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Philips Trim 1 Service Manual

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    Chapter 1Introduction
    This PageWriter Trim I, II, III, Rx Cardiograph Service Manual provides the information you 
    need to successfully service the PageWriter Trim cardiographs with software version A.01.03 
    and higher. The PageWriter Trim Cardiograph product family includes the following four 
    product models as described in Table 1-1.
    This Service Manual includes information on:
    „Theory of operation
    „Maintenance procedures
    „Performance verification and safety testing
    „Repairs
    „Ordering parts and supplies
    „Specifications
    „Maintenance tests
    „Software Installation 
    „Wireless LAN Installation
    „Upgrade Kit Installation
    Before servicing the PageWriter Trim cardiographs, review the PageWriter Trim Instructions 
    for Use located on the User Documentation CD shipped with the cardiograph, or download the 
    file from the Philips InCenter site (
    incenter.medical.philips.com). For information on accessing 
    the InCenter site, see “Using the Philips InCenter Site” on page 1-26. This service manual 
    assumes you are familiar with the controls, basic cardiograph operations, and capabilities of 
    the device as described in these documents.
    Table 1-1 PageWriter Trim Product Model Information
    PageWriter Trim model Philips Part Number
    PageWriter Trim III860286
    PageWriter Trim II 860288
    PageWriter Trim I860290
    PageWriter Trim Rx  860297 
    						
    							IntroductionWho Should Use this Manual
    1-2PageWriter Trim Cardiograph Service Manual
    Who Should Use this Manual 
    This manual is intended for users who handle preventive maintenance, periodic operational 
    checks, and basic troubleshooting for PageWriter Trim cardiographs.
    Before attempting to service the cardiographs, you must review the following documentation 
    and training materials:
    „PageWriter Trim Instructions for Use 
    „PageWriter Trim Cardiograph Interactive Training Program
    „This Service Manual
    This PageWriter Trim Cardiograph Service Manual is intended to assist users in the safe and 
    effective use of the product.
    Before attempting to operate this product, read this Service Manual, and note and strictly 
    observe all Warning and Cautions as described in this document.
    Pay special attention to all of the safety information provided in the Safety Summary section. 
    For more information, see page 1-5.
    The following conventions are used in this document.
    WARNINGWarning statements describe conditions or actions that may result in a potentially 
    serious outcome, adverse event, or a safety hazard. Failure to follow a Warning may 
    result in death or serious injury to the user or to the patient. 
    CAUTIONCaution statements describe when special care is necessary for the safe and effective use of the 
    product. Failure to follow a caution may result in minor to moderate personal injury or damage to the 
    product or other property, a remote risk of more serious injury, or may cause environmental 
    pollution. 
    NOTENotes contain additional important information about a topic. 
    TIPA Tip contains suggested information on using a particular feature.
    Menu items and button names appear in bold no-serif font. Example: Touch the Config button.
    Internal software components or file directories appear in regular no-serif font. Example: 
    ECGs are stored to the 
    RubyArchiveInternal directory. 
    						
    							IntroductionSafety Summary
    PageWriter Trim Cardiograph Service Manual1-3
    Safety Summary
    Safety Symbols Marked on the Cardiograph 
    Symbol
    Name Description
     Attention See PageWriter Trim Instructions for Use for 
    information.
      Type CF ECG physio isolation is type CF, defibrillator proof. 
    Electrical leakage current is suitable for all patient 
    applications including direct cardiac application. 
      Alternating current Indicates that the cardiograph is receiving alternating 
    currents.
    On/Standby Pressing the button with this symbol on it turns on the 
    cardiograph or puts the cardiograph into Standby 
    (power saving mode).
    Electrostatic DischargeDo not touch exposed pins. Touching exposed pins can 
    cause electrostatic discharge that can damage the 
    cardiograph.
     Equipotential grounding post Equipotential grounding post used for establishing 
    common ground between instruments.
    Fuse Cardiograph contains a 1.5 amp (250V) time-delay 
    fuse.
    Input The connector near this symbol receives an incoming 
    signal.
    Serial Number The number next to this symbol is the serial number of 
    the cardiograph.
    Product model number The number next to this symbol is the product model 
    number of the cardiograph
    Entry of liquids The cardiograph is not protected against splashing 
    water.
    Entry of liquids The PIM (Patient Interface Module) is protected 
    against splashing water. Water splashed against the 
    PIM from any direction shall have no harmful effect.
    AC power indicator light When lit, indicates that AC power is on. The battery is 
    charging when inserted into the cardiograph.  
    						
    							IntroductionSafety Summary
    1-4PageWriter Trim Cardiograph Service Manual
    Global Medical Device 
    Nomenclature CodeGlobal Medical Device Nomenclature Code is a 5-digit 
    code providing a brief description of the device, as 
    defined by EN ISO 15225.
    Safety Symbols Marked on the Cardiograph (continued)
    Symbol
    Name Description
    Safety Symbols Marked on the Cardiograph Packaging 
    Symbol Description
     Keep dry.
    Ambient temperature range of 0 
    oC (32o.F) to 50 oC (122o F) (non-condensing) for 
    transport and storage.
    Atmospheric pressure range of 466 hPa to 1014 hPa for transport and storage.
    Relative humidity range of 15% to 90% (non-condensing) for transport and storage.
    Move and store packaging this end up.
     Fragile.
    Sealed lead acid battery. Do not dispose of in trash. Follow local regulations for disposing 
    of as small chemical waste. 
    						
    							IntroductionImportant Patient and Safety Information
    PageWriter Trim Cardiograph Service Manual1-5
    Important Patient and Safety Information
    The PageWriter Trim cardiograph isolates all connections to the patient from electrical ground 
    and all other conductive circuits in the cardiograph. This reduces the possibility of hazardous 
    currents passing from the cardiograph through the patient’s heart to ground, and from other 
    equipment connected to the patient passing through the leads into the cardiograph to ground. 
    WARNINGFailure to follow these warnings could affect both patient and operator safety.
    Symbol Description
    Dispose of in accordance with the requirements of your country. 
    This product consists of devices that may contain mercury, which must be recycled or 
    disposed of in accordance with local, state, or federal laws. (Within this system, the 
    backlight lamps in the monitor display contain mercury.)
    Safety Symbols Marked on the Cardiograph Packaging (continued)
    Safety and Regulatory Symbols Marked on the Cart
    Symbol Name Description
    Cart Transport Use care when moving the cardiograph cart. Pushing the cart 
    over bumps without holding onto the cardiograph may cause the 
    cart to tip.
    Cart Storage Bin 
    Weight LimitDo not place more than 3 kilograms or 6.6 pounds of weight 
    into the cart storage bin. 
    						
    							IntroductionImportant Patient and Safety Information
    1-6PageWriter Trim Cardiograph Service Manual
    WARNINGThe Welsh bulb electrodes (available as an accessory for the cardiograph) do not meet 
    the requirements of IEC 60601-2-25 for defibrillation recovery time, and cannot be 
    reliably used for immediate patient diagnosis following defibrillation.
    WARNINGThe PageWriter Trim I cardiograph is not recommended for diagnostic cardiograph use 
    during defibrillation. It does not provide real-time data in less than 10 seconds. Reusable 
    electrodes should not be used during defibrillation for diagnostic purposes as ECG 
    recovery will be greater than ten seconds.
    WARNINGDo not touch accessible connector pins and the patient simultaneously.
    Electrical shock hazard. Keep cardiograph, Patient Interface Module (PIM) and all 
    cardiograph accessories away from liquids. Do not immerse cardiograph, PIM, or other 
    accessories in any liquids.
    WARNINGWhen using additional peripheral equipment powered from an electrical source other 
    than the cardiograph, the combination is considered to be a medical system. It is the 
    responsibility of the operator to comply with IEC 60601-1-1 and test the medical system 
    according to the requirements. For additional information contact Philips Medical 
    Systems.
    WARNINGDo not use non-medical peripherals within 1.83 meters or 6 feet of a patient unless the 
    non-medical peripherals receive power from the cardiograph or from an isolation 
    transformer that meets medical safety standards.
    WARNINGAlways clean and disinfect reusable electrodes before patient use. Failure to properly 
    clean and disinfect reusable electrodes before patient use may cause infectious materials 
    to be transferred between patients. 
      CAUTIONThe Welsh bulb electrodes contain natural rubber latex which may cause allergic reactions.
    „When operating the cardiograph on AC power, ensure that the cardiograph and all other 
    electrical equipment connected to or near the patient are effectively grounded.
    „Use only grounded power cords (three-wire power cords with grounded plugs) and 
    grounded electrical outlets.
     Never adapt a grounded plug to fit an ungrounded outlet by 
    removing the ground prong. Use the equipotential post when redundant earth ground is 
    necessary according to IEC 60601-1-1.
    „If a safe ground connection is not ensured, operate the cardiograph on battery power only. 
    						
    							IntroductionImportant Patient and Safety Information
    PageWriter Trim Cardiograph Service Manual1-7
    „The use of equipment that applies high frequency voltages to the patient (including 
    electrosurgical equipment and some respiration transducers) is not supported and may 
    produce undesired results. Disconnect the patient data cable from the cardiograph, or detach 
    the leads from the patient prior to performing any procedure that uses high frequency 
    surgical equipment. 
    „Do not perform ST analysis on the R/T ECG screen display or on Rhythm reports when the 
    0.5 Hz Baseline Wander filter is applied. 
    „If abnormal ECG data appears on the printed report, and the abnormal data does not have a 
    physiological origin, perform the printer diagnostic test to assess printer performance.
    „When printing a Rhythm report, there may be a slight delay before the Rhythm report 
    begins to print on the cardiograph. Rhythm printing is not completed in real-time.
    „Pace pulse tick marks will not print on an Auto ECG that uses simultaneous acquisition.
    „Periodically inspect the patient data cable, lead wires, and AC power cord for any worn or 
    cracked insulation to ensure that no inner conductive material is exposed. Discard worn 
    accessories and replace them only with Philips Medical Systems accessories (see page 1-
    20).
    „Keep the patient data cable away from power cords and any other electrical equipment. 
    Failure to do so can result in AC power line frequency interference on the ECG trace.
    „The Philips Medical Systems patient data cable (supplied with cardiograph) is an integral 
    part of the cardiograph safety features. Use of any other patient data cable may compromise 
    defibrillation protection, degrade cardiograph performance, and may result in distorted 
    ECG data. 
    „Only qualified personnel may service the cardiograph or may open the cardiograph housing 
    to access internal cardiograph components. Do not open any covers on the cardiograph. 
    There are no internal cardiograph components that are serviced by the operator.
    „Do not use this cardiograph near flammable anesthetics. It is not intended for use in 
    explosive environments or in operating rooms.
    „Do not touch the patient, the patient data cable, any unused patient leads, or the cardiograph 
    during defibrillation. Death or injury may occur from the electrical shock delivered by the 
    defibrillator.
    „Always use electrode gel with reusable electrodes during defibrillation as ECG recovery 
    will be greater than 10 seconds. Philips Medical Systems recommends the use of disposable 
    electrodes at all times.
    „Ensure that the electrodes or lead wires do not come in contact with any other conductive 
    materials (including earth-grounded materials) especially when connecting or 
    disconnecting electrodes to or from a patient.
    „Connecting multiple medical electrical equipment to the same patient may pose a safety 
    hazard due to the summation of leakage currents. Any combination of instruments should 
    be evaluated by local safety personnel before being put into service. 
    						
    							IntroductionImportant Patient and Safety Information
    1-8PageWriter Trim Cardiograph Service Manual
    „Portable medical equipment such as X-rays and MRI may produce electromagnetic 
    interference that produces noise in the ECG signal. Move the cardiograph away from these 
    potential sources of electromagnetic interference.
    „Do not pull on the paper while an ECG report is being printed. This can cause distortion of 
    the waveform and can lead to potential misdiagnosis.
    „Only use the Philips Medical Systems AC power cord supplied with the cardiograph. 
    Periodically inspect the AC power cord and AC power connector (rear of cardiograph, see 
    page 1-15) to ensure that both are in a safe and operable condition. If the AC power cord or 
    AC power connector is not in a safe or operable condition, operate the cardiograph on 
    battery power and contact Philips Medical Systems for service.
    „The cardiograph has been safety tested with the recommended accessories, peripherals, and 
    leads, and no hazard was found when the cardiograph is operated with cardiac pacemakers 
    or other stimulators.
    „Do not connect any equipment or accessories to the cardiograph that are not manufactured 
    or approved by Philips Medical Systems or that are not IEC 60601-1 approved. The 
    operation or use of non-approved equipment or accessories with the cardiograph is not 
    tested or supported, and cardiograph operation and safety are not guaranteed.
    „The list of cables and other accessories with which Philips claims compliance with the 
    emissions and immunity requirements of IEC standard 60601-1-2 are listed in “Supplies 
    and Ordering Information” on page 1-20.
    „Only install Philips Medical Systems software on the cardiograph. The installation or use of 
    software not approved by Philips Medical Systems is strictly prohibited and cardiograph 
    safety and performance are not guaranteed. 
    „Only use Philips Medical Systems replacement parts and supplies with the cardiograph. The 
    use of non-approved replacement parts and supplies with the cardiograph is strictly 
    prohibited. Cardiograph safety and performance are not guaranteed when non-approved 
    replacement parts and supplies are used with the cardiograph.
    „Manual measurements of ECG intervals and magnitudes should be performed on printed 
    ECG reports only. Do not make manual measurements of ECG intervals and magnitudes on 
    the R/T ECG display since these ECG representations are scaled.
    „Only use patient electrodes that are approved by Philips Medical Systems. The use of non-
    approved patient electrodes may degrade cardiograph performance. 
    „The Philips Medical Systems warranty is applicable only if you use Philips Medical 
    Systems approved accessories and replacement parts. See “Supplies and Ordering 
    Information” on page 1-20 for more information.
    „Before using the Patient Cable Arm with the cardiograph cart, properly install the counter 
    weight on the cardiograph base.
    „Only use the shielded LAN cable provided with the PageWriter Trim cardiograph, Philips 
    part number 989803138021. Do not use any other LAN cables with the PageWriter Trim 
    cardiograph. Use of unapproved LAN cables may result in radiated emissions that exceed 
    the limit specified by CISPR11 Class B.  
    						
    							IntroductionThe PageWriter Trim Cardiograph
    PageWriter Trim Cardiograph Service Manual1-9
    „The combined maximum weight that can be placed on the cardiograph cart shelf and the top 
    surface of the cart cannot exceed 20 kg (44 lbs). Do not place more than the specified 
    weight on the cardiograph top surface and shelf. 
    „Do not connect any device to the RS-232 port on the rear of the cardiograph when the 
    patient data cable is connected to a patient.
    „There are no cardiograph parts that can be sterilized. 
    „The cardiograph is not intended for direct, or invasive cardiac monitoring purposes.
    „Excessive, repetitive use of the cardiograph keyboard and the cardiograph Trim Knob may 
    result in a risk of developing carpal tunnel syndrome.
    „Ensure that the patient data cable is tucked away from the cardiograph cart wheels when 
    transporting the cardiograph. Ensure that the patient data cable does not present a hazard 
    when pushing the cardiograph cart. 
    „For information on the standard IEC 60601-2-51, please see the document on the 
    PageWriter Trim Cardiograph User Documentation CD, or go to the Philips InCenter web 
    site (
    incenter.medical.philips.com). For information on using the Philips InCenter site, see 
    page 1-26.
    „The combined maximum weight that can be placed on the cardiograph cart shelf and the top 
    surface of the cart cannot exceed 20 kilograms (44 pounds). Do not place more than the 
    specified weight on the cardiograph top surface and shelf.
    „Ensure that the patient data cable is tucked away from the cardiograph cart wheels when 
    transporting the cardiograph. Ensure that the patient data cable does not present a hazard 
    when pushing the cardiograph cart.
    The PageWriter Trim Cardiograph
    Intended Use
    The intended use of the cardiograph is to acquire multi-channel ECG signals from adult and 
    pediatric patients from body surface ECG electrodes and to record, display, analyze, and store 
    these ECG signals for review by the user. The cardiograph is to be used in healthcare facilities 
    by trained healthcare professionals. Analysis of the ECG signals is accomplished with 
    algorithms that provide measurements, data presentations, graphical presentations, and 
    interpretations for review by the user.
    The interpreted ECG with measurements and interpretive statements is offered to the clinician 
    on an advisory basis only. It is to be used in conjunction with the clinicians knowledge of the 
    patient, the results of the physical examination, the ECG tracings, and other clinical findings. 
    A qualified physician is asked to overread and validate (or change) the computer-generated 
    ECG interpretation. 
    						
    							IntroductionThe Philips 12-Lead Algorithm
    1-10PageWriter Trim Cardiograph Service Manual
    Indications for Use
    The cardiograph is to be used where the clinician decides to evaluate the electrocardiogram of 
    adult and pediatric patients as part of decisions regarding possible diagnosis, potential 
    treatment, effectiveness of treatment, or to rule out causes for symptoms.
    The Philips 12-Lead Algorithm 
    The PageWriter Trim Cardiograph software uses the Philips 12-Lead Algorithm. The 
    algorithm in the software analyzes the morphology and rhythm on each of the 12 leads and 
    summarizes the results. The set of summarized measurements is then analyzed by the 
    clinically-proven ECG Analysis Program.
    12-lead Reports may include or exclude ECG measurements, reasons, or analysis statements.
    Intended Use
    The intended use of the Philips 12-Lead Algorithm is to analyze multi-channel ECG signals 
    from adult and pediatric patients with algorithms that provide measurements, data 
    presentations, graphical presentations, and interpretations for review by the user.
    The interpreted ECG with measurements and interpretive statements is offered to the clinician 
    on an advisory basis only. It is to be used in conjunction with the clinicians knowledge of the 
    patient, the results of the physical examination, the ECG tracings, and other clinical findings. 
    A qualified physician is asked to overread and validate (or change) the computer-generated 
    ECG interpretation.
    Indications for Use
    The Philips 12-Lead Algorithm is to be used where the clinician decides to evaluate the 
    electrocardiogram of adult and pediatric patients as part of decisions regarding possible 
    diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.
    Features and Capabilities
    The Philips PageWriter Trim family of cardiographs includes four product models: 
    PageWriter Trim Rx, PageWriter Trim III, PageWriter Trim II, and PageWriter Trim I. Each 
    cardiograph is designed to be economical, interpretive, and lightweight, and includes a remote 
    digital patient module. The cardiograph contains the controls, the printer, and all the 
    processing circuitry. 
    The features of the PageWriter Trim cardiographs include:
    „Battery or AC operated
    „Remote digital acquisition module with replaceable patient leads 
    „Capability for up to 12 leads 
    						
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