L234 IVF CellTouch Class II Workstation Instruction Manual Rev A May 2018

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

CONTENT 1. GENERAL INFORMATION AND SERVICE... 4 1.2 Operating Principles... 4 1.3 Copyright... 5 1.4 Customer Service Contact Information... 5 2. GENERAL INFORMATION AND SERVICE ... 6 2.1 Pre-Operational Notes... 6 2.2 Requirements of the Operator/Intended User Profile... 6 2.3 Operating Environment... 6 2.4 Applicability of the Instructions... 6 2.5 Warranty... 6 3. INTRODUCTION ... 7 3.1 Safety Symbols on the Unit... 7 3.2 General Safety... 8 4. SETUP... 9 4.1 Environment... 9 4.2 Electromagnetic and Other Interferences... 9 4.3 Safety Level... 10 5. FEATURES... 11 5.1 Main Components...11 5.2 Inside the Unit... 12 5.3 Connections Panel... 13 5.4 Airflow and Filter... 14 5.5 Touch Screen... 14 5.6 Microscope Light... 14 5.7 AluHeat Technology... 14 5.8 Tray Hatch... 14 5.9 Lock... 14 5.10 Network Connection... 14 5.11 Gas System Connector... 14 5.12 Alarm Output... 14 5.13 Backside of the Unit... 15 6. USER SETUP... 16 6.1 Login... 16 6.2 Change Password... 16 6.3 Create New User... 17 6.4 Delete User... 19 6.5 Log... 19 6.6 Logging Out... 19 6.7 Lost Password... 19 6.8 Access Levels... 20 7. FUNCTIONS AND SETTINGS... 21 7.1 Set Time and Date... 22 7.2 Ethernet Configuration... 23 7.3 K-Link... 24 7.4 Unit Lock... 29 8. TEMPERATURE SETPOINT... 30 8.1 Temperature... 30 8.2 Logs... 30 8.3 Timer Schedule... 31 8.4 Alarm... 32 2

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

CONTENT CONT. 9. MICROSCOPE LIGHT... 33 9.1 Microscope Light Unit... 34 9.2 Filters... 34 9.3 Light Source (LS112/114 LED)... 35 10. SERVICE INFORMATION... 39 10.1 Service Tab... 39 10.2 Fuses... 39 11. OPERATION... 40 11.1 Clean the Unit... 40 11.2 General Workflow Overview... 41 11.3 Fans... 41 11.4 Monitor... 41 12. MAINTENANCE... 47 12.1 Daily Maintenance... 47 12.2 Weekly Maintenance... 47 12.3 Annual Maintenance... 47 12.4 Replacing Interior Light... 48 13. TROUBLESHOOTING... 49 14. DISPOSABLE AND RECYCLING... 51 15. TECHNICAL DATA... 53 16. EXPLANATION OF SYMBOLS... 56 17. WARRANTY INFORMATION ON LIABILITY... 57

3

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

1. GENERAL INFORMATION & SERVICE 1.1 Intended Use Intended Use The intended use of the L234 IVF CellTouch is to establish a single workplace with a laminar flow hood for manipulations of embryos and blastocysts. Significant performance characteristics The K-SYSTEMS® L234 IVF CellTouch is a device for maintaining temperature and clean air conditions for gametes and/or embryos. The workstation is designed as a biological safety cabinet to protect both the embryos and the operator.

1.2 Operating Principles The idea is to achieve the best possible environment for gametes and embryos during the various procedures. A single aseptic workplace created by the controllable laminar flow (with two HEPA filters) and a recirculation of air flow through HEPA filters (app. 70% recirculation – app. 30% exhaust). The average air speed inside the work area is approximately 0.30 m/s and the velocity is measured via an anemometer placed inside the work area. Any deviation from safe conditions will be indicated visually and acoustically. The HEPA filters are H14 grade filters having an efficiency of 99.995% regarding particles size < 0.3μm. Incorporating a heated area together with the option of having humidified premixed gas helps in keeping correct pH-levels, required in various ART techniques. The gas used for these workstations is a suitable premixed gas. The workstations are prepared for the mounting of a stereo microscope, on the right hand side or on the left hand side. The workstation will be operated from a touchscreen, and is available with an integrated monitor as an option.

4

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

1.3 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 products should not hesitate to contact us if there are any unclear points or ambiguities in this manual.

1.4 Customer Service Contact Information U.S. Service Representatives CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA Customer Service: Phone: (800) 243-2974 Fax: (800) 262-0105 International Phone: +1 (203) 601-9818 Fax: +1 (203) 601-4747 Service Related Emails: [email protected] www.coopersurgical.com

European Service Representatives ORIGIO a/s Knardrupvej 2 2760 Måløv Denmark Customer Service: +45 46 79 02 02 Fax: +45 46 79 03 02 Email: New Purchases: [email protected] Service Related Emails: [email protected] www.origio.com

5

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

2. GENERAL INFORMATION & SERVICE 2.1 Pre-Operational Notes • • • • • • • • •

The unit is connected, the gas is attached and the unit is turned on - after 30 minutes the unit will be at a constant working temperature and air flow. An antiseptic work environment has been reached. Put on required personal protective gear, e.g. hand, face, or body protection. Place samples only within the defined work area of the workplate. Do not place unnecessary items in the sample chamber. Use only disinfected and cleaned accessories for the work process. Do not cause air turbulence, by quick hand, arm or body movement in the sample chamber or in front of the work opening. Do not place accessories into the sample chamber that cause air turbulence or emit excessive heat. Do not block air circulation at the ventilation slots of the workplate. Clean and disinfect sample chamber surfaces at regular intervals.

2.2 Requirements of the Operator/Intended User Profile The L234 IVF CellTouch shall be used by skilled personnel trained in use of biological safety cabinet IVF workstations (Class II LAF benches). The user profile is trained health professional, who as a qualified person perform the functions of fertilizing the human egg.

2.3 Operating Environment The L234 IVF CellTouch is intended to be used at room temperature (20-30°C), in a clean room at medical clinics and hospital laboratories under steady conditions.

2.4 Applicability of the Instructions • • •

Keep the instructions close to the device, this way you ensure having easy access to the safety instructions and important information. Please note that the contents of this manual are subject to change without further notice. If you encounter problems that are not mentioned in this manual in detail, please contact your local Customer Service Representative for more information.

2.5 Warranty CooperSurgical, Inc. warrants the operational safety and correct system operation of the whole unit under the condition that: • The device is operated as described in the manuals • The device has not been modified • All service intervals are kept according to the manuals • Only original spare parts and accessories that have been approved by CooperSurgical, Inc. are used

6

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

3. INTRODUCTION 3.1 Safety Symbols on the Unit Warning: This equipment must be protectively earthed

Consult instructions for use

BEWARE this unit contains static sensitive devices

ESD warning

Biohazard

Specific warning or precaution

7

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

Fuse Labels Aux, light T5.0AH, 250V

Fans T4.0AH 250V

Right table T10.0AH, 250V

Controller T10.0AH, 250V Left table T10.0AH, 250V

AUX, monitor T1.0AH, 250V

Outlets T1.0AH, 250V

Product Model Label

L234 IVF CellTouch 3.2 General Safety

! •

Use only suitable premix gas. Use of other gasses could result in serious injury, depending on the gas connected.

! • • • • • • • • • • • • •

WARNING

CAUTION

Make sure that the device is correctly earthed using grounding-type plug. Never place other heat generating equipment under the tabletop. Never attempt to block any of the air flow holes on the tabletop and on top of the unit. Make sure that all devices emitting electromagnetic radiation are kept at a reasonable distance from the L234 IVF Workstation to avoid any potential electromagnetic or other interferences. Make sure there are separate power circuits that are intended for use with medical equipment only. Never try to move the unit without consulting CooperSurgical or a person authorized by CooperSurgical. Read and understand the manual completely before use. Do not use the workstation if the outer packaging is damaged. Never use and handle this unit in other ways than specified in this manual, your safety may be at risk and the unit may be damaged. Do not perform repairs, disassembles, assembly operations, extensions, re-adjustments or modifications on this unit. This must be carried out only by CooperSurgical or by persons authorized by CooperSurgical. Do not work in the workspace area when the fans are switched off. Never use the device without the front windows correctly attached. Always wear full protective equipment and clothing (i.e. gloves, masks and general clean room clothing).

8

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

• • • • • • • • •

Always have the hatch closed when using the unit. Never use the workstation without original K-SYSTEMS HEPA filters. Do not expose filters to liquids. Change filters that have been exposed to liquids. Never try to lift or move the unit alone. Always wear protective shoes while moving the unit. Protect the power cord. Always use a grounding-type plug. If the plug does not fit into your outlet, consult an electrician for replacement of the outlet. Unplug the unit during lightning storms or when unused for a long period of time. Reduce the risk of fire or electric shock. This equipment should not be exposed to rain or moisture and large objects filled with liquids (>500ml).

NOTICE •

Do not change the calibration value yourself. This should be done only by an authorized CooperSurgical service technician, as described in the service manual.

•

Do not use the workstation at room temperatures exceeding 30 °C. The relative humidity must not exceed 75% (non-condensing).

4. SETUP 4.1 Environment Temperature

20 – 30 oC

Humidity

Less than 75% (non-condensing)

Placement

On a flat, hard and stable surface. Unit must be kept away from heating and cooling devices.

Clearance

Allow at least 2 cm clearance from the rear, 30 cm from the top and 20 cm from left and right for proper ventilation.

Environment

Indoor use only. Avoid high temperature, moisture, water and dust. This unit must not be exposed to dripping or splashing. This unit is designed for use at altitudes under 2000 m.

4.2 Electromagnetic and Other Interferences All electronic devices, especially electronic equipment containing radio senders and/or receivers, such as mobile phones, computers, and antennas, give off electromagnetic emissions. This is radiation that is a byproduct of electrical or magnetic activity. The emissions from such devices can interfere with other devices, causing potential problems. Equipment can be affected by electromagnetic interferences from other devices in two major ways: one is direct effect through proximity with other devices, and the other is electrical interference from power lines. Therefore, it is strongly recommended to: • •

Make sure all devices emitting electromagnetic radiation are kept a reasonable distance from the L234 Workstation to avoid any potential electromagnetic or other interference; Have separate power circuits that are intended for use for medical equipment only.

9

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

4.3 Safety Level The L234 Workstation has two safety levels: Standard: •

It is possible to operate all features in the workstation individually.

High (High Safety Level is optional and only available in selected countries): • • • • • •

The fan will always be at Full speed when turned on. Settings/features can only be operated when the fan is turned on. Lights and microsope lights cannot be operated unless the fan is turn on. In the time menu the fan timer changes so that it can only be set to: ON/OFF. All preprogramed Fan settings in Timer menu will be changed to full speed. Two flow-sensors are placed in the L234, one to monitor the downflow in work area and one to monitor the exhaust flow. Flow alarm will sound if any of the sensors detect flow disturbance.

10

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

5. FEATURES 5.1 Main Components

① ② ③ ④ ⑤ ⑥ ⑦

COMPONENT 1 Airflow outlet 2 Touch screen /Android unit 3 Monitor (optional) 4 Heat zones 5 Airflow inlet 6 Microscope light 7 Hatch

11

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

5.2 Inside the Unit External computing devices connected to the Ethernet and HDMI connector of IVF workstation must only be Limited Power Source and SELV circuit according to the standards IEC/UL 60950-1.

HDMI

①

②

④

③

⑤

COMPONENT 1 Monitor (optional) 2

Power outlet 230 VAC / 115 VAC

3

Gas hose connector

4

Power outlet for video camera

5

HDMI connector for monitor

The unit may have an optional extra power outlet.

Max 100W

Max 100W

Max load is 100W per power outlet. 12

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

5.3 Connections Panel External computing devices connected to the Ethernet and HDMI connector of workstation must only be Limited Power Source and SELV circuit according to the standards IEC/UL 60950-1.

④

① WARNING USE ONLY SUITABLE PREMIX GAS

② ③

⑤ ⑥

WARNING THIS EQUIPMENT MUST BE PROTECTIVELY EARTHED

COMPONENT 1

Lock

2

Mains connection with fuse

3

Network connection

4

Main switch ON/OFF

5

Gas system connector

6

Alarm output (normally closed)

13

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

5.4 Airflow and Filter The airflow keeps particles away from the operator. The air is filtrated through the HEPA filters to ensure it is clean when leaving and circulating through the unit (See Section 1: General Information and Service).

5.5 Touch Screen With the exception of the microscope light, all functions and adjustments are accessed via the touch screen.

5.6 Microscope Light The microscope light is adjustable (See Section 9.3: Light Source (LS112/LS114 LED).

5.7 AluHeat Technology The units are equipped with adjustable heat zones. The heat zones are marked on the tabletop (See Section 8: Temperature Set Point).

5.8 Tray Hatch The hatch allows access to the tray (See Section 12: Maintenance).

5.9 Lock The unit has a lock with a set of keys. It is only possible to switch the unit on/off when it is unlocked and the key is in place (See Section 7.4: Unit Lock).

5.10 Network Connection RJ45 network connector for optional data logger (See Section 7.3: Data Logger PC Version Set-up).

5.11 Gas System Connector Gas hose connector for optional premix gas system GH01. (See the Gas Equipment User Manual).

5.12 Alarm Output Output for external alarm system (e.g. sms alarm system). For more information, contact an authorized Customer Service Representative.

14

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

5.13 Backside of Unit

① ②

⑤ BEWARE this unit contains static sensitive devices

BEWARE this unit contains static sensitive devices

⑥ ③ ⑦ ④ FEATURE 1

ESD label

2

Left table, controller and auxiliary fuses

3

Fan fuse

4

Right table and outlets fuses

5

Light and AUX fuses

6

Warning labels (Shock hazard)

7

Technique hatches

15

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

6. USER SETUP 1

6.1 Login 6.1.1 Press the Settings tab 1 . 6.1.2 Press Settings 2 under Security.

2

6.1.3 The user “admin” (Factory setting) is the only active user upon delivery of the workstation. The admin’s password is 1234. The user “admin” cannot be deleted. However, the password is editable and should be changed. (See Change Password: Section 6.2)

1

Press the “admin” user name 1 and press Login 2 , or press Exit 3 to return to the previous menu.

2

3

5

4

6.1.4 Enter the password. The default password is 1234. Press OK 4 to proceed, Cancel 5 to abort or Back 6 to return to the previous menu.

6

6.2 Change Password 6.2.1 Press Change password 1 .

1 16

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

2 6.2.2 Enter the current password 2 . Enter the new password twice 3 . The password must be between 4 and 10 digits long. Press OK 4 or Cancel 5 to abort.

3 5

4

If you don’t enter the same password twice, this warning appears.

6.3 Create New User

1

6.3.1 In the main window, Press New 1 .

6.3.2 Select Advanced or Super user level 2 .

2 6.3.3 When you press the buttons for the user’s name 3 , a keyboard pops up.

Enter Surname, First name and User name. Press Next.

17

3

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

6.3.4 When pressing the buttons for the password 4 , the numeric keyboard pops up. Enter a password between 4 and 10 digits. Press OK 5 .

4

5

6.3.5 Select a user in the main window, and press Edit 1 .

1

6.3.6 The security level, names and password can be edited here. Press Save 2 when done.

2

18

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

6.4 Delete User

6.4.1 Select a user in the main window, and press Delete 1 .

1 6.4.2 Press OK 2 to delete the user or Cancel 3 to return to the previous menu. It is not possible to delete the “admin” user.

2

6.5 Log

3

6.5.1 In the main window press Log 1 .

1

The log shows the last 100 changes including their date, time and user. You can slide the screen up and down.

6.6 Logging Out 6.6.1 In the main window press Logout 1 . Super users will be automatically logged out after 5 minutes without activity.

6.7 Lost Password If all super user passwords become lost, please contact your local K-SYSTEM distributor to acquire a special login that is calculated from the unit’s serial number.

1

19

INSTRUCTION MANUAL FOR L234 IVF CELLTOUCH CLASS II WORKSTATION

6.8 Access Levels To prevent unauthorized changes to setup parameters, the unit provides different access levels. The unit supports 3 access levels: User, Advanced user and Super user. The access levels are described below: USER (NO LOGIN REQUIRED) • Switch heat and light ON/OFF • Switch fan ON/OFF/reduced • Move between the different tabs • See the alarm log • See the security log and users

ADVANCED USER (LOGIN REQUIRED)

SUPER USER (LOGIN REQUIRED)

Same as User and

Same as Advanced user and • Safety Level* • Calibration • Create new users • Edit users • Delete users

• Change setpoint • Change timers • Change settings • Change own password

*Only in Safety Setting High

1

6.8.1 When changing a parameter that requires authorization, the login window will pop up on the touch screen. If you leave the topic that requires login, you will automatically be logged out. The popup only shows users possessing a valid access level. Press your user name 1 and press OK 2 .

2

6.8.2 Enter your password and press OK 3 .

3 6.8.3 If you enter a wrong password, a message will be displayed. Press OK 4 and try again.

20

4