Sutter CURIS flow User manual

INSTRUCTIONS FOR USE
CURIS®flow Irrigation pump
REF 350950

Read carefully before use
and retain for future reference!

CURIS®flow Instructions for Use
i
Table of contents
1EXPLANATION OF SYMBOLS AND ABBREVIATIONS ...................................................................... 1
2SYSTEM DESCRIPTION.................................................................................................................... 3
2.1 Function and meaning of the display and control elements................................................ 3
2.2 Intended use ........................................................................................................................... 5
2.2.1 Purpose ........................................................................................................................... 5
2.2.2 Contraindications ........................................................................................................... 5
2.2.3 Side effects ..................................................................................................................... 5
2.2.4 Essential performance characteristics ......................................................................... 5
3COMMISSIONING ............................................................................................................................ 5
3.1 Setup for use with the corresponding footswitch ................................................................. 5
3.2 Potential equalization connection ......................................................................................... 6
3.3 Mains connection.................................................................................................................... 6
3.4 System start and self-test....................................................................................................... 6
3.5 Inserting the bipolar cord and tubing set .............................................................................. 7
4OPERATION...................................................................................................................................... 8
4.1 Additional operating functions ............................................................................................... 9
4.2 Decommissioning..................................................................................................................10
5SAFETY MEASURES AND PRECAUTIONS .....................................................................................10
6CLEANING AND DISINFECTION.....................................................................................................11
7ERROR DISPLAY AND TROUBLESHOOTING .................................................................................11
7.1 Maintenance and repair .......................................................................................................14
8ACCESSORIES................................................................................................................................14
9TRANSPORTATION AND PACKAGING ...........................................................................................15
9.1 Incoming inspection and transport damage .......................................................................15
9.2 Claims for damages..............................................................................................................16
9.3 Returns ..................................................................................................................................16
9.4 Device disposal .....................................................................................................................16
10 TECHNICAL INFORMATION............................................................................................................17
10.1 Technical data, standards, certification ..............................................................................17
10.2 Guidelines and manufacturer declaration for electromagnetic compatibility ..................17
10.2.1 Electromagnetic emissions..........................................................................................18
10.2.2 Electromagnetic interference resistance....................................................................18

1
1Explanation of symbols and abbreviations
Warning, attention
Note
Temperature limit
Relative humidity limit
Air pressure limit
Medical device
Compliant with Regulation 2017/745/EU (MDR)
Sale restricted to attending physicians (USA)
Disposal notice (WEEE symbol)
Manufacturer
Manufacturing date
Catalog number
Serial number
Observe the instructions for use
/ PA
Potential equalization
/ CF
Type CF applied part (Cardiac Floating)
Error (fault indication or error message)
This side up
Protect against moisture
Caution, fragile
IP21
Protection class (IP class)
°C
Degrees Celsius
%
Percent
Ø
Diameter

2
AC
Alternating current
A/m
Ampere/meter
cm
Centimeter
dB(A)
Assessed sound pressure level
EMC
Electromagnetic compatibility
ESD
Electrostatic discharge
GHz
Gigahertz
hPa
Hectopascal
HF
High frequency
Hz
Hertz
kg
Kilogram
kHz
Kilohertz
kV
Kilovolt
m
Meter
mA
Milliampere
ml
Milliliter
max.
Maximum
MHz
Megahertz
min
Minute
mm
Millimeter
PE
Potential equalization
RF
Radio frequency
V
Volt
VA
Volt-ampere
Veff.
Effective value
V/m
Volt/meter
W
Watts

3
2System description
The CURIS®flow is an irrigation pump for the supply of isotonic saline solution to the surgical area
with the integrated peristaltic pump, an insertable irrigation tubing and a bipolar irrigation
instrument. The selected flow setting is displayed on the irrigation pump and can be changed using
a control element. It can be used with the corresponding one-pedal footswitch with push-button,
available as an option (see accessories in Chapter 8).
Scope of delivery:
1x CURIS®flow Irrigation pump (REF: 350950)
1x US mains cable (REF: 93001047)
1x CURIS®RF Generator interconnecting cable (REF: 93008120)
1x Instructions for use (REF: 899080-XX)
1x CURIS®flow IV pole mounting bracket (REF: 360901)
2.1 Function and meaning of the display and control elements
Front of the device:
1
Power switch
Turns the irrigation pump on and off
2
Display
Shows the selected flow setting
3
Flow setting control element
Turning clockwise increases, turning counterclockwise decreases the flow rate
4
Flush function button
Pressing the “Flush” button activates the irrigation pump with a predefined, fixed
flow setting
(max. flow rate)
5
LED status indicator
Lights up red and indicates a device defect
6
Pause function button
Pressing the “Pause” button activates pause mode
, supply of irrigation fluid is paused and the
flow setting on the display starts flashing
7
Rotary pump with flow direction indicator
Pumps the irrigation fluid in the specified
flow direction through the inserted bipolar cord /
tubing set or irrigation tubing to the surgical area
8
Rotary pump lock lever
1
3
4
6
5
2
8
7

4
Back of the device:
9
Connection socket
For the optional CURIS
®
flow one-pedal footswitch with push-button (REF: 360115)
10
Mains cable connection socket
11
PE connection for electric potential equalization
To establish a potential equalization connection in rooms where potential equalization is
required
12
Type plate
Bottom of the device:
13
IV pole mounting bracket connection socket
For connecting
the supplied CURIS®flow IV pole mounting bracket (REF: 360901)
NOTE
In the chapters that follow, the numbers in brackets, for example (X), represent the item
numbers of the display and control elements in the illustrations of the front and rear of
the device.
9
10
12
11
13

5
2.2 Intended use
2.2.1 Purpose
The Sutter irrigation pump is indicated to provide sterile isotonic saline solution for improved
procedural site visualization.
2.2.2 Contraindications
No contraindications that apply to the product directly are known at this time. The safety measures
described in Chapter 5 have to be observed in addition.
2.2.3 Side effects
No side effects that apply to the product directly are known at this time. To avoid unintended
effects, the safety measures described in Chapter 5 have to be observed.
2.2.4 Essential performance characteristics
The Sutter CURIS®flow Irrigation pump has no essential performance characteristics.
3Commissioning
NOTE
To avoid unintentional irrigation, the irrigation pump has to be switched off during setup.
Position the CURIS®flow Irrigation pump on a sturdy, horizontal surface.
Alternatively, the CURIS®flow IV pole mounting bracket (REF: 360901) that is part of the delivery
scope can be used to connect the irrigation pump to an IV stand (Ø 15 - 25mm).
To do so, attach the IV pole mounting bracket to
a corresponding IV stand. Then connect the IV
pole mounting bracket to the irrigation pump
using the connection socket (13) on the bottom
of the device. Use the supplied mounting screws
for this purpose.
NOTE
When the IV pole mounting bracket is
mounted on an IV stand, check for tipping
resistance and ensure this is maintained
at all times.
3.1 Setup for use with the corresponding footswitch
Connect the CURIS
®
flow one-pedal footswitch with push-button, available as
an option
(REF: 360115), to the connection socket (9) on
the rear of the
irrigation pump.

6
3.2 Potential equalization connection
Potential equalization is a connection of device housings with good electrical
conductivity. It is intended to ensure that the devices consistently maintain the
same electrical potential, even in case of an electrical defect. For optional
potential equaliz
ation, use the potential equalization connection (11).
Push the potential equalization cable on firmly until it snaps into place. The
potential equalization cable is not included in the scope of delivery.
3.3 Mains connection
WARNING
To exclude the risk of electric shock, this device may only be connected
to a mains network with protective conductor.
The device is equipped with a multi
-
voltage power supply. It can be operated in
the
following voltage range without switching:
100 – 240 V AC, 50 / 60 Hz
Connect the mains cable to the connection socket (10) on the rear of the device
and connect the other end of the mains cable to an outlet.
For the all
-
phase, full disconnection of the device in case of danger, either the
connection socket on the device or the outlet where the mains cable is plugged
in should be left accessible.
No special measures are required to take the device out of operation.
NOTE
Inspect the mains cable and plug for proper function and damage before
each use.
3.4 System start and self-test
Turning the device on and off:
The device is turned on and off
by using the power switch on the front of the device (1).
When it is switched on, an automatic self-
test is performed. The display (2) and LED
status indicator (5) light up briefly. When the self-
test has successfully completed, the
LED status indicator (5) turns off and the last used flow setting is displayed, indicating
that the irrigation pump is operational.
An error in the self-test sequence indicates a device defect, the LED status indicator (5)
lights up red and the error message “
E
” is shown on the display.
See “Error display and
troubleshooting” in Chapter 7.
NOTE
The factory flow setting “0” is shown the first time the device is powered up.