LINET Tom 2 User Manual And Technical Description

LINET Tom 2 User Manual And Technical Description

Paediatric hospital bed
Table of Contents

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User manual
Tom 2
Paediatric hospital bed
and technical
description
D9U001K2B-0101
Version: 09
Publication Date: 2018-08

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Summary of Contents for LINET Tom 2

  • Page 1 User manual and technical description Tom 2 Paediatric hospital bed D9U001K2B-0101 Version: 09 Publication Date: 2018-08...
  • Page 2 Manufacturer: LINET spol. s r. o. Želevčice 5, 274 01 Slaný Tel.: +420 312 576 111 Fax: +420 312 522 668 E-mail: info@linet.cz http://www.linet.cz Tom 2 Paediatric hospital bed Author: LINET, s.r.o. Related links: www.linet.cz D9U001K2B-0101 Version: 09 Publication date: 2018-08 Copyright ©...
  • Page 3: Table Of Contents

    Isolating Foil .............................17 8 Assembly ........................18 Potential Equalisation........................18 Mattress Platform ..........................19 Tom 2 (1K) – Telescopic siderails with fixed bed ends ..............20 Tom 2 (1K) – Telescopic siderails with removable bed ends ............21 Removable bed ends ........................22 9 Operation ........................24 Initial Operation ..........................24...
  • Page 4 Disposal ............................50 16 Warranty ......................... 51 17 Declaration of Conformity ..................... 52 18 Technical Specifications ....................53 18.1 Basic Specification and Bed Dimensions ..................53 18.2 Environmental conditions ......................53 18.3 Electrical Specification .........................53 18.4 Electronic System of Tom 2 ......................54 D9U001K2B-0101_09...
  • Page 5: Symbols

    1 Symbols Warning Notices 1.1.1 Types of Warning Notices Warning notices are differentiated by the type of danger using the following key words:  Caution - risk of material damage.  Warning - risk of physical injury.  Danger - risk of fatal injury. 1.1.2 Structure of Warning Notices SIGNAL WORDS!
  • Page 6: Symbols And Labels On The Product

    Symbols and Labels on the Product Read user manual. Attention Thermal protection of transformer Only suitable for indoor use Protection against accidents due to electrical current – Applied part type B Safety isolation transformer, general CE mark Jack for attachment of conductor for potential equalisation Safe Working Load Maximum weight of patient...
  • Page 7 Safety class II Switched-mode power supply Machine wash max. 95°C (recommended 71°C for 3 minutes) Do not bleach Do not iron Suitable for dry cleaning Dry normal, low heat WEEE symbol (recycle as electronic waste, do not put into the household waste) D9U001K2B-0101_09...
  • Page 8: Description Of Label With Udi

    Description of label with UDI Fig. Serial Label with UDI (Tom 2) Address of Distributor Manufacturing Date (Year-Month-Day) DI (Device Identifier) / GTIN (Global Trade Item Number) 1D Bar code GS1-128 (Serial Number) Symbols Configuration number Electrical Specification Serial Number...
  • Page 9: Definitions

    Definitions Basic Bed Configuration the pricelist model configuration, not including a mattress Bed Weight The value depends on the product configuration, accessories or customer adjustments. Clearance of Undercarriage the height from the floor to the lowest point of the undercarriage between the castors, for the manipulation of accessories under a braked bed in the standard position Duty Cycle cycle of operation of the motor: time of activity/time of rest...
  • Page 10: Safety And Dangers

    2 Safety and Dangers WARNING! Tom 2 bed should be left in its lowest position when the patient is unattended in order to reduce risk of injury due to falls! WARNING! Siderails of Tom 2 should be located in the „up“ position to reduce the risk of the patient accidentally...
  • Page 11: Safety Instructions

    WARNING! If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. WARNING! An additional MULTIPLE SOCKET-OUTLET or extension cord shall not be connected to the MEDICAL ELECTRICAL SYSTEM. WARNING! During specific investigations or treatments the significant risks of reciprocal interference posed by ME equipment may occur.
  • Page 12: Conditions Of Use

    Patient:  Tom 2 medical bed is intended for patients with maximum height of 100 cm. Weight of patient + mattress + accesories can not be higher than safe working load (SWL - 75 kg). Personnel: ...
  • Page 13: Standards And Regulations

    3 Standards and Regulations The bed complies with the following standards and directives:  EN 60601-1:2006/A1:2013  EN 60601-1-2:2007  EN 60601-1-6:2010  EN ISO 15223-1:2012  EN ISO 10993-5:2009  EN ISO 10993-10:2014  EN ISO 14971:2012  DIN 32623:2009 ...
  • Page 14: Functioning

    For information concerning uses other than those outlined in the “Correct Use” section above, please NOTE contact LINET®. ® LINET®’s efforts in research, design and manufacture ensure LINET products are of the highest quality and fit ® for their intended purpose. However, LINET...
  • Page 15: Scope Of Delivery And Bed Variants

    CAUTION! Damage to the bed due to incorrect use!  Use 100 mm and 125 mm castors exclusively on flat, even surfaces without any gaps! Features – Tom 2 Model 1K (model no. see product label):  Mattress Platform ...
  • Page 16: Setup

    6 Setup Transport For safe transport, observe the following:  Ensure no cables are run over when moving a bed.  Ensure the mains cable is disconnect from the mains.  Ensure the mains cable is attached with a hook (at the head end of the bed). ...
  • Page 17: Battery Activation

    7 Battery Activation Placement of Control Section Removing the Isolating Foil Pull Isolating Foil Check if isolating foil is complete and undamaged as shown: If isolating foil is damaged, contact the manufacturer’s service department immediately. NOTE: It is recommended to wear gloves when removing the isolating foil. D9U001K2B-0101_09...
  • Page 18: Assembly

    8 Assembly WARNING! Risk of injury when working on the bed!  Ensure the bed is disconnected from the mains connection prior to assembly, disassembly and maintenance.  Ensure the castors are locked prior to assembly, disassembly and maintenance. CAUTION! Material damage due to incorrect assembly! ...
  • Page 19: Mattress Platform

    Mattress Platform The mattress platform consists of plastic sections. Correct placement of the patient on the bed: Fig. The patient orientation on the bed (Mini ACP is located at the foots of the patient). D9U001K2B-0101_09...
  • Page 20: Tom 2 (1K) - Telescopic Siderails With Fixed Bed Ends

    Tom 2 (1K) – Telescopic siderails with fixed bed ends CAUTION! Material damage due to excess load!  Ensure nobody burdens side rails or bed ends. Overview Tom 2 – Telescopic Siderails Fig. 1. Foot end 2. Telescopic siderails in upper position 3.
  • Page 21: Tom 2 (1K) - Telescopic Siderails With Removable Bed Ends

    Tom 2 (1K) – Telescopic siderails with removable bed ends CAUTION! Material damage due to excess load!  Ensure nobody burdens siderails or bed ends. Overview Tom 2 – Telescopic Siderails Fig. 1. Removable foot end 2. Telescopic siderails in upper position 3.
  • Page 22: Removable Bed Ends

    Ensure the accessories / extension placed in holder will not collide with bed end when removing it. Otherwise remove accessory / extension. The bed Tom 2 can be equipped with removable bed ends on the customer’s request. Removable bed ends allows easier access to the patient.
  • Page 23 To install bed ends:  Insert the bed end into the bed (1).  Put the bed end into the guides on top and bottom of the columns (2 & 3) on both sides.  Slide the bed ends down until it clicks into its place (4) (audible “click” will be heard). ...
  • Page 24: Operation

    9 Operation Initial Operation CAUTION! Material damage due to temperature difference!  If there is a considerable temperature difference between the bed and the place of operation (after transport/storage), leave bed unconnected for 24 hours to allo the temperature to equalise. Prepare the bed for service as follows: ...
  • Page 25: Status Faulty Battery

     The manufacturer recommends to replace the battery by qualified service organization after 2 (two) years of use. After this period the supposed service life of battery ends and the manufacturer cannot guarantee the battery service life after this period. ...
  • Page 26: Status Discharged Battery

    Status Discharged Battery The battery is regarded as discharged if the following condition is met:  Defined decrease of voltage depending on discharging current Status “discharged battery” is:  Status is indicated by the battery status indicator flashing quickly.  This status will be cancelled automatically when the bed switches to sleep mode.
  • Page 27: Manipulation

    10 Manipulation WARNING! Risk of injury when adjusting the bed!  Ensure there are no body parts between the mattress platform elements and the mattress platform frame when adjusting the bed.  Ensure there are no body parts below the mattress platform frame before adjusting the bed. ...
  • Page 28: Mini Acp (Supervisor Control Panel)

    10.1 Mini ACP (supervisor control panel) Mini ACP is main control panel of the bed. The Mini ACP control panel is placed on the frame of the bed under the foot end. Fig. Mini ACP (supervisor control panel) LED Battery charge status Central "STOP"...
  • Page 29: Night Bed Lightning

    Night Bed Lightning Tom 2 is equipped with undercarriage lightning. The lightning helps the patient or hospital personnel to better orientate in room with lowered or turned off light. The lowered intensity of lightning is set up after turning the bed on.
  • Page 30: Cpr Back Rest Release (Optionally Available)

    10.3 CPR Back Rest Release (optionally available) WARNING! Risk of injury due to lowering the backrest too quickly!  Ensure the telescopic siderails are in their lowest position!  Ensure there are no body parts between siderails and backrest. The bed permits mechanical lowering of the backrest for emergency resuscitation (CPR) procedures. There are two CPR control levers located under the bed frame under the head end for this purpose.
  • Page 31: Siderails

    10.5 Siderails The telescopic siderails are components of the bed. The siderails cannot be dismounted. The hospital personnel is responsible that siderails are locked in the highest position when the patient is on the bed. Fig. Fold siderail down To fold siderail down: ...
  • Page 32 10.5.1 Openable siderail bars (optionally) WARNING! Risk of damaging due to incorrect use!  Always ensure the openable bar is locked properly. Check the locking by pulling the bar up, down, towards and from you.  Never leave the bed with opened bars without supervision of hospital personell if the patient is on the bed. ...
  • Page 33 Locking pin Pull red bushing towards you Red bushing Center of button Close the siderail bar as follows:  Push the siderail bar down carefully until it latches into locked position.  Ensure the locking pin is secured in the bushing properly. CAUTION! Material damage due to incorrect using! ...
  • Page 34 10.5.2 Positions of siderails It is possible to fix siderails in 5 positions. Positions of siderails D9U001K2B-0101_09...
  • Page 35: Castor Control And Bed Transport

    10.6 Castor Control and Bed Transport CAUTION! Material damage due to incorrect transport or involuntary movement!  Prior to assembly, disassembly and maintenance, ensure the castors are locked.  Ensure the castors are locked while the bed is occupied and/or not being transported. ...
  • Page 36: Accessories

    Oxygen bottle holder  Pole for devices and accessories  chrome-plated NOTE: It is possible to attach additional IV pole compatible with Tom 2 to the bed. 10.7.1 Infusion Stand (integrated) WARNING! Risk of injury due using of unsuitable accessories! ...
  • Page 37 10.7.2 Accessory Rails Fig. Accessory Rail Load capacity:  Maximum load of 5 kg without leverage.  Maximum load of hook pair 10 kg. Accessories for hanging on the accessory rail:  Cannula holder  Urine bag holder  Urine bottle basket ...
  • Page 38: Mattress

    11.1 EffectaCare 20P and CliniCare 10P Mattresses EffectaCare 20P and CliniCare 10P for Tom 2 are designed for child patients on the pediatric departments. EffectaCare 20 Pediatric has monoblock polyurethane foam which is profiled on both sides. Top surface is profiled in 3 zones. CliniCare 10 Podiatric is double layer mattress. It has bottom cold polyurethane foam and top Viscoelastic foam.
  • Page 39: Technical Specification Of The Mattress

    Fig. Rotating of the mattress 1. Rotating - This means replacing the head and foot end of the mattress. 11.3 Technical specification of the mattress Parameters EffectaCare 20 P CliniCare 10 P (Foam) Material Polyurethane foam Polyurethane foam and Visco foam Load limit up to 75 kg up to 75 kg...
  • Page 40: Mattress Cleaning And Disinfectants

    11.4 Mattress cleaning and disinfectants  Mattress covers can be disinfected with most common disinfectants.  If disinfecting is not required, cleaning with soap and water should be enough to remove dirt stains.  Cleaning and disinfecting products based on solvent, bleach, abrasives or high alcohol concentrations can damage this product.
  • Page 41 Mattress parts to be cleaned Recommended Cleaning Agents (General cleaning) Top Cover , Bottom Cover Standard hospital detergents, Alcohol or Quaternary Ammonium based disinfectants, Chlorine based disinfectants containing up to 5000 ppm Chlorine, followed by rinsing with water and drying thoroughly before use.
  • Page 42 11.4.3 Complete Cleaning and Disinfection Cleaning Top/Bottom Cover: Use standard hospital detergents, Alcohol based cleaners or Quaternary Ammonium based disinfectants. Suitable Chlorine based cleaners can be used at a concentration of 1000ppm. Stronger concentrations of chlorine can be used if required, (up to 10,000ppm), with a maximum dwell time of five minutes followed by rinsing with water and drying thoroughly before use.
  • Page 43: Cleaning And Disinfection Of The Bed

    12 Cleaning and Disinfection of the Bed WARNING! Risk of injury when working on the bed!  Prior to assembly, disassembly, cleaning and maintenance, ensure that all adjustment functions are locked.  Ensure the bed is disconnected from the mains during cleaning process. ...
  • Page 44: General Instructions For Cleaning And Disinfection

     After drying the bed place the mattress back on the mattress platform.  After drying the bed check functions of the bed. 12.2 General Instructions for Cleaning and Disinfection 12.2.1 Daily Cleaning It is recommended to clean all parts of the bed which are touched by patient or personnel (e.g. siderails, bed ends, handset, lifting pole etc.) and all handles, all control elements and accessory rails.
  • Page 45: Choosing Of Detergents Or Disinfections

    Risk of damaging the bed due to use of incorrect detergent!  Always consult choosing of the detergent and its dilution with manufacturer of the detergents according to the material table below. Changing Part of bed – Tom 2 Material (*) Daily C&D Complete C&D patient C&D Telescopic siderails ...
  • Page 46: Troubleshooting

    13 Troubleshooting DANGER! Danger to life due to electric shock!  If a fault occurs ensure the electric motor, power box and other electrical parts checked by qualified personnel only.  Do not open protective covers of the electric motor or power box. Error/Fault Cause Solution...
  • Page 47: Maintenance

    14.1 Maintenance Work  ® The connector replacement should only be carried out by service personnel trained by LINET . For service related instructions, please refer to the service documentation.  Ensure the following maintenance work is performed every 12 months by the manufacturer or by a qualified service organisation trained and certified by the manufacturer.
  • Page 48: Functioning

     Have any defective parts replaced. 14.2 Functioning  Check that all bed adjustments reach the maximum position.  If necessary, clean or replace any worn areas and parts. 14.2.1 Electric Control Plug Connections  Replace O-rings on connectors.  Check the plug connections for dirt and defects.
  • Page 49 14.2.4 Safety checks WARNING! Incorrect safety checks can cause injuries!  Ensure that safety checks are performed by qualified or authorised personnel certified by the manufacturer.  Ensure that the safety checks are recorded in the service and maintenance log of customer. WARNING! A defective bed can cause injuries! ...
  • Page 50: Disposal

    PCB or CFC. Noise emissions and vibrations meet the directives for ® healthcare facilities. LINET has taken care to ensure all wood used in the production of its bed systems is responsibly source (Mahagony, Jacaranda, Ebony, Teak or wood from Amazonian / rainforests are not used.
  • Page 51: Warranty

    16 Warranty LINET® will only be held responsible for the safety and reliability of products that are regularly serviced and used in accordance with the safety guidelines. Should a serious defect arise that is in contrary with purpose of the bed: ...
  • Page 52: Declaration Of Conformity

    17 Declaration of Conformity D9U001K2B-0101_09...
  • Page 53: Technical Specifications

    NOTE Only qualified technical personnel is authorized to change fuses, tool and fuses of the same type are required NOTE Upon request, LINET ® can deliver hospital beds with electrical specifications that comply with regional standards (custom voltage, different mains plugs).
  • Page 54: Electronic System Of Tom 2

    Tom 2 requires special preliminary measures pertaining to EMC that necessitates installation and commissioning in conformity with the EMC information given in this Manual. Tom 2 is intended for the application in electromagnetic environment as specified below. The customer or user of the bed is responsible for these requirements are met.
  • Page 55 The high-frequency radiations are very low and unlikely to cause any interference to nearby electronic devices. High-frequency radiation Class B Tom 2 is suitable for all institutions, CISPR 11 including households and objects directly connected to the public low- Harmonic radiations Class A...
  • Page 56 Manufacturer’s Manual and Declaration - Electromagnetic Resistance 18.4.2 Resistance Test Test Level as per Level of Compliance Electromagnetic IEC 60601 Environment ± 6 kV for contact ± 6 kV for contact  Electrostatic discharge Ensure that the following ± 8 kV for air ±...
  • Page 57 Resistance Test Test Level as per Level of Electromagnetic Environment IEC 60601 Compliance  Conducted high 3 Vrms 3 Vrms Portable and mobile HF frequency phenomena 150 kHz to 80 MHz communication equipment should IEC 61000-4-6 not be used nearer than in the recommended distance calculated Radiated high-frequency 3 V/m...
  • Page 58 RF communications equipment and the Tom 2 Paediatric Bed The Tom 2 Paediatric Bed is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Tom 2 Paediatric Bed can help prevent...

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