Dräger Globe-Trotter GT5400 User manual

Operator’s Manual
Portable Bedside Capnograph
PN: 010678-A

Notice: Purchase of this instrument confers no express or implied
license under any Oridion Medical patent to use the instrument with
any accessory that is not manufactured or licensed by Oridion Medical
1987 Ltd.
Capnography is covered by one or more of the following United
States patents: 6,437,316; 5,300,859; 6,428,483; 6,997,880 and their
foreign equivalents. Additional patent applications pending.
Oridion®, Microstream®, FilterLine®, Smart CapnoLine®,
CapnoLine®, Smart BiteBloc™, NIV Line™, Capnostream™,
Microcap®, Microcap®Plus, and VitalCap®are trademarks or
registered trademarks of Oridion Medical 1987 Ltd.
Exemptions
Oridion's liability under this warranty does not include any
transportation damage or other charges or liability for direct, indirect
or consequential damages or delay resulting from improper use or
application of the product or the substitution upon it of parts or
accessories not approved by Oridion.
All information in this manual is believed to be correct. Oridion shall
not be liable for errors contained herein with the performance or use
of this manual.
Copyright © 2006 Oridion Medical 1987 Ltd., All rights reserved.

Portable Bedside Capnograph 3
Table of Contents
CHAPTER 1 SAFETY INFORMATION....................... 7
Warnings ............................................................ 7
Symbols ........................................................... 10
CHAPTER 2 INTRODUCTION.................................. 11
Monitor Features .............................................. 11
CHAPTER 3 OVERVIEW .......................................... 13
Principles of Operation..................................... 13
CHAPTER 4 INITIAL SETUP.................................... 19
Power Requirements ....................................... 19
Unpacking and Inspection................................ 22
Start-up and Self test....................................... 23
Measuring Mode .............................................. 25
Quick Guide ..................................................... 26
CHAPTER 5 CONSUMABLES ................................. 27
MICROSTREAM EtCO2 Consumables ........... 27
CHAPTER 6 BASIC OPERATION............................ 29
Data Display Screens ...................................... 29
Displayed Data Options ................................... 32
Alarm Functions ............................................... 33
Alarm Limits Menu ........................................... 35
Alarm Silence/Standby Menu........................... 37
Instrument Settings Menus .............................. 38
CHAPTER 7 COMMUNICATION INTERFACE ........ 47
Communication Interface ................................. 47
CHAPTER 8 TROUBLESHOOTING......................... 49
Alarms and Messages ..................................... 49
Troubleshooting Guide..................................... 54
CHAPTER 9 MAINTENANCE................................... 57
Periodic Maintenance ...................................... 57
Service ............................................................. 58

4 Portable Bedside Capnograph
Cleaning ........................................................... 58
Calibration ........................................................ 59
CO2 Calibration Check..................................... 59
Returning the Monitor....................................... 61
Technical assistance ........................................ 62
CHAPTER 10 SPECIFICATIONS..............................63
Physical ............................................................ 63
Environmental .................................................. 63
Safety Standards.............................................. 64
Compliance ...................................................... 64
Manufacturer’s Declaration .............................. 67
Performance..................................................... 67
Power Specifications ........................................ 68
Electrical........................................................... 69
Components and User Interface ...................... 75

Portable Bedside Capnograph 5
List of Figures
Figure 1: Monitor Front and Side View............................. 17
Figure 2: Monitor Rear View ............................................18
Figure 3: Initialization Screen...........................................24
Figure 4: Quick Guide ...................................................... 26
Figure 5: Monitor Display Screen and LEDs .................... 30
Figure 6: Pump Off...........................................................45
Figure 7: Pump Off Additional Time .................................46
Figure 8: Pump Off/On Label ...........................................46

6 Portable Bedside Capnograph
List of Tables
Table 1: Symbols on the Device ...................................... 10
Table 2: Display Screens................................................. 32
Table 3: Factory Default Alarm Range Values................. 35
Table 4: Alarm Limits....................................................... 35
Table 5: Alarm Silence/Standby ...................................... 37
Table 6: Instrument Settings Parameters (Menu 1) ......... 38
Table 7: Instrument Settings Parameters (Menu 2) ......... 40
Table 8: Changing Instrument Settings (Menu 1) ............ 41
Table 9: Changing Instrument Settings (Menu 2) ............ 42
Table 10: Institutional Settings......................................... 43
Table 11: Warning Messages .......................................... 50
Table 12: Caution Messages ........................................... 51
Table 13: Advisory Messages.......................................... 52
Table 14: Silent Advisory Messages................................ 53
Table 15: Troubleshooting Guide .................................... 55
Table 16: Accessing the Service Mode............................ 58
Table 17: CO2 Calibration Check .................................... 60

Portable Bedside Capnograph 7
Do not touch this field - it is
invisible and does not appear in the
final document
Chapter 1
Safety Information
Warnings
Symbols
To use the portable capnograph correctly and safely, carefully read
this operator’s manual and the Directions for Use for the Microstream
EtCO2consumables. Use of the monitor requires full understanding
and strict observance of these instructions, the precautionary
information in boldface type, and the specifications.
Warnings
General
WARNING: If uncertain about the accuracy of any measurement,
check the patient’s vital signs by alternate means, and
then make sure the monitor is functioning correctly.
WARNING: To ensure patient safety, do not place the monitor in any
position that might cause it to fall on the patient.
WARNING: Carefully route patient cabling (FilterLine) to reduce the
possibility of patient entanglement or strangulation.
WARNING: Do not lift the monitor by the FilterLine, as it could
disconnect from the monitor, causing the monitor to fall
on the patient.
WARNING: To ensure accurate performance and prevent device
failure, do not expose the monitor to extreme moisture,
such as rain.
WARNING: CO2readings and respiratory rate readings can be
affected by certain ambient environmental conditions
and certain patient conditions.

Safety Information
8 Portable Bedside Capnograph
WARNING: The monitor is a prescription device and is to be
operated by qualified healthcare personnel only.
MRI Scanning
WARNING: During MRI scanning, the monitor must be placed
outside the MRI suite. When the monitor is used outside
the MRI suite, EtCO2monitoring can be implemented
using the FilterLine XL. (Refer to MRI Scanning on
page 44.)
Alarms
WARNING: Do not silence the audible alarm if patient safety may be
compromised.
WARNING: Always respond immediately to a system alarm since the
patient may not be monitored during certain alarm
conditions.
WARNING: Before each use, verify that the alarm limits are
appropriate for the patient being monitored.
WARNING: Check the audible alarm silence duration before
temporarily silencing the audible alarms.
Fire Hazard
WARNING: When using the monitor with anesthetics, nitrous oxide,
or high concentrations of oxygen, connect the gas outlets
to a scavenger system.
WARNING: The monitor is not suitable for use in the presence of
flammable anesthetic mixture with air, oxygen, or
nitrous oxide.
WARNING: The FilterLine may ignite in the presence of O2when
directly exposed to laser, ESU devices, or high heat.
When performing head and neck procedures involving
laser, electrosurgical devices, or high heat, use with
caution to prevent flammability of the FilterLine or
surrounding surgical drapes.

Warnings
Portable Bedside Capnograph 9
Electrical
WARNING: To protect against electric shock hazard, the monitor’s
cover is to be removed only by qualified service
personnel. There are no user-serviceable parts inside.
WARNING: To ensure patient electrical isolation, connect only to
other equipment with circuits that are electrically
isolated.
WARNING: Use only the medical grade AC adapter provided by the
manufacturer. If in doubt about the integrity of the mains
supply connection, operate the monitor from its internal
battery pack.
WARNING: Do not connect to a printer or to a PC unless using the
Communication Adapter provided by the manufacturer
as an optional accessory. The printer and PC (when
connected to the patient through the Communication
Adapter) must be distanced from the patient
environment by at least 1.5 m.
Electro-magnetic Interference
This device has been tested and found to comply with the
requirements for medical devices according to the standard EN60601-
1-2/2001. These standards are designed to provide reasonable
protection against harmful interference in a typical medical
installation.
However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise in the healthcare
environments (for example, cellular phones, mobile two-way radios,
or electrical appliances), it is possible that high levels of such
interference, due to close proximity or strength of a source, may result
in disruption of performance of this device.
WARNING: Operating high frequency electrosurgical equipment in
the vicinity of the monitor can produce interference in
the monitor and give incorrect measurements.
WARNING: Do not use the monitor with nuclear spin tomography
(MRT, NMR, NMT) as the function of the machine may
be disturbed.

Safety Information
10 Portable Bedside Capnograph
Symbols
The following symbols appear on the monitor and monitor LCD
(liquid crystal display):
Table 1: Symbols on the Device
Symbol Description
See Directions for Use
Gas Outlet
Defibrillator-proof Type BF
equipment
(patient electrically isolated)
Audio Alarms Off
Plug Icon
Battery Icon
Respiratory Rate (breaths per
minute)
EtCO2End tidal carbon dioxide value
DC Input
Refer to manual for connector
interface and other information
Pump Off/On Pump Off

Portable Bedside Capnograph 11
Do not touch this field - it is
invisible and does not appear in the
final document
Chapter 2
Introduction
Monitor Features
This manual provides directions for setup and operation of the
portable capnograph monitor.
The device is a portable capnograph that continuously monitors end
tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide
(FiCO2) and respiratory rate (RR). The monitor is for monitoring only
and must be used in the continuous presence of a qualified healthcare
provider. It is intended for use in any environment where continuous,
noninvasive monitoring of these parameters is desired, including
hospital and hospital type facilities. The monitor is intended for use on
adult, pediatric, and infant/neonatal patients.
Monitor Features
•Capnograph in a small, portable, lightweight monitor
•Measures and displays EtCO2, FiCO2, and respiration rate,
in one graphic and two digital displays
•Displays CO2waveforms and trends
•Utilizes a wide range of Microstream EtCO2consumables
for all applications
•Operates on mains line power or a rechargeable Nickel
Metal Hydride battery pack
•Employs audible and visual alarm warnings for monitored
parameters and instrument malfunctions
•Provides user selectable language options: English,
French, German, Spanish, Italian, Dutch, Swedish,
Norwegian, and Portuguese

Introduction
12 Portable Bedside Capnograph
•Displays EtCO2and FiCO2values in mmHg, kPa or
Vol%.
•Provides output for printer, PC, and Digital to Analog
Converter
•Provides interface to hospital nurse call systems.

Portable Bedside Capnograph 13
Do not touch this field - it is
invisible and does not appear in the
final document
Chapter 3
Overview
Principles of Operation
FilterLine
Displays, Controls, and Connectors
The monitor incorporates Oridion’s Microstream capnography
technology.
Principles of Operation
The monitor uses Microstream non-dispersive infrared (NDIR)
spectroscopy to continuously measure the amount of CO2during
every breath, the amount of CO2present at the end of exhalation
(EtCO2) and during inhalation (FiCO2), and the Respiratory Rate.
Infrared spectroscopy is used to measure the concentration of
molecules that absorb infrared light. Because the absorption is
proportional to the concentration of the absorbing molecule, the
concentration can be determined by comparing its absorption to that
of a known standard.
The Microstream EtCO2consumables deliver a sample of the inhaled
and exhaled gases from the ventilator circuit or directly from the
patient (via an oral/nasal cannula) into the monitor for CO2
measurement. Moisture and patient secretions are extracted from the
sample while maintaining the shape of the CO2waveform.
The 50 ml/min. sampling flow rate reduces liquid and secretion
accumulation, decreasing the risk of obstruction in the sample
pathway in humid ICU environments.
Once inside the Microstream CO2sensor, the gas sample goes through
a microsample cell (15 microliters). This extremely small volume is

Overview
14 Portable Bedside Capnograph
quickly flushed, allowing for fast rise time and accurate CO2readings,
even at high respiration rates.
The Microbeam IR source illuminates the microsample cell and the
reference channel. This proprietary IR light source generates only the
specific wavelengths characteristic of the CO2absorption spectrum.
Therefore, no compensations are required when different
concentrations of N2O, O2, anesthetic agents, and water vapor are
present in the inhaled and exhaled breath. The IR that passes through
the microsample cell and the IR that passes through the reference
channel are measured by the IR detectors.
The microcomputer in the monitor calculates the CO2concentration
by comparing the signals from both channels.
Microstream EtCO2Consumables
The following products comprise the Microstream EtCO2
consumables:
Sample Lines and Airway Adapter Sets for Intubated Patients:
•FilterLine Set (for non–humid environments).
•FilterLine H Set (for humid environments).
Nasal and Oral/Nasal Cannulas for Non-intubated patients:
•Smart CapnoLine Plus – for use in procedural sedation.
Also available with O2delivery.
•CapnoLine H – for patients receiving hi–flow oxygen by
mask, on long term CPAP or Bi-PAP, or post-op pain
management. Also available with O2delivery.
•NIV Line – for use under oxygen, CPAP, Bi–PAP or NPPV
mask.
*Smart products provide oral and nasal sampling.
H products are for long term use.

FilterLine
Portable Bedside Capnograph 15
Special Procedure FilterLines
•FilterLine XL – Provides extended length so that the
monitor can be used safely during MRI (see MRI Scanning
on page 44).
Note: The generic term FilterLine, used in this manual, is
interchangeable with any of the Microstream EtCO2
consumables.
FilterLine
The FilterLine has five active elements that work together to offer a
solution to the problems that have previously posed challenges to
capnography in ICU, emergency, and intra-transport applications.
These elements are described below.
*Hydrophobic filter
The hydrophobic filter is located at the end of the sample line that is
closest to the capnograph. This filter strips the remaining water vapor
from the gas sample while keeping a laminar flow of the gas. This
laminar flow minimizes distortion of the CO2waveform.
This filter is made of a 0.2 μhydrophobic porous medium.
*Drying element
The drying element is a tube made of a synthetic material that is
chemically stable and has high water absorption. This material allows
the water vapor to pass outside the tube, thereby adjusting the
humidity inside the FilterLine close to the level of humidity in the
ambient air.
*Sample line
The sample line has low dead space due to its small internal diameter.
This provides a sharp waveform and an accurate CO2reading at a high
breath rate per minute. The sample line is not affected by gases and
anesthetic agents in the operating room environment.

Overview
16 Portable Bedside Capnograph
*FilterLine Recognition Safeguard
When the FilterLine is attached to the monitor, the FilterLine
Recognition Safeguard (FRS) identifies the FilterLine and activates
the monitor, thus enabling measuring.
*Airway Adapter
The airway adapter design provides multiple channels for the sampled
air from the airway, minimizing the possibility of water infiltration or
line blockage. These multiple channels allow uninterrupted
monitoring for all adapter orientations and in all applications. The
airway adapter provides optimal performance in all directions and is
seldom disabled by secretions or liquids.

Displays, Controls, and Connectors
Portable Bedside Capnograph 17
Displays, Controls, and Connectors
Figure 1: Monitor Front and Side View
The numbered labels in Figure 1: Monitor Front and Side View are
described below.
1. On/Off Switch
2. Alarm Bar
3. Digital Display of EtCO2
and Respiration Rate
4. Graphic Display
5. Contrast/Value Change
Button
6. Next/Menu Button
7. Battery Pack
8. Event/Home Button
9. Port for AC Adapter or
communication adapters
10. Alarm Silence/Alarm
Silence Menu Button
11. Alarm Silence Indicator
12. Gas Outlet
13. Photo Resistor
14. FilterLine Input Connector
15. Pump Off/On Adhesive
Label
15

Overview
18 Portable Bedside Capnograph
5
3
2
1
4
Figure 2: Monitor Rear View
The numbered labels in Figure 2: Monitor Rear View are described
below.
1. Clamp Connector 3. Serial Number Label
2. Space for Quick Guide
Adhesive Label
4. Battery Pack Release
Button
5. Battery Pack

Portable Bedside Capnograph 19
Do not touch this field - it is
invisible and does not appear in the
final document
Chapter 4
Initial Setup
Power Requirements
Unpacking and Inspection
Start-up and Self test
Measuring Mode
Quick Guide
Power Requirements
The monitor operates on batteries or on AC power. It is equipped with
a rechargeable Nickel Metal Hydride battery pack. When a power
outlet is available, use the medical grade AC adapter provided with
the monitor.
Before using the monitor in the field, ensure that the battery pack is
fully charged. At the Measuring mode, check that the battery icon at
the right side of the graphic display is full.
Note: If the battery is not fully charged, the icon may first
show as full and after a short period of time will drop
to indicate the real charge level.
A fully charged battery pack provides between four and seven
operating hours, depending on power management (refer to Table 6:
Instrument Settings Parameters (Menu 1) on page 38 for a description
of the power management options).
WARNING: Use only the medical grade AC adapter provided by the
manufacturer. If unsure about the integrity of the line
connection, operate the monitor from its internal battery
pack.
WARNING: To ensure patient electrical isolation, connect only to
other equipment with circuits that are electrically
isolated.

Initial Setup
20 Portable Bedside Capnograph
Battery and Power Usage
If power is lost when the monitor is operating from AC power, it
automatically switches to its internal battery pack for power.
A plug-shaped icon at the bottom right side of the graphic display
is displayed when the monitor operates from an external power source
and the battery pack is fully charged. A battery-shaped icon is
displayed when the monitor operates from the battery pack. The
battery icon will show the battery pack’s approximate charge level.
An advisory message, Battery !, appears when approximately 40
minutes of battery charge remains. A caution message, Battery !!,
appears when approximately 15 minutes of charge time remains.
While the monitor is connected to AC power, the battery pack can be
replaced without interrupting monitoring.
Battery Pack
Before using a new battery pack for the first time, charge and
discharge the battery three times to ensure full battery capacity. For
charging and discharging, the Microstream Capnograph Battery
Charger is recommended (refer to the Microstream Capnograph
Battery Charger Directions for Use).
Internal Recharge Function
CAUTION: Do not attempt to disassemble the battery pack. It is a
sealed unit and has no serviceable parts inside.
When the monitor is connected to an external power source (even if
the monitor is turned off), the battery pack charges automatically. If
the instrument is on during charging, the battery-shaped icon displays
a filling pattern. It takes approximately 4.5 hours to fully charge an
empty battery pack. Additional battery packs can be purchased from
your local representative.
The recommended temperature for battery charging is between 5ºC
and 45ºC.