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IC: XXXX-XXX TBD

Industry Canada certification

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Medical Device

Содержание MER3700

Страница 1: ...Merlin 2 Patient Care System Merlin 2 PCS Model MER3700 User s Manual...

Страница 2: ...es a third party trademark which is property of its respective owner Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG Inc 2021 Abbott All Rights Reserved St Jude Medical is a wh...

Страница 3: ...ware Connection 14 Shut Down 14 Emergency Operation 15 External Device Connection 15 Maintenance and Troubleshooting 17 Maintenance 17 Cleaning or Disinfecting 17 Programmer Self Test Preventive Maint...

Страница 4: ......

Страница 5: ...PCS Programmer Software Model MER3400 is a portable dedicated programming system designed to interrogate program display data from and test St Jude Medical implantable medical devices during implant...

Страница 6: ...ical Support Abbott Medical maintains 24 hour phone lines for technical questions and support 1 818 362 6822 1 800 722 3774 toll free within North America 46 8 474 4147 Sweden 61 2 9936 1200 Australia...

Страница 7: ...ion to any USB compatible accessory supported by the system Top port is Port 1 bottom port is Port 2 4 VVI Button Select this button to reprogram a device to high output Emergency VVI settings See Eme...

Страница 8: ...ted to the ECG input port See Merlin 2 PCS Setup page 7 2 Inductive Telemetry Wand connected to the telemetry wand inductive port See Merlin 2 PCS Setup page 7 3 Merlin Antenna connected to the RF tel...

Страница 9: ...rlin 2 PCS Setup page 7 8 Function button For use by Abbott Medical personnel only 9 HDMI port For connection to an external video monitor See External Device Connection page 15 10 Display port connec...

Страница 10: ......

Страница 11: ...ogrammer and accessories on a clean stable and well lit surface Do not place any implantable devices on the inside surface of the programmer when the lid is in the open position and you are attempting...

Страница 12: ...gnostic device NOTE With the 3 lead ECG cable only the Lead I vector is displayed on the Merlin 2 PCS programmer screen 4 Attach the ECG leads to the appropriate electrodes Figure 5 Color codes and po...

Страница 13: ...3 Interrogate monitors button 4 Tools menu Setup for Inductive Telemetry Devices 1 Place the inductive telemetry wand over the patient s device NOTE For devices that use inductive telemetry use only t...

Страница 14: ...rlin PSA Model EX3100 1 Functional Status LEDs 2 Pace and Sense LEDs 3 Receptacle for patient cable or patient cable adapter 4 Connector to Merlin 2 PCS RF Communication Setup Some St Jude Medical imp...

Страница 15: ...and the Merlin 2 PCS 1 Merlin Antenna 2 Merlin 2 PCS 2 Place the Merlin Antenna on a flat surface approximately 1 2 m 2 6 ft from the implanted device The front panel should face the device 3 Follow s...

Страница 16: ...the Merlin 2 PCS displays the FastPath Summary Screen The Active RF Telemetry connection icon appears under the Tools menu button See RF Telemetry Icons page 13 The telemetry strength indicators on t...

Страница 17: ...implanted device that supports Bluetooth Low Energy wireless communication without the need for a dongle Do not put anything between the Merlin 2 PCS and the implanted device People and objects may i...

Страница 18: ...e back of the programmer Figure 10 Network hardware connection Shut Down To power down the Merlin 2 PCS 1 Remove any cables connecting the Merlin 2 PCS to the patient 2 Move the On Off switch to the O...

Страница 19: ...ing the device CAUTION Additional non medical electrical equipment connected to medical electrical equipment which includes equipment connected to the input or output ports must comply with the respec...

Страница 20: ...input for example over the Internet For a list of compatible mice contact your Abbott Medical representative or Technical Support page 2 ECG Input Cable The ECG Input Cable supplied by your Abbott Med...

Страница 21: ...ion directly onto the touchscreen and do not allow the cleaning solution to puddle at the edges of the touchscreen WARNING Keep liquid out of the system s interior and never spray liquid directly onto...

Страница 22: ...se blows again contact the Abbott Medical Technical Support department page 2 System Errors If a software problem occurs the Merlin 2 PCS displays a message indicating that a system error has occurred...

Страница 23: ...erlin Antenna orientation or location is suboptimal People or objects are interfering with the communication between the Merlin Antenna and the device The Merlin Antenna is too far away from the devic...

Страница 24: ...jects or people Move the Merlin 2 PCS closer to the device Power off or remove equipment nearby that could cause EMI If none of the above solutions solve the problem avoid using BLE communication and...

Страница 25: ...ed Power supply Medical grade shielded AC power cord 3 m 10 ft Current consumption 0 5 0 25 A Fuse 5x20 mm slow acting 2 5 A 250 V low breaking capacity cartridge fuse Screen Display LED Color 16 bit...

Страница 26: ...als so that they may assess patient conditions and the functioning of the implantable device As per the risk analysis there have been no unacceptable risks identified in evaluating the clinical functi...

Страница 27: ...ices should be within 2 5 meters in normal use The programmer uses BLE with authentication methods to ensure that the programmer communicates only with St Jude Medical authorized products The integrit...

Страница 28: ...RF Emission CISPR 11 Group 1 The Merlin 2 PCS and the Merlin Antenna use RF energy only for its internal function Therefore the RF emissions are very low and are not likely to cause any interference i...

Страница 29: ...1000 4 11 5 UT 6 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 70 UT 30 dip in UT for 25 c...

Страница 30: ...o 2 7 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 fr...

Страница 31: ...cations equipment For transmitters rated at a maximum output power not listed in the table below the recommended separation distance d in meters can be estimated using the equation applicable to the f...

Страница 32: ...uding interference that may cause undesired operation This transmitter shall be used only in accordance with the FCC Rules governing the Medical Implant Communications Service Analog and digital voice...

Страница 33: ...and Handling Conditions Table 7 Transportation and handling conditions Minimum Temperature C F 25 13 Maximum Temperature C F 70 158 Minimum Humidity non condensing 10 Maximum Humidity non condensing 9...

Страница 34: ...surface ECG signals for real time viewing on the Merlin 2 PCS Merlin Antenna 3638 Yes Provides wireless radio frequency communication between the programmer and the device during a programmer session...

Страница 35: ...d 200 kHz with an H field strength of less than 25 dB A m at 10 m Affixed to this device in accordance with European Council Directives 2002 96 EC These directives call for separate collection and dis...

Страница 36: ...nd New Zealand Radio Spectrum Management RSM Regulatory Compliance Mark RCM This equipment is certified for type certification pursuant of Article 38 24 of the Japan Radio Law Korea Certification mark...

Страница 37: ...33 Symbol Description IC XXXX XXX TBD Industry Canada certification USB port Product literature Manufacturing facility Importer Wi Fi port Medical Device...

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Страница 40: ...nter BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 St Jude Medical Puerto Rico LLC Lot A Interior 2 Rd Km 67 5 Santana Industrial Park Arecibo PR 00612 USA St...

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