MAC 2000 Operators Manual Rev L

Publication Information The information in this manual applies only to MAC™ 2000. This applies to software version 1.1 and not to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. MUSE, MAC, CASE/CardioSoft/CS, 12SL, and EMR are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners. This program uses the SOA4D DPWSCore (C DPWS toolkit) library, © 2004–2010 Schneider Electric SA, licensed under the BSD License. Part of the software embedded in this product is gSOAP software. Portions created by gSOAP are Copyright © 2001-2004 Robert A. van Engelen, Genivia Inc. All Rights Reserved. THE SOFTWARE IN THIS PRODUCT WAS IN PART PROVIDED BY GENIVIA INC AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANYWAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE." This product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit (http://www.openssl.org/). This product includes cryptographic software written by Eric Young ([email protected]). This product includes software written by Tim Hudson ([email protected]). This product complies with the requirements concerning medical devices from the following regulatory bodies. For more information about compliance, refer to the Regulatory and Safety Guide for this product.

The document part number and revision are on each page of the document. The revision identifies the document’s update level. The revision history of this document is summarized in the following table. Revision

Date

Comments

A

17 October 2012

Internal Release

B

24 April 2013

Customer Release

C

15 July 2013

Revisions per SPR HCSDM00204349 relating to IEC 3rd Edition labeling, and SPR HCSDM00222909.

D

27 May 2015

Updated for MAC 2000 V1.1 SP3.

E

26 July 2016

Updated for maintenance projects. UDI symbol added to the Symbol table, and the FCC statement

F

25 November 2016

Updated for MAC 2000 Silex WW projects.

G

14 April 2017

Added the new accessories and supplies manual. Remove the supplies and accessories cleaning information.

H

8 June 2017

Update the following:

• Added Full Disclosure instruction • Added Auto Query instruction • Updated some product specification J

31 August 2017

Update the new capability battery related information.

K

30 September 2017

Update the embedded wireless module related information.

L

1 December 2017

Update the FCC, IC and RED information for the embedded wireless module.

To access other GE Healthcare Diagnostic Cardiology documents, go to the Common Documentation Library (CDL), located at www.gehealthcare.com/documents, and click Cardiology. To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website.

2

MAC™ 2000

2053535-002L 1 December 2017

Contents

1

Introduction Intended User of this Product ... 9 Indications for Use ... 9 Contraindications ... 10 Prescription Device Statement ... 10 Regulatory and Safety Information... 10 Safety Conventions... 10 Safety Hazards... 11 Classification of Medical Device... 13 Certification Information... 13 Recording ECGs During Defibrillation... 14 Accuracy of Input Signal Reproduction... 14 Modulating Effects in Digital Systems... 14 EMI/EMC/RF Safety Information... 14 Biocompatibility... 15 Legal Notice... 15 Supplies and Accessories... 16 Responsibility of the Manufacturer... 16 Responsibility of the Purchaser/Customer... 16 Product and Packaging Information... 16

Equipment Identification... 25 Product Label... 26 Serial Number Format... 26 Device Address Label and Rating Plate... 27 Product Codes... 27

Service Information... 28 Service Requirements... 28 Warranty Information... 28 Additional Assistance... 28

Manual Information ... 28 Manual Purpose... 28 Document Conventions... 28

Related Documents... 29

2

Product Overview Product Description ... 31 Product Specifications ... 31 Hardware Descriptions... 31 Optional Software Features... 37

2053535-002L

MAC™ 2000

3

Using the System... 37

Navigating the User Interface... 40 Resting ECG Power Up Mode... 41 Arrhythmia Power Up Mode... 41 Main Screen Power Up Mode... 42 Stress ECG Power Up Mode... 42 Order Manager Power Up Mode... 43

3

Setting Up the Equipment Inserting the Battery... 45 Connecting the AC Power... 45 Connecting the Patient Cable ... 46 Connecting the Barcode Reader ... 48 Connecting the LAN Option... 48 Connecting to LAN... 48 Connecting to WLAN... 49

Connecting the USB Wireless Option ... 49 Connecting External Devices (Stress Option) ... 49 Connecting an Internal Modem ... 49 Inserting the Paper ... 50 Turning on the System ... 50 Configuring the Device... 50 Testing the Device... 50

4

Preparing the Patient Preparing the Patient’s Skin ... 51 Electrode Placement ... 52 Resting ECG Placement... 52 Stress 12–Lead Placement... 55

5

Entering Patient Information Entering Patient Information With an Internal Keypad or External Keyboard ... 57 Entering Patient Information with a Barcode Reader ... 58 Scanning the Barcode... 58

Automatic Query... 59 4

MAC™ 2000

2053535-002L

6

Order Manager Communication Media ... 63 Simple Orders... 63 Advanced Order Manager ... 64 Downloading Orders... 64 Selecting and Completing Orders... 65

Using the Order Manager Interface ... 66 Deleting Orders... 66

7

Recording a Resting ECG Hookup Advisor ... 70 Resting ECGs ... 72 Recording a Resting ECG... 72 ECG Options... 73 Post-Acquisition Options... 75

Full Disclosure... 77 Generating a Full Disclosure ECG Report... 77 Full Disclosure Report Setup... 79

Special Considerations... 80 Recording ECGs of Pacemaker Patients... 80 Recording ECGs During Defibrillation... 81

Generating a Rhythm Report (Manual Recording) ... 81

8

Arrhythmia Mode Recording Recording in Arrhythmia Mode ... 83 Recording Arrhythmia ECGs... 83 Arrhythmia Recording Options... 84

Printing ... 85 Printing an Arrhythmia Report... 85 Arrhythmia Printing Options... 86

Arrhythmia Codes ... 86

9

RR Analysis RR Analysis Mode ... 89 RR Analysis Setup... 89 Acquiring a Recording for an RR Analysis Report... 93 Output Options... 93

10

Stress Testing Stress Mode Interface ... 96 Stress Test Information Bar... 96 Stress Test Keys... 98

2053535-002L

MAC™ 2000

5

Stress Options... 98

Conducting Stress Tests... 100 Conducting a Stress Test with a Treadmill or Ergometer... 100 Conducting a Stress Test with a Master’s Step Device... 102

11

Managing Internal Storage Importing Records ... 105 Printing the File Manager Directory... 106 Finding Records... 107 Editing Patient Data ... 107 Previewing Records... 108 Deleting Records ... 109 Printing Records... 109 Transmitting Records... 109 Exporting Records ... 111 Setting Up Export Options... 111 Exporting Records... 111

12

System Configuration Basic Setup... 113 Resting ECG Setup... 118 Arrhythmia Setup ... 130 Stress ECG Setup ... 133 Stress ECG Settings... 133 Editing Stress Protocols... 137

Communication Setup... 140 Country Setup ... 153 Print Setup Report... 154 Patient Setup... 155 User Setup... 161 Select Setup... 163 Import Setup ... 164

6

MAC™ 2000

2053535-002L

Export Setup... 165 Options Setup... 165 Service Setup... 167 Date/Time Setup ... 168 Order Manager Setup... 168 RR Analysis Setup... 169 PDF File Naming Convention... 169 Default Naming Convention... 169 Customizing the Naming Convention... 170

Retrieving Your Password ... 171 Exporting the Audit Trail ... 171

13

Maintenance Equipment Cleaning and Storage ... 173 Inspecting the Equipment... 173 Cleaning the Device... 174

Cleaning, Disinfecting and Storing Leadwires and Reusable Electrodes ... 175 Replacing Leadwire Adapters ... 175 Paper Maintenance ... 175 Replacing Paper... 176 Adjusting the Tray for Paper Size... 177 Removing the Paper Pack... 178 Storing Thermal Paper... 179

Battery Maintenance ... 179 Replacing the Battery... 179 Conditioning the Battery Pack... 180 Battery Status Indicator... 181

Supplies and Accessories ... 181

14

Troubleshooting General Troubleshooting Tips ... 183 Frequently Asked Questions (FAQ) ... 184 Equipment Problems ... 184 System Does Not Power Up... 184 ECG Data Contains Noise... 185 External Stress Equipment does not Move... 185 Paper Jams... 186

2053535-002L

MAC™ 2000

7

Import/Export/Save Errors... 186 SD Card Not Present... 186 Cannot Import or Transmit Records via Modem... 186 Cannot Transmit Records via LAN... 187 Cannot Transmit Records Via WLAN (Silex Wireless Bridge)... 187 Cannot Transmit Records via USB Wireless... 188 Cannot Transmit Records via Embedded Wireless Module... 188 Cannot Export to Shared Directories... 189

Acquisition/Printer Error Messages ... 189 Report Errors... 190 ACI-TIPI Statement is not Included on Report... 190

System Errors... 190

A

Creating Barcodes Setting Up the Patient Data Scheme... 195 Configuring the Barcode Reader... 196 Configuring the Barcode Reader Manually... 196 Configuring the Barcode Reader Automatically... 197

B

Master’s Step Data Master's Step Table ... 199 ST-T Changes ... 202

C

Technical Specifications System Specifications ... 203 Silex Wireless Bridge ... 210

D

Statement for MAC 2000 Silex Wireless Bridge FCC Statement ... 213 IC Statement ... 214 Complies with IMDA Standards ... 214

E

Statement for MAC 2000 Embedded Wireless Module FCC Statement ... 215 IC Statement ... 216 CE RED Information... 216

8

MAC™ 2000

2053535-002L

1

Introduction

This document describes the MAC™ 2000 ECG Analysis System, also referred to as the “product”, “system”, or “device”. The document is intended to be used by clinical professionals who use, maintain, and/or troubleshoot the system. Clinical professionals are expected to have a working knowledge of appropriate medical procedures, practices, and terminology used in the treatment of patients. This chapter provides general information required for the proper use of the system and this manual. Familiarize yourself with this information before using the system.

Intended User of this Product The MAC™ 2000 ECG Analysis System is a portable ECG acquisition, analysis, and recording system that is intended for use by trained operators in a hospital or medical professional’s facility environment, as well as used in clinics, physician offices, outreach centers, or wherever ECG testing is performed.

Indications for Use The MAC™2000 ECG Analysis System is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire, analyze, display, and record information for adult and pediatric populations in a hospital, medical professional’s facility, clinics, physician’s office or outreach centers. NOTE: Pediatric populations are defined as patients between the ages of 0 and 15 years. The MAC™2000 ECG Analysis System provides the following modes of operation: • Resting ECG mode • Arrhythmia mode • Exercise mode for exercise stress testing (optional) • RR analysis mode for RR interval analysis (optional) The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.

2053535-002L

MAC™ 2000

9

Introduction

Arrhythmia detection is provided for the convenience of automatic documentation. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

Contraindications This system is not intended for use in the following manner: • During patient transport • With high-frequency surgical units • As an intra-cardiac application • As a vital signs physiological monitor

Prescription Device Statement CAUTION: United States federal law restricts this device to sale by or on the order of a physician.

Regulatory and Safety Information This section provides information about the safe use and regulatory compliance of this system. Familiarize yourself with this information, and read and understand all instructions before attempting to use this system. The system software is considered medical software. As such, it was designed and manufactured to the appropriate medical regulations and controls. NOTE: Disregarding the safety information provided in this manual is considered abnormal use of this system and could result in injury, data loss, or a voided warranty.

Safety Conventions A Hazard is a source of potential injury to a person, property, or the system. This manual uses the terms DANGER, WARNING, CAUTION, and NOTICE to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with the following definitions and their significance. Definitions of Safety Conventions

10

Safety Convention

Definition

DANGER

Indicates an imminent hazard, which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in death or serious injury.

MAC™ 2000

2053535-002L

Introduction

Definitions of Safety Conventions (cont'd.) Safety Convention

Definition

CAUTION

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in moderate or minor injury.

NOTICE

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in the loss or destruction of property or data.

Safety Hazards The following messages apply to the system as a whole. Specific messages may also be provided elsewhere in the manual. WARNING: EQUIPMENT MALFUNCTION - Any attempt by unauthorized personnel to service the device could result in equipment malfunction and void the warranty. This equipment contains no user-serviceable parts. Refer servicing to authorized service personnel. WARNING: PATIENT INJURY–STRANGULATION - Cables present a possible strangulation hazard. To avoid possible strangulation, route all cables away from the patient’s throat. Use a short version of cable for pediatric patients. WARNING: PERSONAL INJURY–STUMBLING HAZARD- Patients can become entangled in the cables and leadwires connected to the device, which could cause the patient to stumble or trip. Route cables and leadwires in a way to avoid creating a stumbling hazard: keep them off the floor, and route leadwires away from the patient’s legs and the healthcare provider’s work area. WARNING: MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electric fields can interfere with the acquisition of ECG readings. Make sure that all peripheral components operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems (cellular phones) and so forth, are possible sources of interference because they may emit higher levels of electromagnetic radiation. Verify the performance of the system before use. WARNING: EXPLOSION HAZARD - Using this device in the presence of anesthetic vapors or liquids can cause explosions. Do not use this device in the presence of anesthetic vapors or liquids. Only persons with adequate training in the correct use of this device may use this device.

2053535-002L

MAC™ 2000

11

Introduction

WARNING: EQUIPMENT FAILURE - Polarizing electrodes (stainless steel or silver constructed) may cause the electrodes to retain a residual charge after defibrillation. A residual charge blocks acquisition of the ECG signal. Whenever patient defibrillation is a possibility, use non-polarizing electrodes (silver-silver chloride construction) for ECG monitoring. WARNING: PERSONAL INJURY - Contact with patients during defibrillation can cause serious injury or death. Do not contact patients during defibrillation. Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only GE Healthcare recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation. WARNING: INTERPRETATION HAZARD - Results of the automated QT analysis are not considered a diagnosis. A qualified physician or cardiologist must review and confirm the measurements and waveforms recorded by the system. It should be used only as an adjunct to the clinical history, symptoms, and results of other tests. WARNING: INTERPRETATION HAZARD - Computerized interpretation is only significant when used in conjunction with clinical findings. A qualified physician must overread all computer-generated tracings. WARNING: POOR SIGNAL QUALITY - Improper skin preparation can cause poor signal quality during the ECG recording. Careful skin preparation is the key to an interference-free ECG. WARNING: IMPROPER USE - This is a prescriptive device. This equipment is intended for use by or under the direct supervision of a licensed healthcare practitioner. WARNING: EXPLOSION HAZARD - Batteries may explode in fires Do not dispose of the battery by fire. Follow local environmental guidelines concerning disposal and recycling. WARNING: ELECTRIC SHOCK HAZARD/SYSTEM MALFUNCTION Liquids inside a device can cause electric shock or system malfunction. Do not allow liquids to enter the device. If liquids enter the device, turn it off and inform your service technician. Do not use the device until it is checked by a service technician.

12

MAC™ 2000

2053535-002L

Introduction

WARNING: ELECTRIC SHOCK - Improper connection of this equipment may cause electric shock. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. NOTE: Follow the instructions provided. Do not position equipment in a way that makes it difficult to disconnect the device when using an appliance coupler, mains plug, or other separable plug as a means of isolation.

Classification of Medical Device The device is classified as follows, according to IEC 60601-1: Medical Device Classifications Category

Classification

Type of protection against electrical shock

Class I internally powered equipment

Degree of protection against electrical shock

Type CF defibrillation-proof applied part

Degree of protection against solids

The IP code for this device is IP20. Protected against solid foreign objects with a diameter of 12.5 mm and greater The object probe, a sphere 12.5 mm diameter, shall not fully penetrate. The jointed test finger 12 mm diameter, 80 mm length, shall have adequate clearance from hazardous parts.

Degree of protection against harmful ingress of liquids (IP20)

The IP code for this device is IP20. Non-protected This device is ordinary equipment (enclosed equipment without protection against ingress of liquids)

Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or with nitrous oxide

Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide

Method(s) of sterilization or disinfection recommended by the manufacturer

Not applicable

Mode of operation

Continuous operation

Certification Information Medical Equipment With respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601–1, and CAN/CSA C22.2 NO. 601.1.

2053535-002L

MAC™ 2000

13

Introduction

Recording ECGs During Defibrillation This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery, as required by test standards. The patient signal input of the acquisition module is defibrillation-proof. Therefore, it is not necessary to remove the ECG electrodes prior to defibrillation. When using stainless steel or silver electrodes, a defibrillator discharge current may cause the electrodes to retain a residual charge causing a polarization or DC offset voltage. This electrode polarization blocks acquisition of the ECG signal. To avoid this condition, if there is a situation where a defibrillation procedure might be necessary, use non-polarizing electrodes (which do not form a DC offset voltage when subjected to a DC current) such as silver/silver-chloride types. If you use polarizing electrodes, GE Healthcare recommends disconnecting the leadwires from the patient before delivering the shock. Electrode defibrillation recovery is the ability of the electrode to allow the ECG trace to return after defibrillation. GE Healthcare recommends using non-polarizing disposable electrodes with defibrillation recovery ratings as specified in AAMI EC12 5.2.2.4. AAMI EC12 requires that the polarization potential of an electrode pair does not exceed 100 mV 5 seconds after a defibrillation discharge. Refer to the supplies and accessories reference guide for this system for a list of approved electrodes.

Accuracy of Input Signal Reproduction • Overall System Error meets AAMI EC11 3.2.7.1 requirements. Overall System Error is between or within ±5% or ±40 µV, whichever is greater. • Frequency Response meets AAMI EC11 3.2.7.2 requirements, using testing methods A and D. Frequency response is between or within ±10% between 0.67 and 40 Hz and between +0 and -10% for 20 ms, 1.5 mV triangular input.

Modulating Effects in Digital Systems This device uses digital sampling techniques that may produce some variation in amplitudes of Q, R, and/or S waves from one heart beat to the next, which may be particularly noticeable in pediatric recordings. If you observe this phenomenon, be aware that the origin of amplitude variations is not entirely physiological. For measuring voltages of Q, R, and S waves, GE Healthcare advises using the QRS complexes with the largest deflection of the particular waves.

EMI/EMC/RF Safety Information This system is designed and tested to comply with applicable regulations regarding EMC and must be installed and put into service according to the EMC information stated in the Electromagnetic Compatibility appendix of the Service and/or Operator’s manual. Changes or modifications to this system not expressly approved by GE Healthcare could cause EMC issues with this or other equipment. Mains power should be a standard commercial or hospital environment.

14

MAC™ 2000

2053535-002L

Introduction

Before installing or using the device or system, be aware of the proximity of known RF sources, such as the following: • Radio and TV stations • Portable and mobile RF communication devices (cell phones, two-way radios) • X-ray, CT, or MRI devices These devices are also possible sources of interference as they may emit higher levels of electromagnetic radiation. WARNING: EQUIPMENT MALFUNCTION/INTERFERENCE - Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. Do not use portable phones or other electronic equipment that may emit radio frequency (RF) near this system. WARNING: EQUIPMENT MALFUNCTION/INTERFERENCE - Do not use the equipment or system adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, test the equipment or system to verify normal operation in the configuration in which you are using it. WARNING: ACCESSORIES/COMPONENTS - Adding accessories or components, or modifying the medical device or system, may result in increased EMISSIONS or decreased IMMUNITY of the device or system. Use the following resources for more information on EMI/EMC and RF concerns: • The Supplies and Accessories Reference Guide for your system • Qualified GE Healthcare or approved third-party personnel • The Electromagnetic Compatibility appendix in your system service or operator’s manual NOTE: Compliance provides reasonable protection against radio-frequency interference. However, there is no guarantee that interference will not occur in a particular installation. You can tell whether this device or system is causing interference by turning it off. If the interference stops, it was most likely caused by the device or system.

Biocompatibility The parts of the system described in this manual that come into contact with the patient during the intended use, including all accessories, fulfill the biocompatibility requirements of the applicable standards. If you have questions in this matter, contact your GE Healthcare representative.

Legal Notice GE Healthcare software contains several fields that can be filled in before performing an ECG. Some of these fields are required, while others are optional and left to the user to assess whether they are needed to perform the exam. The field Race is one 2053535-002L

MAC™ 2000

15

Introduction

of these optional fields. Race has been acknowledged by the medical profession as useful to analyze some pathologies. You should be aware that, in some jurisdictions, the processing of data revealing an individual's racial origin is subject to legal requirements, such as obtaining the patient's prior consent. If you elect to collect this type of data, it is your responsibility to ensure that you comply with all applicable legal requirements.

Supplies and Accessories You should use only supplies and accessories that GE Healthcare recommends. For a list of recommendations, refer to the supplies and accessories reference guide for this system Contact GE Healthcare before using anything that is not recommended for this system.

Responsibility of the Manufacturer GE Healthcare is responsible for the safety, reliability, and performance of hardware supplied by GE Healthcare only if the following conditions are met: • Assembly operations, extensions, readjustments, modifications, or repairs are performed by persons authorized by GE Healthcare. • The electrical installation of the room where the device is used complies with the requirements of the appropriate local, state, and other government regulations. • The equipment is used in accordance with the instructions for use.

Responsibility of the Purchaser/Customer The customer is responsible for providing appropriate desks, chairs, electrical wall outlets, network connections, and analog phone lines, and for locating any of the system components described in this manual in compliance with all local, state, and national codes.

Product and Packaging Information This section identifies the following: • Hardware labels and their locations on page 17 • Symbol Descriptions on page 18

16

MAC™ 2000

2053535-002L

Introduction

Hardware Label Locations

Label Descriptions on Hardware and Packaging Item Label

Location

Description

1

Back of the device

Product Label Identifies this device. See “Product Label” on page 26 for a description of the label contents.

2

Back of the device

Device Address Label and Rating Plate It provides regulatory and cautionary information. See “Device Address Label and Rating Plate” on page 27 for an explanation of the label.

3

Bottom cover of the device

The Option Code label. Use the option codes to setup the purchased options in your system. See “Options Setup” on page 165 for an explanation of the Option Codes.

4

2053535-002L

On the shipping package

MAC™ 2000

Environmental symbols required for shipping.

17

Introduction

Label Descriptions on Hardware and Packaging (cont'd.) Item Label

Location

Description

5

On the shipping package

Battery Shipping Label. FRAGILE-Lithium Ion batteries can cause fire if damaged.

6

On the shipping package

The shipping label.

Symbol Descriptions The following table describes symbols or icons that may be on the device or its packaging. Not all of the symbols defined in the table apply to your device or its packaging. Symbols are used to convey warnings, cautions, prohibitions, mandatory actions, or information. Any symbol on your device or packaging with markings in color indicates there may be a danger, warning, or mandatory action. Any symbol on your device or packaging that is in black and white provides additional information or may indicate a caution. Familiarity with these symbols assists in the use and disposal of the equipment. For equipment symbols not shown, refer to the original equipment manufacturer (OEM) manuals. Symbol Descriptions Symbol

Description Catalog or Orderable Part Number Indicates the manufacturer's catalog or part number. Serial Number Indicates the manufacturer's serial number. Batch Code or Lot Number Indicates the manufacturer's batch code or lot number. Date of Manufacture (Year-Month) Indicates the original manufacture date for this device.

18

MAC™ 2000

2053535-002L

Introduction

Symbol Descriptions (cont'd.) Symbol

Description Manufacturer Indicates the name and address for the manufacturer of this device. It may also include the date it was manufactured. Authorized Representative in the European Community Indicates the name and address of the authorized representative in the European Community for this device. Unique Device Identification is a unique marking for identification of the medical device. Rx Only US Federal law restricts this device to sale by or on the order of a physician. 12SL Indicates the device uses the Marquette™ 12SL ECG Analysis Program to analyze and interpret ECG readings.

IPxy

IP Code (Ingress Protection Rating) Classifies and rates the degree of protection provided against the intrusion of solid objects (such as body parts like hands and fingers, dust, accidental contact), and liquids. The first numeral (x) represents the degree of protection against the ingress of solid objects. The second numeral (y) represents the degree of protection against the ingress of liquids. For products with an IPxy rating, see the Classification of Medical Device in this chapter for a description of that rating. Not all products have an IPxy rating. Class II Equipment Identifies equipment that meets the safety requirements specified for class II equipment by IEC 60601–1. This device was designed so that it does not require a safety connection to electrical earth (US ground). No single failure results in dangerous voltage becoming exposed and causing an electric shock. This is achieved without relying on an earthed metal casing. Consult Instructions for Use Consult the operating instructions. Defibrillation-proof Type BF Applied Part Identifies a defibrillation-proof type BF applied part on medical equipment that complies with IEC 60601–1. This device meets the requirements for protection against electric shock for an earth-free (floating) applied part (one intended for contact with patients). Defibrillation-proof Type CF Applied Part Identifies a defibrillation-proof type CF applied part on medical equipment that complies with IEC 60601–1. This device meets the requirements for protection against electric shock for an earth-free (floating) applied part (one intended for contact with patients) for cardiac application.

2053535-002L

MAC™ 2000

19

Introduction

Symbol Descriptions (cont'd.) Symbol

Description No User– or Field-serviceable Parts Do not open or disassemble the device for any reason.

Protective Earth (ground) Identifies the terminal of a protective earth (ground) electrode or any terminal that is intended for connection to an external conductor for protection against electric shock in case of a fault. Non-ionizing Electromagnetic Radiation Indicates that the equipment emits elevated, potentially hazardous, levels of non-ionizing radiation (electromagnetic energy) for diagnosis or treatment. Follow Instructions For Use Read and understand the operator's manual before using the device or product. As a mandatory action sign, this symbol is identified by a blue background and white symbol.

CAUTION: SAFETY GROUND PRECAUTION Pulling on the cable can cause the cord to deteriorate resulting in electrical problems. Remove the power cord from the mains source by grasping the plug. DO NOT pull on the cable.

CAUTION: CONSULT ACCOMPANYING DOCUMENTS There may be specific warnings or precautions associated with the device that are not otherwise found on the label. Consult the accompanying documentation for more information about safely using this device.

CAUTION: ELECTRIC SHOCK Indicates the presence of hazardous energy circuits or electric shock hazards. To reduce the risk of electric shock hazards, do not open this enclosure. Refer servicing to qualified personnel.

CAUTION: HOT SURFACE Indicates that the marked item may be hot. Take appropriate precautions before touching the item.

20

MAC™ 2000

2053535-002L