|
Model
|
MZS -12 |
|
Product name
|
Helix test |
|
Process
? Types of sterilization, control of the intended sterilization method |
Steam |
|
Indicator Shape
|
Strip, Hollow tube |
|
Country of Origin
|
China |
|
OEM
|
available |
|
Functions
|
control sterilization quality |
|
Properties
|
Sterilization acessories |
|
Material
|
PTFE |
|
Applicable methods sterilization
|
STEAM, ETO gas |
|
Indicator Color Change
|
yellow to blue, yellow to black |
|
Quantity in box
|
1 set |
|
Quantity in carton
|
100 sets |
|
Packing way
|
1 platic helix test device and 200 helix strips |
|
Length, mm
|
1500 |
|
Quality Certification
|
CE, ISO 13485 |
MEDIWISH® Helix Test System. Hollow Load PCD.REF
Directions for Use. INDICATIONS FOR USE
PACKAGING
The Mediwish Helix Test can be reused for 200 cycles and consists of one Mediwish Helix Test PCD device 200 Mediwish Helix Test strip monitors. Indicator Strip is self-adhesive for easy documentation.
DESCRIPTION
The disassembled Mediwish Helix Test Process Challenge Device consists of the following parts: a standardized lumen connected to an end-cap, an indicator capsule with sealing “O' ring, Class 2 ink chemistry Conforms to ISO 11140-1, Class 2.INSTRUCTIONS FOR USE
Unscrew the indicator capsule from the lumen end cap.
Remove a Mediwish Helix Test indicator from the protective pouch and fold it in half at the score line with the indicator ink facing inward.
Insert it into the indicator capsule with the fold first.
Replace the indicator capsule by twisting by hand until snug. NOTE: DO NOT over tighten the cap using tools.
Place the assembled Mediwish Helix Test device in the sterilizer, in a horizontal position, near the coolest location in the sterilizer (usually on a shelf, near the drain, next to the door).
Conduct the intended sterilizer cycle.
At the end of the cycle, remove the Mediwish Helix Test PCD from the sterilizer and wait one minute to allow the device to cool before opening. CAUTION: The Mediwish Helix Test device may still be hot. Use hand protection if necessary.
Open the indicator capsule and remove the Mediwish Helix Test monitor strip. Read the results.
Document the results as required by hospital procedures.
10. Allow the device to cool and dry prior to next use. Look for one or more slugs of water that could block the free transmission of air or steam throughout the entire length of the lumen. Do not use if water slugs are present. Placing the open device in a warm dry place can accelerate drying.
11. The indicator strip has a self-adhesive backing and can be applied to the sterilization records.
INTERPRETATION OF RESULTS
Color change from Pink to Black indicates satisfactory air removal and steam penetration within the load. The presence of any pink color remaining indicates insufficient sterilization conditions and re-sterilization is recommended. Follow hospital procedures for re-sterilization of the load.
REMOVING THE RELEASE LINER
Remove release liner by bending the folded monitor back on itself, which will cause the release liner to pull away from the monitor slightly at the fold line. Grasp the release liner and pull to remove. Adhere individual monitors to records as specified by hospital policy.
STORAGE
Store at room temperature 10°- 40°C. Do not remove Mediwish Helix Test monitors from protective foil pouch until ready for processing. Protect from moisture and excess humidity by resealing the foil bag after each use. Once processed, the monitor strips are stable and require no special storage conditions.
EXPIRY DATE
The expiry date is printed on the product packaging.
LOT NUMBER
A unique identification code, |LOT], is printed on each indicator and packaging labels.
INTERFERING SUBSTANCES OR CONDITIONS
There are NO KNOWN INTERFERING SUBSTANCES OR CONDITIONS that could affect the intended use of the indicator or adversely affect the indicator performance.
RELEASE OF TOXIC SUBSTANCES
The indicator releases NO KNOWN TOXIC SUBSTANCES in sufficient quantities to cause either a health hazard, or a hazard to the intended properties of the product being sterilized before, during or after the sterilization process.
| Ordering Information | |
| Art No. | Qty. |
| MZS -12 | 1 device + 200 indicators |
Mediwish is a reliable and experienced contract manufacturer of hospital sterilization pouches and reels for B2B international customers. Here are some reasons why you should choose Mediwish:
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High-quality materials: Mediwish uses only medical-grade paper and plastic materials, such as polypropylene and polyester, in the production of hospital sterilization pouches and reels. These materials are safe and able to withstand the sterilization processes without compromising the integrity of the product.
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Expertise in sterilization methods: Mediwish has the necessary expertise and equipment to perform different sterilization methods, including steam sterilization, ethylene oxide gas sterilization, and gamma irradiation. This ensures that the products are properly sterilized and safe for use in medical settings.
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Compliance with regulations and standards: Mediwish complies with various regulations and standards, including ISO 13485, FDA 510(k) clearance, and CE marking. This ensures that the products meet the necessary quality and safety requirements.
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Flexible packaging and labeling options: Mediwish offers flexible packaging and labeling options to meet the specific requirements of its customers. This includes clear identification of contents, expiration or sterilization dates, lot or batch numbers, sterilization methods used, and manufacturer information.
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Competitive pricing and payment terms: Mediwish offers competitive pricing and flexible payment terms to its customers, ensuring that they receive the best value for their money.
In summary, Mediwish is a trusted partner for contract manufacturing of hospital sterilization pouches and reels for B2B international customers. With its focus on high-quality materials, expertise in sterilization methods, compliance with regulations and standards, flexible packaging and labeling options, and competitive pricing and payment terms, Mediwish is an ideal choice for medical device companies looking for a reliable and experienced partner.
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