S5 Compact Anaesthesia Monitor Users Reference Manual June 2002

Datex-Ohmeda S/5 Compact Anesthesia Monitor User's Reference Manual Related to software licenses L-CANE02 and L-CANE02A Monitoring functions

0537

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices. CAUTION: US Federal law restrict 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. All specifications are subject to change without notice. Document No. 8002530-0 June 2002 Datex-Ohmeda Inc. P.O. Box 7550 Madison, WI 53707-7550, USA Tel: +1-608-221 1551 Fax: +1-608-222 9147 www.us.datex-ohmeda.com

Datex-Ohmeda Division, Instrumentarium Corporation P.O. Box 900 FIN-00031 Datex-Ohmeda Tel. +358 10 39411 Fax +358 9 146 3310 www.datex-ohmeda.com © Instrumentarium Corp. All rights reserved.

Intended purpose (Indications for use) The Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 or L-CANE02A software is intended for multiparameter patient monitoring with optional patient care documentation. The Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 or L-CANE02A 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 Compact Anesthesia Monitor with L-CANE02 or L-CANE02A software is also indicated for documenting patient care related information. The S/5 Compact Anesthesia Monitor with L-CANE02 or L-CANE02A software is also indicated for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals. The Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 or L-CANE02A 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 IPX1 - the degree of protection against the harmful ingress of water. In accordance with EU Medical Device Directive The Datex-Ohmeda S/5 Compact 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+, Mini D-fend, D-fend, D-fend+, TruTrak®+, OxyTip+, 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.

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. MAGNETIC RESONANCE IMAGING (MRI) 28. INDEX 29. DEFAULT CONFIGURATION WORKSHEET 30. 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 Compact Anesthesia Monitor running the software license L-CANE02 or L-CANE02A. 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 Compact 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 Compact Anesthesia Monitor should begin with sections "Safety," "System description" and "Monitoring basics." These section describe the system and the basic operation of the monitor. The measurement sections describe the measurement technique, setup and how to adjust displays 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 Board and modules are written in the following way: Cancel. 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 1 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 Anesthesia 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 Compact Anesthesia Monitor

CAUTION

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

ECG

Turn the ComWheel.

Press the ComWheel.

Additional information Information Management products are described in: −

"Datex-Ohmeda S/5 Central, User’s Reference Manual"

−

"deioRecorder for Anesthesia, User’s Reference Manual"

−

"Datex-Ohmeda S/5 Arrhythmia Workstation User's Reference Manual."

Software options and default settings are described in the S/5 Monitor’s "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 Compact Anesthesia Monitor. Service and reparations are allowed by authorized service personnel only. Section "Cleaning and care" describes cleaning and daily maintenance procedures. Installation and service of the Datex-Ohmeda S/5 LAN Network is described in the "Datex-Ohmeda S/5 Central and Network Technical Reference Manual." Installation of the Datex-Ohmeda S/5 WLAN Network is described in the "Datex-Ohmeda S/5 Network, Wireless LAN Installation Guide."

Clinical application Detailed information on clinical applications can be found in several Datex-Ohmeda publications. Datex-Ohmeda produces application guides, for example, about patient spirometry, CO2 monitoring, PCWP, cardiac output, ST segment analysis and impedance respiration.

2

Table of contents

Table of contents 1 Safety

1–1

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

Safety

1 Safety Safety precautions The following list consists all the general warnings and cautions that 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 Compact 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 the 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.

•

Never install the monitor so that it is above the patient.

•

Do not use the S/5 Compact Anesthesia Monitor during magnetic resonance imaging (MRI) unless you use the MRI shield (N-MRI) together with the MRI compatible modules (M-MRI or M-RIP) and accessories.

•

Keep the monitor horizontal when the Compact Airway Module is used. Tilting the monitor may cause erroneous results in the Compact Airway Module’s readings and damage the module.

•

If the integrity of the external protective earth conductor arrangement is in doubt, use the monitor with battery operation.

•

Do not touch battery operated monitor during defibrillation procedure.

•

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

•

The system is intended for use by qualified medical personnel only.

1–1

Datex-Ohmeda S/5 Compact Anesthesia Monitor

Cautions CAUTION

A CAUTION indicates a situation in which the unit or 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.

•

Vibrations during transport may disturb SpO2, ECG, impedance respiration and NIBP measurements.

•

Leave space for circulation of air 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.

•

Refresh the batteries completely once a month.

•

Other transmitting radio devices using the same radio frequency band (Industrial Scientific and Medical 2.45 GHz band) may degrade or disturb the wireless network communication.

Disposal Dispose of the whole device and parts of it in accordance with local environmental and waste disposal regulations.

1–2

Table of contents

Table of contents 2 System description

2–1

Principles of functions... 2–1 System introduction... 2–1 Components... 2–2 Main components ... 2–2 Optional components ... 2–3 Measurements in MRI environment... 2–4 Communication between monitors ... 2–4 Compact Anesthesia Monitor connections ... 2–5 Module overview... 2–6 Compact airway modules, Single-width Airway Module ... 2–7 Other modules... 2–7 Avoiding identical modules ... 2–7 General module description ... 2–8 Internal battery ... 2–10 Battery time ... 2–10 Refreshing the batteries ... 2–10 Symbols and abbreviations ... 2–11 Equipment safety symbols ... 2–11 Other equipment symbols ... 2–12 Abbreviations ... 2–13 Specifications... 2–27 Power supply... 2–27 Battery operation... 2–27 Environmental conditions ... 2–27 Wireless Network Option, N-CMW ... 2–27 Hemodynamic Modules M-NE(12)STPR, M-NE(12)TPR, M-NE(12)STR, M-ESTPR, M-ETPR, M-ESTR, M-P, MPT, M-NIBP... 2–27 Cardiac Output Modules, M-COP and M-COPSv... 2–28 Compact Airway Modules, M-C, M-CO, M-COV, M-CAiO, M-CAiOV, M-CAiOVX... 2–28 Compact Airway Modules, M-C, M-CO, M-COV, M-CAiO, M-CAiOV, M-CAiOVX (cont.)... 2–29 Single-width Airway Module, M-miniC... 2–29 Nellcor Compatible Saturation Module, M-NSAT ... 2–30 Datex-Ohmeda Compatible Saturation Module, M-OSAT ... 2–30 Neuromuscular Transmission Module, M-NMT ... 2–30 Tonometry module, M-TONO ... 2–30 EEG module, M-EEG ... 2–30 BIS Module, M-BIS ... 2–31

System description

2 System description Principles of functions The S/5 Compact Anesthesia Monitor is a modular multiparameter patient monitor. The monitor is especially designed for anesthesia monitoring. It can also be used during transportation within the hospital. The true modular design makes the system flexible and easy to upgrade. In addition to patient parameter modularity, the monitor can be upgraded to anesthesia record keeping, wired and wireless networking and memory card operation. External devices can be interfaced to the monitor with interface modules.

System introduction

1

3

2

5

4

(1)

S/5 Compact Anesthesia Monitor with modules inside

(2) (3) (4) (5)

Remote Controller, K-CREMCO Printer Datex-Ohmeda S/5 Network (WLAN) Datex-Ohmeda S/5 Network (LAN)

NOTE: Your system may not include all these components.

2–1

Datex-Ohmeda S/5 Compact Anesthesia Monitor

WARNING

Never install the monitor so that it is above the patient.

WARNING

Connect only one patient to the monitor at a time.

WARNING

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

WARNING

Before starting to use the system, ensure that the whole combination complies with the international standard IEC 60601-1-1 and the requirements of the local authorities. Do not connect any external devices to the system other than those specified by Datex-Ohmeda.

CAUTION

The monitor display is fragile. Ensure that it is not exposed to mechanical shocks or constant direct sunlight.

Components

Main components The main components of the Datex-Ohmeda S/5 Compact Anesthesia Monitor are the monitor frame and the interchangeable modules.

Figure 2-1

Datex-Ohmeda S/5 Compact Anesthesia Monitor

The Compact Anesthesia Monitor houses four single-width modules, two double-width modules, or one double-width module and two single-width modules. NOTE: After transferring or reinstalling the monitor, always check that it is properly connected and securely attached.

2–2

System description

Optional components Optional components are: • Built-in recorder • Remote Controller • Keyboard for deioRecorder for Anesthesia for anesthesia record keeping, and Barcode Reader • Wireless network option, N-CMW Possible software options for the Compact Anesthesia Monitor are: • •

Network option, N-CMNET Network and MemCard option, N-CMMEM

NOTE: Memory Module, M-MEM, is not compatible with the S/5 Compact Anesthesia Monitor. NOTE: Insert the WLAN PC card in the first PC card slot from the front.

Remote Controller The Remote Controller, K-CREMCO, brings the Command Board functions near to you and gives access to the same menus as the Command Board. The Remote Controller has keys which start or end a function immediately, like module keys. These direct access keys help you in most common situations and tasks.

Take Snapshot

Special

Start C.O.

Silence Alarms

Zero ALL Pressures

Start Wedge

Freeze Menu

Figure 2-2

Record Wave Other Patients

Start NIBP

Normal Screen

The Remote Controller, K-CREMCO

2–3

Datex-Ohmeda S/5 Compact Anesthesia Monitor

deioRecorder for Anesthesia and keyboard With the L-CANE02 and L-CANE02A software license and deioRecorder for Anesthesia you can: −

automatically record patient’s vital signs during anesthesia

−

print legible records

−

enter gas and ventilation data, laboratory data, fluid data, drug data, events, free comments and postoperative instructions

The deioRecorder keyboard cable is attached to the connector for external keyboard, K-CREMCO and Barcode Reader on the right side of the monitor frame. 4

3 2 1

Figure 2-3

Keyboard for deioRecorder for Anesthesia

(1)

Letter and number keys (alphanumeric keys)

(2)

deioRecorder for Anesthesia function keys

(3)

S/5 Command Board

(4)

ComWheel

Measurements in MRI environment Use the N-MRI1 shield with modules M-MRI and M-MRIP to measure ECG, NIBP, pulse oximetry and invasive pressures, and the N-MRI1 shield with Compact Airway Modules to measure airway gases. For more information, see section "MRI." NOTE: Use only MRI compatible accessories.

Communication between monitors You can use the Compact Monitor as a stand-alone monitor or for - -

viewing and receiving data (alarms, vital signs) from other patient monitors gathering and storing data during transportation.

To view other patient monitors, the monitor needs to be connected to the Datex-Ohmeda S/5 Network (LAN or WLAN). To gather, store, and transfer data between different Datex-Ohmeda monitors, use memory cards or connect the monitor to S/5 Network. NOTE: With WLAN, use only Data Card.

2–4

System description

Compact Anesthesia Monitor connections 11

11 14 1

10

9

13

2 8

3

12

4 5 7 6

Figure 2-4

S/5 Compact Anesthesia Monitor connections

(1)

Air filter

(2)

Recorder (optional)

(3)

For future use

(4)

SYNC connector

(5)

Connector for external keyboard (deioRecorder keyboard), K-CREMCO or Barcode Reader

(6)

Potential equalization

(7)

Serial port

(8)

Receptacle for power cord

(9)

NET ID connector (not used with N-CMW)

(10)

NET connector

(11)

Slot for Memory Cards (PCMCIA) and WLAN PC card

(12)

Connector for Device Interfacing Solution

(13)

WLAN PC card led

(14)

WLAN PC card

NOTE: Insert the WLAN PC card in the first PC card slot from the front.

2–5

Datex-Ohmeda S/5 Compact Anesthesia Monitor

Module overview You can use same modules in the Anesthesia Monitor, Compact Anesthesia Monitor, Critical Care Monitor and Compact Critical Care 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: An 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 the number of 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 *

M-NE12STPR M-NETPR

*

M-NE12TPR

*

2

*

*

up to 12 leads

2

*

2

*

*

up to 7 leads

2

2

*

*

up to 12 leads

2

2

*

*

*

2

*

*

up to 12 leads

*

2

*

*

Temp. Cardiac output/REF

SvO2 Relaxation

*

Invasive pressure

2

up to 7 leads

M-NESTR M-NE12STR

up to 7 leads

M-P

1

M-PP

2

M-PT

1

M-COP

1

*

M-COPSv

1

*

Plexus stimul.

EEG

AEP

*

*

Gastric tonometry

BIS

2

*

M-NMT

*

M-EEG M-TONO

*

*

M-BIS

*

2–6

System description

Compact airway modules, Single-width Airway Module

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

O2

Anesthetic agents

Agent identification

Patient spirometry

CO2

N2O

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

Gas exchange

*

*

*

Other modules You can also use the following modules: - -

Interface Module, M-INT Recorder Module, M-REC. If the monitor already has a built-in recorder, you cannot use the M-REC. In addition, M-REC cannot be used with certain Compact Monitor versions. If it does not work with your monitor, please contact service personnel for upgrade.

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

Select one of the following modules:

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

M-NE(12)STPR, M-NE(12)TPR, M-NE(12)STR, M-ESTPR, METPR, 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.

NIBP (N)

M-NIBP, M-NE(12)STPR, M-NE(12)TPR, 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), automatic anesthetic agent identification (i), gas exchange (X)

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

Tonometry (PgCO2)

M-TONO

NMT

M-NMT

EEG, AEP

M-EEG

Bispectral index

M-BIS

2–7

Datex-Ohmeda S/5 Compact Anesthesia Monitor

General module description The modules are plugged in the Compact Anesthesia Monitor frame. They can be removed or inserted during monitoring. All modules have some common parts, which are shown below: 1

2 3

4

Figure 2-5

General module description

(1)

Insertion guide slot

(2)

Module keys

(3)

Cable connectors

(4)

Module release latch

2–8

System description

Inserting and removing a module insertion quide

module release latch

Figure 2-6

Inserting and removing a module

To insert a module: 1.

Align the module with the insertion guide.

2.

Push the module into the frame until it clicks.

To remove a module: 1.

Press the release latch on the bottom left hand side of the module.

2.

Pull the module out of the frame.

2–9