Rooti Labs M2-2016 Rooti RX User Manual InstructionManual revJ 20160307
Rooti Labs Limited Rooti RX InstructionManual revJ 20160307
User manual
ECG Event Recorder
Instruction Manual
Rooti Labs Limited
5F-1, No.71, Zhouzi St., Neihu Dist.,
Taipei City 114, Taiwan (R.O.C.)
Tel: +886 (2) 2656-0618
E-mail: service@rootilabs.com
https://www.rootilabs.com/
Authorised Representative in the European community
User Manual V1.0
0598 0560
EC REP
Wellkang Ltd (www.CE-marking.eu)
29 Harley St., London W1G 9QR, UK
1
TABLE OF CONTENTS
BEFORE USE
Introduction
Product Description
Safety Information
Icon Explanation
Operating the Rooti Rx
Care and Maintenance
Before Taking a Measurement
OPERATION INSTRUCTIONS
Rooti Rx
Components
Rooti Link
Instruction Manual
Features
Applications
Getting Started
LED Indications
Troubleshooting
Specification
FCC Statement
1
1
1
1
2
2
3
4
4
4
5
5
6
6
6
7
12
12
13
15
Introduction
Thank you for purchasing the Rooti Rx.
Product Description
The Rooti Rx is a compact physiological monitoring module. The
intended use of Rooti Rx is to provide a facility in the home, workplace
and for recording and transmitting single lead EGG data to a qualified
receiving station for interpretation by medical professionals. The Rooti
Rx stores one lead electrocardiography(ECG) signals and recording data
transmission via WiFi.
To interpret recording data should be skilled at the level of a technician,
doctor, nurse, or medical specialist.
The Rooti Rx comes with the following components:
•Rooti Rx •Charging Dock •Electrode Sticker x3
•Instruction Manual
Safety Information
To assure the correct use of the product basic safety measures
should always be followed including the warnings and cautions
listed in this instruction manual.
Please read this instruction manual
thoroughly before using the unit.
Please keep for future reference.
BEFORE USE
Fill in for future reference
DATE PURCHASED:
SERIAL NUMBER:
• Staple your purchase receipt here
2 3
Operating The Rooti Rx
Read all of the information in the instruction manual and any other
literature in the box before operating the unit.
Subjects fitted with a heart pacemaker should not use the Rooti Rx.
The Rooti Rx should not be used in conjunction with any defibrilla-
tor, including implanted or AED devices.
Please use standard USB power outlet. The USB power outlet must
be certified to IEC/EN 60601-1 for 2 MOPP and examined regularly.
When wearing the Rooti Rx to shower, RED LED flashes temporarily.
Wipe dry the Rooti Rx after shower, RED LED stops flashing. If RED LED
still flashes, please change new Electrode Pads.
If LED continues flashing after all these steps or user has any other
problem, please CONSULT DOCTOR.
0598
-10
60
EC REP
IP58
SNLOT
Icon Explanation
Do not reuse
Temperature limitation
Read this instruction manual
thoroughly before using the
unit.
Type BF applied part
Authorised representative in
the European Community
Battery must be recycled
Batch Code
Manufacturer
Date of Manufacture
CE Certificate
0560
RF CE Certificate
Use By
Ingress Protection
5:Dust Protected
8:Protected against the effects of
temporary immersion in water
Direct Current
Serial Number
Caution:
Indicates a potentially hazardous situation
which, if not avoided, may result in minor or
moderate injury to the user or patient or
damage to the equipment or other property.
If user feels itchy and allergic after the electrode sticker long-time
attached to skin, please remove the sticker and ask users to CONSULT
DOCTOR.
We advise pregnant women and children to use this product under
the supervision of a doctor.
No modification of this equipment is allowed.
Be aware of choking resulting from a child swallowing a small part
that has become detached from Rooti Rx.
Care And Maintenance
Operate the Rooti Rx only as intended. Do not use the Rooti Rx for
any other purpose.
Do not submerge the Rooti Rx or any of the components in water.
Do not wear Rooti Rx to swimming or taking a bath.
Store the Rooti Rx and the components in a clean, safe location.
(-10~60 C / 10~95% R.H. (noncondensing))
Ingress Protection
5:Dust Protected
8:Protected against the effects of temporary immersion in water
The conductive parts of electrodes and associated connectors for
type BF or CF applied parts, including neutral electrode, should not
contact other conductive parts including earth.
The disposal of Rooti Rx and accessories follows normal electronic
waste recycling method.
Side Effect
If long time wearing Rooti Rx, users may feel itchy and a little bit
allergic on skin.
Contraindication
following patient must be follow the doctor's instructions to use:
1. Chronic Disease patients
2. Allergic to Polyester patient
3. Pregnant woman
4. Children
5. Breastfeeding women
4 5
Compatibility
•iOS 8+
•iPhone 5+
•iPad Mini
•iPad 3+
Before Taking a Measurement
To ensure a reliable measurement, follow these recommendations:
- We suggest using alcohol pad to clean the back of Rooti Rx (Sensor
Pad) before and after use.
- During recording, please do not take off the Rooti Rx.
- Electrode Sticker is only for ONE time use. Please change a new
sticker every time before use.
- When wearing the Rooti Rx to shower, RED LED flashes temporarily.
Wipe dry the Rooti Rx after shower, RED LED stops flashing. If RED LED
still flashes, please change new monitoring electrodes. If LED continues
flashing after all these steps or user has any other problem, please
CONSULT DOCTOR.
- Please make sure to put the Rooti Rx onto the Charging Dock before
data downloading.
To have a better using experience, read the following items.
- Quick RED LED flashing indicates LOW POWER while slow RED LED
flashing indicates LEAD OFF.
- When connecting to Rooti Rx, users cannot use the internet at the
same time.
- If user feels itchy and allergic after the electrode sticker long-time
attached to skin, please remove the sticker and ask users to CONSULT
DOCTOR.
Rooti Rx has to be worked along with App “Rooti Link”. Download
“Rooti Link” in Apple Store and follow the on-screen instruction to set
up the Rooti Rx.
Components:
OPERATION INSTRUCTIONS
Front
Rooti Rx
Front Back
Charging Dock
Electrode Sticker
Rooti Link
Back
Sensor
Pad
LED
Function
Button
Notice: We suggest using ALCOHOL PAD to clean the
back of Rooti Rx (Sensor Pad) before and after use.
Double-sided tape
(attach to Rooti Rx)
Snap
Snap (Snap with self-prepared
Monitoring Electrodes)
Double-sided tape
(attach to user’s skin)
USB
Charger Dock
Transmit to Mobile Device Application
6 7
1. Inside the box
Rooti Rx x1
Electrode Sticker pack x3
Charging Dock x1
Instruction Manual x1
2. Charge Rooti Rx
Put the Rooti Rx into Charging Dock and plug it into power outlet,
meanwhile, Green LED flashes. When full-charged
the Rooti Rx, LED lights out.
3. Download RootiLink App for your
patient
First, help your patient to set up
RootiLink, the app for Rooti Rx. Ensure
smart device is connected to Internet and
search for “RootiLink” in App Store, down-
load and set up a RootiLink account for
your patient.
(1) After downloaded,
start RootiLink.
(2) Sign up a new account
for RootiLink, set up your
personal profile.
Features
- ECG (EC38 Type 3)
- Skin Temperature
- Uses Standard ECG Electrodes
- Wi-Fi data download
- Rechargeable
- USB charging
- Red/ Green/ Blue LED
- Function button
- IP58
Applications
- Hospital General Care
- Skilled Nursing Facilities
- Home based Remote Patient Monitoring
- Physiological status monitoring in real world situations
Getting Started
Manual
*ATTENTION: To achieve maximum
product utility, please make sure to
fully charge the Rooti Rx before
use.
Instruction Manual
ECG Event Recorder
Instruction Manual
89
4. Offer Rooti Rx as a Tool for Your Patients
Follow the instructions in the app, set up Rooti Rx for your patients
and start recording.
(1) Step 1: Remove double-sided tape in the front side of Eletrode
Sticker.
(2) Step 2: Stick the Rooti Rx onto the FRONT of Electrode Sticker.
Aim the circle steel dot to the hole of sticker.
(3) Step 3: Snap in Monitoring Electrodes to Electrode Sticker.
(4) Step 4: Remove adhesive tapes on the BACK of Electrode Sticker.
(5) Step 5: Ask patients to stand still, chin
up and chest out. Attach Rooti Rx on top of
patients’ left chest. Make sure the sticker
can cover on skin properly without abnormal
stretching or twisting. (Approximately 3cm
upper from left nipple.)
*ATTENTION:
a. Please use certificated self-prepared standard Monitoring
Electrodes sold in general pharmacy.
b. During the recording, teach patients to short press the button
when they feel uncomfortable, and Rooti Rx will record ECG tags.
12 3 45
(3) Tap “Device Set Up” in main page.
(4) Follow the instructions in the app and connect RootiLink with
Rooti Rx.
Notice: After connecting Wi-fi in Apple system, quickly press Home
key twice to go back RootiLink.
*a
Chest out when
attach Rooti RX
10 11
c. If Rooti Rx leads off or not attaches well to your body, Red LED will
keep lighting up. Please go back to hospital for medical support.
5. Preview mode
After set up Rooti Rx, check the patients’ ECG signal/ skin tempera-
ture through Preview mode of RootiLink. Make sure the ECG signal is
stable and well-performed.
6. Set up recording days and countdown timer starts
counting.
At this time, Rooti Rx will work as a standalone recorder.
7. Review Record for Your Patients
After recording, help your patients to download their record in the
app. Review history ECG data as your further diagnose references.
(3) Follow the on-screen instruction
in the app. Long press the Rooti Rx
function button and activate Wi-Fi
advertising (BLUE LED) to recon-
nect Rooti Rx with RootiLink.
(4) Tap “Download” and put the Rooti Rx into Charging Dock. Plug
into power through USB charger.
Short press to tag
(1) Reopen RootiLink. (2) Remove electrode sticker
from the Rooti Rx.
(5) During the download, Rooti
Rx flashes Blue LEDs quickly.
(6) When download completed,
you can review ECG Tag or ECG
Date in History Data.
12 13
LED Indications
Specification
Troubleshooting
When short press the Rooti Rx, it indicates Red LED.
Please charge the Rooti Rx by plugging into the Charging Dock.
When connecting my phone with the Rooti Rx, why it stucks
in the Wi-Fi searching list?
iOS: Press “Home Key” twice to go back RootiLink
Why is Rooti Rx keeps flashing RED?
Rooti Rx is LOW BATTERY, please CONSULT DOCTOR/
MEDICAL PROFESSIONALS.
Rooti Rx is in LEAD OFF status
1. Please adjust Monitoring Electrodes and Electrode Sticker, see if
they are finely attached.
2. If 1. cannot solve the problem, change new Monitoring Electrodes.
3. If 1. & 2. are not available to solve this problem, please CONSULT
DOCTOR/ MEDICAL PROFESSIONALS.
I am charging the Rooti Rx, it’s originally lightening GREEN,
but it’s now no LED signal.
Rooti Rx is now fully battery charged.
0~40 C
20~93 %R.H.
80,0 kPa to 101,3 kPa
(noncondensing)
Brand
Model
Item
Measurement Method
Rating
Power Source
Battery Life
Operating Environment
Storage and transportation
Environment
Record mode
Environment
Charging mode
and others
Main Unit Weight
Dimensions for Main Unit
Accessory
Rooti
Rooti Rx
Rooti Rx
One Lead Electrocardiogram, EKG/ECG
Direct Current 3.7v 250 mAh
Lithium-ion Polymer
Battery Pack 250 mAh AHB521630
2 year or 500 times
Expected Service Life: 1 year
14 g ± 1 g
62 * 22.5 * 8.45 mm
Charging dock, Electrode sticker
0~50 C
20~93 %R.H.
80,0 kPa to 101,3 kPa
(noncondensing)
-10~60 C / 10~95 %R.H.(noncondensing)
Rooti Rx
Battery Low
Lead Off
Record ECG tags N/A
Pairing:
Uploading:
Battery Check: full
Battery Check: Low
Charging:
Finish Charging: N/A
On Body
Off Body
On Base
Short Press
Long Press
14 15
Brand
Model
Item
Operating Environment
Storage and transportation
Environment
Main Unit Weight
Dimensions for Main Unit
Rooti
Rooti Rx
Charging Dock
18 g
64 * 30 * 7 mm
-10~60 C / 10~95 %R.H.(noncondensing)
0~50 C / 20~93 %R.H.
Atmospheric pressure 80,0 kPa to 101,3 kPa
(noncondensing)
Charging Dock
Brand
Model
Item
Operating Environment
Storage and transportation
Environment
Main Unit Weight
Dimensions for Main Unit
Rooti
Rooti Rx
Electrode Sticker
0~50 C / 20~93 %R.H.
Atmospheric pressure 80,0 kPa to 101,3 kPa
(noncondensing)
3.2 g
32.7 * 115 * 5.2 mm
Electrode Sticker
-10~60 C / 10~95 %R.H.(noncondensing)
Federal Communications Commission (FCC) Statement
(1) 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 of the device.
(2) You are cautioned that changes or modifications not expressly approved by the part responsi-
ble for compliance could void the user’s authority to operate the equipment.
(3) 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.
FCC RF Exposure:
“For body worn operation, this Rooti RX has been tested and meets FCC RF exposure guidelines
when used with an accessory that contains no metal and that positions the Rooti RX a minimum
of **5mm** from the body. Use of other accessories may not ensure compliance with FCC RF
exposure guidelines.”
To comply with the FCC RF exposure compliance requirements, this device and its antenna must
not be co-located or operating in conjunction with any other antenna or transmitter.
European Union Regulatory Notice
This device bearing the CE marking is in compliance with the essential requirements and other
relevant provisions of Directive : 1999/5/EC. This device complies with the following harmonized
European standards.
Radio: ETSI EN 300 328 V1.9.1 : 2015 / BS EN 62479 : 2010
EMC: EN 301 489 –1 v1.9.2: 2011 / EN 301 489 –17 v2.2.1: 2012
EN 55022: 2010+AC: 2011
EN61000-3-2 : 2006+A1:2009+A2:2009 / EN61000-3-3 : 2008
EN 61000-4-2 : 2009 / EN 61000-4-5 : 2006
EN 61000-4-3 : 2006+A1:2008+A2:2010 / EN 61000-4-6 : 2014
EN 61000-4-4 : 2012 / EN 61000-4-11 : 2004
Safety : EN 60950-1: 2006+A11: 2009+A1: 2010+A12: 2011+A2: 2013
©2016 Rooti Labs Limited. All rights reserved. Reproduction in whole or in part is prohibited.
Rooti and Rx are trademarks of Rooti Labs Limited, applied in the U.S. and other countries.
Service Life Expected Service Life: 1 year
16 17
The Rooti RX is intended for use in the electromagnetic environment specified below.
The customer or the user of the Rooti RX should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
/flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
The Rooti RX uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
The Rooti RX is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Compliance
Guidance and manufacturer’s declaration -electromagnetic emissions
The Rooti RX power frequency
magnetic fields should be at levels
characteristic of a typical location in a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Rooti RX
requires continued operation during
power mains interruptions, it is
recommended that the Rooti RX be
powered from an uninterruptible power
supply or a battery.
The Rooti RX is intended for use in the electromagnetic environment specified below.
The customer or the user of the Rooti RX should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment-guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
+ 6 kV contact
+ 8 kV air
+ 1kV line(s) to line(s)
+ 2kV line(s) to earth
+ 2kV for power
supply lines
+ 1kV for input/
output lines
+ 22kV for power
supply lines
Not applicable
+ 1kV differential
mode Not applicable
+ 6 kV contact
+ 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%
Mains power quality should be that of
a typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
<5% UT(>95% dip
in UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip
in UT) for 5 s
<5% UT(>95% dip
in UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip
in UT) for 5 s
Voltage Dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50, 60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Guidance and manufacturer’s declaration-electromagnetic immunity
NOTE UT is the a.c. mains voltage prior to application of the test level.
The Rooti RX is intended for use in the electromagnetic environment specified below.
The customer or the user of the Rooti RX should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Portable and mobile RF communications
equipment should be used no closer to any part
of the Rooti RX including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P 80MHz to 800 MHz
d = 2,3 √P 800MHz 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 metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, should
be less than the compliance level in each frequency
range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
3 Vrms
150 KHz to 80 MHz
3 V/m
80MHz to 2,5 GHz
3 Vrms
3 V/m
Guidance and manufacturer’s declaration-electromagnetic immunity
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 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 Rooti RX is used
exceeds the applicable RF compliance level above, the Rooti RX should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
the Rooti RX.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
a
Recommended separation distance between
portable and mobile RF communications equipment and the Rooti RX
The Rooti RX is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Rooti RX can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the Rooti RX
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
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
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
metres (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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.