I. About
Thank you for choosing KM100 series of sealing machine. To maximize its performance,please carefully read this manual and install and operate it by strictly following this manual to ensure its safety and reliability in use. We recommend placing the manual in an accessible place for better reference during the operation.
II. Applied Area
Automatic medical sealing machine, 100-L series, is capable of continuous paper-plastic bag, 3D paper-plastic bag and paper-paper bag sealing. The sealing process satisfies the requirements of high-temperature steam sterilization, low-temperature ethylene oxide sterilization, hydrogen peroxide plasma sterilization and radiation sterilization. Seal quality meets corresponding international standards and GMP recognition.
Sealable materials:
Compliance with EN868-5 and YY/T 0698-5 bags and volumes;
Compliance with EN868-4 and YY/T0698-4 paper bags;
High density polyethylene materials (such as Tyvek);
Aluminum foiled materials.
Non-sealable materials:
Polyethylene film;
Soft and hard film;
Nylon membrane;
OPP film.
III. Features
See the main machine composition in Figure 1.
Main Features:
Automatic micro-computer temperature control, easy operation, large-screen display, high reliability and continuous sealing; The machine complies with WS310.2-2016 Central Sterile Supply Department(CSSD)
Part II: Standard for Operating Procedures of Cleaning, Disinfection and Sterilization,GB/T19633.2-2015/ISO 11607-2-2006,EN868-5-2009 and YY/T 0698-2009.
It has passed the ISO9001 certification and CE certification including 2006/42/EC（Machinery Command),2006/95/EC (Electric Command) and 2004/108/EC (EMC Directive).
This machine is not listed in Class I, II and III medical instruments regulated by Regulation on the Supervision and Administration of Medical Devices (Order of the State Council of the People's Republic of China No. 276), so it will not be managed as a medical instrument.
IV. Technical Parameters
Seal speed:10m/min;
Seal margin: 0-35mm adjustable;
Seal width:12mm;
Work temperature:60-220°C;
Temperature precision:≤1%;
AC power:220 50Hz
Power:500W;
Max current:3.2A;
Fuse:5Ax2;
Dimension:482x242x157mm(LxWxH)(without support and guide plate);
Weight:11kg;
Sealing orientation: from left;
Storage:
Temperature:10-40°℃;
Humidity:≤90%(R.H);
Atmospheric pressure:50-106kPa.
V. Safety
1. The device is strictly tested before leaving the fctory to ensure each one is both reliably qualified and safe.
2. Safety instruction, nameplates and labels of the product must remain complete during installation and usage.
3. Please make sure that the device is complete before use. If it has any damage, please contact the manufacturer or authorized agents. Flawed devices are strictly forbidden to continue the installation and usage.
4. Before switching on it, please make sure there is no unsafe signs shown in the device. If you have any questions, please contact the manufacturer or authorized agents.
5. Do not use the device with the power cord, plug or device itself damaged. If the power cord or the device has been damaged, it must be repaired by the manufacturer or an authorized agent before use.
6. The device's matched power cord must be the original one provided by the manufacturer and be connected to a reliable grounded outlet with a secure stable voltage.
7. As the device contains high temperature and high pressure components, its installation and operation in places with explosion hazards are forbidden.
8. The device must be moved between the two places with equal temperature to prevent dew condensation, or the power source can be connected only when dew evaporates.Forced power connection will cause electric shock and damage to the device.
9. Please power off or disconnect the plug when the device is idle.
10. Be sure to cut off the power before cleaning! Only dry or slightly moistened soft cloth and neutral cleaning agent are permitted for cleaning.
Danger: Never allow any wet stuff to touch the device!
11. No sharp or flat hard objects can be sent through the cutting and reel-feeding hole so as to avoid any harm to the device.
12. It is forbidden to insert any objects into the thermovent to avoid electric shock or any damage to the device.
13.If the device is found unsafe, please stop using it immediately.
14. The users must reach 18 years old.
VI. Main Characteristics
1. Two-line high-light LED display, touchable keyboard, temperature setting and display.
2.Temperature controlled by a microcomputer, accuracy±1%,working temperature range of 60~220°C;
3. High-speed increase of temperature: only 60 seconds required from 20°Cto 180℃ and only 10 seconds required to increase the normal working temperature from 120°Cto 180°C. Highly efficient and energy saving;
4. Safe operation: If the sealing temperature is out of setting more than ±4°C,the machine will automatically stop working, which effectively guarantees the seal quality and safety.
5. Sealing speed: 10m/min; automatic sealing test using light-control technique;
6. Sealing width:12mm;Sealing indexes meet standards WS310.2-2016 and YY/T0698.5-2009;
7. Seal margin: 0~35mm adjustable;
8.With adjustable fixed-force system,the machine can seal 3D pouches and other paper pouches with different thickness by automatically adjusting sealing pressure;
9. Automatic failure warning and automatic detection during working;
10. Advanced flat ceramic heating components feature quick increase of temperature, well-distributed heating, high-temperature resistance, long service life and high heat efficiency;
11. The machine is fitted with complete components such as the cutting machine, ultra silent roller worktable, multipurpose workstation of the sealing device, and other peripheral accessories to improve its utilization rate and bring convenience to users.
VII. Installation
1. Check the completeness of the packing box. If there is obvious deformation or mechanical damage,please contact our company or agents promptly to figure out the reason and responsibility.
2. After the packaging box is opened, carefully remove the machine and the
accessories from the box. Check the device and the accessories according to
the appendix I,the packing list.Record the missing parts if necessary.
3. Please preserve the packing box, attaching files and other accessories
properly for future use.
4. At least 5cm-long room around the device is left for the flow of air during the installation. Avoid vibration, dust, corrosive or explosive gases, extreme temperature and humidity, etc.
5. The machine requires a flat and stable worktable (multipurpose worktable
designed by Yifeng Medical is highly recommended).
6. Guide plate installation:First,screw off the left-side nut of the device anticlockwise and take down the gaskets. Second, place the guide plate and put gaskets on it with nuts tightened clockwise.
7. Support Installation: Lift the machine,screw 2 supporting legs in the bag inside the 2 M6 hole on the bottom of the machine and make a 15° angel between the machine and table for better use.
8. Power connection:
Make sure that the AC power supply should be 220V, 50Hz;
Insert one end of the power cord matching the machine into the its power
interface, and plug the other end into a 3-pin power socket which has been
properly grounded.
Warning: The power socket must be properly grounded!!
VIII. Installation Qualification (IQ)
According to the requirements of GB/T19633.2-2015/ISO11607-2:2006 for sealing quality,we should use test cards to perform the installation identification (IQ).
Installation test means that the machine has to take a validation of performance before it is put into use.
The sealing quality is related to the sealing temperature,pressure and speed. All these parameters should be adjusted in view of reels produced by different companies so as to reach certain sealing quality.
The parameters of the machine,such as sealing temperature and pressure, can be noticeably shown on the testing area of test cards.
Note:For a better examination and record for the installation identification result, our Easyseal test cards are highly recommended
According to ISO11607-2,the sealing strip has to meet the following requirements:
Continuous and complete.
Sealing width≥6mm.
No channel or unsealing area.
No perforation or torn parts.
No material layering or separation.
After the detection of low temperature and high temperature test cards, it is necessary to use the sealing strength tester to test sealing strength. The test will determine whether the sealing strength can meet the requirements before and after the sterilization process.
X. Seal Operations
1. According to WS310.1-2016(9.8:Packaging Material,Part I:Management Code
of Central Sterile Supply Department (CSSD)) and Chapter II Sealable Materials of this manual, users should choose suitable paper-plastic or paper-paper packaging reels.
In addition, users need to check the sealing strength of both sides of a reel before use.
2. Adjustment of the Guide Plate: Located at the left side of the machine,the guide plate can be moved within a range of 0~35mm.Counterclockwise loosen the nut until the guide plate can be moved back and forth. To move the guide plate outward will make the sealing line close to the edge of the pouch; while to move it inward will make the sealing line away from the edge of the pouch (see Figure 2). After the adjustment is completed, clockwise turn the nut until the guide plate is firmly fixed.
3. According to the size of the medical instrument to be packaged, select suitable sterilization reels. Put medical instruments in pouches and seal the other side with the machine.In accordance with the relevant provisions of WS310.2-2016, the distance between the sealing line and the
instrument inside the pouch should be more than 2.5cm, which has to be considered when setting up the cutting length.
4.When placing medical instruments into pouches, please pay attention to the following items: a. Properly put specially-shaped and sharp items in pouches and use protective sheaths for them if it's necessary; b. Medical
instruments should be placed into pouches with proper sizes to avoid over-pressure, and their volume should not exceed 75% volume of pouches to prevent any breakage during sterilization and ensure their safety in use.
5. After a medical instrument is put into a pouch, make the pouch be fed into the machine along the guide plate at the left side of the machine with the paper surface downward.Then the driving mechanism will start working automatically.
6. How to make sure the sealing edge is straight, smooth and parallel with the edge of the pouch, when no roller worktable is equipped: Hold each end of a pouch with your hands, and flatten the section of the pouch to be fed into the sealer; Prior to sealing, the opening (edge) of the pouch should be parallel with the machine; The pouch should be supported by your hand to ensure right movement direction, after the driving mechanism is switched on. With the pouch completely fed into the machine, the operator should hold the medical instrument inside the pouch until the sealing work is over.
Note:For higher sealing efficiency, please choose the ultra silent roller worktable or multipurpose sealing workstation.
7. To improve efficiency,preparation is needed. Make sure paper plastic pouch should be fed into the machine parallel to it.
8. Remove all the sealed pouches after sealing and let them cool down naturally.
Suggestion: Because the material used by paper-plastic pouch (paper-paper pouch) manufacturers are different , test cards or test pouches should be used to test thesealing effect and the dedicated tester should be used to verify the sealing strength.In addition,suitable sealing temperature should be confirmed to ensure sealing quality. Sealing temperatures differ because of different types and thickness of materials used to produce pouches.
To ensure better sealing result, please choose the pouches which are in
accordance with the National standards (It is suggested that you purchase Easyseal reels and high/low-temperature sealing test cards or pouches.)
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