Reusable Veterinary SPO2 Sensor User Manual

Intended Use & Indications for Use

The SpO2 SENSORS are intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). These compatible replacement sensors are intended for use with major pulse oximeter brands. The SpO2 sensors 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.

It may be used in the hospital, clinical environment, homecare, and during emergency land transportation. The SpO2 sensors works with Compatible device providing SpO2 and pulse rate on horse, rabbit、 dog and cat.

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 heart rate conditions.

Installation

• Connect the SpO2 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 tongue or anus for animal.
• Apply the sensor to the animal.
• 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.
• 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.
• Chemicals used in some cleaning agents may cause brittleness of plastic parts. Follow cleaning instructions in this manual.
• All user and patient accessible materials are non-toxic.
• The pins of plug must not be in contact with the cleaning fluid, otherwise it will cause permanent damage to the SpO2 sensor.

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.
• Do not use and discard any sensor that appears to have any mechanical or electrical flaws.

• Ambient temperature: 0 to +40°C
• Relative humidity: 15 to 85%
• Atmospheric pressure: 86kpa ~106kpa
  
  

• Ambient temperature: -10 to +40°C
• Relative humidity: 15 to 85%
• Atmospheric pressure: 86kpa ~106kpa

Warranty

Cables & Sensors offers a one-year warranty against defects in material and workmanship from the date of purchase. Cables & Sensors does not cover the damage or breakage due to the abusive use or negligent care of the sensors.
Cables & Sensors guarantees that the equipment conforms to the specifications of the safety and performance standards currently in force and applicable to it.

Warning

1. The sensors should not be fixed to a tissue injury site. Do not use for hyperactivity blood oxygen monitoring.
2. The sensors are designed for use with specific monitors.
3. The operator is responsible for checking the compatibility of the monitor, the sensor and cable before its use.
4. Incompatible components can result in degraded accuracy and performance.
5. Consult the operation instructions for the equipment and the related accessories before operating equipment to ensure their compatibility.
6. Portable and mobile RF communications equipment can affect the equipment.
7. Do not immerse connector ends in cleaning solution(s).
8. Do not allow service or maintenance the sensor while being used on a patient.
9. No modification of this sensor is allowed.
10. The sensors are tested for biocompatibility, there is no risk to the human body.
11. Do not use this device in the presence of flammable anesthetics or other flammable substance in combination with air, oxygenenriched environments, or nitrous oxide.
12. This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the information in this manual before using the device.
13. 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.
14. Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, will affect the accuracy of the SpO2 measurement.
15. Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings.
16. Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, will affect the accuracy of the SpO2 measurement.
17. Optical cross-talk can occur when two or more sensors are placed in close proximity. It can be eliminated by covering each site with an opaque material.
18. Tissue damage may result from overexposure to sensor light during photodynamic therapy with agents such as verteporphin, porfimer sodium, and metatetrahydroxyphenylchlorin (mTHPC).
19. Change the sensor site at least every hour and observe for signs of tissue damage. More frequent sensor site changes/inspections may be indicated depending upon the photodynamic agent used, agent dose, skin condition, total exposure time or other factors. • Use multiple sensor sites.
20. Under certain clinical conditions, pulse oximeters may display dashes if unable to display SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury.

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:
U.S. federal 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 SpO2 sensors.

Symbol Explanation

	Manufacturer
	Catalog number
	Batch code
	Series number
	Latex-free
	Non-sterilized
	See instructions
	Caution
	Date of manufacture
	Crossed out wheelie bin indicates separate treatment from general waste at end of life. Waste of Electrical and Electronic Equipment Directive (WEEE)
	Protection against moisture
	U.S. federal law restricts this device to sale by or on the order of a physician.
	European Authorized Representative
	CE Mark
	Type BF Equipment