CARPEDIEM Operators Manual SW1.5-0 Nov 2020

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Copyright Information The information contained in this manual is the sole property of Bellco S.r.l. and may not be duplicated without permission. © 2018 Bellco S.r.l.. All rights reserved. CARPEDIEM CARDIO PEDIATRIC DIALYSIS EMERGENCY MACHINE and CARPEDIEM CARDIO RENAL PEDIATRIC DIALYSIS EMERGENCY MACHINE are trademarks of Bellco S.r.l., ™ Third party brands are trademarks of their respective owners.

This manual may be revised or replaced by Bellco at any time and without notice. Ensure this manual is the most current applicable version. If in doubt, contact Bellco’s technical support. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The CARPEDIEM should be operated and serviced only by trained professionals. Bellco’s sole responsibility with respect to the CARPEDIEM, and its use, is as stated in the limited warranty provided. Nothing in this document shall limit or restrict in any way Bellco’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Bellco has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.

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CARPEDIEM Operator’s Manual - Bellco These operating instructions are solely intended for qualified personnel as the basis for using, operating, and maintaining the CARPEDIEM. Therefore, in the interest of the safety of both the patient and the operator: WARNING: Read these operating instructions thoroughly before using the CARPEDIEM. These operating instructions provide valuable information, even for the experienced user, including description of operational steps, and information on how to avoid dangerous situations and errors. For the rest of the manual, information intended to alert the user to potentially dangerous situations and to ensure correct and safe use of the equipment is indicated in the text in the following two ways: WARNING A “Warning” describes serious adverse reactions, potential safety hazards, and the resulting limitations in use imposed by these conditions, and the steps that should be taken should these conditions occur.

CAUTION A “Caution” includes information regarding any special care to be exercised by the practitioner and/or patient for the safe and effective use of equipment. This manual addresses qualified operators, medical staff of Cardiology, Internal Medicine, Dialysis, Paediatric and/or Neonatal Intensive Care Departments, and all persons who for reasons of role, expertise or appointment need to use CARPEDIEM to treat and manage fluid overload, electrolyte balance, Acute Kidney Injury and removal of dialyzable toxic substances. This manual contains all the information necessary for appropriate and proper use of CARPEDIEM. Do not interact with CARPEDIEM before having carefully read and understood these instructions in order to act correctly and safely. Operate only in accordance with the procedures published in this manual. For any questions or clarifications, you may need, do not hesitate to contact the manufacturer:

To contact After-sales / Technical Service: Tel.: +39 0535 29271 (Italy) Tel.: +39 0535 29402 (International) Fax: +39 0535 29400 e-mail: [email protected]

In the event that a serious incident has occurred related to device use, immediately report the event to Bellco and the competent authorities.

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CARPEDIEM Operator’s Manual - Bellco Table of Contents 1.

Introduction ... 13 1.1

Intended Use ... 13

1.1.1.

Intended Purpose ... 13

1.1.2.

Indications for Use... 13

1.1.3.

Patients Target Group ... 13

1.1.4.

Intended Users ... 13

1.1.5.

Limitations for Use ... 13

1.1.6.

Contraindications ... 13

1.2 Symbols on CARPEDIEM ... 14 1.3 Manufacturer's responsibilities ... 19 1.4 Storage ... 19 1.5 Disposal instruction ... 19 1.6 Warranty ... 20 1.7 Catalogue Number ... 20 1.8 Serial number... 20 1.9 Materials ... 20 1.10 Cautions and Warnings... 21 1.10.1 Cautions ... 21 1.10.2 Warnings... 23 1.11 Definition of terms and abbreviations ... 27 1.12 Clinical benefits ... 28 2.

General description and installation ... 29 2.1 General description ... 30 2.2 Equipment components ... 31 2.3 Control panel ... 33 2.4 Installation ... 34 2.5 Electrical connection ... 34 2.6 Battery ... 34 2.7 CARPEDIEM Preassembled device ... 35 2.7.1 Fluid bags ... 36

3.

Preparing the system and setting the technical parameter ... 37 3.1 Presentation ... 39 3.2 Technical parameters ... 40 3.3 Calibrations... 41

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CARPEDIEM Operator’s Manual - Bellco 3.3.1 Calibrate Scale ... 42 3.3.2 Calibrate Blood Leakage Detector... 43 3.3.3 Offset Dome ... 43 3.4 Line installation ... 43 3.5 Warmer ... 52 3.5.1 Biegler Warmer ... 53 3.6 Priming ... 55 4.

Treatment... 59 4.1 Clamp setting ... 59 4.2 Parameter setting ... 60 4.2.1 Treatment parameters ... 61 4.2.1.1 CVVH ... 61 4.2.1.2 CVVHD ... 62 4.2.2 Heparin parameters ... 64 4.3 Patient Connection... 65 4.3.1 Warmer warning ... 67 4.4 Treatment started ... 68 4.5 Treatment settings ... 69 4.6 Treatment data ... 72 4.6.1 Data service ... 74 4.7 Standby ... 74 4.8 Alarms and scales ... 75 4.8.1 Blood Leakage Detector calibration ... 76 4.8.2 Scales calibration ... 76 4.8.3 Bag change ... 77 4.9 Continuous heparin ... 80 4.9.1 Syringe change ... 81 4.10 Management of alarm 27 AIR IN THE VENOUS LINE ... 83 4.11 End Treatment ... 84 4.11.1 Blood return to the patient ... 85 4.11.2 Patient disconnection ... 87 4.11.3 Single use set uninstallation ... 88 4.12 Emergency conditions ... 89 4.12.1 Power restore ... 89 4.12.2 Equipment fault/power not restored ... 89

5.

Alarms ... 91

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CARPEDIEM Operator’s Manual - Bellco 5.1 Consulting the online HELP ... 93 5.2 Troubleshooting... 103 6.

Maintenance ... 105 6.1 Scheduled maintenance ... 105 6.2 Cleaning and disinfection ... 105 6.2.1 Cleaning procedure ... 105 6.2.1.1 Pre-treatment at the point of use ... 105 6.2.1.2 Cleaning procedure steps ... 106 6.2.2 Disinfection procedure ... 112

7. Electromagnetic compatibility... 113 8. Technical characteristics and performance ... 117 9. CARPEDIEM System components ... 123

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CARPEDIEM Operator’s Manual - Bellco List of figures Figure 1: CARPEDIEM front view ... 31 Figure 2: CARPEDIEM rear view... 32 Figure 3: Control panel ... 33 Figure 4: PRESENTATION page ... 39 Figure 5: TECHNICAL PARAMETERS page ... 40 Figure 6: TECHNICAL PARAMETERS page (language setting) ... 41 Figure 7: CALIBRATIONS page ... 41 Figure 8: SCALE CALIBRATION page ... 42 Figure 9: BLD CALIBRATION page ... 43 Figure 10: PREASSEMBLED DEVICE INSTALLATION page (CVVH) ... 44 Figure 11: PREASSEMBLED DEVICE INSTALLATION page (CVVHD)... 45 Figure 12: Preassembled device set ... 46 Figure 13: Cone in INF/DIA solution bag ... 47 Figure 14: Blood pump segment ... 48 Figure 15: INF/DIA pump segment... 48 Figure 16: Effluent pump segment ... 49 Figure 17: Focus on PRE, POST and DIA labels ... 51 Figure 18: WARNING: CHECK CLIPS page (CVVH) ... 51 Figure 19: WARNING: CHECK CLIPS page (CVVHD) ... 52 Figure 20: Biegler BW685 warmer installation... 53 Figure 21: Biegler BW685 warmer connection – step 1 ... 54 Figure 22: Biegler BW685 warmer connection – step 2 ... 54 Figure 23: Biegler BW685 warmer connection – step 3 ... 54 Figure 24: Biegler BW685 warmer connection – step 4 ... 55 Figure 25: Biegler BW685 warmer - equipotential cable connection ... 55 Figure 26: PRIMING STARTED page (CVVH) ... 56 Figure 27: PRIMING STARTED page (CVVHD) ... 56 Figure 28: PRIMING STARTED page: ADJUST VENOUS CHAMBER LEVEL ... 58 Figure 29: CLAMP SETTING page (CVVH) ... 59 Figure 30: CLAMP SETTING page (CVVHD) ... 60 Figure 31: TREATMENT SETTINGS page (CVVH) ... 61 Figure 32: TREATMENT SETTINGS page (CVVHD) ... 62 Figure 33: HEPARIN PARAMETERS page ... 64 Figure 34: PATIENT CONNECTION page (CVVH)... 65 Figure 35: PATIENT CONNECTION schematic (CVVH) ... 65 Figure 36: PATIENT CONNECTION page (CVVHD) ... 66 Figure 37: PATIENT CONNECTION schematic (CVVHD) ... 66 Figure 38: WARMER WARNING page ... 67 Figure 39: TREATMENT page ... 68 Figure 40: TREATMENT SETTINGS page (CVVH) - treatment ... 69 Figure 41: TREATMENT SETTINGS page (CVVHD) – treatment ... 70 Figure 42: TREATMENT DATA page (CVVH) ... 72 Figure 43: TREATMENT DATA page (CVVHD) ... 73 Figure 44: DATA SERVICE page ... 74 Figure 45: ALARMS AND SCALES page ... 75 Figure 46: ALARMS AND SCALES page – BLD calibration ... 76 Figure 47: ALARMS AND SCALES page – Scales calibration ... 77 Figure 48: BAG CHANGE page ... 78 IB5332945ENG_ SW_1.5-0 Release date:11/2020

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CARPEDIEM Operator’s Manual - Bellco Figure 49: EFFLUENT BAG CHANGE page (CVVH) ... 78 Figure 50: INFUSION BAG CHANGE page (CVVH) ... 79 Figure 51: EFFLUENT BAG CHANGE page (CVVHD) ... 79 Figure 52: INFUSION BAG CHANGE page (CVVHD)... 80 Figure 53: HEPARIN PARAMETERS page - treatment ... 80 Figure 54: SYRINGE CHANGE page ... 82 Figure 55: AIR IN THE VENOUS LINE page ... 83 Figure 56: TREATMENT END page ... 84 Figure 57: BLOOD RESTITUTION page ... 85 Figure 58: BLOOD RETURN schematic (CVVH) ... 85 Figure 59: BLOOD RETURN schematic (CVVHD) ... 86 Figure 60: BLOOD RETURN page ... 86 Figure 61: PATIENT DISCONNECTION page ... 87 Figure 62: SINGLE USE SET UNINSTALLATION page ... 88 Figure 63: PRESENTATION page (end of treatment)... 88 Figure 64: Emergency procedure-step 2... 90 Figure 65: Emergency procedure-step 4... 90 Figure 66: Emergency procedure-step 5... 90 Figure 67: Cleaning GUI ... 106 Figure 68: Cleaning Pressure Transducer - 1 ... 106 Figure 69: Cleaning Pressure Transducer - 2 ... 107 Figure 70: Cleaning Electroclamp -1... 107 Figure 71: Cleaning Electroclamp -2... 107 Figure 72: Cleaning Air Detector -1 ... 108 Figure 73: Cleaning Air Detector -2 ... 108 Figure 74: Cleaning Blood Leakage Detector -1 ... 108 Figure 75: Cleaning Blood Leakage Detector -2 ... 109 Figure 76: Cleaning Blood Pump -1 ... 109 Figure 77: Cleaning Blood Pump -2 ... 109 Figure 78: Cleaning Blood Pump -3 ... 109 Figure 79: Cleaning Blood Pump -4 ... 110 Figure 80: Cleaning Syringe Pump ... 110 Figure 81: Cleaning filter holder ... 110 Figure 82: Cleaning Venous Chamber Holder ... 111 Figure 83: Cleaning Clip for the venous line -1 ... 111 Figure 84: Cleaning Clip for the venous line -2 ... 111 Figure 85: Cleaning Machine Body... 111 Figure 86: Disinfection of GUI ... 112 Figure 87: Disinfection of Machine Body ... 112

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CARPEDIEM Operator’s Manual - Bellco List of tables Table 1: Shipping carton symbols ... 14 Table 2: Equipment symbols description ... 16 Table 3: Definition of terms and abbreviations ... 27 Table 4: Preassembled device description ... 35 Table 5: Priming parameters ... 57 Table 6: Treatment settings (CVVH) ... 61 Table 7: Treatment settings(CVVHD) ... 63 Table 8: Heparin parameters... 64 Table 9: Treatment parameter (TREATMENT page) ... 68 Table 10: Treatment settings (CVVH - treatment) ... 69 Table 11: Treatment settings (CVVHD - treatment) ... 71 Table 12: Treatment Data (CVVH) ... 72 Table 13: Treatment data (CVVHD) ... 73 Table 14: Alarm and Scales parameters ... 75 Table 15: Heparin parameters... 81 Table 16: Blood return parameters ... 87 Table 17: Message class ... 92 Table 18: Alarms description ... 93 Table 19: IEC 60601-1-2:2014 REQUIREMENTS ... 113

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1. Introduction

1.1 Intended Use The CARPEDIEM system is intended for continuous renal replacement therapy (CRRT) for paediatric patients weighing 2.5 kilograms or more. 1.1.1. Intended Purpose Haemodialysis and haemofiltration equipment is used for renal replacement therapies (RRT) to purify blood and treat fluid excess 1.1.2. Indications for Use The CARPEDIEM system is indicated for use in extracorporeal blood treatment of paediatric patients weighing 2.5 kg or more with acute kidney injury, fluid overload, and/or electrolyte disorders, requiring haemodialysis, haemofiltration, or ultrafiltration/fluid removal. 1.1.3. Patient Target Group Paediatric patients weighing 2.5 kg or more with acute kidney injury, fluid overload, and/or electrolyte disorders. 1.1.4. Intended Users Operators trained in the administration of continuous renal replacement therapy and in the management of its complications. 1.1.5. Limitations for Use Do not use CARPEDIEM if patient treatment requires performance outside its operating and accuracy range as well as the operating limits specified in this manual. CARPEDIEM allows using the anticoagulation method with heparin only. 1.1.6. Contraindications There are no contraindications to the use of CARPEDIEM equipment, unless it is modified or used for any purpose other than those specified or intended. For contraindications that may apply to the preassembled device selected for the therapy, refer to the Instructions For Use of the preassembled device.

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CARPEDIEM Operator’s Manual - Bellco 1.2 Symbols on CARPEDIEM The following symbols are applied on CARPEDIEM: Table 1: Shipping carton symbols

Symbol

Description

Medical device

Manufacturer

Catalogue number

Serial number

Date of Manufacture

Keep dry

This side up

Fragile, handle with care

Keep away from sunlight

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Temperature limit

Humidity limitation

Atmospheric pressure limitation

Do not stack

Consult instructions for use

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CARPEDIEM Operator’s Manual - Bellco Table 2: Equipment symbols description

Symbol

Description

Catalogue number

Serial number

Manufacturer

Date of Manufacture

Medical device

TYPE CF Applied part

Compliance with the Medical Devices Regulation (EU) 2017/745

V

Volt, unit of measure

Hz

Hertz, unit of measure

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A

Ampere, unit of measure

Separate collection for Electrical and Electronic Equipment

General warning sign

Refer to the instructions for use

Warning, electricity

Equipotentiality

Earth (ground)

Machine weight, including safe working load

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Alternating current

Off (no power)

On (powered)

Pushing prohibited

Dialysis fluid or infusion fluid bag scale

Effluent bag scale

cMETus approval mark

Degree of protection against penetration of solids and/or liquids: protected against vertically falling water drops

CVVH pre-infusion (applied on CARPEDIEM Preassembled device)

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CVVH post-infusion (applied on CARPEDIEM Preassembled device)

CVVHD (applied on CARPEDIEM Preassembled device)

1.3 Manufacturer's responsibilities The manufacturer is responsible for the safety, reliability and service of the equipment provided it is used in accordance with the instructions contained in this manual and if the electrical connections are in compliance with the regulations in force. All the maintenance or repair operations and the periodic checks must be carried out exclusively by the manufacturer technical service staff in accordance with the technical manual. WARNING: No modification of this equipment allowed.

1.4 Storage When not in use, it is advisable to store the CARPEDIEM equipment in a dust and dirt-free place away from adverse atmospheric agents and covered with a protective cover.

1.5 Disposal instruction

WARNING: Do not dispose in waste. Recycle in compliance with electronic recycling requirements. The estimated equipment service life is 10 years from the month of manufacture. To safeguard, protect and improve the quality of the environment and to protect human health, at the end of useful life, the equipment must be disposed of as special waste and be collected separately in observance of the national regulations in force. Discarded electromedical equipment must not be disposed together with municipal waste but must be collected separately in order to guarantee ecologically correct disposal to prevent dispersion of potential pollutants into the environment. The equipment to be disposed of must be returned to the manufacturer appropriately disinfected and accompanied by a declaration stating that the equipment is NOT infected. Disinfection of the machine must be performed, and the declaration written by the hospital and signed by a person officially appointed by the hospital. The manufacturer will not collect equipment that has not been disinfected, nor equipment that is not accompanied by signed declaration. IB5332945ENG_ SW_1.5-0 Release date:11/2020

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For the auxiliary power supply of the electronic circuits of the audible alarm, the CARPEDIEM system uses a lithium battery and a rechargeable Nickel-MH battery; follow the regulations in force for their replacement and disposal. The CARPEDIEM packaging material must be disposed of according to the regulations in force in the individual countries of sale. If for any reason this product must be returned to the company, the instructions to do so may be obtained from Customer Service (Tel: +39 0535 29271 Italy, Tel: +39 0535 29402 International, Email: [email protected]). Medtronic Customer Service or the Returned Goods Department must authorize all returns. All Product returns must be sent freight prepaid unless prior approval is granted. Customer Service will assign a Product Return Authorization Number and will forward a copy of the ProductReturn Authorization to the appropriate Customer contact along with return instructions.

1.6 Warranty To obtain warranty information for a covered product, contact a Bellco/Medtronic representative.

1.7 Catalogue Number The catalogue number is made up of 9 alphanumerical characters. - IB7010200: 220-240V~, 50/60 Hz - IB7010250: 110-120V~, 50/60 Hz

1.8 Serial number The serial number is made up of 8 numerical characters. For example: 5

6

y

y

x

x

x

x

The first two digits (56) indicate the CARPEDIEM equipment. yy indicates the year of equipment manufacture. xxxx is a progressive number.

1.9 Materials OUTER MATERIALS OF THE EQUIPMENT BAYDUR 67 VETRONITE NYLON DELRIN PVC ABS SILICONE AISI 303 STAINLESS STEEL AISI 316 STAINLESS STEEL PET IB5332945ENG_ SW_1.5-0 Release date:11/2020

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