Visomat Pulsoximeter PO70 Handleiding

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EN-EN-EN-EN-EN-EN-

Table  Guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The

customer or the user of the device should ensure that it is used in such an environment.

Emission measurementsCompli-

ance

Electromagnetic environment - guidance

RF emissions CISPR Group The device uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in

nearby electronic equipment.

The device is suitable for use in all establish-

ments, including domestic establishments

and those directly connected to the public

low-voltage power supply network that supplies

buildings used for domestic purposes.

RF emissions CISPR Class B

Harmonic currents

according to IEC

--

N/A

Voltage fluctuations/

flicker according to IEC

--

N/A

Table  Guidance and manufacturer’s declaration - electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The

customer or the user of the device should assure that it is used in such an environment.

Immunity testsIEC  test levelCompliance

level

Electromagnetic environment

- guidance

Electrostatic

discharge (ESD)

according to IEC

--

± kV contact

± kV air

± kV

contact

± kV air

Floors should be wood, con-

crete or ceramic tile. If floors

are covered with synthetic

material, the relative humidity

should be at least  %.

Electrical fast

transient/bursts

according to IEC

--

± kV for power

supply lines

± kV for input/output

lines

N/AN/A

Surges according

to IEC --

± kV line(s) to line(s)

± kV line(s) to earth

N/AN/A

Voltage dips,

short interrup-

tions, and voltage

variations

according to

IEC--

< % U

T

(> % dip in

UT) for . cycle

< % U

T

( % dip in

UT) for  cycles

< % U

T

( % dip in

UT) for  cycles

< % U

T

(> % dip in

UT) for  sec.

N/AN/A

Power frequency

(/ Hz)

magnetic field

IEC --

 A/m A/mPower frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical commercial

or hospital environment.

NOTE: U

T

is the AC mains voltage before the test level is applied

Table  Guidance and manufacturer’s declaration - electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The

customer or the user of the device should assure that it is used in such an environment.

Immunity testIEC 

test level

Compli-

ance level

Electromagnetic environment - guidance

RF interfer-

ence conduct-

ed through

cables ac-

cording to IEC

--

 Vrms

 kHz to

 MHz

N/APortable and mobile RF radio equipment should be

used no closer to any part of the device, including

cables, than the recommended separation distance

calculated from the equation applicable to the

frequency of the transmitter. Recommended

separation distance:

d=.√P

d=.√P  MHz to  MHz

d=.√P  MHz to . GHz

where P is the maximum output power rating

of the transmitter in watts (W) according to the

transmitter manufacturer and d is the recom-

mended separation distance in metres (m).

b

Field

strengths from fixed RF transmitters, as deter-

mined by an electromagnetic site survey

a

, should

be less than the compliance level in each frequency

range

b

. Interference may occur in the vicinity of

equipment marked with the following symbol:

Radiated RF

interference

according to

IEC --

 V/m 

MHz to .

GHz

 V/m

Table  Recommended separation distances between portable and mobile RF communi-

cations equipment and the device.

The device is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the device can help prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the device as recommended

below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

W

Separation distance according to frequency of transmitter m

 kHz to  MHz

d = .√P

 MHz to  MHz

d=.√P

 MHz to , GHz

d=.√P

...N/A

.N/A..

..N/A

.N/A.

N/A

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in metres (m) can be estimated using the equation applicable to

the frequency of the transmitter, where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter manufacturer.

NOTE: At  MHz and  MHz, the higher frequency range applies.

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

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

NOTE : At  MHz and  MHz, the higher frequency range applies.

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

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

a:

Field strength from fixed transmitters, such as base stations for radio (cellular/cord-

less) telephones and land mobile radios, amateur radio, AM and FM radio stations and TV

stations cannot be predicted theoretically with accuracy. To assess the electromagnetic

environment due to fixed RF transmitters, an electromagnetic site survey should be con-

sidered. If the measured field strength in the location in which the device is used exceeds

the applicable RF compliance level above, the device should be observed to verify normal

operation. If abnormal performance is observed, additional measures may be necessary,

such as reorienting or relocating the device.

b:

Over the frequency range  kHz to  MHz, field strengths should be less than  V/m.

Pulse oximeter PO70

Instructions for use



IP

Technical data

Explanation of symbols

Standards applied

Electromagnetic compatibility (EMC)

The manufacturer hereby declares that the device complies with

the following standards:

IEC -:  Medical electrical equipment – Part: General

requirements for basic safety and essential performance

BS/EN/ISO : or the equivalent ISO --: –

Medical electrical equipment – Part-: Particular requirements

for the basic safety and essential performance of pulse oximeter

equipment

Complies with the provisions of Council Directive //EEC con-

cerning medical devices

The device is medical electrical equipment and is subject to spe-

cial EMC precautions, which must be published in the operating

instructions.

Portable and mobile RF communications equipment may affect

the equipment. Using the device with non-approved accessories

can adversely affect the device and change the EMC. The device

should not be used immediately adjacent to or between other

electrical devices. The device meets the EMC requirements set

out in international standard IEC--:. The require-

ments are met under the conditions described below.

Shenzhen Creative Industry Co., Ltd.; Floor , BLD,

Baiwangxin High-Tech Industrial Park, Songbai Road,

Xili Street, Nanshan District, , Shenzhen, China

Shanghai International Holding Corp. GmbH (Europe)

Eiffestraße ,  Hamburg, Deutschland

Disposal

This product complies with Council Directive //EEC of

 September  concerning medical devices and bears

the mark CE  (TÜV SÜD Product Service GmbH).

Technical equipment and batteries do not belong in

household waste. They must be disposed of at appropri-

ate collection and disposal points.

Degree of protection against electric shock: TYPE BF

Consult the instructions for use

Medical product

Reference number = article number

Device serial number

Manufacturer

Authorised representative in the European Union

Protected against solid foreign bodies with a diameter of

.mm and above, protection against dripping water.

Sensor:Dual-wavelength LED sensor with red

light at nm and infrared light at

nm.

Maximum average

optical output:

≤mW

SpO2display range:%–%

SpO2measurement

accuracy:

≤% for SpO2and in the range from %

to %

Pulse rate display

range:

–bpm

Pulse rate measure-

ment accuracy:

±bpm or ±% (whichever is greater)

Perfusion index (PI)

display range:

–%

Lower limit adjustment

range for SpO2:

–%, increment: %, default setting:

%

Lower limit adjustment

range for pulse rate:

–bpm, increment: bpm, default

setting: bpm

Upper limit adjustment

range for pulse rate:

–bpm, increment: bpm, default

setting: bpm

Power supply:×AAA/LR alkaline-manganese

batteries

Supply voltage: .V DC, operating

current: ≤mA

Operating conditions:Ambient temperature  to °C, relative

humidity  to %, air pressure  to

hPa

Conditions for storage

and transport:

Ambient temperature - to °C, relative

humidity  to %, air pressure  to

hPa

Low perfusion perfor-

mance:

The SpO2and PR measurement accuracy

is consistent with that previously stated,

even when the amplitude modulation is as

low as .%.

Impairment caused by

ambient light:

The difference between the SpO2reading

recorded under natural indoor light and

that recorded in a darkroom is less than

±%.

Size:mm (L)×mm (W)×mm (H)

Weight:approx. g (including batteries)

Protection against

electric shock:

Internal power supply, type BF applied

part

IP rating:IP: Protected against solid foreign bod-

ies with a diameter of .mm and above,

protection against dripping water.

Expected service life:years

Electromagnetic com-

patibility:

Group, ClassB

The pulse oximeter is calibrated at the factory before delivery so it

does not need to be recalibrated during its service life. SpO2simula-

tors should not be used to validate the accuracy of the pulse oximeter.

These may only be used as functional testers to review accuracy. The

SpO2accuracy stated here is supported by a clinical study conducted

in an independent research laboratory, in which hypoxia was induced

in healthy, non-smoking subjects with light to dark skin tones.



Pulse oximeter PO70

PZN-

Distributor:

UEBE Medical GmbH

Bgm.-Kuhn-Str. 

 Külsheim, Germany

[email protected], www.uebe.com

Subject to technical modifications.

Reprinting, including of extracts, is prohibited.

© Copyright  UEBE Medical GmbH

   AA - EN

Product specificaties