Medical Sealing Machine Operation & Maintenance Manual(II)

 XI. Operation Qualification (0Q)

According to 5.7.10 Sealing and Packaging Requirements,Part II: Standard for Operating Procedures of Cleaning,Disinfection and Sterilization,WS310.2-2016

Central Sterile Supply Department (CSSD) and relevant regulations in GB/T19633.2-2015/ISO11607-2:2006, the accuracy of parameters and the sealing quality of the machine should be inspected before it works every day. Therefore,test cards and sealing strength testers should be used for OQ.

OQ refers to the sealing performance verification during the normal operation of the machine.

To test whether the sealing edge has any tube-like space or opening;

To test whether the pressure is too high or too low;

To test whether the sealing temperature is too high or too low;

To test whether sealing is continuous or the sealing edge has leaks;

It is suggested that users should finish the sealing test before and after daily sealing work,and the test sample should be stored for query.

To inspect and record operation qualification result and ensure the normal operation of the machine,it is recommended that our Easyseal reels, sealing test cards for paper-plastic pouches or Tyvek low-temperature sealing test cards should be used to inspect the sealing result under high and low temperature.

The sealing quality will be better guaranteed, if our Easyseal sealing strength tester is also used to inspect the sealing strength.

XII.Testing Method

1. Sealing Test Card:

Our Easyseal test cards can be used to validate whether the sealing result can meet the standards and serve as proof to record the performance parameters of the machine.

They can clearly show the sealing result and its defects. Therefore,sealing problems can be found out quickly and the sealing parameters can be adjusted accordingly to satisfy the sealing requirements and ensure the sealing quality. At the same time, test cards can be stored for validation or query for sealing results of the sealing machine.

There are two types of sealing test cards: high-temperature (180°C) paper-plastic pouch test cards and Tyvek low-temperature (120°C) sealing test cards.

2. Sealing Strength Tester

Our Easyseal Sealing Strength Testers (see Figure 8) are specially manufactured according to YY/T 0698.5-2009 standard,Packaging Materials for Terminal Sterilized Medical Devices-Part 5: Heat and Self-sealable Pouches and Reels of Paper and Plastic Film Construction-Requirements and Test Methods,to test whether the sealing strength of heat-sealed pouches and reels can meet the requirements.The tester can be connected with a computer (an option to be equipped with our sealing machine) and relevant parameters can be stored with special software to realize the query for previous sealing results.

Note: This test should be taken after the sterilization of pouches.

It is suggested that users should insist on routine inspection with test cards and sealing strength testers according to the requirements of WS310.2-2016 5.7.10 and ISO 11607.

By doing so, the sealing quality can be effectively guaranteed. Especially after the sealing material is changed or the machine is repaired, the use of test cards and sealing strength testers becomes more important and necessary.

If users cannot take such tests, please contact us for chargeable inspection service.

We can arrange people to take an on-site test for you or you can mail the sample or the machine to us for inspection and a relevant test report.

XIII.Equipment Maintenance

1.Fuse replacement

If the machine cannot operate normally after it is switched on, the fuse should be inspected for any damage. Before replacing the fuse, turn off the machine and disconnect the power line from the machine. Then pry the fuse base off and remove it from the side of the switch base with a slotted screwdriver.Replace the fuse if it is blown and re-fix the fuse base to the original place.

2. Stuck Pouch Removal

When a pouch is stuck in the machine and stops moving forward due to wrinkles or foreign matters, turn off the machine immediately and pull out the pouch slowly. Then,check whether the pouch is complete. If so, you can restart the machine but try to avoid the same accident.Fragments of pouches that fall into the machine or are stuck in the driving mechanism will affect the operation of the machine. At that time, you should ask a professional person to remove all the fragments and then restart the machine.

3. Replacement of Main control panel

After confirming the failure in the main control panel, turn off the power switch first, and disconnect the plug. Next,dismantle the cover of reel-feeding chamber. Then, dismantle the top cover of the machine and verify whether the specification of the new control panel is the same as that of the old one. At last, look over the appendix and wiring diagram to replace the main control panel. Please check the connection according to the diagram in case the machine cannot work as usual because of wrong wiring.

4. Machine cleaning

1) Turn off the machine and unplug it before cleaning its outside surface;

2) Clean the housing and the screen with a soft cloth and a mild cleaning agent, such as soap. Abrasive materials are forbidden (such as steel wool);

3)Don't insert any objects into thermovents and the reel-feeding hole of cutting mechanism to avoid electric shock or any damage to the machine when cleaning;

4)Don't make any water drop or tiny things enter the machine through thermovents,the reel-feeding hole of the cutting mechanism,when you clean the objects near the machine.Otherwise,failure in mechanical and electronic control system of the machine may happen.

XIV.Precautions

Do not open the machine housing in order to prevent

electric shock or scald. All the machine repairs and

upgrades must be done by people authorized by or trained by Yifeng Medical.

Please power off the device when it is in idle.

When fail happens,power off immediately; Troubleshoot before next use.

Seal operations of Tyvek bags (120°C low temperature bag) at high temperature（higher than 150°C) are strictly prohibited.

Forced startup with fail occurring is strictly prohibited;Machine can only be used after maintenance by specialist and authorized person.

Static cause great damage to mainboard; User must ensure a good grounding.

Avoid adhesive tapes in transmission mechanism and sticking on pressure wheels.

Conclusion:All the sealing device tests, seal strength tests and sealing regulations are to insure the content highly germ-free since sterilization, as well as to insure the machine working normally.

XV. After-sale service

1. Scope of free service:

promises 1 year after-sale service,from the date of the invoice (or one month after the date of production without invoice.offers free maintenance including renewal parts and device exchange in guarantee period (except power cable being vulnerable and color ribbon being expendable).

Contract provisions come first.

2. Scope of charged service:

1) charges for the service beyond the guarantee period.

2) In guarantee period, charges for maintenance if the cause is one of the

followings:

a) Body parts damaged by artificial force;

b) Dust accumulation, machine corrosion, moldiness, biological violation and inside liquid due to bad environment;

c)Melted materials attached to mechanical parts due to improper use;

d)Use of improper seal materials not mentioned in instructions;

e) No reliable ground connection;

f) Voltage used beyond rating;

g)Irresistible natural disasters;

h)Use of unoriginal parts;

i)Not following this manual;

j)Unauthorized modification, dismantle or maintenance;

k)Unable to prove the device is in guarantee period or the device is a product.

3. Maintenance procedure:

Maintenance from a licensed agent or requires following steps:

Caution: Users must provide the device number and service number to receive after-sale service.

1) Contact with sale department or authorized sale agent. Provide device number and service number at the right side of the product. will find the detailed production and maintenance file accordingly;

2) Provide certified acquisition date;

3) State the fails and faults;

4) Offer contact information;

5) If back-factory maintenance is necessary,please send the device by Debon or other manufacturer specific logistics to the manufacturer. Customer must afford the transport expense after warranty period expires.

4. Contacts:

If you have any problem, please don't hesitate to contact our company or sales agent.

Our contact information:

Company:

Address:

Tel.:

Tax:

E-mail:

Website:

Nationwide free service hotline:

Contact information of sales agent: (filled by agent or users)

Name:

Address:

Tel.:

Tax:

E-mail:

Website:

XVI. Intellectual Property

Our company is the copyright owner of this not open published service manual. Has the right to consider it restricted. This manual is only a reference to operate and maintain the product.

This manual and all intellectual property (including copyright) belong to our. It is forbidden for anyone unauthorized to use, disclose, or help others get information from this manual by any means. It is forbidden for anyone to take pictures, copy, duplicate and translate part of or all the information to any other languages without written authorization from our.

Our company owns the right of final explanation;

Our company keeps the right to modify the manual without prior notice.