St. Jude Medical Merlin 3638, User Manual

Page 1: ...Merlin Patient Care System Merlin PCS Model 3650 Merlin Antenna Model 3638 Merlin PSA Model EX3100 User s Manual ...

Page 2: ...ark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical LLC and its related companies Pat http patents sjm com 2018 St Jude Medical LLC All Rights Reserved ...

Page 3: ...tup 17 Network Hardware Connection 18 Emergency Operation 22 External Device Connection 23 Printer Paper 24 Maintenance and Troubleshooting 25 Maintenance 25 Programmer Self Test Preventive Maintenance 25 Troubleshooting 25 Technical Data 29 Merlin PCS Specifications 29 Merlin Antenna Specifications 30 Essential Performance 30 Electromagnetic Compatibility 30 Storage and Operating Conditions 36 Di...

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Page 5: ...he Merlin PCS and St Jude Medical implantable devices with RF communication capability This manual describes the components setup maintenance and technical data of the Merlin Antenna together with Merlin PCS The Merlin PSA Model EX3100 and the PSA Wand Model 3150 are pacing system analyzers designed for use with the Merlin PCS to evaluate St Jude Medical implantable devices and leads More informat...

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Page 7: ...3 Features Figure 1 Merlin Patient Care System ...

Page 8: ...ontinuous printing of markers and ECG and EGM waveforms 7 Paper Tray Door See Printer Paper page 24 8 Display Latch 9 Shock Button Select this button to display the Shock screen See Emergency Operation page 22 10 VVI Button Select this button to reprogram a device to high output Emergency VVI settings See Emergency Operation page 22 11 Merlin Antenna See RF Communication Setup page 14 12 Inductive...

Page 9: ...ernal Device Connection page 23 RF Communication Setup page 14 and Bluetooth Wireless Communication Setup page 17 Figure 4 Storage compartment connectors with Merlin PSA not installed 3 1 Telemetry wand inductive port For inductive telemetry devices See Merlin PCS Setup page 7 2 RF telemetry port For connection to the Merlin Antenna See RF Communication Setup page 14 3 ECG In port See Merlin PCS S...

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Page 11: ...spital grade cable Figure 5 The power receptacle the fuse holder and the On Off switch 1 Power receptacle 2 Fuse holder 3 On Off switch 3 You can attach a 5 lead or 3 lead ECG to the Merlin PCS With the 5 lead ECG cable attach up to five ECG electrodes to the patient Right Arm Left Arm Right Leg and Left Leg For the fifth or chest electrode choose one C location With the 3 lead ECG cable attach el...

Page 12: ...not allow conductive parts of electrodes or connectors to come into contact with other conductive parts including Earth ground 5 Turn on the power 6 Open the screen display 7 On the Merlin PCS screen select the Adjust Display button to configure the ECG waveform For more information select the button at the top of the screen when the Adjust Display window appears ...

Page 13: ...ver use of more than one wand extension cord may degrade the telemetry signals and range Do not place the inductive wand on top of the Merlin PSA Model EX3100 9 Select the Interrogate button for pacemakers ICDs and CRTs or select the Interrogate Monitors button for cardiac monitors Use the telemetry strength indicators above the screen and on the telemetry wand to position the wand over the device...

Page 14: ...r patient cable adapters the ECG input and the inductive telemetry wand The items previously stored in the compartment can be stored in the Merlin PCS storage pouch see Accessories page 37 When the Merlin PSA is placed in the Merlin PCS the Merlin Antenna can no longer be connected through the storage compartment Instead the Merlin Antenna can be connected to the USB port on the side of the Merlin...

Page 15: ...G input 6 Connectors to Merlin PCS To place the Merlin PSA into the storage compartment follow the steps below To remove the Merlin PSA from storage compartment reverse the steps 1 Turn off the Merlin PCS 2 Remove the Merlin PCS storage compartment door by raising it at a 90 degree angle 3 Grip the lid so you can pull on one side and push on the other side 4 Loosen the lid from the hinge on one si...

Page 16: ...e blue telemetry wand port in the storage compartment 9 Locate the black ECG cable on the back of the Merlin PSA and connect it to the black ECG port in the storage compartment 10 Orient the Merlin PSA over the storage compartment so its ports and LEDs are facing up and the ports are facing away from the Merlin PCS screen Gently lower the Merlin PSA into the storage compartment 11 Facing the back ...

Page 17: ...is powered and operational If it is not on the PSA has not been placed correctly or the Merlin PSA is not functioning properly 16 Select Tools PSA You are now ready to begin a PSA session Consult the Merlin PSA on screen help for instructions on the Merlin PSA operation and maintenance backup battery replacement and connections between the PSA the patient cables and the implanted leads NOTE The Me...

Page 18: ...ne pacing system analyzer at a time If both the Merlin PSA Model EX3100 and the PSA Wand Model 3150 are connected to the Merlin PCS the Merlin will only operate the Merlin PSA and the PSA Wand will not function CAUTION Do not plug the PSA Wand directly into the PSA port on the right side of the Merlin PCS without first connecting it to the PSA Wand adapter Model 3615 Do not plug the PSA Wand into ...

Page 19: ...nnector on the adapter NOTE Connect the Merlin Antenna only to the USB ports on the left side of the programmer Do not connect the Merlin Antenna to the USB port in the flash drive compartment Figure 12 Connection between the Merlin Antenna and the Merlin PCS using the Model EX3190 cable adapter 1 Merlin Antenna 2 Merlin PCS 3 Model EX3190 cable adapter 4 Place the Merlin Antenna on a flat surface...

Page 20: ...e 16 10 The telemetry strength indicators on the Merlin Antenna and the Merlin PCS indicate RF telemetry communication between the Merlin Antenna and the device A single lighted LED indicates telemetry is established A greater number of lighted LEDs indicates greater signal strength If necessary relocate the Merlin Antenna for better communication See Suboptimal RF Communication page 27 11 Once RF...

Page 21: ...vice To establish Bluetooth Low Energy wireless communication follow the instructions below 1 Turn on the Merlin PCS 2 Insert the USB dongle in one of the available USB ports either on the side of the programmer or in the Flash Drive compartment NOTE It is recommended that the USB dongle be left in place for repeated ease of use If the USB dongle is inserted into a side USB port the port compartme...

Page 22: ...the Ethernet card Model EX3211 You have two options to establish wireless connections to the Merlin Patient Care System PCS Wi Fi7 Card Model EX3213 page 20 Wi Fi USB Model EX3212 page 20 Wired Network Hardware Connection To connect the Ethernet card Model 32111 1 Make sure the programmer is turned Off 2 User pliers to remove the Ethernet port cover on the side of the programmer Lay the Ethernet p...

Page 23: ...thernet port on a router For more information about the network configuration for your clinic contact your IT department Figure 15 Ethernet connection using a router port on the wall Figure 16 Ethernet connection using a router NOTE Only use the supplied St Jude Medical Ethernet card EX3211 ...

Page 24: ...o the Wi Fi port Align the Wi Fi card with the bottom of the Wi Fi port Ensure the Wi Fi card fits snugly in the Wi Fi port Figure 17 Insert the Wi Fi card NOTE Only use the supplied St Jude Medical Wi Fi card EX3213 Wi Fi USB Wireless Network Hardware Connection To connect the Wi Fi9 USB EX3212 1 Make sure the programmer is turned Off 2 Open the USB port cover on the programmer 8 Wi Fi is a trade...

Page 25: ...21 Figure 18 Open the USB port cover 3 Insert the Wi Fi USB into the USB port Figure 19 Insert the Wi Fi USB ...

Page 26: ...o red emergency option buttons SHOCK Select this button to display the Shock screen for ICDs From this screen you can deliver therapy 10 VVI Select this button to automatically reset the device to predefined high output settings 11 10 Emergency Shock is not available during Merlin PSA session 11 Emergency VVI settings for each device are defined in the device s User s Manual ...

Page 27: ...ices These devices can be connected to any of the three USB ports on the Merlin PCS The devices can be used to save session records screen captures and database records for patient tracking software to other media The media include Flash drive See Accessories page 37 for Flash drive requirements Floppy drive This device must be powered through the USB port and cannot use an external power supply P...

Page 28: ...down menu select the Preferences button then select the Printer tab 5 Under Selected Printer select the External button 6 Close the window and begin the device session Printer Paper The paper tray on the top of the Merlin PCS holds 200 sheets of fan fold thermal paper 21 x 14 cm 8 25 x 5 5 in 13 It is not necessary to advance the paper once it is loaded The printer autofeeds the paper after a two ...

Page 29: ... a message explaining the cause of the failure Should the self test fail turn off the programmer wait 30 seconds and then restart the programmer If the self test fails again contact Technical Support page 1 The programmer and its electronic accessories have been designed with digital circuitry and does not require calibration Telemetry Wand Sterilization To sterilize the telemetry wand and or cabl...

Page 30: ...al telemetry operation for example parameter programming check the parameter settings and reprogram the device to ensure that the settings are at the desired values Lock Up If the screen freezes during normal operation or if the screen blacks out a lockup may have occurred Possible Causes Lockup may be caused by a variety of software execution problems voltage transients or input errors Solutions ...

Page 31: ...ghtly Make sure that the space between the Merlin Antenna and the device is free from interfering objects people Move the Merlin Antenna closer to the device Make sure that the front of the Merlin Antenna faces the implantable device Power off or remove equipment that could cause EMI Make sure the Merlin Antenna cable is not wound around the Merlin Antenna Do not hold the Merlin Antenna If none of...

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Page 33: ...nsistor LCD with backlight Color 16 bit color Screen type Touch screen Screen size 38 1 cm 15 in diagonal Resolution VGA 1024 x 768 pixels Printer Printing method Thermal Thermal paper 21 x 14 cm 8 25 x 5 5 in fanfold 200 sheets Printing speed 50 mm s 1 97 in s maximum speed ECG Cables 5 lead cable 4 14 m 13 6 ft Model 3626 3 lead cable 4 14 m 13 6 ft Model EX3001 ECG input cable 7 62 m 25 0 ft Te...

Page 34: ...medical professionals so they may assess patient conditions and enable and assess the functioning of the implanted device NOTE For single fault conditions see Troubleshooting page 25 Electromagnetic Compatibility The Merlin PCS and the Merlin Antenna require special precautions with regard to electromagnetic compatibility EMC and should be used in accordance with the information provided in this m...

Page 35: ...hat supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A The Merlin PCS and the Merlin Antenna are 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 Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Table 4 Guidance an...

Page 36: ... typical commercial or hospital environment If the user of the Merlin PCS requires continued operation during power mains interruptions it is recommended that the Merlin PCS be powered from an uninterruptible power supply or a battery Table 5 Guidance and manufacturer s declaration electromagnetic immunity conducted RF and radiated RF Test IEC 60601 Test Level20 Immunity Compliance Level Electroma...

Page 37: ...ymbol Electromagnetic site survey 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 measure...

Page 38: ...r Table 6 Recommended separation distances between portable and mobile communications equipment and the Merlin PCS Rated maximum output power of transmitter W Recommended separation distance according to frequency of transmitter m 24 150 kHz to 80 MHz 80 MHz to 800 MHz25 800 MHz to 2 7 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 0 1 2 1 2 2 3 10 0 3 8 3 8 7 3 100 0 12 12 23 RF Operating Frequenci...

Page 39: ... 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 Operation of the Merlin Antenna requires that it is subject to the following two conditions 1 this device may not cause harmful interference and 2 this de...

Page 40: ...e transmitter automatically monitors and recovers from most communication errors including data integrity errors and excessive latency If wireless Quality of Service QoS is inadequate the programmer automatically switches to inductive telemetry Bluetooth 27 Low Energy wireless communication operates 2 402 to 2 4835 Ghz at 1 megabits s or lower Over a short range within 2 meters in normal use Wirel...

Page 41: ...f hazardous waste from electrical and electronic equipment Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger eco system Accessories Table 8 Clinical Accessories Accessory Model Number Ordered Separately Intended Use 5 lead ECG Cable 3626 Yes Provide surface ECG signals for real t...

Page 42: ...16 Yes Cable extension for the Telemetry Wand to connect to the programmer Bluetooth 30 Low Energy USB dongle BLU1000 Yes Provides connectivity with SJM implantable devices using Bluetooth Low Energy wireless communication This accessory should be used only with the Merlin programmer To avoid risk of exposure to malware do not insert the USB dongle into any other device such as a computer Table 9 ...

Page 43: ... according to the relevant provisions of AIMD directive 90 385 EEC and RE directive 2014 53 EU Annex II Hereby St Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives The full text of the European Union RE directive 2014 53 EU declaration of conformity is available at the following internet address www sjmglobal com eucon...

Page 44: ...he contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem Return the device to St Jude Medical at the end of its operating life Alternating current Type BF applied part Defibrillation proof Display Out port ECG Cable ECG IN cable port Ethernet port Flash drive Fuse Interference may occur in the vicinity of this equipment Merlin Patient Care Syste...

Page 45: ...ue Consult instructions for use Follow instructions for use on this website RF Telemetry port Telemetry wand Telemetry wand port Connect to the RF Telemetry port on the Merlin PCS TÜV Listed US and Canada Conforms to UL60601 1 Certified to CAN CSA C22 2 No 601 1 M90 Symbol is colored blue Temperature limitations Humidity limitation ...

Page 46: ...um 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 for electrical devices FCC Identification Number Industry Canada certification USB port Product literature Caution Magnetic Resonance MR unsafe Do not bring into MRI scan room Wi Fi port Australian Sponsor Authorized EC Repres...

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Page 50: ...n 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 St Jude Medical Australia Pty Limited 17 Orion Road Lane Cove NSW 2066 Australia St Jude Medical Puerto Rico LLC Lot A Interior 2 Rd Km 67 5 Santana Industrial Park Arecibo PR 00612 USA St Jude Medical Operations M Sdn Bhd Plot 102 Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone 11900 Penang Malaysia sjm com 2018 06 ARTEN100166845 A ...