PULSE OXIMETER
- 2 -
HCSMD400
- 2 -
Warnings!
Before use, carefully read the manual. This device is intended for use by persons trained
in professional health care. Our company will assume no warranty for using this equipment
improperly.
The pulse oximeter is to be operated by qualified personnel only.
Operation of the pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death,
so pay close attention to the sensor and inspect it often.
Do not use the pulse oximeter in an MRI or CT environment.
Although the pulse oximeter has alarms, it is not suggested for long time continuous
monitoring.
Do not use the pulse oximeter in an explosive atmosphere.
The pulse oximeter is intended only as an adjunct in patient assessment. It must be used in
conjunction with other methods of assessing clinical signs and symptoms.
Check the pulse oximeter sensor application site half an hour to determine the positioning
of the sensor and circulation and skin sensitivity of the patient.
When link this equipment to other peripherals, make sure you are sophisticated operator
to handle this device. Any peripherals should be in the light of protocol of IEC 60601-1. Any
input/output device should be following the protocol of IEC 60601-1.
Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the
device in liquid. The device is not intended for sterilization.
Follow local ordinances and recycling instructions regarding disposal or recycling of the
device and device components, including batteries.
This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility for
medical electrical equipment and/or systems. However, because of the proliferation of radio-
frequency 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.
Portable and mobile RF communications equipment can affect medical electrical equipment.
You should operate the equipment according to the EMC information provided in the
accompanying documents.
This equipment should not be used adjacent to or stacked with other equipment.
This equipment is not intended for use during patient transport outside the healthcare
facility
When connecting this device to other peripherals, make sure that you are qualified to
operate this device. Any peripheral must be certified according to the protocol of IEC 60601-
1. Any input/output device should follow the protocol of IEC 60601-1.
Rx only: “Caution: Federal law restricts this device to sale by or on the order of a
physician.”
Cautions:
The handheld pulse oximeter must be able to measure the pulse properly to obtain an
accurate SpO
2
measurement. Verify that nothing is hindering the pulse measurement before
relying on the SpO
2
measurement.
Worn-out data cables may also cause inaccurate data, so if the data is used as a reference
