RScribe User Manual Rev C1 May 2010

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. AM12, RScribe, WAM, XScribe, and X12+ are trademarks of Mortara Instrument, Inc. SCF (Source Consistency Filter) is a copyright of Mortara Instrument, Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation. Adobe and Acrobat are registered trademarks of Adobe Systems Incorporated. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. V5.10

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) Italia 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. Units 11 & 12, Scion House Stirling University Innovation Park Stirling FK9 4NF Scotland Tel: +44.1786.444980 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. Software equipment is accompanied by an identification card; carefully store this card as the information is needed for activation, upgrade and customer service. 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 there from 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, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, 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. Contact Mortara service for additional training options.

•

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 (9 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.

•

Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrodes, should not come into contact with other conductive parts including earth ground.

•

The device is part of an integral personal computer-based diagnostic system. The user must adhere to all warnings in order to ensure safe and reliable performance.

•

If operated on AC (~) power, the personal computer must be connected with its original power cable to an electrical installation that complies with applicable regulations for environments where patients are treated.

•

The personal computer used and any peripheral devices connected to it must be approved to the appropriate safety standard for nonmedical information technology equipment per IEC 60950, or its national variants.

•

The personal computer and any peripheral devices connected to it, being non-medical electrical equipment, must be situated outside the patient environment per IEC 60601-1–1. To ensure the safety of the patient it must not be possible for the operator to touch the patient and the computer at the same time. In general, at least 1.5 meters (5’) of open area must surround the patient to achieve this.

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USER SAFETY INFORMATION

•

If the personal computer is situated within the patient environment, ensure that its level of safety is that of medical electrical equipment per IEC 60601-1. This may be accomplished by powering the computer and any other equipment connected to it through an isolation transformer or by operating on battery power.

•

If the personal computer is situated within the patient environment, to maintain designed operator and patient safety when a LAN network connection is being used, the network cable must be connected to the device through an Ethernet isolator module that complies with IEC 60601-1-1 (available from Mortara Instrument).

•

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.

•

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. Do not mix electrodes made of dissimilar metals.

•

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.

•

A possible explosion hazard exists. Do not use the device in the presence of flammable anesthetic mixture.

•

Possible malfunction risks may be present when installing third-party software. Mortara Instrument, Inc. cannot verify the compatibility of all possible hardware/software combinations.

•

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 defibrillation and ultrasound machines.

•

When the software is installed on the XScribe™ Stress Exercise system, refer to the XScribe user manual for additional warnings.

Caution(s) •

Do not attempt to clean the 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.

•

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.

•

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.

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USER SAFETY INFORMATION

•

Windows compatibility, updates and anti-virus policy: The RScribe software has been fully tested with Windows 7 Professional Service Pack 1. The Modality Manager software has also been tested with Windows Server 2008 R2 Service Pack 1. Although it is unlikely that Windows updates and security patches affect RScribe functionality, Mortara recommends turning automatic Windows update off, and periodically running it manually. A functional test should be executed after update, which includes acquiring a recording, editing and printing a report, as well as importing an order and exporting results, if activated. Compatibility of RScribe with corporate anti-virus software packages has been evaluated. Mortara recommends excluding the RScribe database folder (Normally C:ProgramDataMiPgSqlData on a stand-alone system or the server) from the folders to be scanned. In addition, anti-virus patch updates and system scans should be scheduled for time periods when the system is not actively in use or performed manually.

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.

•

If an electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, the display will indicate a lead fault for the lead(s) where the condition is present.

•

As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows: - Type CF, defibrillation-proof applied parts. If not specifically indicated otherwise, personal computer equipment used with the device can be regarded as: - Class I (if the computer has a three-prong power inlet) or class II (if it has a two-prong inlet) - 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: Relative humidity: Atmospheric pressure:

•

-20° C to 65° C (-4° F to 149° F) 10% to 95%, non-condensing 500 hPa to 1060 hPa

Allow the device and any computer equipment used to stabilize within its intended operating environment for a minimum of two hours prior to use. Refer to the computer equipment user manual for allowable environmental conditions. The allowable environmental conditions for the AM12 and WAM acquisition modules are as follows: Ambient temperature: Relative humidity: Atmospheric pressure:

10° C to 40° C (50° F to 104° F) 10% to 95%, non-condensing 500 hPa to 1060 hPa

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USER SAFETY INFORMATION

viii

EQUPMENT SYMBOLS AND MARKINGS

Symbol Delineation Attention, consult accompanying documents Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements Indicates compliance to applicable European Union directives

NOTE: Refer to the manual(s) accompanying the device that pertain to the computer hardware for additional definitions of symbols that may be present.

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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, alcohol, 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 Cables 1. 2. 3.

4. 5. 6.

Remove cables and lead wires from device before cleaning, remove battery (WAM). 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. Consult computer and peripheral equipment user manual for specific instructions and precautions.

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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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.

xi

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.

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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.

xiv

TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose ... 1 Audience ... 1 Intended Use ... 1 Indications for Use ... 1 System Description ... 2 Installation Process ... 3 Feature Activation ... 5 Login and Main Display ... 6 Program Icons... 7 User Roles and Permissions ... 8 Specifications ... 10 Accessories ... 11 Support Parts ... 12

USING RSCRIBE SECTION 2 Real-time Display ... 13 Preview Acquisition Screen ... 13 Recording an ECG ... 14 Applying Anti-aliasing ... 14 Using the Acquisition Module... 15 Connecting the Acquisition Module ... 15

SCHEDULE/ORDERS SECTION 3 Time Filter ... 17 Group By Column Header ... 17 Schedule a New Order ... 18

RECORD AN ECG SECTION 4 Patient Preparation... 21 Patient Hookup ... 21 Patient Demographic Entry ... 23 ECG Acquisition, Printing, Storage ... 24 Display Overview ... 24 Acquire ECGs... 26 Manual ECG Capture ... 26 Best 10 Seconds Selection... 26 Capturing ECGs from the Full Disclosure Buffer ... 27 Timed ECG Recording ... 27 Captured ECG Display ... 27 Printing ... 28 Storage ... 28

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TABLE OF CONTENTS

CONTEXT MENUS SECTION 5 Context Menu Settings ... 29

REVIEW ECGS SECTION 6 Selecting Reports to Review... 35 Status Filter ... 35 Time Filter ... 35 Group by Column Header ... 35 Edit a Resting ECG Report ... 36 Confirm and Sign the Report ... 39 Report Print Preview ... 40 Icon Tool Bar... 40 Sections ... 40

EXAM SEARCH SECTION 7 Filters and Identifiers ... 41 Group by Column Header ... 42 Offline Exam Copies ... 42

PATIENT SEARCH SECTION 8 Filters and Identifiers ... 43 Group by Column Header ... 44 Add a New Patient ... 44 Delete a Patient ... 44 Duplicate Patient ID ... 45 Patient and Exam Reconciliation ... 45

SYSTEM SETTINGS SECTION 9 User’s Database ... 47 Personnel ... 47 Storage System ... 48 Audit Trail ... 48 Service Logs ... 49 Manage/Create Groups ... 49 Configure Workflow ... 49 Unlock Exams ... 50 Modality Settings... 51 Waveforms Tab ... 51 Acquire Tab ... 53 Full Disclosure Tab ... 54 Resting ECG Tab ... 55 Acronyms Tab ... 57 File Exchange Configurations ... 57 Accessing the User Preferences Screen ... 58 Report Configuration Tool ... 59

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INTRODUCTION SECTION 1

Manual Purpose This manual is intended to provide the user with information about the RScribe™ resting electrocardiograph’s display screen, menu structure, icons, and navigation tools pertaining in the following section: • • • • • • • •

Using RScribe. (Section 2) Using Schedule/Orders. (Section 3) Recording an ECG. (Section 4) Context menus. (Section 5) Reviewing ECGs. (Section 6) Using Exam Search. (Section 7) Using Patient Search. (Section 8) System Settings. (Section 9) NOTE: This manual contains screen images that are for illustration, and might be different in the actual product. Consult the actual screen in the host language for specific wording.

Audience This manual is written for clinical professionals with a working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

Intended Use The RScribe electrocardiograph is a personal computer-based, 12-channel diagnostic electrocardiograph used for acquiring, analyzing, displaying, recoding and printing resting ECG’s for adult and pediatric patients. The acquired ECG will be displayed for quality review purpose and analyzed using the Mortara VERITAS resting interpretation algorithm (Option). Data can be printed, stored and/or transmitted to a ECG Management System or Hospital Information System. The device is not intended for use as a vital signs physiological monitor.

Indications for Use The RScribe electrocardiograph is a non-invasive prescription device. • The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms. • The device is indicated for use to provide interpretation of the data for consideration by a physician. • The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • 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. • The device is indicated for use on adult and pediatric populations. • 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.

1

SECTION 1

System Description RScribe is a multi-lead, diagnostic, computer-based resting electrocardiograph capable of acquiring, viewing, transmitting, printing, and storing ECG data. RScribe models ordered with the VERITAS™ resting ECG interpretation algorithm option are capable of specific age and gender interpretation criteria. The VERITAS algorithm provides an over-reading physician with a silent second opinion through diagnostic statements displayed on the ECG report. For additional information on the VERITAS algorithm, please refer to the Physician’s Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation (see Accessories). RScribe can be configured with bidirectional connectivity and DICOM® protocol support. RScribe is integrated with a multi-modality patient and exam management system called Modality Manager. Modality Manager handles the scheduling of exams, database storage and maintenance, exam and patient search, printing, communication with external systems and dispatches the modality dependent acquisition and review functions. RScribe can be configured for data distribution. When so configured, the database resides on a server supporting a number of networked client workstations. The RScribe Review software offers authorized users with the ability to schedule new exams when not linked to an external scheduling system, view reports, enter conclusions, and generate printed or electronic reports for completed exams. The RScribe supports print formats that include: • Standard or Cabrera 3, • 3+1, • 3+3, • 12, • 6+6 channel in automatic mode; • Single channel on one page (60 min of acquired ECG for rhythm strip (Full Disclosure) printing. The RScribe packing list includes: • Acquisition module with lead wire set • Software CD • Physician’s Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation • User manual CD • Accessory starter kit

2

SECTION 1

Installation Process Navigate to the location of the software to be installed and double click on the “Setup” application file. If asked, allow the program to make changes to the computer by clicking Yes. The Setup wizard window should appear, click next to continue. NOTE: If you are upgrading the system from a previous version, the next step will be omitted. Select the appropriate Setup Type for the installation (see below): There are 5 installation choices. Select the one that simplifies the installation process. The definitions below will assist with making the most appropriate choice. Standard: Chose the standard option if you are loading a single modality with the Database Server functionality included on a single computer. NOTE: Choose the Standard option when loading XScribe and RScribe with the Database Server functionality onto a single computer. Review: Choose this option when loading all modality clients ONLY onto a computer, with the Database Server functionality already loaded onto a separate networked computer. This option is meant for multi-modality review stations. Download: Choose this option ONLY when loading RScribe V5.0 Download Station onto a computer; and the Database Server functionality already loaded onto a separate networked computer. Demo: This option should be used to load a single computer with all modalities and the Database Server functionality onto a single computer for demonstration purposes. NOTE: The Demo mode does NOT allow importing or acquisition of data. It ONLY operates with demonstration data, included when the software is loaded. Advanced: This option should be used for all cases that do not fit into one of the categories above. This option allows the installer to select an alternate path to install the software. It also allows for installations using multiple networked computers with the Database Server functionality loaded onto a separate computer or a Server hardware platform.

3