Drager TI-500 User manual

Transport Incubator

WARNING:

For a full understanding of the performance
characteristics of this equipment, the user
should carefully read this manual before
operating.

Operating Instructions
Model TI500

Table of Contents

Section 1: Symbol Definition and Intended Use

Symbol Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Technical Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Section 2: Introduction, Features, and Specifications

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Temperature Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Optional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . 2-7

Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Temperature Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Regulations, Standards, and Codes . . . . . . . . . . . . . . . . . . . 2-9

Section 3: Precautions and Safety Tips

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Electrical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Explosion Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Oxygen Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Electromagnetic Compatibility Precautions. . . . . . . . . . . . . 3-5

Section 4: Installation and Assembly

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Connection to External Power Sources . . . . . . . . . . . . . . . . 4-5

Installation of Oxygen Cylinders . . . . . . . . . . . . . . . . . . . . . 4-6

Transport Incubator (Model TI500) User Manual (67 990 70) Page i

General Operation and Functional Checkout . . . . . . . . . . . .4-7

Section 5: Instructions for Use

Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Controls, Indicators, and Connectors . . . . . . . . . . . . . . . . . .5-1

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

General Operation and Functional Checkout

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

Operation During Use . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-25

Adjustable Stand (Optional) . . . . . . . . . . . . . . . . . . . .5-25

Shelf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-26

Shelf Tie-Down Strap . . . . . . . . . . . . . . . . . . . . . . . . .5-26

Section 6: Cleaning, Maintenance, and Replacement Parts

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

General Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Steam Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Cleaning Hard to Clean Spots. . . . . . . . . . . . . . . . . . . . . . . 6-2

Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2

Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

Disassembling for Cleaning . . . . . . . . . . . . . . . . . . . . . . . . .6-3

Access Panel Cuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

Mattress Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Hood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Upper Shell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4

Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Lower Shell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5

Humidity Chamber and Upper Shell . . . . . . . . . . . . . .6-5

Mattress Tray and Deck. . . . . . . . . . . . . . . . . . . . . . . . 6-6

Hood and Accessory Adjustable Stand . . . . . . . . . . . . .6-6

Tubing Access Grommets . . . . . . . . . . . . . . . . . . . . . . .6-7

Page ii Transport Incubator (Model TI500) User Manual (67 990 70)

Air Intake Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Skin Temperature Probe . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Assembling After Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Power Failure Alarm Battery . . . . . . . . . . . . . . . . . . . . . . 6-12

Calibration and Preventive Maintenance . . . . . . . . . . . . . 6-13

Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

Section 7: Troubleshooting

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Section 8: Storage and Handling

Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Transport Incubator (Model TI500) User Manual (67 990 70) Page iii

Page iv Transport Incubator (Model TI500) User Manual (67 990 70)

Section 1

Symbol Definition

and Intended Use

Symbol Definition

This manual contains different typefaces and icons designed to improve
readability and increase understanding of its content. Note the following
examples:

• Standard text—used for regular information.

• Boldface text—emphasizes a word or phrase.

• NOTE:—sets apart special information or important instruction
clarification.

• The symbol below highlights a WARNING or CAUTION:

Warning and Caution

– A WARNING identifies situations or actions that may affect

patient or user safety. Disregarding a warning could result in
patient or user injury.

– A CAUTION points out special procedures or precautions that

personnel must follow to avoid equipment damage.

• The symbol below highlights a CAUGHT HAZARD WARNING:

Caught Hazard Warning

SYMBOL DEFINITION

INTENDED USE

• The symbol below highlights a CHEMICAL HAZARD WARNING:

Chemical Hazard Warning

• The symbol below highlights an ELECTRICAL SHOCK HAZARD
WA RN IN G :

Electrical Shock Hazard Warning

Transport Incubator (Model TI500) User Manual (67 990 70) Page 1 - 1

This product contains different icons designed to increase
understanding. Note the following examples:

• The symbol below indicates “Attention! Consult accompanying
documents”:

Attention! Consult Accompanying Documents

• The symbol below indicates “Type BF equipment with an F-type
isolated (floating) applied part”:

Type BF Equipment

• The symbol below indicates a BATTERY OPERATION
INDICATOR:

Battery Operation Indicator

• The symbol below indicates a POWER ON/OFF SWITCH:

Power On/Off Switch

• The symbol below indicates a SET TEMPERATURE DOWN KEY:

Set Temperature Down Key

• The symbol below indicates a SET TEMPERATURE UP KEY:

Set Temperature Up Key

Page 1 - 2 Transport Incubator (Model TI500) User Manual (67 990 70)

• The symbol below indicates a SILENCE/RESET KEY:

Silence/Reset Key

• The symbol below indicates “Electromagnetic interference:”

Electromagnetic Interference

Technical Definitions

• Setpoint—The incubator temperature selected for operation during
use.

• Incubator temperature—Air temperature at a point 10 cm (4")
above and centered over the mattress surface.

• Temperature equilibrium—The condition reached when the
average incubator temperature does not vary more than 0.2°C
(0.36°F) over a period of one hour.

• Temperature overshoot—The amount by which the incubator
temperature exceeds the average incubator temperature at
temperature equilibrium when the setpoint is changed from 30°C
(86°F) to 34°C (93.2°F).

SYMBOL DEFINITION

INTENDED USE

• Temperature rise time—The time required for the incubator
temperature to rise to 34°C (93°F) from an ambient temperature of
23°C (73.4°F) with a 36°C (96.8°F) setpoint.

• Temperature uniformity—The amount by which the average
temperature at each of five points 10 cm (4") above the mattress
surface differs from the average incubator temperature at temperature
equilibrium. (The five points are the centers of five areas created by
lines that divide the width and length of the mattress surface.)

• Temperature variability—During steady temperature conditions,
the incubator temperature (measured 10cm above center mattress) is
within 1°C of the average incubator temperature.

Transport Incubator (Model TI500) User Manual (67 990 70) Page 1 - 3

Intended Use

This manual provides instructions for installation, use, operator
maintenance, and troubleshooting of the transport incubator (Model
TI500).

Dräger Medical cannot be responsible for the performance and safety of
the incubator if the user does not operate the unit in accordance with the
instructions, fails to follow the maintenance recommendations, or
makes any repairs with unauthorized components. Only qualified
service personnel should perform calibration and repair. Additional
technical information is available from the manufacturer upon request
through your local distributor.

All personnel who will be working with the unit should read, thoroughly
understand, and have ready access to this manual. Store the manual with
the incubator when not in use. If there is anything you do not
understand, please contact your local representative for further
information.

Page 1 - 4 Transport Incubator (Model TI500) User Manual (67 990 70)

Section 2

Introduction, Features,

and Specifications

Introduction

The transport incubator provides transport of high-risk, premature, low
birth-weight, or critically ill newborns. It provides a means to control air
temperature, oxygen concentrations, and relative humidity. A double­walled hood permits full visibility and provides an effective thermal and
sound barrier from the environment. Arm ports and door panels provide
front and head access, and the mattress tray slides out of the head end
for additional access to the newborn. Tubing access grommets are on
both sides of the front access panel and at the head end (left) panel. An
observation lamp 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 12V DC or 28V DC source or integral 12V DC batteries.
Whenever the unit is connected to an AC voltage source and the main
Power 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.

SPECIFICATIONS

INTRODUCTION

FEATURES

System Overview

A forced air circulating system controls temperature, humidity, and
oxygen concentration. A motor-driven impeller draws a controlled
amount of room air through the air/oxygen intake filter. Supplemental
oxygen, introduced through the oxygen inlet connector on the left side
of the unit (when viewed from the front of the unit), displaces a portion
of room air to maintain the total gas intake (including oxygen) at the
same level. Since the impeller/filter controls the amount of room air and
the flow meter setting controls the amount of oxygen, a predictable
oxygen concentration within the incubator can be attained.

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 sponge for humidification, when used.
When the access panel of the hood is closed, the air enters the infant

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 1

compartment up through the slots at the right end of the housing. After
circulating within the infant compartment, the air is then circulated
down the left end of the housing, past the temperature sensing probe,
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 is not available, the incubator switches to external DC. If that is not
available, it switches to its internal batteries.

The batteries can be charged only when the unit 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 number of Heater indicators lit on the control panel
indicate the relative amount of heat provided.

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 control
panel. 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 front
panel. The setpoint is preset to 36°C (96.8°F) ± 0.15°C, and, unless the
setting is changed, the incubator heats to this temperature. The Set
Temp controls on the control panel can change the setpoint to a
prescribed temperature (see “Operation During Use” on page 5-16). 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 Temperature alarm activates, and the heater shuts off.

Alarms

Each time the unit turns on, it automatically activates a test sequence to
verify that the visual display and audible alarms are functional.

• High Temperature—A sensor located below the deck sounds this
alarm when the incubator temperature is equal to or greater than
39°C (102.2°F) ± 0.5°C. A flashing High Temp indicator and a tone

Page 2 - 2 Transport Incubator (Model TI500) User Manual (67 990 70)

indicate a High Temperature alarm. Internally, the heater turns off.
To silence this alarm for 5 min, press the Silence/Reset key.

• Sensor—Circuitry is provided to monitor the High Temperature
alarm sensor for shorts or open condition. A flashing sensor indicator
and an intermittent tone indicate a Sensor alarm. This alarm resets
itself.

• High Heater Temperature—The Heater Temperature indicator
flashes along with an intermittent alarm to indicate that the heater
temperature has exceeded 77°C (170.6°F). When this condition
occurs, the heater and heater indicators turn off. To silence this alarm
for
5 min, press the Silence/Reset key.

• Airflow—The Airflow indicator flashes along with an intermittent
alarm to indicate that the fan impeller has stopped rotating or is
missing. When this condition occurs, the heater and heater indicators
turn off. To silence this alarm for 5 min, press the Silence/Reset key.

• Low DC—The Low DC indicator flashes, and an intermittent alarm
sounds, to indicate that the incubator DC power source has fallen
below a predetermined value.

• Power failure—An internal battery that is separate from the battery
powers the Power Failure alarm circuit. The alarm lights and a
continuous tone sounds if AC power is lost and no external DC or
internal battery is present. To silence this alarm for 5 min, press the
Silence/Reset key. If the power source switches from AC to battery
or external DC to battery, the Power Failure alarm lights, and an
intermittent tone sounds. To reset the alarm, press the Silence/Reset
key.

SPECIFICATIONS

INTRODUCTION

FEATURES

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 3

Optional Equipment

Page 2 - 4 Transport Incubator (Model TI500) User Manual (67 990 70)

Optional equipment available for use with the transport incubator is
listed below. For part numbers for the accessories, refer to
“Replacement Parts” on page 6-13.

• IV pole

• Accessory shelf

• Pressure regulator and flow meter

• DC power cord adapter

• Adjustable stand

• Second battery option

The adjustable stands are designed to provide a convenient means of
moving the transport incubator. Each stand is adjustable to different
heights. They are designed to lock into the litter bar of an ambulance
with a fastener such as a FERNO®

1

Model 175 Series Cot Fastener

System.

NOTE:

The locking mechanisms vary with the ambulance or helicopter used.

SPECIFICATIONS

INTRODUCTION

FEATURES

1. Ferno® is a registered trademark of Ferno-Washington, Inc.

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 5

Specifications

Specifications for the transport incubator are provided below. The use of
infant seats, head hoods, or other accessories within the incubator can
alter the air flow pattern and affect the following:

• temperature uniformity

• temperature variability

• correlation of the incubator temperature reading to center mattress
temperature

• infant skin temperature

All specifications are subject to change without notice.

Physical Specifications

Feature Dimension

Transport incubator and
standard stand

(Ferno-Washington stand, model 147A)

Nominal length 102 cm (40")

Nominal width 56.5 cm (22.25")

Nominal height (low hood) 111.8 cm (44") maximum, 81.3 cm

(32") minimum

Nominal height (high hood) 116.2 cm (45.75") maximum, 85.7 cm

(33.75") minimum

Nominal weight (including
the incubator, adjustable
stand, and one battery)

Nominal weight (including
the incubator, adjustable
stand, and two batteries)

Transport incubator

Nominal length 95.9 cm (37.75")

Nominal width 52.7 cm (20.75")

Nominal height (low hood) 50.8 cm (20.00")

Nominal height (high hood) 55.2 cm (21.75")

Stands

Nominal length 102 cm (40.25")

72.1 kg (159 lb)

82.5 kg (181.9 lb)

Page 2 - 6 Transport Incubator (Model TI500) User Manual (67 990 70)

Feature Dimension

Nominal width 56.5 cm (22.25")

Nominal height 61.0 cm (24.00") - maximum, 30.5 cm

(12.00") - minimum

Environmental Specifications

Feature Dimension

Operating temperature range
(ambient)

10°C (50°F) to 30°C (86°F) (incubator
must be at least 3°C higher than the
ambient.)

Storage temperature -40°C (-40°F) to

+70°C (158°F) ambi-

ent

Relative Humidity Range 0% to 95% RH, non-condensing

Altitude Operating range:

sea level to 3 km
(10000 ft); non-pressurized ambient or
sea level to 12 km (40000 ft); pressur­ized ambient
Shipment range:

sea level to 12km

(40000 ft)

Performance Specifications

Feature Dimension

Mattress air velocity (aver­age air and oxygen-flow rate
circulated within the mattress
area defined by five points up
to a height of 4" above the
mattress)

Carbon dioxide (CO

) level

2

within the hood

Oxygen concentration Adjustable from a range of 21% to at

<20 cm/sec (39 ft/min)

Less than 0.5% when a 4% mixture of
CO

in the air is delivered at 750 ml

2

(25 oz) per min at a point 10 cm (4")
above the center of the mattress.

least 58% with oxygen flow rates

≥

6 LPM (1.6 gal/min).
(Concentrations are achieved in less
than 40 minutes at the corresponding
oxygen flow.)

SPECIFICATIONS

INTRODUCTION

FEATURES

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 7

Feature Dimension

Noise level within the hood Less than 60 dBa with ambient levels

to ≤ 50 dBa

Observation light 376.7 lx (35.0 fc) at 10 cm (4") above

the center of the mattress

Correlation of the displayed

≤ 1°C
incubator temperature to the
actual incubator temperature
at temperature equilibrium
(see “Technical Definitions”
on page 1-3).

Electrical Specifications

Feature Dimension

External power requirements 110V/120V AC, 50/60/400 Hz, 270W

maximum sine or square wave or

220V/240V AC, 50/60/400 Hz, 270W

maximum sine or square wave,

11V DC to 13V DC, 200W maximum,

26V DC to 30V DC, 200W maximum

Internal battery type Lead acid, vented, rechargeable

Internal battery voltage 12V DC nominal

Internal battery quantity 1 (2 optional)

Internal battery capacity 24 Amp hours per battery

Internal battery charge time
(from full discharge)

Internal battery life expect­ancy

Chassis leakage current 300µA or less (110V/120V AC units)

10 hours per battery

200 complete charge/discharge cycles

500µA or less (220V/240V AC units)

Page 2 - 8 Transport Incubator (Model TI500) User Manual (67 990 70)

Temperature Specifications

Feature Dimension

Operating temperature Maintains a differential of up to 25°C

(45°F) between the ambient
temperature and setpoint for 90 min
per battery. Example: With a setpoint
of 36°C (96.8°F) and ambient
temperature of 11°C (51.8°F), the
operating time (full heater, all heater
lights on) is 90 min for one battery, or
3 hours for two batteries.

Operating range (normal) 10°C (50°F) to 30°C (86°F)

The incubator setpoint must be at least

3.0°C (5.4°F) higher than the ambient
temperature.

Operating range (limited) 0°C (32°F) to 30°C (86°F)

At more extreme ambient
temperatures, the incubator
temperature may not be maintained
due to extreme ambient temperatures.

Relative humidity (RH)
operating range

Temperature setpoint range 21.5°C (70.7°F) ± 1.5°C to 38.0°C

Temperature rise time 30 min. (nominal)

Temperature variability 1.0°C (1.8°F)

Temperature overshoot 2.0°C (3.6°F)

Temperature uniformity 1.0°C (1.8°F)

0% to 95% RH non-condensing, IEC
class I equipment, internally-powered
equipment.

(100.4°F) in 0.1°C increments

SPECIFICATIONS

INTRODUCTION

FEATURES

Regulations, Standards, and Codes

The Transport Incubator, Model TI500 complies with the following
safety and performance standards:

• EN 60601-1—1990, Medical Electrical Equipment, Part 1: General
Requirements for Safety, including Amendments 1 and 2

• EN 60601-1-2—2002, Collateral Standard: Electromagnetic

Compatibility—Requirements and Tests

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 9

• EN 60601-2-20—1996, Particular Requirements for the Safety of
Transport Incubators, including Amendment 1

Guidance and Manufacturer’s Declaration— Emissions

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the unit
should ensure that the unit is used in such an environment.

Electromagnetic

Emissions Test Compliance

Environment—

Guidance

Radio frequency
(RF) emissions—
CISPR 11

Group 1 The TI500 Transport

Incubator uses RF
energy only for its
internal function.
Therefore, its RF
emissions are very
low and are not
likely to cause inter­ference with nearby
electronic equip­ment.

RF emissions
CISPR 11

Class B Although the TI500

Transport Incubator
is not intended for
operation from the
public low-voltage
power supply net­work, the product
does comply with the
more restrictive RF
Emission levels of
Class B.

Page 2 - 10 Transport Incubator (Model TI500) User Manual (67 990 70)

Guidance and Manufacturer’s Declaration— Emissions

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the unit
should ensure that the unit is used in such an environment.

Electromagnetic

Emissions Test Compliance

Environment—

Guidance

Harmonics
IEC 61000-3-2

Voltage fluctua­tions/flicker emis­sions
IEC 61000-3-3

Not Applicable The TI500 Transport

Incubator is suitable

Not Applicable

for use in all estab­lishments other than
domestic and those
directly connected to
the public low-volt­age power supply
network that supplies
buildings used for
domestic purposes.

SPECIFICATIONS

INTRODUCTION

FEATURES

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 11

Guidance and Manufacturer’s Declaration—Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Electromagnetic

Environment—

Guidance

The floors
should be
wood, con-

Immunity Test

Electrostatic
Discharge ESD
IEC 61000-4-2

IEC 60601 Test

Level

± 6 kV contact

± 8 kV air

Compliance

Level

± 6 kV contact

± 8 kV air

crete, or
ceramic tile. If
floors are cov­ered with syn­thetic, the
relative humid­ity should be at
least 30%.

Electrical fast
transient/burst
IEC 61000-4-4

± 2 kV for
power supply
lines

± 2 kV for
power supply
lines

Mains power
quality should
be that of a typ­ical commer­cial or hospital
environment.

There are no
I/O cables for
this product.

Mains power
quality should

Surge
IEC 61000-4-5

± 1 kV for
input/output
lines

± 1 kV Differ­ential

N/A for
input/output
lines

± 1 kV Differ­ential

be that of a typ­± 2 kV Com­mon

± 2 kV Com­mon

ical commer-

cial or hospital

environment.

Page 2 - 12 Transport Incubator (Model TI500) User Manual (67 990 70)

Guidance and Manufacturer’s Declaration—Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Electromagnetic

Environment—

Guidance

Mains power
quality should
be that of a typi­cal commercial
or hospital
environment. If
the user of the
TI500 Transport
Incubator
requires contin-

Immunity Test

Voltage dips,
short interrup­tions and volt­age variations
on power sup­ply input lines
IEC 61000-4­11

IEC 60601 Test

Level

<5% U

T

(> 95% dip in

U

) for 0.5

T

cycles

40% U

T

(60% dip in

U

) for 5

T

cycles

Compliance

Level

<5% U

T

(> 95% dip in

U

) for 0.5

T

cycles

40% U

T

(60% dip in

U

) for 5

T

cycles

ued operation

70% U

T

(30% dip in

U

) for 25

T

cycles

<5% U

T

(> 95% dip in

U

) for 5 s

T

70% U

T

(30% dip in

U

) for 25

T

cycles

<5% U

T

(> 95% dip in

U

) for 5 s

T

during power
mains interrup­tions, it is rec­ommended that
the TI500 Trans­port Incubator
be powered from
an
uninterruptible
power supply or
a battery.

SPECIFICATIONS

INTRODUCTION

FEATURES

Note: The TI500
Transport Incu­bator, with its
internal bat­tery(s), provides
continued opera­tion during
power mains
interruptions.

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 13

Guidance and Manufacturer’s Declaration—Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Electromagnetic

Environment—

Guidance

quency mag-

netic fields

should be at

levels charac-

Immunity Test

Power fre­quency
(50/60 Hz)
magnetic field
IEC 61000-4-8

IEC 60601 Test

Level

Compliance

Level

3 A/m 3 A/m Power fre-

teristic of a typ-

ical location in

a typical com-

mercial or hos-

pital

environment.

Note U

is the a.c. mains voltage prior to application of the test level.

T

Page 2 - 14 Transport Incubator (Model TI500) User Manual (67 990 70)

Guidance and Manufacturer’s Declaration— Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Immunity Test IEC 60601 Test

Level

Conducted RF
IEC 61000-4-6

3 Vrms

150 kHz to 80
MHz outside

ISM bands

a

Compliance
Level

3 Vrms

Electromagnetic
Environment—
Guidance
Recommended
Separation
Distance

Portable and
mobile RF
communica­tions equip­ment should be
used no closer
to any part of
the TI500
Transport Incu­bator, includ­ing cables, than
the recom­mended separa­tion distance
calculated from
the equation
applicable to
the frequency
of the transmit­ter.

Recommended

separation

distance

d 1.2 P=

INTRODUCTION

FEATURES

SPECIFICATIONS

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 15

Guidance and Manufacturer’s Declaration— Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Immunity Test IEC 60601 Test

Level

10 Vrms

150 KHz to 80

a

MHz

Radiated RF

10 V/m 10 V/m

IEC 61000-4-3

Compliance
Level

10 Vrms

Electromagnetic
Environment—
Guidance
Recommended
Separation
Distance

d 1.2 P=

d 1.2 P=

MHz to 800

MHz

80

80 MHz to 2.5
GHz

d 2.3 P=

800 MHz to 2.5

GHz

Page 2 - 16 Transport Incubator (Model TI500) User Manual (67 990 70)

Guidance and Manufacturer’s Declaration— Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Immunity Test IEC 60601 Test

Level

Compliance
Level

Electromagnetic
Environment—
Guidance
Recommended
Separation
Distance

where P is the
maximum out­put power rat­ing of the
transmitter in
watts (W)
according to the
transmitter
manufacturer
and d is the rec­ommended sep­aration distance

in meters (m).
in watts and D
is the recom­mended
separation dis­tance in meters.

INTRODUCTION

FEATURES

SPECIFICATIONS

b

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 17

Guidance and Manufacturer’s Declaration— Immunity

The TI500 Transport Incubator is intended for use in the electromag­netic environment specified below. The customer or user of the TI500
Transport Incubator should assure that the unit is used in such an envi­ronment.

Immunity Test IEC 60601 Test

Level

Compliance
Level

Electromagnetic
Environment—
Guidance
Recommended
Separation
Distance

Fields strengths

from fixed RF

transmitters, as

determined by

an electromag-

netic site sur-

c

vey

, should be
less than the
compliance
level in each
frequency

d

range.

Interference
may occur in
the vicinity of
equipment
marked with
the following
symbol:

a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80

MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957
MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

Page 2 - 18 Transport Incubator (Model TI500) User Manual (67 990 70)

b. The compliance levels in the ISM frequency bands between 150 kHz and 80

MHz and in the frequency range 80 MHz to 2.5 GHz are intended to
decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For
this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency
ranges.

c. Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To access the electromagnetic environment due to fixed RF
transmitters, an electromagnetic sit survey should be considered. If the
measured field strength in the location in which the TI500 Transport
Incubator is used exceeds the applicable RF compliance level above, the
TI500 Transport Incubator should be observed to verify normal operation.
IF abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the TI500 Transport Incubator.

d. Over the Frequency range 150 kHz to 80 MHz, field strengths should be less

than 3 V/m.

NOTE:

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE:

These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people

SPECIFICATIONS

INTRODUCTION

FEATURES

Transport Incubator (Model TI500) User Manual (67 990 70) Page 2 - 19