MAC 7 Regulatory and Safety Manual Rev F Sept 2021

Publication Information This document describes version 1.00 of the MAC™ 7 Resting ECG Analysis System, also referred to as the “product” or "system" or "device". It does not apply to earlier product versions. Due to continuing product innovation, specifications in this document are subject to change without notice. 12SL, CASE, CardioSoft, InSite ExC, MAC, MACCRA, MARS, MUSE, Marquette, MobileLink, and MULTI-LINK 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.

Date of first CE mark - 2020. 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

Comment

A

10 April 2020

Customer Release

B

3 July 2020

Update legal manufacturer and registration information

C

10 September 2020

Add symbol: General Warning Sign

D

1 December 2020

Add Declaration of Conformity

E

27 April 2021

Add Essential Performace section

F

24 September 2021

Update Product and Packaging Information chapter

Access other GE Healthcare Diagnostic Cardiology documents at the Customer Documentation Portal. Go to https:// www.gehealthcare.com/en/support/support-documentation-library and scroll to the bottom of the page. To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website. This document describes the MAC™ 7 Resting ECG Analysis System, also referred to as the” product”, “system”, or “device”. This document is intended to be used by an operator of the MAC™ 7 Resting ECG Analysis system. The MAC™ 7 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. This document provides information required for the proper use of the system. Familiarize yourself with this information and read and understand all instructions before attempting to use this system. Illustrations in this document are provided as examples only. Depending on system configuration, screens in the document may differ from the screens on your system. Patient names and data are fictitious. Any similarity to actual persons is coincidental. Support GE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problems that may arise during the installation, maintenance, and use of this product. If you require additional assistance, contact your GE Healthcare representative or GE Healthcare support at one of the following numbers: •

North America: 1-800-558-7044

•

Europe: +49 761 45 43 -0

•

Asia: +86 21 3877 7888

Training This document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use of the product, you should request training assistance from GE Healthcare. To see available training, go to the GE Healthcare training website www.gehealthcare.com/training.

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For more self-paced course offerings, tools, and reference guides you may find useful, please visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.

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Table of Contents Publication Information... 2 1: Regulatory Information... 6

Intended Use... 6 Indications for Use... 6 Contraindications... 7 Clinical Benefits...7 Prescription Device Statement... 7 Classification of Medical Device... 7 Certification Information... 8 Recording ECGs during Defibrillation... 8 Modulating Effects in Digital Systems... 9 Biocompatibility...9 Legal Notice...9 Responsibility of the Manufacturer... 9 Responsibility of the Purchaser/Customer...10 Notification to Member States...10 Warranty Information... 10

2: Safety Information... 11

Safety Conventions...11 Safety Hazards... 11 Supplies and Accessories...15

3: Product and Packaging Information...16

Hardware Label Locations...16

4: Equipment Identification...20 Serial Number Label... 20 Device Address Label and Rating Plate... 20 Symbol Descriptions... 21 Serial Number Format... 25 Unique Device Identifier...26

5: Electromagnetic Compatibility (EMC)... 27

Guidance and Manufacturer’s Declaration-Electromagnetic Emissions...27 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity...28 Essential Performance... 29

6: Wireless Regulations... 31 FCC Compliance...31 IC Compliance...32 RED Information...32

A: Declaration of Conformity... 34

Regulatory Information

1 Regulatory Information Familiarize yourself with this information before attempting to use this system. Keep this manual with your Operator Manual and equipment at all times, and periodically review it. This section provides information about the regulatory compliance of this system. The system software is considered medical software. As such, it was designed and manufactured to the appropriate medical regulations and controls.

Intended Use The MAC 7 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system delivers 3, 6, or 12 lead ECG’s and interpretive analysis. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional. The MAC 7 ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional’s facility or wherever ECG testing is performed.

Indications for Use The MAC 7 Resting ECG Analysis System is a non-invasive prescription device. • The device is indicated for use to acquire, analyze, display 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. 6

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Regulatory Information

• The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Contraindications This MAC 7 Resting ECG Analysis System is not intended in the manners below: • During patient transport • With high-frequency surgical units • As an intra-cardiac application • As a sole means of diagnosis • As a vital signs physiological monitor

Clinical Benefits The clinical benefits of the MAC 7 Resting ECG Analysis System include: analysis of ECG data (QRS Complex) for diagnostic interpretation by the clinician/physician to assist with clinical decision making in the care of patients with heart disease. These clinical benefits follow the devices' intended uses and indications for use.

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

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

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Category

Classification

Type of protection against electrical shock

Class I, internally powered

Degree of protection against electrical shock

Type CF defibrillation-proof applied part

Degree of protection against harmful ingress of solids and liquids

The Ingress Protection (IP) code for this device is IP 20.

Degree of safety of application in the presence of a 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

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Regulatory Information

Category

Classification

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

Not applicable

Mode of operation

Continuous operation

Certification Information Table 2: Certification Information This system bears CE mark 0197 indicating it conforms with the provisions of Council Regulation EU 2017/745 concerning medical devices, and it fulfills the requirements of Annex I of this regulation. The system is in radio-interference protection class B in accordance with EN 55011. The country of manufacture is indicated on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”. The medical device has a lifetime of 7 years with respect to the Council Regulation EU 2017/745 Annex I, Requirement 6. Medical Equipment With respect to electric shock, fire, and mechanical hazards only in accordance with IEC 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. 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 is necessary, use non-polarizing electrodes such as silver/silver-chloride types, which do not form a DC offset voltage when subjected to a DC current. 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 rating as specified in AAMI

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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 guide for this system for a list of approved electrodes.

Modulating Effects in Digital Systems This section describes the modulating effects that may occur in digital systems of the product. 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.

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 populated before performing an ECG. Some of these fields are required, 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 make sure that you comply with all applicable legal requirements.

Responsibility of the Manufacturer This section describes the responsibility of GE Healthcare as the manufacturer of your product. GE Healthcare is responsible for the safety, reliability, and performance of hardware supplied by GE Healthcare only if the conditions below are met: • Assembly operations, extensions, readjustments, modifications, or repairs are performed by persons authorized by GE Healthcare. 2109599-003F

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Regulatory Information

• 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 the manuals in compliance with all local, state, and national codes. Lack of data security may compromise patient privacy. GE Healthcare recommends that you take appropriate steps to secure the privacy of communication on your network when using this product.

Notification to Member States The user and/or patient should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Warranty Information This device is considered GE Healthcare-supplied hardware. Only authorized GE Healthcare service personnel should service the device. Any unauthorized attempt to repair equipment under warranty voids that warranty. It is the user’s responsibility to report the need for service to GE Healthcare or to one of their authorized agents.

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Safety Information

2 Safety Information Safety Conventions This section describes the safety conventions used in the documentation for the product. A Hazard is a source of potential injury to a person, property, or the system. The manuals for this system use the terms DANGER, WARNING, CAUTION, and NOTICE to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with the definitions below and their significance. Table 3: Definitions of Safety Conventions Safety Convention

Description

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.

Safety Hazards The safety messages below alert you to potentially hazardous conditions that could arise during the normal use of this product and recommend steps that can be taken to avoid those conditions. Safety messages pertaining to hazardous conditions that may arise during specific actions may also be provided during the discussion of those actions in this or other manuals for this product.

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Safety Information

CAUTION: 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. Please contact the authorized service personnel to service the device. NOTICE: EQUIPMENT COMPATIBILITY - Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility. 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. CAUTION: 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 symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only GE 12

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Healthcare recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation. CAUTION: EXPLOSION HAZARD - Do NOT use in the presence of flammable anesthetics vapors or liquids. 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: IMPROPER USE - This is a prescriptive device. This equipment is intended for use by or under the direct supervision of a licensed healthcare practitioner. NOTICE: BATTERY EXPLOSION HAZARD - Batteries may explode in fires. Do not dispose of the battery by fire or burning. 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 main with protective earth.

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Safety Information

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. CAUTION: ACCESSORIES (SUPPLIES) - To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies, Inc. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. CAUTION: ACCESSORIES (EQUIPMENT) - The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: Use of the accessory in the PATIENT VICINITY; and Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. NOTICE: DATA LOSS - Formatting the device’s internal flash drive erases all the data in memory and returns the device to its factory settings. If possible, back up or record any data that you do not want to lose before formatting the device's internal flash drive. WARNING: ELECTRIC SHOCK HAZARD - The conductive parts of electrodes and associated connectors for leadwire, including the neutral electrode, should not contact any other conductive parts including earth. WARNING: ELECTRIC SHOCK HAZARD - Devices which connected to the same Ethernet/LAN with MAC 7 should comply with IEC 60950/IEC60601 or equivalent safety standard. 14

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CAUTION: DISPOSAL HAZARD - At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products. If you have questions concerning disposal of the product, please contact GE or its representatives. CAUTION: INTERCONNECTED DEVICES - When several items of medical equipment are interconnected, summation of leakage current must meet the leakage current as per IEC 60601-1. Connect the device only to the GE approved supplies and accessories. CAUTION: ISOLATION FROM SUPPLY MAINS - Do not position the device so that it is difficult to operate the disconnection of the AC power supply of the device.

Supplies and Accessories This section is in regard to the supplies and accessories you may purchase for your product. You should use only supplies and accessories recommended by GE Healthcare. For a list of recommendations, refer to the supplies and accessories guide for this system. Contact GE Healthcare before using anything that is not recommended for this system.

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Product and Packaging Information

3 Product and Packaging Information The illustrations and tables in this section describe the labels and their location on your device and its packaging. Contact your local GE Healthcare service representative, if the device packaging is: • Damaged. • Accidentally opened. • Exposed to an environment that does not meet the prescribed conditions.

Hardware Label Locations The illustrations and tables in this section describe the labels and their location on your device and its packaging.

Table 4: Label Descriptions on the Device and Packaging

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Item

Label

Location

Description

1

Product and Rating Label

Back of the device

Regulatory and cautionary information. See Device Address Label and Rating Plate on page 20 for an explanation of the label.

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Product and Packaging Information

Table 5: Label Descriptions on the Device and Packaging

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Item

Label

Location

Description

2

Country-specific Label

Right side of the Country registration information. device

3

Serial Number Label

Right side of the Device identification. See Serial Number Label on page device 20 for a description of the label contents.

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Product and Packaging Information

Table 6: Label Descriptions on the Device and Packaging Item

Label

Location

Description

4

Option Code Label

Bottom of the device

Use the option codes to set up the purchased options in your system.

5

Wireless Label

Bottom of the device

The wireless registration information.

Table 7: Label Descriptions on the Device and Packaging

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Item

Label

Location

Description

6

Environmental Symbols

On the shipping package

Safety indicators required for shipping. For a full description of symbols, see Symbol Descriptions on page 21.

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Product and Packaging Information

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Item

Label

Location

Description

7

Battery Shipping On the shipping Label package

FRAGILE-Lithium Ion batteries can cause fire if damaged.

8

Shipping Label

On the shipping package

Regulatory and safety shipping information.

9

Radio Equipment Directive (RED) Label

On the shipping package

The Radio Equipment Directive registration information.

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Equipment Identification

4 Equipment Identification Serial Number Label The serial number label is in the format as follows:

Table 8: Serial Number Label Format Item

Description

1

Product Part Number

2

Product Model

3

Date of Manufacture in YYYY-MM-DD Format

4

Country of Origin

5

Device Serial Number

6

UDI Barcode

Device Address Label and Rating Plate The device address label and rating plate is in the format as follows:

20

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