G185 Bench Top Incubator Instruction Manual Issue 13

Contents Section 1 - Preface1 Section 2 - Safety2 Safety and Reliability2 Warnings2 Cautions3 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

4

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

4

Section 3 - Installation 

8

Placement 8

Section 4 - Intended Use 9 Applicable Part Numbers9 Significant Performance Characteristics9 Operation Principle9 User Profile 9 Operating Environment9 Product Description

10

Dish Inserts 10

Section 5 - Product Overview11 Main Components11 Supplied Accessories for G185 Incubator12 Accessory Order Codes12 Technical Specifications13

Section 6 - G185 SensorTech 15 External pH Monitoring15 External Temperature and CO2 Monitoring16

Section 7 - Set-up17 Gas Supply17 Factory Settings17

Contents Section 8 - Basic Operation

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User Interface 18 System on Standby19 Switching the Unit ON19 Switching the Unit OFF (Standby Mode)20 Activating the Heat and Gas Controls20 Keyboard Lock21

Section 9 - Settings23 Advanced Function

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Menu Items24 Front Chamber Keys28 Timer28 Clock29 Alarm Switch for External Monitoring System29 Writing Pads for Chamber Lids and Penholder30

Section 10 - Data Logger 

31

System Requirements 

31

Software Installation

31

Connecting To PC

31

Activating Data Log Function for PC

32

Starting The Data Logger Software

33

Connecting Multiple Incubators

33

Zoom In

34

Zoom Out

34

Alignment35 Temperature and Gas level

35

Gas Flow and Pressure

36

The Daily Average 

36

Warnings Menu

37

Mail38 Log Files

39

Contents Section 11 - Troubleshooting40 Heating System40 CO2 Gas Regulation

40

O2 Gas Regulation

41

Display42 Keyboard42

Section 12 - Maintenance 43 Periodic Cleaning 43 Disinfection

43

Sterilizing the Dish Inserts 43 Validation Check 44 Gas Calibration

44

Via the Gas Sample Port44 Via Gas Chamber Lids45 Temperature Calibration

46

Section 13 - Service 48 Service Plan48 Replacing the Coda Inline Filter49

Section 14 - Disposal and Recycling 50 Environmental Protection for Disposal of the Product50 Recyclable Components50

Section 15 - Warranty Information and Limits on Liability51 Section 16 - Returning Product To CSI for Repair52 Customer Service Contact Details:53 US Only Customers Contact Details:53

Preface

1 Section 1 - Preface

Thank you for choosing a K-Systems product. We hope you will be happy with your G185. At CooperSurgical, we strive to provide the very best products and solutions for human IVF and the G185 is designed to provide optimum conditions for your embryos during long-term culture. For optimal use of your G185, 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 you are unsure of any of the information contained in this manual then you 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 G185 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

EC REP

EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands

CooperSurgical is a registered trademark of CooperSurgical, Inc. K-Systems is a CooperSurgical brand. ©2020 CooperSurgical, Inc.

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Safety

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.

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Warnings WARNING: Use only 100% pure CO2 and 100% pure N2 gas. Use of other gases could result in serious injury, depending on the gas connected DO NOT: Disassemble or modify any part of the G185, 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

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Safety Cautions CAUTION

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3

•

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 Customer Service

•

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 CO2 and N2 gas supply pressures are not above 1.0 bar and not below 0.5 bar

•

Always keep the red caps on unused gas inlets and the sample port at the back of the unit

•

Never use the unit without an genuine Coda Inline Filter

•

DO NOT expose the filter to liquids. Change filters that have been exposed to liquids

•

DO NOT leave lids open for more than 10 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% (noncondensing)

Safety Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The G185 is intended for use in the electromagnetic environment specified below. The customer or the user of the G185 should assure that it is used in such an environment. Emissions test RF emissions CISPR11 RF emissions CISPR11 Harmonic emissions IEC 61000-3-2

Compliance

Electromagnetic environment - guidance

Group 1

The G185 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.

Class A – Complies Class A - Complies

2

The G185 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.

Voltage fluctuations/ flicker emissions Class A - Complies IEC 61000-3-3

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The G185 is intended for use in the electromagnetic environment specified below. The customer or the user of the G185 should assure that it is used in such an environment. IEC 61326-1

Compliance level

Electromagnetic environment guidance

+ 2, 4 kV contact

+ 2, 4 kV contact

+ 2, 4, 8 kV air

+ 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 Not applicable IEC 61000-4-4

Not applicable

IMMUNITY Test

Test level

Electrostatic discharge (ESD) IEC 61000-4-2

Surge IEC 61000-4-5

Not applicable

Voltage dips, short interruptions and voltage variations on power Not applicable supply input lines

Not applicable

Not applicable

IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical commercial environment.

IEC 61000-4-8

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Safety The G185 is intended for use in the electromagnetic environment specified below. The customer or the user of the G185 should assure that it is used in such an environment. IMMUNITY Test

IEC 61326-1 Test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the G185, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter

2

Recommended separation distance

Conducted RF

Not applicable

Not applicable

d = [ 3,5 ] √P

IEC 61000-4-6

3

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 1000 MHz 3V/m

3 V/m

3V/m

d = [ 3,5 ] √P 3 d = [ 7 ] √P

2000 MHz to 2700 MHz

1V/m

800 MHz to 2,5 GHz

3

1400 MHz to 2000 MHz 1V/m

80 MHz to 800 MHz

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. 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 G185 is used exceeds the applicable RF compliance level above, the G185 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]. a

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b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Safety 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

2

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 50)

SN

Serial Number

REF

Catalog Number

Warranty label

6

Safety Symbol Sample Port

Meaning Sample port

2 GAS (MAX 1 BAR)

Gas Inlets CO2/N2

Static sensitive (ESD)

2797

EC REP 95%

30°C

7

Authorized Representative in the European Community

Humidity limits for storage Non-condensing

5%

-10°C

In accordance with Annex II of the European Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC

Temperature limits for storage

Installation

Section 3 - Installation Installation of the G185 should be carried out by a CooperSurgical Service Technician or other authorized personnel. Incorrect installation could result in overall poor performance. The G185 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.

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www.shockwatch.com 1.800.527.9497

WARNING MADE IN THE USA

TIP TELL

BLUE BEADS IN ARROW INDICATES CONTAINER WAS TIPPED OR MISHANDLED

MADE IN THE U.S.A

Check the contents to ensure all parts listed on the packing list are present.

HANDLE WITH CARE PR

RED INDICATES ROUGH HANDLING. IF RED, NOTE ON THE BILL OF LADING AND INSPECT PRODUCT

OD UC T OF ME DI A

RE CO VE RY

MODEL: L-65 (25g)

Placement The G185 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 G185 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.

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

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Intended Use

Section 4 - Intended Use To provide an environment with controlled temperature at or near body temperature and gas level (CO2, O2 and 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 G185 for clinical use is dependent on the regulatory approval status of the incubator within the country.

Applicable Part Numbers Order Code

4

Description

K22400 - 110 K22400 - 230

Standard Incubator

K22200 - 110 K22200 - 230

SensorTech Incubator

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 A trained health professional, who has the appropriate assisted reproduction technologies qualifications. Only qualified personnel trained in using the G185 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.

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Intended Use Product Description The G185 is composed of 10 separate culture chambers (2) and one larger warming chamber (3). The 10 culture chambers are exposed to both heat and gas mixtures while the Dry Bath Chamber is exposed only to heat. The gas is constantly cleaned for particles, volatile organic compounds and bacteria by circulation through a HEPA and VOC filter. The CO2 concentration is monitored by using a CO2 sensor and the O2 level is monitored by an O2 sensor placed in the gas mixing chamber (built inside the incubator).

Dish Inserts The chambers should only be fitted with special Dish Inserts (1), that allow safe placement of standard culture dishes (Falcon, Nunc, Vitrolife). Ensure the culture dishes are placed securely in the correct milled grooves of the Dish Inserts.

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2

3

1

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Product Overview

Section 5 - Product Overview Main Components Components

5

1

Incubator Chambers

2

User Interface

3

Dry Bath Chamber

4

Coda Inline Filter

5

Product label

6

Mains connection with fuse

7

Gas inlet connectors

8

Alarm output

G185 Standard and SensorTech models front view

1

3

2

G185 Standard model - back view

5 7

8

4 6

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Product Overview Supplied Accessories for G185 Incubator Quantity

Part Number

Description

1

2-02-650

Mains Cable UK Plug 230V

1

2-02-651

Mains Cable Schuko Plug 230V

1

2-02-652

Mains Cable USA Plug 115V

1

2-02-662

Mains Cable Aus/China Plug 230V

2

11066

Silicone Tube (3 metre)

4

22123

Silicone Sealing Rings

2

53830

HEPA Inline Filter

2

59549

Coda Inline Filter

10

57263

Magnetic Pads for Incubator

1

33098

USB (Datalogger Software)

1

57314

USB Converter Cable

5

Accessory Order Codes Order Code

Description

23063-1

Dish Insert Falcon 1 pc

23064-1

Dish Insert Nunc 1 pc

23069

Dish Insert Vitrolife 1 pc

23060-1

Dish Insert Nunc pH Online Sensor (SensorTech models only)

23061-1

Dish Insert Falcon pH Online Sensor (SensorTech models only)

23079

Dish Insert Vitrolife pH Online Sensor (SensorTech models only)

59549

Origio Coda Inline Filter

53830

HEPA Inline Filter

57214

Lid Seal for culture chambers

57272

Lid Seal for Dry Bath Chamber

11103

G100 Gas Analyzer

11006

Solid Temperature Sensor (use with K-Systems F100 Thermometer)

33070

User Manual

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Product Overview Technical Specifications Overall dimensions, (L x W x H)

922 x 570 x 165mm (with filter connected)

Weight

38kg Ambient conditions

Max. ambient temperature during operation

30°C

Min. ambient temperature during operation

20°C

Max. storage temperature

30°C

Min. storage temperature

-10°C Humidity

5

Max. humidity during operation

% R.H.

75, non-condensing

Max. storage humidity

% R.H.

95, non-condensing

Filters VOC Filter Coda Inline Filter

1 pc

Gas Inline Filter, HEPA

2 pcs

high-efficiency, acid-washed, granular-activated carbon combined with HEPA 50mm HEPA disc filter for the protection of internal circuits

Gas and Temperature Temperature Range

From ambient T°- 42.9°C

CO2 range

2 - 10%

O2 range

2 - 20%

Temperature specification (zone) accuracy

Better than +/- 0.3°C deviation

CO2 gas control accuracy

Better than +/- 0.2% average

O2 gas control accuracy

Better than +/- 0.2% average Gas Consumption (typical)

CO2

1.5l/h

N2

7l/h Recovery time

CO2

2 min

O2

4 min Voltage

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Product Overview L/N/PE AC, 100-120VAC 60Hz or 220240VAC 50Hz

Rated Voltage (system) Current Power consumption max.

240 VA Connecting gas

CO2 inlet

1.0 bar/14.5 psi

N2 inlet

1.0 bar/14.5 psi Dish Inserts Suitable for Nunc Ø35mm, Ø51mm and 4 well IVF dishes Suitable for Falcon Ø50mm, 4 well IVF dishes

Nunc dish insert Falcon dish insert Vitrolife dish insert

Vitrolife 4 well dishes Software

To monitor, record and display key performance

5

Data logger, including alarm functions

Fuses Supply fuses (220-240V)

2 x F 1.6AH (250V)

Supply fuses (100-120V)

2 x F 3.15AH (250V) Degree of protection

Type of protection against electric shock

Class I

Degree of protection against the ingress of water

IP30

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G185 SensorTech

Section 6 - G185 SensorTech G185 supports external and independent monitoring of the most critical parameters regarding CO2 concentration, temperature and pH measurement.

CAUTION: Installations of external sensors must be performed by CooperSurgical or by persons authorized by CooperSurgical only

External pH Monitoring This G185 SensorTech has been designed to work with Octax pH online. These parts are available from MTG GmbH. A fiber optic cable is built into chamber 1. A special Dish Insert must be used in the chamber where the pH optical fiber sensor is installed. There are three different Dish Inserts available depending on the dishes used:

6

•

Dish Insert Nunc pH Online Sensor:

Order code: 23060-1

•

Dish Insert Falcon pH Online Sensor:

Order code: 23061-1

•

Dish Insert Vitrolife pH Online Sensor:

Order code: 23079

Fiber Optic Cable in chamber 1

Special dish insert hole for Optical Fiber Sensor

The fiber optic cable is attached to a cover plate on the rear panel. When this cover plate is removed the fiber optic cable will follow out. An O-ring in the rear panel protects the cable from scratching against metal. A stopper is mounted on the cable inside to prevent the cable from being pulled out too far, thereby breaking the fiber.

Outlet of Fiber Optic Cable in rear panel

15

G185 SensorTech External Temperature and CO2 Monitoring The CO2 sensor recommended is a widely used sensor from Vaisala (GMP 251). It is a 0-10% high precision IR CO2 sensor. Vaisala offers several devices to support this sensor; both standalone and built-in modules. The sensor is placed in the rear part of the filter holder. It measures the gas circulating in the incubator. The opening is closed by use of a plug as standard.

Port for external CO2 Sensor

G185 SensorTech has a hidden hole for a pin-type temperature sensor.

6

The opening is in the aluminum block on the left side, between chambers 1 and 2. It is designed for a 3mm diameter sensor. A suitable sensor is available as part number 22306, which is compatible with the K-Systems F100 thermometer The sensor can be used to detect temperature changes in the G185. This sensor works as an addition to the sensors inside the G185 and should not be used for calibration purposes. Hole for external temperature sensor (Pin Type)

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