Solaris S200A Directions For Use

Intended Use
Patient Type
Patient Weight
When used with a compatible patient monitor or a pulse oximeter device, the Solaris sensor is intended to be used for continuous, non-invasive functional arterial
oxygen saturation (SpO2) and pulse rate monitoring of patients.
Caution
1. This sensor is for use only with compatible patient monitors or pulse oximeter devices.
2. This sensor satisfies the compatibility between the materials used with which the patient or any other person can come into contact and biological tissues.
Contraindications
The Solaris sensor is contraindicated for use on active patients or for prolonged use.
Specifications
SpO2 Accuracy（RMS）: ≤±2% （±1SD）, 70-100% SpO2; Pulse Rate Accuracy: ±2 digits, 30-250BPM, Peak Wavelength: Red: 660-666nm, Infrared: 880-950nm;
Maximum Optical Output Power: 150mW.
Note: 1.RMS is meaning root-mean-square.
2. The SpO2 accuracy has been clinically assessed.
3. A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter.
Compatible Devices
Nellcor, BCI, GE, Goldway, Invivo, HP, Siemens, Spacelabs, Mindray, Datex, CSI, Datascope, Nihon Kohden, Novametrix, Ohmeda, etc.
Note: The compatible devices should comply with IEC 60601-1.
Cleaning & Disinfection
Unplug the sensor before cleaning or disinfecting.
1) Dip clean the sensor part (not the connector) in a mild detergent solution, or a 70% isopropyl alcohol solution. If low-level disinfection is required, use a 1:10
bleach solution.
2) Rinse the sensor part (not the connector) in water, wipe it with a dry cloth and leave to dry completely.
Caution
Do not sterilize by irradiation steam, or ethylene oxide.
Storage and Operating Temperatures
Storage: -20 ~ +55°C Operating: +5 ~ +40°C
Warnings: Patient Safety
l This sensor is for use only with compatible patient monitors or pulse oximeter devices.
l Check the site every 2 hours (more frequently if perfusion is poor).
l Routinely check to ensure adequate distal circulation to the sensor site.
l Carefully route cables to reduce any possibility of patient entanglement or strangulation.
l Patient conditions (such as reddening, blistering, skin discoloration, ischemic skin necrosis, and skin erosion) may warrant changing the site frequently or using a
different style of sensor.
l Do not use the sensor if the sensor or the sensor cable appears damaged.
l This device is not intended for use in a magnetic resonance imaging (MRI) environment.
Warnings: Data Validity
l Conditions that may cause inaccurate reading and impact alarms include interfering substances, excessive ambient light, electrical interference, excessive motion, low
perfusion, low signal strength, incorrect sensor placement, poor sensor fit, and movement of the sensor on the patient.
l Do not use a blood pressure cuff or arterial blood pressure measurement device on the same limb as the sensor site.
l It is possible for any device to malfunction; therefore, always verify unusual data by performing a formal patient assessment.
Warranty
Solaris offers a 12-month warranty against manufacturing defects in materials and workmanship from the original date of purchase.
Compliance
l EMC Compliance: IEC60601-1-2，Group I，Class B.
l Equipment Classification：Class IIb, MDD 93/42/EEC.
l Degree of Protection：Type BF-Applied Part.
l IPX1 Approved.
Definitions of Product Symbols
Warning: See Directions for Use
The probes comply with the requirements of the Council Directive 93/42/EEC.
concerning medical devices with identification No. 0123
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Authorized Representative in the European Community:
Shanghai International Trading Corp. GmbH (Hamburg)
Be taken to separate collection at the end of product life. Do not dispose of the
product as unsorted municipal waste.
Solaris Medical Technology, Inc.
Zhongjian Industry Building One, #301
18 Yanshan Road, Shekou, Nanshan District
518067 Shenzhen, Guangdong,
Multi-Compatible Reusable SpO2 Sensors
Directions for Use
Neonatal
1- 4 kg
P. R.
CHINA
Infant
3 – 15 kg 10 – 40 kg
P/N
SN
SCE-0010-01-01-N
Pediatric
﹥40 kg
Protection against moisture
Contains no latex
Manufacturer: Solaris Medical Technology, Inc.
Part Number
Serial Number
Type BF applied part
Shanghai International Trading Corp. GmbH
Eiffestrasse 80
20537 Hamburg
GERMANY
(Rev. 2.1)
Adult
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