Datascope Passport 2, 2LT Monitor - User Manual PDF
Datascope Passport 2, 2LT Monitor - User Manual PDF
Datascope Passport 2, 2LT Monitor - User Manual PDF
Datascope
Passport®
Datascope
Passport®
Datascope
Passport®
Datascope
Passport®
CapnoLine™ and NIV Line™ are trademarks of Oridion Medical Ltd.
Masimo SET®, LNCS® and LNOP® are U.S. registered trademarks of Masimo Corporation.
Microstream® and FilterLine® are U.S. registered trademarks of Oridion Medical Ltd.
Navigator™, Auto-Set™, and View 12™ are U.S. trademarks of Mindray DS USA. Inc.,
Nellcor®, Oxismart®, Oxiband®, and Durasensor® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.
OxiMax® and Max-Fast® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.
Copyright© Mindray DS USA. Inc.,, 2005. All rights reserved. Contents of this publication may not be reproduced in any
form without permission of Mindray DS USA. Inc.,
NIBP Accessories..................................................................................................................................... 5 - 1
Oximetry Sensors and Accessories............................................................................................................. 5 - 2
Pulse Oximetry-Masimo SET® LNOP® SpO2 ....................................................................................... 5 - 2
Pulse Oximetry-Masimo Set® LNCS® SpO2 ......................................................................................... 5 - 3
Pulse Oximetry-Nellcor® OxiMax® SpO2* ......................................................................................... 5 - 4
Oridion CO2 Accessories ......................................................................................................................... 5 - 4
Gas Module Accessories .......................................................................................................................... 5 - 5
Gas Module II and Gas Module SE ................................................................................................... 5 - 5
Gas Module 3 ................................................................................................................................ 5 - 5
Reusable Temperature Probes.................................................................................................................... 5 - 6
Disposable Temperature Probes................................................................................................................. 5 - 6
ECG Accessories ..................................................................................................................................... 5 - 7
ECG Cables ................................................................................................................................... 5 - 7
ECG Leadwires ............................................................................................................................... 5 - 7
12 Lead ECG Accessories ................................................................................................................ 5 - 8
Electrodes ...................................................................................................................................... 5 - 8
IBP Accessories ....................................................................................................................................... 5 - 8
Comm-Port Accessories ............................................................................................................................ 5 - 9
Base Station Accessories .......................................................................................................................... 5 - 10
Miscellaneous Accessories........................................................................................................................ 5 - 10
Mounting Kits and Accessories .................................................................................................................. 5 - 10
Upgrade Kits........................................................................................................................................... 5 - 11
Central Station Accessories....................................................................................................................... 5 - 11
Appendix ......................................................................................................................... 6 - 1
Safety Designations......................................................................................................................................... 6 - 1
Safety designations per IEC 60601-1 Standard........................................................................................... 6 - 1
Performance Specifications .............................................................................................................................. 6 - 3
ECG ...................................................................................................................................................... 6 - 3
ECG Performance Requirements ........................................................................................................ 6 - 3
Analog Output Specifications.................................................................................................................... 6 - 6
3 Lead and 5 Lead ECG .................................................................................................................. 6 - 6
Arterial Blood Pressure ..................................................................................................................... 6 - 7
Sync Pulse for Cardioversion ............................................................................................................ 6 - 7
Systole Detector and Heart Rate Meter ....................................................................................................... 6 - 7
ECG Derived Heart Rate Meter Performance Requirements ................................................................... 6 - 7
IBP Derived Heart Rate Meter Performance ......................................................................................... 6 - 9
SpO2 Derived Heart Rate Meter Performance ..................................................................................... 6 - 9
NIBP Derived Heart Rate Meter ......................................................................................................... 6 - 9
S-T Segment Analysis ............................................................................................................................... 6 - 9
S-T Segment Analysis Performance Requirements ................................................................................. 6 - 9
Arrhythmia Analysis ................................................................................................................................. 6 - 10
12-Lead ECG Interpretation .............................................................................................................. 6 - 11
NIBP Sub-System Performance Characteristics ............................................................................................. 6 - 11
Pressure Measurement System ........................................................................................................... 6 - 12
Pulse Rate ....................................................................................................................................... 6 - 12
Maximum Cuff Pressure .................................................................................................................... 6 - 12
Cuff Inflation ................................................................................................................................... 6 - 12
Maximum Leakage .......................................................................................................................... 6 - 13
Vent Rate ....................................................................................................................................... 6 - 13
NIBP Sub-System Functional Requirements .................................................................................................. 6 - 13
Initial Conditions ............................................................................................................................. 6 - 13
NIBP Starting Pressure Settings and Ranges ........................................................................................ 6 - 13
Foreword
The Passport 2/Passport 2 LT Operating Instructions are intended to provide
information for proper operation.
General knowledge of monitoring and an understanding of the features and functions of the
Mindray DS Passport 2/Passport 2 LT Monitor are prerequisites for its proper use.
Patents: This device is covered under one or more of the following U.S. Patents 4,621,643,
4,653,498, 4,700,708, 4,770,179, 4,869,254, 4,911,167, 4,928,692, 4,934,372,
5,078,136, 5,351,685, 5,368,026, 5,368,224, 5,482,036, 5,490,505, 5,533,507,
5,632,272, 5,685,299, 5,758,644, 5,769,785, 5,823,950, 6,002,952, 6,036,642,
6,067,462, 6,157,850, 6,206,830, 6,247,674, 6,377,845, 4,802,486, 4,960,126,
5,485,847, 5,743,263, 5,865,736, 6,011,986, 6,035,223, 6,263,222, 6,298,252,
6,463,310, 6,501,975, 6,591,123, 6,675,031, 6,708,049, 6,801,797, 6,589,028,
6,896,713, Re.35,122 and foreign equivalents. Possession or purchase of this device does
not convey any express or implied license to use the device with replacement parts which
would, alone, or in combination with this device, fall within the scope of one or more of the
patents relating to this device.
A WARNING is provided to alert the user to potential serious outcomes (death, injury, or
serious adverse events) to the patient or the user.
A CAUTION is provided to alert the user to use special care necessary for the safe and
effective use of the device. They may include actions to be taken to avoid effects on patients
or users that may not be potentially life threatening or result in serious injury, but about which
the user should be aware. Cautions are also provided to alert the user to adverse effects on
this device of use or misuse and the care necessary to avoid such effects.
Warnings
WARNING: Internal Electrical Shock Hazard - This unit does not contain
any user-serviceable parts. Do not remove instrument
covers. Refer Servicing to qualified personnel.
WARNING: Trace Gas Hazard - When using the optional Gas Module, a
health hazard exists when trace amounts of vaporized
anesthetic agents are chronically inspired by operating
room personnel. See Appendix A in NFPA 56A on Inhalation
Anesthetics. During any procedure where such agents are
employed, the Gas Module exhaust output should be
connected to a medical gas-scavenging system.
WARNING: This unit uses a common isolation path for the ECG leads
and the Invasive Pressure Channels. Ensure that conductive
parts of the ECG electrodes do not contact other conductive
parts including earth ground. Do not connect any non-
isolated accessories to the Passport 2 or to the ECG or
invasive pressure channel inputs when connected to a
patient. Insure that the total chassis leakage currents of all
connected units does not exceed 300µA. Use an IEC 601-1
approved isolation / separation transformer if required. Do
not simultaneously touch the patient and any piece of
electrical equipment if any cover has been removed from
the equipment.
WARNING: The AC line cord and interface cables (ie non-patient cables)
may utilize the same ground. Therefore, removal of the AC
line cord does not necessarily isolate the Passport 2, if non-
patient interface cables are attached.
WARNING: The View 12™ ECG Analysis Module is not intended for use
during electrosurgery. If the electrosurgical ground
connection is not satisfactory, there exists a possibility of
patient burns at the ECG electrode sites.
WARNING: Route cables neatly. Ensure cables, hoses and wires are
away from a patient’s neck to avoid strangulation. Keep
floors and walkways free of cables to reduce risk to
hospital personnel, patients and visitors.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min (120 ml/min for Gas
Module 3 with a neonatal water trap). This device should
not be used on patients whose breathing could be impaired
by this vacuum flow rate.
WARNING: The Gas Module water trap, sampling line and airway
adapter should be disposed of in accordance with local
regulations for contaminated and biologically hazardous
items.
WARNING: Do not use other cleaning methods for the DRYLINE™ water
traps. Do not clean or wash the filter housing of the water
trap. Never allow alcohol to enter the filter housing. Never
force air through the water trap.
Precautions
CAUTION: Only use the Abbreviated Operating Check List (0070-00-
0493) if you are already familiar with this product. If not,
please use the Detailed Operating Instructions.
CAUTION: NIBP cuffs must be used with the correct Mindray DS hoses.
See chapter 5.0 for part numbers.
CAUTION: Prior to use, be sure the rail supporting the bed rail
mounting hook can support the weight of the monitor.
Consult the bed manufacturer’s specifications if necessary.
Mindray DS cannot be responsible for injury or damage
resulting from improper or inadequate support of the
monitor.
CAUTION: Removal of the View 12™ ECG Analysis Module without first
disabling the 12-Lead ECG card may cause a temporary
disruption in patient monitoring.
CAUTION: The 2.4 GHz radio optionally used in this device must be at
least 20 cm away from the user and/or patient during
normal operating conditions.
CAUTION: The internal sampling system of the Gas Module does not
need to be cleaned or sterilized. There is no reverse flow
back to the patient. If the internal sampling system is
suspected to be clogged or dirty, the module should be
serviced by an authorized service person only.
CAUTION: The site should be checked at least every eight (8) hours
(every four (4) hours with the Adult re-usable SpO2 finger
sensor). Ensure proper adhesion, skin integrity, and proper
alignment. Nail polish and fungus may affect readings.
Exercise extreme caution with poorly perfused patients.
Skin erosion and pressure necrosis can be caused when
sensors are not frequently monitored. Assess the site every
two (2) hours with poorly perfused patients.
Notes
NOTE: This unit is not designed to be used with a peripheral pulse
sensor. SpO2 is a standard function in this monitor, and may
be used to obtain a plethysmograph waveform and heart
rate.
Intended Use
The intended use for the Passport 2® includes the monitoring of the following human
physiological parameters:
• Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations
are adult and pediatric only, and
• Interpretation of Resting 12 Lead ECG, for which the target population is adult only.
The monitor is intended for use in the health care facility setting.
The device has the capacity of interfacing with Mindray DS’s Gas Modules, displaying the
measurements of Anesthetic Gases, O2, N2O, and CO2.
Unpacking
Remove the instrument from the shipping carton and examine it for signs of shipping
damage. Save all packing materials, invoice, and bill of lading. These may be required to
process a claim with the carrier. Check all materials against the packing list. Contact the
Mindray DS Service Department (800) 288-2121, ext. 8116 for prompt assistance in
resolving shipping problems.
Passport 2
Passport 2
The Passport 2/Passport 2 LT Monitor can be mounted on a rolling stand, a wall mount
bracket, gas machine arm, Bedrail or operated as a tabletop instrument. The Passport 2
monitor can be mounted to a Gas Module. The keypad contains dedicated primary
functions. The menu buttons provide access to setting up patient information, waveforms, and
parameters.
The Passport 2 comes with a color TFT LCD or a monochrome display. The Passport 2 LT
comes with a passive color or monochrome display. Digital displays are provided for Heart
Rate, Non-invasive Blood Pressure (NIBP), Pulse Oximetry (SpO2), Respiration Rate and
Temperature (T1). Additional digital areas present for the Passport 2 are Invasive Blood
Pressure (IBP1 and IBP2) (optional), Anesthetic Agents (optional), O2 and NO2 (optional), ST
(optional), and CO2 (optional). The optional built-in recorder provides hard copies of all
digital data and waveforms as well as Tabular Trend information.
The View 12™ ECG Analysis Module for the Passport 2 enables 12-Lead Acquisition,
Continuous 12-Lead ST Analysis and Arrhythmia Analysis with print capability. The View
12™ ECG Analysis Module consists of a PCMCIA card for insertion into the Passport 2
with 12 Lead software, an M-12 cable and a detachable leadwire set.
The Passport 2 has the capability of interfacing with IABP Systems and Mindray DS’s
Central Stations, Gas Module, Remote Displays and Nurse Call Systems.
The Passport 2 LT has the capability of interfacing with IABP Systems and Mindray
DS's Remote Displays, and Nurse Call Systems.
The optional Gas Module can be used on an anesthesia cart or mounted on a rolling stand
or wall mounted.
The Passport 2/Passport 2 LT monitor can operate with either battery removed so that
fresh batteries can be installed during monitor operation.
• Communication with hospital CIS (Clinical Information Systems) through DIAP (Mindray
DS Improved ASCII Protocol, manual P/N 0070-00-0307) (Passport 2)
• Inter-Monitor Patient Data Transfer (with optional accessories)
• Inter-Monitor System Set-up Transfer (with optional accessories)
• Mounting Kits (optional accessory)
• Soft-Grip Handle
• Comm-Port (optional Passport 2)
• Dual PCMCIA Interface
This section of the Operating Instructions identifies and describes each control and display of
the Mindray DS Passport 2/Passport 2 LT Monitor.
Step-by-step instructions for operation of the monitor are provided in Section 3.0
“Operation”.
1 2 5 8 9
7 13 15 16 18 20
4 12 19
10 14 17 21 22 23
3 6
11
1. (ECG) LEAD
Press this key to select the next ECG lead to display in waveform 1. Each time you press this
key, the next available ECG lead displays.
2. (ECG) SIZE
Press this key to select the next available Size of ECG for Waveform 1. Each time you press
this key, the next available ECG Size displays. When the largest ECG size is displayed, the
next key press displays the smallest size.
3. (ECG) VIEW
Press the VIEW key to see 6 leads of ECG at once when using the View 12™ ECG Analysis
Module or the 5 Lead ECG cable. With a View 12™ ECG Analysis Module installed, press
the VIEW key once to see the first 6 leads of ECG, press again to view another 6 ECG
leads. Pressing a third time will return to normal display view. With a 5 lead ECG cable,
press the VIEW key once to see 6 leads of ECG, press again to return to normal display
view.
NOTE: Pressing the VIEW key does not affect the waveforms being
transmitted to the Central Station.
4. (NIBP) START
Press this key to begin an NIBP measurement or to begin or re-start automatic interval
measurements.
5. (NIBP) INTERVAL
Press this key to modify the NIBP interval measurement time. The choices are: Off, Cont, 1
min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hr, 2 hrs or 4 hrs. The
“Off” selection means that NIBP measurements can only be initiated manually. The “Cont”
selection means that measurements will be continuous (one right after the other). The
continuous measurement interval will only last for 5 minutes and then automatically change
to a 5 minute interval. The 1 minute interval will last for 10 minutes and then automatically
change to a 5 minute
6. (NIBP) STOP
Press this key to stop any NIBP measurement. If the interval mode is activated, pressing this
key disables the interval mode measurements. An NIBP Idle message displays until the
interval mode is restarted. If a Press STOP to clear. message is displayed, pressing this
key will clear a Cuff Overpressure condition.
8. (ALARMS) LIMITS
Press this key to display the Alarm menu. The Alarm menu provides you access to view or
change alarm values.
15. STANDBY
Press this key to place the Passport 2/Passport 2 LT into a STANDBY mode. While in
STANDBY mode, monitoring is discontinued and the alarms are in permanent suspension,
interval NIBP measurements are placed in idle mode, CO2 pump is shut off, and the display
shuts down. When in the STANDBY mode, the message STANDBY. TO BEGIN
MONITORING, PRESS STANDBY is displayed. Press the STANDBY key again to exit
the STANDBY mode and return to the normal screen.
NOTE: Trend data is not cleared in the STANDBY mode. When the
STANDBY mode is released, NIBP INTERVAL is in IDLE MODE
and requires re-activation via the START key. The CO2 pump
automatically reactivates if the Microstream® sensor is in
place.
16. DISCHARGE
Press this key to initiate the process of discharging the patient from the monitor. A menu titled
Patient Discharge will be displayed. Depending on the monitor’s configuration, the
Normal Screen menu choice will be provided along with one or more of the following
selections: Discharge From Monitor, Discharge From Central and Discharge
From Both. If any discharge option is selected, a confirmation box will be displayed.
(Discharging a patient from the monitor deletes all patient trend and demographic data and
places the monitor in STANDBY mode.) An onscreen message will display as follows:
• For Main Module Software Versions Y.xx and earlier, the message STANDBY. TO
BEGIN MONITORING, PRESS STANDBY is displayed.
• For Main Module Software Versions AA.xx and later, the message PATIENT
DISCHARGED. MONITOR IN STANDBY MODE - TO BEGIN MONITORING,
PRESS STANDBY is displayed.
Upon exiting STANDBY mode, the monitor configuration reverts to currently saved settings.
Selecting Normal Screen from the menu aborts the discharge.
2.2 Display
The display of the Passport 2/Passport 2 LT provides menus, waveforms, parameter
information, and messages. Figure 2-2 below shows the layout of the screen. The display can
be a color LCD or monochrome flat panel for the Passport 2 monitor. The display for the
Passport 2 LT is a monochrome panel. The number of waves displayed can vary from 3 to
6 (Passport 2 LT is limited to 3). The default operation follows these basic rules:
a. If a wave and related parameter tile are displayed, they are horizontally linked and
have the same color for easy and clear reading. The ECG parameter may violate
this rule since multiple vectors can be viewed at one time.
b. NIBP and Temperature data is displayed only in the lower row of boxes. With the
Passport 2 monitor, as the fourth, fifth and sixth waves are sensed they will
automatically insert and fill the bottom waveform areas.
c. Font size for parameter data vary with the amount of data on the screen to maximize
the size of the numbers.
The monitor also includes a display set-up function that allows the user to customize the
display. User preferred set-ups can be programmed and saved.
Menu Headings
27
Pat ient Monit or Setup Print Set up Parameters Functions 07/27/04 6:55 PM
LASTNAME, FIRST Adult
HR bpm
P 170
A
S 55
PVC/min: 45
Source: A ut o
Lead mm
II + 2.2
I -2.1
V -3.0
PR bpm
OFF
% 94
Insp
rpm
mmHg
Exp 14
Source: CO2
24
mmHg
T1 Des% O2% N2O%
120 (100)
mmHg
Waveform
Area
Insp
4.0 48 60
NIBP: Idle
F
Exp
1.1 46 58 80 Int erval: ON
ET: 13 min
29
Radio
Icon
25
26 28 30
Parameter Menu Parameter Battery Panorama
Headings Areas Indicator Icon
If the monitor is configured for lithium-ion batteries, when there are no batteries installed, the
battery indicator will be displayed with an “X” through it as shown in the example.
When the battery charge is low, but not below the cutoff voltage, the battery indicator will
begin to flash and a low pitched double beep will be generated every minute.
• If the Passport 2 608 radio is sending data but it is not being displayed at a
Panorama Central Station, then this icon will display the number “1”.
• If the Passport 2 data is being displayed at a Panorama Central Station, then this
icon will display the capital letter “V”.
2.3 Menus
The Main Menu system of the Passport 2/Passport 2 LT is available through the Menu
headings, which are always displayed on the screen. The headings are accessed using the
Navigator™ Control Knob. Turning the Control Knob highlights the Menu headings one at a
time. When the Menu heading that you would like to access is highlighted, press the center
of the Control Knob to display the menu. Turn the Control knob again to highlight items
within the Menus headings and press the Control Knob to select the highlighted item. If
selecting the highlighted item displays more selections, continue using the Control Knob in
the same manner (turn to highlight, press to select) to set the options as desired. The Menu
headings are:
2.3.1 Patient
NOTE: Changes that are made in the Patient Menu do not become
effective until the menu is closed.
Patient
MENU ITEM SELECTIONS DEFAULT/COMMENTS
Patient Size Adult, Pediatric, Adult
Neonate
Gender Unspecified, Male, Default is Unspecified. Use Navigator Control Knob to
Female select patient’s gender.
Date of Birth Default is Unspecified. Use Navigator Control Knob to
select patient’s date of birth.
Last Name A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s LAST name.
First Name A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s FIRST name.
ID #1 A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s ID #.
Bed #2 A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s Bed #.
Height 8" to 120" Adult - 70"
(20 cm to 305 cm) Pediatric - 30"
Neonate - 20"
Weight 0.1 lbs to 1100 lbs Adult - 150 lbs
(0.1 kg to 500 kg) Pediatric - 15 lbs
Neonate - 6 lbs
Admit Patient3 Yes, No Default is No. Select Yes to admit patient to the central
station.(This selection appears only when connected to
a VISA or PatientNet® Central Station.)
1 The “ID #” field can accept a maximum of 15 characters. If a Passport 2 608 radio is communicating
with a Panorama Central Station, only the first 10 characters will be displayed in the “ID” field at the
Central Station.
2 The “Bed #” field can accept a maximum of 15 characters. However, since only the first 5 characters will
be displayed in the “Bed” field at a Panorama Central Station if a Passport 2 608 radio is communicating
with the Central Station, the following standard format for this demographic is recommended:
• Start the string with a room # that has a fixed number of digits. For example, if
the maximum number of digits that is used in numbering the rooms is 4, then for
room 102, a leading zero would be added to get the 4th digit - 0102.
• Follow the room # with a letter to identify the particular bed within the room. For
example, a room with 2 beds would have bed A and bed B.
• An example of a complete “Bed #”: Bed B in room 513 (in a facility where the
maximum number of digits that is used in numbering the rooms is 4) would be
identified as 0513B.
NOTE: If the monitor is communicating with the EMR (Electronic Medical Records) system through a Pan-
orama Gateway, any changes to patient demographics made at the monitor will not be sent to the
EMR system. For further explanation, refer to section 3.26, “Connection to Panorama• Gateway”.
3 Passport 2 only.
2.3.4 Parameters
Parameters Menu
MENU ITEM DEFAULT/COMMENTS
ECG Select to open the respective menu. These can also be selected
ST* through the individual parameter menus.
NIBP
IBP1*
IBP2*
SpO2
CO2*
Resp
Gases*
Temperature
* Passport 2 only.
Functions Menu
MENU ITEM SELECTIONS DEFAULT/COMMENTS
Normal Screen Select to return to normal screen
Copy patient data to Select to copy the patient data to a data
card transfer card.
Copy patient data from Select to copy the patient data from a data
card transfer card.
12-Lead ECG* Disable / Enable Use Navigator Control knob to disable or
enable 12-Lead ECG.
* Passport 2 only with View 12™ ECG Analysis Module. NOTE: If “Enable Network” is set to “Wireless” in the
“System Information” menu, 12-Lead ECG will not be listed as a choice in the Functions Menu.
31
39
T1 IBP 1 IBP 2
32
ECG
33 SpO2
38
34
35
36
37
32. T1 Connector
A standard three wire phone jack used to mate with either the YSI series 400 or 700
temperature probes. The monitor automatically detects which probe is connected.
44
40
41
42
43
49
Passport2
Passpo
™
45 4,928,692
4,934,372
5,758,644
5,769,785
S/N
8888 - 00 - 1234 - 12345
Mindray DS USA Inc.. Paramus, NJ 07652 USA
¨ IEC 601-1:1988
V 100-120~
100-120 / 220-240
220-240~ CSA - C22.2 No. 601.1 - M90
A .75 / .35 UL 2601-1:1997
Hz 60 / 50
48
45. AC Receptacle
Insert an AC power cord into this connector.
For instructions on mounting the remote display to a wall, see the Passport 2 Service
Manual, Installation Guide.
Passport 2
®
125
Lead mm
G P
II +2.2
mV
- S
aVR -2.1
S D
T PVC/min: 45 V1 -3.0
-1 A Source: Auto ST Pt: 80/60
40 RPM
R
E
S
P
18
10 Source: ECG
40
Insp Exp
C
mmHg
0
2 1 /38 mmHg
0 RR (CO2 ) 14 rpm
8
SpO2 PR
S
0
T1 Insp Exp
P
0
2 98
Sys
% 81
Dia
bpm
T A
N
E
M
P
36.7 C
G
T
O2
Des
41
7.6
36 %
5.2 %
I
B
P
120 / 80
Mean (93)
1
N2O 51 54 % Interval: ON ET: 13min
51
55
53 54
50 52
TM
Passport 2
60
59
57
58
62
64
61 63
TM
Passport 2
68
65 67 66
70 71 73
73 74 72
TX LINK
70 71 72
72 74 72
Certain operating characteristics are based on the selected patient size (e.g., NIBP start
pressure). The patient size selection should be matched to the actual patient before
monitoring begins.
a. Using the Navigator™ Knob, highlight Monitor Setup. Press the Navigator Knob
to open the menu.
b. Use the Navigator Knob to select Advanced Setup, then select either Date or
Time.
c. Turn the Navigator Knob to select a new setting. Once the desired choice is
highlighted, press the Navigator Knob.
d. This setting is saved when Yes is selected via the confirmation prompt.
NOTE: Patient trend data is cleared if the Time and/or Date are
changed on the monitor.
If the Passport 2 is connected to a Panorama Central Station, the Time and Date settings of
the Central Station will be acquired by the Passport 2 in one of three ways as follows:
The “Extended Trend” feature is automatically enabled when the unit is powered-up
following card insertion.
5. Patient Set-Up
a. Power ON the monitor. Clear the previous patient’s data by pressing the
“DISCHARGE” key and then selecting “Discharge From Monitor” or
“Discharge From Both” from the Patient Discharge menu.
b. Connect the patient to the monitor, apply appropriate accessories such as ECG
electrodes, NIBP cuff, SpO2 probe, CO2 Filterline®, etc.
c. Open the Patient Menu and enter the patient demographic data. Ensure that the
correct patient size is chosen.
d. If an NIBP cuff has been applied, press the START key to initiate a non-invasive
blood pressure measurement.
The Installation Mode is accessed by pressing and holding the DISCHARGE key during
power on. See the table that follows for descriptions of the Installation Menu choices.
1. Power up the Passport 2/Passport 2 LT while holding down the DISCHARGE key.
2. Set each item as necessary. To save all of the chosen settings, choose “Save current”
before leaving this menu. To return to normal operating mode, power the unit Off and
On again.
The System Information menu is accessed by rotating the cursor to the System Information
selection on the Installation Menu and pressing the Navigator™ Control Knob. Each item on
this screen is accessed in the same manner as the other menus on the monitor. Some items
provide menu choices while others require information to be entered via a keypad-like entry
screen. To enter information, rotate to the desired letter or number and then press the
Navigator™ Control Knob to select. When finished, rotate to the Previous Menu tag and
press the Navigator™ Control Knob. See the table that follows for descriptions of the System
Information menu choices.
NOTE: A cuff that is too narrow for the limb will result in
erroneously high readings. The correct size of the pressure
cuff for a given patient has, among other considerations, a
direct bearing on the accuracy of the obtained NIBP
measurements. Base your selection of the cuff size on the
limb circumference of the patient. The design dimensions of
the cuffs and their intended uses are based on of the
American Heart Association.
NOTE: The pressure on the limb may not fall to zero between
measurements if the cuff is wrapped too tightly. Therefore,
insure that the cuff is properly applied.
NOTE: The NIBP cuff should not be placed on a limb that is being
utilized for any other medical procedure. For example, an IV
catheter or an SpO2 sensor.
4. If not already selected, select the Patient Size through the Patient Menu as described in
Section 2.3. Choices are Adult, Pediatric or Neonate.
5. If necessary, change the initial cuff inflation pressure through the NIBP Menu.
Initial cuff inflation pressures depend on the patient size setting. The choices of cuff inflation
are:
NOTE: Inflate the cuff only after proper application to the patient’s
limb. Cuff damage can result if the cuff is left unwrapped
and then inflated.
The cuff begins to inflate to the selected cuff pressure. After reaching the selected value the
cuff begins to slowly deflate and the Mindray DS Passport 2/Passport 2 LT Monitor
collects oscillometric pulsations.
If the initial cuff inflation is found to be inadequate, the unit retries with a higher inflation
pressure (+50 mmHg in the adult mode; +40 mmHg in the pediatric and neonate modes).
Have the patient remain still to avoid the introduction of unnecessary motion artifact. After
the cuff pressure drops below the diastolic pressure, the results of the measurement are
displayed.
If NIBP is the only parameter being measured with the Passport 2/Passport 2 LT, a heart
rate can be derived from NIBP. The HR source menu selection must be in the Auto mode (i.e.,
not selected for ECG, IBP or SpO2) with no heart rate alarm limits set. (See Alarms
Section 3.19 for details). If another heart rate source is available, the NIBP heart rate will be
replaced by the heart rate from the selected source.
If NIBP is a selected trend source, then NIBP data will be recorded in the trend with the time
stamp of the reading. If NIBP is not a selected trend source, then NIBP data will be recorded
in the trend with the next entry into the trend caused by another trigger (i.e. Alarm, Interval
Entry, or Mark Event key press). The time stamp will be that of the trigger causing the trend
entry. (See Section 3.12 for details on trend triggers).The NIBP measurement and NIBP heart
rate will be automatically removed from the display after a predetermined time interval. The
NIBP timeout interval is 15 minutes by default and can be set to a different value through the
Installation Menu.
7. Select the Interval Mode or the Timer Mode in the Monitor Setup menu.
8. Press INTERVAL until the desired time displays. The choices are: Off, Cont, 1 min, 2
min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hr, 2 hrs or 4 hrs.
9. Press START to begin taking interval measurements.
• When the elapsed time exceeds the pre-set time out in the installation mode (See
Section 3.2)
• If a measurement is unsuccessful, the display values are replaced with “XXX” and a
tone sounds.
The quality of an ECG signal is directly affected by electrode site skin preparation, electrode
patch quality and ECG lead placement. If artifact is present on the ECG waveform, then the
arrhythmia processing, alarm processing, and quality of the monitoring function may be
affected. The presence of artifact can prevent the monitor from establishing an accurate ECG
reference waveform, increasing the difficulty experienced in assessing the ECG rhythm.
Optimizing the ECG signal is imperative for accurate monitoring. Use high quality
electrodes, designed to acquire the ECG with excellent base line stability, recovery from
defibrillation and minimum artifact from patient movement.
With the Passport 2, ECG can be obtained by using a 3 Lead, 5 Lead or 12 Lead ECG
cable in conjunction with a lead set and skin electrodes. With the Passport 2 LT, ECG can
be obtained by using a 3 Lead or 5 Lead ECG cable in conjunction with a lead set and skin
electrodes. For best performance and safety, inspect the ECG cables and electrodes daily.
1. Shave the chest hair from the electrode sites in a circular area with a diameter of
2 – 4 inches.
2. Use a dry gauze pad to remove excess skin oils, skin cells and residue from the
electrode sites. Never rub the skin until it is raw or bleeding.
NOTE: Prepare the electrode site with alcohol only if the skin is
extremely greasy. If alcohol is used as a drying agent,
always allow the skin to dry before placing the electrode
patch on the skin.
1. To prevent evaporation of the contact gel medium, peel the backing off of the electrode
patch only when it is ready for use. Visually inspect the contact gel medium for
moistness. If the gel medium is not moist, do not use the electrode patch. Dry electrode
patches are not conductive.
NOTE: If using the snap type electrode wires, attach the electrode
patch to the leadwire before placing patch on the patient.
2. Attach the electrode patch to the skin at the prepared site. Smooth the electrode patch
down in a circular motion to ensure proper skin contact. If using soft gel electrodes,
never push down directly over the contact gel medium as this may displace the gel and
cause monitoring artifact. If using hard gel electrodes, it is recommended that during
application, the center of the electrode should be slightly pressed onto the skin to ensure
direct contact. Consult the electrode patch manufacturer’s instructions for specific use.
3. Secure the leadwires to the patient according to hospital practice. For additional
information see section 3.4.1.3, “Lead Placement”.
This section outlines lead placement according to the guidelines of the American Heart
Association (AHA).
White Black
RA LA
Red
LL
White Black
RA LA Brown
V Lead
(any position)
V
Green
Red
RL LL
RA LA
V1
V6
V5
V4
RL
V2
V3 LL
Lead II Monitoring
The recommended lead placement for Lead II monitoring is as follows.
White
Black
RA LA
Red
LL
White
Black RA
Red
LA
LL
Select ECG Lead II for MCL6 monitoring. Lead II is the direct electrical line between the RA
(white) electrode and the LL (red) electrode.
Black
White
RA LA
Red
LL
Black V
Brown Black
Red
Green Red
FIGURE 3-10 3-wire Lead Placement for a FIGURE 3-11 5-wire Lead Placement for a
Pacemaker Patient (AHA) Pacemaker Patient (AHA)
Do not place an ECG electrode directly over the pacemaker generator. Place the electrode
patches 3 – 5 inches away from the pacemaker generator area. For example, if the
pacemaker generator is located in the right subclavian area, relocate the Right Arm (white)
electrode closer in towards the center of the chest.
The ECG Menu provides the following choices: Normal Screen, ECG 1 — ECG 6,
Arrhythmia Menu, Relearn, ST Menu, ECG Sizes Menu, ECG Setup and Resp
Menu.
• The Normal Screen selection returns the view to the normal screen.
• The ECG 1 — ECG 6 selections define the ECG labels for printing and trends.
• The Arrhythmia Menu selection opens the Arrhythmia Menu.
• The Relearn selection is only available if the ST or Arrhythmia options are installed and
is used to manually initiate the learning process for ST measurements or Arrhythmia
analysis.
• The ST Menu selection opens the ST Menu.
• The ECG Sizes Menu selection opens the ECG Sizes Menu.
• The ECG Setup selection opens the ECG Setup Menu that is detailed in the following
table.
• The Resp Menu selection opens the Resp Menu.
Monitor = 0.5 - 40 Hz
Extended, 3 or 5-lead = 0.05 - 100 Hz
Extended, 12-lead = 0.05 - 150 Hz
ST = 0.05 - 40 Hz
1. Plug patient cable into the ECG connector. An ECG waveform will be present on the
screen. The heart rate appears to the right of the waveform.
2. Select desired lead setting by pressing the front panel ECG LEAD key. Lead II is
automatically selected at power-up.
3. Select desired ECG size by pressing the front panel ECG SIZE key. An ECG of 1 cm/
mV is automatically selected at power-up.
4. If cascaded ECG is desired in waveform 2, use the Monitor Setup menu (see section
2.3.2), to choose this option.
5. If desired, choose an alternative source for heart rate. Choices are: ECG, IBP1, IBP2,
SpO2, or AUTO. AUTO selects the source from a hierarchy (ECG, IBP1, IBP2, SpO2,
NIBP) of what is currently monitored.
A “CHECK LEAD CONNECTION” message will be displayed if 3 lead or 5 lead ECG has
an intermittent or poor connection. See section 3.4.1.1 for proper skin preparation for
electrode placement.
NOTE: If a 3 or 5 Lead ECG cable and the View 12™ ECG Analysis
Module are both in use, and 12 Lead ECG is enabled, then
“Lead Fault” messages refer to the 12 Lead cable only.
All Passport 2 monitors used with a View 12™ ECG Analysis Module on a hardwired
Panorama Central Station must comply with the following software requirements. Failure to
do so may cause inaccurate information to be printed at the Panorama Central Station laser
printer.
WARNING: The View 12™ ECG Analysis Module is not intended for use
during electrosurgery. If the electrosurgical ground
connection is not satisfactory, there exists a possibility of
patient burns at the ECG electrode sites.
1. Prep patient’s skin as indicated in Section 3.4.1.1 prior to placement of electrodes. See
View 12™ Card (Optional Passport 2) on page 3-17. for proper electrode placement.
2. Insert View 12™ ECG Analysis Module with cable attached into PCM slot 1 on right side
of Passport 2, turn monitor on.
3. To enable 12-Lead (if function is disabled), with the 12-Lead card inserted into PCM slot
1, go to the Functions menu and select “Enable 12-Lead ECG” using the Navigator
Control Knob.
4. To view multiple leads of ECG, press the VIEW key. Press the VIEW key once to view
the first 6 ECG leads, press again to view another 6 leads. Pressing a third time will
return to normal viewing.
5. Select desired leads to view in the View ECG Setup menu within the Monitor Setup
menu.
6. To change sizes of displayed waveforms, go to the ECG Sizes Menu within the ECG
menu.
7. To remove the View 12™ ECG Analysis Module, turn monitor off or go to the Functions
menu and select “Disable 12 Lead ECG”, then use the Navigator Control knob to select
“Yes”.
CAUTION: Removal of the View 12™ ECG Analysis Module without first
disabling the 12-Lead ECG card may cause a temporary
disruption in patient monitoring.
NOTE: If the transducer offset should exceed 120 mmHg, it will not
be possible to automatically zero the transducer. Pressure
values will be xxx and an “UNABLE TO ZERO” message will
be displayed.
CAUTION: The site should be checked at least every eight (8) hours
(every four (4) hours with the Adult re-usable SpO2 finger
sensor). Ensure proper adhesion, skin integrity, and proper
alignment. Nail polish and fungus may affect readings.
Exercise extreme caution with poorly perfused patients.
Skin erosion and pressure necrosis can be caused when
sensors are not frequently monitored. Assess the site every
two (2) hours with poorly perfused patients.
3. The Pleth waveform and digital SpO2 value will be displayed by default in the second
waveform and parameter area.
4. Enter the display set-up menu as described previously in this manual, to display Pleth
waveform and data in an alternative location.
5. Set the “Sensor -Off Audio”, in the SpO2 menu to the desired setting. Set to OFF, the
Passport 2/Passport 2 LT will not give an audio beep when the SpO2 sensor is off
the patient. Set to “ON”, the Passport 2/Passport 2 LT will sound a series of 5
triple beeps.
6. Color - menu selectable, multi-color.
7. Grid - menu selectable On or Off.
8. Masimo® Sensitivity Mode and Post Average Time
Passport 2/Passport 2 LT monitors equipped with Masimo SpO2 allow the user to
adjust Sensitivity and Post Averaging Time. The user should choose the sensitivity mode
depending upon signal quality and patient motion. In most cases, the normal setting will be
appropriate. If the patient motion is limited, high sensitivity can be used.
It is also possible to change the averaging time of the Saturation and Pulse Rate
measurements. The post average time can be changed to 6, 8, 10, 12, 14 or 16 seconds.
If excessive ambient light is present, cover the sensor site with opaque material. Failure to do
so may result in inaccurate measurements. Light sources that can affect performance include
surgical lights, especially those with a xenon light source, bilirubin lamps, fluorescent lights,
infrared heating lamps, and direct sunlight.
In the event that you are unable to get any reading, or the reading you get is inaccurate,
consider the following:
• If your patient is poorly perfused, try applying the sensor to another site - such as a
different finger or toe.
• Check that the sensor is properly aligned.
• In electrosurgery, make sure sensor is not too close to ESU devices or cables.
• Check to make sure the site area is clean/non-greasy. Clean site and sensor if needed.
Nail polish and fungus should be removed.
3.6.3.1 Calibration
The oximetry sub-system incorporates automatic calibration mechanisms. No other
calibration is required.
1. indicated for continuous non invasive monitoring of arterial oxygen saturation (SpO2)
and pulse rate
2. non-sterile
3. usable during patient movement
The LNOP®• DCSC Adult Reusable Spot Check Sensor is used for “spot check” applications.
The LNOP®•DCI Adult Re-usable Finger Sensor can also be used for “spot check”
applications if needed. All sensors are intended for “single-patient use only” unless indicated
as “reusable”.
All Nellcor accessories and sensors must be purchased from Nellcor Puritan Bennett Inc. To
contact Nellcor Puritan Bennett Inc., call 1-800-635-5267.
Only Nellcor® oxygen transducers should be used with the Passport 2 or Passport 2 LT
monitors with Nellcor® Oxismart® or OxiMax® pulse oximetry.
ST deviation
(Depression or Elevation)
ISO Point
ST Point
J Point
P T
Q
40 to 80 msec
S
The depression or elevation of the ST segment is measured as the vertical distance between
the isoelectric (ISO) point which provides the baseline, and the ST point (see Figure 3-11). ST
measurements are available on a maximum of three user selected ECG leads at a point
situated 80 msec (heart rate 120 bpm or less) or 60 msec (heart rate more than 120 bpm)
from the algorithmically determined end point of the QRS (J Point). In addition, the user can
also select from three (3) different settings for the ST measurement point (80, 60, or 40 ms)
from the J-point and independent of heart rate. These measurements are valid only on normal
beats. Abnormal beats, like ventricular beats, are excluded from the analysis of ST segment.
Ventricular paced beats are also rejected from the analysis of the ST segment, because pacer
tails distort the shape of the ST segment.
ST segment changes are continuously measured by the monitor, but update of the displayed
ST data is different depending on the ECG cable in use. When using a 3 or 5 lead ECG
cable, the displayed ST data is updated approximately every 10 seconds.
The Passport 2 initiates the Learning process for ST measurements after one of the
following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling ST analysis
• The lead has been changed in ECG 1 waveform (3 lead only)
• Patient Size is Changed
• Whenever the “Relearn” function is selected from the ST, ECG or Arrhythmia Menus.
It is recommended that a Relearn be initiated after one or more of the following:
3.7.1 ST Setup
Select the waves to be used for ECG. ST analysis is performed on the leads chosen as ECG
1, ECG 2 and ECG 3 on the ECG Menu. ST analysis begins when the feature is turned on
from the ST Menu. By default, ST data will appear in the Heart Rate Tile.
To display the ST data in the second tile, set waveform 2 to display any ECG wave (i.e.
ECG2, ECG3, or ECG1 Cascade), then set “Combine ST/HR” to OFF.
Once waveform 2 has been set to display an ECG wave, the learned ST patterns or ST trend
data may be displayed in place of the ECG wave.
Set “View ST” to “Minitrends” to view the trended data for each analyzed lead. Set “View
ST” to “Averaged ST” view the learned and current ST complex for each analyzed lead.
When View 12™ ECG Analysis Module is installed, continuous 12-lead ST monitoring will be
enabled when “ST analysis” is set to “On”. 12-lead ST analysis may be viewed in 2 modes:
Delta and Absolute. Delta ST is the ST segment change between the learned ST segment and
the present ST segment. Absolute ST is the ST segment change between the “O” baseline
point of the ST and the present ST segment.
To display 12-lead ST data in a tile, set Waveform 2 to display any ECG wave, ST minitrends
or Averaged ST.
A normal ECG waveform typically includes consistent spacing between R waves, a sharp
and well defined QRS complex, and an ECG baseline that is free of noise and artifact.
R
ST deviation
(Depression or Elevation)
ISO Point
ST Point
J Point T
P
Q
40 to 80 msec
S
ST Segment
Some of the causes of ECG noise include poor skin preparation, improperly attached
electrodes, dried electrode gel, defective leadwires, and patient movement. The algorithm
uses several techniques to differentiate a patient’s QRS complexes from noise sources.
If noise levels are too high, the following will occur until the signal quality is re-established:
ECG Amplitude
The QRS detection threshold algorithm setting is fixed between 0.15 and 0.45 mV to avoid
detecting noise spikes or P-waves as valid beats. Changing the display gain on the monitor
does not affect the signal that is used by the algorithm for beat detection. For optimal
performance, the leads selected for monitoring should have an amplitude of 0.5 to 1 mV or
more.
Learning
The process of learning is used to establish a normal beat template for a patient. The learn
period is dependent on the heart rate and the dominant pattern. Learning should not be
initiated during a primarily ventricular rhythm because an ectopic beat may be established
as normal.
A learn should be initiated when beats are not being properly detected, or when they are
being erroneously classified. However, if a signal is not strong enough, or lead data is
extremely noisy, better signal quality must be established before a learn can be effective.
DESCRIPTION 3-WIRE LEAD SET 5-WIRE LEAD SET VIEW 12™ CARD
Leads used for Beat Determined by II and V V1 and V5
Detection viewed lead
Leads used for Beat Determined by II, V, and I V1, V5, and II
Typing viewed lead
Leads used for Determined by II and V V1 and V5
V-Fib Detection viewed lead
The search for the next beat begins after a refractory period to avoid detecting T- waves as
valid QRS complexes. For all patient sizes, the minimum QRS amplitude that can be detected
is between 0.15 and 0.45 mV depending on the width of the QRS complexes.
Beat typing aligns and compares each new heart beat to reference templates that were
previously stored in the system. A beat typing algorithm classifies the beats.
• If an incoming beat matches a template that has already been classified, it is given the
same label as the template. The template parameters are updated with the features from
this new beat.
The real time ECG analysis library incorporates ventricular ectopic beat detection as a part
of arrhythmia analysis.
• Beats are measured for compensatory pause, QRS width, QRS positive and negative
areas, and R wave positive and negative amplitudes. This process uses multiple leads
when available.
• A scoring algorithm is then applied to those measurements to determine whether or not a
beat is ectopic.
ST deviation is the vertical distance between the isoelectric (ISO) point level and signal level
at ST point. The ST point is located 40 to 80 milliseconds beyond the J-point.
The ISO point is located between the end of the P-wave and the onset of the QRS complex.
The ISO point provides the baseline for this measurement.
The ST point is a fixed distance from the J point at the end of the QRS complex. The ST point
can be configured to 40, 60, or 80 milliseconds past the J-point, independent of the heart
rate. By default, the ST point is positioned as follows:
• at 80 milliseconds for heart rates less than or equal to 120 beats per minute
• at 60 milliseconds for higher heart rates
ST data is calculated on the averaged beat, and not on individual beats. The reliability of ST
measurements is lowered with the presence of atrial fibrillation, flutter, and erratic baseline
changes.
All available ECG leads are analyzed to measure deviations in the ST segment.
Learning
The process of learning is used to establish normal beat templates or a stable baseline for
accurate ST analysis. To establish this baseline, the system evaluates the first sixteen normal
beats based on readings from leads I, II and V.
To establish an accurate baseline, it is recommended that learning be done when the patient
is in stable condition, not moving, and has an ECG rhythm that is free of artifact. Learning
should not be initiated during a primarily ventricular rhythm or other ECG rhythm irregularity
because an ectopic beat may be established as normal.
ECG Filters
The ST segment of an ECG waveform often contains low amplitude signals with low
frequency content. To preserve low frequency signal content, the high pass filter is set to 0.05
Hz when ST analysis is turned on.
The following lethal and non-lethal arrhythmia alarms may be detected by the arrhythmia
algorithm.
NOTE: Lethal arrhythmia alarms are latched alarms. Even after the
alarming condition is resolved, a latched alarm will continue
until it is acknowledged by pressing the MUTE or MUTE ALL
key on the front panel keypad. If the alarm is
acknowledged while the lethal condition still exists, the
audio portion of the alarm will be muted for the duration
that is selected from the “Mute For” list in the “Alarm
Setup” menu, but the alarm message will remain in
message area A. If a new lethal condition occurs while the
initial lethal alarm is muted, the new lethal alarm will not
break through and will be muted for the remainder of the
mute duration. If the lethal condition is resolved while the
alarm is muted, the alarm will be terminated.
Asystole Alarm
An Asystole alarm is activated when no QRS complexes are detected for the configured
time period in the absence of Ventricular Fibrillation.
For 3-Lead and 5-Lead ECG – The time period range for an Asystole alarm is user
selectable from 3 to 10 seconds.
For 12-Lead ECG – The time period range for an Asystole alarm is user selectable from 3 to
8 seconds.
• The V-TACH rate may be set between 100 and 180 beats per minute.
• The number of consecutive PVCs may be set between 3 and 15 beats.
A V-TACH alarm is a Priority 1 alarm event that produces:
Bigeminy Alarm
The Bigeminy alarm is activated when three or more cycles of one PVC coupled to one
normal beat are detected.
Couplet Alarm
The Couplet alarm is activated when two consecutive PVCs are detected between normal
beats.
NOTE: The Irregular Heart Rate alarm is not available when using
a View 12™ card.
The Irregular Heart Rate alarm is a Priority 2 alarm event that produces:
Pause Alarm
The Pause alarm is activated when no beat is detected during an interval that is greater
than 1.8 R-R and the next beat is not a PVC.
NOTE: The Pause alarm is only available when using a View 12™
card.
PVC/minute Alarm
The PVC alarm is activated when the number of PVCs detected per minute exceeds the
configured threshold. The PVC limit can be set to Off, or 1 to 30 PVCs per minute.
• If the High PVC alarm priority is set to 1, Alarm Priority 1 visual and audio alarm
indicators are produced.
• If the High PVC alarm priority is set to 2, Alarm Priority 2 visual and audio alarm
indicators are produced.
Run Alarm
The Run alarm is activated when the number of consecutive PVCs occur at a rate that equals
or exceeds the user defined V-Tach Rate. The number of consecutive PVCs that constitute a
Run is one beat less than the minimum used to identify V-Tach.
Trigeminy Alarm
The Trigeminy alarm is activated when three or more cycles of one PVC coupled to two
normal beats are detected. This rhythm could also cause an Irregular HR alarm.
The other arrhythmia alarms are classified as Priority 2 by factory default. The
characteristics and priority level of the “PVC/min” alarm can be changed at the user’s
discretion via the Alarm Limits Setup menu.
The following alarm calls can be made when Arrhythmia Analysis is set to “All On” (default
setting):
• Pause
The following alarm calls will be made when Arrhythmia analysis is set to “Non-lethals Off”:
The Passport 2 initiates the Learning process for Arrhythmia measurements after one of the
following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling Arrhythmia analysis
• The lead has been changed in ECG 1 waveform (3 lead only)
• Patient Size is Changed
• Whenever the “Relearn” function is selected from the ST, ECG or Arrhythmia Menus.
It is recommended that a Relearn be initiated after one or more of the following:
The List Trend display allows the user to view a tabular list of stored patient vital signs and
anesthetic gas data. Press the TRENDS key to access this display. A maximum of 120 time-
stamped entries may be stored. If the “Extended Trend” option is installed, a maximum of
500 time-stamped entries may be stored. When the maximum number of entries has been
reached, the oldest entry will be deleted from the trend record in order to allow storage of a
new entry.
The left side of the List Trend display contains menu items for scrolling, setup, and access to
other displays. Trend data is listed from newest to oldest. Use the Vertical Scroll feature to
view older data. Use the Horizontal Scroll feature to view all the columns of data.
Scroll bars along the right and bottom sides of the trend display indicate the position of
viewed data in relation to the rest of the database. Upon reopening of the trend screen, the
last viewed data position will be displayed at the top of the trend screen.
The leftmost column of the List Trend display contains markers which indicate if the entry was
triggered by an alarm violation or MARK EVENT keypress. On color displays these markers
are red for priority 1 alarms, yellow for priority 2 alarms, and green for MARK EVENT
keypresses. On monochrome displays these markers are bold for priority 1 alarms, half-
brightness for priority 2 alarms, and normal brightness for MARK EVENT keypresses.
Trend data in violation of an alarm is also highlighted according to the priority of the alarm.
On color displays this data is red for priority 1 alarms and yellow for priority 2 alarms. On
monochrome displays this data is bold for priority 1 alarms and half-brightness for priority2
alarms.
If data for a parameter was not available at the time of the trend entry, the data field will be
dashed. If an NIBP reading could not be obtained or an invasive pressure channel was not
zeroed at the time of the trend entry, the data field will contain “xxx”.
Pressing the MARK EVENT key will always cause a Trend entry.
Trend entries triggered by the Interval setting above may be filtered out from the displayed
List trend data. To change the amount of interval entries displayed, select “Setup” from the
List trend menu. Once in the Setup Menu, select “Display Interval” and set as desired. The
choices available for the “Display Interval” depend on the setting of the “Trend Entry
Interval” setting above. (If the “Trend Entry Interval” is set to “Off”, there will be no choices
available for “Display Interval”.)
1. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
2. Access the Functions Menu of the source monitor, and select “Copy patient data to card”
from the menu. A status message will report completion of the transfer. (This section is
grayed-out if a transfer card is not plugged into the PCMCIA slot A.)
3. Remove the card and insert it into the PCM2 slot of the receiving monitor.
4. Access the Functions menu of the receiving monitor, and select “Copy patient data from
card”. A status message will report completion of the transfer.
All trend data is automatically cleared when the patient is “discharged” from the monitor.
All trend data is also cleared if the monitor’s displayed time or date is changed.
The Graph Trend display allows the user to view a graphic summary of stored patient vital
signs and anesthetic gas data. To access this display from the normal monitoring screen,
press the TRENDS key twice. To access this display from the List Trends display, press the
TRENDS once. This display may also be accessed from the other trend displays via menu
selection.
The left side of the Graph Trend display contains menu items for scrolling, setup, and access
to other displays. The Graph Trend data window contains up to 4 parameter displays. Use
the Vertical Scroll feature to view other parameters.
Time stamps are included at the top of the window, with the most recent data appearing at
the right end. Use the Horizontal Scroll feature to move the cursor though time. Scroll bars
along the right and bottom sides of the trend display indicate the position of viewed data in
relation to the rest of the database. The Event Scroll feature may be used to scroll quickly
between events (caused by Alarm entries and MARK EVENT key presses).
The Rescale Waves feature automatically rescales the viewed parameters’ graphs so all data
is displayed. The Zoom feature may be used to adjust the amount of time shown in the trend
window.
The top line of the Graph Trend display contains markers which indicate if the entry was
triggered by an alarm violation or MARK EVENT keypress. On color displays these markers
are red for priority 1 alarms, yellow for priority 2 alarms, and green for MARK EVENT
keypresses. On monochrome displays these markers are bold for priority 1 alarms, half-
brightness for priority 2 alarms, and normal brightness for MARK EVENT keypresses.
As the cursor is scrolled horizontally, the digital data corresponding to the points in the graph
is shown at the right side of the window. Trend data in violation of an alarm is highlighted
according to the priority of the alarm.
On color displays:
• Priority 1 alarm data is shown in inverse video with background at full brightness.
• Priority 2 alarm data is shown in inverse video with background at half brightness.
If data for a parameter was not available at the time of the trend entry, the data field will be
dashed. If an NIBP reading could not be obtained or an invasive pressure channel was not
zeroed at the time of the trend entry, the data field will contain “xxx”.
All trend data is automatically cleared when the patient is “discharged” from the monitor. All
trend data is also cleared if the monitor’s displayed time or date is changed.
Events
Normal Screen
11:40 12:00 Cursor 11:46
300 HR
The OXY CRG (Oxygen Cardiorespirogram) display allows the user to view a continuously
updated graphic summary of 5 specific patient vital signs. This display is available for
Neonate and Pediatric patient sizes only. To access this display from the normal monitoring
screen, press the TRENDS key 3 times. To access this display from the List Trends display,
press the TRENDS key twice. To access this display from the Graph Trends display, press the
TRENDS key once. This display may also be accessed from the other trend displays via
menu selection. A maximum of 6 minutes of data may be stored. If the “Extended Trend”
option is installed, a maximum of 12 hours of data may be stored. When the maximum
storage time has been reached, the oldest data will be deleted from the database in order to
allow storage of new data.
The general operation and format of the OXY CRG menu items and display is the same as for
Graph Trend display described previously.
All trend data is automatically cleared when the patient is “discharged” from the monitor.
All trend data is also cleared if the monitor’s displayed time or date is changed.
Choke blocks are electrical filters that may be used in electro-cautery environments where
ECG interference can be substantial. These filters remove the electro-cautery noise, but also
block the signal used by the Passport 2/Passport 2 LT Monitor to measure respiration.
The filling and emptying of the heart chambers can interfere with the thoracic impedance
signal, so called cardiovascular artifact (CVA), such that the respiratory signal matches the
heart rate. The Passport 2/Passport 2 LT warns the operator when the respiration value
equals the heart rate by displaying the CVA message.
If the patient’s airway is obstructed and the patient attempts to breath, then the chest wall can
move and create a respiratory signal even though no gas flow is occurring in the patient.
This source will switch to CO2 if a Gas Module has been setup in the Installation Mode and
is connected to the Passport 2. If the Gas Module has not been connected, the source will
be ECG.
3. Open spring loaded door and connect the proper filterline to the Monitor. Connect the
opposite end to the patient.
NOTE: Ensure all tubing connections are secure. Ensure that the
nasal cannula is away from all sources of CO2 (including the
patient’s and your own exhaled breath and ventilator
exhaust valves) during the warm up period.
4. When the Passport 2 has detected valid breaths, numbers will display for ETCO2,
Inspired CO2 and Respiratory Rate.
5. The CO2 respiration waveform and data will automatically replace the ECG Respiration
waveform and data on the display. If respiration wave or data is not displayed, use the
DISPLAY Setup Menu, to select RESP or CO2 to be displayed on Waveform 2, 3 or 4.
6. If desired, the CO2 waveform scale can be changed through the CO2 menu.
NOTE: See Installation Mode Section 3.2, for CO2 Units selection.
Use Calibration Gas, P/N 0075-00-0033-01 and a Microstream FilterLine®, P/N 0683-0-
0468-01.
1. Connect the tubing that comes with the Calibration Gas to the gas canister and to the
filterline. Attach the calibration gas / tubing assembly to the Microstream® port on the
Passport 2.
2. Select the CO2 parameter tile by rotating Navigator™ Control Knob clockwise and
pressing the Knob after the CO2 button is highlighted. (The same menu can be accessed
by using the “PARAMETERS” tile and rotating to CO2 and pressing the Knob.)
3. Select the CALIBRATE option and press the button on the gas canister to begin
releasing the gas mixture.
CO2 Menu
Calibration Menu
Previous Menu
Start
3/15/99 at 11:44 AM
4. Select the START option in the Calibration Menu. Once the “START” option has been
selected, no CO2 waveform data will be displayed.
CO2 Menu
Calibration Menu
Previous Menu
Start
3/15/99 at 11:44 AM
6. With the proper gas mixture being applied, the message “Calibrating, continue to apply
5% CO2” will remain in the menu. When the message changes to “Calculating,
calibration gas can be removed”. Release the button and remove the connector from the
canister.
CO2 Menu
Calibration Menu
Previous Menu
Start
3/15/99 at 11:44 AM
CO2 Menu
Calibration Menu
Previous Menu
Start
3/15/99 at 11:44 AM
7. After a moment, the message will change to “Calibration Completed Successfully”. The
date and time of the successful calibration will appear in the body of the Calibration
Menu.
8. Rotate the Navigator™ Control Knob to the selection for “Previous Menu” and press to
select.
CO2 Menu
Calibration Menu
Previous Menu
Start
3/15/99 at 11:44 AM
9. Rotate the Navigator Control Knob to select the “Normal Screen” and press to return to
the monitors normal display screen.
NOTE: The Passport 2 will interface to the Gas Module via the SP1
Connector on the Comm-Port mounted onto the Passport 2.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min (120 ml/min for Gas
Module 3 with a neonatal water trap). This device should
not be used on patients whose breathing could be impaired
by this vacuum flow rate.
3.18.1 Sequence for Monitoring Anesthetic Gases, O2, N2O and/or CO2
NOTE: To prevent moisture from entering the pneumatic system,
ensure that the Gas Module is always installed and
operated in the horizontal orientation shown in all graphical
depictions.
1. Turn on the Gas Module and Passport 2, and configure the Passport 2 Serial Port to
be used with the Gas Module. Set alarms as necessary.
®
Passport 2
P/N 0683-00-0452-10
HR
Lead mm
P II + 2 .2
S aV R -2 .1
D PV C/mi n : 4 5 V 1 -3 .0
A Sou rce: A u to S T P t: 80 / 6 0
RPM
R
E
S
P
18
Sou rc e : E CG
In s p E x p
C
0
2 1/3 8 mmHg
RR (CO2 ) 14 rp m
8
Sp O2 PR
S
P
0
2 % 81 bp m
T1 In sp Exp Sy s Di a
T A
N
E
M
P
36 . 7 C
G
T
O2
De s
41
7 .6
36 %
5.2%
I
B
P
1 20 / 80
M e an (93 )
1 N 2O 51 54 % In terval : ON E T : 13 mi n
or
P/N 0683-00-0452-10
Pat ient/ADT Monitor Set up Alarms Trend Record 11/9/98 10:28 am
Juan Valdez /Room 1420 / BED 2
E HR
C Lead mm
G
-
S
T
125
PVC/min: 45
Source:Auto
II
aVR
V1
STPt: 80/60
+2.2
-2.1
-3.0
RPM
R
E
S
P
18
Sou rce: ECG
Insp Exp
C
0
2 1 /38 mmHg
RR (CO2 ) 14 rpm
SpO2 PR
S
T1 Insp Exp
P
0
2 98
Sys
% 81
Dia
bpm
A
T N
E
M
P
36.7 C
G
T
O2
Des
41
7.6
36 %
5.2 %
I
B
P
120 / 80
M ean (93)
1
N2O 51 54 % Interval: ON ET: 13min
or
VIEW STOP MUTE PRINT MARK
TREND EVENT
2. For non-intubated patients, apply the nasal cannula to the patient. For intubated patients
connect the sample line to the breathing circuit. Refer to instruction provided in the
packets.
3. Connect the other end of the nasal cannula or sample line to the Gas Module at the
Input Port. Do not connect anything to Reference Port on the rear of the Gas Module II or
SE. This port is used to monitor the room air only. Ensure all tubing connections are tight.
4. Check for a clean water trap. If cleaning is necessary, consult Section 4.9 for details.
5. Select Gas Module CO2 or AUTO as the Resp. Source in the Resp Menu.
6. Observe the capnogram on the monitor’s display. On Passport 2/Passport 2 LT
powerup, O2, Agent and N2O numbers will display. CO2 numbers will be displayed
when a valid breath is detected.
7. If not already set, use the Monitor Setup Menu to select the gas waveforms to be
displayed in Waveform area 2, 3 or 4.
8. If desired, the Gas waveform scale and speed can be changed by entering the Gases
menu. See Section 2.3 for Menusdetails.
1. Verify that the appropriate water trap is properly installed and that the appropriate
sampling line is connected.
• DRYLINE™ Adult/Pediatric water trap used with DRYLINE™ Adult/Pediatric sampling
line (colorless Luer lock nut)
• DRYLINE™ Neonatal water trap used with DRYLINE™ Neonatal sampling line (blue
Luer lock nut)
2. Verify that the water trap container is less than half full.
3. Occlude the sampling line and verify that the occlusion alarm functions properly.
4. Breathe into the sampling line and verify that a CO2 waveform is correctly displayed on
the monitor.
5. Sample room air for 30 seconds and verify that the monitor oxygen output is 20.95%
(± sensor inaccuracy).
Always verify accuracy using a full canister of Mindray DS approved precision calibration
gas, after calibration is performed (See Chapter 5.0, Accessories for the Mindray DS Part
Number). Never use calibration gas that has expired, has a different concentration, or a
canister that is indicating low pressure. The pressure indicator on the Mindray DS gas
regulator must operate in the green zone during the entire calibration session.
1. Select Calibrate from the Gas Menu. The menu shown will appear
2. Select the calibration gas type from the choices, and START to begin calibration.
Start
3. At the start of the calibration, the Gas Module will zero the gas channels. After a
successful zeroing, the Gas Module will request the calibration gas.
4. The message “Feed Calibration Gas” will appear. At this point, attach the calibration
gas canister to the regulator and turn it on. Increasing gas values will appear in the
window as the Gas Module samples the calibration gas.
5. When sampling is complete, the “Feed Calibration Gas” message will disappear,
“Adjusting” will appear next to each value and an “Accept” menu item will appear. If
the values are acceptable, select “Accept”. If for any reason, it is desired to cancel
calibration, press Abort to re-install the previous calibration values.
NOTE: For Gas Module 3, if any input data is corrupt or if there are
other errors, a “Calibration Error” message will appear
after the “Accept” button is selected. The Gas Module 3 will
not accept span calibration with errors in any channel.
3.19 Alarms
The Passport 2/Passport 2 LT provide high and low alarm limits for heart rate (HR),
Systolic, Diastolic, and Mean Pressure (NIBP), respiration rate, SpO2 and temperature. The
Passport 2 monitor also provides alarms for ST level, ventricular arrhythmia, low and high
alarm limits for Systolic, Diastolic and Mean Pressure (IBP1 and IBP2), inspired/expired
CO2, O2 and N2O. Alarms for apnea delay time are available within the Passport 2/
Passport 2 LT.
NOTE: Alarms can be set for any active parameter through the
main Alarm limits menu. To set other parameter’s alarms,
enter the Alarms Setup option. Alarm limits can be set
separately for each patient size from the Alarm Limits Menu.
Alarm limits are not saved when the monitor is turned off,
unless you select “Save Current” in the Monitor Setup menu.
NOTE: Alarm limits can be set using the “Auto-Set” function. Alarm
limits can be saved in the Monitor Setup Menu. The “Save
Current” option must be selected in order to save the current
parameters.
Alarm Parameters
HIGH LO
PARA
METERS ADULT PED NEONATE ADULT PED NEONATE
Heart Rate Off, Off, Off, Off, Off, Off,
(bpm) 60-250 100-300 100-350 30-120 30-150 30-200
PVC/ min Off, 1-30
Run** 4 / 4-8
ST Single Off, +0.5 - +10.0 (Elevation) Off, -0.5 - -10.0 (Depression)
Lead (mm)
ST Dual Off, +0.5 - +10.0 (Elevation) Off, -0.5 - -10.0 (Depression)
Lead (mm)
NIBP Sys Off, Off, Off, Off, Off, Off,
(mmHg) 70-240 40-180 40-180 50-150 15-130 15-130
NIBP Mean Off, Off, Off, Off, Off, Off,
(mmHg) 60-200 50-180 40-160 40-140 10-100 10-70
NIBP Dia Off, Off, Off, Off, Off, Off,
(mmHg) 40-130 50-100 50-100 30-120 10-50 10-50
IBP1/IBP2 Off, Off, Off, Off, Off, Off,
Sys (mmHg) 5-300 5-240 5-180 0-150 0-130 0-130
IBP1/IBP2 Off, Off, Off, Off, Off, Off,
Mean 5 - 150 5 -100 5 - 100 2-100 2 - 50 2-50
(mmHg)
IBP1/IBP2 Off, Off, Off, Off, Off, Off,
Dia (mmHg) 0-140 0-100 0-70 0-120 0-100 0-50
SpO2 (%) Off, Off, Off, 50-99 50-99 50-99
80-100 80-100 80-100
T1 (°F) Off, 95-110 Off, 80-100
T1 (°C) Off, 35-43 Off, 26-38
Resp Rate Off, Off, Off, Off, Off, Off,
(rpm) 10-100 15-150 30-200 5-30 5-40 5-50
ET CO2 Off, 20-80 Off, 5-50
(mmHg)
ET CO2 (%) Off, 2.0-10.0 Off, 1.0-6.0
ET CO2 (kPa) Off, 2.0-10.0 Off, 1.0-6.0
Insp CO2 Off, 5-30
(mmHg)
** Passport 2 only with 3-lead or 5-lead.
PARA
METERS ADULT PED NEONATE ADULT PED NEONATE
Insp CO2 (%) Off, 1.0 - 4.0
Insp CO2 Off, 1.0 - 4.0
(kPa)
ET O2 Off, Off, Off, Off, Off, Off,
40-100 40-100 40-100 10-60 10-60 10-60
Insp O2 Off, Off, Off, 18-60 18-60 18-60
40-100 40-100 40-100
ET N2O Off, Off, Off, Off, Off, Off,
10-80 10-80 10-80 5-70 5-70 5-70
Insp N2O 10-80 10-80 10-80 Off, Off, Off,
5-70 5-70 5-70
Apnea Delay 10-60 10-20 10-20
(seconds)
** Passport 2 only with 3-lead or 5-lead.
All Gas Module alarms are in units of % and increment in units of 0.5.
• +/- 20% of absolute value for: CO2, Gases, IBP’s and NIBP
• HR and Resp. Rate: +/- 30%
• Temp: +/- 3.0%.
Press YES to confirm the Auto-Set in the Confirmation window when it appears.
Warnings are HIGH priority and activate a red LED. Cautions are lower priority and activate
a yellow LED on the keypad.
A. Parameter Alarms
An alarm condition exists if the parameter is equal to or is outside the high/low limit range.
When an alarm limit is violated, the following actions occur:
• The red or yellow alarm LED flashes, according to the priority of the alarm.
• An alarm tone is sounded (unless it is muted with the MUTE ALL key), according to
the priority of the alarm.
• The recorder prints the currently selected waveform (if Record On Alarm is selected
from the Recorder menu).
The data for the violated parameter is displayed in reverse graphics in the parameter
window.
On color displays:
On monochrome displays:
• Priority 1 alarm data is shown in inverse video with background at full brightness.
• Priority 2 alarm data is shown in inverse video with background at half brightness.
If a parameter is being monitored but data is not being displayed, an alarm message will be
posted at the top of the display.
NOTE: Only the value displayed in the heart rate window is used
to determine heart rate alarm conditions.
C. Apnea Alarm
The Apnea Alarm is active when respiration is being monitored. The Apnea alarm is violated
when breathing is not detected for a longer period of time than the apnea delay specified in
the Alarms Menu. When the alarm is silenced by pressing MUTE or MUTE ALL, the alarm
tone will cease to be heard. The mute period, as set in the Alarms Menu, will now begin to
count down. If normal breathing occurs during the selected time frame for “MUTE”, the
Alarms Muted for... message will disappear. Apnea is a Priority 1 alarm.
E. General Alarms
ALARMS OFF ICON - If both high and low alarms are not set for a parameter, an
alarm off icon, resembling a crossed bell, will be displayed next to the numerical data for
that parameter.
VOLUME KEY - The loudness of the alarm can be adjusted through the Monitor Setup
Menu.
ALARM MUTES - One or more alarms can be muted for a programmable length of time.
The following is a description of how to enable the different mute modes.
MUTE - This key is a single action button, which when pressed, silences the alarm
whose parameters have been violated for a programmed length of time (Default 2 minutes),
or until the alarm condition is no longer present, which ever is shorter. Any new alarms that
occur during the silenced period will disable the silence and the alarm will sound the tone.
An Alarm Mute icon, resembling a crossed speaker, is displayed next to each muted
parameter. A message and digital timer counts down in the upper message area. Pressing
MUTE again does not re-enable audio alarms
MUTE ALL - This is a single action button, which when pressed, suspends alarms on
all parameters for a programmed period of time. (Default is 2 minutes). An Alarm Mute icon
(resembling a crossed speaker) is displayed next to each parameter. A message and timer
appear in the upper message area showing the time remaining. Pressing MUTE ALL at any
time re-enables audio alarm tones. If MUTE ALL was permanently selected a message is
posted stating All alarms muted permanently.
The time period for MUTE and MUTE ALL is adjustable via the ALARMS SETUP Menu.
POWER ON
Normal Operation 1 beep
Runtime Stack Failure 2 beeps
DRAM Memory Failure 3 beeps
PCMCIA Boot Checksum Failure 4 beeps
PCMCIA Image Checksum Failure 5 beeps
Flash Checksum Failure 6 beeps
Flash Programming Error 7 beeps
DRAM Checksum Error 8 beeps
ALARMS
High Priority 3 beeps followed by 2 beeps,
repeated every 5 seconds
Low Priority 3 beeps, repeated every 30 seconds
NORMAL OPERATION
CO2 Occlusion 2 beeps repeated every 4 seconds
NIBP Unable to Measure 1 beep
Low Battery 2 beeps every minute
NOTE: All grid patterns and data are printed by the recorder.
NOTE: When the waveforms are frozen and STRIP is pressed, the
recorder prints 8 seconds of the frozen displayed
waveforms.
Press the PRINT TREND key while the List Trend is displayed,
to print a list trend report. See Section 4.7 for Recorder
Paper Replacement.
The waveform for rule-scaled waveforms (i.e. ECG) will be an exact rendering. However,
non-rule scaled waveforms will be transformed to fit the full excursion of the 40mm waveform
window at the selected scale. The baseline of printed waveforms will follow that of the
displayed waveform
The two waveforms are printed in a separate field format with two centimeters assigned to
each waveform. The waveforms do not overlap. Grids are printed as for one waveform.
The upper and lower borders are printed as for the single waveform.
The list trend data is printed with text running along the length of the strip. If more than one
page of data is available then all additional pages are printed along the length of the strip.
NOTE: IBP1, IBP2, CO2, and Gas Module data is printed only when
models are equipped with these options.
NOTE: The print format can be changed via the PRINT SET UP Menu.
Digital parameter data can be placed either in the leader or
the top and bottom of the waveform.
To print 12 Lead ECG data and analysis on the internal thermal recorder, press the VIEW
key, then press STRIP. The recorder will print the patient’s demographic data vital sign data
(as for a normal waveform printout) followed by a 2 ½ second sample of each of the 12
ECG vector waveforms. The waveform samples represent the 2 ½ seconds prior to pressing
STRIP. These waveforms will be followed by ECG measurement data (Ventricular rate, PR
interval, QRS duration, QT/QTc and P-QRS-T axes). If all conditions have been met for ECG
analysis, the recorder will add this following the ECG measurement data. The analysis will
consist of an interpretive statement, a condition statement, and a rhythm statement as
specified in the Physician’s Guide to Computerized ECG Analysis (Mindray DS P/N’s 0070-
00-0524-01 English, 0070-00-0524-50 all other languages).
To print the Average ST Complex, use the Navigator Control knob to select the Print Setup
menu, then scroll and select Average ST Complex.
The recorder will print the patient’s demographic data, followed by the average ST complex
for each of the 12 ECG vectors, then followed by the current ST data for each of the 12 ECG
vectors.
Below the digital information and interpretation are 2-½ second samples of each of the 12
ECG vector waveforms displayed in standard 12-Lead format. The waveform samples
represent the 2-½ seconds prior to pressing the STRIP key. Beneath the 12 ECG waveform
samples is a 10-second rhythm strip of ECG Lead II.
The interface allows the Passport 2 waveforms and data to be displayed at the VISA or
PatientNet Central Stations. The interface also enables the Passport 2 to admit to,
discharge from, and print at the VISA or PatientNet Central Stations.
NOTE: See the VISA Operating Instructions for more details on VISA
operation.
Refer to the Panorama Operating Instructions Manual for a list of supported parameters.
When the Panorama Central is selected for operation, the Patient Discharge menu selections
will vary as follows:
• For Main Module Software Versions Y.xx and earlier, “Discharge From Central” and
“Discharge From Both” will be displayed.
• For Main Module Software Versions AA.xx and later, “Discharge From Both” will be
displayed.
When “Discharge From Central” or “Discharge From Both” are selected from the Patient
Discharge menu, the Panorama will discharge the patient.
If Trend is cleared or the patient is discharged at the Passport 2, the Passport time and date
will be synchronized with the Panorama Central Station time and date.
For the Passport 2 to be recognized by the EMR system, certain demographics content,
referred to as the “Patient Key”, must be entered from its Patient Menu. Each facility has its
own unique “Patient Key” that must be entered before making a connection to the EMR. The
“Patient Key” consists of the required ID # and, optionally, one or more of the following
Patient Menu demographics fields:
Once the “Patient Key” has been entered, communication with the EMR system must be
verified. Since the Panorama Gateway can be purchased with ADT messaging only, Results
messaging only or ADT messaging with Results messaging, this verification differs as follows:
ADT messaging
For a Panorama Gateway that has ADT messaging, verify that communication with the EMR
system has been established as follows:
• After entering the “Patient Key” in the Patient Menu, select Normal Screen to close the
menu.
• If demographics information corresponding to the following fields was not part of the
“Patient Key” but is entered into the EMR system, these fields in the Patient Menu should
auto-populate upon re-opening the menu:
• In addition, the First Name and Last Name should populate in the upper right of the
display.
• If the fields do not auto-populate, verify that the “Patient Key” has been correctly entered
and that the patient demographics have been entered in the EMR system. If the fields still
do not auto-populate, contact the EMR administrator.
Results messaging
For facilities with a Panorama Gateway that has Results messaging, verify that
communication with the EMR system has been established by checking the charting system to
ensure that vital signs data has been uploaded. If the charting system is not displaying the
information, contact the EMR administrator.
4.1 Introduction
This section of the manual outlines routine maintenance that should be performed by the user.
The Passport 2/Passport 2 LT Monitor is designed for stable operation over long
periods of time and under normal circumstances should not require technical maintenance
beyond that described in this section. However, it is recommended that routine maintenance
calibration and safety checks be performed at least once a year or more often as required by
local statutory or hospital administration practice.
To prevent scratches on the front panel display screens, blow or carefully brush dust and dirt
particles with a soft sponge moistened with cleaner solution; or a fine, soft-hair brush. DO
NOT use abrasive cleaning materials. Fingerprints and stains may be removed by using a
liquid lens cleaner and a soft cloth. DO NOT wipe a dry screen or use alcohol or chlorinated
hydrocarbon solvents.
Decontamination of a unit that has come in contact with a biological material can be
performed using LpH SE Germicidal detergent. Apply a small amount of detergent to a
disposable wipe (paper based) and wipe down the outside of the unit. Discard the wipe
appropriately. After waiting 10 minutes, use a clean dry wipe to dry the unit.
• Daily, check the sensors and cables for signs of damage. Replace as required.
• The sensors should be cleaned before and after each patient’s use.
• Wipe the patient contact area using a soft cloth with mild soap and water solution or
isopropyl alcohol. Hydrogen peroxide can be used to remove dried blood on all
accessible surfaces.
• Let the sensor completely dry before using.
NIBP cuffs can be sterilized with gamma sterilization without effecting the repeated
performance of the cuff. Steam sterilization is not recommended. Use of a washing liquid
containing bleach is not recommended because chlorine will chemically break down the
urethane on the inside of the cuff.
Antimicrobial Definition
Mindray DS bladderless cuffs are treated with an antimicrobial coating. Antimicrobial
technology effectively controls a broad spectrum of bacteria, fungi, algae and yeasts on a
wide variety of treated substrates.
Lithium-Ion
Storage of the lithium-ion batteries depends on temperature, time period and the degree of
cell charging state. After 6 months of storage at 23oC, fully charged lithium-ion batteries
have a retention capacity of 93%.
NOTE: If the recorder door does not open completely, carefully pull
it until it is completely open.
• Ultraviolet Light
We recommend storing the recordings in a filing cabinet within a few days of printing.
Long term exposure to natural or artificial U.V. sources may be detrimental.
• Solvent Reactions
Do not store the recordings in plastic bags, acetate sheet protectors, and similar items
made from petroleum products. These products emit a small amount of vapor which will,
over a period of time, deteriorate the image on the chart paper.
• Adhesive Tape
Never place adhesive tape over recordings. The reaction between the adhesive
compound and the Chemical/Thermal paper can destroy the image within hours.
• Archives
We recommend that if long term archives are required, make a photocopy of the
recordings as back-up. Under normal office filing conditions the recordings should retain
acceptable image quality for about 5 years.
1. The Gas Module enclosure may be cleaned with a mild soap and water solution or
ammoniated window cleaner. Apply cleaning solution to the cloth, not directly onto the
Gas Module. DO NOT apply large amounts of liquid. DO NOT use abrasive cleaning
agents or organic solvents.
CAUTION: The internal sampling system of the Gas Module does not
need to be cleaned or sterilized. There is no reverse flow
back to the patient. If the internal sampling system is
suspected to be clogged or dirty, the module should be
serviced by an authorized service person only.
2. The fan dust filter should be checked and cleaned on a regular basis, at least once every
two months.
• Locate fan on front panel.
• Remove the filter by pulling the dust filter cover.
• Remove the dust from the filter.
• Let the filter soak in a mild detergent solution.
• Rinse the filter and let dry completely before re-installing.
3. The Water Trap Reservoir must be checked and emptied whenever changing patients or
if it is more than half full.
• To remove the water trap, push the water trap latch to the right. The water trap is
spring loaded and will pop out. An Air Leak message will be displayed. The monitor
will suspend sampling.
• Detach the reservoir from the water trap assembly by pulling it down carefully.
• Empty the reservoir and rinse with water only.
• Re-attach the reservoir to the assembly tightly.
• Re-install the whole unit into the Gas Module making sure the latch is set. Check that
the Air Leak message disappears and monitoring resumes.
1. The Gas Module enclosure may be cleaned with a mild soap and water solution or
ammoniated window cleaner. Apply cleaning solution to the cloth, not directly onto the
Gas Module. DO NOT apply large amounts of liquid. DO NOT use abrasive cleaning
agents or organic solvents.
CAUTION: The internal sampling system of the Gas Module does not
need to be cleaned or sterilized. There is no reverse flow
back to the patient. If the internal sampling system is
suspected to be clogged or dirty, the module should be
serviced by an authorized service person only.
2. The DRYLINE™ Water Trap Assembly consists of a filter housing and reservoir that must
be checked and emptied whenever changing patients or if it is more than half full.
• To remove the DRYLINE™ Water Trap Assembly from its receptacle, press the lugs on
its sides and pull out. An Air Leak message will be displayed. The monitor will
suspend sampling.
• Detach the reservoir from the filter housing by twisting and separating these two parts.
• Empty the reservoir and rinse with water only.
• Tightly re-attach the reservoir to the filter housing.
• Re-install the DRYLINE™ Water Trap Assembly into the Gas Module, ensuring that it
snaps into place. Check that the Air Leak message disappears and monitoring
resumes.
If the M-12 cable or PC card require maintenance or service, please contact the Mindray DS
Service department at 1-800-288-2121.
YSI 700
DESCRIPTION PART NUMBER
Adult Rectal / Esophageal 0206-00-0701
Skin Surface 0206-00-0709
5.1.7.4 Electrodes
Ethernet (CS1)
DESCRIPTION PART NUMBER
CAT 5 Ethernet Cable, Patch, STP, 6’ (1.83 m) 0012-00-1274-01
CAT 5 Ethernet Cable, Patch, STP, 25’ (7.62 m) 0012-00-1274-02
CAT 5 Ethernet Cable, Patch, STP, 50’ (15.24 m) 0012-00-1274-03
CAT 5 Ethernet Cable, Patch, STP, 1’ (0.30 m) 0012-00-1274-04
CAT 5 Ethernet Cable, Patch, STP, 2’ (0.61 m) 0012-00-1274-05
CAT 5 Ethernet Cable, Patch, STP, 3’ (0.91 m) 0012-00-1274-06
CAT 5 Ethernet Cable, Patch, STP, 10’ (3.05 m) 0012-00-1274-07
Laser Printer, Laserjet 4200N 0992-00-0091-04
Paper, Laser Printer, View 12 0683-00-0503
ECS, HUB, 12 Port 0992-00-0085-01
CAT 5 Ethernet Cable, Crossover, STP, 3’ (0.91 m) 0012-00-1392-05
CAT 5 Ethernet Cable, Crossover, STP, 6’ (1.83 m) 0012-00-1392-06
CAT 5 Ethernet Cable, Crossover, STP, 10’ (3.05 m) 0012-00-1392-07
CAT 5 Ethernet Cable, Crossover, STP, 20’ (6.10 m) 0012-00-1392-08
Degree of protection against electric shock: ECG and IBP, Type CF defibrillation protected.
NIBP, Type BF defibrillation protected. SpO2,
CO2, and Temperature, Type BF
Degree of Electrical Connection between Equipment designed for direct electrical and
Equipment and Patient: non-electrical connection to the patient
Five Lead Displayable Leads: I, II, III, aVR, aVL, aVF, V (n)
Twelve Lead Displayable Leads: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,
V6
3 Lead and 5 Lead Connector Types: Standard AAMI six pin or HP cable
compatible.
3 Lead or 5 Lead Cable Detection: Automatic detection of three wire or five wire,
with Mindray DS auto-detecting cables.
Input Bias Current: < 100 nA per lead, excluding driven lead
(ANSI/AAMI EC13-1992, 3.2.5 or ANSI/
AAMI EC 11-1991 3.2.10).
3 Lead and 5 Lead Drift Rate: 10 µV/s maximum, referred to input, with all
leads shorted through 25KΩ resistors. Total
drift shall be less than 500 µV over a 1 hour
period per ANSI/AAMI EC 13-1992,
3.2.9.11.
Frequency & Impulse Response 12 Lead Meets the frequency response and impulse
configuration: response requirements of ANSI/AAMI EC11-
1991, 3.2.7.2, A and D (0.67 to 40 Hz
sinusoidal and -10% for 20 msec triangle).
Amplitude: 2 V min.
Resolution: 1 bpm.
Alarm Response Time: < 10 seconds for 60 bpm low limit alarm to
sound when stepping from heart rate of 80 to
0 bpm and 80 to 40 bpm (ANSI/AAMI
EC13-1992, 3.2.8.4 and 5).
< 10 seconds for 100 bpm high limit alarm to
sound when stepping from a heart rate of 80
to 120 bpm (ANSI/AAMI EC13-1992,
3.2.8.6).
Tall T-Wave Rejection: Rejects T-waves less than 120% of 1mV QRS,
and Q-T interval of 350 ms per AAMI EC13-
1992, 3.1.2.1 (c).
12 Lead ECG:
Does not reject pacer pulses with tails
(overshoot/undershoot).
Heart Rate Averaging: 3/5/12 Lead ECG: The average heart rate is
calculated as follows:
Mean R to R interval in the last 16 R to R
intervals (HR > 48 bpm).
Mean R to R interval in the last 4 R to R
intervals (HR ≤ 48 bpm).
Default ST Measurement Point: 80 ms after J point for heart rates ≤ 120 bpm.
User Selectable ST Measurement Points: 40, 60 and 80 ms after J point (heart rate
independent) or 60/80 Heart Rate
Dependent.
• The following Arrhythmia calls are made during 12 Lead ECG mode:
Asystole, Pause, Couplets, Runs, Bigeminy, Trigeminy, Ventricular Tachycardia,
Ventricular Fibrillation, PVCs per minute, Ventricular Rhythm.
2
Neonate - Blood pressure measurements determined with this device are equivalent to those
obtained by an intraarterial blood pressure measurement device, within the limits prescribed
by the American National Standard, Electronic or automated sphygmomanometers.
If the cuff is not inflated to the desired pressure within 60 seconds then the cuff is vented and
a retry cycle is initiated up to 3 times.
The Maximum Measurement Cycle Duration shall be 180 sec for Adult and Pediatric patients
(reference EN601-2-30, 1995).
The Maximum Measurement Cycle Duration shall be 90 sec for Neonatal patients (reference
EN601-2-30, 1995).
During a measurement, if the initial cuff inflation pressure is found to be inadequate, the unit
shall retry with a higher inflation pressure (+50 ±10 mmHg in Adult and Pediatric modes and
+40 ±10 mmHg in Neonatal mode).
In interval mode only, the unit shall adjust the inflation pressure according to the previous
systolic pressure. After the first successful measurement is made, the subsequent inflation
pressure becomes +50 ±10 mmHg in the Adult and Pediatric modes and +40 ±10 mmHg in
Neonatal mode.
Configurations of the patient monitor which include IBP have two (2) identical IBP connectors.
Either or both may be used at a given time.
Resolution: 1 bpm
Step Change Response Time: less then 10 sec, 80 to 120 bpm Adult/
Pediatric/Neonatal
less then 11 sec, 80 to 40 bpm Adult/
Pediatric/Neonatal
YSI 400:
Tip: Thermistor
Sleeve: Common/Ground
YSI 700:
Tip: Thermistor 1
Ring: Thermistor 2
Sleeve: Common/Ground
Inclusive Accuracy, 400 Series Probes: ± 0.1°C (25°C - 42°C), ± 0.2°C (otherwise)
± 0.2°F (77°F - 108°F), ± 0.4°F (otherwise)
Inclusive Accuracy, 700 Series Probes: ± 0.2°C (25°C - 42°C), ± 0.4°F (77°F -
108°F)
Scale: Selectable °C or °F
Probe Excitation - 700 Series < 200 µA, Tip to Sleeve and < 30 µA
maximum, Ring to Sleeve
6.2.10 Respiration
6.2.10.1 ECG Respiration Performance Requirements
Leads: Primary lead shall be II. User selectable to
lead I.
6.2.11 SpO2
• SpO2 is a non-invasive measurement of the functional oxygen saturation.
• The SPO2 function is in accordance with the requirements of EN 865.
Sensor Compatibility:
Neonates3: 70% to 100% ± 3, 0% to 69% unspecified.
NOTE: This time was measured with post average time set at 8
seconds.
2The
Masimo MS-3 pulse oximeter with LNOP®•Adt sensors has been validated for motion
accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies
while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm
and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced
hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and
ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
3The
Masimo MS-3 pulse oximeter with LNOP®•Neo and LNOP®•NeoPt sensors has been
validated for motion accuracy in human blood studies on neonates while moving the
neonates foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
4The Masimo MS-3 pulse oximeter has been validated for low perfusion accuracy in bench
top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of
greater than 0.02% and a % transmission of greater than 5% for saturation’s ranging from
70% to 100%. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
5
The LNOP•Ear Sensors have an SpO2 accuracy of 70% to 100% ± 3.5 for adults during
no motion conditions, however, since the monitor cannot display 1/2 digits, the accuracy
shall be rounded to ± 4 digits.
6The
SpO2 accuracy during motion conditions is not specified for the LNOP•Ear Sensors.
6.2.12 CO2
The Passport 2 is capable of providing CO2 measurements from either an Oridion
MediCO2 capnography module, or an Oridion MiniMediCO2 capnography module.
The CO2 performance is in accordance with the requirements of EN 864 (MediCO2) or ISO
21647:2004 (MiniMediCO2).
The accuracy specification is maintained to within 4% for the following gas mixtures (all
values are in Vol. %)
ANESTHETIC
CO2 N2 O2 N2O H2 0 AGENTS
0 to 13 0 to 97.5 0 to 100 0 to 80 Dry to According to
Saturated EN864
Above 80% O2, 1mmHg has to be added to the upper tolerance of the accuracy
specifications.
The accuracy specification is maintained to within 4% of the values indicated in the table
above in the presence of interfering gases according to ISO 21647 clauses 51.101.3 and
101.1.
Self-Maintenance (SFM) is performed only during measurement mode. The module performs
one or more of the following:
• During the first hour after entering measurement mode, periodically for durations of
typically 10 seconds at a rate which limits the total time consumed by SFMs to less
than 2% of the time in which active measurements are taken. Following the first hour
after entering measurement mode, periodically for durations of typically 10 seconds at
a rate of at most once per hour.
• If a change of 8 °C from the last AZ is detected.
• If a pressure change of 20 mmHg relative to the last ambient pressure measurement
(less than the purge threshold) for a period of 30 seconds is detected. The module will
be able to detect a real change in the ambient pressure and a pressure change due to
partial blockage of the FilterLine.
System Response Time: The system response time (with a standard-length FilterLine)
which includes the delay time and rise time (10% to 90%) in
response to a step change in the CO2 concentration is 2.9
seconds typical.
Pump Calibration Interval: No routine calibration is required. The module should initially
be calibrated after 1200 operating hours, then once a year
or after 4,000 operating hours, whichever comes first.
6.2.14 Printer
The printer is a two trace maximum thermal strip chart printer with integral paper spool. The
number of traces are user selectable. The printer uses plain white thermal paper 5 cm wide
and supports 5 paper speeds: 3.125, 6.25, 12.5, 25, and 50 mm/sec.
6.2.15 Comm-Port
Communication with external devices (i.e. VISA or Patient Net Central Station, Remote
Display, Gas Module and Nurse Call System) is accomplished via the Comm- Port. The
Comm-Port is permanently mounted in a recess on the under side of the monitor.
• Remote VGA Display - Connection to a medical grade VGA monitor for remote repeater
display P/N 0160-00-0022. The display mimics the main display (15 pin D-subminiature
female connector).
• Nurse Call - The Nurse Call function interfaces to hospital nurse call systems. The
connector is a 3-pin DIN connector. The monitor activates a relay, which resides in an
interface cable P/N 0012-00-1277-02. The cable interfaces with “normal open”
signaling systems with a minimum of 1,500VAC isolation.
• Serial Communication Channel Supports Passport 2 to Visa (with Admit) protocol,
PatientNet protocol, Mindray DS Improved ASCII Protocol (DIAP)1, Accutorr
Communications Protocols2 and Gas Module. The interface is proprietary.
• Ethernet Communications Port - Supports Passport 2 interface to Panorama Central
Station or to laser printer using 100 BASE-TX Ethernet.
1The
Passport 2 supports the DIAP (P/N 0070-00-0307) with the following exceptions:
• The NIBP elapsed time is set to “—-” when the elapsed time is greater than 999
minutes.
• Though not specified in the protocol, the alarm limit values are at the same resolution
as the parameter value. Example, temperature is 10X, therefore, the alarm limit values
are also 10X.
• Baud rate is 9600 or 19200.
2The
Passport 2 supports the Accutorr Communication Protocol (P/N 0070-00-0304) with
the following exceptions:
6.2.17 Battery
The monitor will operate from AC Mains power with or without the internal batteries
installed.
Minimum Battery Run Time: 1 hour and 50 minutes from two fully charged
new batteries at 25°C with 3 Lead or 5 Lead
ECG, SpO2, no CO2, no printing, and the
NIBP running at the 15 minute interval.
Time to Shutdown from Low Battery: >10 minutes but < 20 minutes after indication,
with 2 new, fully charged batteries with no
CO2 and printer.
Minimum Battery Run Time: 5 hours from two fully charged new batteries
at 25°C with 3 Lead or 5 Lead ECG, SpO2,
no CO2, no printing, and the NIBP running at
the 15 minute interval.
Time to Shutdown from Low Battery: >10 minutes but < 20 minutes after indication,
with 2 new, fully charged batteries with no
CO2 and printer.
6.2.18 AC Power
• 100 – 240 VAC (+/-10%), 50 or 60 Hz (± 3 Hz)
• 1.2 – 0.7 Amps
The Real Time Clock keeps time whether the rest of the system has power or not. A dedicated
battery provides standby power for the clock circuit.
1. AC Mains Power
2. External DC from base station
3. Internal battery power
1. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
2. Access the Functions menu, and select “Copy monitor defaults to card” from the menu. A
status message will report completion of the transfer.
3. Remove the card and insert it into the PCM2 slot of the receiving monitor.
4. Enter Installation Mode on the receiving monitor (Press and hold the DISCHARGE key
during power-up.), and select “Copy monitor defaults from card”. A status message will
report completion of the transfer.
5. Select “Save Current” and power-cycle the receiving monitor to enter normal monitoring
mode.
NOTE: The Extended trend card must be removed prior to using the
12-Lead ECG features.
6.2.25 Display
Size: 10.4” (diagonal) active matrix TFT
Operating Temperature: 10 °C to 40 °C
• EN 60601-1
• UL 60601-1
• CSA Standard C22.2 No. 601.1M90
• EN 60601-1-1/IEC 60601-1-1
• EN 60601-1-4/IEC 60601-1-4
• EN 60601-2-27/IEC 60601-2-27
• EN 60601-2-30/IEC 60601-2-30
• EN 60601-0-25/IEC 60601-2-25
• EN 60601-2-49/IEC 60601-2-49
The View 12™ ECG Analysis Module complies with AAMI EC 11 for Diagnostic
Electrocardiographic Devices.
The Passport 2/Passport 2 LT has been tested for functionality following ESU
(Electrosurgery Unit Interference) energy exposure as described in the draft Amendment A1
to IEC 60601-2-25.
• EN 60601-1/IEC 60601-1
• UL 60601-1
• CSA Standard C22.2 No. 601.1M90
The Gas Module II and Gas Module SE have been certified by CSA.
• EN 60601-1/IEC 60601-1
• UL 60601-1
• CSA Standard C22.2 No. 601.1M90
• EN 60601-1-1/IEC 60601-1-1
• EN 60601-1-4/IEC 60601-1-4
• ISO 21647
TABLE 6-1
EMISSIONS
TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions Group 1 The Passport 2/Passport 2 LT uses RF energy only
CISPR 11 for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class A The Passport 2/Passport 2 LT is suitable for use in
CISPR 11 all establishments other than domestic establishments and
those directly connected to the public low-voltage power
Harmonic Class A
supply network that supplies buildings used for domestic
emissions IEC
61000-3-2 purposes
Voltage Complies
fluctuations/
Flicker
emissions IEC
61000-3-3
TABLE 6-2
TABLE 6-3
Recommended separation
distance
Conducted RF 3 Vrms 3 Vrms d = 1.2 x P
IEC 61000-4-6 150 kHz to 80
MHz
TABLE 6-4
TABLE 6-5
EMISSIONS
TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions Group 1 The Gas Module SE and Gas Module 3 use RF
CISPR 11 energy only for their internal function. Therefore, their RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class A The Gas Module SE and Gas Module 3 are suitable
CISPR 11 for use in all establishments other than domestic
Harmonic Class A establishments and those directly connected to the public
low-voltage power supply network that supplies buildings
emissions IEC
used for domestic purposes.
61000-3-2
Voltage Complies
fluctuations/
Flicker
emissions IEC
61000-3-3
TABLE 6-6
TABLE 6-7
Recommended separation
distance
Conducted RF 3 Vrms 3 Vrms d = 1.2 x P
IEC 61000-4-6 150 kHz to 80 MHz
TABLE 6-8
Blood has weight and it is this weight that influences these blood pressure readings. The
value of the weight of blood depends on where the measurement is taken with respect to the
heart. When the patient is supine, on a flat surface, the arm is near enough to the heart level
so no adjustment of the NIBP readings will be necessary.
• Position and support the limb in such a way as to minimize stretching of and weight
exertion on affected nerves.
• Avoid cuff placement that applies pressure on the ulnar nerve. Cuff tubing should not exit
the cuff over the course of the ulnar nerve at the elbow.
• Select a measurement interval that provides adequate venous drainage during cuff
deflation.
• Periodically inspect the limb bearing the cuff in order to detect venostasis.
If you question the accuracy of the Passport 2/Passport 2 LT check it (the Passport 2/
Passport 2 LT) with a manometer. See the Calibration Section of the Passport Service
Manual.
Auscultatory verification can be made at the same time the Passport 2/Passport 2 LT is
taking a measurement. Apply a bell stethoscope over the brachial artery. Do not allow the
stethoscope to touch either the patient’s clothing or the pressure cuff.
• Try to measure infants when they are calm. A kicking/crying baby may disturb or jiggle
the cuff, causing noise within the system and, as a result, yielding unstable blood pressure
readings. If necessary, hold the cuffed limb steady, but do not impede circulation; do not
hold onto the cuff and do not “pat” the cuffed limb to comfort the child.
• Try the calf. Irritable newborns will react to the cuff pressure but may tolerate the calf
better than the arm. Place the cuff just above the ankle.
• Use the correct size cuff. Mindray DS offers Newborn and Infant size cuffs. When
applying, verify the cuff’s “Index” line falls between the “Range” lines.
• Try disposable cuffs. Disposable cuffs are more pliant than the reusable ones. They
generally fit really tiny infants better.
• Place the cuff lightly. If the cuff is too snug, it won’t work properly. On infants, you should
be able to easily move the cuff over the limb.
Remember NIBP cannot be taken under all conditions. Even manual methods, employing a
sphygmomanometer and stethoscope, will not work on unstable or active patients.
Please include the instrument model number, the serial number, and a description of the
problem with all requests for service.
Any questions regarding the warranty should be directed to the nearest Mindray DS location.
A list of international offices, along with their phone numbers, is provided at the end of this
manual.
6.11 Warranty
6.11.1 USA, Canada, Mexico, and Puerto Rico
Mindray DS USA Inc. warrants that its products will be free from defects in workmanship and
materials for a period of one (1) year from the date of purchase except that disposable or
one-time use products are warranted to be free from defects in workmanship and materials
up to a date one year from the date of purchase or the date of first use, whichever is sooner.
This warranty does not cover consumable items such as, but not limited to, batteries, external
cables, sensors, cuffs, hoses, or mounts.
Mindray DS USA Inc. shall not be liable for any incidental, special, or consequential loss,
damage, or expense directly or indirectly arising from the use of its products, liability under
this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or
replacing at Mindray DS Corp’s option at the factory or at an authorized Mindray DS
Distributor, any product which shall under normal use and service appear to the Company to
have been defective in material or workmanship.
No agent, employee, or representative of Mindray DS USA Inc. has any authority to bind
Mindray DS USA Inc. to any affirmation, representation, or warranty concerning its products,
and any affirmation, representation or warranty made by any agent, employee, or
representative shall not be enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty or merchantability or fitness, and of any other obligation on the part of the
seller.
Damage to any product or parts through misuse, neglect, accident, or by affixing any non-
standard accessory attachments or by any customer modification voids this warranty.
Mindray DS USA Inc. makes no warranty whatever in regard to trade accessories, such
being subject to the warranty of their respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Mindray DS, freight prepaid to Mindray DS
USA Inc., Mahwah, New Jersey 07430. Mindray DS USA Inc. shall not have any
responsibility in the event of loss or damage in transit.
Calibration may be performed without the need to disassemble the instrument. It is the
responsibility of the purchaser to perform calibration as necessary, in accordance with the
instructions provided in this manual.
Except as otherwise provided herein, the terms, conditions and limitations of Mindray DS’s
standard warranty shall remain in effect.
Mindray Medical Netherlands B.V.• P.O. Box 26 • 3870 CA Hoevelaken • The Netherlands •
Tel: +31 33 25 44 911 • Fax: +31 33 25 37 621
Mindray (UK) Limited • 3 Percy Road • St. John’s Park • Huntingdon • Cambridgeshire PE29 6SZ •
United Kingdom • Tel: 01480 416840 • Fax: 01480 436588
Mindray Medical France SARL • Europarc Créteil •123, Chemin des Bassins •
94035 Créteil Cedex • France • Tel: (0)1.45.13.91.50 • Fax: (0)1.45.13.91.51
Mindray Medical German GmbH • Zwischen den Bächen 4 • 64625 Bensheim • Germany •
Tel: +49.6251.17524-0 • Fax: +49.6251.17524-20
Mindray Medical International Ltd. • 2813 Office Tower, Convention Plaza • No 1 Harbour Road •
Wanchai • Hong Kong • Tel: +852 2793 5596 • Fax: +852 2344 8824
0002-08-8918