Orantech SpO2 User manual
User Manual
Single-patient-use SpO2 Sensors
The difference you can sense
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Intended Use & Indications for Use
The SpOsensors 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 SpOsensors are designed to
match the specifications of the original equipment manufacturer,
therefore confirm 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
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which is used to calculate and display oxygen saturation levels and
heart rate conditions.
Installation
• Connect the SpOsensor to the oximeter’s adapter cable.
• Turn the oximeter on and verify proper operation.
• Select the sensor site on the patient. The preferred sensor sites
are the index finger for adult and children, the great toe for
infants, and on the foot below the toes for neonate.
• Place the sensor on the patient.
Adult (>40Kg) Pediatric (10-50Kg) Infant (3-20Kg) Neonate (<3Kg)
• 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.
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Caution
• Place the sensor on the index finger ensuring the finger is fully
inserted and the tip of the finger rests against the finger stop
inside the sensor.
• Possible alternate sites are small-sized thumb, middle and ring
fingers as well as the little finger or the big toe.
• Ensure the fingernail is located under the finger stop on the
SpOsensor clamp.
• The sensor must not be located on the same arm as the blood
pressure cuff, arterial catheter or intravascular line.
• Remove all nail polish as this can affect accuracy.
• Do not use the sensor inside or near an MRI.
• Avoid intense light sources near the sensor.
• The sensor site must be inspected at least every eight (8) hours;
and if the circulatory condition or skin integrity has changed,
the sensor should be applied to a different site.
• The site must be checked frequently or per clinical protocol to
ensure adequate adhesion, circulation, skin integrity and correct
optical alignment.
• Exercise caution with poorly perfused patients; skin erosion
and pressure necrosis can be caused when the sensor is not
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frequently moved. Assess site as frequently as every (1) hour
with poorly perfused, patients and move the sensor if there are
signs of tissue ischemia.
• Circulation distal to the sensor site should be checked routinely
• During low perfusion, the sensor site needs to be assessed
frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
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.
• Do a visual check (appearance of insulators, connector contact
pins, etc.).
• Verify the mechanical integrity of the connectors.
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Do not use and discard any sensor that appears to have any
mechanical or electrical flaws.
Performance, Reliability, Safety,
Compatibility & Mechanical Integrity
• Performance/Reliability
This SpOsensor with its compatible pulse oximeter has been
validated and tested for compliance with ISO 80601-2-61.
Comparative value measurement in % saturation:
SpOrange (70%-100%) -Accuracy ±3%
SpOrange (<70%) -No specified
Pulse rate range: 35-240 bpm -Accuracy ±2 bpm
Low perfusion: SpOrange (70%-100%) -Accuracy ±3%
Pulse rate range: 35-240 bpm -Accuracy ±3 bpm
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• Peak Wavelength and Maximum Output Power
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
Classification 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 SpOsensor should only be used with the specified
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
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demanding hospital environment. The solid connectors are fitted
with flexible sleeves to minimize the risk of cable breakage. They
have no accessible metallic parts.
Operating Conditions
• Ambient temperature: 0°C to +40°C
• Relative humidity: 15% to 85%
• Atmospheric pressure: 86 kpa ~ 106 kpa
Storage & Packaging
Each sensor is individually packaged.
Sensors 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
2 years.
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Warning
The sensors should not be fixed in the tissue injury site, not
for hyperactivity of blood oxygen monitoring.
• The sensors are designed for use with specific 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 concerned
and the related accessories before operating equipment to
ensure their compatibility.
• Portable and mobile RF communications equipment can be
affect equipment.
• Do not immerse connector ends in cleaning solution(s).
• Do not allow service or maintenance on the sensor while used
on a patient.
• No modification of this sensor is allowed.
• The sensors are tested by biocompatibility, there are not any risk
to the human body.
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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 fields 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 SpOsensors.
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Manufacturer Caution
Date of manufacture
Authorized
Representative in the
European Community
Crossed out wheelie
bin indicates separate
treatment from
general waste at
end of life. Waste
of Electrical and
Electronic Equipment
Directive (WEEE)
Catalogue number
Batch code
Serial number
Not made with
natural rubber latex
Protection against
vertically falling
water drops
Type BF Applied Part
Single patient use
Use-by date
Non-sterile
Consult electronic
instructions for use
CE Mark
Federal (U.S.) Law
restricts this device
to sale by or on the
order of a physician
Title of Symbol
Unique Device Identifier
Medical device
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REF: M20-M008
Rev: A2
Cables and Sensors B.V.
Zekeringstraat 21B 1014 BM Amsterdam, Netherlands
Orantech Inc.
Zone#A, 4F, 1st Bld, 7th Industrial Zone, Yulv Community, GongMing,
Guangming New District, Shenzhen, China 518106
www.orantech.com
Support
To get the support, please contact the representative of manufacturer or local distributor.
The categories shown below are available for sale through the local distributors or e-commerce.
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