Draeger Medical Systems, Inc.
16 Electronics Avenue
Danvers, MA 01923
USA
Authorized EC representative:
Dräger Medical AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck
Germany
Infinity Gamma Series User’s Guide
Software Version VF4
This product is covered by one or more of the following patents: 5,224,484;
5,224,740; 5,240,008; 5,285,791; 5,355,890; 5,337,751; 5,375,604.
This device bears the ! label in accordance with the provisions of the Directive 93/42/EEC of June 14, 1993 concerning medical devices.
0123
!"
Dräger Medical AG & Co. KGaA, 2003. All rights reserved.
Printed in the United States of America.
Dräger reserves the right to modify the design and specifications contained
herein without prior notice. Please contact your local Dräger Sales Representative for the most current information.
Reproduction in any manner, in whole or in part, in English or in any other
languages, except for brief excerpts in reviews and scientific papers, is prohibited without prior written permission of Dräger Medical AG & Co. KGaA.
All Dräger devices are intended for use by qualified medical personnel only.
CAUTION: Federal Law in the United States restricts these devices to
sale by, or on order of a physician.
Before using all Dräger devices, read all the manuals that are provided with
your device carefully. Patient monitoring equipment, however sophisticated,
should never be used as a substitute for the human care, attention, and critical
judgment that only trained health care professionals can provide.
What’s New
The functionality of the Infinity Gamma Series patient monitor
has been improved and expanded to include the following new
features in software version VF4:
!Support of gas monitoring functions in anesthesia and operat-
ing room environments. The Gamma XL can now display
concentrations of CO
halothane, isoflurane, enflurane, sevoflurane, and desflurane.
The Gamma XL receives these gas values from a Dräger Scio
multigas module. Note: This functionality is only available
for the Gamma XL (and not the Gamma). For information
about multigas monitoring, see Chapter 14, Multigas.
!Support of network laser printers. Recording requests can be
sent from the Infinity Gamma Series monitor via the Infinity
network to a network laser printer. For information about
recording functions, see Chapter 7, Recordings.
, N2O, O2 and of the anesthetic agents
2
!Improved SpO
performance during motion artifact. For
2
information about pulse oximetry, see Chapter 12, Pulse Oximetry.
NOTES:
The Gamma XL monitor with Anesthetic Gas Monitoring
!
requires FDA 510(k) review.
!The Gamma XL monitor with Anesthetic Gas Monitoring is not
yet licensed in accordance with the Canadian Medical Devices
Regulations.
VF4Infinity Gamma SeriesPage iii
Infinity Gamma Series Software Release Notes
Software Version VF4
!Wireless network operation requires special configurations of the monitor-
ing network and the MULTIVIEW WORKSTATION (a service function). If
you experience problems with wireless network operations, contact your
Service personnel.
!When moving and assigning a wireless monitor to a different central sta-
tion, the original central station may emit a brief network error tone and
display an Offline message instead of the message Bed Disconnected.
However, there is no disruption of network monitoring and the Offline
message clears as soon as you assign a new bed to the central viewport.
!When you change the units of measure at the bedside and the central sta-
tion is showing the monitor’s bed view, you must first exit the central bed
view, before the change of units appears at the central station.
!For network and card data transfer:
— Occasionally, after a data transfer from an Infinity Delta Series monitor,
you may see three or four ST trends instead of the two ST leads monitored
by the Infinity Gamma Series monitor.
!For network data transfer only:
— If ST is enabled, the ST data transferred from an Infinity Delta Series
monitor (VE0) or from a M
I and II, regardless of the ST leads selected on the Infinity Gamma Series
monitor. Note: Other ST data will be permanently lost.
— After a network transfer of telemetry data to an Infinity Gamma Series
monitor, ST trend points may appear two minutes apart.
— The IBP data transferred from an Infinity Delta Series monitor (VE0) to
an Infinity Gamma Series monitor is labelled GP1 and GP2.
!NBP parameter values transferred from an Infinity Gamma Series monitor
to an Infinity Delta Series monitor will be displayed in the trend graphs
rather than in the trend tables of the destination monitor.
!On rare occasions, a docked monitor may reset when entering the
Transfer Menu under certain network conditions. The monitor returns
to the state prior to the reset within 30 seconds.
ULTIVIEW Telemetry System (VE0) is ST lead
!When power-cycling the monitor or admitting a new patient, saved moni-
toring settings may occasionally return to default settings. Check monitoring settings after these events.
!If the Scio module is unable to measure the concentration of N
itor may enter the error code *A* (artifact) instead of *F* (failure) into the
O, the mon-
2
trend storage.
Page ivInfinity Gamma SeriesVF4
!
Occasionally, the ECG waveform is not displayed in the second waveform
channel, when you assign SpO2 to the first waveform channel. In this case,
click on the second waveform channel and select the desired ECG lead
again.
!When admitting a patient at the MULTIVIEW WORKSTATION, the monitor
does not store the admit date, if it is the current date. In this case, you must
enter the admit date via the monitor’s Patient Admit menu.
!When the values of an anesthetic agent exceed the measuring range, the
monitor displays +++ in the agent parameter box and cycles two out-ofrange error messages, one correctly identifying the agent with out-ofrange values, the other showing a previously monitored agent.
VF4Infinity Gamma SeriesPage v
Documentation Features
Notes, Cautions, Warnings
NOTE: A note presents information that helps you operate the
equipment or connected devices.
CAUTION: A caution provides information or instructions that
must be followed to ensure proper operation and performance of
the equipment
WA RN I NG : A warning contains important information
regarding possible danger to you or the patient that is
present during normal operation of the equipment.
CAUTION: Read all operating instructions carefully before using
the monitor. Specific warnings and cautions are found throughout
the User’s Manual where they apply.
CAUTION: These devices are not intended for use in the same
room as magnetic resonance equipment.
WA RN I NG : Monitor operation is currently not supported in the following environments: magnetic resonance imaging (MRI), aircraft, ambulance, home or
hyperbaric chamber environments.
CAUTION: Use only batteries that are approved by Dräger (contact your local representative). The use of non-approved batteries
may damage the device.
NOTE: Dräger recommends replacing any lead-acid battery after
12 months of continued use. For safe disposal of lead-acid and lithium ion batteries, follow your local regulations. To prevent risk of
fire or explosion, never dispose of the battery in fire.
Dräger is liable for the safety, reliability and performance of its
equipment only if (a) maintenance, repairs, and modifications are
carried out by authorized personnel, (b) if components are
replaced with Dräger approved spare parts and (c) if the devices
are used in accordance with Dräger Operating Instructions.
A full technical description is available upon request from your
local Dräger representative.
Electromagnetic Compatibility
The monitor has been designed and tested for compliance with
current regulatory standards as to its capacity to limit electromagnetic emissions (EMI), and also as to its ability to block the
effects of EMI from external sources.
The monitor complies with the following standards pertaining to
EMI emissions and susceptibility: EN55011 and EN60601-1-2.
Page 1-2Infinity Gamma SeriesVF4
Reducing EMI
To reduce possible problems caused by electromagnetic interference, we recommend the following:
!Use only Dräger-approved accessories.
!Ensure that other products used in areas where patient moni-
toring and/or life-support is used comply to accepted emissions standards (EN55011).
!Try to maximize the distance between electromedical
devices.
!Strictly limit exposure and access to portable radio-frequency
sources (e.g., cellular phones and radio transmitters). Be
aware that portable phones may periodically transmit even
when in standby mode.
!Maintain good cable management. Do not route cables over
electrical equipment. Do not intertwine cables.
!Ensure all electrical maintenance is performed by qualified
personnel.
Overview
Site of Operation
CAUTION: The site of operation for the monitor must meet temperature, humidity, and air pressure requirements. For details, see
the product description in Appendix A.
WA RN I NG : Do not operate the monitor in presence of
flammable anesthetic mixtures with air, oxygen, or
nitrous oxide. Do not use the monitor near devices with
microwave or other high frequency emissions that may
interfere with the monitor’s operation.
WA RN I NG : If fluids are accidentally spilled on the monitor, it should be removed from service immediately and
thoroughly inspected by your Biomed to ensure that
there is no compromise in electrical safety.
CAUTION: Place the monitor on a flat and stable surface to prevent it from falling. Do not place the monitor into a cabinet, wall
recess or similar enclosure during operation. These units are convection cooled (no fan) and need adequate airflow to dissipate heat.
VF4Infinity Gamma SeriesPage 1-3
Electrical Safety
CAUTION: Operate the monitor and any connected devices only
in a clinical environment where the electrical installation is in
accordance with local electric codes. The universal AC adapter,
CPS, or IDS should be connected to a fully tested, hospital-grade
outlet with proper grounding.
WA RN I NG : Dräger devices are not intended for use in
areas where there is a danger of explosion. If the devices
are used where flammable anesthetic substances are
used, the possibility of an explosion cannot be excluded.
If the AC adapter, CPS, or IDS is disconnected, the monitor “Battery charger” light turns off and the unit switches immediately to
battery power.
Connections to Peripheral Devices
All peripheral devices and connections to the monitor (except the
Infinity network) must comply with IEC 60601-1 requirements.
CAUTION: In the interest of patient safety and equipment performance, Dräger does not authorize the connection of other manufacturers’ equipment not approved by Dräger. It is the user's
responsibility to contact Dräger to determine compatibility and
warranty status if connections to other manufacturers' equipment
are desired.
CAUTION: When connecting peripheral devices to the monitor,
make sure that the entire system complies with the following
requirement: IEC 60601-1-1: Safety requirements for medical electrical systems.
Page 1-4Infinity Gamma SeriesVF4
Safety, Inspection, and Maintenance
WA RN I NG : Because of the danger of electric shock,
never remove the cover of any device while in operation
or connected to a power outlet via the AC adapter.
In the interest of safety, regular equipment inspection and maintenance is required. Once a year, check all cables, devices, and accessories for damage, ground resistance, chassis and patient leakage
currents, and all alarm functions. Also, ensure that all safety labels
are legible. Maintain a record of these safety checks. For additional
information, refer to the Service manual.
Leakage current will increase when connecting multiple medical
devices to a patient. Ensure the electrical shock classification for
each device is suitable for the intended application.
Dräger recommends that safety and functional checks be performed on the monitor at least once each year. The temperature
and non-invasive blood pressure circuits of the monitor should be
calibrated at least every two years. These checks should be performed by authorized personnel, as described in the appropriate
Service manual.
Overview
When main or battery power is not available, the monitor stores
patient data and settings in an internal battery backed-up SRAM.
This internal battery will last approximately 10 years if the monitor is operated from main power or from the lead acid or lithium
ion battery.
CAUTION: To preserve the life of the internal battery, always
leave the monitor connected to main power (using the AC adapter)
when not in use. If the monitor is stored unconnected
lead acid/lithium ion battery power, the capacity of the internal battery will be drained in approximately three years.
VF4Infinity Gamma SeriesPage 1-5
from line or
Electrosurgery and Defibrillation Safety
The monitor is protected against high-frequency interference
from electrosurgery units and discharges from defibrillators, as
well as against 50- and 60-Hertz power line interference.
WA RN I NG : The monitor is not protected against highfrequency interference from diathermy equipment.
CAUTION: During Electrosurgery, observe the following guidelines to minimize ESU interference and provide maximum user and
patient safety:
!Use the ESU block to connect ECG cables.
!Keep all transducers and intermediate cables off of earth
ground and away from the ESU knife and return wires.
!Use the SpO
heart rate.
!Use rectal temperature probe sheaths to cover any internally
placed temperature sensors.
!Always use the accessories designed for ESU environments.
!If pacer detection is on, the ESU interference may be detected
as pacer spikes displayed on the ECG.
pulse rate instead of the ECG to determine the
2
Pacemaker Safety
WA RN I NG : Rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter
alarms. Keep pacemaker patients under close surveillance.
WA RN I NG : Make sure that pacer detection is turned off
for patients without pacemakers, and turned on for
patients with pacemakers.
Page 1-6Infinity Gamma SeriesVF4
Device Markings
Overview
#
$
%
&
'
~
(
0123
)
IPX1
Power On/Off, Power standby.
Battery operated equipment.
Attention, consult the accompanying documents.
Type CF, defibrillator-proof equipment.
Direct current.
Alternating current.
Danger: Risk of explosion if used in presence of flammable anesthetics.
This device bears the ) label in accordance with the
provisions of the Directive 93/42/EEC of 14June 1993
concerning medical devices.
Protected against harmful effects of dripping water.
NBP
IBP
VF4Infinity Gamma SeriesPage 1-7
Non-Invasive Blood Pressure.
Invasive Blood Pressure.
General Description
The Gamma Series monitor is a durable, lightweight, and portable patient monitor that can operate as a stand-alone device or as
part of the Dräger Infinity network. The Dräger P
concept allows the monitor’s quick and easy disconnection from
the network, and the monitor can travel with the patient from one
clinical station to another — i.e. from the bedside to the OR to a
step-down unit and back.
The monitor provides high-quality patient care for adult, pediatric, and neonatal patients in clinical environments.The monitor
provides high-quality patient care for adult, pediatric, and neonatal patients in clinical environments and offers the following
monitoring functions:
!ECG and Heart Rate Monitoring (3-, 5-, and 6-lead).
!Arrhythmia Detection (Basic and Full).
!2-lead ST Segment Analysis (adult and pediatric mode only).
!Respiration Monitoring (impedance pneumography).
!Pulse Oximetry.
!End-tidal CO2 Monitoring.
ICKAND GO™
!Anesthetic Gas Monitoring (Gamma XL only).
!Temperature Monitoring.
!OxyCardiorespirogram (neonatal mode only).
!Non-Invasive Blood Pressure Monitoring.
!Invasive Blood Pressure Monitoring.
!Trend Storage.
!Event Storage.
!Recordings.
!Patient Data Transfer (via PC Card or Network).
!Wireless Network Operation.
Page 1-8Infinity Gamma SeriesVF4
Overview
The monitor Gamma has a 6.5”, the monitor Gamma XL an 8”
color display. Both monitors have a rechargeable battery. A universal AC adapter is available for connection to a hospital- grade
outlet.
When used as a stand-alone device, you can connect the following peripheral equipment to the monitor via the monitor’s interface plate:
!An R50 Series recorder for printing alarm data, waveforms,
trends, and diagnostic logs.
!A nurse call system for broadcasting life-threatening, serious,
and advisory alarms.
!A VGA remote display for viewing monitoring data on a
larger screen.
For exporting data to external devices, the monitor provides a fast
synchronization output (i.e. for defibrillators) and an RS232 connector (via an interface plate or an Infinity Docking Station/CPS
Communication Power Supply).
When operating within the Infinity network, the monitor communicates with other network devices and with the M
ORKSTATION™ (central station), allowing central monitoring of
W
bedside data.
ULTIVIEW
For more information on network operation, refer to the chapter
Network Application.
You can transfer patient data between monitors with the help of a
Data Memory PC Card or via the network. For information on
data transfer, see the chapter Admission, Transfer, Discharge.
VF4Infinity Gamma SeriesPage 1-9
Front Panel
1
2
3
4
1) Alarm Light
2) Fixed Keys
3) Rotary Knob
4) Power ON/OFF Key
Page 1-10Infinity Gamma SeriesVF4
Back Panel
Overview
12
1) Power Supply Connection
2) Battery Compartment Cover
VF4Infinity Gamma SeriesPage 1-11
Left Side Panel
1
2
3
4
1) NBP Hose Connection
2) M
ULTIMED/NEOMED Connection
3) Invasive Blood Pressure Connection
4) PodPort (optional etCO
Page 1-12Infinity Gamma SeriesVF4
Pod Connection)
2
Right Side Panel
Overview
1
2
3
1) Carrying Handle
2) Memory Card Slot
3) QRS Sync. Output
VF4Infinity Gamma SeriesPage 1-13
Interface Plate (optional)
1
2
1) X5: External VGA/Scio Multigas Module
2) X7: Alarm Output/R50 Recorder/RS232
Page 1-14Infinity Gamma SeriesVF4
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