INTEND USE
GM600 series Pulse Oximeter is intended for measuring functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in home and
professional caring environment, and transport and mobile environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inch ~ 0.9 inch) and for patients during no-motion condition.
PHYSIOLOGICAL PRINCIPLE
GM600 determines SpO2 by measuring the absorption of red & infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to
determine SpO2 reading and pulse rate.
WARNING
• Do not use the oximeter in an MRI or CT environment.
• The oximeter is intended as an adjunct in subject assessment. It must be used in conjunction with other methods to assess clinical signs and symptoms.
• Do not use the oximeter in an explosive atmosphere to avoid explosion hazard.
• If the monitoring sites have trauma, disability or other medical conditions, users should consult doctors before use.
• The oximeter has to measure the pulse properly to obtain accurate SpO2 reading. Blood flow restrictors (e.g., blood pressure cuffs) may hinder pulse measurements. Remove any objects that may hinder the
performance of the oximeter.
• Please do not leave the device to a child and always keep the battery cover in attach to avoid swallowing by a child.
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• This oximeter is not an apnea monitor.
• Significant levels of dysfunctional hemoglobin such as carbonxyhemoglobin or methemoglobin may affect the accuracy of the measurement.
• Cardio green and intravascular dyes may affect the accuracy of pulse oximeter.
• The performance of the oximeter might be affected by the presence of a defibrillator.
• The oximeter may not work on all subjects. If you are unable to achieve stable readings, please discontinue use.
• The oximeter has motion tolerant algorism to minimize the possible motion artifact. However, the oximeter may be still interpreted by motion. Please minimize subject motion as much as possible.
• All the materials of the oximeter in contact with a patient or a user have passed
ISO10993 Biological evaluation of medical devices accordingly. It shall be no toxicity harm to children, pregnant or nursing women.
CAUTION
• GM600 series can be operated by either a patient or a trained personnel. Consult healthcare professionals before use.
• The oximeter might not work on cold extremities due to poor circulation. Please warm or rub the finger , or
reposition the device to improve the reading.
• Check the device applied site frequently to evaluate body circulation and skin sensitivity. The recommended maximum applied time at a single spot is 4 hours. Misapplication of the oximeter on applied site with excessive pressure for prolonged periods can introduce pressure injury.
• Do not spray, pour, or spill any liquid on the oximeter, accessories, switches or openings.
• Do not use caustic or abrasive cleaning agents on the oximeter.
• This is a precision medical instrument and must be repaired by qualified personnel from manufacturer only.
• Please follow local governing ordinances and recycling instructions regards disposal or recycling of the device and components.
