Zoll 9650-0212-01 Rev-F GLIDERITE DLT STYLET Operations & Maintenance Manual

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End-Tidal Carbon Dioxide (EtCO )
2
9650-0212-01 Rev. F
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This issue date or revision level for this operation guide is shown on the front cover. ZOLL and M Series are trademarks of ZOLL Medical Corporation.
© 2002 by ZOLL Medical Corporation. All rights reserved
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END-TIDAL CARBON DIOXIDE (EtCO2)

General Information

Product Description
The M Series End-Tidal Carbon Dioxide (EtCO2) option continuously measures carbon dioxide and respiratory rate using a unique mainstream, solid-state infrared sensor called a Capnostat
*. The Capnostat
sensor is attached to an airway adapter that connects t o an endotracheal tube, similar airway, or disposable mouthpiece. Infrared light is generated by the sensor and beamed through the airway adapter to a detector on the opposite s ide of the airway. CO
(carbon dioxide),
2
flowing through the airway adapter as a result of respiration, absorbs some of this infrared energy. The monitor determines
concentration in the breathing gases by measuring the amount of light absorbed by gases flowing through the airway.
CO
2
End-Tidal Carbon Dioxide (Et CO
) is displayed as a numerical value in millimeters of mercury (mmHg), perc ent (%), or
2
kilopascals (kPa). In addition, a capnogram waveform may be displayed. This waveform is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube (ET) placement.
Respiration rate is calculated by measuring the time interval between detected peaks of the EtCO
capnogram waveform.
2
The technology differentiates between waveforms caused by breathing and those caused by cardiogenic oscillations and artifact.
How to Use This Manual
This section explains how to set up and use the M Series End-Tidal Carbon Dioxide option. Important safety information relating to general use of the M Series End-Tidal Carbon Dioxide monitor appears in the “Safety Considerations” section of this manual.
The M Series Operator's Guide provides information operators need for the safe and effective use and care of the
M Series products. It is important that persons using this device read and understand all the information contained within. Please thoroughly read both safety considerations and warnings sections before operating your
M Series product.
EtCO2 Accessories
Capnostat
Sensor Cable Holding Clips, bag of 5
SPU Pediatric/Adult Airway Adapter: Single patient use adapter for ET tube sizes > 4.0mm
SPU Neonatal/Pediatric Airway Adapter : Single patient use adapter for ET tube sizes <= 4.0mm
Reusable Adult Airway Adapter: Reusable adapter for ET tube sizes > 4.0mm
Reusable Neonatal Airway Adapter: Reusable adapter for ET tube sizes <= 4.0mm
SPU Pediatric/Adult Airway Adapter with Mouthpiece: Single patient use adapter and mouthpiece for
Capno
Capno
Capno
* Capnostat
EtCO2 - 1
non-intubated patients
Mask Pediatric
2
Mask Standard Adult
2
Mask Large Adult
2
is a registered trademark of the Novametrix Corporation.
CO2 Sensor and Cable
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OPTION INSERT

SAFETY CONSIDERATIONS

Warnings
General
Before use, carefully read the M Series Operator’s
The M Series EtCO
The M Series EtCO
Do not immer se the M Series device, patient
If an alarm condi tion occurs while the alarms are
To ensure patient safety, the ECG-out jack and
Elevated oxygen levels, nitrous oxide or
As with all medical equipment, carefully route
Guide and these operating instructions.
option is to be operated by
qualified personnel only.
an apnea monitor.
cables, sensors or airway adapters in water, solvents, or cleaning solutions.
I
f the accuracy of any reading is suspect, first check the patient's vital signs by alternate means and then check the M Series EtCO operation.
suspended, the suspended alarm indications will only be visual displays and symbols.
modem (if available) should only be connected to other equipment with galvanically isolated circuits.
halogenated agents contained in the breathing gases may degrade the accuracy of measurements made with the M Series EtCO compensation should be turned on if O excess of 60% are introduced. N should be used if nitrous oxide is introduced into the airway circuit. The presence of Desflurane beyond 5% may positively bias the carbon dioxide reading by up to 3mmHg.
patient cabling to reduce the possibility of patient entanglement or strangulat ion.
2
option should NOT be used as
2
option for proper
2
option. Oxygen
2
levels in
2
O compensation
2
Sensor and Airway Adapters
Use only ZOLL / Novametrix Capnostat
sensor and
airway adapters.
The disposable Airway Adapters and disposable airway adapter with mouthpiece are intended for single patient use. Do NOT reuse or sterilize these disposable adapters, as system performance will be compromised.
Inspect the sensor and airway adapter connections to ensure correct positioning.
Do not use a damaged sensor or airway adapter.
Do not sterilize or immerse the sensor.
Do not place adult airway adapters between the ET
tube and the breathing circuit elbow as this may allow patient secretions to block the adapter windows.
Position airway adapters with windows in a vertical, NOT a horizontal, position. This helps keep patient secretions from “pooling” on the windows.
To prevent moisture from draining into the airway adapter, do NOT place the adapter in a gravity dependent position.
Always ensure the integrity of the patient breathing circuit after insertion of the airway adapter by verifying a proper CO
waveform (capnogram) on the monitor
2
display.
Do not apply tension to the sensor cable.
Do not store sensors at temperatures less than
-10° C or greater than 55°C.
Do not operate sensors at temperatures less than
10° C or greater than 40°C.
Do not touch the bed, patient, or any equipment
connected to the patient during defibrillation. A severe shock can result. Do not allow exposed portions of the patient’s body to come in contact with metal objects, such as a bed frame, as unwanted pathways for defibrillation current may result.
All sensor an d airway adapter questions with r egards to the Declaration of Conformity with European Union Directives should be directed to the authorized representative for Novametrix:
Novametrix CE Contact
European Compliance Services, Ltd.
Oakdene House, Oak Road
Watchfield, Swindon Wilts
SN6 8T D, UK
EtCO2 - 2
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End Tidal CO
2
Warranty (U.S. Only)
(a) ZOLL Medical Corporation warrants to the original equipment purchaser that beginning on the date of installation, or thirty (30) days after the date of shipment from ZOLL Medical Corporation's facility, whichever first occurs, the equipment (other than accessories and electrodes) will be free from defects in material and workmanship under normal use and service for the period of one (1) year and two (2) years for Capnostat During such period ZOLL Medical Corporation will, at no charge to the customer, either repair or replace (at ZOLL Medical Corporation's sole option) any part of the equipment found by ZOLL Medical Corporation to be defective in material or workmanship. If ZOLL Medical Corporation's inspection detects no defects in material or workmanship, ZOLL Medical Corporation's regular service charges shall apply. (b) ZOLL Medical Corporation shall not be responsible for any equipment defect, the failure of the equipment to perform any function, or any other nonconformance of the equipment, caused by or attributable to: (i) any modification of the equipment by the customer, unless such modification is made with the prior written approval of ZOLL Medical Corporation; (ii) the use of the equipment with any associated or complementary equipment, (iii) installation or wiring of the equipment other than in accordance with ZOLL Medical Corporation's instructions. (c) This warranty does not cover items subject to normal wear and burnout during use, including but not limited to lamps, fuses, batteries, pat ient cables and accessories. (d) The foregoing warranty constitutes the exclusive remedy of the customer and the exclusive liability of ZOLL Medical Corporation for any breach of any warranty related to the equipment supplied hereunder. (e) Limita tion of Liability: ZOLL shall not in any event be liable to Purchaser, nor shall Purchaser recover, for special, incidental or consequential damages resulting from any breach of warranty, fai lure of essential purpose, or under any other legal theory including but not limited to lost profits, lost savings, downtim e, goodwill, damage to or replacement of equipment and property, even if ZOLL has been advised of the pos sibility of such damages.
sensors.
Software License
Read this Operator's Manual and License agreement carefully before operating any of the M Series products.
Software incorporated into the system is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties. This software is licensed, not sold. By taking delivery of and using this system, the Purchaser signifies agreem ent t o and acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the
software license fee which is part of the price paid for this product ZOLL Medical Corporation grants the Purchaser a non-exclusive license, without right to sublicense, to use the system software in object-code form only.
Ownership of Software/Firmware: Title to, ownership
2.
of and all rights and interests in the system software and all copies thereof remain at all times vested in the manufacturer, and Licensors to ZOLL Medical Corporation and they do not pass to Purchaser.
3. Assignment: Purchaser agrees not to assign, sub-
license or otherwise transfer or share its rights under the license without the express written permission of ZOLL Medical Corporation.
4. Use Restrictions: As the Purchaser, you may
physically transfer the products from one location to another provided that the software/firmware is not copied. You may not disclose, publish, translate, release or distribute copies of the software/firmware to others. You may not modify, adapt , translate, reverse engineer, decompile, crosscompile, disassemble or create derivative works based on the software/firmware.
THE WARRANTY SET FORTH HEREIN IS EXCLUSIVE AND ZOLL MEDICAL CORPORATION EXPRESSLY DISCLAIM S ALL OTHER WARRANTIES WHETHER WRITTEN, ORAL, IMPLIED, OR STATUTORY, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
For additional information, please call ZOLL Medical Corporation at 1-800-348-9011 (in Massachusetts: 1-781-229-0020). I nt er nat ional customers should call the nearest authorized ZOLL Medical Corporation service center.
9650-0212-01 EtCO2 - 3
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OPTION INSERT
EtCO
Indications for Use
2
The ZOLL M Series EtCO2 option with Novametrix technology and Capnostat continuous noninvasive monitoring of end tidal carbon dioxide (EtCO
) and respiration rate in patients requiring
2
ventilator support, t r anspor t , and anesthesia . The M Series EtCO
option is designed to monitor adult, pediatric,
2
and neonatal patients. The following substances can influence CO
made with the Capnostat nitrous oxide, and halogenated agents. The M Series EtCO
option allows the user to enable high oxygen and/or
2
nitrous oxide compensation. Halogenated anesthetic agents alter CO
readings but the M Series will monitor CO2 within
2
specifications when these agents are present at normal clinical levels. The presence of desflurane in the exhaled breath beyond normal values (5-6%) may positively bias measured Carbon Dioxide values by up to an additional 2-3 mmHg.
sensor is indicated for the
measurements
Sensor: elevated oxygen levels,
2
The sensor zero will be performed automatically and a “ZEROING CO2 SENSOR” message will be displayed typically for 15 seconds.
The M Series retains the sensor’s zero calibration settings during and after its use. When a previously used sensor is reconnected to the M Series, sensor zeroing does not need to be repeated.
The sensor’s calibration can be checked by placing the sensor on the “REF” cell for 5 or more seconds (see Figure
2).
The M Series EtCO the ZOLL / Novametrix Capnostat
option is intended for use only with
2
sensor and airway
adapters.

EtCo2 Setup

The numeri c EtCO2 value is displayed in units of mmHg unless configured for percent or kPa. Refer to the M Series Configuration Guide (Part No. 9650- 0201- 01) for instructions on how to configure alternate units of measure.
Attach the Capnostat sensor cable to the CO2 connector at the rear of the M Series product.
Turn the selector switch to MONITOR or ON. Wait for the CO
sensor to warm up. The message
2
“WARM UP” is displayed in the CO2 data field typically for less than one minute while the sensor warms to operating temperature. The message disappears when the sensor is ready for use.
CapnostatSENSOR ZERO
The first time a particular Capnostat sensor is connected to the monitor a “ZERO CO2 SENSOR” message will be displayed. Place the Capnostat located on the sensor cable (see Figure 1).
sensor on the “0” cell
Figure 2
An EtCO
value of 38mmHg +/- 2 mmHg should be
2
displayed.
Warning
Removing the capnostat sensor from the “REF” cell before the 5 second calibration check period has elapsed will result in a need to rezero the sensor and the airway adaptor.
Attach the airway adapter to the Capnostat sensor and perform an Airway Adapter zero if necessary.
Airway Adapter Zero
Adapter zeroing is required after switching between different airway adapter types.
Press the “Param.“ softkey, select the “EtCO2” menu item, and then press “Enter”.
Press the “Zero” softkey. Place the sensor with the adapter installed away from all
sources of CO exhaled breath and ventilator ex haust valves).
(including the patient’s -- and your own --
2
Select “Start” using the “Zero” softkey, then press “Enter”.
“ZEROING CO2 ADAPTER” is displayed. The Airway Adapter zeroing process is typically finished within 15 seconds.
Figure 1
EtCO2 - 4
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End Tidal CO
2

SELECTING AN AIRWAY ADAPTER

Select an airway adapter based on the patient’s size, ET tube diameter and monitoring situation. For more information refer to the following table or contact ZOLL Medical Corporation.
Airway Adapter Endotracheal Tube Diameter SPU Pediatric/Adult >4.0mm
Adult Reusable >4.0mm SPU Neonatal/Pediatric <=4.0mm Neonatal Reusable <=4.0mm

DIRECTIONS FOR USE OF THE REUSABLE ADULT AND NEONATAL AIRWAY ADAPTERS

Reusable Adult Airway adapters should be used when monitoring intubated patients with Endotracheal Tube diameters greater than 4.0mm. Reusable Neonatal Airway Adapters should be used when monitoring intubated patients with Endotracheal Tube diameters less than or equal to 4.0mm. Alternatively, disposable airway adapters may be used.
1. Verify that the airway adapter windows are clean and dry. Clean or replace the adapter if necessary.
2. Snap the airway adapter into the Capnostat Align the arrow on the bottom of the airway adapter with the arrow on the bottom of the Capnostat the sensor and airway adapter together until they "click”.
3. Perform an airway adapter zero (as described below) if switching between different airway adapter types. Press the “Param.“ softkey and select the EtCO2 menu item then press “Enter”. Place the sensor with the adapter installed away from all sources of CO (including the patient’s -- and your own -- exhaled breath and ventilator exhaust valves). Press the “Zero” softkey until the “Start” menu item is highlighted, then press “Enter”. “ZEROING CO2 ADAPTER” will be displayed for approximately 15 seconds.
4. When using the Adult Airway Adapter, place the Capnostat
/Airway Adapter assembly at the proximal end of the airway circuit between the elbow and the ventilator circuit wye. Do not place the airway adapter between the ET tube and the elbow as this may allow patient secretions to block the adapter windows. Position the airway adapter with its windows in a vertical, NOT a horizontal, position. This helps keep patient s e c retions f rom “pool i ng ” on the windows . If pooling does occur, the airway adapter may be removed from the circuit, rinsed with water and reinserted into the circuit. To prevent moistu re from draining into the airway adapter, do NOT place the
sensor.
. Press
2
airway adapter in a gravity dependent position. See Figure 3.
Reusable
Figure 3
5. Check that connections have been made correctly by verifying the presence of a proper CO
waveform on
2
the M Series display.
6. The sensor cable should face away from the patient. To secure the sensor cable safely out of the way, attach S ensor Cable Holding Clips to the a irway tubing, then connect the sensor cable to the clips.

DIRECTIONS FOR USE OF THE SINGLE PATIENT USE PEDIATRIC/ADULT AIRWAY ADAPTER AND THE NEONATAL/PEDIATRIC AIRWAY ADAPTER

Disposable Pediatric/Adult Airway adapters should be used when monitoring intubated patients with Endotracheal Tube diameters greater than 4.0mm. Disposable Neonatal/Pediatric Airway Adapters should be used when monitoring intubated patients with Endotracheal Tube diameters less than or equal to 4.0mm. Alternatively, reusable airway adapters may be used.
Caution: The disposable Pediatric/Adult Airway Adapter is intended for single patient use. Do NOT reuse or sterilize the adapter as system performance will be compromised.
1. Remove adapter from the package. Verify the adapter is intact.
2. Snap the airway adapter into the Capnostat Align the arrow on the bottom of the airway adapter with the arrow on the bottom of the Capnostat the sensor and airway adapter together until they "click”.
sensor.
. Press
9650-0212-01 EtCO2 - 5
Page 8
OPTION INSERT
3. Perform an airway adapter zero (as described below) if switching between different airway adapter types. Press the “Param.“ softkey and select the EtCO2 item then press “Enter”. Place the sensor with the adapter installed away from all sources of CO
(including the
2
patient’s -- and your own -- exhaled breath and ventilator exhaust valves). Press the “Zero” softkey until the “Start” menu item is highlighted, then press “Enter”. “ZEROING CO2 ADAPTER” will be displayed for approximately 15 seconds.
4. When using the Neonatal/Pediatric Airway Adapter, place the Capnostat
/Airway Adapter assembly at the proximal end of the airway circuit between the endotracheal tube and the ventilator circuit wye. Position the airway adapter with its windows in a vertical, NOT a horizontal, position. This helps keep patient secretions from “pooling” on the windows. If pooling does occur, the airway adapter may be removed from the circuit, rinsed with water and reinserted into the circuit. To prevent moistu re from draining into the airway adapter, do NOT place the airway adapter in a gravity dependent position (see Figure 4).
1. Remove adapter with mouthpiece from the package. Verify that the adapter and mouthpiece are intact and securely fastened to each other.
2. Snap the airway adapter into the Capnostat Align the arrow on the bottom of the airway adapter with the arrow on the bottom of the Capnostat
sensor.
. Press the sensor and airway adapter together until they "click”.
Perform an airway adapter zero (as described below) if
3.
switching between different airway adapter types. Press the “Param.“ softkey; select the EtCO2 menu item then press “Enter”. Press the “ Zero” softkey. Place the sensor with the adapter installed away from all sources of CO
(including the patient’s -- and your
2
own -- exhaled breath and ventilator exhaust valves). Press the “Zero” softkey until the “Start” menu it em is selected then press the “Enter” softkey. “ZEROING CO2 ADAPTER” is displayed and is finished typically within 15 seconds.
Patient should seal his or her mouth completely around
4.
the mouthpiece and breathe normally (see Figure 5).
Figure 5
Sensor
2
.
.
Figure 4
5. Check that connections have been made correctly by verifying the presence of a proper CO
waveform on
2
the M Series display.
6. The sensor cable should face away from the patient. To secure the sensor cable safely out of the way, attach S ensor Cable Holding Clips to the a irway tubing, then connect the sensor cable to the clips.
DIRECTIONS FOR USE OF THE SINGLE PATIENT USE PEDIATRIC/ADULT AIRWAY ADAPTER WITH MOUTHPIECE
The disposable Pediatric/Adult airway adapter with mouthpiece can be used for spot checking CO intubated adult or pediatric patients.
Caution: The disposable Pediatric/Adult Airway Adapter with mouthpiece is intended for single patient use. Do NOT reuse or sterilize the adapter, as system performance will
on non-
2

CLEANING SENSOR AND AIRWAY ADAPTERS

Cleaning the Capnostat CO
1. Clean the sensor surfaces with a damp cloth.
2.
Ensure the sensor windows are clean and dry.
3. Do not immerse the Capnostat
4. Do not attempt to sterilize the Capnostat
Cleaning the Reusable Airway Adapters
1. The reusable Adult and Neonatal Airway Adapters may be cleaned by rinsing in a warm soapy solution, followed by soaking in a liquid disinfectant (refer to the disinfectant manufacturer 's instructions for use). It should then be rinsed with sterile water and dried.
2. Before reusing the adapter, ensure the windows are dry and residue-free, and that the adapter has not been damaged during handling or by the cleaning process.
be compromised.
EtCO2 - 6
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End Tidal CO
2
How EtCO
is Displayed
2
The M Series End-Tidal CO2 option monitors both CO2 and respiration rate. The results of this monitoring are displayed in the “CO2” field loca ted in the upper lef t side of the M Series display. The M Series EtCO
option displays the
2
maximum concentration of carbon dioxide detected during each breath. This maximum CO
concentration usually
2
occurs at the end of expiration, thus the term “End Tidal CO
” or EtCO2. The numeric EtCO2 value is displayed as
2
“CO2 mmHg” if the units mmHg has been configured. Alternately the units of percent or kPa may be configured. Refer to the M Series Configuration Guide (Part No. 9650­0201-01) for instruct ions on how to configure alternate units of measure. The number of breaths per minute is displayed and labeled “RR” for respiration rate. In addition, a capnogram waveform may be selected using the “Wave2” softkey.

PHYSIOL OGICAL MONITORING

The physiological monitoring menu includes the following softkeys: “Param”, “Wave2”, “ID#, “Alarms,” and “12 Lead.”
Param” Softkey
When the “Param” softkey is pressed the following softkeys will be displayed : “Select”, “Enter”, and “Return”.
Adapter zeroing may also be necessary if the monitor displays “ZERO CO
ADAPTER?”.
2
Pressing the “Zero” softkey causes the start/cancel menu to appear. Pressing the “Zero” softkey again toggles the highlight between “Start” and “Cancel”.
Pressing the “Enter” softkey with Start highlighted initiates zeroing of the adapter. The message “ZEROING CO2 ADAPTER” will be displayed during the zeroing process, which is typically finished in 15 seconds.
The “Cancel” selection halts the adapter zeroing process. Pressing “Enter” allows the user to enter the highlighted selection. Pressing “Return” will return the user to the EtCO
submenu.
2
“Average” Softkey
The M Series provides three (3) different time periods over which the highest EtCO
values are averaged: 1 breath, 10
2
seconds (default) and 20 seconds. The user can select the averaging period by pressing the
Average” softkey. When the “Average” softkey is pressed the following softkeys will be displayed: “Average”, “Enter”, and “Return”.
Pressing the “Average” s o ftkey will scroll the highlighted area among the different averaging periods of 1 breath, 10
Pressing the “Select” softkey will scroll the highlighted area among the different available physiological monitoring functions. Pressing the “Enter” softkey allows the user to select the function that is highlighted. Pressing the “Return” softkey allows the user to return to the physiological monitoring menu.
Selecting the EtCO
parameter causes the following
2
softkeys to appear: “Zero”, “Average”, “Comp.”, “Zoom”, and “Return”. Note that the Zoom softkey is only displayed if the capnograph waveform is also displayed.
seconds and 20 seconds. Pressing the “Enter” softkey allows the user to select the
highlighted averaging period. Pressing the “Return” softkey returns the user to the EtCO
submenu. Pressing the
2
Return” softkey again will return the user to the physiological monitoring menu.
“Comp” Softkey
The M Series provides the ability to compensate for elevated levels of oxygen and/or the presence of nitrous oxide. Oxygen compensation should be activated when oxygen levels in excess of 60% are present in the airway circuit. Nitrous oxide compensation should be activated when nitrous oxide is present in the airw ay circuit.
“Zero” Softkey
Adapter zeroing compensates for the op tical differences between airway adapters and should be performed whenever the Airway adapter type has been changed.
If the concentration of oxygen in the breathing circuit exceeds 60% and nitrous oxide is in use, both O
2
should be activated. When the “Comp” softkey is pressed, the following softkeys
will be displayed : “Comp.”, “Enter”, and “ Return”.
9650-0212-01 EtCO2 - 7
and N2O
Page 10
OPTION INSERT
3 seconds after Sync mode is turned off
The Capnogram waveform is displayed at half t he speed of the ECG display, and provides 8 seconds of data.
Use the “Zoom” softkey from t he EtCO the waveform display size. Numbers shown on the left side of the Capnogram display indicate the scaling.
Pressing the Comp. softkey will scroll the highlight among the different types of compensation available (either NONE, O2, N2O, or O2 & N2O). The “O2&N2O” selection turns oxygen and nitrous oxide compensation on. Two asterisks (*), located on the left side of the CO2 field, will be displayed indicating compensation for both oxygen and nitrous oxide. The left asterisk indicates oxygen compensation is active and the right asterisk indicates nitrous oxide compensation is active. The “O2” selection turns oxygen compensation on and displays an asterisk in the far left of the CO2 field. The “N2O” selection turns nitrous oxide compensation on and displays an asterisk to
CO2
ECG
50
0
Param.
20
CO2
SpO2 %
m mHg
Wave 2
98
the right of the O2 asterisk. The “NONE” selection will turn all compensations off and eliminate the asterisks from the display. After selecting the appropriate compensation press “Enter” to activate the selected function.
Pressing the “Return” softkey will return the user to the EtCO
submenu. Pressing the “Return” sof tkey again will
2
return the user to the physiological monitoring menu.
“Zoom” Softkey
The user can select the zoom level for capnogram waveforms by pressing the “Zoom” soft key. W hen the “Zoom” softkey is pressed the scale for the displayed cagnogram waveform will scroll among 0-12.5 mmHg, 0-25 mmHg, 0-50 mmHg, 0-75 mmHg, and 0-100 mmHg.
The scales are 0-1.7, 0-3.3, 0-6.6, 0-10, and 0- 13. 3 if units of kPa or % have been configured. (Refer to the M Series Configuration Guide for instructions on how to configure alternate units of measure.)
Displaying the Capnogram “Waveform”
M Series systems allow the user to disp lay one or two
waveforms when in the Monitor, Defib, or Manual (AED) mode. Only one waveform will be displayed in Pacer mode.
Pressing the “Wave2” softkey from the physiological monitoring menu cycles the display from the capnogram waveform, to the plethysmograph waveform (if SpO2 is installed), to no second waveform displayed.
A second waveform can be displayed provided that the defibrillator is not charging or an ECG analysis is not in progress. The waveform will be temporarily removed from the display, if currently visible, when any of the following buttons is pressed: Charge, Analyze, Energy Select, Sync On/Off. The second waveform will be restored to the display under the following conditions:
3 seconds after a shock is delivered
3 seconds after an analysis is completed, unless the
defibrillator is charging
4 seconds after the last Energy Select button press
Recorder Operation
To start the strip chart recorder, press the RECORDER button. The recorder will run continuously until the button is pressed again.
Each time the strip chart recorder is started, the time, date, ECG lead, size, heart rate, r espirat ion rate, and EtCO value are printed on the top part of the paper. If selected, the Capnogram wavef o rm will also be printed with the selected scaling under the ECG trace.
All waveforms printed by the recorder are delayed by six seconds relative to their occurrence.

Alarms

The M Series EtCO2 option provides user programmable “out of range” alarms for both End-Tidal CO Respiration Rate. Press the “Alarms” softkey to display the Alarm Set screen and softkeys.
The EtCO State field and cannot be enabled or disabled separately. Enabling the EtCO respira tion rate alarm functio n s. Disabling EtCO respiration rate alarms disables the other alarm function.
Press the Inc or Dec softkeys to select "ENABLE", "DISABLE", or "AUTO" for both t he Et CO respiration rate alarm. Pressing the Next Field softkey when either “ENABLE or “DISABLE” has been chosen will set the selected State for EtCO move the highlight to the next field (Low limit field).
When "AUTO" has been selected for EtCO rate and the Next Field softkey is pressed, the unit will automatic ally set the lower and upper limits for EtCO respiration rate. For EtCO of the patient’s currently measured EtCO
and respiration rate alarms share the same
2
EtCO2 - 8
ECG
PADS
RR
9
ID#
alarms enables both EtCO2 and
2
12 Lead
Alarms
and respiration rate and
2
, the limits will be set to +/- 25%
2
submenu to adjust
2
HR LEAD
SIZE
70
X3
2
alarm and the
2
and respiration
2
value. If the
2
and
2
or
2
and
2
Page 11
End Tidal CO
2
EtCO2 value is greater than 40mmHg (which is equivalent to
5.3kPa or 5.3% at a barometric pressure of 760mmHg), then 10mmHg (1.3 for kPa or %) will be added and subtracted from the reading to set the upper and lower limits. The auto alarm limits are set only if valid measurements are present for the vital sign.
For the automatic respiration rate alarm limits, the unit will set the lower and upper limits for respiration by adding and subtracting the values shown in the following table from the patient’s current breath rate.
Respiration Limits
Respiration Rate
Average
1-15 breaths/min. +7 breaths/min. -50% of value
16-40 breaths/min +10 breaths/min. -7 breaths/min.
>40 breaths/min +15 breaths/min -10 breaths/min.
Refer to the ALARMS Section of the M Series Operator’s Guide for further det ails.
The M Series device has three levels of alarms.
1. High Priority: If enabled, t hese alarms reflect physiological parameters that are outside the previously set limits. They will cause a continuous audio tone, highlight the alarming parameter and flash the associated alarm bell.
2. Medium Priority: These alerts reflect equipment related user correctable faults such as “LEAD OFF” or “ZERO CO2 ADAPTER?”. They will cause a 2 beep audio tone and display a message for a timed period.
3. Low Priority: These are informational messages to the user, such as WARMUP, and will have no audio indication.
High Limit Low Limit
Alarm Limits
The following table shows the low and high alarm limit ranges for EtCO
mmHg % kPa
Low Alarm Limit
Range
Low Alarm Limit
Default
High Alarm
Limit Range
High Alarm
Limit Default
The Low respiration rate Alarm Limit range is 0 to 100 respirations per minute with default setting of 5. The High
and default values.
2
EtCO2 Alarm Limit Ranges
0 to 95 0 to 12.5 0 to 12.6
25 3.2 3.3
5 to 100 0.6 to
13.1
55 7.2 7.3
0.6 to 13.3
respiration rate Alarm Limit range is 5 to 150 respirations per minute with a default setting of 120.
Suspending Alarms
A high priority alarm notifies users in the following ways:
continuous audio tone sounds
value of the alarming paramete r on display highlights
bell on display associated with parameter flashes
15-second strip chart recording prints (if configured)
Press the ALARM SUSPEND button to silence the alarm tones for approximately 90 seconds. An “X” will be placed through the flashing bell ( associated with the affected parameter have been temporarily disabled. Pressing the ALARM SUSPEND button again will reactivate the alarm processing.
When the alarm suspend period has timed-out and the alarm condition has not been corrected, the following will occur:
a continuous audio tone will return
the value of the alarming parameter will continue to be
highlighted
the bell associated with that parameter will flash. When the alarm suspend period has timed-out and the
violation has been corrected the M Series will return to normal operating mode.
If a second alarm relating to a different parameter occurs while the first alarm is suspended, press the ALARM SUSPEND button to suspend the second alarm tone. The old alarm continues a separate time out of its suspension.
Activating / Deactivating Alarms
Pressing and holding the ALARM SUSPEND button for approximately 4 seconds will deactivate all alarm functions. All bells will have an “ X” through them ( alarms are deactivated.
If all alarms are deactivated and the ALARM SUSPEND button is briefly pressed, all of the enabled alarm functions will be activated. (Refer to SET ALARMS Section of the M Series Operator’s Guide).
to indicate that alarms
)
to indicate that
)
9650-0212-01 EtCO2 - 9
Page 12
OPTION INSERT

Automated External Defibrillator (AED) Operation

M-Series AED’s equipped with End Tidal Carbon Dioxide operate in a slightly different way than Manual and Advisory models equipped with EtCO explained below.
Semi-Automatic Operation
The capnogram waveform cannot be displayed in Semi­Automatic mode.
Although EtCO2 alarm functions are operational in semi­automatic mode, Heart Rate alar m functions are disabl ed. Background ECG analysis functions, however, continue to operate as described in the AED section of the M Series Operator’s Guide.
The EtCO pressing the “Param” softkey.
The ALARM SUSPEND button can be used to activate, deactivate, or suspend the EtCO previously. The alarm limit settings cannot, however, be changed in semi-automatic mode. Only the default alarm limits are available. See the M Series Configuration Guide for information on setti ng alarm limit de faults.
Manual Mode Operati on
The capnogram waveform can be displayed by pressing the “Wave2” the softkey provided that the defibrillator is not charging or an ECG analysis is not in progress. The waveform will be temporarily removed from the display, if currently visible, when any of the following buttons are pressed: CHARGE, ANALYZE, ENERGY SELECT, SYNC ON/OFF. The second waveform will be restored to the display under the following conditions:
3 seconds after a shock is delivered
3 seconds after an analysis is completed, unless the
defibrillator is charging
4 seconds after the last Energy Select button press
3 seconds after Sync mode is turned off
The waveform cannot be displayed in pace mode. Both Heart Rate and EtCO
alarm limits can be changed by pressing the “Alarms” softkey. The EtCO by pressing the “Param” softkey.
. These differences are
2
monitoring parameters can be changed by
2
alarms as described
2
alarms are operational. The
2
monitoring parameters can be changed
2
Check Out Procedure
The following procedure verifies that the sensor has been zeroed correctly, and that the alarms are functional:
1. Attach the Capnostat M Series product.
2. Turn the selector switch to MONITOR mode or ON (for AED models select “M anual Mode”).
3. Connect sensor to “0” cell, which is located on the Capnostat sensor cable.
4. Wait for the CO required). The message “WARM UP” is displayed typically for less than one minute. If sensor zero is required, the message “ZEROING CO2 SENSOR” displays.
5. After warm-up and zeroing is complete, connect the sensor to the “REF” cell, located on the Capnostat sensor cable, for at least 5 seconds.
6. Verify that the displayed CO mmHg.
7. Press the “Wave2” softk ey. Verif y that the capnogram waveform appears as a straight line at approximately 38mmHg.
8. Verify that the patient alarms are functional by entering the alarm menu, selecting enable, and setting the low EtCO2 alarm limit to 45. Press ”Return” and then ALARM SUSPEND. Verify that the alarm tone is issued, the alarming parameter’s value is highlighted, and the alarm bell flashes on the display. Repeat with the EtCO
low alarm set at 30 and the high alarm set
2
at 35.
9. Remove the sensor from the reference cell and verify that “CHECK CO2 ADAPTER” appears in the message area of the graphic display and a two beep audio tone sounds.
When not in use, place Capnostat sensor on the zero cell.
sensor cable to the rear of the
sensor to warm up and zero (if
2
value is 38mmHg +/- 2
2
EtCO2 - 10
Page 13
End Tidal CO
2

DEFAULT SETTINGS

When the EtCO2 option is turned on, the following default settings are automatically selected and remain in operation until changed.
Parameter Default Setting Range
High EtCO2 Alarm Limit 55 mmHg 5 to 100 mmHg, OFF Low EtCO2 Alarm Li mit 25 mmHg 0 to 95 mmHg, OFF High Respiration Rate Alarm Limit 120 respirations per minute 5 to 150 respirations per minute, OFF Low Respiration Rate Alarm Limit 5 respirations per minute 0 to 100 respirations per minute, OFF Averaging Mode 10 seconds 1 breath
10 seconds 20 seconds
NOTE: The power on default settings for the capnogram waveform scale and CO2 compensation are set in System Configuration, as are the power-on default settings for alarm limits. See the M Series Configuration Guide for more information.
9650-0212-01 EtCO2 - 11
Page 14
OPTION INSERT

MESSAGES AND TROUBLESHOOTING

The following chart lists the messages and symptoms that may appear on the M Series unit relating to EtCO2, why the message appeared, and the action(s) to take if the message indicates a problem.
The operator should become thoroughly familiar with this information before monitoring patients.
Message/Symptom Description User Action
CHECK CO2 SENSOR Sensor cable not properly plugged in or over temperature. Check that sensor cable is
plugged in and seated properly.
Check sensor is not exposed to excessive heat. If problem
persists, replace sensor. CO2 OUT OF RANGE Dashed lines for CO2. WARM UP Sensor is warming up. This takes up to 5 minutes. Wait for sensor to warm up
REPLACE CO2 SENSOR When “WARM UP” message is displayed for more than 5
“ZERO CO2 ADAPTER?” and “CHECK CO2 ADAPTER” altern ate.
“ZERO CO2 SENSOR” and “PLACE ON ZERO CELL” alternate
ZEROING CO2 SENSOR Sensor Zeroing in progress. This is started when the
USE ROOM AIR ADAPTER
ZEROING CO2 ADAPTER Adapter zeroing in progress. Wait for adapter zeroing to
CO2 COMM ERROR No or invalid communication from the EtCO2 module. Return for service. CO2 UNIT ERROR Defective EtCO2 module. Return for service. Dash lines at top of
waveform capnogram CO2 numeric value display
dash lines.
Calculated CO2 value is greater than 100mmHg. Gas mixture is beyond the
maximum range of the sensor.
(max 5 minutes).
Replace sensor.
minutes, this m ess age will be displayed. Sensor is defective or incompatible.
Airway adapter removed, occluded, or Adapter Zeroing needs to be performed or was performed incorrectly – for example if CO2 was present in the adapter during zeroing.
Sensor cable plugged into M Series for the first time. Zeroing error or probe drift error detected.
sensor is placed on the zero cell. Adapter zeroing started with CO2 in the adapter, or the
adapter is on the “REF” or “0” cell.
Scale value setting incorrect. Measured CO2 higher than scale limits.
After a defibrillation discharge, the numeric value will display “- - -“ for approxim at ely 10 seconds.
Replace/Clean airway adapter.
Check/perform adapter zer o.
Place sensor on the zero cell.
Zeroing performed
automatically.
Wait for sensor zeroing to
finish.
Place CO2 sensor on adapter
in room air.
finish.
Adjust to higher scale setting.
None, normal operation
EtCO2 - 12
Page 15

SPECIFICATIONS

Principle of Operation
Sensor Type Warm up Time Rise Time Delay Time System Response Time End Tidal CO2 (EtCO2) Range End Tidal CO2 (EtCO2) Accuracy End Tidal CO2 (EtCO2) Resolution EtCO2 Stability
Respiration Rate (RR) Range and Accuracy
Respiration Rate (RR) Resolution EtCO2 Alarm Limits Respiration Rate (RR) Alarm Limits
EtCO2 Alarm Accuracy O2/N2O Compensation Halogenated Agents
Barometric Pressure Compensation Range Airway Adapter Deadspace Environmental
End Tidal CO
Non-Dispersive Infrared (NDIR) absorption, dual wavelength ratiometric-True Single Beam Optics; Complies with conditions on BTPS (Body Temperature and Pressure, Saturated): EtCO pressure of CO
Mainstream Operational in 15 seconds, full specification within 60 seconds <60 mS adult and =< 50 mS neonate <35 mS adult and =< 25 mS neonate <95 mS adult and =< 75 mS neonate 0 - 100mmHg 0 - 40mmHg ± 2 mmHg, 41 – 70 mmHg +/- 5%, 71 – 100mmHg +/-8% 1 mmHg +/- 2mmHg or +/- 5% of reading (whichever is greater), 1 – 100mmHg
over 8 hours without re-zero 0 – 150 respirations per minute (averaged over the last 8 breaths)
± 1 resp/min 1 breath/min User selectable, High 5 to 100mmHg, Low 0 to 95 mmHg, OFF User selectable, High 5 to150 respirations per minute, Low 0 to100
respirations per minute, OFF 0 - 40mmHg ± 2 mmHg, 41 – 70 mmHg +/- 5%, 71 – 100mmHg +/- 8% User selectable Specification allows for halogenated anesthetic agents that may be
present at normal clinical levels. The presence of desflurane in the exhaled breath beyond normal values (5-6%) may positively bias Carbon Dioxide values by up to an additional 2-3 mmHg.
550 – 780 mmHg (automatic) Adult < 5cc, Neonatal < .5 cc Operating Temperature: 10° to 40°C
Storage and Shipping Temperature: -10° to 55° C
in the expiratory gas.
2
= partial
2
2
The M Series device may not perform to specifications when stored at the upper or lower extreme limits of storage temperature and
Electromagnetic Immunity ETCO
Option)
2
Software Hazards Operating Time
(EtCO
and SpO2 Options)
2
immediately put into use. AAMI DF-2: IEC 1000-4-3, 15 V/m
Minimized by compliance with EN1441 For a new, fully charged battery pack at 20°C: 35 defibrillator
discharges at maximum energy (360J), or 1.5 hours minimum of continuous ECG monitoring, or 1.0 hour of continuous ECG monitoring/pacing at 60 mA, 70 beat s/ m in.
9650-0212-01 EtCO2 - 13
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