Surveyor S12 and S19 User Manual Rev E V3.1.0 Oct 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. Software V3.1.0 Welch Allyn is a registered trademark of Welch Allyn, Inc. Surveyor™, AM12M™, and VERITAS™ are trademarks of Welch Allyn, Inc. Nellcor™, Covidien™, C-LOCK™, Sat Seconds™, OxiMax™, MAX™, Max-Fast™, Soft Care™, Oxiband™, Dura-Y™, Pedi Check™, OxiCliq™, and Durasensor™ are trademarks of Nellcor Puritan Bennett Inc. Smart Capnography™, Smart Breath Detection Algorithm™ (BDA™), Smart Alarm Respiratory Analysis ™ (SARA), Integrated Pulmonary Index™ (IPI), Micro stream®, Filter line® and Capnoline® are trademarks or registered trademarks of Oridion Medical Ltd. Edwards® is a registered trademark of Edwards Lifesciences Corporation. Oridion CO2 License Information NO IMPLIED LICENSE Possession or purchase of this bedside monitor does not convey any express or implied license to use the bedside monitor with unauthorized consumable CO2 sampling products which would, alone, or in combination with this bedside monitor, fall within the scope of one or more patents relating to this bedside monitor and/or CO2 sampling consumable products. The capnography component of this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending. All other trademarks and registered trademarks are the property of their respective owners. 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]

9515-183-51-ENG Rev E Revision Date 2019-10

901138 PATIENT MONITOR

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

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

TABLE OF CONTENTS 1.

NOTICES ... 6 MANUFACTURER’S RESPONSIBILITY ...6 RESPONSIBILITY OF THE CUSTOMER ...6 EQUIPMENT IDENTIFICATION ...6 COPYRIGHT AND TRADEMARK NOTICES ...6 OTHER IMPORTANT INFORMATION...6 NOTICE TO EU USERS AND/OR PATIENTS: ...7

2.

WARRANTY INFORMATION ... 8 YOUR WELCH ALLYN WARRANTY...8

3.

USER SAFETY INFORMATION ... 10 SAFETY REGULATIONS...10 CAUTIONS ...22 NOTES ...23

4.

EQUIPMENT SYMBOLS AND MARKINGS ... 25 SYMBOL DELINEATION ...25 NETWORK SYMBOL DELINEATION ...26

5.

GENERAL CARE ... 27 PRECAUTIONS ...27 INSPECTION ...27 CLEANING ...27 MAINTENANCE ...30 BATTERY REPLACEMENT ...33

6.

ELECTROMAGNETIC COMPATIBILITY (EMC) ... 37 REGULATORY RADIO COMPLIANCE ...41 EUROPEAN UNION ...43

7.

INTRODUCTION ... 44 GENERAL INFORMATION ...44 INDICATIONS FOR USE ...44 CONTRAINDICATIONS...44 SYSTEM OVERVIEW ...45

8.

INSTALLATION AND SETUP ... 48 UNPACKING AND CHECKING...48 INSTALLATION METHODS ...48 POWER ON/OFF ...49 TO CONNECT FOR CENTRAL STATION COMMUNICATION...50 TO CONNECT FOR 3RD PARTY EMR SOFTWARE ...50

9.

MAIN SCREEN DISPLAY ... 52 OVERVIEW ...52 PARAMETER AREAS ...52 QUICK-ACTION KEY AREA ...54 MESSAGE AREA...56 DEMOGRAPHIC AND STATUS AREA ...57

1

TABLE OF CONTENTS

10.

PATIENT MANAGEMENT ... 58

OVERVIEW ...58 PATIENT INFORMATION DIALOGUE ...58 ADMIT ...60 STANDBY MODE ...60 11.

REMOTE VIEW AND ALARM NOTIFICATION ... 63

REMOTE VIEW - OVERVIEW ...63 REMOTE VIEW CONFIGURATION AND DISPLAY...64 NETWORK SETUP ...64 SETTING REMOTE VIEW OPTIONS ON THE S12/S19 MONITOR ...65 USING REMOTE VIEW...66 REMOTE VIEW ALARM NOTIFICATIONS ...66 THE REMOTE VIEW NOTIFICATION INDICATOR...67 12.1.1. OBSERVING AN ALARM NOTIFICATION USING REMOTE VIEW ...68 REMOTE VIEW WITHOUT PRESENCE OF AN ALARM NOTIFICATION ...69 SILENCED REMOTE ALARMS ...70 REMOTE VIEW AND ALARM NOTIFICATION TROUBLESHOOTING ...71 12.

ALARM BEHAVIORS AND MANAGEMENT ... 72

GENERAL ALARM BEHAVIOR ...72 PHYSIOLOGICAL ALARMS ...72 TECHNICAL ALARMS ...72 INFORMATIONAL ALERT MESSAGES ...72 ALARM NOTIFICATIONS...73 ALARM LATCHING ...76 ALARM DELAY...77 MULTIPLE ACTIVE ALARMS: HIERARCHY OF DISPLAY ...77 AUTOMATIC PRINT ON ALARM ...77 ADJUSTING ALARM LIMITS...78 ADJUSTING ALARM LEVELS ...79 ALARM AUTO SET ...80 ALARM INTERFACES...81 13.

ECG MONITORING ... 82

OVERVIEW ...82 QUALITY ECG DATA ACQUISITION ...82 ELECTRODE LOCATIONS...84 CHECKING THE ECG SIGNAL...89 ECG WAVEFORM TILE ...90 ALL ECG/12-LEAD DISPLAY MODE ...90 RESTING 12-LEAD ECG INTERPRETATION ...91 14.

ECG/HEART RATE/PULSE RATE MONITORING ... 93

OVERVIEW ...93 HEART RATE/PULSE RATE TILE ...93 HR/PR ALARM BEHAVIORS ...93 HEART RATE/PULSE RATE SOURCING ...93 SETUP HR/PR DIALOGUE ...94 15.

ECG ARRHYTHMIA MONITORING ... 99

2

TABLE OF CONTENTS

OVERVIEW ...99 NOISE AND ARTIFACT ...99 ABERRANT BEATS ...100 ATRIAL RHYTHMS ...100 ARRHYTHMIA/ST ALGORITHM LEARNING ...100 ARRHYTHMIA ANALYSIS METHODOLOGY ...101 ARRHYTHMIA DEFINITIONS ...103 ARRHYTHMIA SETUP...105 ARRHYTHMIA SETTINGS ...106 16.

ECG ST MONITORING ... 107

OVERVIEW ...107 ENABLE/DISABLE ST ANALYSIS ...108 ST TILE ...108 ST ALARM BEHAVIORS ...108 ST TILE ALARM BEHAVIORS ...109 ST ALARM DELAY ...109 17.

NON-INVASIVE BLOOD PRESSURE MONITORING... 114

OVERVIEW ...114 BLOOD PRESSURE TECHNOLOGY ...115 NEONATE & PEDIATRIC PATIENT NIBP CONSIDERATIONS ...115 HYPERTENSIVE PATIENT CONSIDERATIONS ...115 NIBP MONITORING PROCEDURE ...116 NIBP TILE ...116 NIBP ALARM BEHAVIORS ...117 NIBP START/STOP QUICK-ACTION KEY ...117 SETUP NIBP DIALOGUE ...117 CUFF OVERPRESSURE ...121 18.

SPO2 MONITORING ... 122

OVERVIEW ...122 SPO2 MONITORING PROCEDURE ...122 SPO2 DISPLAY ...123 SPO2 ALARM BEHAVIORS ...123 SETUP SPO2 DIALOGUE ...124 SPO2 FUNCTIONAL TESTING...126 19.

TEMPERATURE MONITORING... 127

OVERVIEW ...127 TEMPERATURE MONITORING PROCEDURE ...127 TEMPERATURE DISPLAY ...127 TEMPERATURE ALARM BEHAVIORS ...127 SETUP TEMPERATURE DIALOGUE ...127 20.

RESPIRATION MONITORING ... 130

OVERVIEW ...130 RESPIRATION ACQUISITION ...130 RESPIRATION ALARM BEHAVIORS...130 RESPIRATION DISPLAY...131 SETUP RESPIRATION (RR) DIALOGUE ...131

3

TABLE OF CONTENTS

21.

CO2 MONITORING ... 134

OVERVIEW ...134 PRINCIPLES OF OPERATION ...134 INTEGRATED PULMONARY INDEX (IPI) PARAMETER ...135 CO2 MONITORING PROCEDURE...136 CO2 DISPLAY ...136 CO2 ALARM BEHAVIORS ...137 SETUP CO2 DIALOGUE ...137 22.

INVASIVE PRESSURE MONITORING ... 141

OVERVIEW ...141 INVASIVE PRESSURE MONITORING PROCEDURE ...141 INVASIVE PRESSURE DISPLAY ...142 INVASIVE PRESSURE ALARM BEHAVIORS ...143 SETUP INVASIVE PRESSURE DIALOGUE ...143 MEASURING PAWP...147 OVERLAPPING INVASIVE PRESSURES ...150 23.

THERMODILUTION CARDIAC OUTPUT ... 151

OVERVIEW ...151 CO DISPLAY ...151 CO ALARM BEHAVIORS...152 SETUP CO DIALOGUE ...152 24.

HEMODYNAMIC CALCULATIONS ... 158

OVERVIEW ...158 HEMODYNAMIC CALCULATION PARAMETERS ...158 HEMODYNAMIC CALCULATION DIALOGUE ...158 25.

LIST TRENDS ... 161

OVERVIEW ...161 TRENDS DIALOGUE...161 26.

SETUP ... 164

OVERVIEW ...164 PATIENT INFORMATION...164 PARAMETERS ...164 WAVEFORMS ...165 RECORDER...167 ARRHYTHMIA ...168 ALARM SUSPEND ...169 ALARMS...170 AUDIO ...171 RESTORE DEPARTMENTAL DEFAULTS ...172 ADMINISTRATION ...172 27.

PRODUCT SPECIFICATIONS ... 178

GENERAL SPECIFICATIONS ...178 ENVIRONMENTAL CONDITIONS ...178 POWER REQUIREMENTS & BATTERY ...179 DISPLAY SPECIFICATIONS ...179

4

TABLE OF CONTENTS

RECORDER SPECIFICATIONS...180 MOUNTING SPECIFICATIONS ...180 TRENDING ...180 28.

PARAMETER SPECIFICATIONS ... 181

PATIENT POPULATIONS ...181 WAVEFORMS ...181 ECG ...182 ARRHYTHMIA ANALYSIS ...183 ST ANALYSIS ...183 NON-INVASIVE BLOOD PRESSURE (NIBP) ...184 PULSE OXIMETRY (SPO2) ...185 TEMPERATURE ...185 RESPIRATIONS: VIA ECG IMPEDANCE...186 CAPNOGRAPHY (CO2) ...186 INVASIVE PRESSURES ...187 CARDIAC OUTPUT ...188 29.

PARAMETER ALARM LIMIT RANGES ... 189

ADULT PATIENT MODE ...189 NEONATE PATIENT MODE ...190 PEDIATRIC PATIENT MODE ...192 30.

ALARM SPECIFICATIONS ... 194

GENERAL ALARMS ...194 ECG AND HR MESSAGES ...194 NON-INVASIVE BLOOD PRESSURE (NIBP) MESSAGES ...196 PULSE OXIMETRY (SPO2) MESSAGES ...197 TEMPERATURE MESSAGES ...198 RESPIRATION MESSAGES ...199 CAPNOGRAPHY (CO2) MESSAGES ...200 INVASIVE PRESSURE MESSAGES ...201 CARDIAC OUTPUT MESSAGES ...202 NETWORK MESSAGES...203 31.

TROUBLESHOOTING ... 204

POWER AND BATTERY...204 DISPLAY AND TOUCH SCREEN ...204 ECG, ARRHYTHMIA, AND ST...205 NON-INVASIVE BLOOD PRESSURE (NIBP) ...206 PULSE OXIMETRY (SPO2) ...206 TEMPERATURE ...207 RESPIRATIONS: VIA ECG THORACIC IMPEDANCE ...207 CAPNOGRAPHY (CO2) ...207 INVASIVE PRESSURES ...208 CARDIAC OUTPUT ...208 32.

ACCESSORIES ... 209

33.

APPLIED STANDARDS ... 215

5

1. NOTICES Manufacturer’s Responsibility Welch Allyn, Inc. is responsible for the effects on safety and performance of the patient monitor, as indicated by the label, only if article 2 of 93/42/EEC directive is applied, in particular: WARNING: System installation and assembly operations, extensions, readjustments, modifications or repairs are carried out by personnel authorized by Welch Allyn, Inc. only. The patient monitor is used in accordance with the instructions for use. The patient monitor is correctly maintained according to the standards authorized by Welch Allyn, Inc. using original spare parts. The patient monitor is used with original accessories and supplies that are in compliance with the standard specifications described in this manual. The electrical installation of the relevant room complies with the requirements of appropriate regulations.

Responsibility of the Customer The user of this patient monitor 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 patient monitor must periodically check the accessories, their functionality and integrity.

Equipment Identification Welch Allyn, Inc. equipment is identified by a serial and reference number on the back of the patient monitor. 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.

6

NOTICES

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.

7

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) Supplies, accessories and internal parts NOT approved by Welch Allyn; c)

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

d) Accident; e)

A disaster affecting the Product/s;

f)

Alterations and/or modifications to the Product/s not authorized by Welch Allyn;

g) 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 there from 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.

8

WARRANTY INFORMATION

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.

9

3. USER SAFETY INFORMATION WARNING:

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

Caution:

Means there is the possibility of damage to the patient monitor.

Note:

Provides information to further assist in the use of the patient monitor.

NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures 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.

Safety Regulations 

Surveyor is a medical patient monitor.



Surveyor with all accessories that have a physical or logical connection with it, forms part of a Medical Electrical System. Surveyor complies with various safety and performance regulations as mentioned in this manual (Applied Standards).

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

Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this patient monitor. Patient monitor 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.



Before attempting to use this device 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 patient monitor. Contact Welch Allyn Technical Service for additional training options.



The patient monitor provides the possibility to monitor multiple functions, but is not intended to be connected to more than one patient.



Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human subjects, may cause inaccurate results.



A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. Do not mount any part of the device closer than 25 cm from outlets of flammable gases, including oxygen.

10

USER SAFETY INFORMATION



For proper operation and the safety of users or patients and bystanders, equipment and accessories must be connected only as described in this manual.



Repairs and modification must be made by authorized and trained technical personnel. Unauthorized modifications and repairs will void the Surveyor warranty and may pose a danger to patients and users.



The Surveyor, 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.



The quality of the signal produced by the device may be adversely affected by the use of other medical equipment, including but not limited to electrosurgery and ultrasound machines. Do not use the system in the presence of imaging equipment such as magnetic resonance imaging (MRI) and tomography systems. Simultaneous operation may damage the device or lead to erroneous results.



Portable and mobile RF communications equipment may affect medical electrical equipment or systems as well as the Surveyor and its accessories. Do not operate the Surveyor near high frequency emissions (e.g. microwaves).



Various alarm conditions require operator to adjust alarm configurations individualized according to patient condition and demographics. Surveyor supports the selection of appropriate alarm profiles when a patient is admitted. The operator should check these settings with each patient admission to ensure the alarm settings are appropriate for the individual patient. Inappropriate alarm configuration settings may render the alarm system useless.



Surveyor 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 level, 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. Always respond promptly to alarms.



A patient monitor is an addition to monitoring patient status and is not intended to replace clinical assessments and clinical judgments. It is important that a qualified individual regularly supervise the patient.



In an environment where multiple systems, whether Surveyor and/or other systems, are utilized for monitoring patients, use of different alarm presets on each system may pose a safety risk. Be careful in using different alarm conditions on different systems.



Always ensure that the Patient Mode (adult, pediatric, neonate) is set appropriately for the patient since different default parameters of the monitor’s operation may be used depending on mode.

Power Warnings 

Only use the Welch Allyn-provided external power adapter with the Surveyor. Ensure that the power adapter is connected to a properly grounded power terminal and the electrical installation complies with local safety requirements for the environment where it is used.



To ensure that electrical safety is maintained during operation from AC power, the Surveyor external power adapter must be plugged into a hospital-grade outlet.



Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated from its internal battery power source.



Do not use the Surveyor power supply to power other devices, because of the risk of additional leakage currents and of transformer overload.

11

USER SAFETY INFORMATION



The device is not operative if no image appears on the screen. If the device becomes inoperative during monitoring, a medium level type alarm sounds and the system resets automatically.



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



The Surveyor contains a lithium ion battery. The following precautions should be taken regarding the battery: o

Do not immerse the device in water.

o

Do not heat or throw the device in fire.

o

Do not leave the in conditions over 60 ºC or in a heated car.

o

Do not crush, drop, or puncture the battery as this may result in overheating and possible fire.

o

Only use the approved Welch Allyn battery pack with the Surveyor monitor.

o

Follow the instructions in the disposal section of this manual when the Surveyor monitor is taken out of service.



The Surveyor battery must be initially fully charged prior to use. Ideally, the battery must be fully charged and fully discharged several times to allow for optimal performance.



The Surveyor produces audible startup tones when powered on (two tones followed by two higher beeps). If a patient monitor does not sound the startup tones when it is powered on, remove the patient monitor from service and contact Welch Allyn Technical Support.



If the AC power supply is interrupted or disconnected during monitoring, the Surveyor switches to battery backup if the battery is properly installed and has sufficient charge. If power is completely interrupted, including exhausting the battery supply, monitoring will cease until AC power supply has been restored or a fresh battery is installed, and the monitor’s power switch is recycled.



For continued operation, always connect the Surveyor to a wall outlet when a Low Battery alarm indication occurs. Failure to do this can lead to an interruption of monitoring.



Ensure the battery has sufficient charge prior to disconnecting the external power supply. To disconnect from the AC power, disconnect the external power adapter from AC power first, then disconnect the power connection from the back of the monitor.



Always reconnect the power cord to AC power after operating the patient monitor using battery power. This ensures that the batteries are recharged for the next time the patient monitor is operated on battery power. A light next to the on/off switch will illuminate indicating that the patient monitor is connected to mains power and charging. The battery icon on the main display indicates when the battery is fully charged.

Accessories, Cables, and External Connections Warnings 

The patient monitor is designed to meet applicable specifications when using Welch Allyn-approved patient cables and accessories. Use of non-approved cables and accessories may result in reduced performance and may pose possible patient and user safety concerns.

12

USER SAFETY INFORMATION



It is the user’s responsibility to use only approved supplies, accessories and internal parts available through Welch Allyn, Inc. Product performance and patient safety require the use of supplies, accessories and internal parts that comply with applicable standards. To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact must be in compliance with applicable standards including IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the patient monitor. Additionally, cables and accessories must comply with all EMC regulations. In Europe, cables and accessories should bear the CE Mark. Only use parts and accessories supplied with the patient monitor and available through Welch Allyn, Inc.



Medical devices have been designed to have a higher degree of protection against electric shock than, for instance, information technology equipment because patients often are connected to multiple devices and also may be more prone to the adverse effect of electric currents than healthy persons. All equipment that is connected to the patient, can be touched by the patient, or can be touched by another person while that person touches the patient at the same time, should have the same level of protection against electric shock as medical equipment. The Surveyor patient monitor is a medical device that has been designed to be connected to other devices for the purpose of receiving and transmitting data. Certain measures must be taken to prevent the risk of excessive electric current flow through the operator or patient when connected: o

All electrical equipment that is not medical electrical equipment must be placed outside of the “patient environment,” defined by applicable safety standards to be at least 1.5 meters (5 feet) from the patient. Alternatively, non-medical equipment may be provided with additional protection such as an additional protective earth connection.

o

All medical electrical equipment that has a physical connection to the Surveyor or the patient, or is in the patient environment must comply with applicable safety standards for medical electrical devices.

o

All electrical equipment that is not medical electrical equipment and has a physical connection to the Surveyor must comply with applicable safety standards, such as IEC 60950 for information technology equipment. This includes information network equipment connected through the LAN connector.

o

Conductive (metal) parts that can be touched by the operator in normal use and that are connected to nonmedical equipment should not be brought into the patient environment. Examples are connectors for shielded Ethernet or USB cables.

o

If multiple devices are connected to each other or to the patient, device chassis and patient leakage currents may be increased, and should be measured for compliance with applicable standards for medical electrical systems.

o

Avoid the use of portable multiple socket outlets. If used and not compliant with medical electrical device standards, an additional protective earth connection is required.

o

To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment, network cable shielding (where used) must be connected to protective earth ground appropriate to the area where the device is used.



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



Proper clinical procedure must be employed to prep the electrode and sensor sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions. Electrodes and other sensors are intended for short-term use and should be removed from the patient promptly following testing.



Conductive parts of the ECG patient cables, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground.

13

USER SAFETY INFORMATION



To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with patient monitor or patient cables. Additionally, proper placement of defibrillator paddles in relation to the ECG electrodes is required to minimize harm to the patient.



To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes, IBP catheters, disposable SpO2 sensors, disposable temperature sensors, single-use blood pressure cuffs, etc.) must not be reused. Welch Allyn-approved manufacturers of accessories provide separate user manuals (e.g., patient cables, electrodes, etc.). Read these manuals thoroughly and refer to them for specific functions. It is recommended to keep all manuals together.



To maintain safety and effectiveness, reusable sensors and cables - such as ECG electrodes and SpO2 sensors must not be used beyond their expiration date or useful life.



All accessories including hoses, cables, connectors, hoses and other patient-applied parts supplied with the Surveyor do NOT contain any Latex. If the patient develops an allergic reaction or rashes, immediately remove the accessory and inform Welch Allyn Technical Support.



Check the date and integrity of the packing of all accessories that need to be sterilized before use.



Do not attach unauthorized devices such as a mouse or keyboard to the USB port.



Do not attach unauthorized patient cable for use with AM12M. Patient cable should provide locking mechanism to mating device.

Use with Electro Surgery Devices Warnings 

The Surveyor is approved for use in the presence of electrosurgical (ESU) equipment providing the following precautions are taken: o

To minimize the risk of patient burns, only use ESU equipment that monitors the impedance of the ESU return wires.

o

Users should be properly trained in the operation of the ESU equipment.

o

The AM12M 12-Lead ECG Acquisition Module should NOT be used when operating ESU equipment.

o

Keep patient-applied cables (e.g., ECG lead wires) off of earth ground and away from the ESU knife and return wires to prevent burns to measurement sites.

o

To prevent burns to the patient in the event of a defective neutral ECG electrode of the device, it is necessary to place ECG electrodes far from the neutral electrode, and as equidistant as possible from the blade-neutral axis of the surgical patient monitor.

o

When activating the ESU device, the ECG signals may be distorted or may disappear, and Lead Fail or Noise alarms might be present. The signal should return once the ESU activation stops.

o

When activating the ESU device, using the SpO2 parameter as the heart rate source rather than the ECG parameter to determine heart rate may be clinically preferred.

14

USER SAFETY INFORMATION

Installation and Mounting Warnings 

Place the Surveyor on a flat and leveled surface or mount it according to the manufacturer’s instructions. Use only mounting accessories indicated in this manual. Place the Surveyor in a well-ventilated place. Keep the Surveyor away from overly hot, cold or humid places, places directly under sunlight, or dusty surroundings.



Ensure that the Surveyor is securely placed or mounted such that it does not tip or drop which may damage the monitor and/or create a hazard to patients and hospital personnel.



Use only roll stands and wall-mount fixtures recommended for Surveyor in this manual. Other types have not been tested with the monitors and may not provide adequate safety against fall / tip-over.



A VESA-standard adapter is available on the back of the Surveyor system for wall, swivel-arm or rolling-stand mounting. The user is responsible for correct installation of the system.



Do not mount the S12 on a rolling stand at a height exceeding 110 cm (43”).



The S19 should NOT be mounted on a rolling stand.

ECG Warnings 

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 patient monitor.

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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 blank. A lead fail alarm is generated on the patient monitor.

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The AM12M acquisition module automatically calibrates when it is connected to the monitor or when the monitor powers up. If there is a very high amount of electrical interference present at that time (usually because electrodes make spurious contact with earth ground), the calibration may fail. The monitor is aware of the failure and will not display the ECG waveforms. If this happens, the user should attempt to recalibrate by reconnecting the AM12M to the monitor, making sure that there are no spurious contacts between electrodes and earth ground.

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ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.

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Defibrillation protection is guaranteed when the original Welch Allyn ECG patient cables are used.

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Use only ECG patient cables listed in Section ACCESSORIES with this monitor. Other cables have not be tested with the monitor and may not provide sufficient performance and/or defibrillation protection.

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Check ECG cables for cracks or breakage prior to use to ensure adequate defibrillation protection.

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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 equipped with Welch Allyn’s VERITAS™ 12-lead resting ECG interpretation algorithm. The VERITAS ECG algorithm can provide an over-reading physician with a silent second opinion through diagnostic statements output on the ECG report.

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USER SAFETY INFORMATION

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12-lead ECGs acquired through Surveyor 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 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.

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

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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.

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For full diagnostic quality, the resting ECG should be printed on the Surveyor Central Station printer and not on the S12 or S19 strip chart recorder.

ECG Calculated Heart Rate Warnings 

Heart rate indication is usually not affected by pacemakers with direct cardiac application, ventricular or supraventricular arrhythmias or irregular heart rates; however, in some conditions a pacemaker pulse can give rise to double QRS detections. Also, not activating the “Analyze Pacers” field in the signals menu in the presence of a pacemaker might lead to beat detections without a QRS complex due to the detection of the pacemaker spike.

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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.

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Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor rejects tall TWaves less than or equal to 230% of a 1 mV QRS in diagnostic mode, and 70% of a 1 mV QRS in monitoring mode, as well as a Q-T interval of 350 ms measured for both diagnostic and monitoring modes according to IEC 60601-2-27.

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The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in IEC 606012-27 Figure 201.101 patterns A1-A4 if the QRS amplitudes exceed the minimum detection threshold set by the user.

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Time to tachycardia alarm, as measured according to IEC 60601-2-27 Figure 201.101 patterns B1-B2 is less than 9 seconds.

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

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USER SAFETY INFORMATION

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

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

Welch Allyn 99.92 99.87 95.17 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 99.79 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.

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USER SAFETY INFORMATION

Warnings for Patients with Pacemakers 

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

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When using the 3/5 lead ECG cable, pacemaker spikes are normally recognized and rejected by the software. Signals are recognized as pacemaker spikes when they have a slew rate over 1.4 V/s, as measured according to IEC 60601-2-27.

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When using the AM12M 12-lead ECG Acquisition Module, pacemaker spikes in the range of 0.3 to 1.3 ms, ±2 to ±700 mV are recognized and rejected according to IEC 60601-2-27:2011.

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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 arrest.

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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.

Respiration Warnings 

When using an ECG electrode to calculate respiration rate via the thorax impedance method, movement artifacts may create inaccurate results. Respiration rates derived from CO 2 parameter is not subject to such movement artifacts.

SpO2 Warnings 

Use only approved pulse oximetry sensors specifically intended for use with the patient monitor. Unapproved components can result in degraded performance and/or device malfunction.

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Use pulse oximetry sensors specified for the correct patient mode and for the correct application position.

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Pulse oximetry sensors must be checked a minimum of every 4 hours and moved to a new site as necessary. Reposition the sensor at least once every 24 hours to allow the patient’s skin to breathe.

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Tissue damage or inaccurate measurements may be caused by incorrect SpO 2 sensor application or use, such as wrapping too tightly, applying supplemental tape, failing to inspect periodically, or failing to position appropriately. Read the Instructions for Use provided with the SpO 2 sensor carefully prior to use.

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Do not sterilize or immerse pulse oximetry sensors in liquid. Clean and/or disinfect re-usable sensors between patients.

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Pulse oximetry sensors are susceptible to high ambient light interference including surgical lights, especially xenon light sources, ambient photodynamic therapy (e.g., Bilirubin lamps), fluorescent lights, infrared heating lamps, direct sunlight. Shield the sensor area as necessary.

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

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That factors that may cause inaccurate readings and alarms, decreased perfusion, and or low signal strength include:

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