ELI 380 User Manual Rev L

© 2020 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn, Inc. Welch Allyn is a registered trademark of Welch Allyn, Inc. AM12, ELI, VERITAS, and WAM are trademarks of Welch Allyn, Inc. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. Software V2.5.X The information in this document is subject to change without notice.

PATENT/PATENTS hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. Hillrom Technical Support For information about any Hillrom product, contact Hillrom Technical Support at 1.888.667.8272, [email protected].

9515-189-50-ENG Rev L Revision date: 2020-08 901133 ELECTROCARDIOGRAPH

and EU IMPORTER Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA

Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland

Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park NSW 2113 Phone 800 650 083

hillrom.com Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc.

TABLE OF CONTENTS 1.

NOTICES ... 5 MANUFACTURER’S RESPONSIBILITY ... 5 RESPONSIBILITY OF THE CUSTOMER ... 5 EQUIPMENT IDENTIFICATION... 5 COPYRIGHT AND TRADEMARK NOTICES ... 5 OTHER IMPORTANT INFORMATION... 6 NOTICE TO EU USERS AND/OR PATIENTS ... 6

2.

WARRANTYINFORMATION ... 7 YOUR WELCH ALLYN WARRANTY ... 7

3.

USER SAFETY INFORMATION ... 8

4.

EQUIPMENT SYMBOLS AND MARKINGS ... 14 SYMBOL DELINEATION ... 14 PACKAGE SYMBOL DELINEATION ... 18 DISPLAY ICONS AND KEYBOARD BUTTONS ... 19

5.

GENERAL CARE... 20 PRECAUTIONS... 20 INSPECTION... 20 CLEANING AND DISINFECTING ... 20 DISPOSAL ... 21

6.

ELECTROMAGNETIC COMPATIBILITY (EMC) ... 22 EMC COMPLIANCE ... 22 WAM AND AMXX GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS... 23 ELI 380 WITH LAIRD WB45NBT FIPS COMPLIANT WLAN MODULE ... 26 ELI 380 WITH B&B ELECTRONICS WLNN-SP-DP551 NON-FIPS WLAN MODULE ... 29 REGULATORY RADIO COMPLIANCE ... 33 INDUSTRY CANADA (IC) EMISSIONS ... 34 EUROPEAN UNION ... 35 RADIO COMPLIANCE TABLE ... 36

7.

INTRODUCTION ... 38 MANUAL PURPOSE ... 38 SYSTEM DESCRIPTION ... 38 SYSTEM ILLUSTRATION ... 39 BASE VIEW ... 41 DISPLAY OVERVIEW ... 43 SPECIFICATIONS ... 47 WAM / UTK ... 51

8.

EQUIPMENT PREPARATION ... 54 INITIAL STARTUP ... 54 CONFIGURING THE AMXX ACQUISITION MODULE ... 54 IMPORTANT VERSION INFORMATION FOR WAM (WIRELESS ACQUISITION MODULE)... 55 CONFIGURING THE WAM WIRELESS ACQUISITION MODULE ... 55 ELI 380 CONFIGURATION FOR ALL USERS ... 55

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TABLE OF CONTENTS

POWERING THE ELI 380 ... 58 USING THE WAM ACQUISITION MODULE ... 60 USING THE AM12/AM15 ACQUISITION MODULE... 60 USING THE AM12M ACQUISITION MODULE ... 60 9.

RECORD AN ECG ... 61 PATIENT PREPARATION ... 61 ECG ACQUISITION AND PRINTING WITH WAM OR AMXX ... 69

10.

CONNECTIVITY AND ECG TRANSMISSION ... 75

ECG TRANSMISSION ... 75 USB DEVICE CONNECTION... 75 11.

ECG REVIEW AND MANAGEMENT ... 77

REVIEWING ECG RECORDS ... 77 DIRECTORY ... 78 MODALITY WORKLIST (MWL) ... 80 PATIENT LIST... 81 12.

CONFIGURATIONSETTINGS ... 83

MENU COMMANDS AND UTILITIES ... 83 CONFIGURATION MENU: ABOUT... 86 CONFIGURATION MENU: CUSTOM ID ... 86 CONFIGURATION MENU: DATE/TIME ... 87 CONFIGURATION MENU: SYSTEM ... 88 CONFIGURATION MENU: ECG... 90 CONFIGURATION MENU: ALTERNATE PLACEMENT ... 94 CONFIGURATION MENU: LOCAL AREA NETWORK (LAN) CONNECTION AND SETUP... 94 DETERMINE WLAN MODULE TYPE ... 96 CONFIGURATION MENU: WIRELESS LOCAL AREA NETWORK (WLAN) CONNECTION AND SETUP ... 96 CONFIGURATION MENU: PASSWORDS ... 100 CONFIGURATION SETTINGS: SERVICE... 100 13.

MAINTENANCE AND TROUBLESHOOTING ... 101

SYSTEM TROUBLESHOOTING CHART ... 101 ECG TROUBLESHOOTING CHART ... 101 TRANSMISSION TROUBLESHOOTING CHART ... 103 DISPLAY TROUBLESHOOTING CHART ... 104 REBOOT THE DEVICE ... 104 TEST OPERATION ... 104 RECOMMENDATIONS TO BIOMEDICAL STAFF ... 105 CLEANING THE THERMAL PRINTER ... 105 14.

APPENDIX ... 106

LOADING CERTIFICATES ON THE ELI 380 ... 106

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1. NOTICES Manufacturer’s Responsibility Welch Allyn, 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 Welch Allyn, 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 Welch Allyn, 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 Welch Allyn, 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. The ELI 380 product label is applied showing the unique identification numbers along with other important information printed on the label. The serial number format is as follows: YYYWWSSSSSSS YYY = First Y is always 1 followed by two-digit Year of manufacture WW = Week of manufacture SSSSSSS = Sequence number of manufacture The UDI label (when applicable) is placed below the product label. This label is placed to the right of the product label. AMXX Module Identification The wired Acquisition Module is identified with a product label on the back of the device and will have its own unique serial number and UDI label applied. Wireless Module Identification The Wireless Acquisition Module (WAM) is identified with a product label on the back of the device and has its own unique serial number and UDI label applied. The ELI 380 UTK label is placed below the product label.

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 Welch Allyn, Inc.

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NOTICES

Other Important Information The information in this document is subject to change without notice. Welch Allyn, 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. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Welch Allyn, Inc. makes no commitment to update or to keep current the information contained in this document.

Notice to EU Users and/or Patients Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

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2. WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn 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 Welch Allyn, 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 Welch Allyn; 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 Welch Allyn; f) Other events outside of Welch Allyn’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 WELCH ALLYN TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Welch Allyn of any alleged defects promptly after discovery thereof within the warranty period. Welch Allyn’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 Welch Allyn’s principal place or any other place as specifically designated by Welch Allyn or an authorized distributor or representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Welch Allyn is limited and that Welch Allyn does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Welch Allyn is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN 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 A N D W E L C H ALLYN I S N O T I F I E D W I T H I N T H E W A R R A N T Y P E R I O D . IN N O E V E N T , INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL WELCH ALLYN 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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3. 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. 2.

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.

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 Welch Allyn 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 Welch Allyn, Inc.

6.

Welch Allyn 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 Welch Allyn 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.

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

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USER SAFETY INFORMATION

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: • 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. • 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 Welch Allyn electrocardiographs can be equipped with a wireless LAN (WLAN) module for

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USER SAFETY INFORMATION

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 29. This product complies with relevant electro-magnetic interference, mechanical safety, performance, and biocompatibility standards. However, the product cannot completely eliminate potential patient or user harm from the following: • Harm or device damage associated with electro-magnetic hazards, • Harm from mechanical hazards, • Harm from device, function, or parameter unavailability, • Harm from misuse error, such as inadequate cleaning, and/or • Harm from device exposure to biological triggers that may result in a severe systemic allergic reaction 30. The device and IT Network the device is connected to should be securely configured and maintained per the IEC 80001 standard, or an equivalent network security standard or practice. 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 Welch Allyn 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.

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USER SAFETY INFORMATION

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 AM15, AM12M, and AM12).)

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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 displays 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. 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: +10° to +40°C (+50° to +104°F) Operating humidity: 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.

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USER SAFETY INFORMATION

19. The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ES 60601-1(2005), CAN/CSA C22.2 No. 60601-1(2008), IEC 606011(2005), E IEC 60601-2-25(2011)

Wireless Data Transmission 20. ELI 380 electrocardiographs are equipped with a wireless data transmission module (WLAN). This technology uses radios to transmit data to a Welch Allyn 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. Welch Allyn 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 21. 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. 22. The Wireless LAN module used is compliant with the IEEE 802.11 a, b, g and n standards.

23. 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. 24. 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. 25. 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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4. 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. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Hillrom for delivery within 7 calendar days. 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 to according local requirements as per 2012/19/EU

Indicates compliance to applicable European Union directives

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EQUIPMENT SYMBOLS AND MARKINGS

Serial Number

Non-ionizing electromagnetic radiation Version 2 UTK indicator (next to ECG Input)

Medical Device

Model Identifier

Product reference

Manufacturer Authorized representative in the European Community

Global Trade Item Number

Battery Charger level

ECG Patient Cable Input

Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM).

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EQUIPMENT SYMBOLS AND MARKINGS

KC Mark (South korea)

Radio approval symbol for Pakistan

Conatel Approval symbol for Paraguay

Eurasia Certification

UL approved mark

CE symbol

Verbiage may vary. Background may be yellow if print is not black and white

Do not re-use, Single use device

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EQUIPMENT SYMBOLS AND MARKINGS

Lot number

Use by date

Not made with natural rubber latex

Prescription only or "For Use by or on the order of a licensed medical professional"

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EQUIPMENT SYMBOLS AND MARKINGS

Package Symbol Delineation

Keep away from sunlight

This way up

Fragile

Keep dry

Temperature limit

Humidity limitation

Atmospheric pressure limitation

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EQUIPMENT SYMBOLS AND MARKINGS

Display Icons and Keyboard Buttons

Patient Information

ECG Acquisition

Rhythm Print

Synchronize

Configuration

Home

Full disclosure page up

ECG Acquisition from full disclosure selection

Full disclosure page down

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5. GENERAL CARE Precautions • • •

Power 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 Disinfecting agents The ELI 380 is compatible with the following disinfectants: •

Clorox Healthcare® Bleach Germicidal Wipes (use according to instructions on product label), or

•

a soft, lint-free cloth dampened 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.

Caution: Disinfecting or cleaning agents that contain Quaternary Ammonium Compounds (Ammonium Chlorides) have been identified as having negative effects if used to disinfect the product. Use of such agents may result in discoloration, cracking, and deterioration of the external housing of the device.

Cleaning To clean the ELI 380: 1.

Disconnect the power source.

2.

Remove cables and lead wires from device before cleaning.

3.

Thoroughly wipe the surface of the ELI 380 with a clean, lint-free cloth dampened with a mild detergent and water for general cleaning or use one of the above recommended agents for disinfection.

4.

Dry the device with a clean, soft, dry, lint-free cloth.

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