Toccare measures and displays the oxygen saturation (rSO2:%) and total hemoglobin index (T-HbI) of the touched site of the patient.
In May 2019, the certification was partially changed to allow for use in the oral cavity and vaginal (birth canal) area, whereas previously the measurement was limited to the skin of newborns and adults. This also allows to measure the head of the fetus in the birth canal during delivery.
Features
Toccare (KN-15) non-invasively measures the oxygenation state of biological tissue at a depth of about 5 mm from the body surface using light that does not affect the living body.
To use the instrument, fasten the main unit to the upper part of the forearm of the examiner’s dominant arm with the belt, and wear the sensor probe to the index finger. Attach the sensor probe to the index finger so that the light emitting/receiving part is on the belly of the index finger. Press and hold the power switch to turn on the power, it will display the calendar for 10 seconds, and then enter the measurement mode.
When the sensor probe gets contact with the body, the regional oxygen saturation (rSO2) and total hemoglobin index (T-Hb) of the area will be measured.
Measurement range:
rSO2: 0 to 99 (%).
T-HbI: 0 to 1.0.
During the measurement, pressing the power switch briefly will interrupt the measurement. Press the power switch briefly again to resume measurement. When the measurement is interrupted, “PAUSE” will be displayed.
Toccare is characterized by the fact that the sensor probe is attached to the examiner’s finger and is measured while palpating the patient. Compared to the conventional method where the sensor probe is attached to the patient, Toccare displays the blood oxygen saturation and hemoglobin levels in real time at the touched area, which is useful for early diagnosis of various diseases.
Specifications
| Measurement item | Regional Saturation of Oxygen: rSO2 (%) Total Hemoglobin index: T-HbI |
| Measurement range | rSO2: 0～99 (%) T-HbI: 0～1.0 |
| Sampling rate | 0.5 sec (fixed) |
| Trend graph display duration | 40 seconds/screen |
| Light source | LED (770nm , 830nm : nominal value) |
| Light output | 1 mW or less |
| Measurement method | SRS-NIRS |
| Battery | 2 AAA batteries |
| Rated Input | DC 3 V, 0.2 A max. |
| Battery duration | Approx. 5 hours or more (when using alkaline batteries) |
| sensor probe | Synthetic rubber (S and L size) |
| Sensor probe length | 40 cm |
| Size | Width: 60 mm Thickness: 26 mm Height: 82 mm Weight: 0.1 kg |
| Fixing belt | Width: 21 mm Length: 380 mm Made with flexible material |
| Medical device certification number | 227ADBZX00009000 (BSi) |
| Classification | Controlled medical devices Class II Controlled medical devices requiring special maintenance |
| Product name | Brand name | Model | Product code |
|---|---|---|---|
| Main unit | toccare | KN-15 | 001 |
| Probe | Sensor probe (L) | KN-15P(L) | 002 |
| Sensor probe (S) | KN-15P(S) | 003 | |
| Fixing belt | Fixing belt | KN-15B | 004 |
Handling precautions
- Please read the latest package insert and then use the device.
- Wear the sensor probe on your finger and wear clear surgical gloves on it.
- Avoid fat accumulation, hair and bone bulges, and do not take measurement on spots, hematomas or skin lesions.
- The sensor probe should not be inserted into any part of the body other than the natural opening of the anus.
- Do not reuse the sensor probe.
- It has been developed for single use in terms of quality and safety.
- When replacing the sensor probe, please turn off the power.
- Two sensor probes of different sizes are included with the main unit.