ELI 150C and ELI 250C User Manual Ver a

© 2022 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., E-Scribe, ELI, and VERITAS are trademarks of Welch Allyn, Inc., Cisco® is the registered trademark of Cisco Systems, Inc. DICOM® is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. Software. V2.2.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].

80029899 Ver A Revision Date: 2022-06 (150c) 901129 ELECTROCARDIOGRAPH (250c) 901131 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 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 WARRANTY INFORMATION ... 7 YOUR WELCH ALLYN WARRANTY ... 7 USER SAFETY INFORMATION ... 9 WARNING(S)... 9 CAUTION(S) ... 12 NOTE(S) ... 12 WIRELESS DATA TRANSMISSION... 14 WLAN OPTION ... 15 EQUIPMENT SYMBOLS AND MARKINGS ... 17 SYMBOL DELINEATION ... 17 PACKAGE SYMBOL DELINEATION ... 20 GENERAL CARE ... 21 PRECAUTIONS... 21 INSPECTION... 21 CLEANING AND DISINFECTING THE ELI 150C AND ELI 250C ... 21 DISPOSAL ... 22 ELECTROMAGNETIC COMPATIBILITY (EMC) ... 23 EMC COMPLIANCE ... 23 ELI 150C GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS... 24 ELI 150C GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 25 ELI 150C GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 26 ELI 250C GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS... 27 ELI 250C GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 28 ELI 250C GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 29 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT... 30 REGULATORY RADIO COMPLIANCE ... 31 INTRODUCTION ... 37 MANUAL PURPOSE... 37 AUDIENCE ... 37 SYSTEM DESCRIPTION ... 37 INTENDED USE (FUNCTIONAL PURPOSE) ... 38 INDICATIONS FOR USE ... 38 SYSTEM ILLUSTRATIONS* ... 39 DISPLAY AND KEYBOARD*... 41 DISPLAY OVERVIEW ... 42 ELI 150C SPECIFICATIONS ... 44 ELI 250C SPECIFICATIONS ... 45 ACCESSORIES... 47 3

TABLE OF CONTENTS

EQUIPMENT PREPARATION ... 49

INITIAL STARTUP ... 49 CONNECTING THE ACQUISITION MODULE ... 49 LOADING PAPER ... 50 APPLYING POWER ... 53 LOG-IN SCREEN ... 54 SETTING TIME AND DATE ... 54 IMPORTANT VERSION INFORMATION FOR WAM (WIRELESS ACQUISITION MODULE)... 54 USING THE WAM ACQUISITION MODULE ... 56 USING THE AM12 ACQUISITION MODULE ... 56 INSTALLING THE WLAN ANTENNA ... 56 RECORD AN ECG ... 57 PATIENT PREPARATION ... 57 PATIENT HOOKUP ... 57 PATIENT DEMOGRAPHIC ENTRY ... 59 ECG ACQUISITION, PRINTING, STORAGE ... 60 ACQUIRING RHYTHM STRIPS... 62 SYSTEM SETTINGS ... 65 CONFIGURING USERS AND ROLES ... 65 CONFIGURATION MENUS... 69 SUMMARY OF CONFIGURATION MENUS ... 70 CONFIGURATION SETTINGS ... 73 ECG DIRECTORY ... 85 ECG ORDER LIST ... 86 CONNECTIVITY AND ECG TRANSMISSION ... 87 ECG TRANSMISSION ... 87 MODEM TRANSMISSION... 88 LAN TRANSMISSION ... 92 WLAN TRANSMISSION ... 94 GPRS MOBILE TRANSMISSION ... 95 ORDERS DOWNLOAD ... 96 CUSTOM ID DOWNLOAD ... 97 USB MEMORY ... 97 NETWORK TEST ... 99 NETWORK LOG FILE ... 99 MAINTENANCE AND TROUBLESHOOTING ... 101 SYSTEM TROUBLESHOOTING CHART ... 101 ECG TROUBLESHOOTING CHART ... 101 TRANSMISSION TROUBLESHOOTING CHART ... 101 POWER OFF THE DEVICE... 103 TEST OPERATION ... 103 RECOMMENDATIONS TO BIOMEDICAL STAFF ... 103 BATTERY MAINTENANCE ... 103 CLEANING THE THERMAL PRINTER ... 104

4

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.

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 150c or ELI 250c 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. If the unit is configured for a modem, this label is placed to the right of the product label. If the unit is configured for WLAN, this label is placed to the right of the product label. AM12 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. When the ELI 150c or ELI 250c is configured for the WAM, the UTK label is placed to the right of the product label and below the Modem or WLAN labels when present.

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.,

5

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.

6

WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC., (hereinafter referred to as “Welch Allyn”) hereby warrants that Welch Allyn products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Welch Allyn or an authorized distributor or representative of Welch Allyn. The warranty period is defined as twenty-four (24) months following the date of shipment from Welch Allyn. Normal use, service, and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions: a)

Freight damage;

b) Parts and/or accessories of the Product/s not obtained from or approved by 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. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, ELECTRODES, PATIENT CABLES, LEAD WIRES, AND MAGNETIC STORAGE MEDIUMS. 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 AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, 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. 7

WARRANTY INFORMATION

8

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 Welch Allyn 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.

•

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

•

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

•

Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrode, 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 cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

•

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. 9

10

USER SAFETY INFORMATION

•

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.

•

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 150c/ELI 250c 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 150c/ELI 250c 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 150c/ELI 250c 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 non- medical 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.

•

After defibrillation pulse, electrocardiograph has a maximum recovery time of 5 seconds.

•

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.

•

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.

USER SAFETY INFORMATION

•

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 Welch Allyn 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 GPRS module operates in allocated frequency bands depending on the model. Identification of the installed GPRS module can be found on a label on the bottom of the device. • MultiTech Systems, Inc. Model MTSMC-G-F4 (Quad Band): 850/900/1800/1900 MHz, user selectable

•

The WLAN identification can be found on a label on the bottom of the device. B&B electronics1 : Radio Module 9373 with part number WLNN-AN-MR551 1

Manufacturer also called B+B SmartWorx (model subject to change without notice)

•

Use of the GPRS or WLAN module may interfere with other equipment operating in the vicinity. Check with local authorities or spectrum management officials in your facility to determine if restrictions apply to the use of this feature in your area.

•

Do not transmit via the GPRS or 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 GPRS 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 GPRS and WLAN modules comply with applicable RF safety standards including standards and recommendations for the protection of public exposure to RF electromagnetic energy that have been established by governmental bodies and other qualified organizations, such as the following: • Federal Communications Commission (FCC) • Directives of the European Community • Directorate General V in Matters of Radio Frequency Electromagnetic Energy

•

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.

11

•

•

USER SAFETY INFORMATION

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 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.

Caution(s) •

To prevent possible damage to the keyboard, do not use sharp or hard objects to depress keys, only use fingertips.

•

Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to 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 Welch Allyn Service Department.

•

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

•

No calibration or 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.

•

Use only No. 26 AWG or larger telecommunication line cord.

Note(s)

12

•

Patient movements 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.

USER SAFETY INFORMATION

•

A square wave presentation on the display while using the WAM may be due to the WAM being turned off, having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the LED indicator on the WAM to ensure the unit is turned on, has proper battery level, is paired correctly, and is within recommended proximity of the electrocardiograph, or power cycle the WAM to recalibrate.

•

A square wave presentation on the display while using the AM12 may be due to improper autocalibration. Power cycle the AM12 or the electrocardiograph.

•

If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, display will indicate a lead fault for the lead(s) where the condition is present and if the signal is being printed, the respective lead(s) will print out as a square wave.

•

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: +10° to +40°C (+50° to +104°F) Operating humidity: 10% to 95% RH, noncondensing Storage temperature: Storage humidity: condensing

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

Atmospheric pressure:

500 hPa to 1060 hPa

•

WAM™ (wireless acquisition module) must be paired to electrocardiograph before operation.

•

Device must be configured at the factory for use with the WAM.

•

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.

•

The device is UL classified. WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-1-1, CAN/CSA C22.2 No. 606011-1-02, IEC60601-2-25 AND CAN/CSA C22.2 No. 601.2.25-94.

13

•

The device is a member of the ELI 1xx or ELI 2xx Series 2 electrocardiograph family.

USER SAFETY INFORMATION

Wireless Data Transmission •

14

Some Welch Allyn electrocardiographs can be equipped with an optional wireless data transmission module (WLAN or GPRS mobile). Both these technologies use 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 RF signals may propagate better and allow successful transmissions.

USER SAFETY INFORMATION

WLAN Option •

Wireless options transmit at 2.4 GHz. Other nearby wireless devices may cause interference. If possible, move or turn off other devices to minimize potential interference.

•

The following table shows the channels allocated in different geographic areas in the world. Please consult with your IT personnel in order to set the device on the proper channels. Specification

Description

Technology

IEEE 802.11 b/g, WiFi compliant 2.400 – 2.4835 GHz (U.S./CAN/Japan/Europe) 2.471 – 2.497 GHz (Japan) U.S.A./CANADA: 11 channels (1-11) Europe: 13 Channels (1-13) Japan: 14 Channels (1-14) +15dBm (typical) approx. 32 mW

Frequency Channels RF Power

•

The following table lists the frequency allocated for each channel used by the WLAN option. Channel

Center Frequency

Frequency Spread

1

2412 MHz

2399.5 MHz - 2424.5 MHz

2

2417 MHz

2404.5 MHz - 2429.5 MHz

3

2422 MHz

2409.5 MHz - 2434.5 MHz

4

2427 MHz

2414.5 MHz - 2439.5 MHz

5

2432 MHz

2419.5 MHz - 2444.5 MHz

6

2437 MHz

2424.5 MHz - 2449.5 MHz

7

2442 MHz

2429.5 MHz - 2454.5 MHz

8

2447 MHz

2434.5 MHz - 2459.5 MHz

9

2452 MHz

2439.5 MHz - 2464.5 MHz

10

2457 MHz

2444.5 MHz - 2469.5 MHz

11

2462 MHz

2449.5 MHz - 2474.5 MHz

12

2467 MHz

2454.5 MHz - 2479.5 MHz

13

2472 MHz

2459.5 MHz - 2484.5 MHz

14

2484 MHz

2471.5 MHz – 2496.5 MHz

•

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 the above situations, it is recommended to move the device to a proper location and verify with the IT personnel of the facility the areas where the WLAN signals are available.

15

USER SAFETY INFORMATION

16

EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation 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. 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. Alternating current Protective earth Telephone line (modem)

Network (LAN)

Defibrillator-proof type CF applied part

USB port

Input ON/OFF (power) Stop (of action) Shift key (to enter upper case text) Enter key (accept data/return) Initiate printing of 12-lead ECG Initiate printing of continuous rhythm strip Transmit, receive and time sync operation depending upon configuration settings

Do not dispose as unsorted municipal waste. Requires separate handling for waste disposal according to local requirements as per 2012/19/EU WEEE Antenna

17

EQUIPMENT SYMBOLS AND MARKINGS

Indicates compliance to applicable European Union directives

CE symbol

UL approved mark

Do not re-use, Single use device

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.

Medical Device

Reorder Number

Model Identifier

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

Manufacturer

Authorized representative in the European Community

Serial Number Global Trade Item Number

Lot number

18

Use by date

EQUIPMENT SYMBOLS AND MARKINGS

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

Australian Communications and Media Authority (ACMA) Radio Compliance Mark

KC Mark (South korea)

Radio approval symbol for Pakistan

Conatel Approval symbol for Paraguay

Eurasia Certification

19

Package Symbol Delineation

Keep away from sunlight

This way up

Fragile

Keep dry

Temperature limit

Humidity limitation

Atmospheric pressure limitation

Contains Non-spillable Battery

20

EQUIPMENT SYMBOLS AND MARKINGS