Addendum IntelliVue Instructions for Use , Service and Configuration Guide Rel G & H Jan 2003.pdf
Addendum to Instructions for Use, Service Guide
and Configuration Guide
This addendum provides information for the following situations:
you have purchased a product with a software release that is not the current release
you have downgraded a new product to a software release that is not the current release
you have upgraded a product to a software release that is not the current release
The current software release is Release J.
This addendum provides you with information relating to new findings concerning the mitigation of
safety risks. This information was not included in the Instructions for Use (IfU) for the release you
have purchased. Keep this addendum with your product documentation.
The information is arranged in sections that each cover the differences between two major releases.
Refer to the table below to see which sections are relevant for you.
If your new release is:
From section 1 to the end of the document.
From section 2 to the end of the document.
1. Between Release G and Release H
IntelliVue Patient Monitors
IfU Topic - Preparing to Measure Sidestream CO2
Make sure that you do not accidentally connect the luer connector of the gas sample line to an infusion
link or any other links in the patient vicinity.
IfU Topic - Other Patient Alarms
Changes in the alarm status of beds in a Care Group are announced visually and audibly at all other
beds in the same Care Group. The visual and audible indicators used depend on the monitor and
Information Center configuration.
Part Number 453564410081
Published in Germany 01/13
When an alarm is detected at another bed in the Care Group,
the alarm status is shown in the Alarm Status overview bar as an icon.
a message informing you about the other patient alarm is shown in the monitor status line.
if configured, the Other Bed window, the Alarming Beds window or the My Patients window may
pop up on the Screen (if automatic alarm notification is enabled at the bedside monitor and at the
Information Center). The automatic alarm notification is suppressed when a window, menu or
pop-up keys are active.
if configured, an audible status change notification is issued. The tone type and volume can be
IfU Topic - Assigning a Telemetry Transceiver with an SRR Adapter to a Monitor
Short range radio connections are subject to interruption due to interference from other radio sources
in the vicinity, including microwaves, bluetooth devices and DECT phones. Outside the operating
frequency band and 5% above and below, i.e. the exclusion band according IEC 60601-1-2, section
36.202.3a)4), the short range radio connection is immune up to 3V/m in the frequency range from
80 MHz to 2.0 GHz and up to 1V/m in the frequency range from 2.0 to 2.3 GHz. Depending on the
strength and duration of the interference, the interruption may occur for an extended period. A loss of
connection, due to moving out-of-range, interference, or for other reasons, is indicated with a Tele
Service Guide Topic - Assembling Mounts
Perform the Mounting Integrity Test:
– whenever you have removed and reassembled a quick mount
– if one or both of the quick mount screws are loose
– if there is a clearance between the quick mount and the monitor bottom housing
– if the monitor mounting is unstable
see "Mounting Integrity Test" for details.
IfU Topic - Electromagnetic Emissions
The monitor should not be used next to or stacked with other equipment. If you must stack the
monitor, you must check that normal operation is possible in the necessary configuration before you
start monitoring patients.
IfU Topic - Replacing a Battery
Do not insert your fingers or any objects into the open battery compartment.
IfU Topic - Monitoring with Measurement Extensions
Measurements from an MMS extension connected to an X2 are not available when the X2 is running
on its own battery power. They are only available when the X2 is powered by external power: when
connected to a host monitor, to the external power supply (M8023A) or to the Battery Extension
IfU Topic - Viewing Histogram Trends
A question mark is displayed if less than two-thirds of the data are valid samples.
IfU Topic - Monitoring SpO2
Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it
is too tight, for example because the application site is too large or becomes too large due to edema,
excessive pressure may be applied. This can result in venous congestion distal from the application site,
leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may
occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and
lacerations, periodically inspect the sensor application site and change the application site regularly.
IntelliVue Cableless Measurements
IfU Topic - Assigning an IntelliVue Cableless Measurement Device to a Patient
Monitor or Telemetry device
Short Range Radio connections are subject to interruption due to interference from other radio
sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and
cordless phones. Depending on the strength and duration of the interference, the interruption may
occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for
other reasons, is indicated with a No Host Monitoring INOP on the SpO2 Pod, or a cl SpO₂
Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the
Configuration Guide for details.
IfU Topic - R&TTE Directive Compliance
The device, equipped with a wireless network interface, intentionally receives RF electromagnetic
energy for the purpose of its operation. Therefore, other equipment may cause interference, even if
that other equipment complies with CISPR emission requirements.
2. Between Release H and Release J
IfU Topic - Repositioning a Monitor on the Mounting Arm
Additional information and warning:
Attempts to reposition the monitor should only be performed as described in the mounting hardware
manufacturer’s user documentation. If the mounting arm has a locking mechanism, ensure the locking
mechanism is unlocked before attempting to reposition the monitor. Never pull on the monitor to tilt,
swivel or otherwise reposition it - always hold on to the mounting hardware itself.
Not adhering to these instructions when repositioning the monitor can cause damage to the monitor.
In extreme cases, when force is applied to the monitor, it can result in the monitor falling from the
If, at any time, the monitor appears to be loose or insecurely mounted, contact your service personnel.
IfU Topic - Inspecting the Monitor
If the monitor or mounting hardware is mechanically damaged, or if it is not working properly, do not
use it for any monitoring procedure on a patient. Contact your service personnel.
Service Guide Topic - Mounting Instructions
Incorrect mounting and use of inappropriate mounting material may lead to injury. It is the customer’s
responsibility to ensure that the mounting procedures have been performed correctly and the
appropriate mounting devices have been used.
IfU Topic - Smart Alarm Delays
Before using Smart Alarm Delays, make sure that you fully understand how the delay is applied and
what the consequences are.
Configuration Guide Topic - SmartAlarmDelay
Only people authorized by their institution to activate SpO2 SmartAlarmDelay shall make changes
in configuration mode. They require the configuration mode password.
IfU Topic - Setting Smart Alarm Delay Mode
If you also use monitors with earlier software revisions, be aware that smart alarm delays will not be
used after a transfer to one of these monitors. Monitors with earlier software revisions will always use
the standard alarm delay. If you are not sure whether a monitor has the Smart Alarm Delay function,
check whether there is a SmartAlarmDelay entry in the Setup SpO₂ menu.
Configuration Guide Topics - Hide Keys and Hide Alarm Info
only apply to monitors with two or three main displays.
are only available for Display 2 and Display 3.
have no effect on the XDS Remote Display. The monitor will behave as if the settings were set to
G1/G5 Gas Analyzers
Service Guide Topic - Post Installation Checks
After installation, always check that the connections to the gas analyzer are correct. The RS232
connector is to be used only for connecting the gas analyzer to the patient monitor.
IfU Topic - Gas Analyzer Accessories
All accessories listed below may be used with the M1013A IntelliVue G1 and the
M1019A IntelliVue G5.
Pieces per Pack
Elbow Airway Adapter
single patient use
Straight Airway Adapter 20
single patient use
Gas Exhaust Return
Gas Exhaust Return
single patient use
multi-patient use, must be
replaced every 2 weeks or
sooner if full before.
Gas Sample Tube
single patient use
Gas Exhaust Tubing