Due to continuing product innovation, specifications in this manual are subject to change without notice. The information
in this manual supports software versions 5.4 or later.
Listed below are GE Medical Systems Information Technologies trademarks used in this document. All other trademarks
contained herein are the property of their respective owners.
CD TELEMETRY, CRG PLUS, DASH, DINAMAP, EAGLE, MARS, MUSE, RESPONDER, SAM, SOLAR, TRAMNET, TRAMSCOPE, TRAM-RAC, TRIM KNOB, UNITY and UNITY NETWORK are trademarks of GE Medical
Systems Information Technologies registered in the United States Patent and Trademark Office.
12SL, CENTRALSCOPE, CIC PRO, DASH POR T, EK-PRO, IMP ACT, INTELLIRATE, MENTOR, PRISM, PRN 50-M
and SUPERSTAT are trademarks of GE Medical Systems Information Technologies.
The Dash® 3000/4000/5000 patient monitor bears CE mark CE-0459 indicating its
conformity with the provisions of the Council Directive 93/42/EEC concerning
medical devices and fulfills the essential requirements of Annex I of this directive.
The product is in radio-interference protection class A in accordance with
EN 55011.
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility - Medical Electrical Equipment”.
The system meets the requirements of EN 60601-1-2 (2001) Medical Electrical
Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard:
Electromagnetic compatibility — Requirements and tests.
Exceptions
CE Marking Information
Users should be aware of known RF sources, such as radio or TV stations and handheld or mobile two-way radios, and consider them when installing a medi cal device
or system.
Be aware that adding accessories or components, or modifying the medical device or
system may degrade the EMI performance. Consult with qualified personnel
regarding changes to the system configuration.
Radio and Telecommunication Terminal Equipment Directive
The monitor contains a transmitter. The transmitter bears a CE mark indicating
conformity with the essential requirements specified in Article 3 of the Council
Directive 1999/5/EC of 9 March 1999 concerning Radio Equipment and
T elecommunications Terminal Equipment (R&TTE).
The essential requirements are as follows:
Article 3.1 (a) Health Safety; the product complies with the particular medical
device safety standards specified in the Medical Device Directive 93/42/EEC: EN
60601-1/1990 + A1: 1993 + A2: 1995: Medical electrical equipment. General
requirements for safety .
Article 3.1 (b) EMC; the product complies with:
2000966-338ADash® 3000/4000/5000CE-1
CE Marking Information
General Information
EN 60601-1-2 (2001) Medical electrical equipment: Part 1: General
requirements for safety - 2. Collateral standard: Electromagnetic compatibility requirements and test.
ETS 300 826 (1997): “Electromagnetic compatibility and Radio spectrum
Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for 2.4 GHz
wideband transmission systems and HIgh PErformance Radio Local Area
Network (HIPERLAN) equipment”.
Article 3.2 Protection of the Radio Spectrum: the product complies with: ETSI EN
300 328 (2003): “Radio Equipment and Systems (RES); Wideband transmission
systems; Tec hnical characteristics and test conditions for data transmission
equipment operating in the 2.4 GHz ISM band and using spread spectrum
modulation techniques.
This manual is an integral part of the product and describes its intended use. It
should always be kept close to the equipment. Observance of the manual is a
prerequisite for proper product performance and correct operation and ensures
patient and operator safety.
The symbol means ATTENTION: Consult accompanying documents.
Information which refers only to certain versions of the product is accompanied
by the model number(s) of the product(s) concerned. The model number is
given on the nameplate of the product.
The warranty does not cover damages resulting from the use of accessories and
consumables from other manufacturers.
GE is responsible for the effects on safety, reliability, and performance of the
product, only if:
assembly operations, extensions, readjustments, modifications, or repairs
are carried out by persons authorized by GE;
the electrical installation of the relevant room complies with the
requirements of the appropriate regulations; and,
the device is used in accordance with the instructions for use.
All publications conform with the product specifications and applicable EN
publications on safety and essential performance of electromedical equipment
as well as with applicable UL and CSA requirements and AHA
recommendations valid at the time of printing.
The quality management system complies with the international standards ISO
9001 and ISO 13485, and the Council Directive on Medical Devices 93/42/
EEC.
CE-2Dash® 3000/4000/50002000966-338A
1Introduction
2000966-338ADash® 3000/4000/50001-1
Introduction
Equipment Information
Intended Use
The intended use of this device is to monitor physiologic parameter data on adult,
pediatric and neonatal patients within a hospital or facility providing patient care.
Physiologic data includes the parameters covered in this manual. The monitoring
system is also intended to provide physiologic data over the optional network to
clinical information systems. This information can be viewed, trended, stored and
printed.
Safety Statements
The safety statements presented in this chapter refer to the equipment in general and,
in most cases, apply to all aspects of the monitor. There are additional safety
statements in the parameter chapters which are specific to that monitore d parameter.
The order in which safety statements are presented in no way implies order of
importance.
Dangers
Warnings
Danger statements identify an imminent hazard which, if not avoided, will result in
death or serious injury. No danger statements apply to this monitoring system.
Warning statements identify a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
The following warning statements apply to this monitoring system:
WARNING
ACCIDENTAL SPILLS — To avoid electric shock or device
malfunction, liquids must not be allowed to enter the device. If
liquids have entered a device, take it out of service and have it
checked by a service technician before it is used again.
1-2Dash® 3000/4000/50002000966-338A
Introduction
WARNING
ACCURACY — If the accuracy of any value viewed on the
monitor, central station, or printed on a graph strip is questionable,
determine the patient's vital signs by alternative means. V erify that
all equipment is working correctly.
WARNING
ALARMS — Do not rely exclusively on the audible alarm
system for patient monitoring. Adjustment of alarm volume to a
low level or off during patient monitoring may result in a hazard to
the patient. Remember that the most reliable method of patient
monitoring combines close personal surveillance with correct
operation of monitoring equipment.
After connecting the monitor to the central station and/or nurse-call
system, verify the function of the alarm system.
The functions of the alarm system for monitoring of the patient
must be verified at regular intervals.
WARNING
BEFORE USE — Before putting the system into operation
visually inspect all connecting cables for signs of damage.
Damaged cables and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in
correct working order and operating condition.
Periodically, and whenever the integrity of the product is in doubt,
test all functions.
WARNING
CABLES — Route all cables away from patient's throat to avoid
possible strangulation.
2000966-338ADash® 3000/4000/50001-3
Introduction
WARNING
CONDUCTIVE CONNECTIONS — Extreme care must be
exercised when applying medical electrical equipment. Many parts
of the human/machine circuit are conductive, such as the patient,
connectors, electrodes, transducers. It is very important that these
conductive parts do not come into contact with other grounded,
conductive parts when connected to the isolated patient input of the
device. Such contact would bridge the patient's isolation and cancel
the protection provided by the isolated input. In particular, there
must be no contact of the neutral electrode and ground.
WARNING
DEFIBRILLATION — Do not come into contact with pati ents
during defibrillation. Otherwise serious injury or death could
result.
WARNING
DISCHARGE TO CLEAR PATIENT DA T A — When admitting a
new patient, you must clear all previous patient data from the
system. To accomplish this, disconnect patient cables then do a
discharge.
WARNING
DISCONNECTION FROM MAINS — When disconnecting the
system from the power line, remove the plug from the wall outlet
first. Then you may disconnect the power cord from the device. If
you do not observe this sequence, there is a risk of coming into
contact with line voltage by inserting metal objects, such as the
pins of leadwires, into the sockets of the power cord by mistake.
WARNING
DISPOSAL — Dispose of packaging material, observing the
applicable waste control regulations and keeping it out of
children’s reach.
1-4Dash® 3000/4000/50002000966-338A
Introduction
WARNING
EXPLOSION HAZARD — Do not use this equipment in the
presence of flammable anesthetics, vapors or liquids.
WARNING
WIRELESS COMMUNICATION INTERFERENCE — Wireless
LAN equipment contains an intentional RF radiator that has the
potential of interfering with other medical equipment, including
patient implanted devices.
Before installation and any time new medical equipment is added
to the Wireless LAN coverage area, complete the following tests:
Software version 5.3 or earlier — Perform the electromagnetic
compatibility test as described in the Wireless LAN
Configuration Guide.
Software version 5.4 or later — Perform the ad-hoc tests AND
the electromagnetic compatibility test as described in the
Wireless LAN Configuration Guide.
WARNING
INTERFACING OTHER EQUIPMENT — Devices may only be
interconnected with each other or to parts of the system when it has
been determined by qualified biomedical engineering personnel
that there is no danger to the patient, the operator, or the
environment as a result. In those instances where there is any
element of doubt concerning the safety of connected devices, the
user must contact the manufacturers concerned (or other informed
experts) for proper use. In all cases, safe and proper operation
should be verified with the applicable manufacturer's instructions
for use, and system standard EN 60601-1-1 must be complied with.
WARNING
— Before using the monitor for the first time, please read the
“Safety Statements” on page 1-2.
2000966-338ADash® 3000/4000/50001-5
Introduction
WARNING
INTRACARDIAC APPLICATION — When applyin g devices
intracardially, electrically conductive contact with parts connected
to the heart (pressure transducers, metal tube connections and
stopcocks, guide wires, etc.) must be avoided in all cases.
To prevent electrical contact, we recommend the following:
Always wear isolating rubber gloves.
Keep parts that are conductively connected to the heart
isolated from the ground.
Do not use tube fittings or stopcocks made of metal.
During intracardiac application of a device, a defibrillator and
pacemaker whose proper functioning has been verified must be
kept at hand.
WARNING
LEAKAGE CURRENT TEST — When interfacing with other
equipment, a test for leakage current must be performed by
qualified biomedical engineering personnel before using with
patients.
WARNING
PA TIENT AMBULATION — A patient must be assisted if
ambulating with a roll-stand mounted monitor.
WARNING
POWER SUPPLY — The device must be connected to a properly
installed power outlet with protective earth contacts only. If the
installation does not provide for a protective earth conductor,
disconnect the monitor from the power line and operate it on
battery power, if possible.
All devices of a system must be connected to the same power
supply circuit. Devices which are not connected to the same circuit
must be electrically isolated when operated.
1-6Dash® 3000/4000/50002000966-338A
Introduction
WARNING
PROTECTED LEADWIRES — Only use protected leadwires
and patient cables with this monitor.
The use of unprotected leadwires and patient cables creates the
potential for making an electrical connection to ground or to a high
voltage power source which can cause serious injury or death to the
patient.
WARNING
RATE METERS — Keep pacemaker patients under close
observation. Rate meters may continue to count the pacemaker rate
during cardiac arrest and some arrhythmias. Therefore, do not rely
entirely on rate meter alarms.
WARNING
SITE REQUIREMENTS — For safety reasons, all connectors for
patient cables and sensor leads are designed to prevent inadvertent
disconnection, should someone pull on them.
Do not route cables in a way that they may present a stumbling
hazard.
For devices installed above the patient, adequate precautions must
be taken to prevent them from dropping on the patient.
2000966-338ADash® 3000/4000/50001-7
Introduction
Cautions
WARNING
— If an error message appears DURING operation, it is the
physician’s responsibility to decide whether the unit is still suitable
for patient monitoring. As a general rule, monitoring should only
continue in extremely urgent cases and under the direct supervision
of a physician. The unit must be repaired before being used again
on a patient.
If an error message appears AFTER power-up, the unit must be
repaired before being used on a patient.
WARNING
— If connecting a monitor to a central station, verify the alarm
system is functional by temporarily changing one of the alarm
limits to initiate an alarm.
Caution statements identify a potential hazard or unsafe practice which, if not
avoided, could result in minor personal injury or product/p roperty damage.
The following caution statements apply to this monitoring system:
CAUTION
ACCESSORIES (SUPPLIES) — To ensure patient safety, use
only parts and accessories manufactured or recommended by GE.
Parts and accessories used must meet the requirements of the
applicable EN 60601 series safety standards and essential
performance standards, and/or the system configuration must meet
the requirements of the EN 60601-1-1 medical electrical systems
standard.
CAUTION
ACCESSORIES (EQUIPMENT) — The use of ACCESSORY
equipment not complying with the equivalent safety requirements
of this equipment may lead to a reduced level of safety of the
resulting system. Consideration relating to the choice shall
1-8Dash® 3000/4000/50002000966-338A
Introduction
include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has
been performed in accordance to the appropriate EN 60601-1
and/or EN 60601-1-1 harmonized national standard.
CAUTION
BATTERY POWER — If a device equipped with an optio nal
battery pack will not be used or not be connected to the power line
for a period of over six months, remove the battery.
CAUTION
BEFORE INSTALLATION — Compatibility is critical to safe
and effective use of this device. Please contact your local sales or
service representative prior to installation to verify equipment
compatibility.
CAUTION
CO
PARAMETER INTERFERENCE — Capnostat CO2
2
sensors with a serial number 26104 or greater require a separation
distance of 0.25 meters (10 inches) from the Wireless LAN device
to minimize potential interference.
CO
sensors with a serial number less than 26104 require a
2
separation distance of 2.5 meters (8.2 feet) and are not
recommended for use on monitoring equipment equipped with the
Wireless LAN option.
CAUTION
DEFIBRILLATOR PRECAUTIONS — Patient signal inputs
labeled with the CF and BF symbols with paddles are protected
against damage resulting from defibrillation voltages. To ensure
proper defibrillator protection, use only the recommended cables
and leadwires.
Proper placement of defibrillator paddles in relation to the
electrodes is required to ensure successful defibrillation.
2000966-338ADash® 3000/4000/50001-9
Introduction
CAUTION
DISPOSABLES — Disposable devices are intended for single use
only. They should not be reused as performance could degrade or
contamination could occur.
CAUTION
DISPOSAL — At the end of its service life, the product described
in this manual, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such
products. If you have questions concerning disposal of the product,
please contact GE or its representatives.
CAUTION
ELECTROCAUTERY PRECAUTIONS — To prevent unwanted
skin burns, apply electrocautery electrodes as far as possible from
all other electrodes, a distance of at least 15 cm/6 in. is
recommended.
CAUTION
ELECTRODES — Whenever patient defibrillation is a
possibility, use non-polarizing (silver/silver chloride construction)
electrodes for ECG monitoring. Polarizing electrodes (stainless
steel or silver constructed) may cause the electrodes to retain a
residual charge after defibrillation. A residual charge will block
acquisition of the ECG signal.
CAUTION
EMC — Magnetic and electrical fields are capable of interfering
with the proper performance of the device. For this reason make
sure that all external devices operated in the vicinity of the monitor
comply with the relevant EMC requirements. X-ray equipment or
MRI devices are a possible source of interference as they may emit
higher levels of electromagnetic radiation.
1-10Dash® 3000/4000/50002000966-338A
Introduction
CAUTION
INSTRUCTIONS FOR USE — For continued safe use of this
equipment, it is necessary that the listed instructions are followed.
However, instructions listed in this manual in no way supersede
established medical practices concerning patient care.
CAUTION
LOSS OF DATA — Should the monitor at any time temporarily
lose patient data, the potential exists that active monitoring is not
being done. Close patient observation or alternate monitoring
devices should be used until monitor function is restored.
If the monitor does not automatically resume operation within 60
seconds, power cycle the monitor using the power on/off switch.
Once monitoring is restored, you should verify correct monitoring
state and alarm function.
CAUTION
MAINTENANCE — Regular preventative maintenance should
be carried out annually. You are responsible for any requirements
specific to your country.
CAUTION
MPSO — The use of a multiple portable socket outlet (MPSO)
for a system will result in an enclosure leakage current equal to the
sum of all individual earth leakage currents of the system if there is
an interruption of the MPSO protective earth conductor. Do not use
an additional extension cable with the MPSO as it will increase the
chance of the single protective earth conductor interruption.
CAUTION
NEGLIGENCE — GE does not assume responsibility for damage
to the equipment caused by improperly vented cabinets, improper
or faulty power, or insufficient wall strength to support equipment
mounted on such walls.
2000966-338ADash® 3000/4000/50001-11
Introduction
CAUTION
OPERATOR — Medical technical equipment such as this
monitor/monitoring system must only be used by persons who
have received adequate training in the use of such equipment and
who are capable of applying it properly.
CAUTION
POWER REQUIREMENTS — Before connecting the device to
the power line, check that the voltage and frequency ratings of the
power line are the same as those indicated on the unit's label. If
this is not the case, do not connect the system to the power line
until you adjust the unit to match the power source.
In U.S.A., if the installation of this equipment will use 240V rather
than 120V, the source must be a center-tapped, 240V, single-phase
circuit.
This equipment is suitable for connection to public mains as
defined in CISPR 11.
CAUTION
RESTRICTED SALE — U.S. federal law restricts this device to
sale by or on order of a physician.
CAUTION
SINGLE PATIENT USE — This equipment is designed for use
on one patient at a time. Using this equipment to monitor different
parameters on different patients at the same time compromises the
accuracy of data acquired.
CAUTION
SUPERVISED USE — This equipment is intended for use under
the direct supervision of a licensed health care practitioner.
1-12Dash® 3000/4000/50002000966-338A
Notes
Introduction
CAUTION
VENTILATION REQUIREMENTS — Set up the device in a
location which affords sufficient ventilation. The ventilation
openings of the device must not be obstructed. The ambient
conditions specified in the technical specifications must be ensured
at all times.
Note statements provide application tips or other useful information.
The following note statements apply to this monitoring system:
Put the monitor in a location where you can easily see the screen and access the
operating controls.
This product is not likely to cause abnormal operation of other patient-
connected equipment such as cardiac pacemaker or other electrical stimulators.
Exceptions are noted in the pacemaker monitoring section, if applicable.
This product is protected against the effects of cardiac defibrillator discharges to
ensure proper recovery, as required by test standards. (The screen may blank
during a defibrillator discharge but recovers within seconds as required by test
standards.)
This equipment is suitable for use in the presence of electrosurgery.
Users should be aware of a possible time discrepancy between the waveforms
from the telemetry device and the waveforms hardwired to the monitor. Users
should not consider these waveforms to be synchronous. If absolute
synchronicity is desired, COMBO mode should be discontinued and the ECG
waveforms should be acquired via the hardwired bedside monitor.
The ambient conditions specified in the technical specifications of the service
manual must be ensured at all times.
Connect the power cord supplied with the monitor. Use only the original cord or
an equivalent one.
For measurements in or near the heart, GE recommends connecting the monitor
to the equipotential stud. Use the green and yellow potential equalization cable
and connect it to the equipotential stud on the back of the monitor.
Contact customer service engineers to connect monitors to a central station.
Monitors may be shipped with protective covers to protect unused parameter
connector inputs from dust and liquids. Do not remove the protective covers;
the parameter connectors will not function without them.
2000966-338ADash® 3000/4000/50001-13
Introduction
Equipment Symbols
NOTE
Some symbols may not appear on all equipment.
ATTENTION: Consult accompanying documents.
CAUTION: To reduce the risk of electric shock, do NOT remove cover. Refer servicing to
qualified service personnel.
TYPE CF APPLIED PART: Isolated (floating) applied part suitable for intentional external
and internal application to the patient including direct cardiac application. “Paddles”
outside the box indicate the applied part is defibrillator proof.
[Medical Standard Definition:] F-type applied part (floating/isolated) complying with the
specified requirements of EN 60601-1/UL 60601-1/CSA 601.1 Medical Standards to
provide a higher degree of protection against electric shock than that provided by type BF
applied parts.
TYPE BF APPLIED PART: Isolated (floating) applied part suitable for intentional external
and internal application to the patient excluding direct cardiac application. “Paddles”
outside the box indicate the applied part is defibrillator proof.
[Medical Standard Definition:] F-type applied part (floating/isolated) complying with the
specified requirements of EN 60601-1/UL 60601-1/CSA 601.1 Medical Standards to
provide a higher degree of protection against electric shock than that provided by type B
applied parts.
NOTE
The rating of protection against electric shock (indicated by symbol for CF or BF) is
achieved only when used with patient applied parts recommended by GE.
TYPE B APPLIED PART: Non-isolated applied part suitable for intentional external and
internal application to the patient excluding direct cardiac application.
[Medical Standard Definition:] Applied part complying with the specified requirements of
EN 60601-1/UL 60601-1/CSA 601.1 Medical Standards to provide protection against
electric shock, particularly regarding allowable leakage current.
1-14Dash® 3000/4000/50002000966-338A
Introduction
Fuse
Equipotential Stud: A ground wire from another device can be tied here to ensure the
devices share a common reference point.
Alternating current (AC)
Power
Indicates where to press to open the writer door.
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
Equipment Compliance Information
EN 60601-1 Component Classification
The following components meet EN 60601-1 classification standards.
2000966-338ADash® 3000/4000/50001-15
Introduction
Type of
protection
against
electrical
1
shock
Degree of protection against
electrical shock
2
Degree of
protection
against
harmful
ingress of
3
water
Degree of
safety of
application in
the presence
of a flammable
anesthetic
mixture with
air or with
oxygen or
nitrous oxide
4
Method of
sterilization/
disinfection
recommended
by the
manufacturer
Mode of
Operation
Monitor
BF (NBP, SpO
, CO2)
2
I
CF (ECG, Resp, IP, Temp/CO)
ICG Module
BF
N/A
SAM ModuleB
OrdinaryNot SuitableN/AContinuous
PRN-50 WriterI
Remote ControlN/A
TRAM-RAC 2A
I
Not Marked
(powered)
1
The class of equipment — I or N/A (not applicable).
2
The type of applied part — B, BF, CF, Not Marked or none (no applied parts).
3
Ordinary equipment (enclosed equipment without protection against the ingress of water).
4
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.
Underwriters Laboratories, Inc. Classification
Medical Equipment
With respect to electric shock, fire and mechanical hazards only in accordance with
UL 60601-1 and CAN/CSA C22.2 NO.601.1.
AAMI EMI Environment Recommendations
Review the AAMI EMC Committee technical information report (TIR-18) titled
Guidance of electromagnetic compatibility of medical devices for clinical/
biomedical engineers - Part 1: Radiated radio-frequency electromagnetic energy.
This TIR provides a means to evaluate and manage the EMI environment in the
hospital.
The following actions can be taken.
1-16Dash® 3000/4000/50002000966-338A
Loading...
+ 280 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.