1.1.1.1 Dimensions
- 17” (43.18cm) W x 23” (58.42cm) H x 17” (43.18cm) D without Drip Tray
- Drip Tray: 9.29” (23.6cm) D x 17” (43.18cm) W
1.1.1.2 Weight
- 44 lbs. (18Kg)
1.1.1.3 Requirements
a. Water
- Recommended to meet AAMI Standard for Hemodialysis Systems as required by the AAMI Recommended Practice for Reuse of Hemodialyzers
- Pressure: 35psi (2.4bar) to 50psi (3.75bar) dynamic
- Flow: 0.8GPM (3l/min) maximum
b. Drain
- Must accept a minimum flow of 1GPM (3.78l/min)
- Must be placed no higher than 10” (25.4cm) below the bottom of the MAKY 21.1
c. Electrical
- 90 / 260V
- 50 / 60 Hz
- 200 W
- FUSE RATING: T3.15 AMP
1.1.1.4 Consumption
a. Water: 5.5 to 7.2 l (If same chemical agents used for cleaning and disinfection)
a. Cleaning Agent: 14 / 18 ml (STD, HE / HF when 2% of dilution factor is set)
b. Disinfecting Agent: 32 / 42 ml (STD, HE / HF when 3.5% of dilution factor is set)
1.1.1.5 Environmental Limits
a. Operation Ambient temperature range: 50F (10C) to 100F (38C)
b. Relative Humidity: 10 to 80%
1.1.1.6 Standards
CSA C22-2 No1010.1-92
1.1.1.7 Tests
a. Total Cell Volume Test (TCVT):
- The volume of the Blood Compartment is electronically measured and checked to be at least 80% of the original value.
- Repeatability (standard deviation value): 3%.
- Alarms: Variation from previous value <> 15% **
Current value < 80% original value *
* This value may be reprogrammed to a higher percentage.
** This value may be programmed to a lower value.
b. Membrane Integrity Test (MIT):
- The Blood Compartment is positively pressurized up to 300mmHg while the dialysate side is left open to atmosphere. According to the program selected (0.83mmHg/s +/- 10% for Standard and High Efficiency Programs or 1.25mmHg/s +/- 10% for High Flux) the acceptable pressure drop after 30 seconds or 20 seconds respectively, is checked.
If the TCVT fails, the MIT is not done. Both tests must be passed successfully to disinfect the dialyzer.
1.1.1.8 Programs
- STD / STD+: 10min to 17min to rinse, clean, test and disinfect standard dialyzers.
- HE / HE+: 12min to 17min to rinse, clean, test and disinfect high efficiency dialyzers.
- HF / HF+: 12min to 17min to rinse, clean, test and disinfect high flux dialyzers.
- CU1 / CU2 / CU3: to be configured by HDC Maquinolas, LLC as directed by the prescribing physician (processing time must be longer than 10 min (STD) or 12 min (HE/HF)). They may also be programmed to be PRECLEANING Programs.
These times correspond to those cases where the same chemical agent is used for cleaning and disinfection.
1.1.1.9 Materials in contact with fluids
- Polypropylene
- Acrylic
- Silicone
- Stainless Steel
- Teflon
- FFPM
- PVDF
- ABS
- Tygon 3603
- PTFE
- Viton
1.1.1.10 Chemicals supported
Refer to TABLES 4-1 and 4-2, Page 4-7.
1.1.1.11 Peripheral ports
- EIA 232 for bar code scanner
- Centronics for the report printer
- EIA 232 for the label printer
- EIA 232 for PC
- EIA 485 for up to 10 MAKY 21.1 interconnections
- External Traffic Lights port
- External AT Keyboard port
1.1.1.12 Available Reports
Refer to Section 7 for Details on each of the following reports:
- TCVT results per dialyzer
- Reuses per patient (total and by date)
- Average reuse per patient (total and by date)
- List of Active Patients
- List of Preprocessed Dialyzers
- List of Brands
- List of Discard Causes
- List of Not Used Dialyzers
- Monthly Statistics
- Type Statistics
- Brand Statistics
- Discard Cause Statistics
- General statistics
1.1.1.13 Maximum Data Storage Capability
- Number of Dialyzers: 2000
- Number of Patients: 1000
- Number of Preprocessed Dialyzers: 2000
- Number of Dialyzers per Patient: 50
- Number of individual TCVT results: 20
- Number of Brands: 31
Note: Centralized Reprocessing facilities may require different storage capabilities. Contact HDC Maquinolas, LLC for further details.
1.2 Cleaning and Disinfectant Agents
In accordance with AAMI recommendations, all dialyzers should be tested with a presence or potency test to verify that appropriate levels of the disinfectant are present in the dialyzer before the dialyzer is prepared for patient use. Following the rinse or priming procedure, before the patient is put on dialysis, a residual or absence test should be performed to verify the disinfectant has been removed by the rinse procedure. Please refer to the labeling supplied by the manufacturer for information regarding the specific methodology recommended.
CAUTION: Only the disinfectants listed below are recommended for use in the MAKY 21.1 as a dialyzer disinfectant. Consult HDC Maquinolas, LLC for other possible agents.
Note: Only products approved and indicated for hemodialyzer disinfection may be used for reprocessing dialyzers with the MAKY 21.1. Please refer to the labeling supplied by the manufacturer for more information regarding their use.
Note: In accordance with AAMI recommendations, when using different chemicals for cleaning and disinfection, the previous agent must be rinsed before introducing the next chemical. When using diluted agents for both purposes, an RO water container must be connected to the Glutaraldehyde – Aux port to achieve the rinsing function.
Note: Institutional Formula 409 – Bleach is used to remove build-up of material and is not intended for disinfection of the system. HDC Maquinolas, LLC recommends that the procedure be performed approximately every 2 weeks.
Function Agent Inlet Dilution Comments
Cleaning Peracetic Acid* 100% The MAKY 21.1 will dilute it to a 2% solution **
Bleach 100% The MAKY 21.1 will dilute it to a 0.5% solution **
Disinfection Peracetic Acid* 100% The MAKY 21.1 will dilute it to a 3.5% solution **
Glutaraldehyde According to manufacturer’s recommendation The MAKY 21.1 WILL NOT dilute this agent. The OPERATOR SHOULD DILUTE IT. ***
Formaldehyde 100% The MAKY 21.1 will dilute it to a 4% solution **
Table Error! No text of specified style in document. 1 Dialyzer Chemical Agents
Function Agent Inlet Dilution Comments
System Disinfection Peracetic Acid* 100% The MAKY 21.1 will dilute it to a 3.5% disinfecting solution **
Bleach 100% The MAKY 21.1 will dilute it to a 1% disinfecting solution **
Institutional Formula 409 100% The MAKY 21.1 will dilute it to a 14.5% solution
Formaldehyde 100% The MAKY 21.1 will dilute it to a 4% disinfecting solution **
Table Error! No text of specified style in document. 2 System disinfection chemical agents
* Only peracetic acid products approved and indicated for dialysis may be used for reprocessing dialyzers with the MAKY 21.1.
** A prescribing physician may request higher or lower concentrations to HDC Maquinolas, LLC.
*** The MAKY 21.1 does not dilute GLUTARALDEHYDE solutions. HDC Maquinolas, LLC strongly recommends to follow the manufacturer’s instructions for dilution of the Glutaraldehyde solution.
CAUTION: WHEN USING FLAMMABLE LIQUIDS, SUCH AS FORMALDEHYDE, USER MUST ADHERE TO LOCAL AND NATIONAL REGULATIONS IN STORAGE, HANDLING, DISPENSING AND DISPOSAL OF THAT MATERIALS.
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