Fresenius Medical Care DIASAFE 2008 K Manual

2008K Operator’s Manual P/N 507938 Rev. 1 Draft 2 Page 1 of 6
Fresenius USA
2008K Hemodialysis Machine
Operator’s Guide Wireless Wetness Detector
Addendum

Page 2 of 6 P/N 507938 Rev. 1 Draft 2 2008K Operator’s Manual
Wireless Wetness Detector for Patients
The Wireless Wetness Detector is a disposable device that monitors for leaks. It transmits radio
signals to the 2008K hemodialysis machine and alerts the machine when the detector senses a
conductive substance like fluid on its sensors.
When the Wireless Wetness Detector option has been set, a gray Drop icon will be displayed in
the Dialogue Box. The detector is not activated until the icon is green.
Patient Wireless Wetness Detector Setup During Treatment
Proceed with typical treatment setup (as explained in Chapter 2 of the 2008K
Hemodialysis Machine Operator’s Manual P/N 490042), following clinic
instructions. Use these instructions before starting the Tx Clock to activate the
Wireless Wetness Detector.
1. After preparing the patient’s access, create a wetness signal within 10 feet of the
machine by touching the metal pattern on the bottom of the detector for at least 3
seconds (see Figure 1) with a conductive surface. Fresenius Medical Care
recommends using gauze damp with disinfectant to activate it.
Warning! Keep access sites uncovered and monitored. Machine alarms do not
sound in every blood loss situation.
Warning! Do not touch non-sterile objects to the Wireless Wetness Detector
sensor.
Figure 1 – Create Wetness Signal
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2008K Operator’s Manual P/N 507938 Rev. 1 Draft 2 Page 3 of 6
2. The Wireless Wetness Detector will send a wetness signal to the machine. Make
sure that an audible alarm sounds and the Status Bar turns red and displays the
message “Wetness Detected #1” (see Figure 2).
Figure 2 – Home screen: Wetness Detected #1
3. Press the 1key to learn the Wireless Wetness Detector and clear the alarm. The
Drop icon in the Dialogue Box will turn green.
4. Place the detector on the access site bandage and secure it in place with another
bandage. The Wireless Wetness Detector will continue to transmit signals to the
dialysis machine for the next eight hours.
Warning! Place the detector below the access site on top of no more than two
layers of gauze. Failure to do so may allow a blood leak to go undetected.
Undetected blood leaks can cause serious injury or death.
5. Touch the Tx Paused button and press the CONFIRM key. The treatment will
begin counting down. If a “Wetness Detected” alarm occurs, it can be cleared
with the RESET key.
Note: If the machine displays the message “Wetness Detector Not Active”,
the Wireless Wetness Detector must be re-activated by touching the metal pattern
on the bottom of the detector again.
Note:If a “Wetness Detected” alarm occurs three times within 10 minutes, the
Dialogue Box will display the following message: “Press 0 to disable Wetness”
If the 0key is then pressed, its audible alarm will be deactivated. The Drop icon

Page 4 of 6 P/N 507938 Rev. 1 Draft 2 2008K Operator’s Manual
in the Dialogue Box will be yellow to show that a Wireless Wetness Detector is
disabled.
Note: If the machine displays the message “Wet Low Battery #X”, where the
“X” indicates the Wireless Wetness Detector number, that Wireless Wetness
Detector must be replaced.
Note: Pressing the New Tx key and selecting a new treatment, changing the
Blood Sensed status, or running a rinse program will clear Wireless Wetness
Detector #1’s association with the machine. If any of those occur, Wireless
Wetness Detector #1 must be relearned as explained above.
Using additional Wireless Wetness Detectors
Up to three Wireless Wetness Detectors may be linked to one machine. Wireless
Wetness Detectors #2 and #3 must be set in Service Mode and are not patient-
specific.
Setting Wireless Wetness Detector Option in Service Mode
The “Wireless Wetness” option must be selected in Service Mode in order to use any
Wireless Wetness Detectors. Set the Wireless Wetness toggle-button, located in the
“Module Options” tab of the “Hardware Options” tab, to Yes.
Figure 4 – Service Mode: Options: Module Options screen

2008K Operator’s Manual P/N 507938 Rev. 1 Draft 2 Page 5 of 6
Learning Wireless Wetness Detectors #2 and #3 ID’s
Wireless Wetness Detectors 2 and 3 are learned only in Service Mode. They are
machine specific and do not need to be relearned with every new treatment. To set
Wireless Wetness Detectors, go to the “Module Options” screen in Service Mode.
Next touch the Wetness Detector X toggle-button (where X= 2 or 3) to set it from
CLEAR to LEARN, and then press the CONFIRM key. When directed by the Status
Bar, touch the metal pattern on the bottom of the detector and then release it when
indicated. The device’s learned ID will appear in the ID box below the button. You
may set the other detector by touching its corresponding button and activating it as
described above.
Clearing Wireless Wetness Detectors #2 and #3 ID’s
To clear a detector’s association with the machine, touch that detector’s Wireless
Detector toggle-button to set it from LEARN to CLEAR, and then press the
CONFIRM key. The ID box will display “0” and the selected Wireless Wetness
Detector will no longer be linked to the machine.
When Wireless Wetness Detectors 2 and 3 sense wetness during treatment, they act
like Wireless Wetness Detector #1 and may be reset using the RESET key.
Similarly, if the 0key is pressed during a detector’s third alarm, it will disable the
alarming device. That Wireless Wetness Detector must then be relearned in Service
Mode.
Wireless Wetness Detector Care
Wireless Wetness Detectors in contact with patients or fluids should be cleaned after
every treatment. They can be cleaned with very dilute bleach or other suitable
hospital disinfectant. 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 Wireless Wetness Detector is essential.
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Page 6 of 6 P/N 507938 Rev. 1 Draft 2 2008K Operator’s Manual
General Warnings
This device complies 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 has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses and can radiate 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.
Caution: Changing or modifying the Wireless Wetness Detector without the
expressed written consent of Fresenius Medical Care could void the user’s
authority to operate the equipment.
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