S5 Compact Anesthesia Monitor Users Guide Part 1 Monitor Setup and Reference Nov 2004

Datex-Ohmeda S/5 Compact Anesthesia Monitor User’s Guide Part I: For Monitor Setup and Reference Related to software licenses L-CANE03 and L-CANE03A 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. 8005660-1 November 2004 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 S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. The S/5 Compact Anesthesia Monitor with L-CANE03 and L-CANE03A 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. The S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is also indicated for documenting patient care related information. The S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A 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 S/5 Compact Anesthesia Monitor. Descriptions refer to S/5 software licenses L-CANE03 and L-CANE03A. If you are a new user of the monitor, we suggest you begin with sections "Safety precautions,” “System introduction" and "Monitoring basics”. Also read Part II of this User's Guide. The following conventions are used: − N Names of the hard keys on the Command Bar, Remote Controller and modules are written in the following way: ECG.

− − − − −

Menu items are written in bold italic typeface: ECG Setup. Menu access is described from top to bottom. For example, the selection of the Screen 1 Setup menu item and the Waveform Fields menu item would be shown as Screen 1 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.” In this manual, the word “select” means choosing and confirming.

Classifications In accordance with IEC 60601-1: − − −

Related documentation

−

Clinical aspects, basic methods of measurement and technical background: S/5 Compact Anesthesia Monitor, User’s Reference Manual Instructions for daily use: S/5 Compact Anesthesia Monitor, User's Guide Part II Installation, technical solutions and servicing: S/5 Compact Anesthesia Monitor and S/5 Compact Critical Care Monitor, S/5 Modules, Technical Reference Manuals Datex-Ohmeda S/5 Network, Wireless LAN Installation Guide Options and selections of the software: Default Configuration Worksheet Other devices closely related to the S/5 Compact Anesthesia Monitor: S/5 Central and S/5 Arrhythmia Workstation User’s Reference Manuals

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 In accordance with CISPR 11: Class B 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 S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is intended for multiparameter patient monitoring with optional patient care documentation.

1

2

Contents Interfacing external devices ...19 Performance ...21 Abbreviations ...29 Supplies and accessories ...35 End User License Agreement ...41 Warranty ...42

Safety precautions ... 3 Symbols... 5 System introduction ... 7 Monitoring basics... 9 Setting up the monitor before use... 11 Cleaning and care ... 15 Alarm basics ... 18

Trademarks Datex®, Ohmeda®, and other trademarks S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini D-fend, TruTrak®+, OxyTip+, MemCard, ComWheel, EarSat, FingerSat, FlexSat, PatientO2, Entropy, 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. A portion of the entropy software is derived from the RSA Data Security, Inc. MD5 Message-Digest Algorithm.

2

3

Safety precautions These precautions refer to the entire system. Warnings and cautions specific to parts of the system can be found in the relevant section. • Use only accessories and defibrillator-proof cables and invasive pressure transducers approved by Datex-Ohmeda. Other cables, transducers and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement. Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement. • Single-use accessories are not designed to be re-used. Re-use may cause a risk of contamination and affect the measurement accuracy. • The monitor or its components should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor and its components should be observed to verify normal operation in the configuration in which it will be used. • Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. See "Safety precautions: ESD precautionary procedures" in the "User's Reference Manual" for details. • If liquid has accidentally entered the equipment, disconnect the power cord from the power supply and have the equipment serviced by authorized service personnel. • The system may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. • If the unit fails to respond as described, do not use the monitor until tested and repaired by authorized service personnel.

Warnings

A WARNING indicates a situation in which the user or the patient may be in danger of injury or death. • 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 the presence of flammable anesthetics. The monitor measures only nonflammable anesthetics. • Do not use parameters requiring electrical connection to patient during MRI. • Do not connect any external devices to the system other than those specified by Datex-Ohmeda. • 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. • Do not touch the patient, table, instruments or the monitor during defibrillation. • If the integrity of the external protective earth conductor arrangement is in doubt, use the monitor with battery operation.

3

4

Cautions

Disposal

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

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

• 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. • Refresh the batteries completely once a month (see “Cleaning and care”). • Do not store or use the monitor outside the temperature and humidity ranges specified in the "Performance" section of this manual. • Do not subject memory cards to excessive heat, bending or magnetic fields. • 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. • Ensure that the module is properly orientated (i.e. the module release latch is facing downward) before insertion.

Points to note • Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the "Technical Reference Manual" by qualified Datex-Ohmeda trained personnel • Portable and mobile RF communications equipment can affect the medical electrical equipment. • The allowed Datex-Ohmeda cables, transducers and accessories for the system are listed in the "Supplies and accessories" section of this manual. • The equipment is suitable for use in the presence of electrosurgery. Please notice the possible limitations in the parameter sections and in the "Performance" section. • Service and reparations are allowed for authorized service personnel only.

4

5

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

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. − BIS: On the Aspect DSC indicates that the converter must not be opened for any reason, or autoclaved. − On the interface module, M-INT, indicates that it is for connecting external devices. Do not connect patient cables to the module. − On the M-TONO module indicates that the module should be used only with Tonometrics catheters. − 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 the fuse only with one of the same type and rating. - Disconnect from the power supply before servicing. - Do not touch battery operated monitor during defibrillation. - Lithium battery on CPU board: follow the local regulations for disposal.

When displayed in the upper left corner of the screen, indicates that the alarms are silenced. When displayed in the menu or digit fields, indicates that the alarm source has been turned off or alarm does not meet the alarm-specific activation criteria. Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current Fuse. Replace the fuse only with one of the same type and rating.

Battery operation and remaining capacity (green bar).

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

Battery charging (white bar).

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

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

5

6

Submenu. Selecting a menu item with this symbol opens a new menu.

WLAN signal strength

The monitor is connected to the Datex-Ohmeda S/5 Network (Local Area Network).

ESD warning symbol for electrostatic sensitive devices. Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. See "Safety precautions: ESD precautionary procedures" in the "User's Reference Manual" for details.

The monitor is connected to the Datex-Ohmeda S/5 Network (Wireless Local Area Network). Data Card (green) and/or Menu Card (white) is inserted. A blinking heart next to the heart rate or pulse rate value indicates the beats detected.

Symbol for non-ionizing electromagnetic radiation. Interference may occur in the vicinity of equipment marked with this symbol. SN, S/N

A lung next to the respiration rate value indicates that respiration rate is calculated from the impedance respiration measurement.

Serial number

6

7

System introduction (1) Compact Anesthesia Monitor with modules inside (2) Remote Controller, K-CREMCO (3) Printer (4) Datex-Ohmeda S/5 Wireless Network (WLAN) Access Point, N-WAP (5) Datex-Ohmeda S/5 Network (LAN) NOTE: Your system may not include all these components. NOTE: Connect only one patient to the Compact Anesthesia Monitor at a time. NOTE: After transferring or reinstalling the monitor, always check that it is properly connected and securely attached. NOTE: The monitor display is fragile. Ensure that it is not placed near a heat source or exposed to mechanical shocks, pressure, moisture, or direct sunlight.

1

5

3

2

4

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

Interfacing other devices External devices can be connected to the Compact Anesthesia Monitor, and the data they measure can be seen on the monitor screen. For more information, see section "Interfacing external devices" and the "User's Reference Manual."

7

8

Compact Monitor connection 1

9

11

10

(1) (2) (3) (4) (5) (6)

12

2 3 4 5 6

14 8 13 7

Air filter NET connector NET ID connector (not used with N-CMW) Built-in recorder (optional) SYNC connector Connector for anesthesia record keeping keyboard or K-CREMCO (7) Potential equalization (8) Serial port (9) Receptacle for power cord (10) WLAN PC card led (11) WLAN PC card (12) Slot for Memory Cards (PCMCIA) and WLAN PC card (13) Connector for S/5 Device Interfacing Solution (14) Modules

System possibilities

Communication between monitors

The Compact Anesthesia Monitor provides places for up to four singlewidth 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. The Network option, N-CMNET, is always included. Optional components for the Compact Anesthesia Monitor are: • Built-in recorder, N-CMREC1 • Wireless network option, N-CMW Possible software options for the Compact Anesthesia Monitor are: • MemCard option, N-CMMEM NOTE: Insert the WLAN PC card in the first slot from the front. NOTE: Memory Module, M-MEM, is not compatible with the S/5 Compact Anesthesia Monitor.

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. To gather, store, and transfer data between different Datex-Ohmeda monitors, use memory cards or connect the monitor to S/5 Network. The green Data Card is for storage and transfer of patient data. The white Menu Card is used for storing the anesthesia record keeping menus and configurations, and for loading patient data and user modes from the Data Card. With WLAN option, it is recommended to use the Data Card.

8

9

Monitoring basics You can control monitoring through the keys on the monitor’s Command Board and side panel, modules, anesthesia record keeping keyboard and Remote Controller. The commands introduced in this User’s Guide mainly focus on the Command Board hard keys and module keys.

Command Board - functions of some hard keys Silence active alarms or Freeze pre-silence waveforms all alarms for 60 sec.

Review alarm limits Take up to 400 snapshots

Start recording and printing

Enter measurement menus

Close menus, return to basic screen

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 for a new patient

Review trends and snapshots

Select mode, select waveforms and digits, select split screen option

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.

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

Normal Screen

ComWheel Enter menus for C.O., SvO2, NMT, Resp&Temp, EEG&EP, BIS, Entropy, Tonometry and calculations

Navigating in menus Enter other menus

9

A menu is a list of functions or commands. To display a menu, press one of the hard keys. Selections in the menus are made with the ComWheel. For example, to change the ECG display: • Press the ECG key to open the function menu. • Turn the ComWheel to select the desired function in the menu. • Push the ComWheel to open a submenu or an adjustment window. • Push the ComWheel to confirm the selection.

10

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

1

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-ARK94, SSTD95, S-ARK95, S-STD96 and S-ARK96 software. M-NIBP, M-NE(12)STPR, M-NE(12)TPR, M-NE(12)STR M-P, M-PP or M-PT M-COP or M-COPSv M-CO, M-COV, M-CAiOV, M-CAiO, M-CAiOVX, M-miniC

2

NIBP (N) Pressure (P) C.O. (CO), Pressure (P) or SvO2 (Sv) CO2 (C), O2 (O), Spirometry (V), anesthetic agents(A), agent identification (i), gas exchange (X) Separate SpO2 measurement

3

4

M-NSAT or M-OSAT NOTE: M-NSAT and M-OSAT can be used with M-NE(12)STPR, M-NE(12)STR, M-ESTPR, M-ESTR, M-ESTP and M-EST. The SpO2 measurement in M-NSAT and M-OSAT automatically overrides the SpO2 measurement in these modules. The following parameters have no identical modules: NMT M-NMT EEG and AEP M-EEG Tonometry (PgCO2) M-TONO BIS M-BIS Entropy M-ENTROPY

Inserting a module 1. Ensure that the module is properly orientated (i.e. the module release latch is facing downward). 2. Align the module insertion guide slot with the frame insertion guide. 3. Push the module into the unit until it clicks.

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

Parameter/module selection Some modules are identical and cannot be used in the same system. See the following table when choosing modules for different parameters.

10

11

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. If you wish to make permanent changes, we recommend that you contact the person responsible for the configuration of the system. For more information about the default user modes, see the "Default Configuration Worksheets" 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 default password for entering the Install/Service menu is 16 4 34. The default password for entering the Save Modes menu is 13 20 31.

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.

Interfacing 1. Press Monitor Setup and select Interfacing.

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

2. Select the desired internal modules or interface external monitors.

11

12

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

Printer

Monitor settings

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

Monitor Type: Monitor type defines the text on the start screen. ARRWS Network: Select YES if Arrhythmia Workstation 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 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 alarm reminder tone. Alarm Tones: Select alarm tones.

Units • Change units for height, weight, parameters, energy expenditure, laboratory values and calculations. • You can change temperature units in the Temp Setup menu (Others - Resp & Temp Setup - Temp Setup) and CO2 units in the CO2 Setup menu (Airway Gas - CO2 Setup). The changes are permanent.

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

12

13

Changing the user modes NOTE: If you want to make 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 Worksheets." See below for instructions on 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. If necessary, select Install/Service. 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 - Save. You can save the changes also in other modes. If you do not save the changes in the modes, they are temporary and valid only until you reset the case or change the mode or until more than 15 minutes has elapsed from the turn-off of the monitor. Entering Save Modes requires a password, see "Passwords" above.

Changing the start-up mode 1. Select Monitor Setup - Install/Service - Save Modes.

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

2. Select Startup Mode - 1, 2, 3, 4, 5 or 6.

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

Renaming a mode 1. Select Monitor Setup - Install/Service - Save Modes. 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. NOTE: To load modes from the Data Card, you need the Menu Card in the other slot.

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. Slow waveforms show the amplitude changes better.

13

14

Changing the Normal Screen layout Press Monitor Setup and select Screen 1 Setup:

Configuring trend pages To select the parameters that are displayed on the graphical trend pages: 1. Press Monitor Setup and select Install/Service - Trends & Snapshot - 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 a field or turn it off. • 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.

Changing the layout of other pages

Setting trend length and time scale Press Trends.

You can check the contents of the pages by pushing 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

Changing the display brightness 1. Press Monitor Setup and select Display brightness.

To change the snapshot settings, press Monitor Setup and select Install/Service - Trends & Snapshot - Snapshot: • Field 1: Select to display waveform, graphical trend or numerical trend. • Create on Alarms: Select YES (default) to create automatic snapshots for Tachy, Brady, Art high and Art low alarms. You can select other arrhythmia alarms to create snapshots through the Arrhythmia 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.

2. Select from 30 to 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 Trend and Graph or Num.

14

15

Cleaning and care Daily and between patients

Once a month

Every six months

• •

•

•

• • • • • • •

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. Clean, disinfect or sterilize reusable temperature probes. Change the Tonometrics catheter between patients. Empty the D-fend water trap. Change the BIS sensor between patients. Change the entropy sensor between patients. Check that the accessories, cables and monitor parts are clean and intact.

Permitted detergents − Datex-Ohmeda Cleaning Fluid − Other mild detergents

• •

•

Perform gas calibration for gas exchange monitoring, see below. Refresh the batteries, see below. Check the fan filter on the monitor’s side panel, on the gas module’s front panel and under the display unit. Clean if necessary: 1. Pull out the filter. 2. Wash it in detergent solution and 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.

Permitted disinfectants − Ethanol − Isopropyl alcohol − Chlorite compounds − Glutaraldehyde

Perform gas calibration for tonometry and airway gas monitoring, see below.

DO NOT ! •

Do not use hypochlorite, acetone-, phenol- or ammonia based cleaners. • Do not autoclave the device or its parts. • Do not immerse any part of the device in liquids, or allow liquid to enter the interior. • Do not apply pressurized air to any outlet or tubing connected to the monitor. NOTE: For details about cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the accessory package.

More comprehensive checking

Before cleaning

See the “Technical Reference Manual.”

1. Turn off the monitor from the power switch. 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.

15

16

D-fend water trap

Other accessories

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

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

Refreshing the batteries 1. Turn on the monitor. 2. Connect the monitor power cord to power supply for at least 10 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 10 hours.

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

Changing fuses 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.

16

17

Calibrating Patient Spirometry

Calibrating

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

Calibrating gas exchange To ensure gas exchange accuracy, perform the airway gas calibration once a month and patient spirometry calibration once a year. Use 2-m (7-ft) airway gas sampling line.

Calibrating tonometry 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. 4. Close the regulator. 5. Check that the displayed values match the values on the calibration gas container. Adjust with the ComWheel, if necessary, and confirm. 6. If airway gases are monitored, calibrate the gas module at the same time.

Calibrating airway gases Follow the recommended calibration intervals (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 on the screen, open the regulator and start feeding gas. Push the ComWheel and continue feeding gas until the text 'Adjust' is displayed. 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.

Calibration check of temperature, NIBP and invasive blood pressures Calibration check of temperature, NIBP and invasive blood pressures should be performed at least once a year by qualified service personnel as a part of the Planned Maintenance, see the "Technical Reference Manual."

NOTE: Calibrate M-miniC module with calibration gas 755580 only and set the O2 concentration to 20%.

17

18

Alarm basics Enabling the alarms

Alarm indications

To enable the alarms, connect the patient cables. If the alarm 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 the 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 screen giving more detailed information. An audible alarm is also triggered. For details about alarms, see section "Alarms" in User's Guide Part II.

Alarm categories

NOTE: If the monitor is connected to the network, the alarms can be heard and seen on the S/5 Central as well. Please consult the "Datex-Ohmeda S/5 Central User's Reference Manual: Alarms" for details.

The priority depends primarily on the cause and alarm duration.

Visual

Meaning

Tone pattern (selected when the system is configured)

Front panel LED

Red

For life threatening situations

red LED lit

Yellow

For serious but not life threatening problems

White

Advisory

Triple + double beep every 5 seconds or continuous beep --- -- 5 --- --/ ----Triple beep every 19 seconds or double beep every 5 seconds --- 19 --- / -- 5 -- 5 -Single beep -

18

yellow LED blinking yellow LED lit