GE Dinamap Pro 100-400 User manual

Page 1
DlNAMAP@
Series 100-400 Monitor
Operation Manual
PRO
Page 2
Df
NAMAP” PRO Monitor
Operation Manual
This manual is for 200, 300, and
l PRO 100: BP and Pulse l PRO 200: BP, Pulse, and Temp l PRO 300: BP, Pulse, and l PRO 400: BP, Pulse, Temp, and
DINAMAP@
400, all with printers.
PRO Monitor Models 100,
SpO,
SpO,
The model of the Monitor determines which menu option
buttons appear on the LCD. Please refer to applicable
sections.
Changes occurring between issues are addressed through Change Information Sheets, Addendums, and replacement
pages. If a Change Information Sheet does not accompany
this manual, it is correct as printed.
Errors and Omissions
If errors or omissions are found in this manual, please notify: Critikon Marketing Services 4502 Woodland Corporate Boulevard
Tampa, FL 33614
1-877-274-8456
Part No. 776995C
The content of this document including all figures and
drawings is proprietary information of Critikon, provided solely for purposes of operation, maintenance or repair, and dissemination for other purposes or copying thereof is
prohibited without prior written consent by Critikon, Tampa,
Florida.
Illustrations may show design models; production units may
incorporate changes.
Page 3

Contents

Introduction
About
Product Compliance Symbols
the
......................
Getting Started
Unpacking Power Powering Rear Panel Connections.
Switching the Monitor On Liquid Crystal Display (LCD) Using the Printer
Sources
t.he
Front Panel Controls and
Installing the Paper Printer Alarms Storage
......................................................................................................................
Using the Monitor
Noninvasive Blood Pressure Determination Procedures Manual Mode Auto
Mode
Stat
Mode Predictive Temperature Procedures spa*
........
Procedures Troubleshooting
Using the Menu System
Introduction Liquid Crystal Display
....
Rotor Menu Tree Main Menu Vitals Button
More Button SetBPButton Alarms Button Trend
Print Button
More
SpO2
Config Button
Pwr
Time
Rotor Display Button Service Button Clinician Menu Error and Warning Messages Alarms
......................................................................................................................
...
Button
Menu
...
Button (Models 300 and 400)
Sav
(Sleep
..........................................................................................................................
..........................................................................................................................
Button
Appendix A
Technical Specifications
..........................................................................
DINAMAP@
........
..............................................................................................
.
PRO
Monitor..
......................................................................................
.................................................................
....................................................................
.
Monitor
the
..........
Monitor
........................................................................................................
and
Accessories
.............................................................................................
.
........................................................................
.......................................................................................
Indicators
and
...............................................................................
....................................................................................................
.................................................................................................
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....................................................................
Off
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.
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.
.
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...
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.
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Determination
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.,..,...,................,.............................................,........................,
........
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All
(UK:
.........................................................................................................
BP
(UK:
.........................................................................................................
............................................................................................................
..............................................................................................................
...........................................................................................................
.........................................................................................................
Mode)
........................................................................................................
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.......................................................................................................
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.
..................................................................................
Obs)
.
Mode)
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.
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.....
7
7
70
11
13
13 13 13 16 17 19 19 20 20 21 21
23
23 27 29
29 30
3 1
32 34
..........
36 39
43
43 43 46 46
.__
46
47 48 48 49
51 53
53 54 54 54 55
56 56 57 58
.62
62
63
63
Page 4
BP. . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IVAC
Temperature
.,.........,.....
SpOz Mechanical
Power Requirements Environmental
Appendix B
Patient Alarms System Alarms . .
Failsafe Alarm Hierarchy
of
Appendix C
Principles
of
Appendix D
Compatibility Table and Reorder Codes
Appendix E
Warranty, Repairs Packing Service Manuals .
Service,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instructions
Appendix F
Maintenance Cleaning the
Cuff Cleaning and Disinfection Temperature
SpOz
Sensors
Storage and Battery Care
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fuses
Calibration . .
Leak Testing . . Disposal of Product Waste . . .
Appendix
Connection Host
Port Connector
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
..,......._,._,....,..,.,......,,.........
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
_...........
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.............
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
_..__...._....,............................................................................................
Alarms
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pressure
Noninvasive
Blood
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.*......
Parts
Spare
and
. . . . . . . . . . . . . . .
.._............................,....,.....................
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*...........................
. . . . . . . . . .
Monitor . . . . . . . . . . . . .
Devices
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.._...._.....
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
G
Details
.._.....................................
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.._..._....._..............................................~...................
. . . . . . . . . . . . . . . . . .
(rear pane)) . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
,......
Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
._..............................................
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 63
.._..............__......_.......
,.......
.._,.
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. . . . . . . . . . . . . . . . . 82
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. . . . . . . . . . . . . . . . . . 86
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
63 64
66 66
:;
69 69
69
70
75
79
79
81
82 82
83
83
83 83 84 84 a5
86 86
86
89
a9 89
.I
,a
Page 5

Introduction

About the
DINAMAP@
DINAMAP
PRO Monitors provide noninvasive
PRO Monitor
determination of systolic blood pressure, diastolic blood
pressure, mean arterial pressure, pulse rate, temperature,
and oxygen saturation. These portable AC- and
DC- operated monitors are primarily intended for use in hospital acute care settings such as outpatient surgery, accident and emergency, labor and delivery,
Gl/endoscopy,
and medical/
surgical units.
The PRO
200, 300, and
9
PRO 100: BP and Pulse
l PRO 200: BP, Pulse, and Temp
. PRO 300: BP, Pulse, and
l PRO 400: BP, Pulse, Temp, and
Monitor comes in four different models: PRO 100,
400, all with printers.
SpO,
SpO,
All of the main operations of the PRO Monitor are easy to use. Please review the factory default settings and, where applicable, enter settings appropriate for your use. The “Using the Monitor” section of this manual explains how to use the Monitor in its most simple form, while the “Using the Menu System” section explains how to customize measurements by using the menu system.
lndica tions
The PRO Monitor is intended to monitor one patient at the bedside.
Contraindications
This device is not designed, sold, or intended for use except
as indicated.
Federal law (U.S.A.) restricts this device to sale by or on the
order of a clinician.
Warnings
. .
l Do not use the PRO Monitor in the
magnetic resonance imaging (MRI)
presence of
devices. There have been reports of sensors causing patient burns when operating in an MRI environment.
Page 6
l Do not use the Monitor in the presence of flammable
anesthetics.
l To help prevent unintended current return paths with
the use of high frequency (HF) surgical equipment, ensure that the HF surgical neutral electrode is properly connected.
l To avoid personal injury, do not perform any servicing
unless qualified to do so.
l WARNING: These Monitors should not be used on
patients who are connected to cardiopulmonary bypass machines.
. If powering the Monitor from an external power
adapter or converter, use only Critikon-approved power adapters and converters.
l The Monitor does not include any user-replaceable
fuses. Refer servicing to qualified service personnel.
l To reduce the risk of electric shock, do not remove the
cover or the back. Refer servicing to a qualified service person.
l If the accuracy of any determination reading is
questionable, first check the patient’s vital signs by alternate means and then check the PRO Monitor for
proper functioning.
Cautions
l Do not use replacement batteries other than the type
supplied with the Monitor. Replacement batteries are available from Critikon. See Appendix D.
l The PRO Monitor is designed to conform to
Electromagnetic Compatibility (EMC) standard IEC 601-l -2, 1993 and will operate accurately in conjunction with other medical equipment which also
meets this requirement. To avoid interference
problems affecting the Monitor, do not use the
Monitor in the presence of equipment which does not
conform to these specifications.
8-
Page 7
Introduction
Place the PRO Monitor on a rigid, secure surface.
Monitor must only be used with mounting hardware, poles, and stands recommended by Critikon. See
Appendix D.
The weight of the accessory basket contents should
not exceed 6.6 lb (3 kg).
Arrange the power cord, air hoses, and all cables
carefully so they do not constitute a hazard.
Verify calibration of BP parameter (temp and pulse
oximeter do not require calibration). Ensure that the display is functioning properly before operating the
PRO Monitor.
Do not immerse the Monitor in water. If the Monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth.
Do not gas sterilize or autoclave.
The PRO Monitor, when used with Critikon-approved
applied parts and accessories, is protected against defibrillator damage.
Notes
l Waveforms may be distorted and readings inaccurate
when electrosurgical cautery equipment is used while
monitoring
-
The electromagnetic compatibility profile of the PRO
with the PRO Monitor.
Monitor may change if accessories other than those specified for use with the PRO Monitor are used.
l Trend data are retained in the PRO Monitor when it is
turned off, except when the default is overridden by selecting the Trend button under the Service menu.
Page 8
Product Compliance
DINAMAP@
The
categories for compliance with
l Class l Transportable l For continuous operation
l Not suitable for use in the presence of flammable
I,
anesthetics
l Not for use in the presence of an oxygen-enriched
atmosphere (oxygen tent)
l Type BF applied parts
IPXl,
l
l Sterilization/Disinfection, see Appendix F
degree of protection against ingress of water
PRO Monitor is classified in the following
IEC
601-l :
internally powered
QD
@ C
DINAMAP@
us
PRO MONITOR
CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO.
.l
601
. ALSO EVALUATED TO IEC-601-2-30.
CC
0086
This product conforms with the essential requirements
of the Medical Device Directive. Accessories without the CE mark are not guaranteed to meet the Essential
Requirements of the Medical Device Directive.
10
Page 9

Getting Started

Unpacking the Monitor and Accessories
Before attempting to use the PRO Monitor, take a few minutes to accessories. Unpack the against the contents checklist enclosed in one of the accessory boxes. This is also a good
damage or shortage. If there is a problem or shortage, contact Critikon.
become acquainted with the Monitor and its
items carefully, and check them
time to check for any
It is recommended that all the packaging case the Monitor
must be returned for service in the future.
be retained, in
Power Sources
The PRO Monitor is designed to operate from either an
internal lead-acid battery, AC mains or an IEC 601-l compliant DC power source (see Appendix A).
replacement rechargeable batteries, please refer to the
Service
The Monitor contains five fuses. Two AC line input fuses
are mounted internally and are replaceable only by qualified service personnel. The remaining three fuses are resetable and mounted within the Monitor. These fuses protect the low voltage DC input, the battery, and the output on the host port connector.
section of this manual.
For
auto-
+5
Powering the Monitor
Before the PRO Monitor is used for the first time, the battery should be charged in the Monitor for at least 8 hours.
V
Refer to the illustration of the rear panel connections. Looking at the rear of the PRO Monitor, remove the battery compartment cover. Insert the rechargeable battery into the compartment so that the battery terminals fit into the power
clips at the bottom of the compartment. Then replace the cover. Insert the power cord plug into the mains external power socket (2) and plug into an AC outlet.
Refer to the illustration of the front panel controls and indicators. With mains or the green external power indicator LED (14) will light to indicate that external power is being applied and that the
battery is charging. If the battery is not inserted, the external
externat DC power connected,
Page 10
power indicator LED will flash (short flash approx. every 4
When the Monitor is running on battery
appears in
LCD area 3 (toggling with the time indicator)
power, a battery icon
set).
indicating the charge status.
During battery-only operation, the yellow battery power indicator LED (17) will light. When the battery becomes discharged beyond the low battery threshold, the indicator will begin to flash, and the Monitor will sound warning beeps every 30 seconds. At this point, the Monitor should be connected to an AC outlet to recharge the battery. If the
Monitor continues to be used without charging the battery, the message WARNING: THE
BAlTERY
IS TOO LOW FOR
MONITOR TO FUNCTION. TURN MONITOR OFF appears.
The Monitor shuts down all functions until it is turned off and the battery is recharged or replaced. To run the Monitor on AC power, it must be powered off and then on again.
Battery charging will take place as long as the Monitor remains
connected to an external AC power source. A battery that is fully discharged can be fully recharged in
1 hour 50 minutes
when the Monitor is switched off or 8 hours if the Monitor is switched on.
.,:
Notes
l To prolong the life of the battery, keep the Monitor
connected to an AC outlet whenever possible. NEVER allow the battery to become completely discharged. A
fully charged battery will power the Monitor for
approximately 2 hours and should survive between and 500 charge/discharge cycles. When it is necessary to replace the battery, refer to the “Compatibility Table and Reorder Codes” listed in Appendix D. To ensure full charge cycles, replace only with a recommended battery.
If the Monitor is to be stored for some time, first charge
the battery and then remove it and store it separately from
the Monitor.
9
For continued safety, use only a power cord of listed type
SJT, three-conductor, min. No. 18 AWG, terminated in a medical/hospital grade attachment plug, provided with the following cord tag:
“Hospital Grade Plug.” Grounding
200
14
Page 11
Getting Started
integrity can only be maintained when equipment is
connected to an equivalent receptacle marked “Hospital Grade.”
l Where the integrity of the external earth conductor in the
installation or its arrangement is in doubt, the Monitor
be operated from its internal battery.
General Caution
Do not touch either the pin of the DC input connector (3) or the terminals within the battery compartment (1) and the patient at the same time.
must
15
Page 12
**a
l
.:::::t:.
l
a**me*oe
l
53’
***e :gg::gp
Rear Panel
Battery compartment cover: Retains and protects
1
internal battery Mains input: Used to connect to AC power supply
2
External power
3
Critikon
Inactive temperature cable storage: Inactive temperature
4
probe cable attaches here (Models
Pole clamp: Used to clamp monitor to
5
Data interface connector: Host communications port
6
(15
way D-type RS-232 serial port) for use only with
Connections
socket: To be used with approved
AC-DC power converter ONLY
200
and
pole or stand
400)
equipment conforming to IEC 601-1, configured to comply with IEC 601-l-l
16
Page 13
Getting Started
15 16
17 18
I
I
Front Panel Controls and Indicators
7
Systolic pressure display:
measured systolic BP in
8
Active temperature probe holster: Temperature probe that is being used stored here (Models 200 and
9
Diastolic pressure display: 3-digit red LED indicates
measured diastolic BP
10 Temperature probe cover storage: Box of probe covers
stored here (Models 200 and 400)
11 Inactive temperature probe holster: Extra temperature
probe can be stored here (Models 200 and 400)
12 Temperature display: 4-digit red LED indicates measured
temperature (Models 200 and 400)
“F
display: Indicates whether temperature is being
“C
13
displayed in degrees Celsius or Fahrenheit (Models
400)
and
3-digit red LED indicates
mmHg
mmHg
in
400)
200
Page 14
14 External power indicator: Green LED indicates external
power status and battery charging status of monitor
15 Temperature probe connector: Temperature probe cable
attaches here (Models 200 and 400)
16
ON/OFF switch: Controls on/off state of monitor; push
for power on and push again for power off
17 Battery power indicator: Yellow LED indicates operation
and charge status of internal battery
18
SpOz
sensor connector:
SpOz sensor extension cable
attaches here (Models 300 and 400)
19 Mean arterial pressure display:
measured MAP in
mmHg
and shows instantaneous cuff
3-digit red LED indicates
pressure during BP determination
20
SpOz
pulse indicator: Yellow LED in heart symbol flashes to indicate that real-time pulse rate measurements are being derived from
SpOz
signals (Models 300 and 400)
21 Rotor: Used to highlight and select items in LCD
menus; if monitor is off, pressing rotor will switch monitor on
22 Pulse BPM display: 3-digit yellow LED shows pulse rate
in beats per minute
23
24
SpOz
display: in
% (Models 300 and 400)
SpOz
artifact indicator LED: Illuminates when motion
3-digit red LED indicates oxygen saturation
artifact is detected (Models 300 and 400)
25 LCD (liquid crystal display): Displays all alarms, user
interface messages, and configuration options
26 Alarm silence switch: Alternately mutes and enables
audible alarms; when pushed once after alarm sounds (silence
on), switch lights to indicate that audible alarms
have been silenced for 2 minutes
27 AUTO BP key: Press to start Auto BP mode 28 Light sensor: Automatically measures ambient light to set
LED display intensity
29 START/STOP BP key: Press to start or stop a BP, Auto,
Stat, or Vitals determination
30 Cuff connector: BP cuff hose attaches here
-18
.s>
Page 15
Getting Started
Switching the Monitor On and Off
@
To switch the
ON/OFF
As the Monitor powers up, it will run a short self-test
routine, which will flash all the indicator lights and then
beep the warning speaker. After a few seconds the system
will be ready for operation, as indicated by the appearance
of the main menu on the
To switch the Monitor off, push the power ON/OFF switch
(16) again. This will terminate any measurements that may
be in progress and automatically deflate the cuff.
When the Monitor is operating on the internal battery only, battery life is enhanced by the use of the sleep
However, the PRO Monitor will not enter sleep mode if an alarm is active. If no controls are used and no determinations are being made, the Monitor will enter sleep mode after a time which can be preset by the operator. All LED displays will be blanked except for a dash in the far-left systolic position, and any existing readings will be transferred to the LCD, which displays the message “Sleep Mode Active.” Moving the rotor or pressing a key will “wake up” the Monitor.
DINAMAP
switch (16) or press the rotor (21).
PRO Monitor on, push the power
LCD (25).
mode.
liquid Crystal Display (LCD)
MENU AREA
Menu Area
This area displays the name of the menu that has option
buttons available for selection. Normal text in the menu
area appears dark on a light background, while the text of
Page 16
selected buttons appears light on a dark background.
Note: Some menus have six option buttons. In these cases,
is no space available to display the menu
title.
Area 2
This area displays
l Source 1:
. Source 2: Last three BP readings
data
from one of three different sources.
SpO,
plethysmograph (Models 300 and 400)
. Source 3: Error and warning messages
Note: Refer to “Display Button” in the “Using the Menu System”
section for instructions on setting Area 2.
Area 3
This area displays the time, the time lapsed since the last Auto
BP determination
(if in Auto BP mode), the battery icon (if
operating on battery power, the time and battery icon toggle), and the BP and Printer
modes.
there
Using the Printer
Installing the Paper
Turn the PRO Monitor so that the side is facing you. While
grasping the side of the Monitor, firmly press the notched
indentations on the printer pop open. With the Monitor powered on, place the roll of paper into the compartment so that the end of the paper comes off the top, and thread it between paper touches the plates, the paper will begin to auto-feed itself into the printer. Feeding the end of the paper strip through the slot in the door, firmly press the notched indentation on the side of the printer door to close it. Use the paper release lever to clear a paper jam or manually feed the paper. Note: Make sure that the roll of paper is tightly wound.
door to open it. The printer door will
the two printer plates. As the
_
Page 17
Getting Started
Any time the paper is loaded, the printer automatically prints a test strip with the
visible on the paper, check that the paper roll
installed in the printout, use a slight sideways action to pull the paper sharply up across the serrated edge of the door.
Printer Alarms
If the Monitor is the printer door next to “PRNT” in Area 3 of the LCD. When new paper is installed and the printer door is closed, the message will change to “Manual” for Manual print or “Auto” for Auto print, depending on the status before the paper change.
If the paper runs out during a print request or if an attempt is made to print when no paper is installed, the message “Printer No Paper” will appear in Area 2 of the LCD and an audible alarm will sound. In addition, the message “No Paper” will appear next to “PRNT” in Area 3 of the LCD. To clear the alarm, press the rotor. The message in Area 3 of the LCD will remain until new paper is installed and the printer door is closed. (See “Using the Menu System.“)
the correct position (refer to diagram). To tear off
DINAMAP@
switched on with no paper installed or with
open, the message “No Paper” will appear
PRO name on it. If no print is
has been
-
Installing new paper will cause the Critikon header to be printed, thereby confirming that the paper is installed correctly and that the printer is operational. The message next to “PRNT” in Area 3 of the LCD will change to “Auto” or “Manual” to identify the operating mode of the printer. After power-off, the operating mode of the printer returns to the previous user-selected setting (Auto or Manual) unless specified otherwise in the Print button under the Service Button.
Storage
Store thermal paper in a cool, dry place. The printed strip (thermal paper recording) should not be
exposed
.
exposed to temperatures over 100 humidity over
.
placed in contact with adhesives, adhesive tapes, or plasticizers such as those found in all PVC page protectors.
to direct sunlight,
80%,
or
DINAMAP
“C
OF/38
PRO
or relative
Page 18
Note: When in doubt about long-term storage conditions, store a
photocopy of the thermal paper recording.
&ions
Ca
l The paper is thermally activated; therefore, do not store it in a
hot place as discoloration may result.
l Use only replacement paper rolls (58 mm) from Critikon.
i
22
Page 19

Using the Monitor

Noninvasive
Blood Pressure Determination
Description
The BP parameter is included in Models 100, 200, 300, and
400. Blood pressure is monitored noninvasively
in the
PRO Monitor by the oscillometric method, which measures
the amplitude of the pressure oscillations within the blood
pressure cuff. Further information about the oscillometric method is in Appendix C.
The PRO Monitor has four BP modes: 1. Manual,
2. Auto, 3. Stat, and 4. Vitals which is selected by the user, is
The
BP measurements are automatic, and once the cycle is complete the LED displays (7, 9, 19, 22) show systolic pressure, diastolic pressure, mean arterial pressure, and pulse rate.
Manual BP determinations are started by pressing the
1. START/STOP BP
key (29). In the Manual mode, the
(UK: All Obs). The mode,
shown on the LCD (25).
blood pressure is determined one time.
Auto BP determinations are started by selecting the
2. AUTO BP key (27) or the Auto button under the Set
(UK: BP
Mode) button in the Main menu.
When Auto mode is selected, a number at the right of
the Auto button indicates the time interval between each
reading. To change the time interval, choose the box around the number and turn the rotor until the desired interval is reached. The interval can be set between and 120 minutes (1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45, 60,
90, and 120 minutes).
Press the rotor to confirm the
setting.
Stat determinations are started by selecting the Stat
3.
button under the Set BP button
(UK: BP Mode) in the Main menu. In the Stat mode, the blood pressure is determined as many times as possible in
Vitals (UK: All Obs) determinations are started by
4.
5
minutes.
selecting the Vitals (UK: All Obs) button in the Main menu. (Refer to the “Using the Menu System” section.) Selection of this button initiates a BP determination
BP
1
?-%
F
h
23
Page 20
SpOz
while allowing
and predictive temperature determinations to be monitored and recorded (depending on Monitor model). In the Vitals (UK:
All
Obs) mode, the blood pressure is determined one time.
Before
to ensure that the cuff pressure
each BP determination, the Monitor performs a test
is below a specified level.
The determination is delayed until this condition is met.
During the delay, the
BP values are displayed as zero.
The Monitor senses the type of hose being used and
automatically uses adult/pediatric monitoring parameters or neonatal monitoring parameters, as appropriate.
Audible and visible alarms occur when a value for systolic pressure, diastolic pressure, mean arterial pressure, or pulse rate is outside the selected high or low limit.
Instructions for cleaning and disinfecting BP cuffs are in
Appendix F.
Genera/ Warnings
l The PRO Monitor will not measure blood pressure
effectively on patients who are experiencing seizures or tremors.
l Arrhythmias will increase the time required by the
PRO Monitor to determine a blood pressure and may extend the time beyond the capabilities of the Monitor.
l In Manual mode, the PRO Monitor displays the results
of the last blood pressure determination for 2 minutes or until another determination is completed. If a patient’s condition changes between one determination and the next, the Monitor will not detect the change or indicate an alarm condition.
l
Devices that exert pressure on tissue have been
associated with purpura, skin avulsion, compartmental syndrome, ischemia and/or neuropathy. To minimize these potential problems, especially when monitoring
at frequent intervals or over extended periods of time, make sure the cuff is applied appropriately and
-24
Page 21
Using
the Monitor
examine the cuff site and
the limb distal to the cuff
regularly for signs of impeded blood flow.
.
Do not apply external pressure against cuff while
monitoring. Doing so may cause inaccurate blood pressure values.
l Use care when placing cuff on extremity used to
monitor other patient parameters.
l The PRO Monitor is designed for use only with
dual-
tube cuffs.
l Use only accessories recommended by Critikon.
Failure to use recommended accessories may result in inaccurate readings. See Appendix D.
l Blood pressure cuffs should be removed from the
patient when the Monitor is powered off. If the extremity remains cuffed under these conditions or if
the interval between blood pressure determinations is
prolonged, the patient’s limb should be observed
frequently and the cuff placement site should be
rotated as needed.
General Cautions
.
Accuracy of BP measurement depends on using a cuff
of the proper size. It is essential to measure the circumference of the limb and to select the proper size cuff. The air hoses are color-coded according to size of the patient. The gray m or 7.3 m) is required on patients who require cuff sizes from infant through thigh cuffs. The teal green)
neonatal cuff sizes
.
If it becomes necessary to move the cuff to another
12-foot
hose (3.66 m) is required for the
#l
through
limb, make sure the appropriate size cuff is used.
.
The pulse rate derived from a BP determination may
differ from the heart rate derived from an EKG
waveform because the PRO Monitor measures actual
peripheral pulses, not electrical signals or contractions from the heart. Differences may occur because electrical signals at the heart occasionally fail
12-
or
24-foot hose (3.66
#5.
(blue-
Page 22
to produce a peripheral pulse or the patient may have
poor peripheral perfusion. Also, if a patient’s
beat-to-
beat pulse amplitude varies significantly (e.g., because
atrial
of pulsus alternans,
fibrillation, or the use of a rapid-cycling artificial ventilator), blood pressure and pulse rate readings can be erratic, and an alternate measuring method should be used for confirmation.
General Notes
l A patient’s vital signs may vary dramatically during the
use of cardiovascular agents such as those that raise or
lower blood pressure or those that increase or decrease heart rate.
9
Because treatment protocols based on the patient’s
blood pressure may
measurement methods,
rely on specific values and differing
such as auscultatory, clinicians
should note a possible variance from values obtained
with the PRO Monitor
management. the oscillometric method of noninvasive blood pressure measurement and correspond to comparisons
inn-a-aortic
The PRO Monitor values are based on
values within ANSI accuracy (a mean difference of standard deviation of
in planning patient care
+
8
/AAMI
mmHg).
Standards for
mmHg, and a
+ 5
with
. Several conditions may cause the
calculate and display
only the mean arterial pressure
BP parameter to
(MAP) without a systolic and diastolic reading. These conditions include very low systolic and amplitude
fluctuations, so an accurate calculation for these values
can’t be made (e.g., patient in shock); too small of a difference between systolic and MAP calculations in relationship to the difference between diastolic and MAP; or a leak has occurred in the
(1.
Check all BP connections 2. Monitor may need
PRO Monitor
calibration and leak testing). If only the MAP value is
displayed, the systolic and diastolic will display dashes (-) and an alarm message
displayed.
“N99-BP
FAILED” will be
26
Page 23
Using the Monitor
Procedures
Connect the end of the air hose which has quick-release
1. clips to the cuff connector (30) on the front of the Monitor. Make
Note: To
the quick-release clips together and pull the plug from the cuff connector (30). Select the appropriate blood pressure measurement site.
2. Because normative values are generally based on this site and as a matter of convenience, the upper arm is preferred. When upper arm size or shape, the patient’s clinical condition, or other factors prohibit use of the upper arm, the clinician must plan patient care accordingly, taking into account the patient’s cardiovascular status and the effect of an alternative site on blood pressure values, proper cuff size, and comfort. The figure shows the recommended sites
for placing cuffs.
Warning: Do not place the cuff on a limb being used for intravenous infusion or any area where circulation is compromised or has the potential to be
sure that the hose is not kinked or compressed.
disconnect the hose from the Monitor, squeeze
compromised.
I
mmHg
Neonate
from values for
Adult/Pediatric
3.4.If patient is standing, sitting, or inclined, ensure that cuffed limb is supported to maintain cuff at level of patient’s heart. If cuff is not at heart level, the difference in systolic and diastolic values due to hydrostatic effect must be considered. Add cm) above heart level. Subtract every inch (2.54 cm) below heart level. Select appropriate cuff size. Measure patient’s limb and select appropriately sized cuff according to size marked on
cuff or cuff packaging. When cuff sizes overlap for a
specified circumference, choose the larger size cuff.
Precaution: Accuracy depends on use of proper size cuff.
1.80
mmHg
to values for every inch (2.54
1.80
f
Page 24
5.
Inspect cuff for damage. Replace cuff when aging, tearing, or weak closure is apparent. Do not inflate cuff when unwrapped.
Precaution: Do not use cuff if structural integrity is
suspect.
6.
Connect the cuff to the air hose. Thread the cuff connectors onto the hose connectors until finger tight.
Do not overtighten.
Warning: It is mandatory that the appropriate hose and
cuff combination be used. Any attempt to modify the hose will inhibit the Monitor from switching between
the neonatal and adult measurement modes.
Note: In normal use, each cuff will have its own hose, so
it will not usually be necessary to disconnect them. If it is
necessary to do so, carefully unscrew the cuff from the hose. Care should be taken in reconnecting the cuff to a hose, ensuring that threads of the cuff and hose are in alignment and no cross-threading occurs.
Inspect patient’s limb prior to application.
7. Precaution: Do not apply cuff to areas where skin is not
intact or tissue is injured. Palpate artery and place cuff so that patient’s artery is
8.
aligned with cuff arrow marked “artery.”
Squeeze all air from cuff and confirm that connection is
9.
secure and unoccluded and that tubing is not kinked.
1 O.Wrap cuff snugly around the patient’s limb. Cuff index
line must fall within the range markings. Ensure that hook and loop closures are properly engaged so that pressure is evenly distributed throughout cuff. If upper arm is used, place cuff as far proximally as possible.
11
.Proper cuff wrapping should be snug, but should still
allow space for a finger between patient and cuff. Cuff should not be so tight as to prevent venous return between determinations.
Warning: Using a cuff that is too tight will cause venous congestion and discoloration of the limb, but
using a cuff that is too loose may result in no readings and/or inaccurate readings.
12.Proceed with monitoring in the Manual, Auto, Stat, or Vitals (UK: All Obs) mode.
28
Page 25
Using the Monitor

Manual Mode

@
To start a determination, press the START/STOP BP key (29). A
normal, uninterrupted Manual cycle takes about 40
seconds.
(neonate) or 15 determination can be started.
displayed
determination is started within that time frame. This applies
to Manual and Vitals (UK:
the operating
The default setting of Manual can be overridden to return to
the previous user-selected setting (Auto or Manual) by selecting Set
Note: The START/STOP BP key is an on-off switch; pressing it will stop any BP determination (Manual, Auto, Stat, or
Vitals) that is in progress.
The cuff pressure must drop below 5
mmHg
for 2 minutes on the LED unless another
mode returns to the default setting of Manual.
BP (UK: BP Mode) under the Service menu.
(adult) before another
BP information will be
All Obs) modes. After power-off,
mmHg

Auto Mode

&Z?)
Auto BP determinations are started by selecting the AUTO BP key (27) or the Auto button under the Set BP button (UK: BP Mode) in the Main menu.
Selecting the AUTO BP key (27) brings up the Set BP menu (UK: BP Mode) and automatically starts an Auto BP
determination as long as the Monitor is in Manual BP mode.
If the Monitor is already in Auto BP mode, selection of the
AUTO BP key (27) brings up the Set BP menu (UK: BP
Mode) without starting a new determination until the preset time interval has expired. Pressing the START/STOP
during
determination in progress. When Auto mode is selected, a number at the right of the
Auto button indicates the time interval between each
reading. To change the time interval, choose the box around
the number and turn the rotor until the desired interval is
reached. The interval can be set between minutes (1, 2, 3, 4, 5,
a series of Auto BP determinations will cancel the
1 and 120
10, 15, 20, 25, 30, 45, 60, 90, and
BP key
29
Page 26
120 minutes). Press the rotor to confirm the setting. After power-off, the operating mode returns to the default
of Manual.
The default setting of Manual can be overridden
to return to the previous user-selected setting (Auto or
Manual) by selecting Set BP (UK: BP Mode) under the
Service menu.
setting
In the Auto mode, the pressure must be below 5
(neonate) or 15
mmHg
(adult) for at least 30 seconds
mmHg
before another determination can be started. BP
information will be displayed on the LED until the next determination is started. This applies to Auto
mode only. Note: To cancel an Auto BP determination, select the Manual button in
the Set BP menu (UK: BP Mode).

Stat Mode

Multiple the Stat button under the Set
BP readings can be taken at any time by selecting
BP button (UK: BP Mode) in
the Main menu. Stat mode can also be accessed by pressing the AUTO
BP key (27) and then selecting the Stat
button when the Set BP menu (UK: BP Mode) appears.
If a Manual determination is not in progress, a S-minute
series of determinations will start. If a Manual determination is in progress, that determination will become the first in the
series. A normal, uninterrupted Stat sequence will give the first set of systolic, diastolic, and mean arterial pressure values and pulse rate within
15
to
20
seconds. Selecting the
Stat button during a series of Stat determinations will cancel
the determination in progress and the rest of the series. BP information will be displayed on the LED until the determination has been canceled or completed. This applies
to Stat mode only. The series begins with cuff inflation to a pressure above the
previous systolic pressure or, if no previous systolic value is stored, to approximately 160
mmHg
for adult/pediatrics.
The initial target pressure selection for neonates is 110
mmHg.
Artifact rejection is relaxed in the Stat mode for
adult/pediatric patients to allow for accelerated determinations. If a BP or Stat reading has been made previously, the first new systolic value will flash
display (7) within
a few seconds and will continue to flash
on the LED
until the end of the determination. At that point a short tone
will sound and the updated systolic, diastolic, and mean
30
t;
Page 27
Using the Monitor
arterial pressures and pulse rate will appear on their LED displays (7, 9, 19, 22).
determination once the pressure is
seconds (neonates) or 15
unless the S-minute period has ended or the determination
has been canceled. Note: Alarm limits are disabled while in Stat mode.
The Monitor will begin another
mmHg
mmHg
below 5
for 4 seconds (adults),
for 8
Predic
Tempera ture De termina tion
five
Q
Description
The temperature parameter is included in Models 200 and
400. The PRO Monitor uses used with both oral and rectal temperature probes. Two modes of operation are available: predictive and monitor.
In predictive mode, a final temperature is displayed with an audible tone. In monitor mode, the display is updated continually as the patient’s temperature rises or falls. Note: If the PRO is unable to complete a predictive determination, then it enters monitor mode. These temperature readings are not stored in trends and not reported via host
During a temperature determination, the temperature display indicator. In the far-left position, a single horizontal line indicates the probe is ready to start a determination after removal from the probe holster. In the far-right position of
the temperature display, a “chase sequence” around the
outside space indicates a predictive temperature determination is in progress. During monitor mode, the
temperature readings flash constantly.
(12) provides a progress meter and probe ready
comms.
IVAC*
technology and can be
Temperature is shown on the temperature display in
degrees Celsius or Fahrenheit, and the unit of measure is
indicated by the
Celsius, can be changed in the Clinician Menu (please refer to the “Using the Menu System” section of this manual).
*IVAC
is a trademark of
“F
display (13). The default, which is
“C
Alaris
Medical Systems
Page 28
General Warning
l The performance of the Monitor may be degraded if it
is operated outside of the environmental conditions specified in Appendix A.
General Cautions
l Be careful not to overextend the coiled cord of the
temperature probe. Overextension can damage the probe coil connector interfaces.
l Accurate oral temperatures (blue) can only be
obtained by placing the probe under the tongue in the
right or left sublingual pocket. Temperatures in other
locations in the mouth can vary by more than 2
OC.
1
l Accurate rectal temperatures can only be obtained by
using the red temperature probe. Red and blue temperature probes are
not
interchangeable.
OF
or
l Do not allow the tip of the predictive temperature
probe to come into contact with a heat source (e.g., hands or fingers) prior to taking a temperature
determination. If this occurs, allow
5
seconds for the
probe tip to cool before proceeding.
l Use only
IVAC*
probes and probe covers. The size, shape, and thermal characteristics of the probe covers can affect the performance of the instrument.
Inaccurate readings or retention problems may occur
unless
IVAC probes and probe covers are used.
Procedures
1.
Connect the temperature probe cable to the temperature probe connector (15).
2.
Remove the temperature probe from the probe holster. Place a protective temperature probe cover on the probe and insert the probe appropriately.
The determination begins automatically.
3.
Hold the temperature probe steady until the determination is complete. This takes approximately 60 seconds, during
which time a pattern of lines on the temperature display
(12) appears as a “chase sequence” to indicate progress.
*IVAC
is a trademark of
Alaris
Medical Systems
32
Page 29
Using the Monitor
When the determination is complete, an audible tone
sounds and the temperature appears on the display. Record the temperature and
4.
the disposable cover by holding the probe as you would
a syringe and pressing the button on the probe handle. Place the probe probe in the probe holster, the temperature values will
in the probe holster. Once you place the
be cleared.
Notes
l
If the probe tip temperature is 94.0” F or higher
(34.4” thermometer will not be able to perform a predictive measurement. Instead, the thermometer will automatically go
C) when taken out of the probe holster, the
into monitor mode. The temperature reading will then flash. A correct final temperature reading may require 3 minutes or longer. will not beep at final temperature. It will continue to monitor the patient’s temperature until the probe is removed from the patient and returned to the probe holster.
l
To cool the temperature probe down, wipe with alcohol.
l
If there is a long delay from the time the probe is removed from the probe holster until it is inserted into the patient’s mouth, it is possible that the instrument will not display a final temperature. probe into the probe holster, remove it again, and start a new measurement.
-
If an alarm is actively sounding, an audible tone will not
sound.
l
If tissue contact is lost, the chase sequence on the
temperature display
(12) stops. If tissue contact is not
made within 1 minute, the Monitor will alarm.
remove the probe. Discard
Th.e
Monitor
If this occurs, insert the
Page 30
spa,
Description
SpOz
The begin
the patient’s finger; monitoring begins automatically.
Functional oxygen saturation noninvasively and continuously monitored
PRO Monitor using pulse oximetry technology from
NELLCOR*. Functional hemoglobin to hemoglobin that is capable of transporting oxygen. This ratio, expressed as a percentage, is shown on the
SpOz
Heart rate derived from display synchronization
that are derived from the
rate corresponding to the pulse rate and at a pitch
corresponding to the
highest at 100% oxygen saturation, and it the saturation level falls. The Monitor can display a pulse
amplitude bar and a plethysmographic waveform on the
LCD (25). The pulse amplitude bar graph is proportional to the arterial blood flow. The artifact indicator LED (24) lights continuously when the Monitor detects motion sufficient enough to affect readings.
parameter is included in Models 300 and 400. To
SpOZ
SpOz
monitoring, simply place the
(SpOJ
of arterial blood is
sensor on
in the
SpOz
is the ratio of oxygenated
(23),
display
(22),
and the
which is continually updated.
Sp02
appears in the Pulse BPM
SpOz pulse indicator (20) flashes
with the real-time pulse rate measurements
SpOz
signal. A tone sounds at a
SpOZ
saturation level. The pitch is
becomes lower as
Audible and visible alarms occur when
SpOz:
levels are outside the alarm limits. When a limit alarm occurs, a message appears in Area 2 of the LCD display.
If you select the Alarms button, the Alarms menu appears.
This menu is used to adjust the violation limits for BP and
SpOz.
Refer to “Alarms Button” in the “Using the Menu
System” section.
*NELLCOR is a trademark of Mallinckrodt,
Inc.
34
Page 31
Using the Monitor
SpOz
If you select the Suspend button, the
for 2 minutes and
then the PRO returns to normal
monitoring. A message informing the user that
suspending appears
LED while the Selecting Cancel
return to monitoring
in Area 2 and dashes appear in the
Sp02
alarm suspend is counting down.
will cancel the
Sp02.
SpOz
Low
SpOZ
is suspending
alarm is suspended
alarm suspension and
Sp02
SpOz
is
SpOz
2:oo
ICancel
If the Monitor is unable to detect a pulse for 10 seconds during normal
SpOz
monitoring, the values in the LED flash, alternating patient values with dashes. The Monitor returns to normal
SpOz
reporting of values when several consecutive
good pulse determinations are made.
Genera/ Warnings
SpOZ
l Do not use the
resonance imaging (MRI). Adverse reactions include potential burns to patients as a result of contact with attachments heated by the MRI radio frequency pulse,
potential degradation of the magnetic resonance image, and potential reduced accuracy of Always remove oximetry devices and attachments from the MRI environment before scanning a patient.
function during magnetic
SpOZ
measurements.
l The use of cardio-green and other intravascular dyes at
certain concentrations may affect the accuracy of the
SpOZ
measurement.
SpOZ
l The
function is calibrated to read functional arterial oxygen saturation. Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin may affect the accuracy of the
measurement.
General Cautions
l
As with any clip-on sensor, pressure is exerted. The
clinician should be cautious in using a clip-on sensor on
SpOZ
Page 32
patients with compromised circulation (e.g., because of
peripheral vascular disease or vasoconstricting medications).
l Do not perform any testing or maintenance on a sensor
while it is being used to monitor a patient.
.
Bright light sources (e.g., infrared heat lamps, bilirubin lights, direct sunlight, operating room lights) may interfere
with the performance of the such interference, cover the sensor with opaque material.
SpOZ
function. To prevent
General Notes
.
A patient’s vital signs may vary dramatically during the use of
cardiovascular agents
pressure
l The PRO Monitor is compatible only with NELLCOR sensors. l Software development, software validation, and Risk and
or those that increase or decrease heart rate.
Hazard Analysis has been performed to a registered quality
system.
Procedures
1. Select a sensor that is appropriate for the patient and the
clinical situation.
Warning: Do not use a damaged sensor or one with exposed electrical contacts.
Note: Use only NELLCOR sensors, which are available
from:
such as those that raise or lower blood
_,
.
I
>T
,
_,
USA
UK
Mallinckrodt, Inc. 675
MacDonnell
Blvd PO Box 5840 St. Louis, MO 63
Phone: 1-800-NELLCOR (USA) Fax: l-888-222-9799
134
Nellcor
10 Talisman Business Center
London Road Bicester
Oxfordshire
0X6-OJX
UK Phone: 44-189-632-2700
1
Page 33
Using the Monitor
Following the directions for use supplied with the sensor,
2
apply the sensor to the patient.
Warnings
Patient safety:
If you fail to apply the sensor properly, the patient’s skin could be injured or the ability of the PRO
Monitor to measure oxygen saturation could be
compromised, For example, a clip-on
never be taped shut. Taping the sensor could damage
the patient’s skin or impair the venous return, thus
causing venous pulsation and inaccurate measurement of oxygen saturation.
Excessive pressure from the sensor may cause necrosis
of the skin.
Monitor performance:
SpOZ
When an
pressure cuff, the
the cuff is inflated. If
sensor is on a limb that has a blood
SpOZ
data will not be valid when
SpOZ
readings are required during the entire blood pressure determination, attach the
SpO, sensor to the limb opposite the one with the
blood pressure cuff.
sensor should
Remove nail polish and artificial nails. Placing a sensor
on a polished or an artificial nail may affect accuracy.
Cautions
Patient safety:
Do not place any clip-on sensor in a patient’s mouth
or on a patient’s nose or toe.
Do not place a clip-on finger sensor on a patient’s
thumb or across a child’s foot or hand.
Observe the sensor site to assure adequate distal
circulation.
Monitor performance:
l For best performance, place the sensor at heart level.
l Placing a sensor distal to an arterial line may interfere
with adequate arterial pulsation and compromise the
measurement of
SpOZ.
37
Page 34
LEDs
l Place the sensor so that the
and the photodiode are
opposite each other.
SpOz
Plug the
3.
Then plug the
sensor into the
SpOZ
sensor extension cable into the
Sp02 sensor extension cable.
sensor connector (18).
SpOz
Proceed with monitoring.
4.
determinations run
continuously and can run simultaneously with other
measurements.
SpOz
. .
.;
,
38
Page 35
Using the Monitor

Troubleshooting

This section discusses potential difficulties and suggestions for
resolving them. If the difficulty persists, contact a qualified service person or your local Critikon representative.
The service manual, which is for use by qualified service personnel
provides additional troubleshooting information. PROBLEM: The pulse amplitude bar indicates a pulse, but no
oxygen saturation or pulse rate values appear on the screen.
CAUSE:
l Excessive patient motion may be making
SpOz
function to find a pulse pattern.
l The sensor may be damaged. l The patient’s perfusion may be too low to allow the
it impossible for
function to measure saturation and pulse rate.
SOLUTION:
Check the patient.
l If possible, keep the patient still; check whether the
sensor is applied securely and properly, and replace it if necessary; move the sensor to a new site; or use a disposable adhesive sensor that may tolerate more motion.
l Replace the sensor.
SpO2
PROBLEM: The
value or the pulse rate changes rapidly; the
puise amplitude bar is erratic.
CAUSE:
the
SpOz
SpOz
.
Excessive patient motion may be making it impossible for the
SpOz
function to find a pulse pattern.
l An electrosurgical unit (ESU) may be interfering with
performance.
SOLUTION:
Check the patient.
l If possible, keep the patient still; check whether the sensor is
applied securely and properly, and replace it if necessary; move the sensor to a new site; use a sensor that tolerates more motion.
Y-
i
LI
39
Page 36
ESU
If
an
l Move the l Plug the Monitor and the ESU into different AC circuits. l Move the ESU ground pad as close to the surgical site as
is interfering:
SpOz
cable as far from the ESU as possible.
possible.
0
The sensor may be damp or may need to be replaced with a
new
sensor.
l If the patient weighs less than 3 kg or more than 40 kg, apply
an
OXISENSOR
N-25 oxygen transducer to an appropriate site. This sensor has added protection against electrosurgical interference.
PROBLEM: The oxygen saturation measurement does not correlate with the value calculated from a blood gas determination.
CAUSE:
l The
Sp02 calculation may not have correctly adjusted for the
CO,;
effects of
fetal hemoglobin; or pH; temperature;
DPG.
l Accuracy can be affected by incorrect sensor application or
use; intravascular dyes; bright light; excessive patient movement; venous pulsations; electrosurgical interference; and placement of a sensor on an extremity that has a blood pressure
cuff, arterial catheter, or intravascular line.
SOLUTION:
l Check that calculations have been corrected appropriately for
the relevant variable. In general, calculated saturation values are not as reliable as direct laboratory hemoximeter measurements.
l If there is excessive light, cover the sensor with opaque
material.
l Circulation distal to the sensor site should be checked
routinely. The site must be inspected every
8 hours to ensure
adhesion, skin integrity, and correct optical alignment. If skin
integrity changes, move the sensor to another site.
2,3-
-40
Page 37
l Try to keep the patient still, or change the sensor site to one with
less motion.
l Observe all instructions, warnings, and cautions in this manual
and in the directions
PROBLEM: A valid
for use of the sensor.
SpO2
signal was present but has disappeared.
CAUSE:
l A BP determination on the same limb is in progress.
SOLUTION:
l An alarm message (No signal) will appear on the screen, and the
audible alarm will sound immediately.
occurred.
PROBLEM: A bad signal error
has
CAUSE:
l Weak or “noisy” signal.
SOLUTION:
Check the patient.
. If possible, keep the patient still; check whether the sensor is
applied securely and properly, and replace it if necessary; move the sensor to a new site; or replace the sensor.
l Change sensor type. l Consider increasing perfusion using heat. l If there is excessive light, cover the sensor with opaque material.
PROBLEM: A sensor error indicating a bad sensor has occurred. CAUSE:
l The sensor or cable may be defective, or the cabling may be
improperly connected.
SOLUTION:
Check the patient.
l If possible, keep the patient still; check whether the sensor/cable
is applied securely and properly, and replace it if necessary.
l Disconnect and reconnect the sensor.
41
Page 38
L

Using the Menu System

Introduction
The PRO Monitor is equipped with a liquid crystal display
(25) and a rotor (21). Used together, these allow the
operator to view and edit most of the Monitor’s parameters
and functions. When the Monitor is in use, a number of
option buttons appear on the liquid crystal display (LCD).
The model of the Monitor determines which menu option
buttons appear on the LCD. The number of buttons and the
specific options depend on the menu level. The rotor
provides the means of choosing menu options and
changing monitor
Liquid Crystal Display
The LCD is divided into three areas, each of which distinct function.
MENU AREA
settings.
has a
AREA 3
Menu Area
This area displays the menu buttons that are available for selection. Normal text in the menu area appears dark on a light background, while the text of selected buttons appears light on a dark background.
Area 2
This area displays BP and
messages. The Display
data to be displayed.
Area 3
This area displays the time, the time lapsed since the last Auto BP determination (if in Auto BP mode), the battery
icon (if operating on battery power, the time and battery icon toggle), and the BP and printer modes. Note: In updates on the LCD can be delayed by approximately
second. This delay on the LCD does not affect the
performance of the Monitor.
cold ambient temperatures (below 50
Sp02 data and error and warning
mode menu is used to select the
10”
/ OF
C),
1
Page 39

Menu Tree

SYS
DIA
1
Stat
)
MAP BPM
Display
1
Main
1
1
POWER SAVE MENU
r’
L
SpO2
TIME
SYS
,I:37
___
,,:a2
c +
___ ___
,,:q
,,:S2
__ _
_ _
DIA
-__
__ _ __
_.
MAP BPM
-_-
_--
__-
__ _
-- _
--- ---
__- --- ---
TEMP
.,
-- _ __
-- - -- -
-- -
-- -
.._
r
Page 40
_
Using the Menu System
Menu Tree
ROTOR BEEP
Automaticalley
Restore Print mode on power-up?
I
Restore BP mode on power-up?
Enter
Clear Trend on Power-up?
alarm configuration mode?
Set
I
24-Aug-1999
Day
Mon
Yew
I999
14-J&
pi-,,
How
.
20: 21 11
Min
Notes
l
The
model of the Monitor determines which menu option buttons appear on the LCD.
45
Page 41
Rotor
Rotating the rotor causes option buttons to be highlighted (light text on a dark background). Turning the rotor
produces a click. Turning it clockwise moves the highlighting clockwise over the available buttons, while
turning it counterclockwise
highlighting. Pressing the rotor selects the highlighted button and produces an audible tone.
Some menus (e.g., Alarms) contain values that can be changed by the operator. After the value is highlighted, the
reverses the direction of the
user selects it by pressing the rotor. Turning the rotor
clockwise will cause the value to increase, and turning the
rotor counterclockwise will cause the value to decrease. Pressing the
rotor again will confirm the changed value.
Menu Tree
a//
The menu tree on the previous page shows
choices available within the menu structure, from the top
level
downward.
possible
Main Menu
This menu is the top level menu. It is displayed when the
Monitor is first switched on and after the rotor has been inactive for
(Pwr Sav).
2 minutes, unless the Monitor is in sleep mode
46
Page 42
-
Using the Menu System
Vitals Button (UK: All Obs)
Selection of this button initiates a BP determination while allowing be monitored and recorded (depending on Monitor model). When the Vitals determination is complete, a single “warble” sounds and all patient data are displayed on the held for 2 minutes or until cleared by the user. The shows:
Notes
l If the Monitor is performing a Vitals determination, the
SpO,
and predictive temperature determinations to
Values Held
Note:
If the
mode, the Print button does not
appear as an option.
Vitals button cannot be selected.
printer is in “Auto”
LEDs
LCD
and
l If a BP determination is in progress, the Vitals button
cannot be selected.
l A Vitals determination is canceled if the BP determination
is canceled.
. A Vitals determination can be canceled by pressing either
the AUTO
l During the 2 minute freeze period,
BP or START/STOP key.
SpO, monitoring and
alarms are suspended.
Clear
Selection of this button halts measurements and returns the user to the Main menu.
Note: If the
the waveform pauses
selected.
SpO, plethysmograph is displayed on the LCD,
for 2 minutes or until the Clear button is
SpO,values are also retained the same manner as
the BP and Temperature values.
Print
Selection of
this button causes the current data to be printed.
Page 43
Notes
l The Print button appears only when Print is set to Manual
mode.
. If
the printer is in Auto print mode, the data will be printed
automatically.
More... Button
Selection of this button displays the More... menu. The More...
menu has six options (depending on model of Monitor), most of
which have submenus.
For this reason, instructions for the More...
button are in a separate section.
Set BP Button (UK: BP Mode)
Selection of this button displays the Auto, Stat, and Manual BP menu.
Auto BP
Manual
Tgt
Pressure
Auto
Selection of this option starts an
Auto BP determination. When
Auto Mode is selected, a number at the right of the Auto button indicates the time interval between each reading. To change the time interval, choose the box around the number and turn the rotor until the desired interval is reached. The interval can be set between
60, 90, and 120 minutes).
1 and 120 minutes (1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45,
Press the rotor to confirm the setting.
After power-off, the operating mode returns to the default setting
of Manual. The default setting of Manual can be overridden to return to the previous user-selected setting (Auto or Manual) by selecting Set BP under the Service menu. To cancel an Auto BP
determination, select the Manual button in the Set BP (UK: BP Mode) menu.
Manual
Selection of this option starts a Manual BP determination. After power-off, the operating mode returns to the default setting of Manual. The default setting of Manual can be overridden to return to the previous user-selected setting (Auto or Manual) by selecting Set BP under the Service menu.
-48
Page 44
B
Using the Menu System
Tgt
Pressure
Selection of this option allows the user to set the BP target inflation pressure.
between 100 and 250 factory default is 160
neonates. (This is indicated by “AUTO” at the end of adjustable range.) When using a neonate blood pressure cuff, if the target pressure is set to greater than the Set BP or Clinical menu, the Monitor automatically defaults to a target pressure of 110 pressure is set between 100 and 140 is the target pressure that will be used. When the target pressure is changed, the next determination will use the new target inflation value if no systolic is available. Initial target
pressure is restored to the factory default
power-off.
in the Clinician menu of the Service mode (refer to “Press” in the “Using the Menu System” section).
The target pressure can be adjusted permanently
The initial target pressure can be set
mmHg
mmHg
mmHg
in 5
for adults and 110 for
mmHg. If the target
increments. The
mmHg
140
mmHg, then that setting
setting after
under
stat
Selection of this option allows the user to start Stat determinations. When Stat is selected, blood pressure is determined as many times as possible in
Note: Alarm limits are disabled while in Stat mode.
Main
Selection of this button returns the user to the Main menu.
Alarms Button
Selection of this button displays the Alarms menu. This
menu is used to adjust the violation limits for BP, Pulse Rate, and
SpO,.
not stored when the Monitor is turned off. The
edit the limits, but they are restored to the default values
each time the Monitor is switched on. To permanently change the alarm limits, refer to “Alarms” under “Service Button” in the “Using the Menu System” section.
The values and ranges for these parameters are
5
minutes.
user may
Page 45
SYS
DIA MAP
BPM
spoz
Kl
cl
FF
90
___.
1
Auto
/
.._.. . . .
j I
I
_._----
_--
Default
---
180
30
40
Off
Parameter
Systolic High Systolic Low Diastolic
Heart Rate
L
SpO2
spo2
Hiah
High
Low
130
cl
cl
15
Lo\
140
cl
cl
I /
, /
50
Range
245-.-~..-
_
35
-
240
30 15
-
195
-
245
30
51-100
-
99 90
50
Volume
Selection of this button displays the alarm volume submenu. The volume range is from 1 to 10, with 10 being the
loudest. The alarm volume is stored when the Monitor is turned off and restored to the user’s preference each time the Monitor is switched on. Selection of the Check button allows the current volume setting to be heard. Selection of the Main button returns the user to the Main menu.
1
--
,.
J
.
A
_,I
IL,
_>
ALARM VOLUME
Main
I
Auto
Selection of this button updates the alarm limits on the LCD
relative to the current parameter values. Pressing this button
will automatically cancel any limit violation alarm that
becomes invalid as a result of a limit change. Alarm limits
are updated as follows:
50
I
Page 46
I
Using the Menu System
1
Parameter Label
Systolic Diastolic
MAP Heart Rate span
1
*
If the reading plus the limit is greater than the valid range of measurement (e.g.,
is greater than 100%
Notes
.
In no case will the updated alarm limits be set beyond
the valid limits
l If no values are available, the limits will remain
unchanged.
),
Label
SYS
j
DIA
MAP BPM span
the valid range of measurement becomes the limits.
in the preceding table.
High Limit
+30SYS
DIA
MAP BPM spo2
+30 +30 +30
+5*
Low Limit
SYS
DIA -30 MAP -30 BPM -30 spo2 -5
SpO2
Main
Selection of this
button returns the
user to the Main menu.
Trend Button
Selection of this
button displays the Trend mode menu.
-30
+5
(
Display
I
1
1
Print All
Clear
1
I
Display
Selection of this button allows the operator to view the
trend data.
Note:
settings have been changed), the message “Trend Empty”
If the trend data have been lost (e.g., if the clock
will appear instead of the Newer, Older, and Print page buttons.
Page 47
SpO2
TEMPTIME SYS DIA MAP BPM
II:37
___ ___ ___ ___ ___ ___
11~42
___ ___ ___ ___ ___ ___
II:47
___ ___ ___ ___ ___ ___
_- _
Newer
__ _ 11:52
and
Older. These buttons may be used to move
__ _
__ -
__ -
forward and backward through the recorded data. If no
information is available, these buttons will not appear.
oaae.
Print
Selection of this button causes the displayed
information to be printed. If no information is available, this button will not appear.
Main. Selection of this button returns the user to the Main
menu.
Clear
Selection of this button produces an advisory that the trend
will be lost. Choosing Yes will erase the trend memory.
Choosing No will retain the trend memory. This button disappears from the menu while printing and when Trend is
empty.
-
- -
Print All
Selection of this button prints all the historical data available.
When selected, this button temporarily changes to Cancel
until the history has completed printing. Once printing is complete, the Cancel button returns back to the Print All button. This button disappears from the menu when Trend is empty.
Main
Selection of this button returns the user to the Main menu.
52
;;
Page 48
1
Using the Menu System
Print Button
Selection of this button displays the Print menu.
PRINT
Auto/Man
Pressing this button toggles between Automatic and Manual Printing the LCD. The Automatic mode prints the readings after each determination. The Manual mode, which is the factory default mode, requires the user to press the Now button to print the readings.
Now Selection of this button causes the last readings of the available parameters to be printed. If no readings are available, the message “No reading” is printed for that parameter. An error message appears if there is no paper in the printer.
modes. The current mode is displayed on Area 3 of
MENU
His tory
Selection of this button causes the entire contents of the
trend memory to be printed. When selected, this button temporarily changes to Cancel until the history has
completed printing.
Main
Selection of this button returns the user to the Main menu.
More... Menu
This menu is used to set the various operating modes of the
Monitor.
Page 49
SpO, Button (Models 300 and 400)
Selection of this button displays the which
is used to set the
SpOZ
pulse tone volume.
SpOz
mode menu,
Volume
[
Main
Volume
The pulse tone volume can be set in the range of Off to 9.
The value Off should be selected if no pulse tone is desired.
The volume
and is restored to the user’s preference each time the Monitor is switched on.
Main
Selection of this button
Config
Selection of this button
which allows the Power
Button
setting is stored when the Monitor is turned off
returns the user to the Main menu.
displays the
Save
5
1
Config
mode and time to be adjusted.
mode menu,
Rotor
I
Pwr Sav (Sleep Mode)
Selection of this button allows the operator to specify the time, in minutes, that elapses before the Monitor goes into “sleep” mode from
LEDs).
operating from its battery. Sleep mode conserves
while the Monitor is not in use. Once the Monitor
Sleep mode, the user can return it to normal operation by
touching any button or the rotor.
(LEDs
Sleep mode is available only if the Monitor is
blanked and LCD displaying values
t
54
Main
I
I
power
is in
Page 50
C
Using the Menu System
-
POWER SAVE MENU
Monitor enters Sleep mode only if the following are true:
The
.
No alarm is active
.
SpO,
is not actively reporting patient statistics
.
The keys and rotor have not been used for the preset
time The Monitor is running from its battery No determinations are
The Monitor
entire preset
The
Monitor awakens from Sleep mode if any of the
following occur:
The
rotor is turned or pressed
has been running from the battery for the
time
in progress
Any of the keys are pressed An alarm condition is issued The battery supply level becomes discharged to a
critical level
A mains or suitable DC supply is connected An
Auto BP or Temp determination starts
An
SpO, signal is detected
A BP
determination is started through the host
comm
P
L.
I-*,
Time
Selection of this button allows the operator to change the internal time and date of the Monitor.
maintained by an internal battery after power
2Qhour
format. The date is in the British format of
The clock, which is
down, uses
dd/ mmm/yyyy; however, to avoid confusion the month number has been substituted with a three-letter abbreviation. Leap
years are calculated automatically.
55
Page 51
20
:
21
24-Aug-1999
11
.;
,_
1
, Hour,
,
Min , ,
Set
,
Mon ,
,
,
Day
,
,Year
1,
Accept. Selection of this button produces an advisory to the
user that the trend will be lost when the clock settings are
changed. Choosing Yes will cause the Monitor to accept the
new clock settings and erase the trend memory. Choosing No will cause the Monitor to retain the existing clock settings and the trend memory. Either choice returns the user to the Main menu.
Main Selection of this button returns the user to the Main
d
menu.
Rotor
Selection of this button displays a panel for setting the volume of the beep that sounds when the rotor is turned.
The range of adjustment is Off (default) to 9, and the setting
is retained when the Monitor is turned off.
,
ROTOR BEEP
Volume
1
Main
Main
Selection of this button returns the user to the Main menu.
Display Button
Selection of this button displays the Display mode menu. This menu is used to specify whether Area 2 of the LCD
SpO,
display
selected, Area 2 of the LCD will remain blank except for the
pulse amplitude bar (if
error or warning messages that may appear. The Display
mode setting is maintained when the Monitor is switched off and on.
or BP data. If neither
Sp02 data are available) and any
SpO,
3
1
nor 3
NIBP
is
will
Page 52
Using the Menu System
SpO2
Pleth
SpOz
Pleth
When
the plethysmograph waveform and the pulse amplitude bar will be displayed.
3
When this option is checked, the last 3
be displayed. If
this option is checked and
N/BP
Sp0~
data is available, the pulse amplitude
i
SpO;!
4X 4
data are available,
NIBP
readings will
bar will also be displayed.
Main
Selection of this button returns the user to the Main menu.
Service Button
Selection of this button displays a keypad that allows the
clinician to access some parts of the Service mode menu.
To access the Clinician menu, use the rotor to select the
numbers 1, 2, 3, 4
sequentially.
Notes
SpO2
l
is automatically disabled when entering Service
mode.
l Service modes that affect the calibration or alignment
of the instrument are not available to the user. These
modes are described in the Service Manual.
Page 53
Clinician Menu
Press. Selection of this button displays a panel for setting the
default
BP target inflation pressure. Adjusting the default target
pressure will automatically update the current inflation target
pressure and will be used for the next reading.
adjustment
is 100
mmHg
to 180
mmHg,
and the setting is
The range of
retained when the Monitor is turned off.
The initial target pressure can be set between 100 and 180
mmHg
in 5
mmHg
increments. The factory default is 160
mmHg
for adults and 110 for neonates. This is indicated by the “AUTO”
label at the end of the adjustable range. When the target pressure is changed, the next determination will use the new target inflation
value if no systolic is available.
menu
of the Service mode, the target pressure is adjusted
When adjusted under the Clinician
permanently.
*
___*’
.>I
i
_I
.r’
_.A
-i
..,
TARGET PRESSURE
Default
100
i
OK. Selection of this button returns the user to the Clinician
menu.
Temp. Selection of this button displays the temperature
submenu, which allows the user to choose the temperature
label. When C (Celsius) is selected, the
“F
F (Fahrenheit) is selected, the
indicator lights.
58
“C
indicator lights. When
Page 54
Using the Menu System
OK
I
F.
C or
between Celsius and Fahrenheit and produces an advisory that the trend will be lost. Choosing Yes will cause the Monitor to accept the new temperature label and erase the trend memory. Choosing No will cause the Monitor to retain the existing temperature label and the trend memory.
OK. Selection of this button returns the user to the Clinician menu.
Info. Selection of date of the the user to the Clinician menu.
Selection of this button toggles the temperature display
TREND WILL BE LOST
this button causes the most recent calibration
NIBP
system to be displayed. Selection of OK returns
t
Last Calibration
NIBP 14-Jul-1999
OK. Selection of this button returns the user to the Clinician menu.
More.... Selection
allows the user to permanently change default mode settings.
of this button displays the More... menu, which
Page 55
Trend. Selection of this button displays the message:
Automatically clear trend on power-up? Selection of Yes overrides the default setting by clearing all trends on power-up and returns the Monitor to the More... menu. Selection of No retains the default setting by saving all trends after power-off and returns the Monitor to the More... menu. Selection of Cancel returns the user to the More... menu.
Print. Selection of this button displays the message: Restore Print mode on power-up? Selection of Yes restores the Print mode to
the default setting (previous user-selected mode) after power-off and returns the Monitor to the More... menu. Selection of No restores the Print mode to the Manual mode after power-off and returns the Monitor to the More... menu. Selection of Cancel returns the Monitor to the More... menu.
Set BP. Selection of this button displays the message: Restore BP
mode on power-up? Selection of Yes restores the BP mode to
previous user-selected mode after power-off and returns the Monitor to the More... menu. Selection of No restores the BP mode to the default setting of Manual after power-off and returns the Monitor to the More... menu. Selection of Cancel returns the Monitor to the More... menu.
A/arms. Selection of this button displays the message: Enter alarm
configuration mode? Selection of No returns the Monitor to the
More... menu. Selection of Yes brings up the Alarms menu. Selection of Reset changes all alarm limits back to the factory defaults and returns the Monitor to the More... menu. Selection of Save permanently saves the user-selected alarm limits and returns the Monitor to the More... menu. Selection of Cancel returns the Monitor to the More... menu.
SYS
DIA
MAP BPM
60
_.
Page 56
k
Using the Menu System
Main. Selection of this button returns the user to the Main menu.
Silence. Selection of this button will cause all alarms except the FAILSAFE alarm to be muted. A confirmation menu will appear in
Area 2 of the LED. Selection of either Yes or No returns the user to the Clinician
button (26) illuminates and alarms are permanently muted.
silence is not confirmed, the alarm will be audible.
Caution: Alarms will be muted until either the Monitor is switched off and on again or the Alarm Silence pressed.
mode menu. If silence is confirmed, the Alarm Silence
If
button (26) is
Confirm silence
Main Selection of this button returns the user to
-*
the Main menu.
Page 57
Error and Warning Messages
The error panel appears in Area 2 of the LCD and indicates the
error and its code, if it has one. In this example, a limit violation alarm (which has no error code) has occurred. A list of alarm error messages and their codes is in Appendix B.
_
,
HIGH SYSTOLIC
pi-1
j
L
Alarm conditions are addressed in two ways: the Alarms button and OK button.
Alarms Button
Selection of this button takes the user to the Alarms menu, where the alarm limits can be adjusted. This button is available only when a parameter alarm limit has been violated.
OK Button
Selection of this button acknowledges the error. The Monitor clears the identified error and
then returns the user to the Main
menu.
,’
.I
.i
62
i
Page 58
Technical Specifications
Hz
Cuff Pressure Range (Normal operating range)
Appendix A
0 to 290 0 to 140
mmHg mmHg
(adult)
(neonate)
160
f
+
15
15
mmHg
Default Target: Cuff Inflation
Target Cuff Inflation: Adjustment Range
(in 5
mmHg
increments)
110
100 to 250 100 to 140
Blood Pressure Measurement
Range Adult
(mmHg)
Systolic
30-245
MAP
15-215
Neonate 40-140 30-115
Blood Pressure Accuracy
Maximum Determination Time
Meets
AAMI
(mean error standard deviation 18
mmHg)
120 s (adult)
85 s (neonate)
or exceeds ANSI/
standard SP-10
mmHg
mmHg
mmHg
<5
(adult)
(neonate)
(adult)
(neonate)
Diastolic
10
-195
20
-100
mmHg,
Overpressure Cutoff
Pulse Rate Range
Pulse Rate Accuracy
IVAC*
Temoeraturq
Scale
Range
Predictive
*IVAC
is a trademark of
mode
300 to 330
150 to 165
I!I
3.5%
“Fahrenheit (F) “Celsius (C)
Max: 42.2’ C; 108.0” F
Min: 3 1.6” C; 88.9” F
ALARIS Medical Systems
mmHg
mmHg
200
30 to
beats/min (adult)
200
beats/min (neonate)30 to
(adult)
(neonate)
Page 59
Monitor mode
Max: 42.2” C; 108.0”
Min: 26.7” C; 80.0” F
F
Monitor mode accuracy
&O.l”C +
0.2” F (when tested in a
calibrated liquid bath; meets ASTM
El 112, Table 1, in
range specified)
.O”
Predictive mode accuracy
Determination time
IVAC
Use only
probes and probe covers. The size, shape, and thermal
+
3~
less than 60
F
1
0.6” C
seconds
characteristics of the probe covers can affect the performance of the instrument. Inaccurate readings or retention problems may occur unless IVAC
probes and probe covers are used. Refer to Appendix D for
reorder codes.
Functional Oxygen Saturation: Range Accuracy
0 to 100% 0 to 69%: unspecified
1
100%)
-
Adult Accuracv (70% NELLCOR Sensor
OXICLIQ-P pediatric sensor
OXICLIQ-I
infant sensor
OXICLIQ-A adult sensor OXICLIQ-N neonatal/adult sensor OXIBAND pediatric/infant sensor OXIBAND adult/neonatal sensor
DURA-Y ear clip REFLECTANCE
DURASENSOR adult PEDI-CHECK pediatric spot-check clip
OXISENSOR
OXISENSOR
sensor
II D-20 pediatric sensor
II
D-25 adult sensor OXISENSOR II N-25 neonatal/adult sensor OXISENSOR II l-20 infant sensor OXISENSOR II D-25L adult sensor, long cable
Accuracv
2.5
digits
2.5
digits
2.5
digits
2.5
digits
3.0
digits
3.0
digits
3.5 digits
3.5
digits
3.5
digits
3.5
digits
2.0
digits
2.0
digits
2.0
digits
2.0
digits
2.0
digits
Page 60
Appendix A
OXISENSOR *Accuracy: 80% to 100%; 0 to 79%: unspecified.
Neonatal
R-l 5 adult nasal sensor*
100%)
-
(70% Accuracv
3.5 digits
When sensors are used on neonatal subjects as recommended, the specified accuracy range is increased by
+_l
digit to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood (e.g.,
is
+3,
rather than
Note: Refer to
+2).
NEI_I_COR’s
sensor specifications.
Pulse Rate Range
Accuracy
Audible Indicator
N-25 accuracy on neonates
30 to 250 beats/min
beats/min
f3
Pitch changes with saturation; volume selectable from 0 (off) to 9
Waveforms
Pulse plethysmograph waveform on LCD gain compensated
Sensor Connect/ Disconnect From Patient
Pulse Detection
Loss of Pulse
Sensor Light Source Wavelength
Power Dissipation
Monitor will detect
attachment or
disconnection of sensor from patient within
15 s
Monitor will detect pulse
or enter no signal state
within 15 s of being
attached to patient
Monitor will detect loss of
pulse from patient and enter
no signal state within 10 s
Infrared: 920 nm (nominal)
Red: 660 nm (nominal)
mW
Infrared: 22.5
Red: 30
mW
(max)
(max)
Page 61
Dimensions
Weight, Including Battery Mountings
Height: 9.8 in (25.0 cm)
Width: 9.8 in (24.8 cm)
Depth: 6.9 in
7.8
lb (3.5 kg)
(17.5 cm)
Self-supporting on rubber
feet or pole mountable
_I*
I
>.
,
Portability
Classification Information
.
Power
Rewemen&
Carried by recessed handle or pole mounted
Mode of operation: continuous
Degree of protection against harmful ingress of water: Drip-proof
AC input voltage:
50
/
60 Hz (nominal)
90
-
253 VAC, 47
SOVA.
Protection against electrical
shock: Class 1
DC input voltage: 24
(nominal), 12-30 VDC,
supplied from a source conforming to IEC 601-l. AC input is protected by two internal fuses, replaceable by qualified service personnel only. DC
IPXl
loo-240
-
63 Hz (range),
VAC,
VDC
36VA,
input line is protected by an internal auto-resetting
Battery: 12 volt, 2.3 amp- hours
protected by internal auto-resetting
fuse.
fuse.
Minimum operation time:
2
hrs (5 min cycle with adult cuff at
25
“C
with power save mode
,
_> _,
66
Page 62
nvlronmental
Operating Temperature
Appendix A
enabled) from full charge. Time
for full recharge:
from full discharge
Monitor is switched off and 8 hrs when the Monitor is switched on.
“C
+ 5 (+ 41
to + 40
“F to + 104
1 hr 50 min
when the
“C
“F)
hPa
Operating Atmospheric Pressure 700
-
Storage Temperature
Storage/Transportation
Atmospheric Pressure 500
Humidity Range 0% to 95% noncondensing
Radio Frequency Complies with IEC
20
(- 4
Publication 601-l-2 (April
1993) Medical Electrical
Equipment, Electromagnetic Compatibility Requirements and Tests and (Group 1, Class A) for radiated and conducted emissions.
to 1060
“C to + 50
-I-
122 “F to
hPa
to 1060
hPa
“C
“F)
hPa
CISPR
11
IPXI
DINAMAP@
The
against vertically falling drops of water and conforms with the IEC 529 standard at level of
of vertically falling drops of water making
contact with the Monitor.
IPXl.
PRO Monitor is protected
No harmful effects will come
67
Page 63
Appendix B
Alarm Codes
All alarm indications are accompanied by an audible signal
unless Alarm Silence is selected.
A
microprocessor system failure will generate a high-pitched
audible alarm regardless of the setting of the Alarm Silence
switch.
There are three categories of alarms: patient alarms, system
alarms, and failsafe alarm.
Patient Alarms
Patient alarms include those alarms issued when the patient’s systolic pressure, diastolic pressure, pulse rate, or oxygen saturation is outside the set limits. Whenever one
of these conditions
(SYSTOLIC, MAP, DIASTOLIC, PULSE, or
the most
recent reading and an audible alarm will be issued.
occurs, the associated display
SpO,)
will flash
Pressing the Alarm Silence switch (causing the integral LED to
be lit) silences the audible alarm for 2 minutes, but the alarm display reading and SILENCE LED indicator will continue to flash at the same rate.
System
Alarms
System alarms alert the operator to certain abnormal conditions or internal system failures. Pressing
cancels the alarm information box which is displayed on the LCD. Codes for different procedural and system alarms are on the next page.
the rotor
Failsafe Alarm
The failsafe alarm, which is the most powerful alarm of the
PRO Monitor, indicates a serious failure of the Monitor.
This alarm
and indicates system failure. When the failsafe alarm occurs, the Monitor disables all features to ensure patient safety.
occurs immediately upon any failure of a self-test
7
-.
7.
69
Page 64
Hierarchy of Alarms
Alarms in the
levels. They are:
DINAMAP@ PRO Monitor are in three priority
Alarm
Failsafe Patient and system Low battery
The Priority 1 alarm (i.e., Failsafe) will override any other
alarm. Priority 2 alarms will override only the low battery alarm. The low battery alarm will not override any other alarm.
Priority Level
1 2 (High priority alarm) 3
-70
Page 65
N33
N44
N55
N99
Alarm
Code Display
zknge
NO0
NO0
-
PRESSURE
OVER
adjustable
%%!?%&e
. .
fl~~:~tes
change TIMEOUT:
No
N33
-
change TIMEOUT: TOTAL
No
N44
-
INFLT
adjustable
alarm. Volume Clear
silence
adjustable
High priority
2 minutes
silence
alarm. Volume
2 minutes
change TIMEOUT: PRESS
No
N55
-
adjustable
High priority
alarm. Volume
2 minutes
silence
change
NIBP FAILED
High priority
adjustable
alarm. Volume
silence
No
N99
-
High priority
and Volume
2 minutes
Switch
LED
LCD
Display
Procedural and Error Alarm Codes
Audible
Tone
Alarm Silence Clear via
Effect of
I
Clear
Overpressure detected
or air leak detected
Clear
Determination time
Inflation time
minutes. Motion artifact
Clear
One cuff pressure for
minute. Motion artifact
Clear
determination due to
insufficient signal
SelectKno b
Unable to make an
Effect of
Probable Cause
Page 66
Code
No
EOO
E33
Code
No
Code
No
PO0
P55
4larm
Code
Blank
HIGH TEMP
2dj$ahIe
High Priority
alarm. Volume
silence
2
minutes
change
No
TEMP: FAIL
EOO
-
adjustable
High Priority
alarm. Volume
silence
2 minutes
change
No
TEMP: FAIL
E33
-
alarm. Volume
High priority
adjustable
silence
2 minutes
Values
zeroed
SpO, CABLE?
High priority
alarm. Volume
adjustable
silence
2 minutes
change
No
PLACEMENT?
SPO,
adjustable
alarm. Volume
2
silence
minutes
adjustable
High priority
No
change
NO
PO0
SpO,
-
SENSOR
High priority
alarm. Volume
;ilence
2 minutes
Ehange
;pO, NO SIGNAL
adjustable
;ilence
NO
‘55
-
High priority
alarm. Volume
2
minutes
Display
LED
LCD Description
and Volume
4larm Silence
Switch
.
Procedural and Error Alarm Codes (cont.)
Audible
Tone
Effect of
Clear
exceeds upper range
Predictive temperature
Clear
determination
attempting axillary temp
Predictive temperature
Clear
Temperature probe not
connected or inoperable
Clear
SpO, sensor or cable
possibly defective. Cable
not connected properly
Clear
Sensor failure
SpO, signal weak or noisy.
Clear
SpO, sensor not connected.
Sensor failure
No sensor code detected.
Zlear
Check or reposition sensor
No or very low
SelectKnob
Clear via
Effect of
Probable Cause
Page 67
E, 1,
S
3ther:
N, P,
Blank
Code Posted
No
Code Change NO PAPER
Values
No No
,“,z, Blank
Code Change
No No
Alarm
Code Display
LED
description
Error code,
volume
maximum
Steady tone,
No effect
No effect Internal system fault
ERROR
adjustable
alarm. Volume
silence
Clear
NIBP RANGE
adjustable
High Priority
2 minutes
silence
PRINTER
-
alarm. Volume
High Priority
2 minutes
Clear
SYSTEM
DISABLED
volume
maximum
No effect
No effect
LOW BATTERY,
Flashing
LOW BATTERY
-
Steady tone,
battery icon
volume
adjustable
10 seconds,
2 minutes
silence
No effect measurements available.
LCD Description
3 beeps every
and Volume
Alarm Silence
Switch
SelectKno b
Clear via
Procedural and Error Alarm Codes (cont.)
Audible Tone
Effect of
Effect of
value outside specified
accuracy range
NIBP
door open
Paper ran out or printer
algorithm returned
From onset of alarm. 5
Replace or recharge battery.
NIBP
as battery discharges
Beep rate increases linearly
Replace or recharge battery.
measurement disabled
Probable Cause
Page 68
Appendix
Principles of Noninvasive Blood Pressure Determination
The oscillometric method of determining BP is accomplished by a sensitive transducer which measures cuff pressure and minute pressure oscillations within the cuff.
The first determination sequence initially pumps up to a cuff
pressure of about
1 10
mmHg
pressure preset. After inflating the cuff, the Monitor begins to deflate it and measures systolic pressure, mean pressure, and diastolic pressure. When the diastolic pressure has been determined, the Monitor finishes deflating the cuff and updates the systolic, diastolic, and MAP displays on the front panel.
The Monitor deflates the cuff one step each time it detects
two pulsations of relatively equal amplitude. The time between deflation steps depends on the frequency of these matched pulses (pulse rate of the patient). However, if the Monitor is unable to find any pulse within several seconds, it will deflate to the
matched pulses at each step provides artifact rejection due to patient movement and greatly enhances the accuracy of the Monitor. The figure
sequence.
for neonates depending on the initial target
mmHg
160
next step. The process of finding two
shows the BP determination
for adult/pediatric patients, or
C
OSCILLATION
t
1
TIME
BP Determination Sequence
75
-1
Page 69
nq
i3l#
qeM
uo!yel4u!
‘al3h3
uoya~~a)u!
l!eM
-au_q :s]Jed
8ugeJadO
‘3pOl.U
S!
paJXj4P
pue
moj
40
3!seg
Jo)eJado
(enuew)
i3pOUJ
0)
uoyenlem
%uJ!~
pasoduro3
‘(ap0~U
aql
s~oys
JO
ayl
(ap0~1
Sa!JPA
LUOJ4
‘auq
al3A3
s!
aJn%j
O$r’I\d)
uo!3eljap
$$eJadO
~LIJ!]
al3b
‘Xll!~Y3!YM
‘auy
ayl
‘elep
Sa)el4ap
a41
le303
uog~ajap
ayssamns
---.--q
‘amswd
paJO]S
Uaq]
pau!lu~a]ap
JO Hn3
aslnd
uaamjaq
ay$
JO)!UOW
payxeur
jjm
*sAelds!p
SaZ/i(eUe
ayl
s!
pue
sa.ioy~
laued
‘(aJnssaJd
‘8#ULll
aJnSSaJd
uo!leljap
rossa3oJdo+u
mloJse!p
‘apnj!ldLue
aye
1~0~4 pa]Xlap
MOlaq
L
paddaIs
I!gun
ayl pue awg
aye
salepdn
OJaZ
a.mssaJdSIIej
sanuguo:,
ayl
payweLuaslnd
01)
xaslnd
y3ea
pue
#-I3
dais
l\d
Page 70
Appendix
absence of a systolic value, stop deflation, reinflate to a higher (than initial) inflation pressure (290 maximum), and resume normal deflation sequence. This
additional inflation will
If a previous valid systolic pressure is displayed, and the new systolic pressure oscillations are compared with the previous valid determination and the Monitor “thinks” that
the systolic was not obtained, the Monitor will inflate the cuff to a pressure of an additional 50 immediately preceding inflation. This additional inflation will
occur only once per determination.
occur only once per determination.
mmHg
mmHg
above the
C
Do not use the
of the Monitor. Because of differences in technique and
technology, values may differ. The
of the PRO Monitor compares BP values to an invasive arterial BP measurement technology.
method uses audible sounds heard through a stethoscope and determines BP by the corresponding height of a
column of mercury.
Invasive pressure monitoring directly measures the pressure
exerted on a transducer and displays this pressure as a
value. Noninvasive blood pressure monitoring is dependent
on the flow of blood through the peripheral circulation.
auscultatory method to verify the accuracy
DINAMAP@
The auscultatory
Technology
77
Page 71
-1
Appendix D
Compatibility Table and Reorder Codes
Description of Compatible Parts
SOFT-CUP”, Infant SOFT-CUFT”, SOFT-CUFT”,
SOFT-CUFT”, SOFT-CUP”, Large Adult
SOFT-CUP”,
SOFT-CUP”, Neonatal Type
SOFT-CU SOFT-CUp”,
SOFT-CUP”, Neonatal Type
SOFT-CUP”, Neonatal Type 5
DURA-CUF@
DURA-CUF@
DURA-CUF@
DURA-CUF@
DURA-CUF@
DURA-CUF@
DURA-CUF@
DURA-CUF@
CLASSIC-CUFC”,
CLASSIC-CIJp”, Child 2613
CLASSIC-CUP”, Small Adult 2608
CLASSIC-CIJp”, Adult 2603
CLASSIC-CU
CLASSIC-CUFT”, Thigh
CLASSIC-CUp”, Neonatal Type 2 2633
CLASSIC-CUFT”,
CLASSIC-CUp”, Neonatal Type 4 2623
CLASSIC-CIJFC”,
12 Foot (approx. 3.7 m) Long Adult
24 Foot (approx. 7.3 m) Long Adult
12 Foot (approx. 3.7 m) Long Neonatal Hose 107368 12 Foot (approx. 3.7 m) Long A/P Hose Quick IVAC** Oral Temperature Probe IVAC** Rectal Temperature Probe
IVAC** Temperature Probe Covers DINAMAP@
DINAMAP@
Child Small Adult Adult
Thigh
1
FT”,
Neonatal Type 2
Neonatal Type 3
4
Cuff, Infant Cuff, Child Cuff, Small Adult Cuff, Adult Cuff, Large Adult Cuff, Thigh
Cuff, Assortment Cuff Pack Cuff, Child Pack
Infant 2618
M,
Large Adult
f
1
Neonatal Type 3 2628
Neonatal Type 5 2619
/
Pediatric Hose 107365
/
Pediatric Hose 107366
Discon.
PRO Monitor Operation Manual PRO Monitor Service Manual 777105’
Code
2500
2501
2502
2503 2504 2505
2521
2422 2523 2524 2525 2783 2781 2779
2774 2791
2796 2699 2697
2643 2648 2638CLASSIC-CUp”, Neonatal Type
88847 088012 088013
088015
776995’
*PRO Monitor unique parts **IVAC
is a trademark of
ALAR6
Medcial
Systems
Page 72
12 Volt Lead Acid Battery
Accessory Pole/Basket
Accessory Base
Power Converter Printer Paper (box of 10) Power Cable
SpOz
NELLCOR
Extension Cable NELLCOR Finger Sensor BP Cal Kit
*PRO Monitor unique parts NELLCOR is a trademark of Mallickrodt, Inc.
633132 3210 3211 621262’ 089 1 00* 316579 SCPl o* DSlOOA 320246
NEONATAL
CUFF TYPE
#l
#2
#3
#4
#5
ADULT/PEDIATRIC
CUFF TYPE
Infant
Child
Small Adult
Adult
Large Adult
Thigh
LIMB
CIRCUMFERENCE
-
6 cm
3 cm
-
8 cm
4 cm
6cm-11
cm 252312628
7cm-13cm
8cm-15cm
LIMB
CIRCUMFERENCE
8cm-13cm
l2cm-19cm
17cm-25cm
23 cm-33cm
31 cm-40cm
38cm-50cm
REFERENCE
USE WITH HOSE
NUMBER
252112638
2422/2633
107368 Teal Green,
Neonatal, 12
2524/2623
252512619
REFERENCE NUMBER
2703/2500/2618
2781/2501/2613
2779/2502/2608/2607
2774/2503/2603/2602
2791/2504/2643/2642
2796/2505/2648
NO.
ft (366
cm)
USE WITH HOSE
NO.
107365 Adult 12 ft
(366 cm) Air Hose
Gray (made with
Clippard screw
connectors at cuff
end)
or 107366 Adult 24 ft (732 cm) Air Hose
Gray (made with
Clippard screw
connectors at cuff
end)
or
88847 Long
12 ft (366 cm) Air
Hose (quick disconnect)
A/P
Page 73
Appendix F
Maintenance
Cleaning the Monitor
The Monitor and accessories are to be kept clean and
according to the instructions provided here and
Service Manual.
The exterior of the Monitor may be wiped clean with a soft
cloth slightly dampened with mild detergents. The Monitor and accessories should be inspected once yearly for wear and damage.
l Do not immerse unit.
.
Do not clean with isopropyl alcohol or other solvents.
l Do not immerse hoses.
Cuff Cleaning and Disinfection
General
The cuff must be thoroughly cleaned with the specified detergent before reuse. The additional use of household
bleach as described below provides at least level disinfection.
in the
intermediate-
used
.
Apply cuff hose plugs before cleaning.
l
The following cleansing procedure was repeated 20
times on
SOFT-CUF@
DURA-CUF@Blood
Blood Pressure Cuffs without affecting the
Pressure Cuffs and once on
performance of the cuff.
While this procedure is adequate for cleaning/
disinfection, it may not remove all stains.
.
Do
not immerse hoses.
.
nof
Do
immerse cuffs without prior application of cuff
hose caps.
Materials
l Enzymatic detergent such as ENZOL* enzymatic
detergent (US)
l Distilled water
or Cidezyme* enzymatic detergent (UK)
l 10% solution of household bleach (5.25% sodium
,-
*Trademark
K
hypochlorite) in distilled water
83
Page 74
l Soft cloths and soft-bristled brushes
.,/:
-
Spray bottles
Procedure
1. Prepare the enzymatic detergent according to the manufacturer’s instructions and the 10% bleach solution,
in separate spray bottles.
2. Spray the detergent liberally on device. If the material is dried on, allow the cuff to sit for 1 minute. For soil on
the soft part of the closure or the cuff itself, wipe the material off with a soft cloth. For persistent contamination on the soft part of the closure, use a soft- bristled brush to loosen particles. Rinse with copious amounts of distilled water. Repeat until no visible contamination remains. For soil on the hook part of the closure, use a soft-bristled brush to remove the material, and rinse with copious amounts of distilled water. Repeat until no visible contamination remains.
3. Spray the 10% bleach solution on the affected area until the area is saturated. Allow the cuff to sit for 5 minutes.
4. Wipe away any excess solution and rinse the cuff again with distilled water. Allow 2 hours for drying.
.I
.:
I
.,.
./,
II
,I
.
,*
i
_.
The user has the responsibility to validate any deviations
from the recommended method of cleaning and disinfection.
For additional information
on infection control procedures,
contact Critikon Technical Support.
Temperature Devices
Do not immerse predictive temperature probes. The probe may be cleaned with an alcohol solution. Use a cloth or sponge-just damp, not wet-and avoid getting any liquid into the interior of the probe.
SpO, Sensors
Adhesive sensors are sterile and for single use only.
Reusable
70% alcohol solution. Do not immerse the sensor
sensors should be cleaned before reuse with a
completely in water, solvents, or cleaning solutions
(because the connector is not waterproof). Do not sterilize the sensor by irradiation, steam, or ethylene oxide. If
1-i
84
Page 75
Appendix F
disposable sensors or their packaging are damaged, they
must be disposed of as advised
Storage and Battery Care
If it becomes necessary to store the Monitor for an
extended period of time, first fully charge then remove the
battery. original packaging materials.
Batteries should always be fully charged before being placed in
charged battery can retain about 80% of its charge. A fully charged battery
power to operate a Monitor for approximately 2 hours, including temperature and BP
S-minute intervals.
It
is best to keep the battery charged as fully as practical and condition. When the battery will no longer hold a charge, remove and replace it with one of the same part number.
Failure to replace the battery with the same Critikon part number may result in shorter battery life.
Then store the Monitor and the battery in the
storage. Even after 6 months of storage, a fully
in good condition will provide sufficient
never store the Monitor with the battery in a discharged
in Appendix F.
measurements made at
To charge the battery, insert the plug from either the AC
mains power
cord or the AC-DC power converter into an
appropriate AC outlet. The battery will charge regardless of the
position of any switches.
Battery charging will take place as
remains connected to an external AC power source. A
battery that is fully discharged can be fully recharged in
hour 50 minutes when the Monitor is switched
long as the Monitor
off or 8
hours if the Monitor is switched on.
Cautions
.
To ensure that the battery will be ready for portable
operation, keep the Monitor connected to a mains supply whenever possible.
.
Repeated failure to fully charge the battery will result in a significant reduction in battery life.
1
Page 76
l The expected lifetime of the battery largely depends on
the way in which the Monitor is used. If the battery is
allowed to completely discharge before being fully recharged, the battery should survive around 200 recharge cycles. If the battery is used in such a way that it never becomes more than one third discharged and is
fully recharged whenever possible, it can survive up to
1200 cycles. This means that by thoughtful usage, the
lifetime
Replacement batteries may be obtained from Critikon. Note: The replacement part number of the battery is 63313. Do not use other types.
of the battery can be extended up to six times.
Fuses
The Monitor contains five fuses. Two AC line input fuses are
mounted internally and are replaceable only by qualified service personnel. The remaining three fuses are auto- resetable and mounted within the Monitor. These fuses protect the low voltage DC input, the battery, and the output
on the host port connector.
+5
V
Calibration
Calibration of the BP parameter should be checked at least once a year or when there is doubt about the validity of the readings.
Leak Testing
A leak test of the BP parameter should be performed at least
once a year or when there is doubt about the validity of the
pressure readings.
Caution: Refer calibration and leak testing to qualified service personnel. Full calibration details are available in the
DINAMAP Critikon.
PRO Monitor Service Manual, available from
Disposal of Product Waste
As you use the PRO Monitor, you will accumulate solid wastes that require proper disposal or recycling. These include
batteries, patient applied parts, and packaging material.
.
._
.
-86 ._
Page 77
Appendix F
Batteries Caution: Do not incinerate batteries.
The sealed, rechargeable backup battery contains lead and can be recycled.
the Nickel Metal Hydride form. Discharge this battery prior
to disposal. Place the battery
electrically isolates
the battery in a trash compactor. Do not
battery or expose it to fire or high temperatures. Dispose in accordance with regional body controlled guideline.
Patient Applied Parts
Certain patient applied parts, such as those with adhesive (disposable should be disposed of properly as medical waste in accordance with regional body controlled guideline.
Other patient applied parts, such as blood pressure cuffs, should be cleaned according to instructions. Inspect reusable applied parts for wear, replace as necessary, and dispose of used product as medical waste in accordance with regional body controlled guideline.
SpO, sensors), are intended for single use and
The rechargeable memory battery is of
in packaging which
its contents. Do not puncture or place
incinerate the
Packaging Material
Retain original packaging materials for future use in storing
or shipping the Monitor and accessories. This
recommendation includes corrugated shippers and inserts.
Whenever possible recycle the packaging of accessories
and patient applied parts.
87
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