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GE Dinamap PRO Series User manual

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1
DINAMAP®PRO
Series 100-400V2
Monitor
Operation Manual
2
DINAMAP®PRO 400V2 Monitor
3
DINAMAP®PRO Monitor
Operation Manual
This manual is for DINAMAP®PRO Monitor Models 100V2,
200V2, 300V2, and 400V2, all with printers.
• PRO 100V2: BP and Pulse
• PRO 200V2: BP, Pulse, and Temp
• PRO 300V2: BP, Pulse, and SpO2
• PRO 400V2: BP, Pulse, Temp, and SpO2
The model of the Monitor determines which menu option
buttons appear on the LCD. Please refer to applicable
sections.
The Model Number 100-400V2 is generic in nature and
reflects the range of product codes available. Your product
may be labeled with a specific product code such as
DINAMAP® PRO Model 410. "V2" refers to the second
version of the product's design.
Reissues and Updates
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:
GE Medical Systems Information Technologies
4502 Woodland Corporate Boulevard
Tampa, FL 33614
1-877-274-8456
Part No. 2009802-001B
The content of this document including all figures and
drawings is proprietary information of GE Medical Systems
Information Technologies, provided solely for purposes of
operation, maintenance or repair, and dissemination for
4
other purposes or copying thereof is prohibited without prior
written consent by GE Medical Systems Information
Technologies, Tampa, Florida.
Illustrations may show design models; production units may
incorporate changes.
Hierarchy of Warnings and Cautions
A general warning is a statement that alerts the user to the
possibility of injury, death, or other serious adverse reactions
associated with the misuse of the device. A warning relates
to steps in a procedure.
A general caution is a statement that alerts the user to the
possibility of a problem with the device associated with its
use or misuse. Such problems include device malfunction,
device failure, damage to the device or damage to other
property. A caution relates to steps in a procedure.
© GE Medical Systems Information Technologies, 2002. All
rights reserved. Tampa, FL 33614
Printed in the U.S.A.
United States
GE Medical Systems Information Technologies
4502 Woodland Corporate Boulevard
Tampa, FL 33614
European Representative
GE Medical Systems
Information Technologies GmbH
Postfach 60 02 65
D-79032 Freiburg, Germany
Tel. +49 761 45 43 - 0
Fax +49 761 45 43 - 233
5
Introduction ............................................................................ 7
About the DINAMAP®PRO Monitor ....................................................................7
Product Compliance ...............................................................................................10
Symbols ......................................................................................................................11
Getting Started......................................................................13
Unpacking the Monitor and Accessories ...........................................................13
Power Sources ..........................................................................................................13
Powering the Monitor .............................................................................................13
Rear Panel Connections ..........................................................................................16
Front Panel Controls and Indicators .....................................................................17
Switching the Monitor On and Off.......................................................................19
Liquid Crystal Display (LCD)...................................................................................19
Using the Printer .......................................................................................................20
Installing the Paper ...................................................................................................20
Printer Alarms ............................................................................................................21
Storage ........................................................................................................................22
Using the Monitor ................................................................23
Noninvasive Blood Pressure Determination .......................................................23
Procedures..................................................................................................................27
Manual Mode ............................................................................................................29
Auto Mode.................................................................................................................29
Stat Mode ...................................................................................................................30
TURBO*TEMP............................................................................................................31
Masimo SET®SpO2..................................................................................................37
NELLCOR®OxiMAXTM SpO2.................................................................................46
Using the Menu System .......................................................55
Introduction................................................................................................................55
Liquid Crystal Display...............................................................................................55
Rotor ............................................................................................................................58
Menu Tree ..................................................................................................................58
Main Menu.................................................................................................................58
Vitals Button (UK: All Obs) .....................................................................................59
More... Button............................................................................................................60
Set BP Button (UK: BP Mode)................................................................................60
Alarms Button ............................................................................................................62
Trend Button ..............................................................................................................63
Print Button ................................................................................................................65
More... Menu .............................................................................................................66
SpO2Button .............................................................................................................66
Config Button.............................................................................................................67
Pwr Sav (Sleep Mode) .............................................................................................68
Time .............................................................................................................................69
Rotor ............................................................................................................................69
Temp............................................................................................................................70
Display Button ...........................................................................................................70
Service Button............................................................................................................71
Clinician Menu ..........................................................................................................72
Error and Warning Messages .................................................................................75
Alarms Button ............................................................................................................75
OK Button...................................................................................................................76
Contents
6
Appendix A............................................................................77
Technical Specifications...........................................................................................77
BP .................................................................................................................................77
Temperature...............................................................................................................78
SpO2............................................................................................................................78
Mechanical.................................................................................................................82
Power Requirements................................................................................................82
Environmental ............................................................................................................83
Appendix B ............................................................................85
Patient Alarms............................................................................................................85
System Alarms ...........................................................................................................85
Failsafe Alarm.............................................................................................................85
Hierarchy of Alarms..................................................................................................86
Appendix C............................................................................91
Principles of Noninvasive Blood Pressure Determination................................91
Appendix D ...........................................................................95
Reorder Codes...........................................................................................................95
Appendix E ............................................................................97
Warranty, Service, and Spare Parts.......................................................................97
Repairs.........................................................................................................................98
Packing Instructions..................................................................................................98
Service Manuals ........................................................................................................98
Appendix F ............................................................................99
Maintenance ..............................................................................................................99
Cleaning the Monitor...............................................................................................99
Cuff Cleaning and Disinfection..............................................................................99
Temperature Devices............................................................................................ 100
SpO2Sensors.......................................................................................................... 100
Storage and Battery Care ..................................................................................... 101
Fuses ......................................................................................................................... 102
Calibration ............................................................................................................... 102
Leak Testing............................................................................................................. 102
Disposal of Product Waste .................................................................................. 103
Appendix G .........................................................................105
Host Port Connector (rear panel)....................................................................... 105
7
About the DINAMAP®PRO Monitor
DINAMAP®PRO Monitors provide noninvasive
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, GI/endoscopy, and medical/surgical
units.
The PRO Monitor comes in four different models: PRO
100V2, 200V2, 300V2, and 400V2, all with printers.
• PRO 100V2: BP and Pulse
• PRO 200V2: BP, Pulse, and Temp
• PRO 300V2: BP, Pulse, and SpO2
• PRO 400V2: BP, Pulse, Temp, and SpO2
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.
Indications
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
• Do not use the PRO Monitor in the presence of
magnetic resonance imaging (MRI) devices. There have
Introduction
8
been reports of sensors causing patient burns when
operating in an MRI environment.
• Do not use the Monitor in the presence of flammable
anesthetics.
• 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.
• To avoid personal injury, do not perform any servicing
unless qualified to do so.
• 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 power adapters and
converters approved by GE Medical Systems
Information Technologies.
• The Monitor does not include any user-replaceable
fuses. Refer servicing to qualified service personnel.
• To reduce the risk of electric shock, do not remove the
cover or the back. Refer servicing to a qualified service
person.
• 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
• Do not use replacement batteries other than the type
supplied with the Monitor. Replacement batteries are
available from GE Medical Systems Information
Technologies. See Appendix D.
• The PRO Monitor is designed to conform to
Electromagnetic Compatibility (EMC) standard IEC
601-1-2, 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
9
presence of equipment which does not conform to
these specifications.
• Place the PRO Monitor on a rigid, secure surface.
Monitor must only be used with mounting hardware,
poles, and stands recommended by GE Medical
Systems Information Technologies. 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 applied parts and
accessories approved by GE Medical Systems
Information Technologies, is protected against
defibrillator damage.
Notes
• Waveforms may be distorted and readings inaccurate
when electrosurgical cautery equipment is used while
monitoring with the PRO Monitor.
• The electromagnetic compatibility profile of the PRO
Monitor may change if accessories other than those
specified for use with the PRO Monitor are used.
• 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.
10
Product Compliance
The DINAMAP®PRO Monitor is classified in the following
categories for compliance with IEC 601-1:
• Class l, internally powered
•Transportable
• For continuous operation
• Not suitable for use in the presence of flammable
anesthetics
• Not for use in the presence of an oxygen-enriched
atmosphere (oxygen tent)
• Type BF applied parts
• IPX1, degree of protection against ingress of water
• Sterilization/Disinfection, see Appendix F
DINAMAP®PRO MONITOR
CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE
AND MECHANICAL AND OTHER SPECIFIED HAZARDS
ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO.
601.1. ALSO EVALUATED TO IEC-601-2-30.
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.