BIS™ Complete
0123
Monitoring System
Operator’s Manual
PN: PT00087175B
About this Manual
2
BIS™ Complete Monitor
Copyright Information
©2020 – 07 Medtronic. All rights reserved.
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive
Results for Life are U.S. and internationally registered trademarks
of Covidien AG.™* brands are trademarks of their respective
owners. Other brands are trademarks of a Covidien company.
Covidien is a Medtronic company.
About this Manual
BIS™ Complete Monitor
3
Table of Contents
1. Introduction 11
1.1. About this Manual 11
1.2. Introducing the BIS™ Complete Monitoring System 11
2. Safety Precautions 15
2.1. Introduction 15
2.2. Safety Symbol Definitions 15
2.3. Warnings 16
2.4. Cautions 20
2.5. Key to Symbols 23
3. Installation and Preparation for Use 31
3.1. Introduction 31
3.2. BIS™ Complete Monitor Installation and Checkout 31
3.3. Environment 33
3.3.1. Shipping and Storage Environment 33
3.3.2. Operating Environment 34
3.3.3. Power Requirements and System Grounding 35
3.3.4. Electromagnetic Compatibility Requirements 35
3.3.5. Site Preparation: Mounting the Monitor 36
3.4. The BIS™ Complete Monitoring System—Equipment and
Supplies 38
3.5. Cable Connections 50
3.6. Start Procedure / Standby Mode 51
3.7. Initial Menu Settings 54
3.4.1. BIS™ Complete Monitor 44
3.4.2. BISX™ Unit 48
3.4.3. Patient Interface Cable (PIC) 49
3.4.4. BIS Sensors 49
3.6.1. Starting the Monitor for the First Time 51
3.6.2. Starting the Monitor from Standby Mode 51
3.6.3. Power-Up Messages 52
3.7.1. Language Selection 54
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BIS™ Complete Monitor
Date and Time 55
3.7.2.
3.7.3. View/Save Settings 55
4. Operating the BIS™ Complete Monitoring System 57
4.1. Introduction 57
4.2. Preparing for Operation 57
4.3. Sensor Check 61
4.4. BIS™ Trend Data Screen 64
4.4.1. BIS™ (Bispectral Index) Value 66
4.4.2. Signal Quality Indicator 66
4.4.3. Electromyograph (EMG) Indicator 67
4.4.4. EEG Waveform Display 67
4.4.5. Message Region 67
4.4.6. BIS™ Trend Graph 68
4.4.7. Additional Screen Information 71
4.5. Main Screen Touch Keys 76
4.5.1. Alarm Touch Keys 76
4.5.2. Menu, Home, Sensor Check and Review Touch Keys
77
4.6. Menu Selections 78
4.6.1. Target Range 79
4.6.2. Secondary Variable 81
4.6.3. Chart Data 83
4.6.4. Alarm Volume 84
4.6.5. Display Modes 86
4.6.6. View/Save Settings 87
4.6.7. Help 90
4.6.8. Snapshot 90
4.6.9. Display Suppression Ratio (SR) 91
4.6.10. Monitor Mode 92
4.6.11. Export Data 95
4.6.12. BIS™ Smoothing Rate 99
4.6.13. Print (Snapshot) 100
4.6.14. Configuration Information 102
4.6.15. EEG Channels 102
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Date and Time 103
4.6.16.
4.6.17. Language 105
4.6.18. Filters 106
4.6.19. Impedance Checking 107
4.6.20. Maintenance Menu 108
4.6.21. Demo Case 108
4.6.22. Diagnostic Menu 109
4.7. Reviewing and Printing Stored Trend Data 109
4.7.1. Review Mode Touch Keys 110
4.7.2. Printing Stored Data 112
4.8. EEG Display 113
4.9. DSA Display 114
4.10. Ending a Case 116
4.11. Data Transfer 117
4.12. How the BIS™ Complete Monitoring System Works 118
4.12.1. Bispectral Index (BIS™) 120
4.12.2. Artifact Detection 120
4.12.3. System Self-Checks 120
4.12.4. Monitor Data Memory 122
4.12.5. BISX™ Data Memory 122
4.12.6. Battery Operation 123
4.12.7. The BIS™ Bilateral System 124
5. Quick Reference Guide 141
5.1. Introduction 141
5.2. Basic Operation 141
6. Preventive Maintenance, Care and Cleaning 143
6.1. Introduction 143
6.2. Care and Cleaning 143
6.3. Maintenance 145
6.2.1. Cleaning the Monitor and BISX™ 144
6.2.2. Disinfecting the Monitor and BISX™ 144
6.2.3. Cleaning the Monitor Display 145
6.3.1. Replace the PIC (Patient Interface Cable) 145
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BIS™ Complete Monitor
Checking Cable Integrity 146
6.3.2.
6.3.3. System Checkout 146
6.3.4. Checking the Battery 147
6.3.5. Checking Battery Expiry Date 149
6.3.6. Replacing the Battery 149
6.3.7. Replacing the Power Supply 150
6.3.8. Checking Leakage Current 151
6.4. Technical Documentation 153
6.5. Instrument Identification 153
6.5.1. BIS™ Complete Monitor 153
6.5.2. BISX™ 153
6.5.3. Software Revision Numbers 153
7. Diagnostics and Troubleshooting 155
7.1. Introduction 155
7.2. Maintenance Menu 155
7.2.1. Display BISX™ Connection History 156
7.2.2. Serial Protocol 156
7.2.3. Software Update 157
7.2.4. Restore Default Settings for All Modes 158
7.2.5. Audio Off Reminder 158
7.2.6. Calibrate Touch Screen 159
7.3. Diagnostics Menu 159
7.3.1. Diagnostic Codes 159
7.3.2. DSC Self Test 160
7.4. BIS™ Complete System Messages and Corrective Actions 160
7.5. Using the Reset button 174
7.6. What to do if the BIS™ Complete Monitoring System
Requires Service 175
8. Menus, Processed Variables and Glossary 177
8.1. Menu Map 177
8.2. Menu Listing 178
8.3. Processed EEG Variables 183
8.4. Glossary 186
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9. Specifications, Warranty and Software License Agreement
189
9.1. Specifications 189
9.2. Electromagnetic Compatibility Specifications 195
Guidance 196
9.3. Warranty 210
9.4. Software License Agreement 212
10. Password Protected Features 215
9.1.1. General Specifications 189
9.1.2. EEG Specifications 190
9.1.3. BISX™ Unit Specifications 192
9.1.4. Product Compliance 193
9.1.5. Essential Performance 194
9.1.6. Classification 195
9.2.1. Accessories 196
9.2.2. IEC 60601-1-2:2001 Electromagnetic Compatibility
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BIS™ Complete Monitor
List of Figures
Figure 1. Pole Clamp 37
Figure 2. The BIS™ Complete Monitoring System 43
Figure 3. Rear Panel 45
Figure 4. BISX™ Unit and PIC 48
Figure 5. Connecting the PIC 60
Figure 6. Sensor Check Graphic Screen (Values not Shown) 62
Figure 7. Sensor Check Graphic Screen with Values Shown 63
Figure 8. Screen Features – BIS™ Trend Data Screen 65
Figure 9. BIS™ Trend Data Screen with Battery Icon, Target Range,
SR, and Burst Count 70
Figure 10. BIS™ Main Screen on 2-Channel BIS™ System 74
Figure 11. BIS™ Main Screen on Bilateral (4-Channel) BIS™ System
74
Figure 12. Target Range 79
Figure 13. Secondary Variable for 2-Channel System 81
Figure 14. Secondary Variables for Bilateral (4-Channel) System 82
Figure 15. Chart Data 84
Figure 16. Alarm Volume 85
Figure 17. BIS™ Display Modes for the 2-Channel System 86
Figure 18. BIS™ Display Modes for the Bilateral (4-channel)
System 86
Figure 19. View/Save Settings 88
Figure 20. Passkey Entry Screen 89
Figure 21. Help 90
Figure 22. Snapshot 90
Figure 23. Display SR 91
Figure 24. Export Data 95
Figure 25. Smoothing Rate 99
Figure 26. Print Touch Key 100
Figure 27. Configuration Information 102
Figure 28. EEG Channels 103
Figure 29. Date and Time 104
Figure 30. Language Menu 105
Figure 31. Filters 106
Figure 32. Impendance Checkin ON/OFF 107
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Figure 33. Review Screen (Case Mode) 110
Figure 34. Review Screen (Cursor Mode) 111
Figure 35. EEG Display 114
Figure 36. DSA Display (DSA + Amplitude) on 2-Channel BIS™
System 116
Figure 37. DSA+BIS Display on 2-Channel BIS™ System 116
Figure 38. BIS™ Range Guidelines 119
Figure 39. The BIS™ Complete Bilateral Monitoring System 125
Figure 40. Sensor Check (Values not Shown) 127
Figure 41.Sensor Check with Values Shown 128
Figure 42. BIS™ Number Display/Bilateral Touch Key 129
Figure 43. Main Display (DSA) and Small Display (BIS™ Trend) 130
Figure 44. DSA Display 131
Figure 45. DSA Vertical Display on Bilateral (4-Channel) BIS™
System 132
Figure 46. DSA Horizontal Display on Bilateral (4-Channel) BIS™
System 133
Figure 47. BIS™ Trend Display 133
Figure 48. Four-channel EEG with ASYM Display 134
Figure 49. Bilateral Display Menu 136
Figure 50. Secondary Variables Menu (Bilateral) 138
Figure 51. Chart Data Screen 139
Figure 52. Demo Case 140
Figure 53. Replacing the Power Supply 150
Figure 54. Audio Off Reminder ON/OFF 158
Figure 55. Diagnostic Codes ON/OFF 159
Figure 56. BISTM Complete Menu Map for 2-Channel System 177
Figure 57. BISTM Complete Menu Map for Bilateral (4-Channel)
System 178
About this Manual
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BIS™ Complete Monitor
List of Tables
Table 1. Safety Symbol Definitions 15
Table 2. Symbol Key 23
Table 3. Shipping and Storage Environment 33
Table 4. Operating Environment 34
Table 5. Current vs. Legacy BIS Complete Monitoring System
Product Names 39
Table 6. Summary of Cables used with the BIS Complete
Monitoring System 42
Table 7. Summary of Settings Restored after System Start 52
Table 8. Alarm Touch Keys 76
Table 9. Menu, Home, Sensor Check and Review Mode Touch
Keys 77
Table 10. Monitor Mode Settings 93
Table 11. High-Priority Alarm Conditions - Messages and
Corrective Actions 160
Table 12. Low-Priority Alarm Conditions - Messages and
Corrective Actions 162
Table 13. Other System Messages and Corrective Actions 172
Table 14. Essential Performance 194
Table 15. Guidance and Manufacturer's Declaration -
Electromagnetic Emissions 197
Table 16. Guidance and Manufacturer's Declaration -
Electrommagnetic Immunity 199
Table 17. Recommended Separation Distances between Portable
and Mobile RF Communications Equipment and the BIS™
Complete Monitor 204
Table 18. Proximity Field Immunity Compliance 206
BIS™ Complete Monitor
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1. Introduction
1.1. About this Manual
This Operator’s Manual contains all of the information you need to set
up and operate the Covidien BIS™ complete monitoring system. It also
includes specific cleaning and test procedures you may occasionally be
required to perform. Although this manual is intended for trained
medical personnel, it does not assume prior knowledge or experience
with operator-programmable medical electronics devices.
Keep this Operator’s Manual with the BIS™ complete monitor for use by
the operator. This manual is also intended to be a service information
manual for service technicians or biomedical engineering personnel.
Before attempting to set up or use the BIS™ complete system, please
familiarize yourself with the safety information provided in this chapter.
Within this manual the terms BISX™ and BIS™ LoC 2 Channel are
used interchangeably. For additional information, see Table 5.
Current vs. Legacy BIS Complete Monitoring System Product
Names on page 39.
1.2. Introducing the BIS™
Complete Monitoring System
The BIS™ complete monitoring system is a user-configurable patient
monitoring system designed to monitor the hypnotic state of the brain
based on acquisition and processing of EEG signals. The BIS™ complete
Note:
Introducing the BIS™ Complete Monitoring System
12
BIS™ Complete Monitor
system processes raw EEG signals to produce a single number, called the
Bispectral Index™, or BIS, which correlates with the patient's level of
hypnosis.
The BIS Complete monitor display consists of:
• The current BIS™ number
• Raw EEG waveforms in real time
• Various signal quality indicators (EMG, SQI)
• Trend graphs of processed EEG parameters (including various
options)
• Suppression Ratio (SR, displayed upon activation by the user)
• Suppression Time (ST, a new feature, displayed upon
activation by the user, available for SW revision 3.50 and
higher)
• Alarm Indicator and Messages
• Burst Count number (when a 4-channel BIS™ system and a BIS™
bilateral sensor are in use)
The system performs self-tests to ensure that the monitor and its
components are functioning properly and that impedance levels of
patient sensors are within acceptable limits. Touch screen menus allow
the user to change the data display and review stored data.
The BIS™ system also includes a number of methods for downloading
data from the system.
Introducing the BIS™ Complete Monitoring System
BIS™ Complete Monitor
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Important Information about Using BIS™ Monitoring
The BIS™ EEG complete monitor system is intended for use under
the direct supervision of a licensed healthcare practitioner or by
personnel trained in its proper use. The system, and all its
associated parameters, is intended for use on adult and pediatric
patients within a hospital or medical facility providing patient care
to monitor the state of the brain by data acquisition of EEG signals.
The BIS™ index, one of the Complete Monitor output parameters,
may be used as an aid in monitoring the effects of certain anesthetic
agents; and its usage with certain anesthetic agents may be
associated with a reduction in primary anesthetic use and a
reduction in emergence and recovery time.
Use of the BIS™ index for monitoring to help guide anesthetic
administration may be associated with the reduction of incidence of
awareness with recall in adults during general anesthesia and
sedation.
BIS™ is a complex monitoring technology intended for use as an
adjunct to clinical judgment and training. Clinical judgment should
always be used when interpreting BIS™ in conjunction with other
available clinical signs. Rel iance on BI S™ alone for intraoperative anestheti c
management is not recommended. As with any monitored parameter,
artifacts and poor signal quality may lead to inappropriate BIS™
values. Potential artifacts may be caused by poor skin contact (high
impedance), muscle activity or rigidity, head and body motion,
sustained eye movements, improper sensor placement and unusual
or excessive electrical interference. BIS™ values should also be
interpreted cautiously with certain anesthetic combinations, such
as those relying primarily on either ketamine or nitrous
oxide/narcotics to produce unconsciousness. Due to limited clinical
experience in the following applications, BIS values should be
interpreted cautiously in patients with known neurological
disorders and those taking other psychoactive medications.
Introducing the BIS™ Complete Monitoring System
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BIS™ Complete Monitor
The BIS™ education site, www.biseducation.com, offers relevant
information and published articles on the clinical use of BIS™. In
addition, there is a “Monitoring Consciousness Using the Bispectral
Index during Anesthesia” Clinician’s Pocket Guide available on the
website and through your local Covidien Representative.
For more information, please contact Covidien at (800) 442-2051. If you
require additional information on the use of BIS, please contact Covidien
at 800-442-8655 or 617-559-7655 if calling from outside of the USA.
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2. Safety Precautions
2.1. Introduction
Carefully read this entire manual before using the monitor in a clinical
setting.
2.2. Safety Symbol Definitions
Table 1. Safety Symbol Definitions
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes
(death, injury, or adverse events) to the patient, user, or
environment.
Caution
Cautions alert users to exercise appropriate care for safe
and effective use of the product.
Note
Notes provide additional guidelines or information.
Warnings
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BIS™ Complete Monitor
2.3. Warnings
WARNING:
Explosion hazard: do not use the BIS™ complete system in a
flammable atmosphere or where concentrations of flammable
anesthetics may occur.
WARNING:
Monitor is not designed for use in MRI environment.
WARNING:
Use only the power cord supplied by the manufacturer. Never
adapt the plug from the monitor to fit a non-standard outlet.
WARNING:
U.S.A. requirement: for proper grounding, the power
receptacle must be a three-wire grounded outlet. A hospital
grade outlet is required. Never adapt the three-prong plug
from the monitor to fit a two-slot outlet. If the outlet has only
two slots, make sure that it is replaced with a three-slot
grounded outlet before attempting to operate the monitor.
WARNING:
If the integrity of the external protective earth ground is in
doubt, the BIS™ complete system shall be operated from its
internal battery power source only.
WARNING:
Be sure the monitor is mounted securely in place to avoid
personal or patient injury.
WARNING:
The BIS™ complete monitor should not be used adjacent to or
Warnings
BIS™ Complete Monitor
17
stacked with other equipment. If adjacent or stacked use is
necessary, the BIS™ complete monitor should be observed to
verify normal operation in the configuration in which it will be
used.
WARNING:
When connecting external equipment (e.g., data capture
computer), the system leakage current must be checked and
must be less than the IEC 60601-1-1 limit.
WARNING
Using accessories other than those specified may result in
increased electromagnetic emissions or decreased
electromagnetic immunity of the BIS™ complete monitoring
System.
WARNING:
The use of accessory equipment not complying with the
equivalent safety requirements of this equipment may lead to a
reduced level of safety of the resulting system. Consideration
relating to the choice shall include:
o Use of the accessory in the patient vicinity.
Evidence that the safety certification of the accessory
has been performed in accordance to the appropriate
IEC 60601-1 and/or IEC 60601-1-1 harmonized
national standard.
Due to elevated surface temperature, do not place the BISX™
unit in prolonged direct contact with patient’s skin, as it may
cause discomfort.
The conductive parts of electrodes or sensor and connectors
should not contact other conductive parts, including earth.
WARNING:
WARNING:
Warnings
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BIS™ Complete Monitor
WARNING:
To reduce the hazard of burns during use of high-frequency
surgical equipment, the sensor or electrodes should not be
located between the surgical site and the electro-surgical unit
return electrode.
WARNING:
To reduce the hazard of burns during use of brain-stimulating
devices (e.g., transcranial electrical motor evoked potential),
place stimulating electrodes as far as possible from the BIS™
sensor and make certain that sensor is placed according to
package instructions. The sensor must not be located between
defibrillator pads when a defibrillator is used on a patient
connected to the BIS™ complete system.
WARNING:
To minimize the risk of patient strangulation, the patient
interface cable (PIC) must be carefully placed and secured.
WARNING:
Shock Hazard: Do not attempt to disconnect the power cord
with wet hands. Make certain that your hands are clean and dry
before touching the power cord.
WARNING:
Universal precautions shall be observed to prevent contact
with blood or other potentially infectious materials. Place
contaminated materials in regulated waste container.
WARNING:
Do not mix disinfecting solutions (e.g., bleach and ammonia),
as hazardous gases may result.
Warnings
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WARNING:
Electrical Shock Hazard: Do not remove monitor covers during
operation or while power is connected to monitor.
WARNING:
Electrical Shock Hazard: The manufacturer's inspection of this
apparatus verified that the ground leakage current and the
patient safety current were less than the specified limits
established by the applicable safety standards. As a matter of
safe practice, the institution should conduct periodic tests to
verify these currents.
WARNING:
Whenever an event such as spillage of blood or solutions
occurs, re-test ground leakage current before further use.
WARNING:
Leakage current must be checked by a qualified biomedical
engineering technician whenever instrument case is opened.
WARNING:
Power supply is internally fused. Replace power supply only
with Covidien BIS Complete power supply.
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the BIS™
complete monitoring system, including cables specified by the
manufacturer. Otherwise, degradation of the performance of
this equipment could result.
Check Target Range alarm limits to ensure they are appropriate
WARNING:
WARNING:
Cautions
20
BIS™ Complete Monitor
for the patient being monitored with each use. Ensure Target
Range alarm limits do not exceed the standard thresholds set
by the institution.
WARNING:
Do not decrease the adjustable alarm volume below ambient
sound levels. Decreasing the alarm volume below ambient
levels may compromise patient safety.
2.4. Cautions
Caution:
Read this entire manual carefully before using the monitor in a
clinical setting. Do not autoclave the BISX™ unit or monitor.
Autoclaving will seriously damage both components.
Caution:
Do not set the Target Range alarm limits to extreme values that
render the monitoring system useless. Ensure Target Range alarm
limits are appropriate for each patient.
Caution:
Do not block ventilation inlet holes on the underside of monitor.
Caution:
Do not open BISX™ unit for any reason. The seal to prevent liquids
from entering the BISX™ unit may be damaged if opened.
Caution:
Service or repairs must be performed only by qualified biomedical
technicians.
Cautions
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Caution:
The BIS™ complete system has been designed to operate with a
BIS sensor. The sensor is a silver/silver chloride electrode array
that utilizes Covidien's patented Zipprep™ technology and uses a
proprietary connector. Use of other electrodes is not
recommended.
Caution:
To completely remove power from the unit: put the monitor in
Standby mode, disconnect power cord from the power receptacle
of the monitor, then remove the battery from the monitor.
Caution:
Continuous impedance checking may need to be disabled if the 1
nanoampere 128 Hz impedance check signal interferes with other
equipment (e.g., evoked potential monitors).
Caution:
Considerations when using Electro-Convulsive Therapy (ECT)
equipment during BIS™ monitoring: Place ECT electrodes as far as
possible from the BIS sensor to minimize the effect of
interference. Certain ECT equipment may interfere with the
proper function of the BIS™ monitoring system. Check for
compatibility of equipment during patient setup.
Caution:
Check the battery annually by operating a BIS™ complete monitor
that has been disconnected from the wall socket and that has
been charged to full capacity (at least 6 hours of charge time).
After long periods of storage, charge the battery for 6 hours to
assure full capacity. If the BIS™ complete monitor fails to operate
reliably from the battery for approximately 3 hours (or 2 hours
with BISX™ or BISX4™ unit attached), battery replacement is
required.
Cautions
22
BIS™ Complete Monitor
Caution:
Check the battery pack annually to ensure that the expiration date
listed on the battery pack is not exceeded. If the expiration date is
exceeded, then dispose of the battery.
Reference 6.3.5 Checking Battery Expiry Date on page 149, for
instructions on how to access battery and expiration date.
Caution:
The BIS™ complete monitor contains an internal Lithium ion
battery. The battery must be removed by a qualified service
technician and disposed of or recycled in accordance with the
national laws of the country. Contact Covidien or the local
distributor for a replacement battery: Covidien part number 186-
0208.
Caution:
Avoid liquid ingress to the Patient Interface Cable. Contact of
fluids with the PIC sensor connector can interfere with PIC
performance. Service or repairs must be performed only by
qualified biomedical technicians.
Caution:
The BIS™ complete system complies with the electromagnetic
compatibility requirements of IEC 60601-1-2. Operation of this
device may affect or be affected by other equipment in the
vicinity due to electromagnetic interference (EMI). If this occurs:
o Increase separation between devices.
Re-orient device cabling.
Plug devices into separate outlet circuit branches.
Reference 9.2 Electromagnetic Compatibility Specifications
on page 195.
Caution:
Do not disconnect the BISX™ unit during the software update.
Key to Symbols
BIS™ Complete Monitor
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Caution:
When connecting or disconnecting BISX™ unit, take care not to
touch the exposed contacts of either connector. Damage due to
electrostatic discharge may result.
Important: The BIS™ complete system complies with the European
Medical Device Directive (MDD) and applicable regulatory requirements
of the country distributed to and carry the CEXXXX Marking.
Declarations of Conformity provided upon request where appropriate.
2.5. Key to Symbols
A key to the symbols that may appear on the BIS™ Complete system
appears below.
Table 2. Symbol Key
Symbol
Description
Latex Free product
Do Not Reuse
Key to Symbols
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BIS™ Complete Monitor
Symbol
Description
Caution: Consult Accompanying
Documents
Follow Instructions for Use
Consult Instructions for Use
Storage Temperature Limits
Packaging Labeling: Fragile
Packaging Labeling: Do Not Get Wet
Key to Symbols
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Symbol
Description
Packaging Labeling: This Side Up
Recyclable
Product marked with the “e” does not
contain any toxic or hazardous substances
or elements, and is green and
environmental. The product can be
recycled.
Product marked with a number contains
certain toxic or hazardous substances or
elements, and can be used safely during its
Environment-Friendly Use Period (EFUP).
The product should be recycled. The
Environment-Friendly Use Period is valid
only when the product is operated under
the conditions defined in the product
manual.
1
In regards to European Union Directive 2006/66/EC on batteries and accumulators and waste
batteries and accumulators: The Batteries Directive, 2006/66/EC, introduced new
Crossed out wheelie bin indicates separate
treatment from general waste at end of life
1
Key to Symbols
26
BIS™ Complete Monitor
Symbol
Description
Type BF Equipment
Type BF Equipment Defibrillator-proof
Alternating Current
Direct Current (D/C)
Caution: Hot Surface
Classified by Underwriters Laboratories
Inc.® with respect to electric shock, fire and
mechanical hazards only, in accordance
with UL 60601-1 and IEC60601-2-26
requirements, effective September 26, 2008, regarding removability of batteries from
waste equipment in EU Member States. To comply with this Directive, this device has
been designed for safe removal of the batteries at end-of-life by a qualified service
technician. Infected units should be de-contaminated before they are sent for recycling,
in accordance with Ca
Directive 2002/96/EC on waste electrical and electronic equipment (WEEE). All waste
electrical and electronic equipment (WEEE) should be disposed of and collected
separately. This product is Electrical and Electronic Equipment and should be disposed of
in accordance with national and local legislation and requirements.
re and Clea ning (6.2) o
f this manual. In regards to European Union
Key to Symbols
BIS™ Complete Monitor
27
Symbol
Description
Conformité Européenne (CE) Marking of
Conformity to European Medical Device
Directive. CEXXXX represents the Notified
Body number
Recognized under the Component
Recognition Program of Underwriters
Laboratories Inc.
Authorized Representative in the European
Community
Catalog Number
Not connected to protective earth
Manufacturer
Manufacturer Date
Use by YYYY-MM-DD or YYYY-MM
Batch Code
Key to Symbols
28
BIS™ Complete Monitor
Symbol
USB-A
USB-B
Description
Serial Number
Data I/O, RS-232 Serial Port
Universal Serial Bus: Type A
Universal Serial Bus: Type B
Battery Location
Reset Button
Monitor Power ON
Monitor Power OFF or Standby Mode
PVC-free product
Operating on Battery
No Battery is Installed in Monitor
Key to Symbols
BIS™ Complete Monitor
29
Symbol
Description
USB Drive: Data Export is in Progress
A Printable File Is Being Transferred to the
USB Drive
Green Bell Icon – Alarms Active
Yellow Bell with Countdown Timer – Alarms
Paused
Red Bell with ‘X’ – Alarms Silenced
NOTE: When alarms are silenced, an audible
reminder sounds at 3-minute intervals. This
reminder can be disabled via the
Maintenance Menu (passkey protected).
A green box denotes ON or active
condition.
A red box with an ‘X’ denotes OFF or cancel.
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