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© 2012, 2015 General Electric Company.
All Rights Reserved.
Publication Information
The information in this manual applies only to MAC™ i Resting ECG Analysis System version 2. It does not apply to earlier product versions.
Due to continuing product innovation, specifications in this manual are subject to change without notice.
MUSE, CASE, MAC, MARS, 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:
The document part number and revision appear at the bottom of each page. The revision identifies the document’s update level. The
revision history of this document is summarized in the following table.
To access other GE Healthcare manuals, go to the Common Documentation Library (CDL), located at http://www.gehealthcare.com/usen/
service/biomed_tech_selfservice/services_user_doc/products/support.html and click Cardiology.
To access Original Equipment Manufacturer (OEM) manuals, go to the device manufacturer's Web site.
India Headquarters
Wipro GE Healthcare Pvt. Ltd., No.4, Kadugodi Industrial Area, Bangalore – 560 067, Karnataka India
Tel: +91 80 2845 2923/25/26
Fax: +90 80 28452924
Service Contact:
Tel: +91 80 32937750
Toll free number:
1 800 425 7255 (BSNL)
1 800 102 7750 (Airtel)
• Do not attempt to service the equipment unless this service manual has been consulted
and is understood.
• Failure to heed this warning may result in injury to the service provider, operator, or patient,
from electric shock, mechanical or other hazards.
ПРЕДУПРЕЖДЕНИЕ Това упътване за работа е налично само на английски език.
(BG) • Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е
да осигури превод.
警告 本维修手册仅提供英文版本。
ZH-CN • 如果维修服务提供商需要非英文版本,客户需自行提供翻译服务。
• 未详细阅读和完全理解本维修手册之前,不得进行维修。
• 忽略本警告可能对维修人员,操作员或患者造成触电、机械伤害或其他形式的伤害。
警告 本維修手冊只提供英文版。
(ZH-TW) • 如果客戶的維修人員有英語以外的其他語言版本需求,則由該客戶負責 提供翻
譯服務。
• 除非您已詳閱本維修手冊並了解其內容,否則切勿嘗試對本設備進行維 修。
• 不重視本警告可能導致維修人員、操作人員或病患因電擊、機械因素或 其他因素
而受到傷害。
UPOZORENJE Ove upute za servisiranje dostupne su samo na engleskom jeziku.
(HR) • Ukoliko korisnički servis zahtijeva neki drugi jezik, korisnikova je odgovornost osigurati
odgovarajući prijevod.
• Nemojte pokušavati servisirati opremu ukoliko niste konzultirali i razumjeli ove upute.
• Nepoštivanje ovog upozorenja može rezultirati ozljedama servisnog osoblja, korisnika ili
pacijenta prouzročenim električnim udarom te mehaničkim ili nekim drugim opasnostima.
• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a
pochopili jeho obsah.
• Forsøg ikke at servicere udstyret medmindre denne servicemanual har været konsulteret
og er forstået.
• Älä yritä korjata laitteistoa ennen kuin olet varmasti lukenut ja ymmärtänyt tämän
huolto-ohjeen.
• Ne pas tenter d'intervenir sur les équipements tant que le manuel technique n'a pas été
consulté et compris.
• Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό εκτός εάν έχετε
συμβουλευτεί και έχετε κατανοήσει το παρόν εγχειρίδιο σέρβις.
• Εάν δεν λάβετε υπόψη την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός
στο άτομο παροχής σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς
ή άλλους κινδύνους.
• Ezen figyelmeztetés figyelmen kívül hagyása a szerviz ellátó, a működtető vagy a páciens
áramütés, mechanikai vagy egyéb veszélyhelyzet miatti sérülését eredményezheti.
• Reynið ekki að afgreiða tækið nema þessi þjónustuhandbók hefur verið skoðuð og skilin.
• Brot á að sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda eða
sjúklingi frá raflosti, vélrænum eða öðrum áhættum.
PERINGATAN Manual servis ini hanya tersedia dalam bahasa Inggris.
(ID) • Jika penyedia jasa servis pelanggan memerlukan bahasa lain selain dari Bahasa Inggris,
merupakan tanggung jawab dari penyedia jasa servis tersebut untuk menyediakan
terjemahannya.
• Jangan mencoba melakukan servis terhadap perlengkapan kecuali telah membaca dan
memahami manual servis ini.
• Mengabaikan peringatan ini bisa mengakibatkan cedera pada penyedia servis, operator,
atau pasien, karena terkena kejut listrik, bahaya mekanis atau bahaya lainnya.
AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in Inglese.
(IT) • Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente è
tenuto a provvedere direttamente alla traduzione.
• Il non rispetto della presente avvertenza potrebbe far compiere operazioni da cui derivino
lesioni all'addetto, alla manutenzione, all'utilizzatore ed al paziente per folgorazione
elettrica, per urti meccanici od altri rischi.
警告 このサービスマニュアルは英語版しかありません。
(JA) • サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はその業
者の責任で行うものとさせていただきます。
• このサービスマニュアルを熟読し、十分に理解をした上で装置のサービスを
行ってください。
• この警告に従わない場合、サービスを担当される方、操作員あるいは患者が、感電
や機械的又はその他の危険により負傷する可能性があります。
• Jei neatkreipsite dėmesio į šį perspėjimą, galimi sužalojimai dėl elektros šoko, mechaninių
ar kitų paslaugų tiekėjui, operatoriui ar pacientui.
ADVARSEL Denne servicehåndboken finnes bare på engelsk.
(NO) • Hvis kundens serviceleverandør trenger et annet språk, er det kundens ansvar å sørge
for oversettelse.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual de
assistência técnica.
• O não cumprimento deste aviso pode por em perigo a segurança do técnico, operador ou
paciente devido a choques elétricos, mecânicos ou outros.
AVISO Este manual técnico só se encontra disponível em inglês.
(PT-PT) • Se a assistência técnica do cliente solicitar estes manuais noutro idioma, é da
responsabilidade do cliente fornecer os serviços de tradução.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual
técnico.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca ili
pacijenta usled strujnog udara, ili mehaničkih i drugih opasnosti.
VAROVANIE Tento návod na obsluhu je k dispozícii len v angličtine.
(SK) • Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie
prekladateľských služieb je zodpovednosťou zákazníka.
• No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido este
manual de servicio.
• La no observancia del presente aviso puede dar lugar a que el proveedor de servicios, el
operador o el paciente sufran lesiones provocadas por causas eléctricas, mecánicas o
de otra naturaleza.
• Försök inte utföra service på utrustningen om du inte har läst och förstår den här
servicehandboken.
• Om du inte tar hänsyn till den här varningen kan det resultera i skador på serviceteknikern,
operatören eller patienten till följd av elektriska stötar, mekaniska faror eller andra faror.
UYARI Bu servis kılavuzunun sadece İngilizcesi mevcuttur.
(TR) • Eğer müşteri teknisyeni bu kılavuzu İngilizce dışında bir başka lisandan talep ederse, bunu
tercüme ettirmek müşteriye düşer.
CẢNH BÁO Tài Liệu Hướng Dẫn Sửa Chữa chỉ có bản tiếng Anh.
(VI) • Nếu các đơn vị cung cấp dịch vụ cho khách hàng yêu cầu một ngôn ngữ nào khác tiếng
Anh, thì khách hàng sẽ có trách nhiệm cung cấp các dịch vụ dịch thuật.
• Không được sửa chữa thiết bị trừ khi đã tham khảo và hiểu Tài liệu Hướng dẫn Sửa chữa.
• Không tuân thủ những cảnh báo này có thể dẫn đến các tổn thương cho người thực
hiện sửa chữa, người vận hành hay bệnh nhân, do sốc điện, các rủi ro về cơ khí hay
các rủi ro khác.
1 Introduction
Intended User............................................................................................ 13
Contraindiations ....................................................................................... 13
Training ..................................................................................................... 28
Equipment Identification........................................................................... 28
Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Serial Number Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Device Address Label and Rating Plate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Product Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Service Information................................................................................... 31
Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Additional Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2 Product Overview
Hardware Description ............................................................................... 36
Top View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Side View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Blank Display............................................................................................. 84
Printing Errors........................................................................................... 85
Printer Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Data Printing Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Software Kit............................................................................................... 98
A Technical Information
Specifications ............................................................................................ 99
Intended User
The MAC™ i Resting ECG Analysis System is intended to be used by qualified medical
personnel who have received proper medical and product training.
Contraindiations
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
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.
Safety Definition
Convention
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 following messages apply to the system as a whole. Specific messages may also
be provided elsewhere in the manual.
DANGER:
EXPLOSION HAZARD – Use near flammables may cause explosion.
Do not use in the presence of flammable anesthetics, vapors, or liquids.
WARNING:
POSSIBLE ELECTRIC SHOCK – Failure to properly ground the device when
connected to an AC power source could result in an electric shock to the patient or
operator.
When using AC power, the mains plug must be connected to an appropriate
power supply.
Operate the device from its battery if the integrity of the protective earth
conductor is in doubt.
Category Classification
Type of protection against electrical shock Class 1 internally powered equipment
Take care to avoid accidental spills or ingress of materials into the system.
Certification Information
Medical Equipment
Classified with respect to electric shock, fire, mechanical, and other
specified hazards only in accordance with UL 60601-1, CAN/CSA
C22.2 No. 601.1, IEC 60601-2-25, IEC 60601-1, IEC 60601-1-2, IEC
60601-2-51
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.
Device Packaging
NOTE:
This system comes as a single-channel system by default. If you are using it as
a three-channel system, you must activate the three-channel option with the
three-channel option code. Refer to the operator’s manual for instruction on
entering option codes.
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.
Manufacturer
Indicates the name and address for the manufacturer of this device. It
may also include the date it was manufactured.
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.
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).
Symbol Description
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.
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.
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.
Non-ionizing Electromagnetic Radiation
Indicates that the equipment emits elevated, potentially hazardous,
levels of non-ionizing radiation (electromagnetic energy) for diagnosis or
treatment.
Symbol Description
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.
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.
WARNING:
ENVIRONMENTAL OR HEALTH HAZARD
Incinerating the device or product could present a risk to the
environment or human health.
Do not incinerate this device or product.
WARNING:
HAND CRUSHING HAZARD
This device contains moving parts that could crush the user's hand.
Keep hands clear of the device while it is in operation. Disconnect
power before reaching into or servicing the device.
WARNING:
PINCH POINT
This device contains moving parts that could pinch body parts.
Keep hands clear of the device while it is in operation. Disconnect
the power before reaching into or servicing the device.
WARNING:
PERSONAL INJURY DO NOT REACH IN
Reaching into the equipment can cause personal injury.
Do not place hands into any openings.
Symbol Description
WARNING:
BODILY INJURY
Indicates the presence of mechanical parts that can result in
pinching, crushing, or other bodily injury.
To avoid risk of bodily injury, keep away from moving parts.
Disconnect power before reaching into area or servicing.
WARNING:
BODILY INJURY
Indicates the presence of a sharp edge or object that can cause
cuts or other bodily injury.
To prevent cuts or other bodily injury, do not contact sharp edge of
object.
WARNING:
BODILY INJURY
Indicates the presence of a potential tip-over hazard that can result
in bodily injury.
To avoid risk of bodily injury, follow all instructions for maintaining
the stability of the equipment during transport, installation, and
maintenance.
Temperature Limits
Indicates the upper and lower temperature limits for the transportation
and handling of this package. They are indicated next to the upper and
lower horizontal lines.
Can Be Recycled
Indicates you may recycle this material or device. Recycle or dispose of
in accordance with local, state, or country laws.
Symbol Description
Contains <heavy metal chemical symbol>
Indicates this equipment contains heavy metal and must not be
disposed of as unsorted municipal waste but collected separately.
The example shows Lithium Ion.
This Way Up
Indicates the correct upright position of the package.
Do Not Stack
Indicates that you should not stack the container or place a load on
the container.
Keep Dry
Indicates that you need to keep the container away from rain and other
sources of moisture.
Humidity Limits
Indicates upper and lower humidity limits for the transportation and
handling of this package. They are indicated next to the upper and
lower horizontal lines.
Symbol Description
Atmospheric Limits
Indicates the upper and lower barometric pressure limitations for the
transportation and handling of this package. They are indicated next to
the upper and lower horizontal lines.
Rx Only
US Federal law restricts this device to sale by or on the order of a
physician.
The following table describes certification symbols that may be used on your device
or its packaging. The inclusion of a symbol in this table does not indicate that your
product was certified by that symbol’s governing body and is listed for reference
only. To identify which organizations have certified your device, refer to the labeling
on your device or its packaging.
Certification Symbols
Certification Description
Symbol
UL Mark
Indicates compliance with applicable Underwriters Laboratories
requirements.
UL Listed Mark
Indicates compliance with international or regional standards for
Underwriters Laboratories safety requirements.
UL Listed, Canada/US
Indicates compliance with international or regional standards for
Underwriters Laboratories safety requirements in Canada and the
United States.
UL Classification Mark
Indicates this medical equipment is UL Classified with respect to electric
shock, fire, and mechanical hazards only in accordance with UL 60601-1,
CAN/CSA C22.2 NO. 601.1, and IEC 60601-2-25.
UL Classification Mark, Canada/US
Indicates this medical equipment is UL Classified with respect to electric
shock, fire, and mechanical hazards only in accordance with UL 60601-1,
CAN/CSA C22.2 NO. 601.1, and IEC 60601-2-25 for the US and Canada.
CE Mark
Indicates the device or product conforms with applicable EU (European
Union) directives.
PCT (GOST-R) Mark
Indicates the device or product conforms with applicable Russian
Gosstandart technical and safety standards.
Certification Description
Symbol
NRTL Certification
Indicates the device or product has met the National Recognized Testing
Laboratories certification.
The NRTL certification attainted is added to the mark of the applicable
testing laboratory. The example displays the NRTL certification with
the MET Laboratories mark.
China Metrology Certification
Indicates the device or product complies with applicable China
Metrology Certification requirements.
FCC Approval (US only)
Indicates the device or product complies with Federal Communications
Commission Rule Part 18 Subpart B (Section 18.203) – General
information regarding applications and authorizations for industrial,
scientific, and medical (ISM) equipment.
TÜV Rheinland
Indicates the device or product complies with applicable technical
and safety requirements following testing by Technischer
Überwachungs-Verein, (Technical Inspections Organization).
CCC (China)
Indicates the device or product conforms with applicable China
requirements.
Training
This manual is intended as a supplement to, not a substitute for, thorough product
training. If you have not received training on the use of the system, you should request
training assistance from GE Healthcare.
To see available training, go to the GE Healthcare training Web
site (www.gehealthcare.com/training). Select Education>Product
Education-Technical>Diagnostic Cardiology.
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.
Equipment Identification
Every GE Healthcare product has a product label that identifies the product name,
part number, manufacturing information, and unique serial number. This information
is required when contacting GE Healthcare for support.
Product Label
The product label is laid out in the following format. Depending on the product, the
label may vary slightly in format, but it contains the same information.
Item Description
1 Product description
2 Product part number
3 Device serial number (See “Serial Number Format” on page 29 for more
information.)
4 Product bar code
5 Date of manufacture in YYYY-MM format
Item Description
1 Manufacturer name and address
2 Electrical rating of the device
3 Symbols
See“Symbol Descriptions” on page 21 for a description of the symbols used on
this label.
4 Country of origin
5 Product description
Product Codes
The product code identifies specific system platforms.
You can identify the product code using the serial number listed on the product label
located in one of the following places:
• On the product label attached to the device.
• On the product label provided with the application CD.
For software application systems, you can view the serial number by launching the
system application and clicking Help > About.
For information on launching the application, refer to the service or operator's manual
for this system.
Service Information
This section provides information pertaining to the maintenance and servicing of the
system. Familiarize yourself with this information before requesting service from GE
Healthcare or its authorized representatives.
Service Requirements
For systems with hardware provided by GE Healthcare, failure on the part of the
responsible individual, hospital, or institution using this equipment to implement
a satisfactory maintenance schedule may result in equipment failure and possible
safety hazards.
For software only products, maintenance of the hardware and operating system on
which the software resides is the responsibility of the customer.
Regular maintenance, irrespective of usage, is essential to ensure that the components
of this system are always functional when required.
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.
Additional Assistance
GE Healthcare maintains a trained staff of application and technical experts to answer
questions and respond to issues and problems that may arise during the installation,
maintenance, and use of this system.
Contact your local GE Healthcare representative to request additional assistance.
Manual Information
This section provides information for the correct use of this manual.
Keep this manual with the equipment at all times and periodically review it. You
should request training assistance from GE Healthcare, if needed.
Manual Purpose
This manual provides technical information for service representatives and technical
personnel so they can maintain the equipment to the assembly level. It serves as a
guide for maintenance and electrical repairs that are considered field-repairable.
Where necessary, the manual identifies additional sources of relevant information
and technical assistance.
See the operator’s manual of this system for the instructions necessary to operate the
equipment safely in accordance with its function and intended use.
Document Conventions
This manual uses the following conventions.
Typographical Conventions
Convention Description
Bold Text Indicates keys on the keyboard, text to enter, or hardware items such as
buttons or switches on the equipment.
Italicized-Bold Indicates software terms that identify menu items, buttons or options in
Text various windows.
CTRL+ESC Indicates a keyboard operation. A plus (+) sign between the names of two
keys indicates that while holding the first key, you should press and release
the second key. For example, Press CTRL+ESC means to press and hold the
CTRL key and then press and release the ESC key.
<space> Indicates that you must press the spacebar. When instructions are given
for typing a precise text string with one or more spaces, the point where
you must press the spacebar is indicated as <space>. This ensures that
the correct number of spaces is inserted in the correct positions within
the literal text string. The purpose of the < > brackets is to distinguish the
command from the literal text within the string.
Enter Indicates that you must press the Enter or Return key on the keyboard. Do
not type Enter.
> The greater than symbol, or right angle bracket, is a concise method to
indicate a sequence of menu selections.
For example, the statement “From the main menu, select System > Setup >
Options to open the Option Activation window” replaces the following:
1. From the main menu, select System to open the System menu.
2. From the System menu, select Setup to open the Setup menu.
3. From the Setup menu, select Options to open the Option Activation
window.
Illustrations
All illustrations in the manual are provided as examples only. Depending on system
configuration, screens in the manual may differ from the screens on your system.
All patient names and data are fictitious. Any similarity to actual persons is
coincidental.
Notes
Notes provide application tips or additional information that, while useful, are not
essential to the correct operation of the system. They are called out from the body
text through a flag word and indentation, as follows:
NOTE:
The tip or additional information is indented below the NOTE flag word.
Related Documents
The following documents provide additional information that may be helpful in the
installation, configuration, maintenance, and use of this system.
MAC i Configurations
Hardware Description
This section identifies the key components of the MAC i system hardware. Familiarize
yourself with these components, their location, and their use before attempting
to use the system.
Top View
Side View
Rear View
Keypad
Keypad
Keypad (cont'd.)
System Overview
The MAC i Resting ECG System is a 12-lead, 3-channel system with a 2-line x 16
character display and passive patient cable.
Mechanical Structure
The major mechanical components of the MAC i device are at the top and bottom
covers with the following sub assemblies:
• PCB assembly mounted over the bottom cover
The display connector, keypad connector, printer connector, and patient cable
connector are mounted to the PCB assembly.
• Battery pocket, battery cover, and battery
• Thermal printer, paper pocket, and printer door
• The display window and keypad are housed in the top cover and linked to the main
PCB assembly through flexible cables.
Functionality
The following block diagram details the main PCB assembly containing all of the
circuitry for the MAC i Resting ECG System. The AC/DC switching power supply, battery,
thermal printer, keypad, and display are not on the main PCB assembly. The PCB
assembly is divided into two sections: isolated and non-isolated.
Item Description
Input voltage range 100-240V ±10% AC
Frequency 47-63 Hz
Full load output current 1.5A
Output voltage 12V
Line regulation ±1%
Load regulation ±5%
DC Power Inlet
The power inlet to the device is through a miniature right angle power jack located
on the PCB assembly at the rear of the device. You can connect the output AC/DC
adaptor directly to the jack provided on the device. This jack is designed to fit the
AC/DC adaptor recommended by GE Healthcare. Other types of AC/DC adaptors may
cause permanent damage or inferior performance of the system.
Battery
A customized, rechargeable Lithium-Ion battery with built-in 2S protection is mounted
to the battery pocket on the bottom cover. Use the dedicated battery charger to
charge the battery. The battery specifications are listed in the following table:
Battery Specifications
Item Description
Rated voltage 7.2V
Battery voltage 5.4–8.4V
Display
The alphanumeric interface displays on a 16 x 2 character liquid-crystal display
powered by a +5V power supply.
Printer Options
The MAC i is available in two printer configurations:
• 58 mm (two–inch) printer
This configuration delivers the following:
• A single–channel recording and an optional three–channel recording in ECG
mode.
• A single–channel recording in rhythm mode.
• 80 mm (three–inch) printer
This configuration delivers the following:
• A three–channel recording in ECG mode.
• A single–channel recording in rhythm mode.
• A three-channel recording in rhythm mode.
The three–channel configuration has an option for both roll and z-fold paper. The
z-fold paper is included in the accessory kit. If you prefer to use roll paper, you
may order it separately. For ordering information, refer to the MAC i Supplies and
Accessories Reference Guide.
configuration, and the three–inch printer setting when you are using a three-channel
configuration.
The switch setting for each configuration is described in the following tables.
Switch Number: 1 2 3
Switch Position: Away from the Toward the number Toward the number
number
Switch Number: 1 2 3
Switch Position: Toward the number Away from the Away from the
number number
Programming complete
NOTE:
If Boot SW can also updated from the software currently in the device, the
system displays the following message on the screen: Update Boot SW.
1. Press Enter to program Boot.
Do not remove the SD card until programming is completed.
2. After programming is completed, remove the SD card and restart the
system for normal operation.
6. If any error messages are displayed, please correct the errors based on the
message displayed and press Enter to restart programming.
To exit programming during error conditions, press Start/Stop to return to the
Startup screen.
If you are not updating the boot software, reattach the top cover and complete the
“Software Functional Checkout Procedures” on page 76.
If you are updating the boot software at this time, proceed to “Updating the Boot
Software” on page 46.
Display Test
Use the following procedure to complete the Display test.
1. Select the Display test and press Enter to start the test.
2. Press the right or up cursor key.
Two rows of 16 black squares are displayed on the screen.
3. Press the left or down cursor key to clear the display.
4. Press Enter to exit and move to the next test
If the display test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.
Keypad Test
Use the following procedure to complete the Keypad test.
1. Select the Keypad test and press Enter to start the test.
2. Press each key on the keypad in sequence.
The corresponding name for the key is displayed on the screen. Refer to the
following table for the corresponding name of the key.
If the keypad test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.
Writer Tests
Use the following procedure to complete the writer tests.
1. Select the Writer test and press Enter to start the test.
2. Press the up or down cursor key to select the speeds: 5, 25 or 50 mm/s.
3. Press Enter to begin printing a scale of 1 mm and another scale of 25 mm on
the bottom edge of the paper, as seen in the following example:
The same pattern is printed at all speeds: 5, 25, and 50 mm/sec.
Roller Test
The printout should have uniformly placed slanted parallel lines. If white spots
are observed in the printout, repeat this step three times. We recommend
replacing the printer if you continue to observe the white spots.
6. Press the up or down cursor key to select Exit.
7. Press Enter to exit and return to the Device Test menu.
If the writer test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.
Battery Test
Use the following procedure to complete the battery test.
1. Select the Battery test and press Enter to start the test.
The battery voltage is displayed.
2. Press Enter to exit the battery test and proceed to the Acq. Test.
If the battery test does not pass, see “Troubleshooting” on page 79 to diagnose and fix
the problem.
Acquisition Test
Use the following procedure to test the acquisition cable connectivity:
1. Connect the patient cable with all of the leads shorted to the lead RL.
2. Load the printer with paper.
3. Press Enter to start the Acq. Test.
The following message is displayed: Connect all leads to RL.
4. Press Enter to start acquiring the data.
The following message is displayed: Acq. Test Acquiring Data.
The result of the test is printed. Leads I, II, and V1 to V6 are printed. This confirms
the acquisition cable connectivity of all 10 leads except RL.
If the acquisition test does not pass, see “Troubleshooting” on page 79 to diagnose
and fix the problem.
System Info
Use the following procedure to access and review the system information.
1. Select System Info and press Enter.
The system prints the following information:
• Serial Number of the device
• ARM software version
• PSoC software version
When System info is displayed, press Enter.
NOTE:
The ARM software version displayed is the MAC i system application software
version. The PSoC software version displayed is the version of the programmed
controller on the board.
Perform the tests under normal, ambient conditions of temperature, humidity, and
pressure with line voltage.
The leakage currents correspond to 110% of the rated voltage for the tested unit. If
this is not taken into account when performing the leakage tests, you must calculate
the measured values.
Confirm that the current leakage test results meet the requirements. All indicated
electrical safety checks require a pass/fail indication for the steps performed. Record
the measurement values in your debrief.
You need to conduct the following safety tests:
• “Enclosure (Chassis) Leakage Current Test” on page 53
• “Patient Leakage Current Tests” on page 54
Complete the electrical safety tests according to the following recommended
schedule:
• After initial setup
• Once every 12 months after setup as part of a regular maintenance plan
• Whenever power sources are affected by servicing
The following electrical diagram shows the Measuring Circuit [M], required for leakage
current. The reading in mV corresponds to mA (leakage current). The safety tester
instruments generally work with this Measuring Circuit [M] and the displayed values
are converted to leakage current.
During NC, take measurements under the following conditions (refer to the safety
tester diagram):
• Device in “ON” state
• Polarity switch at NORM and RVS
• GND switch GND closed
• S1 (neutral) closed
During SFC, take measurements under the following conditions (refer to the following
safety tester diagram):
• Device in “ON” state
• Polarity switch NORM and RVS
• GND switch closed, S1 (neutral) open
• GND switch closed, S1 (neutral) closed
The test has failed if the measured values are greater than those in the following table:
NC SFC
Polarity: NORM & RVS Polarity: NORM & RVS
S1 (neutral): closed S1 (neutral): closed I open
GND: closed GND: open I closed
Total tests/combinations: 2 Total tests/combinations: 2
100 µA (IEC & UL) 500 µA (IEC)
300 µA (UL)
During NC, take measurements under the following conditions (refer to the safety
tester diagram):
• Device in “ON” state
• GND switch GND closed
• Polarity switch NORM and RVS
• S1 (neutral) closed
During SFC, take measurements under the following conditions (refer to the safety
tester diagram):
• Device in “ON” state
• Polarity switch NORM and RVS
The test has failed if the measured values are greater than those in the following table:
NC SFC
N/A Polarity: NORM & RVS
S1 (neutral): open
GND: Closed
Total tests/combinations: 0 Total tests/combinations: 2
N/A 50 µA (IEC & UL)
After completing this test, disconnect the safety tester from line voltage before
disconnecting the patient cable or test plug and the device.
GE Healthcare does not recommend any Preventive Maintenance for this system.
Preventive Maintenance may be performed by the user.
The user may perform the following on their system:
• Recommended Maintenance
• Diagnostic Tests
• Electrical Safety Tests
If further technical assistance is required, contact the nearest GE Healthcare Service
Center.
WARNING:
EQUIPMENT FAILURE/HEALTH RISK — Failure to implement the recommended
maintenance schedule may cause equipment failure and possible health hazards.
All individuals who use this device assume the responsibility for performing the
recommended maintenance, unless an Equipment Maintenance Agreement exists.
Recommended Maintenance
This section contains instructions for the following recommended maintenance:
• Inspection and cleaning
• Visual inspection
• Exterior cleaning
• Interior cleaning
• Printhead cleaning
• Battery Maintenance
• Calibration Check
Visual Inspection
• Check that the patient cable and lead wires are not defective or broken.
• Check that the electrodes are not out of date.
• Inspect the cords and cables for fraying or other damage.
• Ensure the display is mounted correctly, and check for any cracks or damage on
the display.
• Inspect the keys and keypad to make sure they have correct markings on them
and to ensure proper operation.
• Confirm the green LED is a steady light when the device is connected to an external
power adaptor plugged into an AC line and the AC switch is on.
• Check that the printer cable is properly inserted in connector J5. See “Main PCB
Assembly” on page 40 for details on the PCB.
• Check for loose or missing screws on the entire system assembly.
Exterior Cleaning
Clean and disinfect exterior surfaces monthly, or more often as needed. Use the
following procedure to clean exterior surfaces:
1. Use a clean, soft cloth and an agent or disinfectant that contains alcohol and is
commonly used in hospitals.
NOTE:
Do not use disinfectants with a phenol base or peroxide compounds.
2. Wring excess water/solution from the cloth. Do NOT drip water or any liquid on
the system, and avoid open vents, plugs, or connectors.
3. Dry surfaces with a clean cloth or paper towel.
Interior Cleaning
Check for dust on the interior components and clean as needed with commercially
available compressed air.
Printhead Cleaning
Clean the thermal printhead periodically to ensure good print quality and long printer
life.
Observe the following precautions when cleaning the printhead:
• Do not hit the thermal printhead with anything hard.
• Do not use sand paper on the thermal printhead.
• Do not use unnecessary force on the thermal printhead.
NOTE:
Use a disposable wrist strap to avoid static electricity.
Battery Maintenance
The battery has a shelf life of six months. Recharge the battery once every six
months if it is stored for a long period of time. The system can print only when
the battery is connected to the device. With a fully charged battery (8.3–8.4V) you
can print approximately 250 ECG reports continuously in sequential single-lead or
simultaneous three–lead format at a speed of 25 mm/sec and gain of 10 mm/mV
without measurement enabled.
NOTE:
If the device cannot produce at least 100 ten-second ECG reports in simultaneous
format on a fully charged battery, replace the battery. For instructions on
replacing the battery, see “Replacing the Battery” on page 62.
For maximum battery life, and to avoid low battery shutdown, charge the battery
when the low battery condition is indicated. For details, refer to System LEDs in
the MAC™ i Resting ECG System Operator’s Manual).
Keeping the battery idle for more than six months may reduce the battery
life. System specification and performance is guaranteed only with a battery
recommended by GE Healthcare.
Calibration Check
Complete a regular calibration check of the system once a year.
Use the following procedure to check calibration of the system:
1. Turn on the system.
2. Connect the patient cable to the system.
3. Take a rhythm printout in default settings for each lead:
a. Start a Rhythm recording.
b. Wait for 2 to 3 seconds.
c. Stop the recording.
4. Ensure that the calibration pulse for all leads is 5 mm ±5% in width and 10 mm
±5% in height.
Safety Instructions
The following considerations apply when repairing the system:
• Only authorized, trained personnel may conduct repairs.
• Before opening the device, turn off the power and disconnect the external power
supply from the unit.
• Before opening the device or completing any servicing, remove the battery.
• Use only the original GE Healthcare FRUs identified in the FRU list.
• When replacing electronic components, implement ESD protection.
• Dispose of defective or empty Li-ion batteries in accordance with the applicable
legal regulations in your country or return them to the factory.
NOTE:
Use necessary personal protective equipment (PPE) while performing maintenance
on the device.
After completing any FRU replacement, conduct a thorough visual inspection of the
system. For more information, see “Visual Inspection” on page 60.
No special tools are needed to perform the following functional checkout procedures.
1. Perform a Calibration Check.
See “Calibration Check” on page 61 for more information.
2. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
3. Verify that the Battery Test was successful.
Refer to “Battery Test” on page 52.
Use the following procedure to remove the top cover of the device:
Item Description
1 Key sheet flex cable
2 Fastening screws (4)
Use the following procedure to remove the bottom cover of the device:
4. Verify ECG printing in default ECG mode and in Rhythm mode by connecting the
device to a 12–lead simulator.
Refer to the MAC™ i Resting ECG System Operator’s Manual for details on
printing ECGs.
5. Verify that all options are restored successfully. Use the following procedure
to check the options:
Option Task
MEAS (measurement option) Take a 10–second ECG in any report format and
ensure that the measurement page is printed at the
end of the report.
3LRF (3–Lead Report Format Ensure that four report formats (SIM3, SEQ3, SEQR,
option) and SIML) are available in the ECG mode.
DIAG (interpretation option) Take a 10–second ECG in any report format and
ensure that the interpretation page is printed at the
end of the report.
6. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the device is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
7. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
8. Conduct the following tests and verify they are successful:
• Display Test (see “Display Test” on page 49).
• Keypad test (see “Keypad Test” on page 50).
• Writer tests (see “Writer Tests” on page 50).
• Battery tests (see “Battery Test” on page 52).
• Acquisition Module tests (see “Acquisition Test” on page 52).
• System Info (see “System Info” on page 52).
• Enclosure Leakage Current Test (see “Enclosure (Chassis) Leakage Current
Test” on page 53).
• Patient Leakage Current-to-Ground Test (see “Patient Leakage
Current-to-Ground Test” on page 55).
Item Description
1 Printer door with Printer Roller
2 Printer
3 Screws fastening the base of the printer to the printer mounting base
4 Connector J5 and the flat ribbon printer cable
The following procedures explain how to replace the printer and complete the
functional checkout after replacing this FRU.
Replacing the Printer Kit
Item Description
1 Fastening screws (2)
2 Display module
Item Description
1 Fastening screws (4)
2 Printer cable
11. Replace the battery in the battery pocket and slide on the battery cover.
12. Turn on the device and enter the settings.
For more information on entering settings, refer to the MAC™i Resting ECG
Analysis Operator’s Manual.
13. Enter the serial number and option codes (optional) as necessary.
This should restore the previous user settings.
• If you do not know the serial number, contact GE Healthcare Service.
• If you do not know the option code, refer to “Setting up the System for
Operation” in the MAC™i Resting ECG System Operator’s Manual.
• If the previous user settings are not restored, select the default settings.
Functional Checkout Procedures (Main PCB Assembly)
5. Verify that all options are restored successfully. Use the following procedure
to check the options:
Option Task
MEAS (measurement option) Take a 10–second ECG in any report format and
enabled ensure that the measurement page is printed at the
end of the report.
3LRF (3–Lead Report Format Ensure that four report formats (SIM3, SEQ3, SEQR,
option) and SIML) are available in the ECG mode.
DIAG (interpretation option) Take a 10–second ECG in any report format and
enabled ensure that the interpretation page is printed at the
end of the report.
6. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the unit is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
7. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
8. Perform the following tests and verify they are successful:
• Display Test (see “Display Test” on page 49).
• Keypad test (see “Keypad Test” on page 50).
• Writer tests (see “Writer Tests” on page 50).
• Battery tests (see “Battery Test” on page 52).
• Acquisition Module tests (see “Acquisition Test” on page 52).
• System Info (see “System Info” on page 52)
• Enclosure Leakage Current Test (see “Enclosure (Chassis) Leakage Current
Test” on page 53).
• Patient Leakage Current to Ground Test (see “Patient Leakage
Current-to-Ground Test” on page 55).
You need a Safety Tester for measurements (that complies with 60601–1) to complete
the checkout procedures.
74 MAC™ i Resting ECG Analysis System 2065935-002D
Maintenance and FRU Replacement Procedures
Use the following procedure to complete the functional checkout for this FRU
replacement:
1. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the unit is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
2. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
3. Perform the following tests and verify they are successful:
• Enclosure Leakage Current Test (see “Enclosure (Chassis) Leakage Current
Test” on page 53).
• Patient Leakage Current to Ground Test (see “Patient Leakage
Current-to-Ground Test” on page 55).
4. Verify that all options are restored successfully. Use the following procedure
to check the options:
If the following option is Do the following…
enabled…
MEAS (measurement option) Take a 10–second ECG in any report format and
ensure that the measurement page is printed at the
end of the report.
3LRF (3–Lead Report Format Ensure that four report formats (SIM3, SEQ3, SEQR,
option) SIML) are available in the ECG mode.
DIAG (interpretation option) Take a 10–second ECG in any report format and
ensure that the interpretation page is printed at the
end of the report.
5. Verify that the external power LED on the keypad is a steady green when the
external power supply is connected to the unit.
This LED must be a steady green whether the unit is in the Off or On condition.
Refer to “Keypad” on page 37 for the location of the LED.
6. Verify the battery charging progress by checking the status of LED DS2 and
DS5 on the PWA.
See “Voltage Supply and Monitoring” on page 41 for more information.
7. Perform the following tests and verify they are successful:
• Display Test (see “Display Test” on page 49).
• Keypad test (see “Keypad Test” on page 50).
• Writer tests (see “Writer Tests” on page 50).
• Battery tests (see “Battery Test” on page 52).
• Acquisition Module tests (see “Acquisition Test” on page 52).
• System Info (see “System Info” on page 52)
Adjustment Instructions
This system does not require any component adjustments.
Power Errors
Errors may occur concerning the external and battery power.
In the following list, identify the error that best describes the conditions you have
observed. Follow the steps outlined in the flowchart to pinpoint the faulty component.
• The Device Does Not Turn On
• “The External Power LED is On” on page 80
• “The External Power LED is Not On” on page 81
• Battery Errors
• “Device Does Not Turn On in Battery Only Connection” on page 82
• “Battery Error Message is Displayed” on page 83
Battery Errors
Identify the error that best describes the conditions you have observed and use the
flowchart to locate the problem.
Device Does Not Turn On in Battery Only Connection
This system prints and records ECGs only in battery mode operation with the external
power supply cord disconnected from the device. If the device does not turn on, use
the following flowchart to diagnose the problem. For information on how to replace
components, see “Replacing Field Replaceable Units (FRUs)” on page 62.
Blank Display
If the device is on and the ON/OFF LED is steady green on the keypad but the display is
blank, use the following flowchart to pinpoint the faulty component. For information
on how to replace components, see “Replacing Field Replaceable Units (FRUs)” on
page 62.
Printing Errors
The following list is several printing-related errors that can occur:
• Printer Error Messages
• “Door Open” on page 86
• “Paper Error” on page 87
• Data Printing Errors
• “Paper is Moving but Not Printing” on page 88
• “Data Does Not Print on the Upper or Lower Edges of the Paper” on page 89
• “Printing Only Baselines” on page 89
Door Open
The thermal printer has a micro-switch that detects when the printer door is closed. If
the door is open, you receive the following message: Door Open. Use the following
flowchart to diagnose the problem. For information on how to replace components,
see “Replacing Field Replaceable Units (FRUs)” on page 62.
Paper Error
When a problem occurs with the thermal paper, the following error message is
displayed: Paper Error. Use the following flowchart to diagnose the problem. For
information on how to replace components, see “Replacing Field Replaceable Units
(FRUs)” on page 62.
Data Does Not Print on the Upper or Lower Edges of the Paper
If the printer is not printing on one or more edges of the paper, use the following
flowchart to determine why the printing is incomplete. For information on how to
replace components, see “Replacing Field Replaceable Units (FRUs)” on page 62.
This chapter identifies the available Field Replaceable Units (FRU) using illustrations
and part numbers. FRUs fall into three categories: stand-alone FRUs, FRU kits, and
assemblies. You can order any stand-alone FRU, FRU kit, or assembly using the part
numbers provided in this chapter. To order FRUs, contact GE Healthcare Service or an
approved GE Healthcare vendor.
Printer Kit
Item Description
Hardware Kit
Hardware Kit MAC i (PN 2047367-001)
PWA Kit
Battery Kit
Item Description
1 Battery (Lithium Ion)
Battery Cover
Software Kit
Software Kit MACi v2.00 SP1 (PN 2066452-001)
Item Description
CARD SECURE DIGITAL - 2GB
SW CODE MAC i v2.0
LABEL SD CARD FOR MAC i Software Kit
Item Description
CARD SECURE DIGITAL - 2GB
SW CODE MAC i v2.00 SP2
LABEL SD CARD FOR MAC i Software Kit
Item Description
PWR SPLY MEDICAL CLASS I
Specifications
Processing
Element Specifications
Acquisitions 12–lead simultaneous ECG acquisition
Digital sampling rate 2000 samples/second/channel
Acquisition mode 10 seconds of simultaneous and sequential ECG recording
Computerized Supports Measurement with Marquette™ 12SL™ ECG Analysis
measurements Program (optional feature)
Interpretation Supports Interpretation with Marquette™ 12SL™ ECG Analysis
Program (optional feature)
ECG analysis frequency 500 samples/second/channel
Dynamic range AC differential ±5 mV,
DC offset ±300 mV
Resolution 4.88 µV/LSB @ 500 sps
Frequency response –3 dB @ 0.01 to 150 Hz
Low cutoff frequency 0.01 Hz
0.02 Hz
0.16 Hz
0.32 Hz
High cutoff frequency 150 Hz
40 Hz
20 Hz (if the muscle filter is enabled)
Operating modes Automatic ECG (12–lead data)
Rhythm/Manual (real-time data)
Common mode rejection >100 dB (with AC filter enabled)
Input impedance >10M Ohm @ 10 Hz (defibrillator protected)
Processing (cont'd.)
Element Specifications
Patient leakage <10 µA in normal condition
<50 µA in single fault condition
Lead-fail indication Disconnected lead detection. Each single electrode is
monitored except N/right leg.
Heart rate meter 30 to 300 BPM ±10% or ±5 BPM, whichever is greater
Heart rates outside 30 to 300 BPM are not displayed.
Startup time 7 seconds
Display
Element Specifications
Display type 2 x 16 alphanumeric display with adjustable contrast
Display data Operating Mode
Heart rate
Print formats/Lead display
Speed
Gain
Muscle filter
AC filter
Configuration menu
Report Format
Element Specifications
Lead sequence Standard
Cabrera
Writer
Element Specifications
Writer technology Thermal dot array printhead
Writer speed 5 mm/s
25 mm/s
50 mm/s
Number of traces Available in single-channel and three-channel
Writer sensitivity/gain 2.5 mm/mV
5 mm/mV
10 mm/mV
20 mm/mV
Writer speed accuracy ±5%
Writer amplitude accuracy ±5%
Paper size 58 mm roll paper (for single-channel configuration)
80 mm roll paper (for three–channel configuration)
80 mm Z-fold (for three–channel configuration)
Writer speeds accuracy ±5%
Writer (cont'd.)
Element Specifications
Writer amplitude accuracy ±5%
Writer resolution Horizontal 40 dots/mm @ 25 mm/s
vertical 8 dots/mm
Keypad
Element Specifications
Type Membrane keyboard with tactile feedback
Software Standard
Element Specifications
Resting ECG mode Records and prints 12-lead resting ECGs with 10 seconds
duration as a standard feature
Language support English
Software Options
Element Specifications
Measurement Supports measurement with Marquette™ 12SL™ ECG analysis
program:
• Vent. Rate
• P duration
• PR interval
• RR Interval
• QRS duration
• QT/QTc
• P-R-T axes
Three–channel printing Supports three-channel printing in Automatic ECG mode:
• three-lead Simultaneous
• three-lead Sequential
Interpretation Supports interpretation with Marquette™ 12SL™ ECG analysis
program
Power Supply/Electrical
Element Specifications
Power supply External AC/DC adaptor
Ratings/Input voltage 100V to 240V ±10%
Element Specifications
Input current Maximum 0.5A @ 100–240 VAC
Operating frequency 50 Hz to 60 Hz ±3 Hz
Output voltage 12V ±5%
Battery
Element Specifications
Battery type Replaceable and rechargeable Lithium-Ion 7.2V
Battery charge time Approximately 3 hours
Battery charging Automatic battery charging through a built-in charger during
line-power operation
Battery capacity* 7.2V typical, 2.25 AH ±10%
250 continuous ECGs in Sequential single–lead report format
at 25 mm/s and 10 mm/mV
250 continuous ECGs in Simultaneous three–lead report format
at 25 mm/s and 10 mm/mV
Minimum 120 minutes of continuous rhythm print at 25 mm/s
and 10 mm/mV
*These are for a fully-charged battery.
Physical
Element Specifications
Width Approximately 85 mm
Height Approximately 275 mm
Depth Approximately 215 mm
Weight Approximately 1.2 Kg (including battery and paper roll)
Environmental
Element Specifications
Operating Transport/Storage
Temperature 5° to 40°C (41° to 104°F) -15°C to +50°C (5° to 122°F)
Humidity 25% to 95% RH non-condensing 25% to 95% RH non-condensing
Pressure 710 hPA to 1060 hPA 500 hPA to 1060 hPA
Accessories
• Value reusable IEC/AHA limb clamps and bulb electrodes (user selectable)
• Value-fixed, 10-lead patient cable IEC/AHA (user selectable)
• External medical-grade power supply
• 58 mm standard roll paper
102 MAC™ i Resting ECG Analysis System 2065935-002D
Technical Information
Code Description
MDD Class IIa Medical Device Classification for CE marking
IEC 60601-1 General requirements for safety
IEC 60601-1-2 General requirements for safety – electromagnetic
compatibility
IEC 60601-1-4 General requirements for safety – programmable electrical
medical systems
IEC 60601-2-25 Particular requirements for the safety of electrocardiographs
IEC 60601-2-51 Particular requirements for safety, including essential
performance, of recording and analyzing single-channel and
multi-channel electrocardiographs
IEC 60601-1-6 General requirements for basic safety and essential
performance – Collateral Standard: Usability-Edition 2.0
UL 60601–1 Medical electrical equipment, part 1: General Requirements
for Safety
CAN/CSA C22.2 No. General requirements for safety
601.1–M90
ANSI/AAMI EC-11 American National Standard Diagnostic Electrocardiography
Devices
ANSI/AAMI EC-13 American National Standard for cardiac monitors, heart rate
meters, and alarms (Section 4.2.7 Range and accuracy of heart
rate meter)
Fast Transient Surge (FTS) 1 kV line(s) to line(s) Mains power should be that
IEC61000–4–5 of a typical commercial or
hospital environment.
Voltage dips, short <5% Ut (>95% dip in Ut) for Mains power should be that
interruptions, and voltage 0.5 cycles of a typical commercial or
variations on power supply 40% Ut (60% dip in Ut) for 5 hospital environment.
input lines cycles If the user requires continued
IEC 61000–4–11 70% Ut (30% dip in Ut) for 25 system operation during
cycles power mains interruptions,
<5% Ut (>95% dip in Ut) for 5 it is recommended that
sec. the system is powered
from an applicably rated
uninterruptible power supply
or a battery.
NOTE:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is
affected by the reflection from structures, objects, and people.
• aField strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters,
consider conducting an electromagnetic site survey. If the measured field
strength in the location in which the system is used exceeds the applicable
RF compliance level listed in this table, observe the system to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the system.
• bOver the frequency range 150 KHz to 80 MHz, field strengths should be less
than 3 V/m.
A typographical 32
Cover Bottom Kit FRU 97
accessing System Info 47
Cover Top Assembly Kit FRU 96
accessories specifications 102
acquisition test 52
application software D
updating 45 DC power inlet 40
Assistance 31 device
symbols 21
B diagnostic tests 49
display connector location 40
battery Display Module Kit FRU 94
charging conditions 41 display panel 36
specifications 40 display specifications 100
battery connector 41 display test 49
battery specifications 102 document
battery test 52 part number 2
biocompatibility statement 17 revision 2
block diagram 38 document conventions 31
boot software documents
updating 46 related 33
C E
class B equipment 106 ECG
classification signal input connector 36
medical device 15 ECG cable connector location 41
Common Documentation Electrical Fast Transient/
Library (CDL) 2 burst (EFT)
compatibility EMC immunity test 106
electromagnetic 105 electrical specifications 101
EMC 105 electromagnetic
compliance 2 emissions
conducted RF guidance and
EMC immunity test 107 manufacturer’s
connector declaration 105
display 40 immunity
Keypad 41 guidance and
printer cable 40 manufacturer’s
SD card 40 declaration 106107
contraindications 13 separation distances 108
conventions electromagnetic
document 31 compatibility 105
illustrations 32 electrostatic discharge (ESD)
Notes 32 EMC immunity test 106
safety 14 EMC 16
110 MAC™ i Resting ECG Analysis System 2065935-002D
floor composition 106 G
mains power 106 GE Healthcare
separation distances 108 Common Documentation
EMC compatibility 105 Library (CDL) 2
EMC emissions test manuals 2
flicker emissions 106 guidance and
harmonic emissions 106 manufacturer’s
RF emissions declaration
conducted 105 electromagnetic
radiated 105 emissions 105
voltage fluctuation 106 guidance and
EMC immunity test manufacturer’s
conducted RF 107 declaration
Electrical Fast Transient/ electromagnetic
burst (EFT) 106 immunity 106
electrostatic discharge guidance and
(ESD) 106 manufacturer’s
Fast Transient Surge (FTS) 106 declaration
Power frequency (50/ electromagnetic
60 Hz) magnetic field 107 immunity 107
radiated RF 107
short interruptions on
power supply input lines 106 H
voltage dips on power Hardware Kit FRU 93
supply input lines 106 harmonic emissions test 106
voltage variations on
power supply input lines 106
EMI 16 I
environmental identification
specifications 102 equipment 28
equipment illustration conventions 32
identification 28 indications for use 13
external power connector 37 ingress protection 15
external power supply 39 instrument type 99
intended user 13
interface
F printer and motor
Fast Transient Surge (FTS) assembly 42
EMC immunity test 106
flicker emissions test 106 K
FRUs
Cover Battery 97 keypad 36
Cover Bottom Kit 97 arrowpad 38
Cover Top Assembly Kit 96 battery charging LED 37
Display Module Kit 94 ECG key 38
Hardware Kit 93 enter key 38
Plastic Parts Kit 95 external power LED 37
Power Supply Kit 98 lead key 38
Printer Door Kit 93 mode key 38
Printer Kit 92 on/off key 37
PWA Kit 94 on/off LED 38
Software Kit 98 start/stop key 38
keypad connector location 41
keypad specifications 101
2065935-002D MAC™ i Resting ECG Analysis System 111
keypad test 50 printer and motor assembly
interface 42
printer cable connector
L location 40
labeling Printer Door Kit FRU 93
package 18 Printer Kit FRU 92
product 18 processing specifications 99
product
codes 30
M labeling 18
manufacturer programming the device 47
responsibilities 18 protection
mechanical components ingress 15
location 38 purchaser/customer
medical device responsibilities 18
classification 15 PWA connector details 40
PWA Kit FRU 94
N
navigating R
Service Menu 44 radiated RF
Notes conventions 32 EMC immunity test 107
Radio Frequency (RF)
cautions 16
O devices 16
OEM 2 related documents 33
Original Equipment report format specifications 100
Manufacturer (OEM) 2 requirements
service 31
responsibilities
P manufacturer 18
package purchaser/customer 18
labeling 18 revision history 2
packaging RF emissions test
symbols 21 conducted 105
part number radiated 105
document 2
PCB assembly 38
PWA connector details 40 S
physical specifications 102 safety
Plastic Parts Kit FRU 95 conventions
Power frequency (50/ definitions 14
60 Hz) magnetic field hazards 14
EMC immunity test 107 safety and regulatory
power inlet specifications 103
DC 40 SD card connector location 40
power jack connector 40 separation distances
power supply electromagnetic 108
external 39 EMC 108
specifications 39 service
Power Supply Kit FRU 98 information 31
power supply specifications 101 requirements 31
prescription device service menu 44
statement 13 Service Menu
112 MAC™ i Resting ECG Analysis System 2065935-002D
navigating 44 V
short interruptions on
voltage
power supply input lines
supply and monitoring 41
EMC immunity test 106
voltage dips on power
Software Kit FRU 98
supply input lines
software options
EMC immunity test 106
specifications 101
voltage fluctuation
software standard
emissions test 106
specifications 101
voltage variations on power
specifications
supply input lines
accessories 102
EMC immunity test 106
battery 40, 102
display 100
electrical 101 W
environmental 102
keypad 101 warranty information 31
physical 102 writer specifications 100
power supply 39, 101 writer tests 50
processing 99
report format 100
safety and regulatory 103
software options 101
software standard 101
writer 100
storing
system log 46
symbols
device 21
packaging 21
system info 52
System Info
accessing 47
system log
storing 46
T
tests
acquisition 52
battery 52
diagnostic 49
display 49
keypad 50
writer 50
training 28
typographical conventions 32
U
updating
application software 45
boot software 46
GE Medical Systems Information Technologies, Inc., a General Electric Company, going to market as
GE Healthcare.
www.gehealthcare.com