QRS BIOLOG 3000i User manual

BIOLOG 3000i™
User Manual
6 AND 12-LEAD SIMULTANEOUS ECG RECORDER
QRS DIAGNOSTIC, LLC
14755 27th Ave North http://www.QRSdiagnostic.com
Plymouth,MN 55447 Tel [phone]
USA Fax [phone]

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WARRANTY
All instruments sold and supplied by QRS Diagnostic, LLC are
guaranteed to be free from defects in material and workmanship for a
periodof3yearsfromdateofpurchase.Allsuppliesandaccessories
carry a 90-day limited warranty. This includes ECG lead wires.
If in the judgement of QRS Diagnostic the instrument is proven to be
defective during the warranty period it will be repaired or replaced with
no charge for parts or labor. An extended hardware warranty is
availableatadditionalcost.
This warranty does not cover any instrument that has been damaged
by accident, misuse, abuse or has been altered or repaired by anyone
other than an authorized QRS Diagnostic agent. This warranty also
does not cover any unit that has had a serial number removed, defaced
or rendered illegible.
This warranty is in lieu of all other warranties expressed or implied.
Including warranties of merchantability and fitness, and is hereby
limited to repair or replacement of instruments found defective during
the warranty period.
ALL REPAIRS MUST BE MADE BY AN AUTHORIZED QRS
DIAGNOSTIC AGENT. THE INSTRUMENT MUST BE RETURNED
FOR REPAIRS AT THE EXPENSE OF THE PURCHASER. IN-
WARRANTY REPAIRED UNITS WILL BE RETURNED AT THE
EXPENSE OF QRS DIAGNOSTIC OR ITS AUTHORIZED AGENT.
INSTRUMENTS SENT BY MAIL OR COMMON CARRIER SHOULD
BE INSURED AGAINST LOSS OR DAMAGES, AS THEY ARE NOT
COVERED BY THIS WARRANTY.
6000-4182Rev D

SERVICE
For service, please contact the QRS Diagnostic, LLC Service
Department at [phone]. Service Representatives are
available by phone Monday through Friday, from 8 a.m. to 5 p.m. Central
Standard Time. You can also contact Technical Support by email at
[email protected]. In the event that your problem can not
be fixed over the phone or via email you will be issued a Returned
Merchandize Authorized number (RMA#). Please have the serial
number of your unit available. Please re-package your unit in the original
packingmaterialsifpossibleandshipitto:
QRS Diagnostic
14755 27th Ave N
Plymouth, MN 55447
This document contains proprietary information, which is protected by
copyright. All rights are reserved. No part of this document may be
photocopied, reproduced, or translated to another language without
the written consent of QRS Diagnostic, LLC. The information
contained in this document is subject to change without notice.

FOREWORD
Thank you for choosing the BIOLOG 3000iportable ECG monitor.
BIOLOG 3000iis the world’s most portable multi-functional ECG
recorder. It which can be used on its own for instant cardiac monitoring
or with other System 3000icomponents to provide an integrated
diagnostic monitoring system.
The BIOLOG 3000iconsists of a unit weighing 270 grams and a
simultaneous patient cable. This allows you to obtain, store and
analyzepatient ECG data quickly and with great confidence.
Cardiac records are stored by the BIOLOG 3000i, which then can be
transferred to QRS Diagnostic’s patient management software,
CardioView.Alternatively they can be printed to an inkjet printer via the
Biolog Printer Interface.
The BIOLOG 3000i’s capability to perform electrocardiograms by direct
chest placement makesit especially suited for Emergency Care,
allowing when necessary the use of real time telephonic monitoring.
We are sure that this device will enhance your medical practice and
allow you to achieve a greater level of freedom without losing the
power of diagnosis you have been accustomed to.

PRECAUTIONS
WARNING: To prevent the possibility of electrocution, ensure that the rear electrodes are
not in contact with the patient while device is connected to any peripheral device.
WARNING: The following precautions need to be taken when a defibrillator is used on a
patient:
•Do not touch the patient during defibrillation.
•Do not touch the defibrillator’s paddle-electrode surface when discharging the
defibrillator.
•Keep defibrillator electrodes well clear of other electrodes or metal parts in contact
with the patient.
•If a person is touching the patient, bed, or any conductive material in contact with the
patient during defibrillation, the delivered energy may be partially discharged through
that person. Make sure persons stand away from the patient, bed, and other
conductive material before discharging the defibrillator.
2
WARNING: Batteries and other disposables used in conjunction with this device must be
disposed of in accordance with the national requirements in the country of use.
CAUTION: A 6L Biolog Patient cable or 12L Biolog patient cable is required to be used in
conjunction with the BIOLOG 3000iin order to provide protection against the effect of the
discharge of a cardiac defibrillator and against high frequency burns.
Conductive parts of electrodes and associated connectors, including the neutral electrode,
should not contact other conductive parts including earth.
The BIOLOG 3000iis not intended to be sterilized or used in a sterile environment and
therefore is not suitable for direct cardiac application.
The BIOLOG 3000iis not suitable for use with flammable anaesthetics and offers no
water ingress protection.
Inspect the BIOLOG 3000ielectrocardiograph and 6L Biolog Patient Cable or 12L Biolog
patient cable regularly for signs of mechanical damage, particularly around patient leads.
To verify correct operation of the electrocardiograph, connect all patient leads to a patient
and check that there is a valid ECG signal on every lead by viewing the signal on the
BIOLOG 3000iscreen.
CAUTION: Federal law in U.S.A. restricts this device to the sale by or on the order of a
physician.
CAUTION: An authorized QRS Diagnostic, LLC service agent must service this device.

Symbols used on the BIOLOG 3000iand patient cables
Attention: Consult accompanying
documents. Patient cable connection
socket.
Type BF equipment. OPower off.
Type BF defibrillator proof applied
part. IPower on.
Class II equipment.
Internally powered device.
Regulatory compliance:
•IEC60601-1 amendments 1 & 2
•C22.2 No 601.1-M90 & UL 2601-1 (when used as part of the BLY-501 adapter
system)

Attention should be paid to the following EMC information prior to installing
or using QRS Diagnostic medical devices:
·Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of QRS Diagnostic
medical devices.
·QRS Diagnostic medical devices have been tested and found to comply with IEC/EN 60601-1-2.
·Computers, cables and accessories not tested to 60601-1-2 may result in increased emissions or decreased immunity of QRS
devices.
·Verify normal operation if utilizing QRS Diagnostic medical devices adjacent to or stacked with other electrical equipment.
ESD Information specific to the QRS Biolog:
ESD Symbol:
Electrostatic Sensitive Device
Warnings:
·When utilizing the Biolog for 6 or 12-channel ECG acquisition, do not touch or make connection with or to the
sensors on the back of the Biolog unless Electrostatic Discharge (ESD) precautions are taken.
Cautions:
· Place the Biolog on an insulated surface during 6 or 12-channel ECG acquisition to prevent operator contact
with the sensors during ECG acquisition.
·QRS Diagnostic recommends all personnel involved with Biolog operations review and understand the ESD
Symbol, Warning, and Caution information.
o
Guidance and manufacturer's declaration - electromagnetic emissions and immunity
QRS Diagnostic medical devices are intended for use in the electromagnetic environment(s) specified below. Users of this
equipment should assure that it is used in such environment(s).
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 QRS Diagnostic equipment uses RF energy only for its
internal function. Therefore, its RF emissions are not likely
to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B QRS Diagnostic medical devices are suitable for use in all
establishments including domestic establishments and those
directly connected to the public low-voltage power supplies
buildings used for domestic purposes.
Not applicable for QRS Devices other
than Universal ECG.
Class A for Universal ECG Cable
Voltage Fluctuations/flicker
emissions
IEC 61000-3-3
Harmonic emissions
IEC 61000-3-2
Not applicable

12
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%
Electrostatic Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 air
Electromagnetic Environment Guidance
IEC 60601 Test Level
Immunity Test
Electrical fast transient burst
IEC 61000-4-4
(Note: Not applicable for Biolog & Sensaire)
Surge
IEC 61000-4-5
(Note: Not applicable for Biolog & Sensaire)
Voltage dips, short interruptions and voltage
variations on power supply input lines
IEC 61000-4-11
(Note: Not applicable for Biolog & Sensaire)
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8
Note UT is the a.c. mains voltage prior to application of the test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
3 A/m
3 Vrms
150 KHz to 80 Mz
3 V/m
80 MHz to 2.5 GHz
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
±6 kV contact
±8 air
Compliance Level
3 A/m
3 Vrms
3 V/m
Mains power quality should be that of a typical commercial or hospital environment
Mains power quality should be that of a typical commercial or hospital environment.
If the user of QRS medical devices requires continued operation during power
mains interruptions, it is recommended that the computer to be used is powered
by an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical loca-
tion in a typical commercial or hospital environment.
Portable and mobile RF Communications equipment should be used no closer to
any part of QRS Diagnostic medical devices, including cables, than the
recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey, a should be less than the compliance level in each frequency range. b
Interface may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which QRS medical devices
are used exceeds the applicable RF compliance level above, QRS medical devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating QRS medical devices.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment
and QRS Diagnostic medical devices.
QRS Diagnostic medical devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of QRS Diagnostic medical
devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and QRS Diagnostic medical
devices as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter
W
Separation distance according to frequency of transmitter
150 kHz to 80 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.23
0.38 0.73
2.3
1.2
1.2
7.3
23
3.8
3.8
12
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance din metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Mains power quality should be that of a typical commercial or hospital environment
0.12
80 MHz to 800 MHz
0.38
QRS Diagnostic medical devices are intended for use in the electromagnetic environment(s) specified below. Users of this equipment should assure that
it is used in such environment(s).
Guidance and manufacturer's declaration - electromagnetic emissions and immunity

TABLE OF CONTENTS
INTRODUCTION...................................................................................7
1.1 WHAT IS THE BIOLOG 3000I?........................................................7
1.2 SYSTEM 3000ICOMPONENTS ..........................................................8
1.3 FEATURE LOCATIONS ......................................................................9
SETTING UP THE BIOLOG 3000I...................................................... 10
2.1 SET UP INSTRUCTIONS..................................................................10
2.1.1 Installing the Batteries .......................................................... 10
2.1.2 Start Up ............................................................................... 11
2.2 CHECKING THE BATTERY STATUS ...................................................12
2.3 THE SET UP MENU .......................................................................13
2.3.1 To Access the Set Up Menu ................................................. 13
2.3.2 Navigating through the Set Up Menu.................................... 14
2.4 SET UP SCREEN 1........................................................................16
2.4.1 LCD Backlight Illumination.................................................... 16
2.4.2 Mute the QRS Beeping ........................................................ 16
2.4.3 Transtelephonic Mode .......................................................... 16
2.4.4 Automatic Device Identification (ADI).................................... 17
2.4.5 Setting the Time................................................................... 17
2.5 SET UP SCREEN 2........................................................................18
2.5.1 Date Format......................................................................... 18
2.5.2 Setting the Date ................................................................... 18
2.5.3 Enabling Simultaneous Acquisition ....................................... 18
2.5.4 Total Single Lead Recording Time ........................................ 19
2.5.5 Selecting the Mains (50/60 Hz) Filter .................................... 20
2.5.6 Print Speed .......................................................................... 20
2.6 SET UP SCREEN 3........................................................................21
2.6.1 Transmission Settings .......................................................... 21
2.6.2 Modem selection.................................................................. 21
2.6.3 Power down......................................................................... 21
2.7 SET UP SCREEN 4........................................................................22
2.7.1 Menu Display ....................................................................... 22
2.7.2 Saving the Set Up Parameters ............................................. 22

RECORDING THE ECG...................................................................... 23
3.1 GENERAL PREPARATIONS ..............................................................23
3.2 THORAX PLACEMENT OPTION ........................................................24
3.2.1 Acquiring an ECG in Thorax Placement Mode...................... 25
3.2.2 Saving a Single Lead ECG to Memory ................................. 26
3.2.3 Reviewing an ECG Stored in Memory .................................. 26
3.4 SIX OR TWELVE LEAD CABLE OPTION..............................................27
3.4.1 Recording an ECG with a 6 or 12 Lead Patient Cable .......... 27
3.4.2 Acquiring and Saving a 6 or 12 Lead ECG ........................... 30
PRINTING & TRANSMITTING THE ECG ........................................... 31
4.1 TELEPHONE TRANSMISSION...........................................................31
4.2 DIGITAL TRANSTELEPHONIC MODE .................................................32
4.3 USE WITH CARDIOVIEW ................................................................35
4.4 PRINTING WITH THE Biolog Printer Interface...................................35
MAINTENANCE.................................................................................. 36
1. Batteries ................................................................................... 36
2. Electrodes................................................................................. 36
3. Cleaning and Disinfection.......................................................... 37
TROUBLESHOOTING........................................................................ 38
APPENDIX A: SPECIFICATIONS ....................................................... 41
APPENDIX B: NOTICES..................................................................... 42

7INTRODUCTION
CHAPTER 1
INTRODUCTION
1.1 What is the BIOLOG 3000i?
BIOLOG 3000iis a hand-held battery operated device designed to:
•Acquire and store in memory 5 to 200 secs. of a single lead ECG
via thorax placement.
•Acquire 5 to 80 seconds of simultaneous 6 or 12 Lead ECG, via
the 6 or 12 Lead patient cable.
The BIOLOG 3000iincorporates the following features:
•Single lead ECG acquisition.
•Diagnostic quality 6 and 12 Lead Simultaneous ECG acquisition.
•High definition LCD screen, readable in bright light and with
switchable backlighting for low light conditions.
•Heart rate monitoring (20 to 250 beats per Min.) and display.
•Automatic Device Identification facility for management of
recordings.
•Battery status bar on screen.
•Infra-red linked companion printer interface with 25 and 50
mm/second print speeds.
•Transtelephonic transfer of recordings.

INTRODUCTION 8
1.2 System 3000iComponents

9INTRODUCTION
1.3 Feature Locations
Figure 1.1 BIOLOG 3000iTop View
Figure 1.2 BIOLOG 3000iBottom View
DISPLAY
INFRA-
RED
WINDOW
CONTRAST
CONTROL
REVIEW SWITCH
HOLD SWITCH
MODE SWITCH
ON/OFF SWITCH
PATIENT CABLE
SOCKET
AUDIBLE
TELEPHONE
OUTPUT
IDENTIFICATION
LABEL
ELECTRODE
BATTERY
COMPARTMENT
COVER

SETTING UP THE BIOLOG 3000i10
CHAPTER 2
Setting up the BIOLOG 3000i
2.1 Set Up Instructions
2.1.1 Installing the Batteries
Your BIOLOG 3000iis supplied with two AA (LR6) 1·5V alkaline
batteries.
•Slide the ON/OFF switch to OFF position.
•Remove the battery compartment cover, by pressing down on the
cover, while simultaneously sliding it backwards (Figure 2.1).
Figure 2.1 Opening the Battery Hatch
•Load the Batteries with Correct Polarity.
•Match the battery polarity signs with the polarity marked on the
interior of the battery compartment casing.
Figure 2.2 Inserting the batteries
•Close the battery compartment
NOTE: Check the batteries were inserted with correct polarity (Figure 2.2).

11 SETTING UP THE BIOLOG 3000i
Align, press and slide the battery compartment cover until the locking
catch snaps into position (Figure 2.3).
Figure 2.3 Closing the battery hatch
2.1.2 Start Up
Slide the BIOLOG 3000iON/OFF key to the ON position (Figure 2.4).
The screen will display:
•The title screen for 2 seconds;
•The Set Up Menu for 2 seconds (if configured to); and
•The ECG display screen. If the electrodes are not applied, the
center of the screen will show the “Leads Off” symbol:
(- - - - -)(- - - - -)
Figure 2.4: Turning the BIOLOG 3000ion
At any time, you can adjust the contrast of the LCD display with the
CONTRAST control button situated on the side of the unit (this may be
necessary to produce a visible display if it has been misadjusted).

SETTING UP THE BIOLOG 3000i12
2.2 Checking the Battery Status
The power remaining in the batteries is displayed on screen by the
battery status bar.
The battery status bar is located.
•At the bottom of the Set Up Menu screen (Figure 2.5).
Or
•At the top of the screen during normal operation (Figure 2.5).
The battery status bar is an indicator of the battery voltage, with 8
segments showing the voltage range for usable operation.You can
visually check at any time how much power remains in the batteries.
When the voltage approaches the minimum for reliable operation, the
symbol BAT appears at the bottom of the screen. At this stage, you
should complete your procedure and replace the batteries, as some
operations such as printing and transferring data to a PC cause a dip in
the power levels, which can cause the Biolog to shut down without
warning.
Battery longevity is affected by backlighting. To preserve battery life, you
should turn off the backlight. If you turn the backlight ON or OFF, you
will notice that the battery status bar adjusts itself to the new condition.
Figure 2.5: Checking Battery Status

13 SETTING UP THE BIOLOG 3000i
2.3 The Set Up Menu
The Set Up Menu displays the following functions and their current
settings:
Screen 1
•The Backlight
•Mute the QRS beeping
•The Transtelephonic Mode
•Automatic Device Identification header for transtelephonic
transmission
•Time
Screen 2
•Date format
•Date
•Simultaneous Acquisition Enabled
•Length of recording
•The 50/60 Hz AC Filter
•The Print Speed of the printer
Screen 3
•Infra-red transmission settings
•Modem settings
•Power down time
Screen 4
•Menu Display
2.3.1 To Access the Set Up Menu
There are two ways to access the setup menu:
•If the setup menu appears briefly after power up, press any key
while it is displayed. The setup menu only appears at power up
if the Biolog has been configured this way.
or
•Press and hold the MODE key, then press the HOLD key at the
same time. The HOLD key must be pressed shortly after holding
the MODE key, if left too long there will be a timeout and the
screen will briefly go blank. If this happens, release both keys and
try again. When the setup screen appears, both keys can be
released.

SETTING UP THE BIOLOG 3000i14
2.3.2 Navigating through the Set Up Menu
•The Hold KEY selects…
The Hold key selects and highlights the items you wish to change
within the Set Up Menu.
Each time you press the Hold key within the Set Up Menu, the
cursor moves to the next field or screen. There is no button to go
backwards, if necessary you can repeat the cycle through all of
the fields and screens, until again reaching the required field.
•The Review (REV) Key changes…
The Review key changes the value of the highlighted selected
item.If there is more than one option, you can cycle through all of
them until reaching the required selection.
•The Mode Key saves…
Press the Mode key to save the new values.
Cancelling changes: The Set Up Menu will revert to previous settings
when Mode key is not pressed after changing the Set Up Menu. To
confirm cancellation of changed items, turn the power off and on, then
review the Set Up Menu.
•The rightmost column of the setup screen displays symbols to
remind you to:
( ^) Press the 'Up' arrow key (REV) to increase values
( `) Press 'Right' arrow key (HOLD) to select values
( OK ) Press 'OK’ symbol key (MODE) to save the settings

15 SETTING UP THE BIOLOG 3000i
Figure 2.6: Moving the cursor to the desired position
•To increase the number, press the REV key (up arrow) until the
desired number is shown. Hold the key down for fast scrolling.
Release the key when the desired value is displayed (Figure 2.7).
Figure 2.7: Selecting a desired value

SETTING UP THE BIOLOG 3000i16
2.4 Set Up Screen 1
Figure 2.8: Screen 1
2.4.1 LCD Backlight Illumination
The LCD Backlight can be turned ON or OFF as desired.
•First move the cursor to the small circle ($)on the Set Up Menu
using the HOLD key.
•To turn the backlight ON/OFF press the REV key. When the
backlight is turned on, the small circle symbol changes to a sun
symbol (%).
The Battery Status Bar adjusts itself automatically (Refer to Section 2.2).
2.4.2 Mute the QRS Beeping
Some patients may be disturbed by the beeping sound made on the
detection of every QRS.
•To mute this sound, press the HOLD key to select the open symbol
(•)
•To change the setting press the REV key. The symbol will change to
(~), indicating that QRS Beeping is muted.
2.4.3 Transtelephonic Mode
BIOLOG 3000iis able to transmit a stored ECG recording, using
acoustic coupling via atelephone to a remote site equipped with a
suitable reception system. This is provided for backward compatibility
with old systems, and is no longer supported. Transmission by digital
modem is now recommended (see modem selection).