GE FM Userguide
GE FM Userguide
S/5
User’s Guide
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.
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Contents
Safety precautions .................................................... 3 ECG/ST...................................................................53
Symbols.................................................................... 5 Impedance respiration .............................................63
System introduction .................................................. 7 Temperature............................................................64
Monitor introduction ................................................. 9 Pulse oximetry .........................................................65
Monitoring basics.................................................... 19 NIBP .......................................................................67
Setting up the monitor before use............................. 21 Invasive blood pressure ............................................69
Starting and ending ................................................. 27 Airway gas ...............................................................73
Entering and loading patient data............................. 29 Troubleshooting.......................................................75
Screen setup........................................................... 31 Messages................................................................77
Alarms.................................................................... 33 Abbreviations ..........................................................81
Trends and snapshots .............................................. 37 Performance ...........................................................87
Printing and recording ............................................. 39 End User License Agreement ....................................91
Laboratory data and calculations ............................. 43 Warranty .................................................................92
Interfacing external devices ..................................... 47
Cleaning and care ................................................... 49
Trademarks
Datex®, Ohmeda®, and other trademarks S/5, D-lite, D-lite+, Pedi-lite,
Pedi-lite+, Mini D-fend, D-fend, D-fend+, 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.
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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.
delivered with the monitor. Other cables, batteries, transducers
Warnings and accessories may cause a safety hazard, damage the
equipment or the system, result in increased emissions or
A WARNING indicates a situation in which the user or decreased immunity of the equipment or system or interfere with
the patient may be in danger of injury or death. the measurement. Protection against cardiac defibrillator
• Connect only one patient to the monitor at a time. discharge is due in part to the accessories for pulse oximetry
• Do not use the monitor without manufacturer approved (SpO2), temperature (T) and invasive pressure (P) measurement.
mounting attached. • Single-use accessories are not designed to be re-used. Re-use
• Vibrations during intrahospital transport may disturb SpO2, ECG, may cause a risk of contamination and affect the measurement
impedance respiration, NIBP and InvBP measurements. accuracy.
• Use only hospital-grade grounded power outlets and power cord. • Do not incinerate a battery or store at high temperatures, as it
• Some equipment malfunctions may not generate a monitor will explode.
alarm. Always keep the patient under close surveillance. • The monitor or its components should not be used adjacent to or
• To avoid explosion hazard, do not use the monitor in presence of stacked with other equipment. If adjacent or stacked use is
flammable anesthetics. necessary, the monitor and its components should be observed
• Do not use the monitor in high electromagnetic fields (for to verify normal operation in the configuration in which it will be
example, during MRI.) used.
• Do not connect any external devices to the system other than • Pins of connectors identified with the ESD warning symbol
those specified. should not be touched. Connections should not be made to
• Do not touch the patient, table, instruments, modules or the these connectors unless ESD precautionary procedures are
monitor during defibrillation. used. See the "User’s Reference Manual" for details.
• If the integrity of the external protective earth conductor • The system may be interfered with by other equipment, even if
arrangement is in doubt, use the monitor with battery operation. that other equipment complies with CISPR emission
• After transferring or reinstalling the monitor, always check that it requirements.
is properly connected and securely attached. • If liquid has accidentally entered the equipment, disconnect the
• When detaching modules, be careful not to drop them. Always power cord from the power supply and have the equipment
support with one hand while pulling out with the other. serviced by authorized service personnel.
• Use only accessories, including mounts and batteries, and • If the unit fails to respond as described, do not use the monitor
defibrillator-proof cables and invasive pressure transducers until tested and repaired by authorized service personnel.
approved by Datex-Ohmeda. For a list of approved supplies and
accessories, see the “Supplies and Accessories” catalog
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Symbols
Attention, consult accompanying documents. When displayed in the upper left corner of the screen, indicates
When displayed next to the HR value, indicates that the pacer that the alarms are silenced. When displayed in the menu or digit
is set on R or a wide QRS is selected. fields, indicates that the alarm source has been turned off or
On the E-PSM(P) module indicates that protection against alarm does not meet the alarm-specific activation criteria.
cardiac defibrillator discharge is due in part to the accessories Equipotentiality. Monitor can be connected to potential
for pulse oximetry (SpO2), temperature (T) and invasive equalization conductor.
pressure (P) measurement.
On the rear panel this symbol indicates the following warnings
Alternating current
and cautions:
- Electric shock hazard. Do not open the cover or the back.
Fuse. Replace the fuse only with one of the same type and rating.
Refer servicing to qualified personnel.
- For continued protection against fire hazard, replace the fuse
only with one of the same type and rating. In the front panel: battery.
- Disconnect from the power supply before servicing.
- Do not touch the monitor during defibrillation procedure.
- Do not use the monitor without manufacturer approved Battery operation and remaining capacity. The height of the
A
B B
mounting attached. green bar indicates the charging level.
- Lithium battery on CPU board: follow the regional regulations
for disposal.
Battery (A) charging (white bar).
B
Type BF (IEC 60601-1) protection against electric shock.
Type CF (IEC 60601-1) protection against electric shock. Both batteries failed.
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In the front panel: mains/external DC power. Submenu. Selecting a menu item with this symbol
opens a new menu.
Wireless LAN signal strength. The number of segments The monitor is connected to the Datex-Ohmeda S/5
corresponds to the signal strength: four segments indicate Network (Local Area Network).
strong signal, one segment weak signal. When connection to
access point is being searched, the segments scroll from zero
to four and back. The monitor is connected to the Datex-Ohmeda S/5
Network (Wireless Local Area Network).
ESD warning symbol for electrostatic sensitive devices. Pins of
connectors identified with the ESD warning symbol should not Data Card (green) or Menu Card (white) is inserted
be touched. Connections should not be made to these
connectors unless ESD precautionary procedures are used. A blinking heart next to the heart rate or pulse rate value
See "Safety precautions: ESD precautionary procedures" in indicates the beats detected.
the "User’s Reference Manual" for details.
A lung next to the respiration rate value indicates that
respiration rate is calculated from the impedance
Symbol for non-ionizing electromagnetic radiation. respiration measurement.
Interference may occur in the vicinity of equipment marked
with this symbol.
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System introduction
(1) S/5 FM with module(s)
(2) S/5 Remote Controller, K-CREMCO
1 2
(3) Printer 3
(4) Other monitors in the Network
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. 4
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Monitor introduction
1 2 3
4 (1) Battery compartment, see page 13
(2) Transportation handle
(3) Alarm light, see page 33
(4) Alarm LEDs, see page 33
(5) Side panel keys, see page 12
(6) The ComWheel
5 (7) Command Board keys, see page 10
(8) Guide rail for GCX mounting
14 (9) Mains power and battery LEDs, see page 13
(10) ON/standby key
13 (11) Connector for the Device Interfacing Solution (marked with X6)
6 (12) Connector for defibrillator synchronization (marked with X5)
(13) Measurement modules, see page 15
(14) Slot for Data Card or Menu Card
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(1) ON/standby key (7) For returning the Normal Screen view to the screen
(2) Mains power ON (lit) or OFF (dark): indicates mains or external (8) For activating pulse oximetry, impedance respiration and
DC power temperature setup menus
(3) For admitting or discharging a patient; for selecting user modes; (9) For printing and recording different trends and views
for viewing data from other monitors; for activating standby (10) For selecting pages and for activating the ECG View or the ST
(4) For viewing trends, alarm history and other patients, and for View
activating the Lab Data and the Drug Calculator menu (11) For setting up the monitor and for activating the HELP menu
(5) For creating snapshots (12) Battery operation LEDs, see page 13
(6) For activating parameter specific menus. NOTE: All modules do
not measure all of these parameters. For more information, see
page 15.
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Alarms
Setup For activating the Alarms Setup menu, see page 33
Invasive Pressures
NIBP
Start
Cancel For starting or stopping the NIBP manual cycling, see page 67
Recorder
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Batteries
The S/5 FM has two lithium-ion batteries, located in the battery NOTE: Always use the S/5 FM with batteries inserted. Otherwise all
compartment. They can be charged separately, and screen symbols trend data, snapshots and temporary settings are lost if the power
and monitor frame LEDs indicate their charging level and possible cable is detached from the mains. NOTE: When the monitor is battery
failure, see table below. You can also check the battery status through powered, the green battery LED is on. When the monitor is mains
Monitor Setup – Battery Setup. powered, the green mains LED is on. See also sections
"Conditioning the batteries" and "Messages."
Battery indicators Checking the battery charge when the monitor is turned off
Screen Explanation Front panel
symbol battery LED indicators
Monitor is battery powered. Green lit When the monitor is turned
A
B B Batteries are fully charged; the Orange dark off, you can check the
size of the green bar indicates the
battery charging level by
charging level.
pressing the test button on
Monitor is battery powered. Green lit the battery as indicated in
A B Battery A is empty, battery B is Orange dark
ok.
the drawing on the left. The
green bar lights up and the
Monitor is battery powered. Green lit
B Battery A failure, battery B is ok.
number of lit segments
Orange flashing indicates the charging level.
NOTE: If both batteries fail, the green battery LED is dark.
Monitor is battery powered. Green lit
B Battery A missing, battery B is ok. Orange flashing
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To replace a battery:
A
B
1. Open the lid of the battery compartment located 2. Lift up the battery you want to change. 3. Push in the new battery. Make
behind the transportation handle by sliding it to the left. Check the indicators and messages on sure that the charging indicator
screen to make sure that you change the is facing forward and push the
battery with lower charge. battery down all the way. Check the
monitor indicators, see above.
CAUTION: After replacing a battery, always make sure to close the battery compartment by sliding the lid back to the right
until it clicks.
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Measurement modules You can use simultaneously either one E-PSM(P) module or one
There are five modules for the S/5 FM: hemodynamic Patient Side N-Fx module or one of each. See the following pictures and
Modules E-PSM and E-PSMP, and the S/5 FM specific Extension explanations for module features.
Modules N-FREC, N-FCREC and N-FC.
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N-FC:
- CO2 measurement
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Removing a module
1. Pull the module outwards using the tab. Make sure not to
drop it when it comes out.
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Monitoring basics
Navigating in menus Using pages
A menu is a list of functions or commands. To display a menu, press Each user mode has six configurable pages. Also pages contain
one of the hard keys. Selections in the menus are made with the different sets of parameters. In addition to the Normal Screen page,
ComWheel. For example, to change the ECG display: some modes have factory defaults for one or more other pages.
• Press the ECG key to open the function menu.
• Turn the ComWheel to select the desired function in the menu. For more information, see the “Default Configuration Worksheet” or
• Push the ComWheel to open a submenu or an adjustment the “User’s Reference Manual.”
window.
• Push the ComWheel to confirm the selection. Selecting an appropriate page
In addition to the Normal Screen, you can define up to five more
Using modes pages for each mode. Pages are preconfigured but if desired, can
The S/5 FM has six user modes. These user modes are predefined also be changed. To select a page:
sets of parameters. They determine, for example, what is displayed on 1. Press the Pages/Views key or push the ComWheel once in the
the screen and in trends and what the alarm limits are. In other words, Normal Screen view.
by choosing a specific mode you get suitable settings on the screen 2. Select the page with the ComWheel.
without having to choose all features one by one.
For more information, please refer to section "Setting up the monitor
Modes can be hospital specific. The monitor starts in start-up mode, before use."
which is one of the user modes chosen during configuration. The
default modes are STEP-DOWN, ED, PACU, CCU, NEURO and
PEDIATRIC. 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."
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Passwords
The default password for entering the Install/Service menu is Setting time and date
16 4 34. NOTE: If the monitor is connected to the S/5 iCentral, it follows the
iCentral’s time settings and the Time and Date menu is not available.
The default password for entering the Save Modes menu is NOTE: You cannot change the monitor’s time settings after the patient
13 20 31. has been admitted.
1. Press Monitor Setup and select Time and Date.
Interfacing 2. Turn and push the ComWheel to set the time and date.
1. Press Monitor Setup and select Interfacing.
2. Select the desired interfaced external devices.
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You can change temperature units through Others - Temp Setup and
CO2 units through Airway Gas - CO2 Setup. The changes are Display setup
permanent. LCD Colors: Change the number of colors on the LCD display.
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Changing the Normal Screen layout Changing the layout of other pages
1. Press Monitor Setup and select Screen 1 Setup: You can check the contents of the pages by pressing the
• Waveform Fields: Select the displayed waveforms. Pages/Views key. To change the layout of the pages:
• Digit Fields: Change the contents of a field or turn it off. 1. Press Monitor Setup.
• Split Screen: Select what you wish to display with the waveforms 2. Select Install/Service - Pages Setup.
(ST, Trend or None). 3. Select the page and make the changes.
• Minitrend Length: Select the length of the minitrend.
Changing the display brightness
1. Press Monitor Setup and select Display brightness.
2. Select from 10 to 100 %.
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Setting the default trend Setting trend length and time scale
You can select graphical or numerical trends to be displayed by 1. Press Pt.Data & Trends:
default. • Select Trends – Graphical - Time Scale and the value.
1. Press Monitor Setup and select Install/Service - Trends & • Select Trends - Graphical - Trend Scales and adjust the scales.
Snapshot.
2. Select Default Trend and Graph or Num.
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WARNING: Connect only one patient to the monitor at a The patient admission happens through Admit Patient selection or
time. automatically when the monitor receives a patient's vital signs.
Always observe the monitor and the patient carefully during start-up
WARNING: Always make sure that necessary alarm periods.
limits are active and set according to the patient's
clinical condition when you start monitoring a patient.
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Alarms are activated. The previous data is retrieved and the monitor
starts collecting new data. NOTE: Zero invasive pressure lines.
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Screen setup
Modifying the screen temporarily Changing the split screen contents
• Press the Monitor Setup key and select Screen 1 Setup. You can split the Normal Screen page into two parts. The other half of
the split screen shows trend or ST data.
Change the waveform and digit field measurements, split screen
option, minitrend length and sweep speeds. 1. Press the Monitor Setup key.
• To make other setup changes, such as scale changes, press a 2. Select Screen 1 Setup.
parameter key and select its setup menu. For example, press the 3. Select Split Screen and choose from the options.
ECG key and select ECG Setup. • ST shows current and reference QRS complexes and ST trends.
• Trend shows minitrends beside waveforms.
Changes are valid until the monitor is turned off (+15 minutes) or until
• None shows no split screen.
you discharge the patient from the monitor. Only time and date
settings are stored permanently.
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Note that:
- Waveforms are always evenly spread to fill the entire waveform
area. When 3 or fewer waveforms are displayed, the waveforms
are displayed in an enlarged format.
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Alarms
Enabling the alarms Alarm indications
To enable the alarms, connect patient cables. If the alarm source is When the monitor is turned on, you will hear a beep: this tells you that
selected, the alarms are operative also when the measurement is not the alarm audio signal is working. Also, the alarm LED indicators light
displayed (except the respiration measurement alarms). up for a few seconds. To check them, see “Cleaning and
care:Functioning of the alarms.” You can also check the functioning of
WARNING: Always make sure that necessary alarm the audio signal and alarm light through Alarms Setup - Alarm
limits are active and set according to the patient's Volume or Alarm Light.
clinical condition when you start monitoring.
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, and the alarm LEDs
on the monitor side panel indicate the alarm level. If enabled, also
the alarm light flashes red or yellow according to alarm levels, see
below.
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Alarm categories
The priority depends primarily on the cause and alarm duration.
Visual Meaning Tone pattern (selected when the Side panel LED indicators Alarm light
system is configured) (if enabled)
Red For life threatening situations Triple + double beep every 5 seconds or red LED lit flashing red
continuous beep
--- -- 5 --- --/ -----
Yellow For serious but not life Triple beep every 19 seconds or double beep yellow LED blinking flashing yellow
threatening problems every 5 seconds
--- 19 --- / -- 5 -- 5 --
White Advisory Single beep - yellow LED lit dark
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Alarm light
The S/5 FM has an alarm light, located in the upper right corner of Showing alarm history
the monitor frame, see page 9. The alarm light can be enabled • Press the Pt.Data & Trends key.
(default) or disabled through Monitor Setup - Install/Service - • Select Alarm History. A list of the last 20 alarms is displayed.
Installation– Alarm Options- Alarm Light. When enabled, it flashes
red or yellow according to the currently active highest priority alarm.
To adjust the brightness of the light:
1. Press the Alarms Setup key.
2. Select Alarm Light and adjust with the ComWheel. During
adjustment the light is on to help you determine a suitable
brightness level.
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Symbols
Trends view Trend bar: the gap shows the mean value.
(1) Trends menu
(2) Measurement trend field
NIBP trend bar
(3) Real time ECG
(4) Numerical value of a measurement at the trend cursor point Indicator of change -for example, ST relearning or zeroing of
(5) Time and marker field an invasive blood pressure channel
(6) Trend page number
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NOTE: You can also print the calculations through Wedge C.O. –
Calculations – Hemodynamic Calcs or Oxygenation Calcs – Calc.
Trends – Print Page.
To print all calculations:
1. Press the Print/Record key.
2. Select Print Calcs.
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NOTE: The drug list can be saved to and loaded from the network or
Menu Card with the modes. However, it is not mode dependent.
NOTE: Infusion rate calculations may require the patient weight. Enter
it by selecting Demographics in the Drug Calcs menu.
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CAUTION: Make sure that the interfacing module is always NOTE: The device appears on the list only if it is correctly connected.
used in vertical position to prevent water from entering the
module.
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Before cleaning
1. Turn off the monitor from the ON/standby key. Conditioning the batteries
2. Disconnect the power cord. Condition batteries regularly to maintain their useful life. Condition a
After cleaning battery every six months or when the message ‘Replace Battery A’
1. Let dry completely. appears on the screen. Always observe the messages and symbols on
2. Reconnect the power cord and turn on the monitor. the screen to see the battery status. You can also check the status
through Monitor Setup – Battery Setup. For more information, see
More comprehensive checking
sections "Replacing the batteries", "Symbols" and "Messages."
See the “Technical Reference Manual.”
Conditioning a battery is best done on an external charger. To do this,
WARNING: After cleaning or if liquid has accidentally please, refer to the "User’s Reference Manual."
entered the monitor, ensure that every part of the
monitor is dry before reconnecting it to the power
supply. Power interruption
NOTE: Always use the S/5 FM with batteries inserted. Otherwise all
trend data, snapshots and temporary settings are lost if the power
Water trap in the N-FCREC and N-FC modules cable is detached from the mains.
• Empty the container whenever half full. If the monitor is in standby or turned off, trend data and the latest
• Change the water trap every two months and when the text user-made settings remain in the monitor memory for 15 minutes
‘Replace D-Fend’ appears. even if the mains power is interrupted. After 15 minutes, trend data is
• The water trap cartridge is disposable. Do not wash or reuse the lost and the monitor returns to the user default settings (start-up
cartridge. mode).
Other accessories
For information on how to clean and check reusable accessories, see Changing fuses
the accessory package or the “Supplies and Accessories” catalog. Do 1. Remove the power cord if used.
not reuse single-use disposable accessories. 2. Remove the fuse holder by pushing the locking pin and pulling the
holder gently out, see also page 10.
3. If a fuse is blown, replace it with a fuse of the correct type and
rating.
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Regular checks
ECG NIBP
• Check that the ECG waveforms are displayed when the cable is • Ensure that you are using correct cuff size and have selected
connected to the patient. When the cable is disconnected from correct inflation limits.
the patient, the message 'Leads off' is displayed. • Check that the cuff hose detection (Adult/Infant) works properly.
Impedance respiration • Check that the pump is not restarting in Venous Stasis mode. If it
• Check that the impedance respiration waveform is displayed does, there may be a leakage in the cuff.
when the cable is connected to the patient. When the cable is • Check that the pressure values are displayed.
disconnected from the patient, the message 'Leads off' is Airway gases
displayed. • Check that the ‘Sample line blocked’ message appears within 30
Pulse oximetry seconds after you have occluded the airway adapter, and gas
• Check that the sensor is functioning when connected to the waveforms are showing zero at the same time.
measurement site. • Check that the water trap is empty.
• Check that the SpO2 value is displayed. When the sensor is
disconnected from the patient, the message 'SpO2 probe off' is Functioning of the alarms
displayed. • Set a parameter value outside the alarm limits. For example,
Temperature connect the SpO2 sensor and adjust the SpO2 High limit under
• Check that the temperature value is displayed when the probe is the measured SpO2values. The alarms go from white to red
connected to the patient. according to sequence given in the “Alarm categories” table on
InvBP page 34.
• Check that the yellow and red LEDs function as indicated in the
• Check that the monitor recognizes cable connections (activates
table.
the display) for all the pressure channels used and the pressure
values are shown. • Check that the alarm light functions if it is enabled, see page 35.
• Make sure that the zeroing of all the transducers is working
correctly. The message 'No P1 transducer' or 'No P2 You can also use the same method for checking other parameters,
such as ECG and CO2.
transducer' is displayed when the invasive pressure transducer
or channel P1 – P2 cable is disconnected.
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Calibrating
Calibration check of temperature, NIBP and invasive blood 1. Turn on the power. Let the monitor warm up for 30 minutes.
pressures 2. Attach a regulator to the calibration gas container.
Calibration check of temperature, NIBP and invasive blood pressures 3. Attach a new sampling line to the water trap. Connect the other
should be performed at least once a year by qualified service end of the sampling line to the regulator on the gas container.
personnel as a part of the Planned Maintenance, see the “Technical 4. Press the Airway Gas key and select Gas Calibration.
Reference Manual." 5. 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
Calibrating airway gases displayed.
Follow the recommended calibration intervals (every six months in 6. Check that the displayed gas values match the values on the
normal use and every two months in continuous use) to ensure that calibration gas container. Adjust with the ComWheel, if necessary.
the measurement accuracy remains within specifications.
NOTE: See the “Supplies and Accessories” catalog delivered with the
monitor 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.
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ECG/ST
You need NOTE: For a comprehensive list of accessories, see the “Supplies and
(1) E-PSM or E-PSMP module Accessories” catalog delivered with the monitor.
(2) Multi-Link 5-lead or 12-lead standard cable
NOTE: In 5-lead ECG, place the 5th electrode (C/V) in one of the six
(3) Multi-Link leadwire set (3 or 5 leads) places indicated, and select the corresponding V lead label.
(4) Multi-Link leadwire set (C2-C6 IEC, V2-V6 AHA) In 12-lead ECG, C/V is the same as C1/V1.
NOTE: For 3-lead ECG, you can also use the Multi-Link 3-lead ECG WARNING: Vibrations during intrahospital transport
cable with integrated leadwires. may disturb ECG measurement.
ECG electrodes (pre-gelled electrodes are recommended).
Check the expiration date.
LEAD III
LE 1 2
AD 3 6
II 4 5
F/LL
N/RL F/LL
1 F=GREEN (IEC)
LL=RED (AAMI)
N=BLACK (IEC)
RL=GREEN (AAMI)
F=GREEN (IEC)
LL=RED (AAMI)
RL
2
RA
RA LA
LA
LL
V
3
1 2
34 V1
56
V2
4
V3
V4
V5
RL LL
V6
2
3
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Connecting ECG leadwire sets to ECG trunk cables 12-lead placement according to Mason-Likar
• For 3-lead ECG, connect the Multi-Link 3 leadwire set to the • The arm leads are located just below the clavicles in the
5- or 12-lead standard cable. You can also use the Multi-Link 3- infraclavicular fossae.
lead ECG cable with integrated leadwires. • The lower limb leads are located just above the iliac crests.
• For 5-lead ECG, connect the 5 leadwire set to the 5- or 12-lead • The six precordial leads (chest leads) are positioned as follows:
standard cable. - V1 is placed in the fourth intercostal space to the right of the
• For 12-lead ECG, connect the 5 leadwire set together with the sternum.
C2 – C6 or V2 – V6 leadwire set to the 12-lead standard cable. - V2 is placed in the fourth intercostal space to the left of the
sternum.
- V3 is placed between V2 and V4.
WARNING: Make sure that the leadwire set clips or - V4 is placed in the fifth intercostal space in the
snaps do not touch any electrically conductive material midclavicular (1) line.
including earth. - V5 is placed between V4 and V6 same horizontal level as V4.
- V6 is placed in the fifth intercostal space in the midaxillary (2)
line, same horizontal level as V4 and V5.
(1)
Midclavicular line = A line that runs vertically downward from the
midpoint of the clavicle.
(2)
Midaxillary line = A line that runs vertically downward from a point
situated midway between the dorsal and ventral boundaries of the
axilla.
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Preparing the patient and applying the electrodes Selecting the number of electrodes
1. Prepare the skin properly to ensure optimal signal quality: 1. Press the ECG key.
• Shave any hair from the electrode sites. 2. Select ECG Setup.
• Gently rub the skin surface to increase capillary blood flow 3. Select 5-lead Cable - 3elect or 5elect.
and remove dead skin cells and oil.
• Clean the skin using a mild soap and water solution. With 12-lead ECG, the electrode selection is automatic.
• Dry the skin completely before applying the electrodes.
2. Apply the electrodes (see figures and instructions above). Avoid Selecting the user leads
bones close to the skin, obvious layers of fat and major muscles. 1. Press the ECG key.
2. Select a lead for ECG1 Lead, ECG2 Lead or ECG3 Lead.
Selecting the ECG filter
With 3-lead ECG, you can select only one user lead (ECG1 Lead).
1. Press the ECG key. With 5- and 12-lead ECG, you can select three user leads.
2. Select ECG Setup - Filter:
STfilt filters high-frequency artifacts but catches slow ST changes.
Monit filters high-frequency artifacts and slow ST changes. Selecting a label for V Lead
NOTE: No ST analysis. With 5-lead ECG, one V lead is measured according to the placement
Diagn catches high-frequency changes and slow ST changes. of the V lead electrode. To select a label for the lead:
1. Press the ECG key.
2. Select ECG Setup - V Lead.
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NOTE: The module input circuits are protected against the effects of Selecting what to display with HR
electrosurgery and defibrillation. However, the ECG trace on the You can select what is displayed with heart rate:
monitor screen may be disturbed during electrosurgery.
1. Press the ECG key.
Displaying ECG grid 2. Select ECG Setup.
3. Select Display with HR - PR/PVC/None.
To view the ECG waveforms over gridlines on the screen:
Printing ECG
• Press the ECG key and select ECG Setup - Grid - ON. To view
To print all ECG waveforms on a laser printer:
without gridlines, select OFF.
1. Press the ECG or Pages/Views key.
2. Select ECG View.
3. Select Print Page.
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Arrhythmia monitoring
NOTE: For optimal results, select STfilt as the ECG filter. For details, see page 55.
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Monitoring ST
The monitor analyzes ST for all measured leads and gives ST trends separately for each lead. The ST analysis starts automatically after the leads have
been connected, the QRS detection has started and the ECG filter selection is either STfilt or Diagn. ST can be viewed as digits, average and reference
complexes and trends. For details about detection performance and test results of ST segment measurement algorithm testing, see the "User’s
Reference Manual: ECG."
NOTE: ST segment changes may also be affected by such factors as some drugs or metabolic and conduction disturbances.
NOTE: The significance of the ST segment changes needs to be determined by a clinician.
ST View
To get the ST View on screen:
1. Press the ECG or Pages/Views key.
2. Select ST View.
ST number field with four ST values: three
from the user leads and one from the lead
with the largest absolute ST value.
The current average complex (indicated
here with black) for each lead with lead ID
and ST value, together with the reference
complex (indicated here with gray) and
markers of the three measurement points
ISO point, J point and ST point.
The first reference complex is saved
automatically and displayed by default. You
can save manually up to six reference
complexes. (See below.)
NOTE: For optimal results, select STfilt as the ECG filter. With Monit filter the ST analysis is not Minitrends for the three user leads. You
available. can select the scale:
ISO point is on the isoelectric line. -2...+2 mm; -5...+5 mm; -9...+9 mm
J point is the point on the ECG trace where the S wave transitions to the ST segment.
ST segment is the component of the ECG trace between the end of the QRS complex and the T wave.
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Studying ST Trends
Viewing ST in split screen
• Press ECG or Pages/Views and select ST View - ST Trends.
• Press Monitor Setup and select Screen 1 Setup- Split Screen -
QRS complexes and trends for the three user leads are displayed
ST. The split screen shows current QRS complexes, reference QRS
by default. HR trend is also displayed.
complexes and ST trends.
• To see complexes and trends for other leads, select Leads and
Viewing current and reference ST complexes in ST View then User, Lat., Inf. or Ant.
• To check the saved average complex for the displayed leads,
• Press ECG or Pages/Views and select ST View. select Cursor and move the trend cursor with the ComWheel to
• To show only the data area, select Remove Menu. the desired time point indicated in the time scale. When you stop,
the ST value of the moment indicated by the trend cursor is
Selecting a reference complex from memory displayed next to it, and the saved average complex is drawn
• In ST View, select Ref. QRS, scroll to the time of the desired behind the current QRS complex.
reference complex saved in the memory and push the ComWheel.
Changing the time scale
Saving the current complex as the new reference complex NOTE: The time scale setting affects the ST Trends window, ST split
• In ST View, select Save New QRS. The current QRS is saved and screen trends, ST View trends and the length of the printed reports.
displayed as the reference complex. You can save up to six • Press ECG or Pages/Views, and select ST View - ST Trends -
reference complexes. Time Scale.
NOTE: If the memory is full and you do not erase a complex before
saving a new one, the oldest manually saved complex is deleted. Displaying ischemic burden in ST Trends
• To erase a saved reference complex, select Erase QRS, scroll to NOTE: Available only if the Isch. Burden has been selected ON.
the time of the reference complex to be erased and push the • Press ECG and select ECG Setup – Ischemic Burden - ON. In an
ComWheel. You cannot erase the first automatically saved ischemic episode, the ST value falls outside the threshold limits.
reference complex. The area between the threshold limit and the ST trend is yellow.
Adjusting measurement points • To change the limits, press ECG and select ST View - ST Trends
and adjust Elev. Limit or Depr. Limit.
• In ST View, select Adjust ST.
• Adjust the points by selecting Set ISO point, Set J point or ST Printing ST reports
point (where the value is the delay between J-point and ST-point In ST View, select Print QRS/ST. The length of the report is the same
in milliseconds). as the time scale selected in ST Trends.
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Impedance respiration
You need
− The same setup as in the ECG measurement, see section Correcting the respiration number
"ECG/ST." Normally, the AUTO detection limit is recommended. However, if the
respirations are particularly weak or affected by artifacts, they may
Starting not be included in the respiration rate. To ensure the correct
1. Select respiration in a waveform or a digit field, otherwise the respiration number, adjust detection limits closer to each other.
respiration data is not included in the trends and no alarms are 1. Press the Others key.
activated. 2. Select Resp Setup - Detection Limit.
2. Turn on the measurement: 3. Adjust the limits.
• Press the Others key.
WARNING: This device is not an apnea monitor system
• Select Resp Setup. intended to alarm primarily upon the cessation of
• Select Measurement and ON. breathing. In central apnea it indicates an alarm after a
NOTE: Impedance respiration measurement is intended for patients pre-determined time since the last breath detection. Do
over three years old. not attempt to use it for detecting obstructive or mixed
apneas, since respiration movements and impedance
Improving waveform readability variations may continue in these cases.
1. Press the Others key. WARNING: Vibrations during intrahospital transport
2. Select Resp Setup. may disturb impedance respiration measurement.
3. Select Size and adjust the waveform size. WARNING: Make sure that the leadwire set clips or
snaps do not touch any electrically conductive material
For more information, see the “User’s Reference Manual.” including earth.
WARNING: When using the electrosurgery unit, ensure
proper contact of the ESU return electrode to the
patient to avoid burns at monitor measurement sites.
WARNING: The impedance respiration measurement
may cause rate changes in Minute Ventilation Rate
Responsive Pacemakers. Set the pacemaker rate
responsive mode off or turn off the impedance
respiration measurement on the monitor.
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Temperature
(1) E-PSM or E-PSMP module
(2) Adapter cable for 3
temperature probes
(3) Reusable temperature 1
probe
(4) Adapter cable for 3
disposable temperature 2
probes
(5) Disposable temperature 5
probe
NOTE: Use only Datex-Ohmeda 4
temperature probes or
defibrillator-proof YSI 400 series
probes.
NOTE: For a comprehensive list
of accessories, see the “Supplies
and Accessories” catalog
delivered with the monitor.
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Pulse oximetry
You need NOTE: For each SpO2 accessory, refer to the instructions for use in the
(1) E-PSM or E-PSMP module accessory package for patient weight limits.
(2) OxyTip+ interconnect cable WARNING: Allow sensor and cable to dry completely
after cleaning. Moisture and dirt on the connector can
NOTE: For a comprehensive list of accessories, see the “Supplies and affect the measurement accuracy.
Accessories” catalog delivered with the monitor. WARNING: Vibrations during intrahospital transport
may disturb SpO2 measurement.
OXY-E-UN
OXY-SE-3
OXY-F-UN
1
2 OXY-W-UN
OXY-AP OXY-AF
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NIBP
You need NOTE: For a comprehensive list of accessories, see the “Supplies and
(1) E-PSM or E-PSMP module Accessories” catalog delivered with the monitor.
(2) Cuff hose
(3) Cuff of correct size WARNING: Vibrations during intrahospital transport
may disturb NIBP measurement.
WARNING: Non-invasive blood pressure measurement
is intended for patients weighing over 5 kg (11 lb).
2
Over brachial
artery 3
X LINE
INDE
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1
7
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LABEL P1, Art, ABP P2, CVP RAP, LAP ICP PA RVP
Scale 200 20 20 20 60 60
Color Red Blue White White Yellow White
Alarm source Sys Off Off Off Off Off
Digit format S/D Mean Mean CPP S/D S/D
Filter 22 9 9 9 9 9
Response Normal Normal Normal Normal Normal Normal
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Adjusting PCWP
Pulmonary Capillary Wedge Pressure (PCWP) To manually adjust the wedge pressure level:
Starting 1. In the Wedge menu, turn the ComWheel to move the cursor to a
1. Prepare the pulmonary artery catheter and use the distal lumen point that represents the true PCWP level.
for the pressure line. 2. Push the ComWheel and select Confirm.
2. Label the wedge pressure channel 'PA'.
3. Check that the monitor has correct information about the Canceling the PCWP measurement
patient’s ventilation: Invasive Pressures - Ventilation Mode – • In the Wedge menu, select Cancel.
Contrl (controlled ventilation) or Spont (spontaneous breathing).
4. Press the Invasive Pressures key and select Wedge Pressure. WARNING: Vibrations during intrahospital transport
5. Select Measurement. may disturb InvBP measurement.
6. When ‘Inflate the balloon’ is displayed, inflate the catheter WARNING: All invasive procedures involve risks to the
balloon. The monitor automatically freezes the waveform for 20 patient. Use aseptic technique. Follow catheter
seconds. manufacturer's instructions.
7. When ‘Deflate the balloon’ is displayed, deflate the catheter
WARNING: Make sure that no part of the patient
balloon. connections touches any electrically conductive
NOTE: During the wedge pressure measurement, PA values are not material including earth.
trended and PA alarms are disabled. WARNING: When using the electrosurgery unit, ensure
proper contact of the ESU return electrode to the
patient to avoid burns at monitor measurement sites.
WARNING: Use only defibrillator proof transducers and
cables.
WARNING: Mechanical shock to the invasive blood
pressure transducer may cause severe shifts in zero
balance and calibration, and cause erroneous
readings.
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Airway gas
You need You get
− N-FCREC or N-FC module with CO2 measurement capability Carbon dioxide measurement: EtCO2, FiCO2, capnogram.
− Gas sampling line Respiratory rate
− Airway adapter with sampling line connector
− Water trap
NOTE: For a comprehensive list of accessories, see the “Supplies and
Accessories” catalog delivered with the monitor.
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Troubleshooting
NOTE: Always check the patient’s condition first in problematic situations or if an alarm is triggered. See also section “Messages." Also note that if the
measurement or function does not appear on the screen, check module connections.
PROBLEM RELATED TO: CAUSE WHAT TO DO
Airway gases Airway gas values are too low • Check the sampling line and connectors for leakage.
Extra arrhythmia are detected The morphology of the ECG signal has changed.
• Start relearning manually through ECG - Relearn.
Arrhythmia Patient's medical condition.
Extra Ventricular Fibrillations are • Check the patient.
detected Low amplitude signal in some ECG leads.
• Leads I and II: Select the one with the largest amplitude to ECG1.
• Leads C1-C6 (V1-V6): Select the one with the largest amplitude to
ECG2.
• After selecting the leads, start relearning manually.
Batteries Battery operation time is markedly • Condition batteries (see section “Conditioning the batteries”).
shortened
• Ensure that the patient is not shivering.
• Select the correct filter by pressing ECG and selecting ECG Setup - Filter.
ECG signal is noisy or no QRS is • Check the electrode quality and positioning. Do not place them on body
ECG detected hair, bones close to skin, layers of fat and major muscles. Pre-gelled
electrodes are recommended.
• Change the lead.
• Remove the ECG cable from the module and reinsert it.
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Temperature Temperature measurement fails • Check that you are using a correct probe.
• Try another probe.
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Messages
MESSAGE CAUSE WHAT TO DO
Air leakage NIBP: There is an air leak in the cuff or hose. Check all connections and test tightness using
venous stasis.
Alarms acknowledged from Silenced alarms remain silent. New alarms will have an If required, turn on the alarms through Alarms
Central audible sound. (Can also be done using the iCentral). Setup – Audio ON/OFF – Activate Alarms.
Alarm setup changed from Alarm limits or arrhythmia alarm priorities have been Check the alarm limits and the arrhythmia alarm
Central changed using the iCentral. priorities – see sections "Alarms" and "ECG.”
Alarms silenced from Central Alarms have been silenced using the iCentral. If required, turn on the alarms through Alarms
Setup – Audio ON/OFF – Activate Alarms.
Apnea No breath detected for 20 seconds (respiration or CO2 Check the patient status.
measurement). Check the ventilator and breathing circuit.
Apnea deactivated Apnea alarm is silenced but will activate after five If required, turn on the alarms through Alarms
breaths. Setup – Audio ON/OFF – Activate Alarms.
Artifacts Patient movements, shivering, deep breathing, Calm the patient. Start a new measurement, if
arrhythmia or irregular beats may cause some applicable.
measurements to fail.
Asystole No QRS detected in ECG. Check the patient status. Check the electrodes.
Batt. low About 20 minutes of battery operating time left. Replace the battery, see section “Replacing the
batteries”, or connect the monitor to the mains.
Brady HR is equal to or below the lower alarm limit. Check the patient status.
Calibr.error Gases: Unsuccessful gas calibration. Perform a new calibration.
Check D-Fend Gases: The water trap connection is wrong. Check that the water trap is properly attached to
the module.
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Abbreviations
/min beats per minute, breaths per ATPD atmospheric/ambient c calculated/derived value
minute temperature and pressure, dry C chest
°C Celsius degree gas C(a-v)O2 arteriovenous oxygen content
°F Fahrenheit degree ATPS ambient temperature and difference
µg microgram pressure, saturated gas C.I. cardiac index
A alveolar aw airway C.O. cardiac output
A arm (describing location) AV atrioventricular cal. calibration
a arterial aVF left foot augmented lead Calc calculated/derived value
a/AO2 arterio-alveolar PO2 ratio Avg. average Calcs calculations
AA anesthetic agent aVL left arm augmented lead CAM Compact Anesthesia Monitor
AaDO2 alveolo-arterial oxygen aVR right arm augmented lead CaO2 arterial oxygen content
difference Axil axillatory temperature Casc. cascaded (ECG)
AAMI Association for the cc cubic centimeter
Advancement of Medical BAEP brainstem auditory evoked CCCM Compact Critical Care Monitor
Instrumentation potential CCM Critical Care Monitor
ABG arterial blood gases Bal balance gas CCO continuous cardiac output
ABP arterial pressure
bar 1 atmosphere CcO2 capillary oxygen content
ADU Anesthesia Delivery Unit
Beta, BE beta frequency band CCU cardiac (coronary) care unit
AEP auditory evoked potential
Bigem. bigeminy CEL Celsius degree
AirW airway temperature
BIS bispectral index CISPR International Special
Alpha, Al alpha frequency band
Blad bladder temperature Committee on Radio
AM Anesthesia Monitor
Blood blood temperature (C.O. Interference
Amp amplitude
measurement) cmH2O centimeter of water
Ant. anterior
Body body temperature CMRR common mode rejection ratio
APN apnea
BP blood pressure CO carbon monoxide
Arrh. arrhythmia
Brady bradycardia CO2 carbon dioxide
Art arterial pressure
BSA body surface area COHb carboxyhemoglobin
ASY asystole
BSR burst suppression ratio Compl compliance
ATMP atmospheric pressure
B-TO-B beat-to-beat Cont. continuous
BTPS body temperature and Contrl controlled ventilation
pressure, saturated gas
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HME heat and moisture exchanger ISO International Standards MAC minimum alveolar
HMEF heat and moisture exchanger Organisation concentration
with filter Iso isoflurane Max maximum
hPa hectopascal IVR idioventricular rhythm mbar millibar
HR dif heart rate difference J joule mcg microgram
HR heart rate mean mean blood pressure
ht height K kelvin mEq milliequivalent
HW hardware kcal kilocalorie MetHb methemoglobin
Hz hertz kJ kilojoule MF median frequency
kPa kilopascal mg milligram
I:E inspiratory-expiratory ratio Min minimum
IABP intra-aortic balloon pump L left (describing location) min minute
IC inspiratory capacity L leg (describing location) ml milliliter
ICP intracranial pressure L, l liter MLAEP middle-latency auditory
ICU intensive care unit l/min liters/minute evoked potential
ID identification Lab laboratory mmHg millimeters of mercury
IEC International Electrotechnical LAN local area network mol mole
Comission LAP left atrial pressure Monit monitoring (ECG filter)
Imped. impedance; impedance Lat. lateral MRI magnetic resonance imaging
respiration lb pound Mult. multiple
in inch LCD liquid crystal display Multif. PVCs
Inf. inferior LCW left cardiac work multifocal PVCs
Infl. inflation (limit) LED light emitting diode MV minute volume
insp inspiratory LVEDP left ventricular end diastolic MVexp expired minute volume (l/min)
Inv. invasive pressure MVexp(BTPS) expired minute volume in
InvBP invasive blood pressure LVEDV left ventricular end diastolic BTPS conditions
Irreg. irregular volume MVexp(STPD) expired minute volume in
LVSW left ventricular stroke work STPD conditions
LVSWI left ventricular stroke work MVinsp inspired minute volume (l/min)
index MVspont spontaneous minute volume
Myo myocardiac temperature
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TOF% ratio of the 4th to the 1st v venous WLAN wireless local area network
response (NMT) V ventricular VO2 oxygen consumption
Trigem. trigeminy V volume VO2calc calculated oxygen
TV tidal volume V/Q ventilation/perfusion ratio consumption*
TVexp expired tidal volume (ml) V0.5 volume expired during the first VO2I oxygen consumption index
TVinsp inspired tidal volume (ml) 0.5 seconds VO2Icalc calculated oxygen
Tx temperature label, x being 1, 2, V1.0 volume expired during the first consumption index*
3, r 4 or one of the other label second Vol volume
choices VA alveolar ventilation wt weight
Tymp tympanic temperature VC vital capacity X extreme
VCO2 carbon dioxide production yr year
V Fib ventricular fibrillation Vd dead space yrs years
V Run ventricular run Vd/Vt dead space ventilation
V Tachy ventricular tachycardia Vent. Calcs ventilation calculations * with Fick equation
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Performance
If the alarm mode is latched, the technical alarms Hemodynamic modules E-PSM,
WARNING: Operation of the monitor are latched as well. This does not comply with the
outside the specified values may NIBP (IEC 60601-2-30) and invasive pressure
E-PSMP
cause inaccurate results. (IEC 60601-2-34) standard requirements. 1)
Datex-Ohmeda S/5 FM Silencing alarms for 5 minutes does not comply with ECG
the SpO2 (ISO 9919) standard requirements. Filter modes:
Power supply Wireless Network Option, N-FMW monitoring filter 0.5 to 30 Hz
ST filter 0.05 to 30Hz
Rated voltages and Type: Built-in transceiver and
diagnostic filter 0.05 to 150 Hz
frequencies: 100 to 240V 50/60 Hz antenna
With 60 Hz power supply frequency:
Allowed voltage fluctuations: ±10% Frequency range:
monitoring filter 0.5 to 40 Hz
Max. power consumption: 150 VA Worldwide product covering 2.4 to 2.5 GHz, ST filter 0.05 to 40 Hz
Battery operation programmable for different country regulations
diagnostic filter 0.05 to 150 Hz
Batteries: Exchangeable lithium-ion, Data rate: 11 Mbps per channel (max.)
QRS minimum detection level:
2 pcs Output power: 100 mW
Minimum level 0.5 mV with duration between
Charging time: 3 hours per battery pack Data transmission: IEEE 802.11b compliant, Direct
40 and 120 ms fulfils ANSI/AAMI EC13 standard.
Operation time: Up to 5 hours Sequence Spread Spectrum
Defibrillation protection: 5000 V, 360 J
Environmental conditions (DSSS)
Recovery time: 5 seconds
Operating temperature: Security Wired Equivalent Privacy (WEP)
normal operation: +10 to +40°C (50 to 104°F) 40 and 128 bit encryption 1)
Certificates: Wi-Fi-certified The isolation barrier capacitance in the module
with CO2 measurement +10 to +40°C
has been minimized to reduce the hazard of burns in
(50 to 104°F)
the event of a defect in the ESU return electrode
while charging batteries: +10 to +35°C N-FREC, N-FCREC connection.
(50 to 95°F) Power consumption: 3 W
Storage and transport temperature: Recorder type: Thermal array
-20 to +60°C (-4 to 140°F) Print resolution:
Relative humidity: 10 to 90% noncondensing, Vertical 8 dots/mm (200 dots/inch)
in airway 0 to 100% Horizontal 32 dots/mm (800 dots/inch) at a
condensing speed of 25 mm/s and slower
Atmospheric pressure: 660 to 1060 mbar Paper width: 50 mm, printing width 48 mm
(500 to 800 mmHg) Traces: Selectable 1, 2, or 3 traces
Alarm behavior Print speed: 1, 6.25, 12.5, 25 mm/s
The maximum alarm delay of the alarm at the
monitor signal output to network: 1.1 seconds
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ECG (cont.) equipment typically cause false positive pacer Direct cardiac application:
detection. The display area reserved for the ECG measurement
Direct current for leads-off detection through an in the S/5 monitoring system screen may not be
Heart rate:
active patient electrode: <30 nA adequate for displaying the complete ECG
Measurement range: 30 to 250 bpm
Direct current for leads-off detection through a amplitude when measuring ECG direct from the
Measurement accuracy: ±5 % or ±5 bpm
reference electrode: <300 nA surface of the heart. Clipping of the signal can be
Display averaging time: 5 seconds
The normalized respiration sensing current between reduced by adjusting the size of the signal on the
Display update time: 5 seconds
RA (R) and LL (F) or RA (R) and LA (L) or LA (L) and display (for example, from the default 1.0 to 0.2) in
Average heart rate response time and time range of
LL (L): <5.0 µA the ECG menu.
response time (according to ANSI/AAMI EC13
Frequency of respiration sensing current: 31.25 kHz ECG analog output (X5):
4.1.2.1):
Minimizing the effects of the line isolation monitor Bandwidth of auxiliary output: 0.05 to 100Hz
Response time 80 to 120 bpm: 6.6 s (4.7 to 9.1 s)
transients: Gain: 1mV ECG signal is 1V ±10% at
Response time 80 to 40 bpm:
Crystal controlled oscillator used as the operating the analog output.
10.2 s (8.7 to 12.8 s)
frequency source of the patient isolation power Propagation delay: < 35ms.
Maximum Tall T wave amplitude that does not
supply.
disturb the heart rate calculation time (according to
The average time and time range ( ) to alarm for The pacemaker pulses have been replaced with 2ms
ANSI/AAMI EC13 4.1.2.1): 2.2 mV
tachycardia are as follows (ANSI/AAMI EC13 fixed digital pulses at the ECG output for IABP or
The heart rate calculation operates with irregular
4.1.2.1.g): defibrillator equipment.
rhythms of ANSI/AAMI EC13 4.1.2.1 as follows:
Figure 4a halved amplitude: 6.3 s (5.7 to 7.1 s) A device that fulfils the requirements of the IEC
a): 85 bpm
Figure 4a normal amplitude:6.1 s (5.0 to 8.6 s) 60601-1 standard can be connected to the ECG
b): 64 bpm
Figure 4a doubled amplitude:4.8 s (4.7 to 5.1 s) analog output. There are no other limitations,
c): 125 bpm
Figure 4b halved amplitude: 5.7 s (5.2 to 6.4 s) because the ECG analog output of the monitor is
d): 95 bpm
Figure 4b normal amplitude:6.6 s (5.1 to 8.7 s) galvanically isolated from patient applied part of the
Pacemaker pulse detection:
Figure 4b doubled amplitude:5.6 s (5.4 to 6.2 s) ECG measurement.
detection level: 2 to 700 mV
pulse duration: 0.5 to 2 ms The ECG measurement fulfils the requirements of the
The monitor is specified for both of the methods A ANSI/AAMI EC11 3.2.7.2 by using the test methods Impedance respiration
and B required in AANSI/AAMI EC13 section a, b, c and e. Respiration range: 4 to 120 resp/min
4.1.4.2. Accuracy: ± 5% or ± 5 resp/min
Offset voltage range: ±1.0 V The EMC immunity of the respiration measurement
CMRR: >95 dB has been tested with 1 Vrms and 1 V/m. This level
Pacer pulse rejection of fast ECG signals: has been used for optimizing the immunity of the
2.0 V/s according to the test defined in respiration measurement to damp the operating
ANSI/AAMI EC13 section 4.1.4.3. frequency of the electrosurgery equipment.
Pacemaker detector may not operate correctly
NOTE: Impedance respiration measurement is
during the use of high-frequency (HF) surgical
intended for patients over three years old.
equipment. The disturbances of HF surgical
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2) Wavelength of SpO2 probe LEDs:
Invasive blood pressure (E-PSMP)
Measurement range:-40 to 320 mmHg NIBP Infrared LED 940 nm
Measurement accuracy: ±5 % or ±2 mmHg 4) Red LED 660 nm
Blood pressure measurement range : Maximum energy of SpO2 probe LEDs:
Pulse rate:
adult 25 to 260 mmHg Infrared LED 42 µJ/pulse
Measurement range: 30 to 250 bpm
child 25 to 195 mmHg Red LED 62 µJ/pulse
Accuracy: ±5% or ±5 bpm
infant 15 to 145 mmHg
Transducer sensitivity: 5 µV/V/mmHg Pulse rate:
2) Pulse rate range accepted: 30 to 250 bpm
Temperature Measurement and display range: 30 to 250 bpm
Cuff pressure measurement range:
Measurement range: 10 to 45°C (50 to 113°F) Measurement accuracy: ±5% or ±5 bpm
-15 to + 350 mmHg.
Measurement accuracy: Typical measuring time: adult 23 s, infant 20 s 6)
Default alarm limits :
±0.1°C (25 to 45.0°C) Overall system accuracy: SpO2 high Off, low 90%
±0.2°C (10 to 24.9°C) Meets or exceeds SP10-2002 AAMI standards PR high 160, low 40
Measurement accuracy with single-use probes:
The ESU does not cause a burn hazard through the NOTE: For each SpO2 accessory, refer to the
±0.2°C (25 to 45°C)
NIBP cuff, because there is no electrical connection instructions for use in the accessory package for
±0.3°C (10 to 24.9°C)
between the cuff and the NIBP measuring patient weight limits.
Probe type: Use only Datex-Ohmeda temperature
electronics.
probes or defibrillator-proof YSI 400 series probes.
Temperature NOTE: NIBP measurement is intended for patients 2)
self-check: at start-up and then every weighing over 5 kg (11 lb). The isolation barrier capacitance in the module
10 minutes has been minimized to reduce the hazard of burns in
Time constant of temperature probes: 2) the event of a defect in the ESU return electrode
SpO2
Reusable skin temperature probe: 3s Measurement and connection.
Reusable adult central temperature probe: 6 s 3)
display range: 0 to 100% Response time of the probe exceeds 150 s.
Reusable pediatric central temperature probe: 4 s Calibration range: 70 to 100% 4)
Disposable skin temperature probe: 3 to 6s Cuff pressure measurement range is equal to cuff
Disposable central temperature probe, 12F: 5 to 8 s Calibrated against functional oxygen saturation. nominal and cuff indication ranges
5) 5)
Disposable central temperature probe, 9F: 5 to 8 s Measurement accuracy (% SpO2 ±1SD): Accuracy is based on deep hypoxia studies with
Esophageal stethoscope with temperature 100 to 70%, ±2 digits, volunteered subjects during motion and non-motion
probe, 9F: 15 s ±3 digits during clinical patient motion; conditions over a wide range of arterial blood oxygen
Esophageal stethoscope 69 to 0%, unspecified saturations as compared to arterial blood CO-
with temperature probe, 12F : 16 s Display update time: Oximetry.
Esophageal stethoscope 5 seconds continuous, defined by the main 6)
Limits are adjustable: OFF to 51% for SpO2 high
3) software of the monitor
with temperature probe, 18F : 23 s 50 to 100% for SpO2 low
Esophageal stethoscope Display resolution: 1 digit (1% of SpO2) 250 to 35 bpm for PR high
3) 30 to 245 bpm for PR low
with temperature probe, 24F : 32 s
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Airway gases, N-FCREC and N-FC Halothane (4%) increases < 0.3 vol% Respiration rate
Sampling rate: 150±25 ml/min (sampling line Isoflurane(5%) increases < 0.4 vol% Breath detection: 1% change in CO2 level
2 to 3 m, normal conditions) Enflurane(5%) increases < 0.4 vol% Measurement range: 4 to 80 breaths/min
Maximum sampling Desflurane(24%) increases < 1.2 vol% Accuracy: ±1 1/min in the range 4 to 20
Sevoflurane(6%) increases < 0.4 vol% 1/min
line length: 6m
Helium (50%) decreases < 0.3 vol% ±5% in the range 20 to 80 1/min
Sampling delay: 2.1 s typical with a 3-m
If O2 compensation is not activated: Resolution: 1/min
sampling line
O2 (40 to 95%) decreases < 0.3 vol%
Total system response time: 2.4 seconds typical If O2 compensation is activated: NOTE: CO2 measurement is intended for patients
with a 3-m sampling line, O2 (40 to 95%) error < 0.15 vol% weighing over 5 kg (11 lb).
including sampling delay and If N2O compensation is not activated:
rise time (typically 3.7 seconds N2O (40%) decreases < 0.4 vol% 7)
with a 6-m sampling line) If N2O compensation is activated: Alarm limits and their adjustment range may vary
Warm-up time: 1 min for operation N2O (40 to 80%) error < 0.3 vol% depending on the mode used.
30 min for full specification 7)
Autozeroing interval: 4, 15, 30 and 60 minutes after Default alarm limits :
start-up, then every 60 minutes EtCO2 high 8%, low 3%
Non-disturbing gases are those with a maximum FiCO2 high 3%, low Off
effect on the CO2 reading at 5.0 vol% < 0.2 vol%.
The effect is valid for specific concentrations shown Carbon dioxide (CO2)
in parentheses of the non-disturbing gas: Measurement range: 0 to 20 vol%
Ethanol C2H5OH (<0.3%) Resolution: 0.01%
Acetone (<0.1%) Measurement rise time: < 300 ms with nominal flow
Methane CH4(<0.2%) Accuracy:
Nitrogen N2 (0 to 100%) 0 to 15 vol% ± (0.2 vol% + 2% of reading)
water vapor (0 to 100%) 15 to 20 vol% ± (0.7 vol% + 2% of reading)
Trichloromonofluoromethane (<1%) Valid for respiration rate < 40 1/min at I:E ratio of
Dichlorotetrafluoroethane (<1%) 1:1. (Relative error is typically 10% for respiration
Dichlorofluoromethane (<1%) rate 80 1/min at I:E ratio of 1:1.) The accuracy is
specified in simulated ventilation. With higher
Disturbing gases and their effect on the CO2 reading respiration rates and with varying ventilation
at 5.0 vol% CO2 are shown below. Errors listed methods the specifications may not be met.
reflect the effect of specific concentrations (shown in
parentheses) of an individual disturbing gas and
should be combined when estimating the effect of
gas mixtures:
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Warranty
This Product is sold by Datex-Ohmeda under the warranty set forth in Datex-Ohmeda’s sole and exclusive obligation and Buyer’s sole and
the following paragraphs. Such warranty is extended only with respect exclusive remedy under the above warranty is limited to repairing or
to the purchase of this Product directly from Datex-Ohmeda or Datex- replacing, free of charge, at Datex-Ohmeda’s option, a Product, which
Ohmeda’s Authorized Dealers as new merchandise and is extended to is telephonically reported to the nearest Datex-Ohmeda office or
the Buyer thereof, other than for the purpose of resale. Datex-Ohmeda’s Authorized Dealers office and which, if so advised by
Datex-Ohmeda, is thereafter returned with a statement of observed
For a period of twelve (12) months from the date of original delivery to deficiency, not later than seven (7) days after the expiration date of
Buyer, this Product, other than expandable parts, is warranted the applicable warranty, to the Datex-Ohmeda office or Datex-
against functional defects in materials and workmanship and to Ohmeda’s Authorized Dealers office during normal business hours,
conform to the description of the Product contained in this manual transportation charges prepaid, and which, upon Datex-Ohmeda’s
and accompanying labels and/or inserts, provided that the same is examination, is found not to conform to the above warranty. Datex-
properly operated under the conditions of normal use, that regular Ohmeda shall not be otherwise liable for any damages including but
periodic maintenance and service is performed and that the not limited to incidental damages, consequential damages, or
replacements and repairs are made in accordance with the special damages.
instructions provided, using genuine parts and performed by a trained
person. The foregoing warranty shall not apply if the Product has been There are no express or implied warranties, which extend beyond the
repaired by anyone other than Datex-Ohmeda or otherwise than in warranty hereinabove set forth. Datex-Ohmeda makes no warranty of
accordance with written instructions provided by Datex-Ohmeda, or merchantability or fitness for particular purpose with respect to the
altered by anyone other than Datex-Ohmeda, or if the Product has product or parts thereof.
been subject to abuse, misuse, negligence, or accident.
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