SKU 239761
Mediwish Helix Test Hollow Load Process Challenge Device (PCD) with autoclave test strips is compliant with EN 867-5 for pre-vacuum steam sterilization of hollow loads. Mediwish Helix Test hollow load PCD verifies air removal, deep vacuum achievement necessary for lumens, steam penetration, and exposure levels. It is a reusable device that can be utilized in each sterilization load, as an independent control device for decisions regarding load release or for daily release of pre-vacuum steam sterilizers should hollow load tests be required.
Details Characteristics
Model
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MZS -12
Product name
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Helix test
Process
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Steam
Indicator Shape
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Strip, Hollow tube
Indicator Type
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Type 2 Chemical Indicator
Country of Origin
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China
USD $10 /set
USD $15.00 /set
Safe USD $ 5.00 /set
Indicated price applies exclusively to online purchases and may vary from prices offered by company to wholesale buyers.
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5 000+ goodsIn our online store. Ready to delivery from our warehouse
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Delivery on timePrompt delivery and unloading
Model
MZS -12
Product name
Helix test
Process
?
Types of sterilization, control of the intended sterilization method
Steam
Indicator Shape
Strip, Hollow tube
Indicator Type
?
Types (Classes) of indicators for sterilization
Type 2 Chemical Indicator
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 autoclave test strips
Length, mm
1500
Quality Certification
CE, ISO 13485
MEDIWISH® Helix Test System. Hollow Load PCD.REF
Directions for Use. INDICATIONS FOR USE
CRITICAL PARAMETERS (in a standard hospital steam sterilizer):
3.5 minutes at 134°C; 15 minutes at 121°C STEAM process. 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 bags 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 |
Why Choose Mediwish?
Why Partner with Mediwish for Your Sterilization Needs?
At Mediwish, we understand the critical role sterilization pouches and reels play in ensuring patient safety. That's why we go above and beyond to be your trusted partner in every step of the process. Here's how we can benefit your business:
- Unmatched Quality: We use only medical-grade materials, ensuring your pouches and reels withstand rigorous sterilization processes without compromising integrity.
- Expert Sterilization Solutions: Our team has in-depth knowledge of various sterilization methods like steam, ethylene oxide gas, and gamma irradiation. We ensure your products meet the highest safety standards.
- Confidence in Compliance: We strictly adhere to regulations like ISO 13485, FDA 510(k) clearance, and CE marking. This gives you peace of mind knowing your products meet all quality and safety requirements.
- Flexibility at Your Fingertips: We offer a wide range of packaging and labeling options to meet your specific needs. This includes clear identification for easy tracking and efficient workflows in your healthcare facility.
- Competitive Advantage: We pride ourselves on offering competitive pricing and flexible payment terms. Partner with us and get the best value for your investment.
In short, Mediwish is more than just a manufacturer. We're your partner in ensuring the sterilized products you use reach your patients safely and effectively.
How about payment terms?
For new client: 50% T/T, balance paid before shipment.
Old clients with very good credit would enjoy better payment terms!
Old clients with very good credit would enjoy better payment terms!
Could I have my own brand / my private label?
Absolutely! Mediwish Co., Ltd. can help you create your own brand or private label products. We have experience working with clients to develop custom medical equipment solutions that meet their specific needs and branding requirements.
Here's a breakdown of how we can assist you:
- Product Development: We can work with you to design and develop a product that aligns with your brand vision. This may involve customizing existing products in our range or creating something entirely new.
- Private Labeling: Once the product is finalized, we can integrate your brand elements (logo, colors, etc.) into the design and packaging. This allows you to present the product as your own private label.
- Minimum Order Quantities (MOQs): There will be minimum order quantities (MOQs) to consider for private label production. These vary depending on the product complexity and customization level.
- Regulatory Considerations: We'll ensure all necessary regulatory requirements are met for your private label product.
To get started, we recommend:
- Contacting our sales team: Discussing your specific needs and brand vision will help us determine the best approach for your private label project.
- Visiting our website: You can find more information about our custom manufacturing capabilities on our website.
We're excited about the possibility of partnering with you to bring your private label brand to life!
Can I get free samples?
Yes, you can get free samples in some cases!
We understand wanting to try a product before you buy it. Here are the ways you can get samples from Mediwish:
- Free Pre-Production Samples for Custom Orders: If you're interested in a custom product, we can provide a sample of a similar design free of charge. You'll just need to cover the express shipping cost.
- Standard Products (Fee with Credit towards Purchase): We offer samples of most standard products for a fee (catalogue price + express shipping). This fee is then credited towards your order if you decide to purchase the product.
In addition to the free and fee-based options above, you can also:
- Visit our showroom to see and feel standard products in person. Our friendly staff is happy to answer any questions you have.
For more details and information on other sample request scenarios, please refer to our full Sample Policy:
Photo gallery
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Articles
Hospital Sterilization
25 June 2020
Medical devices that penetrate during manipulations into the normally sterile tissues of the patient's body, in contact with blood and injectable drugs, are referred to as the so-called "critical", representing a high risk of infection of the patient in case of microbial contamination of these products. Given the available data on outbreaks of infections associated with inadequate reprocessing of devices used in surgical practice, an important role is given to the sterilization of devices, in particular, surgical instruments.
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