Cooper Surgical K-Systems R65 User manual

[phone] | [email protected] | fertility.coopersurgical.com
CooperSurgical, Inc.
95 Corporate Drive, Trumbull, CT 06611, USA
Document K33118UM(2) | DRF 5570 | 24 November 2020
1639
K-Systems®
R65 Trolley
User Manual

CONTENTS
SECTION 1 – PREFACE 1
Copyright 1
SECTION 2 - SAFETY WARNINGS 2
Glossary of Safety/Information Symbols 2
SECTION 3 - PRODUCT OVERVIEW 3
Unpacking and Inspection 3
Accessories 3
Optional Equipment 3
Intended Use 4
General Description 4
SECTION 4 - BASIC OPERATION 5
Features and Operation 5
Assembling the R65 5
Connection to the Mains 5
Start of Apparatus 5
Keyboard Functions 5
Operating the Heated Area 5
Temperature Setting and Control 6
Combination Keys 6
Temperature Alarm 7
Warming Up 7
Safety barrier 7
SECTION 5 - MENU FUNCTION 8
Overview of Options 9
Unit 10
RS232 11
Tn-t/Tn-b 12
INT.T 12
TI.St 13
ContentsCooperSurgical, Inc.

St.St 14
Heat 15
A-ST 16
Hour 17
Rest 18
SECTION 6 - CARE AND MAINTENANCE 19
Cleaning 19
Preparation at the Point of Use 19
Periodic Cleaning 19
Disinfection 19
Drying 19
Calibration 19
Disposal of electrical and electronic equipment. 20
SECTION 7 - TROUBLESHOOTING 21
SECTION 8 - TECHNICAL DATA 22
SECTION 9 - WARRANTY INFORMATION AND LIMITS ON LIABILITY 23
SECTION 10 - RETURNING PRODUCT 24
Returned Goods Policy 24
Customer Service Contact Details 25
US Only Customers Contact Details 25
SECTION 11 - CUSTOMER SERVICE CONTACT INFORMATION 26
European Service Representatives 26
US Service Representatives 26
CONTENTS
CooperSurgical, Inc.Contents

Section 1
1
1
CooperSurgical, Inc. Preface
SECTION 1 – PREFACE
Copyright
This manual contains information that is subject to copyright. All rights reserved. This manual
should not be photocopied, otherwise copied or distributed, completely or in part, without the
approval of CooperSurgical, Inc.
Users of K-SYSTEMS CooperSurgical, Inc products should not hesitate to contact us if there
are any unclear points or ambiguities in this manual.
CooperSurgical, Inc.
Phone: [phone]
International Phone: [phone]
[email protected]
fertility.coopersurgical.com
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611, USA
If the equipment is used in a manner not specified by this manual, the safety of the
user may be at risk and the equipment may be damaged. Always use the equipment
as outlined in this instruction manual.

Section 2
Safety Warnings
2
2
CooperSurgical, Inc.
SECTION 2 - SAFETY WARNINGS
Glossary of Safety/Information Symbols
Symbol Meaning
In accordance with Low Voltage Directive 2014-35-EU
Consult instructions for use - coopersurgical.com
Hard copies available on request
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a variety of
reasons, be presented on the medical device itself.
Manufacturer
Date of manufacture
Catalogue or Part number
Serial number
Do not dispose of product with normal waste. Dispose of in accordance with the EU
WEEE Directive. (See Care and Maintenance section.)
This way up
Fragile, handle with care
Stacking limited to 3 units
Keep dry
0120
CooperSurgical.com
3
Source: ISO 15223-1 and ISO 60601-1

Section 3
3
Product Overview
3
CooperSurgical, Inc.
SECTION 3 - PRODUCT OVERVIEW
Unpacking and Inspection
• Unpack the equipment.
• Check the packing list to insure all accessories are there.
• Examine the packing material carefully for separately packed items.
• Check the warming plate for external surface damage.
• Check that the display is not broken or damaged.
Accessories
Standard Accessories
PSU External power supply
Order code: 24009
Mains Cable
Order code: 1212807
Optional Equipment
Optional equipment consists of a range of warming blocks. Please contact your local CooperSurgical
distributor or CooperSurgical, Inc. for details about the full range of warming blocks.
Examples of dierent types of warming blocks
Warming block B01
Holds seven tubes Ø17mm
Falcon 352001
Order code: 26001
Warming block B06
Holds twelve tubes of Ø12mm
Falcon 352003
NUNC 343923
Order code: 26006
Warming block B09
Holds two tubes of Ø17mm
Falcon 352095
Order code: 26018
Warming block B28
Holds one 4-well dish
NUNC 176740/14444
Order code: 26029
Warming block B30
Holds five flushing syringes
of 20 ml/Ø22.5mm
Order code: 26013

Section 3
Product Overview
4
3
CooperSurgical, Inc.
Intended Use
The K-SYSTEMS R65 Trolley is intended to maintain the temperature of gametes and/or embryos
during assisted reproductive technology (ART) treatments.
General Description
The stainless steel surface maintains a preset temperature in the range ambient to max 42°C. The
temperature is electronically controlled and can be read on the display in increments of 0.1°C.
RS 232
connector
(No longer
supported)
Heated
surface
PSU
socket
Heated
drawer
External
power supply

Section 4
5
Basic Operation
4
CooperSurgical, Inc.
SECTION 4 - BASIC OPERATION
Features and Operation
Assembling the R65
No assembly needed. Just follow directions below and the unit is now ready for use.
Connection to the Mains
The mains voltage is automatically regulated to the correct level by the mains adaptor (PSU).
Connect the R65 to the mains supply using the enclosed PSU.
Start of Apparatus
To power up the unit, press the Heat ON/OFF button on the keyboard. The display indicates the
current temperature, either on the table plate or in the drawer.
Keyboard Functions
8888
Alarm Heat
ON/OFF
LED Display Set-point Arrow keys
UP/DOWN
Operating the Heated Area
Action Key
Press heat ON/OFF key to show the actual temperature on either the table
plate or in the drawer..
Press arrow UP or arrow DOWN to shift between these temperatures.
Temperature on table plate.
Temperature in drawer.
t37.0
37.0

Section 4
Basic Operation
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CooperSurgical, Inc.
Temperature Setting and Control
The display indicates the average temperature of the surface.
Action Key
Press set-point key until set temperature is shown.
Press and hold set-point key.
While holding the set-point key in, press either the arrow UP or arrow
DOWN key to raise or lower the set temperature.
When the desired temperature is reached, let go of the set-point key.
Note: The set-point can be adjusted to a reading between ambient and 49.9˚C.
Combination Keys
Action Key Display
Press alarm and UP key. The keyboard is locked.
Press alarm and UP key. The keyboard is unlocked.
Press Heat ON/OFF and set-point
key.
Switches between temperature and
time.
Press DOWN key and Heat ON/OFF. The heat in the drawer is turned o.
Press DOWN key and Heat ON/OFF. The heat in the drawer is turned back
on.
+
+
+
+
+
+

Section 4
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Basic Operation
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CooperSurgical, Inc.
Temperature Alarm
The temperature alarm indicates too high or too low temperature. The alarm will be activated if
the temperature rises or falls more than 0.5°C from the set point. There will be an acoustic signal
and the red LED light in the alarm key will be activated.
Action Key
Press alarm key to mute the acoustic signal.
Press alarm key once again to bring the signal back on.
Note: The red LED light and the acoustic signal will turn o when the temperature stabilizes to
the set-point level
Warming Up
Warming up from 20.0°C to 37.0°C takes less than 20 minutes under normal conditions. When a
cold item is placed on the heated area it may need up to 30 minutes to stabilise, depending on
the thermal mass of the object and the initial temperature.
Safety barrier
There is a greater heat loss from the edges of the warming plate, and the tolerances cannot be
kept as precisely in these areas. A high accuracy can only be maintained in the centre area of
the warming plate.
Please see picture below:
8 cm
8 cm
13 cm
2.5 cm 9 cm
8 cm
Top view
Our general recommendations:
Dark grey area only: +/- 0,3°C
Light grey area: +/- 0,8°C
White area: No heat

Section 5
Menu Function
8
5
CooperSurgical, Inc.
SECTION 5 - MENU FUNCTION
The user can access a number of advanced functions via the menu.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The first option “UNIT” will appear in the display.
Press UP/DOWN key to navigate within the Menu.
While holding the set-point key in, press either the
arrow UP or arrow DOWN key to change values
within the options.
Press and hold UP+DOWN key for 3 seconds again
to exit the menu.
The menu consists of the 11 options listed in the Overview of Options digram. For further detail
see the description on the following pages.

Section 5
9
Menu Function
5
CooperSurgical, Inc.
Overview of Options
S-1
S-2
Send }Version 3
˚C
˚F
UNIT
On
Off
RS232
+0.05
+0.05
-0.05
Tn-t
+0.1
-0.1
INT.T
M + 1
H + 1
Ti.St
M + 1
H + 1
St.St
On
Off
HEAT
On
Off
A-St
On
Off
HOUR
REST ----
Software version
Calib. value
-0.05
Tn-b
Calib. value

Section 5
Menu Function
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CooperSurgical, Inc.
Unit
In the UNIT option the displayed temperature unit can be set to either degrees Celsius or
Fahrenheit.
Follow these steps to navigate in the UNIT option.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The menu “UNIT” will appear in the display.
Press and hold set-point key to change values.
While holding the set-point key in, press either
the arrow UP or arrow DOWN key to select the
required type of unit.
When the required type has been selected let go
of the set-point key.
Press and hold UP+DOWN key for 3 seconds to
exit the menu.

Section 5
11
Menu Function
5
CooperSurgical, Inc.
RS232
The RS232 output was intended for data-logging and third-party monitoring, but is no longer
supported by CSI. The steps below are provided for reference only.
Follow these steps to navigate in the RS232 option.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The option “UNIT” will appear in the display
Press DOWN key until the option “RS232” appears
in the display
Press and hold set-point key to change values.
While holding the set-point key in, press either the
arrow UP or arrow DOWN key to select between
“ON” and “OFF”.
“OFF”: The RS232 function is turned o.
“ON”: Data is send once every two seconds.
When the required setting is activated, let go of the
set-point key
Press and hold UP+DOWN key for 3 seconds to exit
the menu.
Data logging the temperature valves during use:
Note: Connect the RS232 cable before start.
Follow the steps in the table above and choose “ON”. Choose one of the settings to get the
required data
S-1 Sends the data for the last one hour.
S-2 Sends the data for the last two hours
send Sends the data for the last five hours.
Note: The use of this function warrants extra equipment software (Ver. 3) and on some base
models addition of a Serial PCB. The parameters on or o will not aect normal usage when
serial communication is not connected.
r232

Section 5
Menu Function
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CooperSurgical, Inc.
Tn-t/Tn-b
The Tn-t/Tn-b option is for calibration of the displayed temperature of the table top (Tn-t) and the
drawer (Tn-b). If there is an oset between the value on the display and any measurements made
with a high precision external temperature sensor, this can be corrected. The new temperature
reading will be kept as the displayed value with temperature controlling conducted on this basis.
Follow these steps to navigate in the Tn-t/Tn-b option.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The menu “UNIT” will appear in the display.
Press DOWN key until the option “Tn-t/Tn-b”
appears in the display.
Press and hold set-point key to change values.
While holding the set-point key in, press either the
arrow UP or arrow DOWN key to select the value
of temperature.
When the required temperature has been selected
let go of the setpoint key.
Press and hold UP+DOWN key for 3 seconds to exit
the menu.
Caution: Any change in the factory set calibration should always be based on very certain
temperature measurements. CooperSurgical only recommend the use of a high quality PT-100
sensor that is calibrated with the precision instrument used for measuring according to the
manufacturers specifications. Ensure an optimal contact between the sensor and the place
measured. Use only a sensor type that is correct for the purpose, and which has the correct
size. If in doubt contact your local CooperSurgical distributor.
INT.T
The INT.T (Integral Time) option is for changing the base value for the PID controller. This should
not be attempted by unauthorised persons. If set at a dierent level the controlling principle will
be aected.
From the factory it is set to a closely calculated value specific for the model.
tn-t
CAUTION: Do not change the value here. If by mistake any changes are made or
doubts occur if the value are correct please set the REST function in the menu for
the restore of the defaults.

Section 5
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Menu Function
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CooperSurgical, Inc.
TI.St
The Ti.St (Time Set) option is for setting the time.
Follow these steps to navigate in the Ti.St option.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The option “UNIT” will appear in the display.
Press DOWN key until the option “Ti.St.” appears
in the display.
Press and hold set-point key to change values.
While holding the set-point key in, press either the
arrow UP to change minutes or arrow DOWN key
to change the hour.
Press and hold UP+DOWN key for 3 seconds to exit
the menu.

Section 5
Menu Function
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CooperSurgical, Inc.
St.St
The St.St (Start Set) option is the timer function for the heat.
By using this option, time can be saved as the R65 can be ready for use before procedures start
in the morning.
Note: This function will only work correctly if the clock is set.
Follow these steps to navigate in the St.St option.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The menu “UNIT” will appear in the display.
Press key DOWN until the option “St.St” appears
in the display.
Press and hold set-point key to change values.
While holding the set-point key in, press either the
arrow UP to change minutes or arrow DOWN key
to change the hour.
When the time is set, let go of the set-point key
Press and hold UP+DOWN key for 3 seconds to exit
the menu.
Note: If the function Heat is set, a dot will light up in the right side of display.
St.St is connected with HEAT. It must be chosen when the timer starts. To turn the heater on,
please see “Heat” on page 15
WARNING: Always make sure when the timer function is being used, that the heated
area is clear of any objects that might be damaged by the heat or adversely aected
by it in way. Caution should always be exercised when a heated area is turned on
without any supervision.

Section 5
15
Menu Function
5
CooperSurgical, Inc.
Heat
The HEAT option is used for the heater to turn on at a certain time.
Note: This function only works in conjunction with St.St. If St.St is set to 8.00 and heat function
is on, the heater will automatically turn on at 8.00 using 24 hour clock.
Follow these steps to navigate in the HEAT menu.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The first menu “UNIT” will appear in the display.
Press DOWN key until the option “HEAT” appears
in the display.
Press and hold set-point key to change values.
While holding the set-point key in, press either
arrow UP or arrow DOWN key to select between
“ON” and “OFF”.
When the required setting is activated, let go of the
set-point key.
Press and hold UP+DOWN key for 3 seconds to exit
the menu.
Note: A dot will turn on in the right side of display, indicating that the Heat function is active.
hEAt

Section 5
Menu Function
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CooperSurgical, Inc.
A-ST
The A-St (Automatic Start) option is used to repeat the timer (St.St) function every day of the
week.
Note: This function works in conjunction with St.St and HEAT. If St.St.is set to 8.00 and heat
function is on, the heater will automatically turn on at 8.00 every day.
Follow these steps to navigate in the A-st option.
Action Key Display
Press and hold UP+DOWN key for 3 seconds to
enter the menu.
The first menu “UNIT” will appear in the display.
Press DOWN key until the option “A-st” appears in
the display.
Press and hold set-point key to change values.
While holding the set-point key in, press either
arrow UP or arrow DOWN key to select between
“ON” and “OFF”.
When the required setting is activated, let go of the
set-point key.
Press and hold UP+DOWN key for 3 seconds to exit
the menu.
Note: If this function is set to ‘on’ the heat function will be repeated every day, but if A-St function
is set to ”o” the heat function will only be activated one time.
A-St