Tissue-Tek TEC 6 Cryo Module Operating Manual Aug 2018

The brand names of products that have been registered or trademarked by and are owned by Sakura Finetek USA, Inc., Sakura Finetek Japan Co., Ltd., and Sakura Finetek Europe B.V. appear here: Sakura Tissue-Tek

© 2018 Sakura Finetek Japan Co., Ltd. All Rights Reserved Printed in Japan.

Please visit our website www.sakura-finetek.com Manufactured for: Sakura Finetek USA, Inc., Torrance, CA 90501 U.S.A. Sakura Finetek Europe B.V., 2408 AV Alphen aan den Rijn, NL Sakura Finetek Japan Co., Ltd., Tokyo, 103-0023, Japan Manufactured by: Sakura Seiki Co., Ltd., Nagano, 387-0015, Japan 2

Table of contents 1. Introduction 1.1 1.2 1.3 1.4

1.5 1.6

Intended Use……………………………………………………………7 Safety Precautions……………………………………………………8 Precautions for Use………………………………………………… 13 Overview of the Instrument……………………………………… 14 1.4.1 Instrument Configuration………………………………… 14 1.4.2 Specifications……………………………………………… 15 Accessories………………………………………………………… 16 1.5.1 Standard Accessories (Cryo Module)…………………… 16 Description of Instrument Parts………………………………… 17 1.6.1 Instrument (Front Side)…………………………………… 17 1.6.2 Instrument (Rear Side)…………………………………… 17

2. Installation 2.1

2.2

2.3

Installation…………………………………………………………… 19 2.1.1 General Information on Installing the Instrument……… 19 2.1.2 Installation Environment…………………………………… 19 2.1.3 Unpacking Method of the Cryo Module………………… 20 2.1.4 Installation Method………………………………………… 22 Setting Up the Instrument………………………………………… 25 2.2.1 Temperature Setting for Each Part of the Instrument… 25 2.2.2 Setting the Schedule of the Auto Operation (with the Auto Cryo Mode)…………………………………………… 28 Operational Overview……………………………………………… 30 2.3.1 Operation Method………………………………………… 30

3. Explanation of Operations 3.1

Explanation of Operations………………………………………… 33 3.1.1 Basic Operations…………………………………………… 33

4. Error Log 4.1

Error Log…………………………………………………………… 35 4.1.1 Viewing the Error Log……………………………………… 35

5. Troubleshooting 5.1

Troubleshooting…………………………………………………… 37 5.1.1 Instrument Condition and Solution……………………… 37 5.1.2 Message Window…………………………………………… 38 5.1.3 What to Do Following a Power Outage………………… 44 3

5.2

Cleaning……………………………………………………………… 45 5.2.1 Inspection and Cleaning…………………………………… 45 5.2.2 Cleaning the Cryo Module………………………………… 45

6. Replacement Parts 6.1

Replacement Parts………………………………………………… 47 6.1.1 Cryo Module ……………………………………………… 47

7. Glossary of Terms 7.1

Glossary of Terms………………………………………………… 49

4

Table of contents

5

1. Introduction

1. Introduction 1.1 Intended Use The Tissue-Tek® TEC™ 6 Cryo Module (hereinafter referred to “the instrument”) is intended to embed processed human or animal tissue in paraffin by cooling blocks which contain tissues and paraffin on cassettes after dispensing molten paraffin. This instrument is used to facilitate as part of steps to produce tissue specimens for histological studies and tests conducted in the fields of pathology, anatomy, clinical pathology, etc. The Cryo Module is controlled through the Embedding Module, so it must be connected with a control cable. This document is the Operating Manual for the Cryo Module. For more detail on how to operate the instrument, refer to the Operating Manual for the Tissue-Tek® TEC™ 6 Embedding Module. In the case of disposal or maintenance of the instrument, comply with national, regional and local laws and regulations for equipment containing hydrofluorocarbon to ensure proper management and collection of HFC. Carefully read this Operating Manual and use the instrument correctly so that its performance can be utilized fully. Any other use of this instrument is considered improper operation.

7

1.2 Safety Precautions Designate the "Instrument Control Manager." •

Operation of the instrument requires expert knowledge of the target application, method of use, and so on. Therefore, to use the instrument correctly and safely, designate an "Instrument Control Manager."

•

When the instrument is delivered, the Instrument Control Manager should receive explanation on the handling of the instrument directly from the staff trained in the instrument or distributor.

Before using the instrument, read the "Safety Precautions" to ensure the correct use of the instrument. The cautionary instructions provided herein are intended to ensure that the instrument will be used safely in a manner preventing operator from injury and property damage. These instructions provide important safety information that must be needed at all times. In this manual, instructions pertaining to different levels of potential hazards are classified and indicated respectively as danger, warning, caution and note. The definition of each hazard is defined below. DANGER

DANGER pertains to a potential hazard where failure to observe the specified instruction may result in death or serious injury of the user or another person.

WARNING

WARNING pertains to a potential hazard where failure to observe the specified instruction may result in a serious injury of the user or another person.

CAUTION

CAUTION pertains to a potential hazard where failure to observe the specified instruction may result in damage to the instrument or other property, or affect the process results. NOTE pertains to an item to pay attention to or other useful information.

8

1. Introduction The symbols used on the labels attached to the instrument are explained. The labels bearing one of the following symbols provide particularly important information you must know in order to ensure safety of the operator, improve work efficiency and protect the instrument from damage. Be sure to check these labels and understand the specified instructions before commencing your work A label bearing this symbol specifies an action that must be taken. Always follow the instruction. A label bearing this symbol specifies a prohibited item. Always follow the instruction. A label bearing this symbol specifies a precaution. Wrong handling against the instruction may potentially expose the operator to danger or damage the instrument, so be sure to follow the instruction. A label bearing this symbol is provided near a high-temperature area. Exercise caution against burns caused by high temperatures. If any biologically hazardous substance is handled, follow applicable regulations or guidelines in your country or region to ensure safety.

9

WARNINGS: •

Follow instructions in this operating manual. If the instrument is not used properly, it may induce failure of the instrument, injury to operators, and/or damages to facilities.

•

Observe the instructions described in the Operating Manual. Failure to do so will lead to instrument failure, a risk of injury to the user and damage to facilities.

•

Do not disassemble or modify the instrument. Do not disassemble or modify the instrument except for the areas specified in this manual.The instrument may malfunction or cause accident, thus creating a dangerous situation.

•

Do not wet the instrument. Do not wet the instrument except for the areas specified in this manual. If the instrument gets wet, electrical current leak may occur and cause fire or electric shock.

•

Do not operate the switches with a wet hand. Failure to observe the instruction may result in electric shock.

•

Do not connect/remove the power plug with a wet hand. Failure to observe the instruction may result in electric shock.

•

When connecting/removing the power plug, do so by holding the plug. Connecting/removing the power plug by holding parts other than the plug may cause fire or electric shock.

•

Do not damage the power cord. Do not forcibly bend, pull, twist or bundle the power cord. If the damaged power cord is used, fire or electric shock may occur. If the power cord or power plug has scratches or other abnormalities, contact a Sakura instrument distributor or representative.

•

Check the power cord and electrical outlet for damage and accumulated dust periodically. Failure to do so may cause fire depending on the condition.

10

1. Introduction CAUTIONS: •

Connect the power plug to an electrical outlet with grounding terminals. Connect the power plug to a dedicated electrical outlet with grounding bar. If the power plug is not grounded, electric shock may result.

•

Use the supplied power cord. If the supplied power cord is not used, electric shock or failure may result. In particular, use of a power cord of lower capacity may cause fire or electric shock.

•

Turn off the power before cleaning the instrument. Unless otherwise instructed in this document, turn off the power before cleaning the instrument. If the instrument is cleaned while the power is still on, an accident may occur.

•

Turn off the power if the instrument behaves abnormally. Should you notice the instrument giving off a foul smell or abnormal noise, or otherwise behaving abnormally, remove the power plug and contact a Sakura instrument distributor or representative.

•

Do not remove the warning/caution labels. Do not remove the warning/caution labels attached to the instrument. Without these labels, the operators cannot be reminded of the necessary warning/cautionary information in the day-to-day handling of the instrument, which may result in unexpected problems.

•

Perform periodic inspection of the instrument every 6 months. Perform periodic inspection of the instrument every 6 months to ensure safe use of the instrument and maintain its performance. For details on periodic inspection, contact a Sakura instrument distributor or representative.

•

When moving the instrument, hold it on each side or the back side. When moving the instrument, hold it on each side or the back side. Also, two persons should work together to carry the instrument, because the Cryo Module weighs approx. 22 kg. *Do not hold the Cryo Module with your hands on the front side. Doing so may damage the resin part and cause injury or the instrument to fall.

11

•

Precautions when installing the instrument (Installation) Do not put down the instrument in an unstable place or on a floor or surface with insufficient strength.

•

How to remove dew condensation water. Remove dew condensation on the cooling plate before dew condensation water flows out of the frame. (See 5.2.2 Cleaning the Cryo Module.)

•

Stay away from the instrument during earthquake. The instrument may fall over and cause injury.

12

1. Introduction 1.3 Precautions for Use CAUTIONS: •

Precautions when installing the instrument (installation) Do not put down the instrument in an unstable place or on a bench or surface with insufficient strength. Doing so may cause injury. Install the instrument in a location meeting the installation conditions. Dew condensation, etc. may cause malfunction. (See 2.1.2 Installation Environment)

•

Precautions when cleaning (Caution for chemical agent) When cleaning, do not use chemical agents other than those specified. Unauthorized chemical agents may damage the instrument or cause health issues. Also, wear protective gears when cleaning.

•

Precautions for infections When using the instrument in a hospital, be careful not to cause secondary infections.

•

Caution on electromagnetic environment The instrument is designed to operate in normal electromagnetic environment. In any other electromagnetic environments, use the instrument on user’s own responsibility.

•

Detaching a plug from an electrical outlet A power switch of the instrument must be off before pulling a plug.

Precautions for Prevention of Failures •

When cleaning the instrument, do not use any organic solvents (xylene). The coatings and materials of the exterior panels may deteriorate.

•

Do not put anything on top of the instrument. Failure or unexpected problems may occur.

•

Do not extend the power cord using a different cord, etc. Connect the instrument power cord directly to an electrical outlet instead of extending it using a different cord, etc. Especially in the case of the Cryo Module, if the power cord is extended and connected, the supply voltage may drop and the compressor may stop working.

•

Do not block the air ventilation panel on the rear side. Doing so will decrease cooling performance and cause instrument failure.

13

1.4 Overview of the Instrument 1.4.1 Instrument Configuration The instrument comprises of the cooling plate that cools/solidifies the embedded paraffin blocks.

CAUTION

CAUTION: The Cryo Module is controlled by the Embedding Module which is connected to the Cryo Module by the control cable. The Cryo Module cannot be used alone.

14

1. Introduction 1.4.2 Specifications General name

Paraffin-embedded block preparation system

Brand name

Tissue-Tek® TEC™ 6 Cryo Module

Model

TEC 6-CM-J0

TEC 6-CM-A1

TEC 6-CM-E2

TEC 6-CM-JC2

Product code

5105

5109

5113

5117

Manufacturing license number

20B2X00014000036

-

-

-

Dimensions

330 (W) × 617 (D) × 377 (H) mm (Cold plate size:300 (W) × 370 (D))

Weight

Approximately 22 kg 230 VAC 50 Hz 1.0 A

230 VAC 50 Hz 1.0 A

Rated power supply

100 VAC 50/60 Hz 3.0 A

115 VAC 60 Hz 2.0 A

Heated area & -10 to 0 °C Program-mable range Temperature Lowest temperature control achievable

-5°C ± 3.5°C or below (Room temperature of 25°C, with no wind, measured at a center of the cold plate under no loaded environment)

Time to reach at a setting -5°C

Within 30min after started to operate (Room temperature of 25°C, with no wind, measured at a center of the cold plate under no loaded environment) Overcurrent protection (circuit protector) Overload protection for compressor (overload protection relay) Detection of fan rotation (built-in fan sensor)

Safety device Location of the Instrument Required facilities

Indoor use

Voltage

100 VAC ±10%

115 VAC ±10%

230 VAC ±10%

230 VAC ±10%

Frequency

50/60 Hz

60 Hz

50 Hz

50 Hz

Capacity

15 A or higher

15 A or higher

10 A or higher

10 A or higher

Ambient temperature

10 to 35°C

Operating Relative humidity environment Altitude

30 to 85% (non-condensing) 2,000 m or lower

Ambient temperature Storage environment Relative humidity

30 to 85% (non-condensing)

Overvoltage category

II (2)

Transient overvoltage up to the level

1500V

Electromagnetic environment

Normal electromagnetic environment

Pollution degree *

2 (*per IEC61010)

Noise*

60 dB or less (A-weighted level) (*per JIS Z8737-2:2000)

Vibration/Drop

Refrigerant

Vibration test per JIS Z 0200, JIS Z 0232

Coolant Type

Hydrofluorocarbon (HFC)

Coolant No.

HFC-134a

GWP value

1430

Amount

110 g

105 g

105 g

105 g

Pharmaceutical Affairs Law

FDA Class1 IVD

CE Marking EMC/LVD/RoHS Directive

CFDA

JIS C 1010-1:2014 JIS C 1010-2-101:2013

UL61010-1; 3rd ed: 2012 CSA-C22.2 No.61010-12012 IEC61010-2-010:2014 IEC61010-2-101:2015

EN 61010-1-2010

GB 4793.1-2007 (IEC610101:2001) GB 4793.6-2006 (IEC61010-2-010:2005) YY 0648-2008 (IEC610102-101:2002)

JIS T 14971:2012 IEC 62366:2007

-

-

-

Medical equipment software

JIS T 2304:2017

-

-

-

Quality management

ISO13485:2003

-

-

-

JIS C 1806-2-6:2012

-

EN 61326-1:2013

GB/T 18268.1-2010 (IEC61326-1:2005) GB/T 18268.26-2010 (IEC61326-2-6:2005)

-

-

EN 50581:2012(RoHS)

-

Law

Electrical safety evaluation Regulatory and applicable standards

-10 °C to 60 °C

Risk management

Electro-magnetic compatibility Others

(TEC 6-CM-A1)

(TEC 6-CM-E2)

15

1.5 Accessories 1.5.1 Standard Accessories (Cryo Module) [TEC 6-EM-J0]

[1]

[TEC 6-CM-E2(JC2)]

Item name [1]

[2]

Power cord

Control cable Operating Manual

[2]

[TEC 6-CM-A1]

Product code

Quantity TEC 6-CM-J0

TEC 6-CM-A1

TEC 6-CM-E2

A4010527

1

-

-

-

A4010539

-

1

-

-

A4010535

-

-

1

1

A4120001

1

1

1

1

-

1

1

1

1

16

TEC 6-CM-JC2

1. Introduction 1.6 Description of Instrument Parts 1.6.1 Instrument (Front Side)

[1]

[2]

[1] Power switch A switch for the main power supply. The lamp is turned on while power is supplied. [2] Cooling plate A cooling plate that cools/solidifies the embedded paraffin block.

1.6.2 Instrument (Rear Side)

[3] [1]

[2]

[1] Power inlet Connect the power cord here. [2] Control cable connector Used to connect to the Embedding Module. [3] Intake and exhaust openings Openings of air ventilation for compressor.

17

2. Installation

2. Installation 2.1 Installation 2.1.1 General Information on Installing the Instrument This section provides information on determining a location for and installing the instrument. Installation should be performed by trained staff for the instrument. This instrument must be installed correctly to ensure proper operation and service. Read this Operating Manual carefully before operating the instrument. Follow all instructions provided in this document carefully. CAUTION:

CAUTION

This instrument is a precision instrument and must be handled with care. If the instrument is handled in a rough manner or dropped, its internal components may malfunction or get damaged. Always exercise due care when handling the instrument.

2.1.2 Installation Environment Install the instrument in a location meeting the following conditions: •

Free from fire or ignition sources nearby

•

Not exposed to direct sunlight

•

A horizontal level and stable surface area

•

Subject to minimum vibration

•

Protected from water splashes

•

Away from volatile substances or flammable materials

•

Away from corrosive chemicals (acids, alkalis, etc.)

•

Free from equipment that consumes high voltage or large current Example) Large refrigerator, ultrasonic cleaner, cooling centrifuge, etc.

•

The ambient temperature and humidity meet the following use environment values: Ambient temperature: 10 to 35°C Relative humidity:

30 to 85 % (non-condensing)

19

2.1.3 Unpacking Method of the Cryo Module How to remove the instrument from the packing box that has been carried in, and remove the protective materials, is explained in this document. To perform each work safely and correctly, be sure to follow the procedure specified herein. CAUTION

CAUTIONS: • Confirm before unpacking the instrument, that the packing materials have not been damaged due to external forces applied during transportation. • Unpacking of the instrument should be performed by qualified service staff. • The instrument itself weighs approx. 22.0 kg. At least two people should work together when lifting or moving the instrument. • When lifting the instrument, bend your knees fully or otherwise assume a natural posture. Unpacking the Instrument 1. Cut the two bands with a cutting knife, etc. and remove the cap. キャップ Cap

バンド Band

2. Pull up the top pad to remove. 天面パッド

Top pad

スリーブ Sleeve

NOTE: Remove the top pad while holding down the sleeve.

20