IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 TABLE OF CONTENTS 1 INTRODUCTION 1.1 I NTENDED CLINICAL USE 1.2 U ANUAL 1.3 M ANUFACTURER 1.4 W ARRANTY 1.5 C OPYRIGHTS 1.6 C USTOMER SERVICE 1.7 CE LABELING 1.8 T OURNIQUET FRONT VIEW 1.9 T OURNIQUET REAR VIEW 1.10 L...
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IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 4 ALARM 4.1 A LARM SYSTEM 4.2 T HE AUTOMATIC ALARM SAFETY MECHANISM 4.3 A LARM PRIORITY 4.4 A LARM RESET 4.5 C OMMON ALARM MESSAGES 5 BATTERY FUNCTION 6 CARE AND MAINTENANCE 7 DATA LOG 8 TECHNICAL SPECIFICATIONS 9 ACCESSORIES...
In case of difficulty, details of the local dealers are available at www.hpm.se. You may also contact the service center in Sweden (email: service@hpm.se).
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 4. This product is not considered to be defective in materials nor workmanship by reason that it requires adaptation in order to conform to national or local technical or safety standards in force in any country other than the one for which the product was originally designed and manufactured.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Tourniquet front view 1. Volume icon. 1-5 levels shows level of volume. 2. Settings icon. Press symbol in order to open menu. 3. IVRA icon. Press symbol in order to activate. 4. Timer icon. Default setting is counting up.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 1.10 Label 1. Operating voltage in Volts (100- 240V ~50/60Hz) 2. Class 1 3. Manufactured by 4. Contains electrical components, plastic parts and battery. Return the instrument to the manufacturer or dispose it in accordance with legal regulations and local ordinances.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Handling packaging materials: Dispose of packaging materials in accordance with legal regulations and local ordinances. Dispose of packaging in an environmentally safe manner. Follow the local disposal ordinances. If necessary, hire a professional disposal service. Storing packages: Do not store outdoors.
(normally up to 3 hours for a depleted battery). Protect the instrument from liquids or blood. Use an original Hpm™ coiled hose to keep the instrument out-of-reach of the patient.
Procedure options The Hpm™ Tourniquet has two intended options of use, single cuff procedure and double cuff IVRA procedure. When a single cuff is used, the user can inflate or deflate the applied cuff for either upper or lower limb.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Icones used Pset indicates chosen pressure Inflate indicates inlet of pressure mmHg indicates pressure in cuff Deflate indicates outlet of pressure IVRA Grey indicates inactive IVRA IVRA Green indicates active IVRA min 000 indicates elapsed time 000 indicates the time on each side Battery symbols: Battery fully charged...
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Front panel with inflated cuff A white framework shows if cuff is inflated and green arrow indicates monitored side. The Inflate icon is replaced by a “-5” respective “+5” icon. In order to adjust the pressure during procedure, press “+5” icon to increase and press “-5” icon to decrease pressure.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 3 Options Settings By pressing (sub menu icon) you enter the sub menu. If no icon is pressed within 30 seconds, the main menu returns automatically. 3.1.1 Information By pressing (information icon) data regarding the unit will occur (manufacturer, model, serial number and software version).
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 3.1.6 Settings By pressing (settings icon) you will enter default settings menu. Default timer. Press to set default timer. Default Pset. Press to set default pressure (mmHg) in steps of 5 mmHg or use the slider and confirm with “OK”.
The default value can be adjusted in the settings (3.1.6) Accurancy of the pressure The Hpm™ Tourniquet is designed in order to maintain the inflated cuff pressure during the time of the procedure. When the cuff is inflated, you may change the Pset pressure in steps of + or – 5 mmHg keys, or press the “Pset”...
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Icon for sub menu Green arrow indicates time count up from zero (0) IVRA overview IVRA (Intravenous regional anaesthesia), also known as a Bier´s Block, is used to enable the infused aesthetic to first take effect on the distal part of an extremity. After a period of time, cuff pressure is applied on the already anesthetized part of the extremity and the cuff is deflated on the more proximal portion of the limb.
3. If IVRA is not desired, press ”Cancel” and the main menu returns without IVRA function and the “IVRA” icon remains grey. Cancel IVRA Confirm IVRA Change default pressures Hpm™ Tourniquet permits the user to change the factory default pressure of 200 mmHg (ref. 3.1.6). To restore default factory settings, see section 3.1.6.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 4 Alarm The device is designed to test and supervise itself during the start up process to alert the operator of any faults or errors which might cause problems during the use of this product. The start-up tests are performed every time the unit is activated to review the status of both the software and hardware of this microprocessor controlled device.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Common alarm messages Signal definition Safe State The state when the block valve, the deflate valve and the pump all are de-energized creating independent means to prevent the increase or Icon: decrease of a cuff pressure. Monitoring of pressure values continues. Make self test to clear this state.
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IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Alarm message Description Priority Comment Timeout! Timer counting down Medium Time > 60 Timer 60 minutes Timer additional 30 Time > 90 minutes Time > 90 n* 15 Timer reminder every 15 minutes Time limit Timer after 180 minutes Medium...
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 5 Battery function Charge capacity varies highly between individual units and over time. Note: 1) The battery is to be used only as a temporary backup in case of failing AC power. 2) Battery capacity can suddenly decrease quickly in a non-linear fashion. 3) The following is an indication only and must not be used as absolute measurement of remaining capacity: : Battery fully charged.
IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Calibration Perform a pressure test for internal leakage and a pressure calibration of the system each twelve (12) months or after changing any vital parts in the unit such as internal hoses, pumps or valves. Contact your local distributor for more information about leakage test.
Hpm™ Reusable and autoclavable single and double cuffs, Hpm™ Disposable single and double cuffs. Hpm™ disposable cuffs are sterilized and are only to be used according to hospital procedures and regulations. The following codes are referred to as Hpm™ Disposable cuffs;...
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IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Guidance and manufacturer's declaration - electromagnetic emissions The tourniquet is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment Test Compliance Electromagnetic environment - guidance RF emissions Group 1...
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IFU EN T800, Rev 09/2016-07-07, art.no. 8004007...
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IFU EN T800, Rev 09/2016-07-07, art.no. 8004007 Article number Article 800-20 Hpm™ Tourniquet 800-20, single 800-40 Hpm™ Tourniquet 800-40, double 800-10 Printer for Hpm™ Tourniquet 800-series 800-11 Label roll for printer 400-45 Stand for systems of Tourniquets 800-25 Clamp Hpm™ Tourniquet 800-series 400-85 Basket incl.
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