SORIN CRM KA351 The Orchestra Plus Link User Manual TABLE OF CONTENTS

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Document Author:	Anne Couturier

ORCHESTRA PLUS LINK
USER MANUAL
KA 351
TABLE OF CONTENTS
1. List of symbols ..........................................................................................................................................................................................2
2. Symbols used in this manual ...................................................................................................................................................................3
3. Introduction ................................................................................................................................................................................................4
4. User Profile.................................................................................................................................................................................................5
5. Indication ....................................................................................................................................................................................................6
6. Warnings and precautions .......................................................................................................................................................................7
6.1 Safety Precautions ..........................................................................................................................................................................7
6.2 Precautions for safe operation ......................................................................................................................................................7
7. Package contents ......................................................................................................................................................................................8
8. Description .................................................................................................................................................................................................9
9. Using ORCHESTRA PLUS LINK .............................................................................................................................................................10
9.1 Setting-up ORCHESTRA PLUS LINK...........................................................................................................................................10
9.2 Using the ORCHESTRA PLUS LINK ............................................................................................................................................10
9.3 Ensuring stable RF Communication ...........................................................................................................................................11
9.4 ORCHESTRA PLUS LINK software update .................................................................................................................................11
10. ORCHESTRA PLUS LINK basic care .....................................................................................................................................................12
11. Maintenance and Recycling ...................................................................................................................................................................13
11.1. Compatibility .................................................................................................................................................................................13
12. Troubleshooting ......................................................................................................................................................................................14
13. Technical specifications .........................................................................................................................................................................15
14. Declaration of conformity .......................................................................................................................................................................16
15. Guidance and manufacturer’s declaration ...........................................................................................................................................19
15.1 Electromagnetic emissions..........................................................................................................................................................19
15.2 Electromagnetic immunity ...........................................................................................................................................................19
15.3 Recommended separation distances between portable and mobile RF communications equipment and the
ORCHESTRA PLUS LINK .............................................................................................................................................................20
16. Technical assistance ...............................................................................................................................................................................21
1. LIST OF SYMBOLS
1. LIST OF SYMBOLS
This symbol is used to encourage you to consult the documentation and manual enclosed
in the packaging.
FCC icon
This symbol confers the approval of the US Federal Communications Commission.
Name and address of the manufacturer
Serial number
Keep the device dry. Keep it away from liquids and do not spill or drip water on it.
The monitor shall be powered only with direct current.
Non-ionizing magnetic radiation
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.
Temperature limits for storage and transportation
Humidity limits for storage and transportation
Pressure limits for storage and transportation
Sorin Reference of the ORCHESTRA PLUS LINK
USB Type A Power supply connector to Orchestra Plus
FCC ID : YSGKA351
IC ID: 10270A-KA351
SORIN - ORCHESTRA PLUS LINK – U386A
2. SYMBOLS USED IN THIS MANUAL
2. 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
If you have technical or usage questions that are not covered in this manual or you want
more in-depth information, please contact your sales representative.
SORIN – ORCHESTRA PLUS LINK – U386A
3. INTRODUCTION
3. INTRODUCTION
The ORCHESTRA PLUS LINK is part of the RF Programmer System. This system has been
specially designed to program and interrogate Sorin Radio Frequency implantable medical
devices.
Sorin cardiac devices are equipped with a transceiver which receives clinical commands and
sends clinical information and device parameters through the ORCHESTRA PLUS LINK
Radio Frequency wireless technology.
This manual does not explain how to use the SmartView programming
software; please refer to the online help.
SORIN - ORCHESTRA PLUS LINK – U386A
4.
USER PROFILE
4. USER PROFILE
Any person who followed the required training based on the local regulation. Training
completion and effectiveness are under his/her medical supervisor’s responsibility.
SORIN – ORCHESTRA PLUS LINK – U386A
5.
INDICATION
5. INDICATION
The ORCHESTRA PLUS LINK is designed for use with:
Sorin Radio Frequency implantable medical devices,
Sorin Orchestra Plus programmer equipped with a Sorin inductive programming
head.
SORIN - ORCHESTRA PLUS LINK – U386A
6. WARNINGS AND PRECAUTIONS
6. WARNINGS AND PRECAUTIONS
6.1
SAFETY PRECAUTIONS
Alteration – Your ORCHESTRA PLUS LINK 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 certified body
(compliance to standards) and compromise system performance. Use only Sorin supplied
accessories.
Environmental factors - To reduce the risk of system failure, fire, personal injury, do not
expose this appliance to humidity, moisture, extreme temperatures or electrical storms. If the
ORCHESTRA PLUS LINK is damaged due to a mechanical shock or liquid, do not plug it in
again and call your sales representative.
Keep the device dry – Do not spill or drip liquids on it.
6.2
PRECAUTIONS FOR SAFE OPERATION
Location – Preferably the ORCHESTRA PLUS LINK should be placed in a stable position
as close as possible to the patient.
Power supply – The ORCHESTRA PLUS LINK shall be connected exclusively to one of
Sorin Orchestra Plus USB ports. Refer to Orchestra Plus user manual for location of ports E
& C (dual ports).
Power supply protection –ORCHESTRA PLUS LINK USB cable shall be routed so it is not
likely to be walked on or pinched by items placed on or against it. In addition, USB cable
extensions shall not be used to connect ORCHESTRA PLUS LINK to Orchestra Plus.
Power supply connection – ORCHESTRA PLUS LINK USB cable shall be plugged into
Orchestra PLUS before interrogating the implantable medical device. It will not be possible
to establish an RF communication with the implantable medical device if the interrogation
starts before the ORCHESTRA PLUS LINK has been connected.
Power supply disconnection – You can only remove power from ORCHESTRA PLUS
LINK by disconnecting its USB cable from Orchestra Plus. Always carefully disconnect
ORCHESTRA PLUS LINK by pulling on the USB plug and not on the cable.
Do not remove the USB cable during the Orchestra Plus programming session of the
implantable medical device.
Interferences – ORCHESTRA PLUS LINK can be subject to disturbances from other
products in the vicinity which emit electromagnetic interference (see Troubleshooting section
10). Keep the space clear between the ORCHESTRA PLUS LINK and the implantable
medical device.
SORIN – ORCHESTRA PLUS LINK – U386A
7. PACKAGE CONTENTS
7. PACKAGE CONTENTS
Inside the box you will find ORCHESTRA PLUS LINK and its user manual (CD-Rom).
Do not use any other parts than those supplied with the ORCHESTRA
PLUS LINK.
SORIN - ORCHESTRA PLUS LINK – U386A
8. DESCRIPTION
8. DESCRIPTION
A/ Functioning status LED
B/ RF link indicator LED
C/ RF signal strength 5 LEDs
D/ USB cable
SORIN – ORCHESTRA PLUS LINK – U386A
9. USING ORCHESTRA PLUS LINK
9. USING ORCHESTRA PLUS LINK
9.1
SETTING-UP ORCHESTRA PLUS LINK
In order to setup ORCHESTRA PLUS LINK, follow the instructions below.
Step
Operation
Install & switch on Orchestra Plus programmer (refer to Orchestra Plus user manual)
Take ORCHESTRA PLUS LINK out of the box.
Place your ORCHESTRA PLUS LINK on a stable and flat surface, (on a trolley, table or
the patient’s bed) as close as possible to the patient.
Plug ORCHESTRA PLUS LINK USB cable into an Orchestra Plus USB port.
Once connected to Orchestra Plus, ORCHESTRA PLUS LINK will automatically run SW
initialization and self-tests for a few seconds (status LED will light-up orange).
Once self-tests have passed, ORCHESTRA PLUS LINK is ready for use.
The status LED becomes green.
9.2
USING THE ORCHESTRA PLUS LINK
To interrogate an implantable medical device compatible with ORCHESTRA PLUS LINK,
follow the instructions below:
Step
Operation
Place the inductive programming head on the implantable medical device and select
the Interrogate button in the Programmer User Interface.
After a few seconds the RF communication will start automatically (if previously
selected in the programmer User Interface)
The RF link indicator will light-up and RF signal strength LEDs will indicate the RF
communication quality.
5 LEDs lit up indicate the optimal communication
Move the inductive programming head away from the implantable medical device once
the RF communication has started
Full interrogation and programming of the implantable medical device can now be
performed via ORCHESTRA PLUS LINK.
Quit the programming session before the patient leaves the operating room or followup.
RF programming communication will be in any case automatically disabled after a time
of inactivity (RF still active for Remote Monitoring).
10
SORIN - ORCHESTRA PLUS LINK – U386A
9. USING ORCHESTRA PLUS LINK
Quitting the programming session reduces battery consumption and
optimizes device longevity.
9.3
ENSURING STABLE RF COMMUNICATION
For stable RF communication between ORCHESTRA PLUS LINK and the implantable
medical device, it is recommended to position ORCHESTRA PLUS LINK in order to light at
least 4 LEDs.
It is highly recommended to obtain stable communication before
performing device tests such as pacing and defibrillation threshold tests.
Keep the space clear between the ORCHESTRA PLUS LINK and the
implantable medical device, and do not cover the implanted device when
performing defibrillation threshold tests.
In some cases the RF communication can be disturbed and disrupted (see Troubleshooting
section 10).
When RF communication is disrupted Orchestra Plus will automatically try to restore it.
During RF communication restoration, the RF link LED will blink.
9.4
ORCHESTRA PLUS LINK SOFTWARE UPDATE
ORCHESTRA PLUS LINK software update, if
any, will start automatically after connection to
Orchestra Plus. (Orchestra Plus shall be on.)
During the update the functioning status LED
is green and the RF signal strength LEDs
indicate the action in-progress by blinking
sequentially.
SORIN – ORCHESTRA PLUS LINK – U386A
11
10. ORCHESTRA PLUS LINK BASIC CARE
10. ORCHESTRA PLUS LINK BASIC CARE
Protect the ORCHESTRA PLUS LINK from splashes. To clean it, please only use a soft dry
cloth. Any other cleaning method could damage the ORCHESTRA PLUS LINK. Do not use
any kind of detergents even dry ones. Do not sterilize.
12
SORIN - ORCHESTRA PLUS LINK – U386A
11. MAINTENANCE AND RECYCLING
11. MAINTENANCE AND RECYCLING
11.1. COMPATIBILITY
For more information about implant Radio Frequency wireless programming compatibility
with ORCHESTRA PLUS LINK, please refer to the implant user manual.
The ORCHESTRA PLUS LINK requires neither maintenance, nor calibration (periodical
electrical test).
As with all electronic devices, recycling the ORCHESTRA PLUS LINK is mandatory,
therefore please return it to Sorin if no longer used.
Please contact your sales representative for more information on the collection procedure.
Sorin will be in charge of collecting and recycling it in compliance with European Directive
2002/96/CEE.
SORIN – ORCHESTRA PLUS LINK – U386A
13
12. TROUBLESHOOTING
12. TROUBLESHOOTING
Start-up problems
If the ORCHESTRA PLUS LINK functioning status LED is not green, verify USB connection
with Orchestra Plus. If the problem persists, call your sales representative.
Unstable or no RF communication with implantable medical device
To recover stable communication:
Verify USB connection with Orchestra Plus
Move the inductive programming head away from the implantable medical device
during the implantation or follow-up session, when the RF session is initiated.
Remove any objects between ORCHESTRA PLUS LINK and implantable medical
device
14
Re-position (5 - 10 cm) or rotate the ORCHESTRA PLUS LINK
Move the ORCHESTRA PLUS LINK closer to the implantable medical device
If none of the above works, switch to inductive telemetry
SORIN - ORCHESTRA PLUS LINK – U386A
13.
TECHNICAL SPECIFICATIONS
13. TECHNICAL SPECIFICATIONS
Part number
KA351
Dimensions
Height: 176 mm
Width: 106mm
Depth: 54,4 mm
Weight
450 g
Power supply
USB input : 5 V / 500mA
Operating
conditions
from 0°C to +35°C
Transport and
storage
conditions
from -20°C to +60°C
Transmitter
frequency
2400-2483 MHz (ISM)
Characteristics of
the transmitters
ISM: uses frequency hopping
Atmospheric pressure: from 700 to 1060 hPa
from 5% to 95% RH (non condensing)
Atmospheric pressure: from 500 to 1060 hPa
402-405 MHz (MedRadio)
EIRP = 10 mW max, OOK modulation.
MedRadio: uses Listen Before Talk algorithm, EIRP = 25 µW max, FSK
modulation.
Receiver
frequency
402-405 MHz (MedRadio)
The ORCHESTRA PLUS LINK may be disturbed by other equipment,
even if said equipment complies with CISPR emission requirements.
SORIN – ORCHESTRA PLUS LINK – U386A
15
14. DECLARATION OF CONFORMITY
14. DECLARATION OF CONFORMITY
Sorin declares that this device conforms to the following Product Specifications:
Safety - IEC 60601-1: 2005 (Ed. 3) - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
EMC - IEC 60601-1-2: 2012 (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 60950-1:2006/A12:2011 - Information technology equipment - Safety -- Part 1: General
requirements.
EN 62311: 2008 - Assessment of electronic and electrical equipment related to human
exposure restrictions for electromagnetic fields (0 Hz to 300 GHz)
EN 301 489-1 v1.8.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
Electromagnetic Compatibility (EMC) standard for radio equipment and services - Part 1:
Common technical requirements.
EN 301 489-1 V1.9.2 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1:
Common technical requirements
EN 301 489-7 V1.3.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific
conditions for Broadband Data Transmission Systems
EN 301 489-17 v2.1.1 - Specific conditions for Broadband Data Transmission Systems.
EN 301 489-27 v1.1.1 - Specific conditions for Ultra Low Power Active Medical Implants
(ULP-AMI) and related peripheral devices (ULP-AMI-P).
EN 300 328 v1.7.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz
ISM band and using wide band modulation techniques; Harmonized EN covering essential
requirements under article 3.2 of the R&TTE Directive.
ETSI EN 301 839-1 v1.3.1 - Electromagnetic compatibility and Radio spectrum Matters
(ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part
1: Technical characteristics and test methods.
ETSI EN 301 839-2 v1.3.1 - Electromagnetic compatibility and Radio spectrum Matters
(ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part
2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive.
Federal Communication Commission Interference Statement 47 CFR Section 15 and
105(b)
16
SORIN - ORCHESTRA PLUS LINK – U386A
14. DECLARATION OF CONFORMITY
The FCC product ID is YSGKA351.
This equipment has been tested and found to comply with the limits for a Class B 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 interference by one or more 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 circuit different from that to which the receiver is
connected.
- Consult the dealer or an experienced radio/TV technician for help.
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 complies with FCC RF radiation exposure limits set forth for general population.
This device must be installed to provide a separation distance of at least 20cm from all
persons and must not be co-located or operating in conjunction with any other antenna or
transmitter.
FCC Interference Statement 47 CFR Section 15.21 - No Unauthorized Modifications
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.
Identification of the equipment according Section 95.1217(a)
This transmitter is authorized by rule under the Medical Device Radiocommunication Service
(in part 95 of the FCC Rules) and must not cause harmful interference to stations operating
in the 400.150-406.00 MHz band in the Meteorological Aids (i.e., transmitters and receivers
used to communicate weather data), the Meteorological Satellite, or the Earth Exploration
Satellite Services and must accept interference that may be caused by such stations,
including interference that may cause undesired operation. This transmitter shall be used
only in accordance with the FCC Rules governing the Medical Device Radiocommunication
Service. Analog and digital voice communications are prohibited. Although this transmitter
has been approved by the Federal Communications Commission, there is no guarantee that
it will not receive interference or that any particular transmission from this transmitter will be
free from interference.
IC Requirements for Canada
The IC product ID is 10270A-KA351.
SORIN – ORCHESTRA PLUS LINK – U386A
17
14. DECLARATION OF CONFORMITY
This class B digital apparatus meets all requirements of the Canadian Interference- causing
equipment regulations.
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.
Under Industry Canada regulations, this radio transmitter may only operate using an
antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry
Canada. To reduce potential radio interference to other users, the antenna type and its gain
should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more
than that necessary for successful communication.
This device complies with Industry Canada RF radiation exposure limits set forth for general
population (uncontrolled exposure). This device must be installed to provide a separation
distance of at least 20cm from all persons and must not be collocated or operating in
conjunction with any other antenna or transmitter.
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.
Cet appareil numérique de la classe B respecte toutes les exigences du règlement sur le
matériel brouilleur du Canada.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils
radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: (1) il
ne doit pas produire de brouillage, et (2) l’utilisateur du dispositif doit être prêt a accepter
tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettre
le fonctionnement du dispositif.
Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour
l’émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage
radioélectrique à l’ intention d’autres utilisateurs, il faut choisir le type d’antenne et son gain
de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l’intensité
nécessaire à l’établissement d’une communication satisfaisante.
Le présent appareil est conforme aux niveaux limites d’exigences d’exposition RF aux
personnes définies par Industrie Canada. Cet appareil doit être installé afin d’offrir une
distance de séparation d’au moins 20cm avec l’utilisateur, et ne doit pas être installé à
proximité ou être utilisé en conjonction avec une autre antenne ou un autre émetteur.
Le présent dispositif ne doit pas causer de brouillage aux stations du service des auxiliaires
de la météorologie, des satellites météorologiques, du service d’exploration de la terre par
satellite, exploitées dans la bande 400,150-406,000 MHz, et il doit accepter tout brouillage
reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif.
18
SORIN - ORCHESTRA PLUS LINK – U386A
15. GUIDANCE AND MANUFACTURER’S DECLARATION
15. GUIDANCE AND MANUFACTURER’S DECLARATION
15.1
ELECTROMAGNETIC EMISSIONS
The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment
specified below. The user of the ORCHESTRA PLUS LINK should ensure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The ORCHESTRA PLUS LINK uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference to nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The ORCHESTRA PLUS LINK is suitable for use in all
clinical establishments, as an accessory of Orchestra Plus
programmer
Harmonic emissions Class A
IEC 61000-3-2
15.2
ELECTROMAGNETIC IMMUNITY
The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment
specified below. The user of the ORCHESTRA PLUS LINK should ensure that it is used in
such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment guidance
Electrostatic
discharge
(ESD)
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
IEC 61000-4-2
The ORCHESTRA PLUS LINK is intended for use in the electromagnetic environment
specified below. The user of the ORCHESTRA PLUS LINK should ensure that it is used in
such an environment.
Portable and mobile RF communications equipment should be used no closer to the
ORCHESTRA PLUS LINK, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
SORIN – ORCHESTRA PLUS LINK – U386A
19
15. GUIDANCE AND MANUFACTURER’S DECLARATION
Recommended separation distance:
3 Vrms
Conducted RF
150 kHz
80 MHz
IEC 61000-4-6
d  1.2 P
to 3 V
3 V/m
Radiated RF
80 MHz
2.5 GHz
IEC 61000-4-3
to 3 V/m
d  1.2 P 80 to 800 MHz
d  2.3 P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should
be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the ORCHESTRA PLUS LINK is used exceeds the applicable RF
compliance level above, the ORCHESTRA PLUS LINK should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting, relocating the ORCHESTRA PLUS LINK, or use inductive telemetry.
15.3
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE ORCHESTRA PLUS LINK
The ORCHESTRA PLUS LINK is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The user of the ORCHESTRA PLUS LINK
can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the ORCHESTRA
PLUS LINK as recommended below, according to the maximum output power of the
communications equipment.
Rated
maximum
output
power of
transmitter
Separation distance according to frequency of transmitter
0.01
0.1
150 kHz
80 MHz
to
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d  1.2 P
d  2.3 P
0.12
0.12
0.23
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
d  1.2 P
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
20
SORIN - ORCHESTRA PLUS LINK – U386A
16. TECHNICAL ASSISTANCE
16. TECHNICAL ASSISTANCE
For any assistance you may need or question you may have about your ORCHESTRA
PLUS LINK, please call your sales representative.
Last revision date of this manual: 2014-10
SORIN – ORCHESTRA PLUS LINK – U386A
21
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
2014-10
U386A
Manufactured in Italy by
Sorin Group Italia S.r.l.
Via Crescentino s.n.
13040 Saluggia (VC) - Italy
Tel: +39 0161 487095
Fax: +39 0161 487524
© 2014 Sorin CRM SAS
Distributed by
Sorin CRM USA, Inc.
14401 West 65th Way
Arvada,CO 80004 - USA
www.sorin.com

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Metadata Date                   : 2014:10:06 14:01:08+02:00
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Document ID                     : uuid:a46c8405-8c56-45f9-b921-f08c86d49d3b
Instance ID                     : uuid:0bfde423-4e95-446b-82d0-cac4465d8fc3
Page Count                      : 24

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