HUMAN CARE 72794 Side Rails FloorLine User Manual

HUMAN CARE 72794 Side Rails FloorLine

Important!
You must read the user manual for the bed as well as the user manual for the accessory prior to usage. Keep this booklet and information handy for future use.

Symbols

• ****WARNING symbol indicates a potentially hazardous situation which, if not avoided, could result in serious injury to the user or damage to property and/or the device itself.

• ****INFORMATION symbol indicates recommendations and information for proper, trouble‐free usage.

• ****WEIGHT CAPACITY symbol indicates
  maximum user weight for the product. Do not exceed this weight in any circumstance.

• ****CE MARKING symbol indicates product meets requirements of EU Directive 93/42/EEC (MDD) and/or EU Regulation 2017/745 (MDR).

• ****MEDICAL DEVICE symbol indicates
  that the product is a medical device according to the definition of medical device in EU Directive 93/42/EEC (MDD) and/or EU Regulation 2017/745 (MDR).

• ****RECYCLE according to local regulations.

• ****READ INSTRUCTIONS and ensure you fully understand them before using this product.

Product modification is not permitted.
Before use, always check that the product is not damaged or worn.

Human Care’s products are continuously being developed and updated to provide our customers with the highest quality. We reserve the right to make design changes without prior notice.
Always make sure that you have the most recent version of the manual which is available for downloading from our website at
www.humancaregroup.com.
Contact your local distributor if you have any questions about the product and its use.

Notice to user/patient in case of serious incident
Any serious incident that has occurred in relation to the product, should be reported to the local contact, who reports to the manufacturer, and the competent authority of the country in which the user/patient is established.

Compliances and Standards

Human Care is an ISO 13485:2016 certified
Swedish medical device company. The Quality Management System is in compliance with US 21 CFR part 820.
The product is CE marked in accordance with EU Directive 93/42/EEC (MDD) and/or EU
This User Manual informs you, as the operator, and your users, about the product features, assembly and operating functions necessary to ensure ease of operation, and safe handling of this product in its normal and expected environment.
You should therefore also regard this User Manual, as a practical reference book, to be kept near the product and readily available
at all times, for anyone involved in its use or operation. Regulation 2017/745 (MDR), as class I medical device.
The CE mark is on the product.
This bed complies with all requirements of the IEC/ISO International Standards: IEC 60601‐2‐52:2009
Is a warning triangle used for situations which require extra care and attention.

CAUTION!
Do not assemble or operate the bed accessory, before reading this manual, as personal injury or damage to product may occur!
Please contact Human Care in the event of any  uncertainties or questions.

Product lifetime
The product´s expected lifetime is ten (10) years, if the product is used as intended and maintained according to the manufacturer´s instructions, depending on the intensity of use and maximum load applied during use. If the product label is no longer legible, the product should be discarded.

Technical Specifications

Specifications measurements (mm / inch)

72794 (Side Rail 1/4)| H x L: 320 mm x 546 mm / 12.6” x 21.5”
72795 (Side Rail 1/2)| H x L: 320 mm x 680 mm / 12.6” x 25.6”
72797 (Side Rails 3/4)| H x L: 320 mm x 1370 mm / 12.6” x 53.9”

Responsibility of users

Instructions for the operator:
Please pay attention to your obligations, as the operator, in order to ensure the permanently safe operation of this medical product, minimising risks to the patient, user and/or third parties.
Any piece of technical equipment, electrical or otherwise, can prove hazardous, if not properly operated and maintained in accordance with its User Manual. It is recommended that you are informed of all operations and perform regular maintenance on equipment.

Definitions:

Operator
(e.g.: clinic, hospital, hospital management, nursing home), is every natural or legal person with property rights over the bed (including when subject to hiring, rental or lease arrangements). Responsibility for the safe operation of this bed accessory lies with the operator.

User
(specialist medical staff, nurses, doctors, attendants and care staff) are persons who, on the basis of their training, experience or thorough instruction, are entitled to operate the bed on their own responsibility, or to carry out work on it, or who have received instruction in the handling of this bed. Furthermore, they are able to recognize and avoid possible hazards as well as assess the clinical condition of the patients.

Patient, Resident or Guest
In this manual, a patient is described as any person being ill, infirm, disabled, in need of care, or otherwise occupying this bed.
Each time the bed accessory is allocated, it is recommended that the patient is instructed in all the functions that are important for him/her,
by the operator or user.

Safety Advice

Safety Symbol
In this manual the adjacent safety warning symbol is shown as:

This safety symbol does not replace all the written safety advice. You are instructed to read the safety advice and follow it precisely.

Safety for the operator
With the aid of this manual, which must be handed over together with the product, you must ensure that every user is instructed in the safe operation of the product before it is put into service for the first time.
Draw every user’s attention to the possible hazards that can arise if the product is not used properly. Pay attention to your obligations in order to ensure the permanently safe operation of this product to minimise all risks to the patient, user and/or third parties. Regular preventative maintenance is the Operator’s responsibility.
Only allow this product to be used by persons who have been instructed in its safe operation.
Make sure that stand‐in or temporary staff are sufficiently well instructed in the safe operation of the product.

Safety advice for the user
Make sure that the operator instructs you in the safe operation of this product.
Each time, before using the product, check that it is in perfect working order.
Make sure that there are no obstacles (eg: bedside lockers, chairs, hoists, wall mounted fixtures, or equipment etc.) which could impede any adjusting or movement of the bed.

Intended Use

The main feature of the Floorline beds is their ability to be lowered down to approximately 10 cm from the floor, this means that the side rail
accessories are very seldomly needed. However if a single caregiver needs to raise the bed in order to have an ergonomical work level
‐ they might need side rails on the opposite side of the bed to ensure the patient does not fall
out of the bed.

Accessory intended for the following Floorline Beds
This accessory should only be used with Floorline models from Human Care with the article numbers in the below table.
It is important that only Human Care accessories are fitted to Human Care beds, as any incompatible accessories can create hazards.

Assembly/Disassembly Instructions

Assembly Side Rail 1/4 (72794)

Content:

Assembly

Step 1. Mount the brackets (2L, 2R, 3L, 3R) in the holes * on the head end of the bed frame with the included screws (5).
Step 2. Slide the side rails (1L, 1R) onto the brackets and tighten the knobs (4).

• NOTE! When installing side rail 1/4 (72794) on older beds, you need to drill holes in the back of the frame. This is easily done
  by using the existing two holes on each side as a guide and drill until holes in the back of the frame appear. Use size drill size 8 mm.

Assembly Side Rail 1/2 (72795)

Content:

Assembly:
Step 1. Mount the brackets (2L, 2R, 3L, 3R) in the holes on the foot end of the bed frame with the included screws (5).
Step 2. Slide the side rails (1L, 1R) onto the brackets and tighten the knobs (4).

Assembly Side Rail 3/4 (72797)

Content:

Assembly:
Step 1. Mount the brackets (2L, 2R, 3L, 3R) in the holes on the head end of the bed frame with the included screws (5).
Step 2. Slide the side rails (1L, 1R) onto the brackets and tighten the knobs (4).

Operation Instructions

Human Care offers side rails in three different versions: ¾ length, ½ length and ¼ length. Below operation instructions are relevant for all of the side rail options from Human Care.

1. The side rails are assembled and in their upright position.
2. To collapse the side rails: pull the index plunger (release knob) at the head end of the side rail and slide down the side rail, untill the plunger locks.
3. To raise the side rails: pull the index plunger (release knob) and slide up the side rail, untill the plunger locks.

Using the side rails:
When lowering the bed ensure that the castors are positioned so the side rails will not damage the castors.

Pinch warning when collapsing and/or raising the side rails.

Maintenance and service

Inspection, care and maintenance check list
User inspections of this accessory should be carried out together with the Floorline bed every 6 months.

Check:

See bed description, accessories and

all functions

| •     Check for Damage/Cleanliness

•     Confirm Secure

•     Perform Adjustment/Cleaning

| OK| Faults: Action Cleaning

Parts to Order

---|---|---|---
VISUAL CHECK of the Components
Nuts/Bolts, Screws/Pins, Hinges/ Mounts/Bushes-component fixing points| Wear/Damage, Tighten & Secure

Clean & Free

| |
Painted steel components| Intact, Clean & Securely Fitted| |
Labels: Serial Number, Service, User/ Service Manuals| In Place & Readable| |
PERFORMANCE CHECK| | |
Accessories| Confirm Full Operation| |
Inspector’s Name:| Inspector’s Signature:| |
Inspection result:| Date:| |

If any problem persists, please call the customer service in your country.

Recycling
The product is built mostly from steel, or stainless steel. The surfaces have been finished with an electro‐coated powdercoating.
Incorrect disposal of this equipment and its component parts may produce substances that
are hazardous to the environment. Dispose of in accordance with all applicable national and local regulations.

HUMAN CARE SWEDEN (HQ)
Årstaängsvägen 21B
117 43 Stockholm
Phone: +46 8 665 35 00
Fax: +46 8 665 35 10
Email: info.se@humancaregroup.com
HUMAN CARE CANADA
10-155 Colonnade Road
Ottawa, ON K2E 7K1
Phone: +1 613 723 6734
Fax: +1 613 723 1058
Email: info.ca@humancaregroup.com
HUMAN CARE UNITED STATES
8006 Cameron Road, Suite K Austin, TX 78754 USA
Phone: +1 512 476 7199
Fax: +1 512 476 7190
Email: info.us@humancaregroup.com
HUMAN CARE NEDERLAND
Elspeterweg 124
8076 PA Vierhouten
Phone: +31 577 412 171
Fax: +31 577 412 170
Email: info.nl@humancaregroup.com
www.humancaregroup.com

References

• Safe Patient Handling Products and Walking Aids - Human Care

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