The Hpm™ Tourniquet 800-20 and 800-40 are microprocessor-controlled medical devices designed to monitor and act as a single cuff or as a double cuff in IVRA mode. These tourniquets are dependent on external air pressure and work independently with a built-in pump and battery. The system is controlled via a touch screen, and power cord, hose/hoses, and user instructions are included.
Function Description:
The Hpm™ Tourniquet is an electronic tourniquet instrument intended for controlled venous and arterial blood circulation to an extremity for a period of time, as for operations in a bloodless field. The pressure is applied circumferentially upon the skin and underlying tissues of an extremity; this pressure is transferred to the walls of vessels, causing them to become temporarily occluded. It is generally used as a tool for medical professionals in applications such as cannulation or to stem the flow of traumatic bleeding. The device is intended for routine clinical use and should only be used by medical professionals trained in the operation of the device. Incorrect use may cause severe harm or death. The operators are required to supervise the instrument during use.
Important Technical Specifications:
- Electrical Power Input: 100-240 VAC, 50-60 Hz
- AC Receptacle: IEC type per CEE22V (hospital grade)
- Temperature Range (operating): +5 to +40 °C
- Temperature Range (transport & storing): -10 to +50 °C
- Relative Humidity Range: 20-80% non-condensing (operating, transport, storing)
- Atmospheric Pressure Range: 75 to 106 kPa
- Pressure, Maximal Level: 600 mmHg (emergency stop during malfunction)
- Pressure, Operating Range: 50 mmHg to 550 mmHg
- Weight: 2.5 kg
- Dimensions: 200 mm (wide) x 195 mm (high) x 145 mm (deep)
- Pressure Output Port: CPC connector
- Accuracy: ±5 mmHg or 2% full scale
- Inflate Time: ~5 seconds
- Class & Type: Class 1, type B
- Printer Interface: USB
- Backup Battery: NiMh, 7.2 V 4500 mAh
- Alarm Sound Level: 73dB
Usage Features:
The tourniquet features a touch screen interface with various icons for control and monitoring:
- Volume Icon: Displays 1-5 levels of volume.
- Settings Icon: Used to open the menu.
- IVRA Icon: Activates IVRA mode.
- Timer Icon: Default setting is counting up.
- Inflate Icon: Activates the pump.
- Pset Pressure: Displays the preset pressure.
- Current Cuff Pressure: Shows the current cuff pressure in mmHg.
- Deflate Icon: Deflates the cuff.
- Battery Icon: Indicates battery status.
- AC Power Connection Icon: Shows when AC power is connected.
- Applied Part: Indicates the cuff connection.
- Double Timers: For dual cuff operations.
The device supports both single and double cuffs. For double cuffs, the unit will alert the operator if AC power is disconnected and will show a low battery status. For IVRA, the unit will alert the operator if AC power is disconnected and will show a low battery status.
Operator Profile:
Users of the equipment must have medical training, experience, and skill, and should have proper training on the equipment for safe usage and treatment (e.g., surgery staff, anesthesia staff). Trained staff should have knowledge about rules and guidelines for operating in bloodless fields and technical/practical knowledge about applying cuffs and setting correct limb occlusion pressure (LOP).
Before Taking in Use:
The tourniquet should be placed on a stable surface. Before taking it into use, ensure the battery is fully depleted and then connect it to AC power to charge. A fully charged battery is indicated by a green light on the power switch. The device should be protected from liquids or blood. Ensure the Hpm™ coiled hose is kept out-of-reach of the patient. Ensure that the equipment is placed without risk to fall down. The coiled air hose has CPC-quick connectors. The air outlet, coiled hoses, and cuffs are color-coded. The device performs a self-test upon startup, which includes checking the pump, valves, and sensors. If errors are detected, an error message and an alarm icon will appear, and an audio alarm will sound.
Cuff Inflation and Pressure Adjustment:
To inflate the cuff, press the "Inflate" icon. The pump will activate within seconds, and if no leaks are detected, the pump will inflate the cuff until the desired pressure is achieved. A white frame and a green arrow indicate the monitored side. The "Inflate" icon is replaced by "-5" and "+5" icons for pressure adjustment during the procedure.
Alarm System:
The device is designed to test and supervise itself during startup to alert the operator of any faults or errors. If errors are detected, a message is displayed, and an audio alarm is emitted. Alarms are categorized by priority:
- High Priority (Red): 10 beeps repeated every 10 seconds.
- Medium Priority (Yellow): 3 beeps repeated every 20 seconds.
- Low Priority (Yellow): 1 beep.
All alarms have the same sound level. An automatic safety mechanism closes all valves and turns off the pump for high or medium priority alarms. To exit this state, the operator can perform a self-test, acknowledge the alarm, or correct the cause of the alarm.
Common Alarm Messages:
- Safe State: Block valve, deflate valve, and pump are de-energized to prevent pressure changes. Monitoring continues.
- Instrument Error: Restart or contact service.
- Critical Battery: Insufficient battery for high priority alarm burst and safe state switch.
- Low Battery: Battery can maintain monitoring and valve control but no pump control for less than 10 minutes.
- Invalid Pressure: Measured pressure is invalid.
- High Pressure: Pressure > 30 mmHg above Pset.
- Low Pressure: Pressure < 15 mmHg below Pset.
- Critical Low Pressure: Pressure < Pset - 75 mmHg.
- Critical High Pressure: Pressure > 100 mmHg above Pset.
- Inflating Leakage: Set pressure not reached within 20 seconds.
- Inflated Leakage: Pump cannot keep set pressure in cuff.
- Timeout: Timer counting down (Medium priority).
- Time > 60/90/90 n*15 min: Timer alerts (Low priority).
- Time Limit: Timer after 180 minutes (Medium priority, risk of harming patient).
- Fatal CPU/Pressure Failure: Instrument testing continuously (High priority).
- Mains Failure: In Idle (cuff has no pressure) (Low priority).
- Kink (inflate): Kink while inflating (Low priority).
- Battery Fault: Battery cannot be charged properly (High priority).
- Sensor Consistency: Pressure sensor fail detected (High priority).
- Cuff Not Connected: A cuff is un-connected (Low priority).
Maintenance Features:
- Cleaning: The tourniquet is not intended to be sterilized. Clean the device with a damp, soft cloth using mild detergents or Ethanol 30%.
- Hose Kit: Visually inspect the spiral hose before every new procedure for cracks or discoloration. Replace spiral hoses after fifty-four (54) months. Spiral hoses are considered consumables. No modification or shortening of spiral hosing is allowed; if damaged, it needs to be replaced with a new original spiral hosing.
- Calibration: Perform a pressure test for internal leakage and a pressure calibration of the system every twelve (12) months or after changing any vital parts. Contact your local distributor for information about leakage tests.
- Battery Check: The battery needs to be checked once a year. A discharged battery should charge within 3 hours. If not, the battery needs to be replaced (considered a consumable). It is recommended to replace the battery every twenty-four (24) months.
- Data Log: The device logs data for each operation, including date and time of start, set pressure, actual operation duration, mains/IVRA/cuff status, and error descriptions. The log can be printed out only after a procedure and is maintained during AC power failure and after the tourniquet is powered down.
Accessories:
- Printer: Art. no 800-10 Model EPSON TM-T88V (supplied with screened cable).
- Clamp: Art. no 800-25.
- Mobile Stand: Art. no 400-45.
- Basket: Art. no 400-85.
- Cuffs: Hpm™ Reusable and autoclavable single and double cuffs, and Hpm™ Disposable single and double cuffs. Disposable cuffs are sterilized and for use according to hospital procedures and regulations. Only CE-marked Hpm™ cuffs should be used with Hpm™ Tourniquet 800-20 and 800-40.
EMC Guidance:
The tourniquet should not be used adjacent to or stacked with other equipment. The use of any other printer than listed in chapter 9 may result in increased emissions or decreased immunity of the tourniquet. The device is intended for use in a typical commercial or hospital environment. Mains power quality should be stable. If continuous operation is required during power mains interruptions, the tourniquet should be powered from an uninterruptible power supply or battery.
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