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Instructions for Use Skin Temperature Sensor Thermistor: YSI 400 Series Equivalent Cat. No.: 400-SK

DESCRIPTION: CONTRAINDICATIONS: Hyperthermia and hypothermia are frequently The Starboard Medical Skin Temperature sensor is experienced clinical conditions and their undesirable contraindicated for usage over traumatized and effects in patients have been well documented in the hypo-perfused areas. literature. Body temperature is measured continuously using disposable temperature sensors ADVERSE REACTIONS: or probes to detect hyper- or hypo- thermia. These The following adverse reactions have been reported sensors are inserted in the structure designed to fit a during clinical application of the skin temperature specific anatomy of the human body where sensors: temperature is measured. The main component of  Skin irritations. the temperature sensors is a chip which changes  Skin burns due to aberrant electro-cautery resistance with a change in temperature. The chip radio-frequency current pathways. used in the Skin Temperature Sensor is a thermistor equivalent to a YSI 400 series. This thermistor is DIRECTIONS FOR USE: encapsulated in a plastic cap connected to a lead 1. Dry skin in the area where the sensor is to be wire. This lead wire has an insert molded connector placed. on the opposite end, to connect with the instrument 2. Remove the paper backing, and place the cable. The accuracy of the sensor is: ±0.1˚C at 37˚C sensor in the dry skin area of axila, forehead and ±0.2˚C at 5˚C and 45˚C. or any other skin surface as clinically indicated. The Starboard Medical skin temperature sensor is 3. Align the temperature sensor’s connector with designed for placement on the surface of the skin. In the instrument’s cable connector and push order to minimize the interference of the ambient firmly to assure proper contact. Forced temperatures with the skin temperature misalignment may cause sensor to fail. measurement, the sensor is covered with closed cell foam and a Mylar metallic film. The thermistor WARNINGS: temperature sensor is placed in the center of the If the Skin Temperature sensor is utilized during foam cut out to prevent pressure on the skin below surgical procedures using electro-cautery, the the sensor. The adhesive on the foam surface holds following may occur: the skin sensor in situ. The probes are disposable  Artificial fluctuations in temperature readings. and designed to be used with instruments that are  Localized tissue burns due to the thermistor and compatible with YSI 400 series or equivalent lead wire acting as an alternate path for the thermistors. The cables to connect the probe to the radio-frequency current to return to ground. instrument are Starboard Medical Cable Cat. No. The risk of localized tissue burns can be minimized C400MP-M, C400MP-MJ, C400P-M, and C400P- by having the active and ground probes of the MJ, or SMITHS Level 1 Cable Cat. No. C400-10. electro-cautery system in a close proximity to each The device is sterile, designed to be disposable, for other. All parts of the Skin Temperature sensor and single use only. cable shall be away from the electro-cautery probes and connecting cables and, therefore, outside of the INDICATIONS: radio-frequency current field. The Starboard Medical Skin Temperature sensor is intended for continuous monitoring of skin Starboard Medical, LLC temperature. 22845 Savi Ranch Parkway Suite H Yorba Linda, CA 92887

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INS400-SK Rev. A