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Instructions for use

PulmoVista 500

WARNING Electrical impedance tomograph


To properly use this medical device,
read and comply with these Software 1.3n
instructions for use.
Information about this document

Typographical conventions

1 Consecutive numbers indicate steps of action, Any text shown on the screen and any labeling on
with the numbering restarting with "1" for each the device are printed in bold and italics, e.g., ROI 1
new sequence of actions. or Ref.

 Bullet points indicate individual actions or differ- The "greater than" symbol > indicates the
ent options for action. navigation path in a dialog window, for example
System setup > System > Country. In this
– Dashes indicate the listing of data, options, or example, System setup represents the dialog
objects. window title, System represents a horizontally
(A) Letters in parentheses refer to elements in the aligned tab, and Country a vertically aligned tab.
related illustration.
A Letters in illustrations denote elements referred
to in the text. Screen reproduction

The reproductions of screen content in the


instructions for use can differ from the content
actually shown on the screen.

Trademarks

Trademarks owned by Dräger Trademarks owned by third-party


manufacturers
Trademark
Medical Cockpit® Trademark Trademark owner
®
Infinity® Dismozon BODE Chemie

PulmoVista® Mikrobac®

MEDIBUS® acryl-des® Schülke & Mayr


®
MEDIBUS.X® Mikrozid
Perform®
The following web page provides a list of the Actichlor® Ecolab USA
countries in which the trademarks are registered: ®
www.draeger.com/trademarks Incidin
Oxycide®

2 Instructions for use PulmoVista 500 SW 1.3n


Trademark Trademark owner
BruTab 6S® Brulin
Dispatch® Clorox
®
Klorsept Medentech
®
Descogen Antiseptica
Oxygenon®
SteriMax® Aseptix
®
Cleanisept Dr. Schumacher

Safety information definitions

WARNING
A WARNING statement provides important in-
formation about a potentially hazardous situa-
tion which, if not avoided, could result in
death or serious injury.

CAUTION
A CAUTION statement provides important infor-
mation about a potentially hazardous situation
which, if not avoided, may result in minor or mod-
erate 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.

Instructions for use PulmoVista 500 SW 1.3n 3


User group requirements

The term "user group" describes the personnel User groups


responsible who have been assigned by the
operating organization to perform a particular task
on a product. Clinical users
This user group operates the product in
accordance with the intended use.
Duties of the operating organization
Users have medical specialist knowledge in the
application of the product.
The operating organization must ensure the
following:
Reprocessing personnel
– Every user group has the required qualifications
(e.g., has undergone specialist training or This user group carries out the necessary activities
acquired specialist knowledge through to reprocess the product.
experience).
Reprocessing personnel has specialist knowledge
– Every user group has been trained to perform in the reprocessing of medical devices.
the task.
– Every user group has read and understood the Service personnel
relevant chapters in this document.
This user group installs the product and performs
the service activities.
Service personnel has specialist knowledge in
electrical and mechanical engineering and
experience in the servicing of medical devices.
Where product-specific knowledge or tools are
required, the service activities must be carried out
by specialized service personnel. The specialized
service personnel was trained by Dräger for these
service activities on this product.

Abbreviations and symbols

For explanations refer to sections "Abbreviations"


and "Symbols" in chapter "Overview".

4 Instructions for use PulmoVista 500 SW 1.3n


Contents

Contents

Information about this document . . . . . . . . . 2 Getting started. . . . . . . . . . . . . . . . . . . . . . . . 49


Switching on PulmoVista 500 . . . . . . . . . . . . . 50
For your safety and that of your patients. . . 7
Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 51
General safety information . . . . . . . . . . . . . . . . 8 Attaching the patient interface. . . . . . . . . . . . . 53
Product-specific safety information. . . . . . . . . . 11 Connecting the trunk cable . . . . . . . . . . . . . . . 59
Monitoring sessions. . . . . . . . . . . . . . . . . . . . . 59
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Safety information for operation . . . . . . . . . . . 62
Contraindications . . . . . . . . . . . . . . . . . . . . . . . 17 Starting a new measurement . . . . . . . . . . . . . 63
Environments of use. . . . . . . . . . . . . . . . . . . . . 18 Main view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Other views . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Freeze display . . . . . . . . . . . . . . . . . . . . . . . . . 82
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Export screenshot . . . . . . . . . . . . . . . . . . . . . . 82
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 20 Marking events . . . . . . . . . . . . . . . . . . . . . . . . 82
Medical Cockpit (Infinity C500). . . . . . . . . . . . . 21 Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . . 84
EIT module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 86
Power supply module (Infinity P2500) . . . . . . . 24 Additional functions provided by the
Patient interface . . . . . . . . . . . . . . . . . . . . . . . . 25 option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Ending operation . . . . . . . . . . . . . . . . . . . . . . . 91
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 93
Operating concept . . . . . . . . . . . . . . . . . . . . . 35 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Hardware elements . . . . . . . . . . . . . . . . . . . . . 36 Configuring the screen layout . . . . . . . . . . . . . 94
Screen elements. . . . . . . . . . . . . . . . . . . . . . . . 38 Configuring EIT settings . . . . . . . . . . . . . . . . . 100
Configuring the system . . . . . . . . . . . . . . . . . . 102
Assembly and preparation . . . . . . . . . . . . . . 41 Configuring data recording . . . . . . . . . . . . . . . 106
Safety information for assembly and
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 109
preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Preparing the Cockpit . . . . . . . . . . . . . . . . . . . . 42 Message – Cause – Remedy . . . . . . . . . . . . . 110
Connecting the mains power supply. . . . . . . . . 43
Using the trolley . . . . . . . . . . . . . . . . . . . . . . . . 44 Reprocessing. . . . . . . . . . . . . . . . . . . . . . . . . 117
Intrahospital transport . . . . . . . . . . . . . . . . . . . 45 Safety information . . . . . . . . . . . . . . . . . . . . . . 118
Preparation for using the MEDIBUS or Information on reprocessing . . . . . . . . . . . . . . 119
MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . . 46 Classifications for reprocessing. . . . . . . . . . . . 119
Preparing the PressurePod . . . . . . . . . . . . . . . 47 Before reprocessing . . . . . . . . . . . . . . . . . . . . 120
Position of the user. . . . . . . . . . . . . . . . . . . . . . 48 Validated reprocessing procedures . . . . . . . . . 121
Other agents and reprocessing
procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
After reprocessing . . . . . . . . . . . . . . . . . . . . . . 125

Instructions for use PulmoVista 500 SW 1.3n 5


Contents

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Preventive maintenance. . . . . . . . . . . . . . . . . . 130
Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Disposal of the medical device. . . . . . . . . . . . . 132
Disposal of batteries. . . . . . . . . . . . . . . . . . . . . 132

Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 133


Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 134
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Performance characteristics . . . . . . . . . . . . . . . 134
Operating data . . . . . . . . . . . . . . . . . . . . . . . . . 135
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Communication interfaces on Medical
Cockpit Infinity C500 . . . . . . . . . . . . . . . . . . . . 137
Device combinations . . . . . . . . . . . . . . . . . . . . 137
EMC declaration. . . . . . . . . . . . . . . . . . . . . . . . 137
Connections to IT networks . . . . . . . . . . . . . . . 139

Principles of operation . . . . . . . . . . . . . . . . . 141


Image generation . . . . . . . . . . . . . . . . . . . . . . . 142
Information displayed by PulmoVista 500 . . . . 152
Definition of baseline frames . . . . . . . . . . . . . . 159
Definitions for color scales and scales of
impedance waveforms . . . . . . . . . . . . . . . . . . . 162
Principles of breath detection and
determination of the tidal rate. . . . . . . . . . . . . . 164
Pressure measurements with the
PressurePod and derived parameters . . . . . . . 165
Literature references . . . . . . . . . . . . . . . . . . . . 167

List of accessories . . . . . . . . . . . . . . . . . . . . . 169

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

6 Instructions for use PulmoVista 500 SW 1.3n


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
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connected devices . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Electromagnetic compatibility (EMC) . . . . . . . . 10
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Storing the instructions for use . . . . . . . . . . . . . 10
Mandatory reporting of adverse events . . . . . . 10

Product-specific safety information . . . . . . . 11


Essential performance . . . . . . . . . . . . . . . . . . . 13

Instructions for use PulmoVista 500 SW 1.3n 7


For your safety and that of your patients

General safety information

The following WARNING and CAUTION Service


statements apply to general operation of the
medical device.
WARNING
WARNING and CAUTION statements specific to Risk of medical device failure and of patient
subsystems or particular features of the medical injury
device appear in the respective sections of these
instructions for use or in the instructions for use of The medical device must be inspected and
another product being used with this medical serviced regularly by service personnel and
device. specialized service personnel. Repair and
complex maintenance carried out on the med-
ical device must be performed by specialized
Strictly follow these instructions for use service personnel.
If the above is not complied with, medical de-
WARNING vice failure and patient injury may occur. Ob-
serve chapter "Service".
Risk of incorrect operation and of incorrect
use Dräger recommends that a service contract is
obtained with DrägerService and that all re-
Any use of the medical device requires full un-
pairs are performed by DrägerService. For
derstanding and strict observation of all sec-
maintenance Dräger recommends the use of
tions of these instructions for use. The medi-
authentic Dräger repair parts.
cal device must only be used for the purpose
specified under "Intended use" on page 16.
Strictly observe all WARNING and CAUTION Accessories
statements throughout these instructions for
use and all statements on medical device la-
WARNING
bels. Failure to observe these safety informa-
tion statements constitutes a use of the medi- Risk due to incompatible accessories
cal device that is inconsistent with its intend- The use of incompatible accessories may ad-
ed use. versely affect the functional integrity of the
product. Personal injury and property damage
may occur as a consequence.
Use only compatible accessories. The acces-
sories that are compatible with this product
are listed in the list of accessories supplied
with the product.

For more information, see "List of accessories"


on page 169.

8 Instructions for use PulmoVista 500 SW 1.3n


For your safety and that of your patients

Connected devices

WARNING
Risk of electric shock and of device malfunc-
tion
Any connected devices or device combina-
tions not complying with the requirements
mentioned in these instructions for use can
compromise the correct functioning of the
medical device and lead to an electric shock.
Before operating the medical device, strictly
comply with the instructions for use of all con-
nected devices or device combinations.

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 persons familiar with the most
important inherent characteristics of the medical
device.
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 any
information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.

Instructions for use PulmoVista 500 SW 1.3n 9


For your safety and that of your patients

Electromagnetic compatibility (EMC) WARNING


Risk due to electromagnetic disturbance
Medical electrical equipment is subject to special
precautionary measures concerning Wireless communication devices (e.g., cellu-
electromagnetic compatibility. During installation lar phones) and medical electrical equipment
and before initial operation, follow the information in (e.g., defibrillators, electrosurgical devices)
section: EMC declaration (page 137). emit electromagnetic radiation. When such
devices are operated too close to this device
This device can be affected by other electrical
or its cables, the functional integrity of this de-
devices.
vice may be compromised by electromagnetic
disturbances. As a result, the patient could be
WARNING
put at risk.
Risk due to electrostatic discharge
Maintain a distance of at least 0.3 m (1.0 ft) be-
Malfunctions that endanger the patient may tween this device and wireless communica-
occur if no protective measures against elec- tion devices, to ensure that the essential per-
trostatic discharge are employed in the follow- formance of this device is fulfilled.
ing situations:
– When touching the pins of connectors that Maintain an adequate distance between this
carry the ESD warning symbol. device and other medical electrical equip-
– When establishing connections with these ment.
connectors.
To prevent malfunctions, observe the follow-
Training
ing measures and train the relevant person-
nel:
Training for users is available from the Dräger
– Observe the ESD protective measures.
organization responsible (see www.draeger.com).
Such measures may include wearing anti-
static clothing and shoes, touching a po-
tential equalization pin before and while
making the connection, or using electrical-
Storing the instructions for use
ly insulating and antistatic gloves.
– Observe the requirements for the electro- CAUTION
magnetic environment. Observe the fol- Risk of incorrect use
lowing section: "Electromagnetic environ-
Instructions for use must be kept accessible to the
ment" (page 138).
user.

Mandatory reporting of adverse events

Serious adverse events with this product must be


reported to Dräger and the responsible authorities.

10 Instructions for use PulmoVista 500 SW 1.3n


For your safety and that of your patients

Product-specific safety information

WARNING WARNING
To properly use this medical device, the user Risk of electric shock and of device malfunc-
must obtain a full understanding of the perfor- tion
mance characteristics of this medical device
Do not use the medical device in environ-
prior to use by carefully reading these Instruc-
ments that are subject to conductive pollu-
tions for Use.
tion, e.g., metal or graphite particles or dust,
or continuous conductivity, e.g., wet condi-
WARNING tions.
Risk of incorrect use
This medical device must only be used by WARNING
physicians, respiratory therapists, and nurs- Risk of fire and of explosion
es, who have received training on the use of
PulmoVista 500 is not intended to be used in
this medical device.
areas with explosion hazards and in the pres-
ence of flammable anesthetic agents or other
WARNING flammable agents.
Risk of wrong therapeutic decisions
Do not use this medical device as the sole ba- WARNING
sis for diagnosis or therapeutic decisions. Risk of fire
Do not use the medical device in an oxygen-
WARNING enriched environment.
Risk of personal injury
Modifications to the medical device may WARNING
cause malfunctioning. Risk of fire
Do not modify this medical device without au- Do not position the medical device close to an
thorization by Dräger. oxygen outlet which opens to the ambient at-
mosphere. Keep the medical device at least
WARNING 1 m (3.3 ft) in front of the O2 outlet and 20 cm
(7.9 in) to the side of the O2 outlet.
Risk of ineffective defibrillation
Remove all parts of the patient interface from WARNING
the patient before cardiac defibrillation.
Risk of device malfunction

WARNING Do not use the medical device outside the


specified ambient conditions.
Risk of device malfunction
If the patient interface was connected during
defibrillation despite the warning, all parts of
the patient interface, including the patient ca-
ble and the trunk cable, must be replaced.

Instructions for use PulmoVista 500 SW 1.3n 11


For your safety and that of your patients

WARNING WARNING
Risk due to penetrating liquid Risk of device malfunction
Penetrating liquid may cause the following: If the ventilation slots or heat exchange sur-
– Damage to the device faces of the medical device are covered, the
– Electric shock air flow is blocked and the medical device may
– Device malfunctions overheat.

Ensure that no liquid penetrates the device. Do not cover the ventilation slots and heat ex-
change surfaces of the medical device.
WARNING
Risk of electric shock and of device malfunc- WARNING
tion Risk of electric shock

Penetrating liquid may cause malfunction of Do not open the housing of the medical de-
or damage to the device, which may endanger vice.
the patient.
Do not immerse or rinse the EIT system or its WARNING
components (e.g., patient interface, Cockpit, Risk of electric shock and of device malfunc-
cables, USB storage media) in liquids. During tion
surface disinfection make sure that no liquids Only connect passive storage media without
enter the device. their own power supply to the USB port.
If a liquid is accidentally spilled on the device,
disconnect the device from the power source. WARNING
Contact service personnel regarding the con- Risk of electric shock and of device malfunc-
tinued safety of the device before putting it tion
back into operation.
Do not use the medical device in areas outside
the specification for electrical supply as stat-
WARNING
ed in the section "Operating data"
Risk of device malfunction on page 135.
Do not expose the medical device to direct ra-
dioactive radiation. WARNING
Risk of device malfunction
WARNING
Do not use the medical device in the presence
Risk of device malfunction of strong magnetic fields, e.g., MRI.
Do not directly expose any part of the medical
device, except the patient interface, to X-rays. WARNING
Risk of skin burns
Disconnect the electrode belt from the device
or from the patient during electricity-based
therapies such as electrosurgery or electro-
cautery.

12 Instructions for use PulmoVista 500 SW 1.3n


For your safety and that of your patients

WARNING Essential performance


Risk of patient contamination
PulmoVista 500 displays EIT dynamic images and
Do not attach the electrode belt to the sterile changes of the end-expiratory lung impedance in a
part of the patient’s body where surgery is be- way which allows the informed user to interpret the
ing performed. displayed information correctly.
PulmoVista 500 ensures that the currents passed
CAUTION to the patient are within acceptable limits.
X-rays can impair the quality of EIT images.
PulmoVista 500 is not a life-supporting device in the
Only operate the medical device at a distance of sense of IEC 60601-1-2.
at least 1.5 m (4.9 ft) from X-ray devices.

CAUTION
Risk of damage to the touchscreen
Do not allow sharp instruments to touch the touch-
screen of the Medical Cockpit (Infinity C500).

CAUTION
Risk of overheating
Keep the medical device away from sources of
heat such as direct sunlight or radiators. Do not
cover the device with bedclothes.

CAUTION
Risk of wrong therapeutic decisions
Check if ECG, EMG, EOG or EEG are influenced
by EIT measurements.

CAUTION
Risk due to missing anti-virus software
PulmoVista 500 does not include any anti-virus
software and thus relies on the anti-virus mea-
sures of the hospital.

The Medical Cockpit (Infinity C500) is only


designed for use with the software supplied with
PulmoVista 500. Software updates must be
performed by specialized service personnel.

Instructions for use PulmoVista 500 SW 1.3n 13


This page has been left blank intentionally.

14 Instructions for use PulmoVista 500 SW 1.3n


Application

Application

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Contraindications . . . . . . . . . . . . . . . . . . . . . . 17

Environments of use . . . . . . . . . . . . . . . . . . . 18

Option ADAP. . . . . . . . . . . . . . . . . . . . . . . . . . 18

Instructions for use PulmoVista 500SW 1.3n 15


Application

Intended use

PulmoVista 500 is a monitoring device that


provides global and regional information on the
lung function of the patient.
PulmoVista 500 performs thoracic impedance
measurements.
The information displayed serves as a supplement
to other clinical information to assist the user in
assessing changes in air content within a patient's
thoracic cross-section.
PulmoVista 500 is intended for use on patients for
whom a suitable patient interface is available.

Indications

PulmoVista 500 is intended for use on adult and


pediatric patients whose regional distribution of
ventilation and of lung volume are of clinical
interest. To ensure proper contact between the
electrodes and the skin during the measurements,
patients must be in a supine, prone, or lateral
position. In a seated position, the patient must lean
against a backrest.

16 Instructions for use PulmoVista 500SW 1.3n


Application

Contraindications

WARNING
Risk of pacemaker impairment
Do not use PulmoVista 500 on patients with
pacemaker.

WARNING
Risk of defibrillator impairment
Do not use PulmoVista 500 on patients with an
implantable cardioverter-defibrillator.

WARNING
Risk of excessive skin damage
Do not use PulmoVista 500 on patients whose
skin is damaged in the region where the pa-
tient interface needs to be placed.

WARNING
Do not use PulmoVista 500 on patients where
the attachment of the patient interface could
pose a risk to the patient, e.g., patients with
spinal lesions or fractures.

WARNING
Information on the safe and effective use of
the device on pregnant women is not yet avail-
able.
Do not use PulmoVista 500 on these patients.

WARNING
Information on the safe and effective use of
the device on premature babies is not yet
available.
Do not use PulmoVista 500 on these patients.

NOTE
Measurement accuracy for pediatric patients with
a tidal volume less than 20 mL was not validated.
Measurement accuracy for adult patients with a
tidal volume less than 50 mL was not validated.

Instructions for use PulmoVista 500SW 1.3n 17


Application

Environments of use

PulmoVista 500 is intended for use in hospital PulmoVista 500 must not be used:
environments only. – During transport
– In areas of explosion hazard
When switched off and disconnected from the
– In oxygen-rich environments
patient, PulmoVista 500 may accompany a patient
– In areas where radioactive substances are used
during transport within the hospital.
The use in computed tomography examination labs WARNING
is possible, but this may result in impaired EIT data. Risk of fire and of explosion
The use in operating rooms is possible, but PulmoVista 500 is not intended to be used in
requires special safety measures regarding sterile areas with explosion hazards and in the pres-
surgery areas and electrosurgical treatment. For ence of flammable anesthetic agents or other
further information, see the following section: flammable agents.
"Product-specific safety information" on page 11.

Option ADAP

The option ADAP (Advanced Data Analysis


Package) extends the functionality of the basic EIT
software with the following functions:
– Patient data entry
– Data recording
– Data review
– File handling
– Higher frame rate
– Filter setting Band pass
– Manual adjustment of the operating frequency
For a detailed description, refer to "Additional
functions provided by the option ADAP"
on page 87.

18 Instructions for use PulmoVista 500SW 1.3n


Overview

Overview

PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 20

Medical Cockpit (Infinity C500) . . . . . . . . . . . 21


Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

EIT module . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Right side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Underside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Power supply module (Infinity P2500) . . . . . 24


Underside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Patient interface . . . . . . . . . . . . . . . . . . . . . . . 25
Electrode belt for adults . . . . . . . . . . . . . . . . . . 25
Patient cable for adults . . . . . . . . . . . . . . . . . . . 26
Electrode belt for pediatric patients . . . . . . . . . 27
Patient cable for pediatric patients . . . . . . . . . . 28
Trunk cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 29
Abbreviations in the PulmoVista 500
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Abbreviations in these instructions for use . . . . 30
Abbreviations for labeling . . . . . . . . . . . . . . . . . 31

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Instructions for use PulmoVista 500 SW 1.3n 19


Overview

PulmoVista 500

The electrical impedance tomograph


PulmoVista 500 consists of the following
components:

F
A

G
B

C E

D H

010a

A Medical Cockpit (Infinity C500)


B Handle
C EIT module
D Trolley with 4 double castors with locking
brakes
E Power supply module (Infinity P2500)
F Electrode belt
G Patient cable
H Trunk cable

20 Instructions for use PulmoVista 500 SW 1.3n


Overview

Medical Cockpit (Infinity C500)

The Medical Cockpit, hereafter referred to as


Cockpit, is the user interface for PulmoVista 500.
The Cockpit displays images, waveforms, and
parameters originating from the EIT module or from
a Dräger device connected via MEDIBUS or
MEDIBUS.X.

Front

Infinity C500 (MS18746): A Alert bar, lights up red during system start, not
otherwise used

A B Audio pause button (only active during screen


calibration)
C Rotary knob
D Battery LED, indicates battery status
E On/Off key
F Mains power LED, lights up when the device is
connected to AC power
B
FE D C
002

Infinity C500 (MK31500):

B
EF D C
134

Instructions for use PulmoVista 500 SW 1.3n 21


Overview

Back

Infinity C500 (MS18746):

A
B
C C

D
012

Infinity C500 (MK31500):

C C

D
135

A Cockpit holder
B Cover with opening for system cable
C USB ports (right and left)
D Serial communication ports (RS 232)

22 Instructions for use PulmoVista 500 SW 1.3n


Overview

EIT module

Right side Front

D
B A

C
D

F
015

020
A Trunk cable port
F Securing bracket for system cable plug
B Label for trunk cable port
C Test connector
Back
D Label for test connector

Underside
G

E G
019

E System cable port, for connection to power


supply
137

G Ventilation slots

Instructions for use PulmoVista 500 SW 1.3n 23


Overview

Power supply module (Infinity P2500)

Underside

A B C D

014b

A System cable port, for connection to EIT


module
B System cable port, for connection to Cockpit
C Potential equalization connector
D Power cord connection

Front

The front of the power supply module has two


LEDs.

LED Color Symbol Meaning Status Description


Green AC power Unlit Mains power supply not available
Lit Mains power supply available, bat-
tery charging in progress
Yellow ! Battery failure Unlit Battery working correctly
indicator Lit Battery failure

If the power supply module has been disconnected


from the mains power supply for several minutes,
the yellow LED will briefly light up when the power
supply module is again connected to the mains
power supply.
The battery is being charged if the green LED is lit
and the yellow LED is not lit.

24 Instructions for use PulmoVista 500 SW 1.3n


Overview

Patient interface

The patient interface is made up of the following PulmoVista 500 is intended for use on patients with
components: a chest circumference of 36 cm (14.2 in) to 150 cm
– Electrode belt for adults (sizes S-XXL) or (59 in).
pediatric patients (sizes 4XS-XS)
The electrode belt and the patient cable are
– Reference electrode
available in different versions for adults and
– Patient cable (for adults or pediatric patients)
pediatric patients.
– Trunk cable

Electrode belt for adults

The electrode belt has 16 equally spaced Interior surface


electrodes and a closure stud. Electrode studs 1
and 16 are numbered.
The electrode belt is available in 5 sizes that can
easily be identified by different colors and a size
E F E
label. See page 54.

Exterior surface

022
E Electrodes, 1 to 16
A B C B D
F Midposition marker
1 16

L L
021

A Closure with 6 different positions


Position 3 from the right provides optimal
reconstruction of the EIT images.
B Electrode studs, 1 to 16
C Size label
D Closure stud

Instructions for use PulmoVista 500 SW 1.3n 25


Overview

Patient cable for adults

NOTE
The patient cable is specifically designed for the
detection of very low voltages. Since the patient
cable is very complex, it is very sensitive and must
be handled with care. Do not bend, pull or twist the
cable.

The patient cable has 16 equally spaced serially


numbered snaps to connect to the electrode studs
on the electrode belt. One end of the patient cable
has a reference electrode snap. The other end of
the patient cable terminates with a snap for the
closure stud of the electrode belt.
The patient cable is available in 5 sizes,
corresponding to each electrode belt size. The
snaps on the patient cable are color-coded to
match the corresponding electrode belt.
Color coding of the electrode snaps of the various
patient cables:

Size Color
S Medium blue
M Dark blue
L Dark red
XL Gray
XXL Violet

A
С 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 R

L R
E D C B
028

A 16 electrode snaps
B Reference electrode snap, labeled Ref
C Right patient cable port, green colored, labeled R
D Left patient cable port, red colored, labeled L
E Closure snap, labeled C

26 Instructions for use PulmoVista 500 SW 1.3n


Overview

Electrode belt for pediatric patients

The electrode belt has 16 equally spaced Interior surface


electrodes and no closure stud. Electrode studs
Sizes XS and 2XS:
1 and 15 are numbered.
The electrode belt is available in 4 sizes (XS-4XS)
that can easily be identified by different colors and H H
a size label. See page 54.

Exterior surface

046
Sizes XS and 2XS:
Sizes 3XS and 4XS:
A B C B
1 XS 15
H F H
58 - 72 cm 22.8 - 28.3“

D E
044

047
Sizes 3XS and 4XS:
H Electrodes, 1 to 16
A BC F B
1 4XS 15

36 - 44 cm 14,2 - 17,3“

D E G
045

A Closure with 5 different positions


Position 3 provides optimal reconstruction of
the EIT images.
B Electrode studs, 1 to 16
C Size label
D Information on chest circumference
E Midposition marker
F Cut-outs for the armpits (only available for sizes
3XS and 4XS)
G Symbol for infant; shows the correct
orientation of the electrode belt on the patient
(only available for sizes 3XS and 4XS)

Instructions for use PulmoVista 500 SW 1.3n 27


Overview

Patient cable for pediatric patients Trunk cable

NOTE
The patient cable is specifically designed for the A
detection of very low voltages. Since the patient
cable is very complex, it is very sensitive and must
be handled with care. Do not bend, pull or twist the
cable.

The patient cable has 16 equally spaced serially


numbered snaps to connect to the electrode studs B

R
on the electrode belt. The end of the patient cable
next to electrode snap 16 is equipped with a
reference electrode snap. The other end of the C
patient cable terminates with the snap for L

016
electrode 1 because the patient cable does not
A Trunk cable plug
have a closure snap.
B Right patient cable plug, green colored, labeled R
The patient cable is available in one size and is
marked with the compatible sizes of the electrode C Left patient cable plug, red colored, labeled L
belt (XS-4XS). The patient cable can be attached to
all electrode belts for pediatric patients.

A
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 R

L R B
D C
048

A 16 electrode snaps
B Reference electrode snap, labeled Ref
C Right patient cable port, green colored, labeled R
D Left patient cable port, red colored, labeled L
Color coding of the electrode snaps of the patient
cables:

Size Color
XS-4XS White

28 Instructions for use PulmoVista 500 SW 1.3n


Overview

Abbreviations

Abbreviations in the PulmoVista 500 software

Abbreviation Explanation Abbreviation Explanation


/min Per minute EELI win [%] End-expiratory lung impedance
ADAP Advanced Data Analysis Pack- win
age EEPes End-expiratory esophageal
C Cursor C pressure

C loss [%] Compliance Loss (decrease in EEPga End-expiratory gastric pressure


compliance) EEPtp End-expiratory transpulmonary
C loss HP [%] Compliance loss towards high- pressure
er PEEP levels (decrease in EIP End-inspiratory pressure
compliance with increasing EIPes End-inspiratory esophageal
PEEP levels) pressure
C loss LP [%] Compliance loss towards lower EIPtp End-inspiratory transpulmonary
PEEP levels (decrease in com- pressure
pliance with decreasing PEEP
levels) EL Lung elastance

C win [%] Compliance win (increase in Ers Respiratory system elastance


compliance) IP address Internet protocol adress
Ccw Chest wall compliance kHz Kilohertz
CL Lung compliance mbar Millibar
cmH2O Centimeters of water min Minute
1 cmH2O = approx. 1 mbar
mL Milliliter
Crs Respiratory system compliance
mmHg Millimeters of mercury
dB Decibel
MTV global Global minute tidal variation
EELI global Global change of end-expirato-
MTV ROI Regional minute tidal variation
ry lung impedance
Paw Airway pressure
Paw Airway driving pressure
Pdi Transdiaphragmatic pressure
Pes Esophageal driving pressure
PEEP Positive end-expiratory pres-
Ptp Transpulmonary driving pres-
sure
sure
Pga Gastric pressure
∆EELI ROI Regional change of end-expira-
tory lung impedance PIP Peak inspiratory pressure
Ecw Chest wall elastance PTPdi Pressure-time product of the
transdiaphragmatic pressure
EELI loss [%] End-expiratory lung impedance
loss

Instructions for use PulmoVista 500 SW 1.3n 29


Overview

Abbreviation Explanation Abbreviation Explanation


PTPes Pressure-time product of the TV ROI Regional tidal variation
esophageal pressure Vol. Volume
Ref Cursor Ref VT Tidal volume
Ref Reference
MEDIBUS abbreviations can be found in the
ROI Region of interest
document "MEDIBUS for V and VN ventilators"
RVD Regional ventilation delay (re- (9039527).
gional delay during ventilation)
MEDIBUS.X abbreviations can be found in the
RVD Ratio Ratio of the RVD pixels to the document "Profile Definition MEDIBUS.X"
total number of ventilated pixels (9052608).
RVD SD RVD standard deviation (stan- Additional MEDIBUS data abbreviations:
dard deviation of the RVD)
s Second Abbreviation Explanation
Ti Inspiratory time I:E Ratio of inspiratory time to expi-
ratory time
Tidal rate Tidal rate per minute
V Volume
Respiratory rate detected by
electrical impedance tomogra-
phy
TV global Global tidal variation

Abbreviations in these instructions for use

Abbreviation Explanation Abbreviation Explanation


A Ampere EEG Electroencephalogram
AC Alternating current EELI End-expiratory lung impedance
BF Body floating EIT Electrical impedance tomogra-
CISPR Comité international spécial phy
des perturbations radioélec- EMC Electromagnetic compatibility
triques (Special International EMG Electromyography
Committee on Radio Interfer-
ence) EOG Electrooculogram
cm Centimeter ESD Electrostatic discharge
COM1 Communication port 1 FEM Finite element method
CT Computer tomography GHz Gigahertz
DC Direct voltage Hz Hertz
ECG Electrocardiogram in Inch
LED Light-emitting diode

30 Instructions for use PulmoVista 500 SW 1.3n


Overview

Abbreviation Explanation
MB Megabyte
MEDIBUS Dräger communication protocol
for medical devices
MRI Magnetic resonance imaging
Rel. Relative
RF Radio frequency
SELV Safety extra low voltage
SIM Subscriber Identity Module
USB Universal serial bus
V Voltage

Abbreviations for labeling

Abbreviation Explanation
C Closure snap
IPX Degree of protection against in-
gress of water
L Left
Paux Auxiliary pressure
R Right
Ref Reference electrode snap

Instructions for use PulmoVista 500 SW 1.3n 31


Overview

Symbols

Symbol Explanation Symbol Explanation


On/Off key S Small

Mains power supply M Medium


(AC power) Large
L
Battery indicator
XL Extra large
The product is a medical device
(CE conformity assessment XXL Extra extra large
procedure)
XS Size label on the electrode belt
Caution! Observe important (for pediatric patients)
safety-relevant information and 2XS
precautionary measures in the
instructions for use. 3XS
Follow instructions for use.
4XS

ESD (electrostatic discharge) Symbol for infant


warning symbol Temperature during storage
Observe disposal instructions
Relative humidity during
storage
Applied part type BF
Ambient pressure during
storage
Manufacturer
System cable port for connec-
20xx Year of manufacture tion of the EIT module to the
Risk of medical device tipping power supply module
over when the medical device is EIT Trunk cable port for connection
pushed of the trunk cable to the EIT
Non-ionizing electromagnetic module
radiation TEST Test connectors
Protective earth China RoHS mark
Potential equalization
connector Connection for potential equal-
ization bonding at the bottom of
USB port the power supply unit
Serial connection Keep away from rain

SN Serial number Identification of packaging ma-


02

terial
REF Part number, sometimes
including revision index This end up

32 Instructions for use PulmoVista 500 SW 1.3n


Overview

Symbol Explanation
Non-stackable

Fragile

Use by

~ Waveform (symbol on the


screen)
Maximum weight
max. 44 kg (97 lbs)

Sys System connector at the


Con
Cockpit
Audio paused key (not used)

Instructions for use PulmoVista 500 SW 1.3n 33


This page has been left blank intentionally.

34 Instructions for use PulmoVista 500 SW 1.3n


Operating concept

Operating concept

Hardware elements. . . . . . . . . . . . . . . . . . . . . 36
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
LEDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Screen elements . . . . . . . . . . . . . . . . . . . . . . . 38
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Monitoring area. . . . . . . . . . . . . . . . . . . . . . . . . 38
Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 39
Dialog windows. . . . . . . . . . . . . . . . . . . . . . . . . 39
Button and tab colors . . . . . . . . . . . . . . . . . . . . 40
Calibrating the touchscreen . . . . . . . . . . . . . . . 40

Instructions for use PulmoVista 500 SW 1.3n 35


Operating concept

Hardware elements

Overview Rotary knob backlight


The backlight of the rotary knob lights up yellow
The Cockpit is the user interface for PulmoVista when an action is required to be confirmed by
500. This section describes its most important pressing the knob.
hardware elements.

Fixed keys
Rotary knob
Two fixed keys are located at the Cockpit. The
On/Off key (A) is located in the left corner. The
Audio Paused key (B) has no functionality.

A
027

Using the rotary knob A B


1 To select a setting, press a button on the 011

screen.
2 Turn the rotary knob clockwise to increase a
numeric value, scroll down a list or navigate to
the right during horizontal navigation.
Turn the rotary knob counterclockwise to
decrease a numerical value, scroll up a list or
navigate to the left during horizontal navigation.
3 Press the rotary knob to confirm a setting or to
activate a function when it appears yellow.

36 Instructions for use PulmoVista 500 SW 1.3n


Operating concept

LEDs

The Cockpit is equipped with several LEDs that A Mains power LED
report the device status.
B On/Off key and LED. The LED in the key lights
Infinity C500 (MS18746): up when the system is switched on
C Battery LED – indicates the battery status
D Ambient light sensor

A B C
003

Infinity C500 (MK31500):

DB A C
134

LED indications

LED Symbol LED Color/State Description


AC power Unlit No mains power supply available
Solid green Mains power supply available
Power Unlit System is switched off

Solid green System is switched on


Battery Unlit No battery power available
Solid green Battery capacity >80 %
Solid yellow Battery capacity 80 %
Flashes yellow Fault

Instructions for use PulmoVista 500 SW 1.3n 37


Operating concept

Screen elements

Overview E
A B C D
F

503
The following diagram describes the major screen
elements of the Cockpit as the user interface of A Patient ID (requires the option ADAP)
PulmoVista 500. Each element is described in more
detail in the following sections. B System time
C Filter settings
A
D Signal quality indicator
E Technical messages
F Help text messages

B
Monitoring area
C
The monitoring area consists of the area for images
and waveforms and the parameter boxes. The
appearance and the content of the monitoring area
can be adapted to the clinical situation with the use
502

of the Views... button, see page 64.


A Header bar
B Monitoring area
D
C Main menu bar A

C
Header bar B
The blue header bar is always visible and always
appears along the top of the Cockpit. The header
bar is divided into several fields which are reserved
for specific types of information. The fields that are
504

displayed are limited during Standby and may


change according to the installation of optional A Dynamic image
software.
B Status image
By touching different fields in the header, specific
dialog windows can be opened. C Impedance waveforms
D Parameter boxes for displaying the following:
– Tidal rate
– Tidal variation or minute tidal variation

38 Instructions for use PulmoVista 500 SW 1.3n


Operating concept

Main menu bar I Start/ Standby... for selecting standby mode or


starting the measurement, see "Standby mode"
The main menu bar is located along the right edge on page 86
of the screen and is always visible. It consists of the Touching a button opens the corresponding dialog
following buttons: window or activates the corresponding function.

A Dialog windows
B
C Dialog windows consist of one or more pages,
D
E which may in turn have subpages. Pages and
subpages are accessed by touching the
corresponding horizontal or vertical tab. Dialog
F windows contain elements for operating the system
and inform the user of current settings. Dialog
G windows can be opened by touching a button in the
H main menu bar.
I
502

A
A Views..., for accessing the predefined views B
– Main
– Full-screen image C C C C
– Ptp analysis
– End-insp. trend D
– EELI trend
– Diagnostics D
For details, see "Main view" on page 64. D
B Freeze display, see "Freeze display"
on page 82
C Export screenshot, see "Export screenshot"
on page 82
D Mark event..., see "Marking events"
on page 82
E Data review... (requires the ADAP option), see
"Data review" on page 87
505

F Record (requires the ADAP option), see "Data


recording" on page 87 A Dialog window title
G Signal check... for checking the electrode B Button for closing the dialog window
resistance, see "Signal quality" on page 84
C Horizontal tabs
H System setup... for configuring the system
D Vertical tabs
functions, see "Configuration" on page 93

Instructions for use PulmoVista 500 SW 1.3n 39


Operating concept

Button and tab colors Calibrating the touchscreen

Colors identify the availability of functions or If the touchscreen can no longer be operated, it
settings. might be maladjusted. In this case, calibrate the
touchscreen.
The colors listed in the following table indicate if a
button or a tab is available or selectable and if a NOTE
user action is required.
No screen content is displayed during touchscreen
Color Status calibration. Therefore, only calibrate the touch-
screen if no screen content needs to be displayed.
Light green The button is active, ready for se-
lection. 1 Press and hold the rotary knob and the key
Dark green The button has been selected simultaneously for at least 10 seconds.
and displays the current selec- The calibration screen is displayed.
tion.
2 Touch the markings displayed consecutively on
Yellow The button is selected. However, the touchscreen.
user input or confirmation by
pressing the rotary knob is re- Only for Infinity C500 (MS18746):
quired. 3 To confirm the calibration, touch the green tick.
Gray The button is not available for se-
lection due to a certain mode or
required connection.

If a selection is not confirmed within 15 seconds, it


will revert to the previous setting.

40 Instructions for use PulmoVista 500 SW 1.3n


Assembly and preparation

Assembly and preparation

Safety information for assembly and


preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Preparing the Cockpit . . . . . . . . . . . . . . . . . . 42


Tilting the Cockpit . . . . . . . . . . . . . . . . . . . . . . . 42
Turning the Cockpit . . . . . . . . . . . . . . . . . . . . . 42

Connecting the mains power supply . . . . . . 43

Using the trolley . . . . . . . . . . . . . . . . . . . . . . . 44


Parking the trolley. . . . . . . . . . . . . . . . . . . . . . . 44

Intrahospital transport . . . . . . . . . . . . . . . . . . 45
Before transportation . . . . . . . . . . . . . . . . . . . . 45
Moving the trolley . . . . . . . . . . . . . . . . . . . . . . . 45

Preparation for using the MEDIBUS or


MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . 46
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Connecting PulmoVista 500 to a Dräger
device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Preparing the PressurePod . . . . . . . . . . . . . . 47

Position of the user . . . . . . . . . . . . . . . . . . . . 48

Instructions for use PulmoVista 500 SW 1.3n 41


Assembly and preparation

Safety information for assembly and preparation

WARNING WARNING
Risk of personal injury Risk of device malfunction, of electric shock,
and of mechanical instability
Modifications to the medical device may
cause malfunctioning. If there are any signs of damage, do not use
PulmoVista 500.
Do not modify this medical device without au-
thorization by Dräger. Contact DrägerService.

Preparing the Cockpit

CAUTION Turning the Cockpit


Risk of damage to the Cockpit
The Cockpit can be turned 30° to the left or to the
Check that the Cockpit is fitted securely. right.
 Turn to the desired working position.
Tilting the Cockpit

The Cockpit can be tilted up and down.

B
043

1 Press and hold the tilt release button (A).


2 Tilt the Cockpit to the desired working position.
3 Release the button and make sure that it
engages securely.
Make sure that the Cockpit mount (B) is secure.

42 Instructions for use PulmoVista 500 SW 1.3n


Assembly and preparation

Connecting the mains power supply

WARNING NOTE
Risk of electric shock and of device malfunc- Only use the power supply cord supplied by
tion Dräger.
Do not use the medical device outside of a
hospital. NOTE
Position PulmoVista 500 so that its mains plug can
be pulled out for disconnection without difficulty.
WARNING
Risk of electric shock Make sure that the mains power supply is in
Only connect PulmoVista 500 to a mains pow- accordance with the specifications in the
er supply with protective grounding. "Operating data" section.
 Insert the mains plug into the mains power
WARNING outlet.
Risk of high leakage current The LED on the Cockpit and the LED on the
Wrong connections may jeopardize the elec- power supply module light up green.
trical safety of this device.
Only connect the mains plug to a fixed mains Power supply from the internal battery
power socket. The power supply module incorporates an internal
battery to ensure that operation of the device can
WARNING continue for at least 5 minutes without mains power
Risk of electric shock (if the battery is fully charged).

Wrong connections, e.g., to other equipment, When mains power is connected, the internal
may violate the insulation concept. battery is being charged. The internal battery will
only reach its full capacity after charging for
Do not disconnect the system cables. Contact 24 hours.
DrägerService if necessary.

Power supply for the Cockpit and the EIT


WARNING
module
Risk of explosion
The Cockpit and the EIT module are supplied with
The device must be located in a well-ventilat- power from the power supply module using two
ed area when connected to the mains power system cables. The system cables have already
supply. Electrolytic gas can occur when the been permanently installed.
batteries are charging. In a sufficient concen-
tration, this can cause an explosion.

NOTE
Keep PulmoVista 500 connected to the mains
power supply during storage to prevent battery de-
pletion.

Instructions for use PulmoVista 500 SW 1.3n 43


Assembly and preparation

Potential equalization
The power supply module contains a potential
equalization connector, which can be used in
specific cases for connections with other electrical
devices to ensure an equal ground potential. For
further details, refer to IEC 60601-1, or applicable
national or international standards.

Using the trolley

WARNING Parking the trolley


Risk of tipping over
CAUTION
Do not attach additional items to the trolley.
When parking the trolley, lock all double castors
and make sure that the brakes are working cor-
CAUTION rectly.
Risk of tipping over
Do not tilt the device more than 10°.

10°
033

 Check the correct condition of the trolley before


each use.
 Make sure that all device parts, e.g., Cockpit,
are securely attached.

44 Instructions for use PulmoVista 500 SW 1.3n


Assembly and preparation

Intrahospital transport

WARNING Moving the trolley


Risk of patient injury and risk of device dam-
1 Before moving the trolley, release all four
age
locking brakes.
During intrahospital transport a pulling force
2 To move the trolley, securely hold the trolley
may be exerted on the patient, the patient ca-
handle and move the device in the longitudinal
ble, and the electrode belt, e.g., if the patient
direction.
cable becomes caught on other objects.
3 During transportation across inclinations,
Disconnect the patient from the device. To do
around corners or across thresholds, (e.g., in
this, switch off the device and remove the pa-
doors or elevators) the medical device must not
tient cable from the trunk cable.
collide with any object.
During inter-clinical transport securely posi-
tion the parts remaining with the patient.

WARNING
Risk of personal injury and device damage
A toppling risk exists near thresholds, on un-
even ground and on ramps.
Move the trolley at a walking pace. Securely
hold the device using the handle when pass-
ing thresholds and obstacles.

Do not switch on PulmoVista 500 during


intrahospital transport.

Before transportation

1 Switch off PulmoVista 500 and remove the


mains plug from the mains power outlet.
2 Remove the patient cable plugs from the patient
cable ports.
3 Do not attach any additional parts to the handle.
4 Rotate the Cockpit to the central position.

Instructions for use PulmoVista 500 SW 1.3n 45


Assembly and preparation

Preparation for using the MEDIBUS or MEDIBUS.X protocol

Overview The MEDIBUS or MEDIBUS.X interface must only


be connected to the devices specified by Dräger by
PulmoVista 500 can display data from Dräger service personnel.
devices using the MEDIBUS- or MEDIBUS.X The following data can be displayed:
protocol.
– Volume waveform (Main view)
Only connect the following Dräger devices1) to the
COM 1 port of PulmoVista 500: – Tidal volume parameter (Main view)
– Atlan A300, A300 XL, A350, A350 XL – 3 configurable parameters, as defined in the
– Babylog VN500 system setup
– Babylog VN800 / VN600 (view End-insp. trend, EELI trend)
– Evita 2 dura
– Evita 4, Evita 4 edition – The parameters PEEP and EIP (or PIP if EIP is
– Evita Infinity V500 not available) in the Diagnostics view
– Evita V300 – All MEDIBUS parameters on the page Data
– Evita XL review
– Evita V800 / V600
– Perseus A500 The following MEDIBUS or MEDIBUS.X data is
– Primus recorded as part of data recording (requires the
– Savina 300 option ADAP):
– Zeus – All measured values
– 3 real-time waveforms
The devices listed for connection to the serial port
meet the requirements of IEC 60950-1 for
ungrounded SELV circuits or the requirements of
IEC 60601-1 (2nd edition and higher) for touchable
secondary circuits with max. 24 V DC nominal
voltage.

1 Not all products are commercially available worldwide.

46 Instructions for use PulmoVista 500 SW 1.3n


Assembly and preparation

Connecting PulmoVista 500 to a Dräger device

Prerequisite: PulmoVista 500 is in standby mode. Infinity C500 (MK31500):


Use the appropriate MEDIBUS cable (see "List of
accessories" on page 169) to connect PulmoVista
500 to the Dräger device in use.
Infinity C500 (MS18746):

B A

136
B
1 Insert the connector (A) into the COM 1 port (B)
at the back of the Cockpit.

A 2 Attach the other connector to the Dräger device.


030

3 Tighten the knurled screw to secure the


connector.
4 Prepare the Dräger device to be connected as
described in the relevant instructions for use.

Configuring the data import


See "Configuring the MEDIBUS import"
on page 98.

Preparing the PressurePod

PulmoVista 500 can display the pressure data of a The pressure values measured by the
PressurePod. The PressurePod can be attached to PressurePod can be selected on the
the handle of PulmoVista 500 and connected to one Start/Standby page, see "Monitoring sessions"
of the Cockpit's USB ports. on page 59.

NOTE All measured pressure values are displayed in the


Ptp analysis view, see "Ptp analysis" on page 70.
To use the PressurePod correctly with PulmoVista
500, read and observe the PressurePod's
instructions for use.

Instructions for use PulmoVista 500 SW 1.3n 47


Assembly and preparation

Position of the user

To be able to read the screen contents properly, it is


recommended that the user stands at the following
distances from the display:
– Less than 70 cm (27.6 in) during operation
– Less than 3 m (9.8 in) when reading displayed
data

48 Instructions for use PulmoVista 500 SW 1.3n


Getting started

Getting started

Switching on PulmoVista 500 . . . . . . . . . . . . 50

Device check. . . . . . . . . . . . . . . . . . . . . . . . . . 51
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Preparing the device check . . . . . . . . . . . . . . . 51
Performing the device check . . . . . . . . . . . . . . 52

Attaching the patient interface . . . . . . . . . . . 53


Preparing the patient . . . . . . . . . . . . . . . . . . . . 53
Attaching the electrode belt . . . . . . . . . . . . . . . 53

Connecting the trunk cable . . . . . . . . . . . . . . 59

Monitoring sessions. . . . . . . . . . . . . . . . . . . . 59
Continuing the monitoring session . . . . . . . . . . 60
Starting a new monitoring session . . . . . . . . . . 60
Selecting and activating measurements. . . . . . 60
Entering patient data . . . . . . . . . . . . . . . . . . . . 60

Instructions for use PulmoVista 500 SW 1.3n 49


Getting started

Switching on PulmoVista 500

WARNING At the end of the startup, PulmoVista 500 displays


the Start/Standby dialog window. The
Risk of electric shock and of device malfunction
Start/Standby page (B) is selected. PulmoVista
Do not use the medical device if condensation 500 is in standby mode.
is present. .

Start/Standby
CAUTION
After extended exposure to a cold environment, B H
acclimatize the device carefully so that condensa-
tion cannot form on the electronic parts and does
not damage the device. C D

Infinity C500 (MS18746) E

F
A

Infinity C500 (MK31500)


G

A
018

 Press the On/Off key (A) on the Cockpit. 500

All LEDs are tested. After initialization the startup


screen is displayed. The Start/Standby page provides the following
buttons and tabs:
– Start (C), to start measurement, see page 60
– Standby (D), to switch to standby mode,
see page 86
– On (E), to display activated EIT measurements,
see page 60
– On (F), to activate selected pressure
measurements, see page 60
– New patient (G), to start a new monitoring
session, see page 60
506

The progress bar indicates the progress of the – Device check (H), to open the device check
startup. page, see page 51

50 Instructions for use PulmoVista 500 SW 1.3n


Getting started

Device check

Overview Preparing the device check

WARNING All plugs of the trunk cable must be connected to


the EIT module.
Risk of electric shock and of device malfunc-
tion
Do not use PulmoVista 500 if the device check
has failed.

The device check must be performed prior to each


B
A
use of PulmoVista 500.The device check must be
performed at least every 24 hours if the device is in
use.
It is recommended to perform the device check in
case of persisting obvious distorted results or D

R
R
technical messages not related to known adverse TEST C
measurement conditions. L
F
Do not start the device check while the patient is L E
connected to PulmoVista 500.

031
1 Insert trunk cable plug (A) into the trunk cable
port (B).
2 Insert green patient cable plug (C) into the test
connector (D).
3 Insert red patient cable plug (E) into the test
connector (F).

Instructions for use PulmoVista 500 SW 1.3n 51


Getting started

Performing the device check The test results obtained from the device check are
stored until the next test, even if the device is
The device check is only possible in standby mode. switched off.
If PulmoVista 500 is not already in standby mode, If the device check was successful, measurements
switch to standby mode. may be started.
If the device check fails, do not operate the device.
Switching to standby mode Contact DrägerService.
1 Touch the Start/ Standby... button in the main
menu bar. On completion of the device check
2 Touch the Standby button on the  Disconnect the patient cable plugs from the test
Start/Standby page. connector on the EIT module.

Performing the device check


3 Touch the Device check (A) tab.
The status of the last device check is displayed (B).
4 Touch the Start button (C) and confirm with the
rotary knob.

Start/Standby D

C
501

PulmoVista 500 starts the device check. The device


check is completed automatically. The progress of
the device check is indicated by a help text
message (D) in the header bar.
While the device check is running, the Device
check page cannot be closed.

52 Instructions for use PulmoVista 500 SW 1.3n


Getting started

Attaching the patient interface

WARNING Attaching the electrode belt


Risk of infection
WARNING
Before each use, reprocess the medical de-
vice and all accessories in accordance with Risk of skin injury
these instructions for use, see chapter The electrode belt may cause skin injury.
"Reprocessing" on page 117. Observe the
hospital hygiene regulations! Examine the skin of the patient regularly for ir-
ritations, lesions, or other signs that may indi-
cate skin injury. If necessary, remove the elec-
WARNING trode belt.
Risk of strangulation
If the patient cable is positioned close to the CAUTION
neck, there is a risk of strangulation. Risk of skin irritation and skin injuries
Ensure, e.g., through appropriate cable man- The electrode belt may cause skin irritation or skin
agement, that the patient cable does not re- injury.
strict the patient's airways.
Take additional precautions to avoid strangu- Only use electrode belts of a suitable size so that
lation. only slight stretching of the electrode belt is re-
quired.
Check the patient's skin regularly, e.g., every
WARNING 2 hours, for irritation, wounds, or other signs of
Risk of excessive leakage current skin injury. If necessary, open or remove the elec-
When more than four additional applied parts trode belt.
from other devices are used together with Pul- Do not use the electrode belt for more than
moVista 500, make sure that the overall patient 24 hours consecutively on the same patient.
leakage current is below the safety limit spec-
ified in the standard IEC 60601-1. CAUTION
Risk of unstable circulation
CAUTION Positioning the electrode belt may lead to hemo-
Avoid damage to the cables by gripping the plugs dynamic instability in patients with unstable circu-
when disconnecting parts of the patient cable as- lation.
sembly instead of pulling on the cables.
Do not attach the electrode belt to patients where
this may pose a risk of hemodynamic instability.
Preparing the patient
CAUTION
1 Clean the respective skin areas properly. Ensure that perspiration or gel does not establish
Ensure that the respective skin surface is free of a conductive connection between the closure stud
body fluids or material which may impede of the electrode and the skin of the patient. This
electrode contact. could impair the measurement quality.
2 Remove chest hair as necessary to ensure
proper electrode contact.

Instructions for use PulmoVista 500 SW 1.3n 53


Getting started

Selecting the belt size Connecting the patient cable to the electrode
belt (for adults)
The size labels and color codes of the electrode
belt for adults and the patient cable for adults are Connect the patient cable before attaching the
the same. The patient cable for pediatric patients electrode belt to the patient.
can be used in conjunction with all electrode belts
for pediatric patients. The following table shows
size and color according to chest circumference. 1 16
Adults: B
Chest circumference Color Size
70 to 85 cm Medium blue S 1 16
(28 to 33 in)
80 to 96 cm Dark blue
A

006
M
(31 to 38 in)
1 Connect snap 1 (A) of the patient cable to
92 to 110 cm Dark red L stud 1 (B) of the electrode belt. Ensure the
(36 to 43 in) orientation of the cable over the stud is
106 to 127 cm Gray XL maintained as illustrated and as marked on the
(42 to 50 in) electrode belt.
124 to 150 cm Violet XXL 2 Connect all other snaps in numerical order to
(49 to 59 in) the studs of the electrode belt. Make sure that
the patient cable changes direction above each
Pediatric patients: stud.
Chest circumference Color Size
36 to 44 cm Medium blue 4XS
(14.2 to 17.3 in)
42 to 52 cm Violet 3XS
(16.5 to 20.5 in) C
005

49.5 to 60 cm Dark blue 2XS


(19.3 to 23.6 in) Moisture from the skin usually results in sufficient
conductivity between the skin and the electrodes a
58 to 72 cm Dark red XS few minutes after the belt has been applied. If
(22.8 to 28.3 in)
sufficient conductivity is not achieved, electrode gel
or spray may be applied to the black electrode
1 Estimate the chest circumference at the height
surface areas (C) on the electrode belt.
of the 4th to 5th intercostal space at the
medioclavicular line. 3 If the skin is obviously dry, it is recommended to
apply electrode gel or spray to the electrodes
2 Select a suitable electrode belt. The attached
before the electrode belt is applied.
electrode belt must be just tight enough to
provide sufficient contact between the skin and
the electrodes. If possible, select a belt size that
allows the use of position 3 of the belt closure
(see page 25). Other positions can affect the
accuracy of EIT data.
3 Select the patient cable with the appropriate size.

54 Instructions for use PulmoVista 500 SW 1.3n


Getting started

Attaching the electrode belt to the patient (for


adults)

Male Female
F

2
С
E

140

007
1 Place the electrode belt with the patient cable
connected at the height of the 4th to 5th 4 Close the electrode belt so that all electrodes
intercostal space (medioclavicular line) around have close contact with the skin.
the chest of the patient. For female patients Depending on the position of the belt closure, the
place the electrode belt so upon the chest in EIT image may change slightly. With increasing
such a way that its position matches distance between electrodes 1 and 16 the left and
approximately the 5th intercostal space. right ventral parts of the EIT image close up. Where
Ensure that the left-right orientation of the electrode wound dressings or other material prevent skin
belt is correctly maintained. The red patient cable contact with all 16 electrodes, EIT measurements
port must be to the patient's left and the green can be performed with only 15 electrodes.
patient cable port to the patient's right. However, at least 15 electrodes must have
effective contact with the skin.
5 Connect the closure snap (E) to the closure
stud (F).
D
Connecting the reference electrode
008

2 Ensure that the midposition marker (D) in the


center of the electrode belt is located over the
spine of the patient.
c
1

3 Ensure that the electrode belt is positioned so


2

that electrodes 1 and 16 are equidistant from


the sternal edge.
Wherever possible, attach the electrodes with an G H
equal distance to each other. Irregular electrode Ref
009

distances affect the quality of the EIT data.


6 Apply an ECG electrode (G) anywhere on the
abdomen.
7 Attach the reference electrode snap (H) to the
ECG electrode.

Instructions for use PulmoVista 500 SW 1.3n 55


Getting started

Connecting the patient cable to the electrode Attaching the electrode belt to the patient (for
belt (for pediatric patients) pediatric patients)
Connect the patient cable before attaching the Infant Pediatric patient
electrode belt to the patient.

1 15

051
1 Place the electrode belt with the patient cable
connected at the height of the 4th to 5th
intercostal space (medioclavicular line) around
15

16

1
the chest of the patient.
050

For infants, place the electrode belt as cranially as


1 Connect snap 1 (A) of the patient cable to possible directly under the armpits. Ensure that no
stud 1 (B) of the electrode belt. Ensure the skin is trapped between the electrode belt and the
orientation of the cable over the stud is patient cable or under the armpits.
maintained as illustrated and as marked on the
electrode belt.
2 Connect snaps 2 to 15 in numerical order to the
studs on the electrode belt. Make sure that the
patient cable changes direction above each
stud and that snap 16 is not attached to the
corresponding stud.

052

C The electrode belt in sizes 4XS and 3XS has cut-


046

outs for the armpits. The alignment of the


Moisture from the skin usually results in sufficient electrodes is asymmetrical. When applying the
conductivity between the skin and the electrodes a electrode belt, ensure that the cut-outs are
few minutes after the belt has been applied. If positioned under the armpits and that the
sufficient conductivity is not achieved, electrode gel electrodes are cranially aligned.
or spray may be applied to the black electrode
surface areas (C) on the electrode belt.
3 If the skin is obviously dry, it is recommended to
apply electrode gel or spray to the electrodes
before the electrode belt is applied.

56 Instructions for use PulmoVista 500 SW 1.3n


Getting started

1
Pediatric patient:

3
16

2
14
5

3
13

4
053
Ensure that the left-right orientation of the electrode

055
belt is correctly maintained. The red patient cable Infant:
port must be to the patient's left and the green
patient cable port to the patient's right.
Example for pediatric patients:

D 16

15 1 2

3
14

13 4

056
4 Close the electrode belt as follows so that all
electrodes have good skin contact:
054

2 Ensure that the midposition marker (D) in the  Attach the flap of the electrode belt to
center of the electrode belt is located over the electrode stud 16 at a suitable position of
spine of the patient. the belt closure. Attach electrode snap 16 of
the patient cable to the electrode stud of the
3 Ensure that the electrode belt is positioned in electrode belt.
such a way that electrodes 1 and 16 are the
same distance from the sternum. For pediatric patients, the maximum stretch of the
Wherever possible, attach the electrodes with electrode belt must not exceed 10 %. If the
an equal distance to each other. Irregular electrode belt shows a clearly visible deformation,
electrode distances affect the quality of the EIT the recommended stretch of the electrode belt has
data. been exceeded. If a stretch of more than 10 % is
necessary, use an electrode belt with the next
higher belt size.
Depending on the position of the belt closure, the
EIT image may change slightly. With increasing
distance between electrodes 1 and 16 the left and
right ventral parts of the EIT image close up. Where
wound dressings or other material prevent skin

Instructions for use PulmoVista 500 SW 1.3n 57


Getting started

contact with all 16 electrodes, EIT measurements 7 To prevent infants from developing pressure
can be performed with only 15 electrodes. marks, place the patient on a soft surface such
However, at least 15 electrodes must have as a Dräger SoftBed mattress or an air
effective contact with the skin. mattress.

Connecting the reference electrode


Pediatric patient:

16

1
15
14
13

3
4
15
16

1
14

3
13

Ref

G H
Ref
057

Infant:

059

1
16
15

2
14

3
13

G H
Ref
058

5 Apply an ECG electrode (G) anywhere on the


abdomen.
6 Attach the reference electrode snap (H) to the
ECG electrode.

58 Instructions for use PulmoVista 500 SW 1.3n


Getting started

Connecting the trunk cable

1 Position PulmoVista 500 next to the bed of the 2 Connect the patient cable plugs (A) of the trunk
patient. cable to the patient cable ports (B). Ensure that
the color and the label on the patient cable
A B plugs match the corresponding color and label
on the patient cable ports.
3 Make sure there is no tension on the trunk cable
L

or the patient cable. Ensure that the cables are


not tangled or looped around the extremities of
the patient.
R

004

Monitoring sessions

Before starting a monitoring session, open the Start/Standby


Signal check page. Make sure that the skin-
electrode contact of all electrodes is sufficient and
stable. See "Signal check" on page 84. A
While PulmoVista 500 is in standby mode, the
Start/Standby page (A) enables the user to choose B
between:
– Continuing the monitoring session C D
– Starting a new monitoring session
– Selecting measurements E
– Entering patient data F F F
Prerequisite: The Start/Standby page (A) is open.
PulmoVista 500 is in standby mode.

G H
500

Instructions for use PulmoVista 500 SW 1.3n 59


Getting started

Continuing the monitoring session Entering patient data

 Touch the Start button (B).  To enter the patient data, touch the Patient
data... button (H).
Trend data and reference data from the last session
are saved. Trend data is not collected while The Patient data page will open.
PulmoVista 500 is switched off or in standby mode.
Collection of trend data is resumed when the
monitoring session is continued. The measurement
starts.

Starting a new monitoring session

When a new monitoring session is started, the


trend data and reference data of the previous
patient is deleted.
1 Touch the New patient button (G). Press the
rotary knob to confirm.
2 Touch the Start button (B).
The new measurement starts.

Selecting and activating measurements

The available measurements can be selected and


activated before continuing a monitoring session or
starting a new monitoring session.
1 If a patient interface has been detected, the
On button (C) for the EIT measurements is
automatically activated.
2 If at first only one PressurePod measurement
was activated and started, the Establish
connection button (D) is displayed. To activate
the EIT measurements while pressure
measurements are in progress, touch the (D)
button.
 To activate the measurements of a connected
PressurePod, touch the On button (E).
 To select the desired pressure measurements,
touch the Paw, Pes, Pga/Paux3 buttons (F).
These buttons are only displayed if a
PressurePod is connected.

60 Instructions for use PulmoVista 500 SW 1.3n


Operation

Operation

Safety information for operation. . . . . . . . . . 62

Starting a new measurement. . . . . . . . . . . . . 63


15-electrode mode . . . . . . . . . . . . . . . . . . . . . . 63

Main view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Setting ROIs . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Displaying reference data. . . . . . . . . . . . . . . . . 67
Deleting reference data . . . . . . . . . . . . . . . . . . 68

Other views . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Selecting a view . . . . . . . . . . . . . . . . . . . . . . . . 69
Full-screen image . . . . . . . . . . . . . . . . . . . . . . . 69
Ptp analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
End-inspiratory trend . . . . . . . . . . . . . . . . . . . . 73
EELI trend . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Freeze display. . . . . . . . . . . . . . . . . . . . . . . . . 82

Export screenshot . . . . . . . . . . . . . . . . . . . . . 82

Marking events . . . . . . . . . . . . . . . . . . . . . . . . 82

Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . 84
Signal quality indicator . . . . . . . . . . . . . . . . . . . 84
Signal check . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Standby mode. . . . . . . . . . . . . . . . . . . . . . . . . 86
Activating standby mode . . . . . . . . . . . . . . . . . 86

Additional functions provided by the


option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Data recording . . . . . . . . . . . . . . . . . . . . . . . . . 87
Data review. . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Ending operation . . . . . . . . . . . . . . . . . . . . . . 91
Switching off the system. . . . . . . . . . . . . . . . . . 91
Removing the patient interface. . . . . . . . . . . . . 91
Disconnecting PulmoVista 500 from
a Dräger device . . . . . . . . . . . . . . . . . . . . . . . . 92

Instructions for use PulmoVista 500 SW 1.3n 61


Operation

Safety information for operation

WARNING
Risk of excessive leakage current to the pa-
tient
Do not simultaneously touch the contacts of
any connector and the patient.

WARNING
Risk of image distortion which may lead to
wrong therapeutic decisions
The following sources may distort the clinical
information content of EIT data:
– Patient movement, muscle contractions
– Changes of skin-electrode contact
– Changes of fluid accumulation in the tho-
rax or under the skin
– Movement of fluids or tissue, e.g., dia-
phragm, into or within the electrode plane
– Very low impedance of the thorax, e.g., due
to thickened skin or pulmonary edema
– Adiposity
– Temperature changes
For more information refer to the sections
"Signal quality" on page 84 and "General con-
siderations" on page 147.

CAUTION
Screenshots contain compressed information.
The image quality of screenshots might be affect-
ed by artifacts or loss of information.

NOTE
PulmoVista 500 does not provide a warning when
the battery is depleted.

62 Instructions for use PulmoVista 500 SW 1.3n


Operation

Starting a new measurement

 Touch the Start button on the 15-electrode mode


Start/Standby page.
PulmoVista 500 automatically starts a calibration If during calibration within a started or restarted
cycle. measurement contact between the skin and an
electrode cannot be adequately established (e.g.,
During calibration PulmoVista 500 performs the resistance between the skin and the electrode too
following actions: great, wound dressing, disconnected electrodes),
– Determination of the skin-electrode transfer the device starts in the 15-electrode mode.
impedances of all electrodes Whereas the image resolution may be reduced,
– Determination if the 15-electrode mode must be measurements can be continued without
activated, see "15-electrode mode" on page 63 limitations. The message 15-electrode mode is
– Optimization of the measurement frequency displayed in the header bar. The area around the
(when operating frequency is set to Auto, see inactive electrode is highlighed in color in the
"Adjustment of operating frequency" margin of the EIT images.
on page 101)
– Automatic adjustment of the scales of EIT To restore the 16-electrode mode, see page 110.
waveforms and images
During calibration a message is displayed in the
header bar. A countdown timer shows the seconds
until calibration is finished.
The following functions are not available during
calibration:
– Record
– Mark event
– Reference
During calibration preliminary EIT data are
displayed which are subject to change.
When calibration is finished, PulmoVista 500 shows
calibrated EIT data on the standard monitoring
screen (Main view).

Instructions for use PulmoVista 500 SW 1.3n 63


Operation

Main view

The Main view is the standard monitoring page. C Global impedance waveform – this shows the
relative impedance changes of the entire
Images represent the regional distribution of
electrode plane and, if available and
ventilation, i.e., the change of lung volume within
configured, a waveform imported via
the electrode plane. Waveforms represent the
MEDIBUS, MEDIBUS.X, or from the
volume changes within the electrode plane or parts
PressurePod (as selected on the System
of it over time. Parameters represent regional
setup page)
volume changes as a percentage of the whole.
D Regional impedance waveforms – represent
Regions of interest (ROIs) are defined for all views
relative impedance changes of the defined ROI
from this page.
E Blue markers – represent beginning and end of
The Main view displays the following:
inspiration

E I F F Parameter field – displays the tidal rate


C NOTE
A G
The tidal rate determined by PulmoVista 500 de-
D H pends on user-selected filter settings and thus
may not reflect the respiratory rate of the patient.
B
D H For this reason, the determination of the Tidal rate
K J is not defined as a measuring function in the sense
D H of the Directive 93/42/EEC concerning medical de-
vices.
D H
509

G Parameter field – displays the following:


A Dynamic image – shows impedance changes in – Global tidal variation TV global or global
a caudo-cranial image referenced to a dynamic minute tidal variation MTV global
baseline. depending on the selected status image,
always defined as 100 %
B Status image, as selected in System setup, – Tidal volume VT, if available
see page 97.
– Tidal image: Differential image of the end of H Parameter fields – display the regional tidal
inspiration compared to the beginning of variation or regional minute tidal variation as a
inspiration, which represents regional percentage of TV global or MTV global
distribution of impedance changes of the depending on the selected status image and the
last detected breath. defined ROI
– Minute image: Tidal images averaged over Numeric values, see page 153.
the last minute
I Reference button Ref
Electrode positions are represented in the dynamic
images and status images. If the skin-electrode J Button Set ROI... for setting ROI
impedance is too great, the corresponding K Button Enhance contrast – While this button is
electrode is displayed in red. If the skin-electrode pressed, the colors in all images are displayed
impedance is too unstable, the corresponding more vividly in particular to support the
electrode is displayed in white. recognition of regions with oppositely phased
impedance changes.

64 Instructions for use PulmoVista 500 SW 1.3n


Operation

Displaying reference data The Set ROI... page provides the following buttons
and tabs:
See "Displaying reference data" on page 67.
A Vertical slider – moves the ROI vertically within
the image (inactive when the set ROIs cover the
Setting ROIs entire height of the image)
B Horizontal slider – moves the ROI horizontally
This function is used to define ROIs of 4 equal sizes within the image (inactive when the set ROIs
within the status image. A region of interest (ROI) is cover the entire width of the image)
a user-defined area within a status image. The
image can be divided horizontally or into quadrants. C Width – changes the width of ROIs
The area covered by each ROI is represented by D Height – changes the height of ROIs
the corresponding regional impedance waveform.
E Layers – ROIs are adjacent and vertically
ROIs may overlap or be set so that the ROIs do not aligned
cover the entire thoracic contour. It is not possible
to move the ROIs beyond the border of the image. F Quadrants – ROIs are adjacent and positioned
It is possible that the ROIs do not represent all the in an upper left/right and lower left/right
ventilation in the measured plane. arrangement

Prerequisite: The Main view or End-insp. trend G Free – single ROIs can be moved
view is open. independently of each other

 Touch the Set ROI... button.


Setting ROIs as layers
Set ROI

B 536

1 Touch the Layers button (E).


C D
2 Touch the button in the Width line (C). Set the
E F G value by turning the rotary knob and press to
confirm.
3 Touch the button in the Height line (D). Set the
530

value by turning the rotary knob and press to


confirm.
4 Touch the horizontal (B) or vertical (A) slider.
Move the ROIs by using the touch screen or by
turning the rotary knob. Alternatively, the ROIs
can also be moved by touching and dragging
them within the image.

Instructions for use PulmoVista 500 SW 1.3n 65


Operation

Setting ROIs as quadrants Setting ROIs independently of each other

Set ROI

G
537

1 Touch the Quadrants button (F). A B C D


2 Touch the button in the Width line (C). Set the
value by turning the rotary knob and press to E F
confirm.
3 Touch the button in the Height line (D). Set the

519
value by turning the rotary knob and press to
1 Touch the Free button (G).
confirm.
The buttons ROI 1 (A), ROI 2 (B), ROI 3 (C), and
4 Touch the horizontal (B) or vertical (A) slider.
ROI 4 (D) are displayed.
Move the ROIs by using the touch screen or by
turning the rotary knob. Alternatively, the ROIs 2 Touch the relevant button for the ROI.
can also be moved by touching and dragging
3 Touch the button in the Width line (E). Set the
them within the image.
value by turning the rotary knob and press to
confirm.
4 Touch the button in the Height line (F). Set the
value by turning the rotary knob and press to
confirm.
5 Touch the horizontal (G) or vertical (H) slider.
Move the ROIs by using the touch screen or by
turning the rotary knob. Alternatively, the ROIs
can also be moved by touching and dragging
them within the image.

66 Instructions for use PulmoVista 500 SW 1.3n


Operation

Displaying reference data Reference waveforms


When the status image is set to Tidal, the reference
Prerequisite: The Main view is open. waveform is made up of repeated sequences of the
 Touch the Ref button (A). impedance waveform of the reference breath. The
reference breath is the last detected breath before
A the Ref button was pressed.
D B When the status image is set to Minute, the
reference waveform is made up of the impedance
D E waveform of the breaths within the last minute
before the Ref button was pressed. In this case, the
D E
duration of the reference waveform displayed
D E depends on the selected time scale. When the time
scale is set to less than one minute, only the first
D E part of the reference waveform is displayed. When
C the time scale is set to longer than one minute, then
E the reference waveform is made up of repeated
520

sequences of one minute, or part thereof.


Reference data are displayed in the following form:
For setting the status image, see page 97.
– Reference time (B) is displayed as hh:mm
– Status image reference (C) Reference parameters
– Unfilled blue impedance waveform overlaid on Reference parameters represent the distribution of
pale blue solid impedance waveform (D) regional (minute) tidal variations in the reference
– Reference parameter in the corresponding status image. Deviation bars in the parameter fields
parameter box (E), in addition to the current indicate the change in the distribution of regional
value (minute) tidal variations between the reference
status image and the current status image. The
current and reference values of the global tidal
Status image variation (TV global) are always defined as 100 %,
When the status image is set to Tidal, the reference regardless of the possibly different tidal variations
image is the tidal image at the time the Ref button at the different times. Hence, the difference
was pressed. between current and reference regional tidal
variations represents the redistribution of regional
When the status image is set to Minute, the tidal variation. In contrast, the status images and
reference image is the minute image at the time the waveforms display increases and decreases in the
Ref button was pressed. absolute values of the tidal variation. (Only when
For setting the status image, see page 97. the reference function is activated, otherwise the
autoscaling of the images and curves will "hide"
these effects.)

Changing filter settings


If reference data are displayed and filter settings
are changed, the changed filter settings will not
affect the displayed reference data.

Instructions for use PulmoVista 500 SW 1.3n 67


Operation

Displaying changes Deleting reference data


To display the changes between the reference data
and the current data. Prerequisite: Reference data are displayed.

 Touch the Display change button (F).  Touch the Ref button (A).
The following actions will lead to the loss of
A reference data:
– PulmoVista 500 is switched off.
– Standby mode is activated and the frame rate is
changed.
H
G – Standby mode is activated and New patient is
F I selected.
– The simulation mode is activated.
J
521

The status image is replaced by the image


Change: Current minus Ref (G). This image (G)
represents the differences between the current
status image and the reference image. Changes
are displayed on a different color scale,
see page 162.
The deviation from the reference parameter is
graphically displayed:
– No changes (H)
– Increased (I)
– Decreased (J)
In contrast to the image (G), the displayed
deviations in the parameter fields only reflect
changes of regional distribution. Changes of Tidal
variations which do not affect the regional
distribution are not displayed as deviations.

68 Instructions for use PulmoVista 500 SW 1.3n


Operation

Other views

The display of the measured data can be changed Full-screen image


by the user in the Views dialog window. The
following views can be selected: The Full-screen image view provides a large
format view of the status image or dynamic image,
as selected in System setup, see page 94. The
Views image not selected for large format viewing is
A shown in small format.
B The Full-screen image view displays the
following:
C
D AB D
A E
E
E
F
E
511

A Main E
C
B Full-screen image
E
C Ptp analysis
D End-insp. trend
E

518
E EELI trend A Small format image, according to selection in
System setup
F Diagnostics
B Global impedance waveform
C Large format image, as selected in System
Selecting a view setup

1 Touch the Views... button in the main menu bar. D Ref button

2 Touch the button to select the desired view. E Parameter fields as in the Main view

3 Touch the X button to close the dialog window


or wait for the Views dialog window to close Displaying reference data
automatically after a few seconds.  See "Displaying reference data" on page 67.

Instructions for use PulmoVista 500 SW 1.3n 69


Operation

Ptp analysis H Parameter field – this displays the following


parameters, which were determined from the
The Ptp analysis view enables the evaluation of the airway pressure waveform Paw (Pod) (C), if
pressure waveforms imported from the PressurePod available:
and the transpulmonary pressure waveform – End-inspiratory pressure EIP
calculated on the basis of these. The Ptp analysis
view shows the following information depending on – Positive end-expiratory pressure PEEP
the pressures selected on the Start/Standby page – Difference Paw between EIP and PEEP
and the settings on the System setup page: driving pressure
I Parameter field – this displays the following,
A B G if available:
C – End-inspiratory esophageal pressure EIPes
H – End-expiratory esophageal pressure EEPes
L D
I – Difference Pes between EIPes and EEPes
esophageal driving pressure
E
J J Parameter field – this displays the following,
if available:
M N F
O K – End-inspiratory transpulmonary pressure
P
558

EIPtp
A Status image or dynamic image (as selected on – End-expiratory transpulmonary pressure
the System setup page) EEPtp
B Global impedance waveform and, if available, a – Difference Ptp between EIPtp and EEPtp
waveform imported via MEDIBUS, transpulmonary driving pressure
MEDIBUS.X, or from the PressurePod (as
selected on the System setup page) K Parameter field – this displays the following, if
available:
C Airway pressure waveform Paw (Pod) imported
from the PressurePod (as selected on the – End-expiratory gastric pressure EEPga
Start/Standby page) – Transdiaphragmatic pressure Pdi
D Esophageal pressure waveform Pes (Pod) L Pulmonary image – schematic, graphic
imported from the PressurePod (as selected on representation of the pressure measurements
the Start/Standby page) Paw, Pes, and Pga, and of the determination of
E Calculated transpulmonary pressure waveform the parameter Ptp
Ptp M Static analysis... button for the manual
determination of end-inspiratory and end-
F Gastric pressure waveform Pga/Paux3 (Pod)
expiratory plateau pressures
imported from the PressurePod (as selected on
the Start/Standby page) N Occlusion test... button for checking the
placement of the esophageal balloon
G Parameter field – this displays the following, if
available: O Filter... button for setting a specific low-pass
filter for the pressure waveforms of the
– Tidal Rate PressurePod
– Tidal volume VT imported via MEDIBUS or P Pes... button for checking the filling of the
MEDIBUS.X esophageal balloon

70 Instructions for use PulmoVista 500 SW 1.3n


Operation

Performing the static analysis To select the plateau points, do the following:
End-inspiratory and end-expiratory plateau points 1 Place the cursor (E) at the desired position on
can be selected manually on the Static analysis the end-expiratory plateau.
page, with which a more precise determination of
2 Place the cursor (F) at the position immediately
the parameter Ptp is possible.
before or after that on the end-inspiratory
plateau.
Static analysis X

The values resulting from the cursor positioning are


A B C displayed in the Lung mechanics table (A) and in
the parameter fields (C).
B C
Performing the occlusion test
B C On the Occlusion test page, an end-expiratory
occlusion maneuver can be marked in the
B C displayed waveforms using the sliders. In the
marked section of the waveform, peaks or dips in
D E F G the airway pressure waveform Paw and in the
563

esophageal pressure waveform Pes can be


A Lung mechanics table. If MEDIBUS or
compared with one another. With a ratio of Pes
MEDIBUS.X values are available, the following
and Paw between 0.8 and 1.2, the measurement
data is displayed depending on the cursor
of the esophageal pressure Pes is considered to be
positioning:
reliable.
– Elastance or compliance of the respiratory
system, the lungs and the chest wall (as Occlusion test X

selected on the System setup page) D


– Pressure-time products of the esophageal A B
pressure and transdiaphragmatic pressure
B Waveform fields as in the Ptp analysis view.
C
The Pga/Paux3 (Pod) gastric pressure E G G
waveform is not displayed.
F H
C Parameter field as in the Ptp analysis view. 562

The parameter field for gastric pressure Pga A The Pes/Paw match diagram shows the
and for transdiaphragmatic pressure Pdi is not overlaid sections of the Paw (Pod) and Pes
displayed. (Pod) waveforms marked with the sliders.

D Filter... button for setting the low-pass filter for B Paw (Pod) airway pressure waveform imported
the pressure waveforms of the PressurePod from the PressurePod

E Cursor button for the end-expiratory C Pes (Pod) esophageal pressure waveform
plateau imported from the PressurePod

F Cursor button for the end-inspiratory D Help... button


plateau E Parameter field for displaying the ratio of the
G Refresh button Pes and Paw parameters
F Filter... button for setting the low-pass filter for
the pressure waveforms of the PressurePod

Instructions for use PulmoVista 500 SW 1.3n 71


Operation

G Horizontal sliders for marking the occlusion Displaying the trend of the Pes parameter
phase
On the Pes page, the filling of the esophageal
H Refresh button balloon and the resulting changes to the Pes
parameter can be checked.
Defining filters
Pes
On the Filter page, cardiac artifacts can be
suppressed in the pressure waveforms that are B
imported from the PressurePod. The low-pass filter A
settings have no effect on other displayed C

561
waveforms.
A Trend waveform of the Pes parameter
Filter B Button for the time scale
C Refresh button – for updating the time scale
A

B
560

A Low-pass filter button


B Button for setting the cut-off frequency
To activate the filter and set the cut-off frequency,
perform the following steps:
1 Touch the (A) button to switch on the filter.
2 Touch the (B) button.
3 Set the value by turning the rotary knob and
press to confirm.

72 Instructions for use PulmoVista 500 SW 1.3n


Operation

End-inspiratory trend G Cursor position C


H Table displaying the following data at the
The End-insp. trend view provides a comparative selected cursor positions:
evaluation of two status images, each representing – Tidal variation values, expressed as
the regional distribution of impedance changes at percentages
two different cursor positions. In the End-insp. – MEDIBUS, MEDIBUS.X, or PressurePod
trend view the differences between these two data, if available and as selected in the
status images are displayed. These can be system configuration, see page 98
interpreted as changes of the regional distribution – Date and time
of the tidal volume in the electrode plane.
I Global impedance waveform – up to 2 hours of
The changes in the status images at Ref and C are data is displayed as a compressed waveform.
expressed as follows:
J MEDIBUS, MEDIBUS.X, or PressurePod trend
Zero change No difference between val- parameters, if available, and as selected in the
ues at Ref and C system configuration, see page 98
Positive changes Value at C is greater than the K Button for the time scale (inactive when the
value at Ref zoom area has been zoomed into)
Negative changes Value at C is less than the L Refresh button (inactive when the zoom area
value at Ref has been zoomed into)

The End-insp. trend view displays the following: If signal quality is low, this is indicated at the cursor
label and then the waveform is a darker gray color.

A B C M Event list... button - all events since the start of


measurement are displayed in a table.
N Button Set ROI... – to define ROIs.
N
O Button for opening the Zoom page – enables
I F G O the selection of a zoom area within the trend
P data.
H P Button for zooming in/zooming out – allows the
J K zooming in and zooming out of the zoom area
M D L (inactive when no zoom area has been
E defined).
532

A Differential image Change: C minus Ref,


displays an image based on the differences Setting the cursor position
between the status images at cursor positions
Ref and C 1 Touch the relevant cursor button Ref (D) or
C (E).
B Status image Ref – refers to cursor
position Ref 2 Select the desired point in time by turning the
rotary knob. Alternatively, touch the relevant
C Status image C – refers to cursor position C cursor and move it by swiping in the waveform
D Cursor button Ref field.

E Cursor button C If the cursor position is changed in the End-insp.


trend view, the cursor is set to the same position in
F Cursor position Ref the EELI trend view.

Instructions for use PulmoVista 500 SW 1.3n 73


Operation

Setting the time scale The EELI trend view displays the following:
The time scale determines the duration of the trend O B
waveforms. The time scale can be set from 1 to H I D
120 minutes. The default setting is 10 minutes. P
A C E
1 Touch the Time scale button (K).
2 Select the time by turning the rotary knob and C E
press to confirm.
C E
If the time scale is changed in the End-insp. trend
view, the time scales also change in the EELI J C E
trend view and the Diagnostics view.
K L
Refreshing EIT data N F M
G

531
 Touch the Refresh button (L) (inactive when the
zoom area has been zoomed into). A Differential image EELI: C minus Ref –
displays an image based on the differences
CAUTION between the end-expiratory values at cursor
positions Ref (H) and C (I).
Risk of wrong therapeutic decisions
B Global impedance waveform – up to
The trend views are affected by various factors.
120 minutes of data are displayed as a
For information on the influencing factors see
compressed waveform. The end-expiratory
page 147.
level at each cursor position is displayed as a
horizontal dashed line.

EELI trend C Regional impedance waveforms – up to


120 minutes of data are displayed as a
In the EELI trend view the changes of the end- compressed waveform. The end-expiratory
expiratory lung impedance are displayed. These level at each cursor position is displayed as a
can be interpreted as changes of the end- horizontal dashed line.
expiratory lung volume in the electrode plane. The D Parameter field EELI global – the change in
change in end-expiratory lung impedance ∆EELI at global end-expiratory lung impedance,
Ref and C is expressed as follows: expressed as a factor of the global tidal
variation at the cursor position Ref.
Zero change No difference between val-
ues at Ref and C E Parameter fields ∆EELI ROI – the change in
end-expiratory lung impedance for the
Positive changes Value at C is greater than the
corresponding ROI, expressed as a factor of the
value at Ref
global tidal variation at the cursor position Ref.
Negative changes Value at C is less than the
value at Ref F Cursor button Ref
G Cursor button C
H Cursor position Ref
I Cursor position C

74 Instructions for use PulmoVista 500 SW 1.3n


Operation

J Table displaying the following data at the Setting the time scale
selected cursor positions Ref and C:
The time scale determines the duration of the trend
– Tidal variation values, expressed as
waveforms. The time scale can be set from 1 to
percentages
120 minutes. The default setting is 10 minutes.
– MEDIBUS, MEDIBUS.X, or PressurePod
data, if available, and as selected in the 1 Touch the Time scale button (L).
system configuration, see page 98
2 Select the time by turning the rotary knob and
– Date and time
press to confirm.
K MEDIBUS, MEDIBUS.X, or PressurePod trend
If the time scale is changed in the EELI trend view
parameters, if available, and as selected in the
and the Diagnostics view, the time scale also
system configuration, see page 98
changes in the End-insp. trend view.
L Time scale button (inactive when the zoom
area has been zoomed into)
Refreshing EIT data
M Refresh button (inactive when the zoom area
 Touch the Refresh button (M) (inactive when
has been zoomed into)
the zoom area has been zoomed into).
N Event list... button - all events since the start of
measurement are displayed in a table. CAUTION
O Button for opening the Zoom page – enables Risk of wrong therapeutic decisions
the selection of a zoom area within the trend The trend views are affected by various factors.
data. For information on the influencing factors see
P Button for zooming in/zooming out – allows the page 147.
zooming in and zooming out of the zoom area
(inactive when no zoom area has been
defined).
 If signal quality is low, this is indicated at the
cursor label and then the waveform is a darker
gray color.

Setting the cursor position


1 Touch the relevant cursor button Ref (F)
or C (G).
2 Select the desired point in time by turning the
rotary knob. Alternatively, touch the relevant
cursor and move it by swiping in the waveform
field.
If the cursor position is changed in the End-insp.
trend view, the cursor is set to the same position in
the EELI trend view.

Instructions for use PulmoVista 500 SW 1.3n 75


Operation

Diagnostics A Global impedance waveform – up to 2 hours of


data are displayed as a compressed waveform
The Diagnostics view enables the systematic in relation to time. If available, the trend
analysis of regional compliance changes and parameters PEEP and EIP imported via
delays in regional ventilation in a maximum of MEDIBUS or MEDIBUS.X are also displayed.
15 time periods in addition to the evaluation of On older ventilators which do not transmit
ventilation distribution. Every time period is called a EIPvalues,PIP values are displayed instead..
“section”. PIP equals EIP during pressure-controlled
ventilation and volume-controlled ventilation
The Diagnostics view initially shows the Conduct with AutoFlow.
analysis dialog window in which the following
functions can be selected: B Sections with alphabetically sorted labels – the
respective PEEP value is also displayed in the
The Recruitability function enables the label if PEEP measured values are available.
simultaneous evaluation of changes in the
compliance and end-expiratory lung volume, C Zoom button – only available if the horizontal
particularly as a result of recruitment maneuvers. sliders (D) are not at the start and end of the
scale.
The PEEP trial function enables the automatic
analysis of incremental or decremental PEEP D Horizontal sliders for adjusting the zoom area –
maneuvers, in which the PEEP is increased or sections can only be automatically defined and
decreased in steps. manually added in the area between the sliders.
In contrast, the Customized function enables the E Recruitability – only active if at least two
evaluation of any other ventilation-therapeutic sections were defined in the trend data.
interventions. Both functions facilitate the F PEEP trial – only active if a PEEP maneuver
evaluation of maneuvers and interventions. was automatically detected in the trend data or
If the trend data contain a PEEP maneuver, the if at least 3 sections were placed on incremental
changes of the end-expiratory lung impedance or decremental levels of the end-expiratory lung
(EELI) caused by the PEEP adjustment are impedance.
detected automatically and a section is defined for G Customized – only active if at least two
every detected EELI level. The PEEP trial function sections were defined in the trend data.
can be started immediately.
H Button for the time scale – only active if the
If no PEEP maneuver is detected in the trend data, zoom button is not selected.
the user can define own sections at any point in the
displayed trend area and analyze these sections I Refresh – for activating the time scale (only
with the Customized function. active if the zoom button is not selected).

The Conduct analysis dialog window displays the The Conduct analysis dialog window also
following elements: contains the Sections and RVD configuration
pages.
X

A B NOTE
The previous analysis is deleted every time the
C section settings are changed.
D D
E F G H
I
557

76 Instructions for use PulmoVista 500 SW 1.3n


Operation

Configuring the section settings Configuring the RVD settings

A A
B C D B C
E D
F E H
F G

555
554
On the Sections page (A), the user can make the On the RVD page (A), the user can make the
following settings: following settings:
– Automatically define sections (B) – The – Switch the calculation and display of the RVD
sections are automatically defined and can be parameter on (B) or off (C).
shifted as needed by tapping on a section on
– Set the cut-off frequency of the low-pass filter
the global waveform and dragging it across the
for RVD (D).
screen to the desired position or moving it there
by turning the rotary knob. To confirm the – Set the RVD threshold (E). All pixels with an
position, press the rotary knob or tap outside of RVD value greater than the set RVD threshold
the waveform field. are displayed in yellow.
– Manually add a section (C) – The new, light gray – Select the RVD parameter. Touch the RVD
section is added in the middle of the two sliders Ratio (F) or RVD SD (G) button. RVD Ratio, in-
and can be moved to the desired position by dicated as % of the total number of pixels of the
tapping the waveform field, dragging the section ventilated area, describes the ratio of the num-
across the screen, or by turning the rotary knob. ber of pixels with an RVD above the RVD
To confirm the position, press the rotary knob or threshold to the total number of pixels. RVD SD,
tap outside of the waveform field. To confirm the indicated as % of Ti, describes the standard de-
position, press the rotary knob or tap outside of viation of all RVD values of the ventilated area.
the waveform field.
If the calculation and display of the RVD parameter
– Manually delete a section (D) – Tap the desired is switched off, only the buttons (B) and (C) are active.
section. The section is highlighted in light gray.
The following relevant notes (H) on using and
Touch the Remove section button (D). Another
interpreting the RVD parameter must be observed:
section can be selected by turning the rotary
knob. Press the rotary knob to delete the The regional ventilation delay (RVD) is a parameter
section. which displays regional inspiration delays
compared to global inspiration and may indicate the
– Define spontaneous breaths or mandatory
cyclical collapse and re-opening of lung regions as
breaths per section (E).
well as display regionally varying time constants.
– Define the reference section for the Varying time constants have a particularly heavy
Customized function (F). impact on the display of the RVD parameter during
long inspiratory times, short expiratory times and a
Sections can only be moved within the area defined
quick rise in ventilation pressure. A “long”
by the sliders.
ventilation phase can be recognized based on the
patient flow of 0 at its end.
The influence of varying time constants can be
largely suppressed through a slow pressure rise up
to the end of the inspiration and a long expiratory
time.

Instructions for use PulmoVista 500 SW 1.3n 77


Operation

Results of the analysis


If the Recruitability button is pressed, the
Conduct analysis dialog window will close. The
results of the analysis are displayed as follows:

M
A

C
D
K K
F
E
G
N
H I
O
J P
L Q
565
A Global impedance waveform – up to 2 hours of C Tidal images (max. 5 images are displayed
data are displayed as a compressed waveform simultaneously)
in relation to time. If available, the trend
– With an active RVD analysis: Areas in which a
parameters PEEP and EIP imported via
regional delay was detected, depending on the
MEDIBUS or MEDIBUS.X are also displayed.
configuration, are displayed in yellow. Tapping a
Sections whose tidal images are displayed in
tidal image opens the RVD analysis dialog
the analysis are highlighted in light gray.
window which displays an RVD image. The
Sections which are not displayed are displayed
RVD image displays an early inspiration
in dark gray.
compared to the global progression in cyan and
B Zoom button – only available if the horizontal a delayed inspiration in yellow. Furthermore, the
sliders are not at the start and end of the scale. progression of the impedance waveform of a
selected pixel is compared to the progression of
the global impedance waveform. By tapping the
displayed image, any pixel can be selected.

78 Instructions for use PulmoVista 500 SW 1.3n


Operation

– With an inactive RVD analysis: Areas in which a L Event list...


regional delay was detected are not marked.
M Help...
Tapping a tidal image opens the Details dialog
window in which the tidal image is displayed in N Conduct analysis...
a larger format and the progression of the
O Capture analysis – The currently displayed
impedance waveform of a pixel is compared to
analysis is saved as a screenshot.
the progression of the global impedance
waveform. P Review analysis... – only active if at least one
analysis is saved. Saved analyses can be
D Display of the RVD parameter – Depending on
opened and viewed in a separate dialog
the configuration, for every section expressed
window.
as the standard deviation of the RVD (RVD SD)
or as the RVD Ratio. RVD SD, indicated as % of Q Create report – only active if a USB mass
Ti, describes how inhomogeneous the regional storage device with sufficient storage space is
inspiration within the contour of the ventilated connected to the Cockpit. An image file is
area is. RVD Ratio, indicated as % of the total created containing the entered patient data, the
number of pixels, describes the ratio of the event list, all available analysis parameters and
pixels with RVD to the total number of pixels MEDIBUS values, and a screenshot of the
within the contour of the ventilated area. analysis. Furthermore, an editable text file with
the same information but without the
E Images of the compliance changes in
screenshot is created. Reports can also be
comparison to the selected reference section
created based on previously saved analyses.
for every displayed section, referred to as a
To do this, the saved analysis must be selected
compliance win (C win [%]) and Compliance
with the Review analysis... button, followed by
loss (C loss [%]). The regions with compliance
tapping the Create report button.
win are displayed in cyan and the areas with
compliance loss in orange.
F Next to the images, the sum of the values for
C win [%] is displayed in cyan.
G Next to the images, the sum of the values for
C loss [%] is displayed in orange.
H Differential images ∆EELI for each section
shown based on the selected reference section.
The end-expiratory lung impedance win
(EELI win [%]) is shown in cyan. The end-
expiratory lung impedance loss (EELI loss [%])
is shown in orange.
I Sum of the values for EELI win [%] in cyan
J Sum of the values for EELI loss [%] in orange
K Scroll buttons for shifting the displayed images
– only active if more than 5 sections are
defined.

Instructions for use PulmoVista 500 SW 1.3n 79


Operation

If the PEEP trial or Customized button is pressed,


the Conduct analysis dialog window closes. The
results of the analysis are displayed as follows:

K
A

C
D
I I
F
E G

L
H M
N
J O

556
A Global impedance waveform – up to 2 hours of C Tidal images (max. 5 images are displayed
data are displayed as a compressed waveform simultaneously)
in relation to time. If available, the trend
– With an active RVD analysis: Areas in which a
parameters PEEP and EIP imported via
regional delay was detected, depending on the
MEDIBUS or MEDIBUS.X are also displayed.
configuration, are displayed in yellow. Tapping a
Sections whose tidal images are displayed in
tidal image opens the RVD analysis dialog
the analysis are highlighted in light gray.
window which displays an RVD image. The
Sections which are not displayed are displayed
RVD image displays an early inspiration
in dark gray.
compared to the global progression in cyan and
B Zoom button – only available if the horizontal a delayed inspiration in yellow. Furthermore, the
sliders are not at the start and end of the scale. progression of the impedance waveform of a
selected pixel is compared to the progression of
the global impedance waveform. By tapping the
displayed image, any pixel can be selected.

80 Instructions for use PulmoVista 500 SW 1.3n


Operation

– With an inactive RVD analysis: Areas in which a G In addition to the images, the sum of the values
regional delay was detected are not marked. for C loss LP [%] or C loss [%] is displayed as
Tapping a tidal image opens the Details dialog follows:
window in which the tidal image is displayed in
– PEEP trial: Compliance loss towards lower
a larger format and the progression of the
PEEP levels (C loss LP [%]) in white
impedance waveform of a pixel is compared to
the progression of the global impedance – Customized: Compliance loss (C loss [%]) in
waveform. orange
D Display of the RVD parameter – Depending on H Diagram with the numeric values of all sections
the configuration, for every section expressed depending on the settings and analysis type.
as the standard deviation of the RVD (RVD SD)
I Scroll buttons for shifting the displayed images
or as the RVD Ratio. RVD SD, indicated as % of
– only active if more than 5 sections are
Ti, describes how inhomogeneous the regional
defined.
inspiration within the contour of the ventilated
area is. RVD Ratio, indicated as % of the total J Event list...
number of pixels, describes the ratio of the
K Help...
pixels with RVD to the total number of pixels
within the contour of the ventilated area. L Conduct analysis...
E PEEP trial: Images of the Compliance loss for M Capture analysis – The currently displayed
every displayed section. The pixel compliance analysis is saved as a screenshot.
loss is calculated in relation to the maximum
N Review analysis... – only active if at least one
compliance which is ascertained within all
analysis is saved. Saved analyses can be
sections. If there is a compliance loss towards
opened and viewed in a separate dialog
higher PEEP levels (C loss HP [%]), the loss is
window.
displayed in orange. If there is a compliance
loss towards lower PEEP levels (C loss LP O Create report – only active if a USB mass
[%]), the loss is displayed in white. The regions storage device with sufficient storage space is
without a compliance loss are displayed in dark connected to the Cockpit. An image file is
gray. created containing the entered patient data, the
Customized: Images of the compliance event list, all available analysis parameters and
changes in comparison to the selected MEDIBUS values, and a screenshot of the
reference section for every displayed section, analysis. Furthermore, an editable text file with
referred to as a compliance win (C win [%]) and the same information but without the
Compliance loss (C loss [%]). The regions with screenshot is created. Reports can also be
compliance win are displayed in cyan and the created based on previously saved analyses.
areas with compliance loss in orange. To do this, the saved analysis must be selected
with the Review analysis... button, followed by
F In addition to the images, the sum of the values
tapping the Create report button.
for C loss HP [%]or C win [%] is displayed as
follows:
– PEEP trial: Compliance loss towards higher
PEEP levels (C loss HP [%]) in orange
– Customized: Compliance win (C win [%]) in
cyan

Instructions for use PulmoVista 500 SW 1.3n 81


Operation

Freeze display

The Main and Full-screen image views provide a – All waveforms


Freeze display function. – Numerical values in the Main and Full-screen
image and Ptp analysis view views
To activate the freeze display function:
While the "freeze display" function is active, all
 Touch the Freeze display button in the main
buttons in the main menu bar except Freeze
menu bar.
display and Record are inactive.
The following is immediately frozen:
To deactivate the freeze display function:
– Dynamic image
– Status image  Touch the Freeze display button in the main
menu bar once again.

Export screenshot

This function is only available if a USB storage The screen image is written to the USB storage
medium with sufficient storage space is connected medium as a bitmap file.
to the Cockpit.
The USB storage medium may be removed when
1 Connect a USB storage medium to the left or the button turns light green.
right USB port on the Cockpit. When the USB
storage medium is correctly connected, the
Export screenshotbutton turns light green.
2 Touch the Export screenshot button in the
main menu bar. When the button is touched,
it turns dark green.

Marking events

The user can mark events during measurement. An Mark event


event is marked with the time when the button was A B
pressed. Events are flagged with a number, which
is automatically incremented. The events can be C D
annotated. All events which are entered during the
entire measuring time frame, can be viewed on the
Event list page.
E
 Touch the Mark event... button in the main
menu bar.
544

82 Instructions for use PulmoVista 500 SW 1.3n


Operation

The Mark event page displays the following:


A Event number
B Event time
C Input line or comment of last event, where
applicable
D Clear button
E Enter button

Adding comments to an event


1 Enter the required comments using the on-
screen keyboard. A maximum of 30 characters
can be entered. The inserted text is displayed in
the input line (C).
2 Confirm with the Enter button (F) or by pressing
the rotary knob.

Clearing comments
 Touch the Clear button (D).

Instructions for use PulmoVista 500 SW 1.3n 83


Operation

Signal quality

Signal quality indicator Touching one of the following messages in the


header bar will cause the Signal check dialog to
PulmoVista 500 continuously determines the global open:
signal quality of the measured data. The signal – Restart calibration
quality is displayed in the header bar as bar graph. – Check electrode contact
– Check reference electrode
– Unstable electrode contact
High Medium Low – 15-electrode mode
– Low signal quality

Signal check
535

When the signal quality is classified as Low, NOTE


impedance waveforms in the End-insp. The electrode resistance depends on various con-
trend view, EELI trend view, and the ditions which may not be related to the information
Diagnostics view are displayed in darker gray displayed by PulmoVista 500. For this reason, the
color. determination of such resistances is not defined as
When one of the following messages is displayed, a measuring function in the sense of the
the signal quality is Low: Directive 93/42/EEC concerning medical devices.
– Safety function activated - Technical
– Safety function activated - Temperature The Signal check page is a graphical
– Restart calibration representation of electrode location and resistance
– Electromagnetic disturbance at each of the 16 electrodes, as well as at the
– Check patient cable connection reference electrode. Electrode resistance is
– Check electrode contact continuously monitored. The bargraph is updated
dynamically.
See "Troubleshooting" on page 109.
 Touch the Signal check... button in the main
The signal quality is an indicator for the reliability of menu bar.
the EIT data. In principle, always try to achieve a
high signal quality. A medium quality or, in rare
cases, also a low quality may be tolerated to obtain
useful information from PulmoVista 500. This
depends on:
– the experience of the user
– additionally available clinical information
– the possible contribution of EIT data to
therapeutic decisions
Even when the signal quality is high, artifacts
cannot be completely excluded, see "General
considerations" on page 147.

84 Instructions for use PulmoVista 500 SW 1.3n


Operation

Signal check If the resistance exceeds the defined limit of 300 


for the EIT electrodes and 400  for the reference
A electrode, the bargraph representing the affected
16 1
electrode is displayed in red. The message Check
15 2
14 3
electrode contact or Check reference electrode
13 4 is concurrently displayed.
12 5

11 6 PulmoVista 500 has been optimized for electrode


10
9 8
7
resistances of 30 to 200 Ohm and a reference
electrode resistance of 30 to 400 Ohm. Outside of
B this range the signal quality may be reduced.
600

500
Restarting calibration
400
Prerequisite: PulmoVista 500 is not in standby
300 D mode.
200 C When the message Restart calibration is
100 displayed, calibration is recommended.
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 R  Touch the Start button (E).
The following functions are not available during
E calibration:
– Record
534

– Mark event
The Signal check page displays the following: – Reference
A Electrode position
B Resistance of each electrode
C Resistance of reference electrode
D Defined limit of resistance
E Start button to restart calibration
The status of the electrodes (A) is indicated as
follows:

Status Explanation
Gray Skin-electrode contact is sufficient
for measurement to proceed
White Skin-electrode contact is unstable,
measurement will proceed but signal
quality may be impaired
Red Skin-electrode contact is insufficient
for measurement to proceed

Instructions for use PulmoVista 500 SW 1.3n 85


Operation

Standby mode

Switch to standby mode for the following actions: Activating standby mode
– Starting a new monitoring session
– Performing a device check 1 Touch the Start/ Standby... button in the main
– Changing the following settings in System menu bar.
Setup:
– Imported MEDIBUS or MEDIBUS.X 2 Touch the Standby button (B) on the
waveforms Start/Standby page (A).
– EIT settings
Start/Standby
– Language
– Access to service settings
– Dräger default settings A
– File handling for data recording (requires
the option ADAP)
– Simulation of patient data B
– Switching off PulmoVista 500

500

86 Instructions for use PulmoVista 500 SW 1.3n


Operation

Additional functions provided by the option ADAP

The option ADAP extends the functionality of the Stopping a recording


basic EIT software.
Prerequisite: The recording process is running.
 Touch the Record button in the main menu bar
Patient data once again.
Switching to standby mode or restarting the
The patient name is displayed in the header bar measurement also stops the recording process.
and on the Patient data page. When data are
recorded, the patient ID forms part of the file name.
 Enter patient data, see "Patient data" Data review
on page 106.
The Data review page enables the review of
previously recorded EIT data files.
Data recording  Touch the Data review... button in the main
menu bar.
Data can be recorded in single file mode, in
continuous mode, or in periodic mode. To select the Data review H
Record mode, see "Configuring data recording" MO Q S
on page 106.
I
When the device is not connected to mains power K
supply, the recording of data is limited by the level A 1
T N R
of available battery charge. J
K
Lack of available disk memory can limit recording of N R
B
data, see "Free disk space (J)" on page 108. J
K
N R
Starting a recording J
D C K
 Touch the Record button in the main menu bar. N R
E J
The progress of the recording is displayed in the F W K
header bar (A). G L U
V
540

The Data review page displays the following:


A
503

A Dynamic image – shows impedance changes in


a caudo-cranial image referenced to a fixed
Single mode Progress of the recording is in-
baseline
dicated as a percentage
Continuous Duration of the recording is dis-
mode played in minutes
Periodic mode Progress of the recording is in-
dicated as a percentage

Instructions for use PulmoVista 500 SW 1.3n 87


Operation

B Status image – as selected in the display – Stop – stops the play function and returns
settings on the Data review page the cursor to the beginning of the current
– Tidal image: Differential image of the end of page
inspiration compared to the beginning of – Next page , opens the next page of the
inspiration, which represents regional EIT file
distribution of impedance changes of the
M Global tidal variation TV global or global minute
last detected breath.
tidal variation MTV global – depending on the
– Minute image: Tidal images averaged over the
selected status image, expressed as the sum of
last minute or less, when the cursor is located
all regional relative impedance changes of the
within the first minute of the EIT data file.
entire status image (dimensionless)
C Set ROI... – to set the ROI, see "Setting ROIs"
N Regional tidal variation or minute tidal variation
on page 90
– depending on the selected status image,
D File... – to select a file, see page 89 expressed as the sum of regional relative
impedance changes within the defined ROI
E Patient data... – displays patient data
(dimensionless)
associated with the opened file, see page 89
O Global tidal variation TV global or global minute
F Display... – to change the display settings,
tidal variation MTV global – depending on the
see page 89
selected status image, always expressed as
G MEDIBUS data... – displays the MEDIBUS or 100 %
MEDIBUS.X parameters at the cursor position if
P Regional tidal variation or minute tidal variation
the selected file contains MEDIBUS or
– depending on the selected status image of the
MEDIBUS.X data. One MEDIBUS or
defined ROI, expressed as percentage
MEDIBUS.X parameter can be selected that is
superimposed onto the global impedance Q Global relative impedance change (compared
waveform, see page 90. to the baseline level) at the cursor position,
expressed as the sum of all regional relative
H File name of the selected EIT file
impedance changes within the entire displayed
I Global impedance waveform – displays the dynamic image (dimensionless)
relative impedance changes
R Regional relative impedance change at the
J Regional impedance waveforms – represent cursor position, expressed as the sum of
relative impedance changes of the defined ROI regional relative impedance changes within the
part of the displayed dynamic image
K Cursor
(dimensionless) that corresponds to the defined
L 5 navigation buttons: ROI within the status image
– Previous page , opens the previous
S MEDIBUS or MEDIBUS.X parameter
page of the EIT file
(displayed in green color), if selected on the
– Play – this moves the cursor through the
MEDIBUS data page
current page of the EIT file. In standby mode
the cursor speed is increased with repeated T Event marker
pressing.
U Indicator for the signal quality of the selected
Depending on the selected cursor speed,
EIT file
the recorded EIT files may replay faster or
slower than real-time data. V Event comment
– Pause – pauses the cursor at its current
W Auto rescale button
location. Play can be resumed by pressing
the Pause button a second time.

88 Instructions for use PulmoVista 500 SW 1.3n


Operation

Selecting the file


Patient data
All recorded EIT data are stored on the hard disk of D
the Cockpit in the following file structure:
– Folder E
– Subfolder F
– File
Prerequisite: The Data review page is open.
1 Touch the File... button.

File
A

542
The following patient data are displayed:
B – Patient ID (D)
– Short comment (E)
– Notes (F)
Patient data are entered and edited from System
C
setup > Data recording > Patient data. Patient
data that has been recorded as part of an EIT file
cannot be edited.
541

If no patient data are entered, see page 106.


2 Touch the button (A) to open the list of all
available folders. Select the folder using the
Changing display settings
touch screen or the rotary knob.
Initial display settings on the Data review page are
3 Touch the button (B) to open the list of all
the same as display settings on the Main view.
available subfolders. Select the subfolder using
Once display settings on the Data review page are
the touch screen or the rotary knob.
changed, they persist until the device is switched
4 Touch the button (C) to open the list of all off.
available files. Select the file by using the touch
Display settings made on the Data review page do
screen or the rotary knob.
not affect Main view settings.
Prerequisite: The Data review page is open.
Displaying patient data
Patient data are displayed on the Patient
data page.
Prerequisite: The Data review page is open.
 Touch the Patient data... button.

Instructions for use PulmoVista 500 SW 1.3n 89


Operation

1 Touch the Display... button. All MEDIBUS or MEDIBUS.X parameters at the


cursor position are displayed in the list (A) on the
Display MEDIBUS data page if the selected file contains
MEDIBUS or MEDIBUS.X data.
A 2 Touch the button (B) to open the list of all
B available MEDIBUS or MEDIBUS.X
parameters. Select the parameter to be
superimposed on the global impedance
waveform using the touch screen or the rotary
C knob.
D
E Setting ROIs
The initial ROI settings are the same on the Data
F review page and in the Main view. Once ROI
543

settings on the Data review page are changed,


The following display settings can be set: they persist until the device is switched off.
– Filter (A)
– Cut-off freq. [/min] (B) ROI settings on the Data review page do not affect
– Artifact filter (C) Main view settings.
– Status image (D)  Set the ROIs in the same manner as in the
– Display thoracic contour (E) Main view, see page 65.
– Time scale (F)
When ROIs are set to Layers or Quadrants, the
2 Set the display settings in the same manner as central positon of all the ROIs is indicated by "x" "y"
in System setup, see "Configuring the screen value. When the ROIs are set to Free, the central
layout" on page 94. position of each ROI is indicated.

Displaying MEDIBUS or MEDIBUS.X data


MEDIBUS or MEDIBUS.X data are displayed on
the MEDIBUS data page.
Prerequisite: The Data review page is open.
1 Touch the MEDIBUS data... button.

MEDIBUS data

A
547

90 Instructions for use PulmoVista 500 SW 1.3n


Operation

Ending operation

Switching off the system Canceling the Shut down


 Touch the Cancel button (C).
NOTE
In the case of voltage peaks in the mains power NOTE
supply, it may not be possible to switch off the de- A device shut-down can be forced by pressing the
vice. Contact DrägerService. on/off switch (A) for 4 seconds. This may result in
data loss. This type of shut-down should therefore
1 Switching PulmoVista 500 to standby mode: only be used if a normal shut-down is not possible.
Touch the Start/ Standby... button in the main
menu bar. Touch the Standby button on the
Start/Standby page. Removing the patient interface

Infinity C500 (MS18746) Prerequisite: PulmoVista 500 is switched off.


1 Remove the patient cable plugs from the patient
cable ports on the trunk cable.
A
2 Remove the reference electrode snap from the
reference electrode.

Infinity C500 (MK31500) 3 Remove the closure snap from the closure stud.
4 Open the electrode belt.
5 Lift the patient and remove the electrode belt
A from under the patient. Make sure that the
electrode belt does not snap back towards the
018

2 Press the On/Off key (A) on the Cockpit. patient. Ensure that the patient is lifted clear of
the electrode belt so that no skin damage can
PulmoVista 500 opens the Shut down device appear when removing the electrode belt.
dialog window.
6 Remove the patient cable from the electrode
Shut down device belt.
 If no further EIT measurements are intended for
B C the patient, remove the reference electrode. If
electrode gel or electrode spray has been used,
clean residue off the skin of the patient.
529

The OK button (B) is preselected.


3 Confirm with the rotary knob.

Instructions for use PulmoVista 500 SW 1.3n 91


Operation

Disconnecting PulmoVista 500 from


a Dräger device

When the transfer of MEDIBUS or MEDIBUS.X


data is no longer required, the MEDIBUS cable
must be removed from PulmoVista 500 and the
Dräger device in use.
 To remove the MEDIBUS cable, see page 47.

92 Instructions for use PulmoVista 500 SW 1.3n


Configuration

Configuration

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Configuring the screen layout. . . . . . . . . . . . 94


Configuring the display . . . . . . . . . . . . . . . . . . . 94
Configuring the MEDIBUS import. . . . . . . . . . . 98
Configuring the parameter selection. . . . . . . . . 99

Configuring EIT settings . . . . . . . . . . . . . . . . 100


Frame rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Operating frequency . . . . . . . . . . . . . . . . . . . . . 101

Configuring the system . . . . . . . . . . . . . . . . . 102


Selecting country-specific settings . . . . . . . . . . 102
Service pages. . . . . . . . . . . . . . . . . . . . . . . . . . 103
Simulating patient data . . . . . . . . . . . . . . . . . . . 105

Configuring data recording . . . . . . . . . . . . . . 106


Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
File handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Instructions for use PulmoVista 500 SW 1.3n 93


Configuration

Overview

This chapter describes the system setup functions. Changes to system setup settings become
The System setup dialog window provides the effective immediately. Changes to settings are
user with the following setup pages: retained after switching off PulmoVista 500. All
– Screen layout settings can be set to factory defaults on the
– EIT settings Service page.
– System
The Product specific page in the Service dialog
– Data recording (requires the option ADAP)
window is protected by an access code.

Configuring the screen layout

The Screen layout page consists of the Overview, System setup


Display, MEDIBUS import, and Parameter
selection subpages.
A

Configuring the display C L M N


1 Touch the System setup... button in the main
D O P B
menu bar to open the Screen layout page (A). Q
2 Select the Display (B) tab.
E
F R S
G T U
H
I

J V
K W X
507

94 Instructions for use PulmoVista 500 SW 1.3n


Configuration

On the Display page, the user can change the


following settings:

Item Parameters Settings


(C) Filter Off (L), Low pass (M), Band pass (N)
(D) Cut-off freq. [/min] Cut-off frequency for low-pass filter (O),
upper cut-off frequency for band-pass filter (P),
lower cut-off frequency for band-pass filter (Q)
(E) Artifact filter On, Off
(F) Status image Tidal (R), Minute (S)
(G) Full-screen image and Ptp analysis Dynamic image (T), Status image (U)
view
(H) Display thoracic contour On, Off
(I) Display contour of ventilated area On, Off
(J) Time scale Displayed duration of the impedance waveform
(V)
(K) Baseline update Breath (W), Time scale (X)

Instructions for use PulmoVista 500 SW 1.3n 95


Configuration

Filter and cut-off frequency settings


These settings can be used to display impedance
changes below a particular frequency (low pass) or
within a particular frequency range (band pass).
Filter settings determine the nature of impedance
changes reflected in the displayed data as changes
due to ventilation, cardiac and high frequency noise
artifacts can be separated.
Filter and cut-off frequency settings only affect the
display of data, not data recording. Band pass
filtering only affects the display of data in the Main
and Full-screen image views.
The following table illustrates the effect of
combinations of filter and cut-off frequency
settings.

Filter setting Cut-off frequency setting Description


(/min)
Off (I) – Impedance changes of all frequen-
cies are displayed.
Signals from high-frequency noise
may be included.
Low pass (J) Below the heart rate but above Ventilation-related impedance
the respiratory rate, e.g., heart changes are displayed.
rate less 10
High-frequency noise signals and
cardiac-related impedance changes
are attenuated.
Above the heart rate, e.g., heart Ventilation- and cardiac-related im-
rate plus 20 pedance changes are displayed.
High-frequency noise signals are at-
tenuated.
Band pass (K) The low cut-off frequency must Cardiac-related impedance changes
be less than the heart rate, the are displayed.
(Requires ADAP)
upper cut-off frequency must be
High-frequency noise signals and
Numeric values are not dis- above the heart rate, e.g., low
ventilation-related impedance chang-
played when band pass filter- frequency: heart rate less 10, up-
es are attenuated.
ing is activated. per frequency: Heart rate plus 10

96 Instructions for use PulmoVista 500 SW 1.3n


Configuration

Setting the filter Displaying the thoracic contour


 Touch the relevant button for the filter. This function determines if the thoracic contour is
displayed. The thoracic contour is a schematic
Setting the cut-off frequency
representation of the thorax of the patient with a
1 Touch the relevant button for the frequency. reference to the spine.
2 Set the value by turning the rotary knob and  Touch the On or Off button.
press to confirm.
Frequency settings may be changed regardless of Displaying the contour of the ventilated area
the selected filter mode. This enables the
This configuration defines whether a contour is
frequency settings to be customized before
displayed that separates the ventilated area (blue
changing the filter modes.
or white) from the non-ventilated area (black).
The contour surrounds the area of the smallest still
Configuring the artifact filter
detectable and displayed impedance change (blue)
This configuration defines whether interferences and thus the ventilated area. Areas with small
are dampened in the displayed impedance impedance changes which were previously
waveforms. However, it does not affect the data displayed as non-ventilated (black) may now be
recording. displayed as ventilated (blue to white). This may
now also cause a significant change of the contour.
 In the row Artifact filter (E) touch the On or Off
button. Clinical and therapy-related influences must be
taken into account when interpreting the contour. A
change of the contour alone should not lead to the
Configuring the status image
conclusion that clinically relevant changes have
The status image is either a tidal image or a minute occurred in the distribution of ventilation.
image. The tidal image represents the regional
In the Main and Full-screen image views, the
distribution of the impedance changes due to tidal
contour surrounds in the dynamic image the area
ventilation of the last detected breath. The minute
ventilated during the last breath.
image represents the regional distribution of the
impedance changes due to tidal ventilation of the In the End-insp. trend and EELI trend views, on
spontaneous or mechanical breaths of the last the other hand, the contour surrounds in the two
minute. status images and in the differential images the
area that was at least temporarily ventilated during
 Touch the Tidal button (R) to display a tidal
the selected time scale.
image or the Minute button (S) to display a
minute image.  In the row Display contour of ventilated
area (I) touch the On or Off button.
Configuring the Full-screen image and Ptp In the Diagnostics view, the contour surrounds in
analysis view all displayed images the area that was at least
temporarily ventilated within the selected sections.
The selected image is shown in large format in the
Full-screen image view. The other image is shown
smaller.
Only the selected image is shown in the Ptp
analysis view.
 Touch the Dynamic image (T) or Status
image (U) button.

Instructions for use PulmoVista 500 SW 1.3n 97


Configuration

Setting the time scale 1 Touch the System setup... button in the main
menu bar to open the Screen layout page (A).
The time scale setting determines the duration of
the impedance waveforms in the Main view and the 2 Select the MEDIBUS import (B) tab.
Full-screen image view.
System setup
1 Touch the button (V) in the row Time scale (J).
2 Select the value by turning the rotary knob and
press to confirm.
A
The available time scale settings vary with the C
selected frame rate.
D
Baseline update B
The baseline update setting defines at which E
interval the baseline of the impedance waveforms
is updated.
 Touch the Breath button (W) to update the F
baseline after each detected breath.
G
G
 Touch the Time scale (X) button to update the
baseline each time the cursor passes the zero G
position of the time scale.
For more details, see "Definition of baseline

508
frames" on page 159. PulmoVista 500 displays the MEDIBUS or
MEDIBUS.X settings (C), the selected baud rate
(D) of PulmoVista 500 and the model of the
Configuring the MEDIBUS import connected Dräger device (E).

The parity and stop bit settings for COM 1 are fixed On the MEDIBUS import page, the user can
on PulmoVista 500 and must be adjusted on the change the following settings:
connected Dräger device. The value 19200 or 9600
can be selected as the baud rate, which must be Imported MEDIBUS waveforms (F)
configured accordingly for PulmoVista 500 and the
connected Dräger device. To connect the Dräger To select which MEDIBUS or MEDIBUS.X
device, see "Preparation for using the MEDIBUS or waveforms are stored with EIT data, proceed as
MEDIBUS.X protocol" on page 46. Use the values follows:
below to configure the COM settings on the Dräger 1 Touch the button (G) to open the parameter
device according to its instructions for use. selection list.

NOTE 2 Select a parameter.


In order for the setting of a new baud rate to be
adopted, PulmoVista 500 must be restarted.

Baud rate 19200 or 9600


Parity Even
Stop bit 1

98 Instructions for use PulmoVista 500 SW 1.3n


Configuration

Configuring the parameter selection Trend display (E)


This setting defines which three MEDIBUS,
System setup MEDIBUS.X, or PressurePod parameters are
displayed as trend data. If available, all MEDIBUS,
MEDIBUS.X, and PressurePod parameters are
A stored during recording, regardless of the displayed
parameter. This setting applies to the End-insp.
trend and EELI trend views.
C D 1 Touch the button (F) to open the parameter
selection list.
2 Select a parameter.
B
E F Lung mechanics (G)

F This setting defines whether the Compliance or


Elastance parameter is displayed on the Static
F analysis page.

D
G
564

On the Parameter selection page, the user can


change the following settings:

Display of imported waveforms (C)


With this setting, an imported waveform
superimposed on the global impedance waveform
can be displayed in the Main, Full-screen image,
and Ptp analysis views.
1 Touch the button (D) to open the parameter
selection list.
2 Select a parameter.

Instructions for use PulmoVista 500 SW 1.3n 99


Configuration

Configuring EIT settings

1 Touch the System setup... button in the main Frame rate


menu bar.
2 Touch the EIT settings (A) tab. The frame rate is the frequency at which dynamic
images are generated.
System setup Available settings: 10, 15, 20, 30 and additionally
40, 50 for the option ADAP.
A
Changing frame rate
B Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the Frame rate [Hz] button (B).
2 Select the value by turning the rotary knob and
press to confirm.
Increasing the frame rate increases the temporal
C resolution but may also cause a reduction in the
D signal quality. Recording EIT data at high frame
rates may result in large files (up to 15 MB per
minute at a frame rate of 50 Hz). Frame rates
>30 Hz are only recommended for analysis of
cardiac-related impedance changes.
E
If the reference function is activated, changing the
F frame rate deletes the reference data.
G H
Noise spectrum
513

On the EIT settings page, the user can change the A noise spectrum analysis is conducted during the
following settings: calibration phase. The noise spectrum is displayed
– Frame rate [Hz] (B) in the diagram (C).
– Operating frequency [kHz] (F)
– Adjustment of operating frequency (G), (H)

100 Instructions for use PulmoVista 500 SW 1.3n


Configuration

Operating frequency

The operating frequency is displayed in the field (F)


and as a dashed vertical line in the diagram (D).

Adjustment of operating frequency


Automatic:
PulmoVista 500 determines the optimal operating
frequency based on automatic spectrum analysis
during the calibration phase.
 Touch the Auto button (G).
Manual:
This function requires the ADAP option.
If adjustment of frequency is set to Manual, the
horizontal slider (E) can be used to adjust the
operating frequency between 80 and 130 kHz.
1 Touch the Manual button (H).
2 Set the horizontal slider (E) by turning the rotary
knob or by touching the slider. Press the rotary
knob to confirm.
Set the operating frequency to a value within a
frequency range where there is a low level of
background noise.

Instructions for use PulmoVista 500 SW 1.3n 101


Configuration

Configuring the system

The System page consists of the following Language


subpages:
Prerequisite: PulmoVista 500 is in standby mode.
– Overview
– Country 1 Touch the button (F) to open the language
– Service selection.
– Simulation
2 Select the country-specific language.

Selecting country-specific settings Date and time


Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the System setup... button in the main
menu bar. PulmoVista 500 displays the current date and time
in the Date and time (D) lines.
2 Touch the System (A) tab.
1 Touch the relevant buttons for year, month, day,
3 Touch the Country (B) tab. hour, and minute.
System setup 2 Select the value by turning the rotary knob and
press to confirm.

A 3 Touch the Apply button (G) to activate the


settings.

C F B Airway pressure unit


The airway pressure unit of displayed MEDIBUS
data can be selected.
D  Touch the mbar (H) or cmH2O (I) button.
G

E H I
514

On the Country page, the user can change the


following settings:
– Language (C)
– Date and time (D)
– Airway pressure (E)

102 Instructions for use PulmoVista 500 SW 1.3n


Configuration

Service pages Dräger default settings


Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the System setup... button in the main
menu bar. 1 Touch the Dräger default button (E).

2 Touch the System (A) tab. 2 Press the rotary knob to confirm.

3 Touch the Service (B) tab. The following system settings are reset to factory
settings:
System setup
Parameters Setting

A Filter Off
Status image Tidal image
Full-screen image and Ptp anal- Status image
ysis view
C Display of thoracic contour On
B Time scale 30 s
Frame rate 20 Hz
Adjustment of operating fre- Automatic
quency
D Record mode Continuous
MEDIBUS baud rate 19200
File length for recording 30 s
Saved MEDIBUS or Paw, Flow, Vol.
MEDIBUS.X waveforms
E MEDIBUS or MEDIBUS.X vol- Off
ume waveform superimposed
515

onto the global impedance


PulmoVista 500 displays the following product waveform
identification data in the (C) field: MEDIBUS or MEDIBUS.X data PEEP
– Product name in the trend view
– Part number PIP
– SW version VT
– Serial number Display contour of ventilated Off
On this page, the user has the following options: area
– Open the Service dialog window (D) Artifact filter Off
– Change to Dräger default settings (E)
PressurePod measurements Off

Instructions for use PulmoVista 500 SW 1.3n 103


Configuration

Accessing the Service dialog window Page Applications


Prerequisite: PulmoVista 500 is in standby mode Prerequisite: The Service dialog window is open.
and the System setup > System > Service page
1 Touch the Applications (H) tab.
is open.
1 Touch the Enter menu button (D). Service

Service
H
F G H

J K L

546
The list of installed applications is displayed (L).
Installing applications
Only use SIM cards and USB-SIM card readers
545

The Service dialog window consists of the supplied by Dräger.


following pages: 1 Insert the SIM card into the USBSIM card reader.
– System information (F)
– Product specific (G) 2 Insert the USBSIM card reader into the USB
– Applications (H) port on the Cockpit.
3 Touch the Install button (K).
Page System information
4 Select the application from the list (J) using the
The System information page is preselected and rotary knob and press to confirm. If only one
contains information about the software versions of application is available, there is no need to
the installed system components (I). select the application.
Page Product specific 5 To assure correct installation of the application,
This page is protected by an access code. wait at least 20 seconds before removing the
USB SIM card reader.
Prerequisite: The Service page is open.
6 If applicable, install further applications (repeat
1 Touch the Product specific (G) tab. steps 3, 4, and 5).
2 Enter the access code. 7 When all applications are installed, restart the
device.
8 The installed application is displayed in the list (L).

104 Instructions for use PulmoVista 500 SW 1.3n


Configuration

Simulating patient data

In the simulation mode, previously recorded EIT To activate simulation mode, proceed as follows:
files can be displayed in all views. The simulation
1 Touch the relevant buttons (E), (F), (G) or (H)
mode can be used for demonstration purposes. If
to open the list of available folders, subfolders,
patient data are changed in the simulation mode,
and files. Select a folder, a subfolder, and the
e.g., for demonstration purposes, these changes
EIT files that are to be used for the simulation.
will not affect recorded data.
Selecting folders and subfolders requires the
Prerequisite: PulmoVista 500 is in standby mode.
option ADAP.
1 Touch the System setup... button in the main
Without the ADAP option, a folder and a
menu bar.
subfolder are preselected. The relevant (E) and
2 Touch the System (A) tab. (F) buttons are inactive. A preinstalled example
EIT file for demonstration purposes can be
3 Touch the Simulation (B) tab.
selected using the (G) button.
System setup 2 Touch the On button (C) and press the rotary
knob to confirm.
In the header, Simulation is displayed.
A
To stop the simulation mode, proceed as follows:
1 Touch the Start/ Standby... button in the main
C D menu bar. Touch the Standby button on the
Start/Standby page.
2 Touch the System setup... button in the main
E B menu bar.
3 Touch the System (A) tab.
4 Touch the Simulation (B) tab.
F 5 Touch the Off button (D).

H
553

Instructions for use PulmoVista 500 SW 1.3n 105


Configuration

Configuring data recording

CAUTION System setup


Risk of data protection violation
Only use identification numbers for patient data. A
Do not enter confidential information such as the
patient's name or date of birth. C F
D F B
Data recording requires the option ADAP.
E F
The Data recording page consists of the
Overview, Patient data, and File handling
subpages.
G

H
Patient data

1 Touch the System setup... button in the main


menu bar.
2 Touch the Data recording (A) tab. I J K L
3 Touch the Patient data (B) tab. M
N

516
On the Patient data page, the user can change the
following data and settings:
– Patient ID (C)
– Short comment (D)
– Notes (E)
– Record mode (I)
– File length (M)
– Interval for periodic recording (N)

Entering or editing patient data


 Touch the Edit button (F) next to the field to be
edited to display the on-screen keyboard. Enter
the patient data (up to 20 characters for each
field, up to 50 characters for the Notes field).

106 Instructions for use PulmoVista 500 SW 1.3n


Configuration

When data is recorded, file names are The directory and the file name are displayed in the
automatically created using the following format: (G) field. If either the patient ID or short comment is
– Folder: current date changed, a new subfolder and a new file name is
– Subfolder: Patient ID_Short comment created after the first recording.
– File: Patient ID_Short comment_Incremental
If no Patient ID or no Short comment is entered,
counter
the subfolder and the file name are both
automatically labeled ID_SC.
The incremental counter depends on the record
mode.

Record mode File name Description


Single ID_SC_XX XX increments each time the recording function is
started
Cont. ID_SC_XX_YYY XX increments each time the recording function is
started
YYY increments with each new file
Periodic ID_SC_XX_YY XX increments each time the recording function is
started
YY increments with each new file

Clearing data  Touch the Single (J), Cont. (K), or Periodic (L)
button.
 Touch the Clear data button (H) to clear the text
fields.
File length
Data recording settings 1 Touch the File length button (M).
The record mode and the file length can be 2 Select the value by turning the rotary knob and
adjusted. press to confirm.
The record mode can be set as follows: Be aware that the time taken to open files increases
– Single – Single file mode to record a single file with the size of the file.
of a selected file length when the Record button
in the main menu bar is touched.
Interval for periodic recording
– Cont. – Continuous mode to record multiple
continuous files of a selected file length as long 1 Touch the button for setting the interval (N).
as the Record button in the main menu bar is
2 Select the value by turning the rotary knob and
active.
press to confirm.
– Periodic – Periodic mode to record files of a
selected file length at intervals as long as the
Record button in the main menu bar is active.

NOTE
A continuous recording is automatically ended
after 24 hours.

Instructions for use PulmoVista 500 SW 1.3n 107


Configuration

File handling The File handling page contains the following:


– Folder (C)
All recorded EIT data are stored on the hard disk of – Subfolder (D)
the Cockpit in the following file structure: – File (E)
– Folder – Properties of the folder, subfolder, or file (F)
– Subfolder – Size of the file
– File – Number of the contained subfolders or files
– Date of the file record
Folders, subfolders, and files can be deleted or – Button to open the list of all folders,
copied to a connected USB storage medium. subfolders, or files (G)
Prerequisite: PulmoVista 500 is in standby mode. – Button Copy to USB (H)
– Button Delete (I)

Accessing the File handling page


Deleting a folder, subfolder, or file
1 Touch the System setup... button in the main
menu bar. 1 Touch the relevant button (G) to open the list
of all available folders, subfolders, or files.
2 Touch the Data recording (A) tab. Select a folder or subfolder or a single file.
3 Touch the File handling (B) tab. 2 Touch the relevant Delete button (I) and confirm
by pressing the rotary knob.
System setup

Copying a folder, subfolder, or file


A
1 Connect a USB storage medium to the left or
G right USB port on the Cockpit.
C H
2 Touch the relevant button (G) to open the list
F I of all available folders, subfolders, or files.

G B Select a folder or subfolder or a single file.

D H 3 Touch the relevant Copy to USB button (H) and


I confirm by pressing the rotary knob.
F
G Free disk space (J)
E H
A portion of the hard disk drive is reserved for EIT
F I data. This parameter indicates the available space
in this reserved section.
J
K Free USB space (K)
This parameter indicates the available space on the
517

connected USB storage medium.

After data export to a USB storage medium


Wait until message "Copied files: X" is shown
before removing the USB storage medium.

108 Instructions for use PulmoVista 500 SW 1.3n


Troubleshooting

Troubleshooting

Message – Cause – Remedy . . . . . . . . . . . . . 110

Instructions for use PulmoVista 500 SW 1.3n 109


Troubleshooting

Message – Cause – Remedy

Messages are displayed in the message field of the


header bar in hierarchical order.
If several messages occur simultaneously, the
message field displays the highest-priority
message.
In the following table, the messages are listed in
alphabetical order. If a message occurs, the table
helps to identify causes and remedies. The different
causes and remedies must be worked through in
the order listed until the condition has been
resolved.

Prio Alarm Cause Remedy


090 15-electrode mode During the start of measure- In the 15-electrode mode, mon-
ment, there was insufficient itoring can be continued when it
contact between one elec- is not possible to locate all 16
trode and the skin. Images electrodes against the skin,
are generated using the 15- e.g., due to wound dressings.
electrode mode. Spatial resolution may be de-
creased in the region of the in-
active electrode. Interpretation
of EIT data is still possible.
To reestablish the 16-electrode
mode, touch the "Signal
check..." button to identify the
electrode with unstable con-
tact. After improving electrode
contact, touch the "Start" but-
ton.
Restore electrode contact or
decrease electrode resistance
as described in these instruc-
tions for use.

110 Instructions for use PulmoVista 500 SW 1.3n


Troubleshooting

Prio Alarm Cause Remedy


160 Check electrode contact The resistance of at least Touch the "Signal check..." but-
one electrode is too high. ton to check the resistance of
the electrodes. Use the "Signal
check" dialog window to evalu-
ate the effectiveness of adjust-
ments.
Check if the electrode has good
contact with the skin. Consider
applying electrode gel to all
electrodes with insufficient or
unstable contact.
Press the electrode gently
against the skin. Make sure
that the patient cable is secure-
ly attached to all electrodes.
The patient cable was not Connect the patient cable cor-
connected correctly to the rectly to the electrode belt as
electrode belt. described in these instructions
for use.
The patient cable was not Connect the patient cable cor-
connected correctly to the rectly to the trunk cable as de-
trunk cable. scribed in these instructions for
use.
The trunk cable was not Connect the trunk cable cor-
connected correctly to the rectly to the EIT module as de-
EIT module. scribed in these instructions for
use.
Restart the measurement. If
the condition persists, replace
the electrode belt. If the condi-
tion persists, perform the de-
vice check. If the device check
passes, replace the patient ca-
ble. If the device check fails, re-
place the trunk cable. If the
condition persists, call Dräger-
Service.
120 Check patient cable con- The patient cable was not Connect the patient cable cor-
nection connected correctly to the rectly to the electrode belt as
electrode belt. described in these instructions
for use.

Instructions for use PulmoVista 500 SW 1.3n 111


Troubleshooting

Prio Alarm Cause Remedy


150 Check reference elec- The resistance of the refer- Touch the "Signal check..." but-
trode ence electrode is too high. ton to check the resistance of
the reference electrode. Use
the "Signal check" dialog win-
dow to evaluate the effective-
ness of adjustments.
If the maximum resistance is
displayed, check first if the pa-
tient cable was connected to
the reference electrode and if
the reference electrode was
applied to the patient.
Check if the reference elec-
trode has good contact with the
skin. Press the reference elec-
trode gently against the skin.
Restart the measurement. If
the condition persists, replace
the reference electrode. If the
condition persists, call Dräger-
Service.
200 Device failure Internal communication fail- Restart the device. If the mes-
ure. Cockpit or EIT module sage appears again, call
is faulty. DrägerService.
Electrocautery or electro-
surgery also may cause this
message.
040 Electrode belt not detect- The closure snap on the pa- Connect the closure snap of
ed tient cable was not connect- the patient cable to the closure
ed correctly after the elec- stud on the electrode belt after
trode belt was closed. the electrode belt is closed.

112 Instructions for use PulmoVista 500 SW 1.3n


Troubleshooting

Prio Alarm Cause Remedy


105 Electromagnetic distur- Electromagnetic distur- Investigate which devices in
bance bances have been detected the patient vicinity cause distur-
during the measurement. bances. If possible, deactivate
the source of the disturbance
while performing measure-
ments or increase the distance
between the source of the dis-
turbance and the patient.
Activate the artifact filter.
If no disturbances are visible in
the waveforms and images, the
measurement can be contin-
ued.
100 Low signal quality The signal quality is low. Touch the "Signal check..." but-
ton to check the resistance of
the electrodes. Use the "Signal
check" dialog window to evalu-
ate the effectiveness of adjust-
ments.
If necessary, decrease the re-
sistance as described in these
instructions for use. Restart the
measurement.
If the condition persists, set the
frame rate to 10 Hz. Restart the
measurement. If the signal
quality improves, the frame
rate can be increased again
gradually.
Restart the measurement. Ob-
serve the signal quality.
If the signal quality does not im-
prove at a frame rate of 10 Hz,
perform a device check.
If the device check passes, re-
place the electrode belt and re-
start the measurement. If the
condition persists, replace the
patient cable and restart the
measurement.
If the device check fails, call
DrägerService.

Instructions for use PulmoVista 500 SW 1.3n 113


Troubleshooting

Prio Alarm Cause Remedy


050 Patient cable not detected The patient cable is not con- Connect the patient cable to
nected to the trunk cable. the trunk cable before starting
the measurement. If the condi-
The patient cable is faulty.
tion persists, replace the pa-
tient cable.
130 Patient cable or trunk ca- The patient cable or the Perform device check. If the
ble faulty trunk cable is faulty. device check passes, replace
the patient cable. If the device
check fails, replace the trunk
cable.
080 Period of use of electrode The recommended period If signal quality during EIT mea-
belt elapsed of use of the electrode belt surement is adequate, monitor-
has elapsed. ing can be continued. If signal
quality during EIT measure-
ment is low, consider replacing
the electrode belt.
038 Ready for device check The patient cable plugs are Perform the device check. Af-
plugged into the test con- terwards remove the patient
nectors. The device is cable plugs from the test con-
ready to start the device nectors.
check.
110 Restart calibration A significant change in one Open the "Signal check" dialog
of the following conditions window and restart the calibra-
has occurred: Electrode re- tion. If this message has likely
sistance, signal quality, been caused by pacemaker
body position. signals, electrocautery, or elec-
trosurgery, no remedy is re-
Pacemaker signals, electro-
quired.
cautery, or electrosurgery
also may cause this mes-
sage.
190 Safety function activated - The safety function was ac- Restart the device. If the mes-
Technical tivated for technical rea- sage appears again, call
sons. DrägerService.
180 Safety function activated - The safety function was ac- Make sure that the ventilation
Temperature tivated because the tem- slots of the EIT module are not
perature in the EIT module covered or occluded. Let the
is too high. device cool down. Restart the
device. If the message appears
again, call DrägerService.

114 Instructions for use PulmoVista 500 SW 1.3n


Troubleshooting

Prio Alarm Cause Remedy


170 Temperature high The temperature in the EIT Make sure that the ventilation
module is too high. slots of the EIT module are not
covered or occluded. If the
message does not disappear,
switch off the device and let it
cool down.
Restart the device. If the mes-
sage appears again, call
DrägerService.
060 Trunk cable not detected The trunk cable is not con- Connect the trunk cable to the
nected to the EIT module. EIT module before starting the
measurement. If the condition
The trunk cable is faulty.
persists, replace the trunk ca-
ble.
140 Unstable electrode con- The variation in the resis- Touch the "Signal check..." but-
tact tance of at least one elec- ton to identify all electrodes
trode is too high. with poor contact. Use the "Sig-
nal check" dialog window to
evaluate the effectiveness of
adjustments.
Restart the measurement. If
the condition persists, replace
the electrode belt and restart
the measurement. If the condi-
tion persists, replace the pa-
tient cable and restart the mea-
surement.
Restart the measurement. If
the condition persists, replace
the electrode belt. If the condi-
tion persists, replace the pa-
tient cable. If the condition per-
sists, call DrägerService.
070 Wrong patient cable The size of the patient cable Use the correct patient cable
and of the electrode belt in size for the electrode belt in
use do not match. use.

If technical messages continue to display which are


not related to known adverse conditions or to the
measurement set-up, perform a device check.

Instructions for use PulmoVista 500 SW 1.3n 115


This page has been left blank intentionally.

116 Instructions for use PulmoVista 500 SW 1.3n


Reprocessing

Reprocessing

Safety information . . . . . . . . . . . . . . . . . . . . . 118

Information on reprocessing. . . . . . . . . . . . . 119

Classifications for reprocessing. . . . . . . . . . 119


Classification of medical devices . . . . . . . . . . . 119
Classification of device-specific components . . 119

Before reprocessing. . . . . . . . . . . . . . . . . . . . 120


Patient-specific accessories and
consumables . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Device-specific components. . . . . . . . . . . . . . . 121

Validated reprocessing procedures . . . . . . . 121


Overview of the reprocessing procedures of
the components . . . . . . . . . . . . . . . . . . . . . . . . 121
Surface disinfection with cleaning . . . . . . . . . . 122
Storage and transport. . . . . . . . . . . . . . . . . . . . 123

Other agents and reprocessing


procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

After reprocessing . . . . . . . . . . . . . . . . . . . . . 125


Assembling and fitting device-specific
components . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Preparation before next use of device . . . . . . . 125

Instructions for use PulmoVista 500 SW 1.3n 117


Reprocessing

Safety information

WARNING WARNING
Risk due to inappropriately reprocessed prod- Risk of electric shock and of device malfunc-
ucts tion
Reusable products must be reprocessed, oth- Penetrating liquid may cause malfunction of
erwise there is an increased risk of infection. or damage to the device, which may endanger
– Follow the infection prevention policies the patient.
and reprocessing regulations of the
Do not immerse or rinse the EIT system or its
health-care facility.
components (e.g., patient interface, Cockpit,
– Follow the national infection prevention cables, USB storage media) in liquids. During
policies and reprocessing regulations. surface disinfection make sure that no liquids
– Use validated procedures for reprocess- enter the device.
ing.
– Reprocess reusable products after every If a liquid is accidentally spilled on the device,
use. disconnect the device from the power source.
– Follow the manufacturer's instructions for Contact service personnel regarding the con-
cleaning agents, disinfectants, and repro- tinued safety of the device before putting it
cessing devices. back into operation.

CAUTION WARNING
Risk due to faulty products Do not use sharp tools or abrasives. Do not
immerse electrical connectors in water or oth-
Signs of wear, e.g., cracks, deformation, discolor- er liquids. Avoid the accumulation of liquid at
ation, or peeling, may occur with reprocessed the edge of the screen as this may damage the
products. device.
Check the products for signs of wear and replace
them if necessary. CAUTION
Do not clean the Cockpit using an alcoholic solu-
WARNING tion. Such solutions may damage the Cockpit.
Risk of electric shock
CAUTION
Do not sterilize PulmoVista 500 and its acces-
Risk of damage to the touchscreen
sories as this may damage the insulation of
cables. Instead, perform the cleaning proce- Do not spray the cleaning liquid directly on the
dures described in the instructions for use. touch screen. The cleaning liquid must be applied
to a cloth or tissue before cleaning the surface.
WARNING
Risk of electric shock NOTE
Do not clean the touch screen of the Cockpit while
Do not disconnect the system cables. If nec-
monitoring a patient. Before cleaning, take the de-
essary, contact service personnel.
vice out of operation.

118 Instructions for use PulmoVista 500 SW 1.3n


Reprocessing

Information on reprocessing

Follow the national infection prevention policies Follow the infection prevention policies and
and reprocessing regulations. reprocessing regulations of the health-care facility
(e.g., concerning the reprocessing cycles).

Classifications for reprocessing

Classification of medical devices

The classification depends on the intended use of


the medical device. The risk of infection
transmission through the application of the product
to the patient without proper reprocessing is the
basis of the Spaulding classification.

Classification Explanation
Non-critical Components that come into contact only with skin that is intact
Semi-critical Components that carry breathing gas or come into contact with mucous mem-
branes or pathologically altered skin
Critical Components that penetrate skin or mucous membranes or come into contact with
blood

Classification of device-specific components

The following classification is a recommendation


from Dräger.

Non-critical
– Device surface including screen
– Patient interface
– Trolley with modules

Instructions for use PulmoVista 500 SW 1.3n 119


Reprocessing

Before reprocessing

Observe before disassembly


1 Switch off the device and all devices connected
to it.
2 Disconnect all power plugs.

Patient-specific accessories and consumables

The patient-specific accessories and consumables


must be removed from the device and, if necessary,
disassembled.
Reusable products:
 If the reusable product has its own instructions
for use, perform reprocessing in accordance
with the separate instructions for use.
 If no separate instructions for use are available
for the reusable product, perform reprocessing
in accordance with the instructions in these
instructions for use.
Disposable products:
 Dispose of the disposable products.

120 Instructions for use PulmoVista 500 SW 1.3n


Reprocessing

Device-specific components

The device-specific components must be removed Disassembling the patient interface


from the device and, if necessary, disassembled.
1 Disconnect the trunk cable from the patient
cable.
Removing the trunk cable
2 Remove the patient cable from the electrode
 Remove the trunk cable from the trunk cable belt.
port of the EIT module.

Validated reprocessing procedures

Overview of the reprocessing procedures of the components

Components Surface disin- Manual cleaning fol- Machine cleaning Description of the
fection with lowed by disinfection with thermal dis- procedure
cleaning by immersion infection
Device surface and Yes No No See page 122
trolley
Patient interface Yes No No

Instructions for use PulmoVista 500 SW 1.3n 121


Reprocessing

Surface disinfection with cleaning

Components:
– Device surface and trolley

Surface disinfectant Manufacturer Concentration Contact time


Dismozon pur/plus BODE Chemie 1.6 % 15 min
Oxycide Ecolab USA 2.3 % 5 min

Components:
– Patient interface

Surface disinfectant Manufacturer Concentration Contact time Additional Informa-


tion
Mikrobac tissues (disin- BODE Chemie Ready-to-use / 1 min For effective cleaning
fectant wipes) ready-to-use and disinfection, use
wipes at least two disinfec-
tant wipes and wipe
them back and forth at
least 3 times.

Prerequisites: Surface disinfection


– The surface disinfectant has been prepared in
3 Wipe cleaned surfaces again to visibly wet all
accordance with the manufacturer's instructions.
surfaces to be disinfected with surface
– The manufacturer's instructions, e.g., regarding
disinfectant.
shelf life or application conditions, are
observed. 4 Wait for the surface disinfectant contact time.
– An uncontaminated, lint-free cloth soaked in
5 At the end of the contact time, moisten a new,
surface disinfectant is used for the cleaning
uncontaminated and lint-free cloth with water
surface disinfection.
(at least drinking water quality).
WARNING 6 Wipe all surfaces until no remains of the surface
Risk due to penetrating liquid disinfectant, such as foam residues or streaks,
are visible.
Penetrating liquid may cause the following:
– Damage to the device 7 Wait until the surfaces are dry.
– Electric shock 8 Check the surfaces for visible damage and, if
– Device malfunctions necessary, replace the product.
Ensure that no liquid penetrates the device.
Supplementary information
Cleaning Dräger recommends disposing of the following
1 Wipe off obvious soiling with a disposable cloth components if they are very dirty or heavily
soaked in surface disinfectant. Dispose of the contaminated:
cloth. – Trunk cable
– Electrode belt
2 Wipe all surfaces. After that, there must no – Patient cable
longer be any soiling visible.

122 Instructions for use PulmoVista 500 SW 1.3n


Reprocessing

Storage and transport

After reprocessing, there are no special All further information on storage and transport
requirements for storage and transport of the included in the accompanying documents must be
product. However, the following must be observed: observed.
– Store dry and free of dust
– Avoid recontamination and damage during
transport

Other agents and reprocessing procedures

Disinfectants

Use nationally approved disinfectants suitable for


the respective reprocessing process and the
intended application.

Surface disinfectants
The manufacturers of the surface disinfectants
have verified at least the following spectra of
activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Follow the manufacturer's instructions for surface
disinfectants.
The following surface disinfectants were
compatible with the material of the device surface
and trolley at the time of testing:

Class of active Surface disinfectant Manufacturer Listing


ingredient
Chlorine-releasing BruTab 6S Brulin EPA1)
agents Clorox Professional Disinfecting Clorox EPA
Bleach Cleaner
Dispatch Hospital Cleaner Disin-
fectant Towels with Bleach
Klorsept 17 Medentech EPA
Actichlor plus Ecolab USA EPA

Instructions for use PulmoVista 500 SW 1.3n 123


Reprocessing

Class of active Surface disinfectant Manufacturer Listing


ingredient
Oxygen-releasing Descogen Liquid Antiseptica CE
agents Descogen Liquid r.f.u.
Oxygenon Liquid r.f.u.
Dismozon plus BODE Chemie CE
Oxycide Ecolab USA EPA
Perform Schülke & Mayr CE
SteriMax Wipes Aseptix CE
Incidin OxyWipes Ecolab USA CE
Quaternary ammonium acryl-des2) Schülke & Mayr CE
compounds Mikrozid alcohol free liquid2)
Mikrozid alcohol free wipes2)
Mikrozid sensitive liquid2)
Mikrozid sensitive wipes2)
Cleanisept Wipes Maxi Dr. Schumacher CE
Surfa'Safe Premium ANIOS Laboratories CE
Wip'Anios Excel
Tuffie 5 Vernacare ARTG3)
1) United States Environmental Protection Agency
2) Virucidal against enveloped viruses
3) Australian Register of Therapeutic Goods

Dräger states that oxygen-releasing agents and


chlorine-releasing agents may cause color change
in some materials. Color change does not indicate
that the product is not functioning correctly.
Other surface disinfectants are used at one's own
risk.

124 Instructions for use PulmoVista 500 SW 1.3n


Reprocessing

After reprocessing

Assembling and fitting device-specific components

Prerequisites:
– All components have been reprocessed and
dried.
Procedure:
 See chapter "Getting started" on page 49.

Preparation before next use of device

Checking the operational readiness


Prerequisites:
– The device is assembled and prepared ready
for operation.
Procedure:
 Check the operational readiness, see chapters
"Assembly and preparation" on page 41 and
"Getting started" on page 49

Instructions for use PulmoVista 500 SW 1.3n 125


This page has been left blank intentionally.

126 Instructions for use PulmoVista 500 SW 1.3n


Maintenance

Maintenance

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Definition of service terminology. . . . . . . . . . . . 129

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Preventive maintenance . . . . . . . . . . . . . . . . 130

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Instructions for use PulmoVista 500 SW 1.3n 127


Maintenance

Overview

This chapter describes the maintenance measures WARNING


required to maintain the proper functioning of the
Limited availability
medical device. Maintenance measures must be
performed by the personnel responsible. The battery of the power supply module must
be replaced at periodic intervals.
WARNING
Risk of infection NOTE
Users, service personnel and specialized ser- If PulmoVista 500 is to be isolated from the mains
vice personnel can become infected with power supply, e.g., for maintenance, it is neces-
pathogenic germs. sary to pull out the mains plug from the mains
socket outlet.
Disinfect and clean device or device parts be-
fore any maintenance measures and also be-
NOTE
fore returning the medical device for repair.
Prior to any maintenance and repair work the pa-
tient must be fully disconnected from the device.
WARNING
Risk of electric shock It is not advisable to use the electrode belt or the
Current-carrying components are located un- patient cable for longer than 1 year, or the trunk
der the housing covers. cable for longer than 2 years as components may
– Do not remove the housing covers. deteriorate over time and with usage.
– Maintenance measures must be performed
by the personnel responsible. Dräger rec-
ommends DrägerService to perform these
tasks.

WARNING
Risk of fire, explosion, or excessive tempera-
ture
Replacement of the batteries must only be
performed by specialized service personnel.

WARNING
If the device is mechanically damaged or if it
is not working correctly, do not use it. Contact
service personnel.

WARNING
When servicing the device, always use re-
placement parts that are qualified to Dräger
standards. Dräger cannot warrant or endorse
the safe performance of third-party replace-
ment parts for use with the device.

128 Instructions for use PulmoVista 500 SW 1.3n


Maintenance

Definition of service terminology

Concept Definition
Service All measures (inspection, preventive maintenance, repair) intended to main-
tain and restore the functional condition of a medical device
Inspection Measures intended to determine and assess the actual state of a medical de-
vice
Maintenance Recurrent specified measures intended to maintain the functional condition
of a medical device
Repair Measures intended to restore the functional condition of a medical device af-
ter a device malfunction

Inspection

Perform inspections at regular intervals and


observe the following specifications.

Measure Interval User group


Inspection Every 2 years Specialized service personnel
Check the electrical safety in accor- Every 2 years Specialized service personnel
dance with IEC 62353
Check that the multiplexer test is oper- Every 2 years Specialized service personnel
ating correctly
Check that the trolley and castors are Every 2 years Specialized service personnel
in sound condition and are operating
correctly
Check that the device, its components, Every 2 years Specialized service personnel
and accessories are in sound condition
(no visible damage, labels complete
and legible, instructions for use at
hand)
Check that the mains power LEDs at Every 2 years Specialized service personnel
the Cockpit and at the power supply
module are operating correctly
Check that the touchscreen is operat- Every 2 years Specialized service personnel
ing correctly

Instructions for use PulmoVista 500 SW 1.3n 129


Maintenance

Preventive maintenance

WARNING WARNING
Risk of faulty components Risk of electric shock
Device failure is possible due to wear or mate- Before performing preventive maintenance,
rial fatigue of the components. disconnect the device from the power supply.
To maintain the proper operation of all compo-
nents, this device must undergo inspection
and preventive maintenance at specified inter-
vals.

The following table shows the preventive maintenance intervals:

Component Interval Measure User group


Internal battery Every 2 years Replace Specialized service personnel
(Infinity P2500)

Repair

Dräger recommends that all repairs are performed


by DrägerService and that only authentic Dräger
repair parts are used.

130 Instructions for use PulmoVista 500 SW 1.3n


Disposal

Disposal

Disposal of the medical device . . . . . . . . . . . 132

Disposal of batteries . . . . . . . . . . . . . . . . . . . 132

Instructions for use PulmoVista 500 SW 1.3n 131


Disposal

Disposal of the medical device

At the end of its service life: of at municipal collection points for waste electrical
and electronic equipment. Dräger has authorized a
 Have the medical device appropriately
company to collect and dispose of this device. To
disposed of in accordance with applicable laws
initiate collection or for further information, visit
and regulations.
Dräger on the Internet at www.draeger.com. Use
the Search function with the keyword "WEEE" to
For countries subject to the find the relevant information. If access to Dräger's
EU Directive 2002/96/EC website is not possible, contact the local Dräger
Organization.
This device is subject to EU Directive 2002/96/EC
(WEEE). In order to comply with its registration
according to this directive, it must not be disposed

Disposal of batteries

The medical device battery contains pollutant


substances.
The following applies to the Federal Republic of
Germany: In accordance with legislation for
batteries, the end user must return batteries
containing harmful substances to the distributor or
the collection center operated by public waste
disposal corporations. The battery contained in the
device must therefore be removed by specialized
service personnel before disposal of the device.
Observe the applicable laws and regulations for
battery disposal.

132 Instructions for use PulmoVista 500 SW 1.3n


Technical data

Technical data

Ambient conditions . . . . . . . . . . . . . . . . . . . . 134

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Performance characteristics . . . . . . . . . . . . . 134

Operating data . . . . . . . . . . . . . . . . . . . . . . . . 135

Classification . . . . . . . . . . . . . . . . . . . . . . . . . 136

Communication interfaces on Medical


Cockpit Infinity C500 . . . . . . . . . . . . . . . . . . . 137

Device combinations . . . . . . . . . . . . . . . . . . . 137

EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 137


General information . . . . . . . . . . . . . . . . . . . . . 137
Electromagnetic environment . . . . . . . . . . . . . . 138
Recommended separation distances from
wireless communication devices . . . . . . . . . . . 139

Connections to IT networks . . . . . . . . . . . . . 139

Instructions for use PulmoVista 500 SW 1.3n 133


Technical data

Ambient conditions

During operation
Temperature (device) 5 to 40 °C (41 to 104 °F)
Temperature (electrode belt and cables) 5 to 45 °C (41 to 113 °F)
Ambient pressure 700 to 1060 hPa (10.15 to 15.37 psi)
Relative humidity 20 to 95 %, without condensation
Height Up to 3000 m (9842 ft)
During storage and transportation
Temperature –20 to 40 °C (–4 to 104 °F)
Ambient pressure 500 to 1060 hPa (7.25 to 15.37 psi)
Relative humidity 20 to 90 %, without condensation

Settings

Frame rate 10, 15, 20 or 30 frames per second


Frame rate with the option ADAP 10, 15, 20, 30, 40 or 50 frames per second
Cut-off frequency for low pass filter 10 to 300/min
Upper and lower cut-off frequencies for the band- 30 to 300/min
pass filter

Performance characteristics

EIT measurement
Number of electrodes 16 electrodes plus 1 reference electrode
Feed current amplitude Max. 9 mA (rms, depending on the frequency of the
feed current)
80 to 100 % of maximum patient auxiliary current
conforming to IEC 60601-1 (3rd edition)
Frequency of the feed current and the mea- 80 to 130 kHz
surement
Pulse length of the feed current per electrode pair 2.5 to 12.5 ms (depending on the frame rate)
Display unit (Medical Cockpit Infinity C500)
Resolution 1440 x 900 pixels
Contrast ratio Min. 500 : 1
Horizontal viewing angle 130° (typical)
Vertical viewing angle 100° (typical)

134 Instructions for use PulmoVista 500 SW 1.3n


Technical data

Operating data

Mains power supply


Mains supply nominal voltage and frequency 100 V to 240 V, 50/60 Hz
range
Mains power supply characteristics Mains supply must comply with clause 4.10.2 of
IEC 60601-1 (3rd edition) and, in particular, comply
with overvoltage category II or lower in accordance
with IEC 60664-1.
Inrush current 1.1 A (typical)
Current consumption
at 230 V Max. 0.6 A
at 100 V Max. 1.3 A
Power consumption
maximum during operation 125 W
typically during operation Approx. 80 W
maximum when device is switched off, but 40 W
charging batteries
Internal battery
Type VRLA lead batteries, maintenance-free (2 pcs)
(VRLA: Valve Regulated Lead Acid)
Rated voltage 12 V
Rated capacity 5.5 Ah, 10 hours discharge
(550 mA up to 10.5 V DC)
Fuse F15AL 32 VDC, interrupting capacity 1000 A,
UL 248-1, plug-in fuse 19.05 mm x 18.54 mm x
5.08 mm (0.75 in x 0.73 in x 0.2 in)
Time bridged following mains power failure
With new and fully charged internal battery Min. 5 minutes (typically 10 minutes)
Charging
Charging time (fully discharged batteries) Min. 12 hours
Sound pressure level (for free-field measurement Max. 45 dB(A)
over a reflecting surface)
Dimensions (W x H x D)
PulmoVista 500 incl. trolley 600 mm x 1400 mm x 750 mm
(23.62 in x 55.12 in x 29.53 in)
Weight
PulmoVista 500 including trolley at maximum 44 kg (97 lbs)

Instructions for use PulmoVista 500 SW 1.3n 135


Technical data

Operating data (Continued)

Materials used
Electrode belt Silicone rubber, conductive silicone rubber, stain-
less steel, gold-plated brass
Patient cable Plastics (thermoplastic polyurethane (TPU), poly-
amide (PA), polyurethane (PUR), polypropylene
(PP), thermoplastic elastomer (TPE), polybutylene
terephthalate (PBT))
Trunk cable Plastics (polyamide (PA), thermoplastic polyure-
thane (TPU), polyurethane (PUR))

Classification

Applied parts Applied parts are: electrode belt, reference elec-


trode, patient cable, trunk cable
Mode of operation Continuous
Protection against electric shock regarding
External power supply Protection class I according to IEC 60601-1
Applied parts Type BF conforming to IEC 60601-1
Protection against harmful ingress of water IPX1 (dripping water: Vertically falling drops) con-
forming to IEC 60529
Microenvironments of pollution Level 2 conforming to IEC 60601-1
Electromagnetic compatibility (EMC) (conforming Class A, tested in accordance with IEC 60601-1-2
to European Directive 89/336/EEC)
Biocompatibility of the applied parts Tested in accordance with ISO 10993 for intact skin
and an application duration of <24 hours
Classification Medical Device Europe Class IIa

136 Instructions for use PulmoVista 500 SW 1.3n


Technical data

Communication interfaces on Medical Cockpit Infinity C500

Digital outputs Communication interfaces


USB interfaces at the Cockpit sides Passive USB storage media only
Digital inputs
RS 232 connector 1 (9-pin) (on the rear panel) MEDIBUS connection for Dräger device
RS 232 connector 3 (9-pin) (on the rear panel) Reserved for future use
The RS 232 ports are electrically isolated from
the equipment electronics.

Device combinations

This device can be operated in combination with operating organization must ensure that the device
other Dräger devices or with devices from third- combination complies with the applicable editions
party manufacturers. Follow the accompanying of the relevant standards for medical devices.
documents of the individual devices.
Device combinations approved by Dräger meet the
If a device combination is not approved by Dräger, requirements of the following standards:
the safety and the functional integrity of the – IEC 60601-1 (electrical safety, mechanical
individual devices may be compromised. The safety, software)
– IEC 60601-1-2 (EMC)

EMC declaration

General information

This device was tested for electromagnetic functions correctly in the desired arrangement
compatibility using accessories from the list of before use. The instructions for use for the other
accessories. Other accessories may only be used devices must be followed.
if they do not compromise the electromagnetic
compatibility. The use of non-compliant NOTE
accessories may result in increased In the case of transient high voltage in the mains
electromagnetic emissions or decreased power supply, it may not be possible to switch off
electromagnetic immunity of the device. the device. Contact DrägerService.
This device may be used in the direct vicinity of
other devices only if Dräger has approved this
device arrangement. If no approval has been given
by Dräger, it must be ensured that this device

Instructions for use PulmoVista 500 SW 1.3n 137


Technical data

Electromagnetic environment

This device may only be used in environments


specified in section "Environments of use"
on page 18.

Emissions Compliance
Radiated emissions Class A, group 2 (30 MHz to 1 GHz)
Conducted emissions Class A, group 2 (150 kHz to 30 MHz)

NOTE
The emissions characteristics of this equipment
make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a res-
idential environment (for which CISPR 11 class B
is normally required), this equipment might not of-
fer adequate protection to radio-frequency com-
munication services. The user might need to take
mitigation measures, such as relocating or re-ori-
enting the equipment.

Immunity against Test level and required electromagnetic environ-


ment
Electrostatic discharge (ESD) (IEC 61000-4-2) Contact discharge: ±8 kV
Air discharge: ±15 kV
Fast transient electrical disturbances (bursts) Power cable: ±2 kV
(IEC 61000-4-4) Longer signal input lines/output lines: ±1 kV
Impulse voltages (surges) (IEC 61000-4-5) Voltage, external conductor – external conductor:
±1 kV
Voltage, external conductor – protective ground con-
ductor: ±2 kV
Magnetic fields at mains frequency 50 Hz: 30 A/m
(IEC 61000-4-8)
Voltage dips and short interruptions in the supply Voltage dips of 30 % to 100 %, 8.3 ms to 5 s, differ-
voltage (IEC 61000-4-11) ent phase angles
Radiated high-frequency disturbances 80 MHz to 2.7 GHz: 3 V/m
(IEC 61000-4-3)
Conducted high-frequency disturbances 150 kHz to 80 MHz: 3 V, ISM bands: 6 V
(IEC 61000-4-6)
Electromagnetic fields in the vicinity of wireless Various frequencies from 385 MHz to 5785 MHz:
communication devices 9 V/m to 28 V/m

138 Instructions for use PulmoVista 500 SW 1.3n


Technical data

Recommended separation distances from wireless communication devices

To ensure that the functional integrity of this device


is maintained, there must be a separation distance
of at least 1.0 m (3.3 ft) between this device and
wireless communication devices.

Connections to IT networks

WARNING – Performing upgrades or updates on devices


that are connected to the network
Risk of device malfunction and data protec-
tion violation The following IT networks can be established using
the RS232 interface and the USB port of
Only establish data connections directly to the
PulmoVista 500:
Dräger devices specified in these instructions
for use. – RS232 interface according to EIA RS-232
(CCITT V.24/V.28) for MEDIBUS and
Do not use serial port extenders, hubs or sim-
MEDIBUS.X in a point-to-point connection
ilar for the MEDIBUS connection.
(exclusively for the Dräger devices specified in
Do not connect the device to a hospital IT net- these instructions for use with a data
work. connection validated by Dräger)
– Interfaces based on USB 1.1 or USB 2.0 to
In an IT network, data can be exchanged by means
connect a passive USB storage medium without
of wired or wireless technologies. An IT network
its own voltage supply or to connect a USB card
can be any data interface (e.g., RS232, LAN, USB,
reader supplied by Dräger
printer interface) that is described in standards and
conventions. PulmoVista 500 can receive data from the specified
Dräger devices via the MEDIBUS or MEDIBUS.X
Connecting this device to a network that
interface and supports the following functions:
incorporates other devices or making subsequent
– Display of waveforms and parameter data
changes to that network can lead to new risks for
– Recording and saving of data
patients, users, and third parties. Before the device
is connected to the network or the network is PulmoVista 500 can save EIT files with the
changed, these risks must be identified, analyzed following data on a USB storage medium via the
and evaluated by the hospital IT representative in USB interface:
accordance with the IEC 80001-1 standard (risk – EIT data
management for medical IT networks). Appropriate – Patient data
measures must be taken on the basis of the results. – Data from a Dräger device received via
MEDIBUS or MEDIBUS.X
Examples of subsequent changes to the network:
Software options can be enabled via the USB port.
– Changing the network configuration
Only use SIM cards and USB-SIM card readers
– Removing devices from the network supplied by Dräger.
– Adding new devices to the network

Instructions for use PulmoVista 500 SW 1.3n 139


Technical data

Only service personnel are allowed to connect


PulmoVista 500 via the MEDIBUS or MEDIBUS.X
interface to the specified Dräger devices. The
accompanying documents of the Dräger device to
be connected must be observed.
Subsequent changes to the passive USB storage
medium, e.g., formating using different operating
systems or loading different data using an IT device
may impair the correct operation of the data
transmission from or to the USB storage medium.
The USB port of PulmoVista 500 does not include
an integrated virus scanner and has no firewall
installed. This does not pose a risk to the correct
medical operation of the device, but transmitted
data can be distorted, damaged or deleted.
Removal of the USB storage medium or the data
cable to the Dräger device during data transmission
may damage the transmitted data.
Any other use of PulmoVista 500 interfaces is
prohibited and may lead to new risks for patients,
users and third parties.

140 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Principles of operation

Image generation . . . . . . . . . . . . . . . . . . . . . . 142


Determination of regional bioelectric
properties within the thorax . . . . . . . . . . . . . . . 142
Image reconstruction . . . . . . . . . . . . . . . . . . . . 143
Bioelectric properties of lung tissue . . . . . . . . . 144
Functional EIT . . . . . . . . . . . . . . . . . . . . . . . . . 145
Some examples of EIT images from
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 145
Special considerations when using the
Diagnostic view. . . . . . . . . . . . . . . . . . . . . . . . . 149
Electrode plane. . . . . . . . . . . . . . . . . . . . . . . . . 151

Information displayed by
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 152
Dynamic image. . . . . . . . . . . . . . . . . . . . . . . . . 152
Status images. . . . . . . . . . . . . . . . . . . . . . . . . . 152
Impedance waveforms . . . . . . . . . . . . . . . . . . . 153
Numeric values. . . . . . . . . . . . . . . . . . . . . . . . . 153

Definition of baseline frames . . . . . . . . . . . . 159


Main and Full-screen image and Ptp
analysis view views . . . . . . . . . . . . . . . . . . . . . 159
End-insp. trend and Diagnostics views. . . . . . . 160
EELI trend view . . . . . . . . . . . . . . . . . . . . . . . 161
Data review page (optional with the option
ADAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Definitions for color scales and scales of


impedance waveforms . . . . . . . . . . . . . . . . . . 162
Main and Full-screen image and Ptp
analysis view views . . . . . . . . . . . . . . . . . . . . . 162
End-insp. trend, EELI trend and
Diagnostics views . . . . . . . . . . . . . . . . . . . . . . . 163
Data review page (optional with the option
ADAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Principles of breath detection and


determination of the tidal rate . . . . . . . . . . . . 164

Pressure measurements with the


PressurePod and derived parameters . . . . . 165

Literature references . . . . . . . . . . . . . . . . . . . 167

Instructions for use PulmoVista 500 SW 1.3n 141


Principles of operation

Image generation

Determination of regional bioelectric


properties within the thorax

PulmoVista 500 is a functional lung monitor that


performs thoracic bioimpedance measurements by
applying the technique of electrical impedance
tomography (EIT). PulmoVista 500 determines the
regional bioelectric properties within a cross-
sectional plane (the "electrode plane") of the
thorax.
To perform the measurements, an electrode belt
containing 16 electrodes is placed around the chest
wall. Additionally, one reference electrode is
attached to a central part of the body, preferably on
the abdomen. The reference electrode ensures that

034
all bioimpedance measurements at different Subsequently, the adjacent electrode pair is used
electrode pairs are referenced to the same electric for the next current injection and another 13 voltage
potential. measurements are performed. The location of the
injecting and measuring electrode pairs
Principle of measurement successively rotates around the entire thorax. One
complete rotation results in 16 voltage profiles,
PulmoVista 500 applies a known alternating current each consisting of 13 voltage measurements. The
"I1" to a pair of electrodes and measures the resulting 208 values, called a frame, are used to
resulting surface potentials "Vn" at the remaining reconstruct one cross-sectional image.
13 electrode pairs. Applying the law of Ohm, the
bioelectric impedance between the injecting and
the measuring electrode pairs can be determined
from the known current and the measured voltages.

142 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Image reconstruction Voltage profiles of an inhomogeneous medium


A regional increase of impedance (E) of the subject
A current injection (A) at the surface of a subject results in a change in each of the 16 voltage
with homogenous bioelectric properties causes a profiles which make up one frame.
reproducible distribution of potentials inside the
subject. The regions in the thorax with the same No matter where the current is injected, the
electrical potential, as a result of current injection, regional increase of impedance always causes an
are called isopotential lines (B). The distribution of increase of the voltages "behind" this region.
isopotential lines contributes to a predictable
voltage profile on the surface of the body. The
voltages (C) next to the current injection are the
highest, as indicated by the darker gray color. The
voltages decrease with increasing distance from
the current injection. The voltage (D) on the side E
opposite the current injection is the lowest.

A
C

036
PulmoVista 500 uses a FEM-based, linearized
Newton-Raphson reconstruction algorithm to
D convert the 208 voltage changes of a frame into an
035

EIT image. For better illustration, a schematic


approach for image reconstruction is described
below, which generates the images in a
comparable way.

Instructions for use PulmoVista 500 SW 1.3n 143


Principles of operation

Superposition of voltage profiles Like CT scans, the projection of the displayed EIT
images is from caudal to cranial. That means that
The reconstruction algorithm superposes the
the left side of the image displays the right side of
16 voltage profiles on each other. Reconstruction
the patient. The upper part of the image displays
artifacts are eliminated by applying selective
the ventral aspect of the patient.
boundary filtering.

Bioelectric properties of lung tissue

The measured voltages depend on the


bioimpedance of the body tissue between the
injecting and the measuring electrode pairs. The
impedance of lung tissue changes with the air
content. Thus ventilation and changes of end-
expiratory lung volume result in changes of the
voltages measured at the body surface.
Resistivity of different tissues [1]*:

Tissue Resistivity
(, m)
Blood 1.5
Heart 1.6 to 4.3
037

Lung (end of expiration) 7.2


Lung (end of inspiration) 23.6
Resulting image Fat 27.2
The resulting image (F) displays the region of
In humans, an inspiration maneuver from residual
increased impedance (E) at the correct location.
volume to total lung capacity amplifies regional
bioimpedance by around 300 % [2, 3]*.
F Cardiac activity and perfusion cause a change in
thoracic bioimpedance from diastole to systole in a
range of 3 % [4]*.
Extravascular lung water, body movement, and the
skin-electrode resistance can also affect thoracic
bioimpedance in different ways.

E
038

Each EIT image consists of a matrix of


32 x 32 pixels. In order to create larger images
for better graphical representation, and particularly
for better interpretability, linear interpolation is
applied. However, the underlying resolution of the
images remains unchanged.
* "Literature references" on page 167

144 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Functional EIT and ROI 3 in this example) accounts for 52 to 55 %


of global ventilation (defined as 100 %) in a seated
PulmoVista 500 performs functional EIT, meaning or supine individual.
that it mainly displays relative impedance changes
as a result of lung function, i.e., ventilation and Status image of lungs of an obese, otherwise
changing end-expiratory lung volume. healthy, adult
If the signals are not filtered, cardiac-related
impedance changes are also displayed. All other
factors which might affect the absolute impedance
are eliminated by only displaying relative
impedance changes, rather than absolute
impedance values.
Thus the dynamic images provided by PulmoVista
500 contain information on the functional condition
of the different lung regions within the electrode
plane.
Various validation studies [5, 6, 7, 8, 9, 10, 11, 12]*
have demonstrated a significant correlation

548
between ventilation-related impedance changes In healthy lungs there is little difference in the
and air content, for example as determined by distribution of ventilation between normal-weight
CT scans. and obese individuals. However, the ventilated lung
regions of obese individuals are displayed much
smaller in the image as the lungs are surrounded by
Some examples of EIT images from a large amount of adipose tissue.
PulmoVista 500
Pathological conditions which may lead to non-
Status image of lungs of a normal-weight ventilated lung regions
healthy adult
Various factors are associated with non- or under-
ventilated lung regions. These may include:
– overinflation (more common in the ventral
regions)
– pneumothorax (more common in the ventral
and lateral lung regions)
– atelectasis (more common in the dorsal
regions)
– pleural effusion (more common in the dorsal
regions)
– pneumonia
547

Subjects of normal body weight show ventilation


which is fairly evenly distributed, as shown in the
above image. Corresponding to findings in the
literature [1]*, the right lung (represented by ROI 1

Instructions for use PulmoVista 500 SW 1.3n 145


Principles of operation

EIT and CT images from a patient with dorsal Interpretation of negative impedance changes
pleural effusion
The definition of baseline frames typically leads to
a display of solely positive impedance changes.
Nevertheless, in some circumstances negative
impedance changes may occur which need to be
interpreted correctly.
The following known effects may lead to negative
impedance changes:
– A deeper expiration than inspiration. Since the
baseline is taken at a particular end-expiratory
level, a deeper expiration in the subsequent
breath reduces the end-expiratory lung volume
and thus leads to values below the defined
549

baseline level.
A fluid accumulation such as a pleural effusion
represents a non-ventilated area and is displayed – Pendelluft: The baseline frame taken at the end
by PulmoVista 500 in black or purple color. In the of expiration defines, for every pixel, the zero
CT scan the same region is displayed in bright level. If all parts of the lung increase and
color. decrease their impedance simultaneously, then
negative values do not occur. However, when a
lung region has different filling characteristics to
other lung regions, the minimum of this
particular region may differ from the defined
zero level. This may then result in negative
values in this region.
– Artifacts: During EIT measurements, various
conditions may cause artifacts, which need to
be considered during interpretation of images.
550

146 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

General considerations – The relationship between volume changes and


impedance changes may be affected by the
PulmoVista 500 is not a life-supporting device in the
level of end-expiratory lung volume. For
sense of IEC 60601-1-2.
example, the same tidal volume of two
The EIT measurements performed by PulmoVista spontaneous breaths or mechanical breaths
500 and the derived parameters are not defined as applied at very different PEEP levels may result
a measuring function according to the in different impedance changes. Typically, the
Directive 93/42/EEC concerning medical devices. higher the PEEP levels, the lower are the
related impedance changes. For interpretation
When interpreting EIT data, the following
of tidal impedance changes make sure to also
considerations must be taken into account:
consider the volume information provided by
– PulmoVista 500 provides a mean spatial the ventilator.
resolution of approximately 20 % of the thoracic
– Body movements can cause artifacts.
diameter. The spatial resolution decreases
towards the center of the body. – Strong electromagnetic fields of sensitive
frequency bands may create artifacts when the
– The displayed shape of the electrode plane
measurement circuit of the EIT system is
does not exactly match the geometry of the
exposed to these fields. Possible pathways of
patient.
this energy are, for example, the patient, the
– The displayed position of impedance changes mains power supply, the trunk cable, and the
does not always exactly match where the patient cable.
impedance change occurred.
– Low pass filtering and band pass filtering may
– The impedance changes determined by cause a phase shift and thus a delayed display
PulmoVista 500 reflect an interaction of of impedance waveforms.
different physiological processes rather than
– The use of pulsating air suspension mattresses
the effects of one isolated source.
induces a slow, steady modulation of the
– Changes in the PEEP, the blood volume and its impedance waveforms, which may compromise
conductivity, the extra-vascular lung water, the the interpretation of EIT data. This slow
body position, the position of the electrode belt, modulation has especially to be taken into
and the skin-electrode resistance (e.g., after account when interpreting the EELI trend
applying electrode gel) can affect the thoracic view provided by PulmoVista 500.
impedance and in particular the end-expiratory
In the presence of certain physiological conditions,
lung impedance in different ways. These
the reconstruction algorithm may introduce
changes have especially to be taken into
overshoot effects leading to areas of large negative
account when interpreting the trend data
impedance changes. These areas are displayed in
provided by PulmoVista 500.
purple. This effect may occur when regions of high
conductivity (e.g., the heart, pleural effusion) and
low conductivity (e.g., well-ventilated lung tissue)
are located next to each other.

Instructions for use PulmoVista 500 SW 1.3n 147


Principles of operation

Examples
Example of an artifact induced by electromagnetic
fields:

551

Status images with artifacts often contain


alternating patterns of positive and negative
impedance changes.
Example of an overshoot:

Tidal image
dZ

Global
ROI 2

A
ROI 1
ROI 1

B
ROI 2

C
539

The overshoot phenomenon may cause inverted


regional impedance changes relative to the global
impedance waveform. This results in negative
values of the corresponding parameters for the
regional tidal or minute tidal variations.
The minimum value in the Global impedance
waveform is always defined as end of expiration (A)
which usually concurs with the minimum value in
the regional impedance waveforms. In this
example, the minimum in the Global impedance
waveform concurs with ROI 1 (B), but in ROI 2 the
overshoot leads to a maximum value (C).

148 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Special considerations when using the The following aspects must be carefully considered
Diagnostic view when ascertaining the compliance changes
C loss LP [%] and C loss HP [%] as well as
As with any recent clinical information, experience C loss [%] and C win [%]:
with the numeric values described in this case is – Before the start of the PEEP trial function,
also limited. For this reason, users should interpret make sure that every PEEP level has been
these numeric values carefully and under correctly assigned to a section. A section
consideration of other, well-established clinical averages the selected number of spontaneous
data. breaths. For this reason, sections which contain
several breaths must be set to areas with an
The Recruitability function enables the evaluation end-expiratory lung impedance which is as
of trend data which includes recruitment constant as possible.
maneuvers. Conclusions about the potential – The change to the regional ventilation can only
recruitability of the lung can be drawn from changes be interpreted as a change to the regional
in compliance as well as in the end-expiratory lung compliance if the ventilator displays a flow of
volume [16]. Therefore, in addition to changes in 0 at the end of the inspiration and expiration.
regional compliance (C loss [%], C win [%]), This is because, if regional inspiratory times or
changes in end-expiratory lung impedance (EELI) expiratory times are shorter than the
are also shown in this analysis. corresponding regional time constants,
For PEEP maneuvers, the PEEP trial function a C loss LP [%] and C loss HP [%] as well as
enables the systematic analysis of regional C loss [%] and C win [%] may also be triggered
changes to compliance and delays in regional by varying regional time constants.
ventilation RVD in addition to the evaluation of – If the ventilator transfers no EIP value, the PIP
ventilation distribution. A compliance loss towards parameter can be used as a substitute for the
higher PEEP levels (C loss HP [%]) may indicate calculation of the compliance during volume-
overdistended regions, and a compliance loss controlled ventilation. For this, the AutoFlow
towards lower PEEP levels (C loss LP [%]) may function must be activated.
indicate collapsed regions [13]. – If no ventilation pressures are available from the
ventilator, the ventilation change can only be
In contrast, the Customized function enables the interpreted as a change to the compliance
evaluation of any other therapeutic measures. during pressure-controlled ventilation. This is
Here, the compliance win (C win [%]) and because if no ventilation pressures are detected
compliance loss (C loss [%]) compared to the during volume-controlled ventilation, the falling
selected reference section is displayed and pressure differences may cause the regional
indicated as a percentage change. tidal variation to decrease, which, in turn, would
RVD is a parameter which displays regional cause the C loss LP [%], C loss HP [%], and
inspiration delays compared to global inspiration C loss [%] to rise, without any change to the
and may indicate the cyclical collapse and re- regional compliance of the lung. The pressure
opening of lung regions [14, 15]. difference may have fallen due to rising
compliances in other lung areas at the
respective PEEP level.

Instructions for use PulmoVista 500 SW 1.3n 149


Principles of operation

The following aspects must be carefully considered


when defining the RVD parameter (Regional
Ventilation Delay):
– The ventilation may also be delayed in lung
regions with large time constants. This is
particularly apparent with a short expiratory
time or with a quick rise in the ventilation
pressure together with a long inspiratory time.
– The longer the pressure rise time, the lower the
impact of varying regional time constants on the
RVD analysis.
– If the ventilator displays a flow of 0 at the end of
the expiration, this indicates a sufficiently long
expiratory time.
– With the RVD analysis of low-flow maneuvers,
the section length must be set to a value of 1 to
prevent the low-flow maneuver from being
averaged together with regular spontaneous
breaths.
All information provided by PulmoVista 500 refers
to the EIT sensitivity region, i.e. to the lens-shaped
intrathoracic volume which is surrounded by the
electrode belt and whose impedance changes
contribute to the generation of EIT images.
Only when the electrode belt is in a suitable
position, can it be assumed that the information
provided by PulmoVista 500 represents volume
changes in the entire lung.
This fact must be taken into consideration in
particular when interpreting the C loss LP [%] and
C loss HP [%] as well as C loss [%] and C win [%]
parameters during PEEP maneuvers:
If the electrode belt is attached too close to the
basal part of the lungs, a PEEP-induced shift of the
diaphragm may cause the ventilation to be
overestimated, meaning that values for
C loss LP [%] and C loss HP [%] as well as
C loss [%] and C win [%] may not only be caused
by overdistension or collapse.
In contrast, if the belt is attached to close to the
apical part of the lungs, an early overdistension of
the apical lung may suggest that basal areas are
also already overdistended.

150 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Electrode plane

In the context of these instructions for use, the term


"electrode plane" describes the lens-shaped intra-
thoracic volume whose impedance changes
contribute to the generation of EIT images.
The actual thickness and shape of the electrode
plane depends on the dimension, the bioelectric
properties, and the shape of the thorax, and Electrode plane
particularly on the morphological structures within
the thorax. Further, the extent of the homogeneity
of transthoracic bioelectric properties also affects
the dimension of this electrode plane.

132
However, as the contribution of impedance
changes outside the electrode plane is relatively
small, the effect on the image is limited.

Electrode plane
122

The electrodes of the electrode belt used with


PulmoVista 500 have a width of 40 mm (1.6 in).
This means that the electrode plane in regions
close to the body surface is at least 40 mm (1.6 in)
thick The thickness of the plane increases towards
the central region of the body.
The contribution of impedance changes is reduced
the further away they are from the electrode plane.
Distance from the electrode plane moves the
position of impedance changes located close to the
body surface towards the central region along the
depicted projection lines.

Instructions for use PulmoVista 500 SW 1.3n 151


Principles of operation

Information displayed by PulmoVista 500

Dynamic image Current breath

The dynamic image continuously displays relative


impedance changes within the electrode plane as a
series of tomograms. The temporal resolution is
high, enabling the assessment of regional
ventilation even at high respiratory rates. For A
example, when the frame rate is set to 20 images B
per second for a patient with a respiratory rate of
20 breaths per minute, PulmoVista 500 generates
60 images per breath.
Relative impedance changes are determined by C
referencing the current frame (i.e., the
208 measured voltages gn, see "Principle of
measurement" on page 142) to a baseline frame
gnref. This results in a frame of relative voltage

039
deviations dgn.
As the baseline frame is continuously updated after
each detected breath, mainly impedance changes
due to tidal ventilation are displayed. Due to this
baseline definition, end-expiratory impedance
variations are suppressed to a great extent in the
dynamic image.

To generate the dynamic image, the reconstructed


frame from the end of expiration of the last detected Status images
breath is always defined as the baseline frame (A).
This means, regardless of the actual values of the Further analysis of the lung regions is achieved
baseline frame (which also reflects a certain using a status image. The status image can be
distribution of absolute impedance), only regional configured as a tidal image or a minute image.
differences between the reconstructed frames
The tidal image represents regional distribution of
(B,C) of the current breath and the baseline frame
impedance changes of the last detected breath.
(A) are displayed. If the end-expiratory impedance
The tidal image is a differential image of the end of
distribution of the current breath is identical to that
inspiration compared to the beginning of
of the last breath, the resulting end-expiratory
inspiration. The tidal image is automatically
dynamic image is a black image (B).
updated after each breath. The beginning of
inspiration and the end of inspiration are indicated
as vertical blue lines on the impedance waveforms.
The minute image represents regional distribution
of impedance changes over the last minute. The
minute image displays tidal images averaged over

152 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

the last minute. The image is ideal for the To make them comparable, all regional impedance
assessment of regional distribution during waveforms are normalized using the same scaling
ventilation with varying tidal volumes. factor. This is usually smaller than the global
scaling factor.
Regional quantification can be customized in the
status image by adjusting the position and size of
the Regions Of Interest (ROIs).
Numeric values

Numeric values are continuously calculated and


Impedance waveforms
displayed. This allows the quantification and
comparison of impedance changes.
The impedance waveforms represent the
impedance changes within the electrode plane over The Tidal rate parameter, determined from the
time. All impedance waveforms are plotted global impedance waveform, typically represents
simultaneously over the same time base. the number of breaths detected per minute. When
the band-pass filter is activated, numeric values are
The Global impedance waveform represents the
not displayed.
sum dZglobal of relative impedance changes dZp in
all pixels of each dynamic image plotted over time. The parameter TV global (global tidal variation)
It is normalized to the display height by a suitable represents the difference between the minimum
scale factor. value and the maximum value in the Global
impedance waveform for each breath. The
parameter MTV global (global minute tidal
variation) represents the average of the global tidal
variations over the last minute. The TV global and
The Global impedance waveform mainly displays MTV global parameters are always defined as
impedance changes related to ventilation. Thus, 100 %, independently of the tidal volume. They
there is usually a strong correlation between this serve solely as a reference for the display of the
waveform and the volume waveform displayed on regional tidal variations or regional minute tidal
ventilators. variations.
dZglobal Regional tidal variations TV ROI represent the
difference between the corresponding values of the
regional impedance waveforms for each breath.
Regional minute tidal variations MTV ROI
Time represent the average of the regional tidal
variations over the last minute. End of expiration
and end of inspiration are detected on the Global
impedance waveform and indicated by markers.
Regional tidal variations and regional minute tidal
131

variations show the percentage of impedance


In contrast to the Global impedance waveform, the change which takes place in the
four regional impedance waveforms display the corresponding ROI.
sum of impedance changes within the specified
ROIs. The regional impedance waveforms allow Further numeric values are displayed in the EELI
comparison of impedance changes in different lung trend view.
regions.

Instructions for use PulmoVista 500 SW 1.3n 153


Principles of operation

The numeric value EELI global displays the C loss [%] and C win [%] are calculated as follows:
deviation of the global end-expiratory status at the
1 The EIT data is low-pass filtered with a cut-off
cursor positions Ref and C in relation to the global
frequency of 80 min–1. The artifact filter is acti-
tidal variation at Ref.
vated.
The numeric value ∆EELI ROI displays the 2 If a section contains several spontaneous
deviation of the regional end-expiratory status at breaths, these are averaged to ascertain the
the cursor positions Ref and C in relation to the tidal variation TV.
global tidal variation at Ref.
3 The tidal variation TVi is calculated for every
In the Diagnostics view, the C loss [%] pixel within the ventilated area.
(= Compliance Loss), ∆EELI, and RVD (= Regional
Ventilation Delay) parameters can also be 4 The compliance is calculated for every section
calculated and displayed for every defined section. and every pixel:
The algorithms used for the calculations are
partially based on publications which point out the
following:
– The method for determining the C loss HP [%] If no pressure values are available from the
and C loss LP [%] parameters enables an ventilator, the EIP – PEEP pressure difference is
estimation of lung region overdistension and set to 1.
collapse [13]
– The RVD index enables the detection of cyclical 5 Every pixel in the selected reference section is
opening and closing of lung regions [14, 15] defined as RefCompliance.
– The combined presentation of changes in 6 In every section and for every pixel, C loss [%]
compliance and lung volume can be used to is calculated as the compliance loss of the sec-
assess the recruitability of the lung [16] tion in comparison with the reference compli-
ance. C loss [%]i is set to 0 if the difference re-
sults in a positive value.
Compliance loss (C loss [%]) and Compliance
Win (C win [%]) C loss i,S o n = Compliance i,,S
i , S e c t iion o n – RefCompliance i
S e c t iion

Trend data without a PEEP maneuver can be 7 The global parameter C loss [%] is also
analyzed using the Customized function. This calculated for every section by summing up the
analysis determines changes in regional compliance loss percentage of all pixels (NV) of
compliance in comparison with a selectable the ventilated area:
reference section for every displayed section.
These changes are expressed as Compliance loss NV
i= 1
i=1 C loss i,Section
i,S e c t ion
C loss S e c ttion (% ) =
i o n (%) x 100%
100
(C loss [%]) and Compliance Win (C win [%]). NV
i= 1
i=1 RefCompliance i

– The C loss [%] parameter describes a regional 8 In every section and for every pixel, C win [%] is
compliance loss compared to the reference and calculated as the compliance loss of the section
is displayed in orange. in comparison with the reference compliance.
– The C win [%] parameter describes a regional C win [%]i is set to 0 if the difference results in a
compliance win compared to the reference and negative value.
is displayed in cyan.
C win i,Section
i,S e c t ion = Compliance i,Section
,S e c tion – RefCompliance i
Pixels with the same compliance as in the
reference section are displayed in dark gray. 9 The global parameter C win [%] is also
calculated for every section by summing up the
compliance win percentage of all pixels:
NV
i= 1
i=1 C win i,Section
i,S e c t ion
C win Section (% ) =
S e c tion (%) x 100%
100
NV
i= 1
i=1 RefCompliance i

154 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

EELI loss [%] and EELI win [%] An end-expiratory lung impedance loss
(EELI loss [%]) of e.g., 100 % thus corresponds to
Trend data with a recruitment maneuver can be
an end-expiratory lung volume loss equal to the
analyzed using the Recruitability function.
global tidal variation or the tidal volume of the
In addition to changes in regional compliance reference section.
(C loss [%], C win [%]), changes in end-expiratory
lung impedance (EELI) are also shown in this
Compliance loss (C loss LP [%] and
analysis. These changes are determined in
C loss HP [%])
comparison with a selectable reference section for
every displayed section, expressed as Trend data with PEEP maneuvers can be analyzed
EELI loss [%] and EELI win [%]. using the PEEP trial function. In this analysis,
– As in the EELI trend view, ∆EELI images are C loss [%] images only represent the PEEP-
also displayed in this analysis, each relating to induced regional compliance loss for various levels
the end-expiratory lung impedance (EELI) of of a PEEP maneuver.
the reference section.
With this method, both of the following conditions
– Pixels with an EELI loss are shown in orange.
are differentiated for every pixel:
Pixels with an EELI win are shown in cyan.
– The C loss LP [%] parameter describes the
– Pixels without EELI changes are displayed in
regional compliance loss compared to the
dark gray.The
ascertained maximum regional compliance
– The EELI loss [%] parameter is calculated by
towards lower PEEP levels and is displayed in
adding together the regional loss of end-
white.
expiratory lung impedance compared to the
– The C loss HP [%] parameter describes the
reference and is displayed in orange.
regional compliance loss compared to the
– The EELI win [%] parameter is calculated by
ascertained maximum regional compliance
adding together the regional win of end-
towards higher PEEP levels and is displayed in
expiratory lung impedance compared to the
orange.
reference and is displayed in cyan.
Pixels without compliance loss are displayed in
The EELI loss [%] and EELI win [%] parameters
dark gray.
are calculated as follows:
C loss LP [%] and C loss HP [%] are calculated as
1 The EIT data is low-pass filtered with a cut-off
follows:
frequency of 80 min–1. The artifact filter is
activated. 1 The EIT data is low-pass filtered with a cut-off
frequency of 80 min–1. The artifact filter is
2 If a section contains several spontaneous
activated.
breaths, the end-expiratory values are
averaged. 2 If a section contains several spontaneous
breaths, these are averaged to ascertain the
3 The respective amounts of the positive and
tidal variation TV.
negative pixel values of the ∆EELI images
within the ventilated areas are added up and 3 The tidal variation TVi is calculated for every
divided by the global tidal variation of the tidal pixel within the ventilated area.
image of the reference section. In contrast to
4 The compliance is calculated for every section
the EELI trend view, the values in this
and every pixel:
analysis are multiplied by a factor of 100 and
shown as a percentage increase (win) and
decrease (loss).

Instructions for use PulmoVista 500 SW 1.3n 155


Principles of operation

If no pressure values are available from the to the global inspiration (derived from the global
ventilator, the EIP – PEEP pressure difference is impedance waveform) for every pixel within the
set to 1. contour of the ventilated area.
5 The maximum compliance is defined for every The RVD parameter is calculated using the
pixel of all sections. following steps:
6 In every section and for every pixel, 1 The EIT data is low-pass filtered with a cut-off
C loss LP [%]i is calculated as the compliance frequency of 80 min–1. The artifact filter is
loss percentage of the section in comparison activated.
with the maximum compliance. C loss LP [%]i is
2 If a section contains several spontaneous
set to 0 if the observed section is at a higher
breaths, these are averaged to ascertain the
PEEP level than the section with the maximum
RVD parameter.
compliance.
3 A second, adjustable low-pass filter, which only
HighestCompliance i – Compliance i,S
(HighestCompliance on)
C loss LP i,i,SS e cti (% ) =
on (%)
c tion
i , S e c ti
tion
x 100%
100 has an effect on the impedance values used for
HighestCompliance i
the RVD parameter, is also activated.
7 The global parameter C loss LP [%] is also
4 Only pixels within the ventilated area are
calculated as the weighted average of all pixels
analyzed.
of the ventilated area:
5 The Ti start and Ti end moments are defined
NV
i=1
i= (C
C loss LP i,S o n x HighestCompliance i )
i ,See cctt iion for every section based on the global
C loss LP SSee c t iion
on =
NV
i =1
i= 1 HighestCompliance i impedance waveform by ascertaining the start
8 In every section and for every pixel, C loss HP and end of the inflation during a low-flow
[%]i is calculated as the compliance loss maneuver. If the section does not contain a low-
percentage of the section in comparison with flow maneuver, the start and end of the
the maximum compliance. C loss HP [%]i is set inspiration of the regular spontaneous breaths
to 0 if the observed section is at a lower PEEP are ascertained.
level than the section with the maximum 6 The time Ti is calculated, i.e. the time period
compliance. between Ti start and Ti end.

C loss HP i,i,SS e cti


HighestCompliance i – Compliance i,S
(HighestCompliance i , S e c ti on)
tion
x 100%
100
7 For the global impedance waveform: T40glob,
(% ) =
o n (%)
c t ion
HighestCompliance i the moment at which the global impedance
9 The global parameter C loss HP [%] is also waveform reaches 40 % of its tidal variation, is
calculated as the weighted average of all pixels ascertained.
of the ventilated area: 8 For every pixel within the ventilated area: T40i,
the moment at which the regional impedance
NV
(C
C loss HP i,S i o n x HighestCompliance i )
C loss HP SSee c ttion
ion =
i =1
i= 1 i ,See c ttion
NV
waveform reaches 40 % of its tidal variation, is
HighestCompliance i
i =1
i= 1
ascertained.
9 Calculation of the RVD parameter:
Regional ventilation delay (RVD)
During a low-flow maneuver, the algorithm for
quantifying the RVD defines regional inspiratory
delays which can be linked to cyclical opening and The numeric RVD value represents the inspriatory
closing [14, 15]. delay of the observed pixel. The value is based on
the global inspiratory time Ti and therefore
The RVD parameter defines the extent of the represented as a percentage.
temporal delay of the regional inspiration (derived
from the regional impedance waveform) compared

156 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

If the value of the RVD parameter exceeds the RVD Improvement of the algorithms used to
cut-off value set by the user, the affected pixels are calculate C loss LP [%], C loss HP [%], and RVD
marked in yellow in the corresponding tidal image.
Several limitations were identified in the algorithms
described in the referenced publications for the
Global RVD parameters definition of C loss LP [%] [13] and RVD [14, 15].
These limitations were eliminated as follows during
Depending on the configuration, PulmoVista 500
the implementation in PulmoVista 500:
calculates one of two global RVD parameters which
represent either the inhomogeneity of the regional – During PEEP maneuvers, the end-expiratory
inspiration progressions or the ratio of the area lung volume (EELI) is generally high at high
affected by the RVD to the entire ventilated area. PEEP levels and low at low PEEP levels. In
contrast, the tidal variation (TV) remains
– Standard deviation of the RVD (RVD SD) [14,
constant during volume-controlled ventilation.
15]. To calculate the RVD SD parameter,
Because of the calculation of relative
indicated as % of Ti, the standard deviation of
impedance changes in comparison with a
all RVD pixel values is defined within the
baseline, this leads to a loss in the tidal
ventilated area. Therefore, the RVD SD
variations towards higher PEEP levels, which
parameter describes the inhomogeneity of the
are not, however, linked to changes in the tidal
regional inspiration progressions. RVD SD is
volume.
calculated as follows:
Improvement: The tidal variations are adjusted
using a correction factor.
– The C loss LP [%] and C loss HP [%] values
– Ratio of the RVD (RVD Ratio) require knowledge of the pressure values (EIP,
The RVD Ratio (indicated in %), which indicates PEEP) in order to calculate the regional
the ratio of the number of pixels affected by the compliance. This requires the availability of the
RVD (NRVD) to the total number of pixels (NV) pressure values from the ventilator which are,
within the ventilated area, is calculated as the however, often not available.
second RVD parameter. The RVD Ratio
parameter is calculated as follows: Improvement: The C loss LP [%] and C loss HP
[%] values are also calculated, even if no
pressure values are available. This makes it
possible to evaluate all maneuvers which are
performed during constant pressure-controlled
ventilation.
– RVD times are always indicated as positive
values which are ascertained from the earliest
to latest pixel. This makes it difficult to
differentiate regions with quick and slow
inspiration.
Improvement: The global point in time T40glob
is subtracted from the respective T40i point in
time to allow the respective RVD to be indicated
as a positive (= late) and negative (= early)
value.

Instructions for use PulmoVista 500 SW 1.3n 157


Principles of operation

NOTE
The global RVD parameters are not affected by
these changes.

– RVD is only used during low-flow maneuvers.


Up to now, there was no research analyzing
how slowly a ventilation pressure needs to rise
for the RVD to continue returning usable data.
Improvement: The RVD can be calculated for
every spontaneous breath. However, the
inspiratory rise must be considered during RVD
interpretation.
– The respective PEEP values need to be known
to automatically assign sections to the
respective PEEP levels.
Improvement: The various PEEP levels are
indirectly ascertained based on the identified
EELI levels. This enables automatic detection
of the sections, even if no PEEP values are
available.
– The calculation of C loss LP [%], C loss HP [%],
and RVD in regions with very small tidal
variations can be very susceptible to errors.
Improvement: Regions with tidal variations
below 10 % of the maximum tidal variation are
excluded from the calculation.
– Filter settings are not described in every
published analysis, meaning that they could
vary from case to case, especially for
suppressing cardiac impedance changes.
Improvement: Uniform filter settings are used to
calculate C loss LP [%], C loss HP [%], and
RVD. A low-pass filter with a cut-off frequency
of 80 min–1 is used to suppress cardiac
impedance changes. If the definition of the RVD
is still disturbed by cardiac impedance changes
despite the filter, the user can configure an
additional low-pass filter which only affects the
RVD definition.

158 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Definition of baseline frames

Main and Full-screen image and Ptp Baseline update (Breath)


analysis view views Typically, the baseline frame is updated
continuously after each detected end of inspiration.
The Main and Full-screen image and Ptp The update of the baseline frame can be compared
analysis view views focus on providing information to the way a volume waveform of a ventilator
related to functional impedance changes due to returns to zero value at the end of each breath.
ventilation. Consequently, all effects that may impair absolute
All information displayed in Main and Full-screen impedance values and thus lead to end-expiratory
image and Ptp analysis view views (status offsets in the impedance waveform are typically
images, impedance waveforms, and parameters) is eliminated. Only changes which occur within a
based on the dynamic image which continuously respiratory cycle are displayed. Changes are
displays relative impedance changes referenced to mainly caused by ventilation-related impedance
a baseline as a series of cross-sectional images. changes. If not suppressed by filter settings,
impedance changes related to cardiac activity,
Each single image represents the reconstructed which also occur within the respiratory cycle, are
deviations between the current frame and a displayed as well.
baseline frame (BF).
dZglobal
The frame at the end of expiration from the last
BFA BFB BFC
detected breath is defined as the baseline frame.
This baseline frame is the frame with the smallest
value of summarized voltages between the last two 0
0 0 0 0
detected maxima of the Global impedance
waveform.
A B C Time

040
As all frames are referred to the smallest frame of
the last breath, usually only positive changes are A Referred to BFA
displayed in the dynamic image. B Referred to BFB
C Referred to BFC

Instructions for use PulmoVista 500 SW 1.3n 159


Principles of operation

Baseline update (Time scale) End-insp. trend and Diagnostics views


During therapeutic procedures, e.g., recruitment
maneuvers, it might be desirable to observe end- The End-insp. trend and Diagnostics views
expiratory offsets in the impedance waveforms that enable the comparison of the distribution of
are caused by changes of end-expiratory lung ventilation within the electrode plane over a longer
impedance. The baseline update after each period.
detected breath eliminates those offsets. For this The End-insp. trend and Diagnostics views allow
reason, PulmoVista 500 provides the alternative a comparative evaluation of two or more status
baseline update option Time scale, which only images, each representing the regional distribution
affects the display of the impedance waveforms. of ventilation-related impedance changes at two
The dynamic image, status images, and different cursor positions. The End-insp. trend
parameters are not affected by the setting of the view displays the differential image Change: C
baseline update. minus Ref, which represents the changes between
When the baseline update is set to Time scale, the these two status images. Thus the End-insp. trend
baseline is updated each time the cursor passes view enables the comparison of the distribution of
the zero position of the time scale. Consequently, ventilation within the electrode plane of two
the time period between two baseline updates different breaths. The Diagnostics view displays a
depends on the setting of the time scale. tidal image and images of the compliance loss or
compliance change for each selected section.
NOTE For image generation, the breath at cursor position
Occasionally the down-slope of the impedance Ref is referenced to a first baseline frame at the end
waveforms is irregular. This irregularity is due to of expiration before this first breath. The breath at
variations that may occur during the continuous cursor position C is referenced to a second
update of the baseline frames. If the baseline up- baseline frame at the end of expiration before the
date is set to Time scale, irregularities may occur second breath. Similarly, the spontaneous breaths
when the cursor passes the zero position. are referenced to an averaged baseline frame in
every section in the Diagnostics view.
NOTE
By referencing the breaths to individual baseline
Frequent changes of end-expiratory lung imped- frames, all other factors contributing to impedance
ance, which can occur during spontaneous breath- changes and possibly compromising comparison of
ing on the upper pressure level in APRV, for exam- distribution of ventilation are eliminated.
ple, may cause significant baseline changes in the
Main and Full-screen image and Ptp analysis dZglobal
view views. Under those rare conditions, the BFRef BFC
breath-by-breath baseline update leads to large
offsets in the impedance waveforms which may
compromise their interpretability. In such cases, it
is recommended that the baseline update option is
Ref C Time
set to Time scale.
042

160 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

EELI trend view The Change: C minus Ref image of the EELI
trend view displays the changes of end-expiratory
The EELI trend view provides information on lung volume within the electrode plane. In contrast,
changes in end-expiratory lung impedance which the Change: C minus Ref image of the End-insp.
are mainly due to changes of end-expiratory lung trend view displays the changes of tidal volume
volume within the electrode plane. These changes within the electrode plane.
are displayed as positive or negative offsets in the
global and regional impedance waveforms.
Data review page (optional with the
In order to display and quantify those changes, all
frames displayed in this view are referred to one
option ADAP)
single baseline frame at a fixed position. This is in
contrast to the baseline definition of the Main and As in the EELI trend view, all frames displayed in
Full-screen image and Ptp analysis view views. the data review page are referenced to one single
baseline frame at a fixed position.
The frame containing the smallest value of
summarized voltages is defined as the baseline The frame containing the smallest value of
frame, corresponding to the lowest point in the summarized voltages is defined as the baseline
Global impedance waveform. frame. The baseline frame corresponds to the
lowest point in the Global impedance waveform
dZglobal within the entire recorded EIT file.
BFFixed If the time scale is set to smaller values, the
baseline frame might not be present within the
displayed part of the EIT file.

Ref C Time
041

If the view is refreshed or the time scale is changed,


then the baseline frame is redefined.
If the bioelectric conditions of the skin or within the
thorax have significantly changed during the
measurements, these changes may affect the end-
expiratory levels. Thus, comparability of the end-
expiratory levels at Ref and C may be impaired.
The following conditions may affect bioelectric
properties and thus end-expiratory lung
impedance:
– repositioning of the electrode belt
– opening and closing of the electrode belt
– applying electrode gel to the skin of the patient
– change in patient position
– large changes of intra-thoracic fluid content

Instructions for use PulmoVista 500 SW 1.3n 161


Principles of operation

Definitions for color scales and scales of impedance waveforms

Main and Full-screen image and Ptp The zero position of the color scale is always
analysis view views located in a position which provides 85 % for the
display of positive changes (A). The scalar
After image reconstruction, the relative impedance endpoints of positive and negative impedance
changes that have been determined for each of the changes are of the same magnitude. However,
pixels are translated into a color scale. Regions positive impedance changes (A) are represented
with impedance changes of less than 10 % of the over 85 % of the color scale while negative
determined maximum regional impedance change impedance changes (B) are compressed to 15 % of
are represented in black. Impedance changes the color scale.
above 10 % of the maximum regional impedance
change are displayed in dark blue. As values
increase, the dark blue turns into a lighter blue. A
white color indicates the regions of maximum
regional impedance change (i.e., 100 %) within the
image.
The color scale is adjusted continuously ("auto-
scaled") to permanently display the dynamics of
regional ventilation independently of actual tidal
volumes and other bioelectric conditions. Thus all

533
end-inspiratory images typically contain some
white regions. While auto-scaling provides an optimized
continuous display of the distribution of ventilation,
After each detected breath, the minima and
it prevents these images being used for the
maxima of the impedance waveform are
quantitative analysis of ventilation.
determined. The color scale and scales of the
impedance waveforms are adjusted based on the When the reference function has been activated in
determined minimum and maximum values. the Main view, two status images can be displayed.
The scaling of these two images is based on the
Waveforms are auto-scaled so that even small
status image with the smaller maximum impedance
impedance changes are amplified. This means that
change. This scaling may result in white saturated
some conditions (e.g., apnea, very low tidal
areas – either in the reference status image or in
volumes, or damping of waveforms due to filtering)
the current status image and its corresponding
may not be recognized. In order to make the user
dynamic image. Alternatively, the image Change:
aware of this situation, waveforms that only show
Current minus Ref can be selected. The color
very small impedance changes are displayed in a
scale of this differential image is designed to
darker gray color.
display major changes between two images at
The color scales of the dynamic and status images different points in time.
are always the same, thus allowing more effective
As these changes can be positive (C) or negative
comparison. Similarly, the scales of the four
(D), the zero value (representing no change) is
regional impedance waveforms are always set to
always displayed in the midposition of this
the same value.
differential color scale. Negative values are not
As the baseline is "zeroed" after each breath, the compressed.
images usually only contain positive values.

162 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

EELI trend view


Auto-scaling of the differential image in the EELI
trend view is based on the values of the maximum
regional tidal variation as determined at cursor
position Ref. This auto-scaling results in an almost
black image if the compared EELI patterns are very
similar. In contrast, changes of EELI in the range of
the maximum tidal variation at cursor position Ref
result in a differential image with regions which
correspond to the minimum or maximum values of
the color scale.

538
Minimum and maximum values of this color scale
are the same that are taken for the dynamic image. Diagnostics view
Thus, all color scales displayed in the Main and The automatic scaling of the tidal images is based
Full-screen image and Ptp analysis view views on the maximum impedance changes of the
always contain identical end points. selected section. All tidal images and the images of
compliance changes have the same scalar
endpoints. The scaling is based on the tidal image
End-insp. trend, EELI trend and of the section with the smallest maximum
Diagnostics views impedance change. This scaling may result in white
saturated areas in the tidal images of other
The scales for images and impedance waveforms sections.
in the End-insp. trend, EELI trend and
In contrast, the compliance loss images are always
Diagnostics views are automatically scaled each
scaled to 100 %. The color scale of the images of
time these views are either opened, updated, or the
compliance changes is identical to that of the
time scale is changed. If the cursor position is
differential images in the End-insp. trend view.
changed or an analysis is started, the images are
The color scale of the images of the EELI changes
also rescaled automatically.
is identical to that of the ∆EELI images in the EELI
trend view. The color scale of the compliance loss
End-insp. trend view images shows C loss HP [%] in orange and
C loss LP [%] in white. Regions with no compliance
The auto-scaling of the two status images in the
loss are displayed in dark gray.
End-insp. trend view is based on the maximum
impedance changes in these images. The two
status images and the resulting differential image
have the same scalar endpoints. Data review page (optional with the
option ADAP)
The scaling is based on the status image with the
smaller maximum impedance change. This scaling The auto-scaling on the Data review page is based
may result in white saturated areas in the other on the minimum and maximum values contained in
status image. the selected EIT file.

Instructions for use PulmoVista 500 SW 1.3n 163


Principles of operation

Principles of breath detection and determination of the tidal rate

Breath detection is based on the global impedance


waveform. PulmoVista 500 determines the
maximum and minimum values of the last
15 seconds and defines the difference in these
values as the "tidal range". If a positive slope
following a minimum exceeds 25 % of the tidal
range, PulmoVista 500 defines this minimum as the
end of expiration. If a negative slope following a
maximum exceeds 25 % of the tidal range,
PulmoVista 500 defines this maximum as the end
of inspiration.
After the end of expiration has been defined,
PulmoVista 500 only checks for the end of
inspiration, and vice versa. This assures that even
during irregular breathing, the detected end of
inspiration and end of expiration will alternate.
The tidal rate is calculated using the formula
"tidal rate = 180 / t", where t is the time period of
the last 3 detected breaths in seconds.

164 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Pressure measurements with the PressurePod and derived parameters

When the PressurePod is connected and pressure The pressure values and parameters for lung
measurements are activated, the airway pressure, mechanics listed in the table are determined from
esophageal pressure, and gastric pressure can be the pressure waveforms.
imported in PulmoVista 500 and displayed in the
The literature contains detailed descriptions of the
Ptp analysis view.
parameters [17, 18, 19].
The Ptp waveform is determined from the Paw
The following table shows an overview of the
(Pod) waveform and the Pes (Pod) waveform.
pressure values that are displayed in the Ptp
analysis view:

Abbrevia- Explanation Range and unit Accuracy


tion
Paw Airway driving pressure ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
value
Pes Esophageal driving pres- ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
sure value
Ptp Transpulmonary driving ±100 mbar or cmH2O -
pressure
EEPes End-expiratory esophageal ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
pressure value
EEPga End-expiratory gastric pres- ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
sure value
EEPtp End-expiratory transpulmo- ±100 mbar or cmH2O -
nary pressure
EIP End-inspiratory pressure ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
value
EIPes End-inspiratory esopha- ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
geal pressure value
EIPtp End-inspiratory transpulmo- ±100 mbar or cmH2O -
nary pressure
Pdi Transdiaphragmatic pres- ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
sure value
PEEP Positive end-expiratory ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
pressure value
Pga Gastric pressure ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
value
Pga/Paux3 Gastric pressure / auxiliary ±100 mbar or cmH2O ±2 mbar or 3 % of the actual
pressure value

Instructions for use PulmoVista 500 SW 1.3n 165


Principles of operation

The following table shows an overview of the


parameters that are displayed in the Lung
mechanics table. The parameters are only
determined and displayed if imported MEDIBUS
values are available.

Abbrevia- Explanation Unit


tion
Ccw Chest wall compliance mL/mbar or mL/cmH2O
CL Lung compliance mL/mbar or mL/cmH2O
Crs Respiratory system compliance mL/mbar or mL/cmH2O
Ecw Chest wall elastance mbar/L or cmH2O/L
EL Lung elastance mbar/L or cmH2O/L
Ers Respiratory system elastance mbar/L or cmH2O/L
PTPdi Pressure-time product of the transdiaphragmatic pres- mbar * s or cmH2O * s
sure
PTPes Pressure-time product of the esophageal pressure mbar * s or cmH2O * s

166 Instructions for use PulmoVista 500 SW 1.3n


Principles of operation

Literature references

1 Heyward VH. 1998. Practical body composition assessment for children, adults, and older
adults. Int J Sport Nutr (8): 285-307
2 Faes, T. J. C., H. A. van der Meij, J. C. de Munck und R. M. Heethaar. 1999. The electric resis-
tivity of human tissues (100 Hz-10 MHz): A meta-analysis of review studies. Physiol Meas 20 (4):
R1-R10.
3 Barber, D.C. 1989. A review of image reconstruction techniques for electrical impedance tomog-
raphy. Med Phys 16 (2): 162-169.
4 Visser, K. R. 1989. Electric properties of flowing blood and impedance cardiography. Ann
Biomed Eng 17:463-473.
5 Luepschen, H., T. Meier, M. Grossherr, T. Leibecke, H. Gehring and S. Leonhardt. 2005. Clinical
applications of thoracic electrical impedance tomography. Paper presented at the 6th Confer-
ence on Biomedical Applications of Electrical Impedance Tomography, London.
6 Victorino, J. A., J. B. Borges, V. N. Okamoto, G. F. J. Matos, M. R. Tucci, M. P. R. Caramez,
H. Tanaka, et al. 2004. Imbalances in regional lung ventilation: A validation study on electrical
impedance tomography. Am J Respir Crit Care Med 169 (7): 791-800.
7 Hinz, J., P. Neumann, T. Dudykevych, L. G. Andersson, H. Wrigge, H. Burchardi, and G. Heden-
stierna. 2003. Regional ventilation by electrical impedance tomography: A comparison with ven-
tilation scintigraphy in pigs. Chest 124 (1): 314-322.
8 Frerichs, I., J. Hinz, P. Herrmann, G. Weisser, G. Hahn, T. Dudykevych, M. Quintel and G. Hellige.
2002. Detection of local lung air content by electrical impedance tomography compared with
electron beam CT. J Appl Physiol 93 (2): 660-666.
9 Riedel, T., T. Richards and A. Schibler. 2005. The value of electrical impedance tomography in
assessing the effect of body position and positive airway pressures on regional lung ventilation
in spontaneously breathing subjects. Intensive Care Med 31 (11): 1522-1528.
10 Odenstedt, H., S. Lindgren, C. Olegård, K. Erlandsson, S. Lethvall, A. Aneman, O. Stenqvist and
S. Lundin. 2005. Slow moderate pressure recruitment maneuver minimizes negative circulatory
and lung mechanic side effects: Evaluation of recruitment maneuvers using electric impedance
tomography. Intensive Care Med 31 (12): 1706-1714.
11 van Gendringen H. R., A. J. van Vught and J. R. Jansen. 2004. Regional lung volume during
high-frequency oscillatory ventilation by electrical impedance tomography. Crit Care Med 32 (3):
787-794.
12 Meier, T., H. Luepschen, J. Karsten, T. Leibecke, M. Großherr, H. Gehring and S. Leonhardt.
2008. Assessment of regional lung recruitment and derecruitment during a PEEP trial based on
electrical impedance tomography. Intensive Care Med 34 (3): 543-550.
13 Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside
estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomog-
raphy. Intensive Care Med 2009; 35:1132-1137.
14 Muders T, Luepschen H, Zinserling J, Geschus S, Fimmers R, Guenther U, et al. Tidal recruit-
ment assessed by electrical impedance tomography and computed tomography in a porcine
model of lung injury*. Crit Care Med. 2012; 40 (3): 903-11.

Instructions for use PulmoVista 500 SW 1.3n 167


Principles of operation

15 Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther U, von der Groeben C, et al. Electrical
impedance tomography compared with thoracic computed tomography during a slow inflation
maneuver in experimental models of lung injury. Crit Care Med. 2008; 36 (3): 903-9.
16 Godet T, Constantin JM, Jaber S, Futier E. How to monitor a recruitment maneuver at the bed-
side. Curr Opin Crit Care 2015, 21:253-258.
17 Akoumianaki E et al., The Application of Esophageal Pressure Measurement in Patients with Re-
spiratory Failure. Am J Respir Crit Care Med Vol 189, Iss 5, pp 520-531, Mar 1, 2014.
18 Mauri T et al., Esophageal and transpulmonary pressure in the clinical setting: meaning, useful-
ness and perspectives. Intensive Care Med. 2016 Sep; 42 (9): 1360-1373.
19 Nava S et al., Patient-ventilator interaction and inspiratory effort during pressure support venti-
lation in patients with different pathologies. Eur Respir J, 1997; 10:177-183.

168 Instructions for use PulmoVista 500 SW 1.3n


List of accessories

List of accessories

Due to approvals, not all articles are available


worldwide.

Name/Description Order-No.
Trunk cable 8420048
Patient cable for pediatric patients (for electrode 8422770
belt sizes XS-4XS)
Patient cable, size S 8420029
Patient cable, size M 8420047
Patient cable, size L 8420035
Patient cable, size XL 8420271
Patient cable, size XXL 8420273
Electrode belt, size 4XS 8422583
Electrode belt, size 3XS 8422582
Electrode belt, size 2XS 8422581
Electrode belt, size XS 8422580
Electrode belt, size S 8420059
Electrode belt, size M 8420058
Electrode belt, size L 8420057
Electrode belt, size XL 8420056
Electrode belt, size XXL 8420055
ECG electrode (pack of 50) 4527750
MEDIBUS cable (male/female) 8306488
MEDIBUS cable (female/female) 8416326
ADAP kit (option) 8420006
PressurePod 8424050

PulmoVista 500 part number: 8420000

Instructions for use PulmoVista 500 SW 1.3n 169


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170 Instructions for use PulmoVista 500 SW 1.3n


Index

Index

Numeric EELI trend . . . . . . . . . . . . . . . . . . . . . . . . 73, 74


Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
15-electrode mode . . . . . . . . . . . . . . . . . . . . . . . 63 Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Device combinations . . . . . . . . . . . . . . . . . . . 137
A Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Dialog windows . . . . . . . . . . . . . . . . . . . . . . . . 39
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . 123
ADAP Disk space . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
additional functions . . . . . . . . . . . . . . . . . . . 87 Display
Airway pressure unit . . . . . . . . . . . . . . . . . . . . 102 configure . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Displaying changes . . . . . . . . . . . . . . . . . . 68, 82
Applications page . . . . . . . . . . . . . . . . . . . . . . 104 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Artifact filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Dräger default settings . . . . . . . . . . . . . . . . . . 103
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Dynamic image . . . . . . . . . . . . . . . . . . . . . . . . 152

B E
Baseline frames . . . . . . . . . . . . . . . . . . . . . . . . 159 EIT data
refresh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
C EIT settings
configuring . . . . . . . . . . . . . . . . . . . . . . . . 100
C loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 Electrode belt . . . . . . . . . . . . . . . . . . . . . . . 25, 27
C loss HP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 attaching . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
C loss LP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 Electrode plane . . . . . . . . . . . . . . . . . . . . . . . 151
C win . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cable connectors . . . . . . . . . . . . . . . . . . . . . . . . 29 EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 137
Calibrating the touchscreen . . . . . . . . . . . . . . . . 40 Ending operation . . . . . . . . . . . . . . . . . . . . . . . 91
Calibration Environments of use . . . . . . . . . . . . . . . . . . . . . 18
restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Event
Clear data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Clinical users . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Cockpit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 F
hardware elements . . . . . . . . . . . . . . . . . . . 36
prepare . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 File handling . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . . 40 delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 File length . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Connections to IT networks . . . . . . . . . . . . . . . 139 Filter settings . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Contour of the ventilated area . . . . . . . . . . . . . . 97 Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . 17 Frame rate . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Copying to USB . . . . . . . . . . . . . . . . . . . . . . . . 108 Freeze display . . . . . . . . . . . . . . . . . . . . . . . . . 82
Cursor position . . . . . . . . . . . . . . . . . . . . . . . . . 73 Full-screen image . . . . . . . . . . . . . . . . . . . . . . . 69

D G
Data recording General WARNINGS and CAUTIONS . . . . . . . 11
configure . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Getting started . . . . . . . . . . . . . . . . . . . . . . . . . 49
settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Data review . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Date and time settings . . . . . . . . . . . . . . . . . . . 102

Instructions for use PulmoVista 500 SW 1.3n 171


Index

H Position of the user . . . . . . . . . . . . . . . . . . . . . . 48


Potential equalization . . . . . . . . . . . . . . . . . . . . 44
Header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Power supply module . . . . . . . . . . . . . . . . . . . . 24
PressurePod
I preparation . . . . . . . . . . . . . . . . . . . . . . . . . 47
Product specific page . . . . . . . . . . . . . . . . . . . 104
Image generation . . . . . . . . . . . . . . . . . . . . . . 142 PulmoVista 500
Impedance waveforms . . . . . . . . . . . . . . . . . . 153 components . . . . . . . . . . . . . . . . . . . . . . . . 20
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Install applications . . . . . . . . . . . . . . . . . . . . . . 104
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 R
Internal battery . . . . . . . . . . . . . . . . . . . . . . . . . 43 Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Reference function
L display data . . . . . . . . . . . . . . . . . . . . . . . . 67
parameters . . . . . . . . . . . . . . . . . . . . . . . . . 67
Language settings . . . . . . . . . . . . . . . . . . . . . . 102
waveform . . . . . . . . . . . . . . . . . . . . . . . . . . 67
LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Reprocessing
Literature references . . . . . . . . . . . . . . . . . . . . 167
classification . . . . . . . . . . . . . . . . . . . . . . . 119
Reprocessing personnel . . . . . . . . . . . . . . . . . . . 4
M Reprocessing procedures
Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 39 validated procedures . . . . . . . . . . . . . . . . 121
Main view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 ROI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Mains power supply . . . . . . . . . . . . . . . . . . . . . . 43 defining as layers . . . . . . . . . . . . . . . . . . . . 65
Mandatory reporting . . . . . . . . . . . . . . . . . . . . . 10 defining as quadrants . . . . . . . . . . . . . . . . . 66
MEDIBUS import setting as free . . . . . . . . . . . . . . . . . . . . . . . 66
configuring . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
MEDIBUS, MEDIBUS.X . . . . . . . . . . . . . . . . . . 46 RVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
configuring . . . . . . . . . . . . . . . . . . . . . . . . . . 98 RVD Ratio . . . . . . . . . . . . . . . . . . . . . . . . . 79, 81
connecting to a Dräger device . . . . . . . . . . . 47 RVD SD . . . . . . . . . . . . . . . . . . . . . . . . . . . 79, 81
trend display . . . . . . . . . . . . . . . . . . . . . . . . 99
Message-Cause-Remedy . . . . . . . . . . . . . . . . 110 S
Monitoring area . . . . . . . . . . . . . . . . . . . . . . . . . 38
Monitoring sessions . . . . . . . . . . . . . . . . . . . . . . 59 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Screen layout
configure . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
N Service . . . . . . . . . . . . . . . . . . . . . . . . . . 103, 127
New measurement . . . . . . . . . . . . . . . . . . . . . . 63 Service menu . . . . . . . . . . . . . . . . . . . . . . . . . 104
Numeric values . . . . . . . . . . . . . . . . . . . . . . . . 153 Service personnel . . . . . . . . . . . . . . . . . . . . . . . . 4
Signal check . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . . 84
O indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Operating concept . . . . . . . . . . . . . . . . . . . . . . . 35 Simulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Operating frequency . . . . . . . . . . . . . . . . . . . . 101 Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Status images . . . . . . . . . . . . . . . . . . . . . . . . . 152
Option Surface disinfectant . . . . . . . . . . . . . . . . . . . . 123
ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 87 SW versions page . . . . . . . . . . . . . . . . . . . . . 104
Switching off . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Switching on . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
P Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Patient cable . . . . . . . . . . . . . . . . . . . . . . . . 26, 28 System settings . . . . . . . . . . . . . . . . . . . . . . . 102
Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 country-specific . . . . . . . . . . . . . . . . . . . . . 102
Patient interface . . . . . . . . . . . . . . . . . . . . . . . . 25 System setup . . . . . . . . . . . . . . . . . . . . . . . . . . 94
attaching . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

172 Instructions for use PulmoVista 500 SW 1.3n


Index

T
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . 133
Thoracic contour . . . . . . . . . . . . . . . . . . . . . . . . 97
Time scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 3
Trolley
move . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
park . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
preparing . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Trunk cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

U
USB space . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
User interface . . . . . . . . . . . . . . . . . . . . . . . . . . 38

V
Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Z
Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . 76, 78, 80
Zoom in/zoom out . . . . . . . . . . . . . . . . . . . . 73, 75

Instructions for use PulmoVista 500 SW 1.3n 173


These instructions for use only apply to the
following device with the serial number filled in:
PulmoVista 500 SW 1.3n
Without the serial number filled in by Dräger,
these instructions for use are provided for
general information only and do not apply to a
specific device.
These instructions for use are provided for
customer information only and will only be
updated or exchanged upon customer request.

Manufacturer
Drägerwerk AG & Co. KGaA
Moislinger Allee 53 – 55
23542 Lübeck
Germany
+49 451 8 82-0
FAX +49 451 8 82-20 80
http://www.draeger.com

9511001 – GA 5667.100 en
© Drägerwerk AG & Co. KGaA
Edition: 1 – 2020-04
Dräger reserves the right to make modifications
to the medical device without prior notice.

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