G95 Portable Incubator User Manual Oct 2020

CooperSurgical, Inc.

Contents

CONTENTS SECTION 1 – PREFACE

1

Copyright1

SECTION 2 - SAFETY WARNINGS

2

Glossary of Safety/Information Symbols

2

SECTION 3 - PRODUCT OVERVIEW

3

Unpacking and Inspection

3

Accessories3 Gas connector

3

Silicone tube

3

Optional Equipment

4

Warming blocks for tubes

4

Warming blocks for dishes

4

Supplementary equipment

5

Intended Use

5

General Description

5

Unit Performance

6

Connections6 General Care

6

SECTION 4 - BASIC OPERATION

7

Features and Operation

7

Assembling the G95

7

Connection to the Mains

7

Start of Apparatus

7

Operating the Heated Compartment

7

Keyboard Functions

7

Temperature Setting and Control

8

Combination Keys

8

Temperature Alarm

9

Warming Up 

9

Warming Blocks

9

Contents

CooperSurgical, Inc.

CONTENTS SECTION 5 - MENU FUNCTION

10

Overview of Options

11

Unit12 RS23212 Tune13 INT.T14 TI.St14 St.St15 Heat16 A-ST17 Hour18 Rest19

SECTION 6 - BATTERY FUNCTIONS

20

Charging the Battery

20

Battery Indications

20

SECTION 7 - THE USE OF TUBES OR DISHES

21

Loading with Tubes

21

Loading with Dishes

22

SECTION 8 - GASSING OF CO² INCUBATORS

23

Why Gassing? 

23

Gas Supply

23

Gas Pressure

23

Humidifying the Gas Mixture

23

Gas Flow Rate

23

Purging24

SECTION 9 - CARE AND MAINTENANCE

25

Cleaning25 Preparation at the Point of Use

25

Periodic Cleaning

25

Disinfection 

25

CooperSurgical, Inc.

Contents

CONTENTS Drying25 Calibration25 Disposal of electrical and electronic equipment. 

26

SECTION 10 - TROUBLESHOOTING

27

SECTION 11 - TECHNICAL DATA

28

SECTION 12 - SPARE PARTS

29

List of Spare Parts

29

Spare Parts - Explorer Viewer

30

SECTION 13 - WARRANTY INFORMATION AND LIMITS ON LIABILITY

31

SECTION 14 - RETURNING PRODUCT

32

Returned Goods Policy

32

Customer Service Contact Details:

33

US Only Customers Contact Details:

33

SECTION 15 - CUSTOMER SERVICE CONTACT INFORMATION

34

European Service Representatives

34

US Service Representatives

34

Section 1 Preface

CooperSurgical, Inc.

SECTION 1 – PREFACE

1

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: +1 (203)601-9818 International Phone: +45 46 79 02 02 [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.

1

Section 2

CooperSurgical, Inc.

Safety Warnings

SECTION 2 - SAFETY WARNINGS Glossary of Safety/Information Symbols Source: ISO 15223-1 and ISO 60601-1

Symbol

2 Meaning

In accordance with Low Voltage Directive 2014-35-EU CooperSurgical.com

0120

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

REF

Catalogue or Part number

SN

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

3

Stacking limited to 3 units

Keep dry

2

Section 3

Product Overview

CooperSurgical, Inc.

SECTION 3 - PRODUCT OVERVIEW Unpacking and Inspection • • • • • •

3

Unpack the equipment. Check the packing list to insure all accessories are there. Examine the packing material carefully for separately packed items. Check the incubator for external surface damage. Check that the display is not broken or damaged. Check that the lid and locking mechanism operate correctly without any hindrance.

Accessories Standard Accessories 24 volts main adapter (PSU) Order code: K51122 Mains Cable Standard Schuko UK US

Order code: 52768 Order code: 53886 Order code: 52773

Connection cable for 12 volt car cigarette lighter socket. Order code: 51016

Two plastic blocks for holding the warming blocks in place. Plastic insulation White Black

Gas connector Order code: 52156 Order code: 52192 Silicone tube Order code: 11066

3

Order code: 50004 Order code: 52772

Section 3

CooperSurgical, Inc.

Product Overview

Optional Equipment Optional equipment consists of a range of warming blocks, flowmeters and gas humidifiers. CooperSurgical recommend that the GHO1 is used for supplying gas to the portable incubator (See the section on Supplementary equipment)

Warming blocks for tubes

3

Warming block B06 Holds twelve tubes of Ø12mm Falcon 352003 Order code: 26006

Warming block B08 Holds ten tubes of Ø17 mm Falcon 352001 Order code: 26008

Warming blocks for dishes Warming block B16 Holds two culture dishes B16-Falcon 353001 Order code: 26059

Warming block B24 Holds one centre well dish Falcon 353653 Order code: 260027

B16N-NUNC 150318 Order code: 26060 Warming block B25 Holds one 60mm culture dish Falcon 353002 NUNC 150288 Order code: 26028

Warming block B26 Holds one 4-well Falcon dish with lid Falcon 353654 Order code: 26031

Warming block B28 Holds on 4-well dish NUNC 176740 Order code: 26029

Warming block B29 Holds on 5-well dish MiniTüb 19021/0005 Order code: 26030

4

Section 3

Product Overview

CooperSurgical, Inc.

Supplementary equipment The G95 is designed as a transport device, and not as a block warmer. It can be used in conjunction with the following K-Systems products. GH01 Standalone gas warmer, humidifier and flow regulator.” Order code: 31059

3

G73 Dry Bath Incubator for heating samples in test tubes. Order code: 22065

Intended Use The K-SYSTEMS CooperSurgical G95 Portable incubator is designed to provide a short-term environment with controlled temperature at or near body temperature and gas levels (CO2, O2) for gametes and embryos during transit for assisted reproductive technology (ART) treatments. The warming blocks should be pre-warmed to the desired temperature and allowed to stabilize before placing inside the G95 transport incubator. The temperature indication on the display is that of the maintaining temperature. If cool blocks are placed within the incubator, sufficient time is required for the temperature to stabilize. When the unit is not in use it is recommended that it is left on charge.

General Description The compartment and aluminium warming blocks maintain a preset temperature in the range of ambient to 49.9°C. The temperature is electronically controlled and can be read on the display in increaments of 0.1°C resolution. An alarm system provides both visual and audible alarm, if the temperature should be out of range or in case of low battery (when the mains adapter is not connected). A built-in battery maintains the temperature for 4 to 5 hours depending on ambient temperature. The battery will be charged when the incubator is connected to the mains adapter. Caution: additional heat can be generated whilst charging the battery. Do not place samples in the incubator whilst connected to the mains adapter. The incubator can be connected to a 12V car cigarette lighter socket during transport and whilst incubating samples. This provides power to maintain the temperature but does not charge the battery. The atmosphere is controlled by flushing with a gas mixture. The gas valve is automatically closed when the quick connector is disconnected. Interchangeable aluminium warming blocks, holding a variety of culture dishes and test tubes, are available. The blocks are held in position during transport by a removable plastic block.

5

Section 3

CooperSurgical, Inc.

Product Overview

Blanking Car socket / GH01 plug

Unit Performance

PSU RS 232 socket connector No longer supported

3

Gas inlet

The unit is connected and allowed to stabilise to the set point. Culture dishes and/or test tubes are placed in the interchangeable warming blocks which are held in secure positions during transport. The chamber is purged with the desired gas mixture (regulated for example by the GH01). During purging, the door is closed, but only sealed after purging. (See page 24) The gas supply is disconnected from the (quick release) valve at the back of the unit.

Connections Should the transport time exceed the 4 to 5-hour battery time the unit can be connected to the 12V cigarette lighter socket found in most automobiles. When not in use the unit should be connected to the mains power supply but should not be used for incubating samples. The unit can only be heated up from ambient using the mains adapter. The battery is designed only to maintain the temperature once warmed up. The car adaptor can only be used to extend the transport time. It will not charge the battery.

General Care Do not obstruct or block the ventilation holes at the back of the unit. Excessive force or pressure should not be put on the front door when it is fully opened. Ensure that the door hinges are clean and free of any obstructions. When closing the door, ensure that there are no objects preventing it from closing, as too much force will damage the closing catch, thereby degrading its performance.

Warning: This incubator is designed to transport pre-warmed blocks and does not have the capability of warming the blocks in a short period of time

6

Section 4

Basic Operation

CooperSurgical, Inc.

SECTION 4 - BASIC OPERATION Features and Operation Assembling the G95 No assembly needed. Just follow the directions below and the unit is ready for use.

Connection to the Mains The mains voltage is automatically regulated to the correct level by the main adapter (PSU). Connect the G95 to the mains supply using the enclosed PSU.

4

Start of Apparatus Connect the unit to the PSU and the PSU to the mains wall socket. To power up the unit, press the Heat ON/Off button on the keyboard. The display will indicate the current temperature.

8888 Alarm

Heat ON/OFF

LED Display

Set-point

Arrow keys UP/DOWN

Operating the Heated Compartment Keyboard Functions Action Press heat ON/OFF key to show the actual temperature.

7

Key

Display

36.0

Section 4

CooperSurgical, Inc.

Basic Operation

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.

4

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 alarm and set point key to go into power save mode.

+

Switches off the display.

Note: Powersave mode: Now only a small LED will light, showing when the heat is active. All other functions are kept normal. By switching off the display the energy is conserved and the battery charge holding time prolonged.

8

Section 4

Basic Operation

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.

4

Note: The red LED light and the acoustic signal will turn off when the temperature stabilizes to the set-point level

Warming Up Warming up from 20.0 to 39.0°C takes less than 15 minutes under normal conditions. When a cold item is placed in the chamber it may need up to 30 minutes to stabilize, depending on the thermal mass of the object and the initial temperature. It is recommended to pre-warm warming blocks before they are placed in the incubator. Always let the unit stabilize before use. Caution: Check the temperature at the base of the incubator chamber with a calibrated thermometer before placing the samples inside.

Warming Blocks It is necessary to use warming blocks. Please contact your local distributor or K-SYSTEMS for details about the full range of warming blocks. A selection of different tubes and dishes can be transported. Either tubes or dishes can be transported at one time, not a combination of both. Warning: Warming blocks should always be pre-heated before usage.

9

Section 5

CooperSurgical, Inc.

Menu Function

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.

5

Press and hold UP+DOWN key for 3 seconds again to exit the menu.

The menu consists of the 10 options listed below. For further detail see the description on the following pages.

10

Section 5 Menu Function

CooperSurgical, Inc.

Overview of Options UNIT

˚C ˚F

RS232

Send S-2 S-1

On

}

Off

TUNE

+0.05 -0.05 Calib. value

5 INT.T

+0.1 -0.1

Ti.St

M+1 H+1

St.St

M+1 H+1

HEAT

On Off

A-St

On Off

HOUR

On Off

REST

---Software version

11

Version 3

Section 5

CooperSurgical, Inc.

Menu Function

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.

5

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.

RS232 The RS232 port is only for service purposes.

12

Section 5 Menu Function

CooperSurgical, Inc.

Tune The TUNE option is for calibration of the displayed temperature. If there is an offset 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 control conducted on this basis. Follow these steps to navigate in the TUNE 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.

5

tunE

Press DOWN key until the option “TUNE” 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 temperature. 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.

To see the calibration value Action

Key

Display

Press and hold set point key. While holding the set point key in, press the HEAT Key.

+

The calibration value is shown

Caution: Any change in the factory set calibration should always be based on very accurate temperature measurements. CooperSurgical only recommends the use of a high quality PT-100 sensor that is calibrated with the precision instrument used for measuring according to the manufacturers specifications. Also ensure an optimal contact between the sensor and the place measured. Use only a sensor type that is correct for the purpose and of correct size. If in doubt contact your local CooperSurgical distributor.

13

Section 5

CooperSurgical, Inc.

Menu Function

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 different level the controlling principle will be affected. From the factory it is set to a closely calculated value specific for the model. In version 3, this value is locked and can’t be changed. Caution: Do not change the value here. If by mistake any changes are made or doubts occur if the value are correct please see the REST function in the menu for the restore of the defaults

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

5

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. 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.

14

Section 5 Menu Function

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 G95 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.

5

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, (see page 16) 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 affected in way. Caution should always be exercised when a heated area is turned on without any supervision.

15

Section 5

CooperSurgical, Inc.

Menu Function

Heat The HEAT option is used for the heater to turn on at a present 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 option “UNIT” will appear in the display. Press DOWN key once until the option “HEAT” appears in the display.

hEAt 5

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.

16