Home

V4 Ceiling Lift TECHNICAL DOCUMENTATION

Contents

1. 4 2 2 Technical specifications of charger Charger input 100 240 Vac 50 60 Hz Charger output 27 Vdc 1 A max Charger clip on the rail Charging station clip on the rail See appendix 2 4 2 b for more details v BHR 18 S BHW Voyager Portable Technical File 4 2 3 Technical specifications of motors DC Motor vertical movement Manufacturer ELVI Type Fully enclosed no ventilation opening permanent magnet without gearbox Part 100 462 FC BHM Part number 400 14000 Rating 24 Vde 1 1A 110 Watts 4000 RPM 0 3 N m Overall dim 977mm x 131 5mm long without worm shaft Mounting Secured by screws and lockwasher to chassis A Rotor Laminated steel 55 mm dia by 38 mm high Mounting Crimp to the shaft B Rotor Winding Enamelled copper wire class H UL see enclosed sheet C Rotor to winding insulation 1 layer of Isotherm 0 25 mm thick Class F 145 C D Spacer material PSU 2010 see enclosed sheet F Collector Copper 23 diam long see enclosed sheet G Brush Carbon composition mounted on spring Dimensions 5x8x12mm H Brush holder Later 4 G 30 see enclosed sheet 1 Motor leads Certified TEW 105 C N 18AWG connected by certified 2 pins AMP connector J Motor leads connection to windings crimping DC Motor horizontal movement Manufacturer ELVI Type Fully enclosed no ventilation opening permanent magnet with integral reducer Part 101 663 FC BHM Pa
2. Risk Analysis Table Danger source identification Risk evaluation Risk Corrective mesure revaluation 2 8 2 8 Elis Els 312 dE Situationirisk Dangerous Possible damage 8 2 5 lt Correction measurement 2 0 5 o phenomene 9 e gt zi si E OPE 513 5 2 8 8 8 8 Ola Ola Lifting internal mecanism Inertial emergency brake failure EN 3 as on the sling s drum Ska Co m Defective circuit Throttling 9 1 1 11 Emergency stop device 1 1 1 3 Defective circuit Fire burn GENEE EEN 4 Defective circuit Mechanical fail see 1 Advertising low battery 7 device manual lowering 1 1 0 2 device Preventive maintenance Sling failure Patient fall 91510114 storage procedure 91110 10 manual Defective circuit or battery Discomfort of the patient 115 Supply suspended in the airs Device sales without handset or buttons failure Disconfort of the patient 115 7 Manual lowering device 1 1 0 2 Unhooking of the fabric at the Addition claplets of safety time of the patient deposit exit Patient fall 9 5 0 14 on the arms advertising 9 1 O0 10 of the arm in the manual Fixing of the fabric on the Modification of the clapet S locket if the locket is outwards encata Se adverstising in the manual 3 10110 Patient crushing Wounds 1151016 No load detector device 1 1 d 11 Battery acid emanation Burn turbid respi
3. 6 Diodes D1 D4 D5 Accepted Manufacturer FAIRCHILD SEMICONDUCTOR Model 1N4007 Type Axial DO 41 Rating Aig 700 Vac PRY IUQUV Mounting Securely soldered to pc board 7 Capacitar C1 Accepted Manufacturer DAEWOO or Panasonic or Mallory id Model 22 ECAZVHG220 5K220M350ST SEK220M350ST Tyne Electrolytic Ratings 22uFd 350Vde 105 C M Mountings Securely soldered to po board 8 Inductance TZ2y Accepted Manufacturer ATC Frost Model 56575 FFT209 Type Vertically mounted Rating 27mH 0 4A Mounting Securely soldered to po board 9 Capacitor C2 Certified CSA UR Manufacturer STK Nichicon Model MM35D1004K00 QXJ2GI03K TP Type Metallized Polyester Film Capacitor PEMR series Ratings luFa 4o0Vde Mountings Securely soldered to po board 10 Capacitor C3y Accepted Manufacrurer Pr Cap Model MAI206CGJ222 Type Ceramic Chip Ratinps 2 2 nF S0V v Mountings Securely soldered to po board 1329600 2 ad BEIS 56 IMEIHCAL INC BHM Y cum Voyager Portable Technical File 03 07 03 JEU 14 48 FAX 18198652219 BHM MEDICAL INC MASTER CONTRACT REPORT 1322600 PROJECT 1329600 184445 11 Transistor Qd Accepted Manufacturer Zetex Model FMMT458 Type NPN Ratings lc 225 mA Voe 400V Veb 400V Mountings Securely soldered to po busud 12 1 Zener diode D7 Accepted Manufacturer Fairchild Semiconductor Model 1N5240B Ratings Vz 10V z 20mA Po 500m
4. Bottom openinge none Refer to photographs for morc details 2 Power Supply Cord Set Certified CSA Manufacturer Wellshin Model W8004 Type SPT 2 Attachment Plug Type 1 15P moulded on attachment plug cap at one end Main power Cord No 18 2 AWG FT2 VW 1 End Plug Type LEC 320 C7 female connector body at other end terminates in a moulded on Ratings 2 5A Q 125Vac Mounting Inserted into maie IEC320 coupler which is securely maintained on enclosure 3 AC Input Appliance Coupler Inlet Certified CSA UR VDE S N Manufacturer Schurter Model No 4300 0097 Type Class I 2 pin Rating 2 5A 250Vac Mounting Secured soldered to pe board and retained by plastic enclosure NS 13296001 Vad I t Elali 55 Y IMEIHCAL INC BHR Voyager Portable Technical File Y 02707 03 JEU 14 45 Faz 13199652249 BHM MEDICAL IRC i012 MASTER CONTRACT 184445 REPORT 1529600 Page No 12 PROJECT 1329600 Date Issued October 4 2002 4 Fuse Main Input Certified cA RARA DF S F Manufactuer Wickrnaun Madel 1100 Series 181 or 195 Type Type T Glass or ceramic cartridge 5 min x 20 mm Rating 1A 250 V ac Mounting Inserted into the metal fuseholder requires a tool to replace 5 PC Board Accepted Manufacturer BHM Type Epoxy Wafer multi layer Model 492 00031 Flammability Rating V O ot 1 5 mm min Dimensions 102x87 mm by 1 5 mm thick Mountings Mounted on spacers and securely mounted to encloswe by the means of clips
5. Reusable surgical instruments in which case they are in Class I Intended to supply energy in the form of ionizing radiation in which case they are in Class llb Intended to have a biological effect or to he wholly or mainly absorbed in which case they are in Class IIb v lalala 25 S BHM Voyager Portable Technical File Intended to administer medicines by means of a delivery system if this is done in a manner that is potentially hazardous taking account of the mode of application in which they are in Class IIb 2 3 All surgically invasive devices intended for short term use are in Class Ia unless they are intended Either specifically to diagnose monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body in which case they are in Class HI Or specifically for use in direct contact with the central nervous system in which case they are in Class III Orto supply energy in the form of ionizing radiation in which case they are in Class Ibis Orto have a biological effect or to be wholly or mainly absorbed in which cast they are in Class HI Or to undergo chemical change in the body except if the devices are placed in the teeth or to administer medicines in which case they are in Class IIb Non invasive 2 4 All implantable devices and long term surgically invasive devices are in Class IIb un
6. 353 1 67 67 836 O Connor www imb ie Earlsford Centre Ealsfort Terrace Dublin 2 Ireland ICELAND Ministry of Mrs vilborg landlaek Laugavegur 116 Ph 35 45 609 700 Health and Social Vilborg nir IS 150 Reykjavik Service Ingolfsdottir Fax 35 45 519 165 ITALY Ministry of Dr M Nihil Dipartimento II Ph 39 6 59 94 2423 Health Marletta Piazza Industria 20 1 00144 ROMA Fax 39 6 59 94 2111 IVD Dr Mirella Nihil Dipartimento per Ph 39 06 59 94 37 22 Colella la Valutazione dei Medicinali Fax 439 6 59 94 32 85 Farmacovigilanza Ufficio IX Via della Civilt Romana 7 1 00144 Roma LUXEMBOURG Dr G gerard scharll m villa Louvigny Ph 4 352 478 56 34 Minist re Scharll s etat lu All e Marconi de la Sant L 2120 Fax 352 262 03296 Direction Luxembourg de la Sant NETHERLANDS MDD Mr J medtech higz ig Cluster Medical Ph 31 70 340 74 36 Health Care Moleveld z nl Technology PO Inspectorate IVD Box 16119 Fax 431 70 340 71 59 NL 2500 BC Den Haag NORWAY Mrs ingeborg hagerup PO Box 8054 Ph 47 24 16 31 76 Norwegian Hagerup Dep Directorate for Health Jenssen jenssen shdir no Fax 47 24 16 30 21 and Social Welfare N 0031 Oslo Mrs Tove tove farstad shdi Ph 47 24 16 31 72 Farstad r no Fax 47 24 16 30 21 IVD Mrs S sissel dyrnes sh Ph 47 24 17 31 67 Dyrnes dir no Fax 47 24 16 30 21 PORTUGAL MDD Mr Miguel miguel antunes i Parque de Sa de Ph 351 21 798 71 79 Direc o IVD Antunes nfarmed pt de Lisboa
7. Clip on charger any where on the track 120 240 Vac 50 60 Hz 27 Va Class 2 insulated CSA no 601 1 and UL No 2601 1 certifications CE marked Respects EMI standards electromagnetic interference 158010535 HANDSET ABS fire retardant Santopren tactile buttons P44 Infrared remote control optional 2001 Tanguay St Magog Quebec Canada J1X 5Y5 1 800 868 0441 Fax 819 868 2249 www bhm medical com BEIS wy METHCAL INC V the next generation in ceiling mounted patient lifts charger power supply emm D s station hit status LED s auxiliary emergency liL controls slop curd carry bar 80 PHM Voyager Portable Technical File Y ema designed for use with the revolutionary new track system a configuration to suit every need easier amp faster to install a system of components e aesthetically pleasing reduces space required for curves by 1 3 ideally suited for use in confined areas uses the patented KWIKtrak bracket the V4 amp KWIKtrak system at work 1 X layout in the ICU 2 in a physical therapy facility 3 down the hallway for gait training 4 branched layout with track exchanger 6 6 private room installation ina semi private room 4 WwW BHM 2001 Tanguay St Magog Quehec Canada J1X 5Y5 1 800 868 0441 Fax 819 858 2249 bhm medical com BEIS W corm 81 BEIRA P Voyager Portable Te
8. DO NOT forcibly bend the power cord or place a heavy object on it This will damage the cord and may cause fire or electrical shock DO NOT pour liquid on or near the charger Do not place the unit in locations that are N e Extremely hot e Dusty or dirty e Very humid e Moving or vibrating N DO NOT SLIDE THE LIFT TO THE CHARGER FORCEFULLY OR QUICKLY CHARGER MAY BECOME DAMAGED Whenever possible leave the lift on the charger when the lift is not in use At minimum charge the battery until the light is green before using it again This will extend the life of the battery Maintenance ALWAYS CARRY OUT THE DAILY CHECKLIST BEFORE EACH LIFT USE Alterations made to the V4 by someone other than a certified technician may cause serious injury and voids the warranty The V4 and accessories must be inspected ANNUALLY by a certified technician in addition to the daily and other periodic visual checks done by the user specified in this section Preventive maintenance specified in this manual can prevent accidents and reduce repair costs v BHM 76 Voyager Portable Technical File e BHW Note all services or repairs to the V4 or its accessories in the log book at the end of this manual Have the document signed by the certified technician Do not immerse lift in watter N Always reinstall the rail end stopper if it has been removed
9. EK H BEIS 51 IMEIHCAL INC BHR Voyager Portable Technical File 03707 03 JEU 14 43 FAX 18108852240 BHM MEDICAL INC 14008 MASTER CONTRACT 184445 REPORT 1329600 Page No 8 PROJECT 1329600 Date Issued October 4 2002 7 PCB Connector Ja Cerufed UR LN 1 Manufacturer AMT Cat N 35 764 4 1 ARAT S 0 Rating 304 240 Vac Mounting Soldered to peb Relay K1 A K2 A K3 A K4 A INT Cerified CSA UR TUV Manufacturer Hasco Type Encloscd SPDT Cat N KTTICIASDCI2 Raliuy Cuil 12Vde Contacts 28V do 104 Mounting Soldered to peh 9 Motor Drive Transistors Q9 and Q10 INT Manufacturer International Rectifier Type Silicon plastic body TO 220AB case Cat N TRI ZAAN Ruling 60V SOA Mounting Soldered to pcb and secured to 35 x 25 x 13 mm alurminum heat sink 10 Internal Wiring INT Certified CSA UL Type TEW 105 C 16 or 18A WG H Switch 53 56 Certified INT V Manufacturer Omron Type Tactile Switch Cat N B35 1002 Rating 50mA 24Vde 12 Emergency Switch 5 Certified CEA UR Manufacturer Zingear SPC Type Pullchain switch Cat N ZE 100 16N902 Rating 125 250Vac 6 5A 13 DC Motor vertical movement Accepted Manufacturer ELVI MOTORI ELETTRICI SRL Type Fully enclosed no ventilation opening permanent magnet class A Cat N 100 462 FC D IM Part number 400 14000 Rating 24 Vde 1 14 110 Watts 4000 RPM O 3 N m Overall Dimensions 677m
10. APPLICABLE REQUIREMENTS ds CAN CSA C22 2 No 0 M91 General Requirements Canadian Electrical Code Part 11 CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part I General Requirements for Safety CAN CSA C22 2 No 601 181 94 Supplement No 1 94 to CAN CSA C22 2 No m 601 1 M90 Medical Electrical Equipment Part 1 CS General Requirements for Safety CAN CSA C22 2 No 601 1 1998 Amendment 2 to CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part I General Requirements for Safety IEC Standards IEC 60601 1 1988 Medical Electrical Equipment Part 1 Gencral Requirements for Safety TEC 60601 1 1991 Amendment No 1 1991 Amendment 1 to 60601 1 1988 IEC 60601 1 1995 Amendment No 2 1995 Amendment 2 to 60601 1 1988 UL Standard No 2601 1 97 2 Edition Medical Electrical Equipment Part I General Requirements for Safety Subject to the following conditions 1 The equipment has not been investigated for the protection against hazards of explosions in medically used rooms 2 Units provided with other than CSA Certified power supply cord sets are Certified without the power supply cord set as components only 3 Evaluated to IEC CSA 601 1 Amendment 2 excluding requirements for Biocompatibility Clause 48 and Programmable Electronic Systems IEC 60601 1 4 referenced in sub clause 52 1 DOD 07WD 2 02 04 30 EEN G b EZ Drim 44 v PHM Voyager Portable Technical File Y coum d E x CSA INTE
11. Distributes the weight evenly throughout the sling covers a wide area of the back for support reduces pressure under the arms gt Strong nylon straps with Adjustable straps allows for patients with a large midsection positioning loops provides flexibility for many types of patients gt 400 lbs lifting capacity Very strong and durable ensure patient safety gt Machine washable Easy to clean and care for gt S M L XL Sizes Medium fits most patients small sizes fit most paediatric patients large fits tall or very stocky patient ERE 99 BEIRA Voyager Portable Technical File DE OD WV cua THE SOFT STRETCHER SLING Y Frame A5515 The soft stretcher sling was designed to make prone transfers simple and efficient The sling itself is made from a polyester nylon net material that is pliable breathable Product and easy to use Eight sturdy straps support the length of Sling TOC L the body and connect to specialized frame for the soft TOC M stretcher Because the frame is attached to the lift and not the sling it is faster and easier to install The straps also ensure the patient safety by ensuring the person cannot fall out of the sling Fits to Voyager Series ceiling lifts and the Ergolift mobile lift SLING DIMENSIONS SOFT STRETCHER SLING PRODUCT TOC v BH IN 100 BHR F Voyager Portable Technical File
12. Dupont Rynite TR 530 Insulation Clase B 130 C VO PET 1325600 13 ad BEIS Bi IMEIHCAL INC 57 BHR Voyager Portable Technical File Y 03 07 03 JEL 14 48 FAX 18198652219 BHM MEDICAL INC 141014 MASTER CONTRACT 184445 REPORT 1329600 Page No 14 PROJECT 1329690 Date Tssued October 4 2002 Material Primary to core a Under winding Polyester tape 130 C 0 457 mm h Flange Polyester tape 130 C 0 457 mm 2 layers c Core window cuterwrap Glass Cloth Tape 130 C 0 063 mm layer Primary to secondary Polyester tape 130 C 0 063 ram 2 layers Crossover Insulation Polyester tape 130 C 0 457 mm 2 layers Margin Tape Polyester tape 130 C 0 457 mm 2 layers Imprepnation Compound Any dry varnish or equivalent Temperature rating 180 C Class II Thoqmal protection None 16 Digde D9 D10 D11 Accepted Manufacturer Fairchild Semieondnetar Mudel 1N4935 Type Fast Recovery Ralings 1A 2250V Po 2 5W Mountings securely soldered to pe board 17 Diode D13 Accepted Manufacturer Fairchild Semiconductor Model 1N5401 Type General Purpose Ratings SAMI 0OV l o 6 25W Mountings securely soldered to pe board 18 Capacitor C12 Accepted Manufacturer Phillips Model SME63VB471M12X25LL Type Electrolytic Ratings 470uFd 63Vde 85 C M Mountings Securely soldered to pc board 19 Inverter Circuits Accepted Manufacturer Philips Model HEF4069UB Type LC Six inverter circu
13. Each finished Voyager Portable is individually tested in our laboratory Lifting Capacity 200 kg 440 Ibs Engineering safety factor exceeds European Standards using medical quality materials and fabrics ISO 9001 e Voyager is a registered trademark of BHM Medical Inc APPROVALS CSA 601 1 UL 2601 1 EN 60601 1 US 5 1 Test records 5 1 1 Internal laboratory and engineering tests Internal conception and development information are available 5 1 2 Records methods and tests localization See section 2 for certificates and reports v GI Complete range of patient lift slings and supports designed and manufactured by BHM Medical Inc 21 lt gt BHW Voyager Portable Technical File Appendix 2 1 2 Directive 93 42 EEC Annex VII Directive 93 42 CEE Concerning Medical Devices June 1994 Annex VII Declaration of Conformity Product V4 Clause Requirement Notes Verdict 2 The manufacturer must prepare the technical documentation described in Section 3 The manufacturer or his authorized representative established in the Community must make this documentation including the declaration of conformity available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured Yes The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive It must include i
14. FRAME 66 26 63 25 49 19 CHARACTERISTICS BENEFITS gt Soft Polyester Nylon upper Specially designed fabric is ultra soft and long lasting fabric is easy to move easy to install in bed gt Soft Padded leg area Provides additional support and strength to the buttocks and leg area Padding protects the tender skin gt Strong Nylon straps with Patient position can be adjusted slightly depending on need positioning loops provides flexibility for comfort gt Extra Sturdy Excellent for heavy patients extra room for thighs and hips Eli 106 E Voyager Portable Technical File wy gt Positioning Handles Positions patient properly in a chair no manual positioning needed provides a safe way for caregiver turn the patient gt White powder coated steel Strong and durable Umbrella shape with 4 hooks provides ample frame room for the patient gt 455 kg 1000 lbs lifting Very strong and durable ensures patient safety capacity Machine washable Easy to clean and care for gt One XXL Size Fits most bar iatric patients TOB SLING MUST BE USED ONLY WITH SPECIAL CARRY BAR v GE 107 eru lt gt BHM Voyager Portable Technical File QUICK STEP STAND AID Product 96500 Sling SMALL MEDIUM LARGE 96600 96610 96620 Quick Step provides weight bearing transfers for patients residents with the Ergol
15. Ph 351 21 798 71 51 Operacional de Av do Brasil 53 Ph 351 21 798 71 45 Farmacogivil ncia e adriana gamboa Seguran a de infarmed pt Pav 241749 Fax 351 21 798 71 55 Medicamentos e 004 Lisboa Produtos de Saude dvps infarmed pt do INFARMED Instituto Nacional de AIMD Dr Jo o Nihil Av Padre Cruz Ph 351 21 751 92 00 Sa de INSA Dr Lavinha P 1649 016 Ricardo Jorge Lisboa Codex Fax 351 21 752 64 00 v GE 70 Medical Devices Agency aic doh gsi gov uk Center Hannibal House Elephant and Castle UK London GEI 6TQ BEIRA P Voyager Portable Technical File WE com SPAIN Ministerio de Mrs C cabad 2msc es Direcci n General Ph 34 91 596 43 48 Sanidad y Consumo Abad Luna de Farmacia y cvalls msc es Productos Fax 34 91 596 44 00 Mrs C Sanitarios Valls WWW msc es Paseo del Prado Ph 34 91 596 43 48 18 20 E 28014 Madrid Fax 434 91 596 44 00 SWEDEN MPA AIMD MrLennart www sos se Box 26 Ph 446 18 17 46 00 Medical Products MDD Philipson lennart philipson Agency IVD mpa se SE 751 03 Fax 46 18 50 31 15 Medical Devices Mr Lars lars johansson UPPSALA Johansson mpa se SWITZERLAND Mr A Sparti medical devices Medical Devices Ph 41 31 323 22 51 Swissmedic Swiss swissmedic ch Division Agency Erlachstrasse 8 Fax 41 31 322 76 46 For Therapeutic CH 3000 Bern 9 Products UNITED KINGDOM Mr A Sant mb mda Adverse Incident Ph 44 171 972
16. Replace any precautionary or instruction labels that cannot be easily read Avoid violent shock during transportation SHOCK PREVENTION DO NOT touch or use a lift with bare conductors or a damaged power cord Electrically live equipment can electrocute a patient If hte lift or charger has any exposed or damaged wires contact your local dealer immediately DO NOT splash or expose electric parts of the device to water or moisture CHECK nameplate for voltage and cycle requirements These requirements differ by country Do not attempt to use the lift in an area that has a different voltage and cycle requirement DO NOT attempt to expose service or repair the lift battery or charger If any unit is malfunctioning contact your local dealer READ batteries and charger instructions thoroughly before using or storing them FIRE AND EXPLOSION PREVENTION Batteries may explode leak and cause personal injury if no disposed of properly e Do not place or store the battery under direct sunlight or near a heat source e Do not dispose of in fire e Do not short the battery terminals e Flush with water if electrolyte Acid comes in contact with skin or eyes wv lalala 74 BEIRA e Voyager Portable Technical File Sicht com gt Batteries must be recycled disposed of according to local law regulations When returning batteries insulate their terminals with adhesive tape etc Otherwise the residual electricity in u
17. after servicing Strap If there is any sign of wear as indicated here or other visual defects strap should be changed immediately By continuing to use the lift without changing the strap caregiver and patient safety is greatly compromised In any case the manufacturer recommends changing the strap at leat every two years By continuing to use the lift without changing the strap caregiver and patient safety is greatly compromised Take note of inspection results in the logbook at the end of this manual Handling and storage BHM Medical recommends charging of batteries at least every two weeks even if the lift is not used This will prevent premature ageing of batteries DO NOT ATTEMPT TO USE A BATTERY NOT AUTHORIZED BY BHM MEDICAL BHM batteries are specially designed for BHM charging systems Attempting to use an unauthorized battery may seriously damage the lift and or the charger V4 AND ACCESSORIES MUST BE SERVICED EVERY 12 MONTHS AS A MINIMUM REQUIREMENT Do not attempt to do the inspectionunless you are certified to do so As part of the annual inspection an anual load test with the safe working load must be performed on the V4 as required for CE MARK MAINTENANCE After annual inspection have the logbook signed by the certified technician v Ely 77 BERT Voyager Portable Technical File Y cer V App
18. flashes when servicing is required contact customer service The button Programming mode allows you to modify the functions of the product 3 1 3 Dimensions In millimetres BEIS W corm 10 V4 serie Technical file v BEERA 3 r CEILING TT e TOTAL 17 O S MEIHNCAL INC BEIRA Voyager Portable Technical File Xr WV cua 3 1 4 3 1 7 Definition of product family Family Voyager Ceiling Lift Voyager BHM serial name trade mark Lift Equipment for transferring by lifting and moving a disabled person in an area limited by the system Ceiling Stationary hoists using a ceiling support a ceiling rail or a freestanding support Functional purpose of the device intended use Lifting and moving a disabled person Variants of the device Voyager 420PLUS or V420PLUS Name The trade name Voyager VA20PLUS or V420PLUS is used in some parts of North America The major difference is the safe working load indicated on V420PLUS is 190kg 420lbs for reason commercial only Conception and fabrication All Voyager 420PLUS have the same conception and fabrication for mechanism and control than V4 The most frequent variation is optional features and cabin Records of significant changes to the device design No major modification was made to the product None are concerning critical safety or subjected part to the standards 3 2 Use information 3 2 1 3 2 2 3 2 3 Adv
19. pressure temperature or variations in pressure and acceleration The risks of reciprocal interference with other devices normally used in the investigations or for the treatment given The risks arising where maintenance or calibration are not possible as with implants from ageing of materials used or loss of accuracy of any measuring or control mechanism Requireme nts of EN 1441 Risks analysis applied Yes Yes N A Yes 9 3 Devices must be designed and manufactured in such a way as to Yes Y E Schi CENA Voyager Portable Technical File 29 S BHW minimize the risks of fire or explosion during normal use and in single fault condition Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion 4 Terminals and connectors to the electricity gas or hydraulic 10 Devices with a measuring function N A 11 Protection against radiation N A 12 Requirements for medical devices connected to or equipped with an energy source 12 1 Devices incorporating electronic programmable systems must be Requireme Yes designed to ensure the repeatability reliability and performance of nts of EN these systems according to the intended use In the event of a 1441 Risks single fault condition in the system appropriate means should be analysis adopted to eliminat
20. serial number N A m Where applicable method of sterilization N A 13 4 If the intended purpose of the device is not obvious to the user the See labels Yes manufacturer must clearly state it on the label and in the and instructions for use manuals 13 5 Wherever reasonable and practicable the devices and detachable Yes components must be identified where appropriate in terms of batches to allow all appropriate action to detect any potential risk posed by the devices and detachable components 13 6 Where appropriate the instructions for use must contain the following particulars a The details referred to in Section 13 3 with the exception of d and c Yes b The performances referred to in Section 3 and any undesirable side effects Yes c If the device must he installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination N A d All the information needed to verify whether the device is properly installed and can operate correctly and safely plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times Yes e Where appropriate information to avoid certain risks in connection with implantation of the device N A f Information regarding the risks of r
21. 5 117 181 cm 6 Colour Code Red Yellow Green Hammock Product THA S THA M THA L Hammock 6Product THA6 S THA6 M THA6 L Sling Attachment Options Option 1 Option2 Option 3 OPTION 1 Bridge Most recommended OPTION 2 Leg Separation Using this method of sling placement will pull the patient s legs apart Check with the patient s physician nurse or medical specialist before attempting this method OPTION 3 Amputee AN Do not use this method of sling placement for a patient who is agitated or spastic Sling attachment to Carry Bar Eli 90 Voyager Portable Technical File Use the same colour loop on the leg straps for both sides of the sling Use the same colour loop on the hip straps for both sides of the Hammock 6 strap sling Always use the same colour loop on the rear shoulder straps for both sides of the sling CHARACTERISTICS BENEFITS gt Soft Polyester Nylon net Specially designed fabric is ultra soft and long lasting dries quickly excellent for bath transfers gently hugs the patient fabric is easy to move easy to install in bed gt Ultra smooth Polyester leg Easy to install on a seated patient patient never has to sit on area the sling slides without irritation to the patient s skin gt Strong Nylon straps With Patient can be seated semi reclined and fully reclined provides
22. 60601 1 4 referenced in sub clause 52 1 NA 1220600 2 0d Eb MIR BEID 47 wy MEINCAL INC BHR Voyager Portable Technical File 01 07 03 JEU 14 41 FAX 18198852219 BHM MEDICAL INC dana MASTER CONTRACT 184445 REPORT 1329600 Page No 4 PROTECT 1329600 Date Issued October 4 2002 D ACCOMPANYING DOCUMENTS An operating manual is provided that specifies proper operating procedures for the equipment recommended accessories proper cleaning and operator maintenance procedures maintenance information amd particular technical characteristics For UL 2601 1 Multiple voltage cord connected equipment shall be provided with instructions to indicate the type of attachment plug that should be used for connection to the alternate voltage SPECIAL ADVICE FOR FIELD REPRESENTATIVES a Markings as above shall appear on each unit b The operator s manual shall contain instructions for replacement of parts subject to deterioration c Insulated conductors of the primary circuit and safery extra low voltage circuits shall be secured and separated d There shall be no indicaror lights that are red in color except to indicate a warning of danger or need for urgent action e The shipping package shall be marked with the allowable transport and storage environmental canditions such as humidity range atmospheric pressure range and temperature range This sliall also be listed in o the manual Temperature Operating 10 ta 40 Storage
23. Inc ASGS SGS Services de Certification Internationale Canada Inc Certificate Number Num ro de certificat 2418 00 This is to certify that the Quality Management System of Le pr sent certifie que le syst me de gestion de la qualit de BHM Medical inc 2001 Tanguay Magog Qu bec J1X 5Y5 Has been assessed and registered as meeting the requirements of ISO 9001 1994 The scope of registration is as follows A t valu et enregistr conform ment la norme ISO 9001 1994 Le domaine d enregistrement est pr sent ci dessous Design production sales installation and servicing of mobile patient transfer motorized ceiling lifts and related accessories Conception production ventes installation et service de l ve personne levier sur rail et accessoires connexes Signed for and on behalf of SGS International Certification Services Canada Inc Document sign pour et au nom de SAS Services de Certification Internationale Canada Inc December 5 2000 le 5 decembre 2000 This certificate remains valid subject to maintenance of the system Certificat valide sous r serve du maintien satisfaisant du syst me SGS International Certification Services Canada Inc SGS Services de Certification Internationale Canada Inc Unit 2 6275 Northam Drive Mississauga Ontario Canada L4V 1Y8 certificate remains the property of SGS ICS to whom it must be retumed upon Ce document n est pas l gal et ne peut tre
24. LE ML ai Maddy SPECO EAMA fyleducen tie Y pr 65 SEIN CSC Y Voyager Portable Technical File SBHM 02 07 03 JEU 11 50 FAX 18193652219 BHM MEDICAL INC 14022 1 DE 2 FEJILEE TITRE ve MAINSHELL ZRECK TOUTE Les ABS FR vo L FOI NF SURFACE Y CHELLE NON 19 zt 5 812 200 514 87 ema 807 31 y VOLUME ABS FR 2000 BLANG FWH010639 MASSE BAYER PLASTICS DIVISION 202 14 1C REV Oda NOTE Lis Teer ASA Bw loc caline epp ROIECT 12228 Mechanical Denying 3 GE 66 Y comm 15023 Voyager Portable Technical File BHM MEDICAL INC 50 FAX 18198652219 03 JEU 14 01 07 HIRT 4 R Y DESP 00 VE zem Dre ENLAZA ww mm 53 Belg dah 355v L SG L NNA en mn sima ES gg BSE 28 ELSE O0ZSWNNOW SHY eg er NV LG SIEL NOISSTYCHIA ALNYNG cs m x 38 2607 SEBO ETTA eee HOLVN 407100 TER 15H23 AUS HON SOCIAL 3 0N DA HA SAY aunidaAno La GNO 23A 3199 NA 3NI3 Id 3H93714 HLNIO G ANS adl 342312 381304 H23713 gt HONWI8 3HON3 nini mad NI OVA 334 NOYL 67 at iech mt tee Sa niea Ltr A Pewee SH TOP EK pa em im DO PCIE ETT Lilet MEINCAL INC gt Y BA a Voyager Portable Technical File AAA Y MEDICAL INC Appendix 2 6 SGS Certificate ISO 9001 1994 7 SGS International Certification Services Canada
25. Recognized and appropriately sized for the gauge of conductors used vinyl maulated optional for grounding idivd min 9OBC 250V ac Connectors All connectors used in pri and SEC circuits are certified UL Recognized and appropriately sized for the number and gauge of conductors used rated min 250V ac Printed Wiring Boards PWE All pwb a arc OL Recognized and arc made of paper phenolic paper cpoxy or glass epoxy min 1 6 mm thick flammability rated 94V or better Bonding All accessible metal parts liable to become energized are acceptably connected together and to the grounding means by straps and or conductors bolts screws and starwashers to ensure surface coating penetration Paint is masked in conformance to Clause 3 4 of CSA Standard C22 2 No 04 1329600 6 ad BEID 50 wy MEINCAL INC BHR Voyager Portable Technical File Se Y core Y 03 07 03 JEU 14 43 FAX 19199852249 BHM MEDICAL INC 14007 MASTER CUNTRACT 184445 REPORT 1329600 Page No 7 PROJECT 1329600 Date Issued October 4 2002 DESCRIPTION PART A The only difference between models is that V420 PLUS is limited electronically to lift 420 lbs and model Y4 is limited electronically to lift 600lbs Each model consiste of a 24V de battery or electrically operated patient lifter module installed on a rail All components are enclosed in non combustible enclosure without ventilation opening Lifter can be displeced manually or it is moved b
26. above coupling components within the product may require the tests he conducted using DC voltages Where DC voltages are used the test values arc increased by 1 414 times tlic AC voltages The test period may he shortened by nsing a potential 20 percent higher for one second Transformers Connected to AC Supply Each transformer before assembly into the equipment shall be subjected to the following dielectric strength tests for a period of one minute without breakdown An AC potential applied between each winding and the core and metal enclosure with all other windings grounded to the core and metal enclosure The test potential shall be a For Primary Windings lo Core 1500 Y ac b For Primary Windings to SELV Secondary Windings 4000 V ac c For Secondary Windines to Core 1000 V ac The test period may be shortened hy using a potential 20 percent higher for ane second Transformer manulaclurers written agrostuenl to conduct transforiner dielectric strength test on 100 percent production will be acceptable The power supplies employed in the subject equipment are CSA Ceryfied UL Recognized Therefore the system componen and power supply manufacturer is responsible for production line dielectrio voltage withstand tests on power supply isolating transformers For this reason such tests for the final product have been waived 2 LEAKAGE CURRENT Measurement of the earth leakage current according to CAN CSA C22 2 No 601 1 Cl 19 and F
27. acceleration thermal ignition sources etc N A m Adequate information regarding the medicinal product or products which the device in question is designed to administer including any limitations in the choice of substances to be delivered N A n Precautions to be taken against any special unusual risks related to the disposal of the device N A o Medicinal substances incorporated into the device as an integral part in accordance with Section 7 4 N A p Degree of accuracy claimed for devices with a measuring function N A 14 Where conformity with the essential requirements must be based on N A clinical data as in Section I 6 such data must be established in accordance with Annex X This text don t reproduce the directive but to refer at this v Elali 33 S BHW Voyager Portable Technical File Appendix 2 2 2 Directive 73 23 EEC Directive 73 23 EEC Electrical Equipment Voltage Limits February 1973 Annex Principal Elements of the Safety Objectives for Electrical Equipment Designed for Use Within Certain Voltage Limits Product V4 Clause Requirements Notes Verdict 1 General conditions CSA C22 2 a The essential characteristics the recognition and observance of no601 1 which will ensure that electrical equipment will be used safely approved see and in applications for which it was made shall be marked on certificate the equipment or if this is not po
28. and finished appearance BEID 79 wy METHCAL INC S BHM Voyager Portable Technical File SPECS AT A GLANCE Lifting capacity 200 kg 440 Ibs Retum to charge function initiated by user weight sensor cut out 8 Kg 20 bei Unit weight 11 5 kg 28 Ibs batteries included Power on indicator LED indicator for maintenance required Electronic microprocessor soft start and stop motor control Manual emergency lowenng device lacated on the motor cab Electrical up and down emergency buttons Emergency stopping device pull cord accessible from the ground Overload circuit protection current limiter Low battery disconnect system Low battery indicator audible and visual LED Charging indicators blinking yellow charging full yellow charging completed ABS FR casing fire retardant Double centrifugal emergency brake system in case of mechanical failure Strap length up to 2 3 m 90 in tested for 2727 kg 6000 lbs Lifting speed 6 cm sec 2 4 in sec Batteries 2 X 5 Ah will average 150 cycles loaded at 15 kq 165 lbs Adjustable horizontal displacement speeds 10 15 20 25 cnvsec 4 6 8 10 in fsec Speed set by default 20 cmisec B in sec CSA No 601 1 UL No 2801 1 certifications CE marked Respects EMI standards electromagnetic interference ISO 10535 CHARGER UNIT Power indicator on charging module
29. clean and care for gt S M L Sizes Medium fits most patients small sizes fit most paediatric patients large fits tall or very stocky patients Patient must have muscle tone in upper body to use this sling v Eli 95 PHM Voyager Portable Technical File Xn dl VW cua THE WALKING SLING THE WALKING SLING HELPS TO HOLD PATIENTS IN A STANDING POSITION DURING WALKING EXERCISES IT CAN PROVIDE COMPLETE OR PARTIAL SUPPORT PRODUCT TEM S TEM M TEM L Designed to assist people with limited ability to walk this sling helps support and assist in rehabilitation Fully padded with a security buckle the sling is comfortable and simple to use The user must have some weight bearing ability Fits all BHM ceiling lift models as well as the Ergolift mobile lift Available in sizes S M amp L Weight capacity is 250 kg 550 Ibs 1 Do not use the Walking sling on a patient who does not have weight bearing ability and good muscle tone in their shoulders and neck Check with the patient s physician nurse or medical specialist before using this sling SLING DIMENSIONS WALKING SLING PRODUCT TEM Ri SIZE A B C CM IN CM IN CM IN SMALL 25 4 10 50 8 20 73 66 29 7 MEDIUM 30 48 12 68 58 27 91 44 36 LARGE 30 48 12 86 36 34 111 76 44 EXERIVR 96 PHM Voyager Portable Technical File Xn VW com SLING SIZES AND PRODUCT NUMBERS SMALL l MEDIUM LARGE CHEST
30. for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb unless they are implantable or long term invasive devices in which case they are in Class III N A 4 3 15 All devices intended specifically to be used for disinfecting cleaning rinsing or when appropriate hydrating contact lenses are in Class IIb All devices intended specifically to be used for disinfecting medical devices are in Class IIa This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action N A 44 16 Non active devices specifically intended for recording of X ray diagnostic images are in Class Ila N A 4 5 17 All devices manufactured utilizing animal tissues or derivatives rendered non viable are Class 111 except where such devices are intended to come into contact with intact skin only N A 18 By derogation from other rules blood bags are in Class IIb N A No other rules supersede de rule 1 and 2 than the device is Class 1 This text don t reproduce the directive but to do refer at this v GE 27 ELA e Voyager Portable Technical File IA VW cum Appendix 2 2 1 Directive 93 42 EEC Annex I Essential requirements Directive 93 42 EEC Concerning Medical Devices June 1994 Annex I ESSENTIAL REQUIREMENTS Product V4 Clause Requirements Notes Verdict I Gen
31. for use shall contain in addition the name and address of either the person responsible referred to in Article 14 2 or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community as appropriate Yes b The details strictly necessary for the user to identify the device and the contents of the packaging Yes c Where appropriate the word STERILE N A d Where appropriate the batch code preceded by the word LOT or the serial number N A e Where appropriate an indication of the date by which the device should be used in safety expressed as the year and month N A f Where appropriate an indication that the device is for single use N A g Ifthe device is custom made the words custom made device N A h If the device is intended for clinical investigations the words exclusively for clinical investigations N A v Elali 31 S BHW The instructions for use must also include details allowing the medical staff to brief the patient on any contra indications and any precautions to be taken These details should cover in particular i Any special storage and or handling conditions N A j Any special operating instructions N A k Any warnings and or precautions to take Yes 1 Year of manufacture for active devices other than those covered by c This indication may be included in the batch or
32. gt m 4 Y com SOFT STRETCHER FRAME PRODUCT A5515 A A B C SEE CM IN CM IN CM IN MEDIUM 140 55 1 49 19 3 136 53 5 LARGE 140 55 1 89 35 164 64 6 FRAME 120 47 20 8 63 25 CHARACTERISTICS BENEFITS gt Soft Polyester Nylon net Specially designed fabric is ultra soft and long lasting dries quickly excellent for bath transfers gently hugs the patient fabric is easy to move easy to install in bed gt Strong Nylon straps for support Wide straps positioned at the head shoulders hips and legs to provide through support Aids in ensuring the patient is secure in the sling Allows for one person transfer Head Support Two straps support the head to ensure the patient is comfortable and safe Excellent for most supine transfers suitable for 8096 of patients ensures that the patient is fully supported gt White powder coated steel Strong and durable powder coat resist rust frame Frame attached to lift Easy to place sling around patient and attach to frame Frame need to be stored away from the lift gt 550 lbs Lifting capacity Very strong and durable ensures patient safety gt Single Solid Piece Reduces skin irritation from seams increases sling strength and Construction safety gt Machine washable Easy to clean and care for gt M amp L Sizes Medium fits most patients large fits broad patients v Eli 101 tel Voy
33. of conformity issued by the manufacturer or his authorized representative established within the Community Yes The manufacturer or his authorized representative established within the Community should also affix the CE conformity mark to the apparatus or else to the packaging instructions for use or guarantee certificate Yes 10 2 The manufacturer or his authorized representative established within the Community shall hold at the disposal of the relevant competent authorities as soon as the apparatus is placed on the market a technical construction file This file shall Describe the apparatus Set out the procedures used to ensure conformity of the Yes apparatus with the protection requirements referred to in Article 4 Yes Include a technical report or certificate one or other obtained from a competent body Yes Annexe I EC declaration of conformity 1 The EC declaration of conformity contain the description and information to ensure the conformity of the apparatus Yes 2 The CE conformity marking Yes Annexe II Criteria for the assessment of the bodies to be notified N A Annex III List of the principal protection requirements See CSA Certification This text don t reproduce the directive but to refer at this v lalala 35 Voyager Portable Technical File lt gt BHW Appendix 2 2 3 b Standard EN 12182 Standard EN 12182 Devices for Disable Persons General Requir
34. positioning loops flexibility for many types of patients or pressure points Special Leg Strap design Ensures the security of the patient extremely mobile patients cannot fall out leg can be positioned Head Support Excellent for most general transfers suitable for 80 of patients ensures that the patient is fully supported Positioning Handles Patient can be transferred to any position from any position positions patient properly in the chair no second adjustment needed transferring from lying position to seated position fast and easy provides a safe place for caregiver to turn the patient gt 550 lbs lifting capacity Very strong and durable ensures patient safety Single Solid Piece No skin irritation from seams increases sling strength and Construction safety gt Machine washable gt S M L Sizes Medium fits most patients small sizes fit most paediatric patients large fits tall patients Hammock 6 Strap additional features gt Weight distribution inserts Distributes the weight evenly throughout the sling no pinching gt Additional straps at the hip Provides a more secure feeling for the patient prevent low tone atients from leaning to the side gt Tightened Head Support Provides additional support for the head sling gently support more of the upper body v BHM d Voyager Portable Technical File lt gt BHW THE QUICK FIT
35. strap This indicates the higher position of the strap The lower limit is sensed when the drum tries to rol the strap into the wrong direction This will activate the switch and stops the motor 21 End of rail s left right Both ends of the rails are closed by stoppers 22 Railand rail support The tail and supports are made of aluminum 66081 T5 1329500 10 0d BEID 54 wy MEINCAL INC BEM Voyager Portable Technical File Y care 03 07 07 JEU 14 45 Fat 18198652219 BHM MEDICAL INC 181011 MASTER CONTRACT 184445 REPORT 1329600 Page No 11 PROJECT 1329600 Date Issucd October 4 2002 PARTE 7 DESCRIPTION Universal battery charger model 700 15500 is used ta recharge a 24 Vde Sealed Lead Acid Batteries for usage with DITM patient lifters scrics a Type of Equipment Portable equipment byClass of Equipment Class TI c l ype of Power system Switching power supply cord connected rated input 100 240 Vac 50 60 Hz rated output 26 30 Vdc at 27V A max d Weighl of equipment approx 0 5 kg 1 Main Enclosure Accepted Manufacturer mold MI Plastcch Moules Industricls Model 200 15500 200 15510 200 15520 200 15530 200 15535 Dimensions 110x90x55 by 1 9 nuni thick Material Manufacturer Bayer Plastics Material Bayblend FR 2000 Ratings V 0 at 1 6 mm min Mounting Top and bottom parts assembled by 2 torx screws cons Ventilation Openings bb top openings none Rack npenings none Side openings none
36. 00 11140 1 TRACK BRACKET d 700 11100 FLAT WASHER 10mm 000 04430 LAG BOLT 3 8 CEILING SHEET ROCK WOOD BEAM INSTALLATION 2 X 6 BETWEEN BEAMS WOODEN et caos ooo 91715 07900 04575 WASHER 126m 1 VISIBLE UNISTRUT 8000 61210 QUITE PAINTED LAS BOLT 38 Wooden beam Shim 12 mm 200 11170 t Track bracket Flat washer 10 mm A 700 11100 Hex bolt 3 8 16 X 2 1 4 or longer WOODEN BEAM H TRACK N S BHM Pag DO NC RETE HLTI TOR 351 BT 000 10423 LE SHIM 12nm CEILING PLATE a tm 11170 200 1114 TRACK BRACKET 700 11 10m FLAT WASHER tmm omnium HEX 3OLT 38 1 X 2 17 0010035 SUSPENDED CEILING WITH CONCRETE STRUCTURE HEX NUT 2816 mm m CEIUNG PLATE 200 11140 THREADED ROD 8 16 SUSPENDED CELING Insert a ceiling plate Install track brackets as shown on diagram below Concrete Suspended Track bracket Colling 700 11100 Ceiling plate 200 11140 Flat washer 10 mm 29 000 04430 Stover locknut 3 8 16 Voyager Portable Technical File CONCRETE H TRACK SUSPENDED CHLHG Teck NN NOT SECURE NENA LOCKING TOOL 005 11100 lt q Make sure that brackets are properly locked Check the strength of the installation 112 S BRM i Lateral Brace 700 11350 Installation We recommend the usage of la
37. 050 SHAFT 12MM 2 25 200 14060 STRAP GUIDE ROLL 1 26 200 14070 HIGH LIMIT PLATE 1 27 200 14080 BATTERY SUPPORT 2 28 200 14090 LIMIT SWITCH SUPPORT 1 29 200 14210 GEAR 46 TOOTH 2 30 200 14220 BUSHING IDLER 2 31 200 14230 CBLM BLOCK PLATE 1 32 200 14240 MAIN PCB SUPPORT 1 33 200 14250 LR MOTOR GEAR 1 34 200 14260 V4 SSRS ENABLER 1 35 200 14500 UPPER SHELL STEEL BLUE 1 36 200 14510 MAIN SHELL 1 37 200 14520 STEEL BLUE PANEL 1 38 200 14530 TOOL DOOR 1 39 400 14000 VERTICAL MOTOR 1 40 403 10500 BATTERY12V 5Ah 2 41 460 00005 SWITCH DB2 TERMINAL 0 110 1 42 492 00035 1 MAIN CIRCUIT BOARD 1 43 700 13300 DRUM SUB ASSY 1 44 700 14020 TROLLEY SUB ASSY 1 45 E0006 MOTOR 1 46 000 01960 SCREW M2 5 X 12 ZINC 2 47 362 14000 V4 BLACK STRAP 1 v GE 86 ELA e Voyager Portable Technical File IA Y com Appendix 4 1 3 a Accessories ACCESSOIRES CLIP ON CHARGER AND CHARGING STATION Product No 700 15500 RAIL STOPPER SPREADER BAR Product No 700 05490 ERGOSCALE WEIGHING DEVICE Product No 700 14800 TRAPEZE BAR Product No A5700 HAND CONTROL FOR V4 6 buttons Product No 700 13650 v Elali 87 Voyager Portable Technical File e BHM THE ERGOSCALE The Ergoscale is a compact precision scale system designed specifically for use with BHM s patient lifts Completely self contained the Ergoscale combines the latest in precision strain gauge technology and microprocessor signal condit
38. 1018 49200041 2 sch 1 Fri Now 91 66 58 58 2002 4920004 D 5C4 BHM MEOCAL ING CIRCUIT DE CONTACT CHARGEUR V4 FAL H Bild E MIRTEK 5 4 PLAQUE CONTACT Can 6 24y CHARGEUR METE e Gyu Laon ind hoat mt CQC 1329600 haer za cena BEIS IMEIHCAL INC 62 BEM Voyager Portable Technical File Y coos 03 07 07 JEL 14 49 FAX 19199852249 BHM MEDICAL INC 141019 700 15500 VIEW sen 1 Fri Nov 01 07 08 55 2002 ert CAME 412 Q0031 GREUIT E co fen Cat NC 706 3300 CHAROER REER fee RRA BRA Le disal taz DCPUOSET VALLEN Loes Seheri GE 63 wy MEINCAL INC Voyager Portable Technical File lt gt BHM 03 07 02 JEU 14 49 Faz 191990582249 BHM MEDICAL INC 14020 NA L VY A Gerke A gt r5 ini ves SEI 51 558 wos 529 T x T7 Zor z S ES za oz SS au S 9 56 Aa LI ek J 35 d z amp B Wel 5 mr T um sl 3 D a d REPORTE 18444 51320800 AHK Medical ne x PROJECT 1420600 Mecnanical Draw i 4 GE 64 Bi IMEIHCAL INC Voyager Portable Technical File LE j i021 BHM MEDICAL IRC 203 JEU 14 49 Faz 181235052243 03 07 Ta CEE A Ss 1921101 deeg AND TARER AA NZ 3aai3WITil 10 OA Hd 887 IL 3H NUN reis Wr R H NADIA 5 sarg 3SSYH 4un ga zez INCA hots INNOVA SEY BT Sb NTE 20 SANFO HCLYN So nara LON TAL WWiarchauuz Y 721800 n t
39. 40 to 70 C Relative Humidity Operating 30 to 75 Storage 10 t0100 Pressure Operating 700 bPa to 1060 hPa 2000 m Max Storage 500 hPa to 1060 hPa 2000 m Max D The accompanying documents include a glossary of symbols used on the product and in accompanying documents The following syuibols ar explained in Le accompauyioy ducunieuts Alleruzting Current Direct current and Attention Consult Accompanying Documents 9 All markings symhols and warning statements appearing nn the equipment appear in each of the accumnpariyig documents b The technical description includes a statement that the supplier will make available on request circuit diagrams component part liste etc JL ERATIONS l The units are marked as noted under MARKINGS above 1329600 4 ad BEIS 48 wy MEINCAL INC BHR Voyager Portable Technical File WE comm 03 07 03 JEU 14 42 FaX 131996822419 BHM MEDICAL INC 181005 MASTER CONTRACT 184445 REPORT 1329600 Page Na 5 PROJECT 1329600 Date Issued October 4 2002 FACTORY TESTS REQUIRED The equipment at the conclusion of manufacture before shipment shall bo subjected to the following tests which may be made at room temperature LDTELECTRIC STRENGTH Equipment The equipment at the conclusion of manufacture before shipment shall withstand for one minute without breakdown the application of 1500W ac between the mains part and body of the equipment Note Although AC voltages are quoted
40. 5 2 OK 16 Hoist for support user resist at the strength and stability test Yes in 16 2 17 Portable hoist no standard exigencies N A 18 Surfaces corners and sides shall be smooth and burrs Yes v GE 36 S BHW Voyager Portable Technical File exempt 19 Manual portable device no standard requirement N A 20 Manipulation handles N A 21 Human tissues tense N A 22 The ergonomics of the hoists shall bee based on the Yes requirements of EN 614 1 23 Information giving par the manufacturer conform to the EN 1041 and have 1 Security and devices combination recommendation Yes 2 Information comprehensible by person with reading Symbols Yes difficulties Yes 3 Maintenance and cleaning instruction Yes 4 Maximum load N A 5 In flammability information N A 6 Electromagnetic compatibility recommendation 7 Description of the maintenance and maintenance N A product if washable N A 8 Description of the disinfections method N A 9 Noise risks warning 24 Risks analysis of storage Requirements of EN 1441 Risks analysis applied This text don t reproduce the directive but to refer at this v GE 37 S BHW Voyager Portable Technical File Appendix 2 2 4 Standard EN 1441 Risk Analysis Standard EN 1441 Medical Devices Risks Analysis April 1998 Product V4 Clause Requirements Notes Verdict 3 Procedure 3 1 General the analysis
41. 80 80 Fax 44 171 972 8109 v GE 71 BEIRA e Voyager Portable Technical File Sicht VW com Appendix 3 1 4 Identical models lt gt BHM Declaration of Identical models COMPANY BHM MEDICAL INC ADDRESS 2001 Tanguay Magog Qc Canada J1X 5Y5 TELEPHONE 819 868 0441 FAX 819 868 2249 PRODUCT CEILING PRODUCT V4 MODELS VOYAGER 420PLUS V420PLUS VOYGAER V4 V4 Declares that the product s name V420PLUS is exactly the same component assembly then the V4 at exception the V420PLUS the safe working load indicated is 190kg 420lbs It is brand name only for different market s MADE IN MAGOG QUEBEC CANADA BY R al Pedneault Research and Development Department DATE August 2 2003 luli 72 EI Voyager Portable Technical File DE ER VW cum Appendix 3 2 1 Extract of safety instructions advertisings and warnings General DO NO ATTEMPTS TO USE THIS EQUIPMEENT WITHOUT UNDERSTANDING THIS To ensure safe operation read the entire manual carefully especially the section on Safety Instruction and Warnings before installing operating or servicing this equipment If anything is not completely understood please contact your supplier for more details Failure to comply with warnings in this manual may result in injury Keep this manual with the lift and refer to it as required Contents of this manual are subject to change without prior notice to users
42. ATURES New safety belt type lift strap for proven strength and durability is tested to 2727 ka 6000 lbs Power Emergency UP and DOWN with an easily accessible MAMUAL emergency down Welght Sensor on Return ta Charge Function automatically shuts the lift off if it senses a weight of Y kg 20 lbs or more No risk of the carry bar pulling trapezes furniture or loaded IV poles on the way tothe charger Na welds pr chains to fail Components are press fitted with mechanically intedocking parts Strong direct drive nylatron gears power the lift Soft start and stop mechanisms smooth the transition between lift functions Dual emergency centrifugal brake system eliminate any free fall potential Current limiting device will shut the lift off if an over weight lift is attempted CLIP ON CHARGER Altaches without taols and can be placed anywhere along the track An added convenience in multi bed rooms Allows you to reposition the charger to suit a changing furniture layout NEW COMFORTABLE HANDSET Its ergonomic design snugly fits the hand and does not restrict the caregiver during transfers NEW KWIKtrak RAIL SYSTEM Uses a revolutionary patented bracket that is 40 faster to install than conventional brackets lts unique locking device keeps the track securely fastened e KWIKtrak s slim design permits a tight 585 mm 23 in turning radius on curves Smooth Seamless joints using amp unique pin locking system improves lateral movement
43. Always use the same colour loop on the rear shoulder straps for both sides of the sling CHARACTERISTICS BENEFITS gt Soft Polyester Nylon net Specially designed fabric is ultra soft and long lasting gently upper hugs the patient fabric is easy to move easy to install in bed gt Soft Padded leg area Easy to install on a seated patient patient never has to sit on the sling slides without irritation to the patient s skin gt Strong Nylon straps with Patient can be seated and semi reclined provides flexibility for positioning loops many types of patients Special Leg Strap Design Ensures the security of the patient legs can be positioned together semi open and open ExtraSturdy Excellent for obese and stocky patients extra room for tights and hips hip strap to support weight on the sides Positioning Handles Patient can be transferred to any position from any position positions patient properly in the chair no second adjustment needed transferring from lying position to seated position is fast and easy provides a safe place for caregiver to turn the patient gt 550 bs Lifting capacity Very strong and durable ensures patient safety gt Machine washable Easy to clean and care for gt S M L Sizes Medium fits most patients small sizes fit most paediatric patients large fits tall or very stocky patients v Eli 93 eo BHM Voyage
44. BHM Medical Inc 2001 Tanguay Street Magog Quebec Canada JIX 5Y5 How to contact us North America BHM Medical Inc 2001 Tanguay Street Magog Quebec Canada J1X 5Y5 Phone 819 868 0441 service calls during business hours 8 00 12 00 and 1 00 5 00 p m E S T service calls outside regular business hours Extension 6199 you must press the pound key Fax 819 868 2249 Web site www bhm medical com E mail bhm bhm medical com 1 3 Subcontractors and location BHM Medical designs all parts in Quebec Canada except of batteries and motor Subcontractors manufacture majority of parts in Quebec Canada Elvi manufactures motor in Italy Batteries and some electronic parts are manufactured in Asia For more information see annex 2 5 2 b BHM Medical assembles lift and accessories in Quebec Canada More information on suppliers and subcontractors are available v EHW 4 BEI VA serie Technical file WV cum 2 Standards procedure 2 1 CE Marking procedure 2 1 1 Route of compliance According to the Council Directive 93 42 EEC Article 11 5 The manufacturer shall in order to affix the CE marking follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on market lass I Class EC Declaration of Conformity Annex VII Quality Assurance Clinical investigation or custom made No applicable 2 1 2 Declaration of conformity See
45. II ACCORDING TO UL COMMUTATOR GLASS vo 15 Limit Switch 1 52 INT Certified UR cUR Manufacturer Cherry TLS Entreprise Type SPDT Rating LOA 125 250V ac 3A 125 250Vac Cat N DB2CCIAA SM 00 3A P 16 Frame Alternative Frame is made of steel 2 64 mm thick I he structure forms a box 164 mm x 140 mra wide by 124 mm high Other mechanical parts are fixed to this frame NB The Done and steel parts are protected against rust by a zinc plated treatment Aluminum parts are protected by heredite or anodize plated treatment KZ H Displacement Vertical up down drum The matar CET AT withont gearbox drives a 30 teeth worm gear double tread The worm gear drives a shaf op which lies a worm This worm drives a second worm gear directly attached to the drum The total obtained ratio is 375 1 18 Stran The strap is a threaded nylon that can hold up tn 2727 kg 6000 th Brand La Gran Pattern 26472 Section 49 mm x 1 2 mm thick 19 Displacement Horizontal oft tight The motor ELVI with integrated gear box drives a spur gear that drives two idlers Those idlers directly drive the wheel The wheels are made of plastic over molded on ball bearings Wheels are fixed on trolley with spring pins Steel trolley is fixed to the frame by three interlocks and secured with another interlock and a MS screw 20 End of strap stopper up down In the unit a limit switch 1s attached on a steel blade sensing the double thickness of the
46. MANUEL WARNING this symbol is intented to alert the user to hazards or unsafe pratices which could result in serious bodily harm CAUTION this symbol is intented to alert the user of the presence of important operating and maintenance instructions which could prevent product damage or possible personal injury procedures NOTE this symbol offers helpful information concerning certain operating AN SAFETY INSTRUCTIONS AND WARNINGS v v v vv V WV gt GENERAL IMPORTANT READ THESE INSTRUCTIONS CAREFULLY OR SERIOUS UNJURY MAY RESULT KEEP THESE INSTRUCTIONS AND THE KEY PROVIDED WITH THE LIFT AT ALL TIMES READ OPERATION AND MAINTENANCE INSTRUCTIONS IN THIS MANUAL BEFORE INSTALLING OPERATING OR SERVICING THIS EQUIPEMENT BHM Medical ceiling lifts must be installed by an authorized contractor or installer YOUR LIFT is for transferring patients only Do not use the lift for any other purpose ALWAYS carry out the daily checklist before using the lift BHM Medical ceiling lifts are specifically designed for BHM Medical ceiling rail systems slings and accessories Slings and accessories designed by any other manufacturer are prohibited and will void BHM Medical warranty Use only Ergofit slings and accessories to maintain patient safety and product utility v lalala 73 ELA e Voyager Portable Technical File IA Y com gt V
47. RNATIONAL i Supplement to Certificate of Compliance Certificate 1329600 Master Contract 184445 The products listed including the latest revision described below are eligible to he marked in accordance with the referenced Certificate Product Certification History Project Date Description 1329600 October 4 2002 Original Certification DO 2002404 30 GU Y mana 45 BEM Voyager Portable Technical File Y coos Appendix 2 5 2 b CSA Report V4 09 07 09 JEU 11 10 FAT 181908652210 BHM MEDICAL INC 14002 Descriptive and Test Report MASTER CONTRACT 181145 REPORT 1329600 PROJECT 1329600 Edition 1 October 4 2002 Project 1329600 Montreal Issued by M Brossoit Eng Contents Certiticate of Compliance Pages 1 to 2 Supplement to Certificate of Compliauce Pave 1 Description and Tests Pages to 15 Electrical Schematics 1 to 4 Mechanical Drawing 1 to 10 Fhotograph to 12 Copy far CSA Montreal Office only Annexe 1 Guide de l utilisateur Juillet 2002 PRODUCTS CLASS 6750 01 MEDICAL ELECTRICAL EQUIPMENT CLASS 8750 1 MEDICAL ELECTRICAL EQUIPMENT CERTIFIED TO U S STANDARDS Part A Patient lifter on ceiling track battery operated cord connected via battery charger VOYAGER series model V4 rated 24Vde 15A maximum load 273 kg 600 bs and model 420 PLUS rated 24V dc 13A maximum load 190 kg 426Ihs 1 Type nf protection against electric shock Internally Power
48. RPH V4 serie Technical file LIFTING DEVICES FOR PERSONS V4 Ceiling Lift TECHNICAL DOCUMENTATION a 2001 Tanguay Street y Magog Quebec Canada JIX 5Y5 Y pum se Fax 819 868 2249 Revised August 2003 v BHM 1 BEI VA serie Technical file Technical file content 1 Introduction 1 1 Product identification 1 2 Manufacturer and location 1 3 Subcontractors and location 2 Standards procedure 2 1 CE Marking procedure 2 1 1 Route of compliance 2 1 2 Declaration of conformity 2 1 3 National and European device classification annex IX 2 2 European Directives and Standards 221 Directive Medical Devices 93 42 EEC 2 2 2 Directive 73 23 EEC Electrical Equipment 2 2 3 European Standard 89 336 EEC 2 2 4 Risk Analysis EN 1441 for Europe security and performance 2 3 Authorized European Union representation 2 4 Specific standards 24 1 ISO 10535 24 2 CSA 601 1 EN 60601 1 UL 2601 1 2 4 3 CSA Z323 5 1998 2 5 Lifetime of products 2 6 Quality Assurance procedures and certificate 23 Post Market Surveillance 2 7 1 Complaints and incidents reported 2 7 2 Advisory notices and recalls 2 7 3 Competent authorities 3 Description of Product 3 1 General Description 3 1 1 Description of product GO 00 NYA N NNN GCA A A AAA A Ur Ur Uta ta ta nn ES E 3 1 2 Parts descr
49. SIZE 68 89 cm 27 35 89 107 cm 35 42 107 125 cm 42 497 PRODUCT TEM S TEM M TEM L COLOR CODE Red Yellow Green Sling attachment to Carry Bar Use the same colour loop on the chest straps for both sides of the sling CHARACTERISTICS BENEFITS Waist band and leg straps Excellent for rehab uses narrow padded strap support through the legs enables patient to walk with the security of knowing they are fully supported e Always use the same colour loop on the rear shoulder straps for both sides of the sling gt Padded and quilted Specially designed fabric is ultra soft and long lasting provides Polyester Nylon extra comfort for the patient fabric is easy to move gt Padded waist band with belt Easy to install on a seated patient m padding around entire waist reduces pressure gt Strong Nylon straps with Patient can be positioned forward straight or slightly backward positioning loops adjustable straps allow for patients with a large midsection provides flexibility for many types of patients Special Leg Strap design Leg straps are fully padded to reduce pressure straps are adjustable to patient size gt 550 lbs listing capacity Very strong and durable ensure patient safety Machine washable Easy to clean and care for gt S M L Sizes Medium fits most patients small sizes fit most paediatric patients large fits tall or very sto
50. SLING THE QUICK FIT SLIG IS PERFECTLY SUITED FOR STOCKY OR OBESE PATIENTS WITH LARGE HIPS OR THIGHS USED FOR GENERAL TRANSFERS PRODUCT TIR S TIR M TIR L Specially designed for patients who are stocky or obese especially in the midsection Padding around the buttock and leg area helps to provide extra support Upper portion of the sling is a mesh type material that dries quickly but is soft and pliable This sling does not provide head support The patient may be lifted in a seated semi reclined or fully reclined position Fits all BHM ceiling lift models as well as the Ergolift mobile lift Available in sizes S M amp L Weight capacity is 250 kg 550 lbs AN Do not use the Quick Fit sling on a patient who cannot support his or her own head SLING SIZES AND PRODUCT NUMBERS LARGE 20 46 kg 45 100 Ibs 46 95 kg 100 210 Ibs Approximate height 120 150 cm 4 411 151 180 cm 57 5117 181 cm 6 Red Yellow Green TIR S TIR M TIR L SLING DIMENSIONS QUICK FIT SLING PRODUCT TIR v Elali 92 PHM Voyager Portable Technical File AU VW cua SIZE A B 6 D CM IN CM IN CM IN CM IN SMALL 101 6 40 55 88 22 88 9 35 30 48 12 MEDIUM 116 84 46 66 04 26 99 06 39 35 56 14 LARGE 4270 50 71 1228 109 22 43 35 56 14 Sling attachment to Carry Bar Use the same colour loop on the hip straps for both sides of the sling
51. V VV ON WV v v BHM Medical ceiling lifts are intented to be used for patients within the specified weight limit indicated for the lift Do not attempt to lift more than the weight limit indicated Before attempting to transfer the patient must be assessed by a qualified professional BHM Medical ceiling lifts must be used by a caregiver with proper training to work with the patient to be transferred ONLY trained and qualified caregivers should transfer a patient DO NOT attempt to use the lift if you have not been properly trained to do so ALWAYS be prepared before attempting to transfer a patient DO NOT use a sling that is not recommanded for the lift NEVER use a damaged torn or frayed sling ALWAYS place the sling around the patient according to the instructions enclosed FOLLOW lifting procedures outlined in this manual USE all controls and safety features only according to the rules specified in this manual Never attempt to force a control or button on the lift DO NOT store the charger in a shoer bath or other areas with high humidity DO NOT drop the patient lift or batteries Dropping the lift or batteries may cause internal damage that is not easily seen If lift is suspected to be damaged take to an authorized technician for servicing IMPORTANT Keep all components of the lift clean and dry and have electrical and mechanical safety checkpoints done as instructed in the Maintenance section of this manual
52. W Mountings Securely soldered to pc board 13 Transistor O1 Accepted Manufacturer International Rectifier Model IRFI820G Type Power MOSFET Ratings Vdss S00V Rds 3 0 ohms Id 2 1A Mountings Securely soldered to pc board 14 Opto coupler 02 CSA UL V DE F S N D Manufacturer LITEON Model CNY 17F 3 mE Type Iligh Collector Emitter Voltage v Ratings Isolation 5000 Vac BVCEO 70V Muunlings Securely soldered to pc board 15 Main Transformer T1 Certified CSA UR Manufacturer ATC Frost Designation 865670 FF513 141013 Page No 13 Date Issued October 4 2002 Type Split bobbin dual primary thermally protected open cure aud coil Rating Primary 90 260 Vac 50 60 Hz 27VA Secondary 27 Vac ilA Windings Enamelled copper wire Primary Pin 2 7 90 260 50 60 Hz 34 AWG single poly NYLEZE magnet wire MWS 0 C or equivalent 120 turns Secondary Pin 4 9 27Vac 1 0 A 50 60 Hz 26 AWG single poly NYLEZE magnet wire MW80 C or equivalent 30 turns Core Ferrite Core approx 25 nuu by 25 mui by 7 2 mem Mounting Secured soldered to pe board General Insulation Class A 105 C per LL 1446 Insulation system Bobbin Glass fiber reinforced GF Mylon 6 6 0 8 mm thick min 2 flanges Manufacturer Dupont Designation Dupont Rynite FR 530 Inaulation Class B 30 C VU PET Bobbin Shroud Glass fiber reinforced GT Nylon 6 6 0 8 mm thick min Manufacturer Dupont o Designation
53. abric gently hugs the patients fabric is easy to move Easy to manipulate easy to install Adjustable headrest and footrest gt Stainless Steel Frame Easily assembled around patient by slipping frame parts into loops of sling Frame is rust resistant so can be submerged in water Rust resistant gt 240 kg 550 lbs lifting capacity Very strong and durable ensures patient safety gt Machine washable Easy to clean and care for v BHM 105 BEM Voyager Portable Technical File THE ERGOFIT PLUS SLING CN KE gt C f Y d Y AA FRAME PRODUCT 700 05550 PRODUCT Our truly bariatic size sling is designed for the special needs of a bariatric patient weighing from 182 455 kg 400 to 1000 lbs Polyester nylon material moves easily to reduce friction on tender skin The area around the legs and buttocks is padded adding additional support and comfort Positioning loops and handles allow you to adjust the position the person is transferred in as well as position the person properly into a chair The Ergofit Plus sling is designed to be used only in conjunction with the Ergofit Plus 4 point frame The frame fits all Voyager Series overhead ceiling lifts and the Ergolift mobile lift TOILE TOB HA SLING DIMENSIONS ERGOFIT PLUS SLING PRODUCT TOB HA ERGOFIT PLUS FRAME PRODUCT 700 05550 SE cum 2m cni SLING ONE 109 5 43 134 53 E
54. ager Portable Technical File FRAMED SLAT STRETCHER The frame slat stretcher is ideal for prone position transfers where the person should bot are disturbed during manual or lifter transfers The frame can be assembled around and injured or immobilized patient The patient is supported by a series of semi rigid cross support slats which are individually inserted beneath the patient s limbs and body Ideal for spinal or postoperative orthopaedic care Can be used with both the Voyager Series and the Ergolift Mobile Floor Lift SLING DIMENSIONS FRAME SLAT STRETCHER PRODUCT 17200 Ki a Ne A CM IN ONE SIZE 71 27 9 190 74 8 CHARACTERISTICS BENEFITS gt Semi Rigid Cross Support Specially design to be easily inserted under patient Straps Polypropylene Can be used anywhere Gliders can be fitted diagonally to avoid injured areas Each slat is adjustable to allow for desired tension under patient A glider can be left out for toileting or mound dressing gt White powder coated steel Can be assembled around injured or immobilized patient frame Easy to use plastic locking clip makes assembly easy and secure gt 230kg 500 lbs lifting Very strong capacity gt Sturdy nylon straps in The loops offer the flexibility of adjusting the frame to the required positioning loops height Great for high lifts manoeuvres example bed to bed gt Versatile Can be
55. annex 2 1 2 Declaration of conformity 2 1 3 National and European device classification annex IX See annex 2 1 3 Directive 93 42 EEC annex IX 2 2 European Directives and Standards 2 2 1 Directive Medical Devices 93 42 EEC See annex 2 2 1 Directive 93 42 EEC Annex I Essential Requirements 2 2 2 Directive 73 23 EEC Electrical Equipment See annex 2 2 2 Directive 73 23 EEC Annex 1 2 2 3 European Standard 89 336 EEC See annex 2 2 3 Directive 89 336 EEC v BHM 5 BEI VA serie Technical file WV cer 2 2 4 Risk Analysis EN 1441 for Europe security and performance See annex 2 2 4 Risk Analysis 2 3 Authorized European Union representation BHM Medical general representative for Europe EHS European Healthcare Solutions 14 Cross Street Barnes London SW13 OPS United Kingdom BHM Medical authorized distributors for Europe partial list Sunrise Medical Ltd High Street Wollaston West Midlands DY8 4PS England RMT Reha Med Technology 63322 RODERMARK Germany 2 4 Specific standards 2 4 1 ISO 10535 Test report available 2 4 2 CSA 601 1 EN 60601 1 UL 2601 1 See appendix 2 4 2 a CSA Certificate of Compliance V4 See appendix 2 4 2 b CSA report V4 2 4 3 CSA Z323 5 1998 Test report available 2 5 Lifetime of products These product are designed manufactured and tested for a lifetime corresponding at 10 000 cycles of use The mechanism shall be maintained according to manufacturer instructions The lifeti
56. blems arising from normal wear or failure to adhere to the instructions in this manual BHM Medical Inc slings are void of warranty if not laundered as per instructions on the Sling Label BHM Medical Inc shall not be liable for damages losses or inconveniences caused by a carrier This warranty replaces any other warranty expressed or implicit and constitutes BHM Medical Inc only obligation towards the purchaser BHM Medical shall not be liable for any consequential or incidental damages whatsoever Valid only if BHM Medical did the original installation Guarantee void if tracks installation have been modified v Ely 13 PHM Voyager Portable Technical File 3 3 2 Photograph of product and use See also user and technical manuals 3 3 3 Brochure advertising marketing claims See annex 3 3 3 Also available at BHM Medical or ask your local representative 3 3 4 Packaging specifications transport and storage conditions Duration Not exceeding 15 weeks for transport and storage Handling Do not drop de product Environmental conditions Ambient temperature range of 40 C to 70 C Relative humidity range of 10 to 100 Atmospheric pressure range of 50 to 106 Kpa BHM Medical recommends charging of batteries at least every two weeks even if the lift is not used This will prevent premature aging of batteries 3 3 5 Details of product labelling instructions for use and other literature Ask your local representati
57. ces Pommelin 166 PO Box 55 Centre MDD Fax 4358 9 4733 4266 National Agency FIN 00301 For Medicines IVD Helsinki IVD Dr Jarkko jarkko ihalainen Ph 358 9 4733 42 64 lhalainen nam fi AIMD Mr Harry harry sievanen n Fax 358 9 4733 41 MDD Siev nen am fi FRANCE MDD Dr J C claude ghislain AFSSAPS Ph 33 1 55 87 37 47 Agence Fran aise de Ghislain afssaps sante fr 143 147 S curit IVD jean Boulevard Fax 33 1 55 87 37 42 Sanitaire des www afssaps sant Anatole France Produits de Sant e fr F 93285 Saint Denis Cedex GERMANY AIMD Dr E e stoesslein bfar Gesch ftsstelle Ph 49 228 207 53 84 Bundesinstitut f r St Blein m de Medizinprodukte Arzneimittel und MDD BfArM Fax 49 228 207 53 00 Medizin produkte Friedrich Ebert Allee 38 D 53113 Bonn IVD Dr R r siekmeir bfarm Ph 49 228 207 53 60 Siekmeir de Fax 49 228 207 53 00 IVD Dr s ivd pei de Paul Ehrlich Ph 49 6103 77 7000 J Halbauer Institute PEI or Paul Ehrlich 773114 Strasse 51 Fax 49 6103 77 1268 5963225 Langen v Et 69 BER P Voyager Portable Technical File WE com GREECE Dr G P Nihil Services National Ph 30 1 65 07 380 Demagos Organization for Ministry of Health Medicines Fax 430 1 65 49 585 Welfare and Social 284 Messogion Avenue 15562 Holargos Attikis IRELAND Irish medicaldevices i Irish Medicines Ph 353 1 67 64 971 Medicines Board Ms Ann mb ie Board Fax
58. chnical File IA VW com Appendix 2 1 4 Directive 93 42 EEC Annex IX Directive 93 42 EEC Concerning Medical Devices June 1994 Annex IX CLASSIFICATION CRITERIA Product V4 III Classification Rules Devices concerned Verdict 1 1 1 All non invasive devices are in Class I unless one of the rules set out Class 1 hereinafter applies Applied 1 2 2 All non invasive devices intended for channelling or storing blood body Class 1 liquids or tissues liquids or gases for the purpose of eventual infusion Applied administration or introduction into the body are in Class Ia If they may be connected to an active medical device in Class IIa or a higher class If they are intended for use for storing or channelling blood or other body liquids or for storing organs parts of organs or body tissues In all other cases they are in Class 1 1 3 3 All non invasive devices intended for modifying the biological or chemical N A composition of blood other body liquids or other liquids intended for infusion into the body are in Class llb unless the treatment consists of filtration centrifugation or exchanges of gas heat in which case they are in Class Ila 1 4 4 All non invasive devices which come into contact with injured skin Non Arein Class I if they are intended to be used as a mechanical barrier for invasive compression or for absorption of exudates Are in Class Ilb if they are intended to be used
59. chnical File WE mms Appendix 4 1 1 V4 part list EXPLODED VIEW OF PRODUCT AND PARTS LIST Vv EXER 82 MEIHCAL INC BHR B Voyager Portable Technical File WE cun luli 83 MEIHCAL INC PHR B Voyager Portable Technical File dd vw Elali 84 MEIHCAL INC Voyager Portable Technical File 200 14070 REV 6 Item 8 Part Number 5 1 2 1 Description Qty 1 700 14100 SUB ASSY SHAFT V4 1 2 000 00635 TAP SCREW M4 2 x 9 5 4 3 000 00890 ALUM RIVET 3 16 0 1 8 2 4 000 01370 CORD END INSERT 1 5 000 01375 CORD END SHEATH 1 6 000 01970 LOCK NUT M2 5 2 7 000 02480 TAP PLASTIC SCREW 4 0 X 12 8 8 000 02550 SCREW M5 X 12 HEX ZINC 4 9 000 02562 SCREW M5 X 10 TARSITE 2 10 000 02590 SCREW M5 X 20 TAPTITE 4 11 000 02610 SCREW M5 X 25 HEX ZINC 1 12 000 02655 SCREW M5 X 40 HEX ZINC 2 13 000 02800 LOCKNUT M5 5 14 000 02900 LOCKWASHER M5 4 15 000 02915 STARWASHER M5 1 16 000 03105 SCREW M6 X 16 ZINC STUD 3 17 000 03420 LOCKWASHER M6 3 18 000 03950 O RING 8MM 2MM CORE 1 19 000 03975 ALLEN KEY 8MM SHORT 1 B ID 85 PHR Voyager Portable Technical File dd Item Part Number 5 1 2 1 Description Qty 20 200 14000 FRAME U SHAPE 1 21 200 14010 FRAME TOP PART 1 22 200 14030 LOCK TROLLEY 1 23 200 14040 LR MOTOR PLATE 1 24 200 14
60. choice for most situations including bathing Fits all BHM ceiling lift models as well as the Ergolift Mobile Lift Available in sizes S M amp L Weight capacity is 250 kg 550 Ibs Almost identical to the Hammock sling above this sling provides extra security and a tighter fit for patients who are low tone or who would prefer a more secure feeling The head support is tighter and the extra straps on the side provide more lateral support The patient may be transferred in a seated semi reclined or fully reclined position Fits all BHM ceiling lift models as well as the Ergolift mobile lift Available in sizes S M amp L Weight capacity is 250 kg 550 lbs SLING DIMENSIONS HAMMOCK HAMMOCK 6 PRODUCT THA PRODUIT HTHA6 v Ely 89 wr PHM Voyager Portable Technical File MEDICAL INC SIZE A B C D CM IN CM IN CM IN CM IN HAMMOCK SMALL 106 68 42 76 2 30 66 04 26 22 86 9 HAMMOCK 6 SMALL 106 68 42 76 2 30 66 04 26 22 86 9 HAMMOCK MEDIUM 124 46 49 93 98 37 86 36 34 27 94 11 HAMMOCK 6 MEDIUM 124 46 49 93 98 37 86 36 34 27 94 11 HAMMOCK LARGE 144 78 57 106 68 42 96 52 38 27 94 11 106 68 42 96 52 38 27 94 11 HAMMOCK 6 LARGE 144 78 57 SLING SIZES AND PRODUCT NUMBERS SMALL MEDIUM LARGE Approximate weight 20 46 kg 45 100 Ibs 46 95 kg 100 210 Ibs 95 250 kg 210 550 lbs Approximate height 120 150 cm 4 4 11 151 180 cm 5
61. cky patients v BHM 97 eo BHM Voyager Portable Technical File THE BAND SLING G t THE BAND SLING IS PERFECT FOR THE ERGOSTAND IT HAS A VELCRO WAIST WITH 2 ADDITIONAL BELTS BACK SUPPORTS AND ANTI SLIP MATERIAL FOR THE BACK PRODUCT TST S TST M TST L TSL XL SLING DIMENSIONS BAND SLING PRODUCT TST qup v BHR A B C CM IN CM IN CM IN SMALL 149 86 59 28 96 11 4 107 95 42 5 MEDIUM 149 86 59 32 0 12 6 121 92 48 LARGE 157 99 62 2 35 05 13 8 144 78 57 X LARGE 162 56 64 36 83 14 5 166 37 65 5 SIZE 98 BHR a Voyager Portable Technical File gt n MA WE com CHARACTERISTICS BENEFITS gt Velcro amp Double belted waist Use only with Ergostand Velcro closure adjusts to size band differences double belted waistband secures patient in sling enables patient to stand with the security of knowing they are fully supported easy to install on a seated patient gt Padded and quilted Polyester Specially designed fabric is ultra soft and long lasting provides Nylon extra comfort for the patient fabric is easy to move gt PVC netting Sure grip material keeps the sling in place soft material is gt Extra padding under arms Provides additional cushion for the patient flexible and gentle entle to skin gt Back support strips
62. e Fully enclosed no ventiiation opening permanent magnet provided with integral reducer Cat N 101 663 FC BHM Part number 1E0006 Rating 24Vdc 1 8A 30 Watts 260 RPM 1 0 N m Overall Dimension Secured by screws and lockwaaher to chassis Mounting Secured by screws to chassis A Rotor Laminated steel 42 mm dia by 32 mm high Mounting Crimp to the shaft B Rotor Winding Ename ed copper wire class H UL C Rotor to winding insulation 1 layer of Isotherm 0 25 mm thick Claes E 145 C D Spacer malerial PSU 2010 E Collector Copper 19 mm diam Fj Brush Carbon composition mounted on spring Dimensions Q 9x4 5x10 mm G Brush holder Later 4 G 30 H Motor leads Certified TEW 105 C N 18AWO connecled by cerLified 2 pins AMP cunnector D Motor leads connection to windings crimping MATERIAL TYPE SUPPLIER CERTIFICATION CLASS OF DESCRIPTION TEMPERATURE WINDING COOPER THENVEX INVEX CEI WIRE UL E45523 ROTOR WINDING ISOTERM 1S0COM PETP MYLAR E93687 ALA INSULATION DUPONT POLYESTER FILM E92687 13238620 9 ad BEID 53 wy MEINCAL INC BHR Voyager Portable Technical File 03 07 03 JEU 11 14 FAX 18198682219 BHM MEDICAL INC oia MASTER CONTRACT 184445 REPORT 1329600 Page No 10 PROJECT 1329600 Dale Issued October d 2002 ead SPACER POLYSULFONE RESIN BASF PSU 2010 E4137 PSUZ IU CABLE PVC ROTA CAVI ACCORDING TO THE LEI NORM 2020 DAT A1225 ISULATION OF THE PHENOL RESIN WIT
63. e or reduce as far as possible consequent risks applied 12 2 Devices where the safety of the patients depends on an internal Requireme Yes power supply must be equipped with a means of determining the nts of EN state of the power supply 1441 Risks analysis applied 12 3 Devices where the safety of the patients depends on an external Requireme Yes power supply must include an alarm system to signal any power nts of EN failure 1441 Risks analysis applied 12 4 Devices intended to monitor one or more clinical parameters of a N A patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient s state of health 12 5 Devices must be designed and manufactured in such a way as to CSA Yes minimize the risks of creating electromagnetic fields which could C22 2 impair the operation of other devices or equipment in the usual no601 1 environment approved 12 6 Protection against electrical risks Requireme Yes nts of EN Devices must be designed and manufactured in such a way as to 1441 Risks avoid as far as possible the risk of accidental electric shocks analysis during normal use and in single fault condition provided the applied devices are installed correctly 12 7 Protection against mechanical and thermal risks Requireme 1 Devices must be designed and manufactured in such a way as nts of EN to protect the patient and user against mechanical ris
64. eciprocal interference posed by the presence of the device during specific investigations or treatment N A g The necessary instructions in the event of damage to the sterile packaging and where appropriate details of appropriate methods of resterilization N A h If the device is reusable information on the appropriate processes to allow reuse including cleaning disinfection packaging and where appropriate the method of sterilization of the device to be resterilized and any restriction on the number of reuses N A Where devices are supplied with the intention that they are sterilized before Use the instructions for cleaning and sterilization must be such that if correctly followed the device will still comply with the requirements in Section I 1 Details of any further treatment or handling needed before the device can be used for example sterilization final assembly etc N A j In the case of devices emitting radiation for medical purposes details of the nature type intensity and distribution of this radiation N A v BEIS Voyager Portable Technical File 32 ELA Voyager Portable Technical File DE DER VW cum k Precautions to be taken in the event of changes in the performance of the device OUI 1 Precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields external electrical influences electrostatic discharge pressure or variations in pressure
65. ed Battery 2 Degree of protection against electric shock BF 3 Degree of protection against ingress of water IP21 4 Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flarmmabie anaesthetic mixture with air or with oxygen or nitrons oxide 3 Mode of operation Continuous Duty Cycle 10 min hour The test report shall not he reproduced except in full without the approval of CSA International Sat RAS Fl brtn Steet Pointa G nira Qu bar Grmadn HAR AFA E lelennone 914 694 810 L300 463 6 27 Fax 514 694 5004 wwWww CSU IrTernamonual org 13296007 ad BEES 46 wy MEINCAL INC BEM Voyager Portable Technical File 03 07 03 JEU 11 11 FAT 18198682219 EHM MEDICAL IKC 14003 MASTER CONTRACT 184445 REPORT 1329600 Pape No 2 PROJECT 1320600 Date Issued October 4 2002 7 Part Bi Universal battery charger used to recharge 24Vde Sealed Lead Acid Batteries Model 700 15550 rated input 100 240 Y ac 50 60 Hz rated output 26 30Vde at 27VA max cord connected transportable or desktop unit 1 Type of protection agamst electric shock Class Il 2 Degree of protection against electric shock Not Classified 3 Degree of protection against ingress of water TP20 4 Degree of safety of application in the presence uf a Darormable anaesthetic mixture with air or with oxygen or nitrous oxide Eq
66. edical product In the event that you do not receive satisfactory warranty service please contact BHM Medical see contact information in Table of Contents Do not return products to our factory without prior authorization BHM Medical will issue a Return Merchandise Authorization RMA Number C O D shipments will be refused all shipments to BHM Medical must be prepaid For this warranty to be valid the purchaser must present its original proof of purchase at the moment of the claim The defective unit assembly or part must be returned to BHM Medical for inspection The part or components repaired or replaced are guaranteed for the remaining period of the initial warranty Limitations and Exclusions The warranty above does not apply to serial numbered products if the serial number has been removed or defaced No warranty claim shall apply where the product or any other part thereof has been altered varied modified or damaged either accidentally or through improper or negligent use and storage Warranty does not apply to products modified without BHM Medical s express written consent including but not limited to products modified with unauthorized parts or attachments products damaged by reason of repairs made to any component without the specific consent of BHM Medical or to products damaged by circumstances beyond BHM Medical s control BHM Medical will solely determine evaluation of warranty claim The warranty does not apply to pro
67. ements and Test Methods December 1999 Product V4 Clause Requirements Notes Verdict 4 General requirements 41 Risks analysis Requirements of EN Yes 1441 Risks analysis applied 4 2 Researched performance and technical file a Resistance and durability appropriate with previous the Yes load Yes b Resistance durability and stability describe in the technical file Yes c Technical file make references at books calculations tests and standards 4 3 Clinical evaluation shall be in accordance with EN 540 N A 4 4 The device shall be not possible to assemble in an unsafe Yes method 4 5 These fixation shall be reusable Yes 4 6 No exigencies about user weight N A N A 5 Materials Requirements of EN 1441 Risks analysis applied 6 Noise and vibration shall be evaluated in risks analysis Requirements of EN 1441 Risks analysis applied 7 Electromagnetic compatibility CSA C22 2 no601 1 approved see certificate 8 Electrical safety CSA C22 2 no601 1 approved see certificate 9 Leak and liquid penetration Requirements of EN 1441 Risks analysis applied 10 Surface temp N A 11 Sterility N A 12 Mobile parts safety Requirements of EN 1441 Risks analysis applied 13 Entrapment prevention Requirements of EN 1441 Risks analysis applied 14 Mechanism hazards Requirements of EN N A 1441 Risks analysis applied 15 Transportation handles shall be resist at the test 1
68. endix 3 3 3 Brochure advertising marketing claims BHM Medical s newest generation V4 ceiling track lift combines many of the trusted features of the successful Voyager series along with Tra Ck design improvements and new features you asked for The m NEW V4 is the most Lift conceptually advanced ceiling lift on the market today ergonomically designed hand controller with 2 or 4 way function plus return to charge wireless remote available the next generation in ceiling mounted patient lifts MN CIE I lene sick Cip o locale arseen bat y c anger 78 Bhi Voyager Portable Technical File E ru V v CENTEA NEW DESIGN IMPROVEMENTS NEW SAFETY FEATURES NEW KWiKtrak RAIL SYSTEM WITH PATENTED CEILING ATTACHMENTS NEW CLIP ON CHARGING STATION AESTHETICALLY PLEASING DESIGN The V4 will be the best looking piece of equipment in the room EASIER TO MAINTAIN e Maintenance Light tells you when the lift needs sarvica No more guesswork Modular Design Remove the lift cover without tools ta gain easy access to the batteries The main circuit board has a single plug in connector Lightwelght canstructlon Moving or removing the lift is easier while the lifting capacity of 200 kg 440 Ibs remains the same PROGRAMMABLE FUNCTIONS Use the handset to program lateral speed adjustments or the carry bar position after the return to charge function is completed SAFETY FE
69. enotes a Certified component that can be interchanged for one from another Certified source provided that it has an cquivalont or bettcr clectrical rating the same terminal orientation and that 3mm 120V or 4mm 240V min spacing is maintpined from live parts to protectively earthed parts Asterisk An asterisk denotes that the agency logo appears on the component ELY All references to ELV denote Extra Low Voltage less then 42 4 Y pk secondary circuits SELV All references to SELV denote Extra Low Voltage secondary circuits nr anmpanenits operating at less than 20V rms or 42 4V p p Metal All references to metal denote painted or plated steel min 0 78 mm No 20 MSG Dimensions dim All dimensions specified are approximations only and shown in millimeters mm Internal Wiring All pri SEC and grounding circuit conductors are certified Type TEW TR 64 TR 32 AWM SR PVC or AWM XL PVC and UL listed rated min 80C 300V ac All wiring is suitably routed and secured away from sharp edges and maving parts to prevent chafing of the inenlation Alternatively additional insulation is provided where Lhe wiring passes over sharp edges and through holes Sleeving All thermoplastic and other insulating tubing used in pri and SEC circuits are certified UL Recognized and rated min 105EC 300V a2 or teflon rated min 200EC 300V Crimp Connectors All crimp type connectors uscd in pri SEC and grounding circuits arc certified UL
70. eral requirements 1 The devices must be designed and manufactured in such a way that Requireme Yes when used under the conditions and for the purposes intended they nts of EN will not compromise the clinical condition or the safety of patients 1441 Risks or the safety and health of users or where applicable other persons analysis provided that any risks which may be associated with their use applied constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety 2 The solutions adopted by the manufacturer for the design and Requireme construction of the devices must conform to safety principles nts of EN taking account of the generally acknowledged state of the art 1441 Risks analysis In selecting the most appropriate solutions the manufacturer must applied apply the following principles in the following order Eliminate or reduce risks as far as possible inherently safe design and construction Yes Where appropriate take adequate protection measures including alarms if necessary in relation to risks that cannot be eliminated Yes Inform users of the residual risks due to any shortcomings of the protection measures adopted Yes 3 The devices must achieve the performances intended by the Yes manufacturer and be designed manufactured and packaged in such a way that they are suitable for one or more of the function
71. ertising Warning See annex 3 3 1 Advertising more advertising available in user manual Intended patient population and medical condition For handicapped disabled people in loss of independence and senior citizen without wound The reasonably foreseeable medical conditions is not be used People with wound or spasm medical guidance People without muscular tonus vigilance and precaution v Ely 12 BEIRA Voyager Portable Technical File Xr WV cua 3 3 Market information 3 3 1 Warranty WARRANTY extract This warranty is extended only to the original purchaser user of BHM products BHM Medical Inc warrants its products to be free from defects in material under normal use and service within the periods stated below from the date of purchase If within such warranty period any such product shall be proven to be defective such product shall be repaired or replaced at BHM Medical s option This warranty does not include any labour or shipping charges incurred in replacement part installation or repair of any such product BHM Medical s sole obligation and your exclusive remedy under this warranty shall be limited to such repair and or replacement Patient Lifter 1 year Tracks and installation Life time warranty Weighing Devices 1 year Accessories on Lifter 1 year Slings 1 year Batteries All other lifts 1 year Easytrack System 1 year For warranty service please contact the dealer from whom you purchased the BHM M
72. h oxygen or nitrous oxide 5 Mode of operation Continuous Duty Cycle 10 6min hour The C and US indicators adjacent to the CSA Mark signify thar the produc bus been evaluated to the applicable CSA and ANSVUL Standards for use in Canada and the U S respectively This US indicator includes products eligible to bear the NRTU indicator NRTL i c National Recognized Testing Laboratory is u designation granted by the U S Occupational Safety and Health Administration OSHA to laboratorics which have been recognized to perform certification to U S Standards DOD SOTWD 2002040 SE Gen BEID 43 Y comm PHM Voyager Portable Technical File Y care CSA INTERNATIDNAL Certificate 1329600 Master Contract 184445 Project 1329600 i Date October 4 2002 Part B Universal battery charger used to recharge 24Vdc Sealed Lead Acid Batteries Model 700 1555 0 rated input 100 240Vac 50 60 Hz rated output 26 30Vdc at 27VA max cord connected transportable or desktop unit Type of protection against electric shock Class II 2 Degree of protection against electric shock Not Classified 3 Degree of protection against ingress of water IP20 4 Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anaesthelic mixture with air or with oxygen or nitrous oxide 5 Mode of operation Continuous
73. ift or Voyager ceiling lifts Y MEINCAL INC CHARACTERISTICS BENEFITS gt Standing transfer Encourages ongoing weight bearing capability Provides resident patient with increased participation Patient Resident must be assessed by a nurse or doctor as physically capable of using the Quick Step Versatile Easily attaches to the Ergolift Voyager Portable or the Voyager Series lifts Simple to use Easier to access small rooms or tight areas gt Lightweight 8 kg 18 lbs Easy to move from room to room gt 170 kg 374 lbs capacity Easily transfers 95 of your patients gt Costefficient Can be use with you standard ceiling or mobile lift Purchase of stand assist lift not necessary Reduces back injuries from pivot transfers Thick knee pad Comfortable for the patient Provides support for patients of all heights Removes for easy laundering gt Padded arm bar Patient has a secure grip to help himself or herself Encourages participation of the patient resident gt Specially designed polyester Easy clean and very comfortable durable lasts a long time band sling Band sling covers 90 of patients Slings are quickly and easily installed and removed Fastest and safest methods of transferring to a chair or toilet Ergonomic easy to manoeuvre Designed to pivot easily in tight spaces The caregiver can walk behind the lift easi
74. ig 16 using the measuring supply circuit of Fig 10 at ambient temperature but without a preceding moisture preconditioning treatment Tn cases where tha mimher of settings nf parameters of the equipment ar of switches of the measuring supply circuit or of the application of a metal foil or the application of the measuring device to be performed during the test would be unacceptable and the results of certain tests would indicate the highest value s then the routine tests may be restricted to the setring s provoking these values Warning The factory test e epecified may present a hazard of injury to pereonnel and or property and should only be performed by persons knowledgeable of such hazards and under conditions designed to minimize the possibility of imury 1329500 Sad BEIS 49 Bi IMEIHCAL INC BHR Voyager Portable Technical File 03 07 03 JEU 11 12 FAX 18198652219 BHM MEDICAL INC 14006 MASTER CONTRACT 134445 REPORT 1329600 Page No 6 PROJECT 1229600 Date Issucd October 4 2002 INTRODUCTION Notes Unless stated otherwise Agency Approvals C or CSA or Certified CSA Certified UR UL Recognized UL UL Listed CUL UL Listed ta Canadian Standards The asterisk adjacent to C or L indicates the Agency Mark appears on the component An asterisk behind any other test house s name denotes that their monogram appears on the component The preceding the rnanutacturer s name d
75. intended purpose of the device by analogy with the appropriate methods specified in Directive 75 318 EEC N A 7 5 The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device N A 7 6 Devices must he designed and manufactured in such a way as to reduce as much as possible risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used See Risk Analysis Yes o Infection and microbial contamination N A Construction and environmental properties If the device is intended for use in combination with other devices or equipment the whole combination including the connection system must be safe and must not impair the specified performances of the devices Any restrictions on use must be indicated on the label or in the instructions for use See Instruction s manual for use accessories Yes 9 2 Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible The risk of injury in connection with their physical features including the volume pressure ratio dimensional and where appropriate ergonomic features The risks connected with reasonably foreseeable environmental conditions such as magnetic fields external electrical influences electrostatic discharge
76. ioning to provide stable accurate and repeatable weight data One button Auto Zero Electronics makes patient weighing quick and easy TECHNICAL SPECIFICATIONS 350 kg 770 Ibs 0 2 kg 0 5 be Weight range Display resolution Accuracy 1 0 Display type Liquid crystal with 0 60 high characters 3 15 Power Supply 9 volts standard battery Batteries Life App 3000 readings Modes Kg or Ibs l Enclosure Powder coated stainless steel Size 95 mm 3 75 x 70 mm 2 75 x 80 m vw Elali 88 ELA e Voyager Portable Technical File IA VW com Appendix 4 1 3 b Slings THE HAMMOCK SLING HAMMOCK 6 PRODUCT THA6 S HAMMOCK PRODUCT THA S THA6 M THA M THA6 L THA L THE HAMMOCK SLING IS IDEAL FOR MOST TRANSFERS WHICH CORRESPONDS TO THE NEED OF ABOUT 80 OF ALL PATIENTS THE HAMMOCK 6 HAS SIDE STRAPS FOR ADDED SECURITY AND TIGHTENED HEAD SUPPORT AREA BOTH HAMMOCK SLINGS ARE EXCELLENT FOR BATHING Our most universal sling the Hammock sling is a mesh type material that dries quickly but is soft and pliable The sling has an incorporated head support and a unique strap system that keeps the patient secure in the sling A special polyester fabric in the seat area helps to reduce friction and makes the sling easy to place around a patient in a chair without lifting or remove the patient The patient may be transferred in a seated semi reclined or fully reclined position Best
77. iption 10 3 1 3 Dimensions 10 3 1 4 Definition of product family 12 3 1 5 Functional purpose of the device intended use 12 3 1 6 Variants of the device 12 3 1 7 Records of significant changes to the device design 12 3 2 Use information 12 3 2 1 Advertising Warning 12 3 2 2 Intended patient population and medical condition 12 3 2 3 The reasonably foreseeable medical conditions is not be used 12 3 3 Market information 13 3 3 1 Warranty 13 3 3 2 Photograph of product and use 14 3 3 3 Brochure advertising marketing claims 14 3 3 4 Packaging specifications transport and storage conditions 14 v BEID 2 v ERIT V4 serie Technical file 3 3 5 Details of product labelling instructions for use and other literature 14 3 3 6 User and Technical Manuals 14 4 Product Specification 15 4 1 General description of each of the functional parts components 15 4 1 1 Bill of Materials 15 4 1 2 Mechanism 15 4 1 3 Accessories and other devices or equipment 16 4 1 4 Functional characteristics and technical specifications for the device 16 4 2 General Description of electrical components 17 4 2 1 Technical specifications of batteries 17 4 2 2 Technical specifications of charger 18 4 2 3 Technical specifications of motors 19 4 2 4 Control circuit plans 20 4 3 Design and production documentation 20 4 3 1 Calculation notes scoop of wo
78. isinfection Cl 44 Intermption of The Power Supply Cl 49 Abnormal Operation Fauit Condition Cl 52 Impact C 55 Components and General Assembly Cl 56 Overheating Test Cl 57 9 1 Induced Dielectric Strength Test on Transformer Clauses 57 9 2 Crecpagc Distance and Air Clearance Cl 57 10 Construction and Layout CL 59 Enclosure Ball Pressure Test Clause 59 2 b 1329800 15 ad BEID 59 IMEIHCAL INC Voyager Portable Technical File 016 BHM MEDICAL INC HIS ek AHA 3d UL GUI To KA nu ON WIIN PHE E Gol 3 aa O C99 O b Dei co or em aee yA 31138Y er TEL w r ie Y HIM Meci al ne 1253600 Elise dgicial ficos SPORT AE H 1729000 U QUE 60 bd lk Pe i r rl ER ou hs S3NH3 X3 SALUT 3MITV NO M Mid Dan PT 03 JEU 14 47 FAX 131996522419 03 07 BHM 35K sen 1 Mon Sep 09 07 15 42 2002 gt Lilet MEINCAL INC Y BHR Voyager Portable Technical File 03 07 D JEU 14 48 FAX 18198652249 BHM MEDICAL INC 1481017 Chargeur 700 15500 szh 1 ri Nov Ol 04 57 09 2002 BHU MEDICAL INC Ctorgeur 700 15500 SCH d U UNIVERSE CLASSE 1 CHARG JONATHAN BEYOIT r HEATSINK HOTT afi 2 48 RECORT 1844401223500 DEOUECT 1095670 Elali 61 wy MEINCAL INC BHM Y ces Voyager Portable Technical File Y 03 07 03 JEU 14 48 Faz 18195882249 BHM MEDICAL INC 4
79. its Ratings 3 15V dc Mountings Securely soldered to po board 1329500 14 ad BEID 58 IMEIHCAL INC BEM Voyager Portable Technical File Y cars 03 07 D JEU 14 47 Faz 18195882249 BHM MEDICAL INC 121015 MASTER CONTRACT 184445 REPORT 1329600 Page No 15 PROJECT 1329600 Date Issued October 4 2002 ss eee e M M M ss TESTS REPORT Y dition 1 Project 1320600 The following tests were performed on VOYAGER model V420 and battery Charger model 700 15500 the sample was vun Dame for lhe worst conditions Tests were performed according to the test requirements ot IEC 601 1 1988 CAN CSA C22 2 No 601 1 M90 AMI AMD UL Standard 2601 97 The following tests have been performed with satisfactory results as per Std C22 2 No 601 1 and UL 2601 1 Details of these results are kept in the CSA Eastern Rezian Principal file General Requirements Cl 1 Humidity Clause 4 10 Classification Cl 5 Marking Cl 6 Label Rub Test Clause 6 1 z Power Input Cl 7 Requirements Related to Classification Cl 14 Enclosures and Protective Covers Cl 14 Separation CL 17 Contimons 1 sakage Current CL 19 Dielectric Strength Cl 20 Mechanical Strength Cl 21 Rough Handling of Transportable Equipment Clause 21 6 Surfaces Corners und Edges Cl 23 77 Stability CL 24 Excessive Temperature Cl 42 Fire Prevention C1 43 Overflow Spillage Leakage Humidity Ingress of Liquids Cleaning Sterilization D
80. k The structure forms a box 164mm x 140mm wide by 124mm high Other mechanical parts are fixed to this frame The frame and steel parts are protected against rust by a zinc plated treatment Aluminium parts are protected by heredite or anodize plated treatment Displacement Vertical up down drum The motor ELVI without gearbox drives a 30 teeth worm gear double tread The worm gear drives a shaft on which lies a worm This worm drives a second worm gear directly attached to the drum The total obtained ratio is 375 1 Strap The strap is a threaded nylon that can hold up to 2727kg 60001bs Section 49mm x 1 2mm thick Displacement Horizontal left right The motor ELVI with integrated gear box drives a spur gear that drives two idlers Those idlers directly drive the wheel The wheels are made of plastic over molded on ball bearings Wheels are fixed on trolley with spring pins Steel trolley is fixed to the frame by three interlocks and secured with another interlock and a M5 screw v Ely 15 BHR S Voyager Portable Technical File dd End of strap stopper Up down In the unit a limit switch is attached on a steel blade sensing the double thickness of the strap This indicateds the higher position of the strap The lower limit is sensed when the drum tries to roll the strap into the wrong direction This will activate the switch and stops the motor 4 1 3 Accessories and other devices or equipment See anne
81. ks 1441 Risks connected with for example resistance stability and moving analysis parts applied Yes 2 Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices taking account of technical progress and of the means available for limiting vibrations particularly at source unless the vibrations are part of the specified performance Yes 3 Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted taking account of technical progress and of the means available to reduce noise particularly at source unless the noise emitted is part of the specified performance Yes Voyager Portable Technical File 30 RHM Voyager Portable Technical File DE DER WE com and pneumatic energy supplies which the user has to handle must be designed and constructed in such a way as to minimize all possible risks Yes 5 Accessible parts of the devices excluding the parts or areas intended to supply beat or reach given temperatures and their surroundings must not attain potentially dangerous temperatures under normal Use N A 12 8 Protection against the risks posed to the patient by energy supplies N A or substances 12 9 The function of the controls and indicators must be clearly specified Yes on the devices 13 Information supplied by the manufacturer 13 1 Each device
82. less they are intended To be placed in the teeth in which cast they are in Class Ila To be used in direct contact with the heart the central circulatory system or the central nervous system in which case they are in Class Ill To have a biological effect or to be wholly or mainly absorbed in which cast they are in Class Ill Or to undergo chemical change in the body except if the devices are placed in the teeth or to administer medicines in which case they are in Class 111 N A 3 1 All active therapeutic devices intended to administer or exchange energy are in Class lla unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way taking account of the nature the density and site of application of the energy in which cast they are in Class IIb All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb or intended directly to influence the performance of such devices are in Class llb Non active 3 2 10 Active devices intended for diagnosis are in Class Ia If they are intended to supply energy which will be absorbed by the human body except for devices used to illuminate the patient s body in the visible spectrum f they are intended to image in vivo distribution of radiopharrnaceuticals If they are intended to allow direct diagnosis or monitoring of vital physiol
83. ly no matter what height BEID 108 BHR KR Voyager Portable Technical File LAI dd SLING SPECIFICATION SLING SIZING SMALL MEDIUM LARGE SUGGESTED 20 46 kg 46 95 kg 95 250 kg WEIGHT 45 100 Ibs 100 240 Ibs 240 550 Ibs HEIGHT Rec era 6 PRODUCT NUMBERS TYPE OF SLING HAMMOCK HAMMOCK6 QUICKFIT HYGIENIC WALKING BAND THA S THA6 S TIR S THY S TEM S TST S M THA M THA6 M TIR M THY M TEM M TST M L THA L THA6 L TIR L THY L TEM L TST L XL TST XL SLING CARE Wash and dry at medium temperature maximum 60 Celsius Use mild soap Do not bleach SLING SPECIFICATIONS SPECIAL SLING SIZING SMALL MEDIUM LARGE BARIATRIC SUGGESTED 20 46 kg 46 95 kg 95 250 kg 453 kg WEIGHT 45 100 lbs 100 240 lbs 240 550 Ibs 1000 Ibs SUGGESTED 120 150 cm 151 180 cm 181 cm HEIGHT 4 11 b 5 11 6 PRODUCT NUMBERS v BHR 109 Voyager Portable Technical File M TOC M ONE SIZE ONE SIZE ONE SIZE L TOC L E E ONE SIZE XL SLING CARE Wash and dry at medium temperature maximum 60 Celsius Use mild soap Do not bleach Do not dry clean Appendix 4 1 3 c KWIKtrak For more information consult the Kwiktrak Installation Guide of BHM Medical WOOD BEAM INSTALLATION 2 X 6 WOODEN REAM 2 x6 MINIMUM CEILING SHEET ROCK CC CEILING PLATE 42
84. m x 131 5mm long without worm shafl Mounting Secured by screws and lock washer to chassis A Rotor aminated steal 55 mm dia hy 38 mm high Mounting Crimp to the shaft B Rotor Winding Enamelled copper wire class H UL C Rotor to winding Ineulation 1 layer of Isotherm 0 25 mm thick Class F 146 C D Spacer material PSU 2010 1329806 3 8d BEIS 52 wy MEINCAL INC BH Voyager Portable Technical File 03707 03 JEU 14 44 FAX 18199852240 BHM MEDICAL INC giang MASTER CONTRACT 184445 REPORT 1329600 Page No 9 PROJECT 1329600 Date Issucd October 4 2002 a E Collecinr Copper 23 diam long r Brush Carbon composition mourileu yn spring Dimensions 5x8 x 12 mm G Brush holder Later 4 C 30 Hi Motor leads Gartified TEW 105 C N 18AWG connected by certified 2 pins AMP connectar 1 Motor leads connection to windings crimping MATERIAL TYPE STIPPLIFR CERTIFICATION DESCRIPTION WINDING COOPER THENVEX INVEX CEI WIRE UL E45523 ROTOR WINDING ISOTERM ISOCOM PEIP MYLAR E93687 INSULATION DUPONT POLYESTER FILM E93687 BRUSHHOLDER LATI EXPORT T ATER UL E54080 ERI SPACER POLYSULFONE RESIN BASF PSU 2010 F41471 PSU2019 CABLE PVC ROTA CAVI ACCORDING TO THE CEI NORM 2020 DAT 41225 ISULATION OF THE PHENOL RESIN WITH ACCORDING TO UL COMMUTATOR GLASS MO V 14 DC Mutor Accepted Horizontal Motor Manufacturer ELVI MOTORI ELETTRICI SRL Typ
85. me of batteries depend on the duty cycle of use see Technical specifications of batteries section 4 2 1 The lifetime may be more if a general maintenance and inspection according to the manufacturer instructions at 10 000 cycles permit this 10 000 cycles usually correspond at 3 years of normal use v BHM 6 RHR V4 serie Technical file Y comes 2 6 Quality Assurance procedures and certificate See annex 2 6 SGS Certificate of ISO 9001 1994 accreditation 2 7 Post Market Surveillance 2 7 1 Complaints and incidents reported Available at BHM Medical 2 7 2 Advisory notices and recalls Available at BHM Medical 2 7 3 Competent authorities See annex 2 7 3 Competent authorities for Europe v BHM 7 Ska VEUT 3 Description of Product 3 1 General Description 3 1 1 Description of product TRACK LIFT SPECIFICATIONS CHARACTERISTICS Weight kg Lifting capacity kg Soft start amp stop movement SAFETY FEATURES Emergency lowering device A Current limiter 8 emergency stopping device Emergency brake TECHNICAL SPECIFICATIONS CSA UL amp CE approved amp respect EMI standards Frame Vertical displacement speed Vertical axis motor Horizontal displacement speed Horizontal programmable speeds Horizontal axis motor BATTERY MODEL SPECIFICATIONS Rechargeable sealed lead acid Clip on charging system Battery autonomy with load of 75 kg Visual amp audible low battery indica
86. mine if it is acceptable or unacceptable according to the standards v GI 38 lt gt BHW Voyager Portable Technical File 3 6 Risk reduction stage 6 Made To reduce the risk by security measures a Directs conception Intrinsic Yes b Indirects protection Protection Yes c Descriptives Notice Yes d By redefinition of the previous use Notice Yes 3 7 Others dangers generation stage 7 Made No To determine if the reduction had introduce new risks 3 8 Verification if all danger evaluated Made Yes 3 9 Results of the risks analysis on table In technical Yes file 4 Revision of the risks analysis if new facts In the Yes conception procedure This text don t reproduce the directive but to refer at this v GE 39 ELA d Voyager Portable Technical File EUA VW com Risk analysis Characteristics Identification Product Ceiling Lift By presences Fonction Date 5 ao t 2002 Family Voyager R al Pedneault ing Jun R amp D Place BHM Model V4 Equip R amp D No V4rev2 Version V4 and V420PLUS Envisaged use User Medical personnel and residents Necessary Formation BHM Medical formation Utilisation Environment Institutionnal and residential Installation carried out by User The device is it in liaison with the patient or another person Patient sling and user Which are the materials and the components of the device Plastic and al
87. must be accompanied by the information needed to use See labels Yes it safely and to identify the manufacturer taking account of the and training and knowledge of the potential users manuals This information comprises the details on the label and the data in the instructions for use As far as practicable and appropriate the information needed to use the device safely must be set our on the device itself and or on the packaging for each unit or where appropriate on the sales packaging If individual packaging of each unit is not practicable the information must be set our in the leaflet supplied with one or more devices Instructions for use must be included in the packaging for every device By way of exception no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions 13 2 Where appropriate this information should take the form of Symbols Yes symbols Any symbol or identification colour used must conform conform to the harmonized standards In areas for which no standards exist with the symbols and colours must be described in the documentation medical supplied with the device standards 13 3 The label must bear the following particulars See labels a The name or trade name and address of the manufacturer For devices imported into the Community in view of their distribution in the Community the label or the outer packaging or instructions
88. n particular A general description of the product including any variants planned Design drawings methods of manufacture envisaged and diagrams of components sub assemblies circuits etc The descriptions and explanations necessary to understand the above mentioned drawings and diagrams and the operations of the product The results of the risk analysis and a list of the standards referred to in Article 5 applied in full or in part and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full n the case of products placed on the market in a sterile condition description of the methods used The results of the design calculations and of the inspections carried out etc if the device is to he connected to other device s in order to operate as intended proof must he provided that it conforms to the essential requirements when connected to any such device s having the characteristics specified by the manufacturer The test reports and where appropriate clinical data in accordance with Annex X The label and instructions for use Requirements of EN 1441 Risks analysis applied Yes Yes Yes Yes N A Yes Yes Yes The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post production phase and to implement appr
89. ndant on the depth of discharge in each cycle More the batteries are drained the shorter their life span The lifte of the batteries is also related to such factors as varying temperatures and rest periods between charge and discharge Graph 1 Number of recharges vs Depth of discharge 500 1000 1500 2000 2500 3000 ES o S a S o gt E E S t Charge discharge cycles Graph 1 illlustrates the relationship between the discharging depth and expected battery life LLL 17 S BHM Voyager Portable Technical File If you drain the batteries until they beep every time you can expect the batteries to fully charge only 600 times Graph 2 Number of lifts vs lift load n o 3 E 2 z Number of lifts vs Lift Load 100 Weight Ibs Indicator Lights The lift and the charging system have many indicator lights It important to understand their significance for use and comprehension of the lift Green light Operating the lift Low batteries The lift is on and ready to use Yellow States of batteries light o In process of charging batteries Charging done batteries charged Red light Maintenance Maintenance required by your local representative Lift started by service mode Charging Turn on Charger on indicator green light Clip on charging Turn on Clip on charging station station indicator on green light
90. ogical processes unless they are specifically intended for monitoring of vital physiological parameters where the nature of variations is such that it could result in immediate danger to the patient for instance variations in cardiac performance respiration activity of CNS in which case they are in Class IIb Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices or which directly influence their performance are in Class IIb Non active 32 11 All active devices intended to administer and or remove medicines body liquids or other substances to or from the body are in Class lla unless this is done in a manner That is potentially hazardous taking account of the nature of the substances involved of the part of the body concerned and of the mode of Non active v GI 26 lt gt BHW Voyager Portable Technical File application in which case they are in Class IIb 3 3 12 All other active devices are in Class I Non active 4 1 13 All devices incorporating as an integral part a substance which if used separately can he considered to be a medicinal product as defined in Article 1 of Directive 65165 EEC and which is liable to act on the human body with action ancillary to that of the devices are in Class III N A 4 2 14 All devices used
91. opriate means to apply any necessary corrective actions taking account of the nature and risks in relation to the product He shall notify the competent authorities of the following incidents immediately on learning of them Any malfunction or deterioration in the characteristics and or performance of a device as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his stare of health Any technical or medical reason connected with the Procedure previous Yes v GI 22 S BHW characteristics on the performance of a device for the reasons referred to in subparagraph I leading to systematic recall of devices of the same type by the manufacturer referred to in Annex IV V or VI the declaration of conformity referred to in the abovementioned Annexes forms a single declaration As regards the declaration based on this Annex the manufacturer must ensure and declare that the product design meets the provisions of this Directive which apply to it 5 With products placed on the market in sterile condition and Class N A I devices with a measuring function the manufacturer must observe not only the provisions laid down in this Annex but also one of the procedures 6 1 Where this Annex is applied in conjunction with the procedure Yes This text don t reproduce the directive but
92. principally with wounds which have breached the dermis and can only heal by secondary intent Arein Class Ila in all other cases including devices principally intended to manage the microenvironment of a wound 2 1 5 All invasive devices with respect to body orifices other than surgically Non invasive devices and which are not intended for connection to an active invasive medical device Are in Class I if they are intended for transient use Arein Class lla if they are intended for short term use except if they are used in the oral cavity as far as the pharynx in an car canal up to the car drum or in a nasal cavity in which case they are in Class I Arein Class IIb if they are intended for long term use except if they are used in the oral cavity as far as the pharynx in an ear canal up to the car drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane in which case they are in Class IIa All invasive devices with respect to body orifices other than surgically invasive devices intended for connection to an active medical device in Class lla or a higher class are in Class Ila 2 2 6 All surgically invasive devices intended for transient use are in Class lla Non unless they arc invasive ntended specifically to diagnose monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body in which case they are in Class III
93. quipment Technical measures are to be Certification laid down in accordance with point 1 in order to ensure a That the electrical equipment meets the expected mechanical requirements in such a way that persons domestic animals and property are not endangered b That the electrical equipment shall be resistant to non Yes mechanical influences in expected environmental conditions in such a way that persons domestic animals and property are not endangered Yes c That the electrical equipment shall not endanger persons domestic animals and property in foreseeable conditions of overload Yes This text don t reproduce the directive but to refer at this v GE 34 EI Voyager Portable Technical File DE ER WE com Appendix 2 2 3 a Directive 89 336 EEC Directive 89 336 EEC Electromagnetic Compatibility May 1989 Product V4 Clause Requirements Notes Verdicts 4 The apparatus referred to in Article 2 shall be so constructed See that requirements a The electromagnetic disturbance it generates does not annex III exceed a level allowing radio and telecommunications equipment and other apparatus to operate as intended Yes b The apparatus has an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as intended Yes The principal protection requirements are set out in Annex III 10 1 The conformity of apparatus with this Directive shall be certified by an EC declaration
94. r Portable Technical File THE HYGIENIC SLING THE HYGIENIC SLING IDEAL FOR TRANSFERRING TO THE TOILET IT ALSO PROVIDES AN EASY WAY TO CHANGE DIAPERS PRODUCT THY S THY M THY L This sling is excellent for changing incontinence pads or to transfer onto a toilet as it provides an open area from the middle of the back to the middle of the thigh The padding wraps around the patient s midsection and under each leg In order to use this sling the patient must have good muscle tone in their shoulders and upper body Fits all BHM ceiling lift models as well as the Ergolift mobile lift and Ergostand stand assist Available in sizes S MAL Weight capacity is 250 kg 550 Ibs Check with the patient s physician nurse or medical specialist before using this sling AN Do not use Hygienic sling on a patient who does not have good muscle tone in their shoulders and neck SLING DIMENSIONS HYGIENIC SLING PRODUCT THY SIZE SMALL MEDIUM LARGE v BHR CM IN 96 52 38 106 68 42 116 84 46 CM IN 83 82 33 88 9 35 93 98 37 CM IN 88 9 35 106 68 42 124 46 49 94 PHM Voyager Portable Technical File SLING SIZES AND PRODUCT NUMBERS SMALL MEDIUM LARGE CHEST SIZE 68 89 cm 27 35 Somen 35 89 107 cm 35 42 PRODUCT THY S THM COLOR CODE Red Yellow leen H Sling attachment to Carry Bar Always use the same colo
95. ratory 5 5 1 11 EE 5 1 1 7 battery fuse Oveload detector 15 emergency break high capacity Overload Mechanical breaking fall 9 5 vw Cibi 42 BERT Voyager Portable Technical File Y coos Appendix 2 5 2 a CSA Certificate V4 E CSA INTERNATIONAL Certificate of Compliance Issued to BHM MEDICAL INC 2001 Tanguay Magog QC JIX 5Y5 CANADA The products listed below are eligible to bear the CSA Mark shown with adjacent indicators C and Us A o Y 4 M PATA q p Issued by M Bfossoil Eng C US SE My Authorized by Alain Ste Marie Operations Manager PRODUCTS CLASS 8750 01 MEDICAL ELECTRICAL EQUIPMENT CLASS 8750 81 MEDICAL ELECTRICAL EQUIPMENT CERTIFIED TO U S STANDARDS Part A Patient lifter on ceiling track battery operated cord connected via battery charger VOYAGER series model V4 rated 24V de 15A maximum load 273 kg 6001bs and model V420 PLUS rated 24Vdc 15A maximum load 190 kg 4201bs 1 Type of protection against electric shock Internally Powered Battery 2 Degree of protection against electric shock BF 3 Degree of protection against ingress of water IP21 4 Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or wit
96. requires Risks analysis a Devices and accessories risks description and BHM Medical identification inc see tables Yes b List of eventual risk identification in 3 3 CSA Yes c An indication of the reduction risk method at acceptable Canadian levels Standards Yes d An identification that who made the risks analysis Association Yes 3 2 Qualitative and quantitative characteristics identification Made Yes stage 2 For the device or the accessories make a list of all characteristics could affect the security a Previsible using See Use and b Patient contact maintenance No manual c Material See Technical manual d Energy No e Substances No f Biological No g Sterile No h Patient environment No i Measuring No jp Data No k Others dispositifs or drugs No D Energy emissivity No m Environment sensibility No n Accessories See Yes accessories o Maintenance See Technical Yes manual p Computer program No q Stock condition No r Long term utilisation No s Mechanical load See manual t Life time factors N A u One use or reutilisable device Reutilisable 3 3 Identification of possible dangers stage 3 Made annex Yes List of potential dangers in normal condition or by fault C used annex C 3 4 Identification of relative risk for any danger stage 4 Made Yes For any identification dangers to estimate risks with available information 3 5 Risk acceptability stage 5 Made Yes For any risks to deter
97. rk 20 4 3 2 Bibliography and references 20 4 3 3 Material safety data description and physical properties of the materials 20 4 3 4 Specifications instructions and fabrication process 20 4 3 5 Special process instructions and inspections 20 5 Verification of product 21 5 1 Test records 21 5 1 1 Internal laboratory and engineering tests 21 5 1 2 Records methods and tests localization 21 Appendix 2 1 2 Directive 93 42 EEC Annex VII 22 Appendix 2 1 3 CE Declaration of conformity 24 Appendix 2 1 4 Directive 93 42 EEC Annex IX 25 Appendix 2 2 1 Directive 93 42 EEC Annex I Essential requirements 28 Appendix 2 2 2 Directive 73 23 EEC 34 Appendix 2 2 3 a Directive 89 336 EEC 35 Appendix 2 2 3 b Standard EN 12182 36 Appendix 2 2 4 Standard EN 1441 Risk Analysis 38 Appendix 2 5 2 a CSA Certificate V4 43 Appendix 2 5 2 b CSA Report V4 46 Appendix 2 6 SGS Certificate ISO 9001 1994 68 Appendix 2 7 3 National authority 69 Appendix 3 1 4 Identical models 72 Appendix 3 2 1 Extract of safety instructions advertisings and warnings 73 Appendix 3 3 3 Brochure advertising marketing claims 78 Appendix 4 1 1 V4 part list 82 Appendix 4 1 3 a Accessories 87 Appendix 4 1 3 b Slings 89 Appendix 4 1 3 c KWIKtrak 111 BHA W orm EE V4 serie Technical file 1 Introduction 1 4 Product identification General names 420PLUS V4 Serial name Voyager Family name Ceiling lift 1 2 Manufacturer and location
98. rt number E0006 Rating 24 Vdc 1 8A 30 Watts 260 RPM 1 0 N m Overall dim 63mm x 114mm long without reducer Mounting Secured by screws and lockwasher to chassis A Rotor Laminated steel 42 mm dia by 32 mm high Mounting Crimp to the shaft B Rotor Winding Enamelled copper wire class H UL see enclosed sheet D Rotor to winding insulation 1 layer of Isotherm 0 25 mm thick Class F 145 C D Spacer material PSU 2010 see enclosed sheet F Collector Copper 19 mm diam see enclosed sheet G Brush Carbon composition mounted on spring Dimensions 6 5x4 5x10 mm 19 EI e Voyager Portable Technical File IA VW cum K Brush holder Later 4 G 30 see enclosed sheet L Motor leads Certified TEW 105 C N 18AWG connected by certified 2 pins AMP connector M Motor leads connection to windings crimping 4 2 4 Control circuit plans See CSA report in appendix 2 4 2 b 4 3 Design and production documentation 4 3 1 Calculation notes scoop of work Available 4 3 2 Bibliography and references Available 4 3 3 Material safety data description and physical properties of the materials Available 4 3 4 Specifications instructions and fabrication process Available 4 3 5 Special process instructions and inspections Available v BH bi 20 eo BH Voyager Portable Technical File 5 Verification of product BHM Medical Inc Credentials FDA Registration 9681684 CE mark European Union Listing
99. s referred to in Article 1 2 a as specified by the manufacturer 4 The characteristics and performances referred to in Sections 1 2 Requireme OK and 3 must not be adversely affected to such a degree that the nts of EN clinical conditions and safety of the patients and where applicable 1441 Risks of other persons are compromised during the lifetime of the device analysis as indicated by the manufacturer when the device is subjected to applied the stresses which can occur during normal conditions of use 5 The devices must be designed manufactured and packed in such a OK way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer 6 Any undesirable side effect must constitute an acceptable risk when Yes weighed against the performances intended II REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7 Chemical physical and biological properties 71 The devices must be designed and manufactured in such a way as to Requireme guarantee the characteristics and performances referred to in nts of EN Section I on the General requirements Particular attention must 1441 Risks be paid to analysis The choice of materials used particularly as regards toxicity applied v Ely 28 S BHW and where appropriate flammability The compa
100. sed batteries may cause fire or explosion D EQUIPMENT WARNING LABELS gt INSPECT all precautionary labels on the equipment Order and replace all labels that cannot be easily read Operation READ SAFETY INSTRUCTIONS AND WARNING BEFORE ATTEMPTING TO USE THE V4 gt The unit will not lift or lower when in contact with the charger If the lift does not work gently pull on the red cord until you hear a click The green light should illuminate Hold the lift spreader bar with one hand at all times when near a patient gt B Bb BEFORE LIFTING THE PATIENT 1 Make sure the patient is confortable 2 Make sure the sling is not caught on any obstruction wheelchair brake or arm of the chair 3 If any of the above occurs lower the patient immediately and correct the problem Hold the lift spreader bar with one hand at all times when near a patient Emergency Stop Red Cord Do not pull red cord forcefully If the cord is pulled too forcefully the lift may becom inoperable Emergency Lowering Feature v Elib 75 BEIRA e Voyager Portable Technical File Sick VW com Only to be used in case of an emergency Chargement de la batterie N DO NOT operate the charger unit with a damaged cord or if the unit has been dropped or damaged
101. ssible on an accompanying notice Yes b The manufacturers or brand name or trademark should be clearly printed on the electrical equipment or where that is not possible on the packaging Yes c The electrical equipment together with its component parts should be made in such a way as to ensure that it can be safely and properly assembled and connected Yes d The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards set out in points 2 and 3 of this Annex is assured providing that the equipment is used in applications for which it was made and is adequately maintained Yes 2 Protection against hazards arising from the electrical equipment CSA C22 2 Measures of a technical nature should be prescribed in accordance no601 1 with point 1 in order to ensure approved see a That persons and domestic animals are adequately protected certificate against danger of physical injury or other harm which might be caused by electrical contact direct or indirect Yes b That temperatures arcs or radiation which would cause a danger are not produced Yes c That persons domestic animals and property are adequately protected against non electrical dangers caused by the electrical equipment which are revealed by experience Yes d That the insulation must be suitable for foreseeable conditions Yes 3 Protection against hazards which may be caused by external See CSA influences on the electrical e
102. teral braces if the distance between the suspended ceiling and anchors are more than 18 inches Parallel AVCHD MOVING AV OID MOVING v AMO MOVING e A e E DP 4 CLL Dr M 474779 ULLA APA a e ele e ee M e ale a ee Kgl dd CE UNG Voyager Portable Technical File Threaded rod Extendable clamping collars clamping collars SUSPENCED CULINS RACK JOINT BETWEEN TWO TRACKS JOINT BRACKET Spring pin tool Spring pins 113 SE o Voyager Portable Technical File Lidil jT Spring pins H TRACK HT TRASK MIDDLE OF THE JOINT BRACKET 9 JOINT BRACKET mk A E LOCKING TOOL 005 11100 ou EA TAA SECURE 114 Voyager Portable Technical File Ea Y mem RI 115 Voyager Portable Technical File Exchanger 14 1 5 SAC Turntable 116
103. tibility between the materials used and biological tissues cells and body fluids taking account of the intended purpose of the device Yes N A 7 2 The devices must be designed manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport storage and use of the devices and to the patients taking account of the intended purpose of the product Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure N A 7 3 The devices must be designed and manufactured in such a way that they can be used safely with the materials substances and gases with which they enter into contact during their normal use or during routine procedures if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use N A 7 4 Where a device incorporates as an integral part a substance which if used separately may be considered to be a medicinal product as defined in Article 1 of Directive 65 65 EEC and which is liable to act upon the body with action ancillary to that of the device the safety quality and usefulness of the substance must be verified taking account of the
104. to do refer at this v GE Voyager Portable Technical File 23 BEM Voyager Portable Technical File Zoe Y comm Appendix 2 1 3 CE Declaration of conformity ga iM CE DECLARATION OF CONFORMITY COMPANY BHM MEDICAL INC ADDRESS 2001 Tanguay Magog Qc Canada J1X 5Y5 TELEPHONE 819 868 0441 FAX 819 868 2249 HEREBY DECLARE THAT PRODUCT Voyager V4 Patient Celling Lift MODEL Voyager 420PLUS V420PLUS V4 ARE ACCORDING TO THE STANDARDS LISTED BELOW AMONG OTHERS NUMBER TITLE CAN CSA C22 2 Medical Electrical Equipment No 601 1 94 Part 1 General Requirements for Safety No 601 2 94 Part 2 Collateral Standard Electromagnetic Compatibility CISPR 11 19990 Limits and Methods of Measurements of Electromagnetic Radio Disturbance Characteristics of Industrial Scientific and Medical ISM Radio Frequency Equipment IEC 60601 1 Medical Electrical Equipment General Requirements For Safety IEC 801 2 1991 Electrostatic Discharge IEC 801 4 1988 Electrical Fast Transients EN 61000 4 3 1997 Radiated RF Immunity EN 1041 Terminology and Symbols EN 1441 Medical Apparatus Risk Analysis EN 12182 Technical Aids for Disabled Persons AND IS ACCORDING TO THE FOLLOWING RULES AND GUIDE LINES NUMBER TITLE 93 42 CEE Medical Rules and Guide Lines 93 68 CEE C E Marking Guide Lines SIGNATURE DATE NEE A NAME BERNARD J HAMEL c a MADE IN VICE PRESIDENT MAGOG QUEBEC CANADA Ga li 24 Y comm ELA e Voyager Portable Te
105. tor A Battery protection function Charge input Lift cannot return to charger with load Return to charge function on handset STRAP SPECIFICATIONS Length Automatically stops unit if twisted UNIT COMPOSITES Mechanical structure high strength steel v BEID V4 serie Technical file V4 11 5 kg batteries include 200 kg 440 lbs YES Manual electric YES Centrifugal YES Steel 1000kg tested 60 mm sec 40mm s at 200kg 24 VDC 1 12 HP 150 mm s 100mm s 150mm s 200mm s 250mm s 24 VDC 1 12 HP 2X12VDC 4 5Ah YES Up to 100 transfers YES YES 0 5 A max 100 to 240 Vac 50 to 60 HZ YES Optional 2 3 m 1500kg tested YES YES 1000kg tested Y EE V4 serie Technical file MEDICAL INC Dimensions Length 38 cm Width 25 cm Height 18 cm Cab VO plastic fire retardant YES Rail T66081 T5 high extruded aluminium amp YES baked paint coated DESCRIPTION OF EQUPMENT V4 Lift Unit The lift unit is a steel frame based system driven by a gear reduced high torque motor OPERATING FEATURES Lifting capacity 200 kg 440 lbs Average weight 11 5 kg 25 Ibs batteries included Electronic soft start and soft stop motor control Emergency lowering device Emergency stopping device Current limiter for circ
106. tra Sturdy and hips M Positions patient properly in a chair no manual Positioning Handles positioning needed provides a safe way for caregiver to turn the patient Strong and durable umbrella shape with 4 hooks White powder coated steel frame provides ample room for the patient v Elali 103 ERA Voyager Portable Technical File DE ER VW cum T Very strong and durable ensures patient safety gt 250 kg 550 lbs lifting capacity Easy to clean and care for gt Machine washable Fits 95 of patients Onesize I Lilo 104 S BHM Voyager Portable Technical File THE UNIVERSAL STRETCHER The Universal stretcher sling is specifically designed to transfer a person in a prone position The sling is made of polyester nylon net material that is easy to manipulates and allows for air circulation The frame can be assembled around the patient once the sling has been installed which makes the installation faster and easier The buckles at the headrest and footrest offer the flexibility to adjust to the patient s comfort level Can be used with Voyager Portable Voyager Series and the Ergolift Mobile Floor Lift SLING DIMENSIONS UNIVERSAL STRETCHER PRODUCT 443500 Ly p D Es e E a A B CM IN CM IN ONE SIZE 73 6 29 CHARACTERISTICS BENEFITS gt Soft polyester nylon net Specially designed fabric is ultra soft dries quickly f
107. uipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with vxygen or nitrous oxide 5 Mode of operation Continuoug APPLICABLE REQUIREMENTS CSA Standards CAN CSA C22 2 No 0 M9l General Requirements Canadian Electrical Code Part I CAN CSA C22 2 No 601 1 M50 Medical Electrical Equipment Part I General Requirements for Safety CAN USA C22 2 No 601 181 94 Supplement No 1 94 to CAN CSA C22 2 No 601 1 M90 Medical Elechical Equipurmut Part 1 General Requirements for Safety CAN CSA C22 2 Nu 601 1 1998 Amendment 2 to CAN CSA C22 2 No 601 1 M90 Medical T Electrical Equipment Part l General Requirements for Safety IEC Standards IEC 60601 1 1988 Medical Electrical Equipment Pam 1 General Requirements foi Safety IEC 60601 1 1991 Amendment No 1 1991 Amendment 1 to 60601 1 1988 TEC 60601 1 1995 Amendment No 2 1995 Amendment 2 to 60601 1 1988 UL Standards UL Standard No 2601 1 97 2 Edition Medical Electrical Equipment Part I General Requirements for Safety Subject to the following conditions 1 The equipment has not been investigated for the protection against hazards of explosions in medically used rooms 2 Units provided with other than CSA Certified power supply cord sets are Certified without the power supply cord set as components uly 3 Evaluated to IEC CSA 601 1 Amendment 2 excluding requirements for Biocompatibility Clause 48 and Procrammable Electronic Systems TEC
108. uit protection in case of overload Safety device that stops the motor to lift when batteries are too low Lifting speed 6 cm s 2 3in s 3 5cm s 1 6in s in full capacity Horizontal displacement speeds 10 15 20 and 25 cm s Speed by default 20cm s 6in s Horizontal axis motor 24VDC at 62 watts and vertical axis motor at 110w Emergency brake in case of mechanical failure Operates on the same principle as a car safety belt mechanism Strap length up to 2 3m 90in tested for 1360kg 2998 CSA No 601 1 UL No 2601 1 and CE conformity Respect EMI standards ISO 10535 What s included ITEM QTY VA Lift Batteries inside unit Clip on charging station Hand control Spreader bar Power cord 8 mm Allen key User Manual i lr IR R nin v BHM 9 BRIN V4 serie Technical file 3 1 2 Parts description Part description Door i Charging station Manual lowering Charger 8 mm Allen key Strap Spreader bar On green light Up Hand control Red light for Let service Right Down button do Return to Red cord for Programming mode charge emergency stop Up button PROG Notes the yellow light charger flashes while charging and illuminates when charge is finished the green light on illuminates once the lift is on and ready for use the green light flashes when the batteries are low The red ight service
109. uminium Influences of the environnement on Transportation Storage Aspersion A Electrical alimentation Batterie device Ambient temperature range of 40 C to 70 C Relative humidity range of 1096 to 10096 Atmospheric pressure range of 50 to 106 Kpa Which are the specification and the restrictions of the accessories available Use in combination with medical accessories BHM only Maintenance carried out by The user Visual inspection and batterie recharge Tthe specialist technician Full maintenance by BHM or autorised technician With which forces mechanics the device will be used 440lbs 200Kg Which is the lifespan estimated of the device 10 000 cycles 3 years by respecting preventive maintenance vw Elali 40 PHM Voyager Portable Technical File Xn WV cma Risk Parameters Parameters Level Weighting Effect Small wounds 1 E Serious wounds 5 Death 9 Improbable 0 Probability of event Low will probably not occur 1 P Average can occur 3 Will frequently occur 5 Averting Danger Possible under certain circumstances 0 A Barely possible 1 Risk Evaluation TAble Probability 1 3 5 Low Average Frequently 2 3 4 5 6 5 6 7 8 9 10 Serious 9 i gt A 0 1 0 1 0 1 Circumstance Barely Circumstance Barely Circumstance BArely Averting Danger Acceptable vw Eli 41 BHW e Voyager Portable Technical File Sick VW com
110. ur loop on the shoulder straps for both sides of the sling Use the same colour loop on the leg straps for both sides of the sling CHARACTERISTICS BENEFITS gt Open area from above waist to Excellent for toileting easy access to pants diapers or for thighs cleaning sling supports from both the upper body and lower body gt Padded and quilted Polyester Specially designed fabric is ultra soft and long lasting provides Nylon extra comfort for the patient fabric is easy to move gt Padded waist band with belt Easy to install on a seated patient extra padding under the arms keeps the patient comfortable during the transfer padding around entire waist reduce pressure gt Strong Nylon straps with Patient can be seated forward straight or semi reclined and fully positioning loops reclined legs can be raised or lowered slightly provides flexibility for many types of patients excellent for ERGOSTAND lift Special Leg Strap design Leg straps are fully padded to reduce pressure legs can be ositioned together semi open and open Positioning Handles Patient can be transferred to any position from any position positions patient properly in the chair no second adjustment needed transferring from lying position to seated position is fast and easy provides a safe place for caregiver to turn the patient gt 550 lbs Lifting capacity gt Machine washable Easy to
111. used in any situation from operative room spinal or postoperative orthopaedic care to fallen injured patient Clinical pathology gt Sanitary Easy to clean disinfect v BHM 102 BEM Voyager Portable Technical File Xn VW cua THE BED POSITIONING SLING This sling is designed to reduce the risk of injury to caregivers by assisting with patient positioning and adjustments in bed The sling is placed in bed as part of the bedding The straps allow the caregiver to easily lift the patient just enough to reposition and lower The polyester net material breathes easily while is soft to the touch Loops on the straps near the head provide adjustment for head position May also be used for lateral transfers Fits all BHM ceiling lift models as well as Ergolift mobile list One size only Weight capacity 250 kg 550 lbs SLING DIMENSIONS BED POSITIONING SLING PRODUCTZTPO PRODUCT SLING TPO FE eee Sze CM IN CMN CM IN ONE SIZE 218 85 89 35 103 40 CHARACTERISTICS BENEFITS Specially designed fabric is ultra soft and long Soft Polyester Nylon net lasting gently hugs the patient fabric is easy to move easy to install in bed d Patient position can be adjusted slightly Strong Nylon straps with positioning depending on need provides flexibility for loops comfort Excellent for heavy patients extra room for thighs Ex
112. utilis cette fin Ce certificat de SGS SCI qui il doit Are renvoy sur Member of the SGS Group Soci t G n rale de Surveillance BEIS 68 wy METHCAL INC BHR P Voyager Portable Technical File WE com Appendix 2 7 3 National authority COUNTRIES NAMES E mail Web site PHONE ADDRESSES FAX AUSTRIA Federal AIMD Dr W Nihil Abt VIII A 22 Ph 43 1 711 00 4206 Ministry of Social Ecker Dr Medical Ph 43 1711 00 4487 Security and MDD Renhardt Devices Medizinp Ph 43 1 711 00 4492 Generations IVD Ing Gutruf rodukte Radetzkystrasse Fax 43 1 711 00 4217 2A 1031 Vienna Fax 43 1 715 73 12 BELGIUM AIMD Mr P meddev afigp fg Vesalius Building Ph 32 2 210 63 58 Federal Public Bauwin ov be Service MDD Rijksadministratief Fax 32 2 210 49 01 Health Food Chain Mrs S www afigp fgov b Centrum Safety and Mignon e B 1010 Brussels Environment Directorate General Public Health Protection Medicinal Products Medical Devices Unit BELGIUM IVD Dr JL Jean Louis Pasteur Ph 32 2 642 55 27 Institut Scientifique Libeer Claude Libeer ip Rue Juliette de Sant Publique f fgov be Wytsman 14 Fax 32 2 642 56 45 1050 Bruxelles DENMARK Mr H K hka dkma dk Frederikssundsvej Ph 45 4488 9111 Danish Medicines Andersen 378DK 2700 Ph 45 4488 9265 Agency Br nsh j Fax 45 4488 9314 FINLAND AIMD Mr Petri Nihil Mannerheimintie Ph 358 9 4733 4249 Medical Devi
113. ve for national specific labelling 3 3 6 User and Technical Manuals See your local representative for national version Clili 14 wy METHCAL INC BEIRA Voyager Portable Technical File Xr WV cua 4 Product Specification 4 1 General description of each of the functional parts components 4 1 1 Bill of Materials See annex 4 1 1 4 1 2 Mechanism Model consists of a 24Vdc battery operated patient lifter module installed on a rail All components are enclosed in on combustible enclosure without ventilation opening Lifter can be displaced manually or it is moved by a motor on the rail Flame class rating for both plastic parts white and blue plastic cab Material V 0 Class Rating Test method UL 94 All electrical parts are enclosed in non combustible V 0 plastic enclosure and metal chassis without ventilation opening Emergency Switch S5 Certified CSA UR type pullchain switch DC Motor vertical movement Manufaturer ELVI MOTORI ELETTRICI SRL Type Fully enclosed no ventilation opening permanent magnet class A Rating 24V dc 1 1A 110W 4000RPM 0 3N m Mounting Secured by screws and lock washer to chassis DC Motor Horizontal movement Manufaturer ELVI MOTORI ELETTRICI SRL Type Fully enclosed no ventilation opening permanent magnet provided with integral reducer Rating 24V dc 1 8A 30W 260RPM 1 0N m Mounting Secured by screws and lock washer to chassis Frame Frame is made of steel 2 64mm thic
114. x 4 1 3 4 1 4 Functional characteristics and technical specifications for the device HOW A VOYAGER SERIES IMPROVES EFFICIENCY AND CARE Emergency Stop Red Cord The emergency stop can be activated at any time to stop the functioning of the lift Emergency Lowering Feature In the event of an electrical or functional failure the V4 has an emergency manual lowering feature If the lift malfunctions when a patient is being transferred the emergency lower device provices a safe way of lowering the patient onto a chair or a bed Emergency Brake The emergency brake is made of a metal bar fixed to the drum v BHR 16 Voyager Portable Technical File In case of gear or motor breakage the centrifugal force created will block the bar against the frame Programmable Lift Mode Program The speed and height of the lift can be easily adjusted by the user while in the Program Service Mode Use the UP button on the hand control to select the parameters wanted Each push of the button will bring you to a different selection 1 beep Speed displacement 2 beeps Length of the strap 4 2 General Description of electrical components 4 2 1 Technical specifications of batteries e 2 rechargeable batteries of 12 Vdc 5 Ah e Provides up to 120 transfers with a load of 74kg 200lb and up to 70 transfers with its maximum load of 200kg 440Ib Life cycle number of charging cycles of the batteries is largely depe
115. y a motor on thc rail Major primary components 1 Enclogure Overall dimensions 400x260x 170 parts white and blue Unit cab is made of Baybleud FR 2000 while WH010639 This material is used for injection molding thickness of 2 70mm White part dimensions 400x260x170mm by 2 70 mm thick 2 Part of the Enclosure Unit cab is consisted also of Mamm 5200 blue color added U4MBS7047 BLUE 4 LDR Thie material is ueed for injection molding thickness of 2 0mm Blue part dimensions 400x260x55mm by 2 0 mm thick Flame class rating for both plastic parts white and hluefplastie cab Material V 0 Class Ralinp Test method UE 94 All electrical parts are enclosed in non combustible V 0 plastic enclosure and metal chassis without ventilation opening as per attached photograph 3 Printed Circuit Board 1 used Material Fiberglass 1 6 mm thiok rated V 0 Dimensions 55 mm by 146 mm Mounting Vertically mounted and secured to thc chassis by 5 screws 4 Batteries 2 used Power Backup Batteries ypiional Manufaemrer Wuhan Sota Enertech Ine Type Rechargeable gel cell sealed Cat N SA1250 Rating 12V de SAh Connection Both connected in series 5 Fuse Fl INT Certified UR Manufacturer Huss Type Glass cartridge 5 x 20 mm Cat N GMAIS Bann 154 123Vac Mounting inserted into fise clip om peh 6 Battery Blocking Diode D11 Type Silicon phenolic body Cat N 1N5401 Rating 3A 00V Mounting Soldered to peb

Download Pdf Manuals

Related Search

Related Contents

User manual Interroll Cart Pushback  Samsung DVDL100 User's Manual  Trampoline, actrice de la lutte contre l`illettrisme Les problèmes d  【JL23012】UNLIMITED スピードリミッターカットユニット - J  CMS Manual - Guardian Security  ROTAX MAX CHALLENGE BRASIL 2013    熱赤外サーモグラフィ装置を用いた劣化検出の有用性  Manual SPF-42 TTG  

Copyright © All rights reserved. Failed to retrieve file