Monidor Monidrop W Operating Manual

Infusion monitor
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Monidrop W
Infusion monitor
Operating
manual
Software version 1.X.X
0598
®
EN
MONIDOR

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Summary of Contents for Monidor Monidrop W

  • Page 1 MONIDOR ® Monidrop W Infusion monitor Operating manual Software version 1.X.X 0598...
  • Page 2 CONTENTS...
  • Page 3: Table Of Contents

    CONTENTS 1 Monidrop® W infusion monitor / General 1.1 General 1.2 Attaching Monidrop to a drip chamber 1.3.1 Purpose of use 1.3.2 Use 1.3.3 Blood transfusion 1.3.4 Other infusion factors 1.3.5 Safety standards 2 Symbols / Menu structure 3 Using the device 3.1 Activation and start of infusion 3.1.1 Preparations 3.1.2 Starting the device...
  • Page 4: MonidropĀ® W Infusion Monitor / General

    1 GENERAL 1 Monidrop® W infusion monitor / General 1.1 General Drip detector Green light: Infusion in progress Yellow light: Notification Brackets for various drip chambers. Screen Notification button Drip size Latch, indication press to open Power button Charging port is locat- ed at the bottom of the device.
  • Page 5: Attaching Monidrop To A Drip Chamber

    1 GENERAL 1.2 Attaching Monidrop to a drip chamber 1. Open the locking mechanism by press- ing the locking lever and open the latch. With collar Without collar 2. Put the drip cham- ber into place as shown in the figures. Note the correct po- sitioning of different types of drip cham-...
  • Page 6 1 GENERAL Correct positions of drip chambers: Figure 2. Drip chamber without Figure 1. Drip chamber with a a collar collar Back Front Back Front Place the drip chamber in the Monidrop® W device so that the air intake cap points forwards or backwards. If the drip chamber has a collar, guide the edge of the collar to the lower slot (Figure 1).
  • Page 7: Purpose Of Use

    1.3.2 Use • Users of the Monidrop® W infusion monitor must read this op- erating manual before using the device. A Monidor salesperson or another authorised person must provide the first guidance of use. •...
  • Page 8 1.3 PATIENT SAFETY erful spotlight or a flashing fluorescent tube. In this case, the measurement accuracy cannot be guaranteed. • The device must not be used during magnetic resonance imaging (MRI). • The Monidrop® W infusion monitor is designed as a measuring device for the administration of maintenance fluids, nutrition- al solutions, blood products or antibiotics.
  • Page 9: Blood Transfusion

    If the device drops or suffers a heavy impact, it must be sent to a service point for inspection. • Only use the charger delivered with the Monidrop W device. • Do not tilt the device heavily when using it. If the device is tilted by more than 20 degrees, its measurement accuracy cannot be guaranteed.
  • Page 10: Other Infusion Factors

    1.3 PATIENT SAFETY 1.3.4 Other infusion factors • Check the compatibility of the products and medicine used from the manufacturers’ specifications. 1.3.5 Safety standards • The Monidrop® W infusion monitor fulfils all safety regulations of standards IEC/EN 60601-1 and EN 60601-1-11:2015 on medi- cal electrical equipment.
  • Page 11: Symbols / Menu Structure

    2 SYMBOLS / MENU STRUCTURE 2 Symbols / Menu structure Device symbols: Power switch On/Off Notification button Näytön symbolit: Device or drip chamber tilted Battery status Infusion rate more than 1,200 Mute ml/h Sound on Infusion rate less than 6 ml/h Drip indicator Unstable drip detection Remotely set target limit...
  • Page 12 2 SYMBOLS / MENU STRUCTURE Label: Symbol Description of symbols Note: Read the instructions delivered with the product. Drip size: 20 drops (gtt)/ml Markings of electrical and electronic equipment in accordance with direc- tive 2002/96/EC (waste electrical and electronic equipment) CE marking in accordance with direc- 0598 tive 93/42/EEC...
  • Page 13 2 SYMBOLS / MENU STRUCTURE Main screen (measurement view) The top row indicates the device status; battery status, infusion rate and notification sound. Treatment duration Current infusion rate Liquid volume administered during treatment If the line in the adjacent figure is shown for the current infusion rate, the measurement result is uncertain or the drip cannot be detected.
  • Page 14: Using The Device

    3 USING THE DEVICE 3 Using the device 3.1 Activation and start of infusion 3.1.1 Preparations Insert the pointed tip of the IV line into the bottle in an upright position. Fill at most 1/2 of the drip chamber to keep the drip detection function operational.
  • Page 15: Starting A New Treatment

    3 USING THE DEVICE Note: Attaching different types of infusion sets to the Monidrop® W device must be done in accordance with the instructions. WARNING: Do not apply any force when attaching the drip chamber to the Monidrop® W device. If the fastening mechanism seems stiff, check that the position and installation of the infusion set and clamp is correct.
  • Page 16: Notifications

    4 NOTIFICATIONS 4 Notifications The Monidrop® W infusion monitor is equipped with its own notifica- tion system (notification sound and optic notification). Notificati- Notifi- Optic notification Acknowledg- on type cation ment Yellow Text/image tone Visual no- Conti- Blinking Automatic tification nuous triangle once the...
  • Page 17: Battery Low

    4 NOTIFICATIONS 4.1.2 Battery low The device gives notification with a blinking yellow light, a notification tone and a flashing triangle at the infusion rate symbol. The message is automatically cleared when the device is connected to the charger. • The device gives notification when the battery status is down to 10%.
  • Page 18: Battery Charge And Maintenance

    5 BATTERY CHARGE AND MAINTENANCE 5 Battery charge and maintenance The Monidrop® W infusion monitor is equipped with a rechargea- ble lithium ion polymer battery. A new battery can be used for 72 hours on one charge. To ensure optimal use, the device is equipped with a protective function against overcharging and excess battery discharge (prevention of deep discharge).
  • Page 19 (2) years. This is the typical service life of the battery (without causing any significant reduction in the operating period). After two years, the battery will be replaced during scheduled maintenance. The battery can only be replaced by a service provider authorised by Monidor.
  • Page 20: Cleaning

    6 CLEANING 6 Cleaning Wipe the surface clean using a piece of cloth and a mild soap-water solution. If required, disinfect the device using ApoWipe or a similar product. The device can also be disinfected as follows: • 80% isopropanol •...
  • Page 21: Warranty / Inspection And Maintenance / Training

    Regular maintenance has been performed regularly. Warranty • Monidor provides all Monidrop® W infusion monitors and acces- sories it has manufactured with a warranty of 12 months. The warranty covers installation and the replacement of defective parts if the defect is caused by a structural, manufacturing or material error.
  • Page 22 7 WARRANTY / INSPECTION AND MAINTENACE / TRAINING Periodic inspections: Check that the device is clean, undamaged and in an operating condition. Only use the device in accordance with this operating manual. The areas at the back of the device inside the white frames in the figure below are intended for the labels of hospitals or health care centres.
  • Page 23: Content Of The Delivery And Inspecting The Content / Recycling

    8 CONTENT OF THE DELIVERY AND INSPECTING THE CONTENT / RECYCLING 8 Content of the delivery and inspecting the con- tent / Recycling Content of the delivery Monidrop® W infusion monitor, charger, quick user guide Inspecting the content of the delivery Regardless of protective packaging, there may be transportation damage.
  • Page 24: Technical Specifications

    9 Technical specifications Device type Infusion monitor Classification (according to Internally powered medical device. Charger and device complies with class II requirements EN 60601-1) while connected to mains supply. Class (Directive 93/42/ EEC) Moisture protection Monidrop® W IP 52 (dustproof, protection against water dropping vertically or at a maximum angle of 15 degrees) (Charger IP 22)
  • Page 25 9 TECHNICAL SPECIFICATIONS Storage conditions: • 20 % … 85 % (of air humidity condensation) Relative humidi- ty, % -20 … +55 °C • Temperature 80 kPa … 106 kPa • Air pressure Battery type Li-ion-polymer Operation time Over 1 day Charge time Approx.
  • Page 26 9 TECHNICAL SPECIFICATIONS Manufacturer's instructions and declaration of electromagnetic compatibility Disturbance test Compatibility Electromagnetic environment – in- structions RF emissions Group 1 Monidrop® W only uses RF energy in internal functions. Therefore, it only has very low emissions, and CISPR 11 probably does not disturb any nearby electrical devices.
  • Page 27 9 TECHNICAL SPECIFICATIONS Manufacturer's instructions and declaration – electromagnetic inter- ference tolerance The Monidrop® W infusion monitor is intended for use in the electromagnetic envi- ronments defined below. The owner or user of the Monidrop® W infusion monitor and its parts must ensure that the device is used in such an environment. Electromagnetic environ- Interference Test level...
  • Page 28 9 TECHNICAL SPECIFICATIONS Note 1: Different testing values of standard IEC 60601-2-24 are indicated in the table. These testing values do not permit any hazardous interference, while interference is permitted using the lowest testing values of standard IEC 60601-1-2. Magnetic field at IEC 60601-2-24: 400 A/m Magnetic fields at a network...
  • Page 29 9 TECHNICAL SPECIFICATIONS Recommended distance between mobile and movable RF com- munications devices and the Monidrop® W infusion monitor The Monidrop® W infusion monitor is intended for use in electromagnetic environments where radiated RF emissions are controlled. The owner or user of Monidrop®...
  • Page 30: Operating Instructions For Accessories

    10 OPERATING INSTRUCTIONS FOR ACCESSORIES 10 Operating instructions for accessories Charger The Monidrop® W infusion monitor is equipped with a charger, with which the battery can be charged during the use of the device and when the device is not in use. The Monidrop®...
  • Page 31 10 OPERATING INSTRUCTIONS FOR ACCESSORIES Do not use outdoors. Do not operate where aerosol (spray) products are being used or where oxygen is being administered. The socket-outlet should be installed near the power supply and should be easily accessible. Do not unplug by pulling on cord. To unplug, pull on the plug, not on the cord.
  • Page 36 MONIDOR Version number 4.0 Monidor Oy Elektroniikkatie 3 Approved: 02/04/2020 90590 Oulu Finland +358 10 3115 860 www.monidor.com...

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