Stryker Restep User Manual

Stryker Restep User Manual

Deep vein thrombosis (dvt) system

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Deep Vein Thrombosis
(DVT) System
User Manual

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Table of Contents
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Summary of Contents for Stryker Restep

  • Page 1 Deep Vein Thrombosis (DVT) System User Manual...
  • Page 2 “ Restep —an economical and INNOVATIVE solution for today’s HEALTHY Hospital.
  • Page 3: Table Of Contents

    TABLE OF CONTENTS INTRODUCTION ......................... 2 Clinical Indication for use ......................2 Contraindications ........................2 Precautions ........................... 3 GENERAL........................... 3 Symbols ..........................3 Notes, Cautions, and Warning statements ................4 EMC Warning......................... 4 Hazard Information ........................ 4 SYSTEM COMPONENTS ......................5 Pump Kit/Accessories ......................
  • Page 4: Introduction

    INTRODUCTION This manual should be used for the initial set up of the Restep system and for reference purposes. ® Clinical Indications for use The primary application of the Restep system is for the prevention of Deep Vein Thrombosis (DVT) ®...
  • Page 5: General

    „ It is not recommended that pumps or Bed Brackets (RSP166) if applicable are permanently fastened or tied to objects. „ Only the pump and garment combinations provided by Stryker Sustainability Solutions should be used. The correct function of the product cannot be guaranteed if the incorrect pump/ garment combinations are used.
  • Page 6: Notes, Cautions, And Warning Statements

    2. DO NOT attempt to repair broken AC Adapter Power Supply casings or cords; 3. DO NOT attempt to open or repair pumps. Although the Restep DVT Pump System is designed to be a low voltage device, hazard information review, and good operational practice as described in this section should be applied.
  • Page 7: System Components

    SYSTEM COMPONENTS A complete system should contain the following components. If any of the following items are missing or damaged, please contact your Stryker Sustainability Solutions representative for immediate assistance. Item Number: PUMPKIT includes the following items: RSP164 RSP159 Pump Battery 12’...
  • Page 8: Garments

    Garments All Restep DVT garments have a single center inflating bladder and adjustable straps with hook ® tab attachments. The garment tube inlet to the garment should be rotated to the most comfortable position for the tube set, depending on where the pump is placed.
  • Page 9: System Installation

    SYSTEM INSTALLATION Battery installation Unscrew the battery cover then Push the connectors firmly onto Fit the battery into the compartment. connect the battery male connector the female connector to secure Make sure that nothing gets in the to the female connector inside the the battery wires within the way of the battery cover.
  • Page 10: Using The Bed Bracket

    • Use only the provided manufacturer approved power adapter included in the package. DO NOT USE any other power adapters with the Restep system. Replacement Item Number: RSP164. ® Using the bed bracket (RSP163) The pump may be attached to a bed frame with the supplied embedded bed bracket.
  • Page 11: Garment Use

    GARMENT USE Secure the pump at the foot of the bed or in place of use. The pump connectors are located at the top left of the pump. Attach the 6 ft. or 10.5 ft. tube set to the pump by pushing in the silver latch on the female pump connector and then inserting the male tube connector into the pump connector until a click is heard.
  • Page 12: Bariatric Calf Garments

    Bariatric Calf Garments The bariatric calf garments are specially shaped to conform better to the bariatric patient’s lower legs. The bariatric calf garments may be used on either leg. Unfold the garment(s) and position the inflatable center bladder directly behind the patient’s calf. The outlet tube on the garment should not be in direct contact with the patient’s skin.
  • Page 13: Foot Garments

    NOTE: • Foot garments should be removed prior to patient ambulation or transportation. • See online IFU for full details: http://restep.stryker.com SYSTEM CONTROLS Front control panel The functions of the Restep system pump are described below.
  • Page 14 1. Power Switch Press the Power Switch to turn the power ON/OFF, and to start/stop the pump. 2. Alarm Graphic This is NOT a key. This graphic highlights the function of the HIGH/LOW pressure alarm indicators. 3. Garment Type Selection Key TYPE selection key is inactivated after 60 seconds of initially powering on the pump.
  • Page 15: Pump Operation

    LEG GARMENT light will be lit constantly. NOTE: When the POWER button is pressed, Restep pumps using Software PSoC Version 2.3 will also produce an audible beep and the BATTERY CHARGE and LOW BATTERY lights will flash simultaneously. A label indicating Software PSoC Version 2.3 can be found on the back of the pump if applicable.
  • Page 16: Garment Mode Selection

    „ Ensure the garment is wrapped snugly around the extremity as required. If not, refit the garment. „ If the alarm continues, there may be an internal pump fault indicating the pump may need servicing. Remove pump from service and contact your Stryker Sustainability Solutions representative. DO NOT CONTINUE TO USE. LOW PRESSURE This alarm may sound when a garment is new and is first applied to the patient.
  • Page 17: Critical Low Battery

    Power Supply after 48 hours. The alarm is an indicator that the battery pack may have a fault or has reached its limit to properly maintain useful charge. Remove pump from service and contact your Stryker Sustainability Solutions representative. DO NOT CONTINUE TO USE.
  • Page 18: Troubleshooting

    • If the pump does not work correctly after these initial troubleshooting steps, remove pump from service and contact your Stryker Sustainability Solutions representative for immediate assistance. It is not recommended for the user to open the enclosure and try to repair anything inside the pump.
  • Page 19: Cleaning

    CAUTION: DO NOT allow excess cleaning solution on control panel of pump or inside accessories, damage may occur. Garments „ Garments are single patient use and should be collected for reprocessing after each patient use. „ Stryker Sustainability Solutions provides a full reprocessing service for used garments.
  • Page 20: Preventive Maintenance

    NOTE 2: DO NOT disassemble the pump housing as this will void the warranty. If the pump is not operating prop- erly, contact your Stryker Sustainability Solutions representative. NOTE 3: Restep Pump inspection and testing may take approximately 15 minutes to execute. Materials Needed: 1 x Calibrated Manometer (Minimum Accuracy: of at least ±...
  • Page 21 Locate a 6’ Tube Set (RSP154). Cut tube 6” from male end. Remove male connector from the other 6’ Tube in set. Gather male connector and 6” tubing. Insert male connector into 6” tubing. Attach male-to-male connector to outlet ports of pump. „...
  • Page 22 Cut tube 3” from male connector end. Cut 3” piece of tubing. Cut tube 3” from female connector end. Gather all components as illustrated. Modified tube set is made by Attach garment, 6’ tube, modified tube connecting the three pieces together set, manometer, and pump.
  • Page 23 „ During inflation verify a manometer reading of at least 75mmHg. It may take up to three (3) cycles to achieve this pressure while the garment inflates and fits its shape to the solid object. Inflation will happen in multiple segments. Verify the manometer reading falls below 20mmHg during deflation.
  • Page 24: Handling And Storage

    • Please contact your Stryker Sustainability Solutions representative for appropriate disposal method. RETURNS Any equipment, failing to work properly, should be returned to Stryker Sustainability Solutions. Prior to return, please contact Stryker Sustainability Solutions at 888.763.8803 for the best method of return.
  • Page 25: Specifications

    SPECIFICATIONS Item Specifications Pump Kit: PUMPKIT Pump: RSP101 Leg Garments: RCG10 Item Number Thigh Garments: RTG30 Bariatric Calf Garments: RBG60 Foot Garments: RFG210 Classification Class II ; IPX0; NO AP/APG; Type BF Mode of Operation Continuous, Internally powered, portable. Applied Part Garment Item #: RSP159 Type: TWM15-09-UN-585L-ASC / TRUMPower...
  • Page 26: Emc Guidance And Declarations

    EMC GUIDANCE AND DECLARATIONS The following EMC Guidance and Declarations refer to the Restep DVT system. ® Guidance and manufacturer’s declaration – electromagnetic emissions This device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
  • Page 27 Guidance and manufacturer’s declaration – electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment –...
  • Page 28 Guidance and manufacturer’s declaration – electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment –...
  • Page 29 Recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.
  • Page 30 NOTES:...
  • Page 31 The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets.
  • Page 32 MANUFACTURED FOR 1810 West Drake Drive Tempe, Arizona, 85283 888.888.3433 restep.stryker.com RM801005J Printed in the USA...

This manual is also suitable for:

Rsp101

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