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Boston Scientific Latitude 3300, Operator'S Manual

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Boston Scientific Latitude 3300 Operator'S Manual Download Page 69

63

•

ETSI EN 301 489-31 V2.1.1:2016

Radio Spectrum Compliance Standards

The LATITUDE Programming System complies with the applicable portions of
the following radio spectrum compliance standards:

•

ETSI EN 302 195 V2.1.1:2016

•

ETSI EN 300 220-1 V3.1.1:2016

•

ETSI EN 300 220-2 V3.1.1:2016

•

ETSI EN 300 328 V2.1.1:2016

•

ETSI EN 301 839 V2.1.1:2016

•

ETSI EN 301 893 V2.1.1:2017 and ETSI EN 301 893 V1.8.1:2015, Clause
4.8

NOTE:

Use special precautions regarding EMC during the installation and the

use of the LATITUDE Programming System, according to the EMC instructions
given throughout this manual. Refer to the details about the LATITUDE
Programming System electromagnetic emissions and immunity in Table 6
LATITUDE Programming System Nominal Specifications on page 67 and Table
7 Radio Nominal Specifications on page 70.

NOTE:

Use caution when using RF portable and mobile telephony equipment

in close proximity to the LATITUDE Programming System. Refer to the details
about the LATITUDE Programming System electromagnetic immunity in Table
8 Network and Connectivity Specifications on page 71.

Electromagnetic Emissions and Immunity

IEC 60601–1–2:2014 Information

This equipment has been tested and found to comply with the applicable limits
for Class A medical devices in a professional healthcare facility environment to
ANSI/AAMI/IEC 60601-1-2:2014 [or BS EN 60601-1-2:2015 or Active
Implantable Medical Device Directive 90/385/EEC]. 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.

Federal Communications Commission (FCC) Information

This device complies with Title 47, Part 15 of the FCC rules. Operation is
subject to the following two conditions:

•

This device may not cause harmful interference.

•

This device must accept any interference received, including interference
that may cause undesired operation.

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

Summary of Contents for Latitude 3300

Page 1: ...ATOR S MANUAL LATITUDE PROGRAMMING SYSTEM Model 3300 CAUTION Federal law USA restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow up procedures ...

Page 2: ......

Page 3: ...EM ACCESSORIES 13 Optional External Equipment 14 Stand 14 External Printer 15 USB Grounding Plug and Cable 15 External Display 16 CONNECTIONS 16 Patient Side Panel Right Side 17 Physician Side Panel Left Side 17 Indicator Lights 18 STAT Button 18 USING THE LATITUDE PROGRAMMING SYSTEM 18 Preparation for Use 18 Battery Charge Level and Charging 18 Prepare a Telemetry Wand 19 Cable Connections 19 Mak...

Page 4: ...e Tab 35 About Button 36 Selecting a PG 37 Real time Log for Transvenous PGs 39 Real time Log Tools 40 Electronic Calipers 41 Real time Log Events 41 MAINTENANCE 43 Cleaning the Programmer and Accessories 43 Cleaning Cables and Wands 44 Disinfecting the ECG Cable 44 Sterilization 44 Battery Status Installation Replacement and Recycling 45 Battery Replacement 48 Battery Recycling 49 Operation and S...

Page 5: ...adio Spectrum Compliance Standards 63 Electromagnetic Emissions and Immunity 63 IEC 60601 1 2 2014 Information 63 Federal Communications Commission FCC Information 63 LATITUDE PROGRAMMING SYSTEM SECURITY 66 Software 66 Patient Data Management 66 Network 66 Unsupported Hardware 67 Security Vigilance 67 Physical Controls 67 Compromised Programmer 67 SPECIFICATIONS 67 WARRANTY INFORMATION 71 ...

Page 6: ......

Page 7: ...ystem designed to be used with specific Boston Scientific systems i e implantable pulse generators PGs and leads Intended Use The LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems The software in use controls all communication functions for the PG For detailed software application instructions refer to th...

Page 8: ...ion of the LATITUDE Programming System or its applications is required or needed Contraindications The LATITUDE Programming System is contraindicated for use with any PG other than a Boston Scientific PG For contraindications for use related to the PG refer to the associated product literature for the PG being interrogated The PSA application is contraindicated for use with any programming system ...

Page 9: ...uch the patient and any accessible LATITUDE Programming System connector or exposed conductor Electric shock To avoid the risk of electric shock only connect the Programmer s Model 6689 Power Adapter to a grounded earthed power outlet Battery access When accessing the battery ensure that power to the Programmer is turned off Do not touch the connector terminals in the battery compartment while rem...

Page 10: ...s up to one minute there will be no pacing support For this reason a backup PSA pace resource must be available in case electrocautery is applied LATITUDE Programming System location Use of the Model 3300 Programmer adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be ob...

Page 11: ...brillation verify that the Programmer is operating as expected after defibrillation External pacing equipment If the patient is pacer dependent and the Programmer encounters a fault condition pacing operation continues unless the fault was in the PSA component itself For this reason always have external pacing equipment available for patient back up Loss of power Operating the Programmer with a de...

Page 12: ...conduction If the patient has impaired AV conduction AAI programming and antegrade conduction tests must not be performed Abruptly terminating pacing Abruptly terminating pacing may result in extended periods of asystole in some patients Gradually decrease the pacing rate until the patient s intrinsic rate is detected for a controlled transition from pace to intrinsic rhythm Loss of capture Pacing...

Page 13: ...ns If the battery must be shipped contact your local shipper for instructions and shipping requirements PRECAUTIONS General Functional impairment due to external damage Mechanical impact for example dropping the Programmer unpackaged can permanently impair the function of the system Do not use the Programmer if there is apparent damage If damage has occurred contact Boston Scientific to return the...

Page 14: ... directly to the skin pocket or other tissue of the patient Ventricular Sensing During a PSA session ventricular sensing behavior is driven by the most recently selected ventricular pacing configuration RV only LV only or Bi V At system startup the PSA mode is set to ODO non pacing and the effective ventricular pacing configuration is Bi V When a non pacing mode ODO or OVO is selected from the mod...

Page 15: ...e battery To extend Programmer performance refrain from using external devices when on battery power only and the battery level indicator shows 25 or less remaining Software Ensure that you have the latest software versions installed see Software Update Tab on page 35 As a backup your local Boston Scientific representative can provide software updates using a USB pen drive Model 6395 Telemetry Wan...

Page 16: ...Do not use it in the presence of flammable gas mixtures including anesthetics oxygen or nitrous oxide Disconnecting the Programmer To completely disconnect the Programmer from the power source first press and release the power button to turn the system off Then disconnect the power cord from the side of the Programmer Programmer accessibility Ensure that the sides of the Programmer are accessible ...

Page 17: ...grammer to avoid electrical interference Use high quality shielded cables with integral conversions e g DisplayPort to HDMI when possible Minimize the use of active adapters other than those identified by Boston Scientific as they can create emissions that can interfere with PG telemetry Adverse Effects None known SYSTEM CAPABILITIES The LATITUDE Programming System communicates with PGs and provid...

Page 18: ...ams and event markers in PDF format Provides emergency access to STAT SHOCK PG STAT PACE PSA STAT PACE and DIVERT THERAPY functionality applicable to the PG and PSA application Provides ZIP telemetry a cordless hands free RF communication option that allows the Programmer to communicate with the PG Patient Data Management The LATITUDE Programming System provides the ability to print save or transf...

Page 19: ...ocated within the sterile field Model 6697 Remington Model S 101 97 PSA Disposable Cable single use only and requires a Model 6133 Safety Adapter Model 6763 PSA Cable re sterilizable and re usable the cable clip protective covers contain Elastosil R401 silicone rubber Model 6133 Remington Model ADAP 2R Safety Adapter Model 3153 Fixed Patient Leads ECG Cable7 Model 6629 ECG BNC Slave Cable Model 66...

Page 20: ... 16 for medical electrical systems WARNING Do not simultaneously touch the patient and any accessible LATITUDE Programming System connector or exposed conductor CAUTION Although optional external equipment connected to the Model 3300 Programmer must meet the applicable leakage current requirements for commercial products it may not meet the more stringent leakage requirements for medical products ...

Page 21: ...e information USB Grounding Plug and Cable A USB grounding plug and cable may be used with the Model 3300 Programmer to provide an earth ground to decrease noise interference to the LATITUDE Programming System Contact your hospital clinic biomedical engineering department for this standard piece of equipment WARNING The use of any cables or accessories with the LATITUDE Programming System other th...

Page 22: ... provided by or specified by Boston Scientific could result in increased electromagnetic emissions decreased electromagnetic immunity or electrical shock of the LATITUDE Programming System Anyone connecting such cables or accessories to the LATITUDE Programming System including the use of MSOs Multiple Socket Outlets may be configuring a medical system and is responsible to ensure that the system ...

Page 23: ...e Figure 2 Right Side Panel of the Programmer Physician Side Panel Left Side NOTE Equipment connected to the external connections must comply with applicable standards for data processing equipment and for medical equipment 1 Power on off button light gray 2 4 USB 2 0 ports dark gray 5 USB 3 0 port blue 6 Ethernet port orange 7 DisplayPort Out red orange 8 DC power connection for Model 6689 power ...

Page 24: ...ERAPY 1 Red STAT button Figure 4 Front View of LATITUDE Programming System Indicating the Red STAT Button Location USING THE LATITUDE PROGRAMMING SYSTEM Preparation for Use Battery Charge Level and Charging The Lithium ion battery for the Programmer is not charged when shipped To charge the battery perform the following steps NOTE Before using the battery with the LATITUDE Programming System ensur...

Page 25: ...y enclosing the wand in a Model 3320 Sterile Sleeve Model 3203 S ICD Telemetry Wand CAUTION The Model 3203 S ICD Telemetry Wand is shipped non sterile Remove the wand from all packaging material before use If the wand is to be used in a sterile field it must be enclosed in a sterile intraoperative probe cover Model 3320 during use Refer to Cleaning the Programmer and Accessories on page 43 for cle...

Page 26: ...e telemetry communication with the PG always use external power 3 Connect the surface ECG patient cable to the ECG connector Attach the surface electrodes to the patient in a standard three wire or five wire configuration NOTE The ECG function may be sensitive to high frequency ambient noise when the ECG inputs are not attached If the electrodes are not attached to the patient they may be sensitiv...

Page 27: ...e printer before sending files to the printer NOTE The LATITUDE Programming System has Bluetooth capability which can be used to connect with Bluetooth capable printers Refer to the Network and Connectivity Operator s Manual Model 3924 for additional setup and use Information 3 Use the DisplayPort Out connector to attach an external monitor Then ensure that the monitor is connected to external pow...

Page 28: ...associated product literature for the PG being interrogated For PGs that communicate using ZIP telemetry 1 For optimum ZIP telemetry communication position the LATITUDE Programming System within 3 m 10 ft of the PG 2 Remove obstructions between the LATITUDE Programming System and the PG NOTE Reorienting or repositioning the LATITUDE Programming System may improve ZIP telemetry performance NOTE The...

Page 29: ...grammer as much as possible 5 Move the Programmer closer to the patient ideally away from a busy or crowded location in the room 6 Change the Programmer orientation by rotating the Programmer up to 45 degrees clockwise or counter clockwise or by placing the Programmer into the optional Model 6755 Stand 7 Ensure that clinic staff are not in the line of sight between the Programmer and the implanted...

Page 30: ...g system startup observe the screen for any messages If an error message appears do not use the device write a detailed description of the error and contact Boston Scientific using the information on the back cover of this manual 5 When startup is complete the main screen displays Figure 9 Main Screen on page 25 and the system is ready for use The Programmer s touchscreen allows you to select item...

Page 31: ... When complete the main screen displays the following as illustrated in Figure 9 Main Screen on page 25 The status area displays battery charge status and Wi Fi Ethernet and Bluetooth connectivity indicators The lead trace display which can show up to four lead traces for patient assessment such as from a surface ECG or a PSA There are two buttons Snapshot and Real time Recorder at the top of the ...

Page 32: ...may use prior to accessing the application software The About button which allows the user to view print or save to a USB pen drive the LATITUDE Programming System configuration information applications installed on the system and their associated version numbers The Select PG button which allows the desired PG application software to be selected and started and includes the DEMO MODE option for P...

Page 33: ... When in telemetry communication with a high voltage ICD or CRT D PG a pop up displays allowing the user to initiate a PG STAT PACE STAT SHOCK or DIVERT THERAPY command If a PSA session is in progress a PSA STAT PACE option also displays When in telemetry communication with a low voltage PG a pop up displays allowing the user to initiate a PG STAT PACE or DIVERT THERAPY command If a PSA session is...

Page 34: ...RAPY and STAT SHOCK display during a PG session Figure 12 PSA STAT PACE Button Pop up Outside Any PG session with the PSA Application Running If not in a PG session the STAT button brings up the following dialog with no buttons There is no active device session Press Interrogate to initiate the Quick Start function If in a PSA session only no PG interrogated then the same dialogue displays along w...

Page 35: ...hat the PG is not identified Out of range and noise messages display to notify the user that the wand is out of range or telemetry noise is present 3 To proceed with the interrogation session refer to the associated product literature for the PG being interrogated Select PG Button Use the Select PG button at the bottom of the screen to manually interrogate a transvenous PG NOTE The Select PG butto...

Page 36: ...rt diagnostic activities pertaining to implanting programming and monitoring Boston Scientific implantable PGs The LATITUDE Programming System is not intended for use as an ECG monitor or general diagnostic device WARNING Operation of the LATITUDE Programming System with physiological signals that are lower than the minimum detectable amplitude may cause inaccurate results ECG Full Screen Display ...

Page 37: ...m management devices The PSA application displays real time EGM traces and event markers for each enabled channel Real time EGMs display on the same screen as the surface ECG which includes a heart rate indicator Refer to the Pacing System Analyzer PSA Operator s Manual Model 3222 for additional information on how to use the PSA application of the LATITUDE Programming System Model 3300 Patient Dat...

Page 38: ...d typically from a keyboard window To enter data from a keyboard window first select the appropriate value box A keyboard window will appear Touch the first character of the new value it will appear in the data entry box in the graphic keyboard Continue until the entire new value appears in the box To delete one character at a time starting with the last character select the left arrow key on the ...

Page 39: ...ure 15 SELECT PG MODE Demo Pop up ICD CRT D Selected Figure 16 PG Demo Mode The main application screen displays with the demo mode message and DEMO MODE logo at the top of the screen as illustrated in Figure 16 PG Demo Mode on page 33 The software application screens displayed during the demo mode reflect the features and programmable values of the PG family selected To exit the demo mode select ...

Page 40: ...try or ZIP telemetry if it is approved for use in your geography As indicated in Figure 17 Utilities on page 34 ZIP telemetry may not be enabled the button is grayed out If needed contact Boston Scientific using the information on the back cover of this manual to have a representative enable ZIP telemetry Date and Time Tab The Date and Time tab is used to select the TIME ZONE for the Programmer Th...

Page 41: ...tes The user may choose from downloading and installing all updates or reviewing and selecting updates from those available Updates are delivered online via the Internet In addition updates may be supplied on USB pen drives Contact your local Boston Scientific representative using the information on the back cover of this manual for additional details concerning software updates on a USB pen drive...

Page 42: ...grammer will restart reboot NOTE Allow the Programmer to fully restart because an update confirmation will be sent via the network to Boston Scientific indicating a successful software install Offline Updates The Programmer can be updated via a special Software Install8 USB pen drive When the software installation completes an offline update power the Programmer off and back on to complete the pro...

Page 43: ...m information known as the About report From the About screen see Figure 20 About Screen on page 37 select a printer USB or Bluetooth number of copies and then select the Print button NOTE The printer USB or Bluetooth selected in the Patient Data Management application Model 3931 is the printer that displays in the About screen NOTE If no printer is available the About report can still be saved to...

Page 44: ...ECT PG Screen on page 38 then select the Interrogate button in the message pop up as illustrated in Figure 22 SELECT PG MODE on page 38 Once Interrogated the application loads checks system status and then displays the Summary screen Figure 23 Summary Screen on page 39 for the chosen device therapy ...

Page 45: ... press 10 seconds after and 2 seconds before Press once to start and again to stop Real time Log the Real time Recorder button records continuously upon button press and stores data in 3 minute segments until a second press ceases recording While recording is in progress the icon blinks to reflect that storage is ongoing Up to 100 individual recordings can be maintained during a session In the eve...

Page 46: ... Log can be customized using the tools in the Real time Log Tools pop up The Electronic Calipers at the bottom of the screen can be adjusted to measure the desired time span Real time Log Tools Select any part of the Real time Log Event display and the Tools pop up displays as in Figure 25 Real time Log Event Trace Example on page 40 At the top center of the pop up is an arrow and a target icon Wh...

Page 47: ... Calipers Use the Electronic Calipers slide bar to adjust the time span of the Snapshot trace The time interval between the calipers is measured in seconds A caliper can be repositioned by selecting it and then dragging it to expand or collapse the time frame For detailed instructions on using the Electronic Calipers refer to the associated product literature for the PG being interrogated Real tim...

Page 48: ... Commanded 43 Ventricular PES PES Commanded 24 Atrial PES PES Commanded 24 PG Ventricular Burst Pacing PG Burst Completed 24 PG Atrial Burst Pacing PG Burst Completed 24 PG Ventricular 50 Hz Burst Pacing PG Burst Completed 24 PG Atrial 50 Hz Burst Pacing PG Burst Completed 24 PG Fault PG Fault Occurred 12 PSA events are automatically labeled and stored These event types are listed in Table 2 PSA E...

Page 49: ... cleaning solution or moisture to come in contact with the speaker or microphone openings on the bottom front of the Programmer Figure 26 Microphone and Speaker Openings The cables and the wands used with the LATITUDE Programming System are not sterile when packaged Only the Model 6763 PSA cable and the Model 6395 Telemetry Wand can be sterilized All other cables and the Model 3203 S ICD Telemetry...

Page 50: ...ICD Telemetry Wand NOTE Discard the PSA and ECG cables and wands any time surface cracks appear in the cables and or the cables discolor become visibly worn or if labeling becomes unreadable See Environmental Protection and Disposal on page 59 for disposal information Disinfecting the ECG Cable When necessary disinfect the ECG cable using a 2 glutaraldehyde solution such as Cidex a bleach solution...

Page 51: ...elapse prior to use Only FDA cleared pouches should be used during sterilization processing Only the Model 6763 PSA cable may be steam sterilized Parameter Value gravity sterilizers Value dynamic air removal sterilizers Temperature 121 ºC 249 8 ºF 132 ºC 269 6 ºF Steam dwell time 30 minutes 4 minutes Drying time9 15 minutes 20 minutes Number of sterilization cycles permitted 50 50 Battery Status I...

Page 52: ...ld last for approximately two hours of normal operation Figure 27 Battery Status Indicator on Main Screen with AC Power On Battery color 10 is red 10 24 is yellow 25 100 is green Figure 28 Battery Status Icons Indicating Charge Percentage An attention message displays on the Programmer screen when the battery reaches 25 depletion When the battery reaches 10 depletion or less a warning message disp...

Page 53: ...e battery which indicate the remaining charge in 25 increments from 100 75 50 and 25 See Figure 31 Replaceable Programmer Battery representative image on page 48 1 Battery release button 2 Direction to slide cover for removal reverse the direction to replace the cover Figure 30 Battery Compartment on Underside of the Programmer ...

Page 54: ...l stand unclip the stand and remove it 4 Place the device screen side down on a soft cloth 5 Press and hold the battery release button then slide back the battery cover as illustrated in Figure 30 Battery Compartment on Underside of the Programmer on page 47 6 Release the battery retaining strap as identified in Figure 31 Replaceable Programmer Battery representative image on page 48 7 Lift out th...

Page 55: ...to AC power the battery will charge The Programmer does not have to be powered on to recharge the battery However the Programmer must be turned on in order to check the battery charge status see Figure 9 Main Screen on page 25 NOTE For best results be sure to charge the battery to 100 before using the Programmer on battery power only Battery Recycling Boston Scientific recommends that the Lithium ...

Page 56: ...free from obstruction Operating and transport conditions are listed in LATITUDE Programming System Nominal Specifications on page 67 If the LATITUDE Programming System has been stored outside of its normal operating conditions let it sit at ambient temperature until it comes up to operating temperature range before use While the Programmer is in operation the fan will automatically turn on and off...

Page 57: ...h accessory s product literature for transport and storage conditions Ensure each accessory is maintained within the appropriate limits Long Term Storage of the LATITUDE Programming System If the Programmer is to be stored for long periods e g months remove the battery to prevent it from discharging to a point where recharging would be required in order to use it again See Battery Status Installat...

Page 58: ...erform safety testing using the direct method as specified in IEC EN 62353 at an interval of every 24 months or as per local regulations Refer to Compromised Programmer on page 67 Service For questions regarding operation or repair of the LATITUDE Programming System contact Boston Scientific using the information on the back cover of this manual The LATITUDE Programming System must be serviced by ...

Page 59: ... Use correct LATITUDE Programming System for the PG being interrogated Contact Boston Scientific using the information on the back cover of this manual to confirm PG and Model 3300 Programmer compatibility Incorrect telemetry wand Use only the Model 6395 Telemetry Wand for transvenous PGs Poor connection between a telemetry wand and the Programmer Disconnect and reconnect the Model 6395 Telemetry ...

Page 60: ...g USB devices Repeat interrogation RF Telemetry fails Reposition the Model 6395 Telemetry Wand over the transvenous PG and repeat interrogation Use the Model 3203 S ICD Telemetry wand as an additional antenna LATITUDE Programming System software version not current Contact Boston Scientific using the information on the back cover of this manual Noise problems ECG Improper patient connections Reche...

Page 61: ...hniques between the outlets and from the outlets to other grounded points in the room e g room bonding point cold water pipe exam table etc Telemetry interference Harmful interference caused by the LATITUDE Programming System or the system is negatively impacted by other RF devices Reorient or relocate the devices Increase the separation distance between the devices Connect the equipment to an out...

Page 62: ...ry Unable to print to a USB attached printer Not connected properly Check the USB cable connections between the printer and the Programmer No power Check the printer s power connection Printer not recognized Re connect the printer to the USB port then wait 30 seconds for the system to recognize the printer before sending files to the printer Touchscreen does not respond or goes blank Selecting ina...

Page 63: ...n the back cover of this manual External monitor not displaying properly Cable adapter connection to DisplayPort Remove and re insert cable adapter into DisplayPort to re synchronize the video signal HANDLING The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A Using an External ECG Monitor with the Model 3300 Programmer Use th...

Page 64: ...n an external ECG monitor and the Programmer set up equipment as shown in Figure 32 External ECG Monitor Configuration on page 58 In the example in Figure 32 External ECG Monitor Configuration on page 58 the surface ECG signal travels the following route 1 Model 3153 Fixed Patient Leads ECG cable 2 External ECG monitor 3 Model 6629 ECG BNC slave cable 4 Programmer ECG connector 5 Programmer Model ...

Page 65: ...a Lithium ion battery and as such is deemed a Dangerous Good in regards to shipping Do not return the Model 6753 battery to Boston Scientific Dispose of the battery as required by local regulations If the battery must be shipped contact your local shipper for instructions and shipping requirements Symbols on Devices and Packaging The following symbols may be present on LATITUDE Programming System ...

Page 66: ...eling com Alternating current The power button on the left side of the Programmer which is represented by the Standby symbol USB 2 0 USB 3 0 DisplayPort Local Area Network LAN Port Model 3203 S ICD Telemetry Wand Model 6395 Telemetry Wand PSA LV PSA RA RV Defibrillation proof type CF applied part Defibrillation proof type BF applied part ECG cable connector ...

Page 67: ...ical charge is present ISO 7010 W001 general warning symbol for ECG connector on the Programmer Indicates the risk of electric shock do not touch contacts inside battery compartment refer servicing to Boston Scientific Waste Electrical and Electronic Equipment WEEE indicates separate collection for electrical and electronic equipment i e do not throw this device in the trash This side up Fragile h...

Page 68: ... of the following standards IEC 60601 1 2005 A1 2012 IEC 80001 1 2010 ANSI AAMI ES60601 1 2005 R 2012 EN 60601 1 2006 A1 2013 CAN CSA C22 No 60601 1 2014 EN 62479 2010 EN 62311 2008 Electromagnetic Compatibility Standards The LATITUDE Programming System has been tested and found to comply with the applicable portions of the FCC and IEC electromagnetic compatibility EMC standards FCC Part 15 209 20...

Page 69: ...ications on page 71 Electromagnetic Emissions and Immunity IEC 60601 1 2 2014 Information This equipment has been tested and found to comply with the applicable limits for Class A medical devices in a professional healthcare facility environment to ANSI AAMI IEC 60601 1 2 2014 or BS EN 60601 1 2 2015 or Active Implantable Medical Device Directive 90 385 EEC This testing shows the device provides r...

Page 70: ... 64 Table 5 Guidance and Manufacturer s Declaration Electromagnetic Compatibility The LATITUDE Programming System Model 3300 is suitable for use in professional health care facility environments The customer or the user of this system should assure that it is used in such an environment Test Compliance Electromagnetic environment guidance Protection of radio services and other equipment CISPR 11 G...

Page 71: ... bursts 2 kV input AC power 1 kV SIP SOP Surges line to line 0 5 kV 1 kV input AC power Surges line to ground 0 5 kV 1 kV 2 kV input AC power Conducted disturbances induced by RF fields 3 V m from 0 15 MHz to 80 MHz 6 V m in ISM bands from 0 15 MHz to 80 MHz The ISM bands between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz 40 66 MHz to 40 70 MHz...

Page 72: ...ction with the security practices of hospitals and clinics to provide safe and secure operation of the Programmer and protect the attached network NOTE All patient data is encrypted on the Programmer internal hard drive and the Programmer has network security safeguards in place to prevent malicious attacks Software All installed software has been approved by Boston Scientific and general purpose ...

Page 73: ...y a security threat turn off the Programmer disconnect it from the network then restart the LATITUDE Programming System Discontinue use of the Programmer if it fails the start up self test or does not operate as expected For further assistance contact Boston Scientific using the information on the back cover of this manual SPECIFICATIONS Table 6 LATITUDE Programming System Nominal Specifications C...

Page 74: ...Operating temperature 10 C to 32 C 50 F to 90 F Transport and storage temperature 20 C to 60 C 4 F to 140 F Operating humidity 25 to 85 non condensing Transport and storage humidity 25 to 85 non condensing Operating altitude 3 000 m 9 843 ft Transport and storage atmospheric pressure 50 kPa to 106 kPa 7 252 psi to 15 374 psi External support pen drives printer 3 USB 2 0 ports 1 USB 3 0 port Extern...

Page 75: ...ge resolution ON 0 5 Hz to 40 Hz 10 or 0 1 Hz whichever is greater OFF 0 05 Hz to 100 Hz 20 or 0 02 Hz whichever is greater Gain settings 0 5 1 2 5 10 20 mm mV 25 Electrical Safety Testing Reference for testing according to the IEC 62353 Installation Maintenance Repair a b Earthbond testing Groundbond testing 300 mΩ including power cable not exceeding 3 meters Equipment leakage direct method acces...

Page 76: ...ry ISM Frequency band Bandwidth Modulation Radiated power 916 5 MHz Industrial Scientific and Medical radio band ISM 650 kHz ASK 0 75 mW E I R P Model 6395 Wand Telemetry Inductive Frequency band Bandwidth Modulation Radiated power Receiver category Transmit 20 kHz Receive 0 100 kHZ 125 kHz OOK QPSK 13 7 dBµV m 3 m 3 Bluetooth Frequency band Bandwidth Modulation Radiated power Receiver category 24...

Page 77: ...1ac specifications to connect to networks that are public unsecured WPA PSK or WPA2 PSK Ethernet MAC address The network MAC address can be displayed and the host name is editable Internet protocol IPv4 Dynamic Host Configuration Protocol DHCP mode Both manual and automatic DHCP modes are supported Wi Fi MAC address Displayable WARRANTY INFORMATION A warranty card is packaged with the LATITUDE Pro...

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Page 80: ... North St Paul MN 55112 5798 USA www bostonscientific com 1 800 CARDIAC 227 3422 1 651 582 4000 2017 Boston Scientific Corporation or its affiliates All rights reserved 359487 002 EN US 2017 10 FCC ID ESCCRM330017 Contains FCC ID PD97265NG 359487 002 ...

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