HMTS-80E manual rapido

- Esterlizador de Plasma baixa temperatura

HUMANMEDITEK
Contents
HMTS 80E – Introdução

HMTS 80E – Guia de Operação

Monitoramento do processo de Esterilização

Manutenção

AVARIAS

Empacotamento e Carregamento
HMTS-80E Specification

Global Regulatory Approvals

from each countries

High Sterilization Efficacy

Proven by ISO 14937

Rapid and Safe Sterilization

Easy to Use / Install

Eco friendly – Non Toxic

HMTS-80E Specification
Total Volume 80 liter (2.83 cubic ft)
Usable Volume 71 liter (2.50 cubic ft)
Chamber Chamber shape Round
Ø dimension 400
Depth 650
Width (mm) 750 (29.1)
Height 1670 (69.5)
Sterilizer
Depth 835 (32.9)
Weight 430 Kg (947 lbs)
H2O2 Volume 80ml / bottle
Surface 　 25 (± 3 ) min 14 cycles
Cycle
Standard 　 38 (± 3 ) min 10 cycles
time
Advanced 　 53 (± 3 ) min 8 cycles
 HMTS-80E Component

Touch
Chamber screen

ON, OFF, HPS unit

CANCEL
switch

Drain Unit
Printer
HMTS-80E – Operation Guide
Devices Sterilized in the HTMS
• Heat and Moisture sensitive Metal & Non-metal Medical Instrument
• Medical devices with lumens and hinges difficult to sterilize with other methods of
sterilizations
• Validated efficacy with lumen Devices (Standard, Advanced Sterilization Process)

Materials Medical Equipment

•Aluminum
•Delrin acetal resin (polyacetal) •Rigid endoscope
•Ethylvinyl acetate (EVA)
•Video cameras and couplers
•Glass
•KRATON Polymers •Trocar sheaths
•Neoprene •Fiber optic light cables
•Nylon (polyamide)
•Polycarbonate
•Electro cautery instrument
•Polyethylene •Resectoscope/ working elements &
•Polyetherimide (ULTEM Polymers) sheaths
•Polymethyl methacrylate (PMMA)
•Metal instruments
•Polyphenylene sulfone
•Polypropylene •Endoscope instruments
•Polystyrene •Ultrasound probes
•Polyurethane
•Polyvinyl chloride (PVC)
•Patient lead cable
•Silicone elastomers •Dopplers
•Stainless steel
•Teflon
•Titanium
Non-compatible materials

Materials LUMENs

Flexible
• Materials absorb the sterilant Ø1x800, 10 pcs
• Wood, linen, paper, sponge, Ø1x1,600, 1pc*
gauge *No additional load
• Disposable medical devices Endoscope
• Wet materials Ø1x850, 2 pcs*
• Oil Two single-channel Teflon or
• Powder Polyethylene Flexible Endoscope can be
processed per cycle. No additional load.
• Liquid
Rigid
• Silk
Standard
• Towels Ø1x350, 10 pcs
*Ø0.77x500, 5pcs
*No additional load
 Sterilization Process

Wash, rinse, and dry with the way

Put CI Strip inside of Sealing temperature:
suitable for each device. pouch and put CI Tape
110~130℃
outside of t pouch
CI Tape

Load upto 80% Start

Loading DOOR Location of CI
strip &
of the chamber space sterilization
SCBI Process
Preparing Sterilization
Complete dry

• Error occurs with

moisture left within the instruments
• Dry inside of lumen / hinged part
with Air gun Lumen

Always main power switch ‘On’

Always have main power on to maintain inside

temperature(55±4℃)

Don PPE

Wear protective gloves and goggles when handling

sterilant
How to load items
▼ 올바른 예 ▼ 부적절한 예
Right Wrong

- Position pouch vertically to provide - Do not pack too many items in

optimum sterilant-penetration. Each one pouch.
pouch should not face vinyl to vinyl.
- Avoid stacking up.
- Allow space between pouches.
Dry items completely

Error – 16 can occur due to moisture left over on items

16

When sterilization cycle is aborted with error,

all of the items in the chamber should be repack and resterilized.

HOW TO START HMTS - 80E

1. Press “ON” button 2. Select “PROCESS”

3. Select Process 4. Select “START”

Wear Personal Protective Equipment when handling sterilants and drain bottle.
 Process Selection
SURFACE mode : 25 minutes STANDARD mode : 38 minutes ADVANCED mode : 53 minutes
Quick : Conventional : Versatile :
Surface Sterilization Cycle Flexible Lumen Sterilization Cycle with Extra Loads Flexible/Rigid Sterilization Cycle with Extra Loads HMTS-80E
• General metal/non-metal, non-lumened devices Ten(10) Polyethylene and Teflon lumen instruments with : Ten(10) Stainless steel lumen instruments with :
requiring surface sterilization, or sterilization of mated
• • Endo
internal diameter of 1 mm or larger and a length of 500 mm Internal diameter of 1 mm or larger and a length of 500
stainless steel or titanium surfaces or shorter mm or shorter
• Non lumen rigid, semi-rigid endoscopes • One(1) Long Polyethylene and Teflon lumen instruments • Five(5) Stainless steel lumen instruments with :
No. Of Cycle 15 Cycles
with: Internal diameter of 1mm or larger and a length of Internal diameter of 0.77 mm or larger and a length of
1600mm or shorter 500 mm or shorter H2O2 injection(ml 4.8 ml
Cycle Time(min) 38 min
Instruments that can be sterilized in the SURFACE mode Instruments that can be sterilized in the STANDARD mode Instruments that can be sterilized in the ADVANCED mode
include but not limited to; include but not limited to; include but not limited to;
• General medical devices without lumen • General medical devices with lumen • General medical devices with rigid lumen
• Flexible, rigid and semi-rigid endoscopes • Flexible scopes • Rigid Laparoscope
without lumen • Sterilization containers • Rigid endoscopes
• ENT scopes • Cameras and light cords • Rigid Laryngoscope
• Telescopes • Suction cannulas • Rigid Telescope
• Scissors, Forceps • Electronic / Fiber optic cables • Optic Rigid endoscope
• rechargeable batteries • Ultrasonic handpieces • Laparoscopic instrument sets
• Devices listed on SURFACE mode • Devices listed on SURFACE & STANDARD modes

Additional
information for
Endo
Mode Cycle are
needed
Loading Instruction Loading Instruction Loading Instruction
One shelf of the chamber (bottom shelf) can be used in Two shelves of the chamber may be used in STANDARD mode. Two shelves of the chamber may be used in ADVANCED
SURFACE mode. Max. loading weight: 8.9kg (19.6lbs) mode.
Max. loading weight: 4.45kg (9.8lbs) Max. loading weight: 8.9kg (19.6lbs)

No.of cycle/H2O2 bottle No.of cycle/H2O2 bottle No.of cycle/H2O2 bottle

14 cycles 10 cycles 8 cycles
Select Process

Surface Standard Advanced Endo

25 ±3 min 38 ±3 min 53 ±3 min 38 ±3 min

•12 cycles per bottle •7 cycles per bottle •6 cycles per bottle •12 cycles per bottle

•Medical device •Medical device with •Medical device with •Endoscopes with
without lumen lumen longer lumens accessories Only
(up to two sets)
•Ex) scissors, •Ex) short tubes, •Ex) longer tubes,
forceps endoscopes endoscopes
 HOW TO CHANGE THE STERILANT
Caution! Wear Protective gloves /goggles !!

1. Select “MODE” 2. Open the side door 3. Remove the lid 4. Insert a new bottle 5. Close door
and remove the aligning red point on
used bottle the bottle with red
point on the machine.

72

5. Close the HPS door 6. Select “SET”, put 7. Select “SCAN” 8. The puncture plate
and select “SETUP” “1212” and “ENT” automatically comes
down

The images are subject to change without prior notice.

 HOW TO DRAIN HMTS - 80E

1. Press “ON” button 2. Select “MODE” 3. Select “SETUP”

4. Insert password “1212” 5. Select “DRAIN” 6. Select “YES”

& select “ENTER”
 HANDLING DRAIN REPLACEMENT OF
BOTTLE PRINTER PAPER

1. If the bottle is filled to the red line,

empty the bottle
Put the new roll in,
2. Fill the bottle with 100ml
then pull out the paper through the slot
of water to the tip of the
arrow mark
Direction of the paper

3. Arrow marks on the bottle

must be aligned with the
mark on the machine
Wear Personal Protective Equipment
 HOW TO CANCEL CYCLE HMTS - 80E

1. Press “CANCEL” button 2. Select “CLOSE” 3. Check the process

After “Plasma 2 & Air/vent” stage is completed, the door will be

opened.
It takes about 8 minutes.
After finishing the cycle, the item must be re-packed and
re-sterilized.
H2O2 Sterilant Handling Procedure

 Wear protective gloves and

goggles when changing sterilant.

 Due to high acidity direct contact with liquid hydrogen peroxide can irritate skin
and eyes

 Flush with lots of water at least for 15 minutes.

Rinse/wash eyes with water immediately and see a doctor.

 Store in refrigerator at temperature (2~8℃) or in room temperature avoid heat

and inflammables.
Sterilization Monitoring
PROCESS BI MONITORING

1.Prepare SCBI 2. Insert SCBI with 3. After process,

* Do not Crush! CI strip into crush white label
HMTS-pouch with ampule crusher

Front Door Rear

Injection Port Injection Port

Position : SCBI
PROCESS BI MONITORING

Incubate
for 24hrs
at 58~62℃

4. Check the disc 5. Incubate processed and

if it is absorbed by unprocessed SCBIs for 24hrs
purple medium
6. After 24hrs incubation,
check the vials for results

- Negative SCBI
Purple
(No growth) - Sterilization was
successful!
- Positive SCBI
- Repeat test with another SCBI
Yellow - If positive again,
(Spore growth) call an engineer to check machine
- Sterilize yellow SCBI in autoclave
sterilizer before disposal
Control BI Monitoring

1.Prepare 2. Crush white label 3. Check the disc 4. Incubate processed and
control SCBI with ampule crusher if it is absorbed by unprocessed SCBIs for
* Do not process! purple medium 24hrs

5. After 24hrs incubation, check the

vials for results
- Positive SCBI
Yellow
(Spore growth) - Sterilize yellow SCBI in autoclave
sterilizer before disposal

Purple
(No growth) - Negative SCBI
- SCBI must be checked
Monitoring sterility –
How to read CI strip
Color on the strip is changed upon chemical reaction when
exposed to hydrogen peroxide

1. The color within red-dotted line will be accepted as being

sterlized correctly.
2. Other colors of CI will be reject. Items should be re-sterilized.
Monitoring sterility – CI Tape

Before process : Red

After process : Yellow

Monitoring– Screen and paper

PASS

 Screen shows
sterilization stage,
time, pressure,
temperature.
Maintenance
SELF TEST HMTS - 80E

1. Select “MODE” 2. Select “SELF TEST”

4. Wait for a while and check 5. If you need to print out

3. Select “Integrated the summary of test result. the result, select “PRINT”
Self-Test” VALVE: 30sec, PLASMA: 3min
PRESSURE: 10min
 How to clean the chamber

1. Remove the bottom tray from the

sterilization chamber.

2. Wet gauze with distilled water..

3. Clean the chamber with wet gauze until

white residue is invisible.

Caution!
 Do not pour liquid inside the chamber.
Do not use rough cloth. It can damage silicon ring inside
of the door.
Do not wipe the injection hole.

Cleaning : gauge, distilled water, gloves.

Consumable Shelf Life
Sterilant
Controlled (2~8℃) Environment -18months
Room Temperature - 12 months SCBI
After Inserting Into HPS Unit - 1 month 24 months

CI Tape
3 Years Pouch
5 years

CI Strip
2 years
Trouble shootings
Trouble shooting
When you can not open door
1. Check power outage or switch button
2. Restart process (AUTO > START)
Once restarted then push CANCEL button
wait until process is over (It takes about 8min. )
※ Please see “Cancel” page

When error occurs

1. Not to switch off
2. Wait for at least 8 minutes until sterilant safely decomposed to
water and oxygen. Stage automatically jumps to Plasma II when
error occurs.
ERROR 16 (vacuum error)
Possible causes

Load less than 80% of chamber

Items overloaded or stacked Items should have spaces in
between to make sure all
sides are exposed to sterilant

Complete packing before Packing

Moisture left on items

Materials Check materials for compatibility

- Too many silicone items Divide silicone items to several
- Items not compatible cycles
 ERROR 16 (Vacuum error)
Possible causes
• Moisture

• Over loading

• Leakage inside of sterilizer

• Not compatible items or too much silicones

( If silicone items are more than 3 since silicone is microporous.)
Packing and loading
 Instrument Packing

Instruments can be packaged for sterilization

utilizing different methods.

HMTS-Chemical Indicator Strip should be placed

inside each pouch and container or tray to provide
confirmation that the instrument has ben
processed.

HMTS-Pouch or CI-pouch are made of Tyvek®, which

is permeable to hydrogen peroxide vapor and
provides a microbial barrier.
How to use HMTS-Container

Should Place items with CI strip in a container

Then, Pack with a pouch or non-woven sheet
Stick CI tape on the vinyl part of pouch & non-woven
sheet

CI tape
Instrument Packaging

Single instruments may

be placed in TYVEK
pouches, enabling
easy identification of
the contents.

HMTS chemical
indicator strip should
be placed in the each
pouch.
Application of Chemical Indicators

Several Packing methods

Wrapping with Non-woven sheet

Put CI Strip & stick CI tape on the non-woven

sheet

Non-woven sheet

Packing in the pouch or CI pouch

Put CI Strip & stick CI tape on the

pouch

Packing in the Container

You should put CI Strip in a
container,

then pack with a pouch or non-woven

sheet
Instrument Preparation

Once instruments are

cleaned, dried, and
inspected, those should
be arranged in instrument
trays/baskets. All hinged
instruments should be
opened, items with
removable parts should
be disassembled unless
the device manufacturer
or researchers provide
specific instructions or test
data to the contrary.
HMTS Chemical indicator
strip should be placed in
the each container prior to
wrapping.
 Benefit from Using Container

Safe for instruments with or without silicone mat .

Safe for high-priced instruments such as endoscopes.
Easy to keep a complete “Instrument set” (refer to
second photo.)
 How to use Pouch

CI tape
Sealing with HMTS –
CI strip
rotary sealer

Place item with CI strip in the pouch or with CI pouch

Stick CI tape on the vinyl part of pouch after sealing.
When you use CI pouch, no need to stick CI tape on the pouch.
Instrument Packaging

There are several choices in

methods to maintain sterility of
surgical instruments including
rigid containers, peel-open
pouches and sterilization wraps.
The packaging material must
allow penetration of the sterilant,
provide protection against
contact contamination during
handling, provide an effective
barrier to microbial penetration.
Double wrapping can be done.
The sequential wrap uses two
sheets of the standard
sterilization wrap, one wrapped
after the other.
 Benefit for pouching

Transparent PE part of pouch allows easy instrument identification.

Easy visual check for color change of CI strips .
Useful for packing each single instrument like above.
Easy to peel and open in an OR field.
SAMPLES FOR ITEM PACKING 1-1

Light Cable (O) Light Cable (O)

Harmonic ACE line (O) Telescope (O)

SAMPLES FOR ITEM PACKING 1-2

Tubes & HF cable (O)

Forceps (O) Forceps (O)

SAMPLES FOR ITEM PACKING 1-3

Mouth piece (O) Cable (O)

Camera head (O) Tibial preparation set (O)

 SAMPLES FOR ITEM PACKING 1-5

Dry completely
with the air gun !!
Tubes with moisture inside
(X)

Silicon mats in the

containers can cause
Silicon mat
improper chemical
indicator color change !
SAMPLES FOR ITEM PACKING 1-6

This silicon tube can abort

the cycle. The number of
silicon tube should be less
than 3 per cycle.

Do not load bundles of plastic

covers(vinyl) ! (Vaporized
hydrogen peroxide can not
penetrate the plastics when
they are folded).
SAMPLES FOR ITEM PACKING 1-7

Do not pack
many items
in a pouch
• Flexible scopes • Rigid Laparoscope
• Sterilization containers • Rigid endoscopes
•• Cameras and light cords • Rigid Laryngoscope
•
•
Suction cannulas
Electronic / Fiber optic cables
Loading
•
•
Rigid Telescope
Optic Rigid endoscope
•• Ultrasonic handpieces • Laparoscopic instrument sets
•

All items to be sterilized

should be arranged so
• General medical devices with rigid lumen
• Rigid Laparoscope that all surfaces will be
• Rigid endoscopes directly exposed to
• Rigid Laryngoscope
• Rigid Telescope sterilizing agent.
• Optic Rigid endoscope
• Laparoscopic instrument sets
Small items should be
loosely placed in wire
baskets and peel
pouches should be
placed that the clear
side of one pouch
faces the TYVEK side
of the next pouch.
Loading

Do not stack
instrument trays on
the top of the others.

Do not load too many

items in the sterilizer
so that items can be
exposed to sterilant.
CONTACT POINT

Web site : www.hmmdt.com

E-mail : hmcs@hmmdt.com

Phone : +82-2-6292-2682
Fax : +82-2-868-1555