Surveyor Central User Manual V5.1 Rev G July 2019

© 2019 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn, Inc. Welch Allyn is a registered trademark of Welch Allyn, Inc. E-Scribe, HScribe, Surveyor, and VERITAS are trademarks of Welch Allyn, Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation. Software V5.1, 2017-07 For patent information, please visit www.welchallyn.com/patents For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html 1.888.667.8272, [email protected]

9515-169-90-ENG Rev G Revision date: 2019-07 901137 MONITORING CENTRAL STATION

EU IMPORTER

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallyn.com

Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland

1. NOTICES Manufacturer’s Responsibility Welch Allyn, Inc. is responsible for the effects on safety and performance of the device, as indicated by the label, only if article 2 of 93/42/EEC directive is applied, in particular:  System installation and assembly operations, extensions, readjustments, modifications or repairs are carried out by personnel authorized by Welch Allyn, Inc. only. 

The device is used in accordance with the instructions for use.



The device is correctly maintained according to the standards authorized by Welch Allyn, Inc. using original spare parts.



The device is used with compatible accessories and supplies. Contact Welch Allyn or one of its affiliates for a current list of compatible accessories and supplies.



The electrical installation of the relevant room complies with the requirements of appropriate regulations.

Responsibility of the Customer The user of this device 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 Welch Allyn, Inc. authorized personnel must have access to this manual at any time. The user of this device must periodically check the transmitters and monitors, their functionality and the integrity of their accessories.

Equipment Identification Welch Allyn, 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 into another language without prior written consent of Welch Allyn, Inc.

Other Important Information The information in this document is subject to change without notice. Welch Allyn, 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. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Welch Allyn, Inc. makes no commitment to update or to keep current the information contained in this document.

Notice to EU Users and/or Patients: Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Disposal This product and its accessories must be disposed of according to local laws and regulations. Do not dispose of this product as unsorted municipal waste. For more specific disposal information see www.welchallyn.com/weee.

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2. WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Welch Allyn, or if not otherwise noted, for a period of twelve (12) months from the date of shipment. Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions: a) Freight damage; b) Parts and/or accessories of the Product/s not obtained from or approved by Welch Allyn; c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides; d) Accident; a disaster affecting the Product/s; e) Alterations and/or modifications to the Product/s not authorized by Welch Allyn; f) Other events outside of Welch Allyn’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 PRODUCT/S FOUND UPON EXAMINATION BY WELCH ALLYN TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Welch Allyn of any alleged defects promptly after discovery thereof within the warranty period. Welch Allyn’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Welch Allyn’s principal place or any other place as specifically designated by Welch Allyn or an authorized distributor or representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Welch Allyn is limited and that Welch Allyn does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Welch Allyn is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL WELCH ALLYN 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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TABLE OF CONTENTS 1.

NOTICES ... 1 MANUFACTURER’S RESPONSIBILITY ... 1 RESPONSIBILITY OF THE CUSTOMER ... 1 EQUIPMENT IDENTIFICATION... 1 COPYRIGHT AND TRADEMARK NOTICES ... 1 OTHER IMPORTANT INFORMATION... 1 NOTICE TO EU USERS AND/OR PATIENTS: ... 1 DISPOSAL ... 1

2.

WARRANTY INFORMATION ... 2 YOUR WELCH ALLYN WARRANTY... 2

3.

SAFETY INFORMATION ... 7 SAFETY REGULATIONS... 7 WARNINGS... 7 NOTES ... 14

4.

EQUIPMENT SYMBOLS AND MARKINGS ... 15 PRODUCT LIFETIME ... 15

5.

ELECTROMAGNETIC COMPATIBILITY... 16

6.

INTRODUCTION ... 20 PURPOSE ... 20 AUDIENCE ... 20 INTENDED USE ... 20 INDICATIONS FOR USE ... 20 SYSTEM DESCRIPTION ... 21 OPTIONAL SYSTEM COMPONENTS... 23 SYSTEM SOFTWARE OPTIONS ... 24 SURVEYOR CENTRAL NETWORK ... 25 SURVEYOR CENTRAL CONNECTIONS... 27 INSTALLATION AND CONNECTIONS ... 28 ROUTINE MAINTENANCE AND CLEANING INSTRUCTIONS ... 28 DISPOSAL OF WASTE MATERIALS ... 28 PRIVACY INFORMATION ... 29

7.

USING THE SYSTEM ... 30 TURNING ON THE SURVEYOR CENTRAL WORKSTATION ... 30 MULTI-PATIENT DISPLAY BUTTONS ... 31 MULTI-PATIENT DISPLAY SUB-SCREEN FIELDS ... 32 SINGLE-PATIENT DISPLAY ... 34 EVENT/ALARM AND FULL-DISCLOSURE REVIEW ... 36 BEGINNING A 12-LEAD ECG MONITORING SESSION ... 37 ENDING A MONITORING SESSION: TELEMETRY ... 43 RESTARTING A MONITORING SESSION: TELEMETRY ... 43

8.

SETTINGS ... 44 DISPLAY SETTINGS ... 45 PRINT SETTINGS... 46 SIGNAL SETTINGS ... 50

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TABLE OF CONTENTS

SAVE AS PROFILE ... 51 9.

ALARM SETTINGS ... 52 PATIENT MONITOR-SPECIFIC ALARM INTERACTIONS ... 52 ALARMS AND EVENTS ... 53 PERMANENT AND NON-PERMANENT ALARMS... 54 OVERLAPPING ALARMS ... 54 ALARM AND EVENT MESSAGES ... 54 SUSPENDED ALARMS ... 54 ALARM RE-ACTIVATION ... 55 DISABLING ALARMS ... 55 SETTING ALARM EVENT AUTOMATIC PRINTOUTS ... 56 CHANGING ALARM LIMITS ... 56 CHANGING ALARM PRIORITY ... 56 ELECTROCARDIOGRAM ALARMS: HEART RATE ... 57 ELECTROCARDIOGRAM ALARMS: HEART RATE FOR S12/S19 PATIENT MONITORING ... 57 ELECTROCARDIOGRAM ALARMS: CARDIAC ARREST ... 57 VENTRICULAR TACHYCARDIA ALARM ... 57 ST ALARMS ... 58 EXTENDED ARRHYTHMIA ALARMS ... 58 RESTING ECG ... 58 SPO2 ALARMS ... 59 TECHNICAL ALARMS ... 59 PROTOCOL EVENTS ... 59

10.

AVERAGES ... 60

REFERENCE ... 61 MARKERS... 61 ST VALUES ... 61 OTHER DISPLAYED INFORMATION ... 61 11.

TRENDS ... 62

TREND SELECT... 62 DUAL TRENDS ... 62 ALL ST TRENDS ... 64 12.

TRACES ... 65

PROTOCOL TIMERS ... 66 ACCESS POINT... 66 ST VALUES ... 66 QT/C VALUES ... 67 ARRHYTHMIA VALUES... 67 SPO2 VALUES... 67 S12/S19 NUMERIC PARAMETER VALUES ... 67 LEARN ... 67 ECG GAINS ... 68 WAVEFORM GAINS ... 69 SHOW 10 MM/S ... 69 13.

REVIEW ... 70

MULTI-PATIENT REVIEW ... 70 SINGLE-PATIENT REVIEW ... 71 EVENT REVIEW ... 71 TREND REVIEW ... 72

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TABLE OF CONTENTS

NAVIGATION TO DAY AND TIME ... 72 SELECT TREND FOR WAVEFORM TRACES DISPLAY ... 72 NAVIGATION WITHIN THE REVIEW ECG ... 73 GAIN ... 73 MULTI (TRACES), 12-LEAD AND CUSTOM DISPLAY... 73 GRAPHICAL TRENDS REVIEW ... 74 ST TRENDS REVIEW ... 75 TABULAR TRENDS REVIEW ... 76 PRINT ... 77 SETTINGS ... 77 RELOAD ... 78 ALARM EVENTS LIST ... 78 ALARM EVENTS FILTERING... 78 14.

PATIENTS... 79

NEW ... 79 MODIFY ... 79 DELETE ... 79 ARCHIVE ... 80 SESSION MANAGEMENT ... 80 15.

SYSTEM CONFIGURATION ... 82

BEDS ... 82 PRINTERS ... 83 VOLUMES... 83 ALARMS... 84 DISPLAY ... 84 SIGNAL PROCESSING ... 85 PASSWORDS ... 85 MANAGEMENT ... 85 IMPORT/EXPORT ... 85 DELETE SAVED PROFILES, ID FORMATS, AND PROTOCOLS... 86 USER SETUP ... 86 SHUTDOWN OR REBOOT NODE ... 86 16.

TROUBLESHOOTING FOR THE CLINICIAN... 87

17.

VERITAS ADVANCED ECG ALGORITHMS ... 90

HOW TO OPTIMIZE PERFORMANCE ... 90 18.

ALARM DETAILS... 92

19.

TELEMETRY MONITORING PRINTOUTEXAMPLES ... 96

12-LEAD ECG WITH INTERPRETATION, 4×3+1 FORMAT WITH GRID ... 96 12-LEAD ECG WITH INTERPRETATION, 4×3+3 FORMAT WITH GRID ... 97 12-LEAD ECG WITHOUT INTERPRETATION, 6×2 FORMAT WITH GRID ... 99 SINGLE LEAD ECG, NO GRID ... 100 RHYTHM (USER-DEFINED LEADS AND PARAMETERS) WITH GRID ... 101 RHYTHM (USER-DEFINED LEADS AND PARAMETERS) WITHOUT GRID... 102 TREND – PAGE 1: ST CHANGE, HR, AND ECTOPY ... 104 TREND – PAGE 2: ST CHANGE HR, ECTOPY, INTERVALS, QT AND QTC ... 105 REVIEW SCREEN PRINT, SAMPLE 1: 180 SECONDS OF LEADS II, III, V1, AND V5 ... 106 REVIEW SCREEN PRINT, SAMPLE 2: 780 SECONDS OF LEAD II ONLY ... 107 REVIEW SCREEN PRINT; SAMPLE 3: 12-LEAD ECG AT 10 MM/S ... 108 AUTOMATIC PROTOCOL PRINTOUT ... 109 END OF SHIFT REPORT ... 110

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TABLE OF CONTENTS

20.

TECHNICAL SPECIFICATIONS ... 115

APPLIED STANDARDS ... 115 SPECIFICATIONS ... 116 NETWORK ... 120 SIZE ... 120 WEIGHT... 120 SCREEN... 120 PRINTER... 121 ELECTRICAL CHARACTERISTICS ... 121 WORKSTATION COMPUTER ENVIRONMENTAL CONDITIONS... 123

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3. SAFETY INFORMATION WARNING:

Means there is the possibility of personal injury to you or others.

Caution:

Means there is the possibility of damage to the device.

Note:

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

Safety Regulations Surveyor Central and Surveyor Central Repeater are medical devices labelled, according to European directive 93/42/EEC (MDD), as a class IIb and class I medical devices respectively. Telemetry transmitters are produced by Welch Allyn, and marked

per the MDD directive. Various other accessories, like the monitor and printer are

marked by the respective manufacturers according to the applicable European directives. See respective declarations of conformity for details. Surveyor Central cannot be classified as Medical Electrical Equipment according to the definition of safety standard IEC 60601-1. The Surveyor Central, together with all accessories that have a physical or logical connection with it, forms part of a Medical Electrical System. The Surveyor Central complies with various safety and performance regulations as mentioned in Appendix E.

Warnings 

This manual gives important information about the use and safety of this system. Deviating from operating procedures, misuse or misapplication of the system, or ignoring specifications and recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the system.



Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this system. Before attempting to use this system for clinical applications, the operator must read and understand the contents of the user manual and other accompanying documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and bystanders, or damage to the system. Contact Welch Allyn service for additional training options.



The Surveyor Central is not designed to be used in the environment where the patient is undergoing a medical procedure as defined in IEC 60601-1 (1.5 m from the patient). The use of an isolation transformer between mains and Surveyor Central is required but is not a sufficient safety measure for use in the patient environment because of data connections (data network) that might cause excessive leakage currents in some conditions. Additional separation devices may be required. Any equipment that has a physical connection between Surveyor Central and that is in the patient environment must have additional protection against electrical shock (e.g., a separation device between the equipment and Surveyor Central) in order to be in compliance with IEC 60601-1 or equivalent safety standards.



The Surveyor Central is not battery operated. For uninterrupted use, an appropriate uninterruptible power supply (UPS) is required. The WiFi network (telemetry) as well as any active network components such as switch and firewall should also have the capability to remain operational in cases of general power outages. The Surveyor Central is designed to continue operation with the last stored settings after a power interruption, however, loss of stored data is possible if power is interrupted to the system that stores the data. When using a backup power source such as a UPS, periodically check it to ensure it is properly functioning per the manufacturer’s recommendations and specifications.

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SAFETY INFORMATION



In order to be safely used, all accessories (such as 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 various parts of a Surveyor Central monitoring system (Telemetry receiver computers, control and display computers, storage computers, printers, or bedside monitors) are all connected through a specific Ethernet data network. This network must be installed according to all applicable standards and may only be logically or physically connected to the outside world through a specific routing device available from Welch Allyn. Any other data path can lead to serious security risks and interruptions of monitoring. Other devices must not be connected to the Surveyor data network.



Connection of the Surveyor Network along with its associated transmitters and monitors to the IT Network in a healthcare delivery organization may carry risks to patients, operators as well as 3 rd parties. Such risks must be carefully assessed and mitigated. The IEC 80001-1:2010 standard provides guidance to the healthcare delivery organization for carrying out such risk assessment and mitigation. Changes to the IT Network can also introduce new risks which should be carefully assessed and planned.



The Surveyor Central, as all medical equipment or systems, 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. Refer to the specific EMC instructions in this manual.



In the case of a Surveyor Central system with additional control stations for display and control of the same patient channels in multiple locations, silencing or suspending of alarms will cause the alarm to be silenced or suspended at all the locations. Be certain that alarms are silenced or suspended by the clinician having direct responsibility for care of the given patient.



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



Install all computer equipment with adequate space around ventilation vents. Clean and remove accumulated dust on ventilation openings, and also remove dust regularly from the inside of the system. The last operation must be performed by adequately trained and authorized personnel, and with the system turned off.



Install the computer that generates the alarm sounds in such a way that the sound can be heard adequately in the appropriate areas. The speaker is installed on the front panel of the computer.



The Surveyor Central provides an alarm volume adjustment. Be sure to set the volume at a level that alarms can be heard above the ambient noise level in the environment of use. Setting alarm volumes too low can impede recognition of alarm signals.



The hardware watchdog device is connected to the computer with a USB cable and has its own power supply. Mount it in such a way that the sound can be heard adequately in the appropriate areas. Test regularly by temporarily removing the USB plug while the central station power is turned on.



The Surveyor 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.



The Surveyor Central requires more than one mains outlet. Fix multi-socket outlets properly, do not leave them on the floor, and organize the cabling in such a way that normal work is not hampered and safety is not compromised.



Regularly check all mains power cables for damage and proper connection. Do not use equipment with a damaged power cord.

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SAFETY INFORMATION



The Surveyor Central components are not waterproof. Avoid spillage of liquids from penetrating the system or submersion of components and transmitters into a liquid. In case of accidental spillage, turn device off and let dry thoroughly.



The various manufacturers of accessories provide separate user manuals (e.g., monitor, laser printer, Surveyor S12/S19, Surveyor S4, patient cables, electrodes). Read these manuals well and refer to them for specific functions. It is recommended to keep all manuals together. Refer to these manuals for a list of approved accessories. When in doubt, contact Welch Allyn.



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



Do not disassemble the equipment as hazardous voltages may be present within. Contact Welch Allyn or an affiliated service representative for repairs.



Technical and service documents are available upon request.



Always turn the system off before connecting or disconnecting any cables.



Do not use the system in places that are susceptible to explosion hazard or in the presence of flammable gases.



Do not use the system in the presence of Magnetic Resonance Imaging (MRI) equipment and tomography equipment.



Do not insert a bootable CD/DVD on the Surveyor Central computers. Do not run any program from CD/DVD or USB memory sticks. These I/O devices should only be used for export and import of patient ID formats, profiles and protocols.



Surveyor Central computers contain a small lithium battery for maintaining clock and BIOS settings which should normally last the lifetime of the system. If the battery needs to be replaced, be sure that it is done by qualified personnel and with a battery of the same type.



Surveyor Central software has been extensively tested and clinically validated. Several protection mechanisms against software errors have been built into the Surveyor Central; however, in the unlikely event of a failure of the software or the computer processor, the electronic (hardware) “watchdog” of the Surveyor Central sounds a continuous loud beep and the Central station has to be power-cycled to remove this. Please inform Welch Allyn service personnel for further troubleshooting should this continuous loud beeping occur.



Surveyor Central hardware has been carefully selected for reliability; however, in mission critical situations, it might be advisable to have a backup system available at short notice. This also includes accessories such as patient transmitters and monitors which, by nature and way of use, can be more prone to failure.



Installation and connection to data networks must be performed by properly trained personnel, authorized by Welch Allyn, Inc.



To maintain designed operator and patient safety, use only parts and accessories supplied with the system and available through Welch Allyn, Inc.



The equipment described in this manual has an expected lifetime of five years from the date of manufacture. Operation beyond this expected life may not meet specifications. This lifetime is only valid if devices are used according to the instructions in this manual and associated manuals provided with the equipment.

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SAFETY INFORMATION



The system captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis. The system is optionally equipped with Welch Allyn’s VERITAS™ 12-lead resting ECG interpretation algorithm. When this option is enabled, the VERITAS ECG algorithm can provide an over-reading physician with a silent second opinion through diagnostic statements output on the ECG report. For additional information on the Welch Allyn VERITAS 12-lead resting ECG interpretation algorithm, please refer to the Physician’s Guide to ECG Interpretation.



12-lead ECGs acquired through Surveyor Central or attached monitors will normally use a modified lead system with the limb electrodes positioned on the torso. Although this is a generally accepted practice (e.g., in stress testing), the different electrode positions can cause morphology changes on the ECG, thus influencing their interpretation. Most frequently seen differences are a vertical and rightward axis shift, minor changes of evidence of old inferior infarction and changes in the T-wave in the limb leads. All 12-lead ECGs printed with Surveyor Central have a warning message that alerts the physician that the ECG might have been acquired with torso positioned limb leads. It is recommended that you place the electrodes as close as possible to the normal limb positions avoiding the possibility of causing artifact. The right arm and left arm electrodes should be placed on the clavicles as close as possible to the arms. The left leg electrode should be placed as close as possible to the left leg without subjecting it to the possibility of motion artifact.



The minimum amplitude for detecting QRS complexes is user selectable between 160, 300 and 500 µV. A low value of this limit has the risk of detecting P waves as QRS complexes in the case of atrio-ventricular block; however, a high value might lead to false cardiac arrest alarms if the QRS amplitude is low in all leads. Therefore, the user is encouraged to select detection leads with amplitude of at least 1 mV and set the minimum QRS amplitude at 300 µV.



During periods of lead fail and when a reduced lead set is used for patient monitoring, 12-lead resting ECG interpretation cannot be reliably used in determining a diagnosis.



When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.



The quality of the signal produced by the system may be adversely affected by the use of other medical equipment connected to the patient including, but not limited to, defibrillators and ultrasound machines.



If the system or one of its subsystems become inoperable during monitoring, a medium or low priority type alarm sounds and a message is displayed on the screen. In case of hardware or software failure that causes the sound generator or display subsystem to fail, the hardware watchdog unit generates a continuous beep. Periodic checks of the monitoring screen are recommended to ensure proper functioning.



The LCD supplied with the Surveyor Central has a separate power switch and power-on indicator. If no image appears on the screen, check the LCD power indicator. Alarm sounds are not affected by the status of the LCD. Do not connect a sound-capable display monitor such as a LCD TV to the Surveyor Central.



The on/off switch of the Surveyor Central is deactivated and can only be used for emergency power down by depressing it for a period greater than 4 seconds. Normal shutdown of the Surveyor Central should be done by using the password-protected configuration window.



Do not use excessive force on any of the connection cables and handle all accessories with care.



Various alarm conditions require operator set limits that vary per patient. For telemetry monitoring, Surveyor Central supports the selection of appropriate alarm profiles when a patient is admitted. The operator should check these settings after each patient admission to ensure whether the chosen alarm limits are appropriate for the individual patient. Inappropriate alarm limits render the alarm system useless.

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SAFETY INFORMATION



Saved profiles are only applicable to the type of cable and detection leads in use when the profile was defined. If another type of cable is used with a saved profile, the default detection leads will be utilized.



In any single environment such as an intensive care unit or cardiac operating theater, a potential hazard can exist if different alarm preset values are used for the same or similar equipment.



Portable and mobile RF communications equipment can affect medical electrical equipment or systems as well as the Surveyor Central and its accessories.



Surveyor Central alarms can only be silenced and not reset. This means that visual representation of an alarm condition remains present after an operator silenced action until the alarm condition disappears (unless obscured by another, higher priority, alarm). The auditory alarm signal does not re-activate after a silence action if the alarm condition remains the same. As soon as the alarm condition of a silenced alarm goes away, the alarm can be reactivated.



The Surveyor Central alarm system can be globally disabled or suspended for a period of time for a patient. The selection between disabling and suspending, as well as the suspension duration, can be set in the passwordprotected system configuration page. A clear visual indication of this condition is present in the patient window, and a reminder signal sounds every three minutes. Any technical alarms will be visually presented on the screen, regardless of the alarm disabled state. In this configuration the technical alarms will not be audible.



The intended use of Surveyor Central Repeater is to repeat waveforms, parameters and system status of selected patients monitored by Surveyor Central in order to enhance workflow for medical personnel. Surveyor Central Repeater does not produce audible alarm signals and may not be used to substitute any alarm functions of Surveyor Central.



This manual applies to the most recently manufactured system, with respect to software release and hardware configuration. Whenever used for software upgrades on previously installed equipment, some technical specifications or labels may not be respected, whereas functions and instructions for use of the system are always valid. This user manual reflects software version 5.1.0.

The following warnings concern telemetry monitoring: 

Electrostatic discharges may generate short interference on the ECG tracings.



WiFi Telemetry: The Surveyor S4 utilizes standard WiFi telemetry per the IEEE 802.11g/n standard. The WiFi network supporting the Surveyor S4 and for use with the Surveyor Central must be installed and tested in accordance to Welch Allyn’s guidance and network requirements. Also refer to Welch Allyn’s Manufacturer Disclosure Statement for Medical Device Security (MDS2) documents for the Surveyor Central and Surveyor S4. Welch Allyn and/or 3rd party partners are available to perform network site surveys and audits to confirm the suitability of the facility’s WiFi network for use with the S4 mobile monitor and connection to the Surveyor Central and its Surveyor Network.



The system was not designed to be used with high frequency (HF) surgical devices.



Use of transmitters and monitors may be restricted in some countries; see the transmitter’s and monitor’s user manuals for details.



Consult the Surveyor S12/S19 and Surveyor S4 user manuals for more information regarding the patient cable, electrode recommendations, cleaning, maintenance, channel frequencies, precautions to take during patient defibrillation, and other warnings.

The following warnings concern pulse oximetry (SpO2) telemetry monitoring: 

Pulse oximetry sensors must be checked a minimum of every 4 hours and moved to a new site as necessary.

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SAFETY INFORMATION



Pulse oximetry sensors are susceptible to high ambient light interference including ambient photodynamic therapy. Shield the sensor area as necessary.



SpO2 measurement may be adversely affected by dyes (e.g., methylene blue, indocyanine green, indigo, carmine, fluorescein) introduced into the bloodstream.



Any condition that restricts blood flow such as the use of a blood pressure cuff or extremes in systemic vascular resistance may cause inability to determine accurate SpO2 readings.



Certain conditions such as physical movement (patient and imposed motion); diagnostic testing; low perfusion; electromagnetic interference; electrosurgical units; dysfunctional hemoglobin; and inappropriate positioning of the pulse oximeter sensor may result in pulse oximetry readings that are unreliable.



SpO2 signal inadequacy is indicated by error messages displayed on the LCD of the transmitter and by alarms generated at the Surveyor Central system for signals coming from the transmitter.



The performance of the monitor may be compromised by excessive motion.



Nail polish and/or artificial fingernails can affect the accuracy of pulse oximetry and should be removed.



The pulse oximeter equipment is calibrated to display functional oxygen saturation.



Functional SpO2 testers (simulators) are useful to measure how accurately a particular monitor is reproducing the calibration curve but cannot be used to assess the accuracy of a type of probe or monitor. If there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor to the total error of a monitor/probe system. The functional tester can then measure how accurately a particular pulse oximeter monitor is reproducing that calibration curve.



If no SpO2 or pulse rate is present, alarm conditions are provided at the Surveyor Central system. There is no alarm condition provided at the transmitting device.



For additional instructions and warnings, refer to the user manual of the transmitting device.

The following warnings concern heart rate for telemetry monitoring: 

Heart rate indication is usually not affected by ventricular or supraventricular arrhythmias or irregular heart rates. Heart rate is calculated over 16 beats at rates over 40 bpm and 4 beats at lower heart rates. This results in a response time of 9 seconds or less when the heart rate changes suddenly from 80 bpm to 40 or 120 bpm, as measured according to IEC 60601-2-27.



High heart rate and low heart rate alarms cannot be disabled.



Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor Central rejects tall T-Waves less than or equal to 230% of a 1 mV QRS measured according to IEC 60601-2-27.



The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in IEC 60601-2-27, Figure 201.101, patterns A1-A4, if the QRS amplitudes exceed the minimum detection threshold set by the user.



Time to low heart rate, high heart rate and asystole, as measured according to IEC 60601-2-27, is less than 10 seconds.



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

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SAFETY INFORMATION



The summarized performance of the QRS recognition and classification algorithm on standard databases, as defined by ANSI/AAMI EC 57, is as follows: MIT Database Performance Measures

Welch Allyn

QRS Detection Sensitivity %

99.93

QRS Detection Positive Predictivity %

99.87

PVC Detection Sensitivity %

95.13

PVC Detection Positive Predictivity %

97.04

PVC Detection False Positive Rate %

0.220 AHA Database

Performance Measures

Welch Allyn

QRS Detection Sensitivity %

99.78

QRS Detection Positive Predictivity %

99.91

PVC Detection Sensitivity %

93.15

PVC Detection Positive Predictivity %

98.40

PVC Detection False Positive Rate %

0.154



Because of noise, artifact and the many different physiological manifestations of the ECG signal, it is inevitable that some beats are not detected or correctly classified by the system. The user is advised not to rely completely on automatic alarm systems for the monitoring of critical patients.



Excessive patient movement could interfere with the operation of the system.



Proper patient preparation is important to proper application of ECG electrodes and operation of the device.



If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s) where this condition is present and if the signal is being displayed or printed, the respective lead(s) will print out as square waves. A lead fail alarm is generated on the Surveyor Central.

The following warnings concern pacemaker patients for telemetry monitoring: 

Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon heart rate meter ALARM SIGNALS. Keep pacemaker PATIENTS under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument.



With the Surveyor S4 when used with the 4-wire, 5-wire or 10-wire ECG cable, all pacemaker spikes are rejected per the IEC 60601-2-27 standard (0.1 - 2 ms duration, 2 - 700 mV amplitude). Signals are recognized as pacemaker spikes when they have a slew rate over 4 V/s, as measured according to the IEC 60601-2-27 standard. Abnormally high or wide pacemaker spikes might be recognized as QRS if their amplitude and pulse width exceed these values.



With the Surveyor S4 when used with the 3-wire ECG cable, pacemaker spikes are not rejected consistently. For this reason, do not rely upon heart rate meter ALARM SIGNALS, when using a 3-wire cable.



Welch Allyn does not claim, verify, or validate support for all available pacemakers.



Consult the Surveyor S12/S19 User Manual for a description of its pacemaker spike rejection capabilities.



The Pacemaker Rejection software can be deactivated by the user. This should not be done for patients with a pacemaker or suspected to have a pacemaker implanted because this can lead to a heart rate indication and failure to alarm for cardiac standstill.

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SAFETY INFORMATION



Other than the influence on beat detection as stated above, there is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the system.

Notes 

Surveyor Central contains electronic records including ECG’s which can be exported to other applications. The Surveyor Central system can be part of a system that is compliant with the electronic records requirements of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) as stipulated by the US Food and Drug Administration's (FDA). The user of the Surveyor Central system must ensure full compliance to this as required.



Compliance with applicable privacy and data protection guidelines, such as HIPAA in the United States and Directive 95/46/EC of the European Parliament and the Council, plus any other local regulations and policies are the ultimate responsibility of the entity deploying and using the Surveyor Central. The Surveyor Central system implements certain features such as username/passwords and audit trails. By-design, the system is accessible and available for use upon power-up. The facility deploying and using the system is responsible for ensuring appropriate safeguards are put in place to protect patient health information (PHI). This includes a mixture of physical and IT-based mechanisms to secure PHI from unauthorized access. The Surveyor Central Station including printers generating reports must be placed in a physical location that is secure (e.g., nurse’s station). Surveyor Review and Repeater stations may be placed in less secure locations but must implement proper username/password access policies as required.

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4. EQUIPMENT SYMBOLS AND MARKINGS WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document. CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data.

Direct Current (DC) power input

Indicates compliance to applicable European Union directives

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

Network connection

Universal Serial Bus (USB) port

Output terminal

Mouse Connection

ON (Power) Serial Port Connection

Keyboard Connection

Follow instructions/directions for use (DFU) -mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Parallel Port Connection

Reorder Number

Medical Device Model Identifier

Product Lifetime Welch Allyn intends to support the Surveyor Central Processing Unit, monitors, transmitters and proprietary antenna network components most current version, for not less than three (3) years beyond the date of the last unit produced of that revision, or for as long as parts, accessories and expertise are available from our vendors, subject to last time buys and technology obsolescence.

15

5. ELECTROMAGNETIC COMPATIBILITY Electromagnetic compatibility (EMC) with surrounding devices should be assessed when using Surveyor Central. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on a representative Surveyor Central configuration, which included an Uninterruptable Power Supply (UPS) and was executed 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). WARNING: Surveyor Central should not be used adjacent to, or stacked on top of other equipment. If Surveyor Central must be used adjacent to or stacked on top of other equipment, verify that Surveyor 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 for recommended separation distances between the radio equipment and Surveyor Central. WARNING: The use of accessories and cables other than those recommended by Welch Allyn may result in increased emissions or decreased immunity of the transmitter. Please note the emissions and immunity declaration tables that follow.

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ELECTROMAGNETIC COMPATIBILITY

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The Surveyor Central System is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the Surveyor Central System should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment: Guidance

RF Emissions CISPR 11

Group 1

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

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Not Applicable

The system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Not Applicable

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The Surveyor Central System is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the Surveyor Central System should ensure that it is used in such an environment. Emissions Test

Compliance

Compliance Level

Electromagnetic Environment: Guidance

Electrostatic discharge (ESD) IEC61000-4-2

+/- 6 kV contact +/- 8 kV air

+/- 6 kV contact +/- 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 IEC 61000-4-4

+/- 2 kV for power supply lines +/- 1 kV for input/output lines

+/- 2 kV for power supply lines +/- 1 kV for input/output lines

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

Surge IEC 61000-4-5

+/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth

+/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth

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

Voltage fluctuations and interruptions

<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”if a UPS is not used.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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.

NOTE: UT is the AC Mains voltage prior to application of the test level.

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ELECTROMAGNETIC COMPATIBILITY

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The Surveyor Central System is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the Surveyor Central System should ensure that it is used in such an environment. Emissions Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the system, 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

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

d = 1.2

d=

80 MHz to 800 MHz

d=

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 the Surveyor Central and WiFi-based telemetry transmitters for its intended function (see transmitter user manual). a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, 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 the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment 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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