Astro Med PSGBASE PSG Base physiological signal recording User Manual AURA title

Astro-Med, Inc. PSG Base physiological signal recording AURA title

User Manual

Download: Astro Med PSGBASE PSG Base physiological signal recording User Manual AURA title
Mirror Download [FCC.gov]Astro Med PSGBASE PSG Base physiological signal recording User Manual AURA title
Document ID611902
Application IDBmGjW4K8mD252C3YSTXgeg==
Document DescriptionUser Manual
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeUser Manual
Display FormatAdobe Acrobat PDF - pdf
Filesize100.87kB (1260842 bits)
Date Submitted2005-12-15 00:00:00
Date Available2005-12-15 00:00:00
Creation Date2005-11-04 13:37:49
Producing SoftwareAcrobat Distiller 5.0.5 for Macintosh
Document Lastmod2005-11-04 13:38:10
Document TitleAURA title
Document CreatorAdobe PageMaker 7.0

GRASS-TELEFACTOR
AURA PSG
®
WIRELESS /AMBULATORY RECORDER
WITH
AURAPSG AMPLIFIER SYSTEM
USERS MANUAL
Release A
®
600 East Greenwich Avenue, West Warwick, RI 02893
Phone 401.828.4000 • Fax 401.822.2430 • Technical Support 877.472.7779 • E-mail grass-telefactor@astromed.com
Web site: www.grass-telefactor.com
Manual Part Number M636K05
© COPYRIGHT 2005
ASTRO-MED, INC.
This manual is copyrighted with all rights reserved. No part of this manual
may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translated into any language in any form by any means without written
permission of Grass-Telefactor, An Astro-Med, Inc. Product Group.
Information in this document is subject to change without notice. Astro-Med,
Inc. assumes no responsibility for any errors, omissions or inaccuracies
whatsoever. The software described in this document is furnished under a
software license agreement. The software may be used only in accordance
with the terms of this agreement. Except as permitted by the software license
agreement, no part of this software may be reproduced, transmitted,
transcribed, stored in a retrieval system, or translated into any language, in
any form or by any means, electronic, mechanical, magnetic, optical, chemical,
or manual, including photocopying, anywhere in the world without the
written permission of Astro-Med, Inc.
TRADEMARKS
AURA®, Aurora®, Beehive®, Beehive Millennium®, Brain Navigator®,
BrainTree®, Comet®, EZM®, EC2®, FASS™, Gamma®, GrassLab®, Heritage®,
H2O®, Panorama®, PolyVIEW®, SAFELEAD®, SleepTrek®, Sonoma®, SzAC®,
TWin® and TWinLOOK® are trademarks of Astro-Med, Inc.
CompactFlash® is a trademark of SanDisk Corporation.
Windows® is a trademark of Microsoft Corporation.
Bluetooth™ is a trademark of Bluetooth SIG, Inc.
PureLight® is a trademark of Nonin Medical, Inc.
Other brand and product names are trademarks or registered trademarks of
their representative holders.
Printed in the United States of America
AMPLIFIER SYSTEM IDENTIFICATION DATA
Congratulations. Your Grass-Telefactor purchase is an investment in the finest of
state-of-the-art medical technology. The information provided below lists the model
number and serial number of your Amplifier system. If, for any reason, it should be
necessary for you to contact Astro–Med, Inc. regarding your purchase, please refer to
the following:
Amplifier Serial Number: ______________________
Base Station Serial Number:______________________
IMPORTANT
This manual is subject to periodic review, update, and revision. Customers are
cautioned to verify that the manual’s information applies to the software and
hardware present in the equipment.
This product performs as described in this manual, and in accompanying labels
and/or inserts, when assembled, operated, maintained, and repaired in accordance
with the instructions provided.
This product must be cleaned and checked periodically. Do not use a defective
product. Parts that are broken, missing, worn, or contaminated should be replaced
immediately. If repair or replacement becomes necessary, call or write to request
service advice from Grass-Telefactor.
This product must not be altered without the prior written approval of
Grass-Telefactor. The user of this product shall have the sole responsibility for any
malfunction that results from improper use, faulty maintenance, improper repair,
unauthorized service, or alteration by anyone other than Grass-Telefactor.
The safety, reliability, and performance of this device can only be assured under the
following conditions:
• If the device has been used according to the accompanying
operating instructions.
• If changes or repairs have been carried out by Grass-Telefactor.
• If it is used in buildings having ground equalization wiring that complies
with relevant UL, CSA, IEC or other local standards and regulations.
REGULATORY NOTICES
This device has been designed and certified to comply with the requirements
of the international standard EN60601-1 and EN60601-2-26, EN60601-1-2, and
EN60601-1-1 the United States standard UL 60601-1, and the Canadian
standard CAN/CSA22.2 No.601.1.
The device is classified:
CLASS I, Type BF
100-250 VAC, 50/60 Hz, 80 VA
The above classification is based on the condition that this device is installed
and configured according to the instructions supplied. In order for the
complete system to maintain compliance with the relevant standards, the host
computer must be approved to the IEC950 standard.
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more
of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including
interference that may cause undesired operation.
EQUIPMENT CLASSIFICATIONS
Shock Prevention: Class 1
Degree of Protection Against Harmful Ingress of Water: Ordinary Equipment, IPX0
Degree of Safety in the Presence of Flammable Anesthetic Mixture with Air or with
Oxygen or Nitrous Oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Mode of Operation: Continuous
WARNINGS
ELECTRIC SHOCK HAZARD
Warning:
Warning:
Warning:
Warning:
Connect the Base Station Power Supply only to a three-wire,
grounded, hospital-grade receptacle. The three-connector plug
must be inserted into a properly wired three-wire receptacle. If a
three-wire receptacle is not available, a qualified electrician must
install one in accordance with the governing electrical code.
Do not use extension cords or adaptors of any kind. The power
cord and plug must be intact and undamaged.
The appliance coupler (AC Cordset) is the means for
disconnecting the Base Station from the power mains.
Measure the system’s leakage current after completion of
installation, after disconnect/reconnection of parts of the system,
and at regular periodic intervals. For instructions on how to
perform this test please contact Grass-Telefactor Technical
Support. Forward and reverse polarity: 500 microamperes
maximum.
EXPLOSION HAZARD
Warning:
Warning:
Do not use this system in the presence of flammable anesthetics
or other flammable substances.
Use only the specified battery (part number 26759200) in the
AURA PSG Amplifier. Use of unauthorized battery may cause
explosion/fire hazard.
PATIENT SAFETY
Warning: The patient should be disconnected from the AURA PSG system
when high frequency surgical equipment is used.
Warning: This system should not be used in place of electrocardiograph for
vital signs monitoring.
Warning: Use only by or on the order of medically trained personnel.
Warning: Battery Charger must not be located in a patient area.
Warning: Do not use in an MRI environment.
Warning: Read manual before using.
Warning: Protect from exposure to liquids. If the Amplifier Unit is exposed to
liquids during recording, discontinue use by disconnecting the
electrodes from the Amplifier Unit and turning the Amplifier Unit
power off. Resumption of recording is to be performed only by
qualified personnel.
Warning: AURA PSG contains no user serviceable parts.
Warning: AURA PSG is not intended to be sterilized.
Warning: Use only Nonin-manufactured PureLight® pulse oximeter sensors.
These sensors are manufactured to meet the accuracy specifications
for Nonin pulse oximeters. Using other manufacturers’ sensors can
result in improper pulse oximeter performance. A list of compatible
sensors is provided in CHAPTER 5: ACCESSORIES AND REPLACEMENT PARTS.
Warning: Loss of pulse oximeter monitoring can result if any objects hinder
the pulse measurement. Ensure that no blood flow restrictors (e.g.,
blood pressure cuff) hinder pulse measurements.
Warning: As with all medical equipment, carefully route cables and
connections to reduce the possibility of entanglement or
strangulation.
Warning: This pulse oximetry system is designed to determine the percentage
of arterial oxygen saturation of functional hemoglobin. Significant
levels of dysfunctional hemoglobin, such as methemoglobin, might
affect the accuracy of the measurement.
Warning: Inspect the pulse oximeter sensor application site at least every
6 to 8 hours to ensure correct sensor alignment and skin integrity.
Patient sensitivity may vary due to medical status or skin condition.
Discontinue use of adhesive tape strips if the patient exhibits an
allergic reaction to the adhesive material.
Warning: The accuracy of the SpO2 measurement may be affected if the total
pulse oximeter cable length (including extension cables) is greater
than 3 meters.
INTENDED USE
The AURA PSG amplifier system is intended for recording routine
electroencephalography (EEG) and polysomnography (PSG).
The device is intended to be used only by physicians, technicians, or other
medical professionals that are trained in electroencephalography or
polysomnography.
CAUTION
Federal law restricts this device to sale by or on the order of a licensed
physician (or properly licensed practitioner).
Use only the Nonin probes as the optional pulse oximeter.
Use only accessories and electrodes identified for use with this device
(see instructions for the electrodes that are being used).
Disconnect power supply before servicing.
Disconnect the AURA PSG before using a defibrillator.
The use of pulse oximeter accessories, sensors, and cables other than those
specified by Grass Telefactor may result in increased emission and/or
decreased immunity of this device.
The AURA PSG wireless mode uses the 2.4 GHz ISM band. Performance may
be impacted by other devices using this frequency, including Wi-Fi terminals,
Bluetooth PDAs and some cordless phones.
1
Specifications & Symbols Glossary
Specifications
AURA PSG SYSTEM SPECIFICATIONS
Amplifier __________ Grass-Telefactor AURA PSG system
13 referential electrode inputs
2 reference electrode inputs
7 differential inputs
2 DC coupled inputs
1 connection for a Nonin pulse-oximeter
AMPLIFIER SPECIFICATIONS
REFERENTIAL ELECTRODE INPUTS
Input Signal Range _
Input Impedance ___
Differential Input
Impedance _____
Amplitude Accuracy _
Frequency Response
Enhanced Low
Frequency
with TWin ______
CMR (60 Hz) _______
Noise ____________
Input Bias Current __
Cross-Talk ________
Maximum Input ____
4 mV peak to peak full-scale
12 Megohm or higher, all inputs including reference
20 Megohm or higher
±2.5 % (prior to software correction)
0.5 Hz to 50 Hz (-3 dB points, within 10%)
0.1 Hz (-3 dB, within 10%)
>80 dB (signal referenced) or >100 dB (earth reference)
<2 µV peak to peak
<4 nA
0.1% or less
4 mV
AURA® PSG Wireless/Ambulatory Recorder
1-1
DIFFERENTIAL INPUTS
Input Signal Range _
Input Impedance ___
Amplitude Accuracy _
Frequency Response
Enhanced Low
Frequency
with TWin ______
CMR (60 Hz) _______
Noise ____________
Input Bias Current __
Cross-Talk ________
Maximum Input ____
4 mV peak to peak full-scale
12 Megohm or higher
± 2.5 %
0.5 Hz to 50 Hz (-3 dB points, within 10%)
0.1 Hz (-3 dB, within 10%)
>80 dB (signal referenced) or >100 dB (earth reference)
<2 µV peak to peak
<350 nA
0.1% or less
4 mV
ISOLATED DC INPUTS
Input Signal Range _ ±2.0 V
Frequency Response 50 Hz (-3 dB points, within 10%)
Cross-Talk ________ 1% or less
Impedance
Test Mode ______
Calibration Signal __
Sampling Rate _____
Power ____________
Referential inputs only: 1 kohms to 100 kohms, 10%
Referential inputs only: 500 µV peak to peak ±2%
200 samples/second/channel
Rechargeable 3.6 V lithium battery
Capacity: 10 hours in the wireless mode, 12 hours in the
tethered mode
Charging: The battery must only be charged with the
external Grass-Telefactor 42050100 Battery Charger that
operates from a DC voltage supplied by the external
RPS-21903 Power Supply (see the separate Battery
Charger operating instructions)
Physical Size ______ Amplifier Unit approximately:
3.5" W x 5.9" H x 1.0" D (8.9 cm x 14.9 cm x 2.5 cm)
Weight: 10 ozs. (280 g)
1-2
Chapter 1 Specifications & Symbols Glossary
BASE STATION SPECIFICATIONS
NON-ISOLATED DC INPUTS
Input Signal Range _ ±2.5 V
Frequency Response 50 Hz (-3 dB points, within 10%)
Cross-Talk ________ 1 % or less
DC Channels ______ 2 channels
±2.5 V
Connectivity
to Host PC ______ Standard 10Base-T Ethernet, TCP/IP protocol
Power ____________ Medical-grade Isolated Power Supply
Physical Size ______ Base Station approximately:
7" W x 7.5" H x 2.7" D (17.8 cm x 19.1 cm x 6.9 cm)
Weight: 2.3 lbs. (1.04 kg)
BUILT-IN OXIMETER: USE ONLY WITH NONIN PURELIGHT SENSORS
Oximeter Saturation
Range _________ 0 to 100%
Pulse Rate Range __ 18 to 300 pulses per minute
Measurement
Wavelengths ____ Red: 660 nm at 3mW nominal
Infrared: 910 nm at 3mW nominal
Accuracy _________ SpO2 (70-100%) (±1SD*):
No Motion:
Adults, Pediatrics
Neonates
Motion:
Adults, Pediatrics
Neonates
Low Perfusion: Adults, Pediatrics
Neonates
Heart Rate:
No Motion (18-300 bpm):
Adults, Pediatrics, Neonates
Motion (40-240 bpm):
Adults, Pediatrics, Neonates
Low Perfusion (40-240 bpm):
Adults, Pediatrics, Neonates
±2 digits
±3 digits
±2 digits
±3 digits
±2 digits
±3 digits
±3 digits
±5 digits
±3 digits
* Standard Derivation is a statistical measure: up to 32% of the readings may fall outside these limits.
AURA® PSG Wireless/Ambulatory Recorder
1-3
OTHER SPECIFICATIONS
Regulatory ________ AURA PSG System: certified to
UL 60601-1
CAN/CSA C22.2 No. 601.1
IEC 60601-1-1
IEC 60601-2-26
EN 60601-1-2
CE marked to EC MDD (93/42/EEC)
Warranty __________ Lifetime Limited Warranty on Grass-Telefactor
manufactured parts (see our full warranty for details)
Software __________ Fully supported by TWin
RPSAS40 MEDICAL-GRADE POWER SUPPLY
Input _____________ 100 to 260 VAC
Line Frequency: 47 to 63 Hz
Ambient Operating Temperature: 0 to 40°C
IEC320 Power Inlet, Removable 8-foot (2.4 m)
Hospital-grade Cordset
Output ___________ +12 VDC Regulated, 1.2 Amperes maximum
Short Circuit Protected
Line/Load Regulation: ±5% Overall
Output Cable: 6 foot (1.8 m)
Agency Approvals __ Conforms to UL2601-1 and certified to
CAN/CSA C22.2 No.601.1,
Certified to IEC60601-1 and TUV601.1 approved
Physical Size ________ 3" W x 1.89" H x 4.75" L (7.6 cm x 4.8 cm x 12 cm)
Weight: 1 lb. (0.45 kg)
SYSTEM TRANSPORT OR STORAGE SPECIFICATIONS
Ambient Temperature
Range __________ -40° C to +70° C
Relative Humidity
Range __________ 10% to 100%, including condensation
Atmospheric
Pressure Range __ 500 hPa to 1060 hPa
(All specifications subject to change without notice.)
1-4
Chapter 1 Specifications & Symbols Glossary
GLOSSARY OF SYMBOLS
Direct Current
Courant Continu
On (only for a part of equipment)
Marche (seulement pour une partie de l’appareil)
Off (only for a part of equipment)
Arret (seulement pour une partie de l’appareil)
Attention, consult accompanying documents
Attention, consulter les documents d’accompagnement
Protective Earth
Terre de Protection
Isolated Inputs
Entrées Isolées
Non-ionizing electromagnetic radiation
Rayonnement électr
omagnétique non ionisant
AURA® PSG Wireless/Ambulatory Recorder
1-5
1-6
Chapter 1 Specifications & Symbols Glossary
2
Introduction
Product Description
The AURA PSG system is designed specifically for recording EEG and PSG.
The system features a compact, wearable 24-channel Amplifier Unit and a Base
Station that can be mounted in a variety of locations.
The AURA PSG system provides for patient safety isolation, signal
conditioning (physiological signal amplification and filtering), and digitization.
The host computer receives data according to a specific protocol.
Grass-Telefactor TWin® software can be used on the host computer to receive
and process the data. The TWin software is powerful and easy to use,
providing data acquisition, recording, and review capabilities in one flexible
package.
By combining over 70 years of neurophysiological amplifier experience with
the latest digital design techniques, the AURA PSG continues with the quality,
reliability, and simplicity that have made Grass-Telefactor famous in the field of
neurophysiology.
FEATURES
•
•
•
•
•
•
Compact design that is rugged, lightweight and easy to use
Local analog to digital conversion for interference-free recordings
Easily connect to any PC with the on-board Ethernet connection
Built-in impedance checking and calibrations
Amplifier Unit is wearable for ambulatory applications
Wireless mode allows ambulatory applications within 25 feet (without
obstructions) of the Base Station.
AURA® PSG Wireless/Ambulatory Recorder
2-1
AMPLIFIER UNIT
The unit is enclosed in a plastic housing approximately 3.5” W x 5.9” H x 1.0” D
(8.9 cm x 14.9 cm x 2.5 cm) in size. It is small and light enough to be worn
comfortably.
RE
RO
A1
EC
G+
CH
13
Ch
in3
Ch
in1
C3
O1
Sp
Pu 2
lse
rflo
Ai
or
Sn
RA
DC
PS R A
The Amplifier Unit provides 22 isolated, analog waveform inputs along with
two additional channels generated by a Nonin pulse oximeter. Electrode and
sensor connection is direct to the unit with no adaptor required.
Figure 2-1: Amplifier Unit
Following is a list of the analog inputs with connector type:
13 AC Referential
SAFELEAD electrode connection
1 AC Differential
Pair of SAFELEAD electrode connections
6 AC Differential
2-pin molded connectors
2 DC
2-pin molded connectors
There are also SAFELEAD electrode connections for two Ref inputs and one GND
(common). The Amplifier Unit can operate in either standard or wireless modes.
STANDARD MODE
The Amplifier Unit can be tethered to the Base Station, which streams data to a
host computer. When tethered, the Amplifier Unit connects to the Base Station via
a single cable that carries power and data through a proprietary serial interface.
The Amplifier Unit is also capable of operating un-tethered. When un-tethered,
it will run off a battery and save data on a CompactFlash® memory card.
WIRELESS MODE
The Amplifier Unit uses Bluetooth® technology to stream data to a host computer
via a wireless connection with the Base Station. The Amplifier Unit must be within
25 feet (without obstructions) of the Base Station. The Amplifier Unit is powered
by a battery and does not use a CompactFlash card or Tether Cable.
2-2
Chapter 2 Introduction
BASE STATION
The Base Station is enclosed in a plastic housing approximately 7” W x 6” H x
2” D (17.8 cm x 15.3 cm x 5.1 cm) in size and it can be attached to a cart arm,
mounted on a wall next to a patient bed, or sit flat on a tabletop.
AURA-PSG Base Station
Figure 2-2: Base Station
The Base Station converts data from the Amplifier Unit to network protocols
for transfer to a host computer. See CHAPTER 3 INSTALLATION, FIGURE 3-6.
The LCD display with menu controls is located on the top surface of the Base
Station. Menu selections can be made for configuring the unit, communicating
with the host computer, and implementing the electrode impedance test. The
LCD also displays status information such as electrode impedance test values.
A Tether Cable connection port is also located on the top surface of the Base
Station. This is used to connect the Amplifier Unit to the Base Station via the
Tether Cable in standard mode. The Base Station also contains Bluetooth
technology to receive data from the Amplifier Unit in wireless mode.
AURA® PSG Wireless/Ambulatory Recorder
2-3
Power is supplied to the Base Station through a rear side
connector that attaches to the RPSAS40 Medical-grade
Power Supply (+12 VDC). The RPSAS40 Power Supply
module provides low-voltage (+12 VDC) to power the
Base Station. Only certified Grass-Telefactor regulated
power supplies can be used with the AURA PSG system.
A 36-pin connector is also located on the rear side and it
allows for the connection of an optional Patient
Eventbutton (CAB-21648-10). Two Auxiliary DC inputs
are available for recording external voltage sources. All
other connections are also located on the rear side of the
Base Station.
Figure 2-3: RPSAS40
Power Supply
BATTERY & BATTERY CHARGER
A rechargeable 3.6 V lithium ion battery (267592000) provides power to the
Amplifier Unit. The Battery Charger is a free-standing unit that can charge a
single battery. The Battery Charger is external and operates from a DC voltage
supplied by an external power supply.
See the separate operating instructions for the Battery Charger.
Warning:
2-4
Battery Charger must not be located in a patient area.
Chapter 2 Introduction
AUXILIARY DC INPUT MODULE (DCM8)
The auxiliary DC Input Module, DCM8, is a small plastic enclosure with
eight non-isolated 3.5 mm input jacks for DC inputs and one 3.5 mm input jack
for an event pushbutton. Four of the DC inputs are single ended and four are
differential to allow for the greatest flexibility when connecting auxiliary
device outputs.
AUXILIARY DC INPUT MODULE
EVENT
SINGLE ENDED
DCM8
DIFFERENTIAL
Figure 2-5: DCM8 DC Input Module
The DCM8 is supplied standard with the Model AUXL-P AURA PSG System,
but is an opion with the Model AU-P AURA PSG Portable System.
For more information regarding the compatibility of a device with the AURA
PSG system, please contact Grass-Telefactor, Technical Support Services
Department. The optional Nonin PureLight® Pulse Oximeter Sensors can be
connected directly to the Amplifier Unit.
AURA® PSG Wireless/Ambulatory Recorder
2-5
SYSTEM COMPONENTS
STANDARD SYSTEM COMPONENTS
The following components are included in the Model AUXL-P AURA PSG
PC-based system:
• AURA PSG Amplifier System with
Built-in Oximeter
CompactFlash card and reader
Amplifier Battery (2) with battery charger and power supply
Pouch for AURA PSG Amplifier and 4 sizes of straps
• Base Station with
Wall-mount bracket
RPSAS40 Medical-grade Power Supply
Tether cable (CAB-21916)
• NET-CKIT Network cabling kit (Base Station to Host)
• DCM8 DC Input Module with wall-mount bracket
• 20-button programmable keypad for notation entry and system
operation
• Medical-grade Isolated Power System
The following components are included in the Model AU-P AURA PSG
Portable Laptop-based system:
• AURA PSG Amplifier System with
Built-in Oximeter
CompactFlash card and reader
Amplifier Battery (2) with battery charger and power supply
Pouch for AURA PSG Amplifier and 4 sizes of straps
• Base Station with
Wall-mount bracket
RPSAS40 Medical-grade Power Supply
Tether cable (CAB-21916)
• NET-CKIT Network cabling kit (Base Station to Host)
OPTIONAL SYSTEM COMPONENTS
Refer to CHAPTER 5: ACCESSORIES & REPLACEMENT PARTS, for a list of optional
system components.
2-6
Chapter 2 Introduction
3
Installation
Setting Up for Operation
The AURA PSG System is designed to be located in the vicinity of the test
subject, but with the ability to allow patient mobility for periods of time. The
Amplifier Unit can be placed inside a pouch worn by the patient.
The Base Station itself, and the associated power supply, can be attached to a
cart or stand for routine EEG or PSG studies.
Grass-Telefactor provides a full line of mobile carts and mounting brackets.
Please consult Grass-Telefactor Customer Support for further details.
Take care to locate these components away from dirt, dust, high-temperatures,
and liquid spill hazards. Avoid locating the unit where the power switches or
controls or cables could be bumped inadvertently.
AURA® PSG Wireless/Ambulatory Recorder
3-1
INSTALLATION
Refer to the interconnection diagram (Figure 3-6) for connection details and
cable part numbers. To install the AURA PSG system, proceed with the
following steps.
STEP 1:
STEP 2:
STEP 3:
STEP 4:
STEP 5:
STEP 6:
STEP 7:
STEP 8:
STEP 9:
INSTALLING CABLING
INSTALLING THE NETWORK INTERFACE CARD FOR ASSOCIATED COMPUTERS
SETTING UP THE RPSAS40 REGULATED POWER SUPPLY
SETTING UP THE BASE STATION
CONNECTING THE TETHER CABLE
CONNECTING AMPLIFIER UNIT INPUTS
CONNECTING OPTIONAL EQUIPMENT TO THE BASE STATION
SETTING UP THE BATTERY CHARGER
SETTING UP WIRELESS COMMUNICATION (WIRELESS MODE ONLY)
STEP 1: INSTALLING CABLING
Grass-Telefactor recommends that all cabling, network, video cabling, intercom
cabling, and any other cabling for auxiliary instrumentation be run by qualified
personnel under hospital supervision and according to local standards and
regulations.
It is good practice to use an approved isolation transformer when
interconnecting multiple pieces of equipment to the AURA PSG system to
avoid summation of leakage currents. The use of an isolation transformer
reduces the leakage current to that of the isolation transformer. If an isolation
transformer is to be used it should be EN60601-1 approved and rated for
115/240 VAC, 50/60 Hz, 600-800 VA.
STEP 2: INSTALLING THE NETWORK INTERFACE CARD
FOR ASSOCIATED COMPUTERS
The AURA PSG system may be supplied with an optional network interface
card for computers associated with the AURA PSG system. Follow the
instructions that are supplied with this card to install and test the interface card
before connecting to the AURA PSG system.
3-2
Chapter 3 Installation
STEP 3: SETTING UP THE RPSAS40 REGULATED POWER SUPPLY
Select an appropriate location that will allow for ventilation around the unit
and the outlet to be within safe reach of the Base Station. The power cable
should be run so as it will be out of the way and not be a tripping hazard.
POWER SUPPLY LINE VOLTAGE
The RPSAS40 will operate with line voltage within the range of 100 to 250
volts, covering both 115 and 230 volts operation with no user intervention.
The proper hospital-grade AC power cord is required.
STEP 4: SETTING UP THE BASE STATION
The Base Station can be located remotely from or locally to the host
computer. Depending on the setup, the network cable required will be either a
cross-over or patch 10BaseT Ethernet cable rated category 5 or higher.
If a direct connection is used, a single cross-over cable is required
(CAB-20576-03). If going through a dedicated hub or switch, a patch cable is
required (CAB-21064-025 or CAB-21064-010). A networking cable connector
(CON-20486) is also provided. Select the appropriate cable and connect the
Base Station to the host computer.
AURA® PSG Wireless/Ambulatory Recorder
3-3
STEP 5: CONNECTING THE TETHER CABLE
AU
RA
-PS
Ba
se
Sta
tion
Connect one end of the tether
cable to the Base Station by
inserting the connector
into place, as indicated
below. To disconnect
the tether cable
(26802001), pull on the
outer sleeve of the
connector to unlock
it from the unit.
Figure 3-1: Base Station tether cable connection (standard mode)
Note: Do not twist the connector or damage will result.
Connect the other end of the tether cable to the
Amplifier Unit.
DC1
AURA
RAT
PSG
Snore
Airflow
SpO2
Pulse
ECG+
CH13
Chin3
Chin1
C3
O1
ROC
A1
REF
Figure 3-2: Amplifier Unit tether cable connection (standard mode)
3-4
Chapter 3 Installation
RE
O1
RO
A1
EC
G+
CH
13
Ch
in
Ch
in
C3
Sp
Pu 2
lse
ow
rfl
Ai
Sn
or
DC
RA
Attach the inputs to the Amplifier Unit.
PS R A
STEP 6: CONNECTING AMPLIFIER UNIT INPUTS
Figure 3-3:
Amplifier Unit
connections
The following inputs are available
through the Amplifier Unit:
•
•
•
•
•
13 referential electrode inputs
2 reference electrode inputs
7 differential inputs
2 DC coupled inputs
1 connection for a Nonin
PureLight® pulse-oximeter
REF
REF
A1
GND
ROC
A2
O1
LOC
C3
O2
Chin1
C4
Chin3
Chin2
CH13
CH12
ECG+
ECG-
A list of compatible sensors is
provided in CHAPTER 5: ACCESSORIES
AND REPLACEMENT PARTS.
SpO2
Pulse
Airflow+
Airflow-
Chest+
Chest-
Snore+
Snore-
Abd+
Abd-
RAT+
RAT-
LAT+
LAT-
GND
DC1
GND
DC2
Figure 3-4: Amplifier Unit inputs
AURA® PSG Wireless/Ambulatory Recorder
3-5
STEP 7: CONNECTING OPTIONAL EQUIPMENT TO THE BASE STATION
Attach any additional equipment. Refer to Figure 3-6 for required cable numbers
and connection locations.
Figure 3-5: Base Station
Connections
To Optional
Event Button
or DCM8
Reserved
Ethernet Cable
to Computer
To RPSAS40
Power Supply
Waveforms from AUX 1 and AUX 2 DC input ports are only recorded when the
Amplifier Unit is tethered to the Base Station. Some connections are reserved
and should not be used.
STEP 8: SETTING UP THE BATTERY CHARGER
See the separate operating instructions for the Battery Charger.
STEP 9: SETTING UP WIRELESS COMMUNICATION (WIRELESS MODE ONLY)
need info on
the antenna
If the Amplifier Unit is used in wireless mode, the wireless connection between
it and the Base Station must be established. This process is not required for the
Amplifier Unit in standard mode.
1.
2.
3.
4.
5.
6.
7.
8.
3-6
Connect the tether cable between the Base Station and Amplifier Unit, as
indicated in STEP 5 CONNECTING THE TETHER CABLE.
Turn on the Base Station power.
Turn on the Amplifier Unit power.
Select Set Wireless Pairing on the Base Station menu. Then press the
ENTER key.
The Base Station will display Setting up Wireless.
The Base Station will exchange wireless device addresses with the
Amplifier Unit automatically, and then confirm the wireless connection.
The Base Station will display Wireless Confirmed.
Any time the Base Station and Amplifier Unit are both on and no tether
cable is connected, the paired units will attempt to connect with each
other. They will connect only with each other, and attempts by a third
Chapter 3 Installation
need info on
the antenna
Figure 3-6: AURA PSG connections
DC1
RAT
Snore
Airflow
CH13
SpO2
Pulse
Chin3
ECG+
O1
ROC
Chin1
A1
C3
REF
PSG
AURA
AURA® PSG Wireless/Ambulatory Recorder
AURA PSG Setup
Amplifier Unit
Wireless Mode Requires No Tether Cable
Optional Event Button
CAB-21648-10
26802001
Tether Cable
Base Station
AUXILIARY DC INPUT MODULE
EVENT
DCM8
SINGLE ENDED
Optional Event Pushbutton
CAB-21648-10
RPSAS40 Regulated
Power Supply
DCM8
DIFFERENTIAL
AC Power
Line In
To Grounded
Wall Outlet
CON-20486 Networking
Cable Connector
CAB-21617
or
3-7
CAB-21064
Ethernet Patch
Cable
CAB-20576-03
Ethernet Cross-over
Cable
or
To Ethernet Hub or Switch
To PC
Ethernet
Card
device to connect will be rejected.
SIGNAL DEFINITIONS
The Amplifier Unit includes labels for each input as a convenience to the user. The
connector marked SpO2 Pulse is intended for a Pulse Oximeter sensor. Only those
sensors listed in the Accessories section of this manual should be used.
Other connector labels match the default montage used by TWin software for
the AURA PSG. Following are signal definitions associated with these.
Referential Inputs (AC coupled) with SAFELEAD® connections
O1 & O2
Occipital electrodes as defined by the 10/20 standard
C3 & C4
Central electrodes as defined by the 10/20 standard
A1 & A2
Auricular electrodes as defined by the 10/20 standard
LOC & ROC
Left and Right Outer Canthus electrodes
Chin
There are three electrodes provided for the chin
CH12 & CH13 Optional electrodes
The Referential Inputs are designed for surface electrodes such as those
manufactured by Grass and suggested in ACNS 1994 Guideline 1 (2.1). The REF
connects to the electrode used as the reference for Referential Inputs. The two
inputs with this label are connected together inside the device so that redundant
electrodes can be used.
Differential Inputs (AC coupled)
ECG
ECG electrode pair (SAFELEAD)
Chest & Abd
Respiratory effort sensors (such as belts)
Airflow
Airflow sensor (such as thermocouples and thermistors)
Snore
Snore sensor (such as a microphone)
LAT & RAT
Left and Right Anterior Tibialis muscle electrodes
The Differential Inputs are intended for electrodes and sensors specifically
designed for use with electrode compatible inputs. Appropriate electrodes and
compatible sleep sensors are available from Grass-Telefactor as well as other
vendors. Additional guidance can be found in ACNS 1994 Guideline 15.
Auxiliary Inputs (DC coupled)
DC1 & DC2
Optional signal inputs
3-8
Warning:
All these inputs are connected to the patient side of the isolation
barrier. Never connect any of these inputs to a monitor or other
device unless it is fully isolated for patient safety.
Warning:
ECG and pulse oximetry measurements are not intended for use
in vital signs monitoring. In any critical care environments, an
independent monitor must be provided.
Chapter 3 Installation
HOST COMPUTER SETUP
Power up the Base Station and enter a valid IP address for the unit. Computers
associated with the AURA PSG system should have the recording application
software installed and configured to work with this IP address to control the
Base Station. See below for more information.
If Grass-Telefactor TWin software is used on the host computer, refer to the
TWin software manual for details on the operation of the system. A system
calibration and test recording should be preformed following the instructions
supplied in the TWin manual.
AURA PSG IP ADDRESS SETUP
This section will provide instructions on programming the IP address of the
AURA PSG system. If applicable, it is possible choose an IP address that is
consistent with the existing networking scheme of the hospital.
1.
2.
3.
4.
5.
Make sure the Base Station is powered on.
On the Base Station, push the MENU key four times to display the Set IP
Address option, and then press the ENTER key.
Use the left and right keys to toggle to the next numeric entry.
Use the up and down keys to change the numeric value.
An example IP address is: 172.016.008.200
When the IP address is finished, push the ENTER key to accept the entry.
Note: If the MENU key is pressed while changing the IP address, the
modifications will not be saved.
SUBNET MASK SETUP
This section will provide instructions on programming the Subnet Mask of the
AURA PSG system.
1.
2.
3.
4.
Make sure the Base Station is powered on.
On the Base Station, push the MENU button five times to display the
Set Subnet Mask option, and then press the ENTER button.
Use the up and down buttons to change the numeric value.
An example Subnet Mask is: 255.255.255.000
When the Subnet Mask is finished, push the ENTER button to accept
the entry.
AURA® PSG Wireless/Ambulatory Recorder
3-9
AURA VERSION
To check the version of the AURA amplifier before connection to application
software on the host computer:
1.
2.
3.
Make sure the Base Station is powered on.
On the Base Station, push the MENU button six times to display the
AURA Version option, and then press the ENTER button.
The version of firmware and software will be displayed.
NETWORK INTERFACE CARD (NIC) IP ADDRESS SETUP
This section will provide instructions on configuring computers associated with
the AURA PSG system. The IP address used for this section is different than the
one entered in the previous section. If applicable, it is possible to choose an IP
address consistent with the existing networking scheme of the hospital.
1.
2.
3.
4.
5.
3-10
From the Windows task bar, select Start > Settings > Control Panel.
Double-click on the Network and Dial up Connections icon.
In the Network and Dial up Connections window, double-click on the icon
that represents your NIC. This may be listed as Local Area Connection.
In the Status window, click on the Properties button.
Highlight Internet TCP/IP protocol by clicking on it once, then click
Properties. The Internet Protocol (TCP/IP) Properties window will appear.
Chapter 3 Installation
Figure 3-8: Internet Protocol (TCP/IP) Properties window
6.
7.
8.
9.
10.
Select Use the following IP address.
Enter an IP address that fits within the same series as the AURA PSG.
Remember, the IP address here cannot be the same as the one used in the
AURA PSG IP Address. An example IP address is: 172.16.8.199, or
172.16.8.201.
It may be necessary to change the Subnet Mask to 255.255.0.0.
Click OK when finished.
Close all windows and reboot the computer.
AURA® PSG Wireless/Ambulatory Recorder
3-11
3-12
Chapter 3 Installation
4
Operation
The AURA PSG requires a host computer with appropriate software to be attached
via a network cable to setup the system parameters. This section is an overview of
the controls, indicators, and other features available for use on the unit.
BASE STATION
The controls available on the Base Station include the DC power switch on the rear
and eight keys associated with the LCD. There are eight pushbuttons, or keys, for
interacting with the Base Station and the host computer. Some of the selections in
the menu require the host computer to be connected to the Base Station.
AURA-PSG Base Station
Figure 4-1: Base Station Front Panel Controls
AURA® PSG Wireless/Ambulatory Recorder
4-1
MENU SYSTEM
The MENU key is used to toggle through the main menu items or to back out of
a menu selection or submenu. ENTER selects the item to execute or proceed to
a submenu item. The following list describes each key on the Base Station and a
brief description of its use.
MENU key toggles through the menu items or backs out of a
menu selection back to the previous level. While in a
submenu or selection the MENU key can be used to cancel
and return back to the main menu.
Provides no function for AURA PSG.
The left/right arrows are used to navigate through a
submenu list.
The up/down arrows are used to scroll through status
information such as electrode impedance results.
The ENTER key selects the item to execute or proceeds
to a submenu.
E-TEST provides a shortcut to turn the electrode test
function on without going through the menu selection
process.
The following menu options are available:
Status
Reports communication errors with the data transfer.
Oximeter Display* Displays the current readings of the Nonin PureLight® Pulse
Oximeter on the LCD.
Set IP Address** Allows an IP address for the device to be entered. Used to
set the IP address of the Base Station. The left/right keys
activate the number in IP address to be changed and the
up/down keys increment/decrement the active number.
ENTER accepts the IP address.
4-2
Chapter 4 Operation
Check
Impedances*
Requests the host computer monitoring software to
perform an electrode test and return the results for display.
Z limit impedance selections include: 0.1, 0.5, 1, 2, 5, 10, 20,
100 kohm.
Press ENTER to select and use the left/right keys in the Z
limit selection menu. ENTER to execute the request. Use the
up/down keys to scroll through the results returned from
the application software on the host computer. MENU
returns to the main menu item list.
E-TEST key executes a request to the application software
on the host computer to perform an impedance test using
the last Z limit selected. Press ENTER to begin calibration.
Warning:
Calibrate*
The electrode impedance test should not be used with
intra-cranial electrodes.
Requests the host computer monitoring software to perform
a calibration for each channel.
* Only available when connected to application software on host computer.
** Only available when not connected to application software on host computer.
INDICATORS
A power indicator is located above the LCD and is green when the Base Station
power is on. The LCD displays the menus, electrode impedance results,
connection status, and any error messages that may occur.
Additionally, two indicator lights are used by the Ethernet connection on the
back of the Base Station. The green light indicates the Base Station is attached
to an active node, and the yellow light indicates communication activity over
the connection.
AURA® PSG Wireless/Ambulatory Recorder
4-3
AMPLIFIER UNIT
The controls on the Amplifier Unit are used to
turn the power on and off.
DC1
RAT
POWER BUTTONS
Turns the Amplifier Unit power off.
The button must be held for up to
twenty seconds to turn the power
off. This feature helps ensure the
power is not turned off accidentally.
AURA
PSG
Snore
Airflow
SpO2
Pulse
ECG+
CH13
Chin3
In error conditions, it may be necessary to
hold the Power Off button in for a
minimum of 30 seconds to turn off the
Amplifier Unit power.
Chin1
C3
O1
ROC
A1
REF
Turns the Amplifier Unit power on.
Figure 4-2: Amplifier Unit Controls
4-4
Chapter 4 Operation
INDICATORS
There are three indicator lights on the Amplifier Unit. One green indicator light
provides information about the power status of the Amplifier Unit. Two amber
indicator lights are provided. One amber light provides information about the
connection between the Amplifier Unit and Base Station. The other amber light
provides information about the Nonin pulse oximeter.
GREEN POWER INDICATOR
Amplifier Unit is powered by the tether cable
(standard mode).
Flashing Amplifier Unit is powered by battery.
Off
Amplifier Unit is not functioning.
Steady
AMBER LINK INDICATOR
The Amplifier Unit is connected to the Base Station
via the tether cable (standard mode).
Flashing Once every two seconds: The Amplifier Unit is
recording to a CompactFlash Card (standard mode).
Flashing Once per second: The Amplifier Unit is within range
of the Base Station (wireless mode).
Flashing Faster than once per second: The Amplifier Unit is
finishing writing data to the CompactFlash Card
(standard mode). This happens when the
CompactFlash has filled or if the user is attempting to
turn off the amplifier while it is writing data to the
CompactFlash. In the latter case the user can release
the power off button, the amplifier will turn off when
it is finished, usually within 30 seconds.
Steady
AMBER PULSE OXIMETER INDICATOR
Flashing The pulse oximeter is reading a pulse between
20 and 200.
AURA® PSG Wireless/Ambulatory Recorder
4-5
COMPACTFLASH CARD & BATTERY
The Amplifier Unit in standard mode, when untethered, is powered by an internal
battery and saves data on a CompactFlash memory card. CompactFlash is an
industry standard removable storage media. The battery is capable of running the
Amplifier Unit in standard mode for approximately 12 hours.
The Amplifier Unit in wireless mode is powered by the same internal battery,
but does not use a CompactFlash card. The battery is capable of running the
Amplifier Unit in wireless mode for approximately 10 hours.
To open the CompactFlash/Battery
compartment, press the tab
on the battery cover and
slide the cover outward.
Set the cover aside.
Figure 4-3: CompactFlash Card & Battery
The CompactFlash card drive is located behind the battery compartment. For
standard mode operation, slide the CompactFlash card into the drive. The top
of the card must face the bottom of the Amplifier Unit to be oriented properly
for insertion (see Figure 4-3). To remove the card, simply pull it out of the
drive. For wireless mode operation, do not insert a CompactFlash card.
Two batteries are shipped with each Amplifier Unit and will need to be
charged prior to each use. Insert a fully-charged battery into the battery
compartment. Be sure to orient the battery correctly (see Figure 4-3).
Warning:
Use only the specified battery (26759200) in the AURA PSG.
Use of unauthorized battery may cause explosion/fire hazard.
To reattach the cover, slide the cover back into position. The tab will lock the
cover in place.
4-6
Chapter 4 Operation
BATTERY CHARGER
The battery must be charged prior to each use. See the separate operating
instructions for the Battery Charger.
Warning:
Battery Charger must not be located in a patient area.
CALIBRATION
The AURA PSG system includes a built-in calibration signal generator and the
means to connect this generator to the referential amplifier inputs at the first stage
preamplifier. The generator outputs a 5 Hz, 500 µV peak-to-peak square wave. The
frequency of this source can be set by the host computer but is generally 5 Hz.
Gain calibration and correction is critical to the accurate creation of montages from
the referentially recorded data. It is recommended that a calibration procedure be
performed prior to every recording as standard practice.
Calibration controls are only available in the application software. However a
request can be sent from the Base Station via a menu item to have the application
software automatically perform a calibration. Refer to the instructions for
calibrating the amplifier hardware in the TWin software manual for more details.
Typically calibration involves starting the recorder software, putting the AURA
PSG into calibration mode, recording a segment of the calibration signal then
confirming the peak-to-peak value of the AC calibration signal. This data is then
used to automatically generate a list of correction values for both offset and gain.
ELECTRODE IMPEDANCE TEST
The AURA PSG system includes a built-in electrode test circuit that tests the
impedance of each electrode, including the reference, for referential inputs. This
function can be executed from either the application software or at the Base Station
itself. The E-TEST key on the Base Station calls this function and the results are
displayed on the LCD, based on the preferences set in the application software. If
the application software is not present this function cannot be selected.
Warning:
The electrode impedance test should not be used with
intra-cranial electrodes.
AURA® PSG Wireless/Ambulatory Recorder
4-7
RECORDING OVERVIEW
TETHERED RECORDING
During tethered recording, the Amplifier Unit is used in standard mode. It
operates while connected to the Base Station via a tether cable. Signals are
streamed to the host via this connection.
During tethered recording, use caution to avoid contact with the Amplifier
Unit “Off” button. The “Off” button must be held for 10 to 20 seconds to turn
the power off. This feature helps ensure the power is not turned off
accidentally.
Ensure the following components are available for tethered recording:
•
•
•
•
Amplifier Unit with Tether Cable — The Amplifier Unit with Tether
Cable will be used to send signals to the Base Station.
Base Station — The Base Station is used to configure the Amplifier Unit.
Host Computer with TWin Software — The computer and TWin
software is used to initiate remote recording and review recordings.
Electrodes & Sensors — These measurement components will be used
to connect the patient input signals to the Amplifier Unit.
STARTING TETHERED RECORDING
The process for starting tethered recording requires the following steps:
1.
Connect the Amplifier Unit to the Base Station via the Tether Cable.
2.
Connect the patient electrodes to the Amplifier unit.
3.
Configure the Amplifier Unit using the Base Station and associated TWin
host software.
4.
Initiate recording using the TWin Recording feature. Waveforms will
display in the TWin software waveform area.
Warning:
Protect the Amplifier Unit from exposure to liquids. If the
Amplifier Unit is exposed to liquids during recording,
discontinue use by disconnecting the electrodes from the
Amplifier unit and turning off the Amplifier Unit power.
Resumption of recording is to be performed only by qualified
personnel.
STOPPING TETHERED RECORDING
Recording is stopped using the TWin software.
4-8
Chapter 4 Operation
AMBULATORY RECORDING
During ambulatory recording, the Amplifier Unit is used in standard mode.
When untethered, the Amplifier Unit will run off a battery and save data on a
CompactFlash® memory card. The battery is capable of running the Amplifier
Unit for approximately 12 hours.
During untethered recording, use caution to avoid contact with the Amplifier
Unit Off button. The Off button must be held for 10 to 20 seconds to turn the
power off. This feature helps ensure the power is not turned off accidentally.
Ensure the following components are available for tethered recording:
•
•
•
•
•
Amplifier Unit with Tether Cable — The Amplifier Unit with Tether
Cable will be used to set up and initiate the recording.
CompactFlash Card & Battery — A CompactFlash card and fullycharged battery should be installed in the Amplifier Unit prior to
recording.
Base Station — The Base Station is used to configure the Amplifier Unit.
Host Computer with TWin Software — The computer and TWin
software is used to initiate remote recording and review recordings.
Electrodes & Sensors — These measurement components will be used
to connect the patient input signals to the Amplifier Unit.
STARTING AMBULATORY RECORDING
The process for starting ambulatory recording requires the following steps:
1.
Connect the Amplifier Unit to the Base Station via the Tether Cable.
2.
Connect the patient electrodes to the Amplifier Unit.
3.
Configure the Amplifier Unit using the Base Station and associated TWin
host software.
4.
Initiate recording using the TWin Recording feature.
5.
Turn the Amplifier Unit power off and disconnect it from the Base Station.
6.
To start ambulatory recording, turn the Amplifier Unit power on
Warning:
Protect the Amplifier Unit from exposure to liquids. If the
Amplifier Unit is exposed to liquids during recording, the
patient should discontinue use by disconnecting the electrodes
from the Amplifier Unit and turning off the Amplifier Unit
power. Resumption of recording is to be performed only by
qualified personnel.
AURA® PSG Wireless/Ambulatory Recorder
4-9
STOPPING AMBULATORY RECORDING
To stop ambulatory recording, press and hold the Off button on the
Amplifier Unit until the Amplifier Unit is turned off. This process may require
up to 30 seconds. The Amplifier Unit will turn off and recording will stop.
READING AMBULATORY DATA
The process for reading ambulatory data requires a computer with a
CompactFlash Card reader and software that can open the data files on the
card. The Base Station cannot be used to upload the data to the computer.
When the extended ambulatory recording process is complete, the resulting
data files will be stored on the CompactFlash Card in the Amplifier Unit. The
data is stored using a specific protocol.
Grass-Telefactor TWin software can be used on the host computer to read the
file and process the data. The TWin software is powerful and easy to use,
providing data acquisition, recording, and review capabilities in one flexible
package.
Remove the CompactFlash Card from the Amplifier Unit. Then insert it into the
CompactFlash Card reader on the computer. Although TWin software can read
directly from the CompactFlash Card, it is recommended that data files be
copied to a different medium such as the computer’s hard disk for further
review and analysis.
4-10
Chapter 4 Operation
WIRELESS RECORDING
The Amplifier Unit in wireless mode uses Bluetooth® technology to stream
data to a host computer via a wireless connection with the Base Station.
The Amplifier Unit must be within 25-feet (7.5 m), without obstructions, of
the Base Station.
The Amplifier Unit in wireless mode is powered by a battery and must not
have a CompactFlash Card or Tether Cable attached.
Ensure the following components are available for recording:
•
•
•
•
•
Amplifier Unit — The Amplifier Unit will be used to send signals to
the Base Station.
Battery — A fully-charged battery should be installed in the wireless
Amplifier Unit prior to recording.
Base Station — The Base Station is used to configure the Amplifier Unit.
Host Computer with TWin Software — The computer and TWin
software is used to initiate remote recording and review recordings.
Electrodes & Sensors — These measurement components will be used
to connect the patient input signals to the Amplifier Unit.
STARTING RECORDING
The process for starting recording requires the following steps:
1.
Ensure the Amplifier Unit is within 25-feet (7.5 m) of the Base Station.
2.
Connect the patient electrodes to the Amplifier Unit.
3.
Configure the Amplifier Unit using the Base Station and associated TWin
host software.
4.
Initiate recording using the TWin Recording feature. Waveforms will
display in the TWin software waveform area.
Warning:
Protect the Amplifier Unit from exposure to liquids. If the
Amplifier Unit is exposed to liquids during recording,
discontinue use by disconnecting the electrodes from the
Amplifier Unit and turning off the Amplifier Unit power.
Resumption of recording is to be performed only by qualified
personnel.
STOPPING RECORDING
Recording is stopped using the TWin software.
AURA® PSG Wireless/Ambulatory Recorder
4-11
4-12
Chapter 4 Operation
5
Accessories & Replacement Parts
Accessories & Replacement Parts
Part Number
14193512
26759200
42050100
RPS-21903
RPSAS40
IPS115
IPS230
CAB-21648-10
DCM8
KBD-21203-20
KBD-21203-58
32760200
32760404
32760403
32760402
32760401
ACS-21651
ACS-20944-01
Description
512 MByte CompactFlash Memory Card
Rechargeable 3.6 V lithium ion battery
Battery Charger
Battery Charger Power Supply
AURA PSG Regulated Power Supply
Isolated power system, 115-volt operation only
Isolated power system, 230-volt operation only
Optional Event pushbutton, 10’ (3 m) cable length, other
lengths available
DC Input Module for up to 8 DC channels
20-button Keypad for notation entry and system operation
Optional 58-button Keypad for notation entry and system
operation
AURA PSG Amplifier Pouch
AURA Pouch Strap, Adult Large
AURA Pouch Strap, Adult Small
AURA Pouch Strap, Pediatric Large
AURA Pouch Strap, Pediatric Small
Dedicated Ethernet Card for Base Station connection
for use with a PC
Dedicated Ethernet/Modem Card for Base Station
connection for lap-top use
AURA® PSG Wireless/Ambulatory Recorder
5-1
OXIMETER SENSORS
Part Number
8000J
8000JFW
8008J
8008JFW
7000A
7000P
8000AA
8000AP
8500I
Description
Adult Flex Sensor, straight, 3-foot (1 m) length cable,
includes a package of 25 8000JFW FlexiWrap® Sensor
Wraps
FlexiWrap® Sensor Wraps, package of 25
Infant Flex Sensor, straight, 40" (1 m) length cable,
includes a package of 25 8008JFW FlexiWrap® Sensor
Wraps
Infant FlexiWrap® Sensor Wraps, package of 25
Adult Finger Flexi-form Disposable Sensors, 40" (1 m)
length cable, package of 10
Pediatric Finger Flexi-form Disposable Sensors, 40" (1 m)
length cable, package of 10
Adult Articulated Finger Clip Sensor, 40" (1 m)
length cable
Pediatric Finger Clip Sensor, 40" (1 m) length cable
Patient Extension Cable, 40" (1 m) length cable
CABLES/ADAPTORS
Part Number
26802001
CAB-21916
CAB-21615-5
CAB-21616-10
CAB-21617
MCB-21678-03
MCB-20018
CAB-21911
NET-CKIT
CAB-21064-010
CAB-21064-025
CAB-20576-03
CON-20486
5-2
Description
Tether cable, 30-foot (10 m) length (Amplifier to Base Station)
Interface cable, 1/8” phone plug to PLU-880,
5-foot (1.5 m) length (CPAP to DCM8)
DCM8 to Base Station patch cable, 5-foot (1.5 m) cable
Phono to 3.5 mm 10-foot (3 m) cable. Used to connect
the CAB-21648 event button to the DCM8 (included with
CAB-21648)
Event button to Base Station adaptor, used to connect an
event button directly to the base when an optional
DCM8 DC Input Module is not available,
1-foot (0.3 m) cable length
AC Cordset IEC320, 3-foot (0.9 m) cable
Hospital-grade AC cordset, USA, 6-foot (1.8 m) cable
Adaptor: (2) 1.5 mm SAFELEAD to Key Connector
Network Cabling Kit includes:
Ethernet cable, patch. Used to connect Base Station to Host
via a hub/switch, 10-foot (3 m) cable
Ethernet cable, patch. Used to connect Base Station to Host
via a hub/switch, 50-foot (15 m) cable
Ethernet cable, cross-over. Used to directly connect Base
Station to Host, 3-foot (0.9 m) cable
Ethernet cable connector. Used to daisy chain two Ethernet
cables (RJ45 connectors) together.
Chapter 5 Accessories & Replacement Parts
CARTS & MOUNTING BRACKETS
Part Number
IT8/L
IT9
ARM-AS40
AS40WMB
AS40WMB-QR
GRS-8399
ARM-AS40-QR
Description
Mobile Cart for use with a lap-top computer
Mobile Rack Cart with drawer for full size keyboard,
for use with a desktop PC
Adjustable Arm for mounting the Base Station on a Mobile
Cart
Base Station wall-mount bracket
Optional Base Station wall-mount bracket with quick release
DCM8 wall-mount bracket
Optional Adjustable Quick Release Arm for mounting the
AURA on a Cart
TWIN PSG REVIEW WORKSTATION
Part Number
TRW-PSG
FPM-18
FPM-20
ACS-21789
Description
Latest high-performance PC*, network ready and modem,
CD-R/RW internal, Grass-Telefactor TWin PSG Review/
Analysis software, Archive Manager, TWinLOOK, Microsoft
Office, pcAnywhere software
18" flat-panel/LCD monitor
20" flat-panel/LCD monitor
Flat-panel/LCD monitor wall-mount bracket
AURA® PSG Wireless/Ambulatory Recorder
5-3
5-4
Chapter 5 Accessories & Replacement Parts
6
Maintenance
Maintenance
There is no routine maintenance required for the Grass-Telefactor AURA PSG
systems other than normal periodic checks for unusual wear, cable abrasion,
and routine cleaning.
CALIBRATION
The AURA PSG includes a built-in calibration signal source for verifying
proper operation and to simplify cross-channel gain correction and offset
adjustment. The calibration mode should be used to periodically generate a list
of correction factors for use during the display and processing of the signal
data. Refer to the appropriate recording software instructions for details.
AURA® PSG Wireless/Ambulatory Recorder
6-1
CLEANING
Perform cleaning as needed.
Electric Shock Hazard. Before cleaning the AC power supply or
any AC line powered equipment, always turn off the power and
disconnect the power cord from the AC power supply.
Warning:
Cautions
•
•
•
•
Do not autoclave or pressure sterilize the AURA PSG system.
Do not soak or immerse the AURA PSG system in any liquid.
Do not gas sterilize the AURA PSG system.
Do not use petroleum based or acetone solutions, or other harsh
solvents to clean the AURA PSG system.
To clean the AURA PSG system, use a soft cloth dampened with mild soap and
water solution. To disinfect the Amplifier unit use 70% isopropyl alcohol. Be
sure that the components are unplugged before cleaning and that the
components are completely dry before use.
ELECTRODES
Refer to the cleaning instructions supplied with the electrodes for details on
cleaning, disinfection, and/or sterilization.
STORAGE & TRANSPORTATION
For storage and transportation, it is recommended that the system and its
accessories be within the temperature range of -40 to 70° C, 500 to 1060 hPa,
and 10 to 100% RH, including condensation. When returning from temperature
extremes, allow the system to stabilize to room temperature before use.
END-OF-LIFE DISPOSAL
When disposing of the AURA PSG system components at the end of life, it is
recommended that federal, state and local laws be followed for proper disposal
of printed circuit boards, lithium-ion batteries, and plastic parts.
Never incinerate or dispose of lithium-ion battery cells into fire.
For disposal of non-Grass-Telefactor accessories, please follow the instructions
included with these items.
6-2
Chapter 6 Maintenance
7
Troubleshooting Guide
Symptom
Probable Cause
Solution
Base Station power light
not on
Base Station Power
switch off
Turn on Base Station
Base Station power
cable not plugged in
fully
Check that the DC power plug is
fully inserted and the locking ring is
hand tight
RPSAS40 AC cord not
plugged in fully
Check the RPSAS40 AC cord
Amplifier unit not
connecting to Base
Station properly
Check Amplifier unit is seated properly
No patient signals
present
Base Station
unresponsive
No pulse or oximeter
readings from the
PureLight® or incorrect
readings
AUX inputs 1 & 2 on
Base Station are not
present in recording
software
For wireless mode, ensure Amplifier
unit is within 25-feet (7.5 m) of the
Base Station
Ethernet cable not
plugged in
Check Ethernet cable connections on
both ends
IP address incorrect
Verify AURA PSG IP address at the unit
and in the recording software is correct
Oximeter not plugged
into Amplifier unit or
sensor not plugged in
Check cable connections of the
PureLight® at both the Base Station
and sensor
Sensor placement on
patient incorrect
Verify sensor is placed on patient in the
proper orientation and the disposal
adhesive secures it to the finger
Cables are not plugged
in fully
Verify cabling connections
AURA® PSG Wireless/Ambulatory Recorder
7-1
Symptom
Probable Cause
Solution
Keys on Base Station
not functional
Power not on
Turn on power to Base Station
Recording software
locked out
Check recording software status
E-TEST key onBase
Station not functional
Recording software not
running
Start recording software
Bad E-TEST results
Poor electrode
application
Check electrode application and reapply
if needed
Amplifier unit not
plugged in fully
Check Amplifier unit is tethered properly
Poor electrode
application
Check electrode application and reapply
if needed
Amplifier unit not
plugged in fully
Check Amplifier unit is tethered properly
Interference
Locate and remove sources of
interference
Poor signal quality
7-2
Chapter 7 Troubleshooting Guide
A
Appendix A
Connector Pin-outs
ETHERNET CABLE, CROSS-OVER
Used to connect Base Station directly to the Host computer.
Connector type: RJ45
Pin 1 = Pin 3
Pin 2 = Pin 6
Pin 3 = Pin 1
Pin 4 = Pin 4
Pin 5 = Pin 5
Pin 6 = Pin 2
Pin 7 = Pin 7
Pin 8 = Pin 8
ETHERNET CABLE, PATCH
Used to connect Base Station and Host computer through a dedicated
networking hub/switch.
Connector type: RJ45
Pin 1 = Pin 1
Pin 2 = Pin 2
Pin 3 = Pin 3
Pin 4 = Pin 4
Pin 5 = Pin 5
Pin 6 = Pin 6
Pin 7 = Pin 7
Pin 8 = Pin 8
AURA® PSG Wireless/Ambulatory Recorder
A-1
A-2
Chapter A Connector Pin-outs
B
Appendix B
Service Policy & Warranty
Warranty repair and service for this system must be performed by a
Grass-Telefactor service representative or at the Grass-Telefactor factory.
To contact Grass-Telefactor, refer to the SERVICE AND WARRANTY on the
following pages.
Do not use malfunctioning equipment. Make all necessary repairs or have the
equipment repaired by a Grass-Telefactor service representative. After repair,
test the complete system to verify that it complies with the published
specifications.
Warning
Do not open or remove the covers of the components. An
operator may only perform maintenance procedures specifically
described in this manual. Refer servicing to qualified service
personnel trained in the repair of this equipment.
Detailed circuit diagrams, components part lists, mechanical drawings, etc. are
available for service purposes on formal request from Grass-Telefactor.
AURA® PSG Wireless/Ambulatory Recorder
B-1
B-2
Chapter B Service Policy & Warranty

Source Exif Data:
File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.2
Linearized                      : No
Encryption                      : Standard V1.2 (40-bit)
User Access                     : Print, Modify, Copy, Annotate, Fill forms, Extract, Assemble, Print high-res
Create Date                     : 2005:11:04 13:37:49-05:00
Modify Date                     : 2005:11:04 13:38:10-05:00
Subject                         : AURA title
Page Count                      : 56
Creation Date                   : 2005:11:04 18:37:49Z
Mod Date                        : 2005:11:04 18:37:49Z
Producer                        : Acrobat Distiller 5.0.5 for Macintosh
Author                          : 
Keywords                        : 
Metadata Date                   : 2005:11:04 18:37:49Z
Creator                         : ,
Title                           : AURA title
Description                     : AURA title
Page Mode                       : UseOutlines
EXIF Metadata provided by EXIF.tools
FCC ID Filing: TQC-PSGBASE

Navigation menu