Addendum
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Addendum for software version 1.1.10
Document no. M1241543 24 January 2012 © 2012 General Electric Company. All rights reserved. All specifications are subject to change without notice.
GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki, Finland Tel: +358 10 39411 www.gehealthcare.com
CARESCAPE Monitor B650
Addendum for software version 1.1.10 Intended use of this addendum This addendum applies to the CARESCAPE B650 Monitor starting from software version 1.1.10. This addendum must be used in conjunction with the “CARESCAPE Monitor B650 User's Manual” for important safety information and detailed instructions for clinical use of this product, with the “CARESCAPE Monitor B650 Supplemental Information Manual” for a list of compatible devices and a list of factory default settings, and with the “CARESCAPE Monitor B650 Supplies and Accessories” document for a complete list of available supplies and accessories.
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Changes regarding the “CARESCAPE Monitor B650 Supplemental Information Manual”
Changes regarding the “CARESCAPE Monitor B650 Supplemental Information Manual” Parameter measurement modules compatibility PDM compatibility Note the following change: The monitor is compatible with PDM v1.3, v1.4 and v2.1 (Masimo and Nellcor).
Other E-module and M-module compatibility Note the following change:
•
E-BIS..00, E-BIS-01; M-BIS..00
Input-output device compatibility Input devices Note the following change: 2039040-0xx USB Remote
CARESCAPE Network compatibility Central stations Note the following change:
•
CARESCAPE CIC Pro Clinical Information Center v4.0.7, v4.0.8, v4.1.1-1, v5.0.8, v5.1 and v5.2.
Miscellaneous network devices Note the following addition:
•
Mobile Care Server v6.0
Unity Network ID compatibility Note the following change:
•
The monitor is compatible with the Unity Network ID v1A, v3B, v4A, v4B, v5A, v5B, v5C and v6A.
Additional information Invasive blood pressure acquisition modules Note the following change: Up to 7 channels can be active at the same time.
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Changes regarding the “CARESCAPE Monitor B650 Supplemental Information Manual”
Alarms specifications Alarm priorities and escalation times Note the following additions: MESSAGE
NOTES
LOCATION
PRIORITIES AND ESCALATION TIMES info
Alarms audio S/5 Network paused from Central
• alarm
Arrhythmia paused
ECG, Alarm Priority = Escalating
• alarm
Audio OFF from Central
S/5 Network
• alarm
low
high
0s 0 s according to priority setting: high, medium, low.
0s
• alarm
<Bed> Monitor disconnected
medium
0s
Information Center busy
S/5 Network
• alarm
0s
Information Center not responding
S/5 Network
• alarm
0s
Loading failed. Wrong patient
S/5 Network
• alarm
0s
Network: <Central name>
S/5 Network
• alarm
0s
Network down: <central name>
S/5 Network
• alarm
0s
Noisy ECG
ECG, Alarm Priority = Escalating
• alarm
Saving to network
S/5 Network
• alarm
0 s, according to priority setting: high, medium, low
0s
Default settings Configuring care unit settings Note the following changes in the default settings:
Alarm settings Setting
Description
Audio Pause: For Remote Bed
Enable Audio pause for a remote bed from this monitor.
ED
ICU
NICU
OR
PACU
Not Allowed
CARESCAPE Network only. Audio Pause: From Remote Location
Select the alarm priority levels that can be remotely paused for this monitor.
Not Allowed
CARESCAPE Network only.
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Changes regarding the “CARESCAPE Monitor B650 User's Manual”
Parameter settings Setting
Description
ED
ICU
NICU
Apnea Alarm Deactivation
Enable the Apnea alarm deactivation/activation.
Not Allowed
SpO2 Probe Off Deactiv.
Enable the SpO2 probe off alarm deactivation/ activation.
Not Allowed
OR
PACU
Configuring current patient settings Note the following changes in the default settings:
Alarm priority settings Setting
ED
ICU
NICU
Arrhythmia paused
Escalating
Noisy ECG
Escalating
SpO2 high
Escalating
SpO2 low
Escalating
OR
PACU
Parameter settings Note the following changes in the default settings:
SpO2 default settings Setting
Description
Response
Select the averaging time.
ED
ICU
NICU
OR
PACU
Fast
PDM Nellcor only.
Changes regarding the “CARESCAPE Monitor B650 User's Manual” About this device Indications for use warnings Note the following addition:
WARNING: INTRAHOSPITAL TRANSPORT - Vibrations during intrahospital transport may disturb the InvBP measurement.
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Changes regarding the “CARESCAPE Monitor B650 User's Manual”
System introduction Equipment symbols Note the following addition: Medical Equipment With respect to electric shock, fire and mechanical hazards only in accordance with IEC 60601-1, EN60601-1; UL 60601-1; CAN/CSA C22.2 NO.601.1-M90; IEC 60601-1-1.
Alarms Note the following changes:
Alarm warnings WARNING: The audible alarm signal may be paused temporarily from a central station or remote monitor. WARNING: There are no alarm indications until parameter specific alarm prerequisites have been met. Audible and visual alarm signals When physiological alarm messages are received from other monitors on the S/5 Network, only the most recent and highest priority message field alarm is shown. There are no flashing numerics or background color. No messages are shown in the parameter window area.
Selecting parameter alarm priority levels 1.
Select Alarm Setup from the monitor’s main menu.
2.
Select the Alarm Priorities tab.
3.
Select an alarm priority from Alarm Priority list. Choices are:
HR/PR
ST Segment
Frequent PVCs
Noisy ECG
Arrhythmia paused
SpO2 high
SpO2 low
Art, ABP, Fem, UAC, PA, CVP, RAP, RVP, LAP, ICP, P1-P8
TcCO2/O2
Managing alarms from a remote location The remote alarm settings are defined in the care unit alarm defaults and allow you to define the following:
Allow a Remote Audio Pause for this monitor from a central station or from a remote monitor.
Allow Audio Pause for a remote bed from this monitor.
Show the remote patient name.
Turn a remote monitor’s alarm light on/off.
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Changes regarding the “CARESCAPE Monitor B650 User's Manual”
Choose the remote alarm notification tone.
NOTE: When viewing a remote monitor via a bed-to-bed view on the S/5 Network, you cannot pause audio alarms. See the “CARESCAPE Monitor B650 Supplemental Information Manual” for details.
Setting up the monitor before use Selecting parameters to the screen Note the following changes: Most parameters appear on screen automatically when their measurement starts. However, if you cannot see the parameter you are measuring, select it to the screen: 1.
Select Monitor Setup > Screen Setup.
2.
Select the parameter to the upper or lower parameter area:
• •
Select Upper Parameter Area >Show Parameter. Select Lower Parameter Area and activate it by selecting the radio button On. Then select the parameter from the dropdown list.
Starting and ending monitoring Note the following changes: NOTE: PDM only. When monitoring is started, stored invasive pressure labels for those channels that have cables connected will be transferred from the PDM to the monitor. The labels for any disconnected channels will be transferred when those cables are connected. Note that the currently stored labels may differ from defaults. Exceptions:
•
If a cable is disconnected from the PDM and then reconnected, the label is not transferred; the label currently selected in the monitor will be used instead.
•
Continue menu: If you select Continue Current, Erase PDM Data or Discharge, the PDM current labels are set to defaults (P1:Art, P2:PA, P3:CVP, P4:LAP), and will be transferred to the monitor for those channels that have their cables connected.
NOTE: All labels have their specific alarm limit settings on the monitor.
Loading patient data and trend data from the S/5 Network 1.
Select the patient data field.
2.
Select the Load Patient tab.
3.
Select a network from the Central list. A patient table appears, showing all the patients connected to the chosen network. NOTE: Loading and merging are only possible from an iCentral connected to the monitor (not from an external iCentral).
4. 5.
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Select a patient from the table. One of the following selections is available:
Start New when there is no active patient case/admitted patient on the monitor. Select this to load patient data from the network.
Reset Current or Discharge Current when there is an active case/admitted patient on the monitor. Select this to end the case/discharge the patient. The Start New selection will then appear.
Changes regarding the “CARESCAPE Monitor B650 User's Manual”
Merge to Current when there is an active patient case/admitted patient on the monitor and the same patient can be found at the central station. Select this to merge their patient data. The message Loading from network is displayed until all data has been loaded.
The monitor will send all updated patient data except trends to the connected acquisition modules.
Viewing other monitored patients Note the following changes: See the “CARESCAPE Monitor B650 Supplemental Information Manual” to configure the following remote alarm configuration settings:
Alarm priority for an allowed Audio Pause: From Remote Location. Choices are: Not Allowed; Low; Medium, Low; and High, Med, Low. NOTE: CARESCAPE Network MC only.
Enable or disable pausing the audio remotely for another monitor (Audio Pause: For Remote Bed). Choices are Allowed and Not Allowed. NOTE: CARESCAPE Network MC only.
Pausing remote patient bed audible alarms NOTE: The monitors must be on the CARESCAPE Network. The remote monitor must be configured to allow Audio Pause: From Remote Location to occur. To pause the active alarms for the remote bed viewed from the bed-to-bed window, select Remote Audio Pause. If the selection is not available, this option has not been enabled during configuration.
Trends and snapshots Note the following addition:
Gas consumption view NOTE: Only available through the Unity Network Interface Device (ID) v6 or later. The Gas consumption view shows the amount of Air, O2, N2O, and anesthetic agents used by an interfaced anesthesia machine during the ongoing patient case. 1.
Select Trends.
2.
Select Machine Gas Cons. from the View list.
3.
You can print the currently viewed page by selecting Print Page.
NOTE: You must print the report before discharging the patient/ending the case. NOTE: If the values for Air, O2, or N2O exceed the range limit, the text >32767 appears instead of the value. For the anesthetic agents, the text is >999.
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Changes regarding the “CARESCAPE Monitor B650 User's Manual”
System messages Note the following changes: Message
Location
• Entropy sensor off • al. area • Sensor off • param.
Explanation
What to do
Entropy: The sensor is connected to the cable but not attached to the patient, or the sensor type is not correct.
• Check that the sensor is properly attached to the patient.
• Check that the sensor is an Entropy sensor.
• No Entropy
• al. area
sensor
• No sensor
Entropy: The sensor is not connected to the cable, or the sensor and cable are not compatible.
• Check connection between Entropy sensor and cable.
• Check that the cable and sensor are compatible.
Note the following additions: Message
Location
Explanation
What to do
Alarms audio paused from Central
• al. area
The alarms were remotely paused from the iCentral.
• You can activate the alarms by
Audio OFF from Central
• al. area
The alarms have been turned off from the iCentral.
• You can change the selection
<Bed> Monitor disconnected
• al. area
Monitor with Alarm Notification enabled is disconnected from the network.
• Re-establish the connection.
Information Center busy
• al. area
S/5 Network has too many bed-tobed connections.
• Try again later.
Information Center not responding
• al. area
S/5 Network is busy and the central is not responding.
• Try again later.
Loading failed. Wrong patient
• al. area
Merging a case from the S/5 • Check that the Last Name, First Network was refused by the central. Name and Medical Record Number are identical on the monitor and central, or that the monitor has no information in these fields.
Network:<Central name>
• al. area
Connection to an iCentral is established.
• No action required.
Network down: <central name>
• al. area
The monitor has lost connection to an iCentral in the S/5 Network.
• Check the network connections.
Saving to network
• al. area
Connection to the S/5 Network was established and the monitor is saving patient data collected while disconnected from the network.
• No action required.
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pressing the Audio Pause key. from Alarm Setup > Audible & Visual.
Changes regarding the “CARESCAPE Monitor B650 User's Manual”
ECG Note the following changes: NOTE: 12RL measurement data is not sent to the S/5 Network.
ECG warnings WARNING: - NOISY ECG alarm - The “Noisy ECG” alarm indicates that the system is no longer monitoring ECG and there may be no HR high or HR low alarms. If you adjust the alarm priority level lower than the default value, keep the patient under close surveillance. Selecting alarm priorities for Noisy ECG and Arrhythmia paused You can set the alarm priorities for Noisy ECG and Arrhythmia paused through Alarm Setup > Alarm Priorities.
Arrhythmia detection
Arrhythmia alarm messages Note the following changes: Alarm message
Arrhythmia Alarm analysis priority
Arrhythmia detection criteria
A Fib
Full: All other software packages except NICU.
According to Absence of P-waves and irregular RR interval. priority setting
Accel. Ventric.
Full
According to Accelerated ventricular rhythm - Run of PVCs with a run length of at least priority setting six beats and the rate requirements have not met for V Tach or V Brady.
Asystole
Lethal
High
Bigeminy
Full
According to Every other beat is PVC (N-V-N-V-N-V). priority setting
Brady
Lethal: NICU According to PDM: Displayed 4/8-beat average ECG heart rate falls below the usersoftware priority setting selected common HR low limit or ECG HR low limit. package only. Full: All other software packages except NICU.
Couplet
Full
According to Two consecutive PVCs are detected between normal beats, N-V-V-N. The priority setting coupling interval between the PCVs must be less than 600 ms.
Irregular
Full
According to PDM in NICU software package only: Six consecutive normal RR intervals priority setting vary by 100 ms or more.
Missing beat
Full
According to E-modules: Actual RR interval more than 1.8 times the average RR priority setting interval.
Multifocal PVCs Full
According to E-modules: Over the last 15 beats two or more PVCs with different priority setting morphologies are detected.
Pause
Full
According to Actual RR interval more than a configured value (1-5 s). priority setting
Rapid VT
Lethal
According to E-modules: A run of PVCs is detected with a run length of six beats or priority setting more. In addition an effective HR that exceeds 160 bpm.
HR decreased to zero.
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Changes regarding the “CARESCAPE Monitor B650 User's Manual”
Alarm message
Arrhythmia Alarm analysis priority
Arrhythmia detection criteria
R on T
Full
According to Isolated PVC is detected within 100 ms of the peak of the T-wave of the priority setting patient’s predominant normal beat.
Single PVC
Full
According to PDM: Isolated PVC is detected. priority setting
Tachy (Tachycardia)
Full
According to PDM: Occurs when 4 consecutive RR intervals or the displayed 4/8-beat priority setting average ECG heart rate exceeds the user-selected common HR High Limit or ECG HR High Limit.
Trigeminy
Full
According to Every third beat is a PVC (N, N, V, N, N, V, N, N, V.) priority setting
V Brady
Full
According to Run of PVCs are detected with a run length of at least three beats. In priority setting addition, at least two consecutive RR intervals in the run must have an effective heart rate less than 50 bpm.
V Fib
Lethal
High
E-modules: ECG waveform indicates a chaotic ventricular rhythm.
V Fib/ V Tach
Lethal
High
PDM: ECG waveform indicates a chaotic ventricular rhythm.
V Tach
Lethal: All According to A run of PVCs is detected with a run length of six beats or more. In other priority setting addition an effective HR that exceeds 100 bpm. software packages except NICU. Full: NICU software package only.
VT>2
Full
According to A run of PVCs is detected with a run length of more than two beats but priority setting less than six beats. In addition at least two consecutive RR intervals in the run must have an effective HR that exceeds 100 bpm.
Airway gases with E-modules Note the following changes:
Airway gases measurement setup with E-modules 1.
Make sure that the water trap container is empty and properly attached.
2.
Connect the gas sampling line to the sampling line connector on the water trap.
3.
Connect the sample gas outlet to gas scavenging if N2O or volatile agents are used.
4.
Turn on the monitor or connect the module to the monitor. The monitor performs a selfcheck for the module when the module is connected. Automatic agent identification is activated in those modules that have this feature.
5.
Wait until the message Calibrating disappears.
6.
Connect the sampling line to the airway adapter or the airway adapter to the ventilator circuit. Position the adapter with the sampling port upwards to minimize the amount of condensed water possibly entering the sampling line.
7.
Check that the airway adapter connections are tight and that the adapter is operating properly.
NOTE: Check that the sample line is connected to the water trap before connecting the module to the monitor or turning on the monitor. NOTE: To minimize the amount of dust drawn into the gas sampling system, always keep the water trap connected to the module. When the module is not in use, you can disconnect it from the monitor to eliminate the operating sound of the gas pump.
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Changes regarding the “CARESCAPE Monitor B650 User's Manual”
CO2 measurement with E-modules Activating or deactivating the Apnea alarm NOTE: This feature is meant to be used when ending CO2 monitoring. It should not be used during active CO2 monitoring. This setting can be enabled during configuration. If it has been enabled, there will be a button in the CO2 Setup window that allows you to activate or deactivate the alarm: 1.
Select the gases parameter window.
2.
Select the CO2 > Setup.
3.
Select Deactivate Apnea Alarm or Activate Apnea Alarm. The text on the button will change accordingly.
NOTE: When the alarm is deactivated, there will be no audible or visual Apnea alarm indications. The alarm is automatically reactivated if CO2 vital signs are detected and alarm condition is met again. For more information on alarm activation, see the “Alarms” chapter.
WARNING: With deactivated ‘Apnea’ alarm, keep the patient under close surveillance.
Pulse oximetry (SpO2) Note the following additions:
Selecting the response time NOTE: PDM Nellcor only. You can select the response (averaging) time. Fast (default) is the recommended setting. 1.
Select the SpO2 parameter window.
2.
Select the SpO2 or SpO2(2) tab.
3.
Select the radio button for the response time: Normal or Fast.
Activating or deactivating the SpO2 Probe Off alarm NOTE: This feature is meant to be used when ending SpO2 monitoring. It should not be used during active SpO2 monitoring. This setting can be enabled during configuration. If it has been enabled, there will be a button on the SpO2 and SpO2(2) tabs that allows you to activate or deactivate the alarm: 1.
Select the SpO2 parameter window.
2.
Select the SpO2 or SpO2(2) tab.
3.
Select Deactivate SpO2 Probe Off or Activate SpO2 Probe Off. The text on the button will change accordingly.
NOTE: When the alarm is deactivated, there will be no audible or visual SpO2 probe off alarm indications. The alarm is automatically reactivated if SpO2 vital signs are detected and alarm condition is met again. For more information on alarm activation, see the “Alarms” chapter.
WARNING: With deactivated ‘SpO2 probe off’ alarm, keep the patient under close surveillance.
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Changes regarding the “CARESCAPE Monitor B650 Supplies and Accessories” document
Printing Note the following changes:
Manual printing NOTE: Manual printing is possible only when the printing device is not processing another job at the same time. 1.
Select Trends.
2.
Select trend type from the View list: Graphic, Numeric, Event, Snapshot, ST-Snapshot, and Machine Gas Cons. Select desired Time Scale. NOTE: Time Scale is not selectable in the Numeric, Event, and Machine Gas Cons. views.
3. 4.
Select Print Page.
Changes regarding the “CARESCAPE Monitor B650 Supplies and Accessories” document SpO2 accessories Note the following additions:
TruSignal SpO2 accessories Part number
TruSignal SpO2 accessory description
Approved for use with
TS-SP3-GE
TruSignal Integrated PediTip sensor with GE connector, 3 m/10 ft, E-PRESTN, E-RESTN, E-PSM, E-PSMP 15 to 30 kg (33 to 66 lbs)
TS-SP-D
TruSignal PediTip sensor with GE connector, 1 m/3.3 ft, 15 to 30 kg (33 to 66 lbs)
E-PRESTN, E-RESTN, E-PSM, E-PSMP
TS-AP-10
TruSignal Adult/Pediatric adhesive sensor, 0.3 m/1 ft
E-PRESTN, E-RESTN, E-PSM, E-PSMP
TS-AP-25
TruSignal Adult/Pediatric adhesive sensor, 0.3 m/1 ft
E-PRESTN, E-RESTN, E-PSM, E-PSMP
Cardiac output accessories Note the following change: Part number
Cardiac output accessory description
Approved for use with
16592
Flow-through Injectate Temperature Probe, use with Edwards catheters
E-COP, E-COPSV
Entropy accessories Note the following additions: Part number
Entropy accessory description
Approved for use with
M1174413
Entropy EasyFit Sensor, pkg of 25 pcs
E-ENTROPY
Entropy EasyFit Sensor Start-up Kit, includes:
E-ENTROPY
M1174414
• Entropy EasyFit Sensor (M1174413), 2 boxes • GE Entropy Cable (M1050784), 1 pc
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Changes regarding the “CARESCAPE Monitor B650 Supplies and Accessories” document
BIS accessories Note the following additions: Part number
BIS accessory description
Approved for use with
900508
Simulator for BIS Sensor Plus
E-BIS
M1209916
BIS Pediatric Sensor
E-BIS
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Changes regarding the “CARESCAPE Monitor B650 Supplies and Accessories” document
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