Alfred SmartBag 430 User manual

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User Manual
FPL-2P08-02
SmartBag System Model 430
July 9, 2020

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Contents
Indications For Use....................................................................................................................................... 3
Safety And Warnings.................................................................................................................................... 4
Components Of The SmartBag System........................................................................................................ 5
Instructions For Use ..................................................................................................................................... 6
Register The SmartBag System ................................................................................................................. 6
Preparing And Wearing Your SmartBag.................................................................................................... 6
Emptying Your SmartBag .......................................................................................................................... 7
Removing Your SmartBag ......................................................................................................................... 7
Cleaning and Maintenance .......................................................................................................................... 8
General Cleaning Directions ..................................................................................................................... 8
General Maintenance ............................................................................................................................... 8
Troubleshooting ........................................................................................................................................... 9
Specifications and Symbols........................................................................................................................10
Electromagnetic Conformity Declaration ..................................................................................................12

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Indications For Use
SmartBag’s intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11
Health’s care management platform known as alfred: SmartCare, designed for patients and medical
professionals. The alfred: SmartBag System (including the SmartBag and SmartWafer), offers a continuous
ostomy monitoring system and tracks the estimated volumetric filling of the bag using integrated sensor
technology.
The SmartBag System is for adult use only (22 years and above).

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Safety And Warnings
Note to personnel who provide training to lay operators (i.e. patients) or lay responsible organizations:
Be sure to include all the warnings below when providing training to lay operators, especially in a Home
Care Environment in order to ensure the best device performance. Lay users should be instructed to
contact Technical Support if there is a change in the performance of the SmartBag System. Lay operators
should be instructed on inappropriate environments for use (i.e. shower, MRI environment) for the
system. For guidance on training, please contact Technical Support.
-The patient is an intended operator of the SmartBag System.
-HANDLE SMARTBAG SYSTEM WITH CARE.
-Keep away from pets and children as the SmartBag System is not a toy.
-SmartBag System is not designed to be waterproof. Showering or swimming may affect its
function.
-Do not submerge in water.
-Do not store in direct sunlight.
-Keep clean of excessive dust or lint.
-Do not use microwave to heat the SmartWafer.
-Do not bend the SmartBag or SmartWafer.
-Place mobile phone on airplane mode prior to an airplane flight.
-Stop using the SmartBag System if peristomal skin or surrounding skin begins to experience
irritation.
-Stop using if you experience an allergic reaction to using the SmartBag System.
-Stop using if you notice the hydrocolloid around your stoma sticking to the bag and replace the
whole SmartBag System.
-Do not remove or replace any of the batteries in the SmartBag System.
-Do not tamper or modify any components of the SmartBag System as it may result in inaccurate
readings.
-Do not use outside accessories that are not described in the manual as they may interfere with
the performance and accuracy of the SmartBag System (i.e. sensor detection, EMC performance).
-Remove SmartBag System before entering a magnetic resonance environment (i.e. MRI) as this
type of environment may interfere with the performance and accuracy of the SmartBag System.
-Devices of known electromagnetic interference (EMI) may interfere with the performance and
accuracy of the SmartBag System.
-Avoid use of other equipment that may cause erratic operation or degradation in the performance
of this device due to uncontrolled electromagnetic interference.
Contraindications
-Do not wear if you have electronic implants, such as pacemakers.
-Do not wear if you require a convex wafer as the SmartBag System only works with the
SmartWafer, which is flat.

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Components Of The SmartBag System
1. SmartWafer (SmartBaseplate):
Operator and/or patient should replace the single-use SmartWafer on average every 2-3 days.
2. SmartBag:
Operator and/or patient should replace the single-use SmartBag on average every 2-3 days.

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Instructions For Use
Register The SmartBag System
1. Search for alfred: SmartCare from the App Store/Google Play to download and register.
2. Scan the code on the SmartBag System box to register your kit.
Preparing And Wearing Your SmartBag
1. Clean and dry the stoma and the surrounding skin.
2. Cut the SmartWafer to your stoma size according to the provided guideline and apply onto skin.
3. Roll up the drain tab of the SmartBag prior to wear and firmly press
closed for 5 seconds.
4. Attach your SmartBag to the SmartWafer. Make sure the coupling
mechanism is fully clicked closed.
-Tip: To ease application, you can click the SmartBag and SmartWafer together before applying
onto skin

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Emptying Your SmartBag
1. Undo the hook and loop at the bottom of your SmartBag, pinch in the edges, and empty the contents
into the toilet.
2. Clean outlet with toilet paper or wet wipe.
3. Close outlet by folding the bottom upwards 3 times. On the final fold, firmly press the long hook and
loop flap together to seal the bag.
Removing Your SmartBag
1. Empty your SmartBag.
2. Remove SmartBag by pulling away from the SmartWafer using the belt tab of the coupling system.
Gently remove SmartWafer by pulling from top to bottom.
-Tip: Use one hand to hold the abdominal skin taut by applying gentle pressure, while using the
second hand to gently pull off the wafer.
3. Dispose of the SmartBag and SmartWafer into the trash/bin after wrapping or placing in a disposable
bag.

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Cleaning and Maintenance
General Cleaning Directions
-As the SmartBag and SmartWafer are single use products, little to no cleaning is required as the
SmartWafer is meant to be kept dry
-SmartBag may be cleaned at the drain tab while emptying bag by using a piece of toilet
paper or wet wipe. Option to use water to rinse out SmartBag depending on operator
and/or patient preference
-SmartWafer is not meant to be cleaned as once SmartWafer is stuck onto the skin, it
should be kept dry to prevent unnecessary absorption of liquid
General Maintenance
-Keep the SmartBag and SmartWafer dry during storage

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Troubleshooting
If there are issues seeing data on the SmartCare App, here are a couple step to follow:
-Ensure the mobile application is connected to your Wi-Fi or on cellular data to communicate with
the 11 Health Cloud
-Ensure that Bluetooth is enabled on your mobile device to pair with the SmartBag System
-Ensure the mobile device is within 10 feet of the SmartBag System
-Check the SmartCare App for the SmartBag System status to ensure the components are
connected
-Restart the SmartCare App on mobile device
-Log off SmartCare App on mobile device and log back in
For more questions, please refer to the FAQs that are listed at www.11.health.
For more assistance or questions, please contact 11 Health Technical Support at support-
[e-mail].

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Specifications and Symbols
Specifications
Dimensions
SmartBag – 13.59 cm (5.35”) W x 26.42 cm
(10.40”) L with 4.25cm (1.67”) diameter
opening
SmartWafer – 12.4cm (4.88”) x 12.4cm (4.88”)
with 42mm (15/8”) maximum cut ring
Specified Capacity
350mL
Overfill Capacity
500mL
Volumetric Fill Measurement Accuracy
+/-100mL of volumetric fill
Weight
SmartBag – 1oz/27g
SmartWafer – 0.7oz/20g
Material
SmartBag – EVA, non-woven PE
SmartWafer – Hydrocolloid, PE foam
Power
SmartBag/SmartWafer– Lithium coin cell 3V
225mAh
Communication Method
BLE Module
SmartBag System Service Life
SmartBag – 7 days
SmartWafer – 7 days
SmartBag System Shelf Life
SmartBag – 8 months
SmartWafer – 8 months
Operating Environment
-10° - 42°C (14°- 107°F); 10-85% R.H.; 700-
1060hPa
Storage Temperature
-10° - 32°C (14°- 91°F); 10-90% R.H.; 500-
1060hPa
Operating Temperature
-10° - 50°C (14°- 122°F); 10-90% R.H.; 500-
1060hPa
Type of Protection Against Electrical Shock
Double-insulated
Type Classification
BF Type
IP rating
IP22

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Symbols
Latex free
/
Manufacturing date / Batch Code
Single use only
Manufacturer
Caution: consult
accompanying
documents
Instructions for use attached to the
product
Follow instructions for
use
Type BF applied part
Keep dry
Do not use if package is damaged
Storage temperature
limit
Class II equipment (degree of
protection against electrical
shock), double insulated
Storage humidity limit
Non-ionizing electromagnetic
radiation
Storage atmospheric
limit
Degree of protection against
ingress of particulates >12.5 mm
and ingress from dripping water

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Electromagnetic Conformity Declaration
The SmartBag System (model 430) has been built and tested according to IEC60601-1-2 and United States
Federal Communications Commission (FCC) standards.
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.
The SmartBag System is intended for use in the electromagnetic environment specified below. The
operator and/or patient should assure that it is used in such an environment.
Basic Standards
Test Result
Electromagnetic Environment Guidance
Emissions Testing IEC 60601-1-2
CISPR 11, Radiated Emissions
Compliant –
Class B
The SmartBag System 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.
CISPR 11, Conducted Emissions
NT1
IEC 61000-3-2, Harmonic Current
NT1
IEC 61000-3-3, Voltage Fluctuation &
Flicker
NT
1
Immunity Testing as Referenced in IEC 60601-1-2
IEC 61000-4-2, Electro-Static Discharge
Compliant
IEC 61000-4-3, Radiated Immunity
Compliant
IEC 61000-4-4, Electric Fast Transients
Immunity
NT
1
IEC 61000-4-5, Surges Immunity
NT1
IEC 61000-4-6, Conducted Immunity
NT1
IEC 61000-4-8, Power Frequency
Magnetic Field Immunity
Compliant
IEC 61000-4-11, Voltage Dips &
Interruptions
NT
1
NT1– EUT is battery only and therefore required no AC power to test.

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Recommended separation distances between portable and mobile RF communications equipment
and the SmartBag System
The SmartBag System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SmartBag System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and th
e SmartBag System as recommended below,
according to the maximum output power of the communications equipment.
WARNING: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
SmartBag System, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 Hz
d=1,17√
80 MHz to 800 MHz
d=1,17√
800 MHz to 2,5 GHz
d=2,33√
0,01
0,12
0,12
0,23
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,70
3,70
7,37
100
11,70
11,70
23,30
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din 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.
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.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The SmartBag System is intended for use in the electromagnetic environment specified below. The
customer or the user of the SmartBag System 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
3Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 6 GHz
27 V/m
NT
Complies
Portable and mobile RF communications
equipment should be used no closer to
any part of the SmartBag System
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.

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385 MHz
28 V/m
450 MHz
9 V/m
710/745/780 MHz
28 V/m
810/870/930 MHz
28 V/m
1720/1845/1970
MHz
28 V/m
2450 MHz
9 V/m
5240/5500/5785
MHz
Recommended separation distance
d=1,17√
d=1,17√80 MHz to 800 MHz
d=2,33√ 800MHz to 2,7 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and dis the recommended
separation distance in metres (m).
The SmartBag System is fairly sensitive to
conducted and radiated RF. Disturbance
of the SmartBag System trace is possible
at and below the specified test level. It
may be necessary to relocate the
SmartBag System or to apply shielding.
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,ashould be
less than the compliance level in each
frequency range. b
Interference may
occur in the vicinity of equipment
marked with the following symbol:
Note 1 At 80 MHz and 800MHz, 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 SmartBag System is used exceeds the
applicable RF compliance level above, the SmartBag System should be observed to verify
no
rmal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the SmartBag System.
b) Over the frequency range 80MHz to 6GHz, field strength should be less than 3V/m.

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11 Health and Technologies Inc.
8 Hughes Suite 200
Irvine, CA 92618 USA