D Vapor and D-Vapor 3000 Instructions for Use Edition 9 June 2012.pdf
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5. November 2012, 14:53
Instructions for Use
D-Vapor/D-Vapor 3000
WARNING
To properly use this medical device,
read and comply with these
Instructions for Use.
Anesthetic vaporizers
Page 2
Working with these Instructions for Use
The title of the main chapter in the header line
helps with orientation and navigation.
–
The Instructions for Use combine text and
illustrations, providing a comprehensive overview
of the system. The information is presented as
sequential steps of action, allowing the user to learn
directly how to use the device.
A Letters denote elements referred to in the text.
The text provides explanations and instructs the
user step-by-step in the practical use of the
product, with short, clear instructions in easy-tofollow sequence.
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
relevant illustration.
The illustrations show the relationship between
the text and the device. Elements mentioned in the
text are highlighted. Unnecessary details are
omitted.
These Instructions for Use apply to D-Vapor and
D-Vapor 3000 anesthetic vaporizers. If information
only applies to one model of Vapor, this is noted in
the heading or in the corresponding part of the text.
z Bullet points indicate individual actions or
different options for action.
Trademarks
–
D-Vapor®
is a trademark of Dräger.
–
Selectatec®
is a trademark owned by Datex-Ohmeda.
–
Suprane®
is a trademark of Baxter International Inc.
2
Instructions for Use D-Vapor/D-Vapor 3000
Page 3
Safety Information Definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important
information about a potentially hazardous
situation which, if not avoided, may result in minor
or moderate injury to the user or patient or in
damage to the medical device or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Definitions of the Target Groups
For this medical device users, service personnel,
and experts are defined as target groups.
Service personnel
These traget groups have been instructed in the
use of the medical device and have the necessary
knowledge, expertise, and training.
Service personnel can be an individual or a group
of persons responsible towards the operating
organization.
Dräger emphasizes that the medical device must
be used, installed, reprocessed, or maintained
exclusively by defined target groups
Service personnel are persons who may instal,
reprocess, or maintain the medical device.
Experts
Users
Users are persons who may use the medical device
in accordance with its intended use.
Instructions for Use D-Vapor/D-Vapor 3000
Experts are persons who may carry out complex
maintenance work on the medical device.
3
Page 4
Abbreviations and Symbols
Please refer to "Abbreviations" on page 22 and
"Symbols" on page 23 for explanations.
4
Instructions for Use D-Vapor/D-Vapor 3000
Page 5
Contents
Contents
For Your Safety and that of Your Patients . .
7
General Safety Information. . . . . . . . . . . . . . . . 8
Product-specific safety information. . . . . . . . . . 10
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environment of Use . . . . . . . . . . . . . . . . . . . . . 14
System overview . . . . . . . . . . . . . . . . . . . . . . 15
Comparison D-Vapor with D-Vapor 3000 . . . . .
Overview of functions . . . . . . . . . . . . . . . . . . . .
D-Vapor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
D-Vapor 3000 . . . . . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16
17
18
20
22
23
Operating Concept . . . . . . . . . . . . . . . . . . . . . 25
Operating states . . . . . . . . . . . . . . . . . . . . . . . .
Control dial . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection and Interlock systems for
D-Vapor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection and Interlock systems for
D-Vapor 3000 . . . . . . . . . . . . . . . . . . . . . . . . . .
Filling systems . . . . . . . . . . . . . . . . . . . . . . . . .
Position of the user. . . . . . . . . . . . . . . . . . . . . .
26
27
29
32
33
34
Disconnecting the Vapor . . . . . . . . . . . . . . . . . 63
Transport when filled . . . . . . . . . . . . . . . . . . . . 65
Shut-down – draining the Vapor . . . . . . . . . . . 65
Blowing off the Vapor. . . . . . . . . . . . . . . . . . . . 68
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Dispatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
71
Alarm Concept. . . . . . . . . . . . . . . . . . . . . . . . . 72
Secondary Audible Alarm System. . . . . . . . . . 73
Suppressing the Alarm Tone . . . . . . . . . . . . . . 73
Problem solving . . . . . . . . . . . . . . . . . . . . . .
75
Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
76
Cleaning and disinfection. . . . . . . . . . . . . . .
85
Safety information for preparation . . . . . . . . . . 86
Preparatory procedure . . . . . . . . . . . . . . . . . . 87
Before reusing on the patient . . . . . . . . . . . . . 88
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . .
89
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
93
Before first use . . . . . . . . . . . . . . . . . . . . . . . . .
Fitting connectors . . . . . . . . . . . . . . . . . . . . . . .
Filling the Vapor . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the Vapor . . . . . . . . . . . . . . . . . . . .
Establishing electrical connections. . . . . . . . . .
Disposal of a medical device. . . . . . . . . . . . . .
Battery disposal. . . . . . . . . . . . . . . . . . . . . . . .
94
94
36
37
40
45
49
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Checking that the unit is ready for use . . . . . . .
Putting into operation . . . . . . . . . . . . . . . . . . . .
Switching on and self test. . . . . . . . . . . . . . . . .
Adjusting concentration of anesthetic agent. . .
Changing the anesthetic agent. . . . . . . . . . . . .
Ending delivery of anesthetic agent . . . . . . . . .
Operation during power failure (battery
operation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
End of use . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instructions for Use D-Vapor/D-Vapor 3000
52
56
59
60
61
62
62
63
Technical Data . . . . . . . . . . . . . . . . . . . . . . . .
95
Classifications . . . . . . . . . . . . . . . . . . . . . . . . .
Ambient conditions . . . . . . . . . . . . . . . . . . . . .
Performance characteristics . . . . . . . . . . . . . .
Pneumatic interfaces. . . . . . . . . . . . . . . . . . . .
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical characteristics . . . . . . . . . . . . . . . . .
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weight and dimensions D-Vapor . . . . . . . . . . .
Weight and dimensions D-Vapor 3000 . . . . . .
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . .
96
96
96
99
99
100
100
101
101
102
Description. . . . . . . . . . . . . . . . . . . . . . . . . . . 107
5
Page 6
Contents
Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
D-Vapor 3000 . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Influence of temperature . . . . . . . . . . . . . . . . . 109
Influence of flow . . . . . . . . . . . . . . . . . . . . . . . . 110
Influence of gas type and composition . . . . . . . 111
Influence of atmospheric pressure and
altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Correction of the flow measurement under
the influence of desflurane . . . . . . . . . . . . . . . . 112
List of Accessories . . . . . . . . . . . . . . . . . . . . 113
Quality Inspection Certificate . . . . . . . . . . . . 115
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
6
Instructions for Use D-Vapor/D-Vapor 3000
Page 7
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
General Safety Information . . . . . . . . . . . . . .
8
Strictly follow these Instructions for Use . . . . . . 8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connected devices . . . . . . . . . . . . . . . . . . . . . . 9
Not for use in areas of explosion hazard . . . . . 9
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9
Keeping the Instructions for Use . . . . . . . . . . . 9
Information on Electromagnetic
Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Product-specific safety information . . . . . . . 10
Essential performance . . . . . . . . . . . . . . . . . . . 12
Additional safety information for
D-Vapor 3000 . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Instructions for Use D-Vapor/D-Vapor 3000
7
Page 8
For Your Safety and that of Your Patients
General Safety Information
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
Instructions for Use or in the Instructions for Use of
another product being used with this device.
Strictly follow these Instructions for Use
WARNING
Risk of operating error and incorrect use
Any use of the medical device requires full
understanding and strict observation of all
sections of these Instructions for Use. This
medical product may only be used for the
purpose specified under "Intended use"
on page 14. Strictly observe all WARNING and
CAUTION statements throughout these
Instructions for Useand all statements on
medical device labels.
Failure to observe these safety information
statements constitutes a use of the medical
device that is inconsistent with its intended
use.
Maintenance
WARNING
Risk of malfunction of the medical device and
risk of patient injury
The medical device must be inspected and
serviced regularly by service personnel.
Repairs and complex maintenance activities
on the medical device must be carried out by
experts. Dräger recommends taking out a
service contract with and having all repairs
carried out by DrägerService. Dräger further
recommends that only authentic Dräger parts
are used for maintenance.
If the above are not complied with, the correct
functioning of the medical device may be
compromised. See chapter "Maintenance".
Safety checks
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Accessories
WARNING
Risk resulting from incorrect accessories
Only the accessories indicated on the list of
accessories (see page 113) have been tested
and approved to be used with the medical
device.
Therefore, it is strongly recommended that
only these accessories are used in
conjunction with the medical device.
Otherwise, the correct functioning of the
medical device may be compromised.
8
Instructions for Use D-Vapor/D-Vapor 3000
Page 9
For Your Safety and that of Your Patients
Connected devices
WARNING
Risk of electric shock and of device
malfunction
Any connected devices or device
combinations not complying with the
requirements mentioned in these Instructions
for Use may compromise the correct
functioning of the medical device. Before
operating any combination of devices, refer to
and strictly comply with the Instructions for
Use for all connected devices and device
combinations.
Not for use in areas of explosion hazard
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
Safe connection with other electrical
equipment
WARNING
Risk of patient injury
Electrical connections to equipment not listed
in these Instructions for Use or these
Assembly Instructions must only be made
when approved by each respective
manufacturer.
Patient safety
The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to users, and that certain inherent
characteristics of the medical device are known to
the user. Instructions and WARNING and
CAUTION statements are therefore largely limited
to the specifics of the Dräger medical device.
These Instructions for Use do not contain
references to various hazards which are obvious to
professionals who operate this medical device as
well as references to the consequences of medical
device misuse, and to potentially adverse effects in
patients with different underlying diseases. Medical
device modification or misuse can be dangerous.
Patient monitoring
The user of the medical device is responsible for
choosing suitable monitoring that provides
appropriate information about medical device
performance and the patient's condition.
Patient safety may be achieved by a wide variety of
means ranging from electronic surveillance of
medical device performance and patient condition
to simple, direct observation of clinical signs.
The responsibility for selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Keeping the Instructions for Use
CAUTION
Risk of operating error
The Instructions for Use must be kept accessible
to the user.
Instructions for Use D-Vapor/D-Vapor 3000
9
Page 10
For Your Safety and that of Your Patients
Information on Electromagnetic
Compatibility
WARNING
Risk of device failure
General information on electromagnetic
compatibility (EMC) according to international
EMC standard IEC 60601-1-2:
Portable and mobile RF communications
equipment can affect medical electrical
equipment.
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information provided on page 102.
Product-specific safety information
WARNING
Risk of device errors
WARNING
Risk of patient injury
Various potentially dangerous situations can
arise that require the user's attention.
Damage to the Vapor can cause incorrect
output concentrations and serious harm to
the patient.
Only use the device under the constant
supervision of users in order to provide a
prompt remedy in the event of a malfunction.
WARNING
Not permitted modifications
Modifications to the medical device that are
not permitted may lead to malfunctions.
This medical device may not be modified
without the manufacturer's permission.
10
Handle the Vapor with care. Be careful not to
tilt or drop. Do not carry by the control dial, the
control dial caps or the locking lever for the
plug-in adapter.
Do not use the Vapor if it has been dropped.
Check the Vapor that has toppled over, see
Checking that the unit is ready for use,
page 52. If the check is not possible, do not
use the Vapor.
Instructions for Use D-Vapor/D-Vapor 3000
Page 11
For Your Safety and that of Your Patients
WARNING
Risk of patient injury
WARNING
Risk of patient injury
Incorrect concentrations of anesthetic agent
can harm the patient.
Risk of incorrect output concentration and
impeded breathing due to high breathing
resistance
Use continuous monitoring of the delivered
concentrations of anesthetic agent,
conforming to the ISO 21647 standard, with
upper and lower alarm limits to detect
deviations in concentration.
Ensure that the measuring instrument is
operational before using it.
WARNING
Risk of patient injury
Incorrect output concentrations will not be
detected when operating from the external
fresh-gas outlet.
An anesthetic gas monitor must be used if the
Vapor is used with anesthesia equipment via
the external fresh-gas outlet.
WARNING
Risk of patient injury
Device function can be interfered with.
Do not use the Vapor with magnetic
resonance imaging (MRI).
WARNING
Risk of patient injury
Deviation of the delivered concentration due
to filling the Vapor with incorrect anesthetic
agent.
Only fill the Vapor with desflurane.
The Vapor is not suitable for use in a breathing
system.
WARNING
Risk of patient injury
High desflurane settings reduce the O2
concentration in fresh gas.
High desflurane concentrations can affect hot
wire volume measurement! The indicated
volume will appear to be too high.
High frequency ventilation or the use of
anesthesia equipment with discontinuous
fresh-gas flow or repeated use of the O2 flush
can cause the Vapor to switch off.
Observe the Instructions for Use for the
anesthesia equipment.
WARNING
Risk of patient injury
Device functions can be manipulated or
switched off via the RS232 interface.
The available RS232 interface may only be
used for service purposes.
WARNING
Risk of an equipment fire
In the event of a fire at the patient's side, the
Vapor may ignite as a result.
In the event of a fire, disconnect the oxygen
conducting connections from the Vapor.
CAUTION
Health hazard
Take care not to spill anesthetic agent.
Do not inhale anesthetic agent vapors.
Instructions for Use D-Vapor/D-Vapor 3000
11
Page 12
For Your Safety and that of Your Patients
CAUTION
Risk of patient injury
Observe the instructions for use provided by the
manufacturer of the anesthetic agent. Pay
particular attention to the described indications,
contraindications, side-effects, MAC values, and
expiration date of the anesthetic agent used.
Essential performance
The essential performance of D-Vapor and
D-Vapor 3000 anesthetic vaporizers is the
enrichment of medical fresh gases with Desflurane
vapor and the generation of alarms in the event of
overpressure or underpressure in the internal
desflurane vapor supply.
Additional safety information for
D-Vapor 3000
WARNING
Risk of patient injury
The transfer of data to the anesthesia
workstation can be erroneous.
The indication of the control dial position on
the screen of an anesthesia workstation with
the Vapor View option is provided only for
information.
Only rely on the concentration that is set at the
Vapor.
WARNING
Risk of patient injury
The transfer of data to the anesthesia
workstation can be erroneous.
The indication of the filling level on the screen
of an anesthesia workstation with Vapor View
option serves only as information.
Only rely on the filling level at the Vapor.
WARNING
Risk of patient injury
The transfer of data to the anesthesia
workstation can be erroneous.
The indication of the detected, active Vapor
type on the screen of an anesthesia
workstation with the Vapor View option is
provided only for information.
Only rely on the anesthetic agent (color
coding, labeling) shown on the vaporizer.
12
Instructions for Use D-Vapor/D-Vapor 3000
Page 13
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environment of Use . . . . . . . . . . . . . . . . . . . . 14
Instructions for Use D-Vapor/D-Vapor 3000
13
Page 14
Application
Intended use
The D-Vapor/D-Vapor 3000 is a heated, calibrated
anesthetic vaporizer for enriching dry, medical
fresh gas of anesthesia workstations with vapor of
the anesthetic agent desflurane for the range of
concentrations from 2 to 18 Vol.%.
Environment of Use
D-Vapor/D-Vapor 3000 is intended for operation in
anesthesia workstations in hospitals and rooms
used for medical purposes.
Restrictions to the working area
D-Vapor/D-Vapor 3000 is not suitable for use in
rooms used for magnetic resonance imaging.
Installation and/or operation with anesthesia
workstations in moving vehicles, airplanes,
helicopters or ships is not permitted.
If there is a need for such an application, operation
is only permitted with the approval of the
manufacturer.
14
Instructions for Use D-Vapor/D-Vapor 3000
Page 15
System overview
System overview
Comparison D-Vapor with D-Vapor 3000 . . . 16
What is new with the D-Vapor 3000 design . . . 16
What is new with the D-Vapor 3000
functionality. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Overview of functions . . . . . . . . . . . . . . . . . . 17
D-Vapor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
D-Vapor 3000. . . . . . . . . . . . . . . . . . . . . . . . . . 20
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 22
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Instructions for Use D-Vapor/D-Vapor 3000
15
Page 16
System overview
Comparison D-Vapor with D-Vapor 3000
D-Vapor
D-Vapor 3000
Anesthetic agent
Desflurane (Des.)
Desflurane (Des.)
Connection and
Interlock system
Plug-in adapter DW-2000 with
Interlock 2
Dräger Auto Exclusion plug-in
adapter
Dräger Auto Exclusion plug-in
adapter
Plug-in adapter S-2000 with
Interlock S
Permanent connection
Conical connector
Filling system
1)
Baxter filling system for Suprane
(desflurane)
Baxter filling system for Suprane
(desflurane)
Desflurane Piramal Fill / Torane
Piramal Fill1)
Desflurane Piramal Fill / Torane
Piramal Fill1)
Country-specific name
Only the name "Desflurane Piramal Fill" is used in these Instructions for Use.
The filling system is not available in every country.
What is new with the D-Vapor 3000
design
–
When the refill mark is reached, a filling level
message is displayed on the anesthesia
workstation screen.
–
Ergonomically designed locking bar
–
–
Ergonomically designed control dial
The recognized active Vapor type is displayed
on the anesthesia workstation screen.
What is new with the D-Vapor 3000
functionality
Vapor View functions are only available for the
D-Vapor 3000 anesthetic vaporizer and cannot be
fitted to the D-Vapor anesthetic vaporizer.
D-Vapor 3000 has Vapor View functions.
Vapor View functions are only active in conjunction
with Dräger anesthesia workstations that have the
Vapor View option.
Vapor View functions:
–
The control dial is illuminated.
–
The inspection glass dial is illuminated.
–
The position of the control dial is transferred to
the anesthesia workstation as a setting value.
16
Instructions for Use D-Vapor/D-Vapor 3000
Page 17
System overview
Overview of functions
Each Vapor is calibrated for the anesthetic agent
specified on the device and is only suitable for that
anesthetic agent.
The delivered concentration is, for the most part,
not influenced by operating and ambient
conditions, such as temperature, gas flow and
ventilation pressure. See chapter Description,
page 109 to page 111.
The Vapor is inserted in the fresh-gas line of the
anesthesia workstation which typically delivers a
continuous fresh-gas flow. The Vapor is connected
between the fresh-gas metering unit and the freshgas outlet.
Proper functioning of the Vapor is dependent on the
direction of flow. The vaporizer must be connected
and operated in accordance with the direction of
flow specified on the device. The use of the Vapor
with different anesthesia workstations is therefore
only permissible and safe when it is used with the
appropriate special adapter. Simultaneous
operation of several Vapors connected in series is
not permissible, particularly for different anesthetic
agents.
The Vapor is not suitable for use with a breathing
system due to high pneumatic resistance.
D-Vapor/D-Vapor 3000 may only be used with
anesthesia equipment which conforms to one of the
following standards:
– IEC 60601-2-13
– ASTM F 1850
– CSA-Z 168.3
Instructions for Use D-Vapor/D-Vapor 3000
17
Page 18
System overview
D-Vapor
Front
A
L
K
J
I
H
G
I
Symbol, "Caution! Observe the accompanying
documents"
J
Indication of anesthetic agent and Vapor model
K Indication of concentration units
B
L 0 button for locking the control dial in the 0 or
T position
C
Display panel
D
A
E
B
C
max.
min.
D
E
F
A Control dial cap with color coding of the
anesthestic agent and Interlock code
B Control dial with concentration markings
C Sealing plug
D Unlocking button for the sealing plug
E Sight glass for displaying the filling level
F Display panel
053
071
F
A Yellow LED
Audio paused 2 min
B Green LED Operational
C Red LED No Output
D Red LED Delivery Low
E Yellow LED Fill Up
F Yellow LED Battery
G Button for suppressing the acoustic alarm for
2 minutes
H Protective cap for equipotential equilization pin
18
Instructions for Use D-Vapor/D-Vapor 3000
Page 19
System overview
Rear
A
B
C
D
G
E
002
F
A Locking lever on plug-in adapter
B Opening for Interlock locking device (illustrated:
Interlock 2)
C Slot for locking lever, so that the Vapor can only
be removed from the anesthesia workstation
when the control dial is in the T position.
D Connector system
(Illustration: Plug-in adapter DW-2000)
E Cover for RS232 interface
F Power cable
G Identification plate with manufacturer and
model information and Serial Number
Instructions for Use D-Vapor/D-Vapor 3000
19
Page 20
System overview
D-Vapor 3000
Front
H Protective cap for equipotential equilization pin
A
M
L
K
J
I
H
B
I
Symbol, "Caution! Observe the accompanying
documents"
J
Indication of anesthetic agent and Vapor model
K Indication of concentration units
L Window to allow light to exit for illumination
C
M 0 button for locking the control dial in the 0 or
T position
D
Display panel
A
max.
G
E
B
C
F
min.
D
E
003
F
053
A Control dial cap with color coding of the
anesthestic agent and Interlock code
B Control dial with concentration markings
A Yellow LED
C Sealing plug
B Green LED Operational
D Unlocking button for the sealing plug
C Red LED No Output
E Sight glass for displaying the filling level
D Red LED Delivery Low
F Display panel
E Yellow LED Fill Up
G Button for suppressing the acoustic alarm for
2 minutes
F Yellow LED Battery
20
Audio paused 2 min
Instructions for Use D-Vapor/D-Vapor 3000
Page 21
System overview
Rear
H Identification plate with manufacturer and
model information and Serial Number
A
I
B
C
I
Window to allow light to get out to illuminate the
control dial and the inspection glass
D
E
H
F
004
G
A Locking lever on plug-in adapter
B Opening for Interlock locking device (illustrated:
Interlock 2)
C Slot for locking lever, so that the Vapor can only
be removed from the anesthesia workstation
when the control dial is in the T position.
D Window to read off Vapor View data
E Connector system
Plug-in adapter Auto Exclusion
D-Vapor 3000 is only available with this plug-in
adapter
F Cover for RS232 interface
G Power cable
Instructions for Use D-Vapor/D-Vapor 3000
21
Page 22
System overview
Abbreviations
Abbreviation Description
Abbreviation Description
®
Registered trademark
NMD
™
Trademark
°C
Degree Celsius, unit of
temperature
Narkomed
(Name for anesthesia equipment
from Draeger Medical, Inc., USA,
previously North American Dräger)
°F
Degree Fahrenheit, unit of
temperature
O2
Medical oxygen
Pa
Air
Medical compressed air
Pascal (1 mbar = 100 Pa or 1 hPa),
unit of pressure
ASTM
American Society for Testing and
Materials
PEIRP
Equivalent isotropic transmission
power of the adjacent radio
equipment
cmH2O
Pressure unit
(1 cmH2O = ca.1 mbar)
psi
Pound force per square inch, unit of
pressure
CO2
Medical carbon dioxide
rel. %.
Relative deviation from value in %
CSA
Canadian Standards Association
VAH
EN
European standard
ft
Foot, unit of length
Verbund für Angewandte
Hygiene e.V. (Association for
applied hygiene)
hPa
Hectopascal (1 mbar = 100 Pa or
1 hPa), unit of pressure
Vol.
Volume
Vol.%
IEC
International Electrotechnical
Commission, organization for
international standards
Percentage by volume of
anesthetic agent in fresh gas at
Vapor outlet. Unit of dosing
VT
Tidal volume
in
Inch, unit of length
ISO
International Organization for
Standardization
kg
Kilogram, unit of mass
kPa
Kilopascal, unit of pressure
lbs
Pound, unit of mass
m
Meter, unit of length
MAC
Minimum Alveolar Concentration
mL
Milliliter, unit of volume
mm
Millimeter, unit of length
MRI
Magnetic resonance imaging
MV
Minute volume
N2O
Medical nitrous oxide
22
Instructions for Use D-Vapor/D-Vapor 3000
Page 23
System overview
Symbols
Symbol
Description
Symbol
Description
Observe the Instructions for
Use
Vol.%
Volume percent, indicates
concentration unit
Operating Instructions
Read
Instructions
Caution! Observe
accompanying documents
Audio paused Suppress audible alarm for
2 min
2 minutes
Caution! Observe
accompanying documents
Information for disposal
Warning! Strictly follow these
Instructions for Use.
Fuse
Connection for potential
equalization
Alternating current
Caution!
2; 3; 4;...
12 14 16 18
Concentration scale on the
control dial of the Vapor for
values up to and including
10 Vol.%.
0
Serial Number
SN
Manufacturer
Concentration numbers on the
Vapor control dial indicating the
dangers of a high output
concentration and a restricted
flow range
On rear of the Vapor and on the
connector, indicates flow
direction of the Vapor
Part number
REF
20xx
Date of manufacture
Marking in accordance with
Directive 93/42/EEC
concerning Medical Devices
IPX1
Level of protection from ingress
of water
On the pushbutton for locking
the control dial.
Control dial position 0 (zero
setting), see page 28
T
Des.
Control dial position T
(transport setting), see page 28
On control dial
Abbreviation of the anesthetic
agent for which the Vapor is
specified and calibrated
min.
Minimum permissible filling
level on the sight glass
max.
Maximum permissible filling
level on the sight glass
Vol.
Volume
Instructions for Use D-Vapor/D-Vapor 3000
23
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24
Instructions for Use D-Vapor/D-Vapor 3000
Page 25
Operating Concept
Operating Concept
Operating states . . . . . . . . . . . . . . . . . . . . . . . 26
Vapor off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Self test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vapor warming up. . . . . . . . . . . . . . . . . . . . . . .
Vapor ready . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vapor dosing. . . . . . . . . . . . . . . . . . . . . . . . . . .
26
26
26
27
27
Control dial . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Control dial position ON – switching on and
adjusting the concentration. . . . . . . . . . . . . . . . 27
Control dial position 0 – switching off . . . . . . . . 28
Control dial position T – transport setting . . . . . 28
Connection and Interlock systems for
D-Vapor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Plug-in adapter / plug-in connector. . . . . . . . . .
DW-2000 plug-in adapter with Interlock 2 . . . .
Plug-in adapter Dräger Auto Exclusion . . . . . .
S-2000 plug-in adapter with Interlock S . . . . . .
Permanent connection . . . . . . . . . . . . . . . . . . .
Conical connector 23 mm (0.91 in). . . . . . . . . .
29
30
30
31
31
32
Connection and Interlock systems for
D-Vapor 3000. . . . . . . . . . . . . . . . . . . . . . . . . . 32
Filling systems . . . . . . . . . . . . . . . . . . . . . . . . 33
Baxter filling system for Suprane
(desflurane) . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Desflurane Piramal Fill filling system . . . . . . . . 33
Sight glass . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Position of the user . . . . . . . . . . . . . . . . . . . . 34
Instructions for Use D-Vapor/D-Vapor 3000
25