infinity_gamma_series_v6-0_instructions_for_use_.pdf
Page 1
Infinity Configured Monitoring Series
Infinity Gamma Series
Instructions for Use
Page 2
Manufactured by:
Draeger Medical Systems, Inc.
16 Electronics Avenue
Danvers, MA 01923
USA
Authorized EC representative:
Dräger Medical AG & Co. KG
Moislinger Allee 53-55
23558 Lübeck
Germany
Infinity Gamma Series Instructions for Use
Software Version VF5
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. KG, 2005.
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.
KG.
All Dräger devices are intended for use
by qualified medical personnel only.
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.
This device is subject to EU Directive
2002/96/EC (WEEE). It is not registered
for use in private households, and may
not be disposed of at municipal
collection points for waste electrical and
electronic equipment. Dräger Medical
has authorized a firm to dispose of this
device in the proper manner: for more
detailed information, please contact your
local Dräger Medical organization.
ACE, MultiMed, NeoMed, MultiView
WorkStation, Infinity, Infinity Docking
Station and Infinity Network are
registered trademarks of Dräger Medical
AG & Co. KG.
CAPNOSTAT is a registered trademark
of Novametrix Medical Systems, Inc.
Masimo, Masimo SET and Signal
Extraction Technology (SET) are
registered trademarks of Masimo
Corporation.
CAUTION: Federal Law in the United States restricts these devices to sale by, or on
the order of a physician.
ii
Gamma/Gamma XL
VF6
Page 3
INSTRUCTIONS FOR USE
Infinity Gamma Series Software Release Notes
Software Version VF6
!
Wireless network operation requires special configurations of the monitoring
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 station,
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 bedside monitor to the central viewport.
!
When you change the units of measure at the bedside monitor and the central
station 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 MULTIVIEW Telemetry System (VE0) is ST lead I and II,
regardless of the ST leads selected on the Infinity Gamma Series monitor.
Note: Other ST data is 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.
VF6
!
NBP parameter values transferred from an Infinity Gamma Series monitor to
an Infinity Delta Series monitor are 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.
!
When power-cycling the monitor or admitting a new patient, saved
monitoring settings may occasionally return to default settings. Check
monitoring settings after these events.
!
If the Scio module is unable to measure the concentration of N2O, the monitor
may enter the error code *A* (artifact) instead of *F* (failure) into the trend
storage.
Gamma/Gamma XL
iii
Page 4
iv
!
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 the values of an anesthetic agent exceed the measuring range, the
monitor displays +++ in the agent parameter box and cycles two out-of-range
error messages, one correctly identifying the agent with out-of-range values,
the other showing a previously monitored agent.
!
If two wireless bedside monitors are given the same bed label or IP address
during manual network configuration (a Biomed function), their connection to
the central station alternates between online/offline. In this case, change one
monitor’s bed label in the Admit menu or contact your Biomed technician to
change one monitor’s IP address, if necessary..
!
During zeroing of the Scio Multigas Module, the monitor sounds a false apnea
alarm when the following is true: Respiration alarms are ON, the respiration
rate was zero just before the start of Scio zeroing and the apnea time expires
before Scio zeroing is complete.
!
When you change parameter colors at a networked bedside monitor, the
monitor temporarily goes offline at the central station in order for the color
change to take effect.
!
If the monitor reports a Multigas hardware failure, displayed Multigas
parameter values might not be accurate. In this case, contact your Biomedical
Engineering department.
Gamma/Gamma XL
VF6
Page 5
INSTRUCTIONS FOR USE
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 R N I N G : A w a r n i n g c o n ta i n s i m p o r ta n t i n f o r m a t i o n
r e g a r d i n g p o s s i b l e d an g e r t o y o u o r t h e pa t i e n t t h a t i s
p re s e n t d u r i n g n o r m a l o p e r a t i o n o f t h e e q u i p m e n t .
Applicability
NOTE: Software functionality is identical between the following products, unless
otherwise noted:
!
Infinity Gamma XL = SC 6802XL
NOTE: The hardware of SC 6000 series monitors differs from Gamma series
monitors as follows:
!
SC 6000 series monitors do not have external alarm lights
VF6
!
SC 6000 series monitors do not have a USB connector
!
The Fast Access fixed key on SC 6000 series monitors is called Zoom
!
SC 6000 series monitors have a different size and weight (see Technical Data)
Gamma/Gamma XL
v
Page 6
Chapter Overview
Chapters
Overview.................................................................................................... 1
Monitor Setup............................................................................................ 2
Network Applications ............................................................................... 3
Admission, Discharge, Transfer.............................................................. 4
Alarms and Messages .............................................................................. 5
Trends ........................................................................................................ 6
Recordings ................................................................................................ 7
ECG and Heart Rate.................................................................................. 8
Arrhythmia................................................................................................. 9
ST-Segment Analysis ............................................................................. 10
Respiration .............................................................................................. 11
Pulse Oximetry........................................................................................ 12
End-Tidal CO2 ......................................................................................... 13
Multigas ................................................................................................... 14
Non-Invasive Blood Pressure................................................................ 15
Invasive Blood Pressure ........................................................................ 16
Temperature ............................................................................................ 17
Appendices
Options and Accessories........................................................................ A
Cleaning, Disinfecting, Sterilizing.......................................................... B
Default Settings and Biomedical Support ............................................. C
Technical Data.......................................................................................... D
Glossary
Index
vi
Gamma/Gamma XL
VF6
Page 7
INSTRUCTIONS FOR USE
Table of Contents
Infinity Configured Monitoring Series....................................................................... i
Infinity Gamma Series Software Release Notes
Software Version VF6 ............................................................................................ iii
Documentation Features ................................................................................................. v
Notes, Cautions, Warnings ....................................................................................... v
Applicability................................................................................................................ v
Chapter Overview ............................................................................................................ vi
Table of Contents ........................................................................................................... vii
CHAPTER 1: Overview
Important General Safety Considerations...................................................................1-2
Intended Use............................................................................................................1-3
Electromagnetic Compatibility ..............................................................................1-3
Reducing EMI ..........................................................................................................1-3
Site of Operation .....................................................................................................1-3
Electrical Safety ......................................................................................................1-4
Connections to Peripheral Devices.......................................................................1-4
Safety, Inspection, and Maintenance ....................................................................1-5
Electrosurgery and Defibrillation Safety...............................................................1-6
Pacemaker Safety ...................................................................................................1-6
Device Markings......................................................................................................1-7
General Description ......................................................................................................1-8
Front Panel...................................................................................................................1-10
Back Panel ...................................................................................................................1-11
Left Side Panel.............................................................................................................1-12
Right Side Panel ..........................................................................................................1-13
Interface Plate (optional).............................................................................................1-14
Gamma/Gamma XL Display........................................................................................1-15
Alarm Colors..........................................................................................................1-15
Parameter Colors ..................................................................................................1-16
Rotary Knob .................................................................................................................1-17
Fixed Keys....................................................................................................................1-18
Menus ...........................................................................................................................1-19
Power Sources.............................................................................................................1-20
MultiMed/NeoMed Pod ................................................................................................1-21
etCO2 Pod and Multigas Module................................................................................1-22
Recorder.......................................................................................................................1-22
Remote Displays..........................................................................................................1-23
Complete Menu Structure...........................................................................................1-23
VF6
Gamma/Gamma XL
vii
Page 8
CHAPTER 2: Monitor Setup
Getting Started...............................................................................................................2-2
Using the AC Adapter .............................................................................................2-2
Using the Battery ....................................................................................................2-3
Assembling MultiMed and NeoMed Pods .............................................................2-8
Starting the Monitor ......................................................................................................2-9
Main Screen Configuration.........................................................................................2-10
Waveform Selection..............................................................................................2-10
Bottom Channel Display ......................................................................................2-11
OR Mode ................................................................................................................2-14
Show Respiration or etCO2 Parameters .............................................................2-14
Setting the Master Speaker Volume ..........................................................................2-16
Standby ........................................................................................................................2-17
Saving Setups..............................................................................................................2-18
CHAPTER 3: Network Applications
Overview.........................................................................................................................3-2
Network Configurations................................................................................................3-3
Basic Network Components ..................................................................................3-4
Basic Bedside Setups ............................................................................................3-5
Network Operation ........................................................................................................3-6
Docking Station.......................................................................................................3-7
Docking and Undocking .........................................................................................3-9
Wireless Network Configuration..........................................................................3-10
Wireless Network Operation ................................................................................3-11
Network Safety Considerations .................................................................................3-14
Alarm and Status Messages.......................................................................................3-15
CHAPTER 4: Admission/Discharge/Transfer
Overview.........................................................................................................................4-2
Patient Admission .........................................................................................................4-2
Admit Menu .............................................................................................................4-3
Patient Category .....................................................................................................4-3
Name and ID ............................................................................................................4-5
Admit Date ...............................................................................................................4-6
Patient Discharge ..........................................................................................................4-6
Data Transfer .................................................................................................................4-8
Transfer Across the Network .................................................................................4-9
Transfer with a Data Memory PC Card................................................................4-10
viii
Gamma/Gamma XL
VF6
Page 9
INSTRUCTIONS FOR USE
CHAPTER 5: Alarms and Messages
Alarm Grades .................................................................................................................5-2
Life-Threatening Alarms.........................................................................................5-2
Serious Alarms........................................................................................................5-3
Advisory Alarms......................................................................................................5-3
Alarm Settings ...............................................................................................................5-4
Setting Alarm Limits ...............................................................................................5-5
Turning Parameter Alarms On/Off.........................................................................5-7
Turning Alarm Recordings On/Off.........................................................................5-8
External Alarm Lights .............................................................................................5-8
Alarm Validation ............................................................................................................5-9
Silencing Alarms .........................................................................................................5-10
Alarm Silence Key.................................................................................................5-10
All Alarms OFF Key...............................................................................................5-11
Assigning Alarm Groups ............................................................................................5-11
Central Alarms .............................................................................................................5-13
Alarms in OR Mode .....................................................................................................5-14
Messages .....................................................................................................................5-15
CHAPTER 6: Trends
Overview.........................................................................................................................6-2
Trend Setup....................................................................................................................6-2
Trend Graphs .................................................................................................................6-3
Trend Table ....................................................................................................................6-5
Special Conditions and Codes.....................................................................................6-6
CHAPTER 7: Recordings
Overview.........................................................................................................................7-2
Recorder Preparation....................................................................................................7-3
Assigning Network Recorders .....................................................................................7-5
Recording Waveforms ..................................................................................................7-6
Timed Recordings...................................................................................................7-6
Continuous Recordings .........................................................................................7-7
Recording Formats .................................................................................................7-7
Recording Trends..........................................................................................................7-9
Recording Alarms........................................................................................................7-11
Stored Recordings ......................................................................................................7-12
Event Recall...........................................................................................................7-12
Saving, Printing, Deleting Stored Recordings ...................................................7-13
Recording Status Messages.......................................................................................7-14
VF6
Gamma/Gamma XL
ix
Page 10
CHAPTER 8: ECG and Heart Rate
Overview.........................................................................................................................8-2
Patient Preparation........................................................................................................8-2
Selecting and Preparing the Electrodes ...............................................................8-2
Preparing the Patient’s Skin ..................................................................................8-3
Positioning the Electrodes.....................................................................................8-4
ECG Monitoring Settings ..............................................................................................8-7
Cable Type ...............................................................................................................8-7
Lead Selection and Display Amplitude .................................................................8-8
Cascade Display .....................................................................................................8-9
One- or Two-Channel Signal Processing............................................................8-10
Pulse Tone Source................................................................................................8-11
Pulse Tone Volume ...............................................................................................8-12
Pacer Detection .....................................................................................................8-13
Displaying Sync Marks .........................................................................................8-14
ECG and HR Safety Considerations ..........................................................................8-15
HR Alarm Settings ................................................................................................8-15
Neonatal ECG Monitoring ....................................................................................8-16
ECG 50/60 Hz Notch Filter Setting.......................................................................8-16
Muscle Stimulators ...............................................................................................8-16
Electrosurgery (ESU) ............................................................................................8-16
Infusion pumps .....................................................................................................8-18
Defibrillators and Cardioversion .........................................................................8-18
High P-Waves and T-Waves .................................................................................8-18
Pacemakers ...........................................................................................................8-19
AV Sequential or DDD Pacemakers ....................................................................8-20
Pacemakers with Impedance-Derived Rate Response......................................8-20
Large Amplitude Pacer Pulses ............................................................................8-20
Transcutaneous Electrical Nerve Stimulators (TENS).......................................8-21
CHAPTER 9: Arrhythmia
Overview.........................................................................................................................9-2
Turning Arrhythmia Monitoring ON .............................................................................9-4
Arrhythmia Setup ..........................................................................................................9-5
Rate and Count .......................................................................................................9-6
Arrhythmia Alarms..................................................................................................9-6
Arrhythmia Alarm Recordings ...............................................................................9-6
Relearning a Patient’s ECG ..........................................................................................9-7
x
Gamma/Gamma XL
VF6
Page 11
INSTRUCTIONS FOR USE
CHAPTER 10: ST Segment Analysis
Overview.......................................................................................................................10-2
ST Monitoring Display.................................................................................................10-3
ST Setup .......................................................................................................................10-4
Isoelectric and ST Measuring Points ..................................................................10-4
ST Reference Complex .........................................................................................10-6
ST Alarms.....................................................................................................................10-7
CHAPTER 11: Respiration Monitoring
Overview.......................................................................................................................11-2
Patient Preparation......................................................................................................11-2
Selecting and Preparing the Electrodes .............................................................11-2
Preparing the Patient’s Skin ................................................................................11-2
Electrode Placement for Respiration Monitoring...............................................11-3
Respiration Monitoring Display .................................................................................11-4
Displaying Respiration Data ................................................................................11-4
Rsp Display Channel ............................................................................................11-5
Resp Display Amplitude .......................................................................................11-6
Respiration Monitoring Settings ................................................................................11-7
Rsp Mode ...............................................................................................................11-7
Resp Markers.........................................................................................................11-8
Apnea Time............................................................................................................11-8
Coincidence Alarm................................................................................................11-9
Relearning a Patient’s Respiration Pattern ......................................................11-10
Rsp Safety Considerations.......................................................................................11-11
OxyCRG Monitoring (Neonatal Option) ...................................................................11-12
Displaying OCRG Waveforms............................................................................11-12
OCRG Recordings...............................................................................................11-14
CHAPTER 12: Pulse Oximetry
Overview.......................................................................................................................12-2
Connections.................................................................................................................12-3
Sensor Application......................................................................................................12-4
SpO2 Safety Considerations ......................................................................................12-5
SpO2 Monitoring Display............................................................................................12-6
SpO2 Display Channel..........................................................................................12-6
SpO2 Display Amplitude ......................................................................................12-7
Cascade Display....................................................................................................12-7
SpO2 Monitoring Settings ..........................................................................................12-8
Pulse Tone Source................................................................................................12-8
Pulse Tone Volume ...............................................................................................12-9
Signal Strength Bar Graph .................................................................................12-10
Averaging Mode ..................................................................................................12-11
VF6
Gamma/Gamma XL
xi
Page 12
CHAPTER 13: End-Tidal CO2
Overview.......................................................................................................................13-2
etCO2 Source...............................................................................................................13-3
etCO2 Display ..............................................................................................................13-4
Monitoring Preparations .............................................................................................13-6
Connecting Sensor and etCO2 Pod ....................................................................13-6
Attaching the Capnostat and Airway Adapter....................................................13-6
Calibrating the Sensor and Adapter..................................................................13-10
etCO2 Monitoring Settings .......................................................................................13-12
Averaging Mode ..................................................................................................13-12
RRc Apnea Time .................................................................................................13-12
Balance ................................................................................................................13-13
Measuring Mode..................................................................................................13-14
Anesthetic Agent Compensation.......................................................................13-15
Atmospheric Pressure Compensation..............................................................13-15
etCO2 Alarms.............................................................................................................13-17
CHAPTER 14: Multigas
Overview.......................................................................................................................14-2
Connections.................................................................................................................14-2
The Scio Module ..........................................................................................................14-5
Types of Modules..................................................................................................14-6
Site of Operation ...................................................................................................14-9
Installing/Removing the Water Trap..................................................................14-10
Connecting Sampling Lines and Power Cord ..................................................14-10
Warm-Up ..............................................................................................................14-13
OR Mode.....................................................................................................................14-14
Parameter Display...............................................................................................14-16
CO2 Display and Setup ......................................................................................14-17
Multigas Display and Setup ...............................................................................14-18
End Case and Standby .......................................................................................14-21
CHAPTER 15: Non-Invasive Blood Pressure
Overview.......................................................................................................................15-2
Cuff Selection and Placement ....................................................................................15-3
NBP Safety Considerations .................................................................................15-5
NBP Measurements.....................................................................................................15-6
Single Measurements ...........................................................................................15-6
Interval Mode .........................................................................................................15-6
Inflation Mode........................................................................................................15-8
Measurement Tone ...............................................................................................15-9
NBP Measurements in OR Mode..............................................................................15-10
NPB Alarms................................................................................................................15-11
xii
Gamma/Gamma XL
VF6
Page 13
INSTRUCTIONS FOR USE
CHAPTER 16: Invasive Blood Pressure
Overview.......................................................................................................................16-2
Invasive Pressure Labels............................................................................................16-3
IBP Display...................................................................................................................16-3
Display Channel and Waveform Amplitude........................................................16-4
Selecting and Preparing the Transducer ..................................................................16-5
Zeroing and Calibration Check ............................................................................16-6
Zero and Calibration Check Troubleshooting ....................................................16-7
Calibrating Reusable Transducers......................................................................16-8
CHAPTER 17: Temperature
Overview.......................................................................................................................17-2
Temperature Probes....................................................................................................17-2
Placing the Probe..................................................................................................17-2
APPENDIX A: Options and Accessories
Options .......................................................................................................................... A-2
MultiMed/NeoMed Pods ............................................................................................... A-2
ECG................................................................................................................................ A-3
Pulse Oximetry (SpO2)................................................................................................. A-5
End Tidal CO2 (etCO2) ................................................................................................. A-8
Multigas ......................................................................................................................... A-9
Temperature................................................................................................................ A-10
Invasive Blood Pressure (IBP) .................................................................................. A-11
Non-invasive Blood Pressure (NBP)......................................................................... A-12
Power Sources............................................................................................................ A-12
Displays and Display Components........................................................................... A-14
Recorder...................................................................................................................... A-15
Miscellaneous ............................................................................................................. A-15
APPENDIX B: Cleaning and Disinfecting
Cleaning and Disinfecting ........................................................................................... B-2
Monitor .................................................................................................................... B-2
Patient Cables ........................................................................................................ B-2
Reusable ECG Electrodes ..................................................................................... B-2
Reusable SpO2 Sensor.......................................................................................... B-3
NBP Cuff ................................................................................................................. B-3
Temperature probes and cables........................................................................... B-3
Reusable Pressure Transducers and Cables ...................................................... B-4
Masimo SET SpO2 Pod ................................................................................................ B-4
etCO2 Pod and Accessories........................................................................................ B-5
VF6
Gamma/Gamma XL
xiii
Page 14
Capnostat Sensor .................................................................................................. B-5
ReusableAirway Adapters..................................................................................... B-5
Nasal Sampling Cannulas and Tubing................................................................. B-5
Sidestream Sampling Pump ................................................................................. B-5
Scio Module and Accessories..................................................................................... B-8
Emptying the Water Trap ...................................................................................... B-8
Cleaning/Replacing the Fan Filter ........................................................................ B-9
APPENDIX C: Default Settings and Biomedical Support
Default Settings ............................................................................................................ C-2
Biomedical Support.................................................................................................... C-11
Startup Tests ........................................................................................................ C-11
Checking the NBP Calibration ............................................................................ C-12
Biomed Menu ....................................................................................................... C-13
Saving a Patient Setup ........................................................................................ C-14
Locked Options and Demo Mode ....................................................................... C-14
Diagnostic Logs ................................................................................................... C-15
Changing Units of Measure ................................................................................ C-16
Turning External Alarm Lights ON/OFF ............................................................. C-17
Parameter Colors ................................................................................................. C-18
NBP/SpO2 Interlock ............................................................................................. C-19
ASY/VF Alarms ..................................................................................................... C-19
Pacer Mode ........................................................................................................... C-20
APPENDIX D: Technical Data
Overview........................................................................................................................ D-2
Regulatory Compliance ......................................................................................... D-2
Basic System Components................................................................................... D-3
Monitoring Accessories ........................................................................................ D-9
Monitoring Specifications ................................................................................... D-12
Electromagnetic Compatibility.................................................................................. D-23
Glossary
Index
xiv
Gamma/Gamma XL
VF6
Page 15
1 Overview
Important General Safety Considerations...................................................................1-2
Intended Use............................................................................................................1-3
Electromagnetic Compatibility ..............................................................................1-3
Reducing EMI ..........................................................................................................1-3
Site of Operation .....................................................................................................1-3
Electrical Safety ......................................................................................................1-4
Connections to Peripheral Devices .......................................................................1-4
Safety, Inspection, and Maintenance ....................................................................1-5
Electrosurgery and Defibrillation Safety...............................................................1-6
Pacemaker Safety ...................................................................................................1-6
Device Markings ......................................................................................................1-7
General Description.......................................................................................................1-8
Front Panel ...................................................................................................................1-10
Back Panel....................................................................................................................1-11
Left Side Panel .............................................................................................................1-12
Right Side Panel ..........................................................................................................1-13
Interface Plate (optional).............................................................................................1-14
Gamma/Gamma XL Display ........................................................................................1-15
Alarm Colors..........................................................................................................1-15
Parameter Colors ..................................................................................................1-16
Rotary Knob .................................................................................................................1-17
Fixed Keys....................................................................................................................1-18
Menus ...........................................................................................................................1-19
Power Sources.............................................................................................................1-20
MultiMed/NeoMed Pod ................................................................................................1-21
etCO2 Pod and Multigas Module................................................................................1-22
Recorder .......................................................................................................................1-22
Remote Displays..........................................................................................................1-23
Complete Menu Structure ...........................................................................................1-23
Page 16
1 OVERVIEW
Important General Safety Considerations
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 R N I N G : M o n i t o r o p e r a t i o n is c u r r e n t l y n o t s u p p o r t e d i n
t h e f o l l o w i n g e n v i r o n m e n ts : m a g n e t i c r e s o n a n c e i m a g i n g
( M R I ) , a i r c r a ft , a m b u l a n c e , h o m e o r h y p e rb a ri c c h a m b e r
e n v i r on me n ts .
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.
1-2
Gamma/Gamma XL
VF6
Page 17
IMPORTANT GENERAL SAFETY CONSIDERATIONS
Intended Use
The Infinity Gamma series monitor is intended for use on adult, pediatric and neonatal
patients where physiological patient monitoring is indicated. The use of the monitor is
restricted to one patient at a time.
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.
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 monitoring and/or lifesupport 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.
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 R N I N G : D o n o t o p e r a t e t h e m o n i t o r i n p r e s e n c e o f
f l a mm a b l e a n e s t h e t i c m i x t u r e s w i t h a i r, o x y g e n , o r n i t r o u s
oxide. Do not use the monitor near devices with microwave or
o t h e r h i g h f r e q u e n c y e mi s s i o n s t h a t m a y i n t e r f e r e w i t h t h e
m o n i t o r ’s o p e r a t i o n .
VF6
Gamma/Gamma XL
1-3
Page 18
1 OVERVIEW
WA R N I N G : I f f l u i d s a r e a c c i d e n ta l l y s p i l l e d o n t h e m o n i t o r, i t
s h o u l d b e r e m o v e d f r o m s e r v i c e i m m e d i a t e l y a n d t h o ro u g h l y
i n s p e c t e d b y y o u r B i o m e d t o e ns ure t ha t t he re i s no
c o m p r o m i s e i n e l e c t r i c a l s a f e t y.
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.
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, hospitalgrade outlet with proper grounding.
WA R N I N G : D r ä g e r d e v i c e s a r e n o t i n t e n d e d f o r u s e i n a r e a s
w h e r e t h e r e i s a d a n g e r o f e x p l o s i o n . I f t h e d e v i c e s a re u s e d
w h e r e f l a m m a b l e a n e s t h e t i c s u b s ta n c e s a r e u s e d , t h e
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.
1-4
Gamma/Gamma XL
VF6
Page 19
IMPORTANT GENERAL SAFETY CONSIDERATIONS
Safety, Inspection, and Maintenance
WA R N I N G : B e c a u s e o f t h e d a n g e r o f e l e c t r i c s h o c k , n e v e r
remove the cover of any device while in operation or
c o n n e c t e d t o a p o w e r o u t l e t v i a t h e A C a d a pt e r.
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.
Do not use cables that appear cracked, worn or damaged. Use of such cables may
contribute to poor monitoring performance or cause the display of erroneous values.
Leakage current 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.
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 lasts
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 from line or lead acid/lithium ion battery power, the capacity of the
internal battery is drained in approximately three years.
VF6
Gamma/Gamma XL
1-5
Page 20
1 OVERVIEW
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 R N I N G : T h e m o n i t o r i s n o t p r o t e c t e d a g a i n s t h i g h frequency 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 SpO2 pulse rate instead of the ECG to determine the 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.
Pacemaker Safety
WA R N I N G : R a t e m e t e r s m a y c o n t i n u e t o c o u n t t h e pa c e m a k e r
r a t e d ur i n g o c c u r r e n c e s o f c a r d i a c a r r e s t o r s o m e
a r r h y t h m ia s . D o n o t r e l y e n t i r e l y u p o n r a t e m e t e r a l a r m s .
K e e p pa c e m a k e r pa t i e n ts u n d e r c l o s e s u r v e i l l a n c e .
WA R N I N G : M a k e s u r e t h a t pa c e r d e t e c t i o n i s t u r n e d o f f f o r
pa t i e n ts w i t h o u t pa c e m a k e r s , a nd t u r n e d o n f o r pa t i e n ts w i t h
pa c e m a k e r s .
1-6
Gamma/Gamma XL
VF6
Page 21
IMPORTANT GENERAL SAFETY CONSIDERATIONS
Device Markings
#
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.
"
)
0123
This device bears the ) label in accordance with the provisions of the
Directive 93/42/EEC of 14June 1993 concerning medical devices.
IPX1
Protected against harmful effects of dripping water.
NBP
Non-Invasive Blood Pressure.
IBP
Invasive Blood Pressure.
Waste Electrical and Electronic Equipment (WEEE) disposal requirements.
VF6
Gamma/Gamma XL
1-7
Page 22
1 OVERVIEW
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 PICK AND GO™ 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 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.
!
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.
The monitor Gamma has a 6.5”, the monitor Gamma XL an 8.4” color display. Both
monitors have a rechargeable battery. A universal AC adapter is available for
connection to a hospital- grade outlet.
1-8
Gamma/Gamma XL
VF6
Page 23
GENERAL DESCRIPTION
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 MULTIVIEW WORKSTATION™ (central station), allowing
central monitoring of bedside data.
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.
VF6
Gamma/Gamma XL
1-9
Page 24
1 OVERVIEW
Front Panel
1
2
1-10
Alarm Light
3
Rotary Knob
Fixed Keys
4
Power ON/OFF Key
(not available on SC 6002/6802XL)
Gamma/Gamma XL
VF6
Page 25
BACK PANEL
Back Panel
1
VF6
Power Supply Connection
2
Battery Compartment Cover
Gamma/Gamma XL
1-11