Claris Healthcare REFLEX1 Claris Reflex User Manual Claris Reflex IFU CQ1 PS2

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Document ID	3793146
Application ID	WDu+xnho1Jf8od++A9UbDw==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	29.33kB (366576 bits)
Date Submitted	2018-03-23 00:00:00
Date Available	2018-03-23 00:00:00
Creation Date	2018-02-09 12:00:27
Producing Software	Microsoft: Print To PDF
Document Lastmod	2018-02-09 12:00:27
Document Title	Microsoft Word - Claris-Reflex IFU-CQ1-PS2
Document Author:	Curtis

Knee Rehabilitation System
Instructions for Use
© 2018 Claris Healthcare Inc.
Claris Reflex® is a registered trademark of Claris Healthcare
Notes
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 1
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 10
Notes
PACKAGE CONTENTS








1 – Claris Reflex Sensor
1 – Tablet with Case, AC power adapter & USB charging cable
8 – Small Adhesive Pads
8 – Large Adhesive Pads
8 – Alcohol Wipes
6 – Adhesive Remover Wipes
1 – Quick Start Guide & Exploring your Reflex Screen Guide
1 – How to Prepare & Attach Sensor Guide
CONTACT INFORMATION
To obtain additional information or if you have questions regarding your
system, please see the Troubleshooting FAQs below or contact Claris
Customer Support at 1-844-369-9977 ext 2 or visit www.clarisreflex.com.
PRODUCT DESCRIPTION
SYSTEM OVERVIEW
Claris Reflex is a Knee Rehabilitation System, designed to be used by
patients undergoing joint arthroplasty surgery, under the guidance of
trained medical professionals. The system is a combination of a tablet,
computer software and electronic sensors, that measure the patient’s
body position, frequency of motion and approximate range of motion of
the effected joint, and the temperature near the surgical site for the
purposes of detecting icing.
The software receives data from the sensors displays the data to the
patient and to trained medical professionals, so that they may interpret
the data to determine the degree of compliance by the patient, to their
prescribed joint rehabilitation regimen.
Claris Reflex is not intended to diagnose, treat, prevent, cure or mitigate
any disease or condition; it is intended only to measure and display the
results.
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 9
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 2
WARNINGS & SAFETY PRECAUTIONS
PRODUCT SPECIFICATIONS
Read all the information in this Guide and other
provided instructions before operating the system.
Do not expose sensor to water. Remove sensor prior to
bathing, showering, or swimming.
Do not attempt to disassemble or change the battery.
This device meets FCC and IC regulations if used as
specified. See last page for details.
Consult your physician for any of the following
situations:
a. Allergic reaction to the adhesive pads including any skin
redness or inflammation
b. Simultaneous use with other medical monitoring or bracing
equipment on the same limb
FCC Part 15
USING YOUR CLARIS REFLEX SYSTEM
1.
2.
3.
4.
5.
Read through and follow the Quick Start Guide to power on your
Claris Reflex tablet.
Familiarize yourself with the Exploring your Claris Reflex
Screen Guide .
When it’s time, your tablet will automatically prompt you to
attach your sensor to the side of your knee. At that time, follow
the When it’s Time to Attach your Sensor instructions.
You can review the above information and other instructional
videos at any time by pressing the Resources button on your
Claris Reflex tablet screen.
If you have any trouble with your Claris Reflex, please review
the TROUBLESHOOTING FAQs section below or see the
CONTACT INFORMATION section above.
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 3
This device complies with FCC Rules Part 15 operation is subject to the following two
conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference, including interference that may cause
undesired operation of the device.
Changes or modifications to this device, not expressly approved by Claris, could void
the user’s authority to operate the equipment.
2AOOK-REFLEX1
Industry Canada Notifications
This device complies with Industry Canada’s license-exempt RSSs. Operation is
subject to the following two conditions:
(1) This device may not cause interference; and
(2) This device must accept any interference, including interference that may cause
undesired operation of the device.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux
appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions
suivantes:
(1) l’appareil ne doit pas produire de brouillage;
(2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si
le brouillage est susceptible d’en compromettre le fonctionnement.
IC: 23491-REFLEX1
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 8
How do I use Claris Reflex to communicate with my care team?
TROUBLESHOOTING FAQS
You can use Claris Reflex as an easy way to communicate with your care
team:
My tablet won’t turn on.
1. To send them a message, press Activities and then Messages.
2. On the Messages page, you can select Write to write new
messages, or Read to read old messages.
3. If you press Write, you will see a list of members of your care
team.
4. Select the person you wish to contact and use the on-screen
keyboard to write your message.
5. You can attach a photo to your message by pressing Take Photo
and using the tablet’s camera to take a photo. Note - Once you
have taken the photo, you’ll need to press the checkmark on the
right side of the screen to return to your message.
6. Instead of using the on-screen keyboard, you can also select
from a list of preset phrases by pressing on Quick Text.
7. When you are done writing a message, press Send.
8. You can reply to messages by pressing the Reply button while
reading an old message.
9. You can review your old messages by pressing the Next and
Back buttons.
10. When you are done, press Close to take you back to the Claris
Reflex home screen.
1.
Ensure you press and hold down on the power button for at least
4 seconds (button above the purple dot).
2. The battery on the tablet may be dead:
 Ensure the charging cable is pressed into the side of the
tablet and the charger is plugged into a power outlet.
 If your tablet is powered off, when it first starts charging, it
will display a battery icon on the screen with a percentage
indicating how much the battery has charged.
 Once the battery has reached at least 5%, turn the tablet on
using the power button above the purple dot.
 We highly recommend that you keep the tablet plugged in at
all times to ensure that the battery does not go dead.
I am having trouble calibrating my sensor.
To calibrate your sensor:
1.
2.
If I missed one of my scheduled Activities, can I still complete it?
The scheduled times for your Daily Activities are just a
recommendation by your care team. You can complete any of your daily
tasks at your convenience. As long as the Activities button is displayed
with a solid blue background, it means that they are still available to be
completed. Activities buttons with a grey background have already
been completed.
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 7
3.
4.
5.
Press the Activities button on the tablet home screen and then
press Calibrate Sensor
We recommend that you enter your flex and extension values. If
you do not know your values, please ask your case manager or
physical therapist to measure your values and write them down
for you during your next appointment.
You can also estimate your flexion and extension values by
pressing Resources and viewing the Calibrating Sensor
information.
If you see an error message saying that the sensor is not
connected, proceed to the next section of this guide titled “What
does it mean if my sensor is disconnected? ”
If you experience any other problems while calibrating your
sensor, please contact your case manager.
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 4
What does it mean if my sensor is disconnected?
I am on the Icing page, but the timer won’t start.
On the home screen of your tablet:
The Icing timer starts once the sensor detects that the temperature of
your knee is below a temperature set by your care team. The timer will
start counting once the temperature reading is between the two
triangles below the thermometer.
1.
2.
3.
4.
5.
6.
7.
If the dot on the top left of your home screen (to the left of Day X)
is Green your Claris Reflex sensor is connected to the tablet.
If the dot is Orange, the sensor is connected to the tablet, but is
not properly attached to the adhesive pads so it isn’t sending any
data. Disconnect the sensor from the adhesive pads on your leg,
then reconnect the sensor by firmly pressing the sensor onto the
adhesive pads.
If the dot is still Orange, disconnect the sensor from the
adhesive pads on your leg and use a new set of adhesive pads
from your Claris Reflex box.
Without applying the new adhesive pads to your leg, snap the
sensor onto the new adhesive pads and check the colored dot on
the home screen again.
If the dot turns Green, you will need to replace the adhesive
pads on your leg with the new ones from your Claris Reflex box.
If the dot is still not Green, please contact your case manager.
If the dot is Red and you are currently wearing your Claris
Reflex sensor, please contact your case manager.
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 5
How do I keep track of my pain medications?
To record a medication and view your medications log:
1.
2.
3.
4.
5.
6.
On the tablet home screen, press on Activities and then
Medication.
If you have not already setup a medication, then you will need to
press Setup Medication and then Add Medication.
On the Add Medication screen, type the name of the medication
you wish to add and click Done.
Repeat this process until you have added all your medications.
To record your medications, press Take Medication and select
the medication from your list of medications.
A log of your medications will be displayed to the right of the
Take Medications button. If you’d like to review the previous
day’s medications, press the Previous button.
800-004-01-90 | Claris Healthcare | 1-844-369-9977 ext2 | support@clarisreflex.com | Page 6

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