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Related Manuals for LINET sentida 03
Summary of Contents for LINET sentida 03
- Page 1 User Manual and Technical Description sentida 03 D9U001WIS-0110 Version: 01 Publication Date: 2017-06 Manual shall be given to the User of this bed and should be read completely before putting the bed into service. Keep this manual accessible for future reference.
- Page 2 Manufacturer: Linet spol. s. r. o. Želevčice 5 274 01 Slaný Česká republika Tel. +420 312 576 111, Fax: +420 312 522 668, e-mail: info@linet.cz http://www.linet.com sentida 03 Author: LINET, s.r.o. Related links: www.linet.com D9U001WIS-0110 Version: 01 Publication date: 2017-06 Copyright ©...
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Page 3: Table Of Contents
1 Table of contents 2. Introduction 2.1 About these instructions for use 2.2 Symbols used in the text 6 2.3 Intended Use 7 2.4 General safety notes 2.5 Warnings and Precautions 3. Product overview 4. Commissioning 21 4.1 Delivery 4.2 Setting up the bed 4.3 Motor connections description 4.4 Battery 5. - Page 4 8.2 Extension for the SafeFree side guard ® 8.3 Side guard extension for 09 side guards 8.4 Lifting pole 8.5 IV rod 41 8.6 Patient surface extension 41 8.7 Accessories holder 9. Cleaning and disinfection 47 9.1 Cleaning 9.2 Disinfection 9.3 Maintenance of wooden parts 10.
- Page 5 17.1 Symbols used 62 17.2 Bed nameplate with UDI 18. Metamerism...
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Page 6: Introduction
2. Introduction 2.1 About these instructions for use Carefully read the whole instruction manual, it is designed to familiarize you with the correct use of your new bed. Always follow the instructions contained in this manual and use the bed only in accordance with these instructions. -
Page 7: Intended Use
The sentida 03 has been designed in accordance with state-of-the-art technology and gener- ally recognized safety regulations. Only use the sentida 03 when it is in perfect working order. Only use it for its intended use, safety and risk consciously and in accordance with these instructions for use. Malfunctions that... - Page 8 out of the bed. If an incontinent resident occupies the bed, incontinence protection must be used for the mat- tress. Avoid risk of entrapment during patient´s presence on the bed. The details of the nameplate must be observed. Make sure that the space underneath the bed is absolutely free of persons, feet, animals or other objects at any time, during any handling of the resident and operation of the bed.
- Page 9 Adjustments to the side sections (side rails) may only be made by nursing staff. When adjusting the patient surface positions, nursing staff must be convinced that the patient will not come into contact with the side rails, to avoid entrapment of hands, legs or other body parts. Extreme leaning out sideways of the upper body must be avoided.
- Page 10 Cleaning of the bed may only be carried out with a damp cloth. If the bed is not used properly, dangers can occur through: - Unauthorised operation electrical functions during uncontrolled positioning of the bed, - Using the bed for persons with a weight less than 40 kg, a height less than 140 cm and a BMI less than 17.
- Page 11 The following points must be observed: - The nursing home beds of Linet are intended exclusively for the occupancy of persons with a weight ≥ 40 kg, a height ≥140 cm and a BMI ≥17. This must be ensured, since persons with a body size or weight deviating from this average are exposed to an increased risk under cer- tain circumstances.
- Page 12 - Possible use deviating from this intended purpose represents a non-intended use and is ex- cluded from all claims of liability. Basic functions and uses of nursing home beds Modern nursing home beds have numerous bedding functions, which are described in detail in the instructions for use for the respective product.
- Page 13 Alter- natively the Linet mains cable hook can be used (see following diagrams). Under no account may fixed cable binders be used, since these could damage the mains cable if it is subject to unintentional tension.
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Page 14: Warnings And Precautions
/ foot end and under the patient surface. Danger! The sentida 03 should be left in its lowest position when the resident is unattended in order to prevent the resident from falling or injuries. Danger! Use of extension cables or multiple adapters that lie unsecured on the floor of the room should be avoided. - Page 15 Danger! Do not carry out any changes, attachments to and conversions of the sentida 03 without the manufacturer’s approval. Spare parts have to comply with the manufac- turer’s requirements. For original spare parts, this is always guaranteed. Adhere to the prescribed checks and tests!
- Page 16 Warning! For nursing home beds, the legs up position is not used for acute care in an emer- gency/shock position. Primarily, this function is used only for effortlessly setting the legs up position for therapeutic reasons! To avoid the risk of accidentally moving the bed to the Trendelenburg position, it is strongly recommended that the backrest is raised by about the width of a hand simultaneously with the legs up position.
- Page 17 However, as two drives independent of each other are used for the height adjust- ment for the sentida 03 model, it is necessary, depending on the adjustment cycle, to move the patient surface to the end position (highest or lowest position) at least...
- Page 18 Power supply connection cables could break when they are run over. Never run over power supply cables or other cables. Caution! Leave the bed in a fully braked condition. For models with axle braking (sentida 03), both axles must be braked.
- Page 19 Caution! When the sentida 03 was stored or transported at low temperatures, it needs to ad- just to the temperature for a certain time. When the adjustment time was too short or the temperature is not suitable, the sentida 03 can be damaged and fail. After strong temperature fluctuations, let the sentida 03 adjust its temperature for at least 12 hours.
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Page 20: Product Overview
3. Product overview The terms left and right have to be seen from the perspective of the person lying in bed. 1. Head section 5. Foot section 8. Thigh section 2. Backrest 6. Undercarriage cladding 9. Side panel 3. Handset 7. -
Page 21: Commissioning
4. Commissioning 4.1 Delivery The sentida 03 is usually assembled when delivered, or is assembled on-site by qualified spe- cialists. • Check bed components for any obvious damage to the packaging or its contents. If damage is evident, contact your local sentida 03 dealer. -
Page 22: Motor Connections Description
Since a nursing home bed is generally not equipped with a so-called equipotential connection, a combination with other electromedical appliances is not permitted without further safety measures being taken. Get in touch with the technical customer service for further information. An equipotential connection can be optio- nally provided, if required. -
Page 23: Handset
5. Handset Single fault tolerance of the handset: The handset of your comfort bed has single fault tolerance. This means that any adjustment of the bed by accidentally pressing a button or by playing with the handset is prevented. The functions of the handset are explained in detail in the following chapters. - Page 24 However, as two drives independent of each other are used for the height adjust- ment for the sentida 03 model, it is necessary, depending on the adjustment cycle, to move the patient surface to the end position (highest or lowest position) at least...
- Page 25 Caution! If the comfort bed is operated in institutions with medical supervision, the comfort seating and legs up position may only be released by medical personnel or only “un- der medical supervision” for safety reasons. The handset keys are released via the safety key! A Trendelenburg position is not required due to the intended use.
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Page 26: Alternative Functions
Warning! For comfort beds, the legs up position is not used for acute care in an emergency/ shock position. Primarily, this function is used only for effortlessly setting the legs up position for therapeutic reasons! To avoid the risk of accidentally moving the bed to the Trendelenburg position, it is strongly recommended that the backrest is raised by about the width of a hand simultaneously with the legs up position. - Page 27 Only thigh rest (TR) When both of these keys are pressed at the same time, only the thigh rest is adjusted (back rest is not moved). Bed egress position (BE) When both of these keys are pressed at the same time, the patient surface is raised, the back rest is moved into an upright position and leg rest is retracted.
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Page 28: Locking Functions Of The Handset
5.3 Locking functions of the handset A small key that is attached at the bottom on the hand- set must be used to lock and release the various modes on the handset. The following modes can be set by turning the lock on the top rear side of the handset: Locking mode: All functions are locked Basic setting Resident mode: Functions highlighted in blue are free to be used... -
Page 29: Function Test Handeset
Warning! The sentida 03´s design requires a clear height of less than 150 mm. Prior to every height adjustment of the bed, you must make sure that there are no persons, objects... -
Page 30: Handset Positioning
To continue adjusting the bed, the function key on the handset needs to be released and then pressed again. (e. g. mobile patient lift) The sentida 03´s design requires a safety clearance of less than 150 mm. Make sure before each use of movable lifting equipment that the free space beneath the sen- tida 03 is sufficient for the movable lifting equipment. -
Page 31: Moving And Braking
The sentida 03 may only be moved in its lowest position and without a patient. Moving the sentida 03 to other rooms with a resident or patient still in it do not comply with the intended use. -
Page 32: Mechanically Adjusting Calf Section
The sentida 03 is equipped with a spiral cable. A plastic hook is attached to the spiral cable. • If you want to move the sentida 03, hang the power supply connection cable´s hook to the upper edge of the head end. Thus, you can avoid that the power supply connection cable is run over. -
Page 33: Emergency Lowering Of The Backrest / Thigh Rest
6.3 Emergency lowering of the backrest / thigh rest The backrest and the thigh rest can be lowered manually and quickly without handset in the case of power failure. There are two red release handles on the housing of the patient surface motor for this: Standard operation Backrest gets released... -
Page 34: Side Guards
7. Side guards When using the side guards, particular care and caution should be taken: Side guards are first and foremost intended to protect the patient. On no account may the side guards be used as a means to restrain the patient. As soon as the mobility of the patient or resident is restricted, a court order is requi- red to use the side guards. -
Page 35: Devided Safefree ® Side Guards (10)
7.1 Devided SafeFree side guards (10) ® The SafeFree side guard is divided into two parts on each side of the bed. There is a release ® button on the bottom side of both ends of the handrail, with which the lock can be unlocked. The SafeFree side guard can be extended in 4 steps up to the height of 400 mm. - Page 36 Warning! Incorrectly locked side guards can slide down and cause a fall of the resident. Make sure the side guard has correctly engaged in each new position by shaking it. The correct engagement can also be visually inspected: The yellow locking buttons in the locking recess of the telescope mechanism must be recognizable on both sides.
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Page 37: Accessories
8. Accessories Danger! The use of accessories and combinations of products not authorised for the product can lead to serious hazards. This is why only accessories released by Linet and pro- ducts released for combination may be used. 8.1 Mattresses The bed is equipped with a mattress. -
Page 38: Extension For The Safefree
8.2 Extension for the SafeFree side guard ® In order to increase the height by approx. 6 cm (2,4 inch), an extension is available as accessory for the SafeFree side guard. ® Warning! An unsuitable extension, which is not intended for the SafeFree side guard, can be- ®... -
Page 39: Side Guard Extension For 09 Side Guards
8.3 Side guard extension for 09 side guards ca. 6 cm (2,4 inch) safety clearance If you want to attach the extension to the 09 side guards: • Pull up the side rails of the nursing home bed to the highest position. •... -
Page 40: Lifting Pole
8.4 Lifting pole The holder for the lifting pole is located at the head end of the patient surface frame. Warning! Grab handle and belt consist of high-quality plastic. However, all plastics are not un- conditionally resistant to aging, so that grab handle and belt can break or tear after long usage. -
Page 41: Rod
• Turn the infusion stand so that the bolt of the holder sleeve lies in one of the notches provided in the lifting pole holder. 8.6 Patient surface extension The sentida 03 offers two methods to extend the patient surface. A permanent extension of the patient surface, carried out at the manufacturer´s plant, or an optional temporary extension. Danger! - Page 42 Long-term (fixed) extension for the patient surface Can be folded down The sentida 03 can be delivered with a 10 cm (3,9 inch) or 20 cm (7,9 inch) extension for the patient surface. This patient surface extension can also be implemented afterwards in the fac- tory or by authorized qualified personnel.
- Page 43 • Pull on the foot end until you hear a clicking sound at the desired position with the rope being loose. In order to shorten the sentida 03 again, just follow the steps in reverse order: • Unlock the foot end by pulling the yellow rope and push it back in.
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Page 44: Accessories Holder
8.7 Accessories holder The accessories holder serves for hanging urine bag holders, urine bottle holders or similar accessories on it. It is attached to the side panel. The maximum permitted load of the accessory holder is 2 kg (4,41 lb). Caution! Before you attach the accessories holder, make sure that it cannot collide with other bed parts or fittings in the room. - Page 45 8.8 Reading light soluna LED The reading light soluna LED is inserted like the lifting pole or the IV rod into the accessory holder on the head-side of the bed. Switching function LED output To switch the LED output on and off press fi rst Autocontour and then up/down buttons simultaneously.
- Page 46 8.9 Handset holder Warning! Since the handset holder is flexible, it may not be used as assistance in standing up or as a handle. For SafeFree side guards: ® The handset holder is used to place the handset where the resident can reach it. As can be seen in the illustration on the right, it is attached on the handrail of the side guard.
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Page 47: Cleaning And Disinfection
To clean plastic or metal parts, use all-purpose cleaners that are only slightly alkaline (suds) and which contain tensides and phosphates. Dose the all-purpose cleaner in accordance with the specifications of the detergent manufacturer. Linet is not responsible for damage caused by the use of improper cleaning agents. -
Page 48: Disinfection
9.2 Disinfection The sentida 03 must be disinfected regularly, and at least before every change of resident. The bed must not be disinfected in automatic washing units or with spray water. Only disinfection agents may be used that correspond to the disinfection agents described in appendix 1 of DIN 68861 part 1: Phenol derivatives, 0.5-% aqueous solution:... -
Page 49: Service
10. Service 10.1 Maintenance and servicing The sentida 03 beds require very little servicing. This is because, during product development, care was taken to reduce that servicing work to a minimum, with low operating costs. In daily use, however, experience shows that products are also sometimes handled carelessly, and rough handling can also contribute to them aging more quickly and to the wear of certain components, on which the manufacturer can have no direct influence. -
Page 50: Wear
Please contact the customer service of Linet or a specialist company. Our customer ser- vice is available to you for any inquiries and to provide training and check lists for individual products. -
Page 51: Troubleshooting
- Unplug power plug of the bed, wait 3 minutes and then restart Handset locked, not correctly Handset does not work - Perform handset reset plugged in or defective - Unlock handset, check plug connection - otherwise, con- tact Linet Service department... -
Page 52: Storage And Transport
700 hPa – 1060 hPa (20.7 inHg to 31.3 inHg) Caution! When the sentida 03 was stored or transported at low temperatures, it needs to ad- just to the temperature for a certain time. When the adjustment time was too short or the temperature is not suitable, the sentida 03 can be damaged and fail. -
Page 53: Disposal
13. Disposal Linet ® is aware of the important role that the protection of our environment plays for future generations. The materials of this product are environmentally compatible. It does not contain hazardous substances on the basis of cadmium, mercury, asbestos, PCB or CFC. The noise emission and the vibrations meet the directives for premises. -
Page 54: Technical Data
16° ± 5° incl. thigh rest retraction by approx. 4 cm (1,57”) Tilting Kopf ca.15° / Fuß ca.15° Safe working load* sentida 03: 225 kg (496,04 lb) - 190 kg (418,88 lb) resident weight - 35 kg (77,16 lb) mattress + accessories Maximum weight ca. -
Page 55: Patient Surface Electric Motors
15.1 Patient surface electric motors 100-230 V AC 60 Hz Electrical connection Protection type IP 44 Protection class Output voltage 30 V depending on model variant (see nameplate) Operating time of motors max. 2 min. adjustment operation, 18 min. pause Power consumption up to approx. -
Page 56: Medical Bed With Movable Lifting Device
15.3 Medical bed with movable lifting device (for the purpose of the informative recommendation Annex BB of IEC 60601-2-52:2009) If the patient surface is lowered to a position higher than 400 mm (1,57”), the height of the free space under the medical bed must be at least 150 mm (1,97”) high, over a length of at least 500 mm (0,59”) on both sides of the symmetry plane of the patient surface. -
Page 57: Electromagnetic Compatibility
Mobile RF communication device (including end use devices like antenna cables and external antenna) should not be used closer than 30 cm (12 inches) from any part of this bed sentida 03, including cables specified by manufacturer. Otherwise this could lead to deterioration of functionality of this bed. - Page 58 Manufacturer instructions – electromagnetic emissions Emission test Compliance RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations / flicker emissions Complies IEC 61000-3-3...
- Page 59 Manufacturer instructions – electromagnetic susceptibility Immunity Tests Compliance level Electrostatic discharge (ESD) ± 8 kV for contact discharge IEC 61000-4-2 ± 15 kV for contact discharge Radiated RF 3 V/m IEC 61000-4-3 80 MHz – 2,7 GHz Proximity fields from RF wireless communi- 80 % AM at 1 kHz cations equipment See Table 1...
- Page 60 Table 1 – IMMUNITY to RF wireless communications equipment Test Immunity test level frequency Band (MHz) Service Modulation (MHz) 380 - 390 TETRA 400 Pulse modulation 18 Hz 430 - 470 GMRS 460, FRS 460 FM ± 5 kHz devia- tion 1 kHz sine 704 - 787 LTE band 13, 17...
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Page 61: Classification
16. Classification The sentida 03 comfort bed is classified as Class II medical device according to 21 CFR 880.5100, Product code LLI. 16.1 Applied standards The bed complies with the following standards and directives: • EN 60601-1:2006/A1:2013 • EN 60601-1-2:2007 •... -
Page 62: Product Labeling
17. Product labeling 17.1 Symbols used Black exclamation mark in yellow General warning! triangle Follow the instructions for use! White person on blue background Caution: Possible cable entrapment hazard! Black power cable in yellow triangle Caution: Possible foot entrapment hazard! Black foot in yellow triangle Caution: Possible hand entrapment hazard! Black hand in yellow triangle... - Page 63 Possible risk Switched-mode power supply Safe working load Maximum weight of patient Weight of bed Class II equipment (double isolation) Certification mark NRTL-USA-Canada of TÜV-Süd...
- Page 64 17.2 Bed nameplate with UDI Address of Distributor 1D Bar Code EAN128 (Serial Number) Manufacturing Date (Year-Month-Day) DI (Device Identifier) / GTIN (Global Trade item Number) 2D Bar Code (GS1 Data Matrix) DI+PI=UDI Symbols Serial Number Electrical Specification PI (Product Identifier)
- Page 65 18. Metamerism - the apparent equality of surfaces and decors - When different materials, different coloring and printing techniques with differing color sub- stances are used, slight differences in color are almost bound to occur under different lighting conditions (neon effect, shop lighting effect or exhibition effect are terms referring to such typical phenomena).
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