Cardiac Science 5300 User manual

Instruction Manual
Cardiac Science 5300 and
Cardiac Science 5350
Vital Signs Monitor
70-00582-01 A

CARDIAC SCIENCE 5300 AND
CARDIAC SCIENCE 5350
VITAL SIGNS MONITOR
INSTRUCTION MANUAL
70-00582-01 A
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.
© OMRON HEALTHCARE CO., Ltd. 2009. All Rights Reserved.
70-00582-01 A Cardiac Science 5300/5350 Vital Signs Monitor
ii
Cardiac Science Corporation
3303 Monte Villa Parkway
Bothell, WA 98021, USA
[phone] (USA and Canada)
[phone]
[email protected]
www.cardiacscience.com

Contents iii
Contents
Contents
Chapter 1: Safety
Intended use...........................................................................................1-2
Vital signs monitor orderable part number legend..................................1-3
Warnings and cautions...........................................................................1-5
Safety alert descriptions....................................................................1-5
General warnings and cautions ........................................................1-5
Installation.......................................................................................1-7
NIBP...............................................................................................1-8
SpO2...............................................................................................1-9
Temperature..................................................................................1-10
Alarm
(Cardiac Science 5350 only) ......................................................1-10
Internal Battery..............................................................................1-11
Maintenance..................................................................................1-11
Other labels ...................................................................................1-12
Symbols and labels ...............................................................................1-13
Chapter 2: Outline
Configured products ..............................................................................2-2
Main unit ........................................................................................2-2
Names and functions of parts.................................................................2-6
Main unit ........................................................................................2-6
Explanation of display......................................................................2-8
Chapter 3: Preparation
Preparations before use...........................................................................3-2
Installing the internal battery...........................................................3-2
Connecting the power supply ..........................................................3-3
Charging the internal battery ...........................................................3-4
Moving the device ...........................................................................3-4
Checking and revising the date and time..........................................3-5

Contents
iv
Contents
Chapter 4: Non-Invasive Blood Pressure Measurement
Measurement preparation.......................................................................4-2
Connecting the air hose ...................................................................4-2
Cuff selection...................................................................................4-2
Check before start of blood pressure measurement...........................4-3
Selecting the measurement mode .....................................................4-4
Cuff connection...............................................................................4-5
How to apply the cuff.............................................................................4-6
Attaching the cuff ............................................................................4-6
Attaching neonatal cuff....................................................................4-8
Manual measurement .............................................................................4-9
Commencing a measurement...........................................................4-9
Display of the measurement results................................................4-10
Automatic measurement
(Cardiac Science 5350 only) .............................................................4-11
Monitoring using cuff intervals......................................................4-11
Continuous measurement
(Cardiac Science 5350 only) .............................................................4-13
Continuous measurements (CON) ................................................4-13
Quick SYS .....................................................................................4-14
Other functions....................................................................................4-16
Initial inflation value......................................................................4-16
Initial inflation pressure value setting.............................................4-16
Elapsed time ..................................................................................4-19
Smart Inflation™ ............................................................................4-19
High speed measurement (default setting is OFF)..........................4-21
BP silent mode...............................................................................4-22
Blood pressure measurement end sound.........................................4-24
After measurement ...............................................................................4-25
Cuff measurement interval OFF
(Cardiac Science 5350 only) ......................................................4-25
Clear display
(Cardiac Science 5300 only) ......................................................4-27

Contents v
Contents
Chapter 5: Pulse Oximeter (SpO2)
Measurement preparation.......................................................................5-2
Connecting the SpO2sensor............................................................5-2
SpO2sensor selection ......................................................................5-4
Attaching SpO2sensor ...........................................................................5-7
Reusable SpO2sensor ......................................................................5-7
Disposable SpO2sensor...................................................................5-8
Measurement .........................................................................................5-9
Screen display example.....................................................................5-9
Chapter 6: Temperature Measurement
Measurement preparation.......................................................................6-2
Connecting the body temperature probe..........................................6-2
Measurement .........................................................................................6-3
Mounting the probe cover ...............................................................6-3
Mounting the body temperature probe............................................6-4
Screen display example.....................................................................6-5
Exiting measurement .......................................................................6-6
Chapter 7: List Screen
Explanation list screen............................................................................7-2
List data count .......................................................................................7-3
List save timing ......................................................................................7-3
Deleting list data ....................................................................................7-4
Delete list screen..............................................................................7-4
Exiting the setting screen .................................................................7-4
Exiting list display ..................................................................................7-5
Chapter 8: Alarms
Alarm settings
(Cardiac Science 5350 only)...............................................................8-2
About setting mode .........................................................................8-2
Alarm setting screens .......................................................................8-2
Changing the alarm setting value .....................................................8-3
Entering the alarm setting value.......................................................8-3
Exiting the setting screen .................................................................8-3
Alarm operations
(Cardiac Science 5350 only)...............................................................8-4
Alarm triggering...............................................................................8-4
Silencing an Alarm...........................................................................8-5

Contents
vi
Contents
Recovering from an alarm................................................................8-5
Extinguishing an alarm ....................................................................8-5
Alarm setting range..........................................................................8-6
Chapter 9: Recorder
Preparations before use...........................................................................9-2
Setting up the roll paper ..................................................................9-2
Manual recording...................................................................................9-3
List types..........................................................................................9-3
Simple list recording (LST 1)...........................................................9-4
Detailed list recording (LST 2) ........................................................9-5
Measurement value recording (OSCL).............................................9-6
All list recording ..............................................................................9-6
List record pattern selection .............................................................9-7
Automatic recording...............................................................................9-8
Simple list recording (LST)..............................................................9-8
Measurement value recording (OSCL).............................................9-9
Measurement record selection........................................................9-10
Deleting list data............................................................................9-11
Recorder error................................................................................9-11
Chapter 10: Setup
How to setup........................................................................................10-2
Settings in Setting Mode................................................................10-2
Settings in Utility Mode ................................................................10-2
Setting Mode........................................................................................10-4
Setting procedure...........................................................................10-4
Setting method for each item .........................................................10-5
Utility Mode ......................................................................................10-11
Setting procedure.........................................................................10-11
Setting method for each item .......................................................10-12
Chapter 11: Internal Battery
About the internal battery ....................................................................11-2
When using the internal battery for the first time.................................11-2
Battery indicator and battery icon.........................................................11-2
Charging types and battery indicator display ........................................11-2
Battery icon display ..............................................................................11-3
Battery low...........................................................................................11-3
Battery not mounted ............................................................................11-3

Contents vii
Contents
Operating time.....................................................................................11-4
Battery and ambient temperature .........................................................11-4
Warranty..............................................................................................11-4
Appendix A
Error code table..................................................................................... A-2
System error code table................................................................... A-2
Non-Invasive Blood Pressure (NIBP)
measurement section error code list ............................................ A-4
SpO2error code table ................................................................... A-10
Body temperature error code table ................................................ A-12
Principles ............................................................................................ A-14
Non-invasive pressure measurement principles ............................. A-14
Basic principles of SpO2measurement.......................................... A-15
Principle of operation (for Masimo® model).................................. A-17
Default setting..................................................................................... A-19
Operation following interruption of the power supply.................. A-19
Maintenance ....................................................................................... A-21
Maintenance inspection and safety management........................... A-21
Managing consumables................................................................. A-21
Device maintenance...................................................................... A-22
Accessory care ............................................................................... A-23
Checking before use ............................................................................ A-24
Each day ....................................................................................... A-24
Maintenance checks ............................................................................ A-26
Before turning ON the power....................................................... A-26
After turning ON the power......................................................... A-26
Troubleshooting.................................................................................. A-27
Main unit ..................................................................................... A-27
Non-Invasive Blood Pressure Measurement (NIBP) ..................... A-27
Arterial Oxygen Saturation by pulse oximeter measurement
(SpO2)...................................................................................... A-29
Problems with E-Temp................................................................. A-30
Disposal .............................................................................................. A-31
Description................................................................................... A-31
Specifications ...................................................................................... A-32
General......................................................................................... A-32
Output terminals (optional).......................................................... A-34
Environmental conditions............................................................. A-35
Non-Invasive Blood Pressure (NIBP)............................................ A-36

Contents
viii
Contents
Pulse oximeter (models with Nellcor® SpO2) ................................ A-38
Pulse oximeter (models with Masimo® SpO2) ............................... A-40
E-Temp ........................................................................................ A-42
FCC STATEMENT..................................................................... A-43
Manufacturer’s declaration............................................................ A-44

Cardiac Science 5300/5350 Vital Signs Monitor 70-00582-01 A 1-1
1Safety
Contents
◆Intended use 1-2
◆Vital signs monitor orderable part number legend 1-3
◆Warnings and cautions 1-5
◆Symbols and labels 1-13
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
[phone] (USA)
[phone] (USA and Canada)
[e-mail]
[phone] (USA)
[phone] (USA and Canada)
[email protected]om
http://websupport.cardiacscience.com/webchat/

70-00582-01 A Cardiac Science 5300/5350 Vital Signs Monitor
1-2
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 (SpO2 via finger oximeter)
This device is intended for use by qualified healthcare personnel trained in its use.

Cardiac Science 5300/5350 Vital Signs Monitor 70-00582-01 A 1-3
Vital signs monitor orderable part number legend
Vital signs monitor orderable part number legend
Vital Signs Monitor
Models: 5300, 5350, 5500
All parts will have a part number with a maximum of 10 digits following this scheme:
For Example:
◆V530BNTP01—Cardiac Science 5300 Vital Signs Monitor Standard with NIBP,
Nellcor Sp02, Temperature, Printer
◆V535B0TP01—Cardiac Science 5350 Vital Signs Monitor, Alarms, Intervals, NIBP,
Temperature, Printer
◆V550BMTP01—Cardiac Science 5500 Vital Signs Monitor, ECG, Masimo,
Temperature, Printer
1Family V — Vital Signs
2Model
530—Standard
535—with Alarms, Intervals
550—with ECG
3NIBP 0—None
B—NIBP
4SpO2
0—None
N—Nellcor SpO2
M—Masimo SpO2
R—Refurbished
5Temperature 0—None
T—Temperature
6Printer 0—None
P—Printer
7Future 01—Reserved for future use
V 530 B N T P 01
123
457
6

70-00582-01 A Cardiac Science 5300/5350 Vital Signs Monitor
1-4
Safety
Part
Number NIBP
SpO2
Temp Recorder Alarm IntervalNellcor® Masimo®
Cardiac Science 5350
V535BNTP01 X X X X X X
V535BMTP01 X X X X X X
V535BN0P01 X X X X X
V535BM0P01 X X X X X
V535B0TP01 X X X X X
V535B00P01 X X X X
V535BNT001 X X X X X
V535BMT001 X X X X X
V535BN0001 X X X X
V535BM0001 X X X X
V535B0T001 X X X X
V535B00001 X X X
Cardiac Science 5300
V530BNTP01 X X X X
V530BMTP01 X X X X
V530BN0P01 X X X
V530BM0P01 X X X
V530B0TP01 X X X
V530B00P01 X X
V530BNT001 X X X
V530BMT001 X X X
V530BN0001 X X
V530BM0001 X X
V530B0T001 X X
V530B00001 X

Cardiac Science 5300/5350 Vital Signs Monitor 70-00582-01 A 1-5
Warnings and cautions
Warnings and cautions
Safety alert descriptions
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.
!
WARNING!
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.
General warnings and cautions
!
WARNING!
Only properly trained medical personnel should use this device. Do not allow patients to
operate this device.
!
WARNING!
If the monitor cannot take a measurement or the measurement readings seem dubious,
check the condition of the patient first.
!
WARNING!
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.

70-00582-01 A Cardiac Science 5300/5350 Vital Signs Monitor
1-6
Safety
!
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.
!
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 60601-1-
2:2001), 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.

Cardiac Science 5300/5350 Vital Signs Monitor 70-00582-01 A 1-7
Warnings and cautions
Installation
!
DANGER!
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.
!
WARNING!
Use with the specified AC voltage and frequency.
!
WARNING!
Use a grounded AC outlet for the power supply and ground this device.
!
WARNING!
Do not connect a grounding wire to a gas pipe or water pipe.
!
WARNING!
For accessories mounted on the patient, optional parts, and consumables, use only those
supplied or specified by Cardiac Science.
!
WARNING!
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.

70-00582-01 A Cardiac Science 5300/5350 Vital Signs Monitor
1-8
Safety
!
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
!
WARNING!
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
!
WARNING!
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 hyper-
coagulate, 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.

Cardiac Science 5300/5350 Vital Signs Monitor 70-00582-01 A 1-9
Warnings and cautions
!
Caution
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.
SpO2
!
Caution
Do not look at the light from the SpO2sensor for a long period of time.
!
Caution
If the adhesive tape irritates the patient's skin, stop using it.
!
Caution
Do not fasten sensors with tape. This can cause hemostasis or edema.
!
Caution
•The SpO2sensor should be checked every two to three hours, and the sensor
location changed when abnormality is observed. For a patient with extremity or
circulatory obstruction, failure to change the sensor location can cause a rash low-
temperature burn, or other problems.
•SpO2sensors (single-patient use only) can be reused only with the same patient.
•Do not insert the finger too far into the sensor. Doing so could cause injury.
!
Caution
This device has no alarm function for SpO2. (5300 only)
!
Caution
For models with Masimo® SpO2
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.

70-00582-01 A Cardiac Science 5300/5350 Vital Signs Monitor
1-10
Safety
Temperature
!
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.

Cardiac Science 5300/5350 Vital Signs Monitor 70-00582-01 A 1-11
Warnings and cautions
Internal Battery
!
DANGER!
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.