Intended Use - Henry Schein 900-8275 Manuel D'utilisation

ENGLISH
Warnings!
Before putting the system into operation, verify that the equipment, connecting cables and accessories are
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in correct working order and operating condition.
To avoid explosion hazard, do not use the pulse oximeter in an explosive atmosphere or in the presence
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of flammable anesthetics, vapors or liquids.
Do not use the pulse oximeter in an MRI or CT environment.
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The pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction
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with other methods of assessing clinical signs and symptoms.
The surface of the device can be wiped with alcohol gently. Do not allow to come into contact with
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corrosive gases and liquids such as strong acid and alkali substance.
Do not open the equipment housing; electric shock hazard may occur. All servicing and future upgrades
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must be carried out by personnel trained and authorized by our company only.
Prolonged use of the probe/sensor or patient's condition may require changing the sensor site periodically.
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Change the sensor site and check skin integrity, circulatory status, and correct alignment at least every 4
hours. Prolonged use may cause blisters, skin deterioration, and discomfort.
Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death, so pay close
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attention to the sensor and inspect frequently.
Do not rely only on the audible alarm system for patient monitoring. Adjustment of alarm volume to off may
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result in anxiety to the patient. Remember that alarm settings should be customized according to different
patient situations.
When using the equipment with electrosurgical units (ESU), make sure the patient is safe.
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Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could
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result. – NOT SURE I Understand this statements
Single-use accessories should not be reused.
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To avoid inadvertent disconnection, ensure all cables and wires are in a secure and safe position. Wrap
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and secure excess cabling to avoid risk of entanglement or hazard to patients or personnel.
Cautions
Autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid may cause inaccurate readings.
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To ensure patient safety, use only parts and accessories specified in this manual.
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The operator must read and understand all the information in this manual before using the device.
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Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For
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this reason make sure that all external devices operated in the vicinity of the equipment comply with the
relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic radiation.
Unplug the sensor from the pulse oximeter before cleaning or disinfecting it.
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If liquid is accidentally spilled on the unit, clean and dry thoroughly before re-use.
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Do not use SpO
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measurement accuracy.
The disposal of the equipment, as well as its accessories, must be in compliance with the
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guidelines/directives regulating the disposal of such products.
Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration
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or other mechanical force.
Alarm must be set up according to different requirements of individual patients. Make sure that alarm
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sound can be activated when alarm function begins to work.
Notes
The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from
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software errors is therefore minimized.
SpO measurements may be influenced by high ambient light, especially sunlight. Shield the sensor area
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if necessary.
Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and
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fluorescein, may influence the accuracy of the SpO
Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic
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vascular resistance, may cause a failure to determine accurate pulse rate and SpO
Remove fingernail polish or artificial fingernails before applying SpO
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fingernails may cause inaccurate SpO
Optical crosstalk (interference) can occur when two or more sensors are located in adjoining areas. It can
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be eliminated by covering each site with opaque material. Optical crosstalk may adversely affect the
accuracy of the SpO
Obstructions or dirt on the sensor's red light or detector may cause a sensor failure. Make sure there are
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no obstructions and the sensor is clean.
For routine equipment maintenance, please refer to the service procedures at the associated section as
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indicated in the manual.
Dispose of the device or its accessories at end of life in accordance with the local ordinances/regulations
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or directives, otherwise, discarding them as you like may cause pollution to the environment.
It is not recommended to take measurements during battery charging.
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Federal Law restricts this device to sale by or on the order of a physician.
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As to the other concerns for attention, please carefully look through the specific chapter in this instruction.
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1.3 Intended Use

The Henry Schein handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional
pulse oxygen saturation (SpO
home care.
and NIBP measurement on the same arm at the same time. This could potentially affect
readings.
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readings.
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) and pulse rate (PR) of single adult and pediatric patients in hospitals and
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reading.
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sensors. Fingernail polish or artificial
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3
readings.
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