Stryker Endoscopy Arthroscopy Pump Standard User manual
GENERAL
INFORMATION
Read
this
manual
Please
familiarize
yourself
with
the
contents
of
this
manual
before
using
the
device.
Failure
to
follow
these
instructions
may
result
in
injuries
to
both
the
patient
and
the
user.
Medical
accessories
and
devices
may
be
used
only
by
physicians
or
medical
assistants
under
the
direc¬
tion
of
a
physician
with
the
appropriate
technical
quali¬
fication.
Please
read
this
manual
completely
and
follow
its
in¬
structions
carefully.
The
words
WARNING,
CAUTION
and
NOTE
carry
special
meanings
and
they
should
be
read
attentively.
WARNING
!
The
personal
safety
of
the
patient
may
be
involved.
Dis¬
regarding
this
information
could
result
in
injury
to
the
patient.
CAUTION
!
These
instructions
point
out
special
service
procedures
or
precautions
that
must
be
followed
to
avoid
damaging
the
device.
NOTE
!
This
provides
special
information
that
facilitates
mainte¬
nance
or
clarifies
important
instructions.
Please
pay
particular
attention
to
the
chapters
Safety
Instructions
and
Purpose
of
the
Device.
Who
should
use
the
manual
?
The
manual
is
addressed
to
physicians
or
medical
assist¬
ants
with
an
appropriate
qualification.
These
persons
are
authorized
to
operate
this
device.
The
structure
of
the
manual
The
large
titles
in
the
header
will
help
you
locate
the
chapters
quickly.
There
is
a
list
of
error
messages
and
warning
indications
at
the
end
of
the
manual
that
assist
in
troubleshooting
problems.
Refer
to
the
illustrations
on
the
rear
cover
of
the
manual.
E-2
CONTENTS
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Safety
Instructions.
1-
1
Warnings...
Purpose
of
the
Device.
2-
1
Cautions.
Initial
Use
of
the
Device.
Operating
the
Device.
4-1
Front
of
the
Device.
4-2
Rear
of
the
Device...
4-3
Inserting
the
Tubing
Set.
4-4
Turning
the
Device
on.
4-5
Start/Stop
Key.
4-6
Automatic
Instrument
Recognition.].
4-7
Preselecting
the
Desired
Pressure..
4-8
Preselecting
the
Desired
Flow.
4-9
Program
Keys.
4-10
Actual
Pressure
Display.
4-11
Warning
Displays.
4-12
RS232-Serial
Port
(Option).
Safety
Functions..
User
Menu.
Options.
7-1
Cable
Remote
Control.
7-2
Footpedal.
Function
Test.
Use
of
the
Device
During
Operation.
Service
and
Maintenance.
10-1
Cleaning
the
Device.
10-2
Cleaning
of
the
Reusable
Silicone
Tubing
Set
(not
for
USA).
10-3
Disinfection
of
the
Reusable
Silicone
Tubing
Set
(not
for
USA)
10-4
Sterilization
of
Reusable
Silicone
Tubing
Set
(not
for
USA).
10-5
Sterilization
Conditions
(not
for
USA).
10-6
Cleaning
the
autoclavable
remote
control.
10-7
Sterilising
the
autoclavable
remote
control.
10-8
Sterilisation
conditions
for
the
autoclavable
remote
control....
10-9
Annual
Inspection.
10-10
Maintenance
by
the
Authorized
Service
Technician.
10-
11
Replacing
the
Fuse.
Annual
Inspection...
11-
1
Safety
Test.
11-2
Basic
Function
Test.
11-3
Testing
the
Measurement
of
Pressure.
11-4
Test
of
the
Pressure
Sensors.
Test
Record.
Technical
Data.
Index
.
Troubleshooting
Instructions.
.4
.4
.5
.5
.6
.7
.7
.7
.7
.7
.7
.8
.8
.8
.......
8
.9
.9
.9
.9
.10
.11
.11
.11
.11
.12
.13
.13
.13
.13
.13
.14
.14
.14
.14
.14
.14
.15
.15
.15
.15
....16
....16
....17
.18
....19
...20
E-3
1
SAFETY
INSTRUCTIONS
1
SAFETY
INSTRUCTIONS
Please
familiarize
yourself
with
the
safety
instructions
before
using
the
device!
Federal
law
(only
U.5.A.)
Federal
Law
(US.A.)
restricts
this
device
to
use
by
or
on
the
order
of
a
physician.
Warranty
The
manufacturer
warrants
that
the
device
and
the
ac¬
cessories
will
be
free
from
manufacturing
and
material
defects
for
one
year
from
date
of
purchase.
This
war¬
ranty
is
limited
to
the
terms
and
conditions
described
herein,
and
there
are
no
other
warranties,
expressed
or
implied.
No
liability
The
manufacturer
is
not
liable
for
direct
or
resulting
damage,
and
the
warranty
becomes
void
if:
•
the
device
or
the
accessories
are
improperly
used;
•
the
instructions
and
rules
in
the
manual
are
not
ad¬
hered
to;
•
the
device
or
the
accessories
are
improperly
pre¬
pared
or
maintenanced;
•
non-authorized
persons
perform
repairs,
adjust¬
ments
or
alterations
on
the
device
or
accessories;
the
prescribed
inspection
and
maintenance
sched¬
ule
is
not
adhered
to.
Receipt
of
technical
documentation
from
the
manufac¬
turer
does
not
authorize
individuals
to
perform
repairs,
adjustments
or
alterations
on
the
device
or
accessories.
Authorized
service
technician
Only
an
authorized
service
technician
may
perform
re¬
pairs,
adjustments
or
alterations
on
the
device
or
acces¬
sories.
The
manufacturer
has
the
exclusive
right
to
train
and
certify
authorized
service
technicians.
Care
and
maintenance
To
guarantee
safe
operation,
it
is
absolutely
necessary
to
carry
out
proper
care
and
maintenance
of
the
device
and
accessories.
For
the
protection
of
the
patient
and
the
operating
team,
check
that
the
device
is
complete
and
functional
before
each
use.
Brand-new
products,
as
well
as
repaired
products,
must
be
prepared
and
tested
according
to
the
manual
instruc¬
tions
prior
to
use.
Contamination
For
the
protection
of
the
service
personnel,
and
for
safety
during
transportation,
all
devices
and
accessory
parts
that
are
sent
in
to
be
repaired
must
be
prepared
for
shipment
as
described
in
the
manual.
If
this
is
not
possible,
the
product
must
be
clearly
marked
with
a
con¬
tamination
warning
and
should
be
double-sealed
in
safety
foil.
The
manufacturer
has
the
right
to
refuse
to
carry
out
re¬
pairs
if
the
product
is
contaminated.
Waste
Management
Follow
the
national
waste
Management
rules.
Water
hazard
Protect
the
device
from
being
splashed
by
water.
Keep
the
power
switch
dry.
Should
any
liquid
enter
the
device,
discontinue
use
immediately.
Original
accessories
For
your
own
safety,
and
that
of
your
patient,
use
only
original
accessories.
Specific
technique
and
procedure
Only
the
physician
can
evaluate
the
clinical
factors
in¬
volved
with
each
patient
and
determine
if
the
use
of
this
device
is
indicated.
The
physician
must
determine
the
specific
technique
and
procedure
that
will
accomplish
the
desired
clinical
effect.
r
Available
voltage
Determine
if
the
available
voltage
corresponds
to
your
device.
Working
with
the
wrong
voltage
will
cause
the
device
to
malfunction
or
may
permanently
damage
the
device.
Not
explosion-proof
Electrical
components
are
not
explosion-proof.
Do
not
use
in
an
area
where
flammable
gases
are
present.
Risk
of
electrical
shock
To
reduce
the
risk
of
electrical
shock,
do
not
remove
cover
(or
back).
Refer
servicing
to
qualified
service
per¬
sonnel.
Replacing
fuse
For
continued
protection
against
fire
hazards,
replace
the
fuse
only
with
a
fuse
of
the
same
type
and
ratings.
Internal
standard
settings
Check
all
settings
that
are
standard
to
your
work
place.
Such
interna!
standard
settings
are
not
necessarily
pre¬
scribed
for
the
doctor.
The
doctor
is
responsible
for
all
settings
that
pertain
to
his/her
operation.
Cleaning
the
device
Do
not
sterilize
the
device.
1-1
Warnings
Reading
the
manual
This
manual
describes
the
operation
and
the
intended
use
of
the
device
and
the
accessories.
It
is
essential
to
use
this
manual
to
familiarize
yourself
with
the
functions
and
the
operation
of
the
device
be¬
fore
using
it
in
the
operating
room.
E-4
1
SAFETY
INSTRUCTIONS
2
PURPOSE
OF
THE
DEVICE
Failure
to
follow
these
manual
instructions
can
result
in
serious
injury
to
the
patient
or
the
operating
team
and
can
lead
to
damage
or
destruction
of
the
device
and
ac-
cessories.
Professional
qualification
This
manual
does
not
provide
a
detailed
description
of
operation
techniques,
nor
is
it
suitable
for
introducing
a
beginner
to
this
operating
technique.
Medical
accesso¬
ries
and
devices
may
be
used
only
by
physicians
and
medical
assistants
under
the
direction
of
a
physician
with
the
appropriate
technical
qualification.
Sterile
substances
and
accessories
Always
work
exclusively
with
sterile
substances
sterile
fluids
and
sterile
accessories.
Replacement
device
and
accessories
In
case
the
pump
fails
during
an
operation,
a
replace¬
ment
device
and
replacement
accessories
should
be
kept
within
reach
so
that
the
operation
may
be
com¬
pleted.
Specific
device
warnings
Read
the
warnings
specific
to
this
device
under
chapter:
Purpose
of
the
Device.
Function
test
You
must
perform
the
function
test
(see
Function
Test
chapter)
before
you
begin
each
operation.
Device
deficiency
If
you
suspect
or
have
confirmed
that
the
device
is
de¬
fective,
stop
using
the
device
until
it
has
been
checked
by
authorized
service
personnel.
Endoscope
The
device
may
only
be
connected
to
endoscopes
which,
in
their
intended
use
and
technical
specifications,
are
appropriate
for
use
with
the
device
for
the
intended
medical
procedure.
The
endoscopes
must
comply
with
the
most
recent
version
of
DIN
EN
60601-2-18
and
ISO
8600.
Intended
Use
This
device
provides
fluid
distention
of
articular
cavities
for
diagnostic
and
/or
operative
arthroscopic
proce¬
dures.
Such
procedures
may
include:
•
Ligament
injuries
•
Meniscus
injuries
•
Cartilage
injuries
•
Operation
planning
and
re-examination
Refer
»°
your
arthroscope's
operator's
manual
for
spe-
cific
indications
for
use.
The
intraarticular
pressure
and
flow
can
be
preselected.
Once
the
preselected
pressure
level
has
been
reached,
the
device
automatically
interrupts
the
flow
of
fluid.
If
the
intraarticular
pressure
falls
below
the
preselected
level,
the
fluid
flow
will
automatically
be
re-initiated.
Recommended
pressure
The
device
is
indicated
for
use
in
the
following
joints.
The
listed
pressure
levels
are
generally
considered
ap¬
propriate.
although
circumstances
may
vary
from
pa¬
tient
to
patient
and
procedure
to
procedure.
These
val¬
ues
are
recommendations
and
are
not
intended
to
substitute
or
replace
the
expertise
of
the
surgeon.
90
mm
Hg
60
mm
Hg
50
mm
Hg
70
mm
Hg
60
mm
Hg
Contraindications
for
Use
Use
of
this
device
for
fluid
distention
is
contraindicated
whenever
arthroscopy
is
contraindicated.
Refer
to
your
arthroscope
s
operator's
manual
for
absolute
and
rela-
tive
contraindications.
The
device
is
contraindicated
for:
•
Ankylosis
Inflammation
or
bacterial
contamination
of
an
open
wound
The
device
is
not
intended
for
the
injection
of
medication.
Clinical
Use
When
performing
arthroscopic
electrosurgery,
the
dis¬
tention
medium
must
be
electrically
non-conductive.
Ex¬
amples
include
glycine,
sorbitol,
mannitol,
sorbitol
plus
mannitol,
and
dextran.
2-1
Cautions
Open
the
stopcocks
Failure
to
open
the
stopcocks
(inflow
and
outflow)
of
the
instrument
completely
during
the
recognition
phase
may
result
in
inaccurate
measurement
of
intraarticular
pressure.
Knee
Shoulder
Elbow
Ankle
Wrist
E-5
j
3
INITIAL
USE
OF
THE
DE¬
VICE
3
INITIAL
USE
OF
THE
DE¬
VICE
Initial
inspection
Check
the
device
and
all
accessories
immediately
upon
receipt
to
insure
that
the
contents
are
complete
and
that
nothing
is
damaged.
The
manufacturer
will
only
honor
claims
for
compensation
which
are
forwarded
immedi¬
ately
to
the
sales
representative
or
the
authorized
serv-
ice
company.
Returning
the
device
If
it
becomes
necessary
to
return
the
device,
use
of
the
original
packaging
is
required.
The
manufacturer
does
not
take
responsibility
for
damage
that
has
occurred
during
transportation
if
the
damage
was
caused
by
in-
adequate
transport
packaging.
Please
enclose
the
fol¬
lowing
information
with
the
device:
•
owner's
name
•
owner's
address
•
device
type
serial
number
of
the
equipment
(see
identification
plate)
•
description
of
the
damage.
Setting
up
the
device
Place
the
pump
on
a
level
surface
in
a
dry
place.
The
am¬
bient
temperature
should
be
between
10-40
“C
(50-104
F),
and
the
relative
air
humidity
should
be
between
30-
75
%.
CAUTION
!
The
electrical
components
are
not
explo¬
sion-proof.
Do
not
use
in
an
area
where
flammable
gases
are
present.
Potential
equalization
Integrate
the
device
into
the
potential
equalization
that
corresponds
to
your
local
electrical
system.
ii
I
Power
supply
connection
The
specifications
of
the
mains
power
supply
must
com¬
ply
with
I
EC,
CEC,
and
NEC
requirements.
Please
refer
to
the
back
of
the
device
(fuse
holder
or
de¬
vice
label)
to
determine
the
device's
operating
voltage.
CAUTION
!
~
Determine
if
the
available
voltage
corre¬
sponds
to
your
device.
Working
with
the
wrong
voltage
will
cause
the
device
to
malfunction
or
may
permanently
damage
it.
Safety
plug
The
power
supply
cable
must
be
equipped
with
a
safety
plug.
Use
the
enclosed
power
cable
for
the
connection
between
the
power
plug
and
the
device
socket.
For
the
American
user
Use
only
a
listed
detachable
power
supply
cable,
type
SJT,
minimum
18
AWG,
3
conductors,
one
end
configured
for
NEMA
5-15,
other
end
for
IEC
320/CEE22
Grounding
will
only
be
reliable
if
the
equipment
is
con¬
nected
to
a
corresponding
Hospital
Grade
socket.
E-6
4
OPERATING
THE
DEVICE
4
OPERATING
THE
DEVICE
4-1
Front
of
the
Device
(1)
Desired
pressure
display
with
Pressure
kev
and
_
.
'
minus
/
Pressure
|us
k
e
y
(2)
Desired
flow
display
with
Flow^
key
and
Flow
key
mtn,JS
pU
(3)
Roller
wheel
(4)
Pumphead
with
pressure
sensor
I
(5)
Pressure
sensor
II
(6)
Switch
for
pressure
chamber
(7)
Warning
displays
and
display
'Wash*
(8)
Actual
pressure
display
(9)
Program
keys
(10)
Connection
for
cable
remote
control
(11)
Power
switch
(12)
Start/Stop
key
4-2
Rear
of
the
Device
(1)
Connection
for
footpedal
(2)
Identification
plate
(3)
RS232-$erial
port,
connection
for
HERMES
Ready
System
(4)
Connection
for
potential
equalization
(5)
Device
socket
(6)
Fuse
box
4-3
Inserting
the
Tubing
Set
lllustr.:
4-3/1
The
sterile
tubing
set
consists
of
three
tubing
parts
®,
one
pressure
chamber
©,
one
tubing
fixing
©
and
one
insert
pin.
The
parts
of
the
tubing
are
specified
as
irrigation
®,
roller
©
and
instrument
tubings
<D
.
Inserting
the
roller
tubing
lllustr.:
4-3/2
Make
sure
that
the
membranes
(D
of
the
pressure
cham¬
ber
are
not
damaged
when
inserting
the
roller
tubing.
Ensure
that
there
is
no
liquid
in
the
tubing
prior
to
insert¬
ing
the
pressure
chamber.
1.
Remove
the
safeguard
for
transportation
from
the
pressure
chamber.
2.
Carefully
slide
the
pressure-free
pressure
chamber
©
(nose
©upwards)
into
the
cutout
of
the
pump
head.
The
pressure
chamber
has
to
snap
in
audibly
and
shut
flush
with
the
pump
head.
3.
Place
the
roller
tubing
©
around
the
roller
wheel.
4.
Stretch
the
tubing
and
insert
the
tubing
fixing
into
©
the
upper
part
of
the
pump
head.
Make
sure
that
the
tubing
fixing
snapped
in
tightly.
Connecting
the
instrument
tubing
Remove
the
protective
cover
from
the
instrument
tubing.
Connect
the
instrument
tubing
©
to
the
instrument
or
drainage
cannula.
Connecting
the
fluid
container
The
fluid
container
must
hang
0.7-1.0
m
above
the
de¬
vice.
Close
the
clamp
at
the
rinsing
tubing.
The
irrigation
tub¬
ing
©
has
been
prepared
to
take
in
irrigation
fluid
from
one
or
two
irrigation
container(s).
Whenever
a
tube
is
connected
to
or
disconnect
from
the
fluid
container,
be
sure
to
grasp
the
puncture
needle
at
the
appropriate
grip.
The
spike,
sterilized
by
the
manufacturer,
is
in¬
serted
into
the
container
in
accordance
with
prescribed
regulations
for
sterilization
in
operating
rooms.
Make
sure
to
use
only
fluid
containers
of
flexible
mate¬
rial
(plastic
sac).
CAUTION
!
"
There
is
a
danger
of
implosion
when
us¬
ing
glass
bottles
because
of
the
vacuum
which
build
s
up
in
the
bottle.
Provide
for
a
sterile
ventilation
of
inflexible
containers.
WARNING
I
The
choice
of
irrigation
fluid
is
deter¬
mined
by
the
physician
based
on
the
op-
eration
method
which
is
to
be
employed.
4-4
Turning
the
Device
on
Turn
the
device
on
using
the
power
switch
(position
l=on).
The
actual
pressure
display
briefly
indicates
\
The
power
switch,
and
the
digital
displays
will
light
up.
The
digital
displays
should
read:
Desired
pressure
0
[mm
Hg]
Desired
flow
0.10
[l/min]
Actual
pressure
0
[mm
Hg]
On
delivery
the
device
is
initially
programmed
with
the
following
settings:
Desired
pressure:
0
[mm
Hg]
Desired
flow:
0.10
[l/min]
Each
time
you
switch
the
device
on
and
off,
the
device
saves
the
last
entered
desired
pressure
and
flow
levels
and
shows
the
values
in
the
displays.
4-5
Start/Stop
Key
Insert
the
tubing
set
(see
chapter
4-3).
Press
the
Start/
Stop
key.
The
green
Start/Stop
LED
lights
up.
The
roller
wheel
starts
to
turn.
The
actual
pressure
display
indi¬
cates
the
actual
value.
If
the
tubing
set
is
not
inserted
and
you
press
on
the
start/stop
key
three
short
warning
beeps
will
be
heard
and
the
roller
wheel
will
not
start
moving.
Pressing
the
Start/Stop
button
a
second
time
stops
the
roller
wheel.
The
green
Start/Stop
LED
goes
out.
The
actual
pressure
display
shows
the
actual
value.
E-7
4
OPERATING
THE
DEVICE
4
OPERATING
THE
DEVICE
4-6
Automatic
Instrument
Recogni¬
tion
The
device
is
equipped
with
an
automatic
instrument
recognition
feature
which
enables
the
achievement
of
optimal
flow
rates
with
every
standard
instrument
on
the
market.
1
For
,he
ln,
b
a
l
i
za
t
i
o
n
of
the
automatic
instrument
recog-
1
n.tion,
a
minimum
desired
pressure
of
50
mm
Hg
and
a
|
minimum
desired
flow
of
0.80
l/min
must
be
preselected
I
when
starting
the
device.
After
initialization,
lower
j
pressure
and
flow
values
may
be
selected.
1.
Connect
the
fluid
container,
tube
and
instrument.
2.
Open
the
stopcocks
(inflow
and
outflow)
of
the
in¬
strument
completely.
WARNING
!
F<,
i
n
r
e
!°
?
P
.
0
"
,he
st
°
P
c
«
k
s
(inflow
and
outflow)
of
the
instrument
completely
during
the
recognition
phase
may
result
in
inaccurate
measurement
of
intraarticular
pressure.
3.
S
e
l
e
c
t
a
desired
pressure
of
50
mm
Hg
and
a
de¬
sired
flow
of
0.80
l/min.
Press
the
Start/Stop
key.
4
The
device
recognizes
the
connected
instrument
automatically.
The
roller
wheel
pump
may
briefly
run
at
various
speeds
and
stop
for
short
periods.
Intraoperative
instrument
change
An
intraoperative
instrument
change
may
only
be
per-
formed
after
pressing
the
Start/Stop
key.
Only
by
press¬
ing
the
Start/Stop
key
is
the
device
capable
of
perform-
ing
a
new
automatic
instrument
recognition.
1
In
order
to
change
instruments
during
the
operation,
press
the
Start/Stop
key
in
order
to
stop
the
pump.
2.
Connect
the
new
instrument.
3.
Open
the
stopcocks
(inflow
and
outflow)
of
the
in-
strument
completely.
4.
Press
the
Start/Stop
key
again.
Instrument
recogni¬
tion
is
initiated
automatically.
The
roller
wheel
pump
may
briefly
run
at
various
speeds
and
stop
tor
short
periods.
4-7
Preselecting
the
Desired
Pres¬
sure
You
can
preset
the
desired
pressure
between
0-150
mm
Hg.
The
desired
pressure
display
shows
the
preselected
value
in
mm
Hg.
You
can
control
the
various
functions
as
One
short
press
on
the
Pressure
key:
Reduction
of
the
desired
pressur'eby
1
mm
Hg
within
the
whole
selectable
range.
One
long
press
on
the
Pressure
key;
Continuous
reduction
of
the
desired
pressure
in
incre-
ments
of
10
mm
Hg
within
the
whole
selectable
range.
One
short
press
on
the
Pressure
plus
key:
Increase
of
the
desired
pressure
by
1
mm
Hg
within
the
whole
selectable
range.
One
long
press
on
the
Pressure
.
kev
on
inuousmcrease
of
the
desired
pressure
by
10
mm
Hg
within
the
whole
selectable
range.
4-8
Preselecting
the
Desired
Flow
You
can
preset
the
desired
flow
between
0.1-2.0
l/min
The
des.red
flow
display
shows
the
preselected
value
in
l/min.
You
can
control
the
various
functions
as
follows:
One
short
press
on
the
Flow
(
key;
Reduction
of
the
desired
flow
by
0.05
I/m
whole
selectable
range.
in
within
the
'w'HC
IU
"y
uri
rne
°
min
*ey
;
Continuous
reduction
of
the
desired
flow
in
increments
of
0.10
1/mm
within
the
whole
selectable
range.
One
short
press
on
the
Flow
p
l
us
key:
Increase
of
the
desired
flowby
0.05
l/min
within
the
whole
selectable
range.
One
long
press
on
the
Flow
p
(us
key:
Continuous
increase
of
the'desired
flow
by
0
10
l/min
within
the
whole
selectable
range.
The
height
of
the
fluid
bag
influences
the
flow
rate.
In
order
to
achieve
an
optimal
flow
rate,
hang
the
fluid
bag
exactly
1
meter
over
the
device.
4-9
Program
Keys
lllustr.:
4-9
With
the
three
program
keys
•
Knee
joint
CD
•
Shoulder
joint
©
•
Small
joints
(D
preselected
pressure
and
flow
values
may
be
saved
and
recalled
with
the
touch
of
a
key.
The
standard
on
deliv-
ery
values
are:
•
Knee
joint:
70
mm
Hg/1.0
l/min.
•
Shoulder
joint:
60
mm
Hg/2.0
l/min.
•
Small
joints:
50
mm
Hg/1.0
l/min.
You
may
save
your
own
values
as
follows:
1
Preselect
the
desired
pressure
and
flow
values
for
the
knee
joint.
2
,h
?
Knee
Joint
'
ke
Y
for
5
s
The
LED
on
the
key
blinks.
The
values
are
saved.
3.
For
the
shoulder
joint
and
small
joints,
proceed
as
described
in
steps
1
and
2.
above.
E-8
4
OPERATING
THE
DEVICE
5
SAFETY
FUNCTIONS
4.
Press
the
program
key
once.
The
saved
values
are
displayed
in
the
preselected
flow
and
preselected
pressure
display
windows.
4-10
Actual
Pressure
Display
The
pressure
is
measured
at
the
pressure
chamber.
The
pressure
display
is
calculated
by
means
of
the
measured
pressure
and
the
following
OP
parameters
•
hydrostatic
admission
pressure
•
flow
•
instrument
resistance
and
shown
in
the
actual
pressure
display
in
millimetres
mercury
column
[mm
Hg],
Follow
the
instructions
in
Chap¬
ter
4-6,
Automatic
instrument
detection,
exactly
for
the
best
possible
display
accuracy
of
the
intraarticular
pressure.
4-11
Warning
Displays
The
warning
displays
'Overpressure
1
and
'Service'
light
up
only
in
case
of
a
warning
or
malfunction
of
opera¬
tion.
Please
refer
to
chapter
Safety
Function.
4-12
RS232-Serial
Port
(Option)
The
pump
is
configured
to
be
attached
to
the
HERMES
Operating
Room
Control
Center
over
the
RS232-serial
port.
As
such,
the
pump
is
capable
of
direct
surgeon
con¬
trol
over
device
functions
and
adjustments
by
direct
voice
control
or
by
manual
use
of
a
hand
held
pendant
control.
It
is
recommended
that
the
physician
and
support
per¬
sonnel
be
thoroughly
familiar
with
the
setup
and
opera¬
tion
of
the
HERMES
Operating
Room
Control
Center.
Please
refer
to
the
HERMES
Operating
Room
Control
Center
for
the
proper
setup,
use
and
troubleshooting
of
the
Voice
Control
Interface
portion
of
that
device.
When
the
HERMES
Operating
Room
Control
Center
is
connected
and
active,
the
function
parameters
of
the
pump
may
simultaneously
be
adjusted
using
the
keys
on
the
front
panel
or
remote
control.
For
troubleshooting
or
further
information
please
refer
to
your
HERMES
Operating
Room
Control
Center
manual.
The
HERMES
Operating
Room
Control
Center
is
manu¬
factured
by
Computer
Motion
Inc.
The
proper
operation
of
the
pump
is
constantly
moni¬
tored
electronically.
Deficiencies
are
indicated
through
warning
signals,
warning
displays,
error
messages
and/
or
blocking
of
certain
functions.
Error
in
the
pressure
measurement
system
One
of
the
two
pressure
sensors
does
not
operate,
or
an
error
is
detected
in
the
pressure
measurement
system.
The
actual
pressure
display
indicates
'EOT,
the
warning
display
'Service'
lights
up,
a
warning
signal
is
heard,
and
the
pump
is
stopped.
Turn
the
device
off
and
on
again
after
10
s.
Should
the
er¬
ror
message
still
occur,
the
device
should
not
be
used
again.
Refer
to
qualified
service
personnel.
The
engine
control
mechanism
is
defective
If
the
actual
pressure
display
indicates
E02'
and
the
warning
display
'Service'
lights
up,
the
engine
control
mechanism
is
defective.
Check
if
the
pump
is
stuck.
Turn
the
device
off
and
on
again
after
10
s.
Should
the
er¬
ror
message
still
occur,
the
device
should
not
be
used
again.
Refer
to
qualified
service
personnel.
Incorrect
location
of
the
pressure
chamber
The
pressure
chamber
did
not
snap
into
the
pump
head.
When
pressing
the
Start/Stop
key,
three
warning
signals
are
heard
and
the
Start/Stop
LED
flashes.
The
pump
does
not
start.
Exceeding
the
desired
pressure
If
the
actual
pressure
exceeds
the
desired
pressure,
the
roller
wheel
turns
back
in
order
to
reduce
the
pressure.
An
audible
warning
signal
is
activated
should
the
roller
wheel
spin
backwards
for
an
extended
period
of
time.
Fluid
may
be
transported
from
the
joint
into
the
tubing
set.
Exceeding
the
desired
pressure
(30
mm
Hg)
If
the
actual
pressure
exceeds
the
desired
pressure
by
30
mm
Hg,
the
actual
pressure
display
flashes.
Exceeding
the
desired
pressure
(250
mm
Hg)
If
the
actual
pressure
has
reached
or
exceeded
250
mm
Hg
for
more
than
5
s,
the
actual
pressure
display
flashes,
the
warning
display
'overpressure'
lights
up,
and
a
warn-
ing
signal
is
heard.
The
roller
wheel
stops.
The
pump
starts
the
roller
wheel
automatically
when
the
pressure
has
fallen
below
2^
0
mm
Hg.
Internal
safety
system
If
the
actual
pressure
display
indicates
error
message
(e.g.
E02)
and
the
warning
signal
’Service'
lights
up,
this
means
the
pump
is
not
functioning.
The
irrigation
proc¬
ess
stops
or
cannot
be
activated.
I
E-9
5
SAFETY
FUNCTIONS
6
USER
MENU
Turn
the
pump
off
and
on
again
after
10
s.
Should
the
er¬
ror
message
still
occur,
the
device
should
not
be
used
again.
The
pump's
internal
safety
system
has
recognized
an
er-
ror.
Further
operation
is
not
possible.
Forbid
any
further
use
of
the
pump.
The
device
must
be
checked
by
a
qualified
service
technician.
With
the
user
menu
the
parameters
of
the
device
can
be
changed
and
displayed
before
the
operation.
There
are
three
different
menu
options:
P0:
shows
the
actual
software
version
PI:
selects
the
desired
pressure
which
should
automati¬
cally
be
activated
when
using
the
footpedal.
P2.
shows
the
actual
pressure
values
of
the
pressure
sensors
How
to
activate
the
user
menu
lllustr.:
6/1-6/3
1
Turn
the
device
on
using
the
power
switch.
2
While
—
flashes
in
the
actual
pressure
display
©
,
press
on
the
Pressure
.,
key
CD
.
The
desired
flow
display
will
show
PI.
The
’P*
flashes
®
.
3.
Press
the
Starf/Stop
key
®
'P'
stops
flashing
The
desired
pressure
display
®
(and
possibly
the
ac¬
tual
pressure
display)
shows
the
actual
parameters
of
the
activated
menu
option.
4.
The
Pressure
or
Pressure^,
key
®
changes
the
parameters
of
the
menu
options.
5.
Press
the
Start/Stop
key.
The
?'
flashes
again.
The
preselected
parameter
is
stored.
Another
menu
option
can
be
selected
using
the
Flov
V.
or
Flow
m
.
nu<
©
key.
6.
Turn
the
device
off.
After
it
has
been
turned
on
again,
it
is
ready
for
use.
Menu
option
P0
In
PO
the
actual
software
version
is
showed
Menu
option
PI
In
PI
select
the
desired
pressure
which
should
automati-
cally
be
activated
when
you
use
the
footpedal.
On
delivery
this
value
will
reflect
150
mm
Hg
Menu
option
P2
In
P2
the
actual
pressure
values
of
the
pressure
sensors
are
shown
in
the
desired
and
actual
pressure
display.
These
values
must
correspond
as
much
as
possible
(±4
mm
Hg).
7
OPTIONS
8
FUNCTION
TEST
7-1
Cable
Remote
Control
Using
the
cable
remote
control
option,
the
physician
can
operate
the
device
from
the
sterile
field.
CAUTION
!
It
is
only
allowed
to
use
the
remote
con¬
trol
dry
and
closed.
1.
Activate
the
device
with
the
power
switch.
2.
Connect
the
cable
remote
control
to
the
socket
on
the
front
of
the
device.
In
this
case
plug
first
the
adapter,
offered
by
the
dis¬
tributor,
to
the
socket
on
the
front
of
the
device
and
then
connect
the
cable
remote
control
to
the
adapter.
3.
You
can
activate
all
functions
of
the
device
with
the
remote
control:
•
Flow
•
Pressure
•
Wash
•
Start/Stop
Function
'Wash'
During
operation
the
desired
flow
and
desired
pressure
can
be
increased
quickly
using
the
Wash-Key.
The
de¬
sired
flow
will
change
automatically
from
the
prese¬
lected
(i.
e.
0,75
l/min)
value
to
the
max.
value
of
2.0
1/
min.
The
desired
pressure
value
can
be
selected
through
the
user
menu.
1.
Press
the
Wash-Key.
The
desired
flow
display
will
show
'2.00'
l/min
and
the
desired
pressure
display
will
show
the
value
selected
through
the
user
menu.
The
display
'Wash'
will
light
up.
2.
Press
the
Wash-Key
again.
The
desired
flow
and
de¬
sired
pressure
display
will
return
to
the
previously
selected
values.
7-2
Footpedal
During
operation
the
desired
flow
and
desired
pressure
can
be
increased
quickly
using
the
footpedal.
The
de¬
sired
flow
will
change
automatically
from
the
prese¬
lected
(0.75
l/min)
value
to
the
max.
value
of
2.0
l/min.
The
desired
pressure
value
can
be
selected
through
the
user
menu
(PI).
I
Connect
the
footpedal
to
the
connection
for
foot¬
pedal
on
the
rear
of
the
device.
2.
Step
on
the
footpedal.
The
desired
flow
display
will
show
’2.00’
l/min
and
the
display
'Wash'
will
light
up.
The
desired
pressure
display
will
show
the
value
selected
through
the
user
menu.
3.
With
another
step
on
the
footpedal
the
desired
flow
and
desired
pressure
display
will
return
to
the
previously
selected
values.
Increase
and
decrease
the
desired
flow
0
Increase
and
decrease
the
desired
pressure®
Quick
change
flow
and
pressure
(function
'wash')
®
Start/Stop
the
pump
©
The
function
test
is
for
checking
the
device,
the
tubing
set
and
the
instruments.
To
guarantee
safety
during
the
operation,
this
test
should
be
performed
prior
to
each
operation.
Sterilize
the
reusable
instruments
and
tubing
before
the
operation
to
prevent
infections.
Check
all
the
single-use
items
before
removing
them
from
the
package
to
ensure
that
the
packaging
is
intact
and
that
the
expiration
date
has
not
been
passed.
Use
only
an
original
tube
set
and
the
original
accesso¬
ries.
Control
of
the
device
1.
The
device
is
turned
off.
2.
Insert
the
tubing
set
(see
chapter
4-3).
Connect
an
instrument.
3.
Turn
the
device
on
using
the
power
switch.
The
ac¬
tual
pressure
display
shortly
shows
The
power
switch
and
the
digital
displays
light
up.
4.
Select
the
following
values:
Desired
pressure:
100
mm
Hg
Desired
flow:
0.80
!/min
5.
Press
the
Start/Stop
button.
The
green
Start/Stop
LED
lights
up.
6.
Fill
the
tubing
set
and
the
instrument
or
drainage
cannula
completely
with
fluid.
7.
Close
the
instrument
valve
or
the
stopcock
at
the
drainage
cannula.
The
actual
pressure
display
must
indicate
100
mm
Hg
(±5
mm
Hg)
when
the
roller
wheel
comes
to
a
standstill.
Control
of
the
function
'wash'
1.
Connect
the
cable
remote
control
or
footpedal
(chapter
7
Options).
2.
Press
the
Wash-Key
or
depress
the
footpedal.
The
desired
flow
display
will
show
'2.00'
l/min
and
the
desired
pressure
display
will
show
the
value
which
was
selected
through
the
user
menu
(at
delivery
150
mm
Hg).
The
display
'Wash'
will
be
illuminated.
3.
Press
the
Wash-Key
or
depress
the
foot
pedal
again
and
the
desired
flow
and
desired
pressure
displays
will
return
to
the
previously
selected
val¬
ues.
4.
When
this
value
has
been
reached,
the
function
control
is
successfully
completed.
The
device
is
tested
and
ready
to
be
used
in
the
operating
room.
E-ll
8
FUNCTION
TEST
9
USE
OF
THE
DEVICE
DURING
OPERATION
CAUTION!
If
a
device
defect
is
determined
or
sus¬
pected
during
the
function
test,
discon¬
tinue
use
of
the
device
until
it
has
been
repaired
by
an
authorized
service
techni¬
cian.
This
is
also
true
if
the
device
fails
to
maintain
the
indicated
tolerance
levels.
CAUTION
!
Never
use
the
device
if
it
has
obvious
de¬
fects,
especially
if
these
involve
the
power
plugs
or
the
power
supply
connec¬
tion
cables.
Have
the
device
repaired
by
an
authorized
service
technician.
This
chapter
provides
general
information
about
the
use
of
the
device.
Only
the
physician
can
evaluate
the
clini¬
cal
factors
involved
with
each
patient
and
determine
if
the
use
of
this
device
is
indicated.
The
physician
must
determine
the
specific
technique
and
procedure
that
will
accomplish
the
desired
clinical
effect.
To
guarantee
the
patient's
safety
the
device
function
test
must
be
performed
prior
to
each
use.
Please
read
chapter
5
on
safety
functions
carefully
be¬
fore
using
the
pump.
Chapter
5
explains
all
the
safety
features,
visual
and
acoustic
warnings,
and
the
error
messages
in
detail.
Make
sure
that
the
pump
is
level
with
the
instrument.
Due
to
hydrostatic
pressure,
a
difference
in
height
influences
the
pressure
measurement
(lllustr.:
9).
WARNING
!
The
type
of
irrigation
fluid
to
be
used
must
be
decided
by
the
physician
based
on
the
operation
method
to
be
employed!
Before
the
Operation
1
Select
the
desired
pressure
and
flowrate.
2.
Press
the
Start/Stop
button.
The
roller
wheel
starts
turning.
3.
Insert
the
instrument
or
drainage
cannula
into
the
joint.
The
device
will
adjust
the
process
of
joint
distension
in
accordance
with
the
preselected
pressure
and
flow
val¬
ues.
Once
the
desired
pressure
has
been
reached
the
ac¬
tual
flow
will
be
automatically
reduced.
After
the
Operation
1.
Press
the
Start/Stop
button.
The
Start/Stop
LED
will
extinguish.
2.
Turn
the
pump
off
using
the
power
switch.
3.
Remove
the
tubing
set.
Pay
attention
to
local
hy¬
giene
regulations
when
disposing
of
the
tubing
set.
NOTE
!
“
When
you
use
pumping
solutions
that
contain
sugar
(high
frequency
use),
we
recommend
that
you
use
the
pump
to
flush
out
the
tubing
set
after
you
have
re¬
moved
the
fluid
receptacle
and
discon¬
nected
the
instrument.
10
SERVICE
AND
MAINTENANCE
To
preserve
the
pump
and
ensure
its
proper
functioning,
proper
service,
maintenance
and
storage
must
be
pro¬
vided
for.
To
protect
the
patient
from
infections,
all
ac¬
cessory
items
that
come
into
contact
with
human
tissue
(e
g.,
tubing
and
instruments)
must
be
sterilized.
Cleaning
the
Device
After
each
use,
turn
off
the
power
switch
and
remove
the
power
cable
from
the
connection
at
the
rear
of
the
de¬
vice.
Use
a
hydrous
disinfecting
solution
to
clean
the
exterior
of
the
device.
Follow
instructions
provided
by
the
disin¬
fectant
manufacturer
to
determine
the
correct
fluid
con¬
centration.
Moisten
a
cloth
with
the
disinfectant
solution
and
wipe
the
surface
of
the
device.
Strictly
avoid
entry
of
fluid
into
the
device.
CAUTION
!
~
~
Do
not
sterilize
the
device
J
10-2
Cleaning
of
the
Reusable
Sili¬
cone
Tubing
Set
(not
for
USA)
Dismantle
the
tubing
set.
Wash
the
parts
carefully
with
cold
and
warm
water.
After
a
thorough
cleaning
and
rinsing
with
demineralized
water,
let
all
parts
drip,
and
afterwards
dry
them
with
a
sterilized
soft
cloth
and
swabs.
Note
about
the
membranes
lllustr.:
10-2
Of
particular
importance,
the
membranes
©
must
be
re¬
moved
from
the
pressure
chamber
®
for
cleaning.
For
re¬
moval
of
the
membrane,
grip
the
tab
®
and
pull
the
membrane
upwards.
CAUTION
!
--
Remove
the
membranes
prior
to
pressu¬
rized
air
cleaning!
Please
ensure
that
the
membrane
is
placed
properly
back
into
the
pressure
chamber
(prior
to
sterilization).
Place
the
lip
<3>
of
the
membrane
in
the
ring
nut
©
of
the
pressure
chamber.
The
tab
©
should
be
directly
above
the
gap
©
.
Press
the
lip
of
the
membrane
into
the
ring
nut
©
.
The
membrane
must
be
level
with
the
edge
of
the
pressure
chamber.
Ensure
that
there
are
exist
no
crimps
or
folds
in
the
membrane.
10
SERVICE
AND
MAINTENANCE
10-3
Disinfection
of
the
Reusable
Silicone
Tubing
Set
(not
for
USA)
WARNING
I
Disinfection
of
the
tubing
and
instruments
is
insufficient
to
achieve
sterility
at
SAL
10-
6
.
Further
sterilizotion
is
required.
Only
thoroughly
cleaned
tubing
is
to
be
disinfected.
The
tubing
should
be
put
into
the
solution
(i.
e„
Cidex,
John¬
son
&
Johnson
Medical)
separately,
with
all
endings
open.
The
manufacturer
of
the
disinfectant
specifies
the
soaking
time
and
the
appropriate
solution
concentra-
Hon.
CAUTION
!
'
Do
not
leave
silicone
tubing
or
other
sili¬
cone
parts
in
the
solution
for
more
than
30
minutes.
Silicone
absorbs
different
disinfection
solutions
and
is
damaged
when
subsequently
sterilized
in
a
steam
autoclave.
Take
the
tubing
set
out
of
the
solution
using
forceps
with
a
soft
edge
Remaining
disinfection
solution
on
the
tub¬
ing
should
be
rinsed
with
sterile
water
under
sterile
con¬
ditions.
Dry
all
parts
with
a
sterile
cloth
and
wrap
them
in
a
separate
sterile
cloth.
Prior
to
sterilization,
assemble
all
components
of
the
tubing
set.
For
temporary
storage,
keep
the
tubing
in
a
closed,
sterile
container.
10-4
Sterilization
of
Reusable
Sili¬
cone
Tubing
Set
(not
for
USA)
The
maximum
number
of
sterilization
cycles
for
the
tub¬
ing
set
is
determined
by
the
manufacturer
(see
tubing
packaging).
Never
exceed
the
number
of
uses
recom¬
mended
by
the
manufacturer.
CAUTION
!
"
"
Using
the
silicone
tabs
attached
to
the
tube
set
record
the
number
of
steriliza¬
tion
cycles
completed.
The
tube
set
may
not
be
sterilized
after
the
last
silicone
tab
has
been
removed.
Sterilization
in
a
Steam
Autoclave
Only
cleaned,
disinfected,
dried
and
assembled
tubing
should
be
sterilized
in
steam.
Please
follow
the
operat-
ion
manual
of
the
autoclav©
you
us©.
E-13
10
SERVICE
AND
MAINTENANCE
SERVICE
AND
MAINTENANCE
10-5
Sterilization
Conditions
(not
for
USA)
Autoclaving
Sterilization
with
steam
must
be
completed
under
the
following
conditions:
Fractional
vacuum
procedure
134
°C
/
3
bar
/
5
min
272
°F
/
43.5
PSI
/
5
min
CAUTION
!
It
is
the
responsibility
of
the
user
to
qualify
any
deviation
from
the
recom¬
mended
processing
method.
The
manufac¬
turer
is
not
responsible
for
damage
or
in-
|ury
resulting
from
non-adherence
to
the
recommended
processing
method.
10-6
Cleaning
the
Autoclavable
Remote
Control
CAUTION
!
"
The
remote
control
must
be
opened
before
cleaning
and
sterilisation
(lll
u
s
t
r
.:
10-6).
Use
a
brush
and
only
a
mild,
pH-neutral
detergent
to
clean
the
remote
control.
10-8
Sterilisation
conditions
for
the
autoclavable
remote
control
NOTE!
"
"
sterility
of
the
product.
Your
own
hygiene
institute
remains
responsible
for
the
vali¬
dation
of
the
sterilisation
and
sterility.
Temperature
Time
Sat.
steam
sterilisation
273
(134
°C)
5
min.
Sat,
steam
sterilisation
248
°F
(120
°C)
20
min.
Gamma
Ray
and
Beta-Ray
sterilisation
Gamma
Ray
and
Beta-Ray
sterilisations
may
not
be
car-
ried
out.
10-9
Annual
Inspection
Manufacturer's
Requirement
The
manufacturer
stipulates
that
the
user
or
a
hospital
technician
must
regularly
test-the
device
to
assess
its
functionality
and
technical
safety.
These
tests
must
be
performed
on
an
annual
basis.
The
tests
are
described
in
the
Annual
Inspection
chapter.
Regular
inspections
will
assist
in
early
detection
of
pos¬
sible
malfunctions,
helping
to
preserve
the
device
and
increases
its
safety.
DANGER
!
~
~
Make
sure
that
there
are
no
secretion
residues,
tissue
residues
or
other
foreign
bodies
on
the
remote
control
before
sterilisation.
NOTE
!
“-—
Make
sure
that
the
remote
control
is
open
during
disinfecting
and
is
fully
rinsed
bv
the
fluid.
10-7
Sterilising
the
Autoclavable
Remote
Control
The
remote
control
has
been
tested
by
the
manufacturer
for
a
certain
number
of
sterilisations
(exact
number
see
label).
Never
exceed
the
number
of
sterilisations
speci¬
fied
by
the
manufacturer.
Saturated
steam
sterilisation,
autoclaving
Only
a
cleaned,
disinfected,
dry
and
open
remote
con¬
trol
can
be
sterilised
by
saturated
steam.
Please
follow
the
instructions
in
the
operating
manual
for
your
auto¬
clave.
10-10
Maintenance
by
the
Authorized
Service
Technician
Maintenance
every
two
years
To
guarantee
the
operational
safety
of
the
pump,
the
de¬
vice
must
be
maintenanced
at
regular
intervals
by
an
au¬
thorized
service
technician.
Depending
on
the
duration
and
frequency
of
use,
the
device
should
be
mainte¬
nanced
every
two
years.
Failure
to
adhere
to
this
mainte¬
nance
schedule
will
result
in
the
manufacturer
refusing
li¬
ability
for
the
operational
safety
of
the
pump.
A
sticker
on
the
rear
wall
of
the
casing
displays
the
lat¬
est
possible
date
for
the
next
maintenance
check.
Authorized
service
technicians
All
services
such
as
alterations,
repairs,
calibrations,
etc
may
only
be
performed
by
the
manufacturer
or
by
service
technicians
who
are
authorized
by
the
manufac-
turer.
Unauthorized
service
technicians
If
an
unauthorized
service
technician
performs
mainte¬
nance
or
any
other
service,
the
manufacturer
will
not
ac¬
cept
liability
for
the
operational
safety
of
the
device.
Liability
The
manufacturer
is
freed
from
all
liability
for
the
opera¬
tional
safety
of
the
device
if
it
has
been
wilfully
opened
and
unauthorized
persons
have
performed
repairs
or
al¬
terations
on
it.
E-14
11
ANNUAL
INSPECTION
11
ANNUAL
INSPECTION
Certification
The
pump
owner
should
receive
a
certificate
from
the
au¬
thorized
service
technician
for
all
maintenance
checks
or
repairs.
This
certificate
states
the
type
and
scope
of
the
services
rendered,
the
service
date
and
the
name
of
the
service
company.
The
certificate
should
be
signed.
Technical
documentation
Receipt
of
technical
documentation
from
the
manufac¬
turer
does
not
authorize
individuals
to
perform
repairs,
adjustments
or
alterations
on
the
device
or
accessories.
Only
an
authorized
service
technician
may
perform
re¬
pairs,
adjustments
or
alterations
on
the
device
or
acces¬
sories.
10-11
Replacing
the
Fuse
Defective
fuse
If
the
power
switch
is
on
T,
yet
the
displays
and
LEDs
do
not
light
up
and
the
device
does
not
function,
then
the
fuse
may
be
defective
and
is
need
of
replacement.
Ensure
that
the
mains
power
supply
cable
is
properly
connected
to
the
power
supply
input
and
to
a
safety
socket.
Check
if
the
house
power
supply
fuse
is
function¬
ing
and
if
the
voltage
supply
matches
the
specification
on
the
fuse
holder.
CAUTION
!
Unplug
the
power
supply
cable
from
the
device
before
checking
the
fuse.
1.
Unfasten
the
snap
grip
of
the
fuse
holder
with
a
small
screwdriver.
2.
Pull
out
the
fuse
holder
and
check
the
fuses.
3.
Insert
a
new
fuse.
Use
only
the
prescribed
fuses
(see
Technical
Data
chapter).
4.
Press
the
fuse
holder
until
it
snaps
into
place.
5.
Use
the
mains
power
supply
cable
to
connect
the
plug
at
the
rear
of
the
device
to
the
mains
power
socket.
Simple
tests
The
tests
described
here
are
designed
for
users
or
hos¬
pital
technicians.
The
operation,
function
and
perform¬
ance
of
the
device
may
be
tested
in
a
simple
manner.
Please
document
each
test
in
the
test
record.
Remember
to
sign
and
date
the
protocol
(see
chapter
Test
Record).
Values
and
tolerance
levels
The
following
measuring
tools
and
aids
were
used
to
de¬
termine
the
measurements
and
tolerance
levels
indi¬
cated
in
the
chapter
Technical
Data:
•
Tubing
set
•
1
beaker
tared
(1.0
I)
•
1
fluid
container
•
Ruler
50
cm
If
those
values
and
tolerance
levels
are
not
maintained,
have
the
device
checked
by
authorized
service
person¬
nel.
Data
sheet
The
manufacturer
conducts
a
complex
functions
and
safety
test
on
each
device
prior
to
deliver.
The
results
of
our
quality
control
testing
are
documented
on
the
data
sheet.
11-1
Safety
Test
A
safety
test
is
to
be
completed
within
the
framework
of
the
annual
inspection
by
qualified
personnel.
1.
Perform
a
visual
inspection
of
the
device.
Of
par¬
ticular
importance
is:
•
The
fuses
are
in
accordance
with
the
specifications
of
the
manufacturer.
•
The
text
and
labels
on
the
device
are
legible.
•
The
mechanical
condition
of
the
device
allows
for
safe
use.
•
No
safety
relevant
contamination
of
the
device
ex¬
ists.
2.
Perform
the
measurement
of
the
leakage
current
in
accordance
with
DIN
EN
60601-1
/
IEC
601-1.
3.
Perform
the
measurement
of
the
protective
conduc¬
tor
resistance
in
accordance
with
DIN
EN
60601-1
/
IEC
601-1.
The
protective
conductor
resistance
should
be
measured
with
the
power
cord
con¬
nected.
The
maximum
value
should
reflect
0.2
12.
4.
Perform
the
measurement
of
the
insulation
(resist¬
ance)
with
500-700
V
DC.
The
minimum
value
should
reflect
50
M£2.
The
measurement
of
rigging
strength
should
not
be
performed
using
high
voltage.
11-2
Basic
Function
Test
The
basic
function
test
checks
the
displays,
keys
and
the
performance
of
the
device.
In
order
to
perform
this
test,
the
tubing
set,
a
fluid
container
and
a
scaled
beaker
(1.0
I)
are
required.
E-15
mm
11
ANNUAL
INSPECTION
11
ANNUAL
INSPECTION
Preparing
the
Test
1.
Insert
the
tubing
set
(lllustr.:
11-2).
2.
The
pressure
chamber
must
snap
in
audibly.
3.
Connect
the
irrigation
tubing
to
a
fluid
container.
The
fluid
container
must
hang
1.0
m
above
the
de¬
vice.
4.
Place
the
instrument
tubing
in
a
beaker.
5.
Turn
the
device
on
using
the
power
switch.
Select
the
following
values:
desired
pressure:
150
mm
Hg
desired
flow:
1.00
l/min
6.
Press
the
Start/Stop
button.
The
green
Start/Stop
LED
lights
up.
The
roller
wheel
starts
turning.
7.
Fill
the
tubing
set
completely
with
fluid
and
let
the
pump
run
for
1
min
to
finish
the
automatic
instrument
recognition.
8.
T
h
e
n
clamp
the
instrument
tubing
closed.
Do
not
press
the
Start/Stop
button.
Performing
the
Test
1.
Empty
the
beaker.
2.
Release
the
clamp
on
the
instrument
tubing
and
time
one
minute.
3.
At
the
end
of
this
time
press
the
Start/Stop
button.
The
beaker
must
contain
1.0
I
(±10%)
water.
When
this
value
has
been
reached,
the
function
control
is
successfully
completed.
11-3
Testing
the
Measurement
of
Pressure
The
pressure
measurement
test
checks
the
proper
opera¬
tion
of
the
pressure
chamber,
the
pressure
sensors
and
the
applied
pressure.
In
order
to
perform
this
test,
a
com¬
plete
tubing
set
and
a
beaker
filled
with
water
are
re¬
quired.
Here
the
height
of
the
water
column
(hydrostatic
pres¬
sure)
is
measured
and
the
result
then
converted
into
milli¬
metre
mercury
column.
After
the
conversion,
the
height
of
the
water
column
above
the
pressure
chamber
must
correspond
to
the
value
of
the
actual
pressure
display.
Conversion
formula:
p
(cm
H
2
0
)
x
0.74
=
p
(mm
Hg)
Place
the
irrigation
tubing
into
a
container
filled
with
water
(lllustr.:
11-3).
Fill
the
tubing
set
with
water
up
to
the
patient
con¬
nection.
Press
the
Stop/Start
key
to
stop
the
pump.
Close
the
end
of
the
patient
tubing
(close
the
tub¬
ing
with
your
finger).
Hold
the
water
gauge
of
the
patient
tubing's
end
(h)
44
cm
above
the
pressure
chamber.
The
width
of
the
device
(36
cm)
can
serve
as
a
measuring
aid.
Add
the
height
between
pressure
chamber
and
the
case
upper
half
(8
cm)
to
the
36
cm.
The
water
column
reaches
a
total
of
44
cm
above
the
pressure
chamber
(44
cm
H
2
0
x
0.74
=
approx.
33
mm
Hg).
5.
Release
the
patient
tubing.
6.
The
actual
pressure
display
must
indicate
33
mm
Hg
(±5
mm
Hg).
7.
Change
the
height
of
the
water
column.
The
indi¬
cated
value
of
the
actual
pressure
display
must
fol¬
low
the
change.
The
test
of
the
measurement
of
pressure
is
successfully
completed
when
the
values
of
the
actual
pressure
dis¬
play
correspond
to
those
of
the
water
column.
11-4
Test
of
the
Pressure
Sensors
This
test
checks
the
correct
function
of
the
pressure
sen¬
sors.
1.
Remove
the
pressure
chamber
from
the
pump
head
(lllustr.:
11-4).
2.
Gently
touch
the
upper
pressure
sensor
©
with
your
finger.
3.
The
actual
pressure
display
indicates
’EOT,
the
warning
display
'Service'
lights
up,
and
a
warning
signal
is
heard.
4.
Repeat
the
test
with
the
lower
sensor
(D
.
5.
Select
item
P2
of
the
user
menu.
The
desired
pres¬
sure
and
actual
pressure
display
indicate
a
value.
These
values
must
be
the
same
(±4
mm
Hg).
If
the
discrepancy
is
larger,
the
device
must
be
reset
by
a
certified
technician.
The
test
of
the
pressure
sensors
is
completed.
Please
record
the
successful
performance
of
the
test
in
the
following
test
protocol.
E-16
12
TEST
RECORD
Date
Result
Remarks
Sign
13
TECHNICAL
DATA
Power
Supply
Frequency
Power
Consumption
Max.
Current
Protection
Class
Dimensions
Weight
Operation
Directions
Storage
and
Transportation
Directions
Manufactured
and
Tested
acc.
to
EMC
Pump
Capacity
Pressure
Area
Max.
Suction
Pressure
Displays
Accuracy
of
Measurement
High
Pressure
Safety
Connections
100-240
V~
Mains
fuse
T
5
A
Connection
for
equipotentiality
50-60
Hz
75
W
100
V:
1.0
A
240
V:
0.2
A
Class
I,
Type
BF
Width
x
height
x
depth
360x145x300
[mm]
Approx.
7.5
kg
10-40
°C/
50-104
°F
30-75
%
rel.
air
humidity
-40
to
+70
X
/
-40
to
+159
°F
10-100
%
rel.
air
humidity
IEC
601-1
IEC
601-1-2
0.1-2.0
l/min
0-150
mm
Hg
During
Pressure
Release
500
mm
Hg
Desired
pressure
0-150
mm
Hg
Actual
pressure
0-350
mm
Hg
Desired
flow
0.1-2.0
l/min
Pressure
measurement
±6
%
Flow
measurement
±10
%
Engine
shutdown
above
250
mm
Hg
after
5
Foot
pedal,
pneumatic
Cable
remote
control
RS232-Serial
Port
E-18
14
INDEX
14
INDEX
A
Actual
Pressure
Display
9
American
user
6
Annual
Inspection
14
Autoclavation
14
Automatic
Instrument
Recognition
8
Available
voltage
4
B
Basic
Function
Test
15
c
Cable
Remote
Control
11
Care
and
maintenance
4
Cleaning
of
the
Reusable
Silicone
Tubing
Set
13
Cleaning
the
Device
13
Cleaning
the
device
4
Clinical
Use
5
Computer
Motion
9
Connection
for
footpedal
7
Connection
for
potential
equalization
7
Contamination
4
Contraindications
for
Use
5
Control
of
the
device
11
Control
of
the
footpedal
11
D
Desired
flow
display
7
Desired
pressure
display
7
Device
deficiency
5
Device
socket
7
Disinfection
of
the
Reusable
Silicone
Tubing
Set
13
Display
'Footpedal'
7
E
Endoscope
5
explosion-proof
4
F
Federal
law
4
Front
of
the
Device
7
Function
test
5
function
test
11
Fuse
15
Fuse
box
7
G
General
Information
2
H
HERMES
9
HERMES
Ready
System
7
I
Identification
plate
7
Initial
inspection
6
Inserting
the
Tubing
Set
7
Intended
Use
5
Internal
standard
settings
4
Intraoperative
instrument
change
8
M
Maintenance
by
the
Authorized
Service
Technician
14
o
Original
accessories
4
P
PI
10
P2
10
Potential
equalization
6
Power
supply
connection
6
Power
switch
7
Preselecting
the
Desired
Flow
8
Preselecting
the
Desired
Pressure
8
Pressure
sensor
7
Professional
qualification
5
Program
Keys
8
Pumphead
'
7
R
Reading
the
manual
4
Rear
of
the
Device
7
Recommended
pressure
5
Remote
control
11,
14
Replacement
device
and
accessories
5
Replacing
the
Fuse
4,
15
Returning
the
device
6
Risk
of
electrical
shock
4
Roller
wheel
7
R$232-Serial
Port
9,
18
s
Safety
plug
6
Safety
Test
15
Setting
up
the
device
6
Specific
device
warnings
5
Start/Stop
Key
7
Start/Stop
key
7
Sterile
substances
and
accessories
5
Sterilization
Conditions
14
Sterilization
of
Reusable
Silicone
Tubing
Set
13
Stopcocks
5
T
Technical
Data
18
Turning
the
Device
on
7
u
user
menu
10
w
Warning
Displays
9
Warning
displays
7
Warnings
4
Warranty
4
Waste
management
4
Water
hazard
4
E-19
15
TROUBLESHOOTING
INSTRUCTIONS
Error/Alarm
Indicator
Source
of
Error
Elimination
of
Errors
Start/Stop
LED
flashes,
three
short
warning
signal
are
heard.
The
pressure
chamber
did
not
snap
in
Remove
the
pressure
chamber
from
the
pump
head.
Press
the
pressure
chamber
into
the
pump
head.
The
pressure
chamber
must
snap
in
audibly.
Service
icon
is
lit,
actual
pressure
display
indicates
£01'
warning
signal
is
heard
The
difference
between
the
two
pressure
sensors
is
more
than
50
mm
Hg
Turn
the
device
off
at
the
main
switch
and
after
10
s
again
on.
Should
the
error
message
appear
again,
the
device
is
defective.
Prevent
all
unauthorized
persons
from
using
the
device,
inform
the
service
center
that
they
should
check
the
device.
Service
icon
is
lit,
actual
pressure
display
indicates
£0T,
warning
signal
is
heard
The
engine
control
mechanism
is
defective
Check
to
see
if
the
tube
is
caught
in
the
roller
wheel.
Turn
the
device
off
at
the
power
switch
and
after
10
s
again
on.
Should
the
error
message
appear
again,
the
device
is
defective.
Prevent
all
unauthorized
persons
from
using
the
device.
Inform
the
service
center
that
they
should
check
the
device.
Service
icon
is
lit,
it
is
possible
to
hear
a
warning
signal
The
device
is
defective.
Turn
the
device
off
at
the
power
switch
and
after
10
s
again
on.
Should
the
error
message
appear
again,
the
device
is
defective.
Prevent
all
unauthorized
persons
from
using
the
device.
Inform
the
service
center
that
they
should
check
the
device.
The
actual
pressure
display
flashes
The
intraarticular
pressure
exceeds
the
desired
pressure
by
30
mm
Hg.
Please
note
that
the
flashing
of
the
actual
pressure
display
is
an
information
for
you,
that
the
desired
pressure
has
been
exceeded.
Warning
display
'overpressure'
is
lit
the
actual
pressure
display
flashes,
a
warning
signal
is
heard,
the
roller
wheel
stops
The
intraarticular
pressure
exceeds
250
mm
Hg
Reduce
the
intraarticular
pressure.
Open
the
drainage
valve
on
the
instrument.
The
device
starts
automatically
after
reducing
the
pressure
below
250
mm
Hg.
The
roller
wheel
spins
backwards
The
intraarticular
pressure
exceeds
the
desired
value
Please
note
that
the
automatic
venting
system
is
working
to
reduce
intra¬
abdominal
pressure.
Warning
signal
is
heard
The
roller
wheel
spins
backwards
Fluid
is
transported
out
of
the
joints
into
the
tubing
system.
Please
observe
the
potential
of
contamination
of
the
tubing
set.
After
every
use,
the
entire
tubing
set
and
the
fluid
container
must
be
replaced
This manual suits for next models
1
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