background image

120

Note: 

U

is the a.c. mains voltage prior to application of the test level.

Surge

IEC 61000-4-5

±1 kV line (s) 

to line(s)

±2 kV line(s) 

to earth

N/A

N/A

Voltage dips, 

short 

interruptions

and voltage

variations on

power supply

input lines 

IEC 61000-4-11

<5 % 

U

T

 

(>95 % dip in 

U

T

)

for 0.5 cycle 

40 % 

U

T

(60 % dip in 

U

T

)

for 5 cycles 

70 % 

U

T

(30 % dip in 

U

T

)

for 25 cycles 

<5 % 

U

T

(>95 % dip in 

U

T

)

for 5 s

N/A

N/A

Power frequency

(50/60Hz)

magnetic field

IEC61000-4-8

3 A/m

3 A/m

Power frequency magnetic 

fields should be at levels 

characteristic of a typical 

location in a typical com-

mercial or hospital envi-

ronment.

Table 3: Guidance and manufacturer’s declaration – electromagnet-

ic immunity

The device is intended for use in the electromagnetic environment spec-

ified below. The user of this device should assure that it is used in such 

an environment.

NOTA 1

: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTA 2

: These guidelines may not apply in all situations. Electromagnetic propagation 

is affected by absorption and reflection from structures, objects and people.

Summary of Contents for 35091

Page 1: ...et bien comprendre ce manuel avant d utiliser le produit ACHTUNG Diese Anleitung muss vor dem Einsatz des Produkts aufmerksam gelesen und vollst ndig verstanden werden ATENCI N Los operadores tienen q...

Page 2: ...d please change the position of Pulse Oximeter For the individual patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue...

Page 3: ...OT press the keys on front panel with sharp materials or sharp points High temperature or high pressure steam disinfection to the oximeter is not permitted Refer to User s Manual for instructions of c...

Page 4: ...re those hemoglobins which release oxygen 2 1 Features Large true color OLED display of SpO2 PR Pulse Bar PI Plethys mogram Innovative 4 directions display Automatic power on off Audible visible over...

Page 5: ...absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO2 and deoxygenated hemoglobin Hb have...

Page 6: ...e oxygen There is an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing Factors causing low SpO2 Measuring valu...

Page 7: ...cent lamp dual ruby light infrared heater direct sunlight and etc G Strenuous action of the subject or extreme electrosurgical interfer ence may also affect the accuracy 3 BATTERY INSTALLATION 1 Press...

Page 8: ...ct position and then clip the finger 3 The device will power on automatically in 2 seconds and start to dis play software version number 4 Next enter into data display screen as shown in Figure 4 The...

Page 9: ...direction Four directions display alternately Short time press Display Key to flip the screen 90 each time in a cyclical manner as shown in Figure 4 When the screen displays towards the left side the...

Page 10: ...ual wavelength LED sensor with wavelength Red light 663 nm Infrared light 890 nm Maximal average optical output power 1 5mW Measuring range 35 100 Measuring accuracy 3 for SpO2 range from 70 to 100 Sp...

Page 11: ...dical Index 2 series while setting the emulating interfer ence of sun light and 50Hz 60Hz fluorescent light J Dimensions 60 mm L 33 mm W 30 mm H Net Weight 35g including battery K Classification The t...

Page 12: ...E The Pulse Oximeter is calibrated in the factory before sale so there is no need to calibrate it during its life cycle However if it is necessary to verify its precision routinely the user can do the...

Page 13: ...is not placed far enough inside 2 The finger is shaking or the patient is moving 1 Place the finger correctly inside and try again 2 Let the patient keep calm Cannot turn on the device 1 The batteries...

Page 14: ...nings carefully Keep away from sunlight Follow instructions for use Keep in a cool dry place SpO2 Oxygen saturation percentage Medical Device complies with Directive 93 42 EEC PR Pulse rate beats per...

Page 15: ...dity of the warranty GIMA will repair and or replace free of charge all the defected parts due to production reasons Labor costs and personnel traveling expenses and packaging not includ ed All compon...

Page 16: ...ser of this device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment RF emissions CISPR 11 Group 1 This device uses RF energy only for its inte...

Page 17: ...61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com mercial or hospital envi ronment Table 3 Guidance and manufacturer s dec...

Page 18: ...termined by an electromagnetic site survey a should be less than the compli ance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a...

Page 19: ...paration distance according to frequency of transmitter m 150 kHz to MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 For transm...

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