Sensium Healthcare TZ202055R1 Wireless Patient Monitoring Device User Manual TZ202000 IFU

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Date Submitted	2012-06-26 00:00:00
Date Available	2012-06-26 00:00:00
Creation Date	2012-06-15 10:49:12
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Document Title	TZ202000-IFU
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Document Author:	Toumaz UK

SensiumVitals Wireless Monitoring
System
User Manual
Part Number: TZ202000-IFU
Toumaz and the
Toumaz logo are
trademarks or
registered trademarks
of Toumaz or one of its
subsidiaries.
All other trademarks are
the property of their
respective owners.
Toumaz US LLC
Los Angeles, CA
USA
www.toumaz.com
© 2012
Toumaz US LLC or one
of its subsidiaries.
All rights reserved.
SensiumVitals Wireless Monitoring System
Directions for Use
Changes in equipment, software, or procedures occur periodically;
information describing these changes will be included in future editions of the
guide.
The information in this document is subject to change and does not represent
a commitment on the part of Toumaz to provide additional services or
enhancements.
Contents
About This Guide.................................................................v
Chapter 1—General Information
Intended Use........................................................................................................... 1
Heart rate monitoring ..................................................................................... 1
Respiratory rate monitoring............................................................................ 1
Axillary temperature monitoring .................................................................... 2
Monitoring symbols ............................................................................................... 2
General warnings and cautions............................................................................... 3
Safety and compliance information ................................................................ 4
System information ................................................................................................ 4
System components ........................................................................................ 4
Patch components ........................................................................................... 5
Wireless Monitoring Application screens ...................................................... 6
Main screen .......................................................................................... 6
Patient History screen .......................................................................... 8
Chapter 2—Using the SensiumVitals Wireless Monitoring
System
Logging in and out ................................................................................................. 9
Starting patient monitoring................................................................................... 10
Required equipment...................................................................................... 10
Applying the patch ....................................................................................... 10
Adding patient to wireless monitoring ......................................................... 14
Monitoring patients .............................................................................................. 17
Editing patient settings and vital sign limits................................................. 17
Notifications ................................................................................................. 18
Receiving notifications ...................................................................... 18
Acknowledging Notifications ............................................................ 18
Reminder notifications ....................................................................... 19
Escalation notifications ...................................................................... 20
Replacing a Patch ................................................................................................. 20
Updating patch information in the Wireless Monitoring Application.......... 20
TZ202000-IFU Wireless Monitoring System Directions for Use
iii
Contents
Removing a patient from wireless monitoring ..................................................... 21
Running a Clinical Data Report ........................................................................... 22
Assigning beds to groups ..................................................................................... 23
Chapter 3—Troubleshooting
Logging in and out ............................................................................................... 25
Adding a patient ................................................................................................... 25
Monitoring a patient ............................................................................................. 26
Patient History ...................................................................................................... 29
Removing patients from Wireless Monitoring ..................................................... 29
General application questions .............................................................................. 29
Notification questions........................................................................................... 30
Error message questions ....................................................................................... 30
Appendix A—Technical Specifications
Performance specifications................................................................................... 31
Patch specifications .............................................................................................. 31
Appendix B—Compliance and Safety Info
FCC compliance statement (United States).......................................................... 33
Safety .................................................................................................................... 34
FCC Radiation Exposure Statement ............................................................. 34
Electromagnetic compatibility ............................................................................. 35
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TZ202000-IFU Wireless Monitoring System Directions for Use
About This Guide
This guide describes the Toumaz SensiumVitals Wireless Monitoring System
and provides instructions for wireless monitoring of patients.
The SensiumVitals Wireless Monitoring System is used to monitor a patient’s
vital signs, including heart rate, respiratory rate, and axillary temperature.
Symbols
This document uses the following symbols:
Warnings indicate potentially hazardous situations which, if not avoided,
could result in injury or death.
Caution indicates conditions that could damage equipment or other
property.
Notes contain supplementary information or emphasize a point or
procedure.
TZ202000-IFU Wireless Monitoring System Directions for Use
About This Guide
vi
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 1
General Information
Intended Use
The SensiumVitals Wireless Monitoring System is intended for use by health care
professionals for routine surveillance of patient physiological parameters in a
healthcare setting. Data is transmitted wirelessly to a central location. Alerts can
be set on an individual patient basis to inform healthcare professionals when
vital sign readings are measured outside of preset limits.
The device is not intended to be used in the ICU or CCU and is intended to
supplement vital signs monitoring by healthcare professionals, not to replace it.
The device is intended for use on general care patients and on patients who are
18 years of age or older.
Heart rate monitoring
•
Uses ECG to detect the heart rate (HR) only;
•
Cannot be used to detect the absence of a heart rate;
•
Provides intermittent HR readings in a range of 30–200 beats per minute
(BPM) when conditions are appropriate;
•
Cannot be used to detect any forms of arrhythmia or any other
conditions usually detected through an ECG.
Respiratory rate monitoring
•
Uses impedance pneumography to detect respiratory rate (RR);
•
Provides intermittent RR readings in a range of 5–60 breaths per minute
(BrPM);
Due to the nature of impedance pneumography, it is possible that RR
readings often appear as not available. This situation is more likely to
happen when the patient is moving.

TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 1—General Information
Axillary temperature monitoring
•
Measures the axillary temperature using a probe underneath the axilla;
•
Provides intermittent axillary temperature readings in a range of 89.6 to
111.2°F;
•
Due to the dependence on the patient’s proper arm position, it is possible
that axillary temperature sometimes appears as unavailable;
•
Cannot be used to detect rapid drops of core body temperature.
Monitoring symbols
The following symbols may appear in the Wireless Monitoring Application.
Heart Rate (in beats per minute)
Respiratory Rate (in breaths per minute)
Axillary Temperature (in degrees Fahrenheit or Celsius, depending on
your configuration)
Add Patient to Wireless Monitoring
Remove patient from Wireless Monitoring
System is processing information. Please wait.
Notification
(Blinking)
Replace Patch
Replace Patch Now
(Blinking)
Patch Out of Range
Signal Lost (patch out of range for longer than specified time)
(Blinking)
??
Invalid Data
--
Data Unavailable
TZ202000-IFU Wireless Monitoring System Directions for Use
General warnings and cautions
General warnings and cautions
General warnings
WARNING—Do not use the SensiumVitals Wireless
Monitoring system on critical care patients.
WARNING—Remove patch before defibrillating the patient.
WARNING—The system is not designed for use with
pacemakers, implantable defibrillators, or neurostimulators.
WARNING—The system is not designed for use near magnetic
resonance imaging (MRI) equipment. Patch must be removed
from any patient about to undergo an MRI.
WARNING—The patch is not designed for use on patients under
the age of 18.
WARNING—Do not apply the patch on breached or compromised
skin surfaces or on mucosal membranes.
WARNING—The patch is a single-use device. After the patch is
removed from a patient, do not reuse the patch, whether on the
same patient or on a different patient.
General Cautions
CAUTION—The patch is a radio frequency (RF) emission device
and should not be used in RF sensitive areas.
CAUTION—The system is not designed for direct X-ray
exposure. Patch must be removed from any patient about to
undergo an upper torso X-ray.
CAUTION—The system is not designed for use near X-ray
computed tomography (CT) equipment. Patch must be removed
from any patient about to undergo a CT scan.
CAUTION—The patch is designed to be shower-proof, but vital
sign readings may be temporarily unavailable during a shower
depending on the condition of the ECG electrodes used.
It is not designed to be immersed in water or any other liquid.
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 1—General Information
Safety and compliance information
This device has been designed for compliance with applicable Safety and
Electromagnetic Compatibility (IEC & FCC) regulations. See FCC compliance
statement (United States) on page 33.
System information
This section describes the system components, patch components, and the
main screens of the Wireless Monitoring Application.
System components
System components and descriptions are provided in the following graphic
and table.
System component descriptions
Item
Description
SensiumVitals Wireless
Monitoring Patch
Collects and transmits vital sign data from patients
to the system.
Bridges
Sends the vital sign data from each patch to the
Monitoring Server.
Monitoring Server
Provides a link between the bridges and the
Wireless Monitoring Application. Manages vital sign
data and notifications.
Wireless Monitoring
Application
Displays vital sign data and notifications. Caregivers
can use it to access system features.
Notification devices
Pager, PDA, or other device—used to receive
and display notifications.
TZ202000-IFU Wireless Monitoring System Directions for Use
System information
Patch components
The disposable patch, when applied to the patient and activated, collects and
transmits patient vital sign data: heart rate, respiratory rate, and axillary
temperature. The vital sign data are then displayed on the Wireless
Monitoring Application.
Electrode connectors
Attachment points
Patch ID
Activation tab
Axillary
section
Temperature
sensor
Patch component descriptions
Item
Description
Electrode connectors
Connectors on the underside of the patch
where monitoring electrodes are attached.
Patch ID
Barcode and number which uniquely identify the
patch.
Activation tab
Removing this tab activates the patch.
Temperature sensor
Used to read the patient’s axillary temperature.
Attachment points
Used to secure the temperature sensor in the
proper location.
Axillary section
The part of the temperature sensor which is
placed beneath the patient’s axilla.
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 1—General Information
Wireless Monitoring Application screens
The Wireless Monitoring Application is a web-based application accessed using
Internet Explorer on a standard hospital PC computer.
Main screen
Main screen components
Identifier Component
Description
Unit name
Displays the unit for which the data is being
displayed.
System time and date
Displays the current system time and date.
About button
Displays SensiumVitals Wireless Monitoring
System information and provides a link to
online help.
Log out button
Logs you out of the system.
Group drop-down
Add Patient button
Allows you to add a patient to
wireless monitoring.
Replace Patch button
Allows you to replace a patch on a patient
being monitored.
Remove Patient button
Allows you to remove a patient from wireless
monitoring.
Patient History button
Allows you to view patient vital sign history
and access patient settings.
Actions drop-down
Allows you to assign beds (depending on
access rights) and run a Clinical Data Report.
list
list
Allows you to display a particular group in a
unit or display all patients in the unit.
TZ202000-IFU Wireless Monitoring System Directions for Use
System information
Main screen components (continued)
Identifier Component
Description
Notification column
Displays a notification icon (see Monitoring
symbols on page 2) if there is a notification for
that patient. Click the icon to see notification
details. Click the column heading to sort the
patients with open notifications at the top of
the list.
Patch Status column
Displays icons relating to patch status (see
Monitoring symbols on page 2). If no icon is
displayed, the patch is okay. Click the column
heading to sort the patients by patch status.
Those patients whose patches require
attention appear at the top of the list.
Room-Bed column
Indicates the patient’s room and bed
number. Click the column heading to sort
patients in room-bed number order.
Patient by X column
Displays a list of patients currently being
monitored. By default, this list is sorted by
Name. Click the column heading to sort
patients by Vital Sign Status, with red and
yellow vital sign alerts at the top of the list.
Vital signs columns
When the list displays all patients in a unit,
this column displays only the patients’ names.
However, when a group is selected using the
Group drop-down list, this column displays the
patient name, ID, and date of birth.
These columns display the latest vital signs—
heart rate, respiratory rate, and axillary
temperature—for each patient in the list.
• Vital signs that are within normal limits are
displayed in blue on a black background.
• Vital signs that exceed yellow preset limits
are displayed in black on a yellow
background.
• Vital signs that exceed red preset limits are
displayed in white on a red background.
• If the system receives invalid data,
question marks are displayed.
• If the system has not received vital sign
data for a period of time, dashes are
displayed.
• Dashes are also displayed while a patch is
being activated.
If the Patient list is long, vital sign warnings might appear below the
“bottom” of the Main Screen. To avoid this, use the Group drop-down
list to limit the number of patients shown.
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 1—General Information
Patient History screen
To display the Patient History screen, do one of the following:
•
Select a patient and click the Patient History
button
•
Click one of a patient’s vital signs on the main screen
Always verify in the Patient History screen that the correct patient’s
information is displayed (item A). If it is not, click Main Screen (item
E)
and select the correct patient.
Patient history screen components
Identifier Component
Description
Patient demographic
data
Value and reading time Move the mouse over a data point on the chart
of a vital sign data point to display.
Display Period drop-
Settings button
Displays and allows you to modify (depending on
privileges)
vital sign limits and the
documentation interval.
Main Screen button
Returns you to the main screen.
Vital sign history
Displays the heart rate, respiratory rate, and axillary
temperature data over the selected time period.
Depending on the display period, data points are
displayed as dots or as line segments. Data points
within the set limits are displayed in blue. Data points
outside the yellow limits are displayed in yellow. Data
points outside the red limits are displayed in red.
down list
Displays patient’s name, ID, date of birth, age, and
room/bed number.
Allows you to choose the period of time to display vital
sign data; for example, for the last four hours.
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 2
Using the SensiumVitals Wireless
Monitoring System
Logging in and out
The Wireless Monitoring Application is a web-based application accessed using
Internet Explorer on a standard hospital PC computer. Only authorized
personnel can log in to the Wireless Monitoring Application.
To log in
1. Enter your user ID and appropriate password at the Log in screen.
2. Click Log in.
The main screen appears.
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 2—Using the Wireless Monitoring System
To log out
•
Click Log out in the upper right corner of the main screen.
After a period of inactivity, the application automatically logs out.
Starting patient monitoring
Required equipment
CAUTION—Use of 3M Red Dot 2560 Monitoring Electrodes is
recommended.
•
Patch
•
3M™ Red Dot™ 2560 Monitoring Electrodes (2)
•
Skin cleaning solution
•
° Isopropyl alcohol or a special skin preparation solution can be used.
Clipper
•
Water-resistant plastic or paper medical tape such as 3M Transpore™ or 3M
Transpore™ White
Applying the patch
WARNING—Do not use the SensiumVitals Wireless Monitoring
system on critical care patients.
WARNING—Do not apply the patch on breached or compromised
skin surfaces or on mucosal membranes.
1. Open the patch packaging and inspect the patch to ensure that it is intact and
that the expiration date printed on the packaging has not been reached.
2. Connect each electrode to the patch as shown.
10
TZ202000-IFU Wireless Monitoring System Directions for Use
3.
Without attaching the patch, but using the patch as a guide, locate the two
areas on the patient’s upper torso where the electrodes will be applied.
•
4.
Center the patch horizontally on the upper torso, with the center of the
electrodes on the second intercostal space.
Clip hair from the electrode sites and thoroughly clean the skin with an
approved skin cleansing solution; allow to dry.
•
To avoid allergic reactions to the electrodes, refer to the electrode
manufacturer’s directions.
WARNING—Be sure to place the patch exactly as shown in these
instructions. An improperly-placed patch can return false data.
5. Apply the patch to the patient as follows:
a. Orient the patch so that the temperature sensor points toward the
patient’s non-dominant arm.
b. Peel off the backing from the electrodes and inspect the electrode gel to
make sure that it is intact and not dried out.
c. Apply the patch, making sure it is well centered on the torso with the
center of the electrodes on the second intercostal space, and pressing
lightly.
TZ202000-IFU Wireless Monitoring System Directions for Use
11
6. Apply the temperature sensor as follows:
a. Raise the patient’s arm to 90 degrees and center the axillary section
underneath the axilla.
b.
Gently lift the two attachment points of the temperature sensor and
position them on either side of patient’s shoulder as shown in the
following figure.
c. Secure the temperature sensor to each attachment point location using
medical tape.
To avoid patient discomfort or skin irritation, do not create unnecessary tension
in the coils.
When installed correctly, the coils are only slightly extended and the two
attachment points are at approximately the same level as shown.
7. Pull out the activation tab.
12
TZ202000-IFU Wireless Monitoring System Directions for Use
CAUTION—Make sure the activation tab opening is perfectly
sealed after the patch has been activated.
Doing this helps avoid patch malfunctions due to moisture.
8. Press down on the activation tab opening to seal it shut.
WARNING—Patient interference with the patch can cause false
data to be sent.
9. Advise patient to not remove, pull on, adjust, or otherwise interfere with the
patch.
TZ202000-IFU Wireless Monitoring System Directions for Use
13
Adding patient to wireless monitoring
1. On the main screen of the Wireless Monitoring Application, click Add Patient
to open the patient list.
WARNING—Always verify that the patient’s information is
correct.
2. Do one of the following to open the Add Patient to Wireless Monitoring
screen:
•
Scan the patient’s wristband.
•
Select the appropriate patient from the list, as shown.
You can do either of the following to help you find the patient in the
patient list:
•
Enter the MRN (or patient ID) in the text box to locate the patient.
•
Click any column heading to sort by that column.
If the correct patient’s information is not displayed in the Add Patient to
Wireless Monitoring screen, click Cancel and select the correct patient.
If the correct patient is not listed, it is possible that the patient was
transferred to another unit, or was recently transferred into your unit
and the Hospital Information System has not yet been updated. Verify
the status of the patient in the HIS.
14
TZ202000-IFU Wireless Monitoring System Directions for Use
3. On the Add Patient to Wireless Monitoring screen, do the following:
a. Enter the new patch ID number using one of the following methods:
•
Enter the ID number in the Patch ID text box.
•
Scan the barcode on the patch.
The barcode appears on both the patch and the packaging. If you are
unable to scan the patch at the patient’s bedside, you can use the
patch ID on the packaging instead.
b.
Set a documentation interval for transferring the data into the patient’s
electronic medical record:
i.
Click the Documentation Interval drop-down list.
ii. Select the new time interval.
The Documentation Interval controls how often the system copies data
into the patient’s electronic medical record.
TZ202000-IFU Wireless Monitoring System Directions for Use
15
Standard yellow and red vital sign limits (yellow and red limits) are
defined and set by the hospital for all patients who are being monitored
with the SensiumVitals Wireless Monitoring System. Vital sign limits can
be modified
for a specific patient.
WARNING—Make sure that yellow and red vital sign limits are
appropriate to the patient’s condition.
c. Set vital sign limits as follows:
i.
Click the text box that displays the vital sign limit you wish to change.
ii. Enter different upper and/or lower limits as needed.
Additional user privileges may be required to change some or all vital
sign limits.
d. After completing the required changes, click Add.
A message appears to confirm that the patient was added to monitoring.
4. Click OK to return to the main screen.
When a patient is added to monitoring, allow up to 15 minutes before
the data is available on the main screen.
Monitoring is intermittent. Vital sign data is usually updated once every
2 minutes, but can vary depending on the configuration of your unit.
16
TZ202000-IFU Wireless Monitoring System Directions for Use
Monitoring patients
Monitoring patients
Editing patient settings and vital sign limits
1. On the Patient History screen, click Settings.
The Patient Settings screen appears.
2. To set a different documentation interval, do the following:
a. Click the Documentation Interval drop-down
list. b. Select a different documentation interval.
The Documentation Interval controls how often the system copies data
into the patient’s electronic medical record.
3. To change a vital sign limit, do the following:
a. Click the text box that displays the vital sign limit you wish to change.
b. Enter different upper and/or lower limits as needed.
Additional user privileges may be required to change some or all vital
sign limits.
4. When you have made the required changes, click Save.
A message confirms that the changes have been saved.
5. Click OK to return to the Patient History screen.
TZ202000-IFU Wireless Monitoring System Directions for Use
17
Chapter 2—Using the Wireless Monitoring System
Notifications
WARNING—Always address received notifications, even if they
are not for a patient under your care.
Physiological and system notifications are sent from the Monitoring Server to
the Wireless Monitoring Application and, if set up to do so, a handheld
notification device.
Receiving notifications
Notification types and descriptions
Type
Description
Physiological
Axillary Temperature
Outside of yellow or red preset limits
Heart Rate
Outside of yellow or red preset limits
Respiratory Rate
Outside of yellow or red preset limits
System
Replace Patch
Two hours of use remaining
Replace Patch Now
Patch is no longer functional
Signal Lost
Patch is outside of coverage area beyond a specified
length of time. Caregiver is advised to check on the
patient if it is unknown why the patient is no longer
being monitored.
This notification may also appear if the patch
was improperly activated.
Reading Problem
The system was unable to interpret vital sign data
for several attempts in a row.
This notification may also appear if the patch
was incorrectly attached.
Acknowledging Notifications
When a notification is received, it must be acknowledged in the Wireless
Monitoring Application.
Depending on your system configuration, vital sign notifications may
not be sent until two or more consecutive yellow or red vital sign
statuses are recorded.
Depending on your system configuration, some notifications may not
require acknowledgement.
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TZ202000-IFU Wireless Monitoring System Directions for Use
Monitoring patients
To acknowledge a notification from the Wireless Monitoring
Application
1. At the main screen, click the notification symbol associated with the
appropriate patient.
The Acknowledge Notifications window displays both the physiological
and system notifications for that patient.
2. Click Acknowledge.
A message confirms that notifications have been acknowledged.
3. Click OK to return to the main screen.
Reminder notifications
When a notification is not acknowledged within a specified period of time, a
reminder notification may be sent. Reminder notifications contain the same
information as the original notifications that they refer to.
TZ202000-IFU Wireless Monitoring System Directions for Use
19
Chapter 2—Using the Wireless Monitoring System
Escalation notifications
When a notification is not acknowledged within a specified period of time, an
escalation notification may be sent to another caregiver handheld device.
Escalation notifications contain the same information as the original
notifications that they refer to.
Replacing a Patch
1. Remove the patch, electrodes, and temperature sensor from the patient.
2. Dispose of the patch in accordance with the hospital waste procedure.
WARNING—The patch is a single-use device. After the patch is
removed from a patient, do not reuse the patch, whether on the
same patient or on a different patient.
3.
Apply a new patch to the patient as described in Applying the patch
on page 10.
Updating patch information in the Wireless Monitoring
Application
1. On the main screen, select the patient whose patch was replaced and click
Replace Patch
2. Do one of the following to enter the new patch ID number:
•
Enter the new ID number in the New Patch ID text box.
•
Scan the barcode on the patch.
The barcode appears on both the patch and the packaging. If you are
unable to scan the patch at the patient’s bedside, you can use the patch
ID on the packaging instead.
3. Click Replace.
A message confirms that the patch has been replaced.
4. Click OK to return to the main screen.
20
TZ202000-IFU Wireless Monitoring System Directions for Use
Removing a patient from wireless monitoring
Removing a patient from wireless
monitoring
1. Remove the patch, electrodes, and temperature sensor from the patient.
2. Dispose of the patch in accordance with the hospital waste procedure.
WARNING—The patch is a single-use device. After the patch is
removed from a patient, do not reuse the patch, whether on the
same patient or on a different patient.
3. On the main screen of the Wireless Monitoring Application, select the patient
to be removed from wireless monitoring and click Remove Patient
The Remove Patient from Wireless Monitoring screen appears.
4. Click Remove.
A message confirms that the patient was removed from monitoring.
5. Click OK.
The main screen appears.
TZ202000-IFU Wireless Monitoring System Directions for Use
21
Chapter 2—Using the Wireless Monitoring System
Running a Clinical Data Report
1. From the Actions drop-down list on the main screen, select Clinical Data
Report.
The Clinical Data Report dialog box appears.
2. In the From and To boxes, enter the date range for the report.
Alternatively, click the calendar icons to select the date range from calendars.
3. Select the unit for the report from the Unit drop-down list.
4. Select a patient, or select All patients, from the Patient drop-down list.
•
Select Discharged Patients Only to include only discharged patients in
the report.
5. Click View Report.
The report can take several minutes to generate and be displayed.
You can print a clinical data report by clicking the print icon in the Adobe
Acrobat Reader menu bar.
22
TZ202000-IFU Wireless Monitoring System Directions for Use
Assigning beds to groups
Assigning beds to groups
Beds can be assigned to groups within a unit. A group can then be selected on
the main screen using the Groups drop-down list, and only patients in beds
assigned to that group will appear on the list. Notifications for patients in that
group are sent to the corresponding notification devices, as configured by IT for
the group.
Patients admitted in a unit but without room/bed information can still be
monitored and are considered part of the Default Bed Group. See Step 3,
below.
Additional user privileges are required to use the Assign Beds feature.
Assigning beds to groups
1. From the Actions drop-down list, select Assign Beds.
The Assign Beds screen appears.
TZ202000-IFU Wireless Monitoring System Directions for Use
23
Chapter 2—Using the Wireless Monitoring System
2. Click a cell in the group column to assign a bed to a group.
A blue check mark indicates the assigned group for a bed. A bed can be
reassigned as often as needed.
3.
To set the group to which patients are admitted without room/bed
information assigned, click the Default Bed Group drop-down list and select
a group.
4. Click Save.
A message confirms that your selections have been saved.
5. Click OK to return to the main screen.
24
TZ202000-IFU Wireless Monitoring System Directions for Use
Chapter 3
Troubleshooting
Logging in and out
I am entering the correct user name and password, but the system is
not logging me in
•
Your computer’s CAPS LOCK may be on. If so, turn it off and try again.
•
If that doesn’t work, double-check your user name and password.
•
If your user name and password are correct and the system still won’t log you
in, contact your facility’s IT department for assistance.
Adding a patient
Scanning the patient’s or patch’s bar code doesn’t work
Sometimes bar codes don’t print properly, and scanners have a hard time reading
them. If you attempt to scan a bar code and it doesn’t work, enter the code
manually.
If the problem persists with different bar codes, then you may have a faulty
scanner. Contact your facility’s IT department for assistance.
I need to add a patient to wireless monitoring, but the patient’s name
isn’t in the list
There are several reasons why a patient’s name may not be in the Add patient
to wireless monitoring list:
•
The patient may have already been added to wireless monitoring. Check the
main screen, then follow the procedures under The patient’s name is not
displayed on the main screen on page 26 to see if the patient is already
being monitored.
TZ202000-IFU Wireless Monitoring System Directions for Use
25
Chapter 3—Troubleshooting
•
The patient may have recently been admitted or transferred to your unit,
and the system hasn’t been updated yet.
If neither of the above applies, check with your facility’s IT department for
assistance.
I am unable to access the Assign Bed feature
Additional user privileges are required to assign beds. Ask someone who has these
privileges for assistance.
If you know that you should have access to this feature, but you do not, contact
your facility’s IT department for assistance.
I can’t change the vital sign limits
Additional user privileges may be required to change some or all vital sign limits.
Ask someone who has these privileges for assistance.
If you know that you should have the ability to change vital sign limits, but you do
not, contact your facility’s IT department for assistance.
The patient’s demographic information is incorrect
The SensiumVitals Wireless Monitoring System’s patient information is taken from
the Hospital Information System (HIS). Check with the HIS administrator to make
sure that all information is correct and up to date.
Monitoring a patient
The patient’s name is not displayed on the main screen
If the patient’s name is not visible on the main screen, check the following:
•
Check the Group drop-down list to make sure that the proper group is being
shown, or select All to display all patients being monitored.
•
If there is a scroll bar to the right of the patient list, the list is too long to be
displayed on one screen. Scroll down to see if the patient is farther down the
list.
•
It is possible that the patient was not added to wireless monitoring, even if a
patch was applied and activated. Follow steps 1 and 2 of the procedure Adding
patient to wireless monitoring on page 14. If the patient’s name is on the
Patient List screen, follow the rest of the procedure to add the patient to
wireless monitoring.
•
It is also possible that the patient was transferred to another unit, or was
recently transferred into your unit and the Hospital Information System has
not yet been updated. Verify the status of the patient in the HIS.
If, after doing all of the previous steps, the patient’s name still is not displayed on
the main screen, contact your facility’s IT department for assistance.
26
TZ202000-IFU Wireless Monitoring System Directions for Use
Monitoring a patient
The patient’s vital sign data are not appearing on the main screen
If a patient’s vital sign data aren’t being read by the system, the vital sign
data columns show dashes (--). If this is the case, check the following:
•
Check the Patch column to see if the “Patch Activating” icon (
displayed. If so, wait a few minutes for it to disappear.
) is
NOTE: The patch can take up to 15 minutes in the worst case to
activate and display data on the main screen.
•
Check the Patch column to see if the Out of Range/Signal Lost icon ( ) is
displayed. If so, see The Patch status column displays the Out of Range/ Signal
Lost icon on page 28.
•
Check the Patch column to see if the “Replace Patch” icon ( ) is displayed.
If so, replace the patch following the instructions under Replacing a Patch on
page 20.
•
Make sure that the activation tab has been removed.
•
If you have checked all of these items, properly applied and activated the
patch, and the patient is not out of range, the patch may be faulty. Wait a few
minutes for the next reading. If dashes (--) are still displayed, replace the patch
following the instructions under Replacing a Patch on page 20.
If, after doing all of the previous steps, the vital sign data columns still display
dashes (--), contact your facility’s IT department for assistance.
There are question marks (??) in the patient’s heart rate column
This is normal, but should not happen often. It can be due to temporary electrical
interference, the patient moving in certain ways, or something striking the patch.
However, if the question marks persist, check the following:
•
Make sure that the patch is properly placed on the patient.
•
Make sure that the electrodes are firmly attached to the patch and to the
patient.
•
Replace the monitoring electrodes with fresh electrodes.
•
If the problem persists for longer than a specified period of time, the system
will send a notification to replace the patch. If this is the case, replace the
patch following the instructions under Replacing a Patch on page 20.
If, after doing all of the previous steps, the heart rate column still displays
question marks (??), contact your facility’s IT department for assistance.
There are question marks (??) in the patient’s respiratory rate
column
Due to the nature of impedance pneumography, it is possible that respiratory rate
readings are often not available, especially when the patient is moving. It can take
several minutes after the patient has stopped moving for respiratory rate data to
be
TZ202000-IFU Wireless Monitoring System Directions for Use
27
Chapter 3—Troubleshooting
displayed. However, if the patient is not moving and question marks persist, do the
following:
•
Make sure that the patch is properly placed on the patient.
•
Make sure that the electrodes are firmly attached to the patch and to the
patient.
•
Replace the monitoring electrodes with fresh electrodes.
•
If the problem persists for longer than a specified period of time, the system
will send a notification to replace the patch. If this is the case, replace the
patch following the instructions under Replacing a Patch on page 20.
If, after doing all of the previous steps, the respiratory rate column still displays
question marks (??), contact your facility’s IT department for assistance.
There are question marks (??) in the patient’s temperature column
Temperature readings might become unavailable if the patient is moving or if the
patient’s arm is not covering the temperature sensor completely. It can take several
minutes after the patient’s arm has returned to the proper position for
temperature data to be displayed. Question marks can also be displayed if the
patient experiences a rapid drop in core body temperature.
If question marks persist, check the following:
•
Make sure that the temperature sensor is properly placed on the patient.
•
If the problem persists for longer than a specified period of time, the system
will send a notification to replace the patch. If this is the case, replace the
patch following the instructions under Replacing a Patch on page 20.
If, after doing all of the previous steps, the temperature column still displays
question marks (??), contact your facility’s IT department for assistance.
The Patch status column displays the Out of Range/Signal Lost icon
If the Out of Range/Signal Lost icon (
the following:
) is displayed in the Patch column, check
•
The signal loss may be temporary. Wait a few minutes for the next patch
reading. If the icon goes away, the signal has been restored.
•
If the Out of Range/Signal Loss icon remains, verify the location of the patient.
The patient may have been temporarily moved to an area where there is no
coverage.
•
If the Out of Range/Signal Loss icon is still displayed, and the patient is in the
assigned room, the patch may be faulty. Replace the patch following the
instructions under Replacing a Patch on page 20.
If, after doing the previous steps, the Patch column still displays the Out of Range/
Signal Lost icon, contact your facility’s IT department for assistance.
A patient appears in my group list, but isn’t under my care
Check to make sure that bed assignments are up to date. A bed that another
caregiver is responsible for may have been inadvertently assigned to you.
28
TZ202000-IFU Wireless Monitoring System Directions for Use
Patient History
Also, your group could be the “default group” to which patients without
room/bed information are assigned. The patient will be removed from your
group when the room/bed information has been updated.
It may also be that the patient was recently transferred into your group in the
system, but has not yet been physically moved.
Patient History
Some data points in the Patient History screen are 10 minutes apart
and others are 2 minutes apart
This is normal and not a cause for worry. Vital sign data is usually updated once
every 10 minutes, but can vary depending on the configuration of your unit.
Frequency automatically increases to as much as once every two minutes when
the vital sign data are outside of preset limits.
Some data points in the Patient History screen are yellow or red
when they’re within the vital sign limits
This is normal and not a cause for worry. A data point is marked yellow or red if it
falls outside of the yellow or red vital sign limits at the time it was recorded. If the
vital sign limits are later changed, yellow and red dots may fall within the new
limits.
Some data points in the Patient History screen are blue when they’re
outside the vital sign limits
This is normal and not a cause for worry. A data point is marked blue if it falls
within the yellow vital sign limits at the time it was recorded. If the vital sign limits
are later changed, blue dots may fall outside the new limits.
Removing patients from Wireless
Monitoring
A patient has been discharged, but the patient’s name is still on the
wireless monitoring list
Even if a patient is discharged from a facility, the patient must be manually
removed from wireless monitioring using the procedures under Removing a
patient from wireless monitoring on page 21.
General application questions
Online help doesn’t work
Contact your facility’s IT department.
TZ202000-IFU Wireless Monitoring System Directions for Use
29
Chapter 3—Troubleshooting
Clinical reporting doesn’t work
Contact your facility’s IT department.
Notification questions
There is a notification on the main screen, but the notification was
never sent to my pager
Check to make sure that bed assignments are up to date. The bed you believe you
are responsible for may have been inadvertently assigned to another caregiver.
If you are not receiving pages for any patients, contact your facility’s IT
department to have your pager serviced or replaced.
I am receiving notifications for patients not under my care
WARNING—Always address received notifications, even if they
are not for a patient under your care.
Check to make sure that bed assignments are up to date. A bed that another
caregiver is responsible for may now be assigned to you.
Also, your group could be the “default group” to which patients without room/bed
information are assigned. You will stop receiving notifications when the patient’s
room/bed information has been properly entered.
A patient’s vital sign data is yellow or red, but I didn’t receive a
notification
This is normal and not a cause for worry. Depending on your system configuration,
vital sign notifications may not be sent until two or more consecutive yellow or red
vital sign statuses are recorded.
It is also possible, depending on your system configuration, that notifications are
turned off for your system. Check with your facility’s IT department to verify this.
If you are not receiving pages for any patients, contact your facility’s IT
department to have your pager serviced or replaced.
Error message questions
The message “Internet Explorer cannot display the webpage”
displays when I tried to open the main screen
Try again. If the problem persists, contact your facility’s IT department for
assistance.
30
TZ202000-IFU Wireless Monitoring System Directions for Use
Appendix A
Technical Specifications
Performance specifications
Item
Specification
Heart rate
30–200 beats per minute (bpm) ± 2 bpm
Respiratory rate
5–60 breaths per minute (BPM) ± 2 BPM
Temperature sensor
For axillary temperatures from 89.6°–111.2°F
(32°–44°C) within 0.4°F (± 0.2°C)
Patch specifications
Item
Specification
Patch Weight
15 g
Duration of Use
Up to 5 days
Operating Temperature
50°–113°F (10°–45°C)
Storage Temperature
-4°–140°F (-20°–60°C)
TZ202000-IFU Wireless Monitoring System Directions for Use
31
Appendix A—Technical Specifications
32
TZ202000-IFU Wireless Monitoring System Directions for Use
Appendix B
Compliance and Safety Info
FCC compliance statement (United States)
Patch FCC ID: AEJ-TZ202055R1. Bridge FCC ID: AEJ-TZ202020R1.
These devices comply with Part 15 of the Federal Communications Commission
(FCC) Rules. Operation is subject to the following two conditions:
1. These devices may not cause harmful interference.
2.
These devices must accept any interference received, including interference
that may cause undesired operation.
CAUTION: Changes or modifications to these units not expressly
approved by the party responsible for compliance could void the
user’s authority to operate these units.
These units have been tested and found to comply with the limits for a Class A
digital devices, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a non-residential
installation. These units generate, use and can radiate radio frequency energy and,
if not installed and used in accordance with the manufacturer’s instructions, may
cause interference harmful to radio communications.
Please insure all warning and caution icons noted in this DFU are
reviewed, understood and followed.
TZ202000-IFU Wireless Monitoring System Directions for Use
33
Appendix B—Compliance and Safety Info
Safety
Patch—Safety
Regulations
Compliance Tests
IEC 60529
Degrees of protection provided by enclosure (IP
Code)
IP64 Dust-tight and Splashing
Proof
IEC 60601-1
Medical electrical equipment
General Requirements for Safety
Patient leakage current < 10
µA Dielectric Strength @
500 V
IEC 60601-2-27
Medical electrical equipment
Particular requirements for the safety,
including essential performance, of
electrocardiographic monitoring
equipment
IEC 60601-2-49
Medical electrical equipment
Particular requirements for the safety of
multifunction patient monitoring equipment
Heart rate: 30 to 200 +/- 2 bpm
BF type applied part
ISO 10993
Cytotoxicity
Biological Evaluation of Medical Devices Package Irritation and delayedtype hypersensitivity
ASTM F2475 - 05
Cytotoxicity
Standard Guide for Biocompatibility Evaluation of Physicochemical
Medical Device Packaging Materials
Body temperature: 32°C to 44°C
ISO 80601-2-56
+/Particular requirements for basic safety and
essential performance of clinical thermometers 0.2°
for body temperature measurement
Bridge—Safety
Regulations
Compliance Tests
IEC 60950-1
Information technology equipment
Safety general requirements
Safety for interface with Telecommunication
Network Equipment
FCC Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment. The bridge should be installed and operated with
minimum distance 20 cm between the radiator and your body.
This transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter. IEEE 802.11b or 802.11g operation of this product in the
USA is firmware-limited to channels 1 through 11.
34
TZ202000-IFU Wireless Monitoring System Directions for Use
Electromagnetic compatibility
Electromagnetic compatibility
Patch—Electromagnetic Compatibility
Regulations
Compliance Tests
IEC 60601-1-2
Medical electrical
equipment Collateral
standard: Electromagnetic
Compatibility
- Requirements and tests
Emissions:
IEC 62311
Assessment of electronic
and electrical equipment
related to human exposure
restrictions for
electromagnetic
FCC,
CFR 47, Partfields
15
30 to 230 MHz 40 dBµV/m
230 to 1000 MHz 47 dBµV/m
ESD:
+/- 8 kV Air discharges
+/- 6 kV Contact discharges
RF field:
3 V/m, 80 MHz to 2.5 GHz
Magnetic field:
3 A/m
Frequency:
0 to 300 GHz
Magnetic
flux density:
100,000 to 0.1 µT
Intentional
< 50mV/m @ 3
radiation:
Unintentional radiation @ 10m:
Frequencies (MHz)
dBµV/m
30–88
90
88–216
150
216–960
210
960+
300
FCC, CFR 47, Part 18
Operating frequency: 915 MHz +/-13.0 MHz
EN 300 220-01
Electromagnetic
compatibility and Radio
spectrum Matters (ERM)
Short Range Devices (SRD)
Output power class: 7a, 5 mW
Bridge—Electromagnetic Compatibility
Regulations
Compliance Tests
IEC 60601-1-2
Medical electrical
equipment Collateral
standard: Electromagnetic
Compatibility
- Requirements and tests
Emissions:
30 to 230 MHz 40 dBµV/m
230 to 1000 MHz 47 dBµV/m
ESD:
+/- 8 kV Air discharges
+/- 6 kV Contact discharges
RF field:
3 V/m, 80 MHz to 2.5 GHz
Magnetic field:
3 A/m
TZ202000-IFU Wireless Monitoring System Directions for Use
35
Appendix B—Compliance and Safety Info
Bridge—Electromagnetic Compatibility
Regulations
Compliance Tests
FCC, CFR 47, Part 15
Intentional
< 50mV/m @ 3
radiation:
Unintentional radiation @ 10m:
EN 300 220-01
Electromagnetic
compatibility and Radio
spectrum Matters (ERM)
Short Range Devices (SRD)
36
Frequencies (MHz)
dBµV/m
30–88
90
88–216
150
216–960
210
960+
300
Output power class: 7a, 5 mW
TZ202000-IFU Wireless Monitoring System Directions for Use

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