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ApexPro Telemetry System
ApexPro Antenna Infrastructure, Transmitter and Receiver Technical Manual Oct 2008
Technical Manual
192 Pages
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GE Healthcare
ApexPro™ Antenna Infrastructure, Transmitter, and Receiver Technical Manual
ApexPro™ English 2028341-019 (cd) 2028340-042A (paper) © 2008 General Electric Company. All rights reserved.
NOTE Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE The information in this manual only applies to ApexPro software version 3A and later, ApexPro CH software version 1A and later, and the ApexPro, ApexPro CH, and CARESCAPE telemetry T14 transmitters hardware. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies. Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained herein are the property of their respective owners. APEX, ApexPro, CARESCAPE and DINAMAP Pro are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. CIC is a trademark of GE Medical Systems Information Technologies.
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Contents 1
Introduction... 1-1 Manual Information... 1-2 Revision history... 1-2 Purpose... 1-2 Intended audience... 1-2 Ordering manuals... 1-2 Conventions... 1-2 Safety information... 1-3 Intended use... 1-3 Responsibility of the manufacturer... 1-3 Equipment symbols... 1-3 Safety statements... 1-5 Service information... 1-8 Service requirements... 1-8 Equipment identification... 1-9
2
Equipment Overview... 2-1 System overview... 2-2 Overview... 2-2 Power requirements... 2-3 Interface with ApexPro receiver subsystem... 2-3 Interface with multiple ApexPro receiver subsystems... 2-3 Equipment... 2-3 Unity Network... 2-3 ApexPro antenna system... 2-4 Enterprise Access antenna system... 2-6 ApexPro and CARESCAPE transmitters... 2-6 Transmitter controls, indicators and labels... 2-9 Transmitter interfaces... 2-12 DINAMAP PRO series monitors... 2-14 SpO2 oximeter modules... 2-14 Apex oximeter... 2-15 Interconnection cables... 2-16 ApexPro receiver system... 2-17
3
Installation and configuration... 3-1 Infrastructure installation... 3-2 Overview... 3-2 Install coaxial cable... 3-2 Install antennas... 3-9
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Install antenna amplifiers... 3-9 Install attenuators... 3-11 Install power supplies and bias tees... 3-11 Install notch/bandpass filters... 3-12 ApexPro receiver installation... 3-13 Mounting options... 3-13 Connections... 3-14 Setup antenna fields... 3-15 Setup the receiver... 3-17 Transmitter installation... 3-17 Programming the transmitter for use... 3-18 Transmitter configuration... 3-18 Program code storage... 3-18 Error log... 3-18 Parameters... 3-18 Manually view/program TTX... 3-19
4
Maintenance... 4-1 ApexPro CH Telemetry Tune-Up... 4-2 Introduction... 4-2 Visual inspection... 4-4 Inspect for damage... 4-4 Verify transmitter features... 4-4 Verify labels... 4-5 Cleaning... 4-5 Cleaning products to avoid... 4-6 Transmitter/device cleaning... 4-6 ECG cable/leadwire cleaning... 4-8 Calibration... 4-10 Transmitter calibration... 4-10 Receiver calibration... 4-15
5
Troubleshooting... 5-1 Troubleshooting tree 1... 5-2 Troubleshooting tree 2... 5-3 ApexPro transmitter troubleshooting tree... 5-4 System troubleshooting... 5-5 RF drop-out determination... 5-5 Yellow drop-out condition... 5-5 Quick antenna system checks... 5-7
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Antenna system troubleshooting... 5-7 ApexPro transmitter carrier impairment measurement procedure... 5-9 Rationale for test... 5-9 Equipment needed... 5-10 Rohde & Schwarz FSH3 test procedure... 5-10 Receiver subsystem troubleshooting... 5-13 Receiver Subsystem LED status chart... 5-13 General fault isolation... 5-14 Verify connectivity... 5-15 AC line voltage test... 5-18 Event logs... 5-19 Before calling service... 5-21 System dropout... 5-21 Transmitter... 5-21 Apex oximeter and Nonin Xpod oximeter... 5-23 Apex oximeter short battery life... 5-23 Power shutdown during leads fail... 5-24 ApexPro... 5-24 ApexPro CH and T14... 5-24
6
Replaceable parts... 6-1 Mounting hardware and labels... 6-2 Optional antenna mounting kits... 6-3 Power supply... 6-4 Bias tee... 6-4 Bias tee & power supply mounting kit... 6-5 Antenna amplifier... 6-5 Coaxial cabling - RG-6 and RG-11... 6-6 Connectors... 6-6 Adapters... 6-8 Block and terminator... 6-9 75-Ohm terminator... 6-9 DC-power block... 6-9 Splitters/combiners... 6-9 DC passing attenuators... 6-10 Notch filters... 6-10
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Bandpass filters... 6-14 ApexPro bandpass filter 608-614 MHz... 6-14 Cavity bandpass filter 608-614 MHz... 6-16 International bandpass filter 433.05-434.75 MHz... 6-18 International bandpass filter 458.5-459.1 MHz... 6-19 Power cords... 6-19 Ordering parts... 6-20 Ordering parts... 6-20 Field replaceable units... 6-20 Label kits... 6-21 Transmitters... 6-22 Interconnect cables... 6-22 Labels... 6-22 ApexPro... 6-22 ApexPro CH... 6-23 T14... 6-23 Optional components and accessories... 6-23 ApexPro CH transmitter parts list... 6-23 T14 transmitter parts list... 6-24 Receiver subsystem disassembly guidelines... 6-24 General... 6-24 Replace the fuse... 6-25 Open the unit... 6-25 Remove a quad receiver module... 6-26 Add a quad receiver module... 6-26 Remove/replace the power supply assembly... 6-27 Remove/replace receiver subsystem pcb (backplane)... 6-27 Close and reconnect unit... 6-28 Receiver system drawings... 6-29 Receiver assembly... 6-29 Quad receiver module... 6-30
7
Checkout... 7-1 Antenna checkout... 7-2 Procedure... 7-2 Infrastructure equipment checkout... 7-2 Procedure... 7-2 Receiver subsystem checkout... 7-2 Checkout procedure... 7-2
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Additional system tests... 7-3 Transmitter checkout... 7-11 Checkout procedure... 7-11 Additional system tests... 7-12 Oximeter operational tests... 7-19 Apex oximeter... 7-19 Nonin Xpod... 7-20 Accutracker DX NIBP operational tests... 7-20 Display... 7-21 Pressure calibration check... 7-21 Over-pressure release check... 7-22 Hardware time-out and system leak check... 7-22 Communication test... 7-23 Repair log... 7-23
A
Technical specifications... A-1 ApexPro and ApexPro CH transmitter... A-2 Performance specifications... A-2 Environmental specifications... A-3 Device specifications... A-3 Analog/digital... A-4 Physical specifications... A-4 Certifications... A-5 T14 transmitter... A-5 Performance specifications... A-5 Environmental specifications... A-6 Device specifications... A-6 Physical specifications... A-7 FCC compliance information... A-7 Certifications... A-7 Apex oximeter... A-8 Performance specifications... A-8 Physical specifications... A-8 Certification... A-8 Nonin Xpod oximeter... A-9 Performance specifications... A-9 Physical specifications... A-9 Certification... A-9 Accutracker DX noninvasive blood pressure monitor... A-9 Performance specifications... A-9 Environmental specifications... A-11 Physical specifications... A-11 Certification... A-11
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ApexPro receiver... A-12 Performance specifications... A-12 Environmental specifications... A-12 Physical specifications... A-13 Certification... A-13 Antenna specifications... A-13 Performance specifications... A-13 Environmental specifications... A-14 Physical specifications... A-14 Warranty information... A-14 Power supply specifications... A-14 Power requirements... A-14 Environmental specifications... A-14 Device specifications... A-15 Bias tee specifications... A-15 Environmental specifications... A-15 Device specifications... A-15 Bias tee & power supply mounting kit specifications... A-16 Physical specifications... A-16 Antenna amplifier specifications... A-16 Environmental specifications... A-16 Device specifications... A-16
B
Electromagnetic compatibility... B-1 ApexPro and CARESCAPE transmitters... B-2 Electromagnetic compatibility (EMC)... B-2 Guidance and manufacturer’s declaration – electromagnetic emissions . B-2 Guidance and manufacturer’s declaration – electromagnetic immunity . . B-3 Recommended separation distances... B-5 Compliant cables and accessories... B-6 ApexPro receiver... B-7 Electromagnetic compatibility (EMC)... B-7 Guidance and manufacturer’s declaration... B-7 Recommended separation distances... B-10 Compliant cables and accessories... B-11
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Introduction
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Introduction
Manual Information Revision history Each page of this manual has the document part number and revision letter at the bottom of the page. The revision letter identifies the document’s update level. The revision history of this document is summarized below. Revision A
Comment Initial release
Purpose This manual provides technical information for maintaining the ApexPro, ApexPro CH and CARESCAPE T14 transmitters, ApexPro receiver subsystem, ApexPro antenna infrastructure equipment and GE equipment that connects to the transmitter.
Intended audience Users of this manual are expected to have a background in electronics, including analog and digital circuitry, RF, and microprocessor architectures. It is intended for service representatives and technical personnel who maintain, troubleshoot or repair this equipment.
Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.
Conventions Style
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Definition
bold
Indicates hardware items such as keys, labels, or text entered by the user.
bold italic
Indicates software terms such as menu items or screen text.
+
Indicates keyboard keys to select simultaneously.
>
Indicates menu options to select consecutively.
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Introduction
Safety information Intended use The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating adult and pediatric patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, non-invasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.
Responsibility of the manufacturer GE is responsible for the effects of safety, reliability, and performance only if:
assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;
the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and
the device is used in accordance with the instructions for use.
Equipment symbols NOTE Some symbols may not appear on all equipment.
ATTENTION: Consult accompanying documents.
Non-ionizing electromagnetic radiation: To indicate elevated, potentially dangerous, levels of non-ionizing radiation. Note In case of application in a warning sign the rules according to ISO 3864-1 shall be adhered to. IEC 60878 note: See safety sign ISO 7010 - W005 “Warning, non-ionizing radiation”.
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Type CF applied part: Isolated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application. “Paddles” outside the box indicate the applied part is defibrillator proof. [Medical Standard Definition:] F-type applied part (floating/isolated) complying with the specified requirements of IEC 60601-1/UL 60601-1/CSA 601.1 Medical Standards to provide a higher degree of protection against electric shock than that provided by type BF applied parts. NOTE The rating of protection against electric shock (indicated by symbol for CF) is achieved only when used with patient applied parts recommended by GE. TYPE B APPLIED PART: Non-isolated applied part suitable for intentional external and internal application to the patient excluding direct cardiac application. [Medical Standard Definition:] Applied part complying with the specified requirements of IEC 60601-1/UL 60601-1/CSA 601.1 Medical Standards to provide protection against electric shock, particularly regarding allowable leakage current.
R&TTE equipment class 2 identifier: An alert sign, indicating that transmitting radio equipment operates in nonharmonized frequency bands and can cause interference.
Equipotential
DC In/RF Out or DC Out/RF In
DC In or RF In
For indoor use only.
Power supply cable configuration. + = Power – = Return Medical Equipment With respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, and CAN/CSA C22.2 NO. 601.1 and if applicable, IEC 60601-2-27, IEC 60601-2-30, and IEC 60601-2-49. 4P41
CE mark CE-0459 indicating conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices, and fulfills the essential requirements of Annex I of this directive.
INTFC.
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Interface Connector(s)
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Introduction
Complies with IPX3 standards for water ingress
Complies with IPX7 standards for water ingress
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
This symbol indicates the date of manufacture of this device. The first 4 digits identify the year and the last 2 digits identify the month.
2005-08 Manufacturer name and address.
European authorized representative.
Safety statements Dangers Danger statements identify an imminent hazard which, if not avoided, will result in death or serious injury. No danger statements apply to this product.
Warnings Warning statements identify a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. The following warnings apply to this product. WARNING BEFORE USE -Periodically, and whenever the integrity of the device is in doubt, test all functions.
WARNING EXPLOSION HAZARD -Do not use this equipment in the presence of flammable anesthetics, vapors or liquids.
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Introduction
WARNING FALSE CALLS-False low heart rate indicators or false asystole calls may result with certain pacemakers because of electrical overshoot.
WARNING INTERFACING WITH OTHER EQUIPMENT -Contact GE for information before connecting any devices to the equipment that are not recommended in this manual.
WARNING LOSS OF DATA - Notify the affected users relying upon this data flow before shutting down the ApexPro™ antenna infrastructure components for any reason.
WARNING MONITORING PACEMAKER PATIENTS -Monitoring of pacemaker patients can only occur with the pace program activated.
WARNING PACEMAKER SPIKE -An artificial pacemaker spike is displayed in place of the actual pacemaker spike. All pacemaker spikes appear uniform. Do not diagnostically interpret pacemaker spike size and shape.
WARNING PATIENT HAZARD -A pacemaker pulse can be counted as a QRS during asystole in either pace mode. Keep pacemaker patients under close observation.
WARNING RATE METERS-Keep pacemaker patients under close observation. Rate meters may continue to count the pacemaker rate during cardiac arrest and some arrhythmias. Therefore, do not rely entirely on rate meter alarms.
Cautions Caution statements identify a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage. The following cautions apply to this product.
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CAUTION ACCESSORIES (SUPPLIES) -To ensure patient safety, use only parts and accessories manufactured or recommended by GE. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601 medical electrical systems standard.
CAUTION ACCESSORIES (EQUIPMENT) -The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
use of the accessory in the patient environment; and
evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601 harmonized national standard.
CAUTION FDA POSTMARKET SAFETY ALERT-The United States FDA Center for Devices and Radiological Health issued a safety bulletin October 14, 1998. This bulletin states “that minute ventilation rateadaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic equipment, causing the pacemakers to pace at their maximum programmed rate.” The FDA further recommends precautions to take into consideration for patients with these types of pacemakers. These precautions include disabling the rate responsive mode and enabling an alternate pace mode. For more information contact: Office of Surveillance and Biometrics, CDRH, FDA 1350 Piccard Drive, Mail Stop HFZ-510 Rockville, MD 20850 U.S.A.
CAUTION POWER REQUIREMENTS -If the installation of the equipment, in the USA, uses 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.
CAUTION RESTRICTED SALE -Federal law restricts this device to be sold by or on the order of a physician.
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Introduction
CAUTION SUPERVISED USE -This system is intended for use under the direct supervision of a licensed health care practitioner.
Notes Note statements provide application tips or other useful information to assure that you get the most from your equipment. The following notes apply to this product. NOTE ECG monitoring with patients on non-invasive transcutaneous pacemakers may not be possible due to large amounts of energy produced by these devices. Monitoring ECG with an external device may be needed. NOTE This device is not intended for home use. NOTE Patient environment is any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system. (IEC 60601-1-1)
Service information Service requirements Follow the service requirements listed below.
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Refer equipment servicing to GE authorized service personnel only.
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 or to one of their authorized agents.
Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.
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Introduction
Equipment identification Every GE device has a unique serial number for identification. A sample of the information found on a serial number label is shown below.
### ## ## #### # #
A
B
C
D
E
F
Description A
product code1
B
year manufactured
C
fiscal week manufactured
D
production sequence number
E
manufacturing site
F
miscellaneous characteristic 1The product code is: TT for ApexPro transmitter, domestic; AM for
ApexPro transmitter, international; T9 for ApexPro CH transmitter; SE3 for the CARESCAPE Telemetry T14 transmitter; RTS for US (560-614 MHz) ApexPro receiver subsystem; and RAV for international (420-474 MHz) ApexPro receiver subsystem.
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Equipment Overview
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