Hospitech Respiration AG Cuffill Mode D'emploi page 7

Guidance and manufacturer's declaration electromagnetic Immunity
The EQUIPMENT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EQUIPMENT should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
IEC 61000-4-3 20V/m
Radiated 80-2500MHz
MIL-STD-461E 20V/m
Radiated Immunity 100kHz-150kHz
20V/m 13.5MH-
13.6MHz
NOTE 1: At 80 MHz and 800 MHz, the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the AG Cuffill is used exceeds the applicable RF compliance level above, the [ME
EQUIPMENT or ME SYSTEM] should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the V-touch.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
IEC 61000-4-8 3 A/m
Magnetic Immunity
IEC 61000-4-2 15 kVAir
Electronic Discharge 9kV Contact
Guidance and Manufacturer's Declaration – Electromagnetic emission
Emission Test IEC 60601
Test Level
CISPR11 Class B
Caution: Federal law restricts
this device to sale by or on the
order of a physician or properly
licensed practitioner (Rx ONLY)
Compliance Electro-magnetic Guidance Level
Level
20V/m
Portable and mobile RF communications
80-2500MHz equipment should be used no closer to any
part of the AG Cuffill, including cables,
20V/m
than the recommended
100kHz-150kHz
distance calculated from the equation
20V/m 13.5MH-
applicable to the frequency
13.6MHz
transmiter.
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey (a) and 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:
Power frequency magnetic fields should be at
3 A/m
levels characteristic of a typical location in a
typical commercial or hospital environment.
15 kVAir Increasing relative humidity will reduce the
9kV Contact potential for ESD related difficulties.
Compliance Electro magnetic Guidance Level
Level
Complies The AG Cuffill is suitable for use in all
establishments, including
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
REF
Not for general waste
AG Cuffill information regarding Electro-Magnetic Compatibility (EMC)
As an electrical device, the AG Cuffill has been tested for electromagnetic emissions and is susceptible to
electromagnetic interferences within the required criteria of the IEC 60601-1-2 standard.
Warning:
The following warnings and informative tables are provided:
The AG Cuffill has been tested and found to comply with the limits for the medical devices to the IEC
60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a
typical residential installation. This device generates, uses and can radiate radio frequency energy and ,if
separation
not installed and used in accordance with the instructions, may cause harmful interference to other devices
in the vicinity.
of the
Recommended separation distance between portable and mobile RF communications equipment
and the AG Cuffill
The AG Cuffill is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the AG Cuffill can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the AG Cuffill as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter in meter
Output power of
Transmitter in Watts
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance
(d) in meters (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 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
domestic
absorption and reflection from structures, objects, and people.
Hospitech Respiration
20, Hamagshimim St P.O.B 7970
Kiryat Matalon Petach-Tikva
4934829, ISRAEL
Tel +972-3-919-1648
Fax +972-3-919-1647
59-10-100
Email:info@hospitech.co.il
150 kHz to 80 MHz 80MHz to 800 MHz 800MHz to 2.5GHz d=2.3√P
d=1.2√P d=1.2√P
0.12 0.12
0.37 0.37
1.17 1.17
3.69 3.69
11.67 11.67
0483
0.23
0.74
2.33
7.38
23.33
EC REP
Qsite EU. Gerrit van der Veenstraat 84HS,
1077 EL Amsterdam, The Netherlands
Tel +31(0)(20)811-0550
Fax +31 842-2131-42,
Email: QsiteEU@qsitemed.com