ROPOX TF-200.03.0041 Toilet Support Arms User Manual

ROPOX TF-200.03.0041 Toilet Support Arms

Product Information

• Manufacturer: Ropox A/S
• Address: Ringstedgade 221, DK-4700  Naestved
• Contact: +45 55 75 05 00, Info@ropox.com UK
• Responsible Person: Qserve Group UK, Ltd
• Address: 49 Greek Street, W1D 4EG London, United Kingdom
• Contact: +44 740 885 936, info@qservegroup.com
• Expected Service Life: 5 years MDR
• Class: Class I Product Models:
  • Model: Straight, Part number: 40-40110 –
  • Model: Wave, Part number: 40-40115
  • Model: Straight Leg, Part number: 40-40120
  • Model: Wave Leg, Part number: 40-40125
  • Model: Straight Bariatric, Part number: 40-40140
  • Model: Wave Bariatric, Part number: 40-40145
  • Model: Straight Wave, Part number: 40-40150
  • Model: Straight Bariatric, Part number: 40-40151
  • Model: Straight Leg, Part number: 40-40152
  • Model: Length 76cm, Part number: 40-40153
• Intended Environments:
  • Professional Healthcare Environment
  • Homecare Environment Maximum User Weight according to DS/EN ISO 17966:2016:
  • 40-40110 and 40-40115: 190kg
  • 40-40150 and 40-40151: 255kg
  • 40 40140 and 40-40145: 385kg
  • 40-40152: 385kg
  • 40-40120, 40-40125, and 40-40153: 390kg
  • Ambient Temperature: Not specified Materials in Contact with Patient:
  • Ar  Covers: St. 37 powder coated ABS
• Configuration:
  • Length 90cm: Model: Straight, Wave, Straight Leg, Wave Leg
  • Length 76cm: Model: Straight Bariatric, Straight Wave, Straight Bariatric, Straight Leg
• Accessories: – Toilet roll holder:
• Item Number: 40-40910
• Get up/sit down fitting: Item Number: 40-40925
• Height adjustable unit:
• Item Number: 40-40907

Product Usage Instructions

1. Ensure that the user manual is always in close proximity to the product.
2. Pay attention to the symbols used in the manual: – Warning Symbol: Indicates potentially hazardous situations that can result in serious injury or death if not avoided. – Caution Symbol: Indicates potentially hazardous situations that may result in minor or moderate injury. It may also be used to alert against unsafe practices. – Notification Symbol: Used to notify correct use and handling of the product.
3. Follow the general safety guidelines mentioned in the manual.
4. The information in the manual is based on correct installation according to the provided installation instructions. Ropox cannot be held liable if the product is used in any way that differs from what is stated in the manual and/or installation instructions.
5. Ropox reserves the right to amend the manual and reference documents without prior notice.
6. The Ropox Toilet Support Arms are designed to provide stable support for users when getting up or sitting down on the toilet.
7. The product helps and encourages users to be more self-sufficient in their toilet activities.
8. Ensure that the product is used only in the intended environments, which include professional healthcare environments and homecare environments.
9. Check the maximum user weight according to DS/EN ISO 17966:2016 for the specific model being used.
10. The arm covers are made of St. 37 powder coated ABS material.
11. Depending on the model, the configuration of the product may vary in terms of length.
12. Additional accessories  such as a toilet roll holder, get up/sit down fitting, and height adjustable unit can be used with the product if needed.

Symbols used in this manual

Warning Symbol
Indication of potentially hazardous situation. If not avoided, it can result in serious injury or death.| **
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Caution Symbol
Indication of potentially hazardous situation which may result in minor or moderate injury. It may also be used to alert against unsafe practices.| **
Notification Symbol
This symbol is used to notify correct use and handling of the product.|

General safety

• This manual must be read and understood before use. Always keep this manual in close proximity of the product.
• The use, installation and service of this product must be in compliance with this manual to avoid accidents and serious personal injury.
• Never use or handle this product in other ways specified in this manual as it can result in personal safety hazards and/or cause damage to the product.
• Persons installing and/or using this product either as operator or user should have the necessary safety information and access to this manual.

****|

• Do not perform repairs, disassembly or assembly operations, add-ons, re-adjustments or modification of the product beyond what is described in this manual. These must be carried out by Ropox or Ropox authorized personnel. Do not perform service while in use.
• This appliance can be used by children aged from 8 years and above and persons with reduced physical, sensory or mental capabilities or lack of experience and knowledge if they have been given supervision or instruction concerning use of the appliance in a safe way and understand the hazards involved. Children shall not play with the appliance. Cleaning and user maintenance shall not be made by children without supervision.
• Do not use the product if it has defects or have become damaged before being repaired or replaced.

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****|

• The information in this manual is based on correct installation in accordance with installation instructions for this product.
• Ropox cannot be held liable if the product is used in any way that differs from stated in this manual and/or installation instruction.
• Ropox reserve the right to amend this manual and reference documents without prior notice.

Product Unit label

| This product is CE-marked in accordance with: European Medical Device Regulation (EU)2017/745 Council Directive 2011/65/EU, RoHS
---|---
| Manufacturer name and address
| Date of production
| Stock number
| Serial number
****| Consult manual for important safety related information, warnings, and safety precautions.
| Do not dispose as unsorted municipal waste. Product must be returned to a designated recycling station.
| Operating and storing temperatures may not exceed 5-40C°
| Consult the instructions for use

General requirements

Product information

Manufacturer| Ropox A/S Ringstedgade 221 DK-4700 Naestved +45 55 75 05 00 Info@ropox.com| UK Responsible Person| Qserve Group UK, Ltd
49 Greek Street, W1D 4EG London United Kingdom +44 740 885 936 3info@qservegroup.com
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Product models| Part number| Model| Configuration

• 40-40110
• 40-40115
• 40-
• 4012040-40125
• 40-40140
• 40-40145
• 40-40150
• 40-40151
• 40-40152
• 40-40153

|

• Straight Wave Straight Leg Wave Leg
• Straight Bariatric Wave Bariatric Straight Wave
• Straight Bariatric Straight Leg

|

• Length 90cm
• Length 90cm
• Length 90cm
• Length 90cm
• Length 90cm
• Length 90cm
• Length 76cm
• Length 76cm
• Length 76cm
• Length 76cm

Expected service life| 5 years
MDR Class 2017/745| Class I
Intended environments| This product is to be used only in: Professional Healthcare Environment Homecare Environment
Maximum user weight according to DS/EN ISO 17966:2016|

• 40-40110 and 40-40115 = 190kg
• 40-40150 and 40-40151 = 255kg
• 40-40140 and 40-40145 = 385kg
• 40-40152 = 385kg
• 40-40120, 40-40125 and 40-40153 = 390kg

Ambient temperature|

• -5 °C to +40 °C Transport and storage
• +5 to +40 °C Operation

Materials in contact with patient|

• Component
• __ Arm Covers

| Material description St. 37 powder coated ABS
Accessories

Item Number| Model/specification
40-40910| Toilet roll holder
40-40925| Get up/sit down fitting
40-40907| Height adjustable unit

Product description
Ropox Toilet Support Arms help create a stable support for when a user needs to get up, or for when sitting down. This helps and encourages the user to be more self-sufficient when going to the toilet.

Intended purpose
The Toilet support arms makes people with reduced mobility more self- reliant. The Toilet support arms provide the user with stable support and something to lean on when getting up or sitting down and for some people, it makes them able to use the toilet on their own. They come in two different shapes, and with different user loads, allowing the user to get the optimal toilet support arm for their individual need.

Intended operator
The intended operator may include all that have read and understood this manual exempt kids.

Clinical functions
This product does not offer clinical benefit for patients, when used as intended by the manufacturer.

Product dimensions
40-40110

40-40115 40-40120 40-40125 40-40140 40-40145 40-40150 40-40151 40-40152 40-40153

Instructions for use

Installation interfaces
All models of Straight and Wave (40-40110, 40-40115, ..20, ..25, ..40, ..45, ..50, ..51, ..52 and ..53)

Construction

• The wall must be made of a material suited for screw mounting and approved for damp rooms.
• The hatched area is the minimum area for reinforcement of the wall. Reinforcement from floor to ceiling is advisable.
• The Toilet Support arms from 40-40110 up to 40-40145 are all 900mm (35 ½”) long. The models 40-40150 and 40-40151 are 760mm (30”).

All support arms are load-tested according to DS/ISO 17966 the max user weight is:
Max. user weight according to DS/ISO 17966

• 40-40110: 190kg
• 40-40115: 190kg
• 40-40120: 390kg
• 40-40125: 390kg
• 40-40140: 385kg
• 40-40145: 385kg
• 40-40150: 255kg
• 40-40151: 255kg
• 40-40152: 385kg
• 40-40153: 390kg

Max. tensile load of upper screws

• 40-40110: 80kg
• 40-40115: 80kg
• 40-40120: 90kg
• 40-40125: 90kg
• 40-40140: 160kg
• 40-40145: 160kg
• 40-40150: 90kg
• 40-40151: 90kg
• 40-40152: 160kg
• 40-40153: 90kg

Note

• All dimensions are based on a fixed height of the toilet support of 800mm (31 ½”) above floor level. If a change of this height is required, the recommended dimensions must be
  changed accordingly.

• The unit is supplied with a set of 6 screws and rawlplugs suitable for mounting on a concrete wall. The fitter should always consider the material, condition and strength of the wall and use screws and rawlplugs suitable for the specific wall type.

• Attached is the mounting template with an indication of the 6 mounting holes on the bracket.

• User heights (upper edge of toilet support) and installation heights (upper holes in template / bracket).

Installation of product

• Mark the holes in the mounting template based on the desired height.
• Drill the holes, screw on the toilet support and click on the cover.

Warning!
Before putting product into use for the first time, load test it yourself, to ensure it has been properly fastened to the wall. Failing to do so may lead to serious fall injury of user, in case of incorrect mounting.

Operating the product

Warning!
The product should always be able to travel the full range of actuation without colliding with objects. Failing to do so will compromise the product stability.

Safety in use

Caution!

• The toilet support arm becomes slippery when its wet
• Be careful not to squeeze your fingers when turning the toilet support arm up /down
• Helper or other person can get foot underneath supporting leg
• Get up/sit down fitting, if not mounted correctly they can glide out off the bar

Cleaning

Cleaning can be done with lukewarm water and a suitable all-purpose cleaning agent. Use a cloth or soft sponge to wash the product. Dry the product of with a wrung cloth.

Note!

• Do not use cleaning agents containing abrasive e.g. scouring powder, steel wool, scouring sponge.
• This product is not designed to be sterilized. Autoclaving and sterilization beyond normal cleaning as this may possibly change the product safety and function.

Preapproved cleaning agents

Maintenance

The toilet support arm is maintenance free. For safety reasons, however, we regularly recommend inspecting all bolt connections and moving parts to ensure that no parts are loose and that wall mounts are intact.

Note!
Failing to comply with periodic maintenance may result of degrading of product function and safety.

Component part list

1 pc.
Toilet support arm, model varies **

1 pc.
Mounting template| 1 set
Wall plugs and screws

Note!
Ropox will make parts list and circuit diagrams available for extraordinary maintenance and repair beyond what is described in this manual. Repair beyond what is described in this manual may only be done by Ropox designated service personnel.

Environmental protection

The product is not intended to be disposed as municipal waste. Proper disassembly, sorting and disposal of components must be done by waste disposal professionals.

Accident reporting

The manufacturer of this product recommends any accident with this product that meets all of the following criteria reported to the appropriate authority as well as to the manufacturer.

1. There has been or could have been an event
2. The medical device is considered to be a contributing factor to the case, and
3. The event resulted or could have resulted in one of the following outcomes:
   • death – a patient, a user or a third party death
   • A serious deterioration of a patient’s health, a user’s or third party health status in the form of:
   1. Life-threatening disease
   2. Lasting damage or injury
   3. Necessary medical or surgical treatment to divert life-threatening illness, permanent injury
   4. Fetal death, fetal injury or congenital abnormalities.

ROPOX A/S

• Ringstedgade 221
• DK – 4700 Naestved
• Tel.: +45 55 75 05 00
• Fax.: +45 55 75 05 50
• E-mail: info@ropox.dk
• www.ropox.com

References

• Ropox - World's leading disability friendly solutions
• Ropox - World's leading disability friendly solutions

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