sorin SMARTVIEW KA960 User manual

ENGLISH – 1
TABLE OF CONTENTS
1. Introduction.................................................................................5
2. Indication.....................................................................................5
3. Warnings and precautions.........................................................5
3.1. Warnings...........................................................................5
3.2. Sa ety Precautions ...........................................................6
3.3. Precautions or sa e operation .......................................6
4. amiliarise yoursel with your SMARTVIEW monitor ..............7
4.1. Package contents.............................................................7
4.2. Description........................................................................8
4.3. Meaning o the lights and buttons..................................9
5. Using your SMARTVIEW monitor .............................................10
5.1. Setting-up your SMARTVIEW monitor ...........................10
5.2. Complete the installation with communication
setup..................................................................................12
5.3. Operational usage............................................................13
5.4. On-demand operation......................................................13
6. Travelling.....................................................................................13
7. Moving home...............................................................................14
8. SMARTVIEW monitor basic care...............................................14
9. Maintenance and Recycling ......................................................14
10. FAQ ..............................................................................................15
11. Technical speci ications ............................................................16
12. Data protection ...........................................................................17
13. Declaration o con ormity ..........................................................17

2 – ENGLISH
14. Guidance and manu acturer’s declaration...............................19
14.1. Electromagnetic emissions.............................................19
14.2. Electromagnetic immunity ..............................................20
14.3. Recommended separation distances between
portable and mobile RF communications
equipment and the SMARTVIEW monitor......................23
15. Technical assistance....................................................................24

ENGLISH – 3
LIST OF SYMBOLS
This symbol is used to encourage you to consult the documentation and
manual enclosed in the pac aging.
This symbol confers the approval of the US Federal Communications
Commission.
This symbol indicates that the device meets UL requirements.
Remote Cardiac Monitor (Medical Equipment) WITH RESPECT TO ELECTRIC
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
IEC 60601-1, CAN/CSA 60601-1, ANSI/AAMI ES 60601-1.
Name and address of the manufacturer
Serial number
Temperature limits
Atmospheric air-pressure limits
Direct current
This symbol indicates the phone line connection.

4 – ENGLISH
This electronic product is subject to disposal and recycling regulations that vary
by country and region.
Many countries prohibit the disposal of waste electronic equipment in standard
waste receptacles. For more details, please refer to the European Directive
2002/96/CEE.
IP21
Degree of protection provided by the enclosure
SYMBOLS USED IN THIS MANUAL
This icon is used to call your attention to a particularly
important point.
This icon alerts you to a hazard that may result in
equipment damage or personal injury. Carefully read
the instructions provided with this icon.
ABOUT THIS MANUAL
Your doctor should be your first source of information regarding your health.
This manual addresses many of the questions you or your family may
have about your SMARTVIEW monitor and its use.
If you have technical or usage questions that are not covered in this manual
or you want more in-depth information, please contact the Sorin CRM toll-
free technical assistance.

ENGLISH – 5
1. INTRODUCTION
The SMARTVIEW monitor you received is part of the SMARTVIEW Remote
Monitoring System. This system has been specially designed to transmit
information stored in your Sorin CRM implanted cardiac device to your
doctor on a regular basis. Your Sorin CRM cardiac device is equipped with a
transmitter which sends clinical information and device parameters to your
doctor through the SMARTVIEW monitor using Radio Frequency wireless
technology. The data retrieved by your SMARTVIEW monitor is routed
through the phone line, synthesized and reported to your doctor.
The SMARTVIEW Remote Monitoring System designed by Sorin CRM
is a fully automated system which does not need any specific
interaction in operational mode. It can, however, also be used manually
but only on your doctor’s instruction.
2. INDICATION
The SMARTVIEW monitor is designed for use with:
−the Sorin CRM radio frequency implanted cardiac device only.
−any household traditional (analog type) telephone land line. It will
not operate with other lines such as and not limited to digital, ADSL
or optical.
3. WARNINGS AND PRECAUTIONS
3.1. WARNINGS
If at any time you feel that you need a fast response,
CALL YOUR LOCAL EMERGENCY SERVICE
IMMEDIATELY.
The SMARTVIEW Remote Monitoring System is not
intended as an emergency response system.

6 – ENGLISH
3.2. SAFETY PRECAUTIONS
Alteration – Your SMARTVIEW monitor and supplied accessories shall
not be modified, altered, or changed in any way without signed written
permission from SORIN. Unauthorized modification may void the
equipment authorization from the FCC and will void the SORIN
warranty. Use only Sorin CRM supplied accessories.
Keep Children Away – Do not let children touch the SMARTVIEW
monitor.
Environmental actors - To reduce the ris of fire, electric shoc and
personal injury, do not expose this appliance to rain, moisture or
extreme temperatures and avoid any installation or On-Demand
operation during an electrical storm. If the SMARTVIEW monitor is
damaged due to a shoc or liquid exposure, do not plug it in again and
call our toll-free technical assistance.
3.3. PRECAUTIONS FOR SAFE OPERATION
Location – Preferably the SMARTVIEW monitor should be placed in a
stable position on the nightstand of the patient, as close as possible to
the side of the bed the patient usually sleeps.
Power supply – The SMARTVIEW monitor should be connected
exclusively to a Sorin CRM power adaptor.
Power supply protection – Power adaptors should be routed so they
are not li ely to be wal ed on or pinched by items placed on or against
them.
Power supply disconnection – The power soc et must be near the
SMARTVIEW monitor and easily accessible. You can only remove power
from the SMARTVIEW monitor by disconnecting the power adaptor from the
outlet. Always carefully disconnect all plugs by pulling on the plug and not on
the cord.

ENGLISH – 7
Inter erences – The SMARTVIEW monitor can be influenced by other
household appliances (such as alarm cloc , mobile phone). If possible, you
should avoid placing electrical appliances next to the SMARTVIEW monitor.
Check button - Do not press the Chec button on the bottom of the
transmitter unless requested to do so by our toll-free technical
assistance.
4. FAMILIARISE YOURSELF WITH YOUR
SMARTVIEW MONITOR
4.1. PACKAGE CONTENTS
Inside the box you will find:
1 SMARTVIEW
monitor
User’s manual
1 Power adaptor 1 RJ11
Telephone cable
(5 meters)

8 – ENGLISH
Do not use any other parts than the ones supplied with
the SMARTVIEW monitor, as this may result in
increased emissions or decreased immunity of the
equipment.
4.2. DESCRIPTION
A/ On-Demand button
B/ Progress bar
C/ Status light
D/ Telephone ports 1 and 2
E/ Power supply inlet
(cable with the orange mar )

ENGLISH – 9
4.3. MEANING OF THE LIGHTS AND BUTTONS
Light or button State Colour Meaning
OFF No colour The SMARTVIEW monitor is not
properly plugged in or not connected to
the telephone networ . Please chec
the connections. If the status light
remains off, please contact our toll-free
technical assistance.
Constant
amber
You have just connected the
SMARTVIEW monitor to the wall
soc et. The SMARTVIEW monitor is
setting up. Please wait. This process
ta es less than 5 minutes.
Status light
ON
Constant
green
The SMARTVIEW monitor is operational.
Green The SMARTVIEW monitor is gathering
data. Stay as close as possible to the
SMARTVIEW monitor and don’t
disconnect it.
On-Demand button Flashing
Red The SMARTVIEW monitor could not gather
the information stored in your implanted
defibrillator. Come closer to the
SMARTVIEW monitor and restart the
process. If the button turns red again, please
contact our toll-free technical assistance.
ON Green You pushed the button to request an On-
Demand transmission. The SMARTVIEW
monitor is chec ing that the function is
active before performing the transmission.
Progress lights Progress Green The SMARTVIEW monitor is gathering
information from your implanted
defibrillator. Stay as close as possible
to the SMARTVIEW monitor and don’t
disconnect it.

10 – ENGLISH
5. USING YOUR SMARTVIEW MONITOR
The Sorin CRM SMARTVIEW monitor wor s automatically. Therefore, you
will have no interaction with it except at installation and only on your doctor’s
request.
5.1. SETTING-UP YOUR SMARTVIEW MONITOR
In order to perform the installation of your SMARTVIEW monitor in a quic ly,
easily and safely way, we recommend you to call our technical assistance
(see toll-free phone numbers at the end of this manual). Our technicians will
assist you. It is free and ta es little time.
Step Operation
1 Ta e all the items out of the box.
2 Place your SMARTVIEW monitor in a stable position,
preferably on your nightstand, as close as possible to the
side of the bed you usually sleep on.
3 To connect the SMARTVIEW monitor to the phone line:

ENGLISH – 11
wall socket, use the Sorin CRM blac telephone cable to
connect the SMARTVIEW monitor to the telephone wall
soc et as shown in the picture below:
- i your phone is already plugged into the telephone wall
socket, unplug your own telephone cable from the telephone
wall soc et and plug it into one of the telephone ports at the
bac of the SMARTVIEW monitor. Use the Sorin CRM blac
telephone cable to connect the SMARTVIEW monitor to the
wall soc et as shown in the picture below:

12 – ENGLISH
4 Remove the power adaptor from the little white box and
plug the end of the cable with the orange mar into the
appropriate inlet in the SMARTVIEW monitor identified
with the same orange mar .
5 Plug the power supply bloc into the mains. A green light
turns ON immediately on this bloc .
6 You should observe the following:
The status light turns stable amber for around 45 seconds
and then turns green. Your SMARTVIEW monitor is now
ready for the next step: Communication.
7 The On-Demand button is now flashing green. It will continue
flashing as long as you do not press this button.
To operate properly, your SMARTVIEW monitor
should always be connected to your phone line and
the main power outlet.
5.2. COMPLETE THE INSTALLATION WITH
COMMUNICATION SETUP
At this stage, your SMARTVIEW monitor will need to “tal ” with your
Sorin CRM implanted device. You will not feel anything as it is fully
independent of your clinical treatment.
Press the On-Demand button gently until you feel a clic . You will see
the On-Demand button constant green for between 30 seconds and 1
minute. Wait until the green light turns completely OFF.
Your SMARTVIEW monitor is fully operational and your doctor has
already been notified that the installation has run successfully. Your
Sorin CRM implanted device is now being monitored.

ENGLISH – 13
The communication setup is requested at first
installation only. Disconnecting and reconnecting the
SMARTVIEW monitor does not require setting up the
communication again.
5.3. OPERATIONAL USAGE
In order to reduce any inconvenience, your SMARTVIEW monitor is set
up to read your Sorin CRM implanted device at night while you sleep.
If the status light is OFF, chec all connections. If the problem persists,
call our toll-free technical assistance..
During the transmission, your phone line will be busy.
Should you need to use your phone for emergency
reasons, temporarily unplug your SMARTVIEW monitor.
Should you be on the phone while the SMARTVIEW
monitor gathers data, you may hear some noises or
disruptions on the phone line.
5.4. ON-DEMAND OPERATION
Your doctor may as you to press the On-Demand button. Follow his
instructions closely, but do not use this button unless your doctor requests it.
6. TRAVELLING
If you are planning to travel, you should inform your doctor of your dates of
absence. Some of the scheduled events may need to be temporarily changed.
To now whether your SMARTVIEW monitor will
operate in the country where you travel, please call
our toll-free technical assistance who will give you
relevant instructions.

14 – ENGLISH
7. MOVING HOME
If you move home, you will have to re-install your SMARTVIEW monitor in
your new home by following the installation procedure. Please call our toll-
free technical assistance.
8. SMARTVIEW MONITOR BASIC CARE
Your SMARTVIEW monitor has been designed to successfully pass the
safety and regulatory standards. To ensure that it wor s, always protect your
SMARTVIEW monitor from being splashed with any ind of liquid. If you
need to clean it, please use only a soft dry cloth. Any other cleaning method
could damage your SMARTVIEW monitor. Do not use any ind of
detergents even dry ones.
9. MAINTENANCE AND RECYCLING
Your SMARTVIEW monitor remains property of Sorin CRM.
It requires no maintenance.
As with all electronic devices recycling your SMARTVIEW monitor is
mandatory, therefore please return it to Sorin CRM if you do not use or
need it anymore.
Please contact our toll-free technical assistance for more information on
the collecting procedure. Sorin CRM will be in charge of collecting and
recycling it in compliance with European Directive 2002/96/CEE.

ENGLISH – 15
10. FAQ
Why do I need to be monitored?
You have been advised to install Sorin CRM's SMARTVIEW monitor in your
home so that your doctor can closely follow your heart disease and identify
potential needs for adjustments to your treatment. Should you have any
questions or need further information, please contact your doctor.
What shall I do i I do not eel well?
When experiencing symptoms, you should call your doctor or your local
emergency service. Our technology does not replace them under any
circumstances.
Is there a risk due to Radio Frequency?
No, because the SMARTVIEW monitor has successfully passed the
security tests regarding normative level of radiation.
Does the communication cost me anything?
The communication won’t cost you anything within the country where
the first connection has been initiated.
Our SMARTVIEW monitor uses toll-free phone numbers to transfer
information to your doctor. If you use the SMARTVIEW Monitor abroad
then communication costs will not be covered by Sorin CRM.

16 – ENGLISH
11. TECHNICAL SPECIFICATIONS
If you suspect any ind of default, please call our toll-free technical
assistance. Our technicians will help you and run investigations if needed.
Part number KA960
Dimensions Height: 59 mm
Width: 156 mm
Depth: 122 mm
Weight 250 g
Power supply AC input : 100-240 V~ 50-60 Hz 250 mA
(to wall soc et)
Operating conditions from 0°C to +40°C
from 5% to 93% RH non condensing
Transport and storage
conditions
from -15°C to +70°C
from 5% to 95% RH non condensing
Atmospheric air-pressure
limits
Min: 700 hPa
Max: 1060 hPa
IP21 Degree of protection provided by the enclosure
Transmitter requency 2400-2483 MHz (ISM)
402-405 MHz (MedRadio)
Characteristics o the
transmitters
ISM: uses frequency hoping,
ERP = 100 mW max, OOK modulation.
MedRadio: uses Listen Before Tal algorithm, ERP =
25 µW max, FSK modulation.
Receiver requency 402-405 MHz (MedRadio)

ENGLISH – 17
Modem Standard ITU-T V.92/V.90/56K Soc etModem module
for PSTN subscriber line.
Telecom approved in more than 50 countries.
The SMARTVIEW monitor may be interfered with by other equipment, even
if that other equipment complies with CISPR emission requirements.
12. DATA PROTECTION
Any clinical data is fully secured with restricted access. You have the
right to access this information at any time and as for any change by
request only. Please contact your doctor or our toll-free technical
assistance.
13. DECLARATION OF CONFORMITY
Sorin CRM declares that this device:
−is in conformity with the essential requirements of Directive 1999/5/EC on Radio and
Telecommunications Terminal Equipment, with the mutual recognition of their conformity
(R&TTE) and with the Directive 90/385/EEC on Active Implantable Medical Devices and,
−carries the CE mar ing accordingly.
Sorin CRM declares that this device conforms to the following Product Specifications:
Sa ety - IEC 60601-1:2005 (Ed. 3) - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
EMC -IEC 60601-1-2:2007 (Ed. 3) - Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and Tests.
EN 50371:2002 - Generic standard to demonstrate the compliance of low power electronic and
electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields
(10 MHz - 300 GHz).
EN 50385:2002 - Product standard to demonstrate the compliance of radio base stations
and fixed terminal stations for wireless telecommunication systems with the basic restrictions
or the reference levels related.
EN 301 489 v1.8.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
Electromagnetic Compatibility (EMC) standard for radio equipment and services.

18 – ENGLISH
Federal Communication Commission Inter erence Statement 47 CFR Section 15.105(a)
- The FCC Product ID is YSGKA960.
This equipment has been tested and found to comply with the limits for a Class B or A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try to correct
the interference by one of the following measures:
−Reorient or relocate the receiving antenna.
−Increase the separation between the equipment and receiver.
−Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
−Consult the dealer or an experienced radio/TV technician for help.
FCC Inter erence Statement 47 CFR Section 15.21 - No Unauthorized Modi ications
CAUTION: This equipment may not be modified, altered, or changed in any way without
signed written permission from SORIN. Unauthorized modification may void the equipment
authorization from the FCC and will void the SORIN warranty.
Identi ication o the equipment according Section 2.925 and 15.19 (a)(1)
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.
This device may not interfere with stations operating in the 400.150–406.000 MHz band in
the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services
and must accept any interference received, including interference that may cause undesired
operation.

ENGLISH – 19
14. GUIDANCE AND MANUFACTURER’S
DECLARATION
14.1. ELECTROMAGNETIC EMISSIONS
The SMARTVIEW monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the SMARTVIEW monitor should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The SMARTVIEW monitor uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not li ely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/ flic er emissions
IEC 61000-3-3
Complies
The SMARTVIEW monitor is suitable for use in
all establishments, including domestic
establishments and those directly connected to
the public low voltage power supply networ that
supplies buildings used for domestic purposes.

20 – ENGLISH
14.2. ELECTROMAGNETIC IMMUNITY
The SMARTVIEW monitor is intended for use in the electromagnetic environment specified below.
The user of the SMARTVIEW monitor should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 V contact
± 8 V air
± 6 V contact
± 8 V air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least
30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 V for power
supply lines
± 1 V for
input/output lines
± 2 V for
power supply
lines
± 1 V for
input/output
lines
Mains power quality
should be that of a
typical home
environment.
Surge
IEC 61000-4-5
± 1 V line(s) to
line(s)
± 2 V line(s) to
earth
± 1 V line(s) to
line(s)
± 2 V line(s) to
earth
Mains power quality
should be that of a
typical home
environment.