ELI 350 User Manual Rev J1

Copyright © 2012 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, E-Scribe, VERITAS, and WAM are trademarks of Mortara Instrument, Inc. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. V1.41.

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

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 Bonifaciusring 15 45309 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478 Mortara Dolby UK Ltd. Monitor House, Kerse Road Stirling FK7 7RZ Scotland Tel: +44.1786.446640 Fax: +44.1786.446630

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 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 twenty four (24) 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, 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 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. Contact Mortara 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 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.

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USER SAFETY INFORMATION

•

This device does not automatically switch between direct or wireless patient cables. Clinician must choose patient cable before ECG acquisition.

•

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.

•

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’) 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.

•

Some Mortara electrocardiographs can be equipped with a GSM (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: •

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The WLAN identification can be found on a label on the bottom of the device. • Quatech, Inc. Model WLNG-AN-DP101: 2400 MHz (model subject to change without notice)

USER SAFETY INFORMATION

•

Use of the GSM 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 GSM 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 GSM 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 GSM 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

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 Mortara Instrument 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 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.

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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.

•

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.

•

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 re-calibrate.

•

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: 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. This light will turn off when the battery is fully charged.

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USER SAFETY INFORMATION

•

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 UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, AND IEC60601-2-25

Wireless Data Transmission •

Some Mortara electrocardiographs can be equipped with an optional wireless data transmission module (WLAN or GSM). Both these technologies use radios to transmit data to a Mortara receiving application. Due to the nature of radio transmissions, it’s possible that, due to the characteristics of the environment where the device is located, some other RF sources may interfere with the transmission generated by the device. Mortara Instrument has tested the coexistence of the device with other devices that can interfere such as devices using WLAN, Bluetooth radio, and/or cell phones. Although the current technology allows a very successful rate of transmission, it’s possible that in some rare occurrences, the system may not perform at its best resulting in a “failed transmission”. When this occurs, patient data will not be erased from the device nor stored in the receiving application, ensuring that partial or corrupted data are not made available to the receiving station. If the failure mode persists the user should move to a position where the RF signals may propagate better and allow successful transmissions.

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

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USER SAFETY INFORMATION

•

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 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 Attention, consult accompanying documents

Alternating current

Protective earth Fuse

Telephone line (modem)

Network (LAN)

Universal Serial Bus (USB)

Defibrillator-proof type CF applied part

Output/Transmit

Input

ON/OFF (power)

Stop (of action)

×

Shift key (to enter upper case text)

Space key

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EQUIPMENT SYMBOLS AND MARKINGS

Enter key (accept data/return)

ECG

Initiate acquisition of ECG

RHY

Initiate printing of continuous rhythm strip

SYNC

Initiate transmission of records

STOP

Stop rhythm print out

Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements

Antenna

Indicates compliance to applicable European Union 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 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 Cable 1. 2. 3.

4. 5. 6.

Remove cables and lead wires from device before cleaning. For general cleaning of 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 cables and lead wires, 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 as recommended by the APIC Guidelines for Selection and Use of Disinfectants. 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: 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.

Cleaning the Device Disconnect the power source. Clean the exterior surface of the device with a damp, soft, lint-free cloth using a solution of mild detergent diluted in water. After washing, thoroughly dry off the device with a clean, soft cloth or paper towel.

Sterilization EtO sterilization is not recommended but may be required for cables and lead wires. Frequent sterilization will reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a maximum temperature of 50°C/122°F. After EtO sterilization, follow the recommendations from the sterilizer manufacturer for required aeration.

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.

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GENERAL CARE

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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 Table X-4 for recommended separation distances between the radio equipment and the device. The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the equipment.

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-1 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

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.

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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

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.

xvii

ELECTROMAGNETIC COMPATIBILITY (EMC)

Table 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.

xviii

TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose ... 1 Audience ... 1 Indications for Use ... 1 System Description ... 2 Figure 1-1, ELI 350, System Illustration ... 3 Figure 1-2, ELI 350, Side View ... 4 Figure 1-3, ELI 350, Rear View ... 4 Figure 1-4, ELI 350, Base View ... 5 Figure 1-5, ELI 350, Keyboard Touchpad ... 6 Figure 1-6, ELI 350, Keyboard Click Knob ... 7 Automatic Feature Keys ... 7 Display Overview ... 8 Navigation Overview... 9 ELI 350 Specifications ... 10 Accessories ... 11

EQUIPMENT PREPARATION SECTION 2 Connecting the Patient Cable ... 15 Loading Paper... 16 Applying Power ... 19 Setting Date and Time ... 20 Time Synchronization... 21 Installing the WLAN Antenna ... 21 Using the WAM Acquisition Module ... 21

RECORD AN ECG SECTION 3 Patient Preparation... 23 Patient Hookup ... 23 Patient Demographic Entry ... 27 Optional Bar Code Scanner ... 27 ECG Acquisition, Printing, Storage ... 28 Acquisition ... 28 ECG Selection from Full-disclosure ECG Buffer ... 29 Best 10 Seconds Selection ... 30 Printing ... 30 Pacemaker Presentation ... 30 Storage ... 30 Acquiring Rhythm Strips ... 31

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