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CUBE-TCF-01-09
Low Temperature Plasma Sterilizer
■ EN □ ES □ CS □ DA □ DE □ ET □ EL □ CZ □ RO □ MT □ RO □ PT
Safety Precautions: This is to protect the safety of users and prevent property damage.
Please fill in the model name of the product and Serial No. for more convenience when receiving an A/S.
After reading it, keep it in a place where people who use the product can always see it.
Rev. Date : 2021. 11. 20
User Manual
Model name : CB-Z007C
Brand name : EXPlasma Z7
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Table of Contents
Summary of Contents for Cube EXPlasma Z7
- Page 1 Low Temperature Plasma Sterilizer Model name : CB-Z007C Brand name : EXPlasma Z7 ■ EN □ ES □ CS □ DA □ DE □ ET □ EL □ CZ □ RO □ MT □ RO □ PT Safety Precautions: This is to protect the safety of users and prevent property damage.
- Page 2 ※ Revision History Rev. No Rev. Date Reason for Revision Rev.0 31.Oct.2019 Establishment Rev.1 21.May.2020 Corrective action for CE/MDD 1 audit Rev.2 20.Jul.2020 Corrective action for CE/MDD 2 audit Rev.3 10.Sep.2020 Revision of Intended use Change of European Representative Rev.4 11.Oct.2021 Change the number of sterilant code (7 digits ->...
- Page 3 ※ Symbol Information Symbols Description Symbols Description Manufacturer The date of manufacture Authorized representative Serial number in the European Community Batch code Warning, hot surface General warning sign General Prohibition sign Attention, consult WEEE wheeled bin accompanying documents Stepping prohibited Sitting prohibited Pushing prohibited Temperature limitation...
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Page 4: Table Of Contents
◆ Table of Contents EXPlasma Z7 - Intended use ----------------------------------------------------------------------------------------- - Overview ----------------------------------------------------------------------------------------- - Operation principle ----------------------------------------------------------------------------------------- - Device Overview ----------------------------------------------------------------------------------------- - Appearance ----------------------------------------------------------------------------------------- - Accessory and Component ----------------------------------------------------------------------------------------- - Dimension ----------------------------------------------------------------------------------------- Precautions - Precautions for use ----------------------------------------------------------------------------------------- - Precautions on careless use... -
Page 5: Explasma Z7
◆ EXPlasma Z7 ◆ EXPlasma Z7 - This is a ‘class IIb’ medical device, low temperature plasma sterilizer. - Be sure to thoroughly understand how to use this device before using it. - If you have any questions about how to set and use modes, please contact the local distributor. -
Page 6: Overview
◆ EXPlasma Z7 Overview The EXPlasma Z7(CB-Z007C) is a Low Temperature Plasma Sterilizer. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method. The Low Temperature Plasma sterilizer will sterilize both metal and nonmetal medical devices at low temperature. -
Page 7: Device Overview
◆ EXPlasma Z7 ◆ EXPlasma Z7 Device overview Name Image Description Main body of the device. Main body Device operation, sterilization mode setting can be (CB-Z007C-00) controlled from touch screen. Accessories (An accessory is intended to support the performance of one or more devices.) -
Page 8: Appearance
◆ EXPlasma Z7 ◆ EXPlasma Z7 Appearance Main body(CB-Z007C-00) Name Description Door Switching unit for injecting sterilized targets into the chamber 5" TFT LCD Set product behavior and monitor progress AC Inlet Power input: AC 230 V, 50 Hz (Fuse spec: AC 250 V,6 A x 2ea) -
Page 9: Accessory And Component
◆ EXPlasma Z7 ◆ EXPlasma Z7 Accessory Sterilant(CB-Z007C-01) Name Description Sterilant Hydrogen peroxide (H2O2) wt 50% Component Tyvek Pouch(CB-Z007C-02) Name Description If you sterilize after sealing the pouch, the sterilization condition Tyvek Pouch will last about 3 months. - Page 10 ◆ EXPlasma Z7 ◆ EXPlasma Z7 Component Power cord(CB-Z007C-03) Name Description Power Connecting Power plug connected to the power outlet. Plug Connecting plug Power input plug for connection to this equipment. EXPlasma tray(CB-Z007C-04) Name Description EXPlasma tray Tray for placing medical devices to be sterilized...
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Page 11: Dimension
◆ EXPlasma Z7 ◆ EXPlasma Z7 Dimension(mm) Main body Outward appearance Chamber W330 mm x H90 mm x D220 mm W390 mm x H280 mm x D440 mm Weight : 30kg Chamber capacity : 7 liter Accessory Sterilant(Hydrogen peroxide (H2O2) solution) Dimensions : Ø... - Page 12 ◆ EXPlasma Z7 ◆ EXPlasma Z7 Component Tyvek Pouch Dimensions : W: 75 mm, L: 1000 mm Weight : 720 g Power cord Dimensions : 3000 mm Weight : About 200 g...
- Page 13 ◆ EXPlasma Z7 ◆ EXPlasma Z7 Component EXPlasma tray Dimensions : W: 300 mm, D: 185 mm, H: 55 mm Weight : 260 g...
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Page 14: Precautions
◆ Precautions This is to protect your safety and prevent property. Be sure to read carefully and use the product correctly. Warning - Failure to comply with the safety precautions may result in death or serious injury to the user. Caution - Failure to comply with the precautions may result in personal injury or property damage. -
Page 15: General Precautions
◆ EXPlasma Z7 ◆ Precautions General precautions caution When the sterilization process is Do not force the Chamber door completed, the inside of the open while the Sterilizer is chamber of the sterilizer is hot operating. (below 60 ℃), so be careful before touching the inside of the chamber or door. -
Page 16: Precautions For Installation
◆ Precautions Precautions of installation warning Place the product at a Do not install the product on distance from the wall to a rocking shelf, sloping place, ensure proper ventilation. unstable place, or where It may cause fire due to vibration is severe. -
Page 17: Appearance
◆ EXPlasma Z7 ◆ Appearance Specifications Category Contents W390 × H280 × D440 Dimension W330 × H90 × D220 Chamber dimension Available Capacity : 7 L Material: Aluminum 50~60 ℃ Sterilization temperature Vacuum range within 3 to 760 Torr Initial vacuum (below 20 Torr), diffusion process... -
Page 18: Name Of Parts
Power input: AC 230 V, 50 Hz (Fuse spec: AC 250 V,6 A x 2ea) Fuse holder/Fuse Protection of products when over-current is applied Sterilant insertion Insertion for installing sterilant ◆ EXPlasma Z7 ◆ UI Desciptions Sterilization Mode Sterilization condition Mode... -
Page 19: Operation Panel
◆ EXPlasma Z7 ◆ UI Desciptions Operating panel Mode Functions Flash mode Surface sterilization - for simple shape medical devices Penetration Sterilization - for medical devices with complex Standard mode tubular and heavy structures Echo mode Standby / Power save mode... -
Page 20: Ui Description
◆ EXPlasma Z7 ◆ UI Desciptions UI descriptions Category Descriptions Initial After power-on, initial display Standby mode display for pre-heating of Pre-heating chamber, vaporizer, cover. Preparation mode for normal sterilization. Preparation It takes about 10 minutes. Cancellation button disabled after process penetration of sterilant. - Page 21 ◆ EXPlasma Z7 ◆ UI Desciptions UI descriptions Category Descriptions Sterilization mode selection screen. Sterilization mode When the "Start" button is touched, (Standard Mode) sterilization proceeds. sterilization progress and remaining time. Sterilization mode Cancellation button disabled (Standard Mode) after penetration of sterilant.
- Page 22 ◆ EXPlasma Z7 ◆ UI Desciptions UI descriptions Category Descriptions Echo mode Echo mode display screen. (Power Saving Touch "sterilization mode" to return to sterilization selection mode. mode) The Setup mode consists of Self Diagnosis, Setup mode LCD touch calibration, Cartridge code, Reprint item.
- Page 23 ◆ EXPlasma Z7 ◆ UI Desciptions UI descriptions Category Descriptions Enter the 8-digit code on the sterilant Setup mode cartridge. When finished, press the OK (Cartridge code) button. If an incorrect code is entered, "Invalid code" is displayed below. Please re-enter Setup mode the correct code.
- Page 24 ◆ UI Desciptions UI descriptions Category Descriptions No sterilant installed. If no sterilant is found after the check, please install a new sterilant sterilant. Please check the instructions on the screen. Door After confirming, please proceed Check sterilization process again. Please check the instructions on the screen.
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Page 25: How To Use
EXPlasma product and the other side to the main power terminal. Install the sterilant in the sterilizer. First, power on the EXPlasma Z7. If no sterilant cartridge is installed, the LCD prompts you to insert the sterilant cartridge. - Page 26 ◆ How to use Operations Open the upper door of EXPlasma. Open the door at the top of the product. Remove the tray. Remove the tray inside. Place the object in the EXPlasma tray for sterilization. Place the medical device to be sterilized in the tray and reinsert the tray inside the chamber.
- Page 27 ◆ EXPlasma Z7 ◆ How to use Operation Touch the action button of EXPlasma. Touch the desired mode on the front LCD panel of the product. Sterilization is automatically performed as a warning tone sounds. Check the sterilization completion The sterilization process is completed with an audible warning to the end of the sterilization.
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Page 28: Sterilization Completion Check
◆ How to use ◆ EXPlasma Z7 Sterilization completion check Color change((△) Color change (O) Color change (X) Re-sterilization sterilization completed Re-sterilization How to keep and manage after use (1) Clean according to the instructions in the manual. (2) Turn off the power before cleaning the exterior. -
Page 29: After-Sales Service Regulations
◆ After-Sales service regulations - Warranty The warranty of the product is 36 months from the date of purchase. The warranty of the Free product is calculated based on the purchase date. The purchase date is confirmed by the product warranty, purchase receipt, initial data of the internal recording device, online warranty server registration, and the initial forwarding date of the local distributor. -
Page 30: Maintenance
◆ Maintenance Contents Implementation cycle Checking the sterilization Every time sterilized status using CI Sterilizer enclosure cleaning Once a week Checking the sterilization Once a week status using BI Checking the inner tray of the Once a month sterilizer Replacing fuse Once a year - Do not use inappropriate solution for cleaning applied parts including all exterior surfaces such as... -
Page 31: Life-Time Of Critical Component List
◆ Life-time of critical component list - Hydrogen peroxide (H2O2) solution □ Expected Service Life(ESL) 1. Life cycle of Plasma Sterilizer 10,000 times - Sterilization count : 2 cycles for Standard mode (per 1 day) - 10,000 times / 2 cycles = 5,000 days ∴... -
Page 32: Label And Packaging
◆ Label and Packaging Product Label Packaging Label... - Page 33 ◆ Label and Packaging Accessory Label Component Label...
- Page 34 ◆ Label and Packaging Packaging information - Packaging Unit : 1 Set - Packaging material : Carton Box, PE Foam - Packaging Size : 460(W) X 380(H) X 510(D) mm...
- Page 35 ◆ Label and Packaging Sterilant Box Size : 110(W) x 110(H) x 70(D), mm...
- Page 36 ◆ Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic immunity The CB-Z007C is intended for use in the electromagnetic environment specified below. The customer or the user of the CB-Z007C should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance...
- Page 37 ◆ Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic immunity The CB-Z007C is intended for use in the electromagnetic environment specified below. The customer or the user of the CB-Z007C should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance...
- Page 38 ◆ Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic immunity The CB-Z007C is intended for use in the electromagnetic environment specified below. The customer or the user of the CB-Z007C should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance...
- Page 39 ◆ Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic immunity The CB-Z007C is intended for use in the electromagnetic environment specified below. The customer or the user of the CB-Z007C should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance...
- Page 40 ◆ Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration – electromagnetic immunity The CB-Z007C is intended for use in the electromagnetic environment specified below. The customer or the user of the CB-Z007C should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance...
- Page 41 CUBE Instrument Inc. EXPlasma B133, 65, Techno 3-ro, Yuseong-gu, Daejeon, Republic of Korea Tel : +82-42-933-0109, FAX : +82-42-933-0105 www.explasma.com MDSS GmbH Schiffgraben 41, 30175 Hannover, GERMANY...
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