Important: Be sure to fully read this manual before using the Cardiac Science 5300 and
5350 Vital Signs Monitor to ensure correct and safe use. After you have read this manual,
store it near the monitor so that it can be used for reference.
Information in this document is subject to change without notice. Names and data used in
the examples are fictitious unless otherwise noted.
Trademark Information
Cardiac Science, the Shielded Heart logo, Quinton, Burdick, and HeartCentrix are
trademarks of Cardiac Science Corporation.
OMRON® is a registered trademark of OMRON CORPORATION.
SMART INFLATION™ is a trademark of OMRON HEALTHCARE, Inc.
Nellcor® is a registered trademark of Nellcor Puritan Bennett Incorporated.
OXISENSOR® is a registered trademark of Nellcor Puritan Bennett Incorporated.
DURASENSOR® is a registered trademark of Nellcor Puritan Bennett Incorporated.
MAX-FAST® is a registered trademark of Mallinckrodt Inc.
TurboTemp® is a registered trademark of Cardinal Health 303, Inc.
Masimo® is a registered trademark of Masimo Corporation.
Alaris® and IVAC® are registered trademarks of Cardinal Health 303, Inc.
All other product and company names are trademarks or registered trademarks of their
respective companies.
◆Vital signs monitor orderable part number legend1-3
◆Warn in g s a nd ca uti on s1-5
◆Symbols and labels1-13
Thank you very much for choosing a Cardiac Science 5300 or 5350 vital signs monitor.
This chapter contains important safety and care information.
Cardiac Science provides customer service and technical support.
◆To order additional product or accessories, contact Customer Care.
◆For assistance with the product or installation, contact Technical Support.
Customer Care Technical Support
(800) 426 0337 (USA)
(425) 402 2000 (USA and Canada)
care@cardiacscience.com
(800) 426 0337 (USA)
(425) 402 2000 (USA and Canada)
techsupport@cardiacscience.com
http://websupport.cardiacscience.com/webchat/
Cardiac Science 5300/5350 Vital Signs Monitor70-00582-01 A
1-1
Safety
Intended use
The Cardiac Science 5300/5350 Vital Signs Monitor is intended to monitor a single
patient’s vital signs in the hospital, acute care settings, outpatient surgery, healthcare
practitioner facilities or in an environment where patient care is provided by qualified
healthcare personnel who will determine when use of this device is indicated, based upon
their professional assessment of the patient’s medical condition. The patient populations
include adult, pediatric and neonatal. The device is capable of monitoring:
◆Pulse rate (via oximetry data)
◆Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
◆Te m p e ra t u r e
◆Blood Oxygen Saturation (SpO
via finger oximeter)
2
This device is intended for use by qualified healthcare personnel trained in its use.
The symbols shown below identify potential hazard categories. The definition of each
category is as follows:
DANGER!
This alert identifies hazards that will cause serious personal injury or death.
WAR NING!
This alert identifies hazards that may cause serious personal injury or death.
Caution
This alert identifies hazards that may cause minor personal injury, product damage, or
property damage.
Warnings and cautions
General warnings and cautions
WAR NING!
Only properly trained medical personnel should use this device. Do not allow patients to
operate this device.
WAR NING!
If the monitor cannot take a measurement or the measurement readings seem dubious,
check the condition of the patient first.
WAR NING!
If any abnormality is found in the patient or the device, take appropriate measures, such as
stopping the device, to ensure the safety of the patient.
Caution
Before use, thoroughly read this Instruction Manual and the manuals supplied with
accessories and options to ensure correct use.
Caution
When any of the following occur, remove all accessories (cuffs, probes, etc.) from the patient,
turn the power OFF, and unplug the AC adapter cable from the AC socket.
•There is smoke or a strange odor leaking out of the device.
•The device has been dropped or impacted by an object.
•Liquid or foreign matter gets inside the device.
•If you think the device may be broken.
Cardiac Science 5300/5350 Vital Signs Monitor70-00582-01 A
1-5
Safety
!
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!
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Caution
If there is condensation on the device, dry it thoroughly before turning the power ON.
Caution
Follow your facility's procedures and applicable regulations when disposing of anything that
has been used on patients.
Caution
Observe the following points when using a defibrillator.
•Have everyone in the area stand back from the patient and from any cords and
devices connected to the patient. Otherwise, they could receive an electrical shock
from the energy conducted by the defibrillator.
•Stand as far away as possible from the electrodes mounted on the chest section
when applying the defibrillation or switch the electrodes to an appropriate
position. Applying defibrillation with the defibrillator paddles touching the
electrodes will cause burns.
Caution
Observe the following points when using electrosurgical/cautery equipment.
•If the electrode and ground pad are not properly mounted, they may cause burns
where they are attached to the patient.
For details, carefully read the cautions in the electrosurgical/cautery equipment operation
manual.
•Noise from the electrosurgical/cautery equipment may cause incorrect
measurements to be displayed.
1-6
Caution
Always carry out pre-work inspections and maintenance inspections.
Caution
Do not open, disassemble or alter the device.
Caution
The 5300/5350 series conforms to the requirements of the EMC standard (IEC 60601-12:2001), so it can be used at the same time as other electrical simulators. However, it may be
affected by electrical scalpels and microwave treatment devices and there may be an impact
on measurement precision for patients using cardiac pacemakers and the like.
Check the operation of this device during and after use of such equipment and with such
patients.
Do not take or use the device in locations where combustible anesthetics or flammable
gases are used or in high-pressure oxygen rooms or inside oxygen tents.
WAR NING!
Use with the specified AC voltage and frequency.
WAR NING!
Use a grounded AC outlet for the power supply and ground this device.
WAR NING!
Do not connect a grounding wire to a gas pipe or water pipe.
WAR NING!
For accessories mounted on the patient, optional parts, and consumables, use only those
supplied or specified by Cardiac Science.
WAR NING!
Do not plug the AC adapter cable into an AC outlet (or unplug it) with wet hands.
Caution
Do not install this device in the following locations:
•Locations where gases and flames are used
•Locations where the air includes dust, salt, or sulfur
•Locations exposed to prolonged direct sunlight
•Locations where water and steam may come into contact with device
•Locations that vibrate or are subject to sharp impacts
•Locations near heating equipment
•Locations where chemicals are stored
•This device can not be used in any room in which noise-generating apparatuses are
used (such as an MRI room, CT room, X-ray room, etc.)
Caution
Do not place anything on this device.
Caution
Before moving this device, remove all accessories from the patient, turn the power OFF, and
unplug the AC adapter cable.
Cardiac Science 5300/5350 Vital Signs Monitor70-00582-01 A
1-7
Safety
!
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Caution
Observe the following cautions when connecting this device with other equipment:
•Ensure that the connected equipment is in accordance with the IEC60601-1 or IEC
safety standards.
•Employ additional protective measures (e.g., additional protective earthing) as
necessary.
Caution
This device meets the restricted level of leakage current required for medical devices.
Therefore, this device cannot be connected to a device that would give a combined total of
leakage current beyond the restricted level. Do not connect devices that do not meet
medical safety standards.
NIBP
WAR NING!
Do not wrap the cuff around any of the following locations. Doing so can cause an accident.
•Anywhere on the four limbs that a venous pulse is secured, such as where there is
an IV or blood transfusion
•Any limb with an artificial dialysis shunt
WAR NING!
When the cuff hose is bent or blocked, there could still be air in the cuff even though the
pressure display reads 0mmHg. This may block the blood flow in the arm, which may in turn
cause peripheral function disorders.
Caution
Never set the measurement mode to Adult/Pediatric when using a neonate/infant cuff.
Doing so could cause the cuff to be inflated to a dangerously high pressure.
Caution
Check at least every eight hours to see that there is no abnormality or damage to the area
measured. If there is, change the measurement site, as failure to do so may lead to patient
perspiration-related inflammation or damage.
Caution
With any patient whom the doctor has pointed out as having a tendency to bleed or hypercoagulate, circulatory obstruction due to a thrombus or clot, hemorrhage may occur after
measurement.
Caution
Do not measure continuously for a long time. This can cause extremity function obstruction.
Caution
If the cuff is touched or the patient moves, the device may interpret that the inflation
pressure is insufficient and inflate to high pressure.
In the following cases, pressurization may rupture the cuff bladder:
•If a cuff is used with a frayed cuff cover.
•If a blood pressure measurement starts with the cuff not wrapped around an arm.
•If the cuff measurement interval is not set to OFF when cuff is removed from the
patient.
Caution
Always follow your facility's infection control procedures and applicable regulations when
disposing of anything that has been used on patients.
SpO
2
Caution
Do not look at the light from the SpO
Caution
If the adhesive tape irritates the patient's skin, stop using it.
sensor for a long period of time.
2
Caution
Do not fasten sensors with tape. This can cause hemostasis or edema.
Caution
•The SpO
location changed when abnormality is observed. For a patient with extremity or
circulatory obstruction, failure to change the sensor location can cause a rash lowtemperature burn, or other problems.
•SpO
•Do not insert the finger too far into the sensor. Doing so could cause injury.
Caution
This device has no alarm function for SpO
Caution
For models with Masimo® SpO
Possession or purchase of this device does not convey any express or implied license to use
the device with unauthorized sensors or cables which would, alone or in combination with
this device, fall within the scope of one more of the patents relating to this device.
sensor should be checked every two to three hours, and the sensor
2
sensors (single-patient use only) can be reused only with the same patient.
2
. (5300 only)
2
2
Cardiac Science 5300/5350 Vital Signs Monitor70-00582-01 A
1-9
Safety
!
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Te mp er at ure
Caution
For best product performance and measurement accuracy, use only accessories supplied or
recommended by Cardiac Science. Use accessories according to the manufacturer's
directions for use.
Caution
Never reuse a probe cover. Doing so would create a danger of infection.
Caution
When measuring in the mouth cavity, be careful not to damage any mucous membrane.
Caution
To avoid injury, only use probes according to the manufacturer's directions for use.
Caution
Be careful when using probes for children and neonates.
Caution
When measuring in the mouth cavity, make sure the patient does not swallow the probe or
probe cover.
Caution
If the body temperature is measured without the probe cover, there is a danger of infection,
allergic reaction or injury of the person being measured. Do not measure body temperature
without using a probe cover.
Alarm
(Cardiac Science 5350 only)
Caution
Set the alarm volume loud enough to be heard adequately in the actual use environment.
Caution
If the alarm sounds, first check the patient's condition.
Caution
For the alarm range, set the value appropriate to the patient to whom this device is attached.
In the following cases, battery solution could erupt out of the battery and cause heating, fire,
and rupture:
•If the battery is thrown into a fire or overheated
•If the battery is disassembled or altered
•If a battery that is leaking, deformed, or discolored is used
•If the battery unit is subject to strong mechanical shock
•If the battery is forced into the device main unit
•If the + and – terminals of the battery are connected with a metal needle or the like
•If the battery is carried together with a metal object, such as a metal necklace or hair
pin
•If the battery is charged in any manner other than that specified
DANGER!
If battery solution comes into contact with skin or clothing, wash it off with clean water. If
battery solution comes into contact with the eye, rinse the eye out thoroughly with clean
water and seek immediate medical attention. There is a danger of loss of eyesight.
Caution
Keep water off the battery and do not allow it to become wet. If the battery gets wet, rust
may be generated and leakage may then occur.
Caution
Do not leave the battery unused for a prolonged period of time (more than two years).
Doing so could cause battery solution leakage.
Caution
Do not leave a battery mounted in the main unit if the use time between charges has
become short or the battery has stopped working. Doing so could result in battery solution
leaking within the battery unit causing corrosion and fire.
Caution
The battery used in the battery unit is a lead acid battery. Follow local government
ordinances and recycling instructions regarding disposal or recycling of batteries.
Maintenance
Caution
Before conducting maintenance work, turn the power OFF and unplug the AC adapter cable
from the AC socket to prevent electric shock.
Caution
Do not soak the main unit or accessories in any medical liquid. Also, keep liquids out of the
main unit and accessories.
Cardiac Science 5300/5350 Vital Signs Monitor70-00582-01 A
1-11
Safety
!
!
!
Caution
When using disinfectant solutions, follow the manufacturer’s directions.
Caution
After cleaning, allow complete drying before plugging in.
Caution
Using this device with the ventilation port blocked could cause a breakdown.
Clean this device with care.
Other labels
SymbolDescription
This symbol appearing in the text indicates that a highest-priority alarm
sounds in association with the error content. When the alarm sounds, switch
the power OFF, then ON again.
Highest-priority rhythm.
Continues to sound until power is cut off.
This symbol appearing in the text indicates that a high-priority alarm sounds
in association with the error content. Take appropriate measures if the alarm
sounds.
At this time, the measurement reading will be displayed flashing.
The format of the high-priority alarm is as follows.
This alarm is sounded twice at 8 second
intervals.
This symbol appearing in the text indicates that a medium-priority alarm
sounds in association with the error content. Measurement is prevented if
this alarm sounds. Check the patient and the machine. The measurement
reading will be displayed flashing.
The format of the medium-priority alarm is as follows.
This alarm is sounded twice
at 24 second intervals.
Cardiac Science 5300/5350 Vital Signs Monitor70-00582-01 A
2-1
Outline
Configured products
Before using the 5300/5350 series monitor be sure to check that all of the accessories are
included and that the main unit and accessories are not damaged. If, for some reason, the
contents are not complete, please contact Cardiac Science.