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English
2nd edition
2106778-002 paper
31 May 2018
Table of contents
Table of contents
2 Safety information 5
2.1 General safety statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Safety message signal words. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3 Safety symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 System introduction 9
3.1 Short description of the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2 System components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2.2 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2.3 Input devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2.4 Acquisition modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.2.5 CARESCAPE Network MC or S/5 Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.2.6 CARESCAPE Network IX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.2.7 Unity Network ID connectivity device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.8 Secondary display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.9 Printers and recorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2.10 Service Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3 Controls and connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.3.1 Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.3.2 Side views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3.3 Rear views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.4 IEC 60601-1 classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.5 Service information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.5.1 Service requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.5.2 Equipment identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.6 Product security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.6.1 Security features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.6.2 Security operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.6.3 Product change management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.6.4 Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
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5 Pre-installation requirements 51
5.1 Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.2 Compatibility check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.3 Network infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.3.1 MC Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.3.2 Wireless MC Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.3.3 S/5 Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.3.4 S/5 Wireless Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.3.5 IX Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.4 Installing the mounting hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.5 Unity Network ID connectivity device installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.6 Power and environmental requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6 Hardware installation 57
6.1 Installing a battery into the patient monitor and the PDM module . . . . . . . . . . . . . . . . . . . . . . 57
6.1.1 Testing the battery charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
6.1.2 Installing the battery into the patient monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.1.3 Installing the battery into the PDM module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.2 Mounting the patient monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.3 Connecting a secondary display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.3.1 Connections to D15K and D19KT displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.4 Installing parameter modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.4.1 Installing a PSM or a PDM module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.5 Connecting to the mains power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
6.6 Connecting to the MC Network or the S/5 Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
6.7 Connecting to the IX Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
6.8 Connecting to a Unity Network ID connectivity device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
6.9 Connecting USB devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
6.10 Connecting iCollect and other data acquisition systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6.11 Connecting a remote-on cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6.12 Connecting a local printer to the IX connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
7 Configuration 69
7.1 Adjusting display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
7.1.1 Adjusting the brightness of the integrated primary display . . . . . . . . . . . . . . . . . . . . . . 69
7.1.2 Calibrating a touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
7.1.3 Adjusting optional secondary display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
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11 Troubleshooting 145
11.1 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
11.2 Webmin - Information tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
11.2.1 Configuration information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
11.2.2 Device information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
11.3 Webmin - Diagnostics tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
11.3.1 Hardware statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
11.3.2 Ping a TCP/IP network device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
11.3.3 WLAN diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
11.3.4 Log files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
11.4 Power management LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
11.5 Network status LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
11.6 Battery diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
11.7 Error messages and codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
11.8 Problems and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
11.8.1 Start-up failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
11.8.2 User interface issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
11.8.3 Incorrect system time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
11.8.4 License issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
11.8.5 Recorder issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
11.8.6 Acquisition module problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
11.8.7 CARESCAPE Network communication issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
11.8.8 S/5 Network communication issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
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About this manual
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About this manual
1.7 Trademarks
Listed below are GE Medical Systems Information Technologies, Inc. and GE Healthcare Finland
Oy trademarks. All other product and company names contained herein are the property of
their respective owners.
GE, GE Monogram, and CARESCAPE are trademarks of General Electric Company.
MUSE, Trim Knob, and UNITY NETWORK are trademarks of GE Medical Systems, Information
Technologies, Inc.
Entropy is a trademark of GE Healthcare Finland Oy.
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Safety information
2 Safety information
2.1 General safety statements
See the user’s manual for a list of general safety statements.
This device is intended for use under the direct supervision of a licensed health care
practitioner.
Contact GE for information before connecting any devices to the equipment that are not
recommended in this manual.
Parts and accessories used must meet the requirements of the applicable IEC 60601 series
safety standards, and/or the system configuration must meet the requirements of the IEC
60601-1 medical electrical systems standard. Refer to the patient monitor’s supplemental
information manual for compatible parts and accessories.
Periodically, and whenever the integrity of the product is in doubt, test all functions.
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:
• use of the accessory in the patient vicinity; and
• evidence that the safety certification of the accessory has been performed in accordance
to the appropriate IEC 60601-1 harmonized national standard.
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Safety ground. Remove power cord from the mains source by grasping the
plug. Do not pull on the cable.
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3 System introduction
3.1 Short description of the equipment
The CARESCAPE Monitor B650 is a modular multi-parameter patient monitor that is meant for
high-acuity applications.
The monitor can be used with most patient populations within a professional healthcare
facility, but acquisition modules may have limitations for use based on the patient’s age,
weight, or clinical condition, or on the type of the care unit (for example, OR or ICU only). There
are several types of acquisition modules to choose from based on care requirements and
patient needs.
The modular system design is inherent in electronics and algorithms: some processing of the
measurement signals is done by the acquisition modules and further processing happens on
the monitor.
Measurement values are displayed as graphic or numeric values, like waveforms and numbers,
and when applicable, also as alarm messages.
The monitor has a 15-inch display with an alarm light and it supports one slave screen. Screen
contents is user-configurable.
The user interface can be used as a touchscreen, or with a Trim Knob or a mouse and a
keyboard. The most important and commonly used functions have main keys either on the
main menu (soft keys) or on the monitor front panel (hard keys). The menu structure design
allows access to all functions needed by the clinical user with just a few clicks.
The monitor transfers the measurement data to central stations and to the hospital patient
data depositories. It communicates with a variety of other bedside medical devices and
monitoring systems, and it can also use a wireless network for interfacing.
For all physical and performance specifications, refer to the supplemental information
provided.
3.2.1 Monitor
The CARESCAPE Monitor B650 consists of a main unit and a pivoting module frame.
Main unit
The main unit consists of the following subsystems: power management, CPU, display, user
interface and external interfaces.
The power management subsystem provides the operating voltages for the electronics of the
device and takes care of the battery management. It consists of an AC/DC power supply, a
DC/DC power management board and an optional lithium-ion battery.
The CPU board is the main board of the monitor. It takes care of the user input and acquisition
data processing and displays the processed information on the screen. It controls the monitor
operation and communication with the other subsystems. It also interfaces with
synchronization connector, the optional WLAN card and the speaker. The main software and
all platform and clinical settings are stored in a detachable flash memory.
The display subsystem consists of a 15” touchscreen LCD display that has an integrated LED
backlight unit. The display controller is integrated to the CPU board.
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The user interface board provides an interface between the CPU board , Trim Knob control,
alarm light board and touchscreen sensor.
There are two different configurations of the interface board. They provide connectors for
peripheral devices like USB input devices, network interfaces, a secondary clone display and
other devices.
Module frame
The monitor has a pivoting module frame that includes standard docking for the following
multiparameter hemodynamic modules: Patient Data Module (PDM) and Patient Side Module
(PSM).
The E-module support extends the monitoring capabilities to other hemodynamic modules,
gas measurement, brain monitoring, and relaxation measurement. The optional integrated
recorder enables local printing to a thermal paper. The recorder option is also available as a
field upgrade.
3.2.2 Software
The patient monitor is highly configurable and provides many monitoring possibilities with a
flexible software licensing model.
The monitor supports care area specific software packages for OR, PACU, ICU, ED and NICU.
Each dedicated software package provides a comprehensive feature set for the different
monitoring needs and can be further extended with the optional feature licenses.
Software license model supports trial licensing and easy field upgrades with license key
activation.
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Keyboard
A washable, antibacterial keyboard is specified for
use with the monitor. It may be connected to the
monitor or display via one of the USB connectors.
The keyboard allows you to enter data without
using the touchscreen display.
Mouse
A standard mouse may be connected to the
monitor or display via one of the USB connectors.
The mouse allows you to select any on-screen
items without a Trim Knob control or a touchscreen
display.
Remote control
The remote control provides all patient monitor
controls on a portable component with a Trim Knob
control. The remote control is connected to the
patient monitor via one of the USB connectors.
Barcode reader
The barcode reader can be used to scan a
Technician ID and Patient Information from
barcodes when admitting patients.
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E-PSMP PDM
The integrated E-module slots can occupy two single-width or one double-width E-modules at
a time.
Refer to the patient monitor’s supplemental information manual for a list of compatible
acquisition devices and to the patient monitor’s user’s manual for a list of parameters each
module measures.
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The MC Network establishes communication and allows patient data to be sent to an optional
CARESCAPE Central Station.
The S/5 Network establishes communication and allows patient data to be sent to an iCentral
(central station).
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The Unity Network ID connectivity device acquires digital data from up to eight peripheral
bedside devices (not necessarily manufactured by GE), processes this data and transmits the
formatted data to the patient monitor.
The supported interfaces include anesthesia machines, ventilators, gas analyzers, continuous
cardiac output devices, pulse oximeters, transcutaneous monitors and point-of-care blood gas
monitors.
Refer to the Unity Network Interface Device (ID) Operator's Manual and the patient monitor’s
supplemental information manual for a list of compatible peripheral devices and to the patient
monitor’s user’s manual for the peripheral device parameter data displayed on the patient
monitor.
The secondary display is 19” touchscreen LCD with an abbreviated keypad and a Trim Knob
control. The secondary display shows visual alarms and provides connectivity to the USB input
devices.
Refer to the patient monitor’s supplemental information manual for a list of compatible
displays.
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Laser printers
A laser printer can print for example waveforms, graphic and numeric trends, snapshots,
events history, parameter specific printouts, stored laboratory data and calculation results and
care reports. Refer to the patient monitor’s user’s manual for more information about printing.
The patient monitor supports printing:
• to a laser printer that is connected to the patient monitor via the IX Network or directly to
the IX connector in the patient monitor.
• to a laser printer that is connected to a CARESCAPE Central Station on the MC Network.
• to a laser printer that is connected to an iCentral on the S/5 Network.
Recorders
A recorder may print text, waveforms and numeric trends.
The patient monitor supports printing:
• to an integrated, local recorder (optional).
• to a PRN 50M recorder connected to another patient monitor or to a CARESCAPE Central
Station on the MC Network.
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InSite RSvP
InSite RSvP provides a set of software applications to manage, diagnose and track systems at
customer sites by using the Internet for secure communications between the customers’ and
GE’s firewalls. InSite RSvP consists of Enterprise Server, which resides at GE’s support center,
and Remote Service Agent that resides on a system at the customer site (or on a PC controlling
the system(s) at the customer site).
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5 6 7 8 9 10
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MCID NA IX
ePort X3
1 2 3 4 5 6 7 8
MC
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IEC 60601-1-2
The system complies with IEC 60601-1-2:2007-03.
In accordance with IEC 60601-1-2, modules marked with the ESD warning symbol (IEC
60417-5134) require user training in ESD awareness and prevention as follows:
• The contents of the training are specified in the local ESD Control Program Plan, issued in
accordance with IEC 61340-5-1. The training should at least include an introduction to
ESD and its impacts on electrical devices and how to prevent it by using appropriate
personal protection equipment, proper work practices and tools.
According to parameter-specific IEC 60601–2–x series standard requirements for ESU
(electrosurgical unit) tests, the equipment is protected against malfunction caused by
electrosurgery.
IEC 60529
• Degree of protection against harmful ingress of water: IPX1.
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The characters used in the UDI marking represent specific identifiers. In the example above:
Device identifier:
• (01) = GS1 global trade item number (GTIN) of the device.
• 1234567891234 = Global trade item number.
Production identifiers:
• (21) = GS1 application identifier for the serial number of the device.
• SK412345678HA = Serial number, where the first three characters represent Product
Code.
• (11) = GS1 application identifier for the manufacturing date of the device.
• 151228 = Manufacturing date: year-month-day (YYMMDD).
Note that for some product types the production identifier can have other elements instead of
the ones listed above:
• (10) = GS1 application identifier for the batch or lot number, followed by the batch or lot
number.
• (17) = GS1 application identifier for the expiration date of the device, followed by the
expiration date.
Device label
Every GE device has a unique serial number for identification. The serial number is written in a
device label. A sample of the information on a device label is shown below.
The product code for CARESCAPE Monitor B650 VER02 is SS6, SK4, or SQC.
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System introduction
Authentication
Authentication is the process of proving individual identity, and is a key element in an access
control system. In the clinical and Webmin applications, there are certain features that require
user authentication. To access these features, the user must log into the clinical and Webmin
applications with a valid username and password.
Authorization
Authorization is the process of granting and revoking access to information, and is another key
element in an access control system. Although primarily an administrative process that is
driven by an organization’s policies and procedures, the patient monitor contains features that
will help implement and enforce an organization’s method.
Both clinical and Webmin applications have an authorization mechanism to provide
information to the user.
Audit
The ability to record and examine system activity is crucial to a successful information security
program, as well as a regulatory requirement in most environments. The patient monitor stores
system and Webmin access logs.
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The patient monitor performs integrity checking on the root file system to detect any
changes to the file system contents. Any modification to the root file system contents will
generate an error to the patient monitoring software application. The patient monitoring
software will then display a technical alarm to the user.
• Device design and configuration (hardening)
The patient monitor has been hardened through the restriction and removal of user
access to core operating system functionality. In addition, unneeded functionality has
been removed or restricted.
• Antivirus software
To provide seamless real-time patient monitoring, the patient monitor does not have
antivirus software.
• Security updates and patching processes
Security updates and patches cannot be applied to the CARESCAPE product without
going through GE’s vigorous software verification and validation process. Any software
update needs will be communicated by GE.
Packets that are part of the communication initiated by authorized devices in the
organization’s network are allowed to go out of the IX Network (reflexive).
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System introduction
Outbound
Source device Destination Device Protocol Destination port Use
Any icmp N/A ping
Patient
monitor
us1-ws.service.gehealthcare. tcp 443 InSite RSvP
com (Web Services)
us1-rd.service.gehealthcare. tcp 443 InSite RSvP
com (Remote Tunnel)
Printer tcp 631 Printing
MUSE tcp 80 MUSE
Packets that are part of the communication initiated by the patient monitor are allowed into
the IX Network (reflexive).
3.6.4 Communication
For detailed product security information, go to one of the following Web addresses:
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http://www.gehealthcare.com/usen/security
http://www.gehealthcare.com/usen/security/mds2.html
General alarm.
Do not reuse.
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Battery (PDM).
Communication. (PDM)
(black or red)
On/standby button.
USB connectors.
Ethernet connectors.
Serial interface.
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Color video input. Video input connector for digital or analog source.
Gas inlet.
Gas outlet.
Latex-free.
Use by.
Add date.
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Alternating current.
Green symbol on the B650 and B450 monitor front panel: the
monitor is being used on mains power. Without mains
connection the B650 and B450 are internally powered medical
equipment.
Direct current.
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Manufacturer date and address. The first four digits identify the
year, the following two digits identify the month, and the last two
digits identify the day.
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System introduction
Locked.
Unlocked.
No heavy load.
Temperature limitations.
Humidity limitations.
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Recyclable Lithium-ion.
Indicates that the product is certified for both the U.S. and
Canadian markets.
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Audio alarms paused indicator with countdown timer - Indicates all audio
alarms are paused and the amount of time remaining for the alarm pause
period displays as a countdown timer.
Pause audio alarms - Selectable from the monitor’s main menu. Also an
indicator of a temporarily paused active audio alarm.
Touch volume icon. Adjust the volume of the tone that sounds when a
user touches a touchscreen display.
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Monitor battery (green). The higher the charge, the bigger the green bar
within the symbol. Numbers indicate the remaining run time.
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PDM battery gauge indicator. Indicates the charge level of the battery.
PDM battery failure indicator. Indicates the battery is not available for use.
BIS and Entropy sensor impedance check indicator (gray). Displays for
each sensor as the impedance check is in progress.
BIS and Entropy sensor impedance check error indicator (red). Indicates
the specified sensor failed the impedance check.
BIS and Entropy sensor impedance check passed indicator. Indicates the
specified sensor passed the impedance check.
Completed NIBP volume icon. Adjust the volume of the tone that sounds
when an NIBP measurement result is available.
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NMT Stimulus beep volume icon. Adjust the volume of the tone that
sounds when a stimulus pulse is generated.
Progress bar. Indicates the amount of time remaining until the next
automatic measurement.
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Using Webmin service interface
Remote Webmin
You can access Webmin remotely from a configured service PC that is connected to the patient
monitor over the IX Network.
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Closing Webmin
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Using Webmin service interface
NOTE: If the IX IP address field is shown as 0.0.0.0., you need to configure the patient monitor’s
IX Network address first. Access Webmin using the integrated browser and configure a static IP
address for the IX Network.
4. Configure the service PC’s IP address and subnet mask to the same network segment
with the patient monitor’s IX Network setting.
NOTE: For more information on how to configure the IP address, refer to the PC’s
documentation.
5. Launch a web browser on the service PC.
6. In the Address field, type https://[IX IP address]:10000 and press Enter.
NOTE: [IX IP address] is the IX Network IP address of the patient monitor.
The Login to Webmin dialog box displays.
Closing Webmin
1. Restore the patient monitor’s original IX Network configuration and service PC’s network
settings if they were changed.
2. Disconnect the crossover cable from the patient monitor and from the service PC.
3. Reconnect the patient monitor back to the IX Network if applicable.
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6. Configure the service PC’s IP address and subnet mask to the same network segment
with the monitor’s MC Network.
NOTE: For more information on how to configure the IP address, refer to the PC’s
documentation.
7. Launch a web browser on the service PC.
8. In the Address field, type https://[MC IP address]:10000 and press Enter.
NOTE: [MC IP address] is the MC Network IP address of the patient monitor.
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Closing Webmin
1. You can exit the monitor’s maintenance mode any time by using the Trim Knob, using the
touchscreen or clicking a mouse button. The monitor will automatically restore the
original network configuration to the S/5 or MC Network and return to the normal
monitoring mode.
2. Restore the original network settings in the service PC.
3. Disconnect the crossover cable from the monitor and from the service PC.
4. Reconnect the monitor back to the S/5 or MC Network if applicable.
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IX Netmask: ______________________
4. Configure the service PC’s IP address and subnet mask to the same network segment
with the patient monitor’s IX Network.
NOTE: For more information on how to configure the IP address, refer to the PC’s
documentation.
5. Launch a web browser on the service PC.
6. In the Address field, type https://[IX IP address]:10000 and press Enter.
NOTE: [IX IP address] is the IX Network IP address of the patient monitor.
The Login to Webmin dialog box displays.
Closing Webmin:
1. Restore the original network settings in the service PC.
2. Disconnect the service PC from the live IX Network.
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Using Webmin service interface
Figure 1 Webmin user interface when accessed using the integrated browser
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The Webmin service interface includes the following configuration modules. Select Help for
additional information related to each Webmin module.
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Using Webmin service interface
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The Hardware Statistics module displays several internal voltages, temperatures and power
consumption.
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Ping a TCP/IP network device- Use this Webmin feature to verify connectivity with a network
device on the MC Network and IX Network.
Log files - The patient monitor collects information about different system events and errors to
log files. These log files help troubleshooting problems in the patient monitor and the
connected peripheral devices.
WLAN diagnostics- Use this Webmin feature for troubleshooting WLAN related problems. This
Webmin module provides information about the WLAN driver, WLAN status and the detected
access points.
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5 Pre-installation requirements
This chapter specifies the pre-installation requirements for the patient monitor.
5.1 Unpacking
1. Confirm that the packing box is undamaged. If the box is damaged, contact the shipper.
2. Open the top of the box and carefully unpack all components.
3. Confirm that all components are undamaged. If any of the components is damaged,
contact the shipper.
4. Confirm that all components are included. If any of the components is missing, contact
your GE Healthcare distributor.
WARNING EXCESSIVE LEAKAGE CURRENT - If the device has been transported or stored
outside operating temperature range allow it to stabilize back to operating
temperature range before removing it from the plastic bag.
CAUTION PACKAGING DISPOSAL - Dispose of the packaging material, observing the
applicable waste control regulations.
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WARNING The use of accessories, transducers and cables other than those specified
may result in increased emissions or decreased immunity performance of
the equipment or system.
WARNING For detailed instructions and information regarding supplies and
accessories, always refer to their own instructions for use.
5.3.1 MC Network
• The MC Network infrastructure shall be installed according to the CARESCAPE Network
Configuration Guide.
• The installation site of the patient monitor shall have a wall jack and a network patch
cable for the MC Network.
• Refer to the sections 7.2.2. Selecting and configuring CARESCAPE Network and 7.4. Setting
unit and bed name to see the configuration information you need to have available to
configure the patient monitor to the MC Network.
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• Refer to the sections 7.2.3. Selecting and configuring S/5 Network and 7.2.4. Configuring
WLAN to see the configuration information you need to have available to configure the
patient monitor to the S/5 Wireless Network.
5.3.5 IX Network
• The IX Network infrastructure shall be installed according to the CARESCAPE Network
Configuration Guide.
• The installation site of the patient monitor shall have a wall jack and a network patch
cable for the IX Network.
• Refer to the section 7.2.2. Selecting and configuring CARESCAPE Network to see the
configuration information you need to have available to configure the patient monitor to
the IX Network.
• Refer to the following sections for the information you need to have available for:
7.5. Configuring printers for IX printer configuration
7.6. Configuring MUSE/12SL
7.15.1. Configuring the remote service for InSite RSvP configuration.
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6 Hardware installation
CAUTION LOSS OF MONITORING - Leave space for circulation of air to prevent the
monitor from overheating. The manufacturer is not responsible for damage to
equipment caused by improperly vented cabinets, improper or faulty power, or
insufficient wall strength to support equipment mounted on such walls.
WARNING The parameter modules are not able to withstand unpacked drops from a
height of 1 m without damage. If a module is dropped, please service it
before taking it back into use.
WARNING After transferring or reinstalling the monitor, always check that it is
properly connected and all parts are securely attached.
WARNING SITE REQUIREMENTS - Do not route cables or tubing in a way that they may
present a stumbling hazard.
WARNING EXPLOSION - Do not use this equipment in the presence of flammable
anesthetics, vapors or liquids.
WARNING EXCESSIVE TOUCH CURRENT - To avoid excessive patient leakage current,
do not simultaneously touch the patient and the electrical connectors
located at the rear panel of the monitor, or within the module housing,
frames, or battery slot.
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2. Pull the battery tray out of the PDM using the battery tray strap.
3. Insert the battery with the TEST button facing up and the arrow pointing into the PDM.
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4. Press the battery door closed until it seals the battery compartment.
Install the patient monitor to the mounting hardware according to the installation instructions
included with the mounting hardware.
WARNING Never install equipment above the patient.
WARNING Use only manufacturer specified mounts.
WARNING To prevent liquids from entering the monitor, do not tilt the monitor more
than +-15 degrees. If the monitor is used as a stationary bedside monitor
with CARESCAPE respiratory modules or PDM, do not tilt it at all.
CAUTION The device/system should not be used adjacent to, or stacked with, other
equipment. Consult qualified personnel regarding device/system configuration.
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4. Secure the USB cables connections to the displays according to the instruction included
in the display package.
NOTE: A USB hub should not be used to connect the USB touchscreen to the patient monitor.
B) Cable length is 5 to 15 meters
If complete isolation is not required, this method will provide the most cost effective means of
extending your USB installation. This type of installation should not be used for connections to
non-medically used rooms according to IEC 60601-1.
Displays may be extended up to 15 meters from the patient monitor using the following cables:
15-meter DVI-I to DVI-I video cable (p/n 2042766-001).
5-meter USB extender (p/n 2042768-001)
Standard USB-A to USB-B cable, up to 5 meters.
Type A receptacle
In the following example, two 5-meter USB extenders, plus a standard 5-meter USB cable
extend the remote display up to 15 meters from the patient monitor.
Remote
CARESCAPE Monitor B650
display
A B
C D
A to D = DVI-D connection
B to C = USB remote (2 USB extenders required)
USB-connection:
1. Connect the Type A plug of the 1st USB extender to one of the downstream ports (Type A
USB port) on the back of the patient monitor.
2. Connect the Type A plug of the 2nd USB extender to the Type A receptacle on the 1st USB
extender.
3. Connect the Type A plug of the standard USB cable to the Type A receptacle on the 2nd
USB extender.
4. Connect the Type B plug of the standard USB cable to the upstream port (Type B USB port)
on the bottom of the display.
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5. Secure the USB cables connections to the displays according to the instruction included
in the display package.
Video cable:
Connect one end of the 15-meter DVI-I to DVI-I video cable to the DVI-I connector on the
bottom of the display and the other end to the DVI-I connector on the back of the patient
monitor.
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Mounting options include mounting to a bed headboard or footboard, an IV pole, or a roll stand
using one of the docking stations. Mounting kits include all necessary hardware and
installation instructions. Ensure that the selected PDM mount is properly installed according to
the installation instructions included.
1. Connect the PDM module to installed mounting hardware as instructed in the
accompanying installation instructions.
2. Connect one end of the ePort cable to the PDM module ePort connector.
3. Connect the other end of the ePort cable to the ePort connector in the rear panel of the
patient monitor.
NOTE: The PDM module can be installed into a pole mount only if the monitor is equipped with
the Advanced Interface Board that provides the ePort connector.
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CAUTION POWER REQUIREMENTS - Before connecting the device to the power line, check
that the voltage and frequency ratings of the power line are the same as those
indicated on the device's label. If this is not the case, do not connect the system
to the power line until you adjust the device to match the power source. In
U.S.A., if the installation of this equipment will use 240V rather than 120V, the
source must be a center-tapped, 240V, single-phase circuit. This equipment is
suitable for connection to public mains as defined in CISPR 11.
If a non-medical grade display is used as a display within the patient environment it must
always be powered from an additional transformer providing at least basic isolation.
1. Connect power cords to the mains power supply inlet and to a wall outlet on all system
components that require AC mains power input.
2. Do not power on any devices.
NOTE: Be sure that all power cords are securely connected and that they are routed through
the retaining clips or cable clamps, as applicable.
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NOTE: Refer to the iCollect User's Manual for more information about the iCollect.
NOTE: Contact GE Healthcare Service to get more information about interfacing other data
acquisition systems to the patient monitor.
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NOTE: Connection to a local printer is possible only if the monitor is equipped with the
Advanced Interface Board that provides an IX Network connector.
NOTE: If the local printer is used within the patient environment it must always be powered
from an additional transformer providing at least basic isolation.
NOTE: Refer to the printer manual on how to install and configure the printer. The printer shall
be configured to communicate in the same subnet with the patient monitor’s IX Network
settings.
WARNING EXCESSIVE LEAKAGE CURRENT - Laser printers are UL 60950/IEC 60950
certified equipment, which may not meet the leakage current requirements
of patient care equipment. This equipment must not be located in the
patient environment unless the medical system standard IEC 60601-1 is
followed. Do not connect a laser printer to a multiple socket outlet
supplying patient care equipment. The use of multiple socket outlet for a
system will result in an enclosure leakage current equal to the sum of all the
individual ground leakage currents of the system if there is an interruption
of the multiple socket outlet protective earth conductor.
WARNING Non-medical equipment does not provide the same level of protection
against electrical shock. Do not touch the patient and any part of
non-medical equipment at the same time. Some examples of non-medical
equipment are laser printers and non-medical computers.
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Configuration
7 Configuration
The configuration of the patient monitor consists of platform configuration and clinical
configuration.
This chapter describes how to perform the platform configuration tasks needed to take the
patient monitor into use for the first time and the configuration tasks needed for administration
and maintenance thereafter.
For information on how to perform the clinical configuration, including care unit settings and
user profiles, refer to the patient monitor’s user’s manual.
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NOTE: The following IP addresses are reserved for the monitor’s internal use: 192.168.249.x,
192.168.250.x, 192.168.252.x, 192.168.253.x, 192.168.254.1 and 192.168.254.2.
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1. In the Network Configuration window below S/5 Network, enter a Virtual ID.
NOTE: Valid values are within the range of 50000 to 55000, inclusive.
NOTE: The Virtual ID must be unique for each patient monitor connected to the S/5 Network.
2. Below IX Network, select DHCP or Manual Configuration.
a. Enter a Static IP address.
b. Enter a valid Netmask level.
c. Enter a valid Default Gateway.
d. Enter valid DNS Server addresses if applicable.
3. Select Save.
The S/5 virtual ID change will be applied immediately. All other network configurations will be
saved and become active after the patient monitor is restarted.
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1. Log in to Webmin.
2. Select Configuration > WLAN. The current status of the WLAN radio is shown below the
Current State in the WLAN Configuration window.
3. Select Enable as a New State to enable the WLAN radio.
NOTE: If the WLAN radio is disabled, the WLAN radio is turned off.
4. Select Antenna as Enabled to enable both the internal antennas.
NOTE: Antenna diversity is a method used to assist in compensating for multipath interference.
When set to Enabled, Antenna Diversity monitors the signal from each antenna and
automatically switches to the one with the better signal.
5. Configure the appropriate WLAN settings. Note that the configurable attributes and
available values are different for MC Network and S/5 Network.
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QoS Configuration Select the Quality of Service (QoS) Select QoS configuration setting as specified in
standard used in the wireless the wireless network design.
infrastructure to prioritize the NOTE: This option is not configurable in S/5
network traffic: Wireless Network.
- None (no QoS in use)
- WMM (WLAN Multimedia in use)
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only if the patient monitor is not connected to the S/5 Network and the patient monitor is in a
discharged state.
CAUTION NETWORK DEVICE TIME SYNCHRONIZATION — When adding a new device to
the CARESCAPE Network, the existing devices on the CARESCAPE Network will
synchronize to the new device’s time. To prevent potential time
synchronization issues, you should set the new device’s time to be as close as
possible to the time (within one minute or less) used by the existing GE devices
on the CARESCAPE Network.
1. Log in to Webmin.
2. Select Configuration > Time.
3. In the Time Configuration window, in Configure Date and Time, update the following
fields as needed:
• Date
• Month
• Year
• Hour:Minute
• AM/PM
• 12/24 Hrs
4. Select Save.
The manual time configuration takes effect immediately.
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NOTE: Laser printers that are installed on central stations do not need to be configured using
Webmin. Refer to the user’s manual for details on configuring the printer.
NOTE: This Webmin module is available only if the monitor is equipped with the Advanced
Interface Board that provides both the MC and the IX Network interfaces.
NOTE: Refer to the patient monitor's supplemental information manual for the list of supported
devices.
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4. Select Save.
These settings take effect immediately after they are submitted.
4. Select Save.
These settings take effect immediately after they are submitted.
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The temporary patient ID prefix is a hospital defined prefix that is used as the first two
characters in a temporary patient ID to ensure its uniqueness inside the hospital.
1. Log in to Webmin.
2. Select Configuration > Admit Settings.
3. In the Sub-Modules for Admit Settings menu, select Patient ID Prefix.
4. In the Patient ID Prefix window, enter a 2-character prefix.
NOTE: Valid values are uppercase letters and numbers.
5. Select Save.
All changes take effect immediately.
2. Select Save.
If you selected No Parser, the barcode setting configuration is complete.
For a Length or Character Delimited Parser, follow the applicable instructions.
7.7.3 Configuring length delimited parser information.
or
7.7.4 Configure character delimited parser information.
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1. Log in to Webmin.
2. Select Configuration > Power Frequency.
3. In the Power Frequency window, select the applicable power line frequency.
4. Select Save.
The power frequency configuration takes effect immediately.
4. Select Save.
The national requirements changes take effect immediately.
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5. Select Save.
The changes will take effect immediately.
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Save the completed platform and/or clinical settings to a service PC or USB flash drive.
1. Log in to Webmin.
2. Select Configuration > Settings.
3. In the Sub-Modules for Settings menu, select Save.
4. In the Save Settings window, select the radio button next to the type of settings you want
to save.
5. Select Save.
6. According to your Webmin access:
a. If you are using Webmin on a service PC, you can save the settings file to any mass
storage device connected to the service PC:
In the File Download dialog box, select Save.
In the Save as dialog box, select the destination drive and folder and select Save.
NOTE: You may change the default filename, but do not change the file extension.
b. If you are using Webmin locally through the integrated browser, you can save the settings
file to a USB flash drive that is connected to one of the patient monitor’s USB ports:
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The Save As window will show you the name of the created settings file.
Select Save to save the settings file to the USB flash drive.
NOTE: You may change the default filename, but do not change the file extension.
NOTE: Do not disconnect the USB storage device until saving is complete.
NOTE: As a factory default the ICU software package is always activated.
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• Select Cloned settings (clinical and platform) to activate both the clinical and
platform settings.
• Select Cloned clinical settings to activate only loaded clinical settings.
• Select Cloned platform settings to activate only loaded platform settings.
NOTE: Activation of the cloned clinical or platform settings will not affect the following
settings in the target patient monitor:
Network
Unit and Bed Name
Host Asset Settings
Licenses
Remember to configure the unaffected settings manually in the target patient monitor.
NOTE: Check and manually modify the following WLAN settings after activating them in
the destination monitor:
RTS Threshold
Fragmentation Threshold
TXOP for Best Effort
TXOP for Background
• Select Factory default settings to restore all platform and clinical settings back to
the factory defaults.
• Select US default clinical settings to restore all clinical and platform settings back
to the US specific factory defaults.
NOTE: Activation of the factory defaults and US factory defaults will leave the following
settings in the target patient monitor unaffected:
- Host Asset Settings
- Licenses
5. In the Setting Activation, select whether you want the new settings to take effect
immediately or after the next case end / discharge:
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Select To NOTE
Immediately Activate the new settings The patient monitor must be in a
Immediately. case reset / patient discharged state.
After next case end / Take the new settings in use This option allows you to initiate the
discharge with a delay, after the next setting activation process with a
case end / patient discharge. delay during an active patient case.
The new settings will activate only
after the next case end / patient
discharge.
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• Confirm Password: Re-enter the password for the private key/certificate. NOTE. You
must enter the password each time that an SSL service that uses this key is started.
If you do not want to provide the password for each service, leave the Password
field blank.
• Key size: Enter the RSA key size in bits (default: 2048).
• Certificate valid for: Enter the number of days before the certificate expires (default:
730)
• Common Name: Enter the name of the host device (default: hostname of the
device).
• Organization Name: Enter the name of the hospital requesting the certificate/key.
• Locality: Enter the locality information (for example, city).
• State or Province (full name): Enter the state or province information.
• Country: Enter the 2-letter country code.
• Email Address: Enter the email address of the hospital requesting the
certificate/key.
4. Select Generate Key to generate a self-signed certificate and private key.
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2. Select Configuration > Certificate management > Import Key or Signed Certificate.
3. To upload the certificate file:
a. In the Certificate file to upload field, select Choose file, search the drive and folder
where the file is located, and select the file you wish to upload. Follow the
instructions of the web browser.
b. In the Destination directory of certificate field, select the destination directory for
uploading the certificate file.
c. Enter the name of the certificate to the Destination filename of certificate field.
d. Select Upload Certificate to upload the certificate file to the host device.
4. To upload the key file:
a. In the Key file to upload field, select Choose file. Search for the drive and folder
where the file is located and select the file you wish to upload. Follow the
instructions of the web browser.
b. In the Destination directory of key field, select the destination directory for
uploading the private key file.
c. In the Destination filename of certificate field, enter the name of the private key.
d. Select Upload Key to upload the private key file to the host device.
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• GE Healthcare Software Transfer Utility that runs on a service PC. With this application,
you can transfer new software to the patient monitors over the CARESCAPE Network IX (IX
Network) or a crossover cable.
• InSite RSvP
You can transfer the software in the background, without affecting normal patient monitoring.
The new, transferred software is inactive in the patient monitor(s) until you activate it.
NOTE: The software installation package contains both the patient monitor software and the
Software Transfer Utility. The software transfer procedure is described in detail in the
CARESCAPE Modular Monitors Software Installation Instructions that is delivered together with
the software installation package.
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4. Select Next.
The selected Software activation window appears.
5. According to the software you are activating, proceed to:
• Activating host software immediately
• Activating host software after next case end / discharge
• Activating module software
1. In the Host Software window, verify that the software you are activating is listed as
Inactive in Current Software State.
2. In Software License, if applicable, enter the Activation Code for the new software
version.
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1. In the Host Software window, verify that the software that you activate is listed as
Inactive in Current Software State.
2. In Software License, if applicable, enter the Activation Code for the new software
version.
3. In Software Activation, select After next case end / discharge.
4. In Erase Inactive Software After Activation, select:
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The software activation starts automatically after the clinical user performs a patient
discharge / case end the next time. The patient monitor shows a screen saver that informs
about the ongoing software activation:
Software activation in progress. Do not disconnect any measurement modules or other
peripheral devices, or shut down the monitor until the software activation is complete.
Activation may take up to 10 minutes. The device will automatically restart once the
software activation is complete.
NOTE: When the software is activated first time after a uDOM replacement, the screen saver
does not appear.
The clinical user must wait until the software activation is complete and the patient monitor
restarts automatically. If the patient monitor starts up normally and no error messages appear
on the display, the activation is successful.
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3. Select Host Software from the Software List and select Next.
4. In the Host Software window, below Status, verify that the Software activation pending
is Yes.
5. Select Cancel.
The pending software activation is cancelled and the patient monitor continues running the
current software version.
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8 Installation checkout
The purpose of the installation checkout procedure is to ensure that the system is properly
installed and configured for use.
The installation check covers the CARESCAPE B650 monitoring system including the following
devices:
• CARESCAPE B650 host
• Displays
• E-modules
• CARESCAPE PDM
Service personnel shall perform the following checkout procedure for the monitoring system
after the hardware installation and platform configuration is completed:
• 8.1. Visual inspection
• 8.2. Electrical safety tests
NOTE: The manufacturer has performed the electrical safety test for the patient monitor
and acquisition modules during final inspection. You do not have to perform the electrical
safety tests during installation checkout, if there is less than 12 months since the patient
monitor was manufactured. Check the date of manufacture of the device from the device
label (see section 3.5.2. Equipment identification).
• 8.3. Functional check
NOTE: Refer to chapter 10. Maintenance and checkout to see the recommended checkout
procedure after corrective and planned maintenance.
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Perform electrical safety tests using an electrical safety analyzer according to IEC 60601-1,
AAMI ES60601-1 + C1 + A1 + A2, EN 60601-1 or CSA CAN/CSA-C22.2 NO. 60601-1:14. The
schematics in this section provide a general understanding of the test equipment. Actual
configuration of test equipment may vary. Refer to the instructions delivered with the safety
analyzer to perform each test.
The patient monitor being tested should be placed on an insulating surface.
NOTE: Before proceeding, make sure that all test equipment is properly calibrated, maintained
and functioning.
NOTE: GE recommends that the qualified personnel performing the tests should record the test
results of each electrical safety test, for example by using the installation / maintenance check
forms included in this manual.
System setup
These instructions are intended for every component in the system. Ensure that all system
components are properly connected to the patient monitor.
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Acceptance criteria:
• For equipment without a power supply cord, the impedance between the protective
ground terminal and any accessible metal part which is protectively grounded shall not
exceed 0.1 ohms.
• For equipment with a power supply cord, the impedance between the protective ground
pin in the mains plug and any accessible metal part which is protectively grounded shall
not exceed 0.2 ohms.
2. The voltage drop between the parts described is measured and the impedance
determined from the current and voltage drop. It shall not exceed the values indicated.
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When taking this measurement, flex the unit’s power cord along its length. There should
be no fluctuations in resistance.
Acceptance criteria:
• For equipment without a power supply cord, the impedance between the protective
ground terminal and any accessible metal part which is protectively grounded shall not
exceed 0.1 Ohms.
• For equipment with a power supply cord, the impedance between the protective ground
pin in the mains plug and any accessible metal part which is protectively grounded shall
not exceed 0.2 Ohms.
NOTE: *The measuring device (MD) represents the network and voltage measuring instrument
and its frequency characters according to IEC 60601-1.
3. Read and record the current leakage indicated on the safety tester.
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5. Read and record the current leakage indicated on the safety tester.
7. Read and record the current leakage indicated on the safety tester.
9. Read and record the current leakage indicated on the safety tester.
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NOTE: *The measuring device (MD) represents the network and voltage measuring instrument
and its frequency characters according to IEC 60601-1.
3. Read and record the current leakage indicated on the safety tester.
5. Read and record the current leakage indicated on the safety tester.
7. Read and record the current leakage indicated on the safety tester.
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9. Read and record the current leakage indicated on the safety tester.
11. Read and record the current leakage indicated on the safety tester.
13. Read and record the current leakage indicated on the safety tester.
Acceptance criteria in Single Fault Condition (SFC) – earth open or one of the supply conductors
open at a time:
• All readings shall be less than or equal to 300 A for installations that require compliance
to UL 60601-1 requirements.
• All readings shall be less than or equal to 500 A for installations that require compliance
to EN 60601-1 / IEC 60601-1 requirements.
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Perform the test in Normal Condition (NC) and in two different Single Fault Conditions (SFC):
1) earth open and 2) one of the supply conductors open at a time.
Perform test with normal and reverse polarity.
NOTE: Refer to the instructions delivered with the safety analyzer to perform this test.
NOTE: *The measuring device (MD) represents the network and voltage measuring instrument
and its frequency characters according to IEC 60601-1.
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NOTE: Perform this test for all the connected parameter modules and patient connectors
specified in Table 1.
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NOTE: Refer to the instructions delivered with the safety analyzer to perform this test.
NOTE: *The measuring device (MD) represents the network and voltage measuring instrument
and its frequency characters according to IEC 60601-1.
NOTE: **According to IEC-60601, the impedance to protect the circuitry and the person
performing the test, but low enough to accept currents higher than the allowable values of the
leakage current to be measured.
WARNING SHOCK HAZARD - The following step causes high voltage at the test body.
Do not touch the test body.
NOTE: Perform this test for all the connected parameter modules and patient connectors
specified in Table 1.
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7. Repeat this test for all the connected parameter modules and patient connectors
specified in Table 1.
Acceptance criteria:
• All readings shall be less than or equal to 50 A.
8.3.1 Start-up
1. Connect the power cord to the wall outlet.
2. Turn on the patient monitor and perform a cold start.
NOTE: The patient monitor performs a cold start, when the monitor has been off for more than
15 minutes. You can force the patient monitor to perform a cold start earlier by detaching the
monitor battery and disconnecting the power cord from the wall outlet for a moment before
turning the monitor on.
Verify that the patient monitor starts up normally:
The yellow, red and blue alarm lights are lit momentarily.
The speaker gives an audible beep.
The normal monitoring screen appears and there are no error messages on the
screen.
Monitors with battery option: The battery symbol on the upper right corner of the
screen indicates that the monitor battery is fully charged or charging.
NOTE: Before taking the patient monitor into use for the first time, the battery should be fully
charged. Keep the monitor connected to the mains until the battery is fully charged.
NOTE: Refer to section 10.4. Monitor battery maintenance to see the procedure for battery
conditioning and battery replacement, if you receive a Battery Failure message.
8.3.2 Display
Picture quality
Perform this test both for the integrated main display and for the optional secondary display.
1. Verify that all text is readable and all images are clear.
2. Verify that the brightness is good. Adjust if necessary.
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Touchscreen control
Perform this test only if the integrated main display or the optional secondary display is a
touchscreen.
1. Verify the operation and the calibration of a touchscreen by touching a corner of an
active parameter window. Verify that the selected menu is opened.
2. Select to close any open menu and return to the main display.
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the Trim Knob control once to select the highlighted option. Verify that the selected
menu is opened on the screen or the selected activity is started.
3. Select to close any open menu and return to the main display.
8.3.6 Mouse
Perform this test only if a mouse is connected to the patient monitor.
1. Move the mouse until the pointer (arrow) is over an active parameter window or a main
menu item you wish to select and click the left mouse button once to select it.
2. Select to close the open menu and return to the main display.
5. Select to close the open menu and return to the main display.
7. Select to close the open menu and return to the main display.
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NOTE: Make sure that at least one other patient monitor is on the network. The other patient
monitor must be in an admitted state and have an active ECG measurement with a simulator
signal.
1. Check that a network symbol is displayed in the upper right corner of the
screen.
2. Select Data & Pages – Other Patients and select a patient from the list.
3. Select View and verify that a window with parameters from another patient displays on
the left side of the screen.
2. Check that the wireless network symbol and the signal strength symbol are shown
and that the signal strength is adequate.
3. Select Data & Pages – Other Patients and select a patient from the list.
4. Select View and verify that a window with parameters from another patient displays on
the left side of the screen. Check that the waveforms are continuous and there is no data
loss.
6. Log in to Webmin.
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8.3.11 IX printers
Perform the following test only if the patient monitor is connected to a printer in the IX Network
and you did not print a test page while you configured the IX printer.
1. Log in to Webmin.
2. Select Configuration > Printers > Print Test Page.
3. Select the IX Printer to test.
4. Select Save.
5. Verify that the test page was printed to the selected printer.
6. Repeat steps 3 to 5 for all connected IX printers.
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9
CARESCAPE Monitor B650 System Diagram
TrimKnob
Speaker for Encoder
power failure
Alarm Cable
Alarm Light Board User Interface Board
Figure 3
WLAN uDOM
Unit Tranceiver User Interface USB Disk On
CF Card Cable Module
AC/DC Cable
15.7V +/ -2% Power Management Controller (PMC)
Serial Interfaces
DC/DC Cable
Power path switches
Ethernet Interfaces
DC/DC Board Smart Battery charger
Card Bus Interface Advanced Interface Board
5V buck
3.3V buck Ethernet Module Bus Controller (EMBC) USB Power Switch
12V buck/boost Module Bus Interface DVI-I Filter & ESD Protection
15Vmod buck/boost Recorder interface Ethernet Switch
Theory of operation
Smart Battery Battery Pow & Chg LED drive Defib & IABP Sync Interface Ethernet PHY
+5Vpmc linreg
Connector I2C A/D
Li-ION Psys & Pmod meas.
Battery Cable
Hinge Flex Board
PDM Docking
Recorder
2 x D25 E-Module
Connector 10-pin ePort 5-pin PSM
Connector Connector
The system block diagram describes the functional units of the CARESCAPE Monitor B650.
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The following sections describe the operation and interaction of the different subsystems.
AC/DC
DC/DC Cable
Rs = DC/DC BOARD
Connnector
Li-ION
Battery
Cable
SMART BAT
BATTERY
SMBus
9-12.3V
POWER
POWER
PATH
PATH
CONTROL
Power Path SWITCHES
IC
control signals
POWER_IN
VSYS ACDC VSYS CIRCUIT
BREAKER
SYS_CURRENT MOD_CURRENT
DC/DC Board
control signals
PMC CPU 15Vmod
LED control LED 3.3V 5V 12V
& BUCK/
DRIVE BUCK BUCK BUCK/BOOST
A/D ch's ON/STBY Control signals BOOST
02_PowerSupp_DCDC_Blk_Diag_M1058826_00
LOGIC to other boards
Backlight
Cable
Cpu Board Connector Cpu Board Connector
Connector
15Vmod &
SERIAL & I2C COMM. Front Panel +3.3V +5V +12V +15VMOD VSYS
ePort VSYS
ON/STBY CTRL Pow and Chg
B650-
1.vsd
Circuit
REMOTE_ON LEDs
Breakers
Battery
The patient monitor has one optional, rechargeable 11.1 V, 6210 mAh lithium-ion battery,
located in the battery compartment.
The battery cable connects the battery board to the DC/DC board. The battery pack supports
Smart Battery Data and it communicates with the DC/DC board using the System Management
Bus (SM Bus). Battery management is handled by the DC/DC board.
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Theory of operation
If there is a power failure (e.g., the supply mains is interrupted or the USB cable is
disconnected), the CARESCAPE D19KT VER01 display gives a continuous beeping alarm. This
alarm remains active for as long as there is some residual power left, or until it is silenced with
the Trim Knob or the standby button, or until the USB cable is reconnected or the supply mains
is restored. A power failure alarm is also indicated by the alarm light flashing yellow.
DC/DC Board
There are two versions of the DC/DC board: one for models with the optional battery and one
for models without battery. The non-battery version excludes the electronics needed for
battery charging and power path management.
The DC/DC board converts the output voltage of the AC/DC power supply, or the battery
voltage, to the following supply voltages:
• To +3.3 V supply voltage for the CPU board, LCD display, user interface board and the
standard/advanced interface board using a step-down converter.
• To + 5 V supply voltage for the CPU board, user interface board and the
standard/advanced interface board using a step-down converter.
• To +12 V supply voltage for the optional recorder and the LED backlight of the display
using a buck-boost converter.
• To + 15VMod supply voltage for the PSM module and the E-Module interface board using
a buck-boost converter. This converter is omitted in the non-battery models, where the
+15VMod power line is connected directly to the VSYS voltage.
• It passes the 8.7 -16 V (in AC/DC use 14.9-16 V) VSYS supply voltage for the E-Module
interface board, the 10-pin ePort connector in the PDM docking station and for the DB9
ePort connector in the advanced interface board. The power supply is capable to supply
VSYS voltage only to one ePort connector at a time.
• All supply voltages have over-voltage and short-circuit protection.
The DC/DC board takes care of the battery charging and controlling of the power path
switches. The power path switches select either AC/DC output voltage or battery voltage as the
DC/DC board input source.
The DC/DC board PMC CPU (Power Management Controller) controls power supplies'
sequencing. It measures board temperature and voltages by an internal A/D converter. System
and module currents also are measured and the corresponding power consumptions
calculated. PMC communicates with the CPU board via serial communication and with the
battery and battery charger IC via SM Bus. I2C bus (Inter-Integrated Circuit) is used for
communication with the A/D-converters and temperature sensors on the other boards of the
patient monitor.
The smart battery charger acts as an SM Bus slave device that responds to charging current
and charging voltage requests received via SM Bus. The charging requests are not sent directly
by the smart battery, but by the PMC CPU, which first asks the values from the battery. The PMC
may reduce or stop charging current if needed from the system point of view, i.e., if system
power consumption or temperature would get too high. The smart battery is responsible for
the charging algorithm and capacity calculation.
The battery charger has input current HW-limit feature. In a case where the input current
would exceed the limit, the charger reduces the output current to keep the input within the
limit. The AC/DC current for the whole system is taken through this current measurement as
well. This results in the charger reducing its output current if the sum of the charger input
current and system current exceeds the input limit. The purpose of this is to prevent the AC/DC
power source from getting overloaded if system power rapidly increases during charging.
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Cooling
The patient monitor uses convection cooling. The ventilation openings of the device are located
in the rear of the monitor and below the front unit
The AC/DC power supply unit has a heat sink that is mounted to the aluminum rear unit
assembly to enhance cooling of the power supply.
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X14 X17 X11
LVDS panel X2 I/O board connector Speaker CF-card
connector out WLAN
Current
Class D
+5V
sense
+3.3V
VSYS
Audio
SPI
Analog
Amplifier +5V Power
PMC_I2C
Amplifier Power
USB4
MAX4073 +3.3V switch
MDC/MDIO
MAX9759
REMOTE_ON/
24-bit Digital
TPS
+5V 2223A
LVDS
Amplifier LP filter
AUDIO_FB
OPA342
VDD_LCD
FP Bus signals
+3.3V VDD
Flat panel VDD control
switch
Figure 4
Display controller USB2 USB audio
VSYNC to inverter Silicon Motion USB 2.0 codec Cardbus
+1.5V USB3 PCM2901
Lynx3DM+ Controller controller
+1.8V SM722 uPD720101 USB1 +3.3V PCI1520
Power
9.1.2 CPU subsystem
Reg/Gnt0
Reg/Gnt2
Reg/Gnt1
PCICLK1
PCICLK3
100 CLK_SDRAM +3.3V
PCI bus PCI
MHz
100 MHz interface
MPC9448
CLK buffer
CLKIN PCI arbitrator signals
33 MHz 32-bit
+3.3V
33 MHz Clock
CLKOUT
buffer
3V, 125mAh FB CY2309
+1.5V/1.8V/2.5V/3.3V Feedback
G7
VBAT +3.3V
PORESET
Lithium Reset Power_on reset
LTC2900
Watchdog
Battery PORESET
Watchdog
WD_KICK X12
MAX793 SDRAM Boot FLASH
PFAIL/
+3.3V/VBAT 16 MB 16-bit uDOC
BATTERY_OK 512 MB 64-bit
BRIGHTNESS I/O 1 chip connector
8 chips
EN_BACKLIGHT K4S511632M 28F128J3A
+3.3V (P30 series uses 1.8V)
POW/BATTERY_LEDS
60x bus +3.3V +1.8V/
interface +3.3V
ON/STBY_BUTTON
Power management, LVTTL, 19200 2-wire serial port 100 MHz 64-bit
RXD_TO_PMC & TXD_FROM_PMC SMSER2_TXD & SMSER2_RXD
SMC2
Buffer
~CS2
~CS0
60x bus
60x bus
~CS1 &
REMOTE_ON/ uSSD
CLK_SDRAM
Bus
signal Modular Flash Disk
PD_RDY
buffers 1 GB
+3.3V MDD1675-D32-P
+5V
Chip selects +5V
+12V
MPC8270
enables
PMC_I2C
I2C
+3.3V
frame board
PHY FCC3 I/O
X13 connector user interface
10/100Base-T
2x Modbus DP83848 Transmit & Receive clocks
Transformer
I/O: CLK15 & 16
X3 Connector to Module
4-wire serial to Rec POW/BATTERY_LEDS
+3.3V
PORESET
MODBUS_PSM SMC1
MODBUS_EMOD
Watchdog
RS-485 Boot FLASH
MAX823
buffers Atmel SCC4
REC_RESET Buffer 2x Serial
Max3486E AT45DB011B
REC_READY +3.3V 2-wire serial port
REC_PRESENT +3.3V +3.3V
SCC1 SER1_TXD & SER1_RXD
SPI
Reset
X9 Serial
connector
X4
I/O
Atmel I/O: CLK13 & 14
AT91RM9200
connector
SPI
ARM9 JTAG
COP/JTAG signals
16 JTAG Port
X1
+1.5/3.3V
Development
Analog
IBP_ANALOG_OUT NAND FLASH control
interface
CS1
MARKER_OUT block ARM bus
+1.5/1.8/2.5/3.3/5/+12V/-12V/VSYS SPI ADC +
MARKER_IN SPI
temp sensor SPI DAC BRIGHTNESS
+3.3/+12V/-12V SDRAM
NAND FLASH
64 MB 32-bit AUDIO_FB ADT7411
ANALOG_OUT_REF 32 MB 8-bit
sync. connector
2 chips 2072926-001 CPU block diagram.vsd
SPI
+3.3V +3.3V
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Indicator
LEDs
ON/STBY
+3.3V
LEDs
G_BAT_LED_PT
+3.3V_SC +3.3V
connector
+3.3V IRQ0
Smith-Trigger
buffers
Trimknob direction signal B TKNOB_B
+5V IRQ1
Trimknob pushbutton TKNOB_PB
+3.3V ~HUB_RST I/O
MAX823 +3.3V
POWER_FAILURE_VISUAL_ALARM
PWM1
connector
TI TUSB2036
XTAL LQFP32 +3.3V_SC RED_ALARM
~HUB_RST
6MHz
+3.3V CYAN_ALARM
(full speed)
ALARM_EN1 Mux
USB
I/O +3.3V_SC
MAX4634
X401 Touch Screen
ALARM_EN2
I/O +5V
connector
X204 JTAG
connector
2-wire debug serial port
LIGHT_SENSOR_AD ADC SERIAL
~JTAG_RST
+3.3V_SC
LDO Regulator +2V Step-up DC/DC
+3.3V +3.3V_SC
LT1963A converter
Supercapacitor
10F, 2.5V
Current
limitter
Touchscreen sensor
The patient monitor has a resistive touchscreen sensor in the front of the LCD panel. The
touchscreen sensor detects the presence and location of a touch within the display area and
communicates the information to the touchscreen controller.
Trim Knob
The Trim Knob control is a rotary-switch with a push selection operation. The Trim Knob
encoder detects the direction of the Trim Knob rotation and push button use and passes that
information to the CPU board via the user interface board.
Speaker
The main speaker is used to provide audible alarms. The speaker cable is connected directly to
the CPU board. The audio signal for the speaker is generated in the CPU board using a tone
generator and an audio amplifier. Audio feedback controls the operation of the speaker.
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The external connectors have ESD protection. RJ-45 connectors provide isolation.
FM2OPTIO board
Remote On
28.08.2009
X5
Remote_ON
M1059909 USB1
Filtering
and
USB2 ESD
protection
Filtered
USB1
Dual USB
MIC2026
Serial
2 x 500 mA
X3
I2C EEPROM +5V Filtered
current limit USB2
I2C
SPI USB3
Filtering
and
Remote_ON USB4 ESD
protection
High Speed
USB4 from FM2CPU
USB HUB Filtered
USB3
Dual USB
MIC2026
X2 CPU board connector
VSYS
2 x 500 mA
X4
+3.3V / +5V +5V Filtered
+3.3V
current limit USB4
2.1A current
limit with
+5V +5V_limited
ADM1170
Hot swap +5V
controller TMDS differential data lines Filtered TMDS
Filtering
DVI-I
Sil164
X1
and
24-bit Digital bus
PanelLink ESD
Filtered analog
Transmitter protection
Analog +3.3V
Temp sensor
I2C &
AD-converter
Eport
Ethernet switch
X7
Magnetics
BCM5325(E) 10Base-T
SPI
D-SUB9
+1.8V / +3.3V
Magnetics
10/100Base-TX
10/100Base-TX
Indicator
LEDS
Dual stacked CAT5
connector
Indicator
LEDS
10/100Base-TX
10/100Base-TX
Synchronization connector
The synchronization connector provides analog ECG and invasive pressure outputs and a
digital marker-out signal for external user-supplied equipment, e.g., a defibrillator or an
intra-aortic balloon pump. This connector does not operate with the PDM module.
See Synchronization connector test in Maintenance chapter for details about the pin layout.
WLAN
The optional IEEE 802.11a/b/g WLAN client radio enables wireless network communication in
the 2.4 and 5.1 GHz frequency bands.
The Compact Flash (CF) WLAN client radio connects to the CF socket in the CPU board. The two
internal dual-band antennas are attached to the front unit assembly.
WLAN connection is activated when the monitor is not connected to a wired network through
the MC port.
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BREAKER
CIRCUIT
+15Vmod +15VD
+15Va
+/-15Va
FLYBACK
MODRACK_POW_EN -15Va
BREAKER
CIRCUIT
VSYS 8.5 - 16V 5Vmod +5Vmod
BUCK
+15Vmod
5V
+5V
Linear
Regulator
I2C +15VD
I2C
I2C-BUS A/D- +15Va Over- OVERV_SD
Temp
Converter Voltage
Sensor -15Va
8-ch Protection
EMOD_ID +5Vmod
M1058830_002pivot_block_diagram.vsd
RS485 MODBUS DATA
Recorder assembly
The optional recorder assembly consists of a 50 mm recorder and a recorder board.
The recorder board interfaces the recorder to the module frame flex board. The recorder board
provides the following main functions:
• It passes the recorder control signals and the serial communication lines to the recorder.
• It has a circuit-breaker and an LC-filter for the +12 V REC supply voltage.
• It has a step-down converter that generates the +5 V REC supply voltage for the recorder
from the +12 V received from the DC/DC board.
PDM interface
The detachable PDM docking station interfaces to the module frame flex board.
The 10-pin PDM connector provides the VSYS ePort supply voltage and the Ethernet
communication lines to the PDM module.
PSM interface
The PSM connector is part of the module frame flex board.
The PSM connector provides the +15 VMod PSM supply voltage and the RS-485 communication
lines to the PSM module.
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Corrective maintenance
Service personnel shall perform the following checkout procedure steps after any corrective
maintenance, before taking the monitor back into clinical use:
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10.3.2 Display
Follow the procedure in section 8.3.2. Display.
NOTE: For some parameter modules, the table does not show the actual module information,
but the information of the individual subassemblies inside the module.
NOTE: You may need to refresh the Webmin screen if you have connected the module to the
patient monitor after entering the Device Information Webmin screen.
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10.3.6 Mouse
Follow the procedure in section 8.3.6. Mouse.
10.3.11 IX printers
Follow the procedure in section 8.3.11. IX printers.
10.3.13 Recorder
1. Select Monitor Setup > Printing > Devices > Setup and configure:
Printout: Waveforms
Location: Local
4. Verify that the recorder starts printing. Let the recorder print for approximately 10
seconds and verify the following things from the printout:
The header line contains the date, time and some other applicable status and
configuration information.
The grid is clear.
The waveforms labels appear in the printout as configured.
Select one of the following options to stop printing:
Select Stop Printing from the main screen.
Select Monitor Setup > Printing > Waveforms > Stop Printing.
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Required Tools
E-PSMP module
A multiparameter patient simulator with invasive pressure adapter cable to GE invasive
pressure connector.
5 lead ECG trunk cable, IEC or AHA
5 leadwire set, IEC or AHA
Oscilloscope
Analog output cable (2000633-001)
NOTE: You can alternatively use the GE defib sync tester, 2040582-001, together with the
Analog output cable, 2000633-001 and a multiparameter simulator to perform this test. Follow
the instructions included with the tester. See analog output cable wire colors and related
signals from the table below.
Connecting cables
1. Ensure that the module is connected to the patient monitor.
2. Connect the 5-lead ECG trunk cable to the green ECG connector in the module.
3. Connect the 5-leadwire sets to the trunk cable and to the simulator.
4. Connect the invasive pressure adapter cable to the simulator and the other end to the
module.
5. Connect the analog output cable to the defibrillation synchronization connector in the
patient monitor.
6. Connect the open wires of the other end of the analog output cable to the oscilloscope
probe as described in each test. Use the figure and table below as a reference for making
the connections.
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c. Verify that the ECG analog output waveform shown on the oscilloscope screen
corresponds to the ECG1 waveform on the monitor screen.
g. Verify that the Arterial BP output waveform shown on the oscilloscope screen
corresponds to the P1 waveform on the monitor screen.
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c. Verify that the signal shown on the oscilloscope screen corresponds to the picture above.
b. Verify that the signal shown on oscilloscope screen corresponds to the picture above
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The battery is now conditioned and ready for use. If the problem persists, replace the battery.
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11 Troubleshooting
The problems and solutions in this section represent only a few of the faults that you may
encounter and are not intended to cover every possible problem that may occur.
This chapter focuses on troubleshooting technical problems. See the patient monitor’s user’s
manual for troubleshooting monitoring problems and clinical configuration issues.
If the problem remains, call technical support for service. To ensure accurate problem solving,
please be prepared to provide the following information:
• Problem description and the troubleshooting done so far.
• Configuration information (section “11.2.1”)
• Device information (section “11.2.2”)
• Service Logs (section “11.3.4”)
• Error messages displayed, if any.
• Other information, as requested.
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Configuration information
ADT settings • Visit Number Query status, IX IP address of ADT server
Power Line Frequency • Current power line frequency setting in use.
MUSE/12SL • Location ID, Site number, MUSE web username, and
MUSE web URL.
WLAN • Wireless LAN configuration information, including WLAN
radio status, Antenna Diversity, Frequency Band, RTS
Threshold, Fragmentation Threshold, Applied QoS
Standard, WMM AC Parameters (for Voice, Video, Best
Effort, and Background), DSCP Settings (for Realtime
Clinical Traffic, Non-Realtime Clinical Traffic, and Non-
Realtime Non-Clinical Traffic), SSID, Authentication
method, Confidentiality method, and Key Index.
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Device information
Acquisition Information - PDM • Active software version, Main board revision, DAS board
revision, Serial number, Asset number, MAC address, IP
address, Power frequency, ECG filter.
Acquisition Information - E- • Label, Software version, Control number, and Serial
Module number.
Installed S/5 Printers • Printer name.
Installed IX Printers • Printer name, hostname or IP address.
Printer Location Information • Printout type (Alarm Waveforms, Numeric Trends,
Reports, and Waveforms) and Printer location.
PDM License Information • PDM license option, status, and number of licenses.
UNITY ID Information • Product ID, Unity Network ID software number and
version, Date, Time, Device name and software version of
each device connected.
USB Port Information • Product name, Manufacturer, Vendor code, Product ID,
and Serial number.
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The Hardware Statistics module displays several internal voltages, temperatures and power
consumption. A value is displayed in red, if the current reading exceeds a pre-determined lower
or upper limit, A value is displayed either as “0” or as “--”, if it cannot be measured.
To access hardware statistics:
1. Log in to Webmin.
2. Select Diagnostics > Hardware Stats.
3. Scroll down the page to view the following device information:
The controlled parameters are measured with A/D converters and temperature sensors in the
specified subsystem. The measured values are then communicated over the I2C bus to the
power management controller in the DC/DC board for processing, except for CPU voltages,
which are both measured and processed by the CPU board.
Measurement Description
+ 1.5V CPU Core Voltage (in mV) These CPU core voltages are generated on the CPU
+ 1.8V CPU Core Voltage (in mV) board from the +3.3 V supplied by the DC/DC board.
+ 2.5V CPU Core Voltage (in mV)
+ 12 Vsync CPU Voltage (in mV) These voltages are generated for the ECG and Invasive
- 12 Vsync CPU Voltage (in mV) pressure analog outputs and marker-out
synchronization pulse. The voltages are measured from
the CPU board.
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Measurement Description
AC/DC voltage (mV) The AC/DC voltage is generated by the AC/DC power
supply unit and supplied as an input voltage to the DC/
DC board. The voltage is measured from the DC/DC
board. The AC/DC voltage is “0”, if the patient monitor is
not connected to the AC mains.
Also see section 11.4. Power management LEDs.
VSYS voltage (mV) These voltages are generated by the DC/DC board and
+15V MOD voltage (mV) they are routed via the CPU board to supply power to
+12V voltage (mV) other internal subsystems. The + 12 V is also supplied
+5V voltage (mV) directly to the backlight LED adapter boardLED backlight
+3.3V voltage (mV) of the LCD display. The +15VMOD voltage is “0”, if E-
module interface board is not installed. VSYS, +12V, +5V
and +3.3V voltages are measured from the DC/DC
board. +15VMOD is measured from the E-module
interface board.
Also see section 11.4. Power management LEDs.
+5V REC voltage (mV) The +5 V REC and +12 V REC voltages are supplied for
+12V REC voltage (mV) the optional thermal recorder. The +5 V REC supply
voltage is generated in the recorder board by a step-
down converter from the + 12 V received from the DC/
DC board. The + 5 V REC and +12 V REC are measured
from the module frame flex board. These voltages are “-
-”, if recorder is not installed.
+15V MOD PSM voltage (mV) The +15 V MOD PSM voltage is supplied for the PSM
module. The voltage is measured from the module
frame flex board.
VSYS ePort voltage (mV) VSYS voltage is measured from the following locations:·
VSYS RACK voltage (mV) • The VSYS ePort voltage is supplied for a PDM module that is
VSYS EMOD (mV) connected to the PDM docking station. It is measured from
VSYS OPTION voltage (mV) the module frame flex board after the VSYS ePort circuit
breaker. The value is shown as “--” if PDM module is not
connected, or if VSYS OPTION voltage is enabled.
• The VSYS RACK voltage is measured from the module
frame flex board before the VSYS ePort circuit breaker.
• The VSYS EMOD voltage is measured from the E-module
interface board before the VSYS EMOD circuit breaker. The
VSYS EMOD voltage is shown as “--”, if the E-module
interface board is not installed.
• The VSYS OPTION voltage is supplied for a PDM module
that is connected to the ePort (DB9) interface in the
advanced interface board. It is measured from the
advanced interface board after the circuit breaker. The
value is shown as “--” if PDM module is not connected, or if
VSYS ePort voltage is enabled.
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Measurement Description
System power (mW) Power consumption is measured from the DC/DC board:
Module power (mW) • System power is the total power consumption of the
patient monitor taken from the AC/DC output or Battery.
The battery charging power is included in system power by
PMC CPU calculation.
• Module power describes the total power consumption of
the connected acquisition modules.
CPU temperature (°C) Temperature is measured from the:
DC/DC temperature (°C) • CPU board
EMOD temperature (°C) • DC/DC board
OPTION temperature (°C) • E-Module interface board
• Advanced interface board
The EMOD and OPTION temperatures are “0”, if the related
board is not installed.
Log Contents
WLAN Driver • Driver API Version
• Driver Version
• Firmware Version
• MAC Address
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Log Contents
WLAN Status • WLAN radio
• WLAN client IP Address
• Antenna diversity mode
• Center frequency (i.e., the current actual center frequency, which is
associated with the operating channel number used, e.g in the 2.4
GHz band on channel 6, the displayed frequency should be 2.437
GHz.)
• RTS Threshold
• Fragmentation Threshold
• Quality of Service:
- Applied QoS standard (i.e., None or WMM)
- QoS parameters (CWmin, CWmax, AIFS and TXOP) for each QoS
access category (Voice, Video, Best Effort, Background)
• The DSCP settings for network traffic types (Realtime Clinical Traffic,
Non-Realtime Clinical Traffic, Non-Realtime Non-Clinical Traffic)
• SSID (i.e., Service Set Identifier / network name)
• Security status:
- Authentication method (i.e., open)
- Confidentiality method (i.e., None, WEP-64, WEP-128, WPA-PSK
(TKIP), WPA2-PSK (AES-CCMP))
- Used Key Index (if WEP-64 or WEP-128 is used)
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Log Contents
WLAN status • The current Association/Authentication status of the WLAN Radio:
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Log Contents
Detected access The following information on maximum 8 detected Access Points on
points the same network (same SSID) is displayed:
• Signal Level (RSSI) in terms of dBm. Signal Level (RSSI) in terms of
dBm. The minimum RSSI should be -75dBmor greater to maintain
application performance.
• Operating channel number
• MAC Address
NOTE: If the patient monitor has associated with an Access Point,
information on only the corresponding Access Point will be displayed.
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DC/DC board
ACDC +5 V
+12 V +3.3 V
+15 VMOD
On/standby
Power management
LEDs
LED Description
On/standby (red) The red on/standby LED should be lit momentarily when the on/standby
button is pressed. A lit LED normally indicates that the DC/DC power
supply board recognizes that the user has pressed the on/standby
button and should turn the patient monitor On/Off.
If the On/standby LED is not lit when the on/standby button is pressed,
check the patient monitor for any of the following problems:
• Faulty user interface board.
• User interface cable is not connected to CPU board.
• Faulty DC/DC board.
• Faulty CPU board.
ACDC (green) The green ACDC LED should be lit when the patient monitor is
connected to the AC mains, even if the patient monitor is in standby
mode. A lit LED indicates that the DC/DC board receives the 15.3-16
VDC from the AC/DC power supply unit.
If the ACDC LED is not lit when the patient monitor is connected to live
AC mains, check the patient monitor for one of the problems:
• Main fuses are blown.
• DC/DC cable is disconnected from DC/DC board.
• Faulty AC/DC power supply unit (especially, if the patient monitor operates
normally when it is battery powered).
• Faulty DC/DC board (especially if the patient monitor does not operate
neither on AC mains nor battery power).
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LED Description
+ 12 V (yellow) These secondary voltages are created by the DC/DC board and they
should be lit when the patient monitor is turned On and operates
+ 15 VMOD (green)
normally.
+ 5 V (green) If one of the secondary voltages is not present (LED not lit) when the
+ 3.3 V (yellow) patient monitor is turned on with the on/standby button, the DC/DC
board is most likely faulty.
MC MCID NA IX
Link Activity A green, dual
LED LED purpose LED
(green) (green) (link & activity)
for each network
connector
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Field Description
Cycle count The total count of charging and discharging
cycles of the battery.
Voltage (V) Battery voltage.
Current (mA) Battery current. Positive when charging,
negative when discharging.
Temperature (°C or °F) Battery temperature.
NOTE: Refer to the Module Frames and Modules Service Manual for information about PDM
battery.
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Unable to turn on the patient The display cable is Check that the display cable is intact and properly
monitor: damaged or loose. connected to the LCD display and the CPU board.
- The patient monitor The LCD display is faulty. Replace the LCD display unit.
starts, but the primary
display remains “white”, The display controller Replace the CPU board.
i.e., the backlight section of the CPU board is
illuminates the LCD faulty.
display, but nothing
appears on the screen.
No error messages.
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Touchscreen
Problem Possible cause Recommended actions
Touchscreen operation Touchscreen not calibrated. Calibrate touchscreen, see section “7.1.2”.
inaccurate.
Touchscreen inoperative. Touchscreen cable loose Connect touchscreen cable to the user
interface board.
Faulty touchscreen sensor. Replace the front unit assembly.
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Trim Knob (only) is inoperative. Trim Knob cable loose. Connect Trim Knob encoder cable to the
user interface board.
Trim Knob encoder faulty. Replace the Trim Knob encoder.
The power indicator LEDs are User interface board is faulty. Replace the front unit assembly.
inoperative.
Alarm light does not illuminate Alarm light cable is loose Connect the alarm light cable to the user
when there is an alarm interface board.
condition on (audible alarms
Alarm light board or alarm light Replace the front unit assembly.
work and alarm message is
cable is faulty.
visible)
Alarm light does not illuminate “Warm start” It is less than 15 minutes since the last
during power-on self test. power-up (warm start) and this normal
operation.
The alarm light illuminates during the
power-on self test only if it is a cold start
(more than 15 minutes from the previous
start-up).
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E-module issues
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Check PDM Log for possible PDM errors messages, see section “11.3.4”.
If the cause is none of the above, the problem is most likely in the CPU
board. Replace the CPU board.
Flow
• Upstream broadcast: The patient monitor sends broadcasts to other network devices.
• Downstream broadcast: The patient monitor receives broadcasts from other network
devices.
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Bedside monitor doesn’t The problem is related to the • Proceed to the iCentral
register to the Monitor Network iCentral, or to the cabling troubleshooting.
- all bedside monitors affected. between the iCentral and the • Check the cabling between
hub/switch. the iCentral and the hub/
switch.
Bedside monitor doesn’t The problem is related to the • Check the patient monitor(s)’
register to the Monitor Network bedside monitor, or to the network configuration.
– only one patient monitor or cabling between the bedside • Check the cabling between
some of the bedside monitors monitor and the hub/switch. the bedside monitors and the
affected. hub.
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No wireless connection - the Patient monitor is out of wireless • Contact the hospital IT
patient monitor does not coverage area. department to check the
associate/authenticate with the wireless coverage area.
Access Point, see section WLAN radio is disabled. • Enable WLAN radio, see
“11.3.3” for WLAN diagnostics. section “7.2.4”.
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• GE recommends using the new fasteners (screws, washers, etc.) in the FRU kits rather
than reusing the old fasteners. Some fasteners are not intended to be re-used more than
three times.
• Use only new screws when attaching parts into light metal parts. Before fastening a
screw, turn it counterclockwise until it drops into an existing thread pattern.
• The maximum torque values for use with each screw and nut in reassembly are shown in
brackets in the end of each disassembly step.
• When attaching self-tapping screws to light metal parts without existing threads (new
light metal FRU parts), you should use a higher torque than is recommended for
reassembled parts, but still not more than 1.6 Nm.
WARNING Due to possible high voltage present, use an insulated screwdriver at all
times.
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3. Remove the battery. Unlock the battery cover by turning the battery cover lock 90°
clockwise and pull the battery out.
4. Disconnect all external cables connected to the monitor.
5. Detach all parameter modules from the Module Frame.
6. Detach the monitor from the mount if installed.
When re-installing the battery, make sure that the charge level indicator LEDs are facing
upwards and push the battery in all the way. Close the battery cover lock by turning it 90°
counter-clockwise.
Disassembly workflow
Use this workflow diagram to find the simplest way to disassemble the required parts of the
monitor. Numbers in the diagram refer to the sections in this chapter.
Follow the arrows from the top down to the required part and disassemble the monitor by
following the steps in between.
12.2.4 12.4.1
Module frame cover unit Rear unit Front main unit Front unit assembly
B650-02_disassembly_steps_24.vsd
E-module uDOM DC/DC CPU LCD display Trim Knob
interface board board battery unit encoder
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When reassembling, the recorder unit can be installed into the Module Frame as a whole.
NOTE: Ensure that the recorder unit is firmly installed to the recorder connector and both snaps in the EMC
cover lock properly.
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12.3.5 Disassembling the main unit into Rear and Front units
Disassemble first:
a. 12.3.2. Detaching the Interface Board
b. 12.3.3. Detaching the Frame Side Housing Decorations
c. 12.3.4. Detaching the Top Cover
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7. Pull the Front Unit away from the rear unit just
enough so that you can detach the DC/DC
cable from the DC/DC Board.
NOTE: When reassembling, check that the cable
is connected properly.
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uDOM replacement:
Contact GE Service if you doubt that the uDOM is defective and needs to be replaced. Some of the
configuration steps required after uDOM replacement can be performed only by GE service.
Provide the following information:
a) Monitor Type
b) Serial Number
c) Software version installed, if available.
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Backlight
cable
CPU
connector
DC/DC board
Battery
cable
When reassembling:
- Assemble the CPU Board first if detached.
- Connect the Battery cable.
- Slide the DC/DC board to connect the CPU connector.
- NOTE: Do not bend the DC/DC board when reassembling.
- Connect the Backlight Inverter cable and the three T10 screws. [Torque 0.8 Nm].
Reassemble the Rear Unit and the Front Unit in reverse order.
NOTE: After replacing the DC/DC Board, during the first start-up, the patient monitor will automatically check
the UIC software version in the replaced DC/DC board and update the software if necessary. Wait for 5
minutes to see if the software update is initiated and do not interrupt the process.
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NOTE: Center align the user interface cable carefully to the connector in the CPU Board and/or User Interface
Board.
Note the alignment pins to set the CPU Board in the right place.
NOTE: After replacing the CPU Board, during the first start-up, the patient monitor will automatically check the
EMBC software version in the replaced CPU Board and update the software if necessary. Wait for 5 minutes to
see if the software update is initiated and do not interrupt the process.
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DCDC
CPU
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DC/DC
CPU Board
Board
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Service parts
13 Service parts
NOTE: Perform the checkout procedure steps described in chapter 10. Maintenance and
checkout after you have replaced any service parts.
4 M1133994 FRU, Module Frame Cover Unit Set, B650 - Includes 4 different module frame front covers,
module frame cover unit and module frame
back plate with its mounting screw
5 M1133995 FRU, Module Frame Assembly, B650 - Includes module frame assembly with module
frame flex board and grounding plate
6 2077328-001 FRU, Standard Interface Board, B650 - Includes standard interface board (2 USB, 1 RJ-
VER02 45 & 1 DVI-I), related cover plate with labeling
and 6 mounting screws
7 2077329-001 FRU, Advanced Interface Board, B650 - Includes advanced interface board (4 USB, 4
VER02 RJ-45, DVI-I, ePort & Remote On) , related cover
plate with labeling and 6 mounting screws
8 2104122-001 FRU, AC/DC Power Supply Unit, B650 - AC/DC power supply without mounting plate,
VER02 SQC the DC/DC cable and 4 mounting screws
9 2104124-001 FRU, AC/DC Mounting Plate, B650 VER02 - Mounting plate for AC/DC power supply and 8
mounting screws
10 M1168221 FRU, Mains Fuses (10 pcs), B650 - FUSE, 4A, T, 250V, 5x20mm, high breaking
capacity 1500A, IEC, UL/CSA, CCC
11 2104123-001 FRU, Rear Unit Assembly, B650 VER02 - Complete rear unit assembly with handle unit
SQC and module frame mounting wall, hinges and
release mechanism. Includes also AC inlet with
fuses and wiring to AC/DC power supply unit,
equipotential connector, cable clamp for power
cord and mounting screws.
- Excludes the plastic part that has device plate
and other labeling
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17 M1168232 FRU, DC/DC Board for Models w/o - Includes DC/DC board for non-battery models
Battery, B650 with mounting screws. No cables.
18 2073134-001 FRU, CPU Board w/o uDOM, B650 VER02 - Includes CPU timekeeper battery (CR-1632) and
9 mounting screws.
- Excludes the USB Disk on Module (uDOM) with
software and all cables.
19 M1168350 FRU, CPU Timekeeper Battery (5 pcs), - CR-1632 lithium battery
B650
20 M1168312 FRU, Base Unit for Battery Model, B650 - Includes base unit for battery model, battery
door, battery board, battery cable, speaker
unit, sync board unit and GCX mounting plate
21 M1168336 FRU, Base Unit for Models w/o Battery, - Includes base unit for non-battery model,
B650 speaker unit, sync board unit and GCX
mounting plate
22 2073135-001 FRU, Mid-Frame Assembly, B650 VER02 - The mid-frame assembly includes the 4
mounting brackets for the LCD display and the
7 mounting screws and insulator plates to
mount it to the bottom unit
23 M1168356 FRU, Battery, B650 Model: Flex-3S3P rechargeable lithium-ion battery
220
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Service parts
221
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222
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Installation check form
Prior to testing verify all equipment is calibrated via “Cal” labeling and record Cal Due Dates
PASS = Test passed N.A. = Test not applicable FAIL = Test failed
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Yes: Yes: you do not have to perform the electrical safety tests. To continue the
installation check, mark the electrical safety test completion N.A. and proceed
to Functional check. If available, attach the original electrical safety test
results to this check form.
No: No: continue to perform the electrical safety tests.
Power outlet is correctly wired.
Power cord and plug are undamaged and all conductors are properly connected.
Ground integrity check Observed result Acceptance
PASS N.A. FAIL
criteria
a.) Ground continuity test without power cord 0.1 ohms
Polarity: Reversed 1 mA
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Installation check form
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Notes
Signature Date
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Maintenance check form
Prior to testing verify all equipment is calibrated via “Cal” labeling and record Cal Due Dates
Measuring equipment / test gases used:
Equipment / tool / gas: Manufacturer: Model/Type/Part No: Serial Number/ID: Cal Due Date:
PASS = Test passed N.A. = Test not applicable FAIL = Test failed
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Polarity: Reversed 1 mA
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Maintenance check form
Notes
Signature Date
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Verification procedure for wireless MC Network infrastructure
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Test plan
Each wireless installation is unique. As it is often impractical and uneconomical to verify the
whole wireless coverage area and all the installed access points, prepare a site specific test
plan that covers the areas that are most likely to encounter issues with the wireless
communication.
Utilize the information provided in the pre-quote questionnaire, existing design documentation
and site survey results, and discuss with the hospital IT specialists and clinical staff to identify
the areas that are the riskiest for poor wireless communication, and prepare a test plan
accordingly.
Take into account the following aspects when preparing a test plan.
• Identify areas with known or obvious low signal strength.
• Identify areas with known sources of radio frequency interference, causing high noise
floor and/or poor signal-to-noise ratio.
• Identify the special characteristics in the building layout (floors, wings patient rooms) and
construction material used.
• Identify the time and areas of congestion, with high number of wireless clients and a lot of
network traffic.
• Identify intended clinical workflow paths, including bedside locations and transport
routes.
Prepare the test plan by documenting the intended walking path and test points to the floor
plan, preferably to copy of a site survey document that shows the wireless coverage area, the
location of wireless access points, signal strengths and sources of known radio frequency
interferences.
NOTE: In the sample floor plan below, EG1- EG20 represent possible test points. Take into
account in your plan that some rooms and areas may not be accessible at the time of
performing the survey.
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Verification procedure for wireless MC Network infrastructure
Test setup
The patient monitors and the CARESCAPE Central Station shall be installed, configured and
tested to operate in the same MC Network.
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NOTE: The WLAN information shown in Webmin Diagnostics page is static. Press F5 to refresh
the web browser and to see up-to-date WLAN diagnostics data.
Test execution
Execute the test procedure according to the test plan. Contact the nursing staff to ensure
access to the needed areas before starting the test.
1. Move the roll cart to the starting point of the planned test route.
2. Stop at each test point and perform the following tasks:
a. On the transport monitor:
• Verify that ECG waveforms from the remote, stationary patient monitor display in
the bed-to-bed view without any losses.
b. On the service PC: Refresh Webmin view by selecting F5 and:
• Identify the Access Point the patient monitor is connected to.
• Verify that the Signal level (RSSI) in dBm is greater than or equal to -60 dBm.
• Verify that the Transmit Rate in Mbps is greater than or equal to 5.5 Mbps.
c. Mark the network time, RSSI and Transmit Rate to the test form.
d. If there is a waveform loss situation or the RSSI or the Transmit Rate is lower than
specified:
• Observe the length of the waveform loss and, if possible, potential cause of it, for
example roaming or out of range situations.
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Verification procedure for wireless MC Network infrastructure
• Take a snapshot of the refreshed WLAN Diagnostics screen, for example, by printing
it to a file.
3. Move the roll cart to the following test point along the walking path and repeat the step 2
at each test point until you have completed the test plan. While moving the roll cart from
one test point to another, at all times, verify that there are no losses in the ECG
waveforms.
NOTE: A momentary, up to 5 seconds waveform loss is normal during roaming. If longer,
or repeating waveform losses occur between test points, make this an extra test point
and report it the same way as observations in step 2.
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Test Form
Observations
Test point # Time (hh:mm:ss) RSSI (dBm) Transmit rate (Mbps) Observations
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GE Healthcare Finland Oy
Kuortaneenkatu 2
FI-00510 Helsinki
FINLAND
Tel: +358 10 39411
www.gehealthcare.com
www.gehealthcare.com