Integrated Pulse Oximetry Device Specifications 1. Oxygen Saturation Range 2. Pulse Rate Range Red - 660 Nanometers Infrared - 925 Nanometers Heart Rate No Motion - Adults Motion - Adults Low Perfusion - Adults No Motion (18 - 300 BPM) - Adults Motion (40 - 240 BPM) - Adults Low Perfusion (40 - 240 BPM) - Adults ±2 digits ±3 digits ±3 digits ±3 digits ±5 digits ±3 digits Temperature a) Operating b) Non Operating Humidity a) Operating b) Non Operating Power Draw Voltage Input 2 to 6 volts dc operating Note: Sensor is not isolated from input voltage Output Digital Signals Patient Isolation Meets IEC 60601-1 Dielectric Withstand Leakage Current 100g (including 1m cable and connector) Ruggedness immersion a) Shock b) Vibration ♦ Standard Deviation is a statistical measure: up to 32% of the readings may fall outside these limits. 4106-000 REV 06

INPUTS: Red Wire = V+ (2-6VDC, 60mW typical) Black Wire = Ground Cable Shield = Ground (Both Black wire and cable shield must be attached to ground on the host device) Note: Sensor is not isolated from input voltage. OUTPUTS: Green Wire = Serial Output (TTL) Blue Wire = Serial Output (RS-232) FORMATTING OPTIONS: PART # SERIAL DATA FORMAT # SERIAL DATA FORMAT #1: 1) Serial format 2) Rate 3) Data 9600, n, 8, 1 Sends 3 bytes of data once a second. ALWAYS SET TO "1" SENSOR DISCONNECTED, SET IF TRUE OUT OF TRACK, SET IF TRUE LOW PERFUSION, SET IF TRUE MARGINAL PERFUSION, SET IF TRUE BAD PULSE, SET...

SERIAL DATA FORMAT #2: 1) Serial format 9600, n, 8, 1 2) Rate Sends 5 bytes of data 75 times a second. 3) Data a. HR value bits 7&8 (128-511), 511 = bad data 1 byte 3 times a second b. HR value bits 0-6 (0-127) 1 byte 3 times a second c. SpO2 value 0 - 100 1 byte 3 times a second d. Firmware revision level 1 byte 3 times a second e. Status byte 128 - 255 1 byte 75 times a second Bit 0 frame Sync, set for 1 of 25, clear for 2-25 of 25 Bit 1 green perfusion, set if true only during pulse Bit 2 red perfusion, set if true only during pulse Bit 3 sensor alarm, set if true Bit 4 out of track, set if...

Data is sent in the following format Hz 1/75 STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH STATUS PLETH...

IPod Precautions for Use Contraindications • Explosion Hazard: Do not use the Ipod in an explosive atmosphere or in the presence of flammable anesthetics or gases. Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors (e.g., blood pressure cuff) hinder pulse measurements. As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation. This device does not meet defibrillation-proof requirement per IEC 60601-1: 1990, clause 17.h. This device should not be used adjacent to...

Intended Use The Ipod is intended to provide medical device manufacturers with a small, low-power device that can be easily integrated into a host device. The module measures functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (BPM) for adult, pediatric, and neonatal patients. When mated with a medical device manufacturer’s host system, the Ipod may be used in any environment where pulse oximetry measurements are made. Manufacturer’s Declaration Refer to the following table for specific information regarding this device’s compliance to IEC Standard 60601-1-2. Table 1: Electromagnetic...