Orantech SpO2 User manual

User Manual
Reusable SpO2 Sensors
The dierence you can sense

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Intended Use & Indications for Use
The SpOsensors are intended for continuous noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin
(SpO) and pulse rate (PR). These compatible replacement sensors
are intended for use with major pulse oximeter brands. The SpO
sensors are designed to match the specications of the original
equipment manufacturer, therefore conrm that the appropriate
sensor model numbers are being used with the correct pulse
oximeter technology.
The sensors are available for the following patient sizes:
• Adult (weight greater than 40 kg)
• Pediatric (10-50 kg weight)
• Infant (3-20 kg weight)
• Neonate (weight less than 3 kg)
Principle of Operation
The sensors must be connected to its corresponding monitor.
Blood oxygenation is measured by detecting the infrared and red
light absorption characteristics of deoxygenated hemoglobin and
oxygenated hemoglobin, which consists of a probe attached to
the patient. The sensor is connected to a data acquisition system
which is used to calculate and display oxygen saturation levels and

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heart rate conditions.
Installation
• Connect the SpOsensor to the oximeter’s adapter cable (or
directly into the monitor).
• Turn the oximeter on and verify proper operation.
• Select the sensor site on the patient. The preferred sensor sites
are the index nger for adult and children, the great toe for
infants, and on the foot below the toes for neonate.
• Place the sensor on the patient.
• Position the emitter and detector directly opposite each other.
• Visually monitor the sensor site to ensure that over time there is
no harm to the patient’s skin.
Caution
• The sensor and its cable must be cleaned before each patient
use.
• Place the sensor on the index nger ensuring the nger is fully
inserted and the tip of the nger rests against the nger stop
inside the sensor.
• Possible alternate sites are small-sized thumb, middle and ring
ngers as well as the little nger or the big toe.

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• Ensure the ngernail is located under the nger stop on the
SpOsensor clamp.
• The sensor must not be located on the same arm as the blood
pressure cu, arterial catheter or intravascular line.
• Remove all nail polish as this can aect accuracy.
• Do not use the sensor inside or near an MRI.
• Avoid intense light sources near the sensor.
• For long-term use, the measurement site must be checked and
changed every 2-4 hours in order to guarantee the integrity of
the patient’s skin.
• In restless patients (excessive motion) use the soft tip, wrap or
multi-site sensor to help secure the sensor to the patient.
Equipment
• Connect the sensor adapter cable to the appropriate equipment
(or pulse oximeter).
• Turn on the equipment and check correct operation by
consulting the monitor’s operation instructions.
• To ensure proper monitor operations, connect and disconnect
the sensor cable from the monitor cable. The correct, safe use of
the sensor and its connecting cable requires systematic checks
to be carried out at least once or more per month depending on
the frequency of use, as well as disinfecting the cable.

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• Do a visual check (appearance of insulators, connector contact
pins, etc.).
• Verify the mechanical integrity of the connectors.
• Do not use and discard any sensor that appears to have any
mechanical or electrical aws.
Performance, Reliability, Safety,
Compatibility & Mechanical Integrity
• Performance and Reliability
This SpOsensor with its compatible pulse oximeter has been
validated and tested for compliance with ISO 80601-2-61.
Comparative value measurement in % saturation:
SpOrange (70%-100%) -Accuracy ±3%
SpOrange (<70%) -Not specied
Pulse rate range: 35-240 bpm -Accuracy ±2 bpm
Low perfusion: SpOrange (70%-100%) -Accuracy ±3%
Pulse rate range: 35-240 bpm -Accuracy ±3 bpm
• Peak Wavelength and Maximum Output Power:

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LED Type Red Peak
Wavelength
Red Maximum
Output Power
IR Peak
Wavelength
IR Maximum
Output Power
2-Leads 663 nm 1.2 mW 890 nm 1.0 mW
3-Leads 661 nm 1.2 mW 940 nm 1.2 mW
4-Leads 660 nm 1.2 mW 905/940 nm 1.0 mW
• Safety
Degree of protection from electric shocks: type BF
Classication is in accordance with MDD 93/42/EEC: Class IIb
Degree of protection against the ingress of water: IPX2
• Compatibility
In order to ensure compatibility and claimed accuracy of the
devices, the SpOsensor should only be used with the specied
equipment for which they have been designed and labeled for
use.
• Mechanical Integrity
This sensor is designed to be extremely durable. We use only the
highest quality materials to ensure the sensors stand up to the
demanding hospital environment. The solid connectors are tted
with exible sleeves to minimize the risk of cable breakage. They

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have no accessible metallic parts.
Cleaning & Disinfecting
Clean the sensor and its connecting cable with warm soapy water
or 70% isopropyl alcohol using a soft, moistened cloth. Carefully
avoid damaging the surface of the visual indicator and the
detector. Allow the sensor and the cable to dry thoroughly before
use. Do not use any abrasive agents or chemical product except
70% isopropyl alcohol.
Do not irradiate, autoclave, soak or immerse the sensor in any kind
of solution. Keep the sensor clean and dry.
The average life expectancy of a SpOsensor is more than a
year under the conditions of use dened in these operating
instructions.
Storage & Handling
When not in use, sensors should be loosely coiled and stored at
room temperature. Don’t wrap sensors around equipment cases to
avoid damaging internal wires.
Operating Conditions
• Ambient temperature: 0°C to +40°C

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• Relative humidity: 15% to 85%
• Atmospheric pressure: 86 kpa ~ 106 kpa
Storage & Packaging
Each sensor is individually packaged.
The sensor must be stored in its original packaging and within the
storage conditions to maximize the storage life.
Storage conditions are as follows:
• Ambient temperature: -10°C to +40°C
• Relative humidity: 15% to 85%
• Atmospheric pressure: 86 kpa ~106 kpa
Shelf Life
5 years.
Warranty & Liability
Orantech oers 12 months warranty against defects in material or
workmanship from the date of purchase. But does not include the
damage or breakage due to the abusive use or negligent care of
the sensors.
Orantech reserves the right to perform warranty service at its
own facility. We guarantee that the products conform to the

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specications of the safety and performance standards currently in
force and applicable to it.
Warning
The sensors should not be xed to an exposed tissue injury
site. Do not use for hyperactivity blood oxygen monitoring.
• The sensors are designed for use with specic monitors.
• The operator is responsible for checking the compatibility of the
monitor, sensor and cable before its use.
• Incompatible components can result in degraded accuracy and
performance.
• Consult the operation instructions for the equipment and the
related accessories before operating equipment to ensure their
compatibility.
• Portable and mobile RF communications equipment can aect
the equipment.
• Do not immerse connector ends in cleaning solution(s).
• Do not allow service or maintenance on the sensor while being
used on a patient.
• No modication of this sensor is allowed.
• The sensors are tested for biocompatibility, there is no risk to

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the human body.
Warning: MR Unsafe!
Do not expose the device to a magnetic resonance (MR)
environment.
• The device may present a risk of projectile injury due to the
presence of ferromagnetic materials that can be attracted by
the MR magnet core.
• Thermal injury and burns may occur due to the metal
components of the device that can heat during MR scanning.
• The device may generate artifacts in the MR image.
• The device may not function properly due to the strong
magnetic and radiofrequency elds generated by the MR
scanner.
Caution
Federal (U.S.) Law restricts this device to sale by or on the order of
a physician.
Waste Disposal
Please refer to your local laws and regulations for information on
how to dispose of SpOsensors.