Allergan CS-CB-BLU Bluetooth Patient Call Button Instruction Manual

Allergan CS-CB-BLU Bluetooth Patient Call Button

OVERVIEW

This document provides instructions for use for the Patient Call Button for the CoolSculpting Elite System. Please refer to the user manual for the Intended Use, Contraindications, Warnings, Precautions, Adverse Events, and detailed instructions on how to use and maintain the CoolSculpting Elite System. The Patient Call Button, used with the CoolSculpting Elite system, is a wireless means for the patient to contact the practitioner during a treatment.

WARNING:
Unauthorized changes or modifications not expressly approved by ZELTIQ can void the user’s authority to operate the equipment.

The Patient Call screen allows you to pair the system with a Patient Call Button.
Note: The Patient Call Button goes to sleep after 3 minutes of inactivity when the COOLSCULPTING® ELITE system is powered off. To activate the Patient Call Button, press down on the grey snowflake icon.

To pair a Patient Call Button:

1. From the Tools menu, tap Settings. The Settings menu appears under the Tools menu.
2.  From the Settings menu, tap Patient Call. The Patient Call screen appears.
3.  Press down on the grey snowflake icon on the Patient Call Button to activate it.
4. Tap Scan. When you see your Patient Call Button listed, tap Pair. Confirm that the serial number displayed on the screen matches the Patient Call Button to be used. Remove the blue lanyard to see the serial number on the backside of the white Patient Call Button.

Note: The specific Patient Call Button will highlight blue on the screen when selected. If the button is awake, it will move from paired to connected.
Note: If there is a Patient Call Button already in use, the screen message will request to unpair the paired/connected Patient Call Button first. Follow the steps below within “To disconnect or replace a Patient Call Button or use the same Patient Call Button with a different COOLSCULPTING® ELITE system.”
Note: Only one Patient Call Button can be paired with a COOLSCULPT-ING® ELITE system.

• After pairing, the status will update to connect. The Patient Call Button is now ready for sending notifications.
•  Return to the Tools menu or exit the Tools session:
  Tap Back to return to the Tools menu.
  Tap the close button on the bottom left of the screen to return to the treatment session.

Confirm that the Patient Call Button is ready for sending notifications:

1.  Within the Tools menu, wait until the connection confirmation appears before sending notifications from the Patient Call Button.
2.  Press down on the grey snowflake icon on the Patient Call Button to send a notification. A bell icon on the upper right of the menu bar should illuminate, which can occur remotely. An audible feedback will occur as well.
3.  Tap on the illuminated bell icon to turn it off in order to allow the patient to utilize the Patient Call Button during treatment.

To disconnect or replace a Patient Call Button or use the same Patient Call Button with a different COOLSCULPTING® ELITE system::

1.  From the Tools menu, tap Settings. The Settings menu appears under the Tools menu.
2.  From the Settings menu, tap Patient Call. The Patient Call screen appears.
3.  Confirm that the serial number displayed on the screen matches the Patient Call Button to be disconnected. Tap Unpair.
4.  Follow the above steps “To select a Patient Call Button to pair.”

United States of America:

The Patient Call Button has been tested and found to comply with the limits for a Class A digital device, pursuant to parts 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Operation is subject to the following two conditions:

1.  This device may not cause interference;
2.  This device must accept any interference, including interference that may cause undesired operation of the device.

Note: The blue lanyard covers the side and back of the white Patient Call Button. The blue lanyard strap is for the customer to hold onto during treatment.

Cleaning the Patient Call Button:

1.  Approved cleaning products include:
   A damp towel or water-based wipe
   Isopropyl alcohol
   A mild detergent and warm water
   PDI Sani Cloth Plus wipes

2.  Dampen a towel with a cleaning solution or use a water-based or cleaning solution wipe.

3.  Wipe down the Patient Call Button and the blue lanyard. Do not submerge in water.

Canada:
The Patient Call Button complies with ISED Canada license-exempt RSS standards. Operation is subject to the following two conditions:

1.  This device may not cause interference;
2.  This device must accept any interference, including interference that may cause undesired operation of the device.

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