Fresenius Kabi 490181_Rev_F 2008K@home Machine WetAlert Wireless Wetness Detector In-center User’s Guide

TM

2008K@home

Machine
WetAlertTM Wireless
Wetness Detector
In-center User’s Guide

2008K@home WetAlert Wireless Wetness Detector In-Center
User’s Guide

For software versions 4.14 and above

© Copyright 2012-2014, 2016, Fresenius USA, Inc.—All Rights Reserved

This document contains proprietary information of Fresenius Medical Care Renal Therapies
Group, LLC and its affiliates (“Fresenius Medical Care”). The contents of this document may
not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without
the prior written permission of Fresenius Medical Care.

Fresenius Medical Care, the triangle logo, 2008K@home, 2008, the @ home logo, and WetAlert
are trademarks of Fresenius Medical Care Holdings, Inc., and/or its affiliated companies. All
other trademarks are the property of their respective owners.

Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.

WetAlert device Indications for Use: The Wireless Wetness Detector is indicated for use with

the Fresenius Medical Care 2008K@home hemodialysis machine and is an optional accessory
to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using
the detector must be observed by a trained and qualified person as prescribed by their physician.

2008K@home hemodialysis machine Indications for Use: the 2008K@home hemodialysis
machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The
2008K@home hemodialysis machine is also indicated for hemodialysis in the home and must be
observed by a trained and qualified person as prescribed by their physician.

The WetAlert device is for use with the WetAlert Starter Kit (P/N 190893) or the WetAlert
Retrofit Kit (P/N 190442) and requires special hardware for the 2008K@home hemodialysis
machine. Without a kit installed, the machine cannot receive wireless signals from the WetAlert
device.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 1

Table of Contents

The WetAlert Wireless Wetness Detector .................................................. 3

Description ...................................................................................... 3

General Warnings ........................................................................... 4

Before Treatment ....................................................................................... 6

Activating the WetAlert Device ................................................................... 8

Activating the WetAlert Device (continued) .............................................. 10

Starting Treatment with the WetAlert Device ........................................... 12

Troubleshooting ....................................................................................... 14

Restarting a Treatment ................................................................. 16

Reading Drop Icon Status ............................................................. 17

After Treatment ........................................................................................ 18

WetAlert Device Care .................................................................... 18

WetAlert Device Storage ............................................................... 18

Appendix .................................................................................................. 20

Setting the Wireless Wetness option ............................................. 21

WetAlert Spare Parts .................................................................... 22

WetAlert Device Disposal .............................................................. 22

WetAlert Device RF Transmitter Characteristics ........................... 22

Quality of Service .......................................................................... 22

Manufacturer’s Electromagnetic Compatibility (EMC) Declaration 23

Additional Information ................................................................... 26

2 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

The WetAlert Wireless
Wetness Detector

Description

The WetAlert wireless wetness detector is a disposable device that can
sense blood leaks. During the treatment, the WetAlert device transmits
radio signals to the 2008K@home hemodialysis machine and will alert the
machine if the device detects a blood leak. During a wetness alarm, the
2008K@home hemodialysis machine will automatically stop the blood
pump, close the venous clamp, display a visual alarm, and sound an audible
alarm.

The WetAlert device should be placed at the venous access site.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 3

General Warnings

Federal Communication Commission (FCC) Interference Statement

This equipment has been tested and found to comply with Part 15 of the
FCC Rules. Operation is subject to the following two conditions: (1) this
device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired
operation.

This equipment generates, uses, and radiates radio frequency energy and, if
not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:

 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and receiver.
 Connect the equipment into an outlet on a circuit different from that to

which the receiver is connected.

 Consult the dealer or an experienced radio/TV technician for help.

Changing or modifying the WetAlert device without the expressed written
consent of Fresenius Medical Care North America could void the user’s
authority to operate the equipment.

See the Manufacturer’s Electromagnetic Compatibility (EMC) declaration
in the 2008K@home User’s Guide (P/N 490180) or on page 23 of these
instructions for more information.

Warning: Radio signals can interfere with the WetAlert device.
Particularly no “Ham” or Amateur radio operating in frequency
range of 430Mhz to 450Mhz should be used in the vicinity of the
WetAlert device. If radio signal interference occurs, the WetAlert
device may not detect a blood or fluid leak and therefore the
machine will not alarm.

The 2008K@home hemodialysis machine monitors for radio
signal interference. If the machine locates interference, it will
display a “Wetness No Comm.” warning message and an
audible alarm will sound. Possible sources of interference include
any device operating in the frequency range of 430Mhz to 450Mhz
like portable amateur radios, mobile amateur radio located in a
vehicle, fixed location amateur radios, and wireless video cameras.

For exact separation distance recommendation, please refer to the
Manufacturer’s EMC Declaration statement provided in the
2008K@home User’s Guide (P/N 490180) or on page 23 of these
instructions.

4 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Warning: Keep vascular access sites uncovered and monitored.
Machine alarms do not sound in every blood loss situation.

Warning: External radio frequency disturbances in the same

range as the WetAlert device may prevent you from activating the
WetAlert device. If the WetAlert device is not activated, it will
not cause the machine to alarm if wetness is detected.

Warning: Do not use devices

emitting strong electromagnetic
radiation such as portable phones, radio equipment (walkie­talkies, etc.), radio transmitters, and like equipment near your
machine. Improper operation may result.

Cellular phones and WiFi-connected devices may be
conditionally allowed. However, if any interference is noted,
such as false pressure readings that disappear when the external
signal is removed, it is recommended to move the cellular
phone at least ten feet away from the 2008K@home
hemodialysis machine when making or receiving phone calls.
If a WiFi-connected device (e.g. laptop computers, tablet
devices, smartphones) is found to cause interference, it is
recommended to use that device at least four feet away from
the 2008K@home hemodialysis machine.

distance recommendation, please refer to the Manufacturer’s
EMC Declaration statement provided in the 2008K@home User’s
Guide (P/N 490180) or on page 23 of these instructions.

Warning: The machine’s modules and internal hydraulics involve

fluids. Fluid leaks may cause excess fluid removal from the
patient. Correct the problem immediately or take the machine out
of service. Spills can cause slips and falls; clean up spills
immediately. To contain such spills, the machine should be on a
spill-tolerant surface.

For exact separation

Caution: System leaks may occur. Unattended operation of the
machine (for example, during disinfection at night) may result in
flooding and can cause property damage. Spills can cause damage
to carpeting and other surfaces. Clean up spills immediately.

Caution: If the WetAlert device is to be used in a location with

more than one WetAlert device equipped machine, the ‘In Center’
option must be set; see page 21.

Note: If the machine displays the message “Wetness Low
Battery”, the WetAlert device must be replaced before the next

treatment.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 5

Note: If the machine displays the message “Wetness Not
Active”, the WetAlert device must be re-activated by touching the

metal pattern on the bottom of the device again with a gauze pad
damp with 1:100 bleach.

Before Treatment

Gather supplies Label WetAlert device

6 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Gather supplies

Follow your clinic’s instructions to set up the 2008K@home hemodialysis
machine, using the 2008K@home User’s Guide (P/N 490180) as a
reference. Use these steps before starting the Tx Clock to activate the
WetAlert device.

Supplies Needed:

 1-2 layers of 2x2 gauze
 1:100 bleach
 WetAlert device
 Permanent marker (to label the WetAlert device for the first time)
 Tape
 Gloves

Warning: Splashes may occur when using bleach. Use
appropriate Personal Protection Equipment (PPE).

Note: Fresenius Medical Care recommends using either of the
following medical tapes to secure the WetAlert device to the
patient:

 1527-1 (FMC P/N 16-1527-7) Clear 3M Transpore
 1532-1 (FMC P/N 16-5321-0) White 3M Micropore Plus

Using a stronger (stickier) tape may pull the label off the
WetAlert device when removing the tape.

Label WetAlert Device if not yet labeled

Write the patient’s name or ID number on the WetAlert label so it is
patient-specific. When activating a WetAlert device for the first time, write
an expiration (Exp) date of six months from today’s date on the device’s
label. Fresenius Medical Care recommends replacing the WetAlert device
every six months or when a “Wetness Low Battery” alarm occurs,
whichever comes first.

To write on the WetAlert device label:

1. Pull back the label flap to expose the Exp and blank line on the label.

2. Write the name/ID number and the expiration date with a fine-tipped

permanent marker.

3. Peel the white plastic backing off the flap to expose the sticky underside

of the flap.

4. Firmly press the sticky flap over the label to cover the whole label and

protect it.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 7

Activating the WetAlert Device

1 2

8 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

1 Check for Drop icon

The 2008K@home hemodialysis machine displays a gray Drop icon in
the Dialogue Box when the Wireless Wetness option has been set in
Service Mode.

device to activate.

the screen and make sure the Drop icon appears.

Note: If the Drop icon does not appear in the Dialogue Box, the
Wireless Wetness option must first be set in Service Mode; turn to
page 21.

The WetAlert device is not activated until the Drop icon is green.

Dialogue Box will remind you to touch the wetness detector when you
reach the “Tx Connect: Start Treatment” screen.

about the Drop icon, see page 17.

Note: The WetAlert device can be used in two different ways,
depending on the location of the 2008K@home hemodialysis
machine: in-center or at home. This option is set in Service Mode
(see page 21 for more information).

 The In-Center setting is for use in locations with more than one

WetAlert device equipped machine. (When the In-Center
option is set, the UF Profile button is displayed on the “Home”
screen.) This user’s guide is written for In-Center use.

 The Home setting is only for use in locations with one WetAlert

device equipped machine to prevent interference between
machines. (When the Home option is set, no UF profiles are
available from the “Home” screen.) Use the 2008K@home
WetAlert Home User’s Guide (P/N 507939) for instructions
with this setting.

2 Touch detector

To activate the WetAlert device: Create a wetness signal within six feet of
the machine by touching the metal pattern on the bottom of the WetAlert
device for at least three seconds. The WetAlert device will cause an alarm
when it comes into contact with conductive fluids like blood or 1:100
bleach. Fresenius Medical Care North America recommends using gauze
damp with 1:100 bleach to activate it. The metal pattern is the part of the
WetAlert device that can sense fluid, be sure that this part is placed directly
over the vascular access when instructed in step 7 on page 13 of these
instructions.

This means that the machine is searching for a WetAlert

Look at the Dialogue Box in the upper right corner of

The

For more information

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 9

Activating the WetAlert Device
(continued)

3 4

10 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

3 Press 1

The machine will display the message “Wetness Detected Press 1 to
learn” in the Dialogue Box. Press the 1 key on the Data Entry Keypad to

'learn' this WetAlert device so other WetAlert devices in the treatment area
will not cause this machine to alarm.

Note: The 1 key on the Data Entry Keypad is only used to ‘learn’
the device. Pressing the RESET key will clear the alarm during
treatment.

4 Check for green drop

The Drop icon in the Dialogue Box will turn green, indicating that the
WetAlert device is activated. Next you must test the device.

Note: The 2008K@home hemodialysis machine periodically
checks for communication from the activated WetAlert device
when the Tx Clock is running. If the machine temporarily loses
contact with the WetAlert device, the machine will display a
“Wetness No Comm.” warning in the Status Box. Press the
RESET key to clear the warning and continue.
The audible alarm will sound only the first time this warning
occurs. Afterward, the machine will display the “Wetness No
Comm.” message in the Status Box only.
If this warning occurs frequently, either locate and remove the
source of radio frequency interference, or discontinue using the
WetAlert device. See page 4 for more information on
interference. If the machine permanently loses contact with the
WetAlert device, it will display a “Wetness Not Active” alarm
and sound an audible alarm.
Note: If the same “Wetness Detected” alarm is reset three
times within 10 minutes, the Dialogue Box will display the
message “Press 0 to disable Wetness Detector.” To continue
using the WetAlert device, press the RESET key to clear the
alarm

Or

Press the 0 key on the Data Entry Keypad to deactivate the device
for the remainder of the treatment. The Drop icon in the Dialogue

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 11

Box will be yellow to show the WetAlert device is deactivated.

Starting Treatment with the
WetAlert Device

5 Retest 6 7 Place

WetAlert

device

12 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

8 9

5 Test WetAlert device

You must make certain the activated WetAlert device is linked to this
machine. Touch the device again to cause a wetness signal. Make sure that
an audible alarm sounds and the Status Box turns red and displays the
message “Wetness Detected #1”. The Drop icon in the Dialogue Box
will turn red to indicate wetness sensed.

Note: If the device still does not cause an alarm after repeated
attempts, you will not be able to use the WetAlert device for this
treatment. For more information, see page 16 of the
Troubleshooting section.

6 Press RESET

Press the RESET key to clear the alarm. The Drop icon in the Dialogue
Box will turn back to green.

7 Place WetAlert device

Place 1-2 layers of gauze over the secured venous fistula needle. Place the
metal pattern bottom side of the WetAlert device directly over this gauze
and secure it with tape.

Warning: Do not use more than two layers of gauze between the
vascular access site and the WetAlert device. Do not place tape
directly over gauze before placing the device on gauze. Do not
use additional bandages or cover the vascular access site with a
blanket. Doing so may allow a blood leak to go undetected.
Undetected blood leaks can cause serious injury or death.

Warning: When placing the WetAlert device, be careful not to

create excessive pressure on the vascular access. Doing so may
cause infiltration or damage to the vascular access.

8 Touch Tx Paused

9 Press CONFIRM

Touch the Tx Paused button then press the CONFIRM key on the Data
Entry Keypad. This will start the Tx Clock. Continue the treatment as
prescribed.

Note: If the WetAlert device senses blood, do the following:

1. Press the Mute key to silence the alarm.

2. Correct the condition causing the alarm.

3. Press the RESET key to start the blood pump again.

4. Clean and dry the WetAlert device with 1:100 bleach (see

“WetAlert Device Care” on page 18).

5. Place the WetAlert device back on the vascular access as

described in Step 7 above.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 13

Troubleshooting

The following troubleshooting section is a guide to help you troubleshoot
WetAlert device alarms, warnings, or advisory messages quickly. For a
complete list of alarm messages, please see the Troubleshooting section of
the 2008K@home User’s Guide (P/N 490180).

Messages shown in the Status Box and Dialogue Box are listed
alphabetically. These messages are triggered by conditions and events that
occur in the machine during operation. The messages will reset when the
condition causing them is corrected. In some cases, you must reset them
yourself. The LED light on the RESET key will flash if the alarm may be
reset.

Note: Doing the recommended action may or may not clear the
alarm, warning, or advisory messages displayed. Follow your
facility’s instructions.

Note: If you have any questions, please call Fresenius Medical

Care Technical Support anytime at [phone].

If additional information exists for an alarm or warning, the Help screen­button will flash in the bottom right corner of the touch screen. The
2008K@home hemodialysis machine will display the following on the
“Help” screen:

 Message Meaning
 Action Required

If a message is longer than the space provided allows, use the Up/Down
arrow (/) keys on the data entry keypad to scroll up or down to view

the rest of the message.

At the end of the Troubleshooting section is also a procedure for restarting
the treatment and a table explaining the different WetAlert Drop icon states.

14 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Message Meaning Action Required

Press 0 to
disable
Wetness
Detector

The WetAlert device has
alarmed three times in
ten minutes.

To continue using the WetAlert device that is
alarming, press the RESET key.

Or,
To stop using the alarming WetAlert device, press

the 0 key on the Data Entry Keypad. The alarming
WetAlert device will no longer be linked to the
machine. It will not sense wetness until reactivated
with a new treatment.

Release
Wetness
Detector

Touch
and Hold
Wetness
Detector

Touch
Wetness
Detector

Wetness
Detected

Wetness
Detected
Press 1 to
learn

Wetness
Learn
Failed

The WetAlert device is
being linked to the
machine.

The machine is searching
for a WetAlert device in
range so it may link to it.

The WetAlert device
needs to be activated at
this time.

The WetAlert device has
sensed wetness.

The machine has
sensed a WetAlert
device as expected.

The selected WetAlert
device was not linked to
the machine.

Stop touching the selected WetAlert device’s sensor
on the bottom of the device.

Touch the metal sensor on the bottom of the
WetAlert device so as to cause a wetness signal.

Touch the WetAlert device’s metal sensor on the
underside then do one of the following:

 For In Center (UF profiles available on the

“Home” screen), press the 1 key to continue.

 For Home mode (no UF Profiles available on the

“Home” screen), press the RESET key to
continue

1. Press the Mute key to silence the alarm.

2. Correct the condition causing the alarm.

3. Press the RESET key to start the blood pump
again.

4. Clean and dry the WetAlert device with 1:100
bleach (see "WetAlert Device Care" on page

18).

5. Place the WetAlert device back on the vascular
access as described on page 13.

Press the 1 key to link the alarming WetAlert device
to the machine.

If you do not want to link this WetAlert device to the
machine, press the RESET key.

Select and confirm the desired Wetness Detector
toggle-button again before trying to activate the
device.

Wetness
Learn
Start

Wetness
Learn
Success

Wetness
Learned
Already

The WetAlert device is
ready to be linked to the
machine.

The selected WetAlert
device is successfully
linked to the machine.

The user is attempting
to learn a WetAlert
device that is already

Follow the prompts in the Status Box to link the
WetAlert device to the machine.

No action is necessary.

The selected WetAlert device is already linked to
this machine.

linked to this machine.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 15

Message Meaning Action Required

Wetness
Low
Battery

Wetness
No
Comm.

The WetAlert device’s
battery is almost empty.

The machine has
temporarily lost contact
with the WetAlert
device.

Press the RESET key to clear the alarm. Replace
the failing WetAlert device before the patient’s next
treatment.

Press the RESET key to clear the warning. If this
warning occurs frequently, either locate and remove
the source of radio frequency interference, or
discontinue using the WetAlert device. See page 4
for more information on radio interference.

To disable this WetAlert device:

1. Touch the metal sensor on the underside of the

device to cause an alarm and then press the
RESET key.

2. Repeat step 1.

3. Touch the metal sensor on the underside of the

device to cause a third Wetness Detected
alarm. This time press the 0 key on the Data
Entry Keypad. The alarming WetAlert device
will no longer be linked to the machine. It will
not sense wetness until reactivated with a new
treatment.

Wetness
Not Active

The machine has lost
contact with the WetAlert
device.

Or you must activate the
WetAlert device before
beginning the treatment.

Wetted
After
Learn

Wetted
Before
Learn

The WetAlert device was
touched too late when
learning the device.

The WetAlert device was
touched too soon when
learning the device.

Restarting a Treatment

If the WetAlert device cannot be linked to the machine after repeated tries,
another troubleshooting step is to reset the entire treatment before blood is
sensed and the Tx Clock is started.

To restart the treatment: Press the Down Arrow () key on the control
panel and the CONFIRM key at the same time. Then press the
CONFIRM key again to confirm a new treatment and re-enter all the
parameters. You will be prompted to link a WetAlert device again at the
end of the setup process.

If you are still having trouble, please contact Technical Services at (800)
227-2572.

Touch the metal sensor on the bottom of the
WetAlert device to link it to the machine. Press the
RESET key to clear the message.

Select and confirm the desired Wetness Detector
toggle-button again. Touch and hold the device
when prompted in the Status Box.

Select and confirm the desired Wetness Detector
toggle-button again. Touch and hold the device
when prompted in the Status Box.

16 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Reading Drop Icon Status

The Drop icon in the Dialogue Box indicates whether or not the
primary WetAlert device is ready for the treatment. See the table
below for an explanation of each Drop icon status.

Drop Color Status Meaning

No Drop

WetAlert

option not set

in Service

Mode

The Wireless Wetness (WetAlert) option was not set in
Service Mode.

No WetAlert device can be used during treatment.

The Wireless Wetness (WetAlert) option was set in
Service Mode, but the device has not been activated
yet. The machine will display “Touch Wetness
Detector” in the Dialogue Box when entering the “Tx

Gray

WetAlert

device not yet

enabled

Connect: Connect” screen from the “Tx Connect:
Flush” screen. If the Tx Connect screens are skipped,
this message will appear when blood is sensed and
you attempt to start the Tx Clock.

The WetAlert device is not ready for use during
treatment.

You have correctly setup the WetAlert device, either
during the Tx Connect screens or before running the
Tx Clock.

The WetAlert device will cause an alarm when it comes
into contact with conductive fluids like blood or 1:100
bleach. The WetAlert device is ready for use during

Green

WetAlert
device is

enabled

treatment.

The activated WetAlert device has detected wetness.
A blood alarm is occurring. Pressing the RESET key
will clear the alarm and the icon will be green. If a
device alarms three times within ten minutes, the

alarm

Red

Dialogue Box will display a message allowing the
operator to disable the WetAlert device.

Correct the condition causing the alarm before
continuing with treatment.

The activated WetAlert device was disabled (within a
period of ten minutes, after its wetness alarm was reset

Yellow

WetAlert
device is
disabled

twice, the 0 (zero) key was pressed during the third
alarm).

The WetAlert device is not active and is not able to
detect wetness for the duration of the treatment

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 17

After Treatment

WetAlert Device Care

The WetAlert device should be cleaned if it comes in contact with blood
during the treatment and after every treatment. It can be cleaned with very
dilute (1:100) bleach. Freshly prepared dilute bleach solution (1:100) is
currently recommended by the Center for Disease Control as a suitable
disinfectant for the Hepatitis virus. Because surface contamination is the
general mode of transmission for this type of virus, thorough cleaning of
the WetAlert device is essential.

Caution: Do not use cleaners containing acetone (for example,
nail polish remover) to clean the WetAlert device. Acetone will
damage the surface of the WetAlert device's plastic case.

WetAlert Device Storage

Wipe the WetAlert device so it is dry before storing it. The storage
location should be at room temperature; do not allow the WetAlert device
to freeze. Store the WetAlert in a clean, dry location away from conductive
materials like metal. Storing the WetAlert device on a conductive surface
or in a conductive liquid bleach or other disinfectant will reduce the battery
life.

18 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

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WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 19

Appendix

Set
In Center
option

Select Wireless Wetness

option

20 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Setting the Wireless Wetness option

Caution: Only qualified people authorized by your facility’s
medical director or by Fresenius Medical Care may set the
Wireless Wetness option in Service Mode.
Note: The ‘In Center’ option must be set if you are using more
than one WetAlert device equipped machine. If it is not already
set: In Service Mode, on the “Options: Treatment Options”
screen, touch the In Center Set up toggle-button to set the option
to ‘In Center’ and press the CONFIRM key again.

To set up the 2008K@home hemodialysis machine for use with the
WetAlert device, go to the “Module Options” screen in Service Mode.
Touch the Wireless Wetness toggle-button to set the option to ‘Yes’ then
press the CONFIRM key to confirm your selection. The WetAlert device
may now be activated during treatment setup.

Wireless Wetness: ‘In Center’ option

No other setup is required.

Note: After you set the Wireless Wetness toggle-button to
‘Yes’, two more wetness detector buttons will appear below the
button. These buttons are not for use with these instructions and
should be ignored.

Wireless Wetness: ‘Home’ option

No other setup is required if only one WetAlert device equipped machine is
used in your location. Use the 2008K@home WetAlert Home User’s
Guide (P/N 507939) for instructions.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 21

WetAlert Spare Parts

Antenna P/N 190882

Note: WetAlert spare parts can be ordered through Fresenius
Medical Care Technical Services at [phone].

Note: Additional WetAlert devices (P/N 190988) are a prescription
item and must be ordered through Fresenius Medical Care
Customer Service at [phone].

WetAlert Device Disposal

The WetAlert device is not intended for use beyond the life of its battery.
Disinfect the WetAlert device before disposing of it. You must comply
with all local regulations regarding battery and circuit board recycling.

WetAlert Device RF Transmitter Characteristics

Radio Frequency (RF): 433.92Mhz
Power: 30 microwatts
Effective Range: Up to six feet
Modulation: ASK (Amplitude Shift Keying)
U.S. FCC ID #: UO20906
Canada Certification #: 6776A-0906

The Wireless Wetness Detector System operates a proprietary wireless
protocol that does not contain patient specific data and does not support
control of the 2008K@home hemodialysis machine. The wireless protocol
reports only wetness status. Wireless security for the signal from the
wetness detector is assured via internal checksum techniques, timing of the
signal data protocol, and a unique 24-bit identification number in each
wireless detector.

Quality of Service

The 2008K@home hemodialysis machine monitors for radio signal
interference. If the 2008K@home hemodialysis machine detects
interference, it will display a “Wetness No Comm.” warning message and
an audible alarm will sound. Possible sources of interference include any
device operating in the frequency range of 430Mhz to 450Mhz like portable
amateur radios, mobile amateur radio located in a vehicle, fixed location
amateur radios, and wireless video cameras.

For separation distances, see the Manufacturer's EMC Declaration on the
next page.

22 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Manufacturer’s Electromagnetic Compatibility (EMC) Declaration

The 2008K@home hemodialysis machine has been certified to the requirements of
ANSI/AAMI/IEC 60601-1-2 within the scope of equipment intended to be used in

(1)

institutional environments, such as hospitals

. This certification deems the
2008K@home Hemodialysis Machine to be safe with regards to emissions and
immunity to electromagnetic energy when used in institutional environments and
does not guarantee against interference upon common household electronics

(2)

when used in the home.

(1)

Emissions testing of the machine was performed using the limits for CISPR 11 Group
1, Class A which are specified for equipment intended to be used in institutional
environments (such as hospitals) and not in homes (which typically requires Group 1,
Class B limits). Therefore, use of the 2008K@home hemodialysis machine in residential
environments may result in interference with some types of broadcast receivers such as
televisions and radios. Should such interference occur, it will not permanently affect
those receivers and can be reduced or eliminated by repositioning of the receiver or the
2008K@home hemodialysis machine.

(2)

In order to assure the safety of the 2008K@home hemodialysis machine as well as
other medical devices when used with the 2008K@home hemodialysis machine in the
home environment, a detailed technical analysis was performed. This analysis has shown
that the emissions levels of the 2008K@home hemodialysis machine are significantly
below the immunity requirements of ANSI/AAMI/IEC 60601-1-2 and therefore are not
likely to impact the safe operation of other medical devices used within the proximity.

Guidance and manufacturer’s declaration – electromagnetic emissions

The 2008K@home hemodialysis machine is intended for use in the electromagnetic
environment specified below. The customer or user of the 2008K@home hemodialysis
machine should ensure it is used in such an environment.

Emissions

test

RF
Emissions
CISPR 11

RF
Emissions
CISPR 11

Harmonic
emissions

IEC 61000­3-2

Voltage
fluctuations/

flicker
emissions

IEC 61000­3-3

Compliance Electromagnetic environment – guidance

Group 1

Class A

Not

applicable

Not

applicable

The 2008K@home hemodialysis machine uses RF energy
only for its internal functions. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.

The 2008K@home hemodialysis machine is suitable for use
in all establishments other than domestic, and may be used
in domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the following
warning is heeded:

Warning: When the 2008K@home hemodialysis machine is
used in home environments, it may cause interference with
some types of broadcast receivers such as televisions or
radios. This interference is not harmful to such equipment
and is only temporary. Should such interference occur, it can
sometimes be reduced or eliminated by minor repositioning
of the 2008K@home hemodialysis machine.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 23

Guidance and manufacturer’s declaration – electromagnetic immunity

The 2008K@home hemodialysis machine is intended for use in the electromagnetic
environment specified below. The customer or the user of the 2008K@home hemodialysis
machine should assure that it is used in such an environment.

Immunity test

Electrostatic
discharge
(ESD)

IEC 61000-4-2

Electrical fast
transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage Dips,
short
interruptions,
and voltage
variation on
power supply
input lines

IEC 61000-4­11

IEC 60601 test
level

±8 kV contact

±15 kV air
(Level 4)

±2 kV for power
supply lines

±1 kV for
input/output
lines

±1 kV line(s) to
line(s)

±2 kV line(s) to
earth

<5 % U

T

(>95 % dip in

U

)

T

for 0.5 cycles

40 % U

(60 % dip in U

T

T

for 5 cycles

70 % U

(30 % dip in U

T

T

for 25 cycles

<5 % U

T

(>95 % dip in

U

)

T

for 5 seconds

Compliance
level

±8 kV contact

±15 kV air

(Level 4)

±2 kV for power
supply lines

±1 kV for
input/output
lines

±1 kV line(s) to
line(s)

±2 kV line(s) to
earth

<5 % U

(>95 % dip in

U

)

T

for 0.5 cycles

40 % U

)

(60 % dip in U

for 5 cycles

70 % U

(30 % dip in U

)

for 25 cycles

<5 % U

(>95 % dip in

U

)

T

for 5 seconds

Electromagnetic environment –
guidance

Can be used in a dry location
(minimum 10% relative humidity)

Mains power quality should be that
of a typical commercial and/or
hospital environment.

Mains power quality should be that
of a typical commercial or hospital
environment.

T

Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
2008K@home hemodialysis
machine requires continued
operation during power mains

T

interruptions, it is recommended
that the 2008K@home

)

T

hemodialysis machine be powered
from an uninterruptible power
supply or a battery.

T

)

T

T

Power­Frequency
(50/60 Hz)
magnetic field

3 A/m 3 A/m

Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.

IEC 61000-4-8

NOTE UT is the a.c. mains voltage prior to application of the test level.

24 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Guidance and manufacturer’s declaration – electromagnetic immunity

The 2008K@home hemodialysis machine is intended for use in the electromagnetic
environment specified below. The customer or the user of the 2008K@home hemodialysis
machine should assure that it is used in such an environment.

Immunity test

IEC 60601
test level

Compliance
level

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to
80 MHz

3 V/m

80 MHz to

2.5 GHz

3 Vrms

150 kHz to 80
MHz

3 V/m

80 MHz to 2.5
GHz

Electromagnetic environment –
guidance

Portable and mobile RF communications
equipment should be used no closer to any
part of the 2008K@home hemodialysis
machine, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

If abnormal performance is observed such
as TMP alarms or blood leak alarms,
additional measures may be necessary,
such as re-orienting or relocating the
equipment.

Recommended separation distance

1.2 P

1.2 P 80 MHz to 800 MHz

2.3 P 800 MHz to 2.5 GHz

where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).

Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,

a

should be less than the

compliance level in each frequency range.

Interference may occur in the vicinity of
equipment marked with the
following symbol:

b

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the 2008K@home
hemodialysis machine is used exceeds the applicable RF compliance level above, the
2008K@home hemodialysis machine should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re­orienting or relocating the 2008K@home hemodialysis machine.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 25

Recommended separation distances between

portable and mobile RF communications equipment and the 2008K@home

hemodialysis machine

The 2008K@home hemodialysis machine is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of
the 2008K@home hemodialysis machine can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the 2008K@home hemodialysis machine as recommended
below, according to the maximum output power of the communications equipment.

Rated maximum output

power of

transmitter

W

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and people.

Separation distance according to frequency of transmitter

m

150 kHz to 80

MHz

d = 1.2 P

80 MHz to 800

MHz

d = 1.2 P

800 MHz to 2.5

GHz

d = 2.3 P

Additional Information

For more information, please contact:

Fresenius Medical Care Fresenius Medical Care

4040 Nelson Avenue Canada Technical Support
Concord, CA 94520 [phone]
[phone]
www.FMCNA.com

Manufactured by
Fresenius Medical Care

4040 Nelson Avenue
Concord, CA 94520
[phone]

26 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F 27

28 WetAlert Wireless Wetness Detector In-Center User’s Guide P/N 490181 rev F

Indications for Use: The WetAlert wireless wetness detector is indicated for use with the Fresenius Medical Care 2008K@home
hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home

hemodialysis using the detector must be observed by a trained and qualied person as prescribed by a physician.

Caution: Federal (US) law restricts these devices to sale by or on the order of a physician or other licensed practitioner. Read the
Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects,
and precautions, see full package labeling available at www.fmcna.com.

P/N 490181