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
Process
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Steam
Chemical Indicator Type
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Type 2
Indicator Type
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Type 2 Chemical Indicator
Material
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PTFE
Product Form
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Hollow Tube / Helix Device, Strip
Model
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MZS -12
Please include in your request: product name or model, dimensions and specifications, quantity and destination country. For OEM or private-label projects, add your packaging and labeling requirements.
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Delivery on timePrompt delivery and unloading
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
The standard steam version changes from yellow to black. Other colour-change versions are available on request. A separate complete ethylene oxide (EO) system for MZS-12 is also available on request. Interpret results according to the instructions for the selected system and its matching indicator strips.
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 |
Process
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Types of sterilization, control of the intended sterilization method
Steam
Chemical Indicator Type
Type 2
Indicator Type
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Types (Classes) of indicators for sterilization
Type 2 Chemical Indicator
Material
PTFE
Product Form
Hollow Tube / Helix Device, Strip
Model
MZS -12
Product name
Helix test
Indicator Shape
Strip, Hollow tube
OEM
available
Functions
control sterilization quality
Properties
Sterilization acessories
Material
PTFE
Applicable methods sterilization
Steam (standard); separate complete ethylene oxide (EO) Helix system available on request. Use matching indicator strips.
Length, mm
1500
Indicator Color Change
Standard steam: yellow → black; other color-change variants available on request. Follow the supplied strip instructions.
Quantity in box
1 set
Quantity in carton
100 sets
Packing way
1 platic helix test device and 200 autoclave test strips
Quality Certification
CE, ISO 13485
Country Of Origin
China
Indicator Change
Standard steam: yellow → black; other color-change variants available on request. Follow the supplied strip instructions.
Material Specification
PTFE
Model
MZS-12
Oem Available
Yes
Packaging
1 platic helix test device and 200 autoclave test strips, 1 set, 100 sets
How can I find the right products for my distribution or procurement project?
Mediwish works with business buyers on wholesale and OEM projects. Send the product family, intended application, required sizes or formats, expected quantities and destination market. Use the product-specific quotation and documents to confirm the exact configuration before ordering.
How are payment terms agreed?
Payment method, currency, payment schedule and any bank charges are stated in the written quotation or order confirmation. Confirm these terms before accepting an order; do not rely on payment percentages shown in an older FAQ.
Can we use a private label or the Mediwish brand?
Tell us the selected products and whether you need private label or Mediwish branding. Availability, artwork, labeling, documents and commercial arrangements are confirmed for the product and destination market. Branding alone does not establish permission to market a product.
Can I request samples, and how are sample and shipping costs agreed?
Send the product or model, specification, quantity and delivery address. Availability, sample charges, delivery costs and timing are confirmed in writing before dispatch. Free samples or a credit against a later order should be assumed only when expressly agreed.
Send your request with the product name or model, required specifications, quantity and destination country. Product configuration and payment and delivery terms are agreed when the order is confirmed.
Photo gallery
5 photo —
Articles
Hospital Sterilization
25 June 2020
Medical devices that penetrate during manipulations into the normally sterile tissues of the patient's body, or enter the vascular system or carry sterile body fluids, 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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