User Manual
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Welch Allyn® ELI® 280 RESTING ELECTROCARDIOGRAPH
SERVICE MANUAL
Manufactured by Welch Allyn, Inc. Skaneateles Falls, NY U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician
© 2019 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 V2.4.1
For patent information, please visit www.welchallyn.com/patents For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html 1.888.667.8272, [email protected]
9516-181-50-ENG Rev G (also refer to TDR footers for revision updates) Revision date: 2021-01 901132 ELECTROCARDIOGRAPH
Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallyn.com
TABLE OF CONTENTS NOTICES ... 3 MANUFACTURER’S RESPONSIBILITY ...3 RESPONSIBILITY OF THE CUSTOMER ...3 EQUIPMENT IDENTIFICATION ...3 COPYRIGHT AND TRADEMARK NOTICES ...3 OTHER IMPORTANT INFORMATION...3 WARRANTY INFORMATION ... 4 YOUR WELCH ALLYN WARRANTY...4 USER SAFETY INFORMATION ... 5 WARNING(S) ...5 CAUTION(S) ...7 NOTE(S) ...8 EQUIPMENT SYMBOLS AND MARKINGS ... 11 SYMBOL DELINEATION ...11 SYSTEM SETTINGS ... 13 PRECAUTIONS ...13 INSPECTION ...13 CLEANING EXTERIOR SURFACES AND PATIENT ACQUISITION DEVICE...13 ELECTROMAGNETIC COMPATIBILITY (EMC) ... 14 SYSTEM SETTINGS ... 18 MENU COMMANDS AND UTILITIES ...19 SECURITY ...21 CONFIGURATION SETTINGS: ABOUT ...22 CONFIGURATION SETTINGS: MODEM ...23 CONFIGURATION SETTINGS: SYSTEM ...24 CONFIGURATION SETTINGS: ECG ...27 CONFIGURATION SETTINGS: LAN ...31 CONFIGURATION SETTINGS: DATE/TIME ...34 PREVENTIVE MAINTENANCE ... 35 RECOMMENDED TOOLS AND SUPPLIES ...35 PREVENTIVE MAINTENANCE PROCEDURE ...36 DEVICE TESTING ...37 CALIBRATION ...39 DEVICE CLEANING ...40 SAFETY TESTING ...41 ELI 280 PREVENTIVE MAINTENANCE REPORT ...42 SEALED LEAD-ACID BATTERY PERFORMANCE INFORMATION ...43 UNIT DISASSEMBLY ... 45 BATTERY REMOVAL ...46 UPPER HOUSING REMOVAL ...47 THERMAL WRITER REMOVAL ...49 MOTHERBOARD REMOVAL ...51
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TABLE OF CONTENTS
ELI 280 UPPER HOUSING AND TOUCH SCREEN ASSEMBLY REMOVAL ...52 TOUCH SCREEN CONTROLLER PCA REMOVAL ...53 THERMAL WRITER DISASSEMBLY ...60 GEARBOX AND MOTOR ...67 CUE SENSOR REPLACEMENT...68 PRINTHEAD REPLACEMENT ...69 ELI 280 WRITER A4/SMART PAPER SPACER ...70 ORDER OF REASSEMBLY ...77 CONFORMANCE TESTING ... 81 POWER TESTING ...81 FUNCTIONAL TESTING...82 ELI 280 TEST DATA RECORD ...86 TROUBLESHOOTING... 87 ECG TROUBLESHOOTING CHART ...87 ECG ELECTRODE PLACEMENT TROUBLESHOOTING ...87 PATIENT CABLE TROUBLESHOOTING CHART ...88 ECG TRANSMISSION TROUBLESHOOTING CHART ...90 THERNET TRANSMISSION STATUS INDICATOR LEDS ... 91 DISPLAY TROUBLESHOOTING CHART ...91 PRINTER TROUBLESHOOTING CHART ...92 SPECIAL FUNCTIONS ... 93 TIME SYNC ...93 TESTING THE WLAN/LAN SETTINGS...93 CUE SENSOR CALIBRATION ...93 AUTO TEST ...93 CHANGE THE DEVICE OWNER’S NAME ...94 COPY LOG FILES TO A USB FLASH DRIVE ...94 COPY ALL ECG RECORDS TO A USB FLASH DRIVE ...94 ERASE ALL ECG RECORDS ...94 WRITER TEST ...94 TEST CONFIGURATION* ...95 CLEAR FLAGS ...95 FILL DIRECTORY ...95 FIRMWARE ...95 CONFIG FILE ...95 OPTIONS FILE...95 FIRST TIME BOOT ...96 IIR ON ...96 COMMUNICATION OPTIONS ... 97 COMMUNICATION OPTION INSTALLATION/UPGRADES ...97
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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.
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.
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 Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.
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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 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.
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USER SAFETY INFORMATION WARNING:
Means there is the possibility of personal injury to you or others.
Caution:
Means there is the possibility of damage to the device.
Note:
Provides information to further assist in the use of the device.
NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording.
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.
To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, and IEC 60601-2-25. Only use parts and accessories supplied with the device and available through Welch Allyn, Inc.
Patient acquisition devices intended for use with the device include series resistance (9 Kohm minimum) in each lead for defibrillation protection. Patient acquisition devices should be checked for cracks or breakage prior to use.
Conductive parts of the Patient acquisition device, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the Patient acquisition device and electrodes, should not come into contact with other conductive parts including earth ground.
ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with device or Patient acquisition devices. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.
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USER SAFETY INFORMATION
This device does not automatically switch between direct or wireless Patient acquisition devices. Clinician must choose Patient acquisition device before ECG acquisition. If your device is equipped with a receiver for a wireless Patient acquisition device, always make sure that you are receiving data from the expected module.
This device was designed to use the electrodes specified in the user manual. Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions. Electrodes are intended for short-term use and should be removed from the patient promptly following testing.
To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
To ensure the safety of both the patient and the device, 1.5 meters (5 feet) of open area should surround the patient.
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.
All signal input and output (I/O) connectors are intended for connection of only those devices complying with IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the device. Connecting additional devices to the device may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured to confirm no electric shock hazard exists.
To improve immunity to potential interfering electromagnetic signals, shielded cabling is recommended when connecting the device to a network.
To maintain operator and patient safety, equipment connected to the same network as the device must meet the requirements of IEC 60950 or IEC 60601-1.
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.
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.
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USER SAFETY INFORMATION
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 WLAN identification can be found on a label on the bottom of the device. Quatech, Inc. Model WLNG-AN-MR551: 2400 MHz (model subject to change without notice)
Use of the WLAN module may interfere with other equipment operating in the vicinity. Check with local authorities or spectrum management officials in your facility to determine if restrictions apply to the use of this feature in your area.
●
Do not transmit via the WLAN module with a missing or damaged antenna. Replace a damaged antenna immediately.
Use only the antenna supplied for use with this device. Unauthorized antennas, modifications, or attachments could damage the WLAN module and may contravene local RF emission regulations or invalidate type approval.
To ensure compliance with current regulations limiting both maximum RF output power and human exposure to radio frequency radiation, a separation distance of at least 20 cm must be maintained between the device's antenna and the head and body of the user and any nearby persons at all times. To help prevent degradation of RF signal and to avoid excess RF energy absorption, do not touch the antenna during data transmission.
The WLAN module complies with applicable RF safety standards including standards and recommendations for the protection of public exposure to RF electromagnetic energy that have been established by governmental bodies and other qualified organizations, such as the following: Federal Communications Commission (FCC) Directives of the European Community Directorate General V in Matters of Radio Frequency Electromagnetic Energy
Caution(s)
To prevent possible damage to the touchscreen, do not use sharp objects to touch the screen icons, only use fingertips.
Do not attempt to clean the device or patient acquisition device by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the device.
No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use.
The rechargeable internal battery is a sealed lead-acid type and it is totally maintenance free. If the battery appears to become defective, refer to Welch Allyn Service Department.
Do not pull or stretch patient acquisition device as this could result in mechanical and/or electrical failures. Patient cables should be stored after forming them into a loose loop.
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USER SAFETY INFORMATION
Calibration of the display is required before initial operation of the unit. No special equipment is needed for the proper operation or maintenance of the device.
When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations.
Proper functioning backup items such as a spare patient cable, front-end device, display monitor, and other equipment are recommended on hand to prevent delayed treatment due to an inoperable device.
Note(s)
Patient movement may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device.
Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and tries to identify the most likely switch; however, it is advisable to check the other electrode positions in the same group (limb or chest).
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the device; however, disturbance to the signal may occur.
If a thick baseline is presented on the display while using the WAM (square waves on rhythm printout), this may be due to the WAM being turned off, has no battery, is out of range or has experienced a calibration error. Review the LED indicator on the WAM to assure the unit is turned on, has proper battery level, assure the WAM is paired correctly and is within recommended proximity of the electrocardiograph or power cycle the WAM to re-calibrate. Review the WAM user manual for details.
If a thick baseline is presented on the display while using the AM12 (square waves on rhythm printout), this may be due to an improper auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.
If a square wave is presented on the display and rhythm printout this may be due to the WAM, AM12 or some lead wires not being connected to a patient.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows: Class I equipment or internally powered. Type CF defibrillation-proof applied parts. Ordinary equipment. Equipment not suitable for use in the presence of a flammable anesthetic mixture. Continuous operation. NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this device is declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with mains. The ground terminal on the mains inlet is the only protective earth point in the device. Exposed metal accessible during normal operation is double insulated from mains. Internal connections to earth ground are functional earth.
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USER SAFETY INFORMATION
This device is intended to be used in a hospital or doctor’s office setting, and should be used and stored according to the environmental conditions specified below: Operating temperature: Operating humidity:
+10° to +40°C (+50° to +104°F) 10% to 95% RH, non-condensing
Storage temperature: Storage humidity:
-40° to +70°C (-40° to +158°F) 10% to 95% RH, non-condensing
Atmospheric pressure:
500 hPa to 1060 hPa
The device will automatically turn off (blank screen) if the batteries have been severely discharged and the AC mains is disconnected from the device.
After operating the device using battery power, always reconnect the power cord. This ensures that the batteries will be automatically recharged for the next time you use the device. A light next to the on/off switch will illuminate indicating that the device is charging.
WAM (wireless acquisition module) must be paired to electrocardiograph before operation.
The device must be configured at the factory for use with the WAM.
The device is UL classified: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC 60601-1, CAN/CSA C22.2 No. 60601-1, AND IEC 60601-2-25
Wireless Data Transmission
Some Welch Allyn electrocardiographs can be equipped with an optional wireless data transmission module (WLAN or GSM). 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.
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USER SAFETY INFORMATION
WLAN Option
Wireless options transmit in the 2.4 GHz and 5 GHz range. Other nearby wireless devices may cause interference. If possible, move or turn off other devices to minimize potential interference.
The Wireless LAN module used is compliant with the IEEE 802.11 a, b, g and n standards.
Access Points used should respect IEEE 802.11 standards as well as local Radio Frequency regulations. The device will scan the available channels and connect to the Access Point on the channel where the SSID that is configured on the device is available.
The following table shows the radio channels allocated in different geographic areas in the world. For bands 802.11b and g, only channels 1, 6, 11 and 14 (Japan only) are non-overlapping; for band 802-11a, channels shown represent non-overlapping channel numbers. Band
802.11b
802.11g
802.11a
Typical Power 15 dBm / 32 mW
13 dBm / 18 mW
17 dBm / 50 mW
Region USA / Canada Europe
Frequency Range (GHz) 2.401 - 2.473
No. of channels 11
Channel numbers 1 – 11
2.401 - 2.483
13
1 – 13
Japan
2.401 - 2.495
14
1 – 14
USA / Canada Europe
2.401 - 2.473
11
1 – 11
2.401 - 2.483
13
1 – 13
Japan
2.401 - 2.483
13
USA / Canada Europe
5.15 - 5.35, 5.725 - 5.825 5.15 - 5.35, 5.47 - 5.725 4.91 – 4.99, 5.15 - 5.35, 5.47 - 5.725 5.725 - 5.825
13
1 – 13 36,40,44,48,52,56,60,64,149,153,157, 161,165 36,40,44,48,52,56,60,64,100,104,108, 112,116,120,124,128,132,136,140 36,40,44,48,52,56,60,64,100,104,108, 112,116,120,124,128,132,136,140,184 188,192,196 149,153,157,161,165
Japan
China
19 23
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In order to achieve the best transmission rate, it is necessary that the facility where the device is operated can provide good area coverage. Please consult the IT personnel of the facility to verify the proper WLAN availability in the area where the device will be used.
RF wave propagation may be blocked or reduced by the environment where the device is used. Most common areas where this may occur are: shielded rooms, elevators, underground rooms. In all such situations it is recommended to move the device to a proper location and verify with the IT personnel of the facility the areas where the WLAN signals are available.
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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 gray background in a black and white document. Alternating current
Protective earth symbol (appears on inside of unit)
Fuse symbol (appears on inside of unit)
Telephone line (modem)
Network (LAN)
Universal Serial Bus (USB)
Defibrillator-proof type CF applied part
Input
ON/OFF (power)
Shift key (to enter upper case text on keyboard)
Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements
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EQUIPMENT SYMBOLS AND MARKINGS
Antenna
Indicates compliance to applicable European Union directives
Initiate acquisition of ECG
Initiate printing of continuous rhythm strip
Initiate transmission of records
Stop rhythm print out
Configuration (Settings) menu
Home (returns user to the real-time acquisition screen)
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SYSTEM SETTINGS Precautions
Turn off the device before inspecting or cleaning. Do not immerse the device in water. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces.
Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs. Verify that all cords and connectors are securely seated. Check the case and chassis for any visible damage. Inspect cords and connectors for any visible damage. Inspect keys and controls for proper function and appearance.
Cleaning Exterior Surfaces and Patient Acquisition Device 1. 2. 3.
4. 5. 6. 7.
Remove cables and lead wires from device before cleaning. Disconnect the power source. For general cleaning of device, display, cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild soap and water solution. Wipe and air dry. For disinfecting the device, wipe exterior with a soft, lint-free cloth using 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, or a 3% hydrogen peroxide solution. For disinfecting the cables and lead wires, wipe exterior with a soft, lint-free cloth using the same solutions as for the device, or use highly concentrated (> 70%) isopropanol or ethanol. Use caution with excess liquid as contact with metal parts may cause corrosion. Do not immerse cable ends or lead wires; immersion can cause metal corrosion. Do not use excessive drying techniques such as forced heat.
WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning. Never expose cables to strong ultra-violet radiation. Do not sterilize the device or ECG lead wires with Ethylene Oxide (EtO) gas.
WARNING: Use of unspecified cleaning/disinfecting agents or failure to follow recommended procedures could result in increased risk of harm to users, patients and bystanders, or damage to the device. NOTE: Welch Allyn does not endorse any specific off-the-shelf wipes or liquids. However, products that only contain the disinfecting agents mentioned above are likely to be compatible with the device. Some products contain a mixture of agents and may have a detrimental effect if used intensively and frequently. Check the Material Safety Data Sheet of the product used for the list of ingredients.
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ELECTROMAGNETIC COMPATIBILITY (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using the device. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device according to the international standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2). The device should not be used adjacent to, or stacked on top of other equipment. If the device must be used adjacent to or stacked on top of other equipment, verify that the device operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See the appropriate EMC table for recommended separation distances between the radio equipment and the device. The use of accessories, transducers, and cables other than those specified by Welch Allyn may result in increased emissions or decreased immunity of the equipment.
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ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions CISPR 11
Group 1
The equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class A
Harmonic Emissions IEC 61000-3-2
Complies
The equipment is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test
Compliance
Compliance Level
Electromagnetic Environment: Guidance
Electrostatic discharge (ESD) IEC 61000-4-2
+/- 6 kV contact +/- 8 kV air
+/- 6 kV contact +/- 8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4
+/- 2 kV for power supply lines +/- 1 kV for input/output lines
+/- 2 kV for power supply lines +/- 1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
+/- 1 kV differential mode +/- 2 kV common mode
+/- 1 kV differential mode +/- 2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles
Mains power quality should be that of a typical commercial or hospital environment.
Power frequency (50/60 Hz) magnetic field
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.
15
ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 .5 d P 3Vrms
3 .5 d P 3V / m
80 MHz to 800 MHz
7 d P 3V / m
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m
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ELECTROMAGNETIC COMPATIBILITY (EMC)
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter W
Separation Distance According to Frequency of Transmitter (m)
150 KHz to 800 MHz
800 MHz to 2.5 GHz
d 1.2 P
d 2.3 P
0.01
0.1 m
0.2 m
0.1
0.4 m
0.7 m
1
1.2 m
2.3 m
10
4.0 m
7.0 m
100
12.0 m
23.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects, and people
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SYSTEM SETTINGS Specifications Feature
Specifications
Instrument Type
Multi-lead electrocardiograph
Input Channels
Simultaneous acquisition of all 12 leads
Standard Leads Acquired
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Waveform Display
Backlit, 10.1” high-resolution color LCD
Input Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection
Meets or exceeds the requirements of ANSI/AAMI EC11
Patient Leakage Current Chassis Leakage Current
Meets or exceeds the requirements of ANSI/AAMI ES1
Digital Sampling Rate
40,000 s/sec/channel used for pacemaker spike detection; 1000 s/sec/channel used for recording and analysis
Optional Functions
Welch Allyn VERITAS resting ECG interpretation algorithm with age and gender specific criteria; connectivity with bidirectional communication;
Paper
Perforated Z-fold thermal paper, Smart paper, A4 or 8.5 x 11” wide, 250 sheets
Thermal Printer
Computer-controlled dot array; 1 dot/ms horizontal, 8 dots/mm vertical
Thermal Printer Speeds
5, 10, 25, or 50 mm/s
Gain Settings
5, 10, or 20 mm/mV
Report Print Formats
Standard or Cabrera: 3+1, 3+3, 6, 6+6, or 12 channel
Rhythm Print Formats
3, 6, 8 or 12 channel with configurable lead groups
Frequency Response
0.05 to 300 Hz
Filters
High-performance baseline filter; AC interference filter 50/60 Hz; lowpass filters 40 Hz, 150 Hz, or 300 Hz
A/D Conversion
20 bits (1.17 microvolt LSB)
Device Classification
Class I, Type CF defibrillation-proof applied parts
ECG Storage
Internal storage up to 40 ECGs; optional expanded up to 200 ECGs
Weight
12.5 lbs. (5.68 kg) including battery (without paper)
Dimensions
17.5 x 15.5 x 4.5” (44.45 x 39.37 x 11.43 cm)
Power Requirements
Universal AC power supply (100-240 VAC at 50/60 Hz) 110 VA; internal rechargeable battery
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