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1. IPX1 Temperature limitation Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 3 Preface Safety Information 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 LifeSync 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 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
2. Disposable on patient refer to User Instructions LeadWear Disposable for 12 Lead Monitoring on page 31 of this Manual 2 Remove the V BROWN snap of the 3 5 Lead LeadWear Disposable already on the patient from its electrode if used 3 On the Patient Transceiver pull the flexible cap away from connector port and insert GREEN Precordial LeadWear Connector into slot on Patient Transceiver Synchronize LifeSync Transceivers 1 Remove Token from secondary Monitor Transceiver The Insert Token Into Patient Transceiver indicator on the Monitor Transceiver will glow SOLID YELLOW 2 Pull the flexible cap away from the token port on Patient Transceiver and fully insert token into token port Wait for the Return Token Into Monitor Transceiver indicator on the Patient Transceiver to glow FLASHING YELLOW The Patient Transceiver will also produce a single audible BEEP when the Token is properly seated Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 24 LifeSync Wireless System Operation 3 Remove token from Patient Transceiver and close flexible cap over j token port the Return Token Into Monitor Transceiver indicator on the Patient Transceiver will go off 4 Fully insert the token into the token port on the secondary Monitor Transceiver The secondary Monitor Transceiver will BEEP when the token is properly re inserted and the Insert Token Into Patient
3. System User s Manual 19 LifeSync Wireless System Operation User Instructions Wireless Monitoring 3 5 Lead Wireless Monitoring To continuously monitor 3 lead or 5 lead ECG signals using a cardiac monitor Select LifeSync Monitor Transceiver Settings NOTE Make sure a LifeSync Token is installed in the token port of the Monitor Transceiver Transceiver ON 2 Press ECG Mode switch until the indicator 3 5 LEAD glows GREEN 3 Press Communication Mode switch until the indicator PERM glows GREEN 1 Press Power On Off switch to turn Monitor Apply LifeSync LeadWear Disposable 1 Select appropriate size 3 5 Lead LeadWear Disposable BLUE connector for the patient refer to size chart on page 9 NOTE For placement of LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 3 5 Lead Monitoring on page 29 of this Manual 2 Insert BLUE 3 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 Place LifeSync Patient Transceiver inside Patient Transceiver Pouch or Armband and seal the top of the pouch Pouch can be placed on or near the patient Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 20 LifeSync Wireless System Operation Synchronize LifeSync Tran
4. damaged Copyright 2008 LifeSync Corporation LifeSync System User s Manual 48 Maintenance amp Troubleshooting Solution e Replace defective battery e Connect power supply to Monitor Transceiver and AC outlet verify green light on Charging indicator e Turn Monitor Transceiver On with power on off switch e Ensure proper 3 5 Lead or 12 Lead ECG mode selected e Check lead wire s are free of damage and firmly connected to 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 LS 164 Rev 7 08 Symptom Intermittent ECG Artifact and Noise Continued No Intermittent or Noisy Respiration Cause e End cap damaged e Battery not fully inserted e Patient Transceiver battery is discharged or defective e Power supply not connected to M
5. 58 Technical Specifications Guidance and manufacturer s declaration electromagnetic immunity The LifeSync System is intended for use in the electromagnetic environment specified below The customer or the user of the LifeSync System should assure that it is used in such an environment Conducted RF 3 Vrms Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the LifeSync System including cables than the recommended separation Radiated RF 3 V m distance calculated from the equation IEC 61000 4 3 80 kHz to 2 5 GHz applicable to the frequency of the transmitter Recommended separation distance d 1 17VP m d 1 17VP 80 MHz to 800 MHz d 2 33VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b See note on Interference may occur in the vicinity of respiration function equipment marked with the following at levels 1 5 V m in symbol RADIO ICON respiration section NOTE1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by
6. Disposable One 3 5 Lead LeadWear Disposable and 12 Lead One Precordial LeadWear Disposable One Precordial LeadWear Disposable LeadWear connectors are color coded to ensure proper connection to the LifeSync Patient Transceiver BLUE connectors on the 3 5 Lead LeadWear Disposable and GREEN connectors on the Precordial LeadWear Disposable NOTE LifeSync LeadWear Disposables are non sterile Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 10 LifeSync System User s Manual 11 Introduction to the LifeSync Wireless System Patient Transceiver LifeSync LeadWear Connector Ports Color coded ports for attachment of the LeadWear Disposable BLUE for the 3 5 Lead LeadWear Disposable and GREEN for the Precordial LeadWear Disposable The Precordial LeadWear connector port is protected by a flexible cap while not in use pon TOREN TO MONITOR TAAMCHYER m LifeSync Token Port Insert the Token here to synchronize the Transceivers The Token port is protected by a flexible cap when not in use LifeSync Smart Battery Battery is removable for charging in the Monitor Transceiver Battery Clips Hold battery in place Turn Patient Transceiver ON by inserting a BLUE 3 5 Lead LeadWear Connector into the BLUE connector port Return Token to Monitor Return Token to Transceiver W FLASHIN Monitor Transceiver VEMM ene The Transceiver will BEEP once wh
7. Pulse Rejection with Overshoot per EC13 2002 section 4 1 4 2 Pacemaker Pulse Rejection with Overshoot Description HR Accuracy Pulses Pulses 2 100 mV 100 700 mV 100 500 us 0 5 2 0 ms Pacemaker Pulses Rejects approx gt 95 of Rejects approx gt 75 of ventricular or A V sequential pacemaker pulses pacemaker pulses with no QRS Rejects approx gt 95 of Rejects approx gt 75 of ventricular or A V sequential pacemaker pulses pacemaker pulses Rejects approx gt 95 of Rejects approx gt 75 of ventricular or A V sequential pacemaker pulses pacemaker pulses Caution The LifeSync System may miss pacer pulses if high background noise is present The LifeSync System captures signal spikes regardless of whether spikes are due to noise or pacer pulses If the LifeSync System triggers frequently from background noise due to motion artifact EMI etc then pacer pulses could be masked or missed by the LifeSync System Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 56 Technical Specifications communications equipment and the LifeSync System The LifeSync System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LifeSync System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the L
8. S iris 8 AG WV Cale IS OOS el tol S y aren k y ser K ae KEWE ra N a wla eet oen ER Dn du A Deed w y lek n 8 System COMPONENTS Kasek sitcom eo OP N E ER NR ME a S0 k RD EKE K KO 6We KEN WES SEBR KED N Unidos 9 Ledd Wear Disposable duy ee ibe iiss ler K e i er dibete e kat r aa er Aa 9 3 5 Lead LeadW Gat Disposable disc hell way K tee e ey e l 9 Precordial Lead LeadWear Disposable k 10 12 Lead LeadWear DiSspoSa Dl pta hr o ee e des i ee b e d ces de er aa es 10 Patent rans CoVVe E 11 WONTON DFARS CEIVED siy y aa E E T EEE E 12 SMart Batt e ES E A N E 13 OK a epee EC 14 POWET SUPPI den TT MR 14 ACCES SONOS Aye k T E 15 Patient Transceiver PO Ul ats s seco an erani a iura tva mo psa m Qno bei irit 15 AED l o NE N VE aene decorata doors Se oA ce ue nte a a N ee 15 Ititiod ctotito the BireSyne Adaptec e ere oce eie y ndi e Ford dd Po a erbe cec va NAV 16 LifeSync Wireless System Operation iet ior et beet iet e Gl eae eei d Sx i rs 17 Wireless oys teni eti D ossa etes Ron ae PER Sere dei etim rn ic espe dre uS dM ce UE NEUES 17 Install Check Smart Batteries in Transceivers k keke eke kO 17 Mount the Lifesync Monitor Transceiver EEl kk keke keke 18 User Instructions Wireless MONitoring cccccssccccssececcssececsssceceeseceeeecesausceesencessees 19 3 5 Lead Wireless MODItOFIBB 44 4 4454 53i4a54454 5420445825 poste ei
9. Status indicator will flash GREEN Permanent Communication still established with the primary Monitor Transceiver TEMP Communication Status indicator will go off Primary Monitor Transceiver Communication Status indicator will flash GREEN Communication in process with Patient Transceiver Secondary Monitor Transceiver Communication Status indicator will flash YELLOW No Communication Temporary 12 Lead ECG Only Remove Precordial LeadWear Disposable 1 Disconnect the GREEN Connector from the Patient Transceiver The Precordial LeadWear Disposable may now be removed from the patient or may be left in place for a future use If necessary replace the V BROWN lead of the 3 5 Lead LeadWear Disposable NOTE Place ECG lead electrode on V BROWN lead before placing on patient Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 26 LifeSync Wireless System Operation 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 Select Transceiver Settings NOTE Make sure a LifeSync Token is installed in the token port of the LifeSync Monitor Transceiver 1 Press Power On Off switch to turn the extra Lifesync Monitor Transceiver ON This is the transceiver attached to the monitor that the patient is being transferred to
10. System complies with Part 15 of the FCC rules Patient Transceiver FCC ID QXQ A2005 PTO1 Monitor Transceiver FCC ID QXQ A2006 MTO1 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 Ec rer Quality First International Limited Suites 317 318 Burford Business Centre 11 Burford Road Stratford London United Kingdom E15 2ST The information contained 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 61 Technical Specifications Reorder Information Printed copies of this User Manual are available directly from LifeSync Corporation Reorder LS 164 Rev 7 08 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 2008 LifeSync Corporation LS 164 Rev 7 08
11. 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 Propaq 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 If operating under conditions according to the EMC standard 60601 1 2 Radiated Immunity 3V m field strengths above 1 5 V m may cause erroneous measurements of respiration at various frequencies when the LifeSync Wireless System is used together with the Welch Allyn Propag Series Monitor Systems Therefore if it is of critical and clinical importance to monitor respiration it is recommended to avoid the use of electrically radiating equipment such as electrocautery surgical pencils and high powered portable and mobile RF communications equipment while the LifeSync Wireless System is being used with the Propaq Monitor However if respiration must be monitored in the Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual Preface presence of high frequency electrically radiated equipment always monitor and set alarms for SpO2 when using the LifeSy
12. indicator will flash GREEN Communication in process with Patient Transceiver 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 Temporary ECG Temp mode allows a single Patient Transceiver to communicate with two Monitor Transceivers simultaneously to monitor 3 lead 5 lead or 12 lead ECG signal NOTE This procedure requires a secondary LifeSync Monitor Transceiver to be set up on a second ECG device Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 23 LifeSync Wireless System Operation Select LifeSync Monitor Transceiver Settings NOTE e Make sure a LifeSync Token is installed in the token port of the Monitor Transceiver e Do not change any settings on the primary Monitor Transceiver The primary Monitor Transceiver is the unit that is already synchronized with the Patient Transceiver 1 Press Power On Off switch to turn ON the secondary Monitor Transceiver 2 Press ECG Mode switch until the desired mode either 3 5 LEAD or 12 LEAD glows GREEN 3 Press Communication Mode switch until the indicator over TEMP glows GREEN Temporary 12 Lead ECG Only Apply Precordial LeadWear Disposable 1 Select appropriate size Precordial LeadWear Disposable GREEN connector NOTE For placement of Precordial LeadWear
13. 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 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 Inspect for damage and replace LS 164 Rev 7 08 Symptom Adapter No ECG or Respiration Continued Adapter Intermittent Noisy ECG or Respiration Cause e Trunk cable damaged or disconnected from Adapter or ECG monitor telemetry box e Respiration function not selected on ECG equipment e ECG monitor or telemetry box not operating properly e Adapter Failure housing damage broken wire s socket damage plug damage etc e El
14. on Charging indicator 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 Select correct TEMP PERM Communication Mode and Synchronize transceivers 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 LS 164 Rev 7 08 Symptom Patient Transceiver beeping Monitor Transceiver beeping Patient Transceiver All LEDs Intermittent On Off Monitor Transceiver All LEDs Intermittent On Off Cause e Low or faulty battery e Battery not fully inserted e Turns on and off intermittently e Patient Transceiver failure e Power supply not connected to Monitor Transceiver 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 3 5 Le
15. only to those monitors that have been validated for compatibility with the LifeSync Wireless System Refer to the Cautions section of this manual for a list of validated monitors or 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 Transceivers smart batteries and power supply frequently Do not operate the LifeSync Wireless System 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 Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 4 Preface 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
16. Corporation LifeSync System User s Manual C 0086 LifeSync Corporation One East Broward Boulevard Suite 1701 Fort Lauderdale Florida 33301 U S A Copyright 2008 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 Bluetooth is a trademark owned by Bluetooth SIG Inc USA and licensed to LifeSync Corporation www LifeSyncCorp com Table of Contents METIDO T UIT 1 WUE TO GUNG UI OMAN reicinn T OU RETE 1 indications Tor 5 sya duyan ya N uate ia n paka a na dk dake YA Wa ehe din 1 CONCINNA UON c n N MN DD DD e N cue 1 Intended Use of LifeSync Wireless System Elike kek ke 1 Caution7 Warning CONVENTIONS sciret ci Ex EE EsRa S Sex teste teni cec morie be h k k EYN 2 SX NNO Ol SO YD YD LEMMA 2 SATCLY dila lel ara zil le ee a 3 WAL INES Salen ke ne Wek n 3 CIOS NEN D 5 NOTOS yana CH HEY 6 Introduction to the LifeSync Wireless System Mh kk enne 7 SY SECM Sal P 7 Unpacking Checklist su ys m ne en ke kelaya r nas haere k n nebana aie bana edi en aa n na desear 8 PATIL TANS CEI VE L rcc 8 Monit r Transceiver scii aside et eee udi d na e Da rl n b ne m cepe a De DARE
17. Corporation LS 164 Rev 7 08 LifeSync System User s Manual 5 Preface undetected Impedance pneumography is not recommended for patients with pacemakers Aloss 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 situation 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 When disconnecting the LifeSync Adapter pull on the plug itself not on the cable Cautions The smart 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 smart battery contacts before using Do not autoclave LifeSync Wireless System components or LifeSync Adapter Do not submerge LifeSync Wireless System components or LifeSync Adapter in any liquid LifeSync LeadWear Disposable is radiolucent Areas of the circuit may show shadows on x ray or under fluoroscopic 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
18. 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 2 Attach recommended electrode s to all snaps except for V BROWN on 3 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 3 5 Lead LeadWear Disposable Electrode Placement LA Left shoulder LL Red Left side of chest below navel NOTE Place electrode V2 first See chart for remaining electrode placements Precordial LeadWear Disposable Electrode Placement mm Fourth intercostal space at right sternal border Fourth intercostal space at left sternal border Midway between V2 and V4 Fifth intercostal space midclavicular line V5 Orange At horizontal level of V4 left anterior axillary line At horizontal level of V4 left midaxillary line Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 33 LifeSync Wireless System Operation NOTE Although the V lead on the 3 5 LeadWear Disposable is not used for 12 lead operation it should be fastened to the patient s chest in order to
19. Transceiver indicator will go off NOTE There will be a momentary interruption in the signal being received by the primary Monitor Transceiver when the Token is placed back in the secondary Monitor Transceiver 5 Within a few seconds the Transceiver indicators will display FLASHING GREEN if communicating or SOLID YELLOW if communication failed If communication fails repeat steps 1 thru 5 Patient Transceiver Both PERM and TEMP Communication Status indicators will flash GREEN Permanent Communication in process with the primary Monitor Transceiver and Temporary Communication with the secondary Monitor Transceiver COM A ep Lir riz Primary and Secondary Monitor Transceivers Communication Status indicator will flash GREEN Communication in process with Patient Transceiver The patient s ECG signal will then appear on both the ECG devices NOTE Temporary and Permanent communication modes are independent and can be run without the other 6 The Patient Transceiver will communicate with the secondary Monitor Transceiver for two minutes Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 25 LifeSync Wireless System Operation 7 After two minutes the Patient Transceiver will automatically end communication with the secondary Monitor Transceiver The Transceiver indicators will reflect the change in communication status Patient Transceiver PERM Communication
20. a K SA 61 LifeSync 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 cardioversion 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 patient electrocardiograph ECG signals which are displayed on the ECG monitors of various manufacturers ECG systems It can be used by clinicians to facilitate ECG monitoring of ambulatory and non ambulatory adult patients in health care facilities by removing the conventional cable connection between the patient and the ECG monitor 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
21. absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the LifeSync System is used exceeds the applicable RF compliance level above the LifeSync System 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 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 59 Technical Specifications Guidance and manufacturer s declaration electromagnetic emissions The LifeSync System is intended for use in the electromagnetic environment specified below The customer or the user of the LifeSync System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The LifeSync System uses RF CISPR 11 energy only for its internal function Therefore its RF emissions are very low and are not lik
22. acility purchase order LifeSync Patient Transceiver installed in the Patient Transceiver Lifesync Monitor Transceiver LifeSync Smart Battery installed in the Monitor Transceiver LifeSync Token installed in the Monitor Transceiver Lifesync Mounting Plate Lifesync Power Supply User s Manual CD LifeSync Precordial LeadWear Disposable LifeSync 12 Lead LeadWear Disposable Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 8 LifeSync System User s Manual 9 Introduction to the LifeSync Wireless System System Components LifeSync LeadWear Disposable There are two types of LifeSync LeadWear Disposable Used in combination with the 3 5 Lead LeadWear Disposable for a 12 lead ECG monitoring Precordial LeadWear GREEN Disposable Connector 3 5 Lead LeadWear Disposables Fans Sie Description RAIA wu us s n o 10 32 18 20 126 9 _xxL 1 1 133 225 19 21 Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual Introduction to the LifeSync Wireless System Precordial LeadWear Disposables Precordial LeadWear Disposables LS 232 7 Large 1 0 4 75 2 5 2 25 3 0 3 0 s ee ee ee ENA LS 233 XXL 1 0 4 75 2 5 229 4 5 4 0 Gt ee 12 Lead LeadWear Disposables 12 Lead LeadWear Disposables LeadWear Disposables are packaged three ways 3 5 Lead One 3 5 Lead LeadWear
23. ad LeadWear blue connector not fully inserted or defective curling scratches etc e Battery not fully inserted e Faulty battery e End cap damaged 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 Copyright 2008 LifeSync Corporation LifeSync System User s Manual 46 Maintenance amp Troubleshooting Solution e Re charge battery or replace with fully charged battery e Ensure battery is fully inserted and latched e Check 3 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 light on Charging indicator 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 Ensure power supply properly connected to Monitor Transceiver and AC outlet verify green light on Charging indicator e Ensure battery is fully inserted and latched e Replace battery e Replace power supply LS 164 Rev 7 08 Symptom Battery does not la
24. and will become the primary Monitor Transceiver 2 Press ECG Mode switch on this transceiver until the indicator glows GREEN for the appropriate ECG mode 3 5 LEAD or 12 LEAD 3 Press Communication Mode switch until the indicator over PERM glows GREEN Synchronize LifeSync Transceivers 1 Remove Token from extra Monitor Transceiver and place in token port on the Patient Transceiver wait for the BEEP Remove token replace flap place token back in extra Monitor Transceiver wait for BEEP NOTE Step by step instructions for 3 5 LEAD wireless monitoring are found on page 18 Step by step instructions for 12 LEAD wireless monitoring are found on page 20 Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 27 LifeSync Wireless System Operation 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 from Patient Transceiver Pouch or Armband 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 4 Discard LeadWear Disposable electrodes and Patient Transceiver Pouch Armband 5 Store Patient T
25. aning and disinfecting substances you are using Dilute according to the Manufacturer s instructions Keep adapter free of dust and dirt clean and disinfect the adapter after each use Protect the adapter from strong UV radiation NOTE LifeSync Adapters are non sterile reusable and latex free Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 42 Maintenance amp Troubleshooting Cleaning LifeSync System Components Cleaning the Transceivers Battery and Power Supply The LifeSync Patient Transceiver Monitor Transceiver Smart 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 Fantastik Cidex 70 isopropyl alcohol T B Q Calgon Corp 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 into battery slots battery contact
26. 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 cardioversion 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 the ECG electrodes sites by ensuring proper connection of the electrosurgery return pad so that the return path cannot be made through the 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 pati
27. ation Customer Service toll free at 866 ECG 3888 866 324 3888 or email us at CustomerService LifeSyncCorp com Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 52 Maintenance amp Troubleshooting Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 53 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 3 5 LEAD MODE 12 LEAD MODE continuous diagnostic ECG monitoring Number of Channels single ended wrt RL J4 _ 9 j 3 U Leadoff Sense Current 50 nA for LL LA RA V V1 V6 Ce tire SPARE Frequency Response Method A per EC11 1991 DC 40 Hz 0 0 0 25 dB 40 150 Hz 0 0 1 dB Triangle Response Method D per EC13 2002 10 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 lt 0 5 maximum 0 1 maximum DC 150 Hz with M Allyn Propaq per EC13 2002 Leadoff Leadoff sensing performed 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 Transceive
28. 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 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 34 LifeSync Adapter Operation LifeSync Adapter Operation User Instructions Adapters 12 Lead Adapter To use LeadWear Disposable directly with 12 Lead ECG monitoring equipment 1 Select appropriate size 3 5 Lead LeadWear Disposable BLUE connector and appropriate size precordial LeadWear Disposable for the patient refer to size chart on page 9 NOTE For placement of LeadWear Disposable on patient refer to User Instructions LeadWear Disposable for 12 Lead Monitoring on page 31 of this Manual Ensure the monitor is set for 12 Lead monitoring 2 Connect Adapter to the trunk cable or monitoring equipment 3 Connect the LeadWear Disposables BLUE and GREEN connector to the Adapter 3 5 Lead Adapter To use LeadWear Disposable directly with ECG monitoring equipment 1 Select appropriate size 3 5 Lead LeadWear Disposable BLUE connector for the patient refer to size chart on page 9 NOTE For placement of LeadWear Disposable on patient refer to User Instructio
29. 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 Adapter is intended to be used in conjunction with various patient monitoring equipment such as ECG and EKG Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 2 Preface 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 Symbols The following symbols are used throughout this manual and or may appear on LifeSync Wireless System Components Patient Connections are Type CF protected against defibrillation Direct current 6 Battery should not be Input M disposed of in fire Non ionizing t ETLI q electromagnetic radiation l keka diwana Consult accompanying dk Bluetooth Wireless documents Q Bluetooth Technology T Authorised representative in Li Lithium ion battery ec REP ha Ell oe i GOL Enclosure Protection Drip proof per EN60529 1991 K Expiration Use before id Manufacturer XXXXXXXXXXXXXX serial no
30. c 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 14 Introduction to the LifeSync Wireless System A new fully charged battery will power a LifeSync Patient Transceiver for a maximum of 24 hours and a LifeSync Monitor Transceiver for a maximum of 12 hours At end of life smart 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 Smart Battery Charge Indicator Easy to read gauge on end of battery indicates amount of charge remaining Press button to view level Each LED represents 2096 of the battery life Token The LifeSync Token is used to establish communication or synchronize the LifeSync Patient Transceiver and LifeSync Monitor Transceiver The 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 Token Token should remain in Token port of the LifeSync Monitor Transceiver at all times except wh
31. crete or ceramic tile If IEC 61000 4 2 8 kV air floors are covered with synthetic material the relative humidity should be at least 30 96 Electrical fast 2 kV for power supply Complies Mains power quality should be transient burst lines that of a typical commercial or hospital environment IEC 61000 4 4 1 kV for input output lines Surge 1 kV differential Complies Mains power quality should be mode that of a typical commercial or IEC 61000 4 5 hospital environment 2 kV common mode Voltage dips short lt 5 96 UT gt 95 96 dip in Complies Mains power quality should be interruptions and voltage UT for 0 5 cycle that of a typical commercial or variations on power supply hospital environment If the input lines 40 96 Ur 60 96 dip in user of the LifeSync System UT for 5 cycles requires continued operation during power mains interruptions it is recommended that the LifeSync System be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz Complies Power frequency magnetic magnetic field fields should be at levels characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE Ur is the AC main voltage prior to application of the test level IEC 61000 4 11 70 96 Ur 30 96 dip in UT for 25 cycles lt 5 96 UT gt 95 96 dip in UT for 5 sec Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual
32. d an audible BEEP is heard this is a user interface test Confirm that the GREEN Battery Charging indicator is flashing Press ECG Mode switch several times confirming that both indicators function Select ECG 3 5 Lead mode Press Communication Mode switch several times confirming that both indicators function Select PERM Communication Mode 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 2 4 Insert the fully charged battery into the Patient Transceiver Remove 3 5 Lead LeadWear Disposable from package Insert 3 5 Lead LeadWear Connector into connector port matching connector colors and connector keys 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 Connect electrode snaps on 3 5 LeadWear Disposable to Patient Simulator D Transceiver Synchronizing Single Permanent 1 Remove Token from the cardiac Monitor Transceiver Confirm Insert Token Into Patient Transceiver Status indicator on Monitor Transceiver glows SOLID YELLOW 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 Remove To
33. e pouch Pouch can be placed on or near the patient Synchronize LifeSync Transceivers 1 Remove token from Monitor Transceiver The Insert Token Into Patient Transceiver indicator on the Monitor Transceiver will glow SOLID YELLOW Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 22 LifeSync Wireless System Operation 2 Pull the flexible cap away from the token port on Patient Transceiver and fully insert token into token port Wait for the Return Token Into Monitor Transceiver indicator on the Patient Transceiver to glow FLASHING YELLOW The Patient Transceiver will also produce a single audible BEEP when the Token is properly seated 3 Remove token from Patient Transceiver and close flexible cap over token port the Return Token Into Monitor Transceiver indicator on the Patient Transceiver will go off 4 Fully insert the token into the token port on the Monitor Transceiver The Monitor Transceiver will BEEP when the token is properly re inserted and the Insert Token Into Patient Transceiver indicator will go off 5 Within a few seconds the Transceivers Communication Status indicators will display FLASHING GREEN if communicating or SOLID YELLOW if communication failed If communication fails repeat steps 1 thru 5 Patient Transceiver PERM Communication Status indicator will flash GREEN Communication in process with Monitor Transceiver Monitor Transceiver Communication Status
34. 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 LS 164 Rev 7 08 Symptom Monitor Transceiver Intermittent On Off Transceivers Red Service light On All LEDs On No or Intermittent Communication synch between Transceivers 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 Monitor Transceiver Communication Mode TEMP PERM mode was pressed 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 Temporary 12 lead Monitoring e 3 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 Copyright 2008 LifeSync Corporation LifeSync System User s Manual 45 Maintenance amp Troubleshooting Solution e Ensure power supply properly connected to Monitor Transceiver and AC outlet verify green light
35. easing the battery clips and sliding the smart battery out of the battery slot Insert the replacement smart battery with contacts and wide part of battery cap toward front of Transceiver Secure the battery clips NOTE Exchanging smart batteries does not require re synchronization of the Transceivers Charging Smart 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 smart battery reaches full charge in less than eight hours NOTE At end of life smart 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 CAUTION Use only a LifeSync Monitor Transceiver to recharge the battery Monitor Transceiver Battery Charging Indicator The Battery Charging indicator on the front of the Monitor Transceiver displays a GREEN light when the battery charger function is active When the Monitor Transceiver is not connected to the Power Supply and plugged to AC power and is being powered by a smart battery the battery charger function is inactive and the Battery Charging indicator will not be lit Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 28 LifeSync System User s Manual 29 LifeSync Wireless System Operation When the Monitor Transceiver is connected to the Power Supply and plugged to AC power and
36. ectrode 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 Adapter or ECG monitor telemetry box e ead wire s too close to AC power source e ECG monitor or telemetry box not operating properly e Adapter Failure housing damage broken wire s socket damage plug damage etc LifeSync System User s Manual 51 Maintenance amp Troubleshooting Solution if damaged e Check trunk cable for damage or disconnection Replace if damaged e Select proper respiration function settings e Check ECG monitor or telemetry box e Replace 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 Inspect for damage and replace if damaged e Check trunk cable for damage and proper connection Replace if damaged e Separate lead wires from AC power source e Check ECG monitor or telemetry box e Replace Adapter If problem cannot be resolved contact LifeSync Corpor
37. eeee 37 Patient Transceiver Set Up Power on TeSt ssssssssseeeeeceecccccsseseeeeeeeeeeeeeeeesesseeeees 37 Transceiver Synchronizing Single Permanent eese 37 Monitor Transceiver Set Up Temporary 12 Lead eese 38 Transceiver Synchronizing Temporary 12 Lead E erze 38 Transceiver Confirm Low Battery Charge Indicators on Patient Transceiver 39 SMa CSV m e NR 40 DA EIS inso sd unc oa befand adt adio uti taa tlt ocu wa mte uten 40 BaLtery StI coi otia I Pea bt pt Rein E pta tae e 40 Adapter MalbitelialiCB sns dsetuesesits teri dept reper Dat oss m GO e e Dub dtu sectas os XANA KAKA Ke NA 41 Cleaning LifeSync System Components sees nnns 42 Cleaning the Transceiver Battery and Power SuDD V zU 42 Cleaning Disinfecting and Sterilizing the Adapters S k EE E 42 Cleaning the LeadWear DisposableS E keke ek ka 43 Troubleshooting norrir MT 44 Patient Transceiver Won t CULTE OM xil ki ke 13y 251 ue E edt pu d ou 44 Monitor Transceiver won t turn On i i lt iiol ala lay day k nan ka k da i nnns nns 44 Patient Transceiver Intermittent On O T keke kk ke nie 44 Monitor Transceiver Intermittent On Off keke kek keke kk KA 45 Transceivers Red Service Went On 3k yl len kaleki l bayk ar n ian ane dub r n k n TREO la 45 AVCED MT cT nesi Siya cen VU yan kd 45 No
38. ely to cause any interference in nearby electronic equipment RF emissions Class B The LifeSync System is CISPR 11 suitable for use in all establishments including Harmonic emissions Class A domestic establishments and IEC 61000 3 2 those directly connected to the public low voltage power Voltage fluctuations flicker Complies supply network that supplies emissions IEC 61000 3 3 buildings used for domestic purposes Note The LifeSync Transceivers each contain a Class 2 Bluetooth technology radio that transmits at 2 40 2 48 GHz Although no interference is likely during installation equipment in the vicinity of the LifeSync System should be monitored for continued proper operation in the presence of the Bluetooth transmitters Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 60 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 1999 5 EC 93 42 EEC The LifeSync
39. en Token is fully inserted Communication Status one for TEMP YELLOW SOLID mode one for PERM We GREEN FLASHING Communication in process mode YELLOW FLASHING Low Battery Charge accompanied by periodic BEEPS Battery charge level low less than 60 minutes operation time left Service uM Transceiver malfunction FLASHING Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 12 Introduction to the LifeSync Wireless System Monitor Transceiver LifeSync Token Port Insert the Token here to synchronize the Transceivers Power On Off Turn Monitor Transceiver ON with On Off switch ECG Monitor Connections Snaps for connection to ECG lead wire set ECG Mode Switch between 3 5 lead and 12 lead ECG monitoring functions Communication Mode Switch between temporary and permanent communication LifeSync Smart Battery Insert removable battery here for charging and for use with portable monitors A built in battery charger automatically charges the battery whenever the Monitor Transceiver is connected to the LifeSync Power Supply plugged into AC power Battery Clips Hold battery in place Insert Token Into Patient Insert Token Into YELLOW SOLID OR Transceiver Patient Transceiver FLASHING The Transceiver will BEEP when Token is fully inserted Hy Communication Status uS GREEN FLASHING Copyright 2008 LifeSync Cor
40. en it is being used to synchronize a LifeSync Patient Transceiver Power Supply 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 Smart 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 smart battery Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 15 Introduction to the LifeSync Wireless System Accessories Patient Transceiver Pouch The LifeSync Patient Transceiver Pouch protects the LifeSync Patient Transceiver from fluids and other hazardous materials Armband The LifeSync Armband is for use when the LifeSync Patient Transceiver needs to be secured to the patient s arm i e stress test etc Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 16 Introduction to the LifeSync Adapter Introduction to LifeSync Adapter Adapters The LifeSync Adapter is an interface between the ECG equipment and LifeSync LeadWear Disposables The LifeSync Adapter permits the use of LeadWear Disposables with ECG monitoring equipment via direct electrical connection NOTE LifeSync Adapters are connected directly to the trunk cable of 3 5 or 12 lead ECG monitors as well a
41. ent applied parts should not contact any other conductive parts including earth ground at any time LifeSync Wireless System and LifeSync Adapter 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 Adapter 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 triggers 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 rejection information in the Technical section on page 45 of this manual 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 Copyright 2008 LifeSync
42. ged 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 LS 164 Rev 7 08 Symptom No Intermittent or Noisy Respiration Continued Adapter No ECG or Respiration Cause e Poor LeadWear Disposable connection to electrode s e LeadWear Blue connector not fully inserted or defective 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 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 Copyright 2008 LifeSync Corporation LifeSync System User s Manual 50 Maintenance amp Troubleshooting Solution placement
43. has a less than fully charged smart battery installed the Battery Charging indicator will flash GREEN to indicate that the smart battery is charging It will take up to eight hours for the Monitor Transceiver to finish charging a discharged smart battery The Battery Charging indicator will glow SOLID GREEN when charging is complete Smart Battery Storage The smart battery should 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 39 of this Manual CAUTION e Store smart batteries between 40 C and 70 C 40 F and 160 F e Store smart batteries away from direct sunlight in a low humidity location with little temperature variation e Discard smart 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 or lead II Consult ECG equipment manual for more information about proper settings and operation of the respiration function Also refer to the Specifications section of this manual for details on LifeSync Wireless System respiration function Copyright 2008 LifeSync Co
44. her Monitor Transceiver Place the fully charged battery back into the Patient Transceiver 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 40 Maintenance amp Troubleshooting Smart Battery Battery Life It 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 CAUTION e Remove the plastic film cover from the battery contacts before using bic e Do not short the battery terminals Press Gon end for change status e Do not try to connect a LifeSync Smart Battery with CAUTION Risk of Fire explonion and severe any device other than a LifeSync Monitor Transceiver bumi To prevent injury ar bana d nel all e metal obgects to contact the battery termina or a LifeSync Patient Transceiver DO rot crush daasembie heat above 212 F or cheat Bes Sr ite LL qeya e Do not expose to high temperature above 60 C aos 140 F a i z amp WARNING e Do not incinerate submerge crush disassemble or autoclave the battery e Do not recharge or reuse battery that has been 0208N0001 submerged discard or recycle it immediately Battery Storage Batteries shou
45. ication Mode switch several times confirming that both indicators function Select TEMP Communication Mode Connect lead wires from the 12 lead ECG machine to the second Monitor Transceiver matching colors and lead markings Remove the V BROWN lead of 3 5 LeadWear Disposable from the Patient Simulator Remove Precordial LeadWear Disposable from package and connect electrode snaps on Precordial LeadWear Disposable to Patient Simulator including V1 RED lead Insert Precordial LeadWear connector into GREEN connector port Leave 3 5 Lead LeadWear Connector in place F Transceiver Synchronizing Temporary 12 Lead L Remove Token from the ECG machine Monitor Transceiver Confirm Insert Token Into Patient Transceiver Status indicator on this Monitor Transceiver glows SOLID YELLOW 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 Remove Token from Patient Transceiver Confirm that Return Token To Monitor Transceiver Status indicator goes OFF 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 transce
46. ifeSync System as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 MHz d 3 5 V1 VP d 3 5 E1 VP d 7 E1 VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 57 Technical Specifications Guidance and manufacturer s declaration electromagnetic immunity The LifeSync System is intended for use in the electromagnetic environment specified below The customer or the user of the LifeSync System should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic environment und guidance Electrostatic discharge ESD 6 kV contact Complies Floors should be wood con
47. it esas bi Sad Ra BAN Lau Aa 19 12 Lead Wireless MORITOFIDIB 5c e rr mc ad ded Vn ay ei o e A 21 jE lagiero eziqud dote eee PET a A AN 22 Patient Transfer Wireless to Wireless ecu i itt Da eeu rito adis 26 SustemRermowVvalcssianctvdioaoscsn tati na cu e e cured N 27 Smart BatteHes ouod dee SN seven cous Need bum an eR d tuU M UNE dU xU CDU PRU 27 Res pil NON TET E S 29 User Instructions LeadWear Disposable keke keka 30 3 5 Lead Vl OIL OTTO lse eee ean ke a a e xi E Ken Ken AW D nya DER y n Dr bau Wr esae cd AR N 30 TZ ped MORIEOLIDBL n ken kr yata eya e ete ossis ak a en aoe toes e1 n Y K Y 32 LifeSync Adapter Opera till si Lc Eylo Kan yiy nan ein Va eri e ke R S ke Kl VI Ane de E eia AE 33 User Inst etlons TAS L S yy aelali an nNa ba in Saan ac ran AU wara Ok ar n A d ote a dey ana 34 12 Lead Adapter amd 3 5 Leag AG apt er s nen xilik yak e e rae breui reat oc 34 Patient Transfer Wireless to Adapter keke ol ieu Eds MeV KA 35 Maintenance amp TroublesHoOtlDB uno y0 kanika AE pu eva PES a UE ulia E DR MUR kin 36 System Fubnctional COCK at yy el ebat ee onibus ia vade ek cated e Tu A st aint 36 Required EquipImieE yy yal comet eor deci e et vi m d w di eua brin ay ZU AD ded 36 Smart Batteries Preparaltlort sc y unen e itt RE a doces ctos pe t eU uM y n 36 Monitor Transceiver Set Up Power on Test Battery Charger ee
48. ivers flash GREEN both PERM and TEMP on the Patient Transceiver Confirm that the proper ECG signals appear on both ECG equipment displays and that the ECG signals agree with the ECG Patient Simulator settings Wait for two minutes After two minutes the ECG machine Monitor Transceiver stops receiving signals from the Patient Transceiver Confirm that the Communication Status indicator on the ECG machine Monitor Transceiver SOLID Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 39 Maintenance amp Troubleshooting YELLOW the Communication Status indicator on the cardiac Monitor Transceiver flashes GREEN and only the PERM Communication Status indicator on the Patient Transceiver flashes GREEN G Transceivers Confirm Low Battery Charge Indicators on Patient Transceiver 1 2 Disconnect Monitor Transceivers from ECG equipment and turn equipment OFF Remove the batteries from all Transceivers Disconnect the Monitor Transceivers from the Power Supply and plug to AC power 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 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 ot
49. ken from Patient Transceiver Confirm that Return Token To Monitor Transceiver Status indicator goes OFF Place Token back into Token port of the cardiac 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 PERM 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 38 Maintenance amp Troubleshooting E Monitor Transceiver Set Up Temporary 12 Lead 1 2 10 Insert Token into Token port on the top of the second Monitor Transceiver Place the third partially charged battery in the second Monitor Transceiver confirming that the plastic film contact cover has been removed 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 Connect the second Monitor Transceiver to the Power Supply and plug to AC Power Press ECG Mode switch several times confirming that both indicators function Select ECG 12 Lead mode Press Commun
50. ld 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 Storing the battery for a long period of time without use may degrade the battery capacity CAUTION e Store batteries between 40 C and 70 C 40 F and 160 F e Keep batteries in low humidity location with little temperature variation e Keep batteries away from direct sunlight Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 41 Maintenance amp Troubleshooting Adapter 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 adapter CAUTION Do not sterilize adapters by autoclave radiation or steam Always follow and retain the instructions accompanying the cle
51. maximum 38 mW MT 2 8 dBm maximum 72 mW Bluetooth Revision V1 1 CSA 22 2 No 601 1 CSA 22 2 No 601 2 27 Respiration Specifications Sensing Electrodes RA LA in Patient Transceiver Excitation Frequency 32 kHz Patient Risk Current 10 uA 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 55 Technical Specifications LifeSync System Performance with Welch Allyn Propaq Model 206 Pacer Detection and Display per EC13 2002 section 4 2 9 12 pacemaker pulses of amplitudes and durations as follows will be indicated on the display as a pacemaker pulse with a vertical dashed line e 100 200 us pulse width amplitude 3 750 mV e 200 2000 us pulse width amplitude 2 750 mV Pacemaker Pulse Rejection without Overshoot per EC13 2002 section 4 1 4 1 Pacemaker Pulse rejection without Overshoot Description HR Accuracy Pacemaker Pulses ventricular or A V sequential Propag indicates for HR all combinations with no QRS Normal Pacing ventricular or A V sequential Rejects approximately gt 95 of pacemaker pulses Ineffective Pacing ventricular or A V sequential Rejects approximately gt 95 of pacemaker pulses Pacemaker
52. n On Patient Transceiver Intermittent On Off Cause e 3 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 3 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 Copyright 2008 LifeSync Corporation LifeSync System User s Manual 44 Maintenance amp Troubleshooting 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 light on Charging indicator e Turn Monitor Transceiver On with power on off switch e User another AC outlet e Uncover and charge battery e Replace power supply e Replace Monitor Transceiver
53. nc Wireless System together with the Propaq Monitor to monitor respiration Only use the LifeSync Wireless System and LifeSync Adapter with ECG equipment that has been validated for compatibility Contact LifeSync Corporation Customer Service at 866 ECG 3888 or visit the website www LifeSyncCorp com for information on ECG Monitors that are compatible with the LifeSync Wireless System Note Validation testing for additional ECG equipment is ongoing Please contact LifeSync Corporation at 866 ECG 3888 for the current list of compatible equipment For use within the European Community only CE marked monitors EN 60601 1 compliant should be connected to the LifeSync System This will ensure compliance with EN 60601 1 1 Notes LifeSync Smart Battery LS 121 replacement 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 Adapter components that are applied to the patient are passive LifeSync LeadWear Disposables 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
54. nected to the LifeSync Power Supply and plugged to AC power and the smart battery is fully inserted and latched Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 18 LifeSync Wireless System Operation Mount the LifeSync Monitor Transceiver 1 Connect LifeSync Monitor Transceiver to LifeSync Power Supply and AC power source The Power Supply is optional if fully charged smart battery is installed in LifeSync Monitor Transceiver 2 Secure the LifeSync Mounting Plate to the desired location using the supplied double sided adhesive tape or other method NOTE The arrow on the LifeSync Mounting Plate must be pointing upward 3 Insert buttons on back of LifeSync Monitor Transceiver into slots on LifeSync 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 Token is seated in the Token port on Monitor Transceiver NOTE LifeSync Monitor Transceiver will not operate without LifeSync Token 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync
55. ns LeadWear Disposable for 3 5 Lead Monitoring on page 29 of this Manual 2 Connect Adapter to the trunk cable or monitoring equipment 3 Connect the LeadWear Disposable BLUE connector to the Adapter Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 35 LifeSync Adapter Operation Patient Transfer Wireless to Adapter To permanently transfer a patient from wireless monitoring to a wired connection 1 Connect 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 3 5 Lead or GREEN connector 12 Lead to the Adapter Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 36 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 One LifeSync Patient Transceiver LifeSync LeadWear Disposable ECG RESP 12 Lead Patie
56. nt Simulator Two LifeSync System Compatible ECG Monitors One 3 5 lead Cardiac 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 or visit the website www LifeSyncCorp com for information on ECG monitors that are compatible with the LifeSync System A Smart Batteries Preparation NOTE Smart batteries are shipped in the uncharged state with a plastic film cover covering the contacts 1 Remove the plastic film cover from the smart battery contacts 2 Leave one smart battery uncharged Charge a second smart battery to the fully charged state Partially charge a third smart battery to the point that only one LED is lit on the battery charge indicator Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 37 Maintenance amp Troubleshooting B Monitor Transceiver Set Up Power on Test Battery Charger 1 2 Insert Token into Token port on the top of the first Monitor Transceiver Place the uncharged battery in this Monitor Transceiver confirming that the plastic film contact cover has been removed Connect Monitor Transceiver to the Power Supply and plug to AC Power Press Power On Off switch Confirm that all indicators light for approximately one second an
57. onitor Transceiver or AC outlet e Monitor Transceiver is Off e Incorrect 3 5 Lead or 12 Lead ECG mode selected e Lead wire s damaged or poor connections to Monitor Transceiver e ead 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 eadWear leads incorrectly placed Copyright 2008 LifeSync Corporation LifeSync System User s Manual 49 Maintenance amp Troubleshooting Solution e Check end cap replace Patient Transceiver if damaged e Ensure battery is fully inserted 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 outlet verify green light on Charging indicator e Turn Monitor Transceiver On with power on off switch e Ensure proper 3 5 Lead or 12 Lead ECG mode selected 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 and proper connection Replace if dama
58. or Intermittent Communication synch between Transceivers 45 Patient Transcelver DeepIle 3 oeste cud tiem c kal ber k bas rek la sela r evana Nen AA 46 Monitor Transceiver DeepIlB uss ate ru ae a e A Usa eu SU wastes 46 Patient Transceiver All LEDs Intermittent On Off keke 46 Monitor Transceiver All LEDs Intermittent On Off E keke 46 Battery does not last 24 hours on Patient Transceiver or 12 hours on Monitor WEINS CO VO an rr RA 47 Monitor Transceiver not charging battery or Monitor Transceiver battery charge Igreiiszirelniare drm 47 V Lead Off for 3 5 Eead only u iy lisak nal ren keda k n k bik qood N y Ena N aS Ha KA Mi Ha RAW en 47 NG ECG OF Leads Off PN DO a Hd Car Eod owed Pets AN 47 Inverted signal on ECG equipment sosise rieri aA A aaa 48 Intermittent ECG Artifact and NOS Cv iecore eio tut bebe tr doe A Ei a Ebor Ponte td been 48 No Intermittent or Noise Respiration k l eese eene enne nnn nennen 49 Adapter No ECG Or RespIFatlOl i cy cepa at due qu tiet i eyan a San AA Aa SC 50 Adapter Intermittent Noisy ECG or Respiration keke 51 Technical SDSCIIICdEIOLIS us dupevtin Coh eost dint wa h A 44 SPECI ON aca N ee ene ere oR ence eu I Ue rd gde 44 Manutacturer s INTORMAU OM ci s ie keyan a aed HEK er n Kekan ue 61 Reorder lil ola HO ca eode en ton du ue kS aec e Kes ett
59. outlet e Replace Monitor Transceiver e Switch to 3 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 LS 164 Rev 7 08 Symptom No ECG or Leads Off Continued Inverted signal on ECG equipment Intermittent ECG Artifact and Noise Cause e Power supply not connected to Monitor Transceiver or AC outlet e Monitor Transceiver is Off e Incorrect 3 5 Lead or 12 Lead ECG mode selected e ead wire s damaged or poor connections to Monitor 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 Transceiver failure e Incorrect lead wire connections to Monitor Transceiver e eadWear leads incorrectly placed e Electrode s faulty not properly placed or skin not properly prepped e Poor LeadWear Disposable connection to electrode s e eadWear connectors not fully inserted or defective curling scratches etc e eadWear
60. pable the respiration signal will also appear Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 21 LifeSync Wireless System Operation 12 Lead Wireless Monitoring To continuously monitor 12 lead ECG signals using a 12 lead cardiac monitor Select LifeSync Monitor Transceiver Settings NOTE Make sure a LifeSync Token is installed in the token port of the Monitor Transceiver 1 Press Power On Off switch to turn Monitor Transceiver ON 2 Press ECG Mode switch until the indicator 12 LEAD glows GREEN 3 Press Communication Mode switch until the indicator PERM glows GREEN Apply LifeSync LeadWear Disposable 1 Select appropriate size 3 5 Lead LeadWear Disposable BLUE connector for the patient refer to size chart on page 9 and appropriate size 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 31 of this Manual 2 Pull the flexible cap away from GREEN connector port and insert both 3 5 Lead and precordial LeadWear Connectors into BLUE and GREEN slots on Patient Transceiver matching colors Inserting the Lead LeadWear BLUE Connector will turn the Patient Transceiver ON Ensure that connectors are seated securely and that tabs lock into place 3 Place Patient Transceiver inside Pouch or Armband and seal the top of th
61. poration LS 164 Rev 7 08 LifeSync System User s Manual 13 Introduction to the LifeSync Wireless System Power On Off switch ON OFF Switch Press to turn unit ON or OFF GREEN SOLID Battery is fully charged GREEN FLASHING Battery is charging Battery Charging NOTE The GREEN light is only active when the unit is connected to the LifeSync Power Supply plugged into AC power YELLOW FLASHING with a periodic BEEP NOTE The YELLOW light is only active when the unit is NOT Battery charge level low less than 60 minutes operation time left Low Battery Charge connected to the LifeSync Power Supply plugged into AC power Service RESEN KE Transceiver malfunction FLASHING Press switch to alternate between ECG modes ECG Mode Indicates whether LifeSync GREEN SOLID Wireless System is in 3 5 LEAD or 12 LEAD mode Press switch to alternate between communication modes Indicates whether LifeSync GREEN SOLID Wireless System is in Temporary TEMP or Permanent PERM mode Communication Mode Smart Battery The LifeSync Smart Battery is a 3 6 Volt rechargeable Lithium ion battery with a built in fuel gauge and is interchangeable between the LifeSync Patient Transceiver and the LifeSync Monitor Transceiver Batteries are shipped in the uncharged state The LifeSync Smart Battery charges in less than eight hours when installed in a LifeSync Monitor Transceiver that is connected to the LifeSyn
62. r 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 DC Offset any channel 5 mV maximum Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync 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 between 2 and 700mV of duration 0 1 2 0 ms per ANSI AAMI EC13 2002 Pacer Pulse Function Trigger Slew Rate Pacer Pulse functions triggers when ECG signal slew rate exceeds 10 000 n Signallatencyduetoradio Latency Signallatencyduetoradio to radio 500 ms maximum ms maximum Operating Battery 3 6 VDC po Capacity 2200 mA hr po Technology Rechargeable Lithium lon Operating Battery Life Patient Transceiver W xHxT W xHxT Atmospheric Pressure 700 1060 mbar Housing Material Radio Protocol Bluetooth wireless technology Class Class 2 Range 10 m Operating Frequency 2 402 2 480 GHz Channels 79 1MHz channels Power output level PT 8 3 dBm
63. ransceiver in a designated storage location 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 Smart 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 smart battery in the Patient Transceiver runs low it can quickly be exchanged for a fully charged smart battery in the Monitor Transceiver NOTE Each Transceiver has 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 Charge Level Indicator Each Smart Battery has a built in charging gauge Press the oval on the end of the gauge to view the charge indicator Each LED represents 2096 of battery capacity 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 capacity is more than one year old it is recommended that the battery be replaced Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual LifeSync Wireless System Operation Exchanging Smart Batteries Remove the smart battery from the Transceivers by rel
64. rporation LS 164 Rev 7 08 LifeSync System User s Manual 30 LifeSync Wireless System Operation User Instructions LeadWear Disposable 3 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 NOT pull snaps out of holes by tugging on the LeadWear Disposable itself 2 Attach recommended electrode s 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 3 5 Lead LeadWear Disposable Electrode Placement LL Red Left side of chest below navel Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 31 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 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 32 LifeSync Wireless System Operation 12 Lead Monitoring 1 Remove
65. s 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 Adapters Clean the 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 adapters to dry completely after cleaning Disinfect the adapters by using a chemical disinfectant such as ethanol propanol or glutaraldehyde Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 43 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 2008 LifeSync Corporation LS 164 Rev 7 08 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 tur
66. s directly connected to wireless telemetry transmitters NOTE LifeSync Adapters are non sterile reusable and latex free Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 LifeSync System User s Manual 17 LifeSync Wireless System Operation LifeSync Wireless System Operation The LifeSync Wireless System works with existing ECG monitor equipment and with recommended electrode s 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 35 of this Manual Wireless System Set Up Install Check Smart 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 Swing battery clips to the side off the end of the battery Remove battery from each transceiver 2 Check battery charge indicator on each battery by pressing the oval If all five battery indicators are not lit replace battery with a fully charged battery Each LED represents 2096 of battery life 3 Re install battery into each transceiver and secure by latching battery clips back over the end of the battery NOTE Use a fully charged battery To charge the LifeSync Smart Battery ensure the LifeSync Monitor Transceiver is con
67. sceivers 1 Remove token from Monitor Transceiver The Insert Token Into Patient Transceiver indicator on the Monitor Transceiver will glow SOLID YELLOW 2 Pull the flexible cap away from the token port on Patient Transceiver and fully insert token into token port Wait for the Return Token Into Monitor Transceiver indicator on the Patient Transceiver to glow FLASHING YELLOW The Patient Transceiver will also produce a single audible BEEP when the Token is properly seated 3 Remove token from Patient Transceiver and close flexible cap over token port the Return Token Into Monitor Transceiver indicator on the Patient Transceiver will go off 4 Fully insert the token into the token port on the Monitor Transceiver The Monitor Transceiver will BEEP when the token is properly re inserted and the Insert Token Into Patient Transceiver indicator will go off 5 Within a few seconds the Transceivers Communication Status indicators will display FLASHING GREEN if communicating or SOLID YELLOW if communication failed If communication fails repeat steps 1 thru 5 Patient Transceiver PERM Communication Status indicator will flash GREEN Communication in process with Monitor Transceiver Monitor Transceiver Communication Status indicator will flash GREEN Communication in process with Patient Transceiver The patient s ECG signal will appear on the cardiac monitor within a few seconds If ECG cardiac monitor is respiration ca
68. 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 a minimum amplitude of patient physiological signal may cause inaccurate results Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 6 LifeSync System User s Manual Introduction to the LifeSync Wireless System Introduction to the LifeSync Wireless System System Overview The LifeSync Wireless System is designed 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 recommended electrode s The trunk cable function is replaced by a pair of two way radios the LifeSync Patient Transceiver and the LifeSync 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
69. st 24 hours on Patient Transceiver or 12 hours on Monitor Transceiver Monitor Transceiver not charging battery or Monitor Transceiver battery charge indicator not lit V Lead Off for 3 5 Lead only No ECG or Leads Off Cause e Monitor Transceiver failure e Battery not fully charged at start when replaced e Battery at end of life or faulty 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 eadWear connectors not fully inserted or defective curling scratches etc e eadWear damaged e End cap damaged e Patient Transceiver battery is discharged or defective Copyright 2008 LifeSync Corporation LifeSync System User s Manual 47 Maintenance amp Troubleshooting Solution e Replace Monitor Transceiver e Ensure battery is fully charged at installation e Replace battery e Connect power supply to Monitor Transceiver and AC outlet verify green light on Charging indicator e Ensure battery is fully inserted and latched e Uncover and charge battery e Replace battery e Replace power supply e User another AC
70. to the correct monitor The LifeSync Patient Transceiver is powered by the LifeSync Smart Battery The LifeSync Monitor Transceiver can also be powered by a LifeSync Smart 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 use LifeSync Patient Transceiver Pouch to protect it from contamination by foreign debris A LifeSync Armband is also available to hold the LifeSync Patient Transceiver in place on the patient s arm In areas where the wireless capability of the LifeSync Wireless System is not in use LifeSync Adapters are available to connect the LeadWear Disposable s directly to an ECG monitor Copyright 2008 LifeSync Corporation LS 164 Rev 7 08 7 LifeSync System User s Manual Introduction to the LifeSync Wireless System Unpacking Checklist Patient Transceiver n DI LifeSync Smart Battery Ll User s Manual CD Monitor Transceiver n O O 1 O 1 LeadWear Disposable DI LifeSync 3 5 Lead LeadWear Disposable 1 O A printed LifeSync System User s Manual is provided with each f

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