Reusable Temperature Probe User Manual

Intended Use & Indications for Use

Cables & Sensors temperature probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with Philips, Nihon Kohden and other monitors compatible with YSI 400 series temperature probes.
These devices are indicated for used by qualified medical personnel only.

The models of the probes are available for the following major brands: 

Operation Procedures:

1. Verify the compatibility of the probe. See the compatible label to ensure the device is compatible with the probe.
2. Make sure the probe plug matches the connector on the device. Then fully plug the probe into the device.
3. Place the probe tip on the site where temperature is being measured. Fix the probe tip with medical tape on the site if applicable.
   After the response time, the probe will start measuring.

Performance and Reliability:

The probes used with a compatible monitor have been validated and tested for compliance with ISO 80601-2-56.
Accuracy and stability: Probes are accurate and interchangeable with other probes with the same compatible connectors due to their similar temperature and resistor characteristics. The system accuracy is the sum of the probe and instrument accuracies.
Measurement range (25-45℃) ------Accuracy ±0.1℃
Response time (2 °C higher or lower than reference temperature source) -------- ≤150S
Minimum measuring time: 5mins
Degree of protection against electric shock: Type BF applied part
Degree of protection against the ingress of water: IPX2
Expected service life: 2 years. Visually inspect the probe for cracks, holes, crazing etc. prior to each use. If any such degradation in the cable jacket is discovered, discard probe according to your hospital’s procedure for medical waste.

Cleaning:

1. Wipe the probe, wire and plug assembly with a soft cloth dampened with the 70% isopropanol.
2. When wiping clean, hold the probe in one hand at the sensing tip and wipe the probe and lead wire toward the plug. Excessive pressure could stretch the cable jacket and break the internal wires, destroying the probe. Continued flexing of lead wires and cleaning can also break the internal wires.
3. Scrub the surfaces thoroughly one time, if visible contaminants remain, repeat scrub until no visible contaminants remain.
4. Wipe off the cleaning solution with a dry cloth after cleaning.

Disinfection (Skin probe, low-level):

1. Wipe the probe, wire and plug assembly with a soft cloth dampened with 70% isopropanol.
2. When wiping clean, hold the probe in one hand at the sensing tip and wipe the probe and lead wire toward the plug. Excessive pressure could stretch the cable jacket and break the internal wires, destroying the probe. Continued flexing of lead wires and cleaning can also break the internal wires.
3. Scrub the surfaces thoroughly one time, if visible contaminants remain, repeat scrub until no visible contaminants remain.
4. Rinse the probe thoroughly with sterile water for one minute.
5. Wipe off the disinfection solution with a dry cloth after disinfection.

Disinfection (Rectum probe, high-level):

1. Use a cidex activated glutaraldehyde solution (disinfection parameters are defined in the disinfectant’s instructions for use) according to the hospital standard.
2. Rinse the probe thoroughly for 1-2 minutes with sterile water.
3. Visually check the cleanliness of the equipment. If there are visible pollutants, repeat the above suggested wiping and rinsing procedure.
4. Wipe off the residual solution with a sterile gauze after disinfection.

Storage and Handling:

When not in use, probes should be loosely coiled and stored in room temperature. Don’t wrap probes around equipment to avoid damaging internal wires.

Operating conditions

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

Storage/Packaging

Probes are individually packaged.
Probes must be stored in its original packaging and within the storage conditions to maximize their storage life.
Storage conditions are as follows:

• 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 or 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 probes.
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 probes are designed for use with specific monitors.
   
2. The operator is responsible for checking the compatibility of the monitor, the sensor and cable before its use.
3. Incompatible components can result in degraded accuracy and performance.
4. Consult the operation instructions for the equipment and the related accessories before operating equipment to ensure their compatibility.
5. Portable and mobile RF communications equipment can affect the equipment.
6. Do not immerse connector ends in cleaning solution(s).
7. Do not service or maintain the probe while used on a patient.
8. No modification of this sensor is allowed.
9. If possible, remove the probe from patient contact before activating a surgical unit or other RF source.
10. If probes must be used together with electro surgical equipment, the instruments to which the probes are connected should be checked for adequate isolation from electrical grounds at radio frequencies.

CAUTION:

1. U.S. federal law restricts this device to sale by or on the order of a physician.
2. Mishandling of the probes could result in damage to internal wires and loss of electrical isolation or improper temperature readings.

Waste Disposal:
Please refer to your local laws and regulations for information on how to dispose of temperature probes.

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