ELI PC User Manual Rev A1

Copyright © 2010 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. ELI and WAM are trademarks of Mortara Instrument, Inc. Adobe, Acrobat, Microsoft, and Windows are trademarks or registered trademarks of their respective owners. V1.00

TECHNICAL SUPPORT AND SERVICE

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

European Union Representative Mortara Rangoni Europe, Srl (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument Germany Kaninenberghöhe 50 45136 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Randweg 4 5683 CL Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Unit 11, 7 Inglewood Place Baulkham Hills NSW 2153 Australia Tel: +61 2 8824 5499 Fax: +61 2 8814 5399

24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

i

NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance only if: •

Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons authorized by Mortara Instrument, Inc.

•

The electrical installation of the relevant room complies with the requirements of appropriate regulations, and

•

The device is used in accordance with the instructions for use.

Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.

ii

WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara 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 Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment from Mortara. 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 Mortara; c)

Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;

d) Accident; a disaster affecting the Product/s; e)

Alterations and/or modifications to the Product/s not authorized by Mortara;

f)

Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, 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 MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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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.

•

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 Mortara Instrument, Inc.

•

Patient cables intended for use with the device include series resistance (7 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 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 cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

•

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.

•

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.

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USER SAFETY INFORMATION

●

FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device.

•

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.

•

The computer used for the ELI PC application should conform to international safety standards for information technology equipment such as IEC 90950. Unless suitable electrical safety measures are taken, as indicated in IEC 60601-1-1, the computer must not be in a position such that the operator can touch it and the patient at the same time while taking the ECG.

•

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.

•

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.

•

Operations may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment.

•

The ELI PC application is used in conjunction with the Mortara Instrument Wireless Acquisition Module with Memory (WAM PC). This manual gives important information about the use and safety of the WAM PC device and ELI PC application. 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.

•

Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.

•

Low battery warning function is designed for alkaline battery cells only. Use of other cells may result in failure of the low battery warning possibly resulting in a malfunction of the device.

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USER SAFETY INFORMATION

Caution(s) •

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 surface 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.

•

The device and lead wires should be cleaned between each use. Inspect connections for damage or excessive wear prior to each use. Replace lead wires if damage or excessive wear is noted.

•

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

•

The WAM PC will only work with the Mortara UTK receiving devices that is equipped with the appropriate software.

•

No user-serviceable parts are 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.

•

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.

•

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

•

No calibration or special equipments are 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.

•

AA batteries are known to leak their contents when stored in unused equipment. Remove battery from device when not used for an extended period of time.

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USER SAFETY INFORMATION

FCC Compliance Statement In the United States use of this device is regulated by the Federal Communications Commission (FCC). The device with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure. FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device. WAM PC FCC ID: HJR-WAM2500 UTK FCC ID: HJR-UTK2500 These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation.

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

3758B-WAM2500 3758B-UTK2500

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

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USER SAFETY INFORMATION

Note(s) •

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.

•

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 (WAM PC) is classified as follows: • Internally powered equipment. • Type CF defibrillation-proof applied parts. • Ordinary equipment. • Equipment not suitable for use in the presence of a flammable anesthetic mixture. • Continuous operation. •

To prevent possible damage to the device during transport and storage (while in original packaging) the following environmental conditions must be adhered to: Ambient Temperature Range: Relative Humidity Range: Atmosphere Pressure:

●

-20°C to 65°C (-4°F to 149°F) 5% to 95% (non-condensing) 500 hPa to 1060 hPa

This device is intended to be used in a hospital or doctor’s office setting, and should be used according to the environmental conditions specified below: Ambient Temperature Range: Relative Humidity Range: Atmosphere Pressure:

0°C to 40°C (32°F to 104°F) 5% to 95% (non-condensing) 500 hPa to 1060 hPa

•

The device will automatically turn off if the battery has been depleted.

•

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

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USER SAFETY INFORMATION

Wireless Data Transmission •

x

The device is equipped with a wireless data transmission module. This technology uses radios to transmit data to a Mortara receiving application. Due to the nature of radio transmissions, it is possible that, due to the characteristics of the environment where the device is located, some other RF sources may interfere with the transmission generated by the device. Mortara Instrument has tested the coexistence of the device with other devices that can interfere such as devices using WLAN, Bluetooth radio, and/or cell phones. Although the current technology allows a very successful rate of transmission, it is 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, such as in close proximity to the receiver.

EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents

Defibrillator-proof type CF applied part

Acquire 12 Lead ECG

On / Off button

Battery with notification: See operating instructions for type of cell to be used Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements

Indicates compliance to applicable EEC directives

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GENERAL CARE Precautions • • •

Turn off the device before inspecting or cleaning. Do not immerse the device in water. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces.

Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs. • Verify that all cables 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 Disinfection Refer to section 4 for proper cleaning and disinfection procedures.

Sterilization EtO sterilization is prohibited by regulation for this device.

Test Operation After cleaning and inspecting the device, proper operation of the unit may be confirmed by using an ECG simulator to acquire, display, and print a standard 12-lead ECG of known amplitude using a test protocol. Waveforms should appear normal with proper amplitude and without distortion or excess noise. There is no need to submit the test ECG to the Clinical Information Server.

Cautions Improper cleaning products and processes can damage the device, produce brittle lead wires and cables, corrode the metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining the device. 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 WAM PC and UTK devices together with a representative receiver unit 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 Table X-4 for recommended separation distances between the radio equipment and the device. The use of accessories and cables other than those specified below, may result in increased emissions or decreased immunity of the device.

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ELECTROMAGNETIC COMPATIBILITY (EMC) NOTE: This section applies to the WAM PC and the UTK devices when connected to a computer. This section does not apply to the computer alone. 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 Table X-4 for recommended separation distances between the radio equipment and the device. The use of accessories and cables other than those specified below, may result in increased emissions or decreased immunity of the device.

Part Number

Description

9293-046-60 9293-046-61 9293-046-62 9293-046-63 9293-046-64 9293-046-65 9293-046-66 9293-046-67 9293-047-60 9293-047-61 9293-047-62 9293-047-63 9293-047-64 9293-047-65 9293-047-66 9293-047-67

LEAD SET WAM 10 WIRE BANANA AHA GRAY LEAD SET WAM 10 WIRE BANANA IEC GRAY REPLACEMENT LEAD SET WAM LIMBS BANANA AHA GRAY REPLACEMENT LEAD SET WAM LIMBS BANANA IEC GRAY REPLACEMENT LEAD SET WAM V1-V3 BANANA AHA GRAY REPLACEMENT LEAD SET WAM C1-C3 BANANA IEC GRAY REPLACEMENT LEAD SET WAM V4-V6 BANANA AHA GRAY REPLACEMENT LEAD SET WAM C4-C6 BANANA IEC GRAY LEAD SET WAM 10 WIRE CLIPS AHA GRAY LEAD SET WAM 10 WIRE CLIPS IEC GRAY REPLACEMENT LEAD SET WAM LIMBS CLIPS AHA GRAY REPLACEMENT LEAD SET WAM LIMBS CLIPS IEC GRAY REPLACEMENT LEAD SET WAM V1-V3 CLIPS AHA GRAY REPLACEMENT LEAD SET WAM C1-C3 CLIPS IEC GRAY REPLACEMENT LEAD SET WAM V4-V6 CLIPS AHA GRAY REPLACEMENT LEAD SET WAM C4-C6 CLIPS IEC GRAY

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-1 Guidance and Manufacturer’s Declaration: Electromagentic 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 2

The equipment must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

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 establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Complies

Table X-2 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.

xiv

ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-3 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

Electromagentic 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)

Tabel X-4 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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TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose ...1 Audience...1 Indications for Use ...1 System Description...2 ELI PC Application Installation ...3 ELI PC Application Login...4 WAM PC with Lead Wires ...5 Part Numbers ...6 Approved Battery Models ...7 Specifications ...8

USING ELI PC SECTION 2 Launching the Application ...9 Info and Settings Tab...10 Clear Device...11 Pair Devices ...11 Set Mains Frequency...11 Retrieve Logs ...11 Subject List Tab...12 Subject Visit Form ...13 Transfer to Device...15 Upload ECG from Device ...22 Submit Locally Saved Unsent ECGs...23 Manage Sent ECGs...24

USING THE WAM PC SECTION 3 Battery Installation ...25 Attaching the Lead Wire Connector Blocks...25 Turning the WAM PC On ...25 Turning the WAM PC Off...25 Pairing a WAM PC to an ELI PC...25 Patient ECG Hookup ...26 Positioning the Electrodes for 10-wire Hookup ...27 LED Display Battery Voltage Indicator ...28 Using the Buttons ...28 LED and Audio Indicators...29 Executing an ECG Acquisition Session ...30 Start Upload of an ECG stored on the WAM PC ...30

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TABLE OF CONTENTS

WAM PC MAINTENANCE SECTION 4 Cleaning the WAM PC and ECG Lead Wires ...31 Periodic Maintenance ...31 Disposal of Waste Materials...31

MESSAGES AND INFORMATION APPENDIX A System Information Log...33 Serial and Part Number Location ...33

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INTRODUCTION SECTION 1

Manual Purpose This manual is intended to provide the user with information about: • • • • •

Installing, using and understanding the ELI ™ PC application Powering the WAM™ PC on and off The WAM PC LED indicators How to initiate a 12-lead ECG acquisition session Maintenance of the WAM PC

Audience This manual is written for clinical professionals who are expected to have a working knowledge of medical procedures and terminology as required for acquiring clinical data from cardiac patients.

Indications for Use The WAM PC together with the ELI PC electrocardiograph application is a non-invasive prescription device: • • • • •

• • • •

Indicated for use to acquire, analyze, display and print electrocardiograms. The device is indicated for use for patients of any age, diseased or non-diseased. The device is indicated for use to provide interpretation of the data for consideration by a physician. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. Indicated for use in a clinical setting, by qualified medical professionals, properly trained for acquiring ECG data and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis. The device is not intended to be used as a vital signs physiological monitor. The device is not designed for out of hospital transport. The device is not designed for use in highly invasive environments, such as an operating theatre. The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

1