Simavita Smartz Bedienungsanleitung

SIM™ User Manual | Prod Code: 02579_03 | Version: 3a

Smartz User Manual | Prod Code: 02864_2

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.

Smartz User Manual | Prod Code: 02864_2

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

Smartz User Manual | Prod Code: 02864_2

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

Smartz User Manual | Prod Code: 02864_2

SECTION 1

SAFETY

INFORMATION

Smartz User Manual | Prod Code: 02864_2

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.

Smartz User Manual | Prod Code: 02864_2

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.

Smartz User Manual | Prod Code: 02864_2

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.

Smartz User Manual | Prod Code: 02864_2

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

Smartz User Manual | Prod Code: 02864_2

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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