Fukuda Denshi Dynascope 8000 Series User manual

i
Preface
Thank you for purchasing our Monitor.
Read the “Safety Precautions” thoroughly before use to ensure correct
and safe use of the product.
Important Notice····································· ii
For Safe Operation of the Equipment ······· ii
Intended Use of this Equipment ·············· ii
Maintenance, Repair, Replacement ········· ii
Contact··············································iii
Expression Used in This Manual ·············iii
Safety Precautions································· iv
Warning Label···································· iv
Measurement Unit for Each Parameter····· v
Graphic Symbols ································ vi
Precautions for Safe Operation of Medical
Electrical Equipment···························· ix
Precautions about the Maintenance········· x
Precautions about Medical Telemetry ····· xi
Precautions about the Pacemaker········· xiii
Non-Explosion Proof ·························· xiv
Precautions about Magnetic Resonance
Imaging ··········································· xiv
Defibrillation Safety ···························· xiv
Electrosurgery Safety ··························xv
Precautions about Connections to
Peripheral Devices····························· xvi
Accessories and Optional Accessories ··· xvi
Precautions about the DSL-8001 ········· xvii
Precautions about the Ventilator Monitoring
···················································· xxiv
Precautions about Use of the SpO2Sensor
····················································· xxv
Precautions for Use of NIBP Cuff ········· xxv
Disposing of Equipment, Accessories, or
Components ···································· xxv
Precautions about Transportation········ xxvi
Precautions about RTC or Data Backup xxvi
To Prepare for Emergency Use ·········· xxvi
Electromagnetic Compatibility ············ xxvii
Precautions for Safe Operation under
Electromagnetic Influence ·················xxvii
EMC Guidance······························· xxviii
Compliance to the Electromagnetic
Emissions ······························ xxviii
Compliance to the Electromagnetic
Immunity (1) ···························· xxix
Compliance to the Electromagnetic
Immunity (2) ····························· xxx
Recommended Separation Distances
between Portable and Mobile RF
Communications Equipment and the
DSL-8001 System ···················· xxxi

ii
Important Notice
For Safe Operation of the Equipment
(1) Before using this equipment, read this operation manual.
(2) Fukuda Denshi cannot predict all the dangers which may be caused by
misusage of this product or environmental condition.
(3) For using this equipment, there are many items that "should be performed",
"should not be performed", and "cannot be performed". It is not possible to
cover all these items in this manual or warning labels. Therefore, it is
necessary to also follow the general safety precaution other than the items
described in this manual.
(4) To prevent accidents, usage other than intended, or usage, cleaning, and
maintenance not described in this manual should not be performed.
(5) When using this equipment, follow the respective regulation to minimize the
probability of accidents.
Intended Use of this Equipment
This equipment is designed for the following <Intended Use>.
<Intended Use>
This equipment is intended for measuring parameters such as ECG (waveform
and heart rate), respiration, NIBP, temperature, SpO2, pulse rate, and pulse wave,
and monitors patient condition by displaying/printing the measurement data on
this equipment or central monitor and generates alarm as required.
For specification of this equipment, refer to "Chapter 9 Technical Information" of
this Operation Manual.
The operation and maintenance of this equipment should be performed by
well-trained and authorized personnel. Also, your local regulation must be
followed. If this equipment is used for the purpose other than intended, or if the
user does not follow the safety instructions, the following hazard may result.
Hazard to the Life and Health of the Patient or the User
A Problem Related to Medical Practice
Damage to the Equipment
Maintenance, Repair, Replacement
Fukuda Denshi is liable for the safety, reliability, and performance of its
equipment only if;
Maintenance, modifications, and repairs are carried out by authorized
personnel or organization.
Components are used in accordance with Fukuda Denshi operating
instructions.
A full technical description of the DSL-8001 system is available from your local
Fukuda Denshi sales representative.

iii
Contact
If you need more detailed information, please contact following.
(1) Fukuda Denshi Co., Ltd., Head Office
3-39-4 Hongo, Bunkyo-ku, Tokyo, 113-8420, Japan
Phone:[phone] Fax:[phone]
E-mail: [email protected]
Home Page: http://www.fukuda.com
(2) Sales Representative
Write the name, address, phone, fax number of your local sales
representative.
(Name of Sales Representative, Address, Phone/Fax)
Expression Used in This Manual
Meaning of the Symbols
Type of
Precaution Description
DANGER Failure to follow this message may cause immediate threat
of death or serious injury.
WARNING Failure to follow this message may result in death or
serious injury.
CAUTION Failure to follow this message may cause injury or failure to
the equipment.
NOTE Used to emphasize important information.
Reference Used to provide useful information.
* Used in a table which indicates that there is detailed
explanation outside the table.
Indications for the screens and keys
Fixed keys and selections on the setup window are indicated by [ ].
(Example: [Menu] or [ON]/[OFF])
The expressions displayed on the monitor screen item names on the setup
window will be indicated by " ".
(Example: "Volume" or "Patient Setup" window)
The messages displayed on the screen are indicated by < >.
(Example: <Low Battery>, <Alarm Sound Suspend>)

iv
Safety Precautions
Read the “Safety Precautions” thoroughly before use to ensure correct and
safe use of the product.
Make sure to follow the precautions indicated below, as these are important
messages related to safety.
DANGER Failure to follow this message may cause immediate threat
of death or serious injury.
WARNING Failure to follow this message may result in death or
serious injury.
CAUTION Failure to follow this message may cause injury or failure to
the equipment.
Warning Label
Make sure to read the warning labels attached to the unit and comply with these
requirements while operating the unit.
CAUTION
Do not damage or erase the warning label attached to the
equipment.
This warning label contains important descriptions for
handling and operating the equipment properly and safely. A
damaged label may compromise safe operation.
DSL-8001 System Main Unit

v
Measurement Unit for Each Parameter
The measurement units for this equipment are as follows.
Description Parameter Display Unit Default
Heart Rate /
Pulse Rate
ECG HR
bpm
(beats per minute)
NIBP PR bpm
SpO2PR bpm
Respiration
Rate
Impedance
Respiration RESP Bpm (breaths per minute)
Arterial
Oxygen
Saturation
SpO2SpO2%
Non-Invasive
Blood
Pressure
Non-Invasive
Blood
Pressure
NIBP mmHg / kPa mmHg
Temperature Temperature TEMP C / °F C

vi
Graphic Symbols
Refer to the following for the meaning of the symbols indicated on the equipment.
DSL-8001 System
Symbol Description
Caution, refer to accompanying documents
Indicates the need to refer to related accompanying
documents before operation.
Refer to accompanying documents
Indicates the need to refer to related accompanying
documents before operation.
Potential Equalization Terminal
Indicates the terminal to equalize the potential difference
when interconnecting devices.
Power ON/OFF
Type CF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock,
which is Type CF Applied Part with defibrillation-proof.
Signal Output Part
Alarm Silence Key
NIBP Start/Stop Key
NIBP Measurement Interval Setup Key
Home Key
Menu Key
Print Key
Year of Manufacture
Indicates the manufactured year.

vii
Symbol Description
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic
equipment.

viii
Symbols displayed on the DSL-8001 screen
Symbol Description Symbol Description
NIBP Elapsed Time
Pulse Amplitude
Display
Alarm Silence Icon
Alarm Sound
Suspend Icon
Main Menu Icon
Alarm OFF Icon
Alarm Limit Setup Icon
Ventilator Status Switch Display Icon
Message Icon Table/Trend Icon
Patient Classification:
Adult
Remaining Battery
Power Icon
Patient Classification:
Child
Previous Screen Icon
Patient Classification:
Neonate
Next Screen Icon
SEC Alarm Indicator
Newest Screen Icon

ix
Precautions for Safe Operation of Medical Electrical
Equipment
CAUTION
Read the following precautions thoroughly to correctly
operate the equipment.
Users should have a thorough knowledge of the operation
before using this equipment.
Pay attention to the following when installing and storing the
equipment.
Do not install or store in an area where the equipment will
be subject to splashing water.
Do not install or store in an area where the environmental
conditions, such as atmospheric pressure, temperature,
humidity, ventilation, sunlight, dust, sodium, sulfur, will
adversely affect the equipment.
Place the equipment on a stable surface where there is no
inclination, vibration, or shock (including during
transportation).
Do not install or store in an area where chemicals are
stored or gasses are evolved.
Verify the power frequency, voltage and allowable current
(or power consumption).
Ensure the grounding is proper by connecting the
accompanying power cable to the hospital grade outlet.
Before operating the equipment, verify the following items.
Verify the power voltage.
Check the cable connection and polarity to ensure proper
operation of the equipment.
Make sure the power system has adequate earth ground.
Ensure that all cables are firmly and safely connected.
Pay special attention when the device is used in
conjunction with other equipment as it may cause
erroneous judgment and danger.
Ensure all patient connections are proper and secure.
During operation of the equipment, verify the following items.
Always observe the equipment and patient to ensure safe
operation of the equipment.
If any abnormality is found on the equipment or patient,
take appropriate measures such as ceasing operation of
the equipment in the safest way for the patient.
Do not allow the patient to come in contact with the
equipment.
Do not touch any of the signal input or output parts at the
same time as the patient.

x
CAUTION
After using the equipment, verify the following items.
Unplug all the cables from the patient before turning off the
power.
When unplugging the cables, do not apply excessive force
by pulling on the cable. Pull from the connector part of the
cable.
Clean the accessories and cables, and keep them
together in one place.
Keep the equipment clean to ensure proper operation for
the next use.
If the equipment is damaged and in need of repair, stop using
the equipment, label it “OUT OF ORDER” and contact
Fukuda Denshi.
Do not disassemble or remodel the equipment.
Maintenance Check
Make sure to periodically check the equipment,
accessories and cables.
Before reusing the equipment that has been left unused for
a while, make sure that the equipment works normally and
safely.
To prevent patient from burn injury, verify proper attachment
of patient ground plate, ECG electrode type when using the
electrosurgical knife, and verify paste volume, output energy
when using the defibrillator. Also, verify that proper ground is
selected.
Precautions about the Maintenance
Safety Inspection and Maintenance
For safe operation of the equipment, regular inspection and maintenance are
required. Once a year, check all cables, devices, and accessories for damage,
earth impedance, earth and leakage currents, and all alarm functions. Also,
ensure that all safety labels are legible. Maintain a record of these safety
inspections.
Immediate maintenance has to be carried out if;
the equipment was subjected to extreme mechanical stress, e.g. after a
heavy fall.
the equipment was subjected to liquid spill.
the monitoring function is interrupted or disturbed.
parts of the equipment enclosure are cracked, removed, or lost.
any connector or cable shows signs of deterioration.
Reference Refer to “8. Maintenance” for details.
WARNING
Never open the housing while the equipment is in operation or
connected to hospital grade outlet as it may result in electric
shock.

xi
Maintenance, Modifications, and Repairs
Fukuda Denshi is liable for the safety, reliability, and performance of its
equipment only if;
Maintenance, modifications, and repairs are carried out by authorized
personnel.
Components are used in accordance with Fukuda Denshi operating
instructions.
A full technical description of the DSL-8001 system is available from your local
Fukuda Denshi representative.
Precautions about Medical Telemetry
DANGER
When monitoring a patient using wireless telemetry, make sure
the patient data is properly received at the central monitor. Pay
special attention when the channel ID at the bedside monitor is
changed.
WARNING
Depending on the wireless combinations, interference may
generate with other telemeters.
Before selecting a channel, verify it will not interfere with other
channels.
Make sure the telemetry manager of your system is aware of
any changes to the telemetry channels.
If transmitters are used in a neighboring medical facility, your
facility and the neighboring facility must make agreements on
the setting of the telemetry channels to prevent telemetry
interference.
CAUTION
Precautions about the Installation
The medical institution (hereinafter referred as
“Institution”) must decide the telemetry installation plan for
the medical institution in order to prevent interference and
interference between transmitters (telemetry based on
destination country’s radio law). When telemetry has
already been installed and been used, radio format,
frequency, and antenna power are required to be
examined to prevent interference.
When using telemetry which requires zone location, the
Institution is to set up the zones as an operation unit for
each transmitter to prevent electronic interference
between telemetry throughout the medical institution.
When using telemetry which requires zone location,
display and identify each prepared zone in the equipment.
When laying receiver antenna for each transmitter, the
Institution has to examine the installation so that electronic
interference does not occur.
Based on the above examination result, the Institution
should place each receiver antenna as required.

xii
CAUTION
Precautions about the Management
The institution appoints a person to manage the wireless
channels for the whole medical institution. And when using
telemetry which requires zone location, the Institution
should nominate a person to manage the wireless
channels in each zone (a “Zone Manager”). However,
when using such telemetry in a local medical institution,
one person can perform both functions.
Select a telemetry manager who understands the
characteristics and functionality of telemetry systems, and
is skilled in operating telemetry.
When installing telemetry, the Overall Manager and the
Zone Manager have to understand the precautions for use
of the telemetry in advance.
The Overall Manager takes responsibility of wireless
channel management and transmitter storage for the
whole Institution by giving proper instruction.
The Overall Manager should create a management log
(hereinafter referred to as the “log”), which contains a list
of the management status of the wireless channels for the
whole Institution. When changing a wireless channel,
register it in the log and give proper instructions to the
Zone Manager or to the user.
The Zone Manager assumes responsibility for managing
the wireless channels, storing, and managing telemetry.
The Zone Manager assigns the transmitter to the user, and
provides enough education for use inside the zone.
The telemetry user verifies operation of the
transmitter/receiver before use.
The telemetry user, if using the telemetry in a zone
location, follows the instructions of the Zone Manager for
the zone and gives instructions to the patient if required.
When interference or breakdown occurs in telemetry
communication, the user is required to inform the zone
manager and the overall manager of the problems. The
Zone Manager and Overall Manager are to deal with the
problem properly and/or contact their nearest Fukuda
Denshi representative for service.
Precautions about the Setting
Connection of the HLX-801 Telemetry Transmitter Module
will be performed by our service representative. Users
should not perform this procedure as malfunction of the
equipment may occur.
The setup of channel ID and group ID should be
performed only by the telemetry manager of your system
or our service representative. Users should not perform
this procedure as malfunction may occur.
On a wireless network, the alarm generated on this unit
will be transmitted to the central monitor with a maximum
of 15 seconds delay.

xiii
Precautions about the Pacemaker
WARNING
Minute ventilation rate-adaptive implantable pacemakers can
occasionally interact with certain cardiac monitoring and
diagnostic equipment, causing the pacemakers to pace at
their maximum programmed rate. The cardiac monitoring
and diagnostic equipment may possibly send wrong
information.
If such event occurs, please disconnect the cardiac
monitoring and diagnostic equipment, or follow the
procedures described in the operation manual of the
pacemaker.
For more details, contact FUKUDA DENSHI personnel, your
institution’s professionals, or your pacemaker distributors.
Rate meters may continue to count the pacemaker rate
during occurrences of cardiac arrest or some arrhythmias.
Do not rely entirely upon rate meter alarms. Keep pacemaker
patients under close surveillance. See this manual for
disclosure of the pacemaker pulse rejection capability of this
equipment.
See “Minute Ventilation Rate-Adaptive Pacemakers”
FDA alerts health professionals that minute ventilation
rate-adaptive implantable pacemakers can
occasionally interact with certain cardiac monitoring
and diagnostic equipment, causing pacemakers to
pace at their maximum programmed rate.
CAUTION
There are some cases when the pacemaker pulse can not be
detected depending on the pacemaker type, pulse voltage,
pulse width, electrode lead type (unipolar, bipolar), or
electrode placement which causes the pacemaker pulse
amplitude to decrease and disables the pacemaker pulse
detection.
If signals similar to a pacemaker pulse are present, such as
electric blanket noise or excessive AC frequency noise, these
may be erroneously detected and displayed as a pacemaker
pulse.
When a spontaneous QRS overlaps pacemaker pulse (e.g.
fusion beat, etc.), the heart rate will decrease because QRS
detection cannot be properly performed.
If a pacemaker pulse is continuously detected due to AC
frequency interference, QRS detection will be suspended
and the heart rate will be reduced.

xiv
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable
anesthetics, high concentration of oxygen, or inside hyperbaric
chamber. Also, do not operate the equipment in an environment
in which there is a risk of explosion.
Explosion or fire may result.
Precautions about Magnetic Resonance Imaging
WARNING
Do not use this equipment in magnetic resonance imaging (MRI)
environments. This equipment may be pulled towards the MRI
device. And the local heating by the induced electromotive force
may cause burn injury to the patient or deteriorate the
performance of this equipment.
Defibrillation Safety
WARNING
When defibrillating, keep away from the electrodes or
medicament applied to the patient chest. If this is not
possible, remove the electrodes or medicament before
defibrillating.
If the defibrillator paddles come directly in contact with the
electrodes or medicament, electrical shock may result from
the discharged energy.
When defibrillating, make sure that the electrodes, sensor
cables, or relay cables are firmly connected to the device.
Also, when using the equipment without using the battery,
make sure that the equipment has adequate earth ground.
Contacting the metal part of a disconnected cable may result
in electrical shock from the discharged energy.
When defibrillating, do not touch the patient or the metal part
of the device or cables. Electric shock may result from the
discharged energy.

xv
Electrosurgery Safety
WARNING
The monitoring system contains protection against interference
generated by electrosurgical instruments. However, operating
conditions, surgery site with respect to the location of ECG
electrodes, or the type of instrument used, may cause noise on
the ECG. Noise is generated at the tip of an electrical knife and
is difficult to completely eliminate because of the frequency
components of the ECG. To reduce electrosurgical interference,
take the following precautions:
Installation Location
Locate the electrosurgical unit as far as possible from this
unit and the patient cable. This will help reduce interference
on the ECG through the monitor or cables.
Power Supply
Connect the electrosurgical unit to a power supply that is
different from that of the monitor. This will help prevent
interference through the power cable.
Electrode Placement
The amount of interference is considerably different
depending on the electrode position and surgery site. Place
the ECG electrodes as far away as possible from the
surgery site and the ground plate. Do not place electrodes in
the path between the surgery site and the ground plate. If
the electrodes are placed in this path, the amount of
interference will be quite large. Position (+) and (–)
electrodes as close as possible to each other.
Ground Plate
When using electrosurgical instruments, make sure the
contact between the patient and the ground plate is secure.
If the connection is incomplete, the patient may suffer from
burn at the electrode site.

xvi
Precautions about Connections to Peripheral Devices
In the interest of safe and sufficient performance of this equipment, the
connection of other manufacturers’ equipment to the monitor is not authorized,
unless the connection is explicitly approved by Fukuda Denshi. It is the user’s
responsibility to contact Fukuda Denshi to determine the compatibility and
warranty status of any connection made to another manufacturer’s equipment.
WARNING
Regarding the connector with mark, only the peripheral
devices specified by Fukuda Denshi should be connected with
the given procedure. Use of an unspecified device may cause
electric shock to the patient and/or operator due to excessive
leakage current.
CAUTION
All the peripheral device connectors on the DSL-8001 system
are isolated from the power supply, but the peripheral devices
are not isolated. To prevent danger of electric shock, always
position the peripheral devices away from the patient.
When connecting peripheral devices to the DSL-8001 system, it is the user’s
responsibility to verify that the overall system complies with EN 60601-1-1/IEC
60601-1-1, “Collateral Standard: Safety Requirements for Medical Electrical
Systems”.
Accessories and Optional Accessories
WARNING
Use only the cables specified by Fukuda Denshi.
Use of other cables may result in an increase in emission
(generation of unwanted electromagnetic energy from this
equipment) or decrease in immunity (resistance to
electromagnetic interference generated from other devices).

xvii
Precautions about the DSL-8001
DANGER
When connecting other equipment, contact your nearest
representative.
Dangers such as electric shock may result to the patient and
operator.
WARNING
Do not connect any equipment or cable not authorized by
Fukuda Denshi to any I/O connector. If done so by mistake,
the device cannot deliver its maximum performance and the
connected units may be damaged, resulting in a safety
hazard.
The alarm output signal should not be used as the primary
source of alarm notification. The audible alarms of the
monitor, used in conjunction with clinical signs and
symptoms, are the primary sources for notifying medical
personnel that an alarm condition exists.
If the equipment is used in an environment that does not fulfill
the specified conditions, the equipment cannot deliver the
maximum performance, equipment may become damaged
and safety cannot be ensured. If using in an environment
other than the specified environment, contact our service
representative.
Use only the accompanying 3-way AC power cable. Use of
other cables may result in electric shock to the patient and
the operator.
The power cable must be connected to a hospital grade
outlet.
When using multiple ME equipment simultaneously, perform
equipotential grounding to prevent potential difference
between the equipments. Even a small potential difference
may result in electric shock to the patient and the operator.
Alarm Setup
Set the appropriate upper and lower alarm limit for each
parameter according to the monitoring condition.
When the upper/lower alarm limit of the individual
parameter is set to OFF（”- - -“）, alarm will not be
generated even if the individual parameter alarm is set to
ON. Be cautious when setting them OFF.
HR/PR alarm and HR zero alarm is independent and the
setting is not linked with each other.
RESP alarm and RR zero alarm is independent and the
setting is not linked with each other.
Rate meters may continue to count the pacemaker rate
during occurrences of cardiac arrest. Do not rely entirely
upon rate meter alarms. Keep pacemaker patients under
close surveillance. See this manual for disclosure of the
pacemaker pulse rejection capability of this equipment.

xviii
WARNING
The purpose of the RR zero alarm is to alert the user to
evaluate for the possible occurrence of apnea events by
identifying the absence of respiration. It is not intended to be
classified as an “Apnea Monitor” and will not identify the
condition creating the possible event. (Central, Obstructive or
Mixed)
SpO2Monitoring
When measuring the SpO2of patient with high fever or
peripheral circulatory insufficiency, check the sensor
attachment periodically and change the attachment site.
The temperature of attachment site will rise 2 to 3 C due
to the sensor heat which may result in compression
necrosis and burn injury.
For the following case, accurate measurement may not be
possible.
- Patient with excessive abnormal hemoglobin (HbCO,
MetHb)
- Patient with the pigment injected to the blood
- Patient receiving CPR treatment
- When a sensor is applied to a limb with NIBP cuff,
arterial catheter, or intracatheter
- When measuring at site with venous pulse
- Patient with body motion
- Patient with small pulse
NIBP Monitoring
Before the NIBP measurement, make sure the patient
classification ([Adult]/[Child]/[Neonate]) is properly
selected. Otherwise, correct measurement cannot be
performed, and congestion or other injury may result.
Night Mode Setup
When selecting [Silence] for Volume or [Time Only] for
Screen Brightness, pay attention not to miss any important
alarm by simultaneously monitoring the bed on other
monitors such as central monitor.