cl SIM™ User Manual | Prod Code: 02579_03 | Version: 3a 1
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 help is required; please contact Simavita Technical Support Department.
Table of Contents Copyright Information ............................................................................................................................... 2 Table of Contents ............................................................................................................................................... 3 Preface ...............................................................................................................................................................
Preface Purpose of this manual This manual contains important information regarding the safe operation of the Smartz™ system. Ensure that the information contained in this manual has been read and understand 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. This manual forms the Instructions for Use of the Smartz™ device.
SECTION 1 SAFETY INFORMATION Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 5
1.0 Safety Information 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.
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.
Antivirus is recommended for the smart devices using the Smartz™ app to reduce the risk of third party intervention Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 8
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.
Never use accessories, detachable parts or materials that are not described in this User Manual. To order new accessories, please contact supplier of the smartz™ system. The Smartz™ pod must not be serviced or maintained when in use on a Patient. 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.
Cautions General Precautions for Use CAUTION The Smartz™ pod may be damaged by excessive force being applied during cleaning. The cleaning procedures specified in 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 Smartz™ components Cleaning Instructions must be followed to prevent damage. Precautions should be taken when handling the Smartz™ pod.
Symbols and markings Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 12
Table 1. Symbols Symbol Description IEC 15223 -1General 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. IEC 15223-1Serial Number This symbol appears on all Smartz Pod label and package label WEEE (Waste Electrical and Electronic Equipment) This means the product must not be disposed of as household waste. Observe local ordinances for proper disposal.
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.
Indicates that the device is a Medical Device This symbol appears on the Smartz Pod Packaging label IEC 15223-1 Device Manufacturer The symbol appears on the Smartz Pod Package Label The date when the Smartz Pod was manufactured The symbol appears on the Smartz Pod Package Label The date will be adjacent to the symbol in the YYYY-MM format IEC 15223-1 Manufacturers Catalogue Number This symbol appears on the Smartz Pod Packaging Label IEC 15223-1 Indicates electronic instruction for use This symbol appear
Table 2. Labels Description Location Smartz Pod Label Smartz Pod Packaging Label Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 Packaging box.
Smartz Shipper Box Label Patient Privacy and Security Users are required to accept an EULA (end user licence agreement) to use the product. All patient data is held on secure Smartz™ cloud servers. It is the responsibility of the User to ensure that the physical security of all devices used for Smartz™ monitoring is maintained.
SECTION 2 OVERVIEW Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document number: SAS_GEN1_0039 | Revision: 2 18
2.0 Overview 2.1 What is the Smartz™ system Smartz™ is a safe, smart solution for aged care that can monitor a variety of wellness signs in Patients. A Smartz™ pod is attached to a Smartz™ sensor pad (Figure 1). The sensor pad has embedded sensors which allow for realtime notifications to the caregivers that “it’s time to change”. Smartz™ is simple to use, intelligent, affordable, safe and provides peace of mind to caregivers.
Intended Use The Smartz™ system is intended to provide monitoring services of continence and related wellness data by remote transmission.
The information these systems deliver can be integrated into continence care plans created by Carers and will more accurately meet the true needs of each individual Patient. 2.5 The Smartz™ System Components Smartz™ uses industry standard Bluetooth technology to connect to smart devices available on the market. Sensor data and knowledge can be shared to distribute workload and improve continuity of care. Smartz™ consists of a number of components to enable the system to function.
Smartz™ app A software application operating on a smart device performing data Carer collation, storage, processing and display functions. Analysed data is transmitted from the Pod to the smart device via Bluetooth technology and informs the user of the ambient temperature surrounding the pod, body position, time in position and the best time to change product based on the sensor pad wetness. A smart device can function as a ‘Monitor’ when the Smartz™ app is installed.
Smartz™ dashboard A website that allows monitoring of many Patients at once on a smart Carer device, such as a laptop or iPad, giving a holistic view for Carers. Accessories to the Smartz™ system (refer to Appendix B for instruction for use of these accessories) Smartz™ nodes An IT router accessory to the system which allows an extended range of Carer, (or IT staff during Bluetooth signal and sends the data via Wi-Fi to allow remote monitoring setup) on the Smartz™ dashboard.
Figure 5 Node The interaction of all IoT components of the Smartz™ system is show below.
3.0 User Instructions 3.1 Smartz™ pod Battery Installation & Replacement The Smartz™ pod uses a replaceable Panasonic CR2016 battery. Follow the instructions below to install the battery for first time use or to replace the battery: 1. Place the Smartz™ pod face up on a flat surface. 2. Insert a flat tool into battery compartment and carefully pry the battery compartment open. 3. Remove the old battery and install the new one (CR2016) with the plus (+) symbol facing up. Figure 4. Battery Replacement 4.
3.2 Clipping Smartz™ pod onto Smartz™ sensor pad To enable the monitoring function, the Smartz™ pod needs to be clipped onto the Patients Smartz™ sensor pad as follows: 1. Open the Smartz™ pod clip Figure 6.
2. Line up the three (3) stripes of the Smartz™ sensor pad with the three (3) dots on the Smartz™ pod. Figure 7. Clip onto pad location • Clip the Smartz™ pod onto the front of the Smartz™ sensor pad 3. The light on the Smartz™ pod will momentarily flash green to indicate that it has been clipped onto the Smartz™ sensor pad correctly. For all other pod LED light instructions, refer to Section 3.3 Smartz™ pod Indicator Light Colours. 4.
Figure 8.
3.3 Smartz™ pod Indicator Light Colours The following is a table is a summary of instructions for the different Smartz™ pod LED indicator lights mentioned previously in this instructions document. Table 4.
Table 5.
Register a Patient (see section Manage Patients) Accept EULA Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 13
Ready to go Help Videos Accessed via the Menu after setup Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 14
Standalone versus Group Membership Devices The monitoring device can be used as either a standalone monitoring device or it can be used to create a user account to manage groups of Patients or join another user account that already exists. / A user account is required to manage a group of Patients / Using the device as a standalone Monitor In this mode, the monitoring device does not interact with any cloud functionality.
5. The Smartz™ pod will need to be attached to the Smartz™ sensor pad. Read the Smartz pod number on the inside of the pod eg. SN S-000-050. 6. Assign the uniquely identified Smartz™ pod by pressing Assign and a list of pods available will be shown. 7. Press Save when the correct pod number appears. NOTE: If the pod number is not the one intended for the Patient, click the number to show a selection of all pods nearby. 8.
The Patient is now added. Multiple Patients can be added to a smart device via the Smartz™ app and can be seen on the screen. To edit Patient details or assign a new unique Smartz™ pod to that Patient, press Edit and select the Patient to edit.
To delete (remove) a Patient from the smart device, press Delete and select the Patient to delete (remove). NOTE: Patients will only be monitored on the app when the device running the app is in Bluetooth range of the Patients. Order of Status Display If multiple Patients are being monitored on a single smart device within the Bluetooth vicinity of that device, the Smartz™ app will shuffle through these Patients monitoring status.
Smartz™ Membership and User Accounts NOTE: Smartz™ Membership will only work when the device running the app is connected to the internet through Wi-Fi or 3G/4G/5G.
3. Press Add 4. Enter the Username, Email Address and Password for this user. Ensure the password is strong by utilising upper and lower case characters, symbols and numbers.
5. Press Save The User is now added. Multiple Users can be added to a smart device via the Smartz™ app. To edit Users details or assign a new unique Smartz™ pod to that Patient, press Edit and select the User to edit. To delete (remove) a User from the smart device, press Delete and select the User to delete (remove).
Note that the monitoring status of each Patient’s pod is not shared across the smart devices through this membership unless the monitoring app is in the same Bluetooth range of the shared Patients. SHARE CODE Groups can be expanded by having new monitoring devices share secure one-time codes with other monitoring devices, which already have a Group association. This enables access to the group’s patient and user data for this new monitor.
To enable this sharing: 1. Go to Menu on one of the smart devices intended to be shared to the group 2. Press Get Link Codes 3. The code only lasts 10 minutes! Otherwise, a new link code will have to be generated. 4.
5. Enter the code from step 4. The smart devices are now in the same Group and will cycle through all of the Patients in that Group. This process can be repeated indefinitely until the desired number of smart devices for Patients are all in the Group. One user can belong to many groups. One Group can have many users which may belong to other groups. NOTE: A monitoring device can be removed from a group in the Settings Menu.
Linking and Status Display of Models Scenario Share Code - Example #1 (device B not in a Group) Patients Alicia Carly (cloud) Patients Debbie (local) Patients Alicia Carly Debbie (cloud) User Account Jane (signed-in) User Account - User Account - Group Blue Group - Group Blue Device A 1. Generate Share Code from Device A Device B - standalone 2. Use Share Code from Device A Device B – with a group 3. Result of joining device B to Jane’s Group (Blue) 4.
Push Notifications The Smartz™ notification app is a mobile app extension to the monitoring app which allows users with user accounts to subscribe to push notification events for each Patient. This means users will receive remote notifications on the event statuses of their Patients when their device is connected to the internet, anywhere they are. This app can be obtained from app stores.
3.5 Understanding the Smartz™ System Features & Notifications The Smartz™ app is used to monitor the wellness features of the Patient. Wetness The Smartz™ app will show the following status based on wetness detected: Pad is dry Pad is wet Pad needs changing Figure 11. Traffic light display for time to change The following are recommended actions based on the status shown Table 6.
Time in pad Time in pad is shown to indicate how long the Patient has been in the same pad. Time in red Time in red indicates how long the red status has been displayed. Time in Position Time in position indicates how long the Patient has been in one position. The positions recognised are sitting, standing, lying on back, lying on their front and lying on either side. Falls Detection When a patient is falling, the pod detects this motion and a notification is received by the mobile device.
Table 7. Notifications Notification Description This occurs when there are no Patient pods connected to the smart device app. This occurs when the battery is low and requires either to replace the battery as per 3.1 Battery Installation & Replacement.
This occurs when the Pod is no longer clipped to the Patient’s pad when in range. Ensure the pod is correctly attached to the Patient’s pad. This occurs when the pod is not in range, or, if it is in range, the battery is completely drained. Bring the pod into range or replace its battery if it is in range and this message appears. See 3.1 Battery Installation & Replacement.
3.6 Smartz™ dashboard Using the Smartz™ dashboard Note: to use the dashboard, there must be an internet connection via the Smartz™ node. The setup of the Smartz™ node is not included as part of the scope of this User Manual and is assumed to be setup. The Smartz™ dashboard can be accessed on any device (such as a desktop, laptop or tablet) with a secure login via: http://dashboard.smartzhealth.
• • The Monitor must be linked Ensure node/mesh network is on and has connection to the internet 3.7 Smartz™ pod Cleaning Instructions Smartz pod cleaning Guide Simavita recognizes that cleaning and disinfection practices vary amongst Home and Care Facilities. It is not possible for Simavita to be responsible for the effectiveness of cleaning the Smartz components. Smartz components that come into contact with Patients need to be disinfected after each use.
3.8 Disposal This section describes the steps to safely dispose the Smartz™ components and accessories. 1. Smartz™ sensor pad The Smartz™ sensor pad may pose a biohazard risk after usage. The Smartz™ sensor pad should be disposed of appropriately according the pad manufacturer instructions. 2. Smartz™ pod The Smartz™ pod contains electronic parts and CR2016 Lithium batteries. These should be disposed of in accordance with WEEE 2002/96/EC European Directive.
4.
SECTION 4 TROUBLESHOOTING, CONTACT AND SUPPORT Smartz User Manual | Prod Code: 02864_2 Revision: 2 35
4.0 Troubleshooting, Contact and Support 4.
4.2 Contact and support Please contact Simavita or your authorized distributor via the contact information provided for assistance, if required, in setting up, using, maintaining or purchasing the Smartz™ system or to report unexpected operation or events. If a serious incident as occurred in relation to using this device, this should be reported to the manufacturer below and to the relevant competent authority of the Member State in which the user or patient is established.
Appendix A Smartz SPECIFICATIONS Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 38
5.0 Appendix A Smartz™ System Specifications Smartz™ Physical Specifications Description Length (mm) Width (mm) Height (mm) Weight (g) Smartz™ pod (inc. battery) 40 38 9 16 Smartz™ Electrical Specifications Smartz™ pod Replaceable Battery Description Specification Brand Panasonic CR2016 Chemistry Lithium Voltage 3.
Operating System Android 9 or greater, Apple iOS Version of app 1.0.
Smartz™ dashboard specifications Description Specification Dashboard URL dashboard.smartzhealth.com Browser Google Chrome, Microsoft Edge, Internet Explorer and Safari Version of dashboard 1.
WARNING Portable and mobile RF communications equipment can affect the performance of the Smartz™ system. Install and use the system according to the information contained in this manual.
Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 43
Appendix B Smartz Accessories Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 44
5.0 Appendix B: Accessories 6.2 Smartz™ node Smartz™ node and Mesh Network Overview A smart device with the installed Smartz™ application can pick up the short-range Bluetooth signals from the pod but does send data via Wi-Fi for data to display later on the dashboard. A Smartz™ node is used to convert the Bluetooth single with a slightly more extended range and transmits this signal via a Wi-Fi signal or via an Ethernet cable to the internet.
Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 46
Smartz™ node specifications The Smartz™ node is an off-the-shelf hardware, customised firmware accessory.
SMARTZTM SYSTEM MANUFACTURER DECLARARTION FCC COMPLIANT STATEMENT Changes or modifications not expressly approved by Simavita could void the user's authority to operate the equipment. This device complies with Part 15 of FCC Rules.
SECTION 7 Glossary Smartz™ User Manual | Product Code: 02864 | Model Number: 9000 | Document Number: SAS_GEN1_0039 | Revision: 04 | Date of Issue: 15-July-2020 49
7.
MADE IN AUSTRALIA by Simavita Ltd., Suite 2.02, Level 2, 54 Miller St, North Sydney, NSW 2060, Australia. See www.Smartz™health.com for more information.
