THE HEaD IMMOBIlIZEr
Contents
1. pressure water Read the user manual carefully This product meets European Union Standards O Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E Training Head Immobilizer 2 OPERATOR SKILLS AND TRAINING 2 1 Skills Operators using the head immobilizer need e specific experience of patient handling procedures e the ability to assist the patient 2 2 Training Operators need to e carefully read and understand the information in this manual e undergo adequate training in the use of the head immobilizer e practice with the head immobilizer before using it in an actual situation with a patient e record training sessions An example of the training session record form is shown on page 16 Untrained operators may injure themselves and or cause damage or injury Only trained qualified operators should be allowed to use the head immobilizer 365 E 3 THE HEAD IMMOBILIZER 3 1 Description The head immobilizer 365 E known simply as the head immobilizer in this manual is a device that immobilizes the head and neck of the patient The head immobilizer is designed to be used by a minimum of two trained and qualified operators A third operator may be required according to local protocols and an additional helper may be needed for heavy patients The head immobilizer has a base plate to support the head ensuring necessary protection from the ground as well as two support pads fas2. the Head Immobilizer 4 USING THE HEAD IMMOBILIZER 4 1 Before Using the Head Immobilizer Operators using the head immobilizer must have carefully read and understood the information in this manual Before any use of the head immobilizer ensure that the base plate support pads forehead and chin straps and H Velcro strap are present and ready for use Check that the head immobilizer has no sign of damage or wear and is working perfectly See nspection page 11 4 2 Instructions for Use This manual does not provide any medical advice It 1s responsibility of the users to ensure correct and safe practices for the patient and themselves This manual illustrates use of the head immobilizer in an ideal setting and should be considered as a guideline only A minimum of two trained and qualified operators are needed to use the head immobilizer Operators must work together and cooperate correctly during all operations Follow standard protocol procedures for emergency patient handling Operators must work together by communicating and cooperate correctly when using the head immobilizer During application of the head immobilizer one operator should manually stabilize the patient s head and neck while the other applies the head immobilizer The head immobilizer must always be used together with a cervical collar as it is not a substitute for the latter Always follow guidelines and local medical proto
3. 1 1 Warning 1 2 Important 1 3 Bloodborne Disease Notice 1 4 Compatibility 1 5 Symbol Glossary 2 Operator Skills and Training 2 Skills 2 2 Training 3 The Head Immobilizer 3 Description 3 2 CE Conformity 3 3 Components Head Immobilizer 3 4 General Technical Specifications 4 Using the Head Immobilizer 4 Before Using the Head Immobilizer 4 2 Instructions for use 4 3 Applying the Head Immobilizer 5 Maintenance 5 Routine maintenance 5 2 Disinfection 5 3 Cleaning 5 4 Inspection 5 5 Storage 6 Spare Parts 6 1 Head Immobilizer 365 E Spare Parts 6 2 Head Immobilizer 365 E Accessories O Ferno Washington Italia MU 037 D October 2013 O c Q NINN UAA NAN NaN d d dgedgegeRBrtoro v m mo x xg m WW WORN S amp S RS m OO Chapter Paragraph 7 Technical Support 7 Technical Support 8 Warranty 8 1 Warranty Conditions 8 2 Disclaimers 8 3 Warranty Requests 8 4 Complaints 8 5 Authorization for Returns Training Record Maintenance Record Page 13 13 14 14 14 15 15 15 16 17 Safety Information Head Immobilizer 365 E 1 SAFETY INFORMATION Read this User Manual carefully It is an integral part of the device and must always be readily available For your own personal safety and that of the patient please observe the following Before each use inspect the device carefully to ensure it is not worn damaged or malfunctioning See Inspection par
4. 2 applies the H Velcro strap Figure 7 to secure the head immobilizer to the scoop stretcher 8 Both operators ensure that they have completely immobilized the head and correctly secured the patient to the scoop stretcher before patient handling Figure 7 Applying the H Velcro strap Figure 8 Head immobilizer correctly applied with the H Velcro strap 10 Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E Maintenance 5 MAINTENANCE 5 1 Routine Maintenance The head immobilizer requires regular maintenance The table on the right shows the minimum maintenance schedule Keep a record of maintenance operations An example of maintenance record is shown on page 17 5 2 Disinfection Disinfect the entire surface of the head immobilizer with a neutral non abrasive disinfectant If necessary use a soft brush to remove organic liquids Suitable gloves are recommended during disinfection e g disposable gloves or household gloves 5 3 Cleaning Wash the head immobilizer with warm water and mild non abrasive neutral detergent Rinse with clean water Dry with a towel or allow to air dry Do not clean with high pressure water Suitable gloves are recommended during cleaning e g disposable gloves or household gloves Be extremely careful of Velcro fastenings when disinfecting and cleaning Ensure that they hold and work properly 5 4 Inspection To guarantee optimal use o
5. S _S_ Sie CH Users OFERNO Manual When It s Critical Head Immobilizer 365 E Read this manual carefully and retain it for future reference October 2013 Pub N MU 037 D Ferno Technical Support Customer relations and technical support are important aspects of each Ferno product Please have the product serial number available when calling and include it in all written communications For technical support questions contact Ferno Washington Italia s r l Telephone Freephone 800 501 711 Fax 39 051 686 15 08 E mail info ferno it Ferno Customer Relations For service or further information contact Customer Relations Ferno Washington Italia s r l MANUFACTURER Ferno Washington Italia s r l Via Benedetto Zallone 26 40066 Pieve di Cento BO ITALY Telephone Freephone 800 501 711 Telephone 39 051 686 00 28 Fax 39 051 686 15 08 Internet www ferno it USERS MANUAL To request additional free user manuals contact Ferno Washington Italia Customer Relations Head Immobilizer 365 E Disclaimer This manual contains general instructions for the use operation and care of this product These instructions do not cover all possible applications and operations Safe and proper use of this product is solely at the user s discretion Safety information 1s provided for the user and only ensures the minimum level necessary to avoid injury to operators and patients All other safety measures ta
6. agraph page 11 To avoid infection or bacterial contamination follow instructions in Disinfection and Cleaning page 11 1 1 Warning Warning notices indicate a potentially hazardous situation which if underestimated could result in accident damage or injury Untrained operators may injure themselves and or cause damage or injury Only trained qualified operators should be allowed to use the head immobilizer Improper use of the head immobilizer may cause damage or injury Use the head immobilizer as shown in this manual Unauthorized modifications may cause serious damage injury or unforeseen operative problems Do not modify or alter the head immobilizer in any way Any damage to the head immobilizer components or the whole system may affect its performance and safety Inspect the head immobilizer frequently and especially before and after each use Do not use the head immobilizer if it appears worn or damaged Unattended patients may injure themselves Never leave a patient in the head immobilizer unattended Always attend to the patient during rescue operations Untrained helpers may cause damage and or injury or hurt themselves Do not allow untrained helpers to prepare the head immobilizer Take the utmost care while using the head immobilizer and coordinating helpers Inadequate maintenance may cause serious damage or injury Carry out maintenance as described in this manual The use of improper or unauthorize
7. ar Are there any tears in the head immobilizer or is any of the internal material coming out Are the forehead and chin strap and the H Velcro strap in good condition with no cuts or frayed edges Does the Velcro work properly Does the Velcro show signs of wear Does the Velcro hold properly Head Immobilizer 365 E 5 5 Storage The head immobilizer should be cleaned and stored in a dry place indoors away from direct sunlight It should be stored as shown when not in use Figure 9 Figure 9 Storage O Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E Spare Parts Technical Support 6 SPARE PARTS Ferno supplies original approved parts for head immobilizer 365 E Always follow the instructions in this user manual For further product information contact Ferno Customer Relations page 2 6 1 Head Immobilizer 365 E Spare Parts Description Code Base Plate 25 0057 001 Support pads pair 25 0061 000 Forehead and chin straps 25 0062 000 H Velcro strap 25 0059 002 The use of improper or unauthorized devices may cause accidents damage or injury Use only devices approved and authorized by Ferno W Italia 6 2 Head Immobilizer 365 E Accessories Code 10 9900 005 Description Transport storage bag for head immobilizer 365 E 7 TECHNICAL SUPPORT 7 1 Technical Support For product technical support contact Ferno Washington Italia Technical Support Te
8. at do not derive from defects of conformity will only be accepted after they have been checked by specialized Ferno W Italia s r l staff 15 Head Immobilizer 365 E TRAINING RECORD Type of Training Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E MAINTENANCE RECORD Type of Maintenance Maintenance Technician N Ferno Washington Italia MU 037 D October 2013 18 Head Immobilizer 365 E Product user and maintenance manual needed for the safe operation efficiency and reliability of the product and to render warranty conditions valid October 2013 Pub N MU 037 D Ferno Washington Italia s r l Via Benedetto Zallone 26 40066 Pieve di Cento BO ITALY Telephone Freephone 800 501 711 Telephone 39 051 686 00 28 Fax 39 051 686 15 08 E mail info ferno it Internet www ferno it Ferno Washington Italia MU 037 D October 2013
9. cols Always attend to the patient and never leave him alone when using the head immobilizer Ferno Washington Italia MU 037 D October 2013 Improper use of the head immobilizer may cause damage or injury Use the head immobilizer 365 E as described in this manual Never leave a patient in the head immobilizer unattended Always attend to the patient during all rescue operations Read the user Two Trained manual carefully Operators Required Minimum The use of improper or unauthorized devices may cause accidents damage or injury Use only devices approved and authorized by Ferno W Italia Important When not in use place head immobilizer 365 E in a dry place indoors where it is protected from direct light in storage configuration Storage page 12 Using the Head Immobilizer Head Immobilizer 365 E 4 3 Applying the Head Immobilizer During application of the head immobilizer one operator should manually stabilize the patient s head and neck while the other applies the head immobilizer Before applying the head immobilizer ensure that the cervical collar has been correctly applied on the patient Figure 1 For use of the cervical collar consult the relative user manual Figure 1 Cervical Collar Applied HOW TO APPLY THE HEAD IMMOBILIZER It is recommended that two trained qualified operators are present 1 Operator 1 raises the patient s head slightly in order to create the space needed to posit
10. d devices may cause accidents damage or injury Use only devices approved and authorized by Ferno W Italia Repairs carried out by technicians not authorized by Ferno W Italia will render any type of warranty void and may make any operation involving the head immobilizer dangerous Non original parts and inadequate technical support may cause damage or injury Only use original Ferno parts and contact Ferno W Italia Technical Support 1 2 Important Boxes with the word Important contain important information on the use and maintenance of this device 1 3 Bloodborne Diseases Notice To reduce the risk of infective bloodborne diseases like HIV 1 or hepatitis scrupulously follow the disinfecting and cleaning instructions in this manual 1 4 Compatibility The head immobilizer 365 E can be used with the Ferno SCOOPEXLM stretcher It should be used with Ferno Wizloc cervical collar Use only Ferno approved and authorized accessories Any other combination is not compatible with the specifics and instructions in this manual Ferno Washington Italia will not be held responsible for injury to operators or third parties caused by improper use of head immobilizer 365 E 1 5 Symbol Glossary The symbols defined below appear in this user manual The head immobilizer and this manual both carry the CE marking x ae AR The head immobilizer requires at least two qualified operators e Do not clean with high
11. f the head immobilizer all components must be in good condition free from dirt residue and body fluids The head immobilizer must be inspected and disinfected after every use If not used it must be stored indoors in a dry place and be inspected at least once a month Equipment maintenance personnel should inspect the head immobilizer at regular intervals Carry out the checks listed on page 12 Do not use the head immobilizer if you see signs of wear or damage during inspection and contact Ferno Customer Relations immediately O Ferno Washington Italia MU 037 D October 2013 Maintenance Schedule Disinfection page 11 E Cleaning page 11 m Inspection page 11 m o 9 o 9 9 N lt Inadequate maintenance may cause serious damage or injury Carry out maintenance as described in this manual Important When not in use place head immobilizer 365 E in a dry place indoors where it is protected from direct light in storage configuration Storage page 12 Important DO NOT CLEAN WITH HIGH PRESSURE WATER Do not clean the head immobilizer with high pressure water Important Products containing phenol or iodine may damage the head immobilizer Do not use products containing phenol or iodine to clean disinfect the head immobilizer 11 Maintenance 12 INSPECTION CHECKLIST FOR THE HEAD IMMOBILIZER Are all head immobilizer components present Does the head immobilizer show signs of damage or we
12. ion the base plate of the head immobilizer Figure 2A Ensure that the patient s head is aligned during this operation 2 Operator 2 inserts the base plate of the head immobilizer under the patient s head Ensure that the base is centered correctly during this operation Figure 2B Figure 2 Applying the base plate 3 Operator 2 applies the support pads and fastens them to the Velcro on the base Figure 3A Ensure that the holes are aligned with the patient s pinnae Figure 3B The holes allow the patient to hear the operator and for the latter to examine the pinna Figure 3 Applying the support pads O Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E Using the Head Immobilizer 4 Operator 2 while operator 1 maintains control of the patient s head operator 2 applies both forehead and chin straps Figure 4A and 4B Figure 5 Head immobilizer applied correctly 5 Both operators once the head immobilizer has been correctly applied proceed to place the patient onto the scoop stretcher Figure 6 Figure 6 Placing the patient on the scoop stretcher Ferno Washington Italia MU 037 D October 2013 9 Using the Head Immobilizer Head Immobilizer 365 E 6 Both operators before completing the immobilization of the head ensure that the stretcher restraints have been correctly applied to the patient 7 Operator 2 while operator 1 maintains control of the patient s head operator
13. ken by the user should be within and under consideration of applicable regulations Operators must be trained before using this product Retain this manual for future reference Include the manual with the product in the event of transfer to a new user Additional free copies are available upon request from Ferno Washington Italia Customer Relations Proprietary Notice The information disclosed in this manual 1s the property of Ferno Washington Italia s r l Via Benedetto Zallone 26 40066 Pieve di Cento BO Ferno Washington Italia s r l reserves all patent rights proprietary design rights manufacturing rights reproduction use rights and sales use rights related to any article in this manual except to the extent that those rights are expressly granted to others or where not applicable to vendor proprietary parts This manual may not be reproduced in whole or part without the express authorization of Ferno Washington Italia s r l Limited Warranty Statement Ferno products are covered by a 24 month warranty against manufacturing defects For complete terms and conditions of the warranty and the limitations of liability and disclaimers consult the chapter Warranty page 14 O Copyright Ferno Washington Italia s r l All rights reserved O Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E TABLE OF CONTENTS Chapter Paragraph Ferno Technical Support Ferno Customer Relations 1 Safety information
14. l alloy elements electrical and mechanical apparatus and batteries External finishes gel coat resin paint powder coating decals ribbons lettering etc are guaranteed for 90 days Repairs are carried out by specialized technical staff at the Ferno Washington Italia s r l headquarters in Via Zallone 26 40066 Pieve di Cento BO or at the Customer s premises if approved by Ferno Washington Italia Customer Relations Technical support carried out at the Customer s premises must be approved and will include partial reimbursement of expenses sustained that will be documented upon request For info on the cost of technical support contact Ferno W Italia L L C Technical Support Department Repairs are guaranteed for 6 months from the date of completion This warranty applies only if the product is used according to the user manual supplied Improper or careless use will render this warranty void The warranty begins on the day on which the product is sent by Ferno W Italia s r l and does not cover delivery costs Ferno W Italia s r l is not responsible for damage in transport or for damage caused by improper use of the product Products that do not have the original Ferno trademark sold by Ferno W Italia s r l are covered by the product manufacturer s original warranty Ferno W Italia L L C will not extend a warranty beyond the product manufacturer s warranty period Ferno W Italia L L C will not be held responsib
15. le for products manufactured by others 14 The warranty will not apply in the case of failure to observe instructions for use wrong usage inappropriate use or handling repairs to the device by unauthorized personnel damage in transport due to improper packaging when returned by the user lack of maintenance failure to use original parts In cases not covered by the warranty Ferno W Italia will not be responsible for transport costs for sending and returning the product 8 2 Disclaimers If a product is defective Ferno W Italia s r l will repair or replace it or refund the cost price at its option Ferno W Italia L L C will not be responsible for refunding more than the cost of the product The buyer accepts these terms in lieu of all damages Ferno W Italia s r l does not make any other express or implicit guarantees nor does it make any guarantee as to the merchantability or suitability for particular ends of its product or the products of others In the case of infraction of the limited warranty legal procedures must be archived within a year of the date on which an infraction was or should have been discovered Ferno W Italia s r l reserves the right to cancel the warranty on products sold if labels or plates showing the manufacturer s trademark serial number or registration number have been erased or removed if the product has been altered or repaired or if work ha
16. lephone Freephone 800 501 711 Telephone 39 051 686 00 28 Fax 39 051 686 15 08 E mail info ferno it Internet www ferno it For information on the correct use of head immobilizer 365 E and to organize training courses on the correct use of the device contact Ferno Washington Italia Customer Relations Ferno Washington Italia MU 037 D October 2013 Non original parts and inadequate technical support may cause damage or injury Use only original Ferno parts and Ferno W Italia technical support modifications Unauthorized to the head immobilizer 365 E may cause serious damage injury or unforeseen operative problems Do not modify or alter the head immobilizer in any way 13 Warranty Head Immobilizer 365 E 8 WARRANTY 8 1 Warranty Conditions Ferno products are guaranteed free from manufacturing defects for 24 months from the date shown on the Ferno W Italia s r l delivery note Ferno Washington Italia parts have a 12 month warranty During the warranty period all parts with properly ascertained manufacturing defects will be repaired and or replaced not including labor costs or transfer transport and packaging costs The warranty does not cover consumables or components subject to wear associated with normal product use any parts typically subject to sliding or rolling friction ball bearings brushes lubricants tracks and belts etc parts potentially subject to oxidation or corrosion copper or meta
17. s been carried out without authorization by Ferno W Italia s r l or its personnel ifthe product has not been used according to the instructions supplied or for purposes other than that for which it was designed according to paragraph 8 1 Warranty Conditions Under no circumstances will Ferno W Italia s r l be held responsible for direct or indirect damage caused by use other than that described in the user manual and for which the product was designed Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E 8 3 Warranty Requests If you suspect that you have received a defective product contact Ferno Customer Relations immediately A representative will deal with your complaint Obtain authorization from Ferno Customer Relations before sending products to Ferno W Italia s r l 8 4 Complaints Any complaints must be communicated to the vendor or to Ferno W Italia L L C Customer Relations within 5 days of receipt of the product or discovery of the alleged defect Complaints or controversies regarding a single product do not exonerate the buyer from the obligation of receiving and paying for other products in the same order unless otherwise agreed with the seller O Ferno Washington Italia MU 037 D October 2013 Warranty 8 5 Authorization for Returns No product will be accepted without prior approval by Ferno W Italia s r l Products returned for commercial reasons 1 e for reasons th
18. tened to the base with Velcro two straps for the forehead and chin and an H Velcro strap for patient handling on the scoop stretcher 3 2 CE Conformity MEDICAL DEVICES DIRECTIVE Ferno products meet the requirements of European Directive 93 42 EEC concerning medical devices The head immobilizer belongs to Class I Ferno Washington Italia MU 037 D October 2013 HEAD IMMOBILIZER FEATURES e Base Plate 1 e Support pads 2 e Forehead and chin strap 2 e H Velcro strap 1 Improper use of the head immobilizer may cause damage or injury Use the head immobilizer 365 E as described in this manual The Head Immobilizer 3 3 Components Head Immobilizer Base Plate Forehead strap Chin strap FRONT VIEW 3 4 General Technical Specifications Ferno reserves the right to change specifications without notice For further information contact Ferno Customer Relations page 2 Material Head immobilizer vinyl coating Length 250 mm Width 300 mm Weight 0 620 kg Head Immobilizer 365 E Support pads 2 H Velcro strap USERS MANUAL To request additional free user manuals contact Ferno Washington Italia Customer Relations Untrained operators may injure themselves and or cause damage or injury Only trained qualified operators should be allowed to use the head immobilizer O Ferno Washington Italia MU 037 D October 2013 Head Immobilizer 365 E Using
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