smith nephew RENASYS Edge Pump Instruction Manual

smith nephew RENASYS Edge Pump

Specification

Replacement Parts and Accessories

The following products are available from Smith+Nephew. Contact Smith+Nephew customer assistance for availability and ordering information.

Storage Conditions

The system and all components should be stored in the following environmental conditions:

Wireless Quality of Services

The RENASYS0 EDGE pump overall wireless Quality of Services is implemented accordingly with three wireless communication functions. The RENASYS0 EDGE pump has two types of wireless communications interfaces: One Bluetooth Low Energy (BLE) and two NFC. The Bluetooth interface uses the legal manufacturer UUID and follows the Bluetooth 5 specification utilizing frequency hopping, latency and error correction. It also employs encryption to keep the data secure. The maximum communication range is around 20m. If BLE errors are detected, the RENASYS0 EDGE pump may respond in one or two ways:

• The pump could regard the error as fatal and abandon the communication, or
• Request or hint that the transmitter should send the data again in the hope that a subsequent attempt is successful.

The two NFC communication interfaces are ensured by using close range communications less than 50mm, reducing the likelihood of interference. The NFC in the top of the RENASYS0 EDGE pump communicates in close proximity to the external smart device and to transfer URL. The internal NFC located in the bottom communicates with the Canister to transfer canister configuration and status information.

• Bluetooth 5 Class 2 interface
• Type 2 NFC-A tag interface

Wireless Coexistence
RENASYS0 EDGE was tested for wireless coexistence for Tier 3 indicating a high likelihood of coexistence following the guidelines and test results from ANSI C63.27:2017.

IC (Industry Canada) Statement (IC ID 26135-EDGE)

Antenna Statement
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformement a la reglementation d’lndustrie Canada, le present emetteur radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou inferieur) approuve pour l’emetteur par lndustrie Canada. Dans le but de reduire les risques de brouillage radioelectrique a [‘intention des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope ayonnee equivalente (p.i.r.e.) ne depasse pas l’intensite necessaire a l’etablissement d’une communication satisfaisante. Canadian Department of Communications Compliance Statement CAN ICES-3(B)/NMB-3(B)

FCC Compliance (FCC ID 2AWH9-EDGE)

Modifications not expressly approved by Smith+Nephew could void the user’s authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/ TV technician for help

Radio frequency radiation exposure information
For body worn operation, this device has been tested and meets the FCC RF exposure guidelines when used with the Smith+Nephew accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Warranties

LIMITED WARRANTY

LIMITATION OF REMEDIES/LIABILITY:
The Smith+Nephew negative pressure wound care electro-mechanical pump (“Pump”) is warranted against defects in workmanship and materials for the warranty period specified below (“Warranty Period”). Smith+Nephew reserves the right to discontinue any Pump or change any Pump’s specifications or designs from time to time. For any Pump that fails to meet the foregoing warranty, this warranty provides and is restricted to replacement or repair (onsite service not included) as elected by Smith+Nephew in its sole discretion.

If Smith+Nephew replaces a Pump under this warranty and requests the Customer to return the Pump that was replaced, the Customer will be invoiced, at Smith+Nephew’s then-current list price, for the replacement Pump if the Customer does not return the replaced Pump within thirty (30) days after Smith+Nephew’s shipment of the replacement Pump. This warranty does not cover and is voided by any of the following: (i) a warranty claim not made within the first to occur of expiration of the Warranty Period or thirty (30) days following the failure of the Pump to perform as warranted; (ii) a Pump packaged or labeled by someone other than Smith+Nephew or its authorized agents; (iii) a Pump not used in compliance with the specifications, instructions or claims for use of the Pump;

(iv) a Pump used in conjunction with disposables, accessories or any other products not specified for use with the Pump; (v) a Pump used in conjunction with expired or reprocessed disposables, accessories or other products specified for use with the Pump; (vi) modification of the Pump; (vii) damage due to misuse, reprocessing, alteration, unauthorized repair or negligent handling or damage due to lack of care by the owner; user, or handler of the Pump including but not limited to storage, handling or cleaning; and (viii) any other damage inflicted to a Pump by the owner, user or handler. This warranty applies only to the original buyer from Smith+Nephew or its authorized distributor and is not transferable.

THIS WARRANTY IS THE SOLE WARRANTY OF SMITH+NEPHEW. ALL OTHER WARRANTIES OF ANY KIND OR DESCRIPTION WHATSOEVER, INCLUDING WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY AND FITNESS FOR A PARTICULAR PURPOSE, EXPRESSED OR IMPLIED, ARE EXCLUDED TO THE FULLEST EXTENT PERMITTED BY LAW.

Pump

• GENISYS NPWT electro-mechanical devices (inclusive of the power cord and power supply)

Warranty Period

Two (2) years from the date of delivery to the original buyer.

THE CUSTOMER’S SOLE REMEDY, AND SMITH+NEPHEW’S SOLE LIABILITY, FOR ANY CLAIM, WILL BE THE REPAIR OR REPLACEMENT BY SMITH+NEPHEW AS PROVIDED FOR IN THIS WARRANTY. EXCEPT FOR THIS LIMITED LIABILITY OF SMITH+NEPHEW, SMITH+NEPHEW UNDER NO CIRCUMSTANCES WILL BE LIABLE FOR ANY (A) CLAIM, FOR DAMAGES OR OTHERWISE, WHETHER ARISING FROM BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND WHETHER OR NOT BASED ON OR FLOWING DIRECTLY, INDIRECTLY OR AS A CONSEQUENCE OF A WARRANTY CLAIM, BREACH OF CONTRACT, A TORT, BREACH OF LAW, OR ANY OTHER CAUSE OR LEGAL THEORY, OR (B) DIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES, LOSSES OR EXPENSES ARISING FROM THIS AGREEMENT OR ITS PERFORMANCE OR LACK THEREOF, OR IN CONNECTION WITH THE SALE OR USE OF, OR INABILITY TO USE, THE PUMP, INCLUDING BUT NOT LIMITED TO, LOSS OF PROFIT OR ANTICIPATED SAVINGS, LOSS OF ANTICIPATED PROFIT, COST OF COVER FOR REPLACEMENT OR ALTERNATIVE PRODUCT, ECONOMIC LOSS, LOSS OF DATA, WASTED EXPENDITURE OR LOSS OF REPUTATION OR GOODWILL.

Icon and Symbol Glossary

Pump buttons

Pump lights

Therapy screen icons

Battery icons

Status bar icons

Icon and Symbol Glossary

Additional symbols

Trademark of Smith+Nephew. ©2022 Smith+Nephew. All rights reserved. This product may be covered by one or more US patents. See www.smith- nephew.com/patents for more information.

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