Oxitone 1000M
User Manual Rev. 1.
Page 8 of 39
4. SAFETY
4.1. ELECTRICAL SAFETY
The device complies with requirements of IEC/EN 60601-1 for general requirements for safety of
medical electrical equipment:
Class II Equipment type BF applied part
Mode of operation: Spot check
Degree of mobility: Portable.
4.2. EMC COMPLIANCE
This device has been tested and found to comply with the IEC60601-1-2:2007 standard and with
CISPR 11:2009+A1(10) Group 1 Class B limits
4.3. SAFETY INSTRUCTIONS
Warnings
Do not use with patients with significant deformity, swelling, irritation, degenerative changes or
edema of the hand wrist.
Do not use with patients with localized infection, ulceration or skin lesions involving the wrist.
Do not use with patients that have restricted blood flow e.g. tourniquet, pressure cuff or IV line.
Do not use with patients with tremors or convulsions.
Do not use with patients with peripheral vascular disease affecting the hands.
Do not use with neonatal or pediatric patients.
This device is not defibrillation proof per IEC60601-1.
Do not use the device in an MR environment or in an explosive atmosphere.
In case of discomfort, inspect the device sensor application site to ensure correct sensor
alignment and skin integrity.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin
beneath the sensor (device straps tighten).
The Oxitone 1000M is located on the patient wrist to activate the device properly. Check the
application site every 4 hours for skin integrity. If there is any concern, remove the Oxitone
1000M and replace with another pulse oximeter with a different application site.
Patient sensitivity varies depending on medical status or skin condition.
This device is intended only as an adjunct in patient assessment it must be used in conjunction
with other methods of assessing clinical signs and symptoms.
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