from top to bottom. For example, the selection of the Monitor Setup hard key, the Screen Setup menu item and the Waveform Fields menu item would be shown as Monitor Setup - Screen Setup - Waveform Fields.

-

Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Learning’.

-

When referring to different sections in this manual, section names are written in italic typeface and enclosed in double quotes: “Cleaning and Care”.

-

When referring to other manuals, the manual names and section names are written in italic typeface and enclosed in double quotes: “Datex-Ohmeda S/5 Critical Care Monitor User’s Reference Manual: Cleaning and Care”.

-

Warnings are written in bold typeface, for example:

Connect only one patient to a monitor at a time. -

Cautions are written in the following way:

1

Datex-Ohmeda S/5 Anesthesia Monitor

CAUTION

Turn off the power before making any rear panel connections The following symbols are also used to distinguish procedures:

ECG

Press the menu key described.

Turn the ComWheel.

Press the ComWheel.

Additional information For more information about the Datex-Ohmeda S/5 Central, S/5 Arrhythmia Workstation and Anesthesia Record Keeping Solution, see the "User’s Reference Manuals" for these products. Software options and default settings are described in the "Default Configuration Worksheet" included in this manual. Datex-Ohmeda accessories are described in the Datex-Ohmeda "Supplies & 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. Service and reparations are allowed by authorized service personnel only. Section "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.

2

Table of contents

Table of contents 1 Safety

1–1

Safety precautions... 1–1 Warnings... 1–1 Cautions ... 1–1 Disposal... 1–2

Safety

1 Safety Safety precautions The following list contains all the general warnings and cautions you should know before starting to use the system. Warnings and cautions specific to parts of the system can be found in the relevant section.

Warnings WARNING

A WARNING indicates a situation in which the user or the patient may be in danger of injury or death. •

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.

•

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 connect any external devices to the system other than those specified by DatexOhmeda.

•

Connect only one patient to a monitor at a time.

•

Use only hospital-grade grounded power outlets and power cord.

•

Some equipment malfunctions may not generate a monitor alarm. Always keep the patient under close surveillance.

•

Do not use the monitor in high electromagnetic fields (for example, during MRI).

•

If the unit fails to respond as described, do not use the monitor until tested and repaired by authorized service personnel.

Cautions CAUTION

A CAUTION indicates a situation in which the unit or the devices connected to it may be damaged. •

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.

•

Before connecting the power cord to the power supply, check that the local voltage and frequency correspond with the rating stated on the device plate on the rear panel of the monitor.

•

Turn off the power before making any rear panel connections.

•

Leave space for air circulation to prevent the monitor from overheating.

•

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.

1–1

Datex-Ohmeda S/5 Anesthesia Monitor

Disposal •

Dispose of the whole device and parts of it in accordance with local environmental and waste disposal regulation

1–2

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 Central Unit ... 2–6 Rear of the Central Unit... 2–7 Module overview... 2–9 Measurement modules... 2–9 Compact airway modules... 2–10 Other modules ... 2–10 Avoiding identical modules ... 2–10 General module description ... 2–11 Optional products ... 2–13 Extension frame... 2–13 19” LCD display, D-LCC19 ... 2–14 21" display... 2–15 17” display ... 2–16 Remote Controller ... 2–17 Symbols and abbreviations ... 2–18 Equipment safety symbols ... 2–18 Other equipment symbols ... 2–19 15” video display control symbols... 2–20 15” LCD display control symbols ... 2–21 17” display control symbols... 2–21 Abbreviations... 2–23 Specifications... 2–35 Power supply... 2–35 Environmental conditions ... 2–35 Hemodynamic Modules M-NE12STPR, M-NESTPR, M-NE12TPR, M-NETPR, M-NE12STR, M-NESTR, M-ESTPR, M-ETPR, M-ESTR, M-P, M-PP, M-PT; M-NIBP ... 2–35 Cardiac Output Modules, M-COP and M-COPSv... 2–36 Compact Airway Modules, M-C, M-CO, M-COV, M-CAiO, M-CAiOV, M-CAiOVX... 2–36 Compact Airway Modules, M-C, M-CO, M-COV, M-CAiO, M-CAiOV, M-CAiOVX (cont.)... 2–37 Neuromuscular Transmission Module, M-NMT ... 2–37 Nellcor Compatible Saturation Module, M-NSAT ... 2–38 Datex-Ohmeda Compatible Saturation Module, M-OSAT ... 2–38 Tonometry module, M-TONO ... 2–38 EEG module, M-EEG ... 2–38 BIS Module, M-BIS ... 2–38

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 true modular design makes the system flexible and easy to upgrade. In addition to patient parameter modularity and easy upgrades, the monitor can be upgraded to anesthesia record keeping and monitor networking. External devices can be interfaced to the monitor with interface modules.

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

Datex-Ohmeda S/5 Anesthesia Monitor

(1)

15” video display, D-VMC15

(2)

15” LCD display, D-LCC15

(3)

10” LCD display, D-LCC10A

(4)

19" LCD display, D-LCC19

(5)

17” video display, D-VHC17; wall-mountable only

(6)

Printer

(7)

Extension Frame, F-EXT4

(8)

Extension module, M-EXT

(9)

Remote Controller, K-REMCO

(10)

Central Unit, F-CU8 (also called 8-Module Frame)

(11)

Measurement modules

(12)

Anesthesia record keeping solution keyboard

2–2

System description

CAUTION

The displays must only be used together with the original type of power adapter.

WARNING

Connect only one patient to the monitor at a time.

WARNING

A secondary display and printer must be supplied from an additional transformer providing at least basic isolation (isolating or separating transformer).

WARNING

Never install the monitor or the displays so that they are above the patient.

WARNING

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 connect any external devices to the system other than those specified by Datex-Ohmeda.

Main displays 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.

15” video display, D-VMC15 With the 15" video display, D-VMC15, the desired information and Command Bar can be brought conveniently near to the patient.

1

2 3

Figure 2-2

4

5

15” video display

(1)

Video display, D-VMC15

(2)

Command Bar (detachable)

(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, the desired information and Command Bar can be brought conveniently near to the patient.

1

2

7

3 4

6 5

Figure 2-3

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.

WARNING

The 15” display, D-LCC15, must only be used together with the original D-LCC15 power adapter.

CAUTION

To prevent any liquid from entering the LCD display casing, do not tilt the LCD display more than ±20°.

CAUTION

Do not force the display past its maximum extension (6° forward, 20° backward with desk stand option) in either direction.

CAUTION

The LCD display is fragile. Ensure that the LCD display is not placed near a heat source or exposed to mechanical shocks, pressure, moisture, or direct sunlight.

2–4

System description

10” LCD display, D-LCC10A

6

1

5

2 4

Figure 2-4

3

LCD display

(1)

10” LCD display, D-LCC10A

(2)

Connector for the anesthesia record keeping solution keyboard, or Remote Controller, K-REMCO, or Barcode Reader, N-SCAN

(3)

ON/STBY switch

(4)

ComWheel

(5)

Command Bar 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 placed near a heat source or exposed to mechanical shocks, pressure, moisture, or direct sunlight.

2–5

Datex-Ohmeda S/5 Anesthesia Monitor

Central Unit The Central Unit (8-Module Frame) houses up to eight modules. It accepts patient data from the modules and formats it for the display. Using the connector in the rear, data and waveforms are sent to the display or other peripherals.

1

Figure 2-5

2

Central Unit

(1)

Insertion guide

(2)

Module connector

2–6

System description

Rear of the Central Unit

8

9

10

1

11

13

16

2 21 !

18 20

3

4

6

7 5

Figure 2-6

12

19 14

15

17

Rear of the Central Unit

(1)

Receptacle for power cord and fuses

(2)

Power outlet for 15” video display unit (CRT)

(3)

Equipotential connector

(4)

Service reset button

(5)

Network board B-UPI4NET

(6)

Parallel printer port

(7)

RS-232 output

(8)

Direct ECG output

(9)

Network connector

(10)

Identification plug

(11)

Connector for the Device Interfacing Solution, DIS

(12)

CPU Board, B-CPU5, which contains the software and a PC card connector. The cover plate can be moved when updating the software with a PC card.

(13)

Connector for future use

(14)

Display controller board, B-DISP

(15)

Display connector

(16)

Connector for Command Bar/keyboard

(17)

Board for anesthesia record keeping solution

(18)

Connector for the anesthesia record keeping solution keyboard

2–7

Datex-Ohmeda S/5 Anesthesia Monitor

(19)

Interface Board, B-INT

(20)

Serial communication connector

(21)

Module bus connector

Your Central Unit may not have all these boards and the boards may be in different places. With the L-ANE02 or L-ANE02A software license and display board B-DISP (rev. 01) also a third display controller board (for screen 3) is possible. A third B-DISP replaces one of the other boards. The installation and connections are more thoroughly explained in the "Technical Reference Manual."

2–8

System description

Module overview You can use same modules in the Critical Care Monitor, Compact Critical Care Monitor, Anesthesia Monitor and Compact Anesthesia Monitor. The patient accessories for the modules are the same as well. Most of the modules contain several parameters. The following tables show the parameters for each module. NOTE: The asterisk (*) in the parameter column indicates that the module measures the parameter referred to in the column heading. A number in the parameter column indicates that module measures the parameter referred to in the column heading and the number of module connectors for that specific parameter.

Measurement modules 12-lead ECG

ECG

Invasive pressure

SpO2

Temperature

*

2

*

2

*

2

*

M-ESTPR

up to 7 leads

2

M-ETPR

up to 7 leads

2

M-ESTR

up to 7 leads

*

NIBP

M-NIBP

Impedance respiration

*

M-NESTPR

up to 7 leads

2

*

2

*

*

M-NE12STPR

up to 12 leads

2

*

2

*

*

M-NETPR

up to 7 leads

2

2

*

*

M-NE12TPR

up to 12 leads

2

2

*

*

*

*

M-NESTR M-NE12STR

*

Invasive pressure

up to 7 leads

*

2

*

*

up to 12 leads

*

2

*

*

Temp. Cardiac Output/REF

M-P

1

M-PP

2

M-PT

1

M-COP

1

*

M-COPSv

1

*

SvO2 Relaxation

Plexus stimul.

EEG

AEP

*

*

Tonometry

BIS

2

*

M-NMT

*

M-EEG M-TONO

*

*

M-BIS

*

2–9

Datex-Ohmeda S/5 Anesthesia Monitor

Compact airway modules O2

Anesthetic agents

Agent identification

Patient Spirometry

CO2

N2O

M-C

*

*

M-CO

*

*

*

M-COV

*

*

*

M-CAiO

*

*

*

*

*

M-CAiOV

*

*

*

*

*

*

M-CAiOVX

*

*

*

*

*

*

Gas Exchange

*

*

Other modules You can also use the following modules: Recorder Module, M-REC, Memory Module, M-MEM, and the Interface Module, M-INT. You can also use a blank module, M-BLANCO, to fill the empty spaces of the frame without adding parameters.

Avoiding identical modules Modules that measure the same parameter are considered identical. Do not use them in the same monitor simultaneously. To monitor:

Select only one of the following modules:

ECG (E), SpO2 (S), Temp (T), Pressure (P) or Resp (R)

M-NE(12)STPR, M-NE(12)TPR, M-NE(12)STR, M-ESTPR, M-ETPR, M-ESTR, M-ESTP, M-EST, or M-ETP. NOTE: M-ESTP rev. 01, M-EST rev. 00 and M-ETP rev. 00 work only with S-STD93, S-STD94, S-ARK94, S-STD95, S-ARK95, S-STD96 and S-ARK96 software.

NIBP (N)

M-NIBP, M-NE(12)STPR, M-NE(12)TPR or M-NE(12)STR

Pressure (P)

M-P, M-PP or M-PT

Separate pulse oximetry measurement

M-OSAT or M-NSAT

C.O. (CO), Pressure (P) or SvO2 (Sv)

M-COP or M-COPSv

CO2 and N2O (C), O2 (O), Spirometry (V), anesthetic agents and nitrous oxide (A), agent identification (i), gas exchange (X)

M-C, M-CO, M-COV, M-CAiOVX, M-CAiOV, M-CAiO

Tonometry (PgCO2)

M-TONO

NMT

M-NMT

EEG, AEP

M-EEG

Bispectral index

M-BIS

2–10