Copyright 2013 Simavita Pty Ltd. All rights reserved.
SIM™ and SIM™ with logo are trademarks of Simavita Pty Ltd. The information contained in this User Guide is
the sole property of Simavita and may not be duplicated without permission. This User Guide manual may be
revised or replaced by Simavita Pty Ltd at any time and without notice. You should ensure that you have the
most current applicable version of this manual; if in doubt contact Simavita Technical Support Department.
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Table of Contents
Copyright Information ............................................................................................................................... 2
Table of Contents ............................................................................................................................................... 3
Purpose of this manual .............................................................................................................................. 1
Qualification of Personel ........................................................................................................................... 1
1.0 Safety Information ....................................................................................................................................... 4
2.1 What is the SIM™ system .................................................................................................................. 16
2.2 Indications for Use ............................................................................................................................. 19
7.9 Observation History ........................................................................................................................... 74
8.0 SIM™ Continence Care Plan ....................................................................................................................... 77
8.1 SIM™ continence care ....................................................................................................................... 77
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8.2 Create a continence care plan ........................................................................................................... 78
8.3 Under Evaluation ............................................................................................................................... 89
8.4 Continence care plan In Use .............................................................................................................. 91
8.5 Draft continence care plan ................................................................................................................ 91
8.6 Continence care plan History box ...................................................................................................... 92
Contact and Support .............................................................................................................................. 173
Your Organisation Contact and Support ................................................................................................ 173
APPENDIX A .................................................................................................................................................... 175
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Preface
PURPOSE OF THIS MANUAL
This manual contains important information regarding the safe operation of your SIM™ system. Your SIM™
system contains electrical components that can provide years of useful service with the proper care, as
described in this manual.
Ensure that you read and understand the instructions contained in this manual before operating any
component of the system.
Further training on SIM™ system is available at the SIM™ training website.
http://www.simavita.com/training
The word resident is defined as the patient or the person been cared for.
WARNING
Before operating the SIM™ system, read, understand, and strictly follow the information contained in
Chapter 1, “Safety Information”.
QUALIFICATION OF PERSONEL
Installation and maintenance of the SIM™ system must be made by authorized and trained personnel using
original components and respecting the quality assurance and traceability rules approved by Simavita.
WARRANTY
Information regarding your product warranty is available from your sales representative or Simavita.
This manual uses three indicators to highlight critical information: Warning, Caution and Note. They are
defined as follows:
WARNING
A WARNING indicates a condition that can endanger the resident or the SIM™ 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 SIM™ system more efficient or
convenient.
In order to use the system correctly and efficiently, and to help prevent incidents please pay particular
attention to sections 1.2 “Warnings” , 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 Use of the SIM™ system
WARNING
The SIM™ system must be used according to its intended use. Refer to section 2.2 Indications for Use.
A resident in a Long Term Care facility is highly vulnerable to the risks of infection. Dirty or
contaminated equipment is a potential source of infection. Clean the SIM™ pod and SIM™ dock
regularly and systematically, before and after each use. Follow all internal procedures to your
organization, as well as any maintenance procedures, to reduce the risks of infection.
To reduce the risk of infection, facility 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 SIM™ system.
SIM™ is not a substitute for standard care practices. A resident undergoing a continence assessment
should always be monitored by trained and competent personnel. Ensure the resident’s carer is able
and prepared to take suitable action in the event that any part of the SIM™ system experiences a
problem.
If there is 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.
The resident’s carer should continually monitor and interact with the resident.
The SIM™ sensor should not be applied to a resident who has a known pre-existing skin condition,
such as a rash, sores and/or a compromise of skin integrity.
Some residents may be sensitive to materials used in the SIM™ components. It is important that the
resident’s carer continually monitors and interacts with the resident. If the resident is sensitive to the
materials used in the SIM™ components, discontinue use and contact Simavita.
If a resident develops a skin irritation as a result of wearing the SIM™ sensor, discontinue use and the
resident’s carer should continually monitor and interact with the resident, and refer to 12.0 SIM™
Contact and Support for contact details.
The SIM™ pants and SIM™ sensors could potentially pose a biohazard risk after an assessment. The
SIM™ pants and SIM™ sensors should be disposed of, as per standard operating procedures for your
facility.
The Indicator Lights on the SIM™ pod indicate different events and functions. This User Manual should
be consulted for Indicator Light definitions before determining the relevant user action.
Ensure SIM™ system components are stored and transported according to SIM™ environmental
conditions as defined in Appendix A.
The SIM™ pod shall only be charged with the adapter model defined in Electrical Specifications in
Appendix A.
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General Warnings Related to System Installation
WARNING
The SIM™ system must be installed as per the instructions in section 11.0 SIM™ Installation,
Maintenance and Disposal of this user manual.
The SIM™ system must not be installed in an environment that limits or prohibits RF transmitting
devices.
Do not connect items which are not specified as part of the SIM™ system.
The SIM™ pod, SIM™ dock and SIM™ sensor most not be stored or placed close to radiant heat
sources, such as a lit fireplace.
The SIM™ pod, SIM™ dock and SIM™ sensor must not be stored or placed close to sources of steam,
such as steam kettles.
The SIM™ pod, SIM™ dock and SIM™ sensor must not be stored or placed close to microwave ovens.
Do not make changes to the SIM™ system database (stored on the server used for SIM™) as these may
render the system inoperable.
Warnings Regarding Maintenance
WARNING
The SIM™ pod should be inspected for damage to the case and clip after every assessment and not
less frequently than every 12 weeks.
Never use any component or accessory of the SIM™ system that appears to be damaged or not
functioning correctly. If any signs of damage or malfunction are evident, discontinue use and contact
Simavita.
If you cannot determine the cause of the problem with any component or accessory of the SIM™
system, contact Simavita. Do not use the SIM™ system until the problem has been corrected.
Do not attempt to repair, modify or service any component or accessory of the SIM™ system. The
system does not contain any user serviceable parts. Doing so might cause damage and/or void your
warranty. Only qualified service personnel should attempt to repair the SIM™ system.
Only clean SIM™ components with cleaning agents specified in this manual. Read and follow the
cleaning instructions and additional instructions (section 10.0 SIM™ cleaning instructions) on the
cleaning agents, to clean the SIM™ components.
The SIM™ sensor and SIM™ pants are intended for single use. Use these only as per Simavita’s
instruction and do not attempt to wash or reuse these components.
Only perform upgrades to any software components of the SIM™ system by following instructions
provided by Simavita and using official software installation packages or as directed by an authorized
Simavita representative.
The SIM™ pod safety circuit may be triggered during the cleaning process. The SIM™ pod should
always be placed on a powered SIM™ dock for a few moments after cleaning to reset the safety circuit.
Never use accessories, detachable parts or materials that are not described in this User Manual. To
order new accessories contact Simavita.
The SIM™ pod must not be serviced or maintained when in use on a Resident
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Warnings Regarding Oxygen
WARNING
The SIM™ system is NOT suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE
WITH AIR or with OXYGEN or NITROUS OXIDE.
1.3 CAUTIONS
General Precautions for Use
CAUTION
The SIM™ pod and SIM™ dock may be damaged by excessive force being applied during cleaning. The
cleaning procedures specified in this User Manual must be adhered to prevent damage.
The components of the SIM™ system may be damaged through the use of harsh cleaning products.
The cleaning procedures specified in this User Manual must be adhered to, to prevent damage.
Precautions should be taken when handling the SIM™ pod as touching the pins may trigger a SIM™
The SIM™ system requires special precautions for electromagnetic compatibility and should be
installed and started in accordance with the recommendations found in Section 3.0. In particular, 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 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.
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General Precautions Related to the incorporation into the IT-network
CAUTION
The connection of SIM™ pod to an IT network that includes other equipment could result in previously
unidentified risks to resident, operators or third parties. The IT administrator should identify, analyse,
evaluate and control these risks before connecting the SIM™ pod to the network. IEC 80001-1:2010
provides guidance for the IT administrator to address these risks.
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 SIM™. The IT administrator should assess the risks to the SIM™
system before implementing any of these changes.
The details provided in the I.T. Fact Sheet – IT requirements to support SIM™ defines the requirements
of the IT-network infrastructure for the operation of SIM™ as intended by Simavita. The failure of the
IT network to meet these requirements may result in the SIM™ system, the IT network or other
devices connected to the IT-network, operating in an unintended manner.
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1.4 SYMBOLS AND MARKINGS
Symbol
Description
IEC 60417-5333 Type BF Applied Part
This symbol appears on the SIM™ pod
IEC 60417-5031 Direct Current
This symbol appears on the SIM™ dock.
ISO 7000-1051 Single Use, Do not Reuse
This symbol appears on the SIM™ sensor and SIM™ pants
packaging.
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 SIM™ pod.
ISO 7000-3082 Device manufacturer.
This symbol appears on all SIM™ components.
ISO 7000-2497 The date when the medical device was
manufactured.
This symbol appears on all SIM™ components.
The date will be adjacent to the symbol in the YYYY-MM
format.
ISO 7000-2607 The date after which the medical device is
not to be used.
This symbol appears on all SIM™ sensor packaging and
packaging label.
The date will be adjacent to the symbol in the YYYY-MM
format.
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ISO 7000-2493 Manufacturers Catalogue number
This symbol appears on all SIM™ components.
ISO 7000-2498 Serial Number
This symbol appears on all SIM™ components.
ISO 7000-2492 Batch Code
This symbol appears on the SIM™ sensor.
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 SIM™ devices. Refer to section 11
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 all SIM™ devices.
CE Marking. Declares that the product conforms to the
essential requirements of the applicable EC directives.
This symbol appears on all SIM™ pod and SIM™ dock, and all
accompanying documentation and packaging.
United States FCC
This SIM™ pod complies with Part 15 of the Federal
Communications Commission (FCC) Rules.
The FCC ID for SIM™ pod is XF6-RS9110N1122.
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 SIM™
pod/dock kit.
ISO 7000-1641 Operating Instructions.
This symbol appears on package inserts that are shipped
with SIM™ devices. It is used to convey that the User Manual
should be consulted before using the SIM™ devices.
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E365191
Medical Equipment
This symbol appears on the SIM™ pod to signify that the
product is certified to UL standards for Medical Equipment
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005+C1+A2), CSA C22.2 No 60601.1
(2008), IEC/EN 60601-1 (2005/2006+C1+C2), 60601-1-6
Usability (2010), 60601-1-11 (2010).
The UL control number for the SIM™ pod is E365191.
USB trident logo.
This symbol appears on the SIM™ dock to mark the location
of the USB connector.
Polarity Symbol.
This symbol appears on the SIM™ dock to mark the location
and the polarity of the DC connector.
This symbol appears on SIM™ pod to mark the location of
the power Indicator Light.
Refer Appendix A for SIM™ pod Indicator Light indication
colours
This symbol appears on SIM™ pod to mark the location of
the network Indicator Light.
Refer Appendix A for SIM™ pod Indicator Light indication
colours
This symbol appears on the SIM™ pod to mark the location
of the memory Indicator Light.
Refer Appendix A for SIM™ pod Indicator Light indication
colours
IP67
IP rating code of SIM pod, which classifies the protection
against intrusion from dust and water.
This symbol appears on the SIM™ pod.
The first digit indicates the level of protection that the
enclosure provides against access to hazardous parts; The
number 6 indicates that the enclosure is dust tight.
The second digit indicates the level of protection that the
enclosure provides against harmful ingress of water. The
Number 7 on SIM™ pod indicates that SIM™ pod can be
immersed in water up to 1 meter for a maximum of 30
minutes.
Keep away from Direct Sunlight.
This symbol appears on the SIM™ pod-dock packaging and
the SIM™ sensor packaging.
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Keep Dry.
This symbol appears on the SIM™ pod-dock packaging and
the SIM™ sensor packaging
Indicates the acceptable temperature range for transport
and storage.
This symbol appear son the SIM™ pod-dock packaging and
the SIM™ sensor packaging
Indicates the acceptable humidity range for transport and
storage.
This symbol appears on the SIM™ pod-dock packaging and
the SIM™ sensor packaging
Indicates that the packaging should be recycled.
This symbol appears on the SIM™ pod-dock packaging and
the SIM™ sensor packaging
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1.5 LABELS
Label
Description
Location
SIM™ pod label
SIM™ dock
identification
label
(Bottom of
Dock)
Various labels and specific markings are affixed to the SIM™ 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.
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1.6 STANDARDS AND COMPLIANCE AND IEC CLASSIFICATION
Description
Specification
Model Number
6019
Mode of Operation
Continuous Operation
Protection against ingress of water
IP67
Applied Part
Type BF
Use in presence of flammable
anaesthetic mixtures
No
Suitable for Sterilisation
No
The SIM™ system was developed in accordance with pertinent North American and International standards.
The SIM™ pod with SIM™ sensor IEC 60601-1/EN 60601-1 classification is as follows:
GENERAL STANDARDS – SIM™ POD AND SIM™ SENSOR
Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance,
IEC/EN 60601-1 (2005/2006+C1+C2)
Medical Electrical Equipment – Part 1: General Requirements for Safety, CSA C22.2 No 60601.1 (2008)
Medical Electrical Equipment – Part 1: General Requirements for Safety, ANSI/AAMI ES60601-1
(2005+C1+A2)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk
management process
COLLATERAL STANDARDS – SIM™ POD AND SIM™ SENSOR
Medical Electrical Equipment – Part 1: General requirements for Safety - Collateral standard Electro-
Magnetic Compatibility requirements and tests IEC 60601-1-2 2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance
SIM™ is used by carers in resident aged care facilities during an incontinence assessment to gather relevant
information and record events which are automatically displayed on a bladder diary. This process helps create
an accurate incontinence record.
Direct physiological urinary incontinence data is detected by a sensor strip embedded in an absorbent
incontinence product (SIM™ sensor Figure 1) worn by the resident during the assessment period. All
incontinence events are detected and transmitted by a small pod (SIM™ pod) attached to the front of the SIM™ sensor pad worn by the resident during the assessment.
Figure 1 SIM™ sensor
The SIM™ pod (Figure 2) has been designed to operate continuously over the entire assessment period and
utilises Wi-Fi capabilities to send event data back to a server based software application (SIM™ manager) for
processing into useful data for clinicians to review. In addition to the direct urinary incontinence data
feedback, carers collect data using an intuitive point of care application called ‘SIM™ assist’.The SIM™ dock
(Figure 2) is used to charge battery of the SIM™ pod in between assessments.
Figure 2 SIM™ pod and dock
SIM™ assist application (Figure 3) operates on smart phone devices such as Android phones or tablets. The
portability of a device containing the SIM™ assist allows the carer to record relevant data about the resident
under assessment at the time of each event. Data events include: food and fluid intake; successful and
unsuccessful toileting; sensor changes; behaviours; and other therapy activities related to urinary incontinence
care.
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Figure 3 SIM™ assist application
When a SIM™ assessment has been completed, data can be viewed in a comprehensive bladder diary. The
SIM™ manager software provides a structured decision support process to guide the development of effective
individualised continence care plans for each assessed resident. This assessment process is depicted in the
cycle shown in Figure 4.
Figure 4 Overview of the SIM™ assessment process
The SIM™ manager software produces real time bladder information combined with a carer’s observations, a
sample of which is shown in Figure 5.
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Figure 5 Sample of the Bladder and Assessment Chart
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2.2 INDICATIONS FOR USE
SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to collect, transmit
and report medical information from multiple residents (patients) within a clinical setting (e.g. hospitals,
skilled nursing facilities, residential care facilities) to establish effective management plans for continence care.
INTENDED USE
SIM™ (Smart Incontinence Management) is a remote monitoring system intended to provide monitoring
services of resident continence data by remote transmission. It is intended for use by trained healthcare
professionals to remotely detect, record and report incontinence events for individual resident (patient) in
long term care facilities, skilled nursing facilities, rehabilitation facilities and hospitals.
2.3 CONTRAINDICATIONS
There are no known contraindications.
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2.5 THE SIM™ TECHNOLOGY COMPONENTS
SIM™ components
Component
Description
User interaction
SIM™ sensor
Disposable single-patient-use incontinence pad (diaper), with
integrated wetness sensor, used during an assessment.
The SIM™ sensor consists of a standard continence pad (diaper) with
an embedded electronic circuit. The electronic circuit provides for 6
sensing electrodes and a means to distinguish a new sensor from a reapplied sensor. The SIM™ sensor is a Type BF applied part.
Care staff, resident
SIM™ pants
Disposable single-patient-use standard over-pants used in conjunction
with the SIM™ sensor to keep the sensor in place. The SIM™ pants
have a pocket sewn inside the front top part of the pants to
accommodate the SIM™ pod during assessments.
Care staff, resident
SIM™ pod
A portable, reusable, rechargeable sensor data transceiver that is
connected to the SIM™ sensor and worn by the resident during an
assessment.
The SIM™ pod is a small and lightweight data logging device. The pod
has been designed to an IP67 rating, allowing it to be submerged under
water for ease of cleaning. The SIM™ pod contains a rechargeable Li-
Care staff, facility IT
staff (during setup)
SIM™ operates over a Wi-Fi network, but does not require continuous connection. The SIM™ pod is capable of
completing an entire assessment without connection to a network via Wi-Fi, but requires such a connection in
order to upload all collected information. Figure 6illustrates the SIM™ network.
Figure 6 SIM™ network
SIM™ consists of a number of components to enable the system to function. These components are stated
and described in the table below.
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Ion battery and an electronic circuit board containing Wi-Fi radio
module, micro-controller, and memory and charging circuitry. SIM™
pod is equipped with a safety circuit that limits the electrical energy
available when a SIM™ sensor is connected.
SIM™ pods must be configured to use the facility’s Wi-Fi network prior
to use; configuration can be done using a client PC connected to the
server and the SIM™ pod via a USB cable and is only required once,
unless Wi-Fi network changes are made.
SIM™ dock
Recharging station for the SIM™ pod. The SIM™ dock includes a low
voltage supply connected to mains electricity.
The SIM™ dock provides an electrical and mechanical means to
connect a 5V power supply and a USB cable (for configuration). The
dock does not contain any additional electronics.
Note:
Only the low voltage power supplies specified in this User
Manual are approved for use with SIM™.
Care staff, facility IT
staff (during setup)
SIM™ assist
A software application (app) operating on an Android phone or tablet
used for recording resident observations, such as successful toileting or
fluid intake; also used to provide SIM™ assessment messages to users.
Recorded observations are uploaded via Wi-Fi to the server side SIM™
software.
The SIM™ assist app is currently supported for Android OS3.2
(Honeycomb) or later.
Care staff
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SIM™ manager
An element of the SIM™ system software which provides a user
interface through a web browser. SIM™ manager allows for resident
and staff profiles to be managed and assessments and continence care
plans to be created, monitored and reported.
SIM™ manager utilises Microsoft Silverlight to support the operation of
the graphical user interface; it is available through the server’s IP
address.
Care staff
Client
computers
Facility supplied computers able to connect to the server running the
SIM™ systemsoftware; used for running SIM™ manager in the client
side browser.
Please refer to the minimum system requirements on the IT Fact Sheet.
Care staff, facility IT
staff
Server
computer
A facility supplied workstation computer running the SIM™ software
services.
Please refer to the minimum system requirements and pre-installation
requirements on the IT Fact Sheet.
Facility IT staff
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The SIM™ dock recharges the SIM™ pod, so it will be ready
for the next assessment. Place the SIM™ pod into the
SIM™ dock with both blue logos facing forward.
The battery indicator light will flash green when the SIM™
pod is charging. Once the pod is fully charged the indicator
light will turn solid green.
The Wi-Fi indicator light initially flashes orange and will
turn solid green when connected to the Wi-Fi network.
The synchronising indicator light initially flashes orange
and will turn solid green once all assessment data is
uploaded.
The SIM™ pod is ready to be used for an assessment when
all three indicator lights are solid green.
The SIM™ pod indicator lights summary.
SIM™ pod
Symbols
Indicator Light
Indicator Light
Battery
GREEN (flashing)
Recharging
GREEN (solid)
Fully charged
Wi-Fi
Orange (flashing)
Connecting
GREEN (solid)
Connected
Synchronising
Orange (flashing)
Data uploading
GREEN (solid)
completed
All Symbols
If any indicator light turns solid RED,
refer to APPENDIX A and the
Troubleshooting Guide in 12.0 SIM™
Contact and Support.
3.1 CHARGE THE SIM™ POD
The SIM™ pod must be charged before you start an assessment to ensure it can be used continuously for the
entire 72-hour (3 days) continence assessment period.
It takes about 2-3 hours to fully charge a depleted SIM™ pod.
Note:
A SIM™ pod that has been in storage without charging for a period of six months or more may require more
than 3 hours to fully charge. Simavita recommends that when a SIM™ pod is not in use it should be placed on
the SIM™ dock and/or fully charged at least once every three months.
Follow these steps to charge the SIM™ pod.
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3.2 Connect SIM™ pod to SIM™ sensor
Step 1
Check that the pod number on the back of the SIM™ pod
matches the number allocated for that SIM™ assessment.
Step 2
Remove the SIM™ sensor from its sealed bag by tearing
the top of the bag at the pre-cut notch.
Step 3
Connect the SIM™ pod to the SIM™ sensor; match the
window in the sensor clip to the raised shape on the SIM™
pod, then hook the clip over the pod.
Step 4
Press firmly down on the end of the clip, until a click is
heard. Green lights will flash briefly across all three
indicator symbols to confirm the SIM™ pod is connected
successfully.
Note:
If the SIM™ pod connection is unsuccessful the lights
flash green then turn orange briefly across all three
indicator symbols. You will need to repeat the
connection process.
If the battery is low the battery indicator light will flash
orange indicating the pod needs to be recharged.
If the SIM™ pod memory is almost full, the
synchronising indicator light flashes orange and must
be returned to the SIM™ dock.
To connect the SIM™ pod to the SIM™ sensor, follow these steps:
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Step 1
Disconnect the SIM™ sensor from the SIM™ pod by
hooking your index finger behind the clip while placing
your thumb firmly on the front of the clip.
Step 2
Pull your index finger forward, until the clip is released.
SIM™ pod disconnection is confirmed by three orange
lights flashing briefly across all three indicator symbols
3.3 DISCONNECT THE SIM™ POD FROM THE SIM™ SENSOR
To disconnect the SIM™ pod from the SIM™ sensor, follow these steps:
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