Lode BV
Excalibur Sport
78
Warnings
−
Use only pulse oximeter sensors supplied by Lode B.V.. These sensors are
manufactured to meet the accuracy specifications for pulse oximeter hardware. Using
other manufacturers’ sensors can result in improper pulse oximeter performance.
−
Explosion Hazard: Do not use the SpO
2
option in an explosive atmosphere or in the
presence of flammable anesthetics or gases.
−
Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that
no blood flow restrictors (e.g., blood pressure cuff) hinder pulse measurements.
−
As with
all medical equipment, carefully route cables and connections to reduce the
possibility of
entanglement or strangulation.
−
This device does not meet defibrillation-proof requirement per IEC 60601-1: 1990,
clause 17.h.
−
Operation of this device below the minimum amplitude of 0.5% modulation may
cause inaccurate results.
Cautions
−
The accuracy of the SpO
2
measurement may be affected if the total cable length
(including extension cables) is greater than 3 meters.
−
This pulse oximetry system is designed to determine the percentage of arterial oxygen
saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin,
such as methemoglobin, might affect the accuracy of the measurement.
−
The SpO
2
option has motion tolerant software that minimizes the likelihood of motion
artifact being misinterpreted as good pulse quality. In some circumstances, however,
the SpO
2
option may still interpret motion as good pulse quality.
−
Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor
alignment and skin integrity. Patient sensitivity may vary due to medical status or skin
condition. Discontinue use of adhesive tape strips if the patient exhibits an allergic
reaction to the adhesive material.
−
This module complies with International Standard EN 60601-1-2:2001 for
electromagnetic compatibility for medical electrical equipment and/or systems. This
standard is designed to provide reasonable protection against harmful interference in a
typical medical installation. However, because of the proliferation of radiofrequency
transmitting equipment and other sources of electrical noise in healthcare and other
environments, it is possible that high levels of such interference due to close proximity
or strength of a source might disrupt the performance of this device. Medical electrical
equipment needs special precautions regarding EMC, and all equipment must be
installed and put into service according to the EMC information specified in this
manual.
−
Portable and mobile RF communications equipment can affect medical electrical
equipment.
For more information about required safety and regulatory requirements for medical devices,
refer to EN865 and IEC 60601-1.
Summary of Contents for 925900
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