ELI 380 User Manual Rev H March 2019

Copyright © 2017 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, 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. S o f t w a r e V2.4.1 2019-01 User manual revision: 2019-03

TABLE OF CONTENTS 1.

GENERAL STATEMENTS ... 1 TECHNICAL SUPPORT AND SERVICE... 1 EUROPEAN UNION REPRESENTATIVE... 1 SERVICE/TECHNICAL SUPPORT GROUP ... 1 SALES SUPPORT/ ... 1

2.

NOTICES ... 2 MANUFACTURER’S RESPONSIBILITY ... 2 RESPONSIBILITY OF THE CUSTOMER ... 2 EQUIPMENT IDENTIFICATION ... 2 COPYRIGHT AND TRADEMARK NOTICES ... 2 OTHER IMPORTANT INFORMATION ... 2

3.

WARRANTYINFORMATION... 3 YOUR MORTARA WARRANTY ... 3

4.

USER SAFETY INFORMATION ... 5 WARNINGS ... 5 CAUTIONS ... 8 FCC COMPLIANCE STATEMENT FOR THE WAM ... 9 INDUSTRY CANADA COMPLIANCE STATEMENT FOR THE WAM ... 9 FCC COMPLIANCE STATEMENT FOR WLAN MODULE OPTION ... 10 INDUSTRY CANADA COMPLIANCE STATEMENT FOR WLAN MODULE OPTION ... 11 INDUSTRY CANADA (IC) EMISSIONS ... 11 NOTES ... 12

5.

EQUIPMENT SYMBOLS AND MARKINGS ... 15 SYMBOL DELINEATION ... 15 DISPLAY ICONS AND KEYBOARD BUTTONS ... 16

6.

GENERAL CARE ... 17 PRECAUTIONS... 17 INSPECTION ... 17 CLEANING LEAD WIRES AND CABLES, PATIENT ACQUISITION DEVICE AND ELECTROCARDIOGRAPH ... 17

7.

ELECTROMAGNETIC COMPATIBILITY (EMC) ... 19 EMC COMPLIANCE ... 19 WAM AND AM12 ... 20 ELI 380 WITH LAIRD WB45NBT FIPS COMPLIANT WLAN MODULE ... 23 ELI 380 WITH B&B ELECTRONICS WLNN-SP-DP551 NON-FIPS WLAN MODULE ... 26 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT ... 29

8.

INTRODUCTION ... 31 MANUAL PURPOSE ... 31 AUDIENCE ... 31 INDICATIONS FOR USE ... 31 CONTRAINDICATIONS ... 31 SYSTEM DESCRIPTION ... 32

SYSTEM ILLUSTRATION... 33 SIDE VIEW ... 33 REAR VIEW ... 34 BASE VIEW... 34 SWIVEL TOUCHSCREEN MODEL ... 35 ELI 380 CAPACITIVE-TOUCH GLASS KEYBOARD WITH TOUCHPAD ... 35 CLEANING MODE ... 35 NAVIGATION OVERVIEW ... 35 POWER STATUS ... 36 SYMBOLS ENTRY ... 36 DISPLAY OVERVIEW ... 36 SPECIFICATIONS ... 41 LOCAL AREA NETWORK (LAN) SPECIFICATIONS ... 42 WIRELESS LOCAL AREA NETWORK (WLAN) OPTION SPECIFICATIONS ... 43 ACCESSORIES... 45 9.

EQUIPMENTPREPARATION ... 47 INITIAL STARTUP ... 47 CONFIGURING THE AMXX ACQUISITION MODULE ... 47 CONFIGURING THE WAM WIRELESS ACQUISITION MODULE ... 47 ELI 380 CONFIGURATION FOR ALL USERS ... 48 LOADING PAPER ... 49 POWERING THE ELI 380 ... 50 POWER STATUS ... 51 POWER OFF ... 51

10.

RECORD AN ECG... 53

PATIENT PREPARATION ... 53 PATIENT HOOKUP... 53 PATIENT DEMOGRAPHIC ENTRY ... 57 ECG ACQUISITION AND PRINTING WITH WAM OR AMXX ... 61 BEST 10 SECOND ECG ... 65 11.

CONNECTIVITY AND ECG TRANSMISSION ... 67

ECG TRANSMISSION ... 67 USB DEVICE CONNECTION ... 67 12.

ECG REVIEW AND MANAGEMENT ... 69

REVIEWING ECG RECORDS ... 69 DIRECTORY ... 70 MODALITY WORKLIST (MWL) ... 72 PATIENT LIST... 73 PATIENT DEMOGRAPHIC QUERY (PDQ) ... 74 PRINTOUTS ... 74 13.

CONFIGURATIONSETTINGS ... 75

MENU COMMANDS AND UTILITIES ... 75 CONFIGURATION MENU: ABOUT... 77 CONFIGURATION MENU: CUSTOM ID ... 77 CONFIGURATION MENU: DATE/TIME ... 77 CONFIGURATION MENU: WAM/AMXX ... 78 CONFIGURATION MENU: NETWORK ... 78

CONFIGURATION MENU: PRINT ... 78 CONFIGURATION MENU: OPTIONS CODE ... 78 CONFIGURATION MENU: SYSTEM... 79 CONFIGURATION MENU: ECG... 81 CONFIGURATION MENU: ALTERNATE PLACEMENT ... 84 CONFIGURATION MENU: LOCAL AREA NETWORK (LAN) CONNECTION AND SETUP ... 84 DETERMINE WLAN MODULE TYPE ... 86 CONFIGURATION MENU: WIRELESS LOCAL AREA NETWORK (WLAN) CONNECTION AND SETUP ... 86 CONFIGURATION MENU: PASSWORDS ... 91 CONFIGURATION SETTINGS: SERVICE... 91 14.

MAINTENANCE AND TROUBLESHOOTING ... 93

SYSTEM TROUBLESHOOTING CHART ... 93 ECG TROUBLESHOOTING CHART ... 93 TRANSMISSION TROUBLESHOOTING CHART ... 94 DISPLAY TROUBLESHOOTING CHART ... 96 REBOOT THE DEVICE ... 97 TEST OPERATION ... 97 RECOMMENDATIONS TO BIOMEDICAL STAFF ... 97 CLEANING THE THERMAL PRINTER ... 97 APPENDIX ... 99 LOADING CERTIFICATES ON THE ELI 380 ... 99

1. GENERAL STATEMENTS 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: www.welchallyn.com

European Union Representative Mortara Instrument Europe, s.r.l. Via Cimarosa, 103/105 40033 Casalecchio di Reno (Bologna) Italy Tel: +39 051 2987811 Fax: +39 051 6133582

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]

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 Mortara Instrument Germany Hofgartenstraße 16 72379 Hechingen Germany Tel.: +49 (0) 7471 98 41 14-0 Fax: +49 (0) 7471 98 41 14-90 Mortara Instrument Netherlands “Amerika” Gebouw– 7e verdieping Hoogoorddreef 15 1101 BA Amsterdam The Netherlands Tel.: 020 206 1360 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

1

2. 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. This manual must be kept in a safe place to prevent its deterioration and/or alteration. The user and Mortara Instrument, Inc. authorized personnel must have access to this manual at any time. The user of this device must periodically check the accessories, their functionality and integrity.

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

3. 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.

3

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 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.

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4. 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.

NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only. Consult the actual screen in the host language for specific wording.

WARNINGS 1.

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.

2.

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.

3. 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. 4.

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

5.

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

6.

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

7.

The ELI 380 uses lithium-ion batteries. The following precautions should be taken regarding the batteries: o o o o o o

Do not immerse the device in water. Do not heat or throw the device in fire. Do not leave the device in conditions over 60 ºC or in a heated car. Do not attempt to crush or drop the device. Only use the approved Mortara battery pack with the ELI 380. Follow the disposal instructions in the ELI 380 Service Manual when the device is taken out of service.

8.

The ELI 380 battery/batteries must be initially fully charged prior to use. Ideally, the battery/batteries must be fully charged and fully discharged several times to allow for optimal performance.

9.

Portions of the device are constructed from glass. If the machine is dropped, or otherwise impacted this glass can shatter. Broken glass can cause injurious cuts.

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USER SAFETY INFORMATION

10. The movable touchscreen display can pinch fingers when closing. Use caution when closing and opening the display. 11. Conductive parts of the acquisition module(s), electrodes, and associated connections of type CF applied parts, including the neutral conductor of the acquisition module(s) and electrodes, should not come into contact with other conductive parts including earth ground. 12. ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation. 13. To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with the device or acquisition module(s). Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient. 14. This device does not automatically switch between direct or wireless acquisition modules. Clinician must choose the type of acquisition module before ECG acquisition. If your device is equipped with a receiver for a wireless acquisition module, always make sure that you are receiving data from the expected module. 15. 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. 16. 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. 17. A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. 18. Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated from its internal electrical power source. 19. 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 380 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:

6

•

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 380 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 380 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.

USER SAFETY INFORMATION

•

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.

20. 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. 21. 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. 22. Other medical equipment, including but not limited to defibrillators and ultrasound machines, may cause interference with the ECG signals recorded by the device. 23. 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. 24. Unauthorized connection to IT networks could result in previously unidentified risks to patients, operators, or third parties. The manufacturer is not liable for these additional risks, as the identification, analysis, evaluation, and control should be conducted by the responsible organization. Changes to the IT network could also introduce new risks that require additional analysis. This includes changes in network configuration, connection of additional items, disconnection of items, update of equipment, and upgrade of equipment. 25. Some Mortara electrocardiographs can be equipped with a wireless LAN (WLAN) module for transmitting ECG records. Device labeling 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. • B&B electronics1 WLNN-SP-MR551 (non-FIPS) 1 manufacturer also called B+B SmartWorx •

Laird Model WB45NBT (FIPS mode support) (model subject to change without notice)

26. 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. 27. 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 and the head and body of the user and any nearby persons at all times. 28. 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

CAUTIONS 1. Do not attempt to clean the device or acquisition module by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. 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. 2. 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. 3.

The rechargeable internal battery is a sealed lithium-ion type. If the battery appears to become defective, refer to Mortara Technical Support.

4.

Do not pull or stretch the acquisition module lead wires and cable as this could result in mechanical and/or electrical failures.

5.

Proper functioning backup items such as spare lead wires, front-end device, and other equipment are recommended on hand to prevent delayed treatment due to an inoperable device.

6.

The WAM will only work with receiving devices that are equipped with the appropriate option.

7.

No user-serviceable parts are inside the WAM. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use.

8.

This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) devices, etc.

9.

The following equipment may cause interference with the WAM RF channel: microwave ovens, diathermy units with LANs (spread spectrum), amateur radios, and government radar.

10. When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. 11. AA batteries are known to leak their contents when stored in unused equipment. Remove battery from WAM when not used for an extended period of time. 12. Be careful to insert the connector block into the appropriate input connector by matching the lead wire labels to the WAM or AMxx label. (AMxx refers to USB equipped acquisition modules. Examples of AMxx acquisition modules include AM15E, AM12M, and AM12).)

8

USER SAFETY INFORMATION

FCC Compliance Statement for the WAM In the United States use of this device is regulated by the Federal Communications Commission (FCC). The WAM with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure. FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device. WAM FCC ID: HJR-WAM2500 UTK FCC ID: HJR-UTK2500

These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation.

Industry Canada Compliance Statement for the WAM These devices comply with RSS-210 of the Industry Canada rules. Operation is subject to the following two conditions: 1. This device may not cause interference, and 2. This device must accept any interference, including interference that may cause undesired operation of the device. WAM IC: UTK IC:

3758B-WAM2500 3758B-UTK2500

The term “IC:” before the certification/registration number only signifies that the Industry Canada technical specifications were met.

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USER SAFETY INFORMATION

FCC Compliance Statement for WLAN module option In the United States use of this device is regulated by the Federal Communications Commission (FCC). The WLAN with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure. FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device. As a device option one of the following WLAN modules can be populated:

Laird WB45NBT FCC ID: SQG-WB45NBT or B&B electronics1 WLNN-SP-MR551 FCC ID: F4AWLNN551 1 manufacturer also called B+B SmartWorx This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation.

10

USER SAFETY INFORMATION

Industry Canada Compliance Statement for WLAN module option As a device option one of the following WLAN modules can be populated:

Laird WB45NBT IC:

3147A-WB45NBT

or B&B electronics1 WLNN-SP-MR551 IC: 3913A-WLNN551 1 Manufacturer also called B+B SmartWorx The term “IC:” before the certification/registration number only signifies that the Industry Canada technical specifications were met.

Industry Canada (IC) emissions RF Radiation Hazard Warning Using higher gain antennas and types of antennas not certified for use with this product is not allowed. The device shall not be co-located with another transmitter. Cet avertissement de sécurité est conforme aux limites d'exposition définies par la norme CNR-102 at relative aux fréquences radio. This device complies with RSS 210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device. L’utilisation de ce dispositif est autorisée seulement aux conditions suivantes: (1) il ne doit pas produire de brouillage et (2) l’ utilisateur du dispositif doit étre prêt à accepter tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettre le fonctionnement du dispositif.

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USER SAFETY INFORMATION

Notes 1.

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

2.

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

3.

The algorithm detecting electrode reversal 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).

4.

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.

5.

The WAM LEDs will automatically start flashing if the batteries have been discharged below 1.0 volts.

6.

During normal WAM/AMxx operation, the green LED will display continuously.

7.

If the WAM battery cover is opened during transmission, the device will stop transmitting. The battery must be reinserted and the cover must be applied to resume operation.

8.

The WAM will automatically turn off (LEDs off) if the battery has been severely discharged.

9.

The WAM will automatically turn off when the electrocardiograph is powered down.

10. The WAM will automatically turn off after being disconnected from the patient. This will happen regardless of ELI 380 battery/AC power state. 11. The display of absent waveform while using the WAM wireless acquisition module 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. 12. The display of absent waveform display while using the AMxx acquisition module could be due to an improper auto-calibration. Reconnect the AMxx or power cycle the electrocardiograph. 13. Square waves on the display and rhythm printout could be due to the WAM or the AMxx lead wires not being connected to the patient. 14. 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.

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USER SAFETY INFORMATION

15. 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

16. The device will automatically turn off (blank screen) if the batteries have been severely discharged and the AC mains is disconnected from the device. 17. 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. 18. When using the WAM, it must be paired to electrocardiograph before operation. 19. The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH AAMI ES 60601-1(2012), CAN/CSA C22.2 No. 60601-1(2014), IEC 60601-1(2012), AND IEC 60601-2-25(2011)

20. The WAM 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, IEC60601-2-25,

Wireless Data Transmission 21. ELI 380 electrocardiographs are equipped with a wireless data transmission module (WLAN). This technology uses 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 WLAN signals may propagate better to allow successful transmissions. WLAN 22. 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. 23. The Wireless LAN module used is compliant with the IEEE 802.11 a, b, g and n standards.

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USER SAFETY INFORMATION

24. 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. 25. 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. 26. 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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5. EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document. CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. Follow instructions/directions for use (DFU) -- mandatory action.

Alternating current

Protective earth symbol (appears on inside of unit)

Fuse symbol (appears on inside of unit) Network (LAN)

Universal Serial Bus (USB)

Defibrillator-proof type CF applied part

Patient Cable Input

ON/OFF (Standby/power)



Shift key (to enter upper case text on keyboard) Do not dispose as unsorted municipal waste. Requires separate handling for waste disposal according to local requirements

Indicates compliance to applicable European Union directives

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