Cooper Surgical K-Systems G210 InviCell User manual

Document K32904 | Issue: 6 | Date: November 26, 2018 | DRF: 4681 only
User Manual
Models: InviCell Incubators
G210 InviCell
CO2/O2 Incubator

Contents
Section 1 - Preface 6
Section 2 - Safety 7
Safety and Reliability 7
Cautions 8
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions 9
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 9
Symbols 11
Section 3 - Installation 13
Before Installation 13
Placement 13
Section 4 - Intended Use 14
Applicable Part Numbers 14
Significant Performance Characteristics 14
Operation Principle 14
User Profile 14
Operating Environment 14
Dish Inserts 15
Chamber Heating 15
Chamber Lid 15
Preparation Chamber 15
Section 5 - Product Overview 16
Main Components 16
Supplied Accessories for G210 InviCell Standard 17
Accessory Order Codes 18
Specification Table 19
Section 6 - G210 InviCell Plus 20
Section 7 - Set-up 21
Gas Supply 21
Factory Settings 21

Contents
Section 8 - Basic Operation 22
Touchscreen Menu 22
Main Menu 23
Advanced Menu 23
Chamber Information 24
Edit Chamber Information 24
Log 25
Setpoint 25
Changing the Temperature Setpoint 26
Changing the Gas Setpoint 26
Section 9 - Settings 27
Changing the Date and Time 27
Ethernet Settings 28
Changing the Preparation Chamber Settings 28
Changing Language 28
Changing Basal Body Temperature 28
Security Settings 29
Access Levels 30
Edit User 31
Change Password 31
Create A New User 32
Delete User 32
Log Out 32
Lost Password 32
Alarm 33
External Alarm Connector 33
Errors 33
Section 10 - K-Link 34
Starting K-Link 34
Device Connection 34
Measurement Section 35
Alarm Display Section 35

Contents
Graph Section 36
Level Tab 36
Pressure Tab 37
Daily Average Tab 37
Warning Tab 38
Mail Tab 38
Service Tab 39
Section 11 - Troubleshooting 40
Heating System 40
CO2Gas Regulator 40
O2Gas Regulator 41
Gas Consumption 41
Touchscreen 41
Section 12 - Maintenance 42
Periodic Cleaning 42
Disinfection 42
Sterilizing the Dish Inserts 42
Validation Check 43
Gas Sample Port 44
Chamber Lid Plug 45
Verification of Gas Concentration in Chambers 45
Temperature Calibration 46
Section 13 - Service 47
Service Plan 47
On-screen Prompts 47
Replacing the Origio Gas Line Filter 48
Disposal of the Origio Gas Line Filter 48
Section 14 - Disposal and Recycling 49
Environmental Protection for Disposal of the Product 49
Recyclable Components 49
Section 15 - Warranty Information and Limits on Liability 50

Preface
1
5
Section 16 - Returning Product To CSI for Repair 51
Customer Service Contact Details: 52
US Only Customers Contact Details: 52

Preface
1
6
Section 1 - Preface
Thank you for choosing a K-Systems product. We hope you will be happy with your G210 InviCell.
At CooperSurgical, we strive to provide the very best products and solutions for human IVF and the
G210 InviCell is designed to provide optimum conditions for your embryos during long-term culture.
For optimal use of your G210 InviCell, please read and follow the instructions in this User Manual.
The incubator should be operated by trained personnel only. All sections of this manual should be
read and understood fully before any operation of the incubator. If the operator is unsure of any of
the information contained in this manual they should contact Customer Services or an appointed
representative before attempting to use this equipment. Keep these instructions close to the device
as this will ensure having easy access to the safety instructions and important information.
In no event does CooperSurgical assume the liability for any technical or editorial errors of commission,
or omission; nor is liable for direct, indirect, incidental, or consequential damages arising out of the
use or inability for you to use this manual.
The information in this manual is current at the time of publication. Our commitment to product
improvement requires that we reserve the right to change equipment, procedures and specifications
at any time. This user manual belongs with the G210 InviCell incubator and should be passed on with
the incubator if relocated to another facility.
© This manual is protected by copyright, all rights reserved, and no part hereof may be photocopied
or reproduced in any form without the prior written consent of CooperSurgical.
95 Corporate Drive
Trumbull
CT 06611
USA
CooperSurgical is a registered trademark of CooperSurgical, Inc.
K-Systems is a CooperSurgical brand.
©2018 CooperSurgical, Inc.

Safety
7
2
Section 2 - Safety
Safety and Reliability
Please read this manual carefully and follow the instructions to ensure that the system will work safely
and reliably. Safety is the responsibility of the laboratory. Risk assessment and working practices
should comply with local regulatory policies.
Warnings
WARNING: Use only 100% pure CO2and 100% pure N2gas. Use of other gases could
result in serious injury, depending on the gas connected.
DO NOT: disassemble or modify any part of the G210 InviCell, or substitute any
component for any other. Doing so may result in damage to samples. This voids the
warranty and/or service contract.
WARNING: To avoid the risk of electric shock, this equipment must only be connected
to a mains supply with protective earth.
WARNING: Not to be used in a patient environment.
WARNING: Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and result in improper operation.

Safety
8
2CAUTION
• DO NOT use the incubator if ShockWatch or TipNTell has been triggered or if the package is
damaged.
• Read and understand the manual completely before use. Keep the manual close to
the unit.
• Never use or handle this unit in ways other than specified in this manual. Your safety may be at
risk and the unit may get damaged.
• Never try to move the unit without consulting a person authorized by CooperSurgical.
• Never use the unit if the alarm system of the device has issued a failure message and the cause
of the failure has not been identified.
• Protect the power cord from being damaged or being restricted in any way. Unplug the power
cord from the wall socket or at the rear of the instrument to disconnect the mains supply.
• Make sure that CO2and N2gas supply pressures are maximum 1.0 bar and not below 0.5 bar.
• Always keep the red cap on unused gas inlets at the back of the unit and the protection cap on
the Sample Port placed behind the Preparation Chamber.
• Never use the unit without an original Origio Gas Line Filter.
• DO NOT expose the filter to liquids. Change filters that have been exposed to liquids.
• DO NOT leave lids open for more than 20 seconds.
• DO NOT use the unit at ambient temperatures exceeding 30°C. Ambient temperature above
30°C will compromise the incubation process. The relative humidity must not exceed 75% (non-
condensing).
Cautions

Safety
9
2
Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions
The G210 is intended for use in the electromagnetic environment specified below. The customer or the user of
the G210 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR11 Group 1
The G210 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR11 Class A – Complies The G210 is suitable for use in all establishments other than domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A - Complies
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Class A - Complies
Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity
The G210 is intended for use in the electromagnetic environment specified below. The customer or the user of
the G210 should assure that it is used in such an environment.
IMMUNITY Test IEC 61326-1
Test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+ 2, 4 kV contact
+ 2, 4, 8 kV air
+ 2, 4 kV contact
+ 2, 4, 8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30 %.
Electrical fast transient/
burst
IEC 61000-4-4
Not applicable Not applicable
Surge
IEC 61000-4-5
Not applicable Not applicable
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Not applicable Not applicable
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial environment.
USA Only
Compliance with the emissions requirements of CISPR 22 Class A requires the following warning: “This is a class
A product. In a domestic environment this product may cause radio interference in which case the user may be
required to take adequate measures.”

Safety
10
2
IMMUNITY Test IEC 61326-1
Test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Not applicable
3 V/m
80 MHz to 1000 MHz
3V/m
1400 MHz to 2000 MHz
1V/m
2000 MHz to 2700 MHz
Not applicable
3 V/m
3V/m
1V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the G210, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter
Recommended separation distance
d = [ 3,5 ] √P
3
d = [ 3,5 ] √P 80 MHz to 800 MHz
3
d = [ 7 ] √P 800 MHz to 2,5 GHz
3
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.
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 G210 is used exceeds
the applicable RF compliance level above, the G210 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the [System
Name here].
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Safety
11
2
Symbol Meaning
WARNING: Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION: Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury. It may also be used
to alert against unsafe practices.
Consult the User Manual for information needed for proper use of
the device.
Manufacturer
Date of manufacture
Waste electrical and electronic equipment
• CooperSurgical, and its distributors within the European Union
and associated states, have taken the necessary steps to comply
with the directive 2012/19/EU on waste electrical and electronic
equipment (WEEE).
• The instrument, when reaching its end of life, must be collected
and recycled separately from other waste according to national
requirements. Environmental implications: WEEE contains
materials that are potentially hazardous to the environment and
to human health (see page 49).
S
N
Serial Number
REF
Catalog Number
This equipment must be protectively earthed
Warranty label
Symbols
Glossary ISO 15223-1:2016

Safety
12
2
Symbol Meaning
Ethernet
Sample Port Sample Port
GAS (MAX 1 BAR) Gas Inlets CO2/N2
Static Sensitive (ESD)
Fuse
Caution: US Federal law restricts this device for sale to or on the order
of a licensed healthcare practitioner.
Humidity limitation for storage and use
Non-condensing
Temperature limit for storage and use
Max 1 week at 50°C
only
95%
5%
50°C
-5°C

Installation
13
3
Section 3 - Installation
Installation of the G210 with InviCell should be carried out by a CooperSurgical technician or other
authorized personnel. Incorrct installation could result in overall poor performance.
The G210 InviCell is designed as a stationary unit and, therefore, not to be moved once it has been
installed. If the incubator needs to be relocated, please contact Customer Service.
Before Installation
This incubator is transported in a crate and we recommend you inspect its delivery. If the ShockWatch
or TipNTell has been triggered, inform Customer Service
Check the contents to ensure all parts listed on the packing list are present.
Placement
The G210 InviCell should be placed on a level, secure surface, away from heaters, coolers,
air-conditioning outlets, mists, splash and direct sunlight. Allow 10cm of clearance on all sides to allow
adequate ventilation.
Allow the G210 to acclimatize for two hours before installation.
To maintain a device setpoint between 35-40°C the preferred ambient temperature should be
between 20-30°C. DO NOT use the incubator at ambient temperatures exceeding 30°C as this may
compromise the incubation process.
This unit is designed for use at altitudes under 2,000 meters.
HANDLE WITH CARE
WARNING
RED INDICATES ROUGH HANDLING.
IF RED, NOTE ON THE BILL OF LADING
AND INSPECT PRODUCT
PRODUCT OF MEDIA RECOVERY
MODEL: L-65 (25g)
MADE IN THE USA
www.shockwatch.com 1.800.527.9497
MADE IN THE U.S.A
BLUE BEADS IN
ARROW INDICATES
CONTAINER WAS
TIPPED OR
MISHANDLED
TELL
TIP
CAUTION
• Installation of the unit should only be performed by an authorized CooperSurgical Service
Technician.
• Never block any of the ventilation holes on the unit.
• Make sure that all devices emitting electromagnetic radiation are kept at a reasonable distance
from the unit in order to avoid any potential interferences.
• Make sure the power circuits used are intended for medical equipment.
• Make sure there is sufficient access to the device for ease of disconnection if required.

Intended Use
14
4
Section 4 - Intended Use
To provide an environment with controlled temperature at or near body temperature and gas level
(CO2, O2and N2), for the development of human gametes and embryos during in vitro fertilization
(IVF) treatment.
Applicable indications for use are subject to the regulations of the country into which the device
is sold and also the availability of the G210 InviCell for clinical use is dependent on the regulatory
approval status of the incubator within that country.
Applicable Part Numbers
Order Code Description
K59700 InviCell Standard Incubator
K61500 InviCell Incubator (Field Upgradable)
Significant Performance Characteristics
The incubator has been developed and optimized for gametes and embryos cultured with an overlay
of either paraffin or mineral oil. Each chamber is designed to contain dishes from one patient only.
Operation Principle
The fertilized egg (zygote) is cultured for up to 6-7 days in a growth medium in the incubator with
a controlled environment (temperature and CO2/O2). It is then implanted in the same or another
woman’s uterus, with the intention of establishing a successful pregnancy.
User Profile
Atrainedhealthprofessional,whohastheappropriate assisted reproductiontechnologiesqualifications.
Only qualified personnel trained in using the G210 InviCell should operate the incubator.
CAUTION: 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 stated in this User Manual.
Operating Environment
To be used at ambient temperature in a medical environment, clinic or hospital laboratory under
normal working conditions.

Intended Use
15
4
Ensure the culture dishes
are placed securely in the
correct milled grooves of
the Dish Inserts.
1
23
Dish Inserts
The chambers should only be fitted with special Dish Inserts (1), that allow safe placement of standard
culture dishes (Falcon, Nunc, Vitrolife).
Chamber Heating
Each chamber is heated with K-Systems unique non-inductive EM Neutra™ heating system, which
provides a uniform heat distribution and ensures there is no electro-magnetic field around the embryos/
gametes. All chambers have their own individual sensors to ensure stable temperatures at all times
and unidirectional gas flow across the chambers ensures even gas distribution in each chamber.
Chamber Lid
Each lid has a sensor that, when opened, will disconnect the gas flow to minimize ambient air entering
the chamber. The gas flow restarts immediately after closing the lid.
The silicone plugs (2) in the lid of each chamber are for the collection of gas samples. These plugs
should be replaced when penetrated a maximum of 5 times.
Preparation Chamber
The Preparation Chamber (3) is intended to be used for the equilibration and heating of pre-filled
culture dishes with an oil overlay or flask of oil.
The Preparation Chamber also has a temperature sensor which will disconnect the gas flow when the
lid is opened, to minimize the ingress of ambient air. The gas flow restarts immediately after closing
the lid.
Gas flow to the Preparation Chamber can be disconnected by using the on/off button in system
settings (see page 28).

16
5
Product Overview
Section 5 - Product Overview
Main Components
Components
1 Incubator Chambers
2 Touchscreen
3 Preparation Chamber
4 Origio Gas Line Filter
4
2
3
1
G210 InviCell models - front view
G210 InviCell models - raised top section

17
5
Product Overview
5
7
On base
of unit
6
89 10
Supplied Accessories for G210 InviCell Standard
• 1 x Origio Gas Line Filter
• 2 x HEPA Inline Filter for input gas supply
• 10 Dish Inserts for Nunc®, Falcon®or Vitrolife®
• 2 x Silicone Tube Sealing Rings & Silicone Tube (3m)
• Gas sampling coupling
• 1 power cord
• 1 LAN cable (3m)
• 1 packet of Chamber Lid plugs (10 pieces)
• 1 USB drive containing K-Link software
Components
5 Product label
6 Mains connection with fuse
7 Ventilation holes
8 Gas inlet connectors
9 Alarm output
10 Ethernet connector**
**External computing devices connected to the Ethernet on the unit must only be Limited Power
Source and SELV circuit according to the standards IEC/UL 60950-1.
G210 InviCell Standard Model - back view

18
5
Product Overview
Accessory Order Codes
Order Code Description
23063-1 Falcon Dish Inserts 1 pc
23064-1 Nunc Dish Inserts 1 pc
22410-1 Nunc Dish Inserts 10 pc
23069 Vitrolife Dish Inserts 1 pc
23070-1 Vitrolife Dish Inserts 10 pc
22412-1 5 x Nunc Dish Inserts and 5 x Falcon Dish Inserts
23071-1 5 x Nunc Dish Inserts and 5 x Vitrolife Dish Inserts
23072-1 5 x Vitrolife Dish Inserts and 5 x Falcon Dish Inserts
ULTRA-001 Origio Gas Line Filter
53830 HEPA Inline Filter
59922 Lid Plugs, bag of 10
59901-1 Lid Seal for culture chambers
59902-1 Lid Seal for Preparation Chamber
59688 Gas sampler coupling
11103 G100 Gas Analyzer
11006 Solid Temperature Sensor (use with K-Systems F100 Thermometer)
59655 XLR6 Receptacle Connector
32904 User Manual

19
5
Product Overview
Specification Table
Criteria Specification
Overall dimensions, (L x W x H) 860mm x 550mm x 180mm
Weight 53kg maximum
Temperature range 35 – 42°C
User interface Touchscreen
User interface functions Digital temperature readout, data logger, temperature
setpoint, calibration, warning for next service
Connections Mains, CO2gas, N2gas, Sample port, Ethernet, Alarm
Alarms Visual and audible alarm for out of range temperature and gas
Filter (HEPA/ VOC) Origio Gas Line Filter
IP class IP30
Overvoltage category Transient overvoltage II
Pollution degree rating for electrical
equipment 2
Power specifications 100 – 240 VAC
Max consumption 270W
Voltage L/N/PE AC, 100 - 240VAC Class 1 type B
Frequency 50/60 Hz
Current 3.2A
Mains supply voltage fluctuations Up to +/-10 % of the nominal voltage
Fuses 100 - 240V UL Listed
Mains connection T2.7AL
Ambient conditions
Working temperature and humidity 20 – 30°C. Less than 75% RH (non-condensing)
Transport and storage temperature
and humidity
5 – 50°C. Less than 95% RH (non-condensing)
Maximum one week at 50°C

20
6
G210 InviCell Plus
Section 6 - G210 InviCell Plus
G210 InviCell Plus is not currently available for sale in the USA.