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Carilex Envelop Instructions For Use Manual

Anti-decubitus air alternating mattress replacement system
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Envelop
Anti-Decubitus Air Alternating Mattress Replacement
System
Instructions for Use

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Summary of Contents for Carilex Envelop

  • Page 1 Envelop Anti-Decubitus Air Alternating Mattress Replacement System Instructions for Use...
  • Page 3 Validity of the Details of the Device Documentation documentation This manual describes the Envelop System. It is part of the device documentation. Do not pass this device to a third party without these Instructions for Use. For the confirmation of the up-to-date status of the documentation, the end page of the Instructions for Use is marked by edition version.
  • Page 4 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop About This Document Information on the Manufacturer's Representative Carilex Medical, Inc. No. 77, Keji 1st Rd., Guishan District, Taoyuan City(33383), Taiwan(R.O.C) EU Representative: Distributor Carilex Medical GmbH Hanauer Landstraße 291 B60314 Frankfurt am Main Germany Tel:+49 69710475168 Email: info@carilexmedical.com...
  • Page 5 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Table of Contents 1 Important Notes for Safe Use 5-11 1.1 Designation of the Groups of Individuals 1.2 Notes for the Users 1.2.1 Instruction 1.2.2 Handing Over the Device 1.2.3 Maintenance and Installation...
  • Page 6 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Table of Contents 5 Features 17-21 5.1 Control Panel 5.2 Side Panel 5.3 Rear Panel 6 System Installation, Operation, Transfer and Transport of Patient 22-23 6.1 System Installation 6.2 Operation 6.3 Transfer and Transport of Patient...
  • Page 7 Operators An operator (surgical supplier, health insurance, clinic, etc.) is any legal person, who owns Envelop System and uses it, or on whose behalf the device is in use. The operator is responsible for providing a safe device and to instruct the user properly on the operation and safe use of the device.
  • Page 8 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Important Notes for Safe Use Notes for the Users Note that the Envelop System should only be used by persons who have been trained in the operation and the intended use of the device. Training on 1.2.1 Instruction...
  • Page 9 Important Notes for Safe Use Procedures for Accident Prevention The Envelop System is made according to the current state of the art technology and is reliable. However, hazards may arise during the use of this device if it is operated by untrained personnel or it is not operated as described in these Instructions for Use.
  • Page 10 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Important Notes for Safe Use Purpose of the Device To ensure the security of patients and users, the device may only be used for its intended use. Intended use 1.4.1 Intended Use...
  • Page 11 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Important Notes for Safe Use EMC notices 1.4.3 EMC Compliance Statement Use of accessories and/or cables other than those specified or provided by the manufacturer of the SR388 may negatively affect EMC performance.
  • Page 12 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Important Notes for Safe Use Safety Information and Symbols of These Instructions for Use The safety instructions in this Instructions for Use are marked with symbols and key words. Signal words like WARNING, CAUTION or ATTENTION designate the classification of the risk.
  • Page 13 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Important Notes for Safe Use 1.6.4 Additional Symbols to the Safety Information Additional symbols to the safety information are those listed below Machine Wash Warm : Max. 60°C Machine Wash Warm : Max. 71°C...
  • Page 14 (6) Ascertain that the patient's weight does not exceed the weight allowed on the bedframe and the maximum therapeutic capacity of the anti-decubitus system. WARNING To avoid the risk of electric shock, the Envelop system must only be connected to a supply mains with protective earth.
  • Page 15 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Security Norms Advice (1) Use the mattress within the bed side rails and assure that the space between the sides of the bedframe and the mattress is not big enough to insert the patient’s head and neck. Neglecting this could cause serious injuries to the patient.
  • Page 16 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Delivery and Storage Packaging Envelop System is supplied in sturdy cardboard packaging. All packaging materials are recyclable and can be separated. Delivery Control Check immediately after delivery of the device: •...
  • Page 17 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Device and Functional Description Device Description Power unit The power unit is used as the housing for the air source as well as control features: • A control panel with buttons and lights to adjust the air system.
  • Page 18 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Device and Functional Description Operation and Functional Test To perform a functional test and at the initial start-up of the power unit take the following actions: • Fully lay out the mattress. Both air hoses must be able to move easily without any kinks or pressure points.
  • Page 19 LED will be lit. To turn on the power unit, press Power/Standby and the standby orange LED will be off. Envelop (Static Mode) Envelop Mode is the therapy in which all air cells maintain constant pressure support and maximize patient's contact area to redistribute pressure.
  • Page 20 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Features AP Redistribution (Dynamic Mode) AP Redistribution Mode is a therapy mode in which air cells alternate in an A-B-A-B (odd and even number of air cell sets) pattern to relief pressure and increase blood flow of the patient tissue.
  • Page 21 Envelop system is equipped with multi-languages setting including Espanol, Italiano, Deutsch, Francais and English. The default language of the system is English. To change the language, simply press Envelop and Fowler Boost button when the rocker switch is on and the system power is off.
  • Page 22 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Features Side Panel Left Side Panel Rocker Switch (1) Main power switch of power unit Power Receptacle (2) Three pin IEC 60320 C14 AC inlet to accept power cord set with C13 connector.
  • Page 23 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Features Rear Panel Convenient Handle (1) It provides additional gripping surface for user to carry the power unit. Hanger Hooks (2) The hooks are designed to fit with multiple footboard widths.
  • Page 24 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop System Installation, Operation, Transfer and Transport of Patient System Installation (1) Remove the existing mattress. (2) Put the mattress on the structure of the bedframe with the logo at the foot of the mattress.
  • Page 25 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop System Installation, Operation, Transfer and Transport of Patient Side Bolster Inflation and Deflation of Envelop Bariatric M-set Envelop Bariatric M-set has one extensional bolster located on each side of the core mattress. The bolster control valves are located at the food end of the mattress underneath the flap on the top cover labeled "Control Valve".
  • Page 26 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Application Mandatory It is mandatory to select proper bedframe size for the Envelop System. bedframe size Do not operate the Envelop System without safe installing of the mattress onto the bedframe. Make sure that the fixing of the mattress does not impede the adjustment mechanism of the bedframe.
  • Page 27 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Cleaning and Disinfection In order to prevent cross-contamination, the cleaning and disinfection of the entire the Envelop System must be carried out between uses with different patients. WARNING Electric shock! Check electrical Water has a high electrical conductivity.
  • Page 28 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Cleaning and Disinfection Cleaning When using the Envelop System in non-clinical areas the users or appropriately trained cleaning personnel can carry out the cleaning of the device. WARNING Remove the power cord set from the wall socket before cleaning of the power unit.
  • Page 29 Envelop System and the actual hygiene directives for disinfection. The the operator disinfection of the Envelop System or parts of it can be performed only by trained personnel, who are familiar with the hygiene requirements of the institution.
  • Page 30 Care and Maintenance Inspection The safe operating condition of the Envelop System has to be checked at each use by the operator or during use by the patients and at least once in a year in particular with regards to the following: •...
  • Page 31 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Troubleshooting Problem Control Procedure Possible Solution 1.1) Verify that air flows liberally 1.1) It may be necessary to move across the tubes and the mattress the tubes or the manifold if they are manifold.
  • Page 32 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Technical Data The Envelop System is suitable for continuous operation. Power unit Model ..................SR388 Dimensions(W x H x D)..........37.5 x 32 x 18.5cm Weight....................6Kg Electrical Rating..........100-240Vac 50/60Hz 1.4A Power Consumption.........Max. 60W (normal operation) Fuse Rating................T3.15A 250V...
  • Page 33 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop EMC Declaration Declaration of Conformity For EN 60601-1-2 Company Name: Carilex Medical, Inc. Company Address: No. 77, Keji 1st Rd., Guishan Dist., Taoyuan City (333), Taiwan (ROC) Trade Name:...
  • Page 34 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop EMC Declaration Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and are specified for use only in a shielded location The Envelop_ Air Pump declaration – electromagnetic immunity The Envelop_ Air Pump system is intended for use in the electromagnetic environment specified below.
  • Page 35 Instructions for Use | Anti-Decubitus Air Enveloping Pressure Mattress System Envelop Safety Precautions for Li-Ion Battery Pack The safety precautions for Li-Ion battery pack are quoted from IEC 62133 Annex B & C. The following represents a typical, but non-...
  • Page 36 U-2S2003-30421-G V1.3 2019/02/01...