Konica Minolta Pulsox-2 Manual de usuario
MEDICAL EQUIPMENT
(
70SA
)
This indicates text consisting of a warning or precaution relating to safety.
Please read the text carefully and use the equipment safely.
For North America
UL, C_ UL:
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2
No.601.1
Safety Symbols
Warnings and precautions noted in this manual are indicated by the following mark-
ings, designed to prevent accidents caused by erroneous handling of the equipment.
Authorized Standards
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.
For Europe
CE (Medical Device Directive):
This instrument complies with EN60601-1, EN60601-1-2, EN14971,
EN13485.
1
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.
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 KONICA MINOLTA SENS-
ING. 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 at-
tached 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 doc-
tor. 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 disassemble or modify the instrument. Doing so may cause a fire or elec-
tric shock.
Do not use wet batteries. Do not use instrument if the battery compartment con-
tains water. Doing so may cause explosion or heat generation, resulting in fire or
injury.
2
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 satu-
ration (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 instru-
ment.
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 (% SpO2) of arterial blood and the pulse rate.
• 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 addi-
tion, it is easily transported by both doctors and nurses for house calls
or home-care patients.
• Battery-operated
The PULSOX-2 is operated by two AAA-size alkaline batteries.
3
2. NAMES OF PARTS
■ Main unit
Battery cover: Open or close this cover when replacing the
batteries with new ones.
Battery cover lock: It is used to lock the battery cover.
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 instru-
ment.
Display: Displays measured value, pulse level meter
and error messages.
Thumb rest
Battery cover Display
Battery cover lock
Strap eyelet
Finger holder
4
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 water-
proof, 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 ac-
curate.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 oxi-
meters, 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 re-
sult in measurement error.
• This instrument may interfere with magnetic resonance imaging (MRI) proce-
dure.
• 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.
5
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 protec-
tion 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.
6
4. OPERATING METHOD
Preparations
(1) Installing Batteries
(Two AAA-size batteries are required.)
1. Push the battery cover, and unlock
the battery cover lock.
2. Open the battery cover.
3. Insert two AAA-size batteries into
the battery chamber.
4. Close the battery cover and hold it
with a finger.
1
23
4
7
5. Close the battery cover lock until it
clicks.
• The batteries will last approxi-
mately 80 hours.
• The battery mark will begin to
blink when the battery power is
low.
Notes on Use
• Battery replacement is the Only User Serviceable item.
• When replacing the batteries with new ones, do not mix battery types or
ages.
• If the instrument will not be used for a long period of time, remove the
batteries from the battery chamber. Also remove the batteries as soon
as possible if they are dead.
(2) Installing the Neck Strap
By attaching the neck strap to the instrument, the instrument can
be hung from the neck.
1. Pass the neck strap through the
strap eyelet as shown in the figure.
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8
Measurements
Measurements must be taken with the index finger placed in the
finger holder. This instrument must be held tightly. Put the thumb
only on the thumb rest. You must not put the thumb on other posi-
tions. Don't take the pressure which is unnecessary for the forefin-
ger. Those are important for the accurate measurement.
1. Open the finger holder.
2. Insert the index finger and re-
lease the finger holder.
• Opening the finger holder will
start measurement automati-
cally.
The finger should be put on the po-
sition shown in the figure below.
Measurement
display
Sensor
Light Source
Proper attachment Finger is not sufficiently
inserted.
Finger is inserted too far.
Measurement cannot be taken.
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