L100 Series Workstations Instruction Manual Oct 2022

INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.11

Setup Menu (StuP),

6.12

Info Menu (inFo),

30

6.11.1 6.11.2

Fan Speed (Fn.SP), 31 Calibrate Value Zone-1 (tn-1),

6.12.1 6.12.2

Version Number (vEr), Reset (rESt), 34

33

7

DIFFERENT HEATED SURFACES,

35

8

CONNECTIONS, 8.1

9

Connectors on the Back, 8.1.1 8.1.2 8.1.3

40

10.1 10.2

General Description, 40 Operating Instructions, 41

10.3

Maintenance,

10.4 10.5 10.6

Accessories, 42 Troubleshooting, 42 Technical Data, 42

10.2.1 10.2.2 10.2.3 10.2.4 10.2.5

“ON” Function, 41 To Increase the Light Intensity, 41 To Decrease the Light Intensity, 41 “OFF” Function, 41 Adjusting the Mirror, 41

10.3.1 10.3.2

Cleaning, 42 Replacement of LED Lamp House,

42

TROUBLESHOOTING,

12

MAINTENANCE,

12.2

12.1.1 12.1.2

45 45

12.1.3 12.1.4

Daily Maintenance, 45 Monthly Maintenance, 45 12.1.2.1 Rinsing of Humidification System Procedure:, Three Month Maintenance, 47 Annual Maintenance, 47

12.2.1 12.2.2

Replacing the Pre-filter, 47 Replacing the Interior Light, 48

Specific Service Operations,

47

49

Description,

49

14

DISPOSAL PROCEDURE,

15

TECHNICAL SPECIFICATIONS,

16

ACCESSORIES, 16.1 16.2 16.3

42

43

Routine Maintenance,

MONITOR, 13.1

17

38

Establish the Flow Rate, 38 Humidifying the Gas Mixture, 39 Purging, 39 Operating the Microscope Light, 40

11

13

36

Circuit Fuses, 36 Mains Connection, 36 Gas Connections, 37

LIGHT SOURCE (LS112 LED),

12.1

32

36

GASSING STATION OPERATION, 9.1 9.2 9.3 9.4

10

32

51 52

54

Warming Blocks, 54 Mixed Gas Supply, 54 Gas Washing Bottles, 54

WARRANTY INFORMATION AND LIMITS ON LIABILITY, 17.1

Returned Goods Policy,

56

18

CUSTOMER SERVICE CONTACT INFORMATION,

19

EXPLANATION OF SYMBOLS,

57 3

57

55

46

INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

1

GENERAL INFORMATION & SERVICE 1.1

General Description

The K-SYSTEMS ® IVF L100 Series is a complete workstation for human and animal reproduction. It has a warmed stainless steel table plate and the table plate maintains a temperature in the range 35-43°C. The L124/L126 is heated by means of an electronically controlled heating system. The vertical laminar airflow passes through a HEPA main filter and protects the cell culture against airborne particulate contamination.

1.2

Intended Purpose

To reduce Volatile Organic Compounds (VOCs), Chemical Air Contaminants (CACs) and other particulate contaminates from air circulating in a laminar flow hood where Assisted Reproductive Technology (ART) procedures are conducted”.

1.3

Operating Principles and Features

The workstation provides a confined workspace in which the stable vertical unidirectional flow (laminar flow) protects the product that is being handled against particulate contamination from the surroundings and the operator. All operations take place through the front opening. Pressure in the work chamber keeps the clean air flowing from the work chamber to the surroundings, avoiding the introduction of particulate contamination to the work chamber.

1.4

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.

1.5

Customer Service Contact Information

European Service Representatives

U.S. Service Representatives

ORIGIO a/s Knardrupvej 2 2760 Måløv Denmark

CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA Customer Service: Phone: (800) 243-2974 Fax: (800) 262-0105

Customer Service: Tel: +45 46 79 02 02 Fax: +45 46 79 03 02 New Purchases: [email protected]

International Phone: +1 (203) 601-9810 Fax: +1 (203) 601-4747

Service Related E-mail: [email protected]

Service Related E-mail: [email protected]

www.fertility.coopersurgical.com

www.coopersurgical.com

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

CAUTION

2

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.

GENERAL OPERATIONAL INSTRUCTIONS 2.1

Pre-Operational Notes •



 • • • • •

• • •

2.2

The workstation fan must be run at normal speed for at least 15 minutes prior to working inside the workstation.  A green control light indicates proper operation. The work chamber is to be carefully cleaned and/or disinfected (See Section 14: Maintenance). For reliable operation it is important that the air-flow conditions are as undisturbed as possible. Therefore, never overload the work chamber - insert only those utensils necessary for the actual work. Objects and utensils must be carefully cleaned and/or disinfected before bringing them into the work chamber. Necessary utensils for use during work must be placed within reach to avoid unnecessary movement inside the workstation. Put on necessary personal clothing for reducing particle emission from operator (i.e. gloves, masks and general clean room clothing). Special attention should be given to hands and lower parts of the arms, as these are the parts of the operator most likely to emit particles near the product. All work in the workstation must be performed with tranquil movements. Rapid arm movements in the chamber may cause slipstreams, which will draw contaminated air into the work chamber. The number of transports into the work chamber must be minimized. Transport of possibly contaminated material may create airflows that can contaminate the product.

Moving the Unit

The L100 is designed as a stationary unit and it should not be moved once it has been installed. If the workstation must be moved,contact your authorised service representative.

2.3

Instruction of the Operating Personnel

These operating instructions describe the L100 Workstation series covering the following models: • • • • •

L124 IVF Workstation, L126 IVF Workstation, L126 DUAL IVF Workstation, L126 MP Workstation L124 ICSI Workstation.

The L100 IVF Workstations have been manufactured in keeping with the latest technologies and developments. It has been tested during assembly and before delivery to ensure correct operation. However, it may present potential hazards to user, if this unit is used in conditions that lies outside of its intentional way of use.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

It is strongly recommended that: •

Only trained and authorized personnel perform any operation on the cabinet.

•

Only trained and authorized service personnel perform any repairs to the device.

CAUTION

2.4

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.

Applicability of the Instructions • • •

Keep these 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 detailed, please contact your local Customer Service Representative for more information.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

3

INTRODUCTION 3.1

Safety Symbols Used on the Unit

The L100 Workstation contains high voltage components that may be hazardous. It is strongly recommended not to remove the back cover. This equipment doesn’t contain any user serviceable parts inside. It is recommended to have qualified service personnel perform any service needed on the equipment.

Fuse Label

DANGER

High Voltage Hazard Label

Isolate main supply before removing cover WARNING Mains Cable

Warning Label on Mains Wire (Schuko).

IVF Workstation L124

Product Model Label

WARNING VOID IF REMOVED

Warranty Label – Warning Ground Label

WARNING THIS EQUIPMENT MUST BE EARTHED

Earth Warning Warning for 110V Countries

115V

240V AC

Warning for 230/240V Countries Caution-Consult this manual for safety precautions

Microscope power outlet: Maximum 200W per outlet

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

3.2 • • • • • • • • • • • • •

3.3

Read and understand the user manual completely before use. Do not use product if package is damaged. Do not use device without the front windows correctly attached. Perform temperature calibration in the intervals described in the manuals. Do not use this product at temperatures exceeding 30°C. Always use HEPA filter for input gas to unit. Never use a non K-SYSTEMS filter. Use only premixed gas (eg. 5% CO2 in air). Make sure that the gas supply pressure is kept stable at 0.5-0.7 bar. The power cord is to be used for mains disconnection. Always connect power cord to a proper grounded outlet. To reduce the risk of fire or electric shock, this equipment should not be exposed to rain or moistures and objects filled with liquids. Always use fuses according to the manufacturer descriptions.

Important Safety Instructions • • • • • • • • • • • • • •

3.4

Precautions / Warnings

Read this safety instruction carefully before using equipment. Always keep these instructions. Heed all warnings. Follow all instructions. Refer all servicing to qualified service personnel. Do not use this apparatus near water. Do not block any ventilation openings. Do not install near any heat sources such as radiators, heat registers, stoves or other apparatus that produce heat. This apparatus must be connected to a grounded (3-pin) socket. If the provided plug does not fit into your outlet, consult and electrician for replacement of the outlet. Protect the power cord from being walked on or pinched, particularly at plugs, convenience receptacles, and the point where they exit from the unit. Only use attachments/accessories specified by the manufacturer. Use only with the cart and stand specified by the manufacturer or sold with the unit. Unplug the unit during lightning, storms or when unused for a long period of time. Servicing is required according to service manual or if the unit has been damaged in any way, such as if it has been dropped, exposed to rain or moisture, or does not operate normally.

Transport

To prevent tilting, always transport the device using a suitable carrier, even for a transport within a building, and separate it from the stand.

CAUTION

Do not transport the device over large distances without transport lock and original device packaging

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

The device is packed in a wooden crate mounted and strapped to a wooden pallet. The workstation is also fixed to the pallet with 2 screws in the back. For the safety of the device and making sure that the device has been properly handled, anti-shock and anti-tilt sensors are placed on the exterior of the crate. In case of activation of the sensors, notify and report it immediately to your transporter and your local CooperSurgical Representative. Inspect the device accordingly for damages.

Handling Indicator

Handling Indicator

NOTE: CooperSurgical is responsible for delivery and installation of the device at user facility.

4

GENERAL DESCRIPTION 4.1

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 radiation 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 interference from other devices in two major ways: The first is direct effects through proximity with other devices, and the second is electrical interference over the power lines. It is strongly recommended to: • •

5

Make sure that all devices emitting electromagnetic radiation are kept a reasonable distance away from the workstations in order to avoid any potential electromagnetic or other interferences. Have separate power circuits that are intended for use for medical equipment only.

FEATURES 5.1

Laminar Flow

The L124 and the L126 IVF Workstations are supplied with two laminar flow modes: •

The Normal Mode must be used when working inside or nearby the laminar flow hood.

•

The Standby Mode maintains the workstation interior under aseptic conditions, but working inside the workstation or near the workstation may cause changes in the airflow.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

5.1.1

Flow Pattern Diagram

5.1.2

Pre-filter

Air entering the workstation is pre-filtered with an efficiency of 83%.

WARNING

5.1.3

Only use original K-SYSTEMS VOC filters.

Fan

The air is drawn into the fan in the top of the workstation where it is pressurized. From the pressure plenum the air passes through the HEPA main filter.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

5.1.4

Main Filter

The filter efficiency of the HEPA main filter is 99.995% of particles 0.3 μm (D.O.P. test). The air flows from the main filter through the work chamber in a vertical unidirectional flow of clean air. Immediately before reaching the tabletop, the air separates and flows out through the back wall, and through the work opening. The air returns to the suction opening of the workstation passing through the surrounding space. 5.1.5

Gassing Station

Most of the culture media that is used in assisted reproduction techniques is sensitive to changes in pH, it is important to flush the media with CO2. The pH of the media in the test tubes and dishes may be controlled by flushing with appropriate gas mixtures.

The pre-mixed CO2 gas supply is connected to the back of the IVF Workstation. It is being heated and humidified by the gas washing bottles placed in the inner wall of the IVF workstation and coming out through the gassing nozzles built into the table plate. An incubator hood should be placed above the nozzles at all times. The flow rate can be adjusted as well as read at the display in the inner wall For optimal use, only distilled water should be used.

5.1.6

Gas Mixture

Follow indications from the culture media provider for correct handling of media. Culture media must be maintained at a pH of about 7.4, this can be obtained by gassing with an atmosphere of 5% CO2. The most frequently used gas mixtures are 5% CO2-in-air, and 5% CO2, 5% O2 and 90% N2.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

5.2

Stereo Microscope

A stereo microscope with light source is installed in the table plate. For the MP Version of the L100 Workstation, an inverted microscope can also be installed. Consult the Microscope Compatibility Guide (document QP-300-250) for microscope compatibility using the universal micorscope mount.

5.3

Interior Light

The interior light provides overhead illumination.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6

KEYBOARD FUNCTIONS

K-SYSTEMS Microscope Light Source Fan ON, Reduced Fan Speed, Fan OFF

Alarm, Disable/Enable Acoustic Alarm

Interior Light ON and OFF

Heated Surface ON and OFF

Set-Point Key

Adjust Set-Temperature

Keyboard Lock/Unlock

except

Hold both keys for 3 seconds to enter the menu or exit the menu Temperature Display: Change between left and right on the display (L126 Dual or fully Heated) Change between left and right camera (L126 Dual and L126 MP) Change between hour and temperature reading Heat area ON/OFF (only L126 Dual or Fully Heated)

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.1

The Interior Light

ACTION

KEY

Press the switch to turn the interior light ON, indicated by the yellow light. Press again and the interior light turns OFF.

6.1.1

Operating the Laminar Air Flow

ACTION

KEY

Activating the laminar flow. Press one time and the fan will run at full speed, indicated by the green light (normal model). A five digit number will run though the display showing the total hour count for the HEPA filter. Press once more and the fan will operate at reduced speed, indicated by the green light flashing (standby mode). Press one more time and the fan will switch OFF, and the time will be shown.

CAUTION

There will be an alarm when the fan has run for 17,000 hours, indicating that the HEPA filter must be checked. When the alarm goes on the fan can still be used. See page 47 Annual maintenance.

6.2

Heating System

6.2.1

Table Heating Unit

ACTION

KEY

except

Press one time and the HEAT will turn ON. The display shows the actual table temperature. Press again and the HEAT will be turned OFF. 6.2.2

Setting the Temperature

ACTION

KEY

Press the key with the symbol SP, the display will flash between the SET-POINT temperature and the unit that the temperature is shown in. Hold down the SP key and press the UP or DOWN key to change the SET-POINT temperature. When the SET-POINT is set, release both keys.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

NOTE:

If the SP key and the UP or DOWN keys are pressed continuously, the temperature setting will change quickly. To change the temperature slowly, press one step at a time.

The L126 Dual can have separate SET-POINTS for each heated surface. Press the DOWN key to change between right and left temperature readings. Right Temperature Reading: ACTION

KEY

Press the SP key, and the display will flash between "r °C" / " r °F" and the SET-POINT temperature. ("r °C" / " r °F" means the SET-POINT for the right side). Hold down the SP key and press the UP or DOWN key to change the setpoint temperature. When the SET-POINT is set, release both keys.

Left Temperature Reading: ACTION

KEY

Press the SP key, and the display will flash between "L °C" / " L °F" and the SET-POINT temperature. ("L °C" / " L °F" means the SET-POINT for the left side). Hold down the SP key and press the UP or DOWN keys to change the setpoint temperature. When the SET-POINT is set release both keys. NOTE: It is only possible to have two SET-POINTS if the SP function in the menu is set to "L-r".

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.2.3

Alarm

The workstations have an alarm that warns if the temperature is too high or too low. The system also has an error mode alarm. The alarm is a visual red light on the keyboard display with an audible pulsating alarm tone. The alarm will sound the first time the unit is powered up or after a power shortage. The alarm can be turned off by pushing the SP key. When the heating system is first activated, it will warm until the set-temperature has been reached. During this period the alarm will not be activated. The following messages can be shown on the display in case of alarm: DISPLAY

MESSAGE

Temperature alarm on Zone-1 (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-2 (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-3 (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-L (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-r (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-4 (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-5 (See Section 7: Different Heated Surfaces). Temperature alarm on Zone-6 (See Section 7: Different Heated Surfaces). Temperature alarm on the heat area (See Section 7: Different Heated Surfaces). Error mode: Reset the workstation by disconnecting the power (sound can’t be muted). NOTE: Warming up from 20°C to 37°C takes approximately 45 minutes without warming blocks on the table. After placing an aluminum block on the table, it may take up to 30 minutes for the block temperature to stabilize, depending on the initial block temperature.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.3

Alarm Key

ACTION

KEY

When the workstation has an alarm, press the ALARM key to mute the sound.

6.4

Keyboard Lock

ACTION

KEY

Press the SP key and the temperature ALARM key at the same time to lock the keyboard. When pressing a random key, except the microscope light, the display will show "lock", while the keyboard is locked. Note that the alarm can still be muted.

6.5

Keyboard Unlock

ACTION

KEY

Press the SP key and the ALARM key at the same time to unlock the keyboard.

6.6

Operating the Microscope Light

ACTION

KEY

The microscope light source can be turned on and adjusted when using K-SYSTEMS light source (LS112), by pressing either ▲ (increase intensity) or ▼(decrease intensity). The microscope light is switched off by simultaneously pressing both switches (▲ and ▼) and then releasing them. NOTE: Always turn off the light when it is not in use. This will increase the lifetime of the bulb.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.7

Menu Function

The workstations have a number of advanced functions that the user can access. The four main menus are listed in Section 6.8. ACTION

KEY

Enter the menu function by pressing and holding the UP and DOWN keys for 3 seconds. Press the UP or DOWN keys to navigate within the menu Press the SP key once to enter each main menu. Press and hold the SP key to change values within one of the options in each menu. The letters “uSEr” (the main menu) will then appear in the display. Press the UP and Down keys again for 3 seconds to exit the menu. A short explanation is also listed in each box of the figure. For further details, consult the descriptions in the following sections.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.8

Overview of Menu Functions

uSEr

SETUP (StuP)

-ti-

inFo

FAn Timer for the fan

ti.St Timer setting

Fn.SP Fan speed

vEr Version number

hEAt Timer for the heat

St.St Start set

tn-1 Calibrate value

rESt Restore default

A-St Auto set

hour displays show time

tn-2 Calibrate value

R232 Data logging

u-on* uv-light start time

tn-3 Calibrate value

SP* Single/Dual Set-Point

u-oF* uv-light end time

tn-L/tn-4 Calibrate value

unit °C or °F

tn-5 Calibrate value

tn-6 Calibrate value

tn-t Calibrate value

hS-1* Calibrate value

hS-2* Calibrate value

*not on all models

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

6.9

User Menu (uSEr)

ACTION

KEY

DISPLAY

Press and hold both the UP and DOWN keys for 3 seconds to enter the menu. The first main menu “uSEr” will appear in the display. Press the SP key once to enter the “uSEr” menu. Press the DOWN key to move to the next main menu. Press and hold both the UP and DOWN keys for 3 seconds to exit the menu.

6.9.1

Timer for the Fan (FAn)

The Fan option is used for the fan 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 fan function is ON, the fan will automatically turn on at 8:00 AM using 24-hour clock.

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INSTRUCTION MANUAL FOR K-SYSTEMS L100 SERIES WORKSTATIONS (English)

Follow these steps to navigate in the FAN (FAn) option. ACTION

KEY

DISPLAY

Press and hold both the UP and DOWN keys for 3 seconds to enter the menu. The menu “uSEr” will appear in the display. Press the SP key once, the “FAn” option appears in the display.

Press and hold the SP key to change the values. While holding the SP key in, press either the UP or DOWN key to select between OFF, FAST or SLOW. When the required setting is activated, release the SP key. Press and hold both the UP and DOWN keys 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. If you are setting the fan to fast "-FA-", the fast speed for the fan will be activated at the St.St time. If you are setting the fan to slow "-SL-", the slow speed for the fan will be activated at the St.St time. (When the fan is set to "-FA-" or "-SL-", a dot shows in the right side of the display). For example: If St.St is set up to 8.00 and function is set to "-FA-", the fan will automatically turn on at 8:00 AM.

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