Riester RVS-100 Gebrauchsanweisung Seite 80

Appendix F RVS-100
with Masimo SpO2
5.2.5 Setting SpO2
Select [SETTING] > [ADVANCED] > [PARAMETERS] > [SpO2] >
[Default response] to choose the response to be [Normal: 16 se-
conds] or [Fast: 4 seconds]. (Not applicable to Masimo)
5.2.7 General statements, warnings, cautions, and notes for Ma-
simo SpO2
General:
The pulse co-oximeter is to be operated by, or under the supervisi-
on of, qualified personnel only. The manual, accessories, directions
for use, all precautionary information, and specifications should be
read before use.
Warnings:
As with all medical equipment, carefully route patient cabling to re-
duce the possibility of patient entanglement or strangulation.
Do not place the pulse co-oximeter or accessories in any position
that might cause it to fall on the patient.
Do not start or operate the pulse co-oximeter unless the setup was
verified to be correct.
Do not use the pulse co-oximeter during magnetic resonance ima-
ging (MRI) or in an MRI environment.
Do not use the pulse co-oximeter if it appears or is suspected to
be damaged.
Explosion hazard: Do not use the pulse co-oximeter in the presence
of flammable anesthetics or other flammable substance in com-
bination with air, oxygen-enriched environments, or nitrous oxide.
To ensure safety, avoid stacking multiple devices or placing anything
on the device during operation.
To protect against injury, follow the directions below: Avoid placing
the device on surfaces with visible liquid spills.
Do not soak or immerse the device in liquids.
Do not attempt to sterilize the device.
Use cleaning solutions only as instructed in this operator's manual.
Do not attempt to clean the device while monitoring a patient.
To protect from electric shock, always remove the sensor and com-
pletely disconnect the pulse co-oximeter before bathing the patient.
If any measurement seems questionable, first check the patient's
vital signs by alternate means and then check the pulse co-oxime-
ter for proper functioning.
Inaccurate respiration rate measurements may be caused by:
Improper sensor application
Low arterial perfusion
Motion artifact
Low arterial oxygen saturation
Excessive ambient or environmental noise
Inaccurate SpCO and SpMet readings can be caused by:
Improper sensor application, Intravascular dyes such as indocya-
nine green or me¬thylene blue, Abnormal hemoglobin levels, Low
arterial perfusion, Low arterial oxygen saturation levels including
altitude induced hypoxemia, Elevated total bilirubin levels, Motion
artifact
Inaccurate SpHb and SpOC readings may be caused by:
Improper sensor application, Intravascular dyes such as indocyani-
ne green or me¬thylene blue, Externally applied coloring and tex-
ture such as nail polish, acrylic nails, glitter, etc., Elevated PaO2
levels, Elevated levels of bilirubin, Low arterial perfusion
Motion artifact, Low arterial oxygen saturation levels, Elevated car-
boxyhemoglobin levels, Elevated methemoglobin levels, Hemoglo-
binopathies and synthesis disorders such as thalassemias, Hb s, Hb
c, sickle cell, etc., Vasospastic disease such as Raynaud's, Elevated
altitude, Peripheral vascular disease, Liver disease, EMI radiation
interference
Inaccurate SpO2 readings may be caused by: Improper sensor ap-
plication and placement
Elevated levels of COHb or MetHb: High levels of COHb or MetHb
may occur with a seemingly normal SpO2.
When elevated levels of COHb or MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
Elevated levels of bilirubin
Elevated levels of dyshemoglobin
Vasospastic disease, such as Raynaud's, and periphe¬ral vascular
disease
Hemoglobinopathies and synthesis disorders such as thalasse-
mias, Hb s, Hb c, sickle cell, etc., Hypocapnic or hypercapnic con-
80
ditions, Severe anemia, Very low arterial perfusion, Extreme motion
artifact, Abnormal venous pulsation or venous constriction, Severe
vasoconstriction or hypothermia, Arterial catheters and intra-aortic
balloon, Intravascular dyes, such as indocyanine green or methyle-
ne blue, Externally applied coloring and texture, such as nail polish,
acrylic nails, glitter, etc., Birthmark(s), tattoos, skin discolorations,
moisture on skin, deformed or abnormal fingers. etc., Skin color
disorders
Interfering Substances: Dyes or any substance containing dyes that
change usual blood pigmentation may cause erroneous readings.
The pulse co-oximeter should not be used as the sole basis for di-
agnosis or therapy decisions. It must be used in conjunction with
clinical signs and symptoms.
The pulse co-oximeter is not an apnea monitor.
The pulse co-oximeter may be used during defibrillation, but
this may affect the accuracy or availability of the parameters and
measurements.
The pulse co-oximeter may be used during electrocautery, but
this may affect the accuracy or availability of the parameters and
measurements.
The pulse co-oximeter should not be used for arrhythmia analysis.
SpCO readings may not be provided if there are low arterial satura-
tion levels or elevated methemoglobin levels.*
SpO2, SpCO*, SpMet*, and SpHb* are empirically calibrated in heal-
thy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
Do not adjust, repair, open, disassemble, or modify the pulse co-
oximeter or accessories. Injury to personnel or equipment damage
could occur. Return the pulse co-oxi¬meter for servicing if neces-
sary.
Cautions:
Do not place the pulse co-oximeter where the controls can be chan-
ged by the patient.
Electrical shock and flammability hazard: Before cleaning, always
turn off the device and disconnect from any power source.
When patients are undergoing photodynamic therapy, they may be
sensitive to light sources. Pulse oximetry may be used only under
careful clinical supervision for short time periods to minimize inter-
ference with photodynamic therapy.
Do not place the pulse co-oximeter on electrical equip¬ment that
may affect the device, preventing it from working properly.
If SpO2 values indicate hypoxemia, a laboratory blood sample
should be taken to confirm the patient's condition.
If the Low Perfusion message is frequently displayed, find a better
perfused monitoring site. In the interim, assess the patient and, if
indicated, verify oxygenation status through other means.
Change the application site or replace the sensor and/or patient
cable when a "Replace sensor" and/or "Replace patient cable",
or a persistent poor signal quality message (such as "Low SIQ") is
displayed on the host monitor. These messages may indicate that
patient monitoring time is exhausted on the patient cable or sensor.
• If using pulse oximetry during full body irradiation, keep the sen-
sor out of the radiation field. If the sensor is exposed to the radi-
ation, the reading might be inaccurate or the device might read
zero for the duration of the active irradiation period.
• The device must be configured to match your local power line
frequency to allow for the cancelation of noise introduced by flu-
orescent lights and other sources.
• To ensure that alarm limits are appropriate for the patient being
monitored, check the limits each time the pulse cooximeter is
used.
• Variation in hemoglobin measurements may be profound and
may be affected by sampling technique as well as the patient's
physiological conditions. Any results exhibiting inconsistency
with the patient's clinical status should be repeated and/or sup-
plemented with additional test data. Blood samples should be
analyzed by laboratory devices prior to clinical decision making
to completely understand the patient's condition.
• Do not submerge the pulse co-oximeter in any cleaning solution
or attempt to sterilize by autoclave, irradiation, steam, gas, ethy-
lene oxide or any other method. This will seriously damage the
pulse co-oximeter.
• Electrical Shock Hazard: Carry out periodic tests to verify that
leakage currents of patient-applied circuits and the system are
within acceptable limits as specified by the applicable safety
standards. The summation of leakage currents must be checked
and in compliance with IEC 60601-1 and UL60601-1. The system
leakage current must be checked when connecting external