Simavita smartz User manual

SIM™ User Manual | Prod Code: 02579_03 | Version: 3a
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Smartz User Manual | Prod Code: 02864_2
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COPYRIGHT INFORMATION
Copyright 2010-2019 Simavita Ltd. All rights reserved.
The information contained in this User Manual is the sole property of Simavita and may not be duplicated
without permission. This User Manual may be revised or replaced by Simavita Ltd at any time and without notice.
Please ensure that you have the latest version of this manual; in case you need help contact Simavita Technical
Support Department.

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Table of Contents
Copyright Information ...............................................................................................................................2
Table of Contents ...............................................................................................................................................3
Preface ............................................................................................................................................................... 4
Purpose of this manual..............................................................................................................................4
Qualification of Personnel ......................................................................................................................... 4
Warranty.................................................................................................................................................... 4
Document Conventions .............................................................................................................................4
1.0 Safety Information .......................................................................................................................................6
1.1 Definitions............................................................................................................................................6
1.2 Warnings.............................................................................................................................................. 7
1.3 Cautions ............................................................................................................................................. 10
1.4 Symbols and markings .......................................................................................................................11
1.5 Labels ............................................................................................................................................... 133
1.6 Disposal..............................................................................................................................................14
2.0 Overview ..................................................................................................................................................166
2.1 What is the SMARTZ system ............................................................................................................ 166
2.4 The SMARTZ technology components............................................................................................... 19
3.0 USER INSTRUCTIONS ................................................................................................................................ 222
3.1 BATTERY INSTALLATION / REPLACEMENT ....................................................................................... 222
3.2 SMARTZ app INSTALLATION ............................................................................................................233
3.3 CLIPPING SMARTZ POD ONTO PAD .................................................................................................233
3.3 USING THE SMARTZ APP..................................................................................................................255
4.0 SMARTZ Components Cleaning Instructions............................................................................................277
4.1 SMARTZ pod cleaning Guide............................................................................................................277
4.2 Recommended Cleaning Solution and Precautions......................................................................... 277
4.3 SMARTZ pod Cleaning and Inspection ...............................................................................................27
5.0 Contact and Support ..................................................................................................................................29
5.1 SMARTZ™ pod Indicator Light Colors ................................................................................................ 29
5.2 Troubleshooting Guide ...................................................................................................................... 29
5.4 Contact and support ..........................................................................................................................30
APPENDIX A SMARTZ™ system Specifications ................................................................................................. 32
SMARTZ physical Specifications............................................................................................................... 32
SMARTZ electrical Specifications.............................................................................................................32
SMARTZ pod BLUETOOTH Specifications................................................................................................. 32
SMARTZ devices Environmental Conditions............................................... Error! Bookmark not defined.
SMARTZ system Patient Environment ..................................................................................................... 33
SMARTZ system Manufacturers Declaration........................................................................................... 34
GLOSSARY......................................................................................................................................................... 37
List of Figures ................................................................................................................................................... 37

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Preface
PURPOSE OF THIS MANUAL
This manual contains important information regarding the safe operation of your SMARTZ system.
Ensure that you read and understand the information contained in this manual before operating any component
of SMARTZ system.
Further help on SMARTZ system is available in the SMARTZ APP.
The word Patient is defined as the person being cared for.
WARNING
Before operating the SMARTZ system read, understand and strictly follow the information contained in
Section 1.0 Safety Information.
QUALIFICATION OF PERSONNEL
Read the SMARTZ system warnings and cautions prior to usage. Simavita recommends that the registration and
maintenance of the SMARTZ system be performed by personnel with authority to make decisions on behalf of
the organization. Only use original parts and equipment approved by Simavita.
WARRANTY
Information regarding your product warranty will be available from your sales representative or Simavita.
DOCUMENT CONVENTIONS
This document uses the following typographic conventions:
Screen names and screen displays: BOLD+Calibri

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SECTION 1
SAFETY
INFORMATION

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1.0 Safety Information
1.1 DEFINITIONS
This manual uses three indicators to highlight critical information: WARNING, CAUTION and Note. These are
defined as follows:
WARNING
A WARNING indicates a condition that can endanger the Patient or the SMARTZ system operator.
CAUTION
A CAUTION indicates a condition that can damage the equipment.
Note:
A Note indicates points of particular emphasis that make the operation of the SMARTZ system more efficient or
convenient.
In order to use the system correctly and efficiently, and to help prevent incidents, please pay attention to Section
1.2 Warnings, Section 1.3 Cautions, as well as all warnings and cautions contained throughout this manual.

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1.2 WARNINGS
General Warnings Related to the Use of SMARTZ
WARNING
The SMARTZ system must be used according to the instructions provided.
A Patient in a clinical environment is highly vulnerable to the risks of infection. Dirty or contaminated equipment
is a potential source of infection. Clean the SMARTZ pod regularly and systematically, before and after each use.
Follow all internal procedures within your organization, as well as any maintenance procedures, to reduce the
risks of infection.
To reduce the risk of infection, organization’s standard operating procedures for cleaning, disinfection and
hygiene must be followed at all times. At a minimum you should wash your hands thoroughly before and after
handling any part of the SMARTZ system.
SMARTZ is not a substitute for standard care practices. Ensure that the care personnel is able and prepared to
take suitable action in the event if any part of the SMARTZ system experiences a problem.
If there is a leakage, as there may be with any continence product, there may be a risk of rash, sores and/or
compromise of skin integrity requiring medical intervention during a continence assessment. Care personnel
should continually monitor and interact with the Patient.
The SMARTZ sensor pad should not be applied to a Patient who has a known pre-existing skin condition, such as
a rash, sores and/or a compromise of skin integrity in accordance to organization clinical practices.
Some Patients may be sensitive to materials used in the SMARTZ components. It is important that the Patient’s
care provider continually monitors and interacts with the Patient. If the Patient is sensitive to the materials used
in the SMARTZ™ components, discontinue use and contact Simavita.
If a Patient develops a skin irritation as a result of wearing the SMARTZ sensor pad or pod, discontinue use and
care personnel should continually monitor and interact with the Patient.
SMARTZ sensor pads could potentially pose a biohazard risk. The SMARTZ sensor pads should be disposed of, as
per the standard operating procedures of your organization.
The LED Indicator lights on the SMARTZ pod indicate different events and functions. Refer to the Section SMARTZ
pod Indicator Light Colors for information on the LED Indicator light definition before determining the relevant
user action.
Ensure SMARTZ system components are stored and transported according to SMARTZ devices Environmental
Conditions as defined in APPENDIX A SMARTZ system Specifications.

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General Warnings Related to System Installation
WARNING
The SMARTZ system must not be installed in an environment that limits or prohibits RF transmitting devices.
The SMARTZ pod, sensor pad and app must not be used in the presence of medical imaging equipment such as
MRI machines, ECG machines, Defibrillators, etc.
Do not connect items which are not specified as part of the SMARTZ system.
The SMARTZ pod and SMARTZ sensor pad must not be stored or placed close to radiant heat sources, such as a
lit fireplace.
The SMARTZ pod and sensor pad must not be stored or placed close to the sources of steam, such as steam
kettles.
The SMARTZ pod and sensor pad must not be stored or placed close to microwave ovens.
Do not make changes to the App settings as this may render the system inoperable.
Warnings Regarding Maintenance
WARNING
•The SMARTZ pod should be inspected for any visible damage after every use and not less frequently
than every 12 weeks.
•Never use any component or accessory of the SMARTZ system that appears to be damaged or not
functioning correctly. If any signs of damage or malfunction are evident, discontinue use and contact
your supplier of the SMARTZ system.
•If you cannot determine the cause of the problem with any component or accessory of the SMARTZ
system, contact supplier. Do not use the SMARTZ system until the problem has been corrected.
•Do not attempt to repair, modify or service any component or accessory of the SMARTZ system. The
system does not contain any user serviceable parts. Doing so might cause damage and/or void your
warranty.
•Only clean SMARTZ components with cleaning agents specified in cleaning instructions. Read and follow
the cleaning and additional instructions on the cleaning agents to clean the SMARTZ components.
•The SMARTZ sensor pad is intended for single use only. Use as per manufacturer instruction and do not
attempt to wash or reuse these components.
•Only perform upgrades to any software components of the SMARTZ system by following instructions
provided by Simavita.
•Never use accessories, detachable parts or materials that are not described in this User Manual. To order
new accessories, please contact supplier.
•The SMARTZ pod must not be serviced or maintained when in use on a Patient.

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Warnings Regarding Oxygen
WARNING
•The SMARTZ system is NOT suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE
WITH AIR or with OXYGEN or NITROUS OXIDE.
Warnings Regarding Instructional Safeguards for batteries
WARNING
•The SMARTZ pod contains a user replaceable coin cell battery, type CR2016, contained behind a snap-
fit battery compartment lid that requires a small flat head screwdriver to open.
oDo not ingest battery, Chemical Burn Hazard.
oIf the coin / button cell battery is swallowed it can cause severe internal burns in just 2 hours
and lead to death.
oKeep new and used batteries away from children
oIf the battery compartment does not close securely, stop using the product and keep it away
from children
oIf you think batteries might have been swallowed or placed inside any part of the body, seek
immediate medical attention

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1.3 CAUTIONS
General Precautions for Use
CAUTION
•The SMARTZ pod may be damaged by excessive force being applied during cleaning. The cleaning
procedures specified in 3.0 SMARTZ components Cleaning Instructions must be followed to prevent
damage.
•The components of the SMARTZ system may be damaged through the use of harsh cleaning products.
The cleaning procedures specified in 3.0 SMARTZ components Cleaning Instructions must be followed
to prevent damage.
Precautions should be taken when handling the SMARTZ pod. Avoid touching the pins as this may trigger a
SMARTZ sensor pad connection event.
Precautions regarding Electromagnetic Interference
CAUTION
•The SMARTZ system requires special precautions for electromagnetic compatibility and should be
operated in accordance with the recommendations in this manual.
Note: The use of nearby mobile and portable communications equipment using radio frequencies
exceeding the levels set in the IEC 60601-1-2 standard may affect its operation.
The use of any accessory other than those specified may lead to an increase in electromagnetic emissions or a
decrease in the equipment protection against electromagnetic emissions.
General Precautions Related to the incorporation into the IT-network
CAUTION
•The connection of SMARTZ™ system to an IT network that includes other equipment could result in
previously unidentified risks to Patient, operators or third parties. The IT administrator should identify,
analyze, evaluate and control these risks before connecting the SMARTZ system to the network.
•Changes to the IT network including but not limited to changes in the IT network configuration,
connection of additional items to the IT network, disconnection of items from the IT network, the
update of equipment connected to the IT network and upgrade of equipment connected to the IT
network, could affect the operation of SMARTZ . The IT administrator should assess the risks to the
SMARTZ system before implementing any of these changes.

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1.4 SYMBOLS AND MARKINGS
Symbol Description
ISO 7010-W001 General Warning sign.
This symbol accompanies WARNING in Simavita product
literature.
IEC 60417-5140 (2003-04) Equipment includes an RF
transmitter.
This symbol appears on the SMARTZ™ pod.
ISO 7000-2498 Serial Number
This symbol appears on all SMARTZ components.
WEEE (Waste Electrical and Electronic Equipment)
This means the product must not be disposed of as household
waste. Observe local ordinances for proper disposal.
This symbol appears on all SMARTZ™ components. Refer to
section 1.6 Disposal for information and instructions for
disposal.
RCM
Compliance with Electrical Equipment Safety System (EESS) of
Australian Communications and Media Authority (ACMA)
Regulation.
This symbol appears on the SMARTZ pod.
CE Marking. Declares that the product conforms to the
essential requirements of the applicable EC directives.
This symbol appears on the SMARTZ components and all
accompanying documentation and packaging.
United States FCC
This SMARTZ™ pod complies with Part 15 of the Federal
Communications Commission (FCC) Rules.
The FCC ID for SMARTZ™ pod is: SBG-8000-POD
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 symbol appears in the package insert for SMARTZ pod.

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IP54
IP rating code of Smartz pod, which classifies the protection
against intrusion from dust and water.
This symbol appears on the SMARTZ pod.
The first digit indicates the level of protection that the
enclosure provides against access to hazardous parts The
number 5 indicates that the enclosure is protected from
limited dust ingress.
The second digit indicates the level of protection that the
enclosure provides against harmful ingress of water. The
Number 4 on SMARTZ pod indicates that pod is protected
against water splashed from all directions.
Keep Dry.
This symbol appears on the SMARTZ pod packaging.
Indicates that the packaging should be recycled.
This symbol appears on the SMARTZ pod packaging.
Device includes static sensitive components: take appropriate
precautions

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1.5 LABELS
Various labels and specific markings are affixed to the SMARTZ system components that describe precautions
and contribute to traceability of the product. The labels are identified in the table below with illustrations of
their location.
Label Description Location
SMARTZ pod label

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1.6 DISPOSAL
This section describes the steps to safely dispose the SMARTZ components and accessories.
SMARTZ SENSOR PAD
The SMARTZ sensor pad may pose a biohazard risk after usage. The SMARTZ sensor pad should be disposed of
in accordance with the standard operating procedures at your facility for bio hazardous waste.
SMARTZ POD
The SMARTZ pod contain electronic parts and CR2016 Lithium batteries. These should not be disposed of in
standard waste.
The SMARTZ pod has a useful operating life of three (3) years.
WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic
equipment. These devices should be disposed of separately, not as unsorted municipal waste. To dispose of your
device, you should use appropriate collection, reuse and recycling systems available in your region. The use of
these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent
hazardous substances from damaging the environment. If you need information on these disposal systems,
please contact your local waste administration. The crossed-bin symbol invites you to use these disposal
systems. If you require further information on collection and disposal of your Simavita device please contact
Simavita.

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SECTION 2
OVERVIEW

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2.0 Overview
2.1 WHAT IS THE SMARTZ SYSTEM
SMARTZ is a smart diaper solution for adults and infants. A SMARTZ pod is attached to sensor pad, the pad
contain printed sensors providing real-time alerts to caregivers that “it’s time to change” (Figure 1). It is
simple to use, intelligent and affordable, providing peace of mind to caregivers and parents.
Figure 1 SMARTZ sensor pad and pod
The SMARTZ is a lightweight, slim, wearable technology that clips onto diapers that is sufficiently economical
for everyday use. The simple form is easy to use and comfortable for the wearer to attach and detach from a
diaper. The SMARTZ pod (see Figure 2) has been designed to operate continuously and monitor the wetness of
diaper 24/7. It uses Bluetooth to transmit data to the SMARTZ APP running on a smart device for processing
and display.

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Figure 2 SMARTZ pod
The SMARTZ app (Figure 3) provides single and multi-user monitoring capabilities allowing it to be used at
home or in care organizations. Data from multiple sensor readings are analyzed to filter out noise, reducing
false positive alerts. The app employs patented data analytic techniques to generate trends and present
patterns so users can make quick and informed decision on care provision.
To assist in managing many users, a triaging and traffic light system can prioritize care based on location and
context. In single user mode, and in the case of the smart watch, it can report sensor readings of the closest
Pod in the vicinity.

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Figure 3 SMARTZ™ app
When a SMARTZ app uses a traffic light system to inform the user of the optimum time to change product and
reduce risk of urine leakage. A Green status is shown when the SMARTZ pad is dry, when it is wet but still
within safe pad capacity it turns Yellow. When safe pad capacity has been reached or exceeded the status
turns Red to inform the user to change the product.
Figure 4 Overview of the SMARTZ app Time-To-Change status

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2.4 THE SMARTZ TECHNOLOGY COMPONENTS
SMARTZ uses industry standard Bluetooth technology to connect to virtually all smart devices available on the
market. Sensor data and knowledge can be shared to distribute workload and improve continuity of care.
Figure 5 SMARTZ™ network
SMARTZ consists of a number of components to enable the system to function. These components are stated
and described in the following table:
SMARTZ™ components
Component Description User interaction
SMARTZ™ sensor pad
Disposable single-patient-use incontinence pad (diaper), with
integrated wetness sensor for daily use.
The SMARTZ sensor pad consists of a standard continence
pad (diaper) with printed capacitive sensors. The sensor has
2 sets capacitive electrodes
for improved reliability and
coverage.
Sensors work on the principle of capacitance
similar to touch screens on mobile phones. The sensors
detect the accumulation of liquid in the diaper over time.
Care staff, Patient
SMARTZ™ pod
A portable, reusable data transceiver that is connected to the
SMARTZ sensor pad and worn daily or as needed
by the
Patient.
The SMARTZ pod
is a small and lightweight data logging
device. The pod has been designed to an IP54 rating, allowing
it to be cleaned by wiping with cleaning solutions. The
SMARTZ pod contains a CR2016 Lithium
battery and an
electronic circuit board containing Bluetooth radio module,
micro-controller, memory, and charging circuitry. SMARTZ
Care staff,
organization IT
staff (during
setup)

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pod is equipped with a safety circuit that limits the electrical
energy available when a SMARTZ™ sensor pad is connected.
SMARTZ pods should be associated to a patient prior to use
via the SMARTZ app. The SMARTZ pod requires connection to
SMARTZ pad and SMARTZ APP to perform its monitoring and
notification function.
Figure 6 SMARTZ™ pod
SMARTZ™ app
A software application operating on a smart device
performing data collation, storage, processing and display
function. Analyses data transmitted from the Pod and informs
the user of diaper status and best time to change product.
Monitors come in two variants, dedicated and smart device.
The dedicated monitor is a completely plug and play bedside
unit that changes color depending on diaper wetness. A smart
device can function as a monitor when the SMARTZ™ app is
installed. The app extends the monitoring capability by
analyzing and presenting health status information thru the
touch screen interface.
Care staff