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Safety alarms

General

All alarms for RENASYS™ GO are determined to be "Low Priority," indicating that operator awareness is required

(IEC 60601-1:2005, 3rd edition and IEC 60601-1-8:2006).
In an alarm state with the audio paused, if a different alarm state occurs, the audio pause will be canceled, the

audio will sound and the display screen will indicate the new alarm state. When multiple alarm states are present,

the device's display screen will alternate between the display information for each alarm activated.

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. However, there are scenarios that may occur during therapy that

can impact alarm functionality. Therefore, it is important that patient, device and wound dressing are monitored at an

appropriate interval to ensure therapy is being delivered.

Over vacuum alarm:

The system has encountered an excessively high vacuum (of >255mmHg) and device will stop delivering therapy.

Event must be investigated by healthcare provider immediately and corrected.

Alarm state

Visual indication

Display screen

Audible alarm

Over vacuum

Status/alarm indicator:

illuminates solid yellow

! THERAPY STOP

! OVER VACUUM

Beeps 2 times every 20

seconds
Audio cannot be paused

High flow/leak alarm:

Device detects a significant leak in the system. Once corrected, alarm will automatically reset and

status/alarm indicator will return to solid green.

Alarm state

Visual indication

Display screen

Audible alarm

High flow/leak

Status/alarm indicator:

illuminates solid yellow

! WARNING

! LEAK

Beeps 2 times every 20

seconds
Audio may be paused

High flow/leak

Audio paused

Status/alarm indicator:

illuminates solid yellow

! AUDIO PAUSED

! LEAK

Paused for 2–3 minutes

Low vacuum alarm:

Vacuum level is lower than set point of NPWT by >15mmHg. Once corrected, alarm will automatically reset and

status/alarm indicator will return to solid green.

Alarm state

Visual indication

Display screen

Audible alarm

Low vacuum

Status/alarm indicator:

illuminates solid yellow

! WARNING

! LOW VACUUM

Beeps 2 times every 20

seconds
Audio may be paused

Low vacuum

Audio paused

Status/alarm indicator:

illuminates solid yellow

! AUDIO PAUSED

! LOW VACUUM

Paused for 2–3 minutes

10966 175239 Rev02 260917.indd 19

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Содержание 66021496

Страница 1: ...smith nephew RENASYS GO Negative Pressure Wound Therapy Clinician User Manual REF 66021496 only 200ml 100ml 50ml 300ml RENASYS GO Negative Pressure Wound Therapy smith nephew...

Страница 2: ...w 10966 175239 Rev02 260917 indd 2 27 09 2017 09 09...

Страница 3: ...rsion 13 Language selection 13 Starting therapy 13 Pause adjust therapy 14 Lock or unlock the keypad 14 Lock or unlock for homecare use 14 Turn off device 14 Modes of operation 15 Clinician informatio...

Страница 4: ...evice is designed to provide NPWT to a closed environment over a wound in order to evacuate exudates from the wound site to a disposable container which may promote wound healing via removal of fluids...

Страница 5: ...l 5 EN Canisters 300ml and 750ml 300ml canister shown here 200ml 100ml 50ml 300ml Canister clips Viewing window Canister tube Tethered connector caps Quick click connector 10966 175239 Rev02 260917 in...

Страница 6: ...py smit h neph ew RENASY S GO Negative Pressure Wound Therapy X smith n ephew RENASYS G O Negative Pressure Wound Therapy X smith n ephew RENASYS GO Negative Pressure Wound Therapy RENASYS GO device m...

Страница 7: ...riate wound types include Chronic Acute Traumatic Sub Acute and dehisced wounds Ulcers such as pressure or diabetic Partial thickness burns Flaps and grafts Contraindications Use of RENASYS GO is cont...

Страница 8: ...6 To minimize the risk of bradycardia do not place NPWT in proximity to the vagus nerve 7 In the event a patient with spinal cord injury experiences autonomic dysreflexia discontinue use of NPWT and...

Страница 9: ...anisters kits are single use devices Do not reuse 27 Do not apply SECURA No sting barrier film wipes directly to open wounds SECURA No sting barrier film is flammable Use in a well ventilated area Avo...

Страница 10: ...sary of symbols Equipment classification Isolation type BF applied part Keep dry Batch code ETL listing mark Storage temperature Serial number EU Not for general waste Date of manufacture Product cata...

Страница 11: ...If no leak is present and the patient is comfortable subsequent dressing changes should occur no less than 3 times per week 2 Gauze dressings should be changed 48 hours after the initial application...

Страница 12: ...py smith nephew 200ml 100ml 50ml 300ml RENASYS GO Negative Pressure Wound Therapy smith nephew Removing or changing canister 1 Hold orange quick click connector above wound to help ensure exudate does...

Страница 13: ...old Up Select Power buttons for 2 seconds 3 Language can now be selected using Up and Down buttons to scroll to desired language followed by Select button 4 Pressing Select button at this point will p...

Страница 14: ...ribed therapy mode and pressure setting and start therapy Note Therapy must be started for homecare lock to function 2 Simultaneously press and hold the Keypad Lock Audio Pause buttons for 5 seconds T...

Страница 15: ...screen will show which mode of therapy has been selected Clinician information therapy time Device displays information which allows clinicians to see therapy time total hours and minutes of continuou...

Страница 16: ...en T l a t o T e m i H x x x x x 4 Display will show for 5 seconds and then return to main menu Clinician information battery charge Device displays percentage of battery charge remaining To access ba...

Страница 17: ...een No action required Battery has up to 10 hours active therapy remaining Battery status top indicator will flash green No action required Battery has up to 6 hours active therapy remaining Battery s...

Страница 18: ...ery status bottom indicator will illuminate solid yellow Low battery alarm state see alarm section Device should be plugged into the AC mains power or therapy will discontinue When plugged into AC mai...

Страница 19: ...and device will stop delivering therapy Event must be investigated by healthcare provider immediately and corrected Alarm state Visual indication Display screen Audible alarm Over vacuum Status alarm...

Страница 20: ...FULL Paused for 2 3 minutes Cautions Complete blockage canister over capacity alarm Complete blockage canister over capacity alarm activation is driven by occlusion of filter located at top of canist...

Страница 21: ...Audio may be paused Low battery Very low 1 Status alarm indicator illuminates solid yellow 2 Battery status bottom indicator illuminates solid yellow RECHARGE V Low Battery Beeps 2 times every 20 sec...

Страница 22: ...creen Audible alarm Device not calibrated Status alarm indicator illuminates solid yellow DEVICE NOT CALIBRATED Beeps 2 times every 20 seconds Device failed alarm Device has an unrecoverable error Dev...

Страница 23: ...essing and feel for areas less compressed or cooler in temperature Address identified leaks with transparent film or adhesive gel patch 2 Ensure the following connections are secure Orange quick click...

Страница 24: ...ition continues device may have malfunctioned Contact your Smith Nephew authorized representative Over vacuum alarm P A R E H T P O T S Y V R E V O M U U C A P A R E H T P O T S Y t r a t s e R e c i...

Страница 25: ...ne replace canister 2 Inspect connections tubing and Soft Port aeration disc located on Soft Port near the orange quick click connector to ensure they are free of obstructions Ensure there are no kink...

Страница 26: ...mended to confirm adequate delivery of therapy In the event of heavy or viscous drainage drainage with sediment or when blood is present regular monitoring and more frequent dressing changes may be re...

Страница 27: ...engagement of canister to device 3 Disconnect Soft Port from canister tubing at orange quick click connector and insert tethered cap into both connectors If alarm condition continues there is a potent...

Страница 28: ...ator will illuminate solid yellow O I D U A D E S U A P I T C A N I E V Pressing audio pause button will pause audible alarm for approximately 15 minutes Alarm can only be paused once Device has been...

Страница 29: ...pressing and holding the keypad lock and audio pause buttons for 5 seconds Device failed alarm E C I V E D D E L I A F e s a e l P n r u t e R Device has an unrecoverable error Status alarm indicator...

Страница 30: ...to a wheelchair or IV pole when moving patients smith nephew RENASYS GO NegativePressureWound Therapy smith nephew RENASYS GO NegativePressureWound Therapy smith nephew RENASYS GO NegativePressureWoun...

Страница 31: ...bag 3 Pull front of the bag over top of the device and feed both parts of one zipper together 4 Close zipper on the other side of the bag 5 Once fitted ensure canister tubing can move freely 6 Excess...

Страница 32: ...ring must be carefully removed using a plastic removal tool ensuring that the inlet connector is not damaged during removal 2 Clean the device inlet port and carefully slide new inlet port O ring ont...

Страница 33: ...mains interruptions it is recommended that the device be powered from an uninterruptable power supply or battery NOTE UT is the a c mains voltage prior to application of the test level Power frequency...

Страница 34: ...e used Recommended separation distances between portable and mobile RF communications equipment and the device The customer or the user of the device can help prevent electromagnetic interference by m...

Страница 35: ...l delay 60 seconds 5 seconds Low vacuum Indicator color Yellow Alarm overall delay 30 seconds 5 seconds High vacuum Indicator color Yellow Alarm overall delay 30 seconds 5 seconds Blockage canister fu...

Страница 36: ...Ingress protection IP22 Environmental Storage and transport 14 to 131 F 10 to 55 C Operational temperature 41 to 95 F 5 to 35 C Relative humidity 30 to 70 RH Atmospheric pressure 700 mbar to 1 060 mb...

Страница 37: ...uthorized representative When necessary the device may be isolated from AC mains power by removing the detachable AC mains power adapter cord The electrical installation of the room must comply with t...

Страница 38: ...torage handling or cleaning and viii any other damage inflicted to a Device by the owner user or handler This warranty applies only to the original buyer from Smith Nephew or its authorized distributo...

Страница 39: ...10966 175239 Rev02 260917 indd 39 27 09 2017 09 09...

Страница 40: ...Rd Hull HU3 2BN www smith nephew com www globalwoundacademy com Customer Care Center 1 800 876 1261 only 2017 Smith Nephew Trademark of Smith Nephew Certain marks Reg US Pat TM Off 01 00040565127149 2...

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