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1. MOVE TOKEN TO PATIENT TRANSCEIVER indicator will go off 7 Within a few seconds the Transceivers STATUS indicators will display FLASHING GREEN if communicating or SOLID YELLOW if communication failed If communication fails repeat steps 1 thru 5 Patient Transceiver ae STATUS TRANSMITTING ECG BEDSIDE indicator A TRANSMITTING ECG will flash GREEN Communication in process with a Monitor Transceiver BEDSIDE CART Monitor Transceiver STATUS RECEIVING ECG indicator will flash ATA GREEN Communication in process with Patient Transceiver eae einen Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 26 LifeSync Wireless System Operation The patient s ECG signal will appear on the 12 lead ECG monitor within a few seconds If ECG cardiac monitor is respiration capable the respiration signal will also appear Cart ECG Cart mode allows a single Patient Transceiver to communicate with two Monitor Transceivers simultaneously to monitor 5 lead or 12 lead ECG signal NOTE This procedure requires a secondary LifeSync Monitor Transceiver configured in Cart mode to be set up on a second ECG device Confirm LifeSync Monitor Transceiver Settings NOTE Make sure a LifeSync BLUE Token is installed in the token port of both Monitor Transceivers Do not change any settings on the BEDSIDE Monitor Transceiver The BEDSIDE Monitor Transceiver is the unit that is already synchro
2. 2 Attach electrodes to all snaps on 5 Lead LeadWear Disposable and place on the patient as indicated in the diagrams and tables below NOTE Follow electrode manufacturer s guidelines for skin prep prior to placing electrodes on patient NOTE Place electrode LA on the left shoulder first See chart for remaining electrode placements 5 Lead LeadWear Disposable Electrode Placement Left shoulder Right shoulder LL Red Left side of chest below navel Left side of chest just above LL V Brown Fourth intercostal space at right sternal border V1 position NOTE Place electrode V2 first See chart for remaining electrode placements Precordial LeadWear Disposable Electrode Placement V2 Fourth intercostal space at left sternal border V3 Midway between V2 and V4 v2 y3 Fifth intercostal space midclavicular line y5 V5 At horizontal level of V4 left anterior axillary line At horizontal level of V4 left midaxillary line Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 36 LifeSync Wireless System Operation NOTE Although the V1 lead on the Precordial LeadWear Disposable is not used for 12 lead operation it should be fastened to the patient s chest in order to avoid accidental pulling of the LeadWear Disposable NOTE The position of the RL Right Leg electrode with the LeadWear Disposable is different from standard ECG lead placement NOTE Conf
3. e Separate lead wires from AC power source e Check ECG monitor or telemetry box e Replace Patient Cable or Cable Adapter If problem cannot be resolved contact LifeSync Corporation Customer Service toll free at 866 ECG 3888 866 324 3888 or email us at CustomerService LifeSyncCorp com Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 58 Technical Specifications Technical Specifications Specifications The LifeSync System meets all applicable requirements for Cardiac Monitors Heart Rate Meters and Alarms as well as applicable requirements for Diagnostic Electrocardiographs per ANSI AAMI EC13 2002 and ANSI AAMI EC11 1991 respectively Specification 5 LEAD MODE 12 LEAD MODE continuous diagnostic ECG monitoring Number of Channels single ended wtRL J4 __ J9 _ _ o up to 500 nA for RL V Frequency Response Method A per EC11 1991 DC 40 Hz 0 0 0 25 dB 40 150 Hz 0 0 1dB Triangle Response Method D per EC13 2002 1096 maximum reduction 20 ms vs 200 ms triangle wave System test with HP Page Writer 100 Line Filter 60 Hz Ch Ch Signal noise 30 uV p v maximum per EC13 2002 ECG Signal Gain WRT RL 1 00 0 01 V V Measured at 10 Hz Ch Ch Gain Difference 0 196 maximum DC 150 Hz CM Rejection 1 mV output with 20 Vrms input at 60 Hz tested with Welch Allyn Propaq per EC13 2002 1 Multi channel Crosstalk 0 5 96 maximum Leadoff Leadoff sensing perfo
4. ki k n cad e lA cae kar a ekin eke N e de HE n Qere BIR 66 LifeSync 2 1 System User s Manual 1 Preface Preface Introduction Indications for Use The LifeSync Wireless System is indicated for use when ECG monitoring is needed and a wireless cable free connection is desired between the patient and the ECG monitor The LifeSync Wireless System will also transmit the patient respiration waveform for those ECG systems that include a respiration function Contraindications The use of the LifeSync Wireless System is contraindicated e When ECG monitor output may be used to perform a synchronized cardio version or intracardiac monitoring e When using an internal monitoring device synchronized to an external device i e in electrophysiology e During use of MRI or PET scan equipment e When performing external pacing Intended Use of LifeSync Wireless System The LifeSync Wireless System is intended for use as a radio frequency signal transmitter and receiver of diagnostic electrocardiographic physiological signals which are displayed on the ECG monitors of various manufacturers systems that have been validated for compatibility ECG systems that are not currently wireless in operation will now be able to be used in a wireless fashion by virtue of being connected to the LifeSync System The LifeSync System will also transmit the patient respiration waveform for those ECG systems that include a respiration func
5. Confirm that the GREEN Battery Charge indicator is flashing Let batteries charge for 8 hours before use System Configuration and Functional Check The LifeSync Wireless System is designed for configuration by a Biomed or other trained individual The absence of switches and configuration options allows for simple operation by the healthcare provider without an understanding of the different configuration modes supported The following procedure guides the Biomed through a full system test including functional tests of all possible configurations and verifying all settings are working A Battery Preparation NOTE Batteries are shipped in a partially charged state with a plastic film cover covering the contacts This film must be removed prior to use 1 Remove the plastic film cover from the battery contacts 2 Leave one battery uncharged Charge a second battery to the fully charged state Partially charge a third battery to the point that only one LED is lit on the Monitor Transceiver battery charge indicator B Monitor Transceiver Set Up Power on Test Battery Charger 1 Insert blue Token into Token port on the top of the Bedside Monitor Transceiver 2 Place the uncharged battery in this Monitor Transceiver confirming that the plastic film contact cover has been removed 3 Connect Monitor Transceiver to the Power Supply and plug to AC Power Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User
6. Connect lead wires from the 12 lead ECG machine to the ECG machine Monitor Transceiver matching colors and lead markings 8 Remove Precordial LeadWear Disposable from package and connect electrode snaps on Precordial LeadWear Disposable to Patient Simulator do not connect V1 RED lead 9 Insert Precordial LeadWear connector into GREEN connector port Leave 5 Lead LeadWear Connector in place F Transceiver Synchronizing Cart 12 Lead 1 Remove blue Token from the ECG machine Monitor Transceiver Confirm Insert Token Into Patient Transceiver Status indicator on this Monitor Transceiver glows SOLID YELLOW 2 Insert Token into Token port on the side of Patient Transceiver Wait for Return Token To Monitor Transceiver Status indicator on Patient Transceiver to FLASH YELLOW Confirm that Patient Transceiver produces a single BEEP when the Token is fully seated 3 Remove Token from Patient Transceiver Confirm that Return Token To Monitor Transceiver Status indicator goes OFF 4 Place Token back into Token port of the ECG machine Monitor Transceiver Confirm that the Monitor Transceiver produces a single BEEP and that the Insert Token Into Patient Transceiver Status indicator goes OFF Confirm that Communication Status indicators on all three transceivers flash GREEN both Bedside and Cart on the Patient Transceiver Confirm that the proper ECG signals appear on both ECG equipment displays and that the ECG signals agree wit
7. Housing Material Radio Protocol Class Range Operating Frequency Channels Power output level PT Lx wireless technology Class 2 10 m 2 402 2 480 GHz 79 1MHz channels 8 3 dBm maximum 38 mW MT 2 8 dBm maximum 72 mW Bluetooth Revision V1 1 Safety EN60601 1 IEC60601 2 27 UL 60601 1 NNNM EN Respiration Specifications Sensing Electrodes RA LL in Patient Transceiver Excitation Frequency 32 kHz Patient Risk Current 10 pA max with AAMI ES 1 test load Frequency Response 0 25 2 0 Hz 6 dB Input Output Dynamic Range 8 ohm p v maximum Base Impedance Range 0 2000 ohms Respiration Output Modulated digital potentiometer in series with RA electrode in MT Copyright 2013 LifeSync Corporation LS 216 Rev B 59 LifeSync 2 1 System User s Manual Technical Specifications 60 Specification Minimum Respiration DC coupled 21 2 kOhms impedance before Lead Fail EMC Information for the LifeSync System 2 1 Use of Power Supplies The LifeSync System 2 1 is compliant for EMC with the following power supplies NEN Input Output f D EM l N escription Voltage Voltage C Compliance ote RDKN55 12M 120 VAC 5 5 VDC V1 JeromeLineqr Power 60 Hz yes 750 mA Supply WSC155MC Jerome 120 VAC A 5 5 VDC Industries Medical Power 060 Hz yes 750 mA Supply Use of Batteries Configuration Tested The LifeSync System 2 1 is compliant for EMC with the following battery pack
8. The Precordial LeadWear Disposable may now be removed from the patient or may be left in place for a future use If necessary move the V BROWN lead of the 5 Lead LeadWear Disposable to desired V lead location NOTE Place ECG lead electrode on V BROWN lead before moving on patient Patient Transfer Wireless to Wireless To permanently transfer a patient from one monitor to another monitor NOTE This requires an extra LifeSync Monitor Transceiver ECG device set up Confirm Transceiver Settings NOTE Make sure a LifeSync Token is installed in the token port of both Monitor Transceivers the extra Monitor Transceiver ON This is the transceiver attached to the monitor that the patient is being ence an transferred to and will become the primary cs ma TENA Monitor Monitor Transceiver 2 Confirm the indicator 5 LEAD or 12 LEAD ME is illuminated 3 Confirm the BEDSIDE is illuminated 1 Press Power On Off switch to turn MOVE TOKEN TO PATIENT TRANSCEIVER REMOVE TOKEN INSERT INTO PATIENT TRANSCEIVER AAIE UNT PATIENT TRANSCTTVER BEEPS AND LEO LING RETURN TOKEN TO MONITOR TRANSCEIVER Synchronize LifeSync Transceivers 1 Follow instructions in SETUP section of extra Monitor Transceiver a Remove Token b Insert into Patient Transceiver c Wait until Patient Transceiver beeps and LED blinks d RETURN TOKEN TO MONITOR TRANSCEIVER Copyright 2013 LifeSyn
9. Transceiver and AC outlet verify green A C indicator lit e Ensure battery is fully inserted and latched e Replace battery e Replace power supply e Replace Monitor Transceiver e Ensure battery is fully charged at installation e Replace battery Copyright 2013 LifeSync Corporation LS 216 Rev B SYmptom Monitor Transceiver not charging battery or Monitor Transceiver battery charge indicator not lit V Lead Off for 5 Lead only No ECG or Leads Off No ECG or Leads Off Continued Cause e Power supply not connected to Monitor Transceiver or AC outlet e Battery not fully inserted e Battery contacts covered e Faulty battery e Faulty power supply e Faulty AC outlet e Monitor Transceiver failure e Monitor Transceiver in 12 LEAD ECG mode See No ECG or Leads Off section e Electrode s faulty not properly placed or skin not properly prepped e Poor LeadWear Disposable connection to electrode s e LeadWear connectors not fully inserted or defective curling scratches etc e LeadWear damaged e End cap damaged e Patient Transceiver battery is discharged or defective e Power supply not connected to Monitor Transceiver or AC outlet e Monitor Transceiver is Off e Incorrect 5 Lead or 12 Lead ECG mode selected e Lead wire s damaged or poor connections to Monitor LifeSync 2 1 System User s Manual 53 Maintenance amp Troubleshooting Solution e Connect power supply to
10. 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 7 Preface Notes Anew LifeSync Replacement Battery LS 405 is recommended after one year of use All LifeSync Wireless System components that are applied to the patient are either passive LifeSync LeadWear Disposables or internally powered LifeSync Patient Transceiver All LifeSync LeadWear Disposables Patient Cables and Cable Adapter components that are applied to the patient are passive The LifeSync Monitor Transceiver can be operated as a Class II device per EN 60601 1 or internally powered This device has been tested and certified to comply with emissions portion of EN 60601 1 2 Medical Electrical Equipment Electromagnetic Compatibility Requirements and Tests Although this device is shielded against Electromagnetic Interference EMI it is recommended that electrically radiating devices not be used in close proximity to this device Portable and mobile RF communications equipment can affect the operation of the LifeSync Wireless System Operation of the LifeSync Wireless System below minimum amplitude of patient physiological signal may cause inaccurate results Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual Introduction to the LifeSync Wireless System Introduction to the LifeSync Wireless 2 1 System System Overview The LifeSync Wireless System is d
11. Cat Description Type EMC Compliance Note Configuration Tested Lithi Stacked Equipment WARNING This equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the Transceivers should be observed to verify normal operation in the configuration in which it will be used Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 61 Technical Specifications Guidance and Manufacturer s Declaration Electromagnetic Emissions The LifeSync System 2 1 is intended for use in the electromagnetic environment specified below The customer or the user of the LifeSync System 2 1 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The LifeSync System 2 1 uses RF energy only for its internal RF emissions Group 1 function Therefore its RF emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment The LifeSync System 2 1 is suitable for use in all establishments including domestic establishments and RF emissions Class B those directly connected to the public low voltage power CISPR 11 DN f supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 Copyright 2013 LifeSync Corporation
12. Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 15 Introduction to the LifeSync Wireless System A new fully charged battery will power a LifeSync Patient Transceiver for a maximum of 16 hours and a LifeSync Monitor Transceiver for a maximum of 8 hours At end of life battery capacity will be approximately 8096 of original capacity It is recommended that batteries be discarded after one year of normal use 400 discharge cycles LifeSync Battery Charge Indicator An easy to read gauge on the Monitor Transceiver front panel indicates amount of charge Each LED represents 2596 of battery life A Low Battery Indicator on the front panel of the Patient Transceiver indicates when less than 60 minutes of operation remain Token The LifeSync BLUE Token is used to establish communication or synchronize the LifeSync Patient Transceiver and LifeSync Monitor Transceiver The BLUE Token is not programmed for a particular transceiver it works by transferring address and communication mode information between two transceivers during the synchronizing process NOTE LifeSync Monitor Transceiver will not operate without BLUE Token BLUE Token should remain in Token port of the LifeSync Monitor Transceiver at all times except when it is being used to synchronize a LifeSync Patient Transceiver Configuration Tokens The LifeSync Monitor Transceiver can be switched from 5 Lead to 12 Lead ECG Mode using the GREEN Toke
13. INTO PATIENT TRANSCEIVER Pull Ded s the flexible cap away from the token port on pa MOVETOKEN TO Patient Transceiver and fully insert BLUE emin ak n OR Token into token port 4 WAIT UNTIL PATIENT TRANSCEIVER BEEPS AND LED BLINKS A single audible BEEP is produced when BLUE Token is fully inserted and RETURN TOKEN INTO MONITOR TRANSCEIVER indicator on the Patient Transceiver will glow FLASHING YELLOW AWA RETURN TOKEN TO 6 MONITOR TRANSCEIVER 5 RETURN TOKEN TO MONITOR TRANSCEIVER ea Remove BLUE token from Patient Transceiver and close flexible cap over token is aa port the RETURN TOKEN INTO MONITOR TRANSCEIVER indicator on the Patient Transceiver will go off 6 Fully insert the BLUE Token into the token port on the Monitor Transceiver The Monitor Transceiver will BEEP when the token is properly re inserted and the MOVE TOKEN TO PATIENT TRANSCEIVER indicator will go off 7 Within a few seconds the Transceivers STATUS indicators will display FLASHING GREEN if communicating or SOLID YELLOW if communication failed If communication fails repeat steps 1 thru 5 Patient Transceiver STATUS TRANSMITTING ECG BEDSIDE indicator will flash GREEN Communication in process with kana aanean Monitor Transceiver E CARI STATUS Monitor Transceiver STATUS RECEIVING ECG indicator will flash ATA GREEN Communication in process with Patient Transceiver eae ei
14. LS 216 Rev B LifeSync 2 1 System User s Manual 62 Technical Specifications Guidance and Manufacturer s Declaration Electromagnetic Immunity The LifeSync System 2 1 is intended for use in the electromagnetic environment specified below The customer or the user of the LifeSync System 2 1 should assure that it is used in such an environment i Electromagnetic environment Immunity test IEC 60601 test level Compliance level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 96 UT gt 95 dip in UT for 0 5 cycle 40 96 UT 60 dip in Ut for 5 cycles 70 UT 30 dip in UT for 25 cycles b UT gt 95 96 dip in Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines Not Applicable for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 96 UT 95 96 dip in Ur for 0 5 cycle 40 UT 60 96 dip in Ut for 5 cycles 70 UT 30 96 dip in Ut for 25 cycles b UT gt 95 96 dip in Ur for 5 sec Not Applicable NOTE Ur is the a c mains voltage prior to application
15. Monitor Transceiver and AC outlet verify green A C indicator lit e Ensure battery is fully inserted and latched e Uncover and charge battery e Replace battery e Replace power supply e User another AC outlet e Replace Monitor Transceiver e Switch to 5 LEAD ECG mode e Replace electrode s and ensure proper skin prep and placement e Ensure that LeadWear Disposable is firmly attached to electrode snaps e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e Inspect for damage and replace if needed e Check end cap replace Patient Transceiver if damaged e Charge battery or replace with fully charged battery and ensure it is properly latched e Replace defective battery e Connect power supply to Monitor Transceiver and AC outlet verify green A C indicator lit e Turn Monitor Transceiver On with power on off switch e Ensure proper 5 Lead or 12 Lead ECG mode selected e Check lead wire s are free of damage and firmly connected to Copyright 2013 LifeSync Corporation LS 216 Rev B Symptom Inverted signal on ECG equipment Intermittent ECG Artifact and Noise Intermittent ECG Artifact and Noise Continued Cause Transceiver e Trunk cable damaged or disconnected from lead wires or ECG monitor e Out of range or at edge of range e Transceivers not synchronized e ECG monitor not operating properly e Patient Transceiver failure eMonitor
16. Transceiver failure e Incorrect lead wire connections to Monitor Transceiver e LeadWear leads incorrectly placed e Electrode s faulty not properly placed or skin not properly prepped e Poor LeadWear Disposable connection to electrode s e LeadWear connectors not fully inserted or defective curling scratches etc e LeadWear damaged LifeSync 2 1 System User s Manual 54 Maintenance amp Troubleshooting Solution Monitor Transceiver Replace if damaged e Check trunk cable for damage or disconnection Replace if damaged e System range exceeded move patient back within 30 feet of Monitor Transceiver e Re synchronize e Check ECG monitor e Replace Patient Transceiver e Replace Monitor Transceiver e Check lead wire s are in the correct lead and properly placed on the Monitor Transceiver e Check LeadWear leads are properly placed e Replace electrode s and ensure proper skin prep and placement e Ensure that LeadWear Disposable is firmly attached to electrode snaps e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e Inspect for damage and replace If needed e End cap damaged e Check end cap replace Patient Transceiver if damaged e Battery not fully inserted e Patient Transceiver battery is discharged or defective e Power supply not connected to Monitor Transceiver or AC e Ensure battery is fully in
17. be removed from the Patient Transceiver and stored separately when not in use for more than a few days See more information about battery storage in the Maintenance and Troubleshooting section on page 50 of this Manual CAUTION e Store rechargeable batteries between 10 C and 26 C 50 F and 80 F e Store rechargeable batteries away from direct sunlight in a low humidity location with little temperature variation e Discard rechargeable batteries according to national state and local regulations Respiration If the Monitor Transceiver is being used with a patient monitor that is equipped to display patient respiration via thoracic impedance pneumography the patient monitor will continue to display patient respiration as long as the patient monitor is configured to derive respiration from Lead LL LA or Lead II LL RA Consult ECG equipment manual for more information about proper settings and operation of the respiration function Also refer to the Specifications section on page 58 of this manual for details on LifeSync Wireless System respiration function Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 33 LifeSync Wireless System Operation User Instructions LeadWear Disposable 5 Lead Monitoring 1 Remove LeadWear Disposable from package NOTE Release LeadWear Disposable from the package insert card with care by pressing on the colored side of each snap DO NO
18. o er bs arua nt ean ai w Tan eu ae RE ee 46 bejna e dj n vay E a N a oe a a a a 46 Battery S LO O uie me oe t lee Ke Ki OK R SE teli e ten e AN Snnt Ke e b seen 46 Patient Cables and Cable Adapters Maintenance l El keke 47 Cleaning LifeSync System Components cccccessecccceesecccceesecccceeseceeceueceeseuseceesenseees 48 Cleaning the Transceivers Battery and Power Supply eee 48 Cleaning and Disinfecting Patient Cables and Cable Adapters 48 Cleaning the LeadWear DISDOSdDIGS d essct ombra imei weku y WARA Ku e re bien 49 jI kel el e OO CIS E TTE 50 Technical SDeClllca Ol SA a e etsi e e e e le n e e Leder Occit cud 58 sel se i ez j op SiYa Ya n ND MEN N dd N T dr r KA 58 Use of POWer Supplies k y y y kak jey s ka ANAL NAWA ke A YR eri xr nan AW reu vs 60 The LifeSync System 2 1 is compliant for EMC with the following power supplies 60 USE SOL BST telles utet ek ve KAW di easel sais ta iau w w D MEDI datos CEDE KN rc DES 60 The LifeSync System 2 1 is compliant for EMC with the following battery pack 60 e Stacked E Q DIT TO s my yyi ninay K n tu ate ipd E ote database S t Orestes 60 Bluetooth Class 2 Radio for Communication eese 64 Manufacturers INONMA OM yk kiya r ya a ad yA etr waar des tutela etas do die iom 65 R ordebDlll FlTI3tlO l gt bune a
19. of the test level Copyright 2013 LifeSync Corporation LS 216 Rev B Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the LifeSync System 2 1 requires continued operation during power mains interruptions it is recommended that the Monitor Transceiver be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment LifeSync 2 1 System User s Manual 63 Technical Specifications Guidance and Manufacturer s Declaration Electromagnetic Immunity The LifeSync System 2 1 is intended for use in the electromagnetic environment specified below The customer or the user of the LifeSync System 2 1 should assure that it is used in such an environment f mplian Immunity test IEC 60601 test level Eo l a ud Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the LifeSync System 2 1 including cables than the recommended separation distance calculated f
20. s Manual 43 Maintenance amp Troubleshooting 4 Press Power On Off switch Confirm that all indicators light for approximately one second and an audible BEEP is heard this is a user interface test Confirm that the GREEN Battery Charging indicator is flashing 5 nsert the green configuration Token marked ECG in the Token port on the top of the Monitor Transceiver The Monitor Transceiver will BEEP 4 times and change the ECG mode which will be illuminated on the front panel Confirm that the configuration function is working by performing this operation several times Select ECG 5 Lead mode 6 Insert the yellow configuration Token Marked Bedside Cart into the Token Port on the top of the Monitor Transceiver The Monitor Transceiver will BEEP 4 times and switch between Bedside and Cart Communication Modes Confirm that the configuration function is working by performing this operation several times Select Bedside Communication Mode 7 Connect lead wires from the cardiac monitor to the Monitor Transceiver matching colors and lead markings C Patient Transceiver Set Up Power on Test 1 Insert the fully charged battery into the Patient Transceiver 2 Remove 5 Lead LeadWear Disposable from package Insert 5 Lead LeadWear Connector into connector port matching connector colors and connector keys 3 Confirm that all indicators light for approximately one second and an audible BEEP is heard this is a user interface test Confirm t
21. the Patient Transceiver Confirm that the Communication Status indicator on the ECG machine Monitor Transceiver SOLID YELLOW the Communication Status indicator on the cardiac Monitor Transceiver flashes GREEN and only the Bedside Communication Status indicator on the Patient Transceiver flashes GREEN G Transceivers Confirm Low Battery Charge Indicators on Patient Transceiver 1 Disconnect Monitor Transceivers from both ECG monitors and turn equipment OFF 2 Remove the batteries from all Transceivers Disconnect the Monitor Transceivers from the Power Supply and plug to AC power 3 Place the partially charged battery in the Patient Transceiver Confirm that the Low Battery Charge indicator flashes YELLOW and an audible tone continues to beep Remove the LeadWear connector to turn Patient Transceiver OFF 4 Place the fully charged battery in one Monitor Transceiver Turn the Transceiver ON and confirm that all Low Battery Charge and Battery Charging indicators are OFF Repeat with the other Monitor Transceiver 5 Place the fully charged battery back into the Patient Transceiver 6 Connect both Monitor Transceivers to the Power Supplies and plug to AC power Confirm that the GREEN Battery Charge indicator is flashing Let batteries charge for 8 hours before use Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 46 Maintenance amp Troubleshooting Rechargeable Battery Battery Life I
22. using a cardiac monitor Confirm LifeSync Monitor Transceiver Settings NOTE Make sure a LifeSync BLUE Token is installed in the token port of the Monitor Transceiver 1 Press Power On Off switch to turn Monitor Transceiver ON 2 Confirm the indicator 5 LEAD is illuminated 3 Confirm the BEDSIDE is illuminated MOVE TOKEN TO PATIENT TRANSCEIVER RETURN TOKEN TO MONITOR RAPES ENTE Apply LifeSync LeadWear Disposable 1 Select appropriate size 5 Lead LeadWear Disposable BLUE connector for the patient refer to size chart on page 10 NOTE For placement of LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 5 Lead Monitoring on page 33 of this Manual 2 Insert BLUE 5 Lead LeadWear Connector into BLUE slot on LifeSync Patient Transceiver This will turn the LifeSync Patient Transceiver ON Ensure that connector is seated securely and that tabs lock into place 3 The LifeSync Patient Transceiver may be placed inside Telemetry Pouch Pouch can be placed on or near the patient Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 23 LifeSync Wireless System Operation Synchronize LifeSync Transceivers 1 Follow instructions in SETUP section of Monitor Transceiver 2 REMOVE TOKEN Remove BLUE Token the BN MOVE TOKEN TO PATIENT TRANSCEIVER EL indicator will glow SOLID YELLOW 3 INSERT
23. 13 LifeSync Corporation LS 216 Rev B 3 LifeSync 2 1 System User s Manual 4 Preface snaps electrodes with opaque posts provide a better indication that LeadWear Disposable snaps and electrodes are outside the body To ensure patient safety only LifeSync LeadWear Disposable products should be used with the LifeSync Patient Transceiver The safety of connecting other devices leads or cables to the Patient Transceiver has not been evaluated and may present safety hazards Furthermore substandard performance may result from the use of incompatible components The LifeSync Monitor Transceiver should only be connected to patient monitors as illustrated in the System Set Up section of this manual and only to those monitors that have been validated for compatibility with the LifeSync and meet ANSI AAMI EC13 2002 and ANSI AAMI EC11 1991 Contact LifeSync Corporation for the most current list of validated monitors Only use the approved LifeSync Power Supply Model LS 132 in order to ensure that the Patient Monitor to which the LifeSync Monitor Transceiver is connected continues to comply with risk leakage current and EMI EMC requirements Normal operation of the LifeSync Wireless System should be verified in the configuration in which it will be used before engaging in use with a patient Inspect and test the LifeSync 2 1 Transceivers rechargeable batteries and power supply frequently Do not operate the LifeSync Wireless S
24. ATUS RECEIVING ECG indicator will flash GREEN Communication in process with Patient Transceiver Eg ea The patient s ECG signal will appear on both BESIDE ECG monitor and CART ECG monitor within a few seconds If CART ECG cardiac monitor is respiration capable the respiration signal will also appear NOTE Cart and Bedside communication modes are independent and can be run without the other The Patient Transceiver will communicate with the CART Monitor Transceiver for two minutes After two minutes the Patient Transceiver will automatically end communication with the CART Monitor Transceiver The Transceiver indicators will reflect the change in communication status Patient Transceiver STATUS TRANSMITTING ECG BEDSIDE indicator STATUS will flash GREEN Communication in process with TRANSMITTING ECG BEDSIDE Monitor Transceiver STATUS 9 BEDSIDE CART TRANSMITTING ECG CART will go off all BEDSIDE Monitor Transceiver STATUS RECEIVING ECG indicator will flash GREEN Communication in process with Patient Transceiver CART Monitor Transceiver DIGNE T ee STATUS RECEIVING ECG indicator will flash YELLOW No Communication po B Copyright 2013 LifeSync Corporation LS 216 Rev B 28 LifeSync 2 1 System User s Manual 29 LifeSync Wireless System Operation Cart 12 Lead ECG Only Remove Precordial LeadWear Disposable 1 Disconnect the GREEN Connector from the Patient Transceiver
25. CG monitoring Used in combination with the 5 Lead LeadWear Disposable for 12 lead ECG monitoring Precordial LeadWear GREEN Disposable Connector 5 Lead LeadWear Disposables LS 228 LS 229 rant Sue vied RAIA wu _ls222 9 i 28 lt a Precordial LeadWear Disposables Part Size Description V1 V2 V2 V3 V3 V4 V4 VS v5 v6_ Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 11 Introduction to the LifeSync Wireless System 12 Lead LeadWear Disposables 12 Lead LeadWear Disposables LS 208A LS 228 LS 238A LeadWear Disposables are packaged three ways 5 Lead One 5 Lead LeadWear Disposable One 5 Lead LeadWear Disposable and L lk One Precordial LeadWear Disposable Precordial One Precordial LeadWear Disposable LeadWear connectors are color coded to ensure proper connection to the LifeSync Patient Transceiver BLUE connectors on the 5 Lead LeadWear Disposable and GREEN connectors on the Precordial LeadWear Disposable NOTE LifeSync LeadWear Disposables are non sterile Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 12 Introduction to the LifeSync Wireless System 2 1 Patient Transceiver LifeSync LeadWear Connector Ports Color coded ports for attachment of the LeadWear Disposable Blue for the 3 5 LeadWear Disposable Green for the Precor
26. Corporation LifeSync 2 1 System User s Manual LifeSync Corporation 3350 NW 53 Street Suite 105 Fort Lauderdale Florida 33309 U S A Copyright 2013 LifeSync Corporation All rights reserved No part of this manual may be reproduced photocopied or transmitted without the express written consent of LifeSync Corporation LifeSync and LeadWear are trademarks of LifeSync Corporation www LifeSyncCorp com Table of Contents METTI UL E E EE E N 1 liar lalo Piinia a D Dm 1 Hadicatons Tor S r san TL D Mer ERE 1 Contraindicatii Set DD DD DD Cea de N KN Ka 1 Intended Use of LifeSync WIRE J SO 5 SL O D asdemeec E E du Ne Eck Y ve AN EE 1 Caution Warning CONVENON S xeyl Aerandyna medyay ae ebaya n b n kas y n day A Eek nA YA b d 2 SVM elel SU DD EE E a T DOLUS 3 Sale VIR ONT A ON e ee a Em 3 Lan la DD gvWvo lt oe lt a ra wr w raZ h cge 3 CUON c 6 NOTOS eec pr E iV Ken e 7 Introduction to the LifeSync Wireless 2 1 System cccccccsssecceceesecceeeeeceeeeeeeceeseeeeeeeees 8 SV SECM OV SI Si co e colssinicuactea ttt A cantaes AME RR US On UEM PN Nov DEDERE ORa RUE 8 LIND AGCKING Checks wy yeke kan l nan x n xwi aie AN Nan a eec teams AW AN edd 9 2A dipinti ILE 9 2 1 MOUItOE Trans ce sued inidetdreniel a omnt er ed Kur ek KENAN Cord lob Mode ente ub Ui 9 LeadWear PISO SAIC r r 9 Li
27. One LifeSync Patient Transceiver LifeSync LeadWear Disposable ECG RESP 12 Lead Patient Simulator Two LifeSync System Compatible ECG Monitors One 5 lead Bedside Monitor including trunk cable and lead wires One 12 lead ECG Machine including trunk cable and lead wires NOTE The LifeSync System performance has been confirmed with a variety of commonly used ECG equipment Contact LifeSync Corporation Customer Service at 866 ECG 3888 for information on ECG monitors that are compatible with the LifeSync System A Battery Preparation NOTE Batteries are shipped in a partially charged state with a plastic film cover covering the contacts This film must be removed prior to use 1 Remove the plastic film cover from the battery contacts 2 Leave one battery uncharged Charge a second battery to the fully charged state Partially charge a third battery to the point that only one LED is lit on the Monitor Transceiver battery charge indicator Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 40 Maintenance amp Troubleshooting B Monitor Transceiver Set Up Power on Test Battery Charger 1 Insert blue Token into Token port on the top of the Bedside Monitor Transceiver 2 Place the uncharged battery in this Monitor Transceiver confirming that the plastic film contact cover has been removed 3 Connect Monitor Transceiver to the Power Supply and plug to AC Power 4 Press Po
28. Sync mounting plate and slide transceiver unit downward until it clicks into place 4 Connect leads of the standard ECG lead wire set from the ECG equipment to the corresponding snap attachments on the LifeSync Monitor Transceiver matching lead marking and color codes 5 Ensure a LifeSync BLUE Token is seated in the Token port on Monitor Transceiver NOTE LifeSync Monitor Transceiver will not operate without LifeSync BLUE Token BLUE Token should remain in token port of the Lifesync Monitor Transceiver at all times except when it is being used to synchronize a LifeSync Patient Transceiver Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 20 LifeSync Wireless System Operation Configuration of the LifeSync 2 1 Monitor Transceiver for 5 or 12 Lead Operation 1 Connect LifeSync Monitor Transceiver to LifeSync Power Supply and AC power source 2 Power up Monitor Transceiver by depressing On Off switch 3 Current 5 or 12 ECG mode will be illuminated 4 To change ECG mode configuration remove the synchronization BLUE Bm r ES o Token from the slot on the Monitor Transceiver 2 MER TEE 5 nsert the GREEN Configuration Token into the Token slot 6 The Monitor Transceiver will BEEP 4 e times and illuminate the new ECG mode r 7 Remove the GREEN configuration Token and replace with the BLUE synchronization Token NOTE LifeSync Mo
29. T pull snaps out of holes by tugging on the LeadWear Disposable itself 2 Attach electrodes to all snaps on the LeadWear Disposable and place on the patient as indicated in the diagram and table below NOTE Follow electrode manufacturer s guidelines for skin prep prior to placing electrodes on patient NOTE Place electrode LA on the left shoulder first See chart for remaining electrode placements 5 Lead LeadWear Disposable Electrode Placement Black Left shoulder White Right shoulder LL Red Left side of chest below navel Left side of chest just above LL Center of chest desired location Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 34 LifeSync Wireless System Operation NOTE The position of the RL Right Leg electrode with the LifeSync LeadWear Disposable is different from standard ECG lead placement NOTE Confirm the fit of LeadWear Disposable on patient If lead placements don t reach or there is too much slack select a different size Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 35 LifeSync Wireless System Operation 12 Lead Monitoring 1 Remove LeadWear Disposable from package s NOTE Release LeadWear Disposable from the package insert card with care by pressing on the colored side of each snap DO NOT pull snaps out of holes by tugging on the LeadWear Disposable itself
30. a Battery Charge Indicator that flashes YELLOW when its battery is running low accompanied by a periodic BEEP Replace the low battery with a fully charged battery within 60 minutes to maintain Transceiver operation Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual LifeSync Wireless System Operation WARNING Battery capacity will change over the life of the battery A fully charged unit does not mean that the battery is capable of running the Patient Transceiver If battery is more than one year old it is recommended that the battery be replaced Exchanging Batteries First remove the charged battery from the Monitor Transceivers by releasing the battery latch and sliding the battery out of the battery slot Exchange charged battery from Monitor Transceiver with battery in Patient Transceiver Insert the replacement battery with contacts facing the transceiver body and arrows on the battery facing up when viewing the front of the Transceiver Secure battery latch Insert battery from Patient Transceiver into the Monitor Transceiver for charging NOTE Exchanging batteries does not require re synchronization of Transceivers Charging Batteries When the Monitor Transceiver is connected to the Power Supply and plugged to AC power it functions as a charger for the battery The battery reaches full charge in less than eight hours NOTE At end of life battery capacity will
31. ach LED represents 2596 of battery life 2 Release the battery latch by pushing the latch thumb hold toward the back of the transceiver Remove battery from each transceiver 3 Re install battery into each transceiver and secure by pulling the latch thumb hold toward the front of the transceiver until it snaps securely into place NOTE Use a fully charged battery To charge the LifeSync Rechargeable Battery ensure the LifeSync Monitor Transceiver is connected to the LifeSync Power Supply and plugged to AC power and the battery is fully inserted and latched Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 19 LifeSync Wireless System Operation Mount the LifeSync 2 1 Monitor Transceiver 1 Connect LifeSync Monitor Transceiver to LifeSync Power Supply and AC power source The Monitor Transceiver can be used with a fully charged battery without the Power Supply when installed on a transport monitor or ECG cart 2 Secure the LifeSync Mounting Plate to the desired location using the supplied double sided adhesive tape or other method The LifeSync Mounting Plate is pre drilled for attachment to a variety of third party mounting solutions including the GCX series of pole and rail mounts not supplied by LifeSync NOTE The arrow on the LifeSync Mounting Plate must be pointing upward 3 Insert buttons on back of LifeSync Monitor Transceiver into slots on Life
32. at Return Token To Monitor Transceiver Status indicator goes OFF 4 Place Token back into Token port of the Bedside Monitor Transceiver Confirm that the Monitor Transceiver produces a single BEEP and that the Insert Token Into Patient Transceiver Status indicator goes OFF Confirm that Communication Status indicators on both Transceivers flash GREEN over Bedside on the Patient Transceiver Confirm that the ECG Respiration signals appear on the cardiac monitor display and that the ECG Respiration signals agree with the ECG Patient Simulator settings Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 41 Maintenance amp Troubleshooting E Monitor Transceiver Set Up Cart 12 Lead 1 Insert blue Token into Token port on the top of the ECG machine Monitor Transceiver 2 Placethe third partially charged battery in the ECG machine Monitor Transceiver confirming that the plastic film contact cover has been removed 3 Press Power On Off switch Confirm that all indicators light for approximately one second and an audible BEEP is heard this is a user interface test Confirm that the YELLOW Low Battery Charge indicator is flashing and that an audible tone continues to beep 4 Connect the ECG machine Monitor Transceiver to the Power Supply and plug to AC Power 5 Confirm the ECG Mode indicator shows ECG 12 Lead mode 6 Confirm the Communication Mode indicator shows Cart Communication Mode 7
33. be approximately 8096 of original capacity It is recommended that batteries be discarded after one year of normal use 400 discharge cycles CAUTION Use only a LifeSync Monitor Transceiver to recharge the battery Copyright 2013 LifeSync Corporation LS 216 Rev B 31 LifeSync 2 1 System User s Manual 32 LifeSync Wireless System Operation Monitor Transceiver Battery Charging Indicator The Battery Charging indicator on the front of the Monitor Transceiver displays a GREEN FLASHING light when the battery charger function is active As the battery is charged or discharged the number of LEDs illuminated increases or decreases Each LED represents 2596 of battery capacity When the Monitor Transceiver is not connected to the Power Supply and plugged to AC power and is being powered by a rechargeable battery the battery charger function is inactive and the Battery Charging indicator will not be lit and the gauge will indicate the remaining battery available When the Monitor Transceiver is connected to the Power Supply and plugged to AC power and has a less than fully charged rechargeable battery installed the Battery Charging indicator will flash GREEN to indicate that the battery is charging It will take up to eight hours for the Monitor Transceiver to finish charging a discharged battery The Battery Charging indicator will glow SOLID GREEN for all LEDs when charging is complete Battery Storage The battery should
34. ble Adapters Intermittent Noisy ECG or Respiration Cause e ECG monitor or telemetry box not operating properly e Patient Cable or Cable Adapter Failure housing damage broken wire s socket damage plug damage etc e Electrode s faulty not properly placed or skin not properly prepped e eadWear leads incorrectly placed e Poor LeadWear Disposable connection to electrode s e eadWear connectors not fully inserted or defective curling scratches etc e eadWear damaged e Trunk cable damaged or not properly connected to Cable Adapter or ECG monitor telemetry box e Lead wire s too close to AC power source e ECG monitor or telemetry box not operating properly e Patient Cable or Cable Adapter Failure housing damage broken wire s socket damage plug damage etc LifeSync 2 1 System User s Manual 57 Maintenance amp Troubleshooting Solution e Check ECG monitor or telemetry box e Replace Patient Cable and Cable Adapter e Replace electrode s and ensure proper skin prep and placement e Check LeadWear leads are properly placed alternative placement may interfere with respiration e Ensure that LeadWear Disposable is firmly attached to electrode snaps e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e nspect for damage and replace if damaged e Check trunk cable for damage and proper connection Replace if damaged
35. c Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 30 LifeSync Wireless System Operation NOTE Step by step instructions for 5 LEAD wireless monitoring are found on page 22 Step by step instructions for 12 LEAD wireless monitoring are found on page 24 System Removal 1 Leave the Monitor Transceiver attached to the side of the patient monitor until its next use The Monitor Transceiver can be left on unless it will not be used for an extended period of time To turn the Monitor Transceiver OFF Press Power On Off switch 2 Remove Patient Transceiver Telemetry Pouch To remove LeadWear connectors from Transceiver squeeze clips on LeadWear connector and pull straight out from Transceiver 3 Gently remove LeadWear Disposable and electrodes from patient Discard LeadWear Disposable electrodes and Telemetry Pouch 5 Store Patient Transceiver in a designated storage location P NOTE If system is not to be used for an extended period the batteries should be removed from the Patient Transceiver and the Monitor Transceiver and stored separately LifeSync Rechargeable Batteries The Monitor Transceiver should be connected to the Power Supply and plugged to AC power at all times in order to ensure the battery is fully charged When the battery in the Patient Transceiver runs low it can quickly be exchanged for a fully charged battery in the Monitor Transceiver NOTE Each Transceiver has
36. ce if damaged e Separate lead wires from AC power source e Check trunk cable for damage and proper connection Replace if damaged e System range exceeded move patient back within 30 feet of Monitor Transceiver e Fully insert token on Monitor Transceiver and synchronize if needed e Re synchronize e Advise patient to be still e Check ECG monitor e Replace Patient Transceiver e Replace Monitor Transceiver e Replace electrode s and ensure proper skin prep and placement e Check LeadWear leads are properly placed alternative placement may interfere with respiration e Ensure that LeadWear Disposable is firmly attached to electrode snaps e Remove inspect for damage and replace or reinsert Copyright 2013 LifeSync Corporation LS 216 Rev B Symptom Patient Cables and Cable Adapters No ECG or Respiration Patient Cables and Cable Cause curling scratches etc e LeadWear damaged e End cap damaged e Lead wire s damaged or poor connections to Monitor Transceiver e Lead wire s too close to AC power source e Trunk cable damaged or disconnected from lead wires or ECG monitor e Respiration function not selected on ECG equipment e Patient Transceiver failure e Monitor Transceiver failure e Electrode s faulty not properly placed or skin not properly prepped e LeadWear leads incorrectly placed e Poor LeadWear Disposable connection to electrode s e LeadWear connectors
37. ct V1 RED lead 9 Insert Precordial LeadWear connector into GREEN connector port Leave 5 Lead LeadWear Connector in place F Transceiver Synchronizing Cart 12 Lead 1 Remove blue Token from the ECG machine Monitor Transceiver Confirm Insert Token Into Patient Transceiver Status indicator on this Monitor Transceiver glows SOLID YELLOW 2 Insert Token into Token port on the side of Patient Transceiver Wait for Return Token To Monitor Transceiver Status indicator on Patient Transceiver to FLASH YELLOW Confirm that Patient Transceiver produces a single BEEP when the Token is fully seated 3 Remove Token from Patient Transceiver Confirm that Return Token To Monitor Transceiver Status indicator goes OFF 4 Place Token back into Token port of the ECG machine Monitor Transceiver Confirm that the Monitor Transceiver produces a single BEEP and that the Insert Token Into Patient Transceiver Status indicator goes OFF Confirm that Communication Status indicators on all three transceivers flash GREEN both Bedside and Cart on the Patient Transceiver Confirm that the proper ECG Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 45 Maintenance amp Troubleshooting signals appear on both ECG equipment displays and that the ECG signals agree with the ECG Patient Simulator settings 5 Wait for two minutes After two minutes the ECG machine Monitor Transceiver stops receiving signals from
38. dial LeadWear Disposable LifeSync Token Port Insert the Blue Token here to synchronize the Transceivers Token port is protected by a flexible cap when not in use Battery Latch Holds battery in place LifeSync Battery Battery is removable for charging in the Monitor Transceiver Turn Patient Transceiver ON by inserting a Blue 3 5 Lead LeadWear Connector into the BLUE connector port a a Only use the Blue Token to synchronize Patient Transceiver VISUAL STATUS INDICATORS SETUP RETURN TOKEN TO MONITOR YELLOW FLASHING Return Token to Monitor Transceiver The Transceiver TRANSCEIVER will BEEP once when Token is fully inserted STATUS No Communication YELLOW SOLID GREEN FLASHING Bedside monitor communication in process No Communication TRANSMITTING ECG CART YELLOW SOLID No Communication GREEN FLASHING Cart communication in process F All leads connected LEAD OFF YELLOW SOLID Check patient leads and electrodes Battery has operational charge Low charge level swap battery with Monitor Transceiver LOW BATTERY _ _u YELLOW FLASHING MONITOR TRANSCEIVER 4 SERVICE RED SOLID OR FLASHING Transceiver malfunction service required Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 13 Introduction to the LifeSync Wireless System 2 1 Monitor Transceiver LifeSync Token Port Insert the Tokens he
39. eSync System 2 1 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12 P d 2 3 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 Bluetooth Class 2 Radio for Communication The LifeSync System 2 1 intentionally receives RF electromagnetic energy for patient monitoring and diagnosis using Bluetooth Class 2 radios Although no issues have been observed with coexistence with 802 11 b g equipment the user should be aware that the LifeSync System 2 1 operates in the same frequency band as 802 11 b g The RF band of reception for the LifeSync System 2 is 2 400 GHz to 2 4835 GHz The overall band of the signal is 83 5Mhz with 79 channels of adaptive frequency hopping Each channel has a bandwidth of 1 Mhz The LifeSync Sy
40. esigned to eliminate the ECG lead wires and cables that connect patients to cardiac monitoring equipment The system has several components which work together to carry signals from the patient to the monitor The lead wire function is replaced by the LifeSync LeadWear Disposable Cable Replacement System which attaches directly to electrodes The trunk cable function is replaced by a pair of two way radios the LifeSync 2 1 Patient Transceiver and the LifeSync 2 1 Monitor Transceiver which wirelessly transmit and receive ECG and respiration data LeadWear Disposables connect to the LifeSync Patient Transceiver the LifeSync Monitor Transceiver is connected to the ECG monitor A LifeSync Token is used to synchronize the two transceivers this ensures that the patient s ECG signal is being sent to the correct monitor The LifeSync Patient Transceiver is powered by the LifeSync Rechargeable Battery The LifeSync Monitor Transceiver can also be powered by a LifeSync Rechargeable Battery for portable use but is intended to be operated using LifeSync Power Supply connected to standard AC power when available While connected to AC power the LifeSync Monitor Transceiver functions as a battery charger When the battery in the LifeSync Patient Transceiver runs low it can be quickly exchanged for the fully charged battery in the LifeSync Monitor Transceiver The LifeSync Patient Transceiver may be placed in a single patient u
41. feSync LeadWear DISDOSSDIG uote hti K ela keze ane catre etus osito ets 10 2 1 PatlenE TrarscelVel aestu Seem gu m MR Nm E m Mu KK e R MI M 12 241 MODIEOF iranse Vease Cete iS MR Rt Y pnt SA Eva tq Debo Numi T usato uates Ge ek Ka A W 13 LifeSync Rechargeable Battery LS AH05 keke kek ka 14 TOKE a MA YDA NN KANE Stas RA N EE NE sed A DN N A U a nan 15 Conrigutration TOKENS cesta udo dud ye De i ak a dod tud a K ee S ka A 15 Power SUD DIV LS I3 2 rn l a eth o v Vti pie ud tti nO Waw VR a Pis uri uidi 16 PCCOSSONIES yx 16 Teleme wy POUCH asain n ederent WADAN ec iue a aS R Naaa wa Tan n k ee tat 16 Introduction to LifeSync Patient Cables and Cable Adapters esses 17 Patient Cables and Cable Adapters eene nnne 17 LifeSync Wireless System Operations dec casia sores eara a Verve mega co serere caa xp Mer dee dins 18 Wireless System Seb UD uice A me cnt cot e a is ye ied de ins va Menno ec n b coya Y 18 Install Check Batteries in TranSCce VIrS EE E keke keke k kek K KK Ae 18 Mount the LifeSync 2l MONOC TratscelVel yy ney neo ie uu iua Ree KESAN wandin we Mela r n 19 Configuration of the LifeSync 2 1 Monitor Transceiver for 5 or 12 Lead Operation eS 20 Configuration of the LifeSync 2 1 Monitor Transceiver for Bedside or Cart zena DY TET 21 User Instructions Wireless MONitoring ccccsscccc
42. h the ECG Patient Simulator settings 5 Wait for two minutes After two minutes the Cart ECG machine Monitor Transceiver stops receiving signals from the Patient Transceiver Confirm that the Communication Status indicator on the Cart ECG machine Monitor Transceiver SOLID YELLOW the Communication Status indicator on the cardiac Monitor Transceiver flashes GREEN and only the Bedside Communication Status indicator on the Patient Transceiver flashes GREEN Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 42 Maintenance amp Troubleshooting G Transceivers Confirm Low Battery Charge Indicators on Patient Transceiver 1 Disconnect Monitor Transceivers from ECG equipment and turn equipment OFF 2 Remove the batteries from all Transceivers Disconnect the Monitor Transceivers from the Power Supply and plug to AC power 3 Place the partially charged battery in the Patient Transceiver Confirm that the Low Battery Charge indicator flashes YELLOW and an audible tone continues to beep Remove the LeadWear connector to turn Patient Transceiver OFF 4 Place the fully charged battery in one Monitor Transceiver Turn the Transceiver ON and confirm that all Low Battery Charge and Battery Charging indicators are OFF Repeat with the other Monitor Transceiver 5 Place the fully charged battery back into the Patient Transceiver 6 Connect both Monitor Transceivers to the Power Supplies and plug to AC power
43. hat the Low Battery Charge indicator is OFF 4 Connect electrode snaps on 5 LeadWear Disposable to Patient Simulator D Transceiver Synchronizing Single Bedside 1 Remove blue Token from the Bedside Monitor Transceiver Confirm Insert Token Into Patient Transceiver Status indicator on Monitor Transceiver glows SOLID YELLOW 2 Insert Token into Token port on the side of Patient Transceiver Wait for Return Token To Monitor Transceiver Status indicator on Patient Transceiver to FLASH YELLOW Confirm that Patient Transceiver produces a single BEEP when Token is fully seated 3 Remove Token from Patient Transceiver Confirm that Return Token To Monitor Transceiver Status indicator goes OFF 4 Place Token back into Token port of the Bedside Monitor Transceiver Confirm that the Monitor Transceiver produces a single BEEP and that the Insert Token Into Patient Transceiver Status indicator goes OFF Confirm that Communication Status indicators on both Transceivers flash GREEN over Bedside on the Patient Transceiver Confirm that the ECG Respiration signals appear on the cardiac monitor display and that the ECG Respiration signals agree with the ECG Patient Simulator settings Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 44 Maintenance amp Troubleshooting E Monitor Transceiver Set Up Cart 12 Lead 1 Insert blue Token into Token port on the top of the ECG machine Monitor Transceive
44. he ECG electrodes sites by ensuring proper connection of the electrosurgery return pad so that the return path cannot be made through the Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 5 Preface ECG electrodes Care should be taken to prevent physical contact between electrosurgical equipment and any LifeSync Wireless System component The ECG and respiration signals will be interrupted for no more than a few seconds if the electrosurgical current path is close to the ECG leads To ensure patient safety the conductive parts of ECG electrodes any conductive parts of the LifeSync LeadWear Disposable or any other conductive patient applied parts should not contact any other conductive parts including earth ground at any time LifeSync Wireless System and LifeSync Patient Cables and Cable Adapters should not be used in a Magnetic Resonance Imaging MRI suite Strong magnetic fields may affect the device causing injury to the patient and or damage to the equipment The LifeSync Wireless System and LifeSync Patient Cables and Cable Adapters can operate in the presence of pacemaker pulses and will detect and communicate these pulses to the ECG monitor The LifeSync Wireless System may miss pacer pulses if high background noise is present The LifeSync Wireless System captures signal spikes regardless of whether spikes are due to noise or pacer pulses If the LifeSync Wireless System trigger
45. ic imaging The LifeSync Patient Transceiver and LifeSync Monitor Transceiver have been tested and shown to comply with FCC Part 15 Any changes or modifications to the LifeSync Wireless System not expressly approved by LifeSync Corporation could cause LifeSync Wireless System emissions to exceed those permitted under FCC rules and would thus void the user s authority to operate the equipment When using a 3 lead patient cable to connect the ECG equipment to the LifeSync Monitor Transceiver Welch Allyn Propag and Philips Viridia monitors will not properly detect and display a lead fail indication if one of the three electrodes RA LA LL becomes detached from the patient Note that the monitor will function properly if connected to the LifeSync Monitor Transceiver with a 5 lead cable Only use the LifeSync Wireless System and LifeSync Patient Cables and Cable Adapters with ECG equipment that has been validated for compatibility Contact LifeSync Corporation Customer Service at 866 ECG 3888 for information on ECG Monitors that are compatible with the LifeSync Wireless System Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Note Validation testing for additional ECG equipment is ongoing Please contact LifeSync Corporation at 866 ECG 3888 for the current list of compatible equipment Copyright
46. ing on page 33 of this Manual 2 Connect Patient Cable or Cable Adapter to the trunk cable or monitoring equipment 3 Connect the LeadWear Disposable BLUE connector to the Patient Cable or Cable Adapter Copyright 2013 LifeSync Corporation LS 216 Rev LifeSync 2 1 System User s Manual 38 LifeSync Patient Cables and Cable Adapters Operation Patient Transfer Wireless to Patient Cables and Cable Adapters To permanently transfer a patient from wireless monitoring to a wired connection 1 Connect Patient Cable or Cable Adapter to the trunk cable or monitoring equipment 2 Remove LeadWear Disposable from the LifeSync Patient Transceiver by squeezing clips on LeadWear Connector s and pulling straight out from transceiver 3 Connect LeadWear Disposable BLUE connector 5 Lead or GREEN connector 12 Lead to the Patient Cable or Cable Adapter Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 39 Maintenance amp Troubleshooting Maintenance amp Troubleshooting System Functional Check The LifeSync Wireless System requires neither technical maintenance nor calibration It is recommended that the following procedure be used to confirm the proper function of system components before initial use and at regularly scheduled intervals as dictated by the institution s plan for equipment performance confirmation Required Equipment Two LifeSync Monitor Transceivers
47. irm the fit of LeadWear Disposable on patient If lead placements don t reach or there is too much slack select a different size Copyright 2013 LifeSync Corporation LS 216 Rev B 37 LifeSync 2 1 System User s Manual LifeSync Patient Cables and Cable Adapters Operation LifeSync Patient Cables and Cable Adapters Operation User Instructions Patient Cables and Cable Adapters 12 Lead Patient Cables and Cable Adapters To use LeadWear Disposable directly with 12 Lead ECG monitoring equipment 1 Select appropriate size 5 Lead LeadWear Disposable BLUE connector and precordial LeadWear Disposable GREEN connector for the patient refer to size chart on page 10 NOTE For placement of LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 12 Lead Monitoring on page 35 of this Manual Ensure the monitor is set for 12 Lead monitoring 2 Connect Patient Cable or Cable Adapter to the trunk cable or monitoring equipment 3 Connect the LeadWear Disposables BLUE and GREEN connector to the Patient Cable or Cable Adapter 5 Lead Patient Cables and Cable Adapters To use LeadWear Disposable directly with ECG monitoring equipment 1 Select appropriate size 5 Lead LeadWear Disposable BLUE connector for the patient refer to size chart on page 10 NOTE For placement of LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 5 Lead Monitor
48. ituation where excess force would be applied to the patient resuscitation please have a secondary method of monitor readily available to avoid a period of time where the patient is not monitored Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 6 Preface When disconnecting the LifeSync Patient Cables and Cable Adapters pull on the plug itself not on the cable Cautions The LifeSync Patient Transceiver and LifeSync Monitor Transceiver are Class 2 Bluetooth devices with a range of 10 meters 30 feet Range may be reduced from obstructions such as walls concrete or metal structures Optimal range of communication is achieved by line of sight in which both transceivers see the other without obstructions When possible maintain line of sight to improve range The rechargeable batteries should be removed from both the LifeSync Patient Transceiver and the LifeSync Monitor Transceiver and stored separately when the system is not in use for extended periods of time Remove the plastic film cover from the rechargeable battery contacts before using Do not autoclave LifeSync Wireless System components or LifeSync Patient Cables and Cable Adapters Do not submerge LifeSync Wireless System components or LifeSync Patient Cables and Cable Adapters in any liquid LifeSync LeadWear Disposable is radiolucent Areas of the circuit may show shadows on x ray or under fluoroscop
49. les with ECG monitoring equipment via direct electrical connection Contact your Sales Representative or Customer Service for a current list of Cable Adapters available NOTE LifeSync Patient Cables and Cable Adapters are connected directly to the monitor or trunk cable of 5 or 12 lead ECG monitors as well as directly connected to wireless telemetry transmitters NOTE LifeSync Patient Cables and Cable Adapters are non sterile reusable and latex free Copyright 2013 LifeSync Corporation LS 216 Rev B 17 LifeSync 2 1 System User s Manual 18 LifeSync Wireless System Operation LifeSync Wireless System Operation The LifeSync Wireless System works with existing ECG monitor equipment NOTE Proper function of the LifeSync Wireless System with the ECG monitoring equipment should be confirmed before use with a patient See System Functional Check on page 39 of this Manual Wireless System Set Up Install Check Batteries in Transceivers NOTE If battery is new remember to remove the plastic tape from the battery contacts before first use A new battery will need to be charged in a LifeSync Monitor Transceiver for approximately eight hours before first use 1 Check battery charge level by installing each battery into a Monitor Transceiver connected to A C power If all four battery indicators are not lit allow the battery to fully charge or replace battery with a fully charged battery E
50. n and from Bedside Permanent Monitoring to Cart Temporary Monitoring using the YELLOW Token NOTE Configuration changes are not part of normal operation and should only be performed by trained individuals See Wireless System Setup for a full description of the procedure Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 16 Introduction to the LifeSync Wireless System Power Supply LS 132 The LifeSync Power Supply converts AC power to the 5 5 V DC power required to operate the Lifesync Monitor Transceiver and charge the LifeSync Rechargeable Battery Note When the LifeSync Monitor Transceiver is disconnected from the LifeSync Power Supply or AC power the battery will stop charging and LifeSync Monitor Transceiver will be powered by the rechargeable battery Accessories Telemetry Pouch A Telemetry Pouch LS 213 may be used to protect the LifeSync Patient Transceiver from fluids and other hazardous materials Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual Introduction to the LifeSync Wireless System Introduction to LifeSync Patient Cables and Cable Adapters Patient Cables and Cable Adapters The LifeSync Patient Cables and Cable Adapters provide an interface between the ECG equipment and LifeSync LeadWear Disposables The LifeSync Patient Cables and Cable Adapters permit the use of LeadWear Disposab
51. nen Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 24 LifeSync Wireless System Operation The patient s ECG signal will appear on the cardiac monitor within a few seconds If ECG cardiac monitor is respiration capable the respiration signal will also appear 12 Lead Wireless Monitoring To continuously monitor 12 lead ECG signals using a 12 lead cardiac monitor Confirm LifeSync Monitor Transceiver Settings NOTE Make sure a LifeSync BLUE Token is installed in the token port of the Monitor Transceiver E A 1 Press Power On Off switch to turn Monitor Transceiver ON Ku A LIFESYNc 2 Confirm the indicator 12 LEAD is A VAV illuminated 3 Confirm the BEDSIDE is illuminated a E 3 5 0 BEDSIDE CART SETUP MOVE TOKEN TO PATIENT TRANSCEIVER REMOVE TOKE Apply LifeSync LeadWear Disposable 1 Select appropriate size 5 Lead LeadWear Disposable BLUE connector for the patient refer to size chart on page 10 and Precordial LeadWear Disposable GREEN connector NOTE For placement of LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 12 Lead Monitoring on page 35 of this Manual 2 Insert both BLUE 5 Lead LeadWear and GREEN precordial LeadWear Connectors into BLUE and GREEN slots on Patient Transceiver matching colors Inserting the Lead LeadWear BLUE Connector will t
52. nitor Transceiver will remember the current pairing and there is no need to re synchronize with the LifeSync Patient Transceiver when changing the ECG configuration Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 21 LifeSync Wireless System Operation Configuration of the LifeSync 2 1 Monitor Transceiver for Bedside or Cart Operation 1 Connect LifeSync Monitor Transceiver to LifeSync Power Supply and AC power source 2 Power up Monitor Transceiver by depressing On Off switch 3 Current BEDSIDE permanent monitoring or CART temporary monitoring will be illuminated 4 To change BEDSIDE CART configuration remove the i synchronization BLUE Token from the PATIENT TRANSCENER slot on the Monitor Transceiver 5 Insert the YELLOW Configuration Token into the Token slot 8 The Monitor Transceiver will BEEP 4 times and illuminate the new configuration 9 Remove the YELLOW configuration Token and replace with the BLUE synchronization token RECEIVING ECG NOTE LifeSync Monitor Transceiver will need to re synchronize with the LifeSync Patient Transceiver when changing the BEDSIDE CART configuration Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 22 LifeSync Wireless System Operation User Instructions Wireless Monitoring 5 Lead Wireless Monitoring To continuously monitor 3 lead or 5 lead ECG signals
53. nized with the Patient Transceiver e 8 1 Press Power On Off switch to turn e b CART Monitor Transceiver ON LIFESvN qu 2 Confirm the indicator 5 LEAD or 12 LEAD is illuminated 3 Confirm the CART is illuminated _ MOVE TOKEN TO PATIENT TRANSCEIVER ut MCOVt K N wid NT PTD PATIENT TRANSCEIVER WMT WNT PATE EEE AMD LED Mi IN SETURN TOREN TO MONITO WANSC EINER Cart 12 Lead ECG Only Apply Precordial LeadWear Disposable 1 Select Precordial LeadWear Disposable GREEN connector NOTE For placement of Precordial LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 12 Lead Monitoring on page 35 of this Manual 2 Ensure the V BROWN lead of the 5 Lead LeadWear Disposable already on the patient is in V1 location Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 27 LifeSync Wireless System Operation 3 Insert GREEN precordial LeadWear Connector into GREEN slot on Patient Transceiver Ensure that connector is seated securely and that tabs lock into place Synchronize LifeSync Transceivers 1 Follow instructions in SETUP section of CART Monitor Transceiver y 4 L FESYN qm 2 REMOVE TOKEN Remove BLUE Token the MOVE TOKEN TO PATIENT TRANSCEIVER senior Pronscehvir l indicator will glow SOLID YELLOW CW n 3 INSERT INTO PATIENT TRANSCEIVER Pull t7 the flexible cap away from the
54. not fully inserted or defective curling scratches etc e LeadWear damaged e Trunk cable damaged or disconnected from Cable Adapter or ECG monitor telemetry box e Respiration function not selected on ECG equipment LifeSync 2 1 System User s Manual 56 Maintenance amp Troubleshooting Solution LeadWear blue connector correctly replaced if damaged e Inspect for damage and replace if needed e Check end cap replace Patient Transceiver if damaged e Check lead wire s are free of damage and firmly connected to Monitor Transceiver Replace if damaged e Separate lead wires from AC power source e Check trunk cable for damage or disconnection Replace if damaged e Select proper respiration function settings e Replace Patient Transceiver e Replace Monitor Transceiver e Replace electrode s and ensure proper skin prep and placement e Check LeadWear leads are properly placed alternative placement may interfere with respiration e Ensure that LeadWear Disposable is firmly attached to electrode snaps e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e nspect for damage and replace if damaged e Check trunk cable for damage or disconnection Replace if damaged e Select proper respiration function settings Copyright 2013 LifeSync Corporation LS 216 Rev B SYmptom Adapters No ECG or Respiration Continued Patient Cables and Ca
55. ntained in this document is subject to change without notice LifeSync Corporation makes no Warranty of any kind with respect to this information For more information concerning the LifeSync System contact LifeSync Corporation Fort Lauderdale Florida USA within the US 954 745 3510 Toll Free 866 ECG 3888 866 324 3888 www LifeSyncCorp com Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 66 Technical Specifications Reorder Information Printed copies of this User Manual are available directly from LifeSync Corporation Reorder LS 216 LifeSync System components can be reordered from LifeSync Corporation by calling toll free 866 ECG 3888 866 324 3888 For convenience LifeSync Reorder codes and or Model Numbers appear on all LifeSync System components Copyright 2013 LifeSync Corporation LS 216 Rev B
56. o battery slots battery contacts connector ports and Token ports or any other openings or crevices e Do not immerse any LifeSync System Component in any liquid Cleaning and Disinfecting Patient Cables and Cable Adapters Clean the Patient Cables and Cable Adapters by wiping with a lint free cloth moistened with warm water and mild detergent or soap solution CAUTION Never use oils or strong solvents Allow Patient Cables and Cable Adapters to dry completely after cleaning Disinfect the Patient Cables and Cable Adapters by using a chemical disinfectant such as ethanol propanol or glutaraldehyde Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 49 Maintenance amp Troubleshooting CAUTION Use only recommended cleaning substances and disinfectants Others may cause damage not covered by warranty reduce the useful life of the product or cause safety hazards Cleaning the LeadWear Disposables LifeSync LeadWear Disposables are intended for single patient use only They may be wiped with a nearly dry cloth moistened with warm water If a LeadWear Disposable becomes badly soiled it should be replaced NOTE These recommendations are provided for guidance only The actual cleanliness of devices depends upon techniques and actual cleaning practices employed by the user Copyright 2013 LifeSync Corporation LS 216 Rev B Troubleshooting LifeSync 2 1 Sys
57. ocess receiving ECG SERVICE RED SOLID OR FLASHING Transceiver malfunction service required All leads connected LEAD OFF YELLOW SOLID Check patient leads and electrodes GREEN SOLID Battery is fully charged GREEN FLASHING Battery is charging BATTERY CHARGING AND NOTE The GREEN light only flashes when the unit is connected to the LifeSync Power FUEL GAUGE Supply plugged into AC power Battery charge level low currently operating on lo C 6 YELLOW FLASHING battery and less than 60 minutes operation time remains NOTE The YELLOW light is only active when the unit is NOT connected to the LifeSync Power Supply plugged into AC power A C POWER e3 GREEN SOLID Indicates when A C Power is applied A C LifeSync Rechargeable Battery LS 405 The LifeSync Rechargeable Battery is a 3 6 Volt rechargeable Lithium ion battery and is interchangeable between the LifeSync Patient Transceiver and the LifeSync Monitor Transceiver Batteries are shipped in a partial charge state The LifeSync Battery charges in less than eight hours when installed in a Lifesync Monitor Transceiver that is connected to the LifeSync Power Supply plugged into 110V AC power NOTE If battery is new remember to remove the plastic tape from the battery contacts before first use A new battery will need to be charged in a LifeSync Monitor Transceiver for approximately eight hours before first use Copyright 2013 LifeSync
58. omagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular wireless 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 LifeSync System 2 1 is used exceeds the applicable RF compliance level above the LifeSync System 2 1 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the LifeSync System 2 1 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 64 Technical Specifications Recommended Separation Distances between portable and mobile RF communications equipment and the LifeSync System 2 1 The LifeSync System 2 1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LifeSync System 2 1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Lif
59. r 2 Placethe third partially charged battery in the ECG machine Monitor Transceiver confirming that the plastic film contact cover has been removed 3 Press Power On Off switch Confirm that all indicators light for approximately one second and an audible BEEP is heard this is a user interface test Confirm that the YELLOW Low Battery Charge indicator is flashing and that an audible tone continues to beep 4 Connect the ECG machine Monitor Transceiver to the Power Supply and plug to AC Power 5 nsert the gree configuration Token marked ECG in the Token port on the top of the Monitor Transceiver The Monitor Transceiver will BEEP 4 times and change the ECG mode which will be illuminated on the front panel Confirm that the configuration function is working by performing this operation several times Select ECG 12 Lead mode 6 Insert the yellow configuration Token Marked Bedside Cart into the Token Port on the top of the Monitor Transceiver The Monitor Transceiver will BEEP 4 times and switch between Bedside and Cart Communication Modes Confirm that the configuration function is working by performing this operation several times Select Cart Communication Mode 7 Connect lead wires from the 12 lead ECG machine to the ECG machine Monitor Transceiver matching colors and lead markings 8 Remove Precordial LeadWear Disposable from package and connect electrode snaps on Precordial LeadWear Disposable to Patient Simulator do not conne
60. r and charge battery e Replace power supply e Replace Monitor Transceiver e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replace if damaged e Ensure battery is fully inserted and latched e Replace battery e Check end cap replace Patient Transceiver if damaged e Replace Patient Transceiver Copyright 2013 LifeSync Corporation LS 216 Rev B SYmptom Monitor Transceiver Intermittent On Off Transceivers Red Service light On All LEDs On No or Intermittent Communication sync between Transceivers Patient Transceiver beeping Cause e Power supply not properly connected to Monitor Transceiver or AC outlet e Battery not fully inserted if running on battery e Faulty battery e Faulty power supply e Monitor Transceiver failure e Unit needs servicing e Unit needs servicing e Token not fully inserted on Monitor Transceiver e Patient Transceiver or Monitor Transceiver not turned On e Out of range or at edge of range e Permanent communication will drop briefly 3 to 4 seconds while initiating Cart 12 lead Monitoring e 5 Lead LeadWear blue connector not fully inserted or defective curling scratches etc e End cap damaged e Patient Transceiver failure e Monitor Transceiver failure e Low or faulty battery e Battery not fully inserted LifeSync 2 1 System User s Manual 51 Maintenance amp Troubleshooting Solution e Ensure power
61. raw a small amount of power from the battery even when Monitor Transceiver is turned off If the Monitor transceiver is turned off the AC adaptor is removed and the batteries are stored for more than a month they will need charging Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 47 Maintenance amp Troubleshooting NOTE Storing the battery for a long period of time without use may degrade the battery capacity CAUTION e Store batteries between 10 C and 26 C 50 F and 80 F e Keep batteries in low humidity location with little temperature variation e Keep batteries away from direct sunlight Patient Cables and Cable Adapters Maintenance Before use check that the product is intact and clean WARNING Do not use if you see signs of deterioration or damage Make sure there are no cracks cuts tears or breaks in the insulation and that the connectors are in good condition Use only recommended cleaning substances and disinfectants listed in the cleaning section of this Manual Others may cause damage not covered by warranty reduce the useful life of the product or cause safety hazards CAUTION Never immerse or soak the Patient Cables and Cable Adapters CAUTION Do not sterilize Patient Cables and Cable Adapters by autoclave radiation or steam Always follow and retain the instructions accompanying the cleaning and disinfecting substances you are
62. re BLUE to synchronize the Transceivers GREEN to select 3 5 lead ECG or 12 lead ECG and 1 11 to set between Bedside and Cart Power ON OFF Turn Monitor Transceiver ON with On Off switch ECG Monitor Connections Posts for connection to ECG lead wire set _ Bedside Cart _ Ll Use YELLOW Token to set between Bedside and Cart ECG Use GREEN Token to select 3 5 lead or 12 lead Battery Charge and A C Indicator lt Indicates when connected to A C and amount of remaining charge on battery Battery Latch L7 7 Holds battery in place LifeSync Rechargeable Battery Insert removable battery here for charging A built in battery charger automatically charges the battery whenever the Monitor Transceiver is connected to the LifeSync Power Supply plugged into AC power VISUAL STATUS INDICATORS MONITOR TRANSCEIVER POWER ON OFF SWITCH ON OFF SWITCH Press to turn unit ON or OFF OF 3 5 lead not selected ECG 3 5 GREEN SOLID 3 5 lead selected TT CE TT 12 lead not selected ECG 12 GREEN SOLID 12 lead selected GREEN SOLID Bedside selected OF _ Catnmotsdeted O CART OFF OFF Bedside not selected BEDSIDE OFF Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 14 Introduction to the LifeSync Wireless System SETUP MOVE TOKEN TO PATIENT STATUS RECEIVING ECG YELLOW SOLID GREEN FLASHING Communication in pr
63. rmed individually by PT on all 10 patient electrode connections e Leadoff sensed by Patient Transceiver respectively leadoff electrodes in MT e Leadoff simulated by Monitor Transceiver Leadoff of all electrodes simulated during loss of radio link Leadoff of all electrodes simulated during loss of power to either PT or MT Note Power to leadoff circuit in MT is backed up by internal long life lithium coin cell batteries Be Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual Technical Specifications Specification Pacer Pulse Detection Transmission and Signals on RA LA amp LL channels only are acquired Reconstruction at 16 000 sps and monitored for high slew rates 210 000 mV s When high slew rate is detected a high resolution 6 ms data sample is acquired and transmitted without Captures and transmits 6 ms Detects and transmits pacemaker pulses of amplitude 2 700 mV of duration 0 2 2 0 ms and of amplitude 3 700 mV of duration 0 1 0 2 ms Pacer Pulse Function Trigger Slew Rate Pacer Pulse functions triggers when ECG signal slew rate exceeds 10 000 M Signallatencyduetoradio ss Latency due to radio 500msmaximum ms maximum Operating Battery 3 6 VDC po Capadty _________ 2200 mA hr Technology Rechargeable Lithium Ion Operating Battery Life Patient Transceiver W xHxT W xHxT Storage Temperature 20 to 70 C Atmospheric Pressure 1060 mbar
64. rom the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 24 P IEC 61000 4 6 150 kHz to 80 MHz Radiated BF 3 V m d 1 24 P80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 34 P 8o00 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 fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 2 If operating under conditions according to the EMC standard 60601 1 2 Radiated Immunity 3V m field strengths at this level may cause erroneous measurements of respiration at various frequencies when the LifeSync amp Wireless System is used together with some Monitor Systems The criteria for success that was used for the respiration portion of the LifeSync System 2 1 for radiated immunity 3 V m was oriented toward patient respiration rate monitoring The respiration rate as displayed on the patient monitor tested could not deviate more than 2096 with a 10 second settling time for transmitter switching NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electr
65. s frequently from background noise due to motion artifact EMI etc then pacer pulses could be masked or missed by the LifeSync Wireless System See further disclosure of pace maker pulse detection information in the Technical section on page 59 of this manual The LifeSync Wireless System may decrease the ability of the monitor to detect marginal pacemaker pulses e g pacemaker pulses having amplitudes lt 2 0 mV and or widths lt 0 2 ms If the monitor does not detect the pacemaker pulse then attempt to change the monitored Lead to a Lead exhibiting a larger amplitude pacemaker pulse If changing the monitored Lead does not result in pacemaker pulse detection then switch the patient to a LifeSync Patient Cables and Cable Adapters The LifeSync Wireless System should not be used for external pacing Impedance pneumography detects respiratory effort via changes in chest volume Impedance pneumography can be used to detect central apnea but apnea episodes with continued respiratory effort such as obstructive apnea and mixed apnea may go undetected Artifacts due to patient motion mattress shaking or use of electrocautery equipment may also cause apnea episodes to go undetected Impedance pneumography is not recommended for patients with pacemakers A loss of signal can occur if excess force causes damage to a LifeSync LeadWear Disposable that is stretched due to electrode placement on the patient In the event of an emergency s
66. sceiver or AC outlet resulting in low battery e Battery not fully inserted if running on battery e Faulty battery e Faulty power supply e Monitor Transceiver failure e 5 Lead LeadWear blue connector not fully inserted or defective curling scratches etc e Battery not fully inserted e Faulty battery e End cap damaged e Patient Transceiver failure e Power supply not properly connected to Monitor Transceiver or AC outlet e Battery not fully inserted if running on battery e Faulty battery e Faulty power supply e Monitor Transceiver failure e Battery not fully charged at start when replaced e Battery at end of life or faulty LifeSync 2 1 System User s Manual 52 Maintenance amp Troubleshooting Solution e Check 5 Lead LeadWear connector for damage replace if needed e Check end cap replace Patient Transceiver if damaged e Replace Patient Transceiver e Connect power supply to Monitor Transceiver and AC outlet verify green A C indicator lit e Ensure battery is fully inserted and latched e Replace battery e Replace power supply e Replace Monitor Transceiver e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e Ensure battery is fully inserted and latched e Replace battery e Check end cap replace Patient Transceiver if damaged e Replace Patient Transceiver e Ensure power supply properly connected to Monitor
67. se Telemetry Pouch to protect it from fluids and other hazardous materials In areas where the wireless capability of the LifeSync Wireless System is not in use LifeSync Patient Cables and Cable Adapters are available to connect the LeadWear Disposable s directly to an ECG monitor Copyright 2013 LifeSync Corporation LS 216 Rev B 8 LifeSync 2 1 System User s Manual 9 Introduction to the LifeSync Wireless System Unpacking Checklist 2 1 Patient Transceiver DI LifeSync 2 1 Patient Transceiver Q LifeSync Rechargeable Battery tt in 2 1 Monitor Transceiver LifeSync 2 1 Monitor Transceiver LifeSync Rechargeable Battery LifeSync Blue synchronization Token LifeSync Yellow Bedside Cart configuration Token LifeSync Green 5 12 Lead configuration Token Lifesync Mounting Plate Reference Material CD including User s Manual L1 L1 L1 J Di i E LeadWear Disposable DI LifeSync 5 Lead LeadWear Disposable DI LifeSync Precordial LeadWear Disposable DI LifeSync 12 Lead LeadWear Disposable A printed LifeSync System User s Manual LS 216 is provided when requested Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 10 Introduction to the LifeSync Wireless System System Components LifeSync LeadWear Disposable There are two types of LifeSync LeadWear Disposable 5 Lead LeadWear BLUE For continuous Disposable Connector 5 lead E
68. serted and latched e Charge battery or replace with fully charged battery and ensure it is properly latched e Replace defective battery e Connect power supply to Monitor Transceiver and AC Copyright 2013 LifeSync Corporation LS 216 Rev B Symptom No Intermittent or Noisy Respiration No Intermittent or Noisy Respiration Continued Cause outlet e Monitor Transceiver is Off e Incorrect 5 Lead or 12 Lead ECG mode selected e Lead wire s damaged or poor connections to Monitor Transceiver e Lead wire s too close to AC power source e Trunk cable damaged or not properly connected to lead wires or ECG monitor e Out of range or at edge of range e Token not fully inserted on Monitor Transceiver e Transceivers not synchronized e Motion artifact e ECG monitor not operating properly e Patient Transceiver failure e Monitor Transceiver failure e Electrode s faulty not properly placed or skin not properly prepped e LeadWear leads incorrectly placed e Poor LeadWear Disposable connection to electrode s e LeadWear Blue connector not fully inserted or defective LifeSync 2 1 System User s Manual 55 Maintenance amp Troubleshooting Solution outlet verify green A C indicator lit e Turn Monitor Transceiver On with power on off switch e Ensure proper 5 Lead or 12 Lead ECG mode selected e Check lead wire s are free of damage and firmly connected to Monitor Transceiver Repla
69. ssscccessecccesececeuscecsuseceseecesanscesauaees 22 5 XEead Wireless MONItONNE yk a b ken d Kurdan Kek adan dre P k 68200 22 12 Lead Wireless WMIONILOLING 5 eto dead rrt dh o eb a bene do ape va SEM bA 24 AI e c E 26 Patient Transfer Wireless to Wireless h b eene eme emnes 29 System RemoVdlostss nA Hun K KU AD KK KV aas Doce d KE A eed vago KAN cL H Rud 30 LifeSync R chareeable Batteries ion oe l yen a n V C Da TEM k ka 30 Bo e leri lela T cM 32 User Instructions LeadWear Disposable eesseeeeeen enne 33 SNR Ure alice gil A RTI 33 12 Lead MORItOFIDB nak a k rie ke ek cet ni oo Waa eke iu ee Man ep tai v AR elan 35 LifeSync Patient Cables and Cable Adapters Operation hAhh h A eee 37 User Instructions Patient Cables and Cable Adapters eee 37 12 Lead Patient Gables and Gable AdaDte s i cio arae du ER Pp pao Kin edet S Deb o ERE 37 5 Lead Patient Cables and Cable Adapters M E keke keka 37 Patient Transfer Wireless to Patient Cables and Cable Adapters 38 Maintenance amp TroubleshOotlhig si sla e rien er e e k n le e e v dee a Cre ua 39 System F unctional Check ly Kl ki atendido e Kr is atre Ke K oaths UD t Lt ASTA d A pe ed 39 Requirec EquipImiell ik oed terere dI bara E Po vu VO E Pise ud eth DO v VOR E Pis Uri ETE 39 System Configuration and Functional Check kk keke 42 Rechargeable Battery udi tu a em epe
70. stem 2 1 includes low power Bluetooth class 2 RF transmitters for patient monitoring and diagnosis Although no issues have been observed with coexistence with 802 11 b g equipment the user should be aware that the LifeSync System 2 1 operates in the same frequency band as 802 11 b g The RF band of transmission is 2 400 GHz to 2 4835 GHz The overall band of the signal is 83 5Mhz with 79 channels of adaptive frequency hopping Each channel has a bandwidth of 1 Mhz The maximum radiated output power is 2 5 mW or 4 dBm Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 65 Technical Specifications Manufacturer s Information The LifeSync System is covered by one or more of the following Patents 5 862 803 5 957 854 6 289 238 6 441 747 6 496 705 6 577 893 6 611 705 Additional patents are pending LIFESYNC CORPORATION EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE The LifeSync System complies with UL 60601 1 CSA C22 2 No 601 1 EN 60601 1 and EN 60601 2 27 LifeSync LeadWear Disposables comply with ANSI AAMI EC 53 1995 and EC 53 A1 1998 The LifeSync System 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 The information co
71. supply properly connected to Monitor Transceiver and AC outlet verify green A C indicator lit e Ensure battery is fully inserted and latched e Replace battery e Replace power supply e Replace Monitor Transceiver e Replace Patient Transceiver or Monitor Transceiver e Replace Patient Transceiver or Monitor Transceiver e Fully insert token on Monitor Transceiver and synchronize if needed e Ensure both units are turned On and synchronize if needed e System range exceeded move patient back within 30 feet of Monitor Transceiver e Intermittent condition may last up to 20 seconds if temporary communication cannot be established e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e Check end cap replace Patient Transceiver if damaged e Replace Patient Transceiver e Replace Monitor Transceiver e Re charge battery or replace with fully charged battery e Ensure battery is fully inserted and latched Copyright 2013 LifeSync Corporation LS 216 Rev B Symptom Patient Transceiver beeping Continued Monitor Transceiver beeping Patient Transceiver All LEDs Intermittent On Off Monitor Transceiver All LEDs Intermittent On Off Battery does not last 16 hours on Patient Transceiver or 8 hours on Monitor Transceiver Cause e Turns on and off intermittently e Patient Transceiver failure e Power supply not connected to Monitor Tran
72. t is recommended that batteries be discarded after one year of normal use 400 discharge cycles Recycle or dispose of discarded batteries according to national state and local regulations ke cus MH29577 LIFESYNC CORPORATION 1 866 324 3888 USA www LifeSyncCorp com 2 0 Rechargeable Li ion Battery Rating 3 7V 2 3Ah 8 6Wh HET EA AU CWWYYZZZZ 2410007 DO NOT disassemble crush or puncture short circuit incinerate heat over 60 C Assembied in China CAUTION e Remove the plastic film cover from the battery contacts before using e Do not short the battery terminals e Do not try to connect a LifeSync Rechargeable Battery with any device other than a LifeSync Monitor Transceiver or a LifeSync Patient Transceiver e Do not expose to high temperature above 26 C 80 F WARNING e Do not incinerate submerge crush disassemble or autoclave the battery e Do not recharge or reuse battery that has been submerged discard or recycle it immediately Battery Storage Batteries should be removed from Patient Transceivers and stored separately when not in use for more than a few days NOTE The Patient Transceiver will continue to draw a small amount of power from the battery even when LeadWear Disposables are not connected and all indicators are off If batteries are stored for more than a month they will need charging NOTE The Monitor Transceiver will continue to d
73. tem User s Manual 50 Maintenance amp Troubleshooting In each section start at the top of each solution set and work down Symptom Patient Transceiver won t turn On Monitor Transceiver won t turn On Patient Transceiver Intermittent On Off Cause e 5 Lead LeadWear blue connector not fully inserted or defective curling scratches etc e Battery is discharged or defective e Battery contacts covered e End cap damaged e Patient Transceiver failure e Power supply not connected to Monitor Transceiver or AC outlet e Monitor Transceiver is not On e Faulty AC outlet e Battery contacts covered if running on battery e Faulty power supply e Monitor Transceiver failure e 5 Lead LeadWear blue connector not fully inserted or defective curling scratches etc e Battery not fully inserted e Faulty battery e End cap damaged e Patient Transceiver failure Solution e Remove inspect for damage and replace or reinsert LeadWear Connector correctly replaced if damaged e Charge battery or replace with fully charged battery and ensure it is properly latched e Replace defective battery e Uncover and charge battery e Check end cap replace Patient Transceiver if damaged e Replace Patient Transceiver e Connect power supply to Monitor Transceiver and AC outlet verify green A C indicator lit e Turn Monitor Transceiver On with power on off switch e Use another AC outlet e Uncove
74. tion The LifeSync System will eliminate the wires between the ECG patient and the ECG monitor and will replace the traditional ECG cable with a radio link The LifeSync System will support the standard 5 lead ECG hook up via the Continuous Leadwear for monitoring and has the capability to add the remaining V1 V6 precordial leads via the Discrete Leadwear for 12 lead discrete ECG recording Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 2 Preface CAUTION United States Federal law restricts this device to sale distribution or use by or on the order of a licensed medical practitioner This User Manual is intended for use by trained clinicians who are presumed to be familiar with the use of ECG monitoring equipment and interpretation of vital signs collected and displayed by that equipment The LifeSync Patient Cables and Cable Adapters are intended to be used in conjunction with various patient monitoring equipment such as ECG and EKG Caution Warning Conventions WARNING Calls attention to WARNINGS conditions or practices that could result in personal injury to the patient or the clinician CAUTION Calls attention to CAUTIONS conditions or practices that could result in damage to the equipment or other property NOTE Calls attention to NOTES information of particular importance or assistance to the user Copyright 2013 LifeSync Corporation LS 216 Re
75. token port on Rom N Patient Transceiver and fully insert BLUE Token into token port 4 WAIT UNTIL PATIENT TRANSCEIVER BEEPS AND LED BLINKS A single audible BEEP is produced when BLUE Token is fully inserted and RETURN TOKEN INTO MONITOR TRANSCEIVER indicator on the Patient Transceiver will glow FLASHING YELLOW 5 RETURN TOKEN TO MONITOR TRANSCEIVER as Remove BLUE token from Patient TRANSMITTING ECG Transceiver and close flexible cap over token BEDSIDE CART port the RETURN TOKEN INTO MONITOR TRANSCEIVER indicator on the Patient Transceiver will go off 6 Fully insert the BLUE Token into the token port on the CART Monitor Transceiver The CART Monitor Transceiver will BEEP when the token is properly re inserted and the MOVE TOKEN TO PATIENT TRANSCEIVER indicator will go off 7 Within a few seconds the Transceivers STATUS indicators will display FLASHING GREEN if communicating or SOLID YELLOW if communication failed If communication fails repeat steps 1 thru 5 Patient Transceiver STATUS TRANSMITTING ECG CART indicator and BESIDE indicator will both flash GREEN STATUS TRANSMITTING ECG BEDSIDE CART Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual LifeSync Wireless System Operation Communication in process with both BEDSIDE Monitor Transceiver and CART Monitor Transceiver CART Monitor Transceiver STATUS ST
76. urn the Patient Transceiver ON Ensure that connectors are seated securely and that tabs lock into place 3 Place LifeSync Patient Transceiver inside Telemetry Pouch Pouch can be placed on or near the patient Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 25 LifeSync Wireless System Operation Synchronize LifeSync Transceivers 1 Follow instructions in SETUP section of ere 2 Monitor Transceiver A KT EN LIFESYNc KEMA 2 REMOVE TOKEN Remove BLUE Token the MOVE TOKEN TO PATIENT TRANSCEIVER Monitor Transceiver indicator will glow SOLID YELLOW 3 INSERT INTO PATIENT TRANSCEIVER Pull 1 e the flexible cap away from the token port on uorum c Patient Transceiver and fully insert BLUE Token into token port 4 WAIT UNTIL PATIENT TRANSCEIVER BEEPS AND LED BLINKS A single audible BEEP is produced when BLUE Token is fully inserted and RETURN TOKEN INTO MONITOR TRANSCEIVER indicator on the Patient Transceiver will glow FLASHING YELLOW 5 RETURN TOKEN TO MONITOR TRANSCEIVER Remove BLUE token from Patient TRANSMITTING ECG Transceiver and close flexible cap over token oeosioe cant port the RETURN TOKEN INTO MONITOR TRANSCEIVER indicator on the Patient Transceiver will go off 6 Fully insert the BLUE Token into the token port on the Monitor Transceiver The Monitor Transceiver will BEEP when the token is properly re inserted and the
77. using Dilute according to the Manufacturer s instructions Keep Patient Cables and Cable Adapters free of dust and dirt clean and disinfect the Patient Cables and Cable Adapters after each use Protect the Patient Cables and Cable Adapters from strong UV radiation NOTE LifeSync Patient Cables and Cable Adapters are non sterile reusable and latex free Copyright 2013 LifeSync Corporation LS 216 Rev B LifeSync 2 1 System User s Manual 48 Maintenance amp Troubleshooting Cleaning LifeSync System Components Cleaning the Transceivers Battery and Power Supply The LifeSync Patient Transceiver Monitor Transceiver Rechargeable Battery and Power Supply may be cleaned as needed by wiping with a nearly dry cloth moistened with one of the following cleaning solutions warm water and soap Cidex 7096 isopropyl alcohol Thoroughly wipe off any excess cleaning solution with a dry cloth CAUTION e Do not use the following solvents for cleaning the transceivers butyl alcohol ethanol Freon bleach acetone hydrogen peroxide e Use of any of these solvents may lead to deterioration of plastic components e Do not sterilize by autoclave radiation or steam any LifeSync System Components CAUTION e Transceivers should have batteries installed whenever they are cleaned e Batteries may be cleaned separately but care must be taken to avoid wetting the metal battery contacts WARNING e Do not allow liquid int
78. v B LifeSync 2 1 System User s Manual Symbols Preface The following symbols are used throughout this manual and or may appear on LifeSync Wireless System Components Direct current 19i 6 Input O Non ionizing electromagnetic o radiation l Consult accompanying documents Q Bluetooth Li Lithium ion battery Ec REP Enclosure Protection Drip proof per EN60529 1991 8 C A Expiration Use before N IPX1 Safety Information Patient Connections are Type CF protected against defibrillation Battery should not be disposed of in fire ETL listed product Bluetooth Wireless Technology Authorized representative in the European Community Temperature limitation Manufacturer Serial Number Warnings Explosion Hazard In accordance with UL 60601 1 which applies to all medical equipment do not use this device in the presence of flammable anesthetics In order for the LifeSync LeadWear Disposable to work properly the RL Right Leg GREEN electrode must be connected to the patient at all times with appropriate electrode attached Follow electrode manufacturer s guidelines for skin prep prior to placing electrodes on patient ifeSync LeadWear Disposable is radiolucent Using some digital imaging systems it may be less apparent that LeadWear Disposable and radiolucent electrodes are outside the body When attached to LeadWear Disposable Copyright 20
79. wer On Off switch Confirm that all indicators light for approximately one second and an audible BEEP is heard this is a user interface test Confirm that the GREEN Battery Charging indicator is flashing 5 Confirm the indicator shows ECG 5 Lead mode Confirm the indicator shows Bedside Communication Mode 7 Connect lead wires from the cardiac monitor to the Monitor Transceiver matching colors and lead markings e C Patient Transceiver Set Up Power on Test 1 Insert the fully charged battery into the Patient Transceiver 2 Remove 5 Lead LeadWear Disposable from package Insert 5 Lead LeadWear Connector into connector port matching connector colors and connector keys 3 Confirm that all indicators light for approximately one second and an audible BEEP is heard this is a user interface test Confirm that the Low Battery Charge indicator is OFF 4 Connect electrode snaps on 5 LeadWear Disposable to Patient Simulator D Transceiver Synchronizing Single Bedside 1 Remove blue Token from the Bedside Monitor Transceiver Confirm Insert Token Into Patient Transceiver Status indicator on Monitor Transceiver glows SOLID YELLOW 2 Insert Token into Token port on the side of Patient Transceiver Wait for Return Token To Monitor Transceiver Status indicator on Patient Transceiver to FLASH YELLOW Confirm that Patient Transceiver produces a single BEEP when Token is fully seated 3 Remove Token from Patient Transceiver Confirm th
80. ystem if any system component appears damaged or appears not to function properly See System Functional Check section of this manual for procedure to verify normal operation If either of the LifeSync Transceivers detects an unrecoverable fault the RED Service LED will illuminate continuously indicating that service is required prior to use of the LifeSync Transceiver Do not attempt to use a LifeSync Transceiver that indicates service is required When RED service LED is on the LifeSync Wireless System will stop working The LifeSync Wireless System can remain applied to a patient during defibrillation The ECG signal will be interrupted for no more than a few seconds during defibrillation The LifeSync Wireless System should not be used to perform a synchronized cardio version due to signal latency in the radio transmission The LifeSync Wireless System can be used during procedures using electrosurgery machines However even though the LifeSync Transceivers contain electrosurgical interference suppression filters increased noise will likely be present while an electrosurgery device is in use Location of the electrosurgery return pad is very important to minimize interference be sure to follow electrosurgical manufacturer s guidelines This effect can be reduced by selecting low impedance electrodes and ECG electrode sites that are remote from the surgical site and electrosurgical return Avoid electrosurgical surgery burns at t

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