MAC 2000 Service Manual sw ver 1.1 Rev M Dec 2017

Publication Information The information in this manual applies only to the MAC™ 2000 ECG Analysis System, Version 1.1. It does not apply to earlier product versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. MUSE, MAC, CASE/CardioSoft, and 12SL 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 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

15 July 2013

Customer Release

C

13 August 2013

Updated for SPR 229270.

D

8 September 2014

Updated with information for new display replacing obsolete display.

F

12 July 2016

Update for maintenance projects.

G

25 October 2016

Update the Silex FRU parts for Silex WW project.

H

26 April 2017

Added the new supplies and accessories manual. Updates made for the simplification and clarity through the Keep it Simple Service Initiative.

J

8 June 2017

Update according to MAC2000 SP5 project. Update according to add the new print cable related information. Updated some product speechification

K

5 September 2017

Update the information about the new capability battery.

L

30 September 2017

Update the information about embedded wireless module.

M

11 December 2017

Update to add the detail information about inset the antenna of 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

2053535-003M 11 December 2017

10

MAC™ 2000

2053535-003M 11 December 2017

Contents

1

Introduction Intended User of this Product ... 17 Indications for Use ... 17 Contraindications ... 18 Prescription Device Statement ... 18 Regulatory and Safety Information... 18 Safety Conventions... 18 Safety Hazards... 19 Classification of Medical Device... 21 Certification Information... 21 Recording ECGs During Defibrillation... 21 Accuracy of Input Signal Reproduction... 22 Modulating Effects in Digital Systems... 22 EMI/EMC/RF Safety Information... 22 Biocompatibility... 23 Legal Notice... 23 Supplies and Accessories... 24 Responsibility of the Manufacturer... 24 Responsibility of the Purchaser/Customer... 24 Product and Packaging Information... 24 Training... 32

Equipment Identification... 32 Product Label... 33 Serial Number Format... 33 Device Address Label and Rating Plate... 34 Product Codes... 34

Service Information... 35 Service Requirements... 35 Warranty Information... 35 Additional Assistance... 35

Manual Information ... 35 Manual Purpose... 35 Document Conventions... 35

2

Product Overview Product Description ... 37 Hardware Overview ... 37 Front View... 38 Rear View... 38 Side View... 39 Internal View... 40

2053535-003M

MAC™ 2000

11

Keypads... 41

Architecture and Theory of Operation ... 44 Block Diagram... 44 Hardware/Firmware Architecture... 46 Product Interfaces... 46

3

Installing the USB Powered Silex Wireless Bridge Installing the Silex Wireless Bridge ... 50

4

Installing the Embedded Wireless Module Installing the Embedded Wireless Module ... 54 Preparing the System... 54 Removing the Battery... 55 Removing the Top Cover Assembly... 56 Removing the Display Bottom Cover... 58 Installing the Antenna... 60 Removing the Main Board... 63 Replacing the Main Board... 65 Reattaching the Top Cover Assembly... 66 Installing the Battery... 69

5

Service Setup Accessing Service Setup... 71 Accessing Device Settings... 72 Event Log ... 72 Setting Up Event Logging... 73 Exporting the Event Log... 74

Accessing System Diagnostics... 74 Testing the Display... 75 Testing the Speaker... 77 Testing the Keypad... 78 Testing the Acquisition Module... 79 Checking the Battery Status... 79 Testing the Writer... 80 Communications Tests... 83 Testing the Patient Leadwires... 89 Printing a Service Report... 90

Updating the Software ... 90 Formating the Flash Memory ... 98 Opening a Command Prompt... 100 Setting the WIFI Parameter... 101 Setting the WIFI Parameter for Dongle Wireless Module... 101 Setting the WIFI Parameter for Embedded Wireless Module... 103

Wireless Country of Operation... 105

12

MAC™ 2000

2053535-003M

6

Maintenance Recommended Maintenance ... 107 Required Tools and Supplies ... 107 FRU Replacement Procedures ... 108 High Level FRU Identification... 108 Preparing the System for FRU Replacement... 109 Battery... 109 Device Covers... 111 Power Supply... 134 Power Inlet Module... 136 Printer... 138 Display Assembly... 155 Keypad... 162 Internal Modem... 169 Antenna... 171 Embedded Wireless Module... 176 PWA... 177 KISS Pump Assembly (Option)... 183

Functional Checkout ... 188 Visual Inspections... 190 Functional Checkout Procedures... 190

7

Troubleshooting ECG Data Noise ... 193 General Fault Isolation... 194 Power Up Self Test... 194 Visual Inspection... 195 Event Logging... 196 Diagnostic Tests... 196

Error Codes ... 197

8

Parts List Part Identification ... 199 FRU Lists... 211 Cover Bottom (2066261-001)... 211 Printer (2066261-002/2066261-080)... 211 Printer Motor and Gears (2066261-003)... 211 Printer Door (2066261-004)... 211 Cover Top, Color Chassis, Hardware (2066261-005)... 212 Main PWA (2066261-077)... 212 Display Plastic Parts - AUO (2066261-007)... 212 Keypad (Stress or Non-Stress)... 213 Hardware - 1 (2066261-009)... 213 Harness/Cables (2066261-010/2066261-076)... 213 Printer Data Cables (2066261-066/2066261-076)... 214 Hardware 3 and Power-In Module (2066261-011)... 214 Power Supply (2066261-012)... 214 Battery (2066261-013)... 214 High Capacity Battery (2066261-085)... 214 Display and O-Rings (2066261-014)... 215 NLT Display, Display Holder, and O-Rings (2066261–061)... 215

2053535-003M

MAC™ 2000

13

Display Overlay and O-Rings - AUO (2066261-015)... 215 Display Overlay and O-Rings - NLT (2066261-063)... 215 Cover Top and Plastic Parts - 1 (2066261-016)... 215 Plastic Parts - Printer/Paper Tray (2066261-017)... 216 DOOR SENSOR PARTS (2066261-070)... 216 Paper Sensor (2066261-018)... 216 Print Head Assy (2066261-019)... 216 Static Brush (2066261-020)... 216 KISS Pump (2066261-021)... 217 KISS PUMP ASSEMBLY WITH BASE (2066261-069)... 217 Internal Modem (2066261-022)... 217 Display Assembly - NLT with Non-stress Keypad... 217 Display Assembly - NLT with Stress Keypad... 218 Keypads, Non-Stress... 219 Keypads, Stress... 220 Barcode Scanner Kits (USB Data Matrix)... 220 Power Supply Cords... 221 MAC 2000 Data SDHC Card (2066261-065)... 221 Software Update SD Card... 222 USB Wi-Fi Module... 222 Silex Wireless Bridge - US (2066261-071)... 222 Silex Wireless Bridge Kit - WW (2066261-075)... 222 Silex Wireless Bridge Cables (2066261-072)... 222 Silex Wireless Bridge - Dual Locks (2066261-073)... 222 Upgrade Embedded Wireless (2072532-116)... 222 FRU MAC 2000 Antenna (2066261-086)... 223 FRU MAC 2000 Wi-Fi Module (2066261-087)... 223 FRU MAC 2000 Main Board with Embedded Wireless Socket (2066261-088)... 223 FRU Supporting Foam and Clip (2066261-089)... 223

9

System Configuration Basic Setup... 225 Resting ECG Setup... 230 Arrhythmia Setup ... 242 Stress ECG Setup ... 245 Stress ECG Settings... 245 Editing Stress Protocols... 249

Communication Setup... 252 Country Setup ... 265 Print Setup Report... 266 Patient Setup... 267 User Setup... 273 Select Setup... 275 Import Setup ... 276 Export Setup... 277 Options Setup... 277 14

MAC™ 2000

2053535-003M

Service Setup... 279 Date/Time Setup ... 280 Order Manager Setup... 280 RR Analysis Setup... 281 PDF File Naming Convention... 281 Default Naming Convention... 281 Customizing the Naming Convention... 282

Retrieving Your Password ... 283 Exporting the Audit Trail ... 283

A

Related Documents Documents Related to MAC™ 2000 ECG Analysis System... 285 Documents Available in Other Languages... 285

B

Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration-Electromagnetic Emissions ... 289 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity... 290 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity... 291 Recommended Separation Distances ... 292

C

Technical Specifications System Specifications ... 295 Silex Wireless Bridge ... 302

D

Wireless Country List Allowable Channels... 305

E

Mainboard and Print Assembly Replacement Matrix ... 307

2053535-003M

MAC™ 2000

15

16

MAC™ 2000

2053535-003M

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 anyone who maintains or troubleshoots this equipment. 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. 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. 2053535-003M

MAC™ 2000

17

Introduction

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

18

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.

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.

MAC™ 2000

2053535-003M

Introduction

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. 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.

2053535-003M

MAC™ 2000

19

Introduction

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. 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.

20

MAC™ 2000

2053535-003M

Introduction

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.

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.

2053535-003M

MAC™ 2000

21

Introduction

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. 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

22

MAC™ 2000

2053535-003M

Introduction

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 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. 2053535-003M

MAC™ 2000

23

Introduction

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 24 • Symbol Descriptions on page 25

Hardware Label Locations

24

MAC™ 2000

2053535-003M

Introduction

Item Label

Location

Description

1

Back of the device

Product Label Identifies this device. See “Product Label” on page 33 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 34 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. Use the option codes to setup the purchased options in your system. Refer to “Options Setup” in the operator manual.

4

On the shipping package

Environmental symbols required for shipping.

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

2053535-003M

MAC™ 2000

25

Introduction

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. 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

26

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.

MAC™ 2000

2053535-003M

Introduction

Symbol Descriptions (cont'd.) Symbol

Description 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. 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.

2053535-003M

MAC™ 2000

27