Surveyor Telemetry Central User Manual Rev A1

Copyright© 2006 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. SURVEYOR and X12+ are trademarks of Mortara Instrument, Inc.

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Manufacturer of Surveyor Central, Mortara Antenna Network, X12+ and PCI-RF Receiver Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414-354-4760 Internet: http://www.mortara.com

Technical Support and Service Headquarters

Sales Support/ Supplies & Accessories

Mortara Instrument, Inc.

Mortara Instrument, Inc.

7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414-354-4760 Internet: http://www.mortara.com

7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Fax : 414.354.4760 E-mail: [email protected]

European Economic Community Representative Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Oradour, 7 40016 San Giorgio di Piano, BO Tel: +39.051.6654311 Fax: +39.051.6651012

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Service: 888-MORTARA (888.667.8272) Fax : 414.354.4760 E-mail: [email protected]

Mortara Instrument GmbH (Germany) Kaninenberghohe 50 45136 Essen Tel: +49.201.268311 Fax: +49.201.268313

Mortara Instrument, B.V. (The Netherlands) H. Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Tel: +31.30.2205050 Fax: +31.30.2201531

24 Hour Technical Support Same Day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

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Notices Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance and safety of the device, only if article 2 of 93/42/CEE directive is applied, in particular: • • • • •

label guarantees the

System installation and assembly operations, extensions, readjustments, modifications or repairs are carried out only by persons authorized by Mortara Instrument, Inc. The device (Surveyor Telemetry Central) is used in accordance with the instructions for use. The system is correctly maintained according to the standards authorized by Mortara Instrument, Inc. using original spare parts. The system is used with original accessories and supplies that are in compliance with the standard specifications described in this manual. The electrical installation of the relevant room complies with the requirements of appropriate regulations.

Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. This manual must be kept in a safe place to prevent its deterioration and/or alteration. The user and Mortara Instrument, Inc. authorized personnel must have access to this manual at anytime. The user of this product must periodically check the X12+ transmitters, their functionality and the integrity of their accessories. Equipment Identification Mortara Instrument, Inc. equipment is identified by serial and part numbers on the side, back or bottom of the device. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument Inc. makes no commitment to update or to keep current the information contained in this document.

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Warranty Information Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment from Mortara. Normal use, service and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions: a)

Freight damage;

b) Parts and/or accessories of the Products not obtained from or approved by Mortara; c)

Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides;

d) Accident, a disaster affecting the Products; e)

Alterations or modifications to the Products not authorized by Mortara;

f)

Other events outside of Mortara Instrument’s reasonable control or not arising under normal operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Products (i) of all carrier charges with respect to any Products returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm or damage due directly or indirectly to an occurrence or consequence therefore relating to the Products. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm or damage, or the original purchase price of the Product when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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User Safety Information Means there is the possibility of personal injury to you or others. Warning Means there is the possibility of damage to the equipment. Caution Note

Provides information to further assist in the use of the device.

Federal law restricts this device for sale to and use by or on the order of a physician.

Safety Regulations The Surveyor Telemetry Central is a Medical Device labelled, according to European directive 93/42CEE (MDD), as a class 2b medical device. The telemetry model contains the radio receiver device “PCI-RF” produced by Mortara Instrument and marked

according to European directive 99/5 (RTTE). Various accessories, like

marked by the respective manufacturers according to the applicable European the monitor and printer are directives. See respective declarations of conformity for details. The Surveyor Telemetry Central cannot be classified as Medical Electrical Equipment according to the definition of safety standard IEC60601-1. The Surveyor Telemetry Central, together with all accessories that have a physical or logical connection with it, forms part of a Medical Electrical System. The Surveyor Telemetry Central complies with safety regulations as mentioned in Appendix E.

Warning •

The Surveyor Telemetry Central has not been designed to be used in the patient environment as defined in EN60601-1-1 (1.5 m from the patient’s bed and 2.5 m from the floor). The use of an isolation transformer between mains and Surveyor Telemetry Central is not a sufficient safety measure for use in the patient environment because of data connections (antenna network, data network) that might cause excessive leakage currents in some conditions.

•

The Surveyor Telemetry Central is not battery operated. For uninterrupted use, we recommend an appropriate uninterruptible power supply (UPS); note that, for uninterrupted use, also the antenna network (telemetry) as well as any active network components (connection with laser printer and monitors) need to be powered from the UPS. If power is interrupted for a short time (up to 2 hours) Surveyor Telemetry Central continues monitoring automatically and with the same settings when power returns. If power is interrupted longer, the Surveyor Telemetry Central returns to an empty window when power returns. All settings remain the same, as if monitoring is continued with the “Same Patient” command.

•

In order to be safely used, all accessories (like monitors, printers, data network etc) must be compatible, and comply with all safety and EMC regulations that apply to them according to their intended use; for use in Europe, these accessories should be CE-marked.

•

The Surveyor Telemetry Central, as all medical equipment or system, needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the installation procedure, in order to obtain a sufficient degree of immunity as well as not to create disturbance to other equipment. See installation instructions in chapter 2.

•

Cleaning must be performed with the device turned off. Let all parts dry well before turning the power back on.

•

The Surveyor Telemetry Central must be connected to a properly grounded power terminal, and the electrical installation must comply with the local safety requirements for the environment where it is used.

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•

Prevent liquids from penetrating inside the equipment and transmitter.

•

The various Manufacturers of accessories provide separate Operator Manuals (e.g. Monitor, Laser Printer, X12+, patient cables, electrodes). Read these manuals well; for specific functions please refer to these manuals. It is recommended to keep all manuals together.

•

Every hardware or software modification has to be made by authorized and trained technical personnel.

•

Technical and service documents are available if requested.

•

Always turn the system off before connecting or disconnecting cables.

•

Do not use the equipment in places with possible explosion hazard or in the presence of flammable gases.

•

Do not insert a bootable floppy disk or CD-ROM. Do not run any program from floppy disk or CD-ROM.

•

The Surveyor Telemetry Central main unit contains a small lithium battery for maintaining clock and BIOS settings, which should normally last the life of the device. If the battery needs to be replaced, be sure that it is done by qualified personnel and with a battery of the same type.

•

The Surveyor Telemetry Central software has been extensively tested and clinically validated and several protection mechanisms against software errors have been built into the Surveyor Telemetry Central. However, in the unlikely event of a failure of the software or the computer processor, the electronic (hardware) “watchdog” of the Surveyor Telemetry Central sounds a continuous loud beep, and the Central station has to be power-cycled to remove this. Please inform Mortara service personnel if this happens, for further troubleshooting.

•

Installation and connection to data and antenna networks must be performed by properly trained personnel, authorized by Mortara Instrument Inc.

The following warnings concern telemetry monitoring. •

Telemetry: QRS complexes with amplitude of less than 500 uV might not be recognized: change the electrode position in order to achieve a higher signal.

•

Telemetry: Electrostatic discharges may generate short interference on the ECG tracings.

•

Telemetry: High power magnetic fields with frequencies between 430 and 970 MHz may generate short interference on ECG tracings.

•

Telemetry: Transmitters with frequencies between 2400.96 and 2482.56 MHz may generate interference. In case of interference, please try with a different transmission channel (refer to the X12+ transmitter chapter that explains how to select transmission channels). Examples of these types of transmitters: leaking microwave ovens, radio therapy equipment, wireless LAN. Also transmitters in frequency ranges close to 2.4 GHz and with high output power can disturb telemetry reception.

•

Telemetry: The system has not been designed to be used with high frequency (HF) surgical devices.

•

Telemetry: Electrodes used with this system must apply to IEC 60601-2-25, article 51.102.

•

Telemetry: The use of the X12+ transmitter is restricted in some countries; see the X12+ user manual for details.

The following warnings concern pacemaker patients. •

Pacemaker patients: Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep pacemaker patients under close surveillance.

•

Pacemaker patients: Heart rate indication is usually not affected by pacemakers with direct cardiac application, ventricular, or supraventricular arrhythmias. However, in some conditions a pacemaker pulse can give rise to double QRS detections. Also, not activating the “Pacemaker present” field in the signals menu in the presence of a pacemaker may lead to beat detections without the presence of a QRS complex due to the detection of the pacemaker spike.

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•

Pacemaker patients: There is no other safety hazard if other equipment like pacemakers or other stimulators are used simultaneously with Surveyor Telemetry Central / X12+, but some devices may create disturbance of the signal.

The following warning concerns ventricular fibrillation. •

Heart rate indication is not reliable during episodes of ventricular fibrillation.

Warning

This manual applies to the most recently manufactured equipment, with respect to software release and hardware configuration. Whenever used for software upgrades on previously installed systems, some technical specifications or labels may not be respected, whereas functions and instructions for use of the equipment are always valid. The manual reflects software version 2.51.

Equipment Symbols Symbol Delineation Attention, consult accompanying documents

CE Mark

Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements

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Electromagnetic Compatibility (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using Surveyor Telemetry Central. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on Surveyor Central according to the international standard for EMC for medical devices (IEC 60601-1-2).This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2). Surveyor Telemetry Central should not be used adjacent to, or stacked on top of other equipment. If Surveyor Telemetry Central must be used adjacent to or stacked on top of other equipment, verify that Surveyor Telemetry Central operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See Table below for recommended separation distances between the radio equipment and Surveyor Telemetry Central. Accessories and Cables Warning: The use of accessories and cables other than those specified in this manual, may result in increased emissions or decreased immunity of the X12+ Transmitter. Please note the emissions and immunity declarations tables that follow.

Table X-1 Guidance and manufacturer’s declaration: Electromagnetic Emissions Surveyor Telemetry Central is intended for use in the electromagnetic environment specified below. The user of Surveyor Telemetry Central should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment / guidance

Group 1

Surveyor Central uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 RF emissions Class A CISPR 11 Harmonic emissions Not applicable IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3

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Not applicable

Surveyor Central is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Table X-2 Guidance and manufacturer’s declaration: Electromagnetic Immunity Immunity test

Test level

Compliance level

Electromagnetic environment / guidance

Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

±2 kV for power supply lines

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input/output lines

±1 kV for input/output lines

Surge

±1 kV line(s) to line(s)

±1 kV line(s) to line(s)

±2 kV lines(s) to earth

±2 kV lines(s) to earth

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

< 5% UT for 0.5 cycles 40 % UT for 5 cycles 70 % UT for 25 cycles < 5 % UT for 5s

< 5% UT for 0.5 cycles 40 % UT for 5 cycles 70 % UT for 25 cycles < 5 % UT for 5s

Note that monitoring is interrupted at the level “< 5 % UT for 5s”, but equipment remains safe (as specified in IEC 60601-1-2).

IEC 61000-4-2

IEC 61000-4-5

Power frequency (50/60 Hz) magnetic field

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-8 Voltage fluctuations and interruptions

NOTE UT is the a.c. mains voltage prior to application of the test level

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Table X-3 Guidance and manufacturer’s declaration: Electromagnetic Immunity The Surveyor Telemetry Central Station is intended for use in the electromagnetic environment specified below. The customer or the user of the H3+ should assure that it is used in such an environment. Immunity test

Test level

Compliance level

Electromagnetic environment / guidance Portable and mobile RF communications equipment should be used no closer to any part of Antenna Network, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V rms 150 KHz – 80 MHz

3 V/m 80 MHz to 2.28 GHz

3 V rms 150 KHz – 80 MHz

3 V/m 80 MHz to 2.28 GHz

d = 1.2 d = 1.2

80 MHz to 800 MHz

d = 2.3

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Interference may occur in the vicinity of equipment that transmits in the frequency band that is used in Surveyor Central for its intended function (2.4 – 2.8 GHz) a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur 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, an electromagnetic site survey should be considered. If the measured field strength in the location in which Surveyor Central is used exceeds the applicable RF compliance level above, Surveyor Central should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Surveyor Central active components. b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table X-4 Recommended separation distances between portable and mobile RF communications equipment and Surveyor Telemetry Central active components Surveyor Telemetry Central is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of Surveyor Central can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Surveyor Telemetry Central as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz ÷ 80 MHz 80 MHz ÷ 800 MHz 800 MHz ÷ 2.5 GHz d = 1.2

d = 1.2

d = 2.3

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 3 For RF-transmitters that radiate around the working band of the telemetry transmitters (2.280 – 2.607 GHz) interference can occur also at shorter distances.

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Table of Contents 1 Introduction Surveyor Telemetry Central Overview...1-1 Manual Purpose ...1-1 Audience ...1-1 Indications for Use ...1-1 System Description ...1-2 The Surveyor Telemetry Central System Includes ...1-2 The Surveyor Telemetry Central X12+ Transmitter...1-3 The Surveyor Telemetry Central and the Antenna Network...1-3 Routine maintenance and cleaning instructions ...1-4 Disposal of waste materials ...1-4 Privacy Information ...1-5 Installation and connections...1-6 Main Unit connection ...1-6 Antenna network connections ...1-7

2 Using the System Turning on the Surveyor Telemetry Central ...2-1 Display Screen ...2-1 Multi-patient display sub-screen fields ...2-2 Moving the cursor ...2-2 Single Patient Display ...2-3 Single Patient Display Tabs ...2-3 Beginning a monitoring session ...2-4 Reduced lead set monitoring ...2-5 Ending a telemetry monitoring session...2-6

3

Setting

Printing ...3-2 12 Lead ...3-2 Report...3-2 Rhythm ...3-2 Change display gain ...3-2 Change the lead(s) to be displayed ...3-2 Changing the parameters to be displayed ...3-2

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4 Alarm Settings Alarms ... 4-1 Alarm hierarchy ... 4-1 Display Alarms... 4-2 How to silence alarms ... 4-2 Permanent (latched) and Non-Permanent (non-latched) alarms ... 4-2 Alarm Printout ... 4-2 Overlapping alarms ... 4-3 Alarms Messages ... 4-3 Changing alarm limits ... 4-4 ST alarms ... 4-4 Heart Rate Alarms ... 4-4 Ventricular Tachycardia Alarm ... 4-4 ECG morphology ... 4-5 Cardiac Arrest Limit ... 4-5 Alarm suspended... 4-5 Relearn ... 4-5 Rhythm relearn ... 4-5 Disabling alarms ... 4-6 QRS detection and type recognition... 4-6

5

Average Complexes

Compare ... 5-2 Measurement points ... 5-2

6 Trends Single Trend view ... 6-1 Multi Trend view... 6-2

7

Review

Navigation... 7-1 Options ... 7-2 Alarm Filter... 7-2 Rhythm ... 7-3

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8 12 Lead 12-lead ECG ...8-1

9

System Configuration

User preference group ...9-1 ST delay ...9-1 Filter 35 Hz ...9-1 Detection lead 1 ...9-1 Detection lead 2 ...9-1 Confirmation lead ...9-1 Minimum QRS amp...9-1 Alarm configuration ...9-1 Volume ...9-2 Day Alarms and Warnings ...9-2 Night Alarms and Warnings ...9-2 Alarm Volume...9-2 Warning Volume...9-2 Start Day ...9-2 Start Night ...9-2 Permanent alarm...9-2 User configuration...9-2 Language ...9-3 Date format ...9-3 Hospital ...9-3 Default alarm profile...9-3 1-lead ST-change...9-3 2-lead ST-change...9-3 Low Heart Rate ...9-3 High Heart Rate ...9-3 Run length ...9-3 Run rate (bpm) ...9-3 Arrest limit ...9-3 Morphology ...9-3 Automatic print ...9-3 Window setup and identification ...9-4 Name...9-4 Type ...9-4 Telemetry channel...9-4 Printers management...9-5 Change date and time...9-5

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10 Troubleshooting for the Clinician Troubleshooting Chart ... 10-1

Appendix A Network for Surveyor Manual Description and Use ...A-1 Manual Purpose...A-1 Network for Surveyor Includes: ...A-1 Safety Regulations ...A-1 Warnings...A-1 Maintenance and cleaning...A-2 Network Use ...A-3 Troubleshooting ...A-4 Technical Specifications ...A-4

Appendix B Alarm details Alarm details table ...B-1

Appendix C Printout examples Printout example in ECG Mode ... C-1 Printout example in ECG Report Mode ... C-2 Printout example in ECG Rhythm... C-3

Appendix D Equipment Symbols Equipment symbols table ... D-1

Appendix E Technical Specifications Surveyor Telemetry Central Specifications ...E-1

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Appendix F Mortara Antenna Network Functional description ... F-1 Symbols ... F-2 Connections and installations ... F-3 Safety Regulations... F-4 Maintenance and cleaning ... F-5 Special requirements and notices concerning Electromagnetic Compatibility ... F-6 Technical specification... F-7

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__________________________________________________________________________________ Section 1

1 Introduction Surveyor Telemetry Central Overview Manual Purpose The User Manual explains how to operate the Surveyor Telemetry Central System and available options. The manual explains how to • • • •

Set up the Surveyor Telemetry Central System Use and understand the Surveyor Telemetry Central System Enter, modify and delete information Perform common operator tasks

Audience This manual is written for clinical professionals who are expected to have a working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

Indications for Use The Surveyor Telemetry Central Station System is indicated for use: •

In a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements

•

For centralized ECG monitoring through a telemetry network of adult patients in Coronary Care Units, StepDown Units, and Emergency Departments. It is not designed for use in highly invasive environments, such as an operating room.

•

Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.

•

ST Segment Analysis with an alarm according to the alarm profile. Note

The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician.

•

Evaluation of adult patients with pacemakers

•

Reporting of time domain heart rate variability

•

Evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

•

Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients

•

Clinical and epidemiological research studies

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Surveyor Telemetry Central____________________________________________________________________

System Description The intended function of Surveyor Telemetry Central, which is designed to work exclusively in conjunction with Mortara X12+ transmitters with wireless communication to Surveyor antenna network, are: •

Real-time 5-Lead and 12-lead, diagnostic bandwidth ECG signal display coming from up to 24 patients connected to X12+ telemetry transmitters (with type “PCI” hardware).

•

Automatic monitoring of arrhythmias and ST changes, including one displayed waveform for each patient.

•

Visual and audible alarms of arrhythmias and set parameters with adjustable priorities

•

Averaged and reference QRS complexes

•

Graphical Trends

•

3, 6 or 12 lead ECG printing and report printing for all monitored patients.

•

ECG signal data storage with trends for the latest 30 hours.

Patients can be monitored through telemetry, when moving in a defined area, of a variable size depending on layout and thickness of walls. In order to guarantee a proper signal transmission in each different situation, an antenna network can be installed according to customer needs. The Surveyor Telemetry Central can also be connected using an existing network (if available). Whenever the Surveyor Telemetry Central IP addresses may be in conflict with other devices on the same network, please contact Mortara Instrument Inc. Technical Support. For safety reasons, any link between the Surveyor network and a customer's private network must be approved by Mortara Instrument Inc.

The Surveyor Telemetry Central System includes: •

Main Unit CPU Two software configurations available: o

Up to 16 telemetry channels

o

20 or 24 telemetry channels

Six system configurations available: o

4 telemetry receivers

o

8 telemetry receivers

o

12 telemetry receivers

o

16 telemetry receivers

o

20 telemetry receivers

o

24 telemetry receivers

•

Color monitor

•

Trackball and keyboard

•

Network LaserJet printer

The system uses an HP 4250 LaserJet printer with network option. The laser printer must be plugged into the AC power outlet through the appropriate power cord, or other EN normative compliant power cord.

Please refer to the LaserJet printer manufacturer’s user manual for information, warnings, commands and intended use.

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