Pulmovista-500 Operation Manual

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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 1.2n
instructions for use.
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,
new sequence of actions. e.g., ROI 1 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

Trademark Trademark owner


Medical Cockpit™ Dräger
Infinity® Dräger
PulmoVista™ Dräger
MEDIBUS™ Dräger
®
MEDIBUS.X Dräger
Buraton® Schülke+
®
Mikrobac BODE Chemie

2 Instructions for use PulmoVista 500 SW 1.2n


Safety information definitions

WARNING CAUTION
A WARNING statement provides important in- A CAUTION statement provides important infor-
formation about a potentially hazardous situa- mation about a potentially hazardous situation
tion which, if not avoided, could result in which, if not avoided, may result in minor or mod-
death or serious injury. 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.

Definition of target groups

For this product, users, service personnel, and Service personnel


experts are defined as target groups.
These target groups must have received instruction Service personnel are persons who are responsible
in the use of the product and must have the for the maintenance of the product.
necessary training and knowledge to use, install, Service personnel must be trained in the
reprocess, maintain, or repair the product. maintenance of medical devices and install,
The product must be used, installed, reprocessed, reprocess, and maintain the product.
maintained, or repaired exclusively by defined
target groups.
Experts

User Experts are persons who perform repair or complex


maintenance work on the product.
Users are persons who use the product in Experts must have the necessary knowledge and
accordance with its intended use. experience with complex maintenance work on the
product.

Abbreviations and symbols

For explanations refer to sections "Abbreviations"


and "Symbols" in chapter "Overview".

Instructions for use PulmoVista 500 SW 1.2n 3


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4 Instructions for use PulmoVista 500 SW 1.2n


Contents

Contents

For your safety and that of your patients. . . 7 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55


General safety information . . . . . . . . . . . . . . . . 8 Safety information for operation . . . . . . . . . . . 56
Product-specific safety information. . . . . . . . . . 11 Starting a new measurement . . . . . . . . . . . . . 57
Main view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Other views . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Freeze display . . . . . . . . . . . . . . . . . . . . . . . . 71
Indications/contraindications . . . . . . . . . . . . . . 16 Export screenshot . . . . . . . . . . . . . . . . . . . . . . 71
Environment of use. . . . . . . . . . . . . . . . . . . . . . 18 Marking events . . . . . . . . . . . . . . . . . . . . . . . . 72
Option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 75
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Additional functions provided by the option
ADAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 20
Ending operation . . . . . . . . . . . . . . . . . . . . . . . 80
Medical Cockpit (Infinity C500). . . . . . . . . . . . . 21
EIT module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 81
Power supply module (Infinity P2500) . . . . . . . 24
Patient interface . . . . . . . . . . . . . . . . . . . . . . . . 25 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Configuring the screen layout . . . . . . . . . . . . . 82
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Configuring EIT settings . . . . . . . . . . . . . . . . . 88
Configuring the system . . . . . . . . . . . . . . . . . . 90
Operating concept . . . . . . . . . . . . . . . . . . . . . 31 Configuring data recording . . . . . . . . . . . . . . . 94
Hardware elements . . . . . . . . . . . . . . . . . . . . . 32 Problem solving . . . . . . . . . . . . . . . . . . . . . . 97
Screen elements. . . . . . . . . . . . . . . . . . . . . . . . 34
Message – Cause – Remedy . . . . . . . . . . . . . 98
Assembly and preparation . . . . . . . . . . . . . . 37
Cleaning and disinfection. . . . . . . . . . . . . . . 105
Safety information for assembly and
preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Safety information for reprocessing. . . . . . . . . 106
Preparing the Cockpit . . . . . . . . . . . . . . . . . . . . 38 Reprocessing procedure . . . . . . . . . . . . . . . . . 108
Connecting the mains power supply. . . . . . . . . 39 Before reusing on patient . . . . . . . . . . . . . . . . 109
Using the trolley . . . . . . . . . . . . . . . . . . . . . . . . 40
Intrahospital transport . . . . . . . . . . . . . . . . . . . 41 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Preparation for using the MEDIBUS or Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . . 42 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Position of the user. . . . . . . . . . . . . . . . . . . . . . 43 Preventive maintenance . . . . . . . . . . . . . . . . . 114
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 45
Switching on PulmoVista 500 . . . . . . . . . . . . . . 46 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Disposing of the medical device . . . . . . . . . . . 116
Attaching the patient interface . . . . . . . . . . . . . 49 Disposing of batteries . . . . . . . . . . . . . . . . . . . 116
Connecting the trunk cable. . . . . . . . . . . . . . . . 52
Monitoring sessions . . . . . . . . . . . . . . . . . . . . . 52

Instructions for use PulmoVista 500 SW 1.2n 5


Contents

Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 117


Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 118
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Performance characteristics . . . . . . . . . . . . . . . 118
Operating data . . . . . . . . . . . . . . . . . . . . . . . . . 119
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Communication interfaces on Medical
Cockpit Infinity C500 . . . . . . . . . . . . . . . . . . . . 121
Device combinations . . . . . . . . . . . . . . . . . . . . 121
EMC declaration. . . . . . . . . . . . . . . . . . . . . . . . 121
Connections to IT networks . . . . . . . . . . . . . . . 124

Principles of operation . . . . . . . . . . . . . . . . . 125


Image generation . . . . . . . . . . . . . . . . . . . . . . . 126
Information displayed by PulmoVista 500 . . . . 136
Definition of baseline frames . . . . . . . . . . . . . . 142
Definitions for color scales and scales of
impedance waveforms . . . . . . . . . . . . . . . . . . . 145
Principles of breath detection and
determination of the tidal rate. . . . . . . . . . . . . . 147
Literature references . . . . . . . . . . . . . . . . . . . . 148

List of accessories . . . . . . . . . . . . . . . . . . . . . 151

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

6 Instructions for use PulmoVista 500 SW 1.2n


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
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Electromagnetic compatibility (EMC) . . . . . . . . 10
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Storing the instructions for use . . . . . . . . . . . . . 10

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


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

Instructions for use PulmoVista 500 SW 1.2n 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. experts. Repair and complex maintenance car-
ried out on the medical device must be per-
formed by experts.
Strictly follow these instructions for use If the above is not complied with, medical de-
vice failure and patient injury may occur. Ob-
WARNING serve chapter "Service".
Risk of incorrect operation and of incorrect Dräger recommends that a service contract is
use obtained with DrägerService and that all re-
pairs are performed by DrägerService. For
Any use of the medical device requires full un-
maintenance Dräger recommends the use of
derstanding and strict observation of all sec-
authentic Dräger repair parts.
tions of these instructions for use. The medi-
cal device must only be used for the purpose
specified under "Intended use" on page 16.
Accessories
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
WARNING
use and all statements on medical device la-
bels. Failure to observe these safety informa- Risk due to incompatible accessories
tion statements constitutes a use of the medi- Dräger has tested only the compatibility of ac-
cal device that is inconsistent with its intend- cessories listed in the current list of accesso-
ed use. ries. If other, incompatible accessories are
used, there is a risk of patient injury due to
medical device failure.
Dräger recommends that the medical device is
only used together with accessories listed in
the current list of accessories.

8 Instructions for use PulmoVista 500 SW 1.2n


For your safety and that of your patients

Connected devices – Potentially negative effects on patients with


different underlying diseases
WARNING Medical device modification or misuse can be
Risk of electric shock and of device malfunc- dangerous.
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.

Safe connection with other electrical


equipment

CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these instructions for use or these assembly in-
structions must only be made when approved by
each respective manufacturer.

Patient safety

The design of the medical device, the


accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to 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

Instructions for use PulmoVista 500 SW 1.2n 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 121). 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.
WARNING
To prevent malfunctions, observe the follow-
ing measures and train the relevant person- Risk of image distortion which may lead to
nel: wrong therapeutic decisions
– Observe the ESD protective measures. If images or waveforms are distorted, check if
Such measures may include wearing anti- electromagnetic interference is compromis-
static clothing and shoes, touching a po- ing the function of the medical device and, if
tential equalization pin before and while possible, avoid the interference.
making the connection, or using electrical- Other equipment may interfere with the func-
ly insulating and antistatic gloves. tion of the medical device, even if the other
– Observe the requirements for the electro- equipment complies with CISPR emission re-
magnetic environment. Observe the fol- quirements.
lowing section: "Electromagnetic environ-
ment" (page 122).
Training

Training for users is available from the Dräger


organization responsible (see www.draeger.com).

Storing the instructions for use

CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.

10 Instructions for use PulmoVista 500 SW 1.2n


For your safety and that of your patients

Product-specific safety information

WARNING WARNING
To properly use this medical device, the user Risk of device malfunction
must obtain a full understanding of the perfor-
If the patient interface was connected during
mance characteristics of this medical device
defibrillation despite the warning, all parts of
prior to use by carefully reading these Instruc-
the patient interface, including the patient ca-
tions for Use.
ble and the trunk cable, must be replaced.

WARNING
WARNING
Risk of incorrect use
Risk of electric shock and of device malfunc-
This medical device must only be used by tion
physicians, respiratory therapists, and nurs-
Do not use the medical device in environ-
es, who have received training on the use of
ments that are subject to conductive pollu-
this medical device.
tion, e.g., metal or graphite particles or dust,
or continuous conductivity, e.g., wet condi-
WARNING tions.
Risk of device malfunction
Only devices listed in these instructions for WARNING
use may be connected to the medical device. Risk of fire and of explosion
Otherwise, the correct functioning of this
Do not use the medical device in areas where
medical device may be compromised.
combustible or explosive gas mixtures are
likely to occur.
WARNING
Risk of wrong therapeutic decisions WARNING
Do not use this medical device as the sole ba- Risk of fire
sis for diagnosis or therapeutic decisions.
Do not use the medical device in an oxygen-
enriched environment.
WARNING
Danger of personal injury WARNING
Modifications to the medical device may Risk of fire
cause malfunctioning.
Do not position the medical device close to an
Do not modify this medical device without au- oxygen outlet which opens to the ambient at-
thorization by Dräger. mosphere. Keep the medical device at least
1 m (3.3 ft) in front of the O2 outlet and 20 cm
WARNING (7.9 in) to the side of the O2 outlet.
Risk of ineffective defibrillation
WARNING
Remove all parts of the patient interface from
Risk of device malfunction
the patient before cardiac defibrillation.
Do not use the medical device outside the
specified ambient conditions.

Instructions for use PulmoVista 500 SW 1.2n 11


For your safety and that of your patients

WARNING WARNING
Risk of electric shock and of device malfunc- Risk of electric shock and of device malfunc-
tion tion
Avoid the ingress of liquids. Do not use the medical device in areas outside
the specification for electrical supply as stat-
WARNING ed in the section "Operating data"
on page 119.
Risk of damage to the device
If liquid is accidentally spilled on the medical WARNING
device, disconnect the medical device from
Risk of image distortion and impaired func-
the mains power supply. Contact service per-
tional integrity of other bioimpedance measur-
sonnel.
ing devices and risk of cardiac arrhythmia

WARNING Do not use the medical device in conjunction


with other bioimpedance measuring devices.
Risk of device malfunction
Do not expose the medical device to direct ra- WARNING
dioactive radiation.
Risk of device malfunction

WARNING Do not use the medical device in the presence


of strong magnetic fields, e.g., MRT.
Risk of device malfunction
Do not directly expose any part of the medical WARNING
device, except the patient interface, to X-rays.
Risk of skin burns

WARNING Disconnect the electrode belt from the device


or from the patient during electricity-based
Risk of device malfunction
therapies such as electrosurgery or electro-
If the ventilation slots or heat exchange sur- cautery.
faces of the medical device are covered, the
air flow is blocked and the medical device may WARNING
overheat.
Risk of patient contamination
Do not cover the ventilation slots and heat ex-
Do not attach the electrode belt to the sterile
change surfaces of the medical device.
part of the patient’s body where surgery is be-
ing performed.
WARNING
Risk of electric shock CAUTION
Do not open the housing of the medical de- X-rays can impair the quality of EIT images.
vice.
Only operate the medical device at a distance of
at least 1.5 m (4.9 ft) from X-ray devices.
WARNING
Risk of electric shock and of device malfunc-
tion
Only connect passive storage media without
their own power supply to the USB port.

12 Instructions for use PulmoVista 500 SW 1.2n


For your safety and that of your patients

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 EKG, 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. A software update must be
performed by experts.

Essential performance

PulmoVista 500 displays EIT dynamic images and


changes of end-expiratory lung impedance in a way
which allows the informed user to interpret the
displayed information correctly.
PulmoVista 500 ensures that the currents passed
to the patient are within acceptable limits.
PulmoVista 500 is not a life-supporting device in
the sense of IEC 60601-1-2.

Instructions for use PulmoVista 500 SW 1.2n 13


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14 Instructions for use PulmoVista 500 SW 1.2n


Application

Application

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

Indications/contraindications . . . . . . . . . . . . 16
Medical indications . . . . . . . . . . . . . . . . . . . . . . 16
Medical contraindications . . . . . . . . . . . . . . . . . 16

Environment of use . . . . . . . . . . . . . . . . . . . . 18

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

Instructions for use PulmoVista 500SW 1.2n 15


Application

Intended use

PulmoVista 500 is a non-invasive monitoring PulmoVista 500 displays this information in the
device used as a tool for assessing the patient's following form:
distribution of ventilation and changes of lung – Real-time cross-sectional EIT dynamic images
volume. – Cross-sectional EIT status images
– Real-time impedance waveforms
PulmoVista 500 is intended to perform thoracic
– Derived numeric parameters
bioimpedance measurements by applying the
– Trend data
technique of electrical impedance tomography
(EIT). PulmoVista 500 is intended for use on patients with
a chest circumference ranging from 70 cm (27.6 in)
PulmoVista 500 displays regional information on
to 150 cm (59 in).
ventilation-related changes of air content within the
electrode plane. PulmoVista 500 must only be used by qualified and
trained medical personnel.
PulmoVista 500 displays regional information on
changes of end-expiratory lung volume within the The displayed information is only intended to serve
electrode plane. as a supplementary source for the assessment of
lung function.

Indications/contraindications

Medical indications Medical contraindications

PulmoVista 500 is intended for use on patients WARNING


whose regional distribution of ventilation and of
Risk of pacemaker impairment
lung volume are of clinical interest. To ensure
proper contact between the electrodes and the skin Do not use PulmoVista 500 on patients with
during the measurements, patients must be in a pacemaker.
supine, prone, or lateral position. In a seated
position, the patient must lean against a backrest. WARNING
Risk of defibrillator impairment
Do not use PulmoVista 500 on patients with an
implantable cardioverter-defibrillator.

WARNING
Risk of incorrect measurements and image
distortions
Do not use PulmoVista 500 on patients with
other electrically active implants which are
likely to interfere with PulmoVista 500.

16 Instructions for use PulmoVista 500SW 1.2n


Application

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
Risk of image distortion
Do not use PulmoVista 500 on patients where
the electrodes cannot provide sufficient elec-
trical contact to the skin of the patient, e.g.,
due to wound dressings.

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
Risk of image distortion
Do not use PulmoVista 500 on patients with
uncontrolled body movements.

WARNING
Safety and effectiveness have not been estab-
lished for pregnant women or for children un-
der 5 years of age.
Do not use PulmoVista 500 on these patients.

NOTE
The measurement accuracy in patients with a tidal
volume of less than 200 mL has not been validat-
ed.

NOTE
There is a risk of image distortion in patients with a
body mass index higher than 50.

Instructions for use PulmoVista 500SW 1.2n 17


Application

Environment 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 76.

18 Instructions for use PulmoVista 500SW 1.2n


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 . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Patient cable. . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Trunk cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 27
Abbreviations in the PulmoVista 500
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Abbreviations in the instructions for use. . . . . . 28
Abbreviations for labeling . . . . . . . . . . . . . . . . . 28

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Instructions for use PulmoVista 500 SW 1.2n 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 1.2n


Overview

Medical Cockpit (Infinity C500)

The Medical Cockpit, hereafter referred to as the


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 1.2n 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 1.2n


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 1.2n 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 Principles of operation


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

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

24 Instructions for use PulmoVista 500 SW 1.2n


Overview

Patient interface

The patient interface is made up of the following


components:
– Electrode belt
– Reference electrode
– Patient cable
– Trunk cable

Electrode belt

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 readily
identifiable by different colors and a size label. See
E F E
Page 49.

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 1.2n 25


Overview

Patient cable Trunk cable

NOTE
The patient cable is specifically designed for the A
detection of very low voltages. Due to its sophisti-
cated nature, the patient cable is very delicate and
must be handled with care. Avoid kinking, stretch-
ing, or twisting the cable.

The patient cable has 16 equally spaced serially


numbered snaps to connect to the electrode studs B

R
on the electrode belt. One end of the patient cable
has a reference electrode snap. The other end of
the patient cable terminates in a snap for the C
closure stud of the electrode belt. L

016
The patient cable is available in 5 sizes, A Trunk cable plug
corresponding to each electrode belt size. The
B Right patient cable plug, green colored,
snaps on the patient cable are color-coded to
labeled R
match the corresponding electrode belt.
C Left patient cable plug, red colored, labeled L
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 1.2n


Overview

Abbreviations

Abbreviations in the PulmoVista 500 software

Abbreviation Explanation Abbreviation Explanation


/min Per minute PEEP Positive end-expiratory pressure
ADAP Advanced Data Analysis Pack- PIP Peak inspiratory pressure
age Ref Cursor Ref
C Cursor C Ref Reference
CL Compliance loss ROI Region of interest
(decrease in compliance)
RVD Regional ventilation delay
CL HP Compliance loss towards higher (regional delay during ventila-
PEEP levels (decrease in com- tion)
pliance with increasing PEEP
levels) RVD Ratio Ratio of the RVD pixels to the to-
tal number of ventilated pixels
CL LP Compliance loss towards lower
PEEP levels (decrease in com- RVD SD RVD standard deviation
pliance with decreasing PEEP (standard deviation of the RVD)
levels) s Second
cmH2O Centimeters of water Ti Inspiratory time
1 cmH2O = approx. 1 mbar
Tidal rate Tidal rate per minute
CW Compliance win
TV global Global tidal variation
(increase in compliance)
TV ROI Regional tidal variation
dB Decibel
Vol. Volume
EIP End-inspiratory pressure
VT Tidal volume
EELI global Global change of end-expiratory
lung impedance MEDIBUS abbreviations can be found in the
EELI ROI Regional change of end-expira- document "MEDIBUS for V and VN ventilators"
tory lung impedance (9039527).
IP address Internet protocol address MEDIBUS.X abbreviations can be found in the
kHz Kilohertz document "Profile Definition MEDIBUS.X"
(9052608).
mbar Millibar
Additional MEDIBUS data abbreviations:
min Minute
mL Milliliter I:E Ratio of inspiratory time to expi-
mmHg Millimeters of mercury ratory time

MTV global Global minute tidal variation V Volume

MTV ROI Regional minute tidal variation


Paw Airway pressure

Instructions for use PulmoVista 500 SW 1.2n 27


Overview

Abbreviations in the instructions for use

Abbreviation Explanation Abbreviation Explanation


A Ampere SELV Safety extra low voltage
AC Alternating current
BF Body floating Abbreviations for labeling
CISPR Comité international spécial des
perturbations radioélectriques
Abbreviation Explanation
(Special International Commit-
tee on Radio Interference) C Closure snap
cm Centimeter IPX Degree of protection against in-
gress of water
COM1 Communication port 1
L Left
CT Computer tomography
R Right
DC Direct voltage
Ref Reference electrode snap
EEG Electroencephalogram
EELI End-expiratory lung impedance
EIT Electrical impedance tomogra-
phy
ECG Electrocardiogram
EMG Electromyography
EMC Electromagnetic compatibility
EOG Electrooculogram
ESD Electrostatic discharge
FEM Finite element method
GHz Gigahertz
RF Radio frequency
Hz Hertz
in Inch
LED Light-emitting diode
MB Megabyte
MEDIBUS Dräger communication protocol
for medical devices
MRT Magnetic resonance imaging
Rel. Relative
SIM Subscriber Identity Module
USB Universal serial bus
V Voltage

28 Instructions for use PulmoVista 500 SW 1.2n


Overview

Symbols

Symbol Explanation Symbol Explanation


On/Off key XXL Extra extra large

Mains power supply Temperature during storage


(AC power)
Relative humidity during storage
Battery indicator
Caution! Observe important safety-rel- Ambient pressure during storage
evant information and precautionary
measures in the instructions for use. System cable port for connection of the
Follow instructions for use. EIT module to the power supply mod-
ule
ESD (Electrostatic discharge) warning EIT Trunk cable port for connection of the
symbol trunk cable to the EIT module
Observe disposal instructions TEST Test connectors

China RoHS mark


Applied part type BF
Connection for potential equalization
Manufacturer bonding at the bottom of the power
supply unit
20xx Year of manufacture
Keep away from rain
Risk of medical device tipping over
when the medical device is pushed Identification of packaging material
02

Non-ionizing electromagnetic radiation


This end up
Protective earth
Non-stackable
Potential equalization connector

USBport Fragile
Serial connection
Use by
SN Serial number

Part number, sometimes including revi-


~ Waveform (symbol on the screen)
REF
sion index Maximum weight
max. 44 kg (97 lbs)

S Small
Sys System connector at the Cockpit
Con
M Medium
Audio paused key (not used)
L Large

XL Extra large

Instructions for use PulmoVista 500 SW 1.2n 29


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30 Instructions for use PulmoVista 500 SW 1.2n


Operating concept

Operating concept

Hardware elements. . . . . . . . . . . . . . . . . . . . . 32
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
LEDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Screen elements . . . . . . . . . . . . . . . . . . . . . . . 34
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Monitoring area. . . . . . . . . . . . . . . . . . . . . . . . . 34
Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 35
Dialog windows. . . . . . . . . . . . . . . . . . . . . . . . . 35
Button and tab colors . . . . . . . . . . . . . . . . . . . . 36
Calibrating the touchscreen . . . . . . . . . . . . . . . 36

Instructions for use PulmoVista 500 SW 1.2n 31


Operating concept

Hardware elements

Overview Rotary knob backlight


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

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

A A B
027

011

Using the rotary knob


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

32 Instructions for use PulmoVista 500 SW 1.2n


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 Principles of operation


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 Batteriy >80 % capacity
Solid yellow Battery 80 % capacity
Flashes yellow Fault

Instructions for use PulmoVista 500 SW 1.2n 33


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 name (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 58.


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

34 Instructions for use PulmoVista 500 SW 1.2n


Operating concept

Main menu bar Dialog windows

The main menu bar is located along the right edge Dialog windows consist of one or more pages,
of the screen and is always visible. It consists of the which may in turn have subpages. Pages and
following buttons: subpages are accessed by touching the
corresponding horizontal or vertical tab. Dialog
windows contain elements for operating the system
A and inform the user of current settings. Dialog
B windows can be opened by touching a button in the
C main menu bar.
D
E A
B
F C C C C

G D
H
I D
502

A Views..., for accessing the predefined views D


– Main
– Full-screen image
– End-insp. trend
– EELI trend
– Diagnostics
For details, see "Main view" on page 58.
B Freeze display, see "Freeze display"
on page 71
C Export screenshot, see "Export screenshot"
on page 71

505
D Mark event..., see "Event marking" on page 72 A Dialog window title
E Data review... (requires the ADAP option), see B Button for closing the dialog window
"Data review" on page 76
C Horizontal tabs
F Record (requires the ADAP option), see "Data
recording" on page 76 D Vertical tabs

G Signal check... for checking the electrode


resistance, see "Signal quality" on page 72
H System setup... for configuring the system
functions, see "Configuration" on page 81
I Start/ Standby... for selecting standby mode or
starting the measurement, see "Standby mode"
on page 75
Touching a button opens the corresponding dialog
window or activates the corresponding function.

Instructions for use PulmoVista 500 SW 1.2n 35


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
selection. 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
selection due to a certain mode
or required connection.

If a selection is not confirmed within 15 seconds, it


will revert to the previous setting.

36 Instructions for use PulmoVista 500 SW 1.2n


Assembly and preparation

Assembly and preparation

Safety information for assembly and


preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Preparing the Cockpit . . . . . . . . . . . . . . . . . . 38


Tilting the Cockpit . . . . . . . . . . . . . . . . . . . . . . . 38
Turning the Cockpit . . . . . . . . . . . . . . . . . . . . . 38

Connecting the mains power supply . . . . . . 39

Using the trolley . . . . . . . . . . . . . . . . . . . . . . . 40


Parking the trolley. . . . . . . . . . . . . . . . . . . . . . . 40

Intrahospital transport . . . . . . . . . . . . . . . . . . 41
Before transportation . . . . . . . . . . . . . . . . . . . . 41
Moving the trolley . . . . . . . . . . . . . . . . . . . . . . . 41

Preparation for using the MEDIBUS or


MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . 42
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Connecting PulmoVista 500 to a Dräger
device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Position of the user . . . . . . . . . . . . . . . . . . . . 43

Instructions for use PulmoVista 500 SW 1.2n 37


Assembly and preparation

Safety information for assembly and preparation

WARNING WARNING
Risk of device malfunction, of electric shock, Risk of device malfunction, of electric shock,
and of mechanical instability and of mechanical instability
Do not install or modify PulmoVista 500. Only If there are any signs of damage, do not use
assemblies that are described in these in- PulmoVista 500.
structions for use may be modified by the us- Contact DrägerService.
er.
Only service personnel may assemble
PulmoVista 500. For relevant information,
contact the local DrägerService support.

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.

38 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 39


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.

40 Instructions for use PulmoVista 500 SW 1.2n


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
Danger 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 1.2n 41


Assembly and preparation

Preparation for using the MEDIBUS or MEDIBUS.X protocol

Overview The following MEDIBUS or MEDIBUS.X data is


recorded as part of data recording (requires the
PulmoVista 500 can display data from Dräger option ADAP):
devices using the MEDIBUS- or MEDIBUS.X – All measured values
protocol. – 3 real-time waveforms
Only connect the following Dräger devices1) to the
COM 1 port of PulmoVista 500:
Connecting PulmoVista 500 to a Dräger
– Evita 2 dura
– Evita 4, Evita 4 edition device
– Evita XL
– Evita V300 Prerequisite: PulmoVista 500 is in standby mode.
– Evita Infinity V500 Use the appropriate MEDIBUS cable (see "List of
– Babylog VN500 accessories" on page 151) to connect
– Savina 300 PulmoVista 500 to the Dräger device in use.
The devices listed for connection to the serial port Infinity C500 (MS18746):
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.
The MEDIBUS or MEDIBUS.X interface must only
be connected to the devices specified by Dräger by
B
service personnel.
The following data can be displayed:
A
– Volume waveform (Main view)
030

– Tidal volume parameter (Main view) Infinity C500 (MK31500):

– 3 configurable parameters, as defined in the


system setup
(view End-insp. trend, EELI trend)
– The parameters PEEP and EIP (or PIP if EIP is
not available) in the Diagnostics view
– All MEDIBUS parameters on the Data review
page
B A
136

1 Not all products are commercially available worldwide.

42 Instructions for use PulmoVista 500 SW 1.2n


Assembly and preparation

1 Insert the connector (A) into the COM 1 port (B)


at the back of the Cockpit.
2 Attach the other connector to the Dräger device.
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 data import" on page 86.

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

Instructions for use PulmoVista 500 SW 1.2n 43


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44 Instructions for use PulmoVista 500 SW 1.2n


Getting started

Getting started

Switching on PulmoVista 500 . . . . . . . . . . . . 46

Device check. . . . . . . . . . . . . . . . . . . . . . . . . . 47
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Preparing the device check . . . . . . . . . . . . . . . 47
Performing the device check . . . . . . . . . . . . . . 48

Attaching the patient interface . . . . . . . . . . . 49


Preparing the patient . . . . . . . . . . . . . . . . . . . . 49
Attaching the electrode belt . . . . . . . . . . . . . . . 49

Connecting the trunk cable . . . . . . . . . . . . . . 52

Monitoring sessions. . . . . . . . . . . . . . . . . . . . 52
Continuing the monitoring session . . . . . . . . . . 53
Starting a new monitoring session . . . . . . . . . . 53

Instructions for use PulmoVista 500 SW 1.2n 45


Getting started

Switching on PulmoVista 500

WARNING The progress bar indicates the progress of the


startup.
Risk of electric shock and of device malfunc-
tion At the end of the startup, PulmoVista 500 displays
the Start/Standby dialog window. The
Do not use the medical device if condensation
Start/Standby (B) page is selected.
is present.
PulmoVista 500 is in standby mode.
.

CAUTION Start/Standby
After extended exposure to a cold environment,
acclimatize the device carefully so that condensa-
B F
tion cannot form on the electronic parts and does
not damage the device.
C D
Infinity C500 (MS18746)
E
A

Infinity C500 (MK31500)

A
018

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


All LEDs are tested. After initialization the startup
screen is displayed.
500

The Start/Standby page provides the following


buttons and tabs:
– Start (C), to start measurement, see page 53
– Standby (D), to switch to standby mode,
see page 75
– New patient (E), to start a new monitoring
session, see page 53
– Device check (F), to open the device check
page, see page 47
506

46 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 47


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.

48 Instructions for use PulmoVista 500 SW 1.2n


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.
"Cleaning and disinfection" on page 105. Ob-
serve 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 excessive leakage current
If more than four additional applied parts from CAUTION
other devices are used together with Risk of skin injury
PulmoVista 500, make sure that the overall pa-
tient leakage current is below the safety limit Do not use the electrode belt for more than
specified in the standard IEC 60601-1. 24 hours consecutively on the same patient.

CAUTION CAUTION
Avoid damage to the cables by gripping the plugs Danger of unstable circulation
when disconnecting parts of the patient cable as- Positioning the electrode belt may lead to hemo-
sembly instead of pulling on the cables. dynamic instability in patients with unstable circu-
lation.
Do not attach the electrode belt to patients where
Preparing the patient this may pose a risk of hemodynamic instability.
1 Clean the respective skin areas properly.
Ensure that the respective skin surface is free of CAUTION
body fluids or material which may impede Ensure that perspiration or gel does not establish
electrode contact. a conductive connection between the closure stud
of the electrode and the skin of the patient. This
2 Remove chest hair as necessary to ensure could impair the measurement quality.
proper electrode contact.

Instructions for use PulmoVista 500 SW 1.2n 49


Getting started

Selecting the belt size 1 Connect snap 1 (A) of the patient cable to
stud 1 (B) of the electrode belt. Ensure the
The size labels and color coding of the electrode
orientation of the cable over the stud is
belt and the patient cable match. The following
maintained as illustrated and as marked on the
table shows size and color according to chest
electrode belt.
circumference.
2 Connect all other snaps in numerical order to
Chest circumference Color Size the studs of the electrode belt. Make sure that
70 to 85 cm Medium blue S the patient cable changes direction above each
(28 to 33 in) stud.
80 to 96 cm Dark blue M
(31 to 38 in)
92 to 110 cm Dark red L
(36 to 43 in)
106 to 127 cm Gray XL
(42 to 50 in) C

005
124 to 150 cm Violet XXL
(49 to 59 in) Moisture from the skin usually results in sufficient
conductivity between the skin and the electrodes a
1 Estimate the chest circumference at the height few minutes after the belt has been applied. If
of the 4th to 6th intercostal space at the sufficient conductivity is not achieved, electrode gel
medioclavicular line. or spray may be applied to the black electrode
surface areas (C) on the electrode belt.
2 Select a suitable electrode belt. The attached
electrode belt must be just tight enough to 3 If the skin is obviously dry, it is recommended to
provide sufficient contact between the skin and apply electrode gel or spray to the electrodes
the electrodes. If possible, select a belt size that before the electrode belt is applied.
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 of the same size.

Connecting the patient cable to the electrode


belt
Connect the patient cable before attaching the
electrode belt to the patient.

1 16
B

1 16
A
006

50 Instructions for use PulmoVista 500 SW 1.2n


Getting started

Attaching the electrode belt on the patient

Male Female

2
140
С

1 Place the electrode belt with the patient cable


E

007
connected at the height of the 4th to 6th
intercostal space (medioclavicular line) around 4 Close the electrode belt so that all electrodes
the chest of the patient. For female patients have close contact with the skin.
place the electrode belt so upon the chest in Depending on the position of the belt closure, the
such a way that its position matches EIT image may change slightly. With increasing
approximately the 5th intercostal space. distance between electrodes 1 and 16 the left and
Ensure that the left-right orientation of the electrode right ventral parts of the EIT image close up. Where
belt is correctly maintained. The red patient cable wound dressings or other material prevent skin
port must be to the patient's left and the green contact with all 16 electrodes, EIT measurements
patient cable port to the patient's right. can be performed with only 15 electrodes.
However, at least 15 electrodes must have
effective contact with the skin.
5 Connect the closure snap (E) to the closure
D stud (F).

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.
3 Ensure that the electrode belt is positioned so
1
С

that electrodes 1 and 16 are equidistant from


the sternal edge.
Wherever possible attach the electrodes with an
equal distance to each other. Irregular electrode G H
distances affect the quality of the EIT data. Ref
009

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 1.2n 51


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 73. 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
– Starting a new monitoring session
Prerequisite: The Start/Standby (A) page is open.
PulmoVista 500 is in standby mode.
500

52 Instructions for use PulmoVista 500 SW 1.2n


Getting started

Continuing the monitoring session

 Touch the Start button (B).


Trend data and reference data from the last session
are saved. Trend data is not collected while
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 (C). Press the
rotary knob to confirm.
2 Touch the Start button (B).
The new measurement starts.

Instructions for use PulmoVista 500 SW 1.2n 53


This page intentionally left blank

54 Instructions for use PulmoVista 500 SW 1.2n


Operation

Operation

Safety information for operation. . . . . . . . . . 56

Starting a new measurement. . . . . . . . . . . . . 57


15-electrode mode . . . . . . . . . . . . . . . . . . . . . . 57

Main view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Setting ROIs . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Displaying reference data. . . . . . . . . . . . . . . . . 61
Deleting reference data . . . . . . . . . . . . . . . . . . 62

Other views . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Selecting a view . . . . . . . . . . . . . . . . . . . . . . . . 63
Full-screen image . . . . . . . . . . . . . . . . . . . . . . . 63
End-inspiratory trend . . . . . . . . . . . . . . . . . . . . 64
EELI trend . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Freeze display. . . . . . . . . . . . . . . . . . . . . . . . . 71

Export screenshot . . . . . . . . . . . . . . . . . . . . . 71

Marking events . . . . . . . . . . . . . . . . . . . . . . . . 72

Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . 72
Signal quality indicator . . . . . . . . . . . . . . . . . . . 72
Signal check . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 75
Activating standby mode . . . . . . . . . . . . . . . . . 75

Additional functions provided by the


option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Data recording . . . . . . . . . . . . . . . . . . . . . . . . . 76
Data review. . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Ending operation . . . . . . . . . . . . . . . . . . . . . . 80
Switching off the system. . . . . . . . . . . . . . . . . . 80
Removing the patient interface. . . . . . . . . . . . . 80
Disconnecting PulmoVista 500 from a
Dräger device . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Instructions for use PulmoVista 500 SW 1.2n 55


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 lung edema
– Adiposity
– Temperature changes
For more information refer to "Signal quality"
on page 72 and "General considerations"
on page 131.

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.

56 Instructions for use PulmoVista 500 SW 1.2n


Operation

Starting a new measurement

 Touch the Start button on the Start/Standby 15-electrode mode


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 57 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 89)
– Automatic adjustment of the scales of EIT To restore the 16-electrode mode see page 98.
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 is displayed
which is 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 1.2n 57


Operation

Main view

The Main view is the standard monitoring page. C Global impedance waveform – 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, the volume waveform imported by
the electrode plane. Waveforms represent the
MEDIBUS or MEDIBUS.X
volume changes within the electrode plane or parts
of it over time. Parameters represent regional D Regional impedance waveforms – represent
volume changes as a percentage of the whole. relative impedance changes of the defined ROI
Regions of interest (ROIs) are defined for all views E Blue markers – represent beginning and end of
from this page. inspiration
The Main view displays the following: F Parameter field – displays the tidal rate

E I F
NOTE
The tidal rate determined by PulmoVista 500 de-
C
A G pends on user-selected filter settings and thus
may not reflect the respiratory rate of the patient.
D H For this reason, the determination of the Tidal rate
is not defined as a measuring function in the sense
B
D H of the Directive 93/42/EEC concerning Medical
K J Devices.
D H
G Parameter field – displays the following:
D H – Global tidal variation TV global or global
509

minute tidal variation MTV global


A Dynamic image – shows impedance changes in depending on the selected status image,
a caudo-cranial image referenced to a dynamic always defined as 100 %
baseline. – Tidal volume VT, if available and selected in
System setup, see page 87
B Status Image, as selected in System setup,
see page 85 H Parameter fields – display the regional tidal
– Tidal image: Differential image of the end of variation or regional minute tidal variation as a
inspiration compared to the beginning of percentage of TV global or MTV global
inspiration, which represents regional depending on the selected status image and the
distribution of impedance changes of the defined ROI
last detected breath. Numeric values, see page 137.
– Minute image: Tidal images averaged over
the last minute I Reference button Ref

Electrode positions are represented in the dynamic J Button Set ROI... for setting the ROI
images and status images. If the skin-electrode K Button Enhance contrast – While this button is
impedance is too great, the corresponding pressed, the colors in all images are displayed
electrode is displayed in red. If the skin-electrode more vividly in particular to support the
impedance is too unstable, the corresponding recognition of regions with oppositely phased
electrode is displayed in white. impedance changes.

58 Instructions for use PulmoVista 500 SW 1.2n


Operation

Displaying reference data The Set ROI... page provides the following buttons
and tabs:
See "Displaying reference data" on page 61.
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 or End-insp. trend view is G Free – single ROIs can be moved
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 row (C). Set the
E F G value by turning the rotary knob and press to
confirm.
3 Touch the button in the Height row (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 touchscreen 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 1.2n 59


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

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

60 Instructions for use PulmoVista 500 SW 1.2n


Operation

Displaying reference data When the status image is set to Minute, the
reference waveform is made up of the impedance
Prerequisite: The Main view is open. waveform of the breaths within the last minute
before the Ref button was pressed. In this case, the
 Touch the Ref button (A). duration of the reference waveform displayed
depends on the selected time scale. When the time
A scale is set to less than one minute, only the first
D B part of the reference waveform is displayed. When
the time scale is set to longer than one minute, then
D E the reference waveform is made up of repeated
sequences of one minute, or part thereof.
D E
For setting the status image, see page 85.
D E
D E Reference parameters
C
Reference parameters represent the distribution of
E
520

regional (minute) tidal variations in the reference


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

For setting the status image, see page 85. If reference data are displayed and filter settings
are changed, the changed filter settings will not
affect the displayed reference data.
Reference waveforms
When the status image is set to Tidal, the reference
waveform is made up of repeated sequences of the
impedance waveform of the reference breath. The
reference breath is the last detected breath before
the Ref button was pressed.

Instructions for use PulmoVista 500 SW 1.2n 61


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 145.
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.

62 Instructions for use PulmoVista 500 SW 1.2n


Operation

Other views

The display of the measured EIT data can be The Full-screen image view displays the following:
changed by the user in the Views dialog window.
The following views can be selected: AB D
A E
Views E
A E
B E
C
C E
D E

518
E A Small format image, according to selection in
System setup
511

A Main B Global impedance waveform

B Full-screen image C Large format image, as selected in System


setup
C End-insp. trend
D Button Ref
D EELI trend
E Parameter fields as in the Main
E Diagnostics

Displaying reference data


Selecting a view  See "Displaying reference data" on page 61.

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


2 Touch the button to select the desired view.
3 Touch the X button to close the dialog window
or wait for the Views dialog window to close
automatically after a few seconds.

Full-screen image

The Full-screen image view provides a large


format view of the status image or dynamic image,
as selected in System setup, see page 82. The
image not selected for large format viewing is
shown in small format.

Instructions for use PulmoVista 500 SW 1.2n 63


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. – MEDIBUSor MEDIBUS.X data, if MEDIBUS
trend view the differences between these two or MEDIBUS.X is available as selected in
status images are displayed. These can be System setup, see page 86
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 or MEDIBUS.X trend parameters, if
Zero change No difference between values MEDIBUS or MEDIBUS.X is available as
at Ref and C selected in System setup, see page 86
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 chang- Value at C is less than the val- L Button Refresh (inactive when the zoom area
es ue 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 Button Event list... - 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.

64 Instructions for use PulmoVista 500 SW 1.2n


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 EELI trend view
and the Diagnostics view, the time scale also J C E
changes in the End-insp. trend view.
K L
EIT data N F M
G

531
 Touch the Refresh (L) button (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 is displayed as a
For information on the influencing factors, see
compressed waveform. The end-expiratory
page 131.
level at each cursor position is displayed as a
horizontal dashed line.

EELI trend C Regional impedance waveforms – up to


120 minutes of data is 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 values
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 chang- Value at C is less than the val-
es ue at Ref F Cursor button Ref
G Cursor button C
H Cursor position Ref
I Cursor position C

Instructions for use PulmoVista 500 SW 1.2n 65


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.
– MEDIBUSor MEDIBUS.X data, if MEDIBUS
or MEDIBUS.X is available as selected in 1 Touch the Time scale button (L).
System setup, see page 86
2 Select the time by turning the rotary knob and
– Date and time
press to confirm.
K MEDIBUSor MEDIBUS.X trend parameters, if
If the time scale is changed in the EELI trend view
MEDIBUS or MEDIBUS.X is available as
and the Diagnostics view, the time scale also
selected in System setup, see page 86
changes in the End-insp. trend view.
L Button Time scale (inactive when the zoom
area has been zoomed into)
Refreshing EIT data
M Button Refresh (inactive when the zoom area
 Touch the Refresh button (M) (inactive when
has been zoomed into)
the zoom area has been zoomed into).
N Button Event list... - 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 – the page 131.
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 EELI trend
view, the cursor is set to the same position in the
End-insp. trend view.

66 Instructions for use PulmoVista 500 SW 1.2n


Operation

Diagnostics A Global impedance waveform – up to 2 hours of


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

A B The Conduct analysis dialog window also


contains the Sections and RVD configuration
C pages.
D D
NOTE
E F G The previous analysis is deleted every time the
H section settings are changed.
557

Instructions for use PulmoVista 500 SW 1.2n 67


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 (A) page, the user can make the On the RVD (A) page, 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 cut-off value (E). All pixels with an
position, press the rotary knob or tap outside of RVD value greater than the set RVD cut-off
the waveform field. value are displayed in yellow.
– Manually add a section (C) – The new, light gray – Select the RVD parameter. Tap the RVD Ratio
section is added in the middle of the two sliders (F) or RVD SD (G) button. RVD Ratio, indicated
and can be moved to the desired position by as % of the total number of pixels of the
tapping the waveform field, dragging the section ventilated area, describes the ratio of the
across the screen, or by turning the rotary knob. number of pixels with an RVD above the RVD
To confirm the position, press the rotary knob or cut-off value to the total number of pixels. RVD
tap outside of the waveform field. SD, indicated as % of Ti, describes the standard
deviation of all RVD values of the ventilated
– Manually delete a section (D) – Tap the desired
area.
section. The section is highlighted in light gray.
Touch the Remove section button (D). Another If the calculation and display of the RVD parameter
section can be selected by turning the rotary is switched off, only the buttons (B) and (C) are
knob. Press the rotary knob to delete the active.
section.
The following relevant notes on using and
– Define spontaneous breaths per second (E). interpreting the RVD parameter must be observed:
– Define the reference section for the individual The Regional Ventilation Delay (RVD) is a
analysis (F). parameter which displays regional inspiration
delays in comparison with global inspiration and
Section can only be moved within the area defined
may indicate the cyclical collapse and re-opening of
by the sliders.
lung regions as well as display regionally varying
time constants. Varying time constants have a
particularly heavy impact on the display of the RVD
parameter during long inspiratory times, short
expiratory times and a quick rise in ventilation
pressure. A “long” ventilation phase can be
recognized based on the patient flow of 0 at its end.

68 Instructions for use PulmoVista 500 SW 1.2n


Operation

The influence of varying time constants can be Results of the analysis


largely suppressed through a slow pressure rise up
If the PEEP trial analysis or Customized analysis
to the end of the inspiration and a long expiratory
button is pressed, the Conduct analysis dialog
time.
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 which are imported
regional delay was detected, depending on the
via MEDIBUS or MEDIBUS.X are also
configuration, are displayed in yellow. Tapping a
displayed. Sections whose tidal images are
tidal image opens the RVD analysis dialog
displayed in the analysis are highlighted in light
window which displays an RVD image. The
gray. Sections which are not displayed are
RVD image displays an early inspiration
displayed 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
slider is not at the start or 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.

Instructions for use PulmoVista 500 SW 1.2n 69


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 CL LP [%] or CL [%] is displayed as:
Tapping a tidal image opens the Details dialog
– PEEP trial analysis: Compliance loss towards
window in which the tidal image is displayed in
lower PEEP levels (CL LP [%]) in white
a larger format and the progression of the
impedance waveform of a pixel is compared to – Customized analysis: Compliance loss (CL
the progression of the global impedance [%]) in orange
waveform.
H Diagram with the numeric values of all sections
D Display of the RVD parameter – Depending on depending on the settings and analysis type.
the configuration, as the standard deviation of
I Scroll buttons for shifting the displayed images
the RVD (RVD SD) for every section or as the
– only active if more than 5 sections are
RVD Ratio. RVD SD, indicated as % of Ti,
defined.
describes how inhomogeneous the regional
inspiration within the contour of the ventilated J Event list...
area is. RVD Ratio, indicated as % of the total
K Help...
number of pixels, describes the ratio of the
pixels with RVD to the total number of pixels L Conduct analysis...
within the contour of the ventilated area.
M Capture analysis – The currently displayed
E PEEP trial analysis: Images of the analysis is saved as a screenshot.
Compliance loss for every displayed section.
N Review analysis... – only active if at least one
The pixel compliance loss is calculated in
analysis is saved. Saved analyses can be
relation to the maximum compliance which is
opened and viewed in a separate dialog
ascertained within all sections.If there is a
window.
compliance loss towards higher PEEP levels
(CL HP [%]), the loss is displayed in orange. If O Create report – only active if a USB mass
there is a compliance loss towards lower PEEP storage device with sufficient storage space is
levels (CL LP [%]), the loss is displayed in connected to the cockpit. An image file is
white. The regions without a compliance loss created containing the entered parameters, the
are displayed in dark gray. event list, all available analysis parameters and
Customized analysis: Images of the MEDIBUS values, and a screenshot of the
compliance changes in comparison to the analysis. Furthermore, an editable text file with
selected reference section for every displayed the same information but without the
section, referred to as a compliance win (CW screenshot is created. Reports can also be
[%]) and Compliance loss (CL [%]). The created based on previously saved analyses.
regions with compliance win are displayed in To do this, the saved analysis must be selected
cyan and the areas with compliance loss in with the Review analysis... button, followed by
orange. tapping the Create report button.
F In addition to the images, the sum of the values
for CL HP [%] or CW [%] is displayed as
follows:
– PEEP trial analysis: Compliance loss towards
higher PEEP levels (CL HP [%]) in orange
– Customized analysis: Compliance win (CW
[%], Compliance win towards lower PEEP
levels) in cyan

70 Instructions for use PulmoVista 500 SW 1.2n


Operation

Freeze display

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

Export screenshot

This function is only available if a USB storage


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

Instructions for use PulmoVista 500 SW 1.2n 71


Operation

Marking events

The user can mark events during measurement. An The Mark event page displays the following:
event is marked with the time when the button was
A Event number
pressed. Events are flagged with a number which is
automatically incremented. The events can be B Event time
annotated. All events which are entered during the
C Input line or comment of last event, where
entire measuring time frame, can be viewed on the
applicable
Event list page.
D Clear button
 Touch the Mark event... button in the main
menu bar. E Enter button

Mark event
A B Adding comments to an event
1 Enter the required comments using the on-
C D screen keyboard. A maximum of 30 characters
can be entered. The inserted text is displayed in
the input line (C).
E 2 Confirm with the Enter button (F) or by pressing
the rotary knob.
544

Clearing comments
 Touch the Clear button (D).

Signal quality

Signal quality indicator


High Medium Low
PulmoVista 500 continuously determines the global
signal quality of the measured data. The signal
quality is displayed in the header bar as a bar
graph.
535

When the signal quality is classified as Low,


impedance waveforms in the End-insp. trend
view, EELI trend view, and the Diagnostics
view are displayed in darker gray color.

72 Instructions for use PulmoVista 500 SW 1.2n


Operation

When one of the following messages is displayed, The Signal check page is a graphical
the signal quality is Low: representation of electrode location and resistance
– Safety function activated - Technical at each of the 16 electrodes, as well as at the
– Safety function activated - Temperature reference electrode. Electrode resistance is
– Restart calibration continuously monitored. The bargraph is updated
– Electromagnetic disturbance dynamically.
– Check patient cable connection
 Touch the Signal check... button in the main
– Check electrode contact
menu bar.
See "Problem solving" on page 97.
Signal check
The signal quality is an indicator for the reliability of
the EIT data. In principle, always try to achieve a A
high signal quality. A medium quality or, in rare 16 1
15 2
cases, also a low quality may be tolerated to obtain 14 3

useful information from PulmoVista 500. This 13 4

depends on: 12 5

– the experience of the user 11


10 7
6

– additionally available clinical information 9 8

– the possible contribution of EIT data to


therapeutic decisions B
600
Even when the signal quality is high, artifacts 500
cannot be completely excluded, see "General
400
considerations" on page 131.
300 D
Touching one of the following messages in the
header bar will cause the Signal check dialog to 200 C
open: 100

– Restart calibration 0
– Check electrode contact 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 R

– Check reference electrode


– Unstable electrode contact E
– 15-electrode mode

534
– Low signal quality
The Signal check page displays the following:
A Electrode position
Signal check
B Resistance of each electrode

NOTE C Resistance of reference electrode


The electrode resistance depends on various con- D Defined limit of resistance
ditions which may not be related to the information
displayed by PulmoVista 500. For this reason, the E Start button to restart calibration
determination of such resistances is not defined as
a measuring function in the sense of the
Directive 93/42/EEC concerning Medical Devices.

Instructions for use PulmoVista 500 SW 1.2n 73


Operation

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 sig-
nal quality may be impaired
Red Skin-electrode contact is insufficient
for measurement to proceed

If the resistance exceeds the defined limit of 300 


for the EIT electrodes and 400  for the reference
electrode, the bargraph representing the affected
electrode is displayed in red. The message Check
electrode contact or Check reference electrode
is concurrently displayed.
PulmoVista 500 has been optimized for electrode
resistances of 30 to 200 Ohm and a reference
electrode resistance of 30 to 400 Ohm. Outside of
this range the signal quality may be reduced.

Restarting calibration
Prerequisite: PulmoVista 500 is not in standby
mode.
When the message Restart calibration is
displayed, calibration is recommended.
 Touch the Start button (E).
The following functions are not available during
calibration:
– Record
– Mark event
– Reference

74 Instructions for use PulmoVista 500 SW 1.2n


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 (B) button on the
waveforms Start/Standby (A) page.
– EITsettings
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

Instructions for use PulmoVista 500 SW 1.2n 75


Operation

Additional functions provided by the option ADAP

The ADAP option 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 is
recorded, the patient ID forms part of the file name.
 Entering patient data, see "Patient data" Data review
on page 94.
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.
Recording can be done in a single mode or in a
continuous mode. To select the Record mode, see Data review H
"Configuring data recording" on page 94. MO Q S
When the device is not connected to mains power I
supply, the recording of data is limited by the level K
of available battery charge. A 1
T N R
Lack of available disk memory can limit recording of
J
K
data, see "Free disk space (J)" on page 96. N R
B
J
K
Starting a recording N R
 Touch the Record button in the main menu bar. D C J K
The progress of the recording is displayed in the E N R
J
header bar (A). F W K
G L U
V
540

A The Data review page displays the following:


503

A Dynamic image – shows impedance changes in


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

76 Instructions for use PulmoVista 500 SW 1.2n


Operation

B Status image – as selected in the display L 5 navigation buttons:


settings on the Data review page – Previous page , opens the previous
– Tidal image: Differential image of the end of page of the EIT data file
inspiration compared to the beginning of – Play – moves the cursor through the
inspiration, which represents regional current page of the EIT data file. In Standby
distribution of impedance changes of the mode the cursor speed is increased with
last detected breath. repeated pressing.
– Minute image: Tidal images averaged over Depending on the selected cursor speed the
the last minute or less, when the cursor is recorded EIT data files may replay faster or
located within the first minute of the EIT data slower than real-time data
file. – Pause – pauses the cursor at its current
location. Play can be resumed by pressing
C Set ROI... – to set the ROI, see "Setting ROIs"
the Pause button a second time.
on page 79
– Stop – stops the play function and returns
D File... – to select a file, see page 78 the cursor to the beginning of the current
page
E Patient data... – displays patient data
– Next page , opens the next page of the
associated with the opened file, see page 78
EIT data file
F Display... – to change the display settings,
M Global tidal variation TV global or global minute
see page 79
tidal variation MTV global – depending on the
G MEDIBUS data... – displays the MEDIBUS or selected status image, expressed as the sum of
MEDIBUS.X parameters at the cursor position if all regional relative impedance changes of the
the selected file contains MEDIBUS or entire status image (dimensionless)
MEDIBUS.X data. One MEDIBUS or
N Regional tidal variation or minute tidal variation
MEDIBUS.X parameter can be selected that is
– depending on the selected status image,
superimposed on the global impedance
expressed as the sum of regional relative
waveform, see page 79.
impedance changes within the defined ROI
H File name of the selected EIT data file and (dimensionless)
name from associated patient data, or
O Global tidal variation TV global or global minute
additional help text
tidal variation MTV global – depending on the
I Global impedance waveform – displays the selected status image, always expressed as
relative impedance changes 100 %
J Regional impedance waveforms – represent P Regional tidal variation or minute tidal variation
relative impedance changes of the defined ROI – depending on the selected status image of the
defined ROI, expressed as percentage
K Cursor
Q Global relative impedance change (compared
to the baseline level) at the cursor position,
expressed as the sum of all regional relative
impedance changes within the entire displayed
dynamic image (dimensionless)

Instructions for use PulmoVista 500 SW 1.2n 77


Operation

R Regional relative impedance change at the 3 Touch the button (B) to open the list of all
cursor position, expressed as the sum of available subfolders. Select the subfolder using
regional relative impedance changes within the the touchscreen or the rotary knob.
part of the displayed dynamic image
4 Touch the button (C) to open the list of all
(dimensionless) that corresponds to the defined
available files. Select the file using the
ROI within the status image
touchscreen or the rotary knob.
S MEDIBUS or MEDIBUS.X parameter
(displayed in green), if selected on the
Displaying patient data
MEDIBUS data page
Patient data is displayed on the Patient data page.
T Event marker
Prerequisite: The Data review page is open.
U Indicator for the signal quality of the selected
EIT data file  Touch the Patient data... button.
V Event comment
Patient data
W Button Auto rescale D
E
Selecting the file
F
All recorded EIT data are stored on the hard disk of G
the Cockpit in the following file structure:
– Folder H
– Subfolder
– File
Prerequisite: The Data review page is open.
1 Touch the File... button.

542
File The following patient data are displayed:
A – Name (D)
– Age/Date of birth (E)
– Patient ID (F)
– Short comment (G)
B – Notes (H)
Patient data are entered and edited from System
setup > Data recording > Patient data. Once
C patient data has been recorded as part of an EIT
data file, it cannot be edited.
If no patient data are entered, see page 95.
541

2 Touch the button (A) to open the list of all


available folders. Select the folder using the
touchscreen or the rotary knob.

78 Instructions for use PulmoVista 500 SW 1.2n


Operation

Changing display settings Displaying MEDIBUS or MEDIBUS.X data


Initial display settings on the Data review page are MEDIBUS or MEDIBUS.X data are displayed on
the same as display settings in the Main view. Once the MEDIBUS data page.
display settings on the Data review page are
Prerequisite: The Data review page is open.
changed, they persist until the device is switched
off. 1 Touch the MEDIBUS data... button.
Display settings made on the Data review page do
not affect Main view settings. MEDIBUS data
Prerequisite: The Data review page is open.
B
1 Touch the Display... button.

Display
A
A
B

547
All MEDIBUS or MEDIBUS.X parameters at the
C cursor position are displayed in the list (A) on the
MEDIBUS data page if the selected file contains
D MEDIBUS or MEDIBUS.X data.
E 2 Touch the button (B) to open the list of all
available MEDIBUS or MEDIBUS.X
F parameters. Select the parameter to be
543

superimposed on the global impedance


The following display settings can be set: waveform using the touchscreen or the rotary
– Filter (A) knob.
– Cut-off freq. [/min] (B)
– Artifact filter (C)
– Status image (D) Setting ROIs
– Display thoracic contour (E) The initial ROI settings are the same on the Data
– Time scale (F) review page and in the Main view. Once ROI
2 Set the display settings in the same manner as settings on the Data review page are changed,
in System Setup, see "Configuring the screen they persist until the device is switched off.
layout" on page 82. ROI settings on the Data review page do not affect
Main view settings.
 Set the ROIs in the same manner as in the Main
view, see page 59.
When ROIs are set to Layers or Quadrants, the
central positon of all the ROIs is indicated by "x" "y"
value. When the ROIs are set to Free, the central
position of each ROI is indicated.

Instructions for use PulmoVista 500 SW 1.2n 79


Operation

Ending operation

Switching off the system NOTE


A device shut-down can be forced by pressing the
NOTE On/Off switch (A) for 4 seconds. This may result in
In the case of voltage peaks in the mains power data loss. This type of shut-down should therefore
supply, it may not be possible to switch off the de- only be used if a normal shut-down is not possible.
vice. Contact DrägerService .

1 PulmoVista 500 to standby mode: Touch the Removing the patient interface
Start/ Standby... button in the main menu bar.
Touch the Standby button on the Prerequisite: PulmoVista 500 is switched off.
Start/Standby page.
1 Remove the patient cable plugs from the patient
cable ports on the trunk cable.
Infinity C500 (MS18746)
2 Remove the reference electrode snap from the
reference electrode.
A 3 Remove the closure snap from the closure stud.
4 Open the electrode belt.

Infinity C500 (MK31500) 5 Lift the patient and remove the electrode belt
from under the patient. Make sure that the
electrode belt does not snap back towards the
patient. Ensure that the patient is lifted clear of
A the electrode belt so that no skin damage can
occur when removing the electrode belt.
018

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

Disconnecting PulmoVista 500 from a


Dräger device
529

The OK button (B) is preselected. When the transfer of MEDIBUS or MEDIBUS.X


data is no longer required, the MEDIBUS cable
3 Confirm with the rotary knob. must be removed from PulmoVista 500 and the
Dräger device in use.
Canceling the Shut down  To remove the MEDIBUS cable, see page 42.
 Touch the Cancel button (C).

80 Instructions for use PulmoVista 500 SW 1.2n


Configuration

Configuration

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Configuring the screen layout. . . . . . . . . . . . 82


Configuring the display . . . . . . . . . . . . . . . . . . . 82
Configuring the data import . . . . . . . . . . . . . . . 86

Configuring EIT settings . . . . . . . . . . . . . . . . 88


Frame rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Operating frequency . . . . . . . . . . . . . . . . . . . . . 89

Configuring the system . . . . . . . . . . . . . . . . . 90


Selecting country-specific settings . . . . . . . . . . 90
Service pages. . . . . . . . . . . . . . . . . . . . . . . . . . 91
Simulating patient data . . . . . . . . . . . . . . . . . . . 93

Configuring data recording . . . . . . . . . . . . . . 94


Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
File handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Instructions for use PulmoVista 500 SW 1.2n 81


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 password-protected.

Configuring the screen layout

The Screen layout page consists of the Display System setup


and Data import subpages.

A
Configuring the display
C L M N
1 Touch the System setup... button in the main
menu bar to open the Screen layout page (A).
D O P B
2 Select the Display (B) tab.
Q

E
F R S
G T U
H
I

J V
K W X
507

82 Instructions for use PulmoVista 500 SW 1.2n


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 Dynamic image (T), Status image (U)
(H) Display thoracic contour On, Off
(I) Display contour of ventilated On, Off
area
(J) Time scale Displayed duration of the impedance waveform
(V)
(K) Baseline update Breath (W), Time scale (X)

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 Principles of operation


(/min)
Off (I) – Impedance changes of all frequen-
cies are displayed.
Signals from high-frequency noise
may be included.

Instructions for use PulmoVista 500 SW 1.2n 83


Configuration

Filter setting Cut-off frequency setting Principles of operation


(/min)
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
played when band pass filtering frequency: heart rate less 10,
changes are attenuated.
is activated. upper frequency: Heart rate
plus 10

84 Instructions for use PulmoVista 500 SW 1.2n


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 In the Diagnostics view, the contour surrounds in
all displayed images the area that was at least
If Full-screen image has been selected, the
temporarily ventilated during the selected sections.
selected image is shown full screen. The other
image is shown smaller.
 Touch the Dynamic image (T) or Status image
button (U).

Instructions for use PulmoVista 500 SW 1.2n 85


Configuration

Setting the time scale System setup


The time scale setting determines the duration of
the impedance waveforms in the Main view and the A
Full-screen image view.
1 Touch the button (V) in the rowTime scale (J). C
2 Select the value by turning the rotary knob and D
press to confirm.
E F B
The available time scale settings vary with the F
selected frame rate.
F
Baseline update H I
G
The baseline update setting defines at which
interval the baseline of the impedance waveforms
is updated. J K
 Touch the Breath button (W) to update the
K
baseline after each detected breath. K
 Touch the Time scale (X) button to update the

508
baseline each time the cursor passes the zero
PulmoVista 500 displays the MEDIBUS or
position of the time scale.
MEDIBUS.X settings (C) of PulmoVista 500 and
For more details, see "Definition of baseline the model of the connected Dräger device (D).
frames" on page 142.
On the Data import page, the user can change the
following settings:
– Imported waveforms (E)
Configuring the data import – Volume waveform (G)
– Trend display (J)
MEDIBUS or MEDIBUS.X settings for COM 1 are
fixed on PulmoVista 500 and must be adjusted on
the connected Dräger device. To connect the Imported waveforms
Dräger device, see "Preparation for using the To select which MEDIBUS or MEDIBUS.X
MEDIBUS or MEDIBUS.X protocol" on page 42. waveforms are stored with EIT data, proceed as
Use the values below to configure the COM follows:
settings on the Dräger device according to its
instructions for use. 1 Touch the button (F) to open the parameter
selection list.
Baud rate 19200 2 Select a parameter.
Parity none
Stop bit 1

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


menu bar to open the Screen layout page (A).
2 Select the Data import (B) tab.

86 Instructions for use PulmoVista 500 SW 1.2n


Configuration

Volume waveform
Used to determine if the imported volume
waveform is superimposed on the global
impedance waveform.
Prerequisite: "Volume waveform" is selected in the
Imported waveforms (E) field.
 Touch the On (H) or Off button (I).
A transmission delay of MEDIBUS or MEDIBUS.X
data may cause a phase shift between the volume
and the impedance waveforms. Filtering causes a
delay of the impedance waveforms, which may
affect the phase shift.

Trend display
This setting defines which three MEDIBUS or
MEDIBUS.X parameters are displayed as part of
trend data. If available, all MEDIBUS- or
MEDIBUS.X parameters are stored during
recording, regardless of the displayed parameter.
This setting applies to the End-insp. trend and
EELI trend views.
1 Touch the button (K) to open the parameter
selection list.
2 Select a parameter.

Instructions for use PulmoVista 500 SW 1.2n 87


Configuration

Configuring EIT settings

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


menu bar.
2 Touch the EIT settings tab (A). 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)

88 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 89


Configuration

Configuring the system

The System page consists of the following Language


subpages:
Prerequisite: PulmoVista 500 is in standby mode.
– Country
– Service 1 Touch the button (F) to open the language
– Simulation selection.
2 Select the country-specific language.
Selecting country-specific settings
Date and time
1 Touch the System setup... button in the main Prerequisite: PulmoVista 500 is in standby mode.
menu bar.
PulmoVista 500 displays the current date and time
2 Touch the System tab (A). in the Date and time (D) lines.
3 Touch the Country tab (B). 1 Touch the relevant buttons for year, month, day,
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
G  Touch the mbar (H) or cmH2O (I) button.

E H I
514

On the Country page, the user can change the


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

90 Instructions for use PulmoVista 500 SW 1.2n


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

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

A Filter Off
Status image Tidal image
Full-screen image Status image
Display of thoracic contour On
C Time scale 30 s
B
Frame rate 20 Hz
Adjustment of operating Automatic
frequency
Record mode Continuous
D
File length for recording 30 s
Saved MEDIBUS or Paw, Flow, Vol.
MEDIBUS.X waveforms
MEDIBUS or MEDIBUS.X Off
volume waveform super-
imposed on the global im-
E pedance waveform
515

MEDIBUS or MEDIBUS.X PEEP


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

Instructions for use PulmoVista 500 SW 1.2n 91


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 tab (H).
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).
545

Installing applications
The Service dialog window consists of the
Only use SIM cards and USB-SIM card readers
following pages:
supplied by Dräger.
– System information (F)
– Product specific (G) 1 Insert the SIM card into the USB SIM card
– Applications (H) reader.
Page System information 2 Insert the USB SIM card reader into the USB
port on the Cockpit.
The System information page is preselected and
contains information about the software versions of 3 Touch the Install button (K).
the installed system components (I).
4 Select the application from the list (J) using the
Page Product specific rotary knob and press to confirm. If only one
application is available, there is no need to
This page is password-protected.
select the application.
Prerequisite: The Service page is open.
1 Touch the Product specific tab (G).
2 Enter the password.

92 Instructions for use PulmoVista 500 SW 1.2n


Configuration

5 To assure correct installation of the application,


wait at least 20 seconds before removing the
USB SIM card reader.
6 If applicable, install further applications (repeat
steps 3, 4, and 5).
7 When all applications are installed, restart the
device.
The installed application is displayed in the list (L).

Simulating patient data

In the simulation mode, previously recorded patient System setup


data can be displayed in all views. The simulation
mode can be used for demonstration purposes. If
patient data are changed in the simulation mode, A
e.g., for demonstration purposes, these changes
will not affect recorded data.
Prerequisite: PulmoVista 500 is in standby mode. C D
1 Touch the System setup... button in the main
menu bar.
2 Touch the System tab (A). E B
3 Touch the Simulation tab (B).

H
553

Instructions for use PulmoVista 500 SW 1.2n 93


Configuration

To activate simulation mode, proceed as follows: 2 Touch the On button (C) and press the rotary
knob to confirm.
1 Touch the relevant buttons (E), (F), (G), or
In the header, Simulation is displayed.
(H) to open the list of available folders,
subfolders, and files. Select a folder, a To stop the simulation mode, proceed as follows:
subfolder, and the EIT data files that are
1 Touch the Start/ Standby... button in the main
intended to be used for the simulation.
menu bar. Touch the Standby button on the
Selecting folders and subfolders requires the Start/Standby page.
option ADAP.
2 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
3 Touch the System tab (A).
(F) buttons are inactive. A preinstalled example
EIT data file for demonstration purposes can be 4 Touch the Simulation tab (B).
selected using the button (G).
5 Touch the Off button (D).

Configuring data recording

Data recording requires the option ADAP. System setup


The Data recording page consists of the Patient
data and File handling subpages.
A

Patient data C H
D H B
1 Touch the System setup... button in the main
menu bar. E H
2 Touch the Data recording tab (A). F H
3 Touch the Patient data tab (B). G H
I

K M N
L
516

94 Instructions for use PulmoVista 500 SW 1.2n


Configuration

On the Patient data page, the user can change the When data is recorded, file names are
following data and settings: automatically created using the following format:
– Name (C) – Folder: current date
– Age/Date of birth (D) – Subfolder: Patient ID_Short comment
– Patient ID (E) – File: Patient ID_Short comment_Incremental
– Short comment (F) counter
– Notes (G)
The directory and the file name are displayed in the
– Record mode (K)
(I) field. If either the patient ID or short comment is
– File length (L)
changed, a new subfolder and a new file name is
created after the first recording.
Entering or editing patient data
If no Patient ID or no Short comment is entered,
 Touch the Edit button (H) next to the field to be the subfolder and the file name are both
edited to display the on-screen keyboard. Enter automatically labeled ID_SC.
the patient data (up to 20 characters for each
The incremental counter depends on the record
field, up to 50 characters for the Notes field).
mode.

Record mode File name Principles of operation


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

Clearing data NOTE


 Touch the Clear data button (J) to clear the text A continuous recording is automatically ended
fields. after 24 hours.

 Touch the Single (M) or Cont. button (N).


Data recording settings
The record mode and the file length can be File length
adjusted.
1 Touch the File length button (L).
The record mode can be set as follows:
– Single – Single file mode to record a single file 2 Select the value by turning the rotary knob and
of a selected file length when the Record button press to confirm.
in the main menu bar is touched. Be aware that the time taken to open files increases
– Cont. – Continuous mode to record multiple with the size of the file.
continuous files of a selected file length as long
as the Record button in the main menu bar is
active.

Instructions for use PulmoVista 500 SW 1.2n 95


Configuration

File handling – Properties of the folder, subfolder, or file (F)


– Size of the file
All recorded EIT data are stored on the hard disk of – Number of the contained subfolders or files
the Cockpit in the following file structure: – Date of the file record
– Folder – Button to open the list of all folders,
– Subfolder subfolders, or files (G)
– File – Button Copy to USB (H)
– Button Delete (I)
Folders, subfolders, and files can be deleted or
copied to a connected USB storage medium.
Deleting a folder, subfolder, or file
Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the relevant button (G) to open the list
of all available folders, subfolders, or files.
Accessing the File handling page Select a folder or subfolder or a single file.
1 Touch the System setup... button in the main 2 Touch the relevant Delete button (I) and confirm
menu bar. by pressing the rotary knob.
2 Touch the Data recording (A) tab.
3 Touch the File handling (B) tab. Copying a folder, subfolder, or file
1 Connect a USB storage medium to the left or
System setup
right USB port on the Cockpit.
2 Touch the relevant button (G) to open the list
A of all available folders, subfolders, or files.
Select a folder or subfolder or a single file.
G
C H 3 Touch the relevant Copy to USB button (H) and
F I confirm by pressing the rotary knob.

G B
Free disk space (J)
D H
I A portion of the hard disk drive is reserved for EIT
F
data. This parameter indicates the available space
G in this reserved section.
E H
F I Free USB space (K)
This parameter indicates the available space on the
J connected USB storage medium.
K
After data export to USB storage medium
517

The File handling page contains the following: Wait until message "Copied files: X" is shown
– Folder (C) before removing the USB storage medium.
– Subfolder (D)
– File (E)

96 Instructions for use PulmoVista 500 SW 1.2n


Problem solving

Problem solving

Message – Cause – Remedy . . . . . . . . . . . . . 98

Instructions for use PulmoVista 500 SW 1.2n 97


Problem solving

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.

Priority Message 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 contact.
After improving electrode con-
tact, touch the "Start" button.
Restore electrode contact or
decrease electrode resistance
as described in these instruc-
tions for use.

98 Instructions for use PulmoVista 500 SW 1.2n


Problem solving

Priority Message 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 securely at-
tached 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 condition
persists, perform the device
check. If the device check pass-
es, replace the patient cable. If
the device check fails, replace
the trunk cable. If the condition
persists, call DrägerService.
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 1.2n 99


Problem solving

Priority Message 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 ap-
plied to the patient.
Check if the reference electrode
has good contact with the skin.
Press the reference electrode
gently against the skin.
Restart the measurement. If the
condition persists, replace the
reference electrode. If the con-
dition persists, call DrägerSer-
vice.
200 Device failure Internal communication fail- Restart the device. If the mes-
ure. Cockpit or EIT module sage appears again, call
is faulty. Electrocautery or DrägerService.
electrosurgery also may
cause this message.
040 Electrode belt not detect- The closure snap on the pa- Connect the closure snap of the
ed tient cable was not connect- patient cable to the closure stud
ed correctly after the elec- on the electrode belt after the
trode belt was closed. electrode belt is closed.
105 Electromagnetic distur- Electromagnetic distur- Investigate which devices in the
bance bances have been detected 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 Instructions for use PulmoVista 500 SW 1.2n


Problem solving

Priority Message Cause Remedy


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 gradu-
ally.
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.
050 Patient cable not detect- The patient cable is not con- Connect the patient cable to the
ed nected to the trunk cable. trunk cable before starting the
measurement. If the condition
The patient cable is faulty.
persists, replace the patient ca-
ble.
130 Patient cable or trunk ca- The patient cable or the Perform the 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.

Instructions for use PulmoVista 500 SW 1.2n 101


Problem solving

Priority Message Cause Remedy


080 Period of use of elec- The recommended period If signal quality during EIT mea-
trode 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 ca-
nectors. The device is ble plugs from the test connec-
ready to start the device tors.
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 sig-
body position. nals, electrocautery, or electro-
surgery, no remedy is required.
Pacemaker signals, electro-
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.
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 mes-
sage 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.

102 Instructions for use PulmoVista 500 SW 1.2n


Problem solving

Priority Message Cause Remedy


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 with
trode is too high. poor contact. Use the "Signal
check" dialog window to evalu-
ate the effectiveness of adjust-
ments.
Restart the measurement. If the
condition persists, replace the
electrode belt and restart the
measurement. If the condition
persists, replace the patient ca-
ble and restart the measure-
ment.
Restart the measurement. If the
condition persists, replace the
electrode belt. If the condition
persists, replace the patient ca-
ble. If the condition persists, 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 1.2n 103


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104 Instructions for use PulmoVista 500 SW 1.2n


Cleaning and disinfection

Cleaning and disinfection

Safety information for reprocessing. . . . . . . 106


Classification of medical devices . . . . . . . . . . . 107
Classification of device-specific components . . 107

Reprocessing procedure . . . . . . . . . . . . . . . . 108


Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Manual cleaning . . . . . . . . . . . . . . . . . . . . . . . . 108
Disinfecting the patient interface . . . . . . . . . . . 109
Disinfecting surfaces . . . . . . . . . . . . . . . . . . . . 109
Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . 109

Before reusing on patient . . . . . . . . . . . . . . . 109

Instructions for use PulmoVista 500 SW 1.2n 105


Cleaning and disinfection

Safety information for reprocessing

WARNING WARNING
Risk of infection Risk of electric shock and of device malfunc-
tion
Reusable products must be reprocessed to
prevent increased risk of infection and impair- Penetrating liquid may cause malfunction of
ment of their operation. or damage to the device, which may endanger
– Observe the hygiene regulations of the the patient.
hospital.
Do not immerse or rinse the EIT system or its
– Perform the reprocessing using a validat- components (e.g., patient interface, Cockpit,
ed method. cables, USB storage media) in liquids. During
– Reprocess reusable products after every surface disinfection make sure that no liquids
use. enter the device.
– Observe the manufacturer specification
for cleaning agents and disinfectants. If a liquid is accidentally spilled on the device,
disconnect the device from the power source.
Contact service personnel regarding the con-
WARNING
tinued safety of the device before putting it
Risk of electric shock back into operation.
Do not sterilize PulmoVista 500 and its acces-
sories as this may damage the insulation of WARNING
cables. Instead, perform the cleaning proce- Do not use sharp tools or abrasives. Do not
dures described in the instructions for use. immerse electrical connectors in water or oth-
er liquids. Avoid the accumulation of liquid at
WARNING the edge of the screen as this may damage the
Risk of electric shock device.

Do not disconnect the system cables. If nec-


CAUTION
essary, contact service personnel.
Do not clean the Cockpit using an alcoholic solu-
tion. Such solutions may damage the Cockpit.

CAUTION
Risk of damage to the touchscreen
Do not spray the cleaning liquid directly on the
touch screen. The cleaning liquid must be applied
to a cloth or tissue before cleaning the surface.

106 Instructions for use PulmoVista 500 SW 1.2n


Cleaning and disinfection

CAUTION – Safe handling of substances


– Precautionary measures when using
Risk due to faulty products
substances
Signs of wear can occur in reusable products,
More information on these aspects can be found in
e.g., cracks, deformation, discoloring, or peeling.
the manufacturer specifications for the respective
Check the products for signs of wear and replace cleaning agent or disinfectant.
them if necessary.
When using flammable substances for disinfection,
make sure that the room is sufficiently ventilated.
NOTE
Do not clean the touch screen of the Cockpit while When used in the intended manner there is no limit
monitoring a patient. Before cleaning, take the de- to the number of times the electrode belt, the
vice out of operation. patient cable and the trunk cable may be
reprocessed within the recommended lifetime.
Dräger cannot provide any assurances as to the
effectiveness of non-validated cleaning agents,
disinfectants, and methods. Dräger on principle
does not provide any assurances regarding the
following points:
– Capability of substances to prevent infection
– Environmental compatibility of substances

Classification of medical devices

Medical devices and their components are


classified according to the way they are used and
the resulting risk.

Classification Definition
Non-critical Components that come into contact with intact skin only
Semi-critical Components that carry breathing gas or come into contact with mucous mem-
branes or pathologically altered skin
Semi-critical A No special requirements for reprocessing
Semi-critical B Increased requirements for reprocessing
Critical Components that penetrate the skin or mucous membranes or come into con-
tact with blood

Classification of device-specific components

This medical device and all its components have


been classified as non-critical.

Instructions for use PulmoVista 500 SW 1.2n 107


Cleaning and disinfection

Reprocessing procedure

Prerequisite: The patient interface is disassembled, Manual cleaning


see "Removing the patient interface" on page 80.
1 Wipe all foreign material off the surface of the
patient interface, using a disinfectant soaked
Disinfectants cloth:
– Patient cable
– Electrode belt
Information on disinfectants
– Trunk cable
Use disinfectants that have been approved for the
2 Wipe all foreign material off the surface of the
relevant country and are suitable for the respective
following parts, using a damp cloth:
reprocessing methods.
– Cockpit
Compounds using the following agents may cause – EIT module
material damage and must not be used, unless – Power supply module
specifically recommended by Dräger, on any part of – Trolley
the device or accessories:
3 Do not scrape off foreign material which is stuck
– Halogen-releasing compounds
to the surface, but soften with a damp cloth and
– Strong organic acids
then wipe off.
– Oxygen-releasing compounds
4 Wipe until all foreign material is visibly removed
It is the responsibility of the user to observe national
and allow to dry completely. Carefully dry the
and hospital-specific guidelines as well as all
Cockpit surfaces with a lint-free cloth.
guidelines issued by relevant regulatory authorities.
Always observe the instructions provided by the 5 Check that all visible soiling has been removed.
manufacturer of the disinfectant. If necessary, repeat manual cleaning until
visible soiling is removed.
The effectiveness of the selected disinfectant must
be proven by the manufacturer of the disinfectant. In cases of major contamination of the trunk cable,
The following disinfectants have been tested by electrode belt or patient cable with potentially
Dräger and shown to have good effectiveness and infectious material, e.g., after soaking in body fluids
material compatibility at the time of the test: such as blood, vomit or urine, it is the responsibility
of the user to select the appropriate method of
Surface disinfectant for device surfaces
cleaning and disinfecting. Dräger recommends the
– Buraton 10F (Schülke+)
disposal of the infected part.
Surface disinfectant for patient interface
– Mikrobac Tissues (BODE Chemie)
The composition of the disinfectants is the
responsibility of the manufacturer and can change
over time.

108 Instructions for use PulmoVista 500 SW 1.2n


Cleaning and disinfection

Disinfecting the patient interface Disinfecting surfaces

The following components of the patient interface The following device surfaces can be disinfected:
can be disinfected: – Cockpit
– Trunk cable – EIT module
– Electrode belt – Power supply module
– Patient cable – Trolley
1 After manual cleaning disinfect the patient 1 After manual cleaning, disinfect surfaces by
interface by wiping with a cloth soaked in wiping with a cloth soaked in disinfectant.
disinfectant.
2 Remove disinfectant residues with a clean dry
 Observe the instructions provided by the cloth.
manufacturer of the disinfectant.
2 Re-wipe with a cloth soaked in water which has
at least drinking-water quality. Visual inspection
3 Remove disinfectant residues with a clean dry  Inspect all parts for damage and wear, e.g.,
cloth. formation of cracks, embrittlement or major
4 Inspect parts for visible damage. hardening, and residual soiling.

Before reusing on patient

1 Make sure that the device is connected to the


mains power supply, see "Connecting the
mains power supply" on page 39.
2 Confirm readiness for operation, see "Device
check" on page 47.
3 Attach patient interface, see "Attaching the
patient interface" on page 49.

Instructions for use PulmoVista 500 SW 1.2n 109


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110 Instructions for use PulmoVista 500 SW 1.2n


Service

Service

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Definition of maintenance concepts . . . . . . . . . 113

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Preventive maintenance . . . . . . . . . . . . . . . . 114

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Instructions for use PulmoVista 500 SW 1.2n 111


Service

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

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

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.

112 Instructions for use PulmoVista 500 SW 1.2n


Service

Definition of maintenance concepts

Concept Definition
Maintenance 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
Preventive 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.

Checks Interval Personnel responsible


Inspection Every 2 years Experts
Check the electrical safety in accor- Every 2 years Experts
dance with IEC 62353
Check that the multiplexer test is oper- Every 2 years Experts
ating correctly
Check that the trolley and castors are Every 2 years Experts
in sound condition and are operating
correctly
Check that the device, its components, Every 2 years Experts
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 Experts
the Cockpit and at the power supply
module are operating correctly
Check that the touchscreen is operat- Every 2 years Experts
ing correctly

Instructions for use PulmoVista 500 SW 1.2n 113


Service

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 Personnel responsible


Internal battery Every 2 years Replace Experts
(Infinity P2500)

Repair

Dräger recommends that all repairs are performed


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

114 Instructions for use PulmoVista 500 SW 1.2n


Disposal

Disposal

Disposing of the medical device. . . . . . . . . . 116

Disposing of batteries . . . . . . . . . . . . . . . . . . 116

Instructions for use PulmoVista 500 SW 1.2n 115


Disposal

Disposing 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 EU find the relevant information. If access to Dräger's
Directive 2002/96/EC website is not possible, contact your 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

Disposing of batteries

WARNING
Risk of explosion and of chemical burns
Improper handling of batteries can result in
explosions and chemical burns.
Do not throw batteries into fire. Do not force
batteries open.

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 experts prior
to disposing of the device. For countries outside of
the Federal Republic of Germany, observe the
applicable national laws and regulations for battery
disposal.

116 Instructions for use PulmoVista 500 SW 1.2n


Technical data

Technical data

Ambient conditions . . . . . . . . . . . . . . . . . . . . 118

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Performance characteristics . . . . . . . . . . . . . 118

Operating data . . . . . . . . . . . . . . . . . . . . . . . . 119

Classification . . . . . . . . . . . . . . . . . . . . . . . . . 120

Communication interfaces on Medical


Cockpit Infinity C500 . . . . . . . . . . . . . . . . . . . 121

Device combinations . . . . . . . . . . . . . . . . . . . 121

EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 121


General information . . . . . . . . . . . . . . . . . . . . . 121
Electromagnetic environment . . . . . . . . . . . . . . 122
Recommended separation distances from
wireless communication devices . . . . . . . . . . . 123

Connections to IT networks . . . . . . . . . . . . . 124

Instructions for use PulmoVista 500 SW 1.2n 117


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 80 to 100 % of maximum patient auxiliary current
conforming to IEC 60601-1 (3rd edition)
Feed current frequency 80 to 130 kHz
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)

118 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 119


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 Degree of protection 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 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 as per EC Directive 93/42/EEC An- II a
nex IX

120 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 121


Technical data

Electromagnetic environment

This device may only be used in environments


specified in section "Environment 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

122 Instructions for use PulmoVista 500 SW 1.2n


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.

Instructions for use PulmoVista 500 SW 1.2n 123


Technical data

Connections to IT networks

In an IT network, data can be exchanged by means Subsequent changes to the passive USB storage
of wired or wireless technologies. An IT network medium, e.g., formating using different operating
can be any data interface (e.g., RS232, LAN, USB, systems or loading different data using an IT device
printer interface) that is described in standards and may impair the correct operation of the data
conventions. transmission from or to the USB storage medium.
The following IT networks can be established using The USB port of PulmoVista 500 does not include
the RS232 interface and the USB port of an integrated virus scanner and has no firewall
PulmoVista 500: installed. This does not pose a risk to the correct
medical operation of the device, but transmitted
– RS232 interface according to EIA RS-232
data can be distorted, damaged or deleted.
(CCITT V.24/V.28) for MEDIBUS and
MEDIBUS.X in a point-to-point connection Removal of the USB storage medium or the data
(exclusively for the Dräger devices specified in cable to the Dräger device during data transmission
these instructions for use with a data may damage the transmitted data.
connection validated by Dräger)
Any other use of PulmoVista 500 interfaces is
– Interfaces based on USB 1.1 or USB 2.0 to prohibited and may lead to new risks for patients,
connect a passive USB storage medium without users and third parties.
its own voltage supply or to connect a USB card
reader supplied by Dräger
PulmoVista 500 can receive data from the specified
Dräger devices via the MEDIBUS or MEDIBUS.X
interface and supports the following functions:
– Display of waveforms and parameter data
– Recording and saving of data
PulmoVista 500 can save EIT files with the
following data on a USB storage medium via the
USB interface:
– EIT data
– Patient data
– Data from a Dräger device received via
MEDIBUS or MEDIBUS.X
Software options can be enabled via the USB port.
Only use SIM cards and USB-SIM card readers
supplied by Dräger.
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.

124 Instructions for use PulmoVista 500 SW 1.2n


Principles of operation

Principles of operation

Image generation . . . . . . . . . . . . . . . . . . . . . . 126


Determination of regional bioelectric
properties within the thorax . . . . . . . . . . . . . . . 126
Image reconstruction . . . . . . . . . . . . . . . . . . . . 127
Bioelectric properties of lung tissue . . . . . . . . . 128
Functional EIT . . . . . . . . . . . . . . . . . . . . . . . . . 129
Some examples of EIT images from
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 129
Special considerations when using the
Diagnostics view. . . . . . . . . . . . . . . . . . . . . . . . 133
Electrode plane. . . . . . . . . . . . . . . . . . . . . . . . . 135

Information displayed by PulmoVista 500 . . 136


Dynamic image. . . . . . . . . . . . . . . . . . . . . . . . . 136
Status images . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Impedance waveforms . . . . . . . . . . . . . . . . . . . 137
Numeric values. . . . . . . . . . . . . . . . . . . . . . . . . 137

Definition of baseline frames . . . . . . . . . . . . 142


Main and Full-screen image views . . . . . . . . . . 142
End-insp. trend and Diagnostics views. . . . . . . 143
EELI trend view . . . . . . . . . . . . . . . . . . . . . . . 144
Data review page (optional with the option
ADAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Definitions for color scales and scales of


impedance waveforms . . . . . . . . . . . . . . . . . . 145
Main and Full-screen image views . . . . . . . . . . 145
End-insp. trend, EELI trend, and
Diagnostics views . . . . . . . . . . . . . . . . . . . . . . . 146
Data review page (optional with the option
ADAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Principles of breath detection and


determination of the tidal rate . . . . . . . . . . . . 147

Literature references . . . . . . . . . . . . . . . . . . . 148

Instructions for use PulmoVista 500 SW 1.2n 125


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 each consisting of 13 voltage measurements. The
current "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.

126 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 127


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 148

128 Instructions for use PulmoVista 500 SW 1.2n


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 CT distribution of ventilation between normal-weight
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 1.2n 129


Principles of operation

EIT and CT images from a patient with dorsal The following known effects may lead to negative
pleural effusion 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
baseline level.
– Pendelluft: The baseline frame taken at the end
of expiration defines, for every pixel, the zero
level. If all parts of the lung increase and
decrease their impedance simultaneously, then
negative values do not occur. However, when a
lung region has different filling characteristics to
549

A fluid accumulation such as a pleural effusion other lung regions, the minimum of this
represents a non-ventilated area and is displayed particular region may differ from the defined
by PulmoVista 500 in black or purple color. In the zero level. This may then result in negative
CT scan the same region is displayed in bright values in this region.
color. – Artifacts: During EIT measurements, various
conditions may cause artifacts, which need to
be considered during interpretation of images.
550

Interpretation of negative impedance changes


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.

130 Instructions for use PulmoVista 500 SW 1.2n


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
level of end-expiratory lung volume. For
according to IEC 60601-1-2.
example, the same tidal volume of two
The EIT measurements performed by spontaneous breaths or mechanical breaths
PulmoVista 500 and the derived parameters are applied at very different PEEP levels may result
not defined as a measuring function according to in different impedance changes. Typically, the
the Directive 93/42/EEC concerning Medical higher the PEEP levels, the lower are the
Devices. related impedance changes. For interpretation
of tidal impedance changes make sure to also
When interpreting EIT data, the following
consider the volume information provided by
considerations must be taken into account:
the ventilator.
– PulmoVista 500 provides a mean spatial
– Body movements can cause artifacts.
resolution of approximately 20 % of the thoracic
diameter. The spatial resolution decreases – Strong electromagnetic fields of sensitive
towards the center of the body. frequency bands may create artifacts when the
measurement circuit of the EIT system is
– The displayed shape of the electrode plane
exposed to these fields. Possible pathways of
does not exactly match the geometry of the
this energy are, for example, the patient, the
patient.
mains power supply, the trunk cable, and the
– The displayed position of impedance changes patient cable.
does not always exactly match where the
– Low pass filtering and band pass filtering may
impedance change occurred.
cause a phase shift and thus a delayed display
– The impedance changes determined by of impedance waveforms.
PulmoVista 500 reflect an interaction of
– The use of pulsating air suspension mattresses
different physiological processes rather than
induces a slow, steady modulation of the
the effects of one isolated source.
impedance waveforms, which may compromise
– Changes of PEEP, extravascular lung water, the interpretation of EIT data. This slow
body position, position of the electrode belt, and modulation has especially to be taken into
skin-electrode resistance (e.g., after applying account when interpreting the EELI trend
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 1.2n 131


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 value concurs with ROI 1
(B), but in ROI 2 the overshoot leads to a maximum
value (C).

132 Instructions for use PulmoVista 500 SW 1.2n


Principles of operation

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

Instructions for use PulmoVista 500 SW 1.2n 133


Principles of operation

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 CL LP and CL HP
and CL and CW 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 CL LP and
CL HP and CL and CW 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 overdistented.

134 Instructions for use PulmoVista 500 SW 1.2n


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 1.2n 135


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 126) 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 (B,
C) of the current breath and the baseline frame (A) The tidal image represents regional distribution of
are displayed. If the end-expiratory impedance impedance changes of the last detected breath.
distribution of the current breath is identical to that The tidal image is a differential image of the end of
of the last breath, the resulting dynamic image is a inspiration compared to the beginning of
black image (B). inspiration. The tidal image is automatically
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

136 Instructions for use PulmoVista 500 SW 1.2n


Principles of operation

the last minute. The minute 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 TV global (global tidal variation) parameter
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 MTV
global (global minute tidal variation) parameter
represents the average of the global tidal variations
over the last minute. The TV global and MTV
The global impedance waveform mainly displays global parameters are always defined as 100 %,
impedance changes related to ventilation. Thus, independently of the tidal volume. They serve
there is usually a strong correlation between this solely as a reference for the display of the regional
waveform and the volume waveform displayed on tidal variations or regional minute tidal variations.
ventilators.
Regional tidal variations TV ROI represent the
dZglobal difference between the corresponding values of the
regional impedance waveforms for each breath.
Regional minute tidal variations MTV ROI
represent the average of the regional tidal
Time 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
variations show the percentage of impedance
131

change which takes place in the corresponding


In contrast to the global impedance waveform, the ROI.
four regional impedance waveforms display the
sum of impedance changes within the specified Further numeric values are displayed in the EELI
ROIs. The regional impedance waveforms allow trend view.
comparison of impedance changes in different lung The numeric value EELI global displays the
regions. deviation of the global end-expiratory status at the
cursor positions Ref and C in relation to the global
tidal variation at Ref.

Instructions for use PulmoVista 500 SW 1.2n 137


Principles of operation

The numeric value EELI ROI displays the 4 The compliance is calculated for every section
deviation of the regional end-expiratory status at and every pixel:
the cursor positions Ref and C in relation to the
global tidal variation at Ref.
In the Diagnostics view, the CL (= Compliance
Loss) and RVD (= Regional Ventilation Delay)
If no pressure values are available from the
parameters are also calculated and displayed for
ventilator, the EIP – PEEP pressure difference is
every defined section. The algorithms used for the
set to 1.
calculations are partially based on publications
which point out the following: 5 Every pixel in the selected reference section is
– The method for determining the CL HP [%] and defined as RefCompliance.
CL LP [%] parameters enables an estimation of
6 In every section and for every pixel, CL is
lung region overdistension and collapse [13]
calculated as the compliance loss of the section
– The RVD index enables the detection of cyclical
in comparison with the reference compliance.
opening and closing of lung regions [14, 15]
CLI is set to 0 if the difference results in a
positive value.
Compliance loss (CL) and compliance win (CW)
Trend data without a PEEP maneuver can be
analyzed using the Customized analysis function. 7 The global parameter CL is also calculated for
This analysis ascertains changes to the regional every section by summing up the compliance
compliance in comparison with a selectable loss percentage of all pixels (NV) of the
reference section for every displayed section. ventilated area:
These changes are printed as Compliance loss CL
and compliance win CW.
– The CL [%] parameter describes a regional
compliance loss in comparison with the 8 In every section and for every pixel, CW is
reference and is displayed in orange. calculated as the compliance win of the section
– The CW [%] parameter describes a regional in comparison with the reference compliance.
compliance win in comparison with the CWi is set to 0 if the difference results in a
reference and is displayed in cyan. negative value.
Pixels with the same compliance as in the
reference section are displayed in dark gray.
9 The global parameter CW is also calculated for
CL and CW are calculated as follows: every section by summing up the compliance
1 The EIT data is low-pass filtered with a cut-off win percentage of all pixels:
frequency of 80 min–1. The artifact filter is
activated.
2 If a section contains several spontaneous
breaths, these are averaged to ascertain the
tidal variation TV.
3 The tidal variation TVi is calculated for every
pixel within the ventilated area.

138 Instructions for use PulmoVista 500 SW 1.2n


Principles of operation

Compliance loss (CL LP and CL HP) 6 In every section and for every pixel, CL LPi is
calculated as the compliance loss percentage
CL images represent the PEEP-induced regional
of the section in comparison with the maximum
compliance loss for various levels of a PEEP
compliance. CL LPi is set to 0 if the observed
maneuver.
section is at a higher PEEP level than the
With this method, both of the following conditions section with the maximum compliance.
are differentiated for every pixel:
– The CL LP parameter describes the regional
compliance loss in comparison with the
ascertained maximum regional compliance 7 The global parameter CL LP is also calculated
towards lower PEEP levels and is displayed in as the weighted average of all pixels of the
white. ventilated area:
– The CL HP parameter describes the regional
compliance loss in comparison with the
ascertained maximum regional compliance
towards higher PEEP levels and is displayed in 8 In every section and for every pixel, CL HPi is
orange. calculated as the compliance loss percentage
of the section in comparison with the maximum
Pixels which experience no compliance loss are
compliance. CL HPi is set to 0 if the observed
displayed in dark gray.
section is at a lower PEEP level than the section
CL LP and CL HP are calculated as follows: with the maximum compliance.
1 The EIT data is low-pass filtered with a cut-off
frequency of 80 min–1. The artifact filter is
activated.
9 The global parameter CL HP is also calculated
2 If a section contains several spontaneous as the weighted average of all pixels of the
breaths, these are averaged to ascertain the ventilated area:
tidal variation TV.
3 The tidal variation TVi is calculated for every
pixel within the ventilated area.
4 The compliance is calculated for every section Regional ventilation delay (RVD)
and every pixel:
During a low-flow maneuver, the algorithm for
quantifying the RVD defines regional inspiratory
delays which can be linked to cyclical opening and
closing [14, 15].
If no pressure values are available from the The RVD parameter defines the extent of the
ventilator, the EIP – PEEP pressure difference is temporal delay of the regional inspiration (derived
set to 1. from the regional impedance waveform) in
5 The maximum compliance is defined for every comparison with the global inspiration (derived
pixel of all sections. from the global impedance waveform) for every
pixel within the contour of the ventilated area.

Instructions for use PulmoVista 500 SW 1.2n 139


Principles of operation

The RVD is calculated using the following steps: Global RVD parameters
1 The EIT data is low-pass filtered with a cut-off Depending on the configuration, PulmoVista 500
frequency of 80 min–1. The artifact filter is calculates one of two global RVD parameters which
activated. represent either the inhomogeneity of the regional
inspiration progressions or the ratio of the area
2 If a section contains several spontaneous
affected by the RVD to the entire ventilated area.
breaths, these are averaged to ascertain the
RVD parameter. – Standard deviation of the RVD (RVD SD)
deviation [14, 15]. To calculate the RVD SD
3 A second, adjustable low-pass filter, which only
parameter, indicated as % of Ti, the standard
has an effect on the impedance values used for
deviation of all RVD pixel values is defined
the RVD parameter, is also activated.
within the ventilated area. Therefore, the RVD
4 Only pixels within the ventilated area are SD parameter describes the inhomogeneity of
analyzed. the regional inspiration progressions. RVD SD
is calculated as follows:
5 The Ti start and Ti end moments are defined
for every section based on the global
impedance waveform by ascertaining the start
and end of the inflation during a low-flow
maneuver. If the section does not contain a low- – Ratio of the RVD (RVD Ratio)
flow maneuver, the start and end of the The RVD Ratio (indicated in %), which indicates
inspiration of the regular spontaneous breaths the ratio of the number of pixels affected by the
are ascertained. RVD (NRVD) to the total number of pixels (NV)
within the ventilated area, is calculated as the
6 The time Ti is calculated, i.e. the time period second RVD parameter. The RVD Ratio
between Ti start and Ti end. parameter is calculated as follows:
7 For the global impedance waveform: T40glob,
the moment at which the global impedance
waveform reaches 40 % of its tidal variation, is
ascertained.
8 For every pixel within the ventilated area: T40i,
the moment at which the regional impedance
waveform reaches 40 % of its tidal variation, is
ascertained.
9 Calculation of the RVD parameter:

The numeric RVD value represents the inspriatory


delay of the observed pixel. The value is based on
the global inspiratory time Ti and therefore
represented as a percentage.
If the value of the RVD parameter exceeds the RVD
cut-off value set by the user, the affected pixels are
marked in yellow in the corresponding tidal image.

140 Instructions for use PulmoVista 500 SW 1.2n


Principles of operation

Improvement of the algorithms used to – RVD is only used during low-flow maneuvers.
calculate CL LP, CL HP, and RVD Up to now, there was no research analyzing
how slowly a ventilation pressure needs to rise
Several limitations were identified in the algorithms
for the RVD to continue returning usable data.
described in the referenced publications for the
definition of CL [13] and RVD [14, 15]. These Improvement: The RVD can be calculated for
limitations were removed as follows with the every spontaneous breath. However, the
implementation in PulmoVista 500: inspiratory rise must be considered during RVD
interpretation.
– During PEEP maneuvers, the end-expiratory
lung volume (EELI) is generally high at high – The respective PEEP values need to be known
PEEP levels and low at low PEEP levels. In to automatically assign sections to the
contrast, the tidal variation (TV) remains respective PEEP levels.
constant during volume-controlled ventilation.
Improvement: The various PEEP levels are
Because of the calculation of relative
indirectly ascertained based on the identified
impedance changes in comparison with
EELI levels. This enables automatic detection
a baseline, this leads to a loss in the tidal
of the sections, even if no PEEP values are
variations towards higher PEEP levels, which
available.
are not, however, linked to changes in the tidal
volume. – The calculation of CL LP, CL HP, and RVD in
regions with very small tidal variations is very
Improvement: The tidal variations are adjusted
susceptible to errors.
using a correction factor.
Improvement: Regions with tidal variations
– The CL LP and CL HP values require
below 10 % of the maximum tidal variation are
knowledge of the pressure values (EIP, PEEP)
excluded from the calculation.
in order to calculate the regional compliance.
This requires the availability of the pressure – Filter settings are not described in every
values from the ventilator which are, however, published analysis, meaning that they could
often not available. vary from case to case, especially for
suppressing cardiac impedance changes.
Improvement: The CL LP and CL HP are still
calculated, even if no pressure values are Improvement: Uniform filter settings are used to
available. This makes it possible to evaluate all calculate CL LP, CL HP, and RVD. A low-pass
maneuvers which are performed during filter with a cut-off frequency of 80 min–1 is used
constant pressure-controlled ventilation. to suppress cardiac impedance changes. If the
definition of the RVD is still disturbed by cardiac
– RVD times are always indicated as positive
impedance changes despite the filter, the user
values which are ascertained from the earliest
can configure an additional low-pass filter which
to latest pixel. This makes it difficult to
only affects the RVD definition.
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.

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

Instructions for use PulmoVista 500 SW 1.2n 141


Principles of operation

Definition of baseline frames

Main and Full-screen image views dZglobal


BFA BFB BFC
The Main and Full-screen image views focus on
providing information related to functional
impedance changes due to ventilation. 0 0
0 0 0
All information displayed in Main and Full-screen
image views (status images, impedance A B C Time

040
waveforms, and parameters) is based on the
A Referred to BFA
dynamic image which continuously displays
relative impedance changes referenced to a B Referred to BFB
baseline as a series of cross-sectional images.
C Referred to BFC
Each single image represents the reconstructed
deviations between the current frame and a
baseline frame (BF).
The frame at the end of expiration from the last
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
detected maxima of the global impedance
waveform.
As all frames are referred to the smallest frame of
the last breath, usually only positive changes are
displayed in the dynamic image.

Baseline update (Breath)


Typically, the baseline frame is updated
continuously after each detected end of inspiration.
The update of the baseline frame can be compared
to the way a volume waveform of a ventilator
returns to zero value at the end of each breath.
Consequently, all effects that may impair absolute
impedance values and thus lead to end-expiratory
offsets in the impedance waveform are typically
eliminated. Only changes which occur within a
respiratory cycle are displayed. Changes are
mainly caused by ventilation-related impedance
changes. If not suppressed by filter settings,
impedance changes related to cardiac activity,
which also occur within the respiratory cycle, are
displayed as well.

142 Instructions for use PulmoVista 500 SW 1.2n


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 of breaths
impedance. The baseline update after each over a longer 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 views. Under those dZglobal
rare conditions, the breath-by-breath baseline up- BFRef BFC
date leads to large offsets in the impedance wave-
forms which may compromise their interpretability.
In such cases, it is recommended that the baseline
update option is set to Time scale.
Ref C Time
042

Instructions for use PulmoVista 500 SW 1.2n 143


Principles of operation

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

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
The Change: C minus Ref image of the EELI
trend view displays the changes of end-expiratory
lung volume within the electrode plane. In contrast,

144 Instructions for use PulmoVista 500 SW 1.2n


Principles of operation

Definitions for color scales and scales of impedance waveforms

Main and Full-screen image views The zero position of the color scale is always
located in a position which provides 85 % for the
After image reconstruction, the relative impedance display of positive changes (A). The scalar
changes that have been determined for each of the endpoints of positive and negative impedance
pixels are translated into a color scale. Regions changes are of the same magnitude. However,
with impedance changes of less than 10 % of the positive impedance changes (A) are represented
determined maximum regional impedance change over 85 % of the color scale while negative
are represented in black. Impedance changes impedance changes (B) are compressed to 15 % of
above 10 % of the maximum regional impedance the color scale.
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
end-inspiratory images typically contain some

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

Instructions for use PulmoVista 500 SW 1.2n 145


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 views always contain identical on the maximum impedance changes of the
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 compliance loss images
also rescaled automatically.
shows CL HP in orange and CL LP in white.
Regions with no compliance loss are displayed in
End-insp. trend view dark gray.
The auto-scaling of the two status images in the
End-insp. trend view is based on the maximum
impedance changes in these images. The two Data review page (optional with the
status images and the resulting differential image option ADAP)
have the same scalar endpoints.
The auto-scaling on the Data review page is based
The scaling is based on the status image with the on the minimum and maximum values contained in
smaller maximum impedance change. This scaling the EIT data file which has been selected.
may result in white saturated areas in the other
status image.

146 Instructions for use PulmoVista 500 SW 1.2n


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.

Instructions for use PulmoVista 500 SW 1.2n 147


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 im-
pedance 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.

148 Instructions for use PulmoVista 500 SW 1.2n


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.

Instructions for use PulmoVista 500 SW 1.2n 149


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150 Instructions for use PulmoVista 500 SW 1.2n


List of accessories

List of accessories

WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of ac-
cessories listed in the current list of accesso-
ries. If other, incompatible accessories are
used, there is a risk of patient injury due to
medical device failure.
Dräger recommends that the medical device is
only used together with accessories listed in
the current list of accessories.

Name/Description Order-No.
Trunk cable 8420048
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 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
Retrofit kit ADAP 8420006

PulmoVista 500 part number: 8420000

Instructions for use PulmoVista 500 SW 1.2n 151


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152 Instructions for use PulmoVista 500 SW 1.2n


Index

Index

Numeric D
15-electrode mode . . . . . . . . . . . . . . . . . . . . . . . 57 Data import
configuring . . . . . . . . . . . . . . . . . . . . . . . . . 86
A Data recording
configuring . . . . . . . . . . . . . . . . . . . . . . . . . 94
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Data review . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
additional functions . . . . . . . . . . . . . . . . . . . 76 Date and time settings . . . . . . . . . . . . . . . . . . . 90
Airway pressure unit . . . . . . . . . . . . . . . . . . . . . 90 EELI trend . . . . . . . . . . . . . . . . . . . . . . . . 64, 65
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Default settings . . . . . . . . . . . . . . . . . . . . . . . . . 91
Applications page . . . . . . . . . . . . . . . . . . . . . . . 92 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Artifact filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Device combinations . . . . . . . . . . . . . . . . . . . 121
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Dialog windows . . . . . . . . . . . . . . . . . . . . . . . . 35
B Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Baseline frames . . . . . . . . . . . . . . . . . . . . . . . . 142 Disinfecting
patient interface . . . . . . . . . . . . . . . . . . . . 109
surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . 109
C Disk space . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Cable connectors . . . . . . . . . . . . . . . . . . . . . . . . 27 Display
Calibrating the touchscreen . . . . . . . . . . . . . . . . 36 configuring . . . . . . . . . . . . . . . . . . . . . . . . . 82
Calibration Displaying changes . . . . . . . . . . . . . . . . . . 62, 71
restarting . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
CL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Dräger default settings . . . . . . . . . . . . . . . . . . . 91
CL HP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Dynamic image . . . . . . . . . . . . . . . . . . . . . . . . 136
CL LP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Cleaning E
reprocessing procedures . . . . . . . . . . . . . . 108
Clear data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 EIT data
Cockpit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 refreshing . . . . . . . . . . . . . . . . . . . . . . . . . . 65
hardware elements . . . . . . . . . . . . . . . . . . . 32 EIT settings
preparing . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 configuring . . . . . . . . . . . . . . . . . . . . . . . . . 88
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Electrode belt . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 attaching . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Connections to IT networks . . . . . . . . . . . . . . . 124 Electrode plane . . . . . . . . . . . . . . . . . . . . . . . 135
Contour of the ventilated area . . . . . . . . . . . . . . 85 Electromagnetic compatibility . . . . . . . . . . . . . . 10
Copying to USB . . . . . . . . . . . . . . . . . . . . . . . . . 96 EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cursor position . . . . . . . . . . . . . . . . . . . . . . . . . 64 EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 121
Cut-off frequency . . . . . . . . . . . . . . . . . . . . . . . . 83 End-inspiratory trend . . . . . . . . . . . . . . . . . . . . 64
CW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Ending operation . . . . . . . . . . . . . . . . . . . . . . . 80
Environment of use . . . . . . . . . . . . . . . . . . . . . 18
Export screenshot . . . . . . . . . . . . . . . . . . . . . . 71

Instructions for use PulmoVista 500 SW 1.2n 153


Index

F N
File handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 New measurement . . . . . . . . . . . . . . . . . . . . . . 57
deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Numeric values . . . . . . . . . . . . . . . . . . . . . . . . 137
File length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Filter settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 O
Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Frame rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Operating concept . . . . . . . . . . . . . . . . . . . . . . 31
Freeze display . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Operating frequency . . . . . . . . . . . . . . . . . . . . . 89
Full-screen image . . . . . . . . . . . . . . . . . . . . . . . 63 adjusting . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Option
G ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 76

General WARNINGS and CAUTIONS . . . . . . . 11 P


Getting started . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Patient cable . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
H Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Patient interface . . . . . . . . . . . . . . . . . . . . . . . . 25
Header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 attaching . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Position of the user . . . . . . . . . . . . . . . . . . . . . . 43
I Potential equalization . . . . . . . . . . . . . . . . . . . . 40
Power supply module . . . . . . . . . . . . . . . . . . . . 24
Image generation . . . . . . . . . . . . . . . . . . . . . . 126 Principles of operation . . . . . . . . . . . . . . . . . . 125
Impedance waveforms . . . . . . . . . . . . . . . . . . 137 Product specific page . . . . . . . . . . . . . . . . . . . . 92
Indications/contraindications . . . . . . . . . . . . . . . 16 PulmoVista 500
Install applications . . . . . . . . . . . . . . . . . . . . . . . 92 components . . . . . . . . . . . . . . . . . . . . . . . . 20
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Internal battery . . . . . . . . . . . . . . . . . . . . . . . . . 39 R
L Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Reference function
Language settings . . . . . . . . . . . . . . . . . . . . . . . 90 displaying data . . . . . . . . . . . . . . . . . . . . . . 61
LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 parameters . . . . . . . . . . . . . . . . . . . . . . . . . 61
Literature references . . . . . . . . . . . . . . . . . . . . 148 waveform . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Reprocessing procedure . . . . . . . . . . . . . . . . 108
ROI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
M defining as layers . . . . . . . . . . . . . . . . . . . . 59
Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 35 defining as quadrants . . . . . . . . . . . . . . . . . 60
Main view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 setting as free . . . . . . . . . . . . . . . . . . . . . . . 60
Mains power supply . . . . . . . . . . . . . . . . . . . . . . 39 Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Manual disinfection . . . . . . . . . . . . . . . . . . . . . 108 RVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Measurement RVD ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 RVD SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
MEDIBUS, MEDIBUS.X
configuring . . . . . . . . . . . . . . . . . . . . . . . . . . 86 S
connecting to a Dräger device . . . . . . . . . . . 42
trend display . . . . . . . . . . . . . . . . . . . . . . . . 87 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Medical contraindications . . . . . . . . . . . . . . . . . 16 Safety instructions . . . . . . . . . . . . . . . . . . . . . 106
Medical indications . . . . . . . . . . . . . . . . . . . . . . 16 Screen layout . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Message-Cause-Remedy . . . . . . . . . . . . . . . . . 98 configuring . . . . . . . . . . . . . . . . . . . . . . . . . 82
Monitoring area . . . . . . . . . . . . . . . . . . . . . . . . . 34 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . .91, 111
Monitoring sessions . . . . . . . . . . . . . . . . . . . . . . 52 Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Signal check . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

154 Instructions for use PulmoVista 500 SW 1.2n


Index

Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Simulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Status images . . . . . . . . . . . . . . . . . . . . . . . . . 136
SW versions page . . . . . . . . . . . . . . . . . . . . . . . 92
Switching off . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Switching on . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
System settings . . . . . . . . . . . . . . . . . . . . . . . . . 90
country-specific . . . . . . . . . . . . . . . . . . . . . . 90
System setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

T
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . 117
Thoracic contour . . . . . . . . . . . . . . . . . . . . . . . . 85
Time scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Transporting patients within the hospital . . . . . . 41
Trolley
moving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
parking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
preparing . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Trunk cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
connecting . . . . . . . . . . . . . . . . . . . . . . . . . . 52

U
USB space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
User interface . . . . . . . . . . . . . . . . . . . . . . . . . . 34

V
Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . 109
Volume waveform . . . . . . . . . . . . . . . . . . . . . . . 87

Z
Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67, 69
Zoom in/zoom out . . . . . . . . . . . . . . . . . . . . 64, 66

Instructions for use PulmoVista 500 SW 1.2n 155


These instructions for use only apply to the
following device with the serial number filled in:
PulmoVista 500 SW 1.2n
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.

Directive 93/42/EEC
concerning Medical Devices

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

9055985 – GA 5667.100 en
© Drägerwerk AG & Co. KGaA
Edition: 1 – 2017-06
Dräger reserves the right to make modifications
to the medical device without prior notice.

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