guidance and manufacturer's declaration - electromagnetic immunity

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TOP-3300 is intended for use in the electromagnetic environment specified below
The cutomer or the user of TP-3300 should assure that it is used in such an environment.
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immunity test

IEC60601
test level
compliance
level
electromagnetic environment -
guidance










conducted RF

IEC61000-4-6

radiated RF

IEC61000-4-3











3Vms
150kHz to 80MHz


3V/m
80MHz to 2,5GHz










10V/m



10V/m
portable and mobile RF
communications equipment should
be used no closer to any part of top-
3300, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
Distance
d = 0,35p



d = 0.35p 80MHz to 800MHz
d = 0.7p 800MHz to 2,5GHz

where P is the maximum output
power rating of the transmitter in
watts according to the transmitter
manufacturer and d is the
recommended separation distance
in metres (m).

field strengths from fixed RF
transmitters , as determined by an
electromagnetic site survey, a.
should be less than the compliance
level in each frequency range.

interference may occur in the
vicinity of equipment marked with
the following symbol :

NOTE 1 : at 80mhz and 800mhz, the higher frequency range applies.
NOTE 2 : these guidelines may no apply in all situations. electromagnetic propagation is
affected by absorbtion and reflection from structures, objects and people.

a. field strengths from fixed tranmitter, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannotbe predicted theoretically with accuracy. to assess the electromagnetic
environment due to fixed RF transmitter, an electromagnetic site survey should be considered. If
the measured field strength in the location in which TOP-3300 is used exceed the applicable RF
compliance level above, TOP-3300 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating TOP-3300.
b. Over the frequency range 150khz to 80 mhz, field strengths should be less than 10v/m.
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Recommended separation distances between
Portable and mobile RF communications equipment and TOP-3300
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TOP-3300 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The cus tomer or the user of TOP-3300 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and TOP-3300 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
150kHz to 80MHz
d = 0,35p
80MHz to 800MHz
d = 0,35p
800MHz to 2,5GHz
d = 0,35p
0.01 0.035 0.035 0.07
0.1 0.11 0.11 0.22
1 0.35 0.35 0.7
10 1.1 1.1 2.2
100 3.5 3.5 7

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For transmitter 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 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 absorbtion and reflection from structures, objects and people.
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MAXIMUM DELAY FOR ACTIVATION OF OCCLUSION ALARM AND BOLUS VOLUME
Occlusion detection
pressure
Infusion rate
set value
Maximum dellay Bolus Volume
P1- : 160kPa 1mL/h 1 hour 25 min 20 sec 1.256mL
25mL/h 2 min 59 sec 1.208mL
P1-2 : 120kPa 1mL/h 1 hour 2 min 34 sec 0.928mL
25mL/h 2 min 12 sec 0.892mL
P1-1 : 80kPa 1mL/h 40 min 20 sec 0.607mL
25mL/h 1 min 26 sec 0.584mL
P1-0 : 40kPa 1mL/h 17 min 34 sec 0.278mL
25mL/h 39 sec 0.268mL

TOP-H series dedicated IV set from TOP, is used
The Maximum delay and bolus volume are influenced by the test conditions.
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Infusion accuracy graph
These are infusion accuracy graphs showing the performance after start of infusion and the variation in
infusion for a short period after normal in fusion rate is reached.
Caution
The infusion accuracy does not reflect such clinical riteria as age and weight of patient and
drugs used.
The infusion accuracy may be influenced by the environment in which the device is used
(pressure, temperature, humidity, IV set used, infusion line, etc.).

Start up curves
Data collected during two hours of
measurment period is plotted

sample intervals t=0.5 min
Test period T=120 min
Infusion rate Q(mt_/h)

Trumpet curves
Flow error in infusion for a short duration (p t)

Observation window duration p t=2,5,11,19,31 min
Maximum measured error in observation window of specified duration, epmax (%)
Maximum measured error in observation window of specified duration, epmix (%)
Overall mean percentage of flow error measured (%)
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Recommeded administration sets
@ use a top-H series dedicated IV set manufactured by TOP corporation.
Otherwise use a tube equipped with a lure lock type connector bearing the CE marking which can assure
connection of other medical equipment.

Caution
@ if a tube equipped with a slip tip connector is used, a loose connection will result.
@ if an IV set other than the TOP-H dedicated IV set is used, infusion may not be performed with the
accuracy given in the spcifications, due to influence of the viscosity and specific gravity of the infusion
solution used.

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Glossary

Symbols
Symbols printed on TOP-3300 main body

Type CF equipment : dgree of protection against electrical shock ; equipment intended for
direct cardiac application.
Alternating current
Direct current
Protection againts liquid ingress.
Equipotential connector : terminal for connection of device to equipotential base of the electric
facility.
Date of manufacture
Continuous adjustment : rotate knob to adjust volume of alarm sound.
Attention, consult accompanying document.
Dispose of using an environmental-friendly method (battery).
Recycling mark (battery).
Device complies with the requirements of EC medical device directive 93/42/EEC 1993/6/14
0123 : notified body : TUV product service