smith&nephew RENASYS GO User Manual
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smith&nephew RENASYS GO User Manual

Negative pressure wound therapy
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Clinician User Manual
REF 66021496
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
300ml
200ml
100ml
50ml
only

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Summary of Contents for smith&nephew RENASYS GO

  • Page 1 *smith&nephew RENASYS™ GO Negative Pressure Wound Therapy *smith&nephew RENASYS™ GO Negative Pressure Wound Therapy 300ml 200ml 100ml 50ml Clinician User Manual only REF 66021496...
  • Page 2 10966 175239 Rev02 260917.indd 2 27/09/2017 09:09...

  • Page 3: Table Of Contents

    Clinician User Manual only Table of contents Pause/adjust therapy Introduction Lock or unlock the keypad Device description Lock or unlock for homecare use Features and functions Turn off device Important information Monitoring NPWT Modes of operation Indications for use Clinician information – therapy time Contraindications Clinician information –...

  • Page 4: Introduction

    IEC medical equipment and medical electrical safety The RENASYS GO runs on AC mains power with an AC standard 60601-1-11 for use of medical devices in the power adaptor or internal battery power. The internal home healthcare environment.
  • Page 5 Canisters • 300ml and 750ml (300ml canister shown here) Canister clips 300ml 200ml Viewing window 100ml 50ml Tethered connector caps Canister tube Quick click connector 10966 175239 Rev02 260917.indd 5 27/09/2017 09:09...
  • Page 6 Proper use/correct orientation Incorrect orientation RENASYS™ GO device may also be used in a horizontal orientation, with device facing upward. However, to maximize canister volume and optimize canister over-capacity alarm, upright device orientation is recommended. Power inlet and power supply AC mains power inlet Power supply with DC cord 10966 175239 Rev02 260917.indd 6...

  • Page 7: Important Information Monitoring Npwt

    Important information Contraindications Monitoring NPWT Use of RENASYS GO is contraindicated in the presence Carefully monitor the patient, device, and dressing • Untreated osteomyelitis frequently to determine if there are any signs of bleeding, exudate accumulation (pooling), infection, • Exposed arteries, veins, organs or nerves maceration, or loss of Negative Pressure Wound •...

  • Page 8: Precautions

    9. When operating, transporting or disposing of 6. To minimize the risk of bradycardia, do not place NPWT in proximity to the vagus nerve. device and accessories, there is risk of infectious liquids being aspirated or contamination of 7. In the event a patient with spinal cord injury device assembly through incorrect use.

  • Page 9: Physician Orders

    22. Do not use in the presence of a flammable Physician orders anesthetic mixture with air or with oxygen or Prior to placement of RENASYS GO, the medical nitrous oxide. professional treating the wound must assess how 23. AC mains power can only be removed by to best use the system for an individual wound.

  • Page 10: Glossary Of Symbols

    Glossary of symbols Power Keypad lock Turns device ON and OFF. Lock keypad to restrict accidental adjustment of therapy. When lock is activated the light will illuminate solid Battery status indicator blue. Shows status of battery life. Audio pause Pauses alarm for approximately 2-3 minutes.

  • Page 11: Dressing Changes

    750ml canisters. maintenance. RENASYS GO canisters use an integral two stage Foam dressings should be changed every 48 to bacterial filter for protection of device against overflow 72 hours after the initial application of therapy. If and spread of aspirated micro-organisms.

  • Page 12: Installing Canister

    Installing canister Connect RENASYS™ Soft Port dressing and canister Ensure device is off. Connect Soft Port to canister tubing by pushing orange 2. Remove paper tape around canister tubing to quick click connectors together. An audible click release tubing to full length. indicates connection is secure.

  • Page 13: Device Start Up

    Device start up Language selection Device operates on both battery and AC mains power. To change language selection: If battery operation is required for first use of device, Turn device off. battery must be charged from AC mains power until battery status top indicator light illuminates solid green.

  • Page 14: Pause/Adjust Therapy

    Pause/adjust therapy Lock or unlock for homecare use The user interface may be locked for homecare use to Therapy may be paused by pressing prevent inadvertent changes to the therapy settings by Select button once. When paused, device will unauthorized users in a homecare environment. show a standby message on display screen and To lock for homecare use: pressure setting can be changed using Up...

  • Page 15: Modes Of Operation

    Modes of operation Clinician information — therapy time RENASYS™ GO offers both continuous and intermittent Device displays information which allows clinicians to modes. Selection of therapy mode setting is a clinical see therapy time (total hours and minutes of continuous decision based on physician judgment, wound type, or intermittent therapy) delivered to the patient.

  • Page 16: Clinician Information - Total Time

    Clinician information — total time Device displays total number of hours accumulated in active mode. This time cannot be reset. To access total time display screen: Turn device off. 2. Simultaneously press and hold Down + Select + Power buttons for 2 seconds.

  • Page 17: Battery Power

    Battery power Device can be used on battery power to provide the user greater mobility. During therapy, if battery level is low, the device can be plugged into AC mains power without interrupting therapy. Battery will recharge while therapy continues to be delivered. Battery status indication RENASYS™...
  • Page 18 Indicator Battery level Action Battery has up to 1 hour active Device should be plugged therapy remaining. into AC mains power to Battery status bottom indicator will charge battery and ensure illuminate solid yellow. continued delivery of Low battery alarm state (see alarm therapy.

  • Page 19: Safety Alarms

    Cautions – Lack of alarms: RENASYS GO device is equipped with high flow/leak, low vacuum and complete blockage/canister over-capacity alarms to alert users to these events occurring during therapy. These alarms are designed to activate based on changes in pressure status detected by device.
  • Page 20 High vacuum alarm: Vacuum level is higher than set point of NPWT by >15mmHg and device will stop delivering therapy. Event must be investigated by healthcare provider immediately and corrected. Alarm state Visual indication Display screen Audible alarm Beeps 2 times every 20 Status/alarm indicator: ! THERAPY STOP seconds...
  • Page 21 Low battery alarm: The system is operating on battery power and has detected depletion of available battery energy. If the power adaptor is plugged into AC mains power and connected to the device, the alarm will automatically reset. Alarm state Visual indication Display screen Audible alarm...
  • Page 22 Inactive alarm: Device has been left in standby mode for longer than 15 minutes. Either select pressure setting and start therapy or turn device off until therapy is required. Alarm state Visual indication Display screen Audible alarm Status/alarm indicator: ! Attention Beeps 2 times every 20 Inactive illuminates solid yellow...

  • Page 23: Troubleshooting Guide

    Troubleshooting Guide Alarm status with display screen Cause Remedy Low Vacuum Alarm With device actively creating vacuum, check wound dressing for air leaks. Look for loose or decompressed dressing appearance, listen for air movement around dressing and feel for areas less Device is unable to Vacuum level is lower than NPWT compressed or cooler in temperature.
  • Page 24 Alarm status with display screen Cause Remedy High vacuum alarm Press and hold power button for 2 seconds to turn device OFF. 2. Inspect connections and tubing to ensure they are free of obstructions. Ensure there Vacuum level is higher than NPWT Device has detected a are no kinks in canister tubing.
  • Page 25 Alarm status with display screen Cause Remedy Complete blockage/canister Check canister. If contents have reached over-capacity maximum volume indication (300ml or 750ml fill line), replace canister. 2. Inspect connections, tubing and Soft Port aeration disc (located on Soft Port, near There is a complete Device detects a complete the orange quick click connector) to ensure...
  • Page 26 Alarm status with display screen Cause Remedy Caution – Lack of alarms: If partial blockage occurs, the change in pressure status detected by device may not be significant enough to trigger alarm activation. Over time if blockage reaches point of full occlusion, complete blockage alarm will activate.
  • Page 27 Alarm status with display screen Cause Remedy High flow/leak alarm With device actively creating vacuum, check wound dressing for air leaks. Look for loose or decompressed dressing appearance, listen for air movement around dressing and feel for areas less Device detects a significant leak in There is a significant compressed or cooler in temperature.
  • Page 28 Alarm status with display screen Cause Remedy Inactive alarm Device has been left in standby Device has been left in Either select pressure setting and start therapy mode for longer than 15 minutes. standby mode without or turn device OFF until therapy is required. any keys being pressed •...
  • Page 29 Alarm status with display screen Cause Remedy Battery See battery status and alarm Battery partially Plug unit into AC mains power to charge section of manual for screen discharged or depleted. battery. messages. Keypad lock on User interface is locked. Unlock by pressing and holding keypad lock ►...

  • Page 30: Accessories

    Accessories Carry straps To attach carry strap to device: Feed end of open strap behind location pin on side of device. 2. Pull strap through and feed the end behind clip on carry strap. 3. Close clip to secure strap. 4.
  • Page 31 Carry bag (available for 300ml canister) To place device into the carry bag: Open zipper on both sides of bag and place face down on a flat surface with viewing flaps on top. 2. Place device face up on the open bottom section of the bag. 3.

  • Page 32: Maintenance

    NOTE: Smith & Nephew does not offer a plastic There are no serviceable parts in the device. Do not removal tool to be used with the RENASYS GO device. attempt to open device housing. Contact your Plastic removal tools may be purchased from vendors Smith &...

  • Page 33: Electromagnetic Compatibility

    Electromagnetic compatibility RENASYS™ GO (REF 66021496) This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2007. These limits and test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the device is used in a typical medical installation.
  • Page 34 – Guidance and manufacturer’s declaration electromagnetic emissions RENASYS™ GO (REF 66021496) The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...

  • Page 35: Specifications

    Specifications Pressure Setting 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200mmHg: tolerance +/- 10 mmHg Maximum 200mmHg Alarms General (all alarms) Priority Auditory sound level 46dB Over vacuum Indicator color Yellow High flow/leak Indicator color Yellow Alarm overall delay 60 seconds ±...
  • Page 36 Power requirements Device input voltage 21 VDC Device input power 36 Watts Mains adapter Smith & Nephew REF 66801558 Input: 100–240VAC, 50/60HZ, 34–58VA Output: 21VDC, 1.71A, 36W Fuses Internal electronic fuse, not user changeable Power cord Length: 1.8m maximum (Class II) Dimensions 7 x 8.3 x 3.5in.

  • Page 37: Caution Statements

    Caution statements Essential performance In order to ensure safe and proper performance, the (IEC 60601-1:2005, 3rd Edition) following conditions must be met: Essential Performance of the RENASYS™ GO, for safe • All assembly, operation, adjustment, modification, operation, is to maintain the vacuum delivered by the maintenance and/or repair should be carried out device, within its specification for pressure selected, to by qualified personnel authorized by...

  • Page 38: Limited Warranty

    LIMITED WARRANTY; Device Warranty Period LIMITATION OF REMEDIES/LIABILITY: RENASYS™ NPWT electro- Two (2) years from date The Smith & Nephew negative pressure wound care mechanical devices of delivery to original electro-mechanical device (“Device”) is warranted (inclusive of the power buyer against defects in workmanship and materials for the cord and power supply) warranty period specified below (“Warranty Period”).
  • Page 39 10966 175239 Rev02 260917.indd 39 27/09/2017 09:09...
  • Page 40 Smith & Nephew Medical Ltd. 101 Hessle Rd, Hull HU3 2BN www.smith-nephew.com www.globalwoundacademy.com Customer Care Center 1 800-876-1261 66021739 only ©2017 Smith & Nephew ™Trademark of Smith & Nephew 10966 Certain marks Reg. US Pat. & TM Off. 01/2017 (01)00040565127149(240)10966 10966 175239 Rev02 260917.indd 40 27/09/2017 09:09...

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