ReadyLink Operating Instructions ( PDF )
Contents
1. The ReadyLink 12 Lead ECG 1s intended to be a high performance multi channel multifunctional electrocardiograph As a resting electrocardiograph ReadyLink simultaneously acquires data from multiple channels Once the data 15 acquired it can be reviewed stored transmitted and or printed It will be a device primarily intended for use in hospitals but may be used in mobile environments including pre hospital emergency medical services ambulance and patient transport medical clinics and offices of any size Indications for Use The device is indicated for use to acquire analyze display transmit print record and store electrocardiograms e The device is indicated for use to provide interpretation of the data for consideration by a physician The device is indicated for use a clinical setting or mobile environments including pre hospital emergency medical services ambulance and patient transport by a physician or by trained personnel who are acting on the orders of a licensed physician It is not intended as a sole means of diagnosis e The interpretations of ECG offered by the device are only significant when used In conjunction with a physician over read as well as consideration of all other relevant patient data e The device is indicated for use on adult and pediatric populations e The device is not intended to be used as a vital signs physiological monitor SECTION 1 System Description ReadyLin2. 21 0 111 Aie a MN 21 Accessing uu u uuu ee ne OTT TOTO 21 Abbreviated Configuration Settings aaa 22 TROUBLESHOOTING AND MAINTENANCE APPENDIX A 23 Capunne 23 L l yo u 23 lis Vy Ll u 23 E M i lt lt me 29 EV OI 24 Recommendations to Biomedical A 24 l I 24 Calibration or the Ready Link uuu uu i s 24 XX INTRODUCTION SECTION 1 Manual Purpose This manual is intended to provide the user with Information about e Using and understanding the ReadyLink 12 Lead ECG electrocardiograph the function and feature keys and the display screen Preparing the ReadyLink for use Section 2 Acquiring viewing and storing an ECG Section 3 Connectivity and transmitting ECGs Section 4 Maintaining the ECG Archive Section 5 System settings Section 6 Maintenance and troubleshooting Appendix A Audience This manual is written for clinical professionals They are expected to have working knowledge of medical procedures and terminology as required for monitoring cardiac patients Intended Use
3. If the device must be used adjacent to or stacked on top of other equipment verify that the device operates in an acceptable manner in the configuration in which it will be used Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment See Table X 4 for recommended separation distances between the radio equipment and the device The use of accessories transducers and cables other than those specified by Mortara Instrument may result increased emissions or decreased immunity of the equipment XV ELECTROMAGNETIC COMPATIBILITY EMC Table X 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The equipment is intended for use the electromagnetic environment specified in the table below The customer or the user of the equipment should ensure that it is used in such an environment Emissions Test Compliance Group 1 The equipment uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment Class A The equipment is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for Electromagnetic Environment Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000 3 2 domestic purposes Table X 2 Guidance a
4. ces oc sce oe wets Ee MAD 4 Figure 1 3 Display Overview 8 Lead Real Time ECG 5 Ili IO P us canes 6 l i T a a E E A E A au AE T A u E jorge Torn NER ASS T E E T T sss 8 EQUIPMENT PREPARATION SECTION 2 Chare tie Car LIL uuu a ua ene ee CE Ce 9 O On AL IL G uuu na EET 10 SG in Tomi ae EDS uuu u u uuu unus MM 11 RECORD AN ECG SECTION 3 ili mE PEE 021 an ae S 13 Li ill u 13 Patient Hookup Summary Table anna nans 14 gt RETE 15 POG Acquisition 16 Wille ema 15 i l uu v c 15 bac gn Sse css gerne 16 VERTS BEREIT DTE 16 CONNECTIVITY AND ECG TRANSMISSION SECTION 4 PCO THO iu 17 GSM GPRS Mobile Transmission 0 0 00 00000 0000000 18 ECG ARCHIVE SECTION 5 we P 19 Sample Test Report 19 XIX TABLE OF CONTENTS SYSTEM SETTINGS SECTION 6 TCC Wii ip S Op
5. e Rub skin vigorously with a pad such as a 2 x 2 or 4 x 4 gauze to remove dead skin cells and oil and to increase capillary blood flow e Follow any other instructions provided with the electrodes NOTE With elderly or frail patients take care to not abrade the skin causing discomfort or bruising Clinical discretion should always be used in patient preparation Patient Hookup Correct electrode placement is important for acquiring a successful ECG A good minimum impedance pathway will provide superior noise free waveforms Good quality silver silver chloride Ag AgCl electrodes should be used TIP Electrodes should be stored in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity To Attach the Electrodes Expose the arms and legs of the patient to attach the limb leads Place the electrodes on flat fleshy parts of the arms and legs If a limb site is not available place the electrodes on a perfused area of the stump Attach the electrodes to the skin A good test for firm electrode contact is to slightly tug on the electrode to check adhesion If the electrode moves freely it needs to be changed If the electrode does not move easily a good connection has been obtained Due 13 SECTION 3 For accurate V lead placement and monitoring it is important to locate the 4 intercostal space The 4 intercostal space is determined by first locating the 1
6. MATERIALS OR ANY PRODUCT S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period Mortara s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product s 1 of all carrier charges with respect to any Product s returned to Mortara s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara and 11 all risk of loss in transit It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer A purchaser of a Product s by its acceptance and purchase thereof acknowledges and agrees that Mortara is not liable for loss harm or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product s If Mortara should be found liable to anyone under any theory except the expressed warranty set forth herein for loss harm or damage the liability of Mortara shall be limited to the lesser of the actual loss harm or damage or the original purchase price of the Product s when sold EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER BATTERIES ELECTRODES PATIENT CABLES LEAD WIRES AND MAGNETIC STORAGE MEDIUMS EXCEPT AS SET FORTH HEREIN WITH RESPECT TO RE
7. and the head and body of the user and any nearby persons at all times RF exposure to wrists and hands within the 20 cm distance while operating the device in the normal handheld position is not subject to the same distance restriction and is believed to be safe To help prevent degradation of RF signal and to avoid excess RF energy absorption do not touch the antenna during data transmission e The GSM GPRS and WLAN modules comply with applicable RF safety standards including standards and recommendations for the protection of public exposure to RF electromagnetic energy that have been established by governmental bodies and other qualified organizations such as the following e Federal Communications Commission FCC Directives of the European Community e Directorate General V in Matters of Radio Frequency Electromagnetic Energy AN Caution s e To prevent possible damage to the keyboard do not use sharp or hard objects to depress keys only use fingertips not attempt to clean the device or patient cables by submersing into a liquid autoclaving or steam cleaning as this may damage equipment or reduce its usable life Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth Use of unspecified cleaning disinfecting agents failure to follow recommended procedures or contact with unspecified materials could result in increased risk of harm to users patients and bystanders or damage to
8. carry case The device should be kept within the carry case for use Charging the ReadyLink Plug the ReadyLink power cord into the bottom of the cradle and then connect the AC DC converter cord to the power source The power indicator on the cradle will illuminate when the device is securely placed into the cradle and there is an AC DC power connection Turn the device on and look at the display screen for an indicator that states DOCKED AC This indicates the device is seated correctly and 15 charging If the device is not seated correctly Attention ReadyLink not properly docked will appear If this happens remove the ReadyLink and cradle from the case and gently push the device into the cradle to ensure it 1s properly seated If the device states DOCKED vs DOCKED AC verify the green power indicator on the cradle is illuminated To remove the ReadyLink from the cradle pull the locking tab on the back of the cradle Battery Power The battery power indicator is displayed in the lower right corner of the screen When remaining charge is very low BATT LOW will be displayed instead To view the exact battery charge level select Opt from the real time ECG view When the battery charge is below 20 transmission of ECG records by GSM GPRS mobile is not possible When the battery charge 15 depleted to its lowest level the device will automatically power down Connect the ReadyLink to its power supply to transmit ECG data and
9. last time the transmission fails a transmission fail message will display and the ReadyLink will beep three times Move to a location with a clearer or stronger signal and attempt to transmit again GPRS Global System for Mobile communications is a world standard for digital cellular communications using narrowband TDMA Time Division Multiple Access Similar to GSM cellular phones the ReadyLink GPRS mobile connectivity option requires a Subscriber Identity Module SIM smart card The ReadyLink ships with a preinstalled SIM card 18 ECG ARCHIVE SECTION 5 Archives The standard ECG Archives saves up to 60 ECGs depending on the storage space required for individual records Management of ECG records is performed within the Archives Records in the Archives will be listed by patient name patient ID or record ID depending on the populated demographic information and are listed in order of creation with the most recent record on top From the Options menu use the keyboard to select 1 and display the ECG Archive Use A to navigate by line upward use Y to navigate by line downward Highlight a record to view the demographic data Use Selec to access all reports within the highlighted record or to transmit old reports via the same process as for an active record To delete an ECG record highlight the desired record and select Delet A display message will ask Are You Sure Select Yes or No Records for which all reports have bee
10. the device Vil USER SAFETY INFORMATION e No user serviceable parts inside Screw removal by qualified service personnel only except for Installation of SIM card Damaged or suspected inoperative equipment must be immediately removed from use and must be checked repaired by qualified service personnel prior to continued use The rechargeable internal battery 1s a sealed lithium ion type and it is totally maintenance free If the battery appears to become defective refer to Physio Control technical support e Do not pull or stretch patient cables as this could result in mechanical and or electrical failures Patient cables should be stored after forming them into a loose loop Note s e Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device e Proper patient preparation 15 important to proper application of ECG electrodes and operation of the device e There is no known safety hazard if other equipment such as pacemakers or other stimulators is used simultaneously with the device however disturbance to the signal may occur If an electrode is not connected properly to the patient or one or more of the patient cable lead wires are damaged the display will indicate a lead fault for the lead s where the condition is present e Operation of the ReadyLink with an AC Mains power source connected to the PWR power receptacle on the cradle may
11. 5 calibrated at the factory No user adjustment or periodic recalibration is required 24
12. Feature keys are used as a one touch operation for ECG ACQUISITION START INITIATE TRANSMISSION CANCEL TRANSMISSION I SECTION 1 Specifications FEATURE SPECIFICATIONS Instrument Type 12 lead electrocardiograph Input Channels Simultaneous acquisition of all 12 leads Standard Leads Acquired l IL lll aVR aVF V1 V2 V3 V4 V5 V6 Backlit 1 4 VGA LCD 320 x 240 VAVE Iona S pia 3 lead groups 8 or 12 lead presentation Input Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection Patient Leakage Current Meets or exceeds the requirements of ANSI AAMI ES Chassis Leakage Current Digital Sampling Rate 10 000 s sec channel used for pacemaker spike detection 1000 s sec channel used for recording and analysis Gain Setting 5 or 10 mm mV Keyboard Type Elastomer keyboard with complete alphanumeric keys soft key menu and dedicated function keys Frequency Response 0 05 to 300 Hz High performance baseline filter AC interference filter 50 60 Hz low pass filters 40 Hz 150 Hz or 300 Hz 6 72 x 5 32 x 1 50 17 2 x 13 5 x 3 8 cm without cradle or carry case External AC DC converter 100 240 VAC at 50 60 Hz 15 VA internally Power Requirements rechargeable battery Contact your sales representative for more information Meets or exceeds the requirements of ANSI AAMI 11 Filters EQUIPMENT PREPARATION SECTION 2 The ReadyLink ships pre assembled within its
13. IMBURSEMENT OF LABOR CHARGES A PURCHASER S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD IN NO EVENT INCLUDING THE CLAIM FOR NEGLIGENCE SHALL MORTARA BE LIABLE FOR INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES OR FOR ANY OTHER LOSS DAMAGE OR EXPENSE OF ANY KIND INCLUDING LOSS OF PROFITS WHETHER UNDER TORT NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW OR OTHERWISE THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE iii IV WARRANTY INFORMATION USER SAFETY INFORMATION AN Warning Means there is the possibility of personal injury to you or others AN Caution Means there 16 the possibility of damage to the device Note Provides information to further assist in the use of the device Warning s This manual gives important Information about the use and safety of this device Deviating from operating procedures misuse or misapplication of the device or ignoring specifications and recommendations could result in increased risk of harm to users patients and bystanders or damage to the device e To maintain operator and patient safety w
14. PHYSIO CONTROL ReadyLink 12 LEAD ECG Uperating Instructions Manufactured by Mortara Instrument Inc Milwaukee Wisconsin U S A CAUTION Federal law restricts this device to sale by or on the order of a physician 0459 REF 9515 170 70 ENG Rev C1 Mortara 2011 Mortara Instrument Inc All rights reserved This document contains confidential information that belongs to Mortara Instrument Inc and Physio Control Inc No part of this document may be transmitted veproduced used or disclosed outside of the receiving organization without the express written consent of Mortara Instrument Inc Physio Control Inc ReadyLink ELI and VERITAS are registered trademarks Cisco is the registered trademark of Cisco Systems Inc DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information V1 13 TECHNICAL SUPPORT AND SERVICE Headquarters Technical Support Physio Control Inc Physio Control Inc 11811 Willows Road NE 11811 Willows Road NE Redmond WA 98052 Redmond WA 98052 www physio control com Tel 800 732 3081 Tel 800 442 1142 Email smartdesk medtronic com Fax 800 426 8049 NOTICES Manufacturer Mortara Instrument Inc 7865 N 86th Street Milwaukee Wisconsin 53224 European Union Representative Mortara Rangoni Europe Srl Via Cimarosa 103 105 40033 Casalecchio di Reno BO Ita
15. R STIT ABNORMALITY IN WaVF PROBABLY OLD WITH POSTERIOR EXTENSION PROMINENT R WAVE IN V1 V7 ABNORMAL ECG UNCONFIRMED REPORT 22 2 I l l ee VV VV VV l du MAN NIU W mmimV 0 05 150Hz 25mmis RL12Lead 1 13 1 110350058134 SYSTEM SETTINGS SECTION 6 Setting Technician Password From real time ECG view select Opt Using the keyboard select 4 Configuration from the Options menu Using the keyboard enter the technician password default 0000 no quotation marks While holding down ft SHIFT depress ALT and P simultaneously Using the keyboard enter the admin password default 0000 no quotation marks This will automatically advance you to the set passwords display Enter a technician password followed by a second entry to confirm Leaving the technician password blank will disable password protection for any screen protected by the technician password Select Back to return to real time ECG view To update the passwords after already changing the admin and technician passwords from the default values the currently active passwords must be used in place of 0000 above NOTE Password is case sensitive and alphanumeric Site Configuration The site configuration 15 used to determine how data 15 routed through the LIFENET System The site name entered here must match the site name entered in the LIFENET System ot ELK CE E Select Opt from
16. Test transmission described in Section 1 and each time a report is transmitted to LIFENET To make changes manually type in the desired date and time values using a 24 hour clock in the same format as displayed Use A and Y to move back and forth through each row TIP Use the backspace key BKSP to erase entry errors Select Save to save changes before exiting Any changes made to time or date will be lost if not saved prior to exiting Select Opt to return to the Options menu Select 2 Set Time Date to return to the Set Time Date menu Press More to enter the Clock Configuration menu Enter the Date Format Enter Clock Mode Clock mode options are Real Time default or Elapsed Time from the start of an active record DST Daylight Savings Time For the Time Sync function to properly sync to local time DST must be set to ON at the beginning of daylight savings spring and set to OFF at the end of daylight savings fall This can be done automatically by selecting AUTO Press Page to enter the Daylight Savings Configuration menu if DST Auto has been selected Enter the appropriate daylight savings start date and time and the appropriate daylight savings end date and time Press Page to return to the Clock Configuration screen Time Zone TIP Use the gt arrows to move back and forth throughout the selections Select Opt to return to the Options menu Data will automatically be saved Year Mo
17. all reports acquired in the record if no other demographic information is entered Patient demographic information can be entered before acquisition The entered patient ID fields will remain populated until you acquire the ECG however if you disconnect the leads from the patient turn off the electrocardiograph change a configuration setting or enter the ECG Archive the patient information will be cleared To access the patient demographic data entry menu press P ID from real time ECG view Use Enter 5 Tab A or Y to move to each data entry field Skipped fields will appear as a blank field on the header of the ECG The date of birth and age fields will be prefilled with the default values of a 40 year old male used by the Interpretation algorithm TIP Type F from the keyboard to change the gender to female type M to change the gender to male Prompt if Empty P ID If an ECG is acquired without previously populating any demographic fields or if P ID on empty demo is enabled in the Configuration menu the demographic data entry screen will automatically open to request entry of patient demographic information before transmission ECG Acquisition Viewing Storage Acquisition Once the patient is connected the ReadyLink continuously collects and displays ECG data therefore before you press 12 LEAD you should instruct the patient to relax in a supine position to ensure that the ECG is free from artifact noise due to pati
18. aveform 1s available the acquired ECG view The first 5 seconds are shown on the initial view screen page 1 2 is displayed the upper right corner the second 5 seconds is viewed by selecting Page page 2 2 is displayed in the upper right corner You can move through the available 10 seconds of acquired ECG waveforms for each lead by using Leads and Page HR 60 25mm s 10mm uV Som P D SINUS RHYTHM POSSIBLE RIGHT ATRIAL ENLARGEMENT 0 25MV P WAVE BORDERLINE ECG UNCONFIRMED REPORT RM 12 LEAD 10 second preview assists in ensuring a quality ECG acquisition prior to transmitting the relationship between the display and the transmitted data 15 the same what 15 displayed in the ECG acquisition view is what will be transmitted To view the interpretation of the acquired ECG select Intrp Select Meas to view the measurements To return to the real time ECG view without transmitting the ECG select Home The device will require confirmation before proceeding The ECG waveform interpretation statements and measurements for that report can be accessed any time during the active patient record through the transmit report screen To reach the transmit report screen from the Home screen press the XMT button and then the Rpt softkey Highlight the desired report and press the View softkey to access the ECG waveform interpretation statements and measurements Save Storage ECGs are automatically saved to the Archives
19. aximum capacity of either 60 or 150 ECGs has not been exceeded Memory full ECG not saved Ensure maximum capacity of either 60 or 150 ECGs has not been exceeded Failed to change record status Contact customer service Failed to read record Contact customer service Capturing ECG Errors LCD MESSAGE RESOLUTION ECG Error Gross artifact Re prep and acquire new ECG Battery Errors LCD MESSAGE RESOLUTION PLEASE CONTACT Contact customer service CUSTOMER SERVICE d u Battery Error Contact customer service Password Errors LCD MESSAGE RESOLUTION Compare Ensure correct password entry in both locations 2 Password Compare Ensure correct password entry in both locations oro Administrative password is required technician password may be empty General Errors LCD MESSAGE RESOLUTION Not Properly Docked pressure to top of electrocardiograph ensuring proper seat in READYLINK NOT Apply slight pressure to top of electrocardiograph ensuring a proper seat in PROPERLY DOCKED the cradle Battery Too Low for Operation to cradle and allow to charge for a minimum of 23 APPENDIX A Test Operation After cleaning and inspecting the ReadyLink proper operation of the unit may be confirmed by using an ECG simulator to acquire and view a standard 12 lead ECG of known amplitude Waveforms should appear normal with proper amplitude and without distortion or excessive noise A test transmi
20. bility of serious injury or death during patient defibrillation do not come into contact with device or patient cables Additionally proper placement of defibrillator paddles relation to the electrodes 15 required to minimize harm to the patient This device was designed to use the electrodes specified in this manual Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation inflammation or other adverse reactions Electrodes are intended for short term use and should be removed from the patient promptly following testing To avoid potential for spread of disease or infection single use disposable components e g electrodes must not be reused To maintain safety and effectiveness electrodes must not be used beyond their expiration date To ensure the safety of both the patient and the device 1 5 meters 5 of open area should surround the patient No peripheral equipment may be connected to the device when within this patient area A possible explosion hazard exists Do not use the device in the presence of a flammable anesthetic mixture There is a potential pinch hazard when inserting the device into its docking station and or cradle that could result in minor injury Care should be taken to avoid entrapment of fingers when performing this operation To improve immunity to potential interfering electromagnetic signals shielded cabling is recommended when conne
21. c field 30 characters Battery Time Out 5 min 10 min 20 min 30 min Prompt if Empty P ID Yes Software Version Identifies the software version of your electrocardiograph Device ID Defines your device name Enter up to 30 alphanumeric characters The Device ID prints on the bottom edge of the ECG printout Battery Time Out Determines when the electrocardiograph will switch off in order to conserve the battery life of the device The battery time out will only occur if the keyboard has not been depressed for the time specified The battery time out setting is ignored if an active ECG signal is detected during transmission Volume Defines the keyboard click loudness Available settings range from 0 off to 8 loud Prompt if Empty P ID Allows or prevents automatic opening of the demographic screen when an ECG 15 acquired without previously entered patient demographics Auto send ECG Defines whether a newly acquired ECG 1s automatically transmitted to the default site Allow GPRS Roaming Allows user to turn off roaming forcing the ReadyLink to lock exclusively on the SIM card provider in order to avoid locking on networks during roaming and not be able to transmit when necessary GPRS Retries Defines the number of time the ReadyLink will automatically retry if a GRPS transmission has failed 22 TROUBLESHOOTING AND MAINTENANCE APPENDIX A ECG Record Errors LCD MESSAGE RESOLUTION Unable to save ECG Ensure m
22. ce is equipped with such a module If so equipped the following notices apply e The GSM GPRS module operates in allocated frequency bands depending on the model Identification of the installed GSM GPRS module can be found on a label on the bottom of the device e MultiTech Systems Inc Model MTSMC G F1 Europe and elsewhere 900 1800 MHz e MultiTech Systems Inc Model MTSMC G F2 U S and elsewhere 850 1900 MHz e MultiTech Systems Inc Model MTSMC G F4 Quad Band 900 1800 or 850 1900 MHz user selectable e The WLAN identification can be found on a label on the bottom of the device e Quatech Inc Model WLNG AN DP101 2400 MHz e Use of the GSM GPRS or WLAN module may interfere with other equipment operating in the vicinity Check with local authorities or spectrum management officials in your facility to determine if restrictions apply to the use of this feature in your area e Donottransmit via the GSM GPRS or WLAN module with a missing or damaged antenna Replace a damaged antenna immediately e Use only the antenna supplied for use with this device Unauthorized antennas modifications or attachments could damage the transmitter module and may contravene local RF emission regulations or invalidate type approval e To ensure compliance with current regulations limiting both maximum RF output power and human exposure to radio frequency radiation a separation distance of at least 20 cm must be maintained between the device s antenna
23. cord by pressing P ID key or use Selec to review the record ID site name and report date and time prior to transmission If more than one ECG has been acquired on this patient select Rpt to advance to the next menu Use A to navigate by line upward through the individual records use Y to move by line downward through the individual records Select one several or ALL ECGs associated with this patient Use Site to select the desired destination site To transmit the selected record s press Send Transmission Status Transmission Complete Press any Key to Continue 1 1 ECG s Transmitted Initial Signal Strength d Y AT amp T Registered Home Network M 12 LEAD A successful transmission will be marked by one audible beep A failed transmission will be marked by three audible beeps After transmission press any key to return to the previous screen SECTION 4 GSM GPRS Miobile Transmission NOTE The ReadyLink displays a signal strength indicator antenna symbol and bars as well as the network currently used by the GSM module CAUTION GSM GPRS mobile hookup time will vary depending on location It may require between 5 and 60 seconds to initiate a communication link Signal loss at the onset of transmission or during transmission may occur due to environmental variables NOTE In the event of a poor RF signal the ReadyLink can retry transmitting 0 3 10 or unlimited number of times see System Settings At the
24. cting the device to a network To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment network cable shielding where used must be connected to protective earth ground appropriate to the area where the device 15 used The device has not been designed for use with high frequency HF surgical equipment and does not provide a protective means against hazards to the patient The quality of the signal produced by the device may be adversely affected by the use of other medical equipment including but not limited to defibrillators and ultrasound machines For proper operation and the safety of users or patients and bystanders equipment and accessories must be connected only as described in this manual Do not connect a telephone line cable to the LAN connector This device was designed for handheld or tabletop use Only slight pressure is required to operate keys on the keyboard To help avoid possible fatigue and related stress injuries do not exert excessive force when pushing keys or continuously operate the device using the same finger and hand motions for long periods of time USER SAFETY INFORMATION e Some Mortara electrocardiographs can be equipped with a GSM GPRS cellular modem or wireless LAN WLAN module for transmitting ECG records Device labeling and the presence of an antenna port will indicate if your devi
25. diation CAUTION POSSIBLE EQUIPMENT DAMAGE Do not clean the patient cables with bleach bleach dilution or phenolic compounds Do not use abrasive or flammable cleaning agents Cleaning the Device Disconnect the power source Clean the exterior surface of the device with a damp soft lint free cloth using a solution of mild detergent diluted in water After washing thoroughly dry off the device with a clean soft cloth or paper towel Use caution with excess liquid as contact with metal parts may cause corrosion Do not use excessive drying techniques such as forced heat Sterilization Sterilization Is not recommended for cables and lead wires Cautions Improper cleaning products and processes can damage the device produce brittle lead wires and cables corrode the metal and void the warranty Use care and proper procedure whenever cleaning or maintaining the device xili XIV GENERAL CARE ELECTROMAGNETIC COMPATIBILITY EMC Electromagnetic compatibility with surrounding devices should be assessed when using the device An electronic device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC has been performed on the device according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 The device should not be used adjacent to or stacked on top of other equipment
26. ent activity If workflow permits patient demographic entry prior to acquisition connect the patient to the ReadyLink and enter the patient identification information as explained in Patient Demographic Entry After you complete the last data entry field select Home to return to the real time ECG view Examine the display for artifact or baseline drift Re prep and replace electrodes if necessary to obtain satisfactory waveforms See Patient Preparation If a lead fault occurs square waves appear on the display for that lead and the lead s in fault will display in the upper left corner of the screen one at a time When the problem is corrected the device waits for 10 seconds of good data before analyzing the ECG 15 SECTION 3 Please refer to the following troubleshooting guide based on Einthoven s Triangle Artifact Check Electrode Lead II and III artifact Poor LL electrode or left leg tremor Lead and II artifact Poor RA electrode or right arm tremor Lead and III artifact Poor LA electrode or left arm tremor V Leads Re prep site amp replace electrode LL NOTE LCD label functions are not available during acquisition Press 12 LEAD The real time ECG view is then replaced with the acquired ECG view The default real time ECG view 1s not available in the acquired ECG view for navigation purposes NOTE New LCD label functions are available in the acquired ECG view Viewing A preview of the full 10 seconds of ECG w
27. f the display screen NOTE lead fault occurs the lead name flashes this location until fault is corrected In the event all leads are disconnected LEADS OFF will flash until the fault is corrected Speed Speed in millimeters per second 15 displayed in the top center portion of the display screen to the right of HR The default speed for rhythm viewing is 25 mm s Gain Gain is displayed in the top center portion of the display screen to the right of speed The waveform amplitude for display is 5 or 10 mm mV depending on the displayed leads SECTION 1 Filter Filter is displayed in the top center portion of the display screen to the right of Gain The default filter setting Is 150 Hz Battery Battery charge availability displays in increments of 25 the bottom right hand corner When charging in its docking station or in its cradle and connected to the battery charger the device s battery gauge will be replaced with a flashing charging symbol indicating the device is charging Once fully charged the battery gauge displays at 100 Clock Time display with hour minutes and seconds resolution See Section 2 for setting a new time DOCKED AC DOCKED AC is continuously displayed when the ReadyLink is properly docked in the cradle and is connected to the battery charger This message disappears once the ReadyLink is removed from the cradle If the device is not properly docked Attention Read
28. has tested the coexistence of the device with other devices that can interfere such as devices using WLAN Bluetooth radio and or cell phones Although the current technology allows a very successful rate of transmission it s possible that in some rare occurrences the system may not perform at its best resulting a failed transmission When this occurs patient data will not be erased from the device nor stored in the receiving application ensuring that partial or corrupted data are not made available to the receiving station If the failure mode persists the user should move to a position where the RF signals propagate better and allow successful transmissions WLAN Option Wireless options transmit at 2 4 GHz Other nearby wireless devices may cause interference If possible move or turn off other devices to minimize potential interference The following table shows the channels allocated in different geographic areas in the world Please consult with your IT personnel in order to set the device on the proper channels Specification Description Technology IEEE 802 11 b g DSSS WiFi compliant 2 400 2 4835 GHz U S CAN Japan Europe Frequency 2 471 2 497 GHz Japan U S A CANADA 11 channels 1 11 Europe 13 Channels 1 13 Japan 14 Channels 1 14 France 4 Channels 10 13 Channels USER SAFETY INFORMATION e The following table lists the frequency allocated for each channel used by the WLAN o
29. hen connected to an AC Mains power source only the following AC DC power converters should be attached to the cradle PWR power receptacle e Ault Inc Model MW117 xx0503Fxx variations not affecting safety e Globtek Inc Model GTM21089 1305 T3 e Device captures and presents data reflecting a patient s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis however the data should not be used as a sole means for determining a patient s diagnosis e Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care and adequately trained in the use of this device Before attempting to use this device for clinical applications the operator must read and understand the contents of the user manual and other accompanying documents Inadequate knowledge or training could result in increased risk of harm to users patients and bystanders or damage to the device Contact Physio Control service for additional training options ensure that electrical safety is maintained during operation from AC power the device must be plugged into a hospital grade outlet Where the integrity of external protective earth conductor arrangement is in doubt the device shall be operated from its internal electrical power source To maintain designed operator and patient safety peripheral equipment and accessories used that ca
30. hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC Mains voltage prior to application of the test level XVI ELECTROMAGNETIC COMPATIBILITY EMC Table X 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below The customer or the user of the equipment should ensure that it is used in such an environment Emissions Test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to Compliance Level 3 Vrms 150 kHz to 80 MHz V m 80 MHz to Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 4 5250 3Vrms Mp 80 MHz to 800 MHz 3V m 2 5 GHz 2 5 GHz 7 Wo 800 MHz to 2 5 GHz m 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 meter
31. ile RF communications equipment transmitters and the equipment as recommended in the table below according to the maximum output power of the communications equipment Rated Maximum Output Power of Transmitter W W x sb 150 KHz to 800 MHz 800 MHz to 2 5 GHz Separation Distance According to Frequency of Transmitter m 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 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 the absorption and reflection from structures objects and people XVIII TABLE OF CONTENTS INTRODUCTION SECTION 1 Mannal Pil pp ET T e I TNC u rarest tases ects u su T LO LL LEE I Intended Usa I PANIC ANOS T 1 Bd Ti OIN OTT 2 Figure 1 1 ReadyLink with Cradle and Carry Case aaaaassssssssssssssssssssssssssssssssssa 3 Ji Ta CUMIN Of D uu ma
32. intercostal space Because patients vary with respect to body shape it is difficult to palpate the 15 intercostal space with accuracy Thus locate the 2 intercostal space by first palpating the little bony prominence called the Angle of Lewis where the body of the sternum joins the manubrium This rise in the sternum identifies where the second rib is attached and the space just below it is the 2 intercostal space Palpate and count down the chest until you locate the 4 intercostal space Patient Hookup Summary Table Electrode Position On the 4 intercostal a space at the right CX N sternal border Angle of Lewis 4 A wakra 5 On the 4 intercostal V1 space at the left sternal lt lt i border N 2 Ns Midway between XY BE V2 C2 and V4 C4 E electrodes e Waska SO On the 5 intercostal space at the left RA LA midclavicular line RL LL Midway between V4 and V6 electrodes On the left midaxillary line horizontal with V4 electrode On the deltoid forearm or wrist On the thigh or ankle 14 SECTION 3 Patient Demographic Entry Each time the ReadyLink is turned on or an active record is ended by the user a new record is created with an associated record ID The record ID is a numeric identifier consisting of the time at which the record was created This record ID is displayed at the bottom of the demographic screen and 1s used to identify
33. irectives Indicates power receptacle on the cradle accepts an AC DC power converter See Warnings for additional information GENERAL CARE Precautions Turn off the device before inspecting or cleaning e Do not immerse the device in water e not use organic solvents ammonia based solutions or abrasive cleaning agents which may damage equipment surfaces Inspection Inspect your equipment daily prior to operation If you notice anything that requires repair contact an authorized service person to make the repairs e Verify that all cords and connectors are securely seated e Check the case and chassis for any visible damage e Inspect cords and connectors for any visible damage e Inspect keys and controls for proper function and appearance Cleaning Patient Cables 1 Remove cables and lead wires from device before cleaning 2 Clean the ECG patient cables with a damp sponge or cloth Use only the cleaning agents listed below e Quaternary ammonium compounds e Isopropyl alcohol e Peracetic peroxide acid solution 3 Usecaution with excess liquid as contact with metal parts may cause corrosion Do not immerse cable ends or lead wires immersion can cause metal corrosion 5 Do not use excessive drying techniques such as forced heat p WARNING Do not attempt to clean disinfect the device or patient cables by submerging into a liquid autoclaving or steam cleaning Never expose cables to strong ultra violet ra
34. ity 10 to 95 RH non condensing Storage temperature 20 to 60 C 4 to 140 F Storage humidity 5 to 95 RH non condensing Atmospheric pressure 500 hPa to 1060 hPa vill USER SAFETY INFORMATION The device will automatically turn off blank screen if the batteries have been severely discharged and the AC Mains is disconnected from the device After operating the device using battery power always recharge the device This ensures that the batteries will be automatically recharged for the next time you use the device The display will indicate that the device 1s charging The device is UL classified pSSIF U e WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL L US HAZARDS ONLY IN ACCORDANCE WITH UL2601 1 IEC60601 1 5535 CAN CSA 22 2 No 601 1 AND IEC60601 2 25 When necessary dispose of the device its components and accessories e g batteries cables electrodes and or packing materials in accordance with local regulations Wireless Data Transmission Some Mortara electrocardiographs can be equipped with an optional wireless data transmission module WLAN or GSM GPRS mobile Both these technologies use radios to transmit data to a Mortara receiving application Due to the nature of radio transmissions it s possible that due to the characteristics of the environment where the device is located some other RF sources may interfere with the transmission generated by the device Mortara Instrument
35. k 12 Lead ECG is a 12 lead diagnostic electrocardiograph capable of acquiring viewing transmitting and storing ECG data in mobile treatment environments The ReadyLink is equipped with Mortara Instrument s VERITAS resting ECG interpretation algorithm with age and gender specific criteria The VERITAS algorithm can provide an over reading physician with a silent second opinion through diagnostic statements output on the ECG report Resting ECG Interpretation accuracies have not been validated under patient transport conditions Noise generated during patient transport may impact the accuracy of interpretation For additional information on the VERITAS algorithm please refer to the Physician s Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation The ReadyLink includes ReadyLink 12 Lead ECG Patient cable Patient cable adaptor Cradle Antenna with GSM GPRS mobile and SIM card Carry case Hospital grade power cord with charger Physician s Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation User s manual Quick reference card Training video SECTION 1 ReadyLink with Cradle and Carry Case The ReadyLink ships pre assembled within the carry case as shown below In order to protect the device do not remove it from the carry case WARNING Do not disconnect the patient cable from the device Coil and store cable loosely Inspect cable before each use and replace cable if bulges or other signs of da
36. ly Tel 39 051 298 7811 Fax 39 051 613 3582 Manufacturer s Responsibility Mortara Instrument Inc is responsible for the effects on safety and performance only if Assembly operations extensions readjustments modifications or repairs are carried out only by persons authorized by Mortara Instrument Inc e The device is used in accordance with the instructions for use Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule Failure to do so may cause undue failure and possible health hazards Equipment Identification Mortara Instrument Inc equipment is identified by a serial and reference number on the back of the device Care should be taken so that these numbers are not defaced Copyright and Trademark Notices This document contains information that is protected by copyright All rights are reserved No part of this document may be photocopied reproduced or translated to another language without prior written consent of Mortara Instrument Inc Other Important Information The information in this document is subject to change without notice Mortara Instrument Inc makes no warranty of any kind with regard to this material including but not limited to implied warranties of merchantability and fitness for a particular purpose Mortara Instrument Inc assumes no responsibility for any errors or omissions that may appear in this doc
37. mage are present Figure 1 1 SECTION 1 Bottom of Cradle Figure 1 2 System Connectors LAN connector USB connector for optional bar code scanner or removable data storage DC power inlet Green LED indicating power on Flashing yellow LED indicating LAN connection NOTE The AC DC converter and power cord serve as the AC Mains connection for the ReadyLink To remove AC Mains disconnect the power cord from the socket or AC DC converter cable from the ReadyLink DC power inlet NOTE The AC DC converter is meant for charging only Remove the AC DC converter when device is connected to a patient WARNING Only the specified AC DC power converters should be used See Warnings in the cover section SECTION 1 Display Overview 8 Lead Real Time ECG View Figure 1 3 Heart Rate Or Lead Fault Indicator Speed Gain Filter HR 60 25mm s 10mm uV 150 Hz Function Keys Waveform Display Function Key Labels Battery Feature Keys NOTE Device display defaults to real time ECG view The ReadyLink features a 320 x 240 pixel LCD display for valuable preview of ECG waveform function key labels and other parameters as explained below Heart rate HR When a patient is connected to the electrocardiograph his her HR 1s displayed in real time The HR is the average ventricular rate measured over the 10 second rhythm on a standard ECG HR 15 displayed in the upper left corner o
38. n come in direct patient contact must be in compliance with UL 60601 1 IEC 60601 1 and IEC 60601 2 25 Only use parts and accessories supplied with the device and available through Physio Control Inc e All signal input and output I O connectors are intended for connection of only those devices complying with IEC 60601 1 or other IEC standards e g IEC 60950 as appropriate to the device Connecting additional devices to the device may increase chassis and or patient leakage currents To maintain operator and patient safety consideration should be given to the requirements of IEC 60601 1 1 and leakage currents should be measured to confirm no electric shock hazard exists e To maintain operator and patient safety equipment connected to the same network as the device must meet the requirements of IEC 60950 or IEC 60601 1 e Patient cables intended for use with the device include series resistance 7 Kohm minimum in each lead for defibrillation protection Patient cables should be checked for cracks or breakage prior to use USER SAFETY INFORMATION Conductive parts of the patient cable electrodes and associated connections of type CF applied parts including the neutral conductor of the patient cable and electrodes should not come into contact with other conductive parts including earth ground ECG electrodes could cause skin irritation patients should be examined for signs of irritation or inflammation To avoid the possi
39. n transmitted will be marked with a T in the Archives screen All stored ECGs will remain in the Archive until the Archives become full or if the record s have been deleted Richards Steven Records ID 20101221133823 Records ID 20101251256797 Records ID 20101261284673 Streap Mary Record ID 2010281423667 12 LEAD CANCEL NOTE If the ECG is acquired and stored with the patient name the name will display in the Archive If the name is not entered and only an ID is entered the record will be stored with the date of acquisition and ID number Sample Test Report The ECG Archive comes preloaded with a sample test report This report contains a single test ECG report consisting of triangle waves on each lead This report is intended to be used whenever a test report needs to be sent to the recipient selected under site configuration The test report is clearly distinguishable from a clinical ECG to prevent any confusion Access the sample test report by entering the Archives and selecting the record Test Sample The sample test report is shown below 19 20 Name Test Sample 08 Jul 2044 42 51 45 Record ID 1601001000000 Patient ID Vent rate 240 BPM DOB PR int ms Age 40yr Sex Male QRS dur 263 ms 256 353 ms P R T axes 258 SECTION 5 MARKED RIGHT AXIS DEVIATION QRS AXIS gt 100 INTRAVENTRICULAR CONDUCTION DELAY 132 ms QRS DURATION INFERIOR MYOCARDIAL INFARCTION 40 ms Q WAVE AND O
40. nd Manufacturer s Declaration Electromagnetic Immunity Voltage Fluctuations Flicker Emissions IEC 61000 3 3 The equipment is intended for use the electromagnetic environment specified in the table below The customer or the user of the equipment should ensure that it is used in such an environment Emissions Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field Compliance 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles Compliance Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or
41. nth Day Hour 00 23 Minute Battery Charge Level 9896 u i 12 LEAD CANCEL Modify Timezone Page 1 2 Date Format MM DD YYYY Clock Mode Real Time DST Auto Time Zone Central Standard Time 12 LEAD CANCEL Modify Timezone Page 2 2 Start Dst Month Mar Week Second Day Sunday Time 02 00 End Dst Month Nov Week First Day Sunday Time 02 00 aa 12 LEAD CANCEL l SECTION 2 11 12 SECTION 2 RECORD AN ECG SECTION 3 Patient Preparation Before attaching the electrodes assure the patient fully understands the procedure and what to expect e Privacy is very Important in assuring the patient 15 relaxed e Reassure the patient that the procedure 16 painless and that the electrodes on their skin are all that they will feel e Make sure the patient is lying down and is comfortable If the table is narrow tuck the patient s hands under his her buttocks to ensure their muscles are relaxed e Once all the electrodes are attached ask the patient to lie still and to not talk Explain this will assist you in acquiring a good ECG Preparing Patient Skin Thorough skin preparation is very important There is natural resistance on the skin surface from various sources such as hair oil and dry dead skin Skin preparation is intended to minimize these effects and maximize the quality of the ECG signal To prepare the skin e Shave hair from electrode sites if necessary
42. produce unwanted noise in the ECG signal during acquisition Disconnect the power source and operate from the internal battery when acquiring ECG data e As defined by IEC 60601 1 and IEC 60601 2 25 the device is classified as follows Class I equipment applies to entire product when the handheld unit is docked and to the docking station and or cradle alone or internally powered applies to handheld unit when not docked Type CF defibrillation proof applied parts Ordinary equipment Equipment not suitable for use in the presence of a flammable anesthetic mixture Continuous operation NOTE From safety perspective per IEC 60601 and derivative standards norms this device is declared to be Class I and uses a three prong inlet to ensure an earth connection is made along with mains The ground terminal on the mains inlet on the docking station and or cradle is the only protective earth point in the device Exposed metal accessible during normal operation is double insulated from mains Internal connections to earth ground are functional earth This device is primarily intended for use in hospitals but may be used in mobile environments including pre hospital emergency medical services ambulance and patient transport medical clinics and offices of any size and should be used and stored according to the environmental conditions specified below Operating temperature gt 0 to 40 C 32 to 104 F Operating humid
43. ption Channel Center Frequency Frequency Spread 2 aM ausm 2000 5 Me s 2 osme _ G ed s ee s 22 MHz 24645 order to achieve the best transmission rate it is necessary that the facility where the device is operated provide good area coverage Please consult the IT personnel of the facility to verify the proper WLAN availability in the area where the device will be used e RF wave propagation may be blocked or reduced by the environment where the device is used Most common areas where this may occur are shielded rooms elevators underground rooms In all such situations it is recommended to move the device to a proper location and verify with the IT personnel of the facility the areas where the WLAN signals are available EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention consult accompanying documents Alternating current Protective earth Fuse Telephone line modem Network LAN 4 02 6 2 P Defibrillator proof type CF applied part g ON OFF power Shift key to enter upper case text Space key Enter key accept data return Universal Serial Bus USB Se L gt X1 xli EQUIPMENT SYMBOLS AND MARKINGS Do not dispose as unsorted municipal waste Per EC Directive 2002 96 requires separate handling for waste disposal according to national requirements Antenna Indicates compliance to applicable EEC d
44. recharge the battery The ReadyLink should be connected to the power source for recharging when not in use e Operating time on a full battery charge ECG acquisition only approximately 8 hours e Maximum time required to fully recharge the battery approximately 4 hours SECTION 2 Using the Options Menu The ReadyLink offers several special functions available through the Options menu Select Opt from the real time ECG view and the Options menu is displayed Select Application by Number 1 Archives 2 Set Time Date 3 Site Configuration 4 Configuration Battery Charge Level The following chart summarizes the functions available APPLICATION DEFINITION List of Patient Records stored in the internal memory This Archives option is accessible with either the technician or administrator password Section 5 Set Time Date Current time date and battery charge Section 2 Site Configuration Configure transmission site s Section 6 Access ReadyLink configuration settings This option is fi ms Configuration accessible only with the administrator password Section 6 10 Setting Time and Date 10 11 EZ I5 From real time ECG view select Opt to access the Options menu Using the keyboard select 2 Set Time Date The preprogrammed date and time is displayed The ReadyLink will automatically synchronize the time with the LIFENET system Time synchronization will occur during the
45. s m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radios 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 equipment is used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ELECTROMAGNETIC COMPATIBILITY EMC Table X 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mob
46. ssion to verify the connection between the ReadyLink 12 Lead ECG and the LIFENET System should also be performed regulary by pressing the TEST soft key on the Home screen Recommendations to Biomedical Staff Following any service to the ReadyLink and its cradle or when non compliant operation 15 suspected Mortara Instrument Inc recommends the following procedures e Confirm proper operation e Perform testing to ensure continued electrical safety of the device use IEC 60601 1 or ANSI AAMI ESI methods and limits o patient leakage current o chassis leakage current o earth leakage current o dielectric strength mains and patient circuits Battery Maintenance The ReadyLink houses an internal lithium ion battery e Operating time on a full battery charge ECG acquisition only approximately 8 hours Maximum time to fully recharge battery approximately 4 hours Typical AC power consumption of handheld cradle idle mode battery already charged acquiring ECG 4 5W e Maximum AC power consumption of handheld cradle full charge current 15W Mortara Instrument recommends that the ReadyLink be connected to its power supply for recharging when not in use To maintain optimal battery capacity occasionally use the device without recharging until it reports BATT LOW then recharge again immediately For information about replacing the battery please contact technical support Calibration of the ReadyLink The ReadyLink 1
47. the real time ECG view Using the keyboard select 3 Site Configuration from the Options menu Use A and Y to move back and forth through each configuration option Use Page to toggle to the next available page Use Edit to enter a site name Use to set a default site selection Use Opt to return to real time ECG view Any changes you have made will be saved Use the BKSP key to erase entry errors NOTE Default selection is denoted by three asterisks next to the selected site NOTE Up to 40 sites may be entered NOTE Until a default site is selected the Transmit Report Screen will list Invalid as the Site Name Accessing Configuration Menu The configuration page defines all operational conditions that do not change on a daily or patient to patient basis To access 1 Select Opt from the real time ECG view 2 Using the keyboard select 4 Configuration from the Options menu 3 Enter the administrator password when prompted How to Navigate Configuration Menu Use A and Y to move back and forth through each configuration option Use to toggle through pre programmed available settings per configuration field Use Opt to return to real time ECG view Any changes you have made will be saved Use the BKSP key to erase entry errors 21 SECTION 6 Abbreviated Configuration Settings CONFIGURATION PARAMETER DEFINITION DEFAULT Software Version The software version of the device een Device ID Alphanumeri
48. ument Mortara Instrument Inc makes no commitment to update or to keep current the information contained in this document WARRANTY INFORMATION Your Warranty MORTARA INSTRUMENT INC hereinafter referred to as Mortara hereby warrants that Mortara products hereinafter referred to as Product s shall be free from defects in material and workmanship under normal use service and maintenance for the warranty period of such Product s from Mortara or an authorized distributor or representative of Mortara The warranty period is defined as twelve 12 months following the date of shipment to the end user by Physio Control Normal use service and maintenance means operation and maintenance in accordance with appropriate instructions and or information guides This warranty does not apply to damage to the Product s caused by any or all of the following circumstances or conditions a Freight damage b Parts and or accessories of the Product s not obtained from or approved by Mortara c Misapplication misuse abuse and or failure to follow the Product s instruction sheets and or information guides d Accident a disaster affecting the Product s e Alterations and or modifications to the Product s not authorized by Mortara f Other events outside of Mortara s reasonable control or not arising under normal operating conditions THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR
49. upon acquisition 16 CONNECTIVITY AND ECG TRANSMISSION SECTION 4 ECG Transmission Transmit ECGs using the device s integrated GSM GPRS mobile ReadyLink 12 Lead ECG ships with preinstalled SIM card and is preconfigured to communicate with the Physio Control LIFENET System To transmit records from either real time ECG view or ECG preview select XMT To select a different report s press Rpt Navigate through the reports using A or V use Selec to select the report s to be transmitted Once selected an asterisk will appear to the right of the report To select a different site select Site see Section 6 for more information about site configuration Navigate through the sites using A or W use Selec to select the desired destination site Use Back to return to the transmit screen initiate transmission by pressing Send To transmit ECGs from the ECG Archives press Opt followed by 1 Archives Ifa patient record is active a message will appear Enter Patient Archive Selecting YES will end the current patient record and enter the Archives Select NO if you do not wish to end the current patient record Use A to navigate by line upward through the Archives use Y to move by line downward through the Archive Records will be identified by patient name patient ID or ecord ID A highlighted record will display the time and date of acquisition at the top of the screen View the demographic information for the highlighted re
50. yLink not properly docked is displayed until the error is corrected DOCKED DOCKED is continuously displayed when the unit is docked but no AC is connected applies only when device is used with the cradle in the carrying case Function Keys Function keys activate the LCD label adjacent to each function key LCD labels functions change depending upon the screen displayed If the label is blank the adjacent function key is not active The following descriptions apply to those function keys available in the real time ECG view P ID Use P ID to enter patient ID and demographic information Leads Use Leads to toggle between the eight initial default leads a 3 lead view and between leads I II and III aVR aVL and aVF V1 V2 and V3 or V4 V5 and V6 or to display all 12 leads at one time LCD A Use LCDA to increase display contrast Use LCD to decrease display contrast SECTION 1 Test Use Test to initiate the transmission test function The transmission test automatically initiates a GPRS connection to the cardiology management system synchronizes the time transfers a test file and reports whether the transmission completed successfully This transmission test is intended to be used regularly to verify the continued successful operation of the unit Opt Use Opt to enter the Options menu to access the Archives Clock settings Site settings and configuration settings Feature Keys
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