GE Healthcare MAC™ 7 Resting ECG Analysis System Version 1.00 Regulatory and Safety Manual 2109599-003 A MAC™ 7 Resting ECG Analysis System Version 1.00 English © 2018 General Electric Company All Rights Reserved.
Publication Information This document describes version 1.00 of 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. MUSE, MAC, MARS, CASE, CardioSoft, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare.
Table of Contents Publication Information....................................................................... 2 1: Regulatory Information....................................................................................... 4 Intended Use............................................................................................................................................................ 4 Indications for Use...........................................................................................
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.
Regulatory Information 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 sole means of diagnosis • 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. Classification of Medical Device The device is classified as follows according to IEC 60601-1.
Regulatory Information 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.
Regulatory Information collect this type of data, it is your responsibility to ensure 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.
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 following definitions and their significance.
Safety Information equipment contains no user-serviceable parts. Refer servicing to authorized service personnel. CAUTION: 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.
Safety Information 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 Healthcare recommended cables and leadwires.
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.
Safety Information WARNING: EQUIPMENT FAILURE AND HEALTH HAZARDS - Failure on the part of all responsible individuals, hospitals or institutions, employing the use of this system, to implement the recommended maintenance schedule, may cause equipment failure and possible health hazards. The sole responsibility rests with the individuals, hospitals, or institutions utilizing the system.
Product and Packaging Information 3 Product and Packaging Information Hardware Label Locations The following illustrations and table describe the labels and their location on your device and its packaging.
Product and Packaging Information 14 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Product and Packaging Information Table 3: Label Descriptions on the Device and Packaging Item Label Location Description 1 Device Address Back of the Label and Rating device Plate Provides regulatory and cautionary information. See "Device Address Label and Rating Plate" on page 17 for an explanation of the label. 2 Country-specific Label Back of the device Contains registration information for China and Latin America. 3 Serial Number Label Back of the device Identifies this device.
Product and Packaging Information 16 Item Label Location Description 7 Shipping Label On the shipping package Indicates the shipping address where the device is delivered. 8 RED Lable On the shipping package Contains registration information of Radio Equipement Directive. 9 Environmental Symbols These symbols containing warning and caution indicators are required for shipping. For a full description of symbols, see "Symbol Descriptions" on page 18.
Equipment Identification 4 Equipment Identification Serial Number Label The serial number label is in the following format: Table 4: Serial Number Label Format Item Description 1 Product Name 2 Date of Manufacture in YYYY-MM-DD Format 3 Country of Origin 4 Device Serial Number 5 UDI Barcode 6 Product Part Number Device Address Label and Rating Plate The device address label and rating plate is in the following format: 2109599-003 A MAC™ 7 Resting ECG Analysis System 17
Equipment Identification Table 5: Device Address Label and Rating Plate Format Item Description 1 Product name 2 Manufacturer name and address 3 Electrical rating of the device 4 Symbols See "Symbol Descriptions" on page 18 for a description of the symbols used on this label. Symbol Descriptions The following table describes symbols or icons that are on the device or its packaging.
Equipment Identification Symbol Description Batch Code or Lot Number Indicates the manufacturer's batch code or lot number. Date of Manufacture (Year-Month-Date) 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. Rx Only US Federal law restricts this device to sale by or on the order of a physician.
Equipment Identification Symbol Description 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. This Way Up Indicates the correct upright position of the package. Keep Dry Indicates that you need to keep the container away from rain and other sources of moisture. Can Be Recycled Indicates you may recycle this material or device.
Equipment Identification Symbol Description Do Not Stack Indicates that you should not stack the container or place a load on the container. 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. Equipotentiality Connect non-grounded peripheral devices to ensure equipotential.
Equipment Identification Serial Number Format Each device has a serial number that uniquely identifies the device and provides important information about the device. The serial number format is shown in the following illustration: Table 7: Serial Number Format Item Name Description 1 Product Code A three-character code that uniquely identifies the product line. 2 Year Manufactured A two-digit code identifying the year the device was manufactured. Values range from 00 to 99.
Electromagnetic Compatibility (EMC) 5 Electromagnetic Compatibility (EMC) Before installing or using the device or system, be aware of the proximity of known radio frequency (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.
Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration— Electromagnetic Emissions The system described in this document is intended for use in the following specified electromagnetic environment. It is the responsibility of the customer or user to ensure that this system is used in such an environment. Table 8: EMC Emissions Test Emissions Test Compliance Electromagnetic Environment RF emissions (Radiated) Group 1 Class B This device uses RF energy only for its internal function.
Electromagnetic Compatibility (EMC) Table 9: EMC Immunity Test Immunity Test EN60601 Test Level Compliance Level Electromagnetic Environment– Guidance Electrostatic discharge (ESD) ± 8 kV contact ± 15 kV air ± 8 kV contact ± 15 kV air Floors should be wood, concrete, or ceramic tile. If the floors are covered with synthetic material, the relative humidity should be at least 30%.
Electromagnetic Compatibility (EMC) Immunity Test EN60601 Test Level Compliance Level Electromagnetic Environment– Guidance Conducted RF 3 Vrms 0.15 MHz to 80 MHz 3 Vrms 0.15 MHz to 80 MHz Recommended separation distance: 6 Vrms in ISM bands between 0.15 MHz and 80 MHz 6 Vrms in ISM bands between 0.
Electromagnetic Compatibility (EMC) Immunity Test EN60601 Test Level Compliance Level Electromagnetic Environment– Guidance NOTE: • Do not use portable or mobile RF communications equipment closer to any part of the system, including the cables, than the recommended separation distance calculated for the equation applicable to the frequency of the transmitter.
Electromagnetic Compatibility (EMC) Rated Maximum Output Power of Transmitter in Watts (W) Separation Distance (meters) According to Frequency of Transmitter 150 kHz to 80 MHz d (meters) = 3.5/V1 x √ P d (meters) for V1 = 3 Vrms 2 80 MHz to 800 MHz d = 3.5/E1 x √ P d for E1 = 3 V/m 1 800 MHz to 2.5 GHz d = 7/E1 x √ P d for E1 = 3 V/m Meters Feet Meters Feet Meters Feet 10 3.689 12.104 3.689 12.104 7.379 24.208 100 11.667 38.276 11.667 38.276 23.333 76.
Wireless Regulations 6 Wireless Regulations The wireless and wired LAN functionality of the MAC 7 is used to retrieve ECG orders and send ECG reports to an ECG Management System. In addition, the wireless and wired LAN functionality can be used to interface to other hospital information systems to provide additional data to the care giver operating the electrocardiograph. These tasks are an adjunct to the device’s intended use of acquiring, analyzing, displaying and printing an electrocardiogram.
Wireless Regulations can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help.
Wireless Regulations Cet équipement doit être installé et utilisé avec un minimum de 20 cm de distance entre le dispositif et l'utilisateur ou des tiers. Ce dispositif ne doit pas être utilisé à proximité d’une autre antenne ou d’un autre émetteur.
GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: +1 414 355 5000 Tel: +1 800 558 7044 (US Only) GE Medical Systems Information Technologies, Inc., a General Electric Company, going to market as GE Healthcare. www.gehealthcare.
