Philips Trim 1 Service Manual
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1 1-1 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