Boston Scientific CRM314013 3140 User Manual

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CRM314013 User Manual

User Manual

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ZOOM® Wireless Transmitter reference guide

TABLE OF CONTENTS

DESCRIPTION AND USE .................................................................................................................................................. 1

INTENDED USE ............................................................................................................................................................... 1

CONTRAINDICATIONS .................................................................................................................................................... 1

WARNINGS ................................................................................................................................................................... 1

Use of unspeci ed cables and accessories ............................................................................................................. 1

Radio interference by other equipment ................................................................................................................ 1

Proximity to other equipment...............................................................................................................................2

ZWT and PRM must remain outside sterile  eld....................................................................................................2

ZWT is MR Unsafe .................................................................................................................................................2

Modi cations ........................................................................................................................................................ 2

PRECAUTIONS ............................................................................................................................................................... 2

Connect only to Boston Scienti c Model 3120 PRM ............................................................................................. 2

Electrical and magnetic interference.....................................................................................................................2

MAINTENANCE AND HANDLING .................................................................................................................................... 3

Cleaning the ZWT ................................................................................................................................................. 3

Magnet handling .................................................................................................................................................. 3

ZWT use ................................................................................................................................................................3

Disconnecting the ZWT .........................................................................................................................................3

ZWT accessibility................................................................................................................................................... 3

ADVERSE EFFECTS ......................................................................................................................................................... 3

SYSTEM FEATURES........................................................................................................................................................ 4

SYSTEM COMPONENTS AND ACCESSORIES .................................................................................................................. 4

SYSTEM SERVICING AND REPAIR .................................................................................................................................. 4

PREPARING THE ZWT FOR USE ...................................................................................................................................... 5

BEGIN ZIP TELEMETRY ................................................................................................................................................... 6

USING THE ZWT ............................................................................................................................................................. 6

Operation ............................................................................................................................................................. 6

Storage ................................................................................................................................................................. 7

MAINTENANCE CHECK AND SAFETY MEASURES ........................................................................................................... 8

Maintenance Check ............................................................................................................................................... 8

Service .................................................................................................................................................................. 8

TROUBLESHOOTING ...................................................................................................................................................... 9

SYMBOLS ON PACKAGING ........................................................................................................................................... 10

ENVIRONMENTAL PROTECTION AND DISPOSAL .......................................................................................................... 11

COMPLIANCE STANDARDS........................................................................................................................................... 12

Safety Standards ................................................................................................................................................. 12

Electromagnetic Compatibility Standards ........................................................................................................... 12

IEC 60601-1-2:2007 Information ........................................................................................................................ 13

Electromagnetic Emissions and Immunity .......................................................................................................... 14

SPECIFICATIONS .......................................................................................................................................................... 20

ENVIRONMENTAL REQUIREMENTS.............................................................................................................................. 21

This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures.

CAUTION: US Federal law restricts this device to sale by or on the order of a physician trained or experienced in device

implant and follow-up procedures.

ZOOM is a registered trademark of Boston Scienti c or its a liates. LATITUDE is a trademark of Boston Scienti c or its a liates.

DESCRIPTION AND USE

The ZOOM® LATITUDE™ Programming System, which includes Model 3120 Programmer/Recorder/Monitor (PRM), Model 3140 ZOOM® Wireless

Transmitter (ZWT), and accessories, is a portable cardiac rhythm management system designed to be used with Boston Scienti c implantable pulse

generators.

INTENDED USE

The ZWT is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scienti c implantable pulse genera-

tors. The PRM software controls all pulse generator communication functions. Refer to model-speci c pulse generator product literature for detailed

information about software application instructions.

CONTRAINDICATIONS

The ZWT is contraindicated for use with any pulse generator other than Boston Scienti c pulse generators. Refer to model-speci c pulse generator

product literature for other contraindications for use.

WARNINGS

Use of unspeci ed cables and accessories

The use of any cables or accessories with the ZWT other than those speci ed by Boston Scienti c in this manual may result in increased emissions or

decreased immunity of the ZWT. Anyone connecting such cables or accessories to the ZWT may be con guring a medical system and is responsible for

ensuring that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for the medical electrical systems.

Radio interference by other equipment

Other equipment may interfere with the ZWT, even if that equipment complies with the International Special Committee on Radio Interference (CISPR)

emission requirements.

Proximity to other equipment

Do not use the ZWT adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, check the ZWT for normal operation in that

con guration.

ZWT and PRM must remain outside sterile  eld

The ZWT and the PRM are non-sterile and cannot be sterilized. They must both remain outside the sterile  eld. Maintain a minimum operating

distance of 7.6 cm (3 in) between the ZWT and the PRM.

ZWT is MR Unsafe

The ZWT is MR Unsafe and must be kept outside MRI sites classi ed Zone III and above, as de ned by the American College of Radiology Guidance

Document for Safe MR Practices . Under no circumstances should the ZWT be brought into the MRI scanner room, the control room, or MRI site Zone III

or IV areas.

Modi cations

No modi cation of this equipment is allowed unless approved by Boston Scienti c.

PRECAUTIONS

Connect only to Boston Scienti c Model 3120 PRM

Connect the ZWT only to a Model 3120 Boston Scienti c PRM equipped with current level software.

Electrical and magnetic interference

Avoid establishing telemetry communication between the ZWT and the pulse generator when the ZWT is in close proximity to monitors,

high-frequency electrosurgical equipment, or strong magnetic  elds. The telemetry link may be impaired.

MAINTENANCE AND HANDLING

Cleaning the ZWT

When necessary, clean the ZWT housing with a soft cloth lightly dampened with water, isopropyl alcohol, a 5% bleach solution, or window cleaner. Do

not allow any amount of cleaning solution or moisture to come in contact with the USB port. Do not use an abrasive cloth or volatile solvents to clean

any portion of the ZWT.

Magnet handling

Do not place a magnet on the ZWT.

ZWT use

The ZWT is not waterproof or explosion-proof and cannot be sterilized. Do not use it in the presence of  ammable gas mixtures including anesthetics,

oxygen, or nitrous oxide.

Disconnecting the ZWT

Disconnect the USB cable from the ZWT unit to completely isolate it from the power source.

ZWT accessibility

Make certain that the USB connection point is accessible at all times so that power may be disconnected.

ADVERSE EFFECTS

None known.

SYSTEM FEATURES

The ZWT enables cordless, hands-free, 2-way radio frequency (RF) communication between the Model 3120 Programmer/Recorder/Monitor (PRM) and

Boston Scienti c pulse generators speci cally designed to use the Medical Implant Communications Service (MICS).

NOTE: The MICS telemetry feature is not available for all pulse generators. For more information, refer to the associated product literature for the pulse

generator being interrogated.

SYSTEM COMPONENTS AND ACCESSORIES

The ZOOM Wireless Transmitter system consists of Model 3140 ZOOM Wireless Transmitter and Model 3141 USB Cable.

CAUTION: The ZWT must be directly connected to either of the two 3120 PRM USB ports using only the Model 3141 USB cable. Do not use USB cables

other than the Model 3141. Intermittent or unreliable telemetry may result if the ZWT is connected to the PRM using an unapproved USB cable.

CAUTION: Do not connect the ZWT to any equipment other than Boston Scienti c Model 3120 PRM.

WARNING: The use of any cables or accessories with the ZWT other than those speci ed by Boston Scienti c in this manual may result in increased

emissions or decreased immunity of the ZWT. Anyone connecting such cables or accessories to the ZWT may be con guring a medical system and is

responsible for ensuring that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems.

SYSTEM SERVICING AND REPAIR

Unless otherwise agreed, the ZWT remains the property of Boston Scienti c and Boston Scienti c must perform all necessary servicing and repair work.

For additional information, contact Boston Scienti c using the information on the back cover.

PREPARING THE ZWT FOR USE

Connect 3140 ZWT and 3120 PRM as shown below. Note

location of indicator light on top surface of ZWT.

The 3120 PRM may be powered on or o during 3140 ZWT installation.

Model 3140 ZWT

Model 3120 PRM

View of left side

ZWT indicator light

BEGIN ZIP TELEMETRY

NOTE: The MICS telemetry feature is not available for all pulse generators. For more information, refer to the associated product literature for the pulse

generator being interrogated.

1. Raise the PRM screen to a comfortable viewing angle.

2. Press the PRM On/O button.

3. Wait until both the PRM startup screen and the ZWT green indicator light appear, usually less than 60 seconds.

4. Place the telemetry wand over the pulse generator. Use either the Quick Start button on the PRM screen or the Select PG button located on

the toolbar below the startup screen to begin interrogation. Remove the wand once the telemetry indicator on the PRM is

illuminated.

For optimum MICS telemetry communication, position the ZWT at least 7.6 cm (3 in) away from the PRM. Remove any obstructions between the two

instruments. Repositioning the ZWT may improve MICS telemetry performance. If MICS telemetry performance is not satisfactory, use the telemetry

wand instead.

USING THE ZWT

Operation

The ZWT requires special handling. To protect the ZWT from damage, refer to the following information:

• Do not subject the ZWT to abusive shocks or vibrations.

• When transporting the ZWT from an outside environment to an inside environment, allow the ZWT to come to ambient temperature before

use.

• Do not place a magnet on the ZWT.

• Do not pour or splash liquid into or onto the ZWT.

• Do not disassemble the ZWT.

• Disconnect the USB cable prior to transporting the ZWT.

Operate the ZWT and accessories within the following conditions:

• Temperature range of 10°C to 35°C (50°F to 95°F)

• Humidity between 25% and 90%

Transport and store the ZWT within the following conditions:

• Temperatures between -40°C and 70°C (-40°F and 158°F)

• Relative humidity between 25% and 95%

• Atmospheric pressure between 50 kPa to 106 kPa (7.252 psi to 15.374 psi)

The ZWT is capable of continuous operation and will not shut o automatically if it is unused for an extended time.

CAUTION:

The ZWT is not waterproof or explosion-proof and cannot be sterilized. Do not use it in the presence of  ammable gas mixtures including anesthetic

mixture with air, oxygen, or nitrous oxide.

Storage

1. Unplug the USB cable.

2. Protect the ZWT and the USB cable from damage.

3. Store the system at -40°C to 70°C (-40°F to 158°F) temperature and 25% to 95% relative humidity.

MAINTENANCE CHECK AND SAFETY MEASURES

Maintenance Check

Prior to each use, perform a visual inspection and verify the following:

• Mechanical integrity of the ZWT and its USB cable.

• Legibility and adhesion of the ZWT labels.

The ZWT contains no user-accessible components and must be returned to Boston Scienti c for repair or replacement of any internal components.

Safety Measurements

National regulations may require that the user, manufacturer, or manufacturer representative periodically perform and document safety tests of the

device. If such testing is required in your country, follow the testing interval and extent of testing as regulated in your country. If you do not know the

national regulations in your country, please contact your local Boston Scienti c representative.

Service

For questions regarding operation or repair of the ZWT, contact Boston Scienti c using the information on the back cover.

The ZWT must be serviced by Boston Scienti c personnel only.

If the ZWT malfunctions and requires repair, help to ensure e cient service by following these guidelines:

1. Leave the con guration of the instrument exactly as it was at the time of malfunction. Contact Boston Scienti c using the information on

the back cover of this manual.

1. Write a detailed description of the malfunction(s).

2. If the ZWT must be returned to Boston Scienti c for service, pack it in the shipping container in which it was received or in a shipping

container provided by Boston Scienti c.

3. Contact Boston Scienti c using the information on the back cover of this manual to obtain the proper ship-to address.

TROUBLESHOOTING

If the ZWT does not operate properly, check that the USB cable is securely connected to both the ZWT and the PRM. Also check that the PRM cords and

cables are free of visible defects and are properly connected. Possible causes and corrective actions for ZWT problems are shown below.

Symptom Possible Cause Corrective Action

Green indicator light on ZWT

does not light within 60 seconds

of powering on PRM

USB cable not securely connected to ZWT

and PRM

Remove and reconnect both ends of USB cable. Reposition

wand over the pulse generator and repeat interrogation.

USB cable damaged Replace with Model 3141 USB Cable only.

ZWT fault Contact Boston Scienti c representative.

Intermittent or no RF telemetry

communication

Telemetry RF signal obstructed Assure that a clear line-of-sight path exists between ZWT

and pulse generator. Repeat interrogation.

Telemetry RF signal interference Reposition or reorient ZWT at least 7.6 cm (3 in) away from

PRM. Repeat interrogation.

USB cable not securely connected to ZWT

and PRM

Remove and reconnect both ends of USB cable. Reposition

wand over the pulse generator and repeat interrogation.

RF Telemetry fails Reposition wand over pulse generator; repeat interrogation.

PRM software version not current Contact Boston Scienti c representative.

SYMBOLS ON PACKAGING

The following symbols may be used on packaging and labeling:

Symbol Description Symbol Description

Reference number Serial number

Lot number Date of manufacture

Non-ionizing electromagnetic radiation Consult instructions for use

Temperature limitation CE mark of conformity with the identi cation of the

noti ed body authorizing use of the mark

Authorized Representative in the European Com-

munity

C-tick with supplier codes

Meets Australia and New Zealand EMC requirements

Australian Sponsor Address Universal Serial Bus (USB)

Symbol Description Symbol Description

RESTRICTED DEVICE. Federal law (USA) restricts the

sale, distribution, or use of this device to, by, or on the

lawful order of a physician

Waste, Electrical, and Electronic Equipment (WEEE).

Discard with electronic waste.

Assembly number This side up

Fragile, handle with care Keep dry

Do not use hooks Humidity limitations

Atmospheric pressure limitations Magnetic Resonance Unsafe

ENVIRONMENTAL PROTECTION AND DISPOSAL

Return the ZWT and accessories to Boston Scienti c at the end of their useful lives for appropriate disposal.

COMPLIANCE STANDARDS

The following standards apply to the ZWT:

Safety Standards

This equipment has been tested and found to comply with applicable safety portions of the following standards:

• IEC 60601-1:2005 + C1:2006 + C2:2007 + INT1:2008 + INT2:2009

• ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2010

• BS EN 60601-1:2006 + C1:2006 + C2:2007 + C3:2010

• CAN/CSA-C22 No. 60601-1-08

Electromagnetic Compatibility Standards

This equipment has been tested and found to comply with the applicable portions of the following electromagnetic compatibility (EMC) standards:

• EN 301 489-1 v1.9.2:2011

• EN 301 489-27 v1.1.1:2004

• EN 301 839-2 v1.3.1:2009

• IC RSS-243:2010

NOTE: Use special precautions regarding EMC during the installation and the use of the ZWT, according to the EMC instructions given throughout this

manual. Refer to the details about the ZWT electromagnetic emissions and immunity.

NOTE: Use caution when using RF portable and mobile equipment in close proximity to the ZWT. Refer to the details about the ZWT electromagnetic

immunity.

FCC: 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 400.150–406.000 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 gov-

erning 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. FCC ID#: ESCCRM314013

Industry Canada: This device complies with Industry Canada license–exempt RSS standard(s). Operation is subject to the following two conditions:

1) this device may not cause harmful interference, and 2) 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–satel-

lite, and earth–exploration satellite services, and must accept any interference received, including interference that may cause undesired operation.

IC# 4794A-CRM31403

CAUTION: Changes or modi cations not expressly approved by Boston Scienti c could void the user’s authority to operate the equipment.

R&TTE: Boston Scienti c hereby declares that this transmitter is in compliance with the essential requirements and other relevant provisions of Direc-

tive 1999/5/EC. To obtain a full text Declaration of Conformity, contact Boston Scienti c using the information on the back cover.

NOTE: As with other telecommunications equipment, verify national data privacy laws.

IEC 60601-1-2:2007 Information

This equipment has been tested and found to comply with the applicable limits for medical devices in ANSI/AAMI/IEC 60601-1-2:2007. This testing

shows the device provides reasonable protection against harmful interference in a typical medical installation. However, there is no guarantee that

interference will not occur in a particular installation.

If this equipment does cause harmful interference to other devices or is negatively impacted by other devices, try to correct the interference by one or

more of the following measures:

• Reorient or relocate the devices

• Increase the separation between the devices

• Connect the equipment to an outlet on a di erent circuit

• Consult the manufacturer or  eld service technician for help

Electromagnetic Emissions and Immunity

The ZWT was determined to have no essential performance. Nevertheless, functions related to communication with the implanted pulse generator

were included in testing.

Table 1: Guidance and manufacturer’s declaration — electromagnetic emissions and environment

Guidance and manufacturer’s declaration – electromagnetic emissions

The ZWT is intended for use in the electromagnetic environment speci ed below. The customer or the user of the ZWT should ensure that it is used

in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions (CISPR 11) Group 1 The ZWT uses RF energy only for its internal function. Therefore,

its RF emissions are very low and are not likely to cause any

interference in nearby electronic equipment.

Guidance and manufacturer’s declaration – electromagnetic emissions

RF emissions (CISPR 11) Class A The ZWT is suitable for use in all establishments other than

domestic and those directly connected to the public low-voltage

power supply network that supplies buildings used for domestic

purposes.

Harmonic emissions (IEC 61000-3-2) Class A

Voltage  uctuations /  icker emissions (IEC 61000-3-3) Complies

Table 2: Guidance and manufacturer’s declaration — electromagnetic immunity and environment

Guidance and manufacturer’s declaration – electromagnetic immunity

The ZWT is intended for use in the electromagnetic environment speci ed below. The customer or the user of the ZWT should ensure 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 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete, or ceramic tile.

If  oors are covered with synthetic material, the

relative humidity should be at least 30%.

Electrical fast transient /

burst (IEC 61000-4-4)

±2 kV for power-supply lines

±1 kV for input/output lines

±2 kV for power-supply lines

±1 kV for input/output lines

Mains power quality should be that of a typical

commercial or hospital environment.

Surge (IEC 61000-4-5) ±1 kV line(s) to line(s)

±2 kV line(s) to earth

±1 kV di erential mode

±2 kV common mode

Mains power quality should be that of a typical

commercial or hospital environment.

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 test level Compliance level Electromagnetic environment –

guidance

Voltage dips, short interrup-

tions, and voltage variations

on power-supply input lines

(IEC 61000-4-11)

<5% UT (>95% dip in UT )

for 0.5 cycleb.

40% UT (60% dip in UT ) for

5 cycles

70% UT (30% dip in UT ) for

25 cycles

<5%UT (>95% dip in UT )

for 5 sec

<5% UT (>95% dip in UT )

for 0.5 cycleb.

40% UT (60% dip in UT ) for

5 cycles

70% UT (30% dip in UT ) for

25 cycles

<5%UT (>95% dip in UT )

for 5 sec

Mains power quality should be that of a typical

commercial or hospital environment. If the user

of the ZWT requires continued operation during

power mains interruptions, it is recommended

that the PRM to which the ZWT is connected be

powered from an uninterruptible power supply

or a battery.

Power frequency (50/60

Hz) magnetic  eld (IEC

61000-4-8)

3 A/m 3 A/m Power frequency magnetic  elds should be at

levels characteristic of a typical location in a typi-

cal commercial or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.

Table 3: Guidance and manufacturer’s declaration — electromagnetic immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The ZWT is intended for use in the electromagnetic environment speci ed below. The customer or the user of the ZWT should ensure that it is used

in such an environment.

Immunity test IEC 60601 test

level Compliance level

Conducted RF

(IEC 61000-4-6)

3 Vrms

150 kHz to 80 MHz 3 Vrms

Radiated RF

(IEC 61000–4-3)

3 V/m

80 MHz to 2.5 GHz 3 V/m

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the ZWT, including cables, than the recommended

separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

√ P

= 1.2 *√ P

= 2.3 *

150 KHz to 80 MHz 80 MHz to 800 MHz 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 meters (m).

Field strengths from  xed 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 a ected by absorption and re ection from structures,

objects, and people.

a. Field strengths from  xed 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

 xed RF transmitters, an electromagnetic site survey should be considered. If the measured  eld strength in the location in which the ZWT is used

exceeds the applicable RF compliance level above, the ZWT should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the ZWT.

b. Over the frequency range 150 kHz to 80 MHz,  eld strengths should be less than 3 V/m.

Table 4: Recommended separation distances between portable and mobile RF communications equipment and the ZWT

The ZWT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the

ZWT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip-

ment (transmitters) and the ZWT as recommended in this table, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

√ P

= 1.2 *

80 MHz to 800 MHz

√ P

= 1.2 *

800 MHz to 2.5 GHz

√ P

= 2.3 *

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed in the table, 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 a ected by absorption and re ection from structures,

objects, and people.

SPECIFICATIONS

Characteristic Nominal

Ingress protection rating IPX0

Dimensions (overall) 17.6 cm (6.9 in) wide, 17.3cm (6.8 in) high, 7.6 cm (3 in) deep

Weight (approximate) .6 kg (1.3 lb)

Power rating 5 V DC

Power cord Power supplied via USB data cable

Duty cycle Continuous

Frequency band 402 – 405 MHz (MICS/MedRadio)

Bandwidth < 300 KHz

Modulation FSK

E ective radiated power 25 μW (-16 dBm)

ENVIRONMENTAL REQUIREMENTS

Characteristic Nominal

Operating temperature 10°C to 35°C (50°F to 95°F)

Transport and storage temperature -40°C to 70°C (-40°F to 158°F)

Operating humidity 25% to 90%

Transport and storage humidity 25% to 95%

Operating altitude <= 2000 m

Transport and storage atmospheric pressure 50 kPa to 106 kPa (7.252 psi to 15.374 psi)

Boston Scientiﬁ c

4100 Hamline Avenue North

St. Paul, MN 55112-5798 USA

Guidant Europe NV/SA; Boston Scientiﬁ c

Green Square, Lambroekstraat 5D

1831 Diegem, Belgium

1.800.CARDIAC (227.3422)

+1.651.582.4000

Boston Scientiﬁ c (Australia) Pty Ltd

PO Box 332

BOTANY NSW 1455 Australia

Free Phone 1 800 676 133

Free Fax 1 800 836 666

manufacturer

representative in the

european community

australian sponsor address

Authorized 2013

*359093-001*

MADE IN CHINA

Boston Scientific CRM314013 3140 User Manual

Boston Scientific Corporation 3140

User Manual

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