ZONDAN A3 Instructions Pour L'utilisateur

(EN) MANUAL - PULSE OXIMETER A3 -
INSTRUCTIONS TO USER
IMPORTANT INFORMATION! RETAIN FOR
FUTURE USE!
Read the instruction manual carefully before using this device,
especially the safety instructions and keep the instruction manual for
future use. Should you give this device to another person, it is vital that
you also pass on these instructions for use.
Failure to follow these instructions can cause damage to the device and
personal injury. The manufacturer is not responsible for the safety, reliability
and performance issues and any monitoring abnormality, personal injury
and damage to the device due to user's negligence of the operation
instructions. Intended use: spot checking of oxygen saturation, SpO2 and
pulse rate of an adult. Not for continuous monitoring.
WARNING:
• An uncomfortable or painful feeling may appear if using the device
ceaselessly, especially for the microcirculation barrier patients. It
is recommended that the sensor should not be applied to the same
finger for over 2 hours.
• The device cannot be clipped on the edema and tender tissue.
• The infrared light emitted from the device is harmful to the eyes.
The user cannot stare into the light.
• Users fingernail cannot be too long and must be clean.
• Fingernail polish or acrylic nails may result in inaccurate readings.
1. SAFETY
1.1 INSTRUCTIONS FOR SAFE OPERATIONS
• Check the device and all accessories periodically to make sure that
there is no visible damage that may affect user's safety and monitoring
performance about cables and transducers. It is recommended that the
device should be inspected at least once a week. When there is obvious
damage, stop using the device.
• Necessary maintenance must be performed by qualified service
engineers only. Users are not permitted to maintain it by themselves.
• The device cannot be used together with devices not specified in the
user manual. Only the accessory supplied with this device can be used.
• The equipment is calibrated to display functional oxygen saturation.
1.2 WARNINGS
• Explosive hazard - DO NOT use the device in environments with
inflammable gas such as some ignitable anesthetic agents.
• DO NOT use the device in an MRI or CT environment.
• DO NOT use this device when the user is allergic to rubber.
• The disposal of scrap instrument, accessories and packings (including
battery, plastic bags, foams and paper boxes) should follow the local
laws and regulations.
• Please check the packing before use to make sure the device and
accessories are totally in accordance with the packing list, or else the
device may have the possibility of working abnormally.
• Please do not measure this device with function test paper for the
device's related information.
1.3 ATTENTIONS
• Keep the device away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
• If the device gets wet, please stop operating.
• When it is carried from cold environment to warm or humid environment,
please do not use it immediately.
• DO NOT operate keys on front panel with sharp materials.
• High temperature or high-pressure steam disinfection of the device
is not permitted. Refer to the user manual in the relative chapter for
instructions of cleaning and disinfection.
• Do not immerge the device into liquid. When it needs cleaning, use a
soft cloth, moistened with isopropyl alcohol. Do not spray any liquid on
the device.
• When the fingers are too thin or too cold, it will affect the normal
measure of the users SpO2 and pulse rate, please clip a finger such as
the thumb or middle finger deeply enough into the probe.
• Do not use the device on infants or neonatal patients.
• The device is suitable for children above 14 years old and adults.
• The device may not work for all users. If you are unable to achieve stable
readings, discontinue use.
• The update period of data is less than 5 seconds, which is changeable
according to different individual pulse rate.
• The waveform is normalized. Please read the measured value when
the waveform on screen is equably and steady going, here this
measured value is optimal value and the waveform at the moment is the
standard one.
• If some abnormal conditions appear on the screen during test process,
pull out the finger and reinsert to restore normal use.
• The device has normal useful life for three years since the first electrified
use.
• Batteries must be removed if the device will be stored for more than one
month, or else batteries may leak.
• A flexible circuit connects the two parts of the device. Do not twist or pull
on the connection.
2. OVERVIEW
2.1 CLASSIFICATION
Class II B, (MDD93/42/EEC IX Rule 10)
2.2 FEATURES
• The total weight is +/- 50 g including batteries.
• Power consumption of the product is low. With two AAA batteries the
device can operate continuously for 50 hours.
• The device will enter standby mode when no signal is in the product
within 8 seconds.
• Display direction can be changed, easy to view.
2.3 MAJOR APPLICATIONS AND SCOPE OF APPLICATION
The device can be used to measure human hemoglobin saturation and pulse
rate through the finger and indicate the pulse intensity by the bar-display.
The device is not suitable for use in continuous supervision
for patients.
The problem of overrating would emerge when the patient is
suffering from toxicosis which caused by carbon monoxide, the
device is not recommended to be used under this circumstance.
2.4 ENVIRONMENT REQUIREMENTS
Storage environment
a. Temperature: -20° C ~ +55° C
b. Relative humidity: 10% ~ 93%
c. Atmospheric pressure: 22 kPa ~ 107.4 kPa
Operating environment
a. Temperature: 0° C ~ 40° C
b. Relative humidity: 15% ~ 80%
c. Atmospheric pressure: 59 kPa ~ 107.4 kPa