US E2d Capno Plus
US E2d Capno Plus
US E2d Capno Plus
Addendum to
Evita 2 dura
Operating Instructions
1-256-96
NOTICE
Proprietary Information
This document contains information in which Draeger Medical, Inc.
claimed proprietary rights. The information may not be reproduced in
whole or in part except as authorized in writing by Draeger. This infor-
mation is the property of Draeger Medical, Inc., it is provided solely for
the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DraegerService or its
Authorized Service Centers. Information about repairs can be obtained
from Draeger or Authorized Dealers. Draeger Medical, Inc. will not be
responsible for injury to persons or damage to property arising directly
or indirectly out of unauthorized repairs or modifications to this device.
Furthermore, any unauthorized repairs or modifications void any warran-
ty extended by Draeger.
Trademarks
The Draeger name and logo are registered trademarks of Drägerwerk
Aktiengesellschaft.
CapnoPlus is a trademark of Drägerwerk Aktiengesellschaft.
Dräger Medizintechnik GmbH,1999
All rights reserved, Subject to modifications
Contents
Contents
Intended Use.............................................................. 8
Preparation................................................................. 9
Before First Use........................................................... 9
Installing Cuvette and CO2 Sensor............................ 10
Configuring CO2 Waveform....................................... 11
CO2 Calibration......................................................... 11
Measuring CO2..........................................................13
Displaying CO2 Waveform ........................................ 13
Setting Alarm Limits for etCO2 .................................. 13
Switching Off Monitoring Functions ........................... 12
Care...........................................................................20
Disassembly............................................................... 20
Disinfecting/Cleaning................................................. 21
Troubleshooting ....................................................... 23
Maintenance..............................................................24
Maintenance Intervals................................................. 24
Operating Instructions Evita 2 dura CapnoPlus
Technical Data.......................................................... 25
Theory of Operation.................................................. 27
Physiological Capnogram........................................... 27
Abbreviations Explained..............................................29
Bibliography............................................................... 29
Ordering Information................................................ 30
Index......................................................................... 31
3
Important Safety Information
Operator's Responsibility for Patient Safety
Limitation of Liability
For correct and effective use of the product and in Draeger Medical, Inc.'s liability, whether arising out of
order to avoid hazards it is mandatory to carefully or related to manufacture and sale of the goods, their
read and to observe all portions of this manual. installation, demonstration, sales representation, use,
performance, or otherwise, including any liability based
upon Draeger Medical, Inc.'s Product Warranty, is sub-
The design of the intensive care ventilators this device ject to and limited to the exclusive terms and conditions
is intended to be used with, accompanying literature, as set forth, whether based upon breach of warranty or
and the labeling on the equipment take into considera- any other cause of action whatsoever, regardless of
tion that the purchase and use of the equipment are any fault attributable to Draeger Medical, Inc. and re-
restricted to trained professionals, and that certain gardless of the form of action (including, without
inherent characteristics of the equipment are known to limitation, breach of warranty, negligence, strict liability,
the trained operator. Instructions, warnings, and or otherwise).
caution statements are limited, therefore, largely to the
THE STATED EXPRESSED WARRANTlES ARE IN
specifics of the Draeger design. This publication
LlEU OF ALL OTHER WARRANTIES, EXPRESSED
excludes references to various hazards which are
OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
obvious to a medical professional and operator of
respiratory care equipment, to the consequences of WARRANTlES OF MERCHANTABILITY, FITNESS
misuse of such equipment, and to potentially adverse FOR ANY PARTICULAR PURPOSE, OR
effects in patients with abnormal conditions. Product NONINFRINGEMENT.
modification or misuse can be dangerous. Draeger Draeger Medical, Inc. shall not be liable for, nor shall
Medical, Inc. disclaims all liability for the consequences buyer be entitled to recover any special incidental, or
of product alterations or modifications, as well as for consequential damages or for any liability incurred by
the consequences which might result from uses of the buyer to any third party in any way arising out of or re-
product not covered by its intended use or from the lating to the goods.
combination of this product with other products
whether supplied by Draeger or by other manufacturers
if such a combination is not endorsed by Draeger Medi-
cal, Inc..
4
Important Safety Information
Warranty
Warranty
All Draeger products are guaranteed to be free of Application of this warranty is subject to the following
defects for a period of one year from date of delivery. conditions:
The following are exceptions to this warranty:
1. Draeger Medical, Inc. or its authorized representa-
1. The defect shall be a result of workmanship or tive must be promptly notified, in writing, upon de-
material. Defects caused by misuse, mishandling, tection of the defective material or equipment.
tampering, or by modifications not authorized by
2. Defective material or equipment must be returned,
Draeger Medical, Inc. or its representatives are not
shipping prepaid, to Draeger or its authorized
covered.
representative.
2. Rubber and plastic components and materials are-
3. Examination by Draeger Medical, Inc. or its author-
warranted to be free of defects at time of delivery.
ized representative must confirm that the defect is
3. Oxygen sensors capsules have a six-month limited covered by the terms of this warranty.
warranty from the date of delivery.
4. Notification in writing, of defective material or
Any product which proves to be defective in workman- equipment must be received by Draeger Medical,
ship or material will be replaced, credited, or repaired Inc. or its authorized representative no later than
with Draeger Medical, Inc. holding the option. Draeger two (2) weeks following expiration of this warranty.
Medical, Inc. is not responsible for deterioration, wear, or
In order to assure complete protection under this
abuse. In any case, Draeger Medical, Inc. will not be li-
warranty, the Customer Registration Card and/or Peri-
able beyond the original selling price.
odic Manufacturer's Service Record (if applicable)
must be returned to Draeger within ten (10) days of
receipt of the equipment.
The above is the sole warranty provided by Draeger
Medical, Inc. No other warranty expressed or implied is
intended. Representatives of Draeger are not autho-
rized to modify the terms of this warranty.
5
Important Safety Information
Definitions
General WARNINGS and CAUTIONS
WARNING ! WARNING !
A WARNING statement refers to conditions Strictly follow Operator's Instruction Manuals
with a possibility of personal injury if dis- Any use of the product requires full under-
regarded. standing and strict observation of all portions
of these instructions as well as the Operating
Instructions of the Evita 2 dura ventilator. The
equipment is only to be used for the purpose
specified under "Intended Use" (page 8). Ob-
serve all WARNINGS and CAUTIONS as ren-
dered throughout the manuals and on labels
CAUTION ! on the equipment.
A CAUTION statement designates the possibility
of damage to equipment if disregarded.
WARNING !
DANGER, risk of explosion if used in the
presence of flammable anesthetics.
NOTE: A NOTE provides additional information
intended to avoid inconveniences during operation. The equipment is neither approved nor certi-
fied for use in areas where combustible or
explosive gas mixtures with air or with nitrous
oxide are likely.
Inspection = examination of actual condition
Service = measures to maintain specified
condition WARNING !
Repair = measures to restore specified Electrical connections to equipment which is
condition not listed in these Operating Instructions
should only be made following consultations
Maintenance = inspection, service, and repair, with the respective manufacturers or a
where necessary qualified expert.
Traceability
»Limits«
Federal Law in the United States requires trace-
On-screen messages are printed in bold, e.g. ability of this equipment. Please return the self
addressed registration card included with the
etCO2 calibration OK. product and fill in the required information.
CAUTION !
Accessories
Use only accessories listed in the Ordering
Information (page 30).
6
Introduction
Precautions During Preparation
WARNING ! WARNING !
Installation of the Evita 2 dura CapnoPlus Op- To avoid any risk of infection, clean and dis-
tion may be performed by factory trained and infect ventilator and accessories before any
authorized service personnel only. maintenance according to established hos-
pital procedures - this applies also when
returning ventilators or parts for repair.
7
Intended Use
Intended Use
8
Preparation
Installation
Before First Use
Preparation
Installation
WARNING !
Installation of the Evita 2 dura CapnoPlus
option may be performed by factory trained
and authorized service personnel only.
Under Units:
● Select »CO2« screen field = turn dial knob.
Confirm = press dial knob.
The list of available units of measurement will appear.
Display (example):
Operating Instructions Evita 2 dura CapnoPlus
Vol.%
mmHg
kPa
9
Preparation
Installing Cuvette and CO2 Sensor
10
Preparation
Configuring CO2 Waveform
CO2 Calibration
– if the ventilator requests CO2 calibration with the
screen message: CO2 calibration?
– if the CO2 waveform no longer returns to zero after
each expiration
– before each test of CO2 calibration, see page 15,16.
– before each CO2 sensor calibration, see page 18.
After switching on Evita 2 dura, wait for the 3 minute
warm-up phase to be completed, until message:
CO2 warm-up has disappeared.
Operating Instructions Evita 2 dura CapnoPlus
11
Preparation
CO2 Calibration
Display (example):
Message:
Park CO2 sensor. Confirm with
2
Evita 2 dura
Message:
CO2 zero calibration
Operating Instructions Evita 2 dura CapnoPlus
12
Measuring CO2
Displaying CO2 Waveform
Setting Alarm Limits for etCO2
Measuring CO2
Displaying CO2 Waveform
● Press »Waves« key.
mmHg CO2
80
60
40
20
0
0 2 4 s
Adjustment Factory-set
range start-up defaults
––––––––––––––––
* see also Theory of Operation, "Physiological Capnogram, p. 27
13
Measuring CO2
Switching Off Monitoring Functions
WARNING !
In case of malfunction of any of the built-in
monitoring a substitute has to be provided in
order to maintain an adequate level of moni-
toring. The operator of the ventilator must still
assume full responsibility for proper ventila-
tion and patient safety in all situations.
Display (example):
● Select »CO2« screen key = turn dial knob.
● Switch off CO2 monitoring = press dial knob.
14
Testing/Calibrating the CO2 Sensor
Testing CO2 Calibration With Test Filter
Display (example):
15
Testing/Calibrating the CO2 Sensor
Testing CO2 Calibration With Calibration Gas
Display (example):
Operating Instructions Evita 2 dura CapnoPlus
16
Testing/Calibrating the CO2 Sensor
Testing CO2 Calibration With Calibration Gas
17
Testing/Calibrating the CO2 Sensor
Calibrating CO2 Sensor
Display (example):
Kalibriergas
Calibration gas,z.B.:
e.g.
55Vol.-% CO2 2
Vol.-% CO
9595Vol.-%
Vol.-% NN2 2
18
Checking/Calibrating the CO2 Sensor
Resetting CO2 Calibration
19
Care
Disassembly
Care
Disassembly
Clean and process ventilator after each patient.
WARNING !
Always follow accepted hospital procedures
for handling equipment contaminated with
body fluids.
3
Operating Instructions Evita 2 dura CapnoPlus
20
Care
Disinfecting/Cleaning
Disinfecting/Cleaning
CAUTION !
Certain components of the ventilator and its
accessories consist of materials that are sensi-
tive to certain organic solvents sometimes used
for cleaning and disinfec-ting (e.g., phenols,
halogen releasing com-pounds, oxygen releasing
compounds, strong organic acids, etc.). Expo-
sure to such substan-ces may cause damage
that is not always immediately recognized.
Sterilization with ethylene oxide (EtO) is also not
recommended.
WARNING !
Follow all accepted hospital procedures for
disinfecting parts contaminated by body fluids
(protective clothing, eyewear, etc.).
Operating Instructions Evita 2 dura CapnoPlus
21
Care
Disinfecting/Cleaning
CO2 Cuvette
● Wipe off any obvious soiling with disposable tissue
and cotton swabs, in particular inside and outside the
windows.
● Disinfect in a moisture saturated environment at
93 °C (200 °F) for 10 minutes using a cleaning and
disinfecting machine. Use detergent only.
Or:
● Bath disinfect using a disinfectant based on the
suggested active substances, e.g. Cidex, Johnson &
Johnson
Or:
● Steam-autoclave at 134 °C (273 °F).
CO2 Sensor
● Wipe off any obvious soiling with cotton swabs, in
particular on the windows of the CO2 sensor.
● Wipe-disinfect, e.g. with 70% ethanol or a similar
agent.
After processing
● Reinstall cuvette and CO2 sensor, see page 10.
22
Troubleshooting
Troubleshooting
Alarm messages in the alarm display field are displayed In the table below, the messages are listed in alpha-
in hierarchical order. betical order.
If, for example, two faults are detected at the same time, The table should help you to identify the cause of an
the more urgent of the two is displayed. alarm and to ensure rapid remedy of the problem.
The priority for alarm messages is indicated by
exclamation marks:
Warning = Message with top priority !!!
Caution = Message with medium priority !!
Advisory = Message with low priority !
CO2 sensor !!! CO2 sensor probe removed during Reinsert probe.
operation.
Clean CO2 cuvette !!! Cuvette window dirty. Use a clean cuvette.
Sensor window dirty Clean CO2 sensor
CO2 calibration? !!! Zero point out of tolerance. Perform CO2 calibration, pages 11,12.
CO2 monitoring off ! CO2 monitoring is switched off. Switch CO2 monitoring back on, see
page 14 or immediately provide adequate
external monitoring
CO2 measurement inop !!! CO2 sensor defective. Replace defective CO2 sensor.
23
Maintenance
Maintenance Intervals
WARNING !
To avoid any risk of infection, clean and
disinfect ventilator and accessories before any
maintenance according to established
hospital procedures - this applies also when
retur-ning ventilators or parts for repair.
WARNING !
Preventive Maintenance work on the Evita 2
dura ventilator and its components may be
performed by trained and factory authorized
staff only.
WARNING !
Never operate the ventilator if it has suffered
physical damage or does not seem to operate
properly. In this case always refer servicing to
properly trained and factory authorized service
Operating Instructions Evita 2 dura CapnoPlus
personnel.
24
Technical Data
Technical Data
Environmental conditions
During operation
Temperature 10 to 40 °C (50 to 104 °F)
Atmospheric pressure 670 to 1200 hPa
Rel. humidity 10 to 100 % (no condensation)
During storage and transport
Temperature –10 to 60 °C (14 to 140 °F)
Atmospheric pressure 670 to 1200 hPa
Rel. humidity 10 to 100 % (no condensation)
Performance data
End-expiratory CO2 concentration etCO2
Range 0 to 100 mmHg or
0 to 13.3 Vol.% or
0 to 13.3 kPa
Resolution 1 mmHg or
0.1 Vol.% or
0.1 kPa
Accuracy
for 0 to 40 mmHg ±2 mmHg
for 40 to 100 mmHg ±5 % of measured value
T 10...90 ≤ 25 ms
Warm-up time max. 3 minutes
CO2 production * CO2
Range 0 to 999 mL/min, (STPD)*
Resolution 1 mL/min
Accuracy ±9 % of measured value
T 10...90 12 minutes
Serial dead space Vds
Range 0 to 999 mL, (STPD)*
Resolution 0.1 mL
Accuracy ±10 % of measured value or ±10 mL,
whichever is greater
Dead space ventilation Vds/VT
Operating Instructions Evita 2 dura CapnoPlus
Range 0 to 99 %
Resolution 1%
Accuracy ±10 % of measured value
––––––––––
* STPD = Standard Temperature Pressure, Dry
Measured values referred to standard physical conditions: 0 °C, 1013 mbar, dry.
25
Technical Data
Dead space:
including adult size cuvette 16 mL
including pediatric size cuvette 6 mL
Weight
Sensor 30 g (1.1 oz.)
Cuvette 8 g (0.3 oz.)
Alarm at upper alarm limit for etCO2 when upper threshold is exceeded
Setting range 1 to 100 mmHg
or
0 to 15 kPa
or
0 to 15 Vol.%
Factory-set default at start-up 60 mmHg
Alarm at lower alarm limit for etCO2 when lower threshold is exceeded
Setting range 0 to 99 mmHg
or
0 to 14.9 kPa
or
0 to 14.9 Vol.%
Factory-set default at start-up 30 mmHg
Protection class I, type BF
CO2 sensor type BF m
Materials:
CO2 cuvette polysulphone with glass windows
CO2 sensor and cable polyurethane
26
Theory of Operation
Physiological Capnogram
Theory of Operation
Physiological Capnogram
Waveform segment 1 - 2
Emptying upper airway deadspace
CO2 concentration during this waveform segment is
zero. This is the initial expiratory phase where the CO2
analyzed gas comes from the upper airways and the ET-
3 4
tube and has not participated in alveolar gas exchange.
Waveform segment 2 - 3
1 2 5
Gas from lower airways and alveoli
Expiration Inspiration
CO2 concentration shows a sharp rise because the
analyzed gas partially comes from the lower airways and
partially from CO2-rich alveoli.
Waveform segment 3 - 4
Alveolar gas
This pase is called the "alveolar plateau".
CO2 concentration increases only gradually. Analyzed
gas is mostly from alveolar areas of the lung.
Time mark 4
endexpiratory CO2 partial pressure
Marks the highest concentration of exhaled CO2 and is
reached at the end of expiration. This value is known as
end-tidal CO2 (etCO2) and represents the last portion of
gas that has participated in alveolar gas exchange.
In humans with healthy lungs, endexpiratory CO2 partial
pressure is, on average, 4 mmHg lower than arterial
CO2 pressure. It is therefore an indicator for CO2 partial
pressure in arterial blood.
The difference between CO2 partial pressure as meas-
ured arterially or in the endexpiratory gas can increase
significantly in the presence of an impaired perfusion
ventilation ratio.
Operating Instructions Evita 2 dura CapnoPlus
Waveform segment 4 - 5
Inspiration
CO2 concentration falls quickly as fresh, CO2-free gas
enters the airways.
––––––––––––––
* J. Baum, Anaesthesiol. Reanimation. 16 (1991) No. 1. 12-22
27
Theory of Operation
Physiological Capnogram
B
t
Vexp. Expiratory
Volume
VT C
During expiration, CO2 produced through a patient's
metabolism is transported to the environment via
pulmonic circulation and the lungs. VDS
It is therefore that endexpiratory CO2 concentration
(etCO2) and the shape of the expiratory CO2 wave-
form (capnogram) provide rapid diagnostic information t
TE
about all three areas (ventilation, perfusion, and metabo-
lism).
28
Theory of Operation
Abbreviations Explained
Bibliography
Abbreviations Explained
Bibliography
J. Baum, Anaesthesiol. Reanimation. 16 (1991)
No. 1. 12-22
Operating Instructions Evita 2 dura CapnoPlus
29
Ordering Information
Ordering Information
Item/Description Part No.
Evita 2 dura CapnoPlus
Capnography option for Evita 2 dura 84 13 780
Replacement parts:
Cuvette, adult size 68 70 279
Cuvette, pediatric size 68 70 280
30
Index
Index
Abbreviations............................................................. 29
Advisory....................................................................... 6
Alarm..........................................................................23
Alarm limits................................................................. 13
Bibliography............................................................... 29
Capnogram................................................................ 27
Care........................................................................... 20
Caution........................................................................ 6
CO2 calibration...........................................................11
CO2 calibration, checking with test filter..................... 15
CO2 calibration, checking with test gas...................... 16
CO2 calibration, reset................................................. 19
CO2 waveform, displaying......................................... 13
CO2 waveform, configuring........................................ 11
CO2, units of measurement.......................................... 9
CO2 sensor, installing.................................................10
CO2 sensor, calibrating.............................................. 18
Cuvette, installing....................................................... 10
Disassembly............................................................... 20
Disinfecting/cleaning...................................................21
First use....................................................................... 9
Intended use................................................................ 8
Literature.................................................................... 29
Ordering information...................................................30
Preparation.................................................................. 9
Safety information.........................................................4
Technical data............................................................ 25
Operating Instructions Evita 2 dura CapnoPlus
Testing/Calibrating......................................................15
Troubleshooting.......................................................... 23
Warning....................................................................... 6
31
These Operating Instructions apply only
to Evita 2 dura with Serial No.:
Without entry of a Serial No. by Draeger
these Operating Instructions are provided
for general information only and are not
intended for use with a specific device.