(267 days)
Not Found
No
The document describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No
The device is a patient monitor, which measures and displays physiological parameters. It does not actively treat or provide therapy to the patient.
Yes
The device monitors various physiological parameters such as blood pressure, respiration, temperature, SpO2, and ECG. While it doesn't provide a diagnosis itself, the monitoring of these parameters is crucial for healthcare professionals to diagnose patient conditions.
No
The device description clearly indicates it is an integrated multi-parameter patient monitor with physical components like a color touch screen display, speaker, LED alarm bar, ON/OFF switch, and internal battery. It also mentions integrated and optional printers. This is not a software-only device.
Based on the provided text, the Mortara Surveyor Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Mortara Surveyor Function: The description clearly states that the Mortara Surveyor Patient Monitor is used for monitoring physiological parameters directly from the patient. These parameters include blood pressure, respiration, temperature, SpO2, CO2, ECG, and cardiac output. These are measurements taken in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing laboratory tests.
Therefore, the Mortara Surveyor Patient Monitor is a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the monitoring of the following parameters:
- Non-invasive blood pressure
- Impedance respiration
- Invasive blood pressure
- Temperature
- Functional arterial oxygen saturation (SpO2)
- End-tidal & inspired CO2
- ECG monitoring with arrhythmia & ST-segment
- 12-Lead resting ECG
- Cardiac output
The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:
- Non-invasive blood pressure
- Impedance respiration
- Invasive blood pressure
- Temperature
- Functional arterial oxygen saturation (SpO2)
- End-tidal & inspired CO2
- ECG monitoring with arrhythmia
- 12-Lead resting ECG
The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station.
The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Product codes
MHX, DQA, DPS, MLD, DSB, MSX, DSI, DSJ
Device Description
The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations.
Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5" display and comes with an optional 2 channel printer.
The Surveyor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, noninvasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO2), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output.
The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Surveyor Network, the Surveyor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms.
The new Surveyor S12, S19, V3.0.1 has added Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, adolescents, children, infants and neonatal patient populations
Intended User / Care Setting
healthcare professionals in all areas of a healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices" and "Off-the-Shelf Software Use in Medical Devices."
S12/S19 was designed and tested for compliance with the applicable clauses of the following standards:
IEC 60601-1:2005 Ed:3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General requirements for safety - Collateral Standard: Electromagnetic Compatibility
IEC 60601-1-8:2006 Medical Electrical Equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-25 Edition 2.0 2011-10: Medical Electrical Equipment - Part 2-25: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographs
IEC 60601-2-27:2011 Ed:3 Medical Electrical Equipment PT. 2: Particular Requirements for the Safety, including essential performance, of Electrocardiographic Monitoring Equipment
IEC 60601-2-34:2011 Ed:3 Medical Electrical Equipment Part 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment
IEC 62366:2007 Medical Devices -- Application of usability engineering to medical devices
ISO 80601-2-30:2009 Ed: 1.1 Medical Electrical Equipment - Part 2-30: Particular Requirements for the Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers; Corr. 1: 2010
ISO 80601-2-55:2011 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-56:2009 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61:2011 - Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
AAMI ANSI EC 57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms
IEC 62304:2006; Medical device software -- Software life cycle processes
Conclusion: Mortara Instrument, Inc. considers the Surveyor S12 and S19 Patient Monitor performance to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
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September 4, 2018
Mortara Instrument, Inc. Manisha Gokuli Regulatory Affairs Manager 7865 North 86th Street Milwaukee, Wisconsin 53224
Re: K173765
Trade/Device Name: Surveyor Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DQA, DPS, MLD, DSB, MSX, DSI, DSJ Dated: December 7, 2017 Received: December 11, 2017
Dear Manisha Gokuli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Arielle Drummond -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are clear and easy to read, with consistent spacing between them.
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173765
Device Name
Surveyor S12 and S19 Patient Monitor
Indications for Use (Describe)
The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the monitoring of the following parameters:
-
- Non-invasive blood pressure
-
- Impedance respiration
-
- Invasive blood pressure
-
- Temperature
-
- Functional arterial oxygen saturation (SpO2)
-
- End-tidal & inspired CO2
-
- ECG monitoring with arrhythmia & ST-segment
-
- 12-Lead resting ECG
-
- Cardiac output
The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:
-
- Non-invasive blood pressure
-
- Impedance respiration
-
- Invasive blood pressure
-
- Temperature
-
- Functional arterial oxygen saturation (SpO2)
-
- End-tidal & inspired CO2
-
- ECG monitoring with arrhythmia
-
- 12-Lead resting ECG
The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station.
The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Section 5
510(k) Summary
1. Submitter
Date: 10/17/2017
Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Telephone 414-354-1600 Fax 414-354-4760
Primary Contact
Manisha Gokuli Regulatory Affairs Manager Manisha.Gokuli@mortara.com
Secondary Contact
Mark Elliott VP Global RA/QA Mark.Elliott@mortara.com
2. Product Names
Device Trade Name
Common/ Usual Name
Classification
Surveyor Patient Monitor
Patient Physiological Monitor (with Arrhythmia Detection or Alarms)
Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) 870.1025 MHX
Oximeter 870.2700 DQA
Electrocardiograph 870.2340 DPS
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Image /page/5/Picture/0 description: The image shows the text "K173765" above a blue heart shape. The heart shape is formed by two curved lines meeting at a point at the bottom and curving outwards at the top. The heart is solid blue, and the background is white. The text is in black and is located in the top left corner of the image.
Monitor, ST Segment with Alarm 870.1025 MLD
Alarm, Blood Pressure 870.1100 DSJ
Plethysmograph, Impedance 870.2770 DSB
System, Network and Communication, Physiological Monitors 870.2300 MSX
Detector and Alarm, Arrhythmia 870.1025 DSI
3. Predicate Device to which this is Substantially Equivalent
| Predicate Device | Name | 510(k) Number |
|---|---|---|
| Primary | Surveyor Patient Monitor | K161517 |
| Secondary | Philips Intelliview Patient Monitor MX800 | K161531 |
The S12/S19 was last recalled in 2014, Z-0110-2015. There are no open recalls for the S12/S19 Patient Monitor.
The Intellivue Patient Monitor Model MX800 was last recalled in July 26, 2016, Z-2328-2016.
4. Device Description
The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations.
Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED
6
Image /page/6/Picture/0 description: The image shows the text 'K173765' at the top left corner. Below the text is a blue shape that resembles a stylized heart or an 'M' shape. The heart shape is created by a white space within the blue area, giving it a cutout appearance.
alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5" display and comes with an optional 2 channel printer.
The Survevor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, noninvasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO2), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output.
The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Survevor Network, the Survevor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms.
The new Surveyor S12, S19, V3.0.1 has added Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station
| Patient Types | |||
|---|---|---|---|
| Parameters | Adult | Pediatric | |
| Adolescent/Children | Infant/Neonate | ||
| ECG 3-Lead | ✓ | ✓ | ✓ |
| ECG 5-Lead | ✓ | ✓ | ✓ |
| ECG 12-Lead | ✓ | ✓ | ✓ |
| Resting 12 Lead | |||
| Interpretation | ✓ | ✓ | ✓ |
| ST Segment Monitoring | ✓ | ✓ | N/A |
| Respiration - Impedance | ✓ | ✓ | ✓ |
| Respiration- Capnography | ✓ | ✓ | ✓ |
| NIBP (Non-Invasive Blood | |||
| Pressure) | ✓ | ✓ | ✓ |
| SpO2- Mortara | ✓ | ✓ | N/A |
| SpO2- Nellcor Oxi-Max | ✓ | ✓ | ✓ |
| CO2 | ✓ | ✓ | ✓ |
| IBP (Invasive Blood | ✓ | ✓ | ✓ |
Parameters by Patient Type
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| Pressure) | |||
|---|---|---|---|
| Cardiac Output | ✓ | ✓ | N/A |
| Temperature | ✓ | ✓ | ✓ |
| Arrhythmia Basic | ✓ | ✓ | ✓ |
| Arrhythmia Extended | ✓ | ✓ | ✓ |
5. Intended Use
Indications for Use
The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the monitoring of the following parameters:
- ✓ Non-invasive blood pressure
- ✔ Impedance respiration
- ✓ Invasive blood pressure
- ✓ Temperature
- ✔ Functional arterial oxygen saturation (SpO2)
- ✓ End-tidal & inspired CO2
- ✓ ECG monitoring with arrhythmia & ST-segment
- ✓ 12-Lead resting ECG
- ✓ Cardiac output
The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:
- V Non-invasive blood pressure
-
Impedance respiration
- Invasive blood pressure >
-
Temperature
-
Functional arterial oxygen saturation (SpO2)
- V End-tidal & inspired CO2
-
ECG monitoring with arrhythmia
- V 12-Lead resting ECG
The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station.
The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
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6. Technological characteristics
The Surveyor S12 and S19 Patient Monitor employs the same functional scientific technology as its predicate devices Surveyor S12 and S19 Patient Monitor v2.0.0 (K161517) and Philips MX800 Patient Monitor (K161531). At a high level, the devices provide continuous monitoring for ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output.
Surveyor S12 and S19 Patient Monitor v3.1.0 was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. Surveyor S12 and S19 Patient Monitor v3.1.0 is substantially equivalent to Surveyor S12 and S19 Patient Monitor v2.0.0 (Primary Predicate K161517), which is in commercial distribution, except for the following new features that were added:
- Wireless LAN capability .
- Bedside-to-Bedside (B2B) Feature: The 'Bed to Bed . communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station.
A second predicate device used for this submission is Philips MX800 Patient Monitor (K161531), and has a feature 'Bed-to-bed overview', that provides clinicians with an overview of all the patient beds in their care. This feature is similar to the 'Bedsideto-Bedside (B2B) Feature' that is in the submitted device.
A full comparison matrix of functionality is located in Section 12, Substantial Equivalence Discussion and is shown below.
Comparison Matrix
For detailed comparisons refer to the Table 12-1.
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Table 12-1 Comparison Matrix to Predicate Device
| | Predicate
Device 1
(Primary)
Surveyor
S12 and
S19
Patient
Monitor | Predicate
Device
2
(Secondary)
Philips
MX800
Patient
Monitor | Present Submission
Surveyor S12 and S19
Patient Monitor | Change
explanation
for the
subject
device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 510(k) | K161517 | K161531 | Present Submission | |
| BRAND | Surveyor
S12/S19 | Philips
MX800 | Surveyor S12/S19 | |
| COMPANY | Mortara
Instrument, Inc. | Philips
Medical
Systems | Mortara Instrument, Inc. | |
| Software
Version | V2.0.0 | | V3.1.0 | |
| Indications for
Use | The Mortara
Surveyor Patient
Monitor is
indicated for use
in adult,
adolescents and
children patient
populations for
the monitoring of
the following
parameters:
• Non-invasive
blood pressure
• Impedance
respiration | The Philips
MX800 is
indicated for
Adult,
Pediatric or
Neonatal) for
the
monitoring of
the following
parameters:
• Non-invasive
blood
pressure
• Impedance
respiration
• Invasive
blood | The Mortara Surveyor
Patient Monitor is
indicated for use in adult,
adolescents and children
patient populations for the
monitoring of the following
parameters:
• Non-invasive blood
pressure
• Impedance
respiration
• Invasive blood
pressure
• Temperature
• Functional arterial
oxygen saturation
(SpO2)
• End-tidal & inspired
CO2
• ECG monitoring with
arrhythmia & ST- | Added |
10
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| • Invasive
blood
pressure | • pressure
• Temperature
• Functional
arterial
oxygen
saturation
(SpO₂)
• End-tidal &
inspired
CO₂ (with
MMS
extension)
• ECG
monitoring with
arrhythmia &
ST-segment
• Cardiac
output | • segment
• 12-Lead resting ECG
• Cardiac output
The Mortara Surveyor
Patient Monitor is
indicated for use in infants
and neonatal patient
populations for the
monitoring of the following
parameters:
• ion-invasive blood
pressure
• Impedance respiration
• Invasive blood pressure
• Temperature
• Functional arterial
oxygen saturation
(SpO₂) End-tidal &
inspired CO₂
• ECG monitoring with
arrhythmia
The 'Bed 2 Bed
communication' feature
allows remote viewing of
monitors when connected
to a Surveyor Central
Station.
The Mortara Surveyor
Patient Monitor is a
prescription device
intended to be used by
healthcare professionals
in all areas of a healthcare
facility. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| neonatal patient
populations for
the monitoring of
the following
parameters:
Non-
invasive
blood
pressure Impedance
respiration Invasive
blood
pressure Temperature Functional
arterial
oxygen
saturation
(SpO₂)
End-tidal &
inspired CO₂ ECG
monitoring
with
arrhythmia 12-
Lead
resting | | |
11
Image /page/11/Picture/0 description: The image shows a logo with the text "K173765" above it. The logo is a blue square with a white heart shape cut out of the center. The heart shape is formed by two curved lines that meet at a point at the bottom and two curved lines that meet at a point at the top.
12
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| g
ECG
The
Mortar
a
Surve
yor
Patien
t
Monit
or is a
prescr
iption
device
intend
ed to
be
used
by
health
care
profes
sional
s in all
areas
of a
health
care
facility
| . | ||
|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -- |
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| Bedside
to
Bedside
(B2B)
Feature | None | Bed-to-bed
overview
provides
clinicians
with an
overview of
all the patient
beds in their
care
(Reference:
Philips_Intelli
Vue_MX800
Technical_
Datasheet). | The 'Bed to Bed
communication' feature
allows remote viewing of
monitors when connected
to a Surveyor Central
Station. The Remote
View and Notification
features are enabled on a
Unit by Unit basis. | Added |
|----------------------------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Viewing
the Other
Bed
Window | NA | The other
Bed Window
lets you view
a subset of
the
waveform
and numeric
information
from another
bed on the
same
network –
Reference
Page 125
Instructions
for USE
4535644175
61(Eng) | The 'Bed to Bed
communication' feature if
enabled, allows remote
viewing of other patient
monitor limited information
when connected to a
Surveyor Central Station. | Added |
| Alarm
occurrence at
another
Bed | NA | The other Bed
window can be
configured to pop-up
automatically when
an alarm occurs at
another Bed. This automatic
pop-up can be
temporarily disabled. | When the 'Bed to Bed
communication' feature is
enabled and the Alarm
Notification is set to ON, it
allows the notification of
alarm at another bed in
B2B window. | Added |
| Accessing remote
patient limited
information | NA | Overview BAR next
to the Monitor's
own Bed Label To Open the Other
Bed Window,
select the required
bed label or patient
name in the Alarm
Status Overview
Bar If you are in a Unit
Group with many
beds, the 'MY
Patients window
may open for you to
select the bed | Touching the Remote
View button displays the
Setup Remote View
menu and the Bed list.
The user can select any
bed on the list to open
the Remote view for the
Bed. | Added |
14
Image /page/14/Picture/0 description: The image shows a blue logo with the text "K173765" above it. The logo is a stylized heart shape, with the top of the heart formed by a curved line and the bottom of the heart formed by two angled lines. The heart is white, and the background is blue. The text is black and is located in the top left corner of the image.
15
Image /page/15/Picture/0 description: The image shows the text 'K173765' above a blue logo. The logo is a square with a heart-shaped cutout in the center. The heart is white, and the square is blue.
| Connect
s
Hospital
Intranet
to
retrieve
other
Patient
informati
| on/data | NA | Yes | Yes | Equivalent |
|---|---|---|---|---|
| Processo | ||||
| r Board | Z1 | Z2 | Equivalent | |
| Network | ||||
| interface, | ||||
| wired | IEEE 802.3 | |||
| Ethernet, | ||||
| 10/100 Mbps | IEEE 802.3 | |||
| Ethernet, | ||||
| 100 Mbps | IEEE 802.3 Ethernet, | |||
| 10/100 Mbps | Identical | |||
| Network | ||||
| interface, | ||||
| wireless | None | IEEE | ||
| 802.11a/b/g | ||||
| 2.4 GHz and | ||||
| 5 GHz Band | Wireless LAN | Added | ||
| Network | ||||
| system | ||||
| compatib | ||||
| ility | Mortara Surveyor | |||
| Network | The | |||
| integrated | ||||
| PC | ||||
| (iPC) allows | ||||
| access to | ||||
| relevant | ||||
| patient | ||||
| information | ||||
| residing on | ||||
| the hospital's | ||||
| intranet. | ||||
| (Reference: | ||||
| Datasheet) | Mortara Surveyor Network | Identical | ||
| Serial | ||||
| interface | RS-232 | IEEE 1073- | ||
| 3.2-2000 | ||||
| Connectors | ||||
| RJ45 (8 pin) | RS-232 | Identical | ||
| Target | ||||
| Populatio | ||||
| n | Adult, | |||
| adolescents, | ||||
| children, infants | ||||
| and neonatal | ||||
| patient | ||||
| populations | Adult, | |||
| pediatric, | ||||
| neonatal | Adult, adolescents, | |||
| children, infants and | ||||
| neonatal patient | ||||
| populations | Identical | |||
| Operatin | ||||
| g Modes | Continuous | |||
| Monitoring | Continuous | |||
| Monitoring | Continuous monitoring | Identical |
16
Image /page/16/Picture/0 description: The image shows a blue logo with the text "K173765" above it. The logo is a stylized heart shape formed by two angled lines meeting at the bottom and curving inward to create the top of the heart. The heart shape is cut out of a blue square, creating a negative space effect.
| 12 Lead
ECG | ECG acquisition
module
model AM12M
with snap end
lead set | X1 multi
measuremen
t module for
12-lead ECG | ECG acquisition module
model AM12M with snap
end lead set | Identical |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------|
| ECG
cable set
for
3/5-wire
applicati
ons | Integrated cables
and trunk cable
with detachable
lead sets
(including for
Neonatal
applications). | X1 multi
measuremen
t module for
3/5 wire ECG | Integrated cables and
trunk cable with
detachable lead sets
(including for Neonatal
applications). | ldentical |
| ECG
input
impedan
се | >2.5 MOhm at 10
Hz | >2 MOhm
RA-LL leads
(Resp)
5 MOhm at
all other
leads (at 10
Hz including
patient
cable) | >2.5 MOhm at 10 Hz | Equivalent |
| 3/5 wire
ECG
lead fail
detection | Active electrode: