User Manual Part 4

ManualsBrandsGE Medical Systems Information Technologies ManualsElectronicsMedical Telemetry Transmitter

viii ApexPro™ 2001989-301A- draft 1

E Technical specifications . . . . . . . . . . . . . . . . . . . . . . E-1

ApexPro and ApexPro CH transmitters. . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2

Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2

Alarms and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2

Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2

Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

ApexPro telemetry server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Display specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

ApexPro receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

Performance specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

Network requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

Draft

Summary of content (13 pages)

PAGE 1
E Technical specifications . . . . . . . . . . . . . . . . . . . . . . E-1 ApexPro and ApexPro CH transmitters. . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Alarms and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 ECG . . . . . . .
PAGE 2
Introduction Dr af t 1 2001989-301A- draft 1 ApexPro™ 1-1
PAGE 3
Introduction Manual information Purpose This manual contains the instructions necessary to operate the ApexPro telemetry system safely and in accordance with its function and intended use. It also contains limited instructions necessary to operate the telemetry system when used with the CIC Pro Clinical Information Center. For more information, refer to Related documents on page 1-2. Intended audience This manual is intended for clinical professionals.
PAGE 4
Introduction Term Description Transmitter Refers to the CARESCAPE Telemetry T14 transmitter. Writer Refers to the PRN 50-M digital writer. Text styles This manual uses the following text styles to identify hardware terms, software terms and the correct way to enter data. Style Indicates hardware items, such as keys, labels or connectors. Bold and italicized Indicates software items, such as menus, menu options or screen text. Italics Emphasizes a word.
PAGE 5
Introduction Equipment information Intended use of this equipment 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 patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
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Introduction WARNING 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 essential performance standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard.
PAGE 7
Introduction WARNING ALARMS — Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of Alarm Volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. After connecting the monitor to the central station, nurse-call system, and/or network, verify the function of the alarm system.
PAGE 8
Introduction WARNING CONDUCTIVE CONNECTIONS — Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device.
PAGE 9
Introduction WARNING ELECTROMAGNETIC INTERFERENCE — Operation of transmitters outside the designated WMTS frequency band is at increased risk for electromagnetic interference. WMTS is protected in the U.S. only. This interference could lead to lapses in patient monitoring and missed alarm events, putting the patient at risk and compromising patient safety. WARNING EMC— Magnetic and electrical fields are capable of interfering with the proper performance of the device.
PAGE 10
Introduction WARNING IMPROPER TRANSMITTER/LEADWIRE APPLICATION — Applying a transmitter and/or leadwire that is not thoroughly dry to a patient can result in an electrically conductive path being established and a Leads Fail alarm not being provided if leadwires come off the patient.
PAGE 11
Introduction WARNING LOSS OF DATA —Caregivers and telemetry patients should be made aware of antenna coverage areas. Movement outside of the coverage area may result in loss of patient monitoring. WARNING NETWORK INTEGRITY — The ApexPro server resides on the Unity network. It is possible that inadvertent or malicious network activity could adversely affect patient monitoring. The integrity of the Unity network is the responsibility of the hospital.
PAGE 12
Introduction 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. WARNING SINGLE PATIENT USE —This transmitter is designed for use on one patient at a time. Using this equipment to monitor different parameters on different patients at the same time compromises the accuracy of data acquired.
PAGE 13
Introduction CAUTION DISPOSAL — At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of the product, please contact GE or its representatives. CAUTION ELECTROCAUTERY PRECAUTIONS — To prevent unwanted skin burns, apply electrocautery electrodes as far as possible from all other electrodes, a distance of at least 15 cm/6 in.