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Reprocessed by
Instructions for Use
Reprocessed MyoSure XL Tissue Removal Device
Reprocessed Device for Single Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
• STERILE
• Exposed to Ethylene Oxide (EO) gas
Explanation of Symbols
Symbol
Standard
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
ISO 15223-
1:2016
BS EN
15986:2011
Stryker Sustainability Solutions, Inc. ©2020
1810 W Drake Dr.
Tempe AZ, 85283
sustainability.stryker.com
888.888.3433
Registration
Symbol Title
Number
Sterilized using
2501
ethylene oxide
Date of
2497
manufacture
2607
Use-by date
2493
Catalogue number
2492
Batch code
Consult
1641
instructions for use
1051
Do not re-use
2608
Do not resterilize
Do not use if
2606
package is
damaged
Does not contain or
N/A
presence of
phthalate DEHP
Description
Indicates a medical device that has been
sterilized using ethylene oxide
Indicates the date when the medical device was
manufactured.
Indicates the date after which the medical device
is not to be used.
Indicates the manufacturer's catalogue number
so that the medical device can be identified.
Indicates the manufacturer's batch code so that
the batch or lot can be identified.
Indicates the need for the user to consult the
instructions for use.
Indicates a medical device that is intended for
one use, or for use on a single patient during a
single procedure.
Indicates medical device that is not to be
resterilized.
Indicates a medical device that should not be
used if the package has been damaged or
opened.
Indicates product that does not contain or have
presence of the phthalate bis (2-ethylhexyl)
phthalate (DEHP).
Page 1 of 9
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Table of Contents
Related Manuals for Stryker MyoSure XL 50-501XL
Summary of Contents for Stryker MyoSure XL 50-501XL
- Page 1 Does not contain or Indicates product that does not contain or have BS EN presence of presence of the phthalate bis (2-ethylhexyl) 15986:2011 phthalate DEHP phthalate (DEHP). Stryker Sustainability Solutions, Inc. ©2020 1810 W Drake Dr. Tempe AZ, 85283 sustainability.stryker.com 888.888.3433...
- Page 2 Reprocessed MyoSure XL Tissue Removal Device Page 2 of 9 The MyoSure Tissue Removal System consists of the following procedural components: Reprocessed MyoSure XL Tissue Removal Device Description Control Unit Reprocessed Tissue Removal Device (Reprocessed Single Use Device) • Foot Pedal •...
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Page 3: Electromagnetic Safety
The use of accessory equipment in the patient vicinity not complying with the equivalent medical safety requirements of Reprocessed MyoSure XL Tissue Removal Device Page 3 of 9 this equipment may lead to a reduced level of safety of the resulting system. The use of accessory equipment outside the •... - Page 4 Reprocessed MyoSure XL Tissue Removal Device Page 4 of 9 this level of performance, the procedure should be aborted and the biomedical staff alerted to the observed Portable and mobile RF communications equipment, including cellular telephones and other wireless devices can affect problem.
- Page 5 Reprocessed MyoSure XL Tissue Removal Device Page 5 of 9 MyoSure Vacuum Canister control unit and Vacuum Source Foot Pedal Reprocessed MyoSure XL Tissue Removal Device FIGURE 2: SYSTEM CONFIGURATION 2. Place the control unit on top of a cart or other stable work surface. Plug the control unit power cord into the rear panel connector and a grounded AC power source.
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Page 6: Operation
5. Non-sterile person attached the tissue removal device vacuum tubing to the corresponding connection on the tissue trap Reprocessed MyoSure XL Tissue Removal Device Page 6 of 9 of the collection canister as shown in Figure 4. FIGURE 4: ATTACH VACUUM TUBE TO COLLECTION CANISTER ∣... -
Page 7: Troubleshooting
7. The reprocessed tissue removal device’s reciprocating action alternately opens and closes the device’s cutting window to Reprocessed MyoSure XL Tissue Removal Device Page 7 of 9 the vacuum flow thereby drawing tissue into the cutting window. 8. Cutting takes place when the reprocessed tissue removal device cutting edge rotates and translates across the reprocessed tissue removal device’s cutting window. - Page 8 (1) replace the product at no charge with a product that is at least functionally equivalent to the original product or (2) refund the purchase price of the product. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s property.
- Page 9 (30) days after delivery of the repaired or replaced product. When a product or component is replaced, the item provided in replacement will be the customer’s property and the replaced item will be Stryker’s property. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s...
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