Steeper S-Charge Скачать руководство пользователя

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S-Charge User Guide

Symbol

Definition

Source

Indicates the medical

device manufacturer.

ISO 15223- 1:2016

Reference no.

5.1.1. (ISO 7000-

3082)

Indicates the authorised

representative in the

European Community/

European Union.

ISO 15223-1:2016

Reference no

5.1.2

Indicates a carrier that

contains Unique Device

Identifier information.

MDR 2017/745

23.2(h)

ISO 15223-1:2016

Indicates the

manufacturer’s batch

code so that the batch

or lot can be identified.

ISO 15223- 1:2016

Reference no.

5.1.5. (ISO 7000-

2492)

Symbols Used on Product & Packaging

Certification mark that

indicates conformity

with the applicable

requirements for

products sold within

Great Britain (England,

Wales, Scotland).

https://www.gov.

uk/guidance/

using-the-ukca-

marking

The requirements

for accreditation and

market surveillance

relating to the

marketing of products;

Medical Device

Regulations.

765/2008/EC,

768/2008/EC

MDR 2017/745

(Articles 2, 13, 14,

20, 21, 22, 74 and

Annex V)

Single Patient - Multiple

use Symbol

ISO/DIS 15223-

1:2020(E) DRAFT

Reference no.

5.4.12. (ISO

7000-3706)

Содержание S-Charge

Страница 1: ...S Charge System Battery System with Display and Magnetic Charger User Manual ...

Страница 2: ...8 Waking up the S Charge 9 Low Battery 10 Charging the Prosthesis 11 Putting the Prosthesis on Standby 13 Charging Fault Indication 14 Care Cleaning and Safety 15 Important Information 16 Troubleshooting 18 Disposal 21 Warranty 22 Environmental Operational Conditions 23 Test Certification 24 Quality Assurance 25 Symbols Used on Product Packaging 28 ...

Страница 3: ...w you to easily activate deactivate charge and monitor the power status on your prosthesis Your S Charge System is operated using a standby button a visual display and a magnetic wall charger The display screen which is mounted into your prosthesis notifies you of the remaining power within the system and informs you if there is a charging fault For more information the image opposite shows the op...

Страница 4: ...f a button Simple to use button that switches to and from standby Raised mounting frame to prevent accidental activation Magnetic charger allows for easy connection to the power supply Quick release magnet protects against damage Automatic Sleep mode activation to save power Please only use your S Charge System with the prosthesis provided by your prosthetist The S Charge System is only compatible...

Страница 5: ...is in Sleep Mode C Warning Do not press the display screen as this may damage the S Charge System Starting the S Charge System Waking up the S Charge System 1 Once the system is in Sleep Mode it can be woken up by a short press of the Standby button 2 Once woken up the Display will show the current charge of the battery for 10 seconds before returning to Sleep Mode Note The S Charge System may req...

Страница 6: ...ed on 2 Once the power supply is turned on the charging display will be shown A Charging bar indicating that the battery is at 40 Charging the Prosthesis 1 When the battery level reaches 10 the display will flash the below screen on the press of the button if the system is active Note If the battery level then falls below 10 the system may turn itself off as a safety precaution It is important tha...

Страница 7: ...harge of the battery and the prosthesis will be activated Putting the Prosthesis into Standby The terminal device will not be operational during charging Do not use the wall charger if it is damaged and contact your supplier Important Information 1 The prosthesis can be deactivated by holding down the Standby button C for 1 5 seconds The system will then be in Standby Mode 2 The system will automa...

Страница 8: ...em has been designed to require minimum maintenance therefore if the device is not functioning as you believe it should please contact your prosthetic provider for guidance The display can be gently wiped clean using a soft cloth only The use of solvents or abrasives may damage the screen thus affecting the visibility of the text If used with a glove please ensure that water does not run down the ...

Страница 9: ...ilst the prosthetic limb is being worn Do not directly press the display at any time as this may cause damage to the S Charge System Important User Information Do not leave unattended for more than 12 hours when charging The System must only be charged with the S Charge System charger supplied by your clinician If the S Charge System has been in storage please leave in an ambient temperature 20 C ...

Страница 10: ... means Display not working when power button pressed Please contact your prosthetist for further assistance Distorted display 1 If the prosthesis is operational run until the batteries are flat then charge for 15 minutes 2 If the prosthesis is not operational but the distorted display is still visible connect the wall charger for 15 minutes 3 If the problem persists return the S Charge System and ...

Страница 11: ... they are flat then recharge the system should now function correctly If the problem persists return the S Charge System and the wall charger to your clinician for further assessment The S Charge System is an electrical device and should not be mixed with general household waste For safe disposal of this Device please contact the Clinic Hospital where this device was fitted or supplied who will ad...

Страница 12: ...he S Charge is 12 months The designed service life of the S Charge System is 2 years Other than the guidance outlined in Care and Cleaning no other maintenance is required for this system Storage and transport 20 C 4 F to 25 C 77 F Operational 5 C 23 F to 40 C 104 F Charging 0 C 32 F to 45 113 F Pressure range 700 1060 hPA 65 20 humidity Do not expose to EM emissions above 8kV contact 15kV air If ...

Страница 13: ...anufacture and supply of prosthetic and orthotic products MHRA Registration N 0000006617 FDA Registration N 9612243 Model N STP RP616 Continued compliance with the standard is monitored by a program of internal and external audits Applied Standards Test Certification The S Charge System and its associated components listed within this document have been tested and certified to the following standa...

Страница 14: ...movement within the European market This device is UKCA marked which indicates that the device meets safety health and environmental requirements It also indicates the device s compliance with the legislation of Great Britain England Wales Scotland and free movement within the market of Great Britain The design and manufacture of Steeper equipment and components are subject to a policy of continuo...

Страница 15: ...that the batch or lot can be identified ISO 15223 1 2016 Reference no 5 1 5 ISO 7000 2492 Symbols Used on Product Packaging Certification mark that indicates conformity with the applicable requirements for products sold within Great Britain England Wales Scotland https www gov uk guidance using the ukca marking The requirements for accreditation and market surveillance relating to the marketing of...

Страница 16: ...by the Forest Stewardship Council assurance that it is made with or contains forest based materials from FSC certified forests or reclaimed sources FSC Certification This product contains electrical and electronic components that may contain materials which if disposed of with general waste could be damaging to the environment Residents of the European Union must follow specific disposal or recycl...

Страница 17: ...4126 sales steeperusa com www steeperusa com STPPR046 Issue 5 June 2021 2021 Steeper Group All rights reserved EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague Netherlands KSA Authorised Representative AL EWAN MEDICAL COMPANY Office 14 1st Floor Elite Trading Centre Building 7934 King Abdul Aziz Road Al Rabi 13315 Riyadh Saudi Arabia Australian Sponsor ORTHOPAEDIC APPLIANCES PTY LTD OAPL 26 32 C...

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Steeper S-Charge, Руководство пользователя

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