2.

Pushing the button to Sterilizing agent chamber

Instruction For Use
door, Removing the empty Sterilizing Agent

0120 Feature

Instruction For Use The LOWTEM Crystal Sterilizing Agent is used for
sterilize medical devices to a Sterility Assurance
LOWTEM Crystal Sterilizing Agent Level(SAL) of 10-6 of LOWTEM Crystal Series
3. Replacing New Sterilizing agent. Locate a new
using plasma sterilizer of LOWTEM Crystal Series
sterilizing agent tank into the HPS supply unit,
Sterilization of this equipment using Sterilizing
matching the hole on the bottom of the tank,
agent provides the greatest level of assurance
and push it down to fit into the sterilant supply
that sterilization loads are free of viable
pot.
microorganisms.
LowTem Co., Ltd. 4. Close the Door.

#A-302, Gunpo IT Valley, 17, Shelf Life

Gosanro 148beon-gil, Gunpo-si, 5. If you want to check the number of
12 months from the date of manufacture
Gyeonggi-do, 435-833, KOREA remaining cycles after installation:
60 days from the installation into the machine
Tel :+82(31) 427 0792 1) Go to Monitor and check the remaining
Fax : +82(31) 427 0793 Storage Conditions cycle numbers on the monitor.

2 ~ 8 ℃ (36 ~ 46 ℉)

EC Representative Procedure
DongBang AcuPrime 2) Or, go to SetupSterilizing Agent, and check
1. If you recognized the H2O2 remaining count is
1 forrest Units, Hennock Road East, the remaining cycle numbers, lot number,
“0” and the alarm message pops up on the
Marsh Barton, and expiry days.
monitor, the LOWTEM Crystal Sterilizing Agent
Exeter EX2 8RU, U.K
should be changed.

REF CSA001 LTCSA001_Rev.01(Nov2014)

 WARNING! CONCENTRATED HYDROGEN WARNING! HYDROGEN PEROXIDE MAY BE
Personal Safety and First Aid
PEROXIDE IS TOXIC PRESENT.

WARNING! HYDROGEN PEROXIDE IS Ingestion of hydrogen peroxide may be life threatening. If Wear chemical resistant latex, PVC (vinyl), or nitrile gloves

CORROSIVE. swallowed, call a “poison control” center or physician whenever handling, a used hydrogen peroxide tank, an

Concentrated hydrogen peroxide is corrosive to skin, eyes, immediately for treatment advice. Have the person drink ejected tank, a load after a cycle cancellation, or if any

nose, throat, lungs, and the gastrointestinal tract. Always plenty of water if the person is able to swallow. Do not give moisture is noted on a load following a completed cycle.

wear chemical resistant latex, PVC (vinyl), or nitrile gloves anything by mouth to an unconscious person. Do not induce Hydrogen peroxide liquid may be present on the load or in

when removing items from the sterilizer following a cancelled vomiting unless instructed to do so by the poison control the chamber.

cycle or if any moisture is noted on items in the load center or physician.

following a completed cycle.

Sterilizing Agent Handling
WARNING! RISK OF EYE INJURY.

WARNING! HYDROGEN PEROXIDE IS AN Direct hydrogen peroxide contact with eyes can cause WARNING! HYDROGEN PEROXIDE MAY BE

OXIDIZER irreversible tissue damage. If contact with eyes occurs, hold PRESENT.
Hydrogen peroxide is a strong oxidizing agent and poses a the eyes open and flush with large amounts of water for at Do not remove the plastic wrapper from the hydrogen

hazard for fire, explosion, or container rupture. Avoid least 15-20 minutes. Remove contact lenses, if present, and peroxide tank if any liquid is visible inside. Call the LOWTEM.

allowing hydrogen peroxide to contact organic materials, then continue rinsing the eyes. Consult a physician

including paper, cotton, wood, or lubricants. Do not use or immediately after flushing the eyes. WARNING! HYDROGEN PEROXIDE MAY BE
store near heat or open flame. Shoes, clothing, or other PRESENT.
combustible material that have come into contact with WARNING! RISK OF RESPIRATORY Hydrogen Peroxide Tank with unused hydrogen peroxide are

hydrogen peroxide must be immediately and thoroughly IRRITATION hazardous waste as defined by the US Environmental

rinsed with water to avoid a potential fire hazard. In case of Inhalation of hydrogen peroxide mist can cause severe Protection Agency and should be disposed of accordingly. If

fire, use only water to extinguish. irritation of lungs, throat, and nose. If inhalation occurs, move it is necessary to handle a used tank, wear chemical resistant

the person to fresh air. If the person is not breathing, call for latex, PVC (vinyl), or nitrile gloves. Do not touch gloves to

emergency medical attention, or an ambulance, then give face or eyes.

artificial respiration, preferably mouth-to-mouth, if possible.

Consult a physician immediately.

REF CSA001 LTCSA001_Rev.01(Nov2014)

 1. Prior to incubation, the Biological
Instruction For Use Indicator must be activated by crushing
its internal glass medium ampoule to

Instruction For Use INDICATIONS FOR USE allow the color-change medium. Place
the Biological Indicator into the left or
The LOWTEM Crystal Biological Indicator is intended
right side of the activation cavity and flex
LOWTEM Crystal Biological Indicator for use by healthcare providers and medical device
the indicator to the opposite side.
manufacturers for monitoring of the Sterilization
2. Label the LOWTEM Crystal Biological
Process in the LOWTEM Series. The LOWTEM Crystal
Indicator appropriately (date, cycle
Biological Indicator is designed to accompany medical
number, etc.).
instruments and devices placed in the sterilizer.

C. Incubate the processed Biological Indicator in

LowTem Co., Ltd.
the 58 ± 2C incubator.
#A-302, Gunpo IT Valley, 17, PLACEMENT AND PACKAGING: Note: If the LOWTEM sterilization cycle
Gosanro 148beon-gil, Gunpo-si, Package the LOWTEM Crystal Biological Indicator in a cancels (aborts), the LOWTEM Crystal
manner, consistent with the items being sterilized. Biological Indicator should be discarded as
Gyeonggi-do, 435-833, KOREA
Place the LOWTEM Crystal Biological Indicator in the standard microbial waste. A new LOWTEM
Tel :+82(31) 427 0792
most challenging area for the sterilizing agent to reach. Crystal Biological Indicator should be used in
Fax : +82(31) 427 0793
the next cycle.

Manufacturer:
BIOLOGICAL TEST:
SPS medical Supply Corp.
A. Set up a 58 ± 2C incubator according to
6789 W. Henrietta Road Rush, NY manufacturer’s instructions, allowing the
14543 USA incubator to be heated up.

EC Representative B. After the sterilization cycle is completed,

remove the LOWTEM Crystal Biological
DongBang AcuPrime
Indicator from the sterilizer.
1 forrest Units, Hennock Road East,
Marsh Barton,
Exeter EX2 8RU, U.K

REF SBI001 LTSBI001_Rev.02(July 2016)

USE OF CONTROLS: INTREPRETATION OF RESULTS: STORAGE CONDITIONS:
A. Positive Control: Crush an unprocessed A. Compare the processed LOWTEM Crystal A. Store LOWTEM Crystal Biological
LOWTEM Crystal Biological Indicator and Biological Indicator with the Positive Control. Indicators at room temperature (15 to
place in the same incubator used for the 1. The absence of a color change in the 30C) under dry conditions.
processed LOWTEM Crystal Biological processed LOWTEM Crystal Biological
Indicators. It is recommended that a positive Indicator (i.e., media remains purple)
B. Do not store LOWTEM Crystal Biological
control be used with each LOWTEM indicates that the sterilization conditions
Indicators near any sterilizers or
sterilization cycle monitored by an LOWTEM were achieved in the LOWTEM sterilizer.
Crystal Biological Indicator. sterilizing agents such as ethylene oxide,
This is considered a Negative Result.
2. If the processed LOWTEM Crystal steam, hydrogen peroxide, acids, alkalis,
B. Negative Control: An unprocessed and Biological Indicator media changes color volatile antimicrobials or other oxidizers.
uncrushed LOWTEM Crystal Biological from purple to yellow and /or exhibits
Indicator can be used, if desired. If used, turbidity, this indicates that the
place Negative Control in the same incubator conditions necessary to achieve Monitoring Frequency
used for the processed LOWTEM Crystal sterilization in the LOWTEM sterilizer
A. Follow Policies and Procedures of each
Biological Indicators and Positive Control. were not achieved. This is considered a
facility which should specify a biological
Positive Result.
indicator monitoring frequency compliant
READOUT OF RESULTS: with professional association recommended
A. Observe each LOWTEM Crystal Biological B. If a Positive Result is observed, run another
practices and/or national guidelines and
Indicator media for color change from purple LOWTEM Crystal cycle with another LOWTEM
standards.
to yellow and/or for turbidity (indicating Crystal Biological Indicator.
B. As a best practice and to provide optimal
organism growth). Record results after 24 patient safety, LowTem recommends daily, or
hours. C. If two consecutive Positive Results are
at least weekly monitoring.
observed in the processed LOWTEM Crystal

B. Discard all LOWTEM Crystal Biological Biological Indicators, have the sterilizer
checked by the manufacturer and follow Expiration
Indicators immediately after final reading
current policy and procedures. If the second 18 months from date of manufacture
including the Positive Control as standard
microbial waste (autoclave waste for at least LOWTEM Crystal Biological Indicator is a

30 minutes at 121C(250℉)). Negative Result, run a third LOWTEM

sterilization cycle to confirm sterilizer
performance.

REF SBI001 LTSBI001_Rev.02(July 2016)

 Storage and Shelf Life
Instruction For Use
Store unopened and resealed packages
Product Description containing LOWTEM Crystal Chemical Indicator
Use LOWTEM Crystal Chemical Indicator Strip as Strips at normal room temperature [15~24°C
Instruction For Use an internal pack process indicator to verify (59~75°F)] and relative humidity(RH) < 50%.
exposure to vapor hydrogen peroxide in the
LOWTEM Crystal Chemical Indicator Strip
LOWTEM Crystal Sterilization Processes) LOWTEM Crystal Chemical Indicator Strips
contained in an unopened package have a 2 year
Instruction for Use shelf life from the date of manufacture when
stored at the recommended conditions. The
1. Carefully tear or use scissors at the tear expiration date is printed on the package label.
LowTem Co., Ltd.
notch at the top of the foil package to make
#A-302, Gunpo IT Valley, 17,
the initial opening. Remove only the number
Gosanro 148beon-gil, Gunpo-si,
of strips needed. Reseal the package.
Gyeonggi-do, 435-833, KOREA Single Use
2. Before use, confirm that the unprocessed
Tel :+82(31) 427 0792
chemical indicator is blue. If it is not blue, do
Fax : +82(31) 427 0793
not use.
3. Place the indicator in each peel pouch or
Manufacturer: 3M Health Care pack to be processed in the LOWTEM Crystal
St. Paul, MN 55144-1000 Sterilizers.
Made in U.S.A 4. Process the load according to the
manufacturer’s instructions.
EC Representative 5. After processing, the blue bar changes to the
DongBang AcuPrime color of the color match or pink. If the color
1 Forrest Units, Hennock Road East, change is not complete, inadequate exposure
Marsh Barton, to vapor hydrogen peroxide is possible. The
Exeter EX2 8RU, U.K pack should be returned for reprocessing.

REF CIS001 LTCIS001_Rev.01(July 2016)

 Instruction For Use
Storage and Shelf Life
Store LOWTEM Crystal Chemical Indicator Tape
Instruction For Use Product Description at normal room temperature [15~24°C(59~75°F)]
Use LOWTEM Crystal Chemical Indicator Tape to and relative humidity(RH) < 50%.
LOWTEM Crystal Chemical Indicator Tape secure packs and as an external pack indicator to
differentiate processed from unprocessed items LOWTEM Crystal Chemical Indicator Tape has an
when exposed to vapor hydrogen peroxide in the 18 month shelf life from the date of manufacture
LOWTEM Crystal Sterilizers. LOWTEM Crystal when stored at the recommended conditions.
Chemical Indicator Tape is suitable for use on The Expiration date is printed on the side of each
non-woven disposable wraps and peel pouches. roll core.
LowTem Co., Ltd.
#A-302, Gunpo IT Valley, 17,
Instruction for Use
Gosanro 148beon-gil, Gunpo-si,
1. Open the plastic package wrap that contains
Gyeonggi-do, 435-833, KOREA
the roll of tape and install in a tape dispenser.
Tel :+82(31) 427 0792 Single Use
2. Unwind an appropriate length of tape.
Fax : +82(31) 427 0793
3. Apply the tape using finger pressure along
the entire length of the tape to secure the
Manufacturer: 3M Health Care
pack.
St. Paul, MN 55144-1000
4. Repeat steps 2 and 3 for additional lengths
Made in U.S.A of tape that are applied to the pack.
5. After sterilization, verify that the indicator
EC Representative strips have turned pink.
DongBang AcuPrime 6. When the pack is ready for use, open the
1 Forrest Units, Hennock Road East, pack by breaking the tape at the point of the
Marsh Barton, fold flap. Do not remove tape from wraps in
Exeter EX2 8RU, U.K the operating room to guard against linting.

REF CIT001 LTCIT001_Rev.01(July 2016)

 Instruction For Use

1. Introduction
Instruction For Use Warning Refer to manual
LOWTEM Crystal Incubator is designed for58±2°C
LOWTEM Crystal Incubator (Geobacillus stearothermophilus) incubation of Caution
LOWTEM Crystal Biological Indicators. The
Cautions alert you to potential equipment
incubator features a built-in thermometer with LED
damage and hazards.
display, an integrated crushing cavity, and 15
incubation cavities. Note

LowTem Co., Ltd. Notes alert you to pertinent facts and

#A-302, Gunpo IT Valley, 17, conditions.
2. Safety Information
Gosanro 148beon-gil, Gunpo-si,
Gyeonggi-do, 435-833, KOREA Handle with caution.
Use Only as Directed
Tel :+82(31) 427 0792 The surface of the incubator may become hot to
Fax : +82(31) 427 0793 the touch. The incubator has been designed with • Indoor use only.
function, reliability, and safety in mind. It is the • Temperature 10°C to 35°C.
user’s responsibility to install it in conformance • Maximum relative humidity 80% for
EC Representative with local electrical codes. For safe operation, temperatures up to 31°C decreasing
DongBang AcuPrime please pay attention to the alert boxes through- linearly to 50% relative humidity at 35°C.
1 forrest Units, Hennock Road East, out the manual. • Main power supply voltage fluctuations
Marsh Barton, not to exceed ±10% of the nominal
Exeter EX2 8RU, U.K voltage.

REF INC001 LTINC001_Rev.01(July 2016)

3. Components 5. Installation

5.1. Installation 5.2. Temperature

2 1
Incubator Power Cable User Manual

4. Specification
1) The incubator will begin its warm-up
Size (Width x 1) Plug the power supply into a power stage. The users can see the small
160 mm x 100 mm x 190 mm
Height x Depth) source. Insert the connector from the “on” under the temperature on the

Operating Range 58±2℃

power supply into the matching display.
receptical in the back of the incubator 2) When the temperature reaches 58℃,
Incubation Cavities 15 ea
2) Turn “On” the incubator. the incubator is ready to use. It may
Electrical 220 VAC / 50-60 Hz / 120 W take approximately 20 minutes for the
Weight 2 kg incubator to warm up to operating
temperature.
Quantity per Pack 1

REF INC001 LTINC001_Rev.01(July 2016)

6. Operation.

Biological Indicator Activation.

Prior to incubation, the biological indicator 1) Place the processed or positive

must be activated by crushing its internal control biological indicator into the
glass medium ampoule. It allows the color- left or right side of the crushing
change medium from the ampoule to cavity.
contact the spore carrier. 2) Flex the indicator to the opposite
side until the glass ampoule breaks.
3) Check whether internal glass
ampoule breaks.
4) Place the biological indicator inside
the incubating cavity and wait for
the appropriate length of time.
5) After the appropriate incubation
time, observe the color of the
growth medium in the BI.

REF INC001 LTINC001_Rev.01(July 2016)

 the sterility of their contents once sterilized.
Instruction For Use
ENVIRONMETN OF USE:
Instruction For Use LOWTEM Crystal Tyvek Pouch for low Hospital, Operating Room(OR), Physician and
temperature sterilization is intended to be used dental office or places where instruments and
LOWTEM Crystal Tyvek Pouch to enclose another medical device that is to be accessories are sterilized.
sterilized by a health provide and to maintain
sterility of the enclosed device until needed. Stored at low humidity ambient and at
temperatures below 30ºC. Also, a good stock
The sterilization pouch is intended for use with rotation is advised.
low temperature sterilization processes
LowTem Co., Ltd.
(hydrogen peroxide gas plasma/LOWTEM Crystal LOWTEM Crystal Tyvek Pouch is supplied in
#A-302, Gunpo IT Valley, 17,
sterilization system, peracetic acid gas plasma/ Reels : plain, several widths and two longitudinal
Gosanro 148beon-gil, Gunpo-si,
Plazlyte sterilization process or ethylene oxide) sealings. It lets user make bags as per requested
Gyeonggi-do, 435-833, KOREA
long.
Tel :+82(31) 427 0792
It is a peelable disposable pack, for packing and
Fax : +82(31) 427 0793
protecting clinical and surgical material to be
submitted to a Plasma sterilization process.
Manufacturer: KM Co., Ltd.
348-1 Boche, Miyang, Anseong, Single Use
LOWTEM Crystal Tyvek Pouch for low
Gyeonggi Korea, temperature sterilization is composed of a
porous, Tyvek backing to allow the sterilizing
EC Representative agent to penetrate into the package and a
DongBang AcuPrime polyolefin/polyester film as a front to allow
1 forrest Units, Hennock Road East, viewing of the pouch contents. These products
Marsh Barton, are intended for use with low temperature
Exeter EX2 8RU, U.K sterilization processes and are able to maintain

REF TPO001 LTTPOI001_Rev.01(July 2016)