TI500 Instructions for Use Edition 1 Sept 2018.pdf
Page 1
Instructions for Use
TI500
WARNING
To properly use this medical device,
read and comply with these instructions for use.
Neonatal Transport 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, Set Temp, Air Flow, or Audio Paused/Reset.
Screen images
Schematic renderings of screen images are used,
which may differ in appearance or in configuration
from the actual screen images.
A Letters in illustrations denote elements referred
to in the text.
Trademarks
Trademark
Trademark owner
TM
Care-for-Me
Globe-Trotter
SoftBed
Ferno®
TM
®
Dräger
Dräger
Dräger
Ferno-Washington, Inc
Trademark
CaviCide®
Dismozon®pur
EnerSys®
Genesis®
Trademark owner
Metrex Research Corporation
Bode Chemie GmbH
EnerSys and affiliates
EnerSys and affiliates
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 TI500 Neonatal Transport Incubator
Page 3
Definition of target groups
For this product, users and service personnel 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, or maintain the medical device.
The product must be used, installed, reprocessed,
or maintained 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.
Instructions for Use TI500 Neonatal Transport Incubator
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Instructions for Use TI500 Neonatal Transport Incubator
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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
Product-specific safety information. . . . . . . . . . 12
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Environment of use. . . . . . . . . . . . . . . . . . . . . . 18
Indications/contraindications . . . . . . . . . . . . . . 18
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Left side view . . . . . . . . . . . . . . . . . . . . . . . . . .
Power chassis . . . . . . . . . . . . . . . . . . . . . . . . .
TI500 neonatal transport incubator overview . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Technical definitions . . . . . . . . . . . . . . . . . . . . .
20
21
22
23
24
25
26
27
Operating concept . . . . . . . . . . . . . . . . . . . . . 29
TI500 controller. . . . . . . . . . . . . . . . . . . . . . . . . 30
Assembly and preparation . . . . . . . . . . . . . . 33
Assembly safety information . . . . . . . . . . . . . .
Unpackaging. . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the battery . . . . . . . . . . . . . . . . . . .
Attaching the incubator to the trolley . . . . . . . .
Installing the gas cylinders . . . . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
34
34
35
35
39
39
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 41
System start-up . . . . . . . . . . . . . . . . . . . . . . . . 42
TI500 operational checkout procedure . . . . . . . 43
Operational checkout procedure for the
trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Instructions for Use TI500 Neonatal Transport Incubator
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
49
Routine operation . . . . . . . . . . . . . . . . . . . . . . 50
Pre-warm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Auto-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Setting the temperature. . . . . . . . . . . . . . . . . . 52
Infant placement . . . . . . . . . . . . . . . . . . . . . . . 52
Placement of the skin temperature sensor . . . 53
Humidity usage . . . . . . . . . . . . . . . . . . . . . . . . 54
Variable height adjustment of the trolley . . . . 54
Examination light operation . . . . . . . . . . . . . . . 56
Power source usage . . . . . . . . . . . . . . . . . . . . 56
Infant transport . . . . . . . . . . . . . . . . . . . . . . . . 56
Accessory shelf usage . . . . . . . . . . . . . . . . . . 57
System shut-down. . . . . . . . . . . . . . . . . . . . . . 58
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
59
Safety information . . . . . . . . . . . . . . . . . . . . . .
Alarm priority definitions . . . . . . . . . . . . . . . . .
Alarm indication. . . . . . . . . . . . . . . . . . . . . . . .
Silencing alarms . . . . . . . . . . . . . . . . . . . . . . .
60
60
61
61
Problem solving . . . . . . . . . . . . . . . . . . . . . .
63
Alarm messages . . . . . . . . . . . . . . . . . . . . . . .
Other problems . . . . . . . . . . . . . . . . . . . . . . . .
64
66
Cleaning and disinfection. . . . . . . . . . . . . . .
67
Safety information . . . . . . . . . . . . . . . . . . . . . .
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . .
Reprocessing procedures . . . . . . . . . . . . . . .
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . .
Reassembly after cleaning . . . . . . . . . . . . . . .
68
69
70
74
76
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . .
79
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preventive maintenance . . . . . . . . . . . . . . . . .
Maintenance instructions. . . . . . . . . . . . . . . . .
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
80
81
82
84
88
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
89
Disposal of the Medical Device . . . . . . . . . . . .
90
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Contents
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 91
TI500 system specifications . . . . . . . . . . . . . . . 92
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 95
List of accessories . . . . . . . . . . . . . . . . . . . . . 97
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
6
Instructions for Use TI500 Neonatal Transport Incubator
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For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . . . .
Strictly follow these instructions for use . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection to other devices . . . . . . . . . . . . . . .
Functional safety . . . . . . . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic compatibility (EMC) . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
Restrictions for use. . . . . . . . . . . . . . . . . . . . . .
8
8
8
8
8
9
9
9
9
10
10
10
11
11
11
12
12
Product-specific safety information . . . . . . . 12
Electrical precautions . . . . . . . . . . . . . . . . . . . .
Explosion precautions . . . . . . . . . . . . . . . . . . .
EMC precautions . . . . . . . . . . . . . . . . . . . . . . .
Oxygen precautions . . . . . . . . . . . . . . . . . . . . .
System precautions . . . . . . . . . . . . . . . . . . . . .
12
12
13
13
14
Instructions for Use TI500 Neonatal Transport Incubator
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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
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 18 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
The medical device must be inspected and
serviced regularly by professionals who possess the required qualifications due to their
training and their experience. Repair of the
medical device must also be performed by
trained personnel with additional productspecific DrägerService training.
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService.
Dräger further recommends that only authentic Dräger repair parts are used for maintenance.
If the above are not complied with, the correct
functioning of the medical device may be
compromised.
See chapter "Maintenance".
Safety checks
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Accessories
WARNING
Risk 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 TI500 Neonatal Transport Incubator
Page 9
For your safety and that of your patients
WARNING
Risk of equipment damage and risk of injury
Safe connection with other electrical
equipment
Reusing, reprocessing, or sterilizing disposable items can lead to a failure of the medical
device and cause injury to the patient.
CAUTION
Risk of patient injury
Do not reuse, reprocess, or sterilize disposable items. Disposable items were designed,
tested, and manufactured for single-use only.
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.
WARNING
Risk of equipment damage and risk of injury
Do not use single-use packaged accessories
if the package has been compromised.
Connected devices
WARNING
Risk of electric shock and of device malfunction
Any connected devices or device combinations not complying with the requirements
mentioned in these Instructions for Use may
compromise the correct functioning of the
medical device. Before operating any combination of devices, refer to and strictly comply
with the Instructions for Use for all connected
devices and device combinations.
Not for use in areas of explosion hazard
Connection to other devices
Device combinations approved by Dräger (see
Instructions for Use of the individual devices) meet
the requirements of the following standards:
– IEC 60601-1:2005
Medical electrical equipment
Part 1: General requirements for basic safety
and essential performance
– IEC 60601-1-2:2007
Medical electrical equipment
Collateral standard: electromagnetic compatibility, requirements and tests
If Dräger devices are connected to other Dräger
devices or third-party devices and the resulting
combination is not approved by Dräger, the correct
functioning of the devices may be compromised.
The owner is responsible for ensuring that the
resulting system meets the requirements of the
applicable standards.
Strictly observe Assembly Instructions and Instructions for Use for each networked device.
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
Instructions for Use TI500 Neonatal Transport Incubator
9
Page 10
For your safety and that of your patients
Functional safety
Patient safety
The essential performance consists of:
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.
–
Air temperature regulation
The air temperature setting (target value) is
compared to the actual ambient air temperature
and is regulated.
If any of the regulating actions are not possible, an
alarm is generated.
The medical device is equipped with basic safety
features to reduce the possibility of patient injury
while the cause of an alarm is remedied.
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:
WARNING
–
Risks that are obvious to users
Risk of malfunction
–
Unauthorized modifications to the medical
device may lead to malfunctions.
Consequences of obvious improper use of the
medical device
–
Potentially negative effects on patients with different underlying diseases
This medical device must not be modified
without the permission of Dräger.
WARNING
Risk of reduced safety level
Connecting electrical equipment to a power
socket strip effectively leads to creating a
medical electrical system. The result can be a
reduced level of safety.
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.
Comply with the requirements of IEC 60601-1
when constructing a medical electrical
system.
Patient monitoring
WARNING
Risk of malfunction
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.
Low battery charge can cause the system to
shut down prematurely.
Always verify the battery life at the recommended time periods listed in the battery
maintenance section. Replace the battery if it
either fails to meet the performance specification or meets the recommended replacement
period.
10
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.
Instructions for Use TI500 Neonatal Transport Incubator
Page 11
For your safety and that of your patients
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special
precautionary measures concerning electromagnetic compatibility. During installation and before
initial operation, follow the information in section:
"EMC Declaration" (page 95).
This device can be affected by other electrical
devices.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against electrostatic discharge are employed in the following situations:
– When touching the pins of connectors that
carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the following measures and train the relevant personnel:
– Observe the ESD protective measures.
Such measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and while
making the connection, or using electrically insulating and antistatic gloves.
– Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic environment" (page 95).
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g., cellular phones) and medical electrical equipment
(e.g., defibrillators, electrosurgical devices)
emit electromagnetic radiation. When such
devices are operated too close to this device
or its cables, the functional integrity of this
device may be compromised by electromagnetic disturbances. As a result, the patient
could be put at risk.
Maintain a distance of at least 0.3 m (1.0 ft)
between this device and wireless communication devices, to ensure that the essential performance of this device is fulfilled.
Maintain an adequate distance between this
device and other medical electrical equipment.
Do not use in an MRI environment.
Installing accessories
CAUTION
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 system.
Strictly observe assembly instructions and instructions for use.
Training
Training for users is available from the Dräger organization responsible, see www.draeger.com.
Instructions for Use TI500 Neonatal Transport Incubator
11
Page 12
For your safety and that of your patients
Storing the instructions for use
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.
Restrictions for use
CAUTION
Device for use in health care 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.
Product-specific safety information
Electrical precautions
WARNING
The potential for electrical shock exists with
electrical equipment. Establish policies and
procedures to educate your staff on the risks
associated with electrical equipment. Noncompliance may result in death or serious
injury.
WARNING
To ensure grounding reliability, plug the AC
power cable only into a properly grounded
(properly earthed), 3-wire hospital-grade or
hospital-use socket. Do not use extension
cables. If any doubt exists as to the grounding
connection, do not operate the equipment.
Noncompliance may result in death or serious
injury.
WARNING
When any of the electronics covers are
removed, an electrical shock hazard exists.
Servicing should be performed by trained
technical personnel. Noncompliance may
result in death or serious injury.
12
WARNING
Do not reset a circuit breaker without assessing and correcting what caused the breaker or
fuse to activate. Noncompliance may result in
death or serious injury.
WARNING
Unplug the power cable from its power source
before performing any service or cleaning the
system. Noncompliance may result in death or
serious injury.
WARNING
Do not expose the device to excessive moisture. Personal injury or equipment damage
could occur. Noncompliance may result in
death or serious injury.
Explosion precautions
WARNING
The TI500 is not suitable for use in the presence of flammable anesthetic gases or other
flammable materials, such as certain types of
cleaning fluids. Noncompliance may result in
death or serious injury.
Instructions for Use TI500 Neonatal Transport Incubator
Page 13
For your safety and that of your patients
WARNING
Before performing electrical service procedures or changing any battery, shut off the O2
cylinders. Noncompliance may result in death
or serious injury.
WARNING
Before cleaning or maintenance, switch off all
gas sources, and bleed off remaining pressure. When performing cleaning or maintenance procedures in an oxygen-enriched
environment, a fire and explosion hazard
exists. Noncompliance may result in death or
serious injury.
WARNING
Small quantities of flammable agents (such as
ethyls and alcohol) left in the incubator may
cause a fire in connection with oxygen. This
may result in death or serious injury.
EMC precautions
WARNING
Use of accessories other than those listed and
approved for use with this product, either as
original or replacements items may result in
increased emissions or decreased immunity
of the equipment. Noncompliance may result
in death or serious injury.
WARNING
The equipment should not be used adjacent to
or stacked with other equipment unless verification of normal operation in the configuration in which it is to be used can be achieved.
Noncompliance may result in death or serious
injury.
Instructions for Use TI500 Neonatal Transport Incubator
Oxygen precautions
WARNING
Improper use of supplemental oxygen can
cause serious side effects, including blindness, brain damage, and death. The risks vary
with each infant. The attending physician prescribes the method, concentration, and duration of oxygen administration.
Noncompliance may result in death or serious
injury.
WARNING
The oxygen concentration inspired by an
infant does not accurately determine the partial pressure of oxygen (PaO2) in the blood.
The PaO2 should be measured by an accepted
clinical technique when advised by the attending physician. Failure to do so could result in
personal injury or equipment damage.
WARNING
If it is necessary to administer oxygen in an
emergency, notify the attending physician
immediately. Noncompliance may result in
death or serious injury.
WARNING
Oxygen administration may increase the
noise level for the infant within the patient
compartment. Noncompliance may result in
death or serious injury.
WARNING
Oxygen flow rates cannot be used as an accurate indication of oxygen concentration in an
incubator. Oxygen concentrations must be
continuously monitored with a calibrated oxygen analyzer at intervals directed by the
attending physician. If an oxygen analyzer is
not part of the system, then the caregiver must
provide an independent analyzer when oxygen is administered. Noncompliance may
result in death or serious injury.
13
Page 14
For your safety and that of your patients
WARNING
Keep matches, lit cigarettes, and all other
sources of ignition out of the area in which
oxygen is in use. Textiles, oils, and other combustibles are easily ignited, and burn with
great intensity in oxygen-enriched air. Prominently display “NO SMOKING” signs. Do not
place auxiliary equipment that produces
sparks within or near the incubator. Noncompliance may result in death or serious injury.
WARNING
On high-pressure O2 cylinders, use only
approved reducing or regulating valves
marked for oxygen service. Do not use these
valves for air or gases other than oxygen
since they could be hazardous when returned
to oxygen service. Operate such equipment
strictly according to the directions of the valve
manufacturer. Noncompliance may result in
death or serious injury.
WARNING
Although oxygen-compatible materials are
used in the oxygen delivery system, take special care when high-pressure oxygen, such as
found in a medical O2 cylinder, is used. If their
ignition temperature is reached, violent ignition of oil, grease, greasy substances, small
particles or dust, dirt, or other particulate contaminants, even small particles of metal, could
occur in the presence of high-pressure oxygen. If the O2 cylinder valve is opened too rapidly, an instantaneous increase in temperature
could occur due to friction, particle acceleration, or adiabatic compression. This may
result in death or serious injury.
WARNING
Keep oil, grease, greasy substances, dust,
dirt, and other particulate contaminants away
from oxygen regulators, cylinder valves, tubing, and all other oxygen equipment. Noncompliance may result in death or serious injury.
14
System precautions
WARNING
Incubator misuse may result in harm to an
infant. Only properly trained personnel should
use the incubator as directed by an appropriately qualified physician aware of currently
known hazards and benefits. Noncompliance
may result in death or serious injury.
WARNING
The incubator is equipped with a High Temperature alarm, but it is activated only by the
air temperature. Thermal radiation from sunlight or other sources can cause temperature
increase within the hood and can cause overheating of the infant without triggering the
alarm. Do not permit extended exposure of the
incubator to direct sunlight or other sources
of thermal radiation. Noncompliance may
result in death or serious injury.
WARNING
For infant safety, do not leave infant unattended when hand ports are open. The infant
could fall which may result in death or serious
injury.
WARNING
For infant safety, do not leave the access panels open longer than essential. The air temperature indicator does not accurately reflect
the incubator temperature when the access
panels are open. Under these conditions, the
incubator temperature may be significantly
lower than the displayed temperature. Noncompliance may result in death or serious
injury.
WARNING
Perform the auto test sequence before each
use to be certain that all control and alarm
indicators are functional. Do not use if the test
sequence does not perform as specified. Noncompliance may result in death or serious
injury.
Instructions for Use TI500 Neonatal Transport Incubator
Page 15
For your safety and that of your patients
WARNING
Before using the optional trolley with variable
height adjustment (VHA), read the Instructions for Use. Noncompliance may result in
death or serious injury.
WARNING
To prevent inadvertent tip-over of the incubator during transport in the trolley's high position, do not exceed the 6.8 kg (15 lb) load limit
of the optional accessory shelf. If only one
oxygen cylinder is used, mount it in the compartment under the controller. Always push or
pull the incubator forward or backward in a
straight line along the length of the trolley
(from the ends). Lateral or angular movement
(across the width) can result in inadvertent tipover if the wheels encounter any obstacle.
Noncompliance may result in death or serious
injury.
Instructions for Use TI500 Neonatal Transport Incubator
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Instructions for Use TI500 Neonatal Transport Incubator
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Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Environment of use . . . . . . . . . . . . . . . . . . . . 18
Indications/contraindications . . . . . . . . . . . . 18
Instructions for Use TI500 Neonatal Transport Incubator
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Page 18
Application
Intended use
The TI500 neonatal transport incubator is intended
for the transport of high risk, premature, low birth
weight, or critically ill newborns. It provides a
means to control air temperature, control oxygen,
and add relative humidity. The device is designed
for use with patients weighing up to a maximum of
10 kg (22 lb).
Environment of use
The TI500 neonatal transport incubator can be
used in any department of the hospital that provides
neonatal and infant care, including all levels of the
Neonatal Intensive Care Unit (NICU), Special Baby
Care Unit, Step Down Nursery, Newborn Nursery,
and Pediatrics. It can also be used in transport vehicles between hospitals.
Indications/contraindications
The TI500 neonatal transport incubator is indicated
for thermoregulation and controlling oxygen
(optional) and humidity (optional).
The TI500 neonatal transport incubator is not
intended for home use.
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Instructions for Use TI500 Neonatal Transport Incubator
Page 19
Overview
Overview
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Rear view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Left side view . . . . . . . . . . . . . . . . . . . . . . . . . 22
Power chassis. . . . . . . . . . . . . . . . . . . . . . . . . 23
TI500 neonatal transport incubator
overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Functional description. . . . . . . . . . . . . . . . . . . . 24
Temperature control . . . . . . . . . . . . . . . . . . . . . 24
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 25
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Technical definitions . . . . . . . . . . . . . . . . . . . 27
Instructions for Use TI500 Neonatal Transport Incubator
19
Page 20
Overview
Front view
A
B
C
D
E
F
G
H
N
I
M
L
K
000
J
A Hood
I
Controller
B Accessory shelf (optional)
J
Trolley (optional) with variable height adjustment (VHA)
C Hand port
D Hand port latch
E Front access panel
F Access panel locking knob
G I.V. pole (optional)
K Gas cylinder holder
L Gas cylinder retaining clamp
M Guard rail
N Hood latch
H Tubing grommet
20
Instructions for Use TI500 Neonatal Transport Incubator
Page 21
Overview
Rear view
A
B
001
C
A Examination light
B Air intake filter
C Device type label
Instructions for Use TI500 Neonatal Transport Incubator
21
Page 22
Overview
Left side view
B
A
C
F
E
D
A Head-end access panel
B Iris port
C Access panel locking knob
D Gas cylinder holder
E Power chassis
F Tubing grommets
22
Instructions for Use TI500 Neonatal Transport Incubator
002
0
Page 23
Overview
Power chassis
B
A
C
0
D
G
F
003
H
E
A Main AC On/Off switch
B Skin temperature sensor receptacle
C External DC power socket
D ( – ) Negative voltage
E ( + ) Positive voltage
F No connection
G Circuit breakers
H IEC power inlet
Instructions for Use TI500 Neonatal Transport Incubator
23
Page 24
Overview
TI500 neonatal transport incubator overview
The TI500 neonatal transport incubator provides
transport of high risk, premature, low birth weight,
or critically ill newborns.The transport incubator
provides a means to control air temperature, provide oxygen, and add relative humidity. A doublewalled hood permits full visibility and provides an
effective thermal and sound barrier from the environment. Access panels, hand ports, and an iris
port provide front and head access. The bed slides
out of the head (left) end for additional access to the
newborn. There are tubing grommets on both sides
of the front access panel and on the head-end
access panel. Gas cylinder holders are provided for
two E or D-size cylinders. An examination light is
also included.
The incubator is designed to operate from either a
sine or square wave AC power source. In addition,
the incubator can operate from an external
12 V DC or 28 V DC source or integral 12 V DC
batteries. Whenever the device is connected to an
AC voltage source and the mains switch is set to
the ON-1 position, the batteries automatically
charge.
A comprehensive visual and audible fault alarm
system, with a test function to verify proper alarm
operation, is included along with a Battery status
indicator.
The incubator mounts to an optional trolley with
variable height adjustment (VHA). Other optional
features include a high hood, second battery, pressure regulator and flowmeter, I.V. pole, and accessory shelf.
The TI500 incubator is also used with the GlobeTrotter GT500 and the Globe-Trotter IC neonatal
transport systems.
24
Functional description
A forced air circulation system controls temperature
and humidity. A motor-driven impeller draws a controlled amount of room air through the air intake filter.
In addition to drawing fresh, filtered air into the incubator, the impeller recirculates at a much greater
flow than that of the fresh gas inflow. The air is
directed over the humidity chamber. If humidification is required, the optional humidity pad should be
wetted and placed in the humidity chamber. When
the access panel of the hood is closed, the air
enters the patient compartment up through the slots
at the right end of the patient compartment. After
circulating within the patient compartment, the air is
then circulated down the left end of the compartment, past the temperature sensor, and back to the
impeller.
The transport incubator is designed to operate from
one of three power sources. The three sources are
used in the following order: If external AC power is
not available, the incubator switches to external DC
power. If external DC power is not available, it
switches to its internal batteries.
The batteries can be charged only when the device
is operating from an AC source.
Temperature control
A temperature sensor, located in the recirculation
air path, and a proportional control circuit, which
determines the heater output required to maintain
the desired incubator temperature, regulate the
incubator temperature. The Heater indicator on the
controller indicates the relative amount of heat provided.
Instructions for Use TI500 Neonatal Transport Incubator
Page 25
Overview
The incubator temperature can be maintained from
21.5 °C (70.7 °F) to 38 °C (100.4 °F), as selected
with the temperature controls on the controller. The
temperature, as sensed by a sensor located within
the housing, is compared to the setpoint. Control
circuitry, which proportions the heater output to
maintain the setpoint, supplies the information from
this sensor. The temperature is displayed on the
controller. The setpoint is preset to 36 °C (96.8 °F)
± 0.15 °C, and, unless the setpoint is changed, the
incubator heats to this temperature. The Set Temp
controls on the controller can change the setpoint
to a prescribed temperature (see page 30). An
additional sensor within the housing serves as a
backup to limit the incubator maximum air temperature to 39 °C (102.2 °F) ± 0.5 °C. At this limit, the
High Temp alarm activates, and the heater shuts
off.
Abbreviations
Abbreviation Meaning
AC
alternating current
DC
direct current
EMC
electromagnetic compatibility
EN
European norm
ESD
electrostatic discharge
GMDN
Global Medical Device Nomenclature
IEC
International Electrotechnical Commission
I.V.
intravenous
LED
light-emitting diode
PaO2
partial pressure of oxygen in the
blood
RH
relative humidity
UMDNS
Universal Medical Device Nomenclature System
VHA
variable height adjustment
Instructions for Use TI500 Neonatal Transport Incubator
25