CliniCare 100 HF User Manual and Technical Description Ver 01 April 2017

Manufacturer: LINET spol. s r. o. Želevčice 5 274 01 Slaný Czech Republic Tel.: +420 312 576 111 Fax: +420 312 522 668 http://www.linet.cz E-mail: [email protected]

CliniCare 100 HF Hybrid Foam Mattress Replacement System Author: LINET, s.r.o. Related links: www.linet.cz D9U003VC0-0101 Version: 01 Printdate: 2017-04 Copyright © LINET, s.r.o., 2017 Translation © LINET, 2017

All rights reserved. All trademarks and brands are the property of the appropriate owners. The manufacturer reserves the right to changes in the contents of this manual that relate to the product´s technical regulations. It is for this reason that the contents of this manual may indicate differences from the current manufacture of the product.

D9U003VC0-0101_01

2/39

Content 1 Symbols ... 5 1.1 1.2 1.3

Warning Notices ...5 Other symbols ...5 Symbols and Labels on the Product ...6

2 Safety and Dangers ... 8 2.1 2.2 2.3 2.4

Safety Instructions ...8 Use and Storage Conditions ...9 Specification of Use ...9 Contraindication ...11

3 Standards and Regulations ... 11 4 System Description ... 12 4.1 4.2

Mattress ...12 SCU (System Control Unit) ...13

5 Scope of Delivery ... 13 5.1 5.2

Delivery ...13 Contents ...13

6 Installation and Operation ... 14 6.1 6.2 6.3 6.4 6.5

Placing CliniCare 100 HF on the Bed ...14 Installation of SCU (System Control Unit) ...15 Connecting Mattress with SCU ...16 Connecting Air Pipes with Mattress ...17 Disconnecting Air Pipes from Mattress (aka Switching to reactive mattress) ...18

7 Initial Operation ... 19 7.1

Inflation ...19

8 Use 8.1

... 20

Preparing the Bed for the Patient...20

9 Controls and Indicators ... 21 9.1 9.2 9.3

Control panel – CliniCare 100 HF with Micro-climate management ...21 Control panel – CliniCare 100 HF without Micro-climate management ...22 Pressure Control ...23

10 Additional Functions ... 25 10.1 10.2 10.3

CPR – Cardipulmonary resuscitation ...25 Power failure ...25 System faults ...25

11 Cleaning/Disinfection ... 27 11.1 11.2 11.3 11.4

General Guidance ...27 Routine Cleaning and Disinfection ...28 Full Cleaning and Disinfection ...28 Removing the Mattress Cover ...29

12 Maintenance... 30

D9U003VC0-0101_01

3/39

13 Storage ... 30 14 Disposal ... 31 14.1 14.2

Environmental Protection ...31 Disposal ...31

15 Warranty ... 31 16 Declaration of Conformity ... 32 17 Technical Specifications ... 33 17.1 17.2 17.3

Mechanical specification ...33 Electrical specification ...33 Electromagnetic compatibility ...34

18 Log 18.1 18.2

... 38

Delivery Log ...38 Service and Maintenance Log ...39

D9U003VC0-0101_01

4/39

1 Symbols 1.1

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! Type and source of danger!  Measures to avoid the danger.

1.2

Other symbols

1.2.1 Instructions Structure of instructions:  Perform this step. Result, if necessary. 1.2.2 Lists Structure of bulleted lists:  List level 1  List level 2 Structure of numbered lists: a. List level 1 b. List level 1 1. List level 2 2. List level 2

D9U003VC0-0101_01

5/39

1.3

Symbols and Labels on the Product

Read user manual Cover Materials are Fire Retardent to BS7175, Sources 0, 1 and 5 Do not iron. Do not use a cleaner containing Phenol. Do not wring. Regulary inspect the inside of the cover for contamination. Machine wash at 71 deg. Centigrade for 3 minutes Tumble dry on low heat setting. Handwash with detergent. Initial temperature of hot water should not exceed 50 deg. Centigrade. Disinfect using solution containing <1000 ppm of Chlorine (see Cleaning/Disinfection). Rinse with water. Dry. Attention, see accompanying documents Only suitable for indoor use CE mark of conformity with EU regulation 2x 1A(T) anti-surge fuse Protection against accidents due to electrical current – Type B applied parts Double insulation Power Switch I : On O: Off Alternating current Do not dispose of in a recyclable trash can

D9U003VC0-0101_01

6/39

1.3.1

Serial label The serial label is located on the back of the SCU (System Control Unit). The serial number and the model number can be found on the type plate. This information is required when contacting LINET.

Fig. 1 Serial label

D9U003VC0-0101_01

7/39

2 Safety and Dangers 2.1

Safety Instructions

2.1.1

Before use

 It is necessary to read the user manual before operating the mattress system.  Follow the instructions carefully.  Use the mattress system only as specified in this manual.  LINET shall not assume any responsibility for any damage or injury resulting from incorrect use.  Position the power cord so that there are no loops or kinks in the cable; protect the cable from mechanical wear and tear. Improper handling of power cord can cause an electric shock hazard, other serious injuries or damage to the mattress system.  Position the power cord so there is no risk of injuring the patient (e.g. choking hazard).  Regular inspection of the mattress interior to be carried out on a regular basis.  In case of any problem please contact manufacturer for help at installation, service or if an unexpected event occurs. 2.1.2

Installation

 Ensure that installation is performed in accordance with the instructions in this manual.  Ensure that maintenance is performed only by qualified personnel who have been trained by the manufacturer. 2.1.3

Usage

 Ensure that the mattress system is only operated by suitably qualified personnel or after receiving instruction from them.

 Only use the mattress system if it is in perfect working order.  Only use the system in clean environment.  Always hold SCU with scoop handle when moving.  Only use the mattress system with the correct power supply (see Electromagnetic Compatibility).  Replace any damaged parts immediately with original spare parts only.  Do not exceed the maximum patient weight (see Mechanical Specifications).  Do not use the SCU in near flammable gases. This does not apply to oxygen cylinders.  Do not cover SCU while in use.  Do not place SCU near extreme heat sources such as radiators.  Never handle the power plug with wet hands.  Disconnect the product from the outlet only by pulling the power plug. While pulling the power plug, always hold the actual plug, not the cord.

 Mattress and SCU must be checked at least once a day. Check that:  



the mattress is inflated to the required pressure the Low Pressure indicator is not pernamently illuminated in case of error refer to the chapter “System Faults” The handles located on the both sides of the mattress cover are designed only for manipulation with the mattress without load (without patient).

D9U003VC0-0101_01

8/39

2.2

Use and Storage Conditions DANGER!

Risk of injury due using CliniCare 100 HF system in incorrect environments!  Never use or store CliniCare 100 HF system in environments which contains flammable gases (except oxygen cylinders).

CliniCare 100 HF is suitable for use and storage in indoor environments meeting the following requirements: Ambient temperature 32 °F – 104 °F Relative humidity 30% - 75% Atmospheric pressure 795 – 1060 hPa Dust and water protection (SCU) IP 3X IP Code 3X Protected against ingress of solid foreign objects with diameter of >0.1 in. Flammability rating (mattress & mattress cover) Meets requirements of BS7177 Enviroment ISO 14001 2011/65/EU (RoHS) 2002/96/EC (WEEE) Electromagnetic compatibility IEC 60601-1-2

2.3

Specification of Use

Medical purpose:  The CliniCare 100 HF system is a dual-mode pressure area care system. The mode of use must be determined by a suitably qualified medical practitioner by means of a risk assessment.  Have CliniCare 100 HF used only by or under supervision of trained and qualified nursing personnel. Patient:  For patients without restrictions in terms of health, age or condition with low – moderate risk of creating pressure ulcers and for whom the mattress platform is suitable. Personnel:  Qualified medical staff (nurse, doctor) with medical school or university qualification. Use:  It is designed for use in all healthcare facilities, hospitals, nursing homes and community care as an aid to the prevention and treatment of skin injuries related to pressure damage. Bed:  Bed with mattress platform width from 86cm to 90cm and with length 214cm. Suitable beds:  Multicare  Multicare LE  Eleganza 2  Eleganza 3 / Eleganza 3XC  Image 3  Latera Thema  Beds which meet above criterias

D9U003VC0-0101_01

9/39

Transport:  In original packaging. NOTE: It is recommended the bed frame be used with the foot end extended so that the CCHF mattress can provide the maximum patient surface available.

D9U003VC0-0101_01

10/39

2.4

Contraindication WARNING!

Risk of injury due to incorrect use!  Before placing a patient on a CliniCare 100 HF mattress, always have a qualified person perform a risk assessment to ensure that the support provided is appropriate and fulfills the applicable local stipulations.  Do not use APT mode for patients undergoing cervical traction. STATIC mode can be used only under supervision of qualified person.  When using mattress replacement or overlay systems, make sure to use safe and appropriate siderail positions and bed height settings. Which positions and settings are safe and appropriate may vary with the type of bed frame and siderails.  CliniCare 100 HF mattress without System Control Unit is not intended for immobile patients. The CliniCare 100 HF system is contraindicated for patients with cervical traction or unstable:  spinal fractures  spinal cord injury  fractures at risk of complication by a moving support surface  mentally unstable patients

3 Standards and Regulations The mattress complies with the following standards and directives:  93/42/EEC  2011/65/EU  IEC 60601-1:2005/AMD1:2012/COR1:2014 IEC 60601-1-2:2007  IEC 60601-1-6:2010  ISO 10993-5:2009  ISO 10993-10:2010 The manufacturer adheres to a certified quality management system in compliance with the following standards:  ISO 9001:2015  ISO 14001:2015  ISO 13485:2003

D9U003VC0-0101_01

11/39

4 System Description 4.1

Mattress

The CliniCare 100 HF system is designed for use in all healthcare facilities, hospitals, nursing homes and community care as an aid to the prevention and treatment of skin injuries related to pressure damage. 4.1.1 CliniCare 100 HF CliniCare 100 HF is a hybrid foam including cell system. Cells are connected into two groups for pressure distribution. Air tubes inside the mattress are separate for these two groups. Cells also includes pressure valve to gain pressure from atmosphere when needed. The system can be connected to compressor thanks to outer valves. The system works as a separate mattress or in connection with compressor. Separate mattress redistributes the pressure according to patient’s position and movement. When the compressor is connected the mattress provides alternating therapy. In case of MCM version compressor also delivers air for MCM feature in mattress. Inside the mattress there is foam with different densities. On the top of mattress there is visco foam. Inside the cells there is also visco and PU foam. The pressure delivered by compressor can be adjusted by controller.

Fig. 2 CliniCare 100 HF mattress Top foam:  height: 5 cm  material: visco foam Middle section:  10 self-adjusting air cells absorb and displace patient weight  when used with SCU, air cells alternate in pressure, and micro climate management is optional  height: 11 cm  material:PU Base:  non-slip layer of cover  height: 2 cm Cover:  4-way stretch & waterproof cover

D9U003VC0-0101_01

12/39

4.2

SCU (System Control Unit)

The SCU inflates and deflates the air mattress. It is connected to the air mattress with a custom-designed air connector. The analogue electro-mechanical controlled SCU maintains the set pressure regardless of the patient’s weight distribution or position. The SCU is equipped with visual indicators for power failure or mattress low air pressure that may be caused by air pipe disconnection or other faults (see chapter “System Faults”).

Fig. 4 SCU for CliniCare 100 HF with MCM mode

Fig. 3 SCU for CliniCare 100 HF without MCM mode

5 Scope of Delivery 5.1

Delivery  

5.2

Upon receipt, check that the shipment is complete as specified on the delivery note. Notify the carrier and supplier about any deficiencies or damages immediately as well as in writing or enter them on the delivery note.

Contents

There are two versions of CliniCare 100 HF. Check the table below to recognize your version. CliniCare 100 HF with MCM mode:  Mattress with cover – CliniCare 100 HF  3 air connectors  SCU (System Control Unit) - Applied part type B  MCM and APT+MCM modes  User manual

D9U003VC0-0101_01

CliniCare 100 HF without MCM mode:  Mattress with cover – CliniCare 100 HF  2 air connectors  SCU (System Control Unit) - Applied part type B  APT and STATIC modes  User manual

13/39

6 Installation and Operation 6.1

Placing CliniCare 100 HF on the Bed WARNING!

Material damage due to incorrect placement of the mattress!  When using mattress replacement or overlay systems, make sure to use safe and appropriate siderail positions and bed height settings. Which positions and settings are safe and appropriate may vary with the type of bed frame and siderails. Before placing a patient on CliniCare 100 HF mattress, always have a qualified person perform a risk assessment to ensure that the support provided is appropriate and fulfills the applicable local stipulations.

WARNING! Malfunction of the system due to incorrect placement of the sheet!  Ensure the sheet is not preventing the functions of the mattress and system (e.g. due to overtightening the sheet over the mattress).

CAUTION! Risk of damaging the mattress due to use of inappropriate bed!  Ensure that the mattress dimensions and shape are correct for the bed frame and that the patient surface is flat and level once the mattress is in place.

6.1.1 Installation – CliniCare 100 HF Mattress Before placing mattress on the bed:  Unpack the mattress in area with clear, sufficient space for unfolding and expansion.  Inspect the mattress for shipping damage. In case of damage do not use the mattress and contact your distributor. To secure mattress on the bed:  Place the CliniCare 100 HF mattress (in good condition and free of any damage or wear) on the mattress platform, with the air pipe at the patients left foot side (foot symbol on the mattress cover determines placement) and position so that the mattress is centred.  Check if the mattress, air pipe or the SCU is not colliding with any part of the bed or if the mattress is not preventing side rails in its movement.  If the mattress is compressed (e.g. after storage) wait until it returns back to the original state.  If the mattress does not appear to have recovered, do not use it and contact your distributor. The CliniCare 100 HF mattress can now be connected to the SCU and inflated.

D9U003VC0-0101_01

14/39

6.2

Installation of SCU (System Control Unit) WARNING!

Risk of injury when installing SCU!  Make sure that your hands are not trapped between hook and foot board when using spring-loaded SCU hanging hooks.  Make sure that the SCU is installed securely so that it cannot slide or be accidentally knocked off.

WARNING! Risk of injuring the patient or damaging the accessories due to incorrect installation!  Ensure the SCU does not collide with any accessories placed on the bed.

CAUTION! Material damage due to incorrect installation of SCU!  Do not install SCU on linen rack on bed frame.  Make sure that the SCU is installed securely so that it cannot slide or be accidentally knocked off.

If foot end of bed frame is suitable for hanging SCU:  Hold SCU in one hand and unfold hooks on back with the other.  Hang SCU on bed end of bed frame (see Fig. 6). If foot end of bed frame is not suitable for hanging SCU:  Stand the SCU upright on the floor (see Fig. 5). NOTE: Take extra caution when manipulating the bed or moving around the bed when the SCU is standing on the floor.

Fig. 6 Installation of SCU on the foot end

D9U003VC0-0101_01

Fig. 5 Installation of SCU on the floor

15/39

6.3

Connecting Mattress with SCU

Installation:  Insert air connector 1 in the socket 2 at an angle of approx. 45° (see Fig. 7).  Push air connector 1 down until it clicks into place and air connector latch 3 secures the air connector against dropping off.

Fig. 7 Installation of SCU 1. 2. 3.

Air connector SCU air connector socket Air connector latch

D9U003VC0-0101_01

16/39

6.4

Connecting Air Pipes with Mattress

In order to switch mattress from reactive to active it is necessary to connect air pipes from the SCU to the mattress. 6.4.1 Mattress with MCM mode Connect air pipes as follows:  Connect all 3 air pipes with 3 air connectors on the mattress in the direction of arrow until it clicks into place.  Ensure that all 3 air pipes are connected properly by pulling them back.

Fig. 8 Connecting air pipes to the mattress with MCM mode 6.4.2 Mattress without MCM mode Connect air pipes as follows:  Connect both air pipes with 2 air connectors on the mattress in the direction of arrow until it clicks into place.  Ensure that both air pipes are connected properly by pulling them back.

Fig. 9 Connecting air pipes to the mattress without MCM mode

D9U003VC0-0101_01

17/39

6.5

Disconnecting Air Pipes from Mattress (aka Switching to reactive mattress)

It is possible to disconnect air pipes and switch the mattress from active to reactive. This means the mattress can be used without SCU. The mattress then provides reactive pressure redistribution through self adjusting air cells. 6.5.1 Mattress with MCM mode Disconnect air pipes as follows:  Press and hold the metal plate on the air connector.  Pull the air pipe out of the air connector.  Repeat on the remaining air pipes. Air pipes are removed from the mattress.

Fig. 10 Disconnecting air pipes from the mattress with MCM mode 6.5.2 Mattress without MCM mode Disconnect air pipes as follows:  Press and hold the metal plate on the air connector.  Pull the air pipe out of the air connector.  Repeat on the remaining air pipe. Air pipes are removed from the mattress.

Fig. 11 Disconnecting air pipes from the mattress without MCM mode

D9U003VC0-0101_01

18/39

7 Initial Operation The SCU is operated via the SCU control panel (see Control Panel).

7.1

Inflation

 Connect mattress to the SCU using air connectors.  Ensure that SCU is not covered and air flow around SCU is not obstructed in order to avoid overheating.  Position the power cord so there is no risk of injuring the patient (e.g. choking hazard) or blocking the bed positioning functions.

 Plug SCU power cord into suitable power socket. 7.1.1 Switching SCU ON/OFF To switch ON SCU:  Switch on SCU using green illuminated power switch on front of SCU (see Fig. Switching on SCU). SCU has been switched on. To switch OFF SCU:  Switch off SCU using green illuminated power switch on front of SCU (see Fig. Switching on SCU).  Disconnect power cable from the power source. SCU has been switched off.

Fig. 12 Switching on SCU 7.1.2

Inflation

Inflation:  Select required mode (see chapter “Control panel – CliniCare 100 HF”).  After switching ON the mattress will start to inflate, the indicator is illuminated during inflation. Set the pressure control dial into middle – green position (see Controls and Indicators).  Inflation may take up to 10 minutes. When inflation is complete, the indicator is no longer illuminated. When the inflation process is finished:  Check the mattress is still securely positioned on the bed frame. If indicator is illuminated longer than 20 minutes:  Check if air pipe is connected correctly.  Check the meaning of the system error (see System errors).

D9U003VC0-0101_01

19/39

8 Use 8.1

Preparing the Bed for the Patient DANGER!

Risk of injury when putting patient into bed! Before putting patient on the bed:  Ensure the mattress is fully inflated and placed correctly.  Alignment of the bed frame, side rails and the mattress should leave no gap wide enough to entrap a patient's head or body, or to allow egress to occur in a hazardous manner where entanglement with the power power cable or air connector may result. Care should be exercised to prevent occurrence of gaps by compression or movement of the mattress. Death or serious injury may occur.

WARNING! Danger of suffocation due to vapor permeable mattress cover!  Use the mattress cover correctly.  The nursing staffs are responsible for the safe nursing of the patient on the mattress cover.

CAUTION! Risk of infection due to lacking of cleaning or cover damage!  Ensure that no moisture gets into the mattress.  Ensure that no body fluids get into the mattress cover.  Mattress must be cleaned thoroughly between patients and decontaminated after patients with known or suspected infections.  If moisture gets into the system, notify LINET Service.

8.1.1

Preparation

 Inflate mattress (see Initial Operation).  Put a sheet loosely on the mattress if not prescribed otherwise by qualified personnel. NOTE: The air connector on the SCU must be kept uncovered for visibility and access. NOTE: It is possible to inflate mattress with patient on the mattress.

8.1.2

Putting Patient into Bed

 Lay patient on mattress. For an ideal lying position:  If additional blankets or sheets are used, make sure that ease of movement is sufficient.  Ensure that blankets, sheets, clothing etc. do not cause pressure sores (e.g. due to creases, seams etc.).  Do not place any additional sheets, blankets, pads etc. between mattress and patient.

D9U003VC0-0101_01

20/39