Gima 33110 User Manual

Automatic tourniquet device

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P R O F E S S I O N A L M E D I C A L P R O D U C T S

AUTOMATIC TOURNIQUET

DEVICE

User manual

ATTENTION: The operators must carefully read and completely understand the

present manual before using the product.

Gima 33110

Avrasyamed Medı ̇ı ̇kal Tıbbı ̇ı ̇ Cı ̇ı ̇hazlar Ve Ürünler Pazarlama

Sanayi Ve Dış Tı ̇ı ̇caret Limited Şirketi

Cihangir Mh. Güvercin Cd. No: 4 İç Kapı No: 144 Avcılar

Istanbul Türkiye

www.avrasyamed.com.tr e-mail: info@avrasyamed.com.tr

www.medione.com.tr e-mail: info@medione.com.tr

Made in Turkey

TRQ-2024

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

106kPa

70˚C

-10C

50kPa

1984

90%

IP20

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Page 1 User manual ATTENTION: The operators must carefully read and completely understand the present manual before using the product. Gima 33110 Avrasyamed Medı ̇ı ̇kal Tıbbı ̇ı ̇ Cı ̇ı ̇hazlar Ve Ürünler Pazarlama Sanayi Ve Dış Tı ̇ı ̇caret Limited Şirketi Cihangir Mh.
Page 2 For clinical application, maintenance and problem solving of these devices, please read this manual carefully and understand the features and instructions before using the devices. AVRASYAMED MEDİKAL TIBBİ CİHAZLAR VE ÜRÜNLER PAZARLAMA SANAYİ VE DIŞ TİCARET LİMİTED ŞİRKETİ TELEFONO: +90-212 590 42 40/41 FAX: +90-212 590 00 15 E-mail: info@avrasyamed.com.tr E-mail:...
Page 3: Table Of Contents
Brand Statement is a registered trademark of AVRASYAMED MEDİKAL TIBBİ CİHAZLAR VE ÜRÜNLER PAZARLAMA SANAYİ VE DIŞ TİCARET LİMİTED ŞİRKETİ. Names and terms used for products of other manufacturers mentioned in this User Manual may be associated with registered trademarks or trademarks.
Page 4 11. Display and Buttons ..........................13 12. Power supply ............................14 13. Network mode ............................14 14. Battery maintenance and storage ......................14 15. Charging the Battery ..........................15 16. Initial use ..............................16 16.1. Unpacking and installing the appliance ..................16 16.2.
Page 5: General Information
1.General information 1.1. Symbols Used. SYMBOL/TERM Definition Follow instructions for use Insurance values F1, F2, F3:2A T; 250 V Manufacturer Date of Manufacture Product code Lot number Serial number Conformity Marking of the Council of the European Community including Notified Body ID no.
Page 6: About This Document
Caution: read instructions (warnings) carefully Type BF applied part Medical Device Distribué par 1.2. About this document The user manual is part of this product and contains information and instructions for the safe and proper use of the product. Read the user manual before using the product. Keep the instruction manual near the product or in an easily accessible place so that it can be accessed at all times.
Page 7: Possible Complications
• Swollen, infected, or inflamed areas at the site of use • Having malignant tumors • Having crushes • Severe arteriosclerosis • Severe crush wound • Severe hypertension • Thrombosis • Open fractures in the extremities • New dermal implants in the situ of use •...
Page 8: Use Of The Tourniquet Device In Potentially Explosive Environments
4.1.2. Use of the Tourniquet Device in Potentially Explosive Environments WARNING! Use of the tourniquet device and all accessories in environments where explosive or flammable anesthetic agents or cleaning materials are present may cause serious injury and damage to the tourniquet device.
Page 9: Cleaning And Disinfection
The automatic tourniquet device must be connected to the grounding socket with a 3 m grounding cable, especially to avoid electric shock. No multiplexer socket or extension cord should be used. To protect the patient from electrical hazard, do not use the medical device immediately next to the patient (distance not less than 2 meters).
Page 10: Description Of Tourniquet Device
responsible surgical staff, take immediate action to resolve the issue. However, the battery of the device should be replaced with a new one every 2 years to ensure that maximum safety is constantly ensured and that the tourniquet device is in good condition. Make sure your tourniquet device and accessories are in working order before starting the application.
Page 11: Front Panel
Each time the tourniquet device is operated, it performs an automatic test. This initial system check ensures the safe operation and function of all important components. So you are always working with a safe tourniquet device. The device cuff connections must be left open before the self-test begins. Connection hoses and cuffs must not be plugged in! If the test is successful, the device is ready for use.
Page 12 TRQ-2024 TRQ-2022 Image No. Functions. Error Code Visual Alarm Display LCD LED Alarm Indicator AC/DC Charging Indicator Display LCD AC Led Indicator Light ON/OFF Button Proximal Pressure Gauge and Adjustment Screen Proximal Time Display and Setting Display Inflate/Deflate Button Proximal Distal Pressure Gauge and Adjustment Screen Distal Time Display and Setting Screen Inflate/Deflate Button Distal...
Page 13: Color-Coded Connections For Ivra Implementation
When both channels are used: In this case, two attachment points (channels) for the arms and legs can also be used. 9.1. Color-coded connections for IVRA implementation Tourniquet connections are color-coded to make IVRA application easier with the tourniquet device. When using a dual-chamber cuff for an IVRA application, connect the distal and Proximal cuff chambers as described below: The left attachment point is colored red and indicates the Proximal cuff chamber.
Page 14: Display And Buttons
6.Ventilation outlet 11. Display and Buttons Buttons/Icons/Connector Functions Device On/Off Key (2 sec.) Choosing Regional Intravenous Anesthesia (IVRA) Setting Screen Login Button Mmhg Pressure Unit Time Counter Alarm Silence Button Charge Indicator AC Indicator LCD Display Error Code, Information Display Proximal part DEFLATE (Stop tourniquet) Proximal Part INFLATE (Initiating the Tourniquet) Distal Part: DEFLATE (Stop the tourniquet)
Page 15: Power Supply
Volume Alarm Timer Date Time Setting Screen Brightness Adjustment Language Setting Alarm Log Backspace 12. Power supply internally The tourniquet device can be powered by voltage and can be operated using a power supply or an powered battery. The manufacturer recommends always using a power supply to operate the Medione Automatic tourniquet device.
Page 16: Charging The Battery
If the tourniquet device is being transported, the battery must be fully charged and the battery protection must be removed. Observe the information on the label on the back of the tourniquet device. The battery of the tourniquet device can only be charged with the battery protection installed, the switch on the back of the device is in the 1 position, the device is in standby and use.
Page 17: Initial Use
4. Be sure to charge the battery after using the device (regardless of the current battery condition). 5.Make sure the battery is fully charged before use. Display Indicator Charging Status Explanation The gauge stage is fully charged Battery fully charged 100% Indicator stage flashing Ac power on, battery charging, battery below 90%...
Page 18: Checking The State Of Charge Of The Battery
16.3. Checking the state of charge of the battery Check the steps in Chapter 15 for the battery charge status. For safe use, the battery charge and your battery must be intact. 16.4. Switching on the appliance Connect the power cord of the device, turn the power switch on the back of the device to position 1. Turn on the tourniquet device by pressing the On/Off button on the device for 2 seconds.
Page 19: Operating The Appliance
Attaching to movable stand (optional) You can connect the tourniquet to the movable stand using the optional accessory (AVR-ST001). The movable stand has a basket where you can store the connecting hoses, cuffs and accessories. 1.Tourniquet device connection apparatus 2. Handle 3.
Page 20: Changing The Pressure (Preoperatively)
Separation of the proximal and distal parts from each other by colors The device is divided into two parts, PROXIMAL and DISTAL, in each section, TRQ-2024 has 4 outputs and TRQ- 2022 has 2 outputs. These circuits are completely separated. Pressure settings and timers are independent, the adjustment procedure is the same.
Page 21: Changing The Pressure (During Surgery)
17.2.3. Changing the pressure (during surgery) During the surgery, the measured pressure is shown on the PRESSURE screen, and when the pressure is desired to be changed, the pressure can be increased or decreased by clicking on the relevant part and using the buttons.
Page 22 For more information on the placement of the cuffs, refer to the tourniquet cuff instruction manual. Example: Protective bandage Example: Tourniquet cuff and protective bandage application The Tourniquet Cuff should not be used without a protective bandage. Before application, it is recommended to wrap the tourniquet area with a protective bandage.
Page 23 The pressure to be adjusted in PROXIMAL or DISTAL extirimity is adjusted from the time and pressure screen over the appropriate channel. Device connections and patient connections are reviewed. After the information is entered on the setting screen, the information is saved with the OK button. Pressure and Time Setting Display Tourniquet Device Home Screen INFLATE button in the relevant section on the main...
Page 24: Termination Of The Tourniquet
18. Termination of the Tourniquet Before the time of the entered tourniquet expires, the device gives a warning alarm, writes PROXIMAL DEFLATE or DISTAL DEFLATE for the finished part , and after the alarm sound, decide together with the responsible physician whether the tourniquet should be continued or terminated.
Page 25: Settings
Make pressure and time adjustments following the procedure set out in Section 17.2.2. Fill the proximal sac with air pressure. Anesthetic injection and after its effect • Inflate the distal sac so that the tourniquet cuff presses on the area above the anesthesia •...
Page 26 The volume adjustment key is pressed by entering the settings menu via the settings button on the LCD screen. In the volume adjustment menu, the volume level is specified as 4 levels. The device volume can be adjusted using the up and down buttons. The volume will be audibly audibly heard when the up and down keys are pressed. You just need to return to the main menu with the back key so that the settings are automatically saved.
Page 27: Troubleshooting
Screen Brightness Adjustment Language Setting. The device language can be changed to TURKISH and ENGLISH with the option to change the language through the device settings menu. When the current key is pressed, the language can be selected as TR (Turkish) and EN (English). The settings will be saved automatically.
Page 28 Drain valve defective Make sure that the tourniquet cuff on the proximal part is not attached. Proximal Turn off the tourniquet device and turn it on again If the device repeatedly displays the same safety message, contact your dealer. Distal drain valve Make sure that the tourniquet cuff on the distal part is not attached.
Page 29: Technical Information/Parameter
Drain valve defective 1. Make sure the cuff and hose are plugged into the correct port. or clogged Proximal 2. Make sure the cuffs and hoses are seated correctly at the connection points. 3. Make sure that the cuff is not too loosely attached to the patient's limb. Change the cuff size if necessary.
Page 30: Accessories List
Insurance Mains power: F1,F2: 2 A 250 V Mains power: F1,F2: 2 A 250 V Battery: F3: 2 A Battery: F3: 2 A Breaking capacity 2 A Breaking capacity 2 A Type: Fused connection 5 m Type: Fused connection 5 mm x 20 mm x 20 mm 14.4V, 5.8Ah...
Page 31: Electromagnetic Compatibility (Emc) Statement
AVR-CUFF S034 34" Reusable Long size Leg 34"L x 5"W Single chamber Single hose AVR-CUFF S038 38" Reusable Long size Leg 38"L x 5"W Single chamber Single hose AVR-CUFF S042 42" Reusable Extra long Leg 42"L x 6"W Single chamber Single hose AVR-CUFF S044 44"...
Page 32 Voltage Fluctuations / Flicker public low-voltage power supply network that supplies Complies buildings used for domestic purposes. emissions IEC 61000-3-3 Guide and Manufacturer's Declaration - Electromagnetic Immunity This device is designed for use in the electromagnetic environment specified below. The customer or user of this device should ensure that it is used in such an environment.
Page 33 Guide and Manufacturer's Declaration - Electromagnetic Immunity This device is designed for use in the electromagnetic environment specified below. The customer or user of this device should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications...
Page 34 Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and This Device This device is intended for use in an electromagnetic environment where RF interference can be controlled. To protect against electromagnetic interference, the owner or user of this device should maintain a minimum distance from portable and mobile RF communication equipment (transmitters) as specified below, according to the maximum output power of the communication equipment.
Page 35 Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies KK0102/Rev.02/03.02.2025...

This manual is also suitable for:

Trq-2024 Trq-2022