EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
- 3 -
-WI-FI
● ●
-Battery
√ √
NOTE:
√
= Standard
●
= Optional
―
= Not Available
1.3 Instruction for Safe Operation
NOTE:
In this manual, Monitor refers to both F15 and F15 air, and is used where the information
applies to both models.
 The monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for
medical electrical equipment. It is class I equipment.
 The monitor operates within specifications at ambient temperatures between 0ºC (+32 ºF) and
+40 ºC (+104 ºF). Ambient temperatures that exceed these limits could affect the accuracy of the
instrument and cause damage to the modules and circuits. Allow at least 2 inches (5 cm)
clearance around the instrument for proper air circulation.
 You must check that the equipment, cables and transducers do not have visible evidence of
damage that may affect patient safety or monitoring capability before each use. If damage is
evident, replacement is recommended before use.
 The monitor must be serviced only by authorized and qualified personnel. The manufacturer does
not accept responsibility for safety compliance, reliability and performance if modifications or
repairs are carried out by unauthorized personnel. Identical replacement parts must be used.
 The typical operator's position is in front of the monitor. Please position the device in a location
where the operator can easily see the screen and access the operating controls.
 The protective degree against electric shock of the patient connections is:
Ultrasound (FHR1, FHR2, FHR3)
External TOCO
Fetal Movement Mark (FM)
Intrauterine Pressure (IUP)
Maternal Electrocardiography (MECG)
Direct Electrocardiography(DECG)
Fetal Electrocardiography (FECG)
Type CF
Non-invasive Blood Pressure (NIBP)
Arterial Oxygen Saturation (SpO
2
)
Temperature (TEMP)
Type CF, defibrillation-proof
The monitor described in this user manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
1.4 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the
following precautions during the operation of the instrument
WARNING
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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EDAN F15 Series Specifications

General

Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English