isolette_8000_instructions_for_use_edition_7_may_20.pdf
Page 1
Instructions for Use
Isolette 8000
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Infant Incubator
Page 2
Typographical conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet points indicate individual actions or different options for action.
–
Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
related illustration.
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for example, Cal, Air, or Audio Paused/Reset.
Screen reproductions
The reproductions of screen content in the instructions for use can differ from the content actually
shown on the screen.
A Letters in illustrations denote elements referred
to in the text.
Trademarks
Trademark
Trademark owner
Trademark
Trademark owner
Care-forMe™
Dräger
CaviCide®
Metrex Research Corporation
VueLink™
Philips Medical Systems
Infinity®
Dräger
Isolette®
Dräger
SoftBed™
Dräger
terralin® pro- Schülke & Mayr
tect
Earth™
Safety information definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important information about a potentially hazardous situation
which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to
the medical device or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
2
Instructions for Use Isolette 8000
Page 3
Definition of target groups
For this product, users, service personnel, and
experts are defined as target groups.
These target groups must have received instruction
in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined target groups.
Users
Users are persons who use the product in accordance with its intended use.
Service personnel
Service personnel are persons who are responsible
for the maintenance of the product.
Service personnel must be trained in the maintenance of medical devices and install, reprocess,
and maintain the product.
Experts
Experts are persons who perform repair or complex
maintenance work on the product.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
Instructions for Use Isolette 8000
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Instructions for Use Isolette 8000
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Contents
Contents
Typographical conventions . . . . . . . . . . . . . . . .
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety information definitions . . . . . . . . . . . . . .
Definition of target groups . . . . . . . . . . . . . . . .
2
2
2
3
For your safety and that of your patients. . .
7
General safety information . . . . . . . . . . . . . . . . 8
Product-specific safety information. . . . . . . . . . 12
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Environment of use. . . . . . . . . . . . . . . . . . . . . . 20
Indications/contraindications . . . . . . . . . . . . . . 20
Attaching the hood/shell assembly to the
VHA stand . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching accessories . . . . . . . . . . . . . . . . . .
Installing the weighing system (accessory) . . .
Installing the humidity system (option) . . . . . .
Installing the servo oxygen control system
(option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Installing the 100% oxygen calibration
fixture (optional). . . . . . . . . . . . . . . . . . . . . . . .
Installing the breathing hose holder
(accessory) . . . . . . . . . . . . . . . . . . . . . . . . . . .
46
48
49
51
52
54
56
Getting started . . . . . . . . . . . . . . . . . . . . . . . .
57
System start-up . . . . . . . . . . . . . . . . . . . . . . . .
Operational checkout procedure . . . . . . . . . . .
58
59
22
23
24
25
26
27
27
28
28
29
29
30
31
32
33
35
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
71
Operating concept . . . . . . . . . . . . . . . . . . . . . 37
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
93
Front panel of controller . . . . . . . . . . . . . . . . . .
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hard keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Soft keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
LED indicators . . . . . . . . . . . . . . . . . . . . . . . . .
38
39
40
41
43
Safety information . . . . . . . . . . . . . . . . . . . . .
Alarm priority . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm indication. . . . . . . . . . . . . . . . . . . . . . . .
Disabling the alarm tone sequence . . . . . . . . .
94
94
95
96
Trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
97
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Trend display . . . . . . . . . . . . . . . . . . . . . . . . . .
98
Unpackaging. . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Proper assembly. . . . . . . . . . . . . . . . . . . . . . . . 46
Configuration. . . . . . . . . . . . . . . . . . . . . . . . .
99
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right side view . . . . . . . . . . . . . . . . . . . . . . . . .
Left side view . . . . . . . . . . . . . . . . . . . . . . . . . .
Sensor module . . . . . . . . . . . . . . . . . . . . . . . . .
Isolette 8000 overview . . . . . . . . . . . . . . . . . . .
Oxygen system. . . . . . . . . . . . . . . . . . . . . . . . .
Humidity system (option) . . . . . . . . . . . . . . . . .
Condensation management system (option) . .
Weighing system (accessory). . . . . . . . . . . . . .
Functional description. . . . . . . . . . . . . . . . . . . .
External devices . . . . . . . . . . . . . . . . . . . . . . .
Convenience outlets . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Technical definitions . . . . . . . . . . . . . . . . . . . . .
Setting the temperature. . . . . . . . . . . . . . . . . . 72
Setting the humidity (option) . . . . . . . . . . . . . . 77
Setting the servo control oxygen (option) . . . . 80
Manual control oxygen usage (option) . . . . . . 82
Variable height adjustment . . . . . . . . . . . . . . . 83
Infant placement . . . . . . . . . . . . . . . . . . . . . . . 83
Scale measurements (accessory) . . . . . . . . . . 84
X-ray tray usage . . . . . . . . . . . . . . . . . . . . . . . 87
Dräger Infinity Delta, Delta XL, and Kappa
monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
VueLink™ monitoring . . . . . . . . . . . . . . . . . . . 88
Oxygen sensor calibration (option) . . . . . . . . . 89
Scale calibration (accessory) . . . . . . . . . . . . . 91
System shut-down. . . . . . . . . . . . . . . . . . . . . . 92
System configuration menu . . . . . . . . . . . . . . 100
Instructions for Use Isolette 8000
5
Page 6
Contents
Problem solving . . . . . . . . . . . . . . . . . . . . . . . 103
Alarm messages. . . . . . . . . . . . . . . . . . . . . . . . 104
Problems/alarm conditions without alarm messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
System prompt messages . . . . . . . . . . . . . . . . 115
Cleaning, disinfection, and sterilization. . . . 119
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
General cleaning . . . . . . . . . . . . . . . . . . . . . . . 120
Disinfecting. . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Disassembly for cleaning . . . . . . . . . . . . . . . . . 121
Cleaning procedures . . . . . . . . . . . . . . . . . . . . 126
Reassembly after cleaning . . . . . . . . . . . . . . . . 130
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Preventive maintenance. . . . . . . . . . . . . . . . . . 136
Maintenance instructions . . . . . . . . . . . . . . . . . 139
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Disposing of the medical device. . . . . . . . . . . . 146
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 147
Isolette 8000 system . . . . . . . . . . . . . . . . . . . . 148
Humidity system (option) . . . . . . . . . . . . . . . . . 151
Oxygen control system . . . . . . . . . . . . . . . . . . 151
Non-OIML/NAWI weighing system
(accessory). . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
OIML/NAWI weighing system (accessory) . . . . 152
Rail accessory weight limitations . . . . . . . . . . . 153
Non-rail accessory weight limitations . . . . . . . . 153
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 154
List of accessories . . . . . . . . . . . . . . . . . . . . . 159
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
6
Instructions for Use Isolette 8000
Page 7
For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . .
8
Strictly follow these instructions for use . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sterile accessories . . . . . . . . . . . . . . . . . . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection to other devices . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Functional safety . . . . . . . . . . . . . . . . . . . . . . .
Information on electromagnetic compatibility . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restrictions for use. . . . . . . . . . . . . . . . . . . . . .
8
8
8
8
9
9
9
9
9
10
10
10
11
11
11
11
11
Product-specific safety information . . . . . . . 12
Instructions for Use Isolette 8000
7
Page 8
For your safety and that of your patients
General safety information
The following WARNING and CAUTION statements apply to general operation of the medical
device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this medical
device.
Strictly follow these instructions for use
WARNING
Risk of incorrect operation and of incorrect
use
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the purpose specified under "Intended use"
on page 20 and in conjunction with appropriate patient monitoring (see page 10).
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety information statements constitutes a use of the
medical device that is inconsistent with its
intended use.
Maintenance
WARNING
Risk of medical device failure and of patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.
Safety checks
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Accessories
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of
accessories listed in the current list of accessories. 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 Isolette 8000
Page 9
For your safety and that of your patients
WARNING
Risk of equipment damage and risk of injury
Reusing, reprocessing, or sterilizing disposable items can lead to a failure of the medical device and cause injury to the patient.
Do not reuse, reprocess, or sterilize disposable items. Disposable items were designed, tested, and manufactured for one-time use only.
Sterile accessories
Not for use in areas of explosion hazard
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur.
Safe connection with other electrical
equipment
CAUTION
Risk of medical device failure and of patient injury
CAUTION
Risk of patient injury
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged, or if
there are other signs of non-sterility.
Electrical connections to equipment not listed in
these instructions for use or these assembly
instructions must only be made when approved
by each respective manufacturer.
Single-use accessories must not be reused,
reprocessed, or resterilized.
Connection to other devices
Connected devices
WARNING
Risk of electric shock and of device malfunction
Any connected devices or device combinations not complying with the requirements
mentioned in these instructions for use 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 connected devices or device combinations.
Instructions for Use Isolette 8000
Device combinations (Dräger devices + Dräger devices or Dräger devices + third-party devices) approved by Dräger (see instructions for use of individual devices) meet the requirements of the following standards:
–
IEC 60601-1 (2nd or 3rd edition)
Medical Electrical Equipment Part 1: General
requirements for basic safety and essential performance
–
IEC 60601-1-2
Medical Electrical Equipment Part 1-2: General requirements for basic safety
Collateral standard: Electromagnetic Compatibility - Requirements and Tests
–
IEC 60601-1-8
Medical Electrical Equipment Part 1-8: General requirements for basic safety
Collateral standard: Alarm systems - General requirements, tests, and guidance for
alarm systems in medical electrical equipment and medical electrical systems
9
Page 10
For your safety and that of your patients
If a device combination is not approved by Dräger,
proper operation of the devices can be compromised.
The operator must ensure that the device combination meets the applicable standards.
Strictly observe instructions for use and assembly
instructions of all connected devices.
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.
The instructions for use do not contain any information on the following points:
–
Risks that are obvious to users
–
Consequences of obvious improper use of the
medical device
–
Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
Patient safety can be achieved by a wide variety of
means ranging from electronic surveillance of medical device performance and patient condition to
direct observation of clinical signs.
The responsibility for selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Functional safety
The essential performance consists of:
–
Skin temperature regulation
The skin temperature setting (target value) is
compared to the actual skin temperature and is
regulated.
–
Air temperature regulation
The air temperature setting (target value) is
compared to the actual ambient air temperature
and is regulated.
–
O2 regulation
The O2 value setting (target value) is compared
to the actual ambient O2 concentration and is
regulated.
The medical device is equipped with basic safety
features to reduce the possibility of patient injury
while the cause of an alarm is remedied.
WARNING
Risk of malfunction
Unauthorized modifications to the medical
device may lead to malfunctions.
This medical device must not be modified
without the permission of Dräger.
Patient monitoring
The user of the medical device is responsible for
choosing a suitable patient monitoring system that
provides appropriate information on medical device
performance and patient condition.
10
Instructions for Use Isolette 8000
Page 11
For your safety and that of your patients
Information on electromagnetic
compatibility
General information on electromagnetic compatibility (EMC) according to international EMC standard
IEC 60601-1-2:
Installing accessories
CAUTION
Risk of device failure
Install accessories to the basic device in accordance with the instructions for use of the basic
device. Make sure that there is a safe connection
to the basic device.
Medical electrical equipment is subject to special
precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and
put into operation in accordance with the EMC
information provided on page 154.
Strictly observe instructions for use and assembly
instructions.
Portable and mobile radio frequency communication equipment can affect medical electrical equipment.
Storing the instructions for use
WARNING
Risk of electric shock
Do not connect connectors with an
ESD warning symbol and do not
touch their pins without implementing ESD protective measures. Such protective measures can include antistatic
clothing and shoes, touching a potential
equalization pin before and during connection
of the pins, or using electrically insulating and
antistatic gloves.
All users concerned must be instructed in
these ESD protective measures.
WARNING
Risk of device failure
Electromagnetic fields can compromise
proper operation of the device. Electromagnetic fields are generated by, e.g., radio frequency communication equipment such as:
- Mobile phones
- Radio frequency electrosurgical equipment
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.
Training
Training for users is available from the Dräger organization responsible, see www.draeger.com.
Restrictions for use
CAUTION
Device for use in healthcare facilities only and
exclusively by persons with specific training and
experience in its use.
CAUTION
Federal law (U.S.) restricts this device to sale by
or on the order of a physician.
- Defibrillators
- Shortwave therapy equipment
Use radio frequency equipment only with a
sufficient safety margin of at least 20 cm
(7.9 in).
Instructions for Use Isolette 8000
11
Page 12
For your safety and that of your patients
Product-specific safety information
Electrical precautions
Explosion precautions
WARNING
Risk of electric shock
WARNING
Risk of explosion
The total electrical current leakage of all items
powered through the incubator must be less
than 300 µA for 120 V AC/100 V AC systems
and less than 500 µA for 230 V AC systems.
Do not use in the presence of flammable anesthetics.
WARNING
Risk of electric shock
The potential for electrical shock exists with
electrical equipment. Establish policies and
procedures to educate your staff on the risks
associated with electrical equipment.
WARNING
Risk of electric shock
Due to the risk of electrical shock hazard, only
properly trained personnel with appropriate
service documentation should service the
device.
WARNING
Risk of electric shock
To avoid the risk of electrical shock, this
equipment must only be connected to a supply mains with protective earth (protective
ground).
CAUTION
Risk of equipment damage
To prevent equipment damage or accidental
power disconnections, do not connect a power
cable from the incubator controller directly to an
AC wall socket.
Always provide power to the incubator by using
the power cable coming directly from the stand.
12
WARNING
Risk of explosion
Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air
enriched with oxygen.
Keep matches, and all other sources of ignition, out of the room in which the incubator is
located.
WARNING
Risk of explosion
Small quantities of flammable agents, such as
ethyls and alcohol, left in the incubator may
result in a fire hazard in oxygen enriched environments.
Ensure that the incubator is free of such
agents and that oxygen levels are at near
room ambient levels.
WARNING
Risk of explosion
A fire and explosion hazard exists when performing cleaning or maintenance procedures
in an oxygen-enriched environment.
Make sure that the oxygen supply is turned off
and the oxygen hose to the incubator is disconnected when performing cleaning and
maintenance procedures. Switch off or disconnect oxygen supplies during periods of
non-use.
Instructions for Use Isolette 8000
Page 13
For your safety and that of your patients
EMC precautions
WARNING
Risk of electric shock
The use of accessory equipment not complying with the equivalent safety requirements of
this equipment may lead to a reduced level of
safety of the resulting system.
All medical accessory equipment in the
patient vicinity must comply with the safety
requirements of International Electrotechnical
Commission (IEC) 60601-1 and must have the
relevant safety certifications.
CAUTION
Risk of injury or equipment damage
Use of accessories other than those listed and
approved for use in this product as original or
replacement items may result in increased emissions or decreased immunity.
CAUTION
Risk of injury or equipment damage
The equipment shall not be used adjacent to other
devices unless verification of normal operation in
the configuration in which it is to be used can be
achieved.
CAUTION
Risk of injury or equipment damage
Devices connecting to the serial port must be
compliant with EN 60601-1-2, the EMC requirement for Medical Devices.
CAUTION
Risk of injury or equipment damage
The incubator display may go blank during an episode of static discharge to the sensor module.
Instructions for Use Isolette 8000
CAUTION
Risk of injury or equipment damage
Medical electrical equipment needs special precautions regarding EMC and must be installed
and put into service according to the EMC information provided in this manual. In addition, portable and mobile RF communications equipment
can affect medical electrical equipment.
CAUTION
Risk of injury or equipment damage
Castor wheels do not control all the ESD characteristics of the device on which they are mounted.
They do, however, prevent the build-up of charge
on the wheels from friction during motion.
ESD is a product of the environment and only the
user/owner can control the ESD in that environment. Control is accomplished by maintaining a
conductive floor, equipping employees with ESD
clothing and control devices, etc.
Oxygen precautions
WARNING
Risk of death or serious injury
Improper use of supplemental oxygen may be
associated with serious side effects including
blindness, brain damage, and death. The risks
vary with each infant.
The qualified attending physician should prescribe the method, the concentration, and the
duration of oxygen administration.
WARNING
Risk of death or serious injury
If it is necessary to administer oxygen in an
emergency, notify the attending physician
immediately. Noncompliance may result in
death or serious injury.
13
Page 14
For your safety and that of your patients
WARNING
Risk of death or serious injury
WARNING
Risk of fire
The oxygen concentration inspired by an
infant does not accurately determine the partial pressure of oxygen (pO2) in the blood.
Because oxygen use increases the risk of fire,
do not place auxiliary equipment that produces sparks in an incubator.
When deemed advisable by the attending physician, measure blood pO2 by accepted clinical techniques.
WARNING
Risk of death or serious injury
WARNING
Risk of death or serious injury
After each change of oxygen flow, allow at
least 30 min to achieve new concentrations.
WARNING
Risk of death or serious injury
Oxygen levels within the incubator hood environment may be affected when the hand ports
or access panels are opened.
Make sure that all hood hand port gaskets and
tubing grommets are properly installed. Any
open gaps in the incubator hood may reduce
the incubator internal oxygen.
WARNING
Risk of death or serious injury
Compressed gas cylinders, such as oxygen
cylinders, can become hazardous projectiles
if the gas is released rapidly due to damage or
other causes.
Securely fasten the cylinder.
WARNING
Risk of death or serious injury
Disconnect the incubator from the hospital
oxygen source when oxygen is not in use.
14
The oxygen sensor is a sealed unit that contains potassium hydroxide electrolyte.
If the sensor develops a leak, discard it immediately. If contact with the skin or clothing
occurs, rinse the area with a large quantity of
water. In case of eye contact, flush the eye
immediately for at least 15 min, holding the
eye open, and call a physician.
WARNING
Risk of death or serious injury
Use only Dräger Medical recommended oxygen sensors for proper operation.
WARNING
Risk of death or serious injury
Inspect gas/oxygen service components at
regular service intervals for signs of corrosion
or damage.
WARNING
Risk of death or serious injury
Routinely inspect oxygen cells for signs of
degradation or leakage, and replace if necessary.
WARNING
Risk of death or serious injury
Use of anesthetic agents can interfere with
oxygen monitor accuracy.
Instructions for Use Isolette 8000
Page 15
For your safety and that of your patients
CAUTION
Risk of patient injury
WARNING
Risk of death or serious injury
The administration of oxygen may increase the
noise level for the baby within the incubator.
When the front or rear access panel is open,
the temperature display may not accurately
reflect the incubator temperature.
Humidity precautions
WARNING
Risk of death or serious injury
Make sure that all hand port gaskets and tubing grommets are properly installed on the
hood. Any open gaps in the incubator hood
reduce the incubator internal relative humidity.
CAUTION
Risk of injury
Fill the reservoir to the Maximum Filling Limit line.
Do not overfill. Water spillage may result.
Safety tips
WARNING
Risk of death or serious injury
Do not leave the access panel open longer
than essential.
WARNING
Risk of death or serious injury
Positively secure all hand port latches and
access panel locking knobs to avoid accidental opening.
WARNING
Risk of death or serious injury
For infant safety, do not leave the infant unattended when the access panels or hand ports
are open.
WARNING
Risk of death or serious injury
Incubator misuse may result in harm to an
infant. Only properly trained personnel should
use the incubator as directed by an appropriately qualified attending physician aware of
currently known risks and benefits.
The use of infant seats or other accessories
within the incubator that can alter the airflow
pattern may affect temperature uniformity,
temperature variability, the correlation of the
incubator temperature reading to center mattress temperature, and infant skin temperature.
WARNING
Risk of death or serious injury
WARNING
Risk of death or serious injury
If this equipment is modified, appropriate
inspection and testing must be conducted to
ensure continued safe use of the equipment.
If airflow slots in the incubator are blocked
during clinical usage, patient safety and incubator performance may be compromised.
WARNING
Risk of death or serious injury
Keep the airflow slots clear of obstructions,
such as blankets and stuffed animals.
Do not raise the hood at any time while the
infant is in the incubator. Gain access to the
infant by the access panels and hand ports.
Instructions for Use Isolette 8000
15
Page 16
For your safety and that of your patients
WARNING
Risk of death or serious injury
WARNING
Risk of death or serious injury
When the access panels are open, a curtain of
warm air flows along the length of the mattress toward the top of the access panel openings. The temperature of this air curtain is
higher than the typical incubator air temperature; therefore, keep the infant clear of this
warm air path.
For proper operation of the incubator, use
only skin temperature probes from Dräger.
WARNING
Risk of death or serious injury
If using surgical covers or blankets over the
infant, ensure that they do not interfere with
the warm air curtain or side vents. This may
cause heat-induced injury and burns.
WARNING
Risk of death or serious injury
To avoid overheating the infant due to direct
radiation, do not position the incubator in
direct sunlight or under other sources of radiant heat.
WARNING
Risk of death or serious injury
Use of phototherapy devices with the incubator may affect hood wall temperature, incubator temperature, and infant skin temperature.
WARNING
Risk of death or serious injury
Never place objects taller than the top of the
castor wheels beneath the incubator stand.
Placement of objects there could interfere
with the stability of the stand.
WARNING
Risk of death or serious injury
Always use 2 people when moving the incubator and patient together. When moving the
incubator within the same floor space:
– Check that the patient is secured safely in
the device
– Remove or secure all loose system components
– Lower the VHA stand, I.V. pole, and
shelves to their lowest position
– Close all drawers
– Remove all accessories from the rails
WARNING
Risk of death or serious injury
WARNING
Risk of death or serious injury
For optimum stability, always lower the incubator to its lowest position before moving the
device. Make sure that items placed on the
monitor shelf are properly secured.
Phototherapy lights placed over the top of the
incubator hood may interfere with upward
travel of the VHA stand.
WARNING
Risk of death or serious injury
To prevent this interference, always remove
the phototherapy light before positioning the
stand.
Lateral or angular movement (across the
width) can result in inadvertent tip-over if the
wheels encounter any obstacle.
Always push or pull the incubator forward or
backward in a straight line along the length of
the stand (from the ends).
16
Instructions for Use Isolette 8000
Page 17
For your safety and that of your patients
WARNING
Risk of death or serious injury
WARNING
Risk of death or serious injury
To avoid possible tip-over or damage to adjacent carts, infusion stands, shelves, etc., keep
at least a 30 cm (12 in) perimeter area clear
around the stand.
Do not insert any object into any of the ventilation holes or any other opening on the Isolette 8000.
WARNING
Risk of death or serious injury
For optimum incubator stability, always lock
all stand wheels. Do not leave the device unattended when parking on an incline.
WARNING
Risk of death or serious injury
To prevent accidental disconnection, secure
all patient leads, infusion lines, and ventilator
tubing to the mattress with sufficient excess
length to allow for the full range of mattress
height adjustment.
WARNING
Risk of death or serious injury
Accessories such as trays, baskets, and
shelves should never be used to hold an
infant and should not be overloaded due to
tip-over hazard.
WARNING
Risk of death or serious injury
Always close drawers when not in use, particularly when the incubator is being moved.
WARNING
Risk of death or serious injury
The drawers and rail system are labeled for
acceptable weights. Do not exceed these
weight limitations.
Instructions for Use Isolette 8000
WARNING
Risk of death or serious injury
To prevent possible trip and fall hazards,
always properly secure the power cable.
WARNING
Risk of death or serious injury
Before moving the device, always ensure that
the mattress is level, i.e., not in the Trendelenburg or Reverse Trendelenburg position.
WARNING
Risk of death or serious injury
To place the bed in Trendelenburg or Reverse
Trendelenburg, always tilt one end of the bed
and keep the opposite end in the lowest position. Elevating both ends simultaneously is
not recommended.
WARNING
Risk of death or serious injury
Before placing the bed in Trendelenburg or
Reverse Trendelenburg, ensure that patient
extremities are not caught between the bed
and the hood walls.
WARNING
Risk of death or serious injury
Use caution when opening doors fitted with
tubing grommets so that patient lines or
cables do not become accidentally disconnected.
17
Page 18
For your safety and that of your patients
CAUTION
Risk of injury or equipment damage.
Do not connect the Isolette 8000 to a surge suppressor.
18
Instructions for Use Isolette 8000
Page 19
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Environment of use . . . . . . . . . . . . . . . . . . . . 20
Indications/contraindications . . . . . . . . . . . . 20
Instructions for Use Isolette 8000
19
Page 20
Application
Intended use
The Isolette 8000 infant incubator provides a controlled environment for both premature and fullterm babies up to a maximum of 10 kg (22 lb). It
controls temperature, oxygen (optional), and
humidity (optional).
Environment of use
The Isolette 8000 infant incubator can be used in
any department of the hospital that provides neonatal and infant care, including all levels of the Neona-
tal Intensive Care Unit (NICU), Special Baby Care
Unit, Step Down Nursery, Newborn Nursery, and
Pediatrics.
Indications/contraindications
The Isolette 8000 infant incubator is indicated for
thermoregulation and controlling oxygen (optional)
and humidity (optional).
The Isolette 8000 infant incubator is not intended
for home use.
20
Instructions for Use Isolette 8000
Page 21
Overview
Overview
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Rear view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Right side view . . . . . . . . . . . . . . . . . . . . . . . . 24
Left side view . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sensor module . . . . . . . . . . . . . . . . . . . . . . . . 26
Isolette 8000 overview . . . . . . . . . . . . . . . . . . 27
Oxygen system . . . . . . . . . . . . . . . . . . . . . . . . 27
Servo oxygen control system (option) . . . . . . . 27
Manual oxygen control system (option) . . . . . . 27
Humidity system (option) . . . . . . . . . . . . . . . 28
Humidity reservoir assembly . . . . . . . . . . . . . . 28
Evaporator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Heater/impeller cover with duct cover . . . . . . . 28
Condensation management system
(option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Weighing system (accessory) . . . . . . . . . . . . 29
Non-OIML/NAWI scales . . . . . . . . . . . . . . . . . . 29
OIML/NAWI scales . . . . . . . . . . . . . . . . . . . . . . 29
Functional description . . . . . . . . . . . . . . . . . . 29
Air circulation system . . . . . . . . . . . . . . . . . . . . 29
Temperature regulation. . . . . . . . . . . . . . . . . . . 29
External devices . . . . . . . . . . . . . . . . . . . . . . . 30
Convenience outlets . . . . . . . . . . . . . . . . . . . 31
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 32
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Technical definitions . . . . . . . . . . . . . . . . . . . 35
Instructions for Use Isolette 8000
21
Page 22
Overview
Front view
B
A
Q
C
D
E
F
P
O
G
N
H
I
M
J
K
000
L
A Hood
J
B Locking knob
K VHA controls
C I.V. pole (optional)
L Castor wheels (with brakes)
D Hand port
M Drawers (optional)
E Access panel
N Incubator AC power cable receptacle
F Screen
O Humidity reservoir (optional)
G Front panel of controller
P Trendelenburg bed-tilt knob
H Serial port
Q Monitor shelf (optional)
I
22
Stand with variable height adjustment (VHA)
Incubator On/Off switch
Instructions for Use Isolette 8000
Page 23
Overview
Rear view
A
G
B
F
E
C
001
D
A Incubator type plate
B Oxygen inlet
C VHA stand type plate
D Steering castor wheel
E Cable wrap
F Cylinder mount (optional)
G Air intake filter
Instructions for Use Isolette 8000
23
Page 24
Overview
Right side view
A
B
F
C
D
017
E
A Sensor module
B Oval hand port (or optional iris port)
C Hood release knob
D Controller/sensor module interface connector
E Accessory rail/handle
F Tubing grommets
24
Instructions for Use Isolette 8000
Page 25
Overview
Left side view
G
F
A
E
B
C
061
D
A Convenience outlets
B AC power cable receptacle
C Main On/Off switch
D Fuse holder
E Condensation management collection bottle
(optional)
F Condensation management bracket (optional)
G Condensation management hose (optional)
Instructions for Use Isolette 8000
25