Minolta Pulsox-2 User Manual
Oxygen Saturation Monitor
PULSOX™-2
INSTRUCTION MANUAL
Safety Symbols
Warnings and precautions noted in this manual are indicated by the
following markings, designed to prevent accidents caused by erroneous
handling of the equipment.
This indicates text consisting of a warning or precaution relating to
safety. Please read the text carefully and use the equipment safely.
This indicates an action which is prohibited.
The prohibited action should never be carried out, under any circumstances.
This indicates instructions concerning an action.
Always follow the instructions carefully.
This indicates an action which is prohibited.
Never disassemble the product or unit.
This symbol indicates type BF applied part.
The instrument provide a particular degree of protection against
electric shock, particularly the leakage current and reliability of the
protective earth connection with an F-TYPE APPLIED PART.
F-TYPE APPLIED PART indicates applied part isolated from all other
parts of the instrument to such a degree that the patient leakage
current allowable in single fault condition is not exceeded when a
voltage equal to 1.1 times the highest rated mains voltage is applied
between the applied part and earth.
IPX4
This symbol indicates Splash-proof equipment.
Authorized Standards
For North America
UL, C_ UL:
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONL Y IN ACCORDANCE WITH UL 2601-1, CAN/
CSA C22.2 No.601.1
MEDICAL EQUIPMENT (70SA
)
For Europe
CE (Medical Device Directive):
This instrument complies with EN60601-1, EN60601-1-2,
EN1441, EN46001.
SAFETY PRECAUTIONS
To ensure correct use of this instrument, read the following points
carefully and adhere to them. After you have read this manual, keep
it in a safe place where it can be referred to anytime a question
arises.
WARNING
(Failure to adhere to the following points may result in death or
serious injury.)
Do not use the instrument in places where flammable or combustible
gases (anesthetic gas etc.) are present. Doing so may cause a fire.
Do not put the batteries on a fire, short-circuit them, heat them or
disassemble them. Doing so may cause explosion or heat generation,
resulting in fire or injury.
This device is designed to measure the oxygen saturation level (SpO2)
and the pulse rate. It should not be used as a warning device to detect
cessation of breathing or irregular breathing during sleep.
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CAUTION
(Failure to adhere to the following points may result in injury or
damage to the instrument or other property.)
Do not use batteries other than those specified by MINOLTA. When
installing batteries in the instrument, make sure that they are correctly
oriented according to the (+) and (–) marks. For a model which use
more than one battery, do not mix new and old batteries, or mix batteries
of different types. Failure to adhere to these instructions may cause
explosion of the batteries or leakage of electrolyte, resulting in fire,
injury or corrosion.
Do not place the instrument on an unstable or sloping surface. Doing
so may result in its dropping or overturning, causing injury. Take care
not to drop the instrument when carrying it.
Do not operate the instrument for long periods of time with a finger
holder attached to a patient. Low-temperature burn, redness or rash
may result. If you feel pain or itchiness, stop use of the instrument
immediately and consult a doctor. A doctor should also be consulted
before using the instrument on infants, those with peripheral blood
circulation problems or those with sensitive skins.
If alkali fluid from the battery comes in contact with eyes, skin, or
clothing, immediately wash the affected area and see a physician for
treatment.
Do not use wet batteries. do not use instrument if the battery
compartment contains water . Doing so may cause explosion or heat
generation, resulting in fire or injury.
Do not disassemble or modify the instrument. Doing so may cause a
fire or electric shock
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1. BEFORE OPERATION
Safety Notes
CAUTION: Federal law restricts this device to sale by or on the
order of a physician.
The PULSOX-2 is a medical instrument, so instructions given by a
doctor must be adhered to.
The instrument is designed for measurement of the oxygen
saturation (SpO2) of arterial blood and the pulse rate. Do not use
it for any other purposes, such as warning of sleep apnea and
breathing abnormalities.
Package Contents
Make sure that all the following items are supplied with the instrument.
1 PULSOX-2 main unit (×1)
2 Neck strap NS-M (×1)
3 AAA-size alkaline battery (×2)
Main Features
This pulse type oximeter emits light to the user’s finger to measure the
oxygen saturation (SpO
• Compact, lightweight and portable
The light weight, compactness, and portability of the PULSOX-2 allows it
to be used for inspection of both outpatients and inpatients. In addition, it
is easily transported by both doctors and nurses for house calls or homecare patients.
2 %) of arterial blood and the pulse rate.
• Battery-operated
The PULSOX-2 is operated by two AAA-size alkaline batteries.
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2. NAMES OF PARTS
■ Main unit
Battery cover lock
Battery cover
Finger holder
Strap eyelet
Display
Thumb rest
Battery cover: Open or close this cover when replacing the
batteries with new ones.
Battery cover: It is used to lock the battery cover.
lock
Strap eyelet: Attach the neck strap to this hook.
Finger holder: Holds finger when inserted for measurement.
A light source is located in the upper side, and a
sensor in the lower side.
Thumb rest: Put the thumb here when you hold this instrument.
Display: Displays measured value, pulse level meter and error
messages
.
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3. NOTES ON USE
• This instrument should be used in areas with an ambient temperature of 0 to
40°C (32 to 104°F) and a relative humidity of 30 to 95%, with no condensation.
• This is a precision instrument. To avoid the possibility of it being damaged,
the instrument should not be dropped nor should heavy objects be placed
on top of it.
• This instrument conforms to water-seal rating of IPX4 (IEC 60529), which
ensures that the instrument will show no adverse damage even if exposed
to water splashing from any direction. However, the instrument is not waterproof, so it should never be washed with water or left immersed in water.
• When the water remains in finger holder, the measurement value is not
accurate.Turn the part of strap eyelet to the bottom, and remove the water.
• This instrument should not be used in areas subject to strong vibrations, nor
should it be subjected to physical shock. Doing so may cause breakdown.
• The finger holder is a delicate device and should not be handled roughly nor
should objects be placed on top of it.
• The accuracy of this instrument, like that of all other dual-wavelength
oximeters, can be influenced by the presence of abnormal hemoglobins such
as carboxyhemoglobin (HbCO) and methemoglobin. Tables 1 and 2 below
show the errors which may occur due to these hemoglobins. The instrument
may also be affected by cardiogreen or intravascular dyes.
• Do not use a mobile telephone when using this instrument. Doing so may
result in measurement error.
• This instrument may interfere with magnetic resonance imaging (MRI)
procedure.
• The disposal method of AAA batteries varies according to local government
regulation.
• Dispose of the battery according to the instructions given by local government
regulations or ask a specialized waste service company to dispose of it.
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This equipment has been tested and found to comply with the limits for
medical devices to the IEC 60601-1-2:2001, Medical Device Directive
93/42/EEC . These limits are designed to provide reasonable protection
against harmful interference in a typical medicitl installation. This
equipment generates, uses and can radiate radio frequency energy and,
if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to other devices, which
can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that
to which the other device's are connected.
• Consult the manufacture or field service technician for help.
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