AS3 Compact Anesthesia Monitor upgraded with U-LIFE2 Part I

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Datex-Ohmeda AS/3 Compact Anesthesia Monitor upgraded with U-LIFE2 User’s Guide Part I: For Monitor Setup and Reference Related to software licenses L-ANE02 and L-ANE02A 053 7

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices 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. All specifications subject to change without notice. Document no. 8004780-0 August 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, FINLAND Tel: +358 10 39411, fax: +358 9 1463310 www.datex-ohmeda.com/

1 The AS/3 Compact Anesthesia Monitor with L-ANE02 or 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 AS/3 Compact 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 AS/3 Compact Anesthesia Monitor with L-ANE02 or L-ANE02A software is also indicated for documenting patient care related information. The AS/3 Compact Anesthesia Monitor with L-ANE02 or L-ANE02A software is indicated for use by qualified medical personnel only.

About this guide This User’s Guide describes the most common features and functions offered by the Datex-Ohmeda Compact Anesthesia Monitor. Descriptions refer to S/5 licenses L-ANE02 and L-ANE02A. If you are a new user of the monitor, we suggest you begin with sections "Safety”, “System introduction" and "Monitoring basics". The following conventions are used: Names of the hard keys on the Command Board, Remote Controller and modules are written in the following way: ECG. Menu items are written in bold italic typeface, for example ECG Setup Menu access is described from top to bottom. For example, the selection of the Screen Setup menu item and the Waveform Fields menu item would be shown as Screen Setup - Waveform Fields. Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes, for example ‘Learning’. When referring to different sections in this manual, section names are written in italic typeface and enclosed in double quotes, for example “Cleaning and Care.” In this manual, the word “select” means choosing and confirming.

Classifications In accordance with IEC 60601-1: -

Related documentation

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Clinical aspects and technical background: S/5 Compact Anesthesia Monitor, User’s Reference Manual Instructions for daily use: AS/3 Compact Anesthesia Monitor upgraded with U-LIFE2, User's Guide Part II Technical solutions and servicing: AS/3 and CS/3 Compact Monitor upgraded with U-LIFE2, Technical Reference Manual; S/5 Modules, Technical Reference Manual. Options and selections of the software: Default Configuration Worksheet Circuit diagrams, component part lists, etc.: Schematic Diagrams Other devices closely related to the Compact Anesthesia Monitor: Datex-Ohmeda S/5 Central and Arrhythmia Workstation User’s Reference Manuals

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Class I and internally powered 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 is 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 - degree of protection against harmful ingress of water.

In accordance with EU Medical Device Directive: IIb

Responsibility of the manufacturer Datex-Ohmeda Division, Instrumentarium Corp. is responsible for the safety, reliability and performance of the equipment only if: assembly, extensions, readjustments, modifications, service and repairs are carried out by personnel authorized by Datex-Ohmeda. electrical installation complies with appropriate requirements. the equipment is used in accordance with this User’s Guide.

Intended purpose (Indications for use) The Datex-Ohmeda AS/3 Compact Anesthesia Monitor with L-ANE02 or L-ANE02A software is intended for multiparameter patient monitoring with optional patient care documentation.

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Contents Safety (Safety/Symbols)... 3 Symbols (Safety/Symbols)... 4 System introduction (Intro) ... 5 Monitoring basics (Basics) ... 7 Setting up the monitor before use (Setup) ... 9 Alarm basics (Alarms) ... 13

Cleaning and care (Care) ... 14 Performance (Specs.)... 17 Abbreviations (Abbr.)... 23 Supplies and accessories (Supplies)... 29 Trademarks Datex®, Ohmeda®, and other trademarks AS/3, CS/3, S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, 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. © Instrumentarium Corp. All rights reserved.

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Safety These precautions refer to the entire system. Warnings and cautions specific to parts of the system can be found in the relevant section.

Warnings

Cautions

A WARNING INDICATES A SITUATION IN WHICH THE USER OR THE PATIENT MAY BE IN DANGER OF INJURY OR DEATH.

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 measurements. Single-use accessories are not designed to be reused. • Before connecting the power cord tothe 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. • Refresh the batteries completely once a month (see Section “Cleaning and care”). • 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.

• 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. • To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics. The monitor measures only nonflammable anesthetics. • Do not use the monitor in high electromagnetic fields (for example, during MRI). • Keepthe 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. • Do not touch battery operated monitor during defibrillation procedure. • If the integrity of the external protective earth conductor arrangement is in doubt, use the monitor with battery operation. • Do not connect any external devices to the system other than those specified by Datex-Ohmeda. • If the unit fails to respond as described, do not use the monitor until tested and repaired by authorized service personnel.

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

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Symbols Attention, consult accompanying documents. When displayed next to the O2 value, indicates that the FiO2 low alarm limit is set below 21 %. When displayed next to the HR value, indicates that the pacer is set on R or a wide QRS is selected.

In the message field, indicates that the alarms are silenced. In the digit field or in a menu, indicates that the alarm source is selected off. Equipotentiality. Monitor can be connected to potential equalization conductor.

BIS: On the Aspect DSC indicates that the converter must not be opened for any reason, or autoclaved.

Alternating current

On the rear panel this symbol indicates the following warnings and cautions: − Electric shock hazard. Do not open the cover or the back. Refer servicing to qualified personnel. − For continued protection against fire hazard, replace only with same type and rating of fuse. − Disconnect from the power supply before servicing. − Do not touch battery operated monitor during defibrillation procedure. − Lithium battery on CPU board: follow the local regulations for disposal.

Fuse. Replace only with a fuse with the same type and ratings. - +

Battery operation and remaining capacity - +

Charge

Battery charging

SN, S/N

Serial number Submenu. Selecting a menu item with this symbol opens a new menu. The monitor is connected to the Datex-Ohmeda Network.

Type BF (IEC 60601-1) protection against electric shock

Data card (green) and/or the Menu card (white) is inserted.

Type BF (IEC 60601-1) defibrillator-proof protection against electric shock

Indicates the beats detected. Respiration rate is measured using impedance respiration measurement.

Type CF (IEC 60601-1) protection against electric shock Type CF (IEC 60601-1) defibrillator-proof protection against electric shock

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System introduction (1) AS/3 Compact Anesthesia Monitor with modules inside (2) Remote Controller, K-REMCO (3) Printer (4) Datex-Ohmeda Network

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NOTE: Connect only one patient to one AS/3 Compact Anesthesia Monitor at a time.

WARNING: Before starting to use the system, ensure that the entire 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. WARNING: A printer must be supplied from an additional transformer providing at least basic isolation (isolating or separating transformer).

NOTE: After transferring or reinstalling the monitor, always check that it is properly connected and securely attached. NOTE: The monitor display is fragile; handle it with care and ensure that it is not exposed to mechanical shocks or constant direct sunlight.

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

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System possibilities

AS/3 Compact Anesthesia Monitor connections

The Datex-Ohmeda AS/3 Compact Anesthesia Monitor provides places for up to four single-width or two double-width modules. You can use the same modules and patient accessories in the Compact Anesthesia Monitor, Compact Critical Care Monitor, Anesthesia Monitor, and Critical Care Monitor. 1

Optional components for the AS/3 Compact Anesthesia Monitor are: • built-in recorder in the F-CMREC frame or the recorder module, M-REC • network functionality with B-UPINET board or B-CMNET board • DataCard and MemCard functionality with memory board, B-CMMEM, or the memory module, M-MEM

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(1) (2) (3) (4) (5) (6) (7) (8) (9)

Communication between monitors

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You can use the AS/3 Compact Anesthesia 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.

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Air filter Recorder (optional) Connector for Anesthesia Keyboard and Remote Controller Potential equalization Receptacle for power cord Place for network connector B-NET Device plate Place for network connector B-UPINET or B-UPI Insertion slots for memory cards (optional)

To view other patient monitors, the monitor needs to be connected to the Datex-Ohmeda Network. To gather, store, and transfer data between different Datex-Ohmeda monitors, use memory cards.

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Monitoring basics You can control monitoring through the keys on the monitor’s keyboard, modules, Anesthesia Record Keeping Keyboard and Remote Controller. The commands introduced in this User’s Guide focus on the monitor’s keyboard hard keys.

Command Board - functions of some hard keys Silence active alarms or pre-silence all alarms

Freeze waveforms Take up to 400 for 60 sec. snapshots

Enter measurement menus

Review alarm limits

Silence Alarms

Freeze

Take Snapshot

Alarms Setup

Record/ Print

ECG

NIBP

Invasive Pressures

Help

Reset Case

Trends

Monitor Setup

Patient Data

Pulse Oximetry

Airway Gas

Others

Return settings to their defaults

Review trends and snapshots

Select mode, adjust display, select split screen option

Close menus, return to basic screen

Normal Screen

Add patient demographics, enter laboratory data, choose other site alarms or views

Side panel keys

Remote Controller

There are keys on the monitor’s side panel for ON/Standby, NIBP, Invasive Pressures and Recorder functions. With these keys, you can start or end a function immediately.

The Remote Controller allows access to the same menus as the Command Board. It also has some direct function keys that start or end a function immediately. To enter functions that do not have their own key, press the Menu key.

NOTE: Recorder functions are available with the optional internal recorder or recorder module only.

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ComWheel Enter C.O., SvO 2, NMT, Temp, Resp, EEG, Tonometry, BIS menus and calculations

Enter other menus

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Navigating in menus

Parameter/module selection

A menu is a list of functions or commands. To display a menu, press one of the hard keys. Adjustments in the menus are made with the ComWheel. For example, to make adjustments to the ECG display: 1. Press the key to open the function menu. 2. Turn the ComWheel to select the desired function in the menu. 3. Press the ComWheel to open a submenu or an adjustment window. 4. Press the ComWheel to confirm the selection.

Some modules are identical and cannot be used in the same system. See the table below when choosing modules for different parameters. To monitor:

Select only one of these identical modules

ECG (E), NIBP (N), 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-STD95 and S-STD96 software.

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

Common parts for modules 1

(1) Insertion guide slot (2) Module keys (3) Patient cable connectors (4) Module release latch

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

M-COP or M-COPSv

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

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

Separate SpO2 measurement

M-NSAT or M-OSAT

The following parameters have no identical modules:

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Inserting a module 1. Align the module with the insertion guide. 2. Push the module into the Compact Monitor frame until it clicks.

Removing a module 1. Press the release latch. 2. Pull out the module. You can connect and disconnect modules during monitoring. 8

NMT

M-NMT

EEG and AEP

M-EEG

Tonometry (PgCO2)

M-TONO

BIS

M-BIS

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Setting up the monitor before use Before starting to use the monitor, check the monitor installation settings and what is configured in different user modes, and make the necessary changes. The user modes are hospital-specific. The default modes are CPB Mode, General, Invasive, Regional, Neuro, Pediatric, and Recovery. For more information about the default user modes, see the Default Configuration Worksheet delivered with the monitor. For more information about the installation settings and user modes, see the User's Reference Manual.

Passwords

Setting time and date

The password for entering the Install/Service menu is 16 4 34. For the password for saving the changes permanently in the user mode, see User's Reference Manual.

NOTE: If the monitor is connected to the S/5 Central, it follows the Central’s time settings and the Time and Date menu is not available.

NOTE: You cannot change the monitor’s time settings after the case has been started. This prevents loss of trend data.

Interfacing 1. Press the Monitor Setup key and select Interfacing. 2. Select desired interfaced internal modules or external monitors.

1. Press the Monitor Setup key and select Time and Date. 2. Turn and press the ComWheel to set the time and date.

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Changing the monitor installation settings The monitor installation settings are the same in all user modes. The changes are preserved until changed again. Press the Monitor Setup key and select Install/Service, enter the password and select Installation:

Printer

Monitor Settings

ECG Printout Type: Select 25mm, 50mm or USA. Snapshot Printout: Select 12.5 mm/s or 25 mm/s. Printer Connection: Select printer connection (default: None). Paper Size: Select A4 or Letter. Recorder Connection: Select recorder connection (default: None)

Monitor Type: Monitor type defines the text on the start screen. ARRWS Network: Select YES if ARRWS is in the network. ARK Settings: Set Record Keeping ON/OFF and change settings. Parameter Settings: Set tidal volume calculation conditions, CO2 humidity compensation and inspired flow drawing direction.

Alarm Options

Units

Show limits: Select YES to show alarm limits in digit fields. Audio OFF: Select NO to disable alarm silencing. This hides the silencing options in the Audio ON/OFF menu in Alarms Setup. Latching Alarms: Select YES to keep alarm messages on screen until Silence Alarms key is pressed. Reminder Volume: Adjust volume of audible reminder tone. Alarm Tones: Select alarm tones.

Change units for height, weight, parameters, energy expenditure, laboratory values and calculations. To change the temperature and CO2 units, go to Temperature Setup menu or CO2 Setup menu. The changes are permanent.

Display Setup

Analog Output Signals

Change the number of colors on the display (the result depends on the LCD display type.)

Select the type of incoming data for different channels. This is used, for example, when collecting data for research purposes.

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Changing the user modes NOTE: If you want to make some changes in user modes, we recommend you contact the person responsible for the configuration. When new settings are saved, they should be marked in the "Default Configuration Worksheet." The instructions below describe how to change the modes permanently. 1. Select the user mode you wish to change by pressing Monitor Setup and selecting Select Mode. 2. To make changes in: − sweep speed, parameter colors, screen setup, Normal Screen layout, pages layout, trends, snapshots, press Monitor Setup and select Install/Service (if necessary). For instructions, see below. − parameter setup, press a parameter key and go to the setup menu. For instructions, see parameter sections in User's Guide Part II. − alarm limits and volume, press Alarms Setup. For instructions, see section "Alarms" in User's Guide Part II. 3. Confirm changes through Monitor Setup - Install/Service - Save Modes. Select the current mode from the list and select Save. You can save the change also in other modes. If you do not save the changes in the modes, the changes are only temporary and valid until you eset the case or change the mode, or until more than 15 minutes has elapsed from the turn-off of the monitor.

Changing the startup mode

Changing the parameter colors

1. Select Monitor Setup - Install/Service - Save Modes. 2. Select Startup Mode - 1, 2, 3, 4, 5 or 6.

To change the colors for parameter waveforms, digits and trends, select Monitor Setup - Install/Service -Colors.

Renaming a mode 1. Select Monitor Setup- Install/Service - Save Modes.

Changing the recorder settings 1. Press Record/Print. 2. Select Record Waveforms and select the recorded waveforms,

2. Select the mode, select Name and give a new name.

delay, paper speed and length, and select if you wish to record waveforms on alarms. 3. Select Record Trends and set the numerical trend resolution and trend type, default trend type, and select the graphical trend recorded in upper and lower field.

Loading modes 1. Select Monitor Setup - Install/Service - Save Modes. 2. Select Load Modes and load from/to card or from/to network.

Changing the printer settings Select Record/Print - Print Graphical and select the pages to print

Changing the waveform sweep speeds 1. Select Monitor Setup - Sweep Speeds.

and how many hours to print on one page.

2. Select the parameters and adjust the values.

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Changing the Normal Screen layout Press Monitor Setup and select Install/Service – Screen 1 Setup.

Configuring trend pages To select the parameters that are displayed on the graphical trend pages (max. 6): 1. Press Monitor Setup and select Install/Service - Trends & Snapshots - Graphical Trends. 2. Select the graphical trend page you want to change. 3. Select parameters for fields.

• Waveform Fields: Select the displayed waveforms. • Digit Fields: Change the contents of or turn off the field. • Split Screen: Select what you wish to display with the waveforms (minitrends, spirometry, EEG, EP, ST or None). • Minitrend Length: Select the length of the minitrend.

Setting trend length and time scale Press Trends.

Changing the layout of other pages You can check the contents of the pages by pressing ComWheel in Normal Screen. To change the layout of the pages: 1. Press Monitor Setup and select Install/Service -Pages Setup. 2. Select the page and make the changes.

• Select Time Scale and the value. • Select Trend Scales and adjust the scales.

Configuring snapshots To change the snapshot setting, press Monitor Setup and select Install/Service - Trends & Snapshots - Snapshot: • Field x: Select to display waveform, graphical trend or numerical trend. • Create on Alarms: Select Yes (default) to create automatic snapshots for Tachy, Brady, Art high, Art low alarms. You can select other arrhythmia alarms to create snapshots through the Arrhythmia Alarms menu. • Automatic Print: Select All to print all the snapshots immediately after creation, Alarms to print snapshots created on alarms or No to print only on request. • Print Loops: Select Yes to print Patient Spirometry loops when snapshots are taken.

Changing the display brightness 1. Press Monitor Setup and select Display Brightness. 2. Select from 30 – 100%.

Setting the default trend You can select graphical or numerical trends to be displayed by default. 1. Press Monitor Setup and select Install/Service - Trends & Snapshot. 2. Select Default Trends and Graph or Num.

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Alarm basics Enabling the alarms

Alarm indications

To enable the alarms, connect the patient cables. If the source is selected, the alarms are operative also when the measurement is not displayed (except the respiration measurement alarms).

When an alarm becomes active, messages appear in order of priority. The alarming measurement value flashes and its background color indicates the alarm category (see the table below). In some cases, there may be a message on the display giving more detailed information. An audible alarm is also triggered.

Alarm categories The priority depends primarily on the cause and alarm duration. Visual Red

Meaning

Tone pattern (selected when the system is configured)

Front panel LED

For life threatening situations

Triple + double beep every 5 seconds or continuous beep --- -- 5 --- --/ -----

red LED lit

Yellow

For serious but not life threatening problems

Triple beep every 19 seconds or double beep every 5 seconds --- 19 --- / -- 5 -- 5 --

yellow LED blinking

White

Advisory

Single beep -

yellow LED lit

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Cleaning and care Daily and between patients

Once a month

Every six months

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Perform gas calibration for gas exchange monitoring, see below.

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Refresh the batteries, see below.

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Check the fan filter on the monitor’s side panel, on the gas module’s front panel and under the display. Clean if necessary: 1. Pull the filter out and wash it in detergent solution. 2. Allow to dry before reinserting. Do not use pressurized air. Replace the filter if it is damaged. Change the D-fend water trap every two months and when ‘Replace D-fend’ appears.

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Wipe the monitor surface. Wipe the ECG trunk cable, NIBP cuff and cables, and SpO2 sensors. Change or sterilize all airway and invasive patient accessories. Change the Tonometrics catheter between patients. Empty the D-fend water trap, see below. Change the BIS sensor between patients. Check that the accessories, cables and monitor parts are clean and intact.

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Perform gas calibration for tonometry and airway gas monitoring, see next page.

Permitted detergents

Permitted disinfectants

DO NOT !

− Datex-Ohmeda Cleaning Fluid − Other mild detergents

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Do not use hypochlorite, acetone-, phenol- or ammonia based cleaners.

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Do not autoclave the device or its parts.

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Do not immerse any part of the device in liquids, or allow liquid to enter the interior.

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Do not apply pressurized air to any outlet, or tubing connected to the monitor.

Ethanol Isopropyl alcohol Chlorite compounds Glutaraldehyde

More comprehensive checking See the “Technical Reference Manual.”

Before cleaning 1. Turn off the power. 2. Disconnect the power cord.

WARNING: After cleaning or if liquid has accidentally entered the monitor, ensure that every part of the monitor is dry before reconnecting it to the power supply.

After cleaning 1. Let dry completely. 2. Reconnect the power cord and turn on the monitor power. 14

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D-fend water trap

Refreshing the batteries

• Empty the container whenever half full. • Change the D-fend water trap every two months and when the text ‘Replace D-fend’ appears. • Do not wash or reuse the water trap cartridge. • Change the green D-fend+ water trap every 24 hours.

1. Turn on the monitor. 2. Connect the monitor power cord to power outlet for at least 5 hours. 3. Remove the power cord and wait until the monitor turns off. Then wait for another 15 minutes. 4. Reconnect the power cord to power supply and charge the battery for at least 5 hours.

Reusable D-lite sensor

Changing fuses

The reusable D-lite sensor can be washed in a washing machine and steam autoclaved. Make sure that the sensor is dry and connectors not damaged. A tight connection is essential for correct measurement.

1. Remove the power cord. 2. Remove the fuse holder by pushing the locking pin and pulling the holder gently out. 3. If a fuse is blown, ensure that you replace it with a fuse of the correct type and rating.

Other accessories For information on how to clean and check reusable accessories, see the accessory package. Do not reuse disposable accessories.

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Calibrating Patient Spirometry

Calibration

Perform flow calibration once a year or when the difference between the inspiratory and expiratory volumes is permanent. See the “Technical Reference Manual“ for more information.

1. Turn on the power. Let the monitor warm up for 30 minutes. 2. Attach a regulator to the calibration gas container.

Calibrating gas exchange

NOTE: See “Supplies and accessories” for correct regulator and gas. NOTE: % is used for CO2 regardless of selected units. NOTE: Ensure that the calibration gas and regulator are functioning properly before calibration. Perform annual maintenance on the regulator as required.

To ensure gas exchange accuracy, perform the airway gas calibration once a month and patient spirometry calibration once a year. Use 2-m (6.5-ft) airway gas sampling line.

Tonometry Calibrating airway gases

1. Connect the calibration gas sampling line to the D-gate regulator and to the module’s catheter connector. 2. Press the Others key and select Tonometry - PgCO2 Calibration. 3. Wait until the text ‘Feed gas’ appears. Open the regulator and start feeding gas until the text ‘Adjust’ appears. Close the regulator. 4. Check that the displayed values match the values on the calibration gas container. Adjust with the ComWheel if necessary and confirm. 5. If airway gases are measured, calibrate the gas module at the same time.

Follow recommended calibration intervals for airway gases (every six months in normal use and every two months in continuous use) to ensure that the measurement accuracy remains within specifications. 1. Attach a new sampling line to the water trap. Connect the other end of the sampling line to the regulator on the gas container. 2. Press the Airway Gas key. 3. Select Gas Calibration. 4. Wait until the texts ‘Zero OK’ and then ‘Feed Gas’ appear, open the regulator and start feeding gas. Press the ComWheel and continue feeding gas until the text ‘Adjust’ appears on the screen. 5. Check that the displayed gas values match the values on the calibration gas container. Adjust with the ComWheel, if necessary.

NOTE: Use only Datex-Ohmeda Calibration gas sampling line; wrong line length or diameter can cause incorrect calibration. NOTE: Do not wash or disinfect calibration gas sampling lines.

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Performance Datex-Ohmeda Compact Anesthesia Monitor Power supply

Rated voltages and frequencies: Allowed voltage fluctuations: Max. power consumption: Battery operation Batteries: Charging time: Operation time:

100-240 V 50/60 Hz ±10 % 140 VA NiCd 5 hours up to 1hour

Environmental conditions

Operating temperature: +10 to +35°C (50 to 95°F) Storage and transport temperature: -10 to +50°C (14 to 122°F) Relative humidity: 10 to 90 % noncondensing, in airway 0 to 100 % condensing Atmospheric pressure: 660 to 1060 mbar (500 to 800 mmHg)

Hemodynamic Modules M-NE(12)STPR, M-NE(12)TPR, M-NE(12)STR, M-ESTPR, M-ETPR, M-ESTR; M-P, M-PP, M-PT; M-NIBP Letters in the module name stand for: N= NIBP, E= ECG, 12 = up to 12 ECG leads, S= Pulse oximetry, T= Temperature, P= Invasive blood pressure, R= Impedance respiration

ECG Filter modes: monitoring filter 0.5 to 30 Hz ST filter 0.05 to 30Hz diagnostic filter 0.05 to 100 Hz - 12-lead ECG: 0.05 to 150 Hz With 60 Hz power supply frequency: monitoring filter 0.5 to 40 Hz ST filter 0.05 to 40 Hz Defibrillation protection 5000 V, 360 J Recovery time 2 seconds Heart rate Measurement range: 30 to 250 bpm Measurement accuracy: ±5 % or ±5 bpm Pacemaker pulse detection: detection level: 2 to 500 mV pulse duration: 0.5 to 2 ms Respiration Respiration range: 4 to 120 resp/min Accuracy: ± 5% or ± 5 resp/min NOTE: Respiration measurement is intended for patients over three years old. Pulse oximetry Proportional scaling of plethysmographic waveform SpO2 Measurement and display range: 40 to 100 % Calibration range 50 to 100 % Calibrated against functional oxygen saturation

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Measurement accuracy (% SpO2 ±1SD): 100 to 80 %, ±2 digits; 80 to 50 %, ±3 digits; 50 to 40 %, unspecified Display update time: 5 seconds Display averaging time: adjustable: 10 seconds, 20 seconds or beat-to-beat Display resolution: 1 digit (1% of SpO2) Pulse rate Measurement and display range: 30 to 250 bpm Measurement accuracy: ±5 % or ±5 bpm Default 2) SpO2 high Off, low 90%, alarm limits PR high 160, low 40 1) Accuracy is based on deep hypoxia studies using Datex-Ohmeda Finger Sat Sensors on volunteered subjects. Arterial blood samples have been analyzed by a Radiometer OSM Co-oximeter. 1 SD (standard deviation) = 68 % of all readings in the specified range in stable conditions. 2) Limits are adjustable: OFF – 51% for SpO2 high 50 – 100% for SpO2 low 250 – 35 bpm for PR high 30 - 245 bpm for PR low

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Invasive blood pressure Measurement range: -40 to 320 mmHg Measurement accuracy: ±5 % or ±2 mmHg Pulse rate Measurement range: 30 to 250 bpm Accuracy: ±5 % or ±5bpm Transducer sensitivity: 5 µV/V/mmHg Temperature Measurement range: 10 to 45°C (50 to 113°F) Measurement accuracy: ±0.1 °C (25 to 45.0°C) ±0.2°C (10 to 24.9°C) Probe type: Compatible with YSI 400 series NIBP Measurement range: adult 25 to 260 mmHg child 25 to 195 mmHg infant 15 to 145 mmHg Pulse rate range accepted: 30 to 250 bpm Typical measuring time: adult 23 s , infant 20 s NOTE: NIBP measurement is intended for patients weighing over 5 kg (11 lb.)

Cardiac Output Modules, M-COP and M-COPSv

Compact Airway Modules, M-C, M-CO, M-COV, M-CAiO, M-CAiOV, M-CAiOVX

Pressure performance as previous. Cardiac output Measurement range: 0.1 to 20 l/min Repeatability: ±2 % or 0.02 l/min Catheters: Edwards Lifesciences Corp. compatible SvO2 Measurement range: 1 to 98% Measurement accuracy: ±2% SvO2 equals 1 standard deviation for range of 30% to 95% SvO2 and 6.7 to 16.7 g/dl Hb when using in vivo calibration. Catheters: Edwards Lifesciences Corp. SvO2 catheter REF Measurement range: 1 to 85% Repeatability: ±2% as measured by electronically generated pulsatile curves for range 10 to 60%. Catheters: Edwards Lifesciences Corp. REF catheter

Letters in the name stand for: C = CO2 and N2O, O = Patient O2, V = Patient Spirometry, A = Anesthetic agents, i = Agent identification, X = Gas exchange 3): 200 ml/min Sampling rate 3): Sampling delay : < 2.5 s typical with a 3 m sampling line *) Total system response time: 2.9 seconds typical with a 3 m sampling line, including sampling delay and rise time Warm-up time: 2-5 min, 30 min for full spec. 4): Default alarm limits EtCO2 high 8%, low 3% FiEnf high 5.1%, low Off FiCO2 high 3%, low Off EtEnf high 3.4 %, low Off EtO2 high Off, low 10% FiIso high 3.4%, low Off FiO2 high Off, low 18% EtIso high 2.3 %, low Off FiN2O high 82% FiDes high 18%, low Off FiHal high 2.2%, low Off EtDes high 12 %, low Off EtHal high 1.5 %, low Off FiSev high 5.1%, low Off EtSev high 3.4 %, low Off 3): Typical value 4): Alarm limits and their adjustment range may vary according to the mode used.

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