red-eye_intravenous_drip_monitor_sw_8-_02l_user_man.pdf
Page 1
Contents
Instructions for the Red-Eye Ô Intravenous Drip Monitor
[Software version 8.02]
1
2
Introduction………………………………………
2
What is the “Red-Eye Ô Intravenous
Drip Monitor?”….……………………….
Functions of Red-Eye Ô………………….
2
3
How to use the Drip Monitor…………………...
4
Do’s and Do nots…..………………………
Charging the batteries…………………….
Getting to know the indicators, buttons and
connections…………………….…………..
What the Symbols mean on the Device…
Setting up the Drip Monitor……………….
Setting the Drip Monitor…………………..
Parameters of the Drip Monitor..…………
Alarms………………………………….……
Device Set Contents/Accessories………..
3
4
4
5
6
7
8
9
10
11
Care and Maintenance………………………….
12
Cleaning……………………………….…..
Storage……………………………….……
Servicing…………………………….……..
Disposal……………………..………….….
What’s the problem?……………….….….
12
12
13
13
14
4
A Guide to Suitable Applications………………
15
5
Technical and Performance Specification…….
16
6
Addendum: Electromagnetic Compatibility…..
17
Z-9-002/M
Page 1 of 20
Page 2
1: Introduction.
In this manual you will find instructions on how to operate
the Red-Eye Ô Intravenous Drip Monitor safely and
correctly, how to care for it and what to do should anything
go wrong. Please take the time to read all the information
before you use the Drip Monitor and follow any warnings
printed in bold type.
The Drip Monitor is a medical device and has been
carefully designed and made to achieve a high level of
safety protection. In making a decision when to use the
Red-EyeÔ Drip Monitor the performance specification
should be considered along with the treatment being
applied.
Please ensure that this Instruction Manual is given to
the person who will be responsible for using the Drip
Monitor before using the equipment.
What is the Red-Eye Ô Intravenous Drip Monitor
The Red-Eye™ Intravenous Drip Monitor is a battery
operated monitor which displays and records the flow of
fluid from a gravity-feed intravenous drip bag via an
administration set. It is suitable for monitoring blood, blood
products, antibiotics and saline or dextrose based fluids.
The Drip Monitor can also be programmed in advance to
remain in use throughout a series of infusions. A printed
record can be retained for patient records.
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Page 3
Functions of Red-Eye™
Constant monitoring:
The Drip Monitor displays and records the following for
each patient:
Ø
Ø
Ø
Ø
Rate of flow in millilitres per hour
Total fluid delivered (in millilitres)
Time and date
Patient ID Number
Early warning:
The Drip Monitor provides an early warning in the form of
a red light and an optional audible alarm when:
Ø
Ø
Ø
Ø
The flow deviates from the pre-set rate
The required volume of fluid has been
delivered by infusion.
The fluid bag becomes empty.
The flow is interrupted for some other
reason, e.g. the venflon has tissued
Automatic patient records:
Recorded data of each IV infusion can be downloaded
easily to a computer (PC) to complete the patient records.
Simple to operate:
Monitoring of the IV drips is by optical means. The Drip
Monitor calculates fluid flow (ml/h) without the need to use
complicated, time-consuming formulae. Keypads are
“membrane type” to prevent fluids infiltrating into the
equipment and they have a touch sensitive feel for
confident operation.
Z-9-002/M
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Page 4
2: How to use the Drip Monitor.
Do’s and Do Nots
DO
DO
DO NOT
DO NOT
DO NOT
DO NOT
DO NOT
check the battery daily (the icon is updated
on the screen every 15 seconds).
recharge overnight once finished using the
device.
use this device without understanding
these instructions.
get the Drip Monitor wet. It is not
waterproof and the performance will be
affected.
open the Drip Monitor casing to look
inside. The performance will be affected.
use it outside the Drip Monitor’s
temperature range. The performance will
be affected.
bend the sensor lead into an acute angle.
The performance will be affected.
Charging the Batteries.
The batteries are nickel metal hydride cells. The battery icon on the front
screen shows the condition of the batteries. The charger supplied with the
device will recharge to full power in 5 hours. Once fully charged the
device should last 3 to 4 days of constant use.
To charge using the battery charger supplied, plug the charger into the
top socket on the left side of the docking station. (See item 10 Page 5)
Turn on the charger at the electric socket.
WARNING: The Drip Monitor will not run while
charging. Do not plug the charger into the docking
station while the Drip Monitor is in use.
The Drip Monitor will alarm when the battery level becomes low and
requires charging. The alarm is a tone pulse every 30 seconds.
Z-9-002/M
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Page 5
Getting to know the Indicators, Buttons and Connections
Red-Eye™ Display Unit
•
†
ƒ
‚
„
•
‚
ƒ
„
‡
…
†
„ ⑦
Display screen
Top row keys - function keys
Arrow keys to change values
Green (OK) indicator
Red alarm indicator
Power On/Off button
Giving Set Chamber Clip
…
Docking station
⑧ Sensor-lead socket
⑧
⑨ Pole clamp bracket
⑩ Charger socket
⑪ Bag light alarm socket
Z-9-002/M
⑨
Page 5 of 20
⑩
⑪
Page 6
What the Symbols on the Device Mean.
An electrical safety classification in the international
safety standard for medical electrical equipment, type
BF. If the equipment is used as intended there is no
risk of a serious electric shock, but it is not suitable
for direct connection to the heart.
Refer to the accompanying instructions on how to use
the equipment. The instructions are all in this manual.
The CE mark demonstrates that the Drip Monitor
conforms to the requirements in the European Council
Directive 93/42/EEC concerning medical devices. The
number 0123 identifies the Notified Body under
which the Quality Systems operated within Zimed Ltd
are assessed.
Z-9-002/M
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Page 7
Setting Up The Drip Monitor.
The Drip Monitor is a battery operated device. It must be
charged initially, via the mains battery charger, for 5 hours
to ensure maximum operation of the internal battery. (See
Charging the Batteries page 5) The time and date must be
set before using the device. Once charged, the internal
battery will operate for up to 72 hours. Only use the RedEye™ charger supplied.
1. Attach docking
station to drip
stand using the
pole clamp. Use
the thumbscrew to
secure.
2. Clip display unit
onto the docking
station.
3. Insert sensor clip lead into
socket on the
docking station.
•
4. Attach sensor clip
to giving set
chamber and clip
to side.
ƒ
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‚
Page 8
Setting The Drip Monitor.
To Switch “ON” Press the Blue Button
SOLUTION, BLOOD, OR MENU.
v 20 DROPS =1mL SOLUTION,
15 DROPS =1mL BLOOD, OPTIONS =
Parameters of the Monitor
This is the first screen that appears when the
Monitor is turned on.
You must select either “Solution” or “Blood” to
set a desired flow rate:
To change any parameters of the monitor select
the “Menu” button. This will allow you to change
different setting in the monitor.
“First Screen”
GIVING SET
SELECT
SOLUTION BLOOD
MENU
Press “MENU” to change any of the settings on
these screens (See page 9)
TO SET YOUR DESIRED FLOW
RATE IN ml per hour
YOU SET THE FLOW RATE USING
THE ROLLER CLAMP AS NORMAL THIS SCREEN DISPLAYS THE FLOW
RATE IN ml per hour.
ONCE THE SCREEN DISPLAYS
YOUR DESIRED RATE PRESS
“START”. THE VALUE ON THIS
SCREEN IS SAVED AS YOUR “SET
RATE”. PRESS THE “OFF” BUTTON
IF YOU NEED TO RETURN TO THE
START.
Pressing the New infusion button resets
the V.T.B.I (Volume to be infused);
pressing the cont infusion button
continues the V.T.B.I counter.
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Page 8 of 20
SET ROLLER CLAMP
0000 ml / h
OFF
START
Page 9
Parameters of the Monitor.
1-TOTAL VOLUME TO BE INFUSED.
v Required if giving multiple bags or small amounts less than one full bag
v If only giving full single bags ignore
v To change this screen press: the “menu” button once.
“MENU”
v To change the flashing digit press the up or down arrow until the digit is correct. Press the Þ button
to move the flashing digit to the next digit along.
2-ALARM RANGE
v See Graph below, show’s the amount the I-V can deviate before an alarm is given
v To change this screen press: the “menu” button once and then the “next”
button once
“MENU”-“NEXT”
v To change use the up and down arrows (Min value 10%-Max 90%)
3-ALARM DELAY
v Equals the length of time the “Actual Rate” is out of range before it will alarm
v Once set to a value this generally does not need to be changed.
v To change this screen press:: the “menu” button once and then the “next”
button twice
“MENU”-“NEXT” “NEXT”
v To change use the up and down arrows (Min value 10 seconds - Max 90seconds)
4-PATIENT IDENTIFICATION.
v Required if Data logging, if not logging then ignore
v To change this screen to the correct Patient Id, press the “menu” button from the first screen that
appears when the monitor is turned ON, then the “NEXT” button 3 times
“MENU” “NEXT””NEXT””NEXT””
v To change the flashing digit press the up or down arrow until the digit is correct. Press the Þ button
to move the flashing digit to the next digit along.
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Page 10
Monitor is now “SET”
THIS SCREEN DISPLAYS THE “SET
RATE” (TOP OF SCREEN) AND THE
“ACTUAL RATE” (CENTRE OF SCREEN)
THE CURRENT I-V RATE
IF THE “ACTUAL RATE” (CENTRE OF
SCREEN) FALLS OUTSIDE ITS ALARM
RANGE THE BLACK BELL SYMBOL WILL
BE SHOWN.
SET RATE 000
0000
ml/h
MUTE HOME VOL
IF THE BELL SHOWS FOR LONGER THAN
THE SET ALARM DELAY TIME THE DRIP
MONITOR WILL ALARM (See Alarms
below)
“Mute”
TO “MUTE” THE ALARM PRESS THE
BLUE KEY. THE ALARM WILL BE MUTED
FOR 3 MINUTES TO GIVE TIME FOR ANY
CHANGES TO BE MADE ALLOWING THE
“ACTUAL RATE”” TO BE BROUGHT TO
WITHIN RANGE OF THE “SET RATE”.
DISPLAYS THE TOTAL
VOLUME INFUSED, THIS
SCREEN RETURNS TO
THE PREVIOUS SCREEN
AUTOMATICALY
“OFF”
TO SWITCH OFF THE DRIP MONITOR –
PRESS THE “HOME” BUTTON THEN THE
WORD OFF APPEARS ON THE LEFT OF THE
SCREEN. PRESS AND HOLD UNTIL THE
SCREEN TURNS OFF.
Alarms
The main alarm is an audible tone pulsed every 10 seconds. If the flow
rate deviates to outside the alarm range, preset by the operator, (See
“Parameters of the Drip Monitor”), the green light on the front of the
monitor will go out and the red light will illuminate. The display also
reverses from mainly white to mainly black.
For night time use the audible alarm can be turned off and the bag light
plugged in to the docking station (see Getting To Know the Indicators,
Buttons and Connections on page 5). The bag light is clipped on to the
corner tab of the bags of fluid.
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Page 11
Device Set Contents / Accessories.
The Red Eye Intravenous Drip Monitor Device Set comprises of:
Quantity
Description
Part Number
1
Display Unit
Z-3-009/B
1
Docking Station
Z-3-008/A
1
Sensor Lead
Z-6-001/C
1
Mains power charger
Z-3-014/B
1
Operating manual
Z-9-002/L
Bag light
Z-7-001/A
Optional Extras
Z-9-002/M
PC software
Part Number on Request
PC Data download lead
Part Number on Request
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Page 12
3: Care and Maintenance.
When used as described in these instructions the Monitor does not require
any routine maintenance apart from the occasional cleaning.
It is recommended that the performance of the monitor is checked annually.
If the monitor is damaged in any way the performance must always be
checked before it is used again. See Servicing on page 13 for further
information.
Cleaning.
The outside surfaces can be cleaned by wiping with a soft cloth either
dampened with a solution of mild detergent or disinfectant, in water.
Cleaning with organic solvents, e.g. surgical spirit, or abrasive cleaners, may
damage some of the plastic parts.
WARNING:
Risk of change in device performance.
Never dip or immerse the Drip Monitor in any
liquid or try to sterilize it with steam or gas. It is
not completely sealed.
Storage.
If you are going to store the Drip Monitor for some time, isolate the battery by
inserting a paper clip type probe into the hole on the back of the display unit
and press the switch in the hole to turn it off. Store in warm dry place.
When you are ready to start to use the Drip Monitor, repeat the same
process as above and then turn on the Drip Monitor to check the status of
the battery, charge if necessary before use.
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Page 13
Servicing.
Either the Zi-Medical service department must repair the Drip Monitor, or one
of its appointed representatives, or an appropriately trained technician who
has access to the correct technical manuals, service bulletins and approved
replacement parts.
WARNING:
Risk of change in device performance. Always use the
appropriate parts and procedures for repair and
testing as advised by Zi-Medical and published in its
literature.
For after-sales service or advice on how to use the Monitor you can contact
customer services either by telephone, email or by letter, the details are to
be found on back-cover of this manual.
Please have the serial number to hand when you call, which is found on the
label on the reverse of all the units: Display, Docking, and Charger units.
Disposal.
When the time comes to dispose of the Monitor, accessories or packaging
do so in the best way to minimise any negative impact on the environment.
You may be able to use special recycling or disposal schemes. To find out
about these contact your local waste disposal service. Separate any parts of
the equipment where arrangements can be made for their recovery, either by
recycling or energy recovery.
Important: existing national or local regulations concerning waste disposal
must take precedence over the above advice.
Z-9-002/M
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Page 14
What’s the problem?
If the Drip Monitor does not perform as expected, if it is dropped, gets wet or
is damaged in any way, then remove it from use immediately. Label it clearly
as quarantined and preferably take it out of the working area, to ensure it
cannot be used accidentally until it has been checked.
The Drip Monitor must be carefully inspected for damage inside and its
performance checked to the specification. A properly trained technician must
complete these tests.
WARNING:
Risk of change in device performance. If the Drip Monitor gets wet
do not just dry the outside and then continue to use - liquid may
be inside and could have caused damage. Follow the advice
given above
Helpful Hints.
1 Re charge overnight.
2 When clamped on drip stand, try to angle back to enable clear
view of screen.
3 Fit drip sensor clip about 1 to 2mm from the top of the giving set.
4 Ensure that the giving set is vertical.
5 If not vertical, rotate the sensor clip until drip detection is made in
the giving set screen.
Monitor stopped working.
A If the Sensor Fault message appears on starting the Drip Monitor check
the following:
Is the sensor lead connected?/Plugged in to the socket correctly?
Is the sensor too low on the giving set and the beam below the water
level?
Is the sensor too high and the beam being broken by the giving set
pipette?
Is there condensation or any splashes in the giving set chamber?
Is the Drip Monitor in very bright daylight?
Is the battery low in the Drip Monitor?
B If the green light is not flashing when using roller clamp screen, see points
2 to 4 above.
C If the green light ceases to “blink” when the drip passes the sensor,
ensure the clip position is such that the beam is broken by the drip.
Z-9-002/M
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Page 15
4: A Guide to Suitable Applications.
The Red-Eye™ IV Drip Monitor is intended to be used in combination with an
intravenous drip, i.e. .an administration set and an IV fluid bag.
Intravenous drips are used to deliver blood, blood products, antibiotics,
and saline or dextrose based products.
The Drip Monitor functions by calculating flow rate (ml per hour), via a fibre
optic cable connected to a flexi-clip fitted to the administration set of the IV
apparatus.
There are two broad categories of administration sets, which the Drip Monitor
is compatible for use with:
v Blood Administration sets: - calibrated to deliver 15 drops per ml of
blood.
v Solution Administration sets: - calibrated to deliver 20 drops per ml of
H2O. These sets are suitable for all saline/dextrose-based products.
MINIMUM DIAMETER:
17 mm
of administration set
MAXIMUM DIAMETER:
24 mm
of administration set
MINIMUM DIAMETER:
12 mm
of drip stand
MAXIMUM DIAMETER:
30 mm
of drip stand
Please refer to the individual manufacturer of administration sets for
advice regarding administration of drugs / fluids not easily categorised
into blood or saline type fluid.
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Page 16
5: Technical and Performance Specification.
Administration set
15 or 20 drops/ml
Measurement range
10 to 1000 ml/hour
Alarm range
10 to 90% in steps of 10%
Alarm delay
10 seconds to 90 seconds in steps of 10 seconds
Mute delay
3 minutes
Pre-set volume to infuse
0 to 9999 ml in steps of 1 ml
Total measurement
9999 ml manually re-set
Accuracy:
±20% (H2O at room temperature)
Operating time
At least 72 hours continuous from full charge
Recharge time
5 hours maximum
Time
Displayed continually when in use
Date and time
Recorded at start of administration
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Page 17
6: Addendum, Electromagnetic Compatability
This addendum to the Red Eye ™ User Manual provides information required by EN60601-1-2:2001. It
describes the Standards to which the Red Eye ™ was tested and approved, the minimum test level
identified in the Standard, and general guidance on management of the EMC environment in which the Red
Eye ™ may be safely used.
Precautions should be taken to avoid exposing the Red Eye ™ to powerful sources of electromagnetic
radiation such as MRI (magnetic resonance imaging) and ESU (electrosurgical equipment).
Note also that portable and mobile communications equipment such as cell phones can adversely affect
medical electrical equipment.
The Red Eye ™ drip monitor is intended to be used in conjunction with other equipment, forming a “system”.
Correct operation of all elements of the “system” must be verified before use.
Table 1: Guidance and Manufacturers Declaration - Electromagnetic Emissions
The drip monitor is intended for use in the electromagnetic environment specified below. The customer or
the user of the drip monitor should assure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic environment - Guidance
RF emissions
CISPR 11
Group 1
The drip monitor uses RF energy only for its internal function.
Therefore, its emissions are very low and are not likely to
cause any interference in nearby electronic equipment
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Not applicable
The drip monitor is suitable for use in all establishments
other than domestic and those connected to the public low
voltage power supply network that supplies buildings used
for domestic purposes.
Table 2: Guidance and Manufacturers Declaration - Electromagnetic Immunity
The drip monitor is intended for use in the electromagnetic environment specified below. The customer or
the user of the drip monitor should assure that it is used in such an environment.
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Z-9-002/M
IEC 60601
Test level
Compliance
level
+/- 6kV contact
+/- 6kV contact
+// 8kV air
+/- 8kV air
Page 17 of 20
Electromagnetic environment Guidance
Floors should be wood, concrete or
ceramic tile. If the floors are covered
with synthetic material, the relative
humidity should be at least 30%.
The drip monitor rate display may clear
to zero at levels above 8kV air. Do not
touch the connector pins directly. The
connector is marked with the symbol for
ESD sensitivity (ref. IEC 60417-5134)
Page 18
Electrical fast
transient burst
IEC 61000-4-4
+/- 2kV for power
supply lines
+/- 1kV for input/
output lines
Not applicable
Surge
IEC 6100-4-5
+/- 1kV differential
mode
+/- 2kV common
mode
Not applicable
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip
in UT) for 5 cycles
70% UT (30% dip
in UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
Not applicable
3 A/m
3 A/m
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60Hz) magnetic
field
IEC 61000-4-8
Not applicable
Not applicable
Not applicable
Not applicable
Mains power quality should be that of a
typical commercial or hospital
environment.
The drip monitor is not functional while
mains power is connected for charging
the battery.
Mains power quality should be that of a
typical commercial or hospital
environment.
The drip monitor is not functional while
mains power is connected for charging
the battery.
Mains power quality should be that of a
typical commercial or hospital
environment.
The drip monitor is not functional while
mains power is connected for charging
the battery.
Not applicable
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Table 3: Guidance and Manufacturers Declaration - Electromagnetic Immunity - for
equipment and systems that are Life-Supporting
The drip monitor is intended for use in the electromagnetic environment specified below. The customer
or the user of the drip monitor should assure that it is used in such an environment.
Immunity
Test
IEC 60601
Test level
Compliance
level
Electromagnetic environment Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the drip monitor, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to 80MHz
outside ISM bands
Not applicable,
ref. EN60601-12:2001 clause
36.202.6 a)5
d=1.17√P
10 Vrms
150kHz to 80MHz
in ISM bands a
Not applicable,
ref. EN60601-12:2001 clause
36.202.6 a)5
d=4√P
a
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Page 19
Radiated RF
IEC 61000-4-3
10 V/m
80MHZ to 2.5GHz
3 V/m (3)
d=4√P 80 MHz to 800 MHz
d=7.67√P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m) b.
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
c
survey, should be less than the
d
compliance level in each frequency range .
Interference may occur in the vicinity of
equipment marked with the following
symbol:
10 V/m (3)
The drip monitor may not operate correctly
above 3 V/m. (3)
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.
Note 3
The drip monitor was designed to meet EN60601-1-2:1993
The ISM (industrial, scientific and medical) bands between 150kHz and 80 MHz are
6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz,
and 40.66 MHz to 40.7 MHz.
a
The compliance level in the ISM frequency bands between 150 kHz and 80 MHz and
in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood
that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is
used in calculating the recommended separation distance for transmitters in these
frequency ranges.
b
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 drip monitor is used exceeds the applicable RF compliance
level above, the drip monitor should be observed to verify normal operation. If
abnormal operation is observed, additional measures may be necessary, such as
reorienting or relocating the drip monitor.
c
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
d
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Page 20
Table 4: Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the Drip Monitor - for Life Supporting
Equipment and Systems
The drip monitor is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the drip monitor can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the drip monitor as recommended below, according to
the maximum output power of the communications equipment.
Separation Distance according to Frequency of Transmitter (m)
Rated maximum
output power of
Transmitter (W)
150 kHz to 80
MHz outside ISM
bands
d=1.17√P
150 kHz to 80
MHz in ISM bands
d=4√P
80 MHz to 800
MHz
d=4√P
800 MHz to 2.5
GHz
d=4√P
0.01
0.12
0.4
0.4
0.77
0.1
0.37
1.26
1.26
2.42
1
1.17
4
4
7.67
10
3.7
12.65
12.65
24.24
100
11.7
40
40
76.67
For transmitters rated at a maximum power output 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 80 MHz and 800 MHz, the separation distance of the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150kHz and 80 MHz are 6.765 MHz
to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz, and 40.66 MHz to
40.7 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Z-9-002/M
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