Welch Allyn S12:S19 SURVEYOR PATIENT MONITORS SERVICE MANUAL, 9516-183-50-ENGLITPDF 200k@Home Hydraulics Block Diagram Rev. C

Page 1
TABLE OF CONTENTS
1
S12/S19
SURVEYOR PATIENT MONITORS
SERVICE MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Page 2
Copyright © 2018
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc.
Mortara is a registered trademark of Mortara Instrument, Inc. Surveyor, AM12M™, and VERITAS are trademarks of Mortara Instrument, Inc.
Nellcor™, Covidien™, C-LOCK™, SatSeconds™, OxiMax, MAX™, Max-Fast™, SoftCare™, Oxiband™, Dura- Y™, PediCheck™, 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), Microstream®, Filterline® 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
Page 3
i
TABLE OF CONTENTS
1. GENERAL STATEMENTS
........................................................................................................................... 1
TECHNICAL SUPPORT AND SERVICE ................................................................................................................................ 1
2. NOTICES
.................................................................................................................................................... 2
M
ANUFACTURER’S RESPONSIBILITY
..................................................................................................................... 2
R
ESPONSIBILITY OF THE CUSTOMER
................................................................................................................... 2
E
QUIPMENT IDENTIFICATION
............................................................................................................................ 2
C
OPYRIGHT AND TRADEMARK NOTICES
............................................................................................................ 2
O
THER IMPORTANT INFORMATION
.................................................................................................................. 2
3. WARRANTY INFORMATION
.................................................................................................................... 3
Y
OUR MORTARA WARRANTY
............................................................................................................................. 3
4. USER SAFETY INFORMATION
.................................................................................................................. 5
S
AFETY REGULATIONS
......................................................................................................................................... 5
WARNINGS ............................................................................................................................................................... 5
POWER WARNINGS ..................................................................................................................................................... 6
ACCESSORIES, CABLES, AND EXTERNAL CONNECTIONS WARNINGS ......................................................................................... 8
USE WITH ELECTRO SURGERY DEVICES WARNINGS ............................................................................................................. 9
INSTALLATION AND MOUNTING WARNINGS ..................................................................................................................... 9
ECG WARNINGS ........................................................................................................................................................ 9
ECG CALCULATED HEART RATE WARNINGS .................................................................................................................. 10
WARNINGS FOR PATIENTS WITH PACEMAKERS ................................................................................................................ 11
RESPIRATION WARNINGS............................................................................................................................................ 11
SPO2 WARNINGS ..................................................................................................................................................... 11
NIBP WARNINGS ..................................................................................................................................................... 13
INVASIVE PRESSURE WARNINGS ................................................................................................................................... 14
CO2 WARNINGS ...................................................................................................................................................... 14
CARDIAC OUTPUT WARNINGS ..................................................................................................................................... 14
CAUTIONS ............................................................................................................................................................... 16
N
OTES
................................................................................................................................................................. 17
5. EQUIPMENT SYMBOLS AND MARKINGS
............................................................................................ 19
S
YMBOL DELINEATION
....................................................................................................................................... 19
6. ELECTROMAGNETIC COMPATABILITY (EMC)
................................................................................... 21
TABLE X-1 GUIDANCE AND MANUFACTURERS DECLARATION: ELECTROMAGNETIC EMISSIONS .................................................. 22
TABLE X-2 GUIDANCE AND MANUFACTURERS DECLARATION: ELECTROMAGNETIC IMMUNITY .................................................. 22
TABLE X-3 GUIDANCE AND MANUFACTURERS DECLARATION: ELECTROMAGNETIC IMMUNITY .................................................. 23
TABLE X-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE
EQUIPMENT ............................................................................................................................................................ 24
7. GENERAL CARE AND MAINTENANCE
................................................................................................ 25
P
RECAUTIONS
.................................................................................................................................................... 25
I
NSPECTION
........................................................................................................................................................ 25
C
LEANING
............................................................................................................................................................ 25
M
AINTENANCE
................................................................................................................................................... 28
B
ATTERY REPLACEMENT
.................................................................................................................................... 33
BATTERY LIFE AND CHARGE TIME ................................................................................................................................. 33
Page 4
TABLE OF CONTENTS
ii
BATTERY CONDITIONS ................................................................................................................................................ 34
D
ECOMMISSIONING AND DISPOSAL
................................................................................................................... 34
C
ALIBRATION
...................................................................................................................................................... 34
CO2 CALIBRATION .................................................................................................................................................... 34
INVASIVE PRESSURE CALIBRATION ................................................................................................................................. 35
NIBP CALIBRATION ................................................................................................................................................... 35
S12/S19 P
REVENTATIVE MAINTENANCE RECORD
.......................................................................................... 36
8. DEVICE SETUP
......................................................................................................................................... 38
O
VERVIEW
.......................................................................................................................................................... 38
P
ATIENT INFORMATION
................................................................................................................................... 38
P
ARAMETERS
...................................................................................................................................................... 38
W
AVEFORMS
...................................................................................................................................................... 39
R
ECORDER
........................................................................................................................................................... 41
A
RRHYTHMIA
..................................................................................................................................................... 42
A
LARM SUSPEND
................................................................................................................................................ 43
A
LARMS
............................................................................................................................................................... 43
A
UDIO
................................................................................................................................................................. 45
R
ESTORE DEPARTMENTAL DEFAULTS
............................................................................................................... 46
A
DMINISTRATION
.............................................................................................................................................. 46
CONFIGURATION ...................................................................................................................................................... 47
COMMUNICATIONS ................................................................................................................................................... 47
SCREEN CLEANING .................................................................................................................................................... 48
ADMINISTRATION SETUP ALARMS DIALOGUE .................................................................................................................. 48
ADMINISTRATION SETUP SYSTEM DIALOGUE................................................................................................................... 50
ADMINISTRATION SETUP SERVICE DIALOGUE .................................................................................................................. 51
ADMINISTRATION SETUP FACTORY DIALOGUE ................................................................................................................. 51
9. UNIT DISSASSEMBLY
............................................................................................................................. 52
B
ATTERY REMOVAL & REPLACEMENT
............................................................................................................. 55
R
EAR HOUSING REMOVAL & REPLACEMENT
.................................................................................................. 56
P
ROCESSOR BOARD REMOVAL & REPLACEMENT
........................................................................................... 59
M
AIN BOARD REMOVAL & REPLACEMENT
..................................................................................................... 60
LCD R
EMOVAL & REPLACEMENT
S12
................................................................................................................ 63
LCD R
EMOVAL & REPLACEMENT
S19
................................................................................................................ 64
R
EMOVAL AND REPLACEMENT OF THE OPTIONAL THERMAL WRITER
(S12 ONLY)
.................................. 66
O
PTIONAL THERMAL WRITER FOR THE
S19
...................................................................................................... 69
10.
CONFORMANCE TESTING
................................................................................................................. 82
REQUIRED EQUIPMENT: ............................................................................................................................................. 82
1.0 POWER TESTING .......................................................................................................................................... 83
2.0 FUNCTIONAL TESTING ................................................................................................................................... 83
3.0 DEVICE CLEANING ...................................................................................................................................... 111
4.0 SAFETY TESTING......................................................................................................................................... 112
11.
PRODUCT SPECIFICATIONS
.............................................................................................................. 116
G
ENERAL SPECIFICATIONS
............................................................................................................................... 116
E
NVIRONMENTAL CONDITIONS
...................................................................................................................... 116
P
OWER REQUIREMENTS & BATTERY
.............................................................................................................. 117
D
ISPLAY SPECIFICATIONS
............................................................................................................................... 117
R
ECORDER SPECIFICATIONS
............................................................................................................................ 117
M
OUNTING SPECIFICATIONS
......................................................................................................................... 118
T
RENDING
......................................................................................................................................................... 118
Page 5
TABLE OF CONTENTS
iii
12.
PARAMETER SPECIFICATIONS
.......................................................................................................... 119
P
ATIENT POPULATION
.................................................................................................................................... 119
W
AVEFORMS
.................................................................................................................................................... 119
ECG
.................................................................................................................................................................... 119
A
RRHYTHMIA ANALYSIS
.................................................................................................................................. 120
ST A
NALYSIS
..................................................................................................................................................... 121
NON-I
NVASIVE BLOOD PRESSURE
(NIBP)
...................................................................................................... 122
P
ULSE OXIMETRY (SP
O2)
................................................................................................................................ 122
T
EMPERATURE
.................................................................................................................................................. 123
R
ESPIRATIONS: VIA
ECG I
MPEDANCE
............................................................................................................ 123
C
APNOGRAPHY
(CO2)
....................................................................................................................................... 123
I
NVASIVE PRESSURES
........................................................................................................................................ 124
C
ARDIAC OUTPUT
............................................................................................................................................ 125
13.
PARAMETER ALARM LIMIT RANGES
............................................................................................. 127
A
DULT PATIENT MODE
................................................................................................................................... 127
P
EDIATRIC PATIENT MODE
............................................................................................................................. 129
14.
ALARM SPECIFICATIONS
................................................................................................................. 131
G
ENERAL ALARMS
........................................................................................................................................... 131
ECG
AND HR MESSAGES
................................................................................................................................. 131
NON-I
NVASIVE BLOOD PRESSURE
(NIBP) M
ESSAGES
................................................................................... 132
P
ULSE OXIMETRY (SP
O2) M
ESSAGES
............................................................................................................. 134
T
EMPERATURE MESSAGES
............................................................................................................................... 135
R
ESPIRATION MESSAGES
.................................................................................................................................. 136
C
APNOGRAPHY
(CO2) M
ESSAGES
.................................................................................................................. 137
I
NVASIVE PRESSURE MESSAGES
....................................................................................................................... 138
C
ARDIAC OUTPUT MESSAGES
.......................................................................................................................... 139
NETWORK MESSAGES ............................................................................................................................................. 139
15.
TROUBLESHOOTING
....................................................................................................................... 140
P
OWER AND BATTERY
..................................................................................................................................... 140
D
ISPLAY AND TOUCH SCREEN
......................................................................................................................... 140
ECG, A
RRHYTHMIA, AND
ST
........................................................................................................................... 141
NON-I
NVASIVE BLOOD PRESSURE
(NIBP)
...................................................................................................... 141
P
ULSE OXIMETRY (SP
O2)
................................................................................................................................ 142
T
EMPERATURE
.................................................................................................................................................. 142
R
ESPIRATIONS: VIA
ECG T
HORACIC IMPEDANCE
......................................................................................... 142
C
APNOGRAPHY
(CO2)
....................................................................................................................................... 142
I
NVASIVE PRESSURES
........................................................................................................................................ 143
C
ARDIAC OUTPUT
............................................................................................................................................ 143
16.
MOUNTING ACCESSORIES
.............................................................................................................. 147
Q
UICK DISCONNECT
(M-S
ERIES) WALL MOUNTING COMPONENTS
.............................................................. 147
V
ALUE (VESA
M-S
ERIES) WALL MOUNTING COMPONENTS
........................................................................... 147
P
REMIUM
(VHM-25) W
ALL MOUNT COMPONENTS
.................................................................................... 148
S
URVEYOR
S12 R
OLL STAND COMPONENTS (NOT TO BE USED WITH
S19)
.................................................... 149
Page 6
TABLE OF CONTENTS
iv
Page 7
1

1. GENERAL STATEMENTS

Technical Support and Service

Headquarters
Mortara Instrument, Inc.
7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com
European Union Representative
Via Cimarosa, 103/105 40033 Casalecchio di Reno (Bologna) Italy Tel: +39 051 2987811 Fax: +39 051 6133582 E-mail: clienti.mortarait @ welchallyn.com

Service/Technical Support Group

Mortara Instrument, Inc.
7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272)(USA) Fax: 414.354.4760 E-mail: techsupport@mortara.com
24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts
Sales Support/ Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: sales@mortara.com
Hospital Customers: orders.us@mortara.com Physician Practice:orderspc.us@mortara.com U.S. Distribution: orderspc.us@mortara.com
Mortara Instrument Germany Hofgartenstraße 16 72379 Hechingen Germany Tel.: +49 (0) 7471 98 41 14-0 Fax: +49 (0) 7471 98 41 14-90 E-Mail: info @ welchallyn.com
Mortara Instrument Netherlands “Amerika” Gebouw– 7e verdieping Hoogoorddreef 15 1101 BA Amsterdam Netherlands Tel.: 020 206 1360 E-mail: infonl @ welchallyn.com
Mortara Instrument Australia Head Office Suite 4.01, 2-4 Lyonpark Road Macquarie Park, Sydney NSW 2113 Australia Tel: 1800 650 083 Fax: +61 2 9562 0982
Mortara Instrument UK
Clinitron House, Excelsior Road Ashby de la Zouch Leicester LE65 1JG Tel: 0207 365 6780 Fax: 0207 365 9694
Page 8
2

2. NOTICES

Manufacturer’s Responsibility

Mortara Instrument, 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 Mortara Instrument, 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 Mortara Instrument, 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 Mortara Instrument, 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

Mortara Instrument, 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 Mortara Instrument, Inc.

Other Important Information

The information in this document is subject to change without notice.
Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.
Page 9
3

3. WARRANTY INFORMATION

Your Mortara Warranty

MORTARA INSTRUMENT, INC. (hereafter referred to as Mortara”) warrants that components within Mortara 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 Mortara, 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 Mortara; 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 Mortara; g) Other events outside of Mortara’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 MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.
Page 10
4
WARRANTY INFORMATION
EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE 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 A N D M O R T A R A IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
Page 11
5

4. 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 and its accessories are labeled, according to European directive 93/42/EEC (MDD), as a class IIb patient monitor, and class I medical patient monitors respectively.
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 patients 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 deter mining 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 Mortara
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.
To ensure the safety of both the patient and the device, 1.5 meters (5) of open area should surround the patient.
Page 12
USER SAFETY INFORMATION
6
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.
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.
If additional devices beyond Surveyor are connected to the patient, leakage currents through the patient might add up and should be accounted for.
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.

Power Warnings

Only use the Mortara-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
Page 13
USER SAFETY INFORMATION
7
and of transformer overload.
The device is not operative if no image appears on the screen. If the device become s 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 attempt to crush or drop the device.
o
Only use the approved Mortara 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 Mortara 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.
Page 14
USER SAFETY INFORMATION
8

Accessories, Cables, and External Connections Warnings

The patient monitor is designed to meet applicable specifications when using Mortara-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.
It is the user’s responsibility to use only approved supplies, accessories and internal parts available through Mortara Instrument, 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 Mortara Instrument, Inc.
Connected devices must stay outside of the patient environment, and must be electrically insulated from the Surveyor by a separation device, or alternatively a permanent additional safety ground must be attached to the Surveyor using the appropriate terminal at the back of the unit. Connecting additional devices to the patient monitor may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured to confirm no electric shock hazard exists.
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.
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.
Mortara-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 Mortara 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.
Page 15
USER SAFETY INFORMATION
9

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.

Installation and Mounting Warnings

Place the Surveyor on a flat and leveled surface or mount it according to the manufacturer’s instructions. 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 potentially create a hazard to patients and hospital personnel.
Only approved rolling stands and wall-mount fixtures should be used with the Surveyor.
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.
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 Surveyor Central monitoring station
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.
Patient cables intended for use with the patient monitor include series resistance (9 Kilo Ohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.
ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
Page 16
USER SAFETY INFORMATION
10
Defibrillation protection is guaranteed when the original Mortara ECG patient cables are used.
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 Mortara’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.
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.
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.
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.
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 hear t rate changes suddenly from 80 bpm to 40 or 120 bpm, as measured according to ANSI/AAMI EC13 and IEC60601-2-27.
Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor rejects tall T-Waves less than or equal to 240% of a 1mV QRS in diagnostic mode, and 70% of a 1mV QRS in monitoring
mode, as well as a Q-T interval of 350 ms measured for both diagnostic and monitoring modes according to ANSI/AAMI EC13 and IEC 60601-2-27.
The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in ANSI/AAMI EC 13 and 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 tachycardia, as measured according to ANSI/AAMI EC13 and IEC 60601-2-27 Figure 201.101 patterns B1-B2 is less than 8 seconds.
Heart rate indication is not reliable during episodes of ventricular fibrillation.
The summarized performance of the QRS recognition and classification algorithm on standard databases, as defined by ANSI/AAMI EC 57, is as follows:
Page 17
USER SAFETY INFORMATION
11
MIT Database
Performance Measures
Mortara
QRS Detection Sensitivity %
99.94
QRS Detection Positive Predictivity %
99.87
PVC Detection Sensitivity %
95.49
PVC Detection Positive Predictivity %
97.05
PVC Detection False Positive Rate %
0.220
AHA Database
Performance Measures
Mortara
QRS Detection Sensitivity %
99.86
QRS Detection Positive Predictivity %
99.90
PVC Detection Sensitivity %
93.49
PVC Detection Positive Predictivity %
98.32
PVC Detection False Positive Rate %
0.162
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.

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.
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 the ANSI/AAMI EC 13 and IEC 60601-2-27 standards.
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 the ANSI/AAMI EC13 and IEC 60601-2­27:2011standards.
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.
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 CO2 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.
Use pulse oximetry sensors specified for the correct patient mode and for the correct application position.
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.
Tissue damage or inaccurate measurements may be caused by incorrect SpO2 sensor application or use, such as
Page 18
USER SAFETY INFORMATION
12
wrapping too tightly, applying supplemental tape, failing to inspect periodically, or failing to position appropriately. Read the Instructions for Use provided with the SpO2 sensor carefully prior to use.
Do not sterilize or immerse pulse oximetry sensors in liquid. Clean and/or disinfect re-usable sensors between patients.
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.
SpO2 measurement may be adversely affected by dyes (e.g., methylene blue, indocyanine green, indigo, carmine, fluorescein) introduced into the bloodstream
That factors that may cause inaccurate readings and alarms, decreased perfusion, and or low signal strength include:
Interfering substances:
o
Carboxyhemoglobin may erroneously increase SpO2 reading.
o
Methemoglobin (MetHb) usually represents less than 1% of the total Hgb, but in the case of methemoglobinemia that can be congenital or induced by some IV dyes, antibiotics (such as sulphas,) inhaled gases etc. this level increases sharply and thus can confound the SpO2 reading.
o
Intravascular dyes (such as indocyanine green, methylene blue, etc.).
Physiological conditions:
o
Cardiac arrest
o Hypotension o Shock
o
Severe vasoconstriction
o
Severe anemia
o
Hypothermia
o
Venous pulsations
o
Ventricular septal defects (VSDs)
Sensor placement:
o
Incorrect sensor placement
o
Poor sensor fit
Any condition that restricts blood flow such as the use of a blood pressure cuff or supplemental tape, 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 patient monitors; 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 or alarms generated at the Surveyor patient monitors.
If the accuracy of any measurement does not seem reasonable, first check the patients vital signs, and then check for conditions that may cause inaccurate SpO2 readings. If the problem is still not resolved, check the monitor and the SpO2 module, cable, or sensor for proper functioning.
A pulse oximeter is not an apnea monitor. A pulse oximeter should be considered an early warning device. As a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory CO-oximeter to completely understand the patient’s condition. Check that the pulse oximetry waveform is physiological in shape.
To prevent erroneous readings, do not use physically damaged sensors, cables or modules. Discard a damaged sensor or cable immediately.
The performance of the pulse oximetry may be compromised by excessive motion including tremors or
Page 19
USER SAFETY INFORMATION
13
shivering.
Nail polish and/or artificial fingernails can affect the accuracy of pulse oximetry and should be removed.
Pulse rate measurement is based on the optical detection of a peripheral flow pulse. While a pulse rate does assist with the detection or absence of a peripheral pulse, the pulse oximeter should not be used as a replacement or substitute for ECG-based arrhythmia analysis.
In certain situations such as low perfusion or weak signal strength, such as with patients who have pigmented or thick skin, inaccurate SpO2 measurements may be reported. Verification of oxygenation should be made through other means, particularly in preterm infants, and patients with chronic lung disease, prior to instituting any therapy or intervention.
Always monitor ECG for ar rhythmia detection purposes. HR calculated from pulsatile SpO2 waveform may differ significantly from ECG HR measured values.

NIBP Warnings

Use only approved blood pressure (BP) cuffs specifically intended for use with the Surveyor patient monitors.
Use the correct size cuff for the intended limb (see indication of cuff size in cm printed on cuff) of the patient. The terminology printed on some BP cuffs like “child,” “adult,” “thigh,” etc., is only an indication of the size of the cuff and should not be used to determine if the cuff is suitable for the limb. Use the range markers on the BP cuff’s to determine whether a particular cuff fits the patients arm or not.
The Surveyor patient monitor is not intended for use with neonates.
Do not fold, clamp, cut, or alter the pressure hose of the cuff or the monitor.
Periodically check the limb connected to the cuff for adequate perfusion, circulation, and function. Repeated NIBP measurements can lead to hematomas, limb ischemia, and other limb injuries. Kinked or blocked hoses can lead to prolonged impairment of blood circulation and lead to injury.
Educate the patient to relax, rest, and lie still during inflation and pressure measurements. Patient movement can lead to artifacts or errors.
The pressure measurement might be influenced by patient position, physical conditions, and other factors.
Avoid placing the blood pressure cuff on the arm next to where a patient has had a mastectomy.
Avoid applying the cuff to a wounded limb as this can cause further injury. Use with caution in patients with dermatological disease, subcutaneous laceration, or other integumentary compromise as there may exist a skin damage hazard during electronic NIBP measurements. Follow prudent evidence-based clinical practice to determine if an electronic blood pressure is safe for these patients.
There may be an increased risk of hematomas in patients with serious coagulation problems.
Avoid applying the cuff to a limb with a catheter, arterio-venous shunt or infusion pump applied. The cuff pressure could produce damage to the tissues surrounding the catheter, shunt or the infusion needle, or compromise the infusion flow.
To avoid the potential for spread of disease or infection, reusable blood pressure cuffs should be cleaned after each patient use. Disposable blood pressure cuffs should not be used with multiple patients.
Inflation of the NIBP cuff can cause a temporary degradation of monitoring of other parameters derived from the same limb, including invasive pressure and SpO2 measurements. If applicable, place the SpO2 sensor and the NIBP cuff on different limbs.
Page 20
USER SAFETY INFORMATION
14
An irregular heart beat (arrhythmia) causes beat-to-beat blood pressure variations and may therefore disturb the NIBP measurement, which may fail or be inaccurate. It is advisable to confirm automatic NIBP measurements periodically for patients with frequent premature beats or a very irregular heart rate, for example caused by atrial fibrillation.
NIBP measurements may be inaccurate or fail in the presence of excessive movement, shivering, or trembling. Advise patients to relax and avoid moving when a blood pressure measurement is made.
NIBP cuffs and hoses supplied with the Surveyor do NOT contain any Latex. If the patient develops an allergic
reaction or rashes, immediately remove the cuff.

Invasive Pressure Warnings

All invasive procedures involve risks to the patient. Use aseptic technique. Follow catheter manufacturer's instructions and established hospital guidelines.
Ensure that no part of the patient connections touches any electrically conductive material including earth.
Only use invasive pressures transducers that can withstand defibrillation as required by ANSI/AAMI BP22 standard.
Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero balance and calibration, and cause erroneous readings.

CO2 Warnings

Always inspect the airway adapter for a tight connection and proper operation before attaching it to the patient.
Remove the airway sampling line from the patient’s airway while nebulized medications are being delivered.
Route all tubing away from the patient’s throat to avoid strangulation.
Do not apply pressurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.
When monitoring an anesthetized patient in an operating room environment, it is recommended to connect the CO2 exhaust port of the Surveyor to the hospital’s waste gas scavenging system so as to prevent exposure for other patients and hospital personnel to the patient’s respiratory sample. Ensure that sampled gases are not returned from the exhaust port to a breathing system such as a ventilator. Use standard clinical guidelines and/or hospital procedures. Scavenge vacuum greater than 1mmHg may result in damage to the Surveyor.
When using a sampling line for intubated patients with a closed suction system, do not place the airway adapter between the suction catheter and endotracheal tube. This is to ensure that the airway adapter does not interfere with the functioning of the suction catheter.
Loose or damaged connections may compromise ventilation or cause an inaccurate measurement of respiratory gases. Securely connect all components and check connections for leaks according to standard clinical procedures.
Do not cut or remove any part of the sample line. Cutting the sample line could lead to erroneous readings.
If too much moisture enters the sampling line (i.e., from ambient humidity or breathing of unusually humid air), the message CO2 Purging Line will appear in the message area. If the sampling line cannot be cleared, the message CO2 occluded line will appear in the message area. Replace the sampling line once the CO2 occluded line message appears.

Cardiac Output Warnings

Page 21
USER SAFETY INFORMATION
15
Refer to the catheter package insert provided with each PA catheter for the appropriate computation constant, specific instructions on catheter placement and use, warnings, cautions, and specifications.
Inaccurate Cardiac Output measurements may be caused by:
o
Incorrect placement or position of the catheter.
o
Excessive variation in pulmonary artery blood temperature, perhaps caused by bolus drug administration.
o
Clot formation on the thermistor port.
o
Anatomical abnormalities, (for example, cardiac shunts).
o
Excessive patient movement.
o
Repeated intermittent flushes of cold fluid through the fluid lumens of the catheter.
o
Electrocautery or electrosurgical device interference.
o
Rapid changes in cardiac output.
o
Using an incorrect computation constant.
Page 22
USER SAFETY INFORMATION
16

Cautions

Cleaning must be performed with the system turned off. Let all parts dry well before turning the power back on.
Prevent liquids from penetrating the system, components, and transmitters. Do not spray the system with liquid cleaning agents. If liquids have penetrated the system, open by authorized personnel for inspection and let dry completely.
Do not attempt to clean the patient monitor or patient cables by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth. 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 patient monitor.
No user-serviceable parts inside. Screw removal by authorized service personnel only. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by authorized service personnel prior to continued use.
The rechargeable internal battery is a sealed lithium ion type. If the battery appears to become defective, refer to Mortara Technical Support.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. When not in use, patient cables can be stored. Keep patient cables should be stored off of the floor away from bedrails and wheels to avoid cable damage. Roll the patient cables into a loose loop prior to hanging for storage.
When necessary, dispose of the patient monitor, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations.
Do not connect the patient monitor to any unauthorized patient monitors or use any third-party accessories. This may cause inaccurate measurements or harm the patient. Installation and connection to data networks must be performed by properly trained personnel, authorized by Mortara.
Check that all operating and environment conditions such as ambient temperature meet the specifications of the Surveyor.
Do not exert excessive pressure on the touch panel LCD. Excessive pressure may permanently damage the display.
During MRI scanning, the module must be placed outside the MRI suite. When the module is used outside the MRI suite, EtCO2 monitoring can be implemented using the FilterLine XL.
Use of a CO2 sampling line with H in its name (indicating that it is for use in humidified environments) during MRI scanning may cause interference. The use of non H sampling lines is advised.
Page 23
USER SAFETY INFORMATION
17
Microstream® etCO2 sampling lines are designed for single patient use, and are not to be reprocessed. Do not attempt to clean, disinfect, sterilize or flush any part of the sampling line as this can cause damage to the monitor.
Dispose of sampling lines according to standard operating procedures or local regulations for the disposal of contaminated medical waste.
Before use, carefully read the Microstream® etCO2 sampling lines Directions for Use.
Only use Microstream® etCO2 sampling lines to ensure the monitor functions properly.

Notes

The Surveyor’s NIBP parameter is indicated for use with pregnant patients, including those with pre-eclamptic or eclamptic conditions.
Patient movements may generate excessive noise that may affect the quality of signals and derived parameters and waveforms.
Proper patient preparation is important to proper application of sensors and electrodes to ensure the correct operation of the patient monitor.
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the patient monitor; however, disturbance to the signal may occur.
If an ECG electrode is not connected properly to the patient, or one or more of the patient cable lead wires are damaged, the display will indicate a lead fault for the lead(s) where the condition is present and if the signal is being printed, the respective lead(s) will print out as blank.
This patient monitor is intended to be used in a hospital or doctor’s office setting, and should be used and stored according to the environmental conditions specified.
During nebulization or suction for intubated patients, in order to avoid moisture buildup and sampling line occlusion, remove the sampling line luer connector from the monitor.
Replace the sampling line according to hospital protocol or when a blockage is indicated by the device. Excessive patient secretions or a buildup of liquids in the airway tubing may occlude the sampling line, requiring more frequent replacement.
When the caution message “Blockage appears on the screen, indicating that the FilterLine which is attached to
the monitor is blocked, the monitors CO2 pump will stop pumping the patient’s breath into the monitor for testing. Follow the instructions that appear in the Troubleshooting section of this manual: First disconnect and reconnect the FilterLine. If the message still appears, disconnect and replace the FilterLine. Once a working
FilterLine is attached to the monitor, the pump will automatically resume operation.
Following connection of the CO2 sampling line to the monitor and patient, check that CO2 values appear on the monitor display.
Page 24
USER SAFETY INFORMATION
18
The device is ETL listed:
ETL-Listed device in the USA and Canada.
Upon request, Mortara can supply a Service Manual that includes additional calibration and test instructions as well as list of spare parts and accessories that must be used with the Surveyor patient monitors.
Page 25
19

5. EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation

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.
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
IPX1
Indicates device has been tested for safety from vertically dripping water; specifically, it indicates DRIP PROOF, a higher than ordinary level of protection from drips, leaks, and spills
Defibrillator-proof type CF applied part
Tested for safety by the Intertek according to applicable U.S. and Canadian standards and requirements
External power AC/DC power supply; use only Mortara Power Supply; REF 4101-012
Power On/Off switch
Consult accompanying documents
Local Area Network interface
External alarm interface
Interface to external devices – Reserved for future use
Connector for 3/5 lead ECG parameter
Connector for 12-lead ECG parameter using Mortara AM12M
Connector for non-invasive blood pressure parameter
Connector for oxygen saturation parameter
CO
Connector for cardiac output parameter
Connector for invasive pressure 1 & 2 parameters
Connector for invasive pressure 3 & 4 parameters
Connector for temperature 1 parameter
Connector for temperature 2 parameter
Page 26
EQUIPMENT SYMBOLS AND MARKINGS
20
Connector for CO2 parameter
Connector for CO2 parameter exhaust port
Catalog number for relevant Mortara part
Serial number
This end up
Keep away from sunlight
Fragile, handle with care
Keep dry
Storage temperature range
10 rolls of recorder paper per case Recorder interface (S19 only)
SN
Page 27
21

6. ELECTROMAGNETIC COMPATABILITY (EMC)

When using the patient monitor, assess the electromagnetic compatibility with surrounding devices.
An electronic device may either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the bedside monitor according to the international standard for EMC for medical bedside monitors (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The patient monitor should not be used adjacent to or stacked with other equipment. If the patient monitor is used in this manner, verify the patient monitor operates in an acc eptable manner in the configuration in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment may affect the performance of medical equipment. See Table X-4 for recommended separation distances between the radio equipment and the patient monitor.
The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the equipment.
Page 28
ELECTROMAGNETIC COMPATABILITY (EMC)
22

Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions CISPR 11
Group 1
The Surveyor patient monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class A
The Surveyor patient monitor is suitable for use in all establishments other than domestic and those directly connected to the public low­voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions IEC 61000-3-2
Not Applicable
Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3
Not Applicable

Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment: Guidance
Electrostatic discharge (ESD) EN 61000-4-2
+/- 6 kV contact +/- 8 kV air
+/- 6 kV contact +/- 8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst EN 61000-4-4
+/- 2 kV for power supply lines +/- 1 kV for input/output lines
+/- 2 kV for power supply lines +/- 1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
+/- 1 kV differential mode +/- 2 kV common mode
+/- 1 kV differential mode +/- 2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage fluctuations and interruptions
<5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles <5% UT for 5s
<5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles <5% UT for 5s
Note that monitoring is interrupted at the level < 5% UT for 5s”, but equipment remains safe (as specified in EN 60601-1-2).
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.
Page 29
ELECTROMAGNETIC COMPATABILITY (EMC)
23

Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment: Guidance
Conducted RF EN 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms 150 kHz to 80 MHz
Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2
d = 1.2 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:
Radiated RF IEC 61000-4­3
3 V/m 80 MHz to
2.5 GHz
3 V/m 80 MHz to
2.5 GHz
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.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
Page 30
ELECTROMAGNETIC COMPATABILITY (EMC)
24

Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment

The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.
Rated Maximum Output Power of Transmitter (W)
Separation Distance According to Frequency of Transmitter (m)
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2
d = 1.2
d = 2.3
0.01
0.12 m
0.12 m
0.23 m
0.1
0.38 m
0.38 m
0.73 m
1
1.2 m
1.2 m
2.3 m
10
3.8 m
3.8 m
7.3 m
100
12.0 m
12.0 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.
Page 31
25

7. GENERAL CARE AND MAINTENANCE

Precautions

Power off the patient monitor before inspecting or cleaning.
Protect the patient monitor from liquids.
Never immerse the patient monitor in water.
Do not drop the patient monitor or subject to shock and/or vibration.
Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may damage equipment surfaces.

Inspection

Inspect your equipment daily prior to clinical operation. Do not use the equipment and contact an authorized service representative for servicing if there are concerns about integrity of the system.
Verify that all cords and connectors are securely seated.
Check the case and chassis for any visible damage.
Inspect cables, cords, and connectors for any visible damage.
Inspect keys and controls for proper function and appearance.
Check for neat and well balanced screen images.
Inspect patient accessories such as cuffs, sensors, and wires for any visual damage.
Ensure that auditory and visual alarms are available and working appropriately.

Cleaning

The following section provides information on proper cleaning directions for the Surveyor patient monitor and patient accessories. Accessories should be cleaned before they are applied to a new patient. The patient monitor should be cleaned as per facility standard of care. Before cleaning, please refer to the cautions listed below.
CAUTION: Always disconnect the Surveyor patient monitor from AC (wall) mains power before
cleaning.
CAUTION: Do not use harsh chemicals for cleaning. Do not use disinfectants that contain phenol
as they can spot plastics. Do not steam autoclave, gas sterilize, irradiate, subject to intense vacuum, or immerse in water or cleaning solution. Be careful to avoid getting cleaning liquids into connectors or the patient monitor. If this occurs, allow the patient monitor to dry in warm air for 2 hours, then check to make sure all monitoring functions are working properly.
CAUTION: Take particular care when cleaning the NIBP cuff, NIBP hose, and NIBP connector
on the Surveyor patient monitor to prevent fluid from entering the connectors or cuff. Fluid in the NIBP system may affect blood pressure determination accuracy and damage the monitor.
Page 32
GENERAL CARE AND MAINTENANCE
26
CAUTION: Keep the patient accessories off of the floor. Accessories that fall on the floor should
be inspected for defects, contamination, proper functionality, and cleaned or discarded according to the approved recommendations.
CAUTION: The user has the responsibility to validate any deviations from the recommended
method of cleaning and disinfection.
Touch screen Display
Approved Cleaning Agents
Clean the touch screen with a soft cloth moistened with either a solution of 70% isopropyl alcohol in distilled water or soapy water.
Do not spray cleaner directly onto the touch screen. Spray the cleaner onto a lint-free cloth and then wipe the monitor.
To clean the touch screen display,
1. Select the Settings sidebar button.
2. Select the Administrative menu.
3. Select the Screen Cleaning mode. This action disables the monitor’s touch screen for 15 seconds for cleaning purposes. After the 15 seconds expires, the touch screen controls are reactivated.
ECG Cables
TEMP Cable
SpO2 Cable
NIBP Hose
External Power Supply
Power Cord
Approved Cleaning Agents
Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US)
Distilled water
Disinfectant solution (such as CIDEX OPA, or a 10% solution of household bleach (5.25% sodium hypochlorite) in distilled water)
Soft, lint-free cloths and/or soft-bristled brushes
Protective gloves and eyewear
Procedure
1. Disconnect the patient monitor from the wall outlet.
2. Put on gloves and protective eyewear.
3. Prepare the enzymatic detergent according to the manufacturer's instructions, and also the disinfectant solution, in separate containers.
4. Apply detergent to product using a soft, lint-free cloth. If material is dried on, allow to sit for 1 minute. Do not immerse cable ends or lead wires in liquid as it can cause corrosion.
5. Wipe smooth surfaces with the cloth.
6. Use a soft-bristle brush on visibly soiled areas and irregular surfaces.
7. Remove detergent from product using cloth dampened in distilled water.
8. Repeat as necessary.
9. Apply disinfectant solution on affected area using a soft cloth. Allow product to sit for 5 minutes.
10. Wipe excess solution and clean product again with cloth dampened in distilled water.
11. Allow 2 hours for drying.
Page 33
GENERAL CARE AND MAINTENANCE
27
Reusable NIBP Cuffs
Approved Cleaning Agents
Mild detergent and water
Non-chlorine bleach
Procedure
1. Prior to washing, remove any internal cuff bladders and engage the Velcro hook and loop fasteners to prevent lint from collecting in the hooks.
2. For general cleaning of cuffs, use a soft, lint-free cloth lightly moistened with a mild soap and water solution. Be careful not to get liquid inside the tubes. Allow to air dry.
3. For excessive perspiration marks or odor, the exterior of the cuff can be hand-washed under running water with a mild detergent. Do not allow water to enter the cuff. Allow to air dry.
4. If required, the use of non-chlorine bleach is acceptable. Using chlorine bleach solutions will shorten the service life of the cuff.
5. Sterilize the cuff using commercially available disinfectants. Using dark colored disinfectants may stain the cuff material. Test a single cuff to ensure that no damage or staining occurs. Follow the manufacturer’s instructions. Thoroughly rinse each component to remove any residual disinfectants. Once cleaned, wash off all disinfectant material using a cloth dampened with a mild detergent. Failure to remove disinfectants may lead to mild skin irritation on some patients. Allow the components to air dry for a minimum of 2 hours.
6. Cuffs may be sterilized with Ethylene Oxide. Do not autoclave or iron the cuff as the hook and loop fasteners will melt at temperatures above 325°F (162°C).
7. Use caution with excess liquid.
8. Do not use excessive drying techniques such as forced heat.
9. Prevent liquid from penetrating the cuff and do not attempt to clean/disinfect the cuff by submerging into liquid, autoclaving, or steam cleaning.
SpO2 Reusable Sensor
Approved Cleaning Agents
70% isopropyl alcohol
Procedure
1. Remove sensor from patient and disconnect from sensor cable. Wipe off with alcohol pad.
2. Allow sensor to dry before placing it on a patient.
Disposable:
SpO2 Sensors Temperature Probes CO2 Lines
These items are intended for use with a single-patient and must be properly disposed of after use. Refer to the sensor/probe manufacturer instructions for further details.
Page 34
GENERAL CARE AND MAINTENANCE
28

Maintenance

The following table shows the recommended maintenance procedures for the Surveyor patient monitor and its accessories. The Surveyor S12 and S19 patient monitors should be serviced and calibrated once a year by a Mortara authorized service technician. However, it is good practice to periodically ensure the patient monitor is in proper working order. Perform these checks at least every 12 months by a qualified biomedical engineer or other trained service personnel. To accomplish these steps in their entirety and verify the correct operation of the system, appropriate patient simulators or other equipment may be required.
Functionality
Procedure
Mechanical Integrity
Check for cracks, abrasive edges and other signs of damage.
Power LED
Verify that the green power LED is illuminated when the patient monitor is ON or charging.
Speaker
Power-cycle the Surveyor patient monitor and verify that the power-up speaker test tones are generated.
Second Speaker
Power-cycle the Surveyor patient monitor and verify that the power-up second speaker test tones are generated.
ECG / Respiration
Connect ECG leads to Patient Simulator.
Verify proper heart rate at 30 and 300 bpm (+/- 2 bpm or +/- 1%).
Verify 1 mV test pulse (Lead II).
Verify proper respiration rate at 15 and 120 bpm (+/- 3 bpm).
SpO
2
Connect to Patient Simulator (select appropriate sensor type).
Verify proper SpO2 value at 84% and 96% (+/- 2%).
Verify proper PR value at 30 and 240 bpm (+/- 5%).
CO2
NOTE: Use only certified calibration gas apparatus [See “CO2 Calibration section below] that has not reached its expiration date. This cal gas can be applied to the Surveyor patient monitor in pulses that simulate patient breaths.
1.
NOTE: Between calibrations, the ETCO2performance parameters and tolerance can be verified as needed as well as during preventive maintenance. The calibration gas should be applied to the Surveyor patient monitor in pulses of 5 seconds on and 5 seconds off, to simulate patient breaths of 5-6 RR. Continue long enough for the ETCO2 to stabilize in both inhale and exhale states. The ETCO2 value should read 38 ± 2 mmHg. The FICO2 value should read 0 ± 2 mmHg and a ± 0.05 correction factor for every 100 mmHg ambient pressure above or below sea level, respectively. Connect an Oridion
Microstream FilterLine single-use capnography sample line to the Surveyor monitor’s gas inlet port.
2. Connect with a tight fit, the other end of the Oridion sample line to one of the two open ports on the Cal Gas tubing apparatus.
3. Pulse the calibration gas actuator, holding it depressed for 5 seconds and released for 5 seconds (5-6 RR). This will allow enough time for the ETCO2 to stabilize in both inhaled and exhaled states.
4. Verify that the EtCO2 value reads the CO2 concentration stated on the canister ± the accuracy tolerance stated in the product specifications.
5. Verify the FiCO2 value reads 0 ±2 mmHg.
NOTE: Factor a ±0.05 correction for every 100mmHg of ambient barometric pressure above or below sea level respectively.
NOTE: The monitor should be returned to the manufacturer for periodic servicing of the CO2 system after 30,000 hours of CO2 use.
Page 35
GENERAL CARE AND MAINTENANCE
29
Functionality
Procedure
NIBP
NOTE: Do not allow system to remain pressurized and stable below 20 mmHg. The monitor will remove this pressure as a zero offset and this will affect the validity of the calibration check.
NOTE: The following are required to perform this test: NIBP simulator or sphygmomanometer along with a Y-cable and a hand inflation bulb.
Pressure Accuracy Test: Via the Service settings, put the NIBP in to calibration mode. Set the pressure to 25 mmHg and 225 mmHg respectively and verify that the pressure values reported by the Surveyor patient monitor matches ((±2 mmHg) of that reported on the simulator or sphygmomanometer. Release pressure.
Overpressure Test: Inflate cuff to 300 mmHg. Verify that the pressure is automatically dumped at 300 +/- 30 mmHg.
Leak Test: Inflate a cuff to 150 mmHg. Allow cuff pressure to settle (thermal effect). Verify that the pressure drops less than 4 mmHg in 1 minute. Verify that the pressure is automatically dumped after 180 seconds.
Set the NIBP back to normal mode. Power cycle the monitor.
Measurement Accuracy Test: Connect to Patient Simulator and take a NIBP measurement. Verify proper NIBP value at 120/80 (+/- 5 mmHg).
Invasive Pressures (P1-P4)
Connect static pressure sources at 20 and later at 100 mmHg to IBP sensors P1-P4. Verify correct pressure is displayed for each (+/- 2 mmHg).
Connect a patient simulator with dynamic IBP waveform for radial artery of120/80.
Verify correct pressure waveform and values are displayed (+/- 2 mmHg).
Temperature
None (self-checking).
Page 36
GENERAL CARE AND MAINTENANCE
30
Safety Testing
If the monitor housing was opened for repair or inspection work, the following safety tests should be performed in accordance with the IEC 60601-1 or IEC 62353 methods and limits.
The S12 and S19 are considered a Class 1 Type CF devices, intended to be utilized with the Mortara specified patient modules and product accessories.
DC Hi-pot Testing Applies to all of the following optional patient inputs (applied parts) installed on the monitor being tested. Test
connectors are required to properly connect test equipment to the applied part inputs to perform Hi-pot testing. The negative (black) connection of the tester should be connected to the DC Power Input via TF0571 (or equivalent). The positive (red) lead wire is connected to the connection defined below.
The ECG input should be tested separately, and the other applied parts (SpO2, Temp, CO) can be connected together via a shorting bar (as shown in the diagram below) to expedite the testing process. This is not a
requirement and the tests can be performed separately.
Connection
Test Connector/Method
ECG
Patient cable 9293-050-60 and shorting bar
SpO2
TF0281
Temp 1, Temp 2
TF0559
Cardiac Output
TF0558
Item
Value
Unit of Measure
Boundary
Applied Potential
5000
Volts DC
Minimum
Ramp Time
3.0
Seconds
Minimum
Dwell Time
1.0
Seconds
Minimum
Current High
0.500 (500 uA)
mA
Maximum
Current Low
0.0
mA
Minimum
Page 37
GENERAL CARE AND MAINTENANCE
31
Nurse call / Ethernet Test: The ports on the back of the device (nurse call/ethernet) are tested at a different voltage as defined below. The negative (black) connection of the tester should be connected to the DC Power Input via TF0571 (or equivalent). The positive (red) lead wire is connected to TF0570.
Connection
Test Connector/Method
Nurse Call/Ethernet
TF0570
Item
Value
Unit of Measure
Boundary
Applied Potential
1000
Volts DC
Minimum
Ramp Time
3.0
Seconds
Minimum
Dwell Time
1.0
Seconds
Minimum
Current High
0.500 (500 uA)
mA
Maximum
Current Low
0.0
mA
Minimum
AC Hi-pot Testing Applies to all of the following optional patient inputs (applied parts) installed on the monitor being tested. Test
connectors are required to properly connect test equipment to the applied part inputs to perform Hi-pot testing. The negative (black) connection of the tester should be connected to both the Line and Neutral on the AC side of the external AC/DC Power Module (Item # 4101-012), typically by utilizing tool TF-0107. The positive (red) lead wire is connected to the connection defined below.
The ECG input should be tested separately, and the other applied parts (SpO2, Temp, CO) can be connected together via a shorting bar (as shown in the diagram below) to expedite the testing process. This is not a
requirement and the tests can be performed separately.
Connection
Test Connector/Method
ECG
Patient cable 9293-050-60 and shorting bar
SpO2
TF0281
Temp 1, Temp 2
TF0559
Cardiac Output
TF0558
Item
Value
Unit of Measure
Boundary
Applied Potential
3000
Volts AC
Minimum
Ramp Time
3.0
Seconds
Minimum
Dwell Time
1.0
Seconds
Minimum
Current High
0.500 (500 uA)
mA
Maximum
Current Low
0.0
mA
Minimum
For Brazil testing, dwell time is increased to 60 seconds.
Page 38
GENERAL CARE AND MAINTENANCE
32
ECG Input Connection Diagram:
Applied Part Connection Diagram:
Leakage Testing
The factory External AC/DC Power Module (Item # 4101-012) and appropriate regional AC power cord should be used to perform the leakage tests defined below.
Earth Leakage Enclosure Leakage
Non-conductive (fully insulated) chassis testing should be performed utilizing 200 cm2 conductive foil or equivalent.
Patient Leakage
Applied part – patient input (utilize Mortara patient cable 9293-050-60 or -61)
Patient Leakage (mains on applied part)
Applied part – patient input (utilize Mortara patient cable 9293-050-60 or -61)
Page 39
GENERAL CARE AND MAINTENANCE
33

Battery Replacement

CAUTION: The battery should be removed from the monitor if the monitor is to be stored for an
extended period of time.
The battery may need to be replaced if it is no longer holding a charge. Under optimum conditions, the battery
lifetime is approximately two years. Replacing the battery should only be done by qualified service personnel.
WARNING: Use only APPROVED BATTERIES as listed in the Accessories section. Use of
unapproved batteries may cause a hazard and will void the warranty.
CAUTION: Batteries should only be replaced by trained service personnel.
To replace the battery:
1. Obtain a replacement battery from Mortara (see Accessories section for part number).
2. Power-off the Surveyor patient monitor.
3. On the back of the Surveyor patient monitor, disconnect the external power supply from the monitor.
4. Remove the battery cover with the VESA mounting plate by removing the four screws holding the cover as shown in the picture below.
5. Remove the battery by pulling on the top side of the battery as shown in Figure 1.
6. Insert new battery ensuring that the connector is properly engaged.
7. Carefully reinstall back cover and screws.
8. Properly dispose of the old battery (see Disposal section).

Figure 1 Battery Replacement

Battery Life and Charge Time

Estimated Battery Life
S12: 3 hours* S19: 2 hours*
*Fully charged new batteries at 25 °C for the following conditions: continuous ECG and SpO2, as well as NIBP measurements at every 15 minute interval.
Estimated Battery Charge Time
When OFF, 5 hours When ON, S12: 7 hours When ON, S19: 20 hours
Page 40
GENERAL CARE AND MAINTENANCE
34

Battery Conditions

When the Surveyor S12 and S19 monitor’s battery has less than 5 minutes of power remaining, the battery icon
flashes, a battery alert message displays, and an audio technical tone is sounded.
When the battery power is too low to continue normal operation, the Surveyor S12 and S19 monitor’s screen clears, a Battery Nearly Depleted message displays in the center of the screen, and monitoring is discontinued. When AC power is restored, the battery begins the recharge process and monitoring can resume once the clinician has powered on the monitor.

Decommissioning and Disposal

Dispose of the patient monitor, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. Do NOT incinerate or throw the battery in garbage.

Calibration

Mortara recommends Surveyor S12 and S19 patient monitors be serviced annually by an authorized service technician.
Please read the calibration section in its entirety before beginning service.

CO2 Calibration

The CO2 module is calibrated by the manufacturer, therefore a new patient monitor can be put into clinical use without the need of calibration. The Surveyor patient monitor displays a “CO2 Calibration Due” message when the manufacturer’s suggested number of operating hours has been reached. In the first calibration cycle, the CO2 module should be calibrated after 1200 hours of use. Subsequent calibration cycles are alerted after 4000 hours of use. The number of hours until calibration is due may be found in the Surveyor patient monitor’s event log, which is accessed via the “Administration – System – Show Event Log” menu.
NOTE: Calibration should be performed by a trained technician.
NOTE: Verify the calibration gas has not expired.
NOTE: After calibration, the device’s next-calibration timer automatically resets to 4000 hours, unless the calibration was done prematurely (less than 720 hours after the last calibration), in which case it is reset to 1200 hours. It is therefore recommended to perform calibration only when the device has been displaying the “CO2 Calibration Due message.
NOTE: Calibration of the CO2 module will require a calibrated gas mixture of 5% CO2, 21% O2, with the balance N2. The calibration kit available from Air Liquide (Scott Medical); Part Number T4653ORF­CD contains a canister of the above gas mixture, a T-piece connector and a Calibration Filterline.
Page 41
GENERAL CARE AND MAINTENANCE
35
To calibrate the CO2 module:
1. Prepare the gas apparatus by attaching the sample line to the calibration gas canister. Mate the shorter
of the two orange connectors of the sample line with the clear connector found on the larger tubing, all supplied with the calibration kit. Verify that the gas apparatus is functioning properly by very briefly depressing the actuator and listening for gas expulsion. Set aside.
2. Power on the S12/19 device and verify the ETCO2 function is enabled by navigating through the
following menus: Setup > Parameters > ETCO2 Enabled = Yes > OK > Close.
3. Connect the CO2 sampling line to the S12/19 device by inserting the orange connector into the
Microstream receptacle and turning clockwise half a turn. Do not over tighten.
4. Navigate through the following menus: Setup > Administration > Service > Code Entry 53, 51, 54 >
OK > Calibration.
5. Select Start CO2 Calibration on the screen while immediately depressing and holding the gas canister
actuator/trigger for approximately 1 minute. The Surveyor patient monitor will display “CO2 Calibrating” at the bottom of the screen.
6. Once completed, the Surveyor patient monitor displays CO2 Calibration Okay” or CO2 Calibration
Failed”.
7. If the calibration fails, determine the cause of the failure appropriate to the displayed error message
given. Repeat the CO2 procedure. If the calibration is unsuccessful after 3 attempts, contact Mortara Technical Support.
8. Upon successful completion, disconnect the calibration gas and hold the power button to power down
the S12/19 device. It is not necessary to exit out of the calibration menus.
9. Turn monitor on and reconnect the CO2 sampling line to the S12/19 device in preparation for verifying
ETCO2 performance is within specified tolerances.
10. Apply the calibration gas to the Surveyor patient monitor in pulses of 5 seconds on, 5 seconds off, to
simulate patient breaths of 5-6 RR. Continue long enough for the ETCO2 to stabilize in both inhale and exhale states, or approximately 1.5-2 sweeps across the screen. The ETCO2 value should read 38 ± 2 mmHg. The FICO2 value should read 0 ± 2 mmHg and a ± 0.05 correction factor for every 100 mmHg ambient pressure above or below sea level, respectively.

Invasive Pressure Calibration

The Invasive Pressure interfaces are calibrated by the manufacturer therefore a new patient monitor can be put into clinical use without the need of calibration. Annual Invasive Pressure calibration is recommended after the first year of use.
In order to calibrate the Invasive Pressure interfaces, perform the following steps:
1. Connect a static pressure source, such as ambient air, to pressure transducer that is connected to the P1
invasive pressure interface.
2. Select Start P1 Calibration” via the “Administration - Service – Calibration” screen (password
required to access this screen).
3. Await P1 Calibration OK” message, or similar if the interface is labeled something other than P1.
4. Repeat for interfaces P2 through P4.

NIBP Calibration

The NIBP module is calibrated by the manufacturer therefore a new patient monitor can be put into clinical use without the need of calibration. The accuracy of the NIBP pressure sensor and overall functionality of the NIBP interface can be verified as detailed in the Maintenance section in this manual. Based on the results of the verification testing, calibration may be required.
If further calibration is required, contact Mortara Technical Support or your authorized service personnel.
Page 42
GENERAL CARE AND MAINTENANCE
36

S12/S19 Preventative Maintenance Record

Unit Serial #:
1.0 □ Mechanical Integrity
2.0
Device Cleaning
3.1
Functional Testing
Power LED PASS / FAIL (circle) Speaker Test PASS / FAIL (circle) Second Speaker Test PASS / FAIL (circle) ECG/Respiration PASS / FAIL (circle) SpO2 PASS / FAIL / N/A (circle) CO2 PASS / FAIL / N/A (circle) NIBP PASS / FAIL / N/A (circle)
Pressure Accuracy (+/- 2mmHg) 25,
______
mmHg 225, _______mmHg Overpressure Leak Test Measurement Accuracy
mmHg (300 +/- 30 mmHg) mmHg drop (<4mmHg after 1 min)
/
mmHg (monitor reading)
IBP (P1P4) PASS / FAIL / N/A (circle) Temperature PASS / FAIL / N/A (circle)
4.0 Calibration
CO2
Cal performed / Not performed (circle one)
IBP (P1P4)
NIBP
Cal performed / Not performed (circle one) Cal performed / Not performed (circle one)
If calibration was performed, a second test record should be completed to verify proper operation.
5.0 Safety Testing
DC Hi-pot Testing (ECG and applied parts)
PASS / FAIL
DC Hi-pot Testing (nurse call/ethernet)
PASS / FAIL
AC Hi-pot Testing (ECG and applied parts)
PASS / FAIL
Leakage Testing (attach test report)
PASS / FAIL
Overall Testing Results PASS / FAIL (circle)
Performed by:
Date:
/
/
Page 43
GENERAL CARE AND MAINTENANCE
37
Page 44
38

8. DEVICE SETUP

Overview

The Setup quick action key provides access to advanced functions such as arrhythmia settings, alarm settings, and other monitor configuration menus.

Example Setup Dialogue

Patient Information

The Patient Information button provides access to the Patient Information dialogue. Access to this dialogue can also be obtained by selecting the black patient information area located above the system date and time.
Information that can be entered includes Last Name, Middle Initial, First Name, ID, Room number, Mode, Gender, Ethnicity, Date of Birth, Height and Weight.
Refer to the Patient Information dialogue section in this manual for further details.
To access the Patient Information dialogue from the Setup dialogue:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Patient Information button to access the Patient Information dialogue.

Parameters

The Setup Parameters dialogue is where the clinician can enable and disable the monitoring of certain parameters. Disabling a parameter removes that parameter from the patient monitor’s main screen.
Page 45
DEVICE SETUP
39

Example Setup Parameters Dialogue

To enable/disable a parameter:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Parameters button to access the Setup Parameters dialogue.
3. Locate the parameter label.
4. For ST Enabled, ETCO2 Enabled, and CO Enabled: a. Select Yes to enable the parameter. b. Select No to disable the parameter.
5. For IBP Channels, select the arrow to display the drop down list box: a. Select 2 to enable P1 and P2. b. Select 4 to enable P1, P2, P3, and P4. c. Select None to disable all invasive pressure channels.
6. For Temperature Display Mode, select the arrow to display the drop down list box: a. Select T1 only to display only T1 on the main screen. b. Select T1 and T2 to display both temperatures on the main screen. c. Select T1 and L'T to display T1 and L'T on the main screen.
7. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Waveforms

The Setup Waveform Area dialogue is where the clinician can choose which waveforms are displayed on the main screen, the size of those waveforms, and the sweep speed of those waveforms. This dialogue is also where the clinician can choose to overlap the invasive pressures on the main screen.
Page 46
DEVICE SETUP
40

Example Setup Waveform Area Dialogue

To select a waveform for display on the main screen:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Waveforms button to access the Setup Waveform Area dialogue.
3. The numbers 1-7 indicate waveform position on the main screen. a. Waveform position #1 is always reserved for an ECG tracing.. b. Waveform positions #4-7 are always reserved for an invasive pressure tracing c. The waveform selections are based on monitor options, ECG lead set, and the parameters that have
been enabled/disabled in the Setup Parameters dialogue.
4. Choose the desired waveform position.
5. Select the arrow to display the drop down list box of available waveform choices.
6. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
To select a waveform size for display on the main screen:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Waveforms button to access the Setup Waveform Area dialogue.
3. Locate the Size label nex t to the parameter requiring adjustment.
4. Select the arrow to display the drop down list box of available waveform size choices. a. The choices available are based on the specific waveform parameter. b. Select the desired waveform size.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
To select the sweep speed for waveforms displayed on the main screen:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Waveforms button to access the Setup Waveform Area dialogue.
3. Locate the Sweep Speed label.
4. Select the arrow to display the drop down list box (Choices include 6.25 mm/s, 12 mm/s, and 25 mm/s).
5. Select the sweep speed desired.
6. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
Page 47
DEVICE SETUP
41
To enable/disable overlap invasive pressure waveforms:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Waveforms button to access the Setup Waveform Area dialogue.
3. Locate the Overlap Invasive Pressure label: a. Select Yes to overlap all available invasive pressure. b. The invasive pressures will occupy the space of four waveform slots. c. The overlapped invasive pressure have independent waveform sizes. d. Select No to keep the invasive pressure waveforms in separate waveform parameter tiles.
4. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Recorder

The Surveyor S12 and S19 patient monitors may have a two-channel thermal bedside recorder as a purchasable option. The Recorder dialogue provides configuration for which two waveforms print, the length of the recording strip, and the recording delay.

Example Setup Recorder Dialogue

To select the two waveforms to print on the bedside recorder (optional):
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Recorder button to access the Setup Recorder dialogue.
3. Locate the Waveform 1 (prints in top waveform position of the thermal recorder printout) label.
4. Locate the Waveform 2 (prints in the bottom waveform position of the thermal recorder printout) label.
5. Select the arrow to display the drop down list box (Choices are dependent upon monitor configurations).
6. Select the waveform desired.
7. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
To select the recording length to print on the bedside recorder (optional):
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Recorder button to access the Setup Recorder dialogue.
3. Locate the Recording Time label.
4. Select the arrow to display the drop down list box (Choices are 5 seconds, 10 seconds, and 16 seconds).
5. Select the recording time desired.
6. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
Page 48
DEVICE SETUP
42
To select the recording delay for the bedside recorder (optional):
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Recorder button to access the Setup Recorder dialogue.
3. Locate the Recording Delay label.
4. Select the arrow to display the drop down list box (Choices are 0 seconds, 6 seconds, and 10 seconds).
5. Select the recording delay desired.
6. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Arrhythmia

Setup Arrhythmia Dialogue

To adjust Arrhythmia alarm settings:
1. Select the Setup quick action key on the main screen.
2. Select the Arrhythmia button in the Setup menu.
3. Adjust the Arrhythmia alarm settings as desired.
a. To adjust the Alarm Level:
Locate the Alarm Level button.
Select the arrow to display the drop down list box with choices.
Select the appropriate choice.
b. To adjust the Print on Alarm:
Locate the Print On Alarm button.
Select Yes to enable the Print On Alarm.
c. Select No to disable the Print On Alarm.
4. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
VFib, Asystole and VTach may not be turned off in this dialogue, are only available as high level alarms, and are labeled as LETHAL.
Page 49
DEVICE SETUP
43
To disable all the non-lethal arrhy thmias with one action:
1. Select the Setup quick action key on the main screen.
2. Select the Arrhythmia button in the Setup menu.
3. Select the Arrhythmia OFF button.
4. This action disables all the non-lethal arrhythmia alarms.
5. To re-enable a non-lethal arrhythmia, select the individual non-lethal arrhythmia and configure.

Alarm Suspend

The ability to suspend all alarms is a configurable feature determined by the system administration and is protected behind a password in the Administration Setup Alarms dialogue. Contact the system administrator for further details.
WARNING: IF this feature is enabled, suspending all alarms suspends ALL alarm conditions
including the lethal arrhythmias (VFib, VTach, and Asystole). Use this feature with extreme caution as
alarm checking is suspended for all alarm conditions including the lethal arrhythmi as (VFib, VTach, and Asystole). Patients must be closely observed if all alarms are suspended.
NOTE: Follow hospital standard of care for the use of this feature. This feature is only intended to be used during end of life situations and only based on the hospital standard of care.
NOTE: This feature can be enabled/disable by the system administrator.
When this feature is enabled, during an Alarm Suspend mode, an Alarm Suspend message appears in the messaging area of the main screen. Once the Alarm Suspend period ends the audio and visual alarm notifications automatically resume.
When this feature is enabled, to enter the All Alarms Suspended Mode and suspend all alarm notifications (including VFib, Vtach, and Asystole):
1. Select the Setup quick action key on the main screen.
2. Select the Alarm Suspend button in the Setup menu.
This displays the “Alarms Suspended” message in the message area on the main screen.
ALL alarms are now suspended including the lethal arrhythmias (VFib, Vtach, and Asystole).
3. Select the Close button to close the Setup menu.
When this feature is enabled, to exit the All Alarms Suspended Mode and resume alarm notifications:
1. Select the Setup quick action key on the main screen.
2. Select the Alarm Resume button in the Setup menu.
This removes the “Alarms Suspended” message in the message area on the main screen.
All configured alarms are now active.
3. Select the Close button to close the Setup menu.

Alarms

The Setup Alarms dialogue is where the clinician can make changes to several parameters are one time as opposed to making changes through each individual numeric parameter’s tile. The Alarm section is pass code protected. The Pass code is:
Dial 1
49
Dial 2
48
Dial 3
46
Page 50
DEVICE SETUP
44

Example Setup Alarms Dialogue

To adjust numeric parameter alarm settings:
1. Select the Setup quick action key on the main screen.
2. Select the Alarms button in the Setup menu.
3. Locate the numeric parameter to adjust. Select the Next Page button to scroll to see more numeric parameters (based on monitor configuration).
4. Adjust the numeric alarm settings as desired. a. To adjust the Lower and High alarm limits:
Adjust the Lower alarm limit by selecting the up/down arrows to move the lower alarm limit box until the desired value is reached.
Adjust the Upper alarm limit by selecting the up/down arrows to move the upper alarm limit box until the desired value is reached.
b. To Auto adjust the alarm limit values:
Select the Auto button.
c. To adjust the Alarm On/Off:
Select Yes to enable that parameters alarms.
Select No to disable that parameters alarms.
The Alarm Off icon displays in that numeric parameter tile.
WARNING: Disabling the parameters’ alarm limits means that NO low or high alarm
conditions for that parameter will produce alarm notifications. Use this feature with extreme caution.
NOTE: The Lower Limit and Higher Limit windows in this dialogue may contain limit values but these alarms ARE disabled if that numeric parameters Alarms on button is set to NO.
d. To adjust the Print on Alarm:
Locate the Print On Alarm button.
Select Yes to enable the Print On Alarm.
Select No to disable the Print On Alarm.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
Page 51
DEVICE SETUP
45

Audio

The Setup Audio dialogue is where the speaker volume and the HR/PR tone volume are configured. This area is also where the HR/PR systole beep tone can be enabled and disabled.

Example Setup Audio Dialogue

To adjust the speaker volume:
1. Select the Setup quick action key on the main screen.
2. Select the Audio button in the Setup menu.
3. Locate the Speaker Volume label.
4. The Speaker Volume choices are 1 to 10 in increments of 1. a. Select the Up arrow to increase the speaker volume. b. Select the Down arrow to lower the speaker volume. c. As the volume is adjusted, an audible tone is played to indicate the volume of the speaker.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
To adjust the HR/PR systole beep tone volume:
1. Select the Setup quick action key on the main screen.
2. Select the Audio button in the Setup menu.
3. Locate the HR/PR Tone Volume label.
4. The HR/PR Tone Volume choices are 1 to 10 in increments of1. a. Select the Up arrow to increase the HR/PR systole beep volume. b. Select the Down arrow to lower the HR/PR systole beep volume. c. As the volume is adjusted, an audible tone is played to indicate the volume of the HR/PR systole beep.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
To enable/disable the HR/PR systole beep tone:
1. Select the Setup quick action key on the main screen.
2. Select the Audio button in the Setup menu.
3. Locate the HR/PR Tone label. a. Select Yes to enable the HR/PR systole beep tone. b. Select No to disable the HR/PR systole beep tone.
4. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
Page 52
DEVICE SETUP
46

Restore Departmental Defaults

Restore Departmental Defaults

To restore the patient monitor back to the departmental default configuration:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Restore Departmental Defaults button.
3. Select the OK button to enter OR select the Cancel button to cancel the changes.

Administration

The Administration dialogue contains service and configuration related functions. The functions located on the left of this dialogue do not require a password. The functions located on the right of this dialogue are password­protected. Contact the system administration for further details.

Example Administration Dialogue

Page 53
DEVICE SETUP
47

Configuration

Selecting this item displays the setup of this Surveyor including its serial number, Ethernet MAC address, internal software version as well as those of accessories and modules integrated with this system. There are no configuration options here but this information is helpful for service personnel when analyzing the system for issues.

Example Setup Configuration Dialogue

Communications

Use this dialogue to configure the communication parameters of the Surveyor including the Bed ID, Unit ID as well as the network parameters for both the Surveyor Central and this Surveyor patient monitor. This information is typically defined by authorized installation and service personnel. The communications are pass code protected. The pass code is:
Dial 1
53
Dial 2
51
Dial 3
54
Specific configuration parameters include:
Bed ID and Unit ID for interfacing with Surveyor Central.
TCP/IP network parameters including host name, IP address, and port number for Surveyor Central.
Whether dynamic host control protocol (DHCP) is utilized by the Surveyor to obtain IP address information for the bedside monitor. If not, the user can define specific static IP addresses including IP address, subnet mask, gateway address and Domain Name System (DNS) address information.

Example Setup Communications Dialogue

Page 54
DEVICE SETUP
48

Screen Cleaning

Based on the clinician’s discretion, the bedside monitors touch screen may require occasional cleaning. The touch screen may be cleaned with a soft, lint-free cloth and a non-abrasive, gentle cleaner such as plain soap and water. Avoid spraying cleaning agents directly onto the monitor’s touch screen. Spray the cleaning agent onto the lint-free cloth first and then wipe the touch screen. Do not use any cleaning agents that may leave a film.
To clean the touch screen:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Screen Cleaning button.
4. The “Screen Cleaning Mode” message displays in the alarm messaging area of the main screen.
5. During this 15 seconds, patient monitoring and alarm notifications continue.
6. After the 15 seconds has expired, the touch screen activates.

Administration Setup Alarms Dialogue

The Administration Setup Alarms dialogue is a pass code protected feature. The pass code is:
Dial 1
49
Dial 2
48
Dial 3
46.

Administration Setup Alarms Dialogue

Page 55
DEVICE SETUP
49

Alarm Silence Time This setting controls the length of silence time for the Alarm Silence quick action key on the main screen. To select the Alarm Silence Time:

1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Alarms button to access the Administration: Setup Alarms dialogue.
4. Locate the Alarm Silence Time label.
5. Select the arrow to display the drop down list box (Choices are 1 minute, 1.5 minutes, 2 minutes, 5 minutes and 10 minutes).
6. Select the alarm silence time desired.
7. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Alarm Suspend Time This setting controls the length of silence time for the Alarm Suspend function.

To select the Alarm Suspend Time:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Alarms button to access the Administration: Setup Alarms dialogue.
4. Locate the Alarm Suspend Time label.
5. Select the arrow to display the drop down list box (Choices are 1 minute, 1.5 minutes, 2 minutes, 5 minutes and 10 minutes).
6. Select the alarm silence time desired.
7. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Can Suspend All Alarms This setting controls if the clinician has the ability to suspend all alarms including the lethal arrhythmias (Asystole, VTach, and VFib).

To configure:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Alarms button to access the Administration: Setup Alarms dialogue.
4. Locate the Can Suspend All Alarms label. a. Selecting Enabled means the clinician can suspend all alarms including the lethal arrhythmias. b. Selecting Disabled means the clinician cannot disable all alarms. If this choice is selected, the
Suspend All Alarms button will be hidden from the Setup dialogue.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Can Disable HR/PR Alarms This setting controls if the clinician has the ability to disable the HR/PR alarms.

To configure:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Alarms button to access the Administration: Setup Alarms dialogue.
4. Locate the Can Disable HR/PR Alarms label.
a. Selecting Enabled means the clinician can disable the HR/PR alarms. b. Selecting Disabled means the clinician cannot disable the HR/PR alarms.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
Page 56
DEVICE SETUP
50

Alarm Delay This setting determines if the monitor uses a delay before providing alarm notifications. This feature is intended to reduce erroneous alarm notifications.

To configure:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Alarms button to access the Administration: Setup Alarms dialogue.
4. Locate the Alarm Delay label. a. Select Yes to enable the alarm delay. b. Select No to disable the alarm delay.
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.
If enabled, the alarm delay values are based on the specific parameter and as follows:
Parameter
Lower limit violation delay
Upper limit violation delay
HR, PR (from SpO2), PR (from IBP)
3 seconds
3 seconds
RR
5 seconds
5 seconds
Mortara SpO2, Nellcor SpO2 (SatSeconds disabled)
10 seconds
10 seconds
IPI
10 seconds
0 seconds
Nellcor SpO2(SatSeconds enabled), all other parameters
0
0

Second Speaker Time (Minutes) The Surveyor has a second speaker that provides additional audible notification when the initial audible alarm is not acknowledged and silenced. The second speaker begins sounding approximately 1 second after a pre-defined amount of time has passed if the initial alarm sound has not been silenced.

To configure the second speaker alarm time:
1. Select the Setup quick action key on the main screen to access the Setup dialogue.
2. Select the Administration button.
3. Select the Alarms button to access the Administration: Setup Alarms dialogue.
4. Locate the Second Speaker Time (Minutes) label.
Select the Up/Down arrow to rotate through the choices (Choices include 0 minutes, 1 minute, 2 minutes, and 3 minutes).
5. Select the OK button to enter that change OR select the Cancel button to cancel the changes.

Administration Setup System Dialogue

The System dialogue is a password protected area intended for use by service and system administrative personnel only. The Setup System dialogue is where the units of measure are configured for height, weight, and temperature. This dialogue is also used to configure the print location, set the date and time, and to save departmental default settings. Contact service or system administrator for further details.
Page 57
51
The following table lists specific reports and where they may be printed based on system configuration.
Recording type
Prints at
Strip chart (initiated by pressing the Print soft key on monitor)
Print location setting (Bedside, Central, or both)
12 lead report
Print location setting (Bedside, Central, or both)
Alarm report
Print location setting (Bedside, Central, or both)
Trend report
Bedside
ST averages
Bedside

Administration Setup Se rvice Dialogue

The Service dialogue is a password protected area intended for use by service and system administrative personnel only. The Setup Service dialogue is where the demonstration mode for simulated data on the patient monitor is enabled and disabled. This dialogue is also where the monitor settings can be transferred to and from a USB thumb stick when configuring multiple monitors. The monitor can be returned to the factory default configuration settings in this dialogue. Restore the factory defaults to the unit by tapping the “Setup” icon, select Administration, select “service enter the passwords, Dial 1 = 53, Dial 2 = 51, Dial 3 =54. Press “OK”, tap the ‘Restore Factory Defaults” icon and press “Ok”. You will see an on screen message that says “Please restart monitor for changes to take effect”. Power cycle the unit, and start a monitoring session with a new patient. If required, refer to S12/S19 User Manual, 9515-183-50-xxx for that process.

Administration Setup Factory Dialogue

The Factory dialogue is a password protected area intended for use by service and administrative personnel only. Contact service or system administrator for further details.
Page 58
52

9. UNIT DISSASSEMBLY

S12 and S19 Patient Monitors

Unit disassembly and repair activities are to be performed by Authorized Mortara Service Representatives.
Page 59
UNIT DISASSEMBLY
53

S12 Monitor

Mechanical Overview
Page 60
UNIT DISASSEMBLY
54

S19 Monitor

Mechanical Overview
Page 61
UNIT DISASSEMBLY
55

Battery Removal & Replacement

1. Dismount the unit and remove any mounting assembly on the unit.
2. Locate the 4 screws (item 11) that retain the battery door (Item 45) and remove them.
S19 picture above, the location of the screws on the S12 are identical.
3. Remove the battery door (Item 45) to access the battery (Item 7)
4. Turn the unit over to allow gravity releases the battery from the unit.
5. Install the battery in reverse order.
Page 62
UNIT DISASSEMBLY
56

Rear Housing Removal & Replacement

1. Dismount the unit and remove any mounting assembly attached to the device.
2. Lay the unit face down on a flat surface with the top of the unit facing you (S19 shown).
3. Remove the battery (see Battery Removal and Replacement).
4. Locate the eight (8) mounting screws (Item 11) for the Rear Housing and remove them.
(S19 shown locations are identical for the S12)
5. Once the screws are removed, carefully lift the Rear Housing assembly straight up approx 3 to 4 inches (7 to 10cm).
Page 63
UNIT DISASSEMBLY
57
6. Locate the 4 wire cable to the Beacon board (closest cable to top of the unit, Item 36) and remove the cable from the connection to the main board.
7. Once the Beacon Board cable is disconnected from the main board, the Rear Housing can be raised for easier access to the remaining cables.
Note: For the S12 monitor the Beacon Board and cable will now be loose and can be removed from the LCD housing.
Page 64
UNIT DISASSEMBLY
58
8. Remove the remaining cables form the circuit boards, noting the cable size and location.
S19 Cable Connections
S12 Cable Connections

Table of Cable Connections

Unit
Cable
Board Connection
Item #
S12 & S19
Main LCD (large Cable)
Processor/Bitsy board connector JJ8
46
S12& S19
Beacon Board Cable
Main Board – J27
36
S12 & S19
Copper colored Touch Pad Cable
Main Board J46
S12 & S19
Green colored Touch Pad cable
Main Board – J46
S19
Small LCD cable (5 conductor cable)
Main Board J35
S19
Large LCD cable (10 conductor cable)
Main Board J18
S12
Large LCD cable (10 conductor cable)
Main Board J25
Page 65
UNIT DISASSEMBLY
59

Processor Board Removal & Replacement

1. With the battery and the Rear Housing removed locate the 2 nuts (Item 44) retaining the processor board (Item 41) to the Main Board and remove them.
NOTE: Earlier models used item 41a (S12/S19), later models used a Gen2 board 41b (S12) or 41c (S19). Refer to the item identification table for correct part number information.
2. Lift gently straight up on both ends of the processor board (Item 41) as shown to remove the PCA from the two connector sockets on either end of the board.
3. Reassemble in reverse order
Page 66
UNIT DISASSEMBLY
60

Main Board Removal & Replacement

If the main PCBA requires replacement, the conformance testing section will need to be performed. In addition, the unit serial number will need to be entered into system memory by navigating to the following password protected factory menu screen: Setup, Administration, Factory.
1. Locate the three (3) mounting screws and remove them. Item #10 for the two screws shown on the left and one item #9 screw shown on the right.
2. Gently lift up on the NIBP nozzle (item 34) to lift the board out of the Rear Housing
Page 67
UNIT DISASSEMBLY
61
3. Carefully lift the main board out of the Rear Housing, there will be at least 2 cables that will need to be removed, the Battery Interconnect Cable (Item 4) and the Speaker Cable (Item 1).
4. Reach between the Rear Housing and the Main board and remove the Battery Interconnect Cable (Item 4) and Speaker Cables (Item 1).
NOTE: Earlier models used item 2a (GEN 1), later models used a Gen2 board item 2b. Refer to the item identification table for correct part number information.
Note - There may be other cables connected to the Main Board (based on the optional equipment) before it can be removed from the Rear Housing.
5. Reassemble in reverse order
CAUTION: Ensure the hoses are not pinched during reassembly of the unit.
Page 68
UNIT DISASSEMBLY
62
Page 69
UNIT DISASSEMBLY
63

LCD Removal & Replacement S12

Please note that the LCD and front bezel for the S12 comes as a complete assembly (Item 23). If the LCD requires replacement Mortara recommends replacing the entire assembly. If the LCD is OK, but the touch screen or bezel require replacement, Mortara recommends replacing the Bezel/Touchscreen assembly (Item 25).
1. Remove the Rear Housing from the unit.
2. Locate the 4 screws holding the LCD to the front bezel and remove them.
3. Lift the LCD out of the Front bezel
Page 70
UNIT DISASSEMBLY
64

LCD Removal & Replacement S19

Please note that the LCD and front bezel for the S19 comes as a complete assembly (Item 24). If the LCD requires replacement Mortara recommends replacing the entire assembly. If the LCD is OK, but the touch screen or bezel require replacement, Mortara recommends replacing the Bezel/Touchscreen assembly (Item 26).
1. Remove the Rear Housing from the unit.
2. Locate the 13 screws (Item 11) holding the Back LCD Bezel (Item 42) and remove them.
3. Lift the Back Bezel off the LCD assembly (no cables are attached)
Page 71
UNIT DISASSEMBLY
65
4. Locate the 4 screws that hold the LCD to the front LCD Bezel.
5. Lift the LCD out of the Front bezel
6. Reassemble in reverse order
Ensure that the cables do not get pinched when reassembling.
Page 72
UNIT DISASSEMBLY
66

Removal and Replacement of the Optional Thermal Writer (S12 ONLY)

The S12 has an optional single channel thermal writer (Bedside Recorder, Item 8). S12 monitors with this option have a different Rear Housing however removal of the Rear Housing removal procedure is identical.
1. Open the writer door by sliding down the latch release button.
Page 73
UNIT DISASSEMBLY
67
2. Remove the paper roll from the writer assembly.
3. Locate the mounting screws for the writer.
Note: These screws are captive screws and they will remain attached to the writer assembly.
Page 74
UNIT DISASSEMBLY
68
1. Slide the writer (Item 8) out of the Rear Housing being carful of the attached data cable.
2. Follow the writer data cable into the unit to reach the snap in RJ45 connector. Remove the cable from the Main Board by unlatching the cable form the connector.
3. Reinstall the writer (Item 8) in the reverse order.
Note: The writer can also be removed by removing the Rear Housing and the main board. This method allows for easier access to the cable.
Page 75
UNIT DISASSEMBLY
69

Optional Thermal Writer for the S19

The optional thermal writer for the S19 monitor comes as a completed assembly (Item 43). Service parts for this item are not sold separately.
Page 76
UNIT DISASSEMBLY
70
The items listed in the S12/S19 Item Identification Table identify the serviceable level of the device.
Subcomponents of assemblies listed are not available as individual service items from Mortara, the assembly level item must be used for servicing purposes.
S12/S19 Item Identification Table
Item #
Part #
Description
Item
1
25020-053-53
SPEAKER LEADS & CONNECTOR ASSY
2a
SERV-26025­115-150
SERV-26025­115-151
SERV-26025­115-152
SERV-26025­115-153
SERV-26025­115-160
SERV-26025­115-161
SERV-26025­115-162
SERV-26025­115-163
SURVEYOR SpO2, 4IBP+CO, GEN 1, S12 PRINTER CONN
SURVEYOR SpO2, 4 IBP+CO, GEN1, S19 PRINTER CONN
SURVEYOR SpO2, 4IBP+No CO, GEN 1, S12 PRINTER CONN
SURVEYOR SpO2, 4 IBP+No CO, GEN 1, S19 PRINTER CONN
OEM SpO2, 4 IBP+CO, GEN 1, S12 PRINTER CONN
OEM SpO2, 4 IBP+CO, GEN 1, S19 PRINTER CONN
OEM SpO2, 4 IBP+No CO, GEN 1, S12 PRINTER CONN
OEM SpO2, 4 IBP+No CO, GEN 1, S19 PRINTER CONN
(26025-115-61 pictured)
Page 77
UNIT DISASSEMBLY
71
2b
36025-155-150
36025-155-151
36025-155-152
36025-155-153
36025-155-160
36025-155-161
36025-155-162
36025-155-163
SURVEYOR SpO2, 4IBP+CO, GEN 2, S12 PRINTER CONN
SURVEYOR SpO2, 4 IBP+CO, GEN 2, S19 PRINTER CONN
SURVEYOR SpO2, 4IBP+No CO, GEN 2, S12 PRINTER CONN
SURVEYOR SpO2, 4 IBP+No CO, GEN 2, S19 PRINTER CONN
OEM SpO2, 4 IBP+CO, GEN 2, S12 PRINTER CONN
OEM SpO2, 4 IBP+CO, GEN 2, S19 PRINTER CONN
OEM SpO2, 4 IBP+No CO, GEN 2, S12 PRINTER CONN
OEM SpO2, 4 IBP+No CO, S19, Gen 2, PRINTER CONN
(36025-155-152 pictured)
3
26025-116-151
BEACON BOARD PCB ASSY S12/S19
Page 78
UNIT DISASSEMBLY
72
S12/S19 Item Identification Table
Item #
Part #
Description
Item
4
26025-118-50
PCB ASSY BATTERY CONNECTOR & CABLE
5
3181-008
POWER CORD US/CAN HOSPITAL 5-15P+320-C13
6
4101-012
POWER SUPPLY 100-240VAC 15VDC 40W
7
4800-017
BATTERY RECHARGEABLE LITHIUM ION
8
5450-006-50
THERMAL PRINTER 50mm ROLL SERV PART 183-
01
S12/S19 PLATEN ROLLER ASSEMBLY (For use in 5450-006-50)
Page 79
UNIT DISASSEMBLY
73
S12/S19 Item Identification Table
Item #
Part #
Description
Item
9
6020-060
SCREW THD-FORM PAN HD TORX 4-20x1/4"
10
6020-065
SCREW THD-FORM PAN HD TORX 4-20x5/16"
11
6020-836
SCREW PAN HD TORX M3x8 SS
12
6140-006
E-RING 4mm ID
13
6140-007
C-RING 5mm ID
14
6160-009
STANDOFF NYLON HEX 6MM W/ 3MM TAP THRU
15
6320-006
FOOT PAD 2.5 X 0.30 X 0.125 THK BLACK
16
6320-007
FOOT PAD 4.25 X 0.30 X 0.125 THK BLACK
17
6901-016-01
MODULE CO2 ORIDION MICROMEDI
Page 80
UNIT DISASSEMBLY
74
S12/S19 Item Identification Table
Item #
Part #
Description
Item
18
6901-017-01
MODULE SpO2 EXT CABLE SENSOR NELLCOR
(Front)
(Back)
19
6901-019
FITTING PANEL MNT CONN NYLON 3/32"&1/16" (CO2 EXHAUST FITTING)
20
8363-033-50
PAD PROCESSOR BD SUPPORT
21
8363-001-50
HOUSING REAR S12 W/RECORDER
Page 81
75
S12/S19 Item Identification Table
Item #
Part #
Description
Item
22
8363-002-50
HOUSING REAR SURVEYOR S12 / S19
23
8363-003-53
BEZEL S12 FINAL ASSY W/ LCD AND TOUCH
24
8363-004-53
BEZEL S19 FINAL ASSY W/ LCD AND TOUCH
25
8363-003-52
BEZEL S12 WITH TOUCH SCREEN ASSY
26
8363-004-52
BEZEL S19 WITH TOUCH SCREEN ASSY
27
N/A
28
8363-011-50
BATTERY CONN RETAINER S12 / S19
Page 82
76
S12/S19 Item Identification Table
Item #
Part #
Description
Item
29
8363-013-50
RETAINER CONN S12 / S19
30
8363-016-50
BRACKET RECORDER MTG S12 INTERNAL
31
8363-017-50
SPRING INPUT PANEL SPRING RETAINER ORIDION INLET
32
8363-018-50
DOOR ETCO2 SURVEYOR S12 / S19
33
8363-024-50
WASHER SPEAKER MOUNT
34
8363-025-50
COUPLER NIBP SLIP-IN
35
8363-028-50
CABLE ASSY MICROMEDI ETCO2
36
8363-034-50
CABLE ASSY BEACON BOARD S12/S19
Page 83
77
S12/S19 Item Identification Table
Item #
Part #
Descripti
Item
37
9042-080-03
LABEL NELLCOR OXIMAX
38
9050-090-01
LABEL NAMEPLATE SURV S12 PATIENT MONITOR
39
9050-090-02
LABEL NAMEPLATE SURV S19 PATIENT MONITOR
41a
41b
41c
SERV-9960-
066-03
413350
413351
PROCESSOR BOARD S12/S19 (Bitzy Board)
G2 Processor Board S12 (Tested)
G2 Processor Board S19 (Tested)
Page 84
78
42
8363-005-50
REAR COVER BEZEL S19
Page 85
79
S12/S19 Item Identification Table
Item #
Part #
Description
Item
43
5450-007-50
External Writer Kit S19 SERV PART 183-
01
S12/S19 PLATEN ROLLER ASSEMBLY (For use in 5450-007-50)
44
6150-003
NUT M3
45
8363-038-50
COVER BATTERY S12 / S19
46
25020-085-50
VIDEO CABLE
47
25020-084-50
BACKLIGHT CABLE
48
8363-029-50
MANIFOLD ASSEMBLY NIBP
Page 86
80
S12/S19 Item Identification Table
Item #
Part #
Description
Item
49
9042-080-01
LABEL MORTARA SpO2
50
9042-080-03
LABEL NELLCOR OXIMAX
51
6301-001
MUFFLER-FILTER NIBP PUMP INTAKE
52
8363-027-50
PUMP & WIRE ASSY
53
7495-018
CABLE TIE 8”
54
8363-026-50
VALVE ASSEMBLY .050 IN ORIFICE
55
7400-022
TAPE KAPTON DISC 3/8" DIA (used to hold SD card)
56
8363-030-50
BATTERY CABLE ASSY
Page 87
81
S12/S19 Item Identification Table
Item #
Part #
Description
Item
57
8363-007-50
8363-008-50
8363-009-50
8363-010-50
INPUT PANEL w-etCO2 Printed, 4p CO
INPUT PANEL w-etCO2 Printed, 2p no CO
INPUT PANEL wo-etCO2 Printed, 4p CO
INPUT PANEL wo-etCO2 Printed, 2p no CO
8363-009-50 shown as example
Page 88
82

10. CONFORMANCE TESTING

Conformance Testing
Conformance testing is to be performed by Authorized Mortara Service Representatives to verify the device is functioning correctly after repair operations have been performed. Testing results should be documented on the test data record at the end of this section of the manual.

Required Equipment:

Qty
Part Number
Description
1
EL400 or equivalent
Vital Sign Simulator
1
N/A
NIBP Cuff
1
EL275
DMM
1
N/A
Power Driver 3.5 inch-pounds
1
N/A
Power Driver 5.0 inch-pounds
1
N/A
Nut Driver (7/32)
1
9293-052-50
CO2 Test Cable Filter Line Set
1
9293-050-60
5 Lead ECG Cable
1
9293-057-60
Finger Clip SpO2 Sensor (Mortara SpO2)
1
9293-057-51
Cable SpO2 Adaptor & Extension
1
6901-017-03
Finger Clip SpO2 Sensor Nellcor (SpO2)
1
6901-017-02
Cable SpO2 Adaptor & Extension Nellcor
1
TF-0567
AM12M Acquisition Module
2
TF-0560
IBP Test Cable
1
TF-0561
Temperature Test Cable
1
TF-0562
Cardiac Output Test Cable
1
TF-0563
USB Production Dongle
1
TF-0564
USB Test Harness Drive
1
TF-0565
Nurse Call Fixture
1
TF-0568
S12/S19 Power Test Fixture
2
N/A
Shorting Bar (applied parts)
Required to perform NIBP calibration (not required to perform preventive maintenance or conformance testing).
Qty
Part Number
Description
1
6901-011
Hose fitting
1
6901-022-01
Extension hose
1
N/A
Hand pump
1
TF0419
Alloy NIBP Rigid Vessel
1
N/A
Pressure measurement device
Page 89
CONFORMANCE TESTING
83

1.0 Power Testing

1.1
Unscrew the battery cover from the UUT and remove the lithium ion battery.
1.2
Connect TF-0568 to the battery terminals of the UUT, with a current meter in series to measure current flow.
1.3
Insert the battery removed from the monitor into TF-0568.
1.4
With the monitor in the off state, the current draw (off current) should read < 350uA. Record the test result.
1.5
Configure the current meter to the 10A range and press the on” button on the monitor to power up the device.
1.6
Once the monitor powers up and enters the main screen, the current draw (on current) should read as follows (depending on the model). Record the test result.
S12 Patient Monitor <1.6A S19 Patient Monitor <2.3A
1.7
Verify the battery icon appears in the lower right section of the monitor.
1.8
Connect the external power supply (15 VDC) to the DC power input located on the right side of the monitor. The current flow should reverse polarity and begin to charge the battery at a rate of 2000mA or less (depending on the condition of the battery).
The charging current will be less when the monitor is in the on state versus the off state, particularly for the S19 model.
1.9
Verify the AC Power LED, located in the lower left corner of the monitor is illuminated.

2.0 Functional Testing

2.1 Touch Screen calibration

2.1.1 Insert TF-0564 USB Test Harness Drive into the USB patient connector port of the UUT as
shown below:
Page 90
CONFORMANCE TESTING
84
2.1.2 Plug in the Power Cord into the back of the UUT and then press the Power button to power up
the UUT as shown below:
2.1.3 In the UUT screen select “Recalibrate Touch Panel”.
2.1.4 Use a pen to touch the intersection of the two lines in the middle of the screen.
NOTE: The software will move the lines to a new location.
Page 91
CONFORMANCE TESTING
85
2.1.5 In the UUT select the “Save Touch Panel Cal” button after the touch screen calibration is
complete as shown below:

2.2 Monitor Brightness Adjustment Check

2.2.1 On the UUT display, tap the “Dimmer Display” button to verify the screen changes
accordingly.
2.2.2 On the UUT display, tap the “Brighter Display” button to verify the screen changes
accordingly.
Page 92
CONFORMANCE TESTING
86
2.2.3 On the UUT press and hold the power button to turn off the UUT.
2.2.4 On the UUT, remove TF-0564 USB test drive.
Page 93
CONFORMANCE TESTING
87

2.3 Speaker Volume and Date/Time Verify

2.3.1 Insert TF-0563 USB Production Dongle.
2.3.2 Power on UUT by pressing the power button.
2.3.3 Select “No” to the New Patient screen when UUT powers on.
2.3.4 Perform Audio Check.
Page 94
CONFORMANCE TESTING
88
Select "Setup” button from lower right of the UUT. Select “Audio”. Run a speaker volume and HR/ PR Tone volume check: pressing the Up/Down arrows while verifying the
volume increases as the numbers get higher, and decreases as the numbers get smaller (1-9). Then Press "OK” Button. (See Setup Audio Below).
2.3.5 Date/Time Verify From UUT setup screen, select Administration>System>Set Date & Time. Verify date and
time settings, adjust to current date and time if necessary. Then press “OK” twice to return to the main screen.

2.4 Ethernet Connectivity Check

2.4.1 Connect the LAN Cable into the Ethernet Port in the back of the UUT. Make sure the cable
clicks into place.
2.4.2 Verify the Yellow and Green LEDs are ON at the LAN connector.
Page 95
CONFORMANCE TESTING
89
2.4.3 On the UUT go to Setup>Administration>Communications to open the “Communications” menu and change the Use DHCP box to “Yes”. Then press “OK”. The UUT will reboot.
2.4.4 On the UUT go to Setup>Administration>Communications to open the Communications” menu. Verify the Ethernet connection IP Address has been populated with an IP address other than 0.0.0.0. Press “Cancel” and reopen the Communications menu if the IP address does not populate right away.
2.4.5 After the Ethernet connection is verified, set the Use DHCP box to “NO”. Then press “OK”. The UUT will reboot.
2.4.6 Disconnect the LAN cable.

2.5 Thermal Writer Check

2.5.1 Verify paper is installed in the thermal writer.
2.5.2 Select the “Print” icon from the Main Screen to print a test strip.
Page 96
CONFORMANCE TESTING
90
2.5.3 Verify a full test strip prints including: a patient information section, strip chart report section, and parameter snapshot section.

2.6 Nurse Call Functional Check

2.6.1 Insert TF-0565 nurse call test fixture into the right side panel of the UUT next to the Bell Icon.
2.6.2 Open the Recorder Door and verify the door open alarm sounds.
2.6.3 Verify a Blue Alarm Light on top of the UUT and an audible tone.
2.6.4 Verify the LED of the Nurse Call Fixture illuminates in the same manner as the alarm light.
2.6.5 Verify the error message “Recorder Door is Open” appears on the bottom of the Main Screen.
2.6.6 Close the Recorder Door, the alarming should stop and the alarm light should also turn off. Remove TF-0565 from the UUT.
Page 97
CONFORMANCE TESTING
91

2.7 NIBP Testing

NOTE: Do not allow system to remain pressurized and stable below 20 mmHg. The monitor will remove this pressure as a zero offset and this will affect the validity of the calibration check.
NOTE: The following are required to perform this test: NIBP simulator or sphygmomanometer along with a Y-cable and an NIBP cuff.
Pressure Accuracy Test: Via the Service settings, put the NIBP in to calibration mode. Set the pressure to 25mmHg and 225 mmHg respectively and verify that the pressure values reported by the Surveyor patient monitor matches ((±2 mmHg) of that reported on the simulator or sphygmomanometer. Release pressure.
Measurement Accuracy Test: Connect to Patient Simulator and take a NIBP measurement. Verify proper NIBP value at 120/80 (+/- 5 mmHg).
Leak Test: Inflate a cuff to 150-170 mmHg. Allow cuff pressure to settle (thermal effect). Verify that the pressure (once stable) drops less than 4 mmHg in 1 minute. Verify that the pressure is automatically discharged through the overpressure valve 150 seconds +/- 5 seconds after the pressure exceeds 15mmHg.
Overpressure Test: Power cycle the UUT and put the NIBP in to calibration mode. Inflate cuff to 300 mmHg. Verify that the pressure is automatically discharged through the overpressure valve at 300 +/- 30 mmHg.
Set the NIBP back to normal mode. Power cycle the monitor.
NIBP Calibration – (ONLY PERFORMED IF NIBP OUT OF ACCEPTABLE RANGE)
Place Surveyor into Test by powering on UUT with Dongle installed in USB port.
Place Surveyor into NIBP cal mode by selecting the Stand By button on main screen.
Initial Setup:
Connect 6901-011 Hose Fittings, 6901-022-01 extension hose, hand pump, and
TF0419 ALLOY NIBP RIGID VESSEL to Pressure Standard.
Connect end of extension hose to transducer located at U44 of UUT. Turn on Pressure Standard and select F2 (units of measure).
Inflate to 250mmHg using hand pump or equivalent. Set pot R74 so NIBP cuff pressure on Surveyor display matches the pressure gauge reading. Release pressure completely so simulator display indicates zero. Re-inflate to 250mmHg and verify accuracy. Power off unit by holding down the on/off button on front of display.
If calibration was performed to restore to specification, perform all conformance tests defined above to ensure proper operation.
Page 98
CONFORMANCE TESTING
92

2.8 ECG Input Test

2.8.1 Remove the USB production dongle TF-0563 from the UUT.
2.8.2 Connect the AM12M USB cable to the UUT port. Verify the 12 patient leads are connected to the EL400 simulator.
2.8.3 From the main screen of the UUT, touch the HR menu in the upper right corner (usually displaying the heart rate reading to open the Setup HR/PR menu.
2.8.4 In the Setup HR/PR menu set the 12-Lead Enabled setting to “YES”.
Page 99
CONFORMANCE TESTING
93
2.8.5 Select “OK”.
2.8.6 From the main screen select “12 Lead ECG”.
2.8.7 Verify that all 12 ECG waveforms are displayed and show no signs of distortion.
Page 100
CONFORMANCE TESTING
94
2.8.8 Select “Close” to return to the main screen.
2.8.9 From the main screen, verify the UUT reads 60 +/- 1 bpm. Record the test result.
2.8.10 Disconnect the AM12M from the UUT and verify a Lead Off alarm sounds. Reconnect the AM12M USB to the UUT. Verify the Lead Off alarm turns off.
2.8.11 From the main screen of the UUT, touch the HR menu in the upper right corner (usually displaying the heart rate reading to open the Setup HR/PR menu.
Loading...