SurgiCube® Air Handling Apparatus Service Manual

SurgiCube®
Air Handling Apparatus
Service Manual
Model: EB1
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SurgiCube Service Manual – Model EB1
Version: 1.0
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Contents
1
Company information ......................................................................................................... 3
2
Safety information .............................................................................................................. 4
2.1
3
Please read this first..................................................................................................... 4
Service of the SurgiCube® ................................................................................................. 6
3.1
Overall visual inspection ............................................................................................. 7
3.2
Corrective actions:....................................................................................................... 8
3.3
Pre-filter exchange ...................................................................................................... 9
3.4
Pre Filter Installation Instructions for SurgiCube® .................................................. 10
3.5
HEPA-filter exchange ............................................................................................... 12
4
Air velocity settings .......................................................................................................... 15
5
Validation ......................................................................................................................... 16
6
Reporting .......................................................................................................................... 17
7
Annex 1: Validation Report .............................................................................................. 17
8
Annex 2: Maintenance and service report ........................................................................ 21
9
Annex 3 Complaint / Service request ............................................................................... 22
10
Annex 4: Electrical Diagram ........................................................................................ 23
11
Annex 5: EMC guidance and manufacturer’s declaration ............................................ 24
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1
Company information
SurgiCube International BV
Seggelant-Noord 4
3237MG VIERPOLDERS
The Netherlands
Phone: +31181760600
E-mail: support@surgicube.com
Website:
www.surgicube.com
SurgiCube® bears the
marking and complies with the provisions of the
Medical Device Directive 93/42 EEC.
SurgiCube International BV takes no responsibility for use of the product other than for
those uses specified herein and disclaims any liability resulting from other uses.
Observe all warnings and precautions.
Copyright 2017, SurgiCube International BV.
All rights reserved.
This manual reflects SurgiCube® model SC100, SC180, SC200 and SC220 Type EB1
Manual; revision 1.0 February 2017
SurgiCube International BV
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2
Safety information
This manual uses different safety alert symbols. The symbols are inserted in the left
hand margin with a subsequent explanatory text. Please observe that there are
warnings and cautions inserted throughout the manual. They appear where it is most
suitable in respect to where a potential risk may be encountered. The meaning of
these symbols is explained in the following table:
Symbol
Meaning
This symbol indicates a dangerous situation that could lead to death
or serious injury if not avoided.
Warning
This symbol indicates that care should be taken to prevent damage
to the unit and/or poor performance.
Caution
!
2.1
This symbol provides the operator with helpful hints and messages.
Please read this first
Warning
Never insert objects through holes or openings in the SurgiCube®.
Doing so may damage the SurgiCube®, compromise its function
and/or pose a hazard to the operator and/or the patient.
Never open or remove a cover of the SurgiCube® without consulting
SurgiCube International BV. Unauthorized opening of the SurgiCube®
is hazardous because of exposure to moving and/or electrically
charged elements. Unauthorized opening of the SurgiCube® may
permanently contaminate and/or damage elements.
Never use the SurgiCube® if the SurgiCube® or parts of the
SurgiCube® are damaged, displaced or dysfunctional/suspected to be
dysfunctional. Never use the SurgiCube® if the HEPA filter above the
surgical field is damaged, displaced or dysfunctional.
Do not add and/or remove elements and/or components of the
SurgiCube® prior written permission from SurgiCube International
BV.
Do not drill holes in the SurgiCube® without consulting SurgiCube
International BV.
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Before opening the SurgiCube® it is important to switch it off prior to any type of
service, maintenance or corrective action. Please switch off the on/off button at the
front of the right column. After switching the SurgiCube® off, please unplug the
SurgiCube® by removing the plug from the electrical socket.
On/Off switch (green LED) - On/Off button for LED lights (white LED)
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3
Service of the SurgiCube®
It is recommended that service, maintenance and inspection are carried out frequently by a
trained technician. The recommended maintenance schedule is based on periods of two
years with six month intervals and exists of preventive actions in order to guarantee the
best performance. When a new SurgiCube® is installed, it will have new pre-filters and a
new HEPA-filter and it will have to be validated prior to use (please use the ‘Validation
Report’ as provided at the installation). Six months later the first preventive maintenance
shall be scheduled.
Recommended preventive maintenance scheme:
01-01-20xx
+ 6 months
+ 12 months
+ 18 months
+ 24 months
+ 6 months
+ 12 months
+ 18 months
+ 24 months
And so on
Installation date, validation of the unit
Overall visual inspection, pre-filter exchange, report
Overall visual inspection, pre-filter exchange, validation, reports
Overall visual inspection, pre-filter exchange, report
HEPA and pre-filter exchange, overall visual inspection, validation, reports
Overall visual inspection, pre-filter exchange, report
Overall visual inspection, pre-filter exchange, validation, reports
Overall visual inspection, pre-filter exchange, report
Overall visual inspection, HEPA and pre-filter exchange, validation, reports
It is recommended to change the HEPA-filter every two years. Based on that frequency the
preventive maintenance scheme can be repeated for every two years.
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3.1
Overall visual inspection
Just before preventive maintenance and the exchange of the pre-filters an overall visual
inspection of the SurgiCube shall be done. Visual inspection of the following is
recommended:
DURING THE FIRST PART OF THE OVERALL VISUAL INSPECTION THE POWER
SHALL BE ON
The full metal and glass construction
HEPA filter
LED lights
Cables / wires
Labeling
Is it undamaged and clean?
Is it undamaged and clean?
All are working correct?
All undamaged and clean?
All labels visual and undamaged?
BEFORE THE SECOND PART OF THE INSPECTION THE POWER MUST BE SWITCHED OFF
For the second part of the overall visual inspection, the front panels must be removed, by
using an Allen key:
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Store the front panels upright against the wall. Make sure that they cannot fall over and / or
damage the SurgiCube® or the surrounding environment. Keep the screws and the Allen key
near the stored front panels.
Now the SurgiCube® is open, the second part of the overall inspection can take place:
The internal construction
Screws and bolts
Cables / wires
Is it undamaged and clean?
All present and secured?
All undamaged and tidy?
If necessary corrective actions shall be done.
3.2
Corrective actions:
Damaged metal and glass construction
HEPA filter damaged
LED light(s) defect
Cables / wires damaged or dirty
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Determine safety of the unit for use by
staff and use with patients; if any risks
do immediately contact SurgiCube
International or your local representative.
Broken parts need to be replaced prior to
use.
Do a particle test and determine air
velocity. Next, arrange for a validation
and check filter integrity prior to use.
Replace the defect LED(s) by new ones;
or exchange the whole set including
wiring for a new one. Does not
necessarily need to be done prior to use.
If dirty (dust) just clean by using a
vacuum cleaner and a cloth. If damaged:
contact SurgiCube International or your
local representative. Broken parts need
to be replaced prior to use.
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Labeling damaged, missing or missing
information
The internal construction is dirty or corrosive
Screws or bolts not secured
Replace missing or damaged labeling or
resolve by checking validation dates,
maintenance dates and correct it.
Clean by removing dust with a vacuum
cleaner and a cloth; if corrosion is found,
contact SurgiCube International or your
local representative. Affected parts need
to be cleaned prior to use.
Secure or replace them prior to use.
If in doubt, please contact SurgiCube International or your local representative, and present
detailed information, if possible with photos, to clarify your request for assistance.
3.3
Pre-filter exchange
The SurgiCube® has two sets of pre-filters in each column. The pre-filters have the following
filtering classes:
1. G3 frame filter
2. F7 cassette filter
You can order your pre-filter sets from SurgiCube International or your local representative.
Please follow the instructions for the exchange of the filters based on the six month interval.
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3.4
Pre Filter Installation Instructions for SurgiCube®
1: Remove front panel
3: Position Cassette Filter in opening
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2: Remove filters and clean frame
4: Make sure it fits equally
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5: Position Frame Filter
8: Position pin in top and bottom holes
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6: Fit in front of Cassette Filter
9: Close front panel
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3.5
HEPA-filter exchange
Since the HEPA-filter must be treated with care and due to the length and weight of it, it is
recommended that the trained technician has an assistant available.
Items needed:
1.
2.
3.
4.
New HEPA-filter in correct size
Spare filter in correct size
Set of tools (Allen keys, screwdrivers, knife, sealant injector)
Degreaser, VHB cleaner, primer, sealant
Every HEPA-filter has a unique serial number and comes with a certificate. Please send a
copy of the HEPA-filter that is installed to SurgiCube International or to your local
representative.
Example of the HEPA-certificate
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CHECK IF THE NEW HEPA-FILTER IS UNDAMAGED BEFORE REMOVING THE
EXISTING FILTER
In order to remove the existing HEPA-filter, one carefully needs to cut all the sealant that
holds the existing HEPA-filter.
DO NOT DAMAGE THE SURGICUBE® PANELS WITH THE KNIFE
Once all the sealant has been cut, remove the screws that secure the HEPA-filter by using
an Allen key.
When the screws are removed, one needs to hold the HEPA-filter with two persons, and
carefully lower it in a straight way, not damaging or scratching the inner sides of the panels.
DO NOT DAMAGE THE SURGICUBE® PANELS WITH THE HEPA-FILTER FRAME
Pack the HEPA-filter in plastic foil and store it away from your working space. If you use a
special transport crate or flight case, store it in there.
Remove all the sealant from the HEPA-filter mounting frame and the side panels. Clean your
working area. Use the degreaser to remove all adhesives. Use the VHB cleaner and let it dry
for 10 minutes. You can now unpack the HEPA-filter. Put it on the crate or flight case and
clean the frame with VHB cleaner. Let it dry for 10 minutes.
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DO NOT SPILL OR USE THE VHB CLEANER ON THE HEPA-FILTER MEDIA OR
THE GEL SEAL
Next one needs to apply the primer to the HEPA-filter frame and the HEPA-filter mounting
frame. Let it dry for 30 minutes.
The HEPA-filter used for the SurgiCube® has a
Fluid Seal Gel that fits the HEPA-filter mounting
frame. This seals the HEPA-filter 100% in its
mounting. This side is faced up towards the
mounting frame.
Carefully position the HEPA-filter into the
mounting frame with two persons. Do not scratch or
damage the inner sides of the panels.
Once the HEPA-filter is positioned in the mounting
frame, one needs to put in the screws on both sides
and secure the HEPA-filter.
After securing the HEPA-filter with screws one have to clean the sealant area with the VHB
cleaner and let it dry for 10 minutes. Then apply the primer and let it dry for 30 minutes. Next
it needs to be sealed with sealant.
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MAKE SURE TO FULLY SEAL ALL SEAMS AND GAPS WITH THE SEALANT
LET THE SEALANT DRY FOR 24 HOURS
4
Air velocity settings
The air velocity is set at the time of installation and needs a yearly validation. The standard
air velocity is set to an average of 0.45m/s.
For determination of the air velocity or to set it, one needs to have an air velocity meter. A
deviation of +/- 10% is allowed so average measurements between 0.40m/s and 0.50m/s
are accepted.
To change the air velocity follow the next steps:
1. Remove the lower front panel of the right column (use an Allen key)
2. Pull the electronics box towards you
DO NOT OPEN THE ELECTRONICS BOX SINCE THE POWER IS STILL ON!
3. Adjust the button in the middle of the back side of the electronics box by turning it to
the right or left, depending the need for faster or slower air velocity
4. Measure the air velocity
5. Repeat steps 3-4 until you manage to set the air velocity correctly
6. Push the electronics box back in the column
7. Close the front panel by using the Allen key
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MAKE SURE TO MOUNT THE FRONT PANEL ONCE DONE
5
Validation
MAKE SURE TO HAVE THE SURGICUBE® VALIDATED EVERY YEAR
Validation of the SurgiCube® is done at installation. It is highly recommended to repeat the
validation every year. In some occasions another validation is recommended:
•
•
•
•
•
After HEPA-filter exchange
In the occasion of an event that compromises the filter(s) in any way
When putting the SurgiCube® out of order / out of use
When doubting the effectivity in any way
When an infection had occurred
SURGICUBE INTERNATIONAL RECOMMENDS CONTRACTING A THIRD PARTY
FOR VALIDATIONS
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6
Reporting
In the event of preventive or corrective maintenance, service, inspection and validation a
report needs to be generated. Examples are found in the annexes and they are available
upon request.
7
Annex 1: Validation Report
VALIDATION REPORT
Serial-nr
Installation date
Validation date
PLEASE NOTE:
Photo of the SurgiCube® in situ
Make sure that the SurgiCube® is switched
on for at least 30 minutes.
The correct size sterile SurgiCube® drape
must be applied according to the
instructions.
Distributor name
Address 1
Address 2
Postcode, City
Country
Phone
E-mail
Responsible contact
Signature
Customer name
Address 1
Address 2
Department
Floor, room number
Postcode, City
Country
Phone
Validation company
Address 1
Address 2
Postcode, City
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Country
Phone
E-mail
Type of validation
 New Installation
Annual Validation
 Other, please specify:
 New HEPA filter validation
Post-Event Validation
The following passed tests results are required for release of the SurgiCube®:
Test
Criterium
Result
Filter Integrity Test
Air Velocity Test
Particle Concentration
in the clean area
≤0,01% leakage
0,45m/s ±10% deviation
ISO 5 ≤3520 particles of
0,5µm/m³
 Pass
 Pass
 Pass
Height: 90cm at instrument table
Depth: 80cm perpendicular to HEPA filter
Copy of original measurement report(s) attached?
Copy of calibration reports equipment used attached?
Copy of HEPA H14 test certificate attached?
Validation sticker / label attached on SurgiCube®?
Height: ±90cm at instrument table
Depth: 80cm perpendicular to HEPA filter
 Yes
 Yes
 Yes
 Yes
 No
 No
 No
 No
Remarks /
Notes
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 Fail
 Fail
 Fail
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Additional tests depending local regulations and requirements:
Colony Forming Units
in the clean area
Colony Forming Units
in the periphery
≤5 CFU’s per m³
 Pass
 Fail
Reference points outside the clean
area for comparison
 Yes
 No
 Yes
 Yes
 Yes
Lab results attached
Photos of agar plates / strips attached
Calibration reports equipment used attached
 No
 No
 No
Remarks /
Notes
Additional tests depending local regulations and requirements:
Test / info
Remarks / notes
Pressure hierarchy /
Air Changes
 Yes
 No
Particle Concentration
in the periphery
 Yes
 No
Protection Degree
of the clean area
 Yes
 No
Recovery time
of the clean area
 Yes
 No
Temperature
 Yes
 No
Relative humidity
 Yes
 No
Sound level (dBA)
 Yes
 No
Remarks /
Notes
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You can send this report to:
SurgiCube International BV
Seggelant-Noord 4
3237 MG Vierpolders
The Netherlands
E-mail: support@surgicube.com
If you have any additional questions, or in case you need more specific information, please
contact us by e-mail (support@surgicube.com) or by phone (+31 181 760 600).
Responsible person:
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Sign:
Date:
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8
Annex 2: Maintenance and service report
Maintenance and service report SurgiCube®
Customer
Contact
Address
City
Phone
Type SC
Serial number
Location
Date
Contract
Subject
Checked
Prefilter 1
Prefilter 2
HEPA-filter
Fan
LED(s)
Electronics
Visual Inspection
 Yes
 Yes
 Yes
 Yes
 Yes
 Yes
 Yes
Replaced
 No
 No
 No
 No
 No
 No
 No
 Yes
 Yes
 Yes
 Yes
 Yes
 Yes
 Yes
Remarks
 No
 No
 No
 No
 No
 No
 No
Remarks:
Service Engineer on-site
Name:
Signature:
Customer on-site:
Name:
Signature:
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SurgiCube International B.V.
Seggelant-Noord 4
3237 MG Vierpolders
The Netherlands
Tel: +31 181 760 600
E-mail: support@surgicube.com
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9
Annex 3 Complaint / Service request
Your ref number
Distributor/Customer
Date:
Device:
Phone:
Serial no:
Complaint:
Service request:
Other:
Has there been a serious injury or death associated with this device?
No
Yes. Describe relationship to incident or event:
Please forward this form to:
SurgiCube International BV
Seggelant-Noord 4
3237 MG Vierpolders
The Netherlands
Ph: + 31 (0) 181 760 600
Internet: www.surgicube.com
E-mail: info@surgicube.com
FOR SURGICUBE INTERNATIONAL BV
Received by:
Date:
MIF no:
Result/Action:
Complaint:
Closed:
Repair:
Modified:
Not closed:
Responsible person:
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Maintenance:
Validation:
Service contract:
Reason:
Sign:
Date:
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Other:
10 Annex 4: Electrical Diagram
Electrical Diagram Electronics Box 1
Located in the front drawer in the right column
Electrical Diagram Electronics Box 2
Located in the top middle part behind the service panel
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11 Annex 5: EMC guidance and manufacturer’s declaration
Guidance and manufacturer's declaration - electromagnetic emissions
The SurgiCube® is intended for use in the electromagnetic environment specified below. The
customer or the user of the SurgiCube® should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
The SurgiCube® uses RF energy only for its internal
RF emissions
function. Therefore, its RF emissions are very low and
Group 1
CISPR 11
are not likely to cause any interference in nearby
electronic equipment.
RF emissions
Class B
CISPR 11
Harmonic
The SurgiCube® is suitable for use in all establishments,
including domestic establishments and those directly
emissions
Class A
connected to the public low-voltage power supply
IEC 61000-3-2
network that supplies buildings used for domestic
Voltage
purposes.
fluctuations /
Complies
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The SurgiCube® is intended for use in the electromagnetic environment specified below. The
customer or the user of the SurgiCube® should assure that it is used in such an environment.
IEC 60601 test
Electromagnetic environment Immunity test
Compliance level
level
guidance
Electrostatic
±2, 4 and 6 kV
±8 kV contact
Floors should be wood, concrete or
discharge
contact
±15 kV air
ceramic tile. If floors are covered
(ESD)
with synthetic material, the relative
±2, 4 and 8 kV air
IEC 61000-4-2
humidity should be at least 30 %.
Electrical fast
±2 kV for power
±2 kV for power
Mains power quality should be that
transient/burst supply lines
supply lines
of a typical commercial or hospital
IEC 61000-4-4
environment.
Surge
±1 kV differential
±1 kV differential
IEC 61000-4-5 mode (line-to-line)
mode (line-to-line) Mains power quality should be that
of a typical commercial or hospital
±2 kV common
±2 kV common
environment.
mode (line-tomode (line-toearth)
earth)
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Guidance and manufacturer's declaration - electromagnetic immunity
The SurgiCube® is intended for use in the electromagnetic environment specified below. The
customer or the user of the SurgiCube® should assure that it is used in such an environment.
IEC 60601 test
Electromagnetic environment Immunity test
Compliance level
level
guidance
Voltage dips,
<0 % U T
<0 % U T
short
(>95 % dip in U T )
(>95 % dip in U T )
interruptions
for 0,5 cycle
for 0,5 cycle
and voltage
U
(10msec)
variations on
40 % T
power supply
Mains power quality should be that
40 % U T
(60 % dip in U T )
input lines
of a typical commercial or hospital
(60 % dip in U T )
for 5 cycles
IEC 61000-4environment. If the user of the
for 5 cycles
70 % U T
11
SurgiCube® requires continued
(100msec)
U
operation during power mains
T
(30 % dip in
)
UT
70
%
interruptions, it is recommended
for 25 cycles
U
that the SurgiCube® be powered
(30 % dip in T )
<0 % U T
from an UPS or a battery.
for 25 cycles
(>95 % dip in U T )
(500msec)
for 5 sec
<0 % U T
(>95 % dip in U T )
for 5 sec
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE U T is the a.c. mains voltage prior to application of the test level.
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Guidance and manufacturer's declaration - electromagnetic immunity
The SurgiCube® is intended for use in the electromagnetic environment specified below. The
customer or the user of the SurgiCube® should assure that it is used in such an environment.
Immunity
IEC 60601
Compliance
Electromagnetic environment test
test level
level
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the SurgiCube®, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted
RF
IEC 61000-46
Radiated RF
IEC 61000-43
3 Vrms
150 KHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
10 Vrms
10 V/m
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).
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.b
Interference may occur in the vicinity of
equipment
marked with the following symbol:
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.
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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 SurgiCube® is used exceeds the
applicable RF compliance level above, the SurgiCube® should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orientating or relocating the SurgiCube®.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended minimal separation distances between portable and mobile RF
communications equipment and the SurgiCube® (Not Life supporting: V1 = 10V & E1 =
10V/m)
The SurgiCube® is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SurgiCube® can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the SurgiCube® as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
Separation distance d according to frequency of transmitter in
output power of
meters
transmitter
W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5
GHz
3,5
d =[ ] P
3, 5
7
E1
d =[ ] P
d =[
V1
0.01
0.1
1
10
100
0.04
0.11
0.35
1.11
3.50
0.04
0.11
0.35
1.11
3.50
E1
0.07
0.22
0.70
2.21
7.00
It is recommended to perform an electrical safety test after installation and
commissioning of the SurgiCube®.
27/27
Service
SurgiCube Service Manual – Model EB1
Version: 1.0
surgicube.com
] P
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