Multi-Flo Model #1545-KT. Multi-Flo Model #1545-F

Transcription

1 Multi-Flo Model #1545-KT Multi-Flo Model #1545-F

2 Bio Compression Systems, Inc. MULTI-FLO Intermittent Pneumatic Compression Device Model #1C-1545-KT / #1C-1545-F INTRODUCTION The Multi-Flo Model #1545 Series is designed to provide two (2) distinctive modes of therapy: Model #1545-KT DVT This model is designed to provide Intermittent Pneumatic Compression for maximum prophylaxis against Deep Vein Thrombosis with the garments applied bilaterally over either the Calves ( Knee High-( K ), the Thighs, or both the Calves and Thighs ( T ). Model #1545-F DVT As an alternative mode of DVT prophylaxis, Intermittent Pneumatic Compression is applied instead through bi-lateral Foot garments at an increased flow rate, higher pressure and quicker cycle. The Models#1545-KTand #1545-F are specifically indicated for bilateral prophylaxis against Deep Vein Thrombosis (DVT) and NOT to be used as a treatment for existing DVT where it is specifically contraindicated. DVT prophylaxis should be applied continuously, around the clock at the factory pre-set pressures previously indicated elsewhere in this manual, dependent upon the application site, unless otherwise ordered by the attending physician. A less aggressive treatment schedule is more commonly prescribed by the physician post discharge in the home setting. TABLE OF CONTENTS Page Intended Use 2 Contraindications.2 Warnings, Cautions & Precautions..2 Symbol Definitions..3 Controls & Indicators...3 Pressure Override Adjustment..3 On-Device Labels.4 Electrical Specifications...4 Classification, Electrical 5 General Equipment Specifications 5 Unpacking Equipment...5 Intermittent Circulator - Sleeve / Garment Operating Instructions...6 Electromagnetic Compatibility (EMC).7 - Accompanying Documentation 8-9 Cleaning Instructions 10 Fuse Replacement.11 Packing, Shipping & Storage 11 Warranty / Customer Service 12 1

3 INTENDED USE When used with G T Knee/Thigh or G K Knee garments: Intended for prophylaxis of deep vein thrombosis When used with G F Foot Garments: Intended for prophylaxis of deep vein thrombosis Enhancement of venous and arterial circulation Prevention of venous stasis ulcers Assist in healing of cutaneous ulcers Reduction of acute and chronic edema Reduction of lower limb pain due to surgery or trauma Reduction of compartmental pressures CONTRAINDICATIONS Use of this device is contraindicated for patients with the following condition: Any local condition of the extremity that would interfere with its application, including, but not limited to: Dermatitis Immediately following vein ligature Gangrene Skin grafts Casts or splints Severe arteriosclerosis or other ischemic vascular disease Pulmonary edema Congestive heart failure Suspicion or confirmation of the presence of existing DVT Infections of the limb, including cellulitis without appropriate antibiotic coverage for at least 72 hours prior to treatment Presence of lymphangiosarcoma Inflammatory phlebitis or episodes of pulmonary embolism WARNINGS, CAUTIONS, PRECAUTIONS WARNING: DO NOT use in the presence of flammable anesthetics CAUTION: Federal law restricts this device to sale by, or on the order of, a licensed physician. CAUTION: Should the patient complain of increased pain, numbness or tingling, discontinue treatment immediately and contact the attending physician. CAUTION: High pressure should be set with caution on patients with peripheral arterial occlusive disease. 2

4 Pressure Gauge SYMBOL DEFINITIONS = REFER TO DOCUMENTATION BEFORE USING AND SERVICING = TYPE B APPLIED PART = CLASS II PROTECTION CONTROLS & INDICATORS MODELS # 1545-KT Male Kwik Connectors Pressure Gauge Lighted ON/OFF Switch Pressure Adjustment Knob Locking Knob MODELS # 1545-F Female Kwik Connectors Pressure Gauge Lighted ON/OFF Switch Pressure Adjustment Knob Locking Knob 3

5 ON DEVICE LABELS ELECTRICAL SPECIFICATIONS The Multi-Flo Model #1545 Series pump is equipped with a grounded Hospital Grade Plug. The plug is of the molded type, permanently attached to an 18 gauge, 10 long cable, secured through the pump casing with a Heyco strain relief bushing. DO NOT use unless a tag is attached to cable which reads the following: NOTICE: ATTACH ONLY TO A RECEPTACLE MARKED HOSPITAL GRADE OR HOSPITAL ONLY FOR GROUNDING RELIABILBITY. For safe operation of the Multi Flo Model # 1545 Series pump in the home environment, ensure that the pump is powered only from a grounded AC outlet. Authorized service personnel, in addition to possessing proper tools and testing equipment, have access to electrical schematics, calibration criteria and an inventory of identical replacement parts. In addition to possessing proper tools and testing equipment, authorized service personnel have access to electrical schematics, calibration criteria and an inventory of identical replacement parts. CLASSIFICATION 1. Class of protection against electrical shock.. CLASS II EQUIPMENT 2. The degree of protection against electric shock.. APPLIED PART TYPE B 3. Mode.. CONTINUOUS OPERATION WITH INTERMITTENT LOADING 4. According degree of protection against ingress of water.. IPXO 4

6 OPERATING INSTRUCTIONS: DESCRIPTION OF OPERATION Model #1545-KT (Calf & Optional Thigh Application) The cycle begins with a 14 to 16 second bilateral inflation/hold time at a pressure of 45 mmhg to 50 mmhg (preset at the factory), followed by a deflation / rest period of 44 to 46 seconds. This results in a rate of 60 cycles per hour. The pre-set pressure may be adjusted, upward or downward, as ordered by the attending physician Model #1545-F (Feet Application) The cycle begins with an inflation/hold of 5 to 7 seconds at a pressure of 90 mmhg to 120 mmhg, as ordered by the attending physician. This is followed by a deflation / rest period of 53 to 55 seconds. This results in a rate of 60 cycles per hour. GENERAL EQUIPMENT SPECIFICATIONS Multi-Flo Model #1545 Series Pneumatic Compression Device DIMENSIONS: H x W x D (in inches) WEIGHT: 8 lbs. MODEL #1545-K INFLATION / HOLD DEFLATION / REST CYCLE TIME: Sec s Sec s 60 Sec s / 60 cycles per hour MODEL #1545-F INFLATION / HOLD: 5-7 Sec s DEFLATION / REST Sec s UNPACKING EQUIPMENT INTERMITTENT CIRCULATOR By laying carton on its side, slide pump out with protective foam end caps still attached. After removing pump from carton, foam end caps may be detached by gently pulling off each side. NOTE: Be sure to SAVE carton and end caps for future transporting or shipping. When transporting, the carton is equipped with fold-up handles for easy carrying. SLEEVE/GARMENT Remove sleeves from package avoiding the use of sharp objects which could puncture or tear the garments bladder. 5

7 GENERAL INSTRUCTIONS 1. Plug the MultiFlo into a Hospital Grade outlet in close proximity to the area where treatment is to be received. 2. Remove the garment sleeves from their packaging and connect the tubing to the pump and garment as follows: Attach the tubing to the outlet valve on the garment by turning the fitting clockwise until securely fastened To remove the tubing from the garment, simply turn the fitting counter-clockwise and gently pull to disconnect. Attach the Quick-Connect end of the tubing to the pump face by pushing firmly inwards until it snaps in place. To remove the tubing from the pump, simply press the thumb tab on the connector and gently pull to disconnect NOTE: An inadvertent mismatch of garments with the pumps has been eliminated through the implementation of various Quick-Connect sizes and styles, making it impossible to connect any garment to a pump with which it does not belong. 3. Apply the garments to the patient, and use the Velcro-type fasteners to accomplish a snug but comfortable fit. 4. The pump is equipped with a low pressure/disconnect alarm. When the pump is first turned ON, a chirping sound is normally heard. This is the alarm setting itself. Should the alarm sound during treatment, check for crimped or disconnected tubing and stop treatment until the alarm problem can be ascertained and corrected before resuming treatment. NOTE: Turning the pump OFF, then ON again, will reset the alarm. Be sure that the tubing is connected properly and has a clear unobstructed path between pump and garment so as to prevent any snagging or crimping from bed rails or other objects which could cause an alarm or disconnect problem to occur. NOTE: Tubing and garments have been designed to withstand three times the normal operating pressure without any adverse performance characteristics occurring under normal temperatures. 6

8 ELECTROMAGNETIC COMPATIBILITY (EMC) The Model 1C-1545-KT/-F has been evaluated to International Standard EN :2001, Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility-Requirements and Tests: A. The MEDICAL ELECTRICAL EQUIPMENT needs special Precautions regarding EMC and needs to be installed and put Into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS; B. Portable and mobile RF communications equipment can affect the MEDICAL ELECTRICAL EQUIPMENT. 7

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11 CLEANING INSTRUCTIONS FOR THE FOOT GARMENT Disconnect the tubing from the outlet valve on the garment by turning counterclockwise. Disconnect garment tubing from pump/controller. To prevent ingress of excess fluids into the garment during cleaning, be sure that open ends of tubing are secured outside of basin/pan where the garments are being submerged. Mix 1 cup of 6% household bleach with 1 gallon of cold tap water. Entirely immerse garment, with Velcro not engaged, into this prepared solution and allow to soak for 30 minutes. Agitate garments by hand every 10 minutes Thoroughly rinse garments under cold running tap water, ensuring that the open ends of the tubing are not exposed Repeat wash cycle again as previously instructed. After rinsing garments, allow to air dry. CLEANING INSTRUCTIONS FOR CALF & CALF- THIGH GARMENT These garments are for single patient use only and should be maintained using a spray type of disinfectant. We recommend and have available for sale, ready to use in one quart bottles, ZEP Spirit II which is a Non- Phenolic, Germicidal Detergent/Disinfectant. In addition to deodorizing, Spirit II is a broad spectrum bactericidal, verucidal and tuberculocidal agent. 10

12 FUSE REPLACEMENT There are a total of two fuses associated with the Model # 1545 series, an inner fuse and an outer safety fuse. Of these two fuses, the outer safety fuse is the only item serviceable by someone other than a Bio Compression Systems technician who has been specifically trained in the manufacturing and repair of all Bio Compression Systems products at the factory. The outer fuse is located in the rear of the pump, adjacent to the power cord outlet. The outer safety fuse may be replaced by either the user of caregiver, provided it is replaced with an identical model and type ( BUSS MDL3 250V). Prior to the removal of fuse, disconnect the power cord from the wall socket or other power source. While pushing inward on fuse cap, turn counter clockwise to release cap and remove fuse. After placing new fuse inside of cap slot, push cap and fuse inward, while turning clockwise to lock in place. PACKAGING, SHIPPING & STORAGE The Multi-Flo #1545 series is shipped in a specially designed (275 test) corrugated re-usable carton with foam cushioned end-caps which envelope each end of the pump, thereby suspending the pump on all four sides within the carton. This packaging design prevents damage to the pump (which would ordinarily be sustained) when the carton is thrown or handled roughly by the carriers. NOTE: The carton and end-caps should be saved for re-use each time the pump is either transported or shipped. When transporting, for added convenience, the carton is equipped with a fold up handle assembly The device should be stored in a secure area, ideally F, however, short term storage or shipping with exposure to temperatures of 20 F to +110 F will not harm the unit. To maximize the unit s life, however, time should be allowed for temperature adjustment prior to use, when moving to areas of contrasting temperature. It is also advisable to avoid extreme heat (+110 F) or cold (-20 F) when long term storage is contemplated. 11

13 ACCESSORIES Multi Flo Model 1C-1545KT G K Knee High Bilateral DVT Appliances G T Knee High & Thigh Bilateral DVT Appliances Multi-Flo Model 1C-1545-F G F FOOT BILATERAL DVT APPLIANCES WARRANTY/ CUSTOMER SERVICE You can feel confident that your product is backed by the best and customer service in the industry covering any and all malfunctions, including parts and labor resulting from component and/or manufacturing defects. The Multi-Flo Model #1545 Pump is guaranteed for a period of 3 years from the date of purchase/ invoice. REPAIR SERVICE Prior to shipping product back for repair, Customer Service must be called at to obtain a Return Authorization Number. Repairs CAN NOT be performed or tracked without an assigned RA number. Be sure to have the product s serial number available when calling. The Serial Number can be found on the rear of the unit, printed on a rectangular foil type label. FOR MORE INFORMATIONS CONTACT: BIO COMPRESSION SYSTEMS, INC. 120 WEST COMMERCIAL AVE. MOONACHIE, NJ

14 BIO COMPRESSION SYSTEMS, INC. 120 West Commercial Ave. Moonachie, NJ Manual 1545-KT & F_ _Rev.D