P1000 Enteral Pump Operators Manual Ver 4.0 Dec 2018

For this Operator’s Manual, the issue date is 2018-12. Version: 4.0

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Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.

Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.

Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your equipment.

Conventions    

Italic textis used in this manual to quote the referenced chapters or sections. [ ] is used to enclose screen texts. <> is used to enclose the keys. → is used to indicate operational procedures.

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Contents 1 Safety ...1-1 1.1 Safety Information ...1-1 1.1.1 Dangers...1-1 1.1.2 WARNING ...1-2 1.1.3 CAUTION ...1-3 1.1.4 NOTE ...1-4 1.2 Equipment Symbols ...1-4 2 Overview ...2-1 2.1 Description ...2-1 2.1.1 Indications for Use ...2-1 2.1.2 Contraindications ...2-1 2.1.3 Appearance, Parts and Features ...2-1 2.2 Host ...2-2 2.2.1 Front View ...2-2 2.2.2 Rear View...2-4 2.2.3 Side View ...2-4 2.2.4 Bottom View ...2-5 2.3 Screen Display ...2-6 2.4 Cursor ...2-6 3 Installation and Setting...3-1 3.1 Installation ...3-1 3.1.1 Out of Box Audit (OOBA) ...3-2 3.1.2 Operating Conditions ...3-2 3.1.3 Mount the Clamp ...3-3 3.1.3.1 Standard Pole Clamp...3-3 3.1.3.2 Advanced Pole Clamp (Optional) ...3-4 3.1.4 Connect the AC Power Source ...3-4 3.2 Conventional Settings ...3-4 3.2.1 Set Language...3-5 3.2.2 Adjust Screen Brightness ...3-5 3.2.3 Set Date and Time ...3-5 3.2.4 Adjust Volume ...3-5 3.3 Restore Factory Default ...3-5 4 Basic Operation...4-1 4.1 Infusion Flow Chart ...4-1 4.2 OperationalProcedures ...4-2 4.2.1 Turn on the Pump ...4-2 4.2.2 Insert the Enteral Syringe...4-2 1

4.2.3 Change the Enteral Syringe ...4-3 4.2.4 Confirm the Enteral Syringe ...4-4 4.2.5 Memory Function ...4-4 4.2.6 Rate Mode...4-4 4.2.7 Purge...4-5 4.2.8 Set Infusion Parameters...4-6 4.2.9 Infusion...4-7 4.2.10 Infusion Pause ...4-7 4.2.11 BOLUS ...4-7 4.2.12 Change the Rate during Operation ...4-8 4.2.13 Complete ...4-8 4.2.14 Standby ...4-8 4.2.15 Turn off the Pump ...4-9 5 Setting Parameters ...5-1 5.1 Occlusion Pressure (unit) ...5-1 5.1.1 Set Occlusion Pressure...5-1 5.1.2 Set Unit of Pressure ...5-1 5.1.3 Dynamic Pressure Scanning (DPS) ...5-2 5.1.4 Automatic Pressure Release Function (Anti-Bolus) ...5-2 5.2 Key Lock Function...5-2 5.3 Reminder Function ...5-3 5.4 Time Near End ...5-3 5.5 Bed No. Settings ...5-3 6 Other Functions ...6-1 6.1 Record...6-1 6.2 Power-down Save ...6-1 6.3 Nurse Call ...6-1 6.4 Data Export ...6-2 7 Alarms ...7-1 7.1 Alarm Level ...7-1 7.2 Alarm Types ...7-1 7.2.1 Multi-level Alarm Rules ...7-2 7.3 Alarm Handling Rules ...7-2 7.4 Alarm Countermeasures ...7-3 8 Battery ...8-1 8.1 Battery Performance Optimization ...8-1 8.2 Check the Battery...8-2 8.3 Battery Recycling ...8-3 9 Preservation and Sanitation...9-1 2

9.1 Description ...9-1 9.2 Cleaning ...9-1 9.3 Disinfection...9-2 10 Maintenance ...10-1 10.1 Inspection ...10-1 10.2 Maintenance Plan ...10-1 10.3 View Information ...10-2 10.4 Syringe Calibration ...10-2 10.5 Safe Disposal and Recycling ...10-2 11 Accessories ...11-1 A Product Specifications ...A-1 A.1 Safety Specifications ...A-1 A.1.1 Product Classification ...A-1 A.1.2 Operating Environment...A-2 A.2 Physical Specifications ...A-2 A.3 Hardware Specifications...A-3 A.3.1 Display ...A-3 A.3.2 Battery ...A-3 A.3.3 Host LED ...A-3 A.3.4 Auditory Indicator...A-3 A.3.5 External Ports ...A-4 A.3.6 Signal Output Interface ...A-4 A.4 Specifications ...A-5 A.5 A Reference Table Showing Occlusion Alarm Delay and Possible Dose ...A-7 A.6 Infusion Accuracy Curve ...A-8 A.7 Trumpet Curve ...A-9 B EMC ...B-1 C Default Factory Settings...C-1 C.1 Alarms ...C-1 C.2 Interface ...C-1 C.3 Parameters ...C-1 C.4 System Time ...C-2 D Alarm Information ...D-1 E Symbols and Terms ...E-1 E.1 List of Units...E-1 E.2 List of Symbols ...E-2 E.3 List of Terms...E-2 3

E.4 List of Unit Conversion ...E-3 F Toxic and Hazardous Substances or Elements ...F-1

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1 Safety 1.1 Safety Information The safety statements presented in this chapter refer to basic safety information that the operator must pay attention to and abide by when using the enteral pump.There are additional safety statements in other chapters or sections, which may be the same as or similar to the following, or specific to particular operations.

Dangers 

Indicates an imminent hazard that, if not avoided, could result in death, serious injury or damage to product/property.

WARNING 

Indicates a potential hazard or unsafe practice that, if not avoided, could result in death, serious injury or damage to product/property.

CAUTION 

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury, product malfunction or damage to product/property.

NOTE 

Provides application tips or other useful information to ensure that you get the most out of the product.

1.1.1 Dangers This Manual does not contain any information at the "Danger" level.

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1.1.2 WARNING WARNING 

Device, cables and accessories must be inspected before use to guarantee their normal and safe operation.



This equipment can only be connected to the socket with ground protection. Please adopt a rechargeable battery instead of the socket as the power supply if the socket is not provided with a ground lead.



To prevent fire or explosion, do not operate the equipment in the presence of anesthetic, flammable or explosive materials.

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Do not open the equipment casing as there is the impending danger of electric shock.Equipment maintenance and upgrades must be carried out by maintenance technicians whom are trained and licensed by the manufacturer. Moreover, the process must be done only after the AC power supply is disconnected.Maintenance carried out by individuals non-affiliated to the manufacturer or by non-licensed personnel may affect the safety, performance and function of the product.

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When used with electrosurgery equipment, the safety of patients should be ensured.

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The patient's clinical condition and the working condition of the enteral pump must be monitored carefully, and the alarm volume and alarm levels need to be set according to the actual needs.Operation and performance relying solely on the auditory alarm system alone is not sufficient, and setting the alarm at a low volume may endanger the patient. If the alarm volume is less than the surroundings volume, which can further lead to operators identify alarm mistakenly.

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Please carefully install the power line and cables with various accessories to prevent the patient from choking or suffocation caused by entanglement of the cables or by electrical disturbance.

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The packaging materials must be disposed of in compliance with local laws and regulations or the hospital policy on waste management.They must be kept out of the reach of children.

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The pump should not be placed more than 100cm above or below the level of the patient’s heart. The smaller the height difference between the pump, the more accurate the pressure test in the infusion set will be.

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Do not touch the patient when connecting the peripheral equipment via the input/output signal ports to prevent patient leakage current from exceeding the requirements specified by the standard.

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In the process of defibrillation, do not touch patient and other

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non-defibrillation equipments to prevent electric shock damage, and defibrillation will not affect the basic performance (such as infusion accuracy, alarm and signal transmission) of the pump.

1.1.3 CAUTION CAUTION 

Use the accessories specified in this Operator’s Manual to guarantee the patient’s safety.

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When equipment and the accessories exceed their recommended service life, they must be disposed of in accordance with local statutes or hospital regulations.

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Electromagnetic fields may affect equipment performance. This makes it necessary for other equipment used in the vicinity of the pump to meet EMC standards.Mobile phones, X ray and MRI equipment are all potential interference sources because of their high-intensity electromagnetic radiation.



Before the equipment is connected to the power supply, check that the voltage and frequency of the power supply match the specifications on the label or in this Operator’s Manual.

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Please install and carry the equipment correctly to protect the equipment from damage from drops, impacts, violent shaking or other external mechanical forces.

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Disposable accessories must be disposed of after use in accordance with the relevant hospital regulations.

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Avoid direct sunshine, high temperatures and dampness.

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Check the built-in battery before use to make sure it has sufficient power.Recharge the battery if necessary.

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The syringe must be an ENFit enteral syringe. For the 60 ml syringes, the max position is 50ml.

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1.1.4 NOTE NOTE 

Install the equipment in a position where it can be easily accessed for inspection, operation and maintenance.

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Keep this Operator’s Manual near to the equipment for future ease of reference.

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The software of the equipment is developed according to the software development demands of IEC60601-1 standard, which can minimize the possibility of the risk caused by program error.

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This Operator’s Manual describes the most complete functional configuration of the equipment. The product you are using may not have some of the settings or functions described herein.

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Do not insert devices that are not specified by the manufacturer into the multifunction interfaces.

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During infusion, the enteral pump can accurately control the rate, infusion volume and infusion time, and monitor the operation in real-time, to effectively prevent over currents, under currents and instances of backflow.

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The device is not in touch with the drugs or patients directly. Thus, there is no need to process Biocompatibility test on it.

1.2 Equipment Symbols The equipment you purchased may not provide you with all the following symbols. NOTE！ Refer to the accompanying document (This Manual)

ON/OFF

Caution

Syringe

Alternating current power supply (AC)

Battery

Alarms

AUDIO PAUSED

Clear/Back

Start

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Bolus

Confirm

Stop

Menu

Move up/Increase

Move down/Decrease

Move left

Move right

The European Union Representative Office

Wireless transceiver

Lock

Multifunction interface

Night mode

Protected against defibrillation CF applied parts

Date of manufacture

Manufacturer

This side up

Keep away from rain

Fragile, handle with care

Stacking limit by number

Electronic equipment: dispose of separately to avoid polluting the environment

Protected against solid foreign objects with a diameter no less than 2.5mm and protected against spraying liquid water

IP34

Environmentally-friendly use periods of electronic products (20 years)

Serial number

Recycle

CE mark

Package shall be kept between 50–106 kPa during transport

Package shall be kept between 10%–95% humidity during transport

Package shall be kept between -40–70°C during transport

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2 Overview 2.1 Description 2.1.1 Indications for Use The enteral pump is used in conjunction with the syringe to control the dose of enteral feeding. The enteral pump is suitable for adults, children and newborns in clinical departments. This enteral pump is expected to be used in institutes or units with healthcare capabilities. This includes but is not limited to:outpatient departments, emergency departments, wards, ICU, operating rooms, observation rooms, clinics, nursing hospital, neonatal units and SCBU.

WARNING 

The enteral pump is for clinical use. It must only be used under appropriate conditions by professional clinicians, medical device technicians, or by suitably trained nurses.Personnel using this product must receive sufficient training.This product must not be operated by anyone who has not been authorized to do so or has not received suitable training.

2.1.2 Contraindications None

2.1.3 Appearance, Parts and Features The enteral pump primarily consists of a housing and pole clamp. By precisely controlling the rotational speed of the stepping motor, the screw rod is driven to run at the set speed, the dose of liquid infused into the patient’s body by syringe can be controlled, the enteral pump can be used for precise and continuous infusion of liquids, and all components are suitable for use in patient environment. Functions of the software comprise Rate Mode, History Record, and Anti-bolus Function.

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Since some parts and functions are optional, the enteral pump you purchased may not contain these additional parts and their relevant functions.

2.2 Host 2.2.1 Front View

1. Alarm light The alarm light indicates different alarm levels in different colors and flash frequencies, please refer to Chapter 8 Alarms for details. 2. Display Used for displaying infusion parameters and relevant content. 3. <DIRECTION> Used for adjusting value, change lines and pages. 4. <CLEAR/BACK>  Under non-setting status, indicate to return to the previous menu or operation.  Under the setting status, indicate to clear the current set or cancel the edit. 5. <OK> Used for confirming input operation and saving value. 6. <START> After installing the syringe correctly and completing setting infusion parameters, press this key to start the infusion. 7. <STOP> During infusion, press this key to stop infusion.Infusion stops caused by alarms, such as occlusion and so on, press this key to cancel the alarm. 8. <BOLUS >  During infusion, press this key to start fast infusion.  When the pump is stopped, press this key to purge. 2-2

9. <AUDIO PAUSED> Pauses alarm sound. 10. <POWER>  Used for turning power on, entering in standby state and turning off operations.  When power off, press and hold (>3 s) the key. 11. <MENU>  Under non-operation status, used for switching [Main Menu] interface and other interfaces.  Under operation status, press and hold this key to lock; in locked state, press and hold to unlock. 12. AC/DC indicator light  On:The pump is connected to an AC/DC power supply (including shutdown).  Off:The pump is not connected to an AC/DC power supply. 13. Extension set clamp Fixes the extension set. 14. Syringe fixation clamp 15. Battery indicator  Steady green indicates that the battery is charging (including shutdown).  Flashing indicates that the battery is providing power.  Light off indicates that there is no battery or the pump is turned off and not connected to an AC power supply. 16. Slider Secures syringe and drives plunger assembly. 17. Handle

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2.2.2 Rear View

1. Product label 2. Pole clamp mounting holes (two) 3. Alternating current power supply (AC) port Connected by three-core-type power cord and AC power source. 4. Multifunction interface, which combines the following interface functions:  DC power input interface  RS232 interface  Nurse call interface

2.2.3 Side View

1. Handle 2. Extension set clamp

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1. 2. 3. 4. 5. 6.

Clip Syringe fixation clamp Slot Spindle clamp Slider Handle

2.2.4 Bottom View

1. Multi-channel pumps connection slot 2.Speaker hole

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2.3 Screen Display This enteral pump has a monochrome LCD screen. The display information comprises three main parts: 1

1

2

2

3

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1. Title bar Display current infusion mode, alarm information, battery icon, and etc. 2. Parameter area Display every parameter and the parameter value of the current screen. 3. Prompt bar Display run icon and so on.The run icon on the screen displays the running operation: The icon indicates normal running. Arrows move from right to ■ left, and the running speed increases as the rate is increased. Motor stops caused by alarms during infusion, no icon.

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2.4 Cursor In the main screen and parameter settings screen, when the cursor is located at an option or at a data value, the grounding of the option or the data value will turn to white and the font will become blue.Press and confirm the location. Press

or

to move cursor up and down

to select the option or data value for further

operation.

Note: Press

or

to "locate" cursor; Press

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to "Select".

3 Installationand Setting 3.1 Installation WARNING 

Equipment assembly and refit (including correct protective grounding connection) during life period must be carried out by maintenance technicians whom are trained and licensed by the manufacturer, and evaluated according to the specified IEC60601-1. Please contact the company if you have any queries.

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The software copyright for this equipment belongs to the manufacturer. Unless explicitly authorized, any alteration, reproduction or sale by any means or in any form by any organization or individual is prohibited.

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All the analog equipment and digital facilities should be certified according to the specified IEC standard (such as:IEC60950 Information Technology Equipment Safety and IEC60601-1 Medical Electrical Equipment Safety). Moreover, all equipment should be connected based on the requirements of the valid version of the IEC60601-1 system.The qualified individual responsible for connecting auxiliary equipment to the input and output signal ports is also accountable for making the system in accordance with the IEC60601-1 standard.Please contact the company if you have any queries.

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When this equipment combining with other electrical equipments forms a combination with a special function, and the user cannot determine whether there is an impending danger from each equipment specification (such as a danger of electric shock due to aggregation of current leakage), please contact the company or a specialist in the field at the hospital, to guarantee that all equipment in the combination are safe enough and will not be damaged.



Please make sure this equipment is securely fixed and positioned. Positioning changes and severe shock can lead to minor changes in the delivery accuracy.

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NOTE 

Removing power cord is to disconnect equipment from power supply. Please ensure suitable clearance around the equipment to facilitate connect and remove power cord.



This equipment is in accordance with the EN 1789:2007+A1:2010 standard. It can be fixed on cross bar (square cross bar: 10 x 25 mm) or vertical bar (round vertical bar with diameter size of 15-38mm) ofambulance with advanced pole clamp. Please refer to 3.1.3.2Advanced Pole Clamp (Optional) for detailed operation of advanced pole clamp.

3.1.1 Out of Box Audit (OOBA) Please check the packing case carefully before opening the box.If there is any damage, please contact the distributor or manufacturer immediately.

NOTE 

Keep the packing case and packaging materials for future transportation or storage.

WARNING 

The packaging materials must be kept out of the reach of children.They must be disposed of in compliance with local laws and regulations or the hospital policy on waste management.



The equipment may be contaminated by microbes during storage, transport and use. Please ensure that the package is undamaged before using, do not use if there is any damage.

3.1.2 Operating Conditions The operating environment of this enteral pump must meet the requirements in A.1.2 Operating Environment. The operating environment should also be appropriately protected from noise, vibration, dust, and corrosive, inflammable or explosive substances.If installed inside the equipment case, a sufficient space before and after the equipment case should be ensured to facilitate operation, maintenance and repairing work.There should be a 2" (5 cm) gap around the enteral pump to ensure that air can circulate freely for a better cooling effect. 3-2