ELI 280 User Manual Rev J

Copyright © 2018 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

For patent information, please visit www.welchallyn.com/patents This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. AM12, ELI, EScribe, VERITAS, and WAM are trademarks of Mortara Instrument, Inc. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. V2.3.0. 2018-06

TABLE OF CONTENTS TECHNICAL SUPPORT AND SERVICE... 1 HEADQUARTERS ... 1 EUROPEAN UNION REPRESENTATIVE ... 1 SERVICE/TECHNICAL SUPPORT GROUP ... 1 SALES SUPPORT/ ... 1 NOTICES ... 2 WARRANTY INFORMATION ... 3 YOUR MORTARA WARRANTY ... 3 USER SAFETY INFORMATION... 5 WARNING(S) ... 5 CAUTION(S) ... 8 NOTE(S) ... 8 WIRELESS DATA TRANSMISSION ... 10 WLAN OPTION ... 10 EQUIPMENT SYMBOLS AND MARKINGS ... 11 SYMBOL DELINEATION ... 11 GENERAL CARE ... 13 PRECAUTIONS ... 13 INSPECTION ... 13 CLEANING AND DISINFECTING ... 13 ELECTROMAGNETIC COMPATIBILITY (EMC) ... 14 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS ... 15 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 15 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 16 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT . 17 INTRODUCTION ... 22 MANUAL PURPOSE ... 22 AUDIENCE ... 22 INDICATIONS FOR USE ... 22 SYSTEM DESCRIPTION ... 23 SYSTEM ILLUSTRATION ... 24 SIDE VIEW... 24 REAR VIEW... 25 BASE VIEW ... 25 DISPLAY OVERVIEW ... 26 DISPLAY PARAMETERS ... 26 FUNCTION CONTROL ICONS ... 27 SPECIFICATIONS ... 29 ACCESSORIES ... 30 EQUIPMENT PREPARATION... 32 INITIAL STARTUP ... 32 CALIBRATING THE TOUCHSCREEN DISPLAY ... 32 CONNECTING THE ACQUISITION MODULE ... 32 LOADING PAPER ... 33

POWERING THE ELI 280 ... 36 LOW BATTERY FAILSAFE CONDITIONS ... 37 POWER STATUS ... 37 SETTING DATE AND TIME ... 38 TIME SYNCHRONIZATION... 38 INSTALLING THE WLAN ANTENNA ... 39 USING THE WAM OR AM12 ACQUISITION MODULE ... 39 RECORD AN ECG ... 40 PATIENT PREPARATION ... 40 PATIENT HOOKUP ... 40 PATIENT DEMOGRAPHIC ENTRY ... 42 ECG ACQUISITION AND PRINTING WITH WAM OR AM12 ... 45 ECG ACQUISITION ... 45 BEST 10 SECONDS OF ECG... 48 CONFIGURING THE ECG REPORT ... 48 ACQUIRED ECG STORAGE ... 49 ACQUIRING RHYTHM STRIPS ... 49 CONNECTIVITY AND ECG TRANSMISSION ... 51 ECG TRANSMISSION ... 51 INTERNAL MODEM CONNECTION... 52 LOCAL AREA NETWORK (LAN) CONNECTION AND SETUP ... 56 WIRELESS LOCAL AREA NETWORK (WLAN) CONNECTION AND SETUP... 57 TRANSMISSION MEDIA AUTO-SYNC ... 58 USB CONNECTIVITY ... 59 ECG DIRECTORY ... 61 ECG DIRECTORY... 61 SEARCHING ECG RECORDS ... 61 REVIEWING ECG RECORDS ... 62 DELETING ECG RECORDS ... 63 ERASING ECGS FROM THE DIRECTORY ... 63 PRINTING THE ECG DIRECTORY ... 63 ECG ORDERS ... 63 SEARCHING ECG ORDERS ... 64 WORKLIST MANAGEMENT... 64 SYNC COMMAND... 64 MWL QUERY ... 65 CUSTOM ID DOWNLOAD ... 65 PATIENT DEMOGRAPHIC QUERY (PDQ) ... 66 SYSTEM SETTINGS ... 67 MENU COMMANDS AND UTILITIES... 67 DEVICE PASSWORDS... 69 CONFIGURATION SETTINGS: ABOUT ... 70 CONFIGURATION SETTINGS: MODEM ... 71 CONFIGURATION SETTINGS: SYSTEM ... 72 CONFIGURATION SETTINGS: ECG ... 75 CONFIGURATION SETTINGS: LAN ... 79 CONFIGURATION SETTINGS: WLAN ... 80 CONFIGURATION SETTINGS: DATE/TIME ... 82 CONFIGURATION SETTINGS: CUSTOM ID ... 82 CONFIGURATION SETTINGS: NETWORK ... 82

CONFIGURATION SETTINGS: WAM... 82 CONFIGURATION SETTINGS: SERVICE ... 82 MAINTENANCE AND TROUBLESHOOTING ... 83 SYSTEM TROUBLESHOOTING CHART ... 83 TOUCHSCREEN TROUBLESHOOTING CHART ... 85 POWER OFF THE DEVICE ... 86 TEST OPERATION ... 86 RECOMMENDATIONS TO BIOMEDICAL STAFF ... 86 BATTERY MAINTENANCE ... 86 CLEANING THE THERMAL PRINTER ... 87 CLEANING THE TOUCHSCREEN ... 87

TECHNICAL SUPPORT AND SERVICE Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

European Union Representative Mortara Instrument Europe, s.r.l. Via Cimarosa, 103/105 40033 Casalecchio di Reno (Bologna) Italia Tel: +39 051 2987811 Fax: +39 051 6133582 E-mail: clienti.mortarait @ welchallyn.com

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected] 24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 Hospital Customers: Physician Practice: U.S. Distribution:

[email protected] [email protected] [email protected]

Mortara Instrument Germany Hofgartenstraße 16 72379 Hechingen Deutschland Tel.: +49 (0) 7471 98 41 14-0 Fax: +49 (0) 7471 98 41 14-90 E-Mail: info @ welchallyn.com Mortara Instrument Netherlands “Amerika” Gebouw– 7e verdieping Hoogoorddreef 15 1101 BA Amsterdam Nederland Tel.: 020 206 1360 E-mail: infonl @ welchallyn.com Mortara Instrument Australia Head Office Suite 4.01, 2-4 Lyonpark Road Macquarie Park, Sydney NSW 2113 Australia Tel: 1800 650 083 Fax: +61 2 9562 0982 Mortara Instrument UK Clinitron House, Excelsior Road Ashby de la Zouch Leicester LE65 1JG Tel: 0207 365 6780 Fax: 0207 365 9694

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NOTICES 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.

•

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 bottom 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 document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.

2

WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Mortara, or if not otherwise noted, for a period of twenty-four (24) months from the date of shipment. Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. 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 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 (i) 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 (ii) 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.

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WARRANTY INFORMATION

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT 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 BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY P E R I O D . IN NO E V E N T , 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.

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USER SAFETY INFORMATION Warning:

Means there is the possibility of personal injury to you or others.

Caution:

Means there is 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.



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.



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 Mortara service for additional training options.



To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a hospital-grade outlet.



The power supply cord is the MAINS Disconnect device, please ensure the device is positioned to allow access to the cord in the event disconnection is necessary.



Only use parts and accessories supplied with the device and/or are available through Mortara Instrument, Inc.



Patient acquisition devices intended for use with the device include series resistance (9 Kohm minimum) in each lead for defibrillation protection. Patient acquisition devices should be checked for cracks or breakage prior to use.



Conductive parts of the Patient acquisition device, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the Patient acquisition device 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 possibility of serious injury or death during patient defibrillation, do not come into contact with device or Patient acquisition devices. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.



This device does not automatically switch between direct or wireless Patient acquisition devices. Clinician must choose Patient acquisition device before ECG acquisition. If your device is equipped with a receiver for a wireless Patient acquisition device, always make sure that you are receiving data from the expected module.

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USER SAFETY INFORMATION

6



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.



A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.



Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated from its internal electrical power source.



To improve immunity to potential interfering electromagnetic signals, shielded cabling is recommended when connecting the device to a network.



Medical devices have been designed to have a higher degree of protection against electric shock than, for instance, information technology equipment because patients often are connected to multiple devices and also may be more prone to the adverse effect of electric currents than healthy persons. All equipment that is connected to the patient, can be touched by the patient, or can be touched by another person while that person touches the patient at the same time, should have the same level of protection against electric shock as medical equipment. The ELI 280 is a medical device that has been designed to be connected to other devices for the purpose of receiving and transmitting data. Certain measures must be taken to prevent the risk of excessive electric current flow through the operator or patient when connected: 

All electrical equipment that is not medical electrical equipment must be placed outside of the “patient environment,” defined by applicable safety standards to be at least 1.5 meters (5 feet) from the patient. Alternatively, non-medical equipment may be provided with additional protection such as an additional protective earth connection.



All medical electrical equipment that has a physical connection to the ELI 280 or the patient, or is in the patient environment must comply with applicable safety standards for medical electrical devices.



All electrical equipment that is not medical electrical equipment and has a physical connection to the ELI 280 must comply with applicable safety standards, such as IEC 60950 for information technology equipment. This includes information network equipment connected through the LAN connector.



Conductive (metal) parts that can be touched by the operator in normal use and that are connected to nonmedical equipment should not be brought into the patient environment. Examples are connectors for shielded Ethernet or USB cables.



If multiple devices are connected to each other or to the patient, device chassis and patient leakage currents may be increased, and should be measured for compliance with applicable standards for medical electrical systems.



Avoid the use of portable multiple socket outlets. If used and not compliant with medical electrical device standards, an additional protective earth connection is required.



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 is used.

USER SAFETY INFORMATION



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.



When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.



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.



Some Mortara electrocardiographs can be equipped with a 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 device is equipped with such a module. If so equipped, the following notices apply: 

The WLAN identification can be found on a label on the bottom of the device.  Quatech, Inc. Model WLNG-AN-MR551: 2400 MHz (model subject to change without notice)

 Use of the 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. ●

Do not transmit via the WLAN module with a missing or damaged antenna. Replace a damaged antenna immediately.



Use only the antenna supplied for use with this device. Unauthorized antennas, modifications, or attachments could damage the WLAN module and may contravene local RF emission regulations or invalidate type approval.



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 and the head and body of the user and any nearby persons at all times. To help prevent degradation of RF signal and to avoid excess RF energy absorption, do not touch the antenna during data transmission.



The WLAN module complies 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:  Federal Communications Commission (FCC)  Directives of the European Community  Directorate General V in Matters of Radio Frequency Electromagnetic Energy

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USER SAFETY INFORMATION

Caution(s) 

To prevent possible damage to the touchscreen, do not use sharp objects to touch the screen icons, only use fingertips.



Do not attempt to clean the device or patient acquisition device 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 the device.



No user-serviceable parts inside. Screw removal by qualified service personnel only. 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 is a sealed lead-acid type and it is totally maintenance free. If the battery appears to become defective, refer to Mortara Instrument Service Department.



Do not pull or stretch patient acquisition device as this could result in mechanical and/or electrical failures. Patient cables should be stored after forming them into a loose loop.



Calibration of the display is required before initial operation of the unit. No special equipment is needed for the proper operation or maintenance of the device.



When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations.



Proper functioning backup items such as a spare patient cable, front-end device, display monitor, and other equipment are recommended on hand to prevent delayed treatment due to an inoperable device.

Note(s)

8



Patient movement may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device.



Proper patient preparation is important to proper application of ECG electrodes and operation of the device.



The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and tries to identify the most likely switch; however, it is advisable to check the other electrode positions in the same group (limb or chest).



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.



The display of a thick baseline while using the WAM wireless acquisition module (square waves on rhythm printout) could be due to the WAM being turned off or having no battery, or the WAM being out of range or experiencing a calibration error. Review the LED indicator on the WAM to ensure the unit is turned on and has proper battery level. Ensure the WAM is paired correctly and is within recommended proximity of the electrocardiograph, and/or power cycle the WAM to re-calibrate. Review the WAM user manual for details.

USER SAFETY INFORMATION



The display of a thick baseline while using the AM12 acquisition module (square waves on rhythm printout) could be due to an improper auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.



A square wave on the display and rhythm printout could be due to the WAM, the AM12, or lead wires not being connected to the patient.



As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:  Class I equipment or internally powered.  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 a safety perspective, per IEC 60601-1 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 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 intended to be used in a hospital or doctor’s office setting, and should be used and stored according to the environmental conditions specified below: Operating temperature: Operating humidity:

+10° to +40°C (+50° to +104°F) 10% to 95% RH, non-condensing

Storage temperature: Storage humidity:

-40° to +70°C (-40° to +158°F) 10% to 95% RH, non-condensing

Atmospheric pressure:

500 hPa to 1060 hPa



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 reconnect the power cord. This ensures that the batteries will be automatically recharged for the next time you use the device. A light next to the on/off switch will illuminate indicating that the device is charging.



WAM must be paired to electrocardiograph before operation.



The device must be configured at the factory for use with the WAM.



The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, AND IEC60601-2-25

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USER SAFETY INFORMATION

Wireless Data Transmission 

Some Mortara electrocardiographs can be equipped with an optional wireless data transmission module (WLAN or GSM). 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 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 in 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 may propagate better and allow successful transmissions.

WLAN Option 

Wireless options transmit in the 2.4 GHz or 5 GHz range. Other nearby wireless devices in the same frequency range may cause interference. If possible, move or turn off other devices to minimize potential interference.



The Wireless LAN module used is compliant with the IEEE 802.11 a, b, g and n standards.



Access Points used should respect IEEE 802.11 standards as well as local Radio Frequency regulations. The device will scan the available channels and connect to the Access Point on the channel where the SSID that is configured on the device is available.



The following table shows the radio channels allocated in different geographic areas in the world. For bands 802.11b and g, only channels 1, 6, 11 and 14 (Japan only) are non-overlapping; for band 802-11a, channels shown represent non-overlapping channel numbers. Band

802.11b

802.11g

Typical Power 15 dBm / 32 mW

13 dBm / 18 mW

17 dBm / 50 mW

Region

No. of channels 11

Channel numbers

USA/Canada

Frequency Range (GHz) 2.401 - 2.473

Europe

2.401 - 2.483

13

1 – 13

Japan

2.401 - 2.495

14

1 – 14

USA/Canada

2.401 - 2.473

11

1 – 11

Europe

2.401 - 2.483

13

1 – 13

Japan

2.401 - 2.483

13

USA/Canada

5.15 - 5.35, 5.725 - 5.825 5.15 - 5.35, 5.47 - 5.725 4.91 – 4.99, 5.15 - 5.35, 5.47 - 5.725 5.725 - 5.825

13

1 – 13 36,40,44,48,52,56,60,64,149,153,157, 161,165 36,40,44,48,52,56,60,64,100,104,108, 112,116,120,124,128,132,136,140 36,40,44,48,52,56,60,64,100,104,108, 112,116,120,124,128,132,136,140,184 188,192,196 149,153,157,161,165

Europe 802.11a

Japan

China

19 23

5

1 – 11



In order to achieve the best transmission rate, it is necessary that the facility where the device is operated can 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.



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 where the WLAN frequencies are available.

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EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents

Alternating current

Protective earth symbol (appears on inside of unit)

Fuse symbol (appears on inside of unit) Telephone line (modem)

Network (LAN)

Universal Serial Bus (USB)

Defibrillator-proof type CF applied part

Input

ON/OFF (power)



Shift key (to enter upper case text on keyboard)

Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements

Antenna

Indicates compliance to applicable European Union directives

11

EQUIPMENT SYMBOLS AND MARKINGS

Patient Information

Initiate Acquisition Of ECG

Initiate Printing Of Continuous Rhythm Strip

Initiate Transmission Of Records

Stop Rhythm Print Out

Configuration (Settings) Menu

Home (returns user to the real-time acquisition screen)

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GENERAL CARE Precautions   

Turn off the device before inspecting or cleaning. Do not immerse the device in water. Do 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.  Verify that all cords and connectors are securely seated.  Check the case and chassis for any visible damage.  Inspect cords and connectors for any visible damage.  Inspect keys and controls for proper function and appearance.

Cleaning and Disinfecting 1. 2. 3.

Disconnect the power source. Remove cables and lead wires from device before cleaning. For general cleaning of cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild soap and water solution. Wipe and air dry. For disinfecting the exterior surfaces of the device, patient acquisition module, cables and lead wires, wipe exterior using: Clorox Healthcare® Bleach Germicidal Wipes (use according to instructions on product label), or a soft, lint-free cloth with a solution of Sodium Hypochlorite (10% household bleach and water solution) minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution as recommended by the APIC Guidelines for Selection and Use of Disinfectants.

WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning. Do not expose cables to strong ultra-violet radiation. Do not sterilize the device or lead wires with Ethylene Oxide (EtO) gas. Do not immerse cable ends or lead wires; immersion can cause metal corrosion. Use caution with excess liquid as contact with metal parts may cause corrosion. Do not use excessive drying techniques such as forced heat. 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.

13

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. 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 appropriate EMC table 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 in increased emissions or decreased immunity of the equipment.

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions 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

Compliance

Electromagnetic Environment: Guidance

RF Emissions CISPR 11

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.

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Complies

The equipment is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Complies

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

Compliance

Compliance Level

Electromagnetic Environment: Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

+/- 6 kV contact +/- 8 kV air

+/- 6 kV contact +/- 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

+/- 2 kV for power supply lines +/- 1 kV for input/output lines

+/- 2 kV for power supply lines +/- 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

+/- 1 kV differential mode +/- 2 kV common mode

+/- 1 kV differential mode +/- 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

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.

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