Section 1 Safety
1.1 Instructions for the Safe Operation and Use
• Do not attempt to service the Suresense Pulse Oximeter. Only qualified service personnel should
attempt any needed internal servicing.
• Prolonged use or the patient’s condition may require changing the sensor site periodically. Change
sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.
• SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the
sensor area (with a surgical towel for example) if necessary.
• The following reasons may cause interference to the testing accuracy of the Suresense Pulse
Oximeter.
o High-frequency electrosurgical equipment.
o Placement of a sensor on an extremity with a blood pressure cuff arterial catheter,
or intravascular line.
o The patient has hypotension severe vasoconstriction severe anemia or hypothermia.
o The patient is in cardiac arrest or is in shock.
• Fingernail polish or false fingernails may cause inaccurate SpO2 readings.
• The device should not be used for at least 10 minutes when moving from non-working
temperatures to normal temperatures.
• The device is non-sterile and not intended to be sterilised.
1.2 Warnings
Warning
: Although this device conforms to the intent of the standard EN 60601-1-2 in relation to
electromagnetic compatibility, electrical equipment may produce interference. If interference is suspected,
move equipment away from sensitive device or contact us. Portable and mobile RF communication
equipment can affect this instrument’s normal operation.
Warning:
EXPLOSIVE HAZARD – Do not use the Suresense Pulse Oximeter in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
Warning:
Do not dispose of batteries in fire as this may cause them to explode.
Warning:
Do not attempt to recharge normal dry-cell batteries – they may leak and may cause a fire or even
explode.
Warning:
Do not use the Suresense Pulse Oximeter in an MRI or CT environment.
Warning:
Do not modify this equipment without authorisation from the manufacturer.
Warning:
If this equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of equipment.
Caution:
Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and
extremes of temperature and humidity.
Caution:
Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the
equipment immediately after moving it from a cold environment to a warm, humid location.
Caution:
Never use sharp or pointed object to operate the front-panel switches.
Caution:
The batteries must be taken out from the battery compartment if the device will not be used for a
long time.
Caution:
The device shall only be used if the battery cover is closed.
Caution:
The batteries must be properly disposed according to the local regulation after their use.
Caution:
The device should keep away from the children, pets and pests to avoid swallowing.
1.3 Definitions and symbols
