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

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

EU IMPORTER 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. Page | 1

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. Page | 2

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 Page | 3

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 Page | 4

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 THECLINICIAN...........................................................................................................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 Page | 5

TABLE OF CONTENTS 20. TECHNICALSPECIFICATIONS............................................................................................................................115 APPLIED STANDARDS ....................................................................................................................................................... 115 SPECIFICATIONS.............................................................................................................................................................. 116 NETWORK ..................................................................................................................................................................... 120 SIZE ............................................................................................................................................................................. 120 WEIGHT........................................................................................................................................................................ 120 SCREEN......................................................................................................................................................................... 120 PRINTER........................................................................................................................................................................ 121 ELECTRICAL CHARACTERISTICS ........................................................................................................................................... 121 WORKSTATION COMPUTER ENVIRONMENTAL CONDITIONS..................................................................................................... 123 Page | 6

3. SAFETY INFORMATION

WARNING: Caution: Note: Safety Regulations

Means there is the possibility of personal injury to you or others. Means there is the possibility of damage to the device. Provides information to further assist in the use of the device.

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 3rd 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. Page | 8

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. Page | 9

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. Page | 10

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. Page | 11

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 lessthan 10 seconds.  Heart rate indication is not reliable during episodes of ventricular fibrillation. Page | 12

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:

Performance Measures QRS Detection Sensitivity % QRS Detection Positive Predictivity % PVC Detection Sensitivity % PVC Detection Positive Predictivity % PVC Detection False Positive Rate %

MIT Database Welch Allyn 99.93 99.87 95.13 97.04 0.220

Performance Measures QRS Detection Sensitivity % QRS Detection Positive Predictivity % PVC Detection Sensitivity % PVC Detection Positive Predictivity % PVC Detection False Positive Rate %

AHA Database Welch Allyn 99.78 99.91 93.15 98.40 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 msduration, 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. Page | 13

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. Page | 14

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

Serial Port Connection

ON (Power)

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. Medical Device Model Identifier

Parallel Port Connection Reorder Number

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. Page | 16

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 RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2

Compliance Group 1 Class A Not Applicable

Electromagnetic Environment: Guidance 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. 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 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage fluctuations and interruptions Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

+/- 6 kV contact +/- 8 kV air +/- 2 kV for power supply lines +/- 1 kV for input/output lines +/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth <5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles < 5% UT for 5s 3 A/m

+/- 6 kV contact +/- 8 kV air +/- 2 kV for power supply lines +/- 1 kV for input/output lines +/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth <5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles < 5% UT for 5s 3 A/m

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 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. Note that monitoring is interrupted at the level “< 5% UT for 5s”if a UPS is not used. 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.

IEC 60601 Test Compliance

Emissions Test Level

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

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 Vrms 150 kHz to 80 MHz 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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ELECTROMAGNETIC COMPATIBILITY

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the System The Surveyor Central Systems is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Surveyor Central System can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Surveyor Central System as recommended in the table below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter (W) 0.01 0.1 1 10 100

Separation Distance According to Frequency of Transmitter (m)

150 KHz to 80 MHz 𝑑 = 1.2√𝑃 0.1 m 0.4 m 1.2 m 4.0 m 12.0 m

80 MHz to 800 MHz 𝑑 = 1.2√𝑃 0.1 m 0.4 m 1.2 m 4.0 m 12.0 m

800 MHz to 2.5 GHz 𝑑 = 2.3√𝑃 0.2 m 0.7 m 2.3 m 7.0 m 23.0 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTE: For RF transmitters that radiate around the working band of the telemetry transmitters interference can occur also at shorter distances. NOTE: For EMC assessment, essential performance was absence of disruption of the operation of the SC System, and, in particular, maintaining HR accuracy to no more than ±10% deviation, and continued function of alarms during and after the test.

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6. INTRODUCTION Purpose This user manual explains how to:  Use and understand Surveyor™ Central, Surveyor Central Repeater, and available options  Enter, modify, and delete information  Perform common operator tasks NOTE: This manual may contain screen shots. Any screen shots are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording. 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. Intended Use The Surveyor Central Station system is intended for monitoring of physiological signs, including cardiac and vital signs, for multiple patients within a medical facility. The system can receive, display and store data from up to a maximum of 64 multi-parameter patient monitors, mobile monitors, and/or telemetry systems. The system can support patient monitoring and telemetry monitoring modes simultaneously. Patient monitors can be Surveyor S12 or S19 patient monitoring systems. Ambulatory telemetry transmitter and mobile monitor sources can be Surveyor S4 systems. In patient monitoring mode, the patient monitors provide primary monitoring functionality while the Surveyor Central Station system provides continuous secondary monitoring of patients including alarm reception and management, display and storage of parameters and waveforms including full-disclosure, automatic and on-demand generation of various printed reports using a network-attached printer. In telemetry monitoring mode, the Surveyor Central Station provides primary monitoring of patients including display of values and waveforms, alarm generation and management, data storage, patient management and report printing functionality. Patients are 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 data and analysis provided by the Surveyor Central Station is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various conditions. Indications for Use The Welch Allyn Surveyor Central Station is indicated for use in adult and pediatric patient populations.  In a clinical setting, by qualified medical professionals, properly trained for patient 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.  Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Page | 20

INTRODUCTION

Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.  Chest Pain Evaluation.  Evaluation of patients with pacemakers.  Evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)  Evaluation of monitored parameters documenting therapeutic interventions in individual patients or groups of patients.  Clinical and epidemiological research studies. System Description

The Surveyor Central can perform telemetry monitoring using the Surveyor S4 integrated with the healthcare delivery organization’s WiFi network infrastructure. The Surveyor Central is also designed to communicate with the Surveyor S12/S19 multi-parameter patient monitors.

Its intended functions include:  Real-time, 3-wire (1-lead), 5-wire (7-lead) and 10-wire (12-lead) diagnostic ECG signal display  Real-time SpO2 plethysmographic waveform display  Automatic monitoring of arrhythmias, SpO2 values, and ST changes including one or more displayed waveform channels for each patient  Visual and audible alarms of events, arrhythmias, and set parameters with adjustable priorities  Averaged and reference QRS complexes  Graphical trend review  Single lead or any combination of leads up to 12 for ECG rhythm and report printing  ECG signal and SpO2 data storage with optional full-disclosure storage and review  When the patient device is a Surveyor S12/S19 monitor, additional parameters may include non-invasive blood pressure (NIBP), impedance respiration, invasive pressures (P1-P4), Temperature (T1, T2), end-tidal and inspired CO2, and cardiac output (CO).

Through telemetry, patients using ambulatory transmitters are monitored while moving in a designated area. To guarantee proper signal transmission in various situations, install an antenna network as per facility requirements.

The Surveyor Central Station communicates with the Surveyor S12/S19 patient monitors through a Local Area Network (LAN) interface. The Surveyor Central network can distribute patient data to one or more Surveyor Central control stations in a single or dual display mode.

Each Surveyor Central receiving workstation will acquire data. Connect multiple Surveyor workstations to the same Surveyor Central network to allow realtime patient monitoring in a variety of different system configurations (see following page).

Control, viewing, receiving signals, and data storage are all possible on a single Surveyor Central workstation. Control, viewing, receiving signals, and

Figure 1 – An example of Surveyor Central configured with dual displays.

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INTRODUCTION data storage can also be achieved using separate workstations for each function--or a combination of functions--on the Surveyor Central network. Networked printers are used for automatic or manual printouts of 12-lead ECG, ECG rhythm, plethysmographic waveform with % SpO2 and pulse rate, and reports. An optional redundant storage server is available for increased storage capacity as well as storage to duplicate data disks when continuous and complete ECG capture is critical. This is valuable for institutions that collect ECG data for research purposes. This capability may also be important for other medical facilities. The Surveyor Central system provides the means for users to manage patient records with associated patient demographics and assign each to a particular patient monitor or telemetry system for obtaining physiological information. Physiological data obtained from patient monitors and telemetry devices are viewable and stored continuously with a minimum storage timeframe of 72 hours. Alarm monitoring and management, including definition of alarm limits, as well as data trending and reporting are available. Full disclosure supports review of the data on a particular patient including review of 12-lead ECG waveforms and other data and waveforms for obtained parameters. Surveyor Central with WiFi telemetry Figure 2 - A Surveyor Central configuration with WiFi telemetry using Surveyor S4 mobile monitors. Surveyor Central with Multiple Control of Same Channels Additional control stations are available for display and control of the same patient channels in multiple locations. Channel allocation for multiple control stations is defined during installation and setup. Surveyor Central USB-WATCHDOG Surveyor Central is intended for continuous use. A Watchdog is externally connected to a USB port and emits a loud and continuous audible alarm in case of system failure. A Watchdog is a required and necessary part of every control workstation. Page | 22

Top view

Side connections

INTRODUCTION

Figure 3 - Top and side view of the Surveyor Central USB watchdog device. Optional System Components  Single color displays: A single 24” LCD display optimally supports up to 16 or a maximum total of 32 telemetry and patient monitoring slots.  Dual color displays: A 24” dual LCD display optimally supports up to 32 or a maximum total of 64 telemetry and patient monitoring slots.  Single, touch-enabled color display: A single 24” LCD display optimally supports up to 16 or a maximum of 32 telemetry and patient monitoring slots; with touchscreen function.  Keyboard/mouse switch: Allows one keyboard and mouse to control up to 4 nodes, with their displays configured to seamlessly produce one large virtual desktop.  Surveyor Central control station: A workstation with single or dual display on the Surveyor Central network for purposes of controlling and viewing a set of monitored channels at a designated location within the facility.  Surveyor Central receiving station: A workstation connected to the healthcare delivery organization’s WiFi network through a firewall router for the purposes of receiving transmitted signals from Surveyor S4. As required, the receiving station produces a set of channels for viewing or storage at another location on the Surveyor Central network.  Surveyor Central receiving and control station: A workstation with single or dual display connected to the transmitters and monitors for purposes of receiving transmitted signals to produce, display, and control a set of monitoring channels. Data storage is accomplished at another location on the Surveyor Central network.  Redundant data storage: Stores real-time data and simultaneously copies the data to a set of Redundant Array of Independent Disks (RAID) for increased storage capacity and data security in situations where complete data collection is critical. All system data storage for workstations on the Surveyor Central network is performed at this networked server when it is a component of the Surveyor Central.  Surveyor Central repeater station: A display station where monitoring channels are repeated and can be displayed, printed, and reviewed. Alarms are visual only and are not audible or controlled at the repeater station.  Network printer (print server): The printer must be plugged into the AC power outlet through the appropriate power cord that is in compliance with local regulations. Please refer to the printer manufacturer’s user manual for information, warnings, commands, and intended use. Page | 23

INTRODUCTION System Software Options  Full disclosure for continuous data storage: All patient monitoring data is available for review when this option is enabled. The storage amount is dynamic and relies on the number of channels utilized in relation to the size of the storage space. Each day of a patient’s data is equal to approximately 0.5 GB. Divide number of storage days by number of monitored patients to calculate number of days for each monitored patient (i.e., 600 days of storage ÷ 10 monitored patients = 60 days per patient). This option also allows off-line archive to a network directory or DVD media. Data can be acquired by Welch Allyn’s HScribe™ Holter analysis system for further review, rhythm quantification, Holter reporting, and/or 12-lead ECG collection which can then be exported in XML or Unipro format. When this option is not enabled, one minute of ECG data surrounding each event or alarm is stored for review, ECG printing, and export.  Protocol manager: Only available for Telemetry channels. Allows the clinician to design automatically-timed reminder events, automatically generate printed ECGs, and/or export resting 12-lead ECGs. This is particularly useful to clinicians that perform ECG data collection and must remember to execute certain functions at specific times. The application allows the clinician to program the times for such events to automatically occur. Several different protocols can be designed and the desired protocol can be selected during the patient monitoring sessions. Protocols can also be programmed in phases started by the Surveyor Central station user or by pressing the call button on the transmitter.  Extended arrhythmia and 12-lead ST monitoring: In addition to standard lethal arrhythmia events and alarms, this option allows the clinician to automatically print and capture ventricular ectopy, rhythm patterns, and QRS changes as well as pacemaker failure events. This feature also allows averaged 12-lead ECG display for comparison of the reference ECG superimposed on the current ECG. The reference ECG is used for ST change alarms. Note that not all extended arrhythmias are available with S12/S19 patient monitors.  Resting ECG interpretation: Enables global ECG measurement including QT/QTc calculation and 12-lead ECG interpretation utilizing Welch Allyn’s VERITAS algorithm. 12-lead ECGs can be exported in Unipro format to a network directory or directly to Welch Allyn’s E-Scribe™ data management system. This option is required to enable the ability to use and define E-Scribe custom ID formats. This feature is optional with telemetry only monitoring channels. This feature is always included with Surveyor S12/S19 patient monitoring or a mix of telemetry and S12/S19 patient monitoring.  Review station: Enables patient data review in the Surveyor Central from the online database, as well as patient monitoring data archived from the database to external media. The (separate) Resting ECG Interpretation option is required to enable global measurement and 12-lead ECG interpretation onarchived records. The Surveyor Central review station screen layout is similar to the Surveyor Central review screen in dual-display modality and has the same functionality as the Surveyor Central review features including printouts and export. When networked to the Surveyor Central database, it is possible to initiate archive of patient monitoring data. Please refer to the Surveyor Central Review Station user manual (PN 9515-169-75-ENG) for more detail. Page | 24

INTRODUCTION

Surveyor S12 and S19 Patient Monitors The Surveyor S12/S19 patient monitors are multiparameter patient monitors designed to acquire physiological waveforms and parameters, and to transmit this data to the Surveyor Central monitoring station. Please refer to the Surveyor S12/S19 patient monitor user manual (PN 9515-183-51-ENG) for details.

Surveyor S4 Mobile Monitor The Surveyor S4 is a small, lightweight mobile monitor with a touchscreen designed to acquire ECG and SpO2, and to transmit this data to the Surveyor Central monitoring station via an 802.11g/n wireless network. Please refer to the Surveyor S4 User Manual (PN 9515-190-50-ENG) for details.

Figure 4 - Surveyor S19 Patient Monitor shown with optional printer and wall mount.

Figure 5 - Surveyor S4 Mobile Monitor Surveyor Central with Wireless Access Points Transmission from and to the Surveyor S4 is via the healthcare delivery organization’s WiFi wireless network used for patient data transmission and other system-level communications. When configured with optional 10-wire ECG, the S4 provides continuous 12-lead ECG transmission. Refer to the diagram in this section.

Surveyor Central Network The network for the Surveyor Central allows for the connection and exchange of data between the system components. Ethernet cable is used to connect all devices to the multi-port switch through an internal or external wall connection. All devices are outside of the patient area. WARNING: Do not connect the Surveyor Central Network to computers, devices other than those specified by Welch Allyn, or the Internet, as system operation may be impaired. Consult Welch Allyn or one if its affiliates for information on devices that are approved for use on the Surveyor Central Network. Surveyor Central’s security router is used to isolate the system from the institution network. A secure firewall router is used for any repeater stations or review stations that are located outside of the Surveyor network. Other applications that access Surveyor Central such as Surveyor Import for Holter analysis and remote service support are networked in this way.

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INTRODUCTION

Figure 6 - The Surveyor Central network.

The Surveyor Central repeater station is available as either a dedicated model or standalone software application.

 The dedicated model is installed within the Surveyor network and does not allow user access to any other Microsoft® Windows® programs. It will automatically start when the Surveyor Central is started, the same as any other dedicated node on the system.

 The repeater standalone application contains the same software and can be safely used on a computer on the institution network that meets the minimum specifications listed below and where there is access to the Surveyor security router through LAN or WLAN connection. o Microsoft Windows 7 OS or Windows 10 (64-bit only) o Intel® 2nd Generation Core™ i3 Processor o 4 GB RAM o 250 GB Hard Disk Drive o DVD/CD Drive (for software installation) o Fast Ethernet NIC o 1920 x 1080 Graphics Resolution

In addition, the repeater standalone application can be safely used on a suitable tablet PC’s that meets the minimum specifications listed below and where there is access to the Surveyor security router.

o Microsoft Windows 7 OS or Windows 10 (64 bit only).

o Intel® Core i3 (7 gen) 7130U

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o 4 GB RAM o 128 GB SSD o 10.1” o 1440 × 900 Graphics Resolution

INTRODUCTION

NOTE: In order to meet the declared Repeater standalone application performances, no more than two Repeater standalone applications, with eight patients under monitoring, must be connected to the same access point.

NOTE: In order to meet the declared Repeater standalone application performances, no more than nine Repeater standalone applications must be used at the same time.

NOTE: When connected to Surveyor Central through WLAN connection, the Repeater standalone application performances depend on the customer WLAN connection and its traffic.

The Surveyor Central review station can be networked to the institution network with connection to the Surveyor security router when access to Surveyor Central’s patient database is desired for remote review. The review station can also be installed as a stand-alone and used for review of archived patient monitoring records from media external to the Surveyor Central. Please refer to the Surveyor Central Review Station user manual (PN 9515-169-75ENG) for more detail.

Surveyor Central Connections

Peripheral Workstation Component Interconnect

NOTE: Hardware and connections shown below are subject to change.

12

1 Network printer connection

2 Ethernet network connection

3 not used

10

4 Speaker connection (not used)

5 Keyboard connector

13

6 Display connection (dual support)

7 Dual display cable connected

5

8 not used

9 USB ports 11 10 AC power

9

4 11 Mouse connector

12 Enlarged view

13 Parallel printer port (not used) 1,2

6

8

7

3

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INTRODUCTION WARNING: Always make sure system is turned off before connecting or disconnecting any cable. Installation and Connections Installation must be carried out by a Welch Allyn, Inc. authorized service representative in possession of current service and installation manuals. Surveyor Central requires specific settings based on the number and configuration of transmitters and monitors, the network layout, the type of printer, etc., as well as user preferences. The network laser printer requires specific settings and an installation driver. A package of cables, adapters, wire wraps, and labels are included with the system. Ensure these are available to installation personnel who will connect all accessories safely and in compliance with EMC and local safety requirements. Routine Maintenance and Cleaning Instructions 1. With the system turned off, clean all system components (computer, display, keyboard, mouse, printer, etc…), in accordance with their manufacturer’s instructions. 2. Inspection and preventive maintenance by authorized personnel is recommended every six months. 3. Internal cleaning is recommended by means of a vacuum cleaner or similar device. Cleaning frequency depends on the environment. WARNING: Use of unspecified cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the device. Improper cleaning products and processes can remove important symbols or markings and should not be used. Disposal of Waste Materials Surveyor Central does not contain waste products that require special care for their disposal. Components that have been in intensive or invasive contact with patients (e.g., electrodes) that might have been infected by a transmittable disease should be treated as biological waste products. The disposal of accessories such as electrodes should be carried out according to manufacturer’s recommendations. The device, after its useful life, is considered to be “Waste Electric and Electronic Equipment (WEEE)” which may contain toxic substances. The accumulation of this waste in the environment poses serious risk for the environment and human health. Therefore, WEEE needs to be collected separately and disposed of or recycled in an environmentally-friendly way. Your local administration provides the means to do so, and sanctions are foreseen for unauthorized disposal. Please consult your local regulations on how to dispose of the equipment after its useful life. The producer of this equipment participates actively with the collection and recycling of this equipment. You may return this equipment to your distributor for recycling or disposal. Surveyor Central contains a lithium battery and electronic circuit boards which should not be incinerated or exposed to extreme heat. For your guidance, a list of waste materials is shown below that are related to or contained in the device, according to the EC commission regulation 2557/2001, Annex Part 2, European Waste Code 9 April 2002 directive. Please consult eventual national implementations and later modifications. Page | 28

Waste codes marked with an asterisk are considered to be hazardous waste.

INTRODUCTION

Class UE 16 02 14 20 01 36 16 06 05 20 01 34 15 01 01 20 01 01 15 01 02 20 01 39

Description Discarded electronic equipment not containing hazardous components Other batteries and accumulators Paper and cardboard packaging Plastic packaging

Contact your local waste disposal agency for guidance on the proper recycling or disposal of these components. Respect your local institution regulations in the disposal of any possibly infected accessories like electrodes (waste code 18 01 03*).

Privacy Information The equipment described in this manual is compliant with European directives 95/46/EC and 2002/58/EC on the protection of personal data. Welch Allyn, Inc. or its representatives cannot be considered the “data controller” in the sense of these directives, neither as responsible for processing this data. These functionalities will need to be assigned within the structure of the user organization. It is therefore the duty of the customer to provide the correct storage and handling of data, putting into service all measures foreseen in the mentioned directives or its national implementation. In particular, it is the duty of said customer to regulate access to the parts of the equipment described in this manual that might disclose information concerning a specific identified patient, taking those measures that he considers most suitable to obtain what is mentioned in the directives, providing, for example, rooms with limited access and/or a system of identification for access to the information. The following information is meant to help the user decide which measures to take, taking into account both patient safety and the protection of personal information. Surveyor Central allows the possibility to enter patient name as part of the demographic data. This name can be displayed on the screen of the system, depending on the configuration settings. The name is always displayed on all printouts. Surveyor Central contains a temporary storage area of patient data (including patient name, if entered) meant for review in the context of immediate care, to which access is possible only through Surveyor Central components through the Surveyor data network. It is also possible to copy the data from a monitoring session (including patient name, if entered) to an off-line storage location or device. This data can only be read through specific Welch Allyn software for the purpose of reviewing this data, e.g., on a Holter analysis system or a Surveyor Central review station. It is the responsibility of the user organization to regulate access to these systems and software in compliance with local regulations.

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7. USING THE SYSTEM Turning on the Surveyor Central Workstation The ON/OFF switch is located on the front side of the CPU. When switch is depressed, the workstation will power on. To turn on LCD screen, locate the main switch (usually on the bottom border of the screen). NOTE: The power-up sequence takes about 2 minutes and then the main display appears. NOTE: Always keep the monitor ON/OFF switch in the ON position. If the monitor’s indicator light is not illuminated, press the monitor ON/OFF switch. If the monitor indicator light is illuminated orange, red, or blinking and the monitor is still blank, check the cable connections between the monitor and the base. If an issue persists, contact Welch Allyn, Inc. technical support personnel. Display Screen The Surveyor Central screen is divided into sub-screens, each showing a single patient. The number of traces that are shown depends on how the system is configured. This screen is called the “multi-patient display”. An example is shown in Figure 7. In the multi-patient display, the entire screen displays real-time status of all connected patients including waveforms sent from monitors and/or telemetry transmitters. NOTE: Normally, the waveform traces are drawn smoothly and continuously. Occasionally, you may observe a brief halt followed by the waveform catching up. This is usually due to momentary communication delays through the network between the Surveyor Central and the monitors/transmitters. The system is designed to work through such delays without data loss. However, if this occurs frequently, contact your network administrator or Welch Allyn to check the condition of the network.

Figure 7 - The Surveyor Central multi-patient display screen.

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USING THE SYSTEM Moving the Cursor The on-screen arrow is the mouse cursor used to activate all functions. For example, if you want to acknowledge and silence an alarm, move the cursor with the mouse over the Event/Alarm button (only visible if there is an alarm present) and left click the mouse button. It is not possible to acknowledge and silence alarms from a Surveyor Central repeater station, with the exception of protocol alarms. Multi-patient Display Buttons Buttons in the lower right area of the multi-patient display are active and can be selected by a left mouse click.  Show 10 mm/s is used to toggle all monitored ECG waveforms between 25 mm/s and 10 mm/s speed for all patients.  Patients will open a window that allows pre-admission entry of patient demographics. This window also shows the status of the current monitored patients. Patients is not active for the Surveyor Central repeater station.  When using a Surveyor S12/S19 patient monitor, patient demographic information is communicated bidirectionally between the patient monitor and the Surveyor Central station — demographic information entered at the Surveyor Central station is sent to the patient monitor; demographic information entered at the patient monitor is sent to the Surveyor Central station. Patient data in the patients list can be added or edited allowing pre-admission by selecting New or Modify at the bottom of the display. The appropriate ID Format is also selected from the drop-down list in this window. When finished, select OK to save or Cancel to undo your changes.  Review will open a multi-patient view of all of the current session events for all monitored patients. This allows you to filter, review, and edit all Events/Alarms. More detail will be explained later in this manual. Review is not available at the repeater station.  Config will open a window that requires a password and will then present system configuration menus. The number of available monitoring days in the database memory and current date and time are displayed in the area to the far right. Feedback messages, when present, will appear in the lower left corner on the same status line. An informational message, such as a successful archive, will appear on a blue background. Error messages such as a print or archive failure will appear on a red background. Page | 31

Multi-patient display sub-screen fields

Channel name

ID# (or name)

Protocol timers

USING THE SYSTEM Heart rate [min, max] VPB perminute

Lead name and gain

Alarm time

Alarm/event message

Print icon

Parameters

Figure 8 - Detail view of a sub-screen within the multi-patient display.

A right click on the print icon shows a sub menu:

 Rhythm

 12-lead

 ST-Report

 12-lead with Export

 Trends

 Summary Report

A left click on the print icon will generate a printout according to the user-defined default print setting

A red-crossed circle on the print icon indicates that alarm printouts have been disabled in the Alarm settings tab.

SpO2 display

When SpO2 data is available, the sub-screen may also be configured to display the plethysmogram and/or a SpO2 information block, as shown in the following example:

Plethysmogram waveform

Signal Quality Indicator

Figure 9 - Detail view of a sub-screen showing telemetry from a Surveyor S4 with SpO2. The plethysmogram is derived from the SpO2 sensor placed on the patient, via the transmitting device. Its pulsatile characteristic reflects the flow of blood at the measurement site, but it is not a representation of arterial pressure. The plethysmogram is normalized so that its amplitude is continuously and automatically adjusted to fill the available display space. Consequently, the plethysmogram cannot be used to assess the strength of the signal; however, it is useful to visualize the impact of noise on the SpO2 signal. Within the SpO2 parameter block, the following items are displayed:  functional oxygen saturation in units of % SpO2,  pulse rate in units of beats/minute, and  a Signal Quality Indicator (SQI) appearing as a colored square. Page | 32

USING THE SYSTEM

SpO2 Signal Quality Indicator (SQI) When used with a Surveyor S4, the SQI gives information about the condition of the signal being received by the sensor, as described in the table below. The S12/S19 and T12S do not support the SQI feature, and the SQI displays only a gray square.

SQI color

Description S4

S12/S19

T12S

 Green  Yellow

Good signal Signal is weak and/or degraded by noise such as motion artifact. Percent SpO2 and PR value displayed may potentially be inaccurate.

Not applicable.

Not applicable.

Feature not available. Feature not available.

 Red

The signal is missing or inadequate for SpO2 to be calculated.

 Gray The SpO2 is initializing.

No SQI information No SQI information

available.

available.

Refer to the Surveyor S4 User Manual, p/n 9515-190-51, for information on how to address signal quality issues. Additionally, technical alarm messages from the S4 may be displayed indicating certain conditions.

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USING THE SYSTEM Single-patient Display A left click anywhere on a patient's sub-screen changes the background color, reduces the multi-patient display to half width, and opens the selected patient-related information on the right half of the screen in the Traces view. Patient-related functions will be explained later in this manual. Click on Close to return to the multi-patient display screen. Selected telemetry patient sub-screen, Telemetry Traces view Figure 10 - The multi-patient display has been reduced to fit on the left screen, while a detail patient view from telemetry is shown on the right. Page | 34

S12/S19 patient traces view

USING THE SYSTEM

Figure 11 - The multi-patient display has been reduced to fit on the left screen, while a detail patient view from a Surveyor S12/S19 is shown on the right. Single-patient display tabs When a patient is selected and opened, there are six tabs that can be used for review. All tabs contain information for the selected patient. If another patient is selected, the information in the tabs will change to that of the selected patient. Patient ID (or name) and ambulatory transmitter channel number (if available) are displayed above the tabs. NOTE: The Patient Data tab is not available at the Surveyor Central repeater station. Figure 12 - Tab controls available in the single-patient display. Page | 35

USING THE SYSTEM Event/Alarm and Full-disclosure Review A right click anywhere on a patient's sub-screen or a left click on Review changes the background color, reduces the multi-patient display to half width, and opens the selected patient’s captured events/alarms and stored data on the right half of the screen. Review functions will be explained later in this manual. Click Close to return to the multipatient display screen. Figure 13 - Event/alarm and full-disclosure review screen. Page | 36

USING THE SYSTEM

Beginning a 12-lead ECG monitoring session

Correct electrode placement and skin preparation are important for acquiring a successful ECG and performing a reliable monitoring session. Low-amplitude signals may be the result of poor skin-to-electrode contact. To ensure electrode adherence, hair must be removed with a razor and the skin must be clean and dry. Gently abrade the skin where the gel will be in contact to ensure good ECG signal conduction. Avoid muscular and loose, flabby areas to minimize movement and muscular artifact. Good quality, long-term monitoring electrodes are recommended.

R RL V1 V2 V3 Figure 14 - Electrode placement.

AAMI IEC

Limb electrodes

LA

RA

R Right clavicle as shown

LA V4 RL V5

V6

LL

LL*

L Left clavicle as shown N Reference or ground lead, placed to maximize patient comfort F Lower left side of body, as close to hip as possible, on the iliac crest (original MasonLikar position) or lowest rib on the left side of chest (modified Mason-Likar position)

Precordial electrodes

LL*

V1

C1 Fourth intercostal space at the right sternal

border

V2

C2 Fourth intercostal space at the left sternal

border

V3

C3 Midway between V2 and V4

V4

C4 Fifth intercostal space at the left

midclavicular line

V5

C5 Anterior axillary line on the same horizontal

level as V4

V6

C6 Mid-axillary line on the same horizontal

level as V4 and V5

WARNING: Placement of the Left Leg (LL)* electrode in the original Mason-Likar position increases the similarity of the acquired ECG with a standard 12-lead ECG and is therefore recommended; however, clothing may interfere with this position and increase the amount of artifact. The modified position may decrease the sensitivity of inferior ECG leads and because axis shift with respect to the standard 12-lead ECG. Accurate skin preparation and suitable clothing are the most important factors in excessive artifact prevention. NOTE: The Right Leg (RL) electrode may be positioned in any location least subject to motion artifact according to clinician preference and specific test requirements.

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USING THE SYSTEM To begin a 12-lead monitoring session: 1. Prep patient skin and attach monitoring electrodes and ECG cable to patient. 2. Ensure the Surveyor Central station is powered ON and displays patient monitoring slots.  When a Surveyor S12/S19 patient monitor is used: o Power ON the patient monitor or resume monitoring from a Standbymode. o Ensure the Network icon on the S12/S19 main display shows communication to the Surveyor Central station. o Refer to the Surveyor S12/S19 patient monitor user manual (PN 9515-183-51-ENG).  When a Surveyor S4 is used: o Apply the sensors to the patient and connect sensor cables to the S4. Refer to the S4 user manual (PN 9515-190-51-ENG) for specific instructions. o Secure the S4 to the patient’s body with the carrying pouch. o Turn the S4 ON by inserting batteries. o Ensure that the S4 establishes a connection to the Surveyor Central. o Check signal quality indicators on the S4, and re-prep electrode sites or reposition sensors as needed. o On the multi-patient display of Surveyor Central, locate the slot that matches the S4 and view the waveforms. NOTE: If you do not have a window set for the ambulatory transmitter, refer to the “System Configuration” section to setup receiver channels. Configurations for Surveyor S12/S19 and Surveyor S4 will be in place based on factory settings. 3. Click on window and the single-patient display will open with Patient Data tab active. Choose desired patient profile using the drop-down list box. NOTE: Creating and saving patient profiles will be explained in the Settings section of this user manual. 4. Click Start to start a new monitoring session. From this moment on, monitoring has started, data is stored, and the alarm system is activated. The system will ask you to select the best ECG detection leads. If you click No the system will use default lead settings (V1, V5 and II). When Yes is selected, real-time, 12-lead ECG traces will be displayed allowing you to change detection leads if necessary. Select Learn to make any changes. Refer to the “Traces” section for more detail about the Learn button. After reviewing or changing the 12-lead display settings, click on the Patient Data tab to return to the window that allows you to enter patient demographics. NOTE: Refer to Appendix A to learn more about the importance of selecting the best detection leads. Page | 38

5. Click New and type the patient information in the text entry fields.

USING THE SYSTEM

Figure 15 - The patient data screen. NOTE: Age is calculated automatically when date of birth is entered (click on any other field to activate the calculation). Age can also be entered manually. 6. When finished with all patient data operations, click Confirm in the lower portion of the display. A warning will ask if you are sure. Click Yes. NOTE: Confirmation of the patient data connects the stored data with patient demographics, and makes the data available for review. ID Format When ID Format option is present on your system, you can select from a drop-down list of user-created IDs. ID Formats in the list were imported by use of the configuration menu using the Management selection. ID formats are created in conjunction with Welch Allyn’s E-Scribe system with the custom ID feature. Patient data fields can be populated through the use of a bar code scanner. After scanning the bar code to populate the field, select Confirm. If the patient demographics were previously entered, all available data fields will be automatically filled. Note that the patient ID must be unique in order for this mechanism to work correctly. If there are more patients with the same patient ID registered, the data of the first found will be copied to these data fields. Patient data can be retrieved from the previously populated patients list by clicking Import and choosing from the list. Page | 39

USING THE SYSTEM WARNING: For patients with pacemakers, the Pacemaker Present checkbox field should be enabled and the minimum rate of the pacemaker selected from the list. Figure 16 - Multi-patient display sub-screen for a pacemaker patient. PM indicates that pacemaker detection is enabled. The Notes field can be used to store information about the patient that will be available in the patient data display for other clinicians. Text in this field does not appear on printouts. WARNING: Adjust the alarm thresholds to patient conditions after monitoring has started. Incorrect alarm threshold settings are a frequent cause of false alarms and lower the attention level to the genuinely important alarms. NOTE: Alarm settings cannot be changed in a Surveyor Central repeater station and are presented for informational purposes only. NOTE: The Surveyor S12/S19 patient monitors control the alarm activation, sound state and priority of each generated alarm, regardless of the limits and/or other settings configured on Surveyor Central (even if conflicting with Surveyor Central settings). The Surveyor Central station obtains these settings from the patient monitor. Reduced Lead-set Monitoring: Ambulatory Transmitter When using an ambulatory transmitter, patients can be monitored using a reduced lead set either by not connecting all the electrode wires or using a reduced lead-set cable. When a reduced lead set is used, select the 5 electrodes cable radio button in the patient data display. NOTE: When the selection in the window above is changed, ECG waveforms are flat-lined for 1 second, heart rate is reset, and any pending ECG alarms are cleared. NOTE: If you change from 10 to 5 electrodes, it is recommended to select the best leads for QRS-detection (see Learn menu in the Traces tab). 5-wire Monitoring Using R (RA), L (LA), F (LL), N (RL) and C1 (V1) electrodes will enable you to monitor leads I, II, III, aVR, aVL, aVF and V1. Select the 5 electrodes radio button. The C1 (V1) electrode can be placed on any desired position on the thorax and will display and print as V1. NOTE: When using an ambulatory transmitter, reduced lead monitoring or the selection of the 5 electrodes radio button will cause unused leads on the ECG printouts to be substituted by square waves. NOTE: When using an ambulatory transmitter, reduced lead monitoring or the selection of the 5 electrodes radio button cannot be used when 12-lead ECG interpretation is required. Page | 40

USING THE SYSTEM 3-wire Monitoring Using R (RA), L (LA), and F (LL), electrodes will enable you to monitor leads I, II, or III using the S4 mobile monitor or S12/S19 patient monitor when using it with a 3-wire cable. NOTE: When using the S12/S19 patient monitor, the lead displayed on the Central Station is always indicated as Lead II regardless of the setting on the S12/S19 patient monitor. Depending on the lead selected, the ECG waveform available will be displayed on the various panels as shown below with Lead II as an example here.

Figure 17 - An example of 3-wire monitoring.

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USING THE SYSTEM Protocol Manager When Protocol Manager is included with your system, you are able to select from a list of user-created protocols. Protocols in the list were imported by use of the configuration menu using the Management selection. The protocols have been created from a separate application and are programmed to initiate automatic events and printouts once the protocol has been started. Select the protocol you wish to use for the current patient from the drop-down list located in the Patient Data tab. Protocols are saved with each individual profile and will be automatically selected by the profile. You can change to a different protocol at any time while monitoring a patient. Note that protocols are not available for use with the S12/S19 patient monitors. Using a Protocol A protocol will initiate automatic events, reminders, and printouts once it is started. A new protocol can be selected when there is no other protocol in progress. There are two ways to start the protocol: 1. After the monitoring session has started, select the Patient Data tab and then select Start Protocol to begin. 2. Change the date and time values to the right of the Start Protocol button as desired and thenselect Schedule start. The protocol will automatically start at the scheduled time. Once the protocol has been started, Protocol buttons will appear as shown:

Figure 18 - Protocol manager command buttons.

Stop Protocol can be selected to stop the protocol at any time. Once this is done, a “Protocol Aborted” message will appear on the patient display.

The date and time values can be set to correct the protocol phase start. The protocol phase that is currently in progress will be reset to a 00:00 start time and will begin at the set time. Select Correct phase start after you have adjusted the date and time values.

Additionally, “Protocol Times” can be selected for display (chosen in the “Settings” tab under “Parameters”). The time on the left shows that the protocol phase has progressed for 42 seconds and the next protocol step (Prepare for baseline) will occur in 18 seconds as shown to the right. Protocol messages will appear in the alarm/event area of the display according to protocol definitions. Protocols can be defined with

Figure 19 - Multi-display sub-screen with protocol active.

phases (or groups of steps) for automatic functions. The ambulatory transmitter calls button--when configured within the protocol--or acknowledgement of the last protocol step of the previous phase causes the next phase to begin. An example would be of sequential patient treatments requiring a new series or type of automatic events. The last step of any phase of a protocol is infinite in duration and will continue until you select Stop Protocol or move to the next phase by acknowledging the protocol alarm or pressing the ambulatory transmitter button.

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USING THE SYSTEM Ending a Monitoring Session: Telemetry 1. On the multi-patient display, click on desired patient window. 2. Select Patient Data tab. 3. Click on the Stop button. 4. A warning will ask if you are sure. Click Yes. NOTE: If the monitoring slot has not been assigned to any patient, recorded data will be deleted!! 5. This patient data will appear in the Patients list with a “Stopped” monitoring status. Restarting a Monitoring Session: Telemetry 1. On the multi-patient display, click desired patient window and the patient data window will open with patient data grayed out. Select Same Patient to resume monitoring the same patient in the same monitoring window. 2. Selection of New Patient will remove the previous patient monitoring session from the patient slot allowing you to start monitoring a new patient. The previous patient’s monitoring session will be available for review and will be shown in the patients listing with a “Stopped” status. 3. Previous stopped patient monitoring sessions can be imported into any available monitoring window when starting a new monitoring session. This allows you to move the patient to a different ambulatory transmitter and display window as desired. This also allows you to combine multiple monitoring sessions for the same patient. NOTE: You can also start and stop monitoring sessions directly from the Surveyor S4 user interface. Discharge: Surveyor S12/S19 Patient Monitor The Discharge function at the Surveyor S12/S19 patient monitor is communicated to the Surveyor Central station. When the patient is discharged at the patient monitor, the monitoring slot at the Surveyor Central station closes and all patient information, trends, alarms, and other setting information are being cleared for that device. Standby: Surveyor S12/S19 Patient Monitor The Surveyor S12/S19 patient monitor has a Standby mode used to temporarily suspend patient monitoring (patient returning to same monitor) or permanently discharge the patient (patient not returning to monitor). This function is performed while standing at the patient’s bedside monitor. When the S12/S19 is placed in the Standby mode, the Surveyor Central station will discontinue monitoring. The Surveyor Central station displays a Standby message in that patient’s monitoring slot to note that monitoring is not active for that patient device. Once the patient monitor resumes monitoring, the Surveyor Central station will resume monitoring. Resume Monitoring: Surveyor S12/S19 Patient Monitor Once the Surveyor S12/S19 resumes monitoring after a Discharge or Standby mode, the Surveyor Central station will also resume monitoring. Page | 43

8. SETTINGS The Settings tab allows you to define:  ECG and other waveform traces, gain settings, and parameters for single and multi-patient displays  12 lead ECG, rhythm, trend, and report printouts  ID or name highlight color  Signal settings  Number of ECG leads, ECG filtering, and amplitude for optimal beat detection  Protocol to be used for current patient  Profiles to be saved for future use Once all the settings under this tab, Alarm Settings, and Trends are defined, save your preferences as a Profile with a unique name that can be selected when starting future patient monitoring sessions. NOTE: HR (heart rate) is always selected and cannot be deselected under Parameters. NOTE: Some features (e.g., Protocols and Plethysmogram) are optional and may not be available as selections in this window. NOTE: Print settings, Signals and Protocol settings cannot be changed in a repeater station and are presented for informational purposes only. Profiles cannot be saved from a repeater station. Page | 44

SETTINGS Display settings Multi-patient View multi-patient display selections on the previous page. Selections will appear grayed when the maximum number of choices is reached, and is dependent on display window height. Trace and parameter selections for single-patient display are shown below. Figure 20 - Trace and parameter selection screen. Traces ECG and plethysmogram waveform tracings can be selected for both multi-patient and traces (single patient) display. Selection of at least one trace is required. Parameters Parameter labels and values can be selected for both multi-patient and traces (single patient) display. Parameters are displayed in the order that they appear in the Parameters column. Page | 45

SETTINGS ID In multi-patient display, select the color highlighting for the ID or patient name from the drop-down list to the right of ID: The configuration menu determines which value (ID or name) will be shown in the multi-patient display. ECG Filter In multi-patient display, choose a 0.05 – 40 Hz ECG filter or a 0.05 – 150 Hz ECG filter from a drop-down list after clicking on the value to the right of this selection. Filter setting has no effect on stored and exported data analyses. WARNING: 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. ECG Gain (mm/mV) In multi-patient display, select 5 mV, 10 mV, 20 mV, or 40 mV of gain for all ECG traces from a drop-down list after clicking on the value to the right of this selection. This setting affects displayed traces as well as rhythm printouts. Plethysmogram Gain In multi-patient display, select 0.5 to decrease sensitivity by one half, 1 for normal sensitivity, or 2 to maximize the sensitivity for plethysmogram traces from a drop-down list after clicking on the value to the right of this selection. This setting affects displayed pleth traces as well as rhythm printouts. Invasive Pressure Waveform Gain The Surveyor Central Station can display up to four invasive pressure waveforms and numerics dependent upon the S12/S19 configuration. To adjust the invasive pressure waveform, gain, in the multi-patient display select 0.1, 0.25, 0.5, 1, or 2 mm/mmHg for the selected invasive pressure. Capnography Waveform Gain To adjust the Capnography waveform gain in the multi-patient display, select 0.1, 0.25, 0.5, 1, or 2 mm/mmHg Print settings Allows you to define and customize each type of printout as explained below. Click on type of printout you want to define under the PRINT selection. Printout examples are shown in Appendix C. NOTE: Print settings cannot be modified on a Surveyor Repeater station. Rhythm Checked boxes under Traces define waveform to be included on a 10-second printout. Desired parameter labels and values can be checked under Parameters. Change rhythm printout speed by clicking on the value to the right of Speed (mm/s). A drop-down list allows you to choose 5, 10, 25, or 50 mm/s paper speed. Click on checkbox area to the right of Print Grid selection to enable or disable grid. Note that the grid is not printed at 5 mm/s or when grid is disabled for the printer in the configuration menu. The Surveyor S12/S19 patient monitors can be configured to print its rhythm strip to the central station’s printer. Refer to the Surveyor S12/S19 patient monitor user manual (PN 9515-183-51-ENG) for additional details. Page | 46

SETTINGS Rhythm traces are printed with the timestamp centered in the middle of the page, as shown the by a vertical dotted line. 12-leads 12-lead printout format is selected from the drop-down list to the right of Format. Choose from 6x2 (6 leads in 2 columns), 4x3+1 (3 leads in 4 columns with 1 rhythm channel [II]), 4x3+3 (3 leads in 4 columns with 3 channels of rhythm [II, V1 and V5]), or 4x3+1+P (3 leads in 4 columns with 1 rhythm channel [II] and plethysmogram waveform). Rhythm channels cannot be changed. Click on Print Grid checkbox to enable or disable grid. 1 to 4 copies can be selected when each 12-lead printout is chosen. Click on Print Interpretation and Print Reasons checkboxes to enable or disable interpretive statements on the 12-lead printouts. 12-lead ECG’s are printed with the timestamp corresponding to the beginning of the acquisition of the ECG. The Surveyor S12/S19 patient monitors will print its 12-lead report to the central station’s printer. Refer to the Surveyor S12/S19 patient monitor user manual (PN 9515-183-51-ENG) for additional details. ST Report Use the drop-down list to select trends to be printed on the report printout. The second trend in the rate-trend panel can be selected (the first trend is always HR), and both trends in the right panel can be selected from other parameters. Trend length (number of hours) can be defined in the Trends tab. The Surveyor S12/S19 patient monitors can be configured to print a Trend report that includes the ST numerics to the central station’s printer. Refer to the Surveyor S12/S19 patient monitor user manual (PN 9515-183-51-ENG) for additional details. Trend Allows you to choose a single or two-page printout. The ST Page contains labels and trend values related to ST measurements in all leads; Second Page includes labels and trended values for all checked information in the lower portion of the display. Up to 14 trends can be selected. The Surveyor S12/S19 patient monitors can be configured to print a Trend report to the central station’s printer. Refer to the Surveyor S12/S19 patient monitor user manual (PN 9515-183-51-ENG) for additional details. Summary report The Summary report provides a configurable report to tailor information to each specific patient’s needs. The report includes the following information:  Patient demographics  Patient overview information, which includes average and summary information of parameters.  List of alarms.  Graphical parameter trends (optional).  Tabular parameter trends (optional).  Alarm snapshots (optional) – shows one tracing of an alarm condition; also shows a timeline of alarm occurrences. Page | 47

SETTINGS Figure 21 - Summary Report settings. To configure the content of the summary report: 1. Select the patient by clicking on their slot in the Multi-Patient display. 2. Select the Settings tab. 3. Select the Summary Report page. 4. Select the Report Duration from the drop down list. The system supports reports covering 4, 8, 12, and 24 hours. 5. Select the reporting interval for tabular trends from the Tabular Trends Interval dropdown. The System supports intervals of 1, 5, 15, 30, and 60 minutes. 6. Select whether or not to include graphical trends in the report using the Graphic Trendscheckbox. 7. Select whether or not to include tabular trends in the report using the Tabular Trendscheckbox. 8. Select whether or not to include alarm snapshots in the report using the Alarm Snapshots checkbox. 9. Select the parameters to include in trends from the selections in the Trends box. 10. Based on your selections, the system estimates the length of the printed report in the Report PagesNum. indicator. 11. Select the Confirm button. To print a summary report… 1. Right-click on the Print Icon in the Multi-Patient display. 2. Select Summary Report from the drop down menu. Page | 48