Models S 962-2 and 2W Instructions for Use Ver 1.4 Sept 2013

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Völker bed models S 962-2, S 962-2W from year of construction May 2009 – Instructions for use G92

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Version, Imprint, Type label Instructions for use G92 Version 1.4 (05.09.2013) for Völker bed models S 962-2, S 962-2W from year of construction May 2009

Type label Völker GmbH - Wullener Feld 79 - 58454 Witten - Germany Phone +49 2302 96096-0 - Fax +49 2302 96096-16 [email protected] - www.voelker.de

© by Völker GmbH 2009-2013 Völker GmbH Wullener Feld 79 58454 Witten GERMANY Tel.: +49 2302 96096-0 Fax: +49 2302 96096-16 e-mail: [email protected] Internet: www.voelker.de All rights reserved. Reproduction - even in part - is not permitted. We reserve the right to make changes to reflect technical advances. The contents of this document are subject to change without prior notification.

Next technical control Leakage current: xx,x µA Impedance: x,xx Ohm

26/2014

Degree of protection: IPX4

Made in Germany = 250 kg

= 185 kg

The type label is located on the inside of the head panel. Raise the rear section to read the type label. For further information on the type label, see Appendix  85.

Customers are advised to contact the responsible area sales representative before placing an order.

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Table of contents 1/2 Help  2 Version, Imprint, Type label  3 Table of contents  4 Foreword  6 Notes  7 General information  8 Designated purpose  10 General regulations, training/ instruction of users, further requirements  12 General safety notes  13 Functional description  18 Overview  19 Hand control with hook (version)  20 Transverse hand control (version)  22 Nurse hand control / nurse keypad  24 Nurse hand control with total lockout (Easy-Lock)(version)  26 Nurse control with complete lock (version)  27 Nurse control with individual lock (version)  28 Nurse control with individual lock/ automatic functions (version)  29

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Nurse control with individual lock/ Lying surface height  55 automatic/lower leg section functions Anti-Trendelenburg and (version)  30 Trendelenburg positioning  56 Trapeze bar and accessory holders, Comfort seating position  57 accessory rail  31 Bed extension (version)  58 Versions  32 Accessories  34 Cleaning and disinfection  59 Cleaning  60 Activation  36 Wipe and spray disinfection  60 General operating instructions  37 Spray lances  61 Preparation  38 Preparation for manual washing Electrical activation  40  61 Using the battery pack  41 Preparing the bed for the automatic Taking out of service  43 washing system  62 Functional check  44 Maintenance  64 Operation  45 Staff training  65 Key lock  46 Safety notes  65 Central castor adjustment  47 Maintenance schedule  67 Side rails  48 General safety notes  48 Side rails  49 Back section  51 Mech. rapid lowering of the back section / CPR function  52 Upper leg section  53 Lower leg section  54 4 of 104

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Table of contents 2/2 Technical check  68 Visual inspection  69 Functional check of the side rails  69 Functional check of the brakes  71 Functional check of the motors  71 Mains connection cable  71 Cabling  71 Housing  71 Mechanical check  72 Measuring in accordance with DIN EN 62353 (DIN EN 62353) 72 Grab handle  72 Further accessories  72

Appendix  80 Symbols used  81 Technical data  82 Classification  84 Type label  85 Service life/disposal  87 Manufacturer's declarations, forms, overview, electronic instructions for use  88

Troubleshooting  73 Table of faults  74 Service points  79

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Foreword We are delighted that you have chosen Völker beds. We are also grateful for the trust you have placed in our company and our products. This step is undoubtedly the result of extensive considerations and examinations of the requirements that you have on new care or hospital beds based on your previous experiences. You clearly had good reasons to choose a Völker bed. We promise you that Völker beds will not disappoint you.

Not for nothing do Völker beds enjoy a worldwide reputation as particularly innovative medical aids. This refers not only to the design principle, which was completely redeveloped by Völker. It also refers to the multitude of product advantages which are continually tested and improved for their practicality in practice. These will support the comfort of the patient and also help to reduce the load of daily care work. Every care or hospital bed has product features that are of practical benefit to their users. As far as we know, none of them offers the range of advantages that a Völker bed does.

Völker beds not only look great, but they also offer functions that can be controlled or adjusted mechanically, although most of them are controlled or adjusted using electric motors or electronic components. Having purchased these beds, the responsibility for their correct and appropriate use is transferred to you. Consequently, we strongly advise that you consult the enclosed instructions for use to learn about the technical features, handling and use of all the functions. We wish you every success with Völker beds. Völker GmbH

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Notes The Notes section contains information on the designated purpose of the product, as well as general safety notes.

Contents General information  8 Designated purpose  10 General regulations, trainer/ instruction of users, further requirements  12 General safety notes  13

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Notes | General information 1/2 General notes

Versions

Copyright protection

You have purchased a bed from Völker GmbH. This bed has been built in accordance with the applicable national and international standards and the regulations reflecting the current state of technology.

The bed can be realised in various versions. For a description of these variants, please refer to the „versions“ chapter  32.

These instructions for use may only be transferred to third parties with the written consent of Völker GmbH. All documents are protected under copyright.

Völker beds satisfy requirements in terms of safety and functionality. They are tested in accordance with international standards and bear the CE mark, which documents the beds' compliance with essential requirements for medical products. Please read the general safety notes  13. Please also note (with particular attention to any warranty claims) the further notes on the following pages.

These instructions for use also contain notes at certain points regarding various operating variants or different technical data for the various models or the S 962-2 model with the two motor variants DA01 and DA02. If areas of text are not universally valid, but instead specify a definite model or a definite motor variant, these text areas will begin by naming the model or variant with a grey background: Example: S 962-2: ..., S 962-2W: ..., S 962-2 (DA02): ..., S 962-2 (DA01): ... You can recognise the variant of your bed based on the type plate  85.

Warranty and liability Völker beds are supplied under an extensive warranty as exclusively described in the order confirmation. For details please contact Völker. We reserve the right to make technical modifications without notice as part of the further development of the beds which form the subject of these instructions for use. All specifications are non binding. Printing errors excepted. We accept no liability for damage and operational faults caused as a result of misuse and/or non-observance of these instructions for use. The portrayal of the accessories does

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Notes | General information 2/2 not necessarily match the actual product.

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Notes | Designated purpose 1/2 Intended use

borne by the accessories.

Völker bed models S 962-2 and S 962-2W are beds for medical use and are intended for use for patients in hospital wards, clinics and care institutions.

The maximum patient weight can therefore be taken from the following table:

The bed is intended for use by people over the age of 12 or who are taller than 146 cm. The beds safe working load is 250 kg. To calculate the maximum patient weight, 20 kg for the weight of the mattress and 45 kg for accessories as well as the weight borne by the accessories must be deducted from the safe working load when using the bed in application environments 1 and 2 (intensive and acute care) according to DIN EN 60601-2-52:2010.

Model

S 962-2, S 962-2W

Any use of the Völker bed other than for the purpose intended excludes the company from any possible liability.

Maximum patient weight

Safe working load

in application environment 1, 2

in application environment 3, 5

250 kg

185 kg

215 kg

Distribution of the safe working load onto the lying surface (as per DIN EN 60601-2-52:2010) Lying surface section

Share of the safe working load in %

Share of the safe working load in kg

Back section

45 %

112,5 kg

Seat section

25 %

62,5 kg

Upper leg + lower leg section

30 %

75 kg

When using the bed in application environments 3 and 5 (long-term and outpatient care), the values to be accounted for are 20 kg for the mattress and 15 kg for accessories as well as the weight

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Notes | Designated purpose 2/2 Non intended use

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Non intended use can be dangerous. This includes, but is not limited to:

Use of the bed for transport within a vehicle

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Overloading of the bed beyond the specified safe working load

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Incorrect actuation of electrical functions and uncontrolled positioning

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Operation of the care bed by the patient without having received prior instruction in how to do so

•

Use of other electrical equipment on the bed

•

Pulling on cables to move the bed

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Removing electrical plug connections by pulling on the cable

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Use of the bed on a slope of more than ten degrees of inclination (the bed‘s brakes are designed for an angle of inclination of no more than ten degrees)

•

Any attempt to move the bed while it is in braked position

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CAUTION If, in an emergency situation, it is impossible to avoid putting children under the age of 12 or people who are less than 146 cm tall in the bed, protective covers must be placed on the side rails. This also applies to the use of the bed by weak or confused patients. The use of the bed for children under the age of 8 is absolutely forbidden. WARNING The bed may not be placed right next to or stacked up with other equipment. If operation near to or stacked up with other equipment is necessary, it must be ensured that the operation of the bed is observed and correct use in this arrangement is checked.

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Notes | General regulations, user training / instruction, further requirements General regulations

User instruction

Flooring requirements

The bed must only be operated and used in accordance with its designated purpose, in line with the applicable regulations, the generally-acknowledged rules of technology and the stipulations of occupational safety and accident protection guidelines. The bed may not be operated in a faulty state that could endanger the patient, care staff or third parties.

The thorough induction of care personnel in the operation of the bed can be provided by Völker or its representative at the customer's request.

Increasingly overweight patients and occupants have caused a consistent increase in demands on hospital and care beds in recent years. Völker has addressed this topic by increasing the "safe working load" for the bed. The higher strain requirements are not limited to beds only they apply also to static and floor requirements. Therefore, we recommend that flooring in areas where the beds are used which is designed for this strain. These are floors classified as at least class 32 or 33 in accordance with DIN EN 685 and are professionally laid. They are floor coverings for areas intended for public and industrial use with moderate or heavy traffic.

User training The bed may only be operated by individuals whose training or understanding and experience offer surety for correct handling.

Attendance of such training can be certified and confirmed by Völker using the form provided for this purpose, specifying the name, date and signature. Patients must be instructed in the use of the bed before care personnel hand over the hand control to them. Other requirements Whoever is in charge of the activation, operation or preparation of the bed must have been given a copy of these instructions for use (in printed or electronic form) and have read them. To avoid operating errors and to safeguard the smooth operation of the bed, care personnel must always have access to the safety notes below.

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Notes | General safety notes 1/5 Warning symbols Information marked with this symbol must be read and its content strictly observed. DANGER represents an immediate threat of danger that can cause serious physical injury or death. WARNING represents potentially dangerous situations that can lead to serious physical injury or death. CAUTION represents potentially dangerous situations that can cause slight physical injuries. NOTE warns of potential damage to objects or property.

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Before first activation

WARNING If other equipment which has cables, air pipes or the like is to be operated on the bed, it must be ensured that these cables are routed so that they cannot become trapped in the movable parts of the beds and thus be damaged.

Before the bed is put into action for the first time, care personnel must read these instructions for use in full and with care. Before the bed is activated for the first time, care personnel must be instructed in the handling of the bed using the instructions for use. The potential dangers that can arise despite correct operation of the bed must also be pointed out in full.

WARNING Head and foot section are not connected to the potential equalisation. Electrical additional units should not be connected here.

Before and during use Before each use of the bed, the user must be sure that the bed is in a good, safe condition and that safe use is ensured (Functional check  44).

Position of the bed

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CAUTION To avoid injuries caused by falling, we recommend (except while care is being given) that the bed is set at its lowest position.

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Notes | General safety notes 2/5 Transporting the bed CAUTION When moving the bed, it must always be ensured that the mains connection cable does not touch the ground. The bed should only be moved over a solid floor. Never attempt to push it over obstacles of over 2 cm in height. The maximum angle of inclination of the floor must not exceed 10°.

Four castor central braking

One-sided load on the bed

CAUTION "Risk of accident" If the bed is not being transported, the castors must always be fixed, since the bed may be required as a support for when the patient stands up or lies down. If the bed rolls away while unbraked, this can lead to a serious fall. After activating the central holding brake  47 it must be checked that the bed is actually fixed, i.e. the castors are adequately braked.

NOTE In order to prevent onesided loads on the bed, it must not be used as a seat for persons other than the patient (i.e. visitors must not sit on the edge of the bed).

The bed can be in non-braked position even after first activation or reactivation, and consequently it must be checked that the castors are correctly fixed.

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Notes | General safety notes 3/5 Side rails

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It must be ensured that the patient does not come into contact with the side rail elements when the electrical lying surface adjustment mechanism is actuated. It is also important to ensure that no part of the body is sticking out through the side rails.

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If the side rails are used with a person whose psychological condition makes their use necessary, then it must be ensured that the hand control is kept out of their reach or its functions are locked. It is strongly recommended that side rail covers are used.

WARNING "Risk of entrapment“ In the case of patients whose physical or mental condition makes necessary to use side rails to protect them from falling out of bed, the following safety measures must be observed: •

The legal permissibility of using side rails must be ascertained.

•

The side rails may only be operated by trained care personnel.

•

Ensure that the side rails (or parts thereof) are either fully raised and locked in position or completely lowered.

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DANGER If these safety measures are not observed by care personnel, injuries can be caused to hands, knees, fingers, feet, legs and hips, along with haematomas and other injuries as a result of entrapment. In children or people who are less than 146 cm tall, non-observance of these guidelines can lead to death. WARNING "Danger of injury" If the side rails are damaged, the bed must not be used and must be repaired.

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Notes | General safety notes 4/5 Height adjustment DANGER "Risk of entrapment between the lower frame and/or floor and the bed frame when the bed is lowered"“ It must be ensured that no people, limbs, pets, bed linen or other objects are caught between the bed frame and the lower frame and/or floor. DANGER "Danger of movement" If any movement of the bed could represent a danger to the patient, all functions must be locked.

Use of oxygen equipment

Accessories WARNING Only original Völker accessories should be used! The installation of additional accessories (restraints etc.) is subject to the responsibility and due diligence of the operator.

DANGER "Risk of fire" Do not use any oxygen equipment other than that which is administered via nasal prongs or masks. Do not use this bed in a room where there is a risk of explosion. Provided it has been excluded (e.g. based on information in the instructions for use of the equipment being used) that the use of the equipment may cause the O2 concentration to rise to such a degree that there is an explosion risk, then the equipment can be used).

Use of lifting devices WARNING "Risk of injury" Only lifting devices approved by Völker may be used. The lifting devices specified are appliances that can be attached to the bed for transport purposes. Patient lifters can be used.

Rail spacers When using the rail spacer, please read the separate instructions for use for this accessory. During technical checks, the rail spacers should also be checked to ensure they are suitable for the size of side rail used.

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Notes | General safety notes 5/5 Cleaning and disinfection In order to maintain consistent functioning, the bed should be cleaned, disinfected and tested as soon as possible following each use, so that it can be reused immediately without risk. Incorrect cleaning/disinfection  59 of the bed can cause danger. Maintenance and repair Anyone responsible for carrying out maintenance and servicing must at least have read the safety notes for the respective bed model and be qualified in accordance with the relevant national regulations. The following applies for Germany: the staff requirements defined by the regulations governing the installation, operation, use and maintenance of medical devices must be ensured by the operator of the beds.

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To guarantee a trouble-free operation of the beds, the instructions for use of the bed must always be accessible to the servicing staff. After maintenance work or repairs have been carried out, an inspection/check corresponding to the work performed must be conducted. During this check, it must be determined that the bed can be used in accordance with the specifications without risk to patients, users or third parties.

Electromagnetic / static interference The beds of the S 962-2 and S 962-2W models satisfy the EMC requirements in accordance with the international requirements. The basis for testing is standard DIN EN 60601-1-2.

The technical check must be carried out at least once a year and after every lengthy period of non-use. Any discernible damage must be eliminated immediately.

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Functional description The features of the Völker care bed and its function are set out in the section Functional description.

Contents Overview  19 Hand control with hook (version)  20 Transverse hand control (version)  22 Nuse hand control / nurse keypad  24 Nurse hand control with total lockout (Easy-Lock) (version)  26 Nurse control with complete lock (version)  27 Nurse control with individual lock (version)  28 Nurse control with individual lock/ automatic functions (version)  29 Nurse control with individual lock/automatic/lower leg section functions (version)  30 Trapeze bar and accessory holders, accessory rail  31 Versions  32 Accessories  34

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Functional description | Overview Head board (Quick release, see fig. on right)

Adjustable side rails for back section, both sides

Adjustable back section

Adjustable side rails for lower leg section, on both sides Additional holders for drip stands, both sides, foot end (not shown)

Hand control Additional holders for drip stands, both sides, head end (not shown)

Foot board (Quick release, see fig. on right)

Rapid lowering of the back section (CPR) Casters

Adjustable lower leg section 4-column height adjustment

Seat section, fixed

Nurse hand control/ keypad (not shown) Holder for trapeze bars at the head end (not shown)

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Foot end double foot pedal for castor fixing (both sides) (Four-castor central braking)

Adjustable upper leg section

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Functional description | Hand control with hook (version) 1/2 Reverse: Back section up 1

Back section down 1

Upper leg section up

Upper leg section down

Anti-Trendelenburgpositioning 2

Auto-Contour 2 (Variant specific) 3

Lying surface up 4

Lying surface down 4

Hand control locked

Hand control unlocked

The Völker diagnostics system (optional) allows a time between 0 and 5 seconds delay to set the back rest movement to the 30° position  51 (Function is variant specific). 2 Leg end lowered 3 Back and upper leg section raised simultaneously 4 Pressing the “Lying surface up” and “Lying surface down” buttons simultaneously brings the bed into the horizontal position (Function is variant specific). 1

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WARNING When actuating motorised adjustments with the side rails raised. Ensure that the occupant does not have any contact with the side rails, and that no parts of his or her body or that of other people are sticking through the side rails or are trapped between the lying surface and the lower frame and/or floor. 20 of 104

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