Fresenius Kabi 507939_Rev_G 2008K@home Machine WetAlert Wireless Wetness Detector Home User’s Guide

2008K@homeTM Machine
WetAlertTM Wireless
Wetness Detector
Home User’s Guide

2008K@home WetAlert Wireless Wetness Detector Home
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 (U.S.) law 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 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.

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 1

Table of Contents

Table of Contents ...................................................................................... 2

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

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

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

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

Activating your WetAlert Device ................................................................. 8

Activating your 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 .................................................................................................. 19

WetAlert Spare Parts .................................................................... 19

WetAlert Device Disposal .............................................................. 19

WetAlert Device RF Transmitter Characteristics ........................... 19

Quality of Service .......................................................................... 19

Manufacturer’s Electromagnetic Compatibility (EMC) Declaration 20

Additional Information ................................................................... 23



2 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

The WetAlert Wireless
Wetness Detector

Description

The WetAlert wireless wetness detector is a disposable device that can
sense blood leaks. During your treatment, the WetAlert device transmits
radio signals to your 2008K@home hemodialysis machine and will alert
your machine if the device detects a blood leak. During a wetness alarm,
your 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 your venous access site.

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 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 Renal Therapies 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 20 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 your
machine will not alarm.

The 2008K@home hemodialysis machine monitors for radio signal
interference. If your 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 your
2008K@home User’s Guide (P/N 490180) or on page 20 of these
instructions.

4 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

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 WiFi­connected 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.

recommendation, please refer to the Manufacturer’s EMC
Declaration statement provided in the 2008K@home User’s Guide
(P/N 490180) or on page 20 of these instructions.

Warning: Your 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 distance

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.

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 5

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 the 2008K@home WetAlert Wireless
Wetness Detector In-Center User’s Guide (P/N 490181) for more
information.

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

treatment.

Note: If your 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 Home User’s Guide P/N 507939 rev G

Gather supplies

Follow your clinic’s instructions to set up your 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 your 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 Renal Therapies 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 your WetAlert device for the first
time, write an expiration (Exp) date of six months from today’s date on
your device’s label. Fresenius Renal Therapies 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 Home User’s Guide P/N 507939 rev G 7

Activating your WetAlert
Device

1 2

8 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

1 Check for Drop icon

Your 2008K@home hemodialysis machine displays a gray Drop icon
in the Dialogue Box to show that the Wireless Wetness option is set.
This means that your machine is searching for a WetAlert device to
activate. Look at the Dialogue Box in the upper right corner of the
screen. Make sure the Drop icon appears.

Note: If the Drop icon does not appear in the Dialogue Box,
your machine is not properly set up to use the WetAlert device.
Contact your Home Therapies Nurse for more information.

Your WetAlert device is not activated until the Drop icon is green. The
Dialogue Box will remind you to touch your wetness detector when you
reach the “Tx Connect: Start Treatment” screen. For more information
about the Drop icon, see page 17.

2 Touch detector

To activate your WetAlert device: Create a wetness signal within six
feet of your machine by touching the metal pattern on the bottom of the
WetAlert device for at least three seconds.

Note: Your WetAlert device will cause an alarm when it
comes into contact with conductive fluids like blood or 1:100
bleach. Fresenius Renal Therapies recommends using gauze
damp with 1:100 bleach to activate it.

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 9

Activating your WetAlert
Device (continued)

3 4

10 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

3 Press RESET

Your machine will alarm and display the message “Wetness Detected”
in the Status Box. The Drop icon will also turn red. Press the RESET
key to clear the alarm.

Note: If your machine instead displays the message “Wetness
Detected Press 1 to learn,” your machine is not properly set

up for use with these instructions. Contact your Home
Therapies Nurse for more information.

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

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 11

Starting Treatment with the
WetAlert Device

5 6 7 Place

WetAlert

device

12 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

8 9

5 Test WetAlert device

You must make certain your WetAlert device is linked to your 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”. The Drop icon in the Dialogue Box
will turn red to indicate wetness sensed.

Note: If your device still does not cause an alarm after repeated
attempts, you will not be able to use your 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 on the gauze
directly over your venous access site and secure the device with tape.

Warning: Do not use more than two layers of gauze between
the 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. You may continue your
treatment as prescribed by your doctor.

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 Home User’s Guide P/N 507939 rev G 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 your 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 your Home

Therapies Nurse.

If additional information exists for an alarm or warning, the Help screen­button will flash in the bottom right corner of the touch screen. Your
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 your treatment and a table explaining the different WetAlert
Drop icon states.

14 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

Message Meaning Action Required

Press 0 to
disable
Wetness
Detector

Touch
Wetness
Detector

Wetness
Detected

Wetness
Low Battery

The WetAlert device has
alarmed three times in
ten minutes.

The WetAlert device
needs to be activated at
this time.

The WetAlert device has
sensed wetness.

The WetAlert device’s
battery is almost empty.

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 your machine. It will not sense wetness until
reactivated with a new treatment.

Touch the WetAlert device’s metal sensor on the
underside then 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 RESET key to clear the alarm.
Replace the failing WetAlert device before your
next treatment.

Wetness
No Comm.

The machine has
temporarily lost contact
with the WetAlert device.

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 your machine. It
will not sense wetness until reactivated with a
new treatment.

Wetness
Not Active

The machine has lost
contact with the WetAlert
device.

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.

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

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 15

Restarting a Treatment

If your WetAlert device cannot be linked to your machine after repeated
tries, another troubleshooting step is to reset your entire treatment before
blood is sensed and the Tx Clock is started. Contact your Home
Therapies Nurse before attempting this procedure.

To restart your 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 your
parameters. You will be prompted to link a WetAlert device again at the
end of the setup process.

16 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

Reading Drop Icon Status

The Drop icon in the Dialogue Box indicates whether or not your
WetAlert device is ready for your 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. Your machine will display “Touch Wetness
Detector” in the Dialogue Box when entering the “Tx

Gray

WetAlert

device not yet

activated

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
activated

treatment.

The enabled WetAlert devices 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 enabled WetAlert devices 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 Home User’s Guide P/N 507939 rev G 17

After Treatment

WetAlert Device Care

Your WetAlert device should be cleaned after every treatment.
WetAlert devices 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

WetAlert Device Storage

device is essential.

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

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 device 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 Home User’s Guide P/N 507939 rev G

Appendix

WetAlert Spare Parts

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

WetAlert Device Disposal

The WetAlert device is not intended for use beyond the life of its battery.
Disinfect your 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.

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 19

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 institutional environments, such as hospitals

(1)

. 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

(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

(2)

when used in the home.

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.

20 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

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.

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 21

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

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

IEC 60601
test level

3 Vrms

150 kHz to
80 MHz

3 V/m

80 MHz to

2.5 GHz

Compliance
level

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,
less than the compliance level in each
frequency range.

b

a

should be

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

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 re-orienting 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.

22 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

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 Renal Therapies Fresenius Renal Therapies

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

Manufactured by
Fresenius Renal Therapies

920 Winter Street
Waltham, MA 02451

WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G 23

24 WetAlert Wireless Wetness Detector Home User’s Guide P/N 507939 rev G

Indications for Use: The WetAlert wireless wetness detector is indicated for use with the 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.

Note: 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.

Fresenius Renal Technologies
A division of Fresenius Medical Care North America
920 Winter Street
Waltham, MA 02451

For all inquiries and questions,
please contact Technical Services at 1-800-227-2572

P/N 507939